DETAILED ACTION
This action is in response to applicant's amendments filed 03/09/26.
The examiner acknowledges the amendments to the claims.
Claims 1-20 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/09/2026 has been entered.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Objections
Claim 7 is objected to because of the following informalities: line 6 recites “though-port’s” and should rather read as --through-port’s--. Appropriate correction is required.
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.
(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, 6-8, 10-12, 14, 16-17, 19-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yu et al., hereinafter “Yu” (U.S. Pub. No. 2004/0002624).
Regarding claim 1, Yu discloses an access device for a heart chamber comprising:
an apical base plate 12 (Figures 1, 3 5; [0023]);
a sealing unit 42 ([0027]-[0028]) associated with the base plate (connected via 14), the sealing unit comprising a sealing surface (inner portion of seal 42);
an open channel 14 having an inner wall 16 and extending through the apical base plate (Figures 1, 4; [0025]) when the sealing unit 42 is positioned in the base plate against the inner wall ([0027]-[0028]); and,
the channel sized and shaped to removably receive at least a portion of a cardiac assist unit (such as ventricular assist device 44, [0028]; it is noted that "sized and shaped to removably receive at least a portion of a cardiac assist unit" constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner and the Office submits that the open channel meets the structural limitations of the claim, and is capable of providing a passageway for receiving and removing at least a portion of a cardiac assist unit),
wherein the channel is open (see open-shaped ring 14 and O-ring 42; Figure 3) before the cardiac assist unit is attached to the access device (Figure 5).
Regarding claim 3, Yu discloses the sealing unit includes a feed-through port (see passage through O-ring 42) aligned with the channel 14.
Regarding claim 4, Yu discloses the sealing unit has a seal mechanism in the feed-through port ([0027]; inner portion of seal 42 may provide a generally leak-proof seal against an inflow tube 46 of ventricular assist device 44 to control blood flow).
Regarding claim 6, Yu discloses the cardiac assist unit includes a drive unit attachable to the base plate (it is noted that the cardiac assist unit is only functionally recited, as mentioned above, and not positively recited and the apical base plate meets the structural limitations of the claim and is capable of being attached to a drive unit [or pump portion; [0013]] via the cardiac assist device).
Regarding claim 7, Yu discloses an implantable cardiac assist system comprising:
an access device 10 (Figures 1 and 3, [0023]) for attachment to an external surface of a heart (Id.);
the access device having an open through-port 14 providing access to an interior of a heart when attached to the external surface of a heart (Figure 2; [0024]),
wherein the through-port comprises an inner portion 16 and a seal 42 ([0027]-[0028]), the seal comprising a sealing surface (inner portion of seal 42), positioned at the through-port's inner portion providing a sealing against a sealing member (the inner portion of seal 42 provides a sealing [to inflow tube 46] against the member/body of seal 42), wherein the through-port is open (see passage through O-ring 42) before the cardiac assist unit is attached to the access device (Figure 5),
a cardiac assist unit (ventricular assist device 44, [0028]) sized for placement in the through-port (Id.) such that at least a portion of the cardiac assist unit extends to the interior of a heart (Id.); and,
the cardiac assist unit sized for creating a seal in the through-port 14 (Id.).
Regarding claim 8, Yu discloses said cardiac assist unit comprises a drive unit (pump portion; [0013]).
Regarding claim 10, Yu discloses the cardiac assist unit 44 includes a connection interface (including inflow tube 46; [0028]) to engage with the access device.
Regarding claims 11-12, Yu discloses the access device includes an implantable apical base plate 12 (Figures 1, 3 5; [0023]), wherein the implantable apical base plate comprises a flange (Id.).
Regarding claim 14, Yu discloses a device for accessing a heart chamber comprising:
a base plate 12 (Figures 1, 3 5; [0023]) attachable to an apex of a heart (Id.);
a sealing unit 42 ([0027]-[0028]) associated with the base plate (connected via 14) comprising a sealing surface (inner portion of seal 42);
an open channel 14 having an inner wall 16 and extending through the base plate (Figures 1, 4; [0025]) when the sealing unit 42 is positioned in the base plate against the inner wall ([0027]-[0028]); and,
the channel sized and shaped to removably receive at least a portion of a cardiac assist unit (such as ventricular assist device 44, [0028]; it is noted that "sized and shaped to removably receive at least a portion of a cardiac assist unit" constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner and the Office submits that the channel meets the structural limitations of the claim, and is capable of providing a passageway for receiving and removing at least a portion of a cardiac assist unit), wherein the channel is open (see open-shaped ring 14 and O-ring 42; Figure 3) before attachment of the cardiac assist unit to the access device (Figure 5).
Regarding claim 16, Yu discloses the sealing unit 42 includes a feed-through port (see path through O-ring 42) aligned with the channel 14.
Regarding claim 17, Yu discloses the sealing unit has a seal mechanism ([0027]; inner portion of seal 42 may provide a generally leak-proof seal against an inflow tube 46 of ventricular assist device 44 to control blood flow) in the feed-through port.
Regarding claim 19, Yu discloses the cardiac assist unit includes a drive unit attachable to the base plate (it is noted that the cardiac assist unit is only functionally recited, as mentioned above, and not positively recited and the base plate meets the structural limitations of the claim and is capable of being attached to a drive unit via the cardiac assist device).
