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 .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 2/11/2026 has been entered.
Election/Restrictions
Applicant’s election without traverse of claims 1-5, 7, 11, 12, 14, 24, and 26 in the reply filed on 5/12/2025 is acknowledged.
Status of the Claims
Claims 1-5, 7, 11, 12, 14-16, 20, 22, 26, 28, and 29 are pending. Claims 1-5, 7, 11, 12, 14, 26, 28, and 29 are under current examination. Claims 15, 16, 20, and 22 are withdrawn from consideration. Claims 6, 8-10, 13, 17-19, 21, 23- 25, and 27 are cancelled.
Withdrawn Claim Rejections
All rejections pertaining to claim 27 are moot because the claim is cancelled in the amendments to the claims filed 2/11/2026.
All rejections not reiterated have been withdrawn.
Claim Objections
Claim 28 is objected to because of the following informalities: Claim 28 is objected to because the claim recites a range for “microparticles or nanoparticles” that falls entirely within a range measured in micrometers. The examiner recommends amending the claim to recite “wherein when the particles have a diameter of 1 micrometer to 5 micrometers, they release up to 100% of the denervation drug after 11 days”. This will not raise concern under 35 USC 112(b) for lack of antecedent basis because the term “particle” finds antecedent basis in the phrase “plurality of particles” recited in the preamble of claim 28 and in claim 3. 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.
Claim 28 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 28 recites limitations on release of denervation drug from microparticles or nanoparticles without making it unambiguously clear that the limitation applies to the “plurality of particles” contained in the formulation of claim 3. As such, the current language does not clearly require the claimed invention to possess the recited drug release properties. The examiner recommends amending the claim to recite “The formulation of claim 3, wherein the plurality of particles comprises microparticles or nanoparticles, and wherein when the particles have a diameter of 1 micrometer to 5 micrometers, they release up to 100% of the denervation drug after 11 days, when the particles have a diameter of 0.5 micrometers to 5 micrometers, they release up to 60% of the denervation drug after 11 days.” This suggested amendment would clarify antecedent basis for the microparticles or nanoparticles having the recited functional properties.
Claim 28 recites different limitations on the release rate of denervation drug that are dependent on the size range of the particles containing the drug; however, there is marked overlap in the range of particle size for each category (05 – 5 micron release up to 60% of drug after 11 days, whereas 1-5 micron particles release up to 100% of drug after 11 days). This effectively applies two release profiles to the same particles because particles having 1 to 5 microns diameter fall in both categories. The claim is indefinite because the release profile required for particles having 1 to 5 microns diameter is unclear.
Claim Rejections - 35 USC § 112
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.
Claim 26 is 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 1, from which claim 26 depends, indicates that the hydrophilic block consists of a saccharide moiety. Claim 26 recites that the amphiphilic block copolymer comprises polyethylene glycol as a hydrophilic domain/block. The recitation of polyethylene glycol in claim 26 does not further limit claim 1 because claim 1 recites that the hydrophilic block consists of a saccharide moiety, thus limiting the hydrophilic block to a saccharide moiety. Pease refer to MPEP 2111.03 (II) which states: “the transitional phrase ‘consisting of’ excludes any element, step, or ingredient not specified in 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.
Response to Arguments
Applicant’s amendments to the claims filed 2/11/2026 have overcome the previous ground of rejection of claim 26 under 112(d). However, the amended claims are rejected as described above.
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 1-5, 7, 12, 14, 26, 28, and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Hunter (U.S. Patent Application No. 2005/0175703, publication year: 2005) in view of Clark (U.S. Patent Application No. 2017/0143409, publication date: 5/25/2017, of record).
