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 with traverse of rejoining Group I and Group II in the reply filed on 10/30/2025 is acknowledged. The traversal is on the ground(s) that Groups I and II are linked through a structure-function relationship, in that structural integrity supports normal function while functional deficits reflect structural damage is found persuasive. Therefore claims examined are 1-2, 6-19, 20-23, 31-34, 37-46 and 54-55.
Claims 3-4, 24-30, 35-36, 47-53 and 56-57 withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 10/30/2025.
Applicant has canceled claim 5 and added claims 58-67, no new matter was added. Claims 1-2, 6-19, 20-23, 31-34, 37-46, 54-55 and 58-67 is now evaluated on its merits.
Claim Objections
Claims 60-61 and 65-66 are objected to because of the following informalities: A period at the end of the claim. Appropriate correction is required.
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 31 and 44 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.
Claim 31 and 44 contains the trademark/trade name Xiflam. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe the compound tonabersat and, accordingly, the identification/description is indefinite.
Claim Rejections - 35 USC § 103
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 1-2, 6-19, 20-23, 31-34, 37-46, 54-55 and 58-67 are rejected under 35 U.S.C. 103 as being unpatentable over Green et al. (US Patent No. 20160177298) in view of Nor et al. Sustained Connexin43 Mimetic Peptide Release From Loaded Nanoparticles Reduces Retinal and Choroidal Photodamage, Vision Science, May 2018, Pages 3682-3693.
Regarding claims 1-2, 6-19, 20-23, 31-34, 37-46, 54-55 and 58-67, Green teaches methods for treating ocular and other disorders, including age related macular degeneration (AMD), retinal ischemic diseases or ocular ischemic diseases (relevant to claims 37-38) comprising administration of a therapeutically effective amount of compounds of formula I
PNG
media_image1.png
822
309
media_image1.png
Greyscale
, in particular tonabersat (relevant to claims 1-2, 6-8, 20, 31, 34 and 54) (para. 0010, 0035-0036 and 0050). Of the tonabersat Green teaches the compound administered to a human by rote of injection or orally once a day or once a week at a dose of approximately 2 mg to approximately 40 mg, a dose range of approximately 0.1 to approximately 6 mg/kg/day and circulating concentration in the ranges of approximately 0.001 micromolar to approximately 200 micromolar (relevant to claims 9-17, 32-33, 44, 55) (para. 0015, 0245, 0511-0513 and 0523).
Green additionally teaches the compound may or may not be formulated into a microparticle (relevant to claim 18) (para. 0373) and administration of the above compound results in preventing retinal pigment epithelium degeneration associated with conditions of dry or wet AMD (relevant to claims (45, 58-62) (para. 0052) and reduce inflammation in the inner retina (relevant to claims 42, 63-67) (para. 0050).
Green fails to teach the compounds to treat ocular disorders wherein retinal vascular endothelium and normal retinal layer structure is recovered as well as restoring retinal functions of mixed a-wave function, mixed b-wave function and/or PII and PIII rod and cone function.
Nor teaches In AMD, local inflammation is associated with an immune cell–mediated process that leads to a chronic inflammatory environment. According to recent reports, the inflammatory reaction is associated with an increase in connexin43 (Cx43) expression and Cx43 also forms hemichannels in the plasma membrane. Thus administration of Cx43MP and Cx43MP-NP improved a-wave and b-wave function of the ERG, prevented photoreceptor, restoring PII and PIII rod and cone function (abstract, Pg. 3682, 3685).
Therefore it would have been obvious to someone of ordinary skill in the art at the time of filling to have administered the compound tonabersat to treat ocular disorders, wherein retinal vascular endothelium and normal retinal layer structure is recovered as well as restoring retinal functions of mixed a-wave function, mixed b-wave function and/or PII and PIII rod and cone function. One would have been motivated to do so from the teachings of Green of the ocular disorders leads to vascular endothelial growth and the teachings of Nor on treatment of AMD leads to improvement of b-wave function of the ERG and restoring PII and PIII rod and cone function. It is also noted from applicant the retinal function and structure are directly related, thus improvement in one directly improves the other. There is a reasonable expectation of restoring retinal vascular endothelium, normal retinal layer structure, retinal functions of mixed a-wave function, mixed b-wave function and/or PII and PIII rod and cone function by the administration of tonabersat taught by Green.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MIKHAIL O'DONNEL ROBINSON whose telephone number is (571)270-0777. The examiner can normally be reached Monday-Friday 7:30am-5:30pm.
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, Kortney Klinkel can be reached at 571-270-5239. 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.
MIKHAIL O'DONNEL. ROBINSON
Examiner
Art Unit 1627
/MIKHAIL O'DONNEL ROBINSON/Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627