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 (i.e., changing from AIA to pre-AIA ) 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 § 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, 4-7, 10-11, 13, 15-17, 19, and 21-22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Decre et al., (US 20160143555; hereinafter Decre).
Regarding claim 1, Decre (Figures 1-4C) discloses a device (130) comprising: a thin film polymer strip (301) having an electrode array (132), the thin film polymer strip (301) comprising: a thin film polymer shaped into a strip having a distal end (304) and a proximal end (310), ([0065]); a plurality of exposed electrodes (132) positioned at the distal end (304) of the thin film polymer (301), ([0072]); a plurality of bond pads (322) positioned at the proximal end (310) of the thin film polymer (301), ([0072]); and a plurality of insulated traces (320) connecting each electrode (132) of the plurality of exposed electrodes to a single, respective bond pad (322) of the plurality of bond pads ([0072]); and each insulated micro-wire (conductive tracks) having a distal wire end electrically connected to respective bond pad of the plurality of bond pads (322) of the thin film polymer strip (301) and a proximal wire end stripped of insulation configured to connect to recording or stimulation equipment (110) through an ALC element (111), ([0074]-[0075]), wherein the thin film polymer strip (301) has a helical or cylindrical shape configured to fit around a commercial vascular guide wire (302), ([0065], [0082]; [0067]-[0069]: carrier 302 and corresponding stylet/stiffener comprise the guidewire).
Regarding claim 4, Decre (Figures 1-4C) further discloses wherein the plurality of exposed electrodes (132) are composed of a metal film ([0074]).
Regarding claim 5, Decre (Figures 1-4C) further discloses wherein the metal film is composed of an electrically conductive metal, an electrically conductive metal alloy, or an electrically conductive metal oxide ([0074]).
Regarding claim 6, Decre (Figures 1-4C) further discloses wherein the metal film is composed of platinum, palladium, iridium, rhodium, ruthenium, gold, or alloys thereof ([0074]).
Regarding claim 7, Decre (Figures 1-4C) further discloses wherein the thin film polymer strip (301) having an electrode array (132) is a straight strip wrapped into a helix ([0065]).
Regarding claim 10, Decre (Figures 1-4C) further discloses wherein one or more of the plurality of exposed electrodes (132) are functionalized for biosensing ([0065], [0073]).
Regarding claim 11, Decre (Figures 1-4C) further discloses wherein the thin film polymer strip (301) having an electrode array (132) includes other embedded electrodes or sensor types ([0027]).
Regarding claim 13, Decre (Figures 1-4C) further discloses wherein the electrode array (132) is permanently attached to the commercial vascular guide wire ([0067]-[0069]: element 302 of the guidewire is permanently attached to the electrode array 132).
Regarding claim 15, Decre (Figures 1-4C) further discloses wherein an adapter (111) connects the device (130) to the recording or stimulation equipment (110), the adapter (111) including: a first side (distal side) that includes discrete connections to the proximal wire end of each insulated micro-wire (conductive tracks); and a second side (proximal side) that connects to the recording or stimulation equipment (110) via a standard connector (120/220), ([0021], [0075]).
Regarding claim 16, Decre (Figures 1-4C) further discloses wherein: the proximal wire end of each insulated micro-wire (conductive trace) is connected to implantable electronics (111); and the device (130) and the implantable electronics (111) are fully implanted ([0028], [0031], [0075]).
Regarding claim 17, Decre (Figures 1-4C) discloses a method comprising: a) inserting an endovascular device (130) into a subject, the endovascular device (130) comprising a thin film polymer strip (301) having an electrode array (132), the thin film polymer strip (301) comprising: a thin film polymer shaped into a strip having a distal end (304) and a proximal end (310), ([0065]); a plurality of exposed electrodes (132) positioned at the distal end (304) of the thin film polymer (301), ([0072]); a plurality of bond pads (322) positioned at the proximal end of the thin film polymer (301), ([0072]); and a plurality of insulated traces (320) connecting each electrode (132) of the plurality of exposed electrodes to a single, respective bond pad (322) of the plurality of bond pads ([0072]); and each insulated micro-wire (conductive traces) having a distal wire end electrically connected to a respective bond pad of the plurality of bond pads (322) of the thin film polymer strip (301) and a proximal wire end stripped of insulation configured to connect to recording or stimulation equipment (110) through an ALC element (111), ([0075]), wherein the thin film polymer strip (301) has a helical or cylindrical shape configured to fit around a commercial vascular guide wire ([0065], [0082]; [0067]-[0069]: carrier 302 and corresponding stylet/stiffener comprise the guidewire).; d) recording readings from the endovascular device (130) or stimulating the subject with the endovascular device (130), ([0019], [0073]).
