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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 08/11/2025 has been entered.
Response to Arguments
Applicant’s arguments, see pages 7-10, filed 08/11/2025, with respect to the rejection(s) of the claim(s) under 35 U.S.C. 103 have been fully considered. Amendments obviate the rejection of record.
Applicant argues on pages 6-8 that “Kruger fails to disclose processing these signals in combination or functionally coordinating them for arrhythmia detection. Mere parallel acquisition is insufficient… nowhere in Kruger is there a teaching or suggestion that ECG and IMU signals are processed in combination for arrhythmia detection, nor is there any disclosure of diagnostic interpretation, rhythm classification, or waveform analysis consistent with arrhythmia detection… The mere inclusion of “arrhythmia” in a speculative list does not constitute an enabling disclosure, nor does it teach or suggest the claimed signal processing for arrhythmia detection.” Examiner agrees as amendments obviate the rejection of record.
Applicant then argues on page 9 that “Mrvaljevic does not teach or suggest that the textile enclosure itself is configured to mechanically and electrically interconnect the controller to the one or more conductive fibres that connect to the sensor panel… Applicant respectfully disagrees that the claimed mechanical and electrical interconnection is inherently disclosed. Mrvaljevic does not describe any specific structural features of the pocket (e.g., contact pads, docking terminals) that enable automatic electrical interconnection with the controller… This language clearly establishes that the pocket is intended to hold or store the controller, i.e., provide mechanical containment. However, there is no disclosure of any electrical interface within the pocket; no contact pads, conductive leads, or alignment features are described to ensure automatic electrical interconnection upon insertion; and there is no mention of the pocket playing a role in completing or bridging an electrical circuit between the controller and sensors… While this indicates that signal pathways exist somewhere within the garment, it does not specify where or how those conductive elements terminate at the pocket. Specifically, there is no mention of the conductive thread terminating within or at the inner wall of the controller pocket. Additionally, there is no disclosure that the pocket itself includes electrical contacts to engage with matching contacts on the controller. None of the embodiments in Mrvaljevic describe a docking mechanism where electrical continuity is established through passive insertion into the textile enclosure.” Examiner disagrees. The phrase “textile enclosure” which is configured to electrically and mechanically interconnect the controller device to the conductive fibres, is an intended use of the structure of the textile enclosure. Thus, the textile enclosure configured for any functional usage would be an inherent function of the structure of the “textile enclosure”. However, the “textile enclosure” fails to have an associated structure in the instant specification. As the instant specification fails to structurally define the “textile enclosure”, Examiner can establish a broadest reasonable interpretation of the phrase, which is noted in the final office action dated 06/11/2025, on page 5 to be the pocket, which would have the intended use/function of electrically and mechanically interconnect the controller device to the conductive fibres. For this reason alone, Applicant’s arguments are moot because since there is no structure for the textile enclosure, any intended use/function is thereby ambiguous and unclear. Nevertheless, for the sake of argument, as established by the Applicant on page 9, the pocket, as identified by the Examiner as the textile enclosure, provides mechanical containment (page 9 of the remarks filed on 08/11/2025), and because [0032 of Mrvaljevic establishes the electrical connectiuon between the controller and the sensors, there inherently is a connection with the conductive fibres. Examiner also notes that claim does not require any electrical contacts, conductive elements, or a docking mechanism that terminates at the pocket.
Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Mrvaljevic et al. (US 20190290181) (Hereinafter Mrvaljevic) in view of Wang et al. (US 20180146922) (Hereinafter Wang).
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:
“Textile enclosure” in line 19 of claim 1 and 11. The instant specification fails to provide structure as to what the “textile enclosure” may be, but describes “textile enclosure” to be a cavity that is knitted to the garment sleeve and receives the controller device and electrically and mechanically connects the controller to the sensors (Pages 21-22 of the instant specification). Examiner will interpret the “textile enclosure” as a cavity that receives the controller device. The textile enclosure is integrated into the garment.
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 the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 21-39 are rejected under 35 U.S.C. 112, first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
Claim 21 has been amended to include the limitation, " a controller device configured to process both of a signal from the biosensor and ECG signals from the ECG sensors in combination to detect a cardiac health event of the user, the cardiac health event comprising an arrhythmia ". The limitation does not have support in the instant specification nor in the parent application.
The specification provides support on pages 23 of the instant specification for “may estimate heart rate and detect arrhythmias based on bio signal data received from at least one of the ECG sensors, BCG sensors, PPG sensors, or other bio signal sensor types”. However, the specification does not provide support for both sensor signals used to detect an arrhythmia in combination. Specifically, while this sentence from the instant specification on page 23 suggests that more than one sensor can be used, it does not provide enough support for the combination of ECG and biosensor signals for determining arrhythmia. Applicant has not indicated where the disclosure provides adequate written description support for the instant claim limitation, "a controller device configured to process both of a signal from the biosensor and ECG signals from the ECG sensors in combination to detect a cardiac health event of the user, the cardiac health event comprising an arrhythmia”. Therefore, the new claim limitations introduce new matter.
