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 33-40, and 46-50, in the reply filed on 03/11/2026 is acknowledged.
Claims 41-45, 51, and 52, are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03/11/2026.
Claim Status
Claims 33-52 are pending.
Claims 41-45, 51, and 52, are withdrawn.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because the abstract is less than 50 words in length and recites the term “said” in line 4. 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 Objections
Claim 33 is objected to because of the following informalities: the claim recites “solid particulate hydrogel particles” The limitation of particulate particles is redundant where particulates implies particles, and particles implies particulates. Appropriate correction is required.
Claims 34 is objected to because of the following informalities: “Claims 33” should read “claim 33”. Appropriate correction is required.
Claims 34-40, and 47-50, are objected to because of the following informalities: “Claim” should be lowercase. Appropriate correction is required.
Claims 37 is objected to because of the following informalities: “um” should read “µm” or “microns”. Further, a space is missing between the range and the units. 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 33-40, and 47-50, 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 33 recites “a carrier medium in a different physical phase,” and it is unclear what other physical phase the carrier medium is different from. For example, is it different from the neuromodulating agent, different from the solid particulate hydrogel particles, or something else? Further, it is unclear how the physical phases are different. For example, two separate liquid phases could be considered different physical phases; likewise, solid vs. liquid could be considered different physical phases. For purposes of examination, the examiner is interpreting the limitation as any phase other than a solid.
Claim 33 also recites “a singular depot,” and it is unclear what is required for the depot to be considered singular. For example, can multiple hydrogels in close proximity be considered a singular depot or do they have to share one structure to be considered singular?
Claims 34-40 are also rejected for the same reasons for depending upon rejected claim 33.
Claim 40 recites “a reactive hydrogel particulate system,” and it is unclear what a reactive hydrogel particulate system is, where the term is not defined in a previous claim nor in the instant specification. For purposes of examination, the claim is interpreted as the singular depot for sustained release of claim 1.
Claim 47 recites the limitation "the particle" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 47 depends from claim 46, where a plurality of solid particles are claimed. Accordingly, “the particle” of claim 47 lacks antecedent basis.
Claim 48 recites “a reactive hydrogel particulate system,” and it is unclear what a reactive hydrogel particulate system is, where the term is not defined in a previous claim nor in the instant specification. For purposes of examination, the claim is interpreted as the hydrogel depot capable of sustained delivery of claim 46.
The term “highly soluble” in claim 49 is a relative term which renders the claim indefinite. The term “highly soluble” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Further, it is unclear what medium the agent is “highly soluble” in. For example, is the agent highly soluble in aqueous, highly soluble in organic solvents, etc.?
For purposes of examination, the claim is interpreted as wherein the agent is simply soluble in aqueous.
Claim 49 recites “wherein the agent… releases >24 hours,” and from the claim, it is not clear what this limitation means. Is the agent releasing something, is the agent being sustainedly released from the hydrogel depot for more than 24 hours, or is the agent not released until after 24 hours? For purposes of examination, the claim is interpreted as wherein the hydrogel depot sustainedly releases the agent for at least 24 hours.
Claim 50 recites “wherein the agent is encapsulated in a hydrophobic secondary polymer for suspension within precursor melt particles.” It is unclear if the precursor melt particles are intended to further limit the solid particles suspended in an injectable carrier medium of claim 46, or if they are an additional component. If intended to further limit the solid particles of claim 46, it is unclear how “melt” particles would be solid, where the suspension of the agent within a “melt” implies that they are in a flowable, liquid, or non-solid state. As best understood by the examiner, the claim appears to be a product by process limitation for producing solid precursor particles comprising an encapsulated agent, where the instant specification recites that “agents may be mixed with the reactive precursors during melt formation… used to form the solid particles (see ¶ 26 of the instant specification). See also “solid melt particles may be 3D printed or mechanically ground and sieved,” suggesting that the melt particles are intended to be formulated into a solid (see ¶ 106 of the instant specification).
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 33-40 are rejected under 35 U.S.C. 103 as being unpatentable over Campbell et al (US 20110142936 A1, hereinafter “Campbell”).
