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 .
Applicant’s election without traverse of Group I, claims 1, 2, 7, 10, 12-16, 19, 24, 33, 36-51, 54, 57, 64, 66-68, 78, 82, 89, 90, 94, 96, 99, 101, and 116, and the species of a) “MoNi” copolymer, b) antibody, and c) propylene glycol dicaprylate/dicaprate, in the reply filed on 09/22/2026 is acknowledged.
Claims 16, 19, 39, 40, 42, 43, 45, 47-49, 78, 82, 89, 90, 94, 96, 128, and 130 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention/species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 09/22/2026.
Claim Status
Claims 1, 2, 7, 10, 12-16, 19, 24, 27, 33, 36-51, 54, 57, 64, 66-68, 78, 82, 89, 90, 94, 96, 99, 101, 116, 128, and 130 are pending.
Claims 16, 19, 39, 40, 42, 43, 45, 47-49, 78, 82, 89, 90, 94, 96, 128, and 130 are withdrawn.
Claim Interpretation
The examiner best understands the components of claim 12 to be components that are also polypeptides, e.g., polypeptide adjuvants, as many of the listed components include classes that can comprise non-polypeptide agents.
The examiner best understands the parenthetical terms used in claims 15, 36, 67, and 101, to simply be abbreviations for the preceding term, and not an illustrative example of the compound.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because the abstract recites “method of preparing a subject injectable pharmaceutical composition” which is grammatically erroneous, where the indefinite article “a” is used with the adjective “subject” when appearing to refer to the injectable pharmaceutical composition previously recited. The examiner suggests replacing “a subject” with “the”. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claim 33 is objected to because of the following informalities: “wherein weight to weight ratio” should read “wherein the weight to weight ratio”. Appropriate correction is required.
Claim 67 is objected to because of the following informalities: the semicolon should be replaced by a colon following “wherein” in the first line. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b) or pre-AIA 2nd ¶
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.
Claim 68 is 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 68 contains the trademark/trade name MIGLYOL 840. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a liquid carrier and, accordingly, the identification/description is indefinite.
Claim Rejections - 35 USC § 112(d) or pre-AIA 4th ¶
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 38, 44, 67, and 68 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 38 recites “wherein the water-soluble carrier monomer comprises MORPH”. Claim 38 depends from claim 36, where claim 36 recites “a water-soluble monomer selected from… MORPH…”. Where claim 36 recites closed language and claim 38 recites the open language “comprising”, the selection of MORPH of claim 38 results in a broader recitation for MORPH monomer, allowing for additional unrecited monomers to be present. For purposes of examination, the Examiner best understands the limitation to mean wherein the water-soluble carrier monomer is MORPH.
Claim 44 recites “wherein the functional dopant monomer comprises NIP”. Claim 44 depends from claim 36, where claim 3t6 recites “a functional dopant monomer selected from… NIP…”. Where claim 36 recites closed language and claim 44 recites the open language “comprising”, the selection of NIP of claim 44 results in a broader recitation for NIP monomer, allowing for additional unrecited monomers to be present. For purposes of examination, the Examiner best understands the limitation to mean wherein the functional dopant monomer is NIP.
Claim 67 recites wherein the liquid carrier comprises an aralkyl benzoate, however, claim 67 depends from claim 66, and aralkyl benzoate does not appear to fall within the liquid carriers recited by claim 66, and therefore does not further limit the claim.
Claim 68 recites wherein the aralkyl benzoate is benzyl benzoate, which does not appear to fall within the liquid carriers recited by claim 66 for the same reasons discussed above, and therefore does not further limit the claim.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 2, 7, 10, 12-15, 24, 27, 33, 36-38, 41, 44, 46, 50, 51, 54, 57, 64, 66-68, 99, 101, and 116 are rejected under 35 U.S.C. 103 as being unpatentable over Armstrong et al (US 20210292435 A1, hereinafter “Armstrong”), in view of Appel et al (WO 2021211976 A2, hereinafter “Appel”, cited on IDS dated 12/19/2024), as evidenced by Brenntag (Miglyol® 840, retrieved 2026).
