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 .
Claims 1-26 are currently pending. Claim 1 is independent.
Priority Information
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Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. However, the claims contain subject matter that is not present in, and is not supported by, a priority document under 35 U.S.C. 119(e).
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 61/121,379, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for the compounds in claims 1-14 of this application.
Therefore, the instant application cannot receive the benefit of its earlier filing date under 35 U.S.C. 119(e). The effective filing date of the instant application is thus, 10/26/2015.
Response to Election/Restriction
Applicant's election with traverse of Group I, claims 1-14, drawn to a compound of formula (I)
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and a method of treating Parkinson’s disease, Alzheimer’s disease and multiple sclerosis, in the reply filed on November 14, 2025 is acknowledged. Election of the species compound of formula
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, and Alzheimer’s disease, is also acknowledged.
The traversal is on the grounds that since Groups I and II are drawn to nucleoside reverse transcriptase inhibitors (NRTIs), a search and examination of all the groups and species can be made without undue burden. Applicant’s argument has been considered but was found unpersuasive. The inventions require different field of search and employing different search queries because the compounds of Invention I are structurally different, so as to be independent, from the compounds of Invention II. Further, searching for only the subject matter of compounds of claim 4 retrieved 522 compounds in STN. Thus, searching and examining both groups and all compounds encompassed by all the claims will impose a serious burden on the examiner.
The requirement is still deemed proper and is therefore made FINAL.
Claims 15-26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected invention(s), there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on November 14, 2025.
Examination
The elected species of formula
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is not allowable, however, for the purpose of a compact prosecution, examination was expanded to compounds of claim 4
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in which variables R2 and R5 are as in the compounds in the rejections below. Pursuant to M.P.E.P. §803.02, the prior art search will not be extended unnecessarily to cover all non-elected species. The search was not expanded further. Claims 1-3 have not been fully search.
Subject matter outside of the searched/examined scope and claims 15-26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to non-elected inventions there being no allowable generic or linking claim.
Claims 1-14 are the subject of this Office Action.
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Claim Rejections - 35 USC § 102
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.
Claim(s) 1-6, 8 and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Doncel et al. (US 2011/0039798).
The prior art teaches nucleoside derivatives of formula
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and their pharmaceutical compositions for treating viral diseases in a subject. See particularly, Figure 3a, claims 1 and 27-29. The prior art teaches that these are fatty acyl substituted analogues of lamivudine.
Exemplary embodiments of formula III can be found in at least Figure 5:
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,
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and
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. In formula II of claim 4, R5 is an acyl or a substituted alkyl, both of R2 are H, or one R2 is H and the other is an acyl or a substituted alkyl. The instant specification discloses that alkyl groups can optionally be substituted [00148].
Regarding claim 8, wherein one R2 is H and one R2 is C1-C4-alkyl, this is anticipated by compounds 13, 14 and 15 of the reference described above, since -NH-DMTr is the group of formula
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in which a C1-alkyl is substituted by three phenyl groups. The instant specification discloses that alkyl groups can optionally be substituted [00148].
Regarding claim 14, the specification disclosed that treating includes “preventing”. Currently, the only physical step recited in the body of the claim is that of administering the compound to a subject. The compound of the prior art is the same as that of the claims and the patient is the same as that of the claims. The administration of the prior art compound to the prior art subject, would have necessarily resulted in the claimed “prevention” of the conditions recited in claim 14, even if not recognized by the prior art, since products of identical chemical composition cannot have mutually exclusive properties when administered under the same circumstances, and to the same host. See MPEP 2112.
Claim(s) 1-4, 6, 8 and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhang et al. (Tetrahedron 70 (2014), 3826-3831).
The prior art teaches the synthesis of a lamivudine analogue of formula
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. It reads on the claims when R5 is a benzyl group (C1-alkyl which is substituted by a phenyl group) and one R2 is H and the other R2 is acyl or C2-alkyl substituted by an oxo group. The instant specification discloses that alkyl groups can optionally be substituted [00148].
Claim(s) 1-4, 6, 7, 12 and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dang et al. (Mendeleev Commun., 2015, 25, 96-98).
