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 . 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 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.
Response to Amendment
This Office Action is responsive to the amendment filed 07/21/2026 (“Amendment”). Claims 1-4, 6, 8-20, 26, and 27 are currently under consideration. The Office acknowledges the amendments to claims 1-3, 6, 8-12, 15, 16, 20, 26, and 27, as well as the cancellation of claims 5, 7, and 21. Claims 22-25 remain withdrawn.
The objection(s) to the drawings, specification, and/or claims, the interpretation(s) under 35 USC 112(f), and/or the rejection(s) under 35 USC 101 and/or 35 USC 112 not reproduced below has/have been withdrawn in view of the corresponding amendments.
Information Disclosure Statement
Applicant is reminded of the continuing obligation under 37 CFR 1.56, to timely apprise the Office of any information which is material to patentability of the claims under consideration in this application.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claims 1 and 3 are objected to because of the following informalities:
Regarding claim 1, the “and” at the end of line 7 should be deleted.
Regarding claim 3, the recitation of “anyone” should instead read --any one--.
Appropriate correction is required.
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 10 and 16 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 pre-AIA the applicant regards as the invention.
Regarding claim 10, the recitation of “a second area” is unclear since one has already been recited. Is reference being made to the same or a new/different second area?
Regarding claim 16, it is unclear how one can select e.g. only one of body movements and body activities, since one contemplates the other.
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.
Claims 1-3, 6, 8-12, 14, 15, 17-20, 26, and 27 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication 2010/2086546 (“Tobola”) in view of US Patent Application Publication 2008/0183095 (“Austin”) and US Patent Application Publication 2002/0032386 (“Sackner”).
Regarding claim 1, Tobola teaches [a] wearable device for extracting physiological parameters of a wearer by measuring at least one plethysmographic signal (¶¶s 0014 and 0017 describe the measurement of a change in volume of an organ or body part), the wearable device comprising: a wearable garment being configured to fit a body portion of the wearer (Figs. 1, 4, and 5); a first conductive wire supported by or embedded into the garment, the first conductive wire forming a first C-loop defining a first area over the body portion of the wearer (Figs. 1, 4, and 5, with the break in the band (which defines the C) being at e.g. the line ends 12-A/12-B), the first area expanding and shrinking as a result of an expansion or shrinking of the body portion of the wearer (Figs. 1, 4, and 5, electric conductors 12, 42, 52, and/or 54 – also see ¶¶s 0033, 0037, 0041, etc., expanding and contracting to obtain measurements based e.g. on respiratory movement of the thorax); and a second conductive wire supported by or embedded into the garment, the second conductive wire forming a second C-loop defining a second area over the body portion of the wearer (Figs. 1, 4, and 5, with the break in the band (which defines the C) being at e.g. the line ends 42-A/42-B), the second area expanding and shrinking as a result of an expansion or shrinking of the body portion of the wearer (Figs. 1, 4, and 5, the other of electric conductors 12, 42, 52, and/or 54 – also see ¶¶s 0033, 0037, 0041, etc., expanding and contracting to obtain measurements based e.g. on respiratory movement of the thorax); and an electronic circuit supported by or fixed on the garment comprising: an oscillator connected to the first and second conductive wires (Figs. 1 and 5, evaluation electronics 16, described in ¶ 0054 as having a Colpitts oscillator - also see ¶ 0041); …; wherein the oscillator is configured to extract the plethysmographic signal measured by the first and second conductive wires (¶¶s 0041, 0042) … as a function of the expansion or shrinking of the first and second areas defined by the first and second conductive wires (see above), the electronic circuit being configured to convert analog information measured by the oscillator into digital analyzable information (¶ 0059).
Tobola does not appear to explicitly teach extracting the signal at a predetermined frequency.
