Prosecution Insights
Last updated: July 17, 2026
Application No. 18/513,797

CELL PRESERVATION SOLUTION, PREPARATION METHOD FOR SAME, AND APPLICATIONS THEREOF

Final Rejection §101§103§112
Filed
Nov 20, 2023
Priority
Mar 20, 2021 — CN 202110298828.X +3 more
Examiner
DHAR, MATASHA
Art Unit
1632
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Jiangsu Renocell Biotech Co. Ltd.
OA Round
2 (Final)
44%
Grant Probability
Moderate
3-4
OA Rounds
1y 0m
Est. Remaining
94%
With Interview

Examiner Intelligence

Grants 44% of resolved cases
44%
Career Allowance Rate
39 granted / 88 resolved
-15.7% vs TC avg
Strong +49% interview lift
Without
With
+49.4%
Interview Lift
resolved cases with interview
Typical timeline
3y 8m
Avg Prosecution
45 currently pending
Career history
139
Total Applications
across all art units

Statute-Specific Performance

§101
1.1%
-38.9% vs TC avg
§103
68.8%
+28.8% vs TC avg
§102
3.6%
-36.4% vs TC avg
§112
8.1%
-31.9% vs TC avg
Black line = Tech Center average estimate • Based on career data from 88 resolved cases

