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 1-18 in the reply filed on 05 November 2025 is acknowledged. The traversal is on the ground(s) that the search and examination of all currently pending claims would not pose an undue burden on the Examiner. This is found persuasive as after reconsideration, the Examiner agrees that all pending claims would not pose an undue burden. As such, the Examiner will examine all currently pending claims 1-33.
Claim Objections
Claims 15, 16, and 31 are objected to because of the following informalities:
“the maximum” in line 3 of claim 15 should read as “a maximum”
“the peak of the stimulus to the peak” in line 4 of claim 15 should read as “a peak of a stimulus to a peak”
“the mean” in line 1 of claim 16 should read as “a mean”
“the maximum” in line 3 of claim 31 should read as “a maximum”
“the peak of the stimulus to the peak” in line 4 of claim 31 should read as “a peak of a stimulus to a peak”
“the mean” in line 6 of claim 31 should read as “a mean”
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “delivering means” in claims 1, 6, and 12.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
“delivering means” is interpreted as “a probe” as mentioned in [0017] of the PGPUB
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 2 and 6 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. Claims 3-5 and 8-12 are further rejected to their dependency to claim 2 or 6.
Claim 2 recites the limitation “the light source” in line 1. There is insufficient antecedent basis for this limitation in the claim. “Light source” was not previously recited in claim 1 and it is unclear what this limitation is referring to. It is unclear if this limitation is referring to “optical source” as mentioned in line 3 of claim 1. Clarification is requested.
Claim 6 recites “wherein the delivering means is adapted for delivering the light directly to the target nerve at a distance away from the surface of the target nerve” in lines 1-2. It is unclear what it means for the delivering means to directly deliver light to the target nerve but also be “at a distance away” from the surface of the target nerve. 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 1-33 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 structural elements, including an optical source. Thus, the claim is directed to a machine, 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 step of recording evoked signals responsive to the stimulation for intraoperatively monitoring of the target nerve sets forth a judicial exception. This step describes a concept performed in the human mind (including an observation, evaluation, judgment, opinion). Thus, the claim is drawn to a Mental Process, which is 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 11 recites recording evoked signals responsive to the stimulation for intraoperatively monitoring of the target nerve, which is merely adding insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)). The recording of the evoked signals 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 recorded evoked signals, 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 an optical source configured to generate light; and a delivering means coupled to the optical source to deliver the generated light to a target nerve of the living subject for stimulating the target nerve. Generating light and delivering the generated light is well-understood, routine and conventional activity for those in the field of medical diagnostics. Further, the generating and delivering 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 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 same rationale applies to claim 19.
Regarding claim 1, the device recited in the claim is a generic device comprising generic components configured to perform the abstract idea. The recited optical source and delivering means are a generic components configured to perform pre-solutional data gathering activity and the detector is configured to perform the Abstract Idea. According to section 2106.05(f) of the MPEP, merely using a computer as a tool to perform an abstract idea does not integrate the Abstract Idea into a practical application.
The dependent claims also fail to add something more to the abstract independent claims. Claims 2-5, 7-13, 18, 20-22, 24-29, and 33 recite additional elements that are not significantly more than the Abstract Idea, claim 6 recites a pre-solutional step necessary to perform the Abstract Idea, claims 14 and 30 recite a step of the pre-solutional activity of data gathering/adds to the Abstract Idea as this step also recites a Mental Process, claim 15 adds to the Abstract Idea as this step is a Mental Process, claims 16, 17, and 32 recite a step that adds to the Abstract idea as this step recites a Mental Process/Mathematical Process, claim 23 recites a pre-solutional step necessary to perform the Abstract Idea and an additional element that is not significantly more than the Abstract Idea, and claim 31 adds to the Abstract Idea as this step is a Mental Process and recites a step that adds to the Abstract idea as this step recites a Mental Process/Mathematical Process. 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 § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-13, 18-29, and 33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mahadevan-Jansen et al. ‘871 (US Pub No. 2009/0069871).
Regarding claim 1, Mahadevan-Jansen et al. ‘871 teaches a system of neural stimulation for intraoperative nerve monitoring for a living subject (Title, Abstract), comprising:
an optical source configured to generate light (Fig. 1 energy source 110 and [0069]);
a delivering means coupled to the optical source to deliver the generated light to a target nerve of the living subject for stimulating the target nerve (Fig. 1 probe 170 and [0071]); and
a detector coupled to the target nerve to record evoked signals responsive to the stimulation for intraoperatively monitoring of the target nerve (Fig. 1 energy detector 183 and [0071] | [0026]; “second detector”).
Regarding claim 2, Mahadevan-Jansen et al. ‘871 teaches wherein the light source comprises a laser (Fig. 1 energy source 110 and [0069]).
Regarding claim 3, Mahadevan-Jansen et al. ‘871 teaches wherein the laser comprises a pulsed infrared laser ([0029]; “pulsed infrared laser”).
