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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 7/23/2026 has been entered.
Priority
This application claims priority from provisional application 62858740, filed 6/7/2019.
Status of Action/Claims
Receipt of Remarks/Amendments filed on 7/23/2026 is acknowledged. Claims 1-3, 7, 9-10, 12-13, 24 and 30-41 are currently pending and under examination.
Rejection(s) not reiterated from the previous Office Action are hereby withdrawn. The following rejections are either reiterated or newly applied. They constitute the complete set of rejections presently being applied to the instant application.
New/Maintained Claim Rejection(s)/Objection(s)
Claim Objections
Claims 32, 36, 39 are objected to because of the following informalities:
In claims 32, 36, 39, the recitation “propylene” appears to be a typographical error and should recite “polypropylene”, similar to the polypropylene recited in claim 12 and in the instant specification. There is also no mention of “propylene” as polymeric material in the instant specification, thus, the examiner interprets the recitation “propylene” as a typographical error and should recite “polypropylene”.
Appropriate correction is required.
New Matter
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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claims 10, 36, 41 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) 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, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 10, 36 and 41 require the polymeric material is a biodegradable synthetic polymer or the polymeric material is a biodegradable propylene. Applicants point to paragraph 0005 of instant specification for support. The specifications disclose that in some embodiments, the polymeric material is a synthetic polymer. In some embodiments, the polymeric material is biodegradeable. In some embodiments, the polymeric material is polypropylene. This disclosure in the specification suggests that the polymer can be biodegradable or synthetic (polypropylene falling under synthetic polymer). The specification do not disclose that the polymer can be both biodegradable and synthetic and wherein the polypropylene polymer is also biodegradable, especially in view of the fact that polypropylene by itself is known to be non-biodegradable. Thus, the newly added recitations in claims 10, 36 and 41 requiring the polymeric material is a biodegradable synthetic polymer or the polymeric material is a biodegradable propylene represent new matter. For the purpose of examination, the examiner interprets a biodegradable propylene (i.e. polypropylene) to be a polypropylene having biodegradable components with the polypropylene.
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 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 1-3, 9-10, 12-13, 24, 30-33 and 35-38 are rejected under 35 U.S.C. 103 as being unpatentable over Chen (WO 2018/140853 A1; Aug. 2, 2018) in view of Attar (WO 2019/086952 A1; May 9, 2019) and Haugh (Royal College of Surgeons in Ireland, 2009).
Chen throughout the reference teaches transglutaminase treated products. Chen teaches a medical device comprising an implant which comprises a collagen containing tissue matrix and particularly an acellular tissue matrix (claims 1-3). Chen teaches the tissue matrix is particulate acellular tissue matrix (i.e., particles) (claim 13). Chen teaches the tissue matrix is enzymatically treated with transglutaminase (claims 9). The tissue matrix comprises a dermal tissue matrix (claim 6). Chen also teaches the dermal acellular tissue matrices can be from human and porcine dermis (para 0018). The particulate acellular tissue matrix forms a covering over a synthetic mesh substrate and the synthetic substrate comprises polypropylene (polymeric material) (claim 12 and 16). The product includes sheet or any shape, size and configuration based on desired use or clinical indication (para 0025). Chen also teaches the substrate can include synthetic or biologic supporting substrate (para 0034). Chen teaches the composition comprising tissue matrix can be freeze dried before performing stabilization step (which can be dehydrothermal treatment as discussed below) and the tissue matrix can be formed into particles (para 0029-0035). As disclosed in the instant specification, freeze drying creates porosity in the tissue product (para 0051) and since Chen teaches freeze drying the tissue matrix, the tissue matrix coating of Chen would necessarily be porous. Chen teaches transglutaminase is provided in a solution (para 0026). The tissue product can include a substrate material that is coated with or encased with the tissue matrix (see e.g. para 0034). The collagen-containing tissue matrix is a particulate matrix, and wherein attaching the collagen-containing tissue matrix to the synthetic substrate comprises applying a slurry of the collagen-containing tissue matrix to the synthetic substrate. For example, a tissue matrix sponge can be formed by cutting, grinding, or chopping tissue matrix to produce particles or fragments. The particles or fragments can then be formed into a slurry by addition of water and cast in a container (e.g., as a sheet or other shape) or applied to a substrate before drying (e.g., by air or freeze drying). (see e.g. claim 27-29; para 0032).
