Written Description Analysis and Capon v. Eshhar

1. 1 Written Description Analysis and Capon v. Eshhar Jeffrey Siew Supervisory Patent Examiner AU 1645 USPTO (571) 272-0787 Jeffrey.Siew@uspto.gov

2. 2 35 U.S.C. 112 first paragraph 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. The most important terms in this statue are underlined. It should be noted that the test for an adequate written description is separate and distinct from the test under the enablement criteria of 35 USC 112 first paragraph. The absence of definitions or details for well-established terms or procedures should not be the basis for a rejection under 35 USC 112 paragraph 1, for lack of adequate written description. The most important terms in this statue are underlined. It should be noted that the test for an adequate written description is separate and distinct from the test under the enablement criteria of 35 USC 112 first paragraph. The absence of definitions or details for well-established terms or procedures should not be the basis for a rejection under 35 USC 112 paragraph 1, for lack of adequate written description.

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4. 4 General Principles Basic inquiry: Can one skilled in the art reasonably conclude that the inventor was in possession of the claimed invention at the time the application was filed? Written description requirement is separate and distinct from the enablement requirement

5. 5 Analysis If a skilled artisan would have understood the inventor to be in possession of the claimed invention at the time of filing, even if every nuance of the claim is not explicitly described in the specification, then the requirement for an adequate written description is met.

6. 6 Examples of Acceptable Showings of Possession Actual reduction to practice Reduction to practice normally not required Deposit of biological materials Clear depiction of the claimed invention in detailed drawings What is conventional or well known to one skilled in the art need not be disclosed in detail cf.: Amgen Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200, 18 USPQ2d 1016 (Fed. Cir. 1991) A deposit is not a substitute for written description Per 37 CFR 1.809(d), the specification must include a description of the deposit sufficient to specifically identify it and to permit examination. Clear depiction of the claimed invention in detailed drawings Pfaff v. Wells Electronics, Inc., 525 U.S. 55, 48 USPQ2d 1641 (1998) Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 19 USPQ2d 1111 (Fed. Cir. 1991) What is conventional or well known to one skilled in the art need not be disclosed in detail In re Hayes Microcomputer Products, Inc. Patent Litigation, 982 F.2d 1527, 1534-35, 25 USPQ2d 1241, 1246 (Fed. Cir. 1992) (�Disclosing a microprocessor capable of performing certain functions is sufficient to satisfy the requirement of section 112, first paragraph, when one skilled in the relevant art would understand what is intended and know how to carry it out.�). cf.: Amgen Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200, 18 USPQ2d 1016 (Fed. Cir. 1991) A deposit is not a substitute for written description Per 37 CFR 1.809(d), the specification must include a description of the deposit sufficient to specifically identify it and to permit examination. Clear depiction of the claimed invention in detailed drawings Pfaff v. Wells Electronics, Inc., 525 U.S. 55, 48 USPQ2d 1641 (1998) Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 19 USPQ2d 1111 (Fed. Cir. 1991) What is conventional or well known to one skilled in the art need not be disclosed in detail In re Hayes Microcomputer Products, Inc. Patent Litigation, 982 F.2d 1527, 1534-35, 25 USPQ2d 1241, 1246 (Fed. Cir. 1992) (�Disclosing a microprocessor capable of performing certain functions is sufficient to satisfy the requirement of section 112, first paragraph, when one skilled in the relevant art would understand what is intended and know how to carry it out.�).

7. 7 Evidence of Possession Written description describing sufficient relevant identifying characteristics Weigh factual considerations in view of level of skill and knowledge in the art The less mature the technology, the more evidence is required to show possession Level of skill and knowledge in the art increases over time Weigh factual considerations in view of level of skill and knowledge in the art See, e.g., Union Oil Co. of Cal. v. Atlantic Richfield (�In sum, the record shows that the inventors possessed the claimed invention at the time of filing in the assessment of those of ordinary skill in the petroleum refining art.�). Weigh factual considerations in view of level of skill and knowledge in the art See, e.g., Union Oil Co. of Cal. v. Atlantic Richfield (�In sum, the record shows that the inventors possessed the claimed invention at the time of filing in the assessment of those of ordinary skill in the petroleum refining art.�).

