DETAILED ACTION
This action is in response to the amendment filed 11/14/2025. Currently, claims 1-16 are pending in the application. Claims 17-20 are cancelled by Applicant.
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 Arguments
Applicant’s amendment to the specification is sufficient to overcome the previous objection to the specification.
Applicant’s amendment to claim 15 is sufficient to overcome the previous rejection of claim 15 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph.
In response to Applicant’s argument that Arias et al. does not teach a device body that is releasable coupleable to a delivery catheter, the examiner respectfully disagrees. As detailed below, Arias et al. teaches in the abstract, [0011], [0023-0025], [0028-0029] and Figures 1-4 and 8A and a device body (wire loop 22, outer tube 24, proximal second handle 26) releasably ([0024] teaches “the wire loop 22 is elastically expansible and collapsible;” [0025] teaches “an outer tube 24 is provided over and slidably displaceable relative to the shaft 12;” [0029] teaches “distally advancing the second handle 26 relative to the first handle 12 to cause the outer tube to collapse the wire loop 22” and “the second handle 26 is retracted relative to the first handle 12 to permit the loop 22 to expand;” thus, advancement or retraction of the second handle 26 functions to release the device body from position relative to the shaft 14) couplable to (see Figures 1-4; [0023] teaches “a flexible wire loop 22, described in detail below, is coupled to the distal end 18 of the shaft 14;” [0025] teaches “an outer tube 24 is provided over and slidably displaceable relative to the shaft 12”) a delivery catheter (shaft 14; [0023] teaches “the shaft 14, seen best in FIG. 3, is preferably a rigid tubular element” and thus, constitutes a catheter).
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., that the device body is removably coupled to the delivery catheter; that the device body is not fixed or secured to the delivery catheter) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In response to Applicant’s argument that Arias et al. does not teach at least one abrasive surface coupled to the device body, the examiner again respectfully disagrees. As Applicant notes, the Office interprets the smaller surface 52a of Arias et al. as corresponding to the claimed at least one abrasive surface. However, Applicant argues that the smaller surface 52a of Arias et al. is not abrasive and instead, is simply taught to be a sharp surface. In response, the Office holds that a sharp surface such as the smaller surface 52a of Arias et al. can reasonably be considered “abrasive” inasmuch as it is capable of cutting and causing damage or abrasion.
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) 1-4 and 7-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Arias et al. (US 2011/0301598).
In regards to claim 1, Arias et al. teaches in the abstract, [0011], [0023-0025], [0028-0029] and Figures 1-4 and 8A and a device body (wire loop 22, outer tube 24, proximal second handle 26) releasably ([0024] teaches “the wire loop 22 is elastically expansible and collapsible;” [0025] teaches “an outer tube 24 is provided over and slidably displaceable relative to the shaft 12;” [0029] teaches “distally advancing the second handle 26 relative to the first handle 12 to cause the outer tube to collapse the wire loop 22” and “the second handle 26 is retracted relative to the first handle 12 to permit the loop 22 to expand;” thus, advancement or retraction of the second handle 26 functions to release the device body from position relative to the shaft 14) couplable to (see Figures 1-4; [0023] teaches “a flexible wire loop 22, described in detail below, is coupled to the distal end 18 of the shaft 14;” [0025] teaches “an outer tube 24 is provided over and slidably displaceable relative to the shaft 12”) a delivery catheter (shaft 14; [0023] teaches “the shaft 14, seen best in FIG. 3, is preferably a rigid tubular element” and thus, constitutes a catheter), the device body (wire loop 22, outer tube 24, proximal second handle 26) having a lumen (the hollow interior of outer tube 24) passing therethrough, the device body (wire loop 22, outer tube 24, proximal second handle 26) being moveable (as shown in Figures 2-4; the abstract teaches “an outer tube is longitudinally displaceable over the