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 Amendment
Claims 1, 3-4, and 18-24 are currently pending.
Response to Arguments
Applicant’s arguments, see pages 4-6 of Applicant’s Remarks, filed 05/14/26, with respect to the rejections of claims 1, 3-4, 18-20, and 24 under 35 U.S.C. 103 as being unpatentable over Chambers in view of Prasad and in further view of Peticca have been fully considered and are not persuasive.
Applicant argues, see pages 5-6, that the rotary vane member of Peticca is intended to rotate to provide a pumping action to pressurize the blood to cause the blood to flow from the inlet to the outlet, and that one of ordinary skill in the art would not look to a rotating vane member to modify the fixed, conical separator/flow diverter of Chambers (Fig. 3, feat. 18). Applicant further argues that Peticca teaches away from modifying the fixed flow diverter of Chamber by disclosing a rotating vane member rather than a fixed flow diverter.
However, both the fixed separator/flow diverter of Chambers (Fig. 3, feat. 18; Col. 5, lines 21-32) and the rotary vane member of Peticca (Figs. 2 and 4; ¶0041 and 0055-0060) have conical or frustroconical profiles that direct blood radially. The rotary vane member of Peticca further includes spiraling vanes (Fig. 4, feat. 232a-d), and therefore a spiral shape, which further help ensure a uniform radial flow distribution (¶0041 and 0055-0060). Because they have similar shapes and functions, and the vane member of Peticca has additional features which help ensure a uniform radial flow distribution, one of ordinary skill in the art would look to the rotating vane member of Peticca for ways to improve the functioning of the fixed flow diverter of Chambers.
Additionally, even if Peticca teaches a rotating vane member, Peticca does not teach away from modifying a fixed flow diverter, like the one of Chambers, because Peticca does not criticize, discredit, or otherwise discourage investigation into fixed flow diverters. Please see MPEP §2145(X)(D).
Applicant’s argument, see page 6, with respect to the rejections of claims 21-23 under 35 U.S.C. 103 as being unpatentable over Chambers in view of Peticca and in further view of Tuval have been fully considered and are not persuasive in light of the rejection of independent claim 1 being maintained.
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.
Claims 1, 3-4, 18-20, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Chambers et al. (US 6,682,698 B2) in view of Prasad et al. (US 5,352,361 A) and in further view of Peticca et al. (US 2017/0007755 A1).
Regarding claims 1, 20, and 24, Chambers discloses a blood oxygenator (Figs. 1-4, feat. 10; Col. 3, line 51 – Col. 4, line 53) comprising: a housing (12) having a first end opposite a second end with a sidewall extending between the first end and the second end along a longitudinal axis (26 and 28 are the inner and outer surface of the sidewall), the housing defining an interior chamber (34) having a fluid inlet (14; Col. 5, lines 21-32) and a fluid outlet (20; Col. 6, lines 15-45); a gas exchange medium (16) positioned within the interior chamber (34), the gas exchange medium having a plurality of hollow fibers (Col. 4, line 46 – Col. 5, line 20), the gas exchange medium defining an inner cavity extending longitudinally through its center (Figs. 2-3: gas exchange medium 16 has a hollow inner cavity); and a flow diverter (Fig. 3, feat. 18) positioned within the inner cavity of the gas exchange medium (Figs. 2-3: flow diverter 18 is in the center of the inner cavity of the gas exchange medium 16) and configured for guiding fluid flow through the gas exchange medium (Col. 5, line 21 – Col. 6, line 14), wherein the flow diverter has a fixed end fixedly connected to a central portion of the housing (Col. 5, lines 33-50: separator 18 is attached to the second end 32 of the housing 12) and a free end extending from the first end along the longitudinal axis (Col. 5, lines 51-65), and a length extending therebetween (Fig. 3, feat. 18; Col. 5, lines 33-50).
