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 Objections
Claims 22, 39, and 42 are objected to because of the following informalities:
In claim 1, lines 3-4, “a depth of 0.5mm to 3.5mm” should read “a depth of 0.5 mm to 3.5 mm”.
In claim 39, line 2, “one or more predefined physical property” should read “one or more predefined physical properties”.
In claim 42, line 2, “target area iwthn the dermis” should read “target area within the dermis”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 22-44 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “suitable” in claim 22 is a relative term which renders the claim indefinite. The term “suitable” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Therefore, it is unclear if the one or more microneedles can percutaneously penetrate the skin to a depth of 0.5mm to 3.5mm, or if they can penetrate the skin to another depth value or range.
Claim 22 recites the limitation "the treatment" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 22 recites the limitation "the neurovascular plexus" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 22 recites the limitation "the skin" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 23 recites the limitation "the dermis layer" in line 2. There is insufficient antecedent basis for this limitation in the claim.
The term “preferably” in claim 29 is a relative term which renders the claim indefinite. The term “preferably” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Therefore, it is unclear as to what total RF energy the apparatus is configured to provide.
Claim 31 recites the limitation "the tips" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 37 recites the limitation "the basis" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 37 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. It is unclear what the Applicant means by “a member selected from setting”. The examiner was unsure if this was a typo, and did not have a suggestion for how to correct said limitation (hence why there is a rejection and not objection for said claim). It is recommended that the Applicant amend this limitation to be grammatically correct, or delete said limitation.
Claim 39 recites the limitation "the patient" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 42, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 43-44 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claims do not fall within at least one of the four categories of patent eligible subject matter because the broadest reasonable interpretation of “a computer program product” in claim 43 and “a computer-readable data carrier” in claim 44 encompass signals per se. The specification does not provide a special definition of a computer program product or a computer-readable data carrier. As understood in light of the specification, the broadest reasonable interpretation of claims 43-44 encompass signals, which are not within one of the four statutory categories of invention. See MPEP 2106.03(I). It is suggested that claim 43 be amended to recite a “non-transitory” computer program product to overcome this rejection. It is also suggested that claim 44 be amended to recite a “non-transitory” computer-readable data carrier to overcome this rejection.
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.
Claims 22-39 and 41-44 are rejected under 35 U.S.C. 103 as being unpatentable over Wooten (U.S. PGPub No. 2022/0054189) in view of Varshavsky et al. (U.S. PGPub No. 2022/0387092).
Regarding claim 22, Wooten teaches a microneedling apparatus (Fig. 1,
Paragraph 0073, line 6, 100) for use in the treatment of dysfunctions of intracutaneous nerve fibers and/or the neurovascular plexus comprising: one or more microneedles (2) (Fig. 1, Paragraph 0074, lines 9-11, 112) suitable for percutaneous penetration of the skin (Paragraph 0074, lines 13-14) to a depth of 0.5mm to 3.5mm (Paragraph 0074, lines 36-38); and means to provide radiofrequency (RF) energy (Paragraph 0077, lines 1-3).
In addition to structural limitations, claim 22 recites functional limitations drawn toward the intended use or manner of operating the claimed apparatus. The functional limitations are: “for use in the treatment of dysfunctions of intracutaneous nerve fibers and/or the neurovascular plexus.” When the cited prior art teaches all of the positively recited structure of the claimed apparatus, it will be held that the prior art apparatus is capable of performing all of the claimed functional limitations of the claimed apparatus. The courts have held that: (1) "apparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990), and (2) a claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). MPEP § 2111.02 and 2114.
Wooten does not teach that the microneedling apparatus includes a means to
provide radiofrequency energy suitable for providing 5 mJ to 60 mJ per microneedle. Varshavsky, however, teaches a microneedling apparatus (Fig. 1, Paragraph 0035, lines 1-2, 10) that comprises one or more microneedles (Fig. 2, Paragraph 0041, line 1, 34) and a means to provide radiofrequency energy (Paragraph 0050, lines 1-2). Varshavsky also teaches that the RF generator can provide 10 to 82 mJ of RF energy per microneedle (Paragraph 0050, lines 3-6).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Wooten in view of Varshavsky to include that the apparatus comprises a means to provide radiofrequency energy suitable for providing 5 mJ to 60 mJ per microneedle. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of “about 1-5%” while the claim was limited to “more than 5%.” The court held that “about 1-5%” allowed for concentrations slightly above 5% thus the ranges overlapped.) MPEP § 2144.05-I.
