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 .
Status of Claims
The amendments and remarks filed on 10OCT2025 have been entered and considered.
Claims 1-5, 8-9, 11, 30-33, & 36-37 are currently pending.
Claims 1-4, 8-9, 11, 30-32 & 36-37 have been amended.
No claims have been added.
New matter has been found in Claims 1 & 11.
Claims 1-5, 8-9, 11, 30-33, & 36-37 are under examination.
Response to Arguments
Applicant's arguments filed 10OCT2025 regarding the rejections under 35 USC 112(b) have been fully considered and have been found to be persuasive. Therefore, the rejections have been withdrawn
Applicant's arguments filed 10OCT2025 regarding the rejections under 35 USC 102(a)(2) using reference Karantonis have been fully considered and have been found to be persuasive. The examiner has entered the disclaimer regarding Karantonis and therefore, the reference has been withdrawn as no longer being applicable as Prior art. Therefore, the rejections have been withdrawn. A new ground for rejection has been made below.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-5, 8-9, 11, 30-33 & 36-37 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.
Regarding Claims 1 & 11:
The specification does not describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. As an example, if the means- (or step-) plus-function limitation is computer-implemented, and the specification does not provide a disclosure of the computer and algorithm in sufficient detail to demonstrate to one of ordinary skill in the art that the inventor possessed the invention , see MPEP § 2161.01. In this case, “wherein an artefact caused by the stimulus arises on the at least one measurement electrode and appears in the response, a magnitude of the artefact varying as a function of a distance between the central stimulation electrode and the at least one measurement electrode; and wherein the tripolar electrical stimuli and a position of the at least one measurement electrode relative to the central stimulation electrode are configured such that a minima region of the artefact magnitude function is substantially co-located with the at least one measurement electrode, whereby the respective portions of the stimulus current carried by the peripheral stimulation electrodes are mismatched in a manner which causes the minima region of the artefact magnitude function to be substantially co-located with the at least one measurement electrode.” Is merely claiming a functional result. The details for achieving this function are not provided, as it is not clear how the result is produced . Therefore, the claims lack a written description.
Claims 2-5 & 8-9 are further rejected for depending upon the rejected claim 1.
Claims 30-33 & 36-37 are further rejected for depending upon the rejected claim 11.
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 1-5, 8-9, 11, 30-33 & 36-37 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.
Regarding Claims 1 & 11:
The claims are unclear regarding how to find the minima region as found in claims 1 & 11. ¶0019 of the Specification discloses the minima region and also states it would correspond to a zero crossing of an artefact. The limitations are therefore unclear about what signal the zero crossing is coming from as ¶0019 does not provide clarity. The claims are not clear about if the value is being constantly detected with a measurement electrode to test before it is placed or detected from another sensor afterwards. For the purpose of examination, the examiner is interpreting this as a value being detected while placing the electrodes.
Claims 2-5 & 8-9 are further rejected for depending upon the rejected claim 1.
Claims 30-33 & 36-37 are further rejected for depending upon the rejected claim 11.
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.
Claims 1-5, 8-9, 11, 30-33, & 36-37 are rejected under 35 U.S.C. 103 as being obvious over Parker (WO Publication No. 2016161484.).
Regarding claims 1 & 11, Parker discloses neurostimulation device (Parker ¶0036 “neurostimulator 100”) comprising: at least three stimulation electrodes configured to deliver tripolar electrical stimuli to neural tissue (Parker ¶0067 “Current sources were configured to produce tripolar stimulation with a central cathode (channel 2) and anodes on each side (channels 1 & 3). “), the at least three stimulation electrodes comprising a central stimulation electrode which carries an entire stimulus current and two peripheral stimulation electrodes which carry two respective portions of the stimulus current of opposite polarity to the central stimulation electrode (Parker ¶0045 “Depending on the polarity of recording, a normal recorded profile may take an inverse form to that shown in Figure 4, i.e. having two negative peaks Nl and N2, and one positive peak PI .”) to maintain charge-balanced stimulation (Parker ¶0038 “Electrode selection module 126 selects a stimulation electrode 2 of electrode array 150 to deliver an electrical current pulse to surrounding tissue including nerve 180, and also selects a return electrode 4 of the array 150 for stimulus current recovery to maintain a zero net charge transfer.”); and at least one measurement electrode configured to record a response of the neural tissue to the stimulus (Parker ¶0067 “Evoked responses were recorded on electrodes 4 to 24.”),
Parker does not explicitly teach wherein an artefact caused by the stimulus arises on the at least one measurement electrode and appears in the response ion and here is my breakdown of claim interretaiton., a magnitude of the artefact varying as a function of a distance between the central stimulation electrode and the at least one measurement electrode; and wherein the tripolar electrical stimuli and a position of the at least one measurement electrode relative to the central stimulation electrode are configured such that a minima region of the artefact magnitude function is substantially co-located with the at least one measurement electrode, whereby the respective portions of the stimulus current carried by the peripheral stimulation electrodes are mismatched in a manner which causes the minima region of the artefact magnitude function to be substantially co-located with the at least one measurement electrode.
