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 § 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, 4, 10 and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lischinsky et al (2007/0191827).
Regarding claim 1, Lischinsky et al provide a method for removing a papule (i.e. lesions, acne and pimples as well as other skin conditions as in para. [0072]). The method includes applying a numbing agent to a body part (para. [0077]), pre-cooling the body part (para. [0077]) and contacting the papule with a distal tip of al electrosurgical device to deliver RF alternating current to the tissue site (para. [0057], for example). Current is applied in a short burst (para. [0087] and [0089] discusses control of pulse duration) and the current is stopped short of complete destruction of the tissue site (para. [0073] and [0075], for example).
Regarding claim 2, Lischinsky et al also provide cooling after treatment (para. [0078], for example). Regarding claim 4, Lischinsky et al provide a step of confirming the treatment site using imaging and other techniques (para. 0072], for example). Regarding claim 10, Lischinsky et al provide various different types of cooling (para. [0077]). Regarding claim 15, see discussion of claim 1 where Lischinsky et al disclose the step of controlling the pulse duration (para. [0087] and [0089]).
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 and 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Lischinsky et al (‘827) in view of the teaching of Neev (6,168,590).
Lischinsky et al disclose the method of claims 1 and 2 as addressed previously. Lischinsky et al fail to expressly disclose the steps of applying an ointment after the treatment or the specific cleaning steps of claims 7-9. The examiner maintains that the use of topicals to treat skin after treatment are generally well known in the art, and that the steps of cleaning with alcohol are also generally practice in virtually any medical procedure. To that point, Neev disclose a skin treatment method (i.e. hair removal) and specifically teach that it is known clean the skin prior to and after treatment, and that it is known to provide an antibiotic ointment to prevent infection or rash after treatment. See, for example, column 11, lines 14-17 and column 13, lines 19-21. Again, the examiner maintains that cleaning protocol is generally well known in the field of dermal treatment (and virtually any medical procedure) and the use of ointments after skin treatment are also generally well known.
To have provide the Lischinsky et al method with the steps of cleaning the tissue and applying an ointment after the treatment would have been an obvious consideration for one of ordinary skill in the art at the time of the invention since Neev fairly teach such steps in a skin treatment procedure.
Claims 5, 6 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Lischinsky et al (‘827) in view of the teaching of Vitetta (2021/0196676).
Lischinsky et al fail to expressly disclose the step of confirming whether or not a patient has a history of herpes, or the specific treatment of the penis.
Vitetta discloses another method of treating various skin conditions including warts and skin or mucosal lesions. In particular, Vitetta discloses the use of electrosurgery in the method (para. [0213], for example). Further, Vitetta also discloses the step of obtaining a patient history (as is generally known in all medical procedures) including a history of herpes and the step of providing an antiviral treatment if there is a history of herpes. See, for example, paragraphs [0099-0104]. Additionally, Vitetta et al disclose the method steps of treating various skin locations and the treatment of genital herpes, so the treatment of the penis would be an obvious consideration to one of ordinary skill in the art since any affected area in need of treatment would be contemplated. Vitetta et al also disclose various different intervals for providing the treatment (claim 11, for example).
To have provided the Lischinsky et al method with the steps of confirming a patient’s history of herpes and providing treatment for herpes would have been an obvious consideration for one of ordinary skill in the art as all medical procedures generally require a complete medical history for the patient and further since Vitetta specifically teaches obtaining such a medical history and providing treatment for herpes in another skin treatment protocol. The specific location of the treatment and the intervals for treatment would also be obvious to the skilled artisan and are fairly suggested by Vitetta.
Claims 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Lischinsky et al (‘827).
Lischinsky et al provides for pre-cooling of tissue by various different means. See paragraph [0077], for example. The examiner maintains that the time of cooling would be an obvious consideration for one of ordinary skill in the art and that a specific cooling time of one minute would be within the purview of the skilled artisan. Lischinsky et al disclose electrical contact cooling devices, whereby medical electrical contact devices are commonly, and obviously, made from stainless steel. The use of any known type of cooling device is deemed to be within the purview of the skilled artisan.
Claims 13, 14 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Lischinsky et al (‘827) in view of the teaching of Bessette (2002/0133149).
Lischinsky et al fail to specifically disclose the use of magnification or the use of a pointed probe. It is noted that Lischinsky et al disclose the probe may have any desired shape necessary to treat a tissue region (para. [0043], for example).
Bessette discloses another device using RF energy to treat various skin conditions. In particular, Bessette specifically discloses that magnification of the tissue cite is contemplated to better see the treatment area (para. [0185], for example). Bessette also disclose various different probe tips for treating tissue, including probes having a pointed tip (Figures 23 and 38A, among others). Additionally, Bessette teaches of the known creation of smoke during such a procedure (par. [0008]) and specifically provide a suction means to aspirate tissue and smoke from the surgical site (para. [0109]).
To have provided the Lischinsky et al method with a means to magnify the treatment area and a pointed tip to treat tissue would have been an obvious consideration for one of ordinary skill in the art at the time of the invention since Bessette fairly teaches these are known features in a similar RF treatment of skin conditions.to have additionally provided the Lischinsky et al method with a means to remove smoke and debris from the treatment site would have been an obvious consideration for one of ordinary skill in the art at the time of the invention since Bessette fairly teaches it is known to provide such a step in a similar procedure.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Lischinsky et al (‘827) in view of the teaching of Roge (4,321,926).
Lischinsky et al disclose that the pulse length of the RF energy may be controlled, but fail to give any parameters for the length of the pulses. The examiner maintains that one of ordinary skill in the art would obviously know the appropriate power and time parameters to achieve the desired tissue effect. To that end, attention is directed to Roge who provide another RF device for the removal of hair (i.e. skin treatment) and who specifically teach that acceptable pulse lengths may be from 100ms to 2 seconds or more (col. 3, lines 65-67).
To have provided the Lischinsky et al method with any acceptable pulse duration for the RF pulses would have been an obvious consideration for one of ordinary skill in the art at the time of the invention, particularly in view of Roge who disclose pulse widths within applicant’s claimed range.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Mehl (4,174,713) disclose another RF treatment device that provides a magnifier to view tissue during treatment. See Figure 3, reference 84. Eggers et al (6,117,109) disclose another RF device for treating skin conditions that includes a suction conduit to remove smoke. Stern (6,413,255) provides another device to treat skin tissue with RF energy including a means to provide cooling of the skin surface.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph Stoklosa can be reached at (571) 272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL F PEFFLEY/Primary Examiner, Art Unit 3794
/M.F.P/ August 10, 2026