Campbell teaches a pharmaceutically acceptable implant system comprising hydrogel particles that are suspended in a liquid and applied to a site (abs, ¶¶ 103, 128, 159, claim 1). The implants may be formulated in situ (¶¶ 55, 66, 67). The hydrogel particles are made with precursors, and the precursors may be dissolved in, or suspended in, a liquid and applied to the site (¶¶ 103, 109). The particles may be created and then broken up by grinding, etc. (¶ 109). The hydrogel may comprise therapeutic agents that are released over a period of time, where rate of release from the hydrogel will depend on the properties of the drug and the hydrogel, with factors including drug sizes, relative hydrophobicities, hydrogel density, hydrogel solids content, and the presence of other drug delivery motifs, e.g., microparticles. (¶¶ 66, 92). The hydrogel precursor may be used to deliver different classes of drugs including local anesthetics, etc. (¶ 93). The particles may be fully hydrated, partially hydrated, or desiccated (¶ 129). The particle solvent may be water, with salts or buffers being present as desired (¶ 134). The particles may be spheroidal and range from about 10 to about 500 microns (¶¶ 110, 116). The hydrogel particles may be formulated via a variety of methods (¶ 111). Hydrogels are materials that do not dissolve in water and retain a significant fraction (more than 20%) of water within their structure (¶ 28). The system is suitable for injection (¶ 134).
Regarding claim 33, it would have been obvious to formulate a implant system comprising an anesthetic agent (i.e., a neuromodulating agent), solid hydrogel particles, and a liquid carrier medium, as taught by Campbell.
Regarding the limitation of in situ formation of a singular depot for sustained release of the agent, the limitation appears to be the intended use of the implant system. Accordingly, where the system made obvious above comprises solid hydrogel particles, a neuromodulatory agent, and a carrier medium, appearing to meet the claimed limitations, it appears the system would be capable of in situ formation of a singular depot for controlled release of the agent. Purely arguendo, even if not, it would have been obvious to formulate the system made obvious that is capable of in situ formation of a singular depot for sustained release, where in situ implants for sustained release of actives are taught by Campbell, and where the hydrogel particles can also be delivered in a dehydrated state.
Regarding claim 34 and 35, where the hydrogel particles contain precursors that react to form a covalently crosslinked hydrogel, it appears the limitations are met.
Regarding claims 36 and 37, it would have been obvious to formulate the particles with shapes and sizes that were known to be suitable for implant systems, such as spherical particles with a size ranging from about 10 to about 500 microns, as taught by Campbell. 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). Further, it would have been well within the relative skills of the skilled artisan to routinely optimize the particle shapes and sizes for desired rate of release, syringe diameters, injection flowability, etc. See MPEP 2144.04(II)(A) and (B).
Regarding claim 38, it would have been obvious to select from an anesthetic as the neuromodulation agent, for the same reasons discussed above by Campbell.
Regarding claim 39, it would have been obvious to further include an additional therapeutic agent, where Campbell teaches a therapeutic agent, or agents, may be included, in order to formulate a system with desired therapeutic activity.
Regarding claim 40, where the claims are directed to an implant system, the limitation of wherein the neuromodulatory agent is released in a sustained manner due to delayed diffusion of water is tied to the intended use of the implant system, which would require the step of administering the implant system to form the depot for sustained release. Accordingly, where the implant system as instantly claimed is made obvious above and comprises the same components, and are suitable for forming a sustained release hydrogel depot, it appears the system would be capable of releasing the neuromodulatory agent in a sustained release manner by delayed diffusion of water into the depot for sustained release.
Claims 46, 48, and 49, are rejected under 35 U.S.C. 103 as being unpatentable over Campbell et al (US 20110142936 A1, hereinafter “Campbell”), as applied to claims 33-40 above, and further in view of Sershen et al (US 20170274082 A1, hereinafter “Sershen”).
Campbell is discussed above and further teaches the therapeutic agent may be mixed with the precursors (¶ 128). High water solubility drugs can be used (¶ 93).
The reference does not appear to specifically teach wherein the solid particles capable of forming a hydrogel depot specifically comprise the therapeutic agent.
