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 .
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.
Election/Restrictions
Applicant's election without traverse of Group I, claims 2-11, in the reply filed on 06/18/2026 is acknowledged.
Claims 12-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim Rejections - 35 USC § 102
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 2-3 and 6-7 are rejected under 35 U.S.C. 102 as being as being anticipated by Nasert et al (US 2021/0213166 A1).
Examiner’s Note: “Amalgamated” is defined in the instant specification as “formed from or comprising a plurality of smaller pieces or components” [00011].
Claims 2-3 are anticipated because Nasert discloses an implant formed from cartilage fibers and particles comprising a plurality of cartilage fibers and a plurality of cartilage particles to entangle the plurality of cartilage fibers and cartilage particles to form a mass (reads on “amalgamated”) and produce a cartilage-derived implant having a first shape which when implanted in a shaped cavity of an implant site (which inherently has a size) is capable of conforming to and completely filling the shaped cavity and resists deformation and migration from the shaped cavity upon hydration with a fluid (i.e., the shape is retained after implantation and hydration) (claim 9).
Claims 6 and 7 are anticipated because a chemical composition and its properties are inseparable. MPEP 2112.01 II. The implant of Nasert (claim 9) would be reasonably expected to be capable of being reshaped to a subsequentially selected three-dimensional shape by manual manipulation and then retaining that shape after implanting at a treatment site, especially as Nasert discloses the cartilage derived implant is capable of being intentionally reshaped and shaping is done by manually manipulating to a desired shape (claim 16).
Claims 2-7 are rejected under 35 U.S.C. 102 as being as being anticipated by Yao et al. (US 2009/0012629 A1).
Claims 2-3 are anticipated because at [0051]-[0054], Yao discloses that a mold having sufficient moldability and rigidity (shape memory) is applied by a physician to a cartilage injury. This shaping results in a mold which can be used to form an implant which matches the size and shape of the defect [0051]-[0052]. Then cartilage tissue fragments and storage medium are transferred to the mold (forming an “amalgamated” implant). The implant is then released from the mold for implanted at the cartilage defect [0053]-[0054]. The implant taught at [0051]-[0054] would be reasonably expected to retain its shape after implantation, especially as Yao teaches that the implants of the disclosure retain shape after formation [0037].
Claims 4-5 are anticipated because the graft is hydrated in storage medium [0054]. While Yao does not explicitly disclose the graft is capable of storage for a period of time, such as at least about 72 hours, a chemical composition and its properties are inseparable. MPEP 2112.01 II. Therefore, because the prior art teaches a graft with the same components (cartilage pieces in storage medium), the properties the applicant discloses and/or claims (capable of storage for at least about 72 hours) are reasonably expected to be necessarily present especially as Yao teaches that use of tissue-engineered scaffold for forming the implant may be especially well-suited for applications where it is anticipated that the implant will remain in storage for a period of time [0032].
Claims 6-7 are anticipated because while Yao does not explicitly disclose that the graft is capable of being reshaped to a subsequently selected three-dimensional shape by manual manipulation and retained at that shape after reshaping, a chemical composition and its properties are inseparable. MPEP 2112.01 II. Therefore, because the prior art (Yao) teaches a graft with the same components (i.e., cartilage pieces), the properties the applicant discloses and/or claims (capable of being reshaped and then maintaining that shape at a treatment site) are reasonably expected to be necessarily present.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 4-5 and 8 are rejected under 35 U.S.C. 103 as being as being obvious over Nasert et al (US 2021/0213166 A1).
The 35 U.S.C. 102 rejection of claims 2-3 and 6-7 over Nasert was previously discussed.
Regarding claims 4-5, Nasert does not disclose at claim 9 that the cartilage graft is lyophilized and capable of storage at room temperature for a period of time, wherein the period of time is at least about 72 hours.
However, Nasert does disclose that the cartilage-derived implants may be provided in lyophilized form [0091] [0101]. Nasert teaches that lyophilization dehydrates the tissues for storage [0207].
The ordinarily skilled artisan would have been motivated to lyophilize the cartilage implant taught at claim 9 to dehydrate the tissue for storage [0207]. The lyophilized implant would be reasonably expected to be capable of storage at room temperature for a time of at least about 72 hours.