Regarding claim 19, Decre (Figures 1-4C) further discloses wherein the thin film polymer strip (301) having an electrode array (132) is a straight strip wrapped into a helix ([0065]).
Regarding claim 21, Decre (Figures 1-4C) further discloses wherein the helical or cylindrical shape is configured to fit within a blood vessel having a diameter of less than 1 mm ([0070]: distal portion has a diameter between about 0.5 mm and about 3 mm diameter, so the distal portion may be configured to fit within a blood vessel having a diameter of less than 1 mm, i.e. a 0.5 mm diameter distal portion may be configured to fit within a 0.8 mm diameter blood vessel).
Regarding claim 22, Decre (Figures 1-4C) further discloses wherein the plurality of exposed electrodes (132) comprises at least five exposed electrodes ([0026]).
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.
Claim(s) 2-3 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Decre, as applied to claims 1 and 17 above, and further in view of Young et al., (US 20160144078; hereinafter Young).
Regarding claims 2-3, Decre discloses the endovascular device of claim 1, but fails to disclose wherein the thin film polymer is composed of a thermoplastic polymer, namely Parylene C. However, Young (Figure 4) teaches an endovascular device in which a thin film polymer (301) is composed of a thermoplastic polymer, namely Parylene C ([0048]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Decre to include the thin film polymer being composed of a thermoplastic polymer, namely Parylene C, as taught by Young, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. MPEP 2144.07.
Regarding claim 18, Decre (Figures 1-4C) further discloses wherein the plurality of exposed electrodes (132) are composed of an electrically conductive metal, an electrically conductive metal alloy ([0074]), or an electrically conductive metal oxide, but fails to disclose wherein the thin film polymer is composed of a thermoplastic polymer. However, Young (Figure 4) teaches an endovascular device in which a thin film polymer (301) is composed of a thermoplastic polymer, namely Parylene C ([0048]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Decre to include the thin film polymer being composed of a thermoplastic polymer, namely Parylene C, as taught by Young, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. MPEP 2144.07.
Claim(s) 8 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Decre, as applied to claims 1 and 17 above, and further in view of Karicherla et al., (US 20230158294; hereinafter Karicherla).
Regarding claim 8, Decre discloses the endovascular device of claim 1, but fails to disclose wherein the thin film polymer strip having an electrode array is an angled strip wrapped into two helices with different wrapping angles. However, Karicherla (Figure 7) teaches an endovascular device (700) in which a thin film polymer strip (705) is an angled strip wrapped into two helices (735, 745) with different wrapping angles ([0122]-[0125]: the strip 705 comprises one helix portion 735 with loose helixes and another helix portion 745 with tight helixes, wherein the two portions 735 and 745 have different wrapping angles to form the loose and tight helixes, respectively). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the thin film polymer strip formed by a straight strip wrapped into a helix, as disclosed by Decre, with the thin film polymer strip formed by an angled strip wrapped into two helices with different wrapping angles, as taught by Karicherla, since both thin film polymer strips perform the same function of providing electrodes and corresponding electrical components for sensing/stimulating in a target area, and it has been held that substituting parts of an invention which perform the same function involves only routine skill in the art. MPEP 2144.06 (II)(B).
Regarding claim 20, Decre discloses the method of claim 17, but fails to disclose wherein the thin film polymer strip having an electrode array is an angled strip wrapped into two helices with different wrapping angles. However, Karicherla (Figure 7) teaches an endovascular device (700) in which a thin film polymer strip (705) is an angled strip wrapped into two helices (735, 745) with different wrapping angles ([0122]-[0125]: the strip 705 comprises one helix portion 735 with loose helixes and another helix portion 745 with tight helixes, wherein the two portions 735 and 745 have different wrapping angles to form the loose and tight helixes, respectively). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the thin film polymer strip formed by a straight strip wrapped into a helix, as disclosed by Decre, with the thin film polymer strip formed by an angled strip wrapped into two helices with different wrapping angles, as taught by Karicherla, since both thin film polymer strips perform the same function of providing electrodes and corresponding electrical components for sensing/stimulating in a target area, and it has been held that substituting parts of an invention which perform the same function involves only routine skill in the art. MPEP 2144.06 (II)(B).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Decre, as applied to claim 1 above, and further in view of Mattmüller et al., (US 20230263454; hereinafter Mattmüller).
