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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Acknowledgment is made of applicants' claim for foreign priority to Chinese applications CN 202110932618.1 filed on 08/13/2021. Certified copies of the foreign priority document(s) are present in the application file.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 04/29/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
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 1-10 are 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.
Regarding claim 1: The claim encompasses a cell preservation solution comprising any and all a compound electrolyte; vitamins and amino acid. It is submitted that the specification only describes a limited number of specific electrolytes, vitamins (C, thiamine, riboflavin, pyridoxine, sodium pantothenate, niacinamide, folate, biotin and B12) and particular amino acids (alanine, 2.10 g of arginine, 0.63 g of aspartic acid, 0.05 g of cystine, 1.05 g of glutamic acid, 1.48 g of glycine, 1.2 g of histidine, 1.48 g of leucine, 1.05 g of isoleucine, 1.05 g of methionine, and 1.48 g of phenylalanine) (See specification [0018]-[0019]). The specification does not describe representative species commensurate with the breadth of the claimed genera., nor does it identify structural or any common characteristics that would allow one of ordinary skill in the art recognize that the Applicant was in possession of the claimed invention.
As such while providing support for specific embodiments, the specification did not reasonably convey possession of full-scope of claim 1 and lacks written description.
Regarding claim 4-5: The claim recites 0.93-1.72 g/ml of sodium chloride, 0.86-1.44 g/ml of sodium gluconate, 0.64-1.44 g/ml of sodium acetate, 0.04-1.44 g/ml of potassium chloride, and 0.04-1.44 g/mL of magnesium chloride. The recited concentrations are inconsistent with the concentrations described in the specification.
For example, the specification recites: “Every 1000 ml of the compound electrolyte injection comprises: 5.26 g of sodium chloride, 5.02 g of sodium gluconate, 3.68 g of sodium acetate, 0.37 g of potassium chloride, and 0.30 g of magnesium chloride.” (See [0116]). Table 1 indicated that 215-240 ml of the compound electrolyte solution is used in the cell preservation solution
Component
Recited stock (Component electrolyte injection from [0116])
Final concentration in CEO1S cell preservation solution
Sodium chloride
5.26 g/L
4.52g/L-5.04g/L
sodium gluconate
5.02g/L
4.32g/L-4.8g/L
sodium acetate
3.68g/L
3.16g/L-3.53g/L
potassium chloride
0.37g/L
0.32g/L-0.36g/L
magnesium chloride
0.30g/L
0.26g/L-0.29g/L
The claimed concentrations seem very high and the office is unable to reconcile the disclosed formulations with the concentration ranges recited in recited in claim 4, particularly the units of g/ml. Accordingly the originally filed concentrations does not reasonably convey possession of the concentrations ranges presently recited in claim 4. Applicant is invited to identify where the originally filed specification expressly or inherently supports the claimed concentration ranges and units or the amend the claims and the specification to correspond to originally filed disclosure without adding new subject matter. Similar rejection applies to claim 5.
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.
Claim 10 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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 10 is directed to the use of a preservation solution of claim 1. However, the claim does not set forth any steps involved in the method/process, it is unclear what method/process applicant is intending to encompass. A claim is indefinite where it merely recites a use without any active, positive steps delimiting how this use is actually practiced.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-4 and 6-10 are rejected under 35 U.S.C. 101 because of the reasons indicated below.
Claim 10: The claim is directed to use of the preservation solution according to any one of claims 1-5 in the preservation of adipose-derived mesenchymal stem cells not directed to a process, machine, manufacture or composition. As such the claims recite a use, without setting forth any steps involved in the process, results in an improper definition of a process, i.e. results in a claim which is not a proper process under 35 U.S.C. 101. See for example Ex parte Dunki, 153 USPQ678 (Bd.App.1967) and Clinical Products, Ltd. v. Brenner, 255 F. Supp.131, 149 USPQ 475 (D.D.C.1966). (Step 1: NO).
Claims 1-4 and 6-10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more.
The claims are patent ineligible.
Claim 1: The claims are directed to a cell preservation solution comprising buffer, glucose, sodium chloride, amino acids and vitamins.
The claim is directed to a composition of matter, which is a statutory category of invention. (Step 1: YES).
The claim is then analyzed to determine whether it is directed to any judicial exception. The claim is directed to a cell preservation solution that comprises all the indicated components. This encompasses naturally occurring substances such as blood. As such the claim describes a naturally occurring product. (See Premnath, p. 1-2; See PTO-892). Thus, the claim recites at least one exception, which may be termed a product of nature. (Step 2A prong 1: YES).
The claim is then analyzed to determine if additional elements integrate the
judicial exception into a practical application. The claim recites that the solution is a cell preservation solution, which also reads on blood. (Step 2A prong 2: NO). Therefore, the claim is directed to a law of nature judicial exception.
The claim is patent ineligible.
Additionally, claims 2-4 do not impart a markedly different characteristic to any of the components as a whole and are therefore ineligible for the same reason.
