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SKGF_Presentation_Hot Topics in US Patent Practice-08
SKGF_Presentation_Hot Topics in US Patent Practice-08
SKGF_Presentation_Hot Topics in US Patent Practice-08
SKGF_Presentation_Hot Topics in US Patent Practice-08
SKGF_Presentation_Hot Topics in US Patent Practice-08
SKGF_Presentation_Hot Topics in US Patent Practice-08
SKGF_Presentation_Hot Topics in US Patent Practice-08
SKGF_Presentation_Hot Topics in US Patent Practice-08
SKGF_Presentation_Hot Topics in US Patent Practice-08
SKGF_Presentation_Hot Topics in US Patent Practice-08
SKGF_Presentation_Hot Topics in US Patent Practice-08
SKGF_Presentation_Hot Topics in US Patent Practice-08
SKGF_Presentation_Hot Topics in US Patent Practice-08
SKGF_Presentation_Hot Topics in US Patent Practice-08
SKGF_Presentation_Hot Topics in US Patent Practice-08
SKGF_Presentation_Hot Topics in US Patent Practice-08
SKGF_Presentation_Hot Topics in US Patent Practice-08
SKGF_Presentation_Hot Topics in US Patent Practice-08
SKGF_Presentation_Hot Topics in US Patent Practice-08
SKGF_Presentation_Hot Topics in US Patent Practice-08
SKGF_Presentation_Hot Topics in US Patent Practice-08
SKGF_Presentation_Hot Topics in US Patent Practice-08
SKGF_Presentation_Hot Topics in US Patent Practice-08
SKGF_Presentation_Hot Topics in US Patent Practice-08
SKGF_Presentation_Hot Topics in US Patent Practice-08
SKGF_Presentation_Hot Topics in US Patent Practice-08
SKGF_Presentation_Hot Topics in US Patent Practice-08
SKGF_Presentation_Hot Topics in US Patent Practice-08
SKGF_Presentation_Hot Topics in US Patent Practice-08
SKGF_Presentation_Hot Topics in US Patent Practice-08
SKGF_Presentation_Hot Topics in US Patent Practice-08
SKGF_Presentation_Hot Topics in US Patent Practice-08
SKGF_Presentation_Hot Topics in US Patent Practice-08
SKGF_Presentation_Hot Topics in US Patent Practice-08
SKGF_Presentation_Hot Topics in US Patent Practice-08
SKGF_Presentation_Hot Topics in US Patent Practice-08
SKGF_Presentation_Hot Topics in US Patent Practice-08
SKGF_Presentation_Hot Topics in US Patent Practice-08
SKGF_Presentation_Hot Topics in US Patent Practice-08
SKGF_Presentation_Hot Topics in US Patent Practice-08
SKGF_Presentation_Hot Topics in US Patent Practice-08
SKGF_Presentation_Hot Topics in US Patent Practice-08
SKGF_Presentation_Hot Topics in US Patent Practice-08
SKGF_Presentation_Hot Topics in US Patent Practice-08
SKGF_Presentation_Hot Topics in US Patent Practice-08
SKGF_Presentation_Hot Topics in US Patent Practice-08
SKGF_Presentation_Hot Topics in US Patent Practice-08
SKGF_Presentation_Hot Topics in US Patent Practice-08
SKGF_Presentation_Hot Topics in US Patent Practice-08
SKGF_Presentation_Hot Topics in US Patent Practice-08
SKGF_Presentation_Hot Topics in US Patent Practice-08
SKGF_Presentation_Hot Topics in US Patent Practice-08
SKGF_Presentation_Hot Topics in US Patent Practice-08
SKGF_Presentation_Hot Topics in US Patent Practice-08
SKGF_Presentation_Hot Topics in US Patent Practice-08
SKGF_Presentation_Hot Topics in US Patent Practice-08
SKGF_Presentation_Hot Topics in US Patent Practice-08
SKGF_Presentation_Hot Topics in US Patent Practice-08
SKGF_Presentation_Hot Topics in US Patent Practice-08
SKGF_Presentation_Hot Topics in US Patent Practice-08
SKGF_Presentation_Hot Topics in US Patent Practice-08
SKGF_Presentation_Hot Topics in US Patent Practice-08
SKGF_Presentation_Hot Topics in US Patent Practice-08
SKGF_Presentation_Hot Topics in US Patent Practice-08
SKGF_Presentation_Hot Topics in US Patent Practice-08
SKGF_Presentation_Hot Topics in US Patent Practice-08
SKGF_Presentation_Hot Topics in US Patent Practice-08
SKGF_Presentation_Hot Topics in US Patent Practice-08
SKGF_Presentation_Hot Topics in US Patent Practice-08
SKGF_Presentation_Hot Topics in US Patent Practice-08
SKGF_Presentation_Hot Topics in US Patent Practice-08
SKGF_Presentation_Hot Topics in US Patent Practice-08
SKGF_Presentation_Hot Topics in US Patent Practice-08
SKGF_Presentation_Hot Topics in US Patent Practice-08
SKGF_Presentation_Hot Topics in US Patent Practice-08
SKGF_Presentation_Hot Topics in US Patent Practice-08
SKGF_Presentation_Hot Topics in US Patent Practice-08
SKGF_Presentation_Hot Topics in US Patent Practice-08
SKGF_Presentation_Hot Topics in US Patent Practice-08
SKGF_Presentation_Hot Topics in US Patent Practice-08
SKGF_Presentation_Hot Topics in US Patent Practice-08
SKGF_Presentation_Hot Topics in US Patent Practice-08
SKGF_Presentation_Hot Topics in US Patent Practice-08
