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 .
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.
Claim(s) 1 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Khen (WO 2008/063478 A1) in view of Ben-Haim (WO 2013/019785 A1).
Regarding claim 1, Khen discloses a handpiece (Apparatus 200, Figure 1 and Page X) capable of attaching/detaching a vacuum cap (the treatment tip 300 may be an attachable/detachable tip that can be attached to an external system that includes for example a pump, Figures 2A-2D and Page 11 lines 12-15) and adjusting an angle of the vacuum cap (as the apparatus 200 and treatment tip 300 are hand-held devices, the device is fully capable of being tilted by the user and therefore adjusting an angle of the treatment tip 300, Figures 1-2a), the handpiece comprising: a vacuum cap (treatment tip 300, Figure 2A) having an open bottom surface (see treatment tip 300 having an open bottom surface 308, Figure 2a), and formed therein with a hollow part (opening 308 defining a chamber 312, Figure 2a and Page 11 lines 20-25); a body part to/from which the vacuum cap is attached/detached (the treatment tip 300 may be an attachable/detachable tip that can be attached to an external system that includes for example a pump, therefore the body of the external system such as the pump serves as the body part, Figures 2A-2D and Page 11); a vacuum device for providing a reference negative pressure to the vacuum cap so that a target site of skin is adsorbed toward the hollow part of the vacuum cap (a vacuum may be created in the chamber 312 to cause periodic physical movement of the area of the tissue being treated, Page 11 lines 27-31); a reference negative pressure variable device for varying the reference negative pressure in a pulse form under a condition in which the hollow part of the vacuum cap maintains a negative pressure (a vacuum pulse sequence may be created in the chamber 312 to cause periodic physical movement of the area of the tissue being treated, Page 11 lines 30-31 and Figure 3A; vacuum pulses may be activated and/or stopped manually via a push-button and/or a solenoid valve 254, Page 7 lines 6-7); an RF electrode exposed to an inside wall of the vacuum cap so that the adsorbed skin makes contact with an inside the hollow part of the vacuum cap when the target site of the skin is adsorbed toward the hollow part of the vacuum cap (energy transmitting elements 220 and 230 disposed on inner walls of chamber may impart radio frequency energy to the tissue 290 that is substantially received in the volume defined by the chamber 240, Figure 1 and Page 7 lines 19-25); and a control unit for controlling driving of the vacuum device (vacuum pump 250 is controlled by a control module 224 to drive the pump, Figure 1 and Page 6 lines 18-30), the reference negative pressure variable device (the vacuum pulses produced by the vacuum pump 250 are controlled by the control module 224, Figure 1 and Page 6 lines 18-30; see also Figures 3a-3b showing variable vacuum pulses), and the RF electrode (the energy transmitting elements 220 and 230 also controlled via the control module 224, Page 5 line 6 lines 1-5), wherein the driving of the reference negative pressure variable device and the RF electrode for treating the target site of the skin is controlled by selecting one of single driving, simultaneous driving, and alternating driving (the sequence of vacuum pulses 350 and corresponding RF pulses delivered by the apparatus 200 and treatment tip 300 may be single driving, simultaneous and/or alternating, Page 13 lines 31-34 and Figures 3A-3B), and the attachment/detachment of the vacuum cap to/from the body part is performed by simultaneous coupling and simultaneous separation of a vacuum cap connection unit including a vacuum tube coupler (upper body 320 of tip 300 may include a lumen 326 that is coupled to the vacuum pump, Figure 2C and Page 12 line 13), a power supply connector which are provided at an end of the body part (electronic board 324 may be disposed in a head section of the external system having an interface to enable attachment of the tip 300 thereto, Page 12 line 8).
However, although Khen’s device teaches a coupling mechanism between a vacuum cap and the body part (attachable/detachable treatment tip 300 may be secured through a suitable interfacing mechanism to an external system Page 11 lines 8-10), Khen doesn’t explicitly state the connection unit comprising a clip.
However, Ben-Haim teaches a tissue interface device (Abstract and Figure 1) configured to impart a negative vacuum force to the tissue of the user (Paragraph 0031), comprising a detachable cap (tissue interface module 116, Figure 3 and Paragraph 0075) connected to a body part (applicator hand piece 114, Figures 1-3 and Paragraph 0071) wherein the cap is connected to the body part of the device via a clip (attachment mechanism includes a clip cover 168, Figure 9 and Paragraph 0087).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Khen’s device such that the connection mechanism between the cap and the body part of the device comprises a clip structure, as taught by Ben-Haim, as providing a clip structure between two mating components is an art recognized means of physically securing two components together in a safe and effective manner, and may offer benefits such as quicker assembly/disassembly.
