DETAILED ACTION
Receipt is acknowledged of applicant’s Amendment/Remarks filed March 3, 2026.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on March 3, 2026 has been entered.
Status of the Claims
Claims 1, 10 and 11 have been amended. Claims 7-9 are cancelled. Claim 33 is newly added. Accordingly, claims 1-6 and 10-33 remain pending in the application. Claims 16-31 stand withdrawn from further consideration, with traverse. Claims 1-6, 10-15, 32 and 33 are currently under examination.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-6, 10-15, 32 and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Cleek et al. US 2014/0072514 A1, Mar. 13, 2014, hereafter as “Cleek”).
The claimed invention is drawn to a porous material comprising: a plurality of filamentous structures comprising a fluorinated copolymer with a tetrafluoroethylene moiety and a vinyl moiety having at least one functional group selected from acetate, alcohol, amine, and amide, the filamentous structures cooperating to define a plurality of macropores having an average diameter greater than 1 µm and accounting for at least 20% void volume, wherein the fluorinated copolymer is one of poly(tetrafluoroethylene-co-vinyl acetate) (TFE-VAc) and poly(tetrafluoroethylene-co-vinyl alcohol) (TFE-VOH), and wherein the fluorinated copolymer has a tetrafluoroethylene moiety mole content of 15.5% to 23.5% and a vinyl moiety mole content of 76.5% to 84.5%.
Regarding instant claim 1, Cleek teaches fluorinated copolymers, such as PTFE copolymers, dissolved in low toxicity solvents that enable the creation of stable water-in-solvent emulsions comprising the fluorinated copolymers dissolved in the low toxicity solvents and an optional hydrophilic agent (e.g., a therapeutic agent) dissolved in an aqueous solvent (e.g., water or saline) (abstract; [0007]). Cleek teaches the tetrafluoroethylene (TFE) copolymers include copolymers of TFE with functional monomers that comprise acetate, alcohol, amine or amide functional groups, as well as combinations thereof such as the particular TFE copolymers, poly(tetrafluoroethylene-vinyl acetate) (TFE-VAc) and (poly(tetrafluoroethylene-co-vinyl alcohol (TFE-VOH) ([0009] and [0039]). Cleek teaches that the PTFE copolymers comprise at least about 77 mole % of organic functional groups comprising acetate, alcohol, amine, or amide, or combinations thereof, and at least about 15 mole % of TFE and exemplify particular VAc mole percentages ranging from 76.5-84.5 mole % and particular TFE mole percentages ranging from 15.5-23.5 mole % ([0059]; Table 3). Cleek teaches that the water-in-solvent emulsion can comprise up to 1%, up to 5%, up to 10% of any other percentage by weight of said fluorinated copolymers that is suitable based on the particular copolymer selected, and can further comprise up to 0.1% up to 0.5%, up to 1%, up to 5%, up to 10%, up to 25%, up to 35%, up to 45%, or any other percentage by weight of said fluorinated copolymers that is suitable, dependent on the particular water soluble agent selection ([0059]). Cleek further teaches “low toxicity solvents” include “Class III Solvents” such as acetic acid, isopropyl acetate, acetone, methyl acetate, 1-butanol, 3-methyl-1-butanol, 2-butanol, methylethyl ketone, butyl acetate, methylisobutyl ketone, dimethyl sulfoxide, 2-methyl-1-propanol, ethanol, 1-pentanol, ethyl acetate, 1-propanol, ethyl formate, 2-propanol, formic acid, propyl acetate, isobutyl acetate, methyl acetate and further exemplifies the particular solvents, acetone, dimethyl sulfoxide, propylene glycol, acetonitrile, dioxane, formamide, dimethylformamide, pyridine, NMP, methylpyrrolidone, dimethylacetamide, ethylene glycol, methyoxymethanol, pyridine, piperidine, sulfolane, tetrahydrofuran, trichloroacetic acid, polyethylene glycol, and polyethylene oxide ([0047]; Table 1). Cleek teaches applying the emulsion to a substrate (e.g., a medical device, a living organ, or a living tissue) via a single spray nozzle such as a needle, catheter, syringe, dispensing tip, pipet, etc.) ([0062]-[0063]). Cleek further teaches once the emulsion is applied, it will harden and defines “harden” to refer to the solvent phase diffusing out of the extruded emulsion and/or non-solvent, such as water, aqueous solvents, saline, bodily fluids such as blood and sera, infusing into the extruded emulsion ([0067]).