SKGF_Presentation_Hot Topics in US Patent Practice-08
SKGF_Presentation_Hot Topics in US Patent Practice-08
SKGF_Presentation_Hot Topics in US Patent Practice-08
SKGF_Presentation_Hot Topics in US Patent Practice-08
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SKGF_Presentation_Hot Topics in US Patent Practice-08

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  • 1. Hot Topics in US Patent Practice May, 2008 Michele A. Cimbala, Esq. mcimbala@SKGF.com Sterne, Kessler, Goldstein & Fox P.L.L.C. 1 iManage No. 8257141
  • 2. Hot Topic Legislative Action The Patent Reform Act of 2007 2
  • 3. Patent Reform Act of 2007 Most likely dead for this session H.R. 1908 (passed by House of Representatives, September 7, 2007) S. 1145 (reported out of the Senate Judiciary Committee, July 19, 2007 Effective Date – would be 12 months after enactment – Generally will affect patents issuing after effective date regardless of filing – date 3 3
  • 4. Patent Reform Act: Highlights Harmonization aspects Best mode requirement: uncertain status First to file: could be implemented w/conditions Post-grant opposition procedure: new procedure Especially hot issues for U.S. prosecution Inequitable conduct: change to the standard Search report by applicant (AQS): mandatory 4
  • 5. Post Grant Opposition Any Ground related to invalidity – (101, 102, 103, Double Patenting) Timing – First Window 12 months Second Window anytime (litigation threat; reason to believe cause of significant economic harm; consent) Discovery, Sanctions and Protective Orders – Burden of Proof – preponderance – no presumption of validity – One year to decision (extendable by 6 months) – Estoppel – for litigation and other proceedings – Same grounds actually raised (not ‘could have been” raised) Effective Date – 1 year after enactment. – 5 5
  • 6. Enhanced Rule Making Authority Patent Reform Act (continued): Gives the USPTO the authority to make rules – without Congressional approval (*hot issue*) Easy adoption of previously proposed rules – Continuations Claims Limitations IDS 6 6
  • 7. Hot Topic Challenge to the 11/1/07 USPTO Rules Tafas v. Dudas (aka the GSK case) 7
  • 8. Tafas vs. Dudas April 1, 2008: District Court for the Eastern district of Virginia issued a Permanent Injunction of the USPTO rules package that was to take effect November 1, 2007. (The USPTO is appealing) 8
  • 9. Tafas vs. Dudas “. . . The court finds that the Final Rules are substantive in nature and exceed the scope of the USPTO’s rulemaking authority. . . .” 9
  • 10. Tafas vs. Dudas Refresher: The November 1, 2007 Rules “2+1” Rule (Rule 78 + Rule 114) Only two continuations and 1 RCE as of right per family. “5/25” Rule (Rule 75) Only 5 independent and 25 total claims per appln. “ESD” (examination support document) Shifted examination burden onto applicant. 10
  • 11. Tafas vs. Dudas Two continuations (Rule 78) “Final rule 78 and the hard limit it imposes changes existing law and deprives applicants of their valuable rights . . . to an unlimited number of continuation and continuation-in-part applications as a matter of right. “ (emphasis added) “By so doing, it may also impact applicants’ rights under Sections 102 and 103 and result in the denial of otherwise meritorious patents. For these reasons, the Court finds that Final Rule 78 is a substantive rule.” 11
  • 12. Tafas vs. Dudas One Request for Continued Examination (Rule 114) “. . . Limiting RCEs based on application family is a clear departure from the plain language of the statute, which states that the USPTO must provide for the continued examination of each application.” [35 USC § 132(a) . . . if “the applicant persists in his claim for a patent . . . the application shall be reexamined.”] 12
  • 13. Tafas vs. Dudas 5/25 Claims Rule: Rule 75 “Since 1938, the CCPA has consistently held that the Patent Act does not place any mechanical limits on the number of claims an applicant may file.” 13
  • 14. Tafas vs. Dudas Options for the USPTO Appeal to the Federal Circuit (a brief statement of the issues is due June 18) Congress Modified Rule Package Where do we stand? “The battle for Helms Deep has been won. The battle for Middle Earth has begun.” (LOTR – TTT) 14
  • 15. Hot Topic Current USPTO Proposed Rulemakings Biological Deposits Information Disclosure Statements Alternative claims 15
  • 16. Biological Deposits Proposed Rulemaking: Biological Deposits “Revision to the Time for Filing of a Biological Deposit and the Date of Availability of a Biological Deposit” 73 Fed. Reg. 9254 (20 February 2008) (comments were due April 21, 2008) 16