The teachings of Chen have been set forth above.
Chen does not teach the coating of the composition further comprising a separate at least partially denatured collagen component (gelatin) along with transglutaminase and the acellular tissue matrix particles. Chen does not teach wherein the gelatin, transglutaminase and acellular tissue matrix particles have been mixed to form a slurry. Chen also does not teach the amount of the at least partially denatured collagen (gelatin) as recited in the instant claims. However, this deficiency is cured by Attar.
Attar teaches composition which can be used as scaffold for cells, a tissue remodeling agent and surgical mesh and wherein the composition comprise transglutaminase treated (crosslinked) gelatin which provides scaffolds with improved cell attachment and motility compatibility (para 0142 and 0069-0072). Attar teaches gelatin in the amount of 0.5% to 25% w/w (Para 009-0012). Attar teaches having sufficient amount of gelatin to have Young’s modulus (elasticity) of about 0.5-10 KPa (claim 24). The cross-linkable protein (gelatin) and the cross-linker (transglutaminase) are dry powders, and the dry powders are mixed, and then dissolved. The cross-linkable protein can comprise gelatin but may also, additionally or alternatively, comprise another type of protein. According to some embodiments of the present invention, the protein is also a substrate for transglutaminase. In some embodiments, substrates for transglutaminase may include collagen (see e.g. para 0088-0090; 0099; 0139; 0147; Entire Document).
While Chen and Attar teach the coating is formed by treatment with transglutaminase, Chen and Attar do not teach the coating formed by dehydrothermal treatment as recited in instant claims. However, this deficiency is cured by Haugh.
Haugh teaches the effect of dehydrothermal treatment on the mechanical and structural properties of collagen-GAG scaffold. Haugh teaches that dehydrothermal treatment is a common technique used for stabilizing collagen and collagen composite materials. (Pg. 4, lines 2-3).
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to have modified Chen to incorporate the teachings of Attar and further include transglutaminase treated gelatin and the amount thereof based on teachings of Attar with the acellular tissue matrix of Chen. Both Chen and Attar teach compositions which are mesh and scaffolds and, as discussed supra, Attar teaches transglutaminase treated (crosslinked) gelatin which provides scaffolds with improved cell attachment and motility compatibility. Further, as mentioned above, Attar teaches having a sufficient amount of gelatin provides elasticity. Thus, one skilled in the art would have been motivated to include transglutaminase treated gelatin and the amount taught by Attar with the acellular tissue matrix of Chen because transglutaminase treated gelatin provides scaffolds with improved cell attachment, motility compatibility and elasticity. 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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). With respect to the instantly claimed limitations wherein the gelatin, transglutaminase and acellular tissue matrix particles have been mixed to form a slurry, Chen teaches the collagen-containing tissue matrix is a particulate matrix, and wherein attaching the collagen-containing tissue matrix to the synthetic substrate comprises applying a slurry of the collagen-containing tissue matrix to the synthetic substrate. As discussed supra, Attar teaches the cross-linkable protein (gelatin) and the cross-linker (transglutaminase) are dry powders, and the dry powders are mixed, and then dissolved. The cross-linkable protein can comprise gelatin but may also, additionally or alternatively, comprise another type of protein. According to some embodiments of the present invention, the protein is also a substrate for transglutaminase. In some embodiments, substrates for transglutaminase may include collagen. Thus, it would have been obvious to one skilled in the art to mix transglutaminase and gelatin powder taught by Attar with the slurry of the collagen-containing tissue matrix of Chen because, as mentioned previously, transglutaminase treated gelatin provides scaffolds with improved cell attachment, motility compatibility and elasticity as taught by Attar.
