DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
Claims 1-20 are pending and examined on the merits.
Claims 1, 8, and 15 are currently amended.
Response to Amendment
Applicant’s amendments filed 12/03/2025 have been fully considered.
Claim Objections:
Applicant amended claim 1 to correct a typographical error. Accordingly, the objections to claims 1-7 are hereby withdrawn.
Response to Arguments
Applicant provided amendments to the independent claims which necessitates a new ground of rejection. Accordingly, Applicant’s arguments filed 12/03/2025 have been fully considered but they are moot. Specifically, Gewecke (U.S. Patent No. 3,087,491 A) is introduced as a new secondary reference in the present rejection for disclosing and rendering obvious the limitations presented via the amendments. Holmes (U.S. Pre Grant Pub. No. 2018/0304000 A1) remains as a primary reference in the present rejection for disclosing and rendering obvious some of the limitations presented in the claims.
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 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Holmes (U.S. Pre Grant Pub. No. 2018/0304000 A1) in view of Gewecke (U.S. Patent No. 3,087,491 A).
Regarding claim 1, Holmes teaches: A fluid component collection bladder (see blood component collection bladder 536 in Fig. 5A and para. [0150]) comprising:
a flexible sheet comprising a first layer (536A in Fig. 5D and para. [0178]) parallel with a second layer (536B in Fig. 5D and para. [0178]), the first and second layers each comprising a first end (540B in Fig. 5B and para. [0173]) and a second end distal to the first end (540A in Fig. 5B and para. [0173]) and a top end (at seal 554A in Fig. 5C) and a bottom end distal to the top end (at seal 554B in Fig. 5C);
a first permanent seal (see upper bladder seal 554A in Fig. 5C and para. [0178-0179]) joining the top end of the first layer and the top end of the second layer (see para. [0179]);
a second permanent seal joining the first end of the first layer and the second end of the second layer (as shown in Fig. 5B and as described in para. [0173], fluid component collection bladder 536 comprises a second permanent seal at the first end of the first layer at bladder free end 540B and at the second end of the second layer at bladder loop end 540A, which define a closed bladder capable of containing blood such that blood flowing within the first chamber 544 flows into the second chamber 552 when the flow reaches flow chamber transition 548 at bladder free end 540B and flows into and out of connector 532 as the blood flow reaches bladder loop end 540 A; fluid flowing in a direction from the bladder loop end 540A to the bladder free end 540B along the first collection flow chamber 544 may reach a flow chamber transition 548 and enter the second collection flow chamber 552; para. [0176] teaches that blood component collection bladder 536 may be formed, heat sealed from multiple layers of material, formed from a single layer of material folded onto itself, and/or combinations thereof); and
a third permanent seal (see flow chamber separator 542 in Figs. 5B-C and para. [0175]) joining a portion of the first layer and a parallel portion of the second layer to define first and second chambers of the fluid component collection bladder (see para. [0175]; first collection flow chamber 544 may be separated from the second collection flow chamber 552 via a flow chamber separator 542 which may be a heat sealed portion of the blood component collection bladder 536), wherein the third permanent seal extends from the first ends towards the second ends of the first and second layers (see Fig. 5B showing seal 542 extending from bladder loop end 540A towards bladder free end 540B) and a gap exists between the third permanent seal and the second permanent seal (see flow chamber transition 548 in Fig. 5B), the portion of the first layer and the parallel portion of the second layer are disposed between the respective top ends and bottom ends of the first and second layers, a first space between the tops of the first and second layers and the third permanent seal define the first chamber (see first collection flow chamber 544 in Fig. 5B), and a second space between the bottoms of the first and second layers and the third permanent seal define the second chamber (see second collection flow chamber 552 in Fig. 5B).
However, Holmes fails to explicitly teach at least one of the first layer and the second layer includes one or more permanent creases that extend between the top end and the bottom end of the respective layer, as required by the claim.
Gewecke teaches an analogous fluid collection container (see col. 1, lines 25-29) comprising a sheet comprising creases for preferential or directionalized folding (see col. 5, line 72 thru col. 6, line 9).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Holmes to incorporate the teachings of Gewecke by including one or more permanent creases that extend between the top end and the bottom end of the first layer or the second layer at least in order for preferential or directionalized folding, as taught by Gewecke (see col. 5, line 72 thru col. 6, line 9).
Regarding claim 2, Holmes in view of Gewecke teaches the invention as discussed above in claim 1. Additionally, Holmes teaches wherein the fluid component collection bladder further comprises: a fourth permanent seal (see lower bladder seal 554B in Fig. 5C) that joins the bottom end of the first layer and the bottom end of the second layer (see para. [0179]).
