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
Claims 1-20 are pending and under consideration.
It is noted that the specification discloses the antibodies below (see Tables: 1-3, 9, and 10):
Antibody
HCDRs: 1-3
VH
LCDRs: 1-3
VL
M1
SEQ ID NOs:6-7-8
SEQ ID NO: 24
SEQ ID NOs:9-14-19
SEQ ID NO: 25
M2
SEQ ID NOs:6-7-8
SEQ ID NO: 24
SEQ ID NOs:10-15-20
SEQ ID NO: 26
M3
SEQ ID NOs:6-7-8
SEQ ID NO: 24
SEQ ID NOs:11-16-21
SEQ ID NO: 27
M4
SEQ ID NOs:6-7-8
SEQ ID NO: 24
SEQ ID NOs:12-17-22
SEQ ID NO: 28
M5
SEQ ID NOs:6-7-8
SEQ ID NO: 24
SEQ ID NOs:13-18-23
SEQ ID NO: 29
V1
SEQ ID NOs:6-7-8
SEQ ID NO: 35
SEQ ID NOs:9-14-19
SEQ ID NO: 39
V2
SEQ ID NOs:6-7-8
SEQ ID NO: 36
SEQ ID NOs:9-14-19
SEQ ID NO: 39
V3
SEQ ID NOs:6-7-8
SEQ ID NO: 36
SEQ ID NOs:9-14-19
SEQ ID NO: 40
V4
SEQ ID NOs:6-7-8
SEQ ID NO: 37
SEQ ID NOs:9-14-19
SEQ ID NO: 41
V5
SEQ ID NOs:6-7-8
SEQ ID NO: 38
SEQ ID NOs:9-14-19
SEQ ID NO: 41
Prior art does not teach or suggest anti-B7-H3 antibodies with the specific CDR combinations as shown in the table above (noted: M1 and V1-V5 share same 6 CDRs). However, the claims encompass a broad genus of antibodies which are not supported by the specification (see 112(a) rejection).
Priority
It is acknowledged that this application is a 371 of International Application No. PCT/CN2022/122444 filed September 29, 2022, which claims the benefit of priority to Chinese Application No. 202111158382.7 filed September 30, 2021.
Certified copies of foreign priority applications have been received as required by 37 CFR 1.55. The priority date has been established as September 30, 2021.
Information Disclosure Statement
The Information Disclosure Statements filed on 03/29/2024 and 10/07/2025 have been considered and entered by examiner.
Sequence Interpretation
The Office interprets claims comprising SEQ ID NOs: in the following manner:
"comprising/having an amino acid sequence set forth in SEQ ID NO: xxx" requires only a 2mer of SEQ ID NO: xxx. It is noted that "comprising/having the amino acid sequence of SEQ ID NO: xxx" would require the full-length sequence with 100% identity to SEQ ID NO: xxx with any N-/C-terminal additions.
Claim Objections
Claim 1 is objected to because of the following informalities: “(a) a VH CDR1” should be “(a) a heavy chain variable region complementarity determining region 1 (VH CDR1)”. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: “(d) a VL CDR1” should be “(d) a light chain variable region CDR1 (VL CDR1)”. Appropriate correction is required.
Claim 2 is objected to because of the following informalities: “fragmen” at line 2 should be “fragment”. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 12, 19 and 20 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.
Regarding claim 12, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). It is noted that “such as” was used six times in claim 12.
In addition, claim 12 recites “wherein the method comprises administering to a patient in need thereof an effective dose of the antibody or the antigen binding fragment according to claim 1; or the disease is selected from …..; or the tumor is …”. The claim is ambiguous because by reciting “or” (not “and wherein”), each limitation is optional. Given Broadest Reasonable Interpretation (BRI), even the step of “administering to a patient in need thereof an effective dose of the antibody or the antigen binding fragment according to claim 1” is also an optional step. Furthermore, because the option 2 (“or the disease is selected from…” ) and option 3 (“or the tumor is…”) are alternative, there is insufficient antecedent basis for the limitation “or the tumor” in the claim.
Regarding claim 19, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). It is noted that “such as” was used six times in claim 19.
