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 .
Application Status
Receipt is acknowledged of amendment, filed 08/25/2023. Claims 1-10 are currently pending.
Election/Restrictions
Applicant’s election without traverse of Group I, drawn to claims 1-8, as well as election of SEQ ID NO: 1 or a protein having at least 50% identity thereto as the species in the reply filed on 11/19/2025 is acknowledged.
Claims 9 and 10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/19/2025.
Claims 4 and 8 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/19/2025.
Claims 1-3 and 5-7 are currently under examination.
Priority
Acknowledgement of the receipt of the certified foreign priority application, however, the document is not in English. Therefore, all claims are given the effective filing date of 03/01/2022, filed as PCT/JP2022/008657.
All claims are given the priority date of 03/01/2022 until the certified foreign priority is provided in English.
Information Disclosure Statement
Receipt of acknowledgment of the information disclosure statement filed on 08/25/2023 has been received and all references have been considered.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
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 1-3 and 5-7 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 a modified cyanobacterium in which a total amount of a protein involved in binding between an outer membrane and a cell wall of cyanobacterium is suppressed to at least 30 percent and at most 70 percent of a total amount of the protein in a parent strain wherein the protein is an SLH-domain containing outer membrane protein or gene in which the sequence comprises 100% identity to any of SEQ ID NOs: 1-3 or 7-9 and/or the protein is a cell wall-pyruvic acid modifying enzyme or gene in which the sequence comprises 100% identity to any of SEQ ID NOs: 4-6 or 10-12, does not reasonably provide enablement for a modified cyanobacterium in which a total amount of a protein involved in binding between an outer membrane and a cell wall of cyanobacterium is suppressed to at least 30 percent and at most 70 percent of a total amount of the protein in a parent strain wherein the protein has an amino acid sequence that is less than 100% identical to the amino acid sequence of any one of the Slr1841, the NIES970_09470, the Anacy_3458, the Slr0688, the Synpcc7942_1529, and the Anacy_1623, the protein corresponding to a gene having a nucleotide sequence that is less than 100% identical to the nucleotide sequence of any one of the s1r1841, the nies970_09470, the anacy_3458, the s1r0688, the synpcc7942_1529, and the anacy_1623 as well as any protein not provided within the current specification. 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 total amount of a protein involved in binding between an outer membrane and a cell wall of cyanobacterium is suppressed to at least 30 percent and at most 70 percent of a total amount of the protein in a parent strain. Specifically, dependent claims 3 and 7 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. In order to determine other SLH-domain containing outer membrane proteins that would be encompass the limitation of “a protein involved in binding between an outer membrane and a cell wall of cyanobacterium that is suppressed to at least 30 percent and at most 70 percent of a total amount of the protein in a parent strain” would require testing to identify the protein as well as screening to determine the degree in which it is suppressed.
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. Finally, following the testing to determine the SLH-domain containing outer membrane protein and/or the cell wall-pyruvic acid modifying enzyme capable of successfully causing separation of the cell wall from the outer-membrane of the cyanobacteria, screening to determine the degree in which it is suppressed would still need to be performed. Therefore, experiments 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 1-3, 5-7 are not considered to be fully enabled by the instant disclosure.
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.
Claims 3 and 7 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.
Claims 3 and 7 are vague and indefinite in that the metes and bounds of the phrase “an amino acid sequence represented by SEQ ID NO:” are unclear. The phrase is unclear in that “represented by” can mean that the amino acid sequence can be the SEQ ID NOs listed or by another amino acid sequence. There is no definition in the instant specification of “represented by”, therefore the definition is interpreted by its broadest reasonable interpretation that “represented by” means constituted by or amount to. This definition of the phrase means other sequences with reasonable similarity can constitute the sequence. It would be remedial to replace the phrase “an amino acid sequence represented by SEQ ID NO:” with “an amino acid sequence of SEQ ID NO:”.
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.
Claims 1, 2, 5 and 6 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).
Regarding claim 1, 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 porin knockdown strain showed 68% less production compared to the wild-type strain (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).
Regarding claim 2, 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 of the six proteins were successfully suppressed or completely inactivated (Page 7, Paragraph 2).
Regarding claims 5 and 6, Qiu teaches knocking out the slr1484 gene by inserting a kanamycin-resistant cassette fragment CK2 (Page 3, Paragraph 5).
Claims 1-3 and 5-7 are rejected under 35 U.S.C. 102(a)(1) as being unpatentable over Kojima et al (BioRxiv, March 25, 2020; Pages 1-31) and as evidenced by Accession Number P73409 (strain PCC 6803; 2006) and Synechocystis sp. PCC 6803 DNA, complete genome (GenBank Accession Number NC_000911.1; 2016).