Cleek is silent to “filamentous structures” and wherein the filamentous structures cooperate to define a plurality of macropores having an average diameter greater than 1 micron and accounting for at least 20% void volume.
The instant specification teaches a liquid composition comprising a fluorinated copolymer (e.g., TFE-VAc or TFE-VOH) dissolved or emulsified in a biocompatible solvent system, wherein the liquid composition may optionally further include a therapeutic agent dissolved or emulsified in the biocompatible solvent system, wherein the TFE moiety mole content to vinyl moiety content is about 10:90, about 20:80, about 30:70, about 40:60, about 50:50, about 60:40, about 70:30, about 80:20, or about 90:10 or wherein the TFE moiety mole content is about 15.5-23.5% and the vinyl moiety mole content is about 76.5-84.5% ([0051]-[0052]). The instant specification also teaches the concentration of the fluorinated copolymer in the biocompatible solvent system is about 2-20% wt./vol. and said concentration may be modified to produce a hardened material having the desired porosity ([0053]). The instant specification teaches that the biocompatible solvent system may be a low-toxicity, water-miscible solvent such as “Class 3 Solvents” to include acetic acid, acetone, anisole, 1-butanol, 2-butanol, butyl acetate, tert-butylmethyl ether, dimethyl sulfoxide (DMSO), ethanol, ethyl acetate, ethyl ether, ethyl formate, formic acid, heptane, isobutyl acetate, isopropyl acetate, methyl acetate, 3-methyl-1 -butanol, methylethyl ketone, methylisobutyl ketone, 2- methyl-1-propanol, pentane, 1-pentanol, 1-propanol, 2-propanol, propyl acetate, methyl acetate, triethylamine, propylene glycol, polyethylene glycol (PG), polyethylene oxide, and the like or the biocompatible solvent system include acetonitrile, dioxane, formamide, dimethylformamide, pyridine, N-Methyl-2-pyrrolidone (NMP), methylpyrrolidone, dimethylacetamide, ethylene glycol, methyoxymethanol, pyridine, piperidine, sulfolane, tetrahydrofuran, trichloroacetic acid, and the like ([0054]). The instant specification teaches that the liquid composition is capable of being injected or otherwise delivered (e.g., via a syringe or catheter) in vivo to a treatment site of a patient and once the liquid composition is delivered and comes into contact with blood or other bodily fluids, the liquid composition hardens/cures/gels ([0060]-[0061]). The specification defines “hardened material” as “a fluorinated copolymer that is precipitated and/or gelled to a coherent mass or a coherent porous mass in a solid state or gel state ([0061]). Fig. 2 illustrates the liquid composition being delivered to a site and the resulting hardened filamentous structure comprising pores.
In light of the teachings of the instant specification, the porous material is a result of the materials that make up the porous material and the method in which it is made and applied. Cleek teaches the same composition comprising the same materials and amounts thereof and the same method of making and applying thereof. MPEP 2112.01(I) states,
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433.
Since the claimed and prior art products are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. A skilled artisan would have reasonably expected that the same method of making and applying the same composition would yield a product having the same characteristics claimed including filamentous structures that cooperate to define a plurality of macropores having an average diameter greater than 1 micron and accounting for at least 20% void volume. Additionally, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to optimize the mole percentages of TFE and functional monomers as well as amounts of the fluorinated copolymer in the emulsion by way of routine experimentation with a reasonable expectation of success. MPEP 2144.05(I) states, “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. Additionally, MPEP 2144.05(II)(A) states,
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. "[W]here 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."
The claimed ranges overlap or lie inside ranges disclosed by the prior art, thus, a prima facie case of obviousness exists. A skilled artisan would have further been motivated to discover the optimum or workable ranges within the ranges taught by the prior art because it is “the normal desire of scientists or artisans to improve upon what is already generally known” (MPEP 2144.02(II)(A)).
