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
The preliminary amendment filed 08/15/2024 is acknowledged. Claims 2, 3, 5-7, 10, 12, 14-16, 19, 22-24, 26, 27, 30, 32-34, 38-46, 48, 49, 51, and 52 are cancelled. Claims 1, 4, 8, 9, 11, 13, 17, 18, 20, 21, 25, 28, 29, 31, 35, 36, and 37 are amended. Claim 53 is new. Claims 1, 4, 8, 9, 11, 13, 17, 18, 20, 21, 25, 28, 29, 31, 35, 36, 37, 50, and 53 are pending and under examination.
Information Disclosure Statement
The information disclosure statements filed 08/12/24, 01/09/25, and 04/24/25 fail to comply with 37 CFR 1.98(a)(1), which requires the following: (1) a list of all patents, publications, applications, or other information submitted for consideration by the Office; (2) U.S. patents and U.S. patent application publications listed in a section separately from citations of other documents; (3) the application number of the application in which the information disclosure statement is being submitted on each page of the list; (4) a column that provides a blank space next to each document to be considered, for the examiner’s initials; and (5) a heading that clearly indicates that the list is an information disclosure statement. The information disclosure statement has been placed in the application file, but the information referred to therein has not been considered.
The listing of references in the PCT international search report is not considered to be an information disclosure statement (IDS) complying with 37 CFR 1.98. 37 CFR 1.98(a)(2) requires a legible copy of: (1) each foreign patent; (2) each publication or that portion which caused it to be listed; (3) for each cited pending U.S. application, the application specification including claims, and any drawing of the application, or that portion of the application which caused it to be listed including any claims directed to that portion, unless the cited pending U.S. application is stored in the Image File Wrapper (IFW) system; and (4) all other information, or that portion which caused it to be listed. In addition, each IDS must include a list of all patents, publications, applications, or other information submitted for consideration by the Office (see 37 CFR 1.98(a)(1) and (b)), and MPEP § 609.04(a), subsection I. states, “the list ... must be submitted on a separate paper.” Therefore, the references cited in the international search report have not been considered. Applicant is advised that the date of submission of any item of information in the international search report will be the date of submission of the IDS for purposes of determining compliance with the requirements for the IDS with 37 CFR 1.97, including all timing statement requirements of 37 CFR 1.97(e). See MPEP § 609.05(a).
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, 4, 8, 9, 11, 13, 17, 18, 20, 21, 25, 28, 29, 31, 35, 36, 37, 50, and 53 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 written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see MPEP 2163(II)(3)(a)(i)(A), reduction to drawings MPEP 2163(II)(3)(a)(i)(B), 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 MPEP 2163(II)(3)(a)(i)(C).
Claims 1 and 50 recite several antibodies comprising alternative CDR sequences, which encompasses a genus of proteins. The instant specification discloses that instant SEQ ID NOs: 42, 44, 46, 56, 58, and 60 are defined by KABAT numbering while instant SEQ ID NOs:36, 38, 40, 50, 52, and 54 are defined by IMGT numbering. In cross referencing these sequences with the heavy and light chains of instant SEQ ID NOs: 62 and 64, it is clear that these sequences identify alternative descriptions of the same binding regions; that is, they are all present within SEQ ID NOs: 62 and 64 (amlitelimab) but they comprise different collections of amino acids with only some overlap. Protein chemistry is unpredictable; even a single amino acid substitution can abolish protein activity [see Rudikoff et al., abstract, IDS 08/12/24 Citation #607], as is the case with alternative CDR combinations. The fact that the specification discloses each CDR under multiple numbering conventions does not necessarily demonstrate possession of every antibody encompassed by the claim or that those CDR segments may be independently combined with one another while retaining OX40L binding. As such, the specification fails to provide a representative number of species within the recited genus, adequate structure-function correlation, or other identifying characteristics of the genus as a whole, and accordingly, the disclosure does not reasonably convey possession of the full scope of CDR combinations. Claims 4, 8, 9, 11, 13, 17, 18, 20, 21, 25, 28, 29, 31, 36, 37, 50, and 53 are included for requiring the composition of claim 1 without correcting the lack of written description.
