DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status
Claims 1-2 and 6-31 have been cancelled.
Claims 32-39 have been added.
Claims 3-5 and 32-39 are currently pending.
Claims 3-5 and 32-39 are being examined in this application.
Election/Restrictions
Applicant’s election without traverse of Group I invention (claims 3-5 and 32-39), and species of SEQ ID NOs: 1-8, 41 and 42 in the reply filed on 7/28/26 is acknowledged.
Priority
This application is filed under 35 U.S.C 371 of PCT/GB2022/051285 (filed on 05/20/2022), which claims foreign priority to UNITED KINGDOM 2107517.1 05/26/2021, and UNITED KINGDOM 2116709.3 11/19/2021.
Information Disclosure Statement
The IDS filed on 7/8/24, 1/13/25 and 7/28/26 have been considered. See the attached PTO 1449 forms.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. For example, on page 20, line 32. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant's cooperation is requested in correcting any errors of which applicant may become aware in the specification. MPEP 608.01.
Claim Rejections - 35 USC § 112
112(a) Rejection(s)
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.
Written Description Rejection
Claims 3-5 and 32-39 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.
The instant claims recite an antibody or fragment thereof that binds to CD1a wherein the antibodies have at least 80% identity with various SEQ ID NOs that are CDRs (claim 3), VH and VL sequences (claim 4), HC and LC sequences (claim 5).
To satisfy the written description requirement, applicants may convey reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention.
Applicants may show possession of an invention by disclosure of drawings or structural chemical formulas that are sufficiently detailed to show that applicant was in possession of the claimed invention as a whole. See, e.g., Vas-Cath, 935 F.2d at 1565, 19 USPQ2d at 1118.
The written description requirement of 35 U.SC. 112 exists independently of enablement requirement, and the requirement applies whether or not the case involves questions of priority. The requirement applies to all inventions and includes chemical inventions. The fact that the patent is directed to method entailing use of compounds, rather than to compounds per se, does not remove patentee’s obligation to provide a description of the compound sufficient to distinguish infringing methods from non-infringing methods. See Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 920-23, 69 USPQ 2d 1886, 1890-93 (Fed. Cir. 2004).
With regard to the description requirement, applicants’ attention is invited to consider the decision of the Court of Appeals for the Federal Circuit, which holds that a “written description of an invention involving a chemical genus, like a description of a chemical species, ‘requires a precise definition, such as by structure, formula [or] chemical name,’ of the claimed subject matter sufficient to distinguish it form other materials.” University of California v. Eli Lilly and Co., 43 USPQ2d 1398, 1405 (1997), quoting Fiers v. Revel, 25 USPQ2d 1601, 1606 (Fed. Cir. 1993) (bracketed material in original) [The claims at issue in University of California v. Eli Lilly defined the invention by function of the claimed DNA (encoding insulin)].
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species or by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. See Eli Lilly, 119 F. 3d at 1568, 43 USPQ2d at 1406.
Each of claims 3, 4 and 5 recites a genus of antibodies with numerous amino acid sequences. Claim 3 recites “…sequence having at least 80% identity…” of various SEQ ID NOs. Similarly, claims 4 and 5 recites at least 80% identity with the recited SEQ ID NOs. Neither the instant specification nor the claims have demonstrated common structure and/or function for the claimed genus of amino acid sequences that would have the same function of binding to CD1a as the antibodies of the recited sequences (100% matching). In addition, no representative numbers of species for each claimed genus of sequence are provided to show possession of the claimed genus of antibodies, fragments thereof that can bind to CD1a protein.
To provide evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof. (see MPEP 2163 II). In this case, the instant application did not provide the core sequences that would provide the CD1a binding capability. The only examples are the sequences with the 100% matching sequences to the recited SEQ ID NOs. The instant specification has not provided any examples where proteins that share 80% or more identity with the claimed SEQ ID NOs would still have the same binding affinity and function.
Therefore, applicants are not in possession of the entire claimed genus of antibody sequences.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Nakano et al
Claim 4 is rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Nakano et al (US7919086; 4/5/2011).