Cleek is silent to each filamentous structure comprises a plurality of micropores (instant claim 1).
However, Cleek, as discussed above, teaches the same composition comprising the same materials and amounts thereof and the same method of making and applying thereof. MPEP 2112.01(I) states,
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433.
Since the claimed and prior art products are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. A skilled artisan would have reasonably expected that the same method of making and applying the same composition would yield a product having the same characteristics claimed including each filamentous structure comprises a plurality of micropores. Additionally, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to optimize the mole percentages of TFE and functional monomers as well as amounts of the fluorinated copolymer in the emulsion by way of routine experimentation with a reasonable expectation of success. MPEP 2144.05(I) states, “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. Additionally, MPEP 2144.05(II)(A) states,
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. "[W]here 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."
The claimed ranges overlap or lie inside ranges disclosed by the prior art, thus, a prima facie case of obviousness exists. A skilled artisan would have further been motivated to discover the optimum or workable ranges within the ranges taught by the prior art because it is “the normal desire of scientists or artisans to improve upon what is already generally known” (MPEP 2144.02(II)(A)).
Regarding instant claims 2 and 3, Cleek teaches the elements described above. Cleek is silent to pores having an average diameter of 14-45 microns or 17-44 microns. However, Cleek, as discussed above, teaches the same composition comprising the same materials and amounts thereof and the same method of making and applying thereof. MPEP 2112.01(I) states,
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433.
Since the claimed and prior art products are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. A skilled artisan would have reasonably expected that the same method of making and applying the same composition would yield a product having the same characteristics claimed including pores having an average diameter of 15-45 microns or 17-44 microns. Additionally, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to optimize the mole percentages of TFE and functional monomers as well as amounts of the fluorinated copolymer in the emulsion by way of routine experimentation with a reasonable expectation of success. MPEP 2144.05(I) states, “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. Additionally, MPEP 2144.05(II)(A) states,
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. "[W]here 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."
The claimed ranges overlap or lie inside ranges disclosed by the prior art, thus, a prima facie case of obviousness exists. A skilled artisan would have further been motivated to discover the optimum or workable ranges within the ranges taught by the prior art because it is “the normal desire of scientists or artisans to improve upon what is already generally known” (MPEP 2144.02(II)(A)).
Regarding instant claims 4 and 5, Cleek teaches the elements described above. Cleek is silent to macropores (pores having an average diameter greater than 1 micron) accounting for 20-80% void volume or 34-80% void volume.
However, Cleek, as discussed above, teaches the same composition comprising the same materials and amounts thereof and the same method of making and applying thereof. MPEP 2112.01(I) states,
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433.
Since the claimed and prior art products are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. A skilled artisan would have reasonably expected that the same method of making and applying the same composition would yield a product having the same characteristics claimed including macropores (pores having an average diameter greater than 1 micron) accounting for 20-80% void volume or 34-80% void volume. Additionally, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to optimize the mole percentages of TFE and functional monomers as well as amounts of the fluorinated copolymer in the emulsion by way of routine experimentation with a reasonable expectation of success. MPEP 2144.05(I) states, “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. Additionally, MPEP 2144.05(II)(A) states,
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. "[W]here 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."
The claimed ranges overlap or lie inside ranges disclosed by the prior art, thus, a prima facie case of obviousness exists. A skilled artisan would have further been motivated to discover the optimum or workable ranges within the ranges taught by the prior art because it is “the normal desire of scientists or artisans to improve upon what is already generally known” (MPEP 2144.02(II)(A)).
Regarding instant claim 6, Cleek teaches the elements described above. Cleek is silent to the average diameter of the macropores (pores having an average diameter greater than 1 micron) is uniform over a thickness of at least 0.5 mm.
However, Cleek, as discussed above, teaches the same composition comprising the same materials and amounts thereof and the same method of making and applying thereof. MPEP 2112.01(I) states,
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433.
Since the claimed and prior art products are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. A skilled artisan would have reasonably expected that the same method of making and applying the same composition would yield a product having the same characteristics claimed including the average diameter of the macropores (pores having an average diameter greater than 1 micron) is uniform over a thickness of at least 0.5 mm. Additionally, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to optimize the mole percentages of TFE and functional monomers as well as amounts of the fluorinated copolymer in the emulsion by way of routine experimentation with a reasonable expectation of success. MPEP 2144.05(I) states, “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. Additionally, MPEP 2144.05(II)(A) states,
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. "[W]here 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."
