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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/09/2025 has been entered.
Status of the Clams
Claims 35-46, 48-53, and 89-92 are pending.
Claims 35-46, 48-53, and 89-91 are newly amended.
Claims 35-46, 48-53, and 89-92 are under examination on their merits.
Withdrawn Objections & Rejections
The objections and rejections presented herein represent the full set of objections and rejections currently pending in the application. Any objections or rejections not specifically reiterated are hereby withdrawn.
The rejection of claims 35-46, 48-53, and 89-91 under 35 U.S.C. 102(a)(1) or 35 U.S.C. 102(a)(2) as being anticipated by Yoshida et al. (US20120225416A1, on IDS 04/27/2021, hereafter “Yoshida 2012”, previously cited) as evidenced by Oxford Languages (retrieved from internet 03/31/2025, previously cited), Blood Bank Guy (retrieved from internet 03/31/2025, previously cited), Severinghaus (Journal of Applied Physiology, 46(3): 599-602, 1979, previously cited), Sharma et al. (Asian J Tranf Sci, 2010, previously cited) and Meyer et al. (Blood Complications, 2011) is withdrawn to address the claim amendments.
The rejection of claim 92 is rejected under 35 U.S.C. 103 as being unpatentable over Yoshida et al. (US20120225416A1, on IDS 04/27/2021, hereafter “Yoshida 2012”) in view of view of Masse (Transfus Clin Biol, 2001), as evidenced by Oxford Languages (retrieved from internet 03/31/2025), Blood Bank Guy (retrieved from internet 03/31/2025), Severinghaus (Journal of Applied Physiology, 46(3): 599-602, 1979, previously cited), and Meyer et al. (Blood Complications, 2011) is withdrawn to address the claim amendments.
Claim Interpretation
Claim 1 recites the term “stored” as in a “stored oxygen and carbon dioxide reduced leukoreduced whole blood composition.”
The specification does not define this term.
As understood in the art, as defined by Oxford Languages (retrieved from internet 03/31/2025, previously cited), the verb “store” means “[To] keep or accumulate (something) for future use.”
Thus, giving the term its broadest reasonable interpretation in view of the disclosure and the art, the “stored” blood composition has been interpreted as any oxygen and carbon dioxide reduced leukoreduced whole blood that has been kept or accumulated for future use.
It is noted that the timing of the storage is unlimited in the claims and may be stored for any amount of time.
Claim 1 also recites the term “leukoreduced” which is not specifically defined in the specification.
As evidenced by Blood Bank Guy (retrieved from internet 03/31/2025, previously cited), as understood in the art, leukocyte reduction (leukoreduction), is the process of removing white blood cells from a blood product prior to transfusion.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 49-50 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 49 contains the trademark/trade name “TEG”. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a parameter in a specific viscoelastic hemostatic assay and, accordingly, the identification/description is indefinite.
Referring to instances of TEG in the claim as “thromboelastography” (e.g., “thromboelastography angle” in line 5, etc.) would be ameliorative.
Claim 50 is rejected under 35 USC 112(b) for its dependence on claim 49.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 35-40, 53, and 89-91 are rejected under 35 U.S.C. 102(a)(1) or 35 U.S.C. 102(a)(2) as being anticipated by Yoshida et al. (US20120225416A1, on IDS 04/27/2021, hereafter “Yoshida 2012”, previously cited) as evidenced by Severinghaus (Journal of Applied Physiology, 46(3): 599-602, 1979, previously cited).
Claims 35, 41-46, and 48-52 are rejected under 35 U.S.C. 102(a)(1) or 35 U.S.C. 102(a)(2) as being anticipated by Yoshida et al. (US20120225416A1, on IDS 04/27/2021, hereafter “Yoshida 2012”, previously cited) as evidenced by Severinghaus (Journal of Applied Physiology, 46(3): 599-602, 1979, previously cited) and Sharma et al. (Asian J Tranf Sci, 2010, previously cited).
In regards to claims 35-39, and 89-90, as newly amended, the claim is drawn to a “stored oxygen and carbon dioxide reduced leukoreduced whole blood composition for transfusion to a trauma patient in need of multiple transfusion.”
While the claims are drawn to a product (a composition), storing that product is a process step. Thus, claim 35 is a product-by-process claim.
In regards to product-by-process claims, according to MPEP 2113, that while the structure implied by the process steps should be considered when assessing the patentability of product-by-process claims over the prior art, especially where the product can only be defined by the process steps by which the product is made, or where the manufacturing process steps would be expected to impart distinctive structural characteristics to the final product. See, e.g., In re Garnero, 412 F.2d 276, 279, 162 USPQ 221, 223 (CCPA 1979), and that the claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
It is further noted that the only process steps are storing, leukoreducing, and oxygen and carbon dioxide reducing whole blood.
As defined above, the process step of storing only refers to keeping or accumulating the blood for future use. It is not limited to any particular amount of time nor storage methods. Thus, whole blood in a collection bag after leukapheresis would still reads on this limitation. Additionally, the claim could read on simply collecting blood in vials directly from a patient (donor) because the timing in which the storing occurs is not defined the claims and therefore, blood drawn from a patient in vials (stored) and subsequently leukoreduced is still stored leukoreduced whole blood. Additionally, the level of leukoreduction is not defined, and therefore, the whole may still have some level of white blood cells.
Therefore, the claim does not include process steps where the product can only be defined by the process steps by which the product is made, or where the manufacturing process steps would be expected to impart distinctive structural characteristics to the final product.
The claim additionally states that the stored leukoreduced whole blood composition, which is specifically stored oxygen and carbon dioxide reduced leukoreduced whole blood with platelets (OCR-LRWB+PLT), has the property of having greater 2,3-DAG level after 15 days of storage than before (prior) to storage. However, the claim is only drawn to a “stored” leukoreduced whole blood composition. As above, this implies storage for any amount of time. Thus, this step and corresponding property have been interpreted as being optional and not necessarily limiting the stored leukoreduced whole blood composition.
