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 .
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:
Claim 1,
“electronics unit”
Claim 18
“wireless communication unit”
Claim 20
“signal conditioning unit”
Claim 21
“data processing unit”; “signal conditioning unit”
Claim 24, 29,
“electronics unit”
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.
Claim 10 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.
The term “some of the acoustic transducer elements” in claim 10 is a relative term which renders the claim indefinite. The term “some of the acoustic transducer elements” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
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.
Claim(s) 1, 7, 10-12, 18, 20-21, 34, 43 are rejected under 35 U.S.C. 103 as being unpatentable over Shurtliff et al (Pub. No.: US 2021/0169443) in view of Munoz et al (Pub. No.: US 2018/0303419).
Regarding claim 1, Shurtliff et al disclose a sensor device for in vivo monitoring of blood flow in a blood vessel [see 0006, 0024-0025], comprising:
a first arm (band 102; see 0027) configured to attach to a first exterior portion of the blood vessel (brachial artery 11) and a second arm (band 104, see 0027) configured to attach to a second exterior portion of the blood vessel (brachial artery 11) [see 0006, 0024-0025, 0032-0033, abstract, fig 1B];
a connection apparatus (106) coupled to each of the first arm (band 102 behaves as two separate arms that holds housing 108 and 110 that contains the transducers, emphasis added) and the second arm (band 104) [see 0027-0029, figs 1A-1B];
an ultrasound sensor assembly comprising a first ultrasound sensor assembly (first housing 108) and a second ultrasound sensor assembly (second housing 110) [see 0029];
the first ultrasound sensor assembly (108) comprising a first set of one or more acoustic transducer elements coupled to the first arm [see 0005, 0007, 0011, 0025, 0042, 0060, claims 21-22];
the second ultrasound sensor assembly (110) comprising a second set of one or more acoustic transducer elements coupled to the second arm [see 0005, 0007, 0011, 0025, 0042, 0060, claims 21-22];
wherein one or both of the first set of one or more acoustic transducer elements and the second set of one or more acoustic transducer elements include at least one of:
a first acoustic transducer element that is configured to transmit an acoustic signal to propagate through the blood vessel [see 0005, 0007, 0011, 0025, 0042, 0060, claims 21-22] by disclosing the microprocessor or other suitable control element operates to select a particular subset of transmitter elements within the transducer array through which ultrasound energy is transmitted and/or select a particular subset of receiver elements within the transducer array through which a reflected ultrasound signal is obtained [see 0011];
or
a second acoustic transducer element and configured to receive acoustic signals that have propagated through the blood vessel and are indicative of a fluid flow parameter of blood in the blood vessel [see 0005, 0007, 0011, 0025, 0042, 0060, claims 21-22] by disclosing the microprocessor or other suitable control element operates to select a particular subset of transmitter elements within the transducer array through which ultrasound energy is transmitted and/or select a particular subset of receiver elements within the transducer array through which a reflected ultrasound signal is obtained [see 0011];
an electronics unit housed in the connection apparatus and in electrical communication with the first ultrasound sensor assembly and the second ultrasound sensor assembly [see 0005, 0052] by disclosing the wearable monitoring device also includes an electronics assembly operatively coupled to the first and second transducer arrays. The electronics assembly includes one or more control components, such as a microprocessor [see 0005];
the electronics unit configured to process electrical signals associated with the received acoustic signals as data [see 0005, claims 21-22] and wherein the electronics assembly includes a communications module configured to communicatively couple the monitoring device to one or more external computer systems [see claim 18] and electronics assembly 300 also includes a communications module 356 communicatively coupled to the microprocessor 350 shown in this embodiment as a Bluetooth Low Energy (BLE) module [see 0052].
Shurtliff et al disclose wherein the first and second transducer arrays each include a layer of piezoelectric material [see 0047, claim 15]; however, Shurtliff et al don’t disclose wherein at least one of the first set or the second set of the one or more acoustic transducer elements includes a piezoelectric micromachined ultrasonic transducer (PMUT).
