DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
Applicant's submission filed on 12/17/2025 has been entered. Claims 21-23, 25-33, and 35-40 remain pending, claims 21-23, 27, 31-33, 37 and 38 have been amended, claims 25-26, 28-30, 35-36, and 39-40 having been canceled.
Response to Argument
Rejections under 35 USC 112
The Applicant argument filed on 12/17/2025 are fully considered, but they are not persuasive.
Applicant remarks in the last paragraph of page 12 of the response that applicant has amended the claims to address the outstanding 112(a) and 112(b) rejections.
The claim amendments filed 12/17/2025 only partially address the previous rejections of 112(a) with respect to the previously recited limitations of “the nerve equidistant from a first position on the patient when a second stimulation electrode stimulates the nerve”, “the nerve equidistant from a second position on the patient when a second stimulation electrode stimulates the nerve”. This portion of the previous rejection of the claims rejected under 112(a) have been rendered moot and has been withdrawn.
However, applicant has not addressed the other remaining issues outlined in the previous rejections under 112(a) and 112(b), and the newly filed amendments add further clarity issues to the claim. Accordingly, the rejections have been updated below.
Nonetheless, with specific regard to one aspect of the outstanding 112(b) rejections, and as previously remarked in the previous and presently updated 112(b) rejections of the claims, applicant is using the term “equidistant” in a way that is inconsistent with the accepted meaning of the word.
Applicant is reminded that where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). The term “equidistant” in claim 21 is used by the claim to mean “a plurality of points having an equal distance extending away from a singular center point for a given position where the singular center point is the location of a stimulation electrode along the longitudinal axis of a surgical device at a given position,” while the accepted meaning is “equally far from two or more places”. The term is indefinite because the specification does not clearly redefine the term. Please see the rejection below which provided further discussion on this matter and the other outstanding, and newly presented, issues in the claims.
Applicant has not amended nor addressed in their remarks the reasons outlined in the previous 112(b) rejection of claim 33.
Therefore, the claims remain rejected and the rejection is made final.
Rejections under 35 USC 103
The Applicant argument filed on 12/17/2025 are fully considered, but they are not persuasive.
Applicant’s arguments with respect to claim(s) have been considered but are moot because the new grounds of rejection has been presented. Consequently, the arguments do not apply to new references or the new combination of the references being used in the current rejection.
Nonetheless, the following arguments are addressed below:
Applicant argues in the first-second paragraphs of page 7
“Applicant has amended the claims to emphasize and clarify that both the first and second spherical loci are generated using one stimulation electrode that is repositioned, and that the apparatus/method obtains or determines the nerve's location from the intersection. Hence, as amended, independent claims recite that both the first and second spherical loci are determined ‘from a first position of a first stimulation electrode’ and ‘from a second position of the first stimulation electrode’, wherein the first stimulation electrode has been repositioned.
‘FIG. 2 depicts one embodiment of a system 200 for mapping the location of a nerve 104 using a single stimulation electrode 102 which is positioned at a first position 103 and then repositioned to a second position 201... Thus, in certain embodiments, where a single stimulation electrode 102 is used to determine two distances, the position of the nerve 104 may typically be pinpointed with an accuracy of circle 214.’ Applicant's US Patent Publication No. US20200315532A1, paragraphs 53-56”.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “that both the first and second spherical loci are generated using one stimulation electrode that is repositioned”, “a system 200 for mapping the location of a nerve 104 using a single stimulation electrode 102 which is positioned at a first position 103 and then repositioned to a second position 201”, “where a single stimulation electrode 102 is used to determine two distances”, and “the position of the nerve 104 may typically be pinpointed with an accuracy of circle 214” (emphasis added)) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In response to applicant's argument that applicant has amended the claim to recite “that both the first and second spherical loci are generated using one stimulation electrode”, “a system 200 for mapping the location of a nerve 104 using a single stimulation electrode 102 which is positioned at a first position 103 and then repositioned to a second position 201”, “where a single stimulation electrode 102 is used to determine two distances”, and “the position of the nerve 104 may typically be pinpointed with an accuracy of circle 214” (emphasis added), it is noted that applicant has not amended the claim to recite active limitations that indicate that the functions of generat[ion], mapping, reposition[ing, determin[ing], and pinpoint[ing]…with accuracy.
