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 .
Response to Amendment
This Office Action is responsive to the amendment filed on 05/15/2026. As directed by the amendment: Claims 1, 8, and 11 have been amended, claims 2, 4-5, and 18-19 have been cancelled, and no claims have been added. Thus, claims 1, 3, 6-17, and 20-22 are presently under consideration in this application.
Response to Arguments
Applicant’s arguments, see pages 2-4, filed 05/15/2026, with respect to the rejection(s) of the claim(s) under claim objections have been fully considered and are persuasive. Amendments obviate the rejection of record. Therefore, the objection of the claims has been withdrawn.
Applicant’s arguments, see pages 2-4, filed 05/15/2026, with respect to the rejection(s) of the claim(s) under 35 U.S.C. 112 have been fully considered. Applicant argues on pages 2-3 that the amendments of the pocket-like textile enclosure that define a cavity is supported in the instant specification and the cited portions of page 2 “provide support for the amended pocket-like enclosure, cavity, removable controller, docking device, conductive-fibre coupling, and electrical interconnection features.” Examiner agrees that the pocket-like enclosure, cavity, removable controller, conductive-fibre coupling, and electrical interconnection features have sufficient support, however, the textile docking device remains unknown as to what the device encompasses.
Applicant then argues on page 3 that “The Examiner also objected that the claims did not sufficiently describe how a single bio- signal waveform is used to determine PTT. Claims 1 and 11 have been amended to remove the "single bio-signal waveform" formulation and instead recite generation of "one or more bio-signal waveforms" and determination of PTT values based on relative timing between a proximal waveform and a distal waveform indicative of an arterial pulse. This amendment tracks the disclosed PTT approach. Paragraph [0090] explains that PTT "may be the time delay for a pressure wave to travel between two arterial positions" and "may be estimated based on relative timing between proximal and distal waveforms indicative of an arterial pulse." Paragraph [0091] describes PPG bio-signal waveforms indicative of proximal and distal blood volumes. Paragraph [0093] further explains that "the time delay between the ECG waveform and a distal arterial waveform may be called the pulse arrival time (PAT)" and that "an ECG waveform may be used as a surrogate proximal waveform." Thus, the amended claims clarify that PTT is determined from timing relationships between proximal and distal waveforms, rather than from an unexplained single waveform.”
Examiner disagrees because the instant specification fails to provide details as to what within the biosignal waveforms are looked at to determine PTT. Furthermore, the specification requires ECG and PPG sensors used to correlate PTT data and blood pressure ([0094]), but does not disclose proximal and distal waveforms as ECG and PPG signals, respectively.
Lastly, Applicant argues on page 3 that “The Examiner further objected to the "without temporal tightening" language. Claims and 11 have been amended to recite "without any temporal tightening during data acquisition," consistent with the specification. Paragraph [0070] states that the garment may be configured to position or press the sensor panels against the user limb "without any temporal tightening during data acquisition," and explains that the garment avoids tightening akin to "a sphygmomanometer inflating to collapse a user's artery during blood pressure measurements."”
Examiner agrees. Nevertheless, the rejections are maintained for the reasons of record.
Applicant’s arguments, see pages 4-6, filed 05/15/2026, with respect to the rejection(s) of the claim(s) under 35 U.S.C. 103 have been fully considered and are persuasive. The amendments obviate the rejection of record. Therefore, the rejection has been withdrawn. See updated rejection below.
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 docking device” in lines 21-22 of claim 1. The instant specification fails to provide structure as to what the “textile docking device” may be, but describes “textile docking device” to receive the textile enclosure, which is different than what is claimed as containing “conductive contact regions integrated with the textile enclosure” for mechanical retention. Examiner interprets the “textile docking device” as conductive leads in a cavity for retaining the controller.
“control device” in lines 10 of claim 11. The instant specification and claim 1 provides structure as the processor. Examiner suggests amending to clarify that the control device comprises a processor.
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 1, 3, 6-17, and 19-22 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).
