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 .
DETAILED ACTION
Election of Species and Status of the Claims
Applicant’s election with traverse of
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as the single specific compound in the response filed on December 22nd 2025 is acknowledged. Applicant argues that the compound cited from Whitehead (WO2016/100347A2) in the election of species requirement filed on September 25th 2025 lacks a carbon between the amine and phenyl groups, and thus Whitehead does not serve as art for the instant compounds. However, as demonstrated below, applicant’s compounds are obvious variations of the compounds disclosed by Whitehead. Thus, the election of species requirement is deemed proper. Claims 63-82 are pending and are examined on their merits.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The Information Disclosure Statements filed on February 25th 2025 are in compliance with the provisions of 37 CFR 1.97 and have been considered in full. A signed copy of references cited from the IDS is included with this Office Action.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 78 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more. The claim recites the contact of a biological sample with the compound of claim 63 and an observation of said contact (the modulation of EGFR and/or PI3K). This judicial exception is not integrated into a practical application because only the contact of the sample with the compound and the results of said contact are recited. The claim do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the contact of a biological sample with the compound and the modulation of EGFR and/or PI3K in said sample amounts to a standard laboratory experiment.
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.
Claims 63-82 are rejected under 35 U.S.C. 103 as being unpatentable over Whitehead (WO2016/100347A2 published on June 23rd 2016) in view of Brown (Brown, Bioisosteres in Medicinal Chemistry, 2012).
Claims 63-76 are directed towards applicant’s elected species of:
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.
Whitehead teaches the compound,
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(Whitehead, pg. 11),
which differs from applicant’s compound in just two locations:
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.
One of ordinary skill in the art would have a reasonable expectation of success in developing applicant’s compound from Whitehead’s compound, because both of the aforementioned substitutions (i.e. the replacement of a hydrogen with a chlorine and the replacement of a hydrogen with a methyl) are common bioisosteric replacements, well-known in the art of drug discovery (Brown, pg. 17). Applicant’s compound is thereby an obvious variation of Whitehead’s compound and claims 63-76 are prima facie obvious.
Claim 77 is directed to a pharmaceutical composition comprising the compound of claim 63. Whitehead teaches such pharmaceutical compositions (Whitehead, pg. 25), and claim 77 is prima facie obvious.
Claim 78 is directed towards a method of modulating an EGFR and/or PI3K enzyme in a biological sample via contact of the sample with the compound of claim 63. Whitehead teaches the inhibition of EGFR and PI3K activity in cells via contact of the cells with Whitehead’s compound (Whitehead, pg. 26), and claim 78 is prima facie obvious.
Claims 79-81 are directed towards the treatment of breast cancer with the compound of claim 63. Whitehead teaches the treatment of breast cancers with the compound (Whitehead, pg. 39), and claims 79-81 are prima facie obvious.
Claim 82 limits the breast cancer treated in claim 81 to triple negative breast cancer. Whitehead tests compounds against the MDA-MB-468 triple negative breast cancer cell line. One of ordinary skill in the art would therefore have a reasonable expectation of success in treating triple negative breast cancer with Whitehead’s compounds, and claim 82 is prima facie obvious.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 63-82 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 63-82 of co-pending Application No. 18/307,576 (reference application). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
Nonstatutory 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 63-82 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 11,673,876 (reference patent). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference patent teaches many compounds identical to those found in the instant application. For example, compounds 2, 2R, 2S, 22 and others.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anthony Seitz whose telephone number is (703)756-4657. The examiner can normally be reached 7:30 AM ET - 5:00 PM ET M-F.
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/A.J.S./Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629