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 .
Status of the Claims
Claims 1-21 are pending and currently under examination.
Information Disclosure Statement
The IDS dated 8/21/2023, 11/29/2023, 2/5/2024, 7/19/2024, 3/10/2025 and 8/7/2025 have been considered. Signed copies are enclosed herewith.
Specification
The disclosure is objected to because of the following informalities:
the word “polyfacryloyloethyltrimethylammonium” is recited at least 5 times in the instant specification (e.g., [00012], [00025], [00033], [00044] and [000121]). Said word appears to be misspelled;
“DMA gel” is recited multiple times in the instant specification (e.g., [00012]). When an acronym appears in the specification or claims, it is appropriate to recite the full name, followed by the acronym in parenthesis, such as “dimethacrylate (DMA)” and then recite only the acronym in subsequent reiterations; and
There are many instances of capitalizations where lower case should be used (e.g., Graphene oxide/Xonolite, Tricalcium phosphate, Agar-polyhydroxyethylmethacrylate gel, Guanine-boric acid, etc.). Please thoroughly review the instant specification and make corrections as appropriate.
Correction is requested.
Claim Objections
Claim 7 is objected to because of the following informalities: the claim recites “Aramid” in line 3 of the claim. Said limitation should be in lowercase.
Claim 10 is objected to because of the following informalities:
The claim recites “Guanine”, “Graphene”, “Xonotlite” and “Agar” in the claim. Said limitations should be in lowercase.
The claim recites “one or more of...” in the 2nd line of the claim and “or hydrogels composed of a combination of these polymers” in the last line of the claim. The limitations are redundant. It is suggested that one or the limitations is deleted from the claim.
The claim recites the word “polyfacryloyloethyltrimethylammonium” in line 12 of the claim. Said word appears to be misspelled.
The claim recites the word “poly(3- (methylacryloylamino)propyl-trimethylammonium chloride hydrogel” in line 13 of the claim. There is an extra space between “poly(3-” “(methylacryloylamino)” that should be deleted.
The claim recites, “DMA gel” at line 11 of the claim. When an acronym appears in the claims, it is appropriate to recite the full name, followed by the acronym in parenthesis, such as “dimethacrylate (DMA)” and then recite only the acronym in subsequent reiterations.
Claim 15 is objected to because of the following informalities: the claim recites “α-TCP”. When an acronym appears in the claims, it is appropriate to recite the full name, followed by the acronym in parenthesis, such as “α-tricalcium phosphate (α-TCP)” and then recite only the acronym in subsequent reiterations.
Appropriate correction is requested.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 10 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 10, the phrase “e.g.,” at line 6 renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 2, 6-11 and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wiley et al. (WO 2019/094426 A1, May 16, 2019, hereafter as “Wiley”).
The instant claims are drawn to method of attaching a hydrogel to a surface so that the hydrogel is secured to the surface with a shear strength of greater than 1 MPa, the method comprising: bonding a dry nanofiber network to the surface; and infiltrating the bonded nanofiber network with the hydrogel, to form a multi-network hydrogel, wherein the multi-network hydrogel is secured to the surface with a shear strength of greater than 1 MPa. Regarding instant claims 1, 2, 6 and 9, Wiley teaches artificial cartilage materials for repair and replacement of cartilage, wherein the artificial cartilage materials include triple-network hydrogels comprising a cross-linked fiber network (e.g., bacterial cellulose nanofiber network) and a double-network hydrogel (e.g. a double network hydrogel comprising polyacrylamide-methyl propyl sulfonic acid “PAMPS”); and methods of making thereof (abstract; [0012] and [0049]). Wiley teaches infiltrating the cross-linked fiber network with a double-network hydrogel to form the triple-network hydrogel ([0078]). Wiley also teaches dehydration of the triple network hydrogels (i.e., dry; [0081]). Said artificial cartilage comprising the cross-linked fiber network and the double-network hydrogel can be coated onto an implant (abstract). Wiley further teaches polyvinyl alcohol (PVA) as a particular double-network hydrogel material ([0048]). Wiley also teaches including an adhesive for fixation of the triple-network hydrogel to an implant (bonding; [0016] and [0066]). It is noted that the instant specification uses adhesive and cement interchangeably ([0006] of specification) and thus, the “adhesive” of Wiley reads on the claimed “cement”. Wiley also teaches an implant having a porous surface such as 0.1-300 micrometer-sized micropores (abstract; [0037]; Fig. 11A).
