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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Acknowledgment is made of applicants' claim for foreign priority to European applications 22305597.1 filed on 04/21/2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/18/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Product by Process claims
It is noted that claims 12 and 16 are directed to a product by process. Product by process limitations are only given patentable weight to the extent that the process imparts a structural or functional distinction in the leather as compared to the prior art. Accordingly the process limitations do not distinguish the claimed product from the leather disclosed in the prior art.
Claim Rejections - 35 USC § 112
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.
Claim 6 is 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.
Regarding claim 6: The specification particularly at [0157] indicated that the average Young’s modulus was 40.80±14.21kPa. This comes to 26.59 to 55.01 kPa. This falls outside of the claimed range of Young’s modulus of 5 to 1 MPa. As such it is noted that the specification provided no support for the claimed range of Young’s modulus of the polymeric scaffold and the application lacks written description for the claimed range.
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 11 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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.
Claim 11 requires a bioactive molecule such as glycosaminoglycan. The phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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 1-3, 5-6, 9, 12, 16, 18 and 20, are rejected under 35 U.S.C. 103 as being unpatentable over Purcell et al (WO2017053433A1; Published March 30, 2017; hereinafter "Purcell;" See IDS 10/18/2024) in view of Shortkroff et al (US9149562B2; Published October 6, 2015; hereinafter " Shortkroff;" See PTO-892) and Gil (J Biomed Mater Res A. 2011 Oct; hereinafter “Gil;” See PTO 892).
Regarding claim 1-3, 5, 12, 16, 18 and 20: Purcell taught a method of forming an engineered, reinforced leather material (engineered leather) in a composite of a fibrous matrix and tanning to allow crosslinking of the fibrous matrix to the collagen formed by cultured cells (e.g., fibroblasts). (See Purcell Abstract). Claim 1 of Purcell taught “culturing cells on a fibrous scaffold until fibers of the fibrous scaffold are surrounded by tissue comprising extracellular matrix at a density of greater than about 200,000 cells/cm2 of substrate surface area, forming a tissue construct; and tanning the tissue construct to form a fiber reinforced leather-like material.” Claims 8 and 9 of Purcell taught culturing cells on a synthetic fiber scaffold that facilitates cell attachment and tissue growth, wherein the synthetic scaffold can be a polyester scaffold. In addition, claim 12 of Purcell taught a fibrous scaffold having a porosity of between 10 and 99%. [00020] of Purcell also noted that the “tensile strength of the fiber-reinforced biological tissue composite material is greater than about 1.0 MPa.” It is also noted that [00071] of Purcell taught that “[g]ood adhesion is demonstrated when the sample has a tensile strength of at least 1 MPa.” It is noted that Purcell did not teach the claimed honeycomb microporous polymeric scaffold with macropores of diameter between 100 nm and 280 micrometer and a pore wall thickness below 70 micrometer.
Shortkroff taught “method for preparing an implant for tissue or cartilage repair, the method comprising the steps of: providing an acellular, three-dimensional scaffold comprising collagen and defining a plurality of pores.” (See Shortkroff claim 1). Claim 2 of Shortkroff taught that “acellular, three-dimensional collagen scaffold comprises a sponge, a honeycomb or honeycomb-like scaffold, or a thermo-reversible hydrogel.” Shortkroff taught that “[d]epending on the tissue to be repaired, the pore size of the primary and/or secondary scaffold will vary. For example, cartilage scaffolds would have an optimal pore size of approximately 200 μm and bone would have a pore size in the range of 300 to 350 μm.” (See Shortkroff col. 17, lines 10-30). Accordingly, a person of ordinary skill in the art seeking to implement the scaffold-based engineered-leather process of Purcell would have been motivated to employ a known tissue-engineering honeycomb scaffold such as that taught in Shortkroff, as scaffold on which fibroblasts are cultured. Both Purcell and Shortkroff recognized the importance of porous scaffold structures for supporting tissue growth and Shortkroff expressly taught a honey-comb architecture having defined pore dimensions. The substitution would therefore have been the use of a known scaffold architecture for a known purpose in Purcell’s known fibroblast-based tissue-generation process.
