DETAILED ACTION
Status of claim rejections
The rejection under 35 USC 103 is maintained and modified in view of Applicant’s arguments/amendments in the response filed 03/18/2026.
This Action is FINAL.
Modified 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.
First rejection
Claims 27, 38, and 41-43 are rejected under 35 U.S.C. 103 as being unpatentable over Oyama et al (WO 2018097226 A1, 31 May 2018; cited with English machine translation in applicant 10 Nov 2021 IDS; prior art of record; hereinafter “Oyama”), and further in view of Licari et al (US20070087320A1; hereinafter “Licari”; prior art of record), Stowell et al. ((2013), Ascorbic Acid Improves Mouse RBC Storage. Transfusion, 53: 2248-2257), Hirose et al (WO2017065280A1; 20 April 2017; cited in Applicant’s 11/10/21 IDS; prior art of record; hereinafter “Hirose”) and Lee et al (Cryobiology Volume 50, Issue 1, February 2005, Pages 103-111; cited in Applicant 12/13/22; prior art of record; hereinafter “Lee”).
Oyama teaches a preservative solution for live cells or composition comprising live cells (title). Oyama teaches a method of preserving a sheet-like cell culture comprising immersing a sheet-like cell culture in a preservative solution (a method for preserving a cell in a liquid as in claim 27), where the solution of Oyama comprises synthetic vitamins in a physiological isotonic solution (see claims 1 and 7 of Oyama). Oyama also teaches that the vitamins include niacin/vitamin B3 and/or its derivatives (paragraph 0034) (as in claim 27) and other vitamins such as vitamin A, vitamin B1, vitamin B2, vitamin B5, vitamin C, vitamin E etc. (vitamin C/ascorbic acid as in claim 27) (paragraph 0034-0040). The cell(s) preserved can include living cells, such as myoblasts, mesenchymal stem cells, myocardial cells, fibroblasts, etc. (paragraph 0019). Oyama also teaches that the preservation solution can contain vitamin C as an essential vitamin in combination with an optional vitamin such as vitamin B3 (i.e., niacin) only (paragraph 0049). Thus, Oyama teaches a solution that does not comprise vitamin B2 or a derivative thereof or a salt thereof. Oyama further teaches that the temperature conditions during storage can be anywhere between 2-40 degrees Celsius (between 0 and 40 deg C as in claim 27; paragraph 0136) and that the cell culture can be stored anywhere between 4-200 hours (200 hours = approx. 8 days; between 1-15 days as in claim 27; see paragraph 0138).
The difference between Oyama and the instant claims is that Oyama does not explicitly teach that the solution comprises 390-1200 mg/L of niacin, a derivative of niacin, or a salt of niacin, or a salt of the derivative of niacin.
However, Licari teaches preservation solutions for living tissues, organs, and cells (see title, abstract, claim 1). Licari specifically teaches that the preservation medium contains independently or in combination: from 0.01 to 350 mg/l of vitamins necessary for the maintenance of cells and tissues, including nicotinamide (i.e., vitamin B3; a derivative of niacin as in claim 27) (see paragraphs 0036-40). Please note that Licari teaches amounts of vitamins, including nicotinamide at 350 mg/L, which is close to Applicant’s range of 390 mg/L. A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) (see MPEP 2144.05(I)).
Therefore, it would have been prima facie obvious to one of ordinary skill at the time of filing to modify the cell preservation solution of Oyama by including the concentration of nicotinamide as taught by Licari to arrive at the claimed invention. As Oyama teaches a preservative solution for live cells including niacin (vitamin B3) and Licari teaches a suitable concentration of nicotinamide (a derivative of niacin) that can be used in a medium to promote preservation of living cells, one of ordinary skill would have been motivated to make the modification with a reasonable expectation of success. One of ordinary skill to make the modification because Licari teaches that nicotinamide can advantageously be utilized in a cell medium necessary for the maintenance of cells and tissues.
Oyama and Licari do not teach the solution comprises 900-3000 mg/L of ascorbic acid.
