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 § 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, 22, and 25 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. Claims 1, 22, and 25 recite the limitations “A diagnostic component configured to obtain a fluid from under a skin surface of the user and to perform a diagnostic function with the fluid”, “the diagnostic component configured to obtain a fluid from under a skin surface of a user for the diagnostic function”, and “the diagnostic component configured to obtain a fluid from under a skin surface of a user for the diagnostic function”. Examiner did not find any support for this in the specification. The only recitation of “fluid” is in Para 25 of the specification stating “The patch portion 110 may be of the non-invasive type, the absorption type, or the fluidic type of patches”, this does not provide support. Examiner did not find any recitation in the specification that stated “under a skin surface”. The drawings also do not provide any illustration of a component capable of obtaining a fluid (i.e. a needle or the like). For this reason, examiner did not find proper support in the specification and therefore rejects these claims under written description. The limitations “A diagnostic component configured to obtain a fluid from under a skin surface of the user and to perform a diagnostic function with the fluid”, “the diagnostic component configured to obtain a fluid from under a skin surface of a user for the diagnostic function”, and “the diagnostic component configured to obtain a fluid from under a skin surface of a user for the diagnostic function” will not be rejected under art until proper support is shown.
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) 1-12, 15, 21-24, and 26-27 are rejected under 35 U.S.C. 103 as being unpatentable over US 2015/0145676 Adhikari et al., hereinafter “Adhikari”, in view of US 2011/0264001 Cheung et al., hereinafter “Cheung” (both cited previously), further in view of US 8,527,028 Kurzweil et al., hereinafter “Kurzweil”.
Regarding claim 1, Adhikari discloses an integrated patch and bracelet system wearable on a user (Para 27; shown in Figure 8, elements 302 and 802 respectively), the system comprising: a bracelet portion including a central housing member (See Annotated Figure 8) and a pair of straps (See Annotated Figure 8) extending therefrom with each strap having an end (See Annotated Figure 8), the central housing member having a socket formed in a back side thereof (See Annotated Figure 8; both the instant application and Adhikari are non-specific regarding which side is the front or the back of the sensor holding strap, therefore the socket in the Adhikari reference constitutes the backside of the central housing member) and configured to contain a plurality of electronic components (Para 294 and 296-297 disclose that the holding device, i.e. the central housing contains communication tags that include RFID or an NFC tag, which is an electronic component; examiner suggests defining the term electronic components as it’s a very broad term); and a patch portion configured to contain a diagnostic component to perform a diagnostic function (Figure 8, element 302 and Para 27; attachable device 302, could be a diagnostic patch, which would be inherent to have a diagnostic function in the diagnostic patch, see also Para 319) and having a peripheral edge that conforms in shape to the socket formed in the central housing member (See Annotated Figure 8, element 302 is designed in such a way to have a peripheral edge that fits right into the shape of the socket) so that when the patch portion is applied to a skin surface of a user and the bracelet portion is positioned over the patch portion with the ends of the straps secured together around a body part of the user (See Figure 8, also see Para 294, it is inherent that some part of the bracelet portion covers or goes over the patch portion 302 “attachable device 302 configured to be housed in a holding device 802”; Para 99 also makes it clear that the patch 302 is in contact with the skin of the user; in any case also refer to 103 below for another interpretation on this rejection), the patch portion is seated in register within the socket in the central housing member (Para 294; “the electronic system 100 of FIG. 1 with the attachable device 302 configured to be attached to or housed in a holding device 802. The patch portion is the attachable device 302, and the holding device is 802 contains the socket as shown in annotated figure 8) and allowing interoperability between the diagnostic component in the patch portion and at least one electronic component in the central housing member (Para 31," the patch portion 110 may include a passive RFID tag with a coil and the bracelet portion 100 may include a battery with a circuit for directing current flow such that when the coil and circuit are placed in close physical proximity, with EM coupling thereby provided between the two components, the circuit may induce a corresponding current flow in the coil of the RFID tag so that the RFID tag may thereby broadcast over short range its ID signal.” This is an example of the interoperability of the patch and the electronic component in the central housing member).
Adhikari does not explicitly disclose the patch portion is applied to a skin surface of a user and the bracelet portion is positioned over the patch portion.
However, Cheung discloses a wearable sensor system (Abstract and Figure 3) and teaches the patch portion is applied to a skin surface of a user (Figure 2 and 3, elements 10) and the bracelet portion is positioned over the patch portion (Figures 2 and 3, element 14; the band 14 is analogous to a bracelet).
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 the specific sensor holding as taught by Cheung, in the invention of Adhikari, in order to allow the sensors of the diagnostic patch to be held in place against the user’s skin (Cheung; Para 31).
