DETAILED ACTION
This is an initial Office action for non-provisional application 18/384952 filed October 30, 2023, which is a continuation of PCT/CN2022/117849 filed September 8, 2022, which claims foreign priority to CN202210189883.X filed February 28, 2022.
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.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Elections/Restrictions
In response to the restriction requirement mailed 2/12/26, it is acknowledged that applicant elected Invention I, encompassing claims 1-9 and 12-19 drawn to a method of treating without traverse. As such, the restriction requirement is deemed proper and made FINAL.
Claim Status
Claims 1-19 are pending. Claims 10-11 are withdrawn. Claims 1-9 and 12-19 are drawn to the elected species.
Claim Objections
Claims 12-15 are objected to because they are dependent on withdrawn claims 10-11 respectively. Thus, applicant’s correction is respectfully requested.
Claims 14-15 are objected to for the following reasons:
Claim 14, line 2 should recite “….to he subject in need thereof…”
Claim 15, line 2 should recite “….to he subject in need thereof…”
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.
Claims 1-9, 12-13 and 16-17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claims do not fall within at least one of the four categories of patent eligible subject matter because the claim is directed to neither a “product’ nor a “process" but rather embraces or overlaps two different statutory classes set forth in 35 U.S.C. 101 which is drafted so as to set forth the statutory classes in the alternative only (MPEP 2173.05(p) (II)). In the instant case, claims 1-9, 12-13 and 16-17 appear to embrace or overlap a product (a preparation comprising a medicament of acetytanshinone IIA) and a process for using the product (a method for treating lung cancer with a medicament of acetyltanshinone IIA).
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.
Claims 1-9, 12-13 and 16-19 are 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.
Claims 1-9, 12-13 and 16-17 are drawn to a preparation of a medicament with acetytanshinone IIA) and a process for using the product (a method for treating lung cancer with a medicament of acetyltanshinone IIA). A single claim that claims both a product and a method of using the product is ambiguous (MPEP 2173.05(p) (II)). For the purpose of examination on the merits and application of the prior art, claims 1-9, 12-13 and 16-17 will be interpreted as being drawn to a process for using the product (a method for treating lung cancer with a medicament of acetyltanshinone IIA).
Claims 16-19 recite that “…the non-small cell lung cancer comprises: adenocarcinoma, squamous cell carcinoma, and large cell carcinoma.” However, it is unclear if the claim is requiring the treatment of all three subtypes of non-small cell lung cancer (adenocarcinoma, squamous cell carcinoma and large cell carcinoma) and/or if the subject being administered treatment is required to have all three subtypes. Applicant’s clarification is respectfully requested. For purposes of examination, the claim will be interpreted as just requiring the treatment of one of the three subtypes.
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.
Claims 2-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Luo et al (US 2014/0080796; cited in PTO-892 herein).
Regarding claim 2, the claim will be interpreted as a method of treating non-small lung cancer that comprises administering a preparation comprising acetyltanshinone IIA that acts as a non-small cell lung cancer cell growth inhibitor. Luo et al disclose anti-cancer therapy and the treatment and prevention of various types of cancer via administration of acetyltanshinone IIA (paragraph 0002). More specifically, Luo et al assessed the cytotoxicity of acetyltanshinone IIA in multiple cancer cells including A549 lung cancer cells (paragraph 0138, Example 8). As evidenced by the instant specification (see paragraph 0053 in published application), A549 cells are known as non-small lung cancer cells that are of the adenocarcinoma subtype. Thus, since Luo et al teach the administration of acetyltanshinone IIA to non-small cell lung cancer cells, the treatment of lung cancer and the inhibition of non-small lung cancer cell growth would naturally result from Luo’s teachings. See MPEP 2112.02. The discovery of a new use for an old structure based on unknown properties of the structure might be patentable to the discoverer as a process of using. In re Hack, 245 F.2d 246, 248, 114 USPQ 161, 163 (CCPA 1957). However, when the claim recites using an old composition or structure and the "use" is directed to a result or property of that composition or structure, then the claim is anticipated. In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978).
