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 Amendment
Receipt is acknowledged of applicant's amendment filed on 12/12/25. Claim 72 is cancelled. Claims 73-74 are new. Claims 22, 24, 29-31, 40 and 56-67 remain withdrawn. Claims 1, 5-48, 50 and 56-74 are currently pending and an action on the merits is as follows.
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.
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(s) 1, 5-9, 12, 19, 20, 21, 23, 25-28, 37-39, 41-45 and 73-74 are rejected under 35 U.S.C. 103 as being unpatentable over US20090024042 to Nunez et al. (Nunez) in view of US20180098772 to Goldshtein et al. (Goldshtein) and US 7128073 to van der Burg et al. (Burg).
In regards to claims 1, 5, 20, 21, 25, 37, 38, 42, 44 and 45, Nunez teaches an implantable measurement device comprising: a first anchoring component configured to engage a first inner wall defining a first chamber of a heart; a first sensing element coupled to the first anchoring element, the first sensing element configured to perform physiologic measurement in the first chamber (see entire document, for example Fig. 2 and para. 0048 and 0050, pressure sensor 24); a second anchoring component configured to engage a second inner wall defining a second chamber of a heart that is different from the first chamber; a second sensing element coupled to the second anchoring component, the second sensing element configured to perform physiologic measurement in the second chamber of the heart (see entire document, for example Figs. 2, 13-17 and para. 0048, 0055, 0091, the unit 20 can have a sensor 24 on either side of the device on both substrates); the first and second anchoring components are configured to be positioned opposingly against an atrial septum of a patient (see entire document, for example Fig. 2 and para. 0047, 0055, 0076 and 0091, substrates 344 and 340 which act as anchors); and wherein the first sensing element is disposed in the first anchoring component and the second sending element is disposed in the second anchoring component (see entire document, for example Figs.2, 13-16, the sensors 24 are on both anchor substrates); sensor perform physiological measurements (see entire document, for example para. 0030-0032, 0045 and 0064, blood pressure is measured); and teaches the measurement electronics, such as on an application specific integrated circuit (ASIC), for sensing and/or processing the signal of the sensor. In one embodiment, the ASIC includes a sensor. In an alternative embodiment, the ASIC is separate from the sensor (see entire document, for example para. 0031, 0045, 0064, 0066, 0090), but does not explicitly teach an electronics housing component configured to extend between the first and second anchoring components.
Goldshtein teaches an electronics housing component coupled to the first anchoring component and the second anchoring component, the electronics housing component configured to extend between the first and second anchoring components for the purpose of receiving and transmitting the sensor measurements taught by Nunez (see entire document, for example para. 0054 "the implant includes sensing elements are integrated into a tube shaped (rigid) implant body which contains the electronic circuitry" and para. 0055 "the implant includes several subassemblies, for example: ….(iii) an inner electronic assembly that includes electronic circuitry for interfacing with the sensing element and communicating the data to the external unit"). In addition Goldshtein teaches the inner electronics in the housing component includes an ASIC. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the implantable measurement device taught by Nunez with an electronics housing component coupled to the first anchoring component and the second anchoring component, the electronics housing component configured to extend between the first and second anchoring components for the predictable purpose of miniaturizing the IMD by placing the electronics for receiving and transmitting the sensor measurements in the electronics housing taught by Goldshtein. For clarification, it is also notoriously known that wireless sensors reduce or otherwise minimize the additional risk associated with sensor-based monitoring of cardiac health after surgery and/or after implantation of a cardiac device, see for example "US 20130144379 to Najafi et al., para. 0004 "Wired sensors, however, require passage of wires through cutaneous layers, thereby risking physical injury and infection. Wireless sensors are hence more desirable for such biological operation. Implantation of sensors, however, is an invasive procedure by itself, which elevates and contributes to the risk faced by the patient. There is hence a need for sensors and sensor systems that reduce or otherwise minimize the additional risk associated with sensor-based monitoring of cardiac health after surgery and/or after implantation of a cardiac device .").
