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 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) in the reply filed on 03/20/2026 is acknowledged.
Claims 4-5, 8, and 10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03/20/2026.
Claims 1-3, 6-7, 9, and 11-20 are under current examination.
Priority
Priority has been claimed to US PRO 63/492,382, filed 03/27/2023.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 06/17/2024 and 08/07/2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the Examiner.
Claim Rejections - 35 USC § 112(a)-Written Description
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.
Claims 1-3, 6-7, 9, 11-14, 18-20 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. The claims 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, at the time the application was filed, had possession of the claimed invention.
The instant application does not sufficiently describe the invention as it relates to “a templating agent”.
In Regents of the University of California v. Eli Lilly & Co. 43 USPQ2d 1398, the court stated:
A written description of an invention involving a chemical genus, like a description of a chemical
species, “requires a precise definition, such as by structure, formula, [or] chemical name,” of the
claimed subject matter sufficient to distinguish it from other materials. Fiers, 984 F.2d at 1171, 25 USPQ2d at 1606; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284-85 (CCPA 1973) (“In
other cases, particularly but not necessarily, chemical cases, where there is unpredictability in
performance of certain species or subcombinations other than those specifically enumerated,
one skilled in the art may be found not to have been placed in possession of a genus. . . .”).
Further, MPEP 2163 requires a known or disclosed correlation between function and structure
to show that the inventor was in possession of the claimed invention. Per MPEP 2163 (emphasis added)
“An applicant may also show that an invention is complete by disclosure of sufficiently detailed, relevant
identifying characteristics which provide evidence that inventor was in possession of the claimed
invention, i.e., complete or partial structure, other physical and/or chemical properties, functional
characteristics when coupled with a known or disclosed correlation between function and structure, or
some combination of such characteristics. Enzo Biochem, 323 F.3d at 964, 63 USPQ2d at 1613 (quoting
the Written Description Guidelines, 66 Fed. Reg. at 1106, n. 49, stating that "if the art has established a
strong correlation between structure and function, one skilled in the art would be able to predict with a
reasonable degree of confidence the structure of the claimed invention from a recitation of its
function".). "Thus, the written description requirement may be satisfied through disclosure of function
and minimal structure when there is a well-established correlation between structure and
function." Id.”
Here, the claims recite the functional characteristic of a templating agent; the claims do not define what the agent is templating, and the specification does not define the effect on the composition an agent must possess in order to meet the limitation of a “templating agent”. The specification does not provide guidance to determine compounds which fulfill this description, as any compound present in the composition could, to some extent, influence the structure of the composition and thus act as a templating agent; the genus of “templating agent” therefore encompasses a nearly infinite number of highly variant compounds.
The claims lack written description because there is no disclosure of a correlation between function and structure of the templating agents in the specification, nor evidence of strong correlation established in the art. In addition, based on the functional characteristics recited by the instant claims, the instant claims would include compounds discovered at a later date. Given the potentially limitless scope of the compounds encompassed by the instant claims, Applicant cannot reasonably be said to have been in possession of each and every compound encompassed by the generic claims, each and every templating agent. Accordingly, the present specification fails to provide adequate written description for the genus of claims and does not reasonably convey to one skilled in the relevant art that the inventor, at the time the application was filed, had possession of the entire scope of the claimed invention.
It is suggested that Applicant can limit the templating agent to one or a combination of those set forth in paragraph [0050] of the specification.
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.
Claims 1-3, 6-7, 9, 11-14, and 18-20 are 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 1 recites the limitations "the polyanionic block" and “the polycationic block” in line 4. There is insufficient antecedent basis for these limitations in the claim, as the claim previously recites “a hydrophobic monomer block” and “a charged block”, but no polyanionic or polycationic block. It is unclear if the claim requires the presence of a polyanionic block and/or a polycationic block.
Claims 2-3, 6-7, 9, and 11-14 are rejected under 35 U.S.C. 112(b) by virtue of their dependency on indefinite claim 1 and failure to cure the deficiency noted above.
Claim 18 recites “A kit for embolization, the kit comprising: a syringe containing a block copolymer…; and a templating agent”. It is unclear if the claim requires that the templating agent is present in the syringe containing the block copolymer or merely requires that the templating agent is present in the kit. Claim 19 recites that the templating agent is “disposed within” the syringe; it is unclear if this is intended to be a further and distinct limitation on a syringe “containing” the templating agent or intended to indicate that the templating agent is contained in the syringe along with the block copolymer.
Claim 20 is rejected under 35 U.S.C. 112(b) by virtue of its dependency on indefinite claim 19 and failure to resolve the ambiguities noted above.
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, 6-7, 9, 11-14, and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Xu et al. (WO 2017/173453 A1; published October 5, 2017), hereafter “Xu”, in view of Richard et al. (US 2009/0169471 A1, published July 2, 2009), hereafter “Richard”.
Regarding instant claims 1-3, 7, and 9, 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 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. 16, lines 14-25).
Regarding instant claims 18-20 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, and 18), which includes one or more cations or anions (instant claim 14). Xu further does not explicitly teach a kit comprising a syringe containing the block copolymer, the templating agent, and 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 examples 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 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), 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 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. 14, lines 16-25).
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.)”.
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 1-3, 6-7, 9, and 11-20 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), 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 a di-block or tri-block copolymer including a hydrophobic block and a charged block and a 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.
Conclusion
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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
/J.M.K./Examiner, Art Unit 1611
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