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 .
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: “listening sensor” in claims 11-12.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-12 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.
1) Regarding Claim 1, “pertaining to” is subjective and unclear, making the metes and bounds of the claims unclear. Particularly so, given the fact that “patient” and “user” may not be the same, as claimed. Is the patient data captured from the user or not? What does “pertaining to” encompass?
2) Regarding Claims 4, 6, 8, 10, and 12:
- it is not clear whether the “at least one electrode” of Claim 4 is the same or different from the “at least one electrode” of Claim 3.
- it is not clear whether the “at least one pulse oxygen sensor” of Claim 6 is the same or different from the “at least one oxygen sensor” of Claim 5.
- it is not clear whether the “at least one temperature sensor” of Claim 8 is the same or different from the “at least one temperature sensor” of Claim 7.
- it is not clear whether the “at least one ultrasound sensor” of Claim 12 is the same or different from the “at least one ultrasound sensor” of Claim 11.
- it is not clear whether the “at least one listening sensor” of Claim 12 is the same or different from the “at least one listening sensor” of Claim 11.
When a claim is amenable to two plausible interpretations, a rejection under 35 U.S.C. § 112, second paragraph, for indefiniteness, is appropriate. Ex parte Miyazaki, 89 USPQ2d 1207 (BPAI 2008), precedential. Also see Ex parte McAward (Appeal 2015-006416), precedential.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-4, 7-8, and 11-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2021222854 by Rush.
Regarding Claim 1, Rush discloses a medical diagnostic garment (e.g. abstract, Fig. 2A: health monitoring garment 200), said garment comprising:
a main body having a front panel, a back panel, and a neck area (e.g. ¶19, Fig. 2A, Fig. 2B: Fig. 2A shows the front side of the wearable health monitor system 200, Fig. 2B shows the back side of the wearable health monitor system 200, and both figures clearly show a turtleneck portion; Note here that the term “panel” consistent with the specification, merely describes a part of the garment, see e.g. instant ¶27 and Fig. 1 and 2, which indicate portions 11a, 11b, and 11c as “panels”)
a plurality of sensors that are provided along an inside facing portion of the front pane (e.g. ¶21, Fig. 2A: multiple ECG electrodes 223 inside the garment are configured to be placed in contact with skin through a gel; ¶19,21,43: the garment also includes other contact sensors, such as stethoscope microphones 224, blood pressure cuffs 221, thermometers and blood testing devices); and
a controller that is communicatively linked to each of the plurality of sensors, wherein each of the plurality of sensors are configured to capture patient data pertaining to a user wearing the main body (e.g. ¶19,23, Fig. 2A: controller hub 215 is in communication with each of the sensors, and the sensors are configured to capture ECG, acoustic, temperature and other patient data).
Regarding Claim 2, Rush teaches the garment of claim 1, wherein the main body comprises: a shirt that is configured to be worn along a torso of the user (e.g. abstract, ¶10, Fig. 2A: the wearable device 200 may be or include a shirt).
Regarding Claim 3, Rush teaches the garment of claim 1, wherein the plurality of sensors includes one electrode (e.g. ¶19, Fig. 2A: ECG electrodes 223).
Regarding Claim 4, Rush teaches the garment of claim 3, wherein the patient data includes information about a heart of the user collected by the at least one electrode (e.g. ¶19,21,28, Fig. 2A: ECG, heart rate).
Regarding Claim 7, Rush teaches the garment of claim 1, wherein the plurality of sensors includes at least one temperature sensor (e.g. ¶43: thermometer built into the wearable system).
Regarding Claim 8, Rush teaches the garment of claim 7, wherein the patient data includes a body temperature of the user that is collected by at least one temperature sensor (¶43: thermometer built into the wearable system to measure user temperature).
Regarding Claim 11, Rush teaches the garment of claim 1, wherein the plurality of sensors includes one listening sensor (¶19: stethoscope microphones 224).
Regarding Claim 12, Rush teaches the garment of claim 11, wherein the patient data includes sound produced by an internal organ of the user that is collected by one listening sensor (¶30: phonocardiogram PCG acquisition).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 5-6, and 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Rush, as applied to Claim 1, in view of US 20200029899 by Bogdanovich.
Regarding Claim 5, Rush teaches the garment of claim 1, yet does not explicitly disclose wherein the plurality of sensors includes a pulse oxygen sensor.
However, Bogdanovich teaches an analogous wearable health monitoring system which includes pulse oximeters (e.g. ¶52,61,148: garment 50 includes a HR monitor, which can be a pulse oximeter). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to incorporate a pulse oximeter in a device according to the teachings of Rush, as taught by Bogdanovich, in order to predictably measure oxygen saturation and/or heart rate which is an indicator of cardiovascular and respiratory health status (e.g. heart failure, pulse arrival time, arterial stiffness etc.).
Regarding Claim 6, Rush as modified in Claim 5, teaches the garment of claim 5, wherein the patient data includes pulse oxygen information of the user that is collected by the at least one pulse oxygen sensor (e.g. Bogdanovich: SpO2 and HR).
Regarding Claim 9, Rush teaches the garment of claim 1, yet does not explicitly disclose wherein the plurality of sensors includes one ultrasound sensor.
However, Bogdanovich teaches an analogous wearable health monitoring system which includes pulse oximeters (e.g. ¶52,54: garment 50 includes a HR monitor, which can include 3D sonography). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to incorporate 3D sonography, with ultrasonic transducers and sensors, in a device according to the teachings of Rush, as taught by Bogdanovich, in order to predictably provide 3D sonograms, which are valuable for a physician to assess a health status of a user (e.g. to evaluate atrophy, pericardial diseases, heart failure, cardiomyopathies etc.).
Regarding Claim 10, Rush as modified in Claim 9, teaches the garment of claim 9, wherein the patient data includes a visual representation of an internal organ of the user that is collected by at least one ultrasound sensor (e.g. Bogdanovich ¶52,54: garment 50 includes a HR monitor, which can include 3D sonography).
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Rush, as applied to Claim 1, in view of US 20210169326 by Emokpae.
Regarding Claim 9, Rush teaches the garment of claim 1, yet does not explicitly disclose wherein the plurality of sensors includes one ultrasound sensor.
However, Emokpae teaches an analogous wearable health monitoring system which includes an ultrasonic transducer imaging sensor (e.g. ¶21,27,31, 35, Fig. 1: garment 110 includes a ultrasonic organ imaging via ultrasonic transducer 111a and acoustic sensors 111b). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to incorporate ultrasonic transducers and sensors in a device according to the teachings of Rush, as taught by Emokpae, in order to predictably image muscle tissues and large body organs, which is desirable in tracking a patient’s progress in following a physical therapy plan, as taught by Empokpae (¶19), and is generally valuable for a physician to assess a health status of a user (e.g. to evaluate atrophy, pericardial diseases, heart failure, cardiomyopathies etc.).
Regarding Claim 10, Rush as modified in Claim 9, teaches the garment of claim 9, wherein the patient data includes a visual representation of an internal organ of the user that is collected by at least one ultrasound sensor (e.g. Emokpae: ¶21,27,31, 35, Fig. 1: garment 110 includes a ultrasonic organ imaging via ultrasonic transducer 111a and acoustic sensors 111b).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MANOLIS Y PAHAKIS whose telephone number is (571)272-7179. The examiner can normally be reached M-F 9-5, EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, CARL LAYNO can be reached at (571)272-4949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796
MANOLIS PAHAKIS /M.P./
Examiner
Art Unit 3792