ksr_1600_slideset - Obviousness in view of KSR Obviousness...

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Unformatted text preview: Obviousness in view of KSR Obviousness TC1600-Specific Examples The Basic Approach to Determining The Obviousness Remains the Same Obviousness s s KSR International Co. v. Teleflex Inc., 550 U.S. —, 82 USPQ2d 1385 (2007) An examiner is still required to provide a reasoned statement of rejection grounded in the Graham inquiries. He or she must articulate a reason or rationale to support the obviousness rejection. See KSR at 1396 ("To facilitate review, [the obviousness] analysis should be made explicit.") (citing In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006)). s 2 Any Reasoned Argument Grounded in Any Graham May Form the Basis for a Prima Graham Facie Case of Obviousness Facie s "If a court, or patent examiner, conducts [the Graham] analysis and concludes the claimed subject matter was obvious, the claim is invalid under § 103.” KSR at 1391. "The obviousness analysis cannot be confined by a formalistic conception of the words teaching, suggestion, and motivation, or by overemphasis on the importance of published articles and the explicit content of issued patents." KSR at 1396. s 3 The Examiner as The Fact Finder Fact s Examiners act as fact finders when resolving the Graham inquiries. Examiners must articulate findings of fact to support the obviousness rejection being made. s 4 Key Points s Examiners must account for all claim limitations in their rejections by explaining how each limitation is disclosed or rendered obvious by the reference(s) applied 5 Key Points s Prior art is not limited to the four corners of the documentary prior art being applied. Prior art includes both the specialized understanding of one of ordinary skill in the art, and the common understanding of the layman. It includes "background knowledge possessed by a person having ordinary skill in the art. . . . [A] court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ." KSR at 1396. 6 Making a Prima Facie Case of Making Prima Obviousness Obviousness Examiners must: s s s Resolve the Graham inquiries Articulate appropriate factual findings Explain the reasoning that provides a nexus between the factual findings and the legal conclusion of obviousness 7 Rationales s One or more of the rationales set forth in the following slides may be relied upon to support a conclusion of obviousness The list of rationales provided herein is not intended to be an all­inclusive list The key to supporting any rejection under 35 U.S.C. § 103 is the clear articulation of the reasons why the claimed invention would have been obvious. s s 8 Rationales Supporting a Prima Facie Rationales Prima Case of Obviousness Case s s s s Combining prior art elements according to known Combining methods to yield predictable results methods Simple substitution of one known, equivalent element Simple for another to obtain predictable results for Use of known technique to improve similar devices Use (methods, or products) in the same way (methods, Applying a known technique to a known device Applying (method, or product) ready for improvement to yield predictable results predictable 9 Rationales Supporting a Prima Facie Rationales Prima Case of Obviousness Case s s "Obvious to try" – choosing from a finite number of "Obvious predictable solutions predictable Known work in one field of endeavor may prompt Known 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 predictable Teaching, suggestion, or motivation, either in the references themselves or in the knowledge generally available to one of ordinary skill in the art, to modify the reference or to combine reference teachings s 10 10 Example 1 s Claims A therapeutic composition comprising hematopoietic stem cells obtained from umbilical cord blood and a cryopreservative A method for hematopoietic or immune reconstitution comprising cryopreservation of hematopoietic stem cells obtained from umbilical cord blood , thawing, and administering said cells to a human 11 11 Example 1 s Prior Art Reference identifies the presence of stem cells in umbilical cord blood Reference teaches that stem cells in umbilical cord blood could be cryopreserved and thawed Reference suggests the use of stem cells from cord blood for transplantation and hematopoietic reconstitution 12 12 Example 1 s Evidence Declarations by expert asserting Prior art used “flawed nomenclature” Problems with prior transplants of analogous stem cells (blood, marrow) Surprise by those in the art at the success of the invention 13 13 Example 1 s Evidence Statements in the specification defining both stem cells and progenitors are consistent with art­ recognized definitions of stem cells and progenitors 14 14 Example 1 s Conclusion It would have been obvious to one of ordinary skill in the art at the time the invention was made to collect, cryopreserve, store and administer hematopoietic stem cells from umbilical cord blood to an individual in need of hematopoietic reconstitution with a reasonable expectation of success because the prior art suggests that umbilical cord blood may be successfully used in hematopoietic reconstitution and may be successfully cryopreserved without loss of viability of the stem cells contained therein 