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 .
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.
No claims are interpreted under 112(f).
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.
Claim 3 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more.
The claim recites “determining a location of a nerve based on comparing amplitudes of the first and second potentials.”
Under the first of the two-prong inquiry of step 2A for evaluating 101, this limitation is considered a mental process because the “determining” functions when given their broadest reasonable interpretation may be performed in the user’s mind, i.e. a user can mentally observe a location of a nerve by visually comparing amplitudes of first and second potentials on a screen or device.
Under the second of the two-prong inquiry of step 2A, this judicial exception is not integrated into a practical application because there are no limitations that indicate improvements to the functioning of a computer or to the technology/technical field; effecting a particular treatment or prophylaxis for a disease/condition; applying the judicial exception with a particular machine (the control unit and sensor are recited with such generality that they are not considered a particular machine); effecting a transformation or reduction of a particular article to a different state/thing; applying the judicial exception in a meaningful way beyond generally linking to a particular technological environment. There are no limitations referring to any practical output or application in the claims.
Since the second of the two-prong inquiry of step 2A is not satisfied, the claim is then evaluated under step 2B.
Under step 2B for evaluating 101, the claim(s) does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the other limitations present do not impose meaningful limits on the abstract idea. The recited inserting a dilator into patient muscle, the dilator including a distal end portion including first and second electrodes, communicating current to a sub-dermal electrode implanted in the patient to produce a nerve action potential (NAP), and sensing the NAP by detecting a first potential on the first electrode and a second potential on the second electrode merely constitute generically claimed well-understood, routine, and conventional structures that operate as such to perform common data gathering in the nerve monitoring art. Therefore, they do not add significantly more to the abstract idea.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-2 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for titrating the current used to find the lowest current that will stimulate one of multiple electrodes to identify which electrode is closest to the nerve, does not reasonably provide enablement for using just any “first series of unequal current amplitude applications to the first electrode” and just any "second series of unequal current amplitude applications to the second electrode" to determine the "relative location of a nerve based on the sensing of at least one of the first and second evoked potentials."
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
A) Specifically, when the current is titrated to find the lowest current amplitude that will produce an evoked response for a particular electrode, the stimulus supplied is based on finding the lowest current amplitude. For example, in [0038], the current is increased or decreased based on whether or not there was a response for the previous current level. However, as claimed, “a first series of unequal current amplitude applications to the first electrode to produce at least a first evoked potential" could be as simple as two unequal current amplitude applications that both produce evoked potentials, and “a second series of unequal current amplitude applications to the second electrode to produce at least a second evoked potential” could be two unequal current amplitude applications that both produce evoked potentials. If both series provide the same stimulations (e.g. 5 mA and 6 mA), and both electrodes produce an evoked potential for each of these stimulation levels, Applicant's specification has not enabled one having ordinary skill in the art at the time the invention was made to determine “a relative location of a nerve” based on this data.
Further, as claimed, the series do not have to be equal or methodical in any manner; for example, if “a first series of unequal current amplitude applications to the first electrode to produce at least a first evoked potential" is 5 mA and 6 mA and both produce evoked potentials, and “a second series of unequal current amplitude applications to the second electrode to produce at least a second evoked potential” is 3 mA and 4 mA and both produce evoked potentials, the series are communicated and the evoked potentials are sensed as required by Applicant’s claim language, but Applicant's invention has not enabled one having ordinary skill in the art at the time the invention was made to determine “a relative location of a nerve” based on this data. The specification is only enabled
B) Additionally, if the current were titrated in a manner enabled by Applicant's specification, Applicant's specification has enabled, for when an evoked response is produced for each electrode as claimed by Applicant, for the relative location of the nerve to be determined based on the electrode that had the lowest current amplitude level. See, for example, the last sentence of [0038].
However, the claim is drawn to "determining a relative location of a nerve based on the sensing of at least one of the first and second electrodes", and this would include claiming the determination of a relative location of a nerve based on the sensing of a single electrode when both electrodes have produced evoked potentials. However, as Applicant's specification requires the lowest current amplitude level of each electrode when an evoked response is produced for each electrode, Applicant has not enabled one of ordinary skill in the art to make or use the invention commensurate in scope with these claims.
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 2 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.
It is unclear if the non-transitory medium storing instructions is meant to include instructions to enable communication of the first and second series of unequal current amplitude applications, given the way it is presented. While it is assumed that said steps are included in the non-transitory medium storing instructions, clarification is required.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Farquhar et al (US Pub No. 20070016097 – cited by applicant).