The instant claims recite “An antibody or antigen binding fragment thereof which binds to CD1a, comprising: … or b) a heavy chain variable region comprising SEQ ID NO: 7; and/or a light chain variable region comprising SEQ ID NO: 8 or sequences having at least 80% identity thereto…”
Nakano et al, throughout the patent, teach various antibodies with different sequences (e.g. Abstract). The reference teaches SEQ ID NO: 28 that is the VH region of the M6B1 antibody (e.g. col.8, ll. 60+), which is 88.8% matching to the instant SEQ ID NO: 7.
Kawada et al
Claims 4 and 36 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Kawada et al (US9416189; 8/16/2016).
Kawada et al, throughout the patent, teach various antibodies with different sequences (e.g. Abstract).
For claim 4, the reference teaches SEQ ID NO: 5 that is the VL region of an antibody (e.g. claims 1, 5), which is 98% matching to the instant SEQ ID NO: 8.
For claim 36, the reference teaches antibody fragments including scFv, diabody, Fv, etc. (e.g. col.14-15 bridging para).
Chen et al
Claim 5 is rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Chen et al (WO2018133842; 7/26/2018; filed n 1/19/2018 or earlier; Machine Translation is attached).
The instant claims recite “An antibody or antigen binding fragment thereof which binds to CD1a, comprising: … or b) a heavy chain comprising or consisting of SEQ ID NO: 41; and/or a light chain comprising or consisting of SEQ ID NO: 42 or sequences having at least 80% identity thereto…”
Chen et al, throughout the publication, teach various antibodies with different sequences (e.g. Abstract). The reference teaches SEQ ID NO: 3 that is the VH region of an antibody (e.g. p.2, ll. 1+; claims 1-2), which is 94.5% matching to the instant SEQ ID NO: 41.
Walsh et al
Claim 5 is rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Walsh et al (US 10151754; 12/11/2018).
Walsh et al, throughout the reference, teach antibodies with various sequences (e.g. Abstract). The reference teaches a VL region of an antibody with SEQ ID NO: 11 (e.g. col.21, ll 17+; col.53; claim 1), which is 93.1% matching to the instant SEQ ID NO: 42.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Kawada and Desjarlais
Claims 4, 36, 37-39 are rejected under 35 U.S.C. 103(a) as being unpatentable over Kawada et al (US9416189; 8/16/2016), in view of Desjarlais et al (US20070275460; 11/29/2007; cited in IDS).
Kawada et al, throughout the patent, teach various antibodies with different sequences, as discussed above.
Kawada does not explicitly teach antibody modification for stabilization as recited in claim 37, the antibody comprise human IgG1 or IgG4 Fc domain of claim 38, and the antibody is bispecific or multispecific of claim 39.
However, Desjarlais et al., throughout the reference, teach various antibodies and modification thereof (e.g. Abstract). The reference teaches using human IgG1 Fc fragment since it will provide greater binding affinity (e.g. [0135]). The reference also teaches stabilizing the antibody through disulphide modification (e.g. [0099]). The reference also teaches the antibodies can be various form including bispecific or multispecific antibodies depending on the application of the antibody such as binding to two specific antigens (e.g. [0097]; [0100]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to generate antibodies with appropriate modification including disulphide modification for the purpose of increase stability of the antibodies as taught by Desjarlais, because modifying antibodies to improve stability is routine and known in the art as shown in Desjarlais.
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to generate antibodies with human IgG1 Fc fragment to improve the antibody binding affinition as taught by Desjarlais, because modifying antibodies constant region with human IgG1 Fc fragment is routine and known in the art as shown in Desjarlais.
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to generate bispecific or multispecific antibodies for various applications as taught by Desjarlais.
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.
‘390 application
Claims 3-5 and 32-39 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of copending Application No. 19221390 (abbreviated as ‘390 application) in view of Kawada et al (US9416189; 8/16/2016), Walsh et al (US 10151754; 12/11/2018), and Desjarlais et al (US20070275460; 11/29/2007; cited in IDS).
