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 .
Election/Restrictions
Applicant's election with traverse of claims 1-5 in the reply filed on 21 January 2026 is acknowledged. The traversal is on the ground(s) that separate classification of the subject matter is not conclusive and that the entire application must be examined as a whole when there would not be a serious burden on the Examiner. This is not found persuasive because when comparing the subject matter of claims 1 and 6 to the subject matter of claim 11, claim 11 recites a method of ramping up nerve stimulation by providing stimulation pulses with a particular voltage. Not only is this not recited in claims 1 and 6, but claim 11 also does not determine phrenic nerve activity. Thus, this would be a serious search burden on the Examiner. Regarding claims 1 and 6, although the subject matter of claims 1 and 6 are similar, except for the recitation of determining treatment information in claim 6, it is noted that the dependent claims of claim 1 recite placing the electrodes at a particular nerve depth and determining nerve damage at a location of at least one branch of the phrenic nerve whereas the dependent claims of claim 6 recite placing the electrodes at a particular nerve depth and determining a combined integrity of a first phrenic nerve and second phrenic nerve to determining the treatment information based on the combined integrity, which would also be a search burden. Thus, claims 1-5 are classified in A61B5/388, which is for nerve conduction studying, claims 6-10 are classified in A61B6/506, which is for the diagnosis of nerves, and claims 11-15 are classified in A61B5/294, which is for nerve conduction studying using bioelectric electrodes.
The requirement is still deemed proper and is therefore made FINAL.
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.
Claim 1 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. Claims 2-5 are further rejected due to their dependency to claim 1.
The term “near” in claim 1 is a relative term which renders the claim indefinite. The term “near” 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. It is unclear how close “near a phrenic nerve” is. Clarification is requested.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-5 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claim 1 follows.
STEP 1
Regarding claim 1, the claim recites a series of steps or acts, including positioning a set of electrodes inside a body of a patient at a location near a phrenic nerve. Thus, the claim is directed to a process, which is one of the statutory categories of invention.
STEP 2A, PRONG ONE
The claim is then analyzed to determine whether it is directed to any judicial exception. The steps of:
positioning a set of electrodes inside a body of a patient at a location near a phrenic nerve;
measuring a return signal band between the first signal and the last signal; and
based on the return signal band, determining an integrity of the phrenic nerve
set forth a judicial exception. The positioning step describes managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules and instructions). Thus, the claim is drawn to Organizing Human Activity, which is an Abstract Idea. The measuring and determining steps describe a concept performed in the human mind (including an observation, evaluation, judgment, opinion). Thus, the claim is drawn to a Mental Process, which is also an Abstract Idea.
STEP 2A, PRONG TWO
Next, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claim fails to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. Claim 1 recites based on the return signal band, determining an integrity of the phrenic nerve, which is merely adding insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)). The determining of an integrity of the phrenic nerve does not provide an improvement to the technological field, the method does not effect a particular treatment or effect a particular change based on the determined integrity of the phrenic nerve, nor does the method use a particular machine to perform the Abstract Idea.
STEP 2B
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the Abstract Idea, the claim recites additional steps of:
emitting a nerve stimulation pulse from the set of electrodes to stimulate the phrenic nerve; and
receiving, at the set of electrodes, a return signal based on the nerve stimulation pulse, the return signal having a first signal and a last signal.
The emitting and receiving steps are well-understood, routine and conventional activities for those in the field of medical diagnostics (see 35 U.S.C. 103 rejection below). Further, the emitting and receiving steps are each recited at a high level of generality such that it amounts to insignificant presolution activity, e.g., mere data gathering step necessary to perform the Abstract Idea. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional step that distinguishes it from well-understood, routine, and conventional data gathering and comparing activity engaged in by medical professionals prior to Applicant's invention. Furthermore, it is well established that the mere physical or tangible nature of additional elements such as the obtaining and comparing steps do not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int'l, 134 S.Ct. 2347, 2358-59 (2014)).
Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. Unlike the eligible claim in Diehr in which the elements limiting the exception are individually conventional, but taken together act in concert to improve a technical field, the claim here does not provide an improvement to the technical field. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claim as a whole does not amount to significantly more than the exception itself. The claim is therefore drawn to non-statutory subject matter.
The dependent claims also fail to add something more to the abstract independent claims. Claims 2, 3, and 5 recite steps that add to the Abstract Idea. Claims 4 merely recites where the set of electrodes are positioned, which does not add anything significantly more. The steps recited in the independent claims maintain a high level of generality even when considered in combination with the dependent claims.
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 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Hareland et al. ‘028 (US Pub No. 2021/0313028) in view of Walker et al. ‘790 (US Pub No. 2004/0122790).
Regarding claim 1, Hareland et al. ‘028 teaches a method for determining phrenic nerve integrity (Abstract), the method comprising:
positioning a set of electrodes inside a body of a patient at a location near a phrenic nerve (Fig. 1 electrodes 24 and [0035], [0038]);
emitting a nerve stimulation pulse from the set of electrodes to stimulate the phrenic nerve (Fig. 3 step 100 and [0038]);
receiving, at the set of electrodes, a return signal based on the nerve stimulation pulse (Fig. 3 step 102 and [0038]); and
based on the return signal band, determining an integrity of the phrenic nerve ([0038]; “the phrenic nerve may be monitored for collateral damage”).
