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 .
Response to Arguments
Applicant’s arguments, see pg. 6-7, filed 06/24/2025 regarding the rejection of claim 8 under 35 U.S.C. 112(a) have been fully considered but they are not persuasive.
It is the Examiner’s position that there is not support for the subject matter of claim 8 in combination with the subject matter of claim 1, from which claim 8 depends.
The Examiner agrees with Applicant assertions that the specification, as originally filed, provides support for the support structure having a portion that does not include piezoelectric material, the portion of the support structure with the piezoelectric material can be coupled to the membrane and not the frame, and the portion of the support structure that does not include piezoelectric material can form part of the expandable frame.
However, there is not support for the portion of the support structure which comprises piezoelectric material being coupled to the membrane and not the expandable frame, as required by claim 1, and the portion of the support structure which does not include piezoelectric material being incorporated into the expandable frame, as required by claim 8.
In other words, there is not support for the support structure simultaneously including a portion that is coupled to the membrane and not the expandable frame and a portion that is incorporated into the expandable frame.
Applicant’s arguments, see pg. 6-13, filed 06/24/2025 regarding the rejection of claims 1 and 21 under 35 U.S.C. 103 have been fully considered but they are not persuasive.
Applicant argues that the cited references VanTassel et al. (US 6,652,556), Marquez et al. (US 2017/0258585), and Genereux et al. (US 2019/0175111), fail to teach “the support structure comprising energy-harvesting piezoelectric material that is coupled to the membrane and not the expandable frame” as recited by claim 1.
Applicant first argues, see pg. 9, that the Office Action failed to identify a reference that teaches a support structure coupled to the membrane wherein the support structure that is coupled to the membrane includes energy-harvesting piezoelectric material.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
The Examiner maintains that the combination of VanTassel and Marquez teaches a support structure as claimed. VanTassel and Marquez simply fail to teach the support structure coupled to the membrane and not the expandable frame as claimed.
Genereux expressly teaches mounting electronic components on or within various parts of a prosthetic implant including integrating the components within struts of an expandable stent frame or within and/or on any covering or coating of the stent frame (see [0011] and [0016]). In other words, Genereux teaches that mounting electrical components on or in a frame is a suitable alternative to mounting the components on or in a covering or coating (i.e., membrane) of a prosthetic implant.
The claimed support structure is an electrical component. Therefore, it would have been obvious to one of ordinary skill in the art to mount the support structure of VanTassel and Marquez to the membrane, since fixing electrical components to a membrane of a prosthetic implant was known in the art as a suitable alternative to integrating the components into the frame, as evidenced by Genereux.
Applicant appears to argue, see pg. 10, that Marquez teaches away from the support structure not being coupled to the expandable frame and cites paragraph [0014] as showing the power generation of Marquez is associated with the deflection of the frame assembly. Applicant contrasts that with the device of the application, stating that the “power generation device of claim 1 is expressly not associated with the expandable frame” since claim 1 requires that the energy-harvesting piezoelectric material is coupled to the membrane and not the expandable frame.
It is unclear how Applicant construes the term “associated” in this context. It is the Examiner’s position that all of the device components in claim 1 are a part of a singular device and are therefore associated.
It is further noted that the power generation of the device of the application appears to work similarly as described in paragraph [0014] of Marquez. Paragraph [0083] of the instant application describes the “deflection activity of the frame 101 and/or the membrane [provides for] power generation” (see also paragraphs [0021] and [0066] which describe that the piezoelectric polymers are “configured to generate electrical power from mechanical deflections or deformations”).
While claim 1 recites “energy-harvesting piezoelectric material that is coupled to the membrane and not the expandable frame”, it is understood based on the Specification and Figures, that “coupled” in this context means “directly coupled” or “directly in contact with”, because all of the claimed device components are connected in some way.
It is the Examiner’s position that the device of the combination of VanTassel, Marquez and Genereux teaches a support structure as claimed that is coupled to the membrane and not the expandable frame.
Regarding Applicant’s argument that the Marquez teaches away from the combination, the Examiner disagrees. Paragraph [0014] of Marquez states that “[the] power generator can be connected to, integrated with, and/or otherwise associated with the frame assembly of the prosthetic implant”. It is understood, based on this disclosure, that the power generator of Marquez does not need to be directly connected to the frame assembly in order to function as intended.
In the device of the combination of VanTassel, Marquez and Genereux, the power generator would be directly coupled to the membrane and not the expandable frame. However, the power generator would still be connected to and associated with the expandable frame since all of the device components are connected.
In response to applicant's argument that there are particular advantages to affixing the support structure to the membrane as opposed to the expandable frame, see arguments pg. 11, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
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 8 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 8 recites “wherein a portion of the support structure that does not include the energy-harvesting piezoelectric material is incorporated into the expandable frame”.
