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 .
Status of the Claims
Claims 1 – 21, 23 – 24 and 26 are currently pending, with non-elected claims 16 – 19, 23 and 26 withdrawn from consideration. Claims 1 – 15, 20 – 21 and 24 are the subject of this Office Action. This is the first Office Action on the merits of the claims.
Election/Restrictions
Claims 16 – 19, 23 and 26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 03/11/2026.
Response to Arguments
On pages 18 – 22, Applicant responds to the Restriction Requirement of 01/16/2026 with traverse. On the reply of 03/11/2026, Applicant argues that “Groups I-III are so linked as to form a single general inventive concept, thus possessing unity of invention. Specifically, the ‘special technical features’ of the claims in Groups I-III lie in the specific 3 CDR combination OX40-targeted antibody or an antigen-binding fragment thereof defined in claim 1” (p. 18, last paragraph).
Applicant’s argument has been considered but not found persuasive because, although specific CDR sequences are recited in independent claim 1, a significant amount of variations to the CDRs are also claimed as alternatives, and it is not clear what mutations are claimed by present claim 1 (see rejection under 112(b) below). As written, any antibody that binds to OX40 reads on present claim 1.
Priority
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.
For the purposes of applying prior art, the PCT application filing date of 06/26/2021 is applied.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/01/2023 is in compliance with the provisions of 37 CFR 1.97 and has been considered.
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 – 15, 20 – 21 and 24 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.
At the time the invention was made, the art teaches that there is an interest in optimizing natural properties (affinity, specificity, stability, solubility, and effector function) in antibodies. A common challenge during antibody optimization is that improvements in one property (e.g. affinity) can lead to deficits in other properties (e.g. stability). See RABIA (Rabia LA, et al. Understanding and overcoming trade-offs between antibody affinity, specificity, stability and solubility. Biochem Eng J. 2018 Sep 15;137:365-374; see PTO-892: Notice of References Cited), abstract. RABIA teaches that the most important antibody properties are mediated by their complementary-determining regions (CDRs) within the variable heavy and light regions (variable heavy, VH, and variable light, VL). See RABIA, Introduction.
The claims are drawn to amino acid changes. Claim 2 indicates changes to HCDRs of SEQ ID NOs: 10, 44, and 86. Table b, paragraph 0071, of the present specification identifies the antibody with the sequences of SEQ ID NOs: 10, 44, and 86 as PR002067. Furthermore, Table 1-1, pgs. 40 – 41, indicates changes to the HCDRs of other anti-OX40 antibodies in comparison to those of PR002067.
Given RABIA’s teaching that mutations can affect the function of the antibody, the mutations in Table 1-1 are analyzed to determine what amino acid residues can be changed and still result in an antibody that binds to OX40. Considering, for example, “wherein the mutation is an insertion, deletion or substitution of 3, 2 or 1 amino acids on the basis of the amino acid sequences of the VH CDR1, VH CDR2 and VH CDR3 of the VH” is taken to mean that the insertion, deletion or substitution of 3, 2 or 1 amino acids is in HCDR1, the specification does not support the scope of this limitation because an insertion, deletion of 3, 2 or 1 amino acids in HCDR1 would result in HCDR that may be significantly different than the HCDR1s of the anti-OX40 antibodies of Table 1-1, which do not vary much in view of the scope of those limitations. When the HCDR1s of Table 1-1 do vary, it is often a substitution with an amino acid in a limited group of several amino acids (not all 20 amino acids). None of the HCDR1s of Table 1-1 includes is an insertion or deletion of 3, 2 or 1 amino acids when compared to the HCDR1 of PR002067 (SEQ ID NO: 10). Given RABIA, one cannot predict that any combination of amino acid changes in the CDRs would result in one that binds OX40.
Thus, based on the teachings of RABIA regarding the lack of predictability in the art, one having ordinary skill would conclude that the applicant was not in possession of the claimed genus of antibodies or antigen-binding antibody fragments that specifically bind to OX40 having the claimed mutations as recited in present claim 1.
