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 (over 1000) 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 fourth electrode on a dorsal side of the wrist, the first electrode and the fourth electrode forming a first electrode pair, the second electrode and the fourth electrode forming a second electrode pair and a third electrode and the fourth electrode forming a third electrode pair must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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[AltContent: textbox (Figure 1: Figures 3A, 3B and 3C of serial number 19/271,609)]Regarding the fourth distally placed electrode and the first, second and third electrode pairs. The drawings consistently show three electrodes. Figures 3A and 3B are annotated and included as figure 1 of this office action. In figures 3A and 3B electrode 300 is a dorsal electrode found on the dorsal side of the wrist and is described as the reference electrode, electrode 302 is found on the ventral side of the wrist and electrode 304 is on the lateral side of the wrist. The drawings do not demonstrate or show a fourth electrodes or any electrode pairs which include a fourth electrode shown in the drawing, as is claimed in claim 1 as well as claim 11.
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.
Claim Rejections - 35 USC § 112
Claims 1 and 11 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1, lines 19-27 recite:
wherein the fourth electrode is positioned on the wearable device such that, when the wearable device is secured to the wrist of the user, the fourth electrode is positioned along a dorsal side of the wrist,
wherein the first electrode and the fourth electrode form a first electrode pair,
wherein the second electrode and the fourth electrode form a second electrode pair, and
wherein the third electrode and the fourth electrode form a third electrode pair.
Claim 11 recites:
The system of claim 10, further comprising a fourth electrode positioned on the wearable device such that, when the wearable device is secured to the wrist of the user, the fourth electrode is positioned on an opposite side of the wrist as the second electrode.
US Patent Publication number 2025/0339685 corresponds to this application 19/271,609 will be used for reference paragraph numbers. Paragraph 0176 recites that there can be an additional electrode to target an ulnar nerve. This is the only paragraph/sentence which contemplates the possibility of a fourth electrode. This brief recitation in no way explains potential positioning of the fourth electrode on a dorsal side of a wrist of a user or the use of the fourth electrode to establish stimulation electrode pairs, which are limitations required in both claims 1 and 11.
Specifically, regarding claim 1, as is seen in figure 3A, there are three electrodes: 300 dorsal electrode, 302 ventral electrode and 304 the lateral electrode. However, claim 1 requires a ventral electrode (first electrode), a lateral electrode (second electrode) and a medial electrode (third electrode) as well as dorsal electrode (fourth electrode). Electrodes 1, 2 and 3 are in electrical communication with the pulse generator however electrode 4 may or may not be in electrical communication with the pulse generator; it is not within the claim language as to how the 4th electrode is wired, nor is this in the specification. This configuration/species is entirely missing from the disclosure including the drawings (see the above drawing objections).
Specifically regarding claim 11: the first electrodes is placed ventrally, the second electrode is lateral and the third electrode is dorsal. Then in claim 10 the fourth electrode would be placed medially. This is not disclosed nor is this discussed in the specification or drawings.
Although this is not considered to be an enablement issue in that the language is understood, the specification fails to disclose these specific orientations for the electrodes. The goal of the written description is to clearly convey that the applicant/inventor had invented the subject matter which is claimed, in this case it is not clear because the embodiments claimed are completely lacking in the disclosure and associated drawings. Further the fourth electrode and the fourth electrodes associated placement on the device as well as stimulation pairs of electrodes are considered to be essential or critical features in the claims presented. Each limitation within the claims must be expressly, implicitly or inherently supported by the originally filed disclosure. The forth electrodes, electrode pairs and a distal electrode placement are not limitations considered to be implicitly or inherently supported by the specification because there is no mention of an additional or a fourth electrode which is located either distally (which would require a movement of electrodes) or medially. In addition there is no disclosure as to pairing the electrodes in this specific manner as required by claim 1. Although electrode pairs are discussed (paragraph 0175-0176) this is only discussed with reference to the three electrode design. It is not clear from the specification that the applicants/inventors had contemplated or reduced to practice a four electrode design with a fourth electrode placed either dorsally or medially. MPEP2163.05 II specifically recites “The introduction of claim changes which involve narrowing the claims by introducing elements or limitations which are not supported by the as-filed disclosure is a violation of the written description requirement of 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph.” In this case this appears to be an undisclosed species.
Claim 2 recites “a processor configured to receive data from a cloud and to adjust one or more stimulation parameters based on the received data wherein the one or more stimulation parameters are determined based on application of one or more neural networks or predictive algorithms”.
Claim 3 recites “further comprising a processor configured to receive data from a cloud and to adjust one or more stimulation parameters based on the received data.”
Claim 4 recites “wherein the one or more stimulation parameters are determined based on application of one or more neural networks”.
Claim 12 recites “further comprising a processor configured to receive cloud data and to adjust one or more stimulation parameters generated by the pulse generator.”
Claim 13 recites “wherein the one or more stimulation parameters are determined based on application of one or more neural networks.”
