DETAILED ACTION
This office action is responsive to the amendment filed 7/22/2026. Claims 21-40 remain pending and under prosecution.
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
a stimulation module – Claim 21, 31, 40
a control module – Claim 23, 31, 40
a feedback module – Claim 29, 37
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 28 and 36 rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. The claims recite limitations already recited in the independent claims.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 21-40 are rejected under 35 U.S.C. 103 as being unpatentable over Thrope et al (US Pub No. 20060200219 – cited by applicant) in view of Davis et al (US Pub No. 20100286554) and Hacker et al (US Pat No. 7216001 – cited by applicant).
In regard to Claim 21, Thrope et al disclose a bipolar stimulation probe, comprising:
a housing 16 (handle), best seen in Figure 2B;
an elongated member 18 extending from the housing and including a first electrode 22, 42 and a second electrode 24, 44, the first electrode spaced apart from the second electrode on the elongated member, best seen in Figure 2B and 3A, 3B, 3C (0016-0018, 0028);
a memory housed in the housing and configured to store one or more stimulation parameters, the memory necessarily found in on-board, programmable microprocessor –
“control circuitry 28 desirably includes an on-board, programmable microprocessor, which carries embedded code. The code expresses pre-programmed rules or algorithms for generating the desired electrical stimulation waveforms… [e.g.] stimulus frequency is 20 Hz, (although the frequency may be adjustable, e.g., 3 Hz to 100 Hz), and the waveform comprises a charge balanced biphasic waveform (i.e., no net DC current flow)” (0032),
“electrical stimulation control circuitry 28 is carried within the handle 16 (see FIGS. 2A and 2B)” (0031);
a stimulation module 28 configured to stimulate nerve tissue of a patient by generating a first and a second pulse to be output from at least the first electrode – “control circuitry 28 generates a stimulation current which is applied through the contacts 22 and 24” (0031),
the first pulse and the second pulse being generated based on the one or more stimulation parameters recalled from the memory – “The code expresses pre-programmed rules or algorithms for generating the desired electrical stimulation waveforms” (0032); and
a transceiver (shown by wire-like lines in Figure 1) necessarily in communication with a nerve integrity monitoring device 14 configured to analyze the first and second pulses – “The first device 12 [probe] is located and relocated (if necessary) until the monitored physiologic response indicated by the second device 14 matches or approximates the anticipated physiologic response” (0047). Additionally, it is noted that the prior art is replete with evidence that electrical stimulation probes comprising transceivers are well-known in the nerve monitoring art.
However, Thrope et al do not expressly disclose the stimulation module is configured to generate a first pulse to be output from the first electrode and a second pulse to be output from the second electrode, wherein the first and second pulses are output in opposite directions along the nerve tissue, are monophasic, and are each a selected one of positive or negative.
Davis et al teach that it is well-known in the art to provide an analogous nerve stimulation device for nerve monitoring with a control module defined by neuromonitoring machine 602, best seen in Figure 15-16, that comprises all hardware and software required for the recited functions – “The suitable neuromonitoring machine 602 includes hardware and software capable of being programmed in accordance with the disclosed methods herein to generate an electrical stimulus, receive and process electrical signals generated by muscle or nerve tissues, and display in graphical form the response and compare the response signal to a baseline signal… includes any additional accessories, software drivers and modules, and electrical components to connect to a stimulator/amplifier (slave box) and/or the various nerve and EMG or myotome or dermatome probes and electrodes” (0072).
Thus, Davis et al teach a stimulation module within neuromonitoring machine 602 to output a first pulse from first electrode 1216A in the manner shown in Figure 15, and to output a second pulse from second electrode 1216B in the manner shown in Figure 16.
Specifically, when providing a proximal to distal nerve conduction in Figure 15, “the first electrode 1216A is stimulating the nerve at a location proximal to the surgical site. In the second distal slave box 1200B, the switch 1226B is shown so that the active contact of the differential amplifier circuit 1202B is connected to the first distal probe 1216B and the reference contact of the differential amplifier circuit 1202B is connected to the second distal electrode 1218B. The neuromonitoring machine 602 can then send a stimulus at the proximal anode electrode 1216A and receive the response at the distal active electrode 1216B, thus allowing proximal to distal nerve conduction” (0105). The proximal to distal nerve conduction provides a stimulation pulse from a proximal to distal direction.
