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
This application is a National Stage entry of PCT/CN2022/072584, filed 01/18/2022. This application claims foreign priority to CN202110077195.X, filed 01/20/2021.
Information Disclosure Statement
The IDS filed on 7/20/2023 and 6/13/2024 have been considered. See the attached PTO 1449 form.
Election/Restrictions
Applicant's election with traverse of Group I (claims 1-6) in the reply filed on 2/23/2026 is acknowledged. The traversal is on the ground(s) that the claimed gel cartilage is obtained by chondrocytes subjected to in vitro gelation culture for about 3 days, chondrocytes having a density of 1x10^8 cell/ml or 1x10^8 cells/g and the adhesion rate of the gel cartilage is >90%. Applicant appear to argue that the process taught by Yanaga et al. is different from the present application and results in a different product. This is not found persuasive because as discussed in the restriction requirement and the 103 rejection below, while the method taught by Yanaga may not be the same method recited in the instant claims, the product disclosed by Yanage, and the secondary references cited below, render obvious a product which is structurally the same as the product recited in the claims. "[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). See MPEP 2113 (I).
The requirement is still deemed proper and is therefore made FINAL.
Claims 7-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 Status
Receipt of Remarks filed on 2/23/2026 is acknowledged. Claims 1-17 are currently pending. Claims 7-17 have been withdrawn. Accordingly, claims 1-6 are currently under examination.
Claim Objections
Claim 2 is objected to because of the following informalities:
In claim 2, line 2, “DMEM” should not be abbreviated and should be spelled entirely the
first time it is used in the claims.
In claim 2, line 2, “FBS” should not be abbreviated and should be spelled entirely the
first time it is used in the claims.
Appropriate correction is required.
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.
Claims 2 and 4 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 2 recites “100 U/ml penicillin-streptomycin”. It is unclear whether the concentration of 100 U/ml means that there is 100 U/ml of penicillin and 100 U/ml of streptomycin, or whether the combined concentration/amount of penicillin and streptomycin equals 100 U/ml. Thus, the recitation “100 U/ml penicillin-streptomycin” in the claim makes it unclear as to what is the concentration/amount of each of penicillin and streptomycin.
Claim 4 recites “the concentration of chondrocytes in the gel cartilage is 1.0 x 108 cells/ml-10 x 108 cells/ml, preferably 1.5-5 x 108 cells/ml”. There is insufficient antecedent basis for the limitation “the concentration of chondrocytes” in the claim because claim 1 recites a density of chondrocytes but no concentration is recited in claim 1. It is unclear whether the concentration in claim 4 is referring to the density and further limiting the density of the chondrocytes or whether the concentration of chondrocytes recited in claim 4 is different from the density recited in claim 1. The concentration of 1.0 x 108 cells/ml recited in claim 4 is the same as the density recited in claim 1 which makes it unclear whether the concentration is referring to the density and further limiting it in claim 4 or whether the concentration recited in claim 4 is different from the density that is recited in claim 1.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 4 recites the broad recitation “1.0 x 108 cells/ml-10 x 108 cells/ml”, and the claim also recites “preferably 1.5-5 x 108 cells/ml” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over Yanaga et al. (US7704495B2) in view of Masuda (US20030229400A1) and Gomes (US20040230303A1).
Yanaga throughout the reference teaches process for producing cartilage cells for transplantation in humans.
Yanaga teaches cartilage therapy material comprising chondrocytes. Particularly, Yanaga teaches a gel-like chondrocyte mass which can be obtained by monolayer or multilayer seeding and culturing the subcultured human chondrocytes once or more, preferably 3 to 4 times. In the chondrocyte mass thus obtained, the chondrocytes cells are surrounded by a cartilage matrix (extra cellular matrix) containing aggrecan, etc. and the cells are bonded to each other via the matrix such as aggrecan to form a gel-like cell mass. Subculture was carried out by seeding 1×106 of the primary-cultured cells. The chondrocytes obtained by the subculture were seeded by overlaying thrice at a density of 1×106cells/cm2. Yanaga teaches to culture chondrocytes, use can be made of publicly known media suitable for culturing chondrocytes. As an example of such a medium, DME(H) medium containing FBS (preferably 10%). The culture is continued until the proliferated cells form a confluent monolayer. (see: Examples 1 and 2; Section: A. Human Chondrocytes; Claims; Abstract; Col. 2, Col. 4-5; Entire document).
The teachings of Yanaga have been set forth above.