Regarding claim 20, Yu discloses the base plate is an apical base plate 12 (Figures 1, 3 5; [0023]).
Claims 7-8 and 10-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bourque (U.S. Pub. No. 2011/0160850).
Regarding claim 7, Bourque discloses an implantable cardiac assist system comprising:
an access device (including removable inlet cannula 510; Figure 7) for attachment to an external surface of a heart ([0041]);
the access device having an open through-port 518 providing access to an interior of a heart when attached to the external surface of a heart ([0042]),
wherein the through-port comprises an inner portion (inner wall of 510) and a seal 519 ([0043]), the seal comprising a sealing surface (inner portion of seal 519), positioned at the through-port's inner portion providing a sealing against a sealing member, [0043]; the inner portion of seal 519 provides a sealing [to inlet port 130] against the member/body of seal 519), wherein the through-port is open (see open ring-shaped seal 519; Figure 7) before the cardiac assist unit is attached to the access device ([0043]),
a cardiac assist unit 110 ([0042]-[0043]) sized for placement in the through-port such that at least a portion of the cardiac assist unit extends to the interior of a heart (as in Figure 6); and,
the cardiac assist unit sized for creating a seal in the through-port ([0043]).
Regarding claim 8, Bourque discloses said cardiac assist unit 110 comprises a drive unit (see abstract, [0004], [0025]).
Regarding claim 10, Bourque discloses the cardiac assist unit 110 includes a connection interface (including inlet port 130) to engage with the access device ([0043]).
Regarding claims 11-12, Bourque discloses the access device includes an implantable apical base plate 514 (Figure 7; [0041]), wherein the implantable apical base plate comprises a flange (Id.).
Regarding claim 13, Bourque discloses the through port 518 comprises a tube extending into the heart (Figure 7; [0041]).
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 2 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Yu (U.S. Pub. No. 2004/0002624) in view of Nguyen et al., hereinafter “Nguyen” (U.S. Pub. No. 2018/0050143).
Regarding claims 2 and 15, Yu discloses the claimed invention, as discussed above, including the sealing unit 42 is positioned in the base plate 14 ([0025]), except for the sealing unit extends into the heart chamber.
In the same field of art, namely an access device for a heart chamber, Nguyen teaches in Figures 8-12 and [0078]-[0079] a sealing unit 68 that extends into a heart chamber, wherein the sealing unit acts as an O-ring seal over an inflow cannula 28 of a cardiac assist unit 22 (Figure 2) in order to help reduce bleeding and leaks after installation.
It would have been obvious to one of ordinary skill before the effective filing date to modify the sealing unit in Yu such that the sealing unit extends into the heart chamber, as taught by Nguyen, in order to further reduce leaks and doing so would be substitution of one known sealing unit for another, which would yield predictable results, namely preventing blood from leaking after installing a cardiac assist unit. See MPEP 2143.
Claims 5 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Yu (U.S. Pub. No. 2004/0002624) in view of Wenchell (U.S. Pub. No. 2006/0217666).
Regarding claims 5 and 18, Yu discloses the claimed invention, as discussed above, except for said sealing unit includes a magnetic coupling.
In the same field of art, namely access devices, Wenchell teaches an access device including a base 210 and a sealing unit 102 (Figure 2, [0033]) including a magnetic coupling (see abstract, [0025], [0034]) which helps to retain the sealing unit within the base.
It would have been obvious to one of ordinary skill before the effective filing date to modify Yu with a magnetic coupling as claimed, as taught by Wenchell, in order to facilitate retention between the sealing unit and the apical base plate (Id.).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Yu (U.S. Pub. No. 2004/0002624) in view of Salys (U.S. Pub. No. 2018/0243492).
Regarding claim 9, Yu discloses the claimed invention, as discussed above, except for the through-port including a sealing element (Yu teaches a sealing unit including O-ring 42; [0027]).
In the same field of art, namely implantable cardiac assist systems, Salys teaches in [0054] that a through-port 12 can have one or more seal members (O-ring seals) to enhance a fluid-tight seal against a cardiac assist unit (inlet cannula 42 of VAD 38).
It would have been obvious to one of ordinary skill before the effective filing date to modify Yu with a sealing element, as taught by Salys, in order to strengthen the fluid-tight seal with a cardiac assist unit and prevent blood from leaking.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Bourque (U.S. Pub. No. 2011/0160850) in view of Salys (U.S. Pub. No. 2018/0243492).
Regarding claim 9, Bourque discloses the claimed invention, as discussed above, except for the through-port including a sealing element (Bourque teaches a sealing unit including sealing ring 519; [0043]).
In the same field of art, namely implantable cardiac assist systems, Salys teaches in [0054] that a through-port 12 can have one or more seal members (O-ring seals) to enhance a fluid-tight seal against a cardiac assist unit (inlet cannula 42 of VAD 38).
It would have been obvious to one of ordinary skill before the effective filing date to modify Bourque with a sealing element, as taught by Salys, in order to strengthen the fluid-tight seal with a cardiac assist unit and prevent blood from leaking.
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
Prosecution Insights