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 the Claims
This Office Action is in response to continuation application filed on January 12, 2024. Claim(s) 30-52 are pending and examined herein insofar as they read on the elected invention.
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
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Claims 30, 31, 33-41, and 44-58 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of US 12,144,792. Although the conflicting claims are not identical, they are not patentably distinct from each other. The instant claims are drawn to a method of delaying progression of a neurodegenerative disease or one or more symptoms associated with a neurodegenerative disease in a subject in need thereof comprising: administering a therapeutically effective amount of acetyl-leucine or a pharmaceutically acceptable salt thereof to the subject, wherein the neurodegenerative disease is Parkinson's disease, or one or more symptoms associated with Parkinson's disease. The patented claims are drawn to a method of treating a neurodegenerative disease or one or more symptoms associated with a neurodegenerative disease in a subject in need thereof comprising:
administering a therapeutically effective amount of acetyl-leucine or a pharmaceutically acceptable salt thereof to the subject for a duration of at least 3 months,
wherein the neurodegenerative disease is not cerebellar ataxia or Niemann-Pick Type C, wherein the neurodegenerative disease is chosen from Alzheimer's disease, amyotrophic lateral sclerosis (ALS), multiple system atrophy type P (MSA-P), multiple system atrophy type C (MSA-C), frontotemporal dementia with parkinsonism, progressive supranuclear palsy, corticobasal degeneration, Lewy Body dementia, Parkinson's Disease, and ataxia telangiectasia (Louis Barr disease), and
wherein the therapeutically effective amount of acetyl-leucine or pharmaceutically acceptable salt thereof is administered at least two times a day to achieve a total daily dose of from about 500 mg to about 15 g. The instant claims are embraced by the patented claims and therefore overlap greatly in scope.
Thus, the instant claims are anticipated by the patented claims.
Claims 30-52 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of US 11,998,518. Although the conflicting claims are not identical, they are not patentably distinct from each other. The instant claims are drawn to a method of delaying progression of a neurodegenerative disease or one or more symptoms associated with a neurodegenerative disease in a subject in need thereof comprising: administering a therapeutically effective amount of acetyl-leucine or a pharmaceutically acceptable salt thereof to the subject, wherein the neurodegenerative disease is Parkinson's disease, or one or more symptoms associated with Parkinson's disease. The patented claims are drawn to a method of treating a decrease in cognitive function associated with ageing in a subject in need thereof comprising: (a) identifying the subject having the decrease in cognitive function associated with ageing; (b) taking a baseline measurement of the subject’s cognitive function using one or more tests; (c) administering a therapeutically effective amount of acetyl-leucine or a pharmaceutically acceptable salt thereof to the subject for a treatment duration; (d) measuring the subject’s cognitive function using the one or more tests after the subject is treated; and (e) comparing the subject’s cognitive function after treatment to the baseline measurement to determine if there is an improvement in the subject's cognitive function. The instant claims do not specifically recite steps a-e as claimed in the patented claims as it related to cognition, however the instant claims employ specific assessments and biomarkers to identify the progression of PD and symptoms there. Therefore, the patented claims are embraced by the instant claims.
Thus, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time it was made.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, 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.
Claims 30-34, 39-44, and 49-52 are rejected under 35 U.S.C. 103 as being unpatentable over Schniepp (Cerebellum and Ataxias, 2016) of record in view of Chen (International Journal of Gerontology, 2013).
Schniepp teaches acetyl-DL-leucine was observed to improve ataxic symptoms, including gait, in patients with sporadic and hereditary forms of ataxia.
Schniepp teaches the genetic etiology of patients included 2x ADA, 1 x CACNA-1A mutation, 2x SCA 2, 1x SCA 1 (abstract; page 2, Table 2).
Schniepp teaches patients were treated with acetyl-DL-leucine 5 g/d without titration (500 mg tablets of Tanganil™) for at least 4 weeks. Indication for the treatment with acetyl-DLleucine were the presence of cerebellar symptoms and abnormal findings in the domain “gait” of the Scale and Assessment of Ataxia (SARA) (page 1, Methods).
Schniepp teaches acetyl-DL-leucine may thus offer a new and complementary symptomatic treatment option for cerebellar gait disorders (page 2, Discussion).
Schneipp does not specifically teach gait as a result in a patient population suffering from Parkinson’s Disease.
Chen teaches the presence of gait is one of the cardinal features of Parkinson’s disease (abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have known the success of treatment of acetyl DL leucine in treating gait, as well as envisioned the use of said medicament in treating gait in a patient suffering from PD. The motivation, provided by Chen, teaches gait disorder is one of the cardinal features in PD.
Thus, a treatment useful in treating patients with gait is expected, with a reasonable degree of success, to treat the same ailment that is frequently observed in PD patients.
Regarding claims 32, 42, and 51-52, Schniepp does not teach an enantiomeric excess of the L-enantiomer over the D-enantiomer.
