DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2-11 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 2 recites ‘locations and proximities of neural structures’ multiple times in the claim making it unclear if each recitation refers to the same element or not. For the purpose of this examination they will be treated as the same element.
Claim 2 recites ‘sequential variable multi-polar stimulation’ multiple times in the claim making it unclear if each recitation refers to the same element or not. For the purpose of this examination they will be treated as the same element.
Claim 2 recites the limitation "the first grid array" in Line 11 and 12. There is insufficient antecedent basis for this limitation in the claim. It appears this should read ‘the first grid array of electrodes’.
Claim 2 recites the limitation "the second grid array" in Line 17 and 18. There is insufficient antecedent basis for this limitation in the claim. It appears this should read ‘the first grid array of electrodes’.
Claim 2 recites "the evoked potential responses" multiple times in the claim making it unclear if each recitation refers to the same element or not. For the purpose of this examination they will be treated as the same element.
Claim 2 recites ‘combine information gathered’ and it is unclear what information this is referring to, and further when and how it is gathered. Further it is unclear what the information is being combined with. For examination purposes it will be merely treated as ‘receive the evoked potential responses to enable nerve mapping’
The term “different” in claim 3 is a relative term which renders the claim indefinite. The term “different” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
The term “specific” in claim 3 is a relative term which renders the claim indefinite. The term “specific” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim 3 recites the limitation "the respective first and second instruments" in Lines 3-4. There is insufficient antecedent basis for this limitation in the claim. It appears this should read ‘the first instrument and the second instrument’.
Claim 4 recites ‘locations and proximities of neural structures’ and is dependent back to claim 2 which recites the same making it unclear if each recitation refers to the same element or not. For the purpose of this examination they will be treated as the same element.
Claim 6 recites the limitation "the grid array" in Line 3, 4, 7, and 9. There is insufficient antecedent basis for this limitation in the claim.
Claim 6 recites the limitation "the electrodes" in Line 3. There is insufficient antecedent basis for this limitation in the claim. This similarly applies to ‘each electrode’.
Claim 6 recites the limitation "the instrument" in Lines 9 and 10. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites the limitation "the same" in Line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites ‘electrodes’ and ‘a grid array’ making it unclear if they are referring to any of the electrodes or the ‘first grid array of electrodes’ or the ‘second grid array of electrodes’ as recited in claim 2 or not.
Claim 11 recites ‘stimulation’ making it unclear if this is part of the ‘sequential variable multi-polar stimulation’ as recited in claim 2 or not. For examination purposes it will be treated as the same stimulation.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language.
Claim(s) 2, 4-5, 7-8, and 10-11 is/are rejected under pre-AIA 35 U.S.C. 102(e) as being anticipated by Gerber et al. (US 2012/0277621).
Regarding claim 2, Gerber teaches a nerve mapping system (Abstract) comprising:
a first instrument (one of 14 or 15) configured to be inserted into a tissue site of a patient to map locations and proximities of neural structures in the tissue site (Paragraph 0056; “which is coupled to implantable stimulation leads 14 and 15”; Figures 1A-1B), the first instrument comprising a surface on which a first grid array of electrodes is positioned (Figure 1B; Paragraph 0057: “via stimulation electrodes carried by leads 14 and 15.”; Paragraphs 0051 and 0095);
a second instrument (the other of 14 or 15) configured to be inserted into a tissue site of a patient to map locations and proximities of neural structures in the tissue site (Paragraph 0056; “which is coupled to implantable stimulation leads 14 and 15”; Figures 1A-1B), the second instrument comprising a surface on which a second grid array of electrodes is positioned (Figure 1B; Paragraph 0057: “via stimulation electrodes carried by leads 14 and 15.”; Paragraphs 0051 and 0095); and
a computer system (In combination elements 12, 28, and 26; Paragraph 0102) configured to:
cause delivery of sequential variable multi-polar stimulation to the electrodes of the first grid array of electrodes according to a plurality of stimulation configurations to scan the first grid array and elicit evoked potential responses (Paragraph 0028), wherein each of the electrodes of the first grid array is configured to be stimulated individually and independently to help determine locations and proximities of neural structures relative to the first instrument (Figures 10-12; Paragraphs 0148-0152);
cause delivery of sequential variable multi-polar stimulation to the electrodes of the second grid array of electrodes according to a plurality of stimulation configurations to scan the second grid array and elicit evoked potential responses (Paragraph 0028), wherein each of the electrodes of the second grid array is configured to be stimulated individually and independently to help determine locations and proximities of neural structures relative to the second instrument, and wherein a stimulation configuration to scan the first grid array of electrodes is different from a stimulation configuration to scan the second grid array of electrodes (Figures 10-12; Paragraphs 0044-0045 and 0048-0049 and 0148-0152); and
receive the evoked potential responses and combine information gathered based on the evoked potential responses to enable nerve mapping (step 122; Paragraph 0071; “Nerve mapping based on stimulation thresholds for electrodes connected to leads 14 and/or 15”; Figure 10).