Regarding claim 9, Decre (Figures 1-4C) further discloses wherein the thin film polymer strip (301) having an electrode array (132) is a strip wrapped around a cylindrical mandrel (302), ([0065]), but fails to disclose that the strip is a sawtooth strip. However, Mattmüller (Figure 1) teaches a device in which an electrode strip is configured as a sawtooth strip ([0126]-[0128]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the straight strip disclosed by Decre with a sawtooth strip, as taught by Mattmüller, since the modification would enable particularly good surface coverage on the target tissue, so that the target tissue can be stimulated particularly well or stimulus responses can be derived therefrom (Mattmüller; [0128]).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Decre, as applied to claim 11 above, and further in view of Liu et al., (US 20200309612; hereinafter Liu).
Regarding claim 12, Decre discloses the endovascular device of claim 11, but fails to disclose wherein the other embedded electrodes or sensor types include a component selected from the group consisting of resistive temperature or strain sensors with no exposed metal areas and interdigitated electrodes with or without exposed metal areas. However, Liu (Figure 2Ai-2Aii) teaches interdigitated electrodes (124a, 124b) with or without exposed metal areas forming a pressure sensor (120), ([0035]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Decre to include a component selected from the group consisting of resistive temperature or strain sensors with no exposed metal areas and interdigitated electrodes with or without exposed metal areas, as taught by Liu, since the modification would enable the measurement of pressure without any external connections, which may provide the advantage of achieving an implantation fully concealed within the cranium or other subcutaneous target area (Liu; [0014]).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Decre, as applied to claim 1 above, and further in view of Kaplan et al., (US 20150202351; hereinafter Kaplan).
Regarding claim 14, Decre (Figures 1-4C) further discloses wherein the device (130) is temporarily attached to the commercial vascular guide wire during implantation and detached after implantation, allowing removal of the commercial vascular guide wire ([0067]-[0069]: stylet/stiffener of the guidewire is temporarily attached to the device during implantation and removed after implantation). Decre fails to disclose that the device is attached to the commercial vascular guide wire using a biodissolvable adhesive; and once implanted, the biodissolvable adhesive is dissolved. However, Kaplan teaches a biodissolvable adhesive for use with a guide wire ([0003]. [0328], [0342]), wherein the biodissolvable adhesive is dissolved after implantation ([0061], [0342]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Decre to include the device attached to the commercial vascular guide wire using a biodissolvable adhesive, wherein once implanted, the biodissolvable adhesive is dissolved, as taught by Decre, because the modification would provide improved biocompatibility ([0328]).
Response to Arguments
Applicant's arguments filed 06/02/2026 have been fully considered but they are not persuasive. In response to Applicant’s first argument that Decre contains no disclosure of discrete insulated micro-wires having a distal wire end electrically connected to the bond pads and a proximal wire end stripped of insulation, as claim 1 requires, Examiner respectfully disagrees. Paragraph [0072] of Decre clearly discloses that cable section 303 may include an individual conducting track 320 (micro-wire) corresponding to each individual electrode 132 and contact 322. The individual conducting tracks may be electrically isolated from each other (providing the insulated micro-wires). Each individual conducting track 320 electrically couples a respective distal electrode to a respective proximal contact 322, wherein the proximal wire end must not have any insulation (which electrically isolates the conducting tracks/insulated micro-wires from each other) in order to connect to recording or stimulation equipment and a distal wire end electrically connected to the bond pads.
In response to Applicant’s second argument that Decre does not disclose a commercial vascular guide wire, Examiner notes that the claims not require a commercial vascular guide wire, but rather that the thin film polymer strip has a helical or cylindrical shape which may be configured to fit around a commercial vascular guide wire. As Applicant points out, Decre describes a deep brain stimulation lead whose distal portion has a diameter "between about 0.5 millimeters (mm) and about 3 mm diameter, e.g., about 1.3 mm" (Decre, [0070]). Therefore, the size and structure of the strip may be configured to fit around a commercial vascular guide wire, which generally has a diameter about 0.254 mm to 0.9652 mm. Therefore, Examiner maintains that Decre discloses the invention as recited in the newly amended claim set.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/C.C.P./Examiner, Art Unit 3794
/EUN HWA KIM/Primary Examiner, Art Unit 3794
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