Armstrong teaches high-concentration monoclonal antibody formulations suitable for subcutaneous administration, e.g., via a pre-filled syringe (abs). The formulation comprises spray dried particles of monoclonal antibody suspended in a non-aqueous suspension vehicle (abs). The pre-spray dried preparation optionally also comprises one or more excipients, including stabilizers which prevent denaturation and/or aggregation of the antibody during the spray drying process. (¶¶ 36, 119). Excipients include polymers, saccharides, surfactants, amino acids, etc. (¶¶ 36, 64). In one embodiment, the solid particles in the suspension formulation have an average particle diameter from about 2 to about 30 microns, e.g. from about 5 to about 10 microns (e.g. as analyzed by laser diffraction) (¶¶ 37, 131, 143). Additional agents including preservatives, etc., can be included (¶ 162). The antibody concentration in the suspension is about 200 mg/mL or more, such as from about 200-500 mg/mL, etc. (¶¶ 137-140). In embodiments, the liquid carrier is propylene glycol dicaprylate/dicaprate, including MIGLYOL 840 (¶ 214). As evidenced by Brenntag, MIGLYOL 840 has a density of 0.92 g/cm3. In embodiments, the total powder concentration (i.e., particles) was 500 mg/mL with an antibody concentration as high as 333 mg/mL (¶ 179). In embodiments, the antibody and excipient were used in a weight ratio of 1:2 (¶ 184).
Armstrong does not teach the polyacrylamide-based copolymer as instantly claimed.
Appel teaches proteins, including antibodies form aggregates that could trigger immunogenic responses in the body (pg. 21 ln 2-19). Polyacrylamide-based copolymer excipients were known to reduce or prevent aggregation of biologic molecules, increasing stability (pg. 21 ln 20-22). The polyacrylamide-based copolymers can be used with any molecule that is susceptible to aggregation including antibodies, including monoclonal antibodies, etc. (pg. 21 ln 20-30). The polyacrylamide-based copolymers can be used with nanoparticles to prevent or reduce aggregation (pg. 22 ln 5-9). The polyacrylamide-based copolymers comprise a water-soluble carrier monomer with an acrylamide reactive moiety and a functional dopant monomer with an acrylamide reactive moiety (pg. 4 ln 4-6). The polyacrylamide-based copolymers exhibit increased stability, such as increased thermal stability, as compared to the same formulations that do not contain the polyacrylamide-based copolymers (pg. 4 ln 8-11). In some embodiments, the composition comprises the protein in a concentration at least two times greater, at least three times greater, at least four times greater, or at least five times greater than the concentration of the same protein in the composition without the copolymer (pg. 48 ln 19-30). The water-soluble carrier monomer is selected from 4-acryloylmorpholine (MORPH) and the functional dopant monomer is selected from N-isopropylacrylamide (NIP) (pg. 6 1st ¶). In a particular embodiment, MoNi 23% (77% MORPH, 23% NIP) was used (pg. 59 ln 19-21, pg. 95 ln 29). As evidenced by the instant specification, 77% morph and 23% NIP copolymer has a number-average molecular weight of about 3,200 g/mol and a degree of polymerization of about 26 (see ¶ 135 of the instant specification). The polyacrylamide-based copolymers can be dried (pg. 73 ln 13). The polyacrylamide-based copolymer is included at about 0.001 to about 5 wt% of the formulation (pg. 70 ln 21 to pg. 72 ln 5). In particular embodiments, MoNi was used at 0.01 wt% (pg. 107 ln 16-17). In embodiments, the ratio of polyacrylamide-based copolymer to active agent is from about 1:1 to about 1:20 (pg. 59 ln 22-27). The degree of polymerization is about 10 to about 500 and the average molecular weight is about 1,000 to about 40,000 g/mol (pg. 5 ln 23-29, pg. 43 ln 18 to pg. 45 ln 11, pg. 46 ln 7-20).
