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
The Applicant filed Amendments to the Claims and Remarks on March 25, 2026 in response to the Examiner’s Non-Final Office Action and Examiner-Initiated Interview Summary, mailed December 29, 2025.
Amendments to the Claims
At this time, claims 8-12 and 18-19 are pending. Claim 8 has been amended. Claims 8 and 10 are in independent form. The Applicant asserts that no new matter is added. (Remarks, pg. 4)
Claim Rejections - 35 U.S.C. § 102 and 35 U.S.C. § 103
Claims 8 and 18 were previously rejected under 35 U.S.C. 102(a)(1) as being anticipated by Baudino (previously cited).
Claim 9 was previously rejected under 35 U.S.C. 103 over Baudino in view of Peterson (previously cited).
Claims 10 and 19 were previously rejected under 35 U.S.C. 103 over Baudino in view of Pohndorf (previously cited).
Claims 11-12 were previously rejected under 35 U.S.C. 103 over modified Baudino in view of Sachs (previously cited).
In the interview held December 10, 2025 interview, the Examiners agreed that the proposed amendment to independent claim 8 of “one or more grooves or notches in a proximal part of the distal portion configured to receive sutures to facilitate fixation of the lead to patient tissue and prevent further egress or ingress”, now added to the present version of the Claims, would overcome Baudino; however, the Examiners also noted that the prior art (e.g. Pohndorf) would render the instant amendments obvious. (Remarks, pg. 5)
The Applicant has disagreed with the Examiner’s previously presented claim rejections for at least the following reasons:
Pohndorf's longitudinal fixation method removes the benefit of Baudino's screw-in lead (Remarks, pg. 5); and
Pohndorf teaches away from suturing methods (Remarks, pg. 5-6).
Applicant’s arguments with respect to the rejections of claims 8-12 and 18-19 under 35 U.S.C. 102 and 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of (US 2015/0112414, hereinafter to as Conger).
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)(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.
Claims 8, 10, and 18-19 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Conger (US 2015/0112414, hereinafter to as Conger).
Regarding amended, independent claim 8, Conger teaches medical device leads having one or more integrated pressure-resisting members, such as suture-anchoring members ([0001]). Conger further teaches an electrical lead (lead 50 in Fig. 2; leads 20, 24, 30 in Fig. 1) comprising:
a proximal portion (proximal end 58 in Fig. 2) configured to engage a controller ([0055]: “…the electrical components of the IMD 10.” via lead connector(s) 44, 56 in Fig. 1, 2; [0056]: “A lead connector 56 is located at a proximal end 58 of the lead 50 and is configured to be received and retained within a lead receptacle of a header of a medical device, such as shown in FIG. 1.”), the controller configured to cause one or more electrodes to generate therapeutic energy ([0055]: “The IMD 10 may include a housing or can 40 that houses the electrical components of the IMD 10. The IMD 10 may also include a header 42 secured to the can 40. The header 42 is configured to receive lead connectors 44 of the leads 20, 24, and 30.”); and
a distal portion ([0061]: “…a distal end of the lead 50 …”) coupled to the proximal portion, the distal portion comprising:
one or more electrodes (electrodes 22-38 in Fig. 1) that are configured to generate the therapeutic energy for biological tissue of a patient ([0052]: “…deliver left ventricular pacing therapy using at least one left ventricular tip electrode 26 for unipolar configurations or in combination with left ventricular ring electrode 25 for bipolar configurations; deliver left atrial pacing therapy using at least one left atrial ring electrode 27 as well as shocking therapy using at least one left atrial coil electrode 28.”; [0050]; [0053]); and
one or more grooves or notches (grooves 72 in Fig. 3A; [0062]: “…suture-anchoring member 70 includes features that are configured to retain a portion of a suture 71 … a series of grooves 72 …”) in a proximal part of the distal portion ([0061]: “The suture-anchoring member 70 may be closer to the lead connector 56 than to a distal end of the lead 50 that is configured to be inserted into patient vasculature.”) configured to facilitate fixation of the lead to patient tissue ([0061]: “The grooves 72 are configured to receive portions of the suture material, which is wound around the suture-anchoring member 70 to anchor the lead to patient tissue.”) and prevent further egress or ingress ([0057]: “…the suture-anchoring members 46 may provide features on exterior surfaces of the leads 20, 24, and 30 for suture material to nest and positively engage and immobilize or anchor the lead with respect to patient anatomy.” It is noted that grooves 72 of Congo are structurally equivalent to the claimed/disclosed grooves, shown as 5520 in applicant’s Fig. 55, and therefore are inherently capable of providing the claimed function/effect).
