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 invention I, directed to a valve monitoring assembly and species a, Figure 6, directed to claims 1-10 in the reply filed on 10/01/2025 is acknowledged. Claims 11-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
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) 1-3 and 9-10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hunter WO2015/200707.
Regarding Claim 1, Hunter discloses a valve monitoring assembly (abstract, paragraphs [0007], [0013], [0017], [0123]), comprising: a prosthetic valve 10 comprising: a frame having an inflow end portion and an outflow end portion (paragraphs [0014-0015], [0033], [0056] and [0080] and as seen in Figures 5A-5B and 10A-13C); and a plurality of leaflets positioned at least partially within the frame and configured to regulate a flow of blood through the prosthetic valve (paragraphs [0014-0015], [0033], [0056] and as seen in Figures 5A-5B and 10A-13C); and a monitoring apparatus comprising: at least one sensor 22, 22b, 24, 42, 46 associated with the prosthetic valve (paragraphs [0022], [0067], [0070-0071]), wherein the at least one sensor 22, 22b, 24, 42, 46 is selected from the group consisting of: flow sensor, pressure sensor, and temperature sensor (see Figure 15, paragraphs [0058-0062], [0080], [0082-0083], [0115], [0123]); a local control circuitry in communication with the at least one sensor at least one communication component 130, in communication with the local control circuitry, and configured to wirelessly transmit signals (see Figure 15, paragraphs [0124-0125]); and an energy harvesting power source, configured to be secured to a patient and comprising a self-powered energy harvesting mechanism (paragraph [0131]) and an energy storage member (paragraphs [0112-0113]), wherein the energy storage member is configured to store energy generated by the self-powered energy harvesting mechanism (paragraphs [0113-0115], [0124]), and wherein the energy harvesting power source is configured to supply power to the at least one sensor, the local control circuitry and/or the at least one communication component (paragraphs [0013-0115), [0124-0125]).
Regarding Claim 2, Hunter discloses wherein the energy harvesting power source is coupled to the local control circuitry (paragraphs [0114-0115]).
Regarding Claim 3, Hunter discloses wherein the energy harvesting power source further comprises a first tissue engagement feature configured to facilitate attachment of the energy harvesting power source to a tissue of the patient (the sensors are shown to be located along the apices and commissure regions of the stent frame, see Figures 13A-13C, paragraph [0114-0115]).
Regarding Claim 9, Hunter discloses wherein the monitoring apparatus further comprises at least one communication channel connected to the local control circuitry (single receiving circuit, see paragraph [0025]) and to the at least one sensor, and configured to deliver signals there-between (paragraphs [0025], [0120], [0124]).
Regarding Claim 10, Hunter discloses wherein the prosthetic valve is radially expandable and compressible between a radially compressed state and a radially expanded state (paragraphs [0037-0038], [0047-0048]), wherein the frame comprises a plurality of cells bound between strut portions (paragraphs [0047-0048], [0080] and as seen in Figures 10A-13C), and wherein the at least one communication channel extends along at least some of the strut portions (paragraphs [0115], [0120], [0124], see Figures 10A-13C).
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.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hunter WO2015/200707 in view of Shuler U.S. Publication 2013/0317367 A1.
Regarding Claim 4, Hunter does not expressly discloses wherein the self-powered energy harvesting mechanism is a clockwork-type energy harvesting mechanism, comprising: an oscillating weight configured to translate externally applied accelerations into oscillating rotational motions thereof; a mechanical rectifier coupled to the mechanical weight, and configured to translate the oscillating rotational motions into a unidirectional rotation; a spring coupled to the mechanical rectifier; and an electromagnetic micro generator coupled to the spring, and configured to convert motion of the spring into an electrical signal. Shuler teaches a monitoring assembly in the same field of endeavor comprising a device 505 having a sensor 405, the sensor is wireless to track motion or movement of the body and is supply by a power and re-chargeable energy source 601 (paragraph [0126]), the energy source is a kinetic energy device and comprises oscillating weights that are turned by the movements of the patient on which the sensor is worn, these movements by the patient may create a magnetic charge to the sensor 405 which is turned into electricity that is needed to power the watch (paragraphs [0108], [0126]). 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 Hunter’s self-powered energy harvesting mechanism to be a clockwork-type energy harvesting mechanism in the form of a kinetic energy device comprising oscillating weights that are turned by the movements of the patient on which the sensor is worn, these movements by the patient may create a magnetic charge to the sensor which is turned into electricity that is needed to power the watch. This modification is for one self-powered energy source for another.
Claim(s) 5-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hunter WO2015/200707 in view of Kim et al. U.S. Publication 2019/0133472 A1.
Regarding Claims 5, 6, Hunter does not expressly disclose wherein the self-powered energy harvesting mechanism is a solar energy harvesting mechanism, comprising a solar module comprising at least one solar cell, wherein the solar energy harvesting mechanism further comprises a power converter functionally coupled to the solar module. Kim et al. teaches a monitoring assembly in the same field of endeavor comprising a stent 200 having a frame and a monitoring apparatus comprising a sensor 210 associated with the stent frame (paragraphs [0059], [0061-0062] and as seen in Figure 4), energy storage 330, communication component 320 and an energy harvesting power sources 310 that is configured to supply power to the sensor and may include solar cell power source to allow the pressure sensor to be powered through ecofriendly energy that relaces the need for a battery and allow for self-powered energy source (paragraphs [0067-0068]). 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 Hunter’s self-powered energy source to further include solar cell as taught by Kim for the purpose of allowing the sensor to be powered through ecofriendly energy that replaces the need for a battery and allow for self-powered energy source.
Regarding Claims 7, 8, Hunter discloses wherein the at least one communication component comprises a remote communication component in the form of an antenna (paragraph [0120] and [0125]) for sending and receiving data from the sensor. However, Hunter does not expressly disclose the remote communication component is configured to wirelessly or electromagnetically transmit energy generated by a solar energy harvesting mechanism. Kim et al. teaches a monitoring assembly in the same field of endeavor comprising a stent 200 having a frame and a monitoring apparatus comprising a sensor 210 associated with the stent frame (paragraphs [0059], [0061-0062] and as seen in Figure 4), the sensor includes a coil which generates current and the power module 310 in the form of an energy harvesting power sources 310 may wirelessly supply power to the coil through electromagnetic induction (paragraph [0013], [0065-0066]), wherein the power sources is an ecofriendly energy that is configured to supply power to the sensor and may include solar cell power source to allow the pressure sensor to be powered through ecofriendly energy that replaces the need for a battery and allow for self-powered energy source (paragraphs [0067-0068]). 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 Hunter’s self-powered energy source to further include solar cell as taught by Kim for the purpose of allowing the sensor to be powered through ecofriendly energy that replaces the need for a battery and allow for self-powered energy source.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEEMA MATHEW whose telephone number is (571) 270-1452. The examiner can normally be reached on Monday-Friday 9 am – 5 pm.
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/SEEMA MATHEW/
Primary Examiner, Art Unit 3774