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 with traverse of Group I, claim 19 and species of claims 2-11 in the reply filed on October 17, 2025 is acknowledged.
Applicants traversed the restriction on the ground that the inventions as identified by the office are sufficient related, and can be examined without serious burden on the office. The traversal is not found to be persuasive because the inventions have acquired a separate status in the art in view of their different classification, the inventions require a different field of search, such as under 35 U.S.C. 112, first paragraph. In addition, the claims encompasses a large number of species, such as different variants of Matrix proteins, different tumor and/or cancers, different checkpoint inhibitors, and different cancers/tumors which requires a different field of search or electronic resources, or employing different search strategy or search queries. The search would be a burden on the office. Thus the requirement is still deemed proper and is therefore made FINAL.
It is noted that applicant was required to elect a specific mutation combination, a specific antigen and a specific checkpoint inhibitor (see Office Action of 09/11/2025). Applicant did not elect a single specific species according the election of species requirements set forth in the Office Action of 09/11/2025. In an effort to expedite prosecution, all claims in Group I (claims 1-19) are included in examination.
Claims 1-20 are pending.
Claims 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions or species, there being no allowable generic or linking claim.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 1-19 are pending and under consideration.
Priority
It is acknowledged that this application is a continuation application of PCT application No. PCT/CN2021/093143, filed on May 11, 2021, which claims priority to China patent application No. 202010394775.7, filed on May 12, 2020. The priority date of May 12, 2020 has been established for the pending claims.
Information Disclosure Statement
The Information Disclosure Statements (IDS) filed on 11/11/2022 and 08/19/2025 have been considered and entered by examiner.
It is noted that the English translations for the two Foreign Patent Documents in IDS of 11/11/2022 were not provided as indicated in the IDS.
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 1-19 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.
Claim 1 recites a virus strain with a matrix protein M "subjected" to an engineering. The metes-and-bounds of the claims are unclear because, a reading the instant specification indicates applicant may be intending to claim a virus strain with an modified matrix protein M, the plain meaning of the claims leads to an interpretation that the claims are directed to a virus strain with a matrix protein M that is intended to be "subjected" (subjected means: "to cause or force to undergo or endure") to recited engineering. It is unclear whether the claims are directed to a virus strain with an engineered M protein or to a virus strain that has yet to be "subjected" ("to cause or force to undergo or endure") to recited engineering.
Claim 1 recites “position 111 of an amino acid sequence of the matrix protein M”. The indication of a sequence position without the indication of a SEQ ID NO as reference is vague and unclear. Given Broadest Reasonable Interpretation, the claim encompass different matrix protein M (e.g. wild-type or modified protein M) which can comprise variants with different lengths. The specification uses SEQ ID NO: 2 (unengineered wild-type sequence of matrix protein M) as the reference.
Claims 2-10 also recite “position xxx” of the amino acid sequence of the matrix protein. As set forth above, these claims are indefinite.
Claim 11 recites “using the pharmaceutical composition according to claim 1”, but, since the claim does not set forth any steps involved in the method/process applicant is intending to encompass. A claim is indefinite where it merely recites a use without any active, positive steps delimiting how this use is actually practiced.
Claims 12-19 are also rejected because these claims depend on claim 1 directly or indirectly.
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 1-10 and 12-19 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.
The claims are drawn to a pharmaceutical composition, comprising an attenuated oncolytic virus strain with a matrix protein M with amino acids at positions recited by the instant claims (leucine at position 111, methionine at position 51, etc...) subjected to an engineering and an immune checkpoint inhibitor. Given Broadest Reasonable Interpretation (BRI), the claims encompass a broad genus of matrix protein M (including variants of protein M, or protein M with additional mutations) subjected to an engineering. However, the written description in this case only set forth SEQ ID NO: 2 as an example of matrix protein M with amino acids positions recited by the instant claims subjected to an engineering, for example SEQ ID NOs: 4, and 7-11. Based on the Sequence-Listing, compared to SEQ ID NO: 2, SEQ NO: 4 comprises M51R/ΔL111/V221F/S226R; SEQ NO: 7 comprises ΔL111; SEQ NO: 8 comprises M51R/ΔL111; SEQ NO: 9 comprises ΔL111/V221F; SEQ NO: 10 comprises ΔL111/ S226/R; SEQ NO: 11 comprises ΔL111/V221F/S226R. The specification teaches that these variants have desired properties for a pharmaceutical composition (see Examples 2-8).
Thus, it is acknowledged that the specification has sufficient written description for an attenuated oncolytic virus strain, wherein the attenuated oncolytic virus strain is aa vesicular stomatitis virus (VSV) MuddSummer subtype strain with a modified matrix protein and wherein the modified matrix protein M comprises an amino acid sequence selected from the group consisting of SEQ ID NO: 4, SEQ ID NO: 7, SEQ ID NO: 8, SEQ ID NO: 9, SEQ ID NO: 10 and SEQ ID NO: 11. The specification does not disclose, and the art does not teach, the genus of matrix protein M with amino acids at positions recited by the instant claims as broadly encompassed in the claims.
