DETAILED ACTION
The preliminary amendment submitted on February 8, 2023 has been entered. Claims 104, 124, and 180-183 are pending in the application and are rejected for the reasons set forth below. No claim is allowed.
The present application is being examined under the pre-AIA first-to-invent provi-sions of the Leahy-Smith America Invents Act (AIA ) Public Law 112-29, 125 Stat. 284 (2011).
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.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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.
Claim 104 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Sanchez et al., Levetiracetam suppresses neuronal network dysfunction and reverses synaptic and cognitive deficits in an Alzheimer's disease model. Proc Natl Acad Sci U S A. 2012 Oct 16;109(42):E2895-903. PMID: 22869752 (electronically published Epub 2012 Aug 6.) in view of Laakso et al., Hippocampal volumes in Alzheimer's disease, Parkinson's disease with and without dementia, and in vascular dementia: An MRI study. Neurology. 1996 Mar;46(3):678-81.
Sanchez discloses using levetiracetam in the treatment of cognitive decline in Alzheimer’s disease (abstract). “[T]treatment with LEV also reversed hippocampal remodeling, behavioral abnormalities, synaptic dysfunction, and deficits in learning and memory (abstract). Levetiracetam has an acute injection dose of 200 mg/kg (Sanchez at Table 1), which one would understand to be a ceiling or maximum dosage amount. The dosage amount in the instant claims would be viewed as optimization within the general range taught by this reference. See MPEP 2144.05.
The difference between the prior art and the claims at issue is that Sanchez does not specifically disclose Parkinson’s disease.
Laakso however discloses that hippocampal atrophy is a characteristic of Alzheimer’s, Parkinson’s, and a variety of other disorders of dementia (see abstract).
It would have been prima facie obvious to one of ordinary skill in the art as of the effective filing date to use levetiracetam as taught by Sanchez in the treatment of Parkinson’s and other disorders of cognitive impairment as taught by Laakso and thereby arrive at subject matter within the scope of the instant claims. One would have understood from both references that levetiracetam is useful in mitigating hippocampal dysfunctions, so one would have viewed it is desirable to mitigate this pathology using levetiracetam.
Claims 104 and 124 and 183 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Sanchez and Laakso as applied above to claim 104, and further in view of Murty, US 20110311627 A1
The disclosures of Sanchez and Laakso are relied upon as set forth above. The difference between the prior art and the claims at issue is that neither of these references specifically discloses using an extended-release dosage form.
Murty, however, discloses that extended-release formulations of levetiracetam were known in the prior art. These dosage forms “permit[] greater time periods between dosages, greater patient compliance, and the like” (para. 0002), which would have provided motivation to use them when practicing the treatment method of Samchez/Laakso.
Claims 104,124, 183, and 180 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Sanchez and Laakso and Murty as applied above to claims 104, 124 and 183 above, and further in view of US 20100099735 A1 by Gallagher.
The disclosures of Sanchez, Laakso, and Murty are relied upon as set forth above. The difference between the prior art and the claims at issue is that none of these references specifically discloses using the Clinical Dementia Rating Scale. Gallagher, however, disclose that the Clinical Dementia Rating Scale (para. 0025) was a known clinical technique for assessing the health of dementia patients being treated with levetiracetam (see abstract). It is route and customary in the practice of clinical medicine to use such assays, so one of skill in the art would have viewed the subject matter of instant claim 180 as being prima facie obvious.
Claims 104,124, 183, and 180-181 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Sanchez, Laakso, Murty, and Gallagher as applied above to claims 104,124, 183, and 180 above, and further in view of Curran US 6323177
The disclosures of Sanchez, Laakso, Murty, and Gallagher are relied upon as set forth above. The difference between the prior art and the claims at issue none of these references specifically discloses measuring reelin. Curran, however, discloses that “Reelin, through its interaction with the VLDL receptor, plays an important role both in brain development as well as in the pathogenesis of neurodegenerative diseases, particularly Alzheimer's Disease” (col. 5, ll. 55-70). One would therefore have understood that measuring this biomarker would have been desirable, and therefore prima facie obvious, when treating Alzheimer’s disease.
Claims 104,124, 183, and 180, and 182 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Sanchez, Laakso, Murty, and Gallagher as applied above to claims 104,124, 183, and 180 above, and further in view of WO 2005/047484 A2 by Davies.
The disclosures of Sanchez, Laakso, Murty, and Gallagher are relied upon as set forth above. The difference between the prior art and the claims at issue none of these references specifically discloses measuring somatostatin. Davies, however, discloses (p. 66) that “[a] somatostatin deficit occurs in the cerebral cortex of Alzheimer's disease patients without a major loss in somatostatin10 containing neurons. This deficit could be related to a reduction in the rate of proteolytic processing of peptide precursors. There is a body of evidence to suggest that certain forms of somatostatin in CSF correlate with dementia severity.” One would therefore have understood that measuring this biomarker would have been useful, and therefore prima facie obvious, in monitoring the course of therapy outlined above.
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 appli-cation 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 Good-man, 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 applica-tions 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(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 that 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/eterminaldisclaimer.
Claims 104, 124, and 180-183 are rejected on the ground of nonstatutory double patenting as being unpatentable over Patent No. 10,159,648 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. The ‘648 Patent (cited in the prior action) claims a method of treating cognitive impairment associated with mental retardation, Parkinson's disease, autism, compulsive behavior, or substance addic-tion (claim 15) by administering 220 mg or 190 mg of levetiracetam (claims 1 and 6).
Claims 104, 124, and 180-183 are rejected on the ground of nonstatutory double patenting as being unpatentable over Patent No. 10,925,834 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. The ‘834 Patent claims a method of treating cognitive impairment associated with mental retardation, Park-inson's disease, autism, compulsive behavior, or substance addiction (claim 10) by admin-istering a dosage form of levetiracetam that “provides a steady state plasma concentration of levetiracetam in a subject of between 1.9 μg/ml and 4.4 μg/ml” (claims 1 and 4). Figs. 7-8 of the ‘834 Patent, and the discussion therein, indicate that tablets of 190 mg or 220 mg of levetiracetam result in this steady state plasma concentration, so the examiner concludes that there exists overlap between the dosage amounts claimed in the ‘834 Patent and the dosage amounts of the instant claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Theodore R. Howell whose telephone number is (571)270-5993. The examiner can normally be reached Monday - Thursday, 7:00 am - 6:00 pm (Eastern Time).
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THEODORE R. HOWELL
Primary Examiner
Art Unit 1628
/THEODORE R. HOWELL/Primary Examiner, Art Unit 1628
November 13, 2025 (revised December 8, 2025)