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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. This application is a 371 of PCT/CN2021/079403 filed March 5, 2021.
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in China PCT/CN2020/078158 filed March 6, 2020. The certified copy as required by 37 CFR 1.55 is filed on September 6, 2022 in the instant application. However, support for the claimed invention cannot be determined because the foreign priority document provided is not in English. Therefore, the instant application is not entitled to the benefit of the foreign priority date of March 6, 2020. 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). Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Accordingly, all claims have been given an effective filing date of March 5, 2021.
Election/Restriction
Applicant's election without traverse of Group I (Claims 1, 3-9, and 11) in the reply filed on January 5, 2026 is acknowledged.
Applicant’s species election of:
TRAIL-R2 agonistic antibody
CTB006 antibody
Pancreatic cancer
in the reply filed on January 5, 2026 is acknowledged. Because Applicant did not distinctly and specifically point out the supposed errors in the species election requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 12, 14-21, and 32-33 are withdrawn from further consideration pursuant
to 37 CFR 1.142(b), as being drawn to a nonelected inventions or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on January 5, 2026.
Claim Status
Claim listing filed on September 6, 2022 is pending. Claims 2, 10, 13, 22-31, and 34 are canceled. Claims 3, 6-9, 11, 14, and 17-21 are amended. Claims 12, 14-21, and 32-33 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected species. Claims 1, 3-9, and 11 are examined upon their merits.
Information Disclosure Statement
The information disclosure statement filed on September 6, 2022 fails to comply with 37 CFR 1.98(a)(3)(i) because it does not include a concise explanation of the relevance, as it is presently understood by the individual designated in 37 CFR 1.56(c) most knowledgeable about the content of the information, of each reference listed that is not in the English language. This specifically pertains to foreign patent CN 108472359. The IDS filed on September 6, 2022 has been considered with the exception of the lined-through reference.
All the other information disclosure statements (IDSs) submitted on April 23, 2024 and May 6, 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Specification
The disclosure is objected to because of the following informalities: The title at the top of the specification recites “USE OF CTB006 IN COMBINATION WITH PONATINIB” which is not consistent with the title listed on the Application Data Sheet filed on September 6, 2022 which recites “COMBINED USE OF CTB006 AND PONATINIB.” 37 C.F.R. 1.72 states “Unless the title is supplied in an application data sheet, the title of the invention should appear as a heading on the first page of the specification.” It is unclear which title is the intended title due to the inconsistency between the Application Data Sheet and the specification. Appropriate correction is required.
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.
Claims 5 and 8-9 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 5 recites wherein the TRAIL-R2 agonistic antibody is B273. The specification teaches that the DR5 agonistic monoclonal antibody B273 is manufactured by Daiichi Sankyo (page 21, paragraph 3). However, the anti-DR5 monoclonal antibody produced by Daiichi Sankyo is called “DS 8273,” “DS-8273a,” or “DS8273” as evidenced by the screenshot below from AdisInsight. Examiner cannot find any record of a TRAIL-R2 agonistic antibody produced by Daiichi Sankyo called “B273.” Therefore, it is unclear what is claimed by the antibody “B273.” For the purpose of compact prosecution, “B273” in Claim 5 is interpreted as “DS 8273.”
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Claim 8 recites the limitation "the tumor" in line 2. There is insufficient antecedent basis for this limitation in the claim, because no tumor is defined in Claim 1. The limitations of Claim 8 are indefinite.
Claim 9 recites the limitation "the tumor" in line 2. There is insufficient antecedent basis for this limitation in the claim, because no tumor is defined in Claim 1. The limitations of Claim 9 are indefinite.
Note, the specification defines “apoptosis inducer” as various chemical agents (e.g. small molecule drugs), biological agents (e.g. polypeptides or antibodies), or physical treatments (e.g. radiation) that promote apoptosis of cells in vitro or in vivo (page 5, paragraph 12). The broadest reasonable interpretation of this definition is that “apoptosis inducer” encompasses any agent known in the art prior to filing that induces apoptosis directly (e.g. cyclophosphamide) or indirectly (e.g. anti-PD-L1 antibodies).
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 1, 3-9, and 11 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 claims contain 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.
Claim 1 is directed to a combination of antitumor medicaments comprising an apoptosis inducer and a multi-targeted kinase inhibitor. “Apoptosis inducer” broadly encompasses thousands of possible agents such as cisplatin, carboplatin, oxaliplatin, paclitaxel, docetaxel, cyclophosphamide, 5-fluorouracil, gemcitabine, pembrolizumab, nivolumab, atezolizumab, durvalumab, ipilimumab, rituximab, trastuzumab, cetuximab, radiation, etc. Similarly, antitumor multi-targeted kinase inhibitors encompass hundreds of possible agents such as sunitinib, pazopanib, cabozantinib, axitinib, sorafenib, imatinib, dasatinib, nilotinib, ponatinib, lenvatinib, vandetanib, etc. Therefore, the instant claims are directed to a genus of possible antitumor medicament combinations with substantial variation in structure and function. Claim 5 defines specific apoptosis inducers but does not further define the multi-targeted kinase inhibitor. Claims 6-7 define a specific multi-targeted kinase inhibitor but do not further define the apoptosis inducer.