The ‘390 application claims the following:
An antibody or antigen binding fragment thereofthat binds to cluster of differentiation la (CDla), comprising or consisting of:a) a heavy chain variable region comprising:a CDR1 of SEQ ID NO: 91,a CDR2 of SEQ ID NO: 92, anda CDR3 of SEQ ID NO: 93,or sequences having at least 80%, 90%, 95%, 98%, 99% or 100% identity thereto; and/or b) a light chain variable region comprising:a CDR1 of SEQ ID NO: 94,a CDR2 of SEQ ID NO: 95, anda CDR3 of SEQ ID NO: 96 or sequences having at least 80%, 90%, 95%,98%, 99% or 100% identity thereto.
10. A composition comprising [[the]]an antibody or antigen binding fragment thereof of claim l, wherein the composition further comprises a second antibody or antigen binding fragments thereof, wherein the second antibody or antigen binding fragment comprises: a) a heavy chain variable region comprising: a CDR1 of SEQ ID NO: 1,a CDR2 of SEQ ID NO: 2, anda CDR3 of SEQ ID NO: 3,or sequences having at least 80%, 90%, 95%, 98%, 99% or 100% identity thereto; and/or a light chain variable region comprising:a CDR1 of SEQ ID NO: 4,a CDR2 of SEQ ID NO: 5, anda CDR3 of SEQ ID NO: 6,or sequences having at least 80%, 90%, 95%,98%, 99% or 100% identity thereto…
The ’390 application does not explicitly the specific sequences as recited in claims 4 and 5, the antibody modification for stabilization as recited in claim 37, the antibody comprise human IgG1 or IgG4 Fc domain of claim 38, and the antibody is bispecific or multispecific of claim 39.
However, Kawada et al, throughout the patent, teach various antibodies with different sequences (e.g. Abstract). Kawada et al, throughout the patent, teach various antibodies with different sequences (e.g. Abstract). The reference teaches SEQ ID NO: 5 that is the VL region of an antibody (e.g. claims 1, 5), which is 98% matching to the instant SEQ ID NO: 8. The reference teaches antibody fragments including scFv, diabody, Fv, etc. (e.g. col.14-15 bridging para).
Walsh et al, throughout the reference, teach antibodies with various sequences (e.g. Abstract). The reference teaches a VL region of an antibody with SEQ ID NO: 11 (e.g. col.21, ll 17+; col.53; claim 1), which is 93.1% matching to the instant SEQ ID NO: 42.
Desjarlais et al., throughout the reference, teach various antibodies and modification thereof (e.g. Abstract). The reference teaches using human IgG1 Fc fragment since it will provide greater binding affinity (e.g. [0135]). The reference also teaches stabilizing the antibody through disulphide modification (e.g. [0099]). The reference also teaches the antibodies can be various form including bispecific or multispecific antibodies depending on the application of the antibody such as binding to two specific antigens (e.g. [0097]; [0100]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to generate antibodies with various sequences for the VH/VL and HC/LC fragments as taught by Kawada and Walsh, because these sequences are known in the art. It would have been prima facie obvious to substitute one VH/VL sequence (or HC/LC) for another to achieve the predictable results of generating desired antibodies.
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to generate antibodies with appropriate modification including disulphide modification for the purpose of increase stability of the antibodies as taught by Desjarlais, because modifying antibodies to improve stability is routine and known in the art as shown in Desjarlais.
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to generate antibodies with human IgG1 Fc fragment to improve the antibody binding affinition as taught by Desjarlais, because modifying antibodies constant region with human IgG1 Fc fragment is routine and known in the art as shown in Desjarlais.
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to generate bispecific or multispecific antibodies for various applications as taught by Desjarlais.
This is a provisional nonstatutory double patenting rejection.
‘384 application
Claims 3-5 and 32-39 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of copending Application No. 19221384 (abbreviated as ‘384 application) in view of Kawada et al (US9416189; 8/16/2016), Walsh et al (US 10151754; 12/11/2018), and Desjarlais et al (US20070275460; 11/29/2007; cited in IDS).