A description of a genus may be achieved by means of a recitation of a representative number of species falling within the scope of the genus or by describing structural features common to that genus that "constitute a substantial portion of the genus." See University of California v. Eli Lilly and Co., 119 F.3d 1559, 1568, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997): "A description of a genus of cDNAs may be achieved by means of a recitation of a representative number of cDNA, defined by nucleotide sequence, falling within the scope of the genus or of a recitation of structural features common to the members of the genus, which features constitute a substantial portion of the genus."
The instant specification fails to provide sufficient descriptive information, such as definitive structural features that are common to the genus. That is, the specification provides neither a representative number that encompass the genus nor does it provide a description of structural features that are common to the genus so that one of skill in the art can 'visualize or recognize' the members of the genus. "[A] sufficient description of a genus ... requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can 'visualize or recognize' the members of the genus." Ariad, 598 F.3d at 1350 (quoting Eli Lilly, 119 F.3d at 1568-69). A "representative number of species" means that those species that are adequately described are representative of the entire genus. AbbVie Deutsch/and GMBH v. Janssen Biotech, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014) ("The '128 and' 485 patents, however, only describe species of structurally similar antibodies that were derived from Joe-9. Although the number of the described species appears high quantitatively, the described species are all of the similar type and do not qualitatively represent other types of antibodies encompassed by the 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 to provide a "representative number'' of species.
Since the disclosure fails to describe common attributes or characteristics that adequately identify members of the genus, and because the genus is highly variant, the disclosure of SEQ ID NO:2 is insufficient to describe the genus. Thus, one of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to describe the genus as broadly claimed.
Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111, clearly states "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. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed." (See page 1117.) The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." (See Vas-Cath at page 1116). As discussed above, even though Applicant may propose methods of screening for possible members of the genus, the skilled artisan cannot envision the detailed chemical structure of the encompassed genus, and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolation. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. See Ariad, 94 USPQ2d at 1161; Centocor at 1876 ("The fact that a fully-human antibody could be made does not suffice to show that the inventors of the '775 patent possessed such an antibody.")
Taken together, the specification fails to provide sufficient written description support for the rejected claims.
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.
Claims 1-10, and 12-19 are rejected under 35 U.S.C. 103 as being unpatentable over Lichty (Lichty et al., US 2019/0022203 A1, Publication Date: 01/2//4/2019) in view of Qin (Qin et al., WO 2019/184459 A1, recited by IDS of 11/11/2022, a google translated version is attached in this office action).
Lichty teaches that vesicular stomatitis virus (VSV) engineered to express a tumor antigen can be used as an oncolytic viral immunotherapy. The antitumoral efficacy of the engineered VSV can be enhanced by first administering the tumor antigen prior to the engineered VSV to prime antitumoral immunity and to boost the existing antitumoral immunity ([0004], claim 17).
Lichty teaches a pharmaceutical combination for use in the treatment of cancer or for use in the manufacture of a medicament for treating cancer in a mammal wherein the combination comprises an oncolytic virus and a checkpoint inhibitor. In some embodiments, the pharmaceutical combination comprises a human or humanized monoclonal antibody against CTLA4 or PD-1/PD-L1 and a modified VSV ([0020]). Lichty teaches various checkpoint inhibitors (claims 3-7).
Lichty teaches modification in protein M (such as L123W) that renders the virus active in cancer cells yet attenuated in normal cells ([0063]).
Lichty teaches various tumor antigens, including NYESO1 ([0074]), MAGEA3 ([0070]),
Lichty teaches that combination of oncolytic Rhabdovirus (MG1/GFP) + checkpoint inhibitor (CTLA4 antibody) led to an increased anti-tumor activity (Example 1, [0111]). MG1/GFP comprise a L123W mutation in protein M ([0109]).
Lichty teaches combination of anti-PD1 antibody + oncolytic Rhabdovirus (MG1 hDCT) with prime boost by Ad-hDCT (Example 2).
Lichty teaches that addition of anti-PD1 antibody enhances the DCT boost and leads to a profound increase in survival when compared to prime/boost or anti-PD1 treatment alone ([0125], and Fig.15).
Lichty teaches that virus treatment leads to an increase in PD-L1 expression (Example 4, [0143]).
Lichty teaches clinical trial with combination of oncolytic virus vaccine plus checkpoint inhibitor (Example 5). Virus (MG1MA3) is administered on day 1 and day 4 (boost) and the checkpoint inhibitor (pembrolizumab) is first administered on day -13, (day -13 is prior to day 4). Claim 10 teaches that the first administration of checkpoint inhibitor is prior to the first administration of oncolytic virus.
Lichty teaches as set forth above. However, Lichty does not teach attenuated oncolytic virus comprising a protein M with the specific modification recited by the instant claims, or specific subtype MuddSummer.
Qin teaches a modified matrix protein (M) wherein the recombinant oncolytic baculovirus is preferably vesicular Stomatitis virus MuddSummer strain (page 8, para. 3).