Further, the instant claims are directed to a product and the instantly claimed limitations wherein the gelatin, transglutaminase and acellular tissue matrix particles have been mixed to form a slurry appear to be method steps of making the product. Note MPEP 2113: “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). The MPEP also indicates that “the structure implied by the process steps should be considered when assessing the patentability of product-by-process claims over the prior art, especially where the product can only be defined by the process steps by which the product is made, or where the manufacturing process steps would be expected to impart distinctive structural characteristics to the final product. See, e.g., In re Garnero, 412 F.2d 276, 279, 162 USPQ 221, 223 (CCPA 1979). “In determining validity of a product-by-process claim, the focus is on the product and not the process of making it.” Amgen Inc. v. F. Hoffman-La Roche Ltd., 580 F.3d 1340, 1369 (Fed.Cir.2009). The process of making is only relevant “if the process by which a product is made imparts ‘structural and functional differences' distinguishing the claimed product from the prior art” Greenliant Systems, Inc. v. XicorLLC, 692 F.3d 1261, 1268 (Fed. Cir. 2012). In the instant case, the claims recite a product which comprises a polymeric material and a coating comprising acellular tissue matrix particles, a separate at least partially denatured collagen (gelatin) and transglutaminase, and the coating is applied to the polymeric material. The combination of the cited prior art references render obvious structurally the same product as recited in the instant claims. Thus, even in the case the prior art does not teach the method step of mixing the components to form a slurry, the product taught by prior art still would read on the product instant claimed.
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to have modified Chen to incorporate the teachings of Haugh and further use dehydrothermal treatment to form the coating of Chen. Chen teaches that further stabilization steps to stabilize the tissue material can be performed (Para 0033; 0035) and, as discussed above, Chen also teaches a tissue product comprising collagen material. Haugh teaches that dehydrothermal treatment is a common technique used for stabilizing collagen and collagen composite materials and thus, one skilled in the art would have been strongly motivated to use hydrothermal treatment for stabilizing the tissue product of Chen.
From the combined teaching of the cited references, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Claims 7, 34, 39 and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Chen (WO 2018/140853 A1; Aug. 2, 2018) in view of Attar (WO 2019/086952 A1; May 9, 2019) and Haugh (Royal College of Surgeons in Ireland, 2009) as applied to claims 1-3, 9-10, 12-13, 24, 30-33 and 35-38 above, and further in view of Reves (US 2018/0353654 A1; Dec. 13, 2018).
The teachings of above cited references have been set forth above.
The above cited references do not teach the amount of the acellular tissue matrix particles as recited in the instant claims 7, 34 and 39. However, this deficiency is cured by Reves.
Reves teaches an implant composition wherein the implant comprises acellular tissue matrix in an amount of about 5 wt.% to about 25 wt. %.
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to have modified Chen to incorporate the teachings of Reves and include acellular tissue matrix in the product of Chen in the amount taught by Reves. One would have been motivated to do so because Chen teaches the tissue product is an implant (claim 1) and Reves also teaches the composition being an implant which comprises acellular tissue matrix. Since Chen is silent on the amount of acellular tissue matrix, it would have been obvious to one skilled in the art to look towards to the teachings of Reves for the amount of acellular tissue matrix to add in the product of Chen. 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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
From the combined teaching of the cited references, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Claims 10, 36, 41 are rejected under 35 U.S.C. 103 as being unpatentable over Chen (WO 2018/140853 A1; Aug. 2, 2018) in view of Attar (WO 2019/086952 A1; May 9, 2019), Haugh (Royal College of Surgeons in Ireland, 2009) and Reves (US 2018/0353654 A1; Dec. 13, 2018) as applied to claims 1-3, 7, 9-10, 12-13, 24, 30-33, 34, 35-40 above, and further in view of Tamme (Surg Endosc (2008) 22:1100-1106).
As discussed supra, Chen teaches the substrate can include synthetic or biologic supporting substrate (para 0034). The combination of the previously cited references above do not teach the polymeric material is a biodegradable synthetic polymer and specifically a biodegradable polypropylene mesh. However, Tamme cures this deficiency.
Tamme teaches polypropylene mesh containing an absorbable (i.e. biodegradable) component consisting of poliglecaprone. Stabilization of the mesh by the addition of an absorbable component improves its handling properties, particularly in placement of the mesh during endoscopic inguinal hernia repair. (see e.g. Abstract; Results; Entire Document).
