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
Applicant’s election without traverse of Group II, claims 29-40, as well as the species: 1) a PD-1 inhibitor as the specific immune checkpoint inhibitor; 2) toripalimab as the specific PD-1 inhibitor; 3) colon cancer as the specific cancer, in the reply filed on December 29, 2025 is acknowledged.
Claims 1-20 were previously canceled.
Claims 21-40 are pending.
Claims 21-28, 34 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions or species, there being no allowable generic or linking claim.
Claims 29-33, and 35-40 are pending and under consideration.
Priority
It is acknowledged that this application is a 371 of International Application No. PCT/CN2021/116498 filed September 3, 2021, which claims the benefit of priority to Chinese Patent Application No. 202010939961.4 filed September 9, 2020. Priority date has been established as September 9, 2020.
Certified copies of foreign priority applications have been received as required by 37 CFR 1.55.
Information Disclosure Statement
The Information Disclosure Statements filed on 03/08/2023 and 01/02/2026 have been considered and entered by examiner.
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 29-33 and 35-40 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.
Claim 29 recites the limitation "a tumor of the subject" in line 2. There is insufficient antecedent basis for this limitation (“the subject”) in the claim.
Claim 29 recites “a derivative thereof” which renders the claim indefinite. The specification does not provide a standard for determining whether a compound is a derivative of chiauranib or not. The claim or the specification does not give any indication as to the structure of the compound defined as “a derivative of a chiauranib”. Thus, one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Section 2171 of the M.P.E.P. states
Two separate requirements are set forth in 35 U.S.C. 112(b) and pre-AIA 35 U.S.C. 112, second paragraph, namely that:
(A) the claims must set forth the subject matter that the inventor or a joint inventor regards as the invention; and
(B) the claims must particularly point out and distinctly define the metes and bounds of the subject matter to be protected by the patent grant.
The first requirement is a subjective one because it is dependent on what the inventor or a joint inventor for a patent regards as his or her invention. Note that although pre-AIA 35 U.S.C. 112, second paragraph, uses the phrase "which applicant regards as his invention," pre-AIA 37 CFR 1.41(a) provides that a patent is applied for in the name or names of the actual inventor or inventors.
The second requirement is an objective one because it is not dependent on the views of applicant or any particular individual, but is evaluated in the context of whether the claim is definite — i.e., whether the scope of the claim is clear to a hypothetical person possessing the ordinary level of skill in the pertinent art.
In the instant case of “a derivative thereof”, one of skill in the art could find representative examples in the art which have been defined in such terms, however, it is unclear at what point one of skill in the art would be infringing on the claims without limitations as to the metes and bounds of a derivative of chiauranib and the amount of deviation acceptable under the term of a derivative of chiauranib.
Claims 30-33 and 35-40 are also rejected because these claims depend on claim 29.
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 29, 31-33, and 35-40 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 written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a WRITTEN DESCRIPTION rejection.
Claim 29 is drawn to a method for treating a tumor of the subject, comprising administering a therapeutically effective amount of a first component of, a chiauranib or a derivative thereof, or a pharmaceutical acceptable salt thereof; and a second component of an immune checkpoint inhibitor, to the subject. The specification does not clearly define the term: a derivative of chiauranib. Given Broadest Reasonable Interpretation (BRI), the derivative of chiauranib would encompass all compounds related structurally to chiauranib and theoretically derivable from it and all compounds can be made from chiauranib. Thus, a derivative of chiauranib may not have the complete structure of chiauranib or may be a degraded product from chiauranib. Paragraph [0025] of the instant publication US 2023/0321074 A1 states: “the chiauranib derivatives includes a pharmaceutically acceptable salt thereof and non-solvated crystals A, B, and C thereof”, which all have complete structure of chiauranib. However, “a derivative of chiauranib” is not limited by the examples of Paragraph [0025].
The instant specification provides evidence of the therapeutic activity of chiauranib:
Example 1, Fig. 2, shows that combined use of anti-PD-1 antibody and chiauranib significantly increase the relative tumor inhibition rate to 70% in a CT-26 model (a colon-cancer) (see [0083] of the instant publication).
The combination of anti-PD-1 antibody and chiauranib has an enhanced antitumor activity in a H22-tumor (liver cancer) model (Table 2, and [0090] of the instant publication).
