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 1-5 and 9-10 are pending in the application as of the response filed 03/30/2026. Claims 6-8 are cancelled. Claims 1-5 and 9-10 are examined herein.
Applicant’s remarks regarding the claim for priority benefit to PRO 63/110,922 filed 11/06/2020, was found to be persuasive. Accordingly, the effective filing date of instant claims 1-5 and 9-10 is 11/06/2020.
Applicant’s submission in page 4 of the remarks dated 03/30/2026 that the Aidem and EIP Pharma references were obtained from the inventor and is excepted as prior art under 35 U.S.C. 102(b)(1)(A) (grace period disclosure by inventor or obtained from inventor), was found to be persuasive. The 35 U.S.C. §102 rejections of record over Aidem and EIP Pharma are hereby withdrawn.
The claim amendments do not overcome the U.S.C. §102 rejection of record over Alam. The 35 U.S.C. §102 rejection of record over Alam as evidenced by Morris, is maintained and updated to reflect the claim amendments. The 35 U.S.C. §103 rejection of record over Alam as evidenced by Morris, in view of Giladi is updated to reflect the claim amendments.
A new ground of rejection is made based on a reference cited in the IDS filed on 03/30/2026.
The nonstatutory double patenting rejections of record are maintained and updated to reflect the claim amendments in the instant and co-pending applications.
Applicants’ arguments have been fully considered and are addressed below.
Information Disclosure Statement
The information disclosure statement submitted on 03/30/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 102 – Maintained and updated
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1-2 and 4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Alam (US 2016/00008364 A1, publication date 14 January 2016, in the IDS), as evidenced by Morris et al. (Overview of the Cholinergic Contribution to Gait, Balance and Falls in Parkinson’s Disease, 01 June 2020, hereinafter Morris, of previous record).
Regarding instant claims 1-2 and 4, Alam teaches a method of treating a neurologic disorder by administering an amount of VX-745 (Para. [0031]; Claim 1), having a structure as shown below (Para. [0023]) (Para. [0041] of the instant specification evidences that VX-745 is neflamapimod).
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Alam teaches the neurologic disorder to include Parkinson’s disease (Para. [0032]; Claim 5). Alam teaches the term “treating” to include yielding prophylaxis of ameliorating and/or relieving a disorder, disease, or condition, or one or more symptoms or manifestations of the disorder, disease or condition (Para. [0017]).
Morris evidences the involvement of the cholinergic system for
mobility in Parkinson’s disease (PD) (Abstract; Pg. 9, second full paragraph), specifically involvement of anterior cholinergic (basal forebrain) systems in gait (Abstract; Pg. 6, last paragraph). Morris evidences the cholinergic systems degenerate in PD, with basal forebrain degeneration producing cortical cholinergic denervation (Pg. 2, second full paragraph; Pg. 4, last paragraph). Morris evidences the basal forebrain nuclei contains nucleus basalis of Meynert (nbM) (Pg. 2, second full paragraph; Figure 1), thus showing that the disclosure of Alam meets the instant limitation drawn to “a subject afflicted with forebrain cholinergic neuron degeneration”, “wherein the forebrain cholinergic neuron degeneration comprises degeneration of the nucleus basalis of Meynert (NBM)”.
In view of Morris, it is evident that practicing the method of Alam would have necessarily resulted in treating gait dysfunction or other symptoms thereof, in a subject afflicted with Parkinson’s disease. Therefore, Alam anticipates the limitations of instant claims 1-2 and 4.
Claim Rejections - 35 USC § 103 – Maintained and updated
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.
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Alam (US 2016/00008364 A1, publication date 14 January 2016, in the IDS), as evidenced by Morris et al. (Overview of the Cholinergic Contribution to Gait, Balance and Falls in Parkinson’s Disease, 01 June 2020, hereinafter Morris, of previous record) as applied to claims 1-2 and 4 above, in view of Giladi et al. (Classification of gait disturbances: distinguishing between continuous and episodic changes, 15 September 2014, hereinafter Giladi, of previous record).
The teachings of Alam (as evidenced by Morris) are set forth in the anticipation rejection and incorporated herein by reference.
Regarding instant claims 9-10, the teachings of Alam (as evidenced by Morris) anticipate the method of treating gait dysfunction in a subject afflicted with forebrain cholinergic neuron degeneration, as in instant claim 1.
