DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-16, 25-26, 35, and 42-44 are pending and under consideration.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. 15/598,356, filed on 5/18/2017. The instant application is a DIV of US Appl. No. 16/871,382 filed on 5/11/2020.
Information Disclosure Statement
The Information Disclosure Statement filed on 2/26/2024 has been considered.
Claim Objections
Claims 14 and 42 are objected to because of the following informalities: the examiner suggests that syntax of claims 14 and 42 can be improved by inserting a comma “,” before the term “wherein…”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—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 or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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.
Claims 7 and 9 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The written description in this case only sets forth a pharmaceutical composition comprising a heavy chain variable domain comprising an amino acid sequence of SEQ ID NO: 19, 21, 23, 25 or 27; and a light chain variable domain comprising an amino acid sequence of SEQ ID NO: 20, 22, 24, 26 or 28, and therefore the written description is not commensurate in scope with “any heavy chain variable domain that varies up to 15% in amino acid sequence of SEQ ID NO: 19, 21, 23, 25 or 27; or any light chain variable domain that varies up to 15% in amino acid sequence of SEQ ID NO:20, 22, 24, 26 or 28”.
The claims as currently presented can have a variant heavy chain variable domains may vary up to 15-20 amino acids from the amino acid sequence of SEQ ID NO: 19, 21, 23, 25 or 27 (each about 120 amino acids in length); and a light chain variable domain may also vary from 15 to 20 amino acids from the amino acid sequence of SEQ ID NO: 20, 22, 24, 26 or 28 (each about 111 amino acids in length). The specification at pg. 3 discloses that existing anti-PD1 antibody molecules suffer from problems associated with the failure of a large proportion of patients to respond to treatment. Therefore, the specification discloses to anti-PD1 antibody molecules 77E11 which is murine progenitor antibody (Fig. 1a and 1b). This antibody is humanized and termed PD1-1, PD1-2, PD1-3, PD1-4 and PD1-5 (page 22, 2nd paragraph) and Table 1. The specification, Table 4 discloses an epitope for PD1-3 but the specification fails to disclose any antibody that specifically binds to PD1 after a deletion, insertion or substitution of 15-20 amino acid in a heavy chain variables region and a light chain variable region. Making a polyclonal antibody against a polypeptide is well known in the art. Chamow and Ashkenazi state on page 52, 1st paragraph (TIBTECH 14: 52-60, 1996) teach that making human monoclonal antibodies (mAbs) which are suitable for therapeutics are difficult for two reasons. First, humans are generally tolerant to their own antigens. Second, ethical considerations place restrictions on the active immunization of humans for the purpose of generating mAbs. They suggest that alternative technologies have been used to generate mAbs for therapeutic purposes, such technologies are (i) to produce chimeric or humanized antibodies, (ii) to select antibodies from phage display library, (iii) to generate human antibodies in animals such as mice by replacing the genetic loci for endogenous antibodies with gene elements for human antibodies, and (iv) to generate an antibody like molecule by combining framework sequences from a human mAb with sequences from a human protein that carries a target recognition function. However, neither the specification nor the prior art teaches that substitution, deletion or insertion of 15-20 amino acids in the antibody frames would still result in specific binding of these antibodies to PD1. The general knowledge and level of skill in the art do not supplement the omitted description because specific, not general, guidance is what is needed.
Applicant is directed to the Guidelines for the Examination of Patent Applications Under the 35 U.S.C. 112, 1 "Written Description" Requirement, Federal Register, Vol. 66, No. 4, pages 1099-1111, Friday January 5, 2001.
Vas-Cath Inc. V. Mahurka, 19 USPQ2d 1111, states that applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention, for purposes of the written description inquiry, is whatever is now claimed (see page 1117). The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed.” (see Vas-Cath at page 1116).
A description of a genus may be achieved by means of a recitation of a representative number of species falling within the scope of the genus or of a recitation of structural features common to the members of the genus, which features constitute a substantial portion of the genus. Regents of the University of California v. Eli Lilly & Co., 119 F3d 1559, 1569, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997). In Regents of the University of California v. Eli Lilly (43 USPQ2d 1398-1412), the court held that a generic statement which defines a genus of nucleic acids by only their functional activity does not provide an adequate written description of the genus. The court indicated that, while applicants are not required to disclose every species encompassed by a genus, the description of the genus is achieved by the recitation of a representative number of species falling within the scope of the claimed genus. At section B (1), the court states an adequate written description of a DNA ... requires a precise definition, such as by structure, formula, chemical name, or physical properties, not a mere wish or plan for obtaining the claimed chemical invention.
As discussed above, the skilled artisan cannot envision the detailed genus of “variants of a light chain variable region having up to 15% of SEQ ID NO:20, 22, 24, 26 or 28 and/or variants of a heavy chain variable region having up to 15% of SEQ ID NO: 19, 21, 23, 25 or 27” and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of making a mutation. The compound itself is required. See Fiers v.Revel, 25USPQ2d 1601 at 1606 (CAFC 1993) and Amgen v.Baird, 30 Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. One cannot describe what one has not conceived. See Fiddes v. Baird, 30 USPQ2d 148 at 1483. In Fiddes, claims directed to mammalian FGF's were found to be unpatentable due to lack of written description for that broad class.
Therefore, only a pharmaceutical composition comprising the heavy chain variable domain comprising an amino acid sequence of SEQ ID NO: 19, 21, 23, 25 or 27; and a light chain variable domain comprising an amino acid sequence of SEQ ID NO: 20, 22, 24, 26 or 28, but not the full breadth of the claim meets the written description provision of 35 U.S.C. §112, first paragraph.
Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. 112 is severable from its enablement provision (see page 1115).
Conclusion
Claims 7 and 9 are rejected.
Claims 1-6, 8, 10-16, 25-26, 35, and 42-44 are allowed.
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/GYAN CHANDRA/Primary Examiner, Art Unit 1674