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 .
Information Disclosure Statement
The information disclosure statement filed May 19, 2023 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because only numbers but not the required additional information is provided, as indicated with such prior art being lined through in the attached signed IDS. It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
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: “energy receiving component configured to (a) receive energy from an energy source positioned external to the patient's body, and/or (b) generate energy when exposed to a magnetic or electric field generated by an energy source positioned external to the patient's body” in claims 59, 61-64, and 73 and “energy storage component configured to store energy received at and/or generated by the energy receiving component” in claims 63-64.
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.
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
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 65-70 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 65 recites the limitation "the first opening or the second opening" in line 12. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, these are considered “the first aperture and the second aperture” as such apertures are disclosed in line 5.
Claims 66-70 are rejected as dependents of claim 65.
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.
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) 51-52, 54-58, and 71-72 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nitzan et al. (US 2011/0306916), submitted in the August 4, 2025 IDS, in view of Keren (US 2018/0280667), submitted in the August 4, 2025 IDS, and further in view of Tai et al. (US 2016/0287101).
Regarding claim 51, Nitzan discloses a medical device configured to be implanted at a septal wall of a patient (see Fig. 6B, Abstract), the medical device comprising: an interatrial shunt having a frame (see Figs. 5A-6A; par. 91-92) and a first biocompatible membrane coupled to the frame (see par. 91, arms can be covered with tissue or PTFE membranes and Fig. 6B; par. 122-123), wherein the first biocompatible membrane defines a lumen extending therethrough (see Fig. 6B; par. 57, 123), and wherein the first biocompatible membrane is configured to extend between a left atrium and a right atrium of the patient when the frame is deployed across the septal wall of the patient such that the lumen fluidly connects the left atrium and the right atrium (see par. 11, 57, 90, 123).
Nitzan does not disclose a pressure sensing system having a pressure sensor.
Keren discloses an interatrial shunt placed between two chambers of the heart within the interatrial septum (see Fig. 1), between the right atrium and left atrium, the shunt comprising one or more pressure sensors used to measure the pressure in the subject’s right atrium and/or left atrium used to monitor progression of the treatment and ascertain the point in time at which the shunt may be removed from the patient, with one pressure sensor disposed on the proximal portion of the shunt and
pressure another on the distal portion, such that the pressure in both the left atrium and the right atrium is measured (see par. 62). Consequently, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to add a sensor to the proximal portion of the shunt and to the distal portion of the shunt, which would cause one to be in the right atrium and one in the left atrium such that pressure in both the left atrium and the right atrium is measured, as disclosed by Keren, to monitor progression of the treatment and ascertain the point in time at which the shunt may be removed from the patient.
Nitzan and Keren do not disclose a second biocompatible membrane at least partially encasing the pressure sensor, wherein the second biocompatible membrane resides on a single side of the septal wall in either the left atrium or the right atrium and is configured to be deflected based, at least in part, on a pressure in the respective left atrium or the right atrium.
Tai discloses biocompatible packaging for long term implantable sensors and electronics, wherein a pressure sensing system comprises a pressure sensor and a biocompatible membrane at least partially encasing the pressure sensor (see par. 30-32, 43, outer biocompatible membrane covering liquid covering pressure sensor, the membrane allowing for deflection to sense the environmental pressure) to protect against the conditions of the operational environment (see par. 30). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to replace each pressure sensor of Nitzan and Keren with one of Tai with a pressure sensing system that comprises a pressure sensor, biocompatible membrane, and liquid as disclosed by Tai that protects against the conditions of the operational environment. As each pressure sensor would be required to detect pressure in the left atrium or the right atrium due to the deflection of the membrane, one of ordinary skill would be motivated to place the pressure sensing system in an area that would detect pressure in the left atrium or the right atrium, and therefore to be placed on the shunt it would have to be securely placed on the shunt entirely in the right atrium or the left atrium. Consequently, it would reside on a single side of the septal wall in either the left atrium or the right atrium.
