1. www.fitzpatrickcella.com Compliance with the Written Description Requirement FITZPATRICK, CELLA, HARPER & SCINTO 30 Rockefeller Plaza New York, NY Raymond R. Mandra, Esq. Partner

2. www.fitzpatrickcella.com 2 Compliance with the Written Description Requirement Look To: 35 U.S.C. §112, First Paragraph The Case Law The PTO Guidelines (And Training Materials)

3. www.fitzpatrickcella.com 3 Written Description Statute “The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.” (emphasis added) 35 U.S.C. § 112, ¶ 1

4. www.fitzpatrickcella.com 4 Written Description Basics An adequate written description means describing the invention in sufficient detail that one skilled in the art can conclude that the inventor invented the claimed invention. Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997). An adequate written description means describing the invention in sufficient detail so that one skilled in the art can conclude the inventor had possession of the claimed invention. Purdue Pharma L.P. v. Faulding Inc., 230 F.3d 1320, 1323 (Fed. Cir. 2000). Possession is shown by describing the invention with all its claim limitations, even if they are obvious, and is measured as of the filing date sought. Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1571-72 (Fed. Cir. 1997).

5. www.fitzpatrickcella.com 5 Written Description Basics Fact question – reviewed for clear error Meaningful and adequate disclosure is quid pro quo to public for being excluded from practicing the invention for limited period An “application itself must describe an invention, and do so in sufficient detail that one skilled in the art can clearly conclude that the inventor invented the claimed invention as of the filing date sought.” Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 U.S.P.Q.2d 1961, 1966 (Fed. Cir. 1997)

6. www.fitzpatrickcella.com 6 Written Description v. Enablement Written description means describing the invention in sufficient detail that one skilled in the art can conclude that the inventor invented the claimed invention Enablement means one skilled in the art is taught by the patent how to make and use the invention, without undue experimentation

7. www.fitzpatrickcella.com 7 Some Relevant Cases Written description  In re Ruschig, 379 F.2d 990 (C.C.P.A. 1967).  The Regents of California v. Eli Lilly & Co., 119 F.3d 1559 (Fed. Cir. 1997)  Gentry Gallery v. Berkline Corp., 134 F.3d 1473 (Fed. Cir. 1998)  Enzo Biochem, Inc. v. Gen-Probe Inc., 285 F.3d 1013 (Fed. Cir. 2002)  Enzo Biochem, Inc. v. Gen-Probe Inc., 296 F.3d 1316 (Fed. Cir. 2002)  University of Rochester v. G.D. Searle & Co., 2003 U.S. Dist. LEXIS 3030 (W.D.N.Y. 2003)  Moba, B.V. v. Diamond Automatic, 325 F.3d 1306 (Fed. Cir. 2003)

8. www.fitzpatrickcella.com 8 Written Description Basics Often applied to a priority situation, e.g., new matter added However, the written description requirement also applies to original claims. The Regents of the University of California v. Eli Lilly and Co., 119 F.3d 1559 (Fed. Cir. 1997)

9. www.fitzpatrickcella.com 9 Lilly Facts Patent specification disclosed: –rat insulin cDNA sequences –method for obtaining them –amino acid sequences of human insulin Claims in dispute were to vertebrate, mammalian and human insulin cDNA

10. www.fitzpatrickcella.com 10 Lilly Holdings Human cDNA claims: patent describes only general method for obtaining human insulin-encoding cDNA, but not cDNA’s relevant structural or physical characteristics description of human insulin amino acid sequences does not describe cDNA that encodes them (because of redundancy of genetic code) Court affirmed judgment that both human cDNA and genus cDNA patent claims were invalid for lack of written description:

11. www.fitzpatrickcella.com 11 Lilly Holdings (continued) Genus cDNA claims: disclosure of rat cDNA sequences does not describe structure of sufficient members of broad “functional” classes of “vertebrate” or mammalian” insulin cDNA “A definition by function… does not suffice to define the genus because it is only an indication of what the gene does, rather than what it is” Lilly, 119 F.3d at 1568

12. www.fitzpatrickcella.com 12 Lilly Consequences How should one properly describe cDNA genus? According to Lilly : One way is to recite the nucleotide sequences of a representative number of cDNAs (silent as to what is representative) Another way is to recite structural features common to genus members, which features constitute a substantial portion of genus Lilly, 119 F.3d at 1569

