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 Objections
Claims 1 and 2 are objected to because of the following informalities: Claim 1 recites “the clothes have a neckline encircles the neck” at Ln. 5, but should recite -- the clothes have a neckline that encircles the neck--. Appropriate correction is required.
Claim 2 recites a similar limitation at Ln. 5, and is objected to for the same reasons.
Claims 1-16 are objected to because of the following informalities: Claims 1-16 recite “is characterized,” but, as a matter of grammar, should not include this recitation. Appropriate correction is required.
Claim 14 is objected to because of the following informalities: Claim 14 recites “it comprises a mechanism can be detached” at Ln. 4, but should recite -- it comprises a mechanism that can be detached--. Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
In particular, the Claim 5 limitation “means for recording a predetermined event” is being interpreted under 35 USC 112(f).
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.
Claim 5 is 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.
Regarding Claim 5, Claim 5 recites “the lead includes three leads of the lead NASA….” The Present Specification provides no explanation of what the term “the lead NASA” entails. The term “the lead NASA” is not a term of art. Claim 5 thus 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 had possession of the claimed invention at the time the application was filed.
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, 2, 5, 7-10, 12-14, and Claims 3-4 and 11 by dependency, 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 Independent Claim 1:
Claim 1 recites “An electrocardiographic testing method of the two or more-lead using the clothes comprises at least the three measurement electrodes or a measurement electrode attachment part and a connector part for fixing a measurement device….” It is grammatically unclear in what sense this limits Claim 1.
For purposes of this Office Action, the above limitation is being interpreted as a preamble statement limiting the structure of “the clothes” upon which the remainder of the method claim relies.
Claim 1 recites “the first measurement electrode or its measurement electrode mounting part is arranged within a circle with a radius of 5cm is centered around a position that 7.5 to 15cm downward from a center point of a straight line connecting to vertices of a left and a right of the neckline.” It is grammatically unclear in what sense this limits Claim 1. For example, it is unclear whether “the first measurement electrode” is positioned within an area defined by a radius of 5 cm from a particular point, or whether a particular structural element is a circle with a radius of 5 cm. It is additionally unclear whether “the first measurement electrode” is “centered around a position that 7.5 to 15cm downward” or whether the “a circle” is so-centered.
For purposes of this Office Action, the limitation “the first measurement electrode or its measurement electrode mounting part is arranged within a circle with a radius of 5cm is centered around a position that 7.5 to 15cm downward from a center point of a straight line connecting to vertices of a left and a right of the neckline” is being interpreted to mean that “the first measurement electrode” is positioned within an area defined by a radius of 5 cm, and the circle is “centered around a position that 7.5 to 15cm downward.”
Claim 1 recites “the clothes have at least two or more different sizes.” It is unclear how the singular item “the clothes” can have “at least two or more different sizes.”
Claim 1 recites “a position that 7.5 to 15cm downward from a center point of a straight line connecting to vertices of a left and a right of the neckline.” However, Claim 1 additionally recites “the clothes have a neckline encircles the neck.” Claim 1 appears to recite the “neckline” being a circle, and to define a distance based on the vertices of that circle. However, circles do not have vertices.1 It is therefore unclear what the recited “a position” is “7.5 to 15cm downward” from.
If the limitation “the clothes have a neckline encircles the neck” does not impose a shape of the “neckline,” a similar issue arises.
Relatedly, as it is unclear what the recited “a position” is “7.5 to 15cm downward” from, it is unclear what the “a circle with a radius of 5cm is centered around.”
For purposes of this Office Action, the term “the first measurement electrode or its measurement electrode mounting part is arranged within a circle with a radius of 5cm is centered around a position that 7.5 to 15cm downward from a center point of a straight line connecting to vertices of a left and a right of the neckline.” is being interpreted to mean “below the neckline.”
The Examiner notes that the particular distances recited appear to amount only to routine optimization.
Claim 1 recites “when the height is H and the vertical distance between the first measurement electrode and the fifth intercostal assumed height is D, H and D satisfy the relationship of the following formula [A], is characterized, (Math. 1)D = [(H - 119.390) / 2.47] ± 5.0 [A].” It is unclear in what sense this limitation further limits Claim 1, as it is unclear what claim elements are related by the recited “the following formula [A].”
The above limitation appears to relate the position of the recited “first measurement electrode” and “the fifth intercostal assumed height.” However, Claim 1 appears to recite the “first measurement electrode” as being incorporated into “the clothes” (the Present Drawings, e.g., Fig. 12, appear to support this interpretation). The term “the fifth intercostal assumed height” is not defined by the claim, but appears from Paras. [0023] through [0024] of the Present Specification to indicate an anatomical point on the patient wearing “the clothes.” It is thus unclear whether “the following formula [A]” pertains to the distance of the “first measurement electrode” to the fifth intercostal space when the patient is wearing the clothes, or to something else.
It is additionally unclear whether “the following formula [A]” is intended to impose a limitation on the position of the “first measurement electrode” on “the clothes,” particularly in view of the Claim 1 limitation “the first measurement electrode or its measurement electrode mounting part is arranged within a circle with a radius of 5cm is centered around a position that 7.5 to 15cm downward from a center point of a straight line connecting to vertices of a left and a right of the neckline,” which appears to itself precisely define the position of the “first measurement electrode” on “the clothes.”
For purposes of this Office Action, the limitation “when the height is H and the vertical distance between the first measurement electrode and the fifth intercostal assumed height is D, H and D satisfy the relationship of the following formula [A], is characterized, (Math. 1)D = [(H - 119.390) / 2.47] ± 5.0 [A]” is being interpreted to mean that the distance on “the clothes” from “the first measurement electrode” to a point on the clothes which lies (during use) at “the fifth intercostal assumed height” satisfies the relationship “D = [(H - 119.390) / 2.47] ± 5.0 [A].”
Regarding Independent Claim 2, Claims 2 recites similar limitations to those explained above with respect to Claim 1, which are indefinite for the same reasons.
Regarding Claim 5:
Claim 5 recites “wherein, the lead includes three leads of the lead NASA, the lead CM5, and the lead CC5, is characterized.” It is grammatically unclear in what sense this limitation further limits Claim 1. For example, it is unclear whether a particular configuration is used, whether three types of leads are used, or something else.
For purposes of this Office Action, the above limitation is being interpreted to mean that “the lead NASA, the lead CM5, and the lead CC5” are all used.
Claim 5 recites “the lead NASA.” There is insufficient antecedent basis for this limitation.
Claim 5 recites “the lead CM5.” There is insufficient antecedent basis for this limitation
Claim 5 recites “the lead CC5.” There is insufficient antecedent basis for this limitation.
Further regarding Claim 5, the Claim 5 limitation “means for recording a predetermined event” 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. 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. Applicant may:
Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Regarding Claim 7, Claim 7 recites “about the step of informing to the patient whether the clothes and the measurement device are correctly put, informing to the patient at least one of a vibration, a light, and a sound from the measurement device or a terminal wirelessly communicating with the measurement device, is characterized.”
It is grammatically unclear what is meant by the phrase “about the step of informing to the patient whether the clothes and the measurement device are correctly put.”
For purposes of this Office Action, the above is being interpreted to mean that informing the patient additionally includes the subsequent recitations.
It is grammatically unclear what is meant by “informing to the patient at least one of a vibration, a light, and a sound.”
For purposes of this Office Action, the above is being interpreted to mean that informing the patient may be done by vibration, light, or sound.
Regarding Claim 8:
Claim 8 recites “a data obtained by the electrocardiogram measurement is transmitted and recorded to a server directly from the measurement device or via the terminal wirelessly communicates with the measurement device, is characterized.” It is grammatically unclear what the term “from the measurement device or via the terminal wirelessly communicates with the measurement device” modifies. For example, the term “from the measurement device or via the terminal wirelessly communicates with the measurement device” could modify where the data originates, from where the data is sent, or something else.
For purposes of this Office Action, the above limitation is being interpreted to mean that the device sends data obtained by the device to either a server or wireless communication device.
Claim 8 recites “the terminal.” There is insufficient antecedent basis for this limitation.
Regarding Claim 9, Claim 9 recites “the data obtained by the electrocardiographic measurement is recorded on a recording medium within a device.” It is unclear whether the “a device” is the “a measurement device” of Claim 1, or a different device.
For purposes of this Office Action, the term “a device” is being interpreted to mean the measurement device.
Regarding Claim 10, Claim 10 recites “the terminal.” There is insufficient antecedent basis for this limitation.
Regarding Claim 12, Claim 12 recites “wherein, about a wiring for connecting the measurement electrode or the measurement electrode attachment part and the connector part, when an extension is extended by 20% from the original wiring length, an electrical resistivity increases from 0 to 30%, is characterized.” It is grammatically unclear in what sense this limitation further limits Claim 1.
It is grammatically unclear what is meant by “about a wiring for connecting….”
It is grammatically unclear what is meant by “when an extension is extended by 20% from the original wiring length, an electrical resistivity increases from 0 to 30%.” For example, it is unclear what an “extension” is intended to reference, and what is contemplated to undergo an electrical resistivity increase. It is additionally unclear whether “from 0 to 30%” is a range of increase, or a beginning point and ending point detailing the increase.
For purposes of this Office Action, the above limitation is being interpreted to mean that the clothes incorporate some element of the clothes is capable of undergoing an increase in electrical resistivity upon stretching.
Regarding Claim 13, Claim 13 recites “wherein, about a fabric used in a range of 10 cm downward and 5 cm wide from the first measurement electrode or the measurement electrode attachment part, when the vertical direction 4.9N is loaded, an extension rate is 160% or less, is characterized.” It is grammatically unclear in what sense this limitation further limits Claim 1.
It is unclear what the term “about a fabric used” is intended to modify or further limit.
It is unclear what the term “range” in the phrase “used in a range of 10 cm downward and 5 cm wide” is intended to reference.
It is unclear what the terms “downward” and “wide” in the phrase “used in a range of 10 cm downward and 5 cm wide” pertain to.
It is unclear what the term “when the vertical direction 4.9N is loaded” is in reference to.
It is unclear what “an extension rate is 160% or less” is an extension rate of.
For purposes of this Office Action, Claim 13 is being interpreted to mean that the fabric is capable of being stretch by 160% or less.
Regarding Claim 14, Claim 14 recites “wherein, about a part of the clothes including a portion for the measurement electrode or the measurement electrode attachment part is attached, it comprises a mechanism can be detached in a whole or in the part from the clothes, is characterized.” It is grammatically unclear in what sense this limitation further limits Claim 1.
It is unclear what the term “about a part of the clothes” modifies or further limits.
It is unclear what the term “it” (i.e., “it comprises”) is in reference to.
It is unclear whether a mechanism that can be detached or a mechanism that facilitates detachment of the measurement electrode/the measurement electrode attachment part is contemplated.
For purposes of this Office Action, Claim 14 is being interpreted to require that the clothes include a mechanism that facilitates electrode detachment.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 2, 4, 8-10, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over US 20110004088 A1 to Grossman et al. (“Grossman”) in view of WO 2020/205853 A1 to Ganesan et al. (“Ganesan”) and GOKSIN NILUFER YONGUC et al., "Estimation of stature and sex from sternal lengths: an autopsy study", Anatomical Science International, Blackwell Publishing, GB, Vol. 90, No. 2, April 19, 2014, pages 89-96, 8 pp.2 (“Goksin”).
Regarding Independent Claim 1, Grossman teaches:
An electrocardiographic testing method of the two or more-lead (Abstract, “ The ECG Shirt facilitates not only twelve lead resting ECG testing but also exercise testing, monitoring, fifteen lead, and two different types of eighteen lead ECG testing. The ECG Shirt is a tool for teaching expert ECG electrode lead placement.”);
using the clothes comprises at least the three measurement electrodes or a measurement electrode attachment part and a connector part for fixing a measurement device, (Fig. 6, see Annotated Fig. 6, below);
the clothes have at least two or more different sizes, (Para. [0020], “There are child, male, and female sizes for people to eliminate the need for shaving hair to stick the electrode leads to the skin.”);
the clothes have a neckline that encircles the neck, (Fig. 6, see Annotated Fig. 6, below);
the first measurement electrode or its measurement electrode mounting part is arranged within a circle with a radius of 5cm is centered around a position that 7.5 to 15cm downward from a center point of a straight line connecting to vertices of a left and a right of the neckline (Fig. 6, see Annotated Fig. 6, below);
As explained above, the limitation “the first measurement electrode or its measurement electrode mounting part is arranged within a circle with a radius of 5cm is centered around a position that 7.5 to 15cm downward from a center point of a straight line connecting to vertices of a left and a right of the neckline” is being interpreted to mean that “the first measurement electrode” is positioned within an area defined by a radius of 5 cm, and the circle is “centered around a position that 7.5 to 15cm downward.”
As explained above, the term the term “the first measurement electrode or its measurement electrode mounting part is arranged within a circle with a radius of 5cm is centered around a position that 7.5 to 15cm downward from a center point of a straight line connecting to vertices of a left and a right of the neckline.” is being interpreted to mean “below the neckline.”
Grossman’s measurement electrodes are placed below the neckline.
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having the following steps: (1) a step of obtaining a physique information of a patient; (Para. [0039], “The brassiere is an embodiment of Claim 1 except with a design supporting, cupping, raising, and separating larger fatty breasts common with women. It is also helpful for obese men that may have large breast;” Para. [0020], “There are child, male, and female sizes for people to eliminate the need for shaving hair to stick the electrode leads to the skin.”);
Grossman’s device is differently sized based on whether its wearer is a child, a male or a female, and additionally based on its wearer’s breast size. Age (i.e., whether the wearer is a child), gender (i.e., whether the wearer is male or female) and breast size are all physique information.
(2) a step of selecting a size of clothes according to the physique information of the patient; (Para. [0039]; Para. [0020]);
As noted above, Grossman’s device is differently sized based on whether its wearer is a child, a male or a female, and additionally based on its wearer’s breast size. Each of these criteria are physique information. The appropriate size of Grossman’s device is determined (i.e., selected) based on this physique information. Use Grossman’s device in accordance with Grossman’s disclosed sizing is such “a step of selecting a size of clothes according to the physique information of the patient” as claimed.
Grossman does not disclose:
(3) a step of giving the selected clothes and the measuring device to the patient;
(4) a step of the patient puts on the clothes and the measurement device;
and (5) a step of starting the electrocardiogram measurement;
Wherein, the physique information includes a height,
when the height is H and the vertical distance between the first measurement electrode and the fifth intercostal assumed height is D, H and D satisfy the relationship of the following formula [A], is characterized, (Math. 1)D = [(H - 119.390) / 2.47] ± 5.0 [A].
Ganesan describes a “Physiological sensing textile apparatus” (Title). Ganesan is analogous art.
Ganesan teaches:
(3) a step of giving the selected clothes and the measuring device to the patient; (Para. [0141], “The participants wore an example of the garment system 10 in various stationary conditions and the output voltage was recorded;” Para. [0142], “The first group included participants for whom the XL sized garment 12 fits relatively well, and the second group included those participants who are generally too short to wear the XL sized garment 12.”);
Ganesan’s “Performance Study” detailed at Ganesan’s Paras. [0139] through [0144] describe a testing process in which participants were given Ganesan’s garment for testing. This “Performance Study” equates to the recited method steps.
(4) a step of the patient puts on the clothes and the measurement device; (Para. [0141], “The participants wore an example of the garment system 10 in various stationary conditions and the output voltage was recorded.”);
and (5) a step of starting the electrocardiogram measurement; (Para. [0144], “The duration of each measurement for each of the tested postures was for one (1) minute, for a total of eight (8) minutes of recording from each individual participant.”);
Wherein, the physique information includes a height, (Para. [0142], “The first group included participants for whom the XL sized garment 12 fits relatively well, and the second group included those participants who are generally too short to wear the XL sized garment 12. For the sake of brevity, the first group of participants are referred to hereinafter as “height matched” participants and the second group or participants are referred to hereinafter as “height unmatched,” respectively.”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Grossman with the teachings of Ganesan (i.e., to modify the method of Grossman such that it further includes giving the selected clothes to the patient, the patient putting on the clothes, and starting the electrocardiogram measurement in the manner of Ganesan) in order to “ evaluate and validate the performance of the garment system” (Ganesan at Para. [0139]).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Grossman with the teachings of Ganesan (i.e., to include such height information as taught by Ganesan in the physique information obtained by Grossman) because “results are better for the height-matched participants compared to the height-unmatched participants” (Ganesan at Para. [0152]).
Goksin describes “Estimation of stature and sex from sternal lengths…” (Title). Goksin is reasonably pertinent to the problem faced by the inventor, and is thus analogous art. MPEP 2141.01(a).
The problem faced by the inventor is “…positioning work of the measurement electrode based on the physique information” (Present Specification at Para. [0011]) in the context of “Holter electrocardiograph[s]” (Present Specification at Para. [0010]). Goksin is concerned with precisely such “physique information,” as Goskin seeks to “investigate whether a correlation exists between stature and four measured sternal lengths to develop regression equations for stature estimation from the sternal lengths” and “to find metric values for differentiating between male and female sterna.” (Goskin at Pg. 90, Right Column, Third Paragraph). Goskin would thus “logically [] have commended itself to an inventor's attention in considering his problem” of positioning electrodes on the chest based on physique information.
Goskin teaches:
when the height is H and the vertical distance between the first measurement electrode and the fifth intercostal assumed height is D, H and D satisfy the relationship of the following formula [A], is characterized, (Math. 1)D = [(H - 119.390) / 2.47] ± 5.0 [A] (Pg. 93, Table 2; see Annotated Table 2, below).
As explained above, for purposes of this Office Action, the limitation “when the height is H and the vertical distance between the first measurement electrode and the fifth intercostal assumed height is D, H and D satisfy the relationship of the following formula [A], is characterized, (Math. 1)D = [(H - 119.390) / 2.47] ± 5.0 [A]” is being interpreted to mean that the distance on “the clothes” from “the first measurement electrode” to a point on the clothes which lies (during use) at “the fifth intercostal assumed height” satisfies the relationship “D = [(H - 119.390) / 2.47] ± 5.0 [A].”
Goksin’s “X4: total sternal length” is equal to “D” as defined by the formula of Claim 1 when mathematically rearranged to isolate “X4.”
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Goksin does not disclose the general formula “[(H - 119.390) / 2.47] ± 5.0.” However, the claimed formula “[(H - 119.390) / 2.47] ± 5.0” described a range that lies inside the two length relationships described by Goksin at Table 2 for males and females. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In reWertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to select any range within Goksin’s range of female to male lengths, including the claimed range, as doing so would likely result in success and involves only routine optimization.
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of combined Grossman and Ganesan with the teachings of Goksin (i.e., to relate the distance on “the clothes” from “the first measurement electrode” to a point on the clothes which lies (during use) at “the fifth intercostal assumed height” satisfies the relationship “D = [(H - 119.390) / 2.47] ± 5.0 [A]) in order to facilitate consistent placement relative the sternum (see Goksin at Fig. 2).
Regarding Independent Claim 2, Grossman teaches:
An electrocardiographic testing method of the two or more-lead (Abstract, “ The ECG Shirt facilitates not only twelve lead resting ECG testing but also exercise testing, monitoring, fifteen lead, and two different types of eighteen lead ECG testing. The ECG Shirt is a tool for teaching expert ECG electrode lead placement.”);
using the clothes comprises at least the three measurement electrodes or a measurement electrode attachment part and a connector part for fixing a measurement device, (Fig. 6, see Annotated Fig. 6, above);
the clothes have at least two or more different sizes, (Para. [0020], “There are child, male, and female sizes for people to eliminate the need for shaving hair to stick the electrode leads to the skin.”);
the clothes have a neckline encircles the neck, (Fig. 6, see Annotated Fig. 6, above);
the first measurement electrode or its measurement electrode mounting part is arranged within a circle with a radius of 5cm is centered around a position that 7.5 to 15cm downward from a center point of a straight line connecting to vertices of a left and a right of the neckline, (Fig. 6, see Annotated Fig. 6, above);
This limitation is being interpreted similarly to the similar limitation of Claim 1.
having the following steps: (1) a step of obtaining a physique information of a patient; (Para. [0039]; Para. [0020]);
This limitation is being interpreted similarly to the similar limitation of Claim 1.
(2) a step of selecting a size of clothes according to the physique information of the patient; (Para. [0039]; Para. [0020]);
This limitation is being interpreted similarly to the similar limitation of Claim 1.
Grossman does not disclose:
(3) a step of giving the selected clothes and the measuring device to the patient;
(4) a step of the patient puts on the clothes and the measurement device;
and (5) a step of starting the electrocardiogram measurement;
wherein, the physique information includes the height,
when the height is H and the vertical distance between the first measurement electrode and the fifth intercostal assumed height is D, H and D satisfy the following formula [B] when the patient is a male, and the following formula [C] when the patient is a female, is characterized, (Math. 2) D = [(H - 126.388) / 2.23] ± 5.0 [B] (Math. 3)D = [(H - 110.713) / 2.76] ± 5.0 [C].
Ganesan describes a “Physiological sensing textile apparatus” (Title). Ganesan is analogous art.
Ganesan teaches:
(3) a step of giving the selected clothes and the measuring device to the patient; (Para. [0141]);
This limitation is being interpreted similarly to the similar limitation of Claim 1.
(4) a step of the patient puts on the clothes and the measurement device; (Para. [0141]);
and (5) a step of starting the electrocardiogram measurement; (Para. [0144]);
wherein, the physique information includes the height, (Para. [0142]).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Grossman with the teachings of Ganesan (i.e., to modify the method of Grossman such that it further includes giving the selected clothes to the patient, the patient putting on the clothes, and starting the electrocardiogram measurement in the manner of Ganesan) in order to “ evaluate and validate the performance of the garment system” (Ganesan at Para. [0139]).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Grossman with the teachings of Ganesan (i.e., to include such height information as taught by Ganesan in the physique information obtained by Grossman) because “results are better for the height-matched participants compared to the height-unmatched participants” (Ganesan at Para. [0152]).
Goksin describes “Estimation of stature and sex from sternal lengths…” (Title). Goksin is reasonably pertinent to the problem faced by the inventor, and is thus analogous art as explained above with respect to Claim 1. MPEP 2141.01(a).
Goskin teaches:
when the height is H and the vertical distance between the first measurement electrode and the fifth intercostal assumed height is D, H and D satisfy the following formula [B] when the patient is a male, and the following formula [C] when the patient is a female, is characterized, (Math. 2) D = [(H - 126.388) / 2.23] ± 5.0 [B] (Math. 3)D = [(H - 110.713) / 2.76] ± 5.0 [C]. (Pg. 93, Table 2; see Annotated Table 2, above).
Goksin’s “X4: total sternal length” is equal to “D” as defined by the formula of Claim 2 when mathematically rearranged to isolate “X4.” Goksin’s “male” formula corresponds to the claimed male formula [B], and Goksin’s “female” formula corresponds to the claimed female formula [C].
This limitation is being interpreted similarly to the similar limitation of Claim 1.
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of combined Grossman and Ganesan with the teachings of Goksin (i.e., to relate the distance on “the clothes” from “the first measurement electrode” to a point on the clothes which lies (during use) at “the fifth intercostal assumed height” satisfies the relationship “D = [(H - 119.390) / 2.47] ± 5.0 [A]) in order to facilitate consistent placement relative the sternum (see Goksin at Fig. 2).
Regarding Claim 4, the combination of Grossman, Ganesan and Goksin renders obvious the entirety of Claim 1 as explained above.
Grossman additionally teaches:
wherein, the physique information further includes at least one of a body weight, a chest circumference, and an abdominal circumference, is characterized (Para. [0039], “The brassiere is an embodiment of Claim 1 except with a design supporting, cupping, raising, and separating larger fatty breasts common with women. It is also helpful for obese men that may have large breast).
Regarding Claim 8, the combination of Grossman, Ganesan and Goksin renders obvious the entirety of Claim 1 as explained above.
Ganesan additionally teaches:
wherein, in the electrocardiographic testing method, a data obtained by the electrocardiogram measurement is transmitted and recorded to a server directly from the measurement device or via the terminal wirelessly communicates with the measurement device, is characterized (Abstract, “The system also includes electronics configured to process signals from the distributed array of resistive pressure sensors to determine one or more physiological properties of a wearer of the garment substrate;” Para. [00144])
Regarding Claim 9, the combination of Grossman, Ganesan and Goksin renders obvious the entirety of Claim 1 as explained above.
Ganesan additionally teaches:
wherein, the data obtained by the electrocardiographic measurement is recorded on a recording medium within a device, is characterized (Abstract, “The system also includes electronics configured to process signals from the distributed array of resistive pressure sensors to determine one or more physiological properties of a wearer of the garment substrate;” Para. [00144])
Regarding Claim 10, the combination of Grossman, Ganesan and Goksin renders obvious the entirety of Claim 1 as explained above.
Ganesan additionally teaches:
wherein, in the electrocardiographic testing method, the measuring device or the terminal wirelessly communicating with the measuring device includes means for recording a predetermined event, is characterized (Abstract, “The system also includes electronics configured to process signals from the distributed array of resistive pressure sensors to determine one or more physiological properties of a wearer of the garment substrate;” Para. [00144]; Paras. [0130] through [0131], describing “J-Peak classification;” Para. [0130], “The next stage of the signal processing pipeline 60 classifies the candidate peaks into valid or invalid BCG J-peaks.”).
Regarding Claim 14, the combination of Grossman, Ganesan and Goksin renders obvious the entirety of Claim 1 as explained above.
Grossman additionally teaches:
about a part of the clothes including a portion for the measurement electrode or the measurement electrode attachment part is attached, it comprises a mechanism can be detached in a whole or in the part from the clothes, is characterized (Para. [0037], “Twenty-one thin elastic straps (56) are sewn or fastened externally that fasten the electrode clips to the ECG Shirt.”).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over US 20110004088 A1 to Grossman et al. (“Grossman”) in view of WO 2020/205853 A1 to Ganesan et al. (“Ganesan”) and GOKSIN NILUFER YONGUC et al., "Estimation of stature and sex from sternal lengths: an autopsy study", Anatomical Science International, Blackwell Publishing, GB, Vol. 90, No. 2, April 19, 2014, pages 89-96, 8 pp. (“Goksin”) as applied to Claim 1 above, and further in view of US 2018/0000415 A1 to Gupta et al. (“Gupta”)
Regarding Claim 3, the combination of Grossman, Ganesan and Goksin renders obvious the entirety of Claim 1 as explained above.
Ganesan additionally teaches:
and (9) a step of checking the operation of the clothes and the device, is characterized. (Para. [0139[, “User studies were conducted to evaluate and validate the performance of the garment system 10”).
The combination of Grossman, Ganesan and Goksin does not disclose
wherein, after the step of (5) is completed, having following a series of steps: (6) a step of the patient returns the clothes and the device;
(7) a step of reporting the electrocardiogram testing results to the patient;
(8) a step of washing the clothes;
Gupta describes “…self-operable (or self-assisted) bio-signal (e.g., vital signs) monitoring of multi-channel, multi-modal bio-signals including electroencephalography (EEG), electrocardiography (ECG), electromyography (EMG), and electrooculography (EOG)” (Para. [0001]). Gupta is analogous art.
Gupta teaches:
wherein, after the step of (5) is completed, having following a series of steps: (6) a step of the patient returns the clothes and the device; (Para. [0099], “…, an advantageous aspect of some embodiments is utilization of reusable, flexible and even machine-washable electronic textile wear suitable for both adolescents and adults.”);
(7) a step of reporting the electrocardiogram testing results to the patient; (Para. [0062], “An exemplary output device 405 is a monitor or screen, for example. Other alternative output devices that can be used in place or in addition to a monitor or screen include a projector, one or more speakers, or one or more tactile feedback devices. In other words, the results of the comparison can be provided as any of one or more of visual, auditory, and tactile forms of feedback.”);
(8) a step of washing the clothes; (Para. [0099], “…, an advantageous aspect of some embodiments is utilization of reusable, flexible and even machine-washable electronic textile wear suitable for both adolescents and adults.”););
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the combined Grossman, Ganesan and Goksin with the teachings of Gupta (i.e., to re-use and machine wash the clothes post-use in the manner of Gupta) in order to prevent “skin irritation, discomfort, and rashes” associated with prolonged use (Gupta at Para. [0003]).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the combined Grossman, Ganesan and Goksin with the teachings of Gupta (i.e., to report the electrocardiogram testing results to the patient in the manner of Gupta) in order to provide the patient with feedback regarding testing (Gupta at Para. [0062]).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over US 20110004088 A1 to Grossman et al. (“Grossman”) in view of WO 2020/205853 A1 to Ganesan et al. (“Ganesan”) and GOKSIN NILUFER YONGUC et al., "Estimation of stature and sex from sternal lengths: an autopsy study", Anatomical Science International, Blackwell Publishing, GB, Vol. 90, No. 2, April 19, 2014, pages 89-96, 8 pp. (“Goksin”) as applied to Claim 1 above, and further in view of NTRS - NASA Technical Reports Server, "Wireless Self-Acquistion of 12-Lead ECG via Android Smart Phone," Accessed online on 1/6/2025 at https://ntrs.nasa.gov/citations/20120004093; January 1, 2012 (“NTRS”) and Huang JY, Yang SH, Gu FS. [Evaluation of 3 chest leads CM5, CC5, and CL5 and factors which influence the results]. Zhonghua Xin Xue Guan Bing Za Zhi. 1989 Apr;17(2):103-6, 127-8. Chinese. PMID: 2791875. (Abstract Only) (“Huang”).
Regarding Claim 5, the combination of Grossman, Ganesan and Goksin renders obvious the entirety of Claim 1 as explained above
The combination of Grossman, Ganesan and Goksin does not disclose:
the lead includes three leads of the lead NASA, the lead CM5, and the lead CC5, is characterized.
NTRS describes “…a dry-electrode harness that allows for self-acquisition of resting 12-lead ECGs by minimally trained laypersons” (Pg. 1 of 2, First Paragraph). NTRS is analogous art.
NTRS teaches:
the lead includes three leads of the lead NASA… (Pg. 1 of 2, First Paragraph, “Researchers at NASA s Johnson Space Center and at Orbital Research, Inc. (a NASA SBIR grant recipient) have recently developed a dry-electrode harness that allows for self-acquisition of resting 12-lead ECGs by minimally trained laypersons.”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify combined Grossman, Ganesan and Goksin with the teachings of NTRS (i.e., to use such a “lead NASA” as taught by NTRS) because such a modification entails a simple substitution of one known element for another to obtain predictable results.
The prior art contains a device (i.e., the device of combined Grossman, Ganesan and Goksin) which differed from the claimed device by the substitution of some components (i.e., an unspecified lead) with other components (i.e., a “lead NASA”).
The substituted components and their functions were known in the art. For example NTRS describes such a “lead NASA” at Pg. 1, First Paragraph.
One of ordinary skill in the art could have substituted one known element for another, and the results of the substitution would have been predictable.
Huang describes “Evaluation of 3 chest leads CM5, CC5, and CL5 and factors which influence the results” (Title). Huang is analogous art.
Huang teaches:
the lead includes three leads of … the lead CM5, and the lead CC5, is characterized (Abstract).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify combined Grossman, Ganesan, Goksin and NTRS with the teachings of Huang (i.e., to use such a “the lead CM5, and the lead CC5” as taught by Huang) because such a modification entails a simple substitution of one known element for another to obtain predictable results.
The prior art contains a device (i.e., the device of combined Grossman, Ganesan and Goksin) which differed from the claimed device by the substitution of some components (i.e., an unspecified lead) with other components (i.e., a “the lead CM5, and the lead CC5””).
The substituted components and their functions were known in the art. For example Huang describes such a “the lead CM5, and the lead CC5” at Huang’s Abstract.
One of ordinary skill in the art could have substituted one known element for another, and the results of the substitution would have been predictable
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over US 20110004088 A1 to Grossman et al. (“Grossman”) in view of WO 2020/205853 A1 to Ganesan et al. (“Ganesan”) and GOKSIN NILUFER YONGUC et al., "Estimation of stature and sex from sternal lengths: an autopsy study", Anatomical Science International, Blackwell Publishing, GB, Vol. 90, No. 2, April 19, 2014, pages 89-96, 8 pp. (“Goksin”) as applied to Claim 1 above, and further in view of US 20110288605 A1 to Kaib et al. (“Kaib”).
Regarding Claim 6, the combination of Grossman, Ganesan and Goksin renders obvious the entirety of Claim 1 as explained above.
The combination of Grossman, Ganesan and Goksin does not disclose:
wherein, the step (5) of starting the electrocardiogram measurement includes a step of informing to the patient whether the clothes and the measurement device are correctly put, is characterized.
Kaib describes a “WEARABLE AMBULATORY MEDICAL DEVICE WITH MULTIPLE SENSING ELECTRODES” (Title). Kaib is analogous art.
Kaib teaches:
wherein, the step (5) of starting the electrocardiogram measurement includes a step of informing to the patient whether the clothes and the measurement device are correctly put, is characterized. (Para. [0007], “When there is noise or fall-off, the device issues alarms so that the patient can take action to correct the problem.“)
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify combined Grossman, Ganesan and Goksin with the teachings of Kaib (i.e., to further include in the method of combined Grossman, Ganesan and Goksin a step of informing to the patient whether the clothes and the measurement device are correctly put in the manner of Kaib) in order to allow the patient to take action to correct the problem (Kaib at Para. [0007]).
Regarding Claim 7, the combination of Grossman, Ganesan and Goksin renders obvious the entirety of Claim 6 as explained above.
Kaib additionally teaches:
wherein, about the step of informing to the patient whether the clothes and the measurement device are correctly put, informing to the patient at least one of a vibration, a light, and a sound from the measurement device or a terminal wirelessly communicating with the measurement device, is characterized (Para. [0007]).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over US 20110004088 A1 to Grossman et al. (“Grossman”) in view of WO 2020/205853 A1 to Ganesan et al. (“Ganesan”) and GOKSIN NILUFER YONGUC et al., "Estimation of stature and sex from sternal lengths: an autopsy study", Anatomical Science International, Blackwell Publishing, GB, Vol. 90, No. 2, April 19, 2014, pages 89-96, 8 pp. (“Goksin”) as applied to Claim 1 above, and further in view of US 2008/0027341 A1 to Sackner et al. (“Sackner”).
Regarding Claim 11, the combination of Grossman, Ganesan and Goksin renders obvious the entirety of Claim 1 as explained above.
The combination of Grossman, Ganesan and Goksin does not disclose:
wherein, in the electrocardiographic testing method, it is also recorded an exercise data obtained from at least one of an acceleration sensor and a gyro sensor, is characterized.
Sackner describes “systems for testing a subject for the presence of ischemic heart disease including a stressor for causing physiological stress in the subject…” (Para. [0008]), the preferred embodiment of which is “a half-shirt, or vest, or similar, includes at least two IP sensor bands 203 along with other sensor types, principally ECG electrodes 205, and accelerometers (positioned under the anterior flap and accordingly not illustrated), and the like” (Para. [0037]). Sackner is analogous art.
Sackner teaches:
wherein, in the electrocardiographic testing method, it is also recorded an exercise data obtained from at least one of an acceleration sensor and a gyro sensor, is characterized. (Para. [0037]; Para. [0098], “ Accelerometer information can aid in quantization of the level of exercise.”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Grossman, Ganesan and Goksin with the teachings of Sackner (i.e., to include in the method of Grossman, Ganesan and Goksin such an accelerometer as taught by Sackner and to record exercise data therewith) in order to facilitate cardiac stress testing (Sackner at Para. [0098]).
Claims 12 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over US 20110004088 A1 to Grossman et al. (“Grossman”) in view of WO 2020/205853 A1 to Ganesan et al. (“Ganesan”) and GOKSIN NILUFER YONGUC et al., "Estimation of stature and sex from sternal lengths: an autopsy study", Anatomical Science International, Blackwell Publishing, GB, Vol. 90, No. 2, April 19, 2014, pages 89-96, 8 pp. (“Goksin”) as applied to Claim 1 above, and further in view of US 20180085060 A1 to Boaz et al. (“Boaz”).
Regarding Claim 12, the combination of Grossman, Ganesan and Goksin renders obvious the entirety of Claim 1 as explained above.
The combination of Grossman, Ganesan and Goksin does not disclose:
wherein, about a wiring for connecting the measurement electrode or the measurement electrode attachment part and the connector part, when an extension is extended by 20% from the original wiring length, an electrical resistivity increases from 0 to 30%, is characterized.
Boaz describes “an elastic smart garment … , for sensing electrical vital signals, such as a clinical level ECG signal” (Abstract). Boaz is analogous art.
Boaz teaches:
wherein, about a wiring for connecting the measurement electrode or the measurement electrode attachment part and the connector part, when an extension is extended by 20% from the original wiring length, an electrical resistivity increases from 0 to 30%, is characterized. (Para. [0048], “When a conductive stripe is stretched in length by up to 15%, the electric resistance of the conductive stripe increases by less than 25%, with respect to the non-stretched, rest state of the conductive stripe. When the conductive stripe is further stretched in length beyond the 15% and up to 30% of the rest state sate length, the electric resistance increases by less than 10%, with respect to the non-stretched, rest state of the conductive stripe. When the conductive stripe is further stretched in length beyond the 30% of the rest state sate length, the electric resistance increases by less than 5%, with respect to the non-stretched, rest state of the conductive stripe.”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify combined Grossman, Ganesan and Goksin with the teachings of Boaz (i.e., to include such a conductive strip as taught by Boaz in the device of Grossman, Ganesan and Goksin) in order to facilitate good conductivity during use when the clothes are stretched (Boaz at Para. [0012]).
Regarding Claim 13, the combination of Grossman, Ganesan and Goksin renders obvious the entirety of Claim 1 as explained above.
The combination of Grossman, Ganesan and Goksin does not disclose:
wherein, about a fabric used in a range of 10 cm downward and 5 cm wide from the first measurement electrode or the measurement electrode attachment part, when the vertical direction 4.9N is loaded, an extension rate is 160% or less, is characterized.
Boaz is analogous art as explained above.
Boaz teaches:
wherein, about a fabric used in a range of 10 cm downward and 5 cm wide from the first measurement electrode or the measurement electrode attachment part, when the vertical direction 4.9N is loaded, an extension rate is 160% or less, is characterized. (Para. [0048], “When a conductive stripe is stretched in length by up to 15%, the electric resistance of the conductive stripe increases by less than 25%, with respect to the non-stretched, rest state of the conductive stripe. When the conductive stripe is further stretched in length beyond the 15% and up to 30% of the rest state sate length, the electric resistance increases by less than 10%, with respect to the non-stretched, rest state of the conductive stripe. When the conductive stripe is further stretched in length beyond the 30% of the rest state sate length, the electric resistance increases by less than 5%, with respect to the non-stretched, rest state of the conductive stripe.”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify combined Grossman, Ganesan and Goksin with the teachings of Boaz (i.e., to accommodate stretching of less than 160% in the manner of Boaz) in order to facilitate good conductivity during use (Boaz at Para. [0012])
Conclusion
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/C.J.M./Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796
1 See, e.g., Jill Padfield, "What Are Vertices?" dreambox.com, published Oct. 2024, accessed online on 1/6/2026 at https://www.dreambox.com/math/skills/geometry/what-are-vertices#:~:text=Some%20shapes%20won't%20have %20vertices%20%E2%80%93%20Circles%2C,means%20that%20there%20are%20no%20intersection%20points at Pg. 1 (“Some shapes won’t have vertices – Circles, for example, have no vertices since they do not have any straight lines that come together — which means that there are no intersection points.”).
2 GOKSIN NILUFER YONGUC et al., "Estimation of stature and sex from sternal lengths: an autopsy study", Anatomical Science International, Blackwell Publishing, GB, Vol. 90, No. 2, April 19, 2014, pages 89-96, 8 pp was disclosed by Applicant in the IDS dated 11/12/2025.