DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendment filed September 10th, 2025 has been entered. Claims 1-10 remain pending in the application. Applicant’s amendments to the claims have overcome the objections and rejections previously set forth in the Non-Final Office Action mailed June 16th, 2025.
Response to Arguments
Applicant’s arguments with respect to claims 1-10 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The claim amendments changed the scope of the claimed invention. See new grounds for rejection below.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1, line 2, recites “wherein the flat- bed knit-based electrode” should read -- wherein the flat-bed knit-based electrode structure comprises: --.
Claim 1, line 10, recites “wherein the flat-bed knit-based electrode structure 1 is provided with a non-electrically” should read -- wherein the flat-bed knit-based electrode structure
Claim 1, line 16, recites “area comprising a v that is isolated on the borders of the non-electrically conductive, permeable”, should read -- area comprising a third fabric that is isolated on the borders of the non-electrically conductive, permeable --.
Claim 1, line 13 recites “yarn to the neighbouring needles for two courses, creating a hole on the front and back of the” should read – yarn to the neighboring needles for two courses, creating a hole on the front and back of the -- (it is recommended to use the US spelling of words rather than the UK spelling).
Appropriate correction is required.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 2, 4-6, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Lindberg et al. (US 20070285868 A1) herein referred to as “Lindberg” in view of Oleson et al. (US 20140189928 A1) herein referred to as “Oleson” further in view of DeFusco et al. (US 20070127187 A1) herein referred to as “DeFusco”.
Regarding claim 1, Lindberg discloses a flat-bed knit-based electrode structure for measuring an ECG signal on the skin of a person's chest, wrist or arm ( the sensory according to the invention is suitable for use in detecting the heart rate from the skin, from the chest, Paragraph [0087], and Paragraphs [0040], [0042], [0049], [0089], with the aid of the sensor structure described, it is possible to manufacture medical sensors for electrocardiography (ECG), Paragraph [0045], ), wherein the electrode structure comprises: a band-like component having an inner flat-bed knitted conductive surface to be placed against the skin of the person's chest (electrode structure 35, Abstract, Figure 3, the electrode can be made of metal, or a conductive plastic, elastomer, individual fibers, or of a fiber material, such as a woven or knitted fabric, Paragraph [0057], Figure 3), the band-like component having a first electrically conductive region and a second electrically conductive region (first electrically conductive region 35 on the left and other electrode on the right, see modified Figure 3 below),
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wherein the electrode structure is arranged to measure a heart rate between the electrodes from the skin (the sensory according to the invention is suitable for use particularly in detecting the heart rate of the heart from the skin, for example, from the chest, the sensory also typically comprises a second electrode like that described above and a second corresponding signal conductor to be placed on a different side of the chest, Paragraph [0087]),
wherein the flat-bed knit-based electrode structure is provided with a non-electrically conductive, permeable area comprising a first fabric, wherein the first fabric is permeable for airflow (the sensory can be manufactured as a part of a heart rate belt, in which case the textile material of these can as such as the substrate of the sensory, Paragraphs [0088]-[0090], the substrate can be, for example, of a textile material manufactured from natural fibers and/or artificial fibers, the material can be woven or non-woven, if is preferably self-breathing, i.e. by air and water vapor, and often also water, thus it creates a comfortable feeling against the user’s skin, Paragraph [0025]); wherein the first fabric is formed using a double bed knitting technique with transfer of yarn to the neighbouring needled for two courses, creating a hole on the front and back of the first fabric (seen as product by process limitation, “wherein the first fabric is formed using a double bed knitting technique with transfer of yarn to the neighbouring needles for two courses, creating a hole on the front and back of the first fabric” has no patentable weight as the same first fabric could be produced with a different process);
wherein the flat-bed knit-based electrode structure includes a non-electrically conductive area comprising a v that is isolated on the borders of the non-electrically conductive, permeable area and in-between the first electrically conductive region and the second electrically conductive region (substrate extends between the electrodes, Figures 1-5, the substrate can be, for example, of a textile material manufactured from natural fibers and/or artificial fibers, the material can be woven or non-woven, if is preferably self-breathing, i.e. by air and water vapor, and often also water, thus it creates a comfortable feeling against the user’s skin, Paragraph [0025]); wherein the fabric is formed using a double bed knitting technique compromised of plaiting with transfer knitting shifting from front needle bed to the back needle bed (seen as product by process limitation, “wherein the third fabric is formed using a double bed knitting technique compromised of plaiting with transfer knitting shifting from front needle bed to the back needle bed” has no patentable weight as the same third fabric could be produced with a different process).
However Lindberg does not explicitly disclose wherein the outer surface of the band-like component has electrically conductive fibers.
DeFusco discloses a wrist band for use with a cardiac patient remote monitoring system including fabric layers with integral textile-based electrodes (Abstract) wherein the outer surface of the band-like component has electrically conductive fibers (the wrist band may include a comfortable stretch-recovery knit, with portions of the skin contacting surface and the outer surface having electrically conductive fibers therein, Paragraph [0018]).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Lindberg to incorporate
the teachings of DeFusco by including wherein the outer surface of the band-like component has electrically conductive fibers. The motivation to do so being to incorporate a textile-based electrode comprising conductive regions that partially overlap which results in electrical conduction between the electrically conductive regions (DeFusco, Paragraph [0115]).
Lastly, Lindberg does not explicitly disclose wherein the electrode structure is arranged to measure a potential difference between the first and the second electrically conductive regions caused by the ECG signal.
Oleson discloses wherein the electrode structure is arranged to measure a potential difference between the first and the second electrically conductive regions caused by the ECG signal (a measurable potential difference is thus produced between the first electrode 16a and the second electrode 16b (e.g., an ECG signal which is measured with the electronics components within the electronics module 22), Paragraph [0035]).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Lindberg to incorporate
the teachings of Oleson by including wherein the electrode structure is arranged to measure a potential difference between the first and the second electrically conductive regions caused by the ECG signal. The motivation to do so being record an ECG signal through the two electrodes in contact with the skin (Oleson, Paragraph [0035]).
Regarding claim 2, Lindberg in view of Oleson and DeFusco discloses the electrode structure of claim 1.
Lindberg discloses wherein the band-like component of the electrode structure is a continuous band made of a flat-bed knitted textile that is a flexible, soft and air permeable material that fits closely to the skin (the elastic belt or band to be stretched around the chest can be manufactured to be continuous from some other layer of the structure (i.e., the substrate), Paragraph [0089], the substrate is preferably a textile material, Paragraph [0010], [0014], [0015], [0025], [0061], [0062], flexible band, Paragraph [0049], flexible and moisture-permeable substrate, Paragraph [0055], wherein the substrate is a textile material, it is preferably self-breathing, i.e., permeable to air and water vapor, Paragraph [0025]).
Regarding claim 4, Lindberg in view of Oleson and DeFusco discloses the electrode structure of claim 1.
Lindberg further discloses wherein the first electrically conductive region and the second electrically conductive region of the electrode structure each form a conductive electrode (flexible substrate 30 comprising at least one electrode 35 (first and second electrode see modified Figure 3 below), Abstract).
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Regarding claim 5, Lindberg in view of Oleson and DeFusco discloses the electrode structure of claim 1.
Lindberg further discloses wherein each of the first electrically conductive region and the second electrically conductive region have a width that is less than a width of the band-like component (conductive region 35, 34, and 31 is less than a width of the band-like component 30, Figure 3).
Regarding claim 6, Lindberg in view of Oleson and DeFusco discloses the electrode structure of claim 1.
Lindberg further discloses wherein the electrode structure comprises a monitoring unit in communication with the first electrically conductive region and the second electrically conductive region, wherein the monitoring unit receives ECG data from the first electrically conductive region and the second electrically conductive region and outputs heart rate information derived from the ECG data (the sensor can further comprise an installation zone 32 that connects to the conductors 34 of the electrodes 35, Figure 3, Abstract, the electronics module typically contains means for transmitting, recording, or displaying a measured physiological signal, typically it comprises a wireless signal transmitter, the terminal of which being, a computer or some other heart-rate monitor, Paragraph [0094]).
Regarding claim 10, Lindberg in view of Oleson and DeFusco discloses the electrode as claimed in claim 1.
Lindberg further discloses wherein the electrode structure is integrated into a wearable article, such as a chest strap, arm band or wrist band (the elastic belt or band to be stretched around the chest, Paragraph [0042], [0049], and [0089]).
Claims 3 and 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Lindberg in view of Oleson and DeFusco further in view of Yuen (US 20130131460 A1) herein referred to as “Yuen”.
Regarding claim 3, Lindberg in view of Oleson and DeFusco discloses the electrode structure of claim 1.
However Lindberg in view of Oleson and DeFusco does not explicitly disclose wherein the first electrically conductive region and the second electrically conductive region of the electrode structure are electrically insulated from one another.
Yuen discloses wherein the first electrically conductive region and the second electrically conductive region of the electrode structure are electrically insulated from one another (the strap is usually made of soft plastics to provide flexibility for body wearing and electrical insulation between the electrodes, Paragraph [0005], the skin contact portion may elevate from the signal collection pad and may be surrounded by an insulating material, Paragraph [0011], the signal collection pad of each of the electrodes may be bonded on the insulated strap, Paragraph [0025], electrodes 120, 140, and elastic strap 180, Paragraph [0046], Figures 1-5A).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Lindberg in view of Oleson and DeFusco to incorporate the teachings of Yuen by including wherein the first electrically conductive region and the second electrically conductive region of the electrode structure are electrically insulated from one another. The motivation to do so being to prevent signal interference and spurious signals (Yuen, Paragraphs [0010] and [0005]).
Regarding claim 7, Lindberg in view of Oleson and DeFusco discloses the electrode structure as claimed in claim 6.
Lindberg further discloses wherein the monitoring unit is in connection with the first and second electrically conductive regions (electronics module connects to the conductors through connection points 171, Figure 2b, Paragraph [0036] and [0093], Figures 2b and Figure 6).
Lindberg does disclose wherein the electrode structure comprises one or more connections for attaching the monitoring unit to the first and second electrically conductive regions of the electrode structure (contact openings 171, Paragraph [0036], and [0093], Figures 2b and Figure 6). However Lindberg in view of Oleson and DeFusco does not explicitly disclose wherein the electrode structure comprises one or more snaps for attaching the monitoring unit to the first and second electrically conductive regions of the electrode structure.
Yuen discloses wherein the electrode structure comprises one or more snaps for attaching the monitoring unit to the first and second electrically conductive regions of the electrode structure (the conductive fastening components of the two ECG signal collection electrodes are located at opposite longitudinal ends of the strap and are arranged to convert the longitudinal strap into a strap loop when the fastening components are respectively anchored onto corresponding or counterpart fastening components, each conductive fastening component comprises a mechanical mating portion which is adapted for making counterpart engagement with another compatible mechanical mating portion of a compatible fastener, example of suitable fasteners includes a snap fit fastener or a magnetic clasp, Paragraph [0047], mobile ECG signal processor 200 includes means for capturing and processing the detected ECG signals wherein the ECG signal processor includes a rigid housing and a pair of signal input terminals, each signal input terminal is a fastening component having a rigid mechanical mating portion which is configured to engage with a corresponding fastening component of the chest strap, Paragraph [0051], Figures 4, 4A, 5 and 6).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Lindberg in view of Oleson and DeFusco to incorporate the teachings of Yuen by including wherein the electrode structure comprises one or more snaps for attaching the monitoring unit to the first and second electrically conductive regions of the electrode structure. The motivation to do so being to provide a secure snap connection to facilitate mechanical and electrical connections for added convenience (Yuen, Paragraphs [0023] and [0051]).
Regarding claim 8, Lindberg in view of Oleson, DeFusco, and Yuen discloses the electrode structure as claimed in claim 7.
However Lindberg does not explicitly disclose wherein the one or more snaps are configured to attach the first and second electrically conductive regions to a surface of the monitoring unit casing which faces the person's skin.
Oleson discloses wherein the one or more snaps are configured to attach the first and second electrically conductive regions to a surface of the monitoring unit casing which faces the person's skin (the connection pins 80 (seen as snaps) that engages the electrode leads 50 within the contoured base 90, Paragraph [0046], wherein the receptacle 20 is configured to receive and retain the electronics module 22 within the socket 94 and also facilitate electrical connection between the electronics module 22 and the electrodes 16 of the sensor arrangement, Paragraph [0046], wherein the casing faces the person’s skin, Figures 3 and 5, see also Paragraph [0041]).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Lindberg in view of Oleson and DeFusco to incorporate the teachings of Oleson by including wherein the one or more snaps are configured to attach the first and second electrically conductive regions to a surface of the monitoring unit casing which faces the person's skin. The motivation to do so being to engage the connection pins with the electrode leads to ensure an electrical connection between the electronics module and the electrodes (Oleson, Paragraph [0046]).
Regarding claim 9, Lindberg in view of Oleson, DeFusco, and Yuen discloses the electrode structure as claimed in claim 7.
However Lindberg in view of Oleson, DeFusco, and Yuen does not explicitly disclose wherein the one or more snaps form an electric coupling between the first and second electrically conductive regions and the monitoring unit.
Yuen discloses wherein the one or more snaps form an electric coupling between the first and second electrically conductive regions and the monitoring unit (the conductive fastening components of the two ECG signal collection electrodes are located at opposite longitudinal ends of the strap and are arranged to convert the longitudinal strap into a strap loop when the fastening components are respectively anchored onto corresponding or counterpart fastening components, each conductive fastening component comprises a mechanical mating portion which is adapted for making counterpart engagement with another compatible mechanical mating portion of a compatible fastener, example of suitable fasteners includes a snap fit fastener or a magnetic clasp, Paragraph [0047], mobile ECG signal processor 200 includes means for capturing and processing the detected ECG signals wherein the ECG signal processor includes a rigid housing and a pair of signal input terminals, each signal input terminal is a fastening component having a rigid mechanical mating portion which is configured to engage with a corresponding fastening component of the chest strap, Paragraph [0051], Figures 4, 4A, 5 and 6).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Lindberg in view of Oleson, DeFusco, and Yuen to incorporate the teachings of Yuen by including wherein the one or more snaps form an electric coupling between the first and second electrically conductive regions and the monitoring unit. The motivation to do so being to provide a secure snap connection to facilitate mechanical and electrical connections for added convenience (Yuen, Paragraphs [0023] and [0051]).
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 Dana Stumpfoll whose telephone number is (703)756-4669. The examiner can normally be reached 9-5 pm (CT), M-F.
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/D.S./Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794