Claims 21-41 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Similarly, original claims may lack written description when the claims define the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or the result is achieved. For software, this can occur when the algorithm or steps/procedure for performing the computer function are not explained at all or are not explained in sufficient detail (simply restating the function recited in the claim is not necessarily sufficient). In other words, the algorithm or steps/procedure taken to perform the function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed. See MPEP §§ 2163.02 and 2181, subsection IV.
Merely recite a description of the problem to be solved while claiming all solutions to it, leaving the industry to “complete an unfinished invention.” See Ariad, 598 F.3d at 1353
Disclosure of function alone is little more than a wish possession. See MPEP 2163(II)(A)(3)(a).
The written description requirement is not satisfied by merely outlining the goals or results one hopes to achieve with the invention. See MPEP 2163(II)(A)(3)(a).
Claim 21 fails to sufficiently describe the process both biosensor signal and ECG signal in combination for detecting an arrhythmia to show possession of the claimed invention. Claims 40-41 fail to sufficiently describe the processing of a signal from biosensor signal and ECG signal for detecting an arrhythmia to show possession of the claimed invention. The mere statement and recitation of “process both of a signal from the biosensor and ECG signals from ECG sensors in combination to detect a cardiac health event of the user, the cardiac health event comprising an arrhythmia” in claim 21 and pages 23 of the instant specification discloses “may estimate heart rate and detect arrhythmias based on bio signal data received from at least one of the ECG sensors, BCG sensors, PPG sensors, or other bio signal sensor types” fails to establish how the processing of both ECG and biosensor signal achieves the arrythmia. The instant specification provides insufficient detail to the calculations required to be done to the biosensor signals and ECG and all the steps in between to reach the conclusion of an arrythmia. The instant specification lacks crucial steps, requiring a large leap in faith, to jump from ECG and bio signals combined to reach the end goal of determining an arrythmia. The instant specification fails to provide details as to what within the biosignal waveforms and ECG (e.g. peaks, intervals, or time delays) are looked at to determine arrythmia. Therefore, claims 21-41 do not provide sufficient detail for having sufficient written description.
Claims 21, 40, and 41 fail to sufficiently describe the structure for “textile enclosure” to show possession of the claimed invention. The mere statement and recitation of “textile enclosure” in claims 21, 40, and 41 and pages 21-22 of the instant specification that the textile enclosure being a cavity that projects from the sleeve fails to provide structure for the textile enclosure, other than their mere description of their respective function. Regarding the textile enclosure, it is unknown how a defined cavity (which appears to the textile enclosure, thereby not being a structural component) can be projecting from the garment while also being a knitted textile material for receiving the controller. It is unclear what the structure that makes up the textile enclosure that allows it to shapeshift between the knitted garment sleave while also defining a cavity and projecting from the garment. Therefore, claims 21-41 do not provide sufficient detail for having sufficient written description of the structural components of “textile enclosure”.
Claims 21-41 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification does not reasonably provide enablement for the determining of arrhythmia from ECG signals and any biosensor signal in combination. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, for using any biosensor signal and ECG signals for arrythmias.
In making a determination as to whether an application has met the requirements for enablement under 35 U.S.C. 112(a), the following factors enumerated In re Wands, 8 USPQ2d 1400, at 1404 (CAFC 1988) are considered:
(1) the breadth of the claims,
(2) the amount of direction or guidance presented, (3) the presence or absence of working examples,
(4) the nature of the invention,
(5) the state of the prior art,
(6) the relative skill of those in the art,
(7) the predictability or unpredictability of the art, &
(8) the quantity of experimentation necessary.
While it is not essential that every factor be examined in detail, those factors deemed most relevant should be considered.
The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. Taking into account the factors discussed in MPEP 2164.01 (a), there is insufficient guidance and direction for one of ordinary skill in the art to make and use a single biosensor signal used in combination of an ECG for determining arrhythmia . The nature of the invention is highly technical, and the level of predictability in the art is low, as the combining of ECG and biosensor signal for determining arrhythmia lacks sufficient working examples in the instant specification.
Absence of Working Examples/The Amount of Direction
In view of the absence of a specific and detailed description in Applicant’s specification of how to effectively use the method as claimed, and absence of working examples providing evidence which is reasonably predictive that the claims 21-41 would work, and the lack of predictability in the art at the time the invention was made, an undue amount of experimentation would be required to practice the claimed methods with a reasonable expectation of success. Although the instant specification merely states that “may estimate heart rate and detect arrhythmias based on bio signal data received from at least one of the ECG sensors, BCG sensors, PPG sensors, or other bio signal sensor types” (Page 23), the specification makes no mention of combining the ECG and biosensor signal for determining arrhythmia. The specification fails to explain how the combination and what within the signals are used to determine the arrhythmia. As such, the Examiner believes the quantity of experimentation needed to make and use the invention based on the lack of content in the disclosure would be high.
