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 .
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 device of claims 9-16 including their features 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.
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 1-16 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.
Claim 1 recites the limitation "A method for applying electrical stimulation to a vagus nerve that is a method for applying electrical stimulation to a vagus nerve through an electrode" in lines 1-3. This limitation is confusing and repetitive. Examiner will interpret as “A method for applying electrical stimulation to a vagus nerve through an electrode” and suggests amending.
Claim 1 recites the limitation "the skin of a human body" in line 4. There is insufficient antecedent basis for this limitation in the claim. Examiner will interpret as "a skin of a human body" and suggests amending.
Claim 1 recites the limitation "on the basis of the derived initial" in line 14. There is insufficient antecedent basis for this limitation in the claim. Examiner will interpret as "on a basis of the derived initial" and suggests amending.
Claims 2-7 are rejected based on their dependency on claim 1.
Claim 8 recites the limitation "on the basis of the impedance" in line 3. There is insufficient antecedent basis for this limitation in the claim. Examiner will interpret as "on a basis of the impedance" and suggests amending.
Claim 9 recites the limitation "the skin of a human body" in line 4. There is insufficient antecedent basis for this limitation in the claim. Examiner will interpret as "a skin of a human body" and suggests amending.
Claims 10-11 are rejected based on their dependency on claim 9.
Claim 12 recites the limitation "on the basis of an input value" in line 8. There is insufficient antecedent basis for this limitation in the claim. Examiner will interpret as "on a basis of an input value" and suggests amending.
Claims 13-15 are rejected based on their dependency on claim 9.
Claim 16 recites the limitation "on the basis of the impedance" in line 3. There is insufficient antecedent basis for this limitation in the claim. Examiner will interpret as "on a basis of the impedance" and suggests amending.
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.
Claim(s) 1-16 are rejected under 35 U.S.C. 103 as being unpatentable over US 2019/0038899 Lo et al., hereinafter “Lo”, in view of US 2021/0283399 Willand et al., hereinafter “Willand”.
Regarding claim 1, Lo discloses a method for applying electrical stimulation to a vagus nerve (Abstract) through an electrode (Figure 2, element 16), the method comprising:
an electrical stimulation guideline input step of inputting an electrical stimulation guideline comprising numerical values for electrical stimulation (Para 46; voltages are programmed for stimulation, voltages are known to be numerical values);
an initial input value derivation step of measuring impedance (Para 46; electrode impedance is measured) and deriving an input value corresponding to the electrical stimulation guideline using the measured impedance before electrical stimulation is applied (Para 46 and 132; based on the stimulation current and the measured impedance, supply voltage is determined, stimulation cannot be applied before voltage is determined); and
an electrical stimulation application step of applying electrical stimulation on a basis of the derived initial input value (Para 46 implies that stimulation is applied at the determined voltage; Para 145 specifically discloses a controller that controls stimulations).
Lo does not specifically disclose an electrode that is in contact with a skin of a human body and measuring impedance between the electrode and the skin.
However, Willand discloses a nerve stimulating device/method (Abstract) and teaches an electrode that is in contact with a skin of a human body (Para 58; “a patch electrode positioned on a skin surface of the subject”) and measuring impedance between the electrode and the skin (Para 66 and 237).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed measuring impedance between the electrode and the skin as taught by Willand, in the invention of Lo, in order to clarify that the skin impedance is being measured (Willand; Para 66 and 237).
Regarding claim 2, Lo discloses the electrical stimulation guideline comprises a current (Para 46; stimulation current), and voltage corresponding to the current included in the electrical stimulation guideline is derived in the initial input value derivation step (Para 46; a voltage is determined based on both the current and the impedance measurement).
Regarding claim 3, Lo discloses all the limitations of claim 2.
Lo does not disclose when the initial input value derived in the initial input value derivation step is larger than a predetermined value, the electrical stimulation application step is not performed.
However, Willand teaches when the initial input value derived in the initial input value derivation step is larger than a predetermined value, the electrical stimulation application step is not performed (Para 239; if the impedance value is detected to be higher than a threshold, then the application of stimulus is paused, can be interpreted to mean not pushed through, i.e. not performed).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed stopping stimulation as taught by Willand, in the invention of Lo, in order to enhance patient safety (Willand; Para 239-240).
Regarding claim 4, Lo discloses an in-stimulation adjustment step of measuring impedance between the electrode and the skin and adjusting an input value corresponding to the electrical stimulation guideline by applying newly measured impedance is performed while the electrical stimulation application step is performed (Para 121; “wherein said bio-impedance characteristics are utilized for controlling the stimulation applied at said electrode array according to one or more stimulation parameters that may be adjusted in real time”).
Regarding claim 5, Lo discloses the electrical stimulation guideline comprises a current (Para 46 and 132), and voltage corresponding to the current comprised in the electrical stimulation guideline is derived in the in-stimulation adjustment step (Para 46, 121, and 132).
Regarding claim 6, Lo discloses all the limitations of claim 5.
Lo does not disclose when the initial input value derived in the in-stimulation adjustment step is larger than a predetermined value, the electrical stimulation application step is stopped.
However, Willand teaches when the initial input value derived in the in-stimulation adjustment step is larger than a predetermined value, the electrical stimulation application step is stopped (Para 239; if the impedance value is detected to be higher than a threshold, then the application of stimulus is paused).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed stopping stimulation as taught by Willand, in the invention of Lo, in order to enhance patient safety (Willand; Para 239-240).
