2009 Howrey LLP 1 COMMON USPTO REJECTIONS COMMON USPTO REJECTIONS OBVIOUSNESS. Learned Hand on Obviousness. The Graham Factors

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1 COMMON USPTO REJECTIONS IMPORTANT CASE LAW and RECENT PHAMA CASE LAW Viola T. Kung, Ph.D. Prior art rejections 35 U.S.C 102, Novelty 35 U.S.C 103, Obviousness Supreme court case: KSR June COMMON USPTO REJECTIONS 35 U.S.C 112, first paragraph, enabling Do you teach how to make and use the invention? Any working examples (data) in the application? OBVIOUSNESS KSR International Co. v. Teleflex Inc. 127 S. Ct (2007) 3 4 Learned Hand on Obviousness Substantially all inventions are for the combination of old elements What counts is the selection, out of all their possible permutations, of that new combination No objective standard is practicable The Graham Factors 1. The scope and content of the prior art; 2. The differences between the claimed invention and the prior art; 3. The level of ordinary skill in the art; and 4. Other objective indicia of non-obviousness, such as commercial success of the claimed invention, long felt but unmet need, failure of others. Safety Car Heating & Lighting Co. v. General Elec. Co., 155 F.2d 937, 939 (2d Cir. 1946) Graham v. John Deere Co., 383 U.S. 1 (1966) Howrey LLP 1

2 KSR District Court Opinion adjustable pedal assemblies have existed in the art since the late 1970s. Clearly, it was inevitable that adjustable pedal assemblies would be joined with an electronic device to work in conjunction with modern electronically controlled engines. Federal Circuit s TSM Test When obviousness is based on the teachings of multiple prior art references, the movant must also establish some suggestion, teaching or motivation that would have led a person of ordinary skill in the art to combine the relevant prior art teachings in the manner claimed. Teleflex Inc. v. KSR International, 298 F.Supp.2d 581, 593 (E.D. Mich. 2003) Teleflex, Inc. v. KSR International, 119 Fed. Appx. 282, 285 (Fed. Cir. 2005) 7 8 Federal Circuit s TSM Test Motivation or suggestion may be found: in the prior art itself reasonable inference of the nature of the problem to be solved knowledge of those of ordinary skill in the art. Scalia on TSM - Gobbledygook It is misleading to say that the whole world is embraced within these three nouns, teaching, suggestion, or motivation, and then you define teaching, suggestion, or motivation to mean anything that renders it nonobvious. This is gobbledygook. It really is, it's irrational. -- JUSTICE SCALIA (Transcript of Oral Argument) Teleflex Inc. v. KSR International, 119 Fed. Appx. 282, 285 (Fed. Cir. 2005) 9 10 KSR Summary All you need are Graham factors and a little flexibility TSM approach too rigid Obvious-to-try and other rationales for rejection are okay if predictable results Rationales may be based on common sense, problems from other fields, normal creativity TSM Not Necessary Rationale for obviousness can come from various sources including: Basic knowledge and/or common sense of one of ordinary skill in the art design need or market pressure to solve a problem Howrey LLP 2

3 Obvious to Try May Be Enough When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under 103. KSR KSR Applied by the USPTO USPTO S S KSR Guidelines Summarizes KSR opinion Emphasizes all key points of departure Reiterates Graham factors as initial fact finding framework Provides 7 Rationales to Support Rejections USPTO Examination BEFORE KSR 103 prima facie case requires: All claim limitations Teaching, suggestion or motivation to combine Reasonable expectation of success USPTO Examination AFTER KSR 103 prima facie case requires: All claim limitations Teaching, suggestion or motivation to combine Articulated rationale to support obviousness Reasonable expectation of success Examiner Must Articulate a Rationale [R]ejections on obviousness grounds cannot be sustained by mere conclusory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness ). KSR (citing In re Kahn) Howrey LLP 3

