DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
2. Claims 1-10 as originally filed on 06/21/2024 are pending, and have been examined on the merits.
Claim Objections
3. Claims 1, 2, 4, 6, 7, & 9 are objected to because of the following informalities:
a. In claim 1, lines 3-4, the recitation of “a plurality of needle-type electrodes inserted into skin” should instead recite --a plurality of needle-type electrodes configured to be inserted into skin--.
b. In claim 1, lines 3-4, the recitation of “a current intensity corresponding to a present first depth” should instead recite --a current intensity corresponding to a preset first depth--.
c. In claim 1, line 16, the recitation of “from a moment the electrode part is inserted into the skin” should instead recite --from a moment the plurality of electrodes is inserted into the skin--.
d. In claim 1, line 20, the recitation of “from the moment the electrode part is inserted into the skin” should instead recite --from the moment the plurality of electrodes is inserted into the skin--.
e. In claim 2, lines 4-5, the recitation of “until the electrode part is pulled out from the moment the electrode part is inserted into the skin” should instead recite --until the plurality of electrodes is pulled out from the moment the plurality of electrodes is inserted into the skin--.
f. In claim 4, lines 4-5, the recitation of “until the electrode part is pulled out from the moment the electrode part is inserted into the skin” should instead recite --until the plurality of electrodes is pulled out from the moment the plurality of electrodes is inserted into the skin--.
g. In claim 6, line 15, the recitation of “from the moment the electrode part is inserted into the skin” should instead recite --from a moment the plurality of electrodes is inserted into the skin--.
h. In claim 6, line 19, the recitation of “from the moment the electrode part is inserted into the skin” should instead recite --from the moment the plurality of electrodes is inserted into the skin--.
i. In claim 7, lines 4-5, the recitation of “until the electrode part is pulled out from the moment the electrode part is inserted into the skin” should instead recite --until the plurality of electrodes is pulled out from the moment the plurality of electrodes is inserted into the skin--.
j. In claim 9, lines 4-5, the recitation of “until the electrode part is pulled out from the moment the electrode part is inserted into the skin” should instead recite --until the plurality of electrodes is pulled out from the moment the plurality of electrodes is inserted into the skin--.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
4. The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
5. Claims 1-10 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
6. Claim 1 recites the following limitations at lines 14-21:
perform control such that the first current and the second current are sequentially applied to the plurality of electrodes at a current intensity corresponding to a present first depth from a moment the electrode part is inserted into the skin, when the target depth is the first depth, and
perform control such that the second current and the first current are sequentially applied to the plurality of electrodes at a current intensity corresponding to a preset second depth from the moment the electrode part is inserted into the skin when the target depth is the second depth.
Emphasis added.
The above-emphasized claim limitations, which require that the first and second currents be applied “from the moment the electrode part is inserted into the skin” render the claim indefinite, as they contradict the previous recitation in the claim that the processor is “…configured to control the energy supply part such that the first current and the second current are applied…when the plurality of electrodes has reached the target depth” in lines 9-12. As such, it is not clear whether the currents are applied beginning at the moment of insertion, or, when the target depth is reached. As such, one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Clarification is required.
7. Claims 2-5 are rejected as ultimately depending from a claim (claim 1) rejected under 35 U.S.C. 112(b).
8. Claim 6 recites the limitation "the preset first depth" in line 16. There is insufficient antecedent basis for this limitation in the claim.
9. Claim 6 recites the limitation "the preset second depth" in line 20. There is insufficient antecedent basis for this limitation in the claim.
10. Claim 6 recites the following limitations at lines 13-20:
performing control such that the first current and the second current are sequentially applied to the plurality of electrodes at a current intensity corresponding to a first depth from the moment the electrode part is inserted into the skin, when the target depth is the preset first depth; and
performing control such that the first current and the second current are sequentially applied to the plurality of electrodes at a current intensity corresponding to a second depth from the moment the electrode part is inserted into the skin, when the target depth is the preset second depth.
Emphasis added.