As discussed supra, Yanaga teaches the chondrocytes obtained by the subculture were seeded by overlaying thrice at a density of 1×106cells/cm2. Yanaga does not expressly teach wherein the density of chondrocytes is at least 1.0 x 108 cells/ml or 1.0 x 108 cells/g and wherein the concentration of chondrocytes in the gel cartilage is 1.0 x 108 cells/ml-10 x 108 cells/ml, preferably 1.5-5 x 108 cells/ml. Further, Yanaga does not teach wherein the adhesion rate of the gel cartilage is > 90% or >95%. Yanaga also does not teach wherein the chondrocytes are selected from elastic cartilage, fibrocartilage, or hyaline cartilage. Gomes and Masuda cure these deficiencies.
Gomes is also directed to cartilage repair art and teaches cartilage matrix wherein cells are inserted into the matrix. Gomes teaches cells include allogenic or autologous, bone marrow cells, stem cells and chondrocyte cells. The cellular density of the cells preferably ranges from 1.0 X I0⁸ to 5.0 X 10⁸ or from about 100 million to about 500 million cells per CC of putty or gel mixture. Gomes in the background of its disclosure teaches that there have been problems with adhesion and stability of the grafts, which result in their displacement or loss from the repair site. (e.g. Abstract; claims 1-48; Figures 1-9 and accompanying text; para 0009; 0056).
Masuda is also directed to osteochondral implant comprising engineered cartilage tissue wherein the cartilage tissue is derived from chondrogenic cells (differentiated chondrocytes) cultured in vitro, the cells having a cell associated matrix (CM). Masuda teaches cells with a reestablished CM are further cultured in medium on biocompatible support scaffold for a length of time effective for allowing formation of a cohesive cartilage matrix. An effective time of culture is typically at least about 3 days under standard culture conditions. Partial inhibition of matrix maturation prior to implantation can provide a matrix that is not as stiff as a mature cartilage, and which has a tensile strength sufficient to retain its shape and structure during handling. The chondrogenic cells (differentiated chondrocytes) can be isolated directly from pre-existing cartilage tissue, for example, hyaline cartilage, elastic cartilage, or fibrocartilage. (see e.g. abstract; claims; para 0064).
It would have been prima facie obvious to one or ordinary skill in the art to have combined the teaching of Yanaga, Gomes and Masuda and have the density of Yanaga’s gel like cartilage cells to be from 1.0 X I0⁸ to 5.0 X 10⁸ or from about 100 million to about 500 million cells per CC of gel mixture as taught by Gomes. As discussed supra, Yanaga teaches the chondrocytes obtained by the subculture were seeded by overlaying thrice at a density of 1×106cells/cm2. Yanaga does not expressly teach a density which is at least 1 x 10^8 cells/ml or a concentration which is at least 1 x 10^8 cells/ml. However, as mentioned above, Gomes is also directed to cartilage repair art and teaches cartilage matrix wherein cells are inserted into the matrix. Gomes teaches cells include allogenic or autologous, bone marrow cells, stem cells and chondrocyte cells. The cellular density of the cells preferably ranges from 1.0 X I0⁸ to 5.0 X 10⁸ or from about 100 million to about 500 million cells per CC of putty or gel mixture. It would have been obvious to one skilled in the art to have the density and concentration of the chondrocyte cells in the cartilage gel which was known in the art such as the density/concentration disclosed by Gomes. Further, the density/concentration of chondrocytes can be adjusted by routine experimentation based on the need for osteogenic effects and physical properties of the gel desired. “The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.” In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969). See MPEP 2144.05. 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).
It would have been prima facie obvious to one or ordinary skill in the art to have combined the teaching of Yanaga, Gomes and Masuda and have the adhesion rate of the cartilage gel to be more than 95%. As discussed supra, Masuda is also directed to osteochondral implant comprising engineered cartilage tissue wherein the cartilage tissue is derived from chondrogenic cells (differentiated chondrocytes) cultured in vitro, the cells having a cell associated matrix (CM). Masuda teaches cells with a reestablished CM are further cultured in medium on biocompatible support scaffold for a length of time effective for allowing formation of a cohesive cartilage matrix. An effective time of culture is typically at least about 3 days under standard culture conditions. Partial inhibition of matrix maturation prior to implantation can provide a matrix that is not as stiff as a mature cartilage, and which has a tensile strength sufficient to retain its shape and structure during handling. Further, as mentioned above, Gomes in the background of its disclosure teaches that there have been problems with adhesion and stability of the grafts, which result in their displacement or loss from the repair site. The combination of the references suggests that the transplant cartilage material should have high adhesion/cohesiveness so it is not displaced from the repair site and as discussed supra, Masuda teaches that cell associated matrix can be cultured in medium for a length of time effective for allowing formation of a cohesive cartilage matrix. Thus, one skilled in the art would have found it obvious to culture the cell associated matrix / cartilage matrix for an amount of time which provides 100% adhesion/cohesiveness as the art suggests the cartilage matrix such as the one claimed should have high adhesion / cohesiveness so it does not get displaced.
