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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 19 March 2026 has been entered.
Claim Rejections - 35 USC § 102
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) 17-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Pre-Grant Publication 2008/0243081 to Nance et al. (Nance hereinafter).
Regarding claim 17, Nance teaches another trans-septal sheath generally, and particularly teaches that an inflatable sheath (1300) is advanced to a target point (502), forms a puncture (paragraph 85), advances through the puncture and expands an inflatable anchor (see Figs. 6 and 7).
Regarding claim 18, Nance teaches using a radiopaque marker (e.g. 508) and visualizing and confirming the position prior to inflating the feature (as shown in Fig. 6).
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.
Claim(s) 1 and 3-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Pre-Grant Publication 2019/0029750 to Maini (Maini hereinafter) in view of Nance.
Regarding claim 1, Maini teaches a device (10) for creating a puncture in a tissue comprising an elongate member (12, 16) having a puncturing portion (dilator, see e.g. paragraph 57) at a distal tip which has an energy delivery device (36, see paragraph 77), an inflatable feature (14) positioned around an outer circumference of the elongate member at a distal portion and positionable proximal of the puncturing portion (see e.g. Fig 4 with puncturing portion 16 extending distally of the inflatable portion), and a lumen (within 12) extending from a proximal end of the elongate member to the inflatable feature (see paragraphs 50, 57) in fluid communication with the inflatable feature. Maini does not explicitly teach dilating a puncture. Nance teaches another trans-septal sheath generally, and particularly teaches that an inflatable sheath (1300) is advanced to a target point (502), forms a puncture (paragraph 85), advances through the puncture and expands an inflatable anchor (see Figs. 6 and 7). Nance further teaches that radially dilated punctures heal more completely (paragraph 89). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to use a dilator balloon as taught by Nance to dilate the puncture of Maini in order to allow for improved healing.
Regarding claim 3, Maini teaches a balloon (14).
Regarding claims 4 and 6, Maini teaches that the balloon may be formed of PET (paragraph 76), which applicant considers to function as claimed (see paragraph 33 of applicant’s specification).
Regarding claim 5, Maini teaches that the balloon inflates to a diameter of at least 4 mm (starting from 2-13.3mm, or 6-40 Fr, paragraph 46). The examiner notes that the balloon need only have a diameter of 4mm at some point during the inflation process to anticipate this claim.
Regarding claim 7, Maini teaches that the inflatable feature may have diameters of at least 20 mm (see paragraph 76, “Overhanging balloon 14 may be in the range of, but not limited to, 5-20 mm). It has been 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. In this case, the difference between the device of Maini and that of the claimed invention is a diametric difference of 5 mm. The examiner is further unaware of any evidence of record suggesting that this difference in size provides any difference in performance.
Regarding claim 8, Maini teaches that the elongate member may comprise a layer of insulation (see paragraph 103).
Regarding claims 9-10, Maini teaches that the insulation is positioned under the inflatable feature or over the feature (due to its polymeric composition, see e.g. paragraph 76).
Regarding claim 11, Maini teaches a core wire (20) surrounded by the lumen (12).
Regarding claim 12, Maini teaches a core wire (20) directly surrounded by a lumen in the dilator (16, see Fig. 5) positioned on the outer surface of the wire.
Regarding claim 13, Maini teaches radiopaque markers (24, 28).
Regarding claims 14-16, Maini teaches that there may be multiple markers (28) positioned proximally (on the sheath 12) and distally (on the dilator) to the inflatable feature (see paragraph 74).
Claim(s) 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Pre-Grant Publication 2008/0243081 to Nance et al. (Nance) in view of US Pre-Grant Publication 2010/0191232 to Boveda (Boveda).
Regarding claim 19, Nance teaches another trans-septal sheath generally, and particularly teaches that an inflatable sheath (1300) is advanced to a target point (502), forms a puncture (paragraph 85), advances through the puncture and expands an inflatable anchor (see Figs. 6 and 7). Nance is silent to positioning within a pulmonary vein. Boveda teaches that a transeptal catheter may be positioned in a pulmonary vein (see Fig. 14, PV) so as to treat atrial fibrillation (paragraph 14). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to position the sheath of Nance into a pulmonary vein as taught by Boveda in order to treat atrial fibrillation. Additionally, Boveda teaches using an inflatable member (50) to anchor within a pulmonary vein.
Regarding claim 20 Nance teaches using a radiopaque marker (e.g. 508) and visualizing and confirming the position prior to inflating the feature (as shown in Fig. 6).
Response to Arguments
Applicant's arguments filed 4 December 2025 have been fully considered but they are not persuasive.
With respect to the argument that Maini does not teach dilation of the puncture, this limitation is addressed by citation to Nance as discussed above.
With respect to the argument that Nance does not teach an inflatable feature to dilate the puncture, the examiner is not persuaded. In discussing Fig. 6, Nance states “[t]he dilator 306 is… a catheter with a dilatation balloon… affixed to a dilator shaft” (paragraph 88). Nance also refers to inflation thereof. The examiner finds no limitation in the claim which distinguishes from this teaching.
As an aside, the examiner notes that applicant’s amendments to claim 17 eliminate references to the pulmonary vein. As such, Nance is cited herein as anticipatory of claims 17-18. This change in rejection should not be taken to imply any concession regarding the previous rejection.
In view of the above, the examiner maintains the rejections as discussed above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHILIP E STIMPERT whose telephone number is (571)270-1890. The examiner can normally be reached Monday-Friday, 8a-4p.
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, Chelsea Stinson can be reached at 571-270-1744. 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.
/PHILIP E STIMPERT/Primary Examiner, Art Unit 3783 15 May 2026