However, Stonewall (in a similar field of endeavor of cell storage solutions) teaches addition of ascorbic acid solutions to stored murine RBCs to improve the quality of the stored cells (see title, abstract). Stonewall specifically teaches adding concentrations of ascorbic acid to storage solutions, where the final concentrations of ascorbic acid in the storage solutions were 0.63 mg/mL (which is 693 mg/L), 1.27 mg/mL (which is 1270 mg/L), 1.90 mg/mL (which is 1900 mg/L), and 12.69 mg/mL (which is 12,690 mg/L) (see pg. 2250, col 1; see Fig. 1; Fig. 3). Please note that 1270 mg/L and 1900 mg/L fall within Applicant’s claimed range of 900-3000 mg/L. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (see MPEP 2144.05(I)). Stonewall further teaches various benefits of ascorbic acid as an antioxidant in storage solutions, including that ascorbic acid represents one of the most well-studied naturally occurring antioxidants, can significantly reduce cellular oxidation, enhance cellular viability and improving cellular function (of non-RBC populations) (see pg. 255, col 2).
Therefore, it would have been prima facie obvious to one of ordinary skill at the time of filing to modify the cell preservation solution of Oyama and Licari by using the concentration of ascorbic acid as taught by Stonewall to arrive at the claimed invention. One of ordinary skill would have been motivated to make the modification because Stonewall explicitly teaches ascorbic acid’s ability to improve quality of stored cells and various benefits of ascorbic acid as an antioxidant in storage solutions, ability to significantly reduce cellular oxidation, enhance cellular viability and improving cellular function of non-RBC populations.
Oyama, Licari, and Stonewall do not teach that the cell is a platelet or megakaryocyte.
However, Hirose teaches a method for producing purified platelets (title, abstract). Hirose teaches that the platelets (the cell is a platelet as in claim 27) are produced from megakaryocyte cells (the cell is a megakaryocyte as in claim 27) cultured in vitro (pg. 2, paragraph 2). Hirose also teaches that when the megakaryocytes are cultured in vitro to produce platelets, it is necessary to separate and concentrate the platelets from the megakaryocytes (pg. 2, paragraph 4). Hirose also teaches that to separate and concentrate the platelets, a cell sorter cannot be used and centrifugation using a filter or hollow fiber membrane causes loss of platelet physiological activity and a recovery rate as low as 10% (pg. 2, paragraph 4). Hirose also teaches the use of a centrifugation step where the culture of megakaryocytes is centrifuged using a centrifugal force of 150 x g to 550 x g and a second centrifugation step of centrifuging the liquid component recovered in the first centrifugation step with a centrifugal force of 600 × g to 4000 × g (pg. 1, claim 1). Hirose teaches that the high-quality platelets can be purified from a megakaryocyte culture in a large amount at a high recovery rate, so that a large amount of safe platelet preparations with low risk of bacterial contamination can be obtained (pg. 2, paragraph 8; pg. 6; Example 3). Hirose further teaches that the purified platelets can be added to the megakaryocyte culture or after the centrifugation steps (pg. 3, paragraph 3; paragraph 8).
Therefore, it would have been prima facie obvious to one of ordinary skill at the time of filing to modify the method of preserving cells as taught by Oyama, Licari, and Stonewall by preserving a platelet or megakaryocyte cell as taught by Hirose to arrive at the claimed invention. As the claimed invention relies on the preservation of mammalian cells using a preservation solution, one of ordinary skill would have been motivated to perform a simple substitution of one known element (the mammalian cells of Oyama, Licari, and Stonewall) for another (the platelet or megakaryocyte of Hirose) with a reasonable expectation of success (preserving a mammalian cell using a preservation solution). One of ordinary skill would have been motivated to make the substitution because Hirose teaches the successful purification of platelets from megakaryocytes, where the megakaryocytes/platelets are preserved in a preservation solution.
The difference between the references and the instant claim is that none of the references explicitly teach the liquid further comprises 1.25-7.25% albumin.
