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 .
The amendment filed 20 April 2026 is acknowledged and has been entered.
Status of the Claims
Claims 10, 11, 15-25, 27-38, 40, 42, 43, 45-47, 49-57 and 59-67 have been cancelled.
Claims 26, 39, 41, 44, 48, 58, 68 and 69 are withdrawn as being directed to nonelected inventions.
Claims 1- 9 and 12-14 are presented for examination on the merits.
Claim Rejections - 35 USC § 102
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 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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(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, 5-9 and 12 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Huang et al. (US2017/0021058).
Huang et al. disclose an cellular soft tissue-derived matrix from adipose tissue (claim 8) comprising partially delipidized adipose tissue (delipidizing step c comprises removing most (i.e., more than 51%) of the lipids from the tissue [0575]. The reference discloses a composition, comprising delipidated, decellularized adipose tissue (claim 1); methods of preparation of the decellularized adipose matrix (claim 8, [0661]); decellularization may be performed by micronization [0680]; and it envisages the combination with MSCs [0544].
Claim(s) 1, 5-8 and 12 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Nahas et al. (US2012/0189588).
Nahas et al. disclose a composition comprising processed adipose tissue comprising a decellularized (i.e., devitalized) adipose tissue extracellular matrix to which viable cells securely attach (claim 1); the preparation of which involves lipid and cell removal [0025], i.e., delipidation and devitalization. Furthermore, the viable cells can include MSCs [0057].
Claim(s) 1, 5-8 and 12 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Christman et al. (US2012/0264190).
Christman et al. disclose a composition comprising a decellularized and delipidized extracellular matrix derived from adipose tissue (claim 1); further comprising exogenous cells, e.g., MSCs (claim 8, 10).
Thus the cited claims are deemed to be anticipated by each of the cited references.
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1254-1255, 195 U.S.P.Q. (BNA) 430, 432-33 (C.C.P.A. 1977).
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.
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.
Claim(s) 1- 9 and 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over the above cited prior art such as Huang et al. (US2017/0021058) in view of Wang et al. (2013) and Flynn et al. (2010).
Huang et al. is cited for the teachings as set forth above.
Wang et al. beneficially discloses methods of combining of decellularized human adipose tissue extracellular matrix (hDAM) with human adipose-derived stem cells (hASCs) for tissue engineering, comprising lipid removal. Freeze-thaw cycles were performed resulting in decellurization/devitalization and sequential washing and agitation steps with: water, NaCl, trypsin/EDTA and isopropanol (IPA), Triton-X-100 and PBS, which effectively removed lipids (see entire document, including e.g., abstract, section 2.1, Figure 1).
Flynn et al. beneficially teach the combination of decellularized adipose tissue matrices with MSCs, wherein the method to obtain the matrices comprises an IPA lipid extraction step (section 2.3).
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the claimed invention to combine the instant ingredients an adipose tissue matrix and exogenous cells such as MSCs since each is well known in the art as evidenced by the cited references.
In KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007), the Supreme Court emphasized a flexible approach to the obviousness question, stating that the analysis under 35 U.S.C. § 103 "need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ." Id. at 418; see also id. at 421 ("A person of ordinary skill is... a person of ordinary creativity, not an automaton."). In KSR, the Supreme Court indicated that the obviousness analysis should consider the “background knowledge possessed by a person having ordinary skill in the art.” KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398 (2007). Under KSR, information deemed within PHOSITA’s general knowledge is more powerful than that found buried in a prior art reference because we assume that PHOSITA would consider using their general knowledge in combination with the prior art — even absent any express motivation to do so. Under 35 U.S.C. § 103, the obviousness inquiry turns not only on the prior art, but whether “the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious . . . to a person having ordinary skill in the art to which the claimed invention pertains.” 35 U.S.C. § 103. Regardless of the tribunal, the inquiry into whether any “differences” between the invention and the prior art would have rendered the invention obvious to a skilled artisan necessarily depends on such artisan’s knowledge.
It is well known in the prior art to employ adipose tissue derived matrices as a delivery vehicle for active components such as stem cells. The adjustment of particular conventional working conditions (e.g., determining the optimal amount of delipidation, employing common techniques such as cryopreservation, lyophilization, etc. is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan.
Accordingly, the instant claims, where no unexpected results are observed, would have been obvious to one of ordinary skill having the above cited references before him/her.
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- 9 and 12-14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17, 33, 34, and 36 of copending Application No. 17887013 and claims 1-4 and 14-16 of copending Application No. 18614296 in view of the prior art references cited above.
Although the claims at issue are not identical, they are not patentably distinct from each other because both encompass a composition comprising devitalized adipose tissue, wherein the devitalized adipose tissue comprises at least 50% of the native lipids, wherein the devitalized adipose tissue comprises at least 70% of the
native growth factors; wherein the devitalized adipose tissue comprises less than 5% of the native viable cells; wherein the devitalized adipose tissue does not comprise free lipids; wherein the devitalized adipose tissue retains its native structure; wherein the growth factors inherently include angiogenic growth factors, vascular endothelial growth factors, insulin like growth factors, hepatocyte growth factor, platelet-derived growth factor, or fibroblast growth factors; and the devitalized adipose tissue is non-radiated; wherein the devitalized adipose tissue is lyophilized or has been previously cryopreserved.
It would have been obvious to combine such adipose-derived compositions as claimed with exogenous cells such as MSCs as taught by any of the cited prior art references.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant’s amendments/arguments, with respect to the 35 USC 112 rejections have been fully considered and are persuasive.
Applicant submits that paragraph [0109] of the as-filed specification recites "The dead cells can remain in the adipose tissue, thus the adipose tissue can be referred to as devitalized, not decellularized or not acellular." (emphasis added) Thus the specification clearly states "the adipose tissue can be referred to as devitalized and not decellularized" (emphasis added).
The 35 USC 112 rejection of the previous Office action has been withdrawn.
Applicant's amendments/arguments filed with respect to the prior art rejections have been fully considered but they are not persuasive.
Applicant attempts to distinguish the preparation of the instant Application by the characteristic of the adipose tissue being “devitalized”, which means that the cells are killed but not removed, that is - decellularized. But, as Applicant admits devitalized adipose tissue may lose some cells during processing. Thus, there is intrinsically at least some decellularization. It is unclear what Applicant considers a “sufficient quantity” of cell removal to be considered decellularization.
Applicant does not point out where in the cited prior art references “decellularization” (that is – removal of cells in a sufficient enough quantity to be considered decellularized) is actually performed.
THIS ACTION IS MADE FINAL. 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.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUSSELL G FIEBIG whose telephone number is (571)270-5366. The examiner can normally be reached M-F 8-4.
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, Anand Desai can be reached at 5712720947. 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.
/RUSSELL G FIEBIG/ Examiner, Art Unit 1655
Prosecution Insights