Regarding claim 8, Nasert discloses that the cartilage fibers and a plurality of cartilage particles are combined together with carriers and biologically compatible materials (claim 9).
Nasert does not disclose at claim 9 that the carrier and biologically compatible materials include each of the components required by the instant claim 8 including one or more types of cells.
However, Nasert discloses that the implants may include biologically active substances [Fig 2] [0060], additives (claim 9) [0060], binders (e.g., fibrin glue [0060]), carriers (claim 9), solvents (e.g., “aqueous buffer” [0060]), non-cartilaginous materials (“biologically-compatible material other than cartilage” [0010] [0060]), tissue derived matrices (claim 9; [0060]), scaffolds (“the cartilage fibers serve as a scaffold” [0058]), mechanically supportive components (“the cartilage fibers serve as a scaffold” [0058] which are supportive [0220]; polymers [0096]), and cells [0060].
It is prima facie obvious to combine prior art elements according to known methods, to yield predictable results. In the instant case, all the claimed elements (e.g., biologically active substances, additives, binders, carriers, solvents, non-cartilaginous materials, tissue derived matrices, scaffolds, mechanically supportive components, cells) were known in the prior art (e.g., Nasert) and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielding nothing more than predictable results (e.g., a graft) to one of ordinary skill in the art. MPEP 2143.A.
Claims 9 and 10 are rejected under 35 U.S.C. 103 as being as being obvious over Nasert et al (US 2021/0213166 A1) in view of Yao et al. (US 2009/0012629 A1).
The 35 U.S.C. 103 rejection over Nasert was previously discussed.
Additionally, Nasert discloses that the compositions of the disclosure are for repairing tissue defects and can be in the form of a sheet [0002] [0093].
Regarding claim 9, Nasert does not disclose that the implant includes one or more cartilage layers each comprising cartilage and one or more non-cartilage layers each comprising at least one binder.
Yao discloses an implant for repairing tissue defects, such as cartilage tissue defects, where the implant includes a first layer including one or more tissue particles (such as cartilage tissue particles [0016]) and a second layer comprising a biocompatible carrier (such as the biocompatible glue, fibrin [0035]) [abstract] [0013] [0036] [0051]-[0054]. Yao teaches that the biocompatible glue is used to affix an implant to a tissue defect [0038].
Since Nasert generally teaches an implant for repairing tissue defects with cartilage particles, it would have been prima facie obvious to one of ordinary skill in the art to use a cartilage layer and a binder layer, within the teachings of Nasert, because Yao teaches an implant for repairing tissue defects with a first layer with cartilage particles and a second layer with binder. An ordinarily skilled artisan would be motivated to use this form of the implant because Yao teaches that this form with a binder layer allows for the implant to be affixed to a tissue defect [0038].
Regarding claim 10, Nasert further discloses that the implant may be formed using a mold of a desired shape, where the cartilage pieces are poured into the mold (i.e., cartilage pieces deposited on a scaffold) [0093] [claim 16].
Nasert does not disclose that the mold is a non-cartilage scaffold comprising a polymer.
Yao teaches at [0012] that polymers are substrates to be used for a mold to form an implant. Yao teaches that when a polymer, such as pliable plastic, is used for the mold a medical caregiver can manually or otherwise mechanically using surgical instruments press the plastic on to the defect, such that the plastic is substantially juxtaposed to contours of the defect [0029].
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. In the instant case, since Nasert generally taught a mold to form the implant, it is prima facie obvious to select polymers for incorporation into the mold based on their recognized suitability for the intended use as a mold material, as taught by Yao.
Furthermore, an ordinarily skilled artisan would be motived to use a polymer as the mold material because Yao teaches that when a polymer, such as pliable plastic, is used for the mold a medical caregiver can manually or otherwise mechanically using surgical instruments press the plastic on to the defect, such that the plastic is substantially juxtaposed to contours of the defect [0029].
Claim 11 is rejected under 35 U.S.C. 103 as being as being obvious over Nasert et al (US 2021/0213166 A1) in view of Yao et al. (US 2009/0012629 A1) and further in view of Gong et al. (Biomaterials,2011, 32:2265-2273).
The 35 U.S.C. 103 rejection over Nasert in view of Yao was previously discussed.
Regarding claim 11, the combined teachings of Nasert and Yao do not disclose a plurality of cartilage layers wherein the cartilage layers alternate between the non-cartilage layers.
