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
Claim 2 is objected to because of the following informalities: Claim 2 states “to treat tremor”. This should be “tremors” or “a tremor”. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: The phrase “online portal configured to provide information with the therapy unit” seems as if it should be “online portal configured to provide information to the therapy unit”. 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 § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 2, 6, and 11-13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gozani et al. (Pub. No.: US 2013/0158627 A1); hereinafter referred to as “Gozani”.
Regarding claim 2, Gozani discloses a system (e.g. see figure 1 element 100, [0064]) for stimulating at least one nerve of a user to treat tremor (e.g. see figure 1 element 100, [0064]. Note: This is an intended use limitation of a system claim and adds no structure), the system comprising: a skin interface (e.g. see figure 1 element 110, [0064]) comprising: a first surface (e.g. see figure 6 element 214, [0074]) configured to contact skin of the user, the first surface comprising at least two skin electrodes (e.g. see figure 6 elements 202, 204, 206, 208, [0074]), at least two electrical contacts (e.g. see figure 6 elements 210, 212, [0074]), and an electrical circuit (e.g. see figure 6 elements 205, 207, [0074]) configured to be in electrical communication with the at least two skin electrodes and the at least two electrical contacts; and a therapy unit (e.g. see figure 1 elements 101, 102, 103, [0065]) comprising: a stimulator (e.g. see figure 1 element 105, [0065]) configured to generate an electrical stimulation; 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, the at least two electrical contacts of the therapy unit configured to connect to the at least two electrical contacts of the skin interface, thereby forming an electrical connection between the stimulator and the at least two skin electrodes (e.g. see [0066], “electro-mechanical connection”); a controller (e.g. see figure 1 element 106, [0068], “stimulator 105 includes a push button 106 for control of electrical stimulation”, [0069], “These remote user interface elements may be located on dedicated devices specifically designed to control stimulator 105”. Note: Right now, the examiner is interpreting element 106 as the “controller”. However, the remote control in [0069] is being made part of the record as well) configured to control generation of the electrical stimulation by the stimulator; and a power source (e.g. see [0067], “battery contained in one of the outboard compartments 101, 103”) in electrical communication with the electrical circuit.
Regarding claim 6, Gozani discloses the at least two skin 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 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)”).
Regarding claim 12, Gozani discloses the at least two electrical contacts of the therapy unit comprise at least one of a pin and a pin hole (e.g. see figure 2 elements 210, 212, 130, 132. The examiner is interpreting 210, 212 as the pin and 130, 132 as the pin hole).
Regarding claim 13, Gozani discloses the controller is configured to control generation of the electrical stimulation by the stimulator based on data measured by one or more sensors of the therapy unit (e.g. see [0068], “Additional uses for the accelerometer include the detection of certain movement characteristics of TENS apparatus 100, and therefore identification of patient orientation and activity, such as lying, standing, walking, gait, etc., which permits modifying the stimulation characteristics of stimulator 105 in order to optimize stimulation for the identified patient state”).
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) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gozani in view of in view of Giuntoli et al. (Pub. No.: 2003/0004555 A1); hereinafter referred to as “Giuntoli”.
Regarding claim 3, Gozani discloses the invention but is silent as to at least one skin electrode of the at least two skin electrodes is positioned on the first 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.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gozani in view of Williams et al. (Pub. No.: US 2013/0231725 A1); hereinafter referred to as “Williams”.
Regarding claim 4, Gozani discloses a device for transcutaneously stimulating nerves (e.g. see figure 1 element 100, [0064], “TENS apparatus”) but is silent as to the at least two skin electrodes are positioned on the first surface to stimulate at least two of: a radial nerve, an ulnar nerve, or a median nerve. Williams teaches it is known to use such a modification as set forth in the abstract and [0015]-[0017] to provide therapeutic stimulation of the afferent nerves of the hand and arm (e.g. see [0018]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use stimulation of the radial nerve, an ulnar nerve, or a median nerve as taught by Williams in the system/method of Gozani, since said modification would provide the predictable results of therapeutic stimulation of the afferent nerves of the hand and arm.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gozani in view of Gozani et al. (Pub. No.: US 2014/0296934 A1); hereinafter referred to as “Gozani 934”.
Regarding claims 5, Gozani discloses the claimed invention but is silent as to the at least two skin electrodes comprise dry electrodes. Gozani 934 teaches that it is known to use such a modification as set forth in [0041] to provide additional types of electrodes that are contemplated and within the scope of the invention (e.g. see [0041]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use dry electrodes as taught by Gozani 934 in the system/method of Gozani, since said modification would provide the predictable results of additional types of electrodes that are contemplated and within the scope of the invention.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gozani in view of Dunbar et al. (Pub No.: US 2014/0207219 A1); hereinafter referred to as “Dunbar”.