However, Lee teaches the effect of human serum albumin on the extended storage of human oral keratinocyte viability under mild hypothermia (title). Lee teaches that cell suspensions of oral keratinocytes in saline or DMEM supplemented with 10% albumin (albumin as in claim 27) showed higher viability after 24 and 72 h at 4 degrees Celsius in comparison to keratinocytes stored in saline or DMEM alone (pg. 106, col 1, paragraph 1; pg. 106; Fig. 1; pg. 107; Fig. 2). Lee further teaches that albumin has a lot of functions, including acting as a chelator, binding growth factors, antioxidant properties, and caused improved cell viability and stability (pg. 109, col 1-2).
Note that Lee teaches use of 10% albumin outside of Applicant’s range of 1.25-7.25%. However, generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (see MPEP 2144.05(II)). Furthermore, the amount of albumin used for storage of cells would have been a matter of routine experimentation using standard laboratory techniques available at the time of filing (see MPEP 2144.05(II) because Lee explicitly teaches various advantages of using albumin, such as acting as a chelator, binding growth factors, antioxidant properties, and caused improved cell viability and stability.
Therefore, it would have been prima facie obvious to one of ordinary skill at the time of filing to modify the method of preserving cells as taught by Oyama, Licari, Stonewall, and Hirose by including albumin in the preservation solution as taught by Lee to arrive at the claimed invention. As Lee teaches the effect of albumin on extended storage of keratinocyte cells, one of ordinary skill would have been motivated to add albumin to the solution of Oyama and Hirose with a reasonable expectation of success. One of ordinary skill would have been motivated to make the modification because Lee teaches that albumin advantageously is capable of causing improved cell viability and stability due to its chelating and antioxidant properties.
Regarding claim 38, Hirose also teaches that when the megakaryocytes are cultured in vitro to produce platelets, it is necessary to separate and concentrate the platelets from the megakaryocytes (a condensation step of condensing a culture product of megakaryocytes as in claim 38, step (A)) (pg. 2, paragraph 4) and the use of a centrifugation step where the culture of megakaryocytes is centrifuged using a centrifugal force of 150 x g to 550 x g and a second centrifugation step of centrifuging the liquid component recovered in the first centrifugation step with a centrifugal force of 600 × g to 4000 × g (pg. 1, claim 1). (as in claim 38, step (B)). As such, it also would have been prima facie obvious to one of ordinary skill to modify the method of preserving cells by including the concentration and centrifugation steps as taught by Hirose to arrive at the claimed invention. As Oyama teaches a method of preserving cells using a niacin and antioxidant solution, and Hirose teaches the production of purified platelets using a centrifugation and concentration step from megakaryocytes, one of ordinary skill would have been motivated to include the purification protocol with a reasonable expectation of success. One of ordinary skill would have been motivated to include the protocol because Hirose teaches the successful preparation of high-quality platelets from a megakaryocyte culture at a high recovery rate that advantageously has low risk of bacterial contamination.
Regarding claims 41-42, Oyama teaches that the preservation solution can include sugar, where the sugar is various concentrations of glucose (paragraph 0154).
Regarding claim 43, Oyama teaches that the cells can be preserved anywhere between 4-200 hours (200 hours = approx. 8 days) (paragraph 0138) and Hirose teaches the cell to be preserved can be a platelet or megakaryocyte (see above).
Accordingly, the claimed invention was prima facie obvious at the time of filing, especially in the absence of evidence to the contrary.
Second rejection
Claims 44-46, 48 and 50 are rejected under 35 U.S.C. 103 as being unpatentable over Oyama, Licari, Stonewall, and further in view of Nishimura et al (US 20160120170; 05 May 2016; cited in Applicant 11/10/21 IDS; prior art of record; hereinafter “Nishimura”).
