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 .
Claim Status
Claim listing filed on February 2, 2026 is pending. Claims 1-10, 12-13, and 17 are amended. Claims 11, 15-16, and 21-22 are canceled. Claims 13-14, 17-20, and 23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions or species. Claims 1-10 and 12 are examined upon their merits.
Withdrawn Objections and Rejections
Applicant’s cancelation of Claim 11 has rendered all previous rejections directed to this claim moot.
The amendments to the specification overcome all objections of record, and the specification objections are withdrawn.
The amendments to Claims 2-4, 6-10, and 12 overcome the objections of record, and the claim objections directed to Claims 2-4, 6-10, and 12 are withdrawn.
The rejection of claims 3, 5-8, and 10 under 35 U.S.C. 112(b) as being indefinite is withdrawn in view of Applicant’s amendments to the claims.
Claim Objections (Maintained)
Claim 5 is objected to because of the following informalities:
Claim 5 recites “APC” in line 2 wherein “ACP” is the correct acronym.
Appropriate correction is required.
Applicant's arguments filed February 2, 2026 have been fully considered but they are not persuasive. Applicant argues that Claim 5 has been amended to recite “ACP”; however, in line 2, the incorrect acronym “APC” is still recited.
Claim Objections (New, necessitated by amendment)
Claim 1 is objected to because of the following informalities:
In Claim 1, line 2, “E. coli are” should be corrected to “E. coli are” wherein “are” is not italicized.
Appropriate correction is required.
Claim Rejections - 35 USC § 112 (Maintained)
The rejection of Claim 2 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 is maintained.
Claim 2b recites “wherein the plurality of ACP artificially linked via peptide linkers thereby creating branched or tree-like like linkages and the second ACP covalently linked to the linker in a structure ACP-linker-ACP arrangement.” As written, Claim 2b is so grammatically incorrect that the meaning of the claim is unclear. In contrast, Claim 2a is clear with proper verbs and conjunctions. For the purpose of compact prosecution, Claim 2b will be interpreted using the same language as Claim 2a, specifically “the plurality of ACP artificially linked via peptide linkers is a branched or tree-like linkage comprising a first ACP and a second ACP covalently linked to the linker in a structure ACP-linker-ACP arrangement.” This interpretation makes clear that a tandem ACP is described in Claim 2a and a branched or tree-like ACP is described in Claim 2b; however, appropriate correction to the claim language is required to make this structural distinction clear.
Applicant's arguments filed February 2, 2026 have been fully considered but they are not persuasive. Applicant argues that the amendments to Claim 2b changing “to create” to “thereby creating” makes the claim language clear; however, Examiner maintains that “wherein the plurality of ACP artificially linked via peptide linkers thereby creating” lacks a necessary verb prior to “thereby creating” because “the plurality of ACP artificially linked via peptide linkers” is directed to a single noun.
Claim Rejections - 35 USC § 112 (New, necessitated by amendment)
Claims 1-10 and 12 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 “a composition comprising Escherichia coli (E. coli) wherein the E. coli are characterized by a plurality of linked ACP.” It is unclear what is meant by “E. coli characterized by a plurality of linked ACP” as there is no definition of “characterized” or “E. coli characterized by ACP” in the specification. One of ordinary skill would not understand the structural metes and bounds of “E. coli characterized by a plurality of linked ACP.” For the purpose of compact prosecution, Claim 1 is interpreted with the broadest reasonable interpretation as “a composition comprising Escherichia coli (E. coli) wherein the E. coli comprise a plurality of linked ACP.” Claims 2-10 and 12 are rejected for their dependence on indefinite Claim 1.
Claim Rejections - 35 USC § 101 (Maintained)
The rejection of Claims 1-10 and 12 under 35 U.S.C. 101 because the claimed invention is directed to a nature-based product without significantly more is maintained.
Applicant's arguments filed February 2, 2026 have been fully considered but they are not persuasive. Applicant argues that the specification teaches artificial linkage of ACP domains from E. coli with PraA linkers from P. profundum, and this chimeric protein is not found in E. coli in nature. Examiner agrees that proteins comprising ACP domains from E. coli and linkers from P. profundum are not found in nature as they are a hybrid of two different bacteria; however, the claims are not directed to this invention. Currently, the claims are directed to E. coli comprising linked ACP wherein the ACP domains and peptide linkers can comprise any structure and originate from any type of bacteria. Therefore, amended Claim 1 is still directed to the tandem ACPs that are naturally produced by the bacteria Photobacterium profundum (of record in the non-final rejection filed 08/01/2025).
