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 .
Response to Arguments
Applicant’s arguments with respect to claims 17 and 19-40 have been considered but are moot because the new ground of rejection necessitated by amendment. Claims 17 and 19-40 are rejected under Mueller et al. (US Patent Publication 20100042180 A1) in view of Suzuki (US 20070229299 A1) as detailed below.
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.
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Claims 17 and 19-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 10,773,080 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because both disclose a system for applying transcutaneous electrical stimulation to a user an electrode configured to provide the electrical stimulation and a device releasably coupled to the elongate support and comprising a user-pushable button, wherein the device is configured to linearly increase an amplitude of the electrical stimulation to a preconfigured upper amplitude during a first portion of a time span and to maintain the amplitude of the electrical stimulation at a second amplitude lower than the preconfigured upper amplitude when the user-pushable button is pressed during the first portion of the time span.
Response to Arguments
Applicant's arguments filed May 13, 2025 have been fully considered but they are not persuasive.
In paragraph 41 of US Patent Publication 20230108691 A1, “In a preferred embodiment, the system is further configured for acceleration of the ramp-up upon continuously pushing of said button for several seconds. This is advantageous as a patient who is used to treatment of migraine attacks by means of the system can get a speedier ramp-up and thus faster headache relief. By pressing said button continuously for several seconds, the optimal and most effective amplitude of 16 mA can be reached within 30 seconds. The system is hereby configured to increase the amplitude rapidly while the button is being continuously pushed. When the switch is subsequently released, the amplitude stabilizes and remains constant. By pressing the button again, the intensity increases again as long as the button is pushed”.
Applicant argues that “Mueller fails to teach or suggest a device configured to linearly increase an amplitude of electrical stimulation to a preconfigured upper amplitude during a first portion of a time span and maintain the amplitude of the electrical stimulation at a second amplitude lower than the preconfigured upper amplitude for a second, later portion of the time span when the user-pushable button is pressed and released during the first portion of the time span” (page 7 of Remarks).
However, based on the Applicant’s specification (specifically paragraph 41 above), “the system is hereby configured to increase the amplitude rapidly while the button is being continuously pushed”, it appears that the Applicant’s invention functions the same as the invention of Meuller et al. (page 7 of Remarks).
Furthermore, if the Applicant’s invention achieves the “linearly increasing amplitude” when a button is pressed and held, then likewise Meuller et al. also meets the limitation.
Additionally, the Applicant argues that Meuller et al. does not teach or suggest “maintaining the amplitude of the electrical stimulation at a second amplitude lower than the preconfigured amplitude when a user-pushable button is pressed”. However, the examiner respectfully disagrees. Meuller et al. discloses in paragraph 55, “When device 20 is powered on and ON/ADJUST/OFF button 44 is held, the stimulation intensity increases until button 44 is released, up to a preset maximum”. Therefore, Meuller et al. does in fact suggest “a second amplitude lower than the preconfigured amplitude when a user-pushable button is pressed”.
When the button is “pressed and released during a first portion of time span” it “linearly increase an amplitude of the electrical stimulation at a constant rate” towards a “preconfigured upper amplitude” during the first portion of time. The system of Mueller et al. then “maintains the amplitude of electrical stimulation at the second amplitude lower than the preconfigured upper amplitude during the second, later portion of the time span” after the button is release. Should the user, while operating the device in Mueller et al. wish to further increase the amplitude towards the preconfigured upper amplitude, the user would continuously press the “user-pushable button during the second, later portion of the time span”. ([0015, 0055-0058, 0061]; “When device 20 is powered on and ON/ADJUST/OFF button 44 is held, the stimulation intensity increases until button 44 is released, up to a preset maximum” [0055] and “when electrical stimulation device 20 is powered on and toggle button 44 of this embodiment is depressed, the stimulation intensity step increases to a preset maximum or step decreases to a preset minimum with each depression” [0056]).
Therefore, for the reasons stated above and previously made of record, the claims remain rejected under Meuller et al. as detailed below.
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.
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.