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to have modified Chen to incorporate the teachings of Tamme and utilize the polypropylene mesh containing an absorbable (i.e. biodegradable) component consisting of poliglecaprone. One would have been motivated to do so because, as discussed supra, Chen teaches the particulate acellular tissue matrix forms a covering over a synthetic mesh substrate and the synthetic substrate comprises polypropylene, and Tamme teaches stabilization of the mesh by the addition of an absorbable component improves its handling properties, particularly in placement of the mesh during endoscopic inguinal hernia repair. As mentioned previously, for the purpose of examination, the examiner interprets a biodegradable propylene (i.e. polypropylene) to be a polypropylene having biodegradable components with the polypropylene. Thus, polypropylene mesh containing an absorbable (i.e. biodegradable) component consisting of poliglecaprone reads on the claimed biodegradable polypropylene mesh.
From the combined teaching of the cited references, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Response to Arguments
Applicant argued Chen never discusses mixing the particles with transglutaminase such that the particles are affected by the transglutaminase other than to treat the surface of a tissue matrix formed from the particles. Claims 13 and 14 of Chen recite "particulate acellular tissue matrix" but refer to the "particulate acellular tissue matrix" as the "collagen-containing tissue matrix" that is the "main body," not the coating treated with transglutaminase. So, although Chen refers to particulate tissue matrix, Chen does not suggest treating the particles with transglutaminase to produce a coating over a polymeric material, as claimed in the present application.
In response, Chen teaches the tissue product will include a main body portion including a collagen-containing tissue product with one or more surfaces that can be treated to include a region having a transglutaminase coating or section of matrix that has been treated to enzymatically alter the tissue matrix. A tissue matrix can be formed by cutting, grinding, or chopping tissue matrix to produce particles or fragments. The particles or fragments can then be formed into a slurry by addition of water and cast in a container (e.g., as a sheet or other shape) or applied to a substrate. The collagen-containing tissue matrix is a particulate matrix, and wherein attaching the collagen-containing tissue matrix to the synthetic substrate comprises applying a slurry of the collagen-containing tissue matrix to the synthetic substrate. (para 0025; 0032; claim 27). Thus, Chen does teach a slurry/particulates of collagen-containing tissue matrix and including transglutaminase which treats/coats at least a portion of the surface of the tissue matrix.
Applicant argued while Chen discusses treating the tissue matrix with transglutaminase, Chen’s teaching is limited to treatment of the surface region only. The claims require treatment of more than the surface of the tissue matrix because claims require the tissue matrix particles and at least partially denatured collagen have been mixed with a transglutaminase and applied to polymeric material. Mixing tissue matrix particles and denatured collagen with transglutaminase would necessarily result in the treatment of the product with transglutaminase throughout, not merely the surface. Applicant argued that inferring the addition of transglutaminase other than on the surface of the tissue matrix constitutes impermissible hindsight.
In response, as discussed supra, Chen teaches the collagen-containing tissue matrix is a particulate matrix, and wherein attaching the collagen-containing tissue matrix to the synthetic substrate comprises applying a slurry of the collagen-containing tissue matrix to the synthetic substrate. Attar teaches the cross-linkable protein (gelatin) and the cross-linker (transglutaminase) are dry powders, and the dry powders are mixed, and then dissolved. The cross-linkable protein can comprise gelatin but may also, additionally or alternatively, comprise another type of protein. According to some embodiments of the present invention, the protein is also a substrate for transglutaminase. In some embodiments, substrates for transglutaminase may include collagen. Thus, it would have been obvious to one skilled in the art to mix transglutaminase and gelatin powder taught by Attar with the slurry of the collagen-containing tissue matrix of Chen because, as mentioned previously, transglutaminase treated gelatin provides scaffolds with improved cell attachment, motility compatibility and elasticity as taught by Attar. Therefore, as per applicant’s own assertion, Mixing tissue matrix particles and denatured collagen with transglutaminase would necessarily result in the treatment of the product with transglutaminase throughout, not merely the surface. Further, Chen teaches a transglutaminase coating disposed on at least a portion of the outer surface of the tissue matrix. Chen does not teach away or suggest that transglutaminase has to be limited to the surface of the tissue matrix.
