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 .
Claims 1-16 are pending in the instant application. Claim 14 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to non-elected subject matter. The withdrawn subject matter is patentably distinct from the elected subject matter as it differs in structure and element and would require separate search considerations. In addition, a reference which anticipates one group would not render obvious the other. Claims 1-13, 15 and 16 are rejected.
Information Disclosure Statement
The information disclosure statement filed on January 4, 2024 has been considered and a signed copy of form 1449 is enclosed herewith.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-13, 15 and 16, and the compound
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in the response filed on May 6, 2026 is acknowledged. Upon further search and consideration, the election of species requirement has been withdrawn (i.e., the full scope of the subject matter of claims 1-13, 15 and 16 has been searched and examined in its entirety). However, the restriction requirement (between groups) is still deemed proper and is hereby made final.
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 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, 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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 1-13, 15 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 11,292,788.
U.S. Patent No. 11,292,788 discloses compounds of formula (I), which is the same chemical formula as Formula (I) instantly claimed wherein R1 is a group of the structure
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. For example, the compound
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listed in instant claim 4 is specifically disclosed on column 104 of the reference. It is disclosed in the reference that the compounds are suitable for the treatment of autoimmune diseases and chronic inflammation. See abstract and column 3. It is also disclosed in the reference that “the person skilled in the art is aware on the base of his/her expert knowledge of the total daily dosage(s) and administration form(s) of the additional therapeutic agent(s) coadministered…the compounds according to the present invention may be administered in combination therapy…with one or more standard therapeutics, in particular art-known chemotherapeutic or target specific anti-cancer agents.” See column 15, lines 34-48.
It is not disclosed in the reference that the compounds can be used in a method of treating a cancer in a subject in need thereof nor is it disclosed that the compounds enhance the therapeutic effect of an anticancer drug or that they reverse or reduce cancer cell resistance to an anticancer drug and/or sensitizes cancer cells to an anticancer drug.
However, with regards to the compounds enhancing the therapeutic effect of an anticancer drug or that they reverse or reduce cancer cell resistance to an anticancer drug and/or sensitizes cancer cells to an anticancer drug, the claiming of a new use, new function or unknown property, which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
Since the compounds of the reference are used in medicaments for the treatment of diseases or medical conditions and it is disclosed that they can be administered in combination with anti-cancer agents, it would have been obvious to one of ordinary skill in the art at the time of the invention through routine experimentation to use a compound disclosed in U.S. Patent No. 11,292,788 in a method of treating cancer with a reasonable expectation of success. The motivation would have been to find an additional pharmaceutical use for the compounds. Thus, a prima facie case of obviousness has been established.
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 1-13, 15 and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 11,292,788. Although the claims at issue are not identical, they are not patentably distinct from each other for the reasons given below.
U.S. Patent No. 11,292,788 claims compounds of formula (I), which is the same chemical formula as Formula (I) instantly claimed wherein R1 is a group of the structure
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, medicaments thereof and methods of treating diseases or medical conditions. For example, the compound
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listed in instant claim 4 is specifically listed in claim 7 of the reference. It is also disclosed in the reference that “the person skilled in the art is aware on the base of his/her expert knowledge of the total daily dosage(s) and administration form(s) of the additional therapeutic agent(s) coadministered…the compounds according to the present invention may be administered in combination therapy…with one or more standard therapeutics, in particular art-known chemotherapeutic or target specific anti-cancer agents.” See column 15, lines 34-48.
It is not claimed in the reference that the compounds can be used in a method of treating a cancer in a subject in need thereof nor is it disclosed that the compounds enhance the therapeutic effect of an anticancer drug or that they reverse or reduce cancer cell resistance to an anticancer drug and/or sensitizes cancer cells to an anticancer drug.
However, with regards to the compounds enhancing the therapeutic effect of an anticancer drug or that they reverse or reduce cancer cell resistance to an anticancer drug and/or sensitizes cancer cells to an anticancer drug, the claiming of a new use, new function or unknown property, which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
Since the compounds of the reference are used in medicaments for the treatment of diseases or medical conditions and it is disclosed that they can be administered in combination with anti-cancer agents, it would have been obvious to one of ordinary skill in the art at the time of the invention through routine experimentation to use a compound disclosed in U.S. Patent No. 11,292,788 in a method of treating cancer with a reasonable expectation of success. The motivation would have been to find an additional pharmaceutical use for the compounds. Thus, a prima facie case of obviousness has been established.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISTIN ANN VAJDA whose telephone number is (571)270-5232. The examiner can normally be reached Mon-Fri 6:00-4:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James Alstrum-Acevedo can be reached at 571-272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KRISTIN A VAJDA/Primary Examiner, Art Unit 1622
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