CTFR 18/246,966 CTFR 98130 DETAILED ACTION Status of claim rejections The objections to the claims are withdrawn in view of Applicant’s amendments to the claims in the response filed 04/07/2026. The rejections under 35 USC 112(a) are maintained in view of Applicant’s amendments to the claims/arguments in the response filed 04/07/2026. The rejections under 35 USC 112(b) are withdrawn in view of Applicant’s amendments to the claims in the response filed 04/07/2026. The rejections under 35 USC 112(d) are withdrawn in view of Applicant’s amendments to the claims in the response filed 04/07/2026. The rejections of the claims under 35 USC 102/103 and 35 USC 103 are withdrawn in view of Applicant’s amendments to the claims/arguments in the response filed 04/07/2026. This Action is FINAL. Maintained Claim Rejections - 35 USC § 112 07-30-01 AIA 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. 07-31-01 Claims 1, 3, 14, 22, and 49 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 requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the inventor was in possession of the claimed genus. See , e.g. , Ariad Pharm., Inc. v. Eli Lilly & Co. , 598 F.3d 1336, 1340, 94 USPQ2d 1161, 1167 (Fed. Cir. 2010); University of California v. Eli Lilly & Co. , 119 F.3d 1559, 43 USPQ2d 1398 (Fed. Cir. 1997) at 1406; Juno Therapeutics, Inc. v. Kite Pharma, Inc. , 10 F.4th 1330, 1337, 2021 USPQ2d 893 (Fed. Cir. 2021) ("[T]he written description must lead a person of ordinary skill in the art to understand that the inventor possessed the entire scope of the claimed invention. Ariad , 598 F.3d at 1353–54 ('[T]he purpose of the written description requirement is to ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor's contribution to the field of art as described in the patent specification.' (internal quotation marks omitted)."). A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc. , 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014). The issue is whether the skilled artisan would understand inventor to have invented, and been in possession of, the invention as claimed. Claim interpretation: The claims require, inter alia , “the recombinant microorganism comprises . . . a nucleic acid sequence comprising an exogenous DAHP synthase of EC 4.1.2.15, or EC 2.5.1.54, wherein the exogenous DAHP synthase of EC 4.1.2.15, or EC 2.5.1.54 comprises a feedback-inhibition resistant mutation in a wild-type amino acid sequence of the DAHP synthase , and wherein the recombinant microorganism comprises a nucleic acid sequence set forth in SEQ ID NO: 45 ” (emphasis added). A “feedback-inhibition resistant mutation in the wild-type amino acid sequence of the DAHP synthase” as claimed has been interpreted to be any mutation, including any deletions, substitutions, additions, etc. anywhere within/along any wildtype sequence of DAHP synthase with the functional property of creating resistance to feedback inhibition in the recombinant microorganism. The question at issue is whether the skilled artisan would envision the correlation between structure of the broad genus of DAHP synthase mutants and ability to create resistance to feedback inhibition in the recombinant microorganism, as there is no correlation or defining characteristic that would convey the identity of the structure necessary to perform the claimed function. Reduction to practice and disclosure of drawings or structural chemical formulas : Applicant discloses in the specification AroG Eco S180F (E. coli feedback-inhibition resistant DAHP synthase) in SEQ ID NO: 1, SEQ ID NO: 53, 61, and 65 (tagged DAHP synthase) (see Table 1). Instant claim 3 requires a feedback-inhibition resistant mutation of serine to phenylalanine at position 180 and claim 22 recites at least SEQ ID NO: 1, which the specification discloses is the AroG Eco S180F feedback resistant E. coli DAHP synthase ( i.e., only claims 3 and 22 contain an embodiment of the mutation reduced to practice, though are not limited to those embodiments). Applicant discloses that SEQ ID NO: 45 is a single synthetic operon containing a vector sequence encoding the genetically engineered pathway, that has been codon-optimized for expression in Methylococcus capsulatus Bath. Applicant has not disclosed any other mutations in the wildtype DAHP synthase that provides feedback-inhibition resistance. Sufficient, relevant, identifying characteristics, i.e. , structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure: Applicant has not provided information as to the defining structural characteristics that would lead one of ordinary skill in the art to the identity of a DAHP synthase mutant capable of “exhibiting feedback resistance”. Applicants are claiming, essentially, any mutation along the sequence of DAHP synthase (additions, substitutions, deletions, etc.) that would impart this function onto the enzyme. This means that the DAHP synthase mutant has a functional limitation of having feedback-inhibition resistance. However, under broadest reasonable interpretation, the enzyme can encompass any mutated sequence or portion thereof, but Applicants have not disclosed which portion of the enzyme is necessary for the functional limitation as claimed. Even with knowledge in the art regarding the mutation of amino acids, one of ordinary skill would not know what structural features are required for the outcome of conferring feedback inhibition resistance in the protein without a recognized correlation between structure and function. In essence, Applicants are describing a critical portion of their invention by function. This is not sufficient to meet the written description requirement. Lack of support for massive genus of DAHP synthase mutants : In support of the claimed genus, the specification demonstrates only the serine to phenylalanine mutation at position 180 is capable of providing feedback-inhibition resistance (see, e.g., Table 1). However, there is no support in the specification feedback-inhibition resistance using any and all possible mutations in the wildtype DAHP synthase sequence ( e.g., any mutation at position 180, or any mutation anywhere along the sequence). Applicant has not provided any information that would allow one of ordinary skill to reasonably understand that any mutation is capable of providing the functional limitation claimed. Thus, the data generated