DETAILED ACTION
Claims 1-3, 5-15, and 17-19 are pending.
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
The instant application, filed 1/12/2023 is a National Stage entry of PCT/US21/12594 , International Filing Date: 1/8/2021. PCT/US21/12594 Claims Priority from Provisional Application 63051532 , filed 7/14/2020.
Information Disclosure Statement
The Information Disclosure Statements (IDS) submitted on 1/12/2023 and 2/6/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the Information Disclosure Statements are being considered by the Examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 6 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Instant claim 6 states, “the method according to claim 1 wherein the treatment results in a greater-than 3-point improvement on the mini mental state exam.” The MPEP 2111.04 states the following in reference to wherein clauses, the court held that when a "‘whereby’ clause states a condition that is material to patentability, it cannot be ignored in order to change the substance of the invention." Id. However, the court noted that a "‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’" Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)).
Given the language doesn’t further limit the claimed method, the claim is rejected. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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, 7-9, 15, and 17-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Qin et al. US 2012/0010196 published 1/12/2012 with evidence from Giráldez-Pérez et al. “Models of α-synuclein aggregation in Parkinson’s disease,” Acta Neuropathologica Communications 2014, 2:176.
Instant claim 1 requires a method of treating a patient with a proteinopathy-associated condition, comprising administering a therapeutically effective amount of a rho kinase inhibitor to said patient, instant claim 2 refines the patient to one with has Huntington's disease or Parkinson's disease.
Qin teaches in claim 1 a method of treating a neurodegenerative disease, comprising administering a formulation to at least one central nervous system component of a mammal, wherein the formulation comprises an inhibitor of Rho-associated protein kinase (ROCK), and wherein the dosage of the ROCK inhibitor is sufficient to inhibit axonal degradation or growth cone collapse of a neuron. Qin’s claim 4 states, method of claim 1, wherein the neurodegenerative disease is Alzheimer's disease, amyotrophic lateral sclerosis, Parkinson's disease, or Niemann-Pick type C disease.
Instant claims 7-9 require the method according to claim 1 wherein the rho kinase inhibitor is an isoquinoline derivative, 8 wherein the isoquinoline derivative is fasudil, a salt, or a derivative thereof. Instant claim 9 requires the method according to claim 7 wherein said derivative is M3.
Qin teaches in claim 3, the method of claim 1, wherein the ROCK inhibitor is Y-27632 (trans-4-[(1R)-1-Aminoethyl]-N-4-pyridinylcyclohexanecarboxamide dihydrochloride), H 1152 ((S)-(+)-2-Methyl-1-[(4-methyl-5-isoquinolinyl)sulfonyl]-hexahydro-1H-1,4-diazepine dihydrochloride), or Fasudil Hydrochloride. Fasudil when administered is a prodrug of M3, as such claim 9 in inherent to the admin of Fasudil.
Instant claim 15 requires the method according to claim 1, wherein said patient has a proteinopathy associated with Parkinson's disease or Down syndrome. PD is taught by Qin.
Instant claim 17 requires wherein the proteinopathy is characterized by deposits containing one or more of the following in normal or mutant form… including deposits comprising α-synuclein (instant claim 18).
Giráldez-Pérez teaches Parkinson's disease patients have aggregation of α-synuclein. Giráldez-Pérez teaches in the Abstract. Parkinson’s disease (PD) is not only characterized by motor disturbances but also, by cognitive, sensory, psychiatric and autonomic dysfunction. It has been proposed that some of these symptoms might be related to the widespread pathology of α-synuclein (α-syn) aggregation in different nuclei of the central and peripheral nervous system.
Giráldez-Pérez teaches (page 2, column 1) these abnormal protein deposits may provoke LB pathologies that involve the deposition of LBs in cell bodies, or the formation of Lewy neurites (LNs) and Papp-Lantos inclusions. While the presence of LBs is a histological hallmark of PD, they are also associated with disorders such as dementia with LBs, multiple system atrophy, Alzheimer’s disease, Down’s syndrome, neurodegeneration with brain iron accumulation type I (Hallervorden-Spatz disease), progressive autonomic failure, rapid eye movement sleep disorder, parkinsonism-dementia complex of Guam, Gaucher’s disease or Pick’s disease. Thereby one instantly envisions the treatment of the progression to multiple system atrophy in these disease state.
