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.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the first and second poles being “disposed entirely within the interior cavity” (claims 1 and 6, see Conclusion below for further discussion) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 1-11 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. The claims have been amended to recite that both poles are “entirely within” an interior cavity. The specification does not use the phrase “entirely within,” figure 3 fails to show any poles within the housing, and figures 1 and 2 explicitly show that the poles are not “entirely within” the housing.
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 1-11 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 1-11, the independent claims recite two “poles” that are “disposed entirely within” an interior cavity of a housing. Applicant’s use of those words appears to deviate so far from standard usage that the structural limitations required by the words are unclear. To describe a first element as being “entirely within” a second element requires that the boundaries of the second element entirely encompass the first element. But Applicant’s figures clearly show that that the housing 1oo does not entirely encompass either pole 400 (which extends radially from the external wall of 100, fig. 1) or poll 200 (which extends distally from the external wall of 100, fig. 1). Further, while the specification unhelpfully notes that the poles are “inside” the housing, the specification also contradicts the claim language. Beginning in line 18 on page 6, for example, the specification notes that the pole is “disposed inside the housing and proximal to a first end of the housing.” Aside from the fact that “proximal” should be “distal” based on the figures (e.g. fig. 2), clearly a pole cannot be “entirely within” a housing and be distal (or proximal) to the housing. The only reasonable alternative that suggests itself is that Applicant means that the housing merely comprises both electrodes, as in, the housing is defined by a tube and both electrodes. But even in that possible scenario it remains unclear what the relationship is between the interior cavity of the housing and the poles since the interior cavity is not shown while the poles are, thus refuting any suggestion that the later are within the former. Further, it becomes unclear what the medical device as recited in the preamble actually is relative to the housing and poles. That is, it might be more reasonable to say that the poles are “entirely within” the medical device, although it is unclear in what scenario that would not be the case. It is redundant to say that an object contains all the parts of the object. It is hypothetically possible that this claim language is simply intended to capture the fact that the probe is a bipolar probe and not a monopolar probe in which case the language is the most unclear expression of that structure the examiner has ever encountered. Bipolar probes are extremely common in the tissue treatment art and that structure is reasonably recited by simply saying that one housing/catheter/needle/probe has at least two electrodes for applying different polarities to tissue, or that one is proximal to the other, or any number of other limitations that clearly recite two, adjacent probes for applying bipolar energy. Monopolar systems cannot be arranged in that manner. Occasionally, indefiniteness rejections must be made where a reasonable interpretation of the language can be assumed (e.g. lack of antecedent basis). That is not the case here. The claim language when considered in view of the figures and specification is so unclear (and occasionally contradictory) that a reasonable guess cannot be made as to what structural features are required. The rejections below are based on figure 2.
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 1-5 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Behzadian (US 2006/0074413).
Regarding claims 1-5, Behzadian discloses a medical device (fig. 1) that includes a housing (14, fig. 2A) with an internal cavity (e.g. fig. 4B) having at least three “poles” (10, [0031]) spaced from each other along the housing and independently connected by leads within the housing to an RF generator (2) to allow any combination of polarities to be applied to the “poles” in various bipolar configurations (figs. 3A-C). The center “pole” can be considered an “isolation plate” since it can redirect energy (figs 3A and C) and is electrically isolated from the other two “poles” by the gaps between the poles. Alternatively, either of the two insulating portions between the three poles can be considered an “isolation plate” which electrically isolates the poles and causes energy to be transmitted through adjacent tissue by virtue of not creating an electrical short between the poles. Bipolar probes, by definition, do not require external or transcutaneous return electrodes. Behzadian further teaches that the device is provided with a thermostat (34, [0049], fig. 4B) which operates by outputting a plurality of indication signals each representative of a different temperature range (since all temperature sensors have some margin of error). The language in the claim directed to how the device can be used is a functional limitation. 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.
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 6-11 are rejected under 35 U.S.C. 103 as being unpatentable over Behzadian in view of Moss (US 2013/0090646) and Juergens (US 2014/0276659).
Regarding claims 6-11, the device of Behzadian does not disclose the particulars of the RF generator. However, RF generators are common in the art and commonly useful to output a wide range of parameters. Moss discloses a medical device similar to Behzadian and teaches that the system including device and generator can be used to treat many different conditions in many different anatomical locations ([0097]), and further teaches the use of pulse durations about 100 microseconds ([0104]). Moss does not disclose the particular feedback temperatures, but these temperatures are also commonly known in the art such as taught by Juergens ([0035]). Therefore, before the application was filed, it would have been obvious to modify the device of Behzadian to include a generator outputting parameters known to be useful for a wide range of treatment types such as taught by Moss, including using pulses having the duration taught by Moss and the temperature control taught by Juergens, that would produce the predictable result of allowing a user to interact with tissue in a desired manner. While it is noted that Moss expressly contemplates collagen rich tissue and skin as treatment locations ([0097]), and Juergens also is a collagen-shrinking system ([0028]), 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.
Response to Arguments
Applicant's arguments filed 03 November 2025 have been fully considered but they are not persuasive.
