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 .
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 16 and 17 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.
Claim 16 fails to provide sufficient antecedent basis for “RF pulse delivery” and “RF pulses” in section (d) of the claim. Claim 17 is unclear in that it appears claim 16 is delivering RF energy and not the other energy sources listed.
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 5, 7, 8, 10, 11, 13 and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Weber (10,603,101).
Regarding claim 5, Weber provides a method for thermal fat destruction for tissue tightening (col. 163, lines 30-57, for example) comprising the steps of inserting a distal portion of a cannula that has one or more electrodes into adipose tissue (col. 163, lines 30-57, where “lysing members” are electrodes, i.e. electrodes 206) and moving the cannula parallel to the skin surface (e.g. to create a flap). Pulses of energy are delivered to tissue to coagulate tissue, with the pulses being shorter than a time required for full displacement of the cannula tip. Column 131, lines 1-24 disclose the use of pulses with a pulse width of 80ms, which time duration is so short as to preclude movement of the cannula tip fully.
Regarding claim 7, see column 131 citation above. Regarding claim 8, the pulses are applied between two or more electrodes (e.g. 206). Regarding claims 10 and 11, Weber provides a sensor on the cannula to provide movement/location or temperature of the tip (col. 98, lines 60-67, for example). Regarding claim 13, see column 75, lines 45-50 which gives the size of the lysing tip that would inherently be capable of creating a coagulation zone in the claimed range. Regarding claim 15, Weber discloses the use of the device for skin tightening (as mentioned previously) as well as various other procedures.
Claims 5, 7-11, 13 and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mulholland (8,103,355).
Regarding claim 5, Mulholland provides a method for thermal fat destruction and tissue tightening (Abstract, for example) comprising the steps of inserting a distal portion of a cannula with on or more electrodes into adipose tissue (Figure 3, for example) and moving the cannula parallel to the skin to treat tissue (col. 4, lines 44-55, for example). RF pulses are delivered to tissue (col. 6, lines 27-38) which may be in the millisecond range (col. 8, line 2, for example) which would necessarily be of a duration shorter than a time required for full displacement of the cannula tip, and the pulses are intended to coagulate tissue (col. 3, lines 27-33, for example).
Regarding claim 7, see column 8, line 2 as addressed above. Regarding claim 8, the tip may have multiple electrodes (col. 5, lines 44-46 and col. 8, lines 23-24, for example). Regarding claim 9, Mulholland also provides for an external ground electrode (col. 7, lines 53-57, for example). Regarding claim 10, Mulholland teach the use of a movement sensor to monitor probe movement (col. 6, lines 22-26, for example). Regarding claim 11, Mulholland also disclose the use of temperature sensors (col. 8, lines 23-24). Regarding claim 13, Mulholland discloses a tip/treatment size that would inherently be capable of creating a coagulation zone of the claimed size (col. 7, lines 64-67, for example). Regarding claim 15, Mulholland disclose the step of skin tightening (Abstract, for example) as well as other procedures.
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, 2, 4, 6, 12, 14, 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Weber (‘101) in view of the teaching of Altshuler et al (2009/0248004).
Regarding claim 1, Weber discloses a method for thermal destruction of fat tissue and skin tightening as addressed with respect to claim 5 above. Weber discloses the steps of inserting a distal portion of a cannula having multiple electrodes into adipose tissue and moving the cannula parallel to the skin surface while applying pulses of RF energy to tissue. See discussion of claim 5 above. Weber also provides a motion sensor to monitor probe movement, but fails to expressly disclose synchronizing probe movement with the pulsing of energy to avoid overlapping coagulation zones.
Altshuler et al provide another method for skin treatments including destruction of adipose tissue to cause skin tightening (para. [0071], for example). Altshuler et al provide pulses of electromagnetic energy to thermally treat tissue, and specifically teach of synchronizing the pulse delivery with the movement of the probe to avoid overlapping of treatment areas (para. [0239], for example). To have provided the Weber device, which employs a motion sensor, with a means to synchronize pulse delivery with the sensed movement of the probe to avoid overlapping treatment areas would have been an obvious consideration for one of ordinary skill in the art at the time of the invention since Altshuler et al fairly teach such a method step in a similar procedure.