  • 17. Biological Deposits (1) Any deposit of biological material must be made before publication of the patent application. (The deposit must be made before “technical preparations” for publication have begun. (37 C.F.R. § 1.804). i.e., about 4 months before the expected publication date.) (2) Depositor must agree that all restrictions to the access to the deposited material will be removed upon the earlier of publication or grant of the patent. 17
  • 18. Information Disclosure Statements (IDS) Proposed Rulemaking: IDS Practice “Changes To Information Disclosure Statement Requirements and Other Related Matters” 71 Fed. Reg. 38808 (10 July 2006) Status: A Paperwork Reduction Act challenge must be resolved before compliance can be required http://www.reginfo.gov/public/do/PRAViewDocument?ref _nbr=200707-0651-005 18
  • 19. IDS Practice IDS Requirements Four time periods of importance: (1) the later of 3 months after the filing date, or, the mailing of the first office action (2) after first office action but before allowance (3) after allowance but before issue fee payment (4) after issue fee payment 19
  • 20. Claims Containing “Alternative” Language Proposed Rulemaking: “Examination of Patent Applications That Include Claims Containing Alternative Language” 72 Fed. Reg. 44992 (10 August 2007) Republished 73 Fed. Reg. 12679 (10 March 2008) (comments were due April 8, 2008) 20
  • 21. Claims with Alternative Language Ground rules Applies to all technologies. – Permits the USPTO to “restrict“ the alternatives – from each other even within a claim 21
  • 22. Claims with Alternative Language An “alternative-type” claim is any claim that recites a plurality of alternatively usable members. The rulemaking is not limited to Markush groups. - Markush group: “selected from the group consisting of plastic, steel and paper” - Alternative language but not Markush group: “wherein the cup is made of plastic, steel or paper” 22
  • 23. Claims with Alternative Language Every claim would be required to be limited to a “single invention.” Note: A claim that encompasses more than one species, but does not list alternatives, defines one generic invention (but may still be subject to “election of species”). 23
  • 24. Claims with Alternative Language When is a claim having alternatives considered to be a single invention? (1) When all the species encompassed by the claim share a substantial feature essential for a common utility. or (2) When the alternatives are prima facie obvious over each other if there is prior art that renders at least one of the alternatives obvious. 24
  • 25. Claims with Alternative Language Examples (A) A series of DNA probes x, x’, x” that share sequence and that all bind the same species of virus. - the probes have common utility (B) A series of DNA probes x, y, z, that bind different strains of a single virus, for example, the influenza virus. - the probes do not have a common utility - the alternatives would be restrictable 25
  • 26. Claims with Alternative Language Possible admission? Each alternative within a list of alternatives must be substitutable one for another. (37 C.F.R. § 1.75 (j) (4)) 26
  • 27. Hot Topic Prosecution History Estoppel Hakim vs. Cannon Avent Group No. 05-1398, Federal Circuit (Michel, Newman, Rader) 27
  • 28. Hakim vs. Cannon Avent Group Hakim originally sued Avent in District Court (W.D. La.) asserting infringement of Hakim’s United States Patents by Avent’s leak- resistant drinking cups. 28
  • 29. Hakim vs. Cannon Avent Group The asserted patent was a continuation. In the parent, Hakim distinguished art by stating that the flexible-member opening was a quot;slit.quot; When the continuation was filed, Hakim notified the examiner that the new claims were broader than those previously allowed. The Examiner allowed the new claims without rejection. 29
  • 30. Hakim The District Court (trial court) relied on statements made during prosecution of a parent application to narrowly construe a claim term that was explicitly broadened in the child application. The court ruled that the applicant's efforts to disclaim the perceived estoppel were insufficient. Federal Circuit affirmed: Although a disclaimer made during prosecution can be rescinded, disclaimed scope, the prosecution history must be sufficiently permitting recapture of the clear to inform the examiner that the previous disclaimer, and the prior art that it was made to avoid, may need to be re-visited. 30