Applicant is reminded, with respect to apparatus and system claims, that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Applicant argues in the third paragraph of page 7
“Kaula shows multiple different stimulation electrodes fixed around a field and analyzes proximity, not the same stimulation electrode being repositioned to produce successive spherical loci used for trilateration/triangulation of a nerve. Kaula's figures and text describe plural electrodes around a surgical corridor driving EMG responses to infer proximity/direction, not a workflow in which a single stimulation electrode is moved to create multiple ranged spheres around the same emitter and solve the nerve position from their intersection. See US Patent Publication No. 20090209879, paragraph 65. Kaula does not teach or suggest using the same stimulation electrode, moved to different positions, to generate multiple spherical loci and then computing their intersection; Kaula instead teaches using multiple distinct stimulation electrodes (or a distributed electrode set) to gauge nerve proximity/direction via threshold responses (see, e.g., proximity/direction/pathology determinations with plural electrodes), with no disclosure that a single stimulator is repositioned to form separate spherical loci for nerve solving”.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “the same stimulation electrode being repositioned to produce successive spherical loci”, “successive spherical loci used for trilateration/triangulation of a nerve”, “a workflow in which a single stimulation electrode is moved”, “create multiple ranged spheres around the same emitter”, “solve the nerve position from their [multiple ranged spheres around the same emitter] intersection”, “using the same stimulation electrode, moved to different positions”, “generate multiple spherical loci”, and “then computing their [multiple spherical loci] intersection” (emphasis added)) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Applicant argues in the second-third paragraphs of page 8
“Examiner relies on Byrd for "intersection of spheres" math, but Byrd uses ranging to localize a known probe or sensor position by intersecting spheres centered on known field sources. Byrd's ranging teaches solving the probe's position from multiple ranges to sources, not solving a nerve's position from ranges measured by a stimulator-to-nerve relationship and then outputting a nerve location to be mapped. See US Patent Publication No. 20100106011, paragraph 21.
Even where Byrd states a position can be calculated as ‘the intersection of three or more spheres of radius Ri,’ the solved object is the probe/sensor; transposing that to nerves is not taught, and Byrd's motivation is to localize catheters without stimulating nerves. Hence, Byrd's intersection-of-spheres disclosure is expressly used to compute a probe/catheter position from ranges to field sources, not to compute a nerve location from stimulator-to-nerve distances. Byrd thus fails to teach the now-claimed determination/obtaining of a nerve location from the intersection of loci generated by a repositioned stimulator”.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “solving a nerve's position from ranges measured by a stimulator-to-nerve relationship, “then outputting a nerve location to be mapped”, “transposing [the intersection of three or more spheres of radius]”, “compute a nerve location from stimulator-to-nerve distances”, “using the same stimulation electrode, moved to different positions”, “obtaining of a nerve location from the intersection of loci”, and “loci [plural, i.e., both the first locus and the second locus] generated by a repositioned stimulator” (emphasis added)) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Applicant argues in the second final paragraph of page 8
“Hence, while Kaula discloses systems for determining nerve proximity/direction relative to surgical instruments using plural electrodes and EMG, including pathology assessment thresholds; Kaula lacks a single stimulation electrode that is physically repositioned to form multiple spherical loci, and computation and output of a nerve location from locus intersections. While Byrd discloses computing the 3D position of a probe/sensor as an intersection of multiple spheres derived from ranges to known emitters and also includes ultrasound imaging modules; Byrd lacks using a single, repositioned stimulator to form nerve loci and obtaining the nerve's location from intersections. Its sphere-intersection result is for probe localization, not nerve localization”.
