DETAILED ACTION
This action is in response to applicant's amendments filed 04/28/26.
The examiner acknowledges the amendments to the claims.
Claims 1-9, 11-22 are pending in this application.
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 arguments filed 04/28/26 have been fully considered but they are not persuasive.
Applicant generally argues that the prior art of record including Curtis does not disclose at least one directional flow element in said through-port/port in addition to a balloon having multiple lobes. However, as discussed below, Curtis teaches a hemostatic valve assembly including multiple fluid-tight seals ([0258]), including at least one directional flow element 47 in said through-port or port ([0176]; housing seal 47 allows passage of an instrument, and prevents the directional flow of blood from the heart past the seal). Therefore, the claim rejections stand.
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 1-7, 11-16, 18-22 are rejected under 35 U.S.C. 103 as being unpatentable over Curtis et al., hereinafter “Curtis” (U.S. Pub. No. 2012/0296151) in view of Fischvogt (U.S. Pub. No. 2012/0157779).
Regarding claim 1, Curtis discloses a hemostatic valve assembly (Figures 1-2b; paras [0141], [0156]) for placement on a heart comprising:
a first housing 46 (Figures 40f-40g);
a second housing 54;
the first and second housing being splittable relative each other (Figures 40f-40g; paras [0268]-[0269]);
a through-port (through which a medical device [coring knife 140 or inflow conduit 10] can pass, within housing 18 of valvular structure 12/housings 46, 54, and within attachment ring 22; Figures 40c-f, paras [0261]-[0266]) having a diameter and extending though the first and second housing (Id.); and,
a medical device (coring knife 140) having a distal diameter smaller than the diameter of the through-port (see Figures 38, 39a, 40c, [0261]; knife head 136 of coring knife 140 has a smaller diameter that fits within the diameter of through-port within housing 18 of valvular structure 12/housings 46, 54, and within attachment ring 22) and said medical device having a proximal diameter larger than the diameter of the through-port (see Figures 40c-40d; knife handle 139 of coring knife 140 has a diameter larger than that of the through-port), wherein the medical device can also include pump 8/inflow conduit 10, wherein the medical device has a distal diameter of inflow conduit 10 that is smaller than the diameter of the through-port and a proximal diameter of the pump 8 that is larger than the diameter of the through-port (Figures 1, 40f, 40h, [paras [0137]-[0138], [0266]);
the through-port sized and shaped for directing the medical device at least partially to an interior of the heart (Id. and Figure 40c; [0261]); and
a balloon 16 (Figures 16a-16b, paras [0189]-[0190]), and at least one directional flow element 47 in said through-port ([0176]; housing seal 47 allows passage of an instrument, and prevents the directional flow of blood from the heart past the seal).
However, Curtis does not disclose that the balloon comprises multiple lobes, wherein the lobes are arranged adjacent to each other in a single layer.
In the same field of art, namely valve assemblies, Fischvogt teaches in Figures 1, 7, 9-10 a balloon (inflatable) valve 220 or 320 (Figures 9-10; [0038]) that comprises multiple lobes arranged adjacent to each other in a single layer.
It would have been obvious to one of ordinary skill before the effective filing date to modify the balloon of Curtis to have multiple lobes as claimed, as taught by Fischvogt, since doing so would be substitution of one known balloon for another, which would yield predictable results, namely selectively opening and closing the valve in the hemostatic valve assembly in order to receive an instrument. See MPEP 2143.
Regarding claims 2 and 6, Curtis discloses a connection interface (including attachment ring 22, clamp 24; para [0154]) disposed on the valve assembly and configured to mate with a heart access device (Id.; clamp 24 can hold and seal attachment ring 22 against inflow conduit 10), and further comprising a sealing element 34 (paras [0154]-[0155]) matable with the access device (via sealing against an inflow conduit 10 when it is passed through).
Regarding claim 3, Curtis discloses the through-port includes a controllable orifice size (balloon valve 16 seals against inflow conduit 10, wherein the valve has an adjustable orifice size as seen in Figures 16a-16b, paras [0189]-[0190] where valve membrane 73 is inflatable/deflatable to close and open orifice 58, respectively).
Regarding claim 4, Curtis discloses a seal 34 (paras [0154]-[0155]) for engaging the medical device (via sealing against an inflow conduit 10 when it is passed through).
Regarding claim 5, Curtis discloses the medical device is a cardiac assist unit (including pump 8/inflow conduit 10, wherein the medical device has a distal diameter of inflow conduit 10 that is smaller than the diameter of the through-port and a proximal diameter of the pump 8 that is larger than the diameter of the through-port; Figures 1, 40f, 40h, [paras [0137]-[0138], [0266]).
