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 .
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 1-26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 11,911,605 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because US 11,911,605 B2 has been found to anticipate each and every element of the present invention, for instance both provide an electrode carrier configured to place a set of electrodes into physical contact with the external part of the body of a patient, a stimulation module in electrical communication with the electrode carrier, the stimulation module including signal generation circuitry configured to generate an electrical stimulation signal as a direct current (DC) pulse at a frequency between 10 kHz and 50 kHz; and control circuitry configured to sequentially activate different subsets of electrodes in the set of electrodes, each of the different subsets including one or more electrodes of the set of electrodes activated as a signal source for the electrical stimulation signal and one or more electrodes of the set of electrodes activated as a signal sink for the electrical stimulation signal.
As set forth above, the present invention is not viewed to be patentably distinct from US 11,911,605 B2
Claims 1-26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,533,506 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because US 12,533,506 B2 has been found to anticipate each and every element of the present invention, for instance both provide an electrode carrier configured to place a set of electrodes into physical contact with the external part of the body of a patient, a stimulation module in electrical communication with the electrode carrier, the stimulation module including signal generation circuitry configured to generate an electrical stimulation signal as a direct current (DC) pulse at a frequency between 10 kHz and 50 kHz; and control circuitry configured to activate different subsets of electrodes in the set of electrodes, each of the different subsets including one or more electrodes of the set of electrodes activated as a signal source for the electrical stimulation signal and one or more electrodes of the set of electrodes activated as a signal sink for the electrical stimulation signal.
As set forth above, the present invention is not viewed to be patentably distinct from US 12,533,506 B2.
Claim Rejections - 35 USC § 103
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-25 are rejected under 35 U.S.C. 103 as being unpatentable over Rosenbluth et al. (US 2015/0321000 A1) in view of Page et al. (US 2017/0281941 A1).
Rosenbluth et al. discloses a system for therapeutic electrical stimulation of an arm or wrist (Figure 1; [0045]) with a flexible band configured to be secured around the arm or wrist of a patient ([0164-0165]), the flexible band supporting an electrode carrier ([0164-0166]) configured to place a set of electrodes ([0053-0054, 0173, 0197]) into physical contact with the arm or wrist ([0164-0166]), a stimulation module in electrical communication with the electrode carrier (Abstract, [0135, 0213]), the stimulation module including signal generation circuitry configured to generate an electrical stimulation signal as a direct current (DC) pulse ([0143]) and control circuitry configured to sequentially activate different subsets of electrodes in the set of electrodes ([0053, 0173]), each of the different subsets including one or more electrodes of the set of electrodes activated as a signal source for the electrical stimulation signal and one or more electrodes of the set of electrodes activated as a signal sink for the electrical stimulation signal ([0053, 0173, 0206]), the set of electrodes being spaced on the flexible band and configured to deliver electrical stimuli from the stimulation module to the arm or wrist for exciting a first nerve selected from the median, radial or ulnar nerve ([0137]), at least one of the electrodes in the set of electrodes being arranged on a dorsal side of the arm or wrist (Figures 14H-14L; [0166]), and at least one other of the electrodes in the set of electrodes being arranged on a ventral side of the arm or wrist (Figures 14H-14L; [0166]).
As to claim 1, Rosenbluth et al. discloses the invention substantially as claimed but does not explicitly disclose generating “an electrical stimulation signal as a direct current (DC) pulse at a frequency between 10 kHz and 50 kHz”. Page et al. discloses providing electrical stimulation signals at a frequency of 10kHz to 50kHz ([0004, 0056, 0065]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the frequency of the electrical stimulation signal of Rosenbluth et al. to include a frequency between 10 kHz and 50 kHz as disclosed by Page et al., since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233 (see MPEP 2144.05). Furthermore, such a modification would provide the predictable results of modifying the electrical stimulation signals to meet specific patient therapeutic needs and requirements.
As to claim 2, Rosenbluth et al., and thus the modified Rosenbluth et al., discloses the flexible band includes a third electrode in electrical communication with the signal generation circuitry (Figures 14H-14L), the first and third electrodes being spaced on the flexible band to deliver the electrical stimulation signal from the signal generation circuitry to the patient to excite a second nerve other than the first nerve ([0027-0032]), the second nerve being selected from the patient's median, radial or ulnar nerve ([0032]), the first and third electrodes being arranged and configured such that in a transverse cross-sectional plane of the arm or wrist there is a 90 degree to 180 degree angle between a line connecting the second nerve and the first electrode and a line connecting the second nerve and the third electrode (Figures 9A-9B and 14H-14L), wherein the first nerve and the second nerve are different nerves ([0032]), wherein the controller is further configured to deliver the electrical stimulation signal from the signal generation circuitry to the first electrode, to the second electrode, and to the third electrode ([0037,0048]).
