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, 4-13, 15, 17, 19, 25, 27, 28, and 33, in the reply filed on 04/27/2026 is acknowledged.
Applicant’s election of the species of one triblock copolymer, a MW ratio of 1400 Da - 1500 Da - 1400 Da with LA:GA ratio of 50:50; dimethyl acetamide (DMA) as the polar organic solvent, and a solubility enhancer of PEG 400 is acknowledged. Applicants assert claims 1, 2, 4, 9-13, 15, 17, 19, 25, and 33, encompass the elected species.
Claims 5-8, 27, 28, and 34, 35, and 38, are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention/species, there being no allowable generic or linking claim.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 04/27/2026.
The examiner notes that Applicant’s election of polar organic solvent and solubility enhancer is being treated as an election of a composition comprising a polar organic solvent and solubility enhancer, as claim 1 allows for the inclusion and the exclusion of the two components.
Claim Status
Claims 1, 2, 4-13, 15, 17, 19, 25, 27, 28, 33-35, and 38, are pending.
Claims 5-8, 27, 28, 34, 35, and 38, are withdrawn.
Specification
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
The abstract of the disclosure is objected to because the abstract is 39 words in length, falling short of the 50-150 word length requirement. 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 Interpretation
The examiner best understand “DMA” as used in claim 25 to be dimethyl acrylamide, as defined in claim 15.
Claim Objections
Claim 1 is objected to because of the following informalities:
“and” should be removed following line 12 of component c).
The comma at the end of line 13 of component d) should be replaced by a semicolon.
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.
Claims 1, 2, 4, 9-13, 15, 17, 19, 25, and 33, are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites wherein the PLGA block comprises 40% to 90% of lactic acid (LA) and 10% to 60% of glycolic acid (GA), and it is unclear if the percentages are a wt%, vol%, mol%, etc. For purposes of examination, the claim is interpreted as a mol%.
Claims 1 and 4 recite the limitation "the PLGA polymer block.” There is insufficient antecedent basis for this limitation in the claim. Claim 1 recites a PLGA-PEG-PLGA triblock copolymer where two PLGA blocks are disclosed, and as such, it is unclear as to which PLGA polymer block of the PLGA-PEG-PLGA triblock copolymer the limitation is referring to.
Claims 2, 4, 9-13, 15, 17, 19, 25, and 33, are also rejected for the same reasons for depending upon claim 1.
Claim 4 recites LA and GA percentages of the PLGA block, and ratios of the two, and it is unclear is unclear if the percentages and ratios are a wt%, vol%, mol%, etc. For purposes of examination, the claim is interpreted as a mol% and molar ratio.
Claim 9 recites wherein the triblock copolymer comprises any one of a 50% of lactic acid and 50% of glycolic acid, etc., and it is unclear if the LA:GA ratio is in reference to at least one of the PLGA blocks, each of the PLGA blocks, or something else. For purposes of examination, the claim is interpreted as wherein a PLGA block of the PLGA-PEG-PLGA triblock copolymer comprises any one of a 50% of lactic acid and 50% of glycolic acid, etc., as recited in claim 10.
Claims 10 and 11 are also rejected for the same reasons for depending upon rejected claim 9.
Claim 17 contains the trademark/trade name CREMAPHOR EL, CREMOPHOR RH 60, AND SOLUTOL HS. 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 solubility enhancer components of the instant claim, and, accordingly, the identification/description is indefinite.
Claim 25 recites the limitation "the formulation" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 25 depends from claim 1, where there is no “formulation” claimed. For purposes of examination, the claim is interpreted as “the composition.”
Claim 25 also recites the limitation “the PLGA” in b) (ii). There is insufficient antecedent basis for this limitation in the claim. The claim recites a PLGA-PEG-PLGA triblock copolymer where two PLGA blocks are disclosed, and as such, it is unclear as to which PLGA block of the PLGA-PEG-PLGA triblock copolymer the limitation is referring to.