13. www.fitzpatrickcella.com 13 Gentry Gallery The patent disclosed that recliner controls were located on the console of a sectional sofa having two independent recliner seats facing in the same direction Broadest claim covered control means mounted on the double reclining seat sofa section The court concluded that the patent did not support claims where the recliner controls were not located on the console since that location was an essential element of the invention when viewing the disclosure in its entirety

14. www.fitzpatrickcella.com 14 Enzo Facts Detection of bacteria that causes gonorrhea difficult because of high degree of homology between N. gonorrhoeae and meningitidis Specification referred to ATCC deposit of three sequences that preferentially hybridize to six common strains of N. gonorrhoeae over six common strains of N. meningitidis (also deposited) Enzo Bichem, Inc. v. Gen-Probe Inc., 296 F.3d 1316 (Fed. Cir. 2002)

15. www.fitzpatrickcella.com 15 Enzo Facts (continued) Patent claims nucleotide sequence that preferentially hybridizes to N. gonorrhoeae over N. meningitidis by ratio of greater than 5:1 Dependent claims were drawn to the three deposited probe sequences and discrete subsequences, mutations, and mixtures

16. www.fitzpatrickcella.com 16 Enzo Procedural Background Original panel decision (Lourie; Prost; Dyk, dissenting) affirmed judgment claims were invalid for failure to meet written description requirement of 35 U.S.C. § 112 rejected argument that deposit inherently disclosed inventors were in possession of claimed sequences On rehearing, panel unanimously vacated that decision and reversed and remanded

17. www.fitzpatrickcella.com 17 Enzo Holdings On rehearing, Court faced with two main questions: 1.Whether Enzo’s deposits of claimed sequences of dependent claims constituted an adequate written description? Issue of first impression Reference in specification to a deposit in a public depository, when it is not otherwise available in written form, may constitute an adequate written description Remanded - fact issue of whether subsequences, mutations, and mixtures were described by reference to the deposited sequences Enzo, 296 F.3d at 1325

18. www.fitzpatrickcella.com 18 Enzo Holdings (cont’d.) 2.Whether written description requirement is met for all claims on basis of functional ability of three deposited probe sequences to hybridize to deposited strains of N. gonorrhoeae? Depends on whether three deposited sequences are representative of the scope of the genus under Lilly PTO written description Training Example 9 provides that nucleic acid genus claims may be adequately described if nucleic acids hybridize under highly stringent conditions to known sequences Remanded issue to be decided consistent with Lilly and PTO’s written description Guidelines Enzo, 296 F.3d at 1324, 1327-28

19. www.fitzpatrickcella.com 19 Enzo Additional Issues 1.Whether reference to deposit of six strains of N. gonorrhoeae inherently describes claimed sequences that hybridize to them (i.e., by showing function/structure correlation) is a fact issue 2.Ipsis verbis inclusion of claim words in specification does not necessarily satisfy the written description requirement, e.g., an “anti-inflammatory steroid” or an “antibiotic penicillin”

20. www.fitzpatrickcella.com 20 Enzo Additional Issues 3.Even if three deposited probe sequences indicated Enzo “possessed” invention, “possession” may not be sufficient to describe invention — compare Lockwood, “One shows that one is ‘in possession’ of the invention by describing the invention, with all its claimed limitations, not that which makes it obvious.” Lockwood 107 F.3d at 1572, emphasis omitted 4.Reduction to practice without adequate description is insufficient to describe invention

21. www.fitzpatrickcella.com 21 Enzo En Banc Rehearing Denial Only Rader, Gajarsa and Linn voted for rehearing (PTO filed brief as amicus in favor of rehearing) Dyk, who voted against rehearing, nevertheless said Court would benefit from “further percolation” of the issues Enzo Biochem, Inc. v. Gen-Probe Inc., 42 Fed. Appx. 439 (Fed. Cir. 2002)

22. www.fitzpatrickcella.com 22 Enzo En Banc Rehearing Denial Those for en banc rehearing: based on statute, there is no separate written description requirement; only an enablement requirement separate written description requirement introduced by CCPA in 1967 only for determining priority Lilly was first CAFC case to apply written description outside of a priority context Lilly and Enzo result in heightened disclosure requirement making enablement irrelevant