Claims 2-4 and 12-13 are all considered to be computer implemented claim limitations. Paragraph 0217 states that an algorithm can be applied. Paragraph 0219 mentions dynamic algorithms to help with comfort and reduce redness and rash. And paragraph 0222 discusses broadly an algorithm for calculating triggers for the stimulation. However nowhere in the specification is it discussed how data received from the cloud can be or is used to adjusted stimulation parameters. Nowhere is it discussed how the stimulation parameters can be adjusted via neural networks or predictive algorithms. This simply is not disclosed. There are some high level discussions and graphs are shown in figures 25B-C however there are not clear steps or procedures which demonstrate an algorithm. Paragraph 0026 shows a basic flow chart however, there is no discussion as to how signals are analyzed, information combined, using historical data and external data to eventually adjust treatment.
With respect to the limitations in claims 2-4 and 12-13 because no programs/algorithms or steps and procedures are disclosed for adjusting stimulation parameters based on data from the cloud, neural networks or predictive algorithms there is more than routine experimentation needed. For software claims if the algorithm or steps/procedures to perform the computer function are not explained or are missing one of ordinary skill in the art would not know how the inventor intends the function to be performed and undue experimentation would be required.
Based on the above analysis claims 1-4 and 11-13 fail to have adequate written description.
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.
Claim 2 is 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. Claim 2 recites “wherein the fourth electrode is positioned on the wearable device on an opposite side of an axis extending between the second electrode and the third electrode than the first electrode”. The language “than the first electrode” is not understood, this could be missing punctuation however that is unclear.
Claim Rejections - 35 USC § 102
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.
Claims 10-11 and 20 rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lathrop US 2008/0097564.
Regarding claim 10: Lathrop discloses a pulse generator 42 (figure 5, paragraph 0051 “Microprocessor 42 is preferably pre-programmed for selecting and rotating through stimulus pulse parameters.”); a wearable device 10 (figure 2) secured to a patents wrist (figure 2); the wearable device includes a first electrode placed on the ventral side of the wrist 28 (figure 3), a second electrode positioned between a midline
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[AltContent: textbox (Figure 2: Figure 3 of US 2008/0097564.)]of a ventral side and a midline of a dorsal side 24 (figure 3: electrodes 24 are offset from the midline and lie between the two midlines for dorsal and ventral) and a third electrode positioned on the dorsal side of the wrist 26 (figure 3). Each electrode is operably connected to the pulse generator via lead wires 36 (figure 5).
Regarding claim 11: Lathrop discloses a fourth electrode 30 (figure 3) positioned on an opposite of the wrist than the second electrode 24 (figure 3).
Regarding claim 20: the electrodes of Lathrop are arranged in a wrist device which is considered to have the electrodes spaced circumferentially (figure 2).
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.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Buckley et al. US 9,332,918 in view of Bijelic et al. US 2008/0027507 and further in view of Zanakis et al. US 5,433,735.
Regarding claim 1: Buckley discloses a wearable device 40 (figure 5C) configured to be secured to a wrist of a user which includes a first electrode positioned to stimulate a medial nerve (“medial” figure 5B) which is positioned on the ventral side of the wrist, a second electrode positioned to stimulate a radial nerve (“radial, figure 5B) which is positioned on the lateral surface and a third electrode positioned to stimulate an ulnar nerve (“ulnar” figure 5B) which is positioned on the medial surface. Each of the electrodes radial/median/ulnar are connected to a pulse generator 55 (figure 7) via wires 46 (figure 5B). Buckley further discloses, see figures 6A/6B, that the radial electrodes R1/R2 form one electrode pair, medial electrodes M1/M2 form a second electrode pair and ulnar electrodes U1/U2 form a third electrode pair (column 2, lines 30-40), this creates an anode/cathode configuration over each associated nerve (column 8, line 11). Buckley does not disclose a fourth electrode which can create pairs between electrode 1-4, electrodes 2-4 and electrodes 3-4 with the electrode being placed on the dorsal wrist, this is considered to be a common anode or common cathode configuration. Bijelic however teaches of a design with a common ground or counter electrode (paragraph 0022) or a common anode (paragraph 0046). Figure 5 of Bijelic discloses this structure with the cathodes in the array 256 and the anode 256. It would
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[AltContent: textbox (Figure 3: figures 5B/5C of US Patent No. 9,332,918)]have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Buckley to modify the design to include a common anode, as taught by Bijelic, to direct current from the cathode to the anode to restore hand function (Bijelic, paragraph 0049). Buckley/Bijelic therefore discloses the claimed invention however Buckley/Bijelic does not disclose that the anode is placed on a dorsal surface. Zanakis however teaches of a dorsally placed anode (column 5, lines 45-46). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Buckley/Bijelic to include a dorsally placed electrode as a cathode, as taught by Zanakis, in order to establish current flow between the electrodes (column 5 lines 45-49).
Claims 2-5 are rejected under 35 U.S.C. 103 as being unpatentable over Buckley et al. US 9,332,918 in view of Bijelic et al. US 2008/0027507 and further in view of Zanakis et al. US 5,433,735 and further in view of Heldman et al. US 2014/0074179 and further in view of Racon De Lima et al. US 2014/0336722.