Taking all of the factors into consideration leads to a conclusion that there is no enablement for the limitations discussed above. The dependent claims also lack enablement based on their association with claims 21-41.
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 40-41 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.
Regarding claims 40-41, it is unclear how “a signal” from a biosignal signal and ECG signal is used to detect an arrythmia. In other words, it is unclear how two separate signals equate to a single signal used for detecting arrhythmia. Examiner interprets the signal to mean one of either the ECG or biosignal sensor signals used for detecting arrhythmia.
Claim limitation “textile enclosure” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. It is unclear what the textile enclosure may be; specifically, how a defined cavity (which appears to the textile enclosure, thereby not being a structural component) can be projecting from the garment. It is unclear what is defining a cavity and projecting from the garment. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
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.
Claim(s) 40-41 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mrvaljevic et al. (US 20190290181) (Hereinafter Mrvaljevic) in view of Kruger et al. (US 20180311530) (Hereinafter Kruger).
Regarding claims 40, and 41, Mrvaljevic teaches A smart garment for detecting physiological data/A method for detecting physiological data using a smart garment ([0031] “the controller 125 can be embedded within the athlete's clothing, such as a shirt 445a and pants 445b (collectively “clothing 445”).”), the smart garment comprising:
a garment configured to be worn on an upper body of a user (Fig. 4B);
a first garment portion having a primary sensor panel having a first sensor type, the first sensor type being an ECG sensor ([0032] “the controller 125 is operably coupled to electrocardiogram (ECG) sensors 423a, electromyography (EMG) sensors 423b, an orientation sensor 423c (FIG. 4A; e.g., a gyroscope), and an acceleration sensor 423d (FIG. 4A; e.g., an accelerometer) that are carried at various locations on the athlete's clothing 445.” Fig. 4B (Position LA 423A [ECG sensor]));
a second garment portion having a complementary sensor panel, the complementary sensor panel including a complementary ECG sensor and a biosensor of a second sensor type different from the first sensor type ([0032] “the controller 125 is operably coupled to electrocardiogram (ECG) sensors 423a, electromyography (EMG) sensors 423b, an orientation sensor 423c (FIG. 4A; e.g., a gyroscope), and an acceleration sensor 423d (FIG. 4A; e.g., an accelerometer) that are carried at various locations on the athlete's clothing 445.” Fig. 4B (Position RA 423A [ECG sensor] and 423B[EMG sensor]));
one or more conductive fibres configured to electrically interconnect the primary sensor panel, the complementary sensor panel, and the controller device ([0032] “The sensors 423 can be connected to the controller 125 using thin, resilient flexible wires (not shown) and/or conductive thread (not shown) woven into the clothing 445.”); and
wherein the garment comprises a textile enclosure configured to removably receive the controller device, the textile enclosure configured to electrically and mechanically interconnect the controller device to the one or more conductive fibres ([0031] “the controller 125 can be inserted into a pocket 443 [textile enclosure] in the user's clothing and/or attached using Velcro, snap, snap-fit buttons, zippers, etc. In some embodiments, the controller 125 can be removable from the clothing 445, such as for charging the controller 125.” [0032] “The sensors 423 can be connected to the controller 125 using thin, resilient flexible wires (not shown) and/or conductive thread (not shown) woven into the clothing 445.” Mrvaljevic further teaches in [0031] that the controller 125 is removeable, which means that the controller must be mechanically connected (physical connected to the wires) while also electrically connected to the sensors vis the wires.).
Mrvaljevic does not teach an accelerometer and ECG for detecting movement in the primary sensor panel to detect arrhythmia. Kruger, in the same field of endeavor, teaches sensors on at different locations of the body of an athlete on a compression shirt (Abstract and Fig. 6), similar to the device of Mrvaljevic, and further teaches a controller device configured to process a signal from the biosensor and ECG signals from the ECG sensors to detect a cardiac health event of the user, the cardiac health event comprising an arrhythmia ([0039] “This data is used primarily for monitoring the heart rate of the user. Other analytics include the estimated respiration rate and monitor abnormalities. These abnormalities include heart attacks, a murmur, seizures, cardiac dysrhythmias, fainting, and other abnormalities. Even though the process searches for key signs in the abnormalities, the main purpose to monitor the heart rate [from ECG data] through the ergonomic or athletic motion [motion data from accelerometer].”) to correlate changes in contractility (Pg. 7 line 6). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention to modify the invention of Mrvaljevic, with the accelerometer and ECG for detecting movement in the primary sensor panel to detect arrhythmia of Kruger, because such a modification would allow to correlate changes in contractility.