Claims 1 and 11 fail to sufficiently describe the proximal and distal waveform for determining PTT to show possession of the claimed invention. The mere statement and recitation of “determine pulse transit time (PTT) values based on relative timing between a proximal waveform and a distal waveform indicative of an arterial pulse, determine blood pressure of a user based on correlations with the PTT values” in claims 1 and 11 and [0090]-[0095] of the instant specification discloses PTT is received from multiple biosensors. However, the instant specification provides insufficient detail as to how this calculation from the biosensor signals to PTT is performed, let alone performed by a proximal and distal waveform not from the garment obtained from the primary and secondary sets of sensors. It is further unknown how the proximal and distal waveforms are related to the user as there is no mention as to 1) what signals they represent from which specific biosensor, 2) how these signals are obtained from the user, and 3) how PTT is obtained from “proximal” and “distal” waveforms. The instant specification fails to provide details as to what within the biosignal waveforms are looked at to determine PTT, and which specific physiological sensors and signals are used to determine the PTT. It is further unknown how PTT values can be used to correlate blood pressure. Other than the nominal recitation of being done, the instant specification fails to disclose how to analyze the PTT data to determine blood pressure. Therefore, claims 1, 3, 6-17, and 19-22 do not provide sufficient detail for having sufficient written description.
Claims 1 and 11 fail to sufficiently describe the structure for “textile docking device”, to show possession of the claimed invention. The mere statement and recitation of “textile docking device” in claims 1 and 11 and Page 22 of the instant specification disclosing that the textile docking device received within the textile enclosure and coupled to the conductive fibre to electrically connect the controller, the textile enclosure being a cavity that projects from the sleeve, and the there being a textile material (page 8 of the instant specification) fails to provide structure for any of these terms, other than their mere description of their respective function. Regarding the textile docking device, it is unknown what the structure that is associated with such a phrase. Therefore, claims 1, 3, 6-17, and 19-22 do not provide sufficient detail for having sufficient written description of the structural components of “textile docking device”.
Claims 1, 3, 6-17, and 19-22 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.
The analysis of whether the specification complies with the written description requirement calls for the examiner to compare the scope of the claim with the scope of the description to determine whether applicant has demonstrated that the inventor was in possession of the claimed invention. Such a review is conducted from the standpoint of one of ordinary skill in the art at the time the application was filed (see, e.g., Wang Labs., Inc. v. Toshiba Corp., 993 F.2d 858, 865, 26 USPQ2d 1767, 1774 (Fed. Cir. 1993)) and should include a determination of the field of the invention and the level of skill and knowledge in the art. For some arts, there is an inverse correlation between the level of skill and knowledge in the art and the specificity of disclosure necessary to satisfy the written description requirement. Information which is well known in the art need not be described in detail in the specification. See, e.g., Hybritech, Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1379-80, 231 USPQ 81, 90 (Fed. Cir. 1986). However, sufficient information must be provided to show that the inventor had possession of the invention as claimed. See MPEP 2163 (II)(2).
A "representative number of species" means that the species which are adequately described are representative of the entire genus. See MPEP 2163(III)(a)(ii).
The Federal Circuit has explained that a specification cannot always support expansive claim language and satisfy the requirements of 35 U.S.C. 112 "merely by clearly describing one embodiment of the thing claimed." LizardTech v. Earth Resource Mapping, Inc., 424 F.3d 1336, 1346, 76 USPQ2d 1731, 1733 (Fed. Cir. 2005). The issue is whether a person skilled in the art would understand inventor to have invented, and been in possession of, the invention as broadly claimed. In LizardTech, claims to a generic method of making a seamless discrete wavelet transformation (DWT) were held invalid under 35 U.S.C. 112, first paragraph, because the specification taught only one particular method for making a seamless DWT and there was no evidence that the specification contemplated a more generic method. Id.; see also Tronzo v. Biomet, 156 F.3d at 1159, 47 USPQ2d at 1833 (Fed. Cir. 1998)(holding that the disclosure of a species in a parent application did not provide adequate written description support for claims to a genus in a child application where the specification taught against other species). See MPEP 2163(III)(a)(ii).