It would have been prima facie obvious to one or ordinary skill in the art to have combined the teaching of Yanaga, Gomes and Masuda and include chondrocytes which are selected from elastic, cartilage, fibrocartilage or hyaline cartilage in Yanaga’s product. Yanaga does not specify the particular chondrocytes which are used to make the cartilage cells, however, Masuda teaches the chondrogenic cells (differentiated chondrocytes) can be isolated directly from pre-existing cartilage tissue, for example, hyaline cartilage, elastic cartilage, or fibrocartilage. Thus, it would have been obvious to one of ordinary skill in the art to substitute and include the chondrocytes which are known in the art as a person with ordinary skill has good reason to pursue known options within his or her technical grasp. see MPEP 2141 KSR International CO. v. Teleflex Inc. 82 USPQ 2d 1385 (Supreme Court 2007).
Regarding the claimed limitations wherein the gel cartilage is obtained by gelation culture for 2-5 days (or 2.5-4 days) and wherein the gelation medium for gelation culture is DMEM medium containing 4-5 wt% glucose, 10% FBS (v/v) and 100 U/ml penicillin- streptomycin, these limitations are directed to method steps of making the product which a gel cartilage. The claims are directed to a product and, as discussed supra, the combination of the cited references render obvious all the components/structure of the product and the method steps do not add any structural limitation to the product itself. "[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). See MPEP 2113 (I).
From the combined teaching of the cited reference, 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.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-6 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of copending Application No. 18/262,224 (US20240091411A1) in view of Masuda (US20030229400A1).
‘224 claims also recite a cartilage gel comprising a cell population of chondrocytes and extracellular matrix secreted by chondrocytes, wherein the extracellular matrix encapsulates the cell population, and the ear cartilage gel is in a gel state and the density of chondrocytes is at least 1 x 10^8 cells/ml. The cartilage gel is obtained by gelation culture for 3-5 days. The adhesion rate of cartilage gel is >95%. The gelation medium containing high glucose DMEM medium containing 4-5% glucose, 10% FBS and 100 U/ml penicillin-streptomycin.
‘224 does not teach wherein the chondrocytes are selected from elastic cartilage, fibrocartilage, or hyaline cartilage. However, Masuda cures this deficiency.
The teachings of Masuda discussed above are incorporated herein.
It would have been prima facie obvious to one or ordinary skill in the art to have combined the teaching of ‘224 and Masuda and include chondrocytes which are selected from elastic, cartilage, fibrocartilage or hyaline cartilage in ‘224 cartilage gel. ‘224 does not specify the particular chondrocytes which are used to make the cartilage gel, however, Masuda teaches the chondrogenic cells (differentiated chondrocytes) can be isolated directly from pre-existing cartilage tissue, for example, hyaline cartilage, elastic cartilage, or fibrocartilage. Thus, it would have been obvious to one of ordinary skill in the art to substitute and include the chondrocytes which are known in the art as a person with ordinary skill has good reason to pursue known options within his or her technical grasp. see MPEP 2141 KSR International CO. v. Teleflex Inc. 82 USPQ 2d 1385 (Supreme Court 2007).
From the combined teaching of the cited reference, 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.
Claims 1-6 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-5, 7, 9-12, 14-15 and 17-20 of copending Application No. 18/262,232 (US20240091407A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because ‘232 claims a cartilage tissue engineering complex which comprises a carrier and a cartilage gel comprising a cell population of chondrocytes and extracellular matrix secreted by chondrocytes, wherein the extracellular matrix encapsulates the cell population, and the ear cartilage gel is in a gel state and the density of chondrocytes is at least 1 x 10^8 cells/ml. The cartilage gel is obtained by gelation culture for 3-5 days. The adhesion rate of cartilage gel is >95%. The gelation medium containing high glucose DMEM medium containing 4-5% glucose, 10% FBS and 100 U/ml penicillin-streptomycin. The chondrocytes are selected from elastic cartilage, fibrocartilage, or hyaline cartilage.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-6 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of copending Application No. 18/841,534 (US20250161534A1) in view of Masuda (US20030229400A1) and and Gomes (US20040230303A1).