The prior art teaches the synthesis of lamivudine derivatives compound 15
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and compound 16
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. These read on formula II of the claims when R5 is acyl or C4-alkyl is substituted by various groups (comp. 16), and both R2 are acyl or C1-alkyl substituted by an oxo and alkoxy group, or a C3-alkyl chain with an insertion of an oxygen atom and substituted by an oxo. The instant specification discloses that alkyl groups can optionally be substituted and have inserted along the alkyl chain an oxygen atom[00148]. These compounds are to be used in the treatment of HIV. See at least table 1.
Regarding claim 14, the specification disclosed that treating includes “preventing”. Currently, the only physical step recited in the body of the claim is that of administering the compound to a subject. The compound of the prior art is the same as that of the claims and the patient is the same as that of the claims. The administration of the prior art compound to the prior art subject, would necessarily result in the claimed “prevention” of the conditions recited in claim 14, even if not recognized by the prior art, since products of identical chemical composition cannot have mutually exclusive properties when administered under the same circumstances, and to the same host. See MPEP 2112.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 14 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. The prevention (as encompassed in “treating” at paragraph [00114] of the specification) of Alzheimer’s Disease (and of the non-elected diseases) with the claimed compounds is not considered enabled.
As a general rule, enablement must be commensurate with the scope of claim language. MPEP 2164.08 states, “The Federal Circuit has repeatedly held that “the specification must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation.” In re Wright, 999 F.2d 1557, 1561, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)” (emphasis added). The “make and use the full scope of the invention without undue experimentation” language was repeated in 2005 in Warner-Lambert Co. v. Teva Pharmaceuticals USA Inc., 75 USPQ2d 1865, and Scripps Research Institute v. Nemerson, 78 USPQ2d 1019 asserts: “A lack of enablement for the full scope of a claim, however, is a legitimate rejection.” The principle was explicitly affirmed most recently in Liebel-Flarsheim Co. v. Medrad, Inc. 481 F.3d 1371, 82 USPQ2d 1113; Auto. Tech. Int’l, Inc. v. BMW of N. Am., Inc., 501 F.3d 1274, 84 USPQ2d 1108 (Fed. Cir. 2007), Monsanto Co. v. Syngenta Seeds, Inc., 503 F.3d 1352, 84 U.S.P.Q.2d 1705 (Fed. Cir. 2007), and Sitrick v. Dreamworks, LLC, 516 F.3d 993, 85 USPQ2d 1826 (Fed. Cir. 2008).
The following case is of particular relevance to the question of enablement of a method of treating a particular disease:
In In re ′318 Patent Infringement Litigation, 92 USPQ2d 1385 (Fed. Cir. 2009), the claims were drawn to “A method of treating Alzheimer’s disease and related dementias” using a single species (galanthamine). The patented method was invalidated for lack of enablement. The specification had summaries of four scientific papers reporting certain brain effects and positive effects on memory from administering galantamine, but no tie to Alzheimer’s Disease, and applicants presented no reasoning tying those results to Alzheimer’s Disease. The decision notes that “the specification, even read in the light of the knowledge of those skilled in the art, does no more than state a hypothesis and proposes testing to determine the accuracy of that hypothesis.” The District Court also said the specification provided only “minimal disclosure” of utility.
Pursuant to In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988), one considers the following factors to determine whether undue experimentation is required: (A) The breadth of the claims; (B) The nature of the invention; (C) The state of the prior art; (D) The level of one of ordinary skill; (E) The level of predictability in the art; (F) The amount of direction provided by the inventor; (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure. Some experimentation is not fatal; the issue is whether the amount of experimentation is “undue”; see In re Vaeck, 20 USPQ2d 1438, 1444.
The analysis is as follows:
(1) Breadth of claims:
(a) Scope of the compounds. The compounds are of the formula,
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; examined are compounds of claim 4 of formula
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.
(b) Scope of the diseases covered: Prevention and treatment of Alzheimer’s disease.
The ethiology of Alzheimer’s disease is not completely understood (Mangialasche et al., LancetNeurol. 2010; 9: p.702-716).
