NOVEL PROMOTER

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 papers filed 01/29/2025. Claims 1-9 are pending in the application as set forth in the claim set filed 01/29/2025. Therefore, claims 1-9 are examined on the merits. At least claims 1, 4, 6, 7 and 9 are independent claims. Priority The present application is a 35 U.S.C. 371 national stage filing of International Application No. PCT/JP2022/030912 filed 08/15/2022. Thus, the earliest possible priority for the instant application is August 15, 2022. Claim objection Claim 1 is objected to because the recitation of “DNA comprising” in subparts (1)-(4) should be preceded by the indefinite article “a”. Appropriate correction is requested. 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. Claims 7-9, 11, 13, 16 and 19-21 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 applicant regards as the invention. Claim 1 subparts (1)-(4) recite “represented by any one of SEQ ID NOs: 1 to 3”. The specification does not provide any closed definition as to what is meant by “represented by”. It is unclear if the phrase “represented by” should be interpreted narrowly to encompass only materials that have a structure identical to the SEQ ID NO: or if the phrase should be interpreted broadly to encompass materials which have a structure “similar” to the SEQ ID NO:, for example, the same gene from another species. The metes and bounds are not clearly set forth. Claim 1 is indefinite in its recitation of” a base sequence that hybridizes with a base sequence complementary…. Under stringent condition”. The art recognizes that stringent or stringency are relative terms and there is no art accepted definition such that one of skill of the art can readily envision what is encompassed by “stringent conditions” so at to avoid infringement. As such the metes and bounds of the claims are indefinite. 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 1-9 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. In analyzing whether the written description requirement is met for genus claims, it is first determined whether a representative number of species have been described by their complete structure. To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof. The disclosure of a single species is rarely, if ever, sufficient to describe a broad genus, particularly when the specification fails to describe the features of that genus, even in passing. (see In re Shokal 113USPQ283(CCPA1957); Purdue Pharma L.P. vs Faulding Inc. 56 USPQ2nd 1481 (CAFC 2000). The court explained that “reading a claim in light of the specification, to thereby interpret limitations explicitly recited in the claim, is a quite different thing from ‘reading limitations of the specification into a claim,’ to thereby narrow the scope of the claim by implicitly adding disclosed limitations which have no express basis in the claim.” The court found that applicant was advocating the latter, i.e., the impermissible importation of subject matter from the specification into the claim.). See also In re Morris, 127 F.3d 1048, 1054-55, 44 USPQ2d 1023, 1027-28 (Fed. Cir. 1997). Claim 1 recites “DNA comprising a base sequence having substitution, addition, or deletion of one or more bases in the base sequence represented by any one of SEQ ID NO: 1-3, and having promoter activity” (claim 1 (2) and “DNA comprising a base sequence having 90% or more identity to the base sequence represented by any one of SEQ ID NO: 1-3, and having promoter activity.” (claim 1 (3) and “a base sequence that hybridizes with a base sequence complementary to the base sequence represented by any one of SEQ ID NOs: 1 to 3 under stringent conditions” (claim 1 (4). Applicant’s specification only discloses SEQ ID NO:1-3 as promoters of the invention. SEQ ID NO:1 is 1069 nucleotides long. SEQ ID NO: 2 is 1069 nucleotides long. SEQ ID NO: 3 is 1070 nucleotides long. Claim 1 recites at least 90% identity to SEQ ID NO:1-3. Thus, the claims reasonably encompass as many as 107 nucleic acid substitutions, insertions, or deletions. (4)107 = is about 2x1064 possible variants of SEQ ID NO:1-3 having at least 90% sequence identity to SEQ ID NO: 1-3. However, the specification only discloses SEQ ID NO:1-3. Thus, it is immediately apparent to the ordinary artisan that the instant claims are vastly broader in scope to Applicant’s actual invention, SEQ ID NOs: 1-3, for encompassing an enormously vast genus of about 2x1064 variants structurally and functionally undisclosed variants of SEQ ID NO:1 that are to have the functional property of driving expression of an exogenous