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 .
Status of the Claims
Claims 35, 49 and 89-105 are pending.
Claims 90-92 and 95-96 were previously withdrawn pursuant to a restriction requirement.
Claims 49 and 89-92 are newly amended,
Claims 36-48, 50-88 and 106 are canceled
Claims 35, 49, 89, 93-94, 97-105 have been examined on the merits.
Withdrawn Objections & Rejections
Applicant's response filed 09/18/2025 has been considered. Rejections and/or objections not reiterated from the previous Office action mailed 03/20/2025 are hereby withdrawn.
The objections and rejections presented herein represent the full set of objections and rejections currently pending in the application.
Claim Rejections - 35 USC § 102
Claims 35, 49, 89, 93, 94, 97-102 and 105 are rejected under 35 U.S.C. 102(a)(1) or 35 U.S.C. 102(a)(2) as being anticipated by Yoshida(2012) et al. (US20120225416A1, on IDS 04/27/2021, hereafter “Yoshida(2012)”) as evidenced by Oxford Languages (retrieved from internet 03/31/2025), Severinghaus (Journal of Applied Physiology, 46(3): 599-602, 1979) and Cluitmans et al (BioMed Research International (2014)1-9).
This is a new rejection.
Regarding claim 35: The claim is drawn to an “oxygen reduced stored whole blood composition with platelets (OR-WB+PLT) for transfusion to a trauma patient in need thereof”.
While the claim requires that this composition be “stored”, neither the claimed nor the specification defined the term “stored”. Turing to the art, As defined by Oxford Languages (retrieved from internet 1/03/2025), 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, a “stored whole blood composition with platelets (OR-WB+PLT)” has been interpreted as whole blood that has been kept or accumulated for future use.
It is noted that 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 is storing 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 would still read 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 by the claims and therefore, blood drawn from a patient in vials (stored) is still stored whole blood.
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 describes “pre-storage” properties of the whole blood. However, the claim is drawn to a “stored” whole blood composition, not a “pre-stored” composition. Therefore, this property has been interpreted not necessarily limiting the stored whole blood composition. Thus the only property that has been interpreted as limiting to the stored whole blood composition is that it has an SO2 level of 30% or less.
The claim also recites coagulation parameters that are equivalent to or better than the same coagulation parameters in conventionally stored non-oxygen reduced whole blood with platelets (non-OR-WB+PLT). However, coagulation parameters are properties of stored whole blood, if measured, and do not require additional process steps. Thus, they have been interpreted as non-limiting.
Turning to the art, Yoshida(2012) discloses a stored red blood cell sample (paragraph [0006]). Yoshida(2012) discloses that the red blood cell sample refers to anti-coagulated whole blood (paragraph [0011], claim 14). Yoshida(2012) further discloses that the composition can be transfused to patients (paragraph [0022]).
In regards to platelets, while Yoshida(2012) is silent on whether the blood comprises platelets, as discussed above Yoshida(2012) discloses that the blood is “whole blood”, which a person of ordinary skill in the art would have recognized comprises platelets.
Yoshida(2012) discloses that O2 is reduced from the blood (paragraph [0006], claim 15). Yoshida(2012) discloses that the partial pressure of O2 can be reduced to about 10 mmHg (paragraph [0015], claim 15).
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 30% or less, as required by claim 35.
Yoshida(2012) is silent in regards to one or more coagulation parameter that is equivalent or better than the same one or more coagulation parameter in conventional stored non-oxygen reduced whole blood with platelets.
However, Yoshida(2012) teach a stored blood product that is indistinguishable from the claimed composition (whole blood with platelets with oxygen saturation of 30% or less in an anticoagulant solution) and thus the blood product of Yoshida(2012) would comprise the same properties as the claimed blood product, including anticoagulant properties, absent evidence to the contrary.
Regarding claims 49, 89, 93 and 94: The claims are drawn to whether the stored whole blood has equivalent or better coagulation parameters: thromboelastography angle of more than 40 and a prothrombin time between 10-15 seconds.