Claim(s) 21, 27, and 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mrvaljevic et al. (US 20190290181) (Hereinafter Mrvaljevic) in view of Wang et al. (US 20180146922) (Hereinafter Wang).
Regarding claims 21, Mrvaljevic teaches A smart garment for detecting physiological data/A method for detecting physiological data using a smart garment ([0031] “the controller 125 can be embedded within the athlete's clothing, such as a shirt 445a and pants 445b (collectively “clothing 445”).”), the smart garment comprising:
a garment configured to be worn on an upper body of a user (Fig. 4B);
a first garment portion having a primary sensor panel having a first sensor type, the first sensor type being an ECG sensor ([0032] “the controller 125 is operably coupled to electrocardiogram (ECG) sensors 423a, electromyography (EMG) sensors 423b, an orientation sensor 423c (FIG. 4A; e.g., a gyroscope), and an acceleration sensor 423d (FIG. 4A; e.g., an accelerometer) that are carried at various locations on the athlete's clothing 445.” Fig. 4B (Position LA 423A [ECG sensor]));
a second garment portion having a complementary sensor panel, the complementary sensor panel including a complementary ECG sensor and a biosensor of a second sensor type different from the first sensor type ([0032] “the controller 125 is operably coupled to electrocardiogram (ECG) sensors 423a, electromyography (EMG) sensors 423b, an orientation sensor 423c (FIG. 4A; e.g., a gyroscope), and an acceleration sensor 423d (FIG. 4A; e.g., an accelerometer) that are carried at various locations on the athlete's clothing 445.” Fig. 4B (Position RA 423A [ECG sensor] and 423B[EMG sensor]));
one or more conductive fibres configured to electrically interconnect the primary sensor panel, the complementary sensor panel, and the controller device ([0032] “The sensors 423 can be connected to the controller 125 using thin, resilient flexible wires (not shown) and/or conductive thread (not shown) woven into the clothing 445.”); and
wherein the garment comprises a textile enclosure configured to removably receive the controller device, the textile enclosure configured to electrically and mechanically interconnect the controller device to the one or more conductive fibres ([0031] “the controller 125 can be inserted into a pocket 443 [textile enclosure] in the user's clothing and/or attached using Velcro, snap, snap-fit buttons, zippers, etc. In some embodiments, the controller 125 can be removable from the clothing 445, such as for charging the controller 125.” [0032] “The sensors 423 can be connected to the controller 125 using thin, resilient flexible wires (not shown) and/or conductive thread (not shown) woven into the clothing 445.” Mrvaljevic further teaches in [0031] that the controller 125 is removeable, which means that the controller must be mechanically connected (physical connected to the wires) while also electrically connected to the sensors vis the wires.).
Mrvaljevic does not teach an acceleration signal and ECG used in combination to detect arrhythmia. Wang, in the same field of endeavor, teaches a worn garment containing electrodes and accelerometers for collecting ECG and acceleration data (Abstract), and further teaches a controller device configured to process both of a signal from the biosensor and ECG signals from the ECG sensors in combination to detect a cardiac health event of the user, the cardiac health event comprising an arrhythmia ([0042] “electrocardiogram measurements from the electrodes and acceleration measurements from the accelerometer(s) of the garment 210 may be forwarded to a processing apparatus in the server device 240 for analysis using techniques disclosed herein (e.g., the technique 400 of FIG. 4). For example, an alert indicating a cardiac condition of a human wearing the garment 210 may be generated, based on the electrocardiogram measurements from the electrodes and acceleration measurements from the accelerometer(s)… an alert generated by the server device 240 may be forwarded to the garment and may cause a defibrillator integrated with the garment 210 to be activated (e.g., where the alert indicates a ventricular fibrillation condition has been detected for the human wearing the garment 210)”) to provide adequate treatment for the condition based on more accurate results ([0042]). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention to modify the invention of Mrvaljevic, with the acceleration signal and ECG used in combination to detect arrhythmia of Wang, because such a modification would allow to provide adequate treatment for the condition based on more accurate results.
Regarding claim 27, Mrvaljevic teaches wherein the enclosure is disposed on the garment, the enclosure having moisture resistant properties relative to the controller when the controller is received by the enclosure ([0030] “the controller 125 can be packaged in a water-resistant, resilient housing 442 having a small form factor.”).
Regarding claim 30, Mrvaljevic teaches wherein the primary sensor panel and the complementary sensor panel are affixed to a user facing side of the garment ([0033] “The fit of the clothing can be selected to be sufficiently tight to provide continuous skin contact with the individual sensors 423a and 423b, allowing for accurate readings, while still maintaining a high-level of comfort, comparable to that of traditional compression fit shirts, pants, and similar clothing.”).