As discussed above, Oyama teaches a preservative solution for live cells, including mesenchymal stem cells (see above, stem cell as in claim 44; mesenchymal stem cell as in claim 45) comprising ascorbic acid and vitamin B3 (i.e., niacin) where temperature conditions during storage can be anywhere between 2-40 degrees Celsius (between 0 and 40 deg C as in claim 44; paragraph 0136) and that the cell culture can be stored anywhere between 4-200 hours (200 hours = approx. 8 days; between 1 and 63 days as in claim 44).
Also as discussed above, Licari teaches a preservation medium that contains from 0.01 to 350 mg/l of vitamins necessary for the maintenance of cells and tissues, including nicotinamide (i.e., vitamin B3; a derivative of niacin (as in claim 44).
As further discussed above, Stonewall teaches use of 1270 mg/L and 1900 mg/L of ascorbic acid (as in claim 44) for, e.g., reducing cellular oxidation, enhancing cellular viability and improving cellular function of non-RBC populations.
The difference between the references and the instant claims, is that none of the references explicitly teach that the solution has trehalose in an isotonic solution.
However, Nishimura teaches trehalose and dextran-containing solution for transplanting mammalian cells (title). Nishimura teaches a method of preserving a mammalian cell in an aqueous solution comprising 2-6% (w/v) of trehalose, lactate Ringer’s solution, and 4-7% (w/v) of dextran (the isotonic solution comprises trehalose as in claim 44; lactate Ringer’s as in claim 48; dextran as in claim 50) (see claim 1 and 6 of Nishimura). Nishimura also teaches that the mammalian cell to be preserved can be a mammalian T cell, such as human peripheral blood T cells, leukocytes, T cells, helper T cells, cytotoxic T cells, and γδ cells (the immunocyte is a T cell as in claim 46) (see claims 4, 8, and 9 of Nishimura; paragraph 0045). Nishimura teaches that trehalose has the properties of stabilizing cell membrane and suppressing cell damage (paragraph 0004), and a physiological aqueous solution containing dextran or trehalose can suppress the cell death and can increase the percentage of living cells (paragraph 0074-0075).
Therefore, it would have been prima facie obvious to one of ordinary skill at the time of filing to modify the method of preserving cells as taught by Oyama, Licari, and Stonewall by including dextran, trehalose, and lactate Ringer’s solution in the preservation solution to arrive at the claimed invention. As Nishimura teaches the preservation of mammalian cells in a solution that has dextran, trehalose, and lactate Ringer’s, one of ordinary skill would have been motivated to include dextran, trehalose, and lactate Ringer’s in the solution with reasonable expectation of success. One of ordinary skill would have been motivated to make the modification because Nishimura teaches that trehalose advantageously has the properties of stabilizing cell membrane and suppressing cell damage, and solutions containing dextran, trehalose, and lactate Ringer’s can suppress the cell death and can increase the percentage of living cells.
It also would have been prima facie obvious to preserve a T cell as taught by Nishimura to arrive at the claimed invention. As the claimed invention relies on the preservation of mammalian cells using a preservation solution, one of ordinary skill would have been motivated to perform a simple substitution of one known element (the mammalian cells of Oyama, Licari, and Stonewall) for another (the T cell of Nishimura) with a reasonable expectation of success (preserving a mammalian cell using a preservation solution). One of ordinary skill would have been motivated to make the substitution because Nishimura teaches that mammalian T cells can successfully preserved in a solution that has trehalose, dextran, and Ringer’s lactate solution.
Accordingly, the claimed invention was prima facie obvious at the time of filing, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant's arguments filed 03/18/2026 have been fully considered but they are not persuasive.