Nunez as modified does not specifically disclose at least one of the first and second anchoring components comprises a membrane configured to be opened, fenestrated, punctured, traversed or crossed via an interventional or noninvasive procedure and wherein, in the deployed configuration both the first anchoring component and the second anchoring component are defined by a frame including an outer edge member, a central portion, and a plurality of circumferentially spaced apart radial members that extend radially between the outer edge member and the central portion to define a plurality of open spaces extending an entire distance between the outer edge member and the central portion, and wherein the outer edge member, the central portion, and the plurality of radial members comprise the same material. Burg teaches a similar anchor device that having a frame including an outer edge member ([FIG1] outer rim 21), a central portion ([FIG1] hub 16), and a plurality of circumferentially spaced apart radial members that extend radially between the outer edge member and the central portion ([FIG2] frame structure elements 22, 14) with open spaces extending between the outer edge and the central portion ([FIG1] elements 22 have open areas between them), wherein the frame components are all the same material ([Col. 5 lines 47-60] the frame is nitinol) and the anchor component comprises a membrane configured to be punctured ([Col. 8 Lines 1-6] the hub has a gasket that is self-sealing and allows guide wires to pass). Therefore it would have been obvious to one of ordinary skill in the art at the time of filing to combine the device of Nunez with the frame of Burg in order to allow for access through the anchor for later procedures ([Col. 8 Lines 1-6]).
In regards to claims 6, 23 and 26, Goldshtein teaches the second sensing element is substantially flat against the inner wall (Claim 6), at least one of the first and second sensing elements is substantially flush with a corresponding first or second anchoring component (Claim 23) and the first and second sensing elements are substantially flush with the first and second anchoring components, respectively (Claim 26)(see entire document, for example para. 0009 "the gripping sleeve is in said gripping form, said first proximal surface and said second proximal surface are formed as nested conic structures extending proximally away from said proximal edge, or formed as parallel flat structures, separated by said proximal edge; or/and said first distal surface and said second distal surface are formed as nested conic structures extending distally away from said distal edge, or formed as parallel flat structures, separated by said distal edge.").
In regards to claims 7, 8, 9, 12, 27 and 41, Burg teaches biocompatible material disposed over at least a portion of a surface of a sensing element and anchoring element to promote tissue ingrowth ([Col. 7 Lines 41-56]). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the implantable measurement device taught by Nunez in view of Goldshtein with a first layer of a biocompatible material disposed over at least a portion of a surface of the first sensing element and the first anchoring element to promote tissue ingrowth, and a second layer of the biocompatible material disposed over at least a portion of a surface of the second sensing element and the second anchoring element to promote tissue ingrowth taught by Chavan for the predictable purpose of making the sensing element and anchoring element a more integral part of the body.
In regards to claim 19, Goldshtein teaches a memory unit configured to store data received from at least one of the first and second sensing elements (see entire document, for example para. 0075 "memory for storing instructions or/and data. Alternatively or additionally, optionally, the data processor includes a non-volatile storage, for example, a magnetic hard-disk or/and removable media, for storing instructions or/and data.").
In regards to claim 28, Nunez modified discloses the essential features of the claimed invention, except for explicitly teaching the first and second sensing elements are aligned with respect to each other. It appears the device of Nunez modified would operate equally well regardless of the alignment of the sensors which would range from 0-180 degrees. Further, applicant has not disclosed that the alignment claimed solves any stated problem or is for any particular purpose, indicating simply that the sensors may be aligned (see published Specification, para. 0189). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Nunez modified to have aligned sensors because it appears to be an arbitrary design consideration which fails to patentably distinguish over Nunez modified.
In regards to claim 39, Goldshtein teaches at least one of the first and second sensing elements is configured to perform temperature measurements after introducing inhalation of a bolus of cold air into lungs of a patient (see entire document, for example para. 0102 "temperature"). For clarification, the further limitation of "after introducing inhalation of a bolus of cold air into lungs of a patient" is considered intended use and not afforded patentable weight for the device claims.
In regards to claim 43, Burg teaches the first and second anchoring elements are made from a fluoropolymer membrane and nitinol ([Col. 7 Lines 41-56] fluoropolymer PTFE is used as the membrane and [Col. 5 lines 47-60] the frame is nitinol).
In regards to claims 73 and 74, Burg teaches that the outer edge member, the central portion and the plurality of radial members comprise metal, specifically nitinol ([Col. 5 Lines 47-60][Col. 12 Lines 38-45]).