Adhikari does not disclose the back side of the central housing member engages the skin surface around the patch portion.
However, Kurzweil discloses a wearable sensor system (Abstract) and teaches the back side of the central housing member engages the skin surface around the patch portion (Col. 5, lines 3-11 and Figure 11; these show the configuration of the back side of a strap 10, the central housing shown in annotated Figure 11 contacts the skin around the patch portion 150/158; examiner suggests expanding on the term “engaging” as it’s currently very broad).
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 the back side of the central housing member engages the skin surface around the patch portion as taught by Kurzweil, in the invention of Adhikari, in order to provide physiological monitoring (Kurzweil; Abstract).
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Annotated Figure 8 (Adhikari)
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Annotated Figure 11 (Kurzweil)
Regarding claim 2, Adhikari discloses all the limitations of claim 1.
Adhikari does not disclose a dimplet formed in an upper surface of the socket of the central housing member.
However, Kurzweil teaches a dimplet formed in an upper surface of the socket of the central housing member (See annotated Figure 11; Dimplet is a broad term that would encompass a mating snap).
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 a dimplet as taught by Kurzweil, in the invention of Adhikari, in order to electrically conduct the patch (Kurzweil; Col. 10, lines 8-17).
Regarding claim 3, Adhikari discloses all the limitations of claim 1.
Adhikari does not disclose a dome section formed on a top surface of the patch portion, the dome section containing therein at least a portion of the diagnostic component in the patch portion.
However, Kurzweil teaches a dome section formed on a top surface of the patch portion (See figure 11, elements 156/158 forming a dome), the dome section containing therein at least a portion of the diagnostic component in the patch portion (Figure 11, the dome portion includes sensors 156).
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 a dome surface as taught by Kurzweil, in the invention of Adhikari, in order to insure secure and adequate contact with the skin (Kurzweil; Col. 9, lines 65-68).
Regarding claim 4, Adhikari discloses the bracelet portion is positioned over the patch portion with the ends of the straps secured together around the body part of the user (See Figure 8, also see Para 294, it is inherent that some part of the bracelet portion covers or goes over the patch portion 302 “attachable device 302 configured to be housed in a holding device 802”; Para 99 also makes it clear that the patch 302 is in contact with the skin of the user).
Adhikari does not disclose the dome section of the patch portion being seated in register with the dimplet formed in the socket in the central housing member thereby allowing interoperability between the portion of the diagnostic component in the dome section and the at least one electronic component in the central housing member.
However, Kurzweil teaches the dome section of the patch portion being seated in register with the dimplet formed in the socket in the central housing member (See Figure 11; also consider explaining what “in register” means. That term is broad and can be interpreted as “in contact”) thereby allowing interoperability between the portion of the diagnostic component in the dome section and the at least one electronic component in the central housing member (Col. 10, lines 18-28).
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 the patch portion being seated in register with the dimplet as taught by Kurzweil, in the invention of Adhikari, in order to carry the electrical signal to and from the sensors (Kurzweil; Col. 10, lines 18-28).
Regarding claim 5, Adhikari discloses the body part of the user is associated with a body location (Para 101).
Regarding claim 6, Adhikari discloses the body location is an arm location (Para 101).
Regarding claim 7, Adhikari discloses the body location is a middle upper arm or a high upper arm location (Para 210; bicep).
Regarding claim 8, Adhikari discloses the body location is a lower upper arm location (Figure 5, bottom right configuration and Para 210; forearm).
Regarding claim 9, Adhikari discloses the body location is an upper forearm location (Para 210).
Regarding claim 10, Adhikari discloses the body location is a middle forearm location (Figure 5, bottom right configuration and Para 210; forearm).
Regarding claim 11, Adhikari discloses the body location is a wrist location (Para 101).
Regarding claim 12, Adhikari discloses the body location is a torso location (Para 153 and Figure 5, left most configuration).
Regarding claim 15, Adhikari discloses the body location is a leg location (Para 101).
Regarding claim 21, Adhikari discloses the body location is an ankle location (Para 256).