Sershen teaches compositions comprising a plurality of hydrogel particles, wherein the dry particles can be loaded into a suitable carrier or delivery device (abs, ¶ 73). In one embodiment, the composition comprises dried particulate hydrogel particles comprising an anesthetic (e.g., lidocaine, bupivacaine, xylocaine, etc.), and are placed in an aqueous solution (¶ 80). The rehydrated slurry may be used to deliver the anesthetic to the target anatomy of interest wherein the drug release profile is dictated by the either the diffusion of the steroid out of the hydrogel, or the hydrolytic or enzymatic degradation of the hydrogel, or both (¶ 80). The hydrogel particles comprise precursor components (¶ 27). The hydrogel particles may be provided as dried, semi- or fully hydrated particles (¶ 67). The particles are sieved to achieve desired particle size (¶ 72).
Regarding claim 46, it would have been obvious to formulate a system comprising solid hydrogel particles, a neuromodulatory agent, and a carrier medium, as taught by Campbell above and for the same reasons. Further, where Campbell teaches the system is suitable for injection, it appears the carrier medium is capable of being injected.
Where Campbell teaches neuromodulatory agents, including anesthetics can be included in the hydrogels for sustained release, it would have been obvious to formulate the solid particles wherein the solid particles comprise the neuromodulatory agent made obvious above, as Sershen teaches solid particles capable of formulating a hydrogel were known to comprise an anesthetic agent for active agent release, in order to achieve a desired sustained release profile for intended therapeutic uses and activity.
Regarding the hydrogel depot capable of sustained delivery of the agent, where the claims are directed to an injectable implant system, and the system made obvious above comprises solid hydrogel particles, a neuromodulatory agent, and a carrier medium, capable of formulating a hydrogel implant capable of sustained active agent release, it appears the particles would be capable of forming a hydrogel depot capable of sustained delivery of the active, thereby meeting the intended use limitations.
Regarding claim 48, where the claims are directed to an injectable neuromodulating system, the limitation of wherein the neuromodulatory agent is released in a sustained manner due to delayed diffusion of water is tied to the intended use of the injectable neuromodulating system, which would require the step of administering the system to form the hydrogel depot capable of sustained release. Accordingly, where the system as instantly claimed is made obvious above and comprises the same components, and are suitable for forming a sustained release hydrogel, it appears the system would be capable of releasing the neuromodulatory agent in a sustained release manner by delayed diffusion of water into the hydrogel depot for sustained release.
Regarding claim 49, it would have been obvious to select from water soluble drugs, such as those with high water solubility, where these agents were known to be suitable for sustained release by Campbell, depending on desired release profiles from the resulting depots, and were Campbell teaches the rate of release from the hydrogel will depend on the properties of the drug, etc.
Further, where the claims are directed to an injectable neuromodulating system, the limitation of release >24 hours is tied to the intended use of the injectable system, which would require the step of administering the system to form the hydrogel depot capable of sustained release. Accordingly, where the system made obvious above comprises the same components as instantly claimed, are capable of sustained release of an active agent, it appears the system would be capable of forming a hydrogel depot with an active release of > 24 hours.
Claims 47 and 49 are rejected under 35 U.S.C. 103 as being unpatentable over Campbell et al (US 20110142936 A1, hereinafter “Campbell”) and Sershen et al (US 20170274082 A1, hereinafter “Sershen”) as applied to claims 46, 48, and 49 above, and further in view of Bright (WO 2019178564 A1, cited on IDS dated 12/15/2023).
Campbell and Sershen are discussed above but do not appear to teach the amount of active agent of claim 47. Further, while teaching systems capable of sustained release, purely arguendo, if somehow the systems are not capable of >24 hours release, the following applies.
