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 without traverse of Group I (claims 1-7 and 17-19) in the reply filed on 7/29/2026 is acknowledged.
Claims 9-10 and 20-25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected groups, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/29/2026.
Claims 1-7 and 17-19 are under consideration in this office action.
Claim Rejections - 35 USC § 112
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 3 and 17 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 3 recites, “wherein the osmolarity ranges from about 270 to about 310 mOsmole/kg.” Whatever the recitation does not refer back an clear solution that would have osmolarity. As such, the claims lack sufficient antecedent basis and is indefinite because it is not apparent to what the claim refers. For purposes of interpretation and applying relevant art, the claim limitations are will deemed to be met if the structural limitations are disclosed or taught by an art.
Claim 17 recites, “The method of claim 6”. However claim is a composition not a method. As such, it is not apparent if Applicant intends to claim a method or a product in this claim. For purposes of interpretation, the claims will be interpreted as reciting “the composition of claim 6”.
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)(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.
Claim(s) 1-3, 7, and 18-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Luo (CN109082408 pub date: 12/25/2018 Translation pp. 1-6).
Regarding claim 1, Luo discloses adipose tissue rinsed in a crystal liquid. Luo also discloses resuspending adipose derived stem cells in a crystal liquid. Luo discloses the crystal liquid is sodium acetate ringer solution (p. 4, method for separating adipose derived stem cells). Both the adipose tissue and the adipose derived stem cells in sodium acetate ringer solution encompass the limitations of the claimed composition because CD34+ ASCs are a subpopulation of cells present in both adipose tissue and adipose derived stem cells. As such, Luo discloses the limitations of claim 1.
Regarding claim 2, Ringer solution is a well established solution in the prior art comprising sodium, potassium, and salts, often also comprising magnesium. As such, a disclosure of Ringer solution disclosed by Luo discloses the limitations of claim 2.
Regarding claim 3, Luo’s disclosure of Ringer solution comprising the limitations of about 270 to 310 mOsmol/kg because Ringer solution has said osmolaltity. Regarding claim 7, Luo discloses digesting the adipose tissue in collagenase and then adding sodium acetate Ringer solution to the digestions to stop the digestion (p. 5, lines 18-21). Collagenase is a protein. As such, Luo’s disclosure of adipose tissues, collagenase, and sodium acetate Ringer solution disclose the limitations of claim 7.
Regarding claims 18 and 19, Luo discloses placing the collected fat tissue in sodium acetate ringer solution to wash the collected fat tissue to remove red blood cells (p. 5, lines 13-14). The first wash of the collected fat tissue would comprise red blood cells, which also comprises hemogloblin which is a globular protein as claimed (claim 18) more particularly a globin protein as claimed (claim 19). It is further noted that the disclosed presence of red blood cells with the collected fat tissue could alone be present because blood was present. So while Luo does not expressly disclose that serum albumin was present in the first wash, inherently it had to be present because blood would have to have been present for the express disclose of red blood cells presence, disclosed by Luo, in the washing phase. As such, Luo expressly or inherently discloses the limitations of claims 18 and 19.
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) 4-6 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Luo (CN109082408 pub date: 12/25/2018 Translation pp. 1-6), as applied to claims 1-3, 7, and 18-19 above, and further in view of Gao (CN 110368402 pub date 10/25/2019 Translation pp. 1-7)
Regarding claims 4-6 and 17, Luo teaches the composition comprising CD34+ adipose tissue derived stem cells and sodium acetate as discussed above. Luo does not teach the composition further comprises a thrombin inhibitor (claim 4), more particularly heparin (claims 5 and 6), more particularly a molecular-weight heparin (claim 17).
However, Goa teaches medium for adipose derived mesenchymal stem cells comprising human serum albumin, low molecular weight heparin, compound amino acids, vitamin C, and compound electrolytes. Gao further discloses that the compound electrolytes comprise sodium chloride, sodium gluconate, sodium acetate, potassium chloride, and magnesium chloride (p 5). Thus Gao teaches that stem cell preparations from adipose tissues which comprise both hematopoietic and mesenchymal stem cells are commonly cultured in medium comprising electrolytes as seen in Luo as well and low molecular weight heparin.
As such, it would have been obvious to an artisan of ordinary skill at the time of effectively filing to use commonly-known, prior-art, adipose tissue-derived stem cell media components as seen in Gao and Luo, in particularly to include a low molecular weight heparin as taught in Gao to predictably arrive at the composition of claims 4-6 and 17. One would have been motivated to do so because both Gao demonstrates that the electrolytes and heparin are prior art known element used in prior art known methods of preparing adipose derived stem cell preparations. The artisan would also have a reasonable expectation of success because all of the media elements taught by both Luo and Gao are used with adipose tissue derived stem cell preparations successfully.
The combination of prior art cited above in all rejections under 35 U.S.C. 103 satisfies the factual inquiries as set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966). Once this has been accomplished the holdings in KSR can be applied (KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. 389, 82 USPQ2d 1385 (2007): "Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) "Obvious to try" - choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention."
In the present situation, rationales A and E are applicable. The claimed method was known in the art at the time of filing as indicated by Luo in view of Gao. Thus, the teachings of the cited prior art in the obviousness rejection above provide the requisite teachings and motivations with a clear, reasonable expectation. The cited prior art meets the criteria set forth in both Graham and KSR.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARCIA STEPHENS NOBLE whose telephone number is (571)272-5545. The examiner can normally be reached M-F 9-5:30.
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MARCIA S. NOBLE
Primary Examiner
Art Unit 1632
/MARCIA S NOBLE/Primary Examiner, Art Unit 1632
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