Regarding claim 4, Mahadevan-Jansen et al. ‘871 teaches wherein the light is pulsed infrared light having a wavelength in a range of about 1000-2500 nm ([0067]; 2.12 µm, 2.1 µm, and 1.87 µm, is equivalent to 2120 nm, 2100 nm, and 1870 nm, respectively.), and a pulse duration in a range of about 1-10 ms ([0067]; “5-10 msec”).
Regarding claim 5, Mahadevan-Jansen et al. ‘871 teaches wherein the pulsed infrared light has a pulse energy in a range of about 1-25 mJ ([0057]; 0.2 mJ to 5 mJ) with a radiant exposure in a range of about 0.1-3 J/cm2 ([0062]; “…preferably no more than 2.0 J/cm2”).
Regarding claim 6, Mahadevan-Jansen et al. ‘871 teaches wherein the delivering means is adapted for delivering the light directly to the target nerve at a distance away from the surface of the target nerve ([0026]; “a second detector operably coupled to the target neural tissue for measuring the thermal gradient in the target neural tissue”).
Regarding claim 7, Mahadevan-Jansen et al. ‘871 teaches wherein the delivering means comprises a probe (Fig. 1 probe 170 and [0071]) having one end coupled to the optical source for receiving the light therefrom and an opposite, working end for delivering the light to the target nerve ([0071]; “…the beam of the pulsed IR light 120…is then delivered through…the probe 170 to the sciatic nerve 190 for optical stimulation thereof.”), and wherein the working end is positioned at the distance away from the surface of the target nerve such that there is no object positioned between the working end of the probe and the target nerve ([0071]; “…the probe 170 to the sciatic nerve 190…”).
Regarding claim 8, Mahadevan-Jansen et al. ’871 teaches wherein the distance is in a range of about 10-500 µm ([0085]; “…held at a constant distance of 0.5 mm…” 0.5 mm is equivalent to 500 µm).
Regarding claim 9, Mahadevan-Jansen et al. ‘871 teaches wherein the probe comprises one or more optical fibers (Fig. 1 optical fiber 160 and [0071]), one or more wave guides, one or more channels, or a combination thereof.
Regarding claim 10, Mahadevan-Jansen et al. ‘871 teaches wherein the delivering means further comprises a movable stage coupled to the probe for adjustably positioning the working end of the probe at the distance away from the target nerve ([0072]).
Regarding claim 11, Mahadevan-Jansen et al. ‘871 teaches wherein the movable stage comprises a micromanipulator ([0081]).
Regarding claim 12, Mahadevan-Jansen et al. ‘871 teaches wherein the delivering means comprises one or more optical mirrors (Fig. 1 mirror 130 and [0071]), one or more optical lenses (Fig. 1 focusing lens 140 and [0071]), one or more optical couplers (Fig. 1 coupler 150 and [0071]), or a combination thereof, placed in an optical path for focusing and/or collimating the light onto the target nerve ([0071]).
Regarding claim 13, Mahadevan-Jansen et al. ‘871 teaches wherein the detector comprises at least one sensing electrode placed in a downstream muscle associated with the target nerve for recording the evoked signals ([0049], [0056]).
Regarding claim 18, Mahadevan-Jansen et al. ‘871 teaches wherein the evoked signals comprise compound muscle action potentials (CMAPs) ([0047], [0056]).
Regarding claims 19-29 and 33, Mahadevan-Jansen et al. 871 teaches a method of neural stimulation for intraoperative nerve monitoring for a living subject, as the subject matter of claims 19-29 and 33 are analogous to the subject matter of claims 1-13 and 18.
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.
Claims 14 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Mahadevan-Jansen et al. ‘871 in view of Chen et al. ‘415 (US Pub No. 2011/0218415).
Regarding claims 14 and 30, Mahadevan-Jansen et al. ‘871 teaches all of the elements of the current invention as mentioned above except for wherein the detector is configured to record the evoked signals at a sampling rate in a range of about 5000-8000 Hz.
Chen et al. ‘415 teaches an improved design of a DSI SNA model that receives signals with frequencies between 0 and 1000 Hz with a sampling rate of 5 KHz, or 5000 Hz that aids in detecting nerve activity pre-tachycardia ([0027]).
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 detector of Mahadevan-Jansen et al. ‘871 to include recording the evoked signals at a sampling rate in a range of about 5000-8000 Hz as Chen et al. ‘415 teaches that this will aid in improving receiving signals to detect never activity pre-tachycardia.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Mahadevan-Jansen et al. ‘871 in view of Johnson et al. ‘411 (US Patent No. 4,964,411).
Regarding claim 15, Mahadevan-Jansen et al. ‘871 teaches all of the elements of the current invention as mentioned above except for wherein the detector is further configured to process the evoked signals to obtain amplitudes and latencies of the evoked signals, wherein each amplitude is a difference between the maximum and minimum of each evoked signal, and wherein each latency is a duration from the peak of the stimulus to the peak of each evoked signal.