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Regarding claim 1, Hunter teaches sustained-release preparations of therapeutic agents that contain both an anti-fibrotic agent and either a polymer or a pre-polymer [0006 and 0420]. The polymer component may be an amphiphilic block copolymer [0692] and may be biodegradable or non-biodegradable [0421]. The hydrophilic polymer component may be heparin [0512]. The polymeric carriers may include polycarbonates [0425]. The active fibrosis-inhibiting compound can include paclitaxel [0085], vincristine sulfate, and vinblastine [0101]. The fibrosis-inhibition compounds can be delivered at appropriate dosages into the tissue [0076]. With regards to the “denervation drug” limitations of instant claim 1, the prior art teaches the same drugs as claimed and therefore, the denervation properties are necessarily present; the Examiner directs attention to MPEP 2112.01 (II) which states: “A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.”
Regarding claim 2, Hunter teaches that the active fibrosis-inhibiting compound can include paclitaxel [0085], vincristine sulfate, and vinblastine [0101].
Regarding claim 3, Hunter teaches that the fibrosis-inhibiting agents may be fashioned in the form of microspheres, microparticles, and/or nanoparticles [0434]. The polymeric carriers are provided which are adapted to contain and release the fibrosis-inhibiting compound [0436].
Regarding claim 4, Hunter teaches that the fibrosis-inhibiting therapeutic agent may be delivered as an aqueous solution [0437] and that the compositions of the invention can be injected within a patient’s body [0063].
Regarding claim 5, Hunter teaches that the microparticles and/or nanoparticles may have any size ranging from 50nm to 500µm [0434].
Regarding claim 7, Hunter teaches the relevant limitations of claim 1 above.
Regarding claim 12, Hunter teaches that the polymeric carriers may include trimethylene carbonate, poly(L-lactic acid), and poly(glycolic acid) [0424].
Regarding claim 14, Hunter teaches that therapeutic compositions that include anti-fibrosis agents may be prepared in gel forms [0435].
Regarding claim 26, Hunter teaches that Hunter teaches that the polymeric carriers may include copolymers of trimethylene carbonate, poly(L-lactic acid), and poly(glycolic acid) [0424]. The hydrophilic polymer may be polyethylene glycol [0523].
Regarding claim 28, Hunter teaches that the microparticles and/or nanoparticles may have any size ranging from 50nm to 500µm [0434].
Regarding claim 29, Hunter teaches that the hydrophilic polymer component may be heparin [0512].
Ascertainment of the Difference Between Scope of the Prior Art and the Claims
(MPEP §2141.02)
Regarding claim 1, Hunter does not teach a specific release rate of the anti-fibrotic agent. However, this deficiency is cured by Clark.
Clark teaches a device for inhibiting nerve regeneration following a denervation procedure that utilizes anti-regeneration agents [0034]. Injectable anti-regeneration compositions may be comprised of fluids that contain particles of the anti-regeneration agent wherein the anti-regeneration agent may be a solid particle, dispersed within a solid matrix material, encapsulated solid particles of anti-regeneration agent, encapsulated particles comprising anti-regeneration agent dissolved or dispersed in a solid matrix material, or encapsulated solutions, dispersion or gels comprising anti-regeneration agent [0046]. Encapsulation materials for the anti-regeneration agents include various synthetic biostable or biodegradable polymers such as fluoropolymers [0048], poly(tri methylene carbonate), poly(lactide-co-trimethylene carbonate), and poly (glycolide-co-trimethylene carbonate) [0049]. Mechanisms for the release of anti-regeneration agent from such particles include bioerosion, diffusion, or a combination of bioerosion and diffusion [0046] and particle size may be varied to change diffusion rates [0052]. The degradation rate can also be controlled by such factors as polymer molecular weight and polymer crystallinity [0050]. The anti-regeneration agent may be released over an appropriate timeframe, or at specific intervals in time, for the particular agent to effectively block nerve regeneration from occurring [0040]. The anti-regeneration agent may be selected from paclitaxel and vincristine [0035].
Regarding claims 7 and 28, Hunter does not teach a specific release rate of the anti-fibrotic agent.
