DETAILED ACTION
Note: The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s arguments filed in the reply on August 7, 2025 were received and fully considered. Claim 1 was amended. Claims 32 and 33 are new. The current action is FINAL. Please see corresponding rejection headings and response to arguments section below for more detail.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-7, 13, 14, 16, 32, and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Gerber et al. (US PG Pub. No. 2006/0247725 A1) (hereinafter “Gerber”)
With respect to claim 1, Gerber teaches an implant delivery system (par.0078 “deployment of an implantable pressure sensor 12”; Figs. 8-11) comprising: an implant configured to measure pressure (par.0078 “pressure sensor 12” measures pressure); a first sheath (deployment device 68 in Figs. 8-11) and a second sheath (delivery sheath 69 in Figs. 8-11), wherein said first sheath is positioned at least partially within said second sheath (deployment device 68 is placed in/on delivery sheath 69 as depicted in Figs. 8-11), the first sheath is translatable relative to said second sheath and wherein the first sheath comprises an exterior circumference (first sheath 68 translates with respect to delivery sheath 69 during deployment of pressure sensor 12 as depicted in Figs. 8-9); wherein said implant is removably mounted directly on the exterior circumference of said first sheath and is deployable from the exterior circumference such that said implant separates from the exterior circumference of said first sheath (Fig. 8 shows that implantable pressure sensor 12 is mounted to the exterior of deployment device 68; Fig. 9 shows that implantable pressure sensor 12 separates from exterior of deployment device 68), and wherein said first sheath and said second sheath are movable with respect to one another (Figs. 8-9 show first sheath 68 and second sheath 69 are movable with respect to one another) to deploy and release said implant to a target site in an anatomy (Fig. 9 depicts implant 12 is released and placed against the mucosal wall 44 of bladder 24; see par.0082); and further wherein said first sheath is configured to be partially inserted into a living body (Figs. 8-9 show first sheath 68 is inserted within bladder 24) such that a proximal end of said second sheath remains external to said living body (Figs. 8-9 shows proximal end of second sheath 69 remains external to living body) and a distal end of said first sheath is internal to said living body (Figs. 8-9 show first sheath 68 is internal to bladder 24).
Although Gerber’s Figs. 8-9 do not explicitly show wirelessly communicate information to a receiver or reader device, further modification to include this feature would have been prima facie obvious to person having ordinary skill in the art at the time of invention for at least several reasons. First, Gerber, in other embodiments, discloses utilizing wireless telemetry with an external programmer (par.0077, 0098). Examiner also notes that it is widely known1, in various implant medical monitoring applications, to utilize wireless communication means in order to transmit obtained physiological signals to external user devices such as mobile phones, computers, etc. Therefore, PHOSITA would have had predictable success modifying Gerber’s embodiments, as depicted in Figs. 8-9, to incorporate wireless communication in order to transmit sensed pressure signals from the target site to an external device, as suggested by Gerber (par.0077, 0098), and as widely known in the various other implantable medical monitoring applications.
With respect to claim 2, Gerber teaches wherein said first sheath is configured to be partially inserted into a blood vessel of said living body such that said proximal end of said second sheath remains external to said living body and said distal end is internal to said living body (Figs. 8-11).
With respect to claim 3, Gerber teaches further comprising at least one fluid port positioned along a proximal end of said first sheath or second sheath, said fluid port fluidly coupled to at least one lumen extending down a length of said first sheath or second sheath to allow fluid flow through said lumen (par.0044-0052).
With respect to claim 4, Gerber teaches wherein said fluid is injected through said port and includes one of: a drug; a fluid used to enhance anatomical imaging; fluoroscopic contrast dye; barium; a radioactive material; blood; plasma; saline solution; a blood component; a particle suspension; a nano-device; and a nanomaterial (par.0051).
With respect to claim 5, Gerber teaches wherein said at least one fluid port is configured to operatively couple to a device located outside of said body (par.0044-0052).