Claims 1 and 11 fails to sufficiently describe the identifying of a potential adverse health event in enough detail for one skilled in the art to have possession of the broadly claimed genus. Although the term adverse health event is used in the instant specification ([0105]), and specifically defines different health events that can be identified in [0068] “fainting, confusion, heart attacks/strokes, dehydration, allergic reactions, shocks, hypothermic conditions, heat strokes, or other physical traumatic events.”. However, the observing a blood pressure drop below a threshold may not be associate with all types of adverse health events such as heart disease, arrhythmias, or migraines. Similar to Lizardtech, there is no evidence that the specification contemplated a more generic method of identifying any and all types of adverse health events. Therefore, claims 1, 3-12, and 14-22 do not provide sufficient detail for a person skilled in the art to have been in possession of the invention as broadly claimed.
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, 3, 6-17, and 19-22 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 claim 1, it is unclear is the “bio signals” of line 42 is the same or different than the “one or more bio-signal waveforms” of line 35 and the set of biosignals from the primary and secondary sensor panels.
Claim 1 recites the limitation "the garment user" in line 46. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 1, it is unclear is the “bio signals” of line 16 is the same or different than the “one or more bio-signal waveforms” of line 10 and the set of biosignals from the primary and secondary sensor panels.
Claim 8 fails to clearly claim the subject matter as they depend from a non-existent claim (undefined) and is unclear what are the metes and bounds of the claim. Due to these deficiencies, claims 8 are unable to be examined since the claims were not able to be searched for an art rejection.
Regarding claim 8, the claim is an incomplete sentence as the claim is missing an uppercase letter at the start.
Claim 11 recites the limitation "the garment user" in line 20. There is insufficient antecedent basis for this limitation in the claim.
The term “substantially consistent pressure” in claim 11 is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear the degree to which the pressure has to be consistent.
Claim limitation “textile docking device presenting conductive contact regions” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. It is unclear what the textile docking device may be and how the docking device is electrically connected to the controller. 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) 1, 7-8, 10-12, 14-17, and 21-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. (US 20180092554) (Hereinafter Zhang) in view Mrvaljevic et al. (US 20190290181) (Hereinafter Mrvaljevic) (see WO/2018/013580 for the priority date of 12/27/2018), Markel (US 20120136231) (Hereinafter Markel), Jayaraman et al. (US 9582038) (Hereinafter Jayaraman), and Muhlsteff et al. (US 20090204013)(Hereinafter Muhlsteff).
Regarding claims 1 and 11, Zhang teaches A garment for detecting blood pressure (Abstract “Novel and advantageous systems, devices, and methods for pulse wave velocity (PWV) imaging that enable precise central blood pressure (BP) estimation are provided.” Fig. 1 shirt) comprising:
a garment body ([0006] “FIG. 1 shows a schematic view of a multi-sensor array shirt”);
a primary sensor panel affixed to a user facing side of the garment body, the primary sensor panel including at least two bio signal sensor types selected from a photoplethysmogram (PPG) sensor, an electrocardiogram (ECG) sensor, and a ballistocardiogram (BCG) sensor (Fig. 1 (2 primary sensor panel) [0020] “including at least one electrode 17 and at least one PPG sensor 18 collecting ECG and PPG signals” See Fig. 3. [0017] “During a measurement, the shirt positioned up close to the body to contact the user's skin [user facing side] can measure the PPG and ECG waveforms.”);
the primary sensor panel is configured to contact a user’s limb without any temporal tightening during data acquisition and with substantially constant pressure (Zhang does not teach the tightening of the primary sensor panel during biosignal generation and therefore meets this limitation. The garment being worn on a user allows for substantially constant pressure.);
a complementary sensor panel distal from the primary sensor panel and affixed to the user-facing side of the garment body, the complementary sensor panel configured to generate a secondary set of bio signals (Fig. 1 (2 primary sensor panel amongst the many on the shirt) [0020] “including at least one electrode 17 and at least one PPG sensor 18 collecting ECG and PPG signals” See Fig. 3. [0017] “During a measurement, the shirt positioned up close to the body to contact the user's skin [user facing side] can measure the PPG and ECG waveforms.”);
a processor coupled to the primary sensor panel ([0005] “and at least one processor in operable communication with the front-end circuit to calculate pulse transmit time (PTT) from the ECG and PPG signals”); and
wherein, when executed, the processor-executable instructions ([0027] “machine-readable media (e.g., computer-readable media)”), configure the processor to:
receive, from the primary sensor panel, a primary set of bio signals comprising bio-signals from the at least two bio-signal sensor types ([0020] “including at least one electrode 17 and at least one PPG sensor 18 collecting ECG and PPG signals”);
receive, from the complementary sensor panel, a secondary set of bio-signals ([0005] “each sensor unit including at least one electrical sensor for detecting ECG signals of a user and at least one optical sensor for detecting PPG signals of said user”);
generate one or more bio-signal waveforms based on the primary and secondary set of bio-signals ([0005] “each sensor unit including at least one electrical sensor for detecting ECG signals of a user and at least one optical sensor for detecting PPG signals of said user” Examiner notes that the ECG and PPG signals from all of the sensor panels produce a waveform.);
determine pulse transit time (PTT) values based on relative timing between a proximal waveform and a distal waveform indicative of an arterial pulse ([0005] “and at least one processor in operable communication with the front-end circuit to calculate pulse transmit time (PTT) from the ECG [proximal waveform] and PPG signals [distal waveform]”); and
determine a hemodynamic metric representing blood pressure of the user based on correlations with the PTT values ([0018] “PTT has a reciprocal relationship with PWV, and can be easily obtained from two pulse signals, such as ECG and PPG signals.” See claim 1 and 6 recites that PTT is calculated to generate PWV imaging which is used in a second algorithm for estimating blood pressure.).
However, Zhang does not teach the one or more conductive fibres interconnect the primary sensor panel, the complementary sensor panel, and a controller device and the textile enclosure comprising knitted textile material and being configured to removably receive the controller device, the textile enclosure comprising a textile docking device received within the cavity and coupled to the one or more conductive fibres…to electrically interconnect the controller device to the one or more conductive fibres. Mrvaljelic, in the same field of endeavor, teaches the use of ECG, accelerometer and EMG sensors on clothing with a controller ([0032]), similar to the device of Zhang, and further teaches upon insertion of the controller device ([0030] “the controller 125 can include a CPU 431”); and
the one or more conductive fibres interconnect the primary sensor panel, the complementary sensor panel, and a 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.”);
the textile enclosure comprising knitted textile material and being configured to removably receive the controller device, the textile enclosure comprising a textile docking device received within the cavity and coupled to the one or more conductive fibres…to electrically interconnect the controller device to the one or more conductive fibres ([0031] “the controller 125 can be inserted into a pocket 443 [textile enclosure, which is also knitted textile material as the pocket is part of the garment] 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.) to easy removeable off the clothing for charging ([0031]). 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 Zhang, with one or more conductive fibres interconnect the primary sensor panel, the complementary sensor panel, and a controller device and the textile enclosure comprising knitted textile material and being configured to removably receive the controller device, the textile enclosure comprising a textile docking device received within the cavity and coupled to the one or more conductive fibres…to electrically interconnect the controller device to the one or more conductive fibres of Mrvaljelic, because such a modification would allow to easy removeable off the clothing for charging.
Zhang in view of Mrvaljevic not teach one or more conductive fibres knitted in the garment body and configured to conduct at least one of a data signal or a power signal, the one or more conductive fibres interconnect the primary sensor panel, the complementary sensor panel. Markel, in a similar field of endeavor, teaches a garment with health monitoring capability including ECG sensors (Abstract and [0027]), and further teaches one or more conductive fibres knitted in the garment body and configured to conduct at least one of a data signal or a power signal, the one or more conductive fibres interconnect the primary sensor panel, the complementary sensor panel ([0035] “For such sensors, leads (e.g., wire leads, conductive fiber leads, etc.) may be woven into the garment, run via garment seams… ECG analysis includes analyzing differences in electrical potential [data signal] between various skin contact points (or electrodes)” It is noted that [0067]-[0069] are different sensors that are interconnected to the central region, similar to that of the primary and complementary sensor panels.) 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 Zhang in view of Mrvaljevic, with one or more conductive fibres knitted in the garment body and configured to conduct at least one of a data signal or a power signal, the one or more conductive fibres interconnect the primary sensor panel, the complementary sensor panel of Markel, because such a modification would allow to integrate the leads into the garment.
