DETAILED ACTION
Applicant' s arguments, filed 03/10/2026 have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 08/04/2023, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 1-11, 13-16, and 19-20 are the current claims hereby under examination.
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 Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
a first anchor structure in claims 1 and 20
a second anchor structure in claims 1 and 20
a first anchor arm of claim 11
a second anchor arm of claim 11
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
a first anchor structure /arm of claims 1 and 11 are interpreted as the corresponding structure described in the specification in at least paragraphs 0100-0101 and Fig. 9-1 reference 94 and its equivalents
a second anchor structure /arm of claims 1 and 11 are interpreted as the corresponding structure described in the specification in at least paragraphs 0100-0103 and Fig. 9-1 reference 95 and its equivalents
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112(b)
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.
Claims 5 and 20 are 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.
Claim 5 recites “the anchor arm including a proximal bowed portion that bows out in a direction of the axis and a distal tissue-contact pad” but it is unclear what reference is being used to determine the proximal and distal parts of the anchor arm. For the purposes of this examination, the limitation is interpreted as proximal/distal with respect to the fluid conduit.
Claim 20 recites “a method of manufacturing a shunt implant device” in line 1. However the newly added limitations of lines 10-15 are drawn towards the deployment and anchoring of the shunt. It is unclear how these limitations relate to the method of manufacturing a shunt. It is unclear how the deployment of the shunt may be considered part of the manufacturing method of the shunt. For the purposes of this examination, the limitations will be interpreted as the intended use of the manufactured shunt.
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.
Claims 1-2, 5, 7-11, 13-15, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Taft US Patent Application Publication Number US 2017/0106176 A1 hereinafter Taft in view of Minor US Patent Application Publication Number US 2020/0196876 A1 hereinafter Minor in view of Najafi US Patent Application Publication Number US 2019/0269339 A1 hereinafter Najafi further in view of Vecchio US Patent Application Publication Number US 2020/0197178 A1 hereinafter Vecchio
Regarding claim 1, Taft discloses an implant device (Abstract) comprising:
a shunt body that forms a fluid conduit having a channel axis (Paragraph 0068: central flow tube; Figs. 6A-B reference 166);
a first anchor structure associated with a first end of the shunt body and configured to deflect away from the channel axis in a deployed configuration (Paragraphs 0066-0067: first proximal flange; Figs. 6A-B reference 154a);
a second anchor structure associated with a second end of the shunt body and configured to deflect away from the channel axis in a deployed configuration (Paragraph 0067: opposing flange; Figs. 6A-B reference 152a);
Taft fails to further disclose the implant being a sensor implant and including a sensor device coupled to the first anchor structure; and an antenna assembly including a coil antenna disposed in a cylindrical housing, the antenna assembly being coupled to the second anchor structure, the coil antenna having a coil axis that is angled relative to the channel axis; and a wire connector connected between the sensor device and the antenna assembly, the wire connector passing through the fluid conduit.
Minor teaches an implantable measurement device is disclosed which includes a first anchoring component which engages a first inner wall defining a first chamber of a heart, a first sensing element which performs physiologic measurements in the first chamber, and a second sensing element which performs physiologic measurements in the second chamber (Abstract). Thus, Minor falls within the same field of endeavor as Applicant’s invention.
