!"#$%#&'($)#*+$&,-./0.1&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&2##34&56(*7$#8&9$:;"%6& Novelty Standard for Anticipation - Accidental and Unknown Anticipations and the Doctrine of Inherency Schering vs.

. Geneva (2003)
Doctrines: Facts: Owner of patent for antihistamine metabolite sued manufacturers of generic versions for infringement. Schering Corporation (Schering) owns the 8233 and 8716 patents on antihistamines. Antihistamines inhibit the histamines that cause allergic symptoms. The prior art 8233 patent covers the antihistamine loratadine, the active component of a pharmaceutical that schering markets as CLARITIN. Unlike conventional antihistamines when CLARITIN was launched, loratadine does not cause drowsiness. The more recent 8716 patent at issue in this case covers a metabolite of loratadine called descarboethoxyloratadine (DCL). Ametabolite is the compound formed in the patients body upon ingestion of a pharmaceutical. The ingested pharmaceutical undergoes a chemical conversion in the digestion process to form a new metabolitecompound. The metabolite DCL is also a non-drowsy antihistamine. The 8716 pat-ent issued in April 1987 and will expire inApril 2004 (the 8233 patent issued in 1981and has since expired). Structurally, loratadine and its metabolite DCL differ only in that loratadine has a carboethoxy group (i.e., -COOEt) on a ring nitrogen, while DCL has a hydrogen atom on that ring nitrogen. The 8233 patent issued on August 4, 1981, over one year before the earliest priority date of the 8716 patent, February 15, 1984. The 8233 patent is thus prior art to the 8716 patent. A person shall be entitled to a patent unless TTT the invention was patented TTT in this or a foreign country TTT more than one year prior to the date of the application for patent in the United States.The 8233 patent discloses a class of compounds including loratadine. The 8233 patent claims loratadine in claim 7. The 8233 patent claims four other compounds in claims 811. The 8233 patent does not expressly disclose DCL and does not refer to metabolites of loratadine. The numerous defendants-appellees sought to market generic versions of loratadine once the 8233 patent expired. Seeking regulatory approval, each appellee submitted an application to the Food and Drug Administration (FDA). Because Schering included the 8716 patent in the Orange Book listing for loratadine, the applications also contained a certification that the 8716 patent was invalid. Issues: 1. W/N the 8716 patent is valid. 2. W/N the 8233 created anticipation. Held/Ratio: 1. NO. A patent is invalid for anticipation if a single prior art reference discloses each and every limitation of the claimed invention. Moreover, a prior art reference may anticipate without disclosing a feature of the claimed invention if that missing characteristic is necessarily present, or inherent,in the single anticipating reference. At the outset, this court rejects the contention that inherent anticipation requires recognition in the prior art. Inherent anticipation does notrequire that a person of ordinary skill in the art at the time would have recognized the inherent disclosure. Thus, recognition by a person of ordinary skill in the art before the critical date of the 8716 patent is not required to show anticipation by inherency. The district court therefore did not err in allowing for later recognition of the inherent characteristics of the prior art 8233 patent. Prior art reference may anticipate patent without disclosing feature of claimed invention if that missing characteristic is necessarily present, or inherent,in single anticipating reference.

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Cases dealing with accidental, unwitting, and unappreciated anticipation also do not show that inherency requires recognition. In contrast to the present case, the record in the cases of Eibel and Tilghman did not show that the prior art produced the claimed subject matter. The patent at issue in Tilghman claimed a method of forming free fattyacids and glycerine by heating fats withwater at high pressure. In Tilghman, the record did not show conclusively that the claimed process occurred in the prior art.In reviewing the prior art, the Court referred hypothetically to possible disclosure of the claimed process. For example, theCourt stated [w]e do not regard the acci-dental formation of fat acid in Perkinsssteam cylinder (if the scum which rose on the water issuing from the ejection pipe was fat acid) as of any consequence in this inquiry. In Eibel, the Court found no evidence of the claimed subject matter in the prior art. We find no evidence that any pitch of the wire had brought about such a result and if it had done so under unusual conditions, accidental results, not intended and not appreciated, do not constitute anticipation." In the context of accidental anticipation,DCL is not formed accidentally or under unusual conditions when loratadine is ingested. The record shows that DCL necessarily and inevitably forms from loratadine under normal conditions. DCL is a necessary consequence of administering lorata-dine to patients. The record also shows that DCL provides a useful result, because it serves as an active non-drowsy antihistamine. In sum, this courts precedent does not require a skilled artisan to recognize the inherent characteristic in the prior art that anticipates the claimed invention. In this courts prior inherency cases, a single prior art reference generally contained an incomplete description of the anticipatory subject matter, i.e., a partial description missing certain aspects. Inherency supplied the missing aspect of the description. Upon proof that the missing description is inherent in the prior art,that single prior art reference placed the claimed subject matter in the public do-main. This case does not present the is-sue of a missing feature of the claimed invention. Rather, the new structure in this case, DCL, is not described by the prior 8233 patent. Patent law nonetheless establishes that a prior art reference which expressly or inherently contains each and every limitation of the claimed subject matter anticipates and invalidates. Because inherency places subject matter in the public domain as well as an express disclosure, the inherent disclosure of the entire claimed subject matter anticipates as well as inherent disclosure of a single feature of the claimed subject matter.The extent of the inherent disclosure does not limit its anticipatory effect. In general, a limitation or the entire invention is inherent and in the public domain if it is the natural result flowing from the explicit disclosure of the prior art. This court sees no reason to modify the general rule for inherent anticipation in a case where inherency supplies the entire anticipatory subject matter. The patent law principle that which would literally infringe if later in time anticipates if earlier." The public remains free to make, use, or sell prior art compositions or processes, regardless of whether or not they under-stand their complete makeup or the under-lying scientific principles which allow them to operate. The doctrine of anticipation by inherency, among other doctrines, enforces that basic principle. Thus,inherency operates to anticipate entire inventions as well as single limitations within an invention. Turning to this case, the use of lorata-dine would infringe claims 1 and 3 of the 8716 patent covering the metabolite DCL.This court has recognized that a person may infringe a claim to a metabolite if the person ingests a compound that metabolizes to form the metabolite. An identical metabolite must then anticipate if earlier in time than the claimed compound. The record shows that the metabolite of the prior art loratadine is the same com-pound as the claimed invention. Claims 1and 3 are compound claims in which individual compounds are claimed in the alter-native in Markush format. DCL is within the scope of claims 1 and 3. Because theprior art metabolite inherently disclosedDCL, claims 1 and 3 are anticipated and invalid. In other words, the record shows that a patient ingesting loratadine would necessarily

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metabolize that compound toDCL. That later act would thus infringe claims 1 and 3. Thus, a prior art reference showing administration of loratadine to a patient anticipates claims 1 and 3. 2. YES. Before the critical date, Schering only tested loratadine in secret. Thus, according to Schering, DCL was not publicly used, or described in any printed publication, until after February 15, 1983, the critical date for the 8716 patent under 35U.S.C. 102(b). Schering thus argues that DCL did not exist in the publicdomain such that DCL could be prior art against the 8716 patent. Anticipation does not require the actual creation or reduction to practice of the prior art subject matter; anticipation requires only an enabling disclosure. Thus, actual administration of loratadine to patients before the critical date of the 8716 patent is irrelevant. The 8233 patent suffices as an anticipatory prior art reference if it discloses in an enabling manner the administration of loratadine to patients. Thus, this court examines whether the 8233 patent contains an enabling dis-closure of DCL. A reference may enable one of skill in the art to make and use a compound even if the author or inventor did not actually make or reduce to practice that subject matter. Indeed, information arising after the critical date may show that the claimed subject matter, as disclosed in a prior art reference, was in the publics possession. An anticipatory reference need only enable subject matter that falls within the scope of the claims at issue, nothing more.To qualify as an enabled reference, the8233 patent need not describe how to makeDCL in its isolated form. The 8233 patent need only describe how to make DCL in any form encompassed by a compound claim covering DCL, e.g., DCL as a metabolite in a patients body. The 8233 patent discloses administering loratadine to a patient. A person of ordinary skill in the art could practice the 8233 patent without un-due experimentation. The inherent result of administering loratadine to a patient is the formation of DCL. The 8233 patent thus provides an enabling disclosure for making DCL.