Regarding claim 1, it would have been obvious to formulate an injectable pharmaceutical composition comprising particles, wherein the particles comprise an excipient and an antibody (i.e., biopharmaceutical agent), such as monoclonal antibodies, wherein the particles are suspended in a liquid carrier, as taught by Armstrong.
Regarding the copolymer, where Armstrong teaches excipients, including polymers, etc., are suitable for preventing agglomeration of antibodies, it would have been obvious for the skilled artisan to substitute and/or include other known excipients that were known prevent aggregation of antibodies in aqueous mediums, including polyacrylamide-based copolymers comprising MORPH and NIP, including the MoNi copolymer taught by Appel. See MPEP 2143 I.(A) and (B). The skilled artisan would have had a reasonable expectation of success in using MoNi as the excipient, where the copolymer was known to be capable of being dried and is used for the same purpose of preventing agglomeration of antibodies.
Regarding the liquid carrier, it would have been obvious to select from propylene glycol dicaprylate/dicaprate as the liquid carrier, including MIGLYOL 840, as taught by Armstrong.
Regarding claim 2, it would have been obvious to formulate the particles with a mean diameter from about 2 to about 30 microns, e.g. from about 5 to about 10 microns, as taught by Armstrong, falling within the claimed range.
Regarding claim 7, it would have been obvious to further include stabilizing agents, preservatives, sugars, etc., were Armstrong teaches that other agents can be included, in order to achieve desired formulation properties such as stability, etc.
Regarding claim 10, where antibodies are taught by Armstrong and Appel as being susceptible to aggregation in an aqueous medium, the limitation is met.
Regarding claims 12, 13, 14, and 15, monoclonal antibodies are made obvious above, thereby meeting the claimed limitations.
Regarding claim 24, it would have been obvious to formulate the composition made obvious above comprising the biopharmaceutical agent in an amount ranging from 200 mg/mL or more, such as from about 200-500 mg/mL, etc. Where the liquid carrier made obvious above is MIGLYOL 840, having a density of 0.92 g/cm3, the resulting wt% of biopharmaceutical agent ranges from 17.86 wt% or more, such as from about 17.86 wt% to about 35.21 wt%, overlapping the claimed range. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
Regarding claim 27, it would have obvious to include known amounts of polyacrylamide-based copolymer know to be suitable for stabilizing antibodies, including from about 0.001 to about 5 wt% of the formulation, as taught by Appel, overlapping the claimed range. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
Regarding claim 33, it would have been obvious to formulate the composition made obvious above with a weight ratio of the polyacrylamide-based copolymer to the biopharmaceutical agent within the known ratios suitable for stabilizing excipient to biopharmaceutical agent taught by Armstrong, such as 1:2, falling within the claimed range. Further, where Appel teaches embodiments comprising a protein therapeutic to polyacrylamide-based copolymer at a weight ratio of 1:34 (3.4 mg/mL protein agent to 0.1 mg/mL MoNi), and Appel teaches the polyacrylamide-based stabilizing excipient can be included in amounts ranging from about 0.001 to about 5 wt% of the formulation, it would have been obvious to select within the known ratios suitable for stabilizing protein biopharmaceutical agents, overlapping the claimed range. Additionally, it would have been well within the relative skills of the skilled artisan to have routinely optimized the ratios, where amount of copolymer can vary, in order to achieve desired and optimal stabilization depending on the particular antibody and desired concentrations. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05(II)(A).
Regarding claims 36-38, 41, 44, 46, 50, 51, and 54, where MoNi is made obvious above, comprising 77% MORPH and 23% NIP, the limitations are met.
