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 Objections
Claim 1 objected to because of the following informalities:
“each electrode” in line 10 should be written “each electrode of the plurality of exposed electrodes”
“bond pads” in line 12 should be written “the plurality of bond pads”
Appropriate correction is required.
Claim 4 objected to because of the following informalities:
“plurality” in line 1 should be written “the plurality”
Appropriate correction is required.
Claim 10 objected to because of the following informalities:
“the exposed electrodes” in lines 1-2 should be written “the plurality of exposed electrodes”
Appropriate correction is required.
Claim 15 objected to because of the following informalities:
“each proximal end” in line 4 should be written “each proximal wire end”
Appropriate correction is required.
Claim 16 objected to because of the following informalities:
“the proximal end” in line 2 should be written “the proximal wire end”
“each micro-wire” in line 2 should be written “each insulated micro-wire”
Appropriate correction is required.
Claim 17 objected to because of the following informalities:
“each electrode” in line 10 should be written “each electrode of the plurality of exposed electrodes”
“bond pads” in line 12 should be written “the plurality of bond pads”
“stimiluating” in line 16 should be written “stimulating”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation “a plurality of insulated traces connecting each electrode to a single bond pad” in lines 10-11. However, it is unclear whether this limitation is meant to be interpreted as each electrode of the plurality of exposed electrodes being individually connected to a respective one of the plurality of bond pads, or each of the plurality of exposed electrodes being connected to only one of the plurality of bond pads.
Claims 2-12 are rejected as being dependent upon a rejected base claim.
Claim 13 recites the limitation “a commercial guide wire” in line 2. However, it is unclear whether this limitation is meant to be interpreted as the commercial vascular guide wire recited in claim 1, or a different guide wire.
Claim 14 recites the limitations “a commercial guide wire” in line 2 and “the commercial guide wire” in line 5. However, it is unclear whether these limitations are meant to be interpreted as the commercial vascular guide wire recited in claim 1, or a different guide wire.
Claim 15 recites the limitations “external recording or stimulation equipment (transcutaneous use)” in line 2 and “external recording equipment” in line 6. However, it is unclear whether these limitations are meant to be interpreted as the recording or stimulation equipment recited in claim 1, or different equipment.
Claim 16 recites the limitations “implantable electronics” in line 2 and “electronics” in line 3. However, it is unclear whether these limitations are meant to be interpreted as the electronics recited in previous claims, or different electronics.
Claim 17 recites the limitation “a plurality of insulated traces connecting each electrode to a single bond pad” in lines 10-11. However, it is unclear whether this limitation is meant to be interpreted as each electrode of the plurality of exposed electrodes being individually connected to a respective one of the plurality of bond pads, or each of the plurality of exposed electrodes being connected to only one of the plurality of bond pads.
Claims 18-20 are rejected as being dependent upon a rejected base claim.
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, and 19 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) to a single bond pad (322), ([0072]); and insulated micro-wires (conductive tracks) having a distal wire end electrically connected to 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 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 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 a commercial 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 external recording or stimulation equipment (110), the adapter (111) including: a first side (distal side) that includes discrete connections to the proximal end of each insulated micro-wire (conductive tracks); and a second side (proximal side) that connects to external recording equipment (110) via a standard connector (120/220), ([0021], [0075]).
Regarding claim 16, Decre (Figures 1-4C) further discloses wherein: the proximal end of each micro-wire (conductive trace) is connected to implantable electronics (111); and the device (130) and 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) to a single bond pad (322), ([0072]); and insulated micro-wires (conductive traces) having a distal wire end electrically connected to 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].
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 a commercial guide wire during implantation and detached after implantation, allowing removal of the commercial 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 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 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]).
Conclusion
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/C.C.P./Examiner, Art Unit 3794
/EUN HWA KIM/Primary Examiner, Art Unit 3794