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/Restrictions
Claims 21-22, 25-27 and 29 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/16/2025.
Applicant’s election without traverse of 1-9, 11, 16 and 18-19 in the reply filed on 07/16/2025 is acknowledged.
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 1-9, 11, 16 and 18-19 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.
Claims 1 and 2 includes the language “optionally wherein the spine is configured to provide a passage for electrical conductors from an implantable pulse generator to the at least one electrode”. It is unclear if the limitation is required. The metes and bounds of the claim unclear. The examiner suggests either requiring the spine to provide passage for electrical conductors by removing “optionally” or deleting the entire clause.
Claim 4 includes the language “optionally wherein the movement is in a perpendicular direction to the axis of the target” and “optionally wherein the movement results in bending of the neural interface such that there is a curvature in a length of the neural interface parallel to the axis of the target”. It is unclear if these limitations are required. The metes and bounds of the claim unclear. The examiner suggests either requiring the movements in a direction by removing “optionally” or deleting these clauses entirely.
Claim 16 recites the limitations "the second portion" in lines 2 and 3 and "the first portion" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 19 recites the limitations "the second portion" in line 2 and "the first portion" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claims 1, 3, 5-9, 11, and 18 are rejected for being dependent on indefinite claim 1.
Claim Rejections - 35 USC § 102
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.
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) 1-3, 6-9, 11, 13, 16, 18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zaidi et al. (Publication No. WO 2019/020985, hereinafter “Zaidi”) NOTE: for the purposes of examination, the citations to the foreign application will be cited from the US publication US 2020/0230399 which contain paragraph numbers.
Regarding claim 1, Zaidi discloses an implantable neural interface system, comprising:
at least one electrode (Fig. 8B (812) (814));
a spine (Fig. 8A (808)), optionally wherein the spine is configured to provide a passage for electrical conductors (Figs. 8A, 8B (818)) from an implantable pulse generator to the at least one electrode (pars. [0009], [0013]: spinal portion configured to house electrical conductors for the first electrode and the second electrode, [0036]: Connecting individual electrodes or different arrays of electrodes to different conductors may enable selective stimulation of the target vessel by individually controlling each connected device; indicates that the electrodes are connected to an implantable generator device by the electrical conductors);
at least one arm extending from the spine (Figs. 8A, 8B and par. [0052]: The interface 800 includes a flexible structure similar to that of FIG. 4B…The neural interface 800 is similar to the neural interface 400 in FIG. 4B…The neural interface 800 may include two arms at either end of the device, such as end portions 804 and 806 ), wherein the electrode is positioned on the arm (par. [0052]: The end portions 804 and 806 may each be in a C-ring configuration and contain electrode arrays, such as arrays 812 and 814); and
a strain relief feature configured to reduce strain in relative movement of one or more of the spine and the at least one arm to accommodate a curvature in an axis of a target on or in which the spine and at least one arm are provided (see Fig. 8A; strain relief feature proximal the curved arms 804).
Regarding claim 2, Zaidi discloses an implantable neural interface system, comprising:
at least one electrode (Fig. 8B (812) (814));
a spine (Fig. 8A (808)), optionally wherein the spine is configured to provide a passage for electrical conductors from an implantable pulse generator to the at least one electrode;
at least one arm extending from the spine (Figs. 8A, 8B and par. [0052]: The interface 800 includes a flexible structure similar to that of FIG. 4B…The neural interface 800 is similar to the neural interface 400 in FIG. 4B…The neural interface 800 may include two arms at either end of the device, such as end portions 804 and 806 ), wherein the electrode is positioned on the arm (par. [0052]: The end portions 804 and 806 may each be in a C-ring configuration and contain electrode arrays, such as arrays 812 and 814); and
a strain relief feature configured to reduce strain in relative movement or displacement of portions of neural interface system to accommodate a curvature in an axis of a target on or in which the neural interface is provided (see Fig. 8A; strain relief feature proximal the curved arms 804).
Regarding claim 3, Zaidi discloses a neural interface system of claim 1, wherein the strain relief feature comprises at least one of: a notch, a joint, a ball joint, a portion comprising higher flexibility material than its surrounding portion, and a reduced cross-sectional area (see Fig. 8A; a strain relief feature comprising notches and a reduced cross-sectional area is located on the spine proximal the curved arms 804).
Regarding claim 6, Zaidi discloses the neural interface system of claim 1 comprising a plurality of arms, wherein the spine comprises the strain relief feature positioned between the curved arms and a portion of the spine proximal to the curved arms, and each of the strain relief features partially or fully surround a circumference of the spine (see Fig. 8A; strain relief notch features fully surround the circumference contains reduced cross section).
