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 .
Response Filed
Applicant’s response, filed March 25, 2026, has been entered. No claim amendments were filed.
Information Disclosure Statements
The information disclosure statements filed December 18, 2025 and March 25, 2026 have been entered and the references cited therein have been considered by the examiner.
Claim Rejections - 35 USC § 103
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.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 53-55, 58-68 and 71-78 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ginggen et al. (U.S. Patent No. 12,150,671).
In regard to claims 53, 54, 63, 64, 66, 67, 76 and 77, Ginggen et al. teach methods and apparatuses for treating skin and proximal tissue layers (such as fat) such as skin tightening or for treating diseases, disorders and conditions that would benefit from tissue area of volume reduction, skin restoration, skin tightening, skin lifting, skin repositioning or tattoo removal (see col. 1, lines 19-25). Further, Ginggen et al. teach methods and devices for treating skin by selectively opening or closing a plurality of wounds or holes (ablated tissue portions) formed by ablation without thermal energy being imparted to the surrounding (non-ablated) tissue (see col. 1, line 65 to col. 2, line 5). This non-thermal ablation is performed by fractional ablation of the epidermal and/or dermal layer of the skin by a mechanical method (hollow coring needle, drill, microauger, a tube comprising cutting teeth, a spoon bit, a wire or a fiber) or by fractional electroporation, a femtosecond laser (see col. 2, lines 5-15). Thermal ablation methods may also be used such as fractional laser ablation or fractional radio-frequency (RF) ablation (see col. 2, lines 15-20). Ginggen et al. teach that the ablated tissue portions (e.g., the treatment area or holes formed in the skin by ablation) may have a diameter of between 0.01 mm to 2 mm (see col. 16, lines 24-48). The plurality of tissue portions can be ablated in any beneficial pattern within the skin region (see col. 49, lines 15-40). Ginggen et al. also teach that a series of ablated tissue portions can result in ablation of about 10-40% of the total skin area (see col. 43, lines 62-65). Ginggen et al. do not specifically state that the area of at least one of the target regions is greater than 10 cm2 or that the surface area of the plurality of treatment regions is at least 2% of the total skin surface area. However, given the broad disclosure of Ginggen et al. of various diameters and depths of ablated tissue portions (see, e.g., col. 15, line 34 to col. 16, line 57), the disclosure of the use of the device to perform various types of ablation on different parts of the body (see, e.g., col. 43, line 25 to col. 51, line 17 and col. 60, line 20 to col. 61, line 20) and the disclosure of about 10-40% of the total skin area, it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to utilize the device of Ginggen et al. in such a manner that the area of at least one of the target regions is greater than 10 cm2 or that the surface area of the plurality of treatment regions is at least 2% of the total skin surface area. One of ordinary skill will be motivated to do so in order to optimize the use of the device of Ginggen et al. for the particular type/manner of ablation being carried out to effectuate a therapeutically acceptable result. In regard to claims 55 and 68, see col. 28, line 64 to col. 31, line 19 of Ginggen et al. In regard to claims 58-60 and 72-73, see col. 26, line 40 to col. 28, line 62 of Ginggen et al. In regard to claims 61 and 74, see col. 31, lines 43-62 of Ginggen et al. In regard to claims 62 and 75, see col. 19, line 10 to col. 24, line 3 of Ginggen et al. In regard to claims 65 and 78, Ginggen et al. do not specifically state that the surface area of the plurality of treatment regions is at least 3.6% of the total skin surface area. However, given the broad disclosure of Ginggen et al. of various diameters and depths of ablated tissue portions (see, e.g., col. 15, line 34 to col. 16, line 57), the disclosure of the use of the device to perform various types of ablation on different parts of the body (see, e.g., col. 43, line 25 to col. 51, line 17 and col. 60, line 20 to col. 61, line 20) and the disclosure of about 10-40% of the total skin area, it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to utilize the device of Ginggen et al. in such a manner that the surface area of the plurality of treatment regions is at least 3.6% of the total skin surface area. One of ordinary skill will be motivated to do so in order to optimize the use of the device of Ginggen et al. for the particular type/manner of ablation being carried out to effectuate a therapeutically acceptable result.
