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 .
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 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.
(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 1-5, 7-10, 12 and 13 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Yang et al. (2019/0232053).
Regarding Claim 1, Yang discloses implanting a distal end of a lead 18 in the His bundle (par. [0075]), wherein electrode 42 is fixated in and therefore intersects the His bundle as claimed. Yang discloses delivering electrical stimulation to electrodes 40 and 42 (par. [0041, 0075])
In regards to Claim 2, Yang discloses fixating the electrodes to cardiac tissue via a helix 42 (Fig. 2; see also other embodiments described in Fig. 6-8, par. [0076-0086])).
With regards to Claim 3, Yang discloses lead 18 has a linear array of four electrodes 40, 42, 52 (which has an electrode therein) and 62. These electrodes are spaced linearly along the lead 18 (Fig. 2; par. [0040, 0042]).
In regards to Claim 4, the Examiner notes that by placing distal end of leads 18 in the His bundle as contemplated by Yang and by securing the lead with distal helical electrode 42, the lead 18 would project orthogonally from the anchor site and thus the electrodes thereon would be located orthogonally. While Yang does not provide a drawing for this specific embodiment, the orthogonal projection from the anchor area would resemble the orthogonal projection from cardiac tissue illustrated in Fig. 1-3 of Yang.
Regarding Claim 5, Yang discloses electrodes 40, 42, 52 and 62 are on a distal section of lead 18 (Fig. 2).
With regards to Claim 7, Yang discloses a lead 18 having a distal section with a plurality of electrodes 40, 52 and 62 arranged linearly along the lead and wherein lead 18 has a proximal section for connecting to pulse generator 16 (Fig. 1-3).
In regards to Claims 8 and 9, Yang discloses fixation helix 42 (Fig. 1-3).
Regarding Claims 10, 12 and 13, Yang discloses four electrodes 40, 42, 52 and 62, wherein electrode 42 is a penetrating electrode such that it acts as a fixation element.
Claims 14 and 15 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Brockway et al. (2009/0088813).
Regarding Claim 14, Brockway discloses a leadless pacemaker comprising an elongate body 18 having a linear array of electrode 20, 21 and 22 spaced thereon. Brockway also discloses a pulse generator 34, 40 (Fig. 2; par. [0048, 0057]).
In regards to Claim 15, Brockway discloses a fixation element such as a fabric patch to promote tissue ingrowth (par. [0045]).
Claims 7, 10 and 11 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Moffitt et al. (2010/0137960).
Regarding Claims 7, 10 and 11, Moffitt discloses a pacing lead 14 having a linear array of 8 electrodes 28 spaced along the distal end of the lead 14. Moffitt further discloses a proximal end of lead 14 connected to pulse generator 12 (par. [0042]; Fig. 2).
Claims 14-16, 19 and 20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Yang et al. (2019/0290905).
Regarding Claim 14, Yang discloses a leadless pacing device comprising an elongate body 730 having a pulse generator therein (not shown); a plurality of electrodes 712, 722a, 724 arranged linearly along a longitudinal axis 731 of the elongate body 730 (Fig. 5; par. [0086, 0093]).
In regards to Claims 15, 16, 19 and 20, Yang discloses electrode 712 acts as a helical fixation element that is adapted to penetrate cardiac tissue (par. [0086-0087]).
Claims 1 and 6 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Koop et al. (2019/0192864).
Regarding Claims 1, 2, 4 and 6, Koop discloses a method for His bundle pacing comprising affixing a leadless pacemaker 420 (par. [0128]) to the bundle of His thus intersecting the His bundle (par. [0010, 0012, 0132] FIG. 8) via a penetrating electrode 442 and subsequently applying electrical stimuli to the electrode 442 which is part of a linear array of electrodes 440, 442, 444, 446 (Fig. 8; par. [0128, 0133-0134]).
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 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.
Claims 17 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Brockway et al. (2009/0088813).
In regards to Claims 17 and 18, Brockway explicitly discloses the use of three electrodes 20-22 but fails to explicitly disclose the use of four or eight electrodes as claimed. However, Brockway does contemplate the use of more electrodes than shown in the exemplary embodiment (par. [0048]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include four or eight electrodes instead of three, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
Conclusion
This is a Continuation of applicant's earlier Application No. 16/558854. All claims are identical to, patentably indistinct from, or have unity of invention with the invention claimed in the earlier application (that is, restriction (including lack of unity) would not be proper) and could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the earlier application. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action in this case. See MPEP § 706.07(b). 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.
/ALLEN PORTER/ Primary Examiner, Art Unit 3796