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 .
Withdrawal of Previous Office Action
The Final Rejection mailed on November 6, 2025 has been withdrawn in order to correct a typographical error within the rejections. This office action fully replaces said Final Rejection.
Summary
Receipt of the Applicant’s remarks and amended claims dated August 19, 2025 is acknowledged.
Claims 1, 3-4, 7, 9, 17, 22, 26 and 31 are pending in this application.
Claims 2,5-6, 8, 10-16, 18-21, 23-25 and 27-30 have been cancelled.
Claims 1, 17, and 22 have been amended.
Claim 31 is new.
Claims 3-4, 7, 9, and 26 are withdrawn from consideration due the restriction requirement dated September 12, 2025.
Claims 1, 17, 22, and 31 are under examination in this application.
Withdrawn Objections/Rejections
Specification
The objection to the disclosure because the acronym NSAID is not defined has been withdrawn after reconsideration of the term being an art recognized and commonly employeed acronym.
Claim Objections
The objection to claims 1 and 6 because:
claim 1 recites “polylacticco-glycolic acid” has been withdrawn in view of the amendment to the claim to recite “poly(lactic-co-glycolic acid)”;
claim 1 recite “a eutectic composition” in section i) has been withdrawn in view of the amendment to the claim to recite “an eutectic composition”;
claim 6 recites the acronym NSAID for non-steroidal anti-inflammatory drug has been withdrawn in view of the cancellation of the claim.
Claim Rejections - 35 USC § 112
The rejection of claims 6, 13, 19 and 22 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 because:
claims 6 and 13 recite “anesthetics including local anesthetics” and “agents which regulate bleeding including anti-coagulants or coagulants” has been withdrawn in view of the cancellation of the claims;
claims 18-19 recite “comprising, consisting essentially of, or consisting of..” in lines 1-2 has been withdrawn in view of the cancellation of the claims; and
claim 22 recites, in section c-e and g, reference table #s has been withdrawn in view of the deletion of table references.
Claim Rejections - 35 USC § 103
The rejection of claims 1, 5-6, 12-13, 17-19, and 22 under 35 U.S.C. 103 as being unpatentable over Myers et al. (US 2007/0154527) has been withdrawn in view of the amendments to claim 1 to recite the device is insertable or implantable and a specific formulation of the eutectic composition.
Newly Applied Objections/s Rejections
Claim Objections
Claims 1, 22 and 31 are objected to because of the following informalities:
Regarding claim 1, the combination of lidocaine and myristic acid is recited twice.
Regarding claims 22 and 31, the claims recite “the” before recitation of “the EVA” in line 2 of claim 22 and “the lidocaine” and “the ibuprofen” in line 2 of claim 31. The term “the” is unnecessary and does not read well.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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, 17, 22, and 31 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.
Regarding claim 1, the claim has been amended to recite “poly(lactic-co-glycolic acid)polylactic acid (PLA). However, PLA is polylactic acid. It is unclear if Applicant is claiming a copolymer of PLGA-PLA or if there is a typographical error in the claim and should recite “poly(lactic-co-glycolic acid) (PLGA), polylactic acid (PLA)” as two different polymers. Clarification is requested.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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, 22, and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Dang et al. (US 2002/0045668) in view of Paavola et al. (Controlled release and dura mater permeability of lidocaine and ibuprofen from injectable poloxamer-based gels, Journal of Controlled Release 52 1998) 169-178).
Dang discloses a polymer system, such as a biocompatible and optionally biodegradable polymer, comprising an analgesic agent, such as lidocaine or an analog thereof (paragraph 0005).
Additional analgesic agents disclosed as suitable for inclusion include bupivacaine and ropivacaine (paragraph 0037). The analgesic agents are disclosed to be a eutectic composition (paragraph 0125).
The biocompatible/biodegradable polymer can include polylactide (polylactic acid), polyglycolide (polyglycolic acid), polycaprolactone (paragraph 0152), for example.
The polymer system is intended for in vivo use, such as implantation or injection into a patient (paragraph 0039). The degradation rates of the polymer often depends on a variety of factors include the physical characteristics of the implant (paragraph 0042).
Regarding claim 22, as noted above, the polymer can be polycaprolactone.
Dang does not disclose the eutectic composition consists essentially of any of the combination of agents recited in 1b of the instant claims.
Paavola discloses long acting single dose injectable formulation. The injectable gel is for the release of lidocaine and ibuprofen (abstract). While Paavola discloses the gel is eutectic and only contains lidocaine and ibuprofen, Applicant’s attention is directed to MPEP 2111.03 which discloses the transitional phrase "consisting essentially of" limits the scope of a claim to the specified materials or steps "and those that do not materially affect the basic and novel characteristic(s)" of the claimed invention. In re Herz, 537 F.2d 549, 551-52, 190 USPQ 461, 463 (CCPA 1976).
Regarding claim 31, as noted above, the combination of lidocaine and ibuprofen.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to have used the eutectic formulation disclosed by Paavola in the device disclosed by Dang in order to release the analgesic in a sustained and effective manner over a period of time.
Claims 1, 17, 22, and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Grossman et al. (WO9600047) in view of Paavola et al. (Controlled release and dura mater permeability of lidocaine and ibuprofen from injectable poloxamer-based gels, Journal of Controlled Release 52 1998) 169-178).
Grossman discloses a non-abusable, non-inflammatory, biocompatible, non-biodegradable, subcutaneous, polymeric implant for the prolonged, controlled release of opioid analgesics (Abstract).
Examples of polymers include EVA (ethylene vinyl acetate) (The Matrix).
Regarding claim 17, the cylindrical implant is 5-100 mm (Implant Geometry).
Regarding claim 22, as noted above, EVA is disclosed.
Grossman does not disclose the eutectic composition consists essentially of any of the combination of agents recited in 1b of the instant claims.
Paavola discloses long acting single dose injectable formulation. The injectable gel is for the release of lidocaine and ibuprofen (abstract). While Paavola discloses the gel is eutectic and only contains lidocaine and ibuprofen, Applicant’s attention is directed to MPEP 2111.03 which discloses the transitional phrase "consisting essentially of" limits the scope of a claim to the specified materials or steps "and those that do not materially affect the basic and novel characteristic(s)" of the claimed invention. In re Herz, 537 F.2d 549, 551-52, 190 USPQ 461, 463 (CCPA 1976).
Regarding claim 31, as noted above, the combination of lidocaine and ibuprofen.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to have used the eutectic formulation disclosed by Paavola in the device disclosed by Grossman in order to release the analgesic in a sustained and effective manner over a period of time.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELISSA S MERCIER whose telephone number is (571)272-9039. The examiner can normally be reached M-F 6:30 am to 4 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A Wax can be reached on 571-272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MELISSA S MERCIER/ Primary Examiner, Art Unit 1615
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