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 .
Response to Arguments
Applicant’s arguments, see page 2 of remarks (pg 8 of response), filed 4/10/26, with respect to the rejection(s) of claim(s) 6,21-24 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of teachings of Maxson et al. (8475531). In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Thus, Yoo is a teaching that can be combined because it was just for that concept of having 3 layers with aligned pores, it was not use particularly for materials of the layers, or its use as argued, thus the argument is moot. If it was suggesting the same Yoo would anticipate the claim.
With respect to the arguments against the combination of teachings with Teoh, it is noted the amendment necessitated the change of teachings, particularly the use of Maxson in place of Teoh to address the change in scope or required limitation. In addition the argument focusing on alleged differences in methods of manufacture, is a moot or immaterial issue when the claims are to a product and methods of producing a material is an improper comparison of claim scope.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 6,21-24,34 are rejected under 35 U.S.C. 103 as being unpatentable over (CN 108525012 cited in IDS of 5/15/23) in view of Yoo et al. (WO 2014/011891) and in view of Maxson et al. (8475531). CN '012 disclose to provide an osteochondral scaffold, comprising (page 2, step 1 of method) a cartilage layer, an adhesive layer (cartilage integration layer) and a bone layer, the adhesive (calcification layer fixes two surrounding layers together 4th paragraph page 1) layer being connected to the cartilage layer and the bone layer on each side; the cartilage layer, the adhesive layer and the bone layer being porous; the pores of the cartilage layer, the pores of the adhesive layer and the pores of the bone layer are communicated, see step 7 of method, page 2. CN '012 disclose (page 2 bottom of page discuss preparation of cartilage layer such that the material of the cartilage laver is a hydrogel material. Please note that sol-gels can be a form of a hydrogel and the recited layers being a hydrogel is broad and non-limited to a specific chemical compound but a large category of materials that can be gelatinous in form. It is noted that CN '012 discloses (page 2) the pores of the cartilage layer, the pores of the adhesive layer and the pores of the bone layer are interpenetrating which could be construed as completely or incompletely aligned; the adhesive layer does not cover or partially covers the pores of the bone layer and the cartilage. CN '012 did not explicitly state the pores are completely aligned and the adhesive layer does not cover the pores of the bone or cartilage layers. Yoo et al. teach a cartilage repair device that has three layers with pores of all layers aligned such that the middle connecting layer does not cover the outer two layers' sets of pores. It would have been obvious to one of ordinary skill in the art to provide the pores through the layers to be completely aligned as taught by Yoo et al. in the cartilage osteochondral scaffold of CN '012 such that it provides a flow path for cells and factors to migrate therethrough, see Yoo et al. (page 11, paragraphs 68,69). However, CN '012 also did not explicitly disclose the material of the bone layer is polylactic acid, polylactic-co-glycolic acid or polycaprolactone and the adhesive is a medical glue. Maxson et al. teach (col. 5, lines 61,64col. 6, lines 7-22) that a material for the bone layer of an osteochondral scaffold is made from polycaprolactone or polylactic acid. It would have been obvious to one of ordinary skill in the art to utilize polycaprolactone or polylactic acid as the bone layer as taught by Maxson et al. with the osteochondral scaffold of CN '012 and modified with Yoo et al. in order to provide a suitable scaffold that allows bone cells to attach and proliferate, (see col. 5, lines 49,50 of Maxson et al.). It is also noted that Maxson et al. teach (col. 13, lines 24-27) an adhesive to join the bone and cartilage layers which can be construed to be a medical glue. It would have been obvious to one of ordinary skill in the art to select an appropriate adhesive such as a medical glue as taught by Maxson et al. with the osteochondral scaffold of CN ‘012 and Yoo in order to effectively bond the layers together. With respect to claim 21, CN '012 disclose (1st paragraph of page 4) the height ratio of the bone layer and the cartilage layer can have values that fall within the range of 1:(0.1-1). Regarding claim 22, CN '012 disclose (see pages 5,6) that the porosity of the osteochondral scaffold is a value that falls within the range of 20%-70%. It would be inherent that if a porous scaffold has completely aligned pores for the layers and the adhesive layer does not cover the pores of the cartilage layer and the bone layer, then the porosity inherently provides the same value throughout and the porosity of the cartilage layer and the bone layer is 20-70%. With respect to claim 23, CN '012 discloses (page 4) the pore diameter of the pores of the bone layer is equal to that of the pores of the cartilage layer. Regarding claim 24, CN '012 disclose (page 4) the osteochondral scaffold can be a cylinder. CN '012 further disclose (page 4) the cylinder has a diameter that falls in the range of 2-20 mm, the cylinder has a height that falls within the range of 2-10 mm, the height of the adhesive (cartilage calcification) layer is a value that falls within the range of 5 µm to 2 mm. With respect to the limitation of " preparation method for the cartilage layer is a 3D printing demolding method comprising the following steps: S1, carrying out 3D printing with a sacrificial material to obtain a cartilage layer mold; wherein the sacrificial material is a hard high polymer material which can be dissolved in a solvent; S2, pouring the hydrogel composition of the cartilage layer into the cartilage layer mold for crosslinking to obtain a cured hydrogel-cartilage layer mold complex; S3, demolding: dissolving the cartilage layer mold with a solvent to obtain a cured hydrogel; S4, freeze-drying the obtained cured hydrogel to obtain the cartilage layer; the preparation method for the bone layer is 3D printing with the material of the bone layer; the 3D printing is carried out using a fused deposition 3D printer" is to be considered a product-by- process limitation and even 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, 227 USPQ 964,966). Once the Examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by & different process, the burden shifts to applicant to come forward with evidence establishing an unobvious different between the claimed product and the prior art product (/n re Marosi, 710 F.2d 798, B02, 218 USPO 289, 292 (Fed. Cir, 1953}, MPEP 2113). Thus absent any distinguishing features it cannot be said the method of making is providing any different hydrogel particularly disclosed by CN ‘012.
Claim(s) 7 is rejected under 35 U.S.C. 103 as being unpatentable over (CN 108525012 in view of Yoo et al. (WO 2014/011891) and in view of Maxson et al. (8475531) as applied to claim 6 above, and further in view of Cordaro (10117746). CN '012 modified with Yoo et al. and in view of Maxson et al. is explained supra. However, CN '012 in view of Yoo et al. and in view of Maxson et al. did not teach the distribution of the pores of the cartilage layer and the bone layer is arranged vertically and crosswise. Cordaro teaches (Fig. 15) an osteochondral scaffold is constructed with the distribution of the pores being arranged vertically and crosswise. It would have been obvious to one of ordinary skill in the art to provide an osteochondral scaffold with pores distributed in an arrangement vertically and crosswise as taught by Cordaro in the osteochondral scaffold of CN '012 as alternatively modified by Yoo et al. and in view of Maxson et al. such that it provides multiple pathways for cell integration, see claim 1 of Cordaro.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Bradica et al. (10016278) disclose (col. 11, lines 24,25) an osteochondral scaffold, made of layers, see Fig. 13 or 14a. Bradica et al. also disclose a cartilage layer, col. 21, lines 38-40 with the material of the cartilage layer being a hydrogel material. Bradica et al. also disclose (col. 10, lines 26-29) an adhesive layer connects the cartilage layer to a bone layer..
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN E PELLEGRINO whose telephone number is (571)272-4756. The examiner can normally be reached 8:30am-5:00pm M-F.
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/BRIAN E PELLEGRINO/Primary Examiner, Art Unit 3799
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