In Figure 16, the stimulation module within neuromonitoring machine 602 provides a distal to proximal nerve conduction, which is opposite that in Figure 15 – “FIG. 16 is provided to illustrate conducting distal to proximal nerve conduction studies… by operating the switches 1226A, 1226B on the respective first and second slave boxes 1200A, 1200B to a second position. The first distal electrode 1216B of the distal slave box 1200B can then be connected to the anode contact of the stimulator circuit 1204B… The first proximal electrode 1216A of the proximal slave box 1200A can then be connected to the active contact of the differential amplifier circuit 1202A” (0105). Thus, this configuration switches the first 1216A and second 1216B electrode such that the stimulus is sent and thus outputs at anode 1216B; whereas in the configuration of Figure 15, the anode is designated as the first electrode 1216A, which outputs the stimulus. The configuration in Figure 15 and 16 thus output stimulation pulses in opposite directions along the nerve tissue, i.e. proximal to distal vs. distal to proximal, respectively.
Davis et al teach that switching mechanism comprising the control module and stimulation module within neuromonitoring machine 602 allows “a proximal electrode can be used in proximal to distal nerve conduction or EMG studies as a proximal stimulator electrode, and the same proximal electrode can be used as an active receiver electrode in distal to proximal nerve conduction studies. Similarly, a distal electrode can be used in distal to proximal nerve conduction studies as a distal stimulator electrode, and the same distal electrode can be used as an active receiver electrode in proximal to distal nerve conduction studies. This advantageously allows for testing to be conducted from proximal to distal and from distal to proximal by the operation of a switch and without disconnecting and reconnecting the probes” (0105).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Thrope et al such that the stimulation module is configured to generate a first pulse to be output from the first electrode and a second pulse to be output from the second electrode, wherein the first and second pulses are output in opposite directions along the nerve tissue in the manner taught by Davis et al to provide both proximal to distal as well as distal to proximal stimulus pulses to the nerves for the desired conduction study without having to disconnect and reconnect/reposition the probe of Thrope et al.
Hacker et al teach that it is well-known in the art to provide an analogous nerve stimulation device for nerve monitoring with a bipolar electrode stimulating probe that sends monophasic pulses and are each a selected one of positive or negative as desired – “the stimulator may alternatively be activated to deliver a complete cycle of monophasic electrical stimulation comprising a selected number of pulses that are all positive phase or all negative phase… The intraoperative neural monitoring system may also include a patient interface unit electrically connectible with the power source for delivering electrical stimulation to the patient via a monopolar or bipolar stimulating probe” (Col.5: 42-65).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Thrope et al as modified by Davis et al such that the pulses are monophasic and are each a selected one of positive or negative as taught by Hacker et al as an effective stimulation pulse as desired for the nerve monitoring.
22. Davis et al disclose the bipolar stimulation probe according to claim 21, further comprising: a first switch 1226A electrically connected to the first electrode 1216A, best seen in Figure 15-16 (0105); and
a second switch 1226B electrically connected to the second electrode 1216B, best seen in Figure 15-16 (0105).
23. Davis et al disclose the bipolar stimulation probe according to claim 22, further comprising a control module 602 electrically connected to the first and second switches 1226A-B, best seen in Figure 15-16 (0105),
wherein a switch control signal generated by the control module 602 is configured to change a state of the first and second switches to cause output of the first and second pulses from the respective first and second electrodes in opposite directions along the nerve tissue in the manner elaborated above (0105). Davis et al disclose “the switches 1226A, 1226B can be "soft" switches and are controlled by software running on the neuromonitoring machine 602” (0105).
24, 32. Davis et al disclose the bipolar stimulation probe according to claim 23 or 31, wherein the switch control signal generated by the control module 602 changes an operating mode of the bipolar stimulation probe, i.e. proximal to distal nerve conduction vs. distal to proximal nerve conduction, best seen in Figure 15-16 (0105).
