DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 8/20/2026 has been entered.
Response to Arguments
Claim 2 has been cancelled in the amendments to the claims filed 8/20/2026.
The claim amendments dated 8/20/2026 have overcome the rejection under 35 U.S.C. 112(b) presented in the prior Office Action.
Applicant’s arguments with respect to claims 1 and 3-20 filed 8/20/2026 have been considered but are moot in view of a new grounds of rejection necessitated by the amendments to the claims.
Specification
The disclosure is objected to because of the following informalities:
In [0062] of the specification filed 9/13/2023, elements first connector and second connector are both assigned part number 704 in lines 8 and 11.
In [0062] of the specification filed 9/13/2023, element first connector is assigned part numbers 704 and 712.
Additionally, the specification appears to contradict itself with respect to the first bag, second bag, third bag, fourth bag, fifth bag, first component, second component, third component, fourth component, and fifth component. The specification filed 9/13/2023 describes the elements of note differently in the SUMMARY section and the DETAILED DESCRIPTION section. See examples below:
Regarding the first bag and the first component, see at least [0023], “The first bag may be configured to receive a plasma” and [0059], “The first component may include platelets and the first bag 602 may be a platelet collection bag”.
Regarding the second bag and the second component, see at least [0023], “The second bag may be configured to receive cryoprecipitate” and [0059], “The second component may include plasma and the second bag 612 may be a plasma collection bag”.
Regarding the third bag and third component, see at least [0023], “The third bag may be configured to received platelets” and [0059], “the third component may be cryoprecipitate prepared from plasma and the third bag 622 may be a plasma cryoprecipitate bag or a plasma cryoprecipitate reduced bag”.
Regarding the fifth bag, fourth bag, fourth component, and fifth bag see at least [0010], “The fifth bag may be configured to receive a fourth component”, [0016], “the fourth component includes red blood cells”, [0023], “The fifth bag may be configured to receive red blood cells”, and [0061], “The fifth bag 642 may be configured to receive and store a fifth component…the fifth component may include leukocytes and the fifth bag 642 may be a residual leukocyte bag 642”.
Appropriate correction is required.
Claim Interpretation
The phrase using the connector in claims is interpreted as the connector being along a path of fluid communication.
The phrase not using the connector is interpreted as the connector not being along a path of fluid communication.
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 and 3-20 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.
Regarding claim 1, the claim is rejected as it appears inconsistent with the specification (see objection to the specification above). A claim, although clear on its face, may also be indefinite when a conflict or inconsistency between the claimed subject matter and the specification disclosure renders the scope of the claim uncertain (MPEP § 2173.03).
Additionally, the limitation “a third bag in fluid communication with the separation bag and not the second bag” renders the claim indefinite in light of the specification. The limitation appears inconsistent with the specification disclosure (see Fig. 4 in the drawings filed 9/13/2023 showing that the third bag 622 and second bag 612 are connected, also see [0059] in the written disclosure filed 9/13/2023). All bags are shown to be connected in some manner in Fig. 4 of the drawings filed 9/13/2023. Therefore, all bags appear to be in fluid communication with one another.
Clarification/correction is requested.
Claim 13 recites the limitation "the second connector" in line 9. There is insufficient antecedent basis for this limitation in the claim.
Further regarding claim 13, it is unclear if the element “a connector” in line 7 refers to the first connector recited earlier in the instant claim (line 2) or the second connector recited later in the instant claim (line 9).
Regarding claim 16, it is unclear if the element “the connector” in line 3 refers to the first connector or second connecter recited in claim 13. For examination on the merits, the connector in claim 16 will be interpreted as the second connecter.
Regarding claim 18, the claim is rejected as it appears inconsistent with the specification (see objection to the specification above). A claim, although clear on its face, may also be indefinite when a conflict or inconsistency between the claimed subject matter and the specification disclosure renders the scope of the claim uncertain (MPEP § 2173.03). Clarification/correction is requested.
Dependent claims are rejected for the same reason(s) as the base claim(s) upon which they depend.
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, 3-4, 12-13, and 16-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sano (US 2011/0238030 A1) (already of record – presented in IDS filed 2/21/2024).
Regarding claim 1, Sano discloses a disposable bag set (abstract, blood bag system) for separating discrete volumes of a composite fluid, the disposable bag set comprising:
a separation bag (Fig. 2, first bag 1 – see annotated figure below) including the composite fluid to be separated ([0041]);
a first bag in fluid communication with the separation bag (Fig. 2, second bag 2), the first bag configured to receive a first component of the composite fluid from the separation bag ([0046]);
a second bag in fluid communication with the first bag (Fig. 2, fourth bag 4), the second bag configured to receive fluid directly from the first bag and not directly from the separation bag ([0048]), the second bag configured to receive a product formed using the first component; ([0048]);
a third bag in fluid communication with the separation bag and not the second bag (Fig. 2, third bag 3), the third bag configured to receive a second component of the composite fluid from the separation bag, the second component being different from the first component and the product; and
a connector establishing the fluid communication between the separation bag and the first bag and between the separation bag and the third bag (Fig. 2).