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Novelty - Known by Others National Tractor Pullers Association v. Watkins (1980) (Sled being pulled by tractors) Doctrines: Facts: Plaintiff association of tractor pullers, which organized and sanctioned contests nationally, challenged the validity of defendant's patent for a sled device designed to increase the resistance of a sled to being pulled. Plaintiff sought a declaration of non-infringement for obviousness, even though the patent had survived a contested reissue examination. Defendant argued its invention was entitled to pioneer status as the first purely mechanical sled that used the principle of moving a weight on spaced supports to generate the friction to stop the tractor. Defendant also argued plaintiff had induced infringement by requiring that sleds at its events must use infringing principles. The invention subject of this controversy is the "Power Stopper Weight Transfer Apparatus" invented by Watkins, and relates to devices commonly known as tractor pulling sleds. Such devices are used at pulling contests where competing tractor or truck owners test their machines against other machines by pulling a sled device down a track from a starting line towards a finish line. The sled device is designed to increase the resistance of the sled to being pulled in relation to the distance which the sled has been pulled from the starting line. The resistance eventually exceeds the pulling power of the contestants' machines and thereby brings those machines to a halt. In 1965 and prior thereto, the principal tractor pulling sled in use was known as a "step-on" or "man" sled, which consisted of a flat sheet metal pan with a chain connection to the draw bar of a tractor. The sled was started each time from a common starting line and was pulled by the competing tractor down a measured length track. As the sled was pulled from the starting line, people lined the track every five feet. As the sled moved past each person's position, that person stepped onto the sled thus increasing the weight on the sled until there was enough human weight on the sled to bring the tractor to a stop due to the frictional resistance of the sled to the ground. There were several deficiencies involved with "man" sleds. First, there were safety problems associated with people stepping on and riding a moving sled, which was subject to a sudden stop when the tractor suddenly stopped pulling; second, there was some unfairness to the competing contestants since the person assigned to step on to the sled could affect the outcome of the contest by how, where, and when he stepped on the sled; and third, there was unfairness to successive competitors when one or more of the step-on people were called away from the contest and replaced by a person of different weight. Mr. Watkins overheard two members of the County Fair Board discussing an unsuccessful attempt to rent a recently constructed hydraulic sled for use at the local county fair. Mr. Watkins immediately inquired if they be willing to rent a sled constructed by him for the county fair which was to be held the next week. They agreed and the Watkins' device was used in August, 1967. On August 14, 1967, it was taken to Bowling Green, Ohio, where it was displayed to a committee sponsoring a "1967 National Tractor pulling Championship" at the Wood County Fair Grounds in Bowling Green, Ohio. An application for patent was filed on April 24, 1968 and the drawings accompanying the patent application were substantially identical to the drawings prepared by the draftsman of the Bowling Green machine. Watkins later sued several individuals for infringement of his patent, most of which were immediately settled and applied license under his patent. He also sued NTPA for infringement and later offered license under his patent but NTPA did not respond to the charge or to the offer. On March 1, 1977, the rules and regulations of the United States Patent and Trademark Office were amended so as to allow a patentee to make an application for reexamination of his issued patent without alleging a belief Prior art Thorough conviction test Test of Obviousness Known to other

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that the patent was inoperative or invalid. In compliance thereto, Mr. Watkins filed an application for reissue under the newly promulgated modified practice which of course was opposed by NTPA on the ground that Watkins patent is invalid due to the existence of prior art. NTPA alleged that prior Watkins creation of the device, there were several other inventions of similar import and design, specifically the Shutzbaugh sled, the Harms hydraulic sled, the Grasscreek sled, and the Davidson horse-pulling sled patent. Patents Office ruled in favor of Watkins for failure of NTPA to prove the existence of prior art and hence the appeal. Issues: 1. W/N decision on patents office is valid. 2. W/N there existed a prior art. Held/Ratio: 1. YES. A patent shall be presumed valid. Each claim of a patent (whether independent or dependent form) shall be presumed valid independently of the validity of other claims; dependent claims shall be presumed valid even though dependent upon an invalid claim. The burden of establishing invalidity of a patent or any claim thereof shall rest on the party asserting it. The statutory presumption of validity can only be overcome by clear and convincing evidence. Where all of the prior art relied upon by the person alleging invalidity was considered by the Patent Office, the presumption of novelty and invention is greatly strengthened. The Patent Office decision must be accepted as controlling upon that question of fact in any subsequent suit between the same parties unless the contrary is established by testimony which in character and amount carries thorough conviction, meaning the less new evidence there is before the district court in a subsequent proceeding, the more blatant the factual errors of the Patent Office must be before the district court is justified in reversing the Patent Office decision. The court found that where the validity of a patent has been tested in a protested reissue proceeding in the United States Patent and Trademark Office, and where that Office has determined that the original patent was properly granted, this court will not find contrary to the findings of the Patent Office absent a thorough conviction supported by clear and convincing evidence that the Patent Office's decision was erroneous. 2. NO. The scope and content of the prior art are to be determined by the court. Differences between the prior art and the claims at issue are to be ascertained by the court and the level of ordinary skill in the pertinent art is to be resolved. Against this background, the obviousness or nonobviousness of the subject matter is determined. The test of obviousness is not whether a prior art device could be modified into something resembling the applicant's structure, but the proper test is whether, at the time the invention was made, it would have been obvious to a person of ordinary skill in the art, given the teachings of the prior art, to make the invention. In considering the prior art, prior patents are references only for what they clearly disclose or suggest and it is not proper to modify their structures in a manner which is not suggested by prior art. That which is alleged to be prior art must have its prior art existence and relevancy established by clear and convincing evidence. In order to qualify as prior art, the art must be art which was known before the invention by the patentee. Prior knowledge as must be prior public knowledge, that is, knowledge which is reasonably accessible to the public. The knowledge required involves some type of public disclosure and is not satisfied by knowledge of a single person, or a few persons working together. Further, in order for alleged prior inventions to qualify as prior art there must be proven, by clear and convincing evidence, complete conception of a buildable and operable device, diligence to a reduction to practice of the device, identification between the alleged prior art device and the claimed construction and lack of abandonment, and suppression or concealment by the claimed

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prior inventor. A party chargeable with proof of diligence in reducing conception to practice must account for the entire time period during which such diligence is required, that is from prior to the other party's conception to the alleged first party's reduction to practice. DISPOSITION: The court found that the NTPA has failed to prove complete conception by the Shutzbaugh group prior to Mr. Watkins reduction to practice nor has diligence been proven from the time of Mr. Watkins' conception to the construction of the Shutzbaugh sled. The court finds that claims 1 through 10 of the Watkins '590 patent are valid.

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Novelty Used by Others Rosaire v. Baroid Sales Division, National Lead Company (1955) Doctrines: An unsuccessful experiment which is later abandoned does not negate novelty in a new and successful device. Nevertheless, the existence of a machine abandoned after its completion and sufficient use to demonstrate its practicability, is evidence that the same ideas incorporated in a later development does not amount to invention Where a work is done openly, and in the ordinary course of activities of the employer, an affirmative act to bring the work to the attention of the public is NOT required.

Facts:

This is a case for patent infringement. Rosaire had patents relating to methods of prospecting for oil and hydrocarbons which worked under the assumption that gases have been created by the trapped hydrocarbons and that these gases have modified the surrounding rock. The methods claimed involved taking some samples of soil and treating them in a closed vessel, measuring the amount of hydrocarbon gas from each sample and correlating it with the location from which the samples were taken. This method was issued 2 patents, applied for by Rosaire in 1936. Rosaire alleged that Baroid began infringing in 1947 and that Rosaire asked Baroid to take a license but it was never agreed upon. Hence this suit seeking injunction and accounting. The trial court however held that the patents were invalid. The appellee had two arguments in support of the invalidation by the trial court. First was that there was some prior art which had anticipated the two Rosaire patents and second, that an invention is not patentable if it was "known or used by others in this country" before the patentee's invention thereof as per Section 102. The appellee alleged that a certain Teplitz Gulf Oil Corporation had already used the same inventions prior to the Rosaire patents. The appellant on the other hand, admitted that the Teplitz work preceded their own and that the Teplitz idea conceived the methods of the Rosaire patents, but continued on to say that Teplitz only applied for a patent in 1939 and that Teplitz' ideas were never published, hence the public was never apprised of the work. In assailing the decision of the trial court invalidating their patents, Rosaire also alleged that the work of Teplitz was an unsuccessful experiment which was later abandoned. Rosaire construed this to mean that the Teplitz experiment cannot affect the novelty of their own patents. Issues: 1. W/N the earlier experiment by Teplitz invalidated the patents in suit. a. W/N the Teplitz work was an "unsuccessful experiment"? b. W/N the lack of publication of Teplitz' work deprived an alleged infringer of the defense of prior use? Held/Ratio: 1. YES, the Teplitz work invalidated the Rosaire patents for the reasons stated below. a. NO, the teplitz work was not an unsuccessful experiment. The court agreed with Rosaire in that an unsuccessful experiment which is later abandoned does not negate novelty in a new and successful device. Nevertheless, the existence of a machine abandoned after its completion and sufficient use to demonstrate its practicability, is evidence that the same ideas incorporated in a later development does not amount to invention. The court stated that whether or not the Teplitz work was an unsuccessful experiment is a question of fact and on that point, the trial court found that the experiment was neither unsuccessful, nor abandoned. It had been used for a year by Teplitz but the experiment was suspended by Teplitz only to review the samples obtained by the method - not to review the effectivity of the method itself. The suspension was a result of two things the geographical area was unsuitable for the experiment, and in order to review the

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accumulated information already obtained. For this reason, the court affirmed the trial court's ruling invalidating the Rosaire patents. b. NO. The court found no reason to hold that where a work is done openly and in the ordinary course of the activities of the employer, an affirmative act to bring the work to the attention of the public is required. Hence, under the circumstances that attended the work of Teplitz, the fact of public knowledge need not even be shown to invalidate a subsequent patent.