Wiley is silent to “wherein the multiple-network hydrogel is secured to the first surface with a shear strength that is greater than 1 MPa”.
However, shear strength is a property of the of materials utilized. MPEP 2112.01 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” and “[a] chemical composition and its properties are inseparable”. Wiley teaches/suggests the same structural components of the multiple-network hydrogel, cement/adhesive, and implant surface, and as such a skilled artisan would reasonably expect the same components to yield the same properties as that of the claimed implant. Please note that the Patent and Trademark Office is not equipped to conduct experimentation in order to determine whether Applicant’s implant differs and, if so, to what extent, from that of the discussed references. Therefore, with the showing of the reference, the burden of establishing that the prior art products do not necessarily possess the characteristics of the claimed product by objective evidence is shifted to Applicants.
Regarding instant claim 7, Wiley teaches the elements discussed above. Wiley also teaches the fiber network can comprise electrospun poly(vinyl alcohol) (PVA) fibers, aramid nanofibers (e.g., aramid-PVA nanofibers), wet-spun silk protein fiber, chemically crosslinked cellulose nanofiber, polycaprolactone fibers (e.g., 3D woven PCL fibers), electrospun gelatin nanofibers ([0044]).
Regarding instant claim 8, Wiley teaches the elements discussed above. Wiley also teaches rehydration of the triple-network hydrogel (comprising the nanofiber network) ([0081]-[0082]).
Regarding instant claim 10, Wiley teaches the elements discussed above. Wiley also teaches a double-network hydrogel comprising PAMPS and poly-(N,N'-dimethyl acrylamide) (PDMAAm) ([0046]). Wiley further teaches hydrogels comprising copolymers of 1-vinylimidazole and methacrylic acid, amphiphilic triblock copolymers, polyampholyte hydrogels, a PVA-tannic acid hydrogel, a poly(N-acryloyl) glycinamide hydrogel, polyacrylic acid-acrylamide-C18 hydrogel, guanine-boric acid reinforced PDMAA, polyelectrolyte hydrogels, a poly(acrylonitrile-co-l-vinylimidazole) hydrogel (e.g., a mineralized poly(acrylonitrile-co-l-vinylimidazole) hydrogel), a PAMPS/MMT clay composite hydrogel, a polyacrylic acid-Fe3+-chitosan hydrogel, a PMAAc gel, a graphene oxide/gonotlite reinforced PAAm gel, a poly(stearyl methacrylate) -polyacrylic acid gel, an annealed PVA-PAA hydrogel, supramolecular hydrogels from multiurea linkage segmented copolymers, PAN-PAAm hydrogel, a microsilica reinforced DMA gel, an agar-PHEMA gel, PEG (polyethylene glycol); (polyacryloyloethyltrimethylammonium chloride); PMPTC (poly(3- (methylacryloylamino)propyl-trimethylammonium chloride); PNaSS (poly(sodium p- styrenbesulfonate)); and (polyethylene glycol diacrylate) ([0047]-[0048]).
Regarding instant claim 11, Wiley teaches the elements discussed above. Said claim recites the limitation, “wherein cementing comprises extending a cement at least 5 microns into the nanofiber network from the surface”. Wiley is silent to this particular feature. However, as explained above, Wiley teaches the identical or substantially identical cross-linked cellulose nanofiber network as well as an adhesive (i.e., cement). MPEP 2112.01 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”. Wiley teaches the same structural components and method of making and, as such, a skilled artisan would reasonably expect the same components to yield the same feature of “wherein cementing comprises extending a cement at least 5 microns into the nanofiber network from the surface” as that of the claimed method. Please note that the Patent and Trademark Office is not equipped to conduct experimentation in order to determine whether Applicant’s implant differs and, if so, to what extent, from that of the discussed references. Therefore, with the showing of the reference, the burden of establishing that the prior art products do not necessarily possess the characteristics of the claimed product by objective evidence is shifted to Applicants.
