DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1/8/2026 has been entered.
Acknowledgements
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-4, 6-33 are pending.
This action is Non- Final.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Claim Objections
Claims 1, 6, 29-31 are objected to for applicant making untracked changes which are not in compliance with Rule 1.121 and/or uses incorrect claim status as claims 6, 28 are not in original form but previously presented form. No correction is being required by applicant as the presented form of claims are treated as replacing the prior form of claims. However, Applicant is warned that any further amendments not in compliance with Rule 1.121 will be treated as non-compliant and any further incorrect claim status will be treated as non-responsive.
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 29, 31-33 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 29 recites the limitation "the impedance signal". There is insufficient antecedent basis for this limitation in the claim.
Claim 31 recites the limitation "the impedance signal". There is insufficient antecedent basis for this limitation in the claim.
The dependent claims are rejected for depending on a rejected claim.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-4, 6-8, 11, 19, 25-29, 31-33 are rejected under 35 U.S.C. 103 as being unpatentable over Edman et al. (Edman, US 2011/0208067) in view of Halac et al. (Halac, US 2019/0336048) and Patil et al. (Patil, US 2012/0071782).
Regarding claim 1, Edman teaches a system for characterizing blood flow in a blood vessel comprising:
an impedance system comprising at least one current-injecting electrode configured to inject an electrical current into the vessel, and at least one signal-measuring electrode configured to measure an impedance signal affected by the injected electrical current and blood flow in the vessel, wherein the current-injecting and signal-measuring electrodes are adapted to be connected directly to the vessel (see at least Figure 1, [0019], [0037], [0135]-[0138] delivery and sensing); and
a processing system configured to receive the impedance signal from the impedance system, or a signal determined therefrom, and then process it to determine a parameter related to the blood flow in the vessel (see at least Figure 1 140, [0039], [0136]-[0140]);
while Edman teaches that circuit module can be implanted or can be external to the body to process physiological signals by way of percutaneous wire connections which teaches structures adapted to connect to the at least one of the current-injecting and signal-measuring electrodes (see at least [0039]), but there is no mention of the structure of external placement to teach the limitations of wherein the impedance system further comprises a body-worn patch, and the feature of wherein a frequency of the electrical current ranges from 5-500kHz is not taught.
Halac teaches a related system for measuring different physiological signals, including impedance (see [0070]), and teaches that a medical device can be a multisensory patch to determine desired physiological data, which reasonably teaches a body-worn patch (see [0070]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine prior art elements according to known methods to yield predictable results of including a patch containing the external components of a medical system in order to secure an external portion to a patient during use by way of a known patch design.
Patil teaches a related system for measuring vessel lumen information including inside or outside the lumen (see title abstract, [0167]), and teaches that impedance can be measured at a wide range of frequency as desired (see at least Figures 2-4), where such injected current can include any desired frequency across 100Hz to 100Mhz which meets the claimed range from 5-5000kHz (see at least Figures 2-4, [0164], [0171]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use whatever injecting current frequency was desired in known ranges in order to measure impedance. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) In re Bergen, 120 F.2d 329, 332, 49 USPQ 749, 751-52 (CCPA 1941).
Regarding claim 2, the limitations are met by Edman in view of Halac and Patil, where Edman teaches wherein at least one of the current-injecting and signal-measuring electrodes comprises a conductive material (see at least [0066] conductive polymer).
Regarding claim 3, the limitations are met by Edman in view of Halac and Patil, where Edman teaches wherein at least one of the current-injecting and signal-measuring electrodes comprises a resorbable material (see at least [0066] conductive polymer).
Regarding claim 4, the limitations are met by Edman in view of Halac and Patil, where Edman teaches wherein at least one of the current-injecting and signal-measuring electrodes comprises a material selected from the group consisting of a conductive polymer, zinc, iron, magnesium, and manganese (see at least [0066] conductive polymer).
Regarding claim 6, the limitations are met by Edman in view of Halac and Patel, where the combination teaches wherein the body-worn patch comprises a circuit board comprising an impedance circuit (see Halac [0070] patch; see Edman [0039]-[0042]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine prior art elements according to known methods to yield predictable results of including a patch containing the external components of a medical system in order to secure an external portion to a patient during use by way of a known patch design.
Regarding claim 7, the limitations are met by Edman in view of Halac and Patil, where Edman teaches wherein the circuit board connects through a cable to the at least one of the current-injecting and signal-measuring electrodes (see at least [0039]).
Regarding claim 8, the limitations are met by Edman in view of Halac and Patil, where Edman teaches wherein the cable comprises a conductive material (see at least [0039], [0079]).