25, 33. Davis et al disclose the bipolar stimulation probe according to claim 24 or 32, wherein: in a first mode of operation of the bipolar stimulation probe,
(i) the first switch 1226A is in a first state and the first pulse is delivered to the first electrode 1216A through the first switch (when it acts as the anode), and (ii) the second switch 1226B is in a first state and receives return current from the patient, best seen in Figure 15 as described with claim 1 (0105); and
in a second mode of operation of the bipolar stimulation probe, (i) the second switch 1226B is in a second state, best seen in Figure 16, and the second pulse is delivered to the second electrode 1216B through the second switch (when it acts as the anode), and (ii) the first switch 1226A is in a second state and receives return current from the patient, best seen in Figure 16 as described with claim 1 (0105).
26, 39. Thrope et al disclose the bipolar stimulation probe according to claim 21 or 31, wherein the first and second pulses are supplied from a single power source, i.e. a battery (0031).
27, 35. Davis et al disclose the bipolar stimulation probe according to claim 21 or 31, wherein the stimulation module 602 is configured to cause each of the first 1216A and second electrodes 1216B to alternate between operation as a cathode and operation as an anode because in Figure 15, the first electrode 1216A acts as an anode and in Figure 16, the second electrode 1216B act as an anode (0105). In both figures the other of the electrodes which receives the pulse after receiving it from the sending electrode is thus considered a cathode. It is noted that the definitions may be reversed, because either way the current of the electrical stimulus must flow from the first to second electrode or vice versa.
28, 36. Hacker et al disclose the bipolar stimulation probe according to claim 21 or 31, wherein the first and second pulses are both positive or both negative – “the stimulator may alternatively be activated to deliver a complete cycle of monophasic electrical stimulation comprising a selected number of pulses that are all positive phase or all negative phase” (Col.5: 42-65).
29, 37. Davis et al disclose the bipolar stimulation probe according to claim 21 or 31, further comprising a feedback module within neuromonitoring machine 602 configured to detect a first voltage across the first electrode 1216A and the second electrode 1216B during generation of the first pulse and detect a second voltage across the first electrode and the second electrode during generation of the second pulse – “the voltage, amperage, frequency, and duration or pulse width of each stimulus can be controlled with the neuromonitoring machine 602” (0071); “neuromonitoring machine 602 includes hardware and software capable of being programmed in accordance with the disclosed methods herein to generate an electrical stimulus, receive and process electrical signals generated by muscle or nerve tissues, and display in graphical form the response and compare the response signal to a baseline signal” (0072).
30, 38. Thrope et al disclose the bipolar stimulation probe according to claim 21 or 31, further comprising a light disposed on the housing 16 and configured to indicate contact between the nerve tissue and at least one of the first 22, 42 or second 24, 44 electrodes – “Through the use of different tones, colors, different flash rates, etc., the control circuitry 28 can allow the clinician to confirm that the probe is in contact with tissue” (0040).
31 and 40. Thrope et al disclose a bipolar stimulation probe, comprising:
a housing 16 (handle), best seen in Figure 2B;
an elongated member 18 extending from the housing and including a first electrode 22, 42 and a second electrode 24, 44, the first electrode spaced apart from the second electrode on the elongated member, best seen in Figure 2B and 3A, 3B, 3C (0016-0018, 0028);
a memory housed in the housing and configured to store one or more stimulation parameters, the memory necessarily found in on-board, programmable microprocessor –
“control circuitry 28 desirably includes an on-board, programmable microprocessor, which carries embedded code. The code expresses pre-programmed rules or algorithms for generating the desired electrical stimulation waveforms… [e.g.] stimulus frequency is 20 Hz, (although the frequency may be adjustable, e.g., 3 Hz to 100 Hz), and the waveform comprises a charge balanced biphasic waveform (i.e., no net DC current flow)” (0032),
“electrical stimulation control circuitry 28 is carried within the handle 16 (see FIGS. 2A and 2B)” (0031);
a stimulation module 28 configured to stimulate nerve tissue of a patient by generating a first and a second pulse to be output from at least the first electrode – “control circuitry 28 generates a stimulation current which is applied through the contacts 22 and 24” (0031),
the first pulse and the second pulse being generated based on the one or more stimulation parameters recalled from the memory – “The code expresses pre-programmed rules or algorithms for generating the desired electrical stimulation waveforms” (0032); and
a control module 28 defined as on-board, programmable microprocessor housed in the housing and electrically connected to switches 34, 32, 30 to control the stimulation pulses as desired, best seen in Figure 2B (0034-0037) – “control circuitry 28 desirably includes an on-board, programmable microprocessor, which carries embedded code” (0032),
“electrical stimulation control circuitry 28 is carried within the handle 16 (see FIGS. 2A and 2B)” (0031).