The above-emphasized claim limitations, which require that the first and second currents be applied “from the moment the electrode part is inserted into the skin” render the claim indefinite, as they contradict the previous recitation in the claim of “controlling, by the processor of the apparatus, an energy supply part of the apparatus such that a monopolar first current and a bipolar second current are applied… when the plurality of electrodes has reached the target depth” in lines 8-11. As such, it is not clear whether the currents are applied beginning at the moment of insertion, or, when the target depth is reached. As such, one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Clarification is required.
11. Claims 7-10 are rejected as ultimately depending from a claim (claim 6) rejected under 35 U.S.C. 112(b).
Claim Rejections - 35 USC § 103
12. 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.
13. The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
14. Claims 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2021/0339033 to Berube et al. (“Berube”) in view of U.S. Patent Application Publication No. 2010/0049178 to Deem et al. (“Deem”), and further in view of U.S. Patent Application Publication No. 2004/0162551 to Brown et al. ("Brown").
15. Regarding claim 1, and as best understood [see rejection under § 112(b) above], Berube teaches an apparatus for applying [energy] by skin depth during needle insertion, the apparatus comprising:
an electrode part including a plurality of needle-type electrodes inserted into skin [array of RF needles (14) - ¶[0027]; FIGS. 1-2];
an energy supply part [source of radio frequency energy (18) - ¶[0027]; FIG. 2] configured to selectively apply a… first [energy level] and a… second [energy level] to the plurality of electrodes [e.g., ¶’s [0010], [0028], [0035]];
a transfer part [driving unit (20) - ¶[0027] configured to move the electrode part such that the plurality of electrodes reach a target depth in the skin [e.g., ¶’s [0027], [0035]]; and
a processor [controller subsystem (24) - ¶[0028]; FIG. 2] configured to control the energy supply part [(18)] such that the first [energy level] and the second [energy level] are applied to the plurality of electrodes [array (14)] at a [energy level] corresponding to the reached target depth when the plurality of electrodes [array (14)] has reached the target depth [e.g., ¶[0028] (“At each depth, the computer instructions control the source of radio frequency energy to apply the user selected energy level”); ¶[0035] (“The controller subsystem then adjusts the driving unit 20, FIG. 2 to drive the needles 14 to the selected insertion depths, step 50, FIG. 3 and, at each depth, to control the source 18, FIG. 2 to apply the selected energy level at each depth, step 52”)],
wherein the processor [(24)] is configured to:
perform control such that the…[energy level is]… applied to the plurality of electrodes [(14)] at a [energy level]… corresponding to a present [preset] first depth… when the target depth is the first depth [e.g., ¶’s [0010], [0012], [0028], [0035], [0036]], and
perform control such that the… [energy level is]… applied to the plurality of electrodes [(14)] at a [energy level]… corresponding to a preset second depth… when the target depth is the second depth [e.g., ¶’s [0010], [0012], [0028], [0035], [0036]].
A. Sequential Application of Monopolar/Bipolar Current
While, as noted above, Berube teaches that the needle array (14) may be configured to apply RF energy at different energy levels, at different depths, Berube does not teach that monopolar and bipolar currents are sequentially applied, and therefore fails to teach the following emphasized claim limitations:
an apparatus for applying monopolar and bipolar currents by skin depth during needle insertion;
an energy supply part configured to selectively apply a monopolar first current and a bipolar second current to the plurality of electrodes; [and]
wherein the processor [(24)] is configured to:
perform control such that the [monopolar] first current and the [bipolar] second current are sequentially applied to the plurality of electrodes at a current intensity corresponding to a present [preset] first depth…, and
perform control such that the [bipolar] second current and the [monopolar] first current are sequentially applied to the plurality of electrodes at a current intensity corresponding to a preset second depth…
Deem, in a similar field of endeavor, teaches a skin treatment method and apparatus (for reducing sweat production) [¶[0003]], comprising, e.g., an RF delivery device (202) that can take the form of one or more energy delivery elements comprising electrode-tip needles, micro-needles, or stylets for insertion into or across the epidermal layer (102) of the skin [¶[0150]; FIG 10]. Deem further teaches that it was known in the art to apply monopolar energy and bipolar energy selectively, sequentially, and/or simultaneously [see ¶[0145] (“The electrodes can be dynamically assignable or hardwired to facilitate monopolar and/or bipolar energy delivery between any of the electrodes and/or between any of the electrodes and one or more external ground pads. For example, an array of electrodes can be configured such that both a monopolar energy field and a bipolar energy field can be selectively, sequentially, and/or simultaneously delivered. A ground pad can, for example, be attached externally to the patient's skin (e.g., to the patient's leg)”)].