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Novelty Printed Publication In re Klopfeinstein (August 18, 2004) Doctrines: Facts: On October 30, 2000, Carol KLOPFENSTEIN and John BRENT applied for a patent (Patent Application Serial No. 09/699,950 or "the '950 application") over methods of preparing foods comprising extruded soy cotyledon fiber ("SCF"). They assert that feeding mammals foods containing extruded SCF may help lower their serum cholesterol levels while raising HDL cholesterol levels. The fact that extrusion reduces cholesterol levels was already known by those of ordinary skill in the art that worked with SCF. What was not known at the time was that double extrusion increases this effect and yielded even stronger results. The Problem However, before their application, they made numerous disclosures of the subject matter of the 950 APPLICATION in numerous forums. October 1998 KLOPFEINSTEIN, BRENT, and their colleague LIU presented printed slide presentation (LIU Reference) entitled "Enhancement of Cholesterol-Lowering Activity of Dietary Fibers By Extrusion Processing" at a meeting of the American Association of Cereal Chemists ("AACC"). Such presentation disclosed every limitation of the invention disclosed in the 950 APPLICATION. o LIU Reference was displayed continuously for two and a half days at the AACC meeting November 1998 LIU Reference was put on display for less than a day at an Agriculture Experiment Station ("AES") at Kansas State University o Note: At neither presentation was there a disclaimer or notice to the intended audience prohibiting note-taking or copying of the presentation. However, the information was not catalogued or indexed. Public accessibility has been the criterion by which a prior art reference will be judged for the purposes of 102(b). Ultimately, this determination is on a case to case basis. The entire purpose of the "printed publication" bar was to "prevent withdrawal" of disclosures "already in the possession of the public" by the issuance of a patent.

On October 24, 2001, PTO examiner denied the 950 Application on the ground that the claim was anticipated by the LIU Reference, or obvious in view of the LIU and other References. KLOPFEINSTEIN et al. attempted to amend the 950 Application stating that the Liu Reference was not a "printed publication" because no copies were distributed and because there was no evidence that the reference was photographed. PTO was firm in its denial and issued a final order of denial on April 10, 2002. Hence, Klopfeinstein appealed to the Board. The Board, however, affirmed the PTO denial. Klopfeinstein et al. now appeal to the SC. The appellants argue on appeal that (1) The key to establishing whether or not a reference constitutes a "printed publication" lies in determining whether or not it had been disseminated by the distribution of reproductions or copies and/or indexed in a library or database. The LIU Reference was not a printed publication due to the lack of distribution and lack of evidence of its copying. (2) Because the Liu reference was not distributed and indexed, it cannot count as a "printed publication" for the purposes of 35 U.S.C. 102(b). Issues: 1. W/N the LIU Reference constitutes a printed publication for the purposes of 35 U.S.C. 102(b). ! YES

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2. W/N the 950 Application was properly rejected ! YES Held/Ratio: 1. YES. The LIU Reference is considered printed publication. Even if the cases cited by the appellants relied on inquiries into distribution and indexing to reach their holdings, they do not limit this court to finding something to be a "printed publication" only when there is distribution and/or indexing. Indeed, the key inquiry is whether or not a reference has been made "publicly accessible." The statutory phrase "printed publication" has been interpreted to mean that before the critical date the reference must have been sufficiently accessible to the public interested in the art; dissemination and public accessibility are the keys to the legal determination whether a prior art reference was "published." For instance, a public billboard targeted to those of ordinary skill in the art that describes all of the limitations of an invention and that is on display for the public for months may be neither "distributed" nor "indexed" but obviously counts as printed publication In MIT case, the Court did not even limit the future determinations of the applicability of the "printed publication" bar to instances in which copies of a reference were actually offered for distribution. It need not be offered for distribution per se. Even if in fact it was not distributed or viewed, it was held sufficient for the court's purposes that the records of the application were kept so that they could be accessible to the public. (Wyer case where the information was kept on a microfilm at the Australian Patent Office). Thus, throughout our case law, public accessibility has been the criterion by which a prior art reference will be judged for the purposes of 102(b). Oftentimes courts have found it helpful to rely on distribution and indexing as proxies for public accessibility. But when they have done so, it has not been to the exclusion of all other measures of public accessibility. In other words, distribution and indexing are not the only factors to be considered in a 102(b) "printed publication" inquiry. Ultimately, this determination is on a case to case basis. The factors relevant to the facts of this case are: the length of time the display was exhibited, the expertise of the target audience, the existence (or lack thereof) of reasonable expectations that the material displayed would not be copied, and the simplicity or ease with which the material displayed could have been copied. Upon reviewing the above factors, it becomes clear that the Liu reference was sufficiently publicly accessible to count as a "printed publication. The reference itself was shown for an extended period of time to members of the public having ordinary skill in the art of the invention behind the '950 patent application. Those members of the public were not precluded from taking notes or even photographs of the reference. And the reference itself was presented in such a way that copying of the information it contained would have been a relatively simple undertaking for those to whom it was exposed particularly given the amount of time they had to copy the information and the lack of any restrictions on their copying of the information. 2. YES. The 950 Application was properly denied. The ["printed publication"] bar is grounded on the principle that once an invention is in the public domain, it is no longer patentable by anyone.... Because there are many ways in which a reference may be disseminated to the interested public, "public accessibility" has been called the touchstone in determining whether a reference constitutes a "printed publication" bar under 35 U.S.C. 102(b). In this case, the appellants took no measures to protect the information they displayed nor did the professional norms under which they were displaying their information entitle them to a reasonable expectation that their display would not be copied. There was no disclaimer discouraging copying, and any viewer was free to take notes from the Liu reference or even to photograph it outright.

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According to the Wyer court, the entire purpose of the "printed publication" bar was to "prevent withdrawal" of disclosures "already in the possession of the public" by the issuance of a patent.

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Inventive Step - Subtests of Non -Obviousness KSR International Co. v. Teleflex, Inc. (2007) (adjustable pedal assembly with electronic throttle control) Doctrines: The Graham test is: Under 103, the scope and content of the prior art are to be determined; differences between the prior art and the claims at issue are to be ascertained; and the level of ordinary skill in the pertinent art resolved. Against this background the obviousness or nonobviousness of the subject matter is determined. Such secondary considerations as commercial success, long felt but unsolved needs, failure of others, etc., might be utilized to give light to the circumstances surrounding the origin of the subject matter sought to be patented. teaching, suggestion, or motivation test (TSM test), under which a patent claim is only proved obvious if some motivation or suggestion to combine the prior art teachings can be found in the prior art, the nature of the problem, or the knowledge of a person having ordinary skill in the art.

Facts: To control a conventional automobiles speed, the driver depresses or releases the gas pedal, which interacts with the throttle via a cable or other mechanical link. Because the pedals position in the footwell normally cannot be adjusted, a driver wishing to be closer or farther from it must either reposition himself in the seat or move the seat, both of which can be imperfect solutions for smaller drivers in cars with deep footwells. This prompted inventors to design and patent pedals that could be adjusted to change their locations. Teleflex (patent holder, and a competitor of KSR) sued KSR (a Canadian Supplier of auto parts, and chosen by General Motors Corporation to supply adjustable pedal systems for Chevrolet and GMC light trucks) for patent infringement. The patent at issue is entitled Adjustable Pedal Assembly With Electronic Throttle Control. The patentee is Steven J. Engelgau, and the patent is referred to as the Engelgau patent. Teleflex holds the exclusive license to the patent. Claim 4 of the Engelgau patent describes a mechanism for combining an electronic sensor with an adjustable automobile pedal so the pedals position can be transmitted to a computer that controls the throttle in the vehicles engine. When Teleflex accused KSR of infringing the Engelgau patent by adding an electronic sensor to one of KSRs previously designed pedals, KSR countered that claim 4 was invalid under the Patent Act, 35 U. S. C. 103, because its subject matter was obvious. Section 103 forbids issuance of a patent when the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. The District Court granted summary judgment in KSRs favor ruling that the Engelgau design was obvious using the Graham test1 and the TSM test.2 The Court of Appeals reversed, with principal reliance on the TSM test, ruling that the District Court had not been strict enough in applying the test. KSR challenges the TSM test in the manner of its application by the Court of appeals in this case. This case is KSRs application for certiorari before the Supreme Court of the United States. Issues:
1 The Graham v. Deere test is: Under 103, the scope and content of the prior art are to be determined; differences between the prior art and the claims at issue are to be ascertained; and the level of ordinary skill in the pertinent art resolved. Against this background the obviousness or nonobviousness of the subject matter is determined. Such secondary considerations as commercial success, long felt but unsolved needs, failure of others, etc., might be utilized to give light to the circumstances surrounding the origin of the subject matter sought to be patented.