23. www.fitzpatrickcella.com 23 Enzo En Banc Rehearing Denial Those against en banc rehearing: Written description is separate requirement from enablement Statute says “and” between mentions of written description and enablement Supreme Court in Festo said “patent application must describe, enable and set forth the best mode of carrying out the invention” Fact that prior written description cases may have dealt only with priority is circumstantial

24. www.fitzpatrickcella.com 24 Post-Enzo Written Description Decisions University of Rochester v. G.D. Searle & Co., 2003 U.S. Dist. LEXIS (W.D.N.Y. 2003). Moba B.V. v. Diamond Automatic, 325 F.3d 1306 (Fed. Cir. 2003).

25. www.fitzpatrickcella.com 25 Searle Facts Cox-1 helps protect stomach lining Cox-2 associated with inflammation stimuli Prior art drugs (NSAID’s) inhibited both Cox-2 and Cox-1

26. www.fitzpatrickcella.com 26 University of Rochester claim 1: 1.A method for selecting inhibiting PgHS-2 activity in a human host, comprising administering a non-steroidal compound that selectively inhibits activity of the PGHS-2 gene product to a human host in need of such treatment.

27. www.fitzpatrickcella.com 27 Searle Facts (continued) Patent describes screening assays useful for development of drugs that selectively inhibit inflammation without producing side effects due to inhibition of Cox-1 Patent says assays are for screening compounds including peptides, polynucleotides and small organic molecules Patent claims method of administering to humans a non-steroidal compound that selectively inhibits Cox-2 activity and has minimal effect on Cox-1 activity

28. www.fitzpatrickcella.com 28 Searle Holding Court held (Larimer, J.) patent failed to provide written description of claimed invention: patent only describes the function of compound called for but no showing of correlation between function and structure (relying on PTO written description Guidelines) inventors did not identify even one suitable compound patent is merely “research plan” that describes tests to run on wide spectrum of compounds in hope at least one will work Court rejected plaintiff’s contention that Enzo and Lilly limited to claims directed to nucleic acid sequences: Lilly ’s holding that the inventors must adequately describe invention is not limited to genetic material

29. www.fitzpatrickcella.com 29 Searle Additional Issues Court rejected plaintiff’s argument that written description requirement doesn’t apply to method of treatment claims: claimed method depends upon finding a compound that selectively inhibits COX-2 “It means little to invent a method if one does not have possession of the substance that is essential to practicing that method” University of Rochester, 2003 U.S. Dist. LEXIS 3030 at *31.

30. www.fitzpatrickcella.com 30 Moba Patent claimed a method of processing eggs The alleged infringer argued that since the court had construed the patent claim at issue to encompass lifting eggs from a moving conveyor, then the claim must be invalid for lack of written description because the specification did not disclose any such conveyor mechanisms

31. www.fitzpatrickcella.com 31 Moba (continued) Per curium (Judges Rader, Schall and Bryson) “The test for compliance with § 112 has always required sufficient information in the original disclosure to show that the inventor possessed the invention at the time of the original filing.”

32. www.fitzpatrickcella.com 32 Moba Holdings Gentry Gallery was not controlling because there was no allegation that the patent disclosure did not show possession of a later-filed claim. The “Lilly disclosure rule” was not applicable because one skilled in the art could determine from the as-filed specification that the inventor possessed the invention.

33. www.fitzpatrickcella.com 33 Moba (Judge Rader concurring) it is a mistake to apply the written description doctrine beyond priority The “Lilly rule” requires the nucleotide by nucleotide recitation of an entire sequence and this rule unnecessarily increases the cost and time required to prepare and prosecute a biotech application to enable is to show possession and to show possession is to enable the Lilly rule requires en banc correction.

34. www.fitzpatrickcella.com 34 Moba (Judge Bryson concurring) Does not believe you can separate Lilly from In re Ruschig based on priority because § 112, first paragraph, makes no such distinction. Are the Ruschig line of cases based on a flawed construction of 35 USC § 112, first paragraph?