Claims 1, 4, and 35 recite heavy and light chain variable region sequences of “at least 80% identity,” which encompasses a genus of proteins. The recited language includes possible modifications to CDRs, which are critical to protein binding. As discussed above, protein chemistry is unpredictable, and the art recognizes that even a single amino acid substitution can abolish protein activity. As such, the specification fails to provide a representative number of species within the recited genus, adequate structure-function correlation, or other identifying characteristics of the genus as a whole, and accordingly, the disclosure does not reasonably convey possession of the full scope of possible CDR combinations and amino acid modifications. Claims 8, 9, 11, 13, 17, 18, 20, 21, 25, 28, 29, 31, 36, 37, 47, and 53 are included for requiring the composition of claim 1 without correcting the lack of written description.
Claim 36 recites amlitelimab or “a variant thereof,” which encompasses a genus of proteins. The specification defines a variant as “any polypeptide that retains at least some biological activity referred to herein” [see p. 29, par. 4] and provides the exemplified biological activity of “antigen binding.” All therapeutic antibodies would be expected to display antigen binding properties, and even limiting the scope further to just OX40L-binding antibodies still encompasses a large genus of proteins. However, as discussed above, the specification only demonstrates amlitelimab, comprising a specific variable heavy and variable light chain. The specification fails to provide a representative number of species within the recited genus, adequate structure-function correlation, or other identifying characteristics of the genus as a whole, and accordingly, the disclosure does not reasonably convey possession of the full scope of possible amino acid modifications and subsequent CDR combinations.
Therefore, claims 1, 4, 8, 9, 11, 13, 17, 18, 20, 21, 25, 28, 29, 31, 35, 36, 37, 50, and 53 are rejected for lack of written description.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 4, 8, 11, 18, 25, 28, 29, 37, 47, 50, 53 are rejected under 35 U.S.C. 102a1 as being anticipated by Bland-Ward et al, (US Patent 11779604, IDS 08/12/24 Citation #134).
Claims 1, 4, 8, 11, 18, and 50 are drawn to an aqueous pharmaceutical formulation, claims 25, 28, and 29 are drawn to a container comprising an aqueous pharmaceutical formulation, claim 37 is drawn to a kit, and claims 47 and 53 are drawn to a method of treating a disease.
Bland-Ward et al. discloses an anti-OX40 ligand (also known as OX40L or hOX40L) antagonist antibody comprising SEQ ID NO: 62 and 64 [see col. 37, par. 3], which correspond to instant SEQ ID NOs: 62 and 64 [see sequence alignment below] (instant claims 1, 4, and 50).
SEQ ID NO 62 aligned to instant SEQ ID NO: 62
Query Match 100.0%; Score 2412; DB 1; Length 454;
Best Local Similarity 100.0%;
Matches 454; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 EVQLVESGGGLVQPGGSLRLSCAASGFTFSNYAMNWVRQAPGKGLEWVSTISGSGGATRY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 EVQLVESGGGLVQPGGSLRLSCAASGFTFSNYAMNWVRQAPGKGLEWVSTISGSGGATRY 60
Qy 61 ADSVKGRFTISRDNSRNTVYLQMNSLRVEDTAVFYCTKDRLIMATVRGPYYYGMDVWGQG 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 ADSVKGRFTISRDNSRNTVYLQMNSLRVEDTAVFYCTKDRLIMATVRGPYYYGMDVWGQG 120
Qy 121 TTVTVSSASTKGPSVFPLAPCSRSTSESTAALGCLVKDYFPEPVTVSWNSGALTSGVHTF 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 TTVTVSSASTKGPSVFPLAPCSRSTSESTAALGCLVKDYFPEPVTVSWNSGALTSGVHTF 180
Qy 181 PAVLQSSGLYSLSSVVTVPSSSLGTKTYTCNVDHKPSNTKVDKRVESKYGPPCPPCPAPE 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 PAVLQSSGLYSLSSVVTVPSSSLGTKTYTCNVDHKPSNTKVDKRVESKYGPPCPPCPAPE 240
Qy 241 FEGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSQEDPEVQFNWYVDGVEVHNAKTKPRE 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 FEGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSQEDPEVQFNWYVDGVEVHNAKTKPRE 300