Office Action

§101 §103 §112
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 . Claims status Applicant’s reply filed 5/18/2026 is acknowledged. Claim 2 and 4 is/are cancelled. Claims 1, 3, 5-9 is/are currently pending and is/are under examination. Withdrawn Objections The objections presented herein represent the full set of objections currently pending in this application. Any objections not specifically reiterated are hereby withdrawn. Claim Objections – New, necessitated by claim amendments Applicant is advised that should claim 5 be found allowable, claim 6 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. Claims 5 and 6 are methods reciting identical method steps. Although the preamble of these claims recite different intended purposes for these methods (for manufacturing cell preparation vs preserving cells), these intended purposes do not result in a patentable distinction in scope of these claims that are directed to an identical method. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Claim Rejections - 35 USC § 112(b) - Withdrawn 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. Rejection of Claims 1-9 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 is withdrawn due to claim amendments and/or cancellation. Claim Rejections - 35 USC § 101 - Withdrawn 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. Rejection of Claims 5 and 6 under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter is withdrawn due to claim amendments. Claim Interpretation – Reiterated The term “compound amino acid injection” is recited in the claims. The specification does not provide a definition for this term nor does it identify the amino acids that are required to be included in the claimed “compound amino acid injection”. Various “compound amino acid injections” are commercially available and used in the art however a clear definition or standard is not established in the art. For example, Shi et al (Front. Nutr., June 2022, Volume 9, Article 880256; ref of record) states that “At present, there are many formulations of balanced amino acids for injection in China, produced by numerous manufacturers, with variations in the content and price. The total AA content, as well as the contents of the different EAAs, are related to the safety, effectiveness, and economy of these clinical medications” (page 2, col. 2, para 1). Wu et al (World Journal of Surgical Oncology (2015) 13:336; ref of record) teach a “compound amino acid injection” compositions compounded to comprise various amino acids (Tables 4 and 5). Since “compounds amino acid injections” can comprise any type of and any number of amino acids, the term “compound amino acid injection” is broadly interpreted to be a solution comprising at least one amino acid of any type. The term “compound amino acid injection 14AA” is recited in the claims. The specification does not provide a definition for this term nor does it identify the amino acids that are required to be included in the claimed “compound amino acid injection”. It is understood that compound amino acid injection 14AA comprises at least 14 amino acids. The term “compound electrolyte injection” is recited in the claims. The specification does not provide a definition for this term nor does it identify the electrolytes that are required to be included in the claimed “compound electrolyte injection”. It is understood that compound electrolyte injection is a solution that comprises electrolytes i.e. necessary salts, such as NaCl, KCl etc. Claim Rejections - 35 USC § 103 – New, necessitated by claim amendments 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. Rejection of Claim(s) 1, 3, 5-7 under 35 U.S.C. 103 as being unpatentable over Cheng et al (CN 108651442 A, 2018-10-16; Machine translation generated from PE2E SEARCH provided in the PTO-892. Citations in the rejection below are from the Machine translation) in view of Zhang et al (CN 109381457 A, 2019-02-26; Machine translation generated from PE2E SEARCH provided in the PTO-892. Citations in the rejection below are from the Machine translation) is withdrawn due to claim amendments. Rejection of Claim(s) 8, 9 under 35 U.S.C. 103 as being unpatentable over Cheng in view of Zhang as applied to claim 3 above, and further in view of Ge et al (CN 104542578 A, 2015-04-29; Machine translation generated from PE2E SEARCH provided in the PTO-892. Citations in the rejection below are from the Machine translation) and Basar et al (Hematology Am Soc Hematol Educ Program (2020) 2020 (1): 570–578.) is withdrawn due to withdrawal of the rejection the instant rejection depends from. Claim(s) 1 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cheng et al (CN 108651442 A, 2018-10-16; Citations in the rejection below are from the Machine translation; ref of record) in view of Zhang et al (CN 109381457 A, 2019-02-26; Citations in the rejection below are from the Machine translation; ref of record). Regarding claims 1, Cheng teaches a composition for cell