Qin teaches that “RV-gp33 vector is a recombinant VSV MuddSummer subtype, which expresses dominant CD8+ and CD4+ T cell epitopes of lymphocytic choriomeningtis virus glycoprotein. … In one embodiment, the modified matrix protein (M) of the recombinant vesicular stomatitis virus MuddSummer subtype strain is selected from the 51st position, the 221 position, and the 226 position and has an amino acid substitution: the 51th methionine M was replaced by arginine R, the 221th valine V was replaced by phenyalanine F, and the 226th glycine G was replaced by R. In another embodiment, the modified matrix protein (M) of the recombinant vesicular stomatitis virus MuddSummer subtype strain is selected from the 21st position, the 51st position, the 111th position, and the 221st position, and has an amino acid substitution. The amino acid substitution method is: the 21th glycine G is replaced by glutamic acid E, the 51st methionine M is replaced by alanine A, the 111th leucine L is replaced by phenylalanine F, the 221st position. Proline V was replaced with phenylalanine F. It is noted, given Broadest Reasonable Interpretation, the 111th leucine L is replaced by phenylalanine F would read on the limitation “knocking out of leucine-encoding bases at position 111” (see page 27, under § virus), because the leucine-encoding base does not exist in the L111F mutated version.
Qin teaches oncolytic virus expresses a tumor antigen (page 21, under § Oncolytic virus vaccine).
Qin teaches the amino acid sequence of the original matrix protein (M) of the oncolytic baculovirus MuddSummer strain, and various mutated versions (page 23, § Sequence table meaning).
Qin teaches that different attenuated RV-Mut strains including RV-GFP-M51R/V221F/G226R, RV-GFP-G21E/M51A/L111F/V221F are generated (Example 2, pages 29-30).
Qin teaches that attenuated RV-Mut strains has the improved therapeutic activity (Table 1, Fig. 7).
Taken together, Qin teaches various attenuated oncolytic baculovirus MuddSummer strain and all the mutations in the instantly claimed positions and the replaced amino acids at each position.
It would have prima facie been obvious to one of ordinarily skilled in the art at the time the invention was filed to modified the combination taught by Lichty by substituting the oncolytic virus with an attenuated oncolytic baculovirus MuddSummer taught by Qin and to combine different mutations (such as the 51st position replaced by R, the 111th position replaced by F, the 221st position replaced by F and the 226th position replaced by R) in different combinations taught by Qin to develop a strain with best therapeutic properties for oncolytic virus vaccine. Given that the oncolytic baculovirus MuddSummer subtype is well known in the art and the generate mutations in protein M is routine in the art, as evidenced by Qin, one of ordinary skill in the art would have reasonable expectation that the attenuated oncolytic virus with the mutation combinations would improved the efficacy of the combination because Qin shows various mutated virus versions have improved therapeutic activities. The motivation would have been to develop a better combination for oncolytic virus vaccine.
Regarding claims 12-15, Lichty teaches that vesicular stomatitis virus (VSV) engineered to express a tumor antigen can be used as an oncolytic viral immunotherapy ([0004], claim 17). Lichty teaches clinical trial with combination of oncolytic virus vaccine (MG1MA3) plus checkpoint inhibitor (Examples 4 and 5). Virus MG1MA3 comprises a MAGE-A3 ([0140]). Qin also teaches oncolytic virus expresses a tumor antigen (page 21, under § Oncolytic virus vaccine), and various tumor antigens such as NYESO-1, MAGE proteins (page 22, under § Tumor antigen).
Regarding claim 16, Lichty teaches a pharmaceutical combination for use in the treatment of cancer or for use in the manufacture of a medicament for treating cancer in a mammal wherein the combination comprises an oncolytic virus and a checkpoint inhibitor. In some embodiments, the pharmaceutical combination comprises a human or humanized monoclonal antibody against CTLA4 or PD-1/PD-L1 and a modified VSV ([0020]). Lichty teaches various checkpoint inhibitors (claims 3-7).
Regarding claim 17, Lichty teaches that anti-PD1 antibody is administered prior to the administration of oncolytic virus (Table 2 on page 12). In addition, the method of using a product does not change the structure of a product.
Regarding claim 18 and 19, Lichty teaches that the combination can be used to treat various cancers including head and neck cancer, breast cancer, melanoma, etc ([0016]).
Further, it is noted the instant claims are peculiarly drawn to a virus strain with a matrix protein M "subjected" to an engineering (see above rejection under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph). The plain meaning of "subjected" is: to cause or force to undergo or endure. Therefore, it appears the claims are also directed to an attenuated oncolytic vesicular stomatitis virus (VSV) MuddSummer strain of Qin et al that has yet to be subjected to ("to cause or force to undergo or endure") recited engineering.
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.
U.S. Patent No. 12,496, 337
Claims 1-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 12,496, 337 B2 (hereinafter Pat. 337) in view of Lichty (Lichty et al., US 2019/0022203 A1, Publication Date: 01/2//4/2019).
