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 .
Applicant’s election with traverse of Group I, claims 1-7, in the reply filed on 8 January 2026 is acknowledged.
Applicant’s traversal is based on the assertion that with the amendments made to the claims, the special technical feature of "adipose matrix comprising devitalized and partially delipidized adipose tissue and exogenous cells" and "wherein the devitalized and partially delipidized adipose tissue is not decellularized" is not taught or suggested by the cited prior art. This is unpersuasive, since as put forth in the rejection below, such a composition combining an adipose matrix with exogenous cells is known in the prior art.
Status of the Claims
Claims 10, 11, 15-25, 27-38, 40, 42, 43, 45-47, 49-57 and 59-67 have been cancelled.
Claim 12 has been amended to be dependent on claim 1.
Claims 26, 39, 41, 44, 48, 58, 68 and 69 are withdrawn as being directed to nonelected inventions.
Claims 1- 8 and 12-14 are presented for examination on the merits.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1- 8 and 12-14 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The amendments made to claim 1 are deemed to be new matter that is not supported by the specification. Specifically, the added phrase “wherein the devitalized and partially delipidized adipose tissue is not decellularized”. Any reference to such a negative limitation as the adipose tissue matrix not being “decellularized” could not be found in the specification.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1- 8 and 12-14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 is rendered vague and indefinite by the phrase “[a] adipose matrix comprising ….
Firstly, it is unclear whether the claims should be directed to a “composition”,
Which Applicant defines in paragraph [00068] of the specification the adipose matrix alone or the adipose matrix in combination with something else, such as MSCs or a pharmaceutically acceptable carrier, rather than an “adipose matrix” that contains those two components. That is- it is unclear how a matrix itself can contain delipidized adipose tissue and exogenous cells.
Secondly, the phrase “partially delipidized” is unclear, since partially is a vague term without clear technical scope. The term “partially” is a relative term which renders the claim indefinite. The term is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Thirdly, claim 1 recites the limitation "the original lipids" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Finally, the term “devitalized” is unclear. Applicant states in the specification that term "devitalized" means at some point 100% of the native cells (e.g., cells that originated from the adipose tissue) have been killed and at least a portion of the killed cells (i.e., nonviable cells) are present in the adipose tissue. In some aspects, a devitalized adipose tissue can later be populated with cells; however, if the adipose tissue was initially devitalized then even after populating with cells at a later step the adipose tissue can still be referred to as devitalized. In some aspects, devitalized adipose tissue can mean that some of the dead cells can be lost during processing, but at least 98% of the dead cells are still present in the tissue.
In fact, it is not clear if the terms “devitalized” and “decellularized” are mutually exclusive, as the specification states that devitalized adipose tissue can mean that some of the dead cells can be lost during processing. Thus it is not clear what is meant by “devitalized” adipose tissue cells other than dead cells, which appears to be achieved by freezing of the adipose tissue. However, such treatment could also be considered to result in decellularization. As such, adipose tissue that has been extracted from the donor, and is thus no longer present and functioning within the body, is deemed to be "devitalized" adipose tissue.
All other claims depend directly or indirectly from rejected claims and are, therefore, also rejected under U.S.C. 112, second paragraph, for the reasons set forth above.
Note: “[W]here there is a great deal of confusion and uncertainty as to the proper interpretation of the limitations of a claim, it would not be proper to reject such a claim on the basis of prior art. As stated in In re Steele, 35 F.2d 859, 134 USPQ 292 (CCPA 1962), a rejection under 35 USC 103 should not be based on considerable speculation about the meaning of terms employed in a claims or assumptions that must be made as to the scope of the claims.” MPEP 2173.06 II.
However, in order to practice compact prosecution for purposes of examination the claims as drafted are given their broadest reasonable interpretation. In the instant case, the term “devitalized” is taken as meaning the same as “decellularized” absent evidence to the contrary.
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, 5-8 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- 8 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- 8 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.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
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.
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/RUSSELL G FIEBIG/Examiner, Art Unit 1655