With respect to claim 6, Gerber teaches wherein said device is a pressure transducer, configured to measure a fluid pressure at the distal end of said first sheath or a distal end of said second sheath (par.0044-0052).
With respect to claim 7, Gerber teaches wherein said measurement of fluid pressure at the distal end of said first or second sheath is used to calibrate or assess accuracy of said implant (par.0044-0052).
With respect to claim 13, Gerber teaches wherein: said second sheath is configured to allow insertion of a catheter configured to selectively attach to said implant and move said implant proximally when retracted; wherein at least one anchor of said implant is collapsible; and wherein said anchor of said implant is configured to be placed in a collapsed state when said catheter moves the implant proximally into said second sheath (par.0084, 0086).
With respect to claim 14, Gerber teaches wherein said second sheath is configured to allow said first sheath to be retracted into said second sheath while said implant is still connected to said first sheath, and configured to cover said first sheath and said implant while said first and second sheath are withdrawn from said living body (par.0084, 0086).
With respect to claim 16, Gerber teaches wherein said implant further comprises a rigid housing, and at least one collapsible implant anchor, said at least one anchor being attached to said housing (par.0084, 0086).
With respect to claim 32, Gerber teaches an implant delivery system (par.0078 “deployment of an implantable pressure sensor 12”; Figs. 8-11) comprising: an implantable pressure sensor (par.0078 “pressure sensor 12”); a first sheath (deployment device 68 in Figs. 8-11) and a second sheath (delivery sheath 69 in Figs. 8-11), wherein the first sheath is translatable relative to the second sheath and wherein the first sheath comprises an exterior circumference (first sheath 68 has an exterior circumference and translates with respect to delivery sheath 69 during deployment of pressure sensor 12 as depicted in Figs. 8-9); wherein the implantable pressure sensor is removably mounted directly on the exterior circumference of the first sheath and is deployable from the exterior circumference such that the implantable pressure sensor separates from the exterior circumference of the first sheath (Fig. 8 shows that implantable pressure sensor 12 is mounted to the exterior of deployment device 68; Fig. 9 shows that implantable pressure sensor 12 separates from exterior of deployment device 68), and wherein the first sheath is configured to be partially inserted into a living body such that a proximal end of the second sheath remains external to the living body (Figs. 8-9 shows proximal end of second sheath 69 remains external to living body) and a distal end of the first sheath is internal to the living body (Figs. 8-9 show first sheath 68 is internal to bladder 24).
Although Gerber’s Figs. 8-9 do not explicitly show wirelessly communicate information to a receiver or reader device, further modification to include this feature would have been prima facie obvious to person having ordinary skill in the art at the time of invention for at least several reasons. First, Gerber, in other embodiments, discloses utilizing wireless telemetry with an external programmer (par.0077, 0098). Examiner also notes that it is widely known2, in various implant medical monitoring applications, to utilize wireless communication means in order to transmit obtained physiological signals to external user devices such as mobile phones, computers, etc. Therefore, PHOSITA would have had predictable success modifying Gerber’s embodiments, as depicted in Figs. 8-9, to incorporate wireless communication in order to transmit sensed pressure signals from the target site to an external device, as suggested by Gerber (par.0077, 0098), and as widely known in the various other implantable medical monitoring applications.
With respect to claim 33, Gerber teaches further comprising at least one fluid port positioned along a proximal end of the first or second sheaths, the at least one fluid port fluidly coupled to at least one lumen to allow fluid flow through the lumen (par.0044-0052).
Claims 8-10 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Gerber, as applied to claim 1 above, in further view of Stalker et al. (US PG Pub. No. 2008/0071339 A1) (hereinafter “Stalker”).
Stalker was applied in the previous office action.
With respect to claims 8-10 and 18, Gerber teaches an implant delivery system as established above.
However, Gerber does not teach the limitations recited in claims 8-10 and 18.
