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 Objections
Claims 1, 20, 27, and 28 are objected to because of the following informalities: claims 1 and 20 recite “for driving the drug” this should be “for driving a drug.” Claim 27 depends on canceled claim 23. Claim 28 recites “a drug” this should be “the drug.” Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 27 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. 5. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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, 6-8, 12, 15-19, 21, 38, and 39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rogers et al. (US 2013/0041235 A1) in view of Durand (US 2009/0149800 A1), Rogers et al. (US 2013/0140649 A1), Rogers et al. (WO 2014/124049), and Ghaffari et al. (US 2012/0244848).
With regard to claims 1 and 7, Rogers et al. ‘235 teach a wearable medical device, comprising: a first elastically stretchable substrate that is removably attachable to an epidermis of a user by van der Waals forces alone ([0039], [0524], exemplary Fig. 26B substrate 110); at least one biosensor located on the substrate for measuring at least one physiological parameter or vital sign of the user while the substrate is attached to the user exemplary (Fig. 26B 120, [0039], [0235], [0331]-[0332]); at least one actuator located on the substrate for delivering at least one action to the user while the substrate is attached to the user ([0039], [0236], [0237]); a controller located on the substrate, the controller being operatively associated with the at least one biosensor and the at least one actuator such that the at least one actuator, responsive to a control signal received from the controller, delivers at least one action to the user based at least in part data received by the controller from the at least one biosensor ([0039], [0082], the controller can operate in a closed-loop using feedback, exemplary Fig. 26B 155, [0332], [0083] discloses the controller may be administered to the tissue site along with the flexible/stretchable circuit); and electrical interconnects electrically interconnecting the at least one biosensor and the at least one actuator, the electrical interconnects each having a serpentine configuration ([0019], [0023], [0104] the sensors and actuators are connected with a serpentine interconnect, exemplary Fig. 33a).
Rogers et al. ‘235 teach the actuator may be electrodes which apply current and voltage ([0236]) but do not explicitly disclose two electrodes for driving the drug into the skin with a charged drug hydrogel or solution. However, Durand teaches using a flexible patch with two electrodes and a charged gel to delivery an agent which is beneficial for delivery in that it minimizes tissue trauma, is relatively pain-free, and may be delivered directly to a treatment site ([0004], [0005], [0052]). Durand teaches feedback from sensors is used to control driving the substance into the patient ([0073]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use electrodes and a charged drug solution in Rogers et al. ‘235 as Rogers et al. ‘235 teach using electrodes and Durand teaches such a configuration is beneficial for delivery in that it minimizes tissue trauma, is relatively pain-free, and may be delivered directly to a treatment site.
Rogers et al. ‘235 disclose that the controller may be administered to the tissue site with the flexible circuit but do not explicitly disclose that the controller would be connected via the serpentine electrical interconnects. However, Rogers et al. ‘649 discloses a similar patch in which the microprocessor which contains software for executing instructions for use based on feedback signals can be incorporated with the actuation components ([0026], [0028], [0030]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to connect the controller into the substrate via the serpentine interconnects as Rogers et al. ‘235 teach providing the controller with the flexible circuit and Rogers et al. ‘649 teach incorporating the control components with the actuator and Rogers et al. ‘235 teach interconnecting actuation components into the array with the serpentine electrical connects which is beneficial in that it allows the device to be self-contained.
If Rogers et al. ‘235 is not found to disclose the controller chip on the substrate Rogers et al. ‘049 teach a similar patch in which electrical interconnects of different components can be connected to the microcontroller via releasable interconnects (Fig. 41 the releasable and changeable connector, Fig. 79 the indicated releasable connector) and Rogers et al. ‘049 also shows various controllers chips on the substrate (see the disclosure to chips on the substrate in at least [025] [0285], see also Fig. 52, Fig. 64, Fig. 66 showing chips encapsulated on the substrate, [0178] discloses microprocessors and control elements may be interconnected on the substrate). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a controller chip mounted on the substrate in Rogers et al. ‘235 as Rogers ‘049 teach such to be an art effective suitable placement of the controller for treatment and one of ordinary skill in the art would recognize the benefit of having a releasable connection which would allow for easier connection and removal. Rogers et al. ‘235 teach various electrical components may be flexible/stretchable which aids in the device conforming to the patient (abstract, [0009], [0015], [0019], [0027], [0039]) but the plurality of Rogers references do not explicitly disclose that the microcontroller is stretchable. However, Ghaffari et al. teach flexible and stretchable controller components which are beneficial so that the integrated electronics are movable to remain operational despite flexing and stretching ([0009], [0016], [0041], [0057]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use stretchable microcontroller circuit components in Rogers’235 as Ghaffari et al. teach this is beneficial to allow the device to remain operational during flexing and stretching and Rogers ‘235 has taught the benefits of using a stretchable and flexible electronic patch with flexible electronic components so that the device may conform to the skin. Given the teachings of Rogers ‘235 in combination with the other references one of ordinary skill would reasonably look to maximize the number of flexible electronic components to maximize the ability of the patch to deform with the skin.
