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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 12/13/2023 and 2/21/2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 112
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 1-20 are 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 1 recites the limitation “a second bag in fluid communication with the first bag and not the separation bag”. It is unclear how the second bag can be in fluid communication with the first bag and not the separation bag, as having the first and second bag in fluid communication would indirectly provide fluid communication between the second bag and the separation bag. For the purpose of this examination, this limitation has been interpreted as meaning the second bag receives fluid from the first bag and not from the second bag during use.
Claims 2-17 are similarly rejected as they depend upon rejected claim 1.
Claim 2 recites the limitation “a third bag in fluid communication with the separation bag and not the first bag or second bag”. It is unclear how the third bag can be in fluid communication with the separation bag and not the first or second bag, as having the third bag in fluid communication with the separation bag would indirectly provide fluid communication between the third bag and first or second bag. For the purpose of this examination, this limitation has been interpreted as meaning the third bag receives fluid from the separation bag and not from the first or second bag during use.
Claims 3-16 are similarly rejected as the depend upon rejected claim 2.
Claim 3 recites the limitation “a fourth bag in fluid communication with the separation bag and not the first bag or the second bag or the third bag”. It is unclear how the fourth bag can be in fluid communication with the separation bag and not the first, second, or third bag, as having the fourth bag in fluid communication with the separation bag would indirectly provide fluid communication between the fourth bag and the first, second, or third bag. For the purpose of this examination, this limitation has been interpreted as meaning the fourth bag receives fluid from the separation bag and not from the first, second, or third bag during use.
Claims 4-16 are similarly rejected as they depend upon rejected claim 3.
Claim 5 recites the limitation “a fifth bag in fluid communication with the separation bag and not the first bag or the second bag or the third bag”. It is unclear how the fifth bag can be in fluid communication with the separation bag and not the first, second, or third bag, as having the fourth bag in fluid communication with the separation bag would indirectly provide fluid communication between the fourth bag and the first, second, or third bag. For the purpose of this examination, this limitation has been interpreted as meaning the fifth bag receives fluid from the separation bag and not from the first, second, or third bag during use.
Claims 6-11 are similarly rejected as the depend upon rejected claim 5.
Claim 18 recites the limitations “a second bag in fluid communication with the first bag and not the separation bag”, “a third bag in fluid communication with the separation bag and the first bag or the second bag”, “a fourth bag in fluid communication with the separation bag and not the first bag, the second bag, or the third bag”, and “a fifth bag in fluid communication with the separation bag and not the first bag, the second bag, the third bag, or the fourth bag”. These limitations are unclear because the bags as described are indirectly fluidically connected with each other. For the purpose of this examination, this limitations have been interpreted as a second bag receives fluid from the first bag and not from the second bag during use; a third bag receives fluid from the separation bag and from the first or second bag during use; a fourth bags receives fluid from the separation bag and not from the first, second, or third bags during use; and a fifth bag receives fluid from the separation bag and not from the first, second, third, or fourth bags during use.
Claims 19-20 are similarly rejected as the depend upon rejected claim 18.
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.
Claims 1-3 and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Holmes et al. (US 2004/0104182 A1) (see PTO-892).
Regarding claim 1, Holmes et al. discloses a disposable bag set (abstract; [0102], lines 25-27 – disposable set) for separating discrete volumes of a composite fluid (abstract), the disposable bag set comprising:
a separation bag (Fig. 3, separation bag 11 – see annotated figure below) including the composite fluid to be separated ([0062], lines 1-5);
a first bag (Fig. 3, second component collection container 14) in fluid communication with the separation bag (Fig. 3 shows fluid connection via second tube 15), the first bag configured to receive a first component of the composite fluid from the separation bag ([0074], lines 15-17 disclose receiving component from separation bag; [0018], lines 3-4 and 18 - buffy coat, red blood cells or platelets); and
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a second bag (Fig. 3, satellite bag 75) in fluid communication with the first bag and not the separation bag (Fig. 3 shows that satellite bag receives fluid from container 14 and not separation bag 11; see claim 1 112(b) rejection for claim interpretation), the configured to receive a product formed using the first component ([0111] discloses the product is the filtered second component).