Applicant also argued that Chen describes tissue matrix materials perform biological processes suggested as advantages of the gelatin described by Attar and an obviousness rejection is improper when the proposed modification amounts to extra work and greater expense for no apparent reason. The one advantage not discussed in Chen, the elasticity described by Attar, is specific to the combination of gelatin and processing described by Attar. Elasticity is not a general property that would be gained by adding gelatin to another material like Chen.
In response, applicant’s attention is respectfully drawn to MPEP 2144.06: As a general principle it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose, the idea of combining them flows logically from their having been individually taught in the prior art. See In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) MPEP 2144.06. Therefore, combining the tissue matrix material of Chen and gelatin of Attar having similar or equivalent biological processes (i.e., having functional equivalence) would have been prima facie obvious to one of ordinary skill in the art. In response to this, Applicant also appear to make the argument that Chen and Attal are not useful for the very same purpose. It is argued that the examiner made this argument because applicant state that the advantages of gelatin taught in Attar are already described in Chen. Thus, this suggests that both Chen and Attar are directed to products which have same advantages or functions. Thus, applicant’s two different arguments appears to be conflicting.
Further, Attar teaches that “In some embodiments utilizing gelatin, the cross-linked gelatin's elastic properties, as well as the abundance of integrin attachment sites (cell binding sites on the polymer) allow for cell ingrowth, proliferation and result in physiological tissue regeneration and enable various tissue engineering applications” (see e.g. para 0177). Thus, Attar is clearly referring the gelatin having and providing elasticity properties which provide for the benefits described by Attar with use of gelatin in scaffold products. The applicant have not provided any evidence as to why the elasticity provided by gelatin in Attar would not occur in Chen.
Applicant reiterated the argument that Chen teaches the coating provides one of an anti-adhesion or anti-abrasion property to the outer surface. In contrast, Attar is directed to a composition that promotes adhesion and modifying Chen with the teachings of Attar would render Chen unsatisfactory for its intended purposes.
In response, as acknowledged by applicant, Chen teaches the coating provides one of an anti-adhesion or anti-abrasion property, which suggests that only one of these said properties is required (e.g., either anti-adhesion or anti-abrasion). Therefore, Chen does not require the coating to have an anti-adhesion property.
The applicant in response to examiner’s remarks argued that Chen separately discussed an alternate embodiment that may include particulate matrix slurry that is dried on a substrate. Chen does not teach adding transglutaminase to the slurry. Transglutaminase is applied after the main body (tissue matrix) is formed.
In response, as discussed supra, Chen teaches the collagen-containing tissue matrix is a particulate matrix, and wherein attaching the collagen-containing tissue matrix to the synthetic substrate comprises applying a slurry of the collagen-containing tissue matrix to the synthetic substrate. As discussed supra, Attar teaches the cross-linkable protein (gelatin) and the cross-linker (transglutaminase) are dry powders, and the dry powders are mixed, and then dissolved. The cross-linkable protein can comprise gelatin but may also, additionally or alternatively, comprise another type of protein. According to some embodiments of the present invention, the protein is also a substrate for transglutaminase. In some embodiments, substrates for transglutaminase may include collagen. Thus, it would have been obvious to one skilled in the art to mix transglutaminase and gelatin powder taught by Attar with the slurry of the collagen-containing tissue matrix of Chen because, as mentioned previously, transglutaminase treated gelatin provides scaffolds with improved cell attachment, motility compatibility and elasticity as taught by Attar.
