DETAILED ACTION
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on December 19, 2025 has been entered.
Claims 1-20 are pending. Claims 1-20 herein acted on the merits.
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 .
Priority
This Application filed on 01/25/2024 is a CON of PAT 11918572 filed on 01/27/2023 which has a PRO 63/267,256 filed on 01/28/2022.
Information Disclosure Statement
The information disclosure statement(s) (IDS) filed on 11/18/25 and 12/19/25, is in compliance with the provisions of S7 CFR 1.97. Accordingly, the IDS is being considered by the Examiner.
Response to Arguments
Applicant’s arguments over the 35 U.S.C. 103 rejection of claims 1-20 over Nanjing et al. (CN 113827547 A - IDS)) is not persuasive. The rejection is herewith maintained. Applicant argues the reference does not teach nerve block for at least 72 hours as now claimed.
The Examiner points out Nanjing et al. teaches “a preparation provided by the invention is applied in a single dose, and the contained dose can achieve the effects of relieving pain and blocking nerves, and can be used for preventing or relieving local pain.” “The formulation continues to be effective for at least 48 to 72 hours after administration. In some embodiments, the formulation is administered for at least 72 hours after effective treatment is continued.” The arguments are not persuasive.
The Applicant has not made any arguments against the ODP rejection of record. The rejection is herewith maintained.
The newly modified rejections are as below addressing the claim amendments:
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 1-14 are rejected under 35 U.S.C. 103 as being unpatentable over Shen et al. (US 10500281 B2)).
Shen et al. teaches a controlled release semi-solid pharmaceutical composition comprising the semi-solid lipid vehicle gel and a local anesthetics agent. The exemplified local anesthetics agent is bupivacaine used for sciatic nerve block. The semi-solid lipids useful in the formulation described herein are a mixture of one or more monoglycerides, diglycerides, or triglycerides. Bupivacaine can be readily converted to a salt with saturated or unsaturated fatty acids such as lauric acid, myristic acid, palmitic acid, and oleic acid. In addition, polyglyceryl esters with an HLB value of less than 4 and molecular weight of less than 2,000 Dalton (Da), such as polyglyceryl-2-diisostearate (HLB=3.8), polyglyceryl-10-decaoleate (HLB=3.5), or polyglyceryl ester of mixed vegetable fatty acids (HLB=2.5), are also useful semi-solid vehicle. The formulation provide a sustained drug release over a period of days to a month resulting in increased duration of pharmacological action, and reduced frequency of drug administration. The formulation has shear thinning properties ( of a fluid or gel material when mixed or agitated).
While the reference teaches the composition of the claims, the reference fails to teach the weight ratios, as claimed.
It would have been obvious to one of ordinary skill in the art at the time of filing to use of bupivacaine, the lipophilic oil, structuring agents in the claimed amounts. The motivation to use bupivacaine, the lipophilic oil, structuring agents in the amounts claimed is because Shen teaches a long-acting local anesthetic that could safely release pain medication over two to four days that truly relieve pain without systemic side effects would potentially provide a significant advantage over the leading drugs used to treat post-operative pain. Hence, a skilled artisan would have had reasonable expectation of successfully achieving similar efficacy and results. Additionally, since the general conditions of the claim are taught in the prior art, discovering optimum or workable amounts of bupivacaine, the lipophilic oil, structuring agents involves only routine skill in the art (In re Aller).
Claims 15-20 are rejected under 35 U.S.C. 103 as being unpatentable over Shen et al. (US 10500281 B2)), as applied to claims 1-14, in view of Nanjing et al. (CN 113827547 A - IDS)).
Shen et al. is as discussed above.
Shen et al. fails to teach the castor oil as claimed.
Nanjing et al. teaches a pharmaceutical composition (Pg. 4 Para 1) a sustained-release preparation composition; (Pg. 10 Para 1) made of different liquid oils ( table 4-1) comprising: a lipophilic oil (Pg. 4 Para 8 a. liquid oil; Pg. 19 Para 4 ) Different natural vegetable oils and synthetic oil medium chain triglycerides are selected for study, a therapeutic agent, salt, ion pair thereof, or prodrug thereof dispersed in the lipophilic oil (Pg. 16 Para 1 mixing liquid oil, gelator, ropivacaine, the meloxicam concentrated solution and benzyl alcohol at 70, heating while stirring until a transparent and uniform solution is formed} and a structuring agent (Pg. 4 Para 8 .b. At least one pharmaceutically acceptable gelator, Pg. 5 Para 3) The gelator is selected from glyceryl distearate (at least a portion of which Is not dissolved in the lipophilic oil and forms a gel (Pg. 10 Para 1) Example 4 Oleogel compositions containing different liquid oils: Pg. 8 Para 4 The term oleogel refers to a thermally reversible, semi-solid dispersion with certain viscoelasticity resulting from the addition of a gelator to a liquid. The reference teaches the lipophilic oil comprises a monoglyceride, diglyceride, triglyceride, medium-chain triglyceride oil, sesame oil, soybean oil, castor oil, vegetable oil, tributyrin oil, or a mixture thereof (Pg. 4 Para 8, a. liquid oil Pg. 10 Para 1) The reference teaches different natural vegetable oils and synthetic oil medium chain triglycerides.