Regarding claim 2, Holmes et al. discloses the disposable bag set of claim 1.
Holmes et al. further discloses wherein the disposable bag set further includes: a third bag (Fig. 3, third product collection bag 24 – see annotated figure below) in fluid communication with the separation bag and not the first bag or second bag (Fig. 3 shows that bag 24 receives fluid from the separation bag and not bags 14 or 75; see claim 2 112(b) rejection for claim interpretation), the third bag configured to receive a second component of the composite fluid from the separation bag ([0074], lines 15-17), the second component being different from the first component and the product ([0018], lines 7-8 and 16-17).
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Regarding claim 3, Holmes et al. discloses the disposable bag set of claim 2.
Holmes et al. further discloses wherein the disposable bag set further includes: a fourth bag (Fig. 3, first component collection container 12 – see annotated figure below) in fluid communication with the separation bag and not the first bag or the second bag or the third bag (Fig. 3 shows that receives fluid from the separation bag and not bags 14, 75, or 24; see claim 3 112(b) rejection for claim interpretation), the fourth bag configured to receive a third component of the composite fluid from the separation bag ([0074], lines 15-16), the third component being different from the first component, the second component, and the product
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([0018], lines 18-19).
Regarding claim 17, Holmes et al. discloses the disposable bag set of claim 1.
Holmes et al. further discloses wherein a tube length establishes fluid communication between the first bag and the second bag (Fig. 3 shows line 77 connecting second component collection container 14 (i.e., first bag) and satellite bag 75 (i.e., second bag) – see annotated figure below).
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Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 4 is rejected under 35 U.S.C. 103 as being obvious over Holmes et al. (US 2004/0104182 A1) (already referenced) in view of Nguyen et al. (US 2011/0312481 A1) (see PTO-892).
Regarding claim 4, Holmes et al. discloses the disposable bag set of claim 3.
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Holmes et al. further discloses a collection of tubes connecting the separation bag to the first bag, the second bag, and the fourth bag (Fig. 3 shows tubes/lines 13, 15, and 77 connecting bags 12, 14, and 24 to the separation bag 11 – see annotated figure below) but fails to teach wherein the tube lengths establish fluid communication between the bags and a connector.
However, Nguyen et al. discloses:
a first tube length (Fig. 1, first tube 18 – see annotated figure below) establishing fluid communication between the separation bag and a connector (Fig. 1 shows tube 18 connecting separation bag 12 to x connector 34);
a second tube length (Fig. 1, plasma collection tube 32) establishing fluid communication between the connector and the first bag (Fig. 1 shows tube 32 connecting a first bag 14 and x connector 34);
a third tube length (Fig. 1, tube 46) establishing fluid communication between the connector and the third bag (Fig. 1 shows tube 46 connecting a third bag 44 and x connector 34); and
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a fourth tube length (Fig. 1, tube 36) establishing fluid communication between the connector and the fourth bag (Fig. 1 shows tube 36 connecting a fourth bag 16 and x connector 34).
It would have been obvious to one of ordinary skill in the art to modify the apparatus of Holmes et al. to incorporate the tube lengths and connector of Nguyen et al. because it would facilitate the flow of the separated components from the separation bag to the component bags.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the teachings of Holmes et al. and Nguyen et al. to obtain the invention as specified in claim 4.
Claims 5-7 are rejected under 35 U.S.C. 103 as being obvious over Holmes et al. (US 2004/0104182 A1) (already referenced).
Regarding claim 5, Holmes et al. discloses the disposable bag set of claim 3, but fails to teach wherein the disposable bag set further includes: a fifth bag in fluid communication with the separation bag and not the first bag or the second bag or the third bag, the fifth bag configured to receive a fourth component of the composite fluid from the separation bag, the fourth component being different form the first component, the second component, the third component, and the product.
However, Holmes et al. teaches whole blood is separated into plasma, red blood cells, platelets ([0011], lines 11-12), and white blood cell components ([0096], lines 43-45 teaches whole blood separation can further separate white blood cells) and that bags can be used to collect components of whole blood ([0060]).