Applicant cannot rely upon the certified copy of the foreign priority application to overcome this rejection because a translation of said application has not been made of record in accordance with 37 CFR 1.55. When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP §§ 215 and 216.
Regarding claims 1-3, Kojima teaches producing a modified cyanobacterium, PCC 6803, by repressing the slr1841 protein (Page 7, Lines 121-148). Kojima teaches the repression of Slr-1841 exhibits outer membrane detachment by loss of linkage to the peptidoglycan while maintaining Slr1841 protein levels for the purpose of photoautotrophic growth (Page 7, Lines 121-148). Kojima teaches SDS-PAGE analysis revealed that in this system, the levels of Slr1841, Slr1908, and Slr0042 proteins were reduced by >50%, compared with the control strain whose chromosomal DNA harbors the same genetic construct without sgRNA (ΔsgRNA) (Page 7, Lines 133-135). The GenBank accession numbers are cited to show that the slr1841 protein is a protein within the Synechocytis cyanobacteria genome. Accession number P73409 is 100% identical to SEQ ID NO: 1 (See the alignment in Appendix I).
Regarding claims 5 and 6, Kojima teaches a CRISPR interference (CRISPRi) system was employeed in which nuclease-deficient Cas9 (dCas9) and single guide RNA (sgRNA) form a complex that binds to a target gene, thereby inhibiting its transcription (Page 7, Lines 129-131). Kojima teaches the repression of Slr-1841 exhibits outer membrane detachment by loss of linkage to the peptidoglycan while maintaining Slr1841 protein levels for the purpose of photoautotrophic growth (Page 7, Lines 121-148).
Regarding claim 7, Kojima teaches the repression of Slr-1841 exhibits outer membrane detachment by loss of linkage to the peptidoglycan while maintaining Slr1841 protein levels for the purpose of photoautotrophic growth (Page 7, Lines 121-148). The GenBank accession numbers are cited to show that the slr1841 protein is a protein within the Synechocytis cyanobacteria genome. Accession number P73409 is 100% identical to SEQ ID NO: 1 (See the alignment in Appendix I). SEQ ID NO: 1 is the amino acid translation of the nucleotide sequence presented in SEQ ID NO: 7 as shown in the full genome sequence of Synechocystis sp. PCC 6803 provided by GenBank Accession number NC_000911.1 such that SEQ ID NO: 1 starts at position 958137 to 960026 (See the alignment in Appendix II) and SEQID NO: 7 is the nucleotide sequence of the full genome starting at position 958137 to 959488 (See the alignment in Appendix III).
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 1-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 9-11 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 9-11 of ‘022 application teaches the SEQ ID NOs: 1-12 of the instant application denoted as SEQ ID NOs: 1-12 for the purpose of a modified cyanobacterium where the proteins encoded by any of SEQ ID NOs: 1-12 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 1-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7-10 and 17 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, 7-10 and 17 of ‘678 application teaches the SEQ ID NOs: 1-12 of the instant application denoted as SEQ ID NOs: 1-12 for the purpose of a modified cyanobacterium where the proteins encoded by any of SEQ ID NOs: 1-12 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 1-8 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: 1-12 of the instant application denoted as SEQ ID NOs: 1-12 for the purpose of a modified cyanobacterium where the proteins encoded by any of SEQ ID NOs: 1-12 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 1-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 and 11 of copending Application No. 17/748,617 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-8 of ‘617 application teaches the SEQ ID NOs: 1-12 of the instant application denoted as SEQ ID NOs: 1-12 for the purpose of a modified cyanobacterium where the proteins encoded by any of SEQ ID NOs: 1-12 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 1-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 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: 1-12 of the instant application denoted as SEQ ID NOs: 1-12 for the purpose of a modified cyanobacterium where the proteins encoded by any of SEQ ID NOs: 1-12 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 1-8 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: 1-12 of the instant application denoted as SEQ ID NOs: 1-12 for the purpose of a modified cyanobacterium where the proteins encoded by any of SEQ ID NOs: 1-12 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 1-8 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: 1-12 of the instant application denoted as SEQ ID NOs: 1-12 for the purpose of a modified cyanobacterium where the proteins encoded by any of SEQ ID NOs: 1-12 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 1-8 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: 1-12 of the instant application denoted as SEQ ID NOs: 1-12 for the purpose of a modified cyanobacterium where the proteins encoded by any of SEQ ID NOs: 1-12 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
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/ALEXANDRA ROSE LIPPOLIS/Examiner, Art Unit 1637
/CELINE X QIAN/Primary Examiner, Art Unit 1637