Claims 1-2, 7-9, 15, and 17-19 are anticipated by Qin.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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, 3, 5, 7-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Xiao CN 101612157 A published 12/30/2009.
Instant claim 1 requires a method of treating a patient with a proteinopathy-associated condition, comprising administering a therapeutically effective amount of a rho kinase inhibitor to said patient, instant claim 3 refines the patient wherein the patient has dementia.
Xiao teaches in claim 1, the use of fasudil in preparing drugs for inducing neural stem cells of adult brain to regenerate. Then in claims 7 and 8, wherein said nervous system disease is selected from cerebral ischemia, cerebral injury, Alzheimer's disease, Parkinson disease, dementia or retinal disease. Xiao is teaching senile or dementia of old age, as such instant claim 5 to wherein the patient does not have vascular dementia is also anticipated.
Xiao teaches fasudil, or a salt, including Fasudil Hydrochloride. Fasudil when administered is a prodrug of M3, as such claim 9 in inherent to the admin of Fasudil.
Instant claims 1, 3, 5, 7-9 are anticipated.
Claim Rejections - 35 USC § 103
Obviousness of the dependent claims.
In regards to claim 6 to monitoring the patient.
Instant claim 6, the method according to claim 1 wherein the treatment results in a greater-than 3-point improvement on the mini mental state exam.
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 (i.e., changing from AIA to pre-AIA ) 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.
Claims 1-2, 6-9, 15, and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Qin et al. US 2012/0010196 published 1/12/2012, Giráldez-Pérez et al. “Models of α-synuclein aggregation in Parkinson’s disease,” Acta Neuropathologica Communications 2014, 2:176, Tatenhorst et al. “Fasudil attenuates aggregation of α-synuclein in models of Parkinson’s disease,” Acta Neuropathologica Communications (2016) 4:39, and Zadikoff et al. “A Comparison of the Mini Mental State Exam to the Montreal Cognitive Assessment in Identifying Cognitive Deficits in Parkinson’s Disease,” Movement Disorders, Vol. 23, No. 2, 2008.
Instant claim 1 requires a method of treating a patient with a proteinopathy-associated condition, comprising administering a therapeutically effective amount of a rho kinase inhibitor to said patient, instant claim 2 refines the patient to one with has Huntington's disease or Parkinson's disease. The dependent claims indicate Fasudil as a rho kinase inhibitor.
Qin teaches Fasudil for the treatment of Parkinson’s disease, Qin is silent on the disease’s aggregation of α-synuclein.
Giráldez-Pérez teaches that α-synuclein is aggregated in Parkinson’s disease.
Tatenhorst teaches that Fasudil attenuates aggregation of α-synuclein in models of Parkinson’s disease.
Therefore it is taught (not novel) to use Fasudil in Parkinson’s disease, and it is obvious that the drug, Fasudil, would attenuate aggregation of α-synuclein in the disease characterized by aggregation of α-synuclein. These references do not discuss the result of treating the patient with Fasudil on the Mini Mental State Exam (MMSE).
The MPEP 2111.04 states the following in reference to wherein clauses, the court held that when a "‘whereby’ clause states a condition that is material to patentability, it cannot be ignored in order to change the substance of the invention." Id. However, the court noted that a "‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’" Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)).
This clause in instant claim 6 states, “wherein the treatment results in a greater-than 3-point improvement on the mini mental state exam.” This clause is the intended result of a process step positively recited.
Zadikoff is brought in to show that the MMSE is a standard test used in patients with cognitive decline for neuro-decline. Zadikoff states:
Neuropsychological testing is the gold standard for assessing cognition but it is time consuming and many clinicians lack easy and timely access to such assessments. The use of a rapid and easily applied screening test sensitive to cognitive impairment in PD is a more practical approach as it can guide clinical decision making and triage referral to neuropsychological testing. The mini-mental state examination (MMSE) is widely used because it is quick and easy to administer in a clinical setting.