preservation comprising essential and non-essential amino acids (=compound amino acid injection), L-glutamine and glucose (=anhydrous glucose because Cheng teaches glucose powder amount of 1-50mg/ml; see “glucose is 0.1%-5%mg/ml” on page 2-para 5; Note: 1%mg/ml = 10mg/ml) (Abstract). Cheng uses %mg/ml and %ml/ml units for some components. Note: 1%mg/ml = 10mg/ml = 1g/100ml; and 1%ml/ml = 0.01ml/ml = 1ml/100ml. Regarding compound amino acid injection, Cheng teaches “lysine, tryptophan, phenyl alanine, methionine, threonine, isoleucine, leucine, valine, glutamic acid, alanine, glycine, aspartic acid, cysteine, proline, serine and tyrosine” as amino acids and identifies this solution as “compound amino acids” in some embodiments (page 2, paras 6, 7, 8; page 4, para 7; Examples 3-5). Since Cheng’s compound amino acid injection comprises at least 14 amino acids, it is a compound amino acid injection 14AA (see claim interpretation above). Regarding the amount of compound amino acid injection, Cheng teaches 1%-10%ml/ml which equals 1-10ml/100ml and overlaps the claimed 1-5ml/100ml(page 2, para 5). See guidance from MPEP 2144.05 regarding overlapping ranges. In the instant case, in teaching a slightly broader range of 1-10ml/100ml, Cheng renders obvious the slightly narrower range of the claim i.e. 1-5ml/100ml. Regarding the amount of L-glutamine, Cheng teaches 1-10mM glutamine which equals 0.014-0.146g/100ml (=claimed 0.01-1g/100ml; page 2, para 5). Regarding the amount of glucose, Cheng teaches 0.1%-5%mg/ml which equals 0.1-5g/100ml and overlaps the claimed 0.1-1g/100ml(page 2, para 5). See guidance from MPEP 2144.05 regarding overlapping ranges. In the instant case, in teaching a slightly broader range of 0.1-5g/100ml, Cheng renders obvious the slightly narrower range of the claim i.e. 0.1-1g/100ml. Cheng does not teach a compound amino acid injection 14AA that is sulfite antioxidant-free. Further, Cheng does not explicitly teach a composition consisting of (closed transitional phrase; see MPEP 2111.03) only sulfite antioxidant-free compound amino acid injection 14AA, L-glutamine and anhydrous glucose. Regarding compound amino acid injection that is sulfite antioxidant-free, Zhang teaches a sulfite antioxidant-free compound amino acid injection comprising 14 amino acids (=claimed 14AA-SF; Abstract). Zhang teaches because amino acid solutions easily oxidize, antioxidants are added to them but use of traditional antioxidants such as sulfites have negative effects on human body and thus its use in medicine is limited (page 2, para 6 and 7). Zhang teaches a stable compound amino acid injection without sulfite (Summary of Invention, page 3). Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to substitute the stable compound amino acid injection without sulfite taught by Zhang in Cheng’s cell preservation solution. An artisan would be motivated to make such a substitution because it would make the compound amino acid injection component of Cheng’s cell preservation solution stable and of low hazard to humans. An ordinary artisan would reasonably expect to make such a substitution because Zhang teaches the composition of their compound amino acid injection on page 3 and an artisan would substitute this composition in Cheng’s cryopreservation solution. Additionally, Zhang teach methods to make compound amino acid injection in which oxygen content is constantly monitored and if oxygen amount increases in the solution then it is replaced with nitrogen, thus removing the need for an anti-oxidant (page 5, para 8,9). Thus, an ordinary artisan could reasonably produce a compound amino acid injection with any amino acids without sulfite-antioxidant using Zhang’s method. Regarding a composition consisting of only sulfite antioxidant-free compound amino acid injection 14AA, L-glutamine and anhydrous glucose, Cheng teaches a composition comprising the “composition for producing a cell preservation solution”, Cheng and Zhang teach each of its components and concentration/amounts (Abstract, page 2-para 5 from Cheng; Abstract from Zhang). Cheng does not teach first mixing only compound amino acid injection, L-glutamine and anhydrous glucose such that a composition consisting of only these components is first produced and then these are mixed with the rest of the ingredients to form the final cell preservation solution. However, order of mixing components such that a sub-combination of components is produced first resulting in a product that comprises a sub-combination of components is obvious. In re Gibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930) (Selection of any order of mixing ingredients is prima facie obvious.). See MPEP 2144.04(IV)(C). An ordinary artisan routinely mixes components to make solutions. An ordinary artisan mixing components taught by Cheng and Zhang could mix the components such that a sub-combination of components, as claimed in claim 1, is produced. ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions."). See also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416, 82 USPQ2d 1385, 1395 (2007) (identifying "the need for caution in granting a patent based on the combination of elements found in the prior art."). See MPEP 2144.05(II)(A). In the instant case, there is not even evidence of an improved product. Additionally, even the instant specification does not teach only the subcombination of claim 1 and a separate utility of this claimed subcombination. Therefore, in teaching a composition comprising the “composition for producing a cell preservation solution”, teaching each of its components and concentration/amounts, Cheng and Zhang render obvious a composition consisting of only these components, as claimed in claim 1. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the effective time of filing of the invention, especially in the absence of evidence to the contrary. Claim(s) 3, 5-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cheng et al (CN 108651442 A, 2018-10-16; Citations in the rejection below are from the Machine translation; ref of record) in view of Zhang et al (CN 109381457 A, 2019-02-26; Citations in the rejection below are from the Machine translation; ref of record). Regarding claim 3, Cheng teaches a cell preservation solution comprising human serum albumin (HSA), sodium lactate Ringer injection (=compound electrolyte injection), page 4-para 2), essential and non-essential amino acids (=compound amino acid injection), L-glutamine and glucose (=anhydrous glucose because Cheng teaches glucose powder amount of 1-50mg/ml; see “glucose is 0.1%-5%mg/ml” on page 2-para 5; Note: 1%mg/ml = 10mg/ml) (Abstract). Cheng uses %mg/ml and %ml/ml units for some components. Note: 1%mg/ml = 10mg/ml = 1g/100ml; and 1%ml/ml = 0.01ml/ml = 1ml/100ml. Regarding the amount of HSA, Cheng teaches 0.5%-5%mg/ml which equals 0.5-5g/100ml (page 2, para 5). The claim does not recite the amount or concentration of HSA in the 5-15ml HSA included in the 100ml cell preservation solution. An ordinary artisan preparing a stock solution of HSA to be added to the cell preservation solution could generate a HSA stock such that it results in 0.5-5g HSA being added, as taught by Cheng, in a volume of 5-15ml, as claimed, to the final 100ml volume of cell preservation solution. Additionally, the specification discloses the stock concentration of HSA to be 10g/50ml [0073]. Thus, 5-15ml of 10g/50ml HSA is equal to 1-3g of HSA included in 100ml cell preservation solution. Thus, in teaching HSA at 0.5-5g, Cheng teaches the narrower range of 1-3g or as claimed 5-15ml. Regarding the amount of compound electrolyte injection, Cheng teaches 86%-98%ml/ml which equals 86-96ml/100ml which overlaps the claimed 80-90ml (page 2, para 5). MPEP 2144.05 states “"[A] prior art reference that discloses a range encompassing a somewhat narrower claimed range is sufficient to establish a prima facie case of obviousness." In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003). ”. In the instant case, in teaching a slightly broader range of 86-96ml, Cheng renders obvious the slightly narrower range of the claim i.e. 80-90ml. Regarding compound amino acid injection, Cheng teaches “lysine, tryptophan, phenyl alanine, methionine, threonine, isoleucine, leucine, valine, glutamic acid, alanine, glycine, aspartic acid, cysteine, proline, serine and tyrosine” as amino acids and identifies this solution as “compound amino acids” in some embodiments (page 2, paras 6, 7, 8; page 4, para 7; Examples 3-5). Since Cheng’s compound amino acid injection comprises at least 14 amino acids, it is a compound amino acid injection 14AA (see claim interpretation above). Regarding the amount of compound amino acid injection, Cheng teaches 1%-10%ml/ml which equals 1-10ml/100ml and overlaps the claimed 1-5ml/100ml(page 2, para 5). See guidance from MPEP 2144.05 regarding overlapping ranges. In the instant case, in teaching a slightly broader range of 1-10ml/100ml, Cheng renders obvious the slightly narrower range of the claim i.e. 1-5ml/100ml. Regarding the amount of L-glutamine, Cheng teaches 1-10mM glutamine which equals 0.014-0.146g/100ml (=claimed 0.01-1g/100ml; page 2, para 5). Regarding the amount of glucose, Cheng teaches 0.1%-5%mg/ml which equals 0.1-5g/100ml and overlaps the claimed 0.1-1g/100ml(page 2, para 5). See guidance from MPEP 2144.05 regarding overlapping ranges. In the instant case, in teaching a slightly broader range of 0.1-5g/100ml, Cheng renders obvious the slightly narrower range of the claim i.e. 0.1-1g/100ml. Regarding claims 5-6, Cheng teaches the method of preserving cells, such as MSCs, in their cell preservation solution by re-suspending (=mixing) the cells in their solution and preserving it at 4°C (Example 2-4; Claim 6). Regarding claims 7, Cheng teaches use of their cell preservation solution for preserving mesenchymal stem cells (MSC), including preserving at 4°C, wherein the solution comprises MSCs (Abstract, Example 2-4; Claim 1). Cheng does not teach a compound amino acid injection 14AA that is sulfite antioxidant-free. Regarding sulfite antioxidant-free compound amino acid injection, Zhang teaches a sulfite antioxidant-free compound amino acid injection comprising 14 amino acids (=claimed 14AA-SF; Abstract). Zhang teaches because amino acid solutions easily oxidize, antioxidants are added to them but use of traditional antioxidants such as sulfites have negative effects on human body and thus its use in medicine is limited (page 2, para 6 and 7). Zhang teaches a stable compound amino acid injection without sulfite (Summary of Invention, page 3). Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to substitute the stable compound amino acid injection without sulfite taught by Zhang in Cheng’s cell preservation solution. An artisan would be motivated to make such a substitution because it would make the compound amino acid injection component of Cheng’s cell preservation solution stable and of low hazard to humans. An ordinary artisan would reasonably expect to make such a substitution because Zhang teaches the composition of their compound amino acid injection on page 3 and an artisan would substitute this composition in Cheng’s cryopreservation solution. Additionally, Zhang teach methods to make compound amino acid injection in which oxygen content is constantly monitored and if oxygen amount increases in the solution then it is replaced with nitrogen, thus removing the need for an anti-oxidant (page 5, para 8,9). Thus, an ordinary artisan could reasonably produce a compound amino acid injection with any amino acids without sulfite-antioxidant using Zhang’s method. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the effective time of filing of the invention, especially in the absence of evidence to the contrary. Claim(s) 8, 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cheng in view of Zhang as applied to claim 3 above, and further in view of Ge et al (CN 104542578 A, 2015-04-29; Machine translation generated from PE2E SEARCH provided in the PTO-892. Citations in the rejection below are from the Machine translation) and Basar et al (Hematology Am Soc Hematol Educ Program (2020) 2020 (1): 570–578.) The teachings of Cheng and Zhang as detailed in the U.S.C. 103 rejection above are relied upon for the instant rejection. Cheng teaches the use of their cell preservation solution for preserving mesenchymal stem cells (MSC), including preserving at 4°C, wherein the solution comprises the cells i.e. MSCs (Abstract, Example 2-4; Claim 1). Cheng does not teach the use of their cell preservation solution for preserving NK or CAR-T cells, including preserving at 4°C, wherein the solution comprises these cells. Ge teaches a cell preservation solution comprising albumin, glucose, compound electrolyte injection and compound amino acid injection, similar to Cheng (Abstract). Ge teaches use of cell preservation solutions for cells used in cell therapy such as MSCs, same as Cheng, but also the same solution for preserving other cells used in cell therapy such as immune cells, for e.g. CIK-cells which are NK-cell like T cells [0003-004, 0045-0066]. Basar teaches both NK-cells and CAR-T cells as immune cells commonly used in cell therapy (Learning objectives, Table 1). Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to use the cryopreservation solution of Cheng and Zhang to preserve other cells used in cell therapy such as NK and CAR-T immune cells. An ordinary artisan would be motivated to use Cheng’s cryopreservation solution to preserve NK and CAR-T immune cells because these cells are being widely used in human cell therapy, as taught by Basar, and thus require preservation between uses. An ordinary artisan would reasonably expect to preserve NK and CAR-T immune cells in Cheng’s cryopreservation solution because Ge teaches that cryopreservation solutions for MSCs are also applicable to immune cells. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the effective time of filing of the invention, especially in the absence of evidence to the contrary. Response to Arguments Applicant’s arguments with respect to U.S.C. 103 rejection of claim(s) 1, 3, 5-7 in view of Cheng and Zhang and, claims 8, 9 further in view of Ge and Basar have been considered but are moot because the new ground of rejection necessitated by claim amendments. Arguments pertinent to instant U.S.C. 103 rejection of claim(s) are addressed below: Regarding the combination of Zhang and Cheng, Application argue that “The purpose of Cheng and Zhang are different.” since Zhang is allegedly intended for “"preventing anaphylactic shock in asthma patients," (page 12, para 6). In response, both Cheng and Zhang are directed towards compositions that are delivered to a patient. Cheng’s cell preservation composition that also comprises cells is also intended for clinical use and direct injection into human body (Abstract). Zhang’s teachings are pertinent to Cheng because although Cheng uses compound amino acid