The claimed ranges overlap or lie inside ranges disclosed by the prior art, thus, a prima facie case of obviousness exists. A skilled artisan would have further been motivated to discover the optimum or workable ranges within the ranges taught by the prior art because it is “the normal desire of scientists or artisans to improve upon what is already generally known” (MPEP 2144.02(II)(A)).
Regarding instant claims 10 and 11, Cleek teaches the elements described above. Cleek is silent to wherein the micropores have an average diameter of 1 micron or less and account for at least 1% void volume (instant claim 10) and wherein the micropores have an average diameter of 0.1-0.6 microns and account for 1-20% void volume (instant claim 11).
However, Cleek, as discussed above, teaches the same composition comprising the same materials and amounts thereof and the same method of making and applying thereof. MPEP 2112.01(I) states,
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433.
Since the claimed and prior art products are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. A skilled artisan would have reasonably expected that the same method of making and applying the same composition would yield a product having the same characteristics claimed including each filamentous structure comprises a plurality of micropores, wherein the micropores have an average diameter of 1 micron or less and account for at least 1% void volume, and wherein the micropores have an average diameter of 0.1-0.6 microns and account for 1-20% void volume. Additionally, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to optimize the mole percentages of TFE and functional monomers as well as amounts of the fluorinated copolymer in the emulsion by way of routine experimentation with a reasonable expectation of success. MPEP 2144.05(I) states, “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. Additionally, MPEP 2144.05(II)(A) states,
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. "[W]here 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."
The claimed ranges overlap or lie inside ranges disclosed by the prior art, thus, a prima facie case of obviousness exists. A skilled artisan would have further been motivated to discover the optimum or workable ranges within the ranges taught by the prior art because it is “the normal desire of scientists or artisans to improve upon what is already generally known” (MPEP 2144.02(II)(A)).
Regarding instant claim 12, Cleek teaches the elements described above. Cleek, in one embodiment, teaches that the therapeutic agent is dissolved within the emulsion before application of the emulsion and subsequent hardening ([0063]). As discussed above, the filamentous structures necessarily result from the hardening of the composition and, as such, a skilled artisan would have reasonably expected that the dissolved therapeutic agent within the emulsion would have resulted in the therapeutic agent being within the hardened filamentous structure.
Regarding instant claim 13, Cleek teaches the elements described above. Cleek teaches applying the emulsion to a substrate (e.g., a medical device, a living organ, or a living tissue) via a single spray nozzle such as a needle, catheter, syringe, dispensing tip, pipet, etc.) ([0062]-[0063]).
Regarding instant claim 14, Cleek teaches the elements described above. Cleek is silent to the macropores being interconnected.
However, Cleek, as discussed above, teaches the same composition comprising the same materials and amounts thereof and the same method of making and applying thereof. MPEP 2112.01(I) states,
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433.
Since the claimed and prior art products are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. A skilled artisan would have reasonably expected that the same method of making and applying the same composition would yield a product having the same characteristics claimed including the macropores are interconnected. Additionally, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to optimize the mole percentages of TFE and functional monomers as well as amounts of the fluorinated copolymer in the emulsion by way of routine experimentation with a reasonable expectation of success. MPEP 2144.05(I) states, “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. Additionally, MPEP 2144.05(II)(A) states,
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. "[W]here 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."
The claimed ranges overlap or lie inside ranges disclosed by the prior art, thus, a prima facie case of obviousness exists. A skilled artisan would have further been motivated to discover the optimum or workable ranges within the ranges taught by the prior art because it is “the normal desire of scientists or artisans to improve upon what is already generally known” (MPEP 2144.02(II)(A)).
Regarding instant claim 15, Cleek teaches the elements described above. Cleek teaches that the formulation consists essentially of the fluorinated copolymer, solvents and a therapeutic agent (abstract).
