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.
Election/Restrictions
Applicant’s election with traverse of Groups I and III (claims 1-21, 26, and 27) in the reply filed on 03/13/2026 is acknowledged. Although election of two groups is impermissible, Applicant has amended Group I to include the features of Group III. Group III is therefore no longer independent or distinct. As such, the restriction requirement between Groups I and III is withdrawn, while the restriction requirement between Groups I/III and II is maintained. Applicant has made no species election (which is also impermissible). However, the Office has reconsidered the requirement for an election, and it is hereby withdrawn. In light of this, claims 18 and 19 are not withdrawn from consideration.
The requirement for an election between Groups I/III and II, as consistent with the above, is still deemed proper and is therefore made FINAL.
Claims 22-25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Accordingly, claims 1-21, 26, and 27 are currently under consideration.
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, 6, and 27 are objected to because of the following informalities:
Regarding claim 1, there should be an “and” at the end of line 6 to indicate that what follows is the last element of the system.
Regarding claim 6, the recitation of “frequency sampling” should instead read –sampling frequency--.
Regarding claim 27, the recitation of “different in volume” should instead read –difference in volume--.
Appropriate correction is required.
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: “an electronic device” in claims 1, 11, 12, 26, and 27, and “an external processing unit” in claim 27.
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 1-21, 26, and 27 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 1, there is insufficient antecedent basis for the recitation of “the system” in line 2. The claim is directed to a device.
Further regarding claim 1, antecedent basis for the recitation of “a body portion” in line 6 is unclear, since line 3 already recites a body portion.
Further regarding claim 1, there is insufficient antecedent basis for the recitation of “the wire open loop.”
Regarding claim 7, it is unclear whether the recitation of “the area” refers to the first or the second area.
Regarding claim 8, the recitation of “the area defined by the wire” is unclear at least because of unclear antecedent basis (e.g. does “the area” refer to the first or second area). It may be helpful for Applicant to define the first wire and the first area in e.g. claim 1.
Regarding claim 15, it is unclear how one can select e.g. only one of apnea, sleep apnea, and stress related apnea, since “apnea” covers all apneas.
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. Further, it is unclear how these are “heart activities.”
Regarding claim 20, the recitation of “wires having an inductance varying between 76 nH and 4.4 μH” is unclear. Does the particular wire have that entire inductance range (i.e., does its inductance vary across that entire specific range) as it is stretched and contracted? Or does the range indicate what kinds of wires are contemplated (e.g. wires having an inductance of 1 μH or 4 μH)? This is unclear firstly at least because no condition of stretching and contracting is recited, in which case the inductance of the wire would not vary. Further, it is unclear how one wire would exhibit such a range, since if it were adapted for a child, the range would not reach 4.4 μH (based on ¶ 0064 of the specification as filed - the body radius could not change from 3 cm to 50 cm only due to breathing), and if it were adapted for an adult, the range would not reach 76 nH.
Regarding claim 26, antecedent basis for the recitation of “a body portion” is unclear, since one has already been previously recited.
Claims 2-21, 26, and 27 are rejected because they depend on rejected claims.
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, 5, 7-12, 14, 15, 17-21, 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”).
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 system comprising: a wearable garment being configured to fit a body portion of the wearer (Figs. 1, 4, and 5); a wire supported by or embedded into the garment, the wire being configured to define an area over a body portion of the wearer, the area expanding and shrinking as a result of an expansion or shrinking of a 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); an electronic device supported by or fixed on the garment comprising an oscillator connected to the wire open loop (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 wire (¶¶s 0041, 0042) … as a function of the expansion or shrinking of the area defined by the wire (see above), the electronic device converting 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).
Regarding claim 2, Tobola-Austin teaches all the features with respect to claim 1, as outlined above. Tobola-Austin further teaches the wearable garment comprising an opening and the wire defining the area 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 teaches all the features with respect to claim 1, as outlined above. Tobola-Austin further teaches the wire forming an upper segment defining an upper periphery of the area, a lower segment defining a lower periphery of the area and side segments defining side peripheries of the 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 5, Tobola-Austin teaches all the features with respect to claim 1, as outlined above. Tobola-Austin further teaches a second wire supported by or embedded into the garment, the second wire being configured to define a second area, the second area expanding or shrinking as a result of an expansion or shrinking of a second body portion of the wearer, the second wire being connected to the oscillator (Tobola: Figs. 4 and 5, conductors 42 and 54).