It would have been obvious to one of ordinary skill in the art to modify the apparatus of Holmes et al. to include fifth bag in fluid communication with the separation bag and not the first bag or the second bag or the third bag, configured to receive a fourth component of the composite fluid from the separation bag, the fourth component being different form the first component, the second component, the third component, and the product to collect all components of the blood (plasma, red blood cells, platelets, and white blood cells).
Further, it has been held that the duplication of parts has no patentable significance unless a new and unexpected result is produced (MPEP §2144.04 VI B). It would have been obvious to one of ordinary skill in the art to modify the apparatus disclosed by Holmes et al. to comprise a fifth bag configured to receive a fourth component of the composite fluid from the separation bag, as such a modification represents mere duplication of the first through fourth bags, and would provide the predictable outcome of duplicating the bag, which the skilled artisan would readily recognize as desirable to collect the fourth product.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the apparatus and teachings of Holmes et al. to obtain the invention as specified in claim 5.
Regarding claim 6, modified Holmes et al. teaches the disposable bag set of claim 5.
Holmes et al. fails to teach wherein a tube length establishes fluid communication between the separation bag and the fifth bag, the tube length including one of a clamp and a filter, the clamp configured to move between an open position and a closed position, and in the close position, the clamp is configured to at least partially occlude movement through the tube length.
However, Holmes et al. teaches it is known in the art to use a tube length to establish fluid communication between two bags (see claim 1 rejection), including one of a clamp ([0014], lines 14-19; [0070] discloses pinch valves (i.e., clamps) can be on tubes between all bags) and a filter (Fig. 3, filter 73), the clamp configured to move between an open position and a closed position ([0096], lines 1-6 disclose pinch valves are capable of moving between an open and a closed position), and in the close position, the clamp is configured to at least partially occlude movement through the tube length.
It would have been obvious to one of ordinary skill in the art to further modify the disposable bag set of Holmes et al. to include a pinch valve (i.e., clamp) and a filter, as taught by Holmes et al., on a tube length between the separation bag and the fifth bag because the clamp would control flow from the separation bag to the fifth bag and the filter would prevent contaminants from collecting in the fifth bag.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the disposable bag set and teachings of Holmes et al. to obtain the invention as specified in claim 6.
Regarding claim 7, modified Holmes et al. teaches the disposable bag set of claim 6.
Holmes et al. further discloses wherein a filter may be a red blood cell leukoreduction filter ([0019], lines 17-18).
Claims 8-11 are rejected under 35 U.S.C. 103 as being obvious over Holmes et al. (US 2004/0104182 A1) (already referenced) in view of Corash et al. (US 2018/0318348 A1) (see PTO-892).
Regarding claim 8, modified Holmes et al. teaches the disposable bag set of claim 5.
Holmes et al. further discloses wherein the composite fluid includes whole blood ([0011], lines 3-5) and the first component includes plasma ([0011], lines 10-12 - the blood is separated into components, including plasma; [0018], lines 18-19 - an intended use of the first bag of modified Holmes et al. may be for receiving a first plasma component), but fails to teach wherein the product formed using the first component includes cryoprecipitate.
However, Corash et al. teaches it is known in the art to use plasma to form cryoprecipitate. Corash et al. teaches a bag set (Fig. 1A, processing set 100 – see annotated figure below) comprising a first bag containing plasma (Fig. 1A, plasma bag 102) in fluid communication with a second bag for the purpose of forming cryoprecipitate (Fig. 1A, larger bag 124; fluid communication via elements 104, 106, 110, 108, and 126; [0180], lines 16-17 discloses freezing plasma to form cryoprecipitate) and that cryoprecipitate is used for
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therapeutic applications ([0004], lines 19-23).
It would have been obvious to one of ordinary skill in the art to further modify the disposable bag set of Holmes et al. such that the second bag receives a cryoprecipitate product formed using the plasma of the first bag, as taught by Corash et al., so that the cryoprecipitate may be used for therapeutic applications.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the disposable bag set and teachings of modified Holmes et al. and the teachings of Corash et al. to obtain the invention as specified in claim 8.