However, Thrope et al do not expressly disclose a first switch electrically connected to the first electrode; a second switch electrically connected to the second electrode; wherein a switch control signal generated by the control module is configured to change a state of the first and second switches to cause output of the first and second pulses from the respective first and second electrodes in opposite directions along the nerve tissue, the stimulation module is configured to generate a first pulse to be output from the first electrode and a second pulse to be output from the second electrode, wherein the first and second pulses are output in opposite directions along the nerve tissue, are monophasic, and are each a selected one of positive or negative.
Davis et al teach that it is well-known in the art to provide an analogous nerve stimulation device for nerve monitoring with control module defined by neuromonitoring machine 602, best seen in Figure 15-16, that comprises all hardware and software required for the recited functions – “The suitable neuromonitoring machine 602 includes hardware and software capable of being programmed in accordance with the disclosed methods herein to generate an electrical stimulus, receive and process electrical signals generated by muscle or nerve tissues, and display in graphical form the response and compare the response signal to a baseline signal… includes any additional accessories, software drivers and modules, and electrical components to connect to a stimulator/amplifier (slave box) and/or the various nerve and EMG or myotome or dermatome probes and electrodes” (0072).
Thus, Davis et al teach a stimulation module within neuromonitoring machine 602 to output a first pulse from first electrode 1216A in the manner shown in Figure 15 using first switch 1226A electrically connected to the first electrode, and to output a second pulse from second electrode 1216B in the manner shown in Figure 16 using a second switch 1226B electrically connected to the second electrode.
Specifically, when providing a proximal to distal nerve conduction in Figure 15, “the first electrode 1216A is stimulating the nerve at a location proximal to the surgical site. In the second distal slave box 1200B, the switch 1226B is shown so that the active contact of the differential amplifier circuit 1202B is connected to the first distal probe 1216B and the reference contact of the differential amplifier circuit 1202B is connected to the second distal electrode 1218B. The neuromonitoring machine 602 can then send a stimulus at the proximal anode electrode 1216A and receive the response at the distal active electrode 1216B, thus allowing proximal to distal nerve conduction” (0105). The proximal to distal nerve conduction provides a stimulation pulse from a proximal to distal direction.
In Figure 16, the stimulation module within neuromonitoring machine 602 provides a distal to proximal nerve conduction, which is opposite that in Figure 15 – “FIG. 16 is provided to illustrate conducting distal to proximal nerve conduction studies… by operating the switches 1226A, 1226B on the respective first and second slave boxes 1200A, 1200B to a second position. The first distal electrode 1216B of the distal slave box 1200B can then be connected to the anode contact of the stimulator circuit 1204B… The first proximal electrode 1216A of the proximal slave box 1200A can then be connected to the active contact of the differential amplifier circuit 1202A” (0105). Thus, this configuration switches the first 1216A and second 1216B electrode such that the stimulus is sent and thus outputs at anode 1216B; whereas in the configuration of Figure 15, the anode is designated as the first electrode 1216A, which outputs the stimulus. The configuration in Figure 15 and 16 thus output stimulation pulses in opposite directions along the nerve tissue, i.e. proximal to distal vs. distal to proximal, respectively.
Davis et al teach that switching mechanism comprising the control module and stimulation module within neuromonitoring machine 602 allows “a proximal electrode can be used in proximal to distal nerve conduction or EMG studies as a proximal stimulator electrode, and the same proximal electrode can be used as an active receiver electrode in distal to proximal nerve conduction studies. Similarly, a distal electrode can be used in distal to proximal nerve conduction studies as a distal stimulator electrode, and the same distal electrode can be used as an active receiver electrode in proximal to distal nerve conduction studies. This advantageously allows for testing to be conducted from proximal to distal and from distal to proximal by the operation of a switch and without disconnecting and reconnecting the probes” (0105).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Thrope et al such that the stimulation module is configured to generate a first pulse to be output from the first electrode and a second pulse to be output from the second electrode, wherein the first and second pulses are output in opposite directions along the nerve tissue, using a first switch electrically connected to the first electrode, a second switch electrically connected to the second electrode, and a switch control signal generated by the control module is configured to change a state of the first and second switches to cause output of the first and second pulses from the respective first and second electrodes in opposite directions along the nerve tissue, as taught by Davis et al to provide both proximal to distal as well as distal to proximal stimulus pulses to the nerves for the desired conduction study without having to disconnect and reconnect/reposition the probe of Thrope et al.