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[Precedent decisions of the] Court of Appeals for the Federal Circuit has employed an approach referred to by the parties as the teaching, suggestion, or motivation test (TSM test), under which a patent claim is only proved obvious if some motivation or suggestion to combine the prior art teachings can be found in the prior art, the nature of the problem, or the knowledge of a person having ordinary skill in the art.

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1. W/N the Teleflexs Engelgau Patent was obvious. Held/Ratio: 1. YES. Supreme Court agrees with the District Court. For over a half century, the Court has held that a patent for a combination which only unites old elements with no change in their respective functions . . . obviously withdraws what is already known into the field of its monopoly and diminishes the resources available to skillful men.3 This is a principal reason for declining to allow patents for what is obvious. The first error of the Court of Appeals in this case was to foreclose this reasoning by holding that courts and patent examiners should look only to the problem the patentee was trying to solve. The Court of Appeals failed to recognize that the problem motivating the patentee may be only one of many addressed by the patents subject matter. The question is not whether the combination was obvious to the patentee but whether the combination was obvious to a person with ordinary skill in the art. Under the correct analysis, any need or problem known in the field of endeavor at the time of invention and addressed by the patent can provide a reason for combining the elements in the manner claimed. The second error of the Court of Appeals lay in its assumption that a person of ordinary skill attempting to solve a problem will be led only to those elements of prior art designed to solve the same problem. Ibid. The primary purpose of Asano was solving the constant ratio problem; so, the court concluded, an inventor considering how to put a sensor on an adjustable pedal would have no reason to consider putting it on the Asano pedal. Ibid. Common sense teaches, however, that familiar items may have obvious uses beyond their primary purposes, and in many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle. Regardless of Asanos primary purpose, the design provided an obvious example of an adjustable pedal with a fixed pivot point; and the prior art was replete with patents indicating that a fixed pivot point was an ideal mount for a sensor. The idea that a designer hoping to make an adjustable electronic pedal would ignore Asano because Asano was designed to solve the constant ratio problem makes little sense. A person of ordinary skill is also a person of ordinary creativity, not an automaton. There then existed a marketplace that created a strong incentive to convert mechanical pedals to electronic pedals, and the prior art taught a number of methods for achieving this advance. We see little difference between the teachings of Asano4 and Smith5 and the adjustable electronic pedal disclosed in claim 4 of the Engelgau patent. A person having ordinary skill in the art could have combined Asano with a pedal position sensor in a fashion encompassed by claim 4, and would have seen the benefits of doing so. [See this footnote6 for a summary of the prior art.] Nothing in the declarations proffered by Teleflex prevented the District Court from reaching the careful conclusions underlying its order for summary judgment in this case. KSR provided convincing evidence that mounting a modular sensor on a fixed pivot point of the Asano pedal was a design step well within the grasp of a person of ordinary skill in the relevant

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3 4

Great Atlantic & Pacific Tea Co. v. Supermarket Equipment Corp., 340 U. S. 147, 152 (1950).

The Asano Patent is a patent issued prior to the Engelgau Patent. The Asano patent reveals a support structure whereby, when the pedal location is adjusted, one of the pedals pivot points stays fixed. Asano is also designed so that the force necessary to depress the pedal is the same regardless of location adjustments.
5 The Smith Patent is a patent issued prior to the Engelgau Patent The Smith patent taught that to prevent the wires connecting the sensor to the computer from chafing and wearing out, the sensor should be put on a fixed part of the pedal assembly rather than in or on the pedals footpad. 6 The 936 patent taught the utility of putting the sensor on the pedal device, not in the engine. Smith, in turn, explained to put the sensor not on the pedals footpad but instead on its support structure. And from the known wire-chafing problems of Rixon, and Smiths teaching that the pedal assemblies must not precipitate any motion in the connecting wires, the designer would know to place the sensor on a nonmoving part of the pedal structure. The most obvious nonmoving point on the structure from which a sensor can easily detect the pedals position is a pivot point. The designer, accordingly, would follow Smith in mounting the sensor on a pivot, thereby designing an adjustable electronic pedal covered by claim 4.

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art. Its arguments, and the record, demonstrate that claim 4 of the Engelgau patent is obvious. In rejecting the District Courts rulings, the Court of Appeals analyzed the issue in a narrow, rigid manner inconsistent with 103 and our precedents. The judgment of the Court of Appeals is reversed, and the case remanded for further proceedings consistent with this opinion. [The following part of this digest is optional, but is instructive and illustrative.] Three cases decided after Graham illustrate the application of this [Graham] doctrine. In United States v. Adams, 383 U. S. 39, 40 (1966), a companion case to Graham, the Court considered the obviousness of a wet battery that varied from prior designs in two ways: It contained water, rather than the acids conventionally employed in storage batteries; and its electrodes were magnesium and cuprous chloride, rather than zinc and silver chloride. The Court recognized that when a patent claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable result. 383 U. S., at 5051. It nevertheless rejected the Governments claim that Adamss battery was obvious. The Court relied upon the corollary principle that when the prior art teaches away from combining certain known elements, discovery of a successful means of combining them is more likely to be nonobvious. Id., at 5152. When Adams designed his battery, the prior art warned that risks were involved in using the types of electrodes he employed. The fact that the elements worked together in an unexpected and fruit- ful manner supported the conclusion that Adamss design was not obvious to those skilled in the art. In Andersons-Black Rock, Inc. v. Pavement Salvage Co., 396 U. S. 57 (1969), the Court elaborated on this approach. The subject matter of the patent before the Court was a device combining two pre-existing elements: a radiant- heat burner and a paving machine. The device, the Court concluded, did not create some new synergy: The radiant- heat burner functioned just as a burner was expected to function; and the paving machine did the same. The two in combination did no more than they would in separate, sequential operation. Id., at 6062. In those circum- stances, while the combination of old elements performed a useful function, it added nothing to the nature and quality of the radiant-heat burner already patented, and the patent failed under 103. Finally, in Sakraida v. AG Pro, Inc., 425 U. S. 273 (1976), the Court derived from the precedents the conclu- sion that when a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious. The principles underlying these cases are instructive when the question is whether a patent claiming the combination of elements of prior art is obvious. When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one. If a person of ordinary skill can implement a predictable variation, 103 likely bars its patentability. For the same reason, if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the tech- nique is obvious unless its actual application is beyond his or her skill. Sakraida and AndersonsBlack Rock are illustrativea court must ask whether the improvement is more than the predictable use of prior art elements according to their established functions.

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Inventive Step - Subtests of Non-Obviousness In Re: Marek Z. Kubin And Raymond G. Goodwin (2009) Doctrines: Facts: IN RE MAREK Z. KUBIN and RAYMOND G. GOODWIN Appeal from the United States Patent and Trademark Office, Board of Patent Appeals and Interferences. RADER, Circuit Judge. Marek Kubin and Raymond Goodwin (appellants) appeal from a decision of the Board of Patent Appeals and Interferences (the Board) rejecting the application as obvious and invalid 1 for lack of written description. This court affirms. Appellants Marek Kubin and Raymond Goodwin filed U.S. Patent Application (the "Application"), which claimed the DNA sequence encoding the protein known as Natural Killer Cell Activation Inducing Ligand ("NAIL"). o o Natural Killer ("NK") cells are a class of cytotoxic lymphocytes that have a major role in fighting tumors and viruses. NAIL is a specific type of receptor protein on the surface of the NK cells that, when stimulated, activates cytotoxic mechanisms. This case presents a claim to a classic biotechnology invention the isolation and sequencing of a human gene that encodes a particular domain of a protein. (polynucleotides) encoding a protein (polypeptide) known as the Natural Killer Cell Activation Inducing Ligand (NAIL). Natural Killer (NK) cells, thought to originate in the bone marrow, are a class of cytotoxic lymphocytes that play a major role in fighting tumors and viruses.

