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 .
Withdrawn Objections/Rejections
The rejections of claims 2, 7, and 14 are withdrawn in view of the cancellation of the claims.
The rejections of claims 1, 3, 6, 9, 11-13, and 18-20 under 35 U.S.C. § 112(a) as failing to comply with the written description requirement are withdrawn in view of the claim amendments.
The rejections of claims 1, 3, 6, 9, 11-13, and 18-20 under 35 U.S.C. § 112(b) are withdrawn in view of the claim amendments.
Claim Status
Applicants' amendments and arguments filed on 07/09/2026 have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claims 2, 4-5, 7-8, 10, and 14 are cancelled.
Claims 21-27 are newly added.
Claims 1, 3, 6, 9, 11-13, and 15-27 are pending and under current examination. The claims were read in view of the species election in the reply filed on 03/20/2026 of the species of hydrophobic monomer of n-butylmethacrylate, charged monomer of 2-(diethylamino)ethyl methacrylate, and templating agent of poly(2-acrylamido-2-methyl-1-propanesulfonic acid).
New Rejections Necessitated by Claim Amendments
Claim Rejections - 35 USC § 112(b)
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.
Claim 27 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 27 lacks a period, rendering the full scope of the claim uncertain. Claims should be in the form of a single sentence (see MPEP 608.01(m)).
Rejections Maintained, Modified to Address Amended Claims and Newly Added Claims 21 and 25-27
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, 3, 6, 9, 11-13, 18-21, and 25-27 are rejected under 35 U.S.C. 103 as being unpatentable over Xu et al. (WO 2017/173453 A1; published October 5, 2017; of record), hereafter “Xu”, in view of Richard et al. (US 2009/0169471 A1, published July 2, 2009; of record), hereafter “Richard”.
Regarding instant claims 1, 3, 9, and 26-27, Xu teaches stimuli responsive amphiphilic polymers with a hydrophobic portion which self-assemble to form nanoparticles which can be used to release cargo to target cells, tissues, or organs (abstract; claims 1-2). Polymers may be arranged as a block copolymer (pg. 14, lines 16-25), and the polymers are taught to have blocks of hydrophilic and hydrophobic polymers (pg. 4, lines 9-11). The stimuli are selected from pH, temperature, light, redox change, over-expressed enzymes, hypoxia, sound, magnetic force, electrical energy, and combinations thereof (pg. 2, lines 27-33) and stimuli, such as by the internal physiological environment, can affect the sol-gel transition (pg. 23, lines 21-29). The nanoparticles can be designed for release in the tumor microenvironment which has a more acidic pH and elevated temperature compared to normal tissue (pg. 78-80, “1. Tumor targeting”). Xu teaches that the inclusion of temperature dependent polymers can promote the changing of the microstructure, turning it into a gel (pg. 27, lines 6-9), and hydrophobic monomers of butyl methacrylate can be included (pg. 27, lines 22-24). Temperature sensitive monomers can be combined with pH sensitive monomers (pg. 28, lines 17-21), and examples of ionic pH-sensitive polymers include the elected poly(2-diethylaminoethyl methacrylate) (PDEAEMA) (pg. 25, lines 12-30). Xu teaches that compounds and pharmaceutical compositions thereof can be administered in an aqueous solution by parenteral injection (pg. 68, lines 4-10). As the polymers of Xu are taught to turn into a gel in response to stimuli such as temperature, and the physiological environment can affect the sol-gel transition, it is interpreted that the aqueous solutions of Xu are capable of functioning as an embolic composition.
Regarding the limitation “wherein the aqueous liquid embolic composition embolizes tissue upon delivery into one or more blood vessels feeding the tissue”, this is a future intended use of the claimed composition which, absent evidence to the contrary, does not further structurally limit the claimed composition. However, as noted above, the polymers of Xu are taught to turn into a gel in response to stimuli such as temperature, and the physiological environment can affect the sol-gel transition; Xu teaches the administration of aqueous compositions via parenteral injection, which is inclusive of intravascular injection (pg. 71, lines 30-32). It is therefore interpreted that the compositions of Xu are capable of performing the intended use of embolizing tissue upon delivery into one or more blood vessels feeding the tissue.
Regarding instant claim 6, Xu teaches that the nanoparticles contain a hydrophobic inner core and hydrophilic outer shell which gives the ability to load therapeutic agents (abstract). Xu teaches a variety of cargos, including neutral anti-cancer agents (pg. 89, line 15-pg. 90, line 9).