Claim 25 also recites LA and GA percentages of the PLGA block, and ratios of the two, and it is unclear is unclear if the percentages and ratios are a wt%, vol%, mol%, etc. For purposes of examination, the claim is interpreted as a mol% and molar ratio.
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, 4, 9-13, 15, 17, 19, 25, and 33, are rejected under 35 U.S.C. 103 as being unpatentable over Byrne et al (US 20200038323 A1, hereinafter “Byrne”), in view of Fu (CN 104606129 A, cited on IDS dated 12/28/2023), Jain et al (WO 2009060473 A2, hereinafter “Jain”), and Lu et al (Arch Med Sci, 2013, pp. 614-621, hereinafter “Lu”).
Byrne teaches PLGA-PEG-PLGA hydrogels comprising the PLGA-PEG-PLGA copolymer at a concentration from about 5-30% w/v copolymer (abs, table 1, claim 33). The drugs include local anesthetics, including bupivacaine, lidocaine, etc. (¶ 48). In a particular embodiment the PLGA-PEG-PLGA is 1400 Da - 1500 Da - 1400 Da, with a LA/GA ratio of 1/1 (table 1 B1-1). The LA/GA ratio may range from 35/1 to 1/1 (¶ 11, table 1 B1-1, claim 8). The molecular weight of the PLGA can be from about 750-2500 Da (¶ 41). The PEG may have a molecular weight ranging from about 500-2500 Da (¶ 38). The composition further comprises at least one pharmaceutically acceptable drug carrier, wherein the pharmaceutically acceptable carrier is a pharmaceutically acceptable solvent (¶¶ 38, 43). The carrier may be a solvent containing, for example, water, ethanol, polyol (for example, polyethylene glycol, etc.), organic solvents, suitable mixtures thereof, etc., and other non-toxic compatible substances (¶¶ 86, 88, 107, 108). The biocompatible solvent is included in an amount sufficient to solubilize the biocompatible polymer (¶ 34). The compositions may further contain additional substances including stabilizing agents, permeation enhancers, etc. (¶ 51). The copolymer is present in the composition at a concentration from about 5 mg/μL to about 30 mg/μL, with embodiments comprising 10-25% w/v (¶¶ 15, 29-32, 119, 121, 122). The compositions can be used for various routes of administration, including oral, transdermal, transmucosal, subcutaneous, intramuscular, intravenous, intraocular, topical, etc. (¶¶ 89, 98).
Byrne does not explicitly disclose the % w/v of the active agent, nor an embodiment comprising the elected polar organic solvent (DMA) and solubility enhancer (PEG 400).
Fu teaches thermosensitive hydrogels comprising PLGA-PEG-PLGA copolymer, where it was known to include ropivacaine (local anesthetic drug) in amounts of 1.5% w/v (0.15 g ropivacaine to 10 mL hydrogel) (ex. 1).
Fu does not teach a composition as claimed comprising the elected polar organic solvent (DMA) and solubility enhancer (PEG 400).
Jain teaches injectable depot gel or implant compositions comprising an active agent, at least one biocompatible polymer, and at least one biocompatible non-toxic solvent (abs). The biocompatible polymer includes triblock copolymers of PLGA-PEG-PLGA (pg 20 ln 33). Biocompatible non-toxic solvents include dimethyl acetamide, N-methyl-2-pyrrolidone (NMP), etc. (pg 21 ln 19-27). Co-surfactants are selected from polyethylene glycol, etc., and solvent/co-solvent mixtures comprising dimethyl acetamide, PEG 400, etc., are disclosed. The solvent/co-solvent can be chosen depending on the solubility of the active agent (pg 25 ln 13-27). The solvent may be included from about 0.1% w/w to about 95% w/w (pg 8 ln 3-5).
Jain does not specifically teach DMA and PEG 400 used with local anesthetics.
Lu teaches ropivacaine loaded implants comprising PLGA and ropivacaine, where suitable solvents include N-methyl-2-pyrrolidone (NMP), and PEG 400 as a plasticizer, which was used to modulate drug release (abstract).