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify Berube such that a [monopolar] first current and a [bipolar] second current be sequentially applied to the plurality of electrodes in a desired order at a current intensity corresponding to the depths selected by the user [the first depth and the second depth], since such a particular, known energy delivery technique [used with an RF electrode needle array for penetrating skin in a skin treatment apparatus] was recognized as part of the ordinary capabilities of one skilled in the art, as demonstrated by Deem, and one of ordinary skill in the art would have been capable of applying this known technique to the known device of Berube, and the results [energy delivery via an RF electrode needle array] would have been predictable to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
B. Energy Application at Insertion
Finally, the combination of Berube and Deem, as set for the above, does not teach that energy is applied beginning at the moment of insertion into the skin, and therefore fails to teach the following emphasized claim limitations:
perform control such that the [monopolar] first current and the [bipolar] second current are sequentially applied to the plurality of electrodes at a current intensity corresponding to a present first depth from a moment the electrode part is inserted into the skin, when the target depth is the first depth, and
perform control such that the [bipolar] second current and the [monopolar] first current are sequentially applied to the plurality of electrodes at a current intensity corresponding to a preset second depth from the moment the electrode part is inserted into the skin when the target depth is the second depth.
Brown, in a similar field of endeavor, teaches that it was known, when inserting and removing a needle array from tissue, to apply RF energy to facilitate the insertion and removal processes [see ¶[0072] (“Further, heat and/or RF energy may be applied to the needles during insertion or removal, to facilitate these processes”)].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Berube and Deem such that the RF energy (applied at each depth) be applied from the moment the electrode part is inserted into the skin so as to facilitate insertion, as taught by Brown.
16. Regarding claim 2, the combination of Berube, Deem, & Brown teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
As noted above (in the rejection of claim 1), Brown teaches that it was known, when inserting and removing a needle array from tissue, to apply RF energy to facilitate the insertion and removal processes [see ¶[0072] (“Further, heat and/or RF energy may be applied to the needles during insertion or removal, to facilitate these processes”)].
As such, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Berube, Deem, and Brown such that the processor be configured to perform control such that the first current and the second current are sequentially applied to the plurality of electrodes at the current intensity corresponding to the first depth until the electrode part is pulled out from the moment the electrode part is inserted into the skin when the target depth is the preset first depth, so as to facilitate both insertion and removal of the plurality of needles, as taught by Brown.
17. Regarding claim 3, the combination of Berube, Deem, & Brown teaches all of the limitations of claim 2 for the reasons set forth in detail (above) in the Office Action.
Berube (as modified above to include sequential application of the monopolar first current and the bipolar second current) further teaches wherein the processor is configured to perform control such that there is a predetermined rest period between application times of the first current and the second current [broadly, the period of time it takes for the energy supply part (18) to switch from application of the monopolar first current to the bipolar second current].
18. Regarding claim 4, the combination of Berube, Deem, & Brown teaches all of the limitations of claim 3 for the reasons set forth in detail (above) in the Office Action.
As noted above (in the rejection of claim 1), Brown teaches that it was known, when inserting and removing a needle array from tissue, to apply RF energy to facilitate the insertion and removal processes [see ¶[0072] (“Further, heat and/or RF energy may be applied to the needles during insertion or removal, to facilitate these processes”)].
As such, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Berube, Deem, and Brown such that the processor be configured to perform control such that the second current and the first current are sequentially applied to the plurality of electrodes at the current intensity corresponding to the second depth until the electrode part is pulled out from the moment the electrode part is inserted into the skin when the target depth is the preset second depth, so as to facilitate both insertion and removal of the plurality of needles, as taught by Brown.
19. Regarding claim 5, the combination of Berube, Deem, & Brown teaches all of the limitations of claim 4 for the reasons set forth in detail (above) in the Office Action.
