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 .
Response to Amendment
The Amendment filed 5/19/26 has been entered. Claims 1, 3, 5- 6 and 9- 10 are amended. Claims 7-8 and 18- 19 are canceled. Claims 11- 17 and 20 have been previously withdrawn and remain withdrawn as being directed to a non-elected invention.
Response to Arguments
Applicant’s amendment has obviated the drawings objections and the claim objections made in the Non-Final Rejection, mailed 2/19/26. As such, the claim objections made in the Non-Final Rejection, mailed 2/19/26 are withdrawn. Claims 1- 6 and 9-10 are being addressed by this Action.
Applicant’s arguments, see pp. 6- 7 of applicant’s Remarks, filed 5/19/26, with respect to the rejection(s) of claim(s) 1- 10 under35 U.S.C. 102 as being anticipated by Bachar have been fully considered and are persuasive because the interpretation of Bachar in the Non-Final Office Action, mailed 2/19/26 does not disclose the newly added claim language regarding curved portions being connected at a distal-most end. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of a different interpretation of Bachar described in the below rejection.
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) 1- 10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bachar (US Pub. No. 2017/0000598 A1). Bachar is cited in the IDS filed 11/18/24.
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Regarding claim 1, Bachar discloses a treatment device for engaging and manipulating a lobe of a prostate gland, comprising:
an elongate tissue access assembly (306) (Figs. 3A, 3B) coupled to a handle assembly (HA) (See Annotated Fig. 4A), wherein the elongate tissue access assembly (306) is configured to be inserted within an introducer sheath (308) (Figs. 3A, 3B) (P. [0111] - - a cystoscope 420 disposed with a work channel 422 may be used for deploying device 300 of FIGS. 3A-B from the distal end 428 of cystoscope 420. Device 300 housed within deployment lumen 308 and optionally with alignment lumen 310 may be inserted into work channel 422); and
an expandable tissue engagement structure (100, 300) (Figs. 1A- 1D, 3A, 3B) coupled to a distal end portion of the elongate tissue access assembly (306) (See Fig. 3A) (Ps. [0081], [0106] - - FIGS. 1 through 5, wherein like parts are designated by like reference numerals throughout, illustrate a dilating device for the prostatic urethra, and a method of use according to the present invention; Reference is now made to FIGS. 3A-B which together illustrate an apparatus for deploying a dilating device for the prostatic urethra, in accordance with an embodiment; it is noted that the structure having reference number 100 is the same as the structure having reference number 300, the only difference being that the structure having reference number 100 has more details/elements than the more generic structure having reference number 300), wherein the expandable tissue engagement structure (100, 300) comprises curved portions (C1- A, C1- B, C2- A, C2- B) (See Annotated Fig. 1B - - encircled portions) connected at a distal-most end (C1- DME, C2- DME) thereof configured to transition from a contracted state (Fig. 3B) to an expanded state (Fig. 3A) upon exiting a distal end (314) (Fig. 3B) of the introducer sheath (308).
Regarding claim 2, Bachar further discloses wherein the curved portions (C1- A, C1- B, C2- A, C2- B) are biased away from a midline defined by a longitudinal axis (“A”) (See Annotated Fig. 3A) of the elongate tissue access assembly (306) such that the curved portions (C1- A, C1- B, C2- A, C2- B) are compressed toward the midline when positioned within the introducer sheath (308) (See Fig. 3B) and expand away from the midline when positioned outside the introducer sheath (308) (See Annotated Fig. 3A) (Ps. [0082], - - Device 100 may be normally-open, and may be configured to laterally compress, causing the distance between ridges 100a, 100b, 100c to decrease, thereby enabling the insertion of device 100 into the prostatic urethra in a compressed configuration, and to laterally expand to its normally-open configuration, causing the distance between ridges 100a, 100b, 100c to increase, upon deployment within the prostatic urethra; it is noted curved portion (C1- A, C1- B, C2- A, C2- B) are directly connected to ridges 100a, 100b, such that they move with ridges 100a, 100b).
Regarding claim 3, Bachar further discloses wherein a proximal portion (304a, 304b) (Figs. 3A, 3B) of the curved portions (C1- A, C1- B, C2- A, C2- B) is coupled to the elongate tissue access assembly (306) (P. [0109] - - Dilating device 300 may be provided with one or more proximally disposed protrusions 304a and 304b that are that may be integrally formed with the proximal end of device 300 and that are configured to releasably connect device 300 to an alignment mechanism 306 that is configured for being housed within deployment lumen 308 as shown in Fig. 3A; it is noted curved portions (C1- A, C1- B, C2- A, C2- B) are indirectly coupled to elongate tissue access assembly (306) via at least ridges 100a, 100b).