In their specification, appellants disclosed the amino acid sequence of NAIL and its isolated DNA sequence. o o Appellants also described the alleged discovery of a binding relationship between NAIL and a protein known as CD48. The NAIL-CD48 binding interaction increased cell cytotoxicity and the production of interferon, thereby enhancing the effectiveness of NK cells. Specifically, it claimed a genus of DNA sequences encoding a protein that binds to CD48 and was at least 80% identical to the CD48 binding region of NAIL. Appellants only disclosed two DNA sequences falling with the scope of the claimed genus: the coding sequence of NAIL and the full NAIL gene which includes non-coding sequences. In addition, the specification contemplated variants of NAIL that retained the same binding properties, but did not indicate any actual example variants of NAIL.

Claim 73 of the application claimed the DNA encoding the CD48-binding region of NAIL. o o

The Board of Patent Appeals and Interferences (the "Board") rejected the application claims as obvious under 35 U.S.C. 103(a) and invalid under 35 U.S.C. 112 for lack of written description. In finding the claims invalid under Section 112, the Board found that although appellants disclosed two sequences falling within the scope of claim 73, not enough sequences were disclosed to establish possession of the claimed genus. A given amino acid may be replaced, for example, by a residue having similar physiochemical characteristics. Examples of such conservative substitutions include substitution of one aliphatic residue for another.

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However, the specification does not indicate any example variants of NAIL that make these conservative amino acid substitutions. They have not described what domains of those sequences are correlated with the required binding to CD48, and thus have not described which of NAILs amino acids can be varied and still maintain binding. Without a correlation between structure and function, the claim does little more than define the claimed invention by function. That is not sufficient to satisfy the written description requirement.

The Board found appellants' claims obvious in light of the combined teachings of U.S. Patent No. 5,688,690 ("Valiante") and Joseph Sambrook et al., Molecular Cloning: A Laboratory Manual 43-84 (2d ed.1989) ("Sambrook"). Valiante disclosed the receptor "p38" that was found on human NK cells and served as an activation marker for cytotoxic cells. Valiante also disclosed a monoclonal antibody that bound specifically to p38 which could be used as a probe for specifically identifying and targeting p38. The Board found that p38 was the same protein as NAIL. o Thus, Valiante taught that the DNA and protein sequences for the receptor p38 could be obtained by conventional methodologies known to one of skill in the art. o Valiante also incorporated Sambrook by reference, which discussed methods for molecular cloning, including detailed information on cloning materials and techniques. The Board also considered Porunelloor Mathew et al., Cloning and Characterization of the 2B4 Gene Encoding a Molecule Associated with Non-MHC-Restricted Killing Mediated by Activated Natural Killer Cells and T Cells, 151 J. Immunology 5328-37 (1993) ("Mathew"), o o o It was cumulative to Valiante and Sambrook. Mathew disclosed a cell surface receptor protein called 2B4 that was expressed in all NK cells. It disclosed that 2B4 had a part in activating mouse NK cells and taught chromosomal mapping, cloning, expression, and molecular characterization of the gene. It also described a monoclonal antibody specific to 2B4 and a detailed cloning protocol for obtaining the gene coding sequence for the 2B4 protein.

Because of NAIL's significance, a person of ordinary skill in the art would have recognized the value of isolating the NAIL DNA coding sequence ("cDNA") and would have applied conventional methodologies to isolate it. o appellants' application was not one of innovation but of ordinary skill and common sense and would have been obvious to isolate the NAIL cDNA.

Issues: 1. Was Board's finding of obviousness under Section 103 proper? 2. Did the Board properly apply the "obvious to try" doctrine in finding that it was obvious to isolate the cDNA of NAIL? Held/Ratio: Held: The Federal Circuit affirmed the decision of the Board and found the application invalid for obviousness. In light of the Board's finding that Valiante's p38 was the same protein as NAIL, Valiante's teaching to obtain the cDNA of p38 necessarily taught one to obtain the cDNA of NAIL that binds to CD48. The Federal Circuit also found that appellants' application was anticipated by Valiante and Sambrook. In addressing the issue of "obvious to try," the court found that obviousness only requires a reasonable expectation of success from previous teachings. The Federal Circuit agreed with the

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Board's decision that in light of Valiante and Sambrook it was obvious to isolate the cDNA of NAIL. Ratio: An obviousness analysis must rely on four factual inquiries: (1) the scope and content of the prior art; (2) the differences between the prior art and the claims at issue; (3) the level of ordinary skill in the pertinent art; and (4) objective evidence of nonobviousness. With regard to the anticipation of appellants' application by Valiante and Sambrook, the court found that the methodology in isolating NAIL DNA was essentially the same. o o o Appellants claimed that Valiante and Sambrook did not give any guidance for the preparation of a source of mRNA for the preparation of cDNA. However, the court noted that focusing on differences was only material if appellants were claiming a method. In the instant case appellants only claimed the gene sequence. The obviousness inquiry should evaluate whether the claimed sequence, and not the unclaimed cloning technique, is obvious in light of the abundant prior art. Regardless, the appellants' argument was contradicted by their disclosure in their application of the use of "standard biochemical methods (such as those outlined in Sambrook. . .)." The teachings of a prior art reference are underlying factual questions in the obviousness inquiry.

The court then addressed the Board's use of Mathew as prior art cumulative to Sambrook and Valiante. Mathew showed how a person skilled in the art could use routine skill in cloning and sequencing a similar gene. A researcher of ordinary skill in the art would have recognized that Mathew and Valiante both focused on the regulation of NK cells-Mathew in mice and Valiante in humans. Although Mathew contained data suggesting that the gene was not expressed in humans, the court concluded that this would not have dissuaded a person skilled in the art from combining Mathew with Valiante in order to isolate the gene coding sequence. The court also found that there was no obligation for the Board to predicate its obviousness finding on factual findings regarding a prior teaching of NAIL's binding to the CD48 protein. o The application itself stated that the CD48 binding was not an additional requirement imposed by the NAIL protein claims, but rather a property necessarily present in NAIL. Because Valiante's p38 was the same protein as NAIL, Valiante's teaching of obtaining cDNA from p38 must have taught one to obtain the cDNA of NAIL that exhibits the CD48 binding property. In KSR the Supreme Court stated that if market pressure or design need was present and there were a finite number of identified, predictable solutions, a person skilled in the art had good reason to pursue the known options in his technical grasp. If this led to the anticipated success, then it is likely that the product was not of innovation but of ordinary skill and common sense. The Supreme Court held that in this situation, the fact that a combination was obvious to try might give rise to obviousness under Section 103. The first was where obvious to try was to vary all parameters and try each of them. The second erroneous use was where obvious to try was to explore a new technology or general approach where prior art only gave general guidance as to the particular form of the claimed invention or how to achieve it.

issue of obviousness based on the "obvious to try" doctrine. o

Two classes in which "obvious to try" was erroneously equated to obviousness. o o

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In O'Farrell the Federal Circuit observed that obviousness was found where the prior art contained detailed enabling methodology and evidence suggesting it would be successful. Obviousness did not require absolute predictability of success, only a reasonable expectation of success. Because Valiante disclosed the same protein as the Application, and they both cited to the Sambrook cloning manual, one of ordinary skill in the art would have been motivated to isolate the NAIL cDNA. The prior art taught a protein of interest, a motivation to isolate that protein, and instructions to use a monoclonal antibody specific to the protein for the cloning of the gene. Therefore, a person skilled in the art would have had a resoundingly reasonable expectation of success. As the Board found, the prior art here provides a reasonable expectation of success, for obviousness under 103 is all that is required. Thus, this court affirms the Boards conclusion as to obviousness. The court also declined to limit KSR to the predictable arts, as opposed to the "unpredictable art" of biotechnology. The court stated that a person skilled in the art would have found the claimed results of this case profoundly predictable in this "unpredictable" art. Although Valiante did not supply the amino acid or DNA sequences for NAIL, the court held that the prior art gave a reasonable expectation of success for obtaining a DNA sequence within the scope of claim 73, which was enough for a finding of obviousness under Section 103.

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Inventive Step Scope and Content of Prior Art In re Winslow (1966) Doctrine: In performing the obviousness analysis, courts should picture the inventor as working in his shop with the prior art references, which he is presumed to know, hanging on the walls around him. Requirement of non-obviousness require courts to presume full knowledge by inventor of prior art in the field of his endeavor. Claims 1 and 3, and 1118, in patent application relating to an apparatus for opening and filling flexible plastic bags by supplying jet of air to uppermost bag of stack of bags to open it to permit insertion of article were not patentable over prior art for obviousness to one skilled in art. Winslows machine was obvious, based on the 3 patents for similar devices. Winslows combination of features was an obvious step in light of the prior art.

