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 .
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.
Claims 1-2, 5-8, 10-11, 14-16 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Ricotti et al. (2022/0168470) “Ricotti” in view of Kim et al. (2017/0179370) “Kim”.
Regarding claims 1 and 10, Ricotti discloses a method and system for osteoarthritis treatment (Fig. 4 and abstract), the method comprising: providing a cartilage hydrogel (abstract, par. 0051 and Fig. 2 disclose treating cartilage with a hydrogel polymer matrix), the cartilage hydrogel including piezoelectric nano-particles (par. 0038 discloses the hydrogel matrix includes piezoelectric nanotubes and nanorods), injecting 20 the cartilage hydrogel 10 into a cartilage defect (par. 0098 and Fig. 2 disclose injecting the hydrogel at the cartilage defect); applying an ultrasonic treatment 30 to the cartilage defect (par. 0099 and Fig. 3 disclose applying ultrasound treatment 30); and in response to applying the ultrasonic treatment to the cartilage defect, converting a mechanical impact of the ultrasonic treatment into an electrical charge from the piezoelectric nano-particles (par. 0099 discloses stimulating the piezoelectric nanoparticles using ultrasound treatment 30 to generate electric charges), and providing, in response to the electrical charge from the piezoelectric nano-particles, chondrogenesis differentiation for cartilage regeneration for the cartilage defect (pars. 0031 and 0099 disclose the ultrasound treatment stimulates the nano-particles to generate electric charge that have a chondrogenic effect on the cells 13 in the hydrogel matrix). Ricotti is silent regarding the cartilage hydrogel including piezoelectric nano-fibers of Poly-L-lactide (PLLA). However, Kim teaches a similar piezoelectric material (abstract) comprising piezoelectric nano-fibers of Poly-L-lactide (PLLA) (abstract and pars. 0022-0023 disclose piezoelectric material made of PLLA electrospun nanofibers). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the piezoelectric nano-particles in the cartilage hydrogel of Ricotti to include piezoelectric nano-fibers of Poly-L-lactide (PLLA), as taught and suggested by Kim, for using materials that exhibit superior piezoelectric properties and higher thermal stability (abstract and par. 0022).
Furthermore, regarding claim 10, the claimed phrase “is injected into a cartilage defect” is being treated as a product-by-process limitation and a product-by-process claim is not limited to the manipulations of the recited steps, only the structure implied by the steps. 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. MPEP 2113.
Regarding claims 2 and 11, Ricotti discloses wherein applying the ultrasonic treatment to the cartilage defect includes directly applying the ultrasonic treatment to the cartilage defect (par. 0100 and Fig. 3).
Regarding claims 5 and 14, Ricotti discloses providing the cartilage hydrogel includes providing a cartilage hydrogel that is biocompatible and biodegradable (abstract discloses biodegradable polymer matrix which is biocompatible).
Regarding claims 6-8 and 15-16, Ricotti discloses the claimed invention of claim 1 including fabricating the cartilage hydrogel (par. 0070); except for electrospinning aligned PLLA nano-fibers and wherein fabricating the cartilage hydrogel includes generating a piezoelectric property of the piezoelectric nano-fibers of PLLA by annealing and stretching nano-fibers of PLLA after electrospinning the aligned PLLA nano-fibers. However, Kim discloses a similar method comprising electrospinning aligned PLLA nano-fibers (par. 0022) and wherein fabricating the cartilage hydrogel includes generating a piezoelectric property of the piezoelectric nano-fibers of PLLA by annealing and stretching nano-fibers of PLLA after electrospinning the aligned PLLA nano-fibers (par. 0008 and 0009 disclose stretching the PLLA nano-fibers and par. 0025 discloses annealing the PLLA nano-fibers). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of fabricating the cartilage hydrogel of Ricotti to include electrospinning aligned PLLA nano-fibers and wherein fabricating the cartilage hydrogel includes generating a piezoelectric property of the piezoelectric nano-fibers of PLLA by annealing and stretching nano-fibers of PLLA after electrospinning the aligned PLLA nano-fibers as taught and suggested by Kim, for fabricating PLLA nano-fibers that exhibit superior piezoelectric properties and higher thermal stability (abstract and par. 0022).
Furthermore, regarding claims 15-16, the claimed phrase “is fabricated by electrospinning” and “by annealing and stretching nano-fibers of PLLA after electrospinning the aligned PLLA nano-fibers” is being treated as a product-by-process limitation and a product-by-process claim is not limited to the manipulations of the recited steps, only the structure implied by the steps. 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. MPEP 2113.
Regarding claim 18, Ricotti discloses wherein the electrical charge is a surface charge that promotes the chondrogenesis differentiation (Fig. 3 and par. 0020 discloses a local charge).
Claims 3-4 and 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Ricotti et al. (2022/0168470) “Ricotti” in view of Kim et al. (2017/0179370) “Kim” further in view of Thanos et al. (2019/0201323) “Thanos”.
Ricotti in view of Kim discloses the claimed invention of claim 1 including providing a cartilage hydrogel that includes the piezoelectric nano-fibers of PLLA (claim 1 above); except for providing a cartilage hydrogel that includes a collagen hydrogel with adipose-derived stem cells. However, Thanos teaches a similar PLLA hydrogel comprising collagen (par. 0096) with adipose-derived stem cells (par. 0141 discloses somatic stem cells). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the cartilage hydrogel of Ricotti in view of Kim to include collagen with adipose-derived stem cells, as taught and suggested by Thanos, for enhancing and controlling tissue integration (par. 0096).
Claims 9 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Ricotti et al. (2022/0168470) “Ricotti” in view of Kim et al. (2017/0179370) “Kim” further in view of Hazot et al. (2017/0306295) “Hazot”.
Ricotti in view of Kim discloses the claimed invention of claim 1 including wherein injecting the cartilage hydrogel into the cartilage defect includes injecting the cartilage hydrogel into the cartilage defect (Fig. 2 and par. 0098); except for via an arthroscopic procedure. However, Hazot teaches a similar method of injecting hydrogel by arthroscopy (pars. 0037 and 0077). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Ricotti in view of Kim to include injecting the cartilage hydrogel into the cartilage defect via an arthroscopic procedure, as taught and suggested by Hazot, for allowing the surgeon to visualize the cartilage repair site.
Furthermore, regarding claim 17, the claimed phrase “is injected into the cartilage defect via an arthroscopic procedure” is being treated as a product-by-process limitation and a product-by-process claim is not limited to the manipulations of the recited steps, only the structure implied by the steps. 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. MPEP 2113.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YASHITA SHARMA whose telephone number is (571)270-5417. The examiner can normally be reached on 8am-5pm M-Th; 8am-4pm Fri (MT).
If attempts to reach the examiner by telephone are unsuccessful, the examiner' s supervisor, Jerrah Edwards, can be reached at 408-918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/YASHITA SHARMA/
Primary Examiner, Art Unit 3774