Additionally, as to claim 2, the modified Rosenbluth et al. discloses the invention substantially as claimed but does not explicitly disclose the system further comprises a switch matrix configured to switch the signal generation circuitry between the first electrode and the second electrode. Switch matrixes are extremely well-known electrical components in electronics. It would have been obvious to one having ordinary skill in the art at the time the invention was made to incorporate a switch matrix into the circuitry in order to provide the predictable results of incorporating well-known circuitry components to enhancing device performance and function.
As to claim 3, Rosenbluth et al, and thus the modified Rosenbluth et al., discloses the control circuitry is configured to determine the defined activation sequence according to signaling received by the control circuitry, the signaling comprising any one of: a signal provided by or read from the electrode carrier, an input signal resulting from user control of a control input provided to the system, or an input signal received wirelessly from a configuration device that is communicatively coupled to the stimulation module (Figures 7A-7D; [0212]).
As to claim 4, Rosenbluth et al, and thus the modified Rosenbluth et al., discloses the electrode carrier includes a flexible sheet or membrane configured for conformable placement on the arm or wrist ([0077]), the flexible sheet or membrane carrying the set of electrodes on a surface of the flexible sheet or membrane which faces the arm or wrist (Figure 14I-14L; [0103, 0166]).
As to claim 5, Rosenbluth et al, and thus the modified Rosenbluth et al., discloses the flexible band includes the flexible sheet or membrane and a compressive sleeve that exerts a biasing force urging the set of electrodes into contact with the arm or wrist (Figure 14I-14L; [0103, 0166]), the biasing force being obtained via at least one of: elastic material incorporated into or about the compressive sleeve or one or more cinching straps incorporated into or about the sleeve (Figure 14I-14L; [0103, 0166]).
As to claim 6, Rosenbluth et al., and thus the modified Rosenbluth et al., discloses the signal generation circuitry is configured to control the frequency of the electrical stimulation signal responsive to control by the control circuitry, the control including one of: selection of a particular frequency from among a set of predefined frequencies or continuous adjustment of the frequency ([0206, 0213]).
As to claim 7, Rosenbluth et al, and thus the modified Rosenbluth et al., disclose the signal generation circuitry is configured to control an intensity of the electrical stimulation signal responsive to control by the control circuitry, the control including one of: adjustment of the voltage of the electrical stimulation signal ([0140]).
As to claim 8, Rosenbluth et al, and thus the modified Rosenbluth et al., disclose plus control configured to increase the intensity and coupled to the control circuitry, and a minus control configured to decrease the intensity and coupled to the control circuitry (Figures 13A-13B).
As to claim 9, Rosenbluth et al, and thus the modified Rosenbluth et al., disclose a housing that houses the stimulation module and is coupled to or integrated with the flexible band (Figures 14H-14L), at least a common electrode of the set of electrodes being disposed on the flexible band or the housing relative to an underside of the housing, the underside facing the arm or wrist of the patient, and wherein the housing, when coupled to the flexible band, includes a plurality of connectors to operatively and electrically couple the housing with the set of electrodes in the flexible band (Figures 14H-14L).
As to claim 10, Rosenbluth et al, and thus the modified Rosenbluth et al., disclose the housing including a display configured to display status information and a timer showing in real time an indication of a duration of time that the electrical stimuli have been delivered to the arm or wrist (wrist watch, [0103]; Figures 14H-14L), the display being further configured to display an indication of the intensity of the electrical stimuli being applied to the arm or wrist (Figures 14H-14L; [0128, 0191]).
As to claim 11, Rosenbluth et al, and thus the modified Rosenbluth et al., disclose the flexible band extends circumferentially around the arm or wrist and is configured to be secured thereto and have an adjustable diameter to accommodate a diameter of the arm or wrist to which the flexible band is secured (Figures 14H-14L; [0103]).