The combination of anti-PD-L1 antibody and chiauranib has an enhanced antitumor activity in an MC38-tumor (a colon cancer) model (Table 5 and Table 8).
Taken together, the specification teaches anti-tumor activity for chiauranib alone or in combination with an immune checkpoint inhibitor (such as anti-PD-1 antibody or anti-PD-L1 antibody). Thus, the specification lacks written description support for the broadly claimed methods which encompass a broad genus of derivatives of chiauranib.
Vas-Gath, Inc. v" Mahurkar, 19 USPQ2d 1111, makes clear that "to satisfy the written description requirement, an applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention, and that the invention, in that context, is whatever is now claimed".
For a claim encompassing to a genus, a generic statement that defines a genus of substances by only their functional activity does not provide an adequate written description of the genus. Reagents of the University of California v. Eli Lilly, 43 USPQ2d 1398 (CAFC 1997). The recitation of afunctional property alone, which must be shared by the members of the genus, is merely descriptive of what the members of the genus must be capable of doing, not of the substance and structure of the members. The Federal Circuit has cautioned that, for claims reciting a genus of antibodies with particular functional properties (e.g., binding to antigen, high affinity, neutralization activity, competing with a reference antibody for binding), “[claiming antibodies with specific properties, e.g., an antibody that binds to human TNF-a with A2 specificity, can result in a claim that does not meet written description even if the human TNF-a protein is disclosed because antibodies with those properties have not been adequately described." Centocor Ortho Biotech Inc. v. Abbott Labs., 97 USPQ2d 1870, 1875, 1877-78 (Fed. Cir. 2011).
Regarding derivatives of chiauranib, the specification has not provided a sufficient description about the correlation between the recited functions (such as treating cancers) and the structure of derivatives. One of ordinary skill in the art would not be able to quickly visualize/recognize which derivatives of chiauranib would function as chiauranib for treating cancers, except those with complete structure of chiauranib, such as a pharmaceutically acceptable salt of chiauranib and non-solvated crystals A, B, and C of chiauranib.
Also, it is noted that the Court has held that the disclosure of screening assays and general classes of compounds was not adequate to describe compounds having the desired activity: without disclosure of which peptides, polynucleotides, or small organic molecules have the desired characteristic, the claims failed to meet the description requirement of§ 112. See University of Rochester v. G.D. Searle & Co., Inc., 69 USPQ2d 1886,1895 (Fed. Cir. 2004). Meeting the written description threshold requires showing that the applicant was in "possession" of the claimed invention at the time of filing. Vas-Cath, 935 F.2d at 1563-1564. Support need not describe the claimed subject matter in exactly the same terms as used in the claims. Eiselstein v. Frank, 52 F.3d 1035, 1038 (Fed. Cir. 1995). This support cannot be based on obviousness reasoning - i.e., what the written description and knowledge in the art would lead one to speculate as to modifications the inventor might have envisioned, but failed to disclose. Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997). Ariad points out, the written description requirement also ensures that when a patent claims a genus by function, the specification recites sufficient materials to accomplish that function - a problem that is particularly acute in biological arts." Ariad, 598 F.3d at 1352-3. Note the following Court Decisions regarding the written description of antibodies in the context of the current claims. Given the claimed broadly class of antibody binding domains, in the absence of sufficient disclosure of relevant identifying characteristics, the patentee must establish "a reasonable structure-function correlation" either within the specification or by reference to the knowledge of one skilled in the art with functional claims. AbbVie Deutsch/and GmbH & Co. v. Janssen Biotech, Inc. (Fed. Cir. 2014) and the specification at best describes plan for making antibodies with the "limitations above" and then identifying those that satisfy claim limitations, but mere "wish or plan" for obtaining claimed invention is not sufficient. Centocor Ortho Biotech Inc. v. Abbott Laboratories, 97 USPQ2d 1870 (Fed. Cir. 2011). There is insufficient written description of the required kind of structure-identifying information about the corresponding makeup of the claimed antibody binding domains to demonstrate possession. Also, see Amgen Inc. v. Sanofi, Aventisub LLC, No. 2017-1480 (Fed. Cir. 2017).