Regarding claim 57, where MoNi is made obvious above, comprising 77% MORPH and 23% NIP, and where the instant specification evidences the polyacrylamide-based copolymer comprising 77% MORPH and 23% NIP comprises a number-average molecular weight of about 3,200 g/mol and a degree of polymerization of about 26, it appears the limitations are met. Purely arguendo, if somehow the molecular weight and degree of polymerization would be different, it would have been obvious to formulate the polyacrylamide-based copolymer with a number-average molecular weight and degree of polymerization within those ranges taught to ne suitable by Appel, overlapping the claimed range. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
Regarding claims 64, 66, 67, and 68, where MIGLYOL 840 (i.e., propylene glycol dicaprylate/dicaprate) is made obvious above, the limitations are met.
Regarding claim 99, it would have been obvious to formulate the composition wherein the composition comprises weight ratios from the working embodiments of Armstrong, such as a weight ratio of liquid carrier to particles of 1.8:1, as taught by Armstrong, falling within the claimed range, where embodiments comprise 500 mg/mL particles and wherein the carrier made obvious above is MIGLYOL 840, having a density of 0.92 g/cm3 (0.92/0.500 = 1.84:1). Further, it would have been well within the relative skills of the skilled artisan to have routinely adjusted the weight ratio of the liquid carrier and particles, in order to achieve desired amount of biopharmaceutical agent for effective treatments depending on the severity and condition to be treated, the viscosity, etc. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05(II)(A).
Regarding claim 101, it would have been obvious to formulate an injectable pharmaceutical composition comprising particles comprising an antibody and MoNi (MORPH, NIP), suspended in MIGLYOL 840 (i.e., propylene glycol dicaprylate/dicaprate), for the same reasons discussed above.
Regarding claim 116, it would have been obvious to formulate a syringe loaded with the composition made obvious above, as taught by Armstrong.
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, 2, 7, 10, 12-15, 24, 27, 33, 36-38, 41, 44, 46, 50, 51, 54, 57, 64, 66-68, 99, 101, and 116 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 19/365,821 (reference application), hereinafter ‘821, in view of Armstrong et al (US 20210292435 A1, hereinafter “Armstrong”) and Appel et al (WO 2021211976 A2, hereinafter “Appel”, cited on IDS dated 12/19/2024). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘821 disclose an aqueous composition comprising an antibody and about 01-10 wt% of a polyacrylamide-based copolymer, wherein the polyacrylamide-based copolymer comprises: (i) 70 wt% to 98 wt% of a water-soluble carrier monomer comprising a first acrylamide monomer and (ii) 2 wt% to 30 wt% of a functional dopant monomer comprising a second acrylamide monomer. The water-soluble carrier monomer is selected from 4-acryloylmorpholine (MORPH). The functional dopant monomer is selected from N- isopropylacrylamide (NIP). The antibody is selected from the group consisting of a monoclonal antibody, a chimeric antibody, a bispecific antibody, an antibody fragment, and an antibody-drug conjugate. The copolymer has a degree of polymerization of 10-500 and a number-average molecular weight of 2,000-10,000 g/mol. The composition comprises about 2.5-20 wt% of the antibody.
The claims of ‘821 do not disclose particles specifically, further comprising an agent of claim 7, the liquid carrier as instantly claimed, the specific ratios of copolymer to biopharmaceutical agent as claimed, the weight ratio of liquid carrier to particles as claimed, nor a syringe.
The references are recited above.
It would have been obvious to modify the composition of ‘821, by formulating an injectable composition comprising particles comprising the antibody and the polyacrylamide-based copolymer suspended in a liquid carrier, including MIGLYOL 840, for the same reasons discussed above by Armstrong and Appel, where all are directed to compositions comprising an antibody and a polyacrylamide-based copolymer, in order to stabilize the biopharmaceutical agent for desired uses. The additional limitations of the dependent claims would have been obvious for the same reasons discussed above.