(2) The nature of the invention and predictability in the art: The invention is directed towards medicine and is therefore physiological in nature. It is well established that “the scope of enablement varies inversely with the degree of unpredictability of the factors involved,” and physiological activity is generally considered to be an unpredictable factor. See In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970).
(3) Direction or Guidance: There is no direction or guidance on how the treatment or prophylaxis of Alzheimer’s disease may be achieved with the claimed compounds. There are no working examples.
(4) State of the Prior Art and working examples: The artisan knows that the toxic protein in Alzheimer's disease is tau and that the disease also involves β-amyloid. The nature of the protein deposits, when these occur, varies as well. In Alzheimer's Disease, there are extracellular plaques from β-amyloid and neurofibrillary tangles (from tau) and there is toxic gain of function with APP and loss of function of Presenilin 1 and presenilin 2. Its etiology involves both tau protein and β-amyloid.
Alzheimer's Disease is an extraordinarily difficult disease to treat, and has been the subject of a vast amount of research, exceeded in recent years only by research into AIDS and cancer. The channel hypothesis of Alzheimer's disease proposes that the beta-amyloid peptides which accumulate in plaques in the brain actually damage and/or kill neurons by forming ion channels. An abnormal phosphorylation of tau proteins is being investigated as one of the important events in the process leading to their aggregation. There appears to be a specific alteration of a p53-mediated intracellular pathway involved in sensing and repairing DNA damage in peripheral cells, and the role of neuronal apoptosis is under investigation. But even as of 2010, there are great unknowns relating to the links between amyloid-ß and tau, to the mechanisms that determine the selective vulnerability of defined neuronal and glial populations, and to the molecular species that cause nerve cell degeneration. Many kinds of therapies have been investigated in the past, including Hydergine-LC (actually approved by the FDA for Alzheimer's Disease, but later determined to make the disease worse), Cu/Zn chelators (or Cu and Zn homeostasis regulators), endothelin B receptor agonists, a-TNF inhibitors, angiotensin II receptor antagonists, ACE inhibitors, EAA agonists (including partial agoinists), estrogens, metabotropic receptor agonists, muscarinic M2 receptor antagonists, free-radical scavengers, butyrylcholinesterase inhibitors, cholinergic agonists, potassium-channel blockers, P38 kinase inhibitors, sigma-1 Receptor Agonists, 5-HT1A receptor antagonists, a secretase stimulants, and others. From this immense body of work, only two kinds of drugs ever emerged. Four Acetylcholinesterase inhibitors were found to have some limited value: tacrine (Cognex®, no longer clinically used); donepezil (Aricept®); galantamine (Razadyne®/Reminyl®/Nivalin®) and rivastigmine (Exelon®). In addition, one voltage-dependent NMDA-antagonist, Memantine (Axura®/Akatinol®/Namenda®/Ebixa®) was also found effective. Categories of agents and techniques under investigation as of 2010 include Aß aggregation inhibitors, assorted antioxidants, γ-Secretase modulators, γ-Secretase inhibitors, β-Secretase inhibitors, NGF mimics, PPAR agonists, HMG-CoA reductase inhibitors (statins), Ampakines, Calcium channel blockers, GABA receptor antagonists, Glycogen synthase kinase inhibitors, Intravenous immunoglobulin, Muscarinic receptor agonists, cholinesterase inhibitors, Nicotinic receptor modulators, Passive Aß immunization, Phosphodiesterase inhibitors, Serotonin receptor antagonists, Active Aß immunization, NGF gene therapy, H3-receptor antagonists, NSAIDs (including NO-NSAIDs and COX-2 Inhibitors), and CB1 and CB2 cannabinoid receptor agonists. It is of course entirely possible that one or more of these will eventually be made to work. However, as can be seen by the many, many categories of drugs which never panned out, simply being the subject of investigation is no indication that enablement is present at that time. The skill level in this art is so low that only Acetylcholinesterase inhibitors and NMDA-antagonists have been made to work. Of course, prevention of such disorders is far beyond current medical science.
An additional complication is that there is no good physiological test for Alzheimer's Disease; one must rely on assorted psychological tests. A definitive diagnosis of Alzheimer's Disease can only be done post mortem.
