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 Group II and Species F in the reply filed on 06/02/2026 is acknowledged.
Claim Objections
Claims 45-47 are objected to because of the following informalities:
i. Regarding Claims 45-47, the claims are objected to as there is no Claim 44 listed, so the claims should be Claims 44-46 respectively. For clarity of current examination, the Examiner is referring to the currently listed claim/claim number combinations, but they should be adjusted moving forward.
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 47 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.
Regarding Claim 47, the limitation “comprises delivering cardiac pacing energy via the plurality of electrodes to stimulate an HIS bundle pacing” is indefinite as to what a “HIS bundle pacing” is or how it is stimulated. The Examiner is interpreting for the purpose of examination that the word “pacing” is duplicated, and the stimulation is to stimulate a HIS bundle.
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 37-43 and 45-46 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Publication 20090018599 awarded to Hastings et al (cited on the IDS dated 08/07/2024).
Regarding Claim 37, Hastings teaches a method of implanting a stimulation assembly at a target site of a septal wall of a heart of a patient (Para. 0039), the method comprising: positioning the stimulation assembly in a first ventricle of the heart (Para. 0039, “For example, the transmitter 20 may abut a septal wall 40 of the right ventricle 23, and the wireless seed assembly 26 may be placed on the septum of the left ventricle parallel to the septal wall 40 of the right ventricle 23”), wherein the stimulation assembly comprises a body (body 140), an anchor coupled to the body (Fig. 4, fixation elements 138), and circuitry positioned at least partially within the body, the circuitry being configured to receive acoustic energy from an external source and convert the acoustic energy to electrical energy (Para. 0058, “Similarly, a wireless electrode assembly (seed) 250 includes two conductors or wires 252, 254, each connected to one end of another ultrasonic transducer 256. Wires 252 and 254 also are connected to a seed circuit 216 within the seed 250, which may include capability for charge storage, electrical stimulation (pace) delivery, electrical sense, and information transmit, receive and storage. Seed 250 may correspond to any of the seeds shown in FIGS. 1-4 and described above. Ultrasonic coupling may provide an efficiency advantage because the beam produced upon transducer excitation may be more directed, permitting reduced loss when the receiving transducer is appropriately oriented relative to the transmitting transducer. Conversely, if the transmitted ultrasound beam only partially intersects receiver 256, the received energy may become too small to pace the tissue. The ultrasound energy transmission of FIG. 6A may thus be more orientation-dependent than the magnetic energy transmission of FIG. 5”); penetrating the septal wall of the heart with a distal tip portion of the anchor (Fig. 4, Para. 0039), wherein the stimulation assembly includes a plurality of electrodes positioned along the anchor between the distal tip portion and a proximal portion of the anchor (Fig. 4, electrodes 142 and 144); securing the anchor to the septal wall such that the body is positioned within the first ventricle and the plurality of electrodes contact tissue of the septal wall (Fig. 4, Para. 0050); and delivering electrical energy to the septal wall via the plurality of electrodes (Para. 0047).
Regarding Claim 38, Hastings teaches the method of claim 37, further comprising selectively delivering, via the circuitry, portions of the electrical energy to the plurality of electrodes according to a selected stimulation pattern (Para. 0085, “The controller may be programmed to deliver pacing pulses to leads in the ventricles at specific time delays relative to the sensed sinus beat (usually somewhat more than 100 msec, and may be a function of exertion sensed by an embedded accelerometer). Ventricle leads may be instructed to pace simultaneously or sequentially in a pattern that has been found to optimize cardiac hemodynamics”).
Regarding Claim 39, Hastings teaches the method of claim 37 wherein securing the anchor to the septal wall comprises deploying anchor members coupled to the anchor into tissue of the septal wall, wherein the anchor members are positioned distal to the plurality of electrodes Fig. 4).
Regarding Claim 40, Hastings teaches the method of claim 37 wherein securing the anchor to the septal wall comprises deploying anchor members coupled to the anchor into tissue of the septal wall, wherein the anchor members are positioned between a distal portion of the anchor and a distalmost one of the plurality of electrodes (Fig. 4).
