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 .
This action is in response to the amendment filed 04/06/2026, in which claims 1-12 were canceled and claims 13 and 14 were newly added. Claims 13 and 14 are currently pending.
Applicant’s arguments have been thoroughly reviewed, but are not persuasive for the
reasons that follow. Any rejection and objections not reiterated in this action have been
withdrawn. This action is FINAL.
Priority
Acknowledgement of the receipt of the certified foreign priority application and the certified translation filed on 04/06/2026.
Therefore, all claims are given the effective filing date of 11/21/2019, filed as JP2019/210114. All claims are given the priority date of 11/21/2019.
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.
This is a NEW rejection necessitated by Applicant’s amendments to the claims filed on 04/06/2026.
Claims 13 and 14 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for an SLH-domain containing outer membrane protein or gene wherein the sequence comprises 100% identity to any of SEQ ID NOs: 1 and/or 7 as well as a cell wall-pyruvic acid modifying enzyme or gene wherein the sequence comprises 100% identity to any of SEQ ID NOs: 4 and/or 10, does not reasonably provide enablement for a gene or protein involved in the binding between the outer membrane and the cell wall is at least one of a surface layer homology (SLH) domain-containing outer membrane protein or a cell wall-pyruvic acid modifying enzyme, the SLH domain-containing outer membrane protein is:Slr1841 having an amino acid sequence of SEQ ID NO: 1; or a protein having an amino acid sequence that is at least 90 percent identical to the amino acid sequence of the Slr1841, and the cell wall-pyruvic acid modifying enzyme is:Slr0688 having an amino acid sequence of SEQ ID NO: 4; or a protein having an amino acid sequence that is at least 90 percent identical to the amino acid sequence of the Slr0688. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
Enablement is considered in view of the Wands factors (MPEP 2164.01(A)). These include: the breadth of the claims, the nature of the invention, the state of the prior art, the level of one of ordinary skill, the level of predictability in the art, the amount of direction provided by the inventor, the existence of working examples, and the quantity of experimentation needed to make or use the invention. All of the Wands factors have been considered with regard to the instant claims, with the most relevant factors discussed below.
Nature of the invention: The claims are drawn to a modified cyanobacterium in which a function of a protein involved in binding between an outer membrane and a cell wall of cyanobacterium is suppressed or lost.
Breadth of the claims: The claims broadly encompass a modified cyanobacterium in which a function of a protein involved in binding between an outer membrane and a cell wall of cyanobacterium is suppressed or lost wherein the protein involved in the binding between the outer membrane and the cell wall is at least one of a surface layer homology (SLH) domain-containing outer membrane protein or a cell wall-pyruvic acid modifying enzyme. The complex nature of the subject matter of this invention is greatly exacerbated by the breadth of the claims.
Guidance of the specification and existence of working examples: The specification describes a modified cyanobacterium in which a function of a protein involved in binding between an outer membrane and a cell wall of cyanobacterium is suppressed or lost wherein the protein involved in the binding between the outer membrane and the cell wall is at least one of a surface layer homology (SLH) domain-containing outer membrane protein or a cell wall-pyruvic acid modifying enzyme (Page 6, Line 29 bridging Page 7, Line 12). The specification describes two types of modified cyanobacteria were produced by suppressing the expression of slr1841 gene encoding a SLH domain-containing outer membrane protein (Example 1) and suppressing the expression of slr0688 gene encoding a cell wall-pyruvic acid modifying enzyme (Example 2) as methods for partially detaching the outer membrane of cyanobacterium from the cell wall (Page 32, Lines 1-7). The specification and working examples do not include the use of any other SLH domain containing outer membrane protein or cell wall-pyruvic acid modifying enzyme other than the slr1841 and slr0688, respectively, showing that no testing or experimentation was completed with other variants of the SLH domain-containing outer membrane protein and/or cell wall-pyruvic acid modifying enzymes.
Predictability and state of the art:
Qiu et al (Appl Environ Microbiol 84: e01512-18; 2018) teaches the attempted knock out the six putative porin-encoding genes in Synechocystis 6803, of which only four (sll0772, sll1271, sll1550 and slr0042) were successfully knocked out, and the mutation of five or all six porin-encoding genes was lethal to Synechocystis 6803 (Page 7, Paragraph 2). Showing that not all variants of the SLH domain proteins are capable of successfully knocking out the binding of the outer membrane to the cell wall.