Claims 31-33, and 35-40 depend on claim 29 and also encompass a broad genus of derivatives of chiauranib. Thus, these claims also lack written description support.
Claim Rejections - 35 USC § 102
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 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 29, 31-33, 35, 36, and 38-40 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yang (Yang et al., WO 2019/096194 A1, Publication Date: 05/23/2019, cited in IDS of 03/08/2023), as evidenced by definition of Toripalimab (downloaded from: https://www.cancer.gov/publications/dictionaries/cancer-drug/def/toripalimab, on 02/03/2026).
Yang teaches the method of using a combination of a VEGFR inhibitor and an anti-PD-1 antibody or an antigen-binding fragment thereof for treating patients with small cell lung cancer (claim 1).
Yang teaches the VEGFR inhibitor is a VEGFR-2 inhibitor, such as chiauranib (claims 2 and 3).
Yang teaches the antibody in the combination can be pembrolizumab, nivolumab, JS-001 (claim 5). JS-001 is identical to toripalimab (the elected species), as evidenced by Toripalimab.
Yang teaches co-administering the combination (claim 17).
Yang teaches a method for treating tumor/cancer, comprising administering the anti-PD-1 antibody and the VEGFR inhibitor ([0049] of the English translation).
Taken together, Yang teaches the method of instant claim 29.
Regarding claim 31, Yang teaches the dose of VEGFR inhibitor can be 1 mg, 2 mg, 3 mg, 4 mg, 5 mg, 6mg, 7mg, 8mg, 9mg, 10mg, 11mg, 12mg, 12.5mg, 15mg, 17.5mg, 20mg, 22.5mg, 25mg, 30mg, 45mg, 50mg, 60mg, 70mg,75mg, 80mg, 90mg, 100mg (claim 16), which reads the range of 1 to 100 mg as instantly claimed.
Regarding claim 32 and 33, JS-001 (toripalimab, the elected species) reads on these claims.
Regarding claim 35, Yang teaches the dose of PD-1 antibody is 50-600 mg (claim 15), which reads on the range of 1-1000 mg as instantly claimed.
Regarding claim 36, small cell lung cancer reads on lung cancer.
Regarding claim 38-39, Yang teaches In a preferred embodiment of the present invention, when administering, the dosage of the PD-1 antibody is 60 to 600 mg, intravenous infusion, once every three weeks; the dosage of the VEGFR inhibitor is 250 mg to 500 mg, orally, once every one to two days ([0040] of English translation on page 7); or in a preferred embodiment of the present invention, when administering, the dosage of the PD-1 antibody is 200 mg, intravenous infusion, once every two weeks; the dosage of the VEGFR inhibitor is 375 mg, orally, once a day ([0043] of English translation on page 7).
Regarding claim 40, as shown above, PD-1 antibody is administered once every two weeks; VEGFR inhibitor is administered once a day, thus, the first component and the second component are administered separately.
Claims 29, 32, 35-40 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chen (Chen et al., WO 2018/223923 A1, Publication Date: 12/13/2018, English translation, cited in IDS of 03/08/2023), as evidenced by Chiauranib_PubChem (downloaded from: https://pubchem.ncbi.nlm.nih.gov/compound/Ibcasertib, on 02/03/2026).
Chen teaches that blocking PD-1/PD-L1 has become a potent treatment for cancer immunotherapy ([0003] of English translation).
Chen teaches although the anti-PD-1 antibody has achieved remarkable effect on tumor suppression, it is not effective for some patients ([0004] of English translation).
Chen teaches an anti-PD-1 antibody comprising light chain of SEQ ID NO: 8 and heavy chain of SEQ ID NO: 7 ([0024] of English translation, and claim 6).
Chen teaches using the combination of the anti-PD-1 antibody and VEGF inhibitor (such as CS-2164) for treating cancer ([0033] of the English translation, claims 1 and 7). As evidenced by Chiauranib_PubChem (see page 1), CS-2164 is the same as chiauranib.
Chen teaches a method for treating means administering a therapeutic agent internally or externally ([0066] of the English translation).
Chen teaches the administration mode of the combination, including simultaneously administration, independently preparation and co-administration or independently preparation and sequential administration ([0045] of the English translation).
Taken together, Chen teaches the method of instant claim 29.
