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.
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 22-24 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 22 and 23, the preamble of the claims state that the invention is a thermal cutting element “of” an electrosurgical instrument and the details of claim 1 are entirely directed to the thermal cutting element. But claim 22 recites a feature of the instrument so that it is unclear if the claims are directed to a thermal cutting element or an instrument that includes a thermal cutting element. Claim 23 depends on claim 22 and is therefore also indefinite.
Regarding claim 24, the claim is worded in a manner that renders the claim indefinite. The claim is directed to a thermal cutting element which comprises, among other things, a base substrate. But the claim recites that the cutting surface is defined by the thermal cutting element extending between sides of the base substrate. This makes it unclear what the relationship is between the thermal cutting element and the base substrate. The thermal cutting element cannot both include a base substrate and yet extend between sides of the base substrate. The issue is not helped by the fact that the claim continues to recite the heater circuit trace being located on the insulator located on one side of the substrate, limitations that already exist in claim 1.
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 1-9 and 22-24 are rejected under 35 U.S.C. 103 as being unpatentable over Lau (US 2006/0217706) in view of Eggers (US 2016/0242836) and Horlle (US 2014/0228844).
Regarding claims 1-5, 22 and 23, Lau discloses what can be considered a generic electrosurgical instrument that employs a thermal cutting element in a slot that protrudes from a tissue treating surface (fig. 16A-B). Lau does not disclose the particulars of the resistively heating cutting element because such elements are ubiquitous and well within the level of ordinary skill in the art to construct. Eggers, for example, discloses a thermal cutting element (e.g. fig. 18) with a base substrate (170) provided with an insulating layer (160) provided with a heater circuit trace (162). The thermal cutting element has an operating temperature between 70-600°C (T1 and T2 in [0091], note [0090] and see also e.g. [0054]) and a TCR of over 3000 ppm/°C (copper, silver and nickel all having a TCR over that value, [0010]). Eggers does not disclose the use of a body and extension where the trace loops along the body and has ends at the extension. However, this is a common configuration for resistive heaters such as shown by Horlle (fig. 2). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to provide the device of Lau with any commonly known type of resistive heating element, using a substrate, insulating layer and resistive material such as taught by Eggers, arranged in any commonly known configuration, including the heating element extending from an extension and looping at the end of a base as taught by Horlle, that would produce the predictable result of allowing a user to treat tissue in a desired manner.
Regarding claims 6 and 7, the claims are being interpreted as extremely broad rather than indefinite. The first issue is the fact that “room temperature” is variable and the claimed “operating temperature” is 350°C to infinity °C. The second issue is that the claims do not recite any details about the parameters of the electrical energy applied to a material to produce this result. The third issue is that the materials disclosed by Eggers have inherent properties such as a positive temperature coefficient. Therefore, the position is taken that Eggers, within the breadth of temperature ranges and the undefined electrical parameters, discloses materials having a positive temperature coefficient that are capable of having a resistance change in the range of 20-400 ohms between some value in those ranges. It is noted that on top of those issues is the fact that Applicant has not described how to actually make such a thermal cutting element, that is, the specific materials, dimensions or other parameters that would result in these values. Instead, Applicant merely suggests that such a thing is possible (e.g. “The present disclosure also specifically contemplates any and all combinations of these values and/or ranges as well as any and all ratios and/or ratio ranges of the values and/or ranges of two or more of these operating parameters”). For the time being an enablement rejection is not made and instead Applicant is understood to rely on a level of ordinary skill in the art that includes knowledge of how to make and use elements as common as resistive heaters.
Regarding claims 8 and 9, the claims only recite a heating element, not a generator, such that the limitations are very broad considering the scope of the limitations recited in claim 1 (as noted above). Further, the claims do not recite any other structural elements that would necessarily result in a device that would reach a temperature between 350°C and infinity °C using a material with a TCR of 50 ppm/°C to infinity ppm/°C, nor any other parameters of the energy (shape, frequency, power, duration, etc.) that must be applied in addition to the voltage range, to produce the claimed result in tissue. Since the device of Lau as modified could be supplied with a signal at least having a voltage in the claimed range to produce a temperature in the treatment range, Eggers reads on the claims.
Reading claim 24, while the boundaries of the claim are unclear, Lau as modified (with Eggers particularly in view) does show that there is a cutting surface extending between two sides of the base substrate (note edge 180 in fig. 18 of Eggers), where the heater circuit trace is on the insulator which is on the substrate (also shown in figs. 17-18).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Lau, Eggers and Horlle, further in view of Eggers (US 2009/0112200), hereinafter Eggers2.
Regarding claim 10, Lau does not disclose the use of an encapsulating layer. However, encapsulating layers are common in the art and there is no evidence that use here produces an unexpected result (within the meaning of MPEP 716.02(a)). Eggers2 discloses another thermal cutting element with an encapsulating layer (162, fig. 6). Therefore, before the application was filed, it would have been obvious to modify the thermal cutting element to include an encapsulating layer such as taught by Eggers2 to produce the predictable result of a thermal cutting element with desired electrical, thermal and/or mechanical properties.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Lau, Eggers and Horlle, further in view of Beard (US 4,640,279).
Regarding claim 21, Lau does not disclose the use of clips connected to the heater trace circuit. However, clips are commonly used to allow electrical elements to be disconnected. Beard, for example, discloses an instrument with a resistive cutting element and teaches that clips can be used to allow the cutting element to be disposable (see discussion associated with figs. 13-15). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to provide the thermal cutting element of Lau with clips as taught by Beard that would produce the predictable result of allowing the cutting element to be detached from the clips.
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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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/DANIEL W FOWLER/Primary Examiner, Art Unit 3794