Regarding instant claim 11, the limitation “the composition becomes a gel when injected into a vasculature of a patient” is a future intended use of the claimed composition which, absent evidence to the contrary, does not further structurally limit the claimed composition. However, as noted above, the polymers of Xu are taught to turn into a gel in response to stimuli such as temperature, and the physiological environment can affect the sol-gel transition; Xu teaches the administration of aqueous compositions via parenteral injection, which is inclusive of intravascular injection (pg. 71, lines 30-32). It is therefore interpreted that the compositions of Xu are capable of performing the intended use of becoming a gel when injected into a vasculature of a patient.
Regarding instant claim 12, Xu teaches that polymers may be arranged as a block copolymer, and may have two distinct blocks (a diblock copolymer) (pg. 14, lines 16-25).
Regarding instant claims 18-21 Xu teaches that pharmaceutical compositions can be for administration by parenteral injection routes (see pg. 67-72, “IV. Formulations and Methods of Administration”), suggesting the compositions and components thereof are contained in a syringe. Xu further teaches that the formulations can be administered in multiple doses (pg. 72, lines 5-9).
Regarding the inclusion of a templating agent, Xu further suggests the inclusion of electric field-sensitive polymers such as naturally occurring polymers such as chitosan, alginate, and hyaluronic acid, as well as poly(2-acrylamido-2-methylpropane sulphonic acid-co-n-butylmethacrylate) (pg. 30, line 22-pg. 31, line 12). However, Xu does not explicitly teach the elected templating agent of poly(2-acrylamido-2-methyl-1-propanesulfonic acid) (instant claims 1, 13, 18, 25, and 27). Xu further does not explicitly teach that the aqueous composition is provided in a syringe (instant claim 21), nor a kit comprising a syringe containing the block copolymer and the templating agent contained within a separate delivery vessel of a second syringe containing the templating agent (instant claims 18-20).
Richard teaches injectable particles containing a particle-forming polymer and a pore-filling composition including a therapeutic agent and at least one pore-filling polymer (abstract). The particles are administered to effect embolization, which can be used in the controlled, selective obliteration of the blood supply to tumors (paragraphs [0074]-[0075], [0077]). Pore-filling polymers are selected based on their ability to modulate the release of the therapeutic agents from the particles (paragraph [0031]).
Pore-filling polymers can be charged, particularly in order to take advantage of electrostatic interactions with charged therapeutic agents, an example of which include salts of poly(2-acrylamido-2-methyl-1-propanesulfonic acid) (paragraphs [0036]-[0037]). Richard further teaches that the pore-filling polymer may be introduced after particle formation, and that particles and additional agents may be stored and transported in dry or wet form in the form of a kit and may be shipped, for example in a syringe; this allows for the concentration of the composition to be varied as desired by the health care practitioner (paragraphs [0065]-[0069]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective date of the instant invention to incorporate the salts of poly(2-acrylamido-2-methyl-1-propanesulfonic acid) suggested by Richard in the compositions of Xu. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success in order to incorporate a charged polymer that can modulate the release of therapeutic agents from polymer particles used in embolic compositions for tumor treatment, as suggested by Richard. There is a reasonable expectation of success as Xu teaches polymer particles capable of gelling and releasing therapeutic agents in response to stimuli, such as those provided by a tumor microenvironment (pg. 78-80, “1. Tumor targeting”), contemplates the incorporation of poly(2-acrylamido-2-methylpropane sulphonic acid-containing polymers (pg. 31, lines 11-12), and suggests controlling the rate of cargo release (abstract).
It would further have been prima facie obvious to one of ordinary skill in the art before the effective date of the instant invention to package the block copolymer and templating agent in syringes in a kit, as suggested by Richard. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success in order to package and transport the components in a form that allows for a health care provider to administer a desired concentration, as suggested by Richard. There is a reasonable expectation of success, as Xu teaches administration by injection and that compositions can by formulated in dosage forms appropriate for the route of administration (pg. 68, lines 4-8).
Claims 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Xu et al. (WO 2017/173453 A1; published October 5, 2017; of record), hereafter “Xu”.
