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 .
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 29-31 are pending. Claims 1-5, 7, 11, 12, 14, 26, 28, and 29-31 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 Claims 15, 16, 20, and 22 are withdrawn from consideration.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Withdrawn Claim Rejections
All objections to claim 28 are withdrawn in view of the amendments to the claims filed 6/29/2026.
All rejections pertaining to claim 28 under 35 U.S.C. 112(b) are withdrawn in view of the amendments to the claims filed 6/29/2026.
All rejections pertaining to claim 26 under 35 U.S.C. 112(d) are withdrawn in view of the amendments to the claims filed 6/29/2026.
All rejections not reiterated have been withdrawn.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-5, 7, 11, 12, 14, 26, 28, and 29-31 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement.
This is a new matter rejection. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The amended claim 1 recites the limitations “wherein the hydrophilic block consists of a saccharide moiety” and “wherein the amphiphilic block copolymer comprises a hydrophobic domain and a hydrophilic domain in a weight ratio of 3:1 to 1:1”. There is no support in the as-filed application for an amphiphilic block copolymer wherein the hydrophilic block consists of a saccharide moiety and the hydrophobic and hydrophilic domain are in a weight ratio of 3:1 to 1:1.
Regarding claims 2-5, 7, 11, 12, 14, 26, 28, and 29-31, claims depending from rejected claims have also been rejected because the incorporate all of the limitations of the claims from which they depend, but fail to resolve the written description concerns outline above.
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 1-5, 7, 11, 12, 14, 26, 28, and 29-31 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.
Claim 1 recites the limitation “the delivery fluid”. There is insufficient antecedent basis for this limitation in the claim.
Regarding claims 2-5, 7, 11, 12, 14, 26, 28, and 29-31, claims depending from rejected claims have also been rejected because they incorporate all of the limitations of the claims from which they depend, but fail to resolve the indefiniteness concerns outlined above.
Claim Rejections - 35 USC § 103
Applicant’s amendments to the claims filed 6/29/2026 have necessitated the new grounds of rejection.
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, of record) in view of Clark (U.S. Patent Application No. 2017/0143409, publication date: 5/25/2017, of record) and Kulthe et. al. (Designed Monomers and Polymers, pg. 465-521, publication year: 2012), as evidenced by Wyatt Technology Corporation (available 6/1/2013).
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 anti-infective and/or fibrosis inhibiting therapeutic agents may be encapsulated in microcapsules [0433]. Hydrophobic compounds may be contained with a hydrophobic core of the polymeric carrier, and this core is contained with a hydrophilic shell [0436]. The polymer component may be an amphiphilic block copolymer [0692] and may be biodegradable or non-biodegradable [0421]. The term “biodegradable” refers to materials for which the degradation process is at least partially mediated by, and/or performed in, a biological system. Depending on the type of polymer, erosion can occur by mechanisms such as water-soluble polymers that have been insolubilized and that solubilize as the cross-links or the backbone undergo a hydrolytic cleavage, polymers that are solubilized by hydrolysis, ionization, or pronation, and hydrophobic polymers converted to small water-soluble molecules by backbone cleavage [0055]. 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.”
Hunter does not disclose the percentage solubility in the delivery fluid as recited in claim 1. However, the invention as claimed is not structurally distinguishable from the disclosure of Hunter and therefore, the Examiner has a reasonable basis to believe that the properties claimed in the present invention are inherent in the composition taught by the prior art. Since the Patent and Trademark Office does not have the facilities for examining and comparing the claimed composition with that of the prior art, the burden of proof is shifted to the Applicants to show an unobvious distinction between the structural and functional characteristics of the claimed composition and the composition of the prior art; i.e., to prove that the properties are not inherent. See In re Best, 562 F.2d 1252, 195 U.S.P.Q. 430 (CCPA 197) and Ex parte Gray, USPQ 2d 1922 (PTO Bd. Pat. App. & Int.). As recited in MPEP §2112.01 (II): “Products of identical chemical composition cannot have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable.
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].
Regarding claim 30, Hunter teaches the relevant limitations of claim 1 above.
Regarding claim 31, Hunter teaches that Hunter teaches that the hydrophilic polymer component may be heparin [0512]. Wyatt Technology corporation teaches that the molecular weight of heparin ranges from 3 to 50 kDa, but typically falls within the 10 to 20kDa range for unfractionated heparins used in medical applications (pg. 1).
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 or a ratio of hydrophobic to hydrophilic domains in the amphiphilic block copolymer. However, this deficiency is cured by Clark and Kulthe.
