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 .
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.
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 1-19 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 ‘an evoked neural response signal’ after reciting ‘a neural response’ making it unclear if each recitation is meant to refer to the same element or not.
Claim 2 recites ‘a sense electrode’ and is dependent back to claim 1 which recites the same, making it unclear if the recitation in claim 1 is meant to refer to that in claim 1 or not.
Claim 6 recites the limitation "the settling, recovering, applying, and amplifying" in Line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 6 recites ‘a measurement cycle’ and then later ‘multiple measurement cycles’ and it is unclear whether the initial recitation is part of the latter recitation or not.
Claim 6 recites ‘each measurement cycle’ and it is unclear if this is part of the ‘multiple measurement cycles’ as earlier recited or not.
The term “approximately” in claim 15 is a relative term which renders the claim indefinite. The term “approximately” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim 17 recites the term ‘an electrical stimulus’ twice in the claim making it unclear if each recitation refers to the same element or not.
Claim 17 recites ‘an evoked neural response signal’ after reciting ‘a neural response’ making it unclear if each recitation is meant to refer to the same element or not.
Claim 17 recites the term ‘an evoked neural response signal’ twice in the claim making it unclear if each recitation refers to the same element or not.
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.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 9386934.
The similarities between the rejected claims of the instant application and patented claims can be seen in the chart below.
The difference between the rejected claims of the instant application and patented claims of the patent lies in the fact that the patented claims are more specific. Thus, the invention of patented claims is in effect a “species” of the “generic” invention of rejected claims. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
The only other difference is that the patent does not teach the implantable device the only structures not taught by the patent are the implantable device and control unit aspects each of which would have been obvious to one of ordinary skill in the art to implement since it requires routine experimentation and would yield predictable results.
Instant Application 19/005,750
Conflicting US Patent No. 9386934
1. A method for measuring a neural response to an electrical stimulus, the method comprising:
recovering charge on a plurality of stimulus electrodes by short circuiting each electrode of the plurality of stimulus electrodes to each other electrode of the plurality of stimulus electrodes;
applying the electrical stimulus from the plurality of stimulus electrodes to neural tissue while a sense electrode is disconnected from measurement circuitry; and
amplifying an evoked neural response signal present at the sense electrode by connecting the sense electrode to the measurement circuitry.
1. A method for measuring a neural response to a stimulus, the method comprising:
settling measurement circuitry prior to a stimulus, by connecting a sense electrode to the measurement circuitry to allow the measurement circuitry to settle towards a bio-electrically defined steady state;
recovering charge on stimulus electrodes by short circuiting the stimulus electrodes to each other;
applying an electrical stimulus from the stimulus electrodes to neural tissue, while keeping the sense electrode disconnected from the measurement circuitry;
imposing a delay during which the stimulus electrodes are open circuited and the sense electrode is disconnected from the measurement circuitry and from the stimulus electrodes; and
after the delay, measuring a neural response signal present at the sense electrode by connecting the sense electrode to the measurement circuitry.
17. An implantable device for measuring a neural response to an electrical stimulus, the device comprising:
a plurality of electrodes including a plurality of stimulus electrodes and one or more sense electrodes;
a stimulus source configured to provide an electrical stimulus from the plurality of stimulus electrodes to neural tissue;
measurement circuitry configured to amplify an evoked neural response signal sensed at the one or more sense electrodes; and
a control unit configured to control application of the electrical stimulus to the neural tissue and measurement of an evoked neural response signal, the control unit configured to:
recover charge on the plurality of stimulus electrodes by short circuiting the plurality of stimulus electrodes to each other;
cause the stimulus source to provide the electrical stimulus from the plurality of stimulus electrodes to the neural tissue, while keeping the one or more sense electrodes disconnected from the measurement circuitry; and
amplify an evoked neural response signal present at the one or more sense electrodes by connecting the one or more sense electrodes to the measurement circuitry.
