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 .
Election/Restrictions
Applicant’s election without traverse of the invention of Group III (claims 24-31) in the reply filed on September 2, 2025 is acknowledged. New claims 50-56 have been included within this grouping.
Claim Objections
Claims 29 and 30 are objected to because of the following informalities: in claim 29, use of the word “patent” is an obvious typographical error; the word “method” is missing from the preamble of claim 30. Appropriate correction is required.
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.
Claim 30 is 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.
Reference to “the sensor” lacks antecedent basis.
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.
Claim(s) 24-26, 50-52 and 54 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Markowitz et al. (Markowitz: Pub. No. 2011/0160801).
Regarding claim 24, Markowitz discloses a method of percutaneously implanting a medical implant in tissue of a patient (par. 0038; Fig. 1), the method comprising: providing a delivery device 8 (Fig. 1) having a power delivery system (pars. 0007, 0044: power may be delivered to the IMD via feed line 16; any combination of elements 18, 32, 34, 106 and 108 may also function in the capacity to deliver power) and a delivery sheath (catheter 20) carrying the medical implant, percutaneously positioning the delivery sheath in the patient's tissue, and testing the position of the medical implant by powering the medical implant within the delivery sheath by the power delivery system of the delivery device (see at least pars. 0039, 0064, 0065, 0071, 0073, 0116 and 0117 wherein prior to expulsion, the location suitability may be tested using the external device 18, with the power supplied to the implant by the external device).
Regarding claim 25, note par. 0079, where the IMD – which can be any of a wide variety of stimulator devices requiring electrodes for stimulating and sensing (see par. 0043) -- may be exposed for testing.
Regarding claim 26, note the discussion of testing above. It is inherent that if one is testing whether or not the IMD is located in a suitable position, one would necessarily reposition the IMD based on feedback from the testing in order to place the IMD in its optimal position.
Regarding claim 50, note Fig. 21 and electrical contact terminals 152 and 154 which allow electrical connection between the power delivery system and the power terminals of the implant.
Regarding claim 51, note at least pars. 0044 and 0109 and the use of a wireless power receiver (telemetry module 142) which can harvest wireless power from the external power delivery system.
Regarding claim 52, the wireless power transmitter (any form of the antenna for coupling to the wireless power receiver) is disposed in the delivery sheath as shown for example in Figs. 5-8.
Regarding claim 54, the delivery sheath of Markowitz includes a wireless power transmitter 22 disposed therein.
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.
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(s) 27-29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Markowitz et al. in view of Yeh et al. (Yeh: Pub. No. 2022/0314008).
Regarding claim 27, note par. 0043 and the suggestion that the IMD may be a neurostimulator. While Markowitz details an example of detecting the reaction of a patient while testing a pacemaker (see par. 0064), the teaching would have obvious parallel implications to testing suitable placements for neurostimulators. Yeh discloses a related neurostimulation device wherein testing of electrode positioning is performed during implant (par. 0006). Yeh teaches that one can detect a reaction of a patient (evoked response) while testing the position of the implant (pars. 0006, 0007, 0012-0014). Artisans concerned with maximizing the efficiency and effectiveness of stimulation while reducing the time required for implantation (see par. 0005), would have considered it an obvious matter of design to include such a feature in the method of Markowitz.
Regarding claim 28, Yeh teaches that muscle activity may be monitored and that an accelerometer may be used to determine the evoked response (pars. 0023, 0027, 0170). An accelerometer by design measures movement.
Regarding claim 29, Yeh discloses that a detected reaction of the patient may also be sensed by use of an electromyography (EMG) sensor (pars. 0013 and 0022). An EMG sensor by design detects neural signals.
Claim(s) 30, 31, 55 and 56 is/are rejected under 35 U.S.C. 103 as being unpatentable over Markowitz et al.
Regarding claim 30, Markowitz discloses the use of a display module 29 that may be used to display information regarding telemetry communication, testing, position and other data including sensor data (pars. 0045 and 0065). While the use of a graphical user interface (GUI) is not explicitly disclosed, Official Notice is taken that such display means are old and well-known in the medical device art. GUIs provide an easy-to-use familar interface that is visually appealing and improves efficiency by allowing easy navigation using recognizable visual icons to quickly make desired selections. Those of ordinary skill in the art looking to capitalize on these advantages, would have considered the use of a GUI as clearly obvious. Related comments apply to broader claim 31.
Regarding claims 55 and 56, any power source contained in external device 18 is considered an “external power source.” In any event, the particular form of the source is clearly not critical to the invention as the applicant covers practically all sources known to exist for powering electrical equipment. Artisans of ordinary skill in the art would have recognized that any suitable source would suffice, including well-known sources such as mains power, external batteries or wireless power receivers/transmitters. Official Notice is taken that such means are old and well-known in the electrical device arts, with the decision to employ one or the other depending on the application at hand (e.g., if a source of mains power is not readily available, the use of a battery provides a convenient solution).
Claim(s) 53 is/are rejected under 35 U.S.C. 103 as being unpatentable over Markowitz et al. in view of Bomzin et al. (Bomzin: Pub. No. 2019/0298991).
Regarding claim 53, Markowitz discloses that a guide 52 (see Fig. 9) may be used within the delivery catheter/sheath 50, and that the telemetry unit which may be used to provide power to the IMD, is contained within the guide 52 (par. 0057). While it is not explicitly stated that the delivery sheath is constrained in a position and orientation relative to the patient during use, such a step would have been considered obvious to surgeons and those of ordinary skill in the art because this would allow the implant to be delivered to the targeted site, while preventing movement of the delivery sheath distal tip away from the targeted site. Additionally, Markowitz indicates that the delivery sheath may be steered to a suitable site by operator control (par. 0039 and 0044). Such operator control of steering means would enable the position and orientation of the sheath relative to the patient is constrained by the steering means. In any event, Bomzin discloses a related delivery system also utilizing a delivery catheter/sheath wherein the sheath may be constrained in its position/orientation by the use of an anchor (Figs. 12 and 13). Such a feature prevents the delivery sheath from migrating from its intended target, thus increasing the chance for successful placement of stimulation electrodes at the targeted site. Any artisan concerned with maintaining the proper position of the delivery sheath at the targeted site, would have considered the step of constraining the delivery sheath’s position and orientation as common sense and a matter of obvious design.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KENNEDY SCHAETZLE whose telephone number is (571)272-4954. The examiner can normally be reached on the 2nd Monday of the biweek and W-F.
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/KENNEDY SCHAETZLE/Primary Examiner, Art Unit 3796
KJS
November 15, 2025