Zhang in view of Mrvaljevic and Markel do not teach textile enclosure defining a cavity and projecting from the garment body, … being configured to removably receive the controller device, the textile enclosure comprising a textile docking device received within the cavity and coupled to the one or more conductive fibres and textile docking device presenting conductive contact regions integrated with the textile enclosure and configured to mechanically retain the controller device in the cavity and to electrically interconnect the controller device to the one or more conductive fibres. 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 Wong, and further teaches a pocket-like textile enclosure defining a cavity and projecting from the garment body, the pocket-like textile enclosure being configured to removably receive the controller device, the pocket-like textile enclosure comprising a textile docking device received within the cavity and coupled to at least one of the one or more conductive fibres (Col. 5 lines 16-22 “The top housing (202) [enclosure docking device that is projected out of the garment, that contains a cavity for inserting the controller] 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 within the smart hub with sufficient stability from physical interaction to make electrical contact [electrically interconnect] 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 electrically interconnect the received controller device and the garment body upon insertion of the controller device (Fig. 6 (electrical leads 216 [conductive contact regions] with lead paths 212) Col. 7 lines 22-27 “The aperture of FIG. 2 also exposes to the controller a magnetic engagement corresponding with a magnetic engagement of the controller. When the controller of FIG. 2 is engaged with the top housing of the smart hub, the contacts of the controller may mate with the electrical leads of the smart hub and a magnetic engagement provides additional stability and engagement between the smart hub and the controller.” 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 Zhang in view of Mrvaljevic and Markel, with the textile enclosure defining a cavity and projecting from the garment body, … being configured to removably receive the controller device, the textile enclosure comprising a textile docking device received within the cavity and coupled to the one or more conductive fibres and textile docking device presenting conductive contact regions integrated with the textile enclosure and configured to mechanically retain the controller device in the cavity and to electrically interconnect the controller device to the one or more conductive fibres of Jayaraman, because such a modification would allow to repeatedly wash or clean the garment without damaging the controller.
However, Zhang in view of Mrvaljevic, Markel, and Jayaraman do not teach periodically receive bio signals over time, identify a potentially adverse health event when the determined blood pressure drops by more than a threshold amount within a determined period of time, and in response transmit alert signals to the user's mobile device or to computing systems or activate one or more actuators embedded in the garment for providing feedback to the garment user. Muhlsteff, in the same field of endeavor, teaches a wearable garment for measuring vital signs to obtain blood pressure using electrodes to obtain PTT (Abstract), and further teaches periodically receive bio signals over time, identify a potentially adverse health event when the determined blood pressure drops by more than a threshold amount within a determined period of time, and in response transmit alert signals to the user's mobile device or to computing systems or activate one or more actuators embedded in the garment for providing feedback to the garment user ([0055] “Relative blood pressure changes [blood pressure drops by more than a threshold]” [0062] “Continuous Blood Pressure monitoring” Claim 10 “further comprising an alarm for alerting the patient to a critical condition.” Claim 11 “further comprising means for sending an alert to a source of external professional assistance.”) to continuously monitor blood pressure without having to be confined to be at a hospital or the presence of a doctor ([0002]). 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 Zhang in view of Mrvaljevic, Markel, and Jayaraman, with periodically receive bio signals over time, identify a potentially adverse health event when the determined blood pressure drops by more than a threshold amount within a determined period of time, and in response transmit alert signals to the user's mobile device or to computing systems or activate one or more actuators embedded in the garment for providing feedback to the garment user of Muhlsteff, because such a modification would allow to continuously monitor blood pressure without having to be confined to be at a hospital or the presence of a doctor.
Regarding claims 7, Zhang teaches comprising wherein the complementary sensor panel is distal from the primary sensor panel and affixed to the user limb facing side of the garment body ([0030] “a plurality of sensor units, each sensor unit including at least one electrical sensor for detecting electrocardiogram (ECG) signals of a user and at least one optical sensor for detecting photoplethysmogram (PPG) signals of said user” Since each sensor unit contains its own ECG and PPG sensor for producing their own PPG and ECG signal, and there are a plurality of sensor units, a second sensor unit is taught and can produce its own ECG and PPG signals. See Fig. 1 where sensor units can be place on the sleeve where the arm of the user is.).