Claims 17, 19-28 and 30-40 are rejected under 35 U.S.C. 103 as being unpatentable over Mueller et al. (US Patent Publication 20100042180 A1) in view of Suzuki (US 20070229299 A1).
As to claim 17, Mueller et al. discloses applying transcutaneous electrical stimulation to a user ([0012-0013]) comprising: an elongate support comprising an electrode configured to provide the electrical stimulation (adhesive layer; [0047]; see Figures); and a device (control module, depicted as 40 in Figures 1-8) releasably coupled to the elongate support ([0064-0065]) and comprising a user-pushable button ([0015]), wherein the device is configured to automatically (see Response to Arguments above) linearly increase an amplitude of the electrical stimulation at a constant rate to a preconfigured upper amplitude during a first portion of a time span and to maintain the amplitude of the electrical stimulation at a second amplitude lower than the preconfigured upper amplitude when the user-pushable button is pressed during the first portion of the time span ([0015, 0055-0058, 0061]; “When device 20 is powered on and ON/ADJUST/OFF button 44 is held, the stimulation intensity increases until button 44 is released, up to a preset maximum” [0055].)
When the button is “pressed and released during a first portion of time span” it “linearly increase an amplitude of the electrical stimulation at a constant rate” towards a “preconfigured upper amplitude” during the first portion of time. The system of Mueller et al. then “maintains the amplitude of electrical stimulation at the second amplitude lower than the preconfigured upper amplitude during the second, later portion of the time span” after the button is release. Should the user, while operating the device in Mueller et al. wish to further increase the amplitude towards the preconfigured upper amplitude, the user would continuously press the “user-pushable button during the second, later portion of the time span”. ([0015, 0055-0058, 0061]; “When device 20 is powered on and ON/ADJUST/OFF button 44 is held, the stimulation intensity increases until button 44 is released, up to a preset maximum” [0055] and “when electrical stimulation device 20 is powered on and toggle button 44 of this embodiment is depressed, the stimulation intensity step increases to a preset maximum or step decreases to a preset minimum with each depression”[0056]).
Additionally, as to claim 17, Mueller et al. discloses increasing the amplitude when the user-pushable button is continuously pressed, but does not explicitly disclose “increase the amplitude of the electrical stimulation at a second rate, faster than the first rate when the user-pushable button is continuously pressed during the second, later portion of the time span”. Suzuki discloses “various operational functions by the conventionally-known infrared remote control transmitters is the so-called "continuous depression function", which is intended to cause desired operated equipment to perform a special function in response to a user continuously performing one particular operation (i.e., "continuous depressing operation") on the infrared remote control transmitter. For example, the continuous depression function can be used as a function to gradually increase a volume-up (i.e., volume-increasing) or volume-down (volume-decreasing) speed of an amplifier in accordance with the passage of time, if the user continues to depress a volume-up or volume-down button on the infrared remote control transmitter. The continuous depression function can also be used as a function to gradually increase a fast-forwarding or fast-rewinding speed of an amplifier in accordance with the passage of time, if the user continues to depress a fast-forward or fast-rewind button of a CD player or video player via the infrared remote control transmitter” ([0005]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the user-pushable button that adjust the stimulation intensity of Mueller et al. to increase the amplitude of the electrical stimulation at a second rate, faster than the first rate when the user-pushable button is continuously pressed as disclosed by Suzuki to enable an operation of a known technique (depressing a button continuously to increase the speed of operation) to a known device (a controller) to yield the achievement of determining optimized simulation parameters at an increased speed to provide the predictable results of achieving comfortable and effective stimulation for the patient at an accelerated rate.
As to claim 19, Mueller et al., and thus the modified Mueller et al., discloses the device is configured to maintain the amplitude of the electrical stimulation at the preconfigured upper amplitude during a second, later portion of the time span when the user-pushable button is not pressed during the first portion of the time span ([0053, 0055]).
As to claim 20, Mueller et al. discloses “treatment period, which can be several minutes to several hours or more” ([0047,0082]). Therefore, since an hour is longer than 10 minutes, Mueller et al., and thus the modified Mueller et al., disclose “the second portion of the time span is at least 10 minutes”.
