DETAILED ACTION Claims 1-17 from the claim set filed March 6, 2026 are pending. Claims 13-17 are withdrawn. Thus, claims 1-12 are being examined on the merits herein. 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 1-12, drawn to a storage solution for packed red blood cells, in the reply filed March 6, 2026 is acknowledged. Thus, claims 13-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 1-12 will be examined on the merits herein. Priority A claim for benefit of a prior-filed application under 35 U.S.C. 119(a)-(f) or under 35 U.S.C. 120, 121, 365(a)-(c), 386 (a) or 386(c) has been made. The effective filing date of the present application is July 13, 2020. Information Disclosure Statement Examiner notes Applicant has not filed an Information Disclosure Statement. Claim Objections Claim 2 is objected to for comprising a typographical error. Claim 2 currently states: “wherein has a viscosity at…”. Examiner believes claim 2 should state: “wherein the storage solution has a viscosity at …”. 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. Claims 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over Chang (Chang et al., J Surg Res (2017) 212:54-59 ; PTO 892), in view of Wong (Wong et al., Scientific Reports (2016) 6(21023); PTO 892) and Huichao ( Huichao et al., Journal of Chemical and Pharmaceutical Research (2014) 6(5): 155-160; PTO 892), as evidenced by Pulliam (Pulliam et al., Surgery (2022) 171(3): 833-842; PTO 892). In regards to claims 1-6 , Chang teaches storage pH significantly affects the quality of stored red blood cells and cell survival following transfusion (Conclusion p1). Chang teaches as compared to pRBCs stored in standard AS3, those stored in alkaline solution (pH 8.5) (Methods p1) exhibited decreased hemolysis, phosphatidylserine externalization, microparticle production, and lipid peroxidation. Chang teaches lactate levels were greater following storage in alkaline conditions, suggesting that theses pRBCs remained more metabolically viable. As compared to standard AS3 storage, circulating half-life of cells was increased by alkaline storage (Results p1). Chang additionally teaches pRBCs were stored at 4 degrees Celsius (p3, 3 rd paragraph). Further, and as a POSITA will appreciate, the standard temperature for storing pRBCs is between 1-6 degrees Celsius. Thus, based on the teachings of Chang, a POSITA would have been motivated to store pRBCs at 4 degrees Celsius in an alkaline solution with a pH of 8.5 (i.e., claims 3 and 4) . Chang does not teach wherein the solution comprises 0.1% to 10% hydroxy-propyl-methyl-cellulose (HPMC) , which appears to be the concentration which provides the physical parameter of a viscosity at 4 degrees Celsius greater than about 20 millipascal seconds . Per the instant specification, the claimed storage solution for packed RBCs has from about 0.1 percent to about 10 percent of HPMC or about 1 to about 6 weight percent of HPMC [0032]. Thus, 0.1% to 10% HPMC or 1 to about 6 weight percent of HPMC inherently has a viscosity at 4 degrees Celsius greater than about 20 mPa.s or greater than about 50 mPa.s (i.e., claim 2 ). In addition, Pulliam evidences HPMC increases the viscosity of the solution (p5, 3 rd paragraph) and further evidences (Fig 1E and F; Table 1; p5, 3 rd paragraph) 1-2% (weight/volume) Hypromellose (i.e., HPMC) as a component of the EAS-1587 RBC storage solution corresponding with greater than 50 mPa.s at 4 degrees Celsius. Pulliam, Fig 1 Wong teaches the use of polymers to prevent blood settling ex vivo (Abstract). Wong teaches whole blood is typically processed into various components for specialized storage (Introduction 1 st paragraph). Wong teaches a fundamental aspect in the storage of this fluid tissue, blood cell settling, has been largely overlooked. This physical event alters cellular activities and leads to platelet aggregation and functional deterioration of leukocytes. Damaged cells are physically compacted in a confined space and liberate toxic byproducts that cross-activate each other, causing collateral damage to otherwise healthy cells. Wong teaches the ability to suspend blood in a homogeneous phase may therefore improve the preservation of WB ex vivo and facilitate the logistics of off-site or delayed processing of samples (Introduction 3 rd paragraph). Wong teaches a method to prevent sedimentation of WB in an attempt to improve the viable preservation of blood samples ex vivo. Wong teaches to stabilize materials in the fluid phase, they borrowed ideas from industrial products (i.e., shampoo and ketchup) that contain polymer additives (i.e., xantham gum, corn starch) as thickeners. These polymers prevent phase separation of the liquid components primarily through modifying rheological properties such as increasing the low shear viscosity. Wong teaches a similar strategy has been employed in the popular methylcellulose assay