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 .
DETAILED ACTION
This Office Action is in response to Applicant’s Arguments and Amendment filed, 08/28/2025, wherein the Amendment amended claim 1 and cancelled claims 4 and 7.
Claims 1-3, 5-6 and 8-9 are pending and examined on the merits herein..
Priority
This application claims the following priority:
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REJECTIONS WITHDRAWN
The status for each rejection and/or objection in the previous Office Action is set out below.
35 U.S.C. § 102 and 103 over US 2020/0032202 to Bazan
The methods of Bazan require that a cell culture medium composition comprising a ROCK inhibitor, such as fasudil, be cultured for a period of time sufficient for non-neuronal cells to differentiate into neuronal cells, and then administered to the patient with frontotemporal dementia. As such, fasudil is not being administered to a patient as required by the instant claims. As such, this rejection is withdrawn.
35 U.S.C. § 102 over Lingor
Applicant’s argument on pg. 5, Remarks, that Lingor does not disclose treating FTD with fasudil is persuasive to overcome this rejection.
REJECTIONS-MODIFIED
Claim Rejections - 35 USC § 103
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 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 1-2, 6, and 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over US 2015/0031683 to Lingor (published 2015, IDS of 09/23/2022), in view of Gao (Dysregulated molecular pathways in amyotrophic lateral sclerosis-frontotemporal dementia spectrum disorder, The EMBO Jn, published 2017, PTO-892), and Iridoy (Neuroanatomical Quantitative Proteomics Revels Common Pathogenic Biological Routes between Amyotrophic Lateral Sclerosis (ALS) and Frontotemporal Dementia (FTD), International Jn of Molecular Sciences, published 2019, PTO-892).
Lingor teaches a method of treating a subject suffering or prone to suffer from ALS comprising administering a composition comprising fasudil (claims 44, 49, 51), wherein 5% of ALS patients develop frontotemporal dementia (FTD) ([0002]). As such, treating ALS treats the 5% of ALS patients with frontotemporal dementia, i.e., the patient population of ALS patients includes patients with frontotemporal dementia.
Regarding claims 1 and 6, while Lingor teaches a method of treating ALS, wherein 5% also develop FTD, it differs from that of instant claim 1 in that it does not explicitly teach a method of treating frontotemporal dementia.
Gao teaches that FTD overlaps extensively with ALS and that both FTD and ALS can be caused by many mutations in the same set of genes, the most prevalent of these mutations being a GGGGCC repeat expansion in the first intron of C9ORF72 (abstract).
Gao teaches that the notion that ALS and FTD are related and represent two ends of a spectrum disorder is supported by a large body of pathological and genetic evidence (pg. 2931, Col. 2; pg. 2931, Fig 1; pg. 2939, Fig. 4). Gao teaches that, in addition to those already identified, it is certain that many other dysregulated common downstream pathways in the ALS-FTD spectrum disorder will be identified, and that for the sake of therapy development, it is important to determine which pathway or pathways drive disease initiation and how different pathways effect each other during disease progression (pg. 2940, Conclusion).
Iridoy teaches that ALS and FTD are neurodegenerative disorders with an overlap in clinical presentation and neuropathology, sharing clinical features, anatomopathological characteristics, genetic mutations, and pathway alterations leading to neurodegeneration (abstract, pg. 11, Discussion). Iridoy specifically teaches that ALS-TDP-43 and FTLD-U share molecular and functional alteration, confirming involvement of proteins such as ROCK2 (abstract; pg. 4, Table 1; pg. 5, Table 2; pg. 7, Fig. 2). Iridoy additionally teaches that it is widely known that ALS and FTD share a common clinical spectrum, and genetic and pathogenic overlaps (pg. 2, 2nd full paragraph).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to select FTD as a disease additionally treated by Lingor, to arrive at instant claim 1. One of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because:
-Gao and Iridoy teach that FTD and ALS are similar in causation and teach the two diseases as related diseases on a disease spectrum,
-Gao specifically teaches that FTD overlaps extensively with ALS, and that both FTD and ALS can be caused by many mutations in the same set of genes,
-Iridoy specifically teaches that ALS and FTD are neurodegenerative disorders with an overlap in clinical presentation and neuropathology, sharing clinical features, anatomopathological characteristics, genetic mutations, and pathway alterations leading to neurodegeneration,
-Iridoy additionally teaches that Rho-associated protein kinase 2 is involved in both ALS and FTD, wherein Lingor teaches treating ALS with ROCK inhibitor fasudil ([0005]-[0006], [0009], [0104]-[0105], [0132]-[0133], [0142]).
