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 .
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.
Current Status of 18/489,722
This Office Action is responsive to the amended claims received 1 December 2025.
Claims 1-6 are currently pending.
Priority
Applicant’s claim for the benefit of the prior-filed applications 16/754,266 (filed 7 April 2020), PCT/JP2018/038202 (filed 12 October 2018), and JP 2017-199598 (13 October 2017) under 35 U.S.C. 119(e), 120, 121, 365(c), or 386(c) is acknowledged.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
The Examiner has determined, for the purposes of the instant action, that the effective filing date of the instant claims is 20 April 2020, at least due to the lack of an English translation of an earlier priority document. Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Information Disclosure Statement
The information disclosure statement (IDS) received on 18 October 2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, this information disclosure statement is being considered by the examiner.
Response to Amendments
The 35 U.S.C. 112 rejections to the claims, present in the previous office action, are hereby withdrawn due to Applicant’s amendments. New rejections are presented herein.
New rejections under 35 U.S.C. 102(a)(1) and/or 35 U.S.C. 102(a)(2) are presented herein.
The 35 U.S.C. 103 rejections to the claims, present in the previous office action, are maintained herein.
New nonstatutory double patenting rejections are presented herein.
Response to Arguments
Applicant argues that In re Crokett is not applicable to the present claims. Applicant argues that the compounds instantly claimed were not both known to treat the instantly claimed condition before the instant effective filing date. Applicant argues that cancer is unpredictable. Applicant argues that the synergism instantly demonstrated, within the specification, argues for the unexpected nature of the instant results. Applicant argues that synergy of similar drugs has not been demonstrated.
The Examiner no longer relies on In re Crokett. INUKAI and ASTRAZENECA each teach one of the instantly claimed compounds to be useful in the treatment of NSCLC. Cancer is unpredictable, and the Examiner is not discounting the synergistic effect claimed by Applicant. However, the fact that both compounds were clearly taught to treat the same condition, being NSCLC, would reasonably lead one of ordinary skill in the art to combine them into a single combination treatment (as discussed below). Applicant may choose to submit a declaration or affidavit from someone having relevant experience to argue why this combination would not have been obvious.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 4 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 4 recites “The therapeutic agent according to claim 3”. However, claim 3 is directed to a “therapeutic combination”. The “therapeutic agent” of claim 4 lacks antecedent basis, as it was not introduced earlier in the claim or the parent claim. This renders claim 4 indefinite. Applicant may choose to amend claim 4 to recite “The therapeutic combination”.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by:
INUKAI (US 2016/0168121 A1; Effective Filing Date 24 July 2013).
INUKAI teaches the following compound to be an Axl inhibitor, which is useful for treating all Axl-related diseases, for example, non-small cell lung cancer (NSCLC) (Example 5, paragraph [0042], and claims 6 and 11).
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The compound of Example 5 of INUKAI is identical to the compound claimed within instant claim 1. Instant claim 1 recites “A therapeutic agent… comprising an Axl inhibitor to be administered in combination with Osimertinib”. It is the Examiner’s interpretation that instant claims 1 and 2 require only the specific Axl inhibitor therein, which has the therapeutic abilities required therein. And, as the therapeutic abilities are solely the result of the structure of the compound, instant claims 1 and 2 only require the specific Axl inhibitor therein. One of ordinary skill in the art would likely interpret claims 1 and 2 not to require the combination of the Axl inhibitor therein and osimertinib, because instant claims clearly 3-6 require that specific combination.
Claim Rejections - 35 USC § 103
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over:
INUKAI (US 2016/0168121 A1; Effective Filing Date 24 July 2013)
in view of:
ASTRAZENECA (Tagrisso (Osimertinib) Prescribing Information, 2015).
INUKAI teaches the following compound to be an Axl inhibitor, which is useful for treating all Axl-related diseases, for example, non-small cell lung cancer (NSCLC) (Example 5, paragraph [0042], and claims 6 and 11).