Alam does not teach wherein the gait dysfunction is continuous or episodic.
Giladi teaches a proposed gait disturbance classification based on continuous versus episodic changes to provide a functional and prognostic framework for gait analysis (Abstract; Pg. 3, second paragraph). Giladi teaches continuous disturbances are chronic and the patient may adapt to them while episodic disturbances are unpredictable and sudden (Pg. 3, second paragraph – third paragraph; Pg. 8, Table 1). Giladi teaches differentiating gait disturbances based on the proposed classification will improve future communication when clinically characterizing a patient’s gait and help inform clinical diagnosis (Pg. 4, first full paragraph - last paragraph).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, in view of the teachings of Alam and Giladi, to have characterized the gait disturbances as continuous or episodic. The motivation being to provide an optimal therapeutic intervention based on the underlying pathology, thereby improving treatment outcomes.
Claims 3 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Alam (US 2016/00008364 A1, publication date 14 January 2016, in the IDS), as evidenced by Morris et al. (Overview of the Cholinergic Contribution to Gait, Balance and Falls in Parkinson’s Disease, 01 June 2020, hereinafter Morris, of previous record) as applied to claims 1-2 and 4 above, in view of Mrak et al. (Common Inflammatory Mechanisms in Lewy Body Disease and Alzheimer Disease, August 2007, hereinafter Mrak, in the IDS dated 03/30/2026).
The teachings of Alam (as evidenced by Morris) are set forth in the anticipation rejection and incorporated herein by reference.
Regarding instant claims 3 and 5, the teachings of Alam (as evidenced by Morris) anticipate the method of treating gait dysfunction in a subject afflicted with forebrain cholinergic neuron degeneration, as in instant claim 1. Alam teaches the neurologic disorder to include Lewy Body Dementia, and Dementias (Para. [0032]; Claim 5).
Alam does not teach wherein the subject has an alpha synuclein disease; wherein the subject has Dementia with Lewy Bodies (DLB) (i.e., a subset of Lewy Body Dementia taught by Alam).
Mrak teaches α-synuclein as a major constituent of Lewy bodies that is implicated in Parkinson disease and dementia with Lewy bodies (i.e., DLB) (Abstract; Pg. 684, second column, second paragraph).
Therefore, the combined teachings of Alam (as evidenced by Morris) in view of Mrak render obvious the method of treating gait dysfunction in a subject, wherein the subject has DLB. Both DLB and Parkinson’s disease taught by Alam as a neurologic condition treated by administering an amount of neflamapimod, have similar underlying pathologies related to alpha synuclein that forms the Lewy bodies. Thus, the teachings of Mrak motivates a PHOSITA to apply the method of Alam in treating gait dysfunction in a subject with DLB, with a reasonable expectation of success. Moreover, the teachings of Mrak evidences that the disclosure of Alam meets the limitation drawn to wherein the subject has an alpha synuclein disease. Therefore, the combined teachings of Alam (as evidenced by Morris) and Mrak render limitations of instant claims 3 and 5 prima facie obvious.
Response to Arguments
Applicants argue on pages 4-6 of the response dated 03/30/2026, that “The Office Action concludes that because Alam teaches treating Parkinson's disease with VX-745, and Morris evidences that PD involves forebrain cholinergic neuron degeneration and gait dysfunction, practicing Alam's method would necessarily result in treating gait dysfunction. Applicant submits that this inherency argument is improper”. Applicants argue “Alam does not teach or suggest treating gait dysfunction that accompanies cholinergic neuron degeneration in the brain. Rather, Alam discloses using VX-745 (neflamapimod) to improve cognition in subjects with various neurodegenerative disorders, which is supported by Alam's experimental results in Morris Water Maze test, which is a cognitive test … The Morris reference likewise does not teach the treatment of gait dysfunction with neflamapimod”. Applicants argue “For inherent anticipation, the result must necessarily flow from the prior art method, not merely be a possibility. Not every drug that treats a disease necessarily treats every symptom of that disease”. Applicants argue “The present specification demonstrates that neflamapimod's efficacy for gait dysfunction was a discovery, supported by clinical data showing statistically significant improvement on TUG tests (p=0.044 for all neflamapimod vs. placebo; p=0.024 for 40 mg TID vs. placebo TID). See the specification at paragraphs [0018]-[0019]. This was not an expected or inevitable result of administering neflamapimod to patients. Accordingly, the rejection of claims 1-2, 4, and 6-8 over Alam should be withdrawn“. Applicants argue on page 6 of the response dated 03/30/2026, that “Giladi merely provides a classification framework for gait disturbances and does not teach or suggest treating any type of gait dysfunction with neflamapimod or any p38 MAPK inhibitor”.
