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 .
Response to Arguments
Applicant’s amendment filed 10/09/2025 is accepted and entered. Applicant’s amendments to the claims have overcome the previous claim objections and the previous claim objections have been withdrawn.
Applicant’s arguments, see Remarks pages 8-10, filed 10/09/2025, with respect to the rejection(s) of claim(s) 1, 11, 17, and 22 under USC 102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Mahal/Hiranuma, as set forth below.
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(s) 1-20 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Mahal (EP 0138147 A2) in view of Hiranuma et al (JP 2004-089495; citations reference the translation supplied by Applicant with the 10/09/2025 IDS).
Regarding Claim 1, Mahal discloses a disposable fluid circuit (10, Fig. 1) for processing a biological fluid (pg. 1 lines 5-9) comprising:
an access device (donor needle, pg. 6 lines 14-24) for withdrawing blood from a blood source (pg. 6 lines 14-24), said access device being in openable flow communication with one or more containers (12, Fig. 1) for receiving blood or a blood component (pg. 6 lines 14-24), said one or more containers (12, Fig. 1) comprising first and second sealed together walls (pg. 9 lines 3-20) defining an interior chamber for holding blood or a blood component (pg. 1 lines 5-9, pg. 9 lines 3-20), wherein at least one of said first and second walls includes a surface facing said interior chamber comprising:
a polymeric composition comprising approximately 57-64% wt. of polyvinyl chloride (pg. 9 lines 14-20; the example bags created with 65 parts of BTHC calculate to 58.3% wt. of PVC; if the bags are created with 60 parts of BTHC the calculation comes out to 60% wt. of PVC, and bags created with 50 parts of BTHC would have 63.9% wt. of PVC); and
approximately 50-60 phr of a citrate ester consisting essentially of n-butyryl-tri-hexyl citrate (pg. 9 lines 14-20 indicates the example bags are made with 65 phr of BTHC; pg. 7 lines 8-13 indicate the total plasticizer in the composition can be between 20-60% by weight; the example bags made with 65 phr BTHC have 37.9% wt. of BTHC, bags made with 60 phr BTHC would have 36% wt. of BTHC, and bags made with 50 phr BTHC would have 31.9% BTHC (see below tables for calculations) which is within the preferred range for plasticizer amount).
Component
PHR (parts per hundred)
% wt (component PHR / total PHR) X 100
PVC
100
58.3%
BTHC
65
37.9%
ESO
5
2.9%
Ca-Zn
1
.5%
Mineral oil
0.5
.3%
Totals
171.5
99.9%
Component
PHR (parts per hundred)
% wt(component PHR / total PHR) x 100
PVC
100
60%
BTHC
60
36%
ESO
5
3%
Ca-Zn
1
.6%
Mineral oil
0.5
.3%
Totals
166.5
99.9%
Component
PHR (parts per hundred)
% wt (component PHR / total PHR) x 100
PVC
100
63.9%
BTHC
50
31.9%
ESO
5
3.2%
Ca-Zn
1
.6%
Mineral oil
0.5
.3%
Totals
156.5
99.9%
While Mahal discloses using 20-60% plasticizer in the PVC (pg. 7 lines 8-13), with a specific example of 65 phr of the BTHC plasticizer which calculates to 37.9% wt. BTHC, Mahal does not explicitly disclose approximately 50-60 phr of the BTHC. Mahal is also silent whether the blood or blood component exhibits a hemolysis level of less than 0.4% after at least 42 days of storage within said one or more containers.
Hiranuma teaches a system for blood processing, thus being in the same field of endeavor, with a red blood cell storage bag (20, Fig. 1) that is made of PVC and BTHC at 52 phr (pg. 22 lines 7-11). This gives the bag excellent plasticity and strength, and the plasticizer is safer for living organisms than other plasticizers (pg. 9 line 9 – pg. 10 line 6).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the amount of BTHC in the bag of Mahal to be 52 phr as taught by Hiranuma since that this amount of BTHC in a blood bag results in excellent plasticity and strength while being safer for living organisms than other plasticizers (as motivated by Hiranuma pg. 9 line 9 – pg. 10 line 6). The combination of Mahal/Hiranuma would have the following composition:
Component
PHR (parts per hundred)
% wt (component PHR / total PHR) x 100
PVC
100
63.1%
BTHC
52
32.8%
ESO
5
3.1%
Ca-Zn
1
.6%
Mineral oil
0.5
.3%
Totals
158.5
99.9%
Mahal/Hiranuma is silent whether the blood or blood component exhibits a hemolysis level of less than 0.4% after at least 42 days of storage within said one or more containers. However, it has been held that 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, it would be understood that the bag of Mahal/Hiranuma would result in the blood or blood component exhibiting a hemolysis level of less than 0.4% after at least 42 days of storage within said one or more containers.