shaft to collapse and permit expansion of the wire loop;” [0024] teaches “wire loop 22 is elastically expansible and collapsible;” [0024] teaches “permitting the loop to be collapsed for introduction;” [0025] teaches “the wire loop 22 is permitted to fully open into the expanded configuration”) between a first profile (collapsed configuration shown in Figure 4) and a second profile (“expanded configuration” shown in Figure 2; see [0024-0025]); at least one abrasive surface (smaller surface 52a) coupled to the device body (wire loop 22, outer tube 24, proximal second handle 26) and configured to create trauma to a wall of the fallopian tube to produce a wound healing response ([0028] teaches “when the loop is cinched closed on tissue, the smaller surface 52a facing into the loop functions like a knife to cut through the tissue;” capable of being cinched closed on a wall of the fallopian tube); at least one conductive surface (surface of wire loop 22; [0011] teaches “the wire loop is energized with power from an electrosurgical generator to cauterize the tissue”) on or in (interpreted to be part of) the device body (wire loop 22, outer tube 24, proximal second handle 26) and configured to transmit energy from an energy source ([0023] teaches “wire loop 22 is electrically coupled to the cautery connector 20 through the shaft 14” and “a cautery connector 20 is coupled to the first handle 12 for connection to a standard electrosurgical generator 21;” see also [0029]) to the wall of the fallopian tube (wire loop 22 is capable of being positioned in a fallopian tube).
In regards to claim 2, Arias et al. teaches the apparatus of claim 1. Arias et al. teaches in Figures 2 and 4 and [0024-0025] that the first profile (collapsed configuration shown in Figure 4) is a low profile (“fully collapsed,” as taught in [0025]) to facilitate minimally invasive insertion of the implantable device (electrocautery cutting instrument 10) into the fallopian tube ([0025] teaches “when the outer tube 24 is moved into a fully distal position, the wire loop is fully collapsed within the outer tube to permit the distal end of the instrument to be introduced or removed through a port and into the patient for purposes of the surgical procedure, as shown in FIG. 4”), wherein the second profile (“expanded configuration” shown in Figure 2; see [0024-0025]) is a higher profile (“expanded,” as taught in [0025]) than (as shown in Figured 2 and 4) the first profile (collapsed configuration shown in Figure 4).
In regards to claim 3, Arias et al. teaches the apparatus of claims 1 and 2. Arias et al. teaches in Figures 2 and 4 and [0024-0025] that in the second profile (“expanded configuration” shown in Figure 2; see [0024-0025]), the device body (wire loop 22, outer tube 24, proximal second handle 26) increases in a planar dimension such that when located inside the fallopian tube the device body (wire loop 22, outer tube 24, proximal second handle 26) flattens the fallopian tube ([0025] teaches “as shown in FIG. 2, when the outer tube is in a relatively proximal position, second handle 26 is positioned adjacent the first handle 20, and the wire loop 22 is permitted to fully open into the expanded configuration;” see Figure 2, which teaches the wire loop 22 having a planar dimension when in the expanded configuration, such that it would flatten the fallopian tube when located therein; planar configuration also explicitly taught in [0024]).
In regards to claim 4, Arias et al. teaches the apparatus of claim 1. Arias et al. teaches in Figures 2-4 and [0025] that the device body (wire loop 22, outer tube 24, proximal second handle 26) comprising a plurality of lumens passing therethrough (wire loop 22/outer tube 24/proximal second handle 26 includes the hollow interior of outer tube 24 and the hollow interior of proximal second handle 26; see [0025] and Figures 2-4).
In regards to claim 7, Arias et al. teaches the apparatus of claim 1. Arias et al. teaches in [0023] the device body (wire loop 22, outer tube 24, proximal second handle 26) being flexible ([0023] teaches “flexible wire loop 22”) to allow insertion of the implantable device (electrocautery cutting instrument 10) into a tortuous path of a fallopian tube over a flexible guidewire (the wire loop 22 is flexible such that it is capable of being inserted into a tortuous path of a fallopian tube over a flexible guidewire).
