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 .
The preliminary amendment filed 6/16/2025 is acknowledged. Claims 1-30 are cancelled. New claims 31-48 are added. Claims 31-48 are pending and are currently under examination.
Information Disclosure Statement
The information disclosure statements filed on 9/16/2026 have been considered. Signed copies are enclosed.
Claim Rejections - 35 USC § 112
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 48 is 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 pre-AIA the applicant regards as the invention.
Claim 48 is indefinite because it is not clear how the step of detecting levels of phenylalanine, hippurate, and/or transcinnamic acid fit into the parent claim. It is not clear at what point in the method the levels are to be determined or using what samples.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 31-48 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Patent No. 12171790. Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons.
The instant claims are drawn to a genetically engineered microorganism comprising: one or more gene(s) encoding a mutant phenylalanine ammonia lyase (PAL) polypeptide, wherein the mutant PAL polypeptide comprises one or more mutations at amino acid positions selected from (a) S92G; H133M; I167K; L432I; V470A; (b) S92G; H133F; A433S; V470A; or (c) S92G; H133F; A263T; V470A compared to a wildtype Photorhabdus luminescens PAL comprising an amino acid sequence of SEQ ID NO: 1, wherein the gene encoding the mutant PAL polypeptide is operably linked to an isopropyl β-D-1-thiogalactopyranoside (IPTG)-inducible promoter, a thermoregulated promoter, or an oxygen-level dependent promoter; one or more gene(s) encoding a phenylalanine transporter wherein the gene(s) encoding the phenylalanine transporter is operably linked to an inducible promoter that is not associated with the gene(s) in nature; and optionally one or more gene(s) encoding an L-amino acid deaminase (LAAD), wherein the gene(s) encoding the LAAD is operably linked to an inducible promoter that is not associated with the gene(s) in nature.
The patented claims are drawn to genetically engineered microorganism comprising: one or more gene(s) encoding a mutant phenylalanine ammonia lyase (PAL) polypeptide, wherein the mutant PAL polypeptide comprises one or more mutations at amino acid positions selected from S92, H133, I167, L432, V470, A433, A263, K366 and L396 compared to a wildtype Photorhabdus luminescens PAL comprising an amino acid sequence of SEQ ID NO: 1, wherein the gene encoding the mutant PAL polypeptide is operably linked to an isopropyl β-D-1-thiogalactopyranoside (IPTG)-inducible promoter, a thermoregulated promoter, or an oxygen-level dependent promoter; one or more gene(s) encoding a phenylalanine transporter wherein the gene(s) encoding the phenylalanine transporter is operably linked to an inducible promoter that is not associated with the gene(s) in nature; and optionally one or more gene(s) encoding an L-amino acid deaminase (LAAD), wherein the gene(s) encoding the LAAD is operably linked to an inducible promoter that is not associated with the gene(s) in nature. Each of the limitations recited in the instant claims is recited in the patented claims. Therefore, the instant claims are anticipated by the patented claims.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Brian J Gangle whose telephone number is (571)272-1181. The examiner can normally be reached M-F, 9-6:30.
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/BRIAN GANGLE/ Primary Examiner, Art Unit 1645
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