A person of ordinary skill in the art would treat PD patients with Fasudil because it is taught in the art to treat the disease (Qin). A POSA would also predictably expect the drug to attenuate aggregation of α-synuclein because Tatenhorst notes this property of Fasudil in animal models. Lastly a POSA would look to monitor patients by assessing their cognition and would look to use a standard test like the MMSE because the test is rapid and easily applied for screening patients. Claims 1-2, 6-9, 15, and 17-19 are prima facie obvious at the time of filing.
Claim Rejections - 35 USC § 103
Obviousness of the dependent claims.
Instant claims 10-13 to dose and formulation:
Instant claim 10, the method according to claim 1 where said treatment continues for at least 6 months.
Instant claim 11, wherein said isoquinoline derivative is administered in a dose of at least 70 mg per day.
Instant claim 12, wherein said dose is administered in three equal portions throughout the day.
Instant claim 13, the total daily dose is between 70 mg and 180 mg.
Claims 1-2, 7-13, 15, and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Qin et al. US 2012/0010196 published 1/12/2012, Giráldez-Pérez et al. “Models of α-synuclein aggregation in Parkinson’s disease,” Acta Neuropathologica Communications 2014, 2:176, Tatenhorst et al. “Fasudil attenuates aggregation of α-synuclein in models of Parkinson’s disease,” Acta Neuropathologica Communications (2016) 4:39.
Instant claim 1 requires a method of treating a patient with a proteinopathy-associated condition, comprising administering a therapeutically effective amount of a rho kinase inhibitor to said patient, instant claim 2 refines the patient to one with has Huntington's disease or Parkinson's disease. The dependent claims indicate Fasudil as a rho kinase inhibitor.
Qin teaches (anticipates) Fasudil for the treatment of Parkinson’s disease, Qin is silent on the disease’s aggregation of α-synuclein.
Giráldez-Pérez teaches that α-synuclein is aggregated in Parkinson’s disease.
Tatenhorst teaches that Fasudil attenuates aggregation of α-synuclein in models of Parkinson’s disease. Tatenhorst states, “[s]ince Fasudil is already approved for clinical human treatment, the repurposing of this drug for the treatment of PD and other synucleinopathies appears therefore highly promising.”
Therefore it is taught (not novel) to use Fasudil in Parkinson’s disease, and it is obvious that the drug, Fasudil, would attenuate aggregation of α-synuclein in the disease characterized by aggregation of α-synuclein. These references do not discuss the specific dose (70 mg and 180 mg) the duration of treatment (at least 6 months), or a sustained release formulation.
Qin teaches “wherein the dosage of the ROCK inhibitor is sufficient to inhibit axonal degradation or growth cone collapse of a neuron,” claim 1. Qin teaches, “[t]ypically, one of skill in the art also solubilizes test compounds, and decides on their initial dosage ranges according to protocols and knowledge in the art.”
Tatenhorst states, “Treatment with Fasudil, beginning 24 h before transfection, reduced the number of transfected H4 cells with inclusions in a dose-dependent manner within 24 h (Fig. 1a, b).”
Tatenhorst states, “After mice displayed clinical symptoms, long-term Fasudil treatment significantly improved gait performance of α-SynA53T mice as compared to untreated controls. In detail, run average speed was improved dose-dependently as compared to α-SynA53T control, with high Fasudil dosage reaching significance (wt ctrl: 28.6 ± 2.11 cm/s; A53T ctrl: 13.6 ± 1.20 cm/s, p = 7.05x10-6, T-test; A53T Fas10: 19.7 ±1.85 cm/s; A53T Fas30: 21.7 ± 3.24 cm/s, p = 0.03, ANOVA with Dunnett post-hoc test; Fig. 5d). Step sequence regularity index (a fractional measure of interpaw coordination) was significantly improved dose dependently after Fasudil treatment.”
From the MPEP, 2141.02, after KSR, the presence of a known result-effective variable would be one, but not necessarily the only, motivation for a person of ordinary skill in the art to experiment to reach another workable product or process. See MPEP § 2144.05, subsection II.B. See also In re Papesch, 315 F.2d 381, 391, 137 USPQ 43, 51 (CCPA 1963) ("From the standpoint of patent law, a compound and all its properties are inseparable.").
The art is clearly recognizing the dose as result effective in treating aggregation of α-synuclein.