As such, an artisan having ordinary skill would have been motivated to make such a selection, to predictably arrive at a method that is therapeutically effective to treat FTD, in view of FTD’s overlap with ALS.
Regarding claims 2, while the combination of Lingor, Gao, and Iridoy teaches a method of treating FTD by administering fasudil, it differs from that of the instantly claimed invention in that it does not specifically teach administration after the onset of symptoms.
Lingor teaches administration to symptomatic and asymptomatic patients ([0085], [0087]-[0090], [0095], [0108], [0110]. Lingor teaches that male symptomatic groups exhibited higher motoneuron numbers than male asymptotic groups ([0147]).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to select administering the fasudil in the combination of Lingor, Gao, and Iridoy after symptom onset, to arrive at instant claim 2. One of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because:
-Lingor teaches male symptomatic groups, in comparison to symptomatic groups, as exhibiting higher motoneuron numbers following fasudil administration,
-Lingor teaches that fasudil treated ALS mice models, i.e., patients already diagnosed with the disease, demonstrated prolonged survival and disease duration ([0176]), and
-though Lingor teaches that the effect of treatment is more pronounced in ALS patients when fasudil is administered presymtomatically, an artisan having ordinary skill in the art would have been motivated to administer fasudil in patients diagnosed post-symptomatically with FTD because of the expectation of achieving a beneficial effect/slowed progression of the neurodegeneration of the FTD, since not all cases of FTD can be diagnosed presymptomatically.
As such, an ordinary skilled artisan would have been motivated to make such a selection to predictably arrive at a method of prolonging survival in patients with FTD.
Regarding claims 8-9, while the combination of Lingor, Gao, and Iridoy teaches a method of treating FTD by administering fasudil orally (claims 48, 58), it differs from that of claims 8 and 9 in that it does not specifically teach a daily dose of between 70 mg and 140 mg or a daily dose of 90 mg.
Lingor additionally teaches administration of 1-12 mg/kg fasudil (claim 50). In a 60kg patient, this would be a dosage of 60mg-720mg fasudil (see the table in [0061]), and in the case where the claimed ranges “overlap or lie inside ranges disclosed in the prior art” a prima facie case of obviousness exists. See MPEP 2144.05. Moreover, the optimization of known amounts for known active agents is considered well within the competence level of an artisan of ordinary skill in the pharmaceutical sciences; it has been held that the selection of optimal parameters, such as amounts of active agents, to achieve a beneficial effect, is within the skill in the art of an ordinary artisan. See In re Boesch, 205 USPT 215 (CCPA 1980) and MPEP 2144.05.
Claims 3 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over US 2015/0031683 to Lingor (published 2015, IDS of 09/23/2022), Gao (Dysregulated molecular pathways in amyotrophic lateral sclerosis-frontotemporal dementia spectrum disorder, The EMBO Jn, published 2017, PTO-892), and Iridoy (Neuroanatomical Quantitative Proteomics Revels Common Pathogenic Biological Routes between Amyotrophic Lateral Sclerosis (ALS) and Frontotemporal Dementia (FTD), International Jn of Molecular Sciences, published 2019, PTO-892), as applied to claims 1-2, 6, and 8-9, above, and further in view of Johns Hopkins Medicine (“Frontotemporal Dementia,” published 2019, PTO-892 of 05/29/2025).
Lingor, Gao, and Iridoy are applied as discussed above and incorporated herein.
While the combination of Lingor, Gao, and Iridoy teaches a method of treating FTD by administering fasudil, it differs from that of instant claims 3 and 5 in that it does not teach the patient as specifically suffering from behavioral variant frontotemporal dementia or the patient having no neuromuscular symptoms.
Johns Hopkins teaches the most common types of FTD as a) frontal variant, which affects behavior and personality, and b) primary progressive aphasia, which affects the ability to talk and understand language (pg. 1).
Johns Hopkins teaches that a less common form of FTD affects movement (pg. 1).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to specifically select behavioral variants of frontotemporal dementia as the type of FTD treated in the combined method of Lingor, Gao, and Iridoy, to arrive at instant claims 3 and 5. One of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because Johns Hopkins’ teaches the behavior variants as the most common type of FTD and teaches that a less common form of FTD affects movement.
As such an ordinary skilled artisan would have been motivated to select the behavioral variants as the type of FTD treated since this variant encompasses the majority of the patient population diagnosed with FTD.