Chambers does not disclose that the hollow fibers are in a single continuous woven fiber mat rolled into a spiral shape around the longitudinal axis, that the flow diverter has a spiral shape between the fixed end and the free end, or that the spiral shaped flow diverter has a diameter that is 90% to 95% of a diameter of the inner cavity of the gas exchange medium along a majority of the length of the flow diverter.
Prasad teaches hollow fiber filter membrane bundles comprising a spirally wound hollow fiber bundle (Col. 2, line 46 – Col. 3, line 68) comprising a plurality of hollow fibers fabricated into a fabric-like array in which the hollow fibers constitute weft filaments held in place by warp filaments, which may be either solid or additional hollow fibers (Col. 6, line 45 – Col. 7, line 10). Because the fabric-like array of hollow fibers comprises warp and weft filaments, the fabric-like array is a continuous woven fiber mat. The fiber bundle is then formed by winding the fabric-like array around a core mandrel in a spiral pattern (Col. 7, line 11 – Col. 8, line 8). Prasad teaches that forming the fibers into a woven fabric-like array advantageously promotes regularity of the fiber bundle and therefore uniform fluid flow dynamics (Col. 6, lines 45-52). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the oxygenator disclosed by Chambers so that the hollow fibers are in a single continuous woven fiber mat rolled into a spiral shape around the longitudinal axis in order to promote regularity of the fiber bundle and therefore uniform fluid flow dynamics of the blood in the oxygenator as taught by Prasad.
Chambers in view of Prasad does not disclose that the flow diverter has a spiral shape between the fixed end and the free end or that the spiral shaped flow diverter has a diameter that is 90% to 95% of a diameter of the inner cavity of the gas exchange medium along a majority of the length of the flow diverter
Peticca teaches a blood oxygenator (Fig. 2, feat. 200; ¶0028) comprising a pump module (230; ¶0041) for pumping blood from the inlet (242) to the outlet (244) through the oxygenator module (240), which includes a heat exchanger (248; ¶0033) and oxygenator fiber bundle (250). Peticca also discloses that the outer profile of the pump module (Figs. 2 and 4, feat. 230), which includes the rotary vane member (232) may be cylindrical (¶0053), and would therefore have a substantially uniform diameter along its length. Peticca teaches that the pump module (230) comprises a tapering rotary vane member (Figs. 2 and 4, feat. 232; ¶0041) in the center of the heat exchanger (248) and oxygenator (250) fiber bundles and which includes vanes (that necessarily create grooves) which may be attached in curved spirals to the rotary vane member (232a-d; ¶0055-0060). Peticca teaches that the rotary vane member and vanes help to ensure a uniform radial flow distribution in the oxygenator (¶0041). The rotary vane member of Peticca redirects or diverts flow from the axial direction from the inlet (Fig. 2, feat. 242) to the radial direction to the outlet (Fig. 2, feat. 244), and therefore the rotary vane member of Peticca is a flow diverter. Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the oxygenator suggested by Chambers in view of Prasad so that the flow diverter has a spiral shape between the fixed end and the free end, with respect to claim 1, so that the spiral shaped flow diverter has at least one spiral groove extending the length of the flow diverter, the at least one groove creating at least one spiral ridge extending the length of the flow diverter, with respect to claim 20, and so that a diameter of the flow diverter is uniform along its length, with respect to claim 24, in order to help ensure a uniform radial flow distribution in the oxygenator as taught by Peticca.
Chambers in view of Prasad and in further view of Peticca does not disclose the diameter of the flow diverter along the majority of the length of the flow diverter as claimed. However, the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. Please see MPEP §2144.04(IV)(A) with respect to the discussion of Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984). In the current case, modifying the flow diverter of Chambers to include spiral shaped vanes would provide a uniform radial flow distribution of the blood through the gas exchange medium, as taught by Peticca (Peticca: ¶0041), in the same manner as the flow diverter of the claimed invention (Please see ¶0051 of the present specification. Therefore, the flow diverter of the oxygenator suggested by Chambers in view of Prasad and in further view of Peticca having the claimed relative dimensions would not perform differently than the claimed oxygenator, and therefore the spiral shaped flow diverter having a diameter that is 90% to 95% of a diameter of the inner cavity of the gas exchange medium along a majority of the length of the flow diverter does not render the claimed device patently distinct from the prior art of record.
