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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 63-73) and the species (i) light absorbing substance which is a chimeric protein or a nucleic acid encoding the same, and (ii) an opsin which is a microbial opsin in the reply filed on 3/9/2026 is acknowledged. Upon search consideration, the examiner has withdrawn species election within Group I, and therefore, claims 63-73 are under consideration.
The requirement is still deemed proper and is therefore made FINAL.
Status of Application, Amendments, And/Or Claims
Claims 63-82 are pending.
Claims 74-82 are withdrawn for being drawn to non-elected inventions (i.e., Groups 2-5).
Claims 63-73 are under examination.
Information Disclosure Statement
The Information Disclosure Statements (IDSs) filed on 3/17/2023 and 5/29/2024 have been considered.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
The instant application is a 371 of PCT/JP2021/034143 filed on 9/16/2021.
Title
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed. The title recites “COMPOSITION FOR TREATING OR PREVENTING DISEASES, DISORDERS, OR CONDITIONS ASSOCIATED WITH ENDOPLASMIC RETICULUM STRESS OR ALL-TRANS-RETINAL, PROTECTING RETINAL THICKNESS, OR SUPPRESSING REDUCTION IN RETINAL THICKNESS OR PROGRESS OF REDUCTION IN RETINAL THICKNESS”. The following title, for example, is suggested: A METHOD OF TREATING A RETINAL DISEASE COMPRISING ADMINISTERING …..., or something
like.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (see pg. 59, line 7). 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.
Drawings
New corrected drawings in compliance with 37 CFR 1.121(d) are required in this application because Figure 1C-D, Figure 4D are not legible . Applicant is advised to employ the services of a competent patent draftsperson outside the Office, as the U.S. Patent and Trademark Office no longer prepares new drawings. The corrected drawings are required in reply to the Office action to avoid abandonment of the application. The requirement for corrected drawings will not be held in abeyance.
Claim Rejections - 35 USC § 102
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.
Claim(s) 63-73 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kurihara et al. (IDS, WO 2020/148913).
The instantly claimed invention is broadly drawn to a method for reducing or eliminating an endoplasmic reticulum stress in a subject in need thereof, the method comprising the step of administering an effective amount of a light absorbing substance to the subject (claim 63), wherein the light absorbing substance modulates the cis/trans retinal ratio in a subject of interest (claim 64), wherein the light absorbing substance modulates a retinal concentration in a subject of interest (claim 65), characterized by administering the light absorbing substance to the subject prior to or after onset of a disease, disorder or symptom stress (claim 66), characterized by administering the light absorbing substance once during a treatment period (claim 67), wherein the light absorbing substance is a chimeric protein comprising an ion-transporting receptor rhodopsin and a G protein-coupled receptor rhodopsin, a vertebrate non-visual opsin, an invertebrate opsin, or a microbial opsin (claim 70), wherein the light absorbing substance comprises a microbial opsin (claim 71), wherein the ion-transporting receptor rhodopsin is derived from cyanobacteria (blue-green bacteria) (claim 72), and wherein the G protein-coupled receptor rhodopsin is derived from a mammal (claim 73).
Kurihara et al. teach a method of treating retinal diseases comprising administering a two types of rhodopsin, an ion transport type and a G-protein-coupled receptor (see abstract, also see subtitle: Chimera rhodopsin) and a nucleic acid sequence encoding the same. Regarding claims 64 and 65, the limitations are inherent feature of the light absorbing substance rhodopsin (it is well known in the art that rhodopsin is an opsin as evidence by WO 2019077159, pg. 8, second paragraph), unless evidence to contrary. It is noted that WO 2019077159 is applied to support the state of the art and not as a prior art. Kurihara et al. teach the light absorbing rhodopsin can be from microorganism, for example cynobacteria (see subtitle: Chimera rhodopsin, claim 12). They teach a nucleic acid sequence comprising the same (claim 11). Regarding claim 69, Kurihara et al. teach the chimeric protein of claim 63 that would implicitly meet the limitation of claim 68. They teach a method of treating retinal diseases comprising administering a light absorbing substance to a subject in need thereof, wherein the said is a chimeric protein comprising an ion transporter type rhodopsin and a GPCR or a nucleic acid sequence comprising the same (see claims 17, 41). Regarding claim 66, they teach administering the composition to the subject before, or immediately after the onset of the disease (see claim 8). Regarding claim 67, they teach administering the composition once during a treatment (claim 9). Therefore, the instantly claimed invention is implicitly or explicitly taught by the prior art of record.
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 63-73 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 method of treating a retinal disease in a subject in need thereof comprising administering an effective amount of a light absorbing substance wherein the substance is a chimeric rhodopsin, does not reasonably provide enablement for treating or eliminating any endoplasmic reticulum stress in a subject in need thereof comprising an effective amount of any light absorbing substance. 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.