8. 8 Evidence of Possession Sufficient distinguishing identifying characteristics Weigh factual considerations in view of level of skill and knowledge in the art Complete or partial structure Physical and/or chemical properties Functional characteristics Correlation between structure and function Method of making Combinations of the above

9. 9 Capon v. Eshar, 418 F.3d 1349 (Fed. Cir. 2005) Claims directed to chimeric genes made from known DNA sequences of known functions using known procedures The Board found that �persons having ordinary skill would not have been able to visualize and recognize the identity of the claimed genetic material without considering additional knowledge in the art, performing additional experimentation, and testing to confirm results�. On example of Case law that addresses written description is the interference case of Capon v. Eshhar. Both Capon and Eshhar�s Both parties appealed the decision of the Board of Patent Appeals and Interference of the USPTO: the Board held that the specification of neither party met the written description act. The Board dissolved the interference and cancelled all of the claims of both parties corresponding to the interference count. Board authorized to determine priority of invention and redetermine patentability. Board invalidated all of the claims that had been designated as corresponding to the count if the interference: - all of the claims of Capon �221 patent - claims 5-8 of the Capon �046 parent patent claims 1-7, 9-20, and 23 of the Eshhar �994 application. The invention: -Invention allows the immune cells with antibody-type specificity, by combing known antigen-binding-domain producing DNA and known lymphocytes- receptor-protein producing DNA into a unitary gene that can express a unitary polypeptide chain. -Selected DNA segments of nonendogenous (encodes the single-chain variable (�scFv�) domain of an antibody) and endogenous (encodes cytoplasmic, transmembrane, and extracellular domains of a lymphocyte signaling protein) segments to a cell of the immune system. On example of Case law that addresses written description is the interference case of Capon v. Eshhar. Both Capon and Eshhar�s Both parties appealed the decision of the Board of Patent Appeals and Interference of the USPTO: the Board held that the specification of neither party met the written description act. The Board dissolved the interference and cancelled all of the claims of both parties corresponding to the interference count. Board authorized to determine priority of invention and redetermine patentability. Board invalidated all of the claims that had been designated as corresponding to the count if the interference: - all of the claims of Capon �221 patent - claims 5-8 of the Capon �046 parent patent claims 1-7, 9-20, and 23 of the Eshhar �994 application. The invention: -Invention allows the immune cells with antibody-type specificity, by combing known antigen-binding-domain producing DNA and known lymphocytes- receptor-protein producing DNA into a unitary gene that can express a unitary polypeptide chain. -Selected DNA segments of nonendogenous (encodes the single-chain variable (�scFv�) domain of an antibody) and endogenous (encodes cytoplasmic, transmembrane, and extracellular domains of a lymphocyte signaling protein) segments to a cell of the immune system.

10. 10 Capon (cont.) The Capon court reversed, explaining: Descriptive text needed �. varies with the nature and scope of the invention at issue, and with the scientific and technologic knowledge already in existence� �the written description requirement states that the patentee must describe the invention; it does not state that every invention must be described in the same way�. �as each field evolves, the balance also evolves between what is known and what is added by each inventive contribution� On example of Case law that addresses written utility is the Capon v. Eshhar case. Both parties to a patent interference proceeding have appealed the decision of the Board of Patent Appeals and Interference of the United States Patent and Trademark Office. The Board held that the specification of neither party met the written description requirements of the patent statue (patent interference is an administrative proceeding pursuant to 35 USC 102 and 135(a), conducted for the purpose of determining which of competing applicants is the first inventor of common subject matter). Board Decision: -Presumed enablement by the specification of �221 patent and �994 application of the full scope of their claims, therefore, decision based solely on the grounds of failure of written description. -The Board held neither party�s specification provides the requisite description of the full scope of the chimeric DNA or encoded proteins, by reference to knowledge in the art of the �structure, formula, chemical name, or physical properties� of the DNA or the proteins. Fed Cir Decision: -The �written description� requirement states that the patentee must describe the invention; it does not state that every invention must be described in the same way. -As the field evolves, the balance also evolves between what is known and what is added by each inventive contribution -The Board did not discuss the evidence with respect to the generality of the invention and the significance of the specific examples, instead simply rejecting all the claims for lack of a complete chimeric DNA sequence. -In summary, the Board erred in ruling that �112 imposed a per se rule requiring recitation in the specification of the nucleotide sequence of claimed DNA, when that sequence is already known in the field. -The case was vacated and remanded for appropriate further proceedings. On example of Case law that addresses written utility is the Capon v. Eshhar case. Both parties to a patent interference proceeding have appealed the decision of the Board of Patent Appeals and Interference of the United States Patent and Trademark Office. The Board held that the specification of neither party met the written description requirements of the patent statue (patent interference is an administrative proceeding pursuant to 35 USC 102 and 135(a), conducted for the purpose of determining which of competing applicants is the first inventor of common subject matter). Board Decision: -Presumed enablement by the specification of �221 patent and �994 application of the full scope of their claims, therefore, decision based solely on the grounds of failure of written description. -The Board held neither party�s specification provides the requisite description of the full scope of the chimeric DNA or encoded proteins, by reference to knowledge in the art of the �structure, formula, chemical name, or physical properties� of the DNA or the proteins. Fed Cir Decision: -The �written description� requirement states that the patentee must describe the invention; it does not state that every invention must be described in the same way. -As the field evolves, the balance also evolves between what is known and what is added by each inventive contribution -The Board did not discuss the evidence with respect to the generality of the invention and the significance of the specific examples, instead simply rejecting all the claims for lack of a complete chimeric DNA sequence. -In summary, the Board erred in ruling that �112 imposed a per se rule requiring recitation in the specification of the nucleotide sequence of claimed DNA, when that sequence is already known in the field. -The case was vacated and remanded for appropriate further proceedings.