gene in a retinal ganglion cell. The Federal Circuit has explained that a specification cannot always support expansive claim language and satisfy the requirements of 35 U.S.C. 112 “merely by clearly describing one embodiment of the thing claimed.” LizardTech v. Earth Resource Mapping, Inc., 424 F.3d 1336, 1346, 76 USPQ2d 1731, 1733 (Fed. Cir. 2005). For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. See, e.g., Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. Instead, the disclosure must adequately reflect the structural diversity of the claimed genus, either through the disclosure of sufficient species that are “representative of the full variety or scope of the genus,” or by the establishment of “a reasonable structure-function correlation.” Such correlations may be established “by the inventor as described in the specification,” or they may be “known in the art at the time of the filing date.” See AbbVie, 759 F.3d at 1300-01, 111 USPQ2d 1780, 1790-91 (Fed. Cir. 2014) Applicant’s specification fails to disclose a reduction to practice modifying and/or deleting 5, 10, 15, 20, 25, 50, or as many as 100 nucleotides (90% identity) of SEQ ID NOs:1-3, thereby generating an enormously vast genus of about 2x1064 variants of SEQ ID NOs:1-3 that are to have the function of promoter activity in a cell. The claims fail to recite, and the specification fails to disclose, the structure/function nexus of the enormously vast genus of about 2x1064 variants of SEQ ID NOs:1-3 that are to have the functional property of driving expression of an exogenous gene in a retinal ganglion cell. Applicant’s specification fails to disclose the common, core nucleotide sequences shared by the enormously vast genus of 2x1064 variants of SEQ ID NOs:1-3 that necessarily and predictably achieve the functional property of driving expression/having promoter activity. In terms of the structural requirements of the nucleic acid molecules, claim 1(4) recites an arbitrary structural relationship between the claimed nucleic acid sequence(s) and the single disclosed species of nucleotide sequence identified as SEQ ID NOs:1-3, based upon hybridization of nucleic acid. Hybridization of two nucleic acids, even under high stringency conditions, requires only that the two nucleic acids share between 25 and 50 nucleotides in common. See Kennell, Progr. Nucleic Acid Res. Mol. Biol. 11: 259-301, 1971 at the paragraph bridging pages 260-261. Thus, the recited structural relationship is arbitrary since neither the specification, nor the prior art discloses any definitive relationship between promoter activity and % identity or homology at the nucleotide level; and the specification does not describe a single species of nucleic acid that that is not either 100% identical to SEQ ID NOs:1-3 having promoter activity. Rather, Applicant’s working example(s) are directed to the use of a nucleotide sequence that is 100% identical to SEQ ID NOs: 1-3. Without a correlation between structure and function, the claim does little more than define the claimed invention by function. That is not sufficient to satisfy the written description requirement. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406 (“definition by function … does not suffice to define the genus because it is only an indication of what the gene does, rather than what it is”). Accordingly, this limited information is not deemed sufficient to reasonably convey to one skilled in the art that the applicant is in possession of the enormously vast genus of about 2x1064 structurally and functionally undisclosed variants of SEQ ID NOs:1-3 having only 90% identity to SEQ ID NOs:1-3 and that necessarily and predictably have the functional property of driving expression/have promoter activity. Thus, for the reasons outlined above, it is concluded that the claims do not meet the requirements for written description under 35 U.S.C. 112, first paragraph. Dependent claims are included in the basis of the rejection because they do not correct the primary deficiencies of the independent claim(s). Allowable Subject Matter The nucleotides of SEQ ID NO: 1-3 are free of the prior art. Conclusion Claims 1-9 are rejected. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDRA CONNORS whose telephone number is (571)272-7010. The examiner can normally be reached Monday - Friday (9AM-5PM). 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, MARIA LEAVITT can be reached at (571) 272-1085. 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 F CONNORS/Examiner, Art Unit 1634 /MARIA G LEAVITT/Supervisory Patent Examiner, Art Unit 1634