In addition, claim 19 recites “wherein the method comprises administering to a patient in need thereof an effective dose of the antibody or the antigen binding fragment according to claim 6; or the disease is selected from …..; or the tumor is …”. The claim is ambiguous because by reciting “or” (not “and wherein”), each limitation is optional. Given Broadest Reasonable Interpretation (BRI), even the step of “administering to a patient in need thereof an effective dose of the antibody or the antigen binding fragment according to claim 6” is also an optional step. Furthermore, because the option 2 (“or the disease is selected from…” ) and option 3 (“or the tumor is…”) are alternative, there is insufficient antecedent basis for the limitation “or the tumor” in the claim.
Regarding claim 20, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). It is noted that “such as” was used six times in claim 20.
In addition, claim 20 recites “wherein the method comprises administering to a patient in need thereof an effective dose of the antibody or the antigen binding fragment according to claim 9; or the disease is selected from …..; or the tumor is …”. The claim is ambiguous because by reciting “or” (not “and wherein”), each limitation is optional. Given Broadest Reasonable Interpretation (BRI), even the step of “administering to a patient in need thereof an effective dose of the antibody or the antigen binding fragment according to claim 9” is also an optional step. Furthermore, because the option 2 (“or the disease is selected from…” ) and option 3 (“or the tumor is…”) are alternative, there is insufficient antecedent basis for the limitation “or the tumor” in the claim.
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 1-20 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 1 is drawn to an antibody or an antigen-binding fragment which encompasses a broad genus of antibodies specifically binds to B7-H3. By reciting “comprises one or more of amino acid sequence of (a)-(f)…”, given Broadest Reasonable Interpretation (BRI), the claim encompasses B7-H3 antibodies with partial CDRs. For example, antibodies comprising only VH CDR1 of SEQ ID NO:6 would be encompassed by instant claim 1. Thus, the claimed “antibodies or antigen-binding fragment” encompasses a large number of antibodies without the complete HCDRs 1-3 and LCDRs 1-3 structure. Additionally, claim 1 (and claims 4, 6, 8, 9, and 14) recites specific sequence as: “comprising/having an amino acid sequence of SEQ ID NO: xxx”. As such by the recitation of “an” that is underlined and italicized above, the recited sequences encompass partial sequences of SEQ ID NO: xxx (i.e., “an amino acid sequence of” rather than “the amino acid sequence of” a recited SEQ ID NO).
The specification teaches 10 different antibodies which comprise the specific HCDRs 1-3 and LCDRs 1-3 combinations (5 different CDR combinations) as shown below:
Antibody
HCDRs: 1-3
LCDRs: 1-3
M1
SEQ ID NOs:6-7-8
SEQ ID NOs:9-14-19
M2
SEQ ID NOs:6-7-8
SEQ ID NOs:10-15-20
M3
SEQ ID NOs:6-7-8
SEQ ID NOs:11-16-21
M4
SEQ ID NOs:6-7-8
SEQ ID NOs:12-17-22
M5
SEQ ID NOs:6-7-8
SEQ ID NOs:13-18-23
V1
SEQ ID NOs:6-7-8
SEQ ID NOs:9-14-19
V2
SEQ ID NOs:6-7-8
SEQ ID NOs:9-14-19
V3
SEQ ID NOs:6-7-8
SEQ ID NOs:9-14-19
V4
SEQ ID NOs:6-7-8
SEQ ID NOs:9-14-19
V5
SEQ ID NOs:6-7-8
SEQ ID NOs:9-14-19
The specification does not disclose other antibodies with other CDR variants, or CDR variant combinations encompassed by the claims with claimed properties, e.g. binding to B7-H3 or treating cancers or other diseases. Thus, these claims lack written description because the specification lacks a representative number of species that satisfies the entirety of the genus.
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".
On 22 February 2018, the USPTO provided a Memorandum clarifying the Written Description Guidelines for claims drawn to antibodies, which can be found at www.uspto.gov/sites/default/files/documents/amgen_22feb2018.pdf. That Memorandum indicates that, in compliance with recent legal decisions, the disclosure of a fully characterized antigen no longer is sufficient written description of an antibody to that antigen. Accordingly, the instant claims have been evaluated in view of that guidance.