Regarding claim 52, Nitzan, Keren, and Tai disclose the limitations of claim 51 and as explained above, disclose the pressure sensing system is connected to the interatrial shunt (see rejection of claim 51 above, Keren discloses one pressure sensor disposed on the proximal portion of the shunt and pressure another on the distal portion, such that the pressure in both the left atrium and the right atrium is measured (see par. 62)).
Regarding claim 54, Nitzan, Keren, and Tai disclose the limitations of claim 51, and further disclose the pressure sensing system further comprises an enclosed cavity between the second biocompatible membrane and the pressure sensor (see Tai, par. 30-32, 43, outer biocompatible membrane covering liquid covering pressure sensor, the membrane allowing for deflection to sense the environmental pressure, liquid fills cavity that would be between biocompatible membrane and pressure sensor that would transmit pressure of environment to pressure sensor).
Regarding claim 55, Nitzan, Keren, and Tai disclose the limitations of claim 54, and further disclose the enclosed cavity includes a pressure transmission medium in communication with both the second biocompatible membrane and the pressure sensor (see Tai, par. 30-32, 43-44).
Regarding claim 56, Nitzan, Keren, and Tai disclose the limitations of claim 55, and further disclose the pressure transmission medium is a liquid (see Tai, par. 30-32, 43-44).
Regarding claim 57, Nitzan, Keren, and Tai disclose the limitations of claim 51, and Nitzan further discloses the first biocompatible membrane is composed at least in part of ePTFE (see par. 67, 122).
Regarding claim 58, Nitzan, Keren, and Tai disclose the limitations of claim 51, and Tai further discloses the second biocompatible membrane is composed at least in part of silicone (see par. 30).
Regarding claim 71, Nitzan discloses a medical device configured to be implanted at a septal wall of a patient (see Fig. 6B, Abstract), the medical device comprising: a frame comprising one or more structural elements configured to extend across the septal wall of the patient between a left atrium and a right atrium of the patient (see Figs. 5A-6A; par. 91-92); a first biocompatible membrane at least partially covering the frame and extending between a first portion of the frame configured to reside in the left atrium and a second portion of the frame configured to reside in the right atrium such that the first biocompatible membrane defines a lumen extending therebetween (see par. 91, arms can be covered with tissue or PTFE membranes and Fig. 6B; par. 11, 57, 90, 122-123).
Nitzan does not disclose a pressure sensor configured to measure a pressure in the left atrium or the right atrium.
Keren discloses an interatrial shunt placed between two chambers of the heart within the interatrial septum (see Fig. 1), between the right atrium and left atrium, the shunt comprising one or more pressure sensors used to measure the pressure in the subject’s right atrium and/or left atrium used to monitor progression of the treatment and ascertain the point in time at which the shunt may be removed from the patient, with one pressure sensor disposed on the proximal portion of the shunt and pressure another on the distal portion, such that the pressure in both the left atrium and the right atrium is measured (see par. 62). Consequently, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to add a sensor to the proximal portion of the shunt and to the distal portion of the shunt, which would cause one to be in the right atrium and one in the left atrium such that pressure in both the left atrium and the right atrium is measured, as disclosed by Keren, to monitor progression of the treatment and ascertain the point in time at which the shunt may be removed from the patient.
Nitzan and Keren do not disclose a second biocompatible membrane covering the pressure sensor and configured to fully reside in either the left atrium or the right atrium, wherein the pressure sensor is coupled to the frame, and wherein the second biocompatible membrane is discontinuous with the first biocompatible membrane.
