DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Information Disclosure Statement
The information disclosure (IDS) submitted on 10/15/2022 and 02/19/2022 has been considered by the examiner.
Claim Status
A complete action on the merits of claims 16-27 follows below.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claims 16, 20, 24, 26, and 27 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Gliklich (2007/0032784) in view of Panescu (2006/0089688) and in further view of Smith (Patent 4,598,709).
Regarding claim 16, Gliklich teaches a cosmetic method for treating a patient’s skin (targeted muscle ablation for reducing signs of aging), comprising:
providing an array of needles [0048],
deploying the array of needles to a specific depth into the patient’s skin such that at least a tip of one of the array of needles is deployed within the muscle layer of the patients skin ([0048] an array of needles carrying electricity is inserted through the skin and positioned within the target volume 44 of muscle);
providing one or more radiofrequency transmitters coupled to the array of deployed needles ([0048] The ablative energy may be in the form of electromagnetic radiation (e.g., radiofrequency)),
providing [[DC]] current for a pre-selected amount of time to treat muscles and/or muscle nerve cells in the muscle region of the patient’s skin ([Abstract] A method and system for delivering energy to affect the signs of aging is described. Energy is delivered to a target volume of a muscle such that the energy creates a lesion in the target volume…[0048] As current flows between needles, ohmic heating cauterizes the target volume 44 of muscle);
transmitting RF radiation from the one or more RF transmitters for a pre-selected period of time to heat up the deployed needles and patient’s skin (applicator 36 provides for radiofrequency energy 42).
Gliklich does not teach providing a DC power source, applying a negative DC voltage from the DC power source to said array of deployed needles to form a closed DC current, providing the DC current for a pre-selected time amount of time to treat muscles and/or muscle nerve cells in the muscle region of the patient’s skin.
However, Panescu teaches a method within the same field of invention (method and apparatus to reduce wrinkles in the skin tissue of a patient [Abstract]), providing a DC power source ([0047] other types of non-thermal energy such as direct current DC can be transferred into the skin tissue through the probe (Fig. 1 console)), applying a negative voltage from the power source (electrode probe 12 delivers the current and element 26 is return element that is in contact with the patient to provide a return path [0024]), providing DC current for a preselected amount of time to treat muscles and/or muscle nerve cells in the muscle region ([0022] Once the nerve is traced, the electrode can be inserted into the skin at various locations, either at or adjacent to the nerve, and deliver energy into the tissue at a level sufficient to disrupt interaction between the nerve and the adjacent muscle. The energy may damage the nerve or the nerve/muscle interface. The damage may either be permanent or temporary. Once the nerve/muscle interaction is disrupted the muscle will be relaxed and the wrinkle(s) will either be removed or reduced).
Therefore, it would have been obvious to one of ordinary skill in the art to provide for a DC power source, applying a DC voltage to form a closed circuit of DC current to the muscle layer, forming a closed loop, providing DC current for a preselected amount of time to treat muscles for the purposes of disrupting the nerve/muscle interaction whereby wrinkles will either be removed or reduced.
Glicklich is silent about specifically teaching wherein the RF radiation is transmitted separately from the application of DC voltage and only when the DC voltage is turned off and vice versa.
However, Smith teaches a cosmetic method ([Abstract] electrolysis machine which utilizes an electrically conductive probe to be physically inserted below the surface of the skin to be located next to a hair shaft within the hair follicle ) wherein the RF radiation is transmitted separately from the DC voltage ([Abstract] The electrolysis machine includes two completely separate circuits. One circuit uses a direct current, while the other circuit emits a radio frequency…Col. 7 lines 23-25 If the switch 144 is not in this position, the direct current and the radio frequency are supplied independently and can be adjusted independently).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made modify the method to transmit RF radiation separate from the application of DC voltage for the purposes of controlling the therapy and it would further be obvious to have both modes of therapy since RF is capable of heating the tissue while direct current (non thermal) can provide for muscle stimulation as taught in Panescu.
Regarding claim 20, Glicklich in view of Panescu and Smith teaches the limitations of claim 16 as previously rejected above. Glicklich teaches wherein said array of deployed needles are deployed so as to locate their tips below the subcutaneous layer (muscle layer, see claim rejection 1).
Regarding claim 24, Glicklich in view of Panescu and Smith teaches the limitations of claim 16 as previously rejected above. Glicklich does not teach wherein said array of deployed needles are partially insulated and the tips of the array of needles are not insulated. However, Panescu teaches the electrode can include an insulated portion and a non-insulated tip (claim 18). Therefore, it would have been obvious to one of ordinary skill in the art to modify the array of needles in Glicklich such that a portion is insulated and the tip are not insulated for the purpose of allowing current to flow in the desired direction.