(5) Skill of those in the art: Those of relative skill in the art are those with level of skill of the authors of the references cited to support the examiner’s position (MD’s PhD's, or those with advanced degrees and the requisite experience in the treatment of Alzheimer’s or Parkinson’s disease).
(6) The quantity of experimentation needed: Owing to the factors listed above, especially in points 3, 4 and 5, the experimentation needed will be extensive.
MPEP 2164.01(a) states, “A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557,1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993).” That conclusion is clearly justified here.
This rejection can be overcome by removing the prophylaxis or prevention at the “treating” term.
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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 8-9 and 14-19 of U.S. Patent No. 11,717,520. Although the claims at issue are not identical, they are not patentably distinct from each other because the instantly claimed compounds are prima facie obvious variants of the compounds in the patented claims.
The instant claims recite, compounds of formula
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, and methods for treating AD, PD and multiple sclerosis with these compounds. These are inhibitors of inflammasome activation by Alu RNA. The claimed compounds are stereoisomers of the compounds in the patented claims.
Determination of the scope and contents of prior art
The patented claims recite compounds of formula
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, and others with similar lamivudine core, wherein the compounds are also inhibitors of inflammasome activation by Alu RNA.
Ascertaining the differences between claims of patent and claims at issue
The difference between the claims in the patent and the instant claims is that the instant claimed compounds are stereoisomers of the compounds in the patented claims.
Finding of prima facie obviousness--rational and motivation (MPEP §2142-2413)
The claimed compounds are stereoisomers of the patented compounds, and thus, have very close structural similarity and the same utility as the patented compounds. One of ordinary skill in the art would have been motivated to use the claimed stereoisomeric compounds in the expectation that compounds similar in structure will have similar properties. It is well known that compounds that are isomeric with compounds of the prior art are unpatentable unless they possess some unobvious or unexpected beneficial property not possessed by the prior art compounds. See In re Schechter and LaForge, 98 USPQ 144, 150. See also In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978) (stereoisomers prima facie obvious); Aventis Pharma Deutschland v. Lupin Ltd., 499 F.3d 1293, 84 USPQ2d 1197 (Fed. Cir. 2007) (5(S) stereoisomer of ramipril obvious over prior art mixture of stereoisomers of ramipril.) This rejection is in accordance with MPEP 2144.09.
Claims 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 12,097,201. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-10 of the patent anticipate the instant claims. The patented claims recite the specific compounds of the rejected claims. See for example compounds of patented claim 1:
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. Regarding the method of treating of claim 14, there is no patentable distinction between the compounds as claimed in the patent, and the method of using the compounds, as in the instant claims. See Ex parte MacAdams, 206 USPQ 445; Pfizer, 518 F.3d at 1363; Geneva, 349 F.3d at 1385-86. The claims of the patent, drawn to the instantly claimed compounds, are not “patentably distinct” from the method of using the compounds instantly claimed.
Claims 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 11,998,547. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-12 of the patent anticipate the instant claim 14 for the method of treating the recited conditions with the same claimed compounds. In addition, the patented claims recite the specific compounds of the rejected claims being used for the treatment of Parkinson’s disease, Alzheimer’s disease and multiple sclerosis. See for example compounds of patented claim 1:
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. Regarding claims 1-13, there is no patentable distinction between the compounds as claimed in the rejected claims 1-13, and the method of using the compounds as in the patented claims. See Ex parte MacAdams, 206 USPQ 445; Pfizer, 518 F.3d at 1363; Geneva, 349 F.3d at 1385-86.