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The compound of Example 5 of INUKAI is identical to the compound claimed within instant claim 1. INUKAI specifies the compound above to be one of the “more preferable” examples described in paragraphs [0072]-[0073] and [0203]. INUKAI also teaches that the compounds therein may include any possible isomers, stereoisomers, racemates, salts and hydrates (paragraphs [0090] and [0093]-[0094]). INUKAI teaches that the compounds therein can be administered in combination with various anti-cancer drugs (paragraphs [0042], [0135], and [0140]-[0141]). INUKAI teaches that the compounds therein may be administered as combination therapies for the purpose of: enhancing the therapeutic effect or the kinetics of the compounds, improving absorption, and/or to reducing the required dose and eliminating side effects of drugs (paragraph [0140]). INUKAI teaches gefitinib to be a tyrosine kinase inhibitor and an example of EGFR inhibitor (paragraph [0158]). Paragraph [0181] of INUKAI teaches the combination of an active ingredient therein with a vehicle, such as mannitol.
INUKAI does not teach the combination of the Example 5 compound therein and osimertinib.
ASTRAZENECA teaches osimertinib to be useful in the treatment of EGFR mutation-positive NSCLC. ASTRAZENECA teaches osimertinib as a treatment for patients with metastatic NSCLC, particularly patients who present with metastatic EGFR T790 mutation-positive NSCLC, wherein the disease has progressed during or after EGFR tyrosine kinase inhibitor (TKI) therapy (indications and usage section).
It would have been obvious to one of ordinary skill in the art, before the instant effective filing date, to combine the compound taught by INUKAI to be effective against NSCLC with osimertinib, taught by ASTRAZENECA to be a standard therapeutic agent for NSCLC. The artisan would have expected success in this combination, because both compounds are taught to be effective to treat the same condition, being NSCLC.
This is an example of combining equivalent therapeutic agents known to be useful for the same purpose. “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). See MPEP 2144.06.
The therapeutic effects of the compounds within the instant claims are solely the result of the chemical structures of the compounds. Because the structures of Example 5 of INUKAI and the osimertinib of ASTRAZENECA are identical to the instantly claimed compounds, the compounds of INUKAI and ASTRAZENECA, and combinations thereof, must produce the therapeutic effects as instantly claimed.
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 1-6 are rejected on the ground of nonstatutory double patenting as being unpatentable over:
Claim 1 of U.S. Patent No. 11,826,363 B2 (referred to below as the ‘363 patent).
Claim 1 of the ‘363 patent teaches a method of treating an EGFR inhibitor resistant non-small cell lung cancer in a subject in need thereof through the administration of N-{5-[(6,7-dimethoxy-4-quinolinyl)oxy]-2-pyridinyl}-2,5-dioxo-1-phenyl-1,2,5,6,7,8-hexahydro-3-quinolinecarboxamide in combination with osimertinib.
Claims 1-2 are rejected on the ground of nonstatutory double patenting as being unpatentable over:
Claim 8 of U.S. Patent No. 10,836,747 B2 (referred to below as the ‘747 patent).
Claim 8 of the ‘747 patent teaches a method of treating an Axl-related disease through the administration of N-{5-[(6,7-dimethoxy-4-quinolinyl)oxy]-2-pyridinyl}-2,5-dioxo-1-phenyl-1,2,5,6,7,8-hexahydro-3-quinolinecarboxamide.
It is the Examiner’s interpretation that instant claims 1 and 2 require only the specific Axl inhibitor therein, which has the therapeutic abilities required therein. And, as the therapeutic abilities are solely the result of the structure of the compound, instant claims 1 and 2 only require the specific Axl inhibitor therein. One of ordinary skill in the art would likely interpret claims 1 and 2 not to require the combination of the Axl inhibitor therein and osimertinib, because instant claims 3-6 require that specific combination.
Claims 1-2 are rejected on the ground of nonstatutory double patenting as being unpatentable over:
Claim 1 of U.S. Patent No. 10,208,022 B2 (referred to below as the ‘022 patent).