Hareland et al. ‘028 teaches all of the elements of the current invention as mentioned above except for the return signal having a first signal and a last signal;
measuring a return signal band between the first signal and the last signal; and
based on the return signal band, determining an integrity of the phrenic nerve.
Walker et al. ‘790 teaches in a nerve conduction study, a charge-emitting electrode is placed over a nerve to be tested and a recording electrode is placed over the muscle controlled by the nerve. Electrical impulses are repeatedly administered to the nerve and the conduction velocity, or time required to obtain muscle response, is then recorded. A comparison of response times may be made between corresponding muscles on different sides of the body. The nerve conduction study may be performed, as noted above, to detect and evaluate damage to the peripheral nervous system, to identify causes of abnormal sensations, to diagnose post-polio syndrome, as well as to evaluate other symptoms ([0104]). One of ordinary skill would understand to determine the response times would require a start signal and a last signal.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Hareland et al. ‘028 to include the return signal having a first signal and a last signal; measuring a return signal band between the first signal and the last signal; and based on the return signal band, determining an integrity of the phrenic nerve as Walker et al. ‘790 teaches that this would aid in evaluating damage to the peripheral nervous system, identifying causes of abnormal sensations, diagnosing post-polio syndrome, as well as to evaluate other symptoms.
Regarding claim 5, Hareland et al. ‘028, as modified by Walker et al. ‘790, teaches wherein determining the integrity of the phrenic nerve includes determining, based on the return signal band, that nerve damage is located along at least one branch of the phrenic nerve (One of ordinary skill would understand that if the phrenic nerve is being stimulated, as mentioned in [0038] of Hareland et al. ‘028, collateral damage may be found along the branch of the phrenic nerve.).
Claims 2-4 are rejected under 35 U.S.C. 103 as being unpatentable over Hareland et al. ‘028 in view of Walker et al. ‘790 further in view of Wahlgren et al. ‘149 (US Pub No. 2009/0157149).
Regarding claim 2, Hareland et al. ‘028 teaches wherein positioning the set of electrodes inside the body includes:
placing the set of electrodes at a first nerve depth of the phrenic nerve (Fig. 1 electrodes 24 and [0035], [0038]); and
placing the set of electrodes at a second nerve depth of the phrenic nerve (Fig. 1 ECG electrodes 26 and [0036], [0038]; It is noted that “nerve depth” is interpreted as a distance from a nerve.).
Walker et al. ‘790 teaches measuring a first time lapse value between the nerve stimulation pulse and the first signal of the return signal ([0104]); and
measuring a second time lapse value between the nerve stimulation pulse and the first signal of the return signal ([0104].
Hareland et al. ‘028 in view of Walker et al. ‘790 teaches all of the elements of the current invention as mentioned above except for wherein positioning the set of electrodes inside the body further includes:
measuring a first time lapse value between the nerve stimulation pulse and the first signal of the return signal at the first nerve depth, wherein the first time lapse value is less than a threshold value; and
measuring a second time lapse value between the nerve stimulation pulse and the first signal of the return signal at the second nerve depth, wherein the second time lapse value is at least the threshold value.
Wahlgren et al. ‘149 teaches "bathing" the entire depth of a nerve, which reduces the current required to stimulate the root nerve. This is because the aggregate effect of stimulating the outer nerve branches (e.g. afferent nerves) at various depths effectively lowers the threshold needed to stimulate the root nerve. As a result, effective root nerve stimulation may be achieved while using less power than would normally be required using prior art devices and methods ([0056]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the positioning of the set of electrodes inside the body of Hareland et al. ‘028 in view of Walker et al. ‘790 to include measuring a first time lapse value between the nerve stimulation pulse and the first signal of the return signal at the first nerve depth, wherein the first time lapse value is less than a threshold value; and measuring a second time lapse value between the nerve stimulation pulse and the first signal of the return signal at the second nerve depth, wherein the second time lapse value is at least the threshold value as Wahlgren et al. ‘149 teaches that this will aid in reducing current required to stimulate the nerve thereby using less power than would be normally required.
Regarding claim 3, Hareland et al. ‘028, as modified by Walker et al. ‘790 and Wahlgren et al. ‘149 teaches based on the first time lapse and the second time lapse ([0104] of Walker et al. ‘790), determining a presence of nerve damage of the phrenic nerve ([0038] of Hareland et al. ‘028) between the first nerve depth and the second nerve depth ([0056] of Wahlgren et al. ‘149).
Regarding claim 4, Hareland et al. ‘028 teaches wherein the set of electrodes is positioned inside of a vein ([0035]; “vasculature”) or an esophagus of the patient.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AURELIE H TU whose telephone number is (571)272-8465. The examiner can normally be reached [M-F] 7:30-3:30.
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/AURELIE H TU/ Primary Examiner, Art Unit 3791