Regarding claims 6-9: These claims are directed to a mixture of adipose derived MSCs and cell preservation solution such as blood. It is noted that adipose derived MSCs are naturally present in subcutaneous fat tissue. (See Wu Sec. 2.3; PTO-892). It does not appear that the mixing the two naturally occurring substances together, imparts any markedly different characteristics to either blood or subcutaneous fat. As such, similar analyses apply to the indicated claims, and they are patent ineligible.
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.
Claims 1, 2, 6, 8, and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Guangzhou et al (CN104542578B; published 2017-01-18; See PTO-892 and English translation appended at the end) further as evidenced by Vitamin C (FactSheet for Health Professionals, See PTO-892) and Nomoto et al (Front. Cell Dev. Biol.; Published 2021; herienafter "Nomoto;" See PTO-892).
Regarding claim 1, 2, 8 and 10: Guangzhou taught a cell preservation medium comprising multiple electrolytes, amino acid compound injection, glucose, and vitamin c for storing cells at 0-4 degrees C (See Guangzhou, English translation, p9-10, embodiments 1-3). Further, claim 6 of Guangzhou indicated that the multiple electrolyte solution includes sodium chloride, sodium gluconate, sodium acetate trihydrate. sodium gluconate, sodium acetate trihydrate read on the claimed compound electrolyte. Vitamin C reads on the claimed water-soluble vitamin (See evidence in NIH-Vitamin C). It is also noted that claim 5 taught the amino acid as aspartate, arginine, histidine, threonine among others, which are water soluble amino acids (See Nomoto, Table 1).
Regarding claim 6: Claim 8 of Guangzhou taught a cell (mesenchymal stem cell) in the preservation liquid. It is also submitted that Mesenchymal stem cell is a fat-derived mesenchymal stem cell. (See Guangzhou p. 6, 2nd para).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claims 3-5, 7 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Guangzhou et al (CN104542578B; published 2017-01-18; See PTO-892 and English translation appended at the end) further as evidenced by Vitamin C (FactSheet for Health Professionals, See PTO-892) and Nomoto et al (Front. Cell Dev. Biol.; Published 2021; hereinafter "Nomoto;" See PTO-892).
Regarding claim 3-4: Guangzhou disclosed the same exact stock electrolyte solution. (See Guangzhou p.6 of English translation, last paragraph). Guangzhou taught preparing a cell preservation solution using the identical compound electrolyte injection and compound amino acid injection, further taught mixing the solutions 1:1-1:2 prior to the addition of the remaining components. (See Guangzhou, English translation, p9-10, embodiments 1-3). Because the concentrations of the individual components for example, sodium chloride, sodium gluconate etc in the final solution directly depend on the relative proportion of the known compound electrolyte injection, optimization amount of compound electrolyte injection to obtain the desired final electrolyte concentration would have been a matter of routine optimization of result-effective variable.
Similarly, regarding claim 3, relative concentrations of amino acid solution incorporated into the final preservation solution is a result-effective variable, that affects the composition and properties of the preservation solution. It would have been obvious for a person of ordinary skill in the art to routinely optimize the amino acid solution including selecting the volume percentage within the claimed range for the same reasons stated above.
Regarding claim 5: It is noted that Guangzhou used glucose at 3%, 5%, and 8%, thus recognizing that the concentration is a result effective variable. (See Guangzhou, English translation, p9-10, embodiments 1-3). It is submitted that the claimed concentration is an optimization of glucose amount in the preservation solution. A person of ordinary skill in the art would have been motivated to adjust the amount of glucose depending on the preservation conditions and would have expected that varying the glucose concentration within a workable range would produce predictable results.
Regarding claim 7: It is noted that Guangzhou taught 1-5x106 cells/ml/ (See Guangzhou, English translation, p11, first para), thus, recognizing that the concentration is a result effective variable. It is submitted that the claimed concentration is an optimization of cell concentration is a result effective variable. A person of ordinary skill in the art would have been motivated to adjust the amount of glucose depending on the preservation conditions and would have expected that varying the cell concentration within a workable range would produce predictable results.
Regarding claims 9: The teachings of Guangzhou are set forth above. To the extent claim 9 recites a “repository of adipose-derived mesenchymal stem cells,” such limitation merely describes storing or maintaining a collection of preserved adipose-derived mesenchymal stem cells. Establishing a repository of preserved cells would have been an obvious and routine use of a known preserved cell mixture, because cell banking and repository formation are conventional applications of preserved cell preparations.
A person of ordinary skill in the art would have been motivated to store preserved adipose-derived mesenchymal stem cells prepared according to Guangzhou to maintain a supply of cells for subsequent use, with a reasonable expectation that the preserved cells could be retrieved and utilized.
Accordingly, the claimed repository represents no more than the predictable use of the preserved cell mixture taught by Guangzhou.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAGAMYA VIJAYARAGHAVAN whose telephone number is (703)756-5934. The examiner can normally be reached 9:00a-5:00p.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christopher M. Babic can be reached at 571-272-8507. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAGAMYA NMN VIJAYARAGHAVAN/ Examiner, Art Unit 1633
/EVELYN Y PYLA/ Primary Examiner, Art Unit 1633
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