Regarding claim 9, modified Holmes et al. teaches the disposable bag set of claim 8.
Holmes et al. further discloses wherein the second component includes platelets ([0018], lines 15-19).
Regarding claim 10, modified Holmes et al. teaches the disposable bag set of claim 9.
Modified Holmes et al. further teaches wherein a third component of whole blood includes white blood cells (see claim 5 rejection). The fourth bag of modified Holmes et al. would be fully capable of receiving the white blood cells (i.e., residual leukocytes) because it receives a component of whole blood ([0074], lines 15-16).
Regarding claim 11, modified Holmes et al. teaches the disposable bag set of claim 10.
Holmes et al. further teaches wherein a fourth component of whole blood includes red blood cells ([0011], lines 11-12). The fifth bag of modified Holmes et al. would be fully capable of receiving red blood cells because the bags can receive a component of whole blood ([0074], lines 15-17).
Claims 12-16 are rejected under 35 U.S.C. 103 as being obvious over Holmes et al. (US 2004/0104182 A1) (already referenced) in view of Sano (US 2011/0238030 A1) (referenced in IDS).
Regarding claim 12, modified Holmes et al. teaches the disposable bag set of claim 3, but fails to teach a sixth bag.
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However, Sano teaches a blood bag system for treating and separating blood (abstract) with a separation bag (Fig. 1, first bag 1, i.e., separation bag – see annotated figure below) in fluid communication with a testing blood bag (Fig. 1, testing blood bag 12, i.e., sixth bag, connected to first bag 1 via blood collecting tube 11) configured to aid in the collection of blood, i.e., a composite fluid ([0042]).
It would have been obvious to one of ordinary skill in the art to further modify the disposable bag set of Holmes et al. to include a sixth bag in fluid communication with the separation bag, as taught by Sano, for the purpose of providing whole blood directly from a donor to the separation bag for eventual treatment or separating.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the teachings of Holmes et al. and Sano to obtain the invention as specified in claim 12.
Regarding claim 13, modified Holmes et al. teaches the disposable bag set of claim 12.
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Modified Holmes et al. further teaches via Sano, wherein the disposable bag set further includes: a collection of tubes connecting the separation bag to the sixth bag (Fig. 1, tubes between bags 1 and 12 – see annotated figure below), the collection of tubes including: a first tube length establishing fluid communication between the separation bag and a connector (Fig. 1, tube length between 1 and y-connector); and a second tube length establishing fluid communication between the sixth bag and the connector (Fig. 1, tube length between 12 and y-connector), the connector being joined to a needle (Fig. 1, y-connector joined to needle 10, where needle is for collecting blood; [0042]).
It would have been obvious to one of ordinary skill in the art to further modify the disposable bag set of Holmes et al. to include a connector, a first tube between the separation bag and the connector, a second tube between the sixth bag and the connector, and a needle joined to the connector, as taught by Sano, because the connector would facilitate the tubes and needle, the tubes would allow the movement of whole blood from the sixth bag to the separation bag for processing, and the needle would extract the whole blood for processing.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the disposable bag set and the teachings of Holmes et al. and Sano to obtain the invention as specified in claim 13.
Regarding claim 14, modified Holmes et al. teaches the disposable bag set of claim 13, but fails to teach wherein the first tube length includes a clamp, the clamp configured to move between an open position and a closed position, and in the close position, the clamp is configured to at least partially occlude movement through the first tube length.
However, Holmes et al. teaches wherein the tubes connecting bags in a bag set may be engaged by one or more pinch valves (i.e., clamps) ([0014], lines 14-19; [0070]) to control flow (i.e., movement) through the tubes by moving between an open and closed position ([0096], lines 1-6).
It would have been obvious to one of ordinary skill in the art to further modify the disposable bag set of Holmes et al. to include a clamp at the first tube length because it would control flow through the first tube length.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the teachings of Holmes et al. and Sano to obtain the invention as specified in claim 14.
Regarding claim 15, modified Holmes et al. teaches the disposable bag set of claim 13, but fails to teach wherein the second tube length includes a clamp, the clamp configured to move between an open position and a closed position, and in the close position, the clamp is configured to at least partially occlude movement through the first tube length.