Claim 1 of the ‘022 patent teaches a method of treating an Axl-related disease through the administration of N-{5-[(6,7-dimethoxy-4-quinolinyl)oxy]-2-pyridinyl}-2,5-dioxo-1-phenyl-1,2,5,6,7,8-hexahydro-3-quinolinecarboxamide.
It is the Examiner’s interpretation that instant claims 1 and 2 require only the specific Axl inhibitor therein, which has the therapeutic abilities required therein. And, as the therapeutic abilities are solely the result of the structure of the compound, instant claims 1 and 2 only require the specific Axl inhibitor therein. One of ordinary skill in the art would likely interpret claims 1 and 2 not to require the combination of the Axl inhibitor therein and osimertinib, because instant claims 3-6 require that specific combination.
Claims 1-2 are rejected on the ground of nonstatutory double patenting as being unpatentable over:
Claim 1 of U.S. Patent No. 10,501,442 B2 (referred to below as the ‘442 patent).
Claim 1 of the ‘442 patent teaches a pharmaceutical composition including N-{5-[(6,7-dimethoxy-4-quinolinyl)oxy]-2-pyridinyl}-2,5-dioxo-1-phenyl-1,2,5,6,7,8-hexahydro-3-quinolinecarboxamide.
It is the Examiner’s interpretation that instant claims 1 and 2 require only the specific Axl inhibitor therein, which has the therapeutic abilities required therein. And, as the therapeutic abilities are solely the result of the structure of the compound, instant claims 1 and 2 only require the specific Axl inhibitor therein. One of ordinary skill in the art would likely interpret claims 1 and 2 not to require the combination of the Axl inhibitor therein and osimertinib, because instant claims 3-6 require that specific combination.
Claims 1-2 are rejected on the ground of nonstatutory double patenting as being unpatentable over:
Claims 1 and 3 of U.S. Patent No. 10,676,462 B2 (referred to below as the ‘462 patent).
Claims 1 and 3 of the ‘462 patent teach a method of preparing the following compound: N-{5-[(6,7-dimethoxy-4-quinolinyl)oxy]-2-pyridinyl}-2,5-dioxo-1-phenyl-1,2,5,6,7,8-hexahydro-3-quinolinecarboxamide.
It is the Examiner’s interpretation that instant claims 1 and 2 require only the specific Axl inhibitor therein, which has the therapeutic abilities required therein. And, as the therapeutic abilities are solely the result of the structure of the compound, instant claims 1 and 2 only require the specific Axl inhibitor therein. One of ordinary skill in the art would likely interpret claims 1 and 2 not to require the combination of the Axl inhibitor therein and osimertinib, because instant claims 3-6 require that specific combination.
Claims 1-2 are rejected on the ground of nonstatutory double patenting as being unpatentable over:
Claim 1 of U.S. Patent No. 9,573,935 B2 (referred to below as the ‘935 patent).
Claim 1 of the ‘935 patent specifically claims following compound and salts thereof: N-{5-[(6,7-dimethoxy-4-quinolinyl)oxy]-2-pyridinyl}-2,5-dioxo-1-phenyl-1,2,5,6,7,8-hexahydro-3-quinolinecarboxamide.
It is the Examiner’s interpretation that instant claims 1 and 2 require only the specific Axl inhibitor therein, which has the therapeutic abilities required therein. And, as the therapeutic abilities are solely the result of the structure of the compound, instant claims 1 and 2 only require the specific Axl inhibitor therein. One of ordinary skill in the art would likely interpret claims 1 and 2 not to require the combination of the Axl inhibitor therein and osimertinib, because instant claims 3-6 require that specific combination.
Conclusion
No claims are currently allowable.
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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 JOHN D MCANANY whose telephone number is (571)270-0850. The examiner can normally be reached 8:30 AM - 5:30 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, ANDREW D KOSAR can be reached at (571)272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JDMc/Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625