Shortkroff did not teach or expressly disclose the claimed pore area distribution and pore wall thickness. Gil supplied this teaching. Gil was directed to “[l]oad bearing porous biodegradable scaffolds are required to engineer functional tissues such as bone.” (See Gill Abstract). Gil taught that wall thickness of the scaffold are designed to have interconnected pores where new bone tissue regeneration can be integrated with adequate neovascularization and nutrient/metabolic waste diffusion. (See Gil p.6, para 2). Gil further taught pore sizes of 260-270 micrometer and wall thickness of 6-25 micrometer. (See Table 1). Thus Gil taught that pore sizes, porosity, and wall thickness are tunable scaffold design parameter rather than fixed or incidental characteristics. A person of ordinary skill would therefore have had reason to adjust the pore dimensions, pore distribution and wall thickness as taught by Gil and Shortkroff to provide a scaffold having suitable properties for fibroblast infiltration and tissue growth. It is submitted that selecting appropriate dimensions would have been routine optimization of result effective variables to obtain desired scaffold architecture and tissue growth characteristics. The combination would therefore have provided a method in which fibroblasts are cultured on a honeycomb macroporous polymeric scaffold having selected pore dimensions, pore distribution, and wall thickness, followed by tanning of the resulting tissue to produce leather. The skilled artisan would have had a reasonable expectation of success because Purcell already demonstrates that fibroblast-containing tissue constructs can be formed on polymeric scaffolds and subsequently tanned into leather-like materials, while Shortkroff and Gil provide known porous-scaffold architectures and fabrication principles for controlling pore dimensions and wall thickness.
Regarding claim 3: The teachings of Purcell in view of Shortkroff and Gil are set forth above. None of the cited materials particularly taught that the concentration of polyester should be within 1-50%. However, Gil teaches that the concentration and amount of scaffold material can be varied to control scaffold architecture and properties. In particular, Gil teaches that wall thickness, density, and porosity are tunable by varying the silk concentration and the amount of silk particles used in forming the scaffold. Thus, Gil demonstrates that scaffold-material concentration is a result-effective variable that may be optimized to obtain desired scaffold properties.
In view of this teaching, it would have been obvious to a person of ordinary skill in the art to optimize the concentration of the polyester scaffold material of Purcell to obtain desired scaffold properties, such as porosity, wall thickness, density, and tissue growth characteristics. Selection of a suitable concentration within the claimed range of 1–50% (w/w) would have constituted routine optimization of a known result-effective variable. No particular criticality or unexpected result associated with the recited concentration range has been established.
Regarding claim 6: Gil taught hat “to fabricate fibrous protein-based scaffolds with tunable pore size, porosity, density, and mechanical robustness suggest new and important options for robust porous polymeric biomaterials for tissue repair for osteoregenerative applications, as the values are in the same order of magnitude.” (See Gil; p. 9, first para). In Gil “elastic modulus was calculated based on a linear regression fitting of a small strain section that precedes an identifiable plateau region. The compressive yield strength was determined using an offset-yield approach. A line was drawn parallel to the modulus line, but offset by 0.5% of the initial sample gauge length. The corresponding stress value at which the offset line crossed the stress-strain curve was defined as the compressive yield strength of the scaffold, and is an estimate of the linear elastic and collapse plateau transition point.” (See Gil; p. 5, first para). In essence Gil established that scaffold composition and processing parameters can be adjusted to obtain a desired modulus and corresponding mechanical properties. In view of this teaching, a person of ordinary skill in the art would have been motivated to optimize the composition and architecture of the scaffold of Purcell to obtain a desired mechanical stiffness suitable for fibroblast growth and formation of tissue constructs. Selecting a scaffold having a Young’s modulus within the claimed range would have constituted routine optimization of a known scaffold property variable.
Regarding claim 9: Shortkroff taught that primary scaffold has a defined porosity and uniformly distributed pores, providing reasonable basis for substantially uniform/symmetric structure. (col. 25; lines 45-55).
Claims 4, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Purcell et al (WO2017053433A1; Published March 30, 2017; hereinafter "Purcell;" See IDS 10/18/2024) in view of Shortkroff et al (US9149562B2; Published October 6, 2015; hereinafter " Shortkroff;" See PTO-892) and Gil (J Biomed Mater Res A. 2011 Oct; hereinafter “Gil;” See PTO 892) further in view of Sosnowski et al (Macromol. Biosci. ; hereinafter “Sosnowski;” See PTO-892)
Regarding claims 4 and 21: The teachings of Purcell in view of Shortkroff and Gil are set forth above. None of the cited prior art particularly taught macropores interconnected with micropores. Sosnowski was directed to a method for the preparation of porous poly(L-lactide)/poly[(L-lactide)-co-glycolide] scaffolds for tissue engineering. (See Sosnowski Abstract). Sosnowski taught the use of “[l]arge pores, susceptible for osteoblasts growth and proliferation had the dimensions 50–400 µm. Small pores, dedicated to the diffusion of nutrients or/and metabolites of bone forming cells, as well as the products of hydrolysis of polyesters from the walls of the scaffold, had sizes in the range 2 nm–5 µm.“ (See Sosnowski Abstract).
