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 18/864,541
This Office Action is responsive to the amended claims received 10 November 2024.
Claims 1-4 and 6-9 are currently pending.
Priority
Applicant’s claim for the benefit of the prior-filed applications KR 10-2022-0057026 (filed 10 May 2022) and KR 10-2023-0057627 (filed 3 May 2023) 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 10 May 2023, at least due to the lack of an English translation of the 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 statements (IDS) received on 2 June 2026, 28 August 2025, and 10 November 2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, these information disclosure statements are being considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 6-9 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claims contain subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Factors to be considered in making this determination include: (A) The breadth of the claims; (B) The nature of the invention; (C) The state of the prior art; (D) The level of one of ordinary skill; (E) The level of predictability in the art; (F) The amount of direction provided by the inventor; (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure. While all of these factors are considered, a sufficient number for a prima facie case are discussed below.
Claims 6-9 recite methods of preventing cancers through the administration of a composition of instant claim 6 or 9. All humans are susceptible to developing cancer. NCI (NIH National Cancer Institute, “Risk Factors for Cancer” 2015) teaches that cancer can be caused by inherited genetic mutations and via aging. It is not clear how the instantly claimed compounds could prevent the formation of cancer through these routes. The identity of the patient or patient population that one of ordinary skill in the art would choose to treat with a composition of instant claim 6 or 9, for the prevention of cancer, is entirely unclear. One of ordinary skill in the art would not reasonably read the instant claims and determine that all humans should be administered a composition of claim 6 or 9, regardless of their age, gender, or comorbidities. Therefore, the artisan would not know which humans should be administered the instantly claimed compounds. This represents an insufficient amount of direction provided by the inventor. Additionally, due to the low level of predictability in the chemical arts, one of ordinary skill in the art would not know if there would be unique risks to specific patient populations, such as pediatric or elderly patients.
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 1-4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by:
SUZUKI (Cited by Applicant in IDS of 10 November 2024; Suzuki, S.; Okada, M.; Kuramoto, K.; et al. “Aripiprazole, an Antipsychotic and Partial Dopamine Agonist, Inhibits Cancer Stem Cells and Reverses Chemoresistance” ANTICANCER RESEARCH 36: 5153-5162 (2016)).
SUZUKI teaches that aripiprazole is a drug widely used to treat patients with schizophrenia (3rd paragraph, Pg. 5153). Under the broadest reasonable interpretation, instant claim 1 only requires the step of administering a composition comprising aripiprazole to a subject. Claim 1 can reasonably be interpreted as a method of sensitizing a patient to the effect of an RAF inhibitor, wherein the patient may be administered such a drug in the future. SUZUKI teaches the practice of administering aripiprazole to patients to have been well known in the art. Claims 2 and 3 narrow the scope of the RAF inhibitor and anticancer effect of claim 1, but they do not require the patient to take such an inhibitor. Also, the anticancer effect of claim 1 does not appear to require the selection of a patient with a particular type of cancer, because claim 1 could be used as a preventative method wherein a cancer is combated by the pharmaceutical composition without the patient having any knowledge that the cancer has appeared.
Regarding claim 4: The outcomes within instant claim 4 are solely the result of administering the composition of claim 1 to a subject. There are no positive steps recited therein that would alter these outcomes unrelated to administering the composition of instant claim 1 to the subject. Therefore, because the method of administering the composition of instant claim 1 to the subject has been found to be anticipated, these direct outcomes must also be anticipated.
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 1-4 and 6-9 are rejected under 35 U.S.C. 103 as being unpatentable over:
SUZUKI (Cited by Applicant in IDS of 10 November 2024; Suzuki, S.; Okada, M.; Kuramoto, K.; et al. “Aripiprazole, an Antipsychotic and Partial Dopamine Agonist, Inhibits Cancer Stem Cells and Reverses Chemoresistance” ANTICANCER RESEARCH 36: 5153-5162 (2016))
in view of:
PLANCHARD (Planchard, D.; Besse, B.; Groen, H.J.M.; et al. “Phase 2 Study of Dabrafenib Plus Trametinib in Patients With BRAF V600E-Mutant Metastatic NSCLC: Updated 5-Year Survival Rates and Genomic Analysis” Journal of Thoracic Oncology August 2021, Vol. 17 No. 1: 103–115).