Regarding claim 23, Wooten teaches the apparatus (Fig. 1, Paragraph 0073, line 6, 100) of claim 22, wherein the apparatus is configured for applying RF energy (Paragraph 0077, lines 1-3) to a target area (Paragraph 0106, lines 21-22) within the dermis layer (D) of the skin (Paragraph 0077, lines 9-10) through the one or more microneedles (2) (Fig. 1, Paragraph 0074, lines 9-11, 112).
Wooten does not teach that the apparatus is configured for applying RF energy of 5 mJ to 60 mJ per microneedle. Varshavsky, however, teaches a microneedling apparatus (Fig. 1, Paragraph 0035, lines 1-2, 10) that comprises one or more microneedles (Fig. 2, Paragraph 0041, line 1, 34) and a means to provide RF energy (Paragraph 0050, lines 1-2). Varshavsky also teaches that the RF generator can provide 10 to 82 mJ of RF energy per microneedle (Paragraph 0050, lines 3-6).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Wooten in view of Varshavsky to include that the apparatus is configured for applying RF energy of 5 mJ to 60 mJ per microneedle. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of “about 1-5%” while the claim was limited to “more than 5%.” The court held that “about 1-5%” allowed for concentrations slightly above 5% thus the ranges overlapped.) MPEP § 2144.05-I.
Regarding claim 24, Wooten teaches the apparatus (Fig. 1, Paragraph 0073, line 6, 100) of claim 23, wherein the apparatus is configured for applying RF energy (Paragraph 0077, lines 1-3). Wooten does not teach that the apparatus is configured for applying RF of 10 mJ to 40 mJ per microneedle. Varshavsky, however, teaches a microneedling apparatus (Fig. 1, Paragraph 0035, lines 1-2, 10) that comprises one or more microneedles (Fig. 2, Paragraph 0041, line 1, 34) and a means to provide RF energy (Paragraph 0050, lines 1-2). Varshavsky also teaches that the RF generator can provide 10 to 82 mJ of RF energy per microneedle (Paragraph 0050, lines 3-6).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Wooten in view of Varshavsky to include that the apparatus is configured for applying RF of 10 mJ to 40 mJ per microneedle. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of “about 1-5%” while the claim was limited to “more than 5%.” The court held that “about 1-5%” allowed for concentrations slightly above 5% thus the ranges overlapped.) MPEP § 2144.05-I.
Regarding claim 25, Wooten teaches the apparatus (Fig. 1, Paragraph 0073, line 6, 100) of claim 23, wherein the apparatus is configured for providing RF energy pulses (Paragraph 0078, lines 11-14) having a pulse duration of 1 millisecond to 1000 milliseconds (Paragraph 0078, lines 14-16).
In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of “about 1-5%” while the claim was limited to “more than 5%.” The court held that “about 1-5%” allowed for concentrations slightly above 5% thus the ranges overlapped.) MPEP § 2144.05-I.
Regarding claim 26, Wooten in view of Varshavsky discloses the claimed invention of claim 25. Wooten further discloses the apparatus (Fig. 1, Paragraph 0073, line 6, 100) of claim 25, wherein the apparatus is configured for providing RF energy pulses (Paragraph 0078, lines 11-14) having a pulse duration of 100 milliseconds to 500 milliseconds (Paragraph 0078, lines 14-16).
Regarding claim 27, Wooten teaches the apparatus (Fig. 1, Paragraph 0073, line 6, 100) of claim 23, wherein the apparatus is configured to provide RF energy pulses (Paragraph 0078, lines 11-14) at a frequency of 200 kHz to 800 kHz (Paragraph 0081, lines 6-8).
In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of “about 1-5%” while the claim was limited to “more than 5%.” The court held that “about 1-5%” allowed for concentrations slightly above 5% thus the ranges overlapped.) MPEP § 2144.05-I.
