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 with respect to claim(s) 8 and 10, see Remarks filed 08/20/2025, pg. 5-7, have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. New grounds of rejection are made over Baudino (US 5865843) and Pohndorf (US 4683895). See rejections below.
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.
Claims 8 and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Baudino (US 5865843).
Regarding claim 8, Baudino discloses an electrical lead (Abstract; Fig. 1) comprising: a proximal portion configured to engage a controller, the controller configured to cause one or more electrodes to generate therapeutic energy (Col. 2, ll. 61-65: “As known to persons of ordinary skill in the art, if electrical, the lead may connect to an electrical signal generating device (hereafter "a signal generator") which may or may not be implantable in whole or in part into the human body”); and a distal portion (Fig. 1, distal portion 10) coupled to the proximal portion, the distal portion comprising: one or more electrodes that are configured to generate the therapeutic energy for biological tissue of a patient (electrode 12); and one or more grooves or notches in a proximal part of the distal portion configured to facilitate fixation of the lead to patient tissue (grooves 18; Abstract: “Soft tissue and a fibrotic sheath form about the valley and protuberance of the lead such that the lead is fixed longitudinally and laterally, acutely and chronically, by the anchor”).
Regarding claim 18, Baudino discloses the one or more electrodes are disposed on a distal part of the distal portion and not on the proximal part of the distal portion (Fig. 1, electrode 12 is disposed on distal part of distal portion 10).
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.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Baudino in view of Peterson et al. (US 6078837) (hereinafter Peterson).
Regarding claim 9, Baudino 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, ll. 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 Baudino 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 10 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Baudino in view of Pohndorf (US 4683895).
Regarding claim 10, Baudino discloses a method comprising: inserting an electrical lead (Col. 1, ll. 4-5: “medical… leads of the type used for insertion into the human body”) comprising: a proximal portion configured to engage a controller, the controller configured to cause one or more electrodes to generate therapeutic energy; and a distal portion coupled to the proximal portion, the distal portion comprising: one or more electrodes that are configured to generate the therapeutic energy for biological tissue of a patient; and one or more grooves or notches in a proximal part of the distal portion (see rejection of claim 8 above).
Baudino does not disclose securing the lead to patient tissue by suturing around the lead through the one or more grooves or notches and into the biological tissue.
Pohndorf, however, teaches suture sleeve anchoring device (Abstract) wherein a lead is secured to patient tissue by suturing around a lead through one or more grooves or notches and into biological tissue (Fig. 2, suture sleeve 24 receives sutures at suture grooves 28, 30 for securing lead 16 to patient tissue; Col. 2, ll. 46-56: “Referring now to FIG. 2, there is illustrated therein an enlarged view of the suture sleeve 24 shown in FIG. 1. As shown, the suture sleeve 24 has a lumen 26 through which the pacing lead 16 extends and has two spaced apart suture receiving grooves 28 and 30 which extend circumferentially about the suture sleeve 24. Typically, in conventional use of the suture sleeve 24, sutures (not shown) are tied around and in the suture grooves 28 and 30 and sewn through underlying tissue to secure the sleeve 24 with a pacing lead body therein to the underlying tissue”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of this invention to modify Baudino to include securing the lead to patient tissue by suturing around the lead through the one or more grooves or notches and into the biological tissue. Making this modification would be useful for further facilitating fixation of the lead body to underlying tissue, as taught by Pohndorf.
Regarding claim 19, modified Baudino teaches the one or more electrodes are disposed on a distal part of the distal portion and not on the proximal part of the distal portion such that the method includes not suturing the distal part of the distal portion using the one or more grooves or notches (Fig. 1 of Baudino is being modified to receives sutures at grooves 18 as provided in the rejection of claim 10 above).
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over modified Baudino in view of Sachs et al. (WO 2015/059570) (hereinafter Sachs).
Regarding claims 11-12, modified Baudino does not teach sliding an anchor cap over the distal portion, securing a cap head to the biological tissue utilizing one or more holes or notches in the cap head.
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”), 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 modified Baudino to include sliding an anchor cap over the distal portion, 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
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/A.A.G./Examiner, Art Unit 3792
/William J Levicky/Primary Examiner, Art Unit 3796