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 .
Response to Arguments
Applicant’s arguments filed 5/4/2026 with respect to the rejection of Independent Claim 1 under 35 U.S.C. 102(a)(1) as being anticipated by US 11253699 B1 to Williams et al. (“Williams”) have been fully considered and are persuasive. The Examiner agrees that Williams does not disclose “wherein the blade section does not extend beyond a distal end of the helix element” as required by amended Claim 1. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of WO 2007/073435 A1.
Applicant’s arguments regarding Dependent Claims 2-15 are based on Applicant’s arguments regarding Independent Claim 1. Applicant’s arguments have been fully considered and are persuasive for the same reasons as explained above with respect to Claim 1. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of WO 2007/073435 A1.
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 1-14 are rejected under 35 U.S.C. 103 as being unpatentable over previously cited US 11253699 B1 to Williams et al. (“Williams”) in view of WO 2007/073435 A1 to Friedman et al. (“Friedman”).
Regarding Independent Claim 1, Williams teaches:
An implantable medical device for implantation into a patient, comprising: (Title, “Cardiac pacing lead;” Col. 2, Ln. 17, “The lead may be implanted via a catheter;” Fig. 4, “Medical Electrical Lead 30”);
- a body having a distal end; (Claim 24, “A medical lead comprising: a lead body; … a helix extending from a distal end of the lead body…;” Fig. 4, “Lead Body 38;” see Annotated Fig. 4, below);
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- an electrode device for at least one of emitting an electrical stimulation signal and sensing an electrical sense signal, said electrode device being arranged at said distal end of the body and comprising a helix element to be screwed into tissue; (Fig. 4, “Helical Anode 32;” Col. 6, Ln. 28-31, “…anode electrode 32 and cathode electrode 34 are electrically isolated within medical lead 30 such that such that anode electrode 32 and cathode electrode 34 may form an electrode pair to deliver stimulation;” Col. 6, Ln. 46-50, “The lead 30 is extended distally from distal tip 24 and anchored into the septum 3 by clockwise rotation of the lead body 38 targeting the LBB, so that helical anode electrode 32 screws through the endocardial membrane and into the septal wall;” Claim 24, “A medical lead comprising: a lead body; … a helix extending from a distal end of the lead body, wherein the helix is configured to anchor to a patient tissue…; Claim 28, “wherein the lead body electrode is a helical electrode formed by the helix.”);
and - a blade section configured to cut into tissue when said helix element is screwed into tissue. (Claim 24, “ and a dissection tip at a distal end of the cable, … wherein, when the helix is anchored to the patient tissue, the dissection tip is configured to penetrate the patient tissue…;” Fig. 4, “cathode 34;” Col. 5, Ln. 46-56; Col. 3, Ln. 56-57);
Williams’s “cathode 34” in Williams’s Fig. 4 is the “dissection tip” described at Williams’s Claim 24. See, e.g., Williams at Col. 5, Ln. 46-56 elaborating upon “cathode 34” as used for dissection.
Although Williams Col. 5, Ln. 46-56 describes “blunt dissection,” Williams additionally contemplates such dissection using “sharp electrodes” at Col. 3, Ln. 56-57.
Williams’s “cathode 34” in the contemplated embodiment wherein “sharp electrodes” are used for Williams’s “dissection tip” are such a “blade section configured to cut into tissue when said helix element is screwed into tissue” as claimed.
Williams does not disclose:
wherein the blade section does not extend beyond a distal end of the helix element.
Friedman describes “Helical electrodes for intramyocardial pacing and sensing” (Title). Friedman is analogous art.
Friedman teaches:
wherein the blade section does not extend beyond a distal end of the helix element (Pg. 4, Ln. 23 through Pg. 5, Ln. 9, “With reference to Figures 1, 2 and 3, the electrical lead 1 described herein has at least an inner electrode 36 and an outer electrode 38. In some embodiments, the inner and outer electrodes can be coaxial at their proximal ends. … Figure 2 shows another embodiment of an electrical lead 1 having an inner electrode 36 and an outer electrode 38. In Figure 2, the outer electrode 38 has a helical shape while the inner electrode 36 is linear. In the embodiment shown in Figure 2, the inner linear electrode 36 is shorter than the outer helical electrode 38;” Figure 2, “inner linear electrode 36” is shown as shorter than “outer helical electrode 38”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Williams with the teachings of Friedman (i.e., to modify the “Helical Anode 32” and “Cathode 34” arrangement of Williams’s Fig. 4 such that “Cathode 34” does not extend beyond a distal end of the helix element “Helical Anode 34” and in the manner of Williams’s “inner linear electrode 36” and “outer helical electrode 38” as shown in Williams’s Figure 2) in order to reduce electrode size, thereby requiring less energy to provide stimulation and extending battery life (Friedman at Pg. 7, Ln. 26-29).
To be clear, the proposed modification entails making William’s “Cathode 34” “shorter than the outer helical electrode” in the manner of Friedman, which “outer helical electrode” corresponds to Williams’s “Helical Anode 32.”
