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 .
Response to Amendment
Claims 1-15 are currently pending. Claims 6-15 remain withdrawn. Claims 1, 2, and 5 have been amended.
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 near a phrenic nerve to allow stimulation of the phrenic nerve at a nerve depth. 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 near a phrenic nerve to allow stimulation of the phrenic nerve at a nerve depth;
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 at the nerve depth
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 displaying a treatment plan for phrenic nerve stimulation of the patient, based on the determined integrity, which is merely adding insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)). The displaying of the treatment plan for phrenic nerve stimulation of the patient, based on the determined integrity 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 displayed treatment plan for phrenic nerve stimulation of the patient, 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 at the nerve depth; 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 [0028] of Casavant et al. ‘015 (US Pub No. 2004/0088015)). 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 – previously cited) in view of Walker et al. ‘790 (US Pub No. 2004/0122790 – previously cited) further in view of Miller et al. ‘306 (US Pub No. 2023/0071306, provisional date 21 February 2020).
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 near a phrenic nerve to allow stimulation of the phrenic nerve at a nerve depth (Fig. 1 electrodes 24 and [0035], [0038]);
emitting a nerve stimulation pulse from the set of electrodes to stimulate the phrenic nerve at the nerve depth (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 at the nerve depth ([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.
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 displaying a treatment plan for phrenic nerve stimulation of the patient, based on the determined integrity.
Miller et al. ’306 teaches displaying a treatment plan based on the model or updated model, and empirical data of ablation size, depth, and power requirements are correlated with tissue type and type of anatomical target (e.g., tumor or other hyperplastic tissue) (Fig. 3 process 355 and [0067]-[0068]).
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 in view of Walker et al. ‘790 to include displaying a treatment plan for phrenic nerve stimulation of the patient, based on the determined integrity as Miller et al. ‘306 teaches that this would aid in planning a medical procedure that includes determining a navigational path to an anatomic or ablation target and/or creating a treatment plan ([0062]).
Regarding claim 5, Hareland et al. ‘028, as modified by Walker et al. ‘790 and Miller et al. ‘306, teaches wherein determining the integrity of the phrenic nerve at the nerve depth 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 Miller et al. ‘306 further in view of Wahlgren et al. ‘149 (US Pub No. 2009/0157149 – previously cited).
Regarding claim 2, Hareland et al. ‘028 teaches wherein the nerve depth is a first nerve depth (The phrenic nerve is at a depth of a person’s body, which is interpreted as the first nerve depth.), and 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 further in view of Miller et al. ‘306 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 further in view of Miller et al. ‘306 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, Miller et al. ‘306, 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.
Response to Arguments
Applicant’s arguments, see page 7 of Remarks, filed 02 July 2026, with respect to claim 1 have been fully considered and are persuasive. The 35 U.S.C. 112(b) rejection of claim 1 has been withdrawn.
Applicant argues that claim 1 recites positioning electrodes in a body of a patient, providing nerve stimulation from within a patient’s body, and displaying a treatment plan based on determined nerve integrity. However, the positioning step is organizing human activity as a healthcare professional could be instructed to position the electrodes in a patient. Furthermore, there is no recitation that this step is performed by a machine. The step of providing stimulation is an additional element and is a pre-solutional step of data gathering necessary to perform the Abstract Idea. Applicant also argues that the recitation of displaying a treatment plan is a particular treatment or effects a particular change. However, the step of displaying a treatment plan is not a particular treatment. Rather, this step is merely displaying a treatment plan rather than actually carrying out the treatment. Section 2106.04(d)(2) of the MPEP states that “…in order to qualify as a "treatment" or "prophylaxis" limitation for purposes of this consideration, the claim limitation in question must affirmatively recite an action that effects a particular treatment or prophylaxis for a disease or medical condition.” As such, Applicant’s arguments are not persuasive and the 35 U.S.C. 101 rejection has been maintained.
Applicant’s arguments with respect to the 35 U.S.C. 103 rejections have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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
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