Applicant’s arguments with respect to the Thatte reference have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
On pg. 5-8 of the remarks, Applicant argues that the examiner’s understanding of the Licari reference incorrect (citing to paragraphs 0040-54) to argue that Licari does not disclose a specific solution including both ascorbic acid and nicotinamide but is rather a menu from which a PHOSITA may select vitamins including tocopherol acetate, retinol acetate, hydroquinone, and so forth. Applicant argues that even though the paragraphs “would include an embodiment which includes both ascorbic acid and nicotinamide”, it would also include dozens of other possible combinations of vitamins. Applicant also argues the medium of Licari does not require vitamins and B3 as an essential component and has not been specifically confirmed in the examples as having an effect as a preservation medium and only shows the possibility of using vitamin B3. Applicant then argues that a PHOSITA would not consider 0.01-350 mg/L of vitamins to be the optimum concentration as Licari discloses in examples 1-7 comprises “vitamins” at 163 mg/L, doesn’t describe the vitamin as niacin, does not consider its effects would be present even when a vitamin is used at a different concentration, and only discloses a non-overlapping range of 0.01-350 mg/L nicotinamide.
In response the examiner disagrees. First, Licari specifically discloses “In a particularly advantageous way, the preservation medium according to the invention contains independently or in combination: from 0.01 to 350 mg/l of vitamins, preferably selected from among: tocopherol acetate, retinol acetate, hydroquinone, ascorbic acid, thiamin B1-HCL, riboflavin B2, calcium D-pantothenate B5, pyridoxal HCl B6, biotin B8, folic acid B9, cyancobalamine B12, nicotinamide B3 PP, chromium orotate B13” (see paragraph 0040). Second, as Applicant concedes above, the disclosure of Licari would include embodiments having both ascorbic acid and nicotinamide as part of the solution. Arguendo, even if the listing of Licari is a “menu” from which a PHOSITA could choose from as instantly argued, a PHOSITA would simply be choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success (see MPEP 2143). An obviousness rejection under 35 USC 103 requires the prior art to provide a teaching, suggestion, and/or motivation regarding the use of the same components as instantly claimed, which Licari provides as discussed above.
Third, regarding Applicant’s arguments regarding Licari only discloses the solution “comprises “vitamins” at 163 mg/L doesn’t describe the vitamin as niacin, does not consider its effects would be present even when a vitamin is used at a different concentration, and only discloses a non-overlapping range of 0.01-350 mg/L nicotinamide”, “[a] reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Labs., Inc. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989). See also Upsher-Smith Labs. v. Pamlab, LLC, 412 F.3d 1319, 1323, 75 USPQ2d 1213, 1215 (Fed. Cir. 2005). The 163 mg/L as disclosed by Licari is merely one embodiment of the disclosure. This does not discount that Licari explicitly discloses that the vitamin can be used at concentrations including 350 mg/L, which is close to Applicant’s range of 390 mg/L. A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) (see MPEP 2144.05(I)).
On pg. 8-10, Applicant argues that Thatte only discloses a non-overlapping range of 10-500 mg/L of ascorbic acid. Applicant’s arguments with respect to the Thatte reference have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Further, the newly cited Stonewall reference explicitly teaches 1270 mg/L and 1900 mg/L fall within Applicant’s claimed range of 900-3000 mg/L. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (see MPEP 2144.05(I)). Applicant then argues the amount of albumin as taught by Lee, which only discloses 10% albumin and the claimed 1.25-7.25% albumin would not be obvious. Applicant further argues the rejection of the dependent claims using the Nishimura reference for the same reasons as set forth above.
In response, the examiner disagrees. Regarding the range of albumin as taught by Lee, the examiner notes that Lee teaches use of 10% albumin outside of Applicant’s range of 1.25-7.25%. However, generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (see MPEP 2144.05(II)). Furthermore, the amount of albumin used for storage of cells would have been a matter of routine experimentation using standard laboratory techniques available at the time of filing (see MPEP 2144.05(II) because Lee explicitly teaches various advantages of using albumin, such as acting as a chelator, binding growth factors, antioxidant properties, and caused improved cell viability and stability. In combination, all of the references render the claims prima facie obvious for the reasons set forth above, which includes the dependent claims using the Nishimura reference. Thus, the rejection are maintained/modified as set forth above.
Conclusion
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.
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/G.C.R./Examiner, Art Unit 1651
/THOMAS J. VISONE/Supervisory Patent Examiner, Art Unit 1672
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