Claim(s) 24-26, 28, and 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mrvaljevic et al. (US 20190290181) (Hereinafter Mrvaljevic) in view of Wang et al. (US 20180146922) (Hereinafter Wang) and Kruger et al. (US 20180311530) (Hereinafter Kruger).
Regarding claim 24, claim 21 is obvious over Mrvaljevic and Wang. Mrvaljevic does not teach an accelerometer for detecting movement in the primary sensor panel to detect adverse health event. Kruger, in the same field of endeavor, teaches sensors on at different locations of the body of an athlete on a compression shirt (Abstract and Fig. 6), similar to the device of Mrvaljevic, and further teaches further comprising an accelerometer for detecting user movement and/or position ([0029] “200 sensors to calculate the specific 300 movement and 600 performance of an end user, to 805 predict the trajectory of an object. These 200 sensors include from 201 surface electromyography, also referred by SEMG sensors, 201 Electrocardiogram, also referred to by EKG, and 202 Inertial Measurement Units, also referred by IMU sensors, which are a combination of two or more of accelerometers, gyroscopes, magnetometers, and barometers.”) to accurately correlate the motion with the heart rate ([0029]). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention to modify the invention of Mrvaljevic, with the accelerometer for detecting movement in the primary sensor panel to detect adverse health event of Kruger, because such a modification would allow to accurately correlate the motion with the heart rate.
Regarding claim 25, claim 21 is obvious over Mrvaljevic and Wang. Mrvaljevic does not teach an accelerometer for detecting movement in the primary sensor panel to detect adverse health event. Kruger, in the same field of endeavor, teaches sensors on at different locations of the body of an athlete on a compression shirt (Abstract and Fig. 6), similar to the device of Mrvaljevic, and further teaches wherein the primary sensor panel includes the accelerometer (Fig. 6 (202) where the microcontroller 202 includes IMU’s which is an accelerometer. Examiner notes that the electrodes and accelerometers are on a side of the sleeve ([0025] and [0029]).) to accurately correlate the motion with the heart rate ([0029]). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention to modify the invention of Mrvaljevic, with the accelerometer for detecting movement in the primary sensor panel to detect adverse health event of Kruger, because such a modification would allow to accurately correlate the motion with the heart rate.
Regarding claim 26, claim 21 is obvious over Mrvaljevic and Wang. Mrvaljevic does not teach an accelerometer for detecting movement in the primary sensor panel to detect adverse health event. Kruger, in the same field of endeavor, teaches sensors on at different locations of the body of an athlete on a compression shirt (Abstract and Fig. 6), similar to the device of Mrvaljevic, and further teaches wherein the controller device is configured to use accelerometer data to detect an adverse health event ([0039] “This data is used primarily for monitoring the heart rate of the user. Other analytics include the estimated respiration rate and monitor abnormalities. These abnormalities include heart attacks, a murmur, seizures, cardiac dysrhythmias, fainting, and other abnormalities. Even though the process searches for key signs in the abnormalities, the main purpose to monitor the heart rate through the ergonomic or athletic motion.”) to accurately correlate the motion with the heart rate ([0029]). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention to modify the invention of Mrvaljevic, with the accelerometer for detecting movement in the primary sensor panel to detect adverse health event of Kruger, because such a modification would allow to accurately correlate the motion with the heart rate.
Regarding claim 28, claim 21 is obvious over Mrvaljevic and Wang. Mrvaljevic does not teach an controller device detects arrhythmias based on signal data received from at least one of the ECG sensors or one or more BCG sensors. Kruger, in the same field of endeavor, teaches sensors on at different locations of the body of an athlete on a compression shirt (Abstract and Fig. 6), similar to the device of Mrvaljevic, and further teaches wherein the controller device detects arrhythmias based on signal data received from at least one of the ECG sensors or one or more BCG sensors ([0039] “This data is used primarily for monitoring the heart rate of the user. Other analytics include the estimated respiration rate and monitor abnormalities. These abnormalities include heart attacks, a murmur, seizures, cardiac dysrhythmias, fainting, and other abnormalities. Even though the process searches for key signs in the abnormalities, the main purpose to monitor the heart rate through the ergonomic or athletic motion.” The heart rate is obtained from electrodes for collecting ECG.) to accurately correlate the motion with the heart rate ([0029]). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention to modify the invention of Mrvaljevic, with the controller device detects arrhythmias based on signal data received from at least one of the ECG sensors or one or more BCG sensors of Kruger, because such a modification would allow to accurately correlate the motion with the heart rate.