Accordingly, a person of ordinary skill in the art would have been motivated to modify the porous scaffold of Purcell and Shortkroff in view of the teachings of Sosnowski to provide interconnected pores having different size scales. Such modification would have been expected to facilitate cell infiltration, tissue growth and transport of nutrients and metabolic waste through scaffold.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Purcell et al (WO2017053433A1; Published March 30, 2017; hereinafter "Purcell;" See IDS 10/18/2024) in view of Shortkroff et al (US9149562B2; Published October 6, 2015; hereinafter " Shortkroff;" See PTO-892) and Gil (J Biomed Mater Res A. 2011 Oct; hereinafter “Gil;” See PTO 892) further in view of Kang et al (Macromol Res. 2020; hereinafter “Kang;” See IDS 10/18/2024).
Regarding claim 7: The teachings of Purcell in view of Shortkroff and Gil are set forth above. None of the cited prior art particularly taught a method of producing the scaffold using Non-Solvent-Induced Phase Separation.
However, Kang taught that “[h]ighly porous poly(3-hydroxybutyrate) (PHB) scaffolds were fabricated using non-solvent-induced phase separation with chloroform as the solvent and tetrahydrofuran as the non-solvent. The microporosity, nanofiber morphology, and mechanical strength of the scaffolds were adjusted by varying the fabrication parameters, such as the polymer concentration and solvent composition.” (See Kang Abstract). As such, such methods were routine in the art for the production of porous scaffolds for tissue engineering.
As such a person of ordinary skill in the art would have been motivated to employ NIPS to manufacture the claimed scaffold as these were well known techniques for manufacturing of scaffold at the time of filing of instant application. It is also noted that Kang taught “superior cell viability and the controlled scaffold properties and morphologies suggested PHB scaffolds fabricated by non-solvent-induced phase separation using chloroform and tetrahydrofuran as promising biomaterials for the applications of tissue engineering” (See Kang Abstract), thus motivating a person of ordinary skill in the art to produce the scaffold by the claimed method.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Purcell et al (WO2017053433A1; Published March 30, 2017; hereinafter "Purcell;" See IDS 10/18/2024) in view of Shortkroff et al (US9149562B2; Published October 6, 2015; hereinafter " Shortkroff;" See PTO-892) and Gil (J Biomed Mater Res A. 2011 Oct; hereinafter “Gil;” See PTO 892) further in view of Tawil et al (European Polymer Journal, 2018; hereinafter “Tawil;” See IDS 10/18/2024).
Regarding claim 8: The teachings of Purcell in view of Shortkroff and Gil are set forth above. None of the cited prior art particularly taught a method of producing the scaffold with first face comprising macropores and second opposite face comprising nanopores and the diameter of nanopores being less than 10 nm.
Tawil taught NIPS as a process to prepare “3D porous scaffolds for tissue engineering in the form of asymmetric membranes with a nanoporous face allowing the diffusion of soluble compounds and gases and a macroporous face allowing the cells to penetrate inside the scaffold. Tawil taught that these “membranes showed a high porosity, a nano porous top surface and a bottom surface with macropores open to the surface whose diameter was large enough to allow the cells to enter into the scaffold and colonize it.” (See Tawari p. 371, col.1, last para). It is noted that Tawil taught macropores of diameter of 220.0 ± 7.6μm (See Tawil p. 375, col. 1 last para) and nanopores of 344 ± 2nm, 590 ± 4nm and 731 ± 8nm (See Tawil p. 375, col. 2, first para). It is noted that Tawil did not teach a nanopore size of 10nm or less. The claimed value of less than 10 nm is therefore considered an optimized pore-size parameter within a known range of scaffold pore dimensions. Absent evidence that the particular 10 nm threshold produces an unexpected result or other criticality relative to the prior-art pore-size ranges, the selection of the claimed pore-size range would have been within the routine skill of the art.