Response to Arguments
In view of the modified rejection over Lingor, the instant arguments are no longer pertinent.
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 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/apply/applying-online/eterminal-disclaimer.
Claims 1-2, and 8-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 9-12, 20-22 of copending Application No. 19/170,135 ( 04/04/2025 claim set, reference application), as evidenced by The Association for Frontotemporal Degeneration (PTO-892 of 05/29/2025).
Although the claims at issue are not identical, they are not patentably distinct from each other.
‘135 claims a method of treating a patient diagnosed with ALS with fronto-temporal dementia comprising orally administering fasudil (claims 1, 11, 12 and 22).
Regarding claim 2, since ‘135 teaches a method of treating Frontotemporal dementia, the patient has already been diagnosed with the disease. As such, the patient is treated after symptom onset, since symptoms must be present to result in the diagnosis. As evidenced by The Association for Frontotemporal Degeneration, the diagnosis of FTD requires a neurological examination to assess the pattern of cognitive loss (pg. 3, Neuropsychological Testing) and FTD disorders are identified by their clinical symptoms which present as behavior/cognitive changes, or language deficits, or decline in motor function (pg. 5, Clinical Presentations).
Regarding claims 8-9, while ‘135 claims 180mg/day fasudil, an artisan having ordinary skill in the art would have been motivated to modify the effective amount to 70-140 mg, to arrive at one optimized for different patient populations with patients because "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." MPEP 2144.05(II)
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-2, 6, and 8-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 6-7 of copending Application No. 18/712,654 (10/22/2024 claim set, reference application), Gao (Dysregulated molecular pathways in amyotrophic lateral sclerosis-frontotemporal dementia spectrum disorder, The EMBO Jn, published 2017, PTO-892), and Iridoy (Neuroanatomical Quantitative Proteomics Revels Common Pathogenic Biological Routes between Amyotrophic Lateral Sclerosis (ALS) and Frontotemporal Dementia (FTD), International Jn of Molecular Sciences, published 2019, PTO-892).
Although the claims at issue are not identical, they are not patentably distinct from each other.
‘654 claims a method of treating agitation in ALS comprising administering a therapeutically effective amount of fasudil or hydroxyfasudil (claim 1).
Regarding claims 1 and 6, while ‘654 claims a method of treating ALS by administering fasudil and/or hydroxyfasudil, it differs from that if instant claim 1 in that it does not teach treating FTD.
Gao and Iridoy are applied as discussed above and incorporated herein.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to select FTD as a disease additionally treated by ‘654, to arrive at instant claim 1. One of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because:
-Gao and Iridoy teaches that FTD and ALS are similar in causation and teach the two diseases as a related disease on a spectrum,
-Gao specifically teaches that FTD overlaps extensively with ALS, and that both FTD and ALS can be caused by many mutations in the same set of genes,
-Iridoy specifically teaches that ALS and FTD are neurodegenerative disorders with an overlap in clinical presentation and neuropathology, sharing clinical features, anatomopathological characteristics, genetic mutations, and pathway alterations leading to neurodegeneration,
-Iridoy additionally teaches that Rho-associated protein kinase 2 is involved in both ALS and FTD, wherein Lingor teaches treating ALS with ROCK inhibitor fasudil ([0005]-[0006], [0009], [0104]-[0105], [0132]-[0133], [0142]).
As such, an artisan having ordinary skill would have been motivated to make such a selection, to predictably arrive at a method that is therapeutically effective to treat FTD, in view of FTD’s overlap with ALS.
Regarding claim 2, since ‘654 claims a method of treating a patient diagnosed with dementia and ALS, the patient has already been diagnosed with the diseases. As such, since symptoms must be present to result in the diagnosis, the patient is treated after symptom onset. Thus, an ordinary skilled artisan would have been motivated to administer the combined method of ‘654, Gao, and Iridoy after the onset of symptoms to predictably treat FTD.
‘654 claim administration of 90mg fasudil hydrochloride hemihydrate (claims 6-7). While ‘654 does not teach oral administration, an artisan having ordinary skill would have been motivated to administer the compound orally to predictably arrive at a means of providing an mode of administration that is easy to self-administer.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-2, 6, and 8-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 11-13, and 21-22 of copending Application No. 18/665,262 (08/19/2025 claim set, reference application), in view of Gao (Dysregulated molecular pathways in amyotrophic lateral sclerosis-frontotemporal dementia spectrum disorder, The EMBO Jn, published 2017, PTO-892), and Iridoy (Neuroanatomical Quantitative Proteomics Revels Common Pathogenic Biological Routes between Amyotrophic Lateral Sclerosis (ALS) and Frontotemporal Dementia (FTD), International Jn of Molecular Sciences, published 2019, PTO-892).