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The limitations “configured to receive a first component of the composite fluid from the separation bag”, “configured to receive a product formed using the first component”, and “configured to receive a second component of the composite fluid from the separation bag” are directed toward the intended manner of operating the claimed first bag, second bag, and third bag, and do not differentiate the claimed structures from the corresponding prior art structures because all structural limitations are taught in the prior art (MPEP § 2114 II). The prior art first bag would be fully capable of achieving its claimed intended use because it is connected to the separation bag and can receive fluid (Fig. 2; [0046]). The prior art second bag would be fully capable of achieving its claimed intended use because it is connected to the first bag and can receive fluid (Fig. 2; [0048]). The prior art third bag would be fully capable of achieving its claimed intended use because it is connected to the separation bag and can receive fluid (Fig. 2; [0047]).
The limitation “the second component being different from the first component and the product” is directed towards the material or article worked upon by the claimed apparatus and does not limit the claim which it depends upon (MPEP § 2115).
Regarding claim 3, Sano discloses the disposable bag set of claim 1, wherein the disposable bag set further includes:
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a fourth bag in fluid communication with the separation bag using the connector (Fig. 2 – see annotated figure below), the fourth bag configured to receive a third component of the composite fluid from the separation bag, the third component being different from the first component, the second component, and the product.
The limitation “configured to receive a third component of the composite fluid from the separation bag” is directed toward the intended manner of operating the claimed structure and does not differentiate the claimed element from the corresponding prior art element because all structural limitations are taught in the prior art (MPEP § 2114 II).
The limitation “the third component being different from the first component, the second component, and the product” is directed towards the material or article worked upon by the claimed apparatus and does not limit the claim which it depends upon (MPEP § 2115).
Regarding claim 4, Sano discloses the disposable bag set of claim 3, wherein the disposable bag set further includes:
a collection of tubes connecting the separation bag to the first bag, the second bag, and the fourth bag, the collection of tubes including:
a first tube length establishing fluid communication between the separation bag and the connector (Fig. 2: 15);
a second tube length establishing fluid communication between the connector and the first bag (Fig. 2: 16 or tube with associated with 22);
a third tube length establishing fluid communication between the connector and the third bag (Fig. 2: 17); and
a fourth tube length establishing fluid communication between the connector and the fourth bag (Fig. 2: 19).
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Regarding claim 12, Sano discloses the disposable bag set of claim 3, wherein the disposable bag set further includes a sixth bag in fluid communication with the separation bag not using the connector and configured to aid in the collection of the composite fluid (Fig. 2 – see annotated figure below).
The limitation “configured to aid in the collection of the composite fluid” is directed toward the intended manner of operating the claimed sixth bag and does not differentiate the claimed structure from the corresponding prior art structure because all structural limitations are taught in the prior art (MPEP § 2114 II). The prior art sixth bag would be fully capable of achieving every claimed intended use because the prior art sixth bag is configured to collect blood ([0042]).
Regarding claim 13, Sano discloses the disposable bag set of claim 12, wherein the connector is a first connector; and
the disposable bag set further includes:
a collection of tubes connecting the separation bag to the sixth bag, the collection of tubes including:
a first tube length establishing fluid communication between the separation bag and a connector (Fig. 2 – see annotated figure below); and
a second tube length establishing fluid communication between the sixth bag and the second connector, the second connector being joined to a needle (Fig. 2 – see annotated figure below).
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Regarding claim 16, Sano discloses the disposable bag set of claim 13, wherein the collection of tubes further includes: a needle injury protector disposed between the connector and the needle (Fig. 2, mis-stick preventive implement 13 between connector and needle 10 – see above).
Regarding claim 17, Sano discloses the disposable bag set of claim 1, wherein a tube length establishes fluid communication between the first bag and the second bag (Fig. 2, tube 17 – see above).
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.
Claims 5-11 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Sano in view of Dolecek (US 2011/0003675 A1) (see PTO-892).
Regarding claim 5, Sano discloses the disposable bag set of claim 3.
Sano does not disclose or teach a fifth bag in fluid communication with the separation bag not using the connector.
However, Dolecek in the analogous art of blood processing teaches it was known in the art to connect a bag not using a connector for the purpose of collecting a blood component (Fig. 1, third component bag 38 not connected using connector 34 or 48).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to improve Sano’s disposable bag set to further comprise a fifth bag for the purpose of collecting a blood component, as Dolecek teaches that such an improvement was known in the art.