15 15 Pharmastem Therapeutics, Inc. v. Viacell, Inc., 491 F.3d 1342, 83 USPQ2d 1289 (Fed. Cir. 2007) s Court’s Analysis Could not reconcile expert testimony with statements in the specification Did not agree with expert that terminology was “flawed” Prior art references to “stem cells” were consistent with Applicants’ statements in the specification Citing KSR, determined that invention was confirmation of what was already believed to be true 16 16 Example 2 s Claim The besylate salt of amlodipine 17 17 Example 2 s Prior Art Patent disclosing amlodipine and pharmaceutically­acceptable acid addition salts and specifically names hydrochloride, hydrobromide, sulphate, phosphate, acid phosphate, acetate, maleate, fumarate, lactate, tartrate, citrate, and gluconate salts Reference disclosing 53 FDA­approved commercially­marketed anions useful for making pharmaceutically acceptable salts and specifically names besylate as one of those salts whose frequency of use was 0.25% 18 18 Example 2 s Evidence Inventor declaration asserting that the besylate salt of amlodipine possessed good solubility, stability, non­ hygroscopicity and processability which were “unpredictable both individually and collectively” and was superior to prior art amlodipine maleate salt 19 19 Example 2 s Conclusion It would have been obvious to one of ordinary skill in the art at the time the invention was made to choose from a finite number of predictable pharmaceutically acceptable salt options of amlodipine with a reasonable expectation of success of producing a functional amlodipine formulation 20 20 Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 82 USPQ2d 1321 (Fed. Cir. 2007) s Court’s Analysis Suggestion, teaching or motivation does not have be explicit and “may be found in any number of sources, including common knowledge, the prior art as a whole or the nature of the problem itself”, citing Dystar Textilfarben GMBH v. C.H. Patrick Co., 464 F.3d 1356 (Fed. Cir. 2006) Formulations must be tested by routine procedures to verify expected properties 21 21 Example 3 s Claim 5­4­[2­(5­ethyl­2­pyridyl)ethoxy]benzyl­ 2,4­thiazolidinedione (a thiazolidinedione (TZD) with the ethyl group at the 5­position pyridyl ring) 22 22 Example 3 s Prior Art Patent disclosing an effective anti­ diabetic compound, “Compound 42” (out of 60), which differs from the claimed compound in two ways methyl in place of ethyl substitution in the 6­position instead of the 5­ position References discussing the conventional practices of homologation and ring­ walking 23 23 Example 3 s Prior Art Review article of 101 TZD compounds, which specifically singles out “Compound 42” as having negative side effects of increasing body weight and percentage brown fat 24 24 Example 3 s Evidence Compound 42 produced significant toxicity to the liver and heart as well as a decrease in the number of erythrocytes, a sign of potential toxicity to bone marrow Claimed compound showed no statistically significant toxicity 25 25 Example 3 s Conclusion The claimed compound would not have been obvious to one of ordinary skill in the art at the time the invention was made due to evidence of teaching away and unexpected properties 26 26 Takeda Chemical Industries v. Alphapharm Pty, Ltd., 492 F.3d 1350, 83 USPQ2d 1169 (Fed. Cir. 2007) s Court’s Analysis No “finite number of identifiable, predictable solutions” Prior art provided “broad selection of compounds” Closest prior art compound exhibited negative properties 27 27 Highlights and Guidance s Evidence is critical to the determination of obviousness Example 1 ­ Applicants’ statements in specification were consistent with the prior art and inconsistent with expert testimony Example 2 – Evidence of unexpected results may be insufficient to overcome a conclusion of obviousness Example 3 ­ Evidence of “teaching away” combined with unexpected results were sufficient to outweigh evidence of obviousness 28 28 Example 4 s Claim Solid oral dosage form comprising (a) coated famotidine granules (b) Al(OH)3 or Mg(OH)2 granules wherein the coating on the famotidine is impermeable to the Al(OH)3 or Mg(OH)2 29 29 Example 4 s Prior Art Reference disclosed combination of uncoated histamine H2 receptor antagonists (e.g. famotidine) and antacids Reference disclosed coating granulated medicaments to mask taste of active ingredient Reference acknowledged the bitter taste of cimetidine (a famotidine analog) 30 30 Example 4 s Evidence Other modes of taste­masking were preferable due to cost of coated granules 31 31 Example 4 s Conclusion It would have been obvious to one of ordinary skill in the art at the time the invention was made to apply a known taste­masking technique to mask the expected bitter taste of famotidine by coating the famotidine granules with the predictable expectation that the formulation will be more palatable 32 32 McNeil­PPC, Inc. v Perrigo Company, 516 F. Supp.2d 238 (S.D. N.Y. July 3, 2007) s Court’s Rationale The combination of coated famotidine and the antacids provided no more than predictable results, citing KSR Costs alone are not indicative of non­ obviousness 33 33 Example 5 s Claim A formulation comprising (a) a core comprising omeprazole plus an alkaline reacting compound (ARC); (b) an inert subcoating, which is soluble or rapidly disintegrates