Although the claims at issue are not identical, they are not patentably distinct from each other.
‘262 claims a method of treating familial ALS comprising orally administering to a patient, a therapeutically effective amount of fasudil or hydroxyfasudil (claim 1).
Regarding claims 1 and 6, while ‘262 claims a method of treating ALS by administering fasudil and/or hydroxyfasudil, it differs from that if instant claim 1 in that it does not teach treating FTD.
Gao and Iridoy are applied as discussed above.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to select FTD as a disease additionally treated by ‘262, to arrive at instant claim 1. One of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because:
-Gao and Iridoy teaches that FTD and ALS are similar in causation and teach the two diseases as a related disease on a spectrum,
-Gao specifically teaches that FTD overlaps extensively with ALS, and that both FTD and ALS can be caused by many mutations in the same set of genes,
-Iridoy specifically teaches that ALS and FTD are neurodegenerative disorders with an overlap in clinical presentation and neuropathology, sharing clinical features, anatomopathological characteristics, genetic mutations, and pathway alterations leading to neurodegeneration,
-Iridoy additionally teaches that Rho-associated protein kinase 2 is involved in both ALS and FTD, wherein Lingor teaches treating ALS with ROCK inhibitor fasudil ([0005]-[0006], [0009], [0104]-[0105], [0132]-[0133], [0142]).
As such, an artisan having ordinary skill would have been motivated to make such a selection, to predictably arrive at a method that is therapeutically effective to treat FTD, in view of FTD’s overlap with ALS.
Regarding claim 2, since ‘262 claims a method of treating a patient diagnosed with ALS, the patient has already been diagnosed with the disease. As such, since symptoms must be present to result in the diagnosis, the patient is treated after symptom onset. Thus, an ordinary skilled artisan would have been motivated to administer the combined method of ‘262, Gao, and Iridoy after the onset of symptoms, to predictably arrive at a method of treating FTD.
‘262 claim administration of 90mg fasudil (claim 13).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-2, and 8-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 10, 12, 14 and 16 of copending Application No. 18/700,424 (04/11/2024 claim set, reference application), as evidenced by The Association for Frontotemporal Degeneration (PTO-892 of 05/29/2025).
Although the claims at issue are not identical, they are not patentably distinct from each other.
‘424 claims a method of treating ALS with frontotemporal dementia comprising administering a therapeutically effective amount of fasudil (claims 1, 16).
Regarding claim 2, since ‘424 claims a method of treating ALS, the patient has already been diagnosed with the disease. As such, the patient is treated after symptom onset, since symptoms must be present to result in the diagnosis. As evidenced by The Association for Frontotemporal Degeneration, the diagnosis of FTD requires a neurological examination to assess the pattern of cognitive loss (pg. 3, Neuropsychological Testing) and FTD disorders are identified by their clinical symptoms which present as behavior/cognitive changes, or language deficits, or decline in motor function (pg. 5, Clinical Presentations).
‘424 claims administration of 60-120 mg/day and 80-240 mg/day fasudil (claims 10, 12); in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05.
‘424 claims oral administration (claim 14).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-2, and 8-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 21, 23, 27-31, and 35-38 of copending Application No. 18/700,614 (04/11/2024 claim set, reference application), as evidenced by The Association for Frontotemporal Degeneration (PTO-892 of 05/29/2025).
Although the claims at issue are not identical, they are not patentably distinct from each other.
‘614 claims a method of treating ALS with frontotemporal dementia comprising orally administering a therapeutically effective amount of a rho kinase inhibitor, such as fasudil (claims 21, 23, 27-30, 35-38).
Regarding claim 2, since ‘614 claims a method of treating ALS, the patient has already been diagnosed with the disease. As such, the patient is treated after symptom onset, since symptoms must be present to result in the diagnosis. As evidenced by The Association for Frontotemporal Degeneration, the diagnosis of FTD requires a neurological examination to assess the pattern of cognitive loss (pg. 3, Neuropsychological Testing) and FTD disorders are identified by their clinical symptoms which present as behavior/cognitive changes, or language deficits, or decline in motor function (pg. 5, Clinical Presentations).
‘614 claims administration of 90 mg fasudil (claim 31).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-2,, 6, and 8-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 11-13 and 17-18 of copending Application No. 18/189,478 (03/24/2023 claim set, reference application), as evidenced by The Association for Frontotemporal Degeneration (PTO-892 of 05/29/2025).