4 USPTO s 7 Rationales Combinations of known elements 1. Combining prior art elements according to known methods to yield predictable results 2. Simple substitution of one known element for another to obtain predictable results USPTO s 7 Rationales Applying known improvements 3. Use of known technique to improve similar devices (methods, or products) in the same way 4. Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results USPTO s s 7 Rationales Obvious to try 5. Obvious to try choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; USPTO s s 7 Rationales Predictable cross-field variations 6. Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations would have been predictable to one of ordinary skill in the art; USPTO s s 7 Rationales TSM 7. Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention. 7 New Reasons to Reject (More Gobbledygook) TSM TSM now just one of numerous rationales available to an Examiner for establishing a prima facie case. Much more difficult to argue against common sense and obvious to try than TSM Howrey LLP 4

5 INJUNCTION No (US Sup. Ct.) U.S. 388 (2006) MercExchange sought to license its patent to ebay but parties failed to reach an agreement. As a result, MercExchange filed patent infringement suit District Court: Denied MercExchange s motion for permanent injunctive relief. Jury found: valid patent, infringement, monetary damages. Court of Appeals: Reversed lower court. Granted permanent injunction. Supreme Court Vacate injunction and remand to District Court. The decision whether to grant or deny injunctive relief rests within the equitable discretion of the district court. Discretion must be exercised consistent with traditional principles of equity factor test for injunction: Plaintiff has suffered an irreparable injury. Remedies available at law, such as monetary damages, are inadequate to compensate for the injury. Considering the balance of hardships between plaintiff & defendant, a remedy in equity is warranted. Public interest would not be disserved by a permanent injunction. Court will no longer automatically grant injunctions. May be difficult to establish need for permanent injunction Howrey LLP 5

6 Impax v. Aventis, 545 F.3d 1312 (October 2008) Is laundry list disclosure an enabling prior art? USPN 5,527,814 claims a method of treating amyotrophic lateral sclerosis (ALS) using 2- amino-6-(trifluoromethoxy) benzothiazole (riluzole) Claim 1. A method for treating a mammal with amyotrophic lateral sclerosis, comprising the step of administering to said mammal in recognized need of said treatment an effective amount of 2-amino-6- (trifluoromethoxy)benzothiazole or a pharmaceutically acceptable salt thereof. Prior Art USPN 5,236,940 discloses a generic formula I, when R1= trifluoromethoxy, R2=R3=H, the structure is equal to riluzole USPN 5,236,940 (prior art) discloses: R1 is polyfluoroalkoxy, 2,2,2-tri-fluoroethyl, pentafluoroethyl, tert-butyl, trimethylsilyl or trifluoromethylthio and R2 and R.3 are hydrogen, or R1 is polyfluoroalkoxy, R2 is hydrogen and R3 is alkyl, amino, alkoxy, phenyl, phenylalkyl, dimethylamino or dialkylaminoakylthio, or R1 is polyfluoroalkoxy, R2 is amino and R3 is hydrogen, provided that The prior art reference discloses: The compounds of formula (I) are useful in treating diseases associated with the effects of glutamate. ALS was one of the 9 diseases listed in the paragraph Howrey LLP 6

7 The prior art reference discloses: convulsive phenomena, schizophrenic disorders, and in particular the deficiency forms of schizophrenia, sleep disorders, phenomena linked to cerebral ischaemia and also neurological conditions in which glutamate may be implicated, such as Alzheimer's disease, Huntington's chorea, amyotrophic lateral sclerosis and olivopontocerebellar atrophy. The district court found that based on 940 Patent, excessive experimentation would have been necessary to practice the invention. One of ordinary skill in the pharmaceutical arts would have needed extensive experimentation to link riluzole with the treatment of ALS Formula I of the alleged prior art discloses hundreds or thousands of compounds and several diseases Nothing in the reference would direct one skilled in the art to recognize that riluzole could be used to treat ALS. Rejected the notion that "the mere mention of riluzole is sufficient to put one skilled in the art in the possession of the claimed invention." Appeal Court affirms. The prior art dosage guidelines are broad and general without sufficient direction or guidance to prescribe a treatment regimen The alleged prior art also contains no working examples. Nothing in the prior art would have led one of skill in the art to identify riluzole as a treatment for ALS. Each component of the claimed invention-- identifying riluzole as a treatment for ALS and devising dosage parameters--would require undue experimentation based on the teachings of the prior art. Because prior art is not enabling, it does not anticipate the claims Howrey LLP 7