As a preliminary matter, applicant is reminded that “the prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed….” In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004). (See MPEP 2145(X)(D)(1)).
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “a single stimulation electrode that is physically repositioned to form multiple spherical loci”, “computation and output of a nerve location from locus intersections”, “using a single, repositioned stimulator to form nerve loci”, “obtaining the nerve's location from intersections”, and “sphere-intersection result is for…nerve localization” (emphasis added)) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Therefore, the claims remain rejected and the rejection has been made final.
Claim Interpretation - 35 USC § 112(f)
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-AlA 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 comm only referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AlA 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 place holder 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 place holder 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-AlA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under35 U.S.C. 112(f) or pre-AlA 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-AlA 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-AlA 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 under35 U.S.C. 112(f) or pre-AlA 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 place holder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“electrode positioning module” in claims 23 and 33;
This claims limitations are being interpreted as:
“electrode positioning module”, as described in FIGS. 4 and 7, and pars. [0010]-[0013], [0067], [0070], [0084]-[0088], and [0095]-[0101] of the publication, because these claims limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AlA 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.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AlA 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-AlA 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 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 21-23, 27, 31-33, and 37-38 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 21 has been amended to recite “a control module comprising circuitry”, “an imaging module comprising circuitry” and “an overlay module comprising circuitry” in lines 3-9, 14, and 16 are described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. A review of applicant’s originally filed disclosure found that the apparatus may include a control module (see [0067], FIG. 4 of the PG Pub); in one embodiment the control module includes a stimulation module, a stimulation detection module, a distance module, and a mapping module (see [0067], FIG. 4); in another embodiment, the control module may also include an electrode positioning module, a position detection module, an imaging module, an overlay module, and a marking module (see [0067], FIG. 4).
In certain embodiments, the imaging module includes one or more of an imaging device which selected from an x-ray device, a computerized axial tomography device, a magnetic resonance imaging device, and an ultrasound device (see [0016]).
Additionally, applicant discloses “that numerous specific details are provided, such as examples of programming, software modules, user selections, network transactions, database queries, database structures, hardware modules, hardware circuits, hardware chips, etc., to provide a thorough understanding of embodiments of the subject matter which may be practiced without one or more of the specific details, or with other methods, components, materials, and so forth” (see [0037], emphasis added).
However, this does not provide support for what is claimed, e.g., that the control model, an imaging module or an overlay module are each comprising circuitry and that the nerve as being equidistant from a first position on the patient and a second position on the patient, and no basis has been pointed to for these limitations in applicant' s remarks. In the absence of support for the newly recited limitations, these claims and claims dependent thereon are deemed to constitute new matter. This is a NEW MATTER rejection.
Claim 31 is also rejected for reciting the same and/or limitations outlined above.
All dependent claims are also rejected by the nature of their dependency.
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 21-23, 27, 31-33, and 37-38 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.
Claim 21 has been amended to recite “a control module comprising circuitry”, “…the nerve equidistant from a first position of a first stimulation electrode when the first stimulation electrode stimulates the nerve”, “…the nerve equidistant from a second position of the stimulation electrode when the first stimulation electrode stimulates the nerve”, “…the nerve equidistant from a second position on the patient when a second stimulation electrode stimulates the nerve”, “an imaging module comprising circuitry” and “an overlay module comprising circuitry” in lines 3-9, 14, and 16, which renders the claim indefinite because it is unclear if the imaging module and the overlay module are separate and distinct structures from the control module, as present recited in the claim, as applicant’s specification discloses that the imaging module and the overlay module are rather sub-components of the control module (see [0067], FIG. 4).
Further, as applicant’s disclosure provides that the imaging module is a sub-component included in/of the control module as discussed above, and that the imaging module includes an x-ray device, a computerized axial tomography device, a magnetic resonance imaging device, and an ultrasound device (see [0016]); it is further unclear how an x-ray device, a computerized axial tomography device, a magnetic resonance imaging device, and an ultrasound device can functionally and structurally be sub-components of the control module, for which the structure of is unclear.