Furthermore, in Amgen Inc. et al. v. Sanofi et al., 598 U.S. 594, 2023 USPQ2d 602 (2023), the Supreme Court, held that claims drawn to a genus of monoclonal antibodies, which were functionally claimed by their ability to bind to a specific protein, PCSK9, were invalid due to lack of enablement. The claims at issue were functional, in that they defined the genus by its function (the ability to bind to specific residues of PCSK9) as opposed to reciting a specific structure (the amino acid sequence of the antibodies in the genus). See MPEP 2164.01.
Because the presently claimed OX40-targeted antibody composition is drawn to a variety of mutations resulting in a variety of structures, it is only defined by functional properties (ability to target OX40) with no specific structure recited in the claims. In view of the fact patterns detailed in Amgen Inc. et al. v. Sanofi et al., the applicant is not in possession of an OX40-targeted antibody which is enabled.
Claims 1 – 15, 20 – 21 and 24 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 enablement requirement. The claims contain subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Scope of Enablement
Claims 1 – 15, 20 – 21 and 24 are rejected under 35 U.S.C. 112(a) because the claims recite “an OX40-targeted antibody or an antigen-binding fragment thereof, comprising a heavy chain variable region (VH), wherein the VH comprises the following complementarity determining regions (CDRs) or mutations thereof: VH CDR1 with an amino acid sequence as set forth in SEQ ID NO: 10; VH CDR2 with an amino acid sequence as set forth in SEQ ID NO: 44; and VH CDR3 with an amino acid sequence as set forth in SEQ ID NO: 86, SEQ ID NO: 84 or SEQ ID NO: 89; wherein the mutation is an insertion, deletion or substitution of 3, 2 or 1 amino acids on the basis of the amino acid sequences of the VH CDR1, VH CDR2 and VH CDR3 of the VH” but and thus do not require specific CDRs.
Because the CDRs confer specificity and function to an OX40-targeted antibody or antigen-binding fragment thereof, one with significant variations at the CDRs may not function as intended.
In this regard, the application disclosure and claims have been compared per the factors indicated in the decision In re Wands, 8 USPQ 2d 1400 (Fed. Cir., 1988) as to undue experimentation. The factors include:
1) the nature of the invention;2) the scope or breadth of the claims;3) the state of the prior art;4) the predictability or unpredictability of the art; 5) the relative skill of those skilled in the art; 6) the presence or absence of working examples; 7) the amount of direction or guidance presented and,8) the quantity of experimentation necessary.
The relevant factors are addressed below on the basis of comparison of the disclosure, the claims and the state of the prior art in the assessment of undue experimentation.
Scope or breadth of the claims: Present independent claim 1 and dependent claims thereon recite:
1. An OX40-targeted antibody or an antigen-binding fragment thereof, comprising a heavy chain variable region (VH), wherein the VH comprises the following complementarity determining regions (CDRs) or mutations thereof: VH CDR1 with an amino acid sequence as set forth in SEQ ID NO: 10; VH CDR2 with an amino acid sequence as set forth in SEQ ID NO: 44; and VH CDR3 with an amino acid sequence as set forth in SEQ ID NO: 86, SEQ ID NO: 84 or SEQ ID NO: 89; wherein the mutation is an insertion, deletion or substitution of 3, 2 or 1 amino acids on the basis of the amino acid sequences of the VH CDR1, VH CDR2 and VH CDR3 of the VH.
Degree of predictability or unpredictability in the art: As taught by RABIA, given that the maximal chemical diversity of antibody CDRs is unimaginably large (>1078 antibody variants based on 20 different amino acids at ~60 sites in the CDRs), it is extremely challenging to define the sequence determinants of antibody specificity (see 3. Antibody affinity/specificity trade-offs, second paragraph, p.4). Thus, the level of unpredictability in the art is high, especially since the claims results in CDRs that vary greatly from the antibodies presented in the present specification.
Relative skill possessed by those in the art: In view of the state and complexity of the prior art, and the scope of the claims, which are drawn to an antibody or antigen-binding antibody fragment that specifically binds to OX40, the level of skill in the art is high and is at least that of a medical doctor or Ph.D. scientist with several years of experience in the fields of antibody or antibody engineering and/or immunotherapy.
