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 5 and 18 is objected to because of the following informalities: Claims 5 and 18 state “one or more sensors configured to detect or measure tremor”. This should be “tremors” or “a tremor”. Appropriate correction is required.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 2-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 10,765,856 B2 and claims 1-20 of Patent No.: US 12,157,001 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the parent patents cited contain each and every limitation of the independent claims and thus anticipate the claims.
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) 2, 4-7, 9, and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gozani et al. (Pub. No.: US 2013/0158627 A1); hereinafter referred to as “Gozani”, in view of Giuntoli et al. (Pub. No.: 2003/0004555 A1); hereinafter referred to as “Giuntoli”, in view of Carroll et al. (Pub. No.: US 2014/0236258 A1); hereinafter referred to as “Carroll”.
Regarding claim 2, Gozani discloses a stimulation system (e.g. see figure 1 element 100, [0064]) comprising: a skin interface (e.g. see figure 1 element 110, [0064]) comprising: a skin facing surface (e.g. see figure 6 element 214, [0074]) configured to be in contact with skin of a user, at least two transcutaneous electrodes (e.g. see figure 6 elements 202, 204, 206, 208, [0074]) on the skin facing surface; at least two receiving contacts (e.g. see figure 6 elements 210, 212, [0074]) on a second surface of the skin interface opposite the skin facing surface; and an electrical circuit (e.g. see figure 6 elements 205, 207, [0074]) configured to electrically connect the at least two transcutaneous electrodes with the at least two receiving contacts; and a therapy unit (e.g. see figure 1 element 105, [0065]) comprising: a power source (e.g. see [0065], [0067], “battery contained in one of the outboard compartments 101, 103”); a stimulator (e.g. see figure 1 element 102, [0065]) powered by the power source, the stimulator configured to generate an electrical stimulation that is delivered through the at least two transcutaneous electrodes of the skin interface (e.g. see [0072]); and at least two electrical contacts (e.g. see figure 2 elements 130, 132, [0066]) configured to connect to the at least two receiving contacts of the skin interface.
Gozani discloses the invention but is silent as to at least one transcutaneous electrode of the at least two transcutaneous electrodes is positioned on the skin facing surface to stimulate a median nerve. Giuntoli teaches it is known to use such a modification as set forth in [0013], [0014], and [0016] to provide a device that fits comfortably on the wrist, allows free extension and flexion of the wrist, and concentrates stimulation over the P-6 acupuncture point (e.g. see [0014]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use electrodes positioned over the median nerve as taught by Giuntoli in the system/method of Gozani, since said modification would provide the predictable results of a device that fits comfortably on the wrist, allows free extension and flexion of the wrist, and concentrates stimulation over the P-6 acupuncture point.
Gozani and Giuntoli disclose the invention but are silent as to the skin interface comprises a receptacle for detachably securing the therapy unit to the skin interface. Carroll teaches that it is known to use such a modification as set forth in figures 1 and 3, element 116, [0031], [0034] to provide a pocket to greater secure and obscure the detachable stimulation device. It would have been obvious to one having ordinary skill in the art at the time the invention was made to use a receptacle/pocket as taught by Carroll in the system/method of Gozani and Giuntoli, since said modification would provide the predictable results of a pocket to greater secure and obscure the detachable stimulation device.
Regarding claim 4, Gozani discloses the at least two transcutaneous electrodes comprise a hydrogel (e.g. see [0074]. “The individual electrodes 202, 204, 206, 208 are preferably constructed from a hatched silver pattern overlaid with a conductive hydrogel”).
Regarding claim 5, Gozani discloses the therapy unit comprises one or more sensors configured to detect or measure tremor (e.g. see [0068]. Note: An accelerometer is configured to detect or measure a tremor).