Regarding instant claim 32, Cleek teaches the elements described above. Cleek teaches particular embodiments having 6%, 8%, and 10% of copolymer in the formulations which fall within the claimed 2-20% range. Additionally, while Cleek is silent to a gelation storage modulus of 50-500,000 Pa, the instant specification exemplifies a particular embodiment comprising 10% TFE-VOH as the fluorinated copolymer, DMSO and water in a ratio of 60:40 as the biocompatible solvent system, and a rheology gelation storage modulus of 2.5 kPa (2500 Pa) (Sample P22 in Table 3). The exemplified embodiment of P22 is identical to a formulation of Cleek in Table 6 (i.e., 10% TFE-VOH as the fluorinated copolymer, DMSO and water in a ratio of 60:40 as the biocompatible solvent system) (see also Examples 14 and 15 for further details).
MPEP 2112.01(I) states,
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433.
MPEP 2112.01(II) also states, “[p]roducts of identical chemical composition can not have mutually exclusive properties” and “[a] chemical composition and its properties are inseparable”. Since the claimed and prior art products are identical or substantially identical, a prima facie case has been established. A skilled artisan would have reasonably expected that the same formulation would yield a product having the same properties including a gelation storage modulus of 50 Pa to 500,000 Pa.
Regarding instant claim 33, said claim is essentially the limitations of claims 1 and 11 (excluding intervening claim 4). Cleek meets the limitations of claims 1 and 11 as described above.
Thus, the teachings of Cleek render the instant claims prima facie obvious.
Response to Arguments
Applicant's arguments, filed March 3, 2026, regarding the 103 rejection over Cleek have been fully considered but they are not persuasive.
Applicant alleges that the Office has failed to meets its burden that each feature in question is necessarily present in the cited reference. Applicant asserts that Cleek does not inherently or necessarily produce a porous material comprising filamentous structures as claimed. Applicant notes that Cleek is directed to kinetically stable emulsions and emphasizes the formation of “uniform coating” and homogenous mixtures” by emulsion and solvent evaporation or leaching. Applicant notes that the instant specification and supporting examples demonstrate that specific process conditions, including copolymer concentration, solvent/water ratios, temperature, and precipitation parameters, are required to obtain the claimed filamentous structure and porosity. Applicant also asserts that any porosity described in Cleek results from the addition of leachable pore-forming agents or gas-producing agents whereas the claimed micropores are formed intrinsically within the filamentous copolymer structures as a result of phase separation during precipitation/hardening, without the use of any leachable pore-forming agent or separate additive. Remarks, pages 9-12.
In response, it is respectfully submitted that Cleek defines kinetically stable as a degree of stability wherein a component of an emulsion remains suspended (i.e., precipitation, flocculation, sedimentation, separation, or coalescence of a component is not visibly detectable with the naked eye) for at least one minute, at least 5 minutes, at least 30 minutes, at least 60 minutes, at least one month, a least 4 months, or at least one year ([0051]. Such a definition allows for an embodiment where precipitation, flocculation, sedimentation, separation, or coalescence of a component after one minute. Thus, Cleek’s definition of kinetically stable is broad and one would envisage embodiments that would not be kinetically stable for more than one minute. It is further submitted that the instant specification teaches liquid compositions (including emulsions) are poured onto a substrate and hardened into a film (e.g., [00051] and [00082]) and similarly, Cleek teaches an emulsion that is applied to a substrate and hardens into a coating (film) ([0062]). It is further submitted that the claims recite open-ended “comprising” language and, as such, do not exclude pore-forming agents or gas-producing agents. Thus, while Cleek does not explicitly teach “filamentous structures, wherein the filamentous structures cooperate to define a plurality of macropores having an average diameter greater than 1 micron and accounting for at least 20% void volume”, Cleek teaches the same composition comprising the same materials and amounts thereof and the same method of making and applying thereof. MPEP 2112.01(I) states,
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433.
Since the claimed and prior art products are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. A skilled artisan would have reasonably expected that the same method of making and applying the same composition would yield a product having the same characteristics claimed including filamentous structures that cooperate to define a plurality of macropores having an average diameter greater than 1 micron and accounting for at least 20% void volume. Thus, contrary to applicant’s assertion that the Office has failed to meets its burden that each feature in question is necessarily present in the cited reference, the Office has shown a sound basis for believing the product of the applicant and prior art are the same. A prima facie case has been established. Per MPEP 2112.01(I), applicant can rebut the prima facie case by providing evidence showing that the prior art products do not possess the characteristics of the claimed product.
