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 .
Election/Restriction
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1- 10, drawn to an apparatus, classified in A61F2/2463.
II. Claims 11- 20, drawn to a system, classified in A61B17/00234.
The inventions are independent or distinct, each from the other because:
Inventions II and I are related as combination and subcombination. Inventions in this relationship are distinct if it can be shown that (1) the combination as claimed does not require the particulars of the subcombination as claimed for patentability, and (2) that the subcombination has utility by itself or in other combinations (MPEP § 806.05(c)). In the instant case, the combination as claimed does not require the particulars of the subcombination as claimed because the combination does not require a handle assembly. The subcombination has separate utility such as a clip for treating mitral valve prolapse by clipping mitral valve leaflets to one another.
The examiner has required restriction between combination and subcombination inventions. Where applicant elects a subcombination, and claims thereto are subsequently found allowable, any claim(s) depending from or otherwise requiring all the limitations of the allowable subcombination will be examined for patentability in accordance with 37 CFR 1.104. See MPEP § 821.04(a). Applicant is advised that if any claim presented in a continuation or divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
(a) the inventions require a different field of search (for example, searching different classes/subclasses or electronic resources, or employing different search queries);
(b) the prior art applicable to one invention would not likely be applicable to
another invention.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Erik T. Nyre on 1/23/26 a provisional election was made without traverse to prosecute the invention of Group I, claims 1- 10, drawn to apparatus. Affirmation of this election must be made by applicant in replying to this Office action. Claims 11- 20 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancellation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore,
“a closed loop structure” in claim 1.
must be shown or the feature(s) canceled from the claim(s). No new matter should be entered. It is noted that P. [0073] of the Specification of the instant applicant states, “In some embodiments, wings 208a and 208b can connect to form a closed loop (not shown) in place of distal connecting member 206.”
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 10 is objected to because of the following informalities: lines 2- 3- “at least a distal portion of the closed loop structure is positioned with a bladder” should be amended to - - at least a distal portion of the closed loop structure is positioned [[with]] within a bladder - - . Appropriate correction is required.
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 connected curved portions (C1, C2) (See Annotated Fig. 1B - - encircled portions) that form a closed loop structure (CL) (See Annotated Fig. 1B - - periphery/perimeter of expandable tissue engagement structure, 100a, 100b, 100d, 100e, 100f, 100g are represented by dashed lines) 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, C2) 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, C2) 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).
Regarding claim 3, Bachar further discloses wherein a proximal portion (304a, 304b) (Figs. 3A, 3B) of the closed loop structure (CL) 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).
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 closed loop structure (CL) 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).
Regarding claim 6, Bachar further discloses wherein the closed loop structure (CL) comprises arms (102a, 102b) (Figs. 1A, 1B) and the curved portions (C1, C2) 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 7, Bachar further discloses wherein the arms (102a, 102b) are connected by a distal connecting member (Ps. [0085], [0086] - - Protrusions 102a and 102b may be integrally formed with distal connectors 100d,100e).
Regarding claim 8, Bachar further discloses wherein the curved portions (C1, C2) have connected distal ends (See Annotated Fig. 1B) (Ps. [0084], [0092] - - 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; the cross-section at the ends of the open device may be circular due to the normally-open circular arc-shape of connector pairs 100d, 100e as shown in Figs. 1A, 1D).
Regarding claim 9, Bachar further discloses wherein the closed loop structure (CL) is 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 closed loop structure (CL) is positioned with 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
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 Monday- Friday: 10:00- 5:00 MT.
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, (Jackie) Tan-Uyen Ho can be reached at 571 272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KANKINDI RWEGO/Primary Examiner, Art Unit 3771