Furthermore, the claim describes “pre-storage” properties of the leukoreduced whole blood. However, the claim is drawn to a “stored” leukoreduced whole blood composition, not a “pre-stored” composition. Therefore, this property has been interpreted not necessarily limiting the stored leukoreduced whole blood composition.
As a result, the only properties that have been interpreted as limiting to the stored leukoreduced whole blood composition are a) that it has an SO2 level of 30% or less and b) a partial pressure of carbon dioxide of less than 60 mmHg.
Turning to the prior art, Yoshida 2012 discloses a stored “red blood cell sample” (paragraph [0005]; claim 1). Yoshida discloses that this sample can be whole blood specifically (paragraph [0006]; claim 14). Yoshida 2012 discloses that the sample can be treated to remove leukocytes (leukoreduced) (paragraph [0011]).
Yoshida 2012 discloses that the sample can be depleted of both oxygen and carbon dioxide and stored in an oxygen and carbon dioxide impermeable environment for storage (claim 1; paragraph [0006]) (thus, the blood composition is both oxygen and carbon dioxide reduced (OCR), and stored under OCR conditions).
In regards to platelets, while Yoshida 2012 is silent on whether the blood comprises platelets. However, since Yoshida explicitly discloses that the sample can be “whole blood” (paragraph [0006]; claim 14), which a person of ordinary skill in the art would have recognized that the composition comprises platelets.
It is noted that although in some embodiments Yoshida 2012 discloses that a PRP fraction was discarded (paragraph 26), it is well-known that at least some platelets co-centrifuge with the RBC fraction and instant claims do not require a specific number of platelets. Moreover, again as above, Yoshida 2012 explicitly discloses that the sample can be “whole blood” which comprises platelets.
Again, Yoshida 2012 discloses that both O2 and CO2 are reduced from the blood (paragraph [0006]). Yoshida discloses that the partial pressure of O2 and CO2 can be reduced to about 10 mmHg and 5 mmHg, respectively (paragraph [0015]).
A partial pressure of 5 mmHg CO2 overlaps with the range of less than 60 mmHg as in claim 1 (or between 1 and 60 mmHg as in claim 39; or between 1 and 20 mmHg as in claim 90).
In regards to oxygen, as evidenced by Severinghaus, oxygen at a partial pressure of 10 mmHg (mmHg = 1 Torr) is percent saturation of about 9.58%, which is less than 30% as in claim 1 (or 20% as in claim 38; or 10% as in claim 90). Note that in regard to claims 89-90, as stated above, the “pre-storage” conditions are optional and have not been considered to limit the structure of the “stored” composition.
Finally, in regards to 2,3-DPG levels over time, as above, this has been interpreted as optional step, and the process steps do not require storing the whole blood for more than 15 days. Additionally, this appears to be a natural consequence property of storing the composition for at least 15 days in the conditions as in claim 1.
Moreover, as disclosed by Yoshida 2012, removal of carbon dioxide provides for improved maintenance of 2,3-DPG (paragraph [0007]), and removal of oxygen and carbon dioxide results in higher levels of 2,3-DPG following three weeks of storage compared to samples in which either oxygen nor carbon dioxide were depleted (paragraphs [0021, 0033]).
Therefore, the carbon dioxide and oxygen reduced blood compositions as disclosed by Yoshida 2012 would result in a greater 2,3-DPG levels after 15 days of storage.
In regards to the effect of the preamble, that the composition is “for” transfusion to a trauma patient in need of multiple transfusions, Applicant should note that this is an intended use of the composition (see MPEP 2111.02). Since the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention and does not result in a structural difference between the claimed invention and the prior art, it is not considered limiting. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020); Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020); In re Otto, 312 F.2d 937, 938, 136 USPQ 458, 459 (CCPA 1963).
However, even if it were, Yoshida 2012 discloses that the composition can be transfused to patients (paragraph [0022]), the blood composition of Yoshida 2012, is at least capable of performing this intended use.
In regards to claim 40, Yoshida discloses embodiments wherein AS-3 (which comprises citrate-phosphate-dextrose and adenine) is added to is added to blood (paragraph [0031]).
In regards to claim 41, whether the OCR-LRWB has reduced levels of a biologic modifier (BRM) selected from the group consisting of a cytokine, a chemokine, an ispropstane, and an oxidized lipid product relative to non-OCR-LRWB, this appears to be a property of OCR-LRWB not a limitation per se.
This is supported by the specification which states “oxygen reduced leukoreduced whole blood (OR-LRWB) . . . has reduced levels of biological response modifiers (BRMs) relative to conventionally stored whole blood (paragraph [0074]).
Additionally, as evidenced by Sharma, it is known in the art that the process of leukoreduction itself is sufficient reduce inflammatory cytokines (BRMs) accumulation during storage which reduces immune responses in patients (with a variety of conditions) following transfusion (Timing of Leukofiltration, p4).
Therefore, since Yoshida 2012 discloses the stored leukoreduced whole blood product of claim 35, the product as disclosed by Yoshida 2012, would appear to have the same properties as in claims 41 absent evidence to the contrary.
In regards to claims 42-46 and 48, whether the leukoreduced whole blood product has reduced inflammatory response relative to a patient in need with a different blood product (as are any of the other conditions in claims 43-48, such as “reduced immune modulation”, as in claim 43), these are also properties of the if transfused in the patient and are intended uses.
In the instant case, as above, as evidenced by Sharma, it is known in the art that the process of leukoreduction itself is sufficient reduce inflammatory cytokines (BRMs) accumulation during storage which reduces immune responses in patients (with a variety of conditions) following transfusion (Timing of Leukofiltration, p4).
