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 Objections
Claim 34 is objected to because of the following informalities: in line 7, “stimulation” should read --stimulation assembly--. Appropriate correction is required.
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.
Claims 17 and 18 are rejected under 35 U.S.C. 102(a)(1) and (2) as being anticipated by Hakki et al. (US 9,775,991, hereinafter “Hakki”).
In regards to claim 17, Hakki discloses a system for stimulating cardiac tissue of a patient (col. 9, lines 5-8; “maintain contact with the lining of the surrounding tissues (such as blood vessels, or heart chambers”), comprising:
a delivery catheter (Fig. 4, element 11) having a distal portion (Fig. 4, distal portion of element 11), wherein the delivery catheter is configured to at least partially advance an implantable stimulation assembly through a vasculature of the patient to the cardiac tissue (col. 9, lines 5-8; “maintain contact with the lining of the surrounding tissues (such as blood vessels, or heart chambers”); and
an acoustic transducer coupled to the distal portion of the delivery catheter, wherein the acoustic transducer is configured to generate acoustic energy and to direct the acoustic energy toward the stimulation assembly when an electrode of the stimulation assembly contacts the cardiac tissue (Fig. 2, element 51, “generator”; col. 11, lines 23-27, “the generator produces ultrasound energy that is transmitted to the electrodes equipped with receiver transducer circuitry operable to convert ultrasound energy to electric energy for transmission to the electrodes”).
In regards to claim 18, the system further comprises the stimulation assembly, wherein the stimulation assembly includes circuitry configured to receive the acoustic energy, convert the acoustic energy to electrical energy, and output the electrical energy to the electrode for delivery to the cardiac tissue (element 10; col. 11, lines 23-27, “the electrodes equipped with receiver transducer circuitry operable to convert ultrasound energy to electric energy for transmission to the electrodes”).
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.
Claims 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Hakki in view of Melodia et al. (US 2019/0313908, hereinafter “Melodia”).
Hakki discloses the essential features of the claimed invention including an acoustic transducer that is configured to generate the acoustic energy at a level sufficient to cause the circuitry of the stimulation assembly to output the electrical energy at a predetermined level (col. 11, lines 23-27; col. 7, lines 61-67, high and low voltage pacing). Hakki does not expressly disclose wherein the circuitry of the stimulation assembly further includes a voltage limiter configured to limit a voltage of the electrical energy output to the electrode to at or below a predetermined level.
However, Melodia in the same field of endeavor of ultrasound powered implantable devices teaches providing circuitry of a stimulation assembly that further includes a voltage limiter configured to limit a voltage of the electrical energy output to the electrode to at or below a predetermined level (par. 0176, “The power management unit, in its most basic form, contains a rectifier circuit 134 and a low dropout (LDO) regulator 148 to limit the voltage delivered to the load, which can be a sensing or actuation unit 138 (a medical device including, e.g., a sensor, an actuator, a drug pump, a heart stimulator, etc.)”) to provide the predictable results of keeping applied stimulation within limits set by the FDA (par. 0235).
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 Hakki by providing circuitry of a stimulation assembly that further includes a voltage limiter configured to limit a voltage of the electrical energy output to the electrode to at or below a predetermined level to provide the predictable results of keeping applied stimulation within limits set by the FDA.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Hakki in view of Moore et al. (US 9,283,392, hereinafter “Moore”).
Hakki discloses the essential features of the claimed invention including the capability of sensing (col. 7, lines 61-67). Hakki does not expressly disclose a controller configured to detect the electrical energy delivered to the cardiac tissue by the electrode and to determine one or more pacing threshold parameters of the cardiac tissue based on the detected electrical energy.
However, Moore in the same field of endeavor of ultrasound powered implantable devices teaches providing a controller configured to detect the electrical energy delivered to the cardiac tissue by the electrode and to determine one or more pacing threshold parameters of the cardiac tissue based on the detected electrical energy (col. 12, lines 4-14) to provide the predictable results of optimizing the location and energy applied by the stimulator (col. 11, line 58 to col. 12, line 28).
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 Hakki by providing a controller configured to detect the electrical energy delivered to the cardiac tissue by the electrode and to determine one or more pacing threshold parameters of the cardiac tissue based on the detected electrical energy to provide the predictable results of optimizing the location and energy applied by the stimulator.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Hakki in view of Reddy et al. (US 10,675,476, hereinafter “Reddy”).
Hakki discloses the essential features of the claimed invention including the capability of sensing (col. 7, lines 61-67). Hakki does not expressly disclose a controller configured to detect the electrical energy delivered to the cardiac tissue by the electrode and to determine one or more electrical timing parameters of the cardiac tissue based on the detected electrical energy.
However, Reddy in the same field of endeavor of ultrasound powered implantable devices teaches providing a controller configured to detect the electrical energy delivered to the cardiac tissue by the electrode and to determine one or more electrical timing parameters of the cardiac tissue based on the detected electrical energy (col. 14, lines 46-56) to provide the predictable results of arrhythmia identification, or tailoring and/or optimizing therapy such as by observing whether pacing therapy delivery from a leadless pacemaker is capturing the heart or otherwise having an intended effect such as improving cardiac output and/or synchronization (col. 13, lines 8-14).
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 Hakki by providing a controller configured to detect the electrical energy delivered to the cardiac tissue by the electrode and to determine one or more electrical timing parameters of the cardiac tissue based on the detected electrical energy to provide the predictable results of arrhythmia identification, or tailoring and/or optimizing therapy such as by observing whether pacing therapy delivery from a leadless pacemaker is capturing the heart or otherwise having an intended effect such as improving cardiac output and/or synchronization.
Allowable Subject Matter
Claims 23-33 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.
Claims 34-37 are allowed.
The following is a statement of reasons for the indication of allowable subject matter: Hakki, taken alone or in combination with the remaining prior art of record fails to disclose or fairly render obvious the combination of elements recited in claim 23, including the body and hook mechanism configured to pull the tissue and electrode toward and into engagement with each other (Hakki’s elements 13 push); the body and loops of claim 33 wherein the stimulation assembly is configured to be advanced toward the tissue over a suture extending through the loops; or the requirement of claims 34 and 35 that the stimulation assembly is configured to be advanced through the catheter.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Sweeney (US 6,654,638) is another example of an acoustically-powered stimulation device.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MICHAEL W KAHELIN/Primary Examiner, Art Unit 3792