Tai discloses biocompatible packaging for long term implantable sensors and electronics, wherein a pressure sensing system comprises a pressure sensor and a biocompatible membrane at least partially encasing the pressure sensor (see par. 30-32, 43, outer biocompatible membrane covering liquid covering pressure sensor, the membrane allowing for deflection to sense the environmental pressure) to protect against the conditions of the operational environment (see par. 30). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to replace each pressure sensor of Nitzan and Keren with one of Tai with a pressure sensing system that comprises a pressure sensor, biocompatible membrane, and liquid as disclosed by Tai that protects against the conditions of the operational environment. As each pressure sensor would be required to detect pressure in the left atrium or the right atrium due to the deflection of the membrane, one of ordinary skill would be motivated to place the pressure sensing system in an area that would detect pressure in the left atrium or the right atrium, and therefore to be placed on the shunt it would have to be securely placed on the shunt entirely in the right atrium or the left atrium. Consequently, it would reside on a single side of the septal wall in either the left atrium or the right atrium and would be coupled to the frame. Nitzan further discloses the first biocompatible membrane is composed at least in part of ePTFE (see par. 67, 122) and Tai further discloses the second biocompatible membrane is composed at least in part of silicone (see par. 30), therefore due to the different materials and parts, they would be discontinuous.
Regarding claim 72, Nitzan, Keren, and Tai disclose the limitations of claim 71 and Tai further discloses the second biocompatible membrane is a pressure responsive membrane configured to deflect in response to changes in blood pressure in the single side of the septal wall (see par. 30-32, 43).
Claim(s) 53 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nitzan, Keren, and Tai as applied to claim 51 above, and further in view of Najafi et al. (US 2012/0022507).
Regarding claim 53, Nitzan, Keren, and Tai disclose the limitations of claim 51, and while Nitzan discloses the lumen extends between a first orifice and a second orifice (see Figs. 6A-6B, openings at opposite ends of the frame), Nitzan does not disclose the second biocompatible membrane is positioned adjacent to the first orifice or the second orifice.
Najafi discloses an implant placed at a septal wall between the left and right atrium, the implant having two pressure sensors for measuring pressure in the right and left atriums, one sensor placed at
the end of the implant in the right atrium and one at the end of the implant in the left atrium (see par.
36). It would have been obvious to a person having ordinary skill in the art before the effective filing
date of the claimed invention to have the pressure sensor measuring the pressure in the left atrium to be located at the end portion of the left side of the implant and to have the sensor measuring the pressure in the right atrium to be located at the end portion of the right side of the implant, as disclosed by Najafi, this predictably resulting in measuring the left and right atrium pressures, which is showing as desirable by both Najafi and Nitzan (see rejection of claim 51 above). As each opposite end contains an orifice and each end would have a pressure sensor and associated liquid and membrane (see rejection of claim 51 above), the second biocompatible membrane would be positioned adjacent to either the first orifice or the second orifice.
Claim(s) 59, 61-64, and 73 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nitzan, Keren, and Tai as applied to claim 51 above, and further in view of Mendoza-Ponce et al. ("Super-capacitors for implantable medical devices with wireless power transmission," 2018 14th Conference on Ph.D Research in Microelectronics and Electronics (PRIME), Prague, Czech Republic, 2018, pages 241-244, 02-05 July 2018, 4 pages), submitted in the May 30, 2024 IDS.
Regarding claim 59, Nitzan, Keren, and Tai disclose the limitations of claim 51 but do not disclose an energy receiving component configured to (a) receive energy from an energy source positioned external to the patient's body, and/or (b) generate energy when exposed to a magnetic or electric field generated by an energy source positioned external to the patient's body, and wherein the energy received at and/or generated by the energy receiving component is configured to power the pressure sensor.
Mendoza-Ponce discloses an implantable energy receiving component (see page 242, par. 2,
power antenna coil receives wireless energy) configured to receive energy from an energy source positioned external to the patient’s body; and an implantable energy storage component (see page 242, para. 2-3, super-capacitor charged with DC power) configured to store energy received by the implantable energy receiving component, wherein the implantable energy storage component is further configured to selectively release the stored energy to power one or more active components of the system including pressure sensors (see Abstract, Fig. 1, page 241, par. 9-.page 242, par. 1-6, describing sampling of pressure sensor data via pressure sensor and powered by super- capacitor). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to add such components as those disclosed by Mendoza-Ponce to power the pressure sensors in order to help wirelessly power and transmit pressure information to monitor the patient, thereby the patient only needs to use the wireless telemetry unit a few minutes per day instead of wearing it on the body constantly (see page 241, par. 7).