Austin teaches a tunable oscillator base frequency within the range of e.g. 10 kHz and 10 GHz, and typically within a range of between about 2 MHz and about 5 MHz (¶ 0062). Austin further teaches that this frequency can be configured as desired or convenient, including in the case of a Colpitts oscillator (¶¶s 0062, 0063).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a predetermined frequency with the Colpitts oscillator of Tobola, as in Austin (e.g. 1.5 MHz to 15 MHz), for the purpose of minimizing interference with other devices commonly found in residential or commercial settings (Austin: ¶ 0062). Additionally, the particular frequency or frequency band is a results-effective variable, as shown in Austin (¶ 0062), and it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges through routine experimentation is not inventive (choosing a particular frequency in e.g. the 10 kHz to 10 GHz band as described in Austin). In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Tobola-Austin does not appear to explicitly teach the electronic circuit comprising a switching circuit configured to alternatively activate the first conductive wire and the second conductive wire at a predetermined switching frequency such that only one of the two conductive wires is active at a time to limit electromagnetic interference between the first area and the second area.
Sackner teaches using a switching circuit to alternatively activate different wires according to a predetermined switching frequency (Figs. 6 and 7, ¶¶s 0134, 0135, 0142, etc., sequentially sampling the switched osc blocks according to a clock).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate sequential sampling into the combination as in Sackner, as a known means for processing the plethysmographic signals (Sacker: ¶ 0134), including signals from multiple loops (Sackner: ¶ 0138), to thereby enable/improve non-invasive and ambulatory monitoring (Sackner: ¶ 0023).
Regarding claim 2, Tobola-Austin-Sackner teaches all the features with respect to claim 1, as outlined above. Tobola-Austin-Sackner further teaches the wearable garment comprising an opening and the first and second conducive wires defining the first and second areas without intersecting the opening (Tobola: Figs. 1, 4, and 5, e.g. the neck opening at the top of the shirt).
Regarding claim 3, Tobola-Austin-Sackner teaches all the features with respect to claim 1, as outlined above. Tobola-Austin-Sackner further teaches anyone of the first and second conductive wires forming an upper segment defining an upper periphery of the first or second area, a lower segment defining a lower periphery of the first or second area and side segments defining side peripheries of the first or second area (Tobola: Figs. 1, 4, and 5, with e.g. Fig. 4 showing an upper segment defined by the top oscillations (or the top of the top oscillations), a lower segment defined by the bottom oscillations (or the bottom of the bottom oscillations), and side segments defined by line ends 12-A and 12-B).
Regarding claim 6, Tobola-Austin-Sackner teaches all the features with respect to claim 1, as outlined above. Tobola-Austin-Sackner further teaches the oscillator being configured to be turned on and off a plurality of times per second according to a sampling frequency (Sackner: ¶ 0142, the switch and clock achieving a sampling frequency).
Regarding claim 8, Tobola-Austin-Sackner teaches all the features with respect to claim 1, as outlined above. Tobola-Austin-Sackner further teaches the first area defined by the first wire overlapping with the second area defined by the second wire (Tobola: as in Figs. 4 and 5 – all areas are areas of the torso or upper body).
Regarding claim 9, Tobola-Austin-Sackner teaches all the features with respect to claim 1, as outlined above. Tobola-Austin-Sackner further teaches at least one connector embedded into the wearable garment for connecting the oscillator to each of the wires (Tobola: e.g. line ends 12-A/12-B and 42-A/42-B of Fig. 4, having comparable components in Fig. 5 - also see e.g. ¶ 0005, describing the electrical conductors as integrable into the garment, and see ¶ 0035).
Regarding claim 10, Tobola-Austin-Sackner teaches all the features with respect to claim 1, as outlined above. Tobola-Austin-Sackner further teaches wherein the body portion is the torso of the wearer, the first wire defining the first area being substantially placed over a thoracic section of the torso and the second wire defining a second area over an abdominal section of the wearer (Tobola: as shown in Figs. 4 and 5); the first and second areas being configured to measure a breathing frequency and/or a frequency change of the wearer (Tobola: ¶ 0017, breathing frequency).