11. 11 Written DescriptionSupport of claims Determination of what is needed to support generic claims to biological subject matter: Existing knowledge in the particular field Extent and content of the prior art Maturity of the science or technology Predictability of the aspect at issue Other considerations appropriate to the subject matter. Precedent illustrates that the determination of what is needed to support generic claims to biological subject matter depends on a variety of factors, such as the existing knowledge in the particular field, the extent and content of th prior art, the maturity of the science ir technology, the predictability of the aspect at issue, and other considerations appropriate to the subject matter. Precedent illustrates that the determination of what is needed to support generic claims to biological subject matter depends on a variety of factors, such as the existing knowledge in the particular field, the extent and content of th prior art, the maturity of the science ir technology, the predictability of the aspect at issue, and other considerations appropriate to the subject matter.

12. 12 35 USC �112, 1st Paragraph Example 1

13. 13 The Typical Reach-through Situation Consider the following claim: A therapeutic compound for inhibiting cancer growth in a mammal, said compound being capable of binding to UPINCANCER polypeptide.

14. 14 The Specification Discloses: Isolated UPINCANCER polypeptide comprising SEQ ID NO: 1. UPINCANCER polypeptide is highly over-expressed in malignant tissues. No compounds have been identified which bind to UPINCANCER and inhibit cancer cell growth. No structures of compounds which would predictably bind UPINCANCER and inhibit cancer cell growth are taught. The effect of compound binding to UPINCANCER on cancer cell growth has not been demonstrated.

15. 15 35 U.S.C.112 First Paragraph Conclusions The claim lacks written description for the compounds encompassed The claim is also not enabled for how to make the compound. The claim is not enabled for how to use the compound because it is unpredictable that binding to the polypeptide would inhibit cancer cell growth. Without some time of structural information predictive of a desired function, there is no way to predict what compounds would reasonably be expected to have the desired function and the amount of experimentation is undue. Further, while UPINCANCER has been correlated to cancer, the function is not known. While the identification of compounds that bind to UPINJCANCER may have a specific and substantial utility, for example in detecting increased levels of UPINCANCER, the compounds identified are not predictably enabled for treating cancer. Applicant was not in possession of any compounds, nor any information regarding the structures or functions of the compounds.Without some time of structural information predictive of a desired function, there is no way to predict what compounds would reasonably be expected to have the desired function and the amount of experimentation is undue. Further, while UPINCANCER has been correlated to cancer, the function is not known. While the identification of compounds that bind to UPINJCANCER may have a specific and substantial utility, for example in detecting increased levels of UPINCANCER, the compounds identified are not predictably enabled for treating cancer. Applicant was not in possession of any compounds, nor any information regarding the structures or functions of the compounds.

16. 16 Consider the following claim A method of treating a tumor by administering a Tamal peptide that is bound to a blood brain permeable group

17. 17 The specification discloses Tamal peptide is SEQ ID NO:2 Tamal peptide targets brain tumors. However, the peptide by itself cannot cross the blood brain barrier alone. The specification has tested only two chemicals that act as blood brain permeable groups when attached to Tamal peptide allows crossing the barrier. The chemicals do not have common structure. The specification then cites a laundry list of blood brain barrier groups including OH groups, phenols, polar groups such as polysaccharides amino acids

18. 18 35 U.S.C.112 First Paragraph Conclusions The claim lacks written description for the compounds encompassed Without some time of structural information predictive of a desired function, there is no way to predict what compounds would reasonably be expected to have the desired function and the amount of experimentation is undue. Further, while UPINCANCER has been correlated to cancer, the function is not known. While the identification of compounds that bind to UPINJCANCER may have a specific and substantial utility, for example in detecting increased levels of UPINCANCER, the compounds identified are not predictably enabled for treating cancer. Applicant was not in possession of any compounds, nor any information regarding the structures or functions of the compounds.Without some time of structural information predictive of a desired function, there is no way to predict what compounds would reasonably be expected to have the desired function and the amount of experimentation is undue. Further, while UPINCANCER has been correlated to cancer, the function is not known. While the identification of compounds that bind to UPINJCANCER may have a specific and substantial utility, for example in detecting increased levels of UPINCANCER, the compounds identified are not predictably enabled for treating cancer. Applicant was not in possession of any compounds, nor any information regarding the structures or functions of the compounds.

19. 19 THANK YOU! Jeffrey Siew Supervisory Patent Examiner AU 1642 USPTO (571) 272-0787 Jeffrey.Siew@uspto.gov