  • 31. After Hakim – Text to submit with continuing applications “The claims in the instant application are different than those of the parent application or other related applications. (a) The Applicant therefore rescinds any disclaimer of claim scope made in the parent application or any predecessor application in relation to the instant application. (b) The Examiner is therefore advised that any such previous disclaimer and the cited references that it was made to avoid, may need to be revisited. (c) Further, the Examiner is also reminded that any disclaimer made in the instant application should not be read into or against the parent application.” 31
  • 32. Practice Point If you have taken any positions in a parent application that you want to change in a child application, tell your US patent attorney to explicitly disclaim those positions. 32
  • 33. Hot Topic Reviving PCT National Stage Entries in the United States for Unintentional Abandonment Aristocrat Technologies Australia (ATA) v. International Gaming Technologies (IGT) (Fed. Cir. 2008 PENDING) 33
  • 34. Reviving PCT Nat’l Stage Entries Aristocrat missed its US national stage entry by 1 day. PTO granted a petition to revive for unintentional abandonment. Time passes. The patent issues and is litigated. District court found PTO lacked authority to revive unintentionally late national stage applications. 34
  • 35. Hot Topic Statutory Subject Matter In re Bilski (Fed. Cir. 2008, 07-1130 order) 35
  • 36. 35 U.S.C. § 101 Statutory subject matter In re Bilski - business method (method to manage risk) - implications for biotech diagnostics and treatment methods Q: Would biotech methods have to be tied to a machine or result in a physical transformation of an “object”? 36
  • 37. 35 U.S.C. § 101 Statutory subject matter A method for determining whether a patient will respond to drug X, said method comprising: (1) determining whether the sequence of said patient’s gene Y comprises haplotype Z, wherein …. (“determining” encompasses consulting the patient’s medical records) 37
  • 38. Hot Topic Inherency and Medical Treatments 38
  • 39. 35 U.S.C. § 102 (Novelty) Inherency Administration of peptide X is known to decrease blood sugar. Newly discovered: administration of peptide X strengthens fingernails. 39
  • 40. Hot Topic Obviousness after KSR KSR v. Teleflex, 550 U.S. ___, 127 S. Ct. 1727, 82 U.S.P.Q.2d 1385 (2007) 40
  • 41. The U.S. Standard of Obviousness After KSR Our firm was co- counsel to Teleflex at the Supreme Court argument 41
  • 42. KSR Supreme Court expressed “a need for caution” on granting a patent based on the combination of elements found in the prior art.” The “teaching/suggestion/motivation” rationale is just one that can be used to establish obviousness. 42
  • 43. KSR in a nutshell Where there is (a) A problem (b) And a finite number of identified, predictable solutions (c) And pursuing this problem leads to “anticipated” success… (d) Then finding a combination was obvious to try might show it was obvious under 103. 43
  • 44. Applying KSR in the courts Ex Parte Kubin 83 USPQ2d 1410 (BPAI 2007) (on appeal to Federal Circuit) An isolated nucleic acid molecule 73. 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. 44
  • 45. Applying KSR to Kubin Was there a problem? Were there a finite number of identified, predictable solutions? Did pursuing this problem leads to “anticipated” success? Then finding a combination was obvious to try might show it was obvious under 103. 45
  • 46. Applying KSR at the USPTO USPTO Obviousness Guidelines 72 Fed Reg. 57526 (October 10, 2007) http://www.uspto.gov/web/offices/com/sol/notices/72fr5 7526.pdf http://edocket.access.gpo.gov/2007/pdf/E7-19973.pdf 46
  • 47. PTO Obviousness Guidelines “The mere existence of differences between the prior art and an invention does not establish the invention’s nonobviousness.” Neither motivation nor the problem controls. 47
  • 48. PTO Guidelines – Rationales 1. Combining prior art elements according to known methods to yield predictable results. 2. Simple substitution of one known element for another. 3. Use of known technique to improve similar devices/methods/products the same way. 4. Applying known technique to known device/method/product ready for improvement to yield predictable results. 48
  • 49. PTO Guidelines – Rationales 5. Obvious to try – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success 6. Known work in one field of endeavor may prompt variations for use in the same field or a different field due to incentive based on its design or market forces. 7. TSM test: A teaching, suggestion or motivation in the prior art would have led the skilled artisan to the invention. 49