Therefore, since Yoshida 2012 discloses the stored leukoreduced whole blood product of claim 35, the product as disclosed by Yoshida 2012, would appear to have the same properties as in claims 42-46 and 48 or would be expected to be suitable for these intended uses absent evidence to the contrary.
In regards to claims 49-52, regards to whether the leukoreduced whole blood has equivalent or better coagulation parameters as measured by thromboelastography (or equivalent or better parameters or levels of conditions in claims 50-52), these are properties of stored leukoreduced whole blood, if measured, and do not require additional process steps. Thus, they have been interpreted as optional. Furthermore, since Yoshida 2012 discloses the stored leukoreduced whole blood product of claim 35, the product as disclosed by Yoshida 2012, would appear to have the same properties as in claims 449-52 is further process steps were performed, absent evidence to the contrary.
In the instant case, as above, as evidenced by Sharma, it is known in the art that the process of leukoreduction itself is sufficient reduce platelet-refractoriness (p.5, col2, see Table 3), thereby allowed stored leukoreduced blood to exhibit equivalent or greater TEG coagulation parameters than stored non-leukoreduced blood.
In regards to claim 53, Yoshida discloses that the blood can be stored for at least three weeks (paragraph [0006]).
In regards to claim 91, these are intended uses of the preamble (see MPEP 2111.02). As discussed above, Yoshida 2012 discloses that the composition can be transfused to patients broadly (paragraph [0022]). Therefore, Yoshida 2012 appears suitable for these intended uses absent evidence to the contrary.
Therefore, Yoshida discloses the invention as claimed.
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.
Claim 92 is rejected under 35 U.S.C. 103 as being unpatentable over Yoshida et al. (US20120225416A1, on IDS 04/27/2021, hereafter “Yoshida 2012”, previously cited) in view of view of Masse (Transfus Clin Biol, 2001, previously cited), as evidenced Severinghaus (Journal of Applied Physiology, 46(3): 599-602, 1979, previously cited).
Yoshida discloses claim 35 as discussed above.
In regards to claim 92, as above, Yoshida 2012 teaches that the whole blood can be depleted, but is silent as to the level of reduction. However, a person ordinary skill in the art would have been motivated to reduce white blood cells by at least 5 logs in order to reduce the chances of triggering an immune response in recipients, and because as taught by Masse, this reduces more than 99.90% of leukocytes (Leukocyte technology, p298). Furthermore, because as taught by Masse, methods for reducing leukocytes by 5 logs is known in the art (Leukocyte technology, p298), it could have been done with predictable results and a reasonable expectation of success.
Therefore, the combined teachings of Yoshida 2012 and Masse renders the invention unpatentable as claimed.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 35-46, 48-53, and 89-92 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 17/772,947 as evidenced by Yoshida et al. (US20120225416A1, on IDS 04/27/2021, hereafter “Yoshida 2012”, previously cited).
Although the conflicting claims of copending Application No. 17/772,947 are not identical to the currently prosecuted claims 35-46, 48-53, and 89-92, they are not patently distinct from each other because said claims of both inventions are drawn to stored oxygen-reduced blood that can be whole blood (which comprises platelets) and leukoreduced, wherein the blood is oxygen and carbon dioxide-reduced, at levels of less than 30% and 60 mm Hg, respectively.
While the co-pending Application is silent as to levels of 2,3-DPG after 15 days of storage, this has been interpreted as optional step, and the process steps do not require storing the whole blood for more than 15 days. Additionally, this appears to be a natural consequence property of storing the composition for at least 15 days in the conditions as in claim 1.
Moreover, as evidenced by Yoshida 2012, removal of carbon dioxide provides for improved maintenance of 2,3-DPG (paragraph [0007]), and removal of oxygen and carbon dioxide results in higher levels of 2,3-DPG following three weeks of storage compared to samples in which either oxygen nor carbon dioxide were depleted (paragraphs [0021, 0033]).
Therefore, a carbon dioxide and oxygen reduced blood would result in a greater 2,3-DPG levels after 15 days of storage.
In regards to whether the stored blood can be administered to a trauma patient, in regards to the effect of the preamble, that the composition is “for” transfusion to a trauma patient in need of multiple transfusions, Applicant should note that this is an intended use of the composition (see MPEP 2111.02). Since the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention and does not result in a structural difference between the claimed invention and the prior art, it is not considered limiting. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020); Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020); In re Otto, 312 F.2d 937, 938, 136 USPQ 458, 459 (CCPA 1963).
However, even if it were, the co-pending Application is still drawn to a stored oxygen-reduced blood that can be whole blood (which comprises platelets) and leukoreduced, wherein the blood is oxygen and carbon dioxide-reduced, at levels of less than 30% and 60 mm Hg, respectively, and therefore, is suitable for this intended use.
This is a provisional nonstatutory double patenting rejection.
Claims 35-46, 48-53, and 89-92 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/152,140 as evidenced by Yoshida et al. (US20120225416A1, on IDS 04/27/2021, hereafter “Yoshida 2012”, previously cited).
Although the conflicting claims of copending Application No. 18/152,140 are not identical to the currently prosecuted claims 35-46, 48-53, and 89-92, they are not patently distinct from each other because said claims of both inventions are drawn to stored oxygen-reduced blood that can be whole blood (which comprises platelets) and leukoreduced, wherein the blood is oxygen and carbon dioxide-reduced, at levels of less than 30% and 60 mm Hg, respectively.
While the co-pending Application is silent as to levels of 2,3-DPG after 15 days of storage, this has been interpreted as optional step, and the process steps do not require storing the whole blood for more than 15 days. Additionally, this appears to be a natural consequence property of storing the composition for at least 15 days in the conditions as in claim 1.