Minor teaches a sensor implant and including a sensor device coupled to the first anchor structure; and an antenna assembly including a coil antenna the antenna assembly being coupled to the second anchor structure, the coil antenna having a coil axis and a wire connector connected between the sensor device and the antenna assembly (Paragraphs 0146-0148: the measurement device may include a sensing element on each side of the anchor structure. The anchor structure including two anchoring discs. One side of the sensing device includes the electronics including the antenna coil and power storage. The opposite side may include only the sensor which is powered by the coil and/or battery located on the other side of the anchoring structure; Figs. 11-13 references 8, 9, 37, and 38. The wire illustrated in Fig.12 which appears to connect reference 37 to 38 and provide power to the sensing element 31; Paragraph 0152: the measurement device may be implemented as a shunt).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to incorporate the sensing system having a coil antenna and electronics on one side and a sensor on the other side connected by a wire to power the sensor as taught by Minor into the device of Taft because incorporating a sensor and means to communicate with said sensor allows a physician to monitor certain parameters around the shunt such as pressure or flow to determine if the shunt is working as desired and provide insight into the patient’s condition and how it may be progressing. It is further noted that the above combination of Taft in view of Minor is considered to teach the limitation of “a wire connector connected between the sensor device and the antenna assembly, the wire connector passing through the fluid conduit” because Minor teaches a wire connecting each side of the sensing system and that the sensing system may be implemented into a shunt (Fig. 12 the wire; Paragraphs 0147 and 0152: the sensor on the opposite side of the electronics may be powered by the battery/antenna coil on the opposite side. The measurement device may be implemented as a shunt) which is considered to at least suggest that the wire to connect one side of the sensing system to the other may pass through the shunt lumen since there is no recitation of creating a separate puncture point to pass the wire through and the creating of such a separate puncture point may negatively affect the patient by reducing the integrity of the tissue.
Taft in view of Minor fails to further teach the device wherein the coil antenna is disposed in a cylindrical housing and the coil antenna having a coil axis that is angled relative to the channel axis
Najafi teaches wireless implants and systems and methods that employ such implants to monitor multiple physiological parameters within living bodies, such as monitoring cardiovascular pressures/hemodynamics (Abstract). Thus Najafi falls within the same field of endeavor as Applicant’s invention.
Najafi teaches a system having two cylindrically-shaped housing being secured to each other by a tether which allows the housings to have off axis movement from each other through the flexible connection (Paragraph 0038; Fig. 5). The sensor system include an antenna wrapped around a core, a battery, and sensing circuitry (Paragraph 0031). The two housings may share one or more internal components. A single antenna may be present in one of the housings that is shared by the sensing circuitry of both housings (Paragraph 0034).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to configure the sensor housings of Taft in view of Minor to be cylindrically shaped and have the connection therebetween to be flexible as taught by Najafi because the cylindrical shape may provide the maximum amount of internal space for componentry while maintaining a size suitable for navigating the implantable circuit through blood vessels. The flexible connection between the housings also provides greater degrees of freedom for positioning the housings in the deployed configuration and during deployment. Additionally, the particular size and shape of the housing may be a matter of routine optimization and experimentation to configure the system to conform to a particular desired use case.
Taft in view of Minor further in view of Najafi fails to further teach the device wherein the coil antenna having a coil axis that is angled relative to the channel axis.
Vecchio teaches an implantable medical device, in which the implantable medical device includes a fluid shunt extending through a wall separating a first cavity and a second cavity within the heart. The fluid shunt includes a first portion adapted to extend into the first cavity within the heart, a second portion adapted to extend into the second cavity within the heart, and an intermediate portion interconnecting the first and second portions (Abstract). Thus, Vecchio falls within the same field of endeavor as Applicant’s invention.
Vecchio teaches an instrumented shunt having retaining members and sensor attached thereto. Vecchio teaches that sensors may be attached to the support members (Paragraph 0113; Figs. 12-13 and 18-20 references 220 and 222). Vecchio appears to at least suggest that sensors are attached longitudinally to the support structures as the longitudinal axis of the sensors 220 and 222 in the cited figures align with the strut to which they are attached.
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to axially attach the cylindrical housings of the sensors and circuitry components as taught by Minor in view of Najafi to the anchor structures of the shunt of Taft based on the teachings of Vecchio because such axial attachment provides a larger contact region between the housings and the strut which may improve the bonding strength between the two. Additionally, having the longitudinal axes of the housings aligned with the longitudinal direction of the support strut reduces the overall bulk of the implant since the sensor and circuitry housings are not protruding as far as they would otherwise be if oriented with their longitudinal axis parallel to the lumen axis. The lower bulk may improve patient outcomes by eliminating protrusions from the device which may serve as locations for complications to arise such as blood clotting .