  • 50. What is required from the Examiner? An “articulated reasoning” Rejections on obviousness “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.” 50
  • 51. KSR Drafting Strategies Caution: Try not to make the “Background” of the invention a KSR roadmap by just stating the problem that the invention solved and that there was a need in the art. Can you characterize the problem solved as previously unrecognized or unappreciated? Can you use the background to set yourself up for future “teaching away” argument? Emphasize: obstacles; unpredictability; multiple ways to fail 51
  • 52. Hot Topic Written Description USPTO Revision to the Written Description Materials 52
  • 53. 35 U.S.C. § 112 USPTO Written Description Training Materials Revision 1 (March 25, 2008) http://www.uspto.gov/web/menu/written.pdf “Updates” 1999 training materials 53
  • 54. USPTO Written Description Training Materials: Revision 1 Major change from 1999 See examples 6 and 10 Functional language in a DNA or protein claim that recites a % homology/identity may render that claim invalid for lack of written description. 54
  • 55. Hot Topic Increasingly Activist Role of the USPTO Office of Enrollment and Discipline 55
  • 56. OED Hot Topic: USPTO Office of Enrollment and Discipline (OED) Administrative Initiatives OED Interpretation of Current Rules OED has stated in public meetings it intends to: quot;investigatequot; attorneys who file a quot;large numberquot; of references that quot;could be usedquot; to reject quot;a substantial numberquot; of the claims presented in an application. 56
  • 57. OED Hot Topic: OED View of the Ethical Duty of Practitioners Practitioners submitting papers must read each paper submitted to the Office before it is submitted. This includes each document submitted with an IDS. Each submitted document must be read in its entirety. Must read regardless of the source of the paper. 57
  • 58. OED Hot Topic: OED View of the Ethical Duty of Practitioners (1) Filing an application with a claim that is anticipated by one of the inventor's own publications could rise to a disciplinary matter. (2) Filing an application that, in the specification, refers to art that in combination establishes a claim is unpatentable could also rise to a disciplinary matter. 58
  • 59. Hot Topic USPTO Initiatives to Reduce Backlog 59
  • 60. USPTO Administrative Initiatives to Expedite Prosecution Patent Prosecution Highways Unified Application Format Interview Before First Office Action 60
  • 61. Practice Tip Interviews Prior to First Official Action A request for an interview prior to the first Office action is ordinarily granted in continuing . . . applications . . . the examiner may require that an applicant requesting an interview before the first Office action provide a paper that includes a general statement of the state of the art at the time of the invention, and an identification of no more than three (3) references believed to be the quot;closestquot; prior art and an explanation as to how the broadest claim distinguishes over such references. (MPEP 713.02) 61
  • 62. Practice Tip Interviews Prior to First Official Action in New Utility Application (pilot program) Limited to art units 2140 or 2150 (not biotech) Examiner conducts a prior art search Examiner provides applicant with a pre-interview communication that is a preview of objections or rejections. Applicant has 30 days to decide whether to interview or not. 62
  • 63. Practice Tip Interviews Prior to First Official Action in New Utility Application (pilot program) If applicant decides to have the interview: applicant all issues must be discussed If agreement is reached, a notice of allowance will be mailed. If agreement is not reached, applicant has the longer of 1 mo/30 days to reply to office action. If applicant decides not to have the interview: An office action will be mailed Applicant has the longer of 1 mo/30 days to reply. EOTs are limited. 63
  • 64. The Workshop 7 Scenarios: 1: Polymorphisms/haplotypes/scope of determining 2: New protein and its use; effect of art 3: Improvements/evergreening/design around 4: More improvements: inherency/publication/112(1) 5: More improvements: new use/inherency 6: Reach through claims: inventions not yet made 7: Patentable subject matter: In silico inventions 64
