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 without traverse of Group II in the reply filed on 9/2/2025 is acknowledged.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 9/28/2022 and 3/31/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
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) 5 and 11-22 are rejected under 35 U.S.C. 103 as being unpatentable over Rollins (US 2017/0367762) in view of Andres et al. (US 2019/0380766; hereafter Andres).
In regard to claim 5, Rollins discloses a method, comprising: creating a first biopsy punch opening in a skin of a body of a patient within a wheal of numbness (see par. [0069]; Fig. 2; BLOCKS 104-108); spraying a tumescent fluid within the body via a tumescent cannula inserted into the body through the biopsy punch opening (see par. [0069]-[0070]; Fig. 2; BLOCKS 110-112); extracting fat cells through the biopsy punch opening via a nutational infrasonic liposculpture (NIL) cannula driven with nutational movement within the body (see par. [0073]-[0074]; Fig. 2; BLOCK 116).
Rollins fails to expressly disclose inserting a helium plasma component into the first biopsy punch opening along a first pass path to treat the skin with a plasma stream.
In a similar art, Andres teaches devices, systems and methods for the minimally invasive application of helium-based cold plasma energy to subcutaneous tissue for the purpose of tightening lax tissue. A tip of a plasma generating handpiece is placed in the subcutaneous tissue plane through the same access ports used for SAL. Activation of the plasma generating handpiece in this plane causes contraction of the collagen contained in the dermis, the fascia, and the septal connective matrix through precise heating from the plasma energy. In an exemplary electrosurgical system generally indicated as 10 comprising an electrosurgical generator (ESU) generally indicated as 12 to generate power for the electrosurgical apparatus 10 and a plasma generator generally indicated as 14 to generate and apply a plasma stream 16 to a surgical site or target area 18 on a patient 20 resting on a conductive plate or support surface 22. The electrosurgical generator 12 includes a transformer generally indicated as 24 including a primary and secondary coupled to an electrical source (not shown) to provide high frequency electrical energy to the plasma generator 14. (see par. [0047]-[0048]). Andres further teaches employing these devices and methods in conjunction with other procedures such as liposuction and fat liquidation techniques in order to produce skin tightening of lax tissue (see par. [0098]-[0102].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Rollins with the extra step of inserting a helium plasma component to treat the skin with a plasma stream as taught by Andres in order to provide skin tightening effects to the lax tissue resulting from the fat extraction. While the examiner maintains that the ordinary skilled artisan would recognize that Andres teaches devices and steps to produce skin tightening and would consider it obvious to combine based on that teaching alone, Andres provides a further teaching that the helium plasma component can specifically be used after fat removal techniques thereby providing a direct motivation to use in conjunction with the steps and devices taught by Rollins.
In regard to claim 11, Rollins discloses further comprising jet injecting an anesthetic into the skin to raise the wheal of numbness (see par. [0014], [0022], [0030], and [0064]).
In regard to claim 12, Rollins discloses wherein the tumescent fluid is sprayed within the body using a garden spray cannula (see par. [0042], [0059], and [0070]).
In regard to claim 13, Rollins discloses further comprising implanting the extracted fat cells into the body at a second location (see at least Abstract, par. [0019], [0020], [0027], and [0028]).
In regard to claim 14, Rollins discloses wherein the implanted fat cells further comprise stem cells that were extracted with the fat cells (see par. [0020], [0028], [0030], [0078]).
In regard to claim 15, Andres teaches wherein the plasma stream tightens the skin (see at least the Abstract and highlighted par above).
In regard to claim 16, Rollins discloses wherein the first biopsy punch opening has a diameter of 5 mm or less (see par. [0069]).
In regard to claim 17, Rollins discloses wherein the first biopsy punch opening has a diameter of 2.5 mm or less (see par. [0069]).
In regard to claim 18, Rollins discloses wherein the NIL cannula has a diameter of 0.2 mm to 5 mm (see par. [0073]).
In regard to claim 19, Rollins discloses wherein the NIL cannula has a diameter of 2.7 mm to 4 mm (see par. [0073]).