Qy 301 EQFNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKGLPSSIEKTISKAKGQPREPQVYTLPP 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 EQFNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKGLPSSIEKTISKAKGQPREPQVYTLPP 360
Qy 361 SQEEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSRLTVD 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 SQEEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSRLTVD 420
Qy 421 KSRWQEGNVFSCSVMHEALHNHYTQKSLSLSLGK 454
||||||||||||||||||||||||||||||||||
Db 421 KSRWQEGNVFSCSVMHEALHNHYTQKSLSLSLGK 454
SEQ ID NO 64 aligned to instant SEQ ID NO: 64
Query Match 100.0%; Score 1101; DB 1; Length 214;
Best Local Similarity 100.0%;
Matches 214; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 DIQMTQSPSSLSASVGDRVTITCRASQSISSYLNWYQQKPGKAPNLLIYAASSLQSGVPS 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 DIQMTQSPSSLSASVGDRVTITCRASQSISSYLNWYQQKPGKAPNLLIYAASSLQSGVPS 60
Qy 61 RFSGSGSETDFTLTISSLQPEDFATYYCQQSHSVSFTFGPGTKVDIKRTVAAPSVFIFPP 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 RFSGSGSETDFTLTISSLQPEDFATYYCQQSHSVSFTFGPGTKVDIKRTVAAPSVFIFPP 120
Qy 121 SDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLT 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 SDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLT 180
Qy 181 LSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC 214
||||||||||||||||||||||||||||||||||
Db 181 LSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC 214
It is noted that instant SEQ ID NOs: 62 and 64 comprise all of the disclosed sequences of instant claim 1. Bland-Ward et al. discloses KY1005 [see col. 235, lines 20-23] also known as amlitelimab [as evidenced by instant specification par. 356] (instant claim 36). Bland-Ward et al. teaches that suitable therapeutic formulations containing an antibody of the disclosure can be in the form of a lyophilized formulation or an aqueous solution [see col. 176, par. 7] (instant claims 1 and 50), that the formulation may comprise the stabilizer sucrose (instant claims 1, 11, and 50), the chelating agent ethylenediaminetetraacetic acid (EDTA) (instant claims 1, 18, and 50), surfactants such as TWEEN™ (a brand name for a family of polysorbate based surfactants) (instant claims 1 and 50), the buffer histidine (instant claims 1 and 50) [see col. 177, par. 1], and that lyophilized powders can be mixed with sterile water for reconstitution of the powder or as a carrier for parenteral use [see col. 185, par. 7] (instant claims 8, 20, and 31). The solutions may be formulated at a pH of about 5-7 [see col. 186, par. 3] (instant claims 1 and 50). Bland-Ward et al. teaches that the compositions can be administered to a human [see col. 180, par. 5] (instant claims 1, 8, 25, and 50) and that unit dose parenteral preparations can be packaged in a vial [see col. 185, par. 1] or syringe [see col. 180, par. 5] (instant claims 25, 28, 29, 31, 36) as part of a kit [see col. 204, par. 4] (instant claim 37). Bland-Ward et al. teaches the antibody comprising SEQ ID NOs: 62 and 64 [see col. 37, par. 3 for the specific embodiment] can be used to treat or prevent an inflammatory or autoimmune disease [see col. 37, par. 4] such as asthma [see col. 16, par. 8], comprising administering the anti-OX40L antibody [see col. 138, par. 7] (instant claims 47 and 53).
Therefore, claims 1, 4, 8, 11, 18, 25, 28, 29, 37, 47, 50, 53 are rejected under 35 U.S.C. 102a1.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 9, 13, 17, 20, 21, 31, 35, and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Bland-Ward et al., (US Patent 11779604, IDS 08/12/24 Citation #134), in view of Desai et al., and in further view of Strickley et al. (IDS 01/09/25 Citation #15).
Claims 9, 13, 17, 20, and 21 are drawn to an aqueous pharmaceutical formulation and claims 31, 35, and 36 are drawn to a container comprising an aqueous pharmaceutical formulation.
The teachings of Bland-Ward et al. are discussed above.
Bland-Ward et al. does not teach or suggest specific concentrations of the components within the composition.