  • 65. Scenario 1A Human gene X, and its sequence, SEQ ID NO: 1, are known in the art. The inventors have found 8 single nucleotide PMs. PM 1-3 are associated with having condition X. PM 4-6 are not associated with having condition X. It is unknown if PM 7-8 are related to condition X. No other single nucleotide polymorphisms of SEQ ID No. 1 are known. 65
  • 66. Scenario 1A Claim 1. An isolated nucleic acid molecule comprising SEQ ID NO: 1 except for a single polymorphic change at one of the positions as shown in Table 1. 66
  • 67. Scenario 1A Claim 2. A method for detecting the presence of condition X in an individual, said method comprising: (a) isolating a nucleic acid from a sample that has been removed from said individual and (b) detecting the nucleotide present at one or more polymorphic sites within SEQ ID NO: 1 as listed in Table 1, wherein the presence of the nucleotide specified in Table 1 is indicative of the presence of said condition X. 67
  • 68. Scenario 1A – Unity? Patentable? PM Position Change Correlation 1 10 G Yes 2 27 A Yes 3 157 C Yes 4 234 T No 5 1528 G No 6 3498 C No 7 13524 T Unknown 8 14692 A Unknown 68
  • 69. Scenario 1B: Haplotypes Haplotypes are discovered that indicate whether a drug is effective in treating condition X. Each haplotype is a specific combination of 7 different polymorphic sites. Haplotype (1) is known in the art. Haplotypes (2-5) are novel. Efficacy is assoc with haplotypes (1) and (5). 69
  • 70. Scenario 1B: Unity? Patentable? Haplotype Correlation 1 Yes 2, 3 and 4 No 5 Yes *Rem: Haplotype (1) was known in the art but it was not known to be correlated with drug X efficacy. 70
  • 71. Scenario 1C: “Determining” Claim 3: A method for predicting whether an individual will respond to treatment with compound X, said method comprising (a) determining the presence or absence of haplotype (1) or (5) in the DNA of said individual; and (b) predicting the individual will respond to treatment with said compound X if said haplotype (1) or (5) is present in said DNA. Claim 4: The method of claim 4 in which said determining comprises consulting a medical record. 71
  • 72. Scenario 2A The inventors have discovered protein PPP and isolated it from I. gotcha membrane preparations. The inventors propose protein PPP is useful to elicit a protective immune response against I. gotcha infections. 72
  • 73. Scenario 2A Claim 1: A substantially pure I. gotcha protein, wherein said protein has a molecular weight of about 20 kDa and comprises the amino acid sequence [insert the 10 amino acid sequence], or a homolog, derivative, or immunogenic fragment of said I. gotcha protein. 73
  • 74. Scenario 2B Cited art: One art protein (SEQ ID No. 42312) contains the inventors' 10 amino acid sequence, but at an internal site (internal amino acids 5-14). The art’s specification contains generic teachings of how one would isolate any I. gotcha proteins, and generic disclosure of how one would use such a proteins as part of a protective vaccine for I. gotcha. This art is cited for novelty. The examiner also bases an obviousness rejection on the combination of LOTASEQ's publication and a scientific journal article that describes the use of crude membrane extracts of I. gotcha to elicit antibodies that will cross react with different I. gotcha serotypes. 74
  • 75. Scenario 2B Now how would you revise: Claim 1 (repeated below): A substantially pure I. gotcha protein, wherein said protein has a molecular weight of about 20 kDa and comprises the amino acid sequence [insert the 10 amino acid sequence], or a homolog, derivative, or immunogenic fragment of said I. gotcha protein. 75
  • 76. Scenario 3: Improvements (1) The protein vaccine can be provided for oral administration as a solid in food. (2) They have discovered that an equally good vaccine can be made using isolated naked DNA that encodes protein PPP in the vaccine preparation, instead of the protein itself. (3) RNAi can be used, in vitro, to inhibit growth of the bacteria. No additional art has been discovered 76
  • 77. Scenario 4: More Improvements: Effect of: Publication; 112 Support; Inherency issues A method of treating and/or preventing infection by I. gotcha, said method comprising inhibiting growth of I. gotcha by contacting said I. gotcha with an antibody or antigen binding portion thereof that binds to an epitope located within amino acids 155- 355 of Protein PPP. (a) Assume Scenarios 2 and 3 have published. (b) Assume Scenarios 2 and 3 have not yet published. (c) The inventors want to recite both quot;treatquot; and quot;prevent.quot; However, the first application only mentions quot;preventquot; (i.e., the protective vaccine). 77