Regarding claim 3, Holmes in view of Gewecke teaches the invention as discussed above in claim 2. Additionally, Holmes teaches wherein the flexible sheet is a continuous sheet (see para. [0178]).
Regarding claim 4, Holmes in view of Gewecke teaches the invention as discussed above in claim 1. Additionally, Holmes teaches wherein the portion of the first layer and the parallel portion of the second layer are a first distance from the top ends of the first and second layers, and a second distance from the bottom ends of the first and second layers, wherein the second distance is greater than the first distance (as shown in Fig. 5B, the second collection flow chamber 552 is larger than the first collection flow chamber 544 because the flow chamber separator 542, which defines the portion of the first layer and the parallel portion of the second layer, is closer in distance to the top ends than the bottom ends of the first and second layers).
Regarding claim 5, Holmes in view of Gewecke teaches the invention as discussed above in claim 1. Additionally, Holmes teaches wherein the fluid component collection bladder further comprises a connector (filler loop connector 532 in Fig. 5B) disposed at and joined to the second ends of the first and second layers (as shown in Fig. 5B, connector 532 is disposed at and joined to the second ends of the first and second layers at bladder loop end 540A; see also para. [0173].
Regarding claim 6, Holmes in view of Gewecke teaches the invention as discussed above in claim 5. Additionally, Holmes teaches wherein the connector comprises a first flowpath aligned with the first chamber (see para. [0173]), and a second flowpath aligned with the second chamber (see para. [0173]).
Regarding claim 7, Holmes in view of Gewecke teaches the invention as discussed above in claim 5. Additionally, Holmes teaches wherein the connector comprises one or more alignment features (see second connector location feature 530B in Fig. 5B and para. [0177]; see also para. [0181]).
Regarding claim 8, Holmes teaches: A fluid component collection bladder (see blood component collection bladder 536 in Fig. 5A and para. [0150]) comprising:
a continuous flexible sheet (see para. [0178]) defining a first chamber (see first collection chamber 544 in Fig. 5B) between a top end of the fluid component collection bladder (at seal 554A in Fig. 5C) and a flow chamber separator (542 in Figs. 5B-C), and
a second chamber (see second collection flow chamber 554A in Fig. 5C) between a bottom end (at 554B in Fig. 5C) and the flow chamber separator (542), the flow chamber separator extending from a first end (see bladder loop end 540A in Fig. 5B) of the fluid component collection bladder towards a second end (see bladder free end 540B in Fig. 5B) of the fluid component collection bladder and a gap (see flow chamber transition 548 in Fig. 5B) existing between the fluid component collection bladder and the second end of the fluid component collection bladder (see Fig. 5B).
However, Holmes fails to explicitly teach the continuous flexible sheet including one or more permanent creases that extend between the top end and the bottom end, as required by the claim.
Gewecke teaches an analogous fluid collection container (see col. 1, lines 25-29) comprising a sheet comprising creases for preferential or directionalized folding (see col. 5, line 72 thru col. 6, line 9).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Holmes to incorporate the teachings of Gewecke by including on the continuous flexible sheet one or more permanent creases that extend between the top end and the bottom end at least in order for preferential or directionalized folding, as taught by Gewecke (see col. 5, line 72 thru col. 6, line 9).
Regarding claim 9, Holmes in view of Gewecke teaches the invention as discussed above in claim 8. Additionally, Holmes teaches wherein the flow chamber separator is a first permanent seal (see para. [0175]), and the fluid component collection bladder further comprises a second permanent seal (at 554A in Fig. 5C) defining the top end of the fluid component collection bladder (see para. [0179]).
Regarding claim 10, Holmes in view of Gewecke teaches the invention as discussed above in claim 9. Additionally, Holmes teaches wherein the flow chamber separator further comprises a third permanent seal defining the second end of the fluid component collection bladder (see Fig. 5B and para. [0173, 0176]).
Regarding claim 11, Holmes in view of Gewecke teaches the invention as discussed above in claim 8. Additionally, Holmes teaches wherein the fluid component collection bladder further comprises a connector (see filler loop connector 532 in Fig. 5B) disposed at and joined to first end of the fluid component collection bladder (see Fig. 5B and para. [0173]).
Regarding claim 12, Holmes in view of Gewecke teaches the invention as discussed above in claim 11. Additionally, Holmes teaches wherein the connector comprises a first flowpath aligned with the first chamber (see para. [0173]), and a second flowpath aligned with the second chamber (see para. [0173]).
