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 .
IDS
Applicant should note that the large number of references in the attached IDS have been considered by the examiner while conducting a search of the prior art in a proper field of search. See MPEP 609.05(b). Applicant is requested to point out any particular references in the IDS which they believe may be of particular relevance to the instant claimed invention in response to this office action.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the inductive charging interface and visual indicators must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The use of the term Velcro (VELCRO®), which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3 and 13 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claims 3 and 13 each recite “the device comprises visual indicators to facilitate alignment on the user.”. It is unclear what the device is being aligned to. This language is therefore indefinite.
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 1-2, 5-6, 8-12, 15-16 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over DiUbaldi et al. US 2009/0132018 in view of McCombie et al. US 2010/0298655 and further in view of Rocon De Lima US 2014/0336722 .
Regarding claims 1-2, 5-6, 11-12, 15-16 and 20: DiUbaldi discloses a nerve stimulation device (“nerve stimulation patch”, abstract) and an inductive charging interface configured to inductively charge the nerve stimulation device 100 (figures 1 -10 and paragraph 00025; DiUbaldi discloses that the battery can be recharged via inductive coupling to transfer energy via a shared magnetic field, this would inherently include inductive coils in both the charging and receiving devices as is known in the art); a plurality of electrodes 124A/124B (figures 10) configured to deliver transcutaneous stimulation to nerves (paragraph 00274). The device of DiUbaldi is configured to stimulate nerves this would inherently include nerves in the wrist including the medial and ulnar nerves. Further the language found in the claims directed towards “nerves of a wrist” is considered to be intended use and or a functional limitation. DiUbaldi is disclosing stimulation of nerves transcutaneous as discussed above, therefore DiUbaldi is considered to at least be capable of stimulating nerves in the wrist. Applicant is reminded that it makes no difference if the devices of the prior art are used in a different way since a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use.
DiUbaldi therefore discloses the claimed invention however DiUbaldi does not specifically disclose an adjustment ring and clinching strap which are configured to allow for tightening and positioning the device on the wrist of the user. McCombie however teaches of a vital sign monitor 72 (“wrist-worn transceiver”, figure 0059) which
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[AltContent: textbox (Figure 1: McCombie figure 4:)]is worn on the wrist. The vital sign monitor includes ECG sensors/electrodes and a circuit contained in the housing (paragraph 0067). The vital sign monitoring device further includes a flexible strap 90 (figure 4, considered to be a cinching strap) in which an end of the strap treads through D-rings in the housing 106, then circles back to adhere to itself and secure the device to the user’s wrist (paragraph 0066, figure 4). In the design by McCombie various sized wrists can be accommodated by the adjustable strap. It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify DiUbaldi to include a wrist strap which loops through D-rings to operably attach the device to the user’s wrist, as taught by McCombie in order to removably attach the device to the user’s wrist.
DiUbaldi/MCCombie therefore discloses the claimed invention however DiUbaldi/MCCombie does not specifically disclose stimulation configured to reduce tremor. Rocon De Lima however teaches of a neuroprosthetic device which suppresses tremors via neurostimulation (abstract). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify DiUbaldi/MCCombie to include neurostimulation to suppress tremor, as taught by Rocon De Lima, in order to treat pathological tremor.
Regarding claims 8 and 18: DiUbaldi discloses a rechargeable battery 108 (figure 3, paragraph 0025), an inductive charging interface with an inductive coil (paragraphs 0025 and 0019; DiUbaldi discloses that the battery can be recharged via inductive coupling to transfer energy via a shared magnetic field, this would inherently include inductive coils in both the charging and receiving devices as is known in the art), a communication module to communicate with an external device (paragraphs 0012 and 0030) and a stimulator 264 (figure 12) in electrical communication with the electrodes 232 (figure 12) which provides electrical pulses to the electrodes (paragraph 0083). However DiUbaldi does not specifically disclose a user interface. McCombie however teaches of a user interface (paragraph 0066, figure 4). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify DiUbaldi, to include a user interface, as taught by McCombie , in order to display data.
Regarding claims 9 and 19: DiUbaldi/MCCombie/Rocon De Lima discloses the claimed invention. Rocon De Lima further teaches of EMG sensors and or movement sensors used to sense tremor (paragraphs 0009 and 0088). It therefore would have been obvious to one of ordinary skill in the art to modify DiUbaldi/MCCombie/Rocon De Lima to further include sensors to determine tremor in a patient, as taught by Rocon De Lima, in order to use feedback to control the tremor (paragraph 0088).
Regarding claim 10: DiUbaldi/MCCombie/Rocon De Lima discloses the claimed invention. Rocon De Lima further teaches of stimulation delivered at 100 Hz or higher (paragraphs 0132 and 0149). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify DiUbaldi/MCCombie/Rocon De Lima to include stimulation at 100 Hz and higher, as taught by Rocon De Lima, in order to suppress tremor.
Claims 3 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over DiUbaldi et al. US 2009/0132018 in view of McCombie et al. US 2010/0298655 and further in view of Rocon De Lima US 2014/0336722 and further in view of Van Acht et al. US 2011/0313327.
Regarding claims 3 and 13 as understood: DiUbaldi/MCCombie/Rocon De Lima discloses the claimed invention however DiUbaldi/MCCombie/Rocon De Lima does not disclose visual indicators for alignment. Van Acht however teaches of the use of orientation indicators (abstract, paragraph 0023). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify DiUbaldi/MCCombie/Rocon De Lima to include indicators, as taught by Acht, in order to orientate the device with respect to the body part (paragraph 0023).
Claims 3, 7, 14 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over DiUbaldi et al. US 2009/0132018 in view of McCombie et al. US 2010/0298655 and further in view of Rocon De Lima US 2014/036722 and further in view of Weast et al. US 2013/0106684.
Regarding claims 4 and 14: DiUbaldi/MCCombie/Rocon De Lima discloses the claimed invention however DiUbaldi/MCCombie/Rocon De Lima does not disclose the use of a flexible circuit. Weast however teaches of a device strapped to a user’s arm (figure 1) which has a flexible circuit (paragraphs 0029, 0165) It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify DiUbaldi/MCCombie/Rocon De Lima to include a flexible circuit, as taught by Weast, in order to support additional components associated with the device (Weast paragraph 0169).
Regarding claims 7 and 17: DiUbaldi/MCCombie/Rocon De Lima discloses the claimed invention however DiUbaldi/MCCombie/Rocon De Lima does not disclose the use of Velcro, which is considered to be a hook and loop configuration. Weast however further teaches that the fastening mechanism can include a hook and loop fastener (paragraph 0200). It therefore would have been obvious to one of ordinary skill in the art, at the time the invention was filed, to modify DiUbaldi/MCCombie/Rocon De Lima, to further include the hook and loop fastener of McCombie, in order to releasably connect wearable device.
Double Patenting
No double patenting rejections will be made at this time using the following patents;
9,802,041
10,179,238
10,561,839
10,960,207
12,109,413
The current claims under examination require an inductive charging interface, an adjustment ring and cinching strap as well as transcutaneous stimulation configured to reduce tremor. These limitations are not found in the claims of the above issued patents. In order to do a Double Patenting rejection several secondary references would be required, therefore the Double Patenting rejection would be in error.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAULA J. STICE whose telephone number is (303)297-4352. The examiner can normally be reached Monday - Friday 7:30am -4pm MST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Carl H Layno can be reached at 571-272-4949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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PAULA J. STICE
Primary Examiner
Art Unit 3796
/PAULA J STICE/Primary Examiner, Art Unit 3796