Regarding claim 4, Bachar further discloses wherein at least a portion of the expandable tissue engagement structure (100, 300) is configured to be visualized using a cystoscope (See Fig. 5 - - showing an aligning step) (P. [0115] - - A torque may be applied to align the device via an alignment mechanism connected to the device … where alignment may comprise aligning a central ridge of the device for engaging with the anterior inter-lobar groove of the prostatic urethra and aligning two peripheral ridges of the device to each engage with a different postero-lateral groove of the prostatic urethra (Step 506). The application of the torque may be guided via a cystoscope).
Regarding claim 5, Bachar further discloses wherein movement of the curved portions (C1- A, C1- B, C2- A, C2- B) is constrained to be along a longitudinal axis (“LA”) (See Annotated Fig. 1B- - solid line along center of expandable engagement structure) of the elongate tissue access assembly (100, 300) (Ps. [0082], [0084], [0091] - - Device 100 may be normally-open, and may be configured … to laterally expand to its normally-open configuration, causing the distance between ridges 100a, 100b, 100c to increase, upon deployment within the prostatic urethra; Two distal connectors 100d, 100e may branch out from a V-shaped distal end of central ridge 100c and laterally connect to the distal ends of peripheral ridges 100a and 100b, respectively; When normally-open, S-shaped distal connectors 100d, 100e, comprising a distal end of device 100, may be configured to span an arc, such as a portion of a circle to dilate the prostatic urethra at the bladder neck; it is noted that since 100d and 100e form a v- shaped distal end of central ridge 100c, laterally expanding movement of the closed loop structure (CL1, CL2) is constrained to be along a longitudinal axis (“LA”) of the elongate tissue access assembly (100, 300) as shown in Figs. 1A, 1D, 3A, Annotated Fig. 1B; it is noted curved portions (C1- A, C1- B, C2- A, C2- B) are directly connected to ridges 100a, 100b, such that they move with ridges 100a, 100b).
Regarding claim 6, Bachar further discloses wherein the curved portions (C1- A, C1- B, C2- A, C2- B) comprise wings (See Annotated Fig. 1B) (Ps. [0084], [0090] - -In the embodiment of FIG. 1A, connectors 100d, 100e, 100f, and 100g may be substantially S-shaped, forming a butterfly shape by device 100 when in the normally-open configuration, where proximal connectors 100f, and 100g may be configured for positioning towards the distal end of the prostate urethra; The closed form that is formed by peripheral ridge 100b, central ridge 100c, distal connector 100e, and proximal connector 100g resembles a ‘butterfly wing’. An identical and symmetric butterfly wing (not shown) is formed by peripheral ridge 100a, central ridge 100c, distal connector 100d, and proximal connector 100f; it is noted that “protrusions” is broadly interpreted as “arms”).
Regarding claim 9, Bachar further discloses wherein the curved portions (C1- A, C1- B, C2- A, C2- B) are configured to engage and manipulate a prostate gland in the expanded state (P. [0116] - - The aligned device may be positioned in the prostate urethra, such as by pulling on the deployment mechanism to draw the device in from the bladder into the prostate urethra (Step 508) … The device, thus deployed and aligned within the prostatic urethra, may exert an outwards radial force that pushes the inter-lobar grooves of the urethra outwards, and dilate the urethra (Step 512).
Regarding claim 10, Bachar further discloses wherein the elongate tissue access assembly (100, 300) is configured such that upon insertion within a urethra, at least a distal portion of the curved portions (C1- A, C1- B, C2- A, C2- B) is positioned within a bladder (Ps. [0085], [0116] - - Device 100 may be provided with two, or more distally positioned protrusions 102a and 102b that are configured to impinge against the postero-lateral side of the bladder neck, and prevent a migration of device 100 into the urinary bladder; Two protrusions disposed at the distal end of the device may be caused to impinge against the postero-lateral side of the bladder neck, thereby securing the position of the device, and preventing a migration of the device into the urinary bladder (Step 510)).
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 KANKINDI RWEGO whose telephone number is (303)297-4759. The examiner can normally be reached Tuesdays and Wednesdays, 9:00a- 5:00p PST.
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/KANKINDI RWEGO/ Primary Examiner, Art Unit 3771
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