Gordon et al (Adv Exp Med Biol. 2018; 1080: 281-315) teaches that while some slr proteins showed 10-fold repression, the slr0091 protein only showed 2-fold repression in PCC6803 (Page 14, Paragraph 1). Therefore, targeting of different slr proteins/genes showed different levels of repression of that gene/protein.
Amount of experimentation necessary: In order to practice the claimed invention, an immense amount of experimentation would be required. As disclosed above, the specification itself provides description of the SLH-domain containing outer membrane proteins and the cell wall-pyruvic acid modifying enzymes comprising the sequences of SEQ ID NOs: 1-12. No description is provided of any fragments or sequences comprising less than 100% identity to the sequences claimed that is capable of functioning and preforming the same activity of the sequences claimed. Except for the full sequences disclosed and claimed, for experimentation, first the SLH-domain containing outer membrane protein and/or the cell wall-pyruvic acid modifying enzyme would need to be identified wherein this would require a large amount of experimentation with no knowledge of which structures would be capable of performing the exact activity to cause the separation of the cell wall from the outer-membrane. Second, the SLH-domain containing outer membrane protein and/or the cell wall-pyruvic acid modifying enzyme would need to be tested in order to confirm that the protein/enzyme would be capable of successfully causing separation of the cell wall from the outer-membrane of the cyanobacteria. The specification does teach how the miRNA inhibitors function and how the structure of the miRNA inhibitor structure contributes to that function. Therefore, experiment could be conducted, but in view of the specification there does not appear to be any amount of experimentation that would be sufficient to reliably produce the exact product of the invention. Such experimentation would not be possible due to not having the steps or complete required structure of the SLH-domain containing outer membrane protein and/or the cell wall-pyruvic acid modifying enzyme. Therefore, it would require immense amount of unpredictable experimentation to practice the claimed invention with such variants in the possible result.
In view of the breadth of the claims and the lack of guidance provided by the specification as well as the unpredictability of the art, the skilled artisan would have required an undue amount of experimentation to make and/or use the claimed invention. Therefore, claims 13 and 14 are not considered to be fully enabled by the instant disclosure.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 13 and 14 are rejected under 35 U.S.C. 102(a)(1) as being unpatentable by Qiu et al (Appl Environ Microbiol 84: e01512-18, Pgs. 1-15; 2018; Cited in a Prior Office Action) as evidenced by GenBank Accession Number BAA17449.1 (slr1841 [Synechocystis sp. PCC 6803]; Oct. 7, 2016; Pg1/2-2/2) and NCBI Reference Sequence: NC_000911.1 (Synechocystis sp. PCC 6803 DNA, complete genome; Jan, 7th, 2019; Pgs 1/2-2/2). This is a NEW rejection necessitated by Applicant’s amendments to the claims filed on 04/06/2026.
Regarding claims 13 and 14, the claim is interpreted that “a sequence” means two or more consecutive amino acids/nucleotides and not the entirety of the sequence.
Qiu teaches the Synechocystis 6803 has six putative porin proteins, Sll0772, Sll1271, Sll1550, Slr0042, Slr1908, and Slr1841 (all comprising SLH domains) were tested for knock out and knock down wherein four (sll0772, sll1271, sll1550 and slr0042) of the six proteins were successfully suppressed or completely inactivated (Page 7, Paragraph 2). Qiu teaches the TonB proteins have a cytoplasmic transmembrane domain in the N terminus which serves as a cytoplasmic membrane anchor, a proline-rich elongated linker that allows them to span the periplasmic space, and antiparallel β-sheets in the C terminus that may interact with the TonB box domain of TBDTs (Page 3, Paragraph 2). The Genbank accession number is cited as evidence due to Qiu teaching the use of the highly conserved protein of slr1841 which was known in the art (GenBank Accession Number BAA17449.1; 2016). The sequence shown in GenBank Accession Number BAA17449.1 is 100% identical to instant SEQ ID NO: 1 (See NEW Appendix I). The NCBI Reference sequence is cited as evidence due to Qiu teaching the use of the highly conserved protein of slr1841 which was known in the art wherein the protein is encoded by the slr1841 gene (NCBI Reference Sequence: NC_000911.1; 2019). The sequence shown in NCBI Reference Sequence: NC_000911.1 at nucleotide positions 958137 to 960029 of the complete genome of Synechocystis sp. PCC 6803 is 100% identical to instant SEQ ID NO: 7 (See NEW Appendix II).
Claim Rejections - 35 USC § 102
The previous rejection of claims 1-12 under 35 U.S.C. 102(a)(1) have been withdrawn in view of Applicant’s amendments to the claims filed on 04/06/2026.