As evidenced by Stravitz, thromboelastography angle reflects the rate of fibrin formation and crosslinking of platelets (p515 col2 ¶2) and is used to record the assembly of a clot in whole blood (p513 ¶1). Also evidenced by Stravitz, prothrombin time is a standard test of coagulation which addresses plasmatic events in hemostasis (also evidenced by Stravitz p513 ¶1).
Thus a thromboelastography angle of more than 20 and a prothrombin time between 10-15 seconds, if measured, are properties of whole blood because whole blood comprises plasma and clotting factors, and the properties do not require additional process steps. Thus thromboelastography angle and prothrombin time have been interpreted as non-limiting.
However, if the factors were considered limiting, Yoshida(2012) teach a stored blood product that is indistinguishable from the claimed composition (whole blood with platelets with oxygen saturation of 30% or less in an anticoagulant solution) and thus the blood product of Yoshida(2012) would comprise the same properties as the claimed blood product, including a thromboelastography angle of more than 40 and a prothrombin time between 10-15 seconds, absent evidence to the contrary.
Regarding claim 97-100: As discussed supra, Yoshida(2012) is silent in regards to a platelet function that is equivalent or better than the platelet function in conventional stored non-oxygen reduced whole blood with platelets.
However, Yoshida(2012) teach a stored blood product that is indistinguishable from the claimed composition (whole blood with platelets with oxygen saturation of 30% or less in an anticoagulant solution) and thus the blood product of Yoshida(2012) would comprise the same properties as the claimed blood product, including platelet function that is equivalent or better than the platelet function in conventional stored while blood with platelets, if additional process steps were performed to measure said function, absent to evidence to the contrary.
Regarding claim 101: Yoshida(2012) is silent in regards to RBC deformability.
As evidenced by Cluitmans, red blood cells undergo extensive deformation when travelling through the microcapillaries (abstract), and thus red blood cell deformation is a property of red blood cells. Red blood cell deformability, if measured, is a property of the stored whole blood as taught by Yoshida(2012) because the stored whole blood comprises red blood cells, and does not require additional process steps. Thus, red blood cell deformability is interpreted as non-limiting.
However, if red blood cell deformability were interpreted as limiting, Yoshida(2012) teach a stored blood product that is indistinguishable from the claimed composition (whole blood with platelets with oxygen saturation of 30% or less in an anticoagulant solution) and thus the blood product would comprise the same properties as the claimed blood product, including higher RBC deformability compared to RBC deformability of conventionally stored whole blood, absent evidence to the contrary.
Regarding claim 102: Yoshida(2012) teach storage solution comprising AS3, which comprises citrate-phosphate-dextrose and adenine (p1 [0023]).
Regarding claim 105: Yoshida(2012) teach the storage period is at least three weeks (p3 [0006]).
The teachings of Yoshida(2012) anticipate Applicant’s invention as claimed.
Claims 35, 49, 89, 93-94, 97-102 and 105 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Delorme et al. (US 2015/0306288 A1), as evidenced by Bhattacharya et al. (J or Am. College of Surgeons (2005) 200(4):p557-563), Severinghaus (Journal of Applied Physiology, 46(3): 599-602, 1979) and Cluitmans et al (BioMed Research International (2014)1-9).
This rejection is a repeated rejection in regards to claims 35, 102 and 105 as stated in the action mailed 03/20/2025, and further comprises new rejections over claims 49, 89, 93-94, and 97-101.
Regarding claims 35, 102 and 105: The claims are interpreted as discussed supra.
Delorme teach a method for preserving whole placental blood (p1 para 0002). Whole placental blood provides a safe transfusion alternative to adult blood, as evidenced by Bhattacharya (title and background).