Regarding claim 11, Tobola-Austin-Sackner teaches all the features with respect to claim 1, as outlined above. Tobola-Austin-Sackner further teaches wherein the electronic circuit comprises a central processing unit (CPU) configured to execute instructions for converting analog information into digital information by applying at least one algorithm to analyze the information (Tobola: ¶¶s 0059, 0052 – also see Austin: ¶¶s 0043 and 0045, describing a processor that is configured to execute instructions (integrable in the detector 108 itself). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a CPU into the electronic device of Tobola, as in Austin, for the purpose of being able to execute a variety of instructions (Austin: ¶ 0043)).
Regarding claim 12, Tobola-Austin-Sackner teaches all the features with respect to claim 1, as outlined above. Tobola-Austin-Sackner further teaches wherein the electronic circuit is in communication with a smart phone or a computer using a wireless connection (Tobola: ¶ 0061).
Regarding claim 14, Tobola-Austin-Sackner teaches all the features with respect to claim 1, as outlined above. Tobola-Austin-Sackner further teaches wherein the physiological parameters extracted by the device are one or more breathing metrics selected from the group consisting of respiratory rate, tidal volume, minute ventilation and fractional inspiratory time (Tobola: ¶ 0017 describes breathing frequency, breathing depth, breathing volume, etc.).
Regarding claim 15, Tobola-Austin-Sackner teaches all the features with respect to claim 1, as outlined above. Tobola does not appear to explicitly teach one or more sensors to measure one or more metrics to detect and characterize physical conditions selected from the group consisting of talking, laughing, crying, hiccups, coughing, asthma, apnea, relaxation exercise, breathing cycle symmetry, and pulmonary diseases.
Austin teaches using a belt-like wearable garment to detect and characterize e.g. apnea (Abstract. Also see Fig. 5A, the portion of breathing detector 500 not including sensor osc 504).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the device of Tobola to detect apnea, as in Austin, for the purpose of improving patient monitoring by detecting and warning about potentially dangerous conditions (Austin: Abstract).
Regarding claim 17, Tobola-Austin-Sackner teaches all the features with respect to claim 1, as outlined above. Tobola-Austin-Sackner further teaches the oscillator being a Colpitts oscillator (Tobola: ¶¶s 0041 and 0054) and having an optimal frequency band from 1 MHz to 15 MHz for extracting the plethysmographic signal (as above, Austin teaches a tunable oscillator base frequency within the range of e.g. 10 kHz and 10 GHz, and typically within a range of between about 2 MHz and about 5 MHz (¶ 0062). Austin further teaches that this frequency can be configured as desired or convenient, including in the case of a Colpitts oscillator (¶¶s 0062, 0063). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a Colpitts oscillator with an optimal frequency band in the specified range (1 MHz to 15 MHz), for the purpose of minimizing interference with other devices commonly found in residential or commercial settings (Austin: ¶ 0062)).
Regarding claims 18 and 19, Tobola-Austin-Sackner teaches all the features with respect to claim 17, as outlined above. Tobola-Austin-Sackner further teaches wherein the frequency of the Colpitts oscillator is about 4.3 MHz, wherein the frequency of the Colpitts oscillator is about 5.4 MHz (as above, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a Colpitts oscillator with an optimal frequency band as specified, for the purpose of minimizing interference with other devices commonly found in residential or commercial settings (Austin: ¶ 0062). Additionally, the particular frequency or frequency band is a results-effective variable, as shown in Austin, and it has been held that where the general conditions of a claim are disclosed in the prior art (Austin), discovering the optimum or workable ranges through routine experimentation is not inventive (choosing a particular frequency in e.g. the 10 kHz to 10 GHz band as described in Austin). In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 20, Tobola-Austin-Sackner teaches all the features with respect to claim 1, as outlined above. Tobola-Austin-Sackner further teaches the wire being selected from wires having an inductance between 76 nH and 4.4 μH (Austin: ¶ 0054, its inducting wire can have an inductance ranging from one to about four microhenrys when stretched and contracted. It would have been obvious to use an inducting wire with an inductance between 76 nH and 4.4 μH in the combination, as taught by Austin, for the purpose of achieving desired measures of inductance to accommodate particular variable inductance sensors (Austin: ¶ 0054)).