Moreover, as evidenced by Yoshida 2012, removal of carbon dioxide provides for improved maintenance of 2,3-DPG (paragraph [0007]), and removal of oxygen and carbon dioxide results in higher levels of 2,3-DPG following three weeks of storage compared to samples in which either oxygen nor carbon dioxide were depleted (paragraphs [0021, 0033]).
Therefore, a carbon dioxide and oxygen reduced blood would result in a greater 2,3-DPG levels after 15 days of storage.
This is a provisional nonstatutory double patenting rejection.
Claims 35-46, 48-53, and 89-92 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 35, 49, 89-105 of copending Application No. 17/954,138 in view of Yoshida et al. (US2013/0004937A1, 2013, on IDS 04/27/2021, previously cited) as evidenced by Yoshida et al. (US20120225416A1, on IDS 04/27/2021, hereafter “Yoshida 2012”, previously cited).
Although the conflicting claims of copending Application No. 17/954,138 are not identical to the currently prosecuted claims 35-46, 48-53, and 89-92, they are not patently distinct from each other because said claims of both inventions are drawn to stored oxygen-reduced blood that can be whole blood (which comprises platelets) , wherein the blood is oxygen and carbon dioxide-reduced, at levels of less than 30% and 60 mm Hg, respectively.
While the copending Application does not explicitly require that the blood composition be leukoreduced, a person of ordinary skill in the art would have been motivated to leukoreduce the blood because Yoshida teaches that leukoreduction may include removing white blood cells that can carry viruses and cause fevers (paragraph [0026]). Furthermore, because Yoshida teaches a system leukoreducing whole blood (paragraphs [0026, 0035, etc.; Fig. 2), it could have been done with predictable results and a reasonable expectation of success.
While the co-pending Application is silent as to levels of 2,3-DPG after 15 days of storage, this has been interpreted as optional step, and the process steps do not require storing the whole blood for more than 15 days. Additionally, this appears to be a natural consequence property of storing the composition for at least 15 days in the conditions as in claim 1.
Moreover, as evidenced by Yoshida 2012, removal of carbon dioxide provides for improved maintenance of 2,3-DPG (paragraph [0007]), and removal of oxygen and carbon dioxide results in higher levels of 2,3-DPG following three weeks of storage compared to samples in which either oxygen nor carbon dioxide were depleted (paragraphs [0021, 0033]).
Therefore, a carbon dioxide and oxygen reduced blood would result in a greater 2,3-DPG levels after 15 days of storage.
This is a provisional nonstatutory double patenting rejection.
Claims 35-46, 48-53, and 89-92 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 19, 22-23, 28, 30, 33-36, 38, 41, 43-47 of copending Application No. 16/289,118 in view of Yoshida et al. (US2013/0004937A1, 2013, on IDS 04/27/2021, previously cited) as evidenced by Yoshida et al. (US20120225416A1, on IDS 04/27/2021, hereafter “Yoshida 2012”, previously cited).
Although the conflicting claims of copending Application No. 16/289,118 are not identical to the currently prosecuted claims 35-46, 48-53, and 89-92, they are not patently distinct from each other because said claims of both inventions are drawn to stored oxygen-reduced blood that can be whole blood (which comprises platelets) , wherein the blood is oxygen and carbon dioxide-reduced, at levels of less than 30% and 60 mm Hg, respectively, and with 2,3-DPG levels that are higher after storage.
While the copending Application does not explicitly require that the blood composition be leukoreduced, a person of ordinary skill in the art would have been motivated to leukoreduce the blood because Yoshida teaches that leukoreduction may include removing white blood cells that can carry viruses and cause fevers (paragraph [0026]). Furthermore, because Yoshida teaches a system leukoreducing whole blood (paragraphs [0026, 0035, etc.; Fig. 2), it could have been done with predictable results and a reasonable expectation of success.
While the co-pending Application is silent as to levels of 2,3-DPG after 15 days of storage, this has been interpreted as optional step, and the process steps do not require storing the whole blood for more than 15 days. Additionally, this appears to be a natural consequence property of storing the composition for at least 15 days in the conditions as in claim 1.
Moreover, as evidenced by Yoshida 2012, removal of carbon dioxide provides for improved maintenance of 2,3-DPG (paragraph [0007]), and removal of oxygen and carbon dioxide results in higher levels of 2,3-DPG following three weeks of storage compared to samples in which either oxygen nor carbon dioxide were depleted (paragraphs [0021, 0033]).
Therefore, a carbon dioxide and oxygen reduced blood would result in a greater 2,3-DPG levels after 15 days of storage.
This is a provisional nonstatutory double patenting rejection.
Claims 35-46, 48-53, and 89-92 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 109-116 and 121-128 of copending Application No. 18/297,193 in view of Yoshida et al. (US20120225416A1, on IDS 04/27/2021, hereafter “Yoshida 2012”, previously cited).
Although the conflicting claims of copending Application No. 18/297,193 are not identical to the currently prosecuted claims 35-46, 48-53, and 89-92, they are not patently distinct from each other because said claims of both inventions are drawn to stored oxygen-reduced blood that can be whole blood (which comprises platelets) , wherein the blood is oxygen-reduced, at levels of less than 30%.
While the co-pending Application does not explicitly requiring reducing carbon dioxide to a level of 69 mmHg or less, a person of ordinary skill in the art would have been motivated to do so because Yoshida 2012 teaches that depleting red blood cells samples (including whole blood) enhances red blood cell quality and survival during storage (paragraph [0011]; claim 14). Furthermore, because Yoshida 2012 teaches methods for depleting whole blood samples of carbon dioxide below 60 mmHg (claims 1, 10, and 14), it could have been done with predictable results and a reasonable expectation of success.
In regards to an increased 2,3-DAG level after 15 days of storage, as discussed above, this has been interpreted as optional step, and the process steps do not require storing the whole blood for more than 15 days. Additionally, this appears to be a natural consequence property of storing the composition for at least 15 days in the conditions as in claim 1.