in which the semi-solid culture medium separates hematopoietic stem cells for the study of colony formation. Wong teaches to achieve suspended storage of blood, they chose the polysaccharide Ficoll , which is highly biocompatible due to its neutral charge and high hydrophilicity (Introduction 4 th paragraph). Wong teaches the polymer Ficoll stabilized blood samples and prevented blood settling, primarily by inhibiting depletion-mediated red blood cell aggregation (Abstract). Wong teaches the physical stabilization of blood through the use of the polymer Ficoll improved the preservation of RBCs. Wong additionally teaches in some applications (i.e., transfusions) it may be desirable to wash and resuspend blood cells in media or buffer. Wong therefore tested whether the presence of Ficoll is necessary to maintain RBC morphology. Wong found that the protective effect of Ficoll in preventing echinocyte formation post-storage (echinocyte formation is a sign of RBC aging) was still present after extensive washing with PBS. Suggesting that Ficoll improves the preservation of RBCs (Red blood cell preservation). Wong teaches for the first time that blood settling can be prevented using polymers and has implications in diagnostics. Thus a POSITA, when looking to the prior art, would have been motivated to store pRBCs in a biocompatible polymer solution, as the teachings of Wong show that RBCs are preserved when stabilized with such a solution. Thus, it would have been obvious, before the effective filing date of the claimed invention, to combine the teachings of Wong and Chang in order to have the optimum storage solution for packed RBCs in which said cells are in an alkaline solution stored at 4 degrees Celsius, as taught by Chang, and additionally said solution comprises a biocompatible polymer to improve the preservation of RBCs, as taught by Wong. Wong does not teach of a specific viscosity but rather teaches polymers prevent phase separation of liquid components primarily through modifying rheological properties such as increasing the low shear viscosity. Neither does Wong teach of 0.1% to 10% hydroxy-propyl-methyl-cellulose (HPMC). Huichao teaches of the application of the biomedical polymer material hydroxy propyl methyl cellulose (HPMC) in pharmaceutical preparations (Title). Huichao teaches HPMC is a hydrophilic gel matrix and bio-adhesion material that is widely used in pharmaceutical preparations. Huichao teaches HPMC’s popularity is attributed to its non-toxic nature, ease of compression, and capability to accommodate a high level of drug loading. Further, based on the difference of molecular weight and viscosity, HPMC is equipped with characteristics and application of emulsification, bonding, thickening and adhesion, suspension, gelation and film-forming (Introduction). Huichao additionally teaches one application of HPMC in pharmaceutical preparations is as a suspending agent. Huichao teaches higher-viscosity grades are used as a suspending agent in suspension type liquid formulations at levels of 0.5% - 1.5% w/w (p159, 3.8) (i.e., claims 5 and 6 ). As discussed supra, 0.1% to 10% HPMC or 1 to about 6 weight percent of HPMC inherently has a viscosity at 4 degrees Celsius greater than about 20 mPa.s or greater than about 50 mPa.s . Thus, it would have been obvious to a POSITA, before the effective filing date of the claimed invention, to do a simple substitution of one known element for another. It would have been obvious to substitute the biocompatible polymer Ficoll , as taught by Wong, for the biocompatible polymer HPMC, as taught by Huichao . The skilled artisan would have had a reasonable expectation of successfully substituting said biocompatible polymers due to both Wong and Huichao studying cell suspensions. Substitution of one element for another known in the field is considered to be obvious, absent a showing that the result of the substitution yields more than predictable results. See KSR International Co. v Teleflex Inc 82 USPQ2d 1385 (US 2007) at page 1395. Thus, the combination of Chang, Wong and Huichao , as evidenced by Pulliam, makes obvious claims 1-6. In regards to claim 7, the above cited references teach the storage solution of claim 5. The above cited references do not per se teach of 4% HPMC. As discussed supra , Huichao teaches higher-viscosity grades are used as a suspending agent in suspension type liquid formulations at levels of 0.5% - 1.5% w/w (p159, 3.8). Further, Huichao teaches one of the benefits of HPMC is that the viscosity is regulatory and thus can be changed as needed (p156, 2.4). Huichao additionally teaches of 2% HPMC being a satisfying suspending agent (p159, 3.8). Thus, Huichao teaches of 0.5%-2% HPMC concentrations. Moreover, Wong teaches of testing various concentrations of polymers in order to determine the percentage of polymer needed to achieve a desired blood settling