It is the Office’s position that there is support in the Specification and Figures, as originally filed, for the support structure including other components that are not piezoelectric material. For example, the support structure “can comprise layers of piezoelectric material separated by conductive (e.g., metal) plates” (see Specification [0067]) and the support structure can include a strain gauge (see Specification [0077]). The is also support in the Specification and Figures, as originally filed, for the support structure being coupled to the membrane and not the expandable frame (see Specification [0005] and [0070]).
However, it is the Office’s position that there is not support for the support structure including other components that are not piezoelectric material and those components being incorporated into the expandable frame.
Therefore “wherein a portion of the support structure that does not include the energy-harvesting piezoelectric material is incorporated into the expandable frame” is considered new matter.
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 1-7, 9, 11-14 and 21-25 are rejected under 35 U.S.C. 103 as being unpatentable over VanTassel et al. (US 6,652,556), in view of Marquez et al. (US 2017/0258585), and further in view of Genereux et al. (US 2019/0175111).
Regarding claims 1, 4, 5, 9, 21, 22, 24 and 25, Van Tassel discloses a device (440, see Fig. 31-33) for occluding a left atrial appendage (LAA) of a subject, the device comprising: a membrane (40) with an outer surface and an inner surface, the membrane configured to inhibit passage of blood (the membrane inhibits the passage of clotted blood, see Abstract); an expandable frame (440) at least partially covered by the membrane (the membrane at least partially covers the frame, see col. 15, lines 43-47), the expandable frame configured to support the membrane in the LAA to substantially occlude the LAA (the frame supports the membrane in the LAA, see col. 15, lines 23-30); and a plurality of physiological sensors (the device may include a plurality of sensors, see col. 3, lines 7-20) coupled to the outer surface of the membrane (the sensors may be built into the membrane, which would make them coupled to the outer surface of the membrane, see col. 11, lines 14-17), wherein the membrane (40) forms a dome structure (the frame and membrane may alternatively have the arrangement of Fig. 53, where the membrane is shown as having a dome structure).
VanTassel fails to teach a support structure coupled to the membrane, the support structure comprising energy-harvesting piezoelectric material that is coupled to the membrane and not the expandable frame and configured to harvest energy from environmental sources within the LAA, the plurality of physiological sensors configured to receive power from the energy harvested by the support structure, wherein the circuitry includes a battery that is recharged using the received power, and wherein the support structure comprises a strain gauge that is adapted to change electrical resistance responsive to deflections of the support structure to generate data related to deflection of the expandable frame.
Marquez, in the same field of art, teaches a similar device (a prosthetic implant, see [0007]) comprising sensors (320 see Fig. 3) and circuitry, a support structure (a piezo-electric polymer electricity generator, see [0090]) coupled to the expandable frame (the piezoelectric generator can be can be connected to, integrated with, and/or otherwise associated with the expandable frame, see [0014]) configured to harvest energy from environmental sources within the LAA, a plurality of physiological sensors, the plurality of physiological sensors configured to receive power from the energy harvested by the support structure (the generator harvests energy from blood flow-induced vibrations to power electronic components such as sensors, see [0090]), wherein the circuitry receives power from the energy harvested by the support structure (power source for the circuitry can be harvested from the environment by the support structure, see [0090] and [0110]), wherein the circuitry includes a battery that is recharged using the received power (the circuitry may also include a battery, see [0110]), and wherein the support structure further generates data related to blood pressure (the piezoelectric generator generates data about the blood flow rate which is related to blood pressure, see [0090]), and wherein the support structure comprises a strain gauge that is adapted to change electrical resistance responsive to deflections of the support structure to generate data related to deflection of the expandable frame (the device can include a strain gauge configured to provide a sensor signal indicating deflection of the frame, see [0026]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the device of VanTassel to include the support structure of Marquez since doing so would have provided the device of VanTassel with a means for generating power for the sensors and to measure strain on the device.
The combination of VanTassel and Marquez fails to teach the piezoelectric material of the support structure is coupled to the membrane not the expandable frame, the strain gauge is coupled to the membrane, and the support structure is affixed to the outer surface of the membrane and extends over a center of the dome structure.
Genereux, in the same field of art, teaches mounting sensors and electronic components on or within various parts of a prosthetic implant including integrating the components within struts of an expandable stent frame or within and/or on any covering or coating of the stent frame (see [0011] and [0016]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to couple the support structure of VanTassel and Marquez (i.e., the piezoelectric material and strain gauge) to the membrane and not the expandable frame, since Genereux teaches fixing electrical components to a membrane of a prosthetic implant was known in the art as a suitable alternative to integrating the components into the frame.
VanTassel, Marquez, Genereux fail to expressly teach affixing the support structure to the outer surface of the membrane and extending over a center of the dome structure.