Examiner’s Note: All dependent claims will be rejected with the understanding that Taft in view of Minor in view of Najafi further in view of Vecchio teaches the shunt of Taft with an antenna and sensor attached to support structures on opposite sides of the shunt.
Regarding claim 11, Taft discloses an implant device (Abstract) comprising:
a tubular frame that defines a fluid channel having a channel axis (Paragraph 0068: central flow tube; Figs. 6A-B reference 166);
a first anchor arm associated with a first end of the tubular frame the first anchor arm being configured to deflect away from the channel axis (Paragraphs 0066-0067: first proximal flange; Figs. 6A-B reference 154a);
a second anchor arm associated with a second end of the tubular frame the second anchor arm being configured to deflect away from the channel axis (Paragraph 0067: opposing flange; Figs. 6A-B reference 152a);
Taft fails to further disclose the implant being a sensor implant and including a sensor device coupled to the first anchor arm at a first position wholly outside of the fluid channel; and an antenna coupled to the second anchor arm at a second position wholly outside of the fluid channel; and a connector attached to the sensor device and the antenna and passing through the fluid channel defined by the tubular frame from the first end of the tubular frame to the second end of the tubular frame.
Minor teaches a sensor implant and including a sensor device coupled to the first anchor arm at a first position; and an antenna coupled to the second anchor arm at a second position; and a connector attached to the sensor device and the antenna and passing through the implanted device. (Paragraphs 0146-0148: the measurement device may include a sensing element on each side of the anchor structure. The anchor structure including two anchoring discs. One side of the sensing device includes the electronics including the antenna coil and power storage. The opposite side may include only the sensor which is powered by the coil and/or battery located on the other side of the anchoring structure; Figs. 11-13 references 8, 9, 37, and 38. The wire illustrated in Fig.12 which appears to connect reference 37 to 38 and provide power to the sensing element 31; Paragraph 0152: the measurement device may be implemented as a shunt).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to incorporate the sensing system having a coil antenna and electronics on one side and a sensor on the other side connected by a wire to power the sensor as taught by Minor into the device of Taft because incorporating a sensor and means to communicate with said sensor allows a physician to monitor certain parameters around the shunt such as pressure or flow to determine if the shunt is working as desired and provide insight into the patient’s condition and how it may be progressing. It is further noted that the above combination of Taft in view of Minor is considered to teach the limitation of “a connector attached to the sensor device and the antenna and passing through the fluid channel defined by the tubular frame from the first end of the tubular frame to the second end of the tubular frame” because Minor teaches a wire connecting each side of the sensing system and that the sensing system may be implemented into a shunt (Fig. 12 the wire; Paragraphs 0147 and 0152: the sensor on the opposite side of the electronics may be powered by the battery/antenna coil on the opposite side. The measurement device may be implemented as a shunt) which is considered to at least suggest that the wire to connect one side of the sensing system to the other may pass through the shunt lumen since there is no recitation of creating a separate puncture point to pass the wire through and the creating of such a separate puncture point may negatively affect the patient by reducing the integrity of the tissue.
Taft in view of Minor fails to further disclose the sensor device and antenna being coupled at respective first and second positions wholly outside of the fluid channel.
Najafi teaches a system having two cylindrically-shaped housing being secured to each other by a tether which allows the housings to have off axis movement from each other through the flexible connection (Paragraph 0038; Fig. 5). The sensor system include an antenna wrapped around a core, a battery, and sensing circuitry (Paragraph 0031). The two housings may share one or more internal components. A single antenna may be present in one of the housings that is shared by the sensing circuitry of both housings (Paragraph 0034).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to configure the sensor housings of Taft in view of Minor to be cylindrically shaped and have the connection therebetween to be flexible as taught by Najafi because the cylindrical shape may provide the maximum amount of internal space for componentry while maintaining a size suitable for navigating the implantable circuit through blood vessels. The flexible connection between the housings also provides greater degrees of freedom for positioning the housings in the deployed configuration and during deployment. Additionally, the particular size and shape of the housing may be a matter of routine optimization and experimentation to configure the system to conform to a particular desired use case.