for the use of the S180F mutation to confer feedback-inhibition resistance cannot reasonably be extrapolated to and applied to support possession of the entire claimed genus of DAHP synthase mutants as claimed, because no one species, combination, or variant accounts for the variability amongst the claimed genus. As in Ariad , merely drawing a fence around the outer limits of a purported genus is not an adequate substitute for describing a variety of materials constituting the genus and showing that one has invented a genus and not just a species. “A patent is not a hunting license. It is not a reward for the search, but compensation for its successful conclusion.” Brenner v. Manson , 383 U.S. 519, 536 (1966). The specification, then, is considered devoid of sufficiently detailed, relevant, identifying characteristics demonstrating that Applicant was in possession of the claimed genus of subject(s) in need thereof, i.e., additional complete or partial structures, other physical and/or chemical properties, functional characteristics coupled with a known or disclosed correlation between function and structure, or some combination thereof demonstrating possession of the claimed genus. Therefore, the claims are rejected under 35 U.S.C. 112(a) for lack of written description. Response to Arguments On pg. 6 of the remarks, Applicant argues that the amendment of claim 1 to recite the limitation of claim 16 is enough to overcome the rejection. In response, the examiner disagrees. The addition of the recombinant microorganism nucleic acid sequence of SEQ ID NO: 45 does not overcome the rejection because there is no support in the specification feedback-inhibition resistance using any and all possible mutations in the wildtype DAHP synthase sequence ( e.g., any mutation at position 180, or any mutation anywhere along the sequence). Applicant has not provided information as to the defining structural characteristics that would lead one of ordinary skill in the art to the identity of a DAHP synthase mutant capable of “exhibiting feedback resistance”. Applicants are claiming, essentially, any mutation along the sequence of DAHP synthase (additions, substitutions, deletions, etc.) that would impart this function onto the enzyme. This means that the DAHP synthase mutant has a functional limitation of having feedback-inhibition resistance. However, under broadest reasonable interpretation, the enzyme can encompass any mutated sequence or portion thereof, but Applicants have not disclosed which portion of the enzyme is necessary for the functional limitation as claimed. Thus, the rejection is maintained as set forth above. Examiner’s Note The examiner notes that the instant claims have been amended to require a recombinant microorganism comprising a nucleic acid sequence set forth in SEQ ID NO: 45. The previously cited Ward reference teaches a method for producing p-hydroxybenzoic acid biocatalytically in a microbial cell transformant via the common pathway of aromatic compounds synthesis, said method comprising: culturing the cell transformant in media containing an assimilable carbon source under conditions conducive to the assimilation of said carbon source, said cell transformant comprising exogenous DNA sequences encoding DAHP synthase, transketolase, PEP synthase, chorismate synthase, shikimate kinase, EPSP synthase, DHQ synthase, and chorismate pyruvate lyase, wherein said exogenous DNA sequences encoding chorismate pyruvate lyase, DAHP synthase, transketolase, and PEP synthase are transcribed from a first promoter (see claim 1 and 2). Ward also teaches that the DAHP can be from EC 4.1.2.15 (col 4, lines 10-20), and that industrial production of primary metabolites derived from chorismite deregulated mutant strains that lack feedback inhibition of one or more of the enzymes including E. coli strains having DAHP synthase feedback inhibition removed. Previously cited Ger et al teaches (DAHP synthetase, EC 4.1.2.15) catalyzes the first committed step in the biosynthesis of aromatic acids and vitamins (see pg. 986 col 1; abstract). Ger teaches that a DAHP synthetase enzyme resistant to feedback inhibition of phenylalanine would be critical to unraveling the mechanism of feedback inhibition as well as in attempting to overproduce aromatic amino acids through fermentation (see 986, col 1). Ger further teaches, inter alia , site-directed mutagenesis of serine at position 180 to phenylalanine, which resulted in a feedback-insensitive mutant with comparable enzymatic activity to the wildtype but decline of feedback inhibition from 60% to less than 10% Replacement of Ser-180 (abstract; see also pg. 989 col 1, paragraph 2). Previously cited Yukawa taught chorismite pyruvate lyase mutants useful for improving the production of 4-hydroxybenzoic acid ( i.e., pHBA) (see abstract; claims). Yukawa explicitly teaches a transformant obtained by introducing a lyase from P. rustigianni (ubiC) into a host cell before culturing the transformant, and a sequence of chorismite pyruvate lyase that has 100% sequence identity to SEQ ID NO: 4. However, as disclosed in the previous Office Action, after searching SEQ ID NO: 45 (see claim 16), the sequence has been deemed free of the prior art, as the prior art fails to teach or suggest the recombinant microorganism sequence. As such, the prior art rejections of record have been withdrawn. Please note that while the prior art rejections have been withdrawn, the instant claims are not allowable for the reasons set forth in the 35 USC 112(a) rejection above. Conclusion NO CLAIMS ALLOWED. 07-39 AIA 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. Any inquiry concerning this communication or earlier communications from the examiner should be directed to GEORGIANA C REGLAS whose telephone number is (571)270-0995. The examiner can normally be reached M-Th: 8:00am-2:00pm. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melenie Gordon can be reached at 571-272-8037. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /G.C.R./Examiner, Art Unit 1651 /THOMAS J. VISONE/Supervisory Patent Examiner, Art Unit 1672 Application/Control Number: 18/246,966 Page 2 Art Unit: 1651 Application/Control Number: 18/246,966 Page 3 Art Unit: 1651 Application/Control Number: 18/246,966 Page 4 Art Unit: 1651
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