In regard to claim 20, Rollins discloses wherein the NIL cannula has a diameter of 0.2 mm to 5 mm (see par. [0073]).
In regard to claim 21, Andres teaches wherein the helium plasma component comprises a plasma cannula (104) inserted through the first biopsy punch opening.
In regard to claim 22, Andres teaches wherein treating the skin with the plasma stream comprises generating the plasma stream using a helium gas and a radio frequency pulse (see par. [0054]).
Claim(s) 6-8 and 23-24 are rejected under 35 U.S.C. 103 as being unpatentable over Rollins and Andres in view of Roman et al. (US 2022/0249150; hereafter Roman).
In regard to claims 6 and 23, the combination of Rollin and Andres fails to expressly disclose or teach wherein the helium plasma component is operated at a power setting between about 24-28 watts. Andres does teach a power setting of 40 watts (see par. [0024] which is substantially close the recited range. Furthermore, the applicant fails to show a benefit to the recited range that produces a specific or unexpected result and therefore the recited range is considered to be a design consideration. In a similar art, Roman teaches a similar device and method of tightening tissue comprising employing a power setting of 24 to 32 watts which includes the recited range (see par. [0019]). Based on the design consideration nature of the recited range and that Roman teaches that such a range is already employed for a substantially similar purpose, it would have been obvious to use the range in the combination to provide a known suitable range for tissue tightening.
In regard to claim 7, the combination of Rollin and Andres fails to expressly disclose or teach wherein inserting the helium plasma component inserted into the first biopsy punch is moved at a pass rate of at least 3 cm/s. The applicant admits that the prior art methods employed a pass rate of 1-2 cm/s (see par. [0058] of the instant pg-publication). The instant disclosure describes the parameters of the recited pass rate as being merely preferable, and does not describe the recited pass rate as contributing any unexpected results to the system. As such, parameters such as the pass rate are considered to be matters of design choice, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results. Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention that the limitation of the recited pass rate would be dependent on the actual application of the system and, thus would be a design choice based on the actual application. Roman teaches a similar desired power setting (see par. [0019]) and teaches a linear relationship between passes of the plasma stream (see par. 0095]-[0097]) thereby highlighting the predictable nature of the technology.
In regard to claim 8, Rollins and Andres fail to expressly disclose or suggest further comprising inserting the helium plasma component along a second pass path, wherein a separation distance between the first pass and the second pass path is at least about 3 cm. The instant disclosure describes the parameters of the separation distance as being merely preferable, and does not describe the separation distance as contributing any unexpected results to the system. As such, parameters such as the separation distance are considered to be matters of design choice, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results. Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention that the limitation of the recited separation distance would be dependent on the actual application of the system and, thus would be a design choice based on the actual application. Roman teaches a similar desired power setting (see par. [0019]) and teaches a linear relationship between passes of the plasma stream (see par. 0095]-[0097]) thereby highlighting the predictable nature of the technology. The ordinary skilled artisan would provide enough paths to produce the desired effect.
In regard to claim 24, Roman teaches wherein the helium plasma component is operated at a flow rate in the range of 1-2 liters of gas per minute (see par. [0086]).
Claim(s) 9 is rejected under 35 U.S.C. 103 as being unpatentable over Rollins and Andres in view of Shanks et al. (US 2002/0123743; hereafter Shanks).
In regard to claim 9, Rollins fails to expressly disclose further wherein the tumescent fluid further comprises an anesthetic.
In a similar art, Shanks teaches that in the tumescent technique known in prior art, a saline solution containing very dilute amounts of at least an anesthetic and a vasoconstrictor is injected subcutaneously into the area to be suctioned. The anesthetic reduces operative and postoperative pain and the vasoconstrictor helps reduce blood loss. The added fluid forms an emulsion with the fat cells, which has a lower viscosity than the fat cells alone and is therefore easier to suction. The result is increased rate and completeness of fat removal, decreased blood loss, decreased post-operative bruising and improved recovery time. See par. [0007].
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 combination with the anesthetic-containing tumescent fluid in order to reduce operative and postoperative pain and reduce blood loss.
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