Presence or absence of working examples: The specification does not provide examples that define the effects resulting from all the possible alterations of the CDRs of the claimed antibody or antigen-binding antibody fragment that specifically binds to OX40, nor does the specification provide any examples of sequences lacking significant sequence identity with the disclosed CDRs (e.g., of PR002067). Examples are not provided of antibody derivatives that specifically binds to OX40 and have all the possible combinations recited in claim 1 or deviate significantly from the six CDRs of working sequences.
Amount of guidance or direction provided/Quantity of experimentation required: The specification only provides guidance regarding the effects of an antibody with specific CDRs and does not include any direction on how to prepare antibody or antigen-binding antibody fragments that specifically binds to OX40 that may be of the large variety of combinations of substitutions that still function as claimed. In the absence of working examples, undue experimentation would be necessary to determine the structure and scope of antibody or antigen-binding antibody fragment that specifically binds to OX40 (if any) that fall within the bounds of the claim, but which lack significant sequence identity with the specific CDR sequences disclosed, and/or that lack 100% identity to all six CDRs of several specific antibodies listed in the specification.
In summary, the claims allow for significant variations in the CDRs on the antibody or antigen-binding antibody fragment that specifically binds to OX40 and thus contain subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
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 – 15, 20 – 21 and 24 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 “wherein the mutation is an insertion, deletion or substitution of 3, 2 or 1 amino acids on the basis of the amino acid sequences of the VH CDR1, VH CDR2 and VH CDR3 of the VH.” It is not clear if one, two, all three combined or each of the VH CDRs have an insertion, deletion or substitution of 3, 2 or 1 amino acids. Claims 2 – 15, 20 – 21 and 24 depend from claim 1, either directly or indirectly, and thus inherit the deficiencies of claim 1.
Regarding claims 2 – 3, 7, 10 – 12, 21 and 23, the phrase "for example" or the term "preferably" renders the claims indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 2 recites the phrase “for example”.
Claim 3 recites “preferably”, “more preferably” and “even more preferably”.
Claim 7 recites “preferably”.
Claim 10 recites “preferably”.
Claim 11 recites “preferably”, “more preferably”.
Claim 12 recites the phrase “for example”, “preferably” and “more preferably”.
Claim 21 recites “preferably”.
Claim 23 recites “preferably”.
The examples provided are exemplary language that follows a generic limitation and which is then followed by more specific examples of the generic limitation, thus making it unclear if the limitation(s) following the exemplary language are necessarily required by the claim language as written.
For example, the language “includes, but is not limited to…” from the phrase “the conjugate moiety includes, but is not limited to, a detectable label, a drug toxin, a cytokine, a radionuclide, an enzyme, or a combination thereof” of present claim 20 is exemplary language. It is not clear whether the conjugate moiety necessarily requires the presence of one of the recited specific types of moieties or can encompass embodiments where the conjugate moiety does not comprise one of the recited moieties.
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 – 15, 20 – 21 and 24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 21 of copending Application No. 18/013,523 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because copending claim 1 recites a binding protein comprising at least two protein functional regions, comprising a first protein functional region and a second protein functional region, wherein the first protein functional region comprises a targeting moiety binding to an antigen on a target cell, and the second protein functional region comprises an effector moiety binding to an antigen on an immune effector cell; the binding protein is selected from the following structures: (I) the first protein functional region is of a Fab structure, the second protein functional region is of a VH structure, and the first protein functional region and the second protein functional region are arranged from the N-terminus to the C-terminus of the binding protein; and (II) the first protein functional region is of a Fab structure, the second protein functional region is of a Fab structure, and the first protein functional region and the second protein functional region are arranged from the N-terminus to the C-terminus of the binding protein; the binding protein is of (a) a monomeric structure, or (b) a dimeric structure consisting of two monomers.
Copending claim 4 recites that the antigen on the target cell is a tumor antigen or a co-inhibitory molecule antigen; wherein the tumor antigen is OX40.
Copending claim 10 recites that the antibody targeting OX40 or the antigen-binding fragment thereof comprises VH with a sequence as set forth in SEQ ID NO: 162. Copending claim 20 also recites the copending SEQ ID NO: 162.
Copending claim 19 recites that the antibody targeting OX40 or the antigen-binding fragment thereof comprises a heavy chain with a sequence as set forth in SEQ ID NO: 193.
