DETAILED ACTION
This action is in response to applicant's amendments filed 11/17/25.
The examiner acknowledges the amendments to the claims.
Claims 1-9, 11-20 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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/17/25 has been entered.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-9, 11-20 have been considered but are moot in view of the new grounds of rejection set forth in this office action.
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, 11-13, 15-16, 18-19 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/inflow conduit 10 can pass; Figure 40f, para [0266]) extending though the first and second housing (Id.); and,
the through-port sized and shaped for directing a medical device at least partially to an interior of the heart (Id. and para [0268]; inflow conduit 10 can pass into heart 106); and
a balloon 16 (Figures 16a-16b, paras [0189]-[0190]).
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) or sealing element 47 (para [0176]).
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 or 47 (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, [paras [0137]-[0138]; it is noted that the medical device and a cardiac assist unit are only functionally recited, as claim 1 [upon which claim 5 depends] recites “the through-port sized and shaped for directing a medical device at least partially to an interior of the heart”).
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 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 an instrument/inflow conduit 10 can pass; Figure 40f, para [0266]) providing an instrument access to an interior of a heart, the port extending through the first and second housings (Id.);
a balloon 16 (Figures 16a-16b, paras [0189]-[0190]); and
a sealing mechanism 34 or 47 (paras [0154]-[0155]) 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) or sealing element 47 (para [0176]).
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:
first housing 46 separable from a second housing 54 (Figures 40f-40g);
a port (through which a therapeutic instrument/inflow conduit 10 can pass; Figure 40f, para [0266]) 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.);
a balloon 16 (Figures 16a-16b, paras [0189]-[0190]); and
a sealing mechanism 34 or 47 (paras [0154]-[0155]) 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).
Claims 8-9, 14, 17, 20 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 claim 1 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 claims 14, 17, 20, Curtis and Fischvogt teach the claimed invention, as discussed above, except for the sealing mechanism includes a controllable orifice size and 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 controllable orifice size and 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
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DIANE D YABUT/Primary Examiner, Art Unit 3771