‘534 claims a tissue engineering cartilage particle comprising a cell population composed of chondrocytes and an extracellular matrix secreted by chondrocytes, wherein the extracellular matrix wraps around the cell population. Density of chondrocytes in a single cartilage particle is at least 10^4 to 10^5 cells per cartilage particle. ‘534 discloses concentration of chondrocyte which is 0.05 x 10^6 to 20 x 10^ cells/mL of culture medium. ‘534 also teaches culture medium containing DMEM high glucose medium, 1% triple antibiotic and 10 fetal bovine serum.
‘534 does not teach the exact density that is recited in the instant claims, the adhesion rate and wherein the chondrocytes are selected from elastic cartilage, fibrocartilage, or hyaline cartilage. However, Masuda and Gomes cure this deficiency.
The teachings of Masuda and Gomes discussed above are incorporated herein.
It would have been prima facie obvious to one or ordinary skill in the art to have combined the teaching of ‘534, Gomes and Masuda and have the density of ‘534 cartilage to be from 1.0 X I0⁸ to 5.0 X 10⁸ or from about 100 million to about 500 million cells per CC of gel mixture as taught by Gomes. As mentioned above, Gomes is also directed to cartilage repair art and teaches cartilage matrix wherein cells are inserted into the matrix. Gomes teaches cells include allogenic or autologous, bone marrow cells, stem cells and chondrocyte cells. The cellular density of the cells preferably ranges from 1.0 X I0⁸ to 5.0 X 10⁸ or from about 100 million to about 500 million cells per CC of putty or gel mixture. It would have been obvious to one skilled in the art to have the density and concentration of the chondrocyte cells which was known in the art such as the density/concentration disclosed by Gomes. Further, the density/concentration of chondrocytes can be adjusted by routine experimentation based on the need for osteogenic effects and physical properties of the gel desired. “The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.” In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969). See MPEP 2144.05.
It would have been prima facie obvious to one or ordinary skill in the art to have combined the teaching of ‘534, Gomes and Masuda and have the adhesion rate of the cartilage to be more than 95%. As discussed supra, Masuda is also directed to osteochondral implant comprising engineered cartilage tissue wherein the cartilage tissue is derived from chondrogenic cells (differentiated chondrocytes) cultured in vitro, the cells having a cell associated matrix (CM). Masuda teaches cells with a reestablished CM are further cultured in medium on biocompatible support scaffold for a length of time effective for allowing formation of a cohesive cartilage matrix. An effective time of culture is typically at least about 3 days under standard culture conditions. Partial inhibition of matrix maturation prior to implantation can provide a matrix that is not as stiff as a mature cartilage, and which has a tensile strength sufficient to retain its shape and structure during handling. Further, as mentioned above, Gomes in the background of its disclosure teaches that there have been problems with adhesion and stability of the grafts, which result in their displacement or loss from the repair site. The combination of the references suggests that the transplant cartilage material should have high adhesion/cohesiveness so it is not displaced from the repair site and as discussed supra, Masuda teaches that cell associated matrix can be cultured in medium for a length of time effective for allowing formation of a cohesive cartilage matrix. Thus, one skilled in the art would have found it obvious to culture the cell associated matrix / cartilage matrix for an amount of time which provides 100% adhesion/cohesiveness as the art suggests the cartilage matrix such as the one claimed should have high adhesion / cohesiveness so it does not get displaced.
It would have been prima facie obvious to one or ordinary skill in the art to have combined the teaching of ‘534 and Masuda and include chondrocytes which are selected from elastic, cartilage, fibrocartilage or hyaline cartilage in ‘534. ‘534 does not specify the particular chondrocytes which are used to make the cartilage, however, Masuda teaches the chondrogenic cells (differentiated chondrocytes) can be isolated directly from pre-existing cartilage tissue, for example, hyaline cartilage, elastic cartilage, or fibrocartilage. Thus, it would have been obvious to one of ordinary skill in the art to substitute and include the chondrocytes which are known in the art as a person with ordinary skill has good reason to pursue known options within his or her technical grasp. see MPEP 2141 KSR International CO. v. Teleflex Inc. 82 USPQ 2d 1385 (Supreme Court 2007).
From the combined teaching of the cited reference, 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.
Conclusion
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