concentration. Wong teaches of testing 0-15% concentrations of polymers (p4, Results, 1 st paragraph). Thus, Examiner notes the sole difference between the HPMC concentration of the instant application and the prior art comprises only the routine optimization of HPMC concentration. Said optimization would have been obvious and well within the purview of the ordinarily skilled artisan at the time of filing. A POSITA would have been motivated to modify the concentration of HPMC to optimize for blood settling and to thus achieve optimal storage performance of RBCs. As a POSITA will appreciate, HPMC concentration is a result effective variable based on multiple parameters such as volume size, time spent in culture, cell density, culture composition, etc. Absent any teaching of criticality or unexpected results by the Applicant, it would be obvious that one of ordinary skill in the art would recognize that HPMC concentration is a result effective variable and Examiner notes that the optimization of HPMC concentration would have been prima facie obvious to one of ordinary skill in the art at the time of filing. Generally, differences in parameters will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such parameter 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). Thus, the claim is obvious and is properly rejected. In regards to claim 8 , the above cited references teach the storage solution of claim 5. Further, Chang teaches a popular inclusion in experimental additive solutions is sodium bicarbonate (p5, last paragraph-p6, top of the page). Thus, the claim is obvious. Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Chang (Chang et al., J Surg Res (2017) 212:54-59; PTO 892), in view of Wong (Wong et al., Scientific Reports (2016) 6(21023); PTO 892) and Huichao ( Huichao et al., Journal of Chemical and Pharmaceutical Research (2014) 6(5): 155-160; PTO 892), as evidenced by Pulliam (Pulliam et al., Surgery (2022) 171(3): 833-842; PTO 892) and further in view of Hess (US 6,447,987 B1, published Sept 10, 2002, cited in the Incoming Written Opinion of the International Searching Authority, filed 1/9/2023; PTO 892). In regards to claim 12, the above cited references teach the storage solution of claim 1. The above cited references do not teach the required concentrations of the storage solution as cited in claim 12. Hess teaches of novel additive solutions useful for the storage of human RBCs (Abstract). Hess teaches of preserving RBCs at about 1 to 6 degrees Celsius and further teaches the additive solutions allow for viable storage of human RBCs for an extended period of time in a solution which is directly infusible in humans (Abstract). Hess teaches said solution contains adenine, dextrose, sodium phosphate (Na2HPO4), and at least one physiologically acceptable sodium salt in amounts sufficient to preserve RBCs which amount includes a buffering amount of sodium bicarbonate and/or sodium citrate (trisodium citrate) to maintain the pH at or above about 8, preferably at about 8.4 (column 2, lines 62-57 – column 3, lines 1-3) ( claims 10 and 11 ). Hess additionally teaches the addition of sodium chloride to said solution (column 4, line 20). In regards to specific concentrations, Hess teaches said solution contains: adenine from about 1 to 3 mM, dextrose from about 20 to 115 mM, sodium phosphate from about 4 to 15mM, at least one physiologically acceptable sodium salt from about 20 to 130 mM, and 10-30 mM of sodium bicarbonate (column 4, lines 1-16). In regards more specifically to the “at least one physiologically acceptable sodium salt”, Hess teaches preferred sodium salts include sodium chloride, sodium citrate and the like from about 20 to 130 mM. Hess further teaches preferably, the solution contains about 20 to 100 mM of sodium chloride (column 4, lines 1-25). Examiner respectfully notes the claimed ranges overlap with the teachings of Hess. 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). MPEP 2144.05 Thus, a POSITA would have been motivated and it would have been obvious, before the effective filing date of the claimed invention, to combine the teachings of Chang, Wong and Huichao with the teachings of Hess in order to have a solution allowing for viable storage of human RBCs for an extended period of time in a solution which is directly infusible in humans. As all the above cited references teach of storing RBCs, a POSITA would thus have had a reasonable expectation of success in combining said teachings. Hess and the above cited references do not teach of 4% HPMC. As discussed supra , Huichao teaches higher-viscosity grades are used as a suspending agent in suspension type liquid formulations at levels of 0.5% - 1.5% w/w (p159, 3.8). Further, Huichao teaches one of the benefits of HPMC is that the viscosity is regulatory and thus can be changed as needed (p156, 2.4). Huichao additionally teaches of 2% HPMC