Regarding claim 7, Curtis discloses the first housing 46 and the second housing 54 are adjoinable to one another (Figures 40f-40g, para [0179]; the splittable first and second housings can be closed and latch 69 can be closed).
Regarding claim 11, Curtis discloses being splittable is constituted by the first housing and the second housing being peeled off from each other (Figures 40f-40g; para [0268], the first and second housings 46, 54 can be grasped and pulled apart).
Regarding claim 12, Curtis discloses a hemostatic valve (Figures 16a-16b, 40f-40g) for mounting on a heart comprising:
first housing 46 and a second housing 54 (Figures 40f-40g);
the first housing and second housing being separable from each other (paras [0268]-[0269]);
a port (through which a medical device [coring knife 140 or inflow conduit 10] can pass, within housing 18 of valvular structure 12/housings 46, 54, and within attachment ring 22; Figures 40c-f, paras [0261]-[0266]) having a diameter providing an instrument access to an interior of a heart, the port extending through the first and second housings (Id.), the port comprising at least one directional flow element 47 ([0176]; housing seal 47 allows passage of an instrument, and prevents the directional flow of blood from the heart past the seal);
a medical device (coring knife 140) having a distal diameter smaller than the diameter of the port (see Figures 38, 39a, 40c, [0261]; knife head 136 of coring knife 140 has a smaller diameter that fits within the diameter of through-port within housing 18 of valvular structure 12/housings 46, 54, and within attachment ring 22) and said medical device having a proximal diameter larger than the diameter of the port (see Figures 40c-40d; knife handle 139 of coring knife 140 has a diameter larger than that of the through-port), wherein the medical device can also include pump 8/inflow conduit 10, wherein the medical device has a distal diameter of inflow conduit 10 that is smaller than the diameter of the through-port and a proximal diameter of the pump 8 that is larger than the diameter of the through-port (Figures 1, 40f, 40h, [paras [0137]-[0138], [0266]);
a balloon 16 (Figures 16a-16b, paras [0189]-[0190]); and
a sealing mechanism 60 ([0175], [0258], Figures 39a-b) located in the port.
However, Curtis does not disclose the balloon comprising multiple lobes, wherein the lobes are arranged adjacent to each other in a single layer.
In the same field of art, namely valve assemblies, Fischvogt teaches in Figures 1, 7, 9-10 a balloon (inflatable) valve 220 or 320 (Figures 9-10; [0038]) that comprises multiple lobes arranged adjacent to each other in a single layer.
It would have been obvious to one of ordinary skill before the effective filing date to modify the balloon of Curtis to have multiple lobes as claimed, as taught by Fischvogt, since doing so would be substitution of one known balloon for another, which would yield predictable results, namely selectively opening and closing the valve. in the hemostatic valve assembly in order to receive an instrument. See MPEP 2143.
Regarding claims 13 and 16, Curtis discloses a connection interface (including attachment ring 22, clamp 24; para [0154]) disposed on the hemostatic valve and configured to mate with a heart access device (Id.; clamp 24 can hold and seal attachment ring 22 against inflow conduit 10), and further comprising a sealing element 34 (paras [0154]-[0155]) matable with the access device (via sealing against an inflow conduit 10 when it is passed through).
Regarding claim 14, Curtis discloses the sealing mechanism 60 includes a controllable orifice size ([0175]; since the seal 60 is resilient, the seal can be deformed or stretched when a coring knife or inflow conduit is introduced and extended through the seal).
Regarding claim 15, Curtis discloses the instrument is a cardiac assist unit (including pump 8/inflow conduit, [paras [0137]-[0138]; it is noted that the instrument is only functionally recited, as claim 12 [upon which claim 15 depends] recites “a port providing an instrument access to an interior of a heart”).
Regarding claim 18, Curtis discloses a hemostatic valve for attachment to a heart comprising:
a first housing 46 separable from a second housing 54 (Figures 40f-40g);
a port (through which a medical device [coring knife 140 or inflow conduit 10] can pass, within housing 18 of valvular structure 12/housings 46, 54, and within attachment ring 22; Figures 40c-f, paras [0261]-[0266]) having a diameter and sized for allowing a therapeutic instrument access to an interior of a heart (Id. and para [0268]; inflow conduit 10 can pass into heart 106), the port extending through the first and second housings (Id.), the port comprising at least one directional flow control element 47 ([0176]; housing seal 47 allows passage of an instrument, and prevents the directional flow of blood from the heart past the seal);
a medical device (coring knife 140) having a distal diameter smaller than the diameter of the port (see Figures 38, 39a, 40c, [0261]; knife head 136 of coring knife 140 has a smaller diameter that fits within the diameter of through-port within housing 18 of valvular structure 12/housings 46, 54, and within attachment ring 22) and said medical device having a proximal diameter larger than the diameter of the port (see Figures 40c-40d; knife handle 139 of coring knife 140 has a diameter larger than that of the through-port), wherein the medical device can also include pump 8/inflow conduit 10, wherein the medical device has a distal diameter of inflow conduit 10 that is smaller than the diameter of the through-port and a proximal diameter of the pump 8 that is larger than the diameter of the through-port (Figures 1, 40f, 40h, [paras [0137]-[0138], [0266]);
a balloon 16 (Figures 16a-16b, paras [0189]-[0190]); and
a sealing mechanism 60 ([0175], [0258], Figures 39a-b) located in the port.
