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 .
Priority
This application is a continuation-in-part of application No. 18/172,927, filed on Feb. 22, 2023, which is a continuation-in-part of application No. 17/076,069, filed on Oct. 21, 2020, now abandoned, which is a continuation-in-part of application No. 16/789,564, filed on Feb. 13, 2020, now Pat. No. 11,406,625, which is a continuation-in-part of application No. PCT/US2018/046481, filed on Aug. 13, 2018, which claims priority to provisional application No. 62/545315 filed on August 14, 2017.
Information Disclosure Statement
The information disclosure statements (IDSs) filed on March 3, 2024 has been acknowledged and considered.
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 11-27 and 31 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.
Claims 11-27 and 31 recite "The method of claim 1…". However, claim 1 has been cancelled. Thus, there is insufficient antecedent basis for the recitation “The method of claim 1” in claims 11-27 and 31. For the purpose of applying prior art, the claims 11-27 and 31 are interpreted as “The method of claim 10…” as this appears to be applicant’s intent. Applicant may overcome this rejection by correcting claim dependency.
The term “faster” in claims 18-19 and 21 is a relative term which renders the claim indefinite. The term “faster” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Applicant may overcome the rejection by providing a standard for the term “faster”.
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 10-23 and 25 are rejected under 35 U.S.C. 102((a)(1)/(a)(2)) as being anticipated by Squitieri (WO2016138135).
Squiteri teaches a method of treating neurodegenerative disorders such as amyotrophic lateral sclerosis (p. 9, lines 25-26; p. 50, claim 5) by administering pridopidine (p. 20, line 15; p. 13, line 13-21; claim 11). Claims 10-14 are drawn to improvements in specific symptoms of ALS which would necessarily occur upon administration. Furthermore, “treatment” as defined by Squiteri encompasses lessening, removing etc. symptoms of the disorder (p. 12, lines 25-30). Claims 15-17 are drawn to patient outcomes such as decreased risk of death and prolonged survival which would also necessarily occur upon administration. Furthermore, claims 18-21 limit the subject to those with faster disease progression/early ALS which is at once envisaged by the genus of ALS taught by the prior art (MPEP §2131.02(III)). With respect to claims 22-23, administration of pridopidine in Example 1 was daily (p. 27, line 25) and can also be administered orally (p. 11, line 31). With respect to claim 25, the HCl salt is taught (p. 12, line 20). Accordingly, the teachings of Squiteri anticipate claims 10-23 and 25.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 10-26 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Squitieri (WO2016138135) in view of Bassan (US20140378508).
Squiteri teaches a method of treating neurodegenerative disorders such as amyotrophic lateral sclerosis (p. 9, lines 25-26; p. 50, claim 5) by administering pridopidine (p. 20, line 15; p. 13, line 13-21; claim 11) or its HCl salt (p. 12, line 20). Administration of pridopidine in Example 1 was daily (p. 27, line 25) and can also be administered orally (p. 11, line 31). The dose of pridopidine can be further optimized to achieve a therapeutic response without undue adverse events and commensurate with a reasonable benefit/risk ratio (p. 12, line 32 - p. 13, line 12). Pridopidine is taught to be a S1R modulator (p. 13, lines 17-19) and would lessen or remove symptoms of the disorder (p. 12, lines 25-30). Dextromethorphan is taught to be an agonist of the S1R receptor (p. 13, line 31; claim 13) and was tested individually in Example 9 (p. 38, lines 19-32).
Squiteri does not teach administering sequential therapy of pridopidine and dextromethorphan, the dextromethorphan/quinidine combination medication, nor does it teach administering pridopidine to human subjects.
Bassan teaches a method of treating Huntington’s Disease through oral administration of pridopidine or its HCl salt (¶[0015]). In clinical studies 621 patients received doses of pridopidine ranging from 20-90 mg daily (¶[0083]), but may be given once or twice daily (¶[0084]). Results were taken and showed statistically significant changes from baseline in UHDRS-TMS after 26 weeks of pridopidine administration (¶[0732]).
Squiteri and Bassan are analogous art to the claimed invention because they are in the same field of administering pridopidine to a subject possessing a neurological disease or disorder. Therefore, it would have been prima facie obvious to a person having ordinary skill in the art (PHOSITA) before the effective filing date of the claimed invention, to follow the teachings of Squiteri to administer pridopidine to a subject having ALS and further incorporate the teachings of Bassan to administer a dose of pridopidine commensurate to a reasonable benefit/risk ratio. Regarding claim 24, Bassan teaches pridopidine was administered to patients at a dose of 20 to 90 mg daily. This range overlaps with the instantly claimed range and would have been prima facie obvious to a PHOSITA to choose doses within that range with a reasonable expectation of success (MPEP §2144.05(I)). A PHOSITA would be motivated to treat subjects having ALS with pridopidine for 26 weeks through the teachings of Squiteri and Bassan as both HD and ALS are affected by modulation of the S1R pathway. The claimed invention is a combination of prior art elements according to known methods, which to a PHOSITA, would yield predictable results. The improvement of symptoms is considered an inherent property of the administration of pridopidine. Accordingly claims 10-26, and 31 are prima facie obvious.