Johnson et al. ‘411 teaches measuring short latency signal and peak amplitudes as this is useful in the study of motor endplate disease, any diseases which result with dispersion of nerve impulses such as multiple sclerosis and spinal dysfunction resulting from spinal synaptic delays. Long latency signals are useful in the study of cortical dysfunction (such as Alzheimer’s and acute insults such as strokes) (Column 6 Lines 26-38).
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 detector of Mahadevan-Jansen et al. ‘871 to include being configured to process the evoked signals to obtain amplitudes and latencies of the evoked signals, wherein each amplitude is a difference between the maximum and minimum of each evoked signal, and wherein each latency is a duration from the peak of the stimulus to the peak of each evoked signal as Johnson et al. ‘411 teaches that this will aid in studying motor endplate disease and cortical dysfunction.
Claims 16 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Mahadevan-Jansen et al. ‘871 in view of Johnson et al. ‘411 further in view of Cassar et al. ‘213 (US Pub No. 2022/0111213, provisional application 14 October 2020).
Regarding claim 16, Mahadevan-Jansen et al. ‘871 in view of Johnson et al. ‘411 teaches all of the elements of the current invention as mentioned above except for wherein the amplitudes and latencies are normalized to the mean of the corresponding baseline values.
Cassar et al. ‘213 teaches averaged normalized values for amplitude range and latency. A higher score in the adjusting steps task and a lower score in the methamphetamine-induced circling task indicate superior reduction in motor symptoms (Figs. 13B, 13D, 13E and [0026]).
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 amplitudes and latencies of Mahadevan-Jansen et al. ‘871 in view of Johnson et al. ‘411 to include being normalized to the mean of the corresponding baseline values as Cassar et al. ‘213 teaches that this will aid in determining superior reduction in motor symptoms.
Regarding claim 31, Mahadevan-Jansen et al. ‘871 teaches all of the elements of the current invention as mentioned above except for wherein said processing the evoked signals comprises
obtaining amplitudes and latencies of the evoked signals, wherein each amplitude is a difference between the maximum and minimum of each evoked signal, and wherein each latency is a duration from the peak of the stimulus to the peak of each evoked signal; and
normalizing the amplitudes and latencies to the mean of the corresponding baseline values.
Johnson et al. ‘411 teaches measuring short latency signal and peak amplitudes as this is useful in the study of motor endplate disease, any diseases which result with dispersion of nerve impulses such as multiple sclerosis and spinal dysfunction resulting from spinal synaptic delays. Long latency signals are useful in the study of cortical dysfunction (such as Alzheimer’s and acute insults such as strokes) (Column 6 Lines 26-38).
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 said processing the evoked signals of Mahadevan-Jansen et al. ‘871 to include obtaining amplitudes and latencies of the evoked signals, wherein each amplitude is a difference between the maximum and minimum of each evoked signal, and wherein each latency is a duration from the peak of the stimulus to the peak of each evoked signal as Johnson et al. ‘411 teaches that this will aid in studying motor endplate disease and cortical dysfunction.
Cassar et al. ‘213 teaches averaged normalized values for amplitude range and latency. A higher score in the adjusting steps task and a lower score in the methamphetamine-induced circling task indicate superior reduction in motor symptoms (Figs. 13B, 13D, 13E and [0026]).
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 said processing the evoked signals of Mahadevan-Jansen et al. ‘871 in view of Johnson et al. ‘411 to include normalizing the amplitudes and latencies to the mean of the corresponding baseline values as Cassar et al. ‘213 teaches that this will aid in determining superior reduction in motor symptoms.
Claims 17 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Mahadevan-Jansen et al. ‘871 in view of Johnson et al. ‘411 further in view of Cassar et al. ‘213 further in view of Mahon et al. ‘679 (US Pub No. 2016/0270679).
Regarding claims 17 and 32, Mahadevan-Jansen et al. ‘871 in view of Johnson et al. ‘411 further in view of Cassar et al. ‘213 teaches all of the elements of the current invention as mentioned above except for wherein a ≥ 50% loss in a baseline amplitude and a ≥ 10% increase in a baseline latency serve as thresholds for neural damage detection.
Mahon et al. ‘679 teaches acute changes in SEPs, such as, for example, decreases in amplitude or size (i.e., area) or increases in latency of the SEP waveform, can be indicative of a pending nerve injury. As one non-limiting example, a 30-50% decline in amplitude or a 3 millisecond or 10% increase in latency, relative to a baseline, may indicate an impending nerve injury ([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 system/method of Mahadevan-Jansen et al. ‘871 in view of Johnson et al. ‘411 further in view of Cassar et al. ‘213 to include wherein a ≥ 50% loss in a baseline amplitude and a ≥ 10% increase in a baseline latency serve as thresholds for neural damage detection as Mahon et al. ‘679 teaches that this will aid in indicating a pending/impending nerve injury.
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