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 .
Election/Restrictions
Applicant's election with traverse of grouping of different inventions for lacking unity in the reply filed on 10/17/25 is acknowledged. The traversal is on the ground(s) that these groups all have unity since they are directed to a product, a process adapted to manufacture the said product and use of the said product. This is not found persuasive because the prior art showed the layered structure as recited. Further Applicant amended the claim to include features not previously required in all groups before to now change the scope of the claims. Additionally, the proposed new Group III for claim 12 per the amendment does not establish any particular use as there is no method step in the claim. Also, the method of making claim (8) could be interpreted to have different materials not required by claim 6 and thus lack unity. For example claim 8 could be interpreted that the bone layer is bone material and the cartilage layer is cartilage material, thus different than the recited materials as presented in amended claim 6. The requirement is still deemed proper and is therefore made FINAL.
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.
Claim(s) 6,21-24 are rejected under 35 U.S.C. 103 as being unpatentable over (CN 108525012 cited in IDS of 5/15/23) alternatively in view of Yoo et al. (WO 2014/011891) and in view of Teoh et al. (2007/0083268). 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. CN ‘012 further disclose (page 3 discussion of preparing the cartilage calcification layer) the adhesive laver is formed of 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. Alternatively 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 did not explicitly disclose the material of the bone layer is polylactic acid, polylactic-co-glycolic acid or polycaprolactone. Teoh et al. teach that a layered material for bone tissue regeneration is made from polycaprolactone. It would have been obvious to one of ordinary skill in the art to utilize polycaprolactone as the bone layer as taught by Teoh et al. with the osteochondral scaffold of CN ‘012 alternatively modified with Yoo et al. in order to provide a suitable scaffold that allows bone cells to attach and proliferate, (see paragraph 84 of Teoh et al.). 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) and also Teoh et al. teach the same for values to provide a ratio in the claimed range (paragraph 14). Regarding claim 22, CN ’12 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.
Claim(s) 7 is rejected under 35 U.S.C. 103 as being unpatentable over (CN 108525012 alternatively in view of Yoo et al. (WO 2014/011891) and in view of Teoh et al. (2007/0083268) as applied to claim 6 above, and further in view of Cordaro (10117746). CN ‘012 alternatively modified with Yoo et al. and in view of Teoh et al. is explained supra. However, CN ‘012 alternatively in view of Yoo et al. and in view of Teoh 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 Teoh et al. such that it provides multiple pathways for cell integration, see claim 1 of Cordaro.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Barrett can be reached at 571-272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BRIAN E PELLEGRINO/Primary Examiner, Art Unit 3799