Delorme discloses the physiological concentration of oxygen in placental blood ranges from 1.1-4%, and using an air barrier bag can limit oxygen added to placental blood so that it remains close to physiological oxygen concentration (p3 para 0063). This reads on claim 35: having a pre-storage and storage oxygen saturation of 30% or less.
The placental whole blood is stored between 1-14 days, reading on claim 35 “stored for a storage period” (p3, col1 para 0068).
Delorme also teach that the whole blood can be added to the anticoagulant solution citrate phosphate dextrose (p3 col 1 para 0069, col2 para 0070).
While Delorme does not directly address the coagulation parameters in conventionally stored non-oxygen reduced whole blood compared to the disclosed oxygen reduced whole blood, they do teach that placental blood contains red cells, platelets and granulocytes, lymphocytes and cells that participate in hematopoietic reconstitution (p1 0004).
MPEP states “Where applicant claims a composition in terms of a function, property or characteristic and the composition of the prior art is the same as that of the claim but the function is not explicitly disclosed by the reference, the examiner may make a rejection under both 35 U.S.C. 102 and 103. "There is nothing inconsistent in concurrent rejections for obviousness under 35 U.S.C. 103 and for anticipation under 35 U.S.C. 102." And that that inherency may meet a missing claim limitation when the limitation is "the natural result of the combination of prior art elements." (emphasis in original) (2112).
Figure 5b of the instant application shows no significant difference between the coagulation parameter prothrombin time (PT) for oxygen reduced vs conventionally stored blood (p10 para 0030 ln 1-6). Coagulation parameters are inherent properties of whole blood, and aerobic or anaerobic storage will not affect those parameters for otherwise identical blood samples.
Regarding claims 49, 89, 93 and 94: The claims are drawn to whether the stored whole blood has equivalent or better coagulation parameters: thromboelastography angle of more than 40 and a prothrombin time between 10-15 seconds.
As evidenced by Stravitz, thromboelastography angle reflects the rate of fibrin formation and crosslinking of platelets (p515 col2 ¶2) and is used to record the assembly of a clot in whole blood (p513 ¶1). Also evidenced by Stravitz, prothrombin time is a standard test of coagulation which addresses plasmatic events in hemostasis (also evidenced by Stravitz p513 ¶1).
Thus a thromboelastography angle of more than 20 and a prothrombin time between 10-15 seconds, if measured, are properties of whole blood because whole blood comprises plasma and clotting factors, and the properties do not require additional process steps. Thus thromboelastography angle and prothrombin time have been interpreted as non-limiting.
However, if the factors were considered limiting, Delorme teach a stored blood product that is indistinguishable from the claimed composition (whole blood with platelets with oxygen saturation of 30% or less in an anticoagulant solution) and thus the blood product of Delorme would comprise the same properties as the claimed blood product, including a thromboelastography angle of more than 40 and a prothrombin time between 10-15 seconds, absent evidence to the contrary.
Regarding claim 97-100: The teachings of Delorme are discussed supra. Delorme is silent in regards to a platelet function that is equivalent or better than the platelet function in conventional stored non-oxygen reduced whole blood with platelets.
However, Delorme teach a stored blood product that is indistinguishable from the claimed composition (whole blood with platelets with oxygen saturation of 30% or less in an anticoagulant solution) and thus the blood product of Delorme would comprise the same properties as the claimed blood product, including platelet function that is equivalent or better than the platelet function in conventional stored whole blood with platelets, if additional process steps were performed to measure said function, absent to evidence to the contrary.
Regarding claim 101: The teachings of Delorme are discussed supra. Delorme is silent in regards to RBC deformability.
As evidenced by Cluitmans, red blood cells undergo extensive deformation when travelling through the microcapillaries (abstract), and thus red blood cell deformation is a property of red blood cells. Red blood cell deformability, if measured, is a property of the stored whole blood as taught by Delorme because the stored whole blood comprises red blood cells, and does not require additional process steps. Thus, red blood cell deformability is interpreted as non-limiting.
