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, 5, 7-12, 15, 18, 19, 22-28, 31, and 33 are currently pending. Claims 2-4, 6, 13, 14, 16, 17, 20, 21, 29, 30, and 32 have been cancelled. Claims 1, 5, 7, 12, 15, 19, 22, 23, 28, and 31 have been amended. Claims 15 and 31 have been amended to overcome the objections set forth in the Non-Final Office Action mailed on 29 December 2025. Claim 16 has been cancelled and has rendered the objection moot. Claims 2 and 6 have been cancelled and have rendered the 35 U.S.C. 112(b) rejections moot.
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, 7, 10, 12, 19, 23, and 28.
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 § 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, 7-12, 15, 18, 19, 22-28, 31, and 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 steps of: a processor configured to:
calculate an amplitude and a latency for each recorded evoked signal;
normalize the amplitude and latency to corresponding baseline values; and
determine neural damage when the normalized values exceed a threshold of a ≥ 50% loss in a baseline amplitude or a ≥ 10% increase in a baseline latency, thereby intraoperatively monitoring the target nerve
set forth a judicial exception. These steps describe mathematical relationships, mathematical formulas or equations, mathematical calculations. Thus, the claim is drawn to a Mathematical Concept, which is an Abstract Idea. The determining step also describes a concept performed in the human mind (including an observation, evaluation, judgment, opinion). Thus, the claim is also 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 determining neural damage when the normalized values exceed a threshold of a ≥ 50% loss in a baseline amplitude or a ≥ 10% increase in a baseline latency, thereby intraoperatively monitoring the target nerve, which is merely adding insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)). The determining of neural damage 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 neural damage, 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 comprising a pulsed infrared laser configured to generate pulsed infrared light having a wavelength in a range of 1000-2500 nm and a pulse duration in a range of from 100 µs to 10 ms; a delivering means coupled to the optical source and configured to deliver the pulsed infrared light directly to a target nerve of the living subject for stimulating the target nerve; and a detector comprising at least one sensing electrode placed on the target nerve and configured to record evoked signals responsive to the stimulation at a sampling rate of 5000-8000 Hz. Generating light, delivering the generated light, and recording evoked signals are well-understood, routine and conventional activity for those in the field of medical diagnostics. Further, the generating, delivering, and recording 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)).
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.
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.
The dependent claims also fail to add something more to the abstract independent claims. Claims 5, 7-12, 18, 22, 24-28, and 33 recite additional elements that are not significantly more than the Abstract Idea, claim 15 adds to the Abstract Idea as this step is a Mental 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 § 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, 5, 7-12, 18, 19, 22-28, 31, and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Mahadevan-Jansen et al. ‘871 (US Pub No. 2009/0069871 – previously cited) in view of Chen et al. ‘415 (US Pub No. 2011/0218415 – previously cited) further in view of Cassar et al. ‘213 (US Pub No. 2022/0111213 – previously cited) further in view of Mahon et al. ‘679 (US Pub No. 2016/0270679 – previously cited).
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 comprising a pulsed infrared laser (Fig. 1 energy source 110 and [0069], [0029]; “pulsed infrared laser”) configured to generate pulsed infrared light (Fig. 1 energy source 110 and [0069]) having a wavelength in a range of 100-2500 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 from 100 µs to 10 ms ([0067]; “5-10 msec”);
a delivering means coupled to the optical source and configured to to deliver the pulsed infrared light directly to a target nerve of the living subject for stimulating the target nerve (Fig. 1 probe 170 and [0071]); and
a detector comprising at least one sensing electrode placed on the target nerve ([0026]; “a second detector operably coupled to the target neural tissue for measuring the thermal gradient in the target neural tissue” [0056]; “electrodes placed in the nerve”) and configured to record evoked signals responsive to the stimulation (Fig. 1 energy detector 183 and [0071] | [0026]; “second detector”);
and a processor (Fig. 1 computer 184 and [0073]).
Mahadevan-Jansen et al. ‘871 teaches all of the elements of the current invention as mentioned above except for wherein the stimulation is at a sampling rate of 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 stimulation of Mahadevan-Jansen et al. ‘871 to include being at a sampling rate of 5000-8000 Hz as Chen et al. ‘415 teaches that this will aid in improving receiving signals to detect never activity pre-tachycardia. 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.
Mahadevan-Jansen et al. ‘871 in view of Chen et al. ‘415 teaches all of the elements of the current invention as mentioned above except for the processor configured to: calculate an amplitude and a latency for each recorded evoked signal; and normalize the amplitude and latency to corresponding baseline values; and
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 processor of Mahadevan-Jansen et al. ‘871 in view of Chen et al. ‘415 to include calculating an amplitude and a latency for each recorded evoked signal; and normalizing the amplitude and latency to corresponding baseline values; and as Cassar et al. ‘213 teaches that this will aid in determining superior reduction in motor symptoms.