Regarding claim 3, the claim will be interpreted as a method of treating non-small lung cancer that comprises administering a preparation comprising acetyltanshinone IIA that acts as a H358 cell growth inhibitor, a H1975 cell growth inhibitor, and/or a H1650 cell growth inhibitor. As discussed above, Luo et al teach the administration of acetyltanshinone IIA to non-small cell lung cancer cells. Since the claim does not specifically require administration to H358, H1975 and/or H1650 cells, the inhibition of H358 cell growth, H1975 cell growth and/or H1650 cell growth would naturally result from Luo’s teachings and the medicament of Luo et al would be capable of inhibiting H358, H1975 and/or H1650 cell growth. See MPEP 2112.02. The discovery of a new use for an old structure based on unknown properties of the structure might be patentable to the discoverer as a process of using. In re Hack, 245 F.2d 246, 248, 114 USPQ 161, 163 (CCPA 1957). However, when the claim recites using an old composition or structure and the "use" is directed to a result or property of that composition or structure, then the claim is anticipated. In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978).
Regarding claims 4-6, the claims will be interpreted as a method of treating non-small lung cancer that comprises administering a preparation comprising acetyltanshinone IIA that acts as a protein synthesis inhibitor and more specifically, a cell cycle-related protein synthesis inhibitor or an inhibitor of p70S6K, cyclin D3, AURKA, PLK1, cyclin B1, survivin, EGFR or MET. As discussed above, Luo et al teach the administration of acetyltanshinone IIA to non-small cell lung cancer cells. Thus, the treatment of lung cancer and inhibition of protein synthesis including cell cycle-related protein synthesis or inhibition of p70S6K, cyclin D3, AURKA, PLK1, cyclin B1, survivin, EGFR or MET would naturally result from Luo’s teachings. See MPEP 2112.02. The discovery of a new use for an old structure based on unknown properties of the structure might be patentable to the discoverer as a process of using. In re Hack, 245 F.2d 246, 248, 114 USPQ 161, 163 (CCPA 1957). However, when the claim recites using an old composition or structure and the "use" is directed to a result or property of that composition or structure, then the claim is anticipated. In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978).
Regarding claims 7-8, the claims will be interpreted as a method of treating non-small lung cancer that comprises administering a preparation comprising acetyltanshinone IIA that acts as a phosphorylation inhibitor and more specifically, a phosphorylation inhibitor of p70S6K and/or S6RP. As discussed above, Luo et al teach the administration of acetyltanshinone IIA to non-small cell lung cancer cells. Thus, the treatment of lung cancer and inhibition of phosphorylation and more specifically, inhibiting p70S6 and/or S6RP would naturally result from Luo’s teachings. See MPEP 2112.02. The discovery of a new use for an old structure based on unknown properties of the structure might be patentable to the discoverer as a process of using. In re Hack, 245 F.2d 246, 248, 114 USPQ 161, 163 (CCPA 1957). However, when the claim recites using an old composition or structure and the "use" is directed to a result or property of that composition or structure, then the claim is anticipated. In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978).
Regarding claim 9, the claim will be interpreted as a method of treating non-small lung cancer that comprises administering a preparation comprising acetyltanshinone IIA that acts as a p21 transcriptional activator or p53 promoter. As discussed above, Luo et al teach the administration of acetyltanshinone IIA to non-small cell lung cancer cells. Thus, the treatment of lung cancer and the medicament acting as a p21 transcriptional activator or p53 promoter would naturally result from Luo’s teachings. See MPEP 2112.02. The discovery of a new use for an old structure based on unknown properties of the structure might be patentable to the discoverer as a process of using. In re Hack, 245 F.2d 246, 248, 114 USPQ 161, 163 (CCPA 1957). However, when the claim recites using an old composition or structure and the "use" is directed to a result or property of that composition or structure, then the claim is anticipated. In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978).
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.
Claims 1 and 12-19 are rejected under 35 U.S.C. 103 as being unpatentable over Luo et al (US 2014/0080796; cited in PTO-892 herein) in view of Jiang et al (Oncology Reports 36: pp. 365-375, 2016; cited in PTO-892 herein).
