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 .
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 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.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 32, 34 and 36-37 are rejected under 35 U.S.C. 103 as being unpatentable over Shadduck (US 2011/0118717) in view of Hoey et al. (US 2012/0323167).
Regarding claim 32, Shadduck discloses a vapor delivery device (see Figs. 7-9), comprising: a shaft (see hypotube 360 or inner sleeve 325, Figs. 7-9) defining a plurality of vapor delivery ports (see vapor delivery ports 170, [0033], Figs. 7-9); a needle tip, wherein the needle is configured to be advanced and retracted relative to the shaft (see [0036], Fig. 9), wherein, upon advancement of the needle tip into a tissue at a target site, an exposed portion of the needle tip is distal to a distalmost end of the shaft (see [0036], Fig. 9), however Shadduck fails to teach wherein the shaft or the needle tip is configured so as to inhibit a length of the exposed portion from exceeding 15 mm.
Hoey teaches a method of vapor ablation (see Fig. 7) wherein the needle is advanced at least 15 mm into the tissue (see [0042] and [0048]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified advanceable needle as taught by Shadduck such that shaft or the needle is configured so as to inhibit the needle from advancing more than 15 mm distally past a distal end of the shaft in light of Hoey, the motivation being to properly size the exposed portion of the needle such that the needle is able to reach the targeted depth of tissue for the ablation without causing collateral damage in non-target tissue (see Hoey Fig. 7).
Regarding claim 34, Shadduck further discloses wherein the exposed portion is distal to each of the plurality of vapor delivery ports (as shown in Fig. 9).
Regarding claim 36, Shadduck further discloses a vapor source in fluid communication with the plurality of vapor delivery ports (see fluid source 140, [0033]).
Regarding claim 37, Shadduck further discloses wherein the distal tip is configured to deform a tissue of a bladder without puncturing through a thickness of the tissue (see blunt distal end in Fig. 7, the pointed distal ends as shown in Figs. 8-9 are also considered reasonably capable of providing deformation of a bladder wall without puncturing when using the lateral side of the distal tip to apply pressure or with minimal force applied).
Claim 43 is rejected under 35 U.S.C. 103 as being unpatentable over Shadduck in view of Hoey and in further view of Hoey et al. (US 2014/0324037), hereinafter Hoey ‘037.
Regarding claim 43, Shadduck in view of Hoey teaches the limitations of claim 34, however Shadduck in view of Hoey fails to further teach wherein the tissue is a bladder tissue, wherein the plurality of vapor delivery ports are arranged to ablate a surface of the bladder tissue in a concentric ring pattern while the shaft is stationary.
Hoey ‘037 teaches a vapor delivery device (see Figs. 4A-4B) wherein the shaft comprises a plurality of vapor outlets (see vapor outlets 125, [0100]-[0101], Fig. 4B), that allow vapor media to be ejected in all radial directions over a selected treatment length of the working end (see [0100]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the vapor port configuration as taught by Shadduck in view of Hoey for a plurality of vapor delivery ports that are arranged to ablate a surface of the bladder tissue in a concentric ring pattern while the shaft is stationary in light Hoey ‘037 for the purpose of ejecting vapor to treat targeted tissue in all radial directions to fully ablate an area of tissue (see Hoey ‘037 [0100]-[0101]).
Response to Arguments
Applicant's arguments filed 31 March 2026 with respect to cancelled claim 35 whose limitations are now contained within claim 32 have been fully considered but they are not persuasive.
To the extent that applicant argues Hoey discloses the opposite of the claimed subject matter (see Remarks pgs. 8-9), the examiner respectfully disagrees. The examiner contends that since the claim requires the shaft or needle to “inhibit a length of the exposed portion from exceeding 15 mm”, the “at least 15 mm” as taught by Hoey provides a sufficient teaching since “at least 15 mm” includes the value of 15 mm, which does not exceed 15 mm as set forth in claim 32. For this reason, the examiner respectfully disagrees that Hoey teaches the opposite of the claimed subject matter of claim 32 as argued by applicant.
Allowable Subject Matter
Claims 21-29, 31 and 38-42 are allowed.
The following is a statement of reasons for the indication of allowable subject matter: The closest prior art, Shadduck (US 2011/0118717) in view of Hoey et al. (US 2012/0323167), and Hoey et al (US 2014/0324037), fails to reasonably teach or suggest the requirements of claims 21 and 38 as argued by persuasively by applicant in the Remarks filed 31 March 2026, specifically with regard to the absence of the limitation requiring the distal tip being configured to anchor to the tissue, without penetrating through the tissue.
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 SEAN W COLLINS whose telephone number is (408)918-7607. The examiner can normally be reached M-F 9:00 AM-5:00 PM ET.
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, Joanne Rodden can be reached on 303-297-4276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SEAN W COLLINS/Primary Examiner, Art Unit 3794
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