DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first
inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/13/2026 has been entered.
Status of Claims
Claims 1 and 3-7 are amended.
Claims 14-16 are cancelled.
Claims 17-20 are added as new claims
Response to Arguments
Applicant’s arguments, see pages 6-10, filed 2/13/2026, with respect to the rejection(s) of
claim(s) 1-6 and 8-13 under 35 U.S.C. 103 rejection have been fully considered and are not persuasive. Therefore, the rejection has been maintained.
35 U.S.C. 103:
Regarding claim 1, applicant argues that Roham, alone or in combination with the prior art, does
not teach “wherein the first pressing part and the second pressing part cover the plurality of sensor electrodes, and wherein the at least one adapter is formed of a rigid material and has a predetermined height.” The applicant has amended claim 1 to state that both pressing parts of the adapter from Allen, alone, does not cover the plurality of electrodes. One cannot show non-obviousness by attacking the references individually where, as here, the rejection is based on a combination of references. In re Keller, 642 F .2d 413, 208 USPQ 871 (CCPA 1981). In this case, the adapter from Allen is used in combination with the electrode patch from Szabados to protect and cover the electrodes shown in figures 1A-B.
After further search and consideration, the examiner will still rely on Allen to teach “wherein the at least one adapter is formed of a rigid material and has a predetermined height” (fig. 5; col. 5, lines 1-17). It is disclosed that the carrier/adapter 14 can be made of a material and have a configuration that permits it to be sufficiently flexed to install it over the housing cover 16, e.g., plastic, silicone, rubber, metal, etc. Furthermore, the applicant’s specification discloses [62] that “the adapter body 410 may be formed of a hard material such as a plastic injection molding,” which although is rigid, is also more flexible than the metal material disclosed in Allen. Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sensor system of Szabados to add the carrier/adapter from Allen for the benefit of mitigating accidental or unintentional disassembly of the sensor system.
Regarding claim 3, applicant argues that the adapter from Allen, alone or in combination with
the prior art, does not teach “wherein the at least one adapter further comprises a single connection part connecting the first pressing part to the second pressing part, and wherein a housing groove into which the housing is inserted is defined between the first pressing part and the second pressing part.” After further search and consideration, the examiner will still rely on Allen to teach this limitation because no added structure was disclosed to define the singular connection part and is stated broadly. Therefore, the connection part is interpreted as shown below (fig. 5; col. 4, lines 17-68). It is disclosed that the carrier/adapter 14 has an opening 32, which receives a housing cover 16. The opening 32 equates to the groove into which the housing is inserted as shown below in the second annotated figure. The singular connection part is the box containing top and bottom sides of the adapter surrounding the groove.
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify sensor system of Szabados to add the connector from Allen for the benefit of mitigating accidental or unintentional disassembly of the sensor system when applying pressure between the two pressing parts.
Regarding claim 6, applicant argues that Allen, alone or in combination with the prior art, does
not teach “wherein a shape of an upper end of the first pressing part and the second pressing part is in a straight line.”
The examiner argues that although Allen, in combination with the prior art, does not explicitly teach the shape of the upper end of the first pressing part and the second pressing part to be a straight line, it would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the system as taught by Allen with the straight line, because Applicant has not disclosed that the straight line shape of the pressing parts provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with the curved line shape as taught by Allen because it provides a shape that would easily conform to the curvature of the human body when adhering the medical device to the patient’s skin and since it appears to be an arbitrary design consideration which fails to patentably distinguish over Allen.
Therefore, it would have been an obvious matter of design choice to modify Allen to obtain the invention as specified in the claim(s).
Applicant’s arguments, see pages 10-17, filed 2/13/2026, with respect to the 35 U.S.C. 103
rejection have been fully considered and are persuasive. The 35 U.S.C. 103 rejection of claim 7 has been withdrawn.
Regarding claim 7, applicant argues that Allen, alone or in combination with the prior art, does
not teach the amended claim “wherein the first pressing part and the second pressing part are connected solely by the single connection part along a first longitudinal peripheral edge of the at least one adapter, and wherein the first pressing part, the single connection part, and the second pressing part together define the housing groove.” After further search and consideration, the examiner found no art to teach this specific structure of the connection part of the adapter. Therefore, the 35 U.S.C. 103 rejection of claim 7 has been withdrawn.
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, 3, 6-7, 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Szabados
et al. US Pat.: US 11083371 B1, hereinafter Szabados in view of Allen, Sr et al. US Pat.: US 9183738 B1A1, hereinafter Allen.
Regarding claim 1, Szabados teaches a bio-signal measuring device comprising: a housing
accommodating a battery (fig. 1A-B; col 12-13, lines 65-67 and 1-59); Rigid housing 115 also typically contains a power source, such as one or more batteries.
a flexible substrate extending in a band shape, disposed on one side of the housing and electrically connected thereto, the flexible substrate including a plurality of sensor electrodes (fig. 1A-B; col 12-13, lines 65-67 and 1-16); Flexible body 110 (which may be referred to as “flexible substrate” or “flexible construct”) typically includes two wings 130, 131, which extend laterally from rigid housing 115, and two flexible electrode traces 311, 312, each of which is embedded in one of wings 130, 131.
wherein the housing and the plurality of sensor electrodes are disposed along a longitudinal direction of the flexible substrate (fig. 1A-B; col 12-13, lines 65-67 and 1-16). The two wings are disposed longitudinally across the flexible band shaped substrate.
However, Szabados does not teach at least one adapter formed to correspond to the housing and the flexible substrate, the adapter configured to press the flexible substrate; wherein the at least one adapter comprises a first pressing part disposed on the one side of the housing, and a second pressing part disposed on another side of the housing, wherein the housing is positioned between the first pressing part and the second pressing part; wherein the first pressing part and the second pressing part cover the plurality of sensor electrodes, and wherein the at least one adapter is formed of a rigid material and has a predetermined height..
Allen, in the same field of endeavor, teaches at least one adapter formed to correspond to the housing and the flexible substrate, the adapter configured to press the flexible substrate; wherein the at least one adapter comprises a first pressing part disposed on the one side of the housing, and a second pressing part disposed on another side of the housing, wherein the housing is positioned between the first pressing part and the second pressing part; wherein the first pressing part and the second pressing part cover the plurality of sensor electrodes, and wherein the at least one adapter is formed of a rigid material and has a predetermined height. (fig. 5; col. 4, lines 17-68; col. 5, lines 1-17). It is disclosed that the carrier 14 has an opening 32, which receives a housing cover 16. The first and second pressing part is shown below in the annotated figure. The carrier 14 acts as an adapter that surrounds the housing with two opposite sided pressing parts. It is disclosed that the carrier/adapter 14 can be made of a material and have a configuration that permits it to be sufficiently flexed to install it over the housing cover 16, e.g., plastic, silicone, rubber, metal, etc. Furthermore, the applicant’s specification discloses [62] that “the adapter body 410 may be formed of a hard material such as a plastic injection molding,” which although is rigid, is also more flexible than the metal material disclosed in Allen.
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sensor system of Szabados to add the carrier/adapter from Allen for the benefit of mitigating accidental or unintentional disassembly of the sensor system.
Regarding claim 3, Szabados in view of Allen teaches the claimed invention as modified and
Allen further teaches wherein the at least one adapter further comprises a single connection part connecting the first pressing part to the second pressing part, and wherein a housing groove into which the housing is inserted is defined between the first pressing part and the second pressing part (fig. 5; col. 4, lines 17-68). It is disclosed that the carrier/adapter 14 has an opening 32, which receives a housing cover 16. The opening 32 equates to the groove into which the housing is inserted as shown below in the second annotated figure. The singular connection part is the box containing top and bottom sides of the adapter surrounding the groove.
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify sensor system of Szabados to add the connector from Allen for the benefit of mitigating accidental or unintentional disassembly of the sensor system when applying pressure between the two pressing parts.
Regarding claim 6, Szabados in view of Allen teaches the claimed invention as modified and
Allen further teaches wherein a shape of an upper end of the first pressing part and the second pressing part is in a curved line (fig. 5; col. 4, lines 17-68). It is disclosed that the carrier 14 has an opening 32, which receives a housing cover 16. The shape of both pressing parts is in a curved line as shown in the annotated figures above.
Allen does not explicitly teach the shape of the upper end of the first pressing part and the second pressing part to be a straight line, it would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the system as taught by Allen with the straight line, because Applicant has not disclosed that the straight line shape of the pressing parts provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with the curved line shape as taught by Allen because it provides a shape that would easily conform to the curvature of the human body when adhering the medical device to the patient’s skin and since it appears to be an arbitrary design consideration which fails to patentably distinguish over Allen.
Therefore, it would have been an obvious matter of design choice to modify Allen to obtain the invention as specified in the claim(s).
Regarding claim 8, Szabados in view of Allen teaches the claimed invention as modified and
Szabados further teaches further comprising an elastic band including an elastic material to press the flexible substrate, the at least one adapter or both (fig. 1A-B; col 12-13, lines 65-67 and 1-16); Flexible body 110 (which may be referred to as “flexible substrate” or “flexible construct”) typically includes two wings 130, 131, which extend laterally from rigid housing 115, and two flexible electrode traces 311, 312, each of which is embedded in one of wings 130, 131.
Regarding claim 17, Szabados in view of Allen teaches the claimed invention as modified and
Allen further teaches wherein a length of the second pressing part is greater than a length of the first pressing part (fig. 5; col. 4, lines 17-68; col. 5, lines 1-17).
Allen does not explicitly teach length of the second pressing part is greater than a length of the first pressing part. It would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the system as taught by Allen with the second pressing part having a greater length, because Applicant has not disclosed that the greater length of the pressing part provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with pressing parts of equal length as taught by Allen because it provides a secure and effective closure when adhering the medical device to the patient’s skin and since it appears to be an arbitrary design consideration which fails to patentably distinguish over Allen.
Therefore, it would have been an obvious matter of design choice to modify Allen to obtain the invention as specified in the claim(s).
Regarding claim 18, Szabados in view of Allen teaches the claimed invention as modified and
Allen further teaches wherein the at least one adapter has a higher rigidity than the flexible substrate (fig. 5; col. 4, lines 17-68; col. 5, lines 1-17). It is disclosed that the carrier/adapter 14 can be made of a material and have a configuration that permits it to be sufficiently flexed to install it over the housing cover 16, e.g., plastic, silicone, rubber, metal, etc.
Regarding claim 19, Szabados in view of Allen teaches the claimed invention as modified and
Szabados further teaches further comprising a sub-patch (330) formed of a flexible adhesive material (340), the sub-patch (330) comprising: a patch body (110) having a shape corresponding to the flexible substrate (300); and a patch hole (370) defined through the patch body (110), the patch hole (370) configured to receive the housing therethrough, wherein the patch body (110) has a first length greater than a second length of the flexible substrate, a first width greater than a second width of the flexible substrate (300), and a first thickness greater than a second thickness of the flexible substrate (300), and wherein the sub-patch covers an entirety of an upper surface of the flexible substrate (300) (figs. 3A-B; col. 14, lines 3-67; col. 15, lines 1-20).
Regarding claim 20, Szabados in view of Allen teaches the claimed invention as modified and
Szabados further teaches wherein: the flexible substrate (300) includes a first adhesive layer (340) disposed on a surface configured to be attached to a wearer's body; the sub-patch (330) includes a second adhesive layer (340) configured to adhere to both the upper surface of the flexible substrate (300) and the wearer's body; and the at least one adapter (14; Allen) includes a third adhesive layer disposed on a concaved surface thereof and configured to be attached to an upper surface of the sub-patch (330) (figs. 3A-B; col. 14, lines 3-67; col. 15, lines 1-20). The top and bottom substrate layers must have some sort of adhesion material or layer to combine together as shown in figure 3A. Therefore, a second and third adhesive layer is disclosed to attach the different layers of the flexible substrate.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Szabados in view of Allen
in view of Hsu et al. US Pub.: US 20130150698 A1, hereinafter Hsu.
Regarding claim 2, Szabados in view of Allen teaches the housing is disposed between the
plurality of sensor electrodes.
However, Szabados in view of Allen does not teach the housing at a position spaced apart from a center of the flexible substrate.
Hsu, in the same field of endeavor, teaches the housing at a position spaced apart from a center of the flexible substrate (fig. 6B). It is explicitly shown that a housing 111 is position slightly off-center.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the housing of Szabados in view of Allen with the position of the housing from Hsu for the predictable result of increasing comfortability of the user while wearing the patch on the left or right side of the patient’s chest.
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Szabados in view of
Allen in view of Kumar et al. US Pub.: US 20110279963 A1, hereinafter Kumar
Regarding claim 4, Szabados in view of Allen does not teach wherein a thickness of the housing
groove facing each inner end of the first pressing part and the second pressing part corresponds to a thickness of the housing.
Kumar, in the same field of endeavor, teaches an enclosure (102) that corresponds to a thickness of the middle electronic component (fig. 1A-E; paragraph 64-67). The varying thickness of the housing 102 acts as an adapter for the electronic device. The figures show how the thickness increases at the middle of the device, but decreases at the outer parts of the device.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the adapter of Szabados in view of Allen with the varying thickness of Kumar for the benefit of providing substantial adhesion to the varying curvatures of the human body under different movements and conditions.
Regarding claim 5, Szabados in view of Allen does not teach wherein a thickness of each outer
end of the first pressing part and the second pressing part gradually decrease relative to a thickness of each inner end of the first pressing part and the second pressing part.
Kumar, in the same field of endeavor, teaches an enclosure (102) that corresponds to an increasing thickness towards the middle electronic component and decreases in thickness towards the ends of the enclosure (fig. 1A-E; paragraph 64-67). The varying thickness of the housing 102 acts as an adapter for the electronic device. The figures show how the thickness increases at the middle of the device, but decreases at the outer parts of the device.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the adapter of Szabados in view of Allen with the varying thickness of Kumar for the benefit of providing substantial adhesion to the varying curvatures of the human body under different movements and conditions.
Claims 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Szabados in view of
Allen in view of Hsu in view of Boyden et al. US Pub.: US 20090281413 A1, hereinafter Boyden.
Regarding claim 8, Szabados in view of Allen in view of Hsu does not explicitly teach further
comprising an elastic band including an elastic material to press the flexible substrate, the at least one adapter or both.
Boyden, in the same field of endeavor, teaches further comprising an elastic band including an elastic material to press the flexible substrate, the adapter or both (fig. 1; paragraph 192).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the substrate and adapter of Szabados in view of Allen in view of Hsu to add an elastic band from Boyden for the benefit of securing the bio-signal measuring device to the patient.
Regarding claim 9, Szabados in view of Allen in view of Hsu does not explicitly teach wherein
the elastic band comprises a buckle device or Velcro fabric at both ends, so that the both ends of the elastic band are connected and detachable.
Boyden, in the same field of endeavor, teaches wherein the elastic band comprises a buckle device or Velcro fabric at both ends, so that the both ends of the elastic band are connected and detachable (fig. 1; paragraph 192). The sensor component 136 can be held in place using one or more fastening components including for example, but not limited to, elastic bands, hook and loop fasteners, clip-type devices, buckles, straps, snaps, clamps, or the like.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the substrate and adapter of Szabados in view of Allen in view of Hsu to add an elastic band from Boyden for the benefit of securing the bio-signal measuring device to the patient.
Regarding claim 10, Szabados in view of Allen in view of Hsu does not explicitly teach wherein
they at least one adapter is embedded into the elastic band or integrated into the elastic band.
Boyden, in the same field of endeavor, teaches wherein the at least one adapter is embedded into the elastic band or integrated into the elastic band (fig. 1; paragraph 192). The sensor component 136 can be held in place or embedded using one or more fastening components including for example, but not limited to, elastic bands.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the substrate and adapter of Szabados in view of Allen in view of Hsu to add an elastic band from Boyden for the benefit of securing the bio-signal measuring device to the patient.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Szabados in view of
Allen in view of Roham et al. US Pub.: US 20130116520 A1, hereinafter Roham.
Regarding claim 11, Szabados in view of Allen teaches the claimed invention and Szabados
further teaches an ECG sensor installed in the flexible substrate and configured to generate an ECG signal by sensing a current or a voltage.
Szabados in view of Allen as modified, does not teach wherein a sensor electrode of the plurality of sensor electrodes comprises a capacitor sensor installed in the housing and configured to generate a respiration signal by sensing respiration.
Roham further teaches wherein a sensor electrode of the plurality of sensor electrodes comprises a capacitor sensor installed in the housing and configured to generate a respiration signal by sensing respiration (paragraph 51).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the housing of Szabados in view of Allen to add the capacitance sensor to measure respiration from Roham for the benefit of increasing the comparison technique capabilities of the device for managing several chronic diseases, such as CHF, Asthma and COPD.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Szabados in view of Allen
in view of Roham in view of Toth et al. US Pub.: US 20150335288 A1, hereinafter Toth.
Regarding claim 12, Szabados in view of Allen in view of Roham does not teach further
comprising an alarm unit configured to generate an alarm through a lamp or speaker when a magnitude of the respiration signal or the ECG signal decreases.
Toth, in the same field of endeavor, teaches further comprising an alarm unit configured to generate an alarm through a lamp or speaker when a magnitude of the respiration signal or the ECG signal decreases (paragraph 214-215).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Szabados in view of Allen in view of Roham with the alarm system from Toth for the benefit of providing feedback to the user or physician when a bio signal falls outside a range of normal expectancy.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Szabados in view of
Allen in view of Toth et al. US Pub.: US 20150335288 A1, hereinafter Toth.
Regarding claim 13, Szabados in view of Allen teaches the claimed invention and Szabados
further teaches an acceleration sensor configured to detect a movement (col. 6, lines 1-4).
Toth, in the same field of endeavor, teaches further comprising at least one of an acoustic sensor configured to detect snoring or respiration during sleep (paragraph 231-233).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to modify the patch of Szabados in view of Allen with the acoustic sensors from Toth for the benefit of providing bio-signal information regarding acoustic signals in combination with respiratory data.
Allowable Subject Matter
Claim 7 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The closest art: US 9183738 B1 teaches an adapter with a singular connection connecting a first and second pressing part (fig. 5; col. 4, lines 17-68). However, the examiner found no art to teach every limitation of the dependent claim 7, specifically, “wherein the first pressing part and the second pressing part are connected solely by the single connection part along a first longitudinal peripheral edge of the at least one adapter, and wherein the first pressing part, the single connection part, and the second pressing part together define the housing groove,” in combination with the rest of independent claim 1.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THIEN J TRAN whose telephone number is (571)272-0486. The examiner can normally be reached M-F. 8:30 am - 5:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at 571-270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/T.J.T./Examiner, Art Unit 3792
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792
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