Facts:

Winslow filed a patent application for Apparatus for and Method of Opening, Filling and Closing Thermoplastic Bags. It relates to an apparatus for opening and filling flexible plastic bags by supplying jet of air to uppermost bag of a stack of bags to open it to permit insertion of article. The Examiner rejected claims 1 and 3, and claims 11-18. The Board of Appeals affirmed. Winslow appealed. The invention is an apparatus for packaging articles within flexible plastic bags by supplying a jet of air to the uppermost bag of a stack of bags to open it to permit the insertion of the article. The bags are generally rectangular and have an opening at one end. One of the *1575 walls is provided with an extension, or flap, which projects beyond the mouth and which contains a plurality of transversely aligned holes. Perforations extending from each hole to the edge of the flap weaken it so it can be torn from retaining pins. The bags are stacked, with their flap sides down, and placed on a horizontal support state supported at one end on a spring-biased hinge. The plate is depressed when loaded with bags, pivoting on its hinge. Upon release, the spring urges the support upwardly toward an upper plate member having pins depending therefrom which pass through the holes in the bag flaps and into openings provided in the lower support plate. Only the flap of each bag underlies the upper plate member, which functions as a stop against unlimited upward movement of the stack of bags and which, **1018 in conjunction with the lower support, acts to clamp or sandwich the flaps of the bags, the pins passing through the flap holes. The uppermost bag is opened by directing an air blast across the top plate member and into the mouth thereof. An article is then inserted, either automatically or manually, through the mouth which is kept open by continuing the blast. The bag is then pulled longitudinally in a direction parallel to and away from the air blast, thereby tearing the flap along the perforated lines and removing the filled bag from the pin. The bag is then closed and heat sealed. All the claims define an apparatus for opening and filling bags, there being no provision for closing or sealing the bags once filled. Claims 1 and 3 require but one depending pin. Remaining claims 11-18 are patterned after certain claims in a patent to one Altman but was not relied on by the Patent Office in rejecting the application. The examiner rejected the claims as unpatentable over Gerbe, Hellman, and Rhoades. Gerbe discloses a bagging and filling machine employing a stack of bags, a bag support, plate member and an air blast source. The stack is aligned by the enclosure around the 3 closed sides of the bags, and the plate member clamps the bags at the open end. Hellman discloses an apparatus for filling envelopes or bags with piston rings after first opening them by means of an air blast. The bags are held vertically on a rod which passes through a hold in each flap and which terminates in a recessed portion of an opposing plate member 5. The bag nearest the opposing plate 5 is opened by an air jet after which a piston ring drops from above, tearing the bag free from the support rod by ripping the flap, causing the bag to fall into a hopper. The bag is then sealed.

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Rhoades discloses an apparatus for suspending a stack of paper bags in a vertical position, employing a piercing point which pierces the open end portions of some of the bags as they approach the position from which they are removed. Issue: 1. W/N Winslows patent application should be granted. Held/Ratio: 1. No. Gerbes patent discloses a bagging and filling machine of the same character as that disclosed by Winslow. The only difference is the means employed to hold a stack of bags. It (Gerbes) opened bags with an air-blast mechanism, though that machine did not hold bags by means of rods. Gerbe relies on the clamping action and a stop member for holding the bags. On the other hand, Winslow employs pins which pass through openings in the stack of bags. Hellmans patent showed the use of a pin for holding bags while the outermost bag is being opened by an air blast which is related to Gerbes apparatus. While the patent to Rhoades does not disclose the use of an air blast, it does disclose the use of a clamping pin for maintaining a plurality of bags in position while the uppermost bag is being opened and removed. In other words, Rhoades patent disclosed a machine that held bags using rods, though the bags were hung vertically in the machine. The patents to Hellman and Rhoades would render obvious to one skilled in the art a modification of the Gerbe apparatus wherein pins would be provided passing through openings in the bag flaps. The principal difference between what is claimed and the prior art resides in the at least one depending pin of claims 1 and 3 and the pin means' as described in the other claims, which are so worded as apparently to require at least two pins, as the bags have two holes through all of which the pin means' extend. o Hellmans is in the same art and has pins means, but he calls it a rod. It extends through the holes in the bag flaps to hold them against the air blast which opens them. There is no patentable distinction between a rod and a pin. o The pins in Winslows machine and the rod in Hellman perform the very same function bag holding during air blast. o The change from a vertical to a horizontal position of the bags is immaterial. The proper way to apply the 103 obviousness test to a case like this is to first picture the inventor as working in his shop with the prior art references which he is presumed to know hanging on the walls around him. One then notes that what applicant Winslow built here he admits is basically a Gerbe bag holder having air-blast bag opening to which he has added two bag retaining pins. If there were any bag holding problem in the Gerbe machine when plastic bags were used, their flaps being gripped only by spring pressure between the top and bottom plates, Winslow would have said to himself, Now what can I do to hold them more securely? Looking around the walls, he would see Hellman's envelopes with holes in their flaps hung on a rod. He would then say to himself, Ha. I can punch holes in my bags and put a little rod (pin) through the holes. That will hold them. After filling the bags, I'll pull them off the pins as does Hellman. Scoring the flap should make tearing easier. Thus does appellant make his claimed invention merely by applying knowledge clearly present in the prior art. Section 103 requires us to presume full knowledge by the inventor of the prior art in the field of his endeavor.

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Scope and Content of Prior Art Hazeltine Research, Inc., Et Al. V. Brenner, Commissioner Of Patents (1965)
Doctrines: Fact that invention sought to be patented was not precisely the same as that contained in other pending patent application was without significance in determining whether such other pending application constituted prior art available as bar to patentability. Application for patent pending in patent office at time that second application was filed constituted part of prior art and was available as bar to second patent application.

Facts:

Petitioner Robert Regis filed an application for a patent on a new and useful improvement on a microwave switch in 1957. The application was denied in 1959 on the ground that the invention was not one which was new or unobvious in light of the prior art, thus did not meet the standards set forth in 35 U.S.C. 103 . The Examiner said that the invention was unpatentable because of the joint effect of the disclosures made by patents previously issued to Carlson, and to Wallace. The Carlson patent was issued in 1949 (over 8 yrs prior to Regis filling) and that patent is admittedly a part of the prior art insofar as Regis' invention is concerned. The Wallace patent, however, was pending in the Patent Office (since 1954, 3 yrs and 9 mos before Regis filed his application) when the Regis application was filed and was issued in 1958 (43 days after Regis application). An appeal to the Patent Office Board of Appeals was filed alleging that the Wallace patent could not be properly considered a part of the prior art because it had been a "co-pending patent" and its disclosures were secret and not known to the public. The Board of Appeals rejected this argument and affirmed the decision of the Patent Examiner. Regis and Hazeltine, which had an interest as assignee, then instituted the present action in the District Court pursuant to 35 U. S. C. 145 to compel the Commissioner to issue the patent. The District Court agreed with the Patent Office that the co-pending Wallace application was a part of the prior art and directed that the complaint be dismissed. On appeal the Court of Appeals affirmed per curiam. And now, this court is hearing the case on certiorari. Issues: 3. W/N co-pending application is included in the prior art. Held/Ratio: 3. YES. The Wallace patent application is considered a prior art. The petitioners contend that the term prior art as used in 103, really means only art previously publicly known, stating it could be seen in the legislative history that prior art means "what was known before as described in section 102" thus indicating that the Congress intended prior art to include only inventions or discoveries which were already publicly known at the time an invention was made. The Commissioner, relying chiefly on Alexander Milburn Co. v. Davis-Bournonville Co., however contends that when a patent is issued, the disclosures contained in the patent become a part of the prior art as of the time the application was filed, not, as petitioners contend, at the time the patent is issued. In Milburn, a patent was held invalid because, at the time it was applied for, there was already pending an application which completely and adequately described the invention. In holding that the issuance of a patent based on the first application barred the valid issuance of a patent based on the second application, Mr. Justice Holmes, speaking for the Court, said, "The delays of the patent office ought not to cut down the effect of what has been done. . . . [The first applicant] had taken steps that would make it public as soon as the Patent Office did its work, although, of course, amendments might be required of him before the end could be reached. We see no reason in the words or policy of the law for allowing [the second applicant] to profit by the delay. It should also be noted that in the revision of the patent laws in 1952, Congress showed its approval of the holding in Milburn by adopting 35 U. S. C. 102 (e) which provides that a person shall be entitled to a patent unless "(e) the invention was described in a patent granted on an application for patent by another filed in the United States before the invention