Regarding claim 4, Gerber teaches wherein the computer system is further configured to: generate a virtual map of locations and proximities of neural structures in the tissue site based at least in part on the information gathered based on the evoked potential responses (Paragraphs 0071 and 0102 and 0156).
Regarding claim 5, Gerber teaches wherein the first instrument and second instrument are configured to be inserted into a tissue site of a patient sequentially, with either the first instrument or the second instrument at any time being an active instrument (Figure 1B; Paragraph 0073).
Regarding claim 7, Gerber teaches wherein the computer system is further configured to: output the virtual map for display on an electronic display (Paragraph 0102).
Regarding claim 8, Gerber teaches wherein the first instrument comprises one of: a probe, a tissue dilator, or a retractor system (Figures 6A-6B and 7).
Regarding claim 10, Gerber teaches wherein at least one of the first instrument or second instrument comprises a probe for peripheral nerve mapping (Paragraph 0004).
Regarding claim 11, Gerber teaches wherein the computer system is further configured to: adjust one or more stimulation parameters when causing delivery of stimulation to electrodes of a grid array, wherein the one or more stimulation parameters include at least one of: current level, voltage level, or pulse width (Paragraph 0005).
Claim Rejections - 35 USC § 103
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 though 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 negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Gerber et al. (US 2012/0277621).
Regarding claim 3, Gerber wherein the first grid array of electrodes comprises a first layout, wherein the second grid array of electrodes comprises a second layout, and wherein the first layout and second layout are different and specific to the respective first and second instruments (Figures 6A-6B and 7). Should this not be found explicit enough it would have been obvious to one of ordinary skill in the art to have modified Gerber to use the different layouts simultaneously since the layouts merely represent a shape design choice and so one of ordinary skill in the art at the time of invention would have found that the change in shape did not sufficiently alter the device as it was an obvious change motivated by manufacturing parameters or user preference. See re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1996).
Claim 6 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Gerber et al. (US 2012/0277621) in view of Cory et al. (US 2006/0085049).
Regarding claim 6, Gerber teaches wherein the virtual map includes:
a graphical representation of the active instrument including a graphical representation of the grid array of the active instrument and positions of the electrodes of the grid array of the active instrument overlaid on the graphical representation of the instrument (Paragraph 0156); and
Gerber is silent on the colors to indicate locations and proximities.
Cory teaches one or more colors overlaid on the graphical representation of the active instrument including the graphical representation of the grid array of electrodes of the active instrument, wherein the one or more colors indicate the locations and proximities of the neural structures in relation to the instrument and to each electrode of the grid array of electrodes on the surface of the instrument (Paragraph 0227).
It would have been obvious to one of ordinary skill in the art to have modified Gerber with Cory because it allows for an easy to understand display to convey the results (Paragraph 0227 of Cory).
Claim 9 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Gerber et al. (US 2012/0277621) in view of Rasmussen (US 2011/0270119).