As to claim 21, Mueller et al., and thus the modified Mueller et al., discloses the electrical stimulation comprises electrical pulses, and the device is configured to set one or more of a pulse frequency of the electrical pulses, a pulse width of the electrical pulses, a pulse amplitude of the electrical pulses, a pulse ramp-up time for the electrical pulses, a pulse ramp-up slope of the electrical pulses, and the time span ([0076-0077]).
As to claims 22-24, the modified Mueller et al. discloses the invention substantially as claimed but does not explicitly disclose the electrical stimulation pulses are consecutive biphasic electrical pulses with a pulse frequency between about 80 Hz and about 300 Hz or a pulse width that is 250 µs. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the electrical stimulation pulses of Mueller et al. to be consecutive biphasic electrical pulses with a pulse frequency between about 80 Hz and about 300 Hz or consecutive biphasic electrical pulses with a pulse width that is 250 µs in order to provide the predictable results of optimizing treatment and stimulation parameters to meet specific patient therapeutic goals and requirements ([0076, 0079]).
As to claim 25, Mueller et al., and thus the modified Mueller et al., discloses the elongate support further comprises an adhesive (adhesive layer; [0047]; see Figures).
As to claim 26, Mueller et al., and thus the modified Mueller et al., discloses the adhesive comprises a hypoallergenic gel ([0073]).
As to claim 27, Mueller et al., and thus the modified Mueller et al., discloses “placement of device 10 on many different parts of the body to provide electrical stimulation for therapeutic treatment and pain management” ([0046]) and “can provide near universal application to all parts of the body”([0080]). As such, since the forehead of a user is considered part of the body, Mueller et al. discloses the elongate support is configured to couple to different parts of the body (“universal application to all parts of the body”([0080]), Mueller et al. discloses the elongated support is configured to couple to a forehead of the user.
As to claim 28, Mueller et al., and thus the modified Mueller et al., discloses the system is configured to deliver the electrical stimulation ([0017]). Thus Mueller et al. is necessarily configured to deliver the electrical stimulation to any target, including the trigeminal nerve of the user. Furthermore, Mueller et al. discloses “placement of device 10 on many different parts of the body to provide electrical stimulation for therapeutic treatment and pain management” ([0046]) and “can provide near universal application to all parts of the body”([0080]). Therefore, since Mueller et al. configured to deliver electrical stimulation to “near universal application to all parts of the body” ([0080]), Mueller et al. is necessarily configured to deliver the electrical stimulation to a trigeminal nerve of the user.
As to claim 29, the modified Mueller et al. discloses the invention substantially as claimed with electrical stimulation pulses having “a predefined fixed maximum level” ([0014-0015]), but does not explicitly disclose a pulse amplitude of the preconfigured upper amplitude is between about 5 mA and about 25 mA. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the upper amplitude of the preset maximum stimulation level of Mueller et al. to be “between about 5 mA and about 25 mA” in order to provide the predictable results of optimizing treatment and stimulation parameters to meet specific patient therapeutic goals and requirements ([0076, 0079]).
Additionally, as to claim 29, the functional language and introductory statement of intended use of claim 29 has been carefully considered but are not considered to impart any further structural limitations over the prior art. Since the modified Mueller et al. utilizes an electrical pulse amplitude of the preconfigured upper amplitude between 5 mA and about 25 mA as claimed by the Applicant, the modified Mueller et al. is therefore capable of being used to treat a migraine. In addition nothing prevents the modified Mueller et al. from being used to treat a migraine. Therefore, the system of the modified Mueller et al. is capable of being used to treat a migraine.
As to claim 30, Mueller et al. discloses “Device 20 can then be worn unobtrusively for a desired treatment period, which can be several minutes to several hours or more” ([0082]). The modified Mueller et al. discloses the invention substantially as claimed with treatment being several minutes to hours, but does not explicit disclose “the first portion of the time span is between about 5 minutes and about 20 minutes”. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the treatment time span to be between about 5 minutes to about 20 minutes” in order to provide the predictable results of optimizing treatment and stimulation parameters to meet specific patient therapeutic goals and requirements ([0076, 0079]).