Taft fails to further disclose the sensor device and antenna being coupled at respective first and second positions wholly outside of the fluid channel.
Vecchio teaches an instrumented shunt having retaining members and sensor attached thereto. Vecchio teaches that sensors may be attached to the support members (Paragraph 0113; Figs. 12-13 and 18-20 references 220 and 222). Vecchio appears to at least suggest that sensors are attached longitudinally to the support structures as the longitudinal axis of the sensors 220 and 222 in the cited figures align with the strut to which they are attached.
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to axially attach the cylindrical housings of the sensors and circuitry components as taught by Minor in view of Najafi to the anchor structures of the shunt of Taft based on the teachings of Vecchio because such axial attachment provides a larger contact region between the housings and the strut which may improve the bonding strength between the two. Additionally, having the longitudinal axes of the housings aligned with the longitudinal direction of the support strut reduces the overall bulk of the implant since the sensor and circuitry housings are not protruding as far as they would otherwise be if oriented with their longitudinal axis parallel to the lumen axis. The lower bulk may improve patient outcomes by eliminating protrusions from the device which may serve as locations for complications to arise such as blood clotting .
Examiner’s Note: All dependent claims will be rejected with the understanding that Taft in view of Minor in view of Najafi further in view of Vecchio teaches the shunt of Taft with an antenna and sensor attached to support structures on opposite sides of the shunt.
Regarding claim 2, modified Taft teaches the sensor implant device of claim 1. Modified Taft fails to further teach the device further comprising a control circuit chip disposed in the cylindrical housing and electrically coupled to the coil antenna.
Minor teaches a control circuit chip disposed in the cylindrical housing and electrically coupled to the coil antenna (Paragraph 0147: control module; Fig. 12 references 33 and 35).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to include the control circuitry in the housing with the antenna as taught by Minor in the device of modified Taft because having the controller close the antenna and battery may reduce the overall size of the device since these elements could be structured to conform to each other and reduce the space needed in the housing. Additionally, the particular location of circuitry in one housing or the other is a mere rearrangement of parts and produces no surprising technical effect.
Regarding claim 5, modified Taft teaches the sensor implant device of claim 1. Modified Taft further teaches the device wherein the first anchor structure comprises an anchor arm configured to extend radially outward with respect to an axis of the fluid conduit the anchor arm including a proximal bowed portion that bows out in a direction of the axis and a distal tissue-contact pad (Paragraphs 0066-0067 and 0077: the first proximal flange and the terminal end; Figs. 6A-B references 154a illustrate the bowed flange which bows in the direction of the axis and extends away from the axis of the central lumen and the contact pad at the distal end thereof).
Taft fails to further teach the sensor device is coupled to the proximal bowed portion of the anchor arm.
Vecchio teaches an instrumented shunt having retaining members and sensor attached thereto. Vecchio teaches that sensors may be attached to the support members (Paragraph 0113; Figs. 12-13 and 18-20 references 220 and 222).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to attach the cylindrical housings of the sensors and circuitry components as taught by Minor in view of Najafi to the bowed portion of the anchor structures of the shunt of Taft based on the teachings of Vecchio because attaching the housings in this location is a mere rearrangement of parts and does not produce a surprising technical effect. It would seem that the housings may be attached to any portion of the support structure that prevents them from occluding the flow lumen with no surprising technical effect.
Regarding claim 7, modified Taft teaches the sensor implant device of claim 1. Modified Taft further teaches the device wherein the shunt body defines a flow channel that is angled with respect to a tissue-holding plane of the sensor implant device (Paragraph 0083: the angle between the reference plane and central flow tube; Figs. 6A-B illustrate the anchor members are angled with respect to the flow lumen. The tissue holding plane is approximately perpendicular to the flow direction; Fig. 6C references 174 and HP ).