However, if red blood cell deformability were interpreted as limiting, Delorme teach a stored blood product that is indistinguishable from the claimed composition (whole blood with platelets with oxygen saturation of 30% or less in an anticoagulant solution) and thus the blood product would comprise the same properties as the claimed blood product, including higher RBC deformability compared to RBC deformability of conventionally stored whole blood, absent evidence to the contrary.
Thus, the teachings of Delorme anticipate Applicant’s 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.
Claims 103-104 are rejected under 35 U.S.C. 103 as being unpatentable over Yoshida(2012) et al. (US20120225416A1, on IDS 04/27/2021, hereafter “Yoshida(2012)”) as applied to claims 35, 49, 89, 93, 94, 97-102 and 105, and further in view of Murthi et al (Expert Rev Hematol (2008) 1(1):99-109, previously cited).
This is a new rejection that relies on art cited in a previous action.
Regarding claims 103 and 104: The teachings of Yoshida(2012) are discussed supra. Yoshida(2012) are silent on use of the blood product for a patient in need of multiple blood transfusions or a hemorrhagic patient.
Murthi teach common laboratory tests used in the management of transfusion decisions are thromboelastography, fibrinogen concentration (a clotting factor), and prothrombin time (p10 para 4/5 ln 1-3/1).
Murthi also teach most of the blood used in trauma care is to support patients with uncontrolled hemorrhage, and that patients who do not achieve definitive control of hemorrhage for many days may require multiple transfusions (p2 para 4 ln1-5; p9 para 4/5 ln 1/1).
It would have been prima facia obvious to one of ordinary skill in the art at the time of the invention to combine the teachings of Murthi with the disclosure of Yoshida(2012).
One of ordinary skill in the art would have been motivated to do so because Murthi teach common practices in the field of blood transfusion at the time of the invention, and the patients that would be in need thereof. It would have been common practice for blood to be used for transfusion to be assed using these parameters.
One of ordinary skill in the art would have had a reasonable expectation of success because the practices that Murthi teach are commonly used to asses blood for transfusion, and the disclosure of Yoshida(2012) teach blood for transfusion purposes. The patient populations for the disclosures, at the time of the disclosures would have been identical.
Thus the teachings of Yoshida(2012) and Murthi render obvious the invention as claimed.
Claims 49 and 89 are rejected under 35 U.S.C. 103 as being unpatentable over Yoshida(2012) et al. (US20120225416A1, on IDS 04/27/2021, hereafter “Yoshida(2012)”) as applied to claims 35, 49, 89, 93, 94, 97-102 and 105, and further in view of Scarpelini et al. (Braz J Med Biol (2009) 42(12) 1210-1217; previously cited).
This is a new rejection but relies previously cited prior art.
Regarding claims 49 and 89: The teachings of Yoshida(2012) are discussed supra.
While the coagulation parameters such as thromboelastography angle are not considered limiting, if they were considered limiting to the claim they would be obvious over the teachings in the prior art, as discussed below.
Yoshida(2012) is silent on the coagulation properties of the oxygen reduced stored whole blood with platelets and not teach that a thromboelastography angle is more than 40.
Scarpelini teach normal values of thromboelastography alpha angle for healthy volunteers is 47.8-77.7, and that the manufacturer’s reference values are 55-78 (p1213 Table 3).
MPEP 2131.03 reads “"[W]hen, as by a recitation of ranges or otherwise, a claim covers several compositions, the claim is ‘anticipated’ if one of them is in the prior art." Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985)”
MPEP 2131.03 reads “When the prior art discloses a range which touches or overlaps the claimed range, but no specific examples falling within the claimed range are disclosed, a case by case determination must be made as to anticipation. In order to anticipate the claims, the claimed subject matter must be disclosed in the reference with ‘sufficient specificity to constitute an anticipation under the statute.’”