Further, the instant claims are directed to a product and the instantly claimed limitations wherein the gelatin, transglutaminase and acellular tissue matrix particles have been mixed to form a slurry appear to be method steps of making the product. Note MPEP 2113: “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). The MPEP also indicates that “the structure implied by the process steps should be considered when assessing the patentability of product-by-process claims over the prior art, especially where the product can only be defined by the process steps by which the product is made, or where the manufacturing process steps would be expected to impart distinctive structural characteristics to the final product. See, e.g., In re Garnero, 412 F.2d 276, 279, 162 USPQ 221, 223 (CCPA 1979). “In determining validity of a product-by-process claim, the focus is on the product and not the process of making it.” Amgen Inc. v. F. Hoffman-La Roche Ltd., 580 F.3d 1340, 1369 (Fed.Cir.2009). The process of making is only relevant “if the process by which a product is made imparts ‘structural and functional differences' distinguishing the claimed product from the prior art” Greenliant Systems, Inc. v. XicorLLC, 692 F.3d 1261, 1268 (Fed. Cir. 2012). In the instant case, the claims recite a product which comprises a polymeric material and a coating comprising acellular tissue matrix particles, a separate at least partially denatured collagen (gelatin) and transglutaminase, and the coating is applied to the polymeric material. The combination of the cited prior art references render obvious structurally the same product as recited in the instant claims. Thus, even in the case the prior art does not teach the method step of mixing the components to form a slurry, the product taught by prior art still would read on the product instant claimed.
Applicant argued that Chen’s teaching is limited to treatment of the surface region only. The claims require treatment of more than the surface of the tissue matrix because claims require the tissue matrix particles and at least partially denatured collagen have been mixed with a transglutaminase and applied to polymeric material. Mixing tissue matrix particles and denatured collagen with transglutaminase would result in the treatment of the product with transglutaminase throughout, not merely the surface.
In response, as discussed supra, Chen teaches the collagen-containing tissue matrix is a particulate matrix, and wherein attaching the collagen-containing tissue matrix to the synthetic substrate comprises applying a slurry of the collagen-containing tissue matrix to the synthetic substrate. Attar teaches the cross-linkable protein (gelatin) and the cross-linker (transglutaminase) are dry powders, and the dry powders are mixed, and then dissolved. The cross-linkable protein can comprise gelatin but may also, additionally or alternatively, comprise another type of protein. According to some embodiments of the present invention, the protein is also a substrate for transglutaminase. In some embodiments, substrates for transglutaminase may include collagen. Thus, it would have been obvious to one skilled in the art to mix transglutaminase and gelatin powder taught by Attar with the slurry of the collagen-containing tissue matrix of Chen because, as mentioned previously, transglutaminase treated gelatin provides scaffolds with improved cell attachment, motility compatibility and elasticity as taught by Attar. Therefore, mixing tissue matrix particles and denatured collagen with transglutaminase would necessarily result in the treatment of the product with transglutaminase throughout, not merely the surface. Further, Chen teaches a transglutaminase coating disposed on at least a portion of the outer surface of the tissue matrix. Chen does not teach away or suggest that transglutaminase has to be limited to the surface of the tissue matrix.
Applicant again appear to argue that Chen describes tissue matrix materials perform biological processes suggested as advantages of the gelatin described by Attar and an obviousness rejection is improper when the proposed modification amounts to extra work and greater expense for no apparent reason. The one advantage not discussed in Chen, the elasticity described by Attar, is specific to the combination of gelatin and processing described by Attar. Elasticity is not a general property that would be gained by adding gelatin to another material like Chen. Applicant argue that the product of Chen has an implant main body portion with a transglutaminase coating, significantly different in structure from the crosslinked gelatin in Attar. The varying structures allow for vastly different practical applications.
In response, applicant’s attention is again respectfully drawn to MPEP 2144.06: As a general principle it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose, the idea of combining them flows logically from their having been individually taught in the prior art. See In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) MPEP 2144.06. Therefore, combining the tissue matrix material of Chen and gelatin of Attar having similar or equivalent biological processes (i.e., having functional equivalence) would have been prima facie obvious to one of ordinary skill in the art. In response to this, Applicant appear to make the argument that that the product of Chen has an implant main body portion with a transglutaminase coating, significantly different in structure from the crosslinked gelatin in Attar. The varying structures allow for vastly different practical applications. It is again reiterated that the examiner made this argument because applicant state that the advantages of gelatin taught in Attar are already described in Chen. Thus, this suggests that both Chen and Attar are directed to products which have same advantages or functions. Further, Attar teaches that “In some embodiments utilizing gelatin, the cross-linked gelatin's elastic properties, as well as the abundance of integrin attachment sites (cell binding sites on the polymer) allow for cell ingrowth, proliferation and result in physiological tissue regeneration and enable various tissue engineering applications” (see e.g. para 0177). Thus, Attar is clearly referring the gelatin having and providing elasticity properties which provide for the benefits described by Attar with use of gelatin in scaffold products and one of ordinary skill in the art would expect that addition of gelatin in combination with transglutaminase to tissue matrix of Chen would provide elasticity.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-3, 7, 9-10, 12-13, 24 and 30-41 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of copending Application No. 19/088,161 in view of Owens et al. (US 9,382,422 B2; Ju. 5, 2016) (previously cited), Haugh (Royal College of Surgeons in Ireland, 2009), Attar (WO 2019/086952 A1; May 9, 2019), and Reves (US 2018/0353654 A1; Dec. 13, 2018).