Regarding claim 3, Chambers in view of Prasad and in further view of Peticca suggests the blood oxygenator of claim 1, and Chambers further discloses that a diameter of the flow diverter increases or decreases between the fixed end and the free end (Fig. 3, feat. 18; Col. 5, line 51 – Col. 6, line 6).
Regarding claim 4, Chambers in view of Prasad and in further view of Peticca suggests the blood oxygenator of claim 1, and Chambers further discloses that the flow diverter (Fig. 3, feat. 18) extends along 25% to 100% of the longitudinal length of the gas exchange medium (16; Col. 5, lines 33-50).
Regarding claim 18, Chambers in view of Prasad and in further view of Peticca suggests the blood oxygenator of claim 1, and Chambers further discloses that the flow diverter (Fig. 3, feat. 18) extends along 50% or more of the length of the gas exchange medium (16; Col. 5, lines 33-50).
Regarding claim 19, Chambers in view of Prasad and in further view of Peticca suggests the blood oxygenator of claim 1, and Chambers further discloses that the flow diverter (Fig. 3, feat. 18) extends along 75% or more of the length of the gas exchange medium (16; Col. 5, lines 33-50).
Claims 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over Chambers et al. (US 6,682,698 B2) in view of Prasad et al. (US 5,352,361 A), in further view of Peticca et al. (US 2017/0007755 A1), and in further view of Tuval et al. (WO 2018/078615 A1).
Regarding claims 21-23, Chambers in view of Prasad and in further view of Peticca suggests the blood oxygenator of claim 1, but does not disclose that the flow diverter has 0.5 to 10 twists per inch along its length, with respect to claim 21, that the flow diverter has 0.5 to 5 twists per inch along its length, with respect to claim 22, or that the flow diverter has 2 to 8 twists per inch along its length, with respect to claim 23.
Tuval teaches an impeller (Fig. 2, feat. 42; Figs. 4A-5D, feat. 50; Page 8, line 21 – Page. 9, line 9), or flow diverter, for a blood pump (Figs. 2 and 4, feat. 40; Page 7, line 16 – Page 8, line 3) comprising a helical, or spiral shaped, element (52, 56). Tuval teaches that the pitch of the helical element controls the blood flow created by the impeller, and that the pitch should be between 1 mm (about 25.4 twists per inch) and 20 mm (about 1.27 twists per inch) to produce sufficient flow (Page 12, lines 16-28). The prior art range of 1.27 to 25.4 twists per inch overlaps the range of 0.5 to 10 twists per inch of claim 21, the range of 0.5 to 5 twists per inch of claim 22, and the range of 2 to 8 twists per inch of claim 23, and therefore a prima facie case exists for the claimed ranges. Please see MPEP §2144.05(I). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the oxygenator suggested by Chambers in view of Prasad and in further view of Peticca so that the flow diverter has 0.5 to 10 twists per inch along its length, with respect to claim 21, so that the flow diverter has 0.5 to 5 twists per inch along its length, with respect to claim 22, or so that the flow diverter has 2 to 8 twists per inch along its length, with respect to claim 23, in order to produce sufficient flow as taught by Tuval.
Conclusion
THIS ACTION IS MADE FINAL. 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 ARJUNA P CHATRATHI whose telephone number is (571)272-8063. The examiner can normally be reached M-F 8:30-5:00.
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/ARJUNA P CHATRATHI/Examiner, Art Unit 3781
/CATHARINE L ANDERSON/Primary Examiner, Art Unit 3781
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