MPEP 2131.03 further reads “If the prior art disclosure does not disclose a claimed range with "sufficient specificity" to anticipate a claimed invention, any evidence of unexpected results within the narrow range may render the claims nonobvious. See MPEP § 716.02 et seq.”.
In the case of the instant claim, the range disclosed by the prior art clearly overlaps with the claimed range. Therefore, in the in the absence of new or unexpected results for values outside the claimed range, the range disclosed by the cited Art is considered to disclose the claimed range with “sufficient specificity” to anticipate the claimed range.
It would have been prima facia obvious to one of ordinary skill in the at a the time of the invention to combine the teaching of Scarpelini with the composition of Yoshida(2012) to test the coagulation properties of the stored whole blood composition.
One of ordinary skill in the art would have been motivated to do so because normal clotting values, as assessed by thromboelastography, were a common metric for evaluating blood stored quality for transfusion and having normal clotting properties would be important for successful blood transfusion.
One of ordinary skill in the art would have had a reasonable expectation of success because thromboelastography values from anaerobically stored blood are a characteristic of the whole blood composition and is are not expected to change under anaerobic conditions, as the composition of whole blood does not change under anaerobic conditions.
Thus the teachings of Yoshida(2012) and Scarpelini render obvious the invention as claimed.
Claims 93, 94 and 97-100 are rejected under 35 U.S.C. 103 as being unpatentable over Yoshida(2012) et al. (US20120225416A1, on IDS 04/27/2021, hereafter “Yoshida(2012)”) as applied to claims 35, 49, 89, 93, 94, 97-102 and 105, and further in view of Pidcoke et al. (Transfusion(2013) 53(01)137S-149S.; previously cited).
This is a new rejection but relies previously cited prior art.
Regarding claims 93, 94 and 97-100: The teachings of Yoshida(2012) are discussed supra. While the platelet function and clotting parameters are interpreted supra as non-limiting, if they were considered limiting to the claim they would be obvious over the teachings in the prior art, as discussed below.
Pidcoke teach prothrombin time is a widely used measure of coagulation function, and prothrombin time of freshly collected whole blood is between 10-15 seconds (p9 para 2 ln1, Figure 7). Pidcoke also teach measurement of clotting factor v and aggregometry as measurements of platelet function (p3/4 paragraph 4/1).
It would have been prima facia obvious to one of ordinary skill in the art at the time of the invention to combine the teachings of Pidcoke with the composition of Yoshida(2012).
One of ordinary skill in the art would have been motivated to do so because Pidcoke discloses common tests for blood and platelet quality with normal parameters and blood used for transfusion should have quality metrics within the normal range in order to be safe for the recipient.
One of ordinary skill in the art would have had a reasonable expectation of success because the quality factors are based on the composition of whole blood, which is not expected to change under anaerobic storage conditions.
Thus the teachings of Yoshida(2012) and Pidcoke render obvious the invention as claimed.
Claims 103-104 are rejected under 35 U.S.C. 103 as being unpatentable over Delorme et al. (US 2015/0306288 A1) as applied above to claims 35, 49, 89, 93-94, 97-102 and 105, and further in view of Murthi et al (Expert Rev Hematol (2008) 1(1):99-109, previously cited).
This is a new rejection that relies on art cited in a previous action.
Regarding claims 103 and 104: The teachings of Delorme are discussed supra. Delorme are silent on use of the blood product for a patient in need of multiple blood transfusions or a hemorrhagic patient.
Murthi teach common laboratory tests used in the management of transfusion decisions are thromboelastography, fibrinogen concentration (a clotting factor), and prothrombin time (p10 para 4/5 ln 1-3/1).
Murthi also teach most of the blood used in trauma care is to support patients with uncontrolled hemorrhage, and that patients who do not achieve definitive control of hemorrhage for many days may require multiple transfusions (p2 para 4 ln1-5; p9 para 4/5 ln 1/1).
It would have been prima facia obvious to one of ordinary skill in the art at the time of the invention to combine the teachings of Murthi with the disclosure of Delorme.