Regarding claim 35, Chen teaches that preferably, the dose of PD-1 antibody is 25mg, 40 mg, 50 mg, 60 mg, 75 mg, 100 mg, 150 mg, 200 mg, 250 mg, 300 mg, 400 mg, 500 mg, 750 mg, 800 mg, 1000mg, which reads on the range of 1-1000 mg as instantly claimed.
Regarding claims 36 and 37, Chen teaches that the cancers can be colon cancer (the elected species) or liver cancer ([0037] and [0036] of English translation, claims 8 and 9).
Regarding claims 38 and 39, Chen teaches that administration route of the PD-1 antibody or antigen-binding fragment thereof is preferably a parenteral administration route, more preferably intravenous injection, intramuscular injection, or subcutaneous injection. This reads on “parentally administering the second component” of claim 38 and “injecting the second component” of claim 39.
Regarding claim 40, Chen teaches the administration mode of the combination, including simultaneously administration, independently preparation and co-administration or independently preparation and sequential administration ([0045] of the English translation).
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.
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.
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Yang (Yang et al., WO 2019/096194 A1, Publication Date: 05/23/2019, English translation, cited in IDS of 03/08/2023), as evidenced by definition of Toripalimab (downloaded from: https://www.cancer.gov/publications/dictionaries/cancer-drug/def/toripalimab, on 02/03/2026), as applied to claims 29, 31-33, 35, 36, and 38-40 above, and further in view of Lu (Lu et al., CN 107868044 A, Publication Date: 04/03/2018, English translation, cited in IDS of 03/08/2023), as evidenced by Chiauranib_PubChem (downloaded from: https://pubchem.ncbi.nlm.nih.gov/compound/Ibcasertib, on 02/03/2026).
Yang teaches method of instant claim 29 as set forth above. However, Yang does not teach a non-solvated crystal of chiauranib as recited by claim 30.
Lu teaches non-solvated crystals of N-(2-aminophenyl)-6- (7-methoxyquinoline-4-oxygen)-1-naphthylcarboxamide ([0002] and [0004] of English translation). Based on paragraphs [0002] and [0003] of the original publication (CN 107868044 A), the compound has a structure as shown below:
PNG
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176
300
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Greyscale
As evidenced by Chiauranib in PubChem (see page 4), the compound of formula (I) is the same as chiauranib.
Lu teaches that the crystal of the compound of formula (I) made by previous method contains N.N-dimethylformamide (DMF) ([0007] of English translation). Due to the potential toxicity of organic solvents to drug users, it is generally not suitable to prepare crystals containing organic solvents ([0008] of English translation).
Lu teaches three non-solvated crystals of the compound of formula (I) ([0012], claim 2).
Lu teaches that the non-solvated crystal A has characteristic peaks at 6.88°, 9.26°, 12.74°, 13.82°, 18.58°, 20.86° and 25.72° in its X-ray powder diffraction pattern at reflection angles 2θ (claim 2); the non-solvated crystal B has characteristic peaks at 4.88°, 9.68°, 12.74 °, 14.52°, 17.72°, 24.30°, and 25.26 ° in its X-ray powder diffraction pattern at reflection angles 2θ (claim 4); the non-solvated crystal C has characteristic peaks at 4.84°, 9.68°, 12.92 °, 14.60°, 16.46°, 17.44°, 22.00°, and 25.28° in its X-ray powder diffraction pattern at reflection angles 2θ (claim 6). Thus, the no-solvated crystal A, B or C reads on the non-solvated crystals of instant claim 30.
Lu teaches the method of making the non-solvated crystals, (see Examples 1-3, [0055] and [0056] of English translation).
Lu teaches that the crystals are stable and suitable for pharmaceutical production and long-term storage ([0060] of English translation) and for treating diseases (claims 12 and 13).
It would have prima facie been obvious to one of ordinarily skilled in the art at the time the invention was filed to use the anti-PD-1 antibody and chiauranib for treating tumor of a subject as taught by Yang, and to substitute chiauranib with the no-solvated crystal of chiauranib taught by Lu in the combination, because the no-solvated crystals do not contain organic solvent; stable and suitable for pharmaceutical use as taught by Lu. One of ordinary skill in the art would have had a reasonable expectation that the non-solvated crystal of chiauranib would be more suitable to be used in the claimed method due to its lower toxicity and have longer storage life, as taught by Lu. The motivation would have been to develop a better and safer combination for cancer treatment.