Regarding claim 11, the limitations are met by Edman in view of Halac and Patil, where Edman teaches wherein the impedance signal is a time-domain waveform (see at least [0137]).
Regarding claim 19, the limitations are met by Edman in view of Halac and Patil, where Edman teaches further comprising an optical system configured to measure optical signals from the vessel (see at least [0050], [0140] photonic signals/sensing).
Regarding claim 25, the limitations are met by Edman in view of Halac and Patil, where Edman teaches further comprising a wireless transmitter (see at least Figure 17, [0156]).
Regarding claim 26, the limitations are met by Edman in view of Halac and Patil, where Edman teaches wherein the wireless transmitter is further configured to transmit the parameter related to the blood flow in the vessel, or a parameter derived therefrom, to a remote system (see at least Figure 17, [0156]).
Regarding claim 27, the limitations are met by Edman in view of Halac and Patil, where Edman teaches wherein the remote system is selected from the group consisting of a computer, mobile telephone, tablet computer, server, and cloud-based system (features further limited outside the claimed system and are inference: see at least Figure 17, [0156]).
Regarding claim 28, the limitations are met by Edman in view of Halac and Patil, where Edman teaches wherein the wireless transmitter is selected from the group consisting of transmitters operating on BLUETOOTH®, Wi-Fi™ and other wireless networks, and cellular protocols (structure is capable of operating on each, but especially meets other wireless networks: see at least Figure 17, [0156]).
Regarding claim 29, Edman teaches a system for characterizing blood flow in a blood vessel, comprising:
an electrical system comprising at least one current-injecting electrode configured to inject an electrical current into the vessel, and at least one signal-measuring electrode configured to measure an electrical signal affected by the injected electrical current and blood flow in the vessel, wherein the current-injecting and signal-measuring electrodes are adapted to be connected directly to the vessel (see at least Figure 1, [0019], [0037], [0135]-[0138] delivery and sensing); and
a processing system configured to receive the electrical signal from the electrical system, or a signal determined therefrom, and then process it to determine a parameter related to the blood flow in the vessel (see at least Figure 1 140, [0039], [0136]-[0140]);
wherein the impedance signal is a time-domain waveform (see at least [0137]);
while Edman teaches that circuit module can be implanted or can be external to the body to process physiological signals by way of percutaneous wire connections which teaches structures adapted to connect to the at least one of the current-injecting and signal-measuring electrodes (see at least [0039]), but there is no mention of the structure of external placement to teach the limitations of wherein an impedance system further comprises a body-worn patch, and the feature of wherein a frequency of the electrical current ranges from 5-500kHz is not taught.
Halac teaches a related system for measuring different physiological signals, including impedance (see [0070]), and teaches that a medical device can be a multisensory patch to determine desired physiological data, which reasonably teaches a body-worn patch (see [0070]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine prior art elements according to known methods to yield predictable results of including a patch containing the external components of a medical system in order to secure an external portion to a patient during use by way of a known patch design.
Patil teaches a related system for measuring vessel lumen information including inside or outside the lumen (see title abstract, [0167]), and teaches that impedance can be measured at a wide range of frequency as desired (see at least Figures 2-4), where such injected current can include any desired frequency across 100Hz to 100Mhz which meets the claimed range from 5-5000kHz (see at least Figures 2-4, [0164], [0171]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use whatever injecting current frequency was desired in known ranges in order to measure impedance. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) In re Bergen, 120 F.2d 329, 332, 49 USPQ 749, 751-52 (CCPA 1941).
Regarding claim 31, Edman teaches an impedance system for characterizing blood flow in a blood vessel, comprising:
an impedance circuit (see at least Figure 1 140);
an electrode system adapted to be attached directly to the vessel and electrically connected to the impedance circuit, at least one of the current-injecting and signal-measuring electrodes (see at least Figure 1, [0019], [0037], [0135]-[0138] delivery and sensing); and
a processing system configured to receive signals from the impedance circuit and process them to estimate blood flow in the vessel (see at least [0151] processor, [0039], [0136]-[0140]),
wherein the impedance signal is a time-domain waveform (see at least [0137]).
Edman teaches that circuit module can be implanted or can be external to the body to process physiological signals by way of percutaneous wire connections, which teaches “connect to” (see at least [0039]), but there is no mention of the structure of external placement to teach the limitations of the impedance system further comprises a body worn patch, and the feature of wherein a frequency of the electrical current ranges from 5-500kHz is not taught.
Halac teaches a related system for measuring different physiological signals, including impedance (see [0070]), and teaches that a medical device can be a multisensory patch to determine desired physiological data, which reasonably teaches a body-worn patch (see [0070]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine prior art elements according to known methods to yield predictable results of including a patch containing the external components of a medical system in order to secure an external portion to a patient during use by way of a known patch design.