However, Holmes et al. teaches wherein the tubes connecting bags in a bag set may be engaged by one or more pinch valves (i.e., clamps) ([0014], lines 14-19; [0070]) to control flow (i.e., movement) through the tubes by moving between an open and closed position ([0096], lines 1-6).
It would have been obvious to one of ordinary skill in the art to further modify the disposable bag set of Holmes et al. to include a clamp at the second tube length because it would control flow through the second tube length.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the teachings of Holmes et al. and Sano to obtain the invention as specified in claim 15.
Regarding claim 16, modified Holmes et al. teaches the disposable bag set of claim 13.
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Modified Holmes et al. further teaches via Sano, wherein the collection of tubes further includes: a needle injury protector disposed between the connector and the needle (Fig. 1, mis-stick preventive implement 13 – see annotated figure below).
It would have been obvious to one of ordinary skill in the art to further modify the disposable bag set of Holmes et al. to include a needle injury protector disposed between the connector and the needle to prevent mis-sticks during use.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the disposable bag set and teachings of Holmes et al. and Sano to obtain the invention as specified in claim 16.
Claim 18 is rejected under 35 U.S.C. 103 as being obvious over Nguyen et al. (US 2011/0312481 A1) (already referenced) in view of Corash et al. (US 2018/0318348 A1) (already referenced).
Regarding claim 18, Nguyen et al. discloses a disposable bag set (Fig. 1, set of bags – see annotated figure below) for separating whole blood ([0024], lines 1-3), the disposable bag set comprising:
a separation bag including the whole blood to be separated (Fig. 1, separation bag 12; [0024], lines 1-3 disclose whole blood);
a first bag in fluid communication with the separation bag (Fig. 1, first component bag 14), the first bag configured to receive a plasma from the whole blood held by the separation bag ([0027], lines 1-2);
a third bag in fluid communication with the separation bag and the first bag or the second bag (Fig. 1, second component bag 16 in fluid communication with separation bag 12 and first bag 14 via tubes 18, 32, and 36), the third bag configured to received platelets from the whole blood held by the separation bag ([0027], lines 4-6);
a fourth bag in fluid communication with the separation bag and not the first bag, the second bag, or the third bag (Fig. 1, discard bag 44 receives fluid from separation bag 12 and not bags 14 or 16; see claim 18 112(b) rejection for claim interpretation), the fourth bag configured to receive residual leukocytes from the whole blood held by the separation bag ([0028], lines 13-16); and
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a fifth bag in fluid communication with the separation bag and not the first bag, the second bag, the third bag, or the fourth bag (Fig. 1, third component bag 38 receives fluid from separation bag 12 and not bags 14, 16, or 44; see claim 18 112(b) rejection for claim interpretation), the fifth bag configured to receive red blood cells from the whole blood held by the separation bag ([0027], lines 11-12).
Nguyen et al. fails to teach the second bag in fluid communication with the first bag and not the separation bag, the second bag configured to receive cryoprecipitate formed using the plasma.
However, Corash et al. teaches a processing set (i.e., disposable bag set) with a plasma bag (i.e., first bag) in fluid communication with a larger bag (i.e., second bag), the larger bag configured to receive cryoprecipitate formed using the plasma (Fig. 1, processing set 100,
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plasma bag 102, larger bag 124 – see annotated figure below; [0180] teaches cryoprecipitate formed using plasma).
Corash et al. teaches that cryoprecipitate is used for therapeutic applications ([0004], lines 19-23).
It would have been obvious to one of ordinary skill in the art to modify the bag set of Nguyen et al. to include a second bag in fluid communication with the first bag and not the separation bag, as taught by Corash et al. to receive cryoprecipitate formed using the plasma for therapeutic applications.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the disposable set and teachings of Nguyen et al. and Corash et al. to obtain the invention as specified in claim 18.
Claim 19-20 are rejected under 35 U.S.C. 103 as being obvious over Nguyen et al. (US 2011/0312481 A1) (already referenced) as modified by Corash et al. (US 2018/0318348 A1) (already referenced) as applied to claim 18 above, and in further view of Sano (US 2011/0238030 A1) (already referenced).