Regarding claim 9, Gerber teaches wherein the second instrument comprises one of: a probe, a tissue dilator, or a retractor system (Figures 6A-6B and 7; probe), Rasmussen teaches the second instrument being a dilator (Paragraph 0011) and thus in combination Gerber and Rasmussen teaches wherein the second instrument is not the same as the first instrument (Paragraph 0011 of Rasmussen and Figures 6A-6B and 7 of Gerber). It would have been obvious to one of ordinary skill in the art to have modified Gerber with Rasmussen because it allows access to different muscles to better facilitate nerve mapping (Paragraphs 0001-0003 and 0017 if Rasmussen).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 2-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12029565. The overlapping subject matter is shown in the chart below. The only difference between the instant application and the conflicting patent is that the instant application has two instruments with two grid arrays of electrodes for the stimulation. It would have been obvious to one of ordinary skill in the art to have modified the patent to have two instruments with two grid arrays of electrodes for the stimulation since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8. MPEP 2144.04(VI-B).
Instant Application 18/673,831
US Patent No. 12029565
2. (New) A nerve mapping system comprising:
a first instrument configured to be inserted into a tissue site of a patient to map locations and proximities of neural structures in the tissue site, the first instrument comprising a surface on which a first grid array of electrodes is positioned;
a second instrument configured to be inserted into a tissue site of a patient to map locations and proximities of neural structures in the tissue site, the second instrument comprising a surface on which a second grid array of electrodes is positioned; and
a computer system configured to:
cause delivery of sequential variable multi-polar stimulation to the electrodes of the first grid array of electrodes according to a plurality of stimulation configurations to scan the first grid array and elicit evoked potential responses, wherein each of the electrodes of the first grid array is configured to be stimulated individually and independently to help determine locations and proximities of neural structures relative to the first instrument;
cause delivery of sequential variable multi-polar stimulation to the electrodes of the second grid array of electrodes according to a plurality of stimulation configurations to scan the second grid array and elicit evoked potential responses, wherein each of the electrodes of the second grid array is configured to be stimulated individually and independently to help determine locations and proximities of neural structures relative to the second instrument, and wherein a stimulation configuration to scan the first grid array of electrodes is different from a stimulation configuration to scan the second grid array of electrodes; and
receive the evoked potential responses and combine information gathered based on the evoked potential responses to enable nerve mapping.
1. A nerve mapping system comprising:
a computer system configured to:
cause delivery of sequential variable multi-polar stimulation to electrodes of a grid array of electrodes according to a plurality of stimulation configurations to scan the grid array and elicit evoked potential responses,
wherein the plurality of stimulation configurations include at least mono-polar, bi-polar, and tri-polar stimulation configurations of different electrodes of the grid array, and wherein the electrodes are positioned on a surface of an instrument configured to be inserted into a tissue site of a patient to map locations and proximities of neural structures in the tissue site; and
receive the evoked potential responses and combine information gathered based on the evoked potential responses to enable nerve mapping.
Claims 2-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10973451. The overlapping subject matter is shown in the chart below. The only difference between the instant application and the conflicting patent is that the instant application has two instruments with two grid arrays of electrodes for the stimulation. It would have been obvious to one of ordinary skill in the art to have modified the patent to have two instruments with two grid arrays of electrodes for the stimulation since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8. MPEP 2144.04(VI-B).
Instant Application 18/673,831
US Patent No. 10973451
2. (New) A nerve mapping system comprising:
a first instrument configured to be inserted into a tissue site of a patient to map locations and proximities of neural structures in the tissue site, the first instrument comprising a surface on which a first grid array of electrodes is positioned;
a second instrument configured to be inserted into a tissue site of a patient to map locations and proximities of neural structures in the tissue site, the second instrument comprising a surface on which a second grid array of electrodes is positioned; and
a computer system configured to:
cause delivery of sequential variable multi-polar stimulation to the electrodes of the first grid array of electrodes according to a plurality of stimulation configurations to scan the first grid array and elicit evoked potential responses, wherein each of the electrodes of the first grid array is configured to be stimulated individually and independently to help determine locations and proximities of neural structures relative to the first instrument;
cause delivery of sequential variable multi-polar stimulation to the electrodes of the second grid array of electrodes according to a plurality of stimulation configurations to scan the second grid array and elicit evoked potential responses, wherein each of the electrodes of the second grid array is configured to be stimulated individually and independently to help determine locations and proximities of neural structures relative to the second instrument, and wherein a stimulation configuration to scan the first grid array of electrodes is different from a stimulation configuration to scan the second grid array of electrodes; and
receive the evoked potential responses and combine information gathered based on the evoked potential responses to enable nerve mapping.