Regarding claim 3, Khen further teaches wherein the reference negative pressure variable device (a vacuum pulse sequence may be created in the chamber 312 to cause periodic physical movement of the area of the tissue being treated, Page 11 lines 30-31 and Figure 3A; vacuum pulses may be activated and/or stopped manually via a push-button and/or a solenoid valve 254, Page 7 lines 6-7) is configured to vary the reference negative pressure in the pulse form having a period corresponding to 0.5 to 50 times per second by a pressure variable valve under the condition in which the hollow part of the vacuum cap maintains the negative pressure (the sequence of vacuum pulses 350 that can be delivered by the apparatus 200 that includes the treatment tip 300 may be implemented through the use of the solenoid valve 254 and by using the control module to generate actuating signals; the number of pulses 350 and period T of the pulses are controlled via user input, therefore fully capable of producing pulses in the range of 0.5 to 50 times per second, see also Figure 3A-3B and Page 15), and the vacuum device is configured to automatically operate to maintain the reference negative pressure when the reference negative pressure within the hollow part is out of a set range due to an adhesion failure occurring in a contact portion between the vacuum cap and the skin (if the vacuum level in the chamber is measured to not have exceeded the threshold, therefore the apparatus has not made sufficient contact with the users skin, the vacuum level is maintained at a higher level by further evacuation of air, Page 15).
Claims 2 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Khen (WO 2008/063478 A1) in view of Ben-Haim (WO 2013/019785 A1) and in further view of Beerwerth (EP 3263177 A2).
Regarding claim 2, Khen in view of Ben-Haim teach the handpiece of claim 1, with Khen further teaching wherein the body part includes: a first body part to/from which the vacuum cap is attached/detached, and the vacuum cap connection unit is provided at an end of the first body part (upper body part 320 includes an attachment mechanism to attach the tip 300 to the external system such as a pumping device, Page 12 lines 3-5), however is silent on a second body part coupled to the first body part with an angle adjustment device, which is configured as a joint member or a rotation shaft, interposed between the first body part and the second body part so that a user bends the second body part to adjust an angle between the first body part and the second body part.
However, Beerwerth teaches a skin treatment device (Abstract and Figure 1) comprising a first body part (handle 1, Figure 1) coupled to a second body part (applicator 2, Figure 1) via an angle adjustment device configured as a joint member or rotation shaft (pipe 6 may be provided with a flexible segment 13 to permit swiveling between the applicator head 2 and handle 1, Paragraph 0041 and Figure 7) interposed between the first and second body part so that a user bends the second body part to adjust an angle between the first and second body part (the flexible segment 13 allows the user to bend the device is various angles during use, Paragraph 0041 and Figures 6a-6c).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Khen’s device such that the first body part and second body part are coupled to one another via an angle adjustment device to therefore allow the user to bend the device, as taught by Beerwerth, as providing such flexibility to the device increases the useability of the device by allowing the user to reach difficult to reach body areas due to the adjustable angle (Paragraph 0041-0042 of Beerwerth).
Regarding claim 4, Khen in view Ben-Haim and Beerwerth teach the handpiece of claim 2, with Khen further teaching further teaches wherein the reference negative pressure variable device (a vacuum pulse sequence may be created in the chamber 312 to cause periodic physical movement of the area of the tissue being treated, Page 11 lines 30-31 and Figure 3A; vacuum pulses may be activated and/or stopped manually via a push-button and/or a solenoid valve 254, Page 7 lines 6-7) is configured to vary the reference negative pressure in the pulse form having a period corresponding to 0.5 to 50 times per second by a pressure variable valve under the condition in which the hollow part of the vacuum cap maintains the negative pressure (the sequence of vacuum pulses 350 that can be delivered by the apparatus 200 that includes the treatment tip 300 may be implemented through the use of the solenoid valve 254 and by using the control module to generate actuating signals; the number of pulses 350 and period T of the pulses are controlled via user input, therefore fully capable of producing pulses in the range of 0.5 to 50 times per second, see also Figure 3A-3B and Page 15), and the vacuum device is configured to automatically operate to maintain the reference negative pressure when the reference negative pressure within the hollow part is out of a set range due to an adhesion failure occurring in a contact portion between the vacuum cap and the skin (if the vacuum level in the chamber is measured to not have exceeded the threshold, therefore the apparatus has not made sufficient contact with the users skin, the vacuum level is maintained at a higher level by further evacuation of air, Page 15).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Anderson et al. (US 7,842,029 B2) and Ella et al. (US 2004/0260210 A1).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH B LEDERER whose telephone number is 571-272-7274. The examiner can normally be reached on Monday - Friday, 7:30 AM - 4:30 PM.
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/SARAH B LEDERER/Examiner, Art Unit 3785
/MARGARET M LUARCA/Primary Examiner, Art Unit 3785