It would have been obvious to formulate the particles within those amounts of antibody and copolymer disclosed by the claims of ‘821, and for the same reasons discussed above by Armstrong and Appel, in order to achieve desired formulation properties, active agent concentrations for desired treatments, etc., overlapping the amounts and ratios as instantly claimed. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
It would have been obvious to formulate the composition with known weight ratios of liquid carrier to particles, for the same reasons discussed above by Armstrong.
It would have been obvious to formulate the composition in a syringe, where injectable particulate antibody compositions comprising a polyacrylamide-based copolymer were known to be formulated into a syringe, as taught by Armstrong.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The following are also rejected for the same reasons:
Copending Application no. 18/881,142, while the claims disclose a composition comprising a polyacrylamide-based copolymer comprising MORPH and NIP, and the biopharmaceutical agent insulin, the claims do not disclose particles specifically, antibodies, the liquid carrier as instantly claimed, the specific ratios of copolymer to biopharmaceutical agent as claimed, the weight ratio of liquid carrier to particles as claimed, nor a syringe. It would have been obvious to modify the claims of ‘142 based on the teachings of Armstrong and Appel as applied to each claimed limitation, for the same reasons discussed above. It would have been obvious to include a biopharmaceutical agent, including an antibody, where polyacrylamide-based copolymers were known to stabilize antibodies and prevent aggregation, for desired treatments, etc., as taught by Armstrong and Appel.
Claims 1, 2, 7, 10, 12-15, 24, 27, 33, 36-38, 41, 44, 46, 50, 51, 54, 57, 64, 66-68, 99, 101, and 116 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 12,144,862 B2, hereinafter ‘862, in view of Armstrong et al (US 20210292435 A1, hereinafter “Armstrong”) and Appel et al (WO 2021211976 A2, hereinafter “Appel”, cited on IDS dated 12/19/2024). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘862 disclose a composition comprising a polyacrylamide-based copolymer comprising MORPH and NIP, and an antibody. The copolymer comprises 70 wt % to 98 wt % of the water-soluble carrier monomer and 2 wt % to 30 wt % of the functional dopant monomer. The composition comprises 0.1 wt % to 10 wt % of the copolymer, wherein a degree of polymerization of the copolymer is 10 to 500, and wherein a number-average molecular weight of the copolymer is 2,000 g/mol to 10,000 g/mol. The composition comprises 5 wt% or more of the antibody. The antibody is a monoclonal antibody, etc. The compositions further comprise a surfactant and a stabilizer. The composition is formulated for subcutaneous administration, wherein the composition comprises a suspension of particles in a liquid carrier, wherein the particles comprise the polyacrylamide-based copolymer and the antibody.
The claims of ‘862 do not disclose the liquid carrier as instantly claimed, the specific ratios of copolymer to biopharmaceutical agent as claimed, the weight ratio of liquid carrier to particles as claimed, nor a syringe.
It would have been obvious to modify the composition of ‘862, by formulating an injectable composition comprising particles comprising the antibody and the polyacrylamide-based copolymer suspended in a liquid carrier, including MIGLYOL 840, for the same reasons discussed above by Armstrong and Appel, where all are directed to compositions comprising an antibody and a polyacrylamide-based copolymer, in order to stabilize the biopharmaceutical agent for desired uses. The additional limitations of the dependent claims would have been obvious for the same reasons discussed above.
It would have been obvious to formulate the particles within those amounts of antibody and copolymer disclosed by the claims of ‘862, and for the same reasons discussed above by Armstrong and Appel, in order to achieve desired formulation properties, active agent concentrations for desired treatments, etc., overlapping the amounts and ratios as instantly claimed. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
It would have been obvious to formulate the composition with known weight ratios of liquid carrier to particles, for the same reasons discussed above by Armstrong.
It would have been obvious to formulate the composition in a syringe, where injectable particulate antibody compositions comprising a polyacrylamide-based copolymer were known to be formulated into a syringe, as taught by Armstrong.