Regarding claim 2, Weber disclose multiple electrodes (206) for providing pulses of RF energy to tissue. Regarding claim 4, Weber disclose monitoring temperature of tissue (col. 98, lines 60-67, for example). Regarding claim 6, the examiner maintains that any practical speed for movement of the probe would be within the purview of the skilled artisan and would be an obvious consideration for a given procedure. It is noted that applicant fails to disclose any specific means for determining such a speed, and the speed is only mentioned in the claims and not is the description of the application. Regarding claim 12, see discussion of claim 13 above. Regarding claim 14, see discussion of claim 15 above.
Regarding claim 16, see discussion of claims 1 and 5 above. Regarding claim 17, Weber disclose an energy source providing electrical current (i.e. RF energy).
Claims 1-4, 6, 12, 14, 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Mulholland (‘355) in view of the teaching of Altshuler et al (2009/0248004).
Regarding claim 1, Mulholland discloses a method for thermal destruction of fat tissue and skin tightening as addressed with respect to claim 5 above. Mulholland discloses the steps of inserting a distal portion of a cannula having multiple electrodes into adipose tissue and moving the cannula parallel to the skin surface while applying pulses of RF energy to tissue. See discussion of claim 5 above. Mulholland also provides a motion sensor to monitor probe movement, but fails to expressly disclose synchronizing probe movement with the pulsing of energy to avoid overlapping coagulation zones.
Altshuler et al provide another method for skin treatments including destruction of adipose tissue to cause skin tightening (para. [0071], for example). Altshuler et al provide pulses of electromagnetic energy to thermally treat tissue, and specifically teach of synchronizing the pulse delivery with the movement of the probe to avoid overlapping of treatment areas (para. [0239], for example). To have provided the Mulholland device, which employs a motion sensor, with a means to synchronize pulse delivery with the sensed movement of the probe to avoid overlapping treatment areas would have been an obvious consideration for one of ordinary skill in the art at the time of the invention since Altshuler et al fairly teach such a method step in a similar procedure.
Regarding claim 2, Mulholland discloses multiple electrodes on the cannula (col. 8, lines 23-24). Regarding claim 3, Mulholland disclose a return electrode in a monopolar arrangement (col. 7, lines 53-57). Regarding claim 4, Mulholland discloses the use of a temperature sensor (see claim 11 above). Regarding claim 6, the examiner maintains that any practical speed for movement of the probe would be within the purview of the skilled artisan and would be an obvious consideration for a given procedure. It is noted that applicant fails to disclose any specific means for determining such a speed, and the speed is only mentioned in the claims and not is the description of the application. Regarding claim 12, see discussion of claim 13 above. Regarding claim 14, see discussion of claim 15 above.
Regarding claim 16, see discussion of claims 1 and 5 above. Regarding claim 17, Mulholland disclose an energy source providing electrical current (i.e. RF energy).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Weber (‘101) in view of the teaching of Altshuler et al (2009/0248004) and further in view of the teaching of Mulholland (‘355)
Weber fails to disclose a monopolar arrangement with a return electrode applied to the skin surface. The examiner maintains that it is generally well known to operate RF electrosurgical devices in either the monopolar or the bipolar mode. In particular, Mulholland provides a similar system and specifically state the device may be used in a bipolar mode (col. 5, lines 44-46) or in a monopolar mode with an external ground pad (col. 7, lines 53-57, for example).
To have provided the Weber device, as modified by the teaching of Altshuler et al, with a ground pad electrode on the skin surface to operate on a monopolar mode would have been an obvious modification for one for ordinary skill in the art at the time of the invention since Mulholland fairly teaches such a device may be used in either mode.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Weber (‘101) in view of the teaching of Mulholland (‘355).
Weber fails to disclose a monopolar arrangement with a return electrode applied to the skin surface. The examiner maintains that it is generally well known to operate RF electrosurgical devices in either the monopolar or the bipolar mode. In particular, Mulholland provides a similar system and specifically state the device may be used in a bipolar mode (col. 5, lines 44-46) or in a monopolar mode with an external ground pad (col. 7, lines 53-57, for example).
To have provided the Weber device with a ground pad electrode on the skin surface to operate on a monopolar mode would have been an obvious modification for one for ordinary skill in the art at the time of the invention since Mulholland fairly teaches such a device may be used in either mode.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Weber (2015/0359585) disclose another system for thermal ft destruction to cause tissue tightening.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL PEFFLEY whose telephone number is (571)272-4770. The examiner can normally be reached Mon-Fri 8 am-5 pm.
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/MICHAEL F PEFFLEY/Primary Examiner, Art Unit 3794
/M.F.P/December 19, 2025