Additionally, it is noted that while applicant discloses in [0037] that “…numerous specific details are provided, such as examples of programming, software modules, user selections, network transactions, database queries, database structures, hardware modules, hardware circuits, hardware chips, etc., to provide a thorough understanding of embodiments of the subject matter which may be practiced without one or more of the specific details, or with other methods, components, materials, and so forth” (emphasis added), the specification does not appear to provide clear disclosure that the modules as claimed are physical hardware modules and applicant has not provided a statement regarding that the modules as claim are explicitly not software modules.
Further, it is unclear if “the nerve equidistant” from a first position on the patient when a first stimulation electrode stimulates the nerve for which thereof a first spherical locus of potential sites is determined is meant to refer to the earlier recited nerve in the patient for which a location thereof is visually displayed as recited in the preamble, or if applicant meant to refer to a different nerve. Similarly, it is unclear if “the nerve equidistant” from a second position on the patient when a second stimulation electrode stimulates the nerve, for which thereof a second spherical locus of potential sites is determined is meant to refer to the earlier recited nerve in the patient for which a location thereof is visually displayed as recited in the preamble; or if applicant meant to refer to the nerve equidistant from a first position on the patient when a first stimulation electrode stimulates the nerve.
It is also unclear how the nerve is “equidistant” from a singular position, e.g., from a first position of a first stimulation electrode when the first stimulation electrode stimulates the nerve and from a second position of the first stimulation electrode the first stimulation electrode stimulates the nerve, as Oxford Learner’s Dictionary defines the term “equidistant” to mean “equally far from two or more places” (emphasis added). Applicant only recites the first spherical locus and the second spherical locus as being equidistant from a respective singular position of the first stimulation election (i.e., each corresponding to a respective singular first or second location).
It is unclear if the stimulation only occurs once or if the nerve is stimulated twice, e.g. stimulated a first time in a first position and stimulated a second time in a second position.
Claims 22-23, 27, 31-33, and 37-38 are also rejected for reciting the same and/or limitations outlined above.
All dependent claims are also rejected by the nature of their dependency.
Claim 33 has been amended to recite “...wherein the apparatus further comprises an electrode positioning module comprising circuitry, the method further comprising...” in line 1 is indefinite because it is unclear because claim 31 is directed to a method claim. Therefore, it unclear if claim 33 is directed to an apparatus or method.
All dependent claims are also rejected by the nature of their dependency.
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 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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained through the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claims 21-22, 27, 31-32, and 37-38 are rejected under 35 U.S.C. 103 as being unpatentable over Kaula et al. (US20090209879, hereafter” Kaula”), in view of Byrd et al. (US20100106011, hereafter “Byrd”), and further in view of Cory et al. (US20110082383, hereafter “Cory”).
Regarding claims 21 and 31, Kaula discloses a method and an apparatus configured to visually display a location of a nerve in a patient (FIGS. 1, 2, 7, [0024], [0035]-[0037], the surgical system 10 includes a touch screen display 36, and during a medical operation the surgical system 10 receives and display the nerve location as illustrated in FIG. 7), the apparatus comprising:
a control module comprising circuitry (FIGS. 1, 2, [0011], [0037], The control unit 12 (see FIG. 2)) configured to:
determine a first locus of potential sites of the nerve equidistant from a first position of a first stimulation electrode* when the first stimulation electrode stimulates the nerve (FIG. 13, [0064]-[0070], determine the distance from the first electrode of the plurality of electrodes to a nerve region, wherein each distance measurement represents a distance from the circle that represent denote the position of the electrode respective to the origin or center of the cannula, d denotes the distance to the nerve location that represent by octagon. The first locus of potential sites of the nerve equidistant from a first position corresponds to one of the represents location measured from the center of the cannula with the first electrode to the location where the nerve exists, a vector is drawn from the origin along the axis corresponding to the first electrode that has a length equal to IThresh for first electrode in order to compute the vector from the origin to a direction pointing toward the nerve, thus the cited disclose of Kaula reading on the limitation a first locus of potential sites of the nerve equidistant from a first position of a first stimulation electrode);