In making a determination of whether the application complies with the written description requirement of 35 U.S.C. 112, first paragraph, it is necessary to understand what Applicant has possession of and what Applicant is claiming. In order to provide adequate written description and evidence of possession of this claimed genus of antitumor medicaments, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof.
In the instant case, the specification evaluates one multi-targeted kinase inhibitor (ponatinib) in combination with six apoptosis inducers (TRAIL ligand, CTB006 antibody, CTB003 antibody, conatumumab, hexabody-DR5/DR5, and DS 8273) (Examples 1-3). All of the evaluated apoptosis inducers are TRAIL-R2 agonists.
A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014) (MPEP § 2163.05.Ib). Because only one multi-targeted kinase inhibitor (ponatinib) was evaluated in combination with only one class of apoptosis inducer (TRAIL-R2 agonists), the specification does not provide adequate written description of the claimed genus. No guidance is provided for the structural and functional characteristics of other antitumor medicament combinations comprising agents with alternative targets and mechanisms of action. In view of the case law directed to an appropriate number of representative species, claims 1, 3-9, and 11 are rejected for insufficient written description.
Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. § 112 is severable from its enablement provision (see page 1115).
Claims 1, 3-9, and 11 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for antitumor medicament combinations comprising a TRAIL-R2 agonist and ponatinib (or other generations of BCR-ABL inhibitors thereof), does not reasonably provide enablement for the genus of antitumor medicament combinations comprising any type of apoptosis inducer and any type of multi-targeted kinase inhibitor. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
MPEP § 2164.01(a) states that there are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure
does not satisfy the enablement requirement and whether any necessary experimentation is “undue”. These factors include, but are not limited to:
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.
In re Wands, 8 USPQ2d, 1400 (CAFC 1988) and MPEP 2164.01.
The breadth of the claims and nature of the invention:
The nature of the invention is complex. As understood with the broadest reasonable interpretation, the claims are directed to a combination of antitumor medicaments comprising any type of apoptosis inducer and any type of multi-targeted kinase inhibitor. Claim 5 defines specific apoptosis inducers but does not further define the multi-targeted kinase inhibitor. Claims 6-7 define a specific multi-targeted kinase inhibitor but do not further define the apoptosis inducer. Therefore, the instant claims are directed to a genus of possible antitumor medicament combinations with substantial variation in structure and function.
When analyzing the scope of enablement, the claims are analyzed with respect to the teachings of the specification and are to be "given their broadest reasonable interpretation consistent with the specification." See MPEP 2111 [R-5]; Phillips v. AWH Corp., 415 F.3d 1303, 75 USPQ2d 1321 (Fed. Cir. 2005); and In re Hyatt, 211 F.3d 1367, 1372, 54 USPQ2d 1664, 1667 (Fed. Cir. 2000). Applicant always has the opportunity to amend the claims during prosecution, and broad interpretation by the examiner reduces the possibility that the claim, once issued, will be interpreted more broadly than is justified. In re Prater, 415 F.2d 1393, 1404-05, 162 USPQ 541, 550- 51 (CCPA 1969).
Amount of direction provided by inventor and the existence of working examples:
The specification evaluates one multi-targeted kinase inhibitor (ponatinib) in combination with six apoptosis inducers (TRAIL ligand, CTB006 antibody, CTB003 antibody, conatumumab, hexabody-DR5/DR5, and DS 8273) (Examples 1-3). All of the evaluated apoptosis inducers are TRAIL-R2 agonists.
One species of multi-targeted kinase inhibitor in combination with one class of apoptosis inducer (TRAIL-R2 agonist) does not adequately represent the scope of antitumor medicament combinations claimed that encompasses thousands of structurally and functionally distinct combinations. A person having ordinary skill in the art would have to make a substantial inventive contribution in order to make and characterize a representative number of antitumor medicament combinations to encompass the claimed genus.