Regarding claim 26, Glicklich in view of Panescu and Smith teaches the limitations of claim 16 as previously rejected. Panescu teaches wherein the array of deployed needles each serve as a cathode (electrode probe 12 delivers the current) and wherein the positive electrode serves as an anode ([0045] The ground element could be configured as a ring 50 worn on the patient's finger, a wristband 26 wrapped around the patient’s wrist or a rod 52 held by the patient).
Regarding claim 27, Gliklich teaches an apparatus for cosmetically treating a patient’s skin (targeted muscle ablation for reducing signs of aging), comprising:
an array of needles [0048],
the array of needles being configured to be deployed to a specific depth into the patient’s skin such that at least a tip of one of the array of needles is deployed within the muscle layer of the patient’s skin ([0048] an array of needles carrying electricity is inserted through the skin and positioned within the target volume 44 of muscle);
providing one or more radiofrequency transmitters coupled to the array of deployed needles ([0048] The ablative energy may be in the form of electromagnetic radiation (e.g., radiofrequency)),
[[DC]] current is configured to be applied for a pre-selected amount of time to treat muscles and/or muscle nerve cells in the muscle region of the patient’s skin ([Abstract] A method and system for delivering energy to affect the signs of aging is described. Energy is delivered to a target volume of a muscle such that the energy creates a lesion in the target volume…[0048] As current flows between needles, ohmic heating cauterizes the target volume 44 of muscle);
one or more radiofrequency (RF) transmitters coupled to the array of deployed needles
wherein RF radiation from the one or more RF transmitters is configured to be transmitted for a pre-selected period of time to heat up the deployed needles and the patient’s skin (applicator 36 provides for radiofrequency energy 42 [0048] ohmic heating cauterizes the target volume 44 of muscle).
Gliklich does not teach a DC power source, wherein a negative DC voltage is configured to be applied to said array of deployed needles from the DC power source while the patient is in contact with a positive electrode that forms a closed circuit of DC current through the patient’s body, providing the DC current for a pre-selected time amount of time to treat muscles and/or muscle nerve cells in the muscle region of the patient’s skin.
However, Panescu teaches a device within the same field of invention (an apparatus to reduce wrinkles in the skin tissue of a patient [Abstract]), a DC power source ([0047] other types of non-thermal energy such as direct current DC can be transferred into the skin tissue through the probe (Fig. 1 console)), wherein a negative DC voltage is configured to be applied to a needle (electrode probe 12 delivers the current and element 26 is return element that is in contact with the patient to provide a return path [0024]), DC current is configured to be applied for a pre-selected amount of time to treat muscles in the muscle region of the patient’s skin ([0022] Once the nerve is traced, the electrode can be inserted into the skin at various locations, either at or adjacent to the nerve, and deliver energy into the tissue at a level sufficient to disrupt interaction between the nerve and the adjacent muscle. The energy may damage the nerve or the nerve/muscle interface. The damage may either be permanent or temporary. Once the nerve/muscle interaction is disrupted the muscle will be relaxed and the wrinkle(s) will either be removed or reduced).
Therefore, it would have been obvious to one of ordinary skill in the art to provide for a DC power source, apply a DC voltage to form a closed circuit of DC current to the muscle layer, forming a closed loop, providing DC current for a preselected amount of time to treat muscles for the purposes of disrupting the nerve/muscle interaction whereby wrinkles will either be removed or reduced.
Glicklich is silent about specifically teaching wherein the RF radiation is transmitted separately from the application of DC voltage and only when the DC voltage is turned off and vice versa.
However, Smith ‘709 teaches a cosmetic device ([Abstract] electrolysis machine which utilizes an electrically conductive probe to be physically inserted below the surface of the skin to be located next to a hair shaft within the hair follicle ) wherein the RF radiation is transmitted separately from the DC voltage ([Abstract] The electrolysis machine includes two completely separate circuits. One circuit uses a direct current, while the other circuit emits a radio frequency…Col. 7 lines 23-25 If the switch 144 is not in this position, the direct current and the radio frequency are supplied independently and can be adjusted independently).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made modify the method to transmit RF radiation separate from the application of DC voltage for the purposes of controlling the therapy and it would further be obvious to have both modes of therapy since RF is capable of heating the tissue while direct current (non thermal) can provide for muscle stimulation as taught in Panescu.