1. A method for measuring a neural response to a stimulus, the method comprising:
settling measurement circuitry prior to a stimulus, by connecting a sense electrode to the measurement circuitry to allow the measurement circuitry to settle towards a bio-electrically defined steady state;
recovering charge on stimulus electrodes by short circuiting the stimulus electrodes to each other;
applying an electrical stimulus from the stimulus electrodes to neural tissue, while keeping the sense electrode disconnected from the measurement circuitry;
imposing a delay during which the stimulus electrodes are open circuited and the sense electrode is disconnected from the measurement circuitry and from the stimulus electrodes; and
after the delay, measuring a neural response signal present at the sense electrode by connecting the sense electrode to the measurement circuitry.
Claims 1-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 10278600.
The similarities between the rejected claims of the instant application and patented claims can be seen in the chart below.
The difference between the rejected claims of the instant application and patented claims of the patent lies in the fact that the patented claims are more specific. Thus, the invention of patented claims is in effect a “species” of the “generic” invention of rejected claims. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). The patent does not specifically disclose a method but each step of the method is disclosed as part of the functions of the device of the patent being performed by the control unit. Since rejected claims are anticipated by patented claims, it is not patentably distinct from patented claims.
Instant Application 19/005,750
Conflicting US Patent No. 10278600
1. A method for measuring a neural response to an electrical stimulus, the method comprising:
recovering charge on a plurality of stimulus electrodes by short circuiting each electrode of the plurality of stimulus electrodes to each other electrode of the plurality of stimulus electrodes;
applying the electrical stimulus from the plurality of stimulus electrodes to neural tissue while a sense electrode is disconnected from measurement circuitry; and
amplifying an evoked neural response signal present at the sense electrode by connecting the sense electrode to the measurement circuitry.
1. An implantable device for measuring a neural response to a stimulus, the device comprising:
a plurality of electrodes including at least one nominal stimulus electrode and at least one nominal sense electrode;
a stimulus source for providing a stimulus to be delivered from the one or more stimulus electrodes to neural tissue;
measurement circuitry for amplifying a neural signal sensed at the one or more sense electrodes; and
a control unit configured to control application of a stimulus to the neural tissue and measurement of an evoked neural response, the control unit configured
to settle the measurement circuitry prior to a stimulus by connecting the at least one sense electrode to the measurement circuitry to allow the measurement circuitry to settle towards a bio-electrically defined steady state,
the control unit further configured to recover charge on the stimulus electrodes by short circuiting the stimulus electrodes to each other,
the control unit further configured to cause the stimulus source to apply an electrical stimulus from the stimulus electrodes to neural tissue while keeping the at least one sense electrode disconnected from the measurement circuitry,
the control unit further configured to impose a delay during which the stimulus electrodes are open circuited and the sense electrode is disconnected from the measurement circuitry and from the stimulus electrodes, and
the control unit further configured to measure a neural response signal present at the sense electrode by connecting the at least one sense electrode to the measurement circuitry after the delay.
17. An implantable device for measuring a neural response to an electrical stimulus, the device comprising:
a plurality of electrodes including a plurality of stimulus electrodes and one or more sense electrodes;
a stimulus source configured to provide an electrical stimulus from the plurality of stimulus electrodes to neural tissue;
measurement circuitry configured to amplify an evoked neural response signal sensed at the one or more sense electrodes; and
a control unit configured to control application of the electrical stimulus to the neural tissue and measurement of an evoked neural response signal, the control unit configured to:
recover charge on the plurality of stimulus electrodes by short circuiting the plurality of stimulus electrodes to each other;
cause the stimulus source to provide the electrical stimulus from the plurality of stimulus electrodes to the neural tissue, while keeping the one or more sense electrodes disconnected from the measurement circuitry; and
amplify an evoked neural response signal present at the one or more sense electrodes by connecting the one or more sense electrodes to the measurement circuitry.