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 13 and 14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of copending Application No. 17/845,022 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-8 of ‘022 application teaches the SEQ ID NOs: 1, 4, 7 and 10 of the instant application denoted as SEQ ID NOs: 1, 4, 7 and 10 for the purpose of a modified cyanobacterium where the proteins encoded by any of SEQ ID NOs: 1, 4, 7 and 10 is involved in binding between an outer membrane and a cell of cyanobacterium that is suppressed or lost.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 13 and 14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4-10 of copending Application No. 17/748,678 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1 and 4-10 of ‘678 application teaches the SEQ ID NOs: 1, 4, 7 and 10 of the instant application denoted as SEQ ID NOs: 1, 4, 7 and 10 for the purpose of a modified cyanobacterium where the proteins encoded by any of SEQ ID NOs: 1, 4, 7 and 10 is involved in binding between an outer membrane and a cell of cyanobacterium that is suppressed or lost.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 13 and 14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of copending Application No. 18/339,501 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-8 of ‘501 application teaches the SEQ ID NOs: 1, 4, 7 and 10 of the instant application denoted as SEQ ID NOs: 1, 4, 7 and 10 for the purpose of a modified cyanobacterium where the proteins encoded by any of SEQ ID NOs: 1, 4, 7 and 10 is involved in binding between an outer membrane and a cell of cyanobacterium that is suppressed or lost.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 13 and 14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of copending Application No. 18/456,037 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-8 of ‘037 application teaches the SEQ ID NOs: 1, 4, 7 and 10 of the instant application denoted as SEQ ID NOs: 1, 4, 7 and 10 for the purpose of a modified cyanobacterium where the proteins encoded by any of SEQ ID NOs: 1, 4, 7 and 10 is involved in binding between an outer membrane and a cell of cyanobacterium that is suppressed or lost.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 13 and 14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of copending Application No. 17/845,022 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-8 of ‘022 application teaches the SEQ ID NOs: 1, 4, 7 and 10 of the instant application denoted as SEQ ID NOs: 1, 4, 7 and 10 for the purpose of a modified cyanobacterium where the proteins encoded by any of SEQ ID NOs: 1, 4, 7 and 10 is involved in binding between an outer membrane and a cell of cyanobacterium that is suppressed or lost.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 13 and 14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims | and 4-10 of copending Application No. 18/456,897 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1 and 4-10 of ‘897 application teaches the SEQ ID NOs: 1, 4, 7 and 10 of the instant application denoted as SEQ ID NOs: 1, 4, 7 and 10 for the purpose of a modified cyanobacterium where the proteins encoded by any of SEQ ID NOs: 1, 4, 7 and 10 is involved in binding between an outer membrane and a cell of cyanobacterium that is suppressed or lost.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 13 and 14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of copending Application No. 18/457,500 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-8 of ‘500 application teaches the SEQ ID NOs: 1, 4, 7 and 10 of the instant application denoted as SEQ ID NOs: 1, 4, 7 and 10 for the purpose of a modified cyanobacterium where the proteins encoded by any of SEQ ID NOs: 1, 4, 7 and 10 is involved in binding between an outer membrane and a cell of cyanobacterium that is suppressed or lost.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 13 and 14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of copending Application No. 18/458,443 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-8 of ‘443 application teaches the SEQ ID NOs: 1, 4, 7 and 10 of the instant application denoted as SEQ ID NOs: 1, 4, 7 and 10 for the purpose of a modified cyanobacterium where the proteins encoded by any of SEQ ID NOs: 1, 4, 7 and 10 is involved in binding between an outer membrane and a cell of cyanobacterium that is suppressed or lost.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 13 and 14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of copending Application No. 18/974,875 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-10 of ‘875 application teaches the SEQ ID NOs: 1, 4, 7 and 10 of the instant application denoted as SEQ ID NOs: 1, 4, 7 and 10 for the purpose of a modified cyanobacterium where the proteins encoded by any of SEQ ID NOs: 1, 4, 7 and 10 is involved in binding between an outer membrane and a cell of cyanobacterium that is suppressed or lost.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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 ALEXANDRA ROSE LIPPOLIS whose telephone number is (703)756-5450. The examiner can normally be reached Monday-Friday, 8:00am to 5:00pm EST.
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, JENNIFER A DUNSTON can be reached at (571) 272-2916. 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.
/ALEXANDRA ROSE LIPPOLIS/Examiner, Art Unit 1637
/CELINE X QIAN/Primary Examiner, Art Unit 1637
Prosecution Insights