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 Claims
Claims 1-22 are pending.
Priority
Instant application 18/630,030, filed 04/23/2024 claims priority as follows:
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Information Disclosure Statement
All references from IDS(s) received 06/16/2024 and 06/14/2026 have been considered unless marked with a strikethrough.
Election/Restrictions
Applicant's election with traverse of the neurodegenerative disease species glaucoma in the reply filed on 06/14/2026 is acknowledged. The traversal is on the ground(s) that “the search is based on the compound not on any one eye disease”. This is not found persuasive because the claims are not merely drawn to compounds but are instead drawn to methods of treatment or prevention of neurodegenerative eye diseases or symptoms thereof in a subject. The specification states that:
A “neurodegenerative eye disease” as used herein is a disease which involves degeneration of neurosensory cells in the eye and/or of the optic nerve, including specifically retinal cells and/or their axons. Neurosensory cells include retinal ganglion cells, optic nerve axon, retinal pigment epithelium cells, cones, rods, and all other neuronal or glial cell types of the retina. Neurodegenerative eye diseases are exemplified by glaucoma, age-related macular degeneration (AMD), including wet and dry AMD, all variants of retinitis pigmentosa, optic neuropathy, including but not limited to ischemic optic neuropathy (ION), hereditary Leber hereditary optic neuropathy (LHON), and retinopathies including for example Stargardt's retinopathy. Neurodegenerative eye diseases are exemplified by diseases of neurons of the eye and their connections, as exemplified by diseases affecting retinal ganglion cells, photoreceptors, other retinal neurons, and corneal nerves.
The term “neurodegenerative eye disease” is therefore a broad term that encompasses various diseases having different etiologies, different affected cells, and different clinical endpoints. For example, glaucoma and age-related macular degeneration (AMD) are both diseases embraced by the term “neurodegenerative eye disease”. While both may cause vision loss, each disease affects the eye differently: AMD attacks the macula (causing central vision loss) while glaucoma damages the optic nerve (causing peripheral vision loss).
Examination of the different disease species would require different fields of search since multiple different search queries and strategies would be required. For example, search of methods comprising administering the claimed compounds to a patient having glaucoma requires a different search technique and queries than searching methods comprising administering to a patient having AMD. Additionally, the Examiner needs to search for and consider applicable prior art for obviousness under 35 U.S.C. 103; this requires broader and more extensive search queries than those searches for anticipatory art. The motivation for administering the compounds to a patient with glaucoma may not necessarily be the same as the motivation administering the compounds to a patient having AMD.
Examination of the different disease species would incur a search and examination burden. The requirement is still deemed proper and is therefore made FINAL.
Applicant stated in the Remarks (06/14/2026) that the elected species reads on claims 1-5, 8, and 18-22.
Therefore, claims 6, 7, and 9-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected disease species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 06/14/2026.
Scope of Search
Examination will begin with the elected species. In accordance with MPEP 803.02, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species, the search of the Markush-type claim will be extended. If prior art is then found that anticipates or renders obvious the non-elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be examined again. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. In the event prior art is found during further examination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final.
The elected species was searched and applicable art was identified. Therefore, the entire scope of the claims has not yet been examined in accordance with Markush search practice. See MPEP 803.02.
Objections to the Specification
The disclosure is objected to because it contains embedded hyperlinks and/or other forms of browser-executable code. See Pages 55-56 of the specification.
Applicant is required to delete the embedded hyperlinks and/or other forms 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.
The disclosure is objected to because of the following informalities: page 43 of the specification contains a typographical error. The structure of Compound 8 is absent.
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.
Claim 18 is 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 18 depends from claim 1 and recites “wherein the composition comprises a unit dose of between 22.5 mg to 315 mg.” The recitation of “a unit dose” without identifying the identity of the compound associated causes claim 18 to be indefinite. It is unclear if the “unit dose” range in claim 18 refers solely to the dose of pridopidine, compound 1, or compound 4; or if the dose refers to any combination of pridopidine, compound 1, and compound 4. References to dosing in the specification appear to refer solely to the amount of pridopidine (Specification, [00126], [00127], [00129], [00146], [00147], [00148]). Therefore, for the purpose of applying prior art, the “unit dose” is being interpreted as associated with the amount of pridopidine.