Nonetheless, Munoz et al disclose adding a thin layer of piezo-electric material on diaphragm (PMUT) [see 0046] and further disclose wireless technology standard for exchanging data over short distances [see 0058].
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Shurtliff et al, Munoz et al by using a piezoelectric micromachined ultrasonic transducer (PMUT); PMUTs are compact and energy-efficient, making them suitable for portable devices and medical diagnostics; they are designed to withstand high mechanical loads, enhancing their reliability in various applications fabricated using established MEMS processes, PMUTs enable cost-effective scalability and seamless integration into systems.
Regarding claim 7, Shurtliff et al disclose wherein the ultrasound sensor assembly further comprises a substrate (coupler 116) connected to an interior-facing surface of at least one of the first arm (band 102) [see 0027]
or
the second arm (band 104) and that couples at least one of the first set or the second set of one or more acoustic transducer elements [see 0027]
Regarding claim 10, Shurtliff et al disclose comprises an acoustic transducer pad that couples to at least some of the acoustic transducer elements of the ultrasound sensor assembly and is configured to provide a contour and cushion against the exterior portion of the blood vessel [see 0049] by disclosing acoustically-transparent material 232 may include a gel pad that acoustically couples the array 218 to the user's skin when the user wears the device. The gel pad may include, for example, propylene glycol, glycerine, carbomer, agarose, gelatin, other suitable gelling agents, or combinations thereof [see 0049].
Regarding claim 11, Shurtliff et al disclose wherein the acoustic transducer pad includes a hydrogel [see 0049] by disclosing acoustically-transparent material 232 may include a gel pad that acoustically couples the array 218 to the user's skin when the user wears the device. The gel pad may include, for example, propylene glycol, glycerine, carbomer, agarose, gelatin, other suitable gelling agents, or combinations thereof [see 0049].
Regarding claim 12, Shurtliff et al disclose wherein the first arm and the second arm are is operable to secure the sensor device to the exterior portion of the blood vessel with pliability for the sensor device to be stable in its placement with respect to the blood vessel while withstanding continuous movements of the blood vessel to which its attached [see figs 1A-1B].
Regarding claim 18, Shurtliff et al disclose wherein the electronics unit comprises a power supply [see 0054];
Shurtliff et al disclose electronics assembly 300 also includes a communications module 356 communicatively coupled to the microprocessor 350. The communications module 356 is shown in this embodiment as a Bluetooth Low Energy (BLE) module [see 0052, claim 19]; therefore, a wireless transmitter or wireless transceiver is inherently disclosed because a receiver is needed to receive wireless signals (emphasis added).
Regarding claim 20, Shurtliff et al disclose wherein the electronics unit comprises a signal conditioning unit (analog-to-digital converters (ADCs) 482) in communication with the acoustic transducer elements of the ultrasound sensor assembly via one or more electrical interface components [see 0062];
the signal conditioning unit comprising an electrical circuit configured to process the electrical signals associated with the received acoustic signals by one or more of:
amplifying the electrical signals [see 0061]
filtering the electrical signals [see 0064]
or
converting (via analog-to-digital converters (ADCs) 482) the electrical signals from analog to digital [see 0060, 0062].
Regarding claim 21, Shurtliff et al disclose a data processing unit in communication with the signal conditioning unit, the data processing unit comprising a processor and a memory and configured to process the amplified,
filtered [see 0064];
or
converted electrical signals as the data representative of the flow of blood in the blood vessel [see 0061-0062].
Regarding claim 29, Shurtliff et al disclose a secondary sensor coupled to at least one of the first arm (band 102), the second arm (band 104) [see 0032, 0054-0056] by disclosing one or more compartments 115 may also be built into the device 100 to house circuit boards, batteries, additional sensors [see 0032];
or
the connection apparatus and in communication with the electronics unit, the secondary sensor operable to measure one or more of a biological parameter, a physiological parameter, an electrophysiological parameter, or a physical parameter of a body of a patient within which the sensor device is deployed.