With regard to claim 6, see at least [0042], [0050].
With regard to claim 8, see at least [0235].
With regard to claim 12, see at least [0015], [0034], and [0235].
With regard to claims 15, 17, and 38, see at least [0039] the sensors and actuators can be provided in an array, see at least Figs. 26B showing the array encapsulated in 130 which is taken as a second substrate which would be capable of removal from the first substrate ([0333]). Further see Figs. 29 and 41 showing how layered substrates with electrical components may be used, such layers are capable of removal.
With regard to claims 16, 18, and 39, see at least [0065], [0087], [0231], and [0234] regarding the contact pad.
With regard to claim 21, as combined see [0091] of Durand, additional electrodes may be provided.
With regard to claim 19, see at least [0254], [0447].
Claim(s) 9 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rogers et al. (US 2013/0041235 A1), Durand (US 2009/0149800 A1), Rogers et al. (US 2013/0140649 A1), Rogers et al. (WO 2014/124049), and Ghaffari et al. (US 2012/0244848) as applied to claim 1 above, and further in view of Avrahami et al. (US 6,597,946) and Li et al. (US 2013/0243655 A1)
With regard to claims 9 and 10, Rogers et al. ‘235 teach using passivation ([0289]. [0330]) but do not explicitly disclose a microfluidic layer for sampling. However, Avrahami et al. teach a transdermal delivery which also collects samples for testing (Col. 7 lines 34-44, Col. 25 lines 25-40). Further, Li et al. teach using microfluidic channels for sampling which enhance biosensing capabilities on wearable devices by being low cost, flexible, and allowing easier collection ([0004], [0005], [0041], [0050]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a microfluidc layer for sampling and sensing in Rogers et al. ‘235 as Avrahami et al. teach collecting samples tor adjusting treatment in a transdermal delivery device and Li et al. teach microfluidics to be beneficial for cost and ease.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rogers et al. (US 2013/0041235 A1), Durand (US 2009/0149800 A1), Rogers et al. (US 2013/0140649 A1), Rogers et al. (WO 2014/124049), and Ghaffari et al. (US 2012/0244848) as applied to claim 8 above, and further in view of Taylor et al. (US 2016/0030683 A1).
With regard to claim 11, Rogers et al. ‘235 teach spectroscopy ([0611]) but do not explicitly disclose electrochemical impedance spectroscopy. However, Taylor et al. teach using impedance spectroscopy to determine fluid characteristics as equivalent to other electrical, optical, mechanical, thermal, and/or rheological sensing ([0052], [0058], [0080]-[0084]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use electrochemical impedance spectroscopy in Rogers et al. ‘235 as Rogers et al. ‘235 teach using spectroscopy and Taylor et al. teach such is a known art effective means for sensing and would yield the same predictable result.
Claim(s) 20, 27-30, 34-37, and 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rogers et al. (US 2013/0041235 A1) in view of Rogers et al. (WO 2014/124049), Ghaffari et al. (US 2012/0244848), and Durand (US 2009/0149800 A1).