Gong discloses an extracellular matrix for cartilage engineering with a plurality of cartilage layers (cartilage sheets) and non-cartilage layers which alternate with the cartilage layers (abstract; pg. 2266, Fig 1). Gong teaches that the multiple alternative layers (“sandwich model”) allows for recipient cells to be evenly seeded and distributed in the construct to effectively engineer cartilage (pg. 2266, left column; pg. 2271-2272).
Since the combined teachings of the prior art generally teaches cartilage for tissue engineering, it would have been prima facie obvious to one of ordinary skill in the art to include a plurality of cartilage layers wherein the cartilage layers alternate between the non-cartilage layers, within the combined teachings of the prior art, because Gong teaches an extracellular matrix for cartilage engineering with a plurality of cartilage layers (cartilage sheets) and non-cartilage layers which alternate with the cartilage layers. An ordinarily skilled artisan would be motivated to use this “sandwich model” taught by Gong because Gong teaches that the multiple alternative layers allows for recipient cells to be evenly seeded and distributed in the construct effectively engineering cartilage (pg. 2266, left column; pg. 2271-2272).
Claims 8-10 are rejected under 35 U.S.C. 103 as being as being obvious over Yao et al. (US 2009/0012629 A1).
The 35 U.S.C. 102 rejection of claims 2-7 over Yao was previously discussed.
Regarding claim 8, Yao does not disclose at [0051]-[0054] that the graft further comprises each of the components required by claim 8 including one or more types of cells.
However, Yao teaches that that graft can include biologically active substances [0054] [0012]-[0013], additives [0054] [0041], binders (i.e., fibrin) [0054] [0035], carriers [0054] [0035] [0044], solvents [0054] [0047], non-cartilaginous materials [0054] [0041], tissue derived matrices [0054] [0032], scaffolds [0054] [0032], mechanically supportive components [0054] [0032], and cells [0041].
It is prima facie obvious to combine prior art elements according to known methods, to yield predictable results. In the instant case, all the claimed elements (e.g., biologically active substances, additives, binders, carriers, solvents, non-cartilaginous materials, tissue derived matrices, scaffolds, mechanically supportive components, cells) were known in the prior art (e.g., Yao) and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielding nothing more than predictable results (e.g., a graft) to one of ordinary skill in the art. MPEP 2143.A.
Claim 9 is rendered prima facie obvious because Yao discloses cartilage tissue fragments are transferred to the mold (forming a layer across the surface of the base of the mold) and a layer of fibrin (a binder) is added on top of the cartilage tissue fragments. [0053]-[0054].
Regarding claim 10, Yao discloses at [0051]-[0054] that a cartilage layer comprising a coating of amalgamated cartilage pieces is deposited on a non-cartilage scaffold (aluminum foil, [0052]).
Yao does not disclose at [0051]-[0054] that the scaffold comprises a polymer.
However, Yao does disclose at [0012] that both aluminum foil and polymers are substrates having shape memory to be used for the mold. Yao teaches that when a polymer is used for the mold a medical caregiver can manually or otherwise mechanically using surgical instruments press the plastic on to the defect, such that the plastic is substantially juxtaposed to contours of the defect [0029].
Generally, it is prima facie obvious to substitute equivalents known for the same purpose. See MPEP 2144.06. In the instant case, since Yao taught both aluminum foil and polymers as suitable mold materials, it is prima facie obvious to select polymers as a mold material, as taught by Yao [0012].
Furthermore, an ordinarily skilled artisan would be motived to use a polymer as the mold material because Yao teaches that when a polymer is used for the mold a medical caregiver can manually or otherwise mechanically using surgical instruments press the plastic on to the defect, such that the plastic is substantially juxtaposed to contours of the defect [0029].
Claim 11 is rejected under 35 U.S.C. 103 as being as being obvious over Yao et al. (US 2009/0012629 A1) in view of Gong et al. (Biomaterials,2011, 32:2265-2273).
The 35 U.S.C. 103 rejection over Yao was previously discussed.
Regarding claim 11, Yao discloses a first layer and a second layer, where the first layer comprises one or more tissue particles (such as cartilage tissue particles [0016] [0051]-[0054]) and the second layer includes at least one biocompatible carrier (such as fibrin glue [0016] [0035]) [0018]. The second layer may further include a bioactive agent, such as chondrocytes [0017]-[0018].