It would have been an obvious matter of design choice to one of ordinary skill in the art, before the effective filing date of the claimed invention, to affix the support structure of VanTassel, Marquez, and Genereux to the outer surface of the membrane and extending across a center of the dome structure, since Applicant has not disclosed that the claimed arrangement provides any advantage, serves a particular purpose or solves a stated problem. Further one of ordinary skill in the art, would have expected the device of VanTassel, Marquez, and Genereux to perform equally well with either the support structure generally attached to the membrane as taught by VanTassel, Marquezm, and Genereux or the support structure being specifically affixed to the outer surface of the membrane and extending across a center of the dome structure as claimed since both arrangements perform the same function of attaching the support structure to the membrane of the implant.
Regarding claim 2, VanTassel discloses the device comprising circuitry with electrical connections to the plurality of physiological sensors (the sensors can be connected with circuitry, see col. 3, lines 7-20 and col. 11, lines 14-29).
Regarding claim 3, VanTassel discloses the device includes a transmitter to transmit data acquired by one or more of the plurality of physiological sensors (the device includes a telemetry system for transmitting information detected by the sensors outside of the patient, see col. 3, lines 15-20). VanTassel fails to teach an antenna coupled to the circuitry.
Marquez teaches a telemetry system (see Fig. 3) comprising an antenna (395) coupled to circuitry wherein the circuitry includes a transmitter (330) coupled to the antenna to transmit data acquired by one or more of the plurality of physiological sensors (the transmitter 320 wirelessly transmits data collected by the sensors to a device outside the patient’s body, see [0106]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to substitute the telemetry system of VanTassel with the telemetry system of Marquez since doing so would have yielded nothing more than predictable results, namely, transmission of data collected by the sensors outside of the patient. KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Regarding claim 6, Marquez further teaches the energy-harvesting piezoelectric material of the support structure (a piezo-electric polymer electricity generator, see [0090]) includes a stack of piezoelectric polymers (the piezoelectric electricity generator can be a stack of piezoelectric material and it is understood that the material is polymer material since the support structure is a “piezoelectric polymer electricity generator”, see [0090] and [0190]) configured to generate electrical power from mechanical deflections or deformations (see [0090]).
Regarding claim 7, Marquez further teaches the energy-harvesting piezoelectric material of the support structure (a piezo-electric polymer electricity generator, see [0090]) comprises layers of piezoelectric material separated by conductive plates (the electricity generator can comprise can comprise layers of piezoelectric material separated by conductive plates, see [0191]).
Regarding claims 11, 12 and 13, VanTassel, Marquez, and Genereux teach the device of claim 1. VanTassel further discloses the device can include a telemetry system for transmitting data outside the patient (see col. 3, lines 15-20). VanTassel fails to teach the device comprising an ultrasound receiver module configured to receive ultrasound transmissions, wherein the ultrasound receiver module is configured to receive power from an external ultrasound source using ultrasound, and an ultrasound transmission module configured to transmit data to the external ultrasound source using ultrasound.
Marquez teaches a telemetry system (see Fig. 8) comprising an ultrasound receiver module (811) configured to receive ultrasound transmissions (see [0125]), wherein the ultrasound receiver module is configured to receive power from an external ultrasound source using ultrasound (the receiver can receive power from the transmitter module 853, see [0125]), and an ultrasound transmission module configured to transmit data to the external ultrasound source using ultrasound (the receiver can also have ultrasound transmission functionality, see [0125]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to substitute the telemetry system of VanTassel with the telemetry system of Marquez since doing so would have yielded nothing more than predictable results, namely, transmission of data collected by the sensors outside of the patient. KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Regarding claim 14, VanTassel further discloses wherein the expandable frame (440, see Fig. 32) includes a plurality of longitudinally extending beams (468) coupled together using pairs of struts (462).
Regarding claim 23, the combination of VanTassel, Marquez and Genereux teaches the device of claim 21, wherein the support structure extends from a frame base of the expandable frame over the membrane (the combination of VanTassel, Marquez and Genereux teaches the support structure extending over the membrane and the portion of the expandable frame 440 that is covered by the membrane 40 can be considered a frame base, see Fig. 33 of Genereux).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over VanTassel, Marquez, and Genereux, as applied to claim 1 above, further in view of Carney (US 5,368,040).
Regarding claim 10, VanTassel and Marquez teach the device of claim 1. VanTassel further discloses wherein the plurality of physiological sensors includes a pressure measurement sensor (see col. 3, lines 12-15 and col. 11, lines 14-17). VanTassel fails to explicitly disclose the pressure measurement sensor is an absolute pressure measurement sensor.
Carney, in the same field of art, teaches incorporating an absolute pressure sensor into an implantable device for monitoring pressure (see Abstract).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to substitute the pressure sensor of VanTassel with the absolute pressure sensor of Carney since doing so would have yielded nothing more than predictable results, namely, monitoring of pressure within the heart. KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Conclusion
THIS ACTION IS MADE FINAL. 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 SERENITY MILLER whose telephone number is (571)272-1155. The examiner can normally be reached Monday-Friday 8:00am-5pm.
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/SERENITY A MILLER/Examiner, Art Unit 3771
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771