Moreover, Tatenhorst doses Fasudil at 10 mg/kg and 30 mg/kg, giving a POSA a starting point to dose the drug in humans for Parkinson’s disease.
The Supreme Court has clarified that an "obvious to try" line of reasoning may properly support an obviousness rejection. In In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977), the CCPA held that a particular parameter must first be recognized as a result-effective variable, i.e., a variable which achieves a recognized result, before the determination of the optimum or workable ranges of said variable might be characterized as routine experimentation, because "obvious to try" is not a valid rationale for an obviousness finding. However, in KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007), the Supreme Court held that "obvious to try" was a valid rationale for an obviousness finding, for example, when there is a "design need" or "market demand" and there are a "finite number" of solutions. 550 U.S. at 421, 82 USPQ2d at 1397 ("The same constricted analysis led the Court of Appeals to conclude, in error, that a patent claim cannot be proved obvious merely by showing that the combination of elements was ‘[o]bvious to try.’ ... When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under §103."). Thus, after KSR, the presence of a known result-effective variable would be one, but not the only, motivation for a person of ordinary skill in the art to experiment to reach another workable product or process.
As such the claimed doses and duration of dose is obvious as the art teaches the dose as result effective variable for aggregation of α-synuclein. The variable is dose dependent for effect in aggregation. Therefore a POSA would optimize the dose for effect. The art also teaches “long term” treatment and that one would treat as long as improvement was being made. Therefore the duration of at least 6 months is obvious, as duration will be optimized by the doctor.
As such claims 1-2, 7-13, 15, and 17-19 are obvious based on the teaching in the art.
Claim Rejections - 35 USC § 103
Obviousness of the dependent claims.
Instant claim 14 to dose and sustained release formulation:
Instant claim 14, total daily dose exceeds 70 mg and is administered in a sustained release formulation.
Claims 1-2, 7-15, and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Qin et al. US 2012/0010196 published 1/12/2012, Giráldez-Pérez et al. “Models of α-synuclein aggregation in Parkinson’s disease,” Acta Neuropathologica Communications 2014, 2:176, Tatenhorst et al. “Fasudil attenuates aggregation of α-synuclein in models of Parkinson’s disease,” Acta Neuropathologica Communications (2016) 4:39 as applied to claims 1-2, 7-13, 15, and 17-19 above in further view of Kranz WO 2005117896 A1 published 12/15/2005.
Instant claim 14, total daily dose exceeds 70 mg and is administered in a sustained release formulation.
Qin, Giráldez-Pérez, and Tatenhorst render obvious the treatment of PD with Fasudil and optimization of the dose and duration of treatment. These references do not discuss the actual formulation of Fasudil in a “sustained release” formulation.
Kranz teaches solving the problem of needing multiple daily doses of Fasudil by formulatin the drug in a matrix body and an envelope surrounding the matrix body. The matrix body and envelope comprise poly vinyl pyrrolidone and poly vinyl acetate. Release occurs according to zero order reaction kinetics.
A POSA would use the formulation of Kranz because it provides daily dosing instead of multiple doses a day, thereby increasing patient compliance and convenience in patients with PD needing Fasudil as taught by Qin, Giráldez-Pérez, and Tatenhorst.
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 11,666,583
Claims 1, 7-9, and 17-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 11,666,583. Although the claims at issue are not identical, they are not patentably distinct from each other because instant claim 1 teaches fasudil in a patient with Alzheimer's.
‘583 claim 1 states, a method of treating wandering in a patient with Alzheimer's disease, comprising treating the patient with at least 60 mg/day of fasudil, wherein the fasudil is orally administered.
Therefore ‘583 anticipates the claims listed.
US 11,642,352
Claims 1, 3, 5, 7-9, and 17-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 11,642,352. Although the claims at issue are not identical, they are not patentably distinct from each other because instant claim 1 teaches fasudil in a patient with proteinopathy condition including dementia.
‘352 claim 1 states, a method of treating wandering in a patient with dementia with Lewy bodies (DLB), comprising administering a therapeutically effective amount of a fasudil to said patient.
Therefore ‘352 anticipates the claims listed.
US 11,771,704
Claims 1, 7-9, and 17-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 11,771,704. Although the claims at issue are not identical, they are not patentably distinct from each other because instant claim 1 teaches fasudil in a patient with proteinopathy condition including Alzheimer's disease.