Regarding claim 7, Zaidi discloses the neural interface system of claim 1, further comprising a silicone tubing surrounding the electrical conductors positioned inside the spine (Figs. 8A and 8B and par. [0053]: Before the conductors 818 and 819 exit the material of the spinal portion they are also covered with a silicon lead body tubing 820 to form the lead body conductor 822).
Regarding claim 8, Zaidi discloses the neural interface system of claim 1, comprising an extended spine portion between the spine portion from which the arms extend and a lead body comprising a part of the conductor between the spine and an implantable pulse generator, wherein the strain relief feature is provided in the extended spine portion (see Figs. 8A and 8B; strain relief feature located in the spine 808 in the portion extended from arm extension end 804 to the lead body 822 comprising part of the conductor).
Regarding claim 9, Zaidi discloses the neural interface system of claim 1, wherein at least two curved arms (Figs. 8A and 8B (804) (806) and par. [0052]: The end portions 804 and 806 may each be in a C-ring configuration and contain electrode arrays, such as arrays 812 and 814 of FIG. 8B) at least partially extend radially from a first portion the spine (Fig. 8A; spine portion containing substrate 802 is the first portion), and wherein the spine comprises the strain relief feature positioned on the first portion, between the curved arms and on a second portion of the spine adjacent to the first portion and proximal to the curved arms (Figs. 8A and 8B; the second portion of spine consists of strain relief features proximal curved arms 804 and 806).
Regarding claim 11, Zaidi discloses the neural interface system of claim 1, further comprising a tubing surrounding the conductors and positioned inside the spine (par. [0053]: Before the conductors 818 and 819 exit the material of the spinal portion they are also covered with a silicon lead body tubing 820 to form the lead body conductor 822..
Regarding claim 13, Zaidi discloses the neural interface system of claim 1, wherein the spine is hollow (Figs. 8A and 8B (808)(818) (819) and par. [0053]: conductors 818 and 819 exit the material of the spinal portion; the spine is hollow to fit the helical conductors).
Regarding claim 16, Zaidi discloses the neural interface system of claim 1, wherein the strain relief feature on the second portion of the spine fully surround the circumference of the spine (Fig. 8A; second portion of spine 808 consists of spine portion proximal the substrate 802 which contains strain relief features that fully surround the circumference of the spine) and increase flexibility between the first portion (Fig. 8A; first portion consists of substrate 802) and the second portion (Figs. 8A and 8B; the second portion consists of strain relief features proximal substrate 802 and provide flexibility between first portion of spine 802 and proximalmost second portion of spine closest to lead body 822).
Regarding claim 18, Zaidi discloses the neural interface system of claim 1, wherein the strain relief feature comprises a cutout that fully surrounds the circumference of the spine (see Fig. 8A; strain relief feature located on spine 808 proximal the neural interface c-ring arm 804 consists of a cutout that surrounds the circumference).
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) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zaidi et al. (Publication No. WO 2019/020985, hereinafter “Zaidi”) in view of Jackson et al. (US 2014/0228923 A1, hereinafter "Jackson", cited by applicant).
Regarding claim 4, Zaidi discloses a neural interface system of claim 1, with a strain relief feature. Zaidi does not disclose wherein the strain relief feature: increases flexibility for relative movement of portions of the neural interface system; and/or
enables relative movement of portions of the neural interface system, optionally wherein the movement is in a perpendicular direction to the axis of the target, optionally wherein the movement results in bending of the neural interface such that there is a curvature in a length of the neural interface parallel to the axis of the target.
However, Jackson in the same field of endeavor: cuff electrode with integrated tendril discloses wherein the strain relief feature: increases flexibility for relative movement of portions of the neural interface system; and/or
enables relative movement of portions of the neural interface system, optionally wherein the movement is in a perpendicular direction to the axis of the target, optionally wherein the movement results in bending of the neural interface such that there is a curvature in a length of the neural interface parallel to the axis of the target (Figs. 2-3 (20)(36)(38)(40) and par. [0042]: the electrode cuffs 20 include a strain relief 36… the strain relief 36 is secured to the lead body 30 in order to help mitigate movement of the first and second electrode cuffs 38, 40) to provide the benefit of mitigating movement of the electrode cuffs (par. [0042]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, to include in the implantable neural interface with strain relief features of Zaidi, a strain relief feature that provides movement in a length of the neural interface parallel to the target axis in order to mitigate movement of the electrode cuffs.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ADREANNE A ARNOLD whose telephone number is (571)272-6794. The examiner can normally be reached M-Th 7:30 a.m - 5:30 p.m..
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/AAA/Examiner, Art Unit 3796
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792