The state of the prior art and level of predictability in the art:
The level of predictability in the art depends, most importantly, on whether the claimed invention can be practiced by one of ordinary skill in the art. Price et al. OncoTargets and Therapy 2013 teaches that ponatinib is a third-generation tyrosine kinase inhibitor (TKI) that can inhibit T315I mutant BCR-ABL (introduction paragraph 1; page 1113 paragraph 1; abstract). Imatinib is the first-generation BCR-ABL TKI (introduction paragraph 1), and dasatinib and nilotinib are second-generation BCR-ABL TKIs (introduction paragraph 1). Therefore, the specification and the state of the art prior to filing provide enablement for a multi-targeted kinase inhibitor comprising ponatinib, imatinib, dasatinib, or nilotinib. One of ordinary skill would understand that the function of ponatinib reasonably represents the function of imatinib, dasatinib, and nilotinib as they are all known species of BCR-ABL TKIs.
The state of the art prior to filing does not provide enabling guidance for combining any type of apoptosis inducer with any type of multi-targeted kinase inhibitor that can have different structures, targets, and mechanisms of action. There is no support in the Applicant’s disclosure leading one of ordinary skill to overcome the lack of predictability in the genus of antitumor medicament combinations claimed.
Level of skill in the art:
The level of skill would be high encompassing chemotherapies, immunotherapies, small molecule inhibitors, in vitro and in vivo drug combination assays, etc.
The quantity of experimentation needed to make or use the invention based on the content of the disclosure:
In light of the unpredictability surrounding the claimed subject matter, the undue breadth of the claimed invention’s intended use, and the lack of adequate guidance, one wishing to make and practice the presently claimed invention would be unable to do so without engaging in undue experimentation. A person having ordinary skill in the art would have to perform further experimentation to combine a representative number of apoptosis inducers and multi-targeted kinase inhibitors and screen the combinations’ characteristics in order to practice the invention commensurate with the scope of the claims.
The instant specification does not enable the invention to make and use the entire genus of antitumor medicament combinations; therefore, Claims 1, 3-9, and 11 are rejected.
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 1, 3-4, and 8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hamai et al. Oncogene 2006.
In regard to Claims 1 and 3-4, Hamai teaches that imatinib (a multi-targeted kinase inhibitor that inhibits kinases such as c-ABL, platelet derived growth factor receptors (PDGFRs), and c-kit) enhances TRAIL-mediated apoptosis in melanoma cells (page 7619 paragraph 5; page 7625 paragraph 2). Concomitant treatment with TRAIL and imatinib increased TRAIL-induced apoptosis to a greater extent as compared to either agent used individually (page 7627 paragraph 1). Note, “TRAIL” refers to recombinant human soluble TRAIL ligand (page 7631 paragraph 5). Hamai concludes that imatinib in combination with TRAIL could be administered as a new approach to treat melanoma (page 7631 paragraph 4).
In regard to Claim 8, the melanoma tumor cells expressed TRAIL-R2 on the cell surface (page 7620 paragraph 1 and Fig. 1b).
Therefore, Claims 1, 3-4, and 8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hamai.
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.
Claims 1, 3-5, and 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Hamai et al. Oncogene 2006 in view of Yu et al. WO 2007/128231.
The teachings of Hamai as they apply to Claims 1, 3-4, and 8 are outlined in the 102(a)(1) rejection above. Hamai fails to teach wherein the TRAIL-R2 agonist is the TRAIL-R2 agonistic antibody CTB006 (Claim 5) or wherein the tumor is pancreatic cancer (Claim 9).
Yu teaches that therapeutically administering TRAIL ligand has several disadvantages such as poor tumor cell selectivity and short in vivo half-life which limits the effective dose and anti-cancer efficacy of TRAIL ligand in vivo (page 2 lines 13-19). These limitations of TRAIL ligand can be overcome by administering monoclonal antibodies that selectively target and activate the death receptors of TRAIL (page 2 lines 20-33). Yu specifically teaches the TRAIL-R2 agonistic antibody CTB006 (Example 2 pages 74-76). The TRAIL-R2 agonistic antibodies have anti-tumor efficacy in pancreatic cancer cell lines (Fig. 27 and caption).
Based on these teachings, it would have been prima facie obvious to one of ordinary skill in the art, at the time the invention was made, to substitute the TRAIL ligand taught by Hamai with the TRAIL-R2 agonistic antibody CTB006 taught by Yu. Yu teaches that the motivation to administer TRAIL-R2 agonistic antibodies instead of TRAIL ligands is to improve in vivo half-life and tumor cell targeting. One of ordinary skill would understand that both the TRAIL ligand and the TRAIL-R2 agonistic antibody bind to TRAIL-R2 and activate the cell death pathway. Because the two agents have the same anti-tumor mechanism of action, the results of the substitution would have been predictable.
Claims 1, 3-4, and 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Hamai et al. Oncogene 2006 in view of Price et al. OncoTargets and Therapy 2013.