in water, disposed on the core region, (c) an outer layer disposed on the subcoating comprising an enteric coating 34 34 Example 5 s Prior Art References disclose drugs formulated in a core with a subcoating and enteric coating but do not disclose omeprazole References disclose omeprazole but do not disclose coatings or an alkaline reacting compound References describe subcoating techniques but do not disclose omeprazole – subcoatings should not be used with moisture­sensitive drugs 35 35 Example 5 s Evidence Omeprazole is acid labile, sensitive to heat, moisture, solvents and light Expert testimony of “multitude of possible paths and dead­ends” in formulation attempts 36 36 Example 5 s Conclusion It would not have been obvious to one of ordinary skill in the art at the time the invention was made to formulate omeprazole with an alkaline reacting compound and then sub­coat and enterically coat the combination 37 37 In re Omeprazole Patent Litigation, 490 F. Supp. 2d 381 (S.D. N.Y. June 1, 2007) s Court’s Analysis Prior art compounds that were subcoated and coated were not comparable to omeprazole Prior art taught away from the subcoated formulation Prior art disclosure to omeprazole formulations did not disclose stability problems 38 38 Highlights and Guidance s Recognition of problems in the prior art as well as answers to problems in the prior art may lead to a finding of obviousness In Example 4, single problem is solved with predictable results In Example 5, numerous variables suggested that the results would not be predictable 39 39 Example 6 s Claim An isolated nucleic acid molecule comprising a polynucleotide encoding a polypeptide at least 80% identical to amino acids 22 – 221 of SEQ ID NO:2, wherein the polypeptide binds CD48 40 40 Example 6 s Prior Art Reference disclosed p38 protein (same protein as NAIL) and methods of isolation by using mAbs as well as methods of obtaining the polynucleotide sequence but does not disclose the sequence of p38 Reference disclosed the nucleic acid sequence of the highly conserved murine version of p38 and identified a human homologue 41 41 Example 6 s Conclusion One of ordinary skill in the art would have been motivated to isolate and identify the claimed nucleotide sequence based on the prior art disclosure of the p38 protein by applying conventional methodologies 42 42 Ex parte Kubin, 83 USPQ2d 1410 (Bd. Pat. App. & Int. 2007) s Board’s Analysis State of the art has advanced Reliance on KSR – “obvious to try” in view of limited methodologies available to isolate NAIL cDNA Methodologies had reasonable expectation of success 43 43 Highlights and Guidance s Advancements in the state of the art may render that which was once unpredictable to become predictable Regularly review the state of the art that is examined Take of note of changes in the state of the art 44 44 Example 7 s Claim An antivenom pharmaceutical composition for treating a snakebite victim, comprising Fab fragments which bind specifically to a venom of a snake of the Crotalus genus essentially free from contaminating Fc and a pharmaceutically acceptablecarrier, which neutralizes the lethality of the venom of a snake of the Crotalus genus 45 45 Example 7 s Prior Art Reference teaches whole antibodies purified from horse serum for use as an antivenom for treatment of rattlesnake bites Reference teaches producing Fab fragments from whole antibodies for use in immunoassays to detect textilotoxin 46 46 Example 7 s Evidence Declaration discussing state of the art of antivenoms which, since 1969, have only been commercially available as whole antibodies or F(ab)2 fragments Declaration stating that those in the art would not have considered Fab fragments as antivenoms because they are cleared faster than whole antibodies or F(ab)2 fragments 47 47 Example 7 s Evidence Declaration discussing success of whole antibody antivenom dependent on extra disulfide bond allowing whole antibody to bind to repeating protein antigens ­ Fab fragment does not contain such a bond but surprisingly binds and neutralizes venom Declaration showing decreased adverse immune reactions 48 48 Example 7 s Conclusion To be determined! Federal Circuit vacates decision of the Board that affirmed the Examiner’s conclusion of obviousness Remanded to the Board for evaluation of rebuttal evidence 49 49 In re Sullivan, 498 F.3d 1345, 84 USPQ2d 1034 (Fed. Cir. 2007) s Court’s Analysis The Board asserted that the declarations related only to use and expressly declined to give any meaningful consideration to them because the claims were drawn to the composition The court found that the board erred in failing to consider rebuttal evidence 50 50 Highlights and Guidance s Do not ignore any terms in a claim Determine whether any claimed function requires or implies a structural limitation Explain how the prior art renders obvious the functional limitation, i.e. how the invention rendered obvious by the prior art is suitable for and/or capable of carrying out the claimed function 51 51 Example 8 s Claim A method for treating otopathy which comprises the topical otic administration of an amount of ofloxacin or a salt thereof effective to treat otopathy in a pharmaceutically acceptable carrier to the area affected with otopathy 52 52 Example 8 s Prior Art Reference