Claim(s) 68-71 are rejected under 35 U.S.C. 103 as being unpatentable over US20090024042 to Nunez et al. (Nunez) in view of US20180098772 to Goldshtein et al. (Goldshtein) and US7128073 to van der Burg et al. (Burg) further in view of US20200069426 to Conklin et al. (Conklin).
In regards to claim 68, Nunez as modified in claim 1 does not specifically disclose that the open spaces can pass a catheter or instrument. Conklin teaches a similar cardiac anchor where at least some of the openings defined by the frames of both the first anchoring component and the second anchoring component are sufficiently large to allow a puncture device and a catheter to pass therethrough during the interventional procedure ([¶243-247,581-582] the openings, as defined as the distance between the center 294 and the edge 295, can pass a puncture device or a catheter as the distance is 10-20mm). Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to combine Nunez with the teachings of Conklin to have a membrane large enough to pass surgical instruments ([¶581-583]).
In regard to claim 69, Conklin teaches at least some of the openings defined by the frames of both the first anchoring component and the second anchoring component are sufficiently large to allow a 24 Fr catheter to pass therethrough ([¶243-247,581-582] the openings, as defined as the distance between the center 294 and the edge 295, can pass a puncture device or a catheter as the distance is 10-20mm. A 24 Fr catheter is 8mm in diameter).
In regard to claim 70, Conklin teaches all of the openings defined by the frames of both the first anchoring component and the second anchoring component are sufficiently large to allow the puncture device and the catheter to pass therethrough during the interventional procedure ([¶243-247,581-582] the openings, as defined as the distance between the center 294 and the edge 295, can pass a puncture device or a catheter as the distance is 10-20mm).
In regard to claim 71, Burg teaches the frames of both the first anchoring component and the second anchoring component include up to five radial members ([FIG1]).
Claims 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over US20090024042 to Nunez et al. (Nunez) in view of US20180098772 to Goldshtein et al. (Goldshtein) and US7128073 to van der Burg et al. and further in view of US20170105711 to Masters (Masters).
In regards to Claim 10, Nunez modified teaches the essential features of the claimed invention, except for explicitly teaching the film comprises at least one feature configured to reduce tensile stress on the second sensing element. Masters teaches such limitation (see entire document, for example para. 0127 and 0139 and 0170) for the purpose improving the hemocompatibility of the wire without substantially changing its mechanical characteristics. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the implantable measurement device taught by Nunez modified with at least one feature configured to reduce tensile stress on the second sensing element taught by Masters for the predictable purpose of improving the hemocompatibility of the wire without substantially changing its mechanical characteristics.
In regards to Claim 11, Masters teaches the implantable measurement device comprises non-distensible rings, sections of high distensibility, or non- distensible rings and sections of high distensibility (see entire document, for example Fig. 2A and para. 0096).
Claims 13-18 are rejected under 35 U.S.C. 103 as being unpatentable over US20090024042 to Nunez et al. (Nunez) in view of US20180098772 to Goldshtein et al. (Goldshtein) and US7128073 to van der Burg et al. and further in view of US20090030331 to Hochareon et al. (Hochareon).
In regards to Claims 13-18, Nunez modified teaches the essential features of the claimed invention, except for one or more remote sensing elements coupled to an anchor by a sensing tether (Claims 13-15). Hochareon teaches one or more remote sensing elements coupled to an anchor by a sensing tether for the purpose of having additional sensors comprising a pressure sensor, a blood chemistry sensor, a blood gas sensor used to monitor for heart failure, progression of emphysema or pulmonary embolism (see entire document, for example para.0018, 0020). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the implantable measurement device taught by Nunez in view of Goldshtein to have remote sensing elements coupled to an anchor by a sensing tether for the purpose of having additional sensors comprising a pressure sensor, a blood chemistry sensor, a blood gas sensor used to monitor for heart failure, progression of emphysema or pulmonary embolism.
Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over US20090024042 to Nunez et al. (Nunez) in view of US20180098772 to Goldshtein et al. (Goldshtein) and US7128073 to van der Burg et al. and further in view of US 20180126179 to Haasi et al. (Haasi).