Copending claim 21 recites a polypeptide chain 2 with a sequence as set forth in SEQ ID NOs: 233, 236, 238, 241, 242, 243, 273, 274.
Copending SEQ ID NOs: 162, 193, 233, 236, 238, 241, 242, 243, 273, 274 of the copending claims teach the HCDRs of present SEQ ID NOs: 10, 44, and 86 of present claims 1 – 3 with 100% identity. See Appendix.
Thus, copending claims anticipates the present claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1 – 15, 20 – 21 and 24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 17, 19 and 21 – 22 of copending Application No. 18/013,530 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because copending claim 1 recites a binding protein comprising at least two protein functional regions, wherein the binding protein comprises a protein functional region A and a protein functional region B; the protein functional region A and the protein functional region B target different antigens or different epitopes on the same antigen; wherein the protein functional region A is of a Fab structure; the protein functional region B is of a VH structure, and the binding protein further comprises an Fc homodimer; the number of the protein functional region A is two, and the number of the protein functional region B is two; the binding protein is of a left-right symmetric structure; the binding protein comprises a protein functional region A, a protein functional region B and an Fc homodimer sequentially from the N-terminus to the C-terminus, wherein the protein functional region A is linked to the protein functional region B via a first linker peptide (L1), and the protein functional region B is linked to the Fc via a second linker peptide (L2).
Copending claim 3 recites that the antigen is OX40.
Copending claim 5 recites that the OX40 antibody or the antigen-binding fragment thereof comprises a heavy chain variable region (VH), wherein the VH comprises an amino acid sequence as set forth in SEQ ID NO: 112.
Copending claim 7 recites that the protein functional region B comprises a heavy chain variable region with an amino acid sequence as set forth in SEQ ID NO: 112.
Copending claim 8 recites that the second polypeptide chain comprises an amino acid sequence as set forth in SEQ ID NO: 156.
Copending SEQ ID NOs: 112 and 156 of copending claims 5 and 7 – 8 teach the HCDRs of present SEQ ID NOs: 10, 44, and 86 with 100% identity. See Appendix.
Thus, copending claims anticipates the present 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Estella Gustilo whose telephone number is (703)756-1706. The examiner can normally be reached Monday - Friday 9:30 AM - 5:30 PM.
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, Gregory Emch can be reached at 571-272-8149. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ESTELLA M. GUSTILO/Examiner, Art Unit 1646
/GREGORY S EMCH/Supervisory Patent Examiner, Art Unit 1678
APPENDIX
Alignment with the HCDRs with SEQ ID NOs: 10, 44, 86
RESULT 1
US-18-013-523-162
(NOTE: this sequence has 2 duplicates in the database searched.
See complete list at the end of this report)
Sequence 162, US/18013523
Publication No. US20230303698A1
GENERAL INFORMATION
APPLICANT: HARBOUR BIOMED (SHANGHAI) CO., LTD
TITLE OF INVENTION: MULTISPECIFIC BINDING PROTEIN OF IMMUNE CELL ENGAGER, PREPARATION
TITLE OF INVENTION: THEREFOR AND APPLICATION THEREOF
FILE REFERENCE: P22416723US
CURRENT APPLICATION NUMBER: US/18/013,523
CURRENT FILING DATE: 2022-12-28
PRIOR APPLICATION NUMBER: CN202010630471.6
PRIOR FILING DATE: 2020-06-30
NUMBER OF SEQ ID NOS: 274
SEQ ID NO 162
LENGTH: 119
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: PR002067 VH
Query Match 79.0%; Score 98; Length 119;
Best Local Similarity 27.7%;
Matches 23; Conservative 0; Mismatches 0; Indels 60; Gaps 2;
Qy 1 GFTFSSY-------------------SGRGGS---------------------------- 13
||||||| ||||||
Db 26 GFTFSSYAMSWVRQAPGKGLEWVSAISGRGGSTFYADSVRGRFTISRDNSKNTLYLQMNS 85
Qy 14 -------------GTTGTTDVDY 23
||||||||||
Db 86 LRAEDTAMYYCVDGTTGTTDVDY 108
RESULT 2
US-18-013-523-193
(NOTE: this sequence has 2 duplicates in the database searched.
