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 .
Status of Application/Election/Restrictions
Applicant’s election without traverse of Group II (claims 16-18) in the reply filed on 8/7/2026 is acknowledged.
Claims 9-19 are pending. Claims 9-15 and 19 are currently withdrawn from further consideration pursuant to 37 CFR 1.142 (b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 16-18 are the subject of the present Official action.
Priority
Applicant’s claim for the benefit of a prior-filed application JP2016-172149, PCT/JP2017/031579 and CON of 16/329,631 filed on 9/2/2016, 9/1/2017 and 2/28/2019 respectively, under 35 U.S.C 119(e) or under 35 U.S.C 120, 121 or 365(c) is acknowledged.
Accordingly, the effective priority date of the instant application is granted as 9/2/2016.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 2/16/2024, 2/21/2024, 2/27/2025 and 4/21/2026 were received. The submissions were in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements were considered by the examiner.
Claim Interpretation
Claims 16-18 describe a chimeric protein that optionally contains an amino acid sequence of a bovine or human derived G protein-coupled receptor rhodopsin. It is emphasized that claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure, see MPEP 2111.04. Thus, claims 16-18 are interpreted as broadly reading on an amino acid sequence of an ion transport receptor rhodopsin derived from a microorganism of the Gleobacter genus.
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 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 17-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sasaki et al. "Chimeric proton-pumping rhodopsins containing the cytoplasmic loop of bovine rhodopsin." PLoS One 9.3 (2014): e91323 (hereinafter Sasaki).
Claims 17-18: Sasaki describes the design of new chimeric proton-pumping rhodopsins with enhanced G-protein activating functions using Gloeobacter rhodopsin (GR) from thylakoidless cyanobacteria which have had their cytoplasmic loops replaced with bovine rhodopsin loops (Sasaki, abstract and discussion last para). Sasaki found that the GR chimeras which had their second and third cytoplasmic loops replaced with bovine rhodopsin loops exhibited enhanced G-protein activation (Sasaki, abstract). Sasaki outlines the design of chimeric GR in Fig 1, wherein BvRh second and third loop inserted chimeras can be observed (Sasaki, Fig 1). Sasaki describes cloning the full-length chimera into a vector and expressing the chimera in E. coli (Sasaki, Experimental Procedures- Sample Preparation). Sasaki states that all chimeras were confirmed by DNA sequencing, showing that both the nucleic acid and amino acid sequences were known (Sasaki, Experimental Procedures- Sample Preparation). Sasaki conducted numerous tests using FTIR spectroscopy and laser flash photolysis to characterize the light-induced enzymatic activity of the resulting GR chimeras (Sasaki, Figs 4, 6 and 8). Sasaki concludes that the novel chimeras would be useful as an optogenetic tool due to their enhanced G-protein activation (Sasaki, Discussion last para).
Claim Rejections - 35 USC § 103
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 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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Sasaki (supra) in view of Pan et al. US 2016/0038409, published 2/11/2016 (hereinafter Pan).
A description of Sasaki can be found above. Sasaki does not describe an AAV or lentivirus vector comprising a nucleic acid sequence that encodes the chimeric protein.
Claim 16: Pan describes methods for enhancing the delivery of therapeutic opsins to a subject’s eye as a treatment for various ocular diseases like retinitis pigmentosa (Pan, para 4, 9, 25, 83, 84). Pan provides specific embodiments for the delivery of channel rhodopsins as well as various chimeras thereof (Pan para 9, 62, 69, 70, 71 and claim 7). Pan provides express motivation for the restoration of photosensitivity or vision via the select expression of channel rhodopsins via gene therapy (Pan para 62, 69, 77). Pan describes gene delivery methods using viral vectors, including preferend embodiments to AAV viral vectors, which are able to express the chimeric rhodopsin throughout the ocular tissue (Pan, para 9, 14, 19, 41, 54).
It would have been prima facie obvious to one of ordinary skill in the art to deliver the chimeric GR disclosed by Sasaki using the AAV viral vector-based gene therapy methods described by Pan as a treatment for ocular diseases like retinitis pigmentosa. It would have been a matter of combining known methods to yield predictable results since Pan demonstrated the effective delivery of similar channel rhodopsins and chimeras. One would have been motivated to use the GR chimera disclosed by Sasaki in particular given its enhanced G-protein activating functions which would consequently lead to improved restoration of photosensitivity and vision in patients suffering from retinitis pigmentosa. One would have a reasonable expectation of success given the relative interchangeability of similar sized rhodopsin expression products in the viral vector systems disclosed by Pan. Accordingly, in the absence of evidence to the contrary, one of ordinary skill in the art would have considered the claimed invention to have been prima facie obvious to at the time the invention was made.
Nonstatutory 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 Langi, 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 706.02(1)(1) - 706.02(1)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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 autoprocessed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 16-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 43-55 of copending Application No: 19/239,026 (US Patent Application Publication Number US2022/0025018) in view of Sasaki et al. "Chimeric proton-pumping rhodopsins containing the cytoplasmic loop of bovine rhodopsin." PLoS One 9.3 (2014): e91323 (hereinafter Sasaki). Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims would anticipate the instant claims if they were available as prior art.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. The competing claims are drawn to compositions and methods for preventing the progression of a disease of the retina via the administration of a nucleic acid encoding a chimeric protein of an ion-transporting receptor rhodopsin and a G protein-coupled receptor rhodopsin. The copending claims describe a chimeric protein of an ion-transporting receptor rhodopsin for improving visual cognitive behavioral function. Although the copending claims are silent to a rhodopsin derived from a microorganism of the Gleobacter genus, it would have been prima facie obvious to one of ordinary skill in the art to select this rhodopsin variant in view of Sasaki who teaches that this particular GR chimera has enhanced G-protein activating functions which would consequently lead to improved restoration of photosensitivity and vision in patients suffering from retinitis pigmentosa. One would have a reasonable expectation of success given the relative interchangeability of similar sized rhodopsin expression products. Accordingly, in the absence of evidence to the contrary, one of ordinary skill in the art would have considered the claimed invention to have been prima facie obvious to at the time the invention was made.
Claims 16-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of US Patent No. 11,932,679. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims would anticipate the instant claims if they were available as prior art.
The patented claims are drawn to a method for treating or preventing retinal disease in a subject comprising administering an effective amount of a nucleic acid sequence encoding a chimeric protein comprising an amino acid sequence of an ion transport receptor rhodopsin derived from a microorganism of the Gleobacter genus and provides specific nucleic acid sequence embodiments SEQ ID NO: 1-3. The patented claims would anticipate the instantly claimed invention, which is drawn to a broadly recited composition which is administered in the claimed method, reciting a nucleic acid molecule encoding a chimeric protein of an ion transport receptor rhodopsin derived from a microorganism of the Gleobacter genus. The pending claims are thus much broader than the patented claims and are therefore patentably indistinct.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Dr. ALEXANDER NICOL whose telephone number is (571)272-6383. The examiner can normally be reached on M-F 8-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maria Leavitt can be reached on (571)272-1085. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Alexander Nicol
Patent Examiner
Art Unit 1634
/ALEXANDER W NICOL/Examiner, Art Unit 1634
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