1. An implantable device for measuring a neural response to a stimulus, the device comprising:
a plurality of electrodes including at least one nominal stimulus electrode and at least one nominal sense electrode;
a stimulus source for providing a stimulus to be delivered from the one or more stimulus electrodes to neural tissue;
measurement circuitry for amplifying a neural signal sensed at the one or more sense electrodes; and
a control unit configured to control application of a stimulus to the neural tissue and measurement of an evoked neural response, the control unit configured
to settle the measurement circuitry prior to a stimulus by connecting the at least one sense electrode to the measurement circuitry to allow the measurement circuitry to settle towards a bio-electrically defined steady state,
the control unit further configured to recover charge on the stimulus electrodes by short circuiting the stimulus electrodes to each other,
the control unit further configured to cause the stimulus source to apply an electrical stimulus from the stimulus electrodes to neural tissue while keeping the at least one sense electrode disconnected from the measurement circuitry,
the control unit further configured to impose a delay during which the stimulus electrodes are open circuited and the sense electrode is disconnected from the measurement circuitry and from the stimulus electrodes, and
the control unit further configured to measure a neural response signal present at the sense electrode by connecting the at least one sense electrode to the measurement circuitry after the delay.
Claims 1-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 11324427.
The similarities between the rejected claims of the instant application and patented claims can be seen in the chart below.
The difference between the rejected claims of the instant application and patented claims of the patent lies in the fact that the patented claims are more specific. Thus, the invention of patented claims is in effect a “species” of the “generic” invention of rejected claims. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since rejected claims are anticipated by patented claims, it is not patentably distinct from patented claims.
Instant Application 19/005,750
Conflicting US Patent No. 11324427
1. A method for measuring a neural response to an electrical stimulus, the method comprising:
recovering charge on a plurality of stimulus electrodes by short circuiting each electrode of the plurality of stimulus electrodes to each other electrode of the plurality of stimulus electrodes;
applying the electrical stimulus from the plurality of stimulus electrodes to neural tissue while a sense electrode is disconnected from measurement circuitry; and
amplifying an evoked neural response signal present at the sense electrode by connecting the sense electrode to the measurement circuitry.
1. A method of measuring a neural response evoked by a stimulus, the method comprising:
applying the stimulus to neural tissue;
during the applying of the stimulus, disconnecting electrode segments of a sense electrode so as to limit disequilibrium arising on the sense electrode to each of the electrode segments; and
measuring a neural response evoked by the stimulus in a neural signal sensed at the sense electrode by connecting the electrode segments to each other, and
connecting the sense electrode to measurement circuitry.
17. An implantable device for measuring a neural response to an electrical stimulus, the device comprising:
a plurality of electrodes including a plurality of stimulus electrodes and one or more sense electrodes;
a stimulus source configured to provide an electrical stimulus from the plurality of stimulus electrodes to neural tissue;
measurement circuitry configured to amplify an evoked neural response signal sensed at the one or more sense electrodes; and
a control unit configured to control application of the electrical stimulus to the neural tissue and measurement of an evoked neural response signal, the control unit configured to:
recover charge on the plurality of stimulus electrodes by short circuiting the plurality of stimulus electrodes to each other;
cause the stimulus source to provide the electrical stimulus from the plurality of stimulus electrodes to the neural tissue, while keeping the one or more sense electrodes disconnected from the measurement circuitry; and
amplify an evoked neural response signal present at the one or more sense electrodes by connecting the one or more sense electrodes to the measurement circuitry.
9. An implantable device for measuring a neural response evoked by a stimulus, the implantable device comprising:
a plurality of electrodes including one or more stimulus electrodes and one or more sense electrodes, wherein at least one of the one or more sense electrodes comprises at least two sense electrode segments;
one or more stimulus sources for providing the stimulus to be delivered from the one or more stimulus electrodes to neural tissue;
measurement circuitry for amplifying a neural signal sensed at the one or more sense electrodes; and
a control unit configured to:
disconnect the at least two sense electrode segments during delivery of the stimulus, so as to limit disequilibrium arising on the at least one of the one or more sense electrodes to each sense electrode segment of the at least two sense electrode segments;
control the one or more stimulus sources to provide the stimulus to be delivered to the neural tissue;
connect the at least two sense electrode segments to each other and connect the at least one of the one or more sense electrodes to the measurement circuitry; and measure the neural response evoked by the stimulus in the amplified neural signal.