Claim(s) 79-81 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ginggen et al. (U.S. Patent No. 12,150,671) in view of Daly et al. (U.S. Patent Application Publication No. 2020/0391051).
In regard to claims 79-81, Ginggen et al. are silent as to a scanning arrangement to direct energy onto the treatment regions where the scanning arrangement is multi-axis robot arm or an actuator and a platform. However, Daly et al. teach a similar aesthetic system 10 for performing a variety of aesthetic procedures where the system 10 includes a positioning apparatus 900 (robot arm) for permitting movement, control and positioning of a device 950 (treatment head) (see Fig. 1 and para. 0093). The positioning apparatus 900 provides a multi-axis, computer-controlled mechanism for controlled movement, orientation and positioning of the device 950 including movement over a predefined treatment zone (see para. 0093). Daly et al. also teach the user of a treatment platform on which the patient is positioned and then the system 100 with the positioning apparatus 900 is placed in position for use (see para. 0172). Daly et al. thus demonstrate that the use of a positioning apparatus and a platform for use in a system designed for aesthetic treatment of the skin is well known and desirable in the art so that the device can be properly positioned relative to the patient to carry out the desired treatment. Accordingly, it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to provide the device of Ginggen et al. with the positioning apparatus and platform taught by Daly et al. in order to provide the device of Ginggen et al. with the ability to properly position the skin treatment apparatus relative to the patient to carry out the desired treatment.
Response to Arguments
Applicant's arguments filed March 25, 2026 have been fully considered but they are not persuasive.
Applicant argues that the total skin area ablated in Ginggen et al. is not the entire skin surface of a subject, but rather of a particular “high laxity” skin region (see page 3 of the response filed 3/25/2026). Applicant also argues that the only description in Ginggen et al. of a total area of skin being removed is 2500 mm2, which is significantly less than 2% of an average person’s total skin area (see page 4 of the response filed 3/25/2026). Applicant also argues that the examiner’s rationale (for why one of ordinary skill in the art would be motivated to use the device of Ginggen et al. for the particular type/manner of ablation being carried out) is merely a conclusory statement and may amount to Official Notice (see page 4 of the response filed 3/25/2026). Applicant also argues that there would be no motivation to combine the robotic scanning device of Daly with the ablation methods and device of Ginggen et al. (see page 5 of the response filed 3/25/2026).
In response to the argument that Ginggen et al. only discuss ablations of “high laxity” skin regions, it is apparent that the broad disclosure of ablation of 10-40% of a “high laxity” skin area is at least capable of constituting at least 10% of the total skin surface area to be treated or at least 2% of the total skin surface area of the subject. Furthermore, at col. 46, lines 45-62 of Ginggen et al., there are broad ranges of areal fractions of skin to be treated that are disclosed, ranging from 5% up to 80%. Accordingly, given this very broad disclosure which clearly indicates that the device of Ginggen et al. is intended for broad applications, it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to utilizes the device of Ginggen et al. for the particular type/manner of ablation being carried out to effectuate a therapeutically acceptable result. As such, the examiner is not invoking Official Notice but is relying upon the broad disclosure of Ginggen et al. In response to applicant’s arguments that one of ordinary skill in the art would not be motivated to combine Ginggen et al. and Daly et al., applicant is referred to the examiner’s explanation above. Furthermore, applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references. In other words, applicant has not demonstrated that Ginggen et al. and Daly et al. cannot be combined, only that they should not be combined.
Conclusion
THIS ACTION IS MADE FINAL. 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 BEVERLY MEINDL FLANAGAN whose telephone number is (571)272-4766. The examiner can normally be reached Mon-Fri 7:30AM to 5:00PM.
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/BEVERLY M FLANAGAN/Primary Examiner, Art Unit 3794
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