Regarding claim 26, Tobola-Austin-Sackner teaches all the features with respect to claim 1, as outlined above. Tobola-Austin-Sackner further teaches wherein the first and second conductive wires are each configured to form a loop around the body portion of the wearer of the garment (Tobola: as shown in Figs. 1, 4, and 5 – also see ¶ 0011, etc.), and wherein the electronic circuit is further configured to measure the volume of the body portion of the wearer at least at two points in time, to establish a baseline volume based on the volume measured at the first point in time and to subtract the volume measured at the second point in time from the established baseline to obtain an absolute difference in volume between the two points in time (Tobola: ¶ 0014, change in the volume of the body part – also see ¶¶s 0017, 0044 (deviation), 0050, 0055, Fig. 3, etc.).
Regarding claim 27, Tobola-Austin-Sackner teaches all the features with respect to claim 1, as outlined above. Tobola-Austin-Sackner further teaches the electronic circuit being in communication with an external processor for the calculation of the absolute difference in volume of the person (Austin: ¶ 0043, using a base unit 110 comprising a processor 114 to analyze received data. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to communicate the data of Tobola to an external device for processing, as in Austin, for the purpose of conserving resources on the sensor device itself (Austin: ¶¶s 0013, 0043, etc.)).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Tobola-Austin-Sackner in view of US Patent Application Publication 2018/0317814 (“Nurkka”).
Regarding claim 4, Tobola-Austin-Sackner teaches all the features with respect to claim 3, as outlined above. Tobola-Austin-Sackner does not appear to explicitly teach the wearable garment comprising an opening and the side segments being adjacent to the opening.
Nurkka teaches a wearable garment having an opening defined by a zipper, with side segments of an inductance wire adjacent the zipper (Fig. 15A and related description).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to arrange side segments of the wire adjacent an opening in a wearable garment, as in Nurkka, for the purpose of making the device usable in more types of clothing (Nurkka: ¶¶s 0056-0058, with a zipper), and so that the zipper does not interfere with continuity of the wire (Nurkka: ¶ 0056).
Claims 13 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Tobola-Austin-Sackner in view of International Patent Application Publication WO 2013/134856 (“Fournier”).
Regarding claim 13, Tobola-Austin-Sackner teaches all the features with respect to claim 1, as outlined above. Tobola-Austin-Sackner does not appear to explicitly teach at least one sensor for measuring body temperature, blood pressure and/or heart beat frequency.
Fournier teaches a washable intelligent garment having e.g. a skin temperature sensor thereon (Fig. 14, ¶ 0042).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a body temperature sensor into the combination, as in Fournier, for the purpose of gathering additional diagnostic data to thereby improve patient monitoring (Fournier: ¶ 0042).
Regarding claim 16, Tobola-Austin-Sackner teaches all the features with respect to claim 1, as outlined above. Tobola-Austin-Sackner does not appear to explicitly teach one or more sensors to measure one or more metrics to detect and characterize activities of the wearer selected from the group consisting of heart rate, body movements and body activities.
Fournier teaches a comparable wearable system including one or more sensors to measure e.g. heart rate metrics to characterize heart rate (Figs. 12 and 13).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate additional sensors into the system to detect additional physiological data, for the purpose of enabling more comprehensive monitoring of the patient (Fournier: ¶ 0042).
Response to Arguments
Applicant’s arguments filed 07/21/2026 have been fully considered. In response to the amendment to claim 16, it is unclear how reciting “activities of the wearer” resolves the ambiguity of measuring more than one metric of “body movements and body activities.”
In response to the arguments regarding the rejections under 35 USC 103, they are persuasive. Therefore, a new grounds of rejection is made in further view of Sackner, and all claims remain rejected in light of the prior art.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREY SHOSTAK whose telephone number is (408) 918-7617. The examiner can normally be reached Monday - Friday 7 am - 3 pm.
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/ANDREY SHOSTAK/Primary Examiner, Art Unit 3791