See complete list at the end of this report)
Sequence 193, US/18013523
Publication No. US20230303698A1
GENERAL INFORMATION
APPLICANT: HARBOUR BIOMED (SHANGHAI) CO., LTD
TITLE OF INVENTION: MULTISPECIFIC BINDING PROTEIN OF IMMUNE CELL ENGAGER, PREPARATION
TITLE OF INVENTION: THEREFOR AND APPLICATION THEREOF
FILE REFERENCE: P22416723US
CURRENT APPLICATION NUMBER: US/18/013,523
CURRENT FILING DATE: 2022-12-28
PRIOR APPLICATION NUMBER: CN202010630471.6
PRIOR FILING DATE: 2020-06-30
NUMBER OF SEQ ID NOS: 274
SEQ ID NO 193
LENGTH: 351
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: PR002067 HC
Query Match 79.0%; Score 98; Length 351;
Best Local Similarity 27.7%;
Matches 23; Conservative 0; Mismatches 0; Indels 60; Gaps 2;
Qy 1 GFTFSSY-------------------SGRGGS---------------------------- 13
||||||| ||||||
Db 26 GFTFSSYAMSWVRQAPGKGLEWVSAISGRGGSTFYADSVRGRFTISRDNSKNTLYLQMNS 85
Qy 14 -------------GTTGTTDVDY 23
||||||||||
Db 86 LRAEDTAMYYCVDGTTGTTDVDY 108
RESULT 3
US-18-013-523-274
Sequence 274, US/18013523
Publication No. US20230303698A1
GENERAL INFORMATION
APPLICANT: HARBOUR BIOMED (SHANGHAI) CO., LTD
TITLE OF INVENTION: MULTISPECIFIC BINDING PROTEIN OF IMMUNE CELL ENGAGER, PREPARATION
TITLE OF INVENTION: THEREFOR AND APPLICATION THEREOF
FILE REFERENCE: P22416723US
CURRENT APPLICATION NUMBER: US/18/013,523
CURRENT FILING DATE: 2022-12-28
PRIOR APPLICATION NUMBER: CN202010630471.6
PRIOR FILING DATE: 2020-06-30
NUMBER OF SEQ ID NOS: 274
SEQ ID NO 274
LENGTH: 566
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: PR007167 Chain
Query Match 79.0%; Score 98; Length 566;
Best Local Similarity 27.7%;
Matches 23; Conservative 0; Mismatches 0; Indels 60; Gaps 2;
Qy 1 GFTFSSY-------------------SGRGGS---------------------------- 13
||||||| ||||||
Db 241 GFTFSSYAMSWVRQAPGKGLEWVSAISGRGGSTFYADSVRGRFTISRDNSKNTLYLQMNS 300
Qy 14 -------------GTTGTTDVDY 23
||||||||||
Db 301 LRAEDTAMYYCVDGTTGTTDVDY 323
RESULT 4
US-18-013-523-273
Sequence 273, US/18013523
Publication No. US20230303698A1
GENERAL INFORMATION
APPLICANT: HARBOUR BIOMED (SHANGHAI) CO., LTD
TITLE OF INVENTION: MULTISPECIFIC BINDING PROTEIN OF IMMUNE CELL ENGAGER, PREPARATION
TITLE OF INVENTION: THEREFOR AND APPLICATION THEREOF
FILE REFERENCE: P22416723US
CURRENT APPLICATION NUMBER: US/18/013,523
CURRENT FILING DATE: 2022-12-28
PRIOR APPLICATION NUMBER: CN202010630471.6
PRIOR FILING DATE: 2020-06-30
NUMBER OF SEQ ID NOS: 274
SEQ ID NO 273
LENGTH: 573
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: PR007166 Chain
Query Match 79.0%; Score 98; Length 573;
Best Local Similarity 27.7%;
Matches 23; Conservative 0; Mismatches 0; Indels 60; Gaps 2;
Qy 1 GFTFSSY-------------------SGRGGS---------------------------- 13
||||||| ||||||
Db 248 GFTFSSYAMSWVRQAPGKGLEWVSAISGRGGSTFYADSVRGRFTISRDNSKNTLYLQMNS 307
Qy 14 -------------GTTGTTDVDY 23
||||||||||
Db 308 LRAEDTAMYYCVDGTTGTTDVDY 330
RESULT 5
US-18-013-523-238
(NOTE: this sequence has 2 duplicates in the database searched.