Hacker et al teach that it is well-known in the art to provide an analogous nerve stimulation device for nerve monitoring with a bipolar electrode stimulating probe that sends monophasic pulses and are each a selected one of positive or negative as desired – “the stimulator may alternatively be activated to deliver a complete cycle of monophasic electrical stimulation comprising a selected number of pulses that are all positive phase or all negative phase… The intraoperative neural monitoring system may also include a patient interface unit electrically connectible with the power source for delivering electrical stimulation to the patient via a monopolar or bipolar stimulating probe” (Col.5: 42-65).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Thrope et al as modified by Davis et al such that the pulses are monophasic and are each a selected one of positive or negative as taught by Hacker et al as an effective stimulation pulse as desired for the nerve monitoring.
34. Thrope et al disclose the bipolar stimulation probe according to claim 31, further comprising a transceiver (shown by wire-like lines in Figure 1) necessarily in communication with a nerve integrity monitoring device 14 configured to analyze the first and second pulses – “The first device 12 [probe] is located and relocated (if necessary) until the monitored physiologic response indicated by the second device 14 matches or approximates the anticipated physiologic response” (0047). Additionally, it is noted that the prior art is replete with evidence that electrical stimulation probes comprising transceivers are well-known in the nerve monitoring art.
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 21-28, 31-36, and 39-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of U.S. Patent No. 11980465 in view of Thrope et al.
The Patent discloses a bipolar stimulation probe, comprising: a housing;
an elongated member extending from the housing and including a first electrode and a second electrode, the first electrode spaced apart from the second electrode on the elongated member;
a stimulation module configured to stimulate nerve tissue of a patient by generating a first pulse to be output from the first electrode and a second pulse to be output from the second electrode, wherein the first and second pulses are monophasic, are selected one of either positive or negative, and are output in opposite directions along the nerve tissue; and
a transceiver (i.e. physical layer module of Patent) in communication with a nerve integrity monitoring device configured to analyze the first and second pulses;
a first switch electrically connected to the first electrode and a second switch electrically connected to the second electrode;
a control module electrically connected to the first and second switches, wherein a switch control signal generated by the control module is configured to change a state of the first and second switches to cause output of the first and second pulses from the respective first and second electrodes in opposite directions along the nerve tissue, the switch control signal generated by the control module changes an operating mode of the bipolar stimulation probe,
wherein: in a first mode of operation of the bipolar stimulation probe, (i) the first switch is in a first state and the first pulse is delivered to the first electrode through the first switch, and (ii) the second switch is in a first state and receives return current from the patient; and in a second mode of operation of the bipolar stimulation probe, (i) the second switch is in a second state and the second pulse is delivered to the second electrode through the second switch, and (ii) the first switch is in a second state and receives return current from the patient,
the first and second pulses are supplied from a single power source,
the stimulation module is configured to cause each of the first and second electrodes to alternate between operation as a cathode and operation as an anode, wherein the first and second pulses are both positive or both negative.
The Patent also recites “a control module configured to stimulate a nerve tissue of a patient based on recalled parameters“ but not expressly disclose a memory housed in the housing and configured to store one or more stimulation parameters.