Regarding claims 8, Zhang 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 conductive fibre interconnects the primary sensor panel and the complementary sensor panel ([0035] “For such sensors, leads (e.g., wire leads, conductive fiber leads, etc.) may be woven into the garment, run via garment seams… ECG analysis includes analyzing differences in electrical potential [data signal] between various skin contact points (or electrodes)” It is noted that [0067]-[0069] are different sensors that are interconnected to the central region, similar to that of the primary and complementary sensor panels.) 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 Zhang in view of Mrvaljevic, Markel, Muhlsteff, and Jayaraman, 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.
Regarding claims 10, Zhang teaches wherein the garment is a shirt configured to be worn on an upper body of the user, and wherein the primary sensor panel is positioned on a shirt sleeve (See Fig. 1 where sensor units can be place on the sleeve where the arm of the user is.).
Regarding claims 21, Mrvaljevic teaches wherein the textile enclosure is moisture-resistant ([0030] “the controller 125 can be packaged in a water-resistant, resilient housing 442 having a small form factor.”).
Regarding claim 12, Zhang teaches wherein the primary sensor panel is configured to | determine pulse transit time (PTT) data for determining a blood pressure metric associated with the user ([0018] “PTT has a reciprocal relationship with PWV, and can be easily obtained from two pulse signals, such as ECG and PPG signals.” See claim 1 and 6 recites that PTT is calculated to generate PWV imaging which is used in a second algorithm for estimating blood pressure.).
Regarding claims 14, Zhang teaches wherein the garment is a shirt configured to be worn on an upper body of the user, and wherein the primary sensor panel is positioned on a shirt sleeve (See Fig. 1 where sensor units can be place on the sleeve where the arm of the user is.).
Regarding claims 15, Zhang teaches comprising wherein the complementary sensor panel is distal from the primary sensor panel and affixed to the user limb facing side of the garment body ([0030] “a plurality of sensor units, each sensor unit including at least one electrical sensor for detecting electrocardiogram (ECG) signals of a user and at least one optical sensor for detecting photoplethysmogram (PPG) signals of said user” Since each sensor unit contains its own ECG and PPG sensor for producing their own PPG and ECG signal, and there are a plurality of sensor units, a second sensor unit is taught and can produce its own ECG and PPG signals. See Fig. 1 where sensor units can be place on the sleeve where the arm of the user is.).
Regarding claims 16, Zhang 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 comprising a conductive fibre knitted in the garment body and configured to conduct at least one of a data signal or a power signal, wherein the conductive fibre interconnects the primary sensor panel and the complementary sensor panel ([0035] “For such sensors, leads (e.g., wire leads, conductive fiber leads, etc.) may be woven into the garment, run via garment seams… ECG analysis includes analyzing differences in electrical potential [data signal] between various skin contact points (or electrodes)” It is noted that [0067]-[0069] are different sensors that are interconnected to the central region, similar to that of the primary and complementary sensor panels.) 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 Zhang in view of Mrvaljevic, Markel, Muhlsteff, and Jayaraman, 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.
Regarding claim 17, Zhang 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 Zhang in view of Mrvaljevic, Markel, Muhlsteff, and Jayaraman, 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.
Regarding claims 22, Mrvaljevic teaches wherein the textile enclosure is moisture-resistant ([0030] “the controller 125 can be packaged in a water-resistant, resilient housing 442 having a small form factor.”).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. (US 20180092554) (Hereinafter Zhang) in view Mrvaljevic et al. (US 20190290181) (Hereinafter Mrvaljevic) (see WO/2018/013580 for the priority date of 12/27/2018), Markel (US 20120136231) (Hereinafter Markel), Jayaraman et al. (US 9582038) (Hereinafter Jayaraman), Muhlsteff et al. (US 20090204013)(Hereinafter Muhlsteff), and Pantelopoulos et al. (US 20170209053) (IDS) (Hereinafter Pantelopoulos).