Regarding the composition of claim 1, it would have been obvious to formulate a composition comprising a PLGA-PEG-PLGA copolymer and a local anesthetic drug, as taught by Byrne.
Regarding the PLGA-PEG-PLGA copolymer concentration of claim 1, it would have been obvious to formulate the composition made obvious above with a PLGA-PEG-PLGA copolymer concentration of 5-30% w/v, as taught by Byrne, falling within the claimed range.
Regarding the drug concentration of claim 1, where Byrne teaches various local anesthetic drugs, it would have been obvious to include known amounts of local anesthetic drugs suitable for PLGA-PEG-PLGA copolymer hydrogels, such as 1.5% w/v, as taught by Fu.
Regarding the copolymer of claims 1, 2, 4, 9, 10, 11, and 19, it would have been obvious to select from PGLA-PEG-PLGA copolymer with 1400 Da - 1500 Da - 1400 Da, with an LA/GA ratio of 1:1 (i.e., 50:50), as taught by Byrne.
Regarding the polar organic solvent and solubility enhancer of claim 1, where Byrne teaches the compositions comprise biocompatible solvents, it would have been obvious to include known biocompatible solvents suitable for PLGA-PEG-PLGA compositions comprising an active agent that are capable of injection, including solvent/co-solvent mixtures of dimethyl acetamide and PEG 400, as taught by Jain. The skilled artisan would have a reasonable expectation of success in including DMA and PEG 400 into the PLGA-PEG-PLGA compositions comprising local anesthetic agents, where Lu teaches organic solvents and PEG 400 were also known to be used in PLGA based injectable systems of local anesthetic in order to modulate the release profile of the active agent, and Byrne teaches DMA and PEG 400 were known solvent/co-solvents suitable of PLGA-PEG-PLGA compositions comprising an active.
Regarding the amount of polar organic solvent and solubility enhancer of claim 1, where Byrne teaches biocompatible solvents can be included in any amount sufficient to solubilize the biocompatible polymer (i.e., PLGA-PEG-PLGA), and where Jain teaches biocompatible non-toxic solvents for PLGA-PEG-PLGA compositions comprising an active agent were known to comprise solvents in amounts from about 0.1% w/w to about 95% w/w, it would have been well within the relative skills of the skilled artisan to determine the optimal volume percentage of dimethyl acetamide and PEG 400, in order to achieve desired physical properties of the compositions, such as thickness, release properties, loading, etc., for desired treatments and applications. 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 12, it would have been obvious to formulate the composition made obvious above with bupivacaine or lidocaine, as taught by Byrne, depending on the intended use of the compositions and desired treatments, etc. Alternatively, it would have also been obvious to include ropivacaine as the active agent, where Fu teaches ropivacaine was known to be used in PLGA-PEG-PLGA compositions, depending on desired therapeutic activity, etc.
Regarding claim 13, it would have been obvious to include the bupivacaine, lidocaine, or ropivacaine, in known amounts suitable for PLGA-PEG-PLGA copolymers, such as 1.5% w/v, as taught by Fu for the same reasons discussed above. Further, it would have been well within the relative skills of the skilled artisan to have routinely optimized the concentration of the active agent in order to achieve desired active properties, for desired treatments, 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 15, it would have been obvious to include dimethyl acetamide in amounts overlapping the instantly claimed range, for the same reasons disused above by Byrne and Jain. See MPEP 2144.05(I).
Regarding claim 17, it would have been obvious to include PEG 400 in amounts overlapping the instantly claimed range, for the same reasons discussed above by Byrne and Jain. See MPEP 2144.05(I).
Regarding claim 19, where the PLGA-PEG-PLGA triblock copolymer made obvious above comprises 1400 Da - 1500 Da - 1400 Da, the total molecular weight is 4300 Da, falling within the claimed range.
Regarding bupivacaine claim 25, it would have been obvious to select from bupivacaine as the active agent, for the same reasons discussed above.