Regarding Claim 41, Hastings teaches the method of claim 37 wherein the plurality of electrodes comprises a first electrode and a second electrode, wherein the first electrode is a cathode electrode and wherein the second electrode is an anode configured to electrically communicate with the first electrode (Para. 0050, “The assemblies 26 may each include two or more stimulation electrodes for providing electrical stimulation to cardiac tissue, and in some implementations may include two or more sense electrodes for sensing cardiac signals local to their implantation environment. In some implementations, the seeds 26 may measure voltages, for example, such as voltages associated with the heart's native conduction cycles or voltages associated with delivered pacing stimuli. In some implementations, the seeds 26 may contain a pressure sensor for measurement of blood pressure in the heart chamber. As described above, in some implementations the seeds 26 may include storage space for storing sensed or measured information and may further include a transmitter for wirelessly transmitting the information for use by the pacing controller 10. The assemblies 26 shown in FIG. 4 are exemplary, and variations are possible. For example, alternative fixation devices may be used, such as different hook, tine or screw arrangements”).
Regarding Claim 42, Hastings teaches the method of claim 37 wherein securing the anchor to the septal wall further comprises positioning a distal surface of the body adjacent to the septal wall, wherein the plurality of electrodes are first electrodes, and wherein the stimulation assembly further comprises a second electrode carried by a proximal surface (Fig. 4).
Regarding Claim 43, Hastings teaches the method of claim 42 wherein the first electrodes are cathode electrodes and wherein the second electrode is an anode configured to electrically communicate with the first electrodes (Para. 0050, “The assemblies 26 may each include two or more stimulation electrodes for providing electrical stimulation to cardiac tissue, and in some implementations may include two or more sense electrodes for sensing cardiac signals local to their implantation environment. In some implementations, the seeds 26 may measure voltages, for example, such as voltages associated with the heart's native conduction cycles or voltages associated with delivered pacing stimuli. In some implementations, the seeds 26 may contain a pressure sensor for measurement of blood pressure in the heart chamber. As described above, in some implementations the seeds 26 may include storage space for storing sensed or measured information and may further include a transmitter for wirelessly transmitting the information for use by the pacing controller 10. The assemblies 26 shown in FIG. 4 are exemplary, and variations are possible. For example, alternative fixation devices may be used, such as different hook, tine or screw arrangements”).
Regarding Claim 45, Hastings teaches the method of claim 37 wherein penetrating the septal wall comprises penetrating a needle into the septal wall, wherein the plurality of electrodes are positioned linearly along the needle (Para. 0070).
Regarding Claim 46, Hastings teaches method of claim 37 wherein positioning the stimulation assembly in the first ventricle comprises positioning the stimulation assembly in a left ventricle (Para. 0039, “For example, the transmitter 20 may abut a septal wall 40 of the right ventricle 23, and the wireless seed assembly 26 may be placed on the septum of the left ventricle parallel to the septal wall 40 of the right ventricle 23”).
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.
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.
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 47 is rejected under 35 U.S.C. 103 as being unpatentable over Hastings as applied to Claim 37 above, and further in view of U.S. Patent Publication 20190083800 awarded to Yang (cited on the IDS dated 08/07/2024).
Regarding Claim 47, Hastings teaches the method of Claim 37. Hastings does not teach wherein delivering electrical energy to the septal wall via the plurality of electrodes comprises delivering cardiac pacing energy via the plurality of electrodes to stimulate an HIS bundle pacing, but does teach the need for resynchronization therapy (Paras. 0006-0007).
However, in the art of cardiac stimulation (abstract), Yang teaches using a leadless stimulator to stimulate/pace the HIS bundle (Para. 0033) for the purpose of promoting AV synchrony (Para. 0003-0004).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hastings by Yang, i.e. by positioning the device of Hastings as in Yang, for the predictable purpose of improving the device of Hastings by performing further synchronization therapy, the need of which is set forth in Hastings and Yang above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jess Mullins whose telephone number is (571)-272-8977. The examiner can normally be reached between the hours of 9:00 a.m. to 5:00 p.m. PST M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Unsu Jung, can be reached at (571)-272-8506. The fax number for the organization where this application or proceeding is assigned is (571)-273-8300.
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/JLM/
Examiner, Art Unit 3792
/ALLEN PORTER/Primary Examiner, Art Unit 3796
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