Regarding claims 1 and 12-13, the claims will be interpreted as a method of treating lung cancer that comprises administering a preparation comprising acetyltanshinone IIA wherein the lung cancer is non-small cell lung cancer caused by KRAS activating mutation or PTEN deletion. Luo et al disclose anti-cancer therapy and the treatment and prevention of various types of cancer via administration of acetyltanshinone IIA (paragraph 0002). More specifically, Luo et al assessed the cytotoxicity of acetyltanshinone IIA in multiple cancer cells including A549 lung cancer cells (paragraph 0138, Example 8). As evidenced by the instant specification (see paragraph 0053 in published application), A549 cells are known as non-small lung cancer cells that are of the adenocarcinoma subtype. Luo et al also teach a second anticancer agent can be administered in addition to acetyltanshinone IIA (paragraphs 0069-0072). Luo et al teach its treatment with acetyltanshinone IIA enhances the effectiveness of conventional treatment forms (i.e., second anticancer agents including gefitinb, tamoxifen, etc., see paragraph 0071) in which the conventional treatment developed resistance and is considered less effective (paragraph 0077). Thus, although Luo et al teach the administration of acetyltanshinone IIA to non-small cell lung cancer cells, Luo et al do not explicitly teach the administration of acetyltanshinone IIA to non-small cell lung cancer cells that have a KRAS activating mutation or PTEN mutation.
Jiang et al teach KRAS and EGFR mutations are the two most common driver mutations in non-small cell lung cancer (abstract). More specifically, non-small cell lung cancer cell lines that harbor KRAS mutations include A549 cells (abstract; pg. 366, second column). Such mutations can result in drug resistance in anticancer therapies like gefitinib (abstract; pg. 374, Discussion).
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date to administer Luo’s medicament of acetyltanshinone IIA to non-small lung cancer cells including A549 cells with KRAS mutations. A skilled artisan would have been motivated to do so since KRAS mutations are a common mutation in non-small cell lung cancer cells according to Jiang et al. Further, a skilled artisan would have a reasonable expectation to do so since Luo et al leads a skilled artisan to believe that acetyltanshinone IIA is more effective against mutated cancer cells than conventional therapies (i.e., gefitnib)
Regarding claims 14-15, Luo et al disclose anti-cancer therapy and the treatment and prevention of various types of cancer via administration of acetyltanshinone IIA (paragraph 0002). More specifically, Luo et al assessed the cytotoxicity of acetyltanshinone IIA in multiple cancer cells including A549 lung cancer cells (paragraph 0138, Example 8). As evidenced by the instant specification (see paragraph 0053 in published application), A549 cells are known as non-small lung cancer cells that are of the adenocarcinoma subtype. Luo et al also teach a second anticancer agent can be administered in addition to acetyltanshinone IIA (paragraphs 0069-0072). Luo et al teach its treatment with acetyltanshinone IIA enhances the effectiveness of conventional treatment forms (i.e., second anticancer agents including gefitinb, tamoxifen, etc., see paragraph 0071) in which the conventional treatment developed resistance and is considered less effective (paragraph 0077). Thus, although Luo et al teach the administration of acetyltanshinone IIA to non-small cell lung cancer cells, Luo et al do not explicitly teach the administration of acetyltanshinone IIA to non-small cell lung cancer cells that have a KRAS activating mutation or PTEN mutation.
Jiang et al teach KRAS and EGFR mutations are the two most common driver mutations in non-small cell lung cancer (abstract). More specifically, non-small cell lung cancer cell lines that harbor KRAS mutations include A549 cells (abstract; pg. 366, second column). Such mutations can result in drug resistance in anticancer therapies like gefitinib (abstract; pg. 374, Discussion).
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date to administer Luo’s medicament of acetyltanshinone IIA to non-small lung cancer cells including A549 cells with KRAS mutations. A skilled artisan would have been motivated to do so since KRAS mutations are a common mutation in non-small cell lung cancer cells according to Jiang et al. Further, a skilled artisan would have a reasonable expectation to do so since Luo et al leads a skilled artisan to believe that acetyltanshinone IIA is more effective against mutated cancer cells than conventional therapies (i.e., gefitnib).
Regarding claims 16-19, Luo et al teach A549 cells are known as non-small lung cancer cells that are of the adenocarcinoma subtype (paragraph 0138, Example 8).
Conclusion
Claims 1-9 and 12-19 are rejected. No claims are allowed.
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/RACHAEL E BREDEFELD/Supervisory Patent Examiner, Art Unit 3786