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thereof by the applicant for patent." Petitioners tried to contend that Milburn (and corollarily 102(e) since it was Milburn that gave rise to the provision) should not be applied in this case because what was involved there was the co-pending applications described the same identical invention. But here, the Regis invention is not precisely the same as that contained in the Wallace patent, but is only made obvious by the Wallace patent in light of the Carlson patent. Nevertheless, this court agrees with the Commissioner that the alleged distinction is without significance since it provides no reason to depart from Milburn and that the reasoning applies equally in the present case. When Wallace filed his application, he had done what he could to add his disclosures to the prior art. The rest was up to the Patent Office. Had the Patent Office acted faster, had it issued Wallace's patent two months earlier, there would have been no question here. To adopt the result contended for by petitioners would create an area where patents are awarded for unpatentable advances in the art. There is no reason to read into 103 a restricted definition of "prior art" which would lower standards of patentability to such an extent that there might exist two patents where the Congress has plainly directed that there should be only one.&

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Inventive Step Non-Analogous Arts Limitation In re Clay (1992) Doctrines: Two criteria has been used to determine whether prior art is analogous: (1) whether the art is from the same field of endeavor, regardless of the problem addressed, and (2) if the reference is not within the field of the inventor's endeavor, whether the reference still is reasonably pertinent to the particular problem with which the inventor is involved. Only a prior art in an analogous field of work may support a finding of obviousness

Facts:

Clay's invention is a process for storing refined liquid hydrocarbon product in a storage tank having a dead volume between the tank bottom and its outlet port. It involves a gelation solution, which gels, after it is placed in the tanks dead volume. The claims on appeal are claims 1, 8 and 11. 7 The examiner rejected it for obviousness due to two prior art references- U.S. Patent 4,664,294 (Hetherington), which disclose an apparatus for displacing dead space liquid using impervious bladders, or large bags, formed with flexible membranes; and U.S. Patent 4,683,949 (Sydansk) which is a process for reducing the permeability of hydrocarbon-bearing formations and thus improving oil production, using a gel similar to that in Clay's invention. Board findings: agreed with the examiner that, although neither reference alone describes Clay's invention, Hetherington and Sydansk combined support a conclusion of obviousness because it was a solution to that problem generally involved in filling the dead space with something. The Board combined the two prior art references, finding that the "cavities" filled by Sydansk are sufficiently similar to the "volume or void space" being filled by Hetherington for one of ordinary skill to have recognized the applicability of the gel to Hetherington. Issue: 1. W/N Clays invention is non-patentable for obviousness Held/ Ratio: 1. NO, the invention is patentable. A prerequisite to making this finding is determining what is "prior art," in order to consider whether "the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art. According to Clay, the claims were improperly rejected because Sydansk is a nonanalogous art. Two criteria has been used to determine whether prior art is analogous: (1) whether the art is from the same field of endeavor, regardless of the problem addressed, and (2) if the reference is not within the field of the inventor's endeavor, whether the reference still is reasonably pertinent to the particular problem with which the inventor is involved.

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7

Claims 1, 8, and 11 are illustrative of the claims on appeal:

1. A process for storing a refined liquid hydrocarbon product in a storage tank having a dead volume between the bottom of said tank and an outlet port in said tank, said process comprising: preparing a gelation solution comprising an aqueous liquid solvent, an acrylamide polymer and a crosslinking agent containing a polyvalent metal cation selected from the group consisting of aluminum, chromium and mixtures thereof, said gelation solution capable of forming a rigid crosslinked polymer gel which is substantially insoluble and inert in said refined liquid hydrocarbon product; placing said solution in said dead volume; gelling said solution substantially to completion in said dead volume to produce said rigid gel which substantially fills said dead volume; and storing said refined liquid hydrocarbon product in said storage tank in contact with said gel without substantially contaminating said product with said gel and without substantially degrading said gel.

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Using the first criteria: Sydansk cannot be considered to be within Clay's field of endeavor merely because both relate to the petroleum industry. Sydansk teaches the use of a gel in unconfined and irregular volumes within generally underground natural oil-bearing formations to channel flow in a desired direction; Clay teaches the introduction of gel to the confined dead volume of a man-made storage tank. The Sydansk process operates in extreme conditions, with petroleum formation temperatures as high as 115C and at significant well bore pressures; Clay's process apparently operates at ambient temperature and atmospheric pressure. Clay's field of endeavor is the storage of refined liquid hydrocarbons. The field of endeavor of Sydansk's invention, on the other hand, is the extraction of crude petroleum. Using the second criteria: The reference is not reasonably pertinent to the problem. Sydansk's gel treatment of underground formations functions to fill anomalies8 so as to improve flow and production of fluids, while Clay's gel functions to displace liquid product from the dead volume of a storage tank. Sydansk is concerned with plugging formation anomalies so that fluid is subsequently diverted by the gel into the formation matrix, thereby forcing bypassed oil contained in the matrix toward a production well. Sydansk is faced with the problem of recovering oil from rock, i.e., from a matrix which is porous, permeable sedimentary rock of a subterranean formation where water has channeled through formation anomalies and bypassed oil present in the matrix. Such a problem is not reasonably pertinent to the particular problem with which Clay was involved--preventing loss of stored product to tank dead volume while preventing contamination of such product. Decision of Board is reversed. Since Sydansk is non-analogous art, the rejection is improper.

8 a volume or void space in the formation having very high permeability relative to the matrix [the other region type, consisting of homogeneous porous rock]."

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Non-obviousness in Chemistry In Re Papesch (1963) (compound, anti-inflammatory, unobviousness) Doctrines: Facts: This case is about the the rejection of claims 1-3 of Viktor Papeschs application for 2,4,6TRIALKYLPYRAZOLO (4,3-d)-4,5,6,7-TETRAHYDROPYRIMIDINE-5,7-DIONES. The specification in the application states that these compounds are: have been found to possess unexpectedly potent anti-inflammatory activity in contrast to the related trimethyl compound. The instant compounds are also diuretic agents. From standpoint of patent law, compound and all of its properties are inseparable. A formula is not a compound, and though the formula may serve to identify what is being patented, the thing which is patented is not formula but the compound identified by it. Unobviousness - unexpected properties could show that a claimed compound that appeared to be obvious on strucutural grounds was in fact not obvious when looked at as a whole.

According to the Examiner, Claims 1-3 are rejected as being unpatentable over Robins et al. Note Compound XVI. The ethyl and n-butyl side chains depicted in applicant's claims 2 and 3 are obvious homologs of the methyl groups shown in identical positions in the reference compound and the method of preparation is substantially the same. Compound XVI of the Robins et al. article is described by its structural formula which would be identical with that of appellant's claim 1, if all of the three R's therein were methyl, -CH(3), producing a trimethyl compound. But Papesch claims that what the Patent Office relies on as prior art to show obviousness of the claimed compounds is the formula considered least likely by the authors. He also filed an affidavit of Dr. Francis J. Saunders a physiologist and a member of the Biology Division of G. D. Searle & Co., --owner of the application at bar. The affidavit reports that comparative tests of the Robins et al. trimethyl compound and appellant's triethyl compound show that the latter is an active anti-inflammatory agent while the prior art compound is completely inactive in that respect. Even with the affidavit of Dr. Saunders, the Examiner still rejected the claimed compounds since they were obvious. The affidavit is interesting but irrelevant to the rejection since it is not directed to the subject matter sought to be patented, namely, the use in the arts of the compounds. The obvious compound is not made less obvious by its properties in an art use. It appears that if an invention is present, it resides in the use of the claimed compounds as anti-inflammatory agents and should be claimed as such. Papesch appealed to the Patent Board. It held that the requirement of obviousness is no different in chemical cases than with respect to other categories of patentable inventions. From the viewpoint of the organic chemist, the structures of the claimed compounds would be obvious' from the Robins et al.

