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 Claims
The amendments to the claims filed April 23, 2026 are acknowledged and entered. Claims 15-44 are pending.
Specification
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any of the errors of which applicant may become aware of in the specification.
Priority
This application is a CON of PCT/US2024/062408, filed December 31, 2024, which claims benefit of 63/617,005, filed January 2, 2024.
Information Disclosure Statement
Acknowledgement is made of the Information Disclosure Statements filed on May 8, 2026 and August 5, 2026. All references have been considered except where marked with a strikethrough.
Election/Restriction
Applicant’s election without traverse of Group III (claims 35-44) and in the reply filed on August 5, 2026 is acknowledged. Claims 15-34 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on August 5, 2026.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 35-44 is/are rejected under 35 U.S.C. 103 as being unpatentable over Washington (WO2009/035673 A1)(hereinafter “Washington”).
Regarding claim 35, Washington teaches a method of retarding formation of a lipofuscin pigment in the retina comprising administering to a patient in need thereof a substituted C20-retinoid
in an amount sufficient to reduce accumulation of a lipofuscin pigment in the retina (claim 1). Washington teaches that method is useful for the treatment of macular degeneration ([0003]) and that Stargardt Disease is the most common form of inherited macular degeneration ([0004]). Washington thus teaches the method is useful for the treatment of Stargardt Disease. Washinton further teaches that the administration of gildeuretinol acetate resulted in a reduction in lipofuscin deposits (Example 5, mice were fed C20-D3-all-trans-retinol acetate; gildeuretinol acetate is also known as C20-D3-all-trans-retinol acetate). Washington teaches that there are currently no therapies available for macular degeneration but that the diagnosis is followed by the progressive loss of central vision for the majority of patients ([0005]).
Regarding claims 36-37, Washington teach a biallelic mutation occurs in Stargardt Disease patients ([0006], mutations in abcr-/ - (responsible for recessive Stargardt disease)).
Regarding claim 38, Washington teaches wherein the mutation is ABCA4 ([0008]).
Regarding claim 39, Washington teaches Stargardt disease patients have retinal flecks ([0006], accumulation of lipofuscin pigments).
Regarding claim 40, Washington teaches vision loss is characterized by loss of central vision ([0004] and [0005]).
Regarding claims 41-42, Washinton teaches that the disease is progressive ([0005]) and that the dose may be administered daily ([0072]).
Regarding claim 43-44, no visible disease progression or vision loss are no more than results of the treatment with gildeuretinol acetate. Administration of gildeuretinol according to the method of Washington would be expected to produce the claimed results.
The difference between the prior art and the instant claims is that the instant claims recite a method of treating a Stargardt disease patient to delay the onset of vision loss in the patient, wherein treatment is initiated prior to the patient experiencing vision loss from the disease, and the claims recite administration for 2 or 4 years. However, it would have been prima facie obvious to one having ordinary skill in the art prior to the effective filing date of the instant application to modify Washington into the claimed invention because Washington had already disclosed that gildeuretinol acetate could be used for the treatment of Stargardt disease and Stargardt disease was known to be associated with progressive vision loss.
One would have been motivated to treat the Stargardt disease before the patient experienced vision loss as a matter of slowing the loss of the patient’s vision and prolonging their ability to see. They would have been motivated to treat the condition for extended periods of time, including those claimed, because the condition was known to be progressive thus suggesting regular and extended administration would be required to continue treating the condition.
One would have had a reasonable expectation of success because there was already a method of treating Stargardt disease comprising administration of gildeuretinol acetate.
Claim(s) 35-44 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arsenijevic (US WO2020011607 A1)(hereinafter “Arsenijevic”) in view of Washington (WO2009/035673 A1)(hereinafter “Washington”).
Arsenijevic teaches a drug treatment for Stargardt disease includes the drug ALK-001 and it is currently tested in clinical trials (page 2, lines 15-20). As evidenced by Chemical Abstract Services, ALK-001 corresponds gildeuretinol acetate. Arsenijevic does not recite a method of treating a Stargardt disease patient to delay the onset of vision loss in the Stargardt disease patient, wherein treatment is initiated prior to the patient experiencing vision loss resulting from the Stargardt disease or the limitations of claims 36-44. However, Washington teaches Stargardt Disease is the most common form of inherited macular degeneration ([0004]). Washington teaches that there are currently no therapies available for macular degeneration but that the diagnosis is followed by the progressive loss of central vision for the majority of patients ([0005]). Washington teaches a biallelic mutation occurs in Stargardt Disease patients ([0006], mutations in abcr-/ - (responsible for recessive Stargardt disease)). Washington teaches wherein the mutation is ABCA4 ([0008]). Washington teaches Stargardt disease patients have retinal flecks ([0006], accumulation of lipofuscin pigments). Washington teaches vision loss is characterized by loss of central vision ([0004] and [0005]).
The difference between the prior art and the instant claims is that the instant claims recite a method of treating a Stargardt disease patient to delay the onset of vision loss in the patient, wherein treatment is initiated prior to the patient experiencing vision loss from the disease, and the claims recite administration for 2 or 4 years wherein no visible disease progression or vision loss occur during the period of administration. However, it would have been prima facie obvious to one having ordinary skill in the art prior to the effective filing date of the instant claims to combine the references into the claimed invention because gildeuretinol acetate was a known drug for the treatment of Stargardt disease and the disease was known to be progressive. Further, no visible disease progression or vision loss are no more than results of the treatment with gildeuretinol acetate. Administration of gildeuretinol acetate would have been expected to produce the claimed results.
One would have been motivated because gildeuretinol acetate was a drug known to treat Stargardt disease. One would have been motivated to treat a Stargardt disease patient before the patient experienced vision loss as a matter of slowing the loss of the patient’s vision and prolonging their ability to see. They would have been motivated to treat the condition for extended periods of time, including those claimed, because the condition was known to be progressive thus suggesting regular and extended administration would be required to continue treating the condition.
One would have had a reasonable expectation of success because gildeuretinol acetate was a drug known to treat Stargardt disease.
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 35-44 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 17-44 of copending Application No. 19/656,441 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the reference claims.
Reference claim 17 recites a method of treating a patient with Stargardt disease, comprising administering to the patient from 14 mg to 24 mg per day of gildeuretinol acetate.
Reference claims 31 recites a method of delaying the progression of vision loss in a patient with Stargardt disease, comprising administering to the patient from 14 mg to 24 mg per day of gildeuretinol acetate.
Reference claims 18-30 and 32-44 recite limitations which overlap the instant claims.
The reference claims recite the limitations of the instant claims and therefore anticipate the claimed invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
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August 28, 2026
/K.S.M./Examiner, Art Unit 1624
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624
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