Appropriate clarification is required.
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.
(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 1-5 and 18-22 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as anticipated by HAYDEN (US 20210220342 A1; cited in IDS; published 22 July 2021).
Claim 1 is drawn to a method of treating, reducing, or inhibiting a neurodegenerative eye disease or symptoms thereof in a subject comprising administering to the subject a composition comprising pridopidine or pharmaceutically acceptable salt thereof and at least one of compounds 1 and 4 or pharmaceutically acceptable salt thereof. Applicant elected glaucoma as the neurodegenerative eye disease species in their Remarks filed 06/14/2026.
Hayden discloses (Hayden, [0139]): a method of treating, suppressing, or inhibiting a disease, disorder, or condition associated with mitochondrial dysfunction in a subject, or any symptom thereof, comprising administering to said subject a composition comprising pridopidine or pharmaceutically acceptable salt thereof, in combination with Compound (1), or Compound (4), a pharmaceutically acceptable salt thereof, or a combination thereof; wherein said disease, disorder, or condition associated with mitochondrial dysfunction comprises:
a) a mood disorder;
b) a mitochondrial myopathy;
c) a lysosomal storage disease;
d) Frontotemporal Dementia (FTD);
e) Charcot-Marie-Tooth Disease (CMT);
or a combination thereof.
Hayden discloses (Hayden, [0086]) that: “said mitochondrial myopathy is selected from MELAS syndrome, MERRF syndrome, Leigh Disease, Alpers Syndrome, Chronic Progressive External Ophthalmoplegia (C/PEO), Diabetes mellitus and deafness (MIDD or DAD, Kearns-Sayre syndrome (KSS), Mitochondrial DNA depletion syndrome (MDS), Mitochondrial neurogastrointestinal encephalomyopathy (MNGIE), Neuropathy, ataxia and retinitis pigmentosa (NARP), Pearson syndrome, Lebers Hereditary Optic Neuropathy (LHON), Dominant Optic Atrophy (DOA), Pigmentary retinopathy, Wolfram Syndrome, Friedrich's Ataxia (FRDA), Mitochondrial neurogastrointestinal encephalomyopathy (MNGIE) and any combinations thereof.”
Hayden anticipates the method claim comprising administering a combination of pridopidine and at least one of compounds 1 and 4 to a subject having “a neurodegenerative eye disease” in view of the above disclosure of at least NARP, LHON, DOA, and pigmentary retinopathy in the above passage.
With respect to the elected species glaucoma, Hayden discloses that the S1R agonist pridopidine exerts neuroprotective effects by activation of the S1R in animal and cellular models of neurodegenerative diseases, including retinal neurodegeneration (Hayden, [0007]). Haden further discloses (Hayden, [0146]): a method of improving mitochondrial function, preventing mitochondrial dysfunction, recovering mitochondrial function, or increasing cell viability in a subject comprising administering to the subject a composition comprising pridopidine or pharmaceutically acceptable salt thereof in combination with Compound (1), or Compound (4), a pharmaceutically acceptable salt thereof, or a combination thereof.
Regarding the elected species, Hayden further discloses (Hayden, [0084]) that in another embodiment, the disease, disorder, or condition associated with mitochondrial dysfunction comprises glaucoma.
Hayden therefore discloses administering the recited pridopidine/analog combination to a subject afflicted with glaucoma, meeting the limitations of claims 1-5 (pridopidine + compound 1; pridopidine + compound 4, pridopidine + compound 1 + compound 4; and glaucoma).
With respect to claim 18, Hayden anticipates (Hayden, [0165]) dosing ranges lying within the range of 22.5 mg to 315 (e.g. 30 mg/day – 40 mg/day).
With respect to claim 19, Hayden anticipates (Hayden, [0162], [0163]) once/twice/three times per day dosing.
With respect to claim 20, Hayden anticipates (Hayden, [0148], [0149]) oral or topical administration.
With respect to claim 21, Hayden anticipates (Hayden, [0148], [0150]) intraocular, intravitreal, periocular, or ocular administration.