It is well settled patent law that optical isomers would have been expected to possess different therapeutic activities. Most biological systems are sensitive to optical isomerism, motivating the skilled artisan to expect one or another optical isomer to effect greater, or lesser physiological activity. Absent some difference in kind between the various isomers, the skilled artisan would have seen each isomer as prima facie obvious. The skilled artisan would have expected optical isomers to be separable and isomers so separated to exhibit physiological effects at varying levels. Possessing a compound known to contain chiral centers, places all the resultant compounds in the skilled artisan's possession. Thus, use of one or another optical isomer by the skilled artisan would have seen as prima facie obvious, absent some difference in kind between the various isomers (see In re Adamson and Duffin, 125 USPQ 233 (CCPA 1960)).
Thus, based on the foregoing reasons, the instant claims are deemed unpatentable over the cited reference.
Claims 30-36, 37, 38, 40-46, 48, and 51-52 are rejected under 35 U.S.C. 103 as being unpatentable over Saveur (FR 2749512) in view of Yahr (Parkinsonism and Related Disorders, 2003).
Saveur teaches the administration of acetyl DL leucine in treating idiopathic tremor.
Saveur teaches oral administration of acetyl DL leucine at a dose of 2g per day eliminates tremor within 24h.
Saveur does not specifically teach tremor as a result in a patient population suffering from Parkinson’s Disease. Furthermore, Saveur does not teach the limitations of claims 35-38 and 45-48 with respect to biochemical markers and assessments thereof.
Yahr teaches mutually shared polymorphism in the promoter region of the alpha-synuclein gene, found both in patients with essential tremor (ET) (aka idiopathic tremor) or PD which may suggest shared disturbances in regulation of gene expression with apparent potential to induce malfunctions important in the pathogenesis and/or progression of the pathophysiology of both diseases. An in vivo imaging study with DOPASCAN/ SPECT analysis of the dopamine transporter (DAT) as quantitative biomarker for PD onset and severity, designed to differentiate patients with Parkinsonism from controls and patients with ET, found in vivo DAT imaging a reliable marker for dopaminergic degeneration in Parkinsonism. The study also revealed a subgroup of patients with clinical ET and changes in DAT deficiency characteristic of Parkinsonism, suggesting the possibility of an ET/PD overlap syndrome (page 230, 2nd full ¶).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have known the success of treatment of acetyl DL leucine in treating idiopathic tremor as well as envisioned the use of said medicament in treating PD or symptoms thereof, namely tremor. The motivation, provided by Yahr, teaches the overlap in ET and PD, thereby rendering obvious the overlap in the patient population. Thus, a treatment useful in treating patients with ET is expected, with a reasonable degree of success, to treat PD in a patient or tremor associated therewith, due to the overlap in patient population and the commonalities in etiology between said ailments.
Regarding claims 32, 42, and 51-52, Saveur does not teach an enantiomeric excess of the L-enantiomer over the D-enantiomer.
It is well settled patent law that optical isomers would have been expected to possess different therapeutic activities. Most biological systems are sensitive to optical isomerism, motivating the skilled artisan to expect one or another optical isomer to effect greater, or lesser physiological activity. Absent some difference in kind between the various isomers, the skilled artisan would have seen each isomer as prima facie obvious. The skilled artisan would have expected optical isomers to be separable and isomers so separated to exhibit physiological effects at varying levels. Possessing a compound known to contain chiral centers, places all the resultant compounds in the skilled artisan's possession. Thus, use of one or another optical isomer by the skilled artisan would have seen as prima facie obvious, absent some difference in kind between the various isomers (see In re Adamson and Duffin, 125 USPQ 233 (CCPA 1960)).
Thus, based on the foregoing reasons, the instant claims are deemed unpatentable over the cited reference.
Claims 37 and 47 are rejected under 35 U.S.C. 103 as being unpatentable over Saveur (FR 2749512) in view of Yahr (Parkinsonism and Related Disorders, 2003) as applied to claims 30-36, 37, 38, 40-46, 48, and 51-52 as applied to the 103 rejection above in further view of Schrag (The Lancet Neurology, 2016).
Saveur and Yahr are described above.
Neither Saveur and Yahr teach the identification of a biomarker of PD identified by a Montreal Cognitive Assessment (MoCA) score as required by claims 37 and 47.
Schrag teaches clinical markers, imaging markers, and biomarkers for the assessing development of cognitive impairment in Parkinson’s disease (page 69, Table; page 72, Discussion).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to employ acetyl DL leucine in treating tremor in PD patients as discussed in the 103 rejection referenced above, and employed the Montreal Cognitive Assessment (MoCA) to identify a biomarker of PD. The motivation, provided by Schrag, demonstrates the use of this technique with biomarkers as a method of predicting and determining various factors arising for symptoms observed in PD patients. Thus, the skilled artisan would find it obvious to identify a biomarker of PD based on the Montreal Cognitive Assessment (MoCA), wherein acetyl DL leucine is employed in treating idiopathic tremor.
Based on the foregoing reasons, the instant claims are deemed unpatentable over the cited reference.
Conclusion
Claims 30-52 are not allowed.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sahar Javanmard whose telephone number is (571)270-3280. The examiner can normally be reached on Monday-Friday, 9:00-5:00 EST.
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/SAHAR JAVANMARD/Primary Examiner, Art Unit 1622
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