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 .
The current application has an effective filing date of 10/27/2023.
Claim Status
As per preliminary claim amendment received on 04/06/2026, claims 1-4,6-14 and 16-22 are pending; all pending claims have been amended, and claims 5 and 15 have been cancelled.
Claim Objections
Claim 21 is objected to because of the following informalities: limitation b) “the crip tube” should be amended to “the crimp tube”. 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 2, 4, 7-9, 14, 17-19 and 21-22 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.
Regarding claims 2, 4, 7-9, 14, 17-19 and 22, the phrase "substantially" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
To claim 21, a) limitation “the tubular ring” lacks proper antecedent basis in the claim. Further “the tubular ring extending along a longitudinal tubular ring axis” is confusing, because the “longitudinal tubular ring axis” appears to be separate from the “tubular ring.”
To claim 21, c) limitation “an electrode” is ambiguous because it is not clear whether this is the same or different electrode than the one mentioned in this claim’s preamble. Also “…thickness extending from an outer electrode surface to an opposed inner electrode surface” is ambiguous because it is unclear which orientation/direction defines ‘inner’ and ‘outer.’
To claim 22, the term “the crimp ring axis” lacks proper antecedent basis in the claim.
Claim Interpretation
Regarding claims 6 and 16, the limitation “wherein the electrode surface is welded to the tubular ring” is a product by process claim limitation, see MPEP 2113 I: product by process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 3-6, 8, 10-11, 13, 16-18, 20 and21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Skubitz et al. US 2022/0016414 A1 (hereinafter “Sku”).
Regarding claim 1, Sku discloses an electrode (each of electrode preforms 102, 104, 106, and 108 is individually sufficient to meet “electrode” in this claim; exemplary as shown in Figs.5A-7) for a medical device (therapy device 10), the medical device (10) including a lead body (medical lead 50) comprising at least one electrical conductor (74A), the electrode comprising:
a) a tubular ring (conductive ring, e.g. 112, 122) formed from a conductive material (inherent, see [0109-0110: first 2 sentences]), wherein a void (“void” defined by the inner perimeter/surface of each conductive rings; alternatively, lumen segment, e.g. 114, 124; [0111, 0114]) is defined within the tubular ring, and wherein the at least one electrical conductor is connected to the tubular ring (see Fig. 5A; conductor 74A connects through each of electrodes 102, 104, 106 and 108 as shown, also see [0108]); and
b) an electrode surface (entire outer surface on such as shown in Fig. 5B: 102 and Fig. 5E: 108; or in electrode sections such as shown in Fig.5C: 136 and Fig. 5D; 156) associated with the tubular ring (102, 104, 106, and 108), wherein the void (inner perimeter or lumen) within the tubular ring is configured to accept overmolded material of the lead body (50) therein to anchor the tubular ring connected to the at least one electrical conductor (74A) within the lead body ([0119] “A preform preassembly, such as preform preassembly 100 of FIG. 5A, may have an overmold applied to the preassembly to form part of the lead body…Preassembly 164 may have an overmold layer 166 forming a surface of preassembly 164 and joining electrode preforms 102, 104, 106, and 108 of FIG. 5A into pre-grind preassembly 164.”), and the electrode surface is configured to contact and stimulate tissue of a patient with the lead body implanted within the patient (see [0071-0076] electrodes preforms on lead 50 are adapted to provide electrical stimulation to an implanted target location)
Regarding claim 3, Sku discloses the electrode of claim 1, wherein the electrode surface is integrally formed with the tubular ring. (Inherent feature because the entire preform acts as an electrode, see [0109: 1st sentence] “Each of electrode preforms 102., 104, 106, and 108 may be formed from a continuous electrically conductive ring. Each conductive ring may be configured for use as one or more electrodes…”)
Regarding claim 6, Sku discloses the electrode of claim [[5]] 1, wherein the electrode surface is welded to the tubular ring. (This is a product by process claim, it is met by the structure of the electrode preform as taught in claim 1 and see [0109: 1st sentence] “Each of electrode preforms 102., 104, 106, and 108 may be formed from a continuous electrically conductive ring. Each conductive ring may be configured for use as one or more electrodes…”)
Regarding claim 7, Sku discloses the electrode of claim 1, wherein the electrode surface has a substantially rectangular shape. (Fig. 5C, the plurality of electrode portions 136 is substantially rectangular, see [0118] “The plurality of electrode portions 136 of segmented electrode preform 106,”)
Regarding claim 8, Sku discloses the electrode of claim 1, wherein the tubular ring includes a longitudinal ring axis extending along a length of the tubular ring, the tubular ring being configured to be disposed within the lead body such that the longitudinal ring axis extends substantially parallel to a longitudinal lead axis. (As shown in Fig. 5A, each electrode preform has longitudinal ring axis that is parallel to the longitudinal lead axis or length of lead body 50)
Regarding claim 10, Sku discloses the electrode of claim 1, further comprising a crimp tube (conductor channels and/or connection channels on each electrode preform 102, 104, 106, 108; e.g. Fig.5B: 116, 118, Fig. 5C:126, 128; see [0110, 0115]) attached to the tubular ring, wherein the crimp tube is configured to receive and electrically couple to the at least one electrical conductor of the lead body. ([0109] “The conductor channels of an electrode preform may be configured to pass through conductors configured for coupling to electrode preforms distal to the electrode preform, while the connection channels may be configured to house a connection portion or connection sleeve of a conductor for coupling to the particular electrode preform.”)