See complete list at the end of this report)
Sequence 238, US/18013523
Publication No. US20230303698A1
GENERAL INFORMATION
APPLICANT: HARBOUR BIOMED (SHANGHAI) CO., LTD
TITLE OF INVENTION: MULTISPECIFIC BINDING PROTEIN OF IMMUNE CELL ENGAGER, PREPARATION
TITLE OF INVENTION: THEREFOR AND APPLICATION THEREOF
FILE REFERENCE: P22416723US
CURRENT APPLICATION NUMBER: US/18/013,523
CURRENT FILING DATE: 2022-12-28
PRIOR APPLICATION NUMBER: CN202010630471.6
PRIOR FILING DATE: 2020-06-30
NUMBER OF SEQ ID NOS: 274
SEQ ID NO 238
LENGTH: 581
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: PR004277 Chain
Query Match 79.0%; Score 98; Length 581;
Best Local Similarity 27.7%;
Matches 23; Conservative 0; Mismatches 0; Indels 60; Gaps 2;
Qy 1 GFTFSSY-------------------SGRGGS---------------------------- 13
||||||| ||||||
Db 256 GFTFSSYAMSWVRQAPGKGLEWVSAISGRGGSTFYADSVRGRFTISRDNSKNTLYLQMNS 315
Qy 14 -------------GTTGTTDVDY 23
||||||||||
Db 316 LRAEDTAMYYCVDGTTGTTDVDY 338
RESULT 6
US-18-013-523-241
(NOTE: this sequence has 1 duplicate in the database searched.
See complete list at the end of this report)
Sequence 241, US/18013523
Publication No. US20230303698A1
GENERAL INFORMATION
APPLICANT: HARBOUR BIOMED (SHANGHAI) CO., LTD
TITLE OF INVENTION: MULTISPECIFIC BINDING PROTEIN OF IMMUNE CELL ENGAGER, PREPARATION
TITLE OF INVENTION: THEREFOR AND APPLICATION THEREOF
FILE REFERENCE: P22416723US
CURRENT APPLICATION NUMBER: US/18/013,523
CURRENT FILING DATE: 2022-12-28
PRIOR APPLICATION NUMBER: CN202010630471.6
PRIOR FILING DATE: 2020-06-30
NUMBER OF SEQ ID NOS: 274
SEQ ID NO 241
LENGTH: 583
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: PR004283 Chain
Query Match 79.0%; Score 98; Length 583;
Best Local Similarity 27.7%;
Matches 23; Conservative 0; Mismatches 0; Indels 60; Gaps 2;
Qy 1 GFTFSSY-------------------SGRGGS---------------------------- 13
||||||| ||||||
Db 490 GFTFSSYAMSWVRQAPGKGLEWVSAISGRGGSTFYADSVRGRFTISRDNSKNTLYLQMNS 549
Qy 14 -------------GTTGTTDVDY 23
||||||||||
Db 550 LRAEDTAMYYCVDGTTGTTDVDY 572
RESULT 7
US-18-013-523-233
(NOTE: this sequence has 1 duplicate in the database searched.
See complete list at the end of this report)
Sequence 233, US/18013523
Publication No. US20230303698A1
GENERAL INFORMATION
APPLICANT: HARBOUR BIOMED (SHANGHAI) CO., LTD
TITLE OF INVENTION: MULTISPECIFIC BINDING PROTEIN OF IMMUNE CELL ENGAGER, PREPARATION
TITLE OF INVENTION: THEREFOR AND APPLICATION THEREOF
FILE REFERENCE: P22416723US
CURRENT APPLICATION NUMBER: US/18/013,523
CURRENT FILING DATE: 2022-12-28
PRIOR APPLICATION NUMBER: CN202010630471.6
PRIOR FILING DATE: 2020-06-30
NUMBER OF SEQ ID NOS: 274
SEQ ID NO 233
LENGTH: 583
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: PR003789 Chain
Query Match 79.0%; Score 98; Length 583;
Best Local Similarity 27.7%;
Matches 23; Conservative 0; Mismatches 0; Indels 60; Gaps 2;
Qy 1 GFTFSSY-------------------SGRGGS---------------------------- 13
||||||| ||||||
Db 490 GFTFSSYAMSWVRQAPGKGLEWVSAISGRGGSTFYADSVRGRFTISRDNSKNTLYLQMNS 549
Qy 14 -------------GTTGTTDVDY 23
||||||||||
Db 550 LRAEDTAMYYCVDGTTGTTDVDY 572
RESULT 8
US-18-013-523-236
(NOTE: this sequence has 2 duplicates in the database searched.
