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 .
Election/Restrictions
Applicant’s election without traverse of Group 1, Species 5, encompassing Figure 9, Multi-balloon/multiple fill tube embodiment, in the reply filed on 7/14/2026 is acknowledged. It is noticed that Applicant amended claim 1 to include only claim 2, thus current claim 1 directs to species with one expandable bladder. Therefore, claims 1, 3-5, 10, 21, 24, 25, 27-29 are withdrawn from consideration. Claim 6, 7, 22, 23, 26, 30-33 direct to Group 1, Species 5, encompassing Figure 9, Multi-balloon/multiple fill tube embodiment.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/04/2024 is being considered by the examiner.
Claim Objections
Claims 6, 7, 22-23, 26 30-31 are objected to because of the following informalities: Claims 6, 7, 22-23, 26, and 30-31 depend on non-elected claims 1, 25 and 27. Appropriate correction is required. Applicants are required to rewrite the elected dependent claim in independent form or otherwise amend it so that it depends only from an elected claim.
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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(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.
Claim(s) 6, 7, 22-23, 26, 30-33 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Spence (WO 2017/151566 A1).
Claims 6, 30, 32, and 33: Spence discloses a device for treating a heart valve comprising: a curved frame (88), a first expandable bladder (94) and a second expandable bladder (96) connected to the curved frame (88, with the broadest reasonable interpretation all members of the heart valve being connected), as shown in Figure 8C; and a covering (84) at least partially enclosing the curved frame (88) and the first and second expandable bladders (Fig. 8C),
Claims 7 and 31: Spence discloses first and second fill tubes (38, fig. 8C),
Claim 22: Spence discloses the first expandable bladder and the second expandable bladder being disposed in series along the curved frame (Fig. 8C);
Claim 23: Spence discloses a heart valve includes a first expandable bladder (100), a second expandable bladder (102), a third expandable bladder (104), wherein the first expandable bladder (100) is disposed between, and in series with, the second expandable bladder (102) and the third expandable bladder (104) along the curved frame (84),
Claim 26: Spence discloses in another embodiment (fig. 31A-31C) wherein the first expandable bladder (364) forms a loop and extends along a full length of the curved frame and a second expandable bladder coupled to the first expandable bladder, curved frame (484), a covering (482)
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 6, 7, 22, 23, 26, 30, 31, 32, and 33 are rejected under 35 U.S.C. § 103 as being unpatentable over Braido (US 2015/0216658 A1) in view of Spence (WO 2017/151566 A1).
Braido discloses a device for treating a heart valve comprising: a curved frame, as shown in Figure 9; a first expandable bladder 112 connected to the curved frame, as shown in Figure 10; and a covering 110 at least partially enclosing the curved frame and the first expandable bladder, as shown in Figures 10–11. However, Braido does not disclose:
a second expandable bladder, as recited in claims 6 and 32;
first and second fill tubes, as recited in claim 7;
the first expandable bladder and the second expandable bladder being disposed in series along the curved frame, as recited in claims 22 and 33; or
a third expandable bladder, wherein the first expandable bladder is disposed between, and in series with, the second expandable bladder and the third expandable bladder along the curved frame, as recited in claim 23.
Spence discloses a device for treating a heart valve comprising a frame, a first expandable bladder, a second expandable bladder, and a third expandable bladder disposed along the frame, as well as at least first and second fill tubes, as shown in Figures 22A–25C.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Braido to include additional expandable bladders and fill tubes, as taught by Spence, in order to further improve sealing of the device against the heart valve anatomy.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Mitra et al. US 9216076 B2 discloses a heart valve with plurality of balloon (80, Fig. 6E).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAN-UYEN THI HO whose telephone number is (571)272-4696. The examiner can normally be reached Normal Schedule M-F Between 7:00 am and 4:00 pm.
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, TAN-UYEN T HO can be reached at 7034745263. 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.
/TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771
Prosecution Insights