Regarding instant claims 1-11, the claims of Pay. 337 teaches: an attenuated oncolytic virus strain, wherein the attenuated oncolytic virus strain is a vesicular stomatitis virus (VSV) MuddSummer subtype strain with a modified matrix protein M, and wherein the modified matrix protein M comprises an amino acid sequence selected from the group consisting of SEQ ID NO: 4, SEQ ID NO: 7, SEQ ID NO: 8, SEQ ID NO: 9, SEQ ID NO: 10 and SEQ ID NO: 11 (claim 1). As shown below, SEQ ID NO: 4, 7-11 of Pat. 337 are identical to SEQ ID NO: 4, 7-11, respectively.
SEQ ID NO: 4 alignment:
Query Match 100.0%; Score 1221; Length 228;
Best Local Similarity 100.0%;
Matches 228; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MSSLKKILGLKGKGKKSKKLGIAPPPYEEDTSMEYAPSAPIDKSYFGVDERDTYDPNQLR 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MSSLKKILGLKGKGKKSKKLGIAPPPYEEDTSMEYAPSAPIDKSYFGVDERDTYDPNQLR 60
Qy 61 YEKFFFTVKMTVRSNRPFRTYSDVAAAVSHWDHMYIGMAGKRPFYKILAFGSSNLKATPA 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 YEKFFFTVKMTVRSNRPFRTYSDVAAAVSHWDHMYIGMAGKRPFYKILAFGSSNLKATPA 120
Qy 121 VLADQGQPEYHAHCEGRAYLPHRMGKTPPMLNVPEHFRRPFNIGLYKGTIELTMTIYDDE 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 VLADQGQPEYHAHCEGRAYLPHRMGKTPPMLNVPEHFRRPFNIGLYKGTIELTMTIYDDE 180
Qy 181 SLEAAPMIWDHFNSSKFSDFREKALMFGLIVEKKASGAWFLDSIRHFK 228
||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 SLEAAPMIWDHFNSSKFSDFREKALMFGLIVEKKASGAWFLDSIRHFK 228
SEQ ID NO: 7 alignment:
Query Match 100.0%; Score 1218; Length 228;
Best Local Similarity 100.0%;
Matches 228; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MSSLKKILGLKGKGKKSKKLGIAPPPYEEDTSMEYAPSAPIDKSYFGVDEMDTYDPNQLR 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MSSLKKILGLKGKGKKSKKLGIAPPPYEEDTSMEYAPSAPIDKSYFGVDEMDTYDPNQLR 60
Qy 61 YEKFFFTVKMTVRSNRPFRTYSDVAAAVSHWDHMYIGMAGKRPFYKILAFGSSNLKATPA 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 YEKFFFTVKMTVRSNRPFRTYSDVAAAVSHWDHMYIGMAGKRPFYKILAFGSSNLKATPA 120
Qy 121 VLADQGQPEYHAHCEGRAYLPHRMGKTPPMLNVPEHFRRPFNIGLYKGTIELTMTIYDDE 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 VLADQGQPEYHAHCEGRAYLPHRMGKTPPMLNVPEHFRRPFNIGLYKGTIELTMTIYDDE 180
Qy 181 SLEAAPMIWDHFNSSKFSDFREKALMFGLIVEKKASGAWVLDSISHFK 228
||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 SLEAAPMIWDHFNSSKFSDFREKALMFGLIVEKKASGAWVLDSISHFK 228
SEQ ID NO: 8 alignment:
Query Match 100.0%; Score 1218; Length 228;
Best Local Similarity 100.0%;
Matches 228; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MSSLKKILGLKGKGKKSKKLGIAPPPYEEDTSMEYAPSAPIDKSYFGVDERDTYDPNQLR 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MSSLKKILGLKGKGKKSKKLGIAPPPYEEDTSMEYAPSAPIDKSYFGVDERDTYDPNQLR 60
Qy 61 YEKFFFTVKMTVRSNRPFRTYSDVAAAVSHWDHMYIGMAGKRPFYKILAFGSSNLKATPA 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 YEKFFFTVKMTVRSNRPFRTYSDVAAAVSHWDHMYIGMAGKRPFYKILAFGSSNLKATPA 120
Qy 121 VLADQGQPEYHAHCEGRAYLPHRMGKTPPMLNVPEHFRRPFNIGLYKGTIELTMTIYDDE 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 VLADQGQPEYHAHCEGRAYLPHRMGKTPPMLNVPEHFRRPFNIGLYKGTIELTMTIYDDE 180
Qy 181 SLEAAPMIWDHFNSSKFSDFREKALMFGLIVEKKASGAWVLDSISHFK 228
||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 SLEAAPMIWDHFNSSKFSDFREKALMFGLIVEKKASGAWVLDSISHFK 228
SEQ ID NO: 9 alignment:
Query Match 100.0%; Score 1220; Length 228;
Best Local Similarity 100.0%;
Matches 228; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MSSLKKILGLKGKGKKSKKLGIAPPPYEEDTSMEYAPSAPIDKSYFGVDEMDTYDPNQLR 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MSSLKKILGLKGKGKKSKKLGIAPPPYEEDTSMEYAPSAPIDKSYFGVDEMDTYDPNQLR 60