With regard to claims 20, 27, and 29, Rogers et al. teach a wearable medical device, comprising: a first elastically stretchable substrate that is removably attachable to an epidermis of a user by van der Waals forces alone ([0039], [0524], exemplary Fig. 26B substrate 110); at least one biosensor located on the substrate for measuring at least one physiological parameter or vital sign of the user while the substrate is attached to the user (Fig. 26B 120, [0039], [0235], [0331]-[0332]); at least one actuator located on the substrate for delivering at least one action to the user while the substrate is attached to the user ([0039], [0236], [0237]); and a controller located on the substrate, the controller being operatively associated with the at least one biosensor and the at least one actuator such that the at least one actuator, responsive to a control signal received from the controller, delivers at least one action to the user based at least in part data received by the controller from the at least one biosensor ([0039], [0082], the controller can operate in a closed-loop using feedback, exemplary Fig. 26B 155, [0332], [0083] discloses the controller may be administered to the tissue site along with the flexible/stretchable circuit).
Rogers et al. ‘235 teach the actuator may be electrodes which apply current and voltage ([0236]) but do not explicitly disclose two electrodes for driving the drug into the skin with a charged drug hydrogel or solution. However, Durand teaches using a flexible patch with two electrodes and a charged gel to delivery an agent which is beneficial for delivery in that it minimizes tissue trauma, is relatively pain-free, and may be delivered directly to a treatment site ([0004], [0005], [0052]). Durand teaches feedback from sensors is used to control driving the substance into the patient ([0073]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use electrodes and a charged drug solution in Rogers et al. ‘235 as Rogers et al. ‘235 teach using electrodes and Durand teaches such a configuration is beneficial for delivery in that it minimizes tissue trauma, is relatively pain-free, and may be delivered directly to a treatment site.
If Rogers et al. ‘235 is not found to disclose the controller chip on the substrate Rogers et al. ‘049 teach a similar patch in which electrical interconnects of different components can be connected to the microcontroller via releasable interconnects (Fig. 41 the releasable and changeable connector, Fig. 79 the indicated releasable connector) and Rogers et al. ‘049 also shows various controllers chips on the substrate (see the disclosure to chips on the substrate in at least [025] [0285], see also Fig. 52, Fig. 64, Fig. 66 showing chips encapsulated on the substrate, [0178] discloses microprocessors and control elements may be interconnected on the substrate). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a controller chip mounted on the substrate in Rogers et al. ‘235 as Rogers ‘049 teach such to be an art effective suitable placement of the controller for treatment and one of ordinary skill in the art would recognize the benefit of having a releasable connection which would allow for easier connection and removal. Rogers et al. ‘235 teach various electrical components may be flexible/stretchable which aids in the device conforming to the patient (abstract, [0009], [0015], [0019], [0027], [0039]) but the plurality of Rogers references do not explicitly disclose that the microcontroller is stretchable. However, Ghaffari et al. teach flexible and stretchable controller components which are beneficial so that the integrated electronics are movable to remain operational despite flexing and stretching ([0009], [0016], [0041], [0057]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use stretchable microcontroller circuit components in Rogers’235 as Ghaffari et al. teach this is beneficial to allow the device to remain operational during flexing and stretching and Rogers ‘235 has taught the benefits of using a stretchable and flexible electronic patch with flexible electronic components so that the device may conform to the skin. Given the teachings of Rogers ‘235 in combination with the other references one of ordinary skill would reasonably look to maximize the number of flexible electronic components to maximize the ability of the patch to deform with the skin.
With regard to claim 28, see at least [0042], [0050].
With regard to claim 30, see at least [0235].
With regard to claim 34, see at least [0015], [0034], and [0235].
With regard to claim 35, Rogers et al. ‘235 teaches serpentine interconnects [0019], [0023], [0104]. However, if these are not found to be self-similar serpentine interconnects, Rogers et al. ‘049 specifically teaches using self-similar serpentine interconnects which are beneficial for their geometry and buckling physics of ordered unraveling which provide a high device performance (Fig. 1C, [0222]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a self-similar serpentine configuration in Rogers et al. ‘235 as Rogers et al. ‘049 teach this is beneficial for device performance.
With regard to claim 36, see at least [0039] the sensors and actuators can be provided in an array, see at least Figs. 26B showing the array encapsulated in 130 which is taken as a second substrate which would be capable of removal from the first substrate ([0333]). Further see Figs. 29 and 41 showing how layered substrates with electrical components may be used, such layers are capable of removal.
With regard to claim 37, see at least [0065], [0087], [0231], and [0234] regarding the contact pad.
With regard to claim 40, see at least [0254], [0447].