SUZUKI teaches that aripiprazole is a drug widely used to treat patients with schizophrenia (3rd paragraph, Pg. 5153). SUZUKI teaches that the A549 cell line, tested therein is a non-small cell lung cancer cell line (2nd Paragraph, Pg. 5154). Figure 1 of SUZUKI teaches that the NSCLC cells were selectively inhibited and caused to undergo cell death through the administration of aripiprazole. Figure 4 of SUZUKI teaches that aripiprazole sensitizes the A549 NSCLC stem cells to chemotherapeutic agents, such as gemcitabine. SUZUKI teaches that the results therein suggest that aripiprazole could be a promising drug candidate (discussion section).
SUZUKI does not specifically teach RAF inhibitors.
PLANCHARD teaches the results of a clinical trial that administered dabrafenib to patients with BRAF V600E-mutant metastatic non-small cell lung cancer (NSCLC) (abstract). PLANCHARD teaches that patients received 150 mg of dabrafenib twice daily and 2 mg of trametinib once daily (abstract). PLANCHARD teaches that the dabrafenib + trametinib therapy had a substantial clinical benefit (abstract).
It would have been obvious to one of ordinary skill in the art, before the instant effective filing date, to combine the aripiprazole therapy taught by SUZUKI for treating NSCLC with the dabrafenib + trametinib therapy taught by PLANCHARD to treat BRAF V600E-mutant NSCLC, for the purpose of increasing the anti-cancer efficacy of the therapy. The artisan would have expected success in this combination, because both drugs were taught to treat the same condition.
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.
Regarding claim 9: The definition of a “health functional food” within paragraph [28] of the instant specification is not a closed definition, and includes materials such as coloring agents, thickeners, and guar gum. One of ordinary skill in the art would assume that the administration of dabrafenib, within the treatment regimen section of PLANCHARD, did not consist of administering patients the pure drug itself. One of ordinary skill in the art would reasonably have assumed that the oral administration discussed in that section indicated administration of a tablet formulation, almost certainly with some type of coloring agent present therein.
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 1-4 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over:
Claim 17 of copending Application No. 19/680,198 (referred to below as the ‘198 application).
Although the claims at issue are not identical, they are not patentably distinct from each other because: As discussed in the rejections above, instant claims 1-4 only require the step of administering a composition comprising aripiprazole to a subject. Claim 17 of the ‘198 application claims a method that includes the administration of aripiprazole to a subject.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-4 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over:
Claim 1 of copending Application No. 18/864,544 (referred to below as the ‘544 application).
Although the claims at issue are not identical, they are not patentably distinct from each other because: As discussed in the rejections above, instant claims 1-4 only require the step of administering a composition comprising aripiprazole to a subject. Claim 1 of the ‘544 application claims a method that includes the administration of aripiprazole to a subject.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-4 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over:
Claim 1 of copending Application No. 18/864,542 (referred to below as the ‘542 application).
Although the claims at issue are not identical, they are not patentably distinct from each other because: As discussed in the rejections above, instant claims 1-4 only require the step of administering a composition comprising aripiprazole to a subject. Claim 1 of the ‘542 application claims a method that includes the administration of aripiprazole to a subject.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-4 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over:
Claim 1 of copending Application No. 18/864,540 (referred to below as the ‘540 application).
Although the claims at issue are not identical, they are not patentably distinct from each other because: As discussed in the rejections above, instant claims 1-4 only require the step of administering a composition comprising aripiprazole to a subject. Claim 1 of the ‘540 application claims a method that includes the administration of aripiprazole to a subject.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are currently allowable.
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.
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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
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