‘704 claim 1 states, a method of treating Alzheimer's Disease in patient in need thereof comprising orally administering to a patient suffering from Alzheimer's Disease a pharmacologically effective amount of a fasudil.
Therefore ‘704 anticipates the claims listed.
US 12,329,761
Claims 1, 7-14, and 17-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 12,329,761. Although the claims at issue are not identical, they are not patentably distinct from each other because instant claim 1 teaches fasudil in a patient with proteinopathy condition including Alzheimer's disease.
‘761 claim 1 states, a method of improving cognition in a patient with Alzheimer's Disease comprising orally administering to a patient suffering from Alzheimer's Disease a pharmacologically effective amount of fasudil or a pharmacologically acceptable salt thereof, wherein the fasudil or a pharmacologically acceptable salt thereof is administered in a dose of between 70 and 140 mg per day in an immediate release formulation.
Therefore ‘761 anticipates the claims listed.
US 11,311,553
Claims 1, 7-14, and 17-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11,311,553. Although the claims at issue are not identical, they are not patentably distinct from each other because instant claim 1 teaches fasudil in a patient with proteinopathy condition including progressive supranuclear palsy.
‘553 claim 1 states, a method of treating a patient clinically diagnosed with probable progressive supranuclear palsy or corticobasal syndrome, comprising administering a therapeutically effective amount of fasudil, hydroxyfasudil (M3), or a salt thereof, to said patient.
Therefore ‘553 anticipates the claims listed.
US 11,865,119
Claims 1, 7-14, and 17-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of U.S. Patent No. 11,865,119. Although the claims at issue are not identical, they are not patentably distinct from each other because instant claim 1 teaches fasudil in a patient with proteinopathy condition including Alzheimer's disease dementia.
‘119 claim 1 states, a method of treating agitation in an Alzheimer's disease dementia patient, comprising orally administering to the patient a therapeutically effective amount of fasudil at a dose of 90 mg to 240 mg per day in an immediate release formulation, wherein the patient before treatment has a minimum score on the Cohen-Mansfield Agitation Index (CMAI) of ≥20, and wherein the patient treated with fasudil exhibits an improvement on the CMAI of at least 5 points from the patient's score before treatment with fasudil..
Therefore ‘119 anticipates the claims listed.
Application 18/300,445
Claims 1, 3, 7-9, and 17-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 13 of copending Application No. 18/300,455 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because instant claim 1 states fasudil in a patient with proteinopathy condition including dementia.
‘445 claim 13 states, a method of treating a patient with wandering due to dementia comprising treating said patient with a therapeutically effective amount of fasudil.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Application 17/907,185
Claims 1, 3, 7-9, and 17-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 17/907,185 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because instant claim 1 states fasudil in a patient with proteinopathy condition including dementia.
‘185 claim 1 states, a method of treating frontotemporal dementia comprising administering to a patient suffering from frontotemporal dementia a pharmacologically effective amount of fasudil or a pharmaceutically acceptable salt thereof.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Application 19/206,355
Claims 1, 3, 7-9, and 17-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of copending Application No. 19/206,355 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because instant claim 1 states fasudil in a patient with proteinopathy condition including Alzheimer's disease.
‘355 claim 1 states, a method of improving cognition in a patient with Alzheimer's Disease comprising orally administering to a patient suffering from Alzheimer's Disease a pharmacologically effective amount of fasudil or a pharmacologically acceptable salt thereof, wherein the fasudil or a pharmacologically acceptable salt thereof is administered in a dose of at least 70 mg per day in an immediate release formulation.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Application 18/001,514
Claims 1 and 7-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of copending Application No. 18/001,514 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because instant claim 1 states a rho kinase inhibitor in a patient with proteinopathy condition including dementia.
‘514 claim 1 states, a method of treating vascular dementia, comprising administered to a patient suffering from vascular dementia a therapeutically effective amount of a rho kinase inhibitor.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL J SCHMITT whose telephone number is (571)270-7047. The examiner can normally be reached M-F 8-6 MidDay Flex.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Lundgren can be reached at 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MICHAEL J SCHMITT/Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
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