Desai et al. teaches a lyophilized antibody formulation, wherein reconstitution generates an aqueous pharmaceutical formulation comprising about 10-50 mg/mL of an anti-LAG3 antibody (instant claims 1, 20, 31, and 50), about 50-80 mg/mL sucrose (which encompasses 220 mM), about 10-50 mM histidine buffer at pH 5.0-6.0 (instant claims 17, 20, and 31), about 0.2-0.5 mg/mL polysorbate 80 (instant claims 13, 20, and 31), and about 1-30 uM EDTA (instant claims 21 and 31) [see p. 34, embodiment 10]. Similar compositions can be used for antibody concentrations of 10-100 mg/mL [see p. 33, embodiment 9] (instant claim 9). Desai et al. teaches that the reconstituted formulation is suitable for parenteral administration [see p. 12, par. 4], that sterile water is a suitable liquid for reconstitution [see p. 47, par. 2], and that reconstitution may occur in the container (which includes glass vials) in which the antibody is stored to avoid transfer [see p. 46, par. 3]. The pharmaceutical formulation may be administered in a syringe or autoinjector filled with the liquid formulation [see p. 51, par. 5] (instant claims 31, 35, and 36).
Strickley et al. as a whole teaches that the claimed components were conventional, routinely optimized, and employed in commercial therapeutic antibody formulations to generate solutions suitable for stability and parenteral administration.
It would have been obvious to combine these teachings and optimize the concentrations and pH of the formulation taught by Bland-Ward et al. using the teachings of Desai et al. because both teachings are directed to aqueous pharmaceutical formulations of therapeutic antibodies, both employ the same conventional formulation components, and Strickley et al. teaches that such components were routinely optimized to obtain a stable aqueous antibody formulations suitable for administration. There would have been a reasonable expectation of success because Desai et al. demonstrates that these excipients can be combined in aqueous antibody formulations and additionally provides specific concentrations and values that are in line with those disclosed by Strickley et al. Similarly, it would have been obvious to administer the modified composition to a human for the treatment of an autoimmune or inflammatory disease, such as asthma, as Bland-Ward et al. teaches that the antibody, including amlitelimab, can be administered for the treatment of such diseases and the formula comprising the antibody would have been suitable for parenteral administration to a human. Finally, it would have been obvious to generate the antibody in a pre-filled syringe or autoinjector as the art teaches that such formulations can be stored in those forms and these containers provide a routine means of self-administration.
Therefore, claims 9, 13, 17, 20, 21, 31, 35, and 36 are rejected under 35 U.S.C. 103.
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, 4, 8, 9, 11, 13, 17, 18, 20, 21, 25, 28, 29, 31, 35, 36, 37, and 50 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 3 of U.S. Patent No. 11779604 (herein referred to as “Bland-Ward et al.”) in view of Desai et al, and in further view of Strickley et al. (IDS 01/09/25 Citation #15).
Bland-Ward et al. teaches a method for increasing the ratio of Treg:Tconv cells in a patient with an antibody that binds to human OX40L comprising the VH and VL chain sequences of SEQ ID NOs: 34 and 48 [see claims 1 and 3]. SEQ ID NOs: 34 and 48 correspond to instant SEQ ID NOs: 34 and 48 [see alignment below] (instant claims 1, 4, 35, 36, and 50).
SEQ ID NO 34 aligned to instant SEQ ID NO: 34
Query Match 100.0%; Score 665; DB 1; Length 127;
Best Local Similarity 100.0%;
Matches 127; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 EVQLVESGGGLVQPGGSLRLSCAASGFTFSNYAMNWVRQAPGKGLEWVSTISGSGGATRY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 EVQLVESGGGLVQPGGSLRLSCAASGFTFSNYAMNWVRQAPGKGLEWVSTISGSGGATRY 60
Qy 61 ADSVKGRFTISRDNSRNTVYLQMNSLRVEDTAVFYCTKDRLIMATVRGPYYYGMDVWGQG 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 ADSVKGRFTISRDNSRNTVYLQMNSLRVEDTAVFYCTKDRLIMATVRGPYYYGMDVWGQG 120
Qy 121 TTVTVSS 127
|||||||
Db 121 TTVTVSS 127
SEQ ID NO 48 aligned to instant SEQ ID NO: 48
Query Match 100.0%; Score 548; DB 1; Length 107;
Best Local Similarity 100.0%;
Matches 107; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 DIQMTQSPSSLSASVGDRVTITCRASQSISSYLNWYQQKPGKAPNLLIYAASSLQSGVPS 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 DIQMTQSPSSLSASVGDRVTITCRASQSISSYLNWYQQKPGKAPNLLIYAASSLQSGVPS 60
Qy 61 RFSGSGSETDFTLTISSLQPEDFATYYCQQSHSVSFTFGPGTKVDIK 107
|||||||||||||||||||||||||||||||||||||||||||||||
Db 61 RFSGSGSETDFTLTISSLQPEDFATYYCQQSHSVSFTFGPGTKVDIK 107
Bland-Ward et al. does not teach or suggest a suitable pharmaceutical composition comprising said antibody.
