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.
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 08 December 2025 is acknowledged.
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 3-6 and 15 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.
Regarding claims 3-6, claim 3 recites a plurality of sensors. It is not clear what the relationship is between these sensors and the sensor recited in claim 1. Claims 4-6 depend from claim 3 and are therefore also indefinite.
Regarding claim 5, aside from the fact that the energy source is not positively recited as discussed below, it is not clear what characteristics the energy source has when operating in “back scoring” or “poke and spread” treatment types. These include methods of using the instrument itself and there is no clear relationship between those types and energy output parameters. In theory, an operator could “poke and spread” while the instrument is in any configuration.
Regarding claim 15, there is no antecedent basis for “the electrosurgical energy source.” At best, it is not clear if this “electrosurgical energy source” is the same as the generator previously recited.
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 2 and 4-6 are 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 features of the electrosurgical energy source which is not positively recited in claim 1. What features a hypothetical energy source may have does not change the structure of the instrument. 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 § 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.
Claims 1, 2 and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jensen (US 2015/0088122).
Regarding claims 1 and 2, Jensen discloses a surgical instrument with two jaws (110, 120, fig. 1) attached to an elongated shaft (12) attached to a housing (20). The jaws further include sealing plates (114, 124) where sensors are disposed “on” the sealing plates (126, 128, [0039]). The sensors are configured to communicate data relating to a location of tissue disposed between the jaw members (“tissue presence sensors,” [0039]). The claims also recite a hypothetical “electrosurgical energy source” that is functionally related to the sealing plates and sensors. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited in the preamble, or elsewhere in a claim, then it meets the claim. In this case, since there exists a hypothetical “electrosurgical energy source” that could perform any number of functions using the collected data if connected to the instrument of Jenson, including adjusting energy parameters applied to the sealing plates, the surgical instrument of Jenson anticipates the claims. However, in the interest of compact prosecution, see the conclusion below for references that are relevant to the hypothetical electrosurgical energy source.
Regarding claim 15, in addition to the features discussed above, Jenson further discloses that instrument is part of a system that includes a generator for outputting electrosurgical energy (“G,” fig. 1). Further, the generator uses the location data to adjust one or more parameters associated with the energy delivery (see discussion associated with fig. 10, where whether energy is applied or not, and thus whether power, current, voltage, duration or pulse width are non-zero values, is a function of the measured presence of tissue).
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.
Claims 3-6 are rejected under 35 U.S.C. 103 as being unpatentable over Jenson in view of Worrell (US 2016/0287316).
Regarding claim 3, Jenson does not specifically disclose there are at least three longitudinally spaced sensors for determining tissue location data at proximal, middle and distal locations along the jaw. However, Jenson does disclose that using the sensors to detect not just tissue presence between the jaws but the position of tissue between the jaws which would require multiple sensors by definition ([0039]). Worrell discloses a surgical instrument with a plurality of sensors (168’, fig. 4C) placed longitudinally along a jaw to create at least proximal, middle and distal regions for identification of tissue contact for the purposes of controlling energy output (see discussion associated with figs 5b-e, see also [0075]). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to modify the instrument of Jenson to include a plurality of sensors including at least proximal, middle and distal sensors as taught by Worrell, that would produce the predictable result of allowing tissue presence information to be generated at those locations for control purposes.
Regarding claims 4-6, these claims, as discussed above, recite features of an electrosurgical energy source that is not claimed. Since there exists a hypothetical electrosurgical energy source that uses the tissue location data in the claimed manner, the instrument of Jenson as modified renders the claims unpatentable. However, in the interest of compact prosecution, see the conclusion below for references that are relevant to the hypothetical electrosurgical energy source.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Regarding the use of a plurality of sensors set in a longitudinal direction along the inner facing surface of jaws, see fig. 5B of US 2011/0270252 to Horner. Regarding a forceps device with a plurality of sensors creating three longitudinal zones of control, see US 2015/0223867 to Brandt, which notes that the sensors can be pressure sensors ([0034]) which would be indicative of the presence of tissue in a way that temperature sensors might not. Regarding the use of sensors within forceps jaws to determine tissue type, which would by definition be a measure of tissue location, see paragraph [0059] of US 2010/0036379 to Prakash. Regarding a forceps that has proximal, middle, and distal regions controlled by tissue presence sensors, see discussion associated with figures 119-121 of US 2017/0238991 to Worrell (see also figs. 122-124 and 131-133). Regarding the use of bipolar pairs to determine where tissue is located along jaws, see discussion associated with figures 93-96 of US 2019/0201046 to Shelton. Regarding the use of sensed information to control bipolar/monopolar modes of operation, see paragraph [0016] of US 2020/0315689 to Schneider and paragraph [0010] of US 2013/0178852 to Allen.
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/DANIEL W FOWLER/Primary Examiner, Art Unit 3794