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 “structurally disposed inside said housing” (claims 1, 8 and 14), an isolation plate capable of redirecting energy (claims 13 and 19), a sensor that comprises a controller (claims 20 and 21) and a sensor that is capable of both monitoring and tracking a plurality of 1cm treatment sectors (claims 24-25) 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 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 1-25 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 1-25, the independent claims recite two “poles” that are “structurally disposed inside said housing.” It is not clear in what sense Applicant is using the word “pole,” nor in what sense these elements are “inside said housing.” The word “pole” can generally mean a long cylindrical object, which would not apply to the first pole which is only shown as being a dome, no part of which is “inside said housing.” Further, the second pole appears to be located entirely outside the housing (fig. 1). Figure 2 appears to show each pole and the “plate” (which is not flat at all) entirely distal to the housing. Figure 3, which appears to be a cross-section of the housing, does not show either pole being “structurally disposed inside said housing” and yet shows the “plate” being entirely within the housing, flatly contradicting figures 1 and 2. Even assuming both electrodes somehow are long cylindrical objects, that would make it unclear what the relationship is between the two “poles” and the housing, which is also a pole at least in the general sense. In this technology “pole” is also used to describe electrical polarity, so it may be that Applicant is stating that there are two electrical poles within the housing. But the claims do not recite that there are conductive elements configured to be supplied with electrical polarity “inside said housing” and signals per se are not patent eligible subject matter (35 U.S.C. 101, MPEP 2106.03) so this interpretation seems unlikely. For the purpose of examination, the first and second “poles” will be treated as electrodes having electrical connections within the housing. The dependent claims depend from one of the independent claims and are therefore also indefinite.
Regarding claims 11 and 17, it is entirely unclear how the “plate” can “redirect” energy. The specification is silent on the electrical connections of the “plate,” whatever electrical controller is involved, or even generally on the manner in which energy between a bipolar pair can be “redirected.” The fact that energy flows between the “poles” makes it unclear exactly what the plate is doing. This is being treated as an indefiniteness issue but it is possible that a rejection under 35 U.S.C. 112(a) for lack of enablement may be forthcoming. It is also noted that the word “undesired” is being interpreted as extremely broad rather than indefinite.
Regarding claims 20-21, the claims recite that a sensor comprises a controller. Sensors and controllers are distinct structural elements with distinct features and functions and it is unclear how a sensor could comprise a controller, or even more generally what structure can be considered both a sensor and a controller. The issue is exacerbated by the fact that the neither the drawings nor the specification discuss the sensor/controller in any detail. Further, “optimal” is a term of degree which renders the claim indefinite. The term “optimal” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is not clear exactly what temperature is “optimal” given the broad range of circumstances that would influence a desired output.
Regarding claims 24-25, the structure required by the claims is unclear. A sensor is an element that collects information and it is unclear how a single position sensor could both determine and track multiple discrete treatment sectors without the aid of a controller for processing the sensed information, particularly treatment sectors measured in increments of 1 square centimeter. Because the structure required by the claims is unclear, the claims are indefinite.
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 1-23 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Behzadian (US 2006/0074413).
Regarding claims 1-23, Behzadian discloses a medical device (fig. 1) that includes a housing (14, fig. 2A) with 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). Behzadian further teaches that the device is provided with a sensor that is a thermostat (34, [0049], fig. 4B). The output of the sensor is used by a controller (i.e. whatever circuitry is controlling power input based on temperature as discussed in [0049]) to control the temperature such that the sensor can be understood to “comprise” a controller where the controlled temperature is “optimal” according to some standard. Since the energy is not supplied for an infinite length of time, whatever time period during which energy is supplied can be considered a “timed burst.” The language in the claims directed to how the device can be used, including what temperatures are generated, the number and rate of pulses/bursts and how information from the sensor might be used, constitute functional limitations. 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, the prior art device could be connected to any hypothetical generator that would produce the claimed electrical output to produce the claimed results.
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 24 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Behzadian in view of VanScoy (US 2014/0276733).
Regarding claims 24 and 25, Behzadian does not disclose the use of a position sensor for tracking treatment sectors. However, position sensors for tracking treatment sectors are common in the art. VanScoy, for example, discloses that such sensors allow for treatment sectors to be registered on a tissue model for tracking various relevant information of the sectors ([0050], [0060]). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to modify the device of Behzadian to include a position sensor such as taught by VanScoy that would produce the predictable result of allowing the sensed information to be used to track treatment sectors. Since the claim does not recite any steps or structure that would allow a actual determination of a particular treatment sector size, any treatment sector as disclosed by VanScoy, defined to be at least a region in which treatment occurs, can be understood to have an arbitrary dimension include 1 square centimeter.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. There are a large number of probes with three electrodes in the art, but see figures 3a-b of US 2014/0276659 to Juergens for an example of a such a device used for skin tightening. For another generic example see figure 6 of US 6,117,131 to Taylor. Regarding the use of a processor that controls burst/pulse timing (commonly called “duty cycle”) to keep the temperature in a desired range, including between 50-90° C “according to clinical needs, see paragraph [0062] of US 2017/0050021 to Cosman which also discuss a pulse/burst rate of 1-10 Hz ([0087]). Regarding the more general teaching to control duty cycle as a function of temperature, see paragraph [0014] of US 2002/0161361 to Sherman. Regarding the use of a 1cm grid for showing temperatures around a probe, see figure 4 of US 2003/0065317 to Rudie.
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