Regarding claims 6 and 7, Gozani and Giuntoli disclose the invention but are silent as to the therapy unit is configured to communicate wirelessly with a monitoring unit to update parameters of the electrical stimulation and to receive data from the therapy unit, wherein the monitoring unit is a smartphone. Carroll teaches that it is known to use such a modification as set forth in figures 6 and 7, elements 600 and 602 to provide less physical product to track, produce, repair, or update, since the application can be implemented on hardware that the patient likely already has (e.g. see [0040]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use a portable computing device with a user interface and a display, wherein the portable computing device is configured to wirelessly communicate with the detachable therapy unit as taught by Carroll in the system/method of Gozani and Giuntoli, since said modification would provide the predictable results of less physical product to track, produce, repair, or update, since the application can be implemented on hardware that the patient likely already has.
Regarding claim 9, Gozani and Giuntoli disclose the invention but are silent as to a second therapy unit, the second therapy unit comprising: a second power source; and a second stimulator powered by the second power source, the second stimulator configured to generate an electrical stimulation that is delivered through the at least two transcutaneous electrodes of the skin interface, wherein the second therapy unit is removably attachable to the skin interface. Carroll teaches that it is known to use such a modification as set forth in figures 6 and 7, elements 100, 300, to provide coverage of different treatment zones (e.g. see [0038]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use multiple therapy units as taught by Carroll in the system/method of Gozani and Giuntoli, since said modification would provide the predictable results of coverage of different treatment zones.
Regarding claim 11, Gozani discloses the therapy unit further comprises a user interface (e.g. see [0069], “user interface elements (e.g., push button 106 and LEDs 108)”).
Claim(s) 3 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gozani, Giuntoli, and Carroll as applied to claims 2 and 5 above, and further in view of Rahimi et al. (Pub. No.: US 2014/0031895 A1); hereinafter referred to as “Rahimi”.
Regarding claim 3, Gozani, Giuntoli, and Carroll disclose the claimed invention but are silent as to the at least two transcutaneous electrodes comprise carbon. Rahimi teaches it is known to use such a modification as set forth in [0020] to provide an electrode that may be a composite of a variety of materials (e.g. see [0020]) based on the application. It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use carbon in the electrode as taught by Rahimi in the system/method of Gozani, Giuntoli, and Carroll, since said modification would provide the predictable results of an electrode that may be a composite of a variety of materials based on the application.
Regarding claim 8, Gozani, Giuntoli, and Carroll disclose the claimed invention but are silent as to the therapy unit is further configured to transmit data to a cloud computing network. Rahimi teaches it is known to use such a modification as set forth in [0056] to provide a network configured to transmit, store, and receive data (e.g. see [0056]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use the cloud for data storage and transmission as taught by Rahimi in the system/method of Gozani, Giuntoli, and Carroll, since said modification would provide the predictable results of a network configured to transmit, store, and receive data.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gozani, Giuntoli, and Carroll in view of Dunbar et al. (Pub No.: US 2014/0207219 A1); hereinafter referred to as “Dunbar”.
Regarding claim 10, Gozani, Giuntoli, and Carroll discloses charging the power source (e.g. see [0067]) but is silent as to a base station configured to charge the power source. Dunbar teaches it is known to use such a modification as set forth in [0038]-[0040] to provide a more user-friendly charging interface. It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use a base station configured to charge the power source as taught by Dunbar in the system/method of Gozani, Giuntoli, and Carroll, since said modification would provide the predictable results of a more user-friendly charging interface.
Claim(s) 12, 16, and 18-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gozani view of Carroll.
Regarding claim 12, Gozani discloses a stimulation system (e.g. see figure 1 element 100, [0064]) comprising:(i) a first unit (e.g. see figure 1 element 110, [0064]) comprising: a skin facing surface (e.g. see figure 6 element 214, [0074]) comprising at least two transcutaneous electrodes (e.g. see figure 6 elements 202, 204, 206, 208, [0074]); at least two receiving contacts (e.g. see figure 6 elements 210, 212, [0074]), and an electrical circuit (e.g. see figure 6 elements 205, 207, [0074]) in electrical communication with the at least two transcutaneous electrodes and the at least two receiving contacts (e.g. see [0066], “electro-mechanical connection”); and(ii) a second unit (e.g. see figure 1 element 105, [0065]) comprising: a stimulator (e.g. see figure 1 element 102, [0065]) configured to generate an electrical stimulation; and at least two electrical contacts (e.g. see figure 2 elements 130, 132, [0066]) that are configured to receive the electrical stimulation from the stimulator; and(iii) a power source (e.g. see [0065], [0067], “battery”) disposed within the first unit or the second unit.