being a satisfying suspending agent (p159, 3.8). Thus, Huichao teaches of 0.5%-2% HPMC concentrations. Moreover, Wong teaches of testing various concentrations of polymers in order to determine the percentage of polymer needed to achieve a desired blood settling concentration. Wong teaches of testing 0-15% concentrations of polymers (p4, Results, 1 st paragraph). Thus, Examiner notes the sole difference between the HPMC concentration of the instant application and the prior art comprises only the routine optimization of HPMC concentration. Said optimization would have been obvious and well within the purview of the ordinarily skilled artisan at the time of filing. A POSITA would have been motivated to modify the concentration of HPMC to optimize for blood settling and to thus achieve optimal storage performance of RBCs. As a POSITA will appreciate, HPMC concentration is a result effective variable based on multiple parameters such as volume size, time spent in culture, cell density, culture composition, etc. Absent any teaching of criticality or unexpected results by the Applicant, it would be obvious that one of ordinary skill in the art would recognize that HPMC concentration is a result effective variable and Examiner notes that the optimization of HPMC concentration would have been prima facie obvious to one of ordinary skill in the art at the time of filing. Generally, differences in parameters will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such parameter 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). Thus, the claim is obvious and is properly rejected. Claims 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Hess (US 6,447,987 B1, published Sept 10, 2002, cited in the Incoming Written Opinion of the International Searching Authority, filed 1/9/2023; PTO 892), in view of Wong (Wong et al., Scientific Reports (2016) 6(21023); PTO 892) and Huichao ( Huichao et al., Journal of Chemical and Pharmaceutical Research (2014) 6(5): 155-160; PTO 892). In regards to claims 9-11 , Hess teaches of novel additive solutions useful for the storage of human RBCs (Abstract). Hess teaches of preserving RBCs at about 1 to 6 degrees Celsius and further teaches the additive solutions allow for viable storage of human RBCs for an extended period of time in a solution which is directly infusible in humans (Abstract). Hess teaches said solution contains adenine, dextrose, sodium phosphate (Na2HPO4), and at least one physiologically acceptable sodium salt in amounts sufficient to preserve RBCs which amount includes a buffering amount of sodium bicarbonate and/or sodium citrate (trisodium citrate) to maintain the pH at or above about 8, preferably at about 8.4 (column 2, lines 62-57 – column 3, lines 1-3) ( claims 10 and 11 ). Hess additionally teaches the addition of sodium chloride to said solution (column 4, line 20). In regards to specific concentrations, Hess teaches said solution contains: adenine from about 1 to 3 mM, dextrose from about 20 to 115 mM, sodium phosphate from about 4 to 15mM, at least one physiologically acceptable sodium salt from about 20 to 130 mM, and 10-30 mM of sodium bicarbonate (column 4, lines 1-16). In regards more specifically to the “at least one physiologically acceptable sodium salt”, Hess teaches preferred sodium salts include sodium chloride, sodium citrate and the like from about 20 to 130 mM. Hess further teaches preferably, the solution contains about 20 to 100 mM of sodium chloride (column 4, lines 1-25). Examiner respectfully notes the claimed ranges overlap with the teachings of Hess. 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). MPEP 2144.05 Hess does not teach of HPMC. As discussed supra in regards to claim 1, Wong teaches the use of polymers to prevent blood settling ex vivo (Abstract). Wong teaches whole blood is typically processed into various components for specialized storage (Introduction 1 st paragraph). Wong teaches a fundamental aspect in the storage of this fluid tissue, blood cell settling, has been largely overlooked. This physical event alters cellular activities and leads to platelet aggregation and functional deterioration of leukocytes. Damaged cells are physically compacted in a confined space and liberate toxic byproducts that cross-activate each other, causing collateral damage to otherwise healthy cells. Wong teaches the ability to suspend blood in a homogeneous phase may therefore improve the preservation of WB ex vivo and facilitate the logistics of off-site or delayed processing of samples (Introduction 3 rd paragraph). Wong teaches a method to prevent sedimentation of WB in an attempt to improve the viable preservation of blood samples ex vivo. Wong teaches to stabilize materials in the fluid phase, they borrowed ideas from industrial products (i.e., shampoo and ketchup) that contain polymer additives (i.e., xantham gum, corn starch) as