Regarding claim 34, claim 21 is obvious over Mrvaljevic and Wang. Mrvaljevic does not teach an health event as an adverse health event is one of arrythmia, fainting, heart attack, and/or stroke. Kruger, in the same field of endeavor, teaches sensors on at different locations of the body of an athlete on a compression shirt (Abstract and Fig. 6), similar to the device of Mrvaljevic, and further teaches wherein the health event as an adverse health event is one of arrythmia, fainting, heart attack, and/or stroke ([0039] “This data is used primarily for monitoring the heart rate of the user. Other analytics include the estimated respiration rate and monitor abnormalities. These abnormalities include heart attacks, a murmur, seizures, cardiac dysrhythmias, fainting, and other abnormalities. Even though the process searches for key signs in the abnormalities, the main purpose to monitor the heart rate through the ergonomic or athletic motion.”) to accurately correlate the motion with the heart rate ([0029]). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention to modify the invention of Mrvaljevic, with the health event as an adverse health event is one of arrythmia, fainting, heart attack, and/or stroke of Kruger, because such a modification would allow to accurately correlate the motion with the heart rate.
Claim(s) 22 and 31-32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mrvaljevic et al. (US 20190290181) (Hereinafter Mrvaljevic) in view of Wang et al. (US 20180146922) (Hereinafter Wang) and Wong et al. (US 20200281484) (Hereinafter Wong).
Regarding claim 22, claim 21 is obvious over Mrvaljevic and Wang. Mrvaljevic in view of Wang does not teach an ECG and a BCG/PPG for PTT. Wong, in the same field of endeavor, teaches a wearable garment with ECG, BCG and PPG sensors configured to worn by an individual (Abstract), similar to the device of Mrvaljevic, and further teaches wherein the controller device is configured to use data collected by the ECG sensors and at least one of a BCG sensor and/or a PPG sensor to determine at least one of: pulse arrival time (PAT), the preejection period (PEP), ventricular electromechanical delay (VEMD), and/or pulse transit time (PTT) ([0058] “The ECG tells when a heartbeat takes place, while the PPG on each bicep shows how long does it take for the surge of blood to travel from the heart to the respective bicep, i.e. the pulse-transit-time to the bicep.”) to monitor health events at different parts of the body ([0059]). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention to modify the invention of Mrvaljevic, with the ECG and a BCG/PPG for PTT of Wong, because such a modification would allow to monitor health events at different parts of the body.
Regarding claim 31, claim 21 is obvious over Mrvaljevic and Wang. Mrvaljevic in view of Wang does not teach an ECG and a BCG/PPG for PTT. Wong, in the same field of endeavor, teaches a wearable garment with ECG, BCG and PPG sensors configured to worn by an individual (Abstract), similar to the device of Mrvaljevic, and further teaches wherein biosensor is a ballistocardiogram (BCG) sensor (Abstract “The sleeves of the tee-shirt having an electrocardiogram (ECG) sensor, a photoplethysmogram (PPG) sensor or a ballistocardiogram (BCG) sensor for monitoring the pulse of a person wearing the tee-shirt.” [0074] “In another embodiment of the invention, a ballistocardiogram (BCG) sensor is placed on the clothing in place of the ECG. Alternatively the BCG sensor is placed in addition to the ECG.”) to monitor health events at different parts of the body ([0059]). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention to modify the invention of Mrvaljevic, with the ECG and a BCG/PPG for PTT of Wong, because such a modification would allow to monitor health events at different parts of the body.
Regarding claim 32, claim 21 is obvious over Mrvaljevic and Wang. Mrvaljevic in view of Wang does not teach an ECG and a BCG/PPG for PTT. Wong, in the same field of endeavor, teaches a wearable garment with ECG, BCG and PPG sensors configured to worn by an individual (Abstract), similar to the device of Mrvaljevic, and further teaches wherein the biosensor is a photoplethysmogram (PPG) sensor ([0045] “The tee-shirt 100 has two short sleeves 101.” [0055] “FIG. 2 shows another embodiment 200 of the invention wherein, instead of the ECG, the device placed in the band in the sleeve 101 of the tee-shirt is a photoplethysmogram (PPG) sensor 203.”) to monitor health events at different parts of the body ([0059]). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention to modify the invention of Mrvaljevic in view of Kruger, with the ECG and a BCG/PPG for PTT of Wong, because such a modification would allow to monitor health events at different parts of the body.
Claim(s) 39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mrvaljevic et al. (US 20190290181) (Hereinafter Mrvaljevic) in view of Wang et al. (US 20180146922) (Hereinafter Wang) and Jayaraman et al. (US 9582038) (Hereinafter Jayaraman).