As to claim 12, the modified Rosenbluth et al. disclose at least one of the electrodes of the set of electrodes has a contact point with the arm or wrist with which the at least one electrode is in contact to provide localized delivery of the electrical stimuli at the contact point (Figures 14H-14L) but does not explicitly disclose “has a hemispherical contact point”. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the shape of the contact points from rectangular (as depicted in Figures 14H-14L) to hemispherical contact point, since it has been held that changes in shape was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration was significant. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). (see MPEP 2144.04) Furthermore, such a modification would provide the predictable results adapting the contact points geometry or shape to enhance patient comfort without sacrificing effectiveness.
As to claim 13, the modified Rosenbluth et al. as applied to claim 12 above, discloses each of at least two of the electrodes of the set of electrodes has a hemispherical contact point with the arm or wrist with which the respective one of the at least two electrodes is in contact (the modified Rosenbluth et al., Figures 14H-14L).
As to claim 14, the modified Rosenbluth et al. discloses at least one electrode of the set of electrodes has a flat surface (Figures 14H-14L), but does not explicitly discloses having a largest dimension not exceeding between 10 and 30 mm. It would have been obvious to one having ordinary skill in the art at the time the invention was made to have modified the size of the electrode, since it has been held that where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984.) See the MPEP 2144.04. Furthermore, such a modification would provide the predictable results of optimizing the electrode dimensions to meet specific patient therapeutic needs and requirements.
As to claim 15, Rosenbluth et al, and thus the modified Rosenbluth et al., disclose a multi-axis motion sensor ([0177]) on the arm or wrist or another arm or wrist of the patient, the control circuitry or a controller being configured to receive signals from the multi-axis motion sensor and determine therefrom a frequency of a tremor of the patient while the electrical stimuli is applied to the arm or wrist ([0177-0178]).
As to claim 16, Rosenbluth et al, and thus the modified Rosenbluth et al., discloses the control circuitry or the controller is further configured to monitor in real time the frequency of the tremor and change which subsets of electrodes are activated based on the monitored frequency ([0204-0207]; Figure 22), wherein the set of electrodes includes at least three electrodes or at least four electrodes or at least five electrodes or at least six electrodes (Figures 14H-14L; [0173]).
As to 17, the modified Rosenbluth et al. discloses the control circuitry or the controller is further configured to adjust the frequency of the electrical stimulation signal based on the monitored frequency of the tremor ([0204-0207]; Figure 22), wherein the adjusted frequency of the electrical stimulation signal is between 10 kHz and 50 kHz (the modified Rosenbluth et al., Page et al., [0004, 0056, 0065]).
As to claim 18, Rosenbluth et al., and thus the modified Rosenbluth et al., disclose monitoring tremor frequency and modifying the electrical stimulation intensity responsive to a tremor ([0146, 0150]). The modified Rosenbluth et al. discloses the invention substantially as claimed but does not explicitly disclose “the frequency of the tremor is between 3.5 kHz and 8 kHz” and “wherein, responsive to the frequency of the tremor falling below a threshold lower than 3.5 kHz, the control circuitry or the controller is further configured to reduce an intensity of the electrical stimulation signal applied to at least one electrode of one of the different subsets”. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the sensed tremor frequency threshold in order to provide the predictable results of modifying the treatment to meet specific patient therapeutic needs and requirements. As such, the further modified Rosenbluth et al. would disclose a device that is “responsive to the frequency of the tremor falling below a threshold lower than 3.5 kHz, the control circuitry or the controller is further configured to reduce an intensity of the electrical stimulation signal applied to at least one electrode of one of the different subsets”.
As to 19, Rosenbluth et al., and thus the modified Rosenbluth et al. discloses sensors with the control circuitry or a controller being configured to receive signals from the sensor in real time as the electrical stimulation signal is applied and, responsive to sensed data, adjust at least one of an amplitude, a phase, or a frequency of the electrical stimulation signal being applied to the different subsets of electrodes while continuing to monitor with the sensor ([0127, 0173, 0177-0179]). Rosenbluth et al. does not explicitly disclose an impedance sensor. However, Page et al. impedance testing circuitry ([0057-0059]). Therefore, Page et al. discloses a means for sensing impedance, and thus necessarily discloses an “impedance sensor” for sensing impedance. Therefore, the modified Rosenbluth et al. does in fact disclose an impedance sensor (via the sensing and stimulating electrodes of Page et al.).
As to claim 20, Rosenbluth et al, and thus the modified Rosenbluth et al., discloses responsive to the flexible band being arranged around the wrist, the first electrode is positioned on a dorsal side of the wrist, the second electrode is positioned on a ventral side of the wrist, and the third electrode is positioned on the wrist between the first electrode and the second electrode ([0164-0167]; Figures 14H-14L).