determine a second locus of potential sites of the nerve equidistant from a second position of the first stimulation electrode* when the first stimulation electrode* stimulates the nerve ([0064]-[0070], FIGS. 7, 13, real-time monitoring of the distance of the 4 electrodes (inclusive of the first electrode) from the nerve further, specifically, including real-time monitoring of the distance of the first electrode from a nerve, as the probe is advanced/ repositioned though various positions (including second position, wherein each distance measurement represents a distance from the circle that represent denote the position of the electrode respective to the origin or center of the cannula, d denotes the distance to the nerve location that represent by octagon. The second locus of potential sites of the nerve equidistant from a second position corresponds to one of the distances from first electrode to the octagon which denotes the nerve location. As the operator selects any one of the 4 channels available to perform the direction function, thus reading on the limitation of the first electrode being used to determine the first position and the second position, respectively. A vector is drawn from the origin along the axis corresponding to the first electrode that has a length equal to IThresh for first electrode in order to compute the vector from the origin to a direction pointing toward the nerve, thus the cited disclose of Kaula reading on the limitation a second locus of potential sites of the nerve equidistant from a first position of a first stimulation electrode), wherein the first stimulation electrode has been repositioned such that the second position is different from the first position ([0064]-[0070] the operator returns to the Detection Function to continue advancing/ reposition the instrument to the second position where the Direction Function can be determined, therefore, as the instrument is advanced and repositioned to the second position, it is reads on the limitation that the second position is different from the first position as the Direction function is performed at a physically separate location from the first position).
It is noted that as discussed above Kaula discloses “the location of the nerve” and the location (i.e., locus) being in x-y plane between the nerve and a plurality of electrodes, and identification of the location of the nerve and Kaula further discloses imaging of the patient (see [0070] additional radiographic imaging may be deemed appropriate to establish the best course of action) and an image of the patient's anatomy (see table 1, an image of the spine), however, Kaula does not explicitly disclose a first spherical locus, a second spherical locus, determine an intersection of the first spherical locus of potential sites nor the second spherical locus of potential sites of the nerve to identify the location; nor expressly discloses any specific imaging module comprising circuitry configured to acquire the image of the patient's anatomy disclosed by Kaula. Nor does Kaula explicitly disclose an imaging module configured to acquire the image of the patient's anatomy.
However, in the same field of endeavor, Byrd teaches a first spherical locus, a second spherical locus, determine an intersection of the first spherical locus of potential sites of a signal and the second spherical locus of potential sites of a signal to identify the location of the signal ([0022], [0027], [0029], [0040] an electrode is positioned at a known or fixed position on a probe, and a method for sensing a signal measuring a range Ri to determine a range or bearing to an emitter in combination with 1, 2, or more emitters in order to determine a 3D position of the sensor is easily calculated using well known methods as the intersection of three or more spheres of radius Ri each centered on each electrode);
an imaging module (abstract, claim 8, an imaging ultrasound sensor) configured to acquire an image of the patient's anatomy ([0043], [0058], claim 8, the ultrasound imaging sensor of the catheter is used for intra-cardiac ultrasound (and thus positioned somewhere in the right atrium of a patient's heart to generate images nearby inside the patient’s heart/anatomy); and
obtain the location of the signal from the determined intersection of the first spherical locus of potential sites and the second spherical locus of potential sites ([0022], [0027], [0029], the impedance between the emitter/signal source and sensing electrode on the catheter will change with distance to the emitter or signal source, the distance can be calculated using the well-known methods as the intersection of three or more spheres).