In regards to Claim 32, Nunez modified teaches the essential features of the claimed invention, except for at least one reinforcement strut connecting the electronics housing to at least one of the first and second anchoring component. Haasi teaches the use of at least one reinforcement strut connecting the electronics housing to at least one of the first and second anchoring component for the purpose of engaging the patient's heart and to secure the expandable anchoring member and the housing to the patient's heart (see entire document, for example para. 0006, 0009, 0019, 0023, 0080 and 0092, struts 40). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the implantable measurement device taught by Nunez in view of Goldshtein to include at least one reinforcement strut connecting the electronics housing to at least one of the first and second anchoring component taught by Haasi for the predictable purpose of engaging the patient's heart and to secure the expandable anchoring member and the housing to the patient's heart
Claims 33-36 are rejected under 35 U.S.C. 103 as being unpatentable over US20090024042 to Nunez et al. (Nunez) in view of US20180098772 to Goldshtein et al. (Goldshtein) and US7128073 to van der Burg et al. and further in view of US20170358942 to Pugh et al. (Pugh).
In regards to Claims 33-36, Nunez in view of Goldshtein teach the essential features of the claimed invention, except for the electronics housing component includes a battery and an antenna configured to relay measurement data from the first and second sensing elements (Claim 33); the antenna defines a periphery of the at least one of the first and second anchoring components (Claim 34); and the antenna is configured to transmit measurement data to an external monitoring system (Claim 36). Pugh teaches such limitations for the purpose of monitoring physiological measurement and recharging the implant device (see entire document, for example para. 0001, 0004, 0006, 0011, 0049, 0056, 0058, 0066, 0072, 0147 and 0151, antenna 435 and energization elements 530 situated on the periphery send and receive signal and receive power wirelessly). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the implantable measurement device taught by Nunez in view of Goldshtein to include the electronics housing component includes a battery and an antenna configured to relay measurement data from the first and second sensing elements; an antenna defines a periphery of the at least one of the first and second anchoring components; and the antenna is configured to transmit measurement data to an external monitoring system taught by Pugh for the predictable purpose of monitoring physiological measurement and recharging the implant device.
Claims 46-48 are rejected under 35 U.S.C. 103 as being unpatentable over US20090024042 to Nunez et al. (Nunez) in view of US20180098772 to Goldshtein et al. (Goldshtein) and US7128073 to van der Burg et al. and further in view of US20130281988 to Magnon et al. (Magnon).
In regards to Claims 46-48, Nunez in view of Goldshtein teach the essential features of the claimed invention, except for the implantable measurement further comprising a therapeutic device, an occlude or a shunt. Magnon teaches such limitations for the purpose of providing therapy in response to the physiological measurement (see entire document, for example para. 0009 "Cardiac implants in the atrial septum have been used for many purposes. For example, septal occluders can be used for transcatheter closure of congenital heart defects, such as the atrial septal defects or the patent foramen ovale; and atrial shunt devices can be used to treat congestive heart failures by allowing a small volume of blood to travel from the left side of the heart to the right side of the heart, thereby reducing the left atrial pressure."). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the implantable measurement device taught by Nunez in view of Goldshtein to include a therapeutic device, an occlude or a shunt taught by Magnon for the predictable purpose of providing therapy in response to the physiological measurement.
Claim 50 is rejected under 35 U.S.C. 103 as being unpatentable over US20090024042 to Nunez et al. (Nunez) in view of US20180098772 to Goldshtein et al. (Goldshtein) and US7128073 to van der Burg et al. and further in view of US 7236821 to Cates et al. (Cates).
In regards to Claim 50, Nunez in view of Goldshtein teach the essential features of the claimed invention, except for the sensing elements are piezocapacitive sensors. Cates teaches sensing elements in cardiac implants are piezocapacitive sensors ([C13 L25-31] piezo elements are used to measure pressure). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to implement the implantable measurement device taught by Nunez in view of Goldshtein with piezocapacitive sensors taught by Cates for the predictable purpose of monitoring hemodynamic parameters.
Response to Applicant's Amendments and Arguments
Applicant’s arguments, see pgs. 14-15, filed 12/12/25, with respect to the rejection(s) of claim(s) 1, 5-21, 23, 25-28, 32-39, 41-48, 50 and 68-72 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of van de Burg.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 MICHAEL ANTHONY CATINA whose telephone number is (571)270-5951. The examiner can normally be reached 10-6pm.
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/MICHAEL A CATINA/Examiner, Art Unit 3791 /TSE W CHEN/Supervisory Patent Examiner, Art Unit 3791
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