However, as taught by Yoshida 2012, removal of carbon dioxide provides for improved maintenance of 2,3-DPG (paragraph [0007]), and removal of oxygen and carbon dioxide results in higher levels of 2,3-DPG following three weeks of storage compared to samples in which either oxygen nor carbon dioxide were depleted (paragraphs [0021, 0033]).
Therefore, a carbon dioxide and oxygen reduced blood would result in a greater 2,3-DPG levels after 15 days of storage.
In regards to whether the stored blood can be administered to a trauma patient, in regards to the effect of the preamble, that the composition is “for” transfusion to a trauma patient in need of multiple transfusions, Applicant should note that this is an intended use of the composition (see MPEP 2111.02). Since the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention and does not result in a structural difference between the claimed invention and the prior art, it is not considered limiting. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020); Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020); In re Otto, 312 F.2d 937, 938, 136 USPQ 458, 459 (CCPA 1963).
However, even if it were, the co-pending Application is still drawn to a stored oxygen-reduced blood that can be whole blood (which comprises platelets) and leukoreduced, wherein the blood is oxygen-reduced, at levels of less than 30%, and is therefore, is suitable for this intended use.
This is a provisional nonstatutory double patenting rejection.
Claims 35-46, 48-53, and 89-92 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 11,033,581 B2 in view of Yoshida et al. (US20120225416A1, on IDS 04/27/2021, hereafter “Yoshida 2012”, previously cited).
Although the conflicting claims of copending U.S. Patent No. 11,033,581 are not identical to the currently prosecuted claims 35-46, 48-53, and 89-92, they are not patently distinct from each other because said claims of both inventions are drawn to stored oxygen-reduced blood that can be whole blood (which comprises platelets), wherein the blood is oxygen-reduced, at levels of less than 30%.
While the co-pending patent is does not explicitly requiring reducing carbon dioxide to a level of 69 mmHg or less, a person of ordinary skill in the art would have been motivated to do so because Yoshida 2012 teaches that depleting red blood cells samples (including whole blood) enhances red blood cell quality and survival during storage (paragraph [0011]; claim 14). Furthermore, because Yoshida 2012 teaches methods for depleting whole blood samples of carbon dioxide below 60 mmHg (claims 1, 10, and 14), it could have been done with predictable results and a reasonable expectation of success.
In regards to an increased 2,3-DAG level after 15 days of storage, as discussed above, this has been interpreted as optional step, and the process steps do not require storing the whole blood for more than 15 days. Additionally, this appears to be a natural consequence property of storing the composition for at least 15 days in the conditions as in claim 1.
However, as taught by Yoshida 2012, removal of carbon dioxide provides for improved maintenance of 2,3-DPG (paragraph [0007]), and removal of oxygen and carbon dioxide results in higher levels of 2,3-DPG following three weeks of storage compared to samples in which either oxygen nor carbon dioxide were depleted (paragraphs [0021, 0033]).
Therefore, a carbon dioxide and oxygen reduced blood would result in a greater 2,3-DPG levels after 15 days of storage.
In regards to whether the stored blood can be administered to a trauma patient, in regards to the effect of the preamble, that the composition is “for” transfusion to a trauma patient in need of multiple transfusions, Applicant should note that this is an intended use of the composition (see MPEP 2111.02). Since the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention and does not result in a structural difference between the claimed invention and the prior art, it is not considered limiting. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020); Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020); In re Otto, 312 F.2d 937, 938, 136 USPQ 458, 459 (CCPA 1963).
However, even if it were, the co-pending Application is still drawn to a stored oxygen-reduced blood that can be whole blood (which comprises platelets) and leukoreduced, wherein the blood is oxygen-reduced, at levels of less than 30%, and is therefore, is suitable for this intended use.
Claims 35-46, 48-53, and 89-92 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,576,931 B2 as evidenced by Yoshida et al. (US20120225416A1, on IDS 04/27/2021, hereafter “Yoshida 2012”, previously cited).
Although the conflicting claims of copending U.S. Patent No. 11,576,931 are not identical to the currently prosecuted claims 35-46, 48-53, and 89-92, they are not patently distinct from each other because said claims of both inventions are drawn to stored oxygen-reduced blood that can be whole blood (which comprises platelets), for treating trauma patients wherein the blood is oxygen-reduced, at levels of less than 30% and carbon dioxide reduces at a level of 60 mmHg or less.
In regards to an increased 2,3-DAG level after 15 days of storage, as discussed above, this has been interpreted as optional step, and the process steps do not require storing the whole blood for more than 15 days. Additionally, this appears to be a natural consequence property of storing the composition for at least 15 days in the conditions as in claim 1.
However, as evidenced by Yoshida 2012, removal of carbon dioxide provides for improved maintenance of 2,3-DPG (paragraph [0007]), and removal of oxygen and carbon dioxide results in higher levels of 2,3-DPG following three weeks of storage compared to samples in which either oxygen nor carbon dioxide were depleted (paragraphs [0021, 0033]).
Therefore, a carbon dioxide and oxygen reduced blood would result in a greater 2,3-DPG levels after 15 days of storage.
Claims 35-46, 48-53, and 89-92 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 10,583,192 B2.
Although the conflicting claims of copending U.S. Patent No. 10,583,192 are not identical to the currently prosecuted claims 35-46, 48-53, and 89-92, they are not patently distinct from each other because said claims of both inventions are drawn to stored oxygen-reduced blood that can be whole blood (which comprises platelets), for treating trauma patients wherein the blood is oxygen-reduced, at levels of less than 30% and carbon dioxide reduces at a level of 60 mmHg or less and where 2,3-DPG levels that are higher after storage.
Claims 35-46, 48-53, and 89-92 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 11,147,876 B2 in view of Yoshida et al. (US20120225416A1, on IDS 04/27/2021, hereafter “Yoshida 2012”, previously cited).