Yao does not disclose a plurality of cartilage layers wherein the cartilage layers alternate between the non-cartilage layers.
Gong discloses an extracellular matrix for cartilage engineering with a plurality of cartilage layers (cartilage sheets) and non-cartilage layers (of chondrocytes) which alternate with the cartilage layers (abstract; pg. 2266, Fig 1). Gong teaches that the multiple alternative layers (“sandwich model”) allows for recipient cells to be evenly seeded and distributed in the construct to effectively engineer cartilage (pg. 2266, left column; pg. 2271-2272).
Since Yao generally teaches cartilage for tissue engineering, it would have been prima facie obvious to one of ordinary skill in the art to include a plurality of cartilage layers wherein the cartilage layers alternate between the non-cartilage layers, within the teachings of Yao, because Gong teaches an extracellular matrix for cartilage engineering with a plurality of cartilage layers (cartilage sheets) and non-cartilage layers which alternate with the cartilage layers. An ordinarily skilled artisan would be motivated to use this “sandwich model” taught by Gong because Gong teaches that the multiple alternative layers allows for recipient cells to be evenly seeded and distributed in the construct to effectively engineer cartilage (pg. 2266, left column; pg. 2271-2272).
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 2-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,938,245 in view of Nasert et al (US 2021/0213166 A1), Yao et al. (US 2009/0012629 A1), and Gong et al. (Biomaterials,2011, 32:2265-2273).
Claims 2-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,806,443 in view of Nasert et al (US 2021/0213166 A1), Yao et al. (US 2009/0012629 A1), and Gong et al. (Biomaterials,2011, 32:2265-2273).
Claims 2-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 11,052,175 in view of Nasert et al (US 2021/0213166 A1), Yao et al. (US 2009/0012629 A1), and Gong et al. (Biomaterials,2011, 32:2265-2273).
Although the claims at issue are not identical, they are not patentably distinct from each other. The claims recite all of the features instantly recited for the composition except for the graft being lyophilized, each of the components required by the instant claim 8 including one or more types of cells, that the implant includes one or more cartilage layers each comprising cartilage and one or more non-cartilage layers each comprising at least one binder, that the scaffold comprises a polymer, or that there are plurality of cartilage layers wherein the cartilage layers alternate between the non-cartilage layers.
Nasert discloses cartilage implants which are in lyophilized form [0091] [0101]. Nasert teaches that lyophilization dehydrates the tissues for storage [0207]. Nasert also discloses that the implants may include biologically active substances [Fig 2] [0060], binders (e.g., fibrin glue [0060]), solvents (e.g., “aqueous buffer” [0060]), non-cartilaginous materials (“biologically-compatible material other than cartilage” [0010] [0060]), tissue derived matrices (claim 9; [0060]), scaffolds (“the cartilage fibers serve as a scaffold” [0058]), mechanically supportive components (“the cartilage fibers serve as a scaffold” [0058] which are supportive [0220]; polymers [0096]), and cells [0060].
Yao discloses an implant for repairing tissue defects, such as cartilage tissue defects, where the implant including a first layer including one or more tissue particles (such as cartilage tissue particles [0016]) and a second layer comprising a biocompatible carrier (such as biocompatible glue; fibrin [0035]) [abstract] [0013] [0036] [0051]-[0054]. Yao teaches that the biocompatible glue is used to affix an implant to a tissue defect [0038]. Yao discloses at [0012] that polymers are substrates having shape memory to be used for the mold. Yao teaches that when a polymer, such as pliable plastic, is used for the mold a medical caregiver can manually or otherwise mechanically using surgical instruments press the plastic on to the defect, such that the plastic is substantially juxtaposed to contours of the defect [0029].
Gong discloses cartilage as an extracellular matrix for cartilage engineering with a plurality of cartilage layers (cartilage sheets) and non-cartilage layers which alternate with the cartilage layers (abstract; pg. 2266, Fig 1). Gong teaches that the multiple alternative layers (“sandwich model”) allows for recipient cells to be evenly seeded and distributed in the construct effectively engineering cartilage (pg. 2266, left column; pg. 2271-2272).