Regarding instant claim 13, Wiley teaches the elements discussed above. Said claim recites the limitation, “further comprising mineralizing at least a portion of the nanofiber network adjacent to the surface”. The instant specification explains that said mineralization can occur with hydroxyapatite ([0024]). Wiley teaches that the triple-network hydrogel comprising the nanofiber network can be treated to form hydroxyapatite within the surface of the triple-network hydrogel ([0072] and [0076]). Said treatment greatly improves osseointegration at 4 weeks ([0076]). Thus, Wiley’s teaching of treating the triple-network hydrogel comprising the nanofiber network to form hydroxyapatite within the surface of the triple-network hydrogel reads on the claimed limitation, “mineralizing at least a portion of the nanofiber network adjacent to the surface”.
Thus, the teachings of Wiley render the instant claims anticipated.
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.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Wiley et al. (WO 2019/094426 A1, May 16, 2019, hereafter as “Wiley”), as applied to claim 1 above.
The claimed invention is described above.
Wiley teaches the elements discussed above.
Wiley additionally teaches molding the hydrogel ([0084]-[0085]).Wiley also teaches an outer surface of the hydrogel may have a pores of between 0.1-300 micrometers in diameter ([0014]).
While Wiley does not explicitly teach “an outer surface of the hydrogel has a roughness of less than 30 microns”, Wiley teaches that the outer surface of the hydrogel may have a pores of between 0.1-300 micrometers in diameter. 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”. Because the claimed range of less than 30 microns overlaps with the range of between 0.1-300 micrometers in diameter disclosed by the prior art, a prima facie case of obviousness exists.
Thus, the teachings of Wiley render the instant claim prima facie obvious.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Wiley et al. (WO 2019/094426 A1, May 16, 2019, hereafter as “Wiley”), as applied to claim 1 above, in view of Reddy et al. (WO 2019/217765 A1, Nov. 14, 2019, hereafter as “Reddy”).
The claimed invention is described above.
Wiley teaches the elements discussed above including dehydration of the triple-network hydrogel comprising the nanofiber network.
Wiley is silent to a freeze-dried nanofiber network.
Reddy teaches an implantable nanofiber hydrogel composite material for tissue repair (abstract). Reddy also teaches lyophilization of the fiber-hydrogel composite to allow for storage of the product at room temperature for extended periods of time without loss of function, i.e., extend the product’s shelf life (page 8, 3rd paragraph; page 29, last paragraph – page 30, 2nd paragraph).
Wiley and Reddy are both drawn to implantable nanofiber-hydrogel composites, thus, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to include a freeze-dried nanofiber network into the invention of Wiley as suggested by Reddy with a reasonable expectation of success. A skilled artisan would have been motivated to do so because Reddy teaches that lyophilization of a fiber-hydrogel composite allows for storage of the product at room temperature for extended periods of time without loss of function, i.e., effectively extending the product’s shelf life.
Thus, the combined teachings of Wiley and Reddy render the instant claims prima facie obvious.
Claims 15 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Wiley et al. (WO 2019/094426 A1, May 16, 2019, hereafter as “Wiley”), as applied to claims 1-2 above, in view of Procter et al. (US 2020/0038545 A1, Feb. 6, 2020, hereafter as “Procter”).
The claimed invention is described above.
Wiley teaches the elements discussed above.
Wiley is silent to the particular cement/adhesive materials, α-TCP (instant claim 15) and calcium silicate (instant claim 16).
Procter teaches an adhesive material used in implant or tissue repair applications, the adhesive material comprising α-TCP and/or calcium silicate (abstract; [0001]-[0003] and [0034]).
Wiley and Procter are both drawn to adhesive materials used in implant or tissue repair applications, thus, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to include the particular adhesive materials α-TCP and/or calcium silicate into the invention of Wiley as suggested by Procter with a reasonable expectation of success. A skilled artisan would have been motivated to do so because Procter teaches that α-TCP and/or calcium silicate are suitable adhesive materials for the same purpose of implant or tissue repair applications.
Thus, the combined teachings of Wiley and Procter render the instant claims prima facie obvious.