Nanjing teacehs the triglyceride is 4 saturated triglyceride, a monounsaturated triglyceride, or a polyunsaturated triglyceride (Pg. 10 Para 4 different natural vegetable oils and synthetic oil medium chain triglycerides are taught). Nanjing teaches the pharmaceutical composition wherein the triglyceride comprises a medium-chain triglyceride, a short-chain triglyceride, long-chain triglyceride, or a mixture thereof (Fig. 10 Para 1) and (Pg. 10 Para 7). Nanjing teaches the structuring agent comprises tristearin, glyceryl distearate, glycerol monostearate, glyceryldibehenate, cholesterol, trimyristin, glyceryl dimyristin, glyceryl monomyristin, trilaurin, glyceryl dilaurin, glyceryl monolaurin, tripalmitin, glyceryl dipalmitin, glyceryl monopalmitin, cholesterol, a polyglyceride ester of a fatty acid, a polyglycerol ester of a fatty acid, or a mixture thereof (Pg. 4 Para 8). Nanjing teaches the pharmaceutical composition structuring agent comprises glycerol monostearate, glyceryl distearate, tristearin, glycerol rmonopalmitin, glycerol dipalmitin, tripalmitin, glycerol monomyristin, glycerol dimyristin, trimyristin, or a mixture thereof (Pg. 4 Para 8).
Nanjing teaches the therapeutic agent comprises an analgesic agent, anesthetic agent, anti-inflammatory agent, a sympaitholytic agent, an anxiolytic agent, a cannabinoid, or a mixture thereof dispersed in the Hpophilic oil (Pg. 10 Para 7 mixing liquid oll, gelator, ropivacaine, the meloxicam concentrated solution and benzyl aicohal at 70, heating while stirring until a fansparent and uniform solution is formed; See instant Specification Para [0042] Non-limiting examples of COX-2 inhibitors can include... meloxicam}. Nanjing teaches the analgesic agent, anesthetic agent, or both present in arnount sufficient to reduce pain in a subject (Pg. 7 Para 27) The preparation provided by the invention is applied in a single dose, and the contained dose can achieve the effects of relieving pain and nerves, and can be used for preventing or relieving local pain. Nanjing teaches the analgesic agent (Pg. 10 Para 1 mixing liquid oil, gelator, ropivacaine, the meloxicam concentrated solution and benzyl alcohol. heating while stirring until a transparent and uniform solution is formed; See instant Specification Para [0042] Non-limiting examples of COX-2 inhibitors can include... meloxicam). Nanjing teaches the nonsteroidal anti-inflammatary drug comprises ibuprofen, naproxen, diclofenac, mefenamis acid, indomethacin, cannabidiol, an ion pair thereof, a salt thereof, or a mixture (Pg. 5 Para 5). Nanjing teaches the anesthetic agent comprises an ester- based local anesthetic, an amide-based local anesthetic, or a prodrug, or ion pair thereof, or salt thereof, or a mixture thereof (Pg. 5 Para 5).The ester-based local anesthetic comprises procaine, amethocaine, benzocaine, tetracaine, or a prodrug, or ion pair thereof, or salt thereof, or a mixture thereof (Pg. 8 Para 5 }. Nanjing teaches the local amide-based anesthetic comprises lidocaine, prilocaine, bupivacaine, levobupivacaine, ropivacaine, mepivacaine, dibucaine, etidacaine, a prodrug, or ion pair thereof, or salt thereof, or a mixture thereof (Pg. 5 Para 8). Nanjing teaches the amide-based local anesthetic is an ion pair, or salt, comprising of bupivacaine butyrate, bupivacaine palmitate, bupivacaine laureate, bupivacaine myristate, bupivacaine stearate, bupivacaine hydroxystearate, bupivacaine oleate, bupivacaine ricinolate (anesthetic and hydrophoibic ion paring agent together), bupivacaine docusate (Pg. 5 Para 6). In some embodiments, the viscosity of the composition is in the range of 5000 to 10000cP at 30 ℃. The reference teaches sustained-release analgesic systems, has sustained and stable release of analgesic active ingredients, can be injected for administration, is suitable for stable and convenient local administration, and has good tolerance and little side effect for patients. the formulation further comprises a packaging filled with the formulation, the packaging being selected from one or more of the following: penicillin bottles, pre-filled syringes and clamping bottles, reads on the kit.