Regarding claims 2-5: Buckley/Bijelic/Zanakis discloses the claimed invention. Buckley further discloses the fourth electrode positioned on an opposite side of an axis
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[AltContent: textbox (Figure 4: Figure 5B US Patent No. 9,332,918)]extending between the second and third electrodes (figure 5B). Buckley/Bijelic/Zanakis does not disclose the use of a processor which receives cloud data to adjust stimulation parameters using neural networks. Heldman however teaches of cloud based databases for analyzing and further processing data (paragraph 0070). Algorithms and programs can be stored in the cloud (paragraph 0108). Heldman further teaches of using a neural network for parameter adjustment (paragraphs 0051, 0142-0143). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Buckley/Bijelic/Zanakis to include programs stored in the cloud, including neural networks, as taught by Heldman, to process data and suggest stimulation parameters based on the analysis.
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Buckley et al. US 9,332,918 in view of Bijelic et al. US 2008/0027507 and further in view of Zanakis et al. US 5,433,735 and further in view of Racon De Lima et al. US 2014/0336722.
Regarding claims 6-7: Buckley/Bijelic/Zanakis discloses the claimed invention however Buckley/Bijelic/Zanakis does not specifically disclose a motion for use in the neuroprosthesis with the motions sensor in a housing. Racon De Lima however teaches of a neuroprosthesis which is a wearable garment and includes a motion sensor within a housing (figure 2; the motion sensor is element 2) to detect tremor (paragraphs 0088, 0089 and 00093), the motion sensor is disclosed to be a gyroscope (paragraph 0116-0017 discusses wrist motion), accelerometer (paragraph 0147) or a magnetometer (paragraph 0025). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Buckley/Bijelic/Zanakis to include a motion sensor such as an accelerometer, gyroscope or magnetometer, as taught by Racon De Lima, in order to determine when tremor is present. It is noted that all of the motion sensors discussed in Racon De Lima are measuring motion which would include wrist motion, these devices are inherently configured to measure wrist motion.
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Buckley et al. US 9,332,918 in view of Bijelic et al. US 2008/0027507 and further in view of Zanakis et al. US 5,433,735 and further in view of Heldman et al. US 2014/0074179.
Regarding claims 8-9: Buckley/Bijelic/Zanakis discloses the claimed invention however Buckley/Bijelic/Zanakis does not disclose a rechargeable battery which is inductively chargeable. Heldman however teaches of recharging a battery in a pulse generator using inductive coupling (paragraph 0101). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Buckley/Bijelic/Zanakis to include an inductively chargeable rechargeable battery, as taught by Heldman, in order to allow for charging the system multiple times.
Claims 12-13 and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Lathrop US 2008/0097564 in view of Heldman et al. US 2014/0074179.
Regarding claims 12-13: Lathrop discloses the claimed invention however Lathrop does not disclose the use of a processor which receives cloud data to adjust stimulation parameters using neural networks. Heldman however teaches of cloud based databases for analyzing and further processing data (paragraph 0070). Algorithms and programs can be stored in the cloud (paragraph 0108). Heldman further teaches of using a neural network for parameter adjustment (paragraphs 0051, 0142-0143). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Lathrop to include programs stored in the cloud, including neural networks, as taught by Heldman, to process data and suggest stimulation parameters based on the analysis.
Regarding claims 18-19: Lathrop discloses the claimed invention however Lathrop does not disclose a rechargeable battery which is inductively chargeable. Heldman however teaches of recharging a battery in a pulse generator using inductive coupling (paragraph 0101). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Lathrop to include an inductively chargeable rechargeable battery, as taught by Heldman, in order to allow for charging the system multiple times.
Claims 14-17 are rejected under 35 U.S.C. 103 as being unpatentable over Lathrop US 2008/0097564 in view of Racon De Lima et al. US 2014/0336722.
Regarding claims 14-17: Lathrop discloses the claimed invention however Lathrop does not specifically disclose a motion for use in the neuroprosthesis with the motions sensor in a housing. Racon De Lima however teaches of a neuroprosthesis which is a wearable garment and includes a motion sensor within a housing (figure 2; the motion sensor is element 2) to detect tremor (paragraphs 0088, 0089 and 00093), the motion sensor is disclosed to be a gyroscope (paragraph 0116-0017 discusses wrist motion), accelerometer (paragraph 0147) or a magnetometer (paragraph 0025). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Lathrop to include a motion sensor such as an accelerometer, gyroscope or magnetometer, as taught by Racon De Lima, in order to determine when tremor is present. It is noted that all of the motion sensors discussed in Racon De Lima are measuring motion which would include wrist motion, these devices are inherently configured to measure wrist motion.
Double Patenting
Applicant has the following copending applications:
12,109,413
9,802,041
10,179,38
10,561,839
10,960,207
No double patenting rejections will be made at this time because none of the above issued patents claim a distally placed electrode as is required by both independent claims 1 and 10.
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