Claims 14, 17, 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Wiley et al. (WO 2019/094426 A1, May 16, 2019, hereafter as “Wiley”), as applied to claims 1 and 2 above, in view of Huerta et al. (USPN 8,431,226 B2, Apr. 30, 2013, hereafter as “Huerta”).
The claimed invention is described above.
Regarding instant claim 14, Wiley teaches the elements discussed above.
Wiley is silent to wherein the surface is greater than 40% porous to a depth of 1 mm or greater.
Huerta teaches biologic coatings on a surface of a prothesis or implantable device comprising biologically compatible hydrogels that bind to the adhesive on a surface of said prosthesis or implantable device (col. 1, lines 49-51). Huerta teaches that the prothesis or medical device can be of any composition, such as metal, ceramic, resin, biologic, polymer, graphite, plastic, diamond, glass and the like, as well as composites and mixtures thereof (col. 2, lines 17-20). Huerta also teaches that the surface of the prosthesis is porous for enhanced surface area which allows for enhanced tissue ingrowth and incorporates by reference, USPN 4,550,448 (hereinafter as “Kenna”) as an example of a porous surface (col. 3, lines 41-56; col. 21, lines 49-50). Kenna teaches a particular porous surface having a porosity of from about 35-40% and a thickness of about 1.3-1.5 mm (col. 3, lines 38-41; claims 3-4). It is noted that the term “about” allows for values slightly higher and lower than the recited value. Additionally, the instant specification states that “all numbers may be read as if prefaced by the word "about" or “approximately,” even if the term does not expressly appear” and “a numeric value may have a value that is +/- 0.1% of the stated value (or range of values), +/- 1% of the stated value (or range of values), +/- 2% of the stated value (or range of values), +/- 5% of the stated value (or range of values), +/- 10% of the stated value (or range of values), etc.” ([0195]). Thus, in the light of the specification, the limitation, “greater than 40% porous to a depth of 1 mm or greater” is being interpreted as greater than about 40% porous to a depth of about 1 mm or greater which includes porosities of less than 40% and depths of less than 1 mm.
Wiley and Huerta are both drawn to implants comprising a hydrogel coating, wherein said hydrogel coating is attached via an adhesive, thus, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to include an implant having a porous surface that is greater than 40% porous to a depth of 1 mm or greater in Wiley as suggested by Huerta/Kenna with a reasonable expectation of success. A skilled artisan would have been motivated to do so because Huerta teaches that implants having a porous surface such as the one advanced by Kenna allows for increased surface area thereby allowing for enhanced tissue ingrowth.
Regarding instant claims 17, 19 and 20, Wiley teaches artificial cartilage materials for repair and replacement of cartilage, wherein the artificial cartilage materials include triple-network hydrogels comprising a cross-linked fiber network (e.g., bacterial cellulose nanofiber network) and a double-network hydrogel (e.g. a double network hydrogel comprising polyacrylamide-methyl propyl sulfonic acid “PAMPS”); and methods of making thereof (abstract; [0012] and [0049]). Wiley teaches infiltrating the cross-linked fiber network with a double-network hydrogel to form the triple-network hydrogel ([0078]). Wiley also teaches dehydration (i.e., drying) of the triple network hydrogels and subsequent rehydration ([0081]-[0082]). Said artificial cartilage comprising the cross-linked fiber network and the double-network hydrogel can be coated onto an implant (abstract). Wiley further teaches polyvinyl alcohol (PVA) as a particular double-network hydrogel material ([0048]). Wiley also teaches including an adhesive for fixation of the triple-network hydrogel to an implant (bonding; [0016] and [0066]). It is noted that the instant specification uses adhesive and cement interchangeably ([0006] of specification) and thus, the “adhesive” of Wiley reads on the claimed “cement”. Wiley also teaches an implant having a porous surface such as 0.1-300 micrometer-sized micropores (abstract; [0037]; Fig. 11A). Wiley additionally teaches molding the hydrogel ([0084]-[0085]).