Claims 17 and 25 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Gliklich (2007/0032784) in view of Panescu (2006/0089688), Smith (Patent 4,598,709), and in further view of Manstein (Pub. No.2005/0222565).
Regarding claim 17 the combination teaches the limitations of claim 16 as previously rejected above. The combination does not teach further comprising providing hollow conduits in said array of needles and the step of supplying liquids into the skin through hollow conduits formed in said needles.
However, Manstein teaches a skin treatment device comprising a hollow conduits formed in needles 440, channel 450 Fig. 4 configured to deliver solution from a source into the tissue [0406].
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the needles such that they are hollow and provide liquid to the skin since Manstein teaches the channels 450 may be used to deliver a local analgesic solution from a source into tissue 305 to reduce or eliminate pain cause by the thermal damage process [0046].
Regarding claim 25, the combination teaches the limitations of claim 16 as previously rejected above. The combination is silent about specifically teaching providing different current to each needle of the array of deployed needles.
However, Manstein teaches supplying electrical current to specific groups of needles in any desired temporal sequence at different times [0038].
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to provide different current to each needle of the array of needles since Manstein teaches this may help to avoid potential local electrical or thermal interactions among needles that can lead to excessive local damage [0038].
Claims 18, 19, and 21 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Gliklich (2007/0032784) in view of Panescu (2006/0089688), Smith (Patent 4,598,709), and in further view of Cory (Pub. No. US 2008/0039914).
Regarding claim 18, the combination teaches the limitations of claim 16 as previously rejected above. The combination does not teach further comprising measuring electrical resistance of the circuit to determine the depth of the array of needles in the patient’s skin.
However, Cory teaches a needle apparatus capable of measuring the depth of the needle in the tissue of a patient wherein the depth is determined by measuring the resistance of the length of the needle above the skin surface of the patient (Abstract; Para. [0026] [0030]The needle unit may include an electrically resistive layer covering the needle, wherein the resistance of the resistive layer changes with the length of the resistive layer, and an electrical trace from an electrical connector provides a voltage from the voltage source, so as to maintain a constant current, to the electrically resistive layer).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention was made to measure electrical resistance of the circuit since Corey teaches this determines the insertion depth of the needle in the skin of a patient (Para. [0026]).
Regarding claim 19, the combination teaches the limitations of claim 18 as previously rejected above. Cory teaches further comprising providing an indication of said depth to the user (Para. [0057] The needle depth Lb is calculated in step S10 according to equation 2, and displayed in step S12. The calculated value Lb may then be visually displayed on display 141. Those of skill in the art will appreciate that the calculated value Lb may also be audibly displayed and/or may be printed by a printing device attached either directly or indirectly to nerve stimulator 131').
Regarding claim 21, the combination teaches the limitations of claim 18 as previously rejected above. Cory teaches wherein the electrical resistance is measured before and after treatment to determine the level of success of the treatment ([0058] These depth measuring mechanisms allow accurate recording of the needle depth at which an injection was performed and allow for accurate maintenance of needle position during the injection procedure as well as for a period of time after injection when subsequent stimulation attempts are undertaken by the anesthetist; [0055] the resistance measurements for depth determination are collected in a timed fashion).
Claims 22 and 23 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Gliklich (2007/0032784) in view of Panescu (2006/0089688), Smith (Patent 4,598,709), and in further view of O'Brien (Pub. No. 2004/0019350).
Regarding claim 22, the combination teaches the limitations of claim 16 as previously rejected above. The combination does not teach comprising a syringe for supplying the liquids.
However, O’Brien teaches a hollow needle capable of delivering fluid into the skin (26, Fig. 12 Para [0155]) including a syringe pump located on a ram driven by electric motor which acts on the plunger of the syringe to force deliver of the fluid 24 contained therein (Para. [0089]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention was made to include a syringe for injecting fluid into the skin since O'Brien teaches this can provide fluid at a desired flow rate (Para. [0088]).
Regarding claim 23, the combination teaches the limitations of claim 22 as previously rejected above. O’Brien further teaches a motor to control the injection of fluid from the syringe pump (Para. [0089] ram driven by electric motor).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YASAMIN EKRAMI whose telephone number is (571)272-9803. The examiner can normally be reached 9:00-5:00.
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/Y.E/ Examiner, Art Unit 3794
/KAITLYN E SMITH/ Primary Examiner, Art Unit 3794
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