DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Specification
The disclosure is objected to because the first paragraph does not provide the most current status for a related application. That is, the parent application is referenced as a U.S. application even though it has issued as a patent. The paragraph should be amended to include the appropriate patent number.
Furthermore, the lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claim 29 is objected to because of the following informalities: it should be noted that there are two different claims that have been identified as ‘claim 29’, but no claims that have been identified as ‘claim 28’. It appears as though the numbering of the first ‘claim 29’ should be amended to read ‘claim 28’. Appropriate correction is required. For the sake of examination, the first ‘claim 29’ will be referred to from this point forward as ‘claim 28’.
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 24, 25, 32, and 33 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.
Claims 24 and 32 recite the limitation “the tissue treatment waveforms are applied to the patient body when the return electrodes are uncoupled from one another”. However, Applicant’s disclosure only describes nerve detection waves being applied to the patient body when the return electrodes are uncoupled from one another. Therefore, it appears as though there is insufficient support in Applicant’s disclosure for the current claim language.
It should be noted that all other cited claims have been rejected for being dependent upon a rejected base claim.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 21-40 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.
Claims 21 (line 6), 29 (line 9), and 37 (line 8) recite the limitation "a nerve". The antecedent basis for this limitation is confusing, since it has already been recited.
Claim 25 recites the limitation "one or more surgical instruments" in lines 2-3. The antecedent basis for this limitation is confusing, since it’s unclear how/whether it’s related to the previously-recited “surgical instrument”.
Claim 37 recites the limitation "a patient body" in line 4. The antecedent basis for this limitation is confusing, since it has already been recited.
It should be noted that all other cited claims have been rejected for being dependent upon a rejected base claim.
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 21-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 12,226,151. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims anticipate the claims of the application. Accordingly, the application claims are not patentably distinct from the patented 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 § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 21-27, 29-35, and 37-40 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bartol, U.S. 2011/0230783 (hereinafter Bartol).
Regarding claim 21, Bartol discloses (note figs. 1 and 5A-F) an electrosurgical system comprising: nerve detection sensors (‘62’ in figs. 5E-F; also note paragraph 33) configured to be spaced different distances (necessarily) from a nerve in a patient body, wherein the nerve detection sensors are necessarily configured to detect nerve detection waveforms applied to the patient body by a surgical instrument (16); and a control circuit (note paragraph 46) configured to analyze respective strengths of output signals from the nerve detection sensors to determine a location of a nerve in the patient body (note paragraph 55).
Regarding claim 22, Bartol discloses (see above) an electrosurgical system further comprising: return electrodes (90a-b/92a-d) capable of receiving tissue treatment waveforms applied to the patient body by the surgical instrument, wherein each of the nerve detection sensors is mounted to a corresponding one of the return electrodes (see fig. 5F).
Regarding claims 23 and 26, Bartol discloses (see above) an electrosurgical system capable of applying the claimed waveforms in the claimed manner.
Regarding claims 24 and 25, Bartol discloses (see above) an electrosurgical system wherein: the tissue treatment waveforms are capable of being applied to the patient body when the return electrodes are uncoupled from one another; the control circuit is necessarily configured to input the location of the nerve into a ‘nerve stimulation algorithm profile’ (note paragraph 59); and the nerve stimulation algorithm profile resides in a memory circuit of a generator (note paragraph 24) coupled to one or more surgical instruments.
Regarding claim 27, Bartol discloses (see above) an electrosurgical system further comprising: an electrosurgical pad (56) configured to be capacitively coupled to the patient body, wherein the electrosurgical pad includes the nerve detection sensors.
Regarding claim 29, Bartol discloses (note figs. 1 and 5A-F) an electrosurgical system comprising: a generator (necessarily – note paragraph 25) configured to generate waveform signals; a surgical instrument (16) configured to supply electrosurgical energy from the generator to a patient body; nerve detection sensors (‘62’ in figs. 5E-F; also note paragraph 33) configured to be spaced different distances (necessarily) from a nerve in the patient body, wherein the nerve detection sensors are necessarily configured to detect nerve detection waveforms applied to the patient body by the surgical instrument; and a control circuit (note paragraph 46) configured to analyze respective strengths of output signals from the nerve detection sensors to determine a location of a nerve in the patient body (note paragraph 55).