However, Curtis does not disclose the balloon comprising multiple lobes, wherein the lobes are arranged adjacent to each other in a single layer.
In the same field of art, namely valve assemblies, Fischvogt teaches in Figures 1, 7, 9-10 a balloon (inflatable) valve 220 or 320 (Figures 9-10; [0038]) that comprises multiple lobes arranged adjacent to each other in a single layer.
It would have been obvious to one of ordinary skill before the effective filing date to modify the balloon of Curtis to have multiple lobes as claimed, as taught by Fischvogt, since doing so would be substitution of one known balloon for another, which would yield predictable results, namely selectively opening and closing the valve. Regarding claim 19, Curtis discloses a connection interface (including attachment ring 22, clamp 24; para [0154]) disposed on the hemostatic valve and configured to mate with a heart access device (Id.; clamp 24 can hold and seal attachment ring 22 against inflow conduit 10).
Regarding claim 20, Curtis discloses the sealing mechanism 60 includes a controllable orifice size ([0175]; since the seal 60 is resilient, the seal can be deformed or stretched when a coring knife or inflow conduit is introduced and extended through the seal), and optionally, the at least one directional flow control element comprises at least one flap.
Regarding claims 21-22, Curtis and Fischvogt teach the claimed invention, as discussed above, except for the at least one directional flow control element (housing seal 47 in Curtis) comprises at least one flap.
Curtis further teaches another seal or directional flow control element 82 (Figures 21a-c; [0206]-[0209]) comprising at least one flap 87 (Id.).
It would have been obvious to one of ordinary skill before the effective filing date to modify the at least one directional control element with at least one flap, as taught by Curtis, since doing so would be substitution of one known directional flow control element for another, which would yield predictable results, namely sealing against instruments and medical devices when introduced therethrough and preventing leakages. See MPEP 2143.
Claims 8-9, 17 are rejected under 35 U.S.C. 103 as being unpatentable over Curtis (U.S. Pub. No. 2012/0296151) in view of Fischvogt (U.S. Pub. No. 2012/0157779), as applied to claims 1 and 12 above, and further in view of Burns (U.S. Patent No. 5,085,636).
Regarding claims 8-9, Curtis and Fischvogt teach the claimed invention, as discussed above, except for the hemostatic valve assembly further comprising a pneumatic valve, and further a reservoir unit in fluid communication with the pneumatic valve.
In Figure 4A, col. 5, lines 3-23, Burns teaches a pneumatic valve (inflatable balloon valve 90) in fluid communication with a reservoir unit via tube 92 (Id.; although a reservoir unit is not explicitly taught, Burn teaches a low viscosity fluid is supplied to the inflatable balloon valve, and therefore a fluid source or reservoir unit is in fluid communication with the tube 92 which is in fluid communication with the valve 90 for inflation).
It would have been obvious to one of ordinary skill before the effective filing date to modify Curtis and Fischvogt with a pneumatic valve and reservoir unit as claimed, as taught by Burns, in order to allow a user to selectively seal against a medical device and prevent leaks, and to facilitate supplying fluid to the valve in order to selectively close and seal against the medical device.
Regarding claim 17, Curtis and Fischvogt teach the claimed invention, as discussed above, except for the sealing mechanism includes a pneumatic valve.
In Figure 4A, col. 5, lines 3-23, Burns teaches a sealing mechanism including a controllable orifice size via a pneumatic valve (inflatable balloon valve 90 may be expanded to minimize the orifice size to seal against instrument such as 82) in fluid communication with a reservoir unit via tube 92.
It would have been obvious to one of ordinary skill before the effective filing date to modify Curtis and Fischvogt with a pneumatic valve as claimed, as taught by Burns, in order to allow a user to selectively seal against a medical device and prevent leaks.
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 DIANE D YABUT whose telephone number is (571)272-6831. The examiner can normally be reached M-F 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at 571-272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DIANE D YABUT/Primary Examiner, Art Unit 3771
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