As to claim 31, Mueller et al., and thus the modified Mueller et al., discloses the device is configured to rapidly increase the amplitude of the electrical stimulation to the preconfigured upper stimulation amplitude when the user-pushable button is pressed continuously for several seconds during the second portion of the time span ([0055-0058, 0061]).
As to claim 32, Mueller et al., and thus the modified Mueller et al., discloses the device is configured to increase the amplitude of the electrical stimulation to the preconfigured upper stimulation amplitude within 30 seconds when the user-pushable button is pressed continuously for several seconds during the second portion of the time span ([0055-0058, 0061]).
As to claim 33, Mueller et al., and thus the modified Mueller et al., discloses the device is configured to maintain the amplitude of the electrical stimulation at a third amplitude lower than the preconfigured upper amplitude when the user-pushable button is released after continuous pressing ([0055-0058, 0061, 0075]).
As to claim 34, the modified Mueller et al. discloses the invention substantially as claimed with electrical stimulation pulses that ramp up in intensity to a preconfigured or preset maximum level ([0014-0015]), but does not explicitly disclose increase the amplitude of the electrical stimulation during the first portion of the time span with a slope of between about 8 µA/s and about 83 µA/s. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the increasing amplitude slope of Mueller et al. to be between “about 8 µA/s and about 83 µA/s” in order to provide the predictable results of optimizing treatment and stimulation parameters to meet specific patient therapeutic goals and requirements ([0076, 0079]).
As to claim 35, Mueller et al. discloses a wired connection with a flexible cable or lead wire (depicted as 26 in Figures; [0046, 0048]). The modified Mueller et al. discloses the invention substantially as claimed but does not explicitly disclose a wireless connection. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the wired connection of Mueller et al. for a wireless connection in order to provide the predictable results of allowing the electrode(s) to have a universal configuration that can be positioned at any location without the constrains of wire length. Additionally wireless communication would permit multiple locations to be stimulated and treated without additional wires to manage. Furthermore, wireless communication and data transmission is extremely well known in the medical device arts.
As to claim 36, Mueller et al., and thus the modified Mueller et al., discloses the device is configured to initiate the electrical stimulation when the user-pushable button is pressed before the first portion of the time span ([0062, 0075]).
As to claim 37, the modified Mueller et al. discloses the invention substantially as claimed with electrode(s) but does not explicitly disclose the electrode is a bipolar electrode. It would have been obvious to one having ordinary skill in the art at the time the invention was made for Mueller et al. to employ bipolar electrodes since they are extremely well known in the electrical stimulation art. Furthermore, such a modification would meet specific patient therapeutic needs and requirements.
As to claim 38, Mueller et al., and thus the modified Mueller et al., discloses the device is configured to electrically couple to the electrode of the elongate support (Figures 1-8A).
As to claim 39, Mueller et al. discloses coupling the electrodes via a snap connector ([0064]). The modified Mueller et al. discloses the device substantially as claimed with a mechanical connection means between the electrode and the elongate support, but does not explicitly disclose “magnetically coupled”. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the snap connector of Mueller et al. to be a magnetic connection in order to provide the predictable results of enabling individuals with reduced manual dexterity or strength, who otherwise would struggle to engage the snap mechanism, to alight the components.
As to claim 40, Mueller et al., and thus the modified Mueller et al., discloses the electrode of the elongate support comprises two conductive areas and the device further comprises two metallic contacts, and wherein the two metallic contacts of the device releasably couple to the two conductive areas of the electrode ([0064], “Snaps 66 and 68 are adapted to be securely yet removably coupled to each other, providing both mechanical and electrical couplings between control module 40 and electrode 22”).
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 ALYSSA M ALTER whose telephone number is (571)272-4939. The examiner can normally be reached M-F 8am-4pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David E Hamaoui can be reached on (571) 270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALYSSA M ALTER/Primary Examiner, Art Unit 3796