It would have been obvious to a person of ordinary skill in the art at the time of the invention to modify the apparatus and method disclosed by Kaula to include determining a 3D position of a nerve within a patient's body by using well known methods as the intersection of three or more spheres of radius each centered on each electrode and to include an imaging module configured to acquire an image of the patient's anatomy, and obtain the location from the determined intersection of the first spherical locus of potential sites and the second spherical locus of potential sites as taught by Byrd in order to localize medical devices positioned near or beyond the maximum path length of the particular tissue at a 3D position, thus providing the operator with more visual information, and thus a more easily understood representation of the position of the ultrasound catheters (see [0037]-[0039], [0058] of Byrd).
Kaula, in view of Byrd, specifically, Byrd discloses displaying a map of the patient’s anatomy (see claims 8, 11 the displaying an ultrasound image highlights a surface on the context map corresponding to the frame of the heart surface that is displayed in the ultrasonic image) using an imaging control module ([0047]-[0050] the controller 299 comprises an appropriately programmed microprocessor, an application specific integrated circuit (ASIC) or other similar control and calculation device); Kaula does not explicitly disclose the location of the signal being the location of the nerve, nor an overlay module configured to visually overlay a map of the location of the nerve on the image of the patient's anatomy.
However, in the same field of endeavor, Cory teaches obtain the location of the nerve from the determined intersection of the first spherical locus of potential sites of the nerve and the second spherical locus of potential sites of the nerve ([0111]-[0112], [0118], [0151], FIGS. 1-3, isocurrent lines are formed in planes intersecting the line of the current-carrying electrode at 90°, so that the location of the nerve is determined to be midway on the x-axis between a waveform electrode 1 and a return electrode 7, where only one electrode is a first electrode in that it sends out emissive signals, the image generation is performed by using the impedance determinations with different waveforms, the generated waveform is applied to an indiviual single waveform electrode);
an imaging module configured to acquire an image of the patient's anatomy ([0139], [0162], [0382], operating the system includes image interpretation guidance which is useful to the operator, the controller 16 may generate nerve tissue density distribution depicting x and y locators and a height related to the probability of nerve tissue under specific x, y coordinates to be displayed on the display 19 via use of image-guided equipment such as a CT scan, X-ray, MRI image, ultrasound scan or tissue discrimination scan);
an overlay module configured to visually overlay a map of the location of the nerve on the image of the patient's anatomy ([0162], FIGS. 1-3, the controller generates a nerve tissue density distribution or probability map depicting x and y locators and a height related to the probability of nerve tissue under specific x, y coordinates and the display may be operable to display such an image, which also includes data related to tissue depth included in the graphically indication/overlay of the detected location of nerve tissue).
It would have been obvious to one ordinarily skilled in the art before the effective filing date of the claimed invention to modify the apparatus and method disclosed by Kaula with the step of obtain the location of the nerve from the determined intersection of the first spherical locus of potential sites of the nerve and the second spherical locus of potential sites of the nerve, the imaging module configured to acquire an image of the patient's anatomy; and the overlay module configured to visually overlay a map of the location of the nerve on the image of the patient's anatomy as taught by Cory in order to provide the an assessment of the tissue of a subject, thereby completing an electrical circuit which includes the tissue of the subject as a component to determine information indicative of the voltage, current, and phase of the applied waveform; and calculating an electrical characteristic of the tissue of the test subject associated with the applied waveform and provide improved discrimination and resolution of tissues compared to any single imaging technology ([0054], [0226] of Cory).
*For the purposes of examination, the limitation has been interpreted under the broadest reasonable interpretation that while the determine steps are determined with respect to a first stimulation electrode, the apparatus may be inclusive additional electrodes other than the first electrode as known in the surgical navigation arts.
Regarding claims 22 and 32, Kaula substantially discloses all the limitations of the claimed invention, specifically, Kaula discloses wherein the control module is configured to provide electrical current from an electrical source to the first stimulation electrode ([0040], the surgical system 10 electrically stimulating nerves via one or more stimulation electrodes, wherein the electrode providing a path for the stimulation electrical current).