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]. Kulthe teaches that the most important factor affecting the process of micelle formation or self-assembly is the size of the hydrophobic domain in the amphiphilic molecule (pg. 466, Micelles: formation and features). The main factor governing the morphology of micelles is the hydrophilic-hydrophobic balance of the block copolymer (pg. 467, Polymeric micelles). The size and morphology of the polymeric micelles developed from amphiphilic block polymers can readily be controlled through adjusting the structure of amphiphilic copolymers as the factors controlling size of the polymeric micelles include the relative proportion of hydrophilic and hydrophobic chains (pg. 467, Attractive features of polymeric micelles). Usually when the length of a hydrophilic block exceeds to some extent than that of a hydrophobic one, spherical micelles are formed from self-assemblage of amphiphilic deblock or triblock copolymers in aqueous solutions. Whereas if the length of a hydrophilic block is too large, copolymers exist in water as individual molecules (unimers) and molecules with lengthy hydrophobic blocks develop various structures (pg. 469, Polymers used for micelle preparation).
Regarding claims 7 and 28, Hunter does not teach a specific release rate of the anti-fibrotic agent.
Regarding claim 30, Hunter does not teach a molecular weight of the hydrophobic block of the amphiphilic block copolymer. However, this deficiency is cured by Kulthe.
Kulthe teaches that the size and morphology of the polymeric micelles developed from amphiphilic block polymers can readily be controlled through adjusting the structure of amphiphilic copolymers as the factors controlling size of the polymeric micelles include the molecular weight of the amphiphilic block copolymer relative proportion of hydrophilic and hydrophobic chains (pg. 467, Attractive features of polymeric micelles). Usually when the length of a hydrophilic block exceeds to some extent than that of a hydrophobic one, spherical micelles are formed from self-assemblage of amphiphilic deblock or triblock copolymers in aqueous solutions. Whereas if the length of a hydrophilic block is too large, copolymers exist in water as individual molecules (unimers) and molecules with lengthy hydrophobic blocks develop various structures (pg. 469, Polymers used for micelle preparation). The critical micelle concentration decreases with increasing hydrophobic block lengths, which can be attributed to the greater hydrophobicity of the block with increasing molecular weight (pg. 476, Critical micelle concentration).
Finding of a Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
Regarding claim 1, the ratio of hydrophobic to hydrophilic domain in the amphiphilic block copolymer 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 ratio in order to best achieve the desired results as such would provide advantageous size and morphological 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, one of ordinary skill in the art would have recognized in view of the teachings of Kulthe that the ratio of hydrophobic to hydrophilic domains in an amphiphilic block copolymer has a direct effect on the size and morphology of micelles formed by the block copolymer. The Examiner considers it prima facie obvious to optimize the ratio of hydrophobic to hydrophilic domains, absent unexpectedly superior properties of the claimed invention. In the instant case, one of ordinary skill in the art would have recognized that the ratio of hydrophobic to hydrophilic domains would have a direct effect on the size and morphology of the micelles formed by the copolymer and therefore be an optimizable variable.
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.
Regarding claim 30, the molecular weight of the hydrophobic block 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 molecular weight in order to best achieve the desired results as such would provide advantageous hydrophobicity of the hydrophobic block. 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, Kulthe teaches that the molecular weight of the hydrophobic block has a direct effect on the hydrophobicity of the block, which in turn has a direct effect on the critical micelle concentration of the block copolymer. The Examiner considers it prima facie obvious to optimize the molecular weight of the hydrophobic domain, absent unexpectedly superior properties of the claimed invention. In the instant case, one of ordinary skill in the art would have recognized that the molecular weight would have a direct effect on the critical micelle concentration of the copolymer 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, of record) in view of Clark (U.S. Patent Application No. 2017/0143409, publication date: 5/25/2017, of record) and Kulthe et. al. (Designed Monomers and Polymers, pg. 465-521, publication year: 2012), 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, of record), as evidenced by Wyatt Technology Corporation (available 6/1/2013).
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 filed 6/29/2026 have been fully considered but they are not persuasive.
On page 7, Applicant argues that the references of record do not disclose or reasonably suggest a formulation with the recited weight ratio of hydrophobic to hydrophilic domains and the solubility in the delivery fluid. This is not found persuasive. As described in the obviousness rejection above, Kulthe teaches that the weight ratio of hydrophobic to hydrophilic domains is a result effective domain and therefore the routine optimization of this ratio would have been obvious. The solubility recited in the amended claim 1 is inherent because the disclosure of Hunter is not structurally distinguishable from the instant claims.
On page 8, Applicant argues that the office is relying on impermissible hindsight in the rejection. This is not found persuasive. In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
On page 8, Applicant argues that the office has provided no reasoning as to why a person of ordinary skill in the art would select the specific combination of components recited in the pending claims. This is not found persuasive. In response, the Examiner respectfully draws attention to MPEP 2123 (I), which states “a reference may be relied upon for all that it would have reasonable suggested to one having ordinary skill in the art, including nonpreferred embodiments”. In the instant case, Hunter teaches the relevant limitations as described above, and therefore a person of ordinary skill in the art could have reasonably chosen the recited elements from the broad disclosure of Hunter.
Conclusion
No claims are allowed.
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 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at 571-272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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ELIZABETH ANNE MEYERSExaminer, Art Unit 1617
/ALI SOROUSH/Supervisory Patent Examiner, Art Unit 1614
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