Regarding amended, independent claim 10, Conger discloses a method comprising:
inserting an electrical lead (lead 50 in Fig. 2; leads 20, 24, 30 in Fig. 1) comprising:
a proximal portion (proximal end 58 in Fig. 2) configured to engage a controller ([0055]: “…the electrical components of the IMD 10.” via lead connector(s) 44, 56 in Fig. 1, 2; [0056]: “A lead connector 56 is located at a proximal end 58 of the lead 50 and is configured to be received and retained within a lead receptacle of a header of a medical device, such as shown in FIG. 1.”), the controller configured to cause one or more electrodes to generate therapeutic energy ([0055]: “The IMD 10 may include a housing or can 40 that houses the electrical components of the IMD 10. The IMD 10 may also include a header 42 secured to the can 40. The header 42 is configured to receive lead connectors 44 of the leads 20, 24, and 30.”); and
a distal portion ([0061]: “…a distal end of the lead 50 …”) coupled to the proximal portion, the distal portion comprising:
one or more electrodes (electrodes 22-38 in Fig. 1) that are configured to generate the therapeutic energy for biological tissue of a patient ([0052]: “…deliver left ventricular pacing therapy using at least one left ventricular tip electrode 26 for unipolar configurations or in combination with left ventricular ring electrode 25 for bipolar configurations; deliver left atrial pacing therapy using at least one left atrial ring electrode 27 as well as shocking therapy using at least one left atrial coil electrode 28.”; [0050]; [0053]); and
one or more grooves or notches (grooves 72 in Fig. 3A; [0062]: “…suture-anchoring member 70 includes features that are configured to retain a portion of a suture 71 … a series of grooves 72 …”) in a proximal part of the distal portion ([0061]: “The suture-anchoring member 70 may be closer to the lead connector 56 than to a distal end of the lead 50 that is configured to be inserted into patient vasculature.”); and
securing the lead to patient tissue to prevent further egress or ingress ([0057]: “…the suture-anchoring members 46 may provide features on exterior surfaces of the leads 20, 24, and 30 for suture material to nest and positively engage and immobilize or anchor the lead with respect to patient anatomy.”) by suturing around the lead through the one or more grooves or notches and into the biological tissue ([0061]: “The grooves 72 are configured to receive portions of the suture material, which is wound around the suture-anchoring member 70 to anchor the lead to patient tissue.”).
Regarding claim 18, Conger discloses that the one or more electrodes (electrodes 22-38 in Fig. 1) are disposed on a distal part of the distal portion and not on the proximal part of the distal portion (Fig. 1, electrodes 22-38 are disposed on distal part of leads 20, 24, and 30).
Regarding claim 19, Conger discloses that the one or more electrodes (electrodes 22-38 in Fig. 1) are disposed on a distal part of the distal portion and not on the proximal part of the distal portion (Fig. 1, electrodes 22-38 are disposed on distal part of leads 20, 24, and 30) such that the method includes not suturing the distal part of the distal portion using the one or more grooves or notches ([0057]: “…the suture-anchoring members 46 may provide features on exterior surfaces of the leads 20, 24, and 30 for suture material to nest and positively engage and immobilize or anchor the lead with respect to patient anatomy.”; [0061]: “The grooves 72 are configured to receive portions of the suture material, which is wound around the suture-anchoring member 70 to anchor the lead to patient tissue.”).
Claim Rejections - 35 USC § 103
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 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 9 is rejected under 35 U.S.C. 103 as being unpatentable over the Conger in view of Peterson et al. (US 6,078,837, hereinafter referred to as Peterson).
Regarding claim 9, Conger does not disclose suture holes located in the proximal part of the distal portion.
Peterson, however, teaches methods and apparatus for treatment of defibrillation (Abstract) wherein an electrode lead comprises suture holes at a proximal part of a distal portion of the lead (Figs. 4-5, suture holes 88/122). Peterson further teaches that the suture holes facilitate suturing against heart tissue by means of sutures passed through suture holes ([col. 5, li. 10-13]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of this invention to modify Conger to include suture holes located in the proximal part of the distal portion. Making this modification would be useful for further facilitating suturing against tissue by means of sutures passed through suture holes, as taught by Peterson.
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Conger combination in view of Sachs et al. (WO 2015/059570hereinafter Sachs).
Regarding claim 11, Conger does not teach sliding an anchor cap over the distal portion.
Sachs, however, teaches a method for fixing a lead to tissue (Fig. 7D) comprising sliding an anchor cap over the distal portion of a lead (Fig. 7D, suture sleeve 700 is considered anchor cap; para. 116: “suture sleeve 700 is placed over the proximal end of electrode lead 200 and moved distally”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of this invention to modify modified Conger to include sliding an anchor cap over the distal portion. Making this modification would be useful for further facilitation of fixation of a lead to biological tissue, as taught by Sachs.
Regarding claim 12, in view of the Conger/Sachs combination, Conger does not teach securing a cap head to the biological tissue utilizing one or more holes or notches in the cap head.
Sachs, however, teaches securing a cap head to the biological tissue utilizing one or more holes or notches in the cap head (Fig. 7A, middle-end sections 708-712 considered cap head and comprises suture groove 714, which is also considered a hole or notch).
It would have been obvious to one of ordinary skill in the art before the effective filing date of this invention to modify Conger to include securing a cap head to the biological tissue utilizing one or more holes or notches in the cap head. Making this modification would be useful for further facilitation of fixation of a lead to biological tissue, as taught by Sachs.
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 MARY G SCHLUETER whose telephone number is (703)756-4601. The examiner can normally be reached M-F 9:00am-5:30pm EST.
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/M.G.S./Examiner, Art Unit 3796
/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796
