1 Written Description Analysis and Capon v. Eshhar Jeffrey Siew Supervisory Patent Examiner AU 1645 USPTO (571)

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.

3 Written Description Guidelines Federal Register –( –Written Description Guidelines 66 FR 1099 (January 5, 2001) Applies to all pending applications

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 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 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

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

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 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”.

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”

11 Written Description Support 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.

12 35 USC §112, 1st Paragraph Example 1

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 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 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.

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 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 35 U.S.C.112 First Paragraph Conclusions The claim lacks written description for the compounds encompassed

19 THANK YOU! Jeffrey Siew Supervisory Patent Examiner AU 1642 USPTO (571)