Applicant's arguments have been fully considered but they are not persuasive. The examiner emphasizes that Alam discloses a method of treating a neurologic disorder by administering an amount of neflamapimod, wherein the subject is afflicted with Parkinson’s disease. Morris evidences the involvement of the cholinergic system for mobility in Parkinson’s disease, specifically involvement of anterior cholinergic (i.e., basal forebrain) systems in gait. Thus, Parkinson’s disease is a condition in which the subject is afflicted with forebrain cholinergic neuron degeneration. Instant claim 1 requires the sole active step of administering neflamapimod to a subject afflicted with forebrain cholinergic neuron degeneration. Alam (as evidenced by Morris) teaches the same active step of administering the same therapeutic agent (neflamapimod), to the same patient population (a subject afflicted with forebrain cholinergic neuron degeneration). Therefore, carrying out the method of Alam would necessarily result in the intended therapeutic benefit of treating gait dysfunction.
According to MPEP 2145(II), “Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979) … The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious." Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985)”. In the instant case, even though the method of Alam does not explicitly disclose treating gait dysfunction with the administration of neflamapimod, it naturally follows from carrying out the method of Alam.
Regarding Applicants contention that the Morris reference does not teach the treatment of gait dysfunction with neflamapimod, the examiner notes that the Morris reference is used as an evidentiary reference for the involvement of the cholinergic system related to mobility in Parkinson’s disease and is not used to teach other limitations.
Moreover, Applicants discussion of unexpected TUG results for neflamapimod's efficacy towards gait dysfunction is not applicable to an anticipation rejection. According to MPEP 2131.04 “Evidence of secondary considerations, such as unexpected results or commercial success, is irrelevant to 35 U.S.C. 102 rejections and thus cannot overcome a rejection so based. In re Wiggins, 488 F.2d 538, 543, 179 USPQ 421, 425 (CCPA 1973).”
Applicants argue on page 6 of the response dated 03/30/2026, that “Giladi merely provides a classification framework for gait disturbances and does not teach or suggest treating any type of gait dysfunction with neflamapimod or any p38 MAPK inhibitor”.
Applicant's arguments have been fully considered but they are not persuasive.
Applicants are reminded that the rejection of claims 9-10 is based on an obviousness rationale and not anticipation. No single reference is expected to teach all of the claimed limitations.
According to MPEP 2145 (IV), “One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Where a rejection of a claim is based on two or more references, a reply that is limited to what a subset of the applied references teaches or fails to teach, or that fails to address the combined teaching of the applied references may be considered to be an argument that attacks the reference(s) individually”.
From the above discussion, it is clear that a PHOSITA would have been motivated to characterize the gait disturbances in a subject afflicted with forebrain cholinergic neuron degeneration for optimal therapeutic intervention based on the teachings of Alam and Giladi.
Therefore, for the reasons of record, all rejections are maintained and/or updated.
Double Patenting – Maintained and updated
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-3 and 5 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5-6, 14 and 16-17 of co-pending Application No 17/572,896 as evidenced by Gratwicke et al. (Resting state activity and connectivity of the nucleus basalis of Meynert and globus pallidus in Lewy body dementia and Parkinson’s disease dementia, 22 July 2020, hereinafter Gratwicke).
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to a method of treating a subject afflicted with dementia with Lewy bodies, comprising administering neflamapimod to the subject.
The instant claims are drawn to a method of treating gait dysfunction in a subject afflicted with forebrain cholinergic neuron degeneration, the method comprising administering neflamapimod to the subject.
The claims of co-pending Application No 17/572,896 are drawn to a method of inhibiting loss of choline acetyltransferase (ChAT)-positive neurons in a subject having Dementia with Lewy Bodies, the method comprising treating the subject in need thereof with neflamapimod, wherein said treating comprises
(a) identifying a human having Dementia with Lewy Bodies; and
(b) administering to the human an effective amount of neflamapimod to inhibit loss of ChAT-positive neurons.