Claim(s) 31 and 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rogers et al. (US 2013/0041235 A1), Rogers et al. (WO 2014/124049), Ghaffari et al. (US 2012/0244848), and Durand (US 2009/0149800 A1) as applied to claim 28 above, and further in view of Avrahami et al. (US 6,597,946) and Li et al. (US 2013/0243655 A1)
With regard to claims 31 and 32, Rogers et al. ‘235 teach using passivation ([0289]. [0330]) but do not explicitly disclose a microfluidic layer for sampling. However, Avrahami et al. teach a transdermal delivery which also collects samples for testing (Col. 7 lines 34-44, Col. 25 lines 25-40). Further, Li et al. teach using microfluidic channels for sampling which enhance biosensing capabilities on wearable devices by being low cost, flexible, and allowing easier collection ([0004], [0005], [0041], [0050]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a microfluidic layer for sampling and sensing in Rogers et al. ‘235 as Avrahami et al. teach collecting samples tor adjusting treatment in a transdermal delivery device and Li et al. teach microfluidics to be beneficial for cost and ease.
Claim(s) 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rogers et al. (US 2013/0041235 A1), Rogers et al. (WO 2014/124049), Ghaffari et al. (US 2012/0244848), and Durand (US 2009/0149800 A1) as applied to claim 30 above, and further in view of Taylor et al. (US 2016/0030683 A1).
With regard to claim 33, Rogers et al. ‘235 teach spectroscopy ([0611]) but do not explicitly disclose electrochemical impedance spectroscopy. However, Taylor et al. teach using impedance spectroscopy to determine fluid characteristics as equivalent to other electrical, optical, mechanical, thermal, and/or rheological sensing ([0052], [0058], [0080]-[0084]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use electrochemical impedance spectroscopy in Rogers et al. ‘235 as Rogers et al. ‘235 teach using spectroscopy and Taylor et al. teach such is a known art effective means for sensing and would yield the same predictable result.
Claim(s) 1, 6-8, 12-21, 27039, 34, and 36-40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Durand (US 2009/0149800 A1) in view of Rogers et al. (US 2013/0041235 A1), and Ghaffari et al. (US 2012/0244848).
With regard to claims 1 and 7, Durand teaches a wearable medical device, comprising: a first substrate that is removably attachable to an epidermis of a user (Fig. 2 28 and 26); at least one biosensor located on the substrate for measuring at least one physiological parameter or vital sign of the user while the substrate is attached to the user (Fig. 3 37, [0073]); at least one actuator located on the substrate for delivering at least one action to the user while the substrate is attached to the user, wherein the at least one actuator includes a transdermal drug delivery system (TDDS) having at least two electrodes for driving the drug into skin (Fig. 1 20 and 22); an on-board controller (Fig. 3 member 12) integrated with the at least one biosensor and the at least one actuator on the substrate, the controller being operatively associated with the at least one biosensor and the at least one actuator such that the at least one actuator, responsive to a control signal received from the controller, drives the drug into skin delivers at least one action to the user based at least in part on data received by the controller from the at least one biosensor ([0073]); and electrical interconnects electrically interconnecting the at least one biosensor, the at least one actuator and the controller (Fig. 3 wirings 18). Durand teaches a flexible substrate adhesively attached ([0008]) but do not disclose using van der Waals forces alone. However, Rogers et al. teach attaching an electrical treatment patch using van der Waals forces alone which is beneficial as adhesive or hardware is not necessary and allow the skin to deform freely and reversibly ([0524]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use van der Waals forces alone in Durand as Rogers et al. teach this is beneficial for the skin. Durand do not explicitly disclose that the microcontroller is stretchable. However, Rogers et al. teach various electrical components may be flexible/stretchable which aids in the device conforming to the patient (abstract, [0009], [0015], [0019], [0027], [0039]). Further, Ghaffari et al. teach flexible and stretchable controller components which are beneficial so that the integrated electronics are movable to remain operational despite flexing and stretching ([0009], [0016], [0041], [0057]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use stretchable microcontroller circuit components in Durand as Ghaffari et al. teach this is beneficial to allow the device to remain operational during flexing and stretching and Rogers et al. has taught the benefits of using a stretchable and flexible electronic patch with flexible electronic components so that the device may conform to the skin. Durand shows curved interconnects but does not explicitly disclose they are serpentine. Rogers et al. teaches using curved, serpentine, bent, wavy, or buckled circuit components which contribute to the flexible and stretchable nature of the circuit ([0019]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use serpentine interconnects in Durand as Rogers et al. teach these to be an art effective equivalent and provide flexibility and stretchability.