The ordinarily skilled artisan would have been motivated to lyophilize the graft to dehydrate the tissue for storage and include the components as recited in claim 8 to formulate the graft as taught by Nasart [0207] [Fig 2] [0060] [0010] [0058] [0220] [0096]. The skilled artisan would have been motivated to include a non-cartilage layer including a binder to affix an implant to a tissue defect [0038] and to include a scaffold comprises a polymer as a mold material so that a medical caregiver can manually or otherwise mechanically using surgical instruments press the plastic on to the defect, such that the plastic is substantially juxtaposed to contours of the defect [0029] as taught by Yao. The skilled artisan would also have been motivated to include a plurality of cartilage layers wherein the cartilage layers alternate between the non-cartilage layers to allow for recipient cells to be evenly seeded and distributed in the construct effectively engineering cartilage as taught by Gong (pg. 2266, left column; pg. 2271-2272).
Claims 2-11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Patent Application No. 18/591,564 in view of Nasert et al (US 2021/0213166 A1), Yao et al. (US 2009/0012629 A1), and Gong et al. (Biomaterials,2011, 32:2265-2273).
Although the claims at issue are not identical, they are not patentably distinct from each other. The copending claims recite all of the features instantly recited for the composition except for the graft being lyophilized, each of the components required by the instant claim 8 including one or more types of cells, that the implant includes one or more cartilage layers each comprising cartilage and one or more non-cartilage layers each comprising at least one binder, that the scaffold comprises a polymer, or that there are plurality of cartilage layers wherein the cartilage layers alternate between the non-cartilage layers.
Nasert discloses cartilage implants which are in lyophilized form [0091] [0101]. Nasert teaches that lyophilization dehydrates the tissues for storage [0207]. Nasert also discloses that the implants may include biologically active substances [Fig 2] [0060], binders (e.g., fibrin glue [0060]), solvents (e.g., “aqueous buffer” [0060]), non-cartilaginous materials (“biologically-compatible material other than cartilage” [0010] [0060]), tissue derived matrices (claim 9; [0060]), scaffolds (“the cartilage fibers serve as a scaffold” [0058]), mechanically supportive components (“the cartilage fibers serve as a scaffold” [0058] which are supportive [0220]; polymers [0096]), and cells [0060].
Yao discloses an implant for repairing tissue defects, such as cartilage tissue defects, where the implant including a first layer including one or more tissue particles (such as cartilage tissue particles [0016]) and a second layer comprising a biocompatible carrier (such as biocompatible glue; fibrin [0035]) [abstract] [0013] [0036] [0051]-[0054]. Yao teaches that the biocompatible glue is used to affix an implant to a tissue defect [0038]. Yao discloses at [0012] that polymers are substrates having shape memory to be used for the mold. Yao teaches that when a polymer is used for the mold a medical caregiver can manually or otherwise mechanically using surgical instruments press the plastic on to the defect, such that the plastic is substantially juxtaposed to contours of the defect [0029].
Gong discloses cartilage as an extracellular matrix for cartilage engineering with a plurality of cartilage layers (cartilage sheets) and non-cartilage layers which alternate with the cartilage layers (abstract; pg. 2266, Fig 1). Gong teaches that the multiple alternative layers (“sandwich model”) allows for recipient cells to be evenly seeded and distributed in the construct effectively engineering cartilage (pg. 2266, left column; pg. 2271-2272).
The ordinarily skilled artisan would have been motivated to lyophilize the graft to dehydrate the tissue for storage and include the components as recited in claim 8 to formulate the graft as taught by Nasart [0207] [Fig 2] [0060] [0010] [0058] [0220] [0096]. The skilled artisan would have been motivated to include a non-cartilage layer including a binder to affix an implant to a tissue defect [0038] and to include a scaffold comprises a polymer as a mold material so that a medical caregiver can manually or otherwise mechanically using surgical instruments press the plastic on to the defect, such that the plastic is substantially juxtaposed to contours of the defect [0029] as taught by Yao. The skilled artisan would also have been motivated to include a plurality of cartilage layers wherein the cartilage layers alternate between the non-cartilage layers to allow for recipient cells to be evenly seeded and distributed in the construct effectively engineering cartilage as taught by Gong (pg. 2266, left column; pg. 2271-2272).
This is a provisional nonstatutory patenting rejection.
Conclusion
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/ASHLEE E WERTZ/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
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