The ‘161 application claims treatment composition comprising a group of dermal acellular tissue matrix particles, transglutaminase and gelatin. ‘161 recites the composition comprises 5-15% of gelatin. Also, the composition comprises about 8% of dermal acellular tissue matrix particles. The composition adheres to surrounding tissues and the tissue matrix particles comprise a slurry. The composition comprises 5 to 7.5 units per milliliter of transglutaminase.
The ‘161 application does not claim the composition comprising a polymeric material to be coated and wherein the polymeric material is polypropylene. However, this deficiency is cured by Owens.
Owens is also directed to acellular tissue matrix compositions for tissue repair and Owens teaches coating the composition on substrate wherein the substrate is polypropylene. Owens also teaches composite meshes, i.e., meshes that include both absorbable and non-absorbable materials can be made polypropylene/cellulose. (Claims 1 and 28-33; Summary; col. 13, line 45-55).
‘161 does not teach a coating formed by dehydrothermal treatment. However, this deficiency is cured by Haugh.
Haugh teaches the effect of dehydrothermal treatment on the mechanical and structural properties of collagen-GAG scaffold. Haugh teaches that dehydrothermal treatment is a common technique used for stabilizing collagen and collagen composite materials. (Pg. 4, lines 2-3).
‘161 does not teach the amount of transglutaminase as recited in the instant claims. However, this deficiency is cured by Attar.
Attar teaches composition which can be used as scaffold for cells, a tissue remodeling agent and bio-adhesive (Para 142) and wherein the composition comprise transglutaminase in the amount of 0.0001% to 2% w/w and gelatin in the amount of 0.5% to 25% w/w (Para 009-0012).
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to have modified ‘161 to incorporate the teachings of Owens and coat the treatment product of ‘161 onto polymeric substrate which is made of polypropylene or an absorbable and non-absorbable materials made polypropylene/cellulose. One would have been motivated to do so because both ‘161 and Owens are directed to tissue treatment and Owens teaches that coating these treatment composition onto polymeric substrate was known in the art and thus it would have been obvious to combine the teachings of ‘161 and Owens to coat the treatment composition onto a polymeric substrate.
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to have modified ‘161 to incorporate the teachings of Haugh and further use dehydrothermal treatment in the composition of ‘161. Haugh teaches that dehydrothermal treatment is a common technique used for stabilizing collagen and collagen composite materials and one skilled in the art would have been strongly motivated to use hydrothermal treatment for stabilizing the composition of ‘161 which also contains collagen.
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to have modified ‘161 to incorporate the teachings of Attar and include transglutaminase in the amount taught by Attar because Attar discloses that the claimed amounts of transglutaminase were known in the art. 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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
From the combined teaching of the cited references, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant argued the claims of ‘161 application do not recite the use of a polymeric material or a coating.
In response, it would have been prima facie obvious to coat the treatment product of ‘161 onto polymeric substrate which is made of biodegradable synthetic polymer (polypropylene-celluose) because both ‘161 and Owens are directed to tissue treatment and Owens teaches that coating these treatment composition onto polymeric substrate was known in the art and thus it would have been obvious to combine the teachings of ‘161 and Owens to coat the treatment composition onto a polymeric substrate.
Conclusion
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/ALI S SAEED/Examiner, Art Unit 1616
Prosecution Insights