Regarding the drawing objection, Applicant makes flat assertions without evidence or augment (e.g. no figure or paragraph is cited) that do not address the fundamental problem that the structural relationships of the device are not clear. Applicant states that “the poles are shown positioned within the housing” which is flatly untrue. Figures 1 and 2 not only fail to show any internal cavity but clearly show the electrodes are not “entirely within” the housing, being either raised above or extending from the housing. Figure 3 is the only figure that even purports to show the internal cavity of the housing and but does not show any poles at all, and further fails to show any wiring or other elements that would allow the poles to be functional. It is not clear whether the core problem leading to the objection is with the drawings for failing to show the invention or with the specification for failing to clearly describe the features of the invention shown in the figures by using language consistent with common usage or at least provided with explicit definitions of terms that deviate from common usage.
Regarding the indefiniteness rejection, the arguments are not persuasive for substantially the same reasons discussed above. Applicant cites no figures or paragraphs for support and provides very little elaboration to address the fundamental problem that it is not clear what structure this invention has because the figures and language of the specification are inconsistent with each other and with common usage of words like “entirely” and “within.” There is a passing remark that the claim language “distinguishes the claimed configuration from systems in which electrodes are externally exposed or rely on transcutaneous return paths.” It is difficult to parse this remark since 2/3rds of the figures explicitly show externally exposed electrodes.
While the rejections have changed in view of the amendments, it is noted that several of the arguments are not persuasive even when considered in view of the new limitations. As discussed at length above, some invention where the electrodes are entirely within the housing such that no conductive element is exposed to an external environment is simply not contemplated in any reasonable way by this application. The drawings, one of which is annotated below, show the exact opposite, and the specification does not provide sufficient detail to arrive at that conclusion.
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Further, Applicant appears to conflate “lack of external electrode” with an electrode that does not contact tissue. But those are not the same concept. As Applicant notes in the background of the invention, monopolar devices use external return electrodes while bipolar devices use local return electrodes. While capacitive coupling exists such that an electrode need not touch tissue directly (e.g. when a non-stick coating is used), there is no necessary relationship between a return electrode and contacting tissue. The arguments could be read as insinuating that Applicant has invented bipolar probes. This cannot be an accurate assessment of the arguments because bipolar probes are so ubiquitous they have their own classification (A61B2018/126). Even when considered pragmatically, the probe shown by Behzadian is, aside from the extra electrode (which serves exactly the same function as the “plate”), essentially identical with the probe shown by Applicant in figure 2. If what Applicant means is simply that the invention uses bipolar electrodes, it is wholly unclear how Applicant can then argue that Behzadian materially difference since that device also uses bipolar electrodes (note different polarities on the electrodes in the various figures). Further, Applicant makes some statements that are difficult to reconcile with the way bipolar probes operate. For example, on page 9 Applicant states that the current path exists “entirely within the device.” This cannot be true, or else the current would, by definition, not travel through tissue and so no treatment would result from using the device. Or again, “Behzadian fails to disclose… architecture configure to… operate without an external return electrode.” Even a cursory reading of Behzadian shows this to be false: that invention is entirely and only directed to a system that operates without an external return electrode. In fact, Behzadian goes to far as to criticize the use of external return electrodes ([0004], [0006]). Or again, “the thermostat [of Behzadian] merely reports temperature conditions it does not define or modify electrode structure.” First, Applicant’s use of “electrode” here is evidence that using the word “pole” instead is unnecessary. Second, the claims do not say anything about “define or modify electrode structure.” Third, the specification says nothing about “define or modify electrode structure.” Fourth, it is not even clear what that means: how is the structure of the electrode/pole being modified based on temperature? Fifth, Applicant’s specification explicitly notes the temperature can be a thermostat. Sixth, Behzadian does clearly teach that temperature collected by the temperature sensors is used for control purposes ([0049]), assuming that is what Applicant means by “define or modify electrode structure.”
Regarding the isolation plate, it is noted that since the claim language is broad enough to encompass features of Behzadian, rejections other than prior art rejections are not made at this time. However, in a narrower sense, it is completely unclear what the structure of this plate is relative to the electrodes. First, it is unclear why the term “plate” is used since the element is clearly not a plate. Second, if the “plate” is simply grounded, then it is not electrically isolated from ground which commonly forms the other pole of a bipolar pair. The specification is almost completely silent about how the bipolar pair can be in an electrical circuit while the “plate” electrode circuit is somehow completely electrically isolated from either of the bipolar electrodes/poles. Even assuming that somehow the “plate” is grounded independent of both electrodes, then it becomes unclear how the device can be functional since the “plate” will then function just like another negative pole. The specification simply describes that the isolation plate functions as an additional grounding electrode to thus change the current density (“redirect RF energy”) produced between the other two electrodes. This is exactly the same reason that Behzadian uses a conductive element between two other conductive elements (e.g. [0041]). If the claim language becomes more specific without a commensurate explanation, drawing objections and rejections under 35 U.S.C. 112(a) will be forthcoming.
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 DANIEL WAYNE FOWLER whose telephone number is (571)270-3201. The examiner can normally be reached Monday-Friday (9-5).
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/DANIEL W FOWLER/Primary Examiner, Art Unit 3794