Regarding claim 7, Gozani 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, since said modification would provide the predictable results of a more user-friendly charging interface.
Claim(s) 8-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gozani in view of Asseo et al. (Pub No.: US 2016/0096027 A1); hereinafter referred to as “Asseo”.
Regarding claims 8 and 9, Gozano discloses the claimed invention except for the therapy unit is further configured to transmit data to a cloud computing network and online portal configured to provide information with the therapy unit. Asseo teaches it is known to use such a modification as set forth in [0033]-[0037] to provide a cloud server that can propose new treatment plans having modified electrical profiles (e.g. see [0037]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use a cloud computing network as taught by Asseo in the system/method of Gozani, since said modification would provide the predictable results of a cloud server that can propose new treatment plans having modified electrical profiles (e.g. see [0037]).
Regarding claim 10, Gozano discloses the claimed invention except for a portable computing device with a user interface and a display, wherein the portable computing device is configured to wirelessly communicate with the therapy unit. Asseo teaches it is known to use such a modification as set forth in figures 1A-1C, element 134, [0020]-[0024] to provide tens treatment information via a user interface (phone) that is already carried by the patient. It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use a portable computing device as taught by Asseo in the system/method of Gozani, since said modification would provide the predictable results of tens treatment information via a user interface (phone) that is already carried by the patient.
Claim(s) 14, 15, 18, 19, and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gozani in view of Carroll et al. (Pub. No.: US 2014/0236258 A1); hereinafter referred to as “Carroll”.
Regarding claim 14, Gozani discloses the system (see the rejection for claim 2 above) but is silent as to the skin interface further comprises a receptacle for reversibly securing the detachable 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, since said modification would provide the predictable results of a pocket to greater secure and obscure the detachable stimulation device.
Regarding claim 15, Gozani discloses the invention but is silent as to a second detachable therapy unit, the second detachable 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 detachable therapy unit is 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, since said modification would provide the predictable results of coverage of different treatment zones.
Regarding claim 18, 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 19, Gozani discloses the at least two electrical contacts of the detachable therapy unit comprise at least one of a pin and a pin hole (e.g. see figure 2 elements 210, 212, 130, 132. The examiner is interpreting 210, 212 as the pin and 130, 132 as the pin hole).
Regarding claim 21, Gozani discloses the invention but is silent as to 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. Carroll teaches that it is known to use such a modification as set forth in figures 6 and 7, elements 100, 300, 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.
Claim(s) 16 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gozani and Carroll as applied to claims 14 and 15 above, and further in view of Williams.
Regarding claim 16, Gozani discloses the invention but is silent as to a second skin interface comprising at least two second transcutaneous electrodes. Carroll teaches that it is known to use such a modification as set forth in figure 6, elements 600, 602, [0038] 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, since said modification would provide the predictable results of coverage of different treatment zones.
Gozani and Carroll discloses the claimed invention but are silent as to the electrodes configured to stimulate at least one of: a radial nerve, an ulnar nerve, or the median nerve. Williams teaches it is known to use such a modification as set forth in the abstract and [0015]-[0017] to provide therapeutic stimulation of the afferent nerves of the hand and arm (e.g. see [0018]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use stimulation of the radial nerve, an ulnar nerve, or a median nerve as taught by Williams in the system/method of Gozani and Carroll, since said modification would provide the predictable results of therapeutic stimulation of the afferent nerves of the hand and arm.
Regarding claim 20, Gozani and Carroll discloses the claimed invention but are silent as to a second one of the at least two transcutaneous electrodes is configured to be positioned to stimulate a radial nerve. Williams teaches it is known to use such a modification as set forth in the abstract and [0015]-[0017] to provide therapeutic stimulation of the afferent nerves of the hand and arm (e.g. see [0018]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use stimulation of the radial nerve as taught by Williams in the system/method of Gozani and Carroll, since said modification would provide the predictable results of therapeutic stimulation of the afferent nerves of the hand and arm.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gozani and Carroll as applied to claims 14 above, and further in view of Gozani 934.
Regarding claims 17, Gozani discloses the claimed invention but is silent as to the at least two transcutaneous electrodes comprise dry electrodes. Gozani 934 teaches that it is known to use such a modification as set forth in [0041] to provide additional types of electrodes that are contemplated and within the scope of the invention (e.g. see [0041]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use dry electrodes as taught by Gozani 934 in the system/method of Gozani, since said modification would provide the predictable results of additional types of electrodes that are contemplated and within the scope of the invention.
Conclusion
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/P.C.E/Examiner, Art Unit 3792
/AMANDA L STEINBERG/Examiner, Art Unit 3792
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