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 .
Election/Restrictions
Applicant’s election with traverse of Species D in the reply filed on 12/29/2025 is acknowledged. The arguments are persuasive and the species restriction is withdrawn.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/13/2022 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
Claim(s) 1, 5, 11, 23-26, and 30-34 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Clark, III et al. (US 2011/0028898; hereafter Clark).
In regard to claim 1, Clark discloses a system for treating an expression of cellulite on a skin (204) of a patient, the system comprising: a handpiece (100) including a base (202) having a chamber (105) and a conduit (213) through the base providing access to the chamber (see Fig. 2A) and an upper portion (201) above the chamber (see Fig. 2A), wherein the chamber is configured to receive the skin (see Fig. 2A), and the upper portion is configured to lift the skin (see par. [0075]); and a treatment device (102) having a shaft (see shaft of 102; see Fig. 2A) and a septa engaging assembly (see blades in Fig. 2A and various blade embodiments in Fig. 18-21B) attached to the shaft, wherein the shaft is configured to be inserted through the conduit and through the skin received in the chamber (see Fig. 2A), and the septa engaging assembly is configured to engage a septum to treat the expression of cellulite (see Fig. 2A and par. [0135], [0138], and [0156]).
In regard to claim 5, Clark discloses wherein the treatment device (102) is steerable (see Fig. 2A; insertion through the conduit into the skin is considered to be steering).
In regard to claim 11, Clark discloses further comprising a source of suction for pulling the skin in the chamber (see par. [0025], [0075], and [0078]).
In regard to claim 23, Clark discloses wherein the treatment device (see embodiments in Figs. 18-21B) includes a first link (upper 2004) and a second link (lower 2004), the first link includes a blade (1902), and the second link is configured to shield the blade from contacting tissue when the treatment device is in a hooking configuration (the first and second link both retract blades 1902 into a concealed configuration; the hooking configuration is broadly recited and could be interpreted as the concealed configuration; see par. [0141]).
In regard to claim 24, Clark discloses wherein the first link has a first end (2005) pivotably attached the shaft (see par. [0143]-[0144]).
In regard to claim 25, Clark discloses wherein the upper portion (see embodiment in Figs. 13A-13B) has a lower platform (1303 and/or 1301) and an upper platform (1302).
In regard to claim 26, Clark discloses wherein the upper platform (1302) has a width larger than a width of the lower platform (at least 1301).
In regard to claim 30, Clark discloses wherein the base (202) is ring-shaped (see at least Figs. 1C and 2A).
In regard to claim 31, Clark discloses wherein the base (see embodiment in Figs. 13A-13B) has an upper opening (see opening at top of 1307) configured to receive the upper portion (1301, 1302).
In regard to claim 32, Clark discloses wherein the handpiece (100) has a second conduit (208), wherein the shaft is configured to be inserted through the second conduit (functional limitation; see Fig 2A; the shaft is capable of being inserted into 208 as 208 is similar in size and shape to 213).
In regard to claim 33, Clark discloses wherein the conduit (203) and the second conduit (208 are circumferentially disposed around a perimeter of the base (see Fig. 2A).
In regard to claim 34, Clark discloses wherein the treatment device (see embodiments in Figs. 19C-20) has an actuator (2002) configured to actuate the septa engaging assembly between a concealed configuration (“constrained position” where blades are not deployed; see par. [0141]), a septa tensioning configuration (the position(s) between concealed and fully deployed), and a septa disruption configuration (position where blades are fully deployed; see Fig. 20 and par. [0141]). The claim is broad in that the functions are not recited in each configuration.
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.
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.
Claim(s) 6 is rejected under 35 U.S.C. 103 as being unpatentable over Clark in view of Perry et al. (US 2015/0064165; hereafter Perry).
In regard to claim 6, Clark is silent as to wherein the septa engaging assembly includes a side opening hook.
In a similar art, Perry discloses a septa engaging assembly (24) including a hook (34) configured to grasp the septae (see par. [0027]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Clark with the septa engaging assembly of Perry since Perry’s assembly is an equivalent means for severing septae causing cellulite and substituting equivalents to perform the same function to achieve predictable results is considered well within the skill of the ordinary artisan.
Claim(s) 2-4 are rejected under 35 U.S.C. 103 as being unpatentable over Clark in view of Brigatti et al. (US 2010/0004581; hereafter Brigatti).
In regard to claims 2-4, Clark is silent to wherein the treatment device has a light configured to generate transillumination, wherein the light is positioned along a distal portion of the shaft, and wherein the light is one or more of an LED and/or a lightguide.
In a similar art, Brigatti discloses a treatment device (100) has a light (610) configured to generate transillumination (see par. [0212]), wherein the light (610) is positioned along a distal portion of the shaft (see Fig. 2B), and wherein the light is one or more of an LED and/or a lightguide (see par. [0212]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Clark with the light of Brigatti in order to add a means for detecting the position of the needle under the skin via transillumination.
Claim(s) 12, 15, 27, 28, and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Clark in view of Sonoda et al. (US 2008/0015624; hereafter Sonoda).
In regard to claims 12, 15, 27, 28, and 29, Clark is silent further comprising an adhesive on a lower surface of the upper portion configured to engage the skin when in the chamber, wherein the handpiece includes a spring configured to bias the upper portion away from the base, wherein the lower platform has an adhesive to engage the skin, further comprising a spring disposed between the base and the upper platform, and wherein the spring is disposed around the lower platform.
In a similar art, Sonoda teaches a puncture device (1) for lifting the skin and making a lateral injection through the lifted skin, wherein the device includes an adhesive (34) on a lower surface of the upper portion (331) configured to engage the skin when in the chamber (see at least Figs. 7A-7C), wherein the handpiece includes a spring (32) configured to bias the upper portion (331) away from the base (see Figs. 7A-7C), wherein the lower platform has an adhesive (34 or adhesive on 2) to engage the skin, further comprising a spring (32) disposed between the base (2) and the upper platform (331), and wherein the spring is disposed around the lower platform (see Figs. 7A-8C).
It would have been obvious to one of ordinary skin in the art before the effective filing of the claimed invention to modify the device of Clark with the skin lifting means of Sonoda because substituting equivalents to perform the same function to achieve predictable results is considered well within the skill of the ordinary artisan.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THEODORE J STIGELL whose telephone number is (571)272-8759. The examiner can normally be reached M-F 9-5:30 EST.
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THEODORE J. STIGELL
Primary Examiner
Art Unit 3783
/THEODORE J STIGELL/ Primary Examiner, Art Unit 3783