Regarding claim 19, modified Nguyen et al. teaches the disposable bag set of claim 18, but fails to teach wherein the disposable bag set further includes: a sixth bag in fluid communication with the separation bag and configured to aid in the collection of the whole blood.
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However, Sano teaches a blood bag system for treating and separating blood (abstract) with a first bag (Fig. 1, first bag 1, i.e., separation bag – see annotated figure below) in fluid communication with a testing blood bag (Fig. 1, testing blood bag 12, i.e., sixth bag, connected to first bag 1 via blood collecting tube 11) configured to aid in the collection of blood ([0042]).
It would have been obvious to one of ordinary skill in the art to further modify the disposable bag set of Nguyen et al. to incorporate the sixth bag, as taught by Sano, because it would provide the whole blood for separation to the separation bag.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the disposable bag set and teachings of Nguyen et al., Corash et al., and Sano to obtain the invention as specified in claim 19.
Regarding claim 20, modified Nguyen et al. teaches the disposable bag set of claim 19.
Nguyen et al. further teaches wherein the disposable bag set further includes: a first collection of tubes connecting the separation bag to the first bag, the second bag, and the fourth bag, the first collection of tubes including:
a first tube length establishing fluid communication between the separation bag and a connector (Fig. 1, first tube 18 connects separation bag 12 and x connector 34);
a second tube length establishing fluid communication between the connector and the first bag (Fig. 1, plasma collection tube 32 connects x connector 34 and first bag);
a third tube length establishing fluid communication between the connector and the third bag (Fig. 1, platelet collection tube 36 connects x connector 34 and third bag); and
a fourth tube length establishing fluid communication between the connector and the fourth bag (Fig. 1, discard tube 46 connects x connector 34 and fourth bag);
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a fifth tube length establishing fluid communication between the separation bag and the fifth bag (Fig. 1, third tube 22 connects separation bag 12 and fifth bag);
Nguyen et al. fails to teach a sixth tube length establishing fluid communication between the first bag and the second bag; and a second collection of tubes connecting the separation bag to the sixth bag, the second collection of tubes including: a first tube length establishing fluid communication between the separation bag and a connector; and a second tube length establishing fluid communication between the sixth bag and the connector, the connector being joined to a needle.
However, Corash et al. teaches it is known in the art to use a tube length to connect blood processing bags to establish fluid communication between two bags and Nguyen et al. as modified by Corash et al. teaches the second bag in fluid communication (see claim 18 rejection).
Corash et al. teaches tubing between multiple bags which facilitates the transfer of plasma between the bags ([0180]).
It would have been obvious to one of ordinary skill in the art to further modify the disposable bag set of Nguyen et al. to incorporate a tube length between the first and second bag, as taught by Corash et al., thus establishing fluid communication for the transfer of plasma.
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Further, Sano et al. teaches a collection of tubes (Fig. 1 – see annotated figure below), including a first tube length establishing fluid communication between the separation bag and a connector (Fig. 1, blood collecting tube 11 connects separation bag and y-connector); and a second tube length establishing fluid communication between the sixth bag and the connector (Fig. 1 shows a tube connecting y-connector and testing blood bag 12), the connector being joined to a needle (Fig. 1, blood collecting needle 10 joined to needle). Nguyen et al. as modified by Sano teaches the sixth bag in fluid communication with the separation bag (see claim 19 rejection).
It would have been obvious to one of ordinary skill in the art to further modify the disposable bag set of Nguyen et al. to incorporate a second collection of tubes including: a first tube length establishing fluid communication between the separation bag and a connector; and a second tube length establishing fluid communication between the sixth bag and the connector, the connector being joined to a needle because the connector would facilitate the tubes and needle, the tubes would allow the movement of whole blood from the sixth bag to the separation bag for processing, and the needle would extract the whole blood for processing.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the disposable bag set and teachings of Nguyen et al., Corash et al., and Sano to obtain the invention as specified in claim 20.
Conclusion
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/A.J.C./ Examiner, Art Unit 1799
/William H. Beisner/ Primary Examiner, Art Unit 1799