Regarding claim 11, Sku discloses a lead (medical lead 50) for a medical device (therapy system 10), the lead (medical lead 50) comprising:
a) a lead body (medical lead 50) comprising at least one electrical conductor (74A); and
b) an electrode (each of electrode preforms 102, 104, 106, and 108 is individually sufficient to meet “electrode” in this claim; exemplary as shown in Figs.5A-7) disposed within the lead body (50), the electrode including:
i) a tubular ring (conductive ring, e.g. 112, 122) formed from a conductive material (inherent, see [0109-0110: first 2 sentences]) and having a longitudinal ring axis extending along a length of the tubular ring (see Fig. 5A, each electrode preform has a longitudinal ring axis that is parallel to the longitudinal lead axis or length of lead body 50), wherein a void (“void” defined by the inner perimeter/surface of each conductive rings; alternatively, lumen segment, e.g. 114, 124; [0111, 0114]) is defined within the tubular ring, and wherein the at least one electrical conductor is connected to the tubular ring (see Fig. 5A; conductor 74A connects through each of electrodes 102, 104, 106 and 108 as shown, also see [0108]); and
ii) an electrode surface (entire outer surface on preforms 108 and 108, surfaces 136 and 156 on electrode preforms 104 and 106 ) associated with the tubular ring, wherein the void (inner perimeter or lumen) within the tubular ring is configured to accept overmolded material of the lead body therein to anchor the tubular ring connected to the at least one electrical conductor (74A) and associated with the electrode surface within the lead body ([0119] “A preform preassembly, such as preform preassembly 100 of FIG. 5A, may have an overmold applied to the preassembly to form part of the lead body…Preassembly 164 may have an overmold layer 166 forming a surface of preassembly 164 and joining electrode preforms 102, 104, 106, and 108 of FIG. 5A into pre-grind preassembly 164.”), and the electrode surface is configured to contact and stimulate tissue of a patient with the lead implanted within the patient (see [0071-0076] electrodes preforms on lead 50 are adapted to provide electrical stimulation to an implanted target location).
Regarding claim 13, Sku discloses the lead of claim 11, wherein the electrode surface is integrally formed with the tubular ring. (Inherent feature because the entire preform acts as an electrode, see [0109: 1st sentence] “Each of electrode preforms 102., 104, 106, and 108 may be formed from a continuous electrically conductive ring. Each conductive ring may be configured for use as one or more electrodes…”)
Regarding claim 16, Sku discloses the lead of claim 11, wherein the electrode surface is welded to the tubular ring. (This is a product by process claim, it is met by the structure of the electrode preform as taught in claim 1 and see [0109: 1st sentence] “Each of electrode preforms 102., 104, 106, and 108 may be formed from a continuous electrically conductive ring. Each conductive ring may be configured for use as one or more electrodes…”)
Regarding claim 17, Sku discloses the lead of claim 11, wherein the electrode surface ha a substantially rectangular shape. (Fig. 5C, the plurality of electrode portions 136 is substantially rectangular, see [0118] “The plurality of electrode portions 136 of segmented electrode preform 106,”)
Regarding claim 18, Sku discloses the lead of claim 11, wherein the tubular ring is configured to be disposed within the lead body such that the longitudinal ring axis extends substantially parallel to a longitudinal lead axis. (As shown in Fig. 5A, each electrode preform has a longitudinal ring axis that is parallel to the longitudinal lead axis of lead body 50)
Regarding claim 20, Sku discloses the electrode includes a crimp tube (conductor channels and/or connection channels on each electrode preform 102, 104, 106, 108; e.g. Fig.5B: 116, 118, Fig. 5C:126, 128; see [0110, 0115]) attached to the tubular ring, and wherein the crimp tube is configured to receive and electrically couple to the at least one electrical conductor of the lead. ([0109] “The conductor channels of an electrode preform may be configured to pass through conductors configured for coupling to electrode preforms distal to the electrode preform, while the connection channels may be configured to house a connection portion or connection sleeve of a conductor for coupling to the particular electrode preform.”)