The limitation “configured to receive a fourth component of the composite fluid from the separation bag” is directed toward the intended manner of operating the claimed fifth bag and does not differentiate the claimed structure from the corresponding prior art structure because all structural limitations are taught in the prior art (MPEP § 2114 II). The bag taught by the prior art combination would be fully capable of achieving every claimed intended use because it can collect a blood component (Dolecek: [0022]).
The limitation “the fourth component being different form the first component, the second component, the third component, and the product” is directed towards the material or article worked upon by the claimed apparatus and does not limit the claim which it depends upon (MPEP § 2115).
Regarding claim 6, the prior art combination teaches the disposable bag set of claim 5.
Dolecek of the prior art combination discloses 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 (Fig. 1 shows a tube 22, clamp 86, and filter 40; [0053] discloses 86 is a valve, i.e., a clamp).
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 prior art combination bag set to comprise a tube length, the tube length including one of a clamp and a filter, because Dolecek teaches that such modifications are known in the art, and that the improvements are known in the art. In this case, Dolecek teaches it is known that a tube length establishes fluid communication between two bags, that a clamp can be used to control fluid flow through the tube length, and that a filter can be used to filter blood flowing through the tube length.
The limitation “configured to move between an open position and a closed position” is directed toward the intended manner of operating the claimed clamp and does not differentiate the claimed structure from the corresponding prior art structure because all structural limitations are taught in the prior art (MPEP § 2114 II). The prior art combination clamp would be fully capable of achieving every claimed intended use because the prior art structure is substantially identical to the claimed structure absent clear evidence to the contrary and absent a showing of unexpected results (MPEP § 2112.01 I).
The limitation “configured to at least partially occlude movement through the tube length” is a limitation contingent on closing of the clamp and has been given appropriate patentable weight (MPEP § 2111.04 II). No further prior art rejections are required as all structure necessary to meet the claim is taught and/or anticipated by the prior art of record.
Regarding claim 7, the prior art combination teaches the disposable bag set of claim 6, wherein the filter is a red blood cell leukoreduction filter (Dolecek: [0038]).
Regarding claims 8-11, the prior art combination teaches the disposable bag set of claim 5, wherein the composite fluid includes whole blood (Sano: [0041]).
The limitations with respect to the first, second, third, and fourth component, as well as the product, are directed towards the material or article worked upon by the claimed apparatus and do not limit the claim which it depends upon (MPEP § 2115).
Regarding claim 18, Sano discloses a disposable bag set for separating whole blood, the disposable bag set comprising: a separation bag, a first bag, a second bag, a third bag, and a fourth bag (including associated limitations) as claimed in claim 18, set forth above (see claims 3 and 8-11 rejection under 35 U.S.C. 103).
Sano does not disclose or teach a fifth bag as claimed in claim 5.
However, Dolecek discloses a fifth bag as claimed in claim 18, set forth above (see claim 5 rejection under 35 U.S.C. 103).
Regarding claim 19, the prior art combination teaches the disposable bag set of claim 18, wherein the disposable bag set further includes a sixth bag (including associated limitations) as claimed in claim 19, set forth above (see claim 13 rejection under 35 U.S.C. 103).
Regarding claim 20, the prior art combination teaches the disposable bag set of claim 19, as well as additional structure and limitations as claimed in claim 20, set forth above (see claims 4 and 13 rejection under 35 U.S.C. 103).
Claims 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Sano.
Regarding claim 14 and 15, Sano discloses the disposable bag set of claim 13.
Sano does not explicitly disclose wherein the first tube length or the second tube length includes a clamp.
However, Sano teaches that using a clamp on a tube length was known in the art (Fig. 2, clamps 22, 17a, 23 – see figure above).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Sano to further comprise a clamp included on the first tube length and second tube length for the purpose of controlling fluid flow, and the ordinarily skilled artisan would be motivated to prevent backflow from other bags.
The limitation “configured to move between an open position and a closed position” is directed toward the intended manner of operating the claimed clamp and does not differentiate the claimed structure from the prior art structure because all structural limitations are taught in the prior art (MPEP § 2114 II). The prior art clamp would be fully capable of achieving every claimed intended use because the prior art structure is substantially identical to the claimed structure absent clear evidence to the contrary and absent a showing of unexpected results (MPEP § 2112.01 I).
The limitation “configured to at least partially occlude movement through the first tube length” is a limitation contingent on the closing of the clamp and has been given appropriate patentable weight (MPEP § 2111.04 II). No further prior art rejections are required as all structure necessary to meet the claim is taught and/or anticipated by the prior art of record.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ADRIAN J CARREON whose telephone number is (571)272-6818. The examiner can normally be reached Monday - Friday 8:30 AM - 5 PM.
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/A.J.C./Examiner, Art Unit 1799
/William H. Beisner/Primary Examiner, Art Unit 1799
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