Regarding claim 61, Nitzan, Keren, Tai, and Mendoza-Ponce disclose the limitations of claim 59 but do not disclose the energy receiving component is configured to abut the septal wall when the medical device is implanted at the septal wall such that the energy receiving component protrudes less than 2 mm away from the septal wall.
Rearrangement of parts has been found to be obvious. See In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) (Claims to a hydraulic power press which read on the prior art except with regard to the position of the starting switch were held unpatentable because shifting the position of the starting switch would not have modified the operation of the device.) In this case, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the energy receiving component configured to abut the septal wall when the medical device is implanted at the septal wall such that the energy receiving component protrudes less than 2 mm away from the septal wall as, similar to as in In re Japikse, shifting the position of the energy receiving component in such a manner would not have modified the operation of the device. Furthermore, it appears that applicant places no criticality on the position, indicating simply that some embodiments have such a position (see specification, par. 68).
Regarding claim 62, Nitzan, Keren, Tai, and Mendoza-Ponce disclose the limitations of claim 59 and Mendoza-Ponce further discloses the energy receiving component coupled to the pressure sensor (see Abstract, Fig. 1, page 241, par. 9-.page 242, par. 1-6, describing sampling of pressure sensor data via pressure sensor and powered by super- capacitor) and Keren discloses the pressure sensor coupled to the interatrial shunt (see par. 62), and therefore the energy receiving component would be coupled to the shunt.
Regarding claim 63, Nitzan, Keren, Tai, and Mendoza-Ponce disclose the limitations of claim 59 and Mendoza-Ponce further discloses an energy storage component configured to store energy received at and/or generated by the energy receiving component (see rejection of claim 59 and page 242, para. 2-3, super-capacitor charged with DC power).
Regarding claim 64, Nitzan, Keren, Tai, and Mendoza-Ponce disclose the limitations of claim 63 but as described above do not disclose the energy storage component positioned at least partially within the second biocompatible membrane.
Tai discloses that other packaged components such as actuators, electrical components, electronic components, and mechanical components can also have the membrane surround it (see Fig. 2, par. 45) as well as having a power management circuit, signal processing circuit element, power harvesting circuit element, or set of conductive wires along with a pressure sensor covered by a biocompatible membrane (see Fig. 9, par. 83). Consequently, as the energy storage component is associated with the power of the pressure sensor, it would have been obvious to a person having ordinary skill in the art before the effective filing date to additionally cover this component with the second biocompatible membrane, as disclosed by Tai, allowing for the protection against the conditions of the operational environment to extend to the energy storage component while also allowing for such parts that may not be biocompatible to still be placed within the patient (see Tai, par. 78).
Regarding claim 73, Nitzan, Keren, and Tai disclose the limitations of claim 71 but do not disclose the one or more structural elements include an energy receiving component configured to (a) receive energy from an energy source positioned external to the patient's body, and/or (b) generate energy when exposed to a magnetic or electric field generated by an energy source positioned external to the patient's body, and wherein the energy received at and/or generated by the energy receiving component is configured to power the pressure sensor.
Mendoza-Ponce discloses an implantable energy receiving component (see page 242, par. 2,
power antenna coil receives wireless energy) configured to receive energy from an energy source positioned external to the patient’s body; and an implantable energy storage component (see page 242, para. 2-3, super-capacitor charged with DC power) configured to store energy received by the implantable energy receiving component, wherein the implantable energy storage component is further configured to selectively release the stored energy to power one or more active components of the system including pressure sensors (see Abstract, Fig. 1, page 241, par. 9-.page 242, par. 1-6, describing sampling of pressure sensor data via pressure sensor and powered by super- capacitor). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to add such components as those disclosed by Mendoza-Ponce to power the pressure sensors in order to help wirelessly power and transmit pressure information to monitor the patient, thereby the patient only needs to use the wireless telemetry unit a few minutes per day instead of wearing it on the body constantly (see page 241, par. 7). As the energy receiving component would help create the structure of the frame, it is considered part of the one or more structural elements.