Regarding claim 7, Lo discloses the in-stimulation adjustment step is performed with a predetermined interval (Para 121; the predetermined interval is in real-time, examiner suggests defining the interval to overcome this reference).
Regarding claim 8, Lo discloses an interval at which a latter in-stimulation voltage adjustment step is performed is changed on a basis of the impedance measured in the in- stimulation adjustment step (Para 45-46 and 121; the term “interval” here is very broad. Para 121 discloses “said bio-impedance characteristics are utilized for controlling the stimulation applied at said electrode array according to one or more stimulation parameters that may be adjusted in real time”. Real time here means at any given moment from when the impedance has varied. This is going to be a different interval than the previous interval in the in-stimulation adjustment step. Any time an impedance has changed, at random intervals, the stimulation will be adjusted in real time. Examiner suggests further defining what “an interval” stands for here and how it compares to the predetermined interval in claim 7).
Regarding claim 9, Lo discloses a device for applying electrical stimulation to a vagus nerve (Abstract and Figure 2), the device comprising:
an electrode (Figure 2, element 16)
an input unit configured to receive an electrical stimulation guideline comprising numerical values for electrical stimulation (Figure 3A, element 48 and Para 46; voltages are programmed for stimulation, voltages are known to be numerical values);
an initial input value deriver configured to measure (Para 46; electrode impedance is measured; Figure 2, element 16) and derives an input value corresponding to the electrical stimulation guideline using the measured impedance before electrical stimulation is applied (Para 46 and 132; based on the stimulation current and the measured impedance, supply voltage is determined, stimulation cannot be applied before voltage is determined); and
a controller configured to perform control such that the input value derived by the initial input value deriver is applied to the electrode (Para 46, 121, and 145).
Lo does not specifically disclose an electrode configured to apply electrical stimulation in contact with a skin of a human body and measure impedance between the electrode and the skin.
However, Willand discloses a nerve stimulating device/method (Abstract) and teaches an electrode configured to apply electrical stimulation in contact with a skin of a human body (Para 58; “a patch electrode positioned on a skin surface of the subject” and 339; “the built-in stimulus generator within the patch is activated by pressing a switch or other controller”) and measure impedance between the electrode and the skin (Para 66 and 237).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed measuring impedance between the electrode and the skin as taught by Willand, in the invention of Lo, in order to clarify that the skin impedance is being measured (Willand; Para 66 and 237).
Regarding claim 10, Lo discloses the electrical stimulation guideline comprises a current (Para 46; stimulation current), and the initial input value deriver derives voltage corresponding to the current comprised in the electrical stimulation guideline (Para 46; a voltage is determined based on both the current and the impedance measurement).
Regarding claim 11, Lo discloses all the limitations of claim 10.
Lo does not disclose when the initial input value derived by the initial input value deriver is larger than a predetermined value, the controller does not apply electrical stimulation to the electrode.
However, Willand teaches when the initial input value derived by the initial input value deriver is larger than a predetermined value, the controller does not apply electrical stimulation to the electrode (Para 239; if the impedance value is detected to be higher than a threshold, then the application of stimulus is paused, can be interpreted to mean not pushed through, i.e. not performed).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed stopping stimulation as taught by Willand, in the invention of Lo, in order to enhance patient safety (Willand; Para 239-240).
Regarding claim 12, Lo discloses an in- stimulation input value deriver configured to measure impedance between the electrode and the skin with electrical stimulation applied to the electrode and derive voltage corresponding to the electrical stimulation guideline by reflecting the newly measured impedance, wherein the controller can apply electrical stimulation on a basis of an input value derived by the in-stimulation input value deriver (Para 121; “wherein said bio-impedance characteristics are utilized for controlling the stimulation applied at said electrode array according to one or more stimulation parameters that may be adjusted in real time”).
Regarding claim 13, Lo discloses the electrical stimulation guideline comprises a current (Para 46 and 132), and the in- stimulation input value deriver derives voltage corresponding to the current comprised in the electrical stimulation guideline (Para 46, 121, and 132).
Regarding claim 14, Lo discloses all the limitations of claim 13.
Lo does not disclose when the voltage derived by the in-stimulation input value deriver is larger than a predetermined value, the controller does not apply electrical stimulation to the electrode.
However, Willand teaches when the voltage derived by the in-stimulation input value deriver is larger than a predetermined value, the controller does not apply electrical stimulation to the electrode (Para 239; if the impedance value is detected to be higher than a threshold, then the application of stimulus is paused).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed stopping stimulation as taught by Willand, in the invention of Lo, in order to enhance patient safety (Willand; Para 239-240).
Regarding claim 15, Lo discloses the in-stimulation input value deriver measures impedance between the electrode and the skin with a predetermined interval (Para 121; the predetermined interval is in real-time, examiner suggests defining the interval to overcome this reference).
Regarding claim 16, Lo discloses an interval at which impedance between the electrode and the skin is measured later is changed on a basis of the impedance measured by the in-stimulation input value deriver (Para 45-46 and 121).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AYA ZIAD BAKKAR whose telephone number is (313)446-6659. The examiner can normally be reached on 7:30 am - 5:00 pm M-Th.
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/AYA ZIAD BAKKAR/
Examiner, Art Unit 3796
/TAMMIE K MARLEN/Primary Examiner, Art Unit 3796
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