Regarding instant claim 15, Xu teaches stimuli responsive amphiphilic polymers with a hydrophobic portion which self-assemble to form nanoparticles which can be used to release cargo to target cells, tissues, or organs (abstract; claims 1-2). Polymers may be arranged as a block copolymer (pg. 14, lines 16-25), and the polymers are taught to have blocks of hydrophilic and hydrophobic polymers (pg. 4, lines 9-11). The stimuli are selected from pH, temperature, light, redox change, over-expressed enzymes, hypoxia, sound, magnetic force, electrical energy, and combinations thereof (pg. 2, lines 27-33) and stimuli, such as by the internal physiological environment, can affect the sol-gel transition (pg. 23, lines 21-29). The nanoparticles can be designed for release in the tumor microenvironment which has a more acidic pH and elevated temperature compared to normal tissue (pg. 78-80, “1. Tumor targeting”). Xu teaches that the inclusion of temperature dependent polymers can promote the changing of the microstructure, turning it into a gel (pg. 27, lines 6-9), and hydrophobic monomers of butyl methacrylate can be included (pg. 27, lines 22-24). Temperature sensitive monomers can be combined with pH sensitive monomers (pg. 28, lines 17-21), and examples of ionic pH-sensitive polymers include the elected poly(2-diethylaminoethyl methacrylate) (PDEAEMA) (pg. 25, lines 12-30). Xu teaches that compounds and pharmaceutical compositions thereof can be administered in an aqueous solution by parenteral injection (pg. 68, lines 4-10). As the polymers of Xu are taught to turn into a gel in response to stimuli such as temperature, and the physiological environment can affect the sol-gel transition, it is interpreted that the aqueous solutions of Xu are capable of functioning as an embolic composition.
Regarding the limitation “wherein the aqueous liquid embolic composition embolizes tissue upon delivery into one or more blood vessels feeding the tissue”, this is a future intended use of the claimed composition which, absent evidence to the contrary, does not further structurally limit the claimed composition. However, as noted above, the polymers of Xu are taught to turn into a gel in response to stimuli such as temperature, and the physiological environment can affect the sol-gel transition; Xu teaches the administration of aqueous compositions via parenteral injection, which is inclusive of intravascular injection (pg. 71, lines 30-32). It is therefore interpreted that the compositions of Xu are capable of performing the intended use of embolizing tissue upon delivery into one or more blood vessels feeding the tissue.
Regarding instant claim 16, the limitation “the composition becomes a gel when injected into a vasculature of a patient” is a future intended use of the claimed composition which, absent evidence to the contrary, does not further structurally limit the claimed composition. However, as noted above, the polymers of Xu are taught to turn into a gel in response to stimuli such as temperature, and the physiological environment can affect the sol-gel transition, Xu teaches the administration of aqueous compositions via parenteral injection, which is inclusive of intravascular injection (pg. 71, lines 30-32). It is therefore interpreted that the compositions of Xu are capable of performing the intended use of becoming a gel when injected into a vasculature of a patient.
Regarding instant claim 17, Xu teaches that polymers may be arranged as a block copolymer, and may have two distinct blocks (a diblock copolymer) (pg. 16, lines 14-25).
Xu does not teach the claimed block copolymer with sufficient specificity to anticipate, but rather renders obvious the instant claims. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to combine the prior art elements suggested by Xu of a di-block copolymer, hydrophobic monomers of butyl methacrylate, and ionic pH-sensitive monomers of poly(2-diethylaminoethyl methacrylate) according to known methods to yield predictable results. As noted above, Xu teaches that nanoparticles can be designed for release in the tumor microenvironment which has a more acidic pH and elevated temperature compared to normal tissue (pg. 78-80, “1. Tumor targeting”), and teaches the combination of temperature sensitive polymers (including butyl methacrylate monomers) and pH-sensitive polymers (including PDEAEMA).
Rearrangement of the prior art elements taught by Xu to reach the composition of the instant claims is within the purview of a person of ordinary skill in the art who is not an automaton and would predictably result in a composition that responds to temperature and pH stimuli for cargo delivery to the tumor microenvironment. Further, from MPEP 2141 I., "[I]n Sakraida v. AG Pro, Inc., the Court derived…the conclusion that when a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious." Id. at 417, 82 USPQ2d at 1395-96 (Internal quotations omitted.)”.
Rejections of Newly Added Claims 22-24
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 22-24 are rejected under 35 U.S.C. 103 as being unpatentable over Xu as applied to claims 15-17 above, and further in view of Richard et al. (US 2009/0169471 A1, published July 2, 2009; of record), hereafter “Richard”.
The teachings of Xu are set forth above. Regarding the inclusion of a templating agent, Xu further suggests the inclusion of electric field-sensitive polymers such as naturally occurring polymers such as chitosan, alginate, and hyaluronic acid, as well as poly(2-acrylamido-2-methylpropane sulphonic acid-co-n-butylmethacrylate) (pg. 30, line 22-pg. 31, line 12). Regarding instant claim 24, Xu teaches that pharmaceutical compositions can be for administration by parenteral injection routes (see pg. 67-72, “IV. Formulations and Methods of Administration”), suggesting the compositions and components thereof are contained in a syringe. Xu further teaches that the formulations can be administered in multiple doses (pg. 72, lines 5-9).
