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 .
Withdrawn Rejections
The prior claim rejections over Charron (Gene Therapy for Phenylketonuria: Dominant-Negative Interference in A Recessive Disease. Dissertation. University of Florida. 2005) have been withdrawn in view of applicant’s amendments to the claims to recite a truncated sequence.
The rejection of claims 1-7 on the ground of nonstatutory double patenting as being unpatentable over claims 1, 18 and 22 of copending Application No. 16/652867 has been withdrawn in view of applicant’s submission of and the Office’s approval of a Terminal Disclaimer.
The rejection of claims 7-9 on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2 and 6 of U.S. Patent No. 11820999 has been withdrawn in view of applicant’s submission of and the Office’s approval of a Terminal Disclaimer.
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 1-6 and 9-11 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 claims are drawn to, inter alia, PAH sequences that are at least 90% identical to instant SEQ ID NOs: 3 and 4 or at least 95% identical to instant SEQ ID NOs: 1 and 2.
The written description rejection is made because the claims are interpreted as being drawn to a method employing a genus PAH sequences that are at least 90% identical to instant SEQ ID NOs: 3 and 4 (or at least 95% identical to instant SEQ ID NOs: 1 and 2). 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 SEQ ID NOs: 1-4 and test them for their ability to process phenylalanine (e.g. PAH), this process of guesswork does not put one in possession of the genus of PAH. 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 the PAH protein (i.e., SEQ ID NOs:1-4) and the function of that structure (i.e., ability to process phenylalanine). There is no disclosure of any particular portion of the structure of the PHA sequence that must be conserved or that can be altered in order to be “at least 90% identical” to SEQ ID NOs:3-4 as claimed in claim 1 (or at least 95% identical to instant SEQ ID NOs: 1 and 2 as claimed in claim 6) and retain the ability to process phenylalanine.
Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the claimed genus of PAH. 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 variant PAH sequences that are “at least 90% identical” to SEQ ID NOs:3-4 as claimed in claim 1 (or at least 95% identical to instant SEQ ID NOs: 1 and 2 as claimed in claim 6). Given that the specification has only described the structure and function of SEQ ID NOs:1-4, the full breadth of the claims does not meet the written description provision of 35 U.S.C. 112, first paragraph.
Response to Arguments
In the reply dated 8/4/2025, applicant argues that the amendments to the claims overcome the rejection. Applicant’s arguments have been considered and not found persuasive.
The genetic variation permitted by the claim language encompasses an inordinate number of nucleotide variants. However, the disclosure fails to provide any examples of modified PAH genes. The disclosure fails to identity which regions of any given sequence should be targeted for modification. SEQ ID NOS.: 1 and 2 encode phenylalanine hydroxylase. Changes in the nucleotide sequence may also alter the coding potential of the PAH protein. Single or multiple amino acid substitutions can alter the activity/function of PAH (Thorolfsson et al., 2003). The disclosure fails to describe the preparation and characterization of any PAH variants. With respect to the truncated 3’ UTR, the disclosure fails to identify how any given nucleotide substitution, insertion, or deletion will affect the regulatory properties of these regions. The lack of support in the disclosure suggests applicant did not contemplate making and using variant nucleotide sequences.
Accordingly, when all the aforementioned factors are considered in toto, the skilled artisan would reasonably conclude that applicant was not in possession of a sufficient number of species to support the full breadth of the patent protection desired. Applicant’s arguments have been considered but are not deemed to be persuasive for the reasons set forth above.
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