35. www.fitzpatrickcella.com 35 Status of Written Description Requirement Genus may be adequately described by identifying sufficient number of species or structural features common to substantial portion of genus ( Lilly ) Functional descriptions are not enough unless there is shown a clear correlation between function and structure ( Enzo ) Written description requirement applies to pharmaceuticals, nucleic acids, methods of treatment, and compositions ( Searle ) PTO Written Description Guidelines are important reference for prosecutors, opinion givers and litigators ( Enzo/Searle )

36. www.fitzpatrickcella.com 36 The PTO Written Description Guidelines –66 Fed. Reg. 1099, 1104 (Jan. 5, 2001) –Purpose is to assist the PTO in the examination of patent applications for compliance with the written description requirement –Do not constitute substantive rulemaking (perceived failure to follow neither appealable or petitionable) –Synopsis of Application of Written Description Guidelines available at http://www.uspto.gov/web/patents/guides.htm

37. www.fitzpatrickcella.com 37 Written Description Guidelines I.General Principals “The written description requirement of the Patent Act promotes the progress of the useful arts by ensuring that patentees adequately describe their inventions in their patent specifications in exchange for the right to exclude others from practicing the invention for the duration of the patent term.” 66 Fed. Reg. at 1104

38. www.fitzpatrickcella.com 38 Written Description Guidelines I.General Principals (continued) An applicant shows possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention. Possession may be shown in a variety of ways including description of an actual reduction to practice, or by showing that the invention was “ready for patenting” such as by the disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the applicant was in possession of the claimed invention. 66 Fed. Reg. at 1104

39. www.fitzpatrickcella.com 39 Written Description Guidelines I.General Principals (continued) The issue of an adequate written description may arise when –an original claim is not described sufficiently –a new or amended claim which adds or removes a limitation –a claim to benefit of an earlier priority date or effective filing date 66 Fed. Reg. at 1104

40. www.fitzpatrickcella.com 40 Written Description Guidelines I.A. Original Claims –strong presumption of adequate written description for an original claim –but, originally claimed invention “may not be adequately described if the claims require an essential or critical feature which is not adequately described in the specification and which is not conventional in the art or known to one of ordinary skill in the art.” (emphasis added) 66 Fed. Reg. at 1105

41. www.fitzpatrickcella.com 41 Written Description Guidelines I.B. New or Amended Claims –“New or amended claims which introduce elements or limitations which are not supported by the as-filed disclosure violate the written description requirement.” –Support must be either express, implicit or inherent 66 Fed. Reg. at 1105

42. www.fitzpatrickcella.com 42 Written Description Guidelines I.B. New or Amended Claims (continued) –obvious errors may be corrected if one skilled in the art recognizes (i) the existence of the error and (ii) the appropriate correction –deposits made after the filing date cannot support additions to or correction of information in the as- filed application. 66 Fed. Reg. at 1105

43. www.fitzpatrickcella.com 43 Written Description Guidelines I.B. New or Amended Claims (continued) –omission of a limitation may raise an issue; did the inventor have possession of a broader, more generic invention? –a claim that omits an element which applicant describes as an essential or critical feature of the invention originally disclosed does not comply with the written description requirement. 66 Fed. Reg.at 1105

44. www.fitzpatrickcella.com 44 Written Description Guidelines II.Methodology A.Read and Analyze the Specification (question of fact determined on a case-by-case basis) 1.For each claim determine what the claim as a whole covers. 2.Review the entire application to understand how applicant provides support for the claimed invention including each element and/or step. 3.Determine whether there is sufficient written description to inform a skilled artisan that applicant was in possession of the claimed invention as a whole at the time the application was filed. 66 Fed. Reg. at 1105

45. www.fitzpatrickcella.com 45 Written Description Guidelines II.Methodology (continued) a)Original Claims – possession may be shown by: i.actual reduction to practice (but see Enzo); ii.detailed drawings; iii.structural chemical formula; or iv.sufficient relevant, identifying characteristics from which a person skilled in the art would recognize that the inventor had possession. 66 Fed. Reg. at 1105-06