Claim(s) 65-67 and 69-70 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nitzan in view of Keren in view of Tai and further in view of Najafi.
Regarding claim 65, Nitzan discloses a medical device configured to be implanted at a septal wall of a patient (see Fig. 6B, Abstract), the medical device comprising: an interatrial shunt having a frame (see Figs. 5A-6A; par. 91-92) and a first biocompatible membrane coupled to the frame (see par. 91, arms can be covered with tissue or PTFE membranes and Fig. 6B; par. 122-123), wherein the first biocompatible membrane defines a lumen extending therethrough between a first aperture and a second aperture (see Fig. 6A-6B; par. 57, 123, apertures at opposite ends of the frame), and wherein the first biocompatible membrane is configured to span the septal wall of the patient when the frame is implanted at the septal wall such that the lumen fluidly connects the left atrium and the right atrium (see par. 11, 57, 90, 123).
Nitzan does not disclose a pressure sensing system having a pressure sensor.
Keren discloses an interatrial shunt placed between two chambers of the heart within the interatrial septum (see Fig. 1), between the right atrium and left atrium, the shunt comprising one or more pressure sensors used to measure the pressure in the subject’s right atrium and/or left atrium used to monitor progression of the treatment and ascertain the point in time at which the shunt may be removed from the patient, with one pressure sensor disposed on the proximal portion of the shunt and pressure another on the distal portion, such that the pressure in both the left atrium and the right atrium is measured (see par. 62). Consequently, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to add a sensor to the proximal portion of the shunt and to the distal portion of the shunt, which would cause one to be in the right atrium and one in the left atrium such that pressure in both the left atrium and the right atrium is measured, as disclosed by Keren, to monitor progression of the treatment and ascertain the point in time at which the shunt may be removed from the patient.
Nitzan and Keren do not disclose the pressure sensing system comprising a second biocompatible membrane at least partially encasing the pressure sensor, wherein the second biocompatible membrane resides on a single side of the septal wall in either the left atrium or the right atrium, and wherein the second biocompatible membrane is discontinuous with the first biocompatible membrane.
Tai discloses biocompatible packaging for long term implantable sensors and electronics, wherein a pressure sensing system comprises a pressure sensor and a biocompatible membrane at least partially encasing the pressure sensor (see par. 30-32, 43, outer biocompatible membrane covering liquid covering pressure sensor, the membrane allowing for deflection to sense the environmental pressure) to protect against the conditions of the operational environment (see par. 30). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to replace each pressure sensor of Nitzan and Keren with one of Tai with a pressure sensing system that comprises a pressure sensor, biocompatible membrane, and liquid as disclosed by Tai that protects against the conditions of the operational environment. As each pressure sensor would be required to detect pressure in the left atrium or the right atrium due to the deflection of the membrane, one of ordinary skill would be motivated to place the pressure sensing system in an area that would detect pressure in the left atrium or the right atrium, and therefore to be placed on the shunt it would have to be securely placed on the shunt entirely in the right atrium or the left atrium. Consequently, it would reside on a single side of the septal wall in either the left atrium or the right atrium. Nitzan further discloses the first biocompatible membrane is composed at least in part of ePTFE (see par. 67, 122) and Tai further discloses the second biocompatible membrane is composed at least in part of silicone (see par. 30), therefore due to the different materials and parts, they would be discontinuous.
Nitzan, Keren, and Tai do not disclose the second biocompatible membrane adjacent the first opening or the second opening.
Najafi discloses an implant placed at a septal wall between the left and right atrium, the implant having two pressure sensors for measuring pressure in the right and left atriums, one sensor placed at
the end of the implant in the right atrium and one at the end of the implant in the left atrium (see par.
36). It would have been obvious to a person having ordinary skill in the art before the effective filing
date of the claimed invention to have the pressure sensor measuring the pressure in the left atrium to be located at the end portion of the left side of the implant and to have the sensor measuring the pressure in the right atrium to be located at the end portion of the right side of the implant, as disclosed by Najafi, this predictably resulting in measuring the left and right atrium pressures, which is showing as desirable by both Najafi and Nitzan (see rejection of claim 51 above). As each opposite end contains an orifice and each end would have a pressure sensor and associated liquid and membrane (see rejection of claim 51 above), the second biocompatible membrane would be positioned adjacent to either the first orifice or the second orifice.