Regarding Claim 2, the combination of Williams and Friedman renders obvious the entirety of Claim 1 as explained above.
Williams additionally discloses:
wherein said helix element comprises a first end and a second end, wherein said helix element is connected to the body at the second end (Fig. 4, “Helical Anode 32” is shown having two ends, one of which is connected to “lead body 38”).
Regarding Claim 3, the combination of Williams and Friedman renders obvious the entirety of Claim 1 as explained above.
Williams additionally discloses:
wherein said blade section is arranged in the vicinity of the second end (Col. 2, Ln. 34-36, “…the cable conductor being slideable within the lead body to extend and retract the electrode relative to the distal end of the lead body;” Col. 5, Ln. 42-45, “Central cable conductor 33 is slideable the central lumen of lead body 38 to extend and retract cathode electrode 34 relative to the distal end of lead body 38.”);
Williams’s “cathode electrode 34,” which – as explained above – includes a “dissection tip,” is retractable from the extended position depicted in Fig. 4. In such a retracted position, Williams’s “cathode electrode 34” is “arranged in the vicinity of the second end” of William’s helical electrode.
Regarding Claim 4, the combination of Williams and Friedman renders obvious the entirety of Claim 1 as explained above.
Williams additionally discloses:
wherein said helix element protrudes from the distal end of the body along a longitudinal axis, said helix element being helically wound about the longitudinal axis (Fig. 4; see Claim 4 Annotated Fig. 4, below)
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Regarding Claim 5, the combination of Williams and Friedman renders obvious the entirety of Claim 4 as explained above.
Williams additionally discloses:
wherein the blade section is formed to extend in between a portion of the helix element and the distal end of the body (Fig. 4, Williams’s “cathode electrode 34,” which – as explained above – includes a “dissection tip” is positioned inside Williams’s helix element, and is thus formed to extend in between a portion of the helix element and the distal end of the body as claimed).
Regarding Claim 6, the combination of Williams and Friedman renders obvious the entirety of Claim 6 as explained above.
Williams additionally discloses:
wherein said portion of the helix element and the distal end define an angular space therebetween, the blade section being arranged in said angular space (Fig. 4, Williams’s “cathode electrode 34,” which – as explained above – includes a “dissection tip” is positioned inside Williams’s helix element, and is positioned in an angular space defined therebetween; Fig. 5C shows this most clearly: see Annotated Fig. 5C, below)
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Regarding Claim 7, the combination of Williams and Friedman renders obvious the entirety of Claim 6 as explained above.
Williams additionally discloses:
wherein the blade section is integrally formed with the body or the helix element (Col. 5, Ln. 46-48, “In the same or different examples, cathode electrode 34 may be a unitary component with the conductive element(s) of cable conductor 33…”).
Regarding Claim 8, the combination of Williams and Friedman renders obvious the entirety of Claim 1 as explained above.
Williams additionally discloses:
wherein the blade section comprises a blade edge which is sharpened to cut into tissue (Fig. 4, “cathode 34;” Col. 5, Ln. 46-56; Col. 3, Ln. 56-57).
Williams “sharp electrodes” described at Col. 3, Ln. 56-57 are such a sharpened blade edge as claimed.
Regarding Claim 9, the combination of Williams and Friedman renders obvious the entirety of Claim 8 as explained above.
Williams additionally discloses:
wherein the blade edge extends longitudinally along a longitudinal direction along which the helix element protrudes from the distal end of the body (Fig. 4, Williams’s blade edge and helix element extend in the same direction, and that direction is the same direction from which Williams’s helix element protrudes from Williams’s distal end of the lead body).
Regarding Claim 10, the combination of Williams and Friedman renders obvious the entirety of Claim 1 as explained above.
Williams additionally discloses:
wherein the electrode device comprises a pin element configured to engage with tissue, the helix element being connected to the pin element (Col. 10, Ln. 26-28, “In the same or different examples, cable conductor 33 may be an insulated cable conductor including outer insulating layer, leaving the distal tip exposed for cathode electrode 34.”)
The base of Williams’s “cathode electrode” is such a “pin element” as claimed.
The Present Specification states “[t]he pin element may for example be formed from an electrically conductive inner core of the body of the implantable medical device, the inner core forming an inner conductor of the body (which in this case for example may be a lead connected to a generator of the implantable medical device).” (See Present Specification at Pg. 7, Ln. 27-30).
Williams’s “cathode electrode” is “formed from an electrically conductive inner core of the body of the implantable medical device” (see Williams at Col. 10, Ln. 26-28), and is thus such a “pin element” as claimed.
Williams’s “helix element” is “connected to” Williams’s “pin element” in an electrical connection via their anode/cathode relationship.
Regarding Claim 11, the combination of Williams and Friedman renders obvious the entirety of Claim 10 as explained above.