Desai et al. teaches a lyophilized antibody formulation, wherein reconstitution generates and aqueous pharmaceutical formulation comprising about 10-50 mg/mL of antibody (instant claim 1, 20, 31, and 50), about 50-80 mg/mL sucrose (which encompasses 220 mM) (instant claims 1, 11, 20, 31, and 50), about 10-50 mM histidine buffer at pH 5.0-6.0 (instant claims 1, 17, 20, 31, and 50), about 0.2-0.5 mg/mL polysorbate 80 (instant claims 1, 13, 20, 31, and 50), and about 1-30 uM EDTA (instant claims 1, 18, 21, 31, and 50) [see p. 34, embodiment 10]. Similar compositions can be used for antibody concentrations of 10-100 mg/mL [see p. 33, embodiment 9] (instant claim 9). Desai et al. teaches that the reconstituted formulation is suitable for parenteral administration [see p. 12, par. 4] (instant claims 1 and 8), that sterile water is a suitable liquid for reconstitution (thereby making an aqueous formulation) [see p. 47, par. 2] (instant claims 1, 20, 31, and 50), and that reconstitution may occur in the container (which includes glass vials) (instant claims 28 and 29) in which the antibody is stored to avoid transfer [see p. 46, par. 3]. The pharmaceutical formulation may be administered in a syringe or autoinjector filled with the liquid formulation [see p. 51, par. 5] (instant claims 31, 35, and 36) parenterally to a human subject [see p. 9, par. 4] (instant claims 8, 25, and 50).
Strickley et al. as a whole teaches that the claimed components were conventional, routinely optimized, and employed in a wide variety of commercial therapeutic antibody formulations to generate solutions suitable for stability and parenteral administration.
It would have been obvious to combine these teachings optimize the concentrations and pH of the formulation taught by Bland-Ward et al. using the teachings of Desai et al. because both teachings are directed to aqueous pharmaceutical formulations of therapeutic antibodies, both employ the same conventional formulation components, and Strickley et al. teaches that such components were routinely optimized to obtain a stable aqueous antibody formulations suitable for administration. There would have been a reasonable expectation of success because Desai et al. demonstrates that these excipients can be combined in aqueous antibody formulations and additionally provides specific concentrations and values that are similar to those disclosed by Strickley et al. Furthermore, it would have been obvious to generate the antibody in a pre-filled syringe or autoinjector as the art teaches that such formulations can be stored in those forms and these containers provide a routine means of self-administration, and it would have been obvious to generate a kit comprising the container comprising the pharmaceutical composition as kits are a well-established and routine method of commercial distribution (instant claim 37).
Therefore, claims 1, 4, 8, 9, 11, 13, 17, 18, 20, 21, 25, 28, 29, 31, 35, 36, 37, and 50 are rejected on the ground of non-statutory double patenting.
Claims 1, 4, 8, 9, 11, 13, 17, 18, 20, 21, 25, 28, 29, 31, 35, 36, 37, 47, and 50 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 3 of U.S. Patent No. 11779604 (herein referred to as “Bland-Ward et al.”) in view of Desai et al, and in further view of Strickley et al. (IDS 01/09/25 Citation #15) and Elhai et al.
Bland-Ward et al. teaches a method for increasing the ratio of regulatory T cells to conventional effector T cells (Treg:Tconv) in a patient with an antibody that binds to human OX40L, said antibody comprising the VH and VL chain sequences of SEQ ID NOs: 34 and 48 [see claims 1 and 3]. SEQ ID NOs: 34 and 38 correspond to instant SEQ ID NOs: 34 and 48 [see alignment above] (instant claims 1, 4, 35, 36, and 50).