Reciting that the naturally-occurring linked ACP is in E. coli does not amount to significantly more than the judicial exception. MPEP § 2106.05(d) states that if “the additional element (or combination of elements) is no more than well-understood, routine, conventional activities previously known to the industry, which is recited at a high level of generality, then this consideration does not favor eligibility.” The courts have recognized that using polymerase chain reaction to amplify and detect DNA and amplifying and sequencing nucleic acid sequences are examples of laboratory techniques that are well-understood, routine, and conventional in the life science arts (MPEP § 2106.05(d).II). Similarly, it is well understood in the art that a gene of interest can be inserted into an expression plasmid and transformed into E. coli to express the protein of interest, as evidenced by Trujillo et al. PLoS ONE 2013 (of record). Trujillo teaches that the ACP domain of P. profundum was amplified by PCR and cloned into an expression vector for production in E. coli (page 2, last paragraph). Therefore, expressing naturally-occurring tandem ACPs in E. coli does not amount to significantly more than the judicial exception, and the rejection is maintained.
Alternative claim language to potentially overcome the 101 rejection of record could recite “wherein the ACP domains comprise SEQ ID NO: 8 and the peptide linkers comprise SEQ ID NO: 7” wherein SEQ ID NO: 8 is the E. coli ACP and SEQ ID NO: 7 is the P. profundum linker (as evidenced by specification Table 3).
Claim Rejections - 35 USC § 102 (Modified, necessitated by amendment)
The rejection of Claims 1-10 and 12 under 35 U.S.C. 102(a)(1) as being anticipated by Trujillo et al. PLoS ONE 2013 (of record) is maintained.
Amended Claim 1 is directed to a composition comprising E. coli wherein the E. coli comprise a plurality of linked ACP. Trujillo teaches that the tandem ACP domains of P. profundum were amplified by PCR and cloned into an expression vector for production in E. coli (page 2, last paragraph). Therefore, Trujillo anticipates E. coli comprising a plurality of linked ACP.
Applicant's arguments filed February 2, 2026 have been fully considered but they are not persuasive. Applicant argues that Trujillo does not teach a composition comprising E. coli having all the limitations as recited in amended Claim 1. As stated above, Trujillo does teach a composition comprising E. coli wherein the E. coli express the tandem ACP domains of P. profundum. Detailed explanation of how the tandem ACP domains of P. profundum taught by Trujillo read on Claims 1-10 and 12 is of record in the non-final office action filed 08/01/2025. The rejection is maintained.
Double Patenting (New, necessitated by amendment)
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.
1. Claims 1-10 and 12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over Claim 1 of copending U.S. App. No. 18/700,565 as evidenced by Trujillo et al. PLoS ONE 2013 (of record).
The instant claims are directed to a composition comprising E. coli wherein the E. coli comprise linked tandem ACP in a beads-on-a-string arrangement (Claims 1-7). Claims 8-10 are product-by-process claims where the product is defined by the process in which it is made. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself (MPEP § 2113). Claim 12 recites wherein fatty acid biosynthesis production of tandem linked ACP is increased compared with a single-domain ACP and is interpreted as an inherent functional property of the tandem linked ACP structure (ACP-linker-ACP) as defined in Claim 1 (MPEP § 2112.01.I-II).
The copending claims recite an E. coli containing pfaA, pfaB, pfaC, pfaD, and/or pfaE genes (Claim 1). Trujillo defines wherein the pfaA gene encodes five tandem ACPs connected by linkers in a beads-on-a-string arrangement (abstract and Fig. 1).
Therefore, the copending claims are directed to E. coli comprising nucleic acid that encodes tandem ACPs and the instant claims are directed to E. coli comprising the tandem ACPs. Because it is well understood that DNA is transcribed into RNA which is translated into protein (the central dogma of molecular biology), the instant claims are either anticipated and/or rendered obvious by the copending claims as evidenced by Trujillo. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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 SARAH COOPER PATTERSON whose telephone number is (703)756-1991. The examiner can normally be reached Monday - Friday 8:00am - 5:00pm EST.
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/SARAH COOPER PATTERSON/ Examiner, Art Unit 1675
/JEFFREY STUCKER/ Supervisory Patent Examiner, Art Unit 1675