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 .
Detailed Action
Election/Restrictions
Applicant’s election without traverse of thromboelastography angle (TEG angle) (claims 49 and 89) as the first species for examination, and prothrombin time (PT) (claims 93 and 94) as the second species for examination, in the reply filed on 10/24/2024 is acknowledged.
Election was made without traverse in the reply filed on 10/25/2024.
Priority
The present application is a CON of 17241648, filed 04/27/2021.
Applicant' s claim for the benefit of a prior-filed parent provisional application 15575249, filed on 11/17/2017, PCT/US2016/033151 filed 05/18/2016 and 62163269 filed on 05/18/2015 under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged.
Thus, the earliest possible priority for the instant application is 05/18/2015.
Claims Status
Claims 1-34, 36-48, 50-88, 105-106 are canceled, claims 107-108 are newly added, claims 90-92, 95-96 have been withdrawn from consideration as being drawn to non-elected subject matter, and claims 35, 49, 89, 93-94, 97-104, and 107-108 have been considered on the merits. All arguments have been considered.
Withdrawn Objections & Rejections
Applicant's response filed 05/01/2026 has been considered. Rejections and/or objections not reiterated from the previous Office action mailed 02/03/2026 are hereby withdrawn.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 § 112 (New)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 103 and 104 rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Regarding claims 103 and 104: The claims are drawn to the stored oxygen and carbon dioxide reduced leukoreduced whole blood composition with platelets of claim 35. The claims recite wherein clauses drawn to a trauma patient in need of a transfusion of the blood product.
The wherein clauses do not impose or imply a structural limitation to the claimed product. The claimed product of claims 103 and 104 is therefore interpreted as “to the stored oxygen and carbon dioxide reduced leukoreduced whole blood composition with platelets” in the claim analysis.
MPEP 2111.02 II states “During examination, statements in the preamble reciting the purpose or intended use of the claimed invention must be evaluated to determine whether or not the recited purpose or intended use results in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art. If so, the recitation serves to limit the claim”.
While the intended use wherein clauses of claims 103 and 104 do not occur in the preamble of the claims, they serve the same purpose of reciting the purpose or intended use of the claimed invention and do not result in a structural difference between the claimed invention of claims 103-104 and claimed invention of claim 35.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102 (New)
Claims 35, 49, 89, 93, 94, 97-105 and 107-108 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)”; cited previously) as evidenced by Oxford Languages (retrieved from internet 03/31/2025; cited previously), Severinghaus (Journal of Applied Physiology, 46(3): 599-602, 1979; cited previously), Cluitmans et al (BioMed Research International (2014)1-9; cited previously).
This is a new rejection due to the claim amendments.
Regarding claims 35, 103-104: Claim 35 is drawn to a “stored oxygen and carbon dioxide reduced leukoreduced whole blood composition with platelets (OR-WB+PLT) for transfusion to a trauma patient in need thereof”.
The wherein clause “wherein transfusion of the stored OCR-LRWB+PLT does not induce coagulopathy in the trauma patient” (claim 35) and the phrase “for transfusion to a trauma patient in need thereof…” (claims 103-104) are considered intended use/intended results for which any composition which has the structure of the claimed composition would also produce the claimed result.
While the claim requires that this composition be “stored”, neither the claims 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 oxygen and carbon dioxide reduced leukoreduced whole blood composition with platelets” has been interpreted as whole blood that has been kept or accumulated for future use.
The claim recites that the whole blood composition is “leukoreduced” and is a composition “with platelets”. Thus the whole blood composition is required to have a reduced number of leukocytes and have platelets present in the composition.
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 process steps is storing. The claimed product-by-process is also leukoreduced and reduced in oxygen and carbon dioxide. Thus any whole blood composition that is leukoreduced, has a saturated oxygen (SO2) concentration of 30% or less, a CO2 partial pressure of less than 60mmHg, comprises platelets and is stored is considered to read on the composition as claimed.
Claims 103 and 104 do not impart structure to the claimed blood product beyond the structure disclosed in the parent claim because, as discussed above, the wherein clauses which recite characteristics of the intended recipient (intended use) of the whole blood composition of claim 35; are intended use phrases.
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 teach that blood is collected into a Leukotrap RC whole blood collection, filtration and storage system (p4 [0026]), and thus the blood composition of Yoshida reads on “leukoreduced” as required by the claim. Yoshida(2012) further discloses that the composition can be transfused to patients (paragraph [0022]).