Bland-Ward et al. does not teach or suggest a suitable pharmaceutical composition comprising said antibody or method of treating an inflammatory or autoimmune diseases.
Desai et al. teaches a lyophilized antibody formulation, wherein reconstitution generates and aqueous pharmaceutical formulation comprising about 10-50 mg/mL of antibody (instant claim 1, 20, 31, and 50), about 50-80 mg/mL sucrose (which encompasses 220 mM) (instant claims 1, 11, 20, 31, and 50), about 10-50 mM histidine buffer at pH 5.0-6.0 (instant claims 1, 17, 20, 31, and 50), about 0.2-0.5 mg/mL polysorbate 80 (instant claims 1, 13, 20, 31, and 50), and about 1-30 uM EDTA (instant claims 1, 18, 21, 31, and 50) [see p. 34, embodiment 10]. Similar compositions can be used for antibody concentrations of 10-100 mg/mL [see p. 33, embodiment 9] (instant claim 9). Desai et al. teaches that the reconstituted formulation is suitable for parenteral administration [see p. 12, par. 4] (instant claims 1 and 8), that sterile water is a suitable liquid for reconstitution (thereby making an aqueous formulation) [see p. 47, par. 2] (instant claims 1, 20, 31, and 50), and that reconstitution may occur in the container (which includes glass vials) (instant claims 28 and 29) in which the antibody is stored to avoid transfer [see p. 46, par. 3]. The pharmaceutical formulation may be administered in a syringe or autoinjector filled with the liquid formulation [see p. 51, par. 5] (instant claims 31, 35, and 36) parenterally to a human subject [see p. 9, par. 4] (instant claims 8, 25, and 50).
Strickley et al. as a whole teaches that the claimed components were conventional, routinely optimized, and employed in a wide variety of commercial therapeutic antibody formulations to generate solutions suitable for stability and parenteral administration.
Elhai et al. teaches that OX40L induces inflammation, that antibodies against OX40L are protective against inflammation driven damage in autoimmune disorders, and that OX40L antibodies are well tolerated in humans [see discussion, p. E3905 col. 2, par. 3; p. E3907, col. 1, par. 3; and p. E3907, col. 2, par. 3 through E3908, col. 1, par. 1].
It would have been obvious to combine these teachings optimize the concentrations and pH of the formulation taught by Bland-Ward et al. using the teachings of Desai et al. because both teachings are directed to aqueous pharmaceutical formulations of therapeutic antibodies, both employ the same conventional formulation components, and Strickley et al. teaches that such components were routinely optimized to obtain a stable aqueous antibody formulations suitable for administration. There would have been a reasonable expectation of success because Desai et al. demonstrates that these excipients can be combined in aqueous antibody formulations and additionally provides specific concentrations and values that are similar to those disclosed by Strickley et al. Furthermore, it would have been obvious to generate the antibody in a pre-filled syringe or autoinjector as the art teaches that such formulations can be stored in those forms and these containers provide a routine means of self-administration, and it would have been obvious to generate a kit comprising the container comprising the pharmaceutical composition as kits are a well established and routine method of commercial distribution (instant claim 37).
Finally, it would have been obvious to combine these teachings and administer the modified composition to a human for the treatment of an autoimmune or inflammatory disease as Bland-Ward et al. teaches that the antibody is suitable for administration to a patent, Desai et al. teaches a composition suitable for administration to a human, and Elhai et al. teaches that OX40L antibodies administered to subjects show reduced inflammation induced injury and that such antibodies are suitable for human administration (instant claim 47). Administration would have therefore constituted no more than utilizing a known composition for its known use in the art on a suitable patient population.
Therefore, claims 1, 4, 8, 9, 11, 13, 17, 18, 20, 21, 25, 28, 29, 31, 35, 36, 37, 47, and 50 are rejected on the ground of non-statutory double patenting.
Conclusion
No claims are allowed.
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/TIRONE D. JOHNSON/ Examiner, Art Unit 1675
/JEFFREY STUCKER/ Supervisory Patent Examiner, Art Unit 1675
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