Qy 61 YEKFFFTVKMTVRSNRPFRTYSDVAAAVSHWDHMYIGMAGKRPFYKILAFGSSNLKATPA 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 YEKFFFTVKMTVRSNRPFRTYSDVAAAVSHWDHMYIGMAGKRPFYKILAFGSSNLKATPA 120
Qy 121 VLADQGQPEYHAHCEGRAYLPHRMGKTPPMLNVPEHFRRPFNIGLYKGTIELTMTIYDDE 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 VLADQGQPEYHAHCEGRAYLPHRMGKTPPMLNVPEHFRRPFNIGLYKGTIELTMTIYDDE 180
Qy 181 SLEAAPMIWDHFNSSKFSDFREKALMFGLIVEKKASGAWFLDSISHFK 228
||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 SLEAAPMIWDHFNSSKFSDFREKALMFGLIVEKKASGAWFLDSISHFK 228
SEQ ID NO: 10 alignment:
Query Match 100.0%; Score 1219; Length 228;
Best Local Similarity 100.0%;
Matches 228; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MSSLKKILGLKGKGKKSKKLGIAPPPYEEDTSMEYAPSAPIDKSYFGVDEMDTYDPNQLR 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MSSLKKILGLKGKGKKSKKLGIAPPPYEEDTSMEYAPSAPIDKSYFGVDEMDTYDPNQLR 60
Qy 61 YEKFFFTVKMTVRSNRPFRTYSDVAAAVSHWDHMYIGMAGKRPFYKILAFGSSNLKATPA 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 YEKFFFTVKMTVRSNRPFRTYSDVAAAVSHWDHMYIGMAGKRPFYKILAFGSSNLKATPA 120
Qy 121 VLADQGQPEYHAHCEGRAYLPHRMGKTPPMLNVPEHFRRPFNIGLYKGTIELTMTIYDDE 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 VLADQGQPEYHAHCEGRAYLPHRMGKTPPMLNVPEHFRRPFNIGLYKGTIELTMTIYDDE 180
Qy 181 SLEAAPMIWDHFNSSKFSDFREKALMFGLIVEKKASGAWVLDSIRHFK 228
||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 SLEAAPMIWDHFNSSKFSDFREKALMFGLIVEKKASGAWVLDSIRHFK 228
SEQ ID NO: 11 alignment:
Query Match 100.0%; Score 1221; Length 228;
Best Local Similarity 100.0%;
Matches 228; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MSSLKKILGLKGKGKKSKKLGIAPPPYEEDTSMEYAPSAPIDKSYFGVDEMDTYDPNQLR 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MSSLKKILGLKGKGKKSKKLGIAPPPYEEDTSMEYAPSAPIDKSYFGVDEMDTYDPNQLR 60
Qy 61 YEKFFFTVKMTVRSNRPFRTYSDVAAAVSHWDHMYIGMAGKRPFYKILAFGSSNLKATPA 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 YEKFFFTVKMTVRSNRPFRTYSDVAAAVSHWDHMYIGMAGKRPFYKILAFGSSNLKATPA 120
Qy 121 VLADQGQPEYHAHCEGRAYLPHRMGKTPPMLNVPEHFRRPFNIGLYKGTIELTMTIYDDE 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 VLADQGQPEYHAHCEGRAYLPHRMGKTPPMLNVPEHFRRPFNIGLYKGTIELTMTIYDDE 180
Qy 181 SLEAAPMIWDHFNSSKFSDFREKALMFGLIVEKKASGAWFLDSIRHFK 228
||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 SLEAAPMIWDHFNSSKFSDFREKALMFGLIVEKKASGAWFLDSIRHFK 228
Based on the Sequence-Listing, compared to SEQ ID NO: 2, SEQ NO: 4 comprises M51R/ΔL111/V221F/S226R; SEQ NO: 7 comprises ΔL111; SEQ NO: 8 comprises M51R/ΔL111; SEQ NO: 9 comprises ΔL111/V221F; SEQ NO: 10 comprises ΔL111/ S226/R; SEQ NO: 11 comprises ΔL111/V221F/S226R. Thus, the attenuated oncolytic virus strain of Pat. 337 would read on the attenuated oncolytic virus strain of instant claims 1-11.
The claims of Pat. 337 further teach:
2. An oncolytic virus vaccine, wherein the oncolytic virus vaccine is prepared by inserting an antigen into the attenuated oncolytic virus strain according to claim 1.
3. The oncolytic virus vaccine according to claim 2, wherein the antigen is a specific tumor antigen.
4. The oncolytic virus vaccine according to claim 2, wherein the antigen is one selected from a group consisting of: NY-ESO-1, gp33, gp100, TX103, Mucin-1, WT-1, MART-1, MAGE A1, MAGE A3, MAGE A4, MAGE B2, PRAME, SURVIVIN, MART-1, col6A3, tyrosinase, T antigen, SLC45A2, VCX/Y, HPV, alpha-fetoprotein, carcinoembryonic antigen, CA 125, Her2, Dopachrome Tautomerase, BAGE Protein, GAGE Protein, Survivin, Tyrosinase, SSX2, Cyclin-A1, KIF20A, MUC5AC, Meloe, Lengsin, Kallikrein 4, IGF2B3, and Phosphatidylinositol proteoglycan 3.