Claims 1-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 12257056 in view of Baru Fassio et al. (US 2005/0010265). The similarities between the rejected claims of the instant application and patented claims can be seen in the chart below. The patent does not disclose the recovering of charge through short circuiting. Baru Fassio discloses the recovering of charge through short circuiting (Paragraph 0056). And it would have been obvious to one of ordinary skill in the art to have modified the patent with Baru Fassio because it would yield predictable results and would protect against single failure (Paragraph 0056 of Baru Fassio).
Instant Application 19/005,750
Conflicting US Patent No. 12257056
1. A method for measuring a neural response to an electrical stimulus, the method comprising:
recovering charge on a plurality of stimulus electrodes by short circuiting each electrode of the plurality of stimulus electrodes to each other electrode of the plurality of stimulus electrodes;
applying the electrical stimulus from the plurality of stimulus electrodes to neural tissue while a sense electrode is disconnected from measurement circuitry; and
amplifying an evoked neural response signal present at the sense electrode by connecting the sense electrode to the measurement circuitry.
1. A method for measuring a neural response to an electrical stimulus, the method comprising:
applying the electrical stimulus from stimulus electrodes to neural tissue, while keeping a sense electrode disconnected from measurement circuitry;
imposing, after applying the electrical stimulus, a post-stimulus delay during which the sense electrode is kept disconnected from the measurement circuitry; and
amplifying, after the post-stimulus delay, a neural response signal present at the sense electrode by connecting the sense electrode to the measurement circuitry.
17. An implantable device for measuring a neural response to an electrical stimulus, the device comprising:
a plurality of electrodes including a plurality of stimulus electrodes and one or more sense electrodes;
a stimulus source configured to provide an electrical stimulus from the plurality of stimulus electrodes to neural tissue;
measurement circuitry configured to amplify an evoked neural response signal sensed at the one or more sense electrodes; and
a control unit configured to control application of the electrical stimulus to the neural tissue and measurement of an evoked neural response signal, the control unit configured to:
recover charge on the plurality of stimulus electrodes by short circuiting the plurality of stimulus electrodes to each other;
cause the stimulus source to provide the electrical stimulus from the plurality of stimulus electrodes to the neural tissue, while keeping the one or more sense electrodes disconnected from the measurement circuitry; and
amplify an evoked neural response signal present at the one or more sense electrodes by connecting the one or more sense electrodes to the measurement circuitry.
22. An implantable device for measuring a neural response to an electrical stimulus, the device comprising:
a plurality of electrodes including a plurality of stimulus electrodes and one or more sense electrodes;
a stimulus source configured to provide the electrical stimulus to be delivered from the plurality of stimulus electrodes to neural tissue;
measurement circuitry configured to amplify a neural response signal sensed at the one or more sense electrodes; and
a control unit configured to control application of the electrical stimulus to the neural tissue and measurement of the neural response, the control unit configured to:
cause the stimulus source to apply the electrical stimulus from the plurality of stimulus electrodes to the neural tissue while keeping the one or more sense electrodes disconnected from the measurement circuitry;
impose, after applying the electrical stimulus, a post-stimulus delay during which the one or more sense electrodes are disconnected from the measurement circuitry; and
amplify, after the post-stimulus delay, the neural response signal present at the one or more sense electrodes by connecting the one or more sense electrodes to the measurement circuitry.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Frei et al (US 2004/0133120)
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/PATRICK FERNANDES/Primary Examiner, Art Unit 3791