Mahadevan-Jansen et al. ‘871 in view of Chen et al. ‘415 further in view of Cassar et al. ‘213 teaches all of the elements of the current invention as mentioned above except for the processor configured to determine neural damage when the normalized values exceed a threshold of a ≥ 50% loss in a baseline amplitude or a ≥ 10% increase in a baseline latency, thereby intraoperatively monitoring the target nerve.
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 processor of Mahadevan-Jansen et al. ‘871 in view of Chen et al. ‘415 further in view of Cassar et al. ‘213 to include determining neural damage when the normalized values exceed a threshold of a ≥ 50% loss in a baseline amplitude or a ≥ 10% increase in a baseline latency, thereby intraoperatively monitoring the target nerve as Mahon et al. ‘679 teaches that this will aid in indicating a pending/impending nerve injury.
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 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 pulsed infrared light therefrom and an opposite, working end configured to deliver the pulsed infrared light to the target nerve in a non-contact manner ([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 a distance away from a surface of the target nerve.
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 pulsed infrared light onto the target nerve ([0071]).
Regarding claim 18, Mahadevan-Jansen et al. ‘871 teaches wherein the evoked signals comprise compound muscle action potentials (CMAPs) ([0047], [0056]).
Regarding claims 19, 22-28, 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.
Regarding claim 31, Mahadevan-Jansen et al. ‘871 in view of Chen et al. ‘415 further in view of Cassar et al. ‘213 further in view of Mahon et al. ‘679 teaches all of the elements of the current invention as mentioned above except for wherein each amplitude is a difference between a maximum and a minimum of each evoked signal, and wherein each latency is a duration from a peak of a stimulus to a 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 method of Mahadevan-Jansen et al. ‘871 in view of Chen et al. ‘415 further in view of Cassar et al. ‘213 further in view of Mahon et al. ‘679 to include wherein each amplitude is a difference between a maximum and a minimum of each evoked signal, and wherein each latency is a duration from a peak of a stimulus to a 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.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Mahadevan-Jansen et al. ‘871 in view of Chen et al. ‘415 further in view of Cassar et al. ‘213 further in view of Mahon et al. ‘679 further in view of Johnson et al. ‘411 (US Patent No. 4,964,411 – previously cited).
Regarding claim 15, Mahadevan-Jansen et al. ‘871 teaches all of the elements of the current invention as mentioned above except for wherein each amplitude is a difference between a maximum and a minimum of each evoked signal, and wherein each latency is a duration from a peak of a stimulus to a 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 system of Mahadevan-Jansen et al. ‘871 in view of Chen et al. ‘415 further in view of Cassar et al. ‘213 further in view of Mahon et al. ‘679 to include 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.
Response to Arguments
Applicant argues that the amended claims are directed to a specific apparatus for intraoperative nerve monitoring. However, the claimed structures are found to be well-understood, routine, and conventional (WURC) as supported by Mahadevan-Jansen et al. ‘871 (see 35 U.S.C. 103 rejection).
Applicant argues that the claim as a whole integrates the recited elements into a practical application. However, the claimed optical source, delivering means, and detector are WURC components used to perform the pre-solutional activity of data gathering. Although the claims were amended to recite particular wavelength ranges, pulse duration, and sampling rates, these are seen as WURC, as supported by Mahadevan-Jansen et al. ‘871 (see 35 U.S.C. 103 rejection).
Applicant argues that the additional elements are not WURC. Examiner respectfully disagrees. As previously mentioned, these elements are WURC as supported by Mahadevan-Jansen et al. ‘871.As such, the 35 U.S.C. 101 rejection has been maintained.
Applicant argues that Mahon et al. ‘679 does not teach “neural damage when the normalized values exceed a threshold of ≥ 50% loss in baseline amplitude or a ≥ 10% increase in baseline latency. However, it is noted that claims recite “≥” which indicates “greater than or equal to.” The 30-50% taught by Mahon et al. ‘679 falls within the range of “≥ 50% loss” as the 50% of Mahon et al. ‘679 falls into the range of “≥ 50% loss.” This is the same for 10% increase of Mahon et al. ‘679 as the 10% falls within the “≥ 10% increase” range as claimed as the 10% of Mahon et al. ‘679 falls within the claimed range of “≥ 10% increase” as “≥” indicates “greater than or equal to.” As such, Applicants arguments are not persuasive.
Conclusion
THIS ACTION IS MADE FINAL. 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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