Patil teaches a related system for measuring vessel lumen information including inside or outside the lumen (see title abstract, [0167]), and teaches that impedance can be measured at a wide range of frequency as desired (see at least Figures 2-4), where such injected current can include any desired frequency across 100Hz to 100Mhz which meets the claimed range from 5-5000kHz (see at least Figures 2-4, [0164], [0171]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use whatever injecting current frequency was desired in known ranges in order to measure impedance. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) In re Bergen, 120 F.2d 329, 332, 49 USPQ 749, 751-52 (CCPA 1941).
Regarding claim 32, the limitations are met by Edman in view of Halac and Patil, where Edman teaches wherein said blood vessel comprises a vein or artery (limits intended use, see at least Figure 1).
Regarding claim 33, the limitations are met by Edman in view of Halac and Patil, where Edman teaches a method for characterizing blood flow in a blood vessel, comprising applying the system of claim 32 to an area where blood flow is to be measured (see at least Figure 1).
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Edman et al. (Edman, US 2011/0208067) in view of Halac et al. (Halac, US 2019/0336048) and Patil et al. (Patil, US 2012/0071782) as applied to claim 8 above, and further in view of Rodgers et al. (Rodgers, US 2017/0020402).
Regarding claim 9, the limitations are met by Edman in view of Halac and Patil, where Halac teaches that technology can be improved, including conductive polymers (see [0127], but the limitations that the cable comprises a resorbable material is not directly taught.
Rodgers teaches a related system for using bioresorbable materials (see title and abstract), and teaches the usage of resorbable metal wires including Mo or Mg, which reasonably teaches the cable comprises a resorbable material (see at least [0082]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine prior art elements according to known methods to yield predictable results of using bioresorbable materials for conductive metallic wires in order to allow for electrical signal conduction for a shortened desired time period and allowing the body to absorb the materials when sensing life is over.
Regarding claim 10, the limitations are met by Edman in view of Halac and Patil and Rodgers, where Rodgers teaches the cable comprises a material selected from the group consisting of a conductive polymer, zinc, iron, magnesium, and manganese (see at least [0082]).
Claims 12-13, 18 are rejected under 35 U.S.C. 103 as being unpatentable over Edman et al. (Edman, US 2011/0208067) in view of Halac et al. (Halac, US 2019/0336048) and Patil et al. (Patil, US 2012/0071782) as applied to claim 11 above, and further in view of Bonnet et al. (Bonnet, US 2016/0082264).
Regarding claim 12, the limitations are met by Edman in view of Halac and Patil, where Edman teaches obtaining information from pulse beats (see at least [0137]-[0138]), the limitations of wherein the processing system is further configured to process the time-domain waveform to measure one or more heartbeat-induced pulses are not directly taught.
Bonnet teaches a related system which measures bioimpedance (see at least title, abstract, Figures 4-5, 7-9, [0045]-[0048], [0052], [0062]-[0063], [0079]), including wherein the processing system is further configured to process the time-domain waveform to measure one or more heartbeat-induced pulses (see at least [0062]-[0063], [0079], Figures 7-9, claim 1). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine prior art elements according to known methods to yield predictable results of using impedance time data to measure pulses in order to determine different blood flow related parameters such as heart rate.
Regarding claim 13, the limitations are met by Edman in view of Halac and Patil and Bonet, where Bonnet teaches wherein the processing system is further configured to process the heartbeat-induced pulses to determine the parameter related to blood flow in the vessel (see at least [0062]-[0063], [0079], Figures 7-9, claim 1).
Regarding claim 18, the limitations are met by Edman in view of Halac and Patil as proposed above, except the combination is silent to the features wherein the impedance system is configured to inject electrical current into the vessel at multiple, unique frequencies.
Bonnet teaches a related system which measures bioimpedance (see at least title, abstract, Figures 4-5, 7-9, [0045]-[0048], [0052], [0062]-[0063], [0079]), including wherein the impedance system is configured to inject electrical current into the vessel at multiple, unique frequencies (see at least [0052]), In addition, Patil teaches different frequencies in a range may be used for measurements (see at least [0020]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine prior art elements according to known methods to yield predictable results of allowing a current injection frequency to be changed to multiple frequencies in order to allow impedance measurements at variable defined frequencies as desired by a programmer or user.
Claim 14-17 are rejected under 35 U.S.C. 103 as being unpatentable over Edman et al. (Edman, US 2011/0208067) in view of Halac et al. (Halac, US 2019/0336048) and Patil et al. (Patil, US 2012/0071782) as applied to claim 1 above, and further in view of Sweeney et al. (Sweeney, US 2020/0129087).