1. A nerve mapping and monitoring system comprising:
a grid array of a plurality of electrodes positioned on a surface of a surgical instrument configured to be inserted into a tissue site of a patient to map locations and proximities of neural structures in the tissue site,
wherein: each of the plurality of electrodes is configured to be stimulated individually and independently, and every one of the plurality of electrodes is configured to be stimulated as part of at least mono-polar, bi-polar, and tri-polar stimulation configurations; and
a computer system configured to cause delivery of sequential variable multi-polar stimulation to electrodes of the grid array according to a plurality of stimulation configurations to scan the grid array and elicit evoked potential responses, wherein the plurality of stimulation configurations include at least mono-polar, bi-polar, and tri-polar stimulation configurations of different electrodes of the grid array.
2. The nerve mapping and monitoring system of claim 1, wherein the computer system is further configured to monitor the evoked potential responses and combine information gathered based on the evoked potential responses to generate a virtual map of locations and proximities of neural structures in the tissue site so as to enable nerve mapping and monitoring.
Claims 2-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 10016142. The overlapping subject matter is shown in the chart below. The only difference between the instant application and the conflicting patent is that the instant application has two instruments with two grid arrays of electrodes for the stimulation. It would have been obvious to one of ordinary skill in the art to have modified the patent to have two instruments with two grid arrays of electrodes for the stimulation since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8. MPEP 2144.04(VI-B).
Instant Application 18/673,831
US Patent No. 10016142 Claim 1
US Patent No. 10016142 Claim 16
US Patent No. 10016142 Claim 17
2. (New) A nerve mapping system comprising:
a first instrument configured to be inserted into a tissue site of a patient to map locations and proximities of neural structures in the tissue site, the first instrument comprising a surface on which a first grid array of electrodes is positioned;
a second instrument configured to be inserted into a tissue site of a patient to map locations and proximities of neural structures in the tissue site, the second instrument comprising a surface on which a second grid array of electrodes is positioned; and
a computer system configured to:
cause delivery of sequential variable multi-polar stimulation to the electrodes of the first grid array of electrodes according to a plurality of stimulation configurations to scan the first grid array and elicit evoked potential responses, wherein each of the electrodes of the first grid array is configured to be stimulated individually and independently to help determine locations and proximities of neural structures relative to the first instrument;
cause delivery of sequential variable multi-polar stimulation to the electrodes of the second grid array of electrodes according to a plurality of stimulation configurations to scan the second grid array and elicit evoked potential responses, wherein each of the electrodes of the second grid array is configured to be stimulated individually and independently to help determine locations and proximities of neural structures relative to the second instrument, and wherein a stimulation configuration to scan the first grid array of electrodes is different from a stimulation configuration to scan the second grid array of electrodes; and
receive the evoked potential responses and combine information gathered based on the evoked potential responses to enable nerve mapping.