While Wiley does not explicitly teach “an outer surface of the hydrogel has a roughness of less than 30 microns”, Wiley teaches that the outer surface of the hydrogel may have a pores of between 0.1-300 micrometers in diameter. 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”. Because the claimed range of less than 30 microns overlaps with the range of between 0.1-300 micrometers in diameter disclosed by the prior art, a prima facie case of obviousness exists.
Wiley is silent to “wherein the multiple-network hydrogel is secured to the first surface with a shear strength that is greater than 1 MPa”.
However, shear strength is a property of the of materials utilized. MPEP 2112.01 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” and “[a] chemical composition and its properties are inseparable”. Wiley teaches/suggests the same structural components of the multiple-network hydrogel, cement/adhesive, and implant surface, and as such a skilled artisan would reasonably expect the same components to yield the same properties as that of the claimed implant. Please note that the Patent and Trademark Office is not equipped to conduct experimentation in order to determine whether Applicant’s implant differs and, if so, to what extent, from that of the discussed references. Therefore, with the showing of the reference, the burden of establishing that the prior art products do not necessarily possess the characteristics of the claimed product by objective evidence is shifted to Applicants.
Wiley is silent to the surface of the implant that the hydrogel is attached thereto as porous.
Huerta teaches biologic coatings on a surface of a prothesis or implantable device comprising biologically compatible hydrogels that bind to the adhesive on a surface of said prosthesis or implantable device (col. 1, lines 49-51). Huerta teaches that the prothesis or medical device can be of any composition, such as metal, ceramic, resin, biologic, polymer, graphite, plastic, diamond, glass and the like, as well as composites and mixtures thereof (col. 2, lines 17-20). Huerta also teaches that the surface of the prosthesis is porous for enhanced surface area which allows for enhanced tissue ingrowth (col. 3, lines 41-56).
Wiley and Huerta are both drawn to implants comprising a hydrogel coating, wherein said hydrogel coating is attached via an adhesive, thus, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to include an implant having a porous surface with a reasonable expectation of success. A skilled artisan would have been motivated to do so because Huerta teaches that implants having a porous surface allows for increased surface area thereby allowing for enhanced tissue ingrowth.
The combined teachings of Wiley and Huerta render the instant claims prima facie obvious.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Wiley et al. (WO 2019/094426 A1, May 16, 2019, hereafter as “Wiley”) in view of in view of Huerta et al. (USPN 8,431,226 B2, Apr. 30, 2013, hereafter as “Huerta”) and Reddy et al. (WO 2019/217765 A1, Nov. 14, 2019, hereafter as “Reddy”).
The claimed invention is described above.
Wiley teaches artificial cartilage materials for repair and replacement of cartilage, wherein the artificial cartilage materials include triple-network hydrogels comprising a cross-linked fiber network (e.g., bacterial cellulose nanofiber network) and a double-network hydrogel (e.g. a double network hydrogel comprising polyacrylamide-methyl propyl sulfonic acid “PAMPS”); and methods of making thereof (abstract; [0012] and [0049]). Wiley teaches infiltrating the cross-linked fiber network with a double-network hydrogel to form the triple-network hydrogel ([0078]). Wiley also teaches dehydration (i.e., drying) of the triple network hydrogels and subsequent rehydration ([0081]-[0082]). Said artificial cartilage comprising the cross-linked fiber network and the double-network hydrogel can be coated onto an implant (abstract). Wiley further teaches polyvinyl alcohol (PVA) as a particular double-network hydrogel material ([0048]). Wiley also teaches including an adhesive for fixation of the triple-network hydrogel to an implant (bonding; [0016] and [0066]). It is noted that the instant specification uses adhesive and cement interchangeably ([0006] of specification) and thus, the “adhesive” of Wiley reads on the claimed “cement”. Wiley also teaches an implant having a porous surface such as 0.1-300 micrometer-sized micropores (abstract; [0037]; Fig. 11A). Wiley additionally teaches molding the hydrogel ([0084]-[0085]).
While Wiley does not explicitly teach “an outer surface of the hydrogel has a roughness of less than 30 microns”, Wiley teaches that the outer surface of the hydrogel may have a pores of between 0.1-300 micrometers in diameter. 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”. Because the claimed range of less than 30 microns overlaps with the range of between 0.1-300 micrometers in diameter disclosed by the prior art, a prima facie case of obviousness exists.