Regarding claim 14, the limitations are met by Edman in view of Halac and Patil, except the limitations of wherein the impedance system is further configured to measure a capacitance value of the vessel is not directly taught.
Sweeney teaches a related system for measuring bioimpedance and parameters from bioimpedance (see at least abstract, Figures 1-4, [0173], [0223]-[0226]), including wherein the impedance system is further configured to measure a capacitance value of the vessel (see at least [0147]-[0148], [0261]-[0264]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine prior art elements according to known methods to yield predicable results of including a capacitance measurements with impedance system as taught by Sweeney in order to measure multiple features from capacitance such as dimensional features of blood vessels (see Sweeney [0124]).
Regarding claim 15, the limitations are met by Edman in view of Halac and Patil and Sweeney, where Sweeney teaches wherein the processing system is further configured to process the capacitance value to determine the parameter related to blood flow in the vessel (see at least [0147]-[0148], [0261]-[0264]).
Regarding claim 16, the limitations are met by Edman in view of Halac and Patil and Sweeney, where Sweeney teaches wherein the capacitance value is a resonant frequency corresponding to the vessel (result of such measurement of capacitance, see at least [0147]-[0148], [0261]-[0264]).
Regarding claim 17, the limitations are met by Edman in view of Halac and Patil, except the combination is silent to the features wherein the impedance system is configured to inject electrical current into the vessel at a single frequency.
Sweeney teaches a related system for measuring bioimpedance and parameters from bioimpedance (see at least abstract, Figures 1-4, [0173], [0223]-[0226]), including wherein the impedance system is configured to inject electrical current into the vessel at a single frequency (see at least [0212]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine prior art elements according to known methods to yield predicable results of including injection of current at a desired single frequency in order to measure constant impedance changes related to the desired frequency in monitored tissue/vessels.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Edman et al. (Edman, US 2011/0208067) in view of Halac et al. (Halac, US 2019/0336048) and Patil et al. (Patil, US 2012/0071782) as applied to claim 19 above, and further in view of Joseph (US 2016/0287174).
Regarding claim 20, the limitations are met by Edman in view of Halac and Patil, except the limitations of wherein the optical system comprises at least one light source and at least one photodetector are not directly taught.
Joseph teaches a related system for monitoring vessel features with physiological sensors in direct contact with vessels, and teaches at least one light source and at least one photodetector (see at least Figures 1-5, [0028]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine prior art elements according to known methods to yield predictable results of including light sensing elements in order to sense photonic information as suggested in combination with impedance by Edman, and in order to measure blood flow photonically.
Claims 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Edman et al. (Edman, US 2011/0208067) in view of Halac et al. (Halac, US 2019/0336048) and Patil et al. (Patil, US 2012/0071782) and Joseph (US 2016/0287174) as applied to claim 20 above, and further in view of Diab et al. (Diab, US 2009/0209835).
Regarding claim 21, the limitations are met by Edman in view of Halac and Patil and Joseph, except the limitations wherein the at least one light source is configured to emit optical radiation in the infrared spectral region are not directly taught.
However, this aspect is well known in oximetry in order to generate PPG signals for measuring oxygen saturation or blood flow, and is taught by Diab (see entire document, especially Figure 3, [0056]-59). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine prior art elements according to known methods to yield predictable results of measuring infrared signals of blood in order to generate data such as flow or saturation.
Regarding claim 22, the limitations are met by Edman in view of Halac, Patil, Joseph and Diab, where Diab teaches wherein the optical system is further configured to measure an optical spectrum in an infrared spectral region (see at least [0051], [0082]).
Claims 23-24 are rejected under 35 U.S.C. 103 as being unpatentable over Edman et al. (Edman, US 2011/0208067) in view of Halac et al. (Halac, US 2019/0336048) and Patil et al. (Patil, US 2012/0071782) as applied to claim 1 above, and further in view of Stahmann et al. (Stahmann, US 2013/0041269).
Regarding claim 23, the limitations are met by Edman in view of Halac and Patil, except the features of teaches further comprising an accelerometer are not directly taught.
Stahmann teaches a related system for measuring bioimpedance (see at least Figures 1-3B, [0039], [0050]-[0059]), including a system which further includes an accelerometer (see at least [0089]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine prior art elements according to known methods to yield predictable results of including an accelerometer in an impedance sensing system in order to allow for patient movements to be sensed (see Stahmann [0089]).