Berube (as modified above to include sequential application of the monopolar first current and the bipolar second current) further teaches wherein the processor is configured to perform control such that there is a predetermined rest period between application times of the second current and the first current [broadly, the period of time it takes for the energy supply part (18) to switch from application of the bipolar second current back to the monopolar first current].
20. Regarding claim 6, Berube teaches a method for being performed by an apparatus for applying [energy] by skin depth during needle insertion, the method comprising:
moving, by a transfer part [driving unit (20) - ¶[0027] of the apparatus, an electrode part of the apparatus such that a plurality of electrodes reach a target depth in skin [array of RF needles (14) - ¶[0027]; see also ¶’s [0010], [0012], [0028], [0035]; FIGS. 1-2];
determining, by a processor [controller subsystem (24) - ¶[0028]; FIG. 2] of the apparatus, whether the plurality of electrodes [array (14)] has reached the target depth [e.g., ¶’s [0035]-[0036]]; and
controlling, by the processor of the apparatus, an energy supply part of the apparatus such that a…first [energy level] and a… second [energy level] are applied to the plurality of electrodes [array (14)] at a [energy level] corresponding to the reached target depth when the plurality of electrodes [array (14)] has reached the target depth [e.g., ¶[0028] (“At each depth, the computer instructions control the source of radio frequency energy to apply the user selected energy level”); ¶[0035] (“The controller subsystem then adjusts the driving unit 20, FIG. 2 to drive the needles 14 to the selected insertion depths, step 50, FIG. 3 and, at each depth, to control the source 18, FIG. 2 to apply the selected energy level at each depth, step 52”)],
wherein the controlling includes:
performing control such that the… [energy level is]… applied to the plurality of electrodes [(14)] at a [energy level] corresponding to a first depth [e.g., ¶’s [0010], [0012], [0028], [0035], [0036]]; and
performing control such that the… [energy level is]… applied to the plurality of electrodes [(14)] at a [energy level] corresponding to a second depth [e.g., ¶’s [0010], [0012], [0028], [0035], [0036]].
A. Sequential Application of Monopolar/Bipolar Current
While, as noted above, Berube teaches that the needle array (14) may be configured to apply RF energy at different energy levels, at different depths, Berube does not teach that monopolar and bipolar currents are sequentially applied, and therefore fails to teach the following emphasized claim limitations:
A method for being performed by an apparatus for applying monopolar and bipolar currents by skin depth during needle insertion;
controlling, by the processor of the apparatus, an energy supply part of the apparatus such that a monopolar first current and a bipolar second current are applied to the plurality of electrodes, [and]
wherein the controlling includes:
performing control such that the first current and the second current are sequentially applied to the plurality of electrodes at a current intensity corresponding to a first depth…; and
performing control such that the first current and the second current are sequentially applied to the plurality of electrodes at a current intensity corresponding to a second depth…
Deem, in a similar field of endeavor, teaches a skin treatment method and apparatus (for reducing sweat production) [¶[0003]], comprising, e.g., an RF delivery device (202) that can take the form of one or more energy delivery elements comprising electrode-tip needles, micro-needles, or stylets for insertion into or across the epidermal layer (102) of the skin [¶[0150]; FIG 10]. Deem further teaches that it was known in the art to apply monopolar energy and bipolar energy selectively, sequentially, and/or simultaneously [see ¶[0145] (“The electrodes can be dynamically assignable or hardwired to facilitate monopolar and/or bipolar energy delivery between any of the electrodes and/or between any of the electrodes and one or more external ground pads. For example, an array of electrodes can be configured such that both a monopolar energy field and a bipolar energy field can be selectively, sequentially, and/or simultaneously delivered. A ground pad can, for example, be attached externally to the patient's skin (e.g., to the patient's leg)”)].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify Berube such that a [monopolar] first current and a [bipolar] second current be sequentially applied to the plurality of electrodes in a desired order at a current intensity corresponding to the depths selected by the user [the first depth and the second depth], since such a particular, known energy delivery technique [used with an RF electrode needle array for penetrating skin in a skin treatment apparatus] was recognized as part of the ordinary capabilities of one skilled in the art, as demonstrated by Deem, and one of ordinary skill in the art would have been capable of applying this known technique to the known method of Berube, and the results [energy delivery via an RF electrode needle array] would have been predictable to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
B. Energy Application at Insertion
Finally, the combination of Berube and Deem, as set for the above, does not teach that energy is applied beginning at the moment of insertion into the skin, and therefore fails to teach the following emphasized claim limitations:
performing control such that the [monopolar] first current and the [bipolar] second current are sequentially applied to the plurality of electrodes at a current intensity corresponding to a first depth from the moment the electrode part is inserted into the skin, when the target depth is the preset first depth; and
performing control such that the [monopolar] first current and the [bipolar] second current are sequentially applied to the plurality of electrodes at a current intensity corresponding to a second depth from the moment the electrode part is inserted into the skin, when the target depth is the preset second depth.