Although the conflicting claims of copending U.S. Patent No. 11,147,876 are not identical to the currently prosecuted claims 35-46, 48-53, and 89-92, they are not patently distinct from each other because said claims of both inventions are drawn to stored oxygen-reduced blood that can be whole blood (which comprises platelets), for administration to a trauma patient wherein the blood is oxygen-reduced, at levels of less than 30%.
While the co-pending patent is does not explicitly requiring reducing carbon dioxide to a level of 69 mmHg or less, a person of ordinary skill in the art would have been motivated to do so because Yoshida 2012 teaches that depleting red blood cells samples (including whole blood) enhances red blood cell quality and survival during storage (paragraph [0011]; claim 14). Furthermore, because Yoshida 2012 teaches methods for depleting whole blood samples of carbon dioxide below 60 mmHg (claims 1, 10, and 14), it could have been done with predictable results and a reasonable expectation of success.
In regards to an increased 2,3-DAG level after 15 days of storage, as discussed above, this has been interpreted as optional step, and the process steps do not require storing the whole blood for more than 15 days. Additionally, this appears to be a natural consequence property of storing the composition for at least 15 days in the conditions as in claim 1.
However, as taught by Yoshida 2012, removal of carbon dioxide provides for improved maintenance of 2,3-DPG (paragraph [0007]), and removal of oxygen and carbon dioxide results in higher levels of 2,3-DPG following three weeks of storage compared to samples in which either oxygen nor carbon dioxide were depleted (paragraphs [0021, 0033]).
Therefore, a carbon dioxide and oxygen reduced blood would result in a greater 2,3-DPG levels after 15 days of storage.
Claims 35-46, 48-53, and 89-92 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 11,911,471 B2 as evidenced by Yoshida et al. (US20120225416A1, on IDS 04/27/2021, hereafter “Yoshida 2012”, previously cited).
Although the conflicting claims of copending U.S. Patent No. 11,911,471 are not identical to the currently prosecuted claims 35-46, 48-53, and 89-92, they are not patently distinct from each other because said claims of both inventions are drawn to stored oxygen-reduced blood that can be whole blood (which comprises platelets), for treating trauma patients wherein the blood is oxygen-reduced, at levels of less than 30% and carbon dioxide reduces at a level of 60 mmHg or less and where 2,3-DPG levels that are higher after storage.
In regards to an increased 2,3-DAG level after 15 days of storage, as discussed above, this has been interpreted as optional step, and the process steps do not require storing the whole blood for more than 15 days. Additionally, this appears to be a natural consequence property of storing the composition for at least 15 days in the conditions as in claim 1.
However, as taught by Yoshida 2012, removal of carbon dioxide provides for improved maintenance of 2,3-DPG (paragraph [0007]), and removal of oxygen and carbon dioxide results in higher levels of 2,3-DPG following three weeks of storage compared to samples in which either oxygen nor carbon dioxide were depleted (paragraphs [0021, 0033]).
Therefore, a carbon dioxide and oxygen reduced blood would result in a greater 2,3-DPG levels after 15 days of storage.
Claims 35-46, 48-53, and 89-92 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,364,760 B2 as evidenced by Yoshida et al. (US20120225416A1, on IDS 04/27/2021, hereafter “Yoshida 2012”, previously cited).
Although the conflicting claims of copending U.S. Patent No. 12,364,760 are not identical to the currently prosecuted claims 35-46, 48-53, and 89-92, they are not patently distinct from each other because said claims of both inventions are drawn to stored oxygen-reduced blood that can be whole blood (which comprises platelets), for treating trauma patients wherein the blood is oxygen-reduced, at levels of less than 30% and carbon dioxide reduces at a level of 60 mmHg or less and where 2,3-DPG levels that are higher after storage.
In regards to an increased 2,3-DAG level after 15 days of storage, as discussed above, this has been interpreted as optional step, and the process steps do not require storing the whole blood for more than 15 days. Additionally, this appears to be a natural consequence property of storing the composition for at least 15 days in the conditions as in claim 1.
However, as taught by Yoshida 2012, removal of carbon dioxide provides for improved maintenance of 2,3-DPG (paragraph [0007]), and removal of oxygen and carbon dioxide results in higher levels of 2,3-DPG following three weeks of storage compared to samples in which either oxygen nor carbon dioxide were depleted (paragraphs [0021, 0033]).
Therefore, a carbon dioxide and oxygen reduced blood would result in a greater 2,3-DPG levels after 15 days of storage.
Claims 35-46, 48-53, and 89-92 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 11,013,771 B2 in view of Yoshida et al. (US20120225416A1, on IDS 04/27/2021, hereafter “Yoshida 2012”, previously cited).
Although the conflicting claims of copending U.S. Patent No. 11,013,771 are not identical to the currently prosecuted claims 35-46, 48-53, and 89-92, they are not patently distinct from each other because said claims of both inventions are drawn to stored oxygen-reduced blood that can be whole blood (which comprises platelets), for administration to a trauma patient wherein the blood is oxygen-reduced, at levels of less than 30%.
While the co-pending patent is does not explicitly requiring reducing carbon dioxide to a level of 69 mmHg or less, a person of ordinary skill in the art would have been motivated to do so because Yoshida 2012 teaches that depleting red blood cells samples (including whole blood) enhances red blood cell quality and survival during storage (paragraph [0011]; claim 14). Furthermore, because Yoshida 2012 teaches methods for depleting whole blood samples of carbon dioxide below 60 mmHg (claims 1, 10, and 14), it could have been done with predictable results and a reasonable expectation of success.
In regards to an increased 2,3-DAG level after 15 days of storage, as discussed above, this has been interpreted as optional step, and the process steps do not require storing the whole blood for more than 15 days. Additionally, this appears to be a natural consequence property of storing the composition for at least 15 days in the conditions as in claim 1.
