DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Objections
Claims 20, 21, and 23-28 are objected to because of the following informalities:
Claim 20 recites “such that electrosurgical signals” in line 19, which should recite “such that the electrosurgical signals” in order to provide proper antecedence.
Claim 27 recites “wherein electrosurgical signals” in line 15, which should recite “wherein the electrosurgical signals” in order to provide proper antecedence.
Appropriate correction is required.
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 9, 10,12-21 and 23-28 are rejected on the grounds of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 11,950,832. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of U.S. Patent No. 11,950,832 anticipate the claims of the application. Accordingly, the application claims are not patentably distinct from the patent claims. Here, the more specific patent claims encompass the broader application claims. Following the rationale in In re Goodman cited in the preceding paragraph, where applicant has once been granted a patent containing a claim for the specific narrow invention, applicant may not obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
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 9, 10, 12-21 and 23-28 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 9 recites “a monitoring input configured to receive a monitoring signal indicative of electromyographic (EMG) activity from a nerve monitoring system” in lines 9-10 and “a selection module coupled to … the monitoring input… wherein the selection module is further configured, in response to the monitoring signal, to disconnect the instrument from the electrosurgical generator such that electrosurgical signals are prevented from being delivered to the instrument” in lines 11-19 which is 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. The current application teaches sensing probes that provide signals to the interface module and then the interface module can disable any further signals from ESU as described in paragraph 0023, however there is no disclosure for a monitoring input as claimed.
Claim 20 recites “a monitoring input configured to receive a monitoring signal indicative of electromyographic (EMG) activity associated with proximity between the instrument and a nerve” in lines 8-10 and “a selection module coupled to … the monitoring input” in lines 11-12, which is 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. The current application teaches sensing probes that provide signals to the interface module and then the interface module can disable any further signals from ESU as described in paragraph 0023, however there is no disclosure for a monitoring input as claimed.
Claim 27 recites “a monitoring input configured to receive a monitoring signal indicative of electromyographic (EMG) activity associated with proximity between an instrument and a nerve” in lines 7-8 and “a selection module coupled to… the monitoring input” in line 11, which is 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. The current application teaches sensing probes that provide signals to the interface module and then the interface module can disable any further signals from ESU as described in paragraph 0023, however there is no disclosure for a monitoring input as claimed.
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 18, 19 and 26 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 18 recites the limitation "a first circuit" in line 3 and “a second circuit” in line 5 of the claim. There is insufficient antecedent basis for this limitation in the claim in light of the recitation of “a circuit” in line 15 of claim nine. It is not if or how these circuits are related.
Claim 19 recites the limitation "the interface module is configured to disable the second circuit to prevent the electrosurgical signal from being sent to the instrument” in lines 1-3 of the claim. There is insufficient antecedent basis for this limitation in the claim in light of the recitation of “wherein the selection module is further configured, in response to the monitoring signal, to disconnect the instrument from the electrosurgical generator such that electrosurgical signals are prevented from being delivered to the instrument” in lines 16-19 of claim nine. It is not clear if or how these recitations are related.
Claim 26 recites the limitation of “wherein the interface module is configured to disable the second circuit to prevent the electrosurgical signals from being sent to the instrument” in lines 1-3 of the claim. There is insufficient antecedent basis for this limitation in the claim in light of the recitation of “wherein the selection module is further configured, in response to the monitoring signal, to disable the second circuit such that electrosurgical signals are prevented from being delivered to the instrument” in lines 17-19 of claim twenty. It is not clear what element is performing this recitation and/or if these limitations are supposed to be different in some way.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 9, 10, 12, 14, 16-21 and 23-28 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Utley et al (6,139,545) in view of McFarlin et al (2007/0100336).
Referring to claims 9, 20, 23, 27 and 28, Utley et al teaches an interface module (42) for use with an electrical stimulation generator (52), the interface module comprising: a first input configured to receive electrical stimulation signals from an electrical stimulation generator (Col. 6, lines 36-53; Figure 3); a second input configured to receive electrosurgical signals from an electrosurgical generator (40) (Col. 6, lines 53-65; Figure 3); an output (via 70) configured to deliver output signals to an instrument configured for at least one of nerve stimulation or electrosurgery (Col. 6, line 66 through Col. 7, line 4; Figure 3); and a selection module (front panel of 42 including 44, 46, 56 and 58) coupled to the first input, the second input, and the output, wherein the selection module is configured to select one of the electrical stimulation signals or the electrosurgical signals as output signals and deliver the output signals to the output (Col. 8, lines 48-53; Figures 3-5). Utley et al teaches wherein electrosurgical signals from the electrosurgical generator (40) are transmitted to the instrument via a circuit including the electrosurgical generator, the second input, the selection module (front panel of 42 including 44, 46, 56 and 58), the output (via 70), and the instrument (Col. 7, lines 5-30; Col. 8, line 47 through Col. 9, line 3; Figure 3). Utley et al teaches the selection module being further configured to define a first circuit including the electrical stimulation generator (52), the interface module, and the instrument and a second circuit including the electrosurgical generator (40), the interface module, and the instrument (28) (Col. 7, lines 5-30; Col. 8, line 47 through Col. 9, line 3; Figure 3). Utley et al teaches a selection module coupled to the first and second inputs and the output, the selection module being configured, in a stimulation mode, to couple the first input to the output to route the electrical stimulation signals to the instrument, and, in an electrosurgical mode, to couple the second input to the output to route the electrosurgical signals to the instrument, wherein electrosurgical signals from the electrosurgical generator are transmitted to the instrument via a circuit including the electrosurgical generator, the second input, the selection module, the output, and the instrument (Col. 7, lines 5-30; Col. 8, line 47 through Col. 9, line 3; Figures 3-5).