Regarding claim 39, claim 21 is obvious over Mrvaljevic and Wang. Mrvaljevic in view of Wang does not teach an enclosure for mechanically interconnects the controller to the garment. Jayaraman, in the same field of endeavor, teaches a smart garment containing a controller and electrical leads to connect to the rest of the garment (Abstract), similar to the device of Mrvaljevic, and further teaches wherein the enclosure for receiving the controller device projects from the garment, the enclosure configured to electrically interconnect the controller device, the primary sensor panel, and the complementary sensor panel using the one or more conductive fibres (Col. 5 lines 16-22 “The top housing (202) [enclosure that is projected out of the garment] of the smart hub (102) of FIG. 2 is configured for physical engagement with a controller (104). That is, the top housing (202) of the smart hub of FIG. 2 is shaped such that the controller is secured [mechanically] within the smart hub with sufficient stability from physical interaction to make electrical contact with one or more electrical leads of the smart hub as discussed in more detail below.” Col. 3 lines 1-4 “Wired networks may be implemented as one or more conductive paths from at least one the sensors of the smart garment to the smart hub implemented through conductive fibers woven or knitted into the smart garment”) to repeatedly wash or clean the garment without damaging the controller (Col. 7 lines 1-2). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention to modify the invention of Mrvaljevic, with the enclosure for mechanically interconnects the controller to the garment of Jayaraman, because such a modification would allow to repeatedly wash or clean the garment without damaging the controller.
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mrvaljevic et al. (US 20190290181) (Hereinafter Mrvaljevic) in view of Wang et al. (US 20180146922) (Hereinafter Wang) and Proenca et al. (US 20210038095) (Hereinafter Proenca).
Regarding claim 23, claim 21 is obvious over Mrvaljevic and Wang. Mrvaljevic in view of Wang and do not teach the determination of blood pressure based on the determined PTT. Proenca, in the same field of endeavor, teaches a wearable support to be worn by a user that includes a PPG sensor and electrodes for measuring ECG (Abstract and [0009]), similar to the device of Mrvaljevic, and further teaches wherein the controller device is configured to determine blood pressure for the user based on one or more of determined PAT, PEP, VEMD, and/or PTT ([0018] “determining a pulse transit time (PTT) value from the determined PEP value and the determined PAT value; and determining a blood pressure (BP) value from the determined PTT value.”) to more advantageously determine blood pressure from 2 locations ([0019]). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention to modify the invention of Mrvaljevic, with the determination of blood pressure based on the determined PTT of Proenca, because such a modification would allow to more advantageously determine blood pressure from 2 locations.
Claim(s) 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mrvaljevic et al. (US 20190290181) (Hereinafter Mrvaljevic) in view of and Wang et al. (US 20180146922) (Hereinafter Wang) and Bogdanovich et al. (US 20190046114) (Hereinafter Bogdanovich).
Regarding claim 29, claim 21 is obvious over Mrvaljevic and Wang. Mrvaljevic in view of Wang does not teach a controller for determining a user is asleep as a function of heart rate of a user. Bogdanovich, in the same field of endeavor, teaches a garment containing sensors for determining respiration, heart properties, and motion sensing (Abstract), similar to the device of Mrvaljevic, and further teaches wherein the controller device is configured to determine that the user is asleep as a function of user heart rate ([0096] “Their heart rates dip more at night during sleep than their lower-performing counterparts, and they hit harder with a more robust “engage threat” response when called upon.”) to determine the state of a user ([0095]). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention to modify the invention of Mrvaljevic in view of Wang, with the determining a user is asleep as a function of heart rate of a user of Bogdanovich, because such a modification would allow to determine the state of a user. The motivation to combine may be implicit and may be found in the knowledge of one of ordinary skill in the art, or, in some cases, from the nature of the problem to be solved. Id. at 1366, 80 USPQ2d at 1649. See MPEP 2143(I)(G).
Claim(s) 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mrvaljevic et al. (US 20190290181) (Hereinafter Mrvaljevic) in view of Wang et al. (US 20180146922) (Hereinafter Wang) and Etemadi et al. (“Wearable ballistocardiogram and seismocardiogram systems for health and performance” J Appl Physiol (1985). 2018 Feb 1; 124(2): 452–461. Published online 2017 Aug 10) (Hereinafter Etemadi).
Regarding claim 33, claim 21 is obvious over Mrvaljevic and Wang. Mrvaljevic in view of Wang teaches the ECG and BCG sensors placed together ([0074] but does not teach the estimation of a hemodynamic metrics based on the combination of ECG and BCG. Etemadi, in a similar field of endeavor, teaches a wearable patch that measure BCG, PPG, and ECG data (Pg. 2 lines 16-17 and line 26). Although the device is not a wearable garment, both Mrvaljevic and Etemadi are skin worn devices that require obtaining physiological data from a user. Etemadi further teaches wherein the controller device is configured to estimate hemodynamic metrics based on a combination of ECG sensor data and BCG sensor data (Pg. 7 lines 11-12 “We found that a BCG-derived time interval—the delay from the R wave [metric] of the ECG to the J wave [metric] of the BCG—was strongly correlated to PEP with near-unity slope [metric]” Examiner notes that R and J waves are metrics used to determine PEP.) to correlate changes in contractility (Pg. 7 line 6). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention to modify the invention of Mrvaljevic, with the estimation of a hemodynamic metrics based on the combination of ECG and BCG of Etemadi, because such a modification would allow to correlate changes in contractility.