However, as taught by Yoshida 2012, removal of carbon dioxide provides for improved maintenance of 2,3-DPG (paragraph [0007]), and removal of oxygen and carbon dioxide results in higher levels of 2,3-DPG following three weeks of storage compared to samples in which either oxygen nor carbon dioxide were depleted (paragraphs [0021, 0033]).
Therefore, a carbon dioxide and oxygen reduced blood would result in a greater 2,3-DPG levels after 15 days of storage.
Claims 35-46, 48-53, and 89-92 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 9,339,025 B2 as evidenced by Severinghaus (Journal of Applied Physiology, 46(3): 599-602, 1979, previously cited) and Yoshida et al. (US20120225416A1, on IDS 04/27/2021, hereafter “Yoshida 2012”, previously cited).
Although the conflicting claims of copending U.S. Patent No. 9,339,025 are not identical to the currently prosecuted claims 35-46, 48-53, and 89-92, they are not patently distinct from each other because said claims of both inventions are drawn to stored oxygen-reduced blood that can be whole blood (which comprises platelets), for administration to a trauma patient wherein the blood is oxygen-reduced, at levels of less than 30% (as evidenced by Severinghaus, 10 mmHg O2 is an oxygen saturation of 9.58%) and wherein carbon dioxide is reduced to less than 60 mm Hg.
In regards to an increased 2,3-DAG level after 15 days of storage, as discussed above, this has been interpreted as optional step, and the process steps do not require storing the whole blood for more than 15 days. Additionally, this appears to be a natural consequence property of storing the composition for at least 15 days in the conditions as in claim 1.
However, as evidenced by Yoshida 2012, removal of carbon dioxide provides for improved maintenance of 2,3-DPG (paragraph [0007]), and removal of oxygen and carbon dioxide results in higher levels of 2,3-DPG following three weeks of storage compared to samples in which either oxygen nor carbon dioxide were depleted (paragraphs [0021, 0033]).
Therefore, a carbon dioxide and oxygen reduced blood would result in a greater 2,3-DPG levels after 15 days of storage.
Claims 35-46, 48-53, and 89-92 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 10,251,387 B2 as evidenced by Severinghaus (Journal of Applied Physiology, 46(3): 599-602, 1979, previously cited) and Yoshida et al. (US20120225416A1, on IDS 04/27/2021, hereafter “Yoshida 2012”, previously cited).
Although the conflicting claims of copending U.S. Patent No. 10,251,387 are not identical to the currently prosecuted claims 35-46, 48-53, and 89-92, they are not patently distinct from each other because said claims of both inventions are drawn to stored oxygen-reduced blood that can be whole blood (which comprises platelets), for administration to a trauma patient wherein the blood is oxygen-reduced, at levels of less than 30% (as evidenced by Severinghaus, 10 mmHg O2 is an oxygen saturation of 9.58%) and wherein carbon dioxide is reduced to less than 60 mm Hg.
In regards to an increased 2,3-DAG level after 15 days of storage, as discussed above, this has been interpreted as optional step, and the process steps do not require storing the whole blood for more than 15 days. Additionally, this appears to be a natural consequence property of storing the composition for at least 15 days in the conditions as in claim 1.
However, as evidenced by Yoshida 2012, removal of carbon dioxide provides for improved maintenance of 2,3-DPG (paragraph [0007]), and removal of oxygen and carbon dioxide results in higher levels of 2,3-DPG following three weeks of storage compared to samples in which either oxygen nor carbon dioxide were depleted (paragraphs [0021, 0033]).
Therefore, a carbon dioxide and oxygen reduced blood would result in a greater 2,3-DPG levels after 15 days of storage.
Response to Arguments
Applicant argues that the claims as amended are now specifically drawn to stored oxygen and carbon dioxide-reduced leukoreduced whole blood composition, wherein the storage is under oxygen and carbon dioxide reduced (OCR) conditions (Remarks, p6). Applicant argues that this is not disclosed by Yoshida 2012 and therefore, the claims are not anticipated under 35 USC 102 (Remarks, p6-9).
Applicant's arguments filed 06/11/2025 have been fully considered but they are not persuasive.
As discussed above, Yoshida 2012 explicitly discloses that the sample can be depleted of both oxygen and carbon dioxide and stored in an oxygen and carbon dioxide impermeable environment for storage (claim 1; paragraph [0006]) (thus, the blood composition is both oxygen and carbon dioxide reduced (OCR), and stored under OCR conditions).
Applicant argues that while they agree that Yoshida 2012 discloses whole blood, the Examiner has not shown where Yoshida discloses oxygen and carbon dioxide reduced leukoreduced whole blood or even stored oxygen and carbon dioxide leukoreduced whole blood (with platelets) for transfusion to a trauma patient in need of multiple transfusions (Remarks, p7). Instead, Applicant argues, Yoshida 2012 discloses preparing red blood cells from whole blood, and therefore, considered as a whole, is directed towards deoxygenating and storing packed red blood cells, from which platelets have been removed (Remarks, p7).
Applicant's arguments filed 06/11/2025 have been fully considered but they are not persuasive.
In regards to red blood cells, as discussed above, the stored blood composition of Yoshida 2012 is specifically a “red blood cell sample” (paragraph [0005]; claim 1), which can explicitly be whole blood specifically (paragraph [0006]; claim 14).
Yoshida 2012 also discloses that the sample can be treated to remove leukocytes (leukoreduced) (paragraph [0011]).
Indeed, expanding on what is considered a “red blood cell sample”, Yoshida 2012 (Claim 14) more fully discloses “the red blood cell sample is selected from the group consisting of whole blood, anti-coagulated whole blood, packed red cells and red cells separated from plasma.”