In In re Wands, 8USPQ2d, 1400 (CAFC 1988) page 1404, the factors to be considered in determining whether a disclosure would require undue experimentation include: (1) Nature of the invention, (2) the state of the prior art, (3) the predictability or lack thereof in the art, (4) the amount of direction or guidance present, (5) the presence or absence of working examples, (6) the breath of the claims, (7) the quantity of experimentation needed, (8) relative skill of those in the art.
The instant disclosure fails to meet the enablement requirement for the following reasons:
The instant claims are broadly drawn to a reducing or eliminating any endoplasmic reticulum stress in a subject in need thereof comprising administering an effective amount of any light absorbing to the subject in need thereof.
The state of the prior art and the predictability or lack thereof in the art:
With regards to the eliminating or reducing endoplasmic reticulum stress in a subject in need thereof, the specification does not disclose sufficient guidance or objective evidence that such composition would any reticulum stress that may include Alzheimer’s disease, Parkinson’s disease, prion disease, amyotrophic lateral sclerosis (ALS) in a subject need thereof. Ichijyo et al. (WO 0238179) teach that endoplasmic reticulum stress is caused by accumulation of abnormal proteins aggregate and include neurodegenerative disease typified by polyglutamine disease, Alzheimer’s disease, Parkinson’s disease, Prion disease, amyotrophic lateral sclerosis (ALS) ), FTDP-17 (anterotemporal dementia linked to chromosome 17), and other neurodegenerative diseases (page 1). . Ichijyo et al. teach that ASK1 is a kind of kinase belonging to MAPKK kinase family which is activated by TNF via TNF receptor. Ichijyo et al. that inhibition of ASK1 could be a useful agent for neurodegenerative diseases but art does not suggest that use of a light absorbing substance can eliminate or reduce any reticulum stress. Therefore, it is unpredictable and would require a large amount of experimentation to eliminate or reducing any endoplasmic reticulum stress associated diseases comprising a light absorbing substance in a subject in need thereof.
The amount of direction and guidance present and the presence or absence of working examples: Given the teachings found in the art, detailed teachings are required to be present in the disclosure in order to enable the skilled artisan to practice the invention as claimed. These teachings are absent. The specification of pages 103-108 disclose preparing a viral vector comprising for expressing a chimeric protein (Example 1) and evaluation of light absorbing substance or retinal degeneration (Example 15). The specification does not teach administering any chimeric protein comprising an ion-transforming receptor rhodopsin and GPCR rhodopsin that can inhibit or eliminate any endoplasmic reticulum stress in a subject in need thereof. The art or the specification is devoid of any example where the administration of a chimeric protein comprising an ion-transforming receptor rhodopsin and GPCR rhodopsin can eliminate endoplasmic reticulum stress in a subject in need thereof. Therefore, it is unpredictable how one of the skill in the art can practice the instantly claimed invention.
The breadth of the claims and the quantity of experimentation needed: Due to the large quantity of experimentation necessary to inhibit or eliminate any endoplasmic reticulum stress (including, but not limited to, polyglutamine disease, Alzheimer’s disease, Parkinson’s disease, Prion disease, amyotrophic lateral sclerosis (ALS) ), FTDP-17 (anterotemporal dementia linked to chromosome 17) comprising administering a light absorbing substance in a subject in need thereof, the lack of direction/guidance presented in the specification regarding the same, the state of the prior art which establishes the unpredictability about eliminating any endoplasmic reticulum stress to subject in need thereof, undue experimentation would be required of the skilled artisan to make and/or use the claimed invention in its full scope.
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 63-65, 70-71 and 73 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1,12 and 14-16 of U.S. Patent No. 11,771,741. Although the claims at issue are not identical, they are not patentably distinct from each other because a method of treating a retinal disease comprising a nucleic acid sequence or a polypeptide encoded by a nucleic acid, wherein the polypeptide is rhodopsin. The instant claims do not require that the nucleic acid sequence comprises a sequence of SEQ ID NO: 26.
Claims 63-65, and 67-73 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 43-49, and 51 of copending Application No. 19239,026 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because a method of treating a retinal disease comprising administering a chimeric protein comprising ion-transporting rhodopsin and a GPCR rhodopsin, wherein the rhodopsin is derived from cyanobacteria, wherein the GPCR rhodopsin is derived from a mammal and a nucleic acid sequence encoding the same are taught in claims 43-49 and 51 of US Application No. 19/239,026.
Claims 63-65, 68-71 and 73 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7, 13, 19, 26, 28, 33-36 of copending Application No. 17/642,923 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because a nucleic acid encoding a light absorbing substance, wherein the light absorbing substance is a chimeric protein is rhodopsin and a pharmaceutical composition comprising the same for treating a retinal disease are taught by claims 1, 7, 13, 19, 26, 28, 33-36 of copending Application No. 17/642,923.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GYAN CHANDRA whose telephone number is (571)272-2922. The examiner can normally be reached Mon-Friday 8:30AM-5:00P.
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/GYAN CHANDRA/Primary Examiner, Art Unit 1674
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