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 § 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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-15, 17, 19-20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Xu et al. 2020/03796160 (hereafter ‘160) .
The applied reference has a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Regarding claims 1 and 14, Xu et al. ‘160 discloses a method for producing a tissue product, comprising the steps of: selecting an adipose tissue; treating the tissue to remove substantially all cellular material from the tissue; suspending the tissue in a liquid to form a suspension (see [0004] with a 2-4% by weight solid content (see claim 1 of Xu et al. ‘160); adding tropoelastin to the suspension (see [0061]); and freezing and drying the suspension to form a porous sponge.
Regarding claim 2 see [0061]; Regarding claim 3 see [0043]; Regarding claim 4 see [0055; 0059]; Regarding claims 5-8 see [0056] and claims 5-8 of Xu et al. ‘160; Regarding claims 9-13, 15 see claims 9-13 of Xu et al. ‘160; Regarding claim 17 see ‘160 [0025]; Regarding claim 19 see [0028] of ‘160; Regarding claim 20 see [0024].
Claim Rejections - 35 USC § 103
4. 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.
5. Claim 16 is rejected under 35 U.S.C. 103 as being obvious over by Xu et al. 2020/03796160 (hereafter ‘160). The applied reference has a common invention with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). Regarding claim 16, Xu et al. ‘160 has been disclosed supra however does not specifically disclose “…the sponge comprises a ratio of AAM to TE of about 3:1 to about 1:3. MPEP 2173.05 III states:
“III. APPROXIMATIONS
A. "About"
In determining the range encompassed by the term "about," one must consider the context of the term as it is used in the specification and claims of the application. Ortho-McNeil Pharm., Inc. v. Caraco Pharm. Labs., Ltd., 476 F.3d 1321, 1326, 81 USPQ2d 1427, 1432 (Fed. Cir. 2007). In W.L. Gore & Associates, Inc. v. Garlock, Inc., 721 F.2d 1540, 220 USPQ 303 (Fed. Cir. 1983), the court held that a limitation defining the stretch rate of a plastic as "exceeding about 10% per second" is definite because infringement could clearly be assessed through the use of a stopwatch. However, in another case, the court held that claims reciting "at least about" were invalid for indefiniteness where there was close prior art and there was nothing in the specification, prosecution history, or the prior art to provide any indication as to what range of specific activity is covered by the term "about." Amgen, Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200, 18 USPQ2d 1016 (Fed. Cir. 1991).
Xu et al. ‘160 teaches that the sponge comprises that the tropoelastin hydrogel was then cut and incorporated into the AAM slurry to a final concentration of 1% see [0061]. It is obvious to one having ordinary skill in the art that this percentage is about 3:1 to about 1:3 ratio.
6. Claim 18 is rejected under 35 U.S.C. 103 as being obvious over by Xu et al. 2020/03796160 (hereafter ‘160) in view of Ensley et al. 2013/0164340. The applied reference has a common invention with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
Regarding claim 18 Xu et al. does not specifically state that the TE is human TE. Ensley et al. teaches that human tropoelastin (TE) may be utilized in the production of implants and grafts (see abstract and [0014; 0192]. It would have been obvious to one having ordinary skill in the art to modify Xu et al. ‘160 and utilize human TE in order to customize the implant for patients’ bodies that my reject synthetic material.
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Conclusion
7. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Suzette Gherbi whose telephone number is (571)272-
4751. The examiner can normally be reached on Monday-Friday 7:00am-3:00pm. 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:/Avww.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Melanie Tyson can be reached on 571-272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SUZETTE J GHERBI/Primary Examiner, Art Unit 3774 June 3, 2026
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