Although the claims at issue are not identical, they are not patentably distinct from each other.
‘478 claims a method of treating wandering in a patient with proteinopathy-associated disease comprising administering a therapeutically effective amount of a rho kinase inhibitor, such as fasudil, wherein the disease is frontotemporal dementia (claims 1, 4, 11-13).
Regarding claim 2, since ‘478 claims a method of treating wandering in a patient with frontotemporal dementia, the patient has already been diagnosed with the disease. As such, the patient is treated after symptom onset, since symptoms must be present to result in the diagnosis. As evidenced by The Association for Frontotemporal Degeneration, the diagnosis of FTD requires a neurological examination to assess the pattern of cognitive loss (pg. 3, Neuropsychological Testing) and FTD disorders are identified by their clinical symptoms which present as behavior/cognitive changes, or language deficits, or decline in motor function (pg. 5, Clinical Presentations).
‘478 claims administration of 70-120 mg/day and greater than 70mg rho kinase inhibitor (claims 17-18); in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05. While ‘478 does not claim oral administration, an artisan having ordinary skill would have been motivated to administer the compound orally to predictably arrive at a means of providing an mode of administration that is easy to self-administer.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-2, 6, and 8-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 6-9, and 11 of copending Application No. 17/760,347 (06/27/2025 claim set, reference application), as evidenced by The Association for Frontotemporal Degeneration (PTO-892 of 05/29/2025).
Although the claims at issue are not identical, they are not patentably distinct from each other.
‘347 claims a method of treating a patient suffering from pseudobulbar affect, wherein the patient is suffering from frontotemporal dementia, comprising orally administering a pharmacologically effective amount of fasudil or hydroxyfasudil in a dose that exceeds 60 mg/day, wherein the disease is frontotemporal dementia (claims 1-3).
‘347 claims 90 mg/day and other amounts (claims 6-9)
Regarding claim 2, since ‘347 claims a method of treating pseudobulbar effect in a patient with frontotemporal dementia, the patient has already been diagnosed with the disease. As such, the patient is treated after symptom onset, since symptoms must be present to result in the diagnosis. As evidenced by The Association for Frontotemporal Degeneration, the diagnosis of FTD requires a neurological examination to assess the pattern of cognitive loss (pg. 3, Neuropsychological Testing) and FTD disorders are identified by their clinical symptoms which present as behavior/cognitive changes, or language deficits, or decline in motor function (pg. 5, Clinical Presentations).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-2, 6, and 8-9 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 19 and 21 of U.S. Patent No. 11,944,633 (PTO-892 of 05/29/2025), as evidenced by The Association for Frontotemporal Degeneration (PTO-892 of 05/29/2025).
Although the claims at issue are not identical, they are not patentably distinct from each other.
‘633 claims an oral pharmaceutical composition comprising fasudil, hydroxyfasudil or both, in an amount sufficient to treat a neurodegenerative disease (claim 1).
‘633 claims about 60-180mg fasudil, hydroxyfasudil or both (claims 2, 19, 21); in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05.
‘633 teaches a method of treating a subject with fronto-temporal dementia by administering the claimed composition of ‘633 (Col. 26, lines 14-32). Regarding claims 2 and 4, since the patient is diagnosed with fronto-temporal dementia, these limitations are met. As evidenced by The Association for Frontotemporal Degeneration, the diagnosis of FTD requires a neurological examination to assess the pattern of cognitive loss (pg. 3, Neuropsychological Testing) and FTD disorders are identified by their clinical symptoms which present as behavior/cognitive changes, or language deficits, or decline in motor function (pg. 5, Clinical Presentations).
Consistent with Sun Pharmaceutical Industries v. Eli Lilly and Col, 611 F. 3d 1381, 1387 (CAFC 2010), it is permissible to use a compound claim to reject a method of use claim where that method of use is disclosed in the specification of the application claiming the compound. According to the Sun Pharma. Court, “[i]t would shock one’s sense of justice if an inventor could receive a patent upon a composition of matter, setting out at length in the specification the useful purposes of such composition, . . .and then prevent the public from making any beneficial use of such product by securing patents upon each of the uses to which it may be adapted. . .”.
Regarding claims 2 and 4, since ‘633 teaches a method of treating frontotemporal dementia, the patient has already been diagnosed with the disease. As such, the patient is treated after symptom onset, since symptoms must be present to result in the diagnosis.