Claims 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Purcell et al (WO2017053433A1; Published March 30, 2017; hereinafter "Purcell;" See IDS 10/18/2024) in view of Shortkroff et al (US9149562B2; Published October 6, 2015; hereinafter " Shortkroff;" See PTO-892) and Gil (J Biomed Mater Res A. 2011 Oct; hereinafter “Gil;” See PTO 892) further in view of Kim et al (Biomater Res. 2016 Jul 27 ; hereinafter “Kim;” See PTO-892)
Regarding claims 10-11: The teachings of Purcell in view of Shortkroff and Gil are set forth above. None of the cited prior art particularly taught bioactive material grafted scaffolds as required by the claim.
Kim was directed to porous scaffolds for bone reconstruction. Kim used high-density polyethylene (HDPE) and poly(ethylene-co-acrylic acid) (PEAA) as the polymer composites for producing a porous scaffold of high mechanical strength and having high reactivity with biomaterials such as collagen. (See Kim Abstract). “Owing to the carboxylic acids on PEAA, collagen was successfully grafted onto the porous HDPE/PEAA scaffold, which was confirmed by FT-IR spectroscopy and electron spectroscopy for chemical analysis. Osteoblasts were cultured on the collagen-grafted porous scaffold” (See Kim Abstract).
It would have been obvious to a person of ordinary skill in the art to modify the porous scaffold of Purcell as informed by Shrotkroff and Gil, by grafting collagen at the scaffold surface as taught by Kim. Such modification would have provided a predictable means of functionalizing the scaffold surface to promote desirable biological interactions, including cell adhesion and tissue growth.
Claims 13-14, 17 are rejected under 35 U.S.C. 103 as being unpatentable over Purcell et al (WO2017053433A1; Published March 30, 2017; hereinafter "Purcell;" See IDS 10/18/2024) in view of Shortkroff et al (US9149562B2; Published October 6, 2015; hereinafter " Shortkroff;" See PTO-892) and Gil (J Biomed Mater Res A. 2011 Oct; hereinafter “Gil;” See PTO 892) further in view of Tang et al (J. Agric. Food Chem. (2003); hereinafter “Tang;” See PTO-892) and Wells et al (J Sci Food Agric. 2017 Mar; hereinafter “Wells;” See PTO-892)
Regarding claims 13-14 and 17: The teachings of Purcell in view of Shortkroff and Gil are set forth above. None of the cited prior art particularly taught a tissue having at least two denaturation temperatures as determined by DSC.
Tang was directed to a differential scanning calorimetry (DSC) study of the sheepskin collagen samples treated with hydrolyzable tannins. Tang taught that “The samples treated with other tannins all showed multiple peak DSC profiles with the fwhh of each peak at about 3-4 degrees C. These multiple peak profiles imply that in these polyphenol-treated samples, there is a distribution of collagen molecules having different hydrothermal stability. The results have demonstrated that DSC offers an objective method to detect the stability heterogeneity of collagen matrixes in the solid state” (See Tang Abstract).
It would have been obvious for a person of ordinary skill in the art to expect at least two denaturation temperatures for a tanned leather composition as required by the claim as measured by DSC in view of the teachings of Tang.
It is further noted that Wells taught that leathers tend to be isotropic based on their tightness. (See Wells Abstract). It would have been obvious for a person of ordinary skill in the art to expect at least two denaturation temperatures for a tanned leather composition to be isotropic.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Purcell et al (WO2017053433A1; Published March 30, 2017; hereinafter "Purcell;" See IDS 10/18/2024) in view of Shortkroff et al (US9149562B2; Published October 6, 2015; hereinafter " Shortkroff;" See PTO-892) and Gil (J Biomed Mater Res A. 2011 Oct; hereinafter “Gil;” See PTO 892) further in view of Li et al (Journal of Cleaner Production.. (2020); hereinafter “Li;” See PTO-892)
Li was directed to developing a “surfactant-free beamhouse processing technology by removing the hydrolysis products of grease catalyzed by lipase.” (See Li Abstract). Li indicated that “[a]s one of the pivotal processes in leather manufacturing, degreasing is especially substantial for fatty skins. Surfactant was the pollution of increasing concern in degreasing process due to the large amount of degreasing agents used in conventional degreasing process.“ (See Li Abstract).
Accordingly, reducing residual fatty-acid content during leather processing was a known objective and predictable consequence of removing noncollagenous fatty components.