In regards to claim 8, Arias et al. teaches the apparatus of claim 1. Arias et al. teaches in Figures 1-5 at least one hinged element (wire loop 22; [0026-0027] teaches the wire loop 26 being hinged at “a sequence of bends;” also shown in Figure 5) located on (inasmuch as it is part of) the device body (wire loop 22, outer tube 24, proximal second handle 26), where movement of the at least one hinged element (wire loop 22) away from ([0025] teaches “as shown in FIG. 2, when the outer tube is in a relatively proximal position, second handle 26 is positioned adjacent the first handle 20, and the wire loop 22 is permitted to fully open into the expanded configuration”) the device body (wire loop 22, outer tube 24, proximal second handle 26) causes the device body (wire loop 22, outer tube 24, proximal second handle 26) to assume the second profile (“expanded configuration” shown in Figure 2; see [0024-0025]).
In regards to claim 9, Arias et al. teaches the apparatus of claims 1 and 8. Arias et al. teaches in [0028] that the at least one abrasive surface (smaller surface 52a) is on (as taught in [0028]) the at least one hinged element (wire loop 22).
In regards to claim 10, Arias et al. teaches the apparatus of claim 1. Arias et al. teaches in [0028] that the at least one abrasive surface (smaller surface 52a) further comprising a cutting element ([0028] teaches “when the loop is cinched closed on tissue, the smaller surface 52a facing into the loop functions like a knife to cut through the tissue”).
In regards to claim 11, Arias et al. teaches the apparatus of claim 1. Arias et al. teaches in Figure 8A that the at least one abrasive surface (smaller surface 52a) is located on an edge of (as shown in Figure 8A) the device body (wire loop 22, outer tube 24, proximal second handle 26) when in the second profile (“expanded configuration” shown in Figure 2; see [0024-0025]), where rotation of the device body (“expanded configuration” shown in Figure 2; see [0024-0025]) causes the at least one abrasive surface (smaller surface 52a) to create trauma to the wall of the fallopian tube ([0028] teaches that the smaller surface 52a can “cut through the tissue;” thus, the smaller surface 52a is capable of being rotated such that it cuts the wall of the fallopian tube to create trauma).
In regards to claim 12, Arias et al. teaches the apparatus of claim 1. Arias et al. teaches in [0024] that the at least one conductive surface (surface of wire loop 22) is configured to transmit RF energy ([0024] teaches that the wire loop 22 is made of nickel titanium, which is a metal alloy that is capable of transmitting RF energy).
In regards to claim 13, Arias et al. teaches the apparatus of claim 1. Arias et al. teaches in [0011] that the energy transmitted by the at least one conductive surface (surface of wire loop 22) is sufficient to ablate tissue in the fallopian tube ([0011] teaches “the wire loop is energized with power from an electrosurgical generator to cauterize the tissue”).
In regards to claim 14, Arias et al. teaches the apparatus of claims 1 and 13. Arias et al. teaches in [0011] and [0029] that a duty cycle of the energy source ([0023] teaches “wire loop 22 is electrically coupled to the cautery connector 20 through the shaft 14” and “a cautery connector 20 is coupled to the first handle 12 for connection to a standard electrosurgical generator 21;” see also [0029]) is sufficient to ablate a mucosal layer and an underlying muscle layer of the fallopian tube ([0011] teaches “the wire loop is energized with power from an electrosurgical generator to cauterize the tissue;” capable of ablating a mucosal layer and an underlying muscle layer of the fallopian tube, depending on the configuration of an individual user’s anatomy).
In regards to claim 15, Arias et al. teaches the apparatus of claims 1 and 13. Arias et al. teaches in [0011] and [0029] that a duty cycle of the energy source ([0023] teaches “wire loop 22 is electrically coupled to the cautery connector 20 through the shaft 14” and “a cautery connector 20 is coupled to the first handle 12 for connection to a standard electrosurgical generator 21;” see also [0029]) is sufficient to ablate tissue at a depth of 0.25 mm to 1 mm ([0011] teaches “the wire loop is energized with power from an electrosurgical generator to cauterize the tissue;” capable of ablating tissue at a depth of at least 0.25 mm, depending on the configuration of an individual user’s anatomy; this depth encompasses the claimed depth of 0.25 mm to 1 mm).