The teachings of Hamai as they apply to Claims 1, 3-4, and 8 are outlined in the 102(a)(1) rejection above. Hamai fails to teach wherein the multi-targeted kinase inhibitor is ponatinib (Claim 6) or ponatinib hydrochloride (Claim 7).
Price teaches that imatinib was the first commercially available tyrosine kinase inhibitor (TKI) and revolutionized the treatment of leukemia by targeting the BCR-ABL protein which is responsible for many of the pathologic processes of leukemia (introduction paragraph 1). More potent second-generation TKIs, such as dasatinib and nilotinib, were developed to improve upon those responses observed with imatinib by inhibiting BCR-ABL in addition to other oncogenic kinases such as Src family kinases, c-Kit, and PDGFR (introduction paragraph 1). Ponatinib is a third-generation TKI that can inhibit T315I mutant BCR-ABL and consequently overcomes the observed resistance to earlier TKIs (introduction paragraph 1; page 1113 paragraph 1; abstract). Ponatinib is formulated as ponatinib hydrochloride for oral administration (page 1113 paragraph 3).
Based on these teachings, it would have been prima facie obvious to one of ordinary skill in the art, at the time the invention was made, to substitute the imatinib taught by Hamai with ponatinib taught by Price. It is clear from Price that ponatinib is a newer version (third-generation) of imatinib, and they both inhibit BCR-ABL in addition to other kinases. The motivation to use ponatinib instead of imatinib is in scenarios where patients are resistant to imatinib, specifically because ponatinib can inhibit T315I mutant BCR-ABL whereas imatinib cannot. One of ordinary skill would understand that substituting a newer generation TKI for an older generation TKI with the same mechanism of action would yield predictable results.
Claims 1, 3-9, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Hamai et al. Oncogene 2006 in view of Yu et al. WO 2007/128231 and Price et al. OncoTargets and Therapy 2013.
The teachings of Hamai as they apply to Claims 1, 3-4, and 8 are outlined in the 102(a)(1) rejection above. The teachings of Hamai in view of Yu as they apply to Claims 1, 3-5, and 8-9 are outlined in the 103 rejection above and make obvious a combination of antitumor medicaments comprising a TRAIL-R2 agonist antibody and the multi-targeted kinase inhibitor imatinib. The teachings of Hamai in view of Price as they apply to Claims 1, 3-4, and 6-8 are outlined in the 103 rejection above and make obvious a combination of antitumor medicaments comprising a TRAIL ligand and the multi-targeted kinase inhibitor ponatinib. The rejections of record fail to teach wherein the apoptosis inducer is in dosage form suitable for intravenous administration and the multi-targeted kinase inhibitor is in a dosage form suitable for oral administration (Claim 11).
Yu teaches that intramuscular injection or intravenous infusion are preferred for administration of the anti-TRAIL receptor antibody (page 52 lines 18-27).
Price teaches that ponatinib is orally administered (page 1112 paragraph 6).
Based on these teachings, it would have been prima facie obvious to one of ordinary skill in the art, at the time the invention was made, to formulate the TRAIL-R2 agonist antibody for intravenous administration as taught by Yu and to formulate the ponatinib for oral administration as taught Price. The teachings of Hamai as outlined above make obvious combining the apoptosis inducer (TRAIL-R2 agonist) and multi-targeted kinase inhibitor (imatinib/ponatinib) into a combination of antitumor medicaments. One of ordinary skill would be motivated to formulate the TRAIL-R2 agonist for intravenous administration and the imatinib/ponatinib for oral administration because Yu and Price teach that these modes of administration are preferred and/or standard in the art, respectively.
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.
1. Claims 1 and 9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 13, and 17 of copending U.S. App. No. 19/209,557.
The instant claims recite a combination of antitumor medicaments comprising an apoptosis inducer and a multi-targeted kinase inhibitor (Claim 1), and the tumor is lung cancer (Claim 9). Note, the broadest reasonable interpretation of “apoptosis inducer” based on the specification definition (page 5, paragraph 12) encompasses any agent known in the art prior to filing that induces apoptosis directly (e.g. cyclophosphamide) or indirectly (e.g. anti-PD-L1 antibodies).
The copending claims are directed to a combination of antitumor medicaments comprising an immunotherapeutic agent and AL3818 (Claim 1). The immunotherapeutic agent can be an anti-PD-1 or anti-PD-L1 antibody (Claim 17). Note, AL3818 is defined as a multi-target receptor tyrosine kinase inhibitor (copending specification paragraph [0007]). The tumor is lung cancer (Claim 13).
Because the copending claims recite the same elements of the instant claims, the instant claims are either anticipated and/or rendered obvious by the copending claims. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
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/SARAH COOPER PATTERSON/Examiner, Art Unit 1675
/STACEY N MACFARLANE/Examiner, Art Unit 1675