Bright teaches in situ forming gel based compositions for sustained release of a therapeutic agent for neuromodulation, comprising solid hydrogel particles that can then be resuspended in an aqueous buffer with or without a drug and stored in a preloaded syringe for injection (abs, ¶¶ 9, 37, 183). The agent may be in the hydrogel, embedded in the hydrogel, or embedded in particles (micelles, nanoparticles, microparticles) from which it is released in a more sustained fashion (¶¶ 25, 183). Drug loaded hydrogel particles are disclosed (¶ 165). The hydrogels are formed via the reaction of precursors, and in embodiments, the hydrogel particles are covalently cross linked (¶¶ 153, 278). In embodiments, lyophilized precursors are mixed with a diluent (e.g., trilysine acetate buffer), and the accelerator (sodium phosphate buffer) is included in a separate syringe (¶ 160). A neurolytic agent may be loaded into the precursor phase (¶ 174). The neuromodulatory agents may have a sustained released from 1 day to 9 months (¶ 130). If the actives are additionally incorporated into microspheres, liposomes, or nanoparticles, their release rate can be delayed and can provide more sustained release (¶ 183). The drug loading level can be in some embodiments about 1% to 80% (¶ 260). In a particular embodiment, valproate-loaded chitosan nanoparticles were loaded up to 50% into a PEG-PLGA-PEG triblock hydrogel (¶ 279). In some embodiments, the drug release occurs as the hydrogel absorbs water after implantation causing solubilization of the hydrophobic drug crystal and subsequent sustained diffusion into the surrounding tissues (¶ 252). In embodiments, the hydrogel particles are 70 microns in diameter (¶ 278).
Regarding claim 47, where Bright teaches systems comprising solid hydrogel particles, neuromodulatory agents, and a carrier medium (i.e., the aqueous buffer), and teaches the drug loading levels can be from about 1 to 80%, it would have been obvious to modify the system made obvious above by including known amounts of neuromodulatory agents suitable for systems comprising hydrogel particles, neuromodulatory agents, and a carrier medium (i.e., the aqueous buffer) for sustained release of the active, such as from about 1 to about 80%. 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). Additionally, it would have been well within the relative skills of the skilled artisan to routinely adjust the amount of the active ingredient for various release profiles, therapeutic activity, the particular active agent, 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) and (B).
Regarding claim 49, while it appears that the limitation of sustained release that is tied to the intended use of the systems as instantly claimed is made obvious above, purely arguendo, if not, it would have been obvious to formulate a system for sustained release of the neuromodulatory agent from 1 day to 9 months, where Bright teaches systems for formulating hydrogel implants for sustained release of neuromodulatory agents can be formulated for 1 day to 9 month sustained release, depending on desired treatments, therapeutic activity, etc.
Claim 50 is rejected under 35 U.S.C. 103 as being unpatentable over Campbell et al (US 20110142936 A1, hereinafter “Campbell”) and Sershen et al (US 20170274082 A1, hereinafter “Sershen”) as applied to claims 46, 48, and 49 above, and further in view of Rizzi et al (US 20150247119 A1, hereinafter “Rizzi”), as evidenced by Lanao et al (Tissue Engineering, 2013, vol 19, no. 4, pp-380-390, hereinafter “Lanao”).
Campbell is discussed above and further teaches high water soluble drugs may be loaded within microparticles, e.g., PLGA, including microparticles having a hydrophobic nature, to control the rate of release from the hydrogel (¶¶ 92, 93, 97). As evidenced by Lanao, PLGA is a hydrophobic polymer (pg 383 2nd col 1st ¶).
Campbell and Sershen are discussed above but do not specifically teach suspension with precursor melt particles.
Rizzi is discussed above.
Regarding claim 50, it would have been obvious to encapsulate the agent made obvious above in a hydrophobic secondary polymer, such as PLGA, as taught by Campbell, in order to achieve a desired release profile for the intended use of the system.
Regarding the limitation of encapsulated for suspension within precursor melt particles, it would have been obvious to formulate the encapsulated agent within solid precursor particles, where solid precursor particles comprising an active agent for systems suitable for hydrogel formation, were known from Rizzi.
Additionally, the limitation of suspension within precursor melt particles appears to be a product by process limitation, and where solid precursor particles comprising the encapsulated agent is made obvious above, it appears the limitation is met. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. Therefore, the method of formulating precursor particles comprising encapsulated agent does not distinguish the compositions from that of the prior art.
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 33-40, and 46-50, are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 11,154,547 B2, hereinafter referred to as ‘547, in view of Campbell et al (US 20110142936 A1, hereinafter “Campbell”), Sershen et al (US 20170274082 A1, hereinafter “Sershen”), Bright (WO 2019178564 A1, cited on IDS dated 12/15/2023), and Rizzi et al (US 20150247119 A1, hereinafter “Rizzi”). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘547 disclose a method of modulating inflammation in a patient comprising an injectable in situ forming hydrogel slurry.