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 29-32, and 35-37 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 9-18, 20-23, and 26 of copending Application No. 18/840,378 (hereinafter Appl. 378, US 2025/0188164 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claim 1 of Appl. 378 teaches a therapeutic combination comprising chiauranib or a pharmaceutically acceptable salt thereof (e.g., hydrochloride salt) or a crystalline form thereof (e.g., non-solvated crystalline form A, B or C) and at least one (e.g., 1, 2 or 3) anti-CTLA4-anti-PD-1 bispecific antibody. As evidenced by [0201] of specification of Appl. 378 (US 2025/0188164 A1), non-solvated crystalline form A, B, or C read on the instant claim 30. An anti-CTLA-anti-PD-1 bispecific antibody would read on “an immune checkpoint inhibitor” of instant claim 29, a PD-1 inhibitor and a CTLA-4 inhibitor of instant claim 32.
Claim 26 of Appl. 378 teaches s method for treating a tumor, comprising a step of administering to a subject in need an effective amount of the therapeutic combination according to claim 1; preferably, the tumor is selected from one or more of melanoma, renal cancer, prostate cancer, bladder cancer, colon cancer, rectal cancer, gastric cancer, liver cancer, lung cancer, ovarian cancer, leukemia, breast cancer, …, malignant melanoma and ovarian germ cell neoplasm.
Taken together, claims 1 and 26 teaches the instant claims 29, 30, 32, 36, 37.
Regarding instant claim 31, claim 4 of Appl. 378 teaches the chiauranib or the pharmaceutically acceptable salt thereof or the crystalline form thereof is in a unit dose of 0.1 mg-100 mg, 0.5 mg-50 mg, 1 mg-20 mg, 2 mg-15 mg, 3 mg-12 mg, 4 mg-8 mg, or 5 mg, which reads on the range of 1 to 100 mg as instantly claimed.
Regarding claim 35, claim 3 of the Appl. 378 teaches the anti-CTLA4-anti-PD-1 bispecific antibody is in a unit dose of 100 mg-1000 mg, 200 mg-800 mg, 200 mg-500 mg, 300 mg-600 mg, 400 mg-500 mg, or 450 mg, which reads on the range 1-1000 mg of instantly claimed.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 38-40 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 9-18, 20-23, and 26 of copending Application No. 18/840,378 (hereinafter Appl. 378, US 2025/0188164 A1), as applied to claims 29-32 and 35-37, in view of Yang (Yang et al., WO 2019/096194 A1, Publication Date: 05/23/2019, cited in IDS of 03/08/2023).
The claims of Appl. 378 teach the method of instant claim 29 as set forth above. However, the claims of Appl. 378 do not teach the administration method as recited by instant claims 38-40.
Regarding claim 38-39, Yang teaches In a preferred embodiment of the present invention, when administering, the dosage of the PD-1 antibody is 60 to 600 mg, intravenous infusion, once every three weeks; the dosage of the VEGFR inhibitor is 250 mg to 500 mg, orally, once every one to two days ([0040] of English translation on page 7); or in a preferred embodiment of the present invention, when administering, the dosage of the PD-1 antibody is 200 mg, intravenous infusion, once every two weeks; the dosage of the VEGFR inhibitor is 375 mg, orally, once a day ([0043] of English translation on page 7).
Regarding claim 40, as shown above, PD-1 antibody is administered once every two weeks; VEGFR inhibitor is administered once a day, thus, the first component and the second component are administered separately.
It would have prima facie been obvious to one of ordinarily skilled in the art at the time the invention was filed to apply the administration method of Yang for the combination taught by the claims of Appl. 378, because Yang and the claims of Appl. 378 are drawn to the method in the same field (treating cancers) with the same combination (a chiauranib and an immune checkpoint inhibitor). One of ordinary skill would have a reasonable expectation of success with the well-known administration methods for treating cancers, as evidenced by Yang.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHENG LU whose telephone number is (571)272-0334. The examiner can normally be reached Monday-Friday 8-5.
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/CHENG LU/ Examiner, Art Unit 1642