In regard to Claim 1, Farquhar et al disclose a method for monitoring nerve tissue during a lateral interbody fusion (LIF) comprising:
inserting a dilator 34 into patient psoas muscle to perform a LIF (0013), best seen in Figure 2 – “sequential dilation access system 34 comprises, by way of example only, a K-wire 46, one or more dilating cannula 48, and a working cannula 50” (0059),
the dilator 46 including a distal end portion including first and second electrodes – “Each K-wire 46, dilating cannula 48 and/or working cannula 50 may be equipped with multiple (e.g., four orthogonally-disposed) stimulation electrodes to detect the location of nerves in between the skin of the patient and the surgical target site” (0062-0063);
while the dilator is in psoas muscle, communicating (a) a first series of unequal current amplitude applications to the first electrode to produce at least a first evoked potential by using the arc method which doubles the current – “each electrode 1402 is stimulated at the same stimulation current level before passing to the next stimulation current level. In this fashion, successive directional information can be obtained as described above… The value of I.sub.Stim may be adjusted by a bracketing method as follows. The first bracket may be 0.2 mA and 0.3 mA. If the Vpp corresponding to both of these stimulation currents is lower than V.sub.thresh, then the bracket size may be doubled to 0.2 mA and 0.4 mA. This doubling of the bracket size continues until the upper end of the bracket results in a Vpp that is above V.sub.Thresh” (0077), and
(b) a second series of unequal current amplitude applications to the second electrode to produce at least a second evoked potential – performing the same arc method for the second electrode (0070-0082);
sensing the first and second evoked potentials (0070-0082); and
determining a relative location of a nerve based on the sensing of at least one of the first and second evoked potentials, best seen in Figure 10 – “the "arc" bracketing process proceeds for each of the stimulation electrodes 1402A-1402D to provide, in succession, more accurate information regarding the direction of the nerve relative to the surgical access instrument 46-50”; As shown in FIG. 10, an arc (wedge) containing the final direction vector is computed from the range information for the stimulation current thresholds corresponding to the four stimulation electrodes 1402A-1402D. This can be done as often as desired as the bracketing method proceeds. The arc (wedge) may then be used to display directional information to the operator, as in FIGS. 15A-15C” (0072-0073).
2. Farquhar et al disclose an article comprising a non-transitory medium storing instructions that enable a processor-based system to:
while a dilator 34, best seen in Figure 2 – “sequential dilation access system 34 comprises, by way of example only, a K-wire 46, one or more dilating cannula 48, and a working cannula 50” (0059),
which includes including a distal end portion having first and second electrodes is located in muscle, best seen in Figure 2 – “Each K-wire 46, dilating cannula 48 and/or working cannula 50 may be equipped with multiple (e.g., four orthogonally-disposed) stimulation electrodes to detect the location of nerves in between the skin of the patient and the surgical target site” (0062-0063), communicate
(a) a first series of unequal current amplitude applications to the first electrode to produce at least a first evoked potential using the arc method which doubles the current – “each electrode 1402 is stimulated at the same stimulation current level before passing to the next stimulation current level. In this fashion, successive directional information can be obtained as described above… The value of I.sub.Stim may be adjusted by a bracketing method as follows. The first bracket may be 0.2 mA and 0.3 mA. If the Vpp corresponding to both of these stimulation currents is lower than V.sub.thresh, then the bracket size may be doubled to 0.2 mA and 0.4 mA. This doubling of the bracket size continues until the upper end of the bracket results in a Vpp that is above V.sub.Thresh” (0077), and
(b) a second series of unequal current amplitude applications to the second electrode to produce at least a second evoked potential – performing the same arc method for the second electrode (0070-0082);
sense the first and second evoked potentials (0070-0082); and
determine a relative location of a nerve based on the sensing of at least one of the first and second evoked potentials, best seen in Figure 10 – “the "arc" bracketing process proceeds for each of the stimulation electrodes 1402A-1402D to provide, in succession, more accurate information regarding the direction of the nerve relative to the surgical access instrument 46-50”; As shown in FIG. 10, an arc (wedge) containing the final direction vector is computed from the range information for the stimulation current thresholds corresponding to the four stimulation electrodes 1402A-1402D. This can be done as often as desired as the bracketing method proceeds. The arc (wedge) may then be used to display directional information to the operator, as in FIGS. 15A-15C” (0072-0073).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Farquhar et al in view of Ferree (US Pub No. 20040225228).
Farquhar et al disclose a method including:
inserting a dilator 34, best seen in Figure 2 – “sequential dilation access system 34 comprises, by way of example only, a K-wire 46, one or more dilating cannula 48, and a working cannula 50” (0059), into muscle (0007),
the dilator including a distal end portion including first and second electrodes – “Each K-wire 46, dilating cannula 48 and/or working cannula 50 may be equipped with multiple (e.g., four orthogonally-disposed) stimulation electrodes to detect the location of nerves in between the skin of the patient and the surgical target site” (0062-0063);
communicating current to a sub-dermal electrode 2300 implanted in the patient to produce a nerve action potential (NAP) – “Using the four co-planar electrodes (FIGS. 8 and 13), it is not particularly easy to identify direction to the nerve along the z-axis. This may be easily rectified by the addition of one or more stimulation electrodes 2300 (FIG. 23)” (0102, 0013);
sensing the NAP by detecting a first potential on the first electrode and a second potential on the second electrode (0070-0082); and
determining a location of a nerve based on comparing the first and second potentials to a threshold (0070-0082).
However, Farquhar et al do not expressly disclose comparing amplitudes of the first and second potentials.
Ferree teach that it is well-known in the art to compare amplitudes obtained from stimulating nerves to determine the distance from an instrument R2 to a nerve S1 (0132).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Farquhar et al such that the comparing comprises compare amplitudes of the first and second potentials as taught by Ferree as an equally as effective manner of comparing the signals to determine the distance and direction to the nerve.
Conclusion
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/H.Q.N/Examiner, Art Unit 3791
/JENNIFER ROBERTSON/ Supervisory Patent Examiner, Art Unit 3791