The claims of ‘547 do not disclose a neuromodulating agent as instantly claimed, solid particulate hydrogel particles nor their size, sustained release, the loading of the agent, nor wherein the agent is encapsulated in a secondary hydrophobic polymer in precursor melt particles.
Bright is discussed above and further teaches neuromodulating agents that can be used in treatments to reduce inflammation (¶¶ 37, 98).
Campbell, Sershen, Bright, and Rizzi, are discussed above.
It would have been obvious to formulate the injectable in situ formulating hydrogel slurry of ‘547 with solid hydrogel particles in a carrier medium, which are taught to be suitable for hydrogel formation by Campbell and Sershen for the same reasons discussed above.
It would have been obvious to include known active agents suitable for injectable hydrogel systems for reducing inflammation, including neuromodulating agents, as taught by Bright.
It would have been obvious to include an anesthetic, where anesthetics were known to be suitable for implant systems for reducing inflammation, as taught by Bright.
It would have been obvious to include known hydrogel particle shapes and sizes known to be suitable for systems that are suitable for forming hydrogels, such as spherical particles with a size ranging from about 10 to about 500 microns, as taught by Campbell.
Where the claims of ‘547 are directed to administrating an active agent to modulate inflammation, it would have been obvious to formulate a system capable of sustained release of the active agent, in order to provide a therapeutic effect over a prolonged period of time, as taught by Campbell.
It would have been obvious to use known loading amounts of active agents suitable for injectable systems that are capable of hydrogel formation, such as those taught by Bright above and for the same reasons.
It would have been obvious to encapsulate the agent in a secondary hydrophobic polymer included in a reactive precursor particle, for the same reasons discussed above by Campbell and Rizzi.
Claims 33-40, and 46-50, are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 12,029,733 B2, hereinafter referred to as ‘733, in view of Campbell et al (US 20110142936 A1, hereinafter “Campbell”), Sershen et al (US 20170274082 A1, hereinafter “Sershen”), Bright (WO 2019178564 A1, cited on IDS dated 12/15/2023), and Rizzi et al (US 20150247119 A1, hereinafter “Rizzi”). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘733 disclose a method of modulating hypertension comprising an injectable in situ forming hydrogel slurry being for delivering a therapeutic agent.
The claims of ‘733 do not disclose a neuromodulating agent as instantly claimed, solid particulate hydrogel particles nor their size, sustained release, the loading of the agent, nor wherein the agent is encapsulated in a secondary hydrophobic polymer in precursor melt particles.
Bright is discussed above and further teaches neuromodulation may be used to treat hypertension (¶¶ 57, 128).
Campbell, Sershen, Bright, and Rizzi, are discussed above.
It would have been obvious to formulate the injectable in situ formulating hydrogel slurry of ‘733 with solid hydrogel particles in a carrier medium, which are taught to be suitable for hydrogel formation by Campbell and Sershen for the same reasons discussed above.
It would have been obvious to include known active agents suitable for injectable hydrogel systems for modulating hypertension, including neuromodulating agents, as taught by Bright.
It would have been obvious to include an anesthetic, where anesthetics were known to be suitable for implant systems, as taught by Bright, depending on the desired therapeutic effect.
It would have been obvious to include known hydrogel particle shapes and sizes known to be suitable for systems that are suitable for forming hydrogels, such as spherical particles with a size ranging from about 10 to about 500 microns, as taught by Campbell.
Where the claims of ‘733 are directed to administrating an active agent to modulate hypertension, it would have been obvious to formulate a system capable of sustained release of the active agent, in order to provide a therapeutic effect over a prolonged period of time, as taught by Campbell.
It would have been obvious to use known loading amounts of active agents suitable for injectable systems that are capable of hydrogel formation, such as those taught by Bright above and for the same reasons.
It would have been obvious to encapsulate the agent in a secondary hydrophobic polymer included in a reactive precursor particle, for the same reasons discussed above by Campbell and Rizzi.
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