1. A nerve mapping and monitoring system comprising:
a multi-polar stimulation unit;
a grid array of electrodes integrated onto a surface of a surgical instrument configured to be inserted into a tissue site of a patient to map locations of neural structures in the tissue site, wherein:
the grid array of electrodes comprises a plurality of electrodes, each of the plurality of electrodes is configured to be individually and independently electrified by the multi-polar stimulation unit including independent control of a respective polarity and respective one or more stimulation parameters of each of the plurality of electrodes, and every one of the plurality of electrodes is configured to be stimulated as part of at least mono-polar, bi-polar, and tri-polar stimulation configurations;
an electrical connector having a first end and a second end, wherein the first end is configured to be removably coupled with the multi-polar simulation unit, and wherein the second end is configured to be removably coupled to the grid array of electrodes;
a computer system configured to cause the multi-polar stimulation unit to deliver bursts of electrical current to the grid array of electrodes integrated onto the surface of the surgical instrument to individually and independently electrify electrodes of the plurality of electrodes, wherein the computer system is further configured to cause the multi-polar stimulation unit to deliver the bursts of electrical current to the grid array of electrodes in a plurality of sequences using sequential stimulations of varying combinations of electrodes at different regions on the grid array to build a virtual map of locations and proximities of neural structures in the tissue site, wherein the sequential stimulations are defined by a plurality of stimulation configurations including at least mono-polar, bi-polar, and tri-polar stimulation configurations of different electrodes on the grid array of electrodes in order to produce variable electrical current densities in biological tissues adjacent to the grid array of electrodes on the surgical instrument in the tissue site and in order to enable detection of evoked potential responses from any nerves that may be located in proximity to the surgical instrument, wherein any given stimulation configuration and stimulation parameters may or may not activate nearby neural structures which may or may not produce evoked potential responses that can be recorded and analyzed with a differential amplification recording system using evoked potential recording techniques, wherein each combination of electrodes is stimulated simultaneously for any given stimulation configuration;
a recording element comprising a differential amplification recording system capable of recording and digitizing a brief epoch of time following each individual burst of electrical current delivered to the grid array of electrodes, wherein the recording element is configured to detect any evoked potential responses that might be elicited from electrical activation of neural structures located in proximity to the particular combination of electrodes stimulated;
the computer system further configured to mathematically analyze digitized information obtained from the recording element to detect and quantify any evoked potential responses associated with each particular stimulation configuration, wherein the computer system is configured to use evoked potential thresholding techniques to sequentially scan through multiple permutations of stimulation configurations and stimulation parameters to mathematically determine which stimulation configuration(s) yield lowest threshold evoked potential responses; and
a video monitor or other audiovisual feedback device, wherein the computer system is configured to output to the video monitor or other audiovisual feedback device a virtual map generated by at least sequentially stimulating the varying combinations of electrodes utilizing at least the mono-polar, bi-polar, and tri-polar stimulation configurations and utilizing detected and quantified evoked potential responses associated with each particular stimulation configuration, so as to provide useful information that could alert a surgeon to the presence of nearby neural structures in proximity to the surgical instrument, provide the surgeon with information to assist in estimating a proximity of the neural structures in relation to the surgical instrument, and/or provide information describing a relative direction of a location of neural structures in relation to the grid array of electrodes,
wherein at least two of the plurality of stimulation configurations define first and second mono-polar configurations that include at least a first one or more electrodes on the surface of the surgical instrument that are stimulated simultaneously when the first mono-polar configuration is utilized by the computer system, and at least a second one or more electrodes on the surface of the surgical instrument different from the at least a first one or more electrodes that are stimulated simultaneously when the second mono-polar configuration is utilized by the computer system,
wherein at least one of the plurality of stimulation configurations defines a bi-polar configuration that includes at least a first two electrodes on the surface of the surgical instrument that are stimulated simultaneously when the bi-polar configuration is utilized by the computer system, wherein at least one of the plurality of stimulation configurations defines a first tri-polar configuration that includes at least a first three electrodes on the surface of the surgical instrument that are linearly arranged and stimulated simultaneously when the first tri-polar configuration is utilized by the computer system, and
wherein at least one of the plurality of stimulation configurations defines a second tri-polar configuration that includes at least a second three electrodes on the surface of the surgical instrument that are not linearly arranged and stimulated simultaneously when the second tri-polar configuration is utilized by the computer system.
16. A nerve mapping and monitoring system comprising:
a multi-polar stimulation unit;
an electrical cable having a first end and a second end, wherein the first end is configured to be electrically coupled with the multi-polar simulation unit;
a surgical instrument configured to be inserted into a tissue site of a patient to map locations of neural structures in the tissue site, wherein the surgical instrument is configured to be electrically coupled to the second end of the electrical cable to enable electrical communication between the multi-polar stimulation unit and the surgical instrument;
a grid array of individually and independently stimulateable plurality of electrodes, the grid array of electrodes being positioned on a surface of a lower portion of the surgical instrument configured to be inserted into the tissue site of the patient, wherein: each of the plurality of electrodes is configured to be stimulated individually and independently by the multi-polar stimulation unit, and every one of the plurality of electrodes is configured to be stimulated as part of at least mono-polar, bi-polar, and tri-polar stimulation configurations;
a recording element, wherein the recording element is configured to detect evoked potential responses elicited by stimulation of combinations of electrodes of the grid array of electrodes according to a plurality of stimulation configurations;
a computer system configured to monitor the evoked potential responses and combine information gathered based on the evoked potential responses to generate a virtual map of locations and proximities of neural structures in the tissue site so as to enable nerve mapping and monitoring and such that neural structures can be detected, monitored, identified, and/or avoided; and
a display, wherein the display is configured to visually represent the virtual map of locations and proximities of neural structures in the tissue site,
the multi-polar stimulation unit configured to, in response to signals provided by the computer system, cause delivery of sequential variable multi-polar stimulation to specific electrodes of the grid array of electrodes according to the plurality of stimulation configurations to scan the grid array and elicit the evoked potentials, wherein the plurality of stimulation configurations include at least mono-polar, bi-polar, and tri-polar stimulation configurations of different electrodes on the grid array of electrodes.