Regarding claim 8, modified Taft teaches the sensor implant device of claim 1. Modified Taft further teaches the device wherein the first anchor structure and the second anchor structure are configured to hold a portion of a tissue wall therebetween in a tissue plane (Paragraphs 0066-0067: the flanges contact opposite sides of the tissue wall and this hold the tissue wall therebetween; Figs. 6A-B the space between flanges 152a and 154a).
Modified Taft fails to further disclose the device when the first anchor structure and the second anchor structure are holding the portion of the tissue wall, the portion of the tissue wall is disposed between the sensor device and the antenna assembly; and the coil axis of the coil antenna is substantially parallel with the tissue plane.
Taft in view of Minor in view of Najafi further in view of Vecchio as presented in the above rejection of claim 1 teaches that the antenna and sensor are on opposite sides of the tissue wall (Minor: Paragraphs 0146-0148: the measurement device may include a sensing element on each side of the anchor structure. The anchor structure including two anchoring discs. One side of the sensing device includes the electronics including the antenna coil and power storage. The opposite side may include only the sensor which is powered by the coil and/or battery located on the other side of the anchoring structure; Figs. 11-13 references 8, 9, 37, and 38. The wire illustrated in Fig.12 which appears to connect reference 37 to 38 and provide power to the sensing element 31; Paragraph 0152: the measurement device may be implemented as a shunt) and that the sensor housings may be attached to the support structure such that they are axially aligned with the length of the support structure, or substantially parallel to the tissue plane (Vecchio: Paragraph 0113; Figs. 12-13 and 18-20 references 220 and 222). Vecchio appears to at least suggest that sensors are attached longitudinally to the support structures as the longitudinal axis of the sensors 220 and 222 in the cited figures align with the strut to which they are attached).
Thus the limitations of “when the first anchor structure and the second anchor structure are holding the portion of the tissue wall, the portion of the tissue wall is disposed between the sensor device and the antenna assembly; and the coil axis of the coil antenna is substantially parallel with the tissue plane” are taught by the combination of Taft in view of Minor in view of Najafi further in view of Vecchio as presented in claim 1 above.
Regarding claims 9 and 13, modified Taft teaches the sensor implant device of claims 1 and 11. Modified Taft further teaches the device wherein, when the first anchor structure and the second anchor structure are projected radially outward with respect to an axis of the fluid conduit (Fig. 6A-B references 152a and b, and 154a and b The anchor structures are projected radially outward from the axis of the fluid conduit).
Modified Taft fails to further disclose the sensor device and the antenna assembly are both radially outside of an axial channel of the fluid conduit on a common radial side of the shunt body and wherein the connector axially traverses the tubular frame.
Vecchio teaches an instrumented shunt having retaining members and sensor attached thereto. Vecchio teaches that sensors may be attached to the support members (Paragraph 0113; Figs. 12-13 and 18-20 references 220 and 222).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to attach the cylindrical housings of the sensors and circuitry components as taught by Minor in view of Najafi to the anchor structures on a common radial side of the shunt of Taft based on the teachings of Vecchio because Vecchio teaches that the housings of the sensor and antenna may be attached to various locations on the shunt frame and attaching the antenna and sensor to a common axial side allows the connector therebetween (Minor: Paragraphs 0146-0148: The opposite side may include only the sensor which is powered by the coil and/or battery located on the other side of the anchoring structure; Figs. 11-13 references 8, 9, 37, and 38. The wire illustrated in Fig.12) to axially cross flow channel thereby presenting a smaller cross section and disrupting flow through the lumen less than if the antenna and sensor were to be connected on opposite radial sides which would necessitate the wire crossing the flow channel perpendicularly in addition to traversing it axially. Such a perpendicular crossing would cause more substantially flow disruption and/or would necessitate more complex wire arrangement to prevent flow such flow disruption. Additionally, the particular placement of sensor and antenna housings is considered a matter of routine optimization and experimentation. Minor teaches that the housings may be present on opposite sides of the sunt and Vecchio teaches that the housings may be attached to the support frame. The particular location of their attachment, the means by which they are attached, and/or the orientation of their attachment are all matters of routine optimization and experimentation to configure the instrumented device to have a desired form factor or profile during or after deployment. The particular location, orientation, and attachment means do not produce a surprising technical effect.
