DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Priority
This application is a divisional application of U.S. Application No. 16/836,832,
filed March 31, 2020, which is a divisional application of U.S. Application No. 16/195,550, filed November 19, 2018, now U.S. Patent No. 10,669,257, which is a divisional application of U.S. Application No. 15/786,334, filed October 17, 2017, now U.S. Patent No. 10,189,814, which is a divisional application of U.S. Application No. 15/040,980, filed February 10, 2016, now U.S. Patent No. 9,822,094, which is a divisional application of U.S. Application No. 13/952,386, filed July 26, 2013, now U.S. Patent No. 9,309,219, which is a divisional application of U.S. Application No. 13/025,105, filed February 10, 2011, now U.S. Patent No. 8,518,972, which
claims priority to U.S. Provisional Application No. 61/303,618, filed February 11, 2010.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 15 June, 2026 has been entered.
Status of the Application
Receipt is acknowledged of Applicant’s claimed invention, filed 15 June, 2026, in the matter of Application N° 17/867,294. Said documents have been entered on the record.
Claims 24-25 are amended. No new matter was introduced.
Thus, Claims 24-25, 27-28, and 30-31 represent all claims currently under consideration.
Response to Amendment/Arguments
Applicant’s arguments filed 15 June, 2026 regarding the requirement to identify a “lead compound” have been fully considered but are not persuasive. As explained in MPEP §2143, the Federal Circuit’s lead-compound cases do not establish that identification of a single lead compound is required in every obviousness rejection of a chemical compound. Rather, the relevant inquiry is whether the prior art would have provided a person of ordinary skill in the art with reason to select and modify the prior-art subject matter, with a reasonable expectation of success.
In any event, Applicant has amended the claims to remove several of the previously disputed alternatives. Accordingly, further discussion of the prior rejection is unnecessary. The amended claims have been reconsidered in view of the amendments and are rejected on the grounds set forth below.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 24-25, 27-28, and 30-31 are rejected under pre-AIA 35 U.S.C. 103(a) as being obvious over Ruchelman (WO 2008/115516 A2, of previous record).
‘516 has a common Assignee and Inventors with the instant application.
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Regarding Claim 24, Ruchelman teaches Formula III, shown top right, wherein Y may be CH2 or C=O, and R5 may be selected from a limited group of aromatic and heteroaromatic substituents including phenyl, naphthyl, furyl, thienyl, benzofuryl, benzothienyl and quinolyl (‘516, Pg. 6-7, Para 31-34), which overlaps the instantly claimed Formula II, shown bottom right, wherein R4 includes quinoline.
Regarding Claim 25, Ruchelman further expressly depicts quinolinyl substituents having both attachment orientations recited by the instantly claimed quinoline species, i.e.,
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(‘516, Pg. 7, Para 35).
Although Ruchelman does not specifically exemplify the presently claimed combination, it would have been prima facie obvious to one of ordinary skill in the art to select the mono-oxo (Y=CH2) variant of Formula III together with quinolyl from the limited group of R5 substituents expressly taught by Ruchelman, thereby arriving at the presently claimed compounds. One of ordinary skill would have been motivated to make such selections because Ruchelman expressly identifies each as a suitable alternative within the disclosed Formula III scaffold and further specifically depicts the relevant quinolinyl substituents in Para 035. One of ordinary skill would have had a reasonable expectation of success because selections merely employ limited structural alternatives expressly taught by Ruchelman for the disclosed compounds, with an expectation that the resulting compounds would retain the utility taught by Ruchelman.
Regarding Claims 27-28, Ruchelman teaches pharmaceutical compositions and dosage forms can further comprise one or more excipients (‘516, Pg. 39, Para 124.) Accordingly, for the reasons set forth above regarding Claims 24-25, the claimed compositions would likewise have been obvious to one of ordinary skill in the art.
Regarding Claims 30-31, Ruchelman teaches a method of treating, managing or preventing a disease or disorder comprising administering to a patient a compound, or a pharmaceutically acceptable salt, solvate, or stereoisomer thereof, wherein the disease or disorder is cancer, a disorder associated with angiogenesis, pain, macular degeneration or a related syndrome, a skin disease, a pulmonary disorder, an asbestos-related disorder, a parasitic disease, an immunodeficiency disorder, a CNS disorder, CNS injury, atherosclerosis or a related disorder, dysfunctional sleep or a related disorder, an infectious disease, hemoglobinopathy or a related disorder, or a TNFα. related disorder. (‘516, Pg. 87, Claim 19.) Accordingly, because Ruchelman teaches both the compounds discussed above and their presently claimed use, the claimed methods would likewise have been obvious to one of ordinary skill in the art.
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.
Claims 24-25, 27-28, and 30-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1, 3-6, 12-14, and 17 of U.S. Patent No. 8,153,659 (of previous record).
Although the claims at issue are not identical, they are not patentably distinct from each other because ‘659 is directed to compounds comprising the same isoindoline/glutarimide core structure as presently claimed and encompass compounds wherein Y is CH2 and the O-linked substituent comprises heteroaryl-containing groups, including bicyclic heteroaryl groups, as found in the patented Claims 1, 3-6 and 12-14. In particular, the patented Claims 12-14 further narrow the compounds to the corresponding O-linked genus wherein the terminal substituent is selected from a limited group of heteroaryl alternatives, including quinolyl and other fused bicyclic heteroaryl groups.
The presently claimed compounds differ from the compounds encompassed by the patented claims principally in the selection of particular fused bicyclic carbocyclic or heterocyclic groups at the corresponding substituent position. Such compounds would have been obvious variants of the compounds claimed in the ‘659 patent because the claimed subject matter merely selects structurally related fused bicyclic ring systems from the limited structural alternatives encompassed by the patented compound genus. Selection of such structurally related ring systems would have represented no more than a predictable structural modification of the patented compounds. One of ordinary skill would have had a reasonable expectation of success because the selections merely employ limited structural alternatives within structurally related ring systems encompassed by the patented claims, with an expectation that the resulting compounds would retain the same utility.
Accordingly, the presently claimed compounds (instant Claims 24-25), are not patentably distinct from the compounds of the ‘659 patented Claims 1, 3-6 and 12-14.
Regarding the presently claimed pharmaceutical compositions (instant Claims 27-28), Claim 17 of the ‘659 patent expressly claims pharmaceutical compositions comprising a compound of Claim 1. Thus, pharmaceutical compositions comprising the presently claimed obvious variants of the patented compounds would likewise have been obvious, since the presently claimed compositions differ only in the use of a compound that is itself not patentably distinct from the compounds of the patented claims.
Regarding the presently claimed methods of treatment (instant Claims 30-31), administration of the presently claimed obvious compound variants for the same therapeutic purposes would likewise have been obvious because the patented compounds and presently claimed compounds are structurally related compounds having the same disclosed utility, and use of the obvious compound variants according to the known therapeutic use would have been reasonably expected to provide the same therapeutic effect.
Communication
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Donna M. Nestor whose telephone number is (703)756-5316. The examiner can normally be reached generally (w/flex): 5:30a-5p EST M-Th.
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/D.M.N./ Examiner, Art Unit 1627
/SARAH PIHONAK/ Primary Examiner, Art Unit 1627
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