With respect to Applicant’s statement that the instant specification and supporting examples demonstrate that specific process conditions, including copolymer concentration, solvent/water ratios, temperature, and precipitation parameters, are required to obtain the claimed filamentous structure and porosity, it is suggested that the asserted required elements to yield the claimed features are included in the claims. Such elements may help to differentiate from the teachings of Cleek.
For these reasons, applicant’s arguments are not persuasive.
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 1-6, 10-15, 32 and 33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 10,092,653.
Although the claims at issue are not identical, they are not patentably distinct from each other because the subject matter of the patented claims and the subject matter of the instant claims are significantly overlapping.
The instant claims are drawn to a porous material comprising: a plurality of filamentous structures comprising a fluorinated copolymer with a tetrafluoroethylene moiety and a vinyl moiety having at least one functional group selected from acetate, alcohol, amine, and amide, the filamentous structures cooperating to define a plurality of macropores having an average diameter greater than 1 µm and accounting for at least 20% void volume, wherein the fluorinated copolymer is one of poly(tetrafluoroethylene-co-vinyl acetate) (TFE-VAc) and poly(tetrafluoroethylene-co-vinyl alcohol) (TFE-VOH), and wherein the fluorinated copolymer has a tetrafluoroethylene moiety mole content of 15.5% to 23.5% and a vinyl moiety mole content of 76.5% to 84.5%.
The patented claims are drawn to a coating consisting of: a tetrafluoroethylene copolymer; and dexamethasone sodium phosphate, wherein the coating is formed by applying a kinetically stable emulsion consisting of a tetrafluoroethylene copolymer dissolved in a water miscible organic solvent and dexamethasone sodium phosphate dissolved in water, and removing the water miscible organic solvent and water, and wherein the coating has a weight percentage of dexamethasone sodium phosphate of 69% by mass, and at least a 50% reduction in excess heat capacity on a tetrafluoroethylene copolymer mass basis as compared with a coating of tetrafluoroethylene copolymer with no dexamethasone sodium phosphate, and wherein the polytetrafluoroethylene copolymer is poly(tetrafluoroethylene-co-vinyl acetate) (TFE-VAc).
The patented claims do not recite, “wherein the fluorinated copolymer has a tetrafluoroethylene moiety mole content of 15.5% to 23.5% and a vinyl moiety mole content of 76.5% to 84.5%”. However, Table 2 of the patent describes that the fluorinated copolymer (TFE-VAc) has a tetrafluoroethylene moiety mole content of 15.5% to 23.5% and a vinyl moiety mole content of 76.5% to 84.5%.
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a tetrafluoroethylene moiety mole content of 15.5% to 23.5% and a vinyl moiety mole content of 76.5% to 84.5% into the instant invention as suggested by the patent with a reasonable expectation of success. A skilled artisan would have been motivated to do so because the patent teaches that said amounts are capable of forming a stable emulsion (col. 10, lines 25-43).
The patented claims do not recite, “a porous material comprising a plurality of filamentous structures… the filamentous structures cooperating to define a plurality of macropores having an average diameter greater than 1 µm and accounting for at least 20% void volume... wherein each filamentous structure comprises a plurality of micropores”.
The instant specification teaches a liquid composition comprising a fluorinated copolymer (e.g., TFE-VAc or TFE-VOH) dissolved or emulsified in a biocompatible solvent system, wherein the liquid composition may optionally further include a therapeutic agent dissolved or emulsified in the biocompatible solvent system ([0051]-[0052]). The instant specification teaches applying the liquid composition to a substrate that hardens into a dry film (i.e. coating) and the pore morphology/porosity were calculated ([0082]-[0083]; Table 3).
While the patent does not recite the specific characteristics mentioned above, said characteristics appear to be dependent on the composition and coating thereof. MPEP 2112.01(I) states,
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433.