Williams additionally discloses:
wherein at least a portion of the helix element is wound about the pin element (Fig. 4, Williams’s “helical anode” is wound about the base of Williams’s “cathode 34”);
and is connected to the pin element along a connection seam (Col. 5, Ln. 46-51, “In the same or different examples, cathode electrode 34 may be a unitary component with the conductive element(s) of cable conductor 33, or may be a separate component physically and electrically coupled to the distal end of the conductive element(s) of cable conductor 33, for example, by solder or welding, such as laser welding;” Col. 6, Ln. 27-31 “For example, anode electrode 32 and cathode electrode 34 are electrically isolated within medical lead 30 such that such that anode electrode 32 and cathode electrode 34 may form an electrode pair to deliver stimulation.”).
Williams’s “welding” as a means of electrical connection is such a “connection seam” as claimed. See Present Specification at Pg. 16, Ln. 24-25 in support of this interpretation.
Williams’s “helical anode” is wound about the base of
Williams’s “cathode 34” forms an anode/cathode relationship with Williams’s “helical anode 32,” thereby rendering the two electrically connected. This electrical connection is caused in part by Williams’s weld. Williams’s “cathode 34” and “helical anode 32” are thus connected along a connection seam as claimed.
Regarding Claim 12, the combination of Williams and Friedman renders obvious the entirety of Claim 11 as explained above.
Williams additionally discloses:
wherein the blade section is formed on the connection seam (Col. 5, Ln. 46-51, “In the same or different examples, cathode electrode 34 may be a unitary component with the conductive element(s) of cable conductor 33, or may be a separate component physically and electrically coupled to the distal end of the conductive element(s) of cable conductor 33, for example, by solder or welding, such as laser welding.”)
Williams’s “cathode electrode 34” is “physically and electrically coupled to the distal end of the conductive element(s) of cable conductor 33” via “solder or welding, such as laser welding.” As explained above at Claim 1, Williams’s “cathode electrode 34” is such a “blade section” as claimed. Williams’s “cathode electrode 34” is formed “on” Williams’s “connection seam” (i.e., the weld) in that Williams’s “connection seam” physically couples it to the lead body.
This interpretation would merit reconsideration were the configuration of Pg. 7, Ln. 17-19 of the Present Specification were more narrowly reflected.
Regarding Claim 13, the combination of Williams and Friedman renders obvious the entirety of Claim 1as explained above.
Williams additionally discloses:
wherein said body, at the distal end, is configured to penetrate into tissue upon cutting into the tissue with said blade section (Col. 6, Ln. 46-54, “The lead 30 is extended distally from distal tip 24 and anchored into the septum 3 by clockwise rotation of the lead body 38 targeting the LBB, so that helical anode electrode 32 screws through the endocardial membrane and into the septal wall. The cathode electrode 34 is extended into the septum 3 to provide pacing to the heart 1 via the LBB. In some examples, cathode cable conductor 33 and cathode electrode 34 may extend through the hole in the endocardial membrane created by helical anode electrode 32.”)
Regarding Claim 14, the combination of Williams and Friedman renders obvious the entirety of Claim 1 as explained above.
Williams additionally discloses:
wherein the body is formed by a lead which is connectable to a generator of the implantable medical device (Col. 9, Ln. 21-26, “In examples in which the pulse generator is an implantable pacemaker, the clinician then inserts the implantable pacemaker in a pocket under the skin in the patient's chest and is ready for sensing and/or pacing via the lead 30.”).
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 15 is rejected under 35 U.S.C. 103 as being unpatentable over previously cited US 11253699 B1 to Williams et al. (“Williams”) in view of WO 2007/073435 A1 to Friedman et al. (“Friedman”) as applied to Claim 1 above, and further in view of previously cited US 20200069938 A1 to Sinnott et al. (“Sinnot”).
Regarding Claim 15, the combination of Williams and Friedman renders obvious the entirety of Claim 1 as explained above.
The combination of Williams and Friedman does not disclose:
wherein the body is formed by a housing of a leadless pacemaker device
It is noted, however, that Williams broadly describes use of Williams’s system “in conjunction with a leadless pacemaker” at Col. 11, Ln. 4-7.
Sinnot describes “…SYSTEMS, DEVICES, AND METHODS FOR HIS BUNDLE CARDIAC PACING” (Title). Sinnot is analogous art.
Sinnot teaches:
wherein the body is formed by a housing of a leadless pacemaker device (Para. [0095], “FIG. 9A depicts an exemplary linear leadless pacemaker having active tine fixation and a helix fixation mechanism;” Para. [0096], “FIG. 9B displays a side view of the exemplary linear leadless pacemaker having active tine fixation and a helix fixation mechanism;” Fig. 9A-9C).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Williams and Friedman with the teachings of Sinnot (i.e., to use the device of combined Williams and Friedman in conjunction with a leadless pacemaker, whereby the body is formed by a housing of the leadless pacemaker device in the manner of Sinnot) in order to provide stabilization to the leadless pacemaker (Sinnot at Para. [0096]).
Conclusion
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 CHRISTOPHER J MUTCHLER whose telephone number is (571)272-8012. The examiner can normally be reached M-F 7:00 am - 4:00 pm.
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/C.J.M./Examiner, Art Unit 3796
/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796
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