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reference disclosure of the related trimethyl compound as well as from the disclosure of methylation by conventional methods, which would suggest to a chemist the use of ethylating or other alkylating agent of short chain length as a possibility. Papesch only relied on a pharmacological property as the significant characteristic but the unobviousness required of a claimed chemical compound to make it patentable must be considered from a chemical viewpoint, i.e., from the viewpoint of chemists rather than pharmacologists, inasmuch as it is the chemists who are involved with the synthesis of new compounds, and in their identification by physical characteristics and by reactions with other agents. Since the compounds are obvious to the chemist from the disclosure in Robins et. al, the compound cannot be patented. Issues: 1. W/N the compound may be patented. Held/Ratio: 1. YES. The decision of the Patent Board is reversed. In the case, the Patent Office failed to take into consideration the biological or pharmaceutical property of the compounds as anti-inflammatory agents on the ground that to chemists the structure of the compounds would be so obvious as to be beyond doubt, and that a showing of such properties is to be used only to resolve doubt. But from the standpoint of patent law, a compound and all of its properties are inseparable; they are one and the same thing. The graphic formula, the chemical nomenclature, the systems of classification and study such as the concepts of homology, isomerism, etc., are mere symbols by which compounds can be identified, classified, and compared. But a formula is not a compound and while it may serve in a claim to identify what is being patented (like the metes and bounds of a deed identifying a plot of land), the thing that is patented is not the formula but the compound identified by it. The patentability of the thing does not depend on the similarity of its formula to that of another compound but of the similarity of the former compound to the latter. There is no basis in law for ignoring any property in making such a comparison. An assumed similarity based on a comparison of formula must give way to evidence that the assumption is erroneous. The argument has been made that patentability is here being asserted only on the basis of one property, the anti-inflammatory activity, and that the compounds claimed and the compound of the prior art presumably have many properties in common. Presumably they do, but presumption is all we have here. Prior art disclosure was not merely of a structurally similar compound but also, at least to a degree, of the same desired property relied on for patentability in the new compound. Such an other factor must of course be considered because it bears on the obviousness of the compound, which is, realistically and legally, a composite of both structure and properties. Notes: (Just in case, you dont understand all this shiz) Hass-Henze doctrine: Proof of the existence of unobvious or unexpected beneficial properties in a new compound, which would otherwise appear to be obvious (along with its properties), is indicative of the presence of invention and hence of patentability Homolog - compound belonging to a series of compounds differing from each other by a repeating unit. On unobviousness: *Initially, the courts based non-obviousness analysis wholly on the structural similiarities between prior art compunds and the claimed compounds. Over time, courts recognized that unexpected properties could show that a claimed compound that appeared to be obvious on strucutural grounds was in fact not obvious when looked at as a whole.9 Such is the

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case of In Re Papesch. When the Patent Office rejected Papeschs claim on the ground of obviousness, it failed to consider the unobviousness of the compound that while it may seem the same to chemists, its not the same for patent law because the compound has antiinflammatory properties which the prior art does not have.

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Non-obviousness in Chemistry In re: Baird (1994) (Flash Fusible Toner Obviousness Case) Doctrines: Facts: Baird et al. applied for a patent over a flash fusible toner10 comprising compound A and compound B.11 The claim was rejected by the U.S. Patent and Trademark Office (PTO) Board on the ground of obviousness.12 PTO reasoned that since another patentthe Knapp Formulacontained a broad range of variables and encompassed a large number of different compounds, one of which was compound A, then compound A was obvious under said formula. The examiner reasoned that [compound A] may be easily derived from the generic formula of the [compound] in [Knapp] and all the motivation the worker of ordinary skill in the art needs to arrive at the particular polyester of the instant claim is to follow [that formula]. Baird, on the other hand, argued that there was no motivation for one to select compound A from Knapp. Issues: 1. W/N the claimed compounds would have been obvious to one of ordinary skill in the art. Held/Ratio: 1. NO. A disclosure of millions of compounds does not render obvious a claim to three compounds, particularly when that disclosure indicates a preference leading away from the claimed compounds. Baird does not dispute the fact that the generic diphenol formula of Knapp encompasses compound A. Rather, Baird argues that there is no suggestion in Knapp to select compound A from the vast number of diphenols covered by the generic formula and that the Board thus erred in concluding that the claimed compounds would have been obvious. In the instant case, the generic diphenol formula disclosed in Knapp contains a large number of variables, and we estimate that it encompasses more than 100 million different diphenols, only one of which is compound A. While the Knapp formula unquestionably encompasses compound A when specific variables are chosen, there is nothing in the disclosure of Knapp suggesting that one should select such variables. The fact that a claimed compound may be encompassed by a disclosed generic formula does not by itself render that compound obvious.

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10 11 12

Basically a better kind of toner used in photocopying machines. Compound A: a polyester of bisphenol A; Compound B: an aliphatic dicarboxylic acid.

35 USC 103: A patent for a claimed invention may not be obtained xxxx if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. (emphasis supplied)

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Non Obviousness in Biotechnology

In Re: Deuel (1995) (cdna isolation)

Doctrines: A prima facie case of unpatentability requires that the teachings of the prior art suggest the claimed compounds to a person of ordinary skill in the art. Normally a prima facie case of obviousness is based upon structural similarity, i.e., an established structural relationship between a prior art compound and the claimed compound.

Facts: The claimed inventionof Deuel relates to isolated and purified DNA and cDNA molecules encoding heparin-binding growth factors ("HBGFs"). 1 HBGFs are proteins that stimulate mitogenic activity (cell division) and thus facilitate the repair or replacement of damaged or diseased tissue. Messenger ribonucleic acid ("mRNA") is a similar molecule that is made or transcribed from DNA as part of the process of protein synthesis. Complementary DNA ("cDNA") is a complementary copy ("clone") of mRNA, made in the laboratory by reverse transcription of mRNA. Like mRNA, cDNA contains only the protein-encoding regions of DNA. Thus, once a cDNA's nucleotide sequence is known, the amino acid sequence of the protein for which it codes may be predicted using the genetic code relationship between codons and amino acids. The reverse is not true, however, due to the degeneracy of the code. Many other DNAs may code for a particular protein. Due to the nature of genetic discovery, Deuel did not disclose the structure of or how to obtain more than two cDNA molecules, even though the claims encompass many more molecules than those disclosed. The patent examiner rejected the claims as obvious under 35 U.S.C. 103, which was affirmed by the Board of Patent Appeals and Interferences (BPAI). The BPAI noted that, because cloning is well known in the art, once a protein is placed in the public domain, the gene that codes for that protein is also inherently in the public domain. Deuel appealed. Issues: 1. W/N the what the Deuel discovered was already obvious when Bohlen made his HGBF cloning Held/Ratio: 1. NO. Deuel argues that the Board failed to follow the proper legal standard in determining that the claimed cDNA molecules would have been prima facie obvious despite the lack of structurally similar compounds in the prior art. Deuel argues that the Board has not cited a reference teaching cDNA molecules, but instead has improperly rejected the claims based on the alleged obviousness of a method of making the molecules. We agree. Because Deuel claims new chemical entities in structural terms, a prima facie case of unpatentability requires that the teachings of the prior art suggest the claimed compounds to a person of ordinary skill in the art. Normally a prima facie case of obviousness is based upon structural similarity, i.e., an established structural relationship between a prior art compound and the claimed compound. Structural relationships may provide the requisite motivation or suggestion to modify known compounds to obtain new compounds. For example, a prior art compound may suggest its homologs because homologs often have similar properties and therefore chemists of ordinary skill would ordinarily contemplate making them to try to obtain compounds with improved properties. Similarly, a known compound may suggest its analogs or isomers, either geometric isomers (cis v. trans) or position isomers (e.g., ortho v. para). In all of these cases, however, the prior art teaches a specific, structurally-definable compound and the question becomes whether the prior art would have suggested making the specific molecular modifications necessary to achieve the claimed invention.in the past, the court has held that structural similarity between claimed and prior art subject matter, ... where the prior art

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gives reason or motivation to make the claimed compositions, creates a prima facie case of obviousness. The prior art must provide one of ordinary skill in the art the motivation to make the proposed molecular modifications needed to arrive at the claimed compound. Here, the prior art does not disclose any relevant cDNA molecules, let alone close relatives of the specific, structurally-defined cDNA molecules of claims 5 and 7 that might render them obvious. The Maniatis case suggests an allegedly obvious process for trying to isolate cDNA molecules, but that, as we will indicate below, does not fill the gap regarding the subject matter of claims 5 and 7. Further, while the general idea of the claimed molecules, their function, and their general chemical nature may have been obvious from Bohlen's teachings, and the knowledge that some gene existed may have been clear, the precise cDNA molecules of claims 5 and 7 would not have been obvious over the Bohlen reference because Bohlen teaches proteins, not the claimed or closely related cDNA molecules. The redundancy of the genetic code precluded contemplation of or focus on the specific cDNA molecules of claims 5 and 7. Thus, one could not have conceived the subject matter of claims 5 and 7 based on the teachings in the cited prior art because, until the claimed molecules were actually isolated and purified, it would have been highly unlikely for one of ordinary skill in the art to contemplate what was ultimately obtained. What cannot be contemplated or conceived cannot be obvious. The Board's theory that one might have been motivated to try to do what Deuel in fact accomplished amounts to speculation and an impermissible hindsight reconstruction of the claimed invention. It also ignores the fact that claims 5 and 7 are limited to specific compounds, and any motivation that existed was a general one, to try to obtain a gene that was yet undefined and may have constituted many forms. A general motivation to search for some gene that exists does not necessarily make obvious a specifically-defined gene that is subsequently obtained as a result of that search. More is needed and it is not found here.

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