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 .
Status of the Claims
Claims 16-19, 21 and 23-25 have been withdraw as being directed to a non-elected invention. Claims 14-15 have been withdrawn as being directed to a non-elected species. Claims 1-4, 6-8, 10 and 12 are under examination at this time.
Priority
The disclosure of the prior-filed application, Application No. 16/642690, fails to provide adequate support or enablement in the manner provided by the first paragraph of 35 U.S.C. 112 for one or more claims of this application. Specifically, the prior application does not disclose “bovine leukemia virus” or “BLV”. Thus, claims reciting “bovine leukemia virus” or “BLV” will only be given a priority date of the instantly filed application, 2/27/2020.
Withdrawn Rejections
The rejection of claims 1, 2 and 4 under 35 U.S.C. 103 as being unpatentable over Ulrich et al. (DD 286816 A5; published 2/7/1991; machine translation) has been withdrawn in view of applicant’s amendments to claim 1.
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.
Claim 12 is 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 claim is directed to a vaccine composition comprising a bovine leukemia virus (BLV) antigen conjugated to a bacteriophage capsid, wherein said capsid comprises at least one non-natural mutation, wherein the mutation comprises at least one mutation selected from N10K, A38K, A40C, A40S, T75K, D102C, D102S, or Al17K. or combination thereof.
There are numerous known bacteriophage and bacteriophage capsid proteins. Applicant has not provided written support that a representative number of bacteriophage capsid proteins comprise, for example, Alanine at positions 38 and 40.
Accordingly, because the skilled artisan cannot envision the detailed chemical structure of the encompassed genus of capsid proteins used in the claimed vaccine composition, the full breadth of the claims does not meet the written description provision of 35 U.S.C. 112, first paragraph.
Claims 1-4 and 6-8 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 instant claims are directed to a vaccine composition comprising a bovine leukemia virus (BLV) antigen conjugated to a bacteriophage capsid, wherein said capsid comprises at least one non- natural mutation that induces a reduced anti-carrier immune response.
The written description rejection is made because the claims are interpreted as being drawn to, inter alia, a genus of bacteriophage capsid proteins comprising at least one non-natural mutation that can be any type of mutation at any position in the capsid protein. The applicable standard for the written description requirement can be found in MPEP 2163; University of California v. Eli Lilly, 43 USPQ2d 1398 at 1407; PTO Written Description Guidelines; Enzo Biochem Inc. v. Gen-Probe Inc., 63 USPQ2d 1609; Vas- Cath Inc. v. Mahurkar, 19 USPQ2d 1111; and University of Rochester v. G.D. Searle & Co., 69 USPQ2d 1886 (CAFC 2004). While one would be able to construct variants of a bacteriophage capsid protein comprising at least one non-natural mutation that can be any type of mutation (e.g., substitution, deletion or insertion) at any position in the capsid protein and test them for their ability to “induce a reduced anti-carrier immune response”, this process of guesswork does not put one in possession of the genus of polypeptides used in the composition. To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof. In this case, the only factor present in the disclosure is the bacteriophage capsid protein. There is no disclosure of any particular portion of the structure that can be mutated or the type and location of the mutation in order to induce a reduced anti-carrier immune response.
Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the claimed genus. A definition by function alone does not suffice to sufficiently describe a coding sequence because it is only an indication of what the gene does, rather than what it is. EliLily, 119 F.3 at 1568, 43 USPQ2d at 1406.
The court clearly states in Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, 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 is, for purposes of the 'written description' inquiry, whatever is now claimed." (See page 1117.) The specification does not clearly allow persons of ordinary skill in the art to recognize that the inventors invented what is claimed. As discussed above, the skilled artisan cannot envision the detailed chemical structure of the genus of capsid proteins comprising at least one non-natural mutation, which can be any type of mutation at any position in the capsid protein, where the resulting capsid protein induces a reduced anti-carrier immune response. Accordingly, the full breadth of the claims does not meet the written description provision of 35 U.S.C. 112, first paragraph.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 10 and 12 remain rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 10 still depends from a canceled claim.
Claim 12 is indefinite because the claim lacks a reference sequence for the cited mutation. Since the amino acid residues and positions vary in the different bacteriophage capsids, one of ordinary skill in the art would not be reasonably apprised of the metes and bounds of the invention without a reference sequence. Therefore, a sequence of a capsid protein referred by SEQ ID NO: should be recited in the claims as a reference for the mutations cited the claims.
It is noted that applicant amended claim 12 to recite the capsid protein of SEQ ID NO: 1. However, the amino acid mutations recited in claim 12 are not found in SEQ ID NO: 1. For example, position 38 should be Alanine. However, in SEQ ID NO: 1, position 38 is Gln.
Accordingly, one of ordinary skill in the art will not know the metes and bounds of the claims.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/NICOLE KINSEY WHITE/Primary Examiner, Art Unit 1672