Regarding claim 22, Adhikari discloses a wearable bracelet (Para 27; shown in Figure 8, element 802)comprising: a central housing member (See Annotated Figure 8) having a socket (See Annotated Figure 8) formed in a back side thereof (See Annotated Figure 8; both the instant application and Adhikari are non-specific regarding which side is the front or the back of the sensor holding strap, therefore the socket in the Adhikari reference constitutes the backside of the central housing member) and configured to contain a plurality of electronic components (Para 294 and 296-297 disclose that the holding device, i.e. the central housing contains communication tags that include RFID or an NFC tag, which is an electronic component; examiner suggests defining the term electronic components as it’s a very broad term), the central housing member further configured to receive a patch having a diagnostic component for providing a diagnostic function (Figure 8, element 302 and Para 27; attachable device 302, could be a diagnostic patch, which would be inherent to have a diagnostic function in the diagnostic patch, see also Para 319), the socket dimensioned such that a peripheral edge of the patch substantially conforms in shape to the socket (See Annotated Figure 8, element 302 is designed in such a way to have a peripheral edge that fits right into the shape of the socket) so that when the patch is applied to a skin surface of a user and the bracelet is positioned over the patch (See Figure 8, also see Para 294, it is inherent that some part of the bracelet portion covers or goes over the patch portion 302 “attachable device 302 configured to be housed in a holding device 802”; Para 99 also makes it clear that the patch 302 is in contact with the skin of the user; in any case also refer to 103 below for another interpretation on this rejection), the patch is seated in register within the socket in the central housing member (Para 294; “the electronic system 100 of FIG. 1 with the attachable device 302 configured to be attached to or housed in a holding device 802. The patch portion is the attachable device 302, and the holding device is 802 contains the socket as shown in annotated figure 8), thereby allowing interoperability between the diagnostic component in the patch and at least one electronic component in the central housing member Para 31," the patch portion 110 may include a passive RFID tag with a coil and the bracelet portion 100 may include a battery with a circuit for directing current flow such that when the coil and circuit are placed in close physical proximity, with EM coupling thereby provided between the two components, the circuit may induce a corresponding current flow in the coil of the RFID tag so that the RFID tag may thereby broadcast over short range its ID signal.” This is an example of the interoperability of the patch and the electronic component in the central housing member); and one or more straps extending from the central housing member and configured to allow the bracelet to be secured to a body part associated with the skin surface of the user (See Annotated Figure 8).
Adhikari does not explicitly disclose the patch portion is applied to a skin surface of a user and the bracelet portion is positioned over the patch portion.
However, Cheung discloses a wearable sensor system (Abstract and Figure 3) and teaches the patch portion is applied to a skin surface of a user (Figure 2 and 3, elements 10) and the bracelet portion is positioned over the patch portion (Figures 2 and 3, element 14; the band 14 is analogous to a bracelet).
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 the specific sensor holding as taught by Cheung, in the invention of Adhikari, in order to allow the sensors of the diagnostic patch to be held in place against the user’s skin (Cheung; Para 31).
Adhikari does not disclose the back side of the central housing member engages the skin surface around the patch portion.
However, Kurzweil discloses a wearable sensor system (Abstract) and teaches the back side of the central housing member engages the skin surface around the patch portion (Col. 5, lines 3-11 and Figure 11; these show the configuration of the back side of a strap 10, the central housing shown in annotated Figure 11 contacts the skin around the patch portion 150/158; examiner suggests expanding on the term “engaging” as it’s currently very broad).
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 the back side of the central housing member engages the skin surface around the patch portion as taught by Kurzweil, in the invention of Adhikari, in order to provide physiological monitoring (Kurzweil; Abstract).
Regarding claim 23, Adhikari discloses all the limitations of claim 22.
Adhikari does not disclose the central housing member further includes a dimplet formed in an upper surface of the socket.
However, Kurzweil teaches the central housing member further includes a dimplet formed in an upper surface of the socket (See annotated Figure 11; Dimplet is a broad term that would encompass a mating snap).
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 a dimplet as taught by Kurzweil, in the invention of Adhikari, in order to electrically conduct the patch (Kurzweil; Col. 10, lines 8-17).
Regarding claim 24, Adhikari discloses all the limitations of claim 22.
Adhikari does not disclose the dimplet of the socket is dimensioned to index with a dome section formed on a top surface of the patch.
However, Kurzweil teaches the dimplet of the socket is dimensioned to index with a dome section formed on a top surface of the patch (See figure 11, elements 156/158 forming a dome; the dome portion includes sensors 156, these connect to the socket via mating system 152/160).
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 a dome surface as taught by Kurzweil, in the invention of Adhikari, in order to insure secure and adequate contact with the skin (Kurzweil; Col. 9, lines 65-68).
Regarding claim 26, Adhikari discloses all the limitations of claim 25.
Adhikari does not disclose the patch further includes a dome section formed on a top surface of the patch.
However, Kurzweil teaches the patch further includes a dome section formed on a top surface of the patch (See figure 11, elements 156/158 forming a dome).