Brown, in a similar field of endeavor, teaches that it was known, when inserting and removing a needle array from tissue, to apply RF energy to facilitate the insertion and removal processes [see ¶[0072] (“Further, heat and/or RF energy may be applied to the needles during insertion or removal, to facilitate these processes”)].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Berube and Deem such that the RF energy (applied at each depth) be applied from the moment the electrode part is inserted into the skin so as to facilitate insertion, as taught by Brown.
21. Regarding claim 7, the combination of Berube, Deem, & Brown teaches all of the limitations of claim 6 for the reasons set forth in detail (above) in the Office Action.
As noted above (in the rejection of claim 6), Brown teaches that it was known, when inserting and removing a needle array from tissue, to apply RF energy to facilitate the insertion and removal processes [see ¶[0072] (“Further, heat and/or RF energy may be applied to the needles during insertion or removal, to facilitate these processes”)].
As such, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Berube, Deem, and Brown such that the processor be configured to perform control such that the first current and the second current are sequentially applied to the plurality of electrodes at the current intensity corresponding to the first depth until the electrode part is pulled out from the moment the electrode part is inserted into the skin when the target depth is the preset first depth, so as to facilitate both insertion and removal of the plurality of needles, as taught by Brown.
22. Regarding claim 8, the combination of Berube, Deem, & Brown teaches all of the limitations of claim 7 for the reasons set forth in detail (above) in the Office Action.
Berube (as modified above to include sequential application of the monopolar first current and the bipolar second current) further teaches wherein the controlling includes performing control such that there is a predetermined rest period between application times of the first current and the second current [broadly, the period of time it takes for the energy supply part (18) to switch from application of the monopolar first current to the bipolar second current].
23. Regarding claim 9, the combination of Berube, Deem, & Brown teaches all of the limitations of claim 8 for the reasons set forth in detail (above) in the Office Action.
As noted above (in the rejection of claim 6), Brown teaches that it was known, when inserting and removing a needle array from tissue, to apply RF energy to facilitate the insertion and removal processes [see ¶[0072] (“Further, heat and/or RF energy may be applied to the needles during insertion or removal, to facilitate these processes”)].
As such, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Berube, Deem, and Brown such that the controlling includes performing control such that the second current and the first current are sequentially applied to the plurality of electrodes at the current intensity corresponding to the second depth until the electrode part is pulled out from the moment the electrode part is inserted into the skin when the target depth is the preset second depth, so as to facilitate both insertion and removal of the plurality of needles, as taught by Brown.
24. Regarding claim 10, the combination of Berube, Deem, & Brown teaches all of the limitations of claim 9 for the reasons set forth in detail (above) in the Office Action.
Berube (as modified above to include sequential application of the monopolar first current and the bipolar second current) further teaches wherein the controlling includes performing control such that there is a predetermined rest period between application times of the second current and the first current [broadly, the period of time it takes for the energy supply part (18) to switch from application of the bipolar second current back to the monopolar first current].
Conclusion
25. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Bradford C. Blaise whose telephone number is (571)272-5617. The examiner can normally be reached on Monday - Friday 8 AM-5 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Linda Dvorak can be reached on 571-272-4764. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Bradford C. Blaise/Examiner, Art Unit 3794