One of ordinary skill in the art would have been motivated to do so because Murthi teach common practices in the field of blood transfusion at the time of the invention, and the patients that would be in need thereof. It would have been common practice for blood to be used for transfusion to be assed using these parameters.
One of ordinary skill in the art would have had a reasonable expectation of success because the practices that Murthi teach are commonly used to asses blood for transfusion, and the disclosure of Delorme teach blood for transfusion purposes. The patient populations for the disclosures, at the time of the disclosures would have been identical.
Thus the teachings of Delorme and Murthi render obvious the invention as claimed.
Response to Arguments
The responses are directed to the Arguments filed 09/18/2025.
Regarding Arguments directed to 35 USC § 112(b):
Applicant's arguments filed on 09/18/2025 have been fully considered and they are persuasive.
Claims 49 and 89 were rejected for reciting the trademark “TEG”.
Applicant submits amendments to claims 49 and 89 remove the phrases containing “TEG”.
This is found persuasive and the rejection is withdrawn.
Regarding Arguments directed to 35 USC § 102(a)(1) over Yoshida(2013):
Applicant's arguments filed on 09/18/2025 have been fully considered and they are persuasive.
Applicant submits Yoshida(2013) does not disclose oxygen depleted from whole blood, but is drawn to deoxygenation of packed red blood cells (p3).
This is found persuasive and the rejection is withdrawn. However a new rejection over 35 USC § 102(a)(1) is entered supra.
Regarding Arguments directed to 35 USC § 102(a)(1) over Delorme.
Applicant's arguments filed on 09/18/2025 have been fully considered but they not persuasive.
Applicant submits that Delorme fails to teach or disclose actively reducing oxygen from the whole placental blood. (p6 paragraph 2).
This is not persuasive because 1) the claim does not require the step of “actively reducing oxygen”. Furthermore, the claims are directed to a composition of oxygen reduced stored whole blood (instant claim 35) and as such, method steps limiting to the claim except in relation to the structure which they impart on the claimed composition.
MEPE § 2113 reads “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)”
Thus the oxygen depleted whole blood composition disclosed by Delorme reads on the claim as written and the rejection is maintained.
Regarding Arguments directed to 35 USC § 103 over Yoshida(2013) and Murthi.
The rejection is withdrawn in view of the withdrawn rejection (102(a)(1) over Yoshida(2013)) upon which the instant rejection relies.
A new rejection under USC § 103 is discussed supra, however, the arguments against Murthi are relevant to the new rejection and are addressed.
Applicant argues that Murthi is silent regarding oxygen depletion, much less the effects of oxygen depletion on platelets in whole blood (p8 paragraph 3).
In response to applicant’s arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Accordingly, the argument is found unpersuasive.
Regarding Arguments directed to 35 USC § 103 over Delorme in view of Murthi.
Applicant submits the Examiner has not established that a combination of Delorme, as evidenced by Bhattacharya, and Murthi teaches, suggests, or provides for all of the elements of the claims. However, as applicant does not present specific arguments to support the allegation, the argument is found unpersuasive and the rejection is maintained.
Regarding Arguments directed to 35 USC § 103 over Yoshida in view of Scarpelini.
The rejection is withdrawn in view of the withdrawn rejection (102(a)(1) over Yoshida(2013)) upon which the instant rejection relies.
A new rejection under USC § 103 is discussed supra, however, the arguments against Scarpelini are relevant to the new rejection and are addressed.
Applicant submits Scarpelini is silent with regard to oxygen depletion, much less the effects of oxygen depletion on platelets in whole blood.
In response to applicant’s arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Accordingly, the argument is found unpersuasive.
Conclusion
No claims are allowed.
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/ANDREA LYNNE MORRIS SPENCER/Examiner, Art Unit 1631
/JAMES D SCHULTZ/Supervisory Patent Examiner, Art Unit 1631