Regarding claims 10 and 19, modified Taft teaches the sensor implant device of claims 9 and 11. Modified Taft further teaches the device wherein, when the first anchor structure and the second anchor structure are projected axially with respect to the axis of the fluid conduit in a delivery configuration within a delivery catheter of the sensor implant device (Paragraph 0098; Figs. 9A-D The support arms extend int the same axial direction as the fluid conduit for delivery; Paragraph 0062: the delivery catheter; Fig. 3M references 50 and 150: the catheter and the shunt),
Modified Taft further teaches that the shunt is in a substantially tubular shape when in a delivery configuration and that the anchor structures are arranged axially with the flow lumen (Paragraph 0098 and Figs. 9A-D)
Modified Taft fails to further disclose the sensor device and the antenna assembly are within the axial channel of the fluid conduit and within a profile of the tubular frame in a deployment configuration.
Vecchio teaches an instrumented shunt having retaining members and sensor attached thereto. Vecchio teaches that sensors may be attached to the support members (Paragraph 0113; Figs. 12-13 and 18-20 references 220 and 222). Vecchio further teaches that the device fits within a substantially tubular profile in a deployment configuration (Paragraph 0115; Fig. 16). Vecchio further illustrates the attached sensors facing outwards in a deployed configuration (Fig. 20 references 222)
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to configure the invention of modified Taft such that the sensor and antenna assembly are attached to the inside of the anchoring members and thus within the fluid conduit in a deployment configuration because such positioning of the sensor and antenna would prove the shunt with a smaller deployment profile which allows for a smaller and less intrusive delivery mechanism. The shunt may then expand and/or be deployed into a desired configuration upon introduction to the shunt site where the sensor and antenna are moved substantially out of the flow path to prevent flow restriction, and their location on the inside of the shunt during deployment positions the housings to be facing outwards and thus not interfering with the anchor arms attachment to the tissue wall and preventing the tissue from interfering with sensor readings by blocking sensing windows.
Regarding claim 14, modified Taft teaches the sensor implant device of claim 13. Modified Taft fails to further teach the device wherein the connector runs inside the tubular frame between the first end and the second end.
Minor teaches a wire connecting the housing with the antenna to the housing with the sensor (Figs. 11-12: the wire pictured in Fig. 12 connecting the two housings; Paragraphs 0146-0148: the sensor may be powered from the other housing)
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to configure Taft in view of Minor in view of Najafi further in view of Vecchio to have the connector run inside of the tubular frame between the first and second ends in order to connect the sensor and the antenna because Minor teaches the presence of such a connector running through the implanted device and incorporating the sensor and antenna of Minor into the shunt of Taft necessitates the connector traversing the tissue between the sensor and antenna. Running the connector outside of the tubular frame would make the connector contact the patient’s tissue which could potentially cause irritation or other undesirable interactions. Running the connector through the lumen of the device provides minimal flow disruption and prevents the connector from contacting the patient tissue which may improve patient outcomes.
Regarding claim 15, modified Taft teaches the sensor implant device of claim 11. Modified Taft fails to further teach the device wherein the antenna comprises a conductive coil.