By the time the invention was made, it is well established in the art that the formation of an intact antigen-binding site in an antibody usually required the association of the complete heavy and light chain variable regions of a given antibody, each of which consists of three "complementarity determining regions" ("CDRs") which provide the majority of the contact residues for the binding of the antibody to its target epitope. Even a single point mutation in HCDR1 region could lead to antibody lose its binding activity (Ni et al., The Protein Journal, 43, pp. 683-696, July 2024, see Abstract). Thus, the specific antibody disclosed by the specification (e.g. 19L04) would not tell structure of other antibodies with CDR variants encompassed by rejected claims. Wong (Wong et al., MABS, 2021, Vol. 13, No. 1, e1873478, Publication Year: 2021) teaches that sequence-distant antibodies can target the same epitope (Abstract). Thus, one ordinary skill in the art would not be able to visualize other antibody encompassed by the claim, which specifically binds to B7-H3, based on the 10 antibodies disclosed in the specification.
In addition, the claims identify the antibodies by function only, where the function is to:
Specifically binding to B7-H3;
treating diseases, including a tumor, a respiratory disease, a skin and musculoskeletal disease, a genitourinary disease, a nervous system disease and a digestive system disease (claims 12, 19 and 20).
The specification and prior art have not established the relationship between the claimed functions and the structure of the antibody. One of ordinary skilled in the art would not be able to readily recognize/visualize an antibody with required properties. Taken together, applicant has not provided sufficient evidence to show that the inventors possess a genus of antibodies or antibody fragments binding to B7-H3.
Although Applicants may argue that it is possible to screen for antibodies with claimed properties/functions, the court found in (Rochester v. Searle, 358 F.3d 916, Fed Cir., 2004) that screening assays are not sufficient to provide adequate written description for an invention because they are merely a wish or plan for obtaining the claimed chemical invention. "As we held in Lilly, "[a]n adequate written description of a DNA ... 'requires a precise definition, such as by structure, formula, chemical name, or physical properties,' not a mere wish or plan for obtaining the claimed chemical invention." 119 F.3d at 1566 (quoting Fiers, 984 F.2d at 1171 ). For reasons stated above, that requirement applies just as well to non-DNA (or RNA) chemical inventions." Knowledge of screening methods provides no information about the structure of any future antibodies or antibody fragments encompassed by the claims that may function as claimed.
Claim 2 recites only VH CDRs and encompasses unlimited sequences and combinations of VL CDRs, which are not supported by the instant specification.
Claim 3 recites VL CDRs and encompasses different combinations of VL CDRs and unlimited sequences and combinations of VH CDRs, which are not supported by the instant specification.
Claims 4, 6 and 9 recite specific HCDRs 1-3 and LCDRs 1-3 combinations (claim 4), or specific heavy + light chain variable domain combinations (claims 6 and 9). However, these claims recite specific sequence as: “comprising/having an amino acid sequence set forth in SEQ ID NO: xxx”. As set forth above, the recited sequences encompass partial sequences of SEQ ID NO: xxx (i.e., “an amino acid sequence set forth in” rather than “the amino acid sequence of” a recited SEQ ID NO). The specification does not have the support for partial CDRs encompassed by the claims.
Claim 5 encompasses 1) antibodies with only recited heavy chain variable region or with only recited light chain variable region; and 2) antibody variants with different CDRs and/or different frame region. As set forth above, the instant specification does not support antibodies with partial CDR structures.
Claims 7, 8, 10-20 encompass the claimed invention of claim 1, claim 6 or claim 9.
For claims 12, 19 and 20, the claims further recite diagnosing and/or treating a disease e.g. a tumor, a respiratory disease, a skin and musculoskeletal disease, a genitourinary disease, a nervous system disease and a digestive system disease. These diseases vary significantly and normally require different treatments. For example, a tumor at least includes a hematological tumor or a solid tumor; or the tumor is a tumor positive for B7-H3 expression; or the tumor is selected from melanoma, lung cancer such as non-small cell lung cancer, colorectal cancer, head and neck cancer, kidney cancer, prostate cancer such as castration-resistant prostate cancer, breast cancer, gastric cancer, liver cancer such as hepatocellular carcinoma, cervical cancer, ovarian cancer such as ovarian epithelial carcinoma, glioma such as childhood brain stem glioma, pancreatic cancer such as pancreatic ductal carcinoma, leukemia, mesothelioma, squamous cell carcinoma, neuroblastoma, desmoplastic small round cell tumor, medulloblastoma, meningioma, peritoneal malignancy, sarcoma, brain cancer, central nervous system tumor and metastatic brain tumor. These cancers are not a single disease, or cluster of closely related disorders. These cancers are highly heterogeneous at both the molecular and clinical level. B7-H3 antibodies have been used in treating B7H3-overexpressing cancers (as evidenced by Kontos et al., Clin Cancer Res; 27(5), March 1, 2021, pages: 1227-1235, see Abstract and Table 1). The specification and prior art does not show any therapeutic activity of any disclosed B7H3 antibody to diseases, except B7H3 over-expressing cancers. Thus, one of ordinary skill in the art would not be able to readily visualize antibodies encompassed by the claims with required therapeutic activity for claimed diseases which may or may not be associated with B7-H3.
