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 32, 33, 35, and 37-41, submitted on 31 July 2026, represent all claims currently under consideration.
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.
Information Disclosure Statement
One Information Disclosure Statement (IDS), submitted on 5 May 2026, is acknowledged and has been considered.
Response to Arguments
The 35 U.S.C. § 103 rejection of Claims 32, 33, 35, and 37-41 over U.S. Patent No. 11,186,875 in view of WO 2019/051155, WO 2008/1501181, and Jones is withdrawn. Applicant argues that Carpten broadly discloses the treatment of cholangiocarcinoma associated with an RBPMS-NRG1 fusion by administering an ERBB2 inhibitor selected from numerous possible agents, including trastuzumab and pertuzumab, and an EGFR inhibitor selected from numerous agents including afatinib. Applicant further argues that Carpten does not direct the artisan to the claimed combination, and it does not identify any benefit from co-administration. Applicant further argues that Carpten’s only actual treatment example uses antibody therapy alone, namely, trastuzumab in combination with pertuzumab. The Examiner finds these arguments, along with the previous arguments related to the unexpected synergy of a combined TKI and anti-HER2/HER3 antibody treatment to be persuasive, and the rejection is withdrawn.
The provisional non-statutory double patenting rejection of Claims 32, 33, 35, and 37-41 over co-pending application U.S. 17/759,713 is maintained as Applicant has not provided arguments as to why the rejection should be withdrawn, and the co-pending application has the same effective filing date as the examined application.
Double Patenting- REJECTIONS MAINTAINED
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 32, 33, 35, and 37-41 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 5, and 7-9 of copending Application No. 17/759,713 (Amended Claims of 18 December 2025) (‘713) (reference application) in view of Lee (WO 2008/150118A1; Publication Date: 11 December 2008) and Jones (Annals of Oncology, 28: 3092-3097, 2017).
Determining the Scope and Contents of the Prior Art:
Claim 1 of ‘713 claims the use of poziotinib in the treatment of a patient having a cancer having an NRG1 fusion, the method comprising administering to the patient a therapeutically effective amount of poziotinib and a HER2/HER3 targeting antibody. Poziotinib is also referred to as IACS-070709, which is claimed in the examined application. Claim 3 of ‘713 claims the method of Claim 1 wherein the NRG1 fusions are identical to those claimed in the examined application. Claim 5 of ‘731 claims the method of Claim 1 wherein the HER2/HER3 targeting antibody is trastuzumab, pertuzumab, or T-DM1. Claim 7 of ‘731 claims the method of Claim 1 further comprising administering an anti-cancer therapy to the patient. Claim 8 of ‘731 claims the method of Claim 7 wherein the further anti-cancer therapy is a surgical therapy, chemotherapy, cryotherapy, hormonal therapy, toxin therapy, immunotherapy, or a cytokine therapy. Claim 9 of ‘731 claims the method of Claim 1 wherein the cancer is selected from several cancers which overlaps with those claimed in the examined application.
‘713 fails to teach the use of all compounds claimed in the examined application.
Lee (See IDS, 29 October 2024) teaches novel compounds for the inhibition of cancer cells induced by the overexpression of an EGFR, and the prevention of drug resistance caused by mutation to the EGFR tyrosine kinase (Abstract). Compounds of the invention include Example 24 (IACS-015293) (Page 88), Example 36 (IACS-070709) (Page 89), and Example 61 (IACS-070982) (Page 93).
Jones demonstrates the effectiveness of treating NRG1 fusion cancers with afatinib, a pan HER-tyrosine kinase inhibitor, and states that their results more broadly support the use of pan HER-tyrosine kinase inhibitors for the treatment of these cancers.
Ascertaining the Differences Between the Prior Art and the Claims at Issue:
‘713 does not disclose the specific TKIs of the examined application in combination with anti-HER2/HER3 antibodies, while Lee and Jones do not teach the combination of TKIs with anti-HER2/HER3 antibodies for the treatment of the claimed cancers.
Resolving the Level of Ordinary Skill in the Pertinent Art:
The artisan would be a medical doctor with extensive training in oncology, and in particular, the treatment of cancers which display the fusion events claimed in the examined application. Their training would involve the study of different pharmacotherapies, including different tyrosine kinase inhibitors.
Considering Objective Evidence Present in the Application Indicating Obviousness or Nonobviousness:
‘713, Lee, and Jones are considered analogous to the claimed invention as all are involved in the treatment of cancers which involve aberrant EGFR signaling using quinazoline-based tyrosine kinase inhibitors. Therefore, it would have been prima facie obvious to one of ordinary skill in the art the time of the effective filing date of the instant application to substitute the inhibitors of Lee for poziotinib as claimed in ‘731 as Jones states that their study supports the use of pan HER-tyrosine kinase inhibitors for the treatment of cancers with NRG1 fusions, providing a reasonable expectation of success for the artisan to perform this substitution. The use of the compounds of Lee in place of poziotinib is prima facie obvious simple substitution of one known element for another to obtain predictable results (See MPEP § 2143 I (B)), wherein the known elements are the TKI of Lee, substituted for the known TKI of ‘731, predictably resulting in an effective cancer treatment. This substitution is also prima facie obvious substitution of a known equivalent known for the same purpose (See MPEP § 2144.06 II); the artisan would recognize that the compounds of Lee are pan HER-TKIs, which serves the same purpose as poziotinib, and as Jones demonstrates, there would be a reasonable expectation that this substitution would be successful.
Regarding Claim 41, there is nothing which precludes the use of this treatment method in a patient who has undergone at least one round of anti-cancer therapy. The artisan would be motivated to apply this this treatment method to treat a patient who has undergone at least one round of anti-cancer therapy because that would indicate that the cancer was not responsive to the treatment, and thus would require a new treatment strategy.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 32, 33, 35, and 37-41 are rejected.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHILLIP MATTHEW RZECZYCKI whose telephone number is (703)756-5326. The examiner can normally be reached Monday Thru Friday 730AM-5PM EST.
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/P.M.R./Examiner, Art Unit 1625
/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625
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