DETAILED ACTION
Claims 33-54 are currently pending in the instant application.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Priority
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Information Disclosure Statement
Applicant's Information Disclosure Statement filed on 06/05/2008 has been considered. Please refer to Applicant's copies of the 1449 submitted herewith.
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 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.
Claims 33-54 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over STOCK (see WIPO Pub NO. 2013/134562, pub. 09/12/2013, which claims priority to U.S. Prov. Appl. No. 61/608,961, filed 03/09/2012 – provided as foreign ref. 101 in IDS dated 6/13/2023).
The applied reference has a common applicant/assignee with the instant application. Based upon the pre-AIA 35 U.S.C. 102(e) date of the reference, it constitutes prior art. This rejection under pre-AIA 35 U.S.C. 103(a) might be overcome by: (1) a showing under 37 CFR 1.132 that any invention disclosed but not claimed in the reference was derived from the inventor of this application and is thus not an invention “by another”; (2) a showing of a date of invention for the claimed subject matter of the application which corresponds to subject matter disclosed but not claimed in the reference, prior to the pre-AIA 35 U.S.C. 102(e) date of the reference under 37 CFR 1.131(a); or (3) an oath or declaration under 37 CFR 1.131(c) stating that the application and reference are currently owned by the same party and that the inventor or joint inventors (i.e., the inventive entity) named in the application is the prior inventor under pre-AIA 35 U.S.C. 104 as in effect on March 15, 2013, together with a terminal disclaimer in accordance with 37 CFR 1.321(c). This rejection might also be overcome by showing that the reference is disqualified under pre-AIA 35 U.S.C. 103(c) as prior art in a rejection under pre-AIA 35 U.S.C. 103(a). See MPEP §§ 2146 et seq.
STOCK teaches compounds of formula
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(see p. 21) and exemplifies many compounds such as
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(see Example 1, p. 58), which corresponds to the 1st compound of claim 33 and the compound of claim 34
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(see Example 2, p. 58), which corresponds to 3rd compound of claim 33 and the compound of claim 36. The compounds are taught to treat cancer (see abstract). The compounds of STOCK differ from those of the instant application in that the substituents on the phenyl ring are in a para rather than meta position (i.e. positional isomers).
According to MPEP 2144.09, Section II, compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). See also In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978) (stereoisomers prima facie obvious).
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Note also In re Deuel 34 USPQ2d 1210, 1214 which states, “Structural relationships may provide the requisite motivation or suggestion to modify known compounds to obtain new compounds. For example, a prior art compound may suggest its homologs because homologs often have similar properties and therefore chemists of ordinary skill would ordinarily contemplate making them to try to obtain compounds with improved properties.”
The instant claims are prima facie obvious because the claims are drawn to positional isomers of the compounds taught by STOCK. A person having ordinary skill in the art would have been motivated to synthesize structurally similar compounds with the expectation that they would have similar properties and utilities. The explicit teaching of STOCK with the enabled examples would have motivated one skilled in the art to synthesize compounds with such generic teaching with the expectation that the synthesized compounds would have similar utility for treatment of cancer.
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.
Rejection I
Claims 33-54 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 11,666,557 (hereafter referred to as ‘557). Although the claims at issue are not identical, they are not patentably distinct from each other because ‘557 is drawn to methods of using compounds of formula
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(see claim 1) with more specific compounds taught such as
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(see claim 14) and species exemplified including
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(see claim 15 of ‘557). This compound corresponds to the first compound of instant claim 33. Further compounds disclosed in claim 15 of ‘557 corresponds to the compounds disclosed in the instant claims – see for example the last compound of instant claim 33 and instant claim 53
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is the 1st compound in col. 93 of ‘557. Regarding claim 54, it would be obvious to add a carrier to an obvious compound – see Ex parte Douros, 163 USPQ 667 (P.T.O. Bd. App. 1968) in order to allow for administration of the compound in the treatment of disease (ie cancer) which ‘557 teaches the compounds are used in methods of treating.
Rejection II
Claims 33-54 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,568,871 (hereafter referred to as ‘871). Although the claims at issue are not identical, they are not patentably distinct from each other because ‘871 is drawn to methods of using compounds of formula
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(see claim 7) with compounds such as
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(see claim 17 of ‘871) exemplified. This compound corresponds to the first compound of instant claim 33. Further compounds disclosed in claim 17 of ‘871 corresponds to the compounds disclosed in the instant claims – see for example the last compound of instant claim 33 and instant claim 53
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is the 4th to last compound of claim 17 of ‘871. Regarding instant claim 54, it would be obvious to add a carrier to an obvious compound – see Ex parte Douros, 163 USPQ 667 (P.T.O. Bd. App. 1968) in order to allow for administration of the compound in the treatment of disease (ie cancer) which ‘871 teaches the compounds are used in methods of treating.
Rejection III
Claims 33-54 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 9,676,754 (hereafter referred to as ‘754). Although the claims at issue are not identical, they are not patentably distinct from each other because ‘754 is drawn to a different scope of compounds that still encompass the compounds of the instant application. US Pat. No. ‘754 teaches compounds of formula
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(see claim 14) and specific compounds in claim 15 along with pharmaceutical compsotisions of said compounds (see claim 16). drawn methods of using compounds of formula
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(see claim 7) with compounds such as 2-(3′-(3-(1-(4-(tert-Butyl)benzyl)-4-ethyl-5-oxo-4,5-dihydro-1H-1,2,4-triazol-3-yl)propyl)-[1,1′-biphenyl]-3-yl)acetic acid which corresponds to
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(see 1st compound of claim 15 of ‘754) exemplified. This compound corresponds to the first compound of instant claim 33. Further compounds disclosed in claim 15 of ‘754 corresponds to the compounds disclosed in the instant claims – see for example the last compound of instant claim 33 and instant claim 53
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is 3′-(3-(1-(4-(tert-Butyl)benzyl)-4-ethyl-5-oxo-4,5-dihydro-1H-1,2,4-triazol-3-yl)propyl)-3-propoxy-[1,1′-biphenyl]-4-yl)acetic acid, which is the 4th to last compound of claim 15 of ‘754. Thus the compounds of the instant claims are taught by ‘754.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAREN CHENG whose telephone number is (703)756-4699. The examiner can normally be reached M-F, 9AM-6PM PST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam Milligan can be reached at 571-270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KAREN CHENG/Primary Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623