Wiley is silent to “wherein the multiple-network hydrogel is secured to the first surface with a shear strength that is greater than 1 MPa”.
However, shear strength is a property of the of materials utilized. MPEP 2112.01 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” and “[a] chemical composition and its properties are inseparable”. Wiley teaches/suggests the same structural components of the multiple-network hydrogel, cement/adhesive, and implant surface, and as such a skilled artisan would reasonably expect the same components to yield the same properties as that of the claimed implant. Please note that the Patent and Trademark Office is not equipped to conduct experimentation in order to determine whether Applicant’s implant differs and, if so, to what extent, from that of the discussed references. Therefore, with the showing of the reference, the burden of establishing that the prior art products do not necessarily possess the characteristics of the claimed product by objective evidence is shifted to Applicants.
Wiley is silent to the surface of the implant that the hydrogel is attached thereto as porous.
Huerta teaches biologic coatings on a surface of a prothesis or implantable device comprising biologically compatible hydrogels that bind to the adhesive on a surface of said prosthesis or implantable device (col. 1, lines 49-51). Huerta teaches that the prothesis or medical device can be of any composition, such as metal, ceramic, resin, biologic, polymer, graphite, plastic, diamond, glass and the like, as well as composites and mixtures thereof (col. 2, lines 17-20). Huerta also teaches that the surface of the prosthesis is porous for enhanced surface area which allows for enhanced tissue ingrowth (col. 3, lines 41-56).
Wiley and Huerta are both drawn to implants comprising a hydrogel coating, wherein said hydrogel coating is attached via an adhesive, thus, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to include an implant having a porous surface with a reasonable expectation of success. A skilled artisan would have been motivated to do so because Huerta teaches that implants having a porous surface allows for increased surface area thereby allowing for enhanced tissue ingrowth.
Wiley is silent to a freeze-dried nanofiber network.
Reddy teaches an implantable nanofiber hydrogel composite material for tissue repair (abstract). Reddy also teaches lyophilization of the fiber-hydrogel composite to allow for storage of the product at room temperature for extended periods of time without loss of function, i.e., extend the product’s shelf life (page 8, 3rd paragraph; page 29, last paragraph – page 30, 2nd paragraph).
Wiley and Reddy are both drawn to implantable nanofiber-hydrogel composites, thus, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to include a freeze-dried nanofiber network into the invention of Wiley as suggested by Reddy with a reasonable expectation of success. A skilled artisan would have been motivated to do so because Reddy teaches that lyophilization of a fiber-hydrogel composite allows for storage of the product at room temperature for extended periods of time without loss of function, i.e., effectively extending the product’s shelf life.
Thus, the combined teachings of Wiley, Huerta and Reddy render the instant claim prima facie obvious.
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 1-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 11,707,555.
Although the claims at issue are not identical, they are not patentably distinct from each other because the subject matter of the instant claims and the subject matter of the patented claims are significantly overlapping.
The instant claims are described above.
The patented claims are drawn to an implant having a hydrogel bonded to a first surface of the implant, the implant comprising: an implant body including the first surface, wherein the first surface is porous; a cross-linked cellulose nanofiber network, wherein the cross-linked cellulose nanofiber network is bonded to the first surface by a cement; and a hydrogel impregnated in the cross-linked cellulose nanofiber network, the hydrogel extending from the first surface, wherein the hydrogel impregnated into the cross-linked cellulose nanofiber network is secured to the first surface with a shear strength that is greater than 1 MPa, wherein the cement is not bonded to the hydrogel.
While the patented claims are drawn to a product, the method of the instant claims would necessarily yield the patented product. Accordingly, the instant claims and the patented claims are not patentably distinct from one another.
Conclusion
All claims have been rejected; no claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CASEY HAGOPIAN whose telephone number is (571)272-6097. The examiner can normally be reached on M-F 9:00 am - 3:30 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue Liu can be reached on 571-272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see https://ppair-my.uspto.gov/pair/PrivatePair. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CASEY S HAGOPIAN/Examiner, Art Unit 1617