Regarding claim 34, Shurtliff et al disclose a secondary attachment component disposed on one or both of the first arm and the second arm and configured to secure the sensor device to the blood vessel [see 0027, 0032, 0054] by disclosing Each band 102, 104 also includes a coupler 116 allowing the bands to be custom sized to fit an individual user. The couplers 116 may be formed as buckles, clasps, loops, or other suitable fastening means known in the art. The end portions of each band 102, 104 may include corresponding sections of hook and loop fastener material [see 0027]
Regarding claim 43, Shurtliff et al disclose wherein the fluid flow parameter of the blood in the blood vessel includes at least one of:
a flow rate [see 0024-0025] by disclosing monitor the time delay between a blood flow pulse at the proximal array and the same flow pulse at the distal array [see 0025]. As disclosed herein, Flow rate is defined as the volume of fluid that passes through a specific point in a system per unit of time (emphasis added)
or
an amount of pressure difference between ends of a flow path in the blood vessel
Claim(s) 6 is rejected under 35 U.S.C. 103 as being unpatentable over Shurtliff et al (Pub. No.: US 2021/0169443) in view of Munoz et al (Pub. No.: US 2018/0303419) as applied to claim 1 above and further in view of Vortman et al (Pub. No.: US 2004/0236253).
Regarding claim 6, Shurtliff et al and Munoz et al don’t disclose the first acoustic transducer element
the second acoustic transducer element,
or
a third acoustic transducer element is configured to have a size dimension between 1 mm to 4 mm.
Nonetheless, Vortman et al disclose a size dimension between 1 mm to 4 mm [see 0028].
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Shurtliff et al, Munoz et al and Vortman et al by using a size dimension between 1 mm to 4 mm; to provide a compact device.
Claim(s) 8 is rejected under 35 U.S.C. 103 as being unpatentable over Shurtliff et al (Pub. No.: US 2021/0169443) in view of Munoz et al (Pub. No.: US 2018/0303419) as applied to claim 1 above and further in view of Tavakoli et al (Pub. No.: US 2022/0031181)
Regarding claim 8, Shurtliff et al and Munoz et al don’t disclose wherein the substrate is configured to provide a heat sync for management of thermal generation by the at least one of:
the first set
or
the second set of one or more acoustic transducer elements.
Nonetheless, Tavakoli et al disclose the circuit board may be designed with the intent of dissipating heat, e.g., by including thick conductive layers, exposed copper, heatsink, or similar [see 0049].
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Shurtliff et al, Munoz et al and Tavakoli et al by providing a heat sync for management of thermal generation; to prevent burns on the skin [see 0049].
Claim(s) 24, 50 are rejected under 35 U.S.C. 103 as being unpatentable over Shurtliff et al (Pub. No.: US 2021/0169443) in view of Munoz et al (Pub. No.: US 2018/0303419) as applied to claim 1 above and further in view of Lec et al (Pub. No.: US 2007/0163353)
Regarding claim 24, Shurtliff et al and Munoz et al don’t disclose wherein the electronics unit comprises a casing that encompasses the electronics unit to protect the electronics unit from exposure to a body fluid when the sensor device is inserted and deployed in vivo.
Nonetheless, Lec et al disclose a casing that encompasses the electronics unit to protect the electronics unit from exposure to a body fluid when the sensor device is inserted and deployed in vivo [see 0042, fig 8] by disclosing a packaging section may be included to house the sensor and electronic units [see 0042].
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Shurtliff et al, Munoz et al and Lec et al by using a casing that encompasses the electronics unit to protect the electronics unit from exposure to a body fluid when the sensor device is inserted and deployed in vivo; to minimize corrosion to the electronic unit.
Regarding claim 50, Shurtliff et al and Munoz et al don’t disclose wherein the first arm and the second arm are positioned on a pulmonary artery or pulmonary vein;
wherein the received acoustic signals are indicative of blood flow within the pulmonary artery or the pulmonary vein.