Thrope et al teach an analogous bipolar stimulation probe comprising a memory housed in the housing and configured to store one or more stimulation parameters, the memory necessarily found in on-board, programmable microprocessor –
“control circuitry 28 desirably includes an on-board, programmable microprocessor, which carries embedded code. The code expresses pre-programmed rules or algorithms for generating the desired electrical stimulation waveforms… [e.g.] stimulus frequency is 20 Hz, (although the frequency may be adjustable, e.g., 3 Hz to 100 Hz), and the waveform comprises a charge balanced biphasic waveform (i.e., no net DC current flow)” (0032),
“electrical stimulation control circuitry 28 is carried within the handle 16 (see FIGS. 2A and 2B)” (0031);
a stimulation module 28 configured to stimulate nerve tissue of a patient by generating a first and a second pulse to be output from at least the first electrode – “control circuitry 28 generates a stimulation current which is applied through the contacts 22 and 24” (0031),
the first pulse and the second pulse being generated based on the one or more stimulation parameters recalled from the memory – “The code expresses pre-programmed rules or algorithms for generating the desired electrical stimulation waveforms” (0032).
Thus, Thrope et al specify the memory that enables recall of the parameters recited by the Patent. Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the Patent such that it includes a memory housed in the housing and configured to store one or more stimulation parameters such that the first pulse and the second pulse are generated based on the one or more stimulation parameters recalled from the memory as taught by Thrope et al to effectively provide the electrical and processing structure for the recall of the stimulation parameters during use of the device of the Patent.
Response to Arguments
Applicant's arguments filed have been fully considered but they are not persuasive. Applicant contends that the prior art does not disclose a bipolar stimulation probe having a memory housed in the housing with the first and second oppositely directed monophasic pulses are generated based on the one or more stimulation parameters recalled from the memory and each being a selected one of positive or negative (Remarks pg. 8).
However, it is noted that Thrope et al teach the structure of the bipolar stimulation probe including a memory housed in the housing and configured to store one or more stimulation parameters, the memory necessarily found in on-board, programmable microprocessor –
“control circuitry 28 desirably includes an on-board, programmable microprocessor, which carries embedded code. The code expresses pre-programmed rules or algorithms for generating the desired electrical stimulation waveforms… [e.g.] stimulus frequency is 20 Hz, (although the frequency may be adjustable, e.g., 3 Hz to 100 Hz), and the waveform comprises a charge balanced biphasic waveform (i.e., no net DC current flow)” (0032),
“electrical stimulation control circuitry 28 is carried within the handle 16 (see FIGS. 2A and 2B)” (0031);
a stimulation module 28 configured to stimulate nerve tissue of a patient by generating a first and a second pulse to be output from at least the first electrode – “control circuitry 28 generates a stimulation current which is applied through the contacts 22 and 24” (0031),
the first pulse and the second pulse being generated based on the one or more stimulation parameters recalled from the memory – “The code expresses pre-programmed rules or algorithms for generating the desired electrical stimulation waveforms” (0032).
Davis et al is used to teach the generation of the first and second oppositely directed as elaborated above and Hacker et al teach the pulses as monophasic as well as each being a selected one of positive or negative – “the stimulator may alternatively be activated to deliver a complete cycle of monophasic electrical stimulation comprising a selected number of pulses that are all positive phase or all negative phase… The intraoperative neural monitoring system may also include a patient interface unit electrically connectible with the power source for delivering electrical stimulation to the patient via a monopolar or bipolar stimulating probe” (Col.5: 42-65 of Hacker et al). It is noted that Hacker et al was previously used to teach all the pulses as positive or negative in claims 28 and 36 and that this has not been addressed by applicant.
While applicant contends that Davis et al do not disclose operation of first and second electrodes of a bipolar stimulation probe (Remarks pg. 8), a skilled artisan would recognize the advantage of providing oppositely directed pulses as claimed and be able to modify said electrical circuitry with memory and control module already taught by Thrope et al with said functionality as applicant has not provided any reason why this is not possible or nonobvious. Therefore, the rejection is maintained.
The previous double patenting rejection is updated in the manner above.
Regarding the 112(f) interpretation, applicant contends that elements are “names for structural electronic components and are further defined by their recited connections and operations” (Remarks pg. 7). It is noted the limitations as recited of stimulation module, control module, and feedback module do not convey any structure at all let alone electronic component structure as “a module” does not denote any known structure in the art. For example, a module may be hardware, software, or a combination, thus providing variability in its interpretation. “Module” is thus a nonce term coupled with the functions of stimulation, control, and feedback, respectively. Therefore, the 112(f) interpretation is appropriate.
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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/H.Q.N/Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791
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