46. www.fitzpatrickcella.com 46 Written Description Guidelines II.Methodology (continued) For a single species or embodiment, the Examiner is to determine if an actual reduction to practice, detailed drawings or structural chemical formula shows possession of the claimed invention. If not, are there sufficient relevant, identifying characteristics? –if the complete structure (or acts of a process) is disclosed then adequate description. –if not, are there other relevant identifying characteristics sufficient to adequately describe the invention? 66 Fed. Reg. at 1106

47. www.fitzpatrickcella.com 47 Written Description Guidelines II.Methodology (continued) –Features for determining if other relevant identifying characteristics are sufficient *level of skill and knowledge in the art *partial structure *physical and/or chemical properties *functional characteristics alone or coupled with a known or disclosed correlation between structure and functions *method of making the claimed invention 66 Fed. Reg. at 1106

48. www.fitzpatrickcella.com 48 Written Description Guidelines II.Methodology (continued) –if the technology is mature and the level of skill is high then disclosure even of only a method of making and a function should be adequate to support a product claim –if the technology is emerging or unpredictable greater evidence is needed to show possession 66 Fed. Reg. at 1106

49. www.fitzpatrickcella.com 49 Written Description Guidelines II.Methodology (continued) –The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species, i.e., the species which are adequately described are representative of the entire genus. –the higher the skill and the knowledge in the art the smaller the representative number of species needed. –the more unpredictable the art the greater the representative number of species needed. 66 Fed. Reg. at 1106

50. www.fitzpatrickcella.com 50 Written Description Guidelines II.Methodology (continued) –New claims, amended claims or claims asserting a priority benefit must be expressly, implicitly, or inherently supported by the original application. –If the original application does not support the new claim limitation or if element described as essential or critical is missing from the claim, then lack of adequate written description. 66 Fed. Reg. at 1107

51. www.fitzpatrickcella.com 51 Some Suggestions Avoid unsupported provisos to obtain allowance If an element of the invention is described as critical or essential then it should be included in the claims When drafting an application be certain that the elements of your invention are accurately described Consider describing an alternative embodiment with the phrase “consisting essentially of” in the specification When drafting a provisional remember that the disclosure must meet the requirements of 35 U.S.C. § 112, first paragraph

52. www.fitzpatrickcella.com 52 Suggestions For Biotech Claims CLAIM THE HUMAN SEQUENCES (cDNA, GENOMIC, AMINO ACID) SPECIFICALLY FOR EXAMPLE SEQ ID NO: 1 = cDNA SEQ ID NO: 2 = GENOMIC SEQ ID NO: 3 = AMINO ACID (Perhaps active fragments of this protein) CLAIM cDNA (SEQ ID NO: 1) OPERABLY LINKED TO AN EXPRESSION CONTROL SEQUENCE CLAIM HOST CELL CONTAINING “OPERABLY LINKED” cDNA

53. www.fitzpatrickcella.com 53 Suggestions For Biotech Claims (continued) CLAIM NUCLEIC ACIDS THAT SPECIFICALLY HYBRIDIZE TO SEQ ID NOs:1 AND 2 UNDER HIGHLY STRIGENT CONDITIONS [and identify highly stringent conditions in specification or claim] CLAIM ANTISENSE NUCLEOTIDES THAT INHIBIT THE EXPRESSION OF SEQ ID NOs: 1 AND 2 CLAIM ANTIBODIES THAT BIND TO THE PROTEIN (SEQ ID NO: 3) CLAIM TRANSGENIC and/or KNOCKOUT ANIMALS (based on SEQ ID NOs: 1 AND 2)

54. www.fitzpatrickcella.com 54 Suggestions For Biotech Claims (continued) IF AWARE OF PARTICULAR FUNCTIONAL DOMAINS OR CONSERVED SEQUENCES, CLAIM THEM SPECIFICALLY [Amino Acid and Nucleotide sequence] CLAIM ANALOGS (SHOULD BE TIED TO FUNCTION OR OTHER DISTINGUISHING ATTRIBUTES, e.g., degeneracy of condons for SEQ ID NO: 3) CLAIM ALLELIC VARIANTS -- as possible support, discuss single nucleotide polymorphisms (SNPs) - (identify fact that some particular number of SNPs within the gene is known (e.g., in the public SNP database(s)); specifically identify those SNPs present within the coding sequence)

55. www.fitzpatrickcella.com Thank You