Claim(s) 35 and 37-38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mrvaljevic et al. (US 20190290181) (Hereinafter Mrvaljevic) in view of Wang et al. (US 20180146922) (Hereinafter Wang), Jayaraman et al. (US 9582038) (Hereinafter Jayaraman), and Chahine et al. (US 20170079348) (Hereinafter Chahine).
Regarding claim 35, claim 21 is obvious over Mrvaljevic and Wang. Mrvaljevic in view of Wang does not teach conductive fibres knitted along with a base fabric of the garment. Chahine, in a similar field of endeavor, teaches electrically conductive threads on fabrics that can be applied to monitor body signal (Abstract and [0001]-[0003]), and further teaches wherein the one or more conductive fibres are knit along with a base fabric in a layer of the garment ([0040] “In this example, three-dimensional conductive knit patch 2 consists of a base fabric (e.g. surface) 10 as a first portion integrally formed (e.g. knit) with a conductive fabric (e.g. group of conductive fibres) 8 as a second portion of a single layer 11 (see also FIG. 10).”) to integrate the functional textile article ([0043]). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention to modify the invention of Mrvaljevic, with the conductive fibres knitted along with a base fabric of the garment of Chahine, because such a modification would allow to integrate the functional textile article.
Regarding claim 37, claim 21 is obvious over Mrvaljevic and Wang. Mrvaljevic in view of Wang does not teach conductive fibres forming a length of interlocked fibres. Chahine, in a similar field of endeavor, teaches electrically conductive threads on fabrics that can be applied to monitor body signal (Abstract and [0001]-[0003]), and further teaches wherein the one or more conductive fibres form a length of interlocked fibers ([0044] “Generally, textiles are formed using yarn, where yarn refers to a long continuous length of a plurality of fibres that have been interlocked (i.e. fitting into each other, as if twined together, or twisted together). Herein, the terms fibre and yarn are used interchangeably… Conductive fabric (e.g. group of conductive fibres) 8 can also be formed as per the weaving structures as provided in FIG. 12.”) to integrate the functional textile article ([0043]). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention to modify the invention of Mrvaljevic, with the conductive fibres forming a length of interlocked fibres of Chahine, because such a modification would allow to integrate the functional textile article.
Regarding claim 38, claim 21 is obvious over Mrvaljevic and Wang. Mrvaljevic in view of Wang does not teach conductive fibres knitted into the garment. Chahine, in a similar field of endeavor, teaches electrically conductive threads on fabrics that can be applied to monitor body signal (Abstract and [0001]-[0003]), and further teaches wherein the one or more conductive fibres is/are knitted into the garment ([0042] “the conductive fabric (e.g. group of conductive fibres) 8 as a first portion can be knit along with (e.g. to be integral with) the base fabric (e.g. surface) 10 in a layer 11, such as on but not limited to a SANTONI® circular knit machine. The base fabric surface 10 of the conductive knit patch 2 can be a part of a larger garment 1 such that the garment 1 incorporates the conductive knit patch 2.) to integrate the functional textile article ([0043]). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention to modify the invention of Mrvaljevic, with the conductive fibres knitted into the garment of Chahine, because such a modification would allow to integrate the functional textile article.
Claim(s) 36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mrvaljevic et al. (US 20190290181) (Hereinafter Mrvaljevic) in view of Wang et al. (US 20180146922) (Hereinafter Wang) and Markel (US 20120136231) (Hereinafter Markel).
Regarding claim 36, claim 21 is obvious over Mrvaljevic and Wang. Mrvaljevic in view of Wang does not teach conductive fibres knitted into a seam of the garment. Markel, in a similar field of endeavor, teaches a garment with health monitoring capability including ECG sensors (Abstract and [0027]), and further teaches wherein the one or more conductive fibres are knitting into a seam of the garment ([0035] “For such sensors, leads (e.g., wire leads, conductive fiber leads, etc.) may be woven into the garment, run via garment seams”) to integrate the leads into the garment ([0035]). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention to modify the invention of Mrvaljevic, with the conductive fibres knitted into a seam of the garment of Markel, because such a modification would allow to integrate the leads into the garment.
Conclusion
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/MOUSSA HADDAD/Examiner, Art Unit 3796
/REX R HOLMES/Primary Examiner, Art Unit 3796