It therefore would have been obvious to one of ordinary skill in the art practicing Purcell's tanning process to employ conventional leather-processing conditions that remove residual fatty materials, thereby reducing the fatty-acid content of the resulting leather-like tissue. Selecting processing conditions sufficient to reduce residual fatty acids below 1% of the total dry tissue mass would have been a routine optimization of a known compositional property of leather and would have been expected to result from removal of noncollagenous fatty components during tanning and associated processing.
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.
Claim 1-18, 20-21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 17-36 of copending Application No. 18/834,687 (reference application) in view of Shortkroff et al (US9149562B2; Published October 6, 2015; hereinafter " Shortkroff;" See PTO-892) and Gil (J Biomed Mater Res A. 2011 Oct; hereinafter “Gil;” See PTO 892).
Although the claims are not identical, they are not patentably distinct from each other because of the reasons listed below.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding claim 1: Claim 1 of the reference application is directed to a method for producing leather comprising the steps of:
a) culturing fibroblasts in vitro on a macroporous polymeric scaffold wherein said scaffold comprises macropores of diameter comprised between 60 and 500 μm. to obtain a tissue,
b) tanning said tissue thereby forming said leather.
It is noted that the reference application did not teach a honeycomb scaffold. However, Shortkroff taught “method for preparing an implant for tissue or cartilage repair, the method comprising the steps of: providing an acellular, three-dimensional scaffold comprising collagen and defining a plurality of pores.” (See Shortkroff claim 1). Claim 2 of Shortkroff taught that “acellular, three-dimensional collagen scaffold comprises a sponge, a honeycomb or honeycomb-like scaffold, or a thermo-reversible hydrogel.” Shortkroff taught that “[d]epending on the tissue to be repaired, the pore size of the primary and/or secondary scaffold will vary. For example, cartilage scaffolds would have an optimal pore size of approximately 200 μm and bone would have a pore size in the range of 300 to 350 μm.” (See Shortkroff col. 17, lines 10-30). Accordingly a person of ordinary skill in the art seeking to implement the scaffold-based engineered-leather process of Purcell would have been motivated to employ a known tissue-engineering honeycomb scaffold such as that taught in Shortkroff, as scaffold on which fibroblasts are cultured. Both Purcell and Shortkroff recognized the importance of porous scaffold structures for supporting tissue growth and Shortkroff expressly taught a honey-comb architecture having defined pore dimensions. The substitution would therefore have been the use of a known scaffold architecture for a known purpose in Purcell’s known fibroblast-based tissue-generation process.
Shortkroff did not teach or expressly disclose the claimed pore area distribution and pore wall thickness. Gil supplied this teaching. Gil was directed to “[l]oad bearing porous biodegradable scaffolds are required to engineer functional tissues such as bone.” (See Gill Abstract). Gil taught that wall thickness of the scaffold are designed to have interconnected pores where new bone tissue regeneration can be integrated with adequate neovascularization and nutrient/metabolic waste diffusion. (See Gil p.6, para 2). Gil further taught pore sizes of 260-270 micrometer and wall thickness of 6-25 micrometer. (See Table 1). Thus Gil taught that pore sizes, porosity, and wall thickness are tunable scaffold design parameter rather than fixed or incidental characteristics. A person of ordinary skill would therefore have had reason to adjust the pore dimensions, pore distribution and wall thickness as taught by Gil and Shortkroff to provide a scaffold having suitable properties for fibroblast infiltration and tissue growth. It is submitted that selecting appropriate dimensions would have been routine optimization of result effective variables to obtain desired scaffold architecture and tissue growth characteristics. The combination would therefore have provided a method in which fibroblasts are cultured on a honeycomb macroporous polymeric scaffold having selected pore dimensions, pore distribution, and wall thickness, followed by tanning of the resulting tissue to produce leather. The skilled artisan would have had a reasonable expectation of success because Reference Application already demonstrates that fibroblast-containing tissue constructs can be formed on polymeric scaffolds and subsequently tanned into leather-like materials, while Shortkroff and Gil provide known porous-scaffold architectures and fabrication principles for controlling pore dimensions and wall thickness.
Claim 1-18, 20-21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 17-36 of copending Application No. 18/834,687 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because of the reasons indicated below.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 12 and 16 are anticipated by claim 36 of the reference application.
Conclusion
No claim is free of art.
No claim is allowed.
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/JAGAMYA NMN VIJAYARAGHAVAN/Examiner, Art Unit 1633
/EVELYN Y PYLA/Primary Examiner, Art Unit 1633
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