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 a dome surface as taught by Kurzweil, in the invention of Adhikari, in order to insure secure and adequate contact with the skin (Kurzweil; Col. 9, lines 65-68).
Regarding claim 27, Adhikari discloses all the limitations of claim 25.
Adhikari does not disclose the dome section of the patch is dimensioned to index with a dimplet formed in an upper surface of the socket of the central housing member.
However, Kurzweil teaches the dome section of the patch is dimensioned to index with a dimplet formed in an upper surface of the socket of the central housing member (See figure 11, elements 156/158 forming a dome; the dome portion includes sensors 156, these connect to the socket via mating system 152/160).
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 a dome surface as taught by Kurzweil, in the invention of Adhikari, in order to insure secure and adequate contact with the skin (Kurzweil; Col. 9, lines 65-68).
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over US 2015/0145676 Adhikari et al., hereinafter “Adhikari”, in view of US 2011/0264001 Cheung et al., hereinafter “Cheung”.
Regarding claim 25, Adhikari discloses a patch (Para 27; shown in Figure 8, element 302) comprising a diagnostic component for providing a diagnostic function (Figure 8, element 302 and Para 27; attachable device 302, could be a diagnostic patch, which would be inherent to have a diagnostic function in the diagnostic patch, see also Para 319), the patch having a shape that substantially conforms to a socket of a central housing member when the patch is seated in register within the socket (See Annotated Figure 8, element 302 is designed in such a way to have a shape that fits right into the shape of the socket), the central housing member having a plurality of electronic components (Para 294 and 296-297 disclose that the holding device, i.e. the central housing contains communication tags that include RFID or an NFC tag, which is an electronic component; examiner suggests defining the term electronic components as it’s a very broad term) and being a part of a bracelet (See Annotated Figure 8), so that when the patch is applied to a skin surface of a user and the bracelet is positioned over the patch (See Figure 8, also see Para 294, it is inherent that some part of the bracelet portion covers or goes over the patch portion 302 “attachable device 302 configured to be housed in a holding device 802”; Para 99 also makes it clear that the patch 302 is in contact with the skin of the user; in any case also refer to 103 below for another interpretation on this rejection), the patch being seated in register within the socket in the central housing member (Para 294; “the electronic system 100 of FIG. 1 with the attachable device 302 configured to be attached to or housed in a holding device 802. The patch portion is the attachable device 302, and the holding device is 802 contains the socket as shown in annotated figure 8) allows interoperability between the diagnostic component in the patch and at least one electronic component in the central housing member (Para 31," the patch portion 110 may include a passive RFID tag with a coil and the bracelet portion 100 may include a battery with a circuit for directing current flow such that when the coil and circuit are placed in close physical proximity, with EM coupling thereby provided between the two components, the circuit may induce a corresponding current flow in the coil of the RFID tag so that the RFID tag may thereby broadcast over short range its ID signal.” This is an example of the interoperability of the patch and the electronic component in the central housing member).
Adhikari does not disclose when the patch is applied to a skin surface of a user and the bracelet is positioned over the patch.
However, Cheung discloses a wearable sensor system (Abstract and Figure 3) and teaches when the patch is applied to a skin surface of a user (Figure 2 and 3, elements 10) and the bracelet is positioned over the patch (Figures 2 and 3, element 14; the band 14 is analogous to a bracelet).
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 the specific sensor holding as taught by Cheung, in the invention of Adhikari, in order to allow the sensors of the diagnostic patch to be held in place against the user’s skin (Cheung; Para 31).
Response to Arguments
Applicant's arguments filed 09/24/2025 have been fully considered but they moot because of the new grounds of rejection.
Refer to 112 (a) rejection above for the written description rejection to claims 1, 22, and 25.
Examiner understands the argument being made against reference Kurzweil but respectfully disagrees. Please refer to Annotated Figure 11 in the rejection above. Patch portion 150/158 contains a dome 158 that includes diagnostic components 156, the band 20 contains the central housing that contains a socket, this socket contains a dimplet (element 160) that engages the patch device through recess 152. Figure 11 makes it very clear that the two components attach to one another. Examiner also suggests referring to Col. 10, lines 8-17 that clearly discloses how the patch portion 150 engages the band portion 10. Col. 10, lines 1-7 also disclose how element 158 is meant to be in contact with the skin. Lastly refer to Col. 10, lines 38-42 that shows how this sensor system provides a good hold against the skin for extended periods of time using a harness that is comfortable. Therefore, the examiner believes there is enough motivation to use this reference and therefore holds the rejection.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Carl Layno can be reached on (571) 272-4949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AYA ZIAD BAKKAR/
Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796