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 34-36 and 38 have been withdraw as being directed to a non-elected invention. Claims 17, 20 and 24 have been withdrawn as being directed to a non-elected species. Claims 1, 3, 6-16, 18-19, 21-23, 25-33 are under examination at this time.
Withdrawn Rejections
The rejection of claims 1, 22 and 27-32 under 35 U.S.C. 102(a)(1) as being anticipated by Kwong et al. (WO2016037154; published March 10, 2016; cited by applicant) has been withdrawn in view of applicant’s amendments to claim 1.
The rejection of claims 1, 3-16, 18-19, 21 and 25-33 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or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement has been withdrawn in view of applicant’s amendments to claim 1 to recite that the cage polypeptide is at least 90% identical to any one of SEQ ID NO: 20-39.
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 1, 3, 6-16, 18-19, 21, 25-33 are rejected under 35 U.S.C. 112, first paragraph, as failing to comply with the written description requirement. The claim 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 inventors, at the time the application was filed, had possession of the claimed invention.
The claim is drawn to, inter alia, a protein cage polypeptide where Polypeptide 1, Polypeptide 2, Polypeptide 3, and Polypeptide 4 are each at least 90% identical to a portion of any one of instant SEQ ID NOs:20-39 and where the protein cage polypeptide is at least 90% identical to any one of instant SEQ ID NOs:20-39.
The written description rejection is made because the claims are interpreted as being drawn to a method employing a genus of polypeptides recited as being at least 90% identical to a portion of any one of instant SEQ ID NOs:20-39 and employing a genus of protein cage polypeptides that are at least 90% identical to any one of instant SEQ ID NOs:20-39. 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 Polypeptides 1-4 and variants of cage polypeptides SEQ ID NOs: 20-39 and test them for their ability to form a tetrahedral pyramid structure and their ability to bind to an antibody, this process of guesswork does not put one in possession of the genus of polypeptides and cage polypeptides used in the claims. 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 structure of Polypeptides 1-4 (i.e., specified segments of any one of SEQ ID NOs:20-39) and cage polypeptides (i.e., SEQ ID NOs: 20-39) and the function of that structure (i.e., ability to form a hollow tetrahedral pyramid and bind to an antibody). There is no disclosure of any particular portion of the structure that must be conserved or that can be altered in order to be at least 90% identical to a specified segment of SEQ ID NOs: 20-39 or 90% identical to any one of SEQ ID NOs:20-39 and retain the ability to form a hollow tetrahedral pyramid and bind to an antibody.
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 encompassed genus of Polypeptides 1-4 that are at least 90% identical to a specific portion of any one of SEQ ID NOs:20-39 or cage polypeptides that are at least 90% identical to any one of instant SEQ ID NOs:20-39. Given that the specification has only described the structure and function of SEQ ID NOs:20-39, 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.
Claims 1, 3, 6-16, 18-19, 21-23, 25-33 are 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 1 recites that “INSERT A and INSERT B independently designate a site at which the amino acid sequence that specifically binds to an antibody or part thereof is introduced” and INSERT A corresponds to positions 318 and 322 of SEQ ID NO: 40, and INSERT B corresponds to positions 442 to 449 of SEQ ID NO: 40. Later, claim 1 recites that INSERT A and/or INSERT B each independently comprise the amino acid sequence DCAWHLGELVWCT (SEQ ID NO:41) or GCDCAWHLGELVWCTCG (SEQ ID NO:42). It is not clear how INSERT A and INSERT B can be defined as both a site for insertion of a sequence and as SEQ ID NO: 41 and/or SEQ ID NO: 42. This rejection affects claims that depend from claim 1 as well.
Accordingly, one of ordinary skill in the art will not know the metes and bounds of the claim.
Claims 23 and 32 are 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 23 is directed to the protein cage polypeptide of claim 22, wherein the protein cage polypeptide comprises an amino acid sequence comprising any one or more, or all, stretches of the bolded and underlined recited amino acid residues of SEQ ID NO: 40. Claim 1 limits the sequences of the cage polypeptide to instant SEQ ID NOs:20-39. Thus, it is not clear if claim 23 is an attempt to include SEQ ID NO: 40 as a cage polypeptide sequence or if claim 23 is defining specific amino acid residues within each of SEQ ID NO: 20-39.
Claim 32 is directed to the protein cage polypeptide, or scaffolding protein, of claim 1, wherein the protein cage polypeptide, or scaffolding protein, is binding specifically to the antibody or part thereof, or any chimeric protein, molecule or compound comprising the antibody, or part thereof; wherein the antibody or part thereof is binding specifically to a pathogenic biological agent, or part thereof.
The phrase “wherein the antibody or part thereof is binding specifically to a pathogenic biological agent, or part thereof” is unclear. Claim 1 recites that the antibody binds to an amino acid sequence that is within the protein cage polypeptide. It is not clear if the antibody of claim 32 is binding to the amino acid sequence recited in claim 1 or if the antibody of claim 32 is binding to some other sequence on a pathogenic biological agent.
Accordingly, one of ordinary skill in the art will not know the metes and bounds of the claim.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nicole Kinsey White whose telephone number is (571)272-9943. The examiner can normally be reached M to Th 6:30 am to 6:00 pm.
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/NICOLE KINSEY WHITE/Primary Examiner, Art Unit 1672