It would have been obvious to one of ordinary skill in the art at the time of filing to use castor oil in the claimed amounts. The motivation to use castor oil in the amounts claimed is because Nanjing teaches monoglyceride, diglyceride, triglyceride, medium-chain triglyceride oil, sesame oil, soybean oil, castor oil, vegetable oil, tributyrin oil, or a mixture thereof (Pg. 4 Para 8, a. liquid oil Pg. 10 Para 1) are interchangeable lipophilic oils. Hence, a skilled artisan would have had reasonable expectation of successfully achieving similar efficacy and results. Additionally, since the general conditions of the claim are taught in the prior art, discovering optimum or workable amounts of castor oil involves only routine skill in the art (In re Aller).
Claims 1-20 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Nanjing et al. (CN 113827547 A - IDS)).
Nanjing et al. teaches a pharmaceutical composition (Pg. 4 Para 1) a sustained-release preparation composition; (Pg. 10 Para 1) made of different liquid oils ( table 4-1) comprising: a lipophilic oil (Pg. 4 Para 8 a. liquid oil; Pg. 19 Para 4 ) Different natural vegetable oils and synthetic oil medium chain triglycerides are selected for study, a therapeutic agent, salt, ion pair thereof, or prodrug thereof dispersed in the lipophilic oil (Pg. 16 Para 1 mixing liquid oil, gelator, ropivacaine, the meloxicam concentrated solution and benzyl alcohol at 70, heating while stirring until a transparent and uniform solution is formed} and a structuring agent (Pg. 4 Para 8 .b. At least one pharmaceutically acceptable gelator, Pg. 5 Para 3) The gelator is selected from glyceryl distearate (at least a portion of which Is not dissolved in the lipophilic oil and forms a gel (Pg. 10 Para 1) Example 4 Oleogel compositions containing different liquid oils: Pg. 8 Para 4 The term oleogel refers to a thermally reversible, semi-solid dispersion with certain viscoelasticity resulting from the addition of a gelator to a liquid. The reference teaches the lipophilic oil comprises a monoglyceride, diglyceride, triglyceride, medium-chain triglyceride oil, sesame oil, soybean oil, castor oil, vegetable oil, tributyrin oil, or a mixture thereof (Pg. 4 Para 8, a. liquid oil Pg. 10 Para 1) The reference teaches different natural vegetable oils and synthetic oil medium chain triglycerides.
Nanjing teaches the triglyceride is 4 saturated triglyceride, a monounsaturated triglyceride, or a polyunsaturated triglyceride (Pg. 10 Para 4 different natural vegetable oils and synthetic oil medium chain triglycerides are taught). Nanjing teaches the pharmaceutical composition wherein the triglyceride comprises a medium-chain triglyceride, a short-chain triglyceride, long-chain triglyceride, or a mixture thereof (Fig. 10 Para 1) and (Pg. 10 Para 7). Nanjing teaches the structuring agent comprises tristearin, glyceryl distearate, glycerol monostearate, glyceryldibehenate, cholesterol, trimyristin, glyceryl dimyristin, glyceryl monomyristin, trilaurin, glyceryl dilaurin, glyceryl monolaurin, tripalmitin, glyceryl dipalmitin, glyceryl monopalmitin, cholesterol, a polyglyceride ester of a fatty acid, a polyglycerol ester of a fatty acid, or a mixture thereof (Pg. 4 Para 8). Nanjing teaches the pharmaceutical composition structuring agent comprises glycerol monostearate, glyceryl distearate, tristearin, glycerol rmonopalmitin, glycerol dipalmitin, tripalmitin, glycerol monomyristin, glycerol dimyristin, trimyristin, or a mixture thereof (Pg. 4 Para 8).