5. An antitumor drug or a drug for treating cancer prepared from the oncolytic virus vaccine according to claim 2.
6. The antitumor drug or the drug for treating cancer according to claim 5, wherein the antitumor drug or the drug for treating cancer comprises both the oncolytic virus vaccine and immune cells.
Taken together, the claims of Pat. 337 teaches the oncolytic virus expressing a tumor antigen by inserting an antigen into the attenuated oncolytic virus strain; and the modified oncolytic strain can be used for oncolytic virus vaccine. The virus expressing a tumor antigen would read on the attenuated oncolytic virus strain encompassed by instant claims 13-15.
The claims of Pat. 337 teach as set forth above. However, the claims of Pat. 337 do not teach combination with an immune checkpoint inhibitor.
Lichty teachings are described above. In particular, Lichty teaches: 1) a pharmaceutical combination for use in the treatment of cancer or for use in the manufacture of a medicament for treating cancer in a mammal wherein the combination comprises an oncolytic virus and a checkpoint inhibitor. In some embodiments, the pharmaceutical combination comprises a human or humanized monoclonal antibody against CTLA4 or PD-1/PD-L1 and a modified VSV ([0020]); 2) addition of anti-PD1 antibody enhances the DCT boost and leads to a profound increase in survival when compared to prime/boost or anti-PD1 treatment alone ([0125], and Fig.15); 3) oncolytic virus treatment leads to an increase in PD-L1 expression (Example 4, [0143]).
It would have prima facie been obvious to one of ordinarily skilled in the art at the time the invention was filed to modify the composition taught by the claims of Pat. 337 and to make a combination of an attenuated oncolytic virus vaccine with an immune checkpoint inhibitor (e.g. PD-1 antibody) as taught by Lichty. One of ordinary skill in the art would have a reasonable expectation of success because Lichty teaches a checkpoint inhibitor (such as anti-PD1 antibody) can enhance the efficacy of oncolytic virus and oncolytic virus treatment leads to an increased expression of PD-L1. The motivation would have been to further improve the therapeutic activity of the oncolytic virus vaccine.
Regarding instant claims 18 and 19, claim 8 of Pat. 337 teaches that the antitumor drug or the drug for treating cancer according to claim 5, wherein a tumor or the cancer is one selected from a group consisting of: head and neck cancer, melanoma, soft tissue sarcoma, breast cancer, esophageal cancer, lung cancer, ovarian cancer, bladder cancer, liver cancer, cervical cancer, neuroblastoma, synovial sarcoma, and round cell liposarcoma.
Application No. 19/019, 594
Claims 1, 3, 5, 7, and 10-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-37 of copending Application No. 19/019, 594 (hereinafter, Appl. 594) in view of Lichty (Lichty et al., US 2019/0022203 A1, Publication Date: 01/2//4/2019).
The claims of Appl. 594 teach a recombinant oncolytic virus, comprising an M protein and an antigen encoded by an exogenous gene, wherein the M protein comprises the following site mutations compared to an amino acid sequence as shown in SEQ ID NO 1: mutating of methionine at position 51 into arginine (M51R); mutating of valine at position 221 into phenylalanine (V221F); and mutating of serine at position 226 into arginine (S226R) (claim 1).
The claims of Appl. 594 teach recombinant oncolytic virus according to claim 1, wherein the antigen is selected from hematological tumor antigens or solid tumor antigens (claim 2).
The claims of Appl. 594 teach the recombinant oncolytic virus according to claim 2, wherein: the solid tumor antigens comprise at least one of: …, CD74, CD80, CD86, CCAM5, CCAM6, p53, cMet, HGFR, MAGE-Al, MAGE-A2, MAGE-A3, MAGE-A4, MAGE-A6, MAGE-A10, MAGE-A12, …, NY-ESO-1, …, or MUC1 (claim 3).
The claims of Appl. 594 teach wherein the M protein further comprises one or more of the following site mutations: knocking out of leucine at position 111; or mutating of leucine at position 111 into alanine (L111A) (claim 10); wherein the M protein comprises an amino acid sequence as shown in SEQ ID NO 2, SEQ ID NO 3, SEQ ID NO 4, SEQ ID NO 5, SEQ ID NO 6, SEQ ID NO 7, SEQ ID NO 8, SEQ ID NO 9, SEQ ID NO 10 or SEQ ID NO 11 (claim 13). As shown below, SEQ ID NO: 4 of Appl. 594 are identical to SEQ ID NO: 4:
SEQ ID NO: 4 alignment:
Query Match 100.0%; Score 1221; Length 228;
Best Local Similarity 100.0%;
Matches 228; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MSSLKKILGLKGKGKKSKKLGIAPPPYEEDTSMEYAPSAPIDKSYFGVDERDTYDPNQLR 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MSSLKKILGLKGKGKKSKKLGIAPPPYEEDTSMEYAPSAPIDKSYFGVDERDTYDPNQLR 60
Qy 61 YEKFFFTVKMTVRSNRPFRTYSDVAAAVSHWDHMYIGMAGKRPFYKILAFGSSNLKATPA 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 YEKFFFTVKMTVRSNRPFRTYSDVAAAVSHWDHMYIGMAGKRPFYKILAFGSSNLKATPA 120
Qy 121 VLADQGQPEYHAHCEGRAYLPHRMGKTPPMLNVPEHFRRPFNIGLYKGTIELTMTIYDDE 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 VLADQGQPEYHAHCEGRAYLPHRMGKTPPMLNVPEHFRRPFNIGLYKGTIELTMTIYDDE 180
Qy 181 SLEAAPMIWDHFNSSKFSDFREKALMFGLIVEKKASGAWFLDSIRHFK 228
||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 SLEAAPMIWDHFNSSKFSDFREKALMFGLIVEKKASGAWFLDSIRHFK 228
As set forth above, SEQ NO: 4 comprises M51R/ΔL111/V221F/S226R mutations.