Regarding claim 24, the limitations are met by Edman in view of Halac and Stahmann, where Stahmann teaches wherein the processing system is further configured to measure motion-related signals from the accelerometer to determine motion corresponding to the patient (see at least [0089]).
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Edman et al. (Edman, US 2011/0208067) in view of Joseph (US 2016/0287174) and Halac et al. (Halac, US 2019/0336048) and Patil et al. (Patil, US 2012/0071782).
Regarding claim 30, Edman teaches a system for characterizing blood flow in a blood vessel, comprising:
an impedance system comprising at least one current-injecting electrode configured to inject an electrical current into the vessel, and at least one signal-measuring electrode configured to measure an impedance signal affected by the injected electrical current and blood flow in the vessel, wherein the current-injecting and signal-measuring electrodes are connected directly to the vessel (see entire document, especially Figure 1, [0019], [0037], [0135]-[0138] delivery and sensing);
Edman teaches a processing system to receive the impedance signal from the impedance system (see entire document, especially Figure 1 140, [0039], [0136]-[0140]), and further comprising an optical system configured to measure optical signals from the vessel (see entire document, especially [0050], [0140] photonic signals/sensing),
wherein the impedance signal is a time-domain waveform (see at least [0137]),
but fails to teach the optical system comprising a light source and a photodetector, wherein the light source is configured to irradiate the vessel with optical radiation and the photodetector is configured to detect the optical radiation after it irradiates the vessel and generate an optical signal; and the processing system configured to receive the optical signal from the optical system, or a signals determined therefrom, and collectively process them to determine a parameter related to the blood flow in the vessel.
Joseph teaches a related system for monitoring vessel features with physiological sensors in direct contact with vessels, and teaches at least one light source and at least one photodetector and reasonably teaches the optical system comprising a light source and a photodetector, with the light source configured to irradiate the vessel with optical radiation and the photodetector configured to detect the optical radiation after it irradiates the vessel and generate an optical signal; and the processing system configured to receive the optical signal from the optical system, or a signals determined therefrom, and collectively process them to determine a parameter related to the blood flow in the vessel (see at least Figures 1-5, [0028]). By including both processing of impedance and light together or as claimed “collectively”, each teaching reference would naturally determine the blood flow related parameters as taught in each reference and meets the claimed limitations under a broadest reasonably interpretation. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine prior art elements according to known methods to yield predictable results of including light sensing elements in order to sense photonic information as suggested in combination with impedance by Edman, and in order to measure blood flow photonically.
While Edman teaches that circuit module can be implanted or can be external to the body to process physiological signals by way of percutaneous wire connections which teaches structures adapted to connect to the at least one of the current-injecting and signal-measuring electrodes (see entire document, especially [0039]), but there is no mention of the structure of external placement to teach the limitations of wherein the impedance system further comprises a body-worn patch, and the feature of wherein a frequency of the electrical current ranges from 5-500kHz is not taught.
Halac teaches a related system for measuring different physiological signals, including impedance (see [0070]), and teaches that a medical device can be a multisensory patch to determine desired physiological data, which reasonably teaches a body-worn patch (see [0070]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine prior art elements according to known methods to yield predictable results of including a patch containing the external components of a medical system in order to secure an external portion to a patient during use by way of a known patch design.
Patil teaches a related system for measuring vessel lumen information including inside or outside the lumen (see title abstract, [0167]), and teaches that impedance can be measured at a wide range of frequency as desired (see at least Figures 2-4), where such injected current can include any desired frequency across 100Hz to 100Mhz which meets the claimed range from 5-5000kHz (see at least Figures 2-4, [0164], [0171]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use whatever injecting current frequency was desired in known ranges in order to measure impedance. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) In re Bergen, 120 F.2d 329, 332, 49 USPQ 749, 751-52 (CCPA 1941).
Response to Arguments
The examiner acknowledges applicant’s submission of amendments to the claims, drawings, and specification filed 1/8/2026.
Applicant’s arguments the drawing and specification objections have been fully considered and are persuasive due to the amendments; the objections are withdrawn.
Applicant’s arguments regarding the rejections of the claims under 35 U.S.C. 112 have been fully considered and are partially persuasive due to the amendments to the claims; however, applicant’s untracked amendments to the claims have introduced new rejections as presented above.
Applicant’s arguments regarding the rejections of the claims in view of prior art have been fully considered but are not persuasive and are moot in view of the new grounds of rejections as the claimed range lies within the prior art known ranges of impedance which supports prima facie obviousness. The rejections are respectfully maintained as presented above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL R BLOCH whose telephone number is (571)270-3252. The examiner can normally be reached M-F 11-8 EST.
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/MICHAEL R BLOCH/Primary Examiner, Art Unit 3791