See complete list at the end of this report)
Sequence 236, US/18013523
Publication No. US20230303698A1
GENERAL INFORMATION
APPLICANT: HARBOUR BIOMED (SHANGHAI) CO., LTD
TITLE OF INVENTION: MULTISPECIFIC BINDING PROTEIN OF IMMUNE CELL ENGAGER, PREPARATION
TITLE OF INVENTION: THEREFOR AND APPLICATION THEREOF
FILE REFERENCE: P22416723US
CURRENT APPLICATION NUMBER: US/18/013,523
CURRENT FILING DATE: 2022-12-28
PRIOR APPLICATION NUMBER: CN202010630471.6
PRIOR FILING DATE: 2020-06-30
NUMBER OF SEQ ID NOS: 274
SEQ ID NO 236
LENGTH: 584
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: PR004276 Chain
Query Match 79.0%; Score 98; Length 584;
Best Local Similarity 27.7%;
Matches 23; Conservative 0; Mismatches 0; Indels 60; Gaps 2;
Qy 1 GFTFSSY-------------------SGRGGS---------------------------- 13
||||||| ||||||
Db 491 GFTFSSYAMSWVRQAPGKGLEWVSAISGRGGSTFYADSVRGRFTISRDNSKNTLYLQMNS 550
Qy 14 -------------GTTGTTDVDY 23
||||||||||
Db 551 LRAEDTAMYYCVDGTTGTTDVDY 573
RESULT 9
US-18-013-523-243
(NOTE: this sequence has 1 duplicate in the database searched.
See complete list at the end of this report)
Sequence 243, US/18013523
Publication No. US20230303698A1
GENERAL INFORMATION
APPLICANT: HARBOUR BIOMED (SHANGHAI) CO., LTD
TITLE OF INVENTION: MULTISPECIFIC BINDING PROTEIN OF IMMUNE CELL ENGAGER, PREPARATION
TITLE OF INVENTION: THEREFOR AND APPLICATION THEREOF
FILE REFERENCE: P22416723US
CURRENT APPLICATION NUMBER: US/18/013,523
CURRENT FILING DATE: 2022-12-28
PRIOR APPLICATION NUMBER: CN202010630471.6
PRIOR FILING DATE: 2020-06-30
NUMBER OF SEQ ID NOS: 274
SEQ ID NO 243
LENGTH: 585
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: PR004285 Chain
Query Match 79.0%; Score 98; Length 585;
Best Local Similarity 27.7%;
Matches 23; Conservative 0; Mismatches 0; Indels 60; Gaps 2;
Qy 1 GFTFSSY-------------------SGRGGS---------------------------- 13
||||||| ||||||
Db 492 GFTFSSYAMSWVRQAPGKGLEWVSAISGRGGSTFYADSVRGRFTISRDNSKNTLYLQMNS 551
Qy 14 -------------GTTGTTDVDY 23
||||||||||
Db 552 LRAEDTAMYYCVDGTTGTTDVDY 574
RESULT 10
US-18-013-523-242
(NOTE: this sequence has 1 duplicate in the database searched.