In regards to claim 16, Arias et al. teaches the apparatus of claim 1. Arias et al. teaches in Figures 2-4 that the implantable device (electrocautery cutting instrument 10) is configured for advancement over a guidewire that extends through (note: this is an intended use claim limitation; a guidewire is capable of being positioned within the hollow interior of outer tube 24 and therefore, the electrocautery cutting instrument 10 is capable of being advanced over said guidewire) the lumen (the hollow interior of outer tube 24) of the device body (wire loop 22, outer tube 24, proximal second handle 26) and into the fallopian tube (the electrocautery cutting instrument 10 is structured such that it is capable of being inserted into the fallopian tube when in the collapsed configuration shown in Figure 4;[0002] teaches “this invention relates to electrosurgical cutting instruments for use in obstetrics and gynecological procedures;” [0007] teaches “an electrocautery cutting instrument suitable for use gynecological surgical procedures is provided;” [0023] teaches “an electrocautery cutting instrument 10 suitable for use in gynecological surgical procedures is provided”).
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) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arias et al. (US 2011/0301598) in view of Truckai (US 2016/0030109 A1).
In regards to claim 5, Arias et al. teaches the apparatus of claim 1. Arias et al. does not teach that the implantable device is fabricated at least partly of micro-porous polymeric material that allows for tissue in-growth such that the implantable device serves as a scaffold.
However, Truckai teaches in [0071] and Figure 7 an analogous device wherein the implantable device is fabricated at least partly of micro-porous polymeric material (porous, microporous or nanoporous implant 560; [0071] teaches “such an implant 560 can carry a pharmacological agent adapted to accelerate fibrosis in the treated segment” and “any suitable polymers can be used that are infused with pharmacological agents”) that allows for tissue in-growth such that the implantable device serves as a scaffold ([0071] teaches “such an implant 560 can carry a pharmacological agent adapted to accelerate fibrosis in the treated segment;” fibrosis would provide for tissue in-growth within the implant 560, causing the implant 560 to serve as a scaffold).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the implantable device of Arias et al. to further include that the implantable device is fabricated at least partly of micro-porous polymeric material that allows for tissue in-growth such that the implantable device serves as a scaffold as taught by Truckai because this element is known “to accelerate fibrosis in the treated segment” “following an abrading step,” as Truckai teaches in [0071].
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arias et al. (US 2011/0301598) in view of Payne et al. (US 2008/0154256 A1).
In regards to claim 6, Arias et al. teaches the apparatus of claim 1. Arias et al. does not teach that the implantable device is fabricated at least partly of bio-absorbable or bio-degradable material such that the implantable device is resorbed and replaced with tissue over time.
However, Payne et al. teaches in [0080] an analogous device wherein the implantable device is fabricated at least partly of bio-absorbable or bio-degradable material (tubal occlusion device 120; [0080] teaches “tubal occlusion device 120 is made from a biodegradable material”) such that the implantable device is resorbed and replaced with tissue over time ([0080] teaches “The material maintains its integrity for at least the first several weeks and does not begin to biodegrade to the point where tubal occlusion is compromised until the period of time required for permanent tubal occlusion by way of the ablation part of the procedure has taken effect”).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the implantable device of Arias et al. to further include that the implantable device is fabricated at least partly of bio-absorbable or bio-degradable material such that the implantable device is resorbed and replaced with tissue over time as taught by Payne et al. because this element is known to provide a mechanism that prevent tubal occlusion from being compromised before permanent tubal occlusion by way of the ablation part of the procedure has taken effect, as Payne et al. teaches in [0080].
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 VICTORIA H FISHER whose telephone number is (571)270-7033. The examiner can normally be reached M-TH 6:00AM-4:00PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rachael Bredefeld can be reached at (571) 270-5237. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/VICTORIA HICKS FISHER/Primary Examiner, Art Unit 3786 12/3/2025