Thus, the stored blood composition of Yoshida 2012 refers to any blood composition that comprises red blood cells (including whole blood), and not only packed red blood cells as argued by Applicant.
In regards to platelets, Yoshida 2012 does not require removal of platelets and whole blood comprises platelets.
While Yoshida 2012 discloses specific embodiments in which a platelet-rich plasma fraction of supernatant was expressed into a bag and discarded (paragraph [0026]), as discussed above, ), it is well-known that at least some platelets co-centrifuge with the RBC fraction and the instant claims do not require a specific number of platelets.
Furthermore, as discussed above, Yoshida explicitly states that the red blood cell sample is selected from the group consisting of “whole blood . . . and red cells separated from plasma” (claim 14) and therefore, an embodiment of a red blood sample that is whole blood that is different from an embodiment wherein red cells separated from plasma (such as plasma-rich fraction) is expressly envisioned by the disclosure of Yoshida.
Applicant argues that prior to Applicant’s filing, depleting oxygen from whole blood (which Applicant acknowledges comprises platelets) was understood to be detrimental, as undesirable morphological changes result from depriving platelets of oxygen (Remarks, p7-8). As evidence, Applicant cites Murphy et al. (Blood, 1975), etc. (see footnote 1, p7), who Applicant argues teache away from the deoxygenation of whole blood (Remarks, p7-8).
Continuing, Applicant argues that as provided in the specification, that it was known at the timing of filing that “[w]hen platelets are stored at refrigerated temperature, post-transfusion is lost” and that “[t]hese findings, among others, led to practice standardization ensuring the oxygenation of platelets during room temperature storage to maximize post-transfusion viability” (Remarks, p8).
Applicant's arguments filed 06/11/2025 have been fully considered but they are not persuasive.
An oxygen and carbon dioxide-reduced whole blood composition is explicitly disclosed by Yoshida 2012 as discussed above.
In regards to the cited prior art references, it is noted that Applicant does not cite specific information from these references, but only lists them as asserting that they demonstrate a teaching away from a whole blood composition comprising platelets under oxygen-reduced levels.
However, it is also noted that these references appear to discuss the effects of oxygen on platelets concentrates at specific temperatures (e.g., see (a) Murphy et al., “platelet storage at 22 degree C . . .”, (b) Moroff et al., “Factors Influencing Changes in pH during Storage of platelet concentrates at 20-24°C”, (c) Wallvik et al., “Platelet concentrates at 22C need oxygen”) which is not commensurate in scope the claims because the claims are drawn to a whole blood composition comprising platelets, not platelet concentrates and because the composition does not require storage of whole blood at any particular temperature (nor for any particular amount of time).
Applicant argues that the specification in fact defines the term “stored” (Remarks, p8). As argued by Applicant, the Specification provides that “[a]s used herein, ‘stored red blood cells’ includes oxygen reduced or oxygen and carbon dioxide reduced red blood cells stored for 1 to 6°C” and that “stored red blood cells include red blood cells (RBC) present in whole blood” or “RBC present in leukoreduced whole blood” (Specification at [0043]; Remarks, p8).
Applicant further argues that the Specification makes a distinction from “stored” as recited in the claims and “conventionally stored” blood, and provide that “the terms “conventionally stored,” “conventional storage,” and “conventional conditions” include whole blood . . . stored in oxygen and carbon dioxide permeable container at 1 to 6°C without gas reduction steps prior to storage . . . both oxygen and carbon dioxide increase to ambient levels over time in conventionally stored whole blood . . . due to oxygen and carbon dioxide container permeability . . . While not traditionally considered conventional, for the purposes of the present disclosure, conventional storage can include storage at temperatures above 6°C (Specification at [0043]; Remarks, p8). Continuing, Applicant argues that this distinction is demonstrated in Example 7, or in Fig 4B (Remarks, p8-9).
Applicant's arguments filed 06/11/2025 have been fully considered but they are not persuasive.
The specification does not define the term “stored”, nor does the specification specifically defined the phrase “stored oxygen and carbon dioxide reduced leukoreduced whole blood.”
Rather, the specification only describes embodiments, of what the stored composition may be.
For example, as pointed out by Applicant, “[a]s used herein, ‘stored red blood cells’ includes oxygen reduced or oxygen and carbon dioxide reduced red blood cells stored for 1 to 6°C” (paragraph [0043]). However, because the storage may “include” other forms of storage, it is an embodiment, not a definition.
As another example, as pointed out by Applicant, “While not traditionally considered conventional, for the purposes of the present disclosure, conventional storage can include storage at temperatures above 6°C” (Specification at [0043]).
Again, because the storage “can” include types of storage, it is permissive, and can be an embodiment, but not explicitly define the term.
See also, MPEP 2111.01, But c.f. In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1369, 70 USPQ2d 1827, 1834 (Fed. Cir. 2004) (“We have cautioned against reading limitations into a claim from the preferred embodiment described in the specification, even if it is the only embodiment described, absent clear disclaimer in the specification”).
Therefore, as discussed below, since the term “stored” is not specifically defined by the specification, giving the term its broadest reasonable interpretation in view of the disclosure and the art, has been interpreted as meaning “[To] keep or accumulate (something) for future use” as evidenced by Oxford Languages.
Additionally, it is noted that, as discussed below, while the blood composition is “stored” and thus “kept or accumulated for future use”, the claim does not require any specific timing.
Applicant argues that Massie does not cure the deficiencies of Yoshida 2012 (Remarks, p10).
Applicant's arguments filed 06/11/2025 have been fully considered but they are not persuasive because Yoshida 2012 is not deficient as discussed above.
Applicant requests that the response to the double-patenting rejections be held in abeyance (Remarks, p10-11).
Applicant’s request is noted. The double-patenting rejections are maintained as discussed above.
Conclusion
No claims are allowed.
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/JOSEPH PAUL MIANO/Examiner, Art Unit 1631
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