thickeners. These polymers prevent phase separation of the liquid components primarily through modifying rheological properties such as increasing the low shear viscosity. Wong teaches a similar strategy has been employed in the popular methylcellulose assay in which the semi-solid culture medium separates hematopoietic stem cells for the study of colony formation. Wong teaches to achieve suspended storage of blood, they chose the polysaccharide Ficoll , which is highly biocompatible due to its neutral charge and high hydrophilicity (Introduction 4 th paragraph). Wong teaches the polymer Ficoll stabilized blood samples and prevented blood settling, primarily by inhibiting depletion-mediated red blood cell aggregation (Abstract). Wong teaches the physical stabilization of blood through the use of the polymer Ficoll improved the preservation of RBCs. Wong additionally teaches in some applications (i.e., transfusions) it may be desirable to wash and resuspend blood cells in media or buffer. Wong therefore tested whether the presence of Ficoll is necessary to maintain RBC morphology. Wong found that the protective effect of Ficoll in preventing echinocyte formation post-storage (echinocyte formation is a sign of RBC aging) was still present after extensive washing with PBS. Suggesting that Ficoll improves the preservation of RBCs (Red blood cell preservation). Wong teaches for the first time that blood settling can be prevented using polymers and has implications in diagnostics. Thus a POSITA, when looking to the prior art, would have been motivated to store pRBCs in a biocompatible polymer solution, as the teachings of Wong show that RBCs are preserved when stabilized with such a solution. Thus, it would have been obvious, before the effective filing date of the claimed invention, to combine the teachings of Wong and Hess in order to have the optimum storage solution for packed RBCs in which said cells are in an additive solution of about 8.4, in which said additive solutions allow for viable storage of human RBCs for an extended period of time in a solution which is directly infusible in humans, as taught by Hess, and additionally said solution comprises a biocompatible polymer to improve the preservation of RBCs, as taught by Wong. Wong does not teach of a specific viscosity but rather teaches polymers prevent phase separation of liquid components primarily through modifying rheological properties such as increasing the low shear viscosity. Neither does Wong teach of 0.1% to 10% hydroxy-propyl-methyl-cellulose (HPMC). Huichao teaches of the application of the biomedical polymer material hydroxy propyl methyl cellulose (HPMC) in pharmaceutical preparations (Title). Huichao teaches HPMC is a hydrophilic gel matrix and bio-adhesion material that is widely used in pharmaceutical preparations. Huichao teaches HPMC’s popularity is attributed to its non-toxic nature, ease of compression, and capability to accommodate a high level of drug loading. Further, based on the difference of molecular weight and viscosity, HPMC is equipped with characteristics and application of emulsification, bonding, thickening and adhesion, suspension, gelation and film-forming (Introduction). Huichao additionally teaches one application of HPMC in pharmaceutical preparations is as a suspending agent. Huichao teaches higher-viscosity grades are used as a suspending agent in suspension type liquid formulations at levels of 0.5% - 1.5% w/w (i.e., 0.5 to 1.5 weight percent) (p159, 3.8). Thus, it would have been obvious to a POSITA, before the effective filing date of the claimed invention, to do a simple substitution of one known element for another. It would have been obvious to substitute the biocompatible polymer Ficoll , as taught by Wong, for the biocompatible polymer HPMC, as taught by Huichao . The skilled artisan would have had a reasonable expectation of successfully substituting said biocompatible polymers due to both Wong and Huichao studying cell suspensions. Substitution of one element for another known in the field is considered to be obvious, absent a showing that the result of the substitution yields more than predictable results. See KSR International Co. v Teleflex Inc 82 USPQ2d 1385 (US 2007) at page 1395. Thus, the combination of Hess, Wong and Huichao makes obvious claims 9-11. Conclusion No claims are allowable. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT KATHERINE R SMALL whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (703)756-4783 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Monday - Friday 8:30am-4pm . 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, FILLIN "SPE Name?" \* MERGEFORMAT Chris Babic can be reached on FILLIN "SPE Phone?" \* MERGEFORMAT 571-272-8507 . 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. /KATHERINE R SMALL/ Examiner, Art Unit 1633 /EVELYN Y PYLA/ Primary Examiner, Art Unit 1633