See complete list at the end of this report)
Sequence 242, US/18013523
Publication No. US20230303698A1
GENERAL INFORMATION
APPLICANT: HARBOUR BIOMED (SHANGHAI) CO., LTD
TITLE OF INVENTION: MULTISPECIFIC BINDING PROTEIN OF IMMUNE CELL ENGAGER, PREPARATION
TITLE OF INVENTION: THEREFOR AND APPLICATION THEREOF
FILE REFERENCE: P22416723US
CURRENT APPLICATION NUMBER: US/18/013,523
CURRENT FILING DATE: 2022-12-28
PRIOR APPLICATION NUMBER: CN202010630471.6
PRIOR FILING DATE: 2020-06-30
NUMBER OF SEQ ID NOS: 274
SEQ ID NO 242
LENGTH: 587
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: PR004284 Chain
Query Match 79.0%; Score 98; Length 587;
Best Local Similarity 27.7%;
Matches 23; Conservative 0; Mismatches 0; Indels 60; Gaps 2;
Qy 1 GFTFSSY-------------------SGRGGS---------------------------- 13
||||||| ||||||
Db 494 GFTFSSYAMSWVRQAPGKGLEWVSAISGRGGSTFYADSVRGRFTISRDNSKNTLYLQMNS 553
Qy 14 -------------GTTGTTDVDY 23
||||||||||
Db 554 LRAEDTAMYYCVDGTTGTTDVDY 576
US-18-013-530-112
Filing date in PALM: 2022-12-28
Sequence 112, US/18013530
Publication No. US20230287143A1
GENERAL INFORMATION
APPLICANT: HARBOUR BIOMED (SHANGHAI) CO., LTD
TITLE OF INVENTION: BINDING PROTEIN IN FAB-HCAB STRUCTURE
FILE REFERENCE: P22416738US
CURRENT APPLICATION NUMBER: US/18/013,530
CURRENT FILING DATE: 2022-12-28
PRIOR APPLICATION NUMBER: CN202010618158.0
PRIOR FILING DATE: 2020-06-30
PRIOR APPLICATION NUMBER: CN202010630471.6
PRIOR FILING DATE: 2020-06-30
PRIOR APPLICATION NUMBER: CN202011423832.6
PRIOR FILING DATE: 2020-12-08
NUMBER OF SEQ ID NOS: 184
SEQ ID NO 112
LENGTH: 119
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: PR002067 VH
ALIGNMENT:
Query Match 79.0%; Score 98; Length 119;
Best Local Similarity 27.7%;
Matches 23; Conservative 0; Mismatches 0; Indels 60; Gaps 2;
Qy 1 GFTFSSY-------------------SGRGGS---------------------------- 13
||||||| ||||||
Db 26 GFTFSSYAMSWVRQAPGKGLEWVSAISGRGGSTFYADSVRGRFTISRDNSKNTLYLQMNS 85
Qy 14 -------------GTTGTTDVDY 23
||||||||||
Db 86 LRAEDTAMYYCVDGTTGTTDVDY 108
US-18-013-530-156
Filing date in PALM: 2022-12-28
Sequence 156, US/18013530
Publication No. US20230287143A1
GENERAL INFORMATION
APPLICANT: HARBOUR BIOMED (SHANGHAI) CO., LTD
TITLE OF INVENTION: BINDING PROTEIN IN FAB-HCAB STRUCTURE
FILE REFERENCE: P22416738US
CURRENT APPLICATION NUMBER: US/18/013,530
CURRENT FILING DATE: 2022-12-28
PRIOR APPLICATION NUMBER: CN202010618158.0
PRIOR FILING DATE: 2020-06-30
PRIOR APPLICATION NUMBER: CN202010630471.6
PRIOR FILING DATE: 2020-06-30
PRIOR APPLICATION NUMBER: CN202011423832.6
PRIOR FILING DATE: 2020-12-08
NUMBER OF SEQ ID NOS: 184
SEQ ID NO 156
LENGTH: 581
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: PR004277 Chain
ALIGNMENT:
Query Match 79.0%; Score 98; Length 581;
Best Local Similarity 27.7%;
Matches 23; Conservative 0; Mismatches 0; Indels 60; Gaps 2;
Qy 1 GFTFSSY-------------------SGRGGS---------------------------- 13
||||||| ||||||
Db 256 GFTFSSYAMSWVRQAPGKGLEWVSAISGRGGSTFYADSVRGRFTISRDNSKNTLYLQMNS 315
Qy 14 -------------GTTGTTDVDY 23
||||||||||
Db 316 LRAEDTAMYYCVDGTTGTTDVDY 338
Prosecution Insights