With respect to claim 22, Hayden anticipates (Hayden, [0148], [0150]), administration by eye drop application to the conjunctiva.
Therefore claims 1-5 and 18-22 are anticipated.
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.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over HAYDEN (US 20210220342 A1) in view of SCHELLACK et al (SA Pharmaceutical Journal, 2015, 82(5), pp.18-22).
The teachings of Hayden are disclosed above and at least those teachings are incorporated herein by reference.
With respect to claim 8, Hayden discloses glaucoma, but does not specify a particular glaucoma subtype.
However, open-angle glaucoma and angle-closure glaucoma together constitute the two primary categories of glaucoma, and the other recited forms (primary open-angle, pigmentary, pseudoexfoliative, neovascular, steroid-induced, normal-tension, and pressure-independent glaucoma) are species falling within one of those two categories. See SCHELLACK which is relied upon as a secondary reference (Schellack, Table 1):
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Finding of prima facie obviousness
The Supreme Court in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper "functional approach" to the determination of obviousness as laid down in Graham. See MPEP 2143.
Examples of rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
(E) "Obvious to try" – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Applying KSR example rationale (E) and/or (G), it would have therefore been prima facie obvious to administer a combination of pridopidine and at least one of compounds 1 and 4 to a subject having open-angle glaucoma or angle-closure glaucoma upon reading Hayden’s disclosure of “glaucoma” in view of Schellack’s teaching of primary glaucoma subtypes. A person having ordinary skill would have enjoyed a reasonable expectation of success in view of Hayden’s teaching that the combination of pridopidine and at least one of compounds 1 and 4 are useful for treating glaucoma.
Therefore, claim 8 is rejected.
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.
US 11,738,012 B2
Claims 1-5, 8, and 18-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-42 of U.S. Patent No. 11,738,012 in view of HAYDEN (US 20210220342 A1).
The teachings of Hayden are set forth above and at least those teachings are incorporated herein by reference.
The claims of the reference patent only differ from the instant claims by the administration of pridopidine to a subject instead of pridopidine + compound 1 or compound 4 or the combination thereof.
However, as set forth above, Hayden teaches administering pridopidine + compound 1 or compound 4 or the combination thereof to patients having neurodegenerative eye diseases, including glaucoma, NARP, LHON, DOA, and pigmentary retinopathy. Hayden also supplies teachings regarding the dose amount, dose form, and dose schedule as set forth above.
Applying KSR example rationale (A), it would have therefore been prima facie obvious to combine pridopidine in the method of the reference application with compound 1 or compound 4 or the combination thereof as taught by Hayden. The person having ordinary skill would have enjoyed a reasonable expectation of success in view of Hayden’s express teachings to use the combination to treat neurodegenerative eye diseases.
Co-pending 17/513,239
Claims 1-5, 8, and 18-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of copending Application No. 17/513,239 (reference application) in view of HAYDEN (US 20210220342 A1).
The teachings of Hayden are set forth above and at least those teachings are incorporated herein by reference.
The claims of the reference application only differ from the instant claims by the administration of pridopidine to a subject instead of pridopidine + compound 1 or compound 4 or the combination thereof.
However, as set forth above, Hayden teaches administering pridopidine + compound 1 or compound 4 or the combination thereof to patients having neurodegenerative eye diseases, including glaucoma, NARP, LHON, DOA, and pigmentary retinopathy. Hayden also supplies teachings regarding the dose amount, dose form, and dose schedule as set forth above.
Applying KSR example rationale (A), it would have therefore been prima facie obvious to combine pridopidine in the method of the reference application with compound 1 or compound 4 or the combination thereof as taught by Hayden. The person having ordinary skill would have enjoyed a reasonable expectation of success in view of Hayden’s express teachings to use the combination to treat neurodegenerative eye diseases.
This is a provisional nonstatutory double patenting rejection. Please note that a notice of allowance was mailed in the reference application but the application has not yet issued as a patent.
Conclusion
Claims 1-5, 8, and 18-22 are rejected. Claims 6, 7, and 9-17 are withdrawn.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kyle Nottingham whose telephone number is (571)270-0640. The examiner can normally be reached M-F from 10:00 am - 6:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks can be reached at (571) 270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/K.N./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
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