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 .
Applicant's response to the previous Office action, dated June 16, 2026, has been received. By way of this submission, Applicant has amended claims 1, 3-5, 19, 27, 31, and 32, and cancelled claim 2.
Claims 1, 3-5, 19-27, 29-32, and 43-45 are pending in the application. Claims 19-27, 29-32, and 43 remain withdrawn from consideration, pursuant to the Restriction Requirement mailed November 5, 2025.
Claims 1, 3-5 and 44-45 are therefore under examination before the Office.
The rejections of record can be found in the previous Office action, dated March 18, 2026.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on June 16, 2026 was filed after the mailing date of the first Office action on the merits on March 18, 2026. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 and 3-5 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.
Applicant argues that the claims as amended are directed to a more limited subset of sequences that are also operably linked to the constitutive promoter of a lactic acid bacteria, and that the skilled artisan would readily conclude that the Applicant was in possession of the presently claimed subject matter.
Applicant's arguments in view of the amendments to the claims have been considered fully but are not found to be persuasive.
A claim to a genus requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can 'visualize or recognize' the members of the genus. Ariad Pharm., Inc. V. Eli Lilly & Co., 598 F.3d 1336, 1353-54 (Fed. Cir. 2010) (en banc).
In the instant case, the claims are drawn to a heme-responsive promoter sequence comprising a nucleic acid sequence at least 85% homologous to SEQ ID NO: 104. As SEQ ID NO: 104 comprises 190 base pairs, the claim allows up to 28 possible base pair alterations, without restriction or limitation to their location or nature. This results in a vast genus of well in excess of a decillion possible sequences, not all of which would possess the claimed function. Of this genus, Applicant has disclosed four. This is not nearly enough to show possession of the entire genus.
A "representative number of species" means that those species that are adequately described are representative of the entire genus. AbbVie Deutschland GMBH V. Janssen Biotech, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014). Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
Mutations in promoter sequences can have significant impact on sequence functionality. For example, de Vooght (Clin Chem. 2009 Apr;55(4):698-708, cited previously) teaches that mutations in the promoter region of a gene may disrupt the normal processes of gene activation by disturbing the ordered recruitment of transcription factors at the promoter, vastly altering gene expression, and such mutations in a promoter may cause small quantitative defects, which may be hard to detect. Even if the promoter of an autosomal gene is completely downregulated as result of mutation, half of the normal amount of protein is present, which is often enough to prevent severe disease. This demonstrates a lack of a structure/function correlation between sequence and functionality of a promoter. Applicant has not offered any indication or guidance as to which structures or sequences are required for the claimed sequence to possess the claimed function of being responsive to heme.
For this reason, the skilled artisan would not have been in possession of the vast repertoire of sequences encompassed by the claimed invention; one of skill in the art would conclude that applicant was not in possession of the structural attributes of a representative number of species possessed by the members of the genera of heme-responsive promoter sequence broadly encompassed by the claimed invention. One of skill in the art would conclude that the specification fails to disclose a representative number of species to describe the claimed genera.
This rejection is therefore maintained.
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 45 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. This is a new grounds of rejection.
Claim 45 recites that “the nucleic acid sequence comprises a sequence as set forth in SEQ ID NO: 104.” As there is only one sequence listed, the claim should recite that “the nucleic acid sequence comprises the sequence…” Correction is required.
Claim Rejections - 35 USC § 102
Claims 1-4 were previously rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Debnath (WO2018183685A1).
Applicant argues that Debnath does not teach every aspect of the claims as amended; specifically, Debnath does not teach a sequence with at least 85% identity to SEQ ID NO: 104.
Applicant's arguments in view of the amendments to the claims has addressed this issue, and this rejection is hereby withdrawn.
Claim Rejections - 35 USC § 103
Claims 1-5 were previously under 35 U.S.C. 103 as being unpatentable over Lu (US20170058282A1, cited in IDS) in view of Debnath (WO2018183685A1).
Applicant argues that neither Lu nor Debnath teaches every aspect of the claims as amended; specifically, Lu and Debnath do not teach a sequence with at least 85% identity to SEQ ID NO: 104. Applicant further argues that neither reference provides the requisite motivation that would have led a person of ordinary skill in the art to modify the disclosed systems to arrive at the claimed invention.
Applicant's arguments in view of the amendments to the claims has addressed this issue, and this rejection is hereby withdrawn.
Allowable Subject Matter
Claim 44 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
No claim is allowed.
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/PETER JOHANSEN/Examiner, Art Unit 1644
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