Claims 1-2, and 6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 of U.S. Patent No. 12,128,053 (PTO-892 of 05/29/2025), in view of Gao (Dysregulated molecular pathways in amyotrophic lateral sclerosis-frontotemporal dementia spectrum disorder, The EMBO Jn, published 2017, PTO-892), and Iridoy (Neuroanatomical Quantitative Proteomics Revels Common Pathogenic Biological Routes between Amyotrophic Lateral Sclerosis (ALS) and Frontotemporal Dementia (FTD), International Jn of Molecular Sciences, published 2019, PTO-892).
Although the claims at issue are not identical, they are not patentably distinct from each other.
‘053 claims a method of treating a patient with ALS having dysphagia comprising orally administering a therapeutically effective amount of fasudil and/or hydroxyfasudil (claim 1).
Regarding claims 1 and 6, 2hile ‘053 claims a method of treating ALS by administering fasudil and/or hydroxyfasudil, it differs from that if instant claim 1 in that it does not teach treating FTD.
Gao and Iridoy are applied as discussed above.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to select FTD as a disease additionally treated by ‘053, to arrive at instant claim 1. One of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because:
-Gao and Iridoy teaches that FTD and ALS are similar in causation and teach the two diseases as a related disease on a spectrum,
-Gao specifically teaches that FTD overlaps extensively with ALS, and that both FTD and ALS can be caused by many mutations in the same set of genes,
-Iridoy specifically teaches that ALS and FTD are neurodegenerative disorders with an overlap in clinical presentation and neuropathology, sharing clinical features, anatomopathological characteristics, genetic mutations, and pathway alterations leading to neurodegeneration,
-Iridoy additionally teaches that Rho-associated protein kinase 2 is involved in both ALS and FTD, wherein Lingor teaches treating ALS with ROCK inhibitor fasudil ([0005]-[0006], [0009], [0104]-[0105], [0132]-[0133], [0142]).
As such, an artisan having ordinary skill would have been motivated to make such a selection, to predictably arrive at a method that is therapeutically effective to treat FTD, in view of FTD’s overlap with ALS.
Regarding claim 2, since ‘053 claims a method of treating a patient diagnosed with ALS, the patient has already been diagnosed with the disease. As such, since symptoms must be present to result in the diagnosis, the patient is treated after symptom onset. Thus, an ordinary skilled artisan would have been motivated to administer the combined method of ‘053, Gao, and Iridoy after the onset of symptoms.
Response to Arguments
Regarding the first Double Patenting rejections, Applicant argues that there is no indication that a patent issuing from the instant application would expire after the expiration of a patent issuing from these five copending applications.
This argument has been fully considered, but is not found persuasive. Per MPEP 804(I)(B)(1)(b)(i), the Double Patenting rejection over a copending application is only withdrawn when it is the only remaining rejection and the instant application has the earlier patent term filing date.
On pg. 10, Remarks, Applicant argues regarding Patent Nos. 11,944,633 and 12,128,053 that there is no reason to assume that that a patent issuing on this earlier filed application will extend past the expiration dates of the ‘633 or ‘053 patent.
This argument has been fully considered, but is not found persuasive. Since the rejections over Patent Nos. 11,944,633 and 12,128,053 are not provisional Double Patenting rejections, the effective filing date of the instant application and that of Patent Nos. 11,944,633 and 12,128,053, are not taken into consideration in making the rejection.
Regarding the additional arguments over 11,944,633 and 12,128,053, see the above modified rejections.
Specifically regarding 11,944,633, this patent claims an oral pharmaceutical composition comprising fasudil, hydroxyfasudil or both, in an amount sufficient to treat a neurodegenerative disease (claim 1).
Consistent with Sun Pharmaceutical Industries v. Eli Lilly and Col, 611 F. 3d 1381, 1387 (CAFC 2010), it is permissible to use a compound claim to reject a method of use claim where that method of use is disclosed in the specification of the application claiming the compound. According to the Sun Pharma. Court, “[i]t would shock one’s sense of justice if an inventor could receive a patent upon a composition of matter, setting out at length in the specification the useful purposes of such composition, . . .and then prevent the public from making any beneficial use of such product by securing patents upon each of the uses to which it may be adapted. . .”.
‘633 teaches a method of treating a subject with fronto-temporal dementia by administering the claimed composition of ‘633 (Col. 26, lines 14-32).
As such, Applicant’s arguments are not persuasive to overcome the instant rejections.
Conclusion
No claims are allowed.
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/LAUREN WELLS/Examiner, Art Unit 1622