Regarding claim 30, Bartol discloses (see above) an electrosurgical system further comprising: return electrodes (90a-b/92a-d) capable of receiving tissue treatment waveforms applied to the patient body by the surgical instrument, wherein each of the nerve detection sensors is mounted to a corresponding one of the return electrodes (see fig. 5F).
Regarding claims 31 and 34, Bartol discloses (see above) an electrosurgical system capable of applying the claimed waveforms in the claimed manner.
Regarding claims 32 and 33, Bartol discloses (see above) an electrosurgical system wherein: the tissue treatment waveforms are capable of being applied to the patient body when the return electrodes are uncoupled from one another; the control circuit is necessarily configured to input the location of the nerve into a ‘nerve stimulation algorithm profile’ (note paragraph 59); and the nerve stimulation algorithm profile resides in a memory circuit of the generator (note paragraph 24).
Regarding claim 35, Bartol discloses (see above) an electrosurgical system further comprising: an electrosurgical pad (56) configured to be capacitively coupled to the patient body, wherein the electrosurgical pad includes the nerve detection sensors.
Regarding claim 37, Bartol discloses (note figs. 1 and 5A-F) an electrosurgical pad (56) comprising: nerve detection sensors (‘62’ in figs. 5E-F; also note paragraph 33) configured to be spaced different distances (necessarily) from a nerve in a patient body, wherein the nerve detection sensors are necessarily configured to detect nerve detection waveforms applied to the patient body by a surgical instrument (16), and wherein respective strengths of output signals from the nerve detection sensors are indicative of a location of a nerve in the patient body along the electrosurgical pad (note paragraphs 46 and 55).
Regarding claim 38, Bartol discloses (see above) an electrosurgical pad further comprising: return electrodes (90a-b/92a-d) capable of receiving tissue treatment waveforms applied to the patient body by the surgical instrument, wherein each of the nerve detection sensors is mounted to a corresponding one of the return electrodes (see fig. 5F).
Regarding claims 39 and 40, Bartol discloses (see above) an electrosurgical pad wherein the waveforms are capable of being applied in the claimed manner.
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.
Claim(s) 28 and 36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bartol in view of Wasserman, U.S. 2018/0050200 (hereinafter Wasserman).
Regarding claims 28 and 36, Bartol discloses (see above) an electrosurgical system comprising a single control circuit configured to analyze output signals from a plurality of nerve detection sensors (note fig. 1). However, Bartol fails to explicitly disclose that the control circuit is configured to: provide selection signals to a multiple input - single output switching device (even though the signal path between the nerve detection sensors and the control circuit contains multiple inputs and a single output); and set the selection signals to control the multiple input - single output switching device to output only one of the output signals for analysis. Wasserman teaches (note fig. 3) a relevant system comprising a control circuit configured to: provide selection signals to a ‘multiple input - single output switching device’ (multiplexer); and set the selection signals to control the multiple input - single output switching device to output only one of the output signals (at a time) for analysis (note paragraph 7). It is well known in the art that the use of this switching device configuration, along with the sequential data analysis that it enables, would result in increased safety and efficiency. Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed, to have modified the electrosurgical system of Bartol to comprise a control circuit configured to: provide selection signals to a multiple input - single output switching device; and set the selection signals to control the multiple input - single output switching device to output only one of the output signals for analysis. This is because this modification would enhance data analysis, thereby resulting in increased safety and efficiency.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
U.S. 2015/0238260 (Nau).
U.S. 2017/0000549 (Gilbert).
U.S. 2017/0215758 (Schepis).
U.S. 2016/0081744 (Wang).
U.S. 2020/0038096 (Schepis).
U.S. 9,084,550 (Bartol).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THOMAS ANTHONY GIULIANI whose telephone number is (571)270-3202. The examiner can normally be reached Mon - Fri 9:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Rodden can be reached at 303-297-4276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/THOMAS A GIULIANI/Primary Examiner, Art Unit 3794
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