The claims of Appl. 594 teach that the recombinant oncolytic virus according to a claim 1, further comprising an Indiana MuddSummer subtype strain of the VSV (claim 24).
Taken together, the claims of Appl. 594 teaches the attenuated oncolytic virus of instant claims 1, 3, 5, 7, 10-15.
The claims of Appl. 594 teach a pharmaceutical composition, comprising the recombinant oncolytic virus according to claim 1, and a pharmaceutically acceptable carrier (claim 37).
The claims of Appl. 594 teach as set forth above. However, the claims of Appl. 594 do not teach combination with an immune checkpoint inhibitor.
Lichty teachings are described above. In particular, Lichty teaches: 1) a pharmaceutical combination for use in the treatment of cancer or for use in the manufacture of a medicament for treating cancer in a mammal wherein the combination comprises an oncolytic virus and a checkpoint inhibitor. In some embodiments, the pharmaceutical combination comprises a human or humanized monoclonal antibody against CTLA4 or PD-1/PD-L1 and a modified VSV ([0020]); 2) addition of anti-PD1 antibody enhances the DCT boost and leads to a profound increase in survival when compared to prime/boost or anti-PD1 treatment alone ([0125], and Fig.15); 3) oncolytic virus treatment leads to an increase in PD-L1 expression (Example 4, [0143]).
It would have prima facie been obvious to one of ordinarily skilled in the art at the time the invention was filed to modify the composition taught by the claims of Appl. 594 and to make a combination of an attenuated oncolytic virus vaccine with an immune checkpoint inhibitor (e.g. PD-1 antibody) as taught by Lichty. One of ordinary skill in the art would have a reasonable expectation of success because Lichty teaches a checkpoint inhibitor (such as anti-PD1 antibody) can enhance the efficacy of oncolytic virus and oncolytic virus treatment leads to an increased expression of PD-L1. The motivation would have been to further improve the therapeutic activity of the oncolytic virus vaccine.
Regarding instant claims 18 and 19, claims Appl. 594 teach the recombinant oncolytic virus is used in preparing a medicine for at least one of preventing or treating at least one of a disease or disorder (claim 32); wherein the recombinant oncolytic virus is used for sustained killing of an abnormal cell (claim 33); wherein the abnormal cell is selected from a tumor cell and a cell associated with tumor tissue (claim 34); wherein the tumor comprises acute lymphoblastic leukemia, acute B-cell leukemia, chronic non-lymphocytic leukemia, non-Hodgkin's lymphoma, anal cancer, astrocytoma, basal cell carcinoma, bile duct cancer, bladder cancer, mastocarcinoma, breast cancer, cervical cancer, chronic myeloproliferative tumors, colorectal cancer, endometrial cancer, ependymoma, esophageal cancer, …, thyroid cancer, uterine cancer, vaginal cancer and vascular tumor (claim 36).
This is a provisional nonstatutory double patenting rejection.
Application No. 19/019, 715
Claims 1, 3, 5, 7, and 10-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of copending Application No. 19/019, 715 (hereinafter, Appl. 715) in view of Lichty (Lichty et al., US 2019/0022203 A1, Publication Date: 01/2//4/2019).
The claims of Appl. 715 teach a recombinant oncolytic virus, comprising an M protein and a cytokine encoded by an exogenous gene, wherein the M protein comprises the following site mutations compared to an amino acid sequence as shown in SEQ ID NO 1: mutating of methionine at position 51 into arginine (M51R); mutating of valine at position 221 into phenylalanine (V221F); and mutating of serine at position 226 into arginine (S226R) (claim 1).
The claims of Appl. 715 teach wherein the M protein comprises an amino acid sequence as shown in SEQ ID NO 2, SEQ ID NO 3, SEQ ID NO 4,… (claim 6).