Regarding claims 3, claim 1 is obvious over Zhang, Mrvaljevic, Markel, Muhlsteff, and Jayaraman. Zhang in view of Mrvaljevic, Markel, Muhlsteff, and Jayaraman do not teach an responsively acquiring signals based on movement detected by an accelerometer. Pantelopoulos, in the same field of endeavor, teaches the measuring blood pressure based on PTT measure from PPG and ECG sensors ([0008] and [0023]), similar to the device of Zhang. Although Pantelopolous is not directed to a garment, both Zhang and Pantelopoulos teach the detection on a limb. Pantelopoulos further teaches comprising at least one of an accelerometer or a piezo sensor integrated in the garment body, and wherein in response to receiving a trigger signal generated by at least one of the accelerometer or the piezo sensor indicating movement of the user, generating the primary set of bio siqnals including bio signals from a combination of the at least two sensor types of the primary sensor panel ([0176] “For instance, when data from a motion sensor(s) indicates a period of stillness or of little motion, the biometric monitoring device may trigger, acquire, and/or obtain a pulse waveform or heart rate measurement or data. (See, for example, FIGS. 16, 19A, and 19B).” [0181] “accelerometer”) to acquire more desirable quality signal ([0179]). 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 Zhang in view of Mrvaljevic, Markel, Muhlsteff, and Jayaraman, with responsively acquiring signals based on movement detected by an accelerometer of Pantelopoulos, because such a modification would allow to acquire more desirable quality signal.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. (US 20180092554) (Hereinafter Zhang) in view Mrvaljevic et al. (US 20190290181) (Hereinafter Mrvaljevic) (see WO/2018/013580 for the priority date of 12/27/2018), Markel (US 20120136231) (Hereinafter Markel), and Jayaraman et al. (US 9582038) (Hereinafter Jayaraman), Muhlsteff et al. (US 20090204013)(Hereinafter Muhlsteff), and Varadan et al. (US 20170354372) (Hereinafter Varadan).
Regarding claims 6, claim 1 is obvious over Zhang, Mrvaljevic, Markel, Muhlsteff, and Jayaraman. Zhang in view of Mrvaljevic, Markel, Muhlsteff, and Jayaraman do not teach bio impedance sensors for determining blood pressure. Varadan, in the same field of endeavor, teaches sensors mounted on a textile, specifically on a garment (Abstract and [0029]), similar to the device of Zhang, and further teaches wherein the primary sensor panel includes a pair of electrical bio impedance sensors measuring electrical blood conductivity for determining the hemodynamic metric ([0111] uses impedance (IPG of [0113] with LEDs and PDs.) for determining PTT which correlated blood pressure.) to accomplish real-time blood pressure measurements without a cuff ([0111]). 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 Zhang in view of Mrvaljevic, Markel, Muhlsteff, and Jayaraman, with bio impedance sensors for determining blood pressure of Varadan, because such a modification would allow to accomplish real-time blood pressure measurements without a cuff.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. (US 20180092554) (Hereinafter Zhang) in view Mrvaljevic et al. (US 20190290181) (Hereinafter Mrvaljevic) (see WO/2018/013580 for the priority date of 12/27/2018), Markel (US 20120136231) (Hereinafter Markel), Jayaraman et al. (US 9582038) (Hereinafter Jayaraman), Muhlsteff et al. (US 20090204013)(Hereinafter Muhlsteff), and Park (US 20170251981) (Hereinafter Park).
Regarding claim 9, claim 1 is obvious over Zhang, Mrvaljevic, Markel, Muhlsteff, and Jayaraman. Zhang in view of Mrvaljevic, Markel, Muhlsteff, and Jayaraman do not teach differential set of bio signals used for determining a hemodynamic metric. Park, in the same field of endeavor, teaches receiving signals from a garment containing sensors including ECG sensors ([0049], [0058]), similar to the device of Zhang, and further teaches wherein the primary set of bio signals and the secondary set of bio signals are a differential set of bio signals, and wherein determining the hemodynamic metric associated with the user is based on the differential set of bio signals ([0076] “performs signal processing on the biosignals for removing a noise. The biosignals collected through various paths may have various noise sources. The matching apparatus removes the noise using, for example, a low pass filter and a high pass filter.” Examiner notes that instant spec [0081] discloses the differential signals to be noise reduced signals.) to remove the noise out of the signal for a more accurate signal ([0076]). 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 Zhang in view of Mrvaljevic, Markel, Muhlsteff, and Jayaraman, with differential set of bio signals used for determining a hemodynamic metric of Park, because such a modification would allow to remove the noise out of the signal for a more accurate signal.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. (US 20180092554) (Hereinafter Zhang) in view Mrvaljevic et al. (US 20190290181) (Hereinafter Mrvaljevic) (see WO/2018/013580 for the priority date of 12/27/2018), Markel (US 20120136231) (Hereinafter Markel), Jayaraman et al. (US 9582038) (Hereinafter Jayaraman), Muhlsteff et al. (US 20090204013)(Hereinafter Muhlsteff), and Pantelopoulos et al. (US 20170209053) (IDS) (Hereinafter Pantelopoulos).
Regarding claims 20, claim 1 is obvious over Zhang, Mrvaljevic, Markel, Muhlsteff, and Jayaraman. Zhang in view of Mrvaljevic, Markel, Muhlsteff, and Jayaraman do not teach an responsively acquiring signals based on movement detected by an accelerometer. Pantelopoulos, in the same field of endeavor, teaches the measuring blood pressure based on PTT measure from PPG and ECG sensors ([0008] and [0023]), similar to the device of Zhang. Although Pantelopolous is not directed to a garment, both Zhang and Pantelopoulos teach the detection on a limb. Pantelopoulos further teaches comprising at least one of an accelerometer or a piezo sensor integrated in the garment body, and wherein in response to receiving a trigger signal generated by at least one of the accelerometer or the piezo sensor indicating movement of the user, generating the primary set of bio siqnals including bio signals from a combination of the at least two sensor types of the primary sensor panel ([0176] “For instance, when data from a motion sensor(s) indicates a period of stillness or of little motion, the biometric monitoring device may trigger, acquire, and/or obtain a pulse waveform or heart rate measurement or data. (See, for example, FIGS. 16, 19A, and 19B).” [0181] “accelerometer”) to acquire more desirable quality signal ([0179]). 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 Zhang in view of Mrvaljevic, Markel, Muhlsteff, and Jayaraman, with responsively acquiring signals based on movement detected by an accelerometer of Pantelopoulos, because such a modification would allow to acquire more desirable quality signal.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. (US 20180092554) (Hereinafter Zhang) in view Mrvaljevic et al. (US 20190290181) (Hereinafter Mrvaljevic) (see WO/2018/013580 for the priority date of 12/27/2018), and Markel (US 20120136231) (Hereinafter Markel), Jayaraman et al. (US 9582038) (Hereinafter Jayaraman), Muhlsteff et al. (US 20090204013)(Hereinafter Muhlsteff), and Varadan et al. (US 20170354372) (Hereinafter Varadan).
Regarding claims 13, claim 1 is obvious over Zhang, Mrvaljevic, Markel, Muhlsteff, and Jayaraman. Zhang in view of Mrvaljevic, Markel, Muhlsteff, and Jayaraman do not teach bio impedance sensors for determining blood pressure. Varadan, in the same field of endeavor, teaches sensors mounted on a textile, specifically on a garment (Abstract and [0029]), similar to the device of Zhang, and further teaches wherein the primary sensor panel includes a pair of electrical bio impedance sensors measuring electrical blood conductivity for determining the hemodynamic metric ([0111] uses impedance (IPG of [0113] with LEDs and PDs.) for determining PTT which correlated blood pressure.) to accomplish real-time blood pressure measurements without a cuff ([0111]). 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 Zhang in view of Mrvaljevic, Markel, Muhlsteff, and Jayaraman, with bio impedance sensors for determining blood pressure of Varadan, because such a modification would allow to accomplish real-time blood pressure measurements without a cuff.
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 MOUSSA M HADDAD whose telephone number is (571)272-6341. The examiner can normally be reached M-TH 8:00-6:00.
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/MOUSSA HADDAD/Examiner, Art Unit 3796
/ALLEN PORTER/Primary Examiner, Art Unit 3796
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