Yoshida teach that the blood is stored for 9 weeks (p4 [0026]), which reads on “a storage period of at least three weeks” as required by the instant claim.
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 and carbon dioxide are reduced from the blood (p3 [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.
In regards to CO2 partial pressure, Yoshida disclose the carbon dioxide is depleted to approximately 5 mmHg (p2 [0015] claim 16), which reads on a partial of less than 60mmHg 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, carbon dioxide of less than 60mmHg 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, which do not impart structure on the claimed composition.
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 (a whole blood composition with a saturated oxygen (SO2) concentration of 30% or less, a CO2 partial pressure of less than 60mmHg, with platelets and is stored) 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 (a whole blood composition with a saturated oxygen (SO2) concentration of 30% or less, a CO2 partial pressure of less than 60mmHg, with platelets and is stored) 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 (a whole blood composition with a saturated oxygen (SO2) concentration of 30% or less, a CO2 partial pressure of less than 60mmHg, with platelets and is stored) 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.
Claim Rejections - 35 USC § 103 (New)
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 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, 97-105 and 107-108, and further in view of Scarpelini et al. (Braz J Med Biol (2009) 42(12) 1210-1217; previously cited).
Claims 35, 49, 89, 93, 94, 97-105 and 107-108 are anticipated by Yoshida and thus are also rendered obvious (see above).
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, 97-105 and 107-108 and further in view of Pidcoke et al. (Transfusion(2013) 53(01)137S-149S.; previously cited).
Claims 35, 49, 89, 93, 94, 97-105 and 107-108 are anticipated by Yoshida and thus are also rendered obvious (see above).
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.
Response to Arguments
The responses are directed to the Arguments filed 05/01/2026, all arguments are considered.
Regarding Arguments directed to 35 USC § 102:
Regarding Yoshida:
The amendments to the claims overcome the rejection as written. Specifically the amendments introduce new limitations that had not been addressed by the previous rejection; “oxygen and carbon dioxide reduced”, “leukoreduced”, “partial pressure of carbon dioxide of less than 60 mmHg”, “storage period of at least three weeks under oxygen and carbon dioxide reduced conditions”.
The rejection is withdrawn.
In response to arguments relevant to the new rejection:
In regards to Applicants argument that Yoshida do not teach (1) stored OCR-LRWB+PLT having an SO2 of 30% or less and a partial pressure of carbon dioxide of less than 60 mmHg, having been a storage period of at least three weeks under oxygen and carbon dioxide reduced conditions, and having one or more coagulation parameters that are equivalent to or greater than the same one or more coagulation parameters in conventionally stored non-OCR-LRWB+PLT, and (2) transfusion of the stored OCR-LRWB+PLT does not induce coagulopathy in a trauma patient, as recited in claim 35; Applicant’s attention is directed to the new rejection under 102 in which the new limitations to the amended claims are addressed.
In summary; regarding the new limitation of carbon dioxide reduced conditions with a partial pressure of carbon dioxide less than 60 mmHg; Yoshida disclose the carbon dioxide is depleted to approximately 5 mmHg (p2 [0015] claim 16), which reads on a partial pressure of less than 60mmHg.
Regarding coagulation parameters and does not induce coagulopathy in a trauma patient; these limitations are considered an intended result for which any composition which has the structure of the claimed composition would also produce the claimed result.
Regarding a storage period of at least three weeks, while this is not considered to impart structure on the claimed composition, Yoshida do teach that the blood composition is stored for 9 weeks (p4 [0026]), which reads on “a storage period of at least three weeks”
In response to Applicants argument that Yoshida removes the platelet rich plasma from the blood composition and thus the composition does not meet the limitation “with platelets” as required: Applicant presupposes that Yoshida removes 100% of the platelets when isolating the platelet rich plasma and thus the composition of Yoshida does not read on a blood composition with platelets as required by claim 35.
While Yoshida do collect and discard the platelet rich plasma (p4 [0026]), as evidenced by Dhurat, isolation of platelet rich plasma recovers (removes) at best 80% of platelets from a sample (p193 col1 ¶3). Therefore the blood composition of Yoshida would retain at least 20% platelets and is thus reads on a “composition with platelets” as required by the claim. See Dhurat et al (Journal of Cutaneous and Aesthetic Surgery (2014) 7:4; 189-197).
Thus the argument that Yoshida removes 100% of the platelets when isolating the platelet rich plasma from the blood composition is unpersuasive and the composition of Yoshida is considered to read on a blood composition with platelets.
Applicant argues that Yoshida is silent on coagulation parameters and makes no mention of trauma patients. As discussed in the previous and instant rejection, the wherein clause “wherein transfusion of the stored OCR-LRWB+PLT does not induce coagulopathy in the trauma patient” is considered an intended result for which any composition which has the identical structure as the claimed composition would also produce the claimed result.
Applicant argues generally against the theory of inherency based on the statement that Yoshida do not teach limitations of the stored blood product and thus the product would not comprise the same properties of the claimed blood product.
MPEP 2112.01 reads “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). ‘When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985)’”.
The composition of Yoshida comprises the identical structure to the claimed composition and therefore also would have the same properties as the claimed composition, absent evidence to the contrary.
The new limitations introduced by the amendments are 1) carbon dioxide reduced conditions with a partial pressure of carbon dioxide less than 60 mmHg; 2) Leukoreduced; and 3) wherein transfusion of the blood composition does not induce coagulopathy.
The limitations are addressed in the new rejection supra and a summary of the response pertaining to the specific limitations is as follows:
1) Regarding carbon dioxide reduced conditions with a partial pressure of carbon dioxide less than 60 mmHg: Yoshida disclose the carbon dioxide is depleted to approximately 5 mmHg (p2 [0015] claim 16), which reads on a partial pressure of less than 60mmHg.
2) Regarding leukoreduced: Yoshida teach that blood is collected into a Leukotrap RC whole blood collection, filtration and storage system (p4 [0026]), and thus the blood composition of Yoshida reads on “leukoreduced”.
3) Regarding wherein transfusion of the blood composition does not induce coagulopathy: The phrase “wherein transfusion of the stored OCR-LRWB+PLT does not induce coagulopathy in the trauma patient” (claim 35) is considered and intended result for which any composition which has the structure of the claimed composition would also produce the claimed result.
4) Regarding the limitation “stored” and “a storage period of at least three weeks”: It is noted that “storing” is a process step. 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).
“Storing” is not considered to impart structure on the claimed composition, however Yoshida teach that the blood is stored for 9 weeks (p4 [0026]), which reads on “a storage period of at least three weeks”.
Regarding Dolorme:
The amendments to the claims overcome the rejection as written. Specifically the amendments introduce new limitations that had not been addressed by the previous rejection; “oxygen and carbon dioxide reduced”, “leukoreduced”, “partial pressure of carbon dioxide of less than 60 mmHg”, “storage period of at least three weeks under oxygen and carbon dioxide reduced conditions”.
The rejection is withdrawn.
A new rejection over Dolorme is not entered.
Regarding Arguments directed to 35 USC § 103:
Regarding Yoshida in view of Murthi:
Applicant essentially argues that Murthi is silent regarding the new limitations added to the claims in the instant amended claim set; whole blood with platelets that are oxygen reduced, carbon dioxide reduced, and leukoreduced. These limitations upon are addressed by Yoshida in the new rejection above.
Furthermore, Applicant argues against limitations for which Murthi is not relied upon. 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).
Regarding Yoshida in view of Scarpelini:
Applicant essentially argues that Scarpelini is silent regarding the new limitations added to the claims in the instant amended claim set; whole blood with platelets that are oxygen reduced, carbon dioxide reduced, and leukoreduced. These limitations upon are addressed by Yoshida in the new rejection as discussed above.
Furthermore, Applicant argues against limitations for which Scarpelini is not relied upon. 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).
Regarding Yoshida in view of Pidcoke:
Applicant essentially argues that Pidcoke is silent regarding the new limitations added to the claims in the instant amended claim set; whole blood with platelets that are oxygen reduced, carbon dioxide reduced, and leukoreduced. These limitations upon are addressed by Yoshida in the new rejection as discussed above.
Furthermore, Applicant argues against limitations for which Pidcoke is not relied upon. 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).
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/ANDREA LYNNE MORRIS SPENCER/Examiner, Art Unit 1631
/JAMES D SCHULTZ/Supervisory Patent Examiner, Art Unit 1631
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