As to claim 21, Rosenbluth et al. discloses a system for therapeutic electrical stimulation of an arm or wrist (Figure 1; [0045]) with a flexible band configured to be secured around the arm or wrist of a patient ([0164-0165]), the flexible band supporting an electrode carrier ([0164-0166]); a set of electrodes ([0053-0054, 0173, 0197]) , at least a first of which is part of the electrode carrier and at least a second of which is in or on the substrate such that the first electrode of the set of electrodes is in physical contact with a dorsal side of the arm or wrist (Figures 14H-14L; [0166]) and the second electrode of the set of electrodes is in physical contact with a ventral side of the arm or wrist in response to the arm or wrist resting upon the substrate (Figures 14H-14L; [0166]), the set of electrodes including a third electrode that is part of the electrode carrier or in or on the substrate ((Figures 14H-14L; [0164-0166]); a stimulation module in electrical communication with the electrode carrier (Abstract, [0135, 0213]), the stimulation module including signal generation circuitry configured to generate an electrical stimulation signal as a direct current (DC) pulse ([0143]) and control circuitry configured to sequentially activate different subsets of electrodes in the set of electrodes ([0053, 0173]), each of the different subsets including one or more electrodes of the set of electrodes activated as a signal source for the electrical stimulation signal and one or more electrodes of the set of electrodes activated as a signal sink for the electrical stimulation signal ([0053, 0173, 0206]), the set of electrodes being configured to deliver electrical stimuli from the stimulation module to the arm or wrist for exciting a first nerve selected from the median, radial or ulnar nerve ([0137]).
Additionally as to claim 21, Rosenbluth et al. discloses the invention substantially as claimed but does not explicitly disclose generating “an electrical stimulation signal as a direct current (DC) pulse at a frequency between 10 kHz and 50 kHz”. Page et al. discloses providing electrical stimulation signals at a frequency of 10kHz to 50kHz ([0004, 0056, 0065]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the frequency of the electrical stimulation signal of Rosenbluth et al. to include a frequency between 10 kHz and 50 kHz as disclosed by Page et al., since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233 (see MPEP 2144.05). Furthermore, such a modification would provide the predictable results of modifying the electrical stimulation signals to meet specific patient therapeutic needs and requirements.
As to claim 22, Rosenbluth et al, and thus the modified Rosenbluth et al., discloses the flexible band includes a fastener configured to secure the flexible band around the arm or wrist relative to the substrate (Figures 14H-14L; [0103]), and wherein the substrate is generally flat while lying on a flat surface (Figures 14H-14L; [0103]).
As to claim 23, Rosenbluth et al, and thus the modified Rosenbluth et al., discloses the substrate includes an indicium indicating a placement location of the arm or wrist relative to the substrate prior to securing the flexible band around the arm or wrist (Figures 14H-14L; [0103]).
As to claim 24, Rosenbluth et al, and thus the modified Rosenbluth et al., discloses an indicator that indicates a proper placement of the arm or wrist relative to the placement location (Figures 14H-14L; [0103, 0174]).
As to claim 25, Rosenbluth et al, and thus the modified Rosenbluth et al., discloses an indicator having a first state indicating that the electrical stimulation signal is absent and a second state indicating that the electrical stimulation signal is being delivered via at least one of the subsets of electrodes in the set of electrodes (Figures 21A-21D; [0128]).
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over the modified Rosenbluth et al., as applied to claims 1-25 above, in further view of Gilmour (US 2007/0197946 A1). The modified Rosenbluth et al. disclose the invention substantially as claimed but does not explicitly disclose pneumatic or inflatable elements coupled to the flexible band to apply pressure to those electrodes that are in physical contact with the arm or wrist while the electrical stimulation signal is applied to said electrodes. Gilmour discloses inflatable bladders that can pneumatically be inflated ([0020, 0069, 0077]; Figure 23). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the flexible band of the modified Rosenbluth et al. to include an inflatable bladder as disclosed by Gilmour in order to provide the predictable results of ensuring sufficient contact with the electrodes though a customizing individualized fit (Gilmour, [0077]) which would optimize the treatment device to meet specific patient therapeutic needs and requirements.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALYSSA M ALTER whose telephone number is (571)272-4939. The examiner can normally be reached M-F 8am-4pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David E Hamaoui can be reached at (571) 270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ALYSSA M ALTER/Primary Examiner, Art Unit 3796
Prosecution Insights