Regarding claim 66, Nitzan, Keren, Tai, and Najafi disclose the limitations of claim 65 and Tai further discloses the second biocompatible membrane is a pressure responsive membrane configured to deflect in response to changes in blood pressure in the single side of the septal wall (see par. 30-32, 43).
Regarding claim 67, Nitzan, Keren, Tai, and Najafi disclose the limitations of claim 66 and Tai further discloses the pressure sensing system further comprises an enclosed cavity containing a pressure transmission medium (see Tai, par. 30-32, 43, outer biocompatible membrane covering liquid covering pressure sensor, the membrane allowing for deflection to sense the environmental pressure, liquid fills cavity that would be between biocompatible membrane and pressure sensor that would transmit pressure of environment to pressure sensor), and wherein: the pressure responsive membrane at least partially covers the enclosed cavity (see par. 30-32), and the pressure sensor is in communication with the pressure transmission medium (see par. 30-32, 43).
Regarding claim 69, Nitzan, Keren, Tai, and Najafi disclose the limitations of claim 65, and Nitzan further discloses the first biocompatible membrane is composed at least in part of ePTFE (see par. 67, 122) and Tai further discloses the second biocompatible membrane is composed at least in part of silicone (see par. 30), therefore the first and second biocompatible membranes are composed of different materials.
Regarding claim 70, Nitzan, Keren, Tai, and Najafi disclose the limitations of claim 65 and as explained above, disclose the pressure sensing system is connected to the interatrial shunt (see rejection of claim 65 above, Keren discloses one pressure sensor disposed on the proximal portion of the shunt and pressure sensor on the distal portion, such that the pressure in both the left atrium and the right atrium is measured (see par. 62)).
Claim(s) 68 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nitzan in view of Keren in view of Tai and further in view of Najafi as applied to claim 65 above, and further in view of Yacoby et al. (US 2014/0350565).
Regarding claim 68, Nitzan, Keren, Tai, and Najafi disclose the limitations of claim 65 but do not disclose the first biocompatible membrane and the second biocompatible membrane are composed of the same material.
Yacoby discloses that a suitable cover for the frame of a shunt, the cover being a first biocompatible membrane, would be a sheet of polymer such as ePTFE or silicone (see par. 66). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the cover be silicone, Yacoby disclosing such a material as a well-known alternative/substitution of ePTFE for the cover/first biocompatible membrane of a frame configured to extend across the septal wall of a patient between a left atrium and right atrium (see Fig. 2B), and predictably resulting in a polymeric biocompatible membrane covering of a frame. See MPEP 2144.06(II). Furthermore, even if they are the same materials, they would be different parts and therefore discontinuous.
Allowable Subject Matter
Claim 60 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Regarding claim 60, Nitzan, Keren, Tai, and Mendoza-Ponce disclose the limitations of claim 59 and while Mendoza-Ponce discloses the energy receiving component includes a coil having a plurality of loops (see Fig. 2, page 242, par. 2, 7) but does not disclose the loops arranged coaxial with the lumen. Furthermore, placing the coil in such a way that the loops are arranged coaxial with the lumen would cause the coil to interfere with the flow through the lumen, and thus one of ordinary skill in the art would not be motivated to position the energy receiving component in such a position.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Govari et al. (US 6,053,873), disclosing a pressure-sensing stent with associated pressure sensor and membrane; Schugt et al. (US 2006/0247539) disclosing an implantable capacitive pressure sensor system with associated pressure sensor and membrane; Stern et al. (US 2008/0082005) disclosing a method for using a wireless pressure sensor to monitor pressure inside the human heart with the pressure associated with a pressure sensor and membrane.
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/ARIANA ZIMBOUSKI/ Primary Examiner, Art Unit 3781
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