With regard to claim 6, see at least [0042], [0050].
With regard to claims 8 and 12, see [0015].
With regard to claims 15-18, Durand teaches the substrate has two layers 26 and 28, when attached the electronics are provided to both substates which are removably attachable to each other. Durand teaches a plurality of sensors are provided ([0012]) which would provide an array. Durand teaches a plurality of actuators ([0091], additional electrodes may be provided). As previously discussed, Durand and Rogers et al. show the interconnects. If the electronics of Durand were not found to teach a contact pad, Rogers et al. teach a contact pad to provide an electrical interface ([0065], [0087], [0231], and [0234]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a contact pad as Rogers et al. teach this is an art effective electrical interface.
With regard to claim 19, see at least [0254] and [0447] of Rogers et al.
With regard to claim 21, see [0091], additional electrodes may be provided.
With regard to claims 20, 27, and 29, Durand teaches a wearable medical device, comprising: a first substrate that is removably attachable to an epidermis of a user (Fig. 2 28 and 26); at least one biosensor located on the substrate for measuring at least one physiological parameter or vital sign of the user while the substrate is attached to the user (Fig. 3 37, [0073]); at least one actuator located on the substrate for delivering at least one action to the user while the substrate is attached to the user, wherein the at least one actuator includes a transdermal drug delivery system (TDDS) having at least two electrodes for driving the drug into skin (Fig. 1 20 and 22); an on-board controller (Fig. 3 member 12) integrated with the at least one biosensor and the at least one actuator on the substrate, the controller being operatively associated with the at least one biosensor and the at least one actuator such that the at least one actuator, responsive to a control signal received from the controller, drives the drug into skin delivers at least one action to the user based at least in part on data received by the controller from the at least one biosensor ([0073]). Durand teaches a flexible substrate adhesively attached ([0008]) but do not disclose using van der Waals forces alone. However, Rogers et al. teach attaching an electrical treatment patch using van der Waals forces alone which is beneficial as adhesive or hardware is not necessary and allow the skin to deform freely and reversibly ([0524]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use van der Waals forces alone in Durand as Rogers et al. teach this is beneficial for the skin. Durand do not explicitly disclose that the microcontroller is stretchable. However, Rogers et al. teach various electrical components may be flexible/stretchable which aids in the device conforming to the patient (abstract, [0009], [0015], [0019], [0027], [0039]). Further, Ghaffari et al. teach flexible and stretchable controller components which are beneficial so that the integrated electronics are movable to remain operational despite flexing and stretching ([0009], [0016], [0041], [0057]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use stretchable microcontroller circuit components in Durand as Ghaffari et al. teach this is beneficial to allow the device to remain operational during flexing and stretching and Rogers et al. has taught the benefits of using a stretchable and flexible electronic patch with flexible electronic components so that the device may conform to the skin.
With regard to claim 28, see at least [0042], [0050].
With regard to claims 30 and 34, see [0015].
With regard to claims 36-39, Durand teaches the substrate has two layers 26 and 28, when attached the electronics are provided to both substates which are removably attachable to each other. Durand teaches a plurality of sensors are provided ([0012]) which would provide an array. Durand teaches a plurality of actuators ([0091], additional electrodes may be provided). As previously discussed, Durand and Rogers et al. show the interconnects. If the electronics of Durand were not found to teach a contact pad, Rogers et al. teach a contact pad to provide an electrical interface ([0065], [0087], [0231], and [0234]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a contact pad as Rogers et al. teach this is an art effective electrical interface.
With regard to claim 40, see at least [0254] and [0447] of Rogers et al.