injection in their composition that is intended to be delivered to patients, Zhang teaches regarding such compositions that amino acid solutions easily oxidize and sulfite added to such solutions to prevent oxidation is to known cause adverse reactions, such as “bronchospasm, asthma, dyspnea, nausea, laryngeal edema, hypotension, shock, and even death.” (page 2, para 6 and 7). Thus, indeed, in providing a sulfite-free amino-acid solution, Zhang is intended for preventing such adverse reactions including, as noted by the Applicant, “"preventing anaphylactic shock in asthma patients,". These teachings are pertinent to Cheng and thus, Cheng and Zhang are deemed analogous art. See MPEP 2141.01(a)(I). Next, regarding the combination of Zhang and Cheng, Application argue that since the compound amino acid injection of Cheng and Zhang comprise different number and type of amino acids, these are “mutually exclusive” and “serve different purposes” (page 13, para 1). In response, Applicant provide no evidence that compound amino acid injection that comprise different number or type of amino acids are “mutually exclusive” and “serve different purposes”. Further, Applicant provide no evidence that specific amino acid number and/or type is critical for the function of the claimed solution. To this end, the specification does not disclose the amino acid composition of the claimed “compound amino acid injection 14AA”, just the vendor source. The claimed cell preservation composition, in claims 3, 5-9, comprises compound amino acid injection 14AA but is not limited to any specific compound amino acid injection, such that additional amino acids could not be included. Artisans have used different compound amino acid injections in cell preservation solution. While Cheng lists 16 amino acids and L-glutamine (=17 total), Cheng states inclusion of essential and non-essential amino acids (Abstract). Ge (ref of record), also directed to cell preservation solution, lists all 18 amino acids ([0016, 0017]). Thus, there is no evidence of record that an ordinary artisan would consider compound amino acid injection with different number and type of amino acids as “mutually exclusive” and “serve different purposes” Regarding Cheng, Applicant argue that “There is no teaching or suggestion provided by Cheng to replace the cell preservation solution with the sulfite antioxidant free compound amino acid injection to improve the cell preservation.” (page 13, para 1). In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In the instant case, teaching, suggestion and motivation to replace the compound amino acid injection of Cheng with the sulfite antioxidant free compound amino acid injection of Zhang is provided by Zhang, not Cheng. Finally, Applicant conclude that “based on the aforementioned differences, people having ordinary skill in the art are not motivated to combine the teachings of Zhang into Cheng. Furthermore, based on the teaching of Cheng and even if the teaching of Zhang is referred, there is no motivation for people having ordinary skill in the art to replace the components of the cell preservation solution of Cheng with the sulfite antioxidant-free compound amino acid injection 14AA of Zhang” (page 13, para 2) In response, arguments presented above were unpersuasive. Zhang and Cheng are analogous art. Specific teachings from Zhang regarding oxidation of amino acids, adverse effects of sulfite-antioxidant and sulfite-free stable compound amino acid injection provide sufficient motivation to an ordinary artisan to combine teachings of Zhang and Cheng. Claims 3, 5-9 that are directed to cell preservation solution allow for inclusion of additional amino acids. Critically, any differences in the exact number or type of amino acids in a compound amino acid injection are not shown to be critical. Conclusion No claim is allowed. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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. Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATASHA DHAR whose telephone number is (571)272-1680. The examiner can normally be reached M-F 8am-4pm (EST). 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, Peter Paras Jr. can be reached at (571)272-4517. 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. /MATASHA DHAR/Examiner, Art Unit 1632 /EMILY A CORDAS/Primary Examiner, Art Unit 1632
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Prosecution Timeline

Nov 20, 2023
Application Filed
Feb 18, 2026
Non-Final Rejection mailed — §101, §103, §112
May 18, 2026
Response Filed
Jun 24, 2026
Final Rejection mailed — §101, §103, §112 (current)

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Prosecution Projections

3-4
Expected OA Rounds
44%
Grant Probability
94%
With Interview (+49.4%)
3y 8m (~1y 0m remaining)
Median Time to Grant
Moderate
PTA Risk
Based on 88 resolved cases by this examiner. Grant probability derived from career allowance rate.

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