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 .
Applicant’s arguments and amendments filed on 1/30/2026 have been entered.
Claims 34-36, 38, 43-45, 47, 48 and 53 have been amended.
Claims 54-57 are new.
In view of Applicants arguments and amendments the written description rejection has been amended.
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 34-41, 43-45, 47, 48 and 53 remain rejected and new claims 54-57 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 for reasons of record in the Non-Final Office action mailed on 11/5/2025 (and repeated below as amended). 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.
When the claims are analyzed in light of the specification, the instant invention encompasses an insertion of a heterologous peptide from position 3 to position 9 of amino acids sequences set forth in SEQ ID NOs: 50, 56, 61 or 63 in the capsid protein VP1 GH loop corresponding to amino acids 570 and 611 of a capsid protein VP1 of AAV2.
Regarding function, the claims recite that rAAV will exhibit at least 5-fold increased infectivity of a retinal cell compared to the infectivity of the retinal cells by a control AAV virion comprising a corresponding parental AAV capsid protein.
However, the specification provides no description of any insertion, other than the specific sequences inserted between amino acids 570 and 611 of VP1 of AAV2, that would indicate possession at the time of filing for an rAAV that would form a capsid and have the function of increased infectivity as recited in the instant claims. It is generally known that the AAV2 VP1 protein is highly structured, and inserting a heterologous peptide from position 3 to position 9 of amino acids sequences set forth in SEQ ID NOs: 50, 56, 61 or 63 anywhere between the amino acids from 570 and 611 would l likely disrupt the virus's ability to bind cells, infect targets, or assemble properly into a capsid (see Choi et al 2005, Curr. Gene There. 5(3), 299-310).
In analyzing whether the written description requirement is met for genus claims, it is first determined whether a representative number of species have been described by their structure. In the instant case, only an insertion at the specific residues between amino acids 570-611 of VP1 of AAV2 is sufficiently described to indicate possession of an rAAV that will form a capsid and exhibit the function of increased infectivity of retinal cells. This is significant because the claims have been amended to that the heterologous peptides comprises from position 3 to position 9 an amino acid sequence selected from the group consisting of SEQ ID NOs: 50, 56, 61 or 63.
However, the specification does not provide any disclosure as to what the complete structure would be of any other insertion sites in the GH loop other than the one disclosed in the specification that would form a rAAV capsid and function as claimed. There is no general knowledge in the art about regarding rAAV capsids and insertion of a peptide sequence in the GH loop and would result in increased infectivity to suggest that general similarity of structure confers the activity.
Next, then, it is determined whether a representative number of species have been sufficiently described by other relevant identifying characteristics, specific features and functional attributes that would distinguish different members of the claimed genus. In the instant case, the only characteristic described, is that when the heterologous peptide is inserted between amino acids 570 and 611 of VP1 of AAV2 that an increase in infectivity occurs. The specification does not teach any other identifying characteristics such as domains relating to function/activity or any other related sequences that would guide the artisan to contemplate other sites of insertion that would impart the claimed increased in infectivity. This is significant because while the claims and the specification claim or contemplate an increase of at least 5-fold in infectivity. The specification does not teach what the complete structure, i.e. sequence, using the claimed sequences in SEQ ID NOs: 50, 56, 61 or 63.
This is significant since the specification does not teach what the structure of a modified capsid where the heterologous peptide is inserted anywhere in the GH loop (in any AAV other than AAV2) and would result in forming a capsid as required by the claim and function with increased infectivity. This is significant since the art teaches that mutations in a capsid can prevent the capsid from forming in an AAV and alter the function of an AAV (see Choi et al, 2005, Curr. Gene Ther., Vol. 5(3), pgs. 299-310, specifically pg. 12 parag. 4).
The skilled artisan could not rely upon the disclosure in the specification such that the specification would sufficiently describe that Applicant was in possession of variants of an rAAV that would comprise an insertion of a heterologous peptide anywhere in the GH loop at the time of filing.
Applicants' attention is directed to the decision in Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111, which clearly 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 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 [he or she] invented what is claimed." (See Vas-Cath at page 1116).
With the exception of the sequences referred to above, the skilled artisan cannot envision the detailed chemical structure of the encompassed polynucleotides, and therefore conception is not achieve regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The nucleic acid itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016.
One cannot describe what one has not conceived. See Fiddes v. Baird, 30 USPQ2d 1481 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. The specification provided only the bovine sequence.
Therefore, only an insertion of a heterologous peptide between amino acids 570 and 611 of VP1 of AAV2 meet 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).
The claimed invention as a whole is not adequately described if the claims require essential or critical elements that are not adequately described in the specification and that is not conventional in the art as of applicants effective filing date. Possession may be shown by actual reduction to practice, clear depiction of the invention in a detailed drawing, or by describing the invention with sufficient relevant identifying characteristics such that a person skilled in the art would recognize that the inventor had possession of the claimed invention. Pfaff v. Wells Electronics, Inc., 48 USPQ2d 1641,1646 (1998).
In conclusion, this limited information is not deemed sufficient to reasonably convey to one skilled in the art that applicant is in possession of the genus of rAAV’s thereof as embraced by the claims.
Response to Argument
While Applicant’s arguments have been fully considered they are not found persuasive. While Applicant has amended the claims to recite the corresponding region of the insertion between amino acids 570 and 611 of the capsid protein of VP1 of AAV2, the claims remain rejected with respect to written description for the reasons set forth above.
Conclusion
No claims are allowed. The claims are free of the prior art.
THIS ACTION IS MADE FINAL. 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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DAVID A. MONTANARI
Examiner
Art Unit 1632
/ANOOP K SINGH/Primary Examiner, Art Unit 1632
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