Regarding claims 27 and 37-38, Kaula, in view of Byrd, substantially discloses all the limitations of the claimed invention, specifically, Kaula discloses wherein the control module is further configured to determine a third locus of potential sites of the nerve equidistant from a third position of the first stimulation electrode when the first stimulation electrode stimulates the nerve (FIGS. 7, 13, [0065]-[0070], real-time monitoring of the distance of the 4 electrodes (inclusive of the first electrode) from the nerve further, specifically, including real-time monitoring of the distance of the first electrode from a nerve, as the probe is advanced/ repositioned though various positions (including third position, wherein each distance measurement represents a distance from the circle that represent denote the position of the electrode respective to the origin or center of the cannula, d denotes the distance to the nerve location that represent by octagon. The third spherical locus of potential sites of the nerve equidistant from a third position of the first stimulation electrode to the octagon which denotes the nerve location. As the operator selects any one of the 4 channels available to perform the direction function, thus reading on the limitation of the first electrode being used to determine the first position and the second position, respectively. A vector is drawn from the origin along the axis corresponding to the first electrode that has a length equal to IThresh for first electrode in order to compute the vector from the origin to a direction pointing toward the nerve, thus the cited disclose of Kaula reading on the limitation a third locus of potential sites of the nerve equidistant from a third position of a first stimulation electrode); wherein the first stimulation electrode has been repositioned such that the third position is different from the second position and different from the first position ([0064-[0070] the operator returns to the Detection Function to continue advancing/ reposition the instrument to the second position where the Direction Function can be determined, therefore, as the instrument is advanced and repositioned to the second position, it is reads on the limitation that the second position is different from the first position as the Direction function is performed at a physically separate location from the first position)
And specifically, Byrd discloses determine an intersection of the third spherical locus of potential sites of the nerve with at least one of the first spherical locus of the potential sites or the second spherical locus of potential sites of the nerve to identify the location of the nerve ([0022], [0025], [0029], [0040] an electric field sensor, such as an electrode, is positioned at a known or fixed position on a probe, and a method of measuring a range Ri to three or more electrodes, a 3D position of the sensor is easily calculated using well known methods as the intersection of three or more spheres of radius Ri centered on the catheter).
It would have been obvious to a person of ordinary skill in the art at the time of the invention to modify the apparatus and method disclosed by Kaula to include determining a 3D position of a nerve within a patient's body by using well known methods as the intersection of three or more spheres of radius each centered on each electrode taught by Byrd in order to localize medical devices positioned near or beyond the maximum path length of the particular tissue at a 3D position, thus providing the operator with more visual information, and thus a more easily understood representation of the position of the ultrasound catheters (see [0037]-[0039], [0058] of Byrd) to user of Kaula to visualize the nerve in 3D space and also determine the depth of the nerve based on the coordinate that represent the depth in 3D space.
Claims 23 and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Kaula, in view of Byrd and Cory, as applied to claims 21 and 31 above, further in view of Appenrodt et al. (US20080269777, hereafter “Appenrodt”).
Regarding claims 23 and 33, Kaula substantially discloses all the limitations of the claimed invention, specifically, Kaula discloses wherein the control module further comprises the first stimulation electrode and the second stimulation electrode (FIGS. 1, 7, [0065]-[0069], the control unit 12 including a real time monitoring of the distance of the four electrodes from a nerve as the probe is advanced through various positions including at each new position of the first stimulation electrode and the second stimulation electrode); but does not explicitly disclose an electrode positioning module configured to position the first stimulation electrode.
However, in the same field of endeavor, Appenrodt teaches an electrode positioning module configured to position the first stimulation electrode (FIGS. 1, 7, [0023], [0032], an electrode probe insertion device comprising a computer-controlled drive system 104).
It would have been obvious to one ordinarily skilled in the art before the effective filing date of the claimed invention to modify the apparatus and method disclosed by Kaula to include a drive system as taught by Appenrodt in order to control insertion and removal of an electrode (see [0023], [0032] of Appenrodt).
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.
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/A.S./Examiner, Art Unit 3798
/KEITH M RAYMOND/Supervisory Patent Examiner, Art Unit 3798