As shown below, SEQ ID NO: 4 of Appl. 715 are identical to SEQ ID NO: 4:
SEQ ID NO: 4 alignment:
Query Match 100.0%; Score 1221; Length 228;
Best Local Similarity 100.0%;
Matches 228; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MSSLKKILGLKGKGKKSKKLGIAPPPYEEDTSMEYAPSAPIDKSYFGVDERDTYDPNQLR 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MSSLKKILGLKGKGKKSKKLGIAPPPYEEDTSMEYAPSAPIDKSYFGVDERDTYDPNQLR 60
Qy 61 YEKFFFTVKMTVRSNRPFRTYSDVAAAVSHWDHMYIGMAGKRPFYKILAFGSSNLKATPA 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 YEKFFFTVKMTVRSNRPFRTYSDVAAAVSHWDHMYIGMAGKRPFYKILAFGSSNLKATPA 120
Qy 121 VLADQGQPEYHAHCEGRAYLPHRMGKTPPMLNVPEHFRRPFNIGLYKGTIELTMTIYDDE 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 VLADQGQPEYHAHCEGRAYLPHRMGKTPPMLNVPEHFRRPFNIGLYKGTIELTMTIYDDE 180
Qy 181 SLEAAPMIWDHFNSSKFSDFREKALMFGLIVEKKASGAWFLDSIRHFK 228
||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 SLEAAPMIWDHFNSSKFSDFREKALMFGLIVEKKASGAWFLDSIRHFK 228
As set forth above, SEQ ID NO: 4 comprises M51R/ΔL111/V221F/S226R mutations.
The claims of Appl. 715 teach that the recombinant oncolytic virus according to a claim 1, further comprising an Indiana MuddSummer subtype strain of the VSV (claim 20).
Taken together, the claims of Appl. 715 teach the attenuated oncolytic virus of instant claims 1, 3, 5, 7, 10 and 11.
The claims of Appl. 715 teach a pharmaceutical composition, comprising the recombinant oncolytic virus according to claim 1, and a pharmaceutically acceptable carrier (claim 30).
The claims of Appl. 715 teach as set forth above. However, the claims of Appl. 715 do not teach combination with an immune checkpoint inhibitor or the virus further expressing a tumor antigen.
Lichty teachings are described above. In particular, Lichty teaches: 1) a pharmaceutical combination for use in the treatment of cancer or for use in the manufacture of a medicament for treating cancer in a mammal wherein the combination comprises an oncolytic virus and a checkpoint inhibitor. In some embodiments, the pharmaceutical combination comprises a human or humanized monoclonal antibody against CTLA4 or PD-1/PD-L1 and a modified VSV ([0020]) expressing an tumor antigen (such as MAGE-A3, see Example 5); 2) addition of anti-PD1 antibody enhances the DCT boost and leads to a profound increase in survival when compared to prime/boost or anti-PD1 treatment alone ([0125], and Fig.15); 3) oncolytic virus treatment leads to an increase in PD-L1 expression (Example 4, [0143]).
It would have prima facie been obvious to one of ordinarily skilled in the art at the time the invention was filed to modify the composition taught by the claims of Appl. 715 and to make a combination of an attenuated oncolytic virus vaccine with an immune checkpoint inhibitor (e.g. PD-1 antibody) as taught by Lichty. One of ordinary skill in the art would have a reasonable expectation of success because Lichty teaches a checkpoint inhibitor (such as anti-PD1 antibody) can enhance the efficacy of oncolytic virus expressing a tumor antigen and oncolytic virus treatment leads to an increased expression of PD-L1. The motivation would have been to further improve the therapeutic activity of the oncolytic virus vaccine.
Regarding claims 12-15, Lichty teaches that vesicular stomatitis virus (VSV) engineered to express a tumor antigen can be used as an oncolytic viral immunotherapy ([0004], claim 17). Lichty teaches clinical trial with combination of oncolytic virus vaccine (MG1MA3) plus checkpoint inhibitor (Examples 4 and 5). Virus MG1MA3 comprises a MAGE-A3 ([0140]). It would have prima facie been obvious to one of ordinarily skilled in the art at the time the invention was filed to further expressing a tumor antigen (such as MAGE-A3) for an oncilytic viral immunotherapy as shown by Lichty. One of ordinary skill in the art would have a reasonable expectation that the oncolytic virus further expressing MAGE-A3 in combination with as anti-PD1 antibody would be effective in treating MAGE-A3 expressing tumors as demonstrated by Lichty.
Regarding claims 18 and 19, the claims of Appl. 715 teach the recombinant oncolytic virus is used in preparing a medicine for at least one of preventing or treating at least one of a disease or disorder (claim 25); wherein the recombinant oncolytic virus is used for sustained killing of an abnormal cell (claim26); wherein the abnormal cell is selected from a tumor cell and a cell associated with tumor tissue (claim 27); wherein the tumor comprises acute lymphoblastic leukemia, acute B-cell leukemia, chronic non-lymphocytic leukemia, non-Hodgkin's lymphoma, anal cancer, astrocytoma, basal cell carcinoma, bile duct cancer, bladder cancer, mastocarcinoma, breast cancer, cervical cancer, chronic myeloproliferative tumors, colorectal cancer, endometrial cancer, ependymoma, esophageal cancer, …, thyroid cancer, uterine cancer, vaginal cancer and vascular tumor (claim 29).
This is a provisional nonstatutory double patenting rejection.
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