  • 78. Scenario 5: More Improvements: More Inherency questions The inventors have discovered that the incidence of cataracts in patients who have been vaccinated against protein PPP is much lower than the general population. The inventors propose a method of preventing cataracts by vaccinating a subject with the I. gotcha protein PPP vaccine. Is inherency a problem? 78
  • 79. Scenario 6: The eye receptor The inventors have used the high homology between DNA encoding protein PPP and that encoding the eye receptor to clone and express the homologous eye receptor. A new application is filed directed to the new receptor and its expression in animal cells. The specification also has a general description of a series of screening procedures as recited in the claims below. However, there are no working examples in which agonists or antagonists of this receptor are identified. 79
  • 80. Scenario 6: The eye receptor: claims for discussion 1. An isolated and purified eye receptor the amino acid sequence of which consists of SEQ ID NO: 1. 2. A method of identifying an agonist of the receptor of claim 1, said method comprising: preparing a candidate compound, contacting a cell which expresses said receptor on its surface with said candidate compound; and determining whether said candidate compound activates the receptor of claim 1, wherein a compound that activates the receptor of claim 1 is an agonist of said receptor. 80
  • 81. Scenario 6: The eye receptor: claims for discussion 3. An isolated and purified receptor agonist identified by the method of claim 2. 4. A method for the prevention and treatment of a disease preventable and treatable by the agonist of claim 2, comprising administering to a host in need thereof a therapeutically effective amount of the agonist identified by the method of claim 2. 5. A monoclonal antibody which recognizes the receptor of claim 1. 81
  • 82. Scenario 7: Patentable subject matter Back up in time to Scenario 2. The inventors had just then discovered and isolated Protein PPP. It was a novel protein. Assume the original specification gives the atomic coordinates of protein PPP and asserts the coordinates are useful in in silico screening methods. 82
  • 83. Scenario 7: Patentable subject matter : claims for discussion Claim 1: A computer model of protein P generated with the atomic coordinates listed in Fig. 1. Claim 2: A data array comprising the atomic coordinates of protein P as set forth in Fig. 1 which, when acted upon by a protein modeling algorithm, yields a representation of the 3-D structure of protein P. Claim 3: A computer-readable storage medium encoded with the atomic coordinates of protein P as shown in Fig. 1. 83
  • 84. Scenario 7: Patentable subject matter: claims for discussion Claim 4: An isolated and purified protein having the structure defined by the structural coordinates as shown in Fig. 1. Claim 5: A crystalline form of protein PPP having unit cell dimensions of a=4.0 nm, b=7.8 nm and c=11.0 nm. Claim 6: An isolated and purified molecule comprising a binding pocket of protein PPP defined by the structural coordinates of amino acids 223, 224, 227 and 384 according to Figure 1. 84
  • 85. Scenario 7: Patentable subject matter: claims for discussion Claim 7: An isolated and purified polypeptide consisting of a portion of protein PPP starting at one of amino acids 214 to 218 and ending at one of amino acids 394 to 401 of protein P as set forth in SEQ ID NO: 1. Claim 8: A method of identifying a compound that can bind to protein PPP, comprising the steps of: (a) applying a 3-dimensional molecular modeling algorithm to the atomic coordinates of protein P to determine the spatial coordinates of the binding pocket of protein P shown in Fig. 1; and (b) electronically screening the stored spatial coordinates of as et of candidate compounds against the spatial coordinates of the protein P binding pocket to identify compounds that can bind to protein P. 85
  • 86. Scenario 7: Patentable subject matter: claims for discussion Claim 9: A method of identifying compounds that can bind to protein PPP by comparing the 3-D structure of candidate compounds with the 3-D molecular model shown in Fig. __ which comprises the steps of: . . . [specific steps are listed]. 86
  • 87. THANK YOU! Michele A. Cimbala, Esq. mcimbala@skgf.com 87 87

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