Gozani discloses the invention but is silent as to a receptacle for reversibly securing the second unit to the first unit. Carroll teaches that it is known to use such a modification as set forth in figures 1 and 3, element 116, [0031], [0034] to provide a pocket to greater secure and obscure the detachable stimulation device. It would have been obvious to one having ordinary skill in the art at the time the invention was made to use a receptacle/pocket as taught by Carroll in the system/method of Gozani and Giuntoli, since said modification would provide the predictable results of a pocket to greater secure and obscure the detachable stimulation device.
Regarding claim 16, Gozani discloses the power source comprises a battery (e.g. see [0065], [0067], “battery”).
Regarding claim 18, Gozani discloses the second unit comprises one or more sensors configured to detect or measure tremor (e.g. see [0068]. Note: An accelerometer is configured to detect or measure a tremor).
Regarding claims 19 and 20, Gozani discloses the invention but are silent as to the second unit is configured to communicate wirelessly with a monitoring unit to update parameters of the electrical stimulation and to receive data from the second unit and the monitoring unit is a smartphone. Carroll teaches that it is known to use such a modification as set forth in figures 6 and 7, elements 600 and 602 to provide less physical product to track, produce, repair, or update, since the application can be implemented on hardware that the patient likely already has (e.g. see [0040]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use a portable computing device with a user interface and a display, wherein the portable computing device is configured to wirelessly communicate with the detachable therapy unit as taught by Carroll in the system/method of Gozani, since said modification would provide the predictable results of less physical product to track, produce, repair, or update, since the application can be implemented on hardware that the patient likely already has.
Regarding claim 21, Gozani discloses the second unit further comprises a user interface (e.g. see [0069], “user interface elements (e.g., push button 106 and LEDs 108)”).
Claim(s) 13 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gozani and Carroll as applied to claim 12 above, and further in view of Rahimi.
Regarding claim 13, Gozani and Carroll disclose the claimed invention but are silent as to the at least two transcutaneous electrodes comprise carbon. Rahimi teaches it is known to use such a modification as set forth in [0020] to provide an electrode that may be a composite of a variety of materials (e.g. see [0020]) based on the application. It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use carbon in the electrode as taught by Rahimi in the system/method of Gozani and Carroll, since said modification would provide the predictable results of an electrode that may be a composite of a variety of materials based on the application.
Regarding claim 17, Gozani and Carroll disclose the claimed invention but are silent as to the therapy unit is further configured to transmit data to a cloud computing network. Rahimi teaches it is known to use such a modification as set forth in [0056] to provide a network configured to transmit, store, and receive data (e.g. see [0056]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use the cloud for data storage and transmission as taught by Rahimi in the system/method of Gozani and Carroll, since said modification would provide the predictable results of a network configured to transmit, store, and receive data.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gozani and Carroll in view of Giuntoli.
Regarding claim 14, Gozani and Carroll disclose the invention but are silent as to the first unit comprises a wrist band. Giuntoli teaches it is known to use such a modification as set forth in figure 1, element 5 to provide a device that allows stimulation of the median nerve (e.g. see [0013], [0014], and [0016]. Note: Per claim 2 above, the median nerve is the target nerve of the applicant’s device). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use a wrist band with electrodes positioned over the median nerve as taught by Giuntoli in the system/method of Gozani and Carroll, since said modification would provide the predictable results of a device that allows stimulation of the median nerve.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gozani and Carroll in view of Dunbar.
Regarding claim 15, Gozani and Carroll disclose charging the power source (e.g. see [0067]) but is silent as to a base station configured to charge the power source. Dunbar teaches it is known to use such a modification as set forth in [0038]-[0040] to provide a more user-friendly charging interface. It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use a base station configured to charge the power source as taught by Dunbar in the system/method of Gozani and Carroll, since said modification would provide the predictable results of a more user-friendly charging interface.
Conclusion
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/P.C.E/Examiner, Art Unit 3792
/AMANDA L STEINBERG/Examiner, Art Unit 3792
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