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 .
Priority
This application is a division of US Application no. 17/548,201, now US Patent no. 12,172,004, filed 10 December 2021, which is a continuation of US Application no. 16/171,607, now US Patent no. 11,219,760, filed 26 October 2018, which is a continuation of US Application no. 15/416,282, now US Patent no. 10,159,834, filed 26 January 2017, which claims the benefit of domestic priority to US Provisional Application no. 62/286,967, filed 26 January 2016.
Information Disclosure Statement
The information disclosure statement filed 19 November 2024 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because the submission is missing the a certification statement containing the signature of Applicant’s representative and omits signature blocks for the Examiner signature. It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
Response to Amendment
The preliminary amendment filed 20 November 2024 has been acknowledged. Claims 15-34 are pending, wherein claims 15-34 are new.
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 21 and 23-34 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. Claims 21, 23, and 30 recite that “at least a portion of the leadlet body is rotated in a counterclockwise direction configured to implant of the second end of the leadlet to a second location when the torqued state.” In addition to the grammatical informalities, it is unclear is the counterclockwise rotation places the leadlet body into the torqued state before implantation, or the leadlet is already in a torqued state and is then counterclockwise rotated during implantation, or if the counterclockwise orientation itself defines the torqued state. Clarification is respectfully requested.
Claim 31 recites the limitation "the leadlet mover" in line 3. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 15, 16, and 18-20 is/are rejected under 35 U.S.C. 103 as being obvious over Bonner et al. (US Publication no. 2017/0028194) in view of Eggen et al. (US Publication no. 2013/0310723).
The applied reference to Bonner et al. has a common inventor and applicant with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
In regard to claim 15, Bonner et al. disclose a leadlet pacing device (LPD) 10 (para 17)comprising:
a housing 14 extending from a proximal end 44 to a distal end 42 (para 23 and 24);
a pulse generator 302 contained within the housing 14 (para 17, 60, and 63);
a fixation component 32 coupled to the distal end of the housing, the fixation component configured to fixate the housing to a first location (para 18);
a leadlet 15/16 comprising:
a leadlet body 15 extending from a first end 60 to a second end 62, wherein the first end 60 is coupled to the housing proximate the proximal end 44 (para 27, figures 2 and 3A);
at least one electrical conductor positioned within the leadlet body (para 39, member 16/116 is coupled to an electrical conductor extending through body 15/115); and
a plurality of electrodes 22 and 20 (electrodes 120 of figure 3A) operably coupled to the pulse generator 302, wherein at least one electrode 20 of the plurality of electrodes is positioned on the distal end 42 of the housing 14, wherein at least one leadlet electrode 20/120 of the plurality of electrodes is positioned on the second end 62 of the leadlet 16.
Bonner et al. does not disclose the feature of a fixation device coupled to the second end of the leadlet body, the fixation device configured to fixate the second end of the leadlet to a second location. Bonner et al. include a floatation element 18 on the second end 62 of leadlet 16, wherein the floatation element 18 is provided to hold the lead 16 in an extended position following implantation (para 31). In view of this, floatation element 18 of Bonner et al. may be construed to be a passive fixation device that holds the leadlet in place. However, the Examiner looks to Eggen et al. to show a leadless pacemaker 112 comprising a leadlet 130 at one end of housing 150 and a fixation component 240 as the other end of housing 150 (figure 3A). The device of Eggen et al. is substantially similar to that of Bonner et al. Eggen et al. also teach a fixation element 120 located at an end of leadlet 130 that includes one or more tines to anchor the electrode at the desired pacing site (para 42). In view of this, it is considered to have been obvious to one of ordinary skill in the art to modify the second end 62 of leadlet 16 of Bonner et al. to by replacing the floatation element 18 with the tine fixation element 120 of Eggen et al. to provide more secure mechanical anchoring of the leadlet electrodes 20/120 at the desired site for sensing. The floatation element of Bonner et al. and the tines of Eggen et al. are recognized as similar passive fixation elements for maintaining leadlet extension electrodes at a desired location away from the pacemaker housing. The modification is considered to comprise the substitution of a known passive fixation element for another for predictably maintaining an electrode at a desired location.
In regard to claim 16, in Eggen et al., the first location is a right atrium (figure 1).
In regard to claim 18, in Bonner et al., the first location is a right ventricle (figure 1).
In regard to claim 19, in Eggen et al., the first location is a right atrium (figure 1) (the housing and leadlet may both be in the right atrium).
In regard to claim 20, Bonner et al. teaches that the leadlet 16 may have a length between 3-15 cm in length. Thus, Bonner et al. encompasses lengths greater than 10 cm.
Claims 17 and 19 is/are rejected under 35 U.S.C. 103 as being obvious over Bonner et al. (US Publication no. 2017/0028194) in view of Eggen et al. (US Publication no. 2013/0310723), further in view of Karst et al. (US Publication no. 2013/0325081).
In regard to claims 17 and 19, Bonner et al. in view of Eggen et al. are considered to substantially suggest the invention as claimed, including placement of the leadless pacemaker housings in the right atrium (Eggen et al.) and right ventricle (Bonner et al.). In this manner, Bonner et al. demonstrates capability for placement in the right ventricle as the first location, and Eggen et al. demonstrates capability for placement in the right atrium as the first location and for placement in the right atrium as the second location. Neither describe the configurations of first location in right ventricular with second location in right atrium nor first location in right atrium with second location in right ventricle. Karst et al. in figure 9 show a leadless pacemaker housing 902 located in a first location of the right ventricle and a leadlet 904 with electrodes 908, 910 at a second location of the right atrium (para 89-92). This configuration allows for synchronizing pacing of right ventricle from signals originating in the right atrium. Additionally, the structure depicted in Karst et al. is considered capable of reaching from the right atrium to right ventricle. The chambers recited are known for providing sensing and pacing functions, and selection of which chamber to provide as the first location and second location is considered to be based on the intended desired result or conduction anomaly to be mediated by pacemaking function. Therefore, it is considered to have been obvious to one of ordinary skill in the art to modify the cited prior art to provided sensing and pacing functions across atrial and ventricular chambers since it is demonstrated by Karst et al., and the modification would comprise the application of a known technique to a known device to yield a predictable therapeutic result.
Allowable Subject Matter
Claims 23-34 are allowed.
Claims 21 and 22 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: the prior art fails to teach the feature for the counter-rotation of the leadlet to cause the leadlet to store twist as in the torqued state as claimed. Nor is there teaching for a helix located at the tip of the leadlet body.
Li (US Patent no. 5,716,390) recognizes build-up of torque during rotation of an active fixation lead. However Li teaches this is undesirable since the build up of torque may cause lead perforation and is inconvenient and time consuming.
Dutcher et al. (US Patent no. 4,209,019) is directed to the released on residual torque imparted on a lead caused by rotational forces imparted thereon to engage a helical fixation element to tissue. Dutcher et al. do not teach torquing the lead in order to drive the helical fixation element into the tissue.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN T GEDEON whose telephone number is (571)272-3447. The examiner can normally be reached M-F 8:00 am to 5:30 PM ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David E. Hamaoui can be reached at 571-270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN T GEDEON/Primary Examiner, Art Unit 3796 29 July 2026
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