8 Sanofi-Synthelabo Synthelabo v. Apotex,, 550 F.3d 1075 (December 2008) Does prior art disclosure of racemates anticipate a separated enantiomer? Sanofi v. Apotex USPN 4,874,265 (Sanofi) (Clopidogrel bisulfate), Patent in Suit Claim 3. Hydrogen sulfate of the dextro-rotatory isomer of methyl alpha-5(4,5,6,7-tetrahydro(3,2- c)thieno pyridyl) (2-chlorophenyl)-acetate substantially separated from the levo-rotatory isomer Sanofi v. Apotex (cont Prior At: USPN 4,529,596 (Sanofi), discloses: These compounds having an asymmetrical carbon may exist in the form of two enantiomers. The invention relates both to each enantiomer and their mixture. Sanofi v. Apotex (cont Sanofi does not dispute the statement of stereochemistry in prior art. However, knowledge of the existence of enantiomer is not a description of a specific enantiomer substantially separated from the other. The court found that the asserted references are not enabling, for they contain no guidance as to how to separate the enantiomers Sanofi v. Apotex (cont To anticipate, the reference: must not only disclose all elements of the claim within the four corners of the document, but must also disclose those elements arranged as in the claim. Sanofi v. Apotex (cont To anticipate, the reference: must clearly and unequivocally disclose the claimed invention, must direct those skilled in the art to the invention, without any need for picking, choosing, without combining various disclosures not directly related to each other by the teachings of the cited reference Howrey LLP 8

9 Sanofi v. Apotex (cont Non-Obviousness: Absolute Stereoselectivity The dextrorotatory enantiomer: favorable antiplatelet activity, no neurotoxicity. The levorotatory enantiomer: no antiplatelet activity, with neurotoxicity. Product by-process Claim Abbott Labs. v. Sandoz Inc , 2009 U.S. App. LEXIS (Fed. Cir. May 18, 2009) Abbott Labs. v. Sandoz Inc. (Cont (Cont d) Abbott Labs. v. Sandoz Inc. (Cont (Cont d) What is a product-by-process claim? An inventor invents a product whose structure is either not fully known or too complex to analyze, the inventor can use process steps to define this product. A product X made by the process of: steps (a), (b),.. If someone makes identical product X by a different process, does he infringe the product-by-process claim? Abbott Labs. v. Sandoz Inc. (Cont FACTS (Cont d) Abbott Labs is exclusive licensee of U.S. Pat 4,935,507. Markets crystalline cefdinir (Form A) according of the 507 patent (trade name Omnicef) Abbott Labs. v. Sandoz Inc. (cont The 507 Patent Claims 2-5 are product-by-process claims. 2. Crystalline Compound X which is obtainable by acidifying a solution containing Compound X at room temperature or under warming Howrey LLP 9

10 Abbott Labs. v. Sandoz Inc. (cont PROCEDURAL HISTORY 2 cases involving the 507 patent Lupin s generic product almost exclusively Form B of crystalline cefdinir. made by processes other than those claimed in the 507 patent E.D. of Va.- Court granted-in-part Lupin s motion on SJ of noninfringement. Abbott Labs. v. Sandoz Inc. (cont PROCEDURAL HISTORY Sandoz and Teva previously filed ANDAs, also seeking to market generic versions of Omnicef. N.D. of Ill. Court denied Abbott s preliminary injunction Abbott appealed both decisions Abbott Labs. v. Sandoz Inc. (cont ISSUE Is a product-by-process claim infringed by products made by processes other than the one claimed? HOLDING NO process terms in product-by-process claims serve as limitations in determining infringement. Id. at * Abbott Labs. v. Sandoz Inc. (cont RATIONALE If an inventor invents a product whose structure is either not fully known or too complex to analyze, the inventor is absolutely free to use process steps to define this product Abbott Labs. v. Sandoz Inc. (cont Because the inventor chose to claim the product in terms of its process, that definition also governs the enforcement of the bounds of the patent right. This court cannot simply ignore as verbiage the only definition supplied by the inventor. Id. at * Howrey LLP 10