Nanjing teaches the therapeutic agent comprises an analgesic agent, anesthetic agent, anti-inflammatory agent, a sympaitholytic agent, an anxiolytic agent, a cannabinoid, or a mixture thereof dispersed in the Hpophilic oil (Pg. 10 Para 7 mixing liquid oll, gelator, ropivacaine, the meloxicam concentrated solution and benzyl aicohal at 70, heating while stirring until a fansparent and uniform solution is formed; See instant Specification Para [0042] Non-limiting examples of COX-2 inhibitors can include... meloxicam}. Nanjing teaches the analgesic agent, anesthetic agent, or both present in arnount sufficient to reduce pain in a subject (Pg. 7 Para 27) The preparation provided by the invention is applied in a single dose, and the contained dose can achieve the effects of relieving pain and nerves, and can be used for preventing or relieving local pain. Nanjing teaches the analgesic agent (Pg. 10 Para 1 mixing liquid oil, gelator, ropivacaine, the meloxicam concentrated solution and benzyl alcohol. heating while stirring until a transparent and uniform solution is formed; See instant Specification Para [0042] Non-limiting examples of COX-2 inhibitors can include... meloxicam). Nanjing teaches the nonsteroidal anti-inflammatary drug comprises ibuprofen, naproxen, diclofenac, mefenamis acid, indomethacin, cannabidiol, an ion pair thereof, a salt thereof, or a mixture (Pg. 5 Para 5). Nanjing teaches the anesthetic agent comprises an ester- based local anesthetic, an amide-based local anesthetic, or a prodrug, or ion pair thereof, or salt thereof, or a mixture thereof (Pg. 5 Para 5).The ester-based local anesthetic comprises procaine, amethocaine, benzocaine, tetracaine, or a prodrug, or ion pair thereof, or salt thereof, or a mixture thereof (Pg. 8 Para 5 }. Nanjing teaches the local amide-based anesthetic comprises lidocaine, prilocaine, bupivacaine, levobupivacaine, ropivacaine, mepivacaine, dibucaine, etidacaine, a prodrug, or ion pair thereof, or salt thereof, or a mixture thereof (Pg. 5 Para 8). Nanjing teaches the amide-based local anesthetic is an ion pair, or salt, comprising of bupivacaine butyrate, bupivacaine palmitate, bupivacaine laureate, bupivacaine myristate, bupivacaine stearate, bupivacaine hydroxystearate, bupivacaine oleate, bupivacaine ricinolate (anesthetic and hydrophoibic ion paring agent together), bupivacaine docusate (Pg. 5 Para 6). In some embodiments, the viscosity of the composition is in the range of 5000 to 10000cP at 30 ℃. The reference teaches sustained-release analgesic systems, has sustained and stable release of analgesic active ingredients, can be injected for administration, is suitable for stable and convenient local administration, and has good tolerance and little side effect for patients. the formulation further comprises a packaging filled with the formulation, the packaging being selected from one or more of the following: penicillin bottles, pre-filled syringes and clamping bottles, reads on the kit. The formulation continues to be effective for at least 48 to 72 hours after administration. In some embodiments, the formulation is administered for at least 72 hours after effective treatment is continued. The preparation provided by the invention is applied in a single dose, and the contained dose can achieve the effects of relieving pain and blocking nerves, and can be used for preventing or relieving local pain.
While the reference teaches the composition of the claims, the reference fails to teach a specific formulation and the amounts, as claimed.
It would have been obvious to one of ordinary skill in the art at the time of filing to use of bupivacaine, the liquid oil, gelator, structuring agents in the claimed amounts. The motivation to use bupivacaine, the liquid oil, gelator, structuring agents in the amounts claimed is because Nanjing teaches the anesthetic formulation is suitable for stable and convenient local administration, and has good tolerance and little side effect for patients. Hence, a skilled artisan would have had reasonable expectation of successfully achieving similar efficacy and results. Additionally, since the general conditions of the claim are taught in the prior art, discovering optimum or workable amounts of bupivacaine, the liquid oil, gelator, structuring agents involves only routine skill in the art (In re Aller).
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 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 11918572. Although the claims at issue are not identical, they are not patentably distinct from each other because an injectable pharmaceutical composition, comprising: a lipophilic oil; a hydrophobic ion pairing agent and an anesthetic dispersed in the lipophilic oil; and a structuring agent at least a portion of which is not dissolved in the lipophilic oil and forms a gel, wherein the pharmaceutical composition is free of a rheological modifier, whereas the patented case an injectable pharmaceutical composition, comprising: bupivacaine in a range of from about 3 wt % to about 7 wt % of the pharmaceutical composition; medium-chain triglyceride oil in a range of from about 39.5 wt % to about 46.5 wt % of the pharmaceutical composition; a castor oil in a range of from about 39.5 wt % to about 46.5 wt % of the pharmaceutical composition; and tristearin in a range of from about 0.5 wt % to about 6 wt % of the pharmaceutical composition, wherein the pharmaceutical composition is free of a rheological modifier and a wt:wt ratio of the medium-chain triglyceride to castor oil is about 50:50. The claims overlap in specific components and amounts.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAYLA SOROUSH whose telephone number is (571)272-5008. The examiner can normally be reached on Monday thru Friday; 8:30 AM to 5:00 PM EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http:/Awww.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, James Henry Alstrum-Acevedo, can be reached on (571)272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LAYLA SOROUSH/ Primary Examiner, Art Unit 1622
Prosecution Insights