Minor teaches the antenna being a coil antenna (Paragraph 0146).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to implement the coil type antenna of Minor into the device of modified Taft because such an antenna allows for wireless communication and power transfer to communicate the collected sensor data as well as provide power to operate the implanted sensor (Minor: Paragraphs 0145-0146)
Claims 3-4 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Taft US Patent Application Publication Number US 2017/0106176 A1 hereinafter Taft in view of Minor US Patent Application Publication Number US 2020/0196876 A1 hereinafter Minor in view of Najafi US Patent Application Publication Number US 2019/0269339 A1 hereinafter Najafi in view of Vecchio US Patent Application Publication Number US 2020/0197178 A1 hereinafter Vecchio as applied to claims 1 and 11 above and further in view of Massoud US Patent Application Publication Number US 2009/0182206 A1 hereinafter Massoud
Regarding claims 3, 4, and 16 modified Taft teaches the sensor implant device of claims 1 and 15. Modified Taft fails to further teach the device wherein coil antenna has an axial length that is at least twice as great as a diameter of the coil antenna, and wherein coil antenna is wrapped around a magnetic core.
Massoud teaches a system for monitoring blood pressure and other physiologic parameters (Abstract). Thus, Massoud is reasonably pertinent to the problem at hand.
Massoud teaches that a receiver coil may have a large number of possible geometries. The coil conductor may be wound around a ferrite core to enhance magnetic properties and may be formed into a long and skinny or short and wide cylindrical solenoid (Paragraph 0035).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to configure the antenna of modified Taft as a long and skinny antenna wrapped around a ferrite core as taught by Massoud because Massoud teaches that a ferrite core may improve the magnetic properties of the antenna and that the particular configuration of an antenna is subject to routine optimization and experimentation based on the desired use case. Thus the antenna being at least twice as long as its diameter is considered a matter of routine optimization and experimentation to configure the form factor of the antenna to fit the particular use case with no surprising technical effect.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Taft US Patent Application Publication Number US 2017/0106176 A1 hereinafter Taft in view of Minor US Patent Application Publication Number US 2020/0196876 A1hereinafter Minor in view of Najafi US Patent Application Publication Number US 2019/0269339 A1 hereinafter Najafi in view of Vecchio US Patent Application Publication Number US 2020/0197178 A1 hereinafter Vecchio as applied to claim 5 above and further in view of Eigler US Patent Number US 11234702 B1 hereinafter Eigler
Regarding claim 6, modified Taft teaches the sensor implant device of claim 5. Modified Taft fails to further teach the device wherein the sensor device includes a sensor transducer including a sensor membrane that faces in a direction within 30° of the axis of the fluid conduit.
Eigler teaches interatrial shunts having incorporated physiologic sensors for monitoring and treating cardiovascular syndromes, including heart failure and pulmonary hypertension (Abstract). Thus, Eigler falls within the same field of endeavor as Applicant’s invention.
Eigler teaches a sensor which may include a sensing diaphragm, or membrane, connected to the shunt frame and where the sensing surface may be aligned with the axis of the fluid conduit. Eigler teaches that the sensor may be positioned in any suitable location within the shunt. (Col 55 lines 9-46; Figs 31A-C reference 3104’ The sensor diaphragm is depicted as substantially aligned with the axis of the fluid conduit)
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to configure the sensor of modified Taft to include a sensor membrane that faces a direction within 30 degrees of the fluid conduit as taught by Eigler because Eigler teaches that pressure sensing diaphragms are well suited for use in shunts and thus the incorporation of a sensor with a sensor membrane is a simple substitution of one known element (a generic pressure sensor of Minor paragraph 0196) for another (a sensor with a membrane as taught by Eigler) with no surprising technical effect. Similarly, the precise angle of the sensor faces and/or the location of the sensing membrane on the housing, with respect to the fluid conduit is a matter of routine optimization and experimentation and/or a mere rearrangement of parts and does not produce a surprising technical effect.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Taft US Patent Application Publication Number US 2017/0106176 A1 hereinafter Taft in view of Minor US Patent Application Publication Number US 2020/0196876 A1hereinafter Minor
Regarding claim 20, Taft discloses a method of manufacturing a shunt implant device, the method comprising:
providing a shunt structure including a shunt body configured to form a tubular conduit, a first anchor structure associated with a first axial end of the shunt body, and a second anchor structure associated with a second axial end of the shunt body (Paragraphs 0066-0068: first proximal flange; Figs. 6A-B references 152a, 154a, 166: the shunt body forms a tubular conduit for blood flow and multiple anchor structures; Paragraph 0098: the shunt may be formed using lasers); deploying the shunt body through a wall separating a left atrium from a coronary sinus (Figs. 3O-V: deploying the shunt between the coronary sinus and left atrium )
Taft fails to further disclose the method including coupling a sensor device to the first anchor structure; coupling an antenna to the second anchor structure; running a connector wire through the tubular conduit of the shunt body between the sensor device and the antenna; anchoring the first anchor structure within the left atrium against such that the sensor device is positioned within the left atrium; and anchoring the second anchor structure within the coronary sinus such that the antenna is positioned within the coronary sinus.