Claim(s) 9, 10, 31, and 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Durand (US 2009/0149800 A1), Rogers et al. (US 2013/0041235 A1), and Ghaffari et al. (US 2012/0244848) as applied to claims 1 and 20 above, and further in view of Avrahami et al. (US 6,597,946) and Li et al. (US 2013/0243655 A1)
With regard to claims 9, 10, 31, and 32, Rogers et al. ‘235 teach using passivation ([0289]. [0330]) but do not explicitly disclose a microfluidic layer for sampling. However, Avrahami et al. teach a transdermal delivery which also collects samples for testing (Col. 7 lines 34-44, Col. 25 lines 25-40). Further, Li et al. teach using microfluidic channels for sampling which enhance biosensing capabilities on wearable devices by being low cost, flexible, and allowing easier collection ([0004], [0005], [0041], [0050]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a microfluidc layer for sampling and sensing in Rogers et al. ‘235 as Avrahami et al. teach collecting samples tor adjusting treatment in a transdermal delivery device and Li et al. teach microfluidics to be beneficial for cost and ease.
Claim(s) 11 and 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Durand (US 2009/0149800 A1), Rogers et al. (US 2013/0041235 A1), and Ghaffari et al. (US 2012/0244848) as applied to claims 8 and 30 above, and further in view of Taylor et al. (US 2016/0030683 A1).
With regard to claims 11 and 33, Rogers et al. ‘235 teach spectroscopy ([0611]) but do not explicitly disclose electrochemical impedance spectroscopy. However, Taylor et al. teach using impedance spectroscopy to determine fluid characteristics as equivalent to other electrical, optical, mechanical, thermal, and/or rheological sensing ([0052], [0058], [0080]-[0084]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use electrochemical impedance spectroscopy in Rogers et al. ‘235 as Rogers et al. ‘235 teach using spectroscopy and Taylor et al. teach such is a known art effective means for sensing and would yield the same predictable result.
Claim(s) 16, 18, 35, 37, and 39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Durand (US 2009/0149800 A1), Rogers et al. (US 2013/0041235 A1), and Ghaffari et al. (US 2012/0244848) as applied to claims 15, 17, 20, 36, and 38 above, and further in view of Rogers et al. (WO 2014/124049).
With regard to claim 16, 18, 35, 37, and 39, as combined and discussed above Rogers et al. ‘235 teaches serpentine interconnects [0019], [0023], [0104] as well as the cited contact pads. However, if these are not found to be self-similar serpentine interconnects, Rogers et al. ‘049 specifically teaches using self-similar serpentine interconnects which are beneficial for their geometry and buckling physics of ordered unraveling which provide a high device performance (Fig. 1C, [0222]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a self-similar serpentine configuration in Durand as Rogers et al. ‘049 teach this is beneficial for device performance.
Response to Arguments
Applicant’s arguments with respect to the claim(s) 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. Applicant argues Rogers teaches away from incorporating a charged drug gel. Applicant has not provided any specific citations to Rogers which illustrate a teaching away. Applicant notes certain factors which Rogers emphasizes (with no citations). Applicant notes dry epidermal contact, the device being thin, protected electronics, and mechanical compliance. Rogers teaches the device may be used with a therapeutic agent ([0098]), discusses how the device is protected from fluid ([0239]), discusses fluid communication ([0247]), as such it appears the device would be operable in the presence of such a therapeutic agent. In Durand the electronics are sealed (see at least [0048]) and compatible for use with the agent, the device is also thin and flexible which does not appear to take away from the capabilities of Rogers. It does not appear that the combination would take away from of these features. Applicant cites Durand does not disclose stretching, van der Waals attachment, or serpentine interconnects. It is not relied upon to teach these features. Regarding the new limitations, Applicant argues Durand does not teach closed loop control or biosensors, as cited above Durand does teach using feedback from biosensors to control delivery. As Rogers teaches electrical activation of an agent ([0098]) the Examiner finds the benefits of Durand’s iontophoretic delivery are applicable. Applicant argues the combination would require extensive redesign. As Durand also teaches a thin patch with electronics for delivery, the Examiner finds one or ordinary skill would be able to incorporate teachings of both references as they are both thin, flexible, electrical patches providing treatment. An additional rejection has also been made in light of the new limitations.
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 EMILY L SCHMIDT whose telephone number is (571)270-3648. The examiner can normally be reached Monday through Thursday 7:00 AM to 4:30 PM.
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/EMILY L SCHMIDT/Primary Examiner, Art Unit 3783