Finding of a Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
Regarding claims 1, 7, and 28 the drug release rate is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and would reasonably expect success. It would have been customary for an artisan of ordinary skill to determine the optimal drug release rate in order to best achieve the desired results as such would provide advantageous anti-fibrosis effect. It would have been prima facie obvious to one of ordinary skill in the art at the time of the invention to engage in routine experimentation to determine optimal or workable ranges that produce expected results. 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. In re Aller, 220 F. 2d 454, 105 USPQ 233 (CCPA 1955). In the instant case, Hunter teaches that the fibrosis-inhibition compounds can be delivered at appropriate dosages into the tissue [0076] and Clark teaches that that particle size or polymer molecular weight and crystallinity may be varied to change the diffusion rate of the neuromodulator drug [0050 and 0052]. The examiner considers it prima facie obvious to optimize the release rate or duration of any biologically active agent to achieve their known biological effect over a desired period of time, absent unexpectedly superior properties of the claimed invention. In the instant case, one of ordinary skill in the art would have recognized that that the release rate and duration of the anti-fibrosis drug would impact the length and effectiveness of the anti-fibrosis effects of the anti-fibrosis agent and therefore be an optimizable variable.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Hunter (U.S. Patent Application No. 2005/0175703, publication year: 2005) in view of Clark (U.S. Patent Application No. 2017/0143409, publication date: 5/25/2017, of record), as applied to claims 1-5, 7, 12, 14, 26, 28, and 29 above, and further in view of Drumheller (U.S. Patent Application No. 2015/0258251, publication year: 2015).
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Regarding claim 11, Hunter teaches that the composition can be in the form of a coating that can comprise a hydrophilic, biodegradable polymer that is physically removed from the surface of the device over time [0370].
Ascertainment of the Difference Between Scope of the Prior Art and the Claims
(MPEP §2141.02)
Regarding claim 11, Hunter does not teach the inclusion of an excipient embraced by the instant claims. However, this deficiency is cured by Drumheller.
Drumheller teaches a medical device for delivering a therapeutic agent to a tissue, the device having a solid surfactant-free particulate coating layer applied to an exterior surface of the device. The coating layer comprises a therapeutic agent and at least one non-polymeric organic additive. The therapeutic agent may be paclitaxel [0012] and the organic additive may be calcium salicylate [0071]. The mixture of paclitaxel and organic additive form a eutectic mixture that exhibits a depressed melting point lower than that of paclitaxel or the organic additive alone. The depressed melting point could allow rapid transfer of the drug from the coating composition to an adjacent tissue while minimizing nonspecific loss of drug from the coating prior to transfer to the adjacent tissue [0098]. The coating may facilitate fast or slower release of paclitaxel [0134].
Finding of a Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious to one of ordinary skill in the art of filing to include calcium salicylate in the polymeric composition embraced by Hunter. One would have understood in view of Drumheller that including calcium salicylate in a solid coating composition comprising paclitaxel can lower the melting point of paclitaxel to facilitate release of the drug at the desired tissue [0098]. It would have been obvious to include such an excipient in the composition embraced by Hunter. One of ordinary skill in the art of filing would have been motivated to include calcium salicylate in order to optimize the release characteristics of the drug from the coating composition. The artisan of ordinary skill in the art of filing would have had reasonable expectation of success because Drumheller teaches that calcium salicylate may be mixed with paclitaxel in a coating composition.
Response to Arguments
Applicant’s arguments with respect to the rejection of claims 1-5, 7, 11, 12, 14, and 26 under 35 U.S.C. 103 over Clark, Bright, and/or SCOGS Report have been considered but are moot because the new ground of rejection does not rely on the teachings of Clark for any teaching or matter specifically challenged in the argument. The teachings of Clark relied upon in the new grounds of rejection do not pertain to the amphiphilic block copolymer or the hydrophilic block of the amphiphilic block copolymer. The new grounds of rejection have addressed the amendments to the claims not disclosed or taught by Clark.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELIZABETH ANNE MEYERS whose telephone number is (571)272-2271. The examiner can normally be reached Monday-Friday 8am-5pm ET.
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ELIZABETH ANNE MEYERSExaminer, Art Unit 1617
/KATHERINE PEEBLES/Primary Examiner, Art Unit 1617