17. A nerve mapping and monitoring system comprising:
a grid array of electrodes configured to be positioned on a surface of a surgical instrument, wherein: the surgical instrument is configured to be inserted into a tissue site of a patient to map locations of neural structures in the tissue site, the grid array of electrodes comprises a plurality of electrodes that are individually and independently stimulateable, and every one of the plurality of electrodes is configured to be stimulated as part of at least mono-polar, bi-polar, and tri-polar stimulation configurations; and
a computer-readable medium storing software code, wherein the software code is configured, when executed by a computer processor, to cause the nerve mapping and monitoring system to:
initiate a sequence of plurality of stimulation configurations, wherein: the plurality of stimulation configurations include at least mono-polar, bi-polar, and tri-polar stimulation configurations of different electrodes on the grid array of electrodes, and each of the plurality of stimulation configurations is configured to cause simultaneous activation of a different combination of electrodes at different regions on the grid array to enable generating a virtual map of locations and proximities of neural structures in the tissue site;
cause activation of a first tri-polar stimulation configuration including a first combination of electrodes of the grid array of electrodes, wherein: at least a first electrode of the first combination of electrodes is activated at a first polarity, at least a second electrode of the first combination of electrodes is activated at a second polarity different from the first polarity, at least a third electrode of the first combination of electrodes is activated at least one of the first polarity or the second polarity, all of the electrodes of the first combination of electrodes are activated simultaneously, and the first combination of electrodes are arranged linearly on the surface of the surgical instrument;
receive a first indication of an evoked potential response associated with the activation of the first combination of electrodes to enable nerve mapping and monitoring and generate a portion of the virtual map of locations and proximities of neural structures in the tissue site;
cause activation of a second tri-polar stimulation configuration including a second combination of electrodes of the grid array of electrodes, wherein: the second combination of electrodes comprises a different combination from the first combination of electrodes, at least a first electrode of the second combination of electrodes is activated at the first polarity, at least a second electrode of the second combination of electrodes is activated at the second polarity, at least a third electrode of the second combination of electrodes is activated at at least one of the first polarity or the second polarity, and all of the electrodes of the second combination of electrodes are activated simultaneously, and the second combination of electrodes are arranged non-linearly on the cylindrical surface of the surgical instrument; receive a second indication of an evoked potential response associated with the activation of the second combination of electrodes to enable nerve mapping and monitoring and generate a further portion of the virtual map of locations and proximities of neural structures in the tissue site; cause activation of an additional stimulation configuration comprising at least one of: a third tri-polar configuration, a bi-polar configuration, or a mono-polar configuration, wherein the additional stimulation configuration is activated subsequent to the activation of the first and second tri-polar configurations;
receive a third indication of an evoked potential response associated with the activation of the additional stimulation configuration to enable nerve mapping and monitoring and further enhance the virtual map of locations and proximities of neural structures in the tissue site; and
generate, based on at least the first second, and third indications, a visualization of the virtual map of locations and proximities of neural structures in the tissue site indicating a proximity of neural structures to the grid array of electrodes positioned on the surface of the surgical instrument.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Gliner et al. (US Patent No. 7305268).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PATRICK FERNANDES whose telephone number is (571)272-7706. The examiner can normally be reached Monday-Thursday 9AM-3PM EST.
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/PATRICK FERNANDES/Primary Examiner, Art Unit 3791
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