It is respectfully submitted that the recitation "wherein an artefact caused by the stimulus arises on the at least one measurement electrode and appears in the response, a magnitude of the artefact varying as a function of a distance between the central stimulation electrode and the at least one measurement electrode; and wherein the tripolar electrical stimuli and a position of the at least one measurement electrode relative to the central stimulation electrode are configured such that a minima region of the artefact magnitude function is substantially co-located with the at least one measurement electrode, whereby the respective portions of the stimulus current carried by the peripheral stimulation electrodes are mismatched in a manner which causes the minima region of the artefact magnitude function to be substantially co-located with the at least one measurement electrode" fails to further define the claimed invention over that of the prior art because it is directed to an intended use recitation. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. MPEP 2103.1.C. The claims do not further limit the methods or structure, and therefore the examiner suggests amendments to the limitations such as to amend the method to positively recite active method steps of “adjusting the position of the electrodes and the stimuli delivered by the electrodes to co-locate the minima region of the artefact magnitude”.
Regarding claims 2-4 & 30-32, Claims 1 & 11 are unpatentable over Parker. Parker does not further disclose wherein the artefact arising upon the at least one measurement electrode is less than 25%-75% of a peak value of artefact magnitude arising in spatial regions more distal from the stimulation electrodes than the at least one measurement electrode. "It is respectfully submitted that the recitation "wherein the artefact arising upon the at least one measurement electrode is less than 25%-75% of a peak value of artefact magnitude arising in spatial regions more distal from the stimulation electrodes than the at least one measurement electrode" fails to further define the claimed invention over that of the prior art because it is directed to an intended use recitation. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations." MPEP 2103.1.C
Regarding claims 5 & 33, Claims 1 & 11 are unpatentable over Parker. Parker does not further disclose wherein the minima region of the artefact magnitude function comprises a zero crossing region of the artefact magnitude function. "It is respectfully submitted that the recitation " wherein the minima region of the artefact magnitude function comprises a zero crossing region of the artefact magnitude function " fails to further define the claimed invention over that of the prior art because it is directed to an intended use recitation. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations." MPEP 2103.1.C
Regarding claims 8 & 36, Claims 1 & 11 are unpatentable over Parker. Parker does not further disclose a system configured to adaptively alter a stimulation ratio, being a ratio between the respective portions of the stimulus current carried by the peripheral stimulation electrodes, depending on the position of the at least one measurement electrode relative to the central stimulation electrode. It is respectfully submitted that the recitation "configured to adaptively alter a stimulation ratio, being a ratio between the respective portions of the stimulus current carried by the peripheral stimulation electrodes, depending on the position of the at least one measurement electrode relative to the central stimulation electrode" fails to further define the claimed invention over that of the prior art because it is directed to an intended use recitation. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. MPEP 2103.1.C.
Regarding claims 9 & 37, Claims 1, 8, 11, & 36 are unpatentable over Parker. Parker further does not disclose the system configured to adaptively alter the stimulation ratio by: delivering a range of stimuli of varying stimulus ratio, at a sub-threshold level which does not recruit a neural response, observing the artefact caused by each such stimulus arising at the at least one measurement electrode, and seeking a stimulus ratio which minimises a magnitude of the artefact observed upon the at least one measurement electrode. It is respectfully submitted that the recitation "configured to adaptively alter the stimulation ratio by: delivering a range of stimuli of varying stimulus ratio, at a sub-threshold level which does not recruit a neural response, observing the artefact caused by each such stimulus arising at the at least one measurement electrode, and seeking a stimulus ratio which minimises a magnitude of the artefact observed upon the at least one measurement electrode" fails to further define the claimed invention over that of the prior art because it is directed to an intended use recitation. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. MPEP 2103.1.C
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEGAN FEDORKY whose telephone number is (571)272-2117. The examiner can normally be reached M-F 9:30-4:30.
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/MEGAN T FEDORKY/
Examiner, Art Unit 3796
/ALLEN PORTER/Primary Examiner, Art Unit 3796