The co-pending application does not teach treating gait dysfunction in a subject afflicted with forebrain cholinergic neuron degeneration; wherein the forebrain cholinergic neuron degeneration comprises degeneration of the nucleus basalis of Meynert (NBM); wherein the subject has an alpha synuclein disease by administering neflamapimod to the subject in need thereof.
Gratwicke evidences the presence of cortical Lewy bodies composed of alpha-synuclein as a pathological hallmark of dementia with Lewy bodies (DLB) and association with prominent central nervous system cholinergic dysfunction (Pg. 1, first column, last paragraph). Gratwicke evidences the nucleus basalis of Meynert (NBM) (a nucleus located in the basal forebrain region) implicated in patients with DLB with degeneration of this nucleus shown to be key in the pathogenesis of DLB (Pg. 1, second column, last paragraph - Pg. 2, continued paragraph; Pg. second column, second paragraph). Thus, practicing the method of the co-pending application would have necessarily resulted in treating gait dysfunction in a subject afflicted with forebrain cholinergic neuron degeneration; wherein the forebrain cholinergic neuron degeneration comprises degeneration of the nucleus basalis of Meynert (NBM); wherein the subject has an alpha synuclein disease, since dementia with Lewy bodies is a disease characterized by said features.
Therefore, instant claims 1-3 and 5 and claims 1, 5-6, 14 and 16-17 of co-pending Application No 17/572,896 are not patentably distinct.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-3 and 5 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 9, 13-14 and 18 of co-pending Application No 18/707,318 in view of Alam (US 2016/00008364 A1, publication date 14 January 2016, in the IDS) as evidenced by Gratwicke et al. (Resting state activity and connectivity of the nucleus basalis of Meynert and globus pallidus in Lewy body dementia and Parkinson’s disease dementia, 22 July 2020, hereinafter Gratwicke).
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to a method of treating a subject afflicted with dementia with Lewy bodies, comprising administering a selective p38α mitogen activated protein kinase (MAPK) inhibitor to the subject.
The instant claims are drawn to a method of treating gait dysfunction in a subject afflicted with forebrain cholinergic neuron degeneration, the method comprising administering neflamapimod to the subject.
The claims of co-pending Application No 18/707,318 are drawn to a method for treating a subject having Dementia with Lewy Bodies (DLB) but no substantial tau pathology, the method comprising administering a selective p38α mitogen activated protein kinase (MAPK) inhibitor to the subject.
Claim 13 of the reference co-pending application anticipates a subject afflicted with forebrain cholinergic neuron degeneration and claim 18 of the reference co-pending application anticipates wherein the subject has an alpha synuclein disease.
The co-pending application does not teach treating gait dysfunction in a subject afflicted with forebrain cholinergic neuron degeneration; wherein the forebrain cholinergic neuron degeneration comprises degeneration of the nucleus basalis of Meynert (NBM) and wherein the MAPK inhibitor is neflamapimod.
Alam teaches a method of treating a neurologic disorder by administering an amount of VX-745 (Para. [0031]; Claim 1), having a structure as shown below (Para. [0023]) (Para. [0041] of the instant specification evidences that VX-745 is neflamapimod). Alam teaches the neurologic disorder to include Lewy Body Dementia, and Dementias, Parkinson’s disease (Para. [0032]; Claim 5). Neflamapimod, by virtue of its inherent property is a selective p38α mitogen activated protein kinase (MAPK) inhibitor.
Gratwicke evidences the presence of cortical Lewy bodies composed of alpha-synuclein as a pathological hallmark of dementia with Lewy bodies (DLB) and association with prominent central nervous system cholinergic dysfunction (Pg. 1, first column, last paragraph). Gratwicke evidences the nucleus basalis of Meynert (NBM) (a nucleus located in the basal forebrain region) implicated in patients with DLB with degeneration of this nucleus shown to be key in the pathogenesis of DLB (Pg. 1, second column, last paragraph - Pg. 2, continued paragraph; Pg. second column, second paragraph). Thus, practicing the method of the co-pending application would have necessarily resulted in treating gait dysfunction in a subject afflicted with forebrain cholinergic neuron degeneration; wherein the forebrain cholinergic neuron degeneration comprises degeneration of the nucleus basalis of Meynert (NBM); wherein the subject has an alpha synuclein disease, since dementia with Lewy bodies is a disease characterized by said features.