Claims 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3, 5 and 12-15 of U.S. Patent No. 11,219,623. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 3 and 12-15 of the patent anticipate the method of treatment of instant claim 14 for at least the compound of formula
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; and because there is no patentable distinction between the compounds as claimed here, and the method of using the compounds, as in the reference patent. See Ex parte MacAdams, 206 USPQ 445; Pfizer, 518 F.3d at 1363; Geneva, 349 F.3d at 1385-86. Compounds such as of formula
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,
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and those in columns 71 and 72 of the patented claims are stereoisomers of the patented compounds, and thus, have very close structural similarity and the same utility as the patented compounds. One of ordinary skill in the art would have been motivated to make and use the claimed stereoisomeric compounds with the expectation that compounds similar in structure will have similar properties. It is well known that compounds that are isomeric with compounds of the prior art are unpatentable unless they possess some unobvious or unexpected beneficial property not possessed by the prior art compounds. See In re Schechter and LaForge, 98 USPQ 144, 150. See also In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978) (stereoisomers prima facie obvious); Aventis Pharma Deutschland v. Lupin Ltd., 499 F.3d 1293, 84 USPQ2d 1197 (Fed. Cir. 2007) (5(S) stereoisomer of ramipril obvious over prior art mixture of stereoisomers of ramipril.) This rejection is in accordance with MPEP 2144.09.
Claims 1-5 and 11-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 and 11-13 of U.S. Patent No. 10,864,212. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-6 and 11-13 of the patent anticipate the instant claim 14 for the method of treating the recited conditions with the claimed compound of formula
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. Regarding claims 1-5 and 11-13, there is no patentable distinction between the compound as claimed in the rejected claims 1-5 and 11-13, and the method of using the compound as in the patented claims. See Ex parte MacAdams, 206 USPQ 445; Pfizer, 518 F.3d at 1363; Geneva, 349 F.3d at 1385-86. The claims of the patent, drawn to the method of using the compounds, are not “patentably distinct” from the instantly claimed compounds.
Claims 1-5 and 11-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 and 13 of U.S. Patent No. 10,300,057. Although the claims at issue are not identical, they are not patentably distinct from each other because there is no patentable distinction between the compound
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as claimed in the instant claims, and the method of using the compounds, as claimed in the patented claims. See Mosler Sage & Lock Co. V. Mosler, Bahmann & Co., 127 U.S. 354, 218 S.Ct. 1148 (1888) [The first patent was of an article; the second patent, held invalid, was for a method of making it]. See also Ex parte MacAdams, 206 USPQ 445 [The patent had a composition of matter; the application had the method of use]. The claims of the patent disclose the compound and its utility and the instant claims claim the same compound.
This rejection is also proper under the recent court decision in Sun Pharmaceutical Industries Ltd. v. Eli Lilly and Co., 95 USPQ 2d 1797. The claims of a later patent were invalid for obviousness-type double patenting because the earlier patent claimed the compound and disclosed its utility in the specification, and the later patent claimed a method of using the patented compound for the use described in the specification of the earlier patent.
Claims 1-5 and 11-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 and 11-20 of U.S. Patent No. 11,602,535. Although the claims at issue are not identical, they are not patentably distinct from each other because there is no patentable distinction between the compound
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as claimed in the instant claims, and the method of using the compound, as claimed in the patented claims. See Mosler Sage & Lock Co. V. Mosler, Bahmann & Co., 127 U.S. 354, 218 S.Ct. 1148 (1888) [The first patent was of an article; the second patent, held invalid, was for a method of making it]. See also Ex parte MacAdams, 206 USPQ 445 [The patent had a composition of matter; the application had the method of use]. The claims of the patent disclose the compound and its utility and the instant claims claim the same compound.
This rejection is also proper under the recent court decision in Sun Pharmaceutical Industries Ltd. v. Eli Lilly and Co., 95 USPQ 2d 1797. The claims of a later patent were invalid for obviousness-type double patenting because the earlier patent claimed the compound and disclosed its utility in the specification, and the later patent claimed a method of using the patented compound for the use described in the specification of the earlier patent.
Claims 1-5 and 11-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 13 and 13 of U.S. Patent No. 9,326,983. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 12 and 13 of the patent anticipate instant claims 1-5 and 11-13 for compound of formula
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.
Conclusion
Claims 1-14 are rejected. No claim is in condition for allowance.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VALERIE RODRIGUEZ-GARCIA whose telephone number is (571)270-5865. The examiner can normally be reached Monday-Friday 9:30am-5:30pm.
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/VALERIE RODRIGUEZ-GARCIA/Primary Examiner, Art Unit 1621 01/23/2026