The ‘384 application claims the following:
An antibody or antigen binding fragment thereof that binds to cluster of differentiation la (CDla), wherein the antibody or antigen binding fragment thereof is chimeric, and wherein the antibody or antigen binding fragment thereof comprises: a) a heavy chain variable region comprising:a CDR1 of SEQ ID NO: 33,a CDR2 of SEQ ID NO: 34, anda CDR3 of SEQ ID NO: 35,or sequences having at least 80%, 90%,95%,98%,99%or100% identity thereto,and/or a light chain variable region comprising:a CDR1 of SEQ ID NO: 36,a CDR2 of SEQ ID NO: 37, anda CDR3 of SEQ ID NO: 38,or sequences having at least 80%, 90%. 95%,98%,99% or 100%, identity thereto; or b) a heavy chain variable region comprising:a CDR1 of SEQ ID NO: 1,a CDR2 of SEQ ID NO: 2, anda CDR3 of SEQ ID NO: 3,or sequences having at least 80%, 90%, 95%, 98%, 99% or 100% identity thereto…
An antibody or antigen binding fragment thereofthat binds to CDla, wherein the antibody or antigen binding fragment thereof is humanized, and wherein the a humanised antibody or antigen binding fragment thereof comprisescomprising or consisting of:(a) [[ ]]a heavy chain variable region comprising: a CDR1 of SEQ ID NO: 33,a CDR2 of SEQ ID NO: 34, anda CDR3 of SEQ ID NO: 35,or sequences having at least 80%, 90%, 95%, 98%, 99% or 100% identity thereto;and/or a light chain variable region comprising:a CDR1 of SEQ ID NO: 36, SEQ ID NO: 135, SEQ ID NO: 136…
The ’384 application does not explicitly the specific sequences as recited in claims 4 and 5, the antibody modification for stabilization as recited in claim 37, the antibody comprise human IgG1 or IgG4 Fc domain of claim 38, and the antibody is bispecific or multispecific of claim 39.
However, Kawada et al, throughout the patent, teach various antibodies with different sequences (e.g. Abstract). Kawada et al, throughout the patent, teach various antibodies with different sequences (e.g. Abstract). The reference teaches SEQ ID NO: 5 that is the VL region of an antibody (e.g. claims 1, 5), which is 98% matching to the instant SEQ ID NO: 8. The reference teaches antibody fragments including scFv, diabody, Fv, etc. (e.g. col.14-15 bridging para).
Walsh et al, throughout the reference, teach antibodies with various sequences (e.g. Abstract). The reference teaches a VL region of an antibody with SEQ ID NO: 11 (e.g. col.21, ll 17+; col.53; claim 1), which is 93.1% matching to the instant SEQ ID NO: 42.
Desjarlais et al., throughout the reference, teach various antibodies and modification thereof (e.g. Abstract). The reference teaches using human IgG1 Fc fragment since it will provide greater binding affinity (e.g. [0135]). The reference also teaches stabilizing the antibody through disulphide modification (e.g. [0099]). The reference also teaches the antibodies can be various form including bispecific or multispecific antibodies depending on the application of the antibody such as binding to two specific antigens (e.g. [0097]; [0100]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to generate antibodies with various sequences for the VH/VL and HC/LC fragments as taught by Kawada and Walsh, because these sequences are known in the art. It would have been prima facie obvious to substitute one VH/VL sequence (or HC/LC) for another to achieve the predictable results of generating desired antibodies.
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to generate antibodies with appropriate modification including disulphide modification for the purpose of increase stability of the antibodies as taught by Desjarlais, because modifying antibodies to improve stability is routine and known in the art as shown in Desjarlais.
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to generate antibodies with human IgG1 Fc fragment to improve the antibody binding affinition as taught by Desjarlais, because modifying antibodies constant region with human IgG1 Fc fragment is routine and known in the art as shown in Desjarlais.
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to generate bispecific or multispecific antibodies for various applications as taught by Desjarlais.
This is a provisional nonstatutory double patenting rejection.
Conclusion and Correspondence
No claims are allowed.
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/SUE X LIU/Supervisory Patent Examiner, Art Unit 1616
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