Therefore, for all these reasons the specification lacks adequate written description, and one of skill in the art cannot reasonably conclude that Applicant had possession of the claimed invention at the time the instant application was filed.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 and 14-21 of copending Application No. 18/701,217 (hereinafter Appl. 217) in view of Kontos (Kontos et al., Clin Cancer Res; 27(5), pages: 1227-1235, Publication Date: 03/01/2021) and Benatuil (Benatuil et al., US 2020/0338209 A1, Publication Date: 10/29/2020, cited in IDS of 10/07/2025).
Claim 1 of Appl. 217 teaches an antibody-drug conjugate or a pharmaceutically acceptable salt or solvate thereof, comprising an antibody or an antigen-binding unit thereof conjugated to a drug via a linker, wherein the antibody or the antigen-binding unit thereof specifically binds to B7-H3 and comprises one or more of amino acid sequences of (a)-(f): (a) a VH CDR1 comprising an amino acid sequence set forth in SEQ ID NO: 6; (b) a VH CDR2 comprising an amino acid sequence set forth in SEQ ID NO: 7; (c) a VH CDR3 comprising an amino acid sequence set forth in SEQ ID NO: 8; (d) a VL CDR1 comprising an amino acid sequence set forth in any one of SEQ ID NOs: 9-13; (e) a VL CDR2 comprising an amino acid sequence set forth in any one of SEQ ID NOs: 14-18; and (f) a VL CDR3 comprising an amino acid sequence set forth in any one of SEQ ID NOs: 19-23.
Claim 10 of Appl. 217 teaches wherein the antibody comprises a heavy chain variable region of the antibody or the antigen-binding unit thereof comprises an amino acid sequence set forth in SEQ ID NO: 24, and a light chain variable region of the antibody or the antigen-binding unit thereof comprises an amino acid sequence set forth in SEQ ID NO: 25; or a heavy chain of the antibody comprises a heavy chain variable region having an amino acid sequence set forth in SEQ ID NO: 24 and a heavy chain constant region having an amino acid sequence set forth in SEQ ID NO: 32; a light chain of the antibody comprises a light chain variable region having an amino acid sequence set forth in SEQ ID NO: 25 and a light chain constant region having an amino acid sequence set forth in SEQ ID NO: 34. As shown below, SEQ ID NOs: 24, 25, 32 and 34 of Appl. 217 are identical to SEQ ID NOs: 24, 25, 32 and 34 of the instant application, respectively:
SEQ ID NO: 24 alignment:
US-18-701-217-24
Query Match 100.0%; Score 619; DB 1; Length 115;
Best Local Similarity 100.0%;
Matches 115; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 QVQLQQSGPELVKPGASVRISCKASGYTFTDYDINWVQQRPGQGLEWIGWIFPGDDTTKY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 QVQLQQSGPELVKPGASVRISCKASGYTFTDYDINWVQQRPGQGLEWIGWIFPGDDTTKY 60
Qy 61 NEKFKGRATLTADKSSNTAYMQLNGLTSENSAVYFCARSPSFDYWGQGTLVTVSS 115
|||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 NEKFKGRATLTADKSSNTAYMQLNGLTSENSAVYFCARSPSFDYWGQGTLVTVSS 115
SEQ ID NO: 25 alignment:
US-18-701-217-25
Query Match 100.0%; Score 548; DB 1; Length 105;
Best Local Similarity 100.0%;
Matches 105; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 QIVLTQSPAIMSASPGERVTMTCSASSTIGFMYWYQQKPGTSPKRWIYDTSKLASGVPAR 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 QIVLTQSPAIMSASPGERVTMTCSASSTIGFMYWYQQKPGTSPKRWIYDTSKLASGVPAR 60
Qy 61 FSVSGSGTSYSLTISSMEAEDAATYYCHQRSSYPTFGGGTKLEIK 105
|||||||||||||||||||||||||||||||||||||||||||||
Db 61 FSVSGSGTSYSLTISSMEAEDAATYYCHQRSSYPTFGGGTKLEIK 105
SEQ ID NO: 32 alignment:
US-18-701-217-32
Query Match 100.0%; Score 1767; DB 1; Length 330;
Best Local Similarity 100.0%;
Matches 330; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 ASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSS 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 ASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSS 60
Qy 61 GLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGG 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 GLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGG 120