Regarding claim 7, Tobola-Austin teaches all the features with respect to claim 5, as outlined above. Tobola-Austin further teaches each of the two wires comprising an upper segment defining an upper periphery of the area, a lower segment defining a lower periphery of the area and side segments defining side peripheries of the area (Tobola: Figs. 1, 4, and 5, with e.g. Fig. 4 showing an upper segment defined by the top of either of the oscillations, a lower segment defined by the bottom of either of the oscillations, and side segments defined by line ends 12-A/12-B and 42-A/42-B).
Regarding claim 8, Tobola-Austin teaches all the features with respect to claim 5, as outlined above. Tobola-Austin further teaches the area defined by the 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).
Regarding claim 9, Tobola-Austin teaches all the features with respect to claim 5, as outlined above. Tobola-Austin 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 teaches all the features with respect to claim 5, as outlined above. Tobola-Austin further teaches wherein the body portion is the torso of the wearer, the wire defining the first area being substantially placed over a thoracic section of the torso and the second wire defining an 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 teaches all the features with respect to claim 1, as outlined above. Tobola-Austin further teaches wherein the electronic device 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 teaches all the features with respect to claim 1, as outlined above. Tobola-Austin further teaches wherein the electronic device is in communication with a smart phone or a computer using a wireless connection (Tobola: ¶ 0061).
Regarding claim 14, Tobola-Austin teaches all the features with respect to claim 1, as outlined above. Tobola-Austin 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 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, sleep apnea, stress related 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 teaches all the features with respect to claim 1, as outlined above. Tobola-Austin 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 teaches all the features with respect to claim 17, as outlined above. Tobola-Austin 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 teaches all the features with respect to claim 1, as outlined above. Tobola-Austin further teaches the wire being selected from wires having an inductance varying 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 varying 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). Additionally, the particular range in which the inductance of the wire varies is a results-effective variable, as shown in Austin (¶ 0054), 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 the inductance range of the wire based on the number of turns and length of the coil as described in Austin)).
Regarding claim 21, Tobola-Austin teaches all the features with respect to claim 1, as outlined above. Tobola-Austin further teaches the area being a band shaped as a C (Tobola: Figs. 1, 4, and 5, with the break in the band (which defines the C) being at the line ends 12-A/12-B and 42-A/42-B).
Regarding claim 26, Tobola-Austin teaches all the features with respect to claim 1, as outlined above. Tobola-Austin further teaches wherein the wire is configured to form a loop around a 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 device 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 compare the volume measured at the second point in time with 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 teaches all the features with respect to claim 1, as outlined above. Tobola-Austin further teaches the electronic device being in communication with an external processing unit 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 in view of US Patent Application Publication 2018/0317814 (“Nurkka”).
Regarding claim 4, Tobola-Austin teaches all the features with respect to claim 3, as outlined above. Tobola-Austin 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).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Tobola-Austin in view of US Patent Application Publication 2006/0045126 (“Klahn”).
Regarding claim 6, Tobola-Austin teaches all the features with respect to claim 5, as outlined above. Tobola-Austin does not appear to explicitly teach the oscillator being configured to be turned on and off a plurality of times per second according to a frequency sampling.
Klahn teaches adaptively selecting oscillator frequencies and sampling frequencies (¶ 0013).
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 cycle the oscillator of Tobola on and off based on a desired sampling frequency, as in Klahn, thereby minimizing the sampling frequency for the purpose of reducing power consumption of the ADC of the evaluation electronics 16 of Tobola (Klahn: ¶ 0013; Tobola: ¶ 0059).
Claims 13 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Tobola-Austin in view of International Patent Application Publication WO 2013/134856 (“Fournier”).
Regarding claim 13, Tobola-Austin teaches all the features with respect to claim 1, as outlined above. Tobola-Austin 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 teaches all the features with respect to claim 1, as outlined above. Tobola-Austin does not appear to explicitly teach one or more sensors to measure one or more metrics to detect and characterize heart activities 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).
Conclusion
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/ANDREY SHOSTAK/Primary Examiner, Art Unit 3791
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