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 § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 41 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 41 appears to be drawn to an unsupported mixing of embodiments. Claim 41 is dependent on claim 40. Claim 40 requires the “offset” described in Fig. 29Y-2 and par. 0276, the “offset” being described in par. 0276 as “[t]he offset 2956Y in the distal direction from line 2954Y going through electrode 2922Y.” Accordingly, the “offset” is described in the disclosure as the offset in the distal direction of the line passing through the proximal part in relation to the electrode 2922Y, and so the limitations of both claims 40 and 41 cannot be satisfied in light of the specification (i.e., the “offset” as described requires that the proximal part is not in line with the first electrode, directly in contradiction to the requirements of claim 41).
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.
(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.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) and (2) as being anticipated by Marshall et al. (US 2016/0158567, hereinafter “Marshall”).
In regards to claim 1, Marshall discloses an electrical lead for implantation in a patient (Fig. 4), the lead comprising:
a distal portion (Fig. 4, portion distal to element 24a) comprising one or more electrodes (element 32b) that are configured to generate therapeutic energy for biological tissue of the patient (par. 0006); and
a proximal portion (portion of lead proximal to and including 24a) coupled to the distal portion and configured to engage a controller (via element 34, par. 0043), the controller configured to cause the one or more electrodes to generate the therapeutic energy (par. 0043).
Claims 40, 41, 43 and 44 are rejected under 35 U.S.C. 102(a)(1) and (2) as being anticipated by Bonner (US 6,055,457, hereinafter “Bonner”).
In regards to claim 40, Bonner discloses an electrical lead for implantation in a patient (Fig. 11), the lead comprising:
a distal portion comprising one or more electrodes that are configured to generate therapeutic energy for biological tissue of the patient (Fig. 10, portion of lead distal to 412); and
a proximal portion coupled to the distal portion and configured to engage a controller (Fig. 10, element 412; col. 7, lines 11-16), the controller configured to cause the one or more electrodes to generate the therapeutic energy (abstract, “pacing lead system for pacing a patient’s heart”);
the distal portion of the lead comprising:
a distal part that includes a distal tip (Fig. 11, region distal to the bend in the atrium);
a bend including a first electrode (see annotated Fig. 11 below); and
a proximal part connected to the distal part at the bend (Fig. 11, region proximal to the bend);
wherein the lead is configured to have a deployed configuration where the bend allows the lead to have an "L-shape" when the proximal part and the distal part are approximately perpendicular in the deployed configuration (see annotated Fig. 11 below),
wherein, in the deployed configuration, the bend creates an offset of the proximal part of the lead in the distal direction, the offset placing the proximal part closer to the distal tip to facilitate contact of the first electrode with biological tissue of the patient (see annotated Fig. 11 below).
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In regards to claim 41, the bend places the proximal part “approximately” in line along the proximal part with the first electrode (as the only discussion of a lead having an “offset” as required by claim 40 is described in relation to Fig. 29Y-2 of Applicant’s disclosure (par. 0276), and assuming this embodiment falls within the scope of claim 41, Bonner’s electrode is likewise “approximately” in line with the electrode).
In regards to claim 43, the proximal part includes an S-shape (see Fig. 11’s double curve approximating an “S”).
In regards to claim 44, the bend is configured to increase the flexibility of the proximal part of the lead to facilitate maintaining contact with the biological tissue when the lead is in the deployed configuration (the bend allows for the flexibility of inserting the distal portion of the lead into the coronary sinus and maintain contact with tissue within the coronary sinus; col. 7, lines 16-46).
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.
Claim 45 is rejected under 35 U.S.C. 103 as being unpatentable over Bonner in view of Garcia (US 4,516,584, hereinafter “Garcia”).
Bonner discloses the essential features of the claimed invention, but does not expressly disclose the proximal part including one or more grooves or holes for suturing the proximal part to the patient.
However, Garcia in the same field of endeavor of implantable electrical leads teaches providing a proximal part including one or more grooves or holes for suturing the proximal part to the patient (Fig. 1, element 20) to provide the predictable results of secure fixation of the lead in its desired implantation location (col. 1, lines 6-10).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Bonner by providing a proximal part including one or more grooves or holes for suturing the proximal part to the patient to provide the predictable results of secure fixation of the lead in its desired implantation location.
Response to Arguments
Applicant's arguments filed 6/18/2026 have been fully considered but they are not persuasive in part and moot in part.
In regards to claim 1, Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
Claims 40, 41 and 43-45 are rejected above in view of newly-cited Bonner, necessitated by amendment.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Krishnan et al. (US 6,961,621) is another teaching that appears to anticipate at least claims 1 and 40 (Fig. 1).
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 MICHAEL W KAHELIN whose telephone number is (571)272-8688. The examiner can normally be reached M-F, 8-5.
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, Benjamin Klein can be reached at (571)270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL W KAHELIN/ Primary Examiner, Art Unit 3792
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