Qy 121 PSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYN 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 PSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYN 180
Qy 181 STYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSRDE 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 STYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSRDE 240
Qy 241 LTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRW 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 LTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRW 300
Qy 301 QQGNVFSCSVMHEALHNHYTQKSLSLSPGK 330
||||||||||||||||||||||||||||||
Db 301 QQGNVFSCSVMHEALHNHYTQKSLSLSPGK 330
SEQ ID NO: 34 alignment:
US-18-701-217-34
Query Match 100.0%; Score 553; DB 1; Length 107;
Best Local Similarity 100.0%;
Matches 107; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 RTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQD 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 RTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQD 60
Qy 61 SKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC 107
|||||||||||||||||||||||||||||||||||||||||||||||
Db 61 SKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC 107
As evidenced by the Specification of Appl. 217, SEQ ID NO: 32 is IgG1 heavy chain constant region (see page 9 of Specification of 04/12/2024), thus, the antibody is IgG isotype.
Claim 12 of Appl. 217 teaches a pharmaceutical composition comprises the antibody-drug conjugate.
Thus, the antibody or antigen-binding fragment disclosed by Appl. 271 read on the antibody of instant claims 1-9, 13, and 14. However, the claims of Appl. 271 is drawn to antibody-drug conjugates not to the antibody, or method of use the antibody, or nucleotide encoding the antibody, or expression vector and host cell expressing the antibody.
Kontos teaches that B7-H3 inhibits tumor antigen-specific immune responses, leading to a protumorigenic effect. As a result, B7-H3 expression in tumors is associated with poor prognosis (Abstract).
Kontos teaches that B7-H3 is an attractive target for antibody-based immunotherapy for B7-H3 overexpressing cancers (Abstract).
Kontos teaches that different anti-B7-H3 antibodies have been developed for cancer therapy, including prostate cancer, head and neck cancer, advanced CNS (Table 1). B7-H3 blocking with mAbs has been shown to increase CD8+ T-cell and NK-cell tumor infiltration and reduce tumor growth, and/or prolong survival in mouse models of hematopoietic cancers, melanoma, colorectal cancer, and more recently, ovarian cancer (page 1230, col. 2, para. 5).
Benatuil teaches the method of making antibodies (e.g. anti-hB7-H3 antibody) by introducing expression vector encoding the heavy and light chains in to a host cell ([0436]-[0439], and Example 6). The expression vector would have a polynucleotide encoding the antibody.
Benatuil teaches pharmaceutical composition comprising anti-hB7-H3 antibody and a pharmaceutically acceptable carrier (claim 45).
It would have prima facie been obvious to one of ordinarily skilled in the art before the time the invention was filed to make the anti-B7-H3 antibody taught by the claims of Appl. 271 (providing the sequence of the antibody) and Benatuil (providing the method of making the antibody) and to use the antibody for treating cancers overexpressing B7-H3. One of ordinary skill in the art would have had a reasonable expectation of success that the antibody would be effective because Kontos teaches: B7-H3 inhibits tumor antigen-specific immune responses, leading to a protumorigenic effect; B7-H3 antibody are promising in treating various cancers. The motivation would have been to expand options for therapy targeting B7-H3.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis can be reached at (571)270-3503. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHENG LU/ Examiner, Art Unit 1642
/SAMIRA J JEAN-LOUIS/Supervisory Patent Examiner, Art Unit 1642
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