Regarding claim 21, Sku discloses an electrode (each of electrode preforms 102, 104, 106, and 108 is individually sufficient to meet “electrode” in this claim; exemplary as shown in Figs.5A-7) for a medical device (therapy device 10), the medical device including a lead (medical lead 50) comprising at least one electrical conductor (74A), the electrode comprising:
a) the tubular ring (conductive ring, e.g. 112, 122) extending along a longitudinal tubular ring axis (see Fig. 5A, each electrode preform has a longitudinal ring axis that is parallel to the longitudinal lead axis or length of lead body 50) and comprising spaced-apart proximal and distal access holes on opposed sides of the longitudinal tubular ring axis(see Fig. 5A, each electrode preform 102, 104, 106, and 108 individually has a plurality of through holes connected from the preform’ s distal and proximal surfaces, e.g. channel, lumens as described in [0111, 0114]);
b) a crimp tube (conductor channels and/or connection channels on each electrode preform 102, 104, 106, 108; e.g. Fig.5B: 116, 118, Fig. 5C:126, 128; see [0110, 0115]) extending along a crimp tube axis from a proximal crimp tube portion to a distal crimp tube portion (this is interpreted as the longitudinal axis of the “crimp tube”, e.g. length of conductor channels and/or connection channels), wherein the at least one electrical conductor (74A) of the lead (50) extends into and is secured to the [crimp] tube (conductor channel), and wherein the crimp tube including the electrical conductor (74A) resides in the tubular ring (conductor ring) with the proximal crimp tube portion secured to the tubular ring at the proximal access hole and with the distal crimp tube portion secured to the tubular ring at the distal access hole (conductor
channels and/or connection channels are through holes, thus inherently secure the electric conductor 74A from distal to proximal side); and
c) an electrode having a thickness extending from an outer electrode surface (outer perimeter of conductor ring, e.g. Fig. 5B: 78 and [0108]) to an opposed inner electrode surface (inner perimeter of conductor ring)
d) wherein the tubular ring (conductive ring) connected to the crimp tube (conductor channels and/or connection channels) secured to the at least one electrical conductor (74A) of the lead is connected, to the inner surface of the electrode to thereby provide electrical continuity from the electrical conductor to the crimp tube connected to the tubular ring connected to the electrode. (see Fig. 5A, [0108])
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.
Claims 2, 4, 12, 14 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Sku as applied to claims 1/11/21 above, and in view of Faltys et al. US 2009/0275997 A1 (hereinafter “Faltys”).
Regarding claim 2, Sku discloses the electrode of claim 1 comprising a tubular ring (conductive rings, see [0005] and rejection to claim 1), but does not disclose wherein the tubular ring has a substantially ellipse shape. Faltys, another prior art reference in the analogous art implanted electrical therapy system, comprising a lead body having thereon ring electrode (taken to encompass “tubular ring”), wherein the ring electrode can have a round, oval or tapered (substantially flat) cross section, as shown in Fig. 10 and [0049]. In here, oval cross-section is taken to encompass “substantially ellipse shape” of the tubular ring. It would have been obvious to a person of ordinary skill in the art at the time of invention to modify Sku’s tubular ring which has a substantially round cross-section (as shown in Figs. 5A-5E) to adapt an oval cross-section in view of Falthys; the motivation for doing so would have been an obvious design choice to adapt a stimulation lead for the same field of endeavor, i.e. implantable lead for vagus nerve stimulation (Sku: [0071], Faltys: [0014, 0045])
Claims 12 and 22 are rejected by Sku in view of Faltys under the same rationale as discussed to claim 2 above.
To claim 22, Sku further discloses wherein the crimp ring axis (this is interpreted as “crimp tube axis”) is aligned substantially perpendicular to and spaced from the longitudinal tubular ring axis. (see Fig. 5A)
Regarding claim 4, Sku discloses the electrode of claim 1, wherein the electrode surface extends either entirely along the outer perimeter of the conductive ring (entire outer surface on such as shown in Fig. 5B: 102 and Fig. 5E: 108), or in sections (electrode sections such as shown in Fig.5C: 136 and Fig. 5D; 156), but does not disclose wherein the electrode surface is a substantially flattened portion of the tubular ring. Faltys, another prior art reference in the analogous art implanted electrical therapy system, comprising a lead body having thereon ring electrode (taken to encompass “tubular ring”), the electrodes typically include one or more electrical contact surfaces which are electrically connected to a connector (e.g., wire, channel, etc.) (see [0048]); wherein the electrodes on the lead may have any appropriate surface geometry and the lead cross-section can be one of a round, oval or tapered (substantially flat) cross section, and wherein the electrode surface can be symmetrical or partial asymmetrical as shown in Fig. 10 and [0049]. In view of the various embodiments taught in Faltys, it would have been obvious to a person of ordinary skill int eh art at the time of invention o modify Sku to modify the electrode surface such that it is substantially flat, the motivation for doing so is such that the flat surface of a lead can wraps around the wall of the vessel. (Faltys: [0023])
Claim 14 is rejected by Sku in view of Faltys under the same rationale as discussed to claim 4 above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHIRLEY X JIAN whose telephone number is (571)270-7374. The examiner can normally be reached M-F 8:00-4:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at 571-270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHIRLEY X JIAN/Primary Examiner, Art Unit 3792
September 14, 2026
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