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 Arguments
Applicant’s arguments filed 5/18/2026 with respect to the objection to Claims 1-14 for minor informalities have been fully considered and are persuasive. The Examiner agrees that Applicant’s amendments have resolved the cited informalities. The objection to Claims 1-14 is withdrawn.
Applicant’s arguments regarding the interpretation of Claim 10 under 35 USC 112(f) have been fully considered and are persuasive to the extent that the term “means for recording a predetermined event” is no longer recited by the claim. Accordingly, the term “means for recording a predetermined event” is no longer being interpreted under 35 USC 112(f).
Applicant’s arguments regarding the rejection of Claim 5 under 35 USC 112(a) for failing to comply with the written description requirement based on its use of the term “NASA lead” have been fully considered and are persuasive. The term “NASA lead” is being interpreted in accordance with the meaning set forth by Applicant on Pg. 8-9 of Applicant’s 5/18/2026 Remarks.
Applicant’s arguments regarding the rejection of Claims 1, 2, 5, 7-10 and 12-14 and Claims 3-4 and 11 by dependency under 35 USC 112(b) have been fully considered and are persuasive. The Examiner agrees that Applicant’s amendments have resolved the previously cited indefiniteness issues. Therefore, the rejection is withdrawn.
Applicant’s arguments with respect to the rejection of Independent Claims 1 and 2 under 35 USC 103 as 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 have been fully considered and are persuasive to the extent that the Examiner agrees the combination of Grossman, Ganesan and Goksin does not teach “wherein the first measurement electrode is positioned within a circular region having a radius of 5 cm centered at a point located 7.5 cm to 15 cm downward from the geometric reference,” and “wherein the garment is configured such that, in a worn state in which the garment conforms to a torso of the wearer, the first measurement electrode corresponds to a position on the wearer corresponding to a fifth intercostal region” as recited by amended Claims 1 and 2. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of F. Marcus et al., "Clinical location of the fourth and fifth intercostal spaces as a percent of the length of the sternum," Journal of Electrocardiology, Volume 51, Issue 1, January–February 2018, Pages 55-59.
Applicant’s argument that “Grossman's figures and description are directed to labeled aperture locations and harnesses for conventional lead placement, not to define an electrode position based on a geometric reference derived from a neckline” (Remarks at Pg. 13) are not persuasive. Regardless of whether Grossman expressly defines electrode position in the same manner as claimed, Grossman’s positioning is broadly consistent with that of Claim 1. The specific mathematically defined positioning of Claim 1 is not alleged by the Examiner to be taught by Grossman: Goksin and Marcus are used for these specifics. Applicant’s arguments attack Grossman individually without regard for its place in the proposed combination, and are not persuasive.
Pertinent to this Argument, the Examiner disagrees that “Grossman does not teach or suggest ‘a neckline defined by an edge of a neck opening of the garment,’ much less that ‘a first measurement electrode or its measurement electrode mounting part is arranged at a position defined based on a geometric reference derived from the neckline.’ Grossman also does not teach or suggest that ‘the geometric reference is defined as a center point of a straight line connecting a leftmost point and a rightmost point of the neckline when worn.’” Grossman teaches these limitations at least at Grossman’s Fig. 6, as shown in Annotated Fig. 6 below. Applicant’s arguments appear to be based on the fact that Grossman does not use the same terminology as does Applicant. This is not persuasive, as Grossman’s garment fits the description of Claim 1, regardless of the terminology difference.
Applicant’s argument that “Grossman's general sizing for children, men, women, or breast size does not teach the claimed selection of a garment size based on "physique information of a wearer including at least a height H," nor does it teach selection in view of the claimed "distance D" or Formula [A]” (Remarks at Pg. 14) is not persuasive. The Examiner has never alleged Grossman to teach these limitations. The same is true of Applicant’s argument that Grossman does not teach “the garment is configured such that, in a worn state in which the garment conforms to a torso of the wearer, the first measurement electrode corresponds to a position on the wearer corresponding to a fifth intercostal region” (Remarks at Pg. 14). Applicant’s arguments attack Grossman individually without regard for its place in the proposed combination, and are not persuasive.
Applicant’s argument that “Ganesan provides no teaching that would remedy Grossman's failure to disclose the claimed neckline-derived geometric reference and the claimed electrode-positioning relationship” (Remarks at Pg. 15) are not persuasive. Ganesan is not cited for this teaching.
Applicant’s arguments regarding Goksin (Remarks at Pg. 15-16) have been fully considered but are not persuasive. Applicant’s position is that “Goksin is an autopsy study directed to estimating stature and sex from measured sternal lengths,” and does not teach several limitations because it makes no mention of ECG placement. Several limitations that Applicant argues Goksin not to disclose are not alleged to be disclosed by Goksin, and Applicant’s arguments regarding these limitations are not persuasive. Regardless, Applicant’s arguments appear to be analogous art arguments. The Examiner explains at Para. 35(a) of the Non-Final Office Action dated 1/16/2026 that Goksin is analogous art by MPEP 2141.01(a)’s “reasonably pertinent” standard. Applicant’s arguments are not persuasive.
The Examiner additionally notes that the Present Specification itself cites Goksin as relevant at Para. [0052], and uses Goksin for the precisely the same teaching as does the Examiner.
Applicant’s arguments regarding Independent Claim 2 are similar to Applicant’s arguments regarding Independent Claim 1. Applicant’s arguments have been fully considered and are persuasive/unpersuasive for the same reasons as Claim 1.
Applicant’s arguments regarding the rejection of Claims 4, 8-10 and 14 under 35 USC 103 are based on Applicant’s arguments regarding Independent Claim 1. Applicant’s arguments have been fully considered and are persuasive for the same reasons as Claim 1. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of F. Marcus et al., "Clinical location of the fourth and fifth intercostal spaces as a percent of the length of the sternum," Journal of Electrocardiology, Volume 51, Issue 1, January–February 2018, Pages 55-59.
Applicant’s arguments regarding the rejection of Claims 3, 5, 6-7, and 11-13 under 35 USC 103 are similar Applicant’s arguments regarding Independent Claim 1. Applicant’s arguments have been fully considered and are persuasive for the same reasons as Claim 1. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of F. Marcus et al., "Clinical location of the fourth and fifth intercostal spaces as a percent of the length of the sternum," Journal of Electrocardiology, Volume 51, Issue 1, January–February 2018, Pages 55-59.
With particular note to Applicant’s arguments with respect to Claim 13, the Examiner agrees with Applicant’s arguments regarding Boaz in principle, but disagrees that the Claim 13 is adequately distinguished from Boaz given the outstanding 112 issues, both with respect to Claim 13 itself and with Claim 1 from which Claim 13 depends.
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:
Claim 10, “an input device configured to receive an input for recording a predetermined even.” 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.
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, 2 and 10, and Claims 3-9 and 11-14 by dependency, 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.
Regarding Claim 1, Claim 1 recites “…wherein a first measurement electrode or its measurement electrode mounting part is arranged at a position defined based on a geometric reference derived from the neckline.” The Present Specification does not provide support for such a “position defined based on a geometric reference derived from the neckline.” The term “geometric reference” does not appear in the Present Specification. Applicant’s Remarks dated 5/18/2026 cite Paras. [0026], [0028]-[0030], [0035]-[0037], [0063] and Figs. 5-7, 9 and 10-12 as supporting the claim amendments among which the noted “position” is introduced. However, none of these contain the term “geometric reference,” and none support such a “position defined based on a geometric reference derived from the neckline” as recited by Claim 1. One of ordinary skill in the art would be unable to deduce from the Present Specification where exactly the “first measurement electrode” is required by Claim 1 to be positioned.
The Claim 1 limitation “wherein the first measurement electrode is positioned within a circular region having a radius of 5 cm centered at a point located 7.5 cm to 15 cm downward from the geometric reference” is not supported by the Present Specification for the same reasons.
For purposes of this Office Action, the Claim 1 limitation “…wherein a first measurement electrode or its measurement electrode mounting part is arranged at a position defined based on a geometric reference derived from the neckline” is being interpreted to mean that the first measurement electrode is positioned on the sternal manubrium, as is stated to be “preferable” at Para. [0036] of the Present Specification.
For purposes of this Office Action, the Claim 1 limitation “wherein the first measurement electrode is positioned within a circular region having a radius of 5 cm centered at a point located 7.5 cm to 15 cm downward from the geometric reference” is being interpreted to mean that the first measurement electrode “is positioned within a circular region having a radius of 5 cm centered at a point located 7.5 cm to 15 cm downward from” the sternum manubrium.
Regarding Independent Claim 2, Claim 2 recites “…wherein a first measurement electrode or its measurement electrode mounting part is arranged at a position defined based on a geometric reference derived from the neckline” and “wherein the first measurement electrode is positioned within a circular region having a radius of 5 cm centered at a point located 7.5 cm to 15 cm downward from the geometric reference” similarly to Claim 1. These limitations are not supported by the Present Specification for the same reasons as explained above with respect to Claim 1.
Regarding Claim 10, Claim 10 recites “an input device configured to receive an input for recording a predetermined even.” The term “input device…” is not used in the Present Specification, and it is not clear from the Present Specification which structure(s) correspond to the recited “input device.” The recited “input device…” constitutes new matter.
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, 10, 13, 13 and 14, and Claims 4-9 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:
Independent Claim 1 recites “A multi-lead electrocardiographic testing method having two or more leads….” It is unclear in what sense a method can have two or more leads.
For purposes of this Office Action, this limitation is being interpreted to mean that two or more leads are generally involved in the method.
Independent Claim 1 recites “using a plurality of garments having at least two or more different sizes.” It is grammatically unclear whether the entire plurality of garments has at least two or more different sizes, or whether individual garments of the plurality of garments have different sizes.
For purposes of this Office Action, this limitation is being interpreted in accordance with the latter.
Independent Claim 1 Claim 1 recites “and each of the plurality of garments comprising at least three measurement electrodes or measurement electrode attachment parts and a connector part configured to secure a measurement device.” It is grammatically unclear whether each garment comprises:
(a) at least three measurement electrodes, or (b) measurement electrode attachment parts and a connector part configured to secure a measurement device;
In accordance with its plain meaning, the Examiner is interpretating the above limitation in accordance with this first interpretation for purposes of this Office Action.
(a) at least three measurement electrodes, or (b) at least three measurement electrode attachment parts and a connector part configured to secure a measurement device;
(a) at least three measurement electrodes, or (b) at least three measurement electrode attachment parts, and (c) a connector part configured to secure a measurement device;
(a) at least three measurement electrodes, or (b) measurement electrode attachment parts, and (c) a connector part configured to secure a measurement device; or
Something else.
Independent Claim 1 recites “the garment.” It is unclear if the term “the garment” is intended to reference individual garments of the plurality of garments, the plurality of garments as a whole, or the selected garment of the plurality of garments. The term appears to reference each at different points throughout the claim.
Regarding Independent Claim 2, Independent Claim 2 contains limitations similar to each of those noted above with respect to Claim 1, and is indefinite for the same reasons.
Regarding Claim 3, Claim 3 recites “the clothes.” There is insufficient antecedent basis for this limitation.
Regarding Claim 10, Claim 10 recites “an input device configured to receive an input for recording a predetermined even,” which 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. The term “input device” is not used in the Present Specification, and it is not clear from the Present Specification which structure(s) correspond to the recited “input device.” 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.
For purposes of this Office Action, the term “input device…” is being interpreted to mean such a “means for recording” as was previously recited.
Applicant may:
(a) 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;
(b) 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
(c) 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:
(a) 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
(b) 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 12, Claim 12 recites “wherein, about a wiring for connecting the measurement electrode or the measurement electrode attachment part and the connector part has an electrical resistivity increase of 0% to 30% when the wiring is stretched by 20% relative to an original length of the wiring.”
It is grammatically unclear what is meant by “about a wiring for connecting….”
It is unclear in what sense the structure of “a wiring for connecting the measurement electrode or the measurement electrode attachment part and the connector part” limits the “multi-lead electrocardiographic testing method.” See MPEP 2173.05(p)(II).
Regarding Claim 13:
Claim 13 recites “the clothes.” There is insufficient antecedent basis for this limitation.
Claim 13 recites “wherein a fabric portion of the clothes located within a region extending 10 cm downward from the first measurement electrode or the measurement electrode attachment part and having a width of 5 cm has an extension rate of 160% or less when a load of 4.9 N is applied to the fabric portion in a vertical direction.” It is unclear in what sense the structure of “a fabric portion of the clothes” limits the “multi-lead electrocardiographic testing method.” See MPEP 2173.05(p)(II).
Regarding Claim 14, Claim 14 recites “the clothes.” There is insufficient antecedent basis for this limitation
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 previously cited US 20110004088 A1 to Grossman et al. (“Grossman”) in view of previously cited WO 2020/205853 A1 to Ganesan et al. (“Ganesan”), previously cited 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”) and F. Marcus et al., "Clinical location of the fourth and fifth intercostal spaces as a percent of the length of the sternum," Journal of Electrocardiology, Volume 51, Issue 1, January–February 2018, Pages 55-59 (“Marcus”) as evidenced by Dr Peter de Souza, "Manubrium of Sternum," Anatomy Zone, accessed online via https://anatomyzone.com/articles/manubrium-sternum/ on 7/8/2026, 13 December 2020 (“de Souza”).
Regarding Independent Claim 1, Grossman teaches:
A multi-lead electrocardiographic testing method having two or more leads (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 a plurality of garments having 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.”);
and each of the plurality of garments comprising at least three measurement electrodes or measurement electrode attachment parts and a connector part configured to secure a measurement device, (Fig. 6, see Annotated Fig. 6, below);
wherein each of the plurality of garments includes: a neckline defined by an edge of a neck opening of the garment, (Fig. 6, see Annotated Fig. 6, below);
wherein a first measurement electrode or its measurement electrode mounting part is arranged at a position defined based on a geometric reference derived from the neckline, (Fig. 6, see Annotated Fig. 6, below);
PNG
media_image1.png
778
827
media_image1.png
Greyscale
the method comprising: (1) obtaining physique information of a wearer … (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 Paras. [0020] and [0039] teach “obtaining physique information,” but Grossman does not teach obtaining such physique information “including at least a height H.” This deficiency is addressed below.
(2) selecting, from the plurality of garments, a garment size such that, when the garment is worn by the wearer, a positional relationship between the first measurement electrode and a predetermined anatomical reference of the wearer satisfies a predetermined condition; (Para. [0019], “Women with large breast size can be accommodated more easily and quickly with the ECG Shirt. The ECG Shirt creates a form of standardization that addresses the concern among clinical experts for the wide variation in the identification of the correct location for electrode placement, particularly in the lateral leads and in women. This has significant implications when comparing ECG in which electrodes have been placed by different clinicians;” 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 garment is selected as appropriately sized based on gender (Grossman at Para. [0020]), and such gender-based size selection results in a positional relationship between the first measurement electrode and a predetermined anatomical reference of the wearer satisfying the predetermined condition of “correct location for electrode placement” (Grossman at Para. [0020]).
wherein the geometric reference is defined as a center point of a straight line connecting a leftmost point and a rightmost point of the neckline when worn, (Fig. 6, see Annotated Fig. 6, above);
Grossman does not disclose:
(1) obtaining physique information of a wearer including at least a height H:
That is, Grossman’s Paras. [0020] and [0039] teach “obtaining physique information,” but Grossman does not teach obtaining such physique information “including at least a height H.”
(3) providing the selected garment and the measurement device to the wearer;
(4) causing the wearer to wear the selected garment and the measurement device;
and (5) starting electrocardiogram measurement,
wherein the first measurement electrode is positioned within a circular region having a radius of 5 cm centered at a point located 7.5 cm to 15 cm downward from the geometric reference,
wherein the garment is configured such that, in a worn state in which the garment conforms to a torso of the wearer, the first measurement electrode corresponds to a position on the wearer corresponding to a fifth intercostal region,
wherein a distance D is defined as a vertical distance, measured in a direction corresponding to a vertical direction of a torso of the wearer in a worn state of the garment, between (i) the first measurement electrode and (ii) a garment position that corresponds to a fifth intercostal region of the wearer, and wherein the height H and the distance D satisfy following Formula [Al: D = [(H - 119.390) / 2.471 ± 5.0 ---Formula [A].
Ganesan describes a “Physiological sensing textile apparatus” (Title). Ganesan is analogous art.
Ganesan teaches:
(1) obtaining physique information of a wearer including at least a height H, (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.”).
(3) providing the selected garment and the measurement device to the wearer; (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 provided Ganesan’s garment for testing. This “Performance Study” equates to the recited method steps.
(4) causing the wearer to wear the selected garment 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) starting 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.”);
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]).
The invention of Claim 1 differs from that of combined Grossman and Ganesan in that Grossman’s electrodes are positioned differently than those of Claim 1, at least in the sense that Grossman does not explicitly define its electrode positioning. This difference is reflected in the following limitations:
wherein the first measurement electrode is positioned within a circular region having a radius of 5 cm centered at a point located 7.5 cm to 15 cm downward from the geometric reference,
wherein the garment is configured such that, in a worn state in which the garment conforms to a torso of the wearer, the first measurement electrode corresponds to a position on the wearer corresponding to a fifth intercostal region
wherein a distance D is defined as a vertical distance, measured in a direction corresponding to a vertical direction of a torso of the wearer in a worn state of the garment, between (i) the first measurement electrode and (ii) a garment position that corresponds to a fifth intercostal region of the wearer, and wherein the height H and the distance D satisfy following Formula [A]: D = [(H - 119.390) / 2.471 ± 5.0 ---Formula [A].
The electrode placement of Claim 1 which Grossman lacks is a common electrode placement scheme that is known in the art, as explained in light of the references applied below.
Marcus pertains to “verify[ing] accurate placement of the precordial ECG leads by identifying the 4th and 5th intercostal spaces as a function of the length of the sternum” (Abstract). Marcus is analogous art.
Marcus teaches:
wherein the first measurement electrode is positioned within a circular region having a radius of 5 cm centered at a point located 7.5 cm to 15 cm downward from the geometric reference, (Pg. 55, Left Column, First Paragraph, “The standardization of precordial leads was published in 1938 and has been consistently observed since then [1].Leads V1 and V2 are placed in the 4th intercostal space to the right and left of the sternum respectively and V4-V6 are located in the 5th intercostal space;” Pg. 56, Table 2, see Marcus Annotated Table 2, below);
PNG
media_image2.png
441
591
media_image2.png
Greyscale
Marcus’s Table 2 depicts “total sternal length” (i.e., the distance from the sternal notch to the xiphoid process) and “bottom to top distance” of the fifth intercostal space (i.e., distance from the sternal notch to the fifth intercostal space).
Claim 1’s “circular region having a radius of 5 cm centered at a point located 7.5 cm to 15 cm downward from the geometric reference” corresponds to a total vertical distance ranging from 2.5 cm to 20 cm (i.e., radius of 5 cm plus “downward” distance of 7.5 cm to 15 cm is equal to a total vertical distance ranging from 2.5 cm to 20 cm).
As explained above, the Claim 1 limitation “…wherein a first measurement electrode or its measurement electrode mounting part is arranged at a position defined based on a geometric reference derived from the neckline” is being interpreted to mean that the first measurement electrode is positioned on the sternal manubrium, as is stated to be “preferable” at Para. [0036] of the Present Specification. As further explained above, the Claim 1 limitation “wherein the first measurement electrode is positioned within a circular region having a radius of 5 cm centered at a point located 7.5 cm to 15 cm downward from the geometric reference” is being interpreted to mean that the first measurement electrode “is positioned within a circular region having a radius of 5 cm centered at a point located 7.5 cm to 15 cm downward from” the sternum manubrium.
The sternal notch is positioned at the top of the sternal manubrium. See de Souza at Pg. 1, Ln. 6-8.
Marcus’s “bottom to top distance” of the fifth intercostal space measures the same anatomical space as that of Claim 1’s “circular region having a radius of 5 cm centered at a point located 7.5 cm to 15 cm downward from the geometric reference”
Marcus’s “Table 2” discloses a range of “bottom to top distance” of the fifth intercostal space of 13.8 cm to 18 cm. Marcus’s range of 13.8 cm to 18 cm lies inside the claimed range of “7.5 cm to 15 cm,” as the claimed range is explained to be interpreted above. “In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists.” MPEP 2144.05(I). Although Marcus does not disclose the precise range of “7.5 cm to 15 cm” as recited by Claim 1, it would have been obvious for a person of ordinary skill in the art to select from Marcus’s range of “13.8 cm to 18 cm” any distance, including “7.5 cm to 15 cm” as so-doing would be likely to result in success.
The specification discloses the appropriate ranges that apply to the claimed invention at Paras. [0019] and [0045]. However, the specification does not disclose that the specifically claimed range of “7.5 cm to 15 cm” is for any particular purpose or to solve any stated problem that distinguishes it from the other ranges disclosed. The specification therefore lacks disclosure of the criticality required by the Courts in providing patentability to the claimed range.
wherein the garment is configured such that, in a worn state in which the garment conforms to a torso of the wearer, the first measurement electrode corresponds to a position on the wearer corresponding to a fifth intercostal region, (Pg. 55, Left Column, First Paragraph, “The standardization of precordial leads was published in 1938 and has been consistently observed since then [1].Leads V1 and V2 are placed in the 4th intercostal space to the right and left of the sternum respectively and V4-V6 are located in the 5th intercostal space.”);
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 Marcus (i.e., to position Grossman’s first measurement electrode in the manner of Marcus) in order to ensure placement consistent with well established standards, thereby reducing misdiagnoses in the ECG reading (Marcus at Abstract; Pg. 55, Left Column, First Paragraph).
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.
The Examiner notes that the Present Specification itself cites Goskin as relevant at Para. [0052].
Goskin teaches:
wherein a distance D is defined as a vertical distance, measured in a direction corresponding to a vertical direction of a torso of the wearer in a worn state of the garment, between (i) the first measurement electrode and (ii) a garment position that corresponds to a fifth intercostal region of the wearer, and wherein the height H and the distance D satisfy following Formula [A]: D = [(H - 119.390) / 2.471 ± 5.0 ---Formula [A]. (Pg. 93, Table 2; see Annotated Table 2, below).
Goksin’s “X4: total sternal length” is equal to “D” as defined by the formula of Claim 1 when mathematically rearranged to isolate “X4.”
PNG
media_image3.png
306
707
media_image3.png
Greyscale
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.
The specification discloses the appropriate ranges that apply to the claimed invention at Paras. [0023] and [0051]. However, the specification does not disclose that the specifically claimed range is for any particular purpose or to solve any stated problem that distinguishes it from the other ranges disclosed. The specification therefore lacks disclosure of the criticality required by the Courts in providing patentability to the claimed range.
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, Ganesan and Marcus with the teachings of Goksin (i.e., to relate the distance on garment from “the first measurement electrode” to a point on the clothes which lies (during use) at “the fifth intercostal assumed height” and thus 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:
A multi-lead electrocardiographic testing method having two or more leads(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 a plurality of garments having 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.”);
and each of the plurality of garments comprising at least three measurement electrodes or measurement electrode attachment parts and a connector part configured to secure a measurement device, (Fig. 6, see Annotated Fig. 6, above at Claim 1);
wherein each of the plurality of garments includes: a neckline defined by an edge of a neck opening of the garment, (Fig. 6, see Annotated Fig. 6, above at Claim 1);
wherein a first measurement electrode or its measurement electrode mounting part is arranged at a position defined based on a geometric reference derived from the neckline, (Fig. 6, see Annotated Fig. 6, above at Claim 1);
the method comprising: (1) obtaining physique information of a wearer…(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 Paras. [0020] and [0039] teach “obtaining physique information,” but Grossman does not teach obtaining such physique information “including at least a height H.” This deficiency is addressed below.
(2) selecting, from the plurality of garments, a garment size such that, when the garment is worn by the wearer, a positional relationship between the first measurement electrode and a predetermined anatomical reference of the wearer satisfies a predetermined condition; (Para. [0019], “Women with large breast size can be accommodated more easily and quickly with the ECG Shirt. The ECG Shirt creates a form of standardization that addresses the concern among clinical experts for the wide variation in the identification of the correct location for electrode placement, particularly in the lateral leads and in women. This has significant implications when comparing ECG in which electrodes have been placed by different clinicians;” 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 garment is selected as appropriately sized based on gender (Grossman at Para. [0020]), and such gender-based size selection results in a positional relationship between the first measurement electrode and a predetermined anatomical reference of the wearer satisfying the predetermined condition of “correct location for electrode placement” (Grossman at Para. [0020]).
wherein the geometric reference is defined as a center point of a straight line connecting a leftmost point and a rightmost point of the neckline when worn, (Fig. 6, see Annotated Fig. 6, above at Claim 1);
Grossman does not disclose:
(1) obtaining physique information of a wearer including at least a height H:
That is, Grossman’s Paras. [0020] and [0039] teach “obtaining physique information,” but Grossman does not teach obtaining such physique information “including at least a height H.”
(3) providing the selected garment and the measurement device to the wearer;
(4) causing the wearer to wear the selected garment and the measurement device;
and (5) starting electrocardiogram measurement,
wherein the first measurement electrode is positioned within a circular region having a radius of 5 cm centered at a point located 7.5 cm to 15 cm downward from the geometric reference,
wherein the garment is configured such that, in a worn state in which the garment conforms to a torso of the wearer, the first measurement electrode corresponds to a position on the wearer corresponding to a fifth intercostal region,
wherein a distance D is defined as a vertical distance, measured in a direction corresponding to a vertical direction of a torso of the wearer in a worn state of the garment, between (i) the first measurement electrode and (ii) a garment position that corresponds to a fifth intercostal region of the wearer, and wherein the height H and the distance D satisfy following Formula [B] in case the wear is a male: D = [(H - 126.388) / 2.231 ± 5.0 [B] --- Formula [B], or wherein the height H and the distance D satisfy following Formula [Ci in case the wear is a female: D = [(H - 110.713) / 2.761 ± 5.0 ---Formula [C].
Ganesan describes a “Physiological sensing textile apparatus” (Title). Ganesan is analogous art.
Ganesan teaches:
(1) obtaining physique information of a wearer including at least a height H, (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.”).
(3) providing the selected garment and the measurement device to the wearer; (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 provided Ganesan’s garment for testing. This “Performance Study” equates to the recited method steps.
(4) causing the wearer to wear the selected garment 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) starting 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.”);
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]).
The invention of Claim 1 differs from that of combined Grossman and Ganesan in that Grossman’s electrodes are positioned differently than those of Claim 1, at least in the sense that Grossman does not explicitly define its electrode positioning. This difference is reflected in the following limitations:
wherein the first measurement electrode is positioned within a circular region having a radius of 5 cm centered at a point located 7.5 cm to 15 cm downward from the geometric reference,
wherein the garment is configured such that, in a worn state in which the garment conforms to a torso of the wearer, the first measurement electrode corresponds to a position on the wearer corresponding to a fifth intercostal region,
wherein a distance D is defined as a vertical distance, measured in a direction corresponding to a vertical direction of a torso of the wearer in a worn state of the garment, between (i) the first measurement electrode and (ii) a garment position that corresponds to a fifth intercostal region of the wearer, and wherein the height H and the distance D satisfy following Formula [B] in case the wear is a male: D = [(H - 126.388) / 2.231 ± 5.0 [B] --- Formula [B], or wherein the height H and the distance D satisfy following Formula [Ci in case the wear is a female: D = [(H - 110.713) / 2.761 ± 5.0 ---Formula [C].
The electrode placement of Claim 1 which Grossman lacks is a common electrode placement scheme that is known in the art, as explained in light of the references applied below.
Marcus pertains to “verify[ing] accurate placement of the precordial ECG leads by identifying the 4th and 5th intercostal spaces as a function of the length of the sternum” (Abstract). Marcus is analogous art.
Marcus teaches:
wherein the first measurement electrode is positioned within a circular region having a radius of 5 cm centered at a point located 7.5 cm to 15 cm downward from the geometric reference, (Pg. 55, Left Column, First Paragraph, “The standardization of precordial leads was published in 1938 and has been consistently observed since then [1].Leads V1 and V2 are placed in the 4th intercostal space to the right and left of the sternum respectively and V4-V6 are located in the 5th intercostal space;” Pg. 56, Table 2, see Marcus Annotated Table 2, above at Claim 1);
This limitation is being interpreted similarly to the similar Claim 1 limitation, and the explanation above at Claim 1 applies similarly.
wherein the garment is configured such that, in a worn state in which the garment conforms to a torso of the wearer, the first measurement electrode corresponds to a position on the wearer corresponding to a fifth intercostal region, (Pg. 55, Left Column, First Paragraph, “The standardization of precordial leads was published in 1938 and has been consistently observed since then [1].Leads V1 and V2 are placed in the 4th intercostal space to the right and left of the sternum respectively and V4-V6 are located in the 5th intercostal space.”);
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 Marcus (i.e., to position Grossman’s first measurement electrode in the manner of Marcus) in order to ensure placement consistent with well established standards, thereby reducing misdiagnoses in the ECG reading (Marcus at Abstract; Pg. 55, Left Column, First Paragraph).
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.
The Examiner notes that the Present Specification itself cites Goskin as relevant at Para. [0052].
Goskin teaches:
wherein a distance D is defined as a vertical distance, measured in a direction corresponding to a vertical direction of a torso of the wearer in a worn state of the garment, between (i) the first measurement electrode and (ii) a garment position that corresponds to a fifth intercostal region of the wearer, and wherein the height H and the distance D satisfy following Formula [B] in case the wear is a male: D = [(H - 126.388) / 2.231 ± 5.0 [B] --- Formula [B], or wherein the height H and the distance D satisfy following Formula [Ci in case the wear is a female: D = [(H - 110.713) / 2.761 ± 5.0 ---Formula [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 garment 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, Marcus 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 (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, Marcus and Goksin renders obvious the entirety of Claim 1 as explained above.
Ganesan additionally teaches:
wherein data obtained by the electrocardiogram measurement is transmitted and recorded on a server directly from the measurement device or via the terminal wirelessly communicates with the measurement device (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, Marcus and Goksin renders obvious the entirety of Claim 1 as explained above.
Ganesan additionally teaches:
wherein data obtained by the electrocardiographic measurement is stored on a recording medium within a device (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, Marcus 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 an input device configured to receive an input for recording a predetermined event (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, Marcus and Goksin renders obvious the entirety of Claim 1 as explained above.
Grossman additionally teaches:
wherein the clothes include a detachable portion to which the measurement electrode or the measurement electrode attachment part is attached, and the detachable portion is detachable, in whole or in part, from a remaining portion of the clothes. (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 previously cited US 20110004088 A1 to Grossman et al. (“Grossman”) in view of previously cited WO 2020/205853 A1 to Ganesan et al. (“Ganesan”), previously cited 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”) and F. Marcus et al., "Clinical location of the fourth and fifth intercostal spaces as a percent of the length of the sternum," Journal of Electrocardiology, Volume 51, Issue 1, January–February 2018, Pages 55-59 (“Marcus”) as evidenced by Dr Peter de Souza, "Manubrium of Sternum," Anatomy Zone, accessed online via https://anatomyzone.com/articles/manubrium-sternum/ on 7/8/2026, 13 December 2020 (“de Souza”) as applied to Claim 1 above, and further in view of previously cited US 2018/0000415 A1 to Gupta et al. (“Gupta”)
Regarding Claim 3, the combination of Grossman, Ganesan, Marcus 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. (Para. [0139], “User studies were conducted to evaluate and validate the performance of the garment system 10”).
The combination of Grossman, Ganesan, Marcus and Goksin does not disclose
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:
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, Marcus 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, Marcus 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 previously cited US 20110004088 A1 to Grossman et al. (“Grossman”) in view of previously cited WO 2020/205853 A1 to Ganesan et al. (“Ganesan”), previously cited 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”) and F. Marcus et al., "Clinical location of the fourth and fifth intercostal spaces as a percent of the length of the sternum," Journal of Electrocardiology, Volume 51, Issue 1, January–February 2018, Pages 55-59 (“Marcus”) as evidenced by Dr Peter de Souza, "Manubrium of Sternum," Anatomy Zone, accessed online via https://anatomyzone.com/articles/manubrium-sternum/ on 7/8/2026, 13 December 2020 (“de Souza”) as applied to Claim 1 above, and further in view of previously cited 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 previously cited 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, Marcus and Goksin renders obvious the entirety of Claim 1 as explained above
The combination of Grossman, Ganesan, Marcus and Goksin does not disclose:
the electrocardiographic measurement uses three lead configurations including a NASA lead, a CM5 lead, and a CC5 lead.
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 electrocardiographic measurement uses three lead configurations including a NASA lead… (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, Marcus 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, Marcus 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 electrocardiographic measurement uses three lead configurations including … a CM5 lead, and a CC5 lead (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, Marcus, 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, Marcus 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 previously cited US 20110004088 A1 to Grossman et al. (“Grossman”) in view of previously cited WO 2020/205853 A1 to Ganesan et al. (“Ganesan”), previously cited 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”) and F. Marcus et al., "Clinical location of the fourth and fifth intercostal spaces as a percent of the length of the sternum," Journal of Electrocardiology, Volume 51, Issue 1, January–February 2018, Pages 55-59 (“Marcus”) as evidenced by Dr Peter de Souza, "Manubrium of Sternum," Anatomy Zone, accessed online via https://anatomyzone.com/articles/manubrium-sternum/ on 7/8/2026, 13 December 2020 (“de Souza”) as applied to Claim 1 above, and further in view of previously cited US 20110288605 A1 to Kaib et al. (“Kaib”).
Regarding Claim 6, the combination of Grossman, Ganesan, Marcus and Goksin renders obvious the entirety of Claim 1 as explained above.
The combination of Grossman, Ganesan, Marcus and Goksin does not disclose:
wherein, the step (5) further includes determining whether the selected garment and the measurement device are properly worn; and informing the wearer of a result of the determination
Kaib describes a “WEARABLE AMBULATORY MEDICAL DEVICE WITH MULTIPLE SENSING ELECTRODES” (Title). Kaib is analogous art.
Kaib teaches:
wherein, the step (5) further includes determining whether the selected garment and the measurement device are properly worn; and informing the wearer of a result of the determination (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, Marcus and Goksin with the teachings of Kaib (i.e., to further include in the method of combined Grossman, Ganesan, Marcus and Goksin a step of determining and informing the patient whether the clothes and the measurement device are properly worn 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, Marcus, Goksin and Kaib renders obvious the entirety of Claim 6 as explained above.
Kaib additionally teaches:
the informing step further comprising informing the wearer by at least one of a vibration, a light, and a sound generated from the measurement device or a terminal wirelessly communicating with the measurement device (Para. [0007]).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over previously cited US 20110004088 A1 to Grossman et al. (“Grossman”) in view of previously cited WO 2020/205853 A1 to Ganesan et al. (“Ganesan”), previously cited 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”) and F. Marcus et al., "Clinical location of the fourth and fifth intercostal spaces as a percent of the length of the sternum," Journal of Electrocardiology, Volume 51, Issue 1, January–February 2018, Pages 55-59 (“Marcus”) as evidenced by Dr Peter de Souza, "Manubrium of Sternum," Anatomy Zone, accessed online via https://anatomyzone.com/articles/manubrium-sternum/ on 7/8/2026, 13 December 2020 (“de Souza”) as applied to Claim 1 above, and further in view of previously cited US 2008/0027341 A1 to Sackner et al. (“Sackner”).
Regarding Claim 11, the combination of Grossman, Ganesan, Marcus and Goksin renders obvious the entirety of Claim 1 as explained above.
The combination of Grossman, Ganesan, Marcus 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.
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, Marcus and Goksin with the teachings of Sackner (i.e., to include in the method of Grossman, Ganesan, Marcus 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 previously cited US 20110004088 A1 to Grossman et al. (“Grossman”) in view of previously cited WO 2020/205853 A1 to Ganesan et al. (“Ganesan”), previously cited 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”) and F. Marcus et al., "Clinical location of the fourth and fifth intercostal spaces as a percent of the length of the sternum," Journal of Electrocardiology, Volume 51, Issue 1, January–February 2018, Pages 55-59 (“Marcus”) as evidenced by Dr Peter de Souza, "Manubrium of Sternum," Anatomy Zone, accessed online via https://anatomyzone.com/articles/manubrium-sternum/ on 7/8/2026, 13 December 2020 (“de Souza”) 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, Marcus and Goksin renders obvious the entirety of Claim 1 as explained above.
The combination of Grossman, Ganesan, Marcus and Goksin does not disclose:
wherein, about a wiring for connecting the measurement electrode or the measurement electrode attachment part and the connector part has an electrical resistivity increase of 0% to 30% when the wiring is stretched by 20% relative to an original length of the wiring.
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 has an electrical resistivity increase of 0% to 30% when the wiring is stretched by 20% relative to an original length of the wiring. (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, Marcus 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, Marcus 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, Marcus and Goksin renders obvious the entirety of Claim 1 as explained above.
The combination of Grossman, Ganesan. Marcus and Goksin does not disclose:
wherein a fabric portion of the clothes located within a region extending 10 cm downward from the first measurement electrode or the measurement electrode attachment part and having a width of 5 cm has an extension rate of 160% or less when a load of 4.9 N is applied to the fabric portion in a vertical direction.
Boaz is analogous art as explained above.
Boaz teaches:
wherein a fabric portion of the clothes located within a region extending 10 cm downward from the first measurement electrode or the measurement electrode attachment part and having a width of 5 cm has an extension rate of 160% or less when a load of 4.9 N is applied to the fabric portion in a vertical direction.. (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, Marcus 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]).
Art Made of Record Although Not Relied Upon
The Examiner notes the relevance of P. Kligfield et al., "Recommendations for the Standardization and Interpretation of the Electrocardiogram: Part I," Circulation, Volume 115, Issue 10, 13 March 2007; Pages 1306-1324, which describes a similar electrode arrangement to that of Claims 1 and 2 at Pg. 1312, Right Column, First Paragraph.
The Examiner notes also the relevance of US 2016/0066809 A1, which describes an “Elastic Garment For Positioning And Fixing ECG Electrodes” (Title) and describes a similar electrode positioning at Para. [0004].
The Examiner further notes the relevance of US 2012/0136231 A1, which describes “A garment and/or garment system with health-monitoring (e.g., cardiovascular monitoring) capability…” (Abstract), and describes a similar electrode positioning at Para. [0042].
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 CHRISTOPHER J MUTCHLER whose telephone number is (571)272-8012. The examiner can normally be reached M-F 7:00 am - 4:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached at 571-270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/C.J.M./Examiner, Art Unit 3796
/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796
Prosecution Insights