The following are also rejected for the same reasons:
U.S. Patent no. 12,472,260 B2, while the claims disclose a composition comprising an antibody and a polyacrylamide-based copolymer comprising MORPH and NIP, the claims do not disclose particles specifically, further comprising an agent of claim 7, the liquid carrier as instantly claimed, the specific ratios of copolymer to biopharmaceutical agent as claimed, the weight ratio of liquid carrier to particles as claimed, nor a syringe. It would have been obvious to modify the claims of ‘260 for the same reasons discussed above in view of Armstrong and Appel, as applied to each claimed limitation.
U.S. Patent no. 11,945,892 B2, while the claims disclose a composition comprising a polyacrylamide-based copolymer comprising MORPH and NIP, the claims do not disclose particles specifically, a biopharmaceutical agent, further comprising an agent of claim 7, the liquid carrier as instantly claimed, the specific ratios of copolymer to biopharmaceutical agent as claimed, the weight ratio of liquid carrier to particles as claimed, nor a syringe. It would have been obvious to modify the claims of ‘892 for the same reasons discussed above in view of Armstrong and Appel, as applied to each claimed limitation. It would have been obvious to include a biopharmaceutical agent, including an antibody, where polyacrylamide-based copolymers were known to stabilize antibodies and prevent aggregation, for desired treatments, etc., as taught by Armstrong and Appel.
U.S. Patent no. 12,077,621 B2, while the claims disclose a composition comprising a polyacrylamide-based copolymer comprising MORPH and NIP, the claims do not disclose particles specifically, a biopharmaceutical agent, further comprising an agent of claim 7, the liquid carrier as instantly claimed, the specific ratios of copolymer to biopharmaceutical agent as claimed, the weight ratio of liquid carrier to particles as claimed, nor a syringe. It would have been obvious to modify the claims of ‘621 for the same reasons discussed above in view of Armstrong and Appel, as applied to each claimed limitation. It would have been obvious to include a biopharmaceutical agent, including an antibody, where polyacrylamide-based copolymers were known to stabilize antibodies and prevent aggregation, for desired treatments, etc., as taught by Armstrong and Appel.
U.S. Patent no. 12,187,828 B2, while the claims disclose a composition comprising a protein or peptide biopharmaceutical agent that are susceptible to aggregation in an aqueous medium, and a polyacrylamide-based copolymer comprising MORPH and NIP, the claims do not disclose particles specifically, further comprising an agent of claim 7, the liquid carrier as instantly claimed, the specific ratios of copolymer to biopharmaceutical agent as claimed, the weight ratio of liquid carrier to particles as claimed, nor a syringe. It would have been obvious to modify the claims of ‘828 for the same reasons discussed above in view of Armstrong and Appel, as applied to each claimed limitation. It would have been obvious to select from antibodies as the protein active agent, where Armstrong teaches antibodies are susceptible for aggregation in an aqueous medium, in order to prevent aggregation of antibodies depending on desired treatments, etc.
U.S. Patent no. 12,643,968 B2, while the claims disclose a composition comprising a polyacrylamide-based copolymer comprising MORPH and NIP, the claims do not disclose particles specifically, a biopharmaceutical agent, further comprising an agent of claim 7, the liquid carrier as instantly claimed, the specific ratios of copolymer to biopharmaceutical agent as claimed, the weight ratio of liquid carrier to particles as claimed, nor a syringe. It would have been obvious to modify the claims of ‘968 for the same reasons discussed above in view of Armstrong and Appel, as applied to each claimed limitation. It would have been obvious to include a biopharmaceutical agent, including an antibody, where polyacrylamide-based copolymers were known to stabilize antibodies and prevent aggregation, for desired treatments, etc., as taught by Armstrong and Appel.
Conclusion
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/JOSHUA A ATKINSON/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
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