Regarding the amount of bupivacaine of claim 25, where Byrne teaches various local anesthetic drugs, and where Fu teaches it was known to include local anesthetic drugs at 1.5% w/v, as discussed above, it would have been well within the relative skills of the skilled artisan to routinely optimize the concentration of bupivacaine specifically, in order to achieve desired therapeutic activity for desired intended uses, treatments, severity of the condition to be treated, 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 the PLGA-PEG-PLGA triblock copolymer of claim 25, it would have been obvious to select from PGLA-PEG-PLGA copolymer with 1400 Da - 1500 Da - 1400 Da, with an LA/GA ratio of 1:1 (i.e., 50:50), as taught by Byrne, for the same reasons discussed above.
Regarding the PLGA-PEG-PLGA copolymer concentration of claim 25, it would have been obvious to formulate the composition made obvious above with a PLGA-PEG-PLGA copolymer concentration of 5-30% w/v, as taught by Byrne, overlapping the claimed concentration. 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 DMA and PEG 400 of claim 25, it would have been obvious to include known solvent/co-solvent mixtures suitable for PLGA-PEG-PLGA compositions comprising an active agent, including dimethyl acetamide and PEG 400, for the same reasons discussed above by Byrne, Jain, and Lu.
Regarding the amount of DMA and PEG 400 of claim 25, where Byrne teaches biocompatible solvents can be included in any amount sufficient to solubilize the biocompatible polymer (i.e., PLGA-PEG-PLGA), and where Jain teaches biocompatible non-toxic solvents for PLGA-PEG-PLGA compositions comprising an active agent were known to comprise solvents in amounts from about 0.1% w/w to about 95% w/w, it would have been well within the relative skills of the skilled artisan to determine the optimal volume percentage of dimethyl acetamide and PEG 400, in order to achieve desired physical properties of the compositions, such as thickness, release properties, loading, etc., for desired treatments and applications. 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 33, the dose volume of the composition of claim 1 as instantly claimed is intended use where the dose volume depends on the desired treatment, the subject the composition is intended to be administered to, injection location, the form of administration (i.e., topical, injection, etc.), desired release profile, etc. Accordingly, where the composition is made obvious above and necessarily a total volume, and where Byrne teaches the compositions can be administered by a variety of methods, it appears the composition would be capable of being formulated with a dose volume of 5 ml to 40 ml as instantly claimed, thereby meeting the intended use limitation.
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, 4, 9-13, 15, 17, 19, 25, and 33, are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 12,364,764 B2, hereinafter ‘764, in view of Byrne et al (US 20200038323 A1, hereinafter “Byrne”). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘764 disclose a composition of funapide (active agent) formulated in a PLGA-PEG-PLGA tri-block copolymer, wherein the composition comprises: a) funapide at a concentration of 0.2 to 2% w/w; b) a PLGA-PEG-PLGA tri-block copolymer at a concentration of 5% to 35% w/w: (i) wherein each Poly-Lactic-co-Glycolic acid (PLGA) polymer block has a molecular weight (MW) of 400 to 2550 Da and wherein the Polyethylene Glycol (PEG) polymer block has a MW of 1000-3000 Da; and (ii) wherein the PLGA comprises 40% to 100% of lactic acid (LA) and 60% to 0% of glycolic acid (GA); c) a polar organic solvent at a concentration of 1% to 20% w/w; and d) a solubility enhancer at a concentration of 1% to 20% w/w. The LA:GA ratio is 50:50. The organic solvent is dimethyl acetamide (DMA), and the solubility enhancer is PEG 400, etc. The composition has a dose volume of 5 ml to 40 ml.
The claims of ‘764 do not disclose wherein the active agent is a local anesthetic agent as instantly claimed.
Byrne is discussed above.
It would have been obvious to modify the claim of ‘764 by substituting a local anesthetic, including bupivacaine, lidocaine, etc., for funapide, in order to formulate compositions with desired therapeutic activity, where both are directed to PLGA-PEG-PLGA compositions for delivery of an active agent.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSHUA A ATKINSON whose telephone number is (571)270-0877. The examiner can normally be reached M-F: 9:00 AM - 5:00 PM + Flex.
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/JOSHUA A ATKINSON/
Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
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