Utley et al fails to teach a monitoring input configured to receive a monitoring signal indicative of electromyographic (EMG) activity associated with proximity between an instrument and a nerve. McFarlin et al teaches an analogous interface module comprising a monitoring input (356) configured to receive a monitoring signal (via EMG electrodes 364 and 366) indicative of electromyographic (EMG) activity associated with proximity between an instrument and a nerve wherein the monitoring signal is fed back to disconnect the instrument (352) to prevent signal from being delivered to the instrument (paragraph 0070; Figure 7). It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the interface module, as taught by Utley et al, to include a monitoring input configured to receive a monitoring signal indicative of EMG activity associated with proximity between the instrument and a nerve, as taught by McFarlin et al, in order to detect critical anatomy (paragraph 0070).
Furthermore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the selection module, as taught by Utley et al, to disconnect the instrument to prevent signals from being delivered to the instrument in response to monitoring signals, as taught by McFarlin et al, in order to ensure patient safety (paragraph 0070).
Referring to claims 10 and 21, Utley et al teaches wherein the selection module (front panel of 42 including 44, 46, 56 and 58) continuously interleaves the electrical stimulation signals and the electrosurgical signals in the output signals (Col. 8, lines 48-60; Figures 3-5). The selection module is capable of being toggled between the electrical stimulation mode and the electrosurgical mode. This is 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.
Referring to claim 12, Utley et al teaches wherein the selection module (front panel of 42 including 44, 46, 56 and 58) is an electrical network (Col. 8, lines 48-60; Figures 3-5).
Referring to claim 14, Utley et al teaches wherein the selection module (front panel of 42 including 44, 46, 56 and 58) is a mechanical switch (Col. 8, lines 48-60; Figures 3-5).
Referring to claim 16, Utley et al teaches wherein the electrosurgical signals are radio frequency (RF) signals (Col. 6, lines 53-61).
Referring to claims 17 and 24, Utley et al teaches wherein the selection module (front panel of 42 including 44, 46, 56 and 58) is configured to disconnect an electrical circuit including the instrument (28), the electrosurgical generator (40), and the interface module (42) (Col. 7, lines 5-30; Col. 8, line 47 through Col. 9, line 3; Figure 3).
Referring to claims 18 and 25, Utley et al teaches wherein the selection module (front panel of 42 including 44, 46, 56 and 58) is configured to: complete a first circuit including the instrument (28), the electrical stimulation generator (52), and the interface module (42); and selectively complete a second circuit including the instrument (28), the electrosurgical generator (40), and the interface module (42) (Col. 7, lines 5-30; Col. 8, line 47 through Col. 9, line 3; Figure 3).
Referring to claims 19 and 26, Utley et al teaches wherein the interface module is configured to disable the second circuit to prevent the electrosurgical signals from being sent to the instrument (Col. 7, lines 5-30; Col. 8, line 47 through Col. 9, line 3; Figure 3).
Claim 13 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Utley et al (6,139,545) in view of McFarlin et al (2007/0100336) as applied to claim 9 above, and further in view of Steven W. Kovalcheck (2007/0156129).
Referring to claim 13, Utley teaches an electrical stimulation mode and an ablation mode but is silent to an electrosurgical cutting mode, and an electrosurgical coagulation mode. Kovalcheck teaches an analogous interface module that operates in an electrical stimulation mode, an electrosurgical cutting mode, and an electrosurgical coagulation mode (paragraph 0123). It would have been obvious to one of ordinary skill at the time that the invention was made to modify the interface module, as taught by Utley et al, to operate in an electrical stimulation mode, an electrosurgical cutting mode, and an electrosurgical coagulation mode, as taught by Kovalcheck, in order to achieve different functional results (paragraph 0123).
Claim 15 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Utley et al (6,139,545) in view of McFarlin et al (2007/0100336) as applied to claim 9 above, and further in view of Joe D. Sartor (2009/0024120).
Referring to claim 15, Utley et al teaches wherein the selection module is a switch, however fails to expressly teach an electrical switch. Sartor teaches an analogous interface module comprising a selection module is an electrical switch (paragraph 0034). It would have been obvious to one of ordinary skill at the time that the invention was made to modify the switch, as taught by Utley et al, to be an electrical switch, as taught by Sartor, because this is a simple substitution of one known element for another to obtain predictable results (See MPEP 2143). Sartor teaches that a various switch types are well known in the art (paragraph 0034).
Response to Arguments
Applicant’s arguments with respect to the pending claims have been considered but are moot in view of the new ground(s) of rejection.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMANTHA M GOOD whose telephone number is (571)270-7480. The examiner can normally be reached Mon to Wed, 7am to 3pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Linda Dvorak can be reached at 571-272-4764. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SAMANTHA M GOOD/Examiner, Art Unit 3794
/MICHAEL F PEFFLEY/Primary Examiner, Art Unit 3794
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