Nonetheless, Lec et al disclose wherein the first arm and the second arm are positioned on a pulmonary artery or pulmonary vein [see 0050, 0065]
wherein the received acoustic signals are indicative of blood flow [see 0057-0058] within the pulmonary artery or the pulmonary vein [see 0057-0058, 0065] by further disclose the conduit could be pulmonary artery [see 0065].
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Shurtliff et al, Munoz et al and Lec et al by positioning first arm (elastic support) and the second arm are positioned on a pulmonary artery or pulmonary vein; Monitoring Heart Function: Pulmonary vein measurements can provide insights into left ventricular diastolic function, helping to identify potential heart issues; making accurate measurement essential for diagnosis and management.
Claim(s) 5, 14-15, 35 are rejected under 35 U.S.C. 103 as being unpatentable over Shurtliff et al (Pub. No.: US 2021/0169443) in view of Munoz et al (Pub. No.: US 2018/0303419) as applied to claim 1 above and further in view of Waldhauser et al (Pub. No.: US 2021/0001116).
Regarding claim 5, Shurtliff et al and Munoz et al don’t disclose a reflector disposed on one or both of the first arm and the second arm.
Nonetheless, Waldhauser et al disclose a reflector (radiopaque marker) disposed on one or both of the first arm and the second arm [see 0345, 0693]
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Shurtliff et al, Munoz et al and Waldhauser et al by using a reflector disposed on one or both of the first arm and the second arm; for tracking purposes.
Regarding claims 14, 35, Shurtliff et al and Munoz et al don’t disclose wherein at least one of the first arm (splines 2204) or the second arm (splines 2204/2404) comprises a shape-stiffener component (shape memory) that is pre-shaped and is capable of undergoing a shape change.
Nonetheless, Waldhauser et al disclose wherein at least one of the first arm (splines 2204) or the second arm (splines 2204/2404) comprises a shape-stiffener component that is pre-shaped and is capable of undergoing a shape change [see 24A-B, 0960].
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Shurtliff et al, Munoz et al and Waldhauser et al by having at least one of the first arm or the second arm comprises a shape-stiffener component that is pre-shaped and is capable of undergoing a shape change; so that the arms could conform with different positioning due to physiological arterial blood pressure pulsation [see 0136-0137].
Regarding claim 15, Shurtliff et al, Munoz et al and Lec et al don’t disclose wherein the shape-stiffener component comprises one or more of Nitinol, gold, platinum, or iridium
Nonetheless, Waldhauser et al disclose wherein the shape-stiffener component (support wires) comprises one or more of Nitinol, gold, platinum, or iridium [see 0796, 0941],
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Shurtliff et al, Munoz et al and Waldhauser et al by using one or more of Nitinol, gold, platinum, or iridium; because Nitinol can undergo significant deformation without permanent damage, making it ideal for flexible medical devices.
Regarding claim 49, Shurtliff et al, Munoz et al don’t disclose wherein the first arm and the second arm are positioned on a superior vena cava or an inferior vena cava;
wherein the received acoustic signals are indicative of blood flow within the superior vena cava or the inferior vena cava.
Nonetheless, Waldhauser et al disclose wherein the first arm (splines 2204) and the second arm (spline 2204 that comprises a sensor) are positioned on a superior vena cava or an inferior vena cava [see 0029, 0864, 0885, figs 22E];
wherein the received acoustic signals are indicative of blood flow within the superior vena cava or the inferior vena cava [see 0867] by disclosing the first sensor 1866 can be a piezoelectric transducer (e.g., a microphone) or a blood flow sensor and configured to measure a velocity of blood to estimate blood flow volume [see 0867]
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Shurtliff et al, Munoz et al and Waldhauser et al by having the first arm and the second arm are positioned on a superior vena cava or an inferior vena cava and wherein the received acoustic signals are indicative of blood flow within the superior vena cava or the inferior vena cava; to measure a velocity of blood to estimate blood flow volume [see 0867].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOEL F BRUTUS whose telephone number is (571)270-3847. The examiner can normally be reached Mon-Sat, 11:00 AM to 7:00 PM.
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/JOEL F BRUTUS/ Primary Examiner, Art Unit 3797