However, Xu does not explicitly teach the elected templating agent of poly(2-acrylamido-2-methyl-1-propanesulfonic acid) (instant claims 22-23), or that the liquid embolic composition is provided in a syringe (instant claim 24).
Richard teaches injectable particles containing a particle-forming polymer and a pore-filling composition including a therapeutic agent and at least one pore-filling polymer (abstract). The particles are administered to effect embolization, which can be used in the controlled, selective obliteration of the blood supply to tumors (paragraphs [0074]-[0075], [0077]). Pore-filling polymers are selected based on their ability to modulate the release of the therapeutic agents from the particles (paragraph [0031]).
Pore-filling polymers can be charged, particularly in order to take advantage of electrostatic interactions with charged therapeutic agents, an example of which include salts of poly(2-acrylamido-2-methyl-1-propanesulfonic acid) (paragraphs [0036]-[0037]). Richard further teaches that the pore-filling polymer may be introduced after particle formation, and that particles and additional agents may be stored and transported in dry or wet form in the form of a kit and may be shipped, for example in a syringe; this allows for the concentration of the composition to be varied as desired by the health care practitioner (paragraphs [0065]-[0069]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective date of the instant invention to incorporate the include salts of poly(2-acrylamido-2-methyl-1-propanesulfonic acid) suggested by Richard in the compositions of Xu. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success in order to incorporate a charged polymer that can modulate the release of therapeutic agents from polymer particles used in embolic compositions for tumor treatment, as suggested by Richard. There is a reasonable expectation of success as Xu teaches polymer particles capable of gelling and releasing therapeutic agents in response to stimuli, such as those provided by a tumor microenvironment (pg. 78-80, “1. Tumor targeting”), contemplates the incorporation of poly(2-acrylamido-2-methylpropane sulphonic acid-containing polymers (pg. 31, lines 11-12), and suggests controlling the rate of cargo release (abstract).
It would further have been prima facie obvious to one of ordinary skill in the art before the effective date of the instant invention to package the block copolymer composition in syringes in a kit, as suggested by Richard. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success in order to package and transport the components in a form that allows for a health care provider to administer a desired concentration, as suggested by Richard. There is a reasonable expectation of success, as Xu teaches administration by injection and that compositions can by formulated in dosage forms appropriate for the route of administration (pg. 68, lines 4-8).
Double Patenting Rejections, Modified to Address Newly Added Claims 21-27
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 3, 6, 9, 11-13, and 15-27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 13-15, and 18-20 of copending Application No. 18/618,015 in view of Xu et al. (WO 2017/173453 A1; published October 5, 2017; of record), hereafter “Xu”.
Both the instant claims and those of co-pending Application No. 18/618,015 recite an aqueous liquid embolic composition comprising a di-block or tri-block copolymer including a hydrophobic block and a charged block and a templating agent including the same components, including the elected poly(2-acylamido-2-methyl-1-propanesulfonic acid) (compare instant claim 13 to copending claim 15). The compositions of both sets of claims are recited to become a gel when injected into a vasculature of a patient and include a di-block copolymer. Both sets of claims further recite a kit for embolization comprising a syringe containing a block copolymer including a hydrophobic block and a charged block and a second syringe containing the templating agent (compare instant claims 18-20 to copending claims 18-20).
The claims of copending Application No. 18/618,015 do not recite that the hydrophobic block includes the elected n-butyl methacrylate monomer or that the charged block includes the elected 2-(diethylamino)ethyl methacrylate monomer. The copending claims further do not recite that the hydrophobic monomer block forms a permanent micelle configured to be loaded with a neutral drug.
Xu teaches stimuli responsive amphiphilic polymers with a hydrophobic portion which self-assemble to form nanoparticles which can be used to release cargo to target cells, tissues, or organs (abstract; claims 1-2). Polymers may be arranged as a block copolymer (pg. 14, lines 16-25), and the polymers are taught to have blocks of hydrophilic and hydrophobic polymers (pg. 4, lines 9-11). The stimuli are selected from pH, temperature, light, redox change, over-expressed enzymes, hypoxia, sound, magnetic force, electrical energy, and combinations thereof (pg. 2, lines 27-33) and stimuli, such as by the internal physiological environment, can affect the sol-gel transition (pg. 23, lines 21-29). The nanoparticles can be designed for release in the tumor microenvironment which has a more acidic pH and elevated temperature compared to normal tissue (pg. 78-80, “1. Tumor targeting”). Xu teaches that the inclusion of temperature dependent polymers can promote the changing of the microstructure, turning it into a gel (pg. 27, lines 6-9), and hydrophobic monomers of butyl methacrylate can be included (pg. 27, lines 22-24). Temperature sensitive monomers can be combined with pH sensitive monomers (pg. 28, lines 17-21), and examples of ionic pH-sensitive polymers include the elected poly(2-diethylaminoethyl methacrylate) (PDEAEMA) (pg. 25, lines 12-30). Xu teaches that the nanoparticles contain a hydrophobic inner core and hydrophilic outer shell which gives the ability to load therapeutic agents (abstract). Xu teaches a variety of cargos, including neutral anti-cancer agents (pg. 89, line 15-pg. 90, line 9).