Claims 10-23 and 25-30 are rejected under 35 U.S.C. 103 as being unpatentable over Squitieri (WO2016138135) in view of Medline (AHFS Patient Medication Information [Internet]. Bethesda (MD): American Society of Health-System Pharmacists, Inc.; c2019. Dextromethorphan and Quinidine; [updated 2016 Nov 15; cited 2026 Mar 25]; [about 5 p.]. Available from: https://medlineplus.gov/druginfo/meds/a611048.html).
The teachings of Squiteri are discussed in paragraph 14 and 15 and incorporated by reference herein and through the same teachings claims 10-23 and 25-26 are prima facie obvious.
Medline teaches the combination of dextromethorphan and quinidine is used to treat pseudobulbar affect in patients with conditions like ALS (first paragraph).
Regarding claims 27-30, Squiteri teaches administration of pridopidine or dextromethorphan individually in subjects having ALS. Medline teaches the combination of dextromethorphan and quinidine is used with people having ALS. With respect to claim 27, it would have been prima facie obvious to a PHOSITA to combine the administration of pridopidine and dextromethorphan/quinidine as they are both known in the art to treat ALS (MPEP 2144.06(I)). With respect to claims 28-30, a skilled artisan would have found it prima facie obvious to co-administer the compositions or to administer them sequentially with one following the other. Accordingly, claims 10-23 and 25-30 are obvious.
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/aply/applying-online/eterminal-disclaimer.
Claims 10-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 11,406,625 (‘625)
Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-15 of ‘625 anticipate instant claims 10-13 and 22-30.
Claims 1-4 of ‘625 recite a method of treating ALS, comprising periodically administering to a subject pridopidine to reduce progression of symptoms like difficulty walking, fasciculations, worsening posture, etc. Instant claims 10-13 are anticipated by claims 1-4 of ‘625 as the scope of the narrower claims in ‘625 are encompassed by the instant claims. The BRI of ALS encompasses any subsets including sporadic ALS and the lessening or improvement of symptoms is inherent with the administration of pridopidine. Claims 5-10 of ‘625 recite administering pridopidine, or its HCl salt, ranging from twice a week to twice daily, including oral administration, where in the dose of pridopidine is 10 mg to 90 mg per day, to a subject that is human.
Claims 11-15 of ‘625 recite administering a second compound with sequential and adjunctive therapy to a subject where either the second compound is administered first, second, or concomitantly with pridopidine. Modification of dosing parameters amounts to routine optimization.
Claims 10-31 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 19/342,730 (‘730). This is a provisional nonstatutory double patenting rejection.
Although the claims at issue are not identical, they are not patentably distinct from each other because instant claims 10-31 encompass claims 1-20 of ‘730.
Claims 1-12 of ‘730 recite a method of treating ALS comprising administering pridopidine and a pridopidine analog of Formula 1 and 4. The composition administered is pridopidine and an analog of the same of Formula 1 and/or 4 and their respective pharmaceutically acceptable salts. Also, recited are lessening of symptoms as a result of administration of the composition as well as administration to certain patient populations. Instant claims 10-21 are anticipated by the copending claims 1-12 of ‘730 because of the open-ended phrase “comprises” in the instant claims which encompasses the administration of an additional compound such as a pridopidine analog of Formula 1 and 4.
Claims 13-20 of ‘730 recite a method of treating ALS with a composition comprising pridopidine and/or an analog of the same with Formula 1 and 4, or their respective salts, wherein the composition(s) is administered ranging from twice a week to at least twice daily, including oral administration, wherein the dose of pridopidine is 10 mg to 90 mg per day, to a subject that is human.
Claims 10-31 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of copending Application No. 19/391,284 (‘284). This is a provisional nonstatutory double patenting rejection.
Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-28 of ‘284 anticipate instant claims 10-31.
Claims 1-19 of ‘284 recite a method of treating ALS comprising administering pridopidine and a lessening of symptoms as a result of administration as well as administration to certain patient populations. Instant claims 10-21 are anticipated by claims 1-19 of ‘284 of administration of pridopidine to subjects with ALS. The BRI of ALS encompasses any subsets including sporadic ALS and the lessening or improvement of symptoms is inherent with the administration of pridopidine.
Claims 20-28 of ‘284 recite administering pridopidine, or its HCl salt, ranging from twice a week to twice daily, including oral administration, wherein the dose of pridopidine is 10 mg to 90 mg per day, to a subject that is human. Also recited, administration of a second compound with sequential and adjunctive therapy to a subject where either the second compound is administered first, second, or concomitantly with pridopidine. Instant claims 22-30 are anticipated by claims 20-28 of ‘284 as the scope of the claims in ‘284 are encompassed by the instant claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAHIL CHANDER AGGARWAL whose telephone number is (571)272-7755. The examiner can normally be reached 7am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam C Milligan can be reached at (571) 270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SAHIL CHANDER AGGARWAL/Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623
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