Regarding claim 28, Wooten teaches the apparatus (Fig. 1, Paragraph 0073, line 6, 100) of claim 27, wherein the apparatus is configured to provide RF energy pulses (Paragraph 0078, lines 11-14) at a frequency of 500 kHz to 700 kHz (Paragraph 0081, lines 6-8).
In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of “about 1-5%” while the claim was limited to “more than 5%.” The court held that “about 1-5%” allowed for concentrations slightly above 5% thus the ranges overlapped.) MPEP § 2144.05-I.
Regarding claim 29, Wooten teaches the claimed invention except for the apparatus being configured to provide a total RF energy of preferably 1 J to 100 J per 5 cm2 of target area. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include that the apparatus is configured to provide a total RF energy of preferably 1 J to 100 J per 5 cm2 of target area, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges [ or optimum value ] involves only routine skill in the art. In re Aller, 105 USPQ 233. MPEP 2144.05-II-A.
Furthermore, since applicants have not disclosed that these modifications solve any stated problem or are for any particular purpose and it appears that the device would perform equally well with either design, these modifications are a matter of design choice. Absent a teaching as to criticality of the apparatus being configured to provide a total RF energy of preferably 1 J to 100 J per 5 cm2 of target area (See Paragraph 0093 of Applicant’s Specification), this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975). MPEP 2144.05.
Regarding claim 30, Wooten teaches the claimed invention except for the apparatus being configured to provide a total RF energy of 15 J to 50 J per 5 cm2 of target area. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include that the apparatus is configured to provide a total RF energy of 15 J to 50 J per 5 cm2 of target area, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges [ or optimum value ] involves only routine skill in the art. In re Aller, 105 USPQ 233. MPEP 2144.05-II-A.
Furthermore, since applicants have not disclosed that these modifications solve any stated problem or are for any particular purpose and it appears that the device would perform equally well with either design, these modifications are a matter of design choice. Absent a teaching as to criticality of the apparatus being configured to provide a total RF energy of 15 J to 50 J per 5 cm2 of target area (See Paragraph 0093 of Applicant’s Specification), this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975). MPEP 2144.05.
Regarding claim 31, Wooten in view of Varshavsky discloses the claimed invention of claim 22. Wooten further discloses the apparatus (Fig. 1, Paragraph 0073, line 6, 100) of claim 22, wherein the apparatus is configured to provide RF energy (Paragraph 0077, lines 1-3) exclusively through the tips (Paragraph 0077, lines 49-55) of the one or more microneedles (2) (Fig. 1, Paragraph 0074, lines 9-11, 112).
Regarding claim 32, Wooten in view of Varshavsky discloses the claimed invention of claim 22. Wooten further discloses the apparatus (Fig. 1, Paragraph 0073, line 6, 100) of claim 22, comprising a plurality of microneedles (2) (Fig. 1, Paragraph 0074, lines 9-11, 112) for delivering bipolar RF (Paragraph 0077, lines 32-37) to a target area (Paragraph 0106, lines 21-22) in the dermis of the skin (Paragraph 0077, lines 9-10).
Regarding claim 33, Wooten in view of Varshavsky discloses the claimed invention of claim 32. Wooten further discloses the apparatus (Fig. 1, Paragraph 0073, line 6, 100) of claim 32, the plurality of microneedles (2) comprising 2 to 100 microneedles (Fig. 1, Paragraph 0074, lines 9-11, 112).
Regarding claim 34, Wooten in view of Varshavsky discloses the claimed invention of claim 22. Wooten further discloses the apparatus (Fig. 1, Paragraph 0073, line 6, 100) of claim 22, wherein the apparatus further comprises a processor (Paragraph 0083, lines 1-2) and/or is communicatively connected to a processor (Paragraph 0083, lines 12-14).
Regarding claim 35, Wooten in view of Varshavsky discloses the claimed invention of claim 22. Wooten further discloses the apparatus (Fig. 1, Paragraph 0073, line 6, 100) of claim 22, wherein the apparatus is configured for receiving impedance values for a target area in the dermis (Paragraph 0089, lines 1-15); and for automