DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim 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.
Claim(s) 1-3, 5-7, 10-13, and 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2020/060780 Albert, hereinafter “Albert”, in view of US 2016/0287172 Morris et al., hereinafter “Morris”(both cited previously), further in view of WO 2020/086726 Hamner et al., hereinafter “Hamner”.
Regarding claim 1, Albert discloses an apparatus (Abstract, Para 68, and Figure 6, element 600) comprising: a band (Para 68 and Annotated Figure 6); a housing (Annotated Figure 6) having an upper portion (Annotated Figure 6, the upper portion is the side facing element 604) and a lower portion (Annotated Figure 6, the lower portion is the side facing element 606), wherein the band is a continuous band (Annotated Figure 6 shows a continuous band attached to electrodes 604 and 606, still see design choice rejection below); a plurality of electrodes (Figure 6, elements 604, 606, and 608), each of the plurality of electrodes to contact a location on a body of a user when the band is coupled to the user (Para 68; every electrode is meant to contact a different location in the body), and wherein: each of a first subset of the plurality of electrodes is mounted on the band (Para 68 and Figure 6, element 608 is the first subset is on the band) and wherein a user facing side of the band comprises a first electrode of the first subset of the plurality of electrodes that contacts the leg of the user (This could be interpreted in one of two ways and examiner believes the reference reads on both interpretations. First, a user facing side can be interpreted to mean either side. When wearing a watch, one can interpret the user facing side to be either the part that is contacting the wrist, as it faces the user, or it could be the part that faces the body of the user, i.e. the outside of the band. If interpreting it as the latter, Para 68 and Figure 6, element 608 disclose that the electrode 608 contacts the lower left extremity of the user, i.e. the leg. If you choose to go with the first interpretation, the disclosure of Figure 1B, Figure 5, and Para 43, 45, and 75 disclose that the user facing side of the device can contact the lower extremity and the device can be any type of wearable device, therefore it is okay to assume that it can be configured as a band around the user’s leg. Examiner suggests defining the meaning of “a user facing side”), wherein the user-facing side of the band is an external surface of the band that is opposite a body part of the user when the band is coupled to the body part of the user (Para 68 and Figure 6, element 608 is on the outside of the band, i.e. on an external surface, therefore on the defined user-facing side), wherein any portion of the user-facing side of the band is to contact the leg of the user (Para 68 and Figure 6, element 608 disclose that the electrode 608 contacts the lower left extremity of the user, i.e. the leg, this electrode is any portion of the band, however, also look at rejection in view of Morris); and each of a second subset of the plurality of electrodes is mounted on the housing (Para 68 and Figure 6, element 604 and 606; electrodes 604 and 606 are on the housing as shown in annotated Figure 6), and each of the second subset of electrodes measures electrical activity of a heart of the user (Para 68; used to measure the ECG of the user); a memory mounted on the housing (Para 5 and 79); and the processing device mounted on the housing and operatively coupled to the plurality of electrodes and the memory (Para 5 and 6), the processing device to: perform, using the plurality of electrodes, a six-lead electrocardiogram (ECG) of the user (Para 27, 60, and 68; see also Abstract).
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Annotated Figure 6
Albert does not disclose the housing is received by an opening of the band and comprises the opening adjacent a first end of the band, wherein the band is interposed between the upper portion and the lower portion; the band comprises a conductive fabric that functions as a first electrode of the first subset of the plurality of electrodes that contacts the user; wherein any portion of the user-facing side of the band is to contact the leg of the user.
However, Morris discloses a wrist-worn device that measures a heart signal via electrodes (Abstract) and teaches the housing (Annotated Figure 1 below, elements 40 and 42) is received by an opening of the band (Annotated Figure 1 below) and comprises the opening adjacent a first end of the band (Annotated Figure 1 below), wherein the band is interposed between the upper portion and the lower portion (Annotated Figure 1 below; the band sits in the middle of upper portion 40 and lower portion 42, this is also shown clearly in Figures 3 and 4A); the band comprises a conductive fabric that functions as a first electrode of the first subset of the plurality of electrodes that contacts the user (Figures 4A, 4B and 4C and Para 59-62 show a conductive band 410 that comprises conductive elastomers that act as conductive zones and are electrodes 422a-c and 424a-c, see “Response to Arguments” section for further clarification); wherein any portion of the user-facing side of the band is to contact the leg of the user (Para 66 and Figure 5A, any portion of the outside of the band 300 can contact the users leg).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed an opening in the band and a conductive fabric as taught by Morris, in the invention of Albert, in order to connect the band to the housing of the device and allow it to be wearable and allow electrical connection to the primary device and allow the band to act as a conducting electrode (Morris; Para 19 and 59-60).
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Annotated Figure 1 (Morris)
Even if Albert does not disclose the band is a continuous band.
At the time the invention was made, it would have been an obvious matter of design choice to a person of ordinary skill in the art to have included a band that is continuous instead of separable as shown in Morris because Applicant has not disclosed that the band being continuous provides an advantage, is used for a particular purpose, or solves a stated problem over the prior art (see MPEP 2144.04 [R-10.2019], section VE “MAKING PORTABLE, INTEGRAL, SEPARABLE, ADJUSTABLE, OR CONTINUOUS”). One of ordinary skill in the art, furthermore, would expect Morris’s device, to perform equally as well as the applicant’s invention in terms of carrying the housing within the wrist worn device, with the band being interposed between housing portions.
Therefore, it would have been prima facie obvious to modify Morris to obtain the invention as specified in claim 1, because such a modification would have been considered a mere design consideration which fails to patentably distinguish over the prior art of Albert and Morris.
Albert does not disclose the band includes a cut-out portion less than a width of the band to define the opening, wherein the band comprising a flexible printed circuit to provide a conductive channel along an entirety of the band to route signals from each of the plurality of electrodes to a processing device within the housing.
However, Hamner discloses a wearable therapy system (Figure 5A and Para 129) and teaches the band (figure 5A, element 500) includes a cut-out portion (Figure 5A, element 506) less than a width of the band (This is clear in Figure 5A, the opening 506 is less than the width of band 500) to define the opening (Figure 5A, element 506), wherein the band comprising a flexible printed circuit (Figure 5A, element 505) to provide a conductive channel (Para 129; also note that this limitation is a statement of intended use, examiner suggests positively reciting this limitation) along an entirety of the band to route signals from each of the plurality of electrodes to a processing device within the housing (Figure 5A, circuit 505 runs through the band to connect electrodes 504 to processing device 501/503 through pins 507, see Para 129).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed an opening in the band and a FPCB as taught by Hamner, in the invention of Albert, in order to connect the band to the housing of the device and allow it to be wearable and allow electrical connection to the primary device and allow the band to act as a conductor (Hamner; Para 129).
Regarding claim 2, Albert discloses a first electrode of the second subset of the plurality of electrodes is positioned on a non-user facing side of the housing to contact a first location of a user (Figure 6, element 604 to contact a user’s finger, see Figure 7 and Para 68), a second remaining electrode of the second subset of the plurality of electrodes is positioned on the user facing side of the housing to contact a second location of the user (Figure 6, element 606 to contact a user’s skin, see Para 68), and each of the first subset of the plurality of electrodes are positioned on the user-facing side of the band, wherein one of the first subset of the plurality of electrodes contacts a third location of the user (Para 60, 68, and Figure 6, element 608; this electrode is facing the user and contacting the lower extremities and/or chest).
Regarding claim 3, Albert discloses each of the plurality of electrodes is isolated from a location on the body of the user that another electrode of the plurality of electrodes is contacting (Para 60, 68, Figure 6, elements 604, 606, and 608; first electrode is contacting wrist, second is at the lower extremity, and the third electrode is contacting the chest).
Regarding claim 5, Albert discloses the band (Para 68 and Figure 6).
Albert does not disclose the band comprises an elastic material permitting a circumference of the band to adjust based on a size of the user.
However, Morris teaches the band comprises an elastic material permitting a circumference of the band to adjust based on a size of the user (Para 19 and 21).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed an elastic band as taught by Morris, in the invention of Albert, in order to allow the band to be adjusted to the circumference of the user (Morris; Para 19 and 21).
Regarding claim 6, Albert discloses the first location of the user corresponds to a left arm of the user or a right arm of a user (Para 60, 68, and Figure 6; element 606 is contacting one of the wrists of the user) and each of the second and third locations of the user each correspond to one of: a left leg of the user, a right leg of the user, a left hand of the user, a right hand of the user, and a chest of the user (Para 60 and 68; elements 604 and 608 contact the lower extremity, i.e. the legs and chest respectively and the finger on a hand of a user see Figure 7).
Regarding claim 7, Albert discloses a first electrode of the plurality of electrodes maintains constant contact with the body of the user (Para 68 and Figure 6, element 606 is always contacting the body as long as the user has the watch on) and the processing device performs the six- lead ECG of the user in response to determining that a second electrode and a third electrode of the plurality of electrodes have made contact with the body of the user (Abstract and Para 68).
Regarding claim 10, Albert discloses the processing device (Para 5 and 6) is further to: determine one or more diagnoses based on a set of ECG waveforms generated by the six- lead ECG (Para 121); and transmit, via a transceiver, the one or more diagnoses to a computing device (Para 64, 68, 70, and 121).
Regarding claim 11, Albert discloses a system (Abstract, Para 68, and Figure 6, element 600) comprising: a computing device (Para 5); and a monitoring device (Para 5 and Figure 6) comprising: a band (Para 68 and Annotated Figure 6); a housing (Annotated Figure 6) having an upper portion (Annotated Figure 6, the upper portion is the side facing element 604) and a lower portion (Annotated Figure 6, the lower portion is the side facing element 606), wherein the band is a continuous band (Annotated Figure 6 shows a continuous band attached to electrodes 604 and 606, still see design choice rejection below); a plurality of electrodes (Figure 6, elements 604, 606, and 608), each of the plurality of electrodes to contact a location on a body of a user when the band is coupled to the user (Para 68; every electrode is meant to contact a different location in the body), and wherein: each of a first subset of the plurality of electrodes is mounted on the band (Para 68 and Figure 6, element 608 is the first subset is on the band) and wherein a user facing side of the band comprises a first electrode of the first subset of the plurality of electrodes that contacts the leg of the user (This could be interpreted in one of two ways and examiner believes the reference reads on both interpretations. First, a user facing side can be interpreted to mean either side. When wearing a watch, one can interpret the user facing side to be either the part that is contacting the wrist, as it faces the user, or it could be the part that faces the body of the user, i.e. the outside of the band. If interpreting it as the latter, Para 68 and Figure 6, element 608 disclose that the electrode 608 contacts the lower left extremity of the user, i.e. the leg. If you choose to go with the first interpretation, the disclosure of Figure 1B, Figure 5, and Para 43, 45, and 75 disclose that the user facing side of the device can contact the lower extremity and the device can be any type of wearable device, therefore it is okay to assume that it can be configured as a band around the user’s leg. Examiner suggests defining the meaning of “a user facing side”), wherein the user-facing side of the band is an external surface of the band that is opposite a body part of the user when the band is coupled to the body part of the user (Para 68 and Figure 6, element 608 is on the outside of the band, i.e. on an external surface, therefore on the defined user-facing side), wherein any portion of the user-facing side of the band is to contact the leg of the user (Para 68 and Figure 6, element 608 disclose that the electrode 608 contacts the lower left extremity of the user, i.e. the leg, this electrode is any portion of the band, however, also look at rejection in view of Morris); and each of a second subset of the plurality of electrodes is mounted on the housing (Para 68 and Figure 6, element 604 and 606; electrodes 604 and 606 are on the housing as shown in annotated Figure 6), and each of the second subset of electrodes measures electrical activity of a heart of the user (Para 68; used to measure the ECG of the user); a memory mounted on the housing (Para 5 and 79); and the processing device mounted on the housing and operatively coupled to the plurality of electrodes and the memory (Para 5 and 6), the processing device to: perform, using the plurality of electrodes, a six-lead electrocardiogram (ECG) of the user (Para 27, 60, and 68; see also Abstract); determine one or more diagnoses based on a set of ECG waveforms generated by the six- lead ECG (Para 121); and transmit, via a transceiver, the one or more diagnoses to a computing device (Para 64, 68, 70, and 121).
Albert does not disclose the housing is received by an opening of the band and comprises the opening adjacent a first end of the band, wherein the band is interposed between the upper portion and the lower portion; the band comprises a conductive fabric that functions as a first electrode of the first subset of the plurality of electrodes that contacts the user; wherein any portion of the user-facing side of the band is to contact the leg of the user.
However, Morris discloses a wrist-worn device that measures a heart signal via electrodes (Abstract) and teaches the housing (Annotated Figure 1, elements 40 and 42) is received by an opening of the band (Annotated Figure 1) and comprises the opening adjacent a first end of the band (Annotated Figure 1), wherein the band is interposed between the upper portion and the lower portion (Annotated Figure 1; the band sits in the middle of upper portion 40 and lower portion 42, this is also shown clearly in Figures 3 and 4A); the band comprises a conductive fabric that functions as a first electrode of the first subset of the plurality of electrodes that contacts the user (Figures 4A, 4B and 4C and Para 59-62 show a conductive band 410 that comprises conductive elastomers that act as conductive zones and are electrodes 422a-c and 424a-c); wherein any portion of the user-facing side of the band is to contact the leg of the user (Para 66 and Figure 5A, any portion of the outside of the band 300 can contact the users leg).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed an opening in the band and a conductive fabric as taught by Morris, in the invention of Albert, in order to connect the band to the housing of the device and allow it to be wearable and allow electrical connection to the primary device and allow the band to act as a conducting electrode (Morris; Para 19 and 59-60).
Even if Albert does not disclose the band is a continuous band.
At the time the invention was made, it would have been an obvious matter of design choice to a person of ordinary skill in the art to have included a band that is continuous instead of separable as shown in Morris because Applicant has not disclosed that the band being continuous provides an advantage, is used for a particular purpose, or solves a stated problem over the prior art (see MPEP 2144.04 [R-10.2019], section VE “MAKING PORTABLE, INTEGRAL, SEPARABLE, ADJUSTABLE, OR CONTINUOUS”). One of ordinary skill in the art, furthermore, would expect Morris’s device, to perform equally as well as the applicant’s invention in terms of carrying the housing within the wrist worn device, with the band being interposed between housing portions.
Therefore, it would have been prima facie obvious to modify Morris to obtain the invention as specified in claim 11, because such a modification would have been considered a mere design consideration which fails to patentably distinguish over the prior art of Albert and Morris.
Albert does not disclose the band includes a cut-out portion less than a width of the band to define the opening, wherein the band comprising a flexible printed circuit to provide a conductive channel along an entirety of the band to route signals from each of the plurality of electrodes to a processing device within the housing.
However, Hamner discloses a wearable therapy system (Figure 5A and Para 129) and teaches the band (figure 5A, element 500) includes a cut-out portion (Figure 5A, element 506) less than a width of the band (This is clear in Figure 5A, the opening 506 is less than the width of band 500) to define the opening (Figure 5A, element 506), wherein the band comprising a flexible printed circuit (Figure 5A, element 505) to provide a conductive channel (Para 129; also note that this limitation is a statement of intended use, examiner suggests positively reciting this limitation) along an entirety of the band to route signals from each of the plurality of electrodes to a processing device within the housing (Figure 5A, circuit 505 runs through the band to connect electrodes 504 to processing device 501/503 through pins 507, see Para 129).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed an opening in the band and a FPCB as taught by Hamner, in the invention of Albert, in order to connect the band to the housing of the device and allow it to be wearable and allow electrical connection to the primary device and allow the band to act as a conductor (Hamner; Para 129).
Regarding claim 12, Albert discloses a first electrode of the second subset of the plurality of electrodes is positioned on a non-user facing side of the housing to contact a first location of a user (Figure 6, element 604 to contact a user’s finger, see Figure 7 and Para 68), a second remaining electrode of the second subset of the plurality of electrodes is positioned on the user facing side of the housing to contact a second location of the user (Figure 6, element 606 to contact a user’s skin, see Para 68), and each of the first subset of the plurality of electrodes are positioned on the user-facing side of the band, wherein one of the first subset of the plurality of electrodes contacts a third location of the user (Para 60, 68, and Figure 6, element 608; this electrode is facing the user and contacting the lower extremities and/or chest).
Regarding claim 13, Albert discloses each of the plurality of electrodes is isolated from a location on the body of the user that another electrode of the plurality of electrodes is contacting (Para 60, 68, Figure 6, elements 604, 606, and 608; first electrode is contacting wrist, second is at the lower extremity, and the third electrode is contacting the chest).
Regarding claim 15, Albert discloses the band (Para 68 and Figure 6).
Albert does not disclose the band comprises an elastic material permitting a circumference of the band to adjust based on a size of the user.
However, Morris teaches the band comprises an elastic material permitting a circumference of the band to adjust based on a size of the user (Para 19 and 21).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed an elastic band as taught by Morris, in the invention of Albert, in order to allow the band to be adjusted to the circumference of the user (Morris; Para 19 and 21).
Regarding claim 16, Albert discloses the first location of the user corresponds to a left arm of the user or a right arm of a user (Para 60, 68, and Figure 6; element 606 is contacting one of the wrists of the user) and each of the second and third locations of the user each correspond to one of: a left leg of the user, a right leg of the user, a left hand of the user, a right hand of the user, and a chest of the user (Para 60 and 68; elements 604 and 608 contact the lower extremity, i.e. the legs and chest respectively; see Figure 7 for finger on either hand).
Regarding claim 17, Albert discloses a first electrode of the plurality of electrodes maintains constant contact with the body of the user (Para 68 and Figure 6, element 606 is always contacting the body as long as the user has the watch on) and the processing device performs the six- lead ECG of the user in response to determining that a second electrode and a third electrode of the plurality of electrodes have made contact with the body of the user (Abstract and Para 68).
Claim(s) 8 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2020/060780 Albert, hereinafter “Albert”, in view of US 2016/0287172 Morris et al., hereinafter “Morris”, further in view of WO 2020/086726 Hamner et al., hereinafter “Hamner”, further in view of US 2021/0195732 Longinotti-Buitoni et al., hereinafter “Longinotti” (cited previously).
Regarding claim 8, Albert discloses a display mounted on the band and operatively coupled to the memory (Para 5 and 68).
Albert does not disclose one or more optical sensors to detect motions of the user and positions of the user, the one or more optical sensors mounted on the band and operatively coupled to the memory and the processing device.
However, Longinotti teaches one or more optical sensors to detect motions of the user and positions of the user, the one or more optical sensors mounted on the band and operatively coupled to the memory and the processing device (Para 334, see also Para 68 and 304).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed an optical sensor as taught by Longinotti, in the invention of Albert, in order to sense position and movement of the user (Longinotti; Para 334).
Regarding claim 18, Albert discloses a display mounted on the band and operatively coupled to the memory (Para 5 and 68).
Albert does not disclose one or more optical sensors to detect motions of the user and positions of the user, the one or more optical sensors mounted on the band and operatively coupled to the memory and the processing device.
However, Longinotti teaches one or more optical sensors to detect motions of the user and positions of the user, the one or more optical sensors mounted on the band and operatively coupled to the memory and the processing device (Para 334, see also Para 68 and 304).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed an optical sensor as taught by Longinotti, in the invention of Albert, in order to sense position and movement of the user (Longinotti; Para 334).
Response to Arguments
Applicant’s arguments have been fully considered but are moot because the new ground of rejection.
Examiner agrees with the arguments and amendments made by applicant and has responded with a new 103 rejection on record based on the amended claim. Refer above for rejection. Examiner would first like to point out that Figure 6 of Albert does show a continuous band. Examiner interpreted the disclosure of Figure 1 of Morris as showing an opening in the housing. However, examiner does agree that Morris and Albert both do not disclose that the band includes a cut-out portion less than a width of the band to define the opening. For this reason, examiner relied on Hamner to disclose that limitation as shown in Figure 5A. Hamner also teaches the idea of a FPCB that runs across the band to act as a conductor to the electrodes in the band. This teaching has motivation to be combined with references Albert and Morris as disclosed in the rejection above.
Also note relevant reference US 10,485,477 Lapetina et al. This reference was not used in the rejection above, as examiner believes Hamner discloses all the deficiencies of Albert and Morris, however, notes that Lapetina shows “the band includes a cut-out portion less than a width of the band to define the opening” in Figure 5A.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AYA ZIAD BAKKAR whose telephone number is (313)446-6659. The examiner can normally be reached on 7:30 am - 5:00 pm M-Th.
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/AYA ZIAD BAKKAR/
Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796
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