teaches lack of ototoxicity of ciprofloxacin when used to treat middle ear infections Reference teaches that ofloxacin and ciprofloxacin are both gyrase inhibitors and belong to the same family of compounds 53 53 Example 8 s Conclusion It would have been obvious to one of ordinary skill in the art at the time the invention was made to substitute ofloxacin for ciprofloxacin in the treatment of otopathy with a predictable expectation of successful treatment due to the compounds’ structural and functional similarities 54 54 Daiichi Sankyo Co. v. Apotex, Inc., 501 F.3d 1254, 84 USPQ2d 1285 (Fed. Cir. 2007) s Court’s Analysis District Court erred in the determination of the level of skill By finding the level of skill in the prior art to be too high, prior art teaching was dismissed by the District Court 55 55 Highlights and Guidance s Resolving the level of ordinary skill may be explicit or implicit in view of the prior art applied When making an obviousness rejection, examiners are only required to make an explicit statement addressing the level of ordinary skill in the art when the level of ordinary skill is not clear in light of the cited prior art (Union Carbide Corp. v. American Can Co., 724 F.2d 1567, 1573 (Fed. Cir. 1984)) s 56 56 Example 9 s Claim The 5(S) stereoisomer of ramipril substantially free of other isomers 57 57 Example 9 s Prior Art References teach that related ACE­inhibiting therapeutic compounds (BPP5a, captopril, and enalapril) are most therapeutically active in the S configuration “Parent” patent disclosing structurally similar compounds and teaching that when diastereomeric products result from the synthetic procedures, the diasteriomeric products can be separated by conventional chromatographic or fractional crystallization methods 58 58 Example 9 s Evidence Synthesis of a mixture of the 5(S) stereoisomer with the 4(S)(R) stereoisomer of ramipril by competitor pharmaceutical company (which qualified as prior art under 102(g)) 59 59 Example 9 s Conclusion It would have been obvious to one of ordinary skill in the art at the time the invention was made to produce and isolate the 5(S) stereoisomer of ramipril with a reasonable expectation of success 60 60 Aventis v. Lupin, 499 F.3d 1293, 84 USPQ2d 1197 (Fed. Cir. 2007) s Court’s Analysis District Court erred in requiring clear and convincing showing of motivation, citing KSR Obviousness flowed from recognition of the properties of similar prior art compounds combined with recognition of the presence of the claimed isomer in the prior art mixture 61 61 Example 10 s Claim Substantially pure (S) enantiomer of escitalopram oxalate 62 62 Example 10 s Prior Art Reference taught racemate of escitalopram as a SSRI and predicted enhanced potency of the (R) enantiomer but did not disclose the process of separation of the racemate 63 63 Example 10 Evidence Chiral HPLC was a relatively new and unpredictable technique at the time of the invention Author of prior art reference had attempted to use chiral HPLC to separate racemate of escitalopram but failed Failure by inventor to resolve escitalopram racemate by diasteriomeric salt formation 64 64 Example 10 Conclusion It would not have been obvious to one of ordinary skill in the art at the time the invention was made to produce the substantially pure (S) enantiomer of escitalopram oxalate with a reasonable expectation of success 65 65 Forest Laboratories v Ivax Pharmaceuticals, 501 F.3d 1263, 84 USPQ2d 1099 (Fed. Cir. 2007) s Court’s Analysis District Court’s finding that the prior art reference was not enabling with regard to the isolation of (S) enantiomer was not in error 66 66 Highlights and Guidance s Evidence Consider the invention as a whole and all of the evidence presented The question under 35 U.S.C. 103 is not whether the differences themselves would have been obvious, but whether the claimed invention as a whole would have been obvious 67 67 Example 11 Claim A transgenic corn plant that produces a Bt protein where the foreign DNA nucleic acid coding sequence has a G+C content of at least about 60% 68 68 Example 11 Prior Art Published patent application describing a method for improving Bt expression in tobacco plant genes by selecting codons that are rich in G+C to increase expression efficiency of the Bt protein and asserting that the methodology would be equally applicable in other plant species 69 69 Example 11 Evidence Declaration showing total sales of transgenic corn and asserting commercial success 70 70 Example 11 Conclusion It would have been obvious to one of ordinary skill in the art to modifying the Bt DNA sequence by selecting codons for the Bt amino acid sequence that are rich in G+C with a reasonable expectation of improved expression of Bt in by the corn plant and optimizing the percentage G+C to produce desired expression 71 71 Syngenta Seeds v. Monsanto, (Fed. Cir. 2007) Court’s Analysis A non­precedential decision after KSR District Court correctly used the Graham factors 72 72 Highlights and Guidance When deciding questions of obviousness Determine the facts Weigh the evidence – including secondary considerations Articulate rationales Explain conclusions 73 73 Thank You! s s s Jean Witz, tQAS TC1600 2­0927 Remsen 4D25 74 74 ...
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