Regarding claim 13, Holmes in view of Gewecke teaches the invention as discussed above in claim 12. Additionally, Holmes teaches wherein the connector comprises one or more alignment features (see second connector location feature 530B in Fig. 5B and para. [0177, 0181]).
Regarding claim 14, Holmes in view of Gewecke teaches the invention as discussed above in claim 8. Additionally, Holmes teaches wherein the second chamber is larger than the first chamber (see Fig. 5B).
Regarding claim 15, Holmes teaches: A fluid collection loop (blood component collection loop 520 in Fig. 5A and para. [0172]) comprising:
a flexible tube (see flexible loop 524 in Fig. 5A and para. [0172]) having a first end (at filler loop connector 532 in Fig. 5B) and a second end (at system static loop connector 528 in Fig. 5B);
a connector (filler loop connector 421 in Fig. 5B); and
a fluid component collection bladder (blood component collection bladder 536 in Fig. 5A), the connector configured to couple the first end of the flexible loop and the fluid component collection bladder (see para. [0173]), the fluid component collection bladder comprising
a first chamber (first collection flow chamber 544 in Fig. 5B) defined between a top end (at seal 554A in Fig. 5C) and a flow chamber separator (542 in Fig. 5C),
a second chamber (second collection flow chamber 552 in Fig. 5B) defined between a bottom end (at seal 554B in Fig. 5C) and the flow chamber separator, the flow chamber separator extending from a first end of the fluid component collection bladder (at bladder loop end 540A in Fig. 5B) towards a second end of the fluid component collection bladder (at bladder free end 540B in Fig. 5B) and a gap (see flow chamber transition 548 in Fig. 5B) existing between the fluid component collection bladder and the second end of the fluid component collection bladder (see Fig. 5B).
However, Holmes fails to explicitly teach one or more permanent creases that extend between the top end and the bottom end, as required by the claim.
Gewecke teaches an analogous fluid collection container (see col. 1, lines 25-29) comprising a sheet comprising creases for preferential or directionalized folding (see col. 5, line 72 thru col. 6, line 9).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Holmes to incorporate the teachings of Gewecke by including one or more permanent creases that extend between the top end and the bottom end at least in order for preferential or directionalized folding, as taught by Gewecke (see col. 5, line 72 thru col. 6, line 9).
Regarding claim 16, Holmes in view of Gewecke teaches the invention as discussed above in claim 15. Additionally, Holmes teaches wherein the flow chamber separator is a first permanent seal (see para. [0179]), and the fluid component collection bladder further comprises a second permanent seal (at upper bladder seal 554A in Fig. 5C) defining the top end of the fluid component collection bladder (see Fig. 5C), and a third permanent seal defining the second end of the fluid component collection bladder (see Fig. 5B and para. [0173, 0176]).
Regarding claim 17, Holmes in view of Gewecke teaches the invention as discussed above in claim 15. Additionally, Holmes teaches wherein the connector comprises a first flowpath aligned with the first chamber (see para. [0173]), and a second flowpath aligned with the second chamber (see para. [0173]).
Regarding claim 18, Holmes in view of Gewecke teaches the invention as discussed above in claim 17. Additionally, Holmes teaches wherein the connector comprises one or more alignment features (see second connector location feature 530B in Fig. 5B and para. [0177, 0181]).
Regarding claim 19, Holmes in view of Gewecke teaches the invention as discussed above in claim 15. Additionally, Holmes teaches wherein the connector is a first connector (filler loop connector 532 in Fig. 5B), and the fluid collection loop further comprises a second connector joined to a second end of the flexible loop (system static loop connector 528 at the second lower end of the flexible loop 524 in Fig. 5B), the first connector being rotatable and the second connector being fixed so as to transfer torque as applied to the flexible tube to the fluid component collection bladder (Figs. 5A-H show filler loop connector 532 capable of being rotated and system loop connector 528 capable of being fixed so as to transfer torque as applied to flexible loop 524 to fluid component collection bladder).
Regarding claim 20, Holmes in view of Gewecke teaches the invention as discussed above in claim 19. Additionally, Holmes teaches wherein the second connector comprises one or more alignment features (see first connector location feature 530A in Fig. 5B and para. [0177]).
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JIHAD DAKKAK whose telephone number is (571)272-0567. The examiner can normally be reached Mon-Fri: 9AM - 5PM ET.
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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.
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/JIHAD DAKKAK/ Examiner, Art Unit 3781
/ANDREW J MENSH/ Primary Examiner, Art Unit 3781