Minor teaches a sensor implant and including a sensor device coupled to the first anchor arm at a first position; and an antenna coupled to the second anchor arm at a second position; and a connector attached to the sensor device and the antenna and passing through the implanted device. (Paragraphs 0146-0148: the measurement device may include a sensing element on each side of the anchor structure. The anchor structure including two anchoring discs. One side of the sensing device includes the electronics including the antenna coil and power storage. The opposite side may include only the sensor which is powered by the coil and/or battery located on the other side of the anchoring structure; Figs. 11-13 references 8, 9, 37, and 38. The wire illustrated in Fig.12 which appears to connect reference 37 to 38 and provide power to the sensing element 31; Paragraph 0152: the measurement device may be implemented as a shunt).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to incorporate the sensing system having a coil antenna and electronics on one side and a sensor on the other side connected by a wire to power the sensor as taught by Minor into the device of Taft because incorporating a sensor and means to communicate with said sensor allows a physician to monitor certain parameters around the shunt such as pressure or flow to determine if the shunt is working as desired and provide insight into the patient’s condition and how it may be progressing. It is further noted that the above combination of Taft in view of Minor is considered to teach the limitation of “running a connector wire through the tubular conduit of the shunt body between the sensor device and the antenna” because Minor teaches a wire connecting each side of the sensing system and that the sensing system may be implemented into a shunt (Fig. 12 the wire; Paragraphs 0147 and 0152: the sensor on the opposite side of the electronics may be powered by the battery/antenna coil on the opposite side. The measurement device may be implemented as a shunt) which is considered to at least suggest that the wire to connect one side of the sensing system to the other may pass through the shunt lumen since there is no recitation of creating a separate puncture point to pass the wire through and the creating of such a separate puncture point may negatively affect the patient by reducing the integrity of the tissue.
Taft in view of Minor teaches the shunt anchored between the coronary sinus and the left atrium and the presence of a sensor and antenna system attached to the shunt. Taft in view of Minor does not explicitly teach that method comprising: anchoring the first anchor structure within the left atrium against such that the sensor device is positioned within the left atrium; and anchoring the second anchor structure within the coronary sinus such that the antenna is positioned within the coronary sinus.
An obvious variation of Taft in view of Minor would be to anchor the first anchor structure within the left atrium against such that the sensor device is positioned within the left atrium; and anchor the second anchor structure within the coronary sinus such that the antenna is positioned within the coronary sinus. Such a configuration is obvious because there are a finite number of possible configurations of Taft in view of Minor and it would be obvious to try. In particular, the shunt of Taft in view of Minor may either be anchored such that the antenna is in the coronary sinus and the sensor is in the left atrium, or such that the antenna is in the left atrium and the sensor is in the coronary sinus. Both configurations have a reasonable expectation of success. As such, the particularly claimed positioning of the antenna and sensor are considered to be obvious in view of Taft as modified by Minor as presented above.
Response to Arguments
Applicant’s arguments with respect to claims 1, 11, and 20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 MATTHEW ERIC OGLES whose telephone number is (571)272-7313. The examiner can normally be reached M-F 8:00AM - 5:30PM.
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, Jason Sims can be reached on Monday-Friday from 9:00AM – 4:00PM at (571) 272 – 7540. 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.
/MATTHEW ERIC OGLES/Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791
Prosecution Insights