It would have been prima facie obvious to one of ordinary skill in the art to modify the block copolymer of co-pending Application 18/618,015 with the butyl methacrylate monomers and PDEAMA monomers capable of forming a nanoparticle with a hydrophobic inner core, as suggested by Xu. One of ordinary skill in the art would have been motivated to do so to achieve a composition that responds to temperature and pH stimuli for cargo delivery to the tumor microenvironment.
Given that the subject matter of the instant claims is obvious and substantially overlaps the subject matter of copending Application No. 18/618,015, the instant claims are rejected on the ground of nonstatutory double patenting. This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant’s arguments filed 07/09/2026 have been fully considered.
Regarding the claim rejections under 35 USC § 103, Applicant argues that in contrast to Xu, the presently claimed invention is directed to aqueous liquid embolic compositions and kits for embolization which are the antithesis of the compositions of Xu, which provide stimuli-responsive solid polymeric nanoparticles (NPs) that have high stability in the circulatory system in vivo. Embolic compositions block blood flow when delivered and are far removed from NPs having high stability in the circulatory system in vivo as described in Xu. To further emphasize this distinction, claims 1 and 15 have been amended to recite that the claimed aqueous liquid embolic compositions act to embolize tissue upon delivery into one or more blood vessels feeding the tissue. Applicant argues that Richard does not make up for this deficiency in Xu.
These arguments are unpersuasive. As detailed in the above rejections, Xu renders obvious an aqueous composition comprising a block copolymer comprising monomers consistent with those instantly claimed. Xu further teaches the inclusion of temperature dependent polymers to promote the changing of the microstructure, turning it into a gel (pg. 27, lines 6-9), that the nanoparticles can be designed for release in the tumor microenvironment which has a more acidic pH and elevated temperature compared to normal tissue (pg. 78-80, “1. Tumor targeting”), and that stimuli, such as by the internal physiological environment, can affect the sol-gel transition of the polymers (pg. 23, lines 21-29). This is consistent with the description of embolic compositions in the instant specification at paragraph [0036], “In some instances, example embolic compositions may include liquid compositions that form a gel material (also referred to herein as a hydrogel material or a solidified material) in situ upon injection into the body. Such liquid compositions include liquid compositions that are capable of gel formation in response to in vivo conditions. In some instances, the liquid compositions may form gels in response to a change in pH and/or a change in temperature.”
Further, the newly recited limitations of instant claims 1 and 15 “wherein the aqueous liquid embolic composition embolizes tissue upon delivery into one or more blood vessels feeding the tissue” is a future intended use of the claimed composition which, absent evidence to the contrary, does not further structurally limit the claimed composition. As the structural components of the compositions of the instant claims are rendered obvious by the teachings of the prior art, it is interpreted that the compositions are capable of performing the recited intended uses of embolizing tissue upon delivery into one or more blood vessels feeding the tissue. See also MPEP 2112.01 II, “A chemical composition and its properties are inseparable.”
Regarding the nonstatutory double patenting rejections over claims 1, 13-15, and 18-20 of copending Application No. 18/618,015 in view of Xu, Applicant requests that the rejection be held in abeyance until the claims are otherwise in condition for allowance.
In response, the Examiner notes that a request to hold a rejection in abeyance is not a proper
response to a rejection. Rather, a request to hold a matter in abeyance may only be made in response to
an OBJECTION or REQUIREMENTS AS TO FORM (see MPEP 37 CFR 1.111(b) and 714.02). As set forth in
the above rejections, the instant claims are rejected on the ground of obvious-type nonstatutory double patenting as being unpatentable over the claims of copending Application No. 18/618,015 in view of Xu.
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 JUDITH M KAMM whose telephone number is (703)756-4575. The examiner can normally be reached M-F 8:00 am-4:30 pm EST.
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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
/J.M.K./Examiner, Art Unit 1611
Prosecution Insights