Therefore, instant claims 1-3 and 5 and claims 1, 9, 13-14 and 18 of co-pending Application No 18/707,318 are not patentably distinct.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-3 and 5 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 9, 11-13 and 17 of co-pending Application No 19/312,779 as evidenced by Gratwicke et al. (Resting state activity and connectivity of the nucleus basalis of Meynert and globus pallidus in Lewy body dementia and Parkinson’s disease dementia, 22 July 2020, hereinafter Gratwicke).
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to a method of treating a subject afflicted with dementia with Lewy bodies, comprising administering neflamapimod to the subject.
The instant claims are drawn to a method of treating gait dysfunction in a subject afflicted with forebrain cholinergic neuron degeneration, the method comprising administering neflamapimod to the subject.
The claims of co-pending Application No 19/312,779 are drawn to a method for treating a subject having Dementia with Lewy Bodies (DLB) but no substantial tau pathology, the method comprising administering neflamapimod to the subject.
Claim 12 of the reference co-pending application anticipates a subject afflicted with forebrain cholinergic neuron degeneration and claim 17 of the reference co-pending application anticipates wherein the subject has an alpha synuclein disease.
The co-pending application does not teach treating gait dysfunction in a subject afflicted with forebrain cholinergic neuron degeneration; wherein the forebrain cholinergic neuron degeneration comprises degeneration of the nucleus basalis of Meynert (NBM).
Gratwicke evidences the presence of cortical Lewy bodies composed of alpha-synuclein as a pathological hallmark of dementia with Lewy bodies (DLB) and association with prominent central nervous system cholinergic dysfunction (Pg. 1, first column, last paragraph). Gratwicke evidences the nucleus basalis of Meynert (NBM) (a nucleus located in the basal forebrain region) implicated in patients with DLB with degeneration of this nucleus shown to be key in the pathogenesis of DLB (Pg. 1, second column, last paragraph - Pg. 2, continued paragraph; Pg. second column, second paragraph). Thus, practicing the method of the co-pending application would have necessarily resulted in treating gait dysfunction in a subject afflicted with forebrain cholinergic neuron degeneration; wherein the forebrain cholinergic neuron degeneration comprises degeneration of the nucleus basalis of Meynert (NBM); wherein the subject has an alpha synuclein disease, since dementia with Lewy bodies is a disease characterized by said features.
Therefore, instant claims 1-3 and 5 and claims 1, 9, 11-13 and 17 of co-pending Application No 19/312,779 are not patentably distinct.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicants argue on pages 6-7 of the response dated 03/30/2026 that “Applicant notes that claims 1 of Application No. 17/572,896 relates to inhibiting loss of cholinergic neurons in a subject having Dementia with Lewy Bodies, which does not anticipate or render obvious treating gait dysfunction. Applicant respectfully requests that the rejection for nonstatutory double patenting be withdrawn”. Applicants argue “Applicant notes that Application No. 18/707,318 and Application No. 19/312,779 have a later patent term filing date than the instant application; thus if nonstatutory double patenting is the only rejection remaining in an application having the earlier patent term filing date, the examiner should withdraw the rejection in the application having the earlier patent term filing date and permit that application to issue as a patent”.
Applicant's arguments have been fully considered but they are not persuasive.
As discussed above, the claims of co-pending ‘896 application as evidenced by Gratwicke renders obvious the method of the instant claims drawn to treating gait dysfunction in a subject afflicted with forebrain cholinergic neuron degeneration by the administration of neflamapimod. Although the reference ‘318 and ‘779 co-pending applications have a later patent term filing date, the provisional nonstatutory double patenting rejections will be maintained until allowable subject matter is identified.
Conclusion
Claims 1-5 and 9-10 are rejected.
No claims are allowed.
Applicant's submission of an information disclosure statement under 37 CFR 1.97(c) with the timing fee set forth in 37 CFR 1.17(p) on 03/30/2026 prompted the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 609.04(b). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PADMAJA S RAO whose telephone number is (571)272-9918. The examiner can normally be reached on 9:00-5:30pm EDT.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney L Klinkel can be reached on (571) 270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PADMAJA S RAO/Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627
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