Since the claimed and patented products are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. A skilled artisan would have reasonably expected that the same method of making and applying the same composition would yield a product having the same characteristics claimed including filamentous structures cooperating to define a plurality of macropores having an average diameter of greater than 1 micron and accounting for at least 20% void volume and wherein each filamentous structure comprises a plurality of micropores.
Thus, the instant claims are unpatentable over the patented claims.
Claims 1-6, 10-15, 32 and 33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 11,642,412.
Although the claims at issue are not identical, they are not patentably distinct from each other because the subject matter of the patented claims and the subject matter of the instant claims are significantly overlapping.
The instant claims are described above.
The patented claims are drawn to a method for coating a substrate, the method comprising the steps of: a) providing a water in solvent emulsion comprising a tetrafluoroethylene copolymer having a tetrafluoroethylene mole content of at least about 15% and a functional monomer mole content of at least about 77%, wherein the functional monomer comprises a functional group selected from a group consisting of acetate, alcohol, amine, amide, and combinations thereof, a solvent phase comprising a water miscible organic solvent, an agent comprising one of a water soluble agent and a hydrophobic agent, and a water phase, wherein the emulsion is kinetically stable; b) applying the water-in-solvent emulsion to the substrate; and c) removing the solvent and water thereby forming a coating on the substrate, wherein the substrate comprises a living surface comprising an intima of a vessel, an adventitia of a vessel, an organ, and a biological tissue. The patent further recites the particular tetrafluoroethylene polymers TFE-VAc and TFE VOH (claims 3 and 4).
While the patent does not explicitly recite a tetrafluoroethylene moiety mole content of 15.5% to 23.5% and a vinyl moiety mole content of 76.5% to 84.5%, the patent does recite “a tetrafluoroethylene mole content of at least about 15% and a functional monomer mole content of at least about 77%, wherein the functional monomer comprises a functional group (e.g., alcohol or acetate).
MPEP 2144.05(I) states, “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. Additionally, MPEP 2144.05(II)(A) states,
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. "[W]here 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."
The claimed ranges overlap or lie inside ranges recited by the patent, thus, a prima facie case of obviousness exists. A skilled artisan would have further been motivated to discover the optimum or workable ranges within the ranges recited by the patent because it is “the normal desire of scientists or artisans to improve upon what is already generally known” (MPEP 2144.02(II)(A)).
The patented claims do not recite, “a porous material comprising a plurality of filamentous structures… the filamentous structures cooperating to define a plurality of macropores having an average diameter greater than 1 µm and accounting for at least 20% void volume... wherein each filamentous structure comprises a plurality of micropores”.
The instant specification teaches a liquid composition comprising a fluorinated copolymer (e.g., TFE-VAc or TFE-VOH) dissolved or emulsified in a biocompatible solvent system, wherein the liquid composition may optionally further include a therapeutic agent dissolved or emulsified in the biocompatible solvent system ([0051]-[0052]). The instant specification teaches applying the liquid composition to a substrate that hardens into a dry film (i.e. coating) and the pore morphology/porosity were calculated ([0082]-[0083]; Table 3).
While the patent does not recite the specific characteristics mentioned above, said characteristics appear to be dependent on the composition and coating thereof. MPEP 2112.01(I) states,
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433.
Since the claimed product is produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. A skilled artisan would have reasonably expected that the same method of making and applying the same composition would yield a product having the same characteristics claimed including filamentous structures cooperating to define a plurality of macropores having an average diameter of greater than 1 micron and accounting for at least 20% void volume and wherein each filamentous structure comprises a plurality of micropores.
Thus, the instant claims are unpatentable over the patented claims.
Response to Arguments
Applicant's arguments, filed March 3, 2026, regarding the double patenting rejections over 10,092,653 and 11,642,412 have been fully considered but they are not persuasive.
Applicant requests reconsideration of the double patenting rejections and reserves the right to file a terminal disclaimer should the double patenting rejection be maintained after such times as the claims have been deemed allowable. Remarks, page 13.
In response, applicant’s request is acknowledged. The double patenting rejections have been reconsidered and remain applicable to the pending claims.
Conclusion
All claims have been rejected; no claims are allowed.
Correspondence
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/CASEY S HAGOPIAN/Examiner, Art Unit 1617
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