With respect to claim 8, Stalker teaches at least one marker configured to be visible with a fluoroscope (par.0032 “retaining element 48 may include a radio-opaque marker at or near its distal end”).
With respect to claim 9, Stalker teaches said marker comprises a radio opaque material positioned on at least one of: a distal tip of said first sheath; the distal end of said second sheath; a portion of said implant; and as a plurality of markings spaced along a portion of said first or said second sheath (par.0032 “retaining element 48 may include a radio-opaque marker at or near its distal end”).
With respect to claim 10, Stalker teaches said marker is attached to at least one anchor on the implant (par.0032 “retaining element 48 may include a radio-opaque marker at or near its distal end”; anchor 74 is presumably attached to marker 48 as depicted in Fig. 1).
With respect to claim 18, Stalker teaches said implant includes a marker configured to be at least partially visible under fluoroscopic imaging (par.0032).
Therefore, it would have been prima facie obvious to PHOSITA at the time of invention to modify Gerber to utilize a marker in the manner recited above in order to aid in accurately delivering and deploying an implant/device within a patient’s body, as evidence by Stalker (par.0005).
Claims 11, 12, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Gerber and Stalker, as applied to claim 8 above, in view of Kick et al. (US PG Pub. No. 2006/0135963 A1) (hereinafter “Kick”).
Kick was applied in the previous office action.
With respect to claims 11, 12, and 19, Gerber and Stalker teach an implant delivery system as established above.
However, Gerber and Stalker do not teach the limitations recited in claims 11, 12, and 19.
Regarding claim 11, Kick teaches a plurality of markers are positioned along said implant in an asymmetric pattern, said pattern is configured to facilitate determination of implant orientation when viewed on a fluoroscope (par.0074 “asymmetric radiopaque markers 1712 to provide rotational and longitudinal orientation information... allow for positioning under fluoroscopy”).
Regarding claim 12, Kick teaches said asymmetric pattern comprises markers at three of four corners of a two-dimensional rectangle when viewed normal to a plane of said rectangle on a fluoroscope (par.0074; see also Fig. 17).
Regarding claim 19, Kick teaches a plurality of said markers are spaced at known intervals along anchor wire of said anchor to facilitate distance estimation during angiographic imaging; and wherein said marker is located on the anchor wire near a point where said anchor wire attaches to said housing (par.0074; see also Fig. 17).
Therefore, it would have been prima facie obvious to PHOSITA at the time of invention to modify Gerber and Stalker to incorporate a plurality of markers in the recited arrangement in order to provide rotational and longitudinal orientation information, as evidence by Kick (par.0074).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Gerber, as applied to claim 1 above, in view of Mustapha (US PG Pub. No. 2010/0100055 A1).
Mustapha was applied in the previous office action.
With respect to claim 15, Gerber teaches an implant delivery system as established above.
However, Gerber does not teach the limitations recited in claim 15.
Regarding claim 15, Mustapha teaches said first sheath is configured with a distal tip made of a soft material to reduce vessel trauma during use, wherein said distal tip has a durometer softer than Shore 40A (par.0038 “the distal portion 16 provides a soft or flexible sheath portion that still provides mild support while in the vessel, which is highly suited for intervention of the vessel without substantial risk of vessel trauma”).
Therefore, it would have been prima facie obvious to PHOSITA at the time of invention to modify Gerber such that the distal tip is made of a soft material in order to provide mild support while in the vessel, which is highly suited for intervention of the vessel without substantial risk of vessel trauma, as evidence by Mustapha (see par.0038).
Conclusion
No claim is allowed.
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 PUYA AGAHI whose telephone number is (571)270-1906. The examiner can normally be reached M-F 8 AM - 5 PM.
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/PUYA AGAHI/Primary Examiner, Art Unit 3791
1 See prior art cited in previous current office action for example teachings
2 See prior art cited in previous current office action for example teachings