Regarding Claim 11, Mahal discloses a container (12, Fig. 1) for the storage of red blood cells (pg. 6 lines 14-24) comprising first and second sealed together walls (pg. 9 lines 3-20) defining an interior chamber for holding red blood cells (pg. 1 lines 5-9, pg. 9 lines 3-20), wherein at least one of said first and second walls includes a surface facing said interior chamber comprising a composition comprising:
a resin comprising approximately 57-64% wt. of polyvinyl chloride (pg. 9 lines 14-20; the example bags created with 65 parts of BTHC calculate to 58.3% wt. of PVC; if the bags are created with 60 parts of BTHC the calculation comes out to 60% wt. of PVC, and bags created with 50 parts of BTHC would have 63.9% wt. of PVC); and
approximately 50-60 phr of a citrate ester consisting essentially of n-butyryl-tri-hexyl citrate (pg. 9 lines 14-20 indicates the example bags are made with 65 phr of BTHC; pg. 7 lines 8-13 indicate the total plasticizer in the composition can be between 20-60% by weight; the example bags made with 65 phr BTHC have 37.9% wt. of BTHC, bags made with 60 phr BTHC would have 36% wt. of BTHC, and bags made with 50 phr BTHC would have 31.9% BTHC (see above tables for calculations) which is within the preferred range for plasticizer amount).
While Mahal discloses using 20-60% plasticizer in the PVC (pg. 7 lines 8-13), with a specific example of 65 phr of the BTHC plasticizer which calculates to 37.9% wt. BTHC, Mahal does not explicitly disclose approximately 50-60 phr of the BTHC. Mahal is also silent whether the blood or blood component exhibits a hemolysis level of less than 0.4% after at least 42 days of storage within said one or more containers.
Hiranuma teaches a system for blood processing, thus being in the same field of endeavor, with a red blood cell storage bag (20, Fig. 1) that is made of PVC and BTHC at 52 phr (pg. 22 lines 7-11). This gives the bag excellent plasticity and strength, and the plasticizer is safer for living organisms than other plasticizers (pg. 9 line 9 – pg. 10 line 6).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the amount of BTHC in the bag of Mahal to be 52 phr as taught by Hiranuma since that this amount of BTHC in a blood bag results in excellent plasticity and strength while being safer for living organisms than other plasticizers (as motivated by Hiranuma pg. 9 line 9 – pg. 10 line 6). The combination of Mahal/Hiranuma has a composition as shown above in the rejection of Claim 1.
Mahal/Hiranuma is silent whether the blood or blood component exhibits a hemolysis level of less than 0.4% after at least 42 days of storage within the container. However, it has been held that 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, it would be understood that the bag of Mahal/Hiranuma would result in the blood or blood component exhibiting a hemolysis level of less than 0.4% after at least 42 days of storage within said one or more containers.
Regarding Claim 17, Mahal discloses a red blood cell product (pg. 6 line 14 – pg. 7 line 6) comprising a container (12, Fig. 1) comprising first and second sealed together walls (pg. 9 lines 3-20) defining an interior chamber for holding red blood cells (pg. 1 lines 5-9, pg. 9 lines 3-20), wherein at least one of said first and second walls includes a surface facing said interior chamber comprising a composition comprising:
a resin comprising approximately 57-64% wt. of polyvinyl chloride (pg. 9 lines 14-20; the example bags created with 65 parts of BTHC calculate to 58.3% wt. of PVC; if the bags are created with 60 parts of BTHC the calculation comes out to 60% wt. of PVC, and bags created with 50 parts of BTHC would have 63.9% wt. of PVC); and
approximately 50-60 phr of a citrate ester consisting essentially of n-butyryl-tri-hexyl citrate (pg. 9 lines 14-20 indicates the example bags are made with 65 phr of BTHC; pg. 7 lines 8-13 indicate the total plasticizer in the composition can be between 20-60% by weight; the example bags made with 65 phr BTHC have 37.9% wt. of BTHC, bags made with 60 phr BTHC would have 36% wt. of BTHC, and bags made with 50 phr BTHC would have 31.9% BTHC (see above tables for calculations) which is within the preferred range for plasticizer amount).
While Mahal discloses using 20-60% plasticizer in the PVC (pg. 7 lines 8-13), with a specific example of 65 phr of the BTHC plasticizer which calculates to 37.9% wt. BTHC, Mahal does not explicitly disclose approximately 50-60 phr of the BTHC. Mahal is also silent whether the red blood cells exhibit an average hemolysis level of less than 0.4% after 42 days of storage.
Hiranuma teaches a system for blood processing, thus being in the same field of endeavor, with a red blood cell storage bag (20, Fig. 1) that is made of PVC and BTHC at 52 phr (pg. 22 lines 7-11). This gives the bag excellent plasticity and strength, and the plasticizer is safer for living organisms than other plasticizers (pg. 9 line 9 – pg. 10 line 6).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the amount of BTHC in the bag of Mahal to be 52 phr as taught by Hiranuma since that this amount of BTHC in a blood bag results in excellent plasticity and strength while being safer for living organisms than other plasticizers (as motivated by Hiranuma pg. 9 line 9 – pg. 10 line 6). The combination of Mahal/Hiranuma has a composition as shown above in the rejection of Claim 1.
Mahal/Hiranuma is silent whether the red blood cells exhibit an average hemolysis level of less than 0.4% after 42 days of storage. However, it has been held that 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, it would be understood that the bag of Mahal/Hiranuma would result in the red blood cells exhibiting an average hemolysis level of less than 0.4% after 42 days of storage.
Regarding Claim 22, Mahal discloses a plasma product (pg. 6 line 14 – pg. 7 line 6) comprising a container (18 or 20, Fig. 1) comprising first and second sealed together walls (pg. 9 lines 3-20) defining an interior chamber for holding plasma (pg. 1 lines 5-9, pg. 9 lines 3-20) that can be frozen, wherein at least one of said first and second walls includes a surface facing said interior chamber comprising a composition comprising:
a resin comprising approximately 57-64% wt. of polyvinyl chloride (pg. 9 lines 14-20; the example bags created with 65 parts of BTHC calculate to 58.3% wt. of PVC; if the bags are created with 60 parts of BTHC the calculation comes out to 60% wt. of PVC, and bags created with 50 parts of BTHC would have 63.9% wt. of PVC); and
approximately 50-60 phr of a citrate ester consisting essentially of n-butyryl-tri-hexyl citrate (pg. 9 lines 14-20 indicates the example bags are made with 65 phr of BTHC; pg. 7 lines 8-13 indicate the total plasticizer in the composition can be between 20-60% by weight; the example bags made with 65 phr BTHC have 37.9% wt. of BTHC, bags made with 60 phr BTHC would have 36% wt. of BTHC, and bags made with 50 phr BTHC would have 31.9% BTHC (see above tables for calculations) which is within the preferred range for plasticizer amount).
While Mahal discloses using 20-60% plasticizer in the PVC (pg. 7 lines 8-13), with a specific example of 65 phr of the BTHC plasticizer which calculates to 37.9% wt. BTHC, Mahal does not explicitly disclose approximately 50-60 phr of the BTHC.
Hiranuma teaches a system for blood processing, thus being in the same field of endeavor, with a red blood cell storage bag (20, Fig. 1) that is made of PVC and BTHC at 52 phr (pg. 22 lines 7-11). This gives the bag excellent plasticity and strength, and the plasticizer is safer for living organisms than other plasticizers (pg. 9 line 9 – pg. 10 line 6).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the amount of BTHC in the bag of Mahal to be 52 phr as taught by Hiranuma since that this amount of BTHC in a blood bag results in excellent plasticity and strength while being safer for living organisms than other plasticizers (as motivated by Hiranuma pg. 9 line 9 – pg. 10 line 6). The combination of Mahal/Hiranuma has a composition as shown above in the rejection of Claim 1.
Mahal/Hiranuma is silent whether the plasma within said interior chamber has a Factor VIII activity, fibrinogen level, post-storage recover of IgG and fibrinogen level, and a post-storage recovery of von Willibrand factor antigen and Factors II, V, VIII, IV, and XI levels claimed. However, it has been held that 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 modified storage product of Mahal/Hiranuma as set forth above would display the claimed Factor VIII activity, fibrinogen level, post-storage recover of IgG and fibrinogen level, and a post-storage recover of von Willibrand factor antigen and Factors II, V, VIII, IV, and XI levels after freezing and thawing as the modified storage product of Mahal/Hiranuma has the same composition as the claimed product.
Regarding Claims 2 and 9, Mahal is silent regarding a leukoreduction filter located between a container for receiving whole blood from said blood source and a second container, and further comprising a third container in openable flow communication with said second container.
Hiranuma teaches a leukoreduction filter (50, Fig. 1) located between a container for receiving whole blood (blood collection bag 10, Fig. 1) from said blood source (152, Fig. 1) and a second container (red blood cell bag 20, Fig. 1), and further comprising a third container (plasma storage bag 30, Fig. 1) in openable flow communication with said second container (20, Fig. 1). This allows the system to be used for blood collection and separation procedures (pg. 4 lines 3-9 of Detailed Description).
Therefore, it would have been obvious to modify the system of Mahal/Hiranuma to include a leukoreduction filter located between a container for receiving whole blood from said blood source and a second container, and further comprising a third container in openable flow communication with said second container, as taught by Hiranuma to allow the system to be used for blood collection and separation procedures (as motivated by Hiranuma pg. 4 lines 3-9 of Detailed Description).
Regarding Claims 3-5, 12-14, and 20, Mahal further discloses said composition further comprises an epoxidized oil (pg. 7 lines 15-26, pg. 9 lines 3-20), wherein said epoxidized oil comprises epoxidated soybean oil (pg. 7 lines 15-26, pg. 9 lines 3-20) or epoxidated linseed oil (pg. 7 lines 15-26).
Regarding Claims 6, 15, and 19, the combination of Mahal/Hiranuma discloses the composition consisting essentially of 29%-36% wt. of BTHC (as seen above in the rejection of Claim 1, the combination of Mahal/Hiranuma has 32.8% of BTHC).
Regarding Claims 7 and 16, Mahal further discloses said composition further comprises one or more stabilizers, co-stabilizers, and slip agents (pg. 7 lines 15-26, pg. 9 lines 3-20).
Regarding Claim 8, Mahal/Hiranuma is silent whether the ratio of epoxidized oil to n-butyryl-tri-hexyl citrate is between 1:3 and 1:10.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the weight percent of the epoxidized oil and the weight percent of the BTHC of Mahal/Hiranuma such that the ratio of the epoxidized oil to BTHC is between 1:3 and 1:10 as applicant appears to have placed no criticality on the claimed range (see ¶ [0012] of Applicant’s published specification indicating the bags “may” be made with a plastic composition including a ratio of epoxidized oil to BTHC within the claimed range) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding Claim 10, the Mahal/Hiranuma teaches the claimed invention substantially as claimed as set forth above for Claim 9.
Mahal/Hiranuma further discloses wherein each of said container for receiving whole blood (Mahal 12, Fig. 1 / Hiranuma 10, Fig. 1), second container (Mahal 18, Fig. 1 / Hiranuma 20, Fig. 1) and third container (Mahal 20, Fig. 1 / Hiranuma 30, Fig. 1) comprises first and second sealed together walls defining an interior for holding blood or a blood component (Mahal pg. 6 lines 14-24), wherein at least one of said first and second walls includes a surface facing said interior chamber comprising the claimed weight percentage of polyvinyl chloride and the claimed parts per hundred of citrate ester consisting essentially of n-butyryl-tri-hexyl (Mahal pg. 9 lines 3-20 indicates all bags of the blood donation system are made of the same material).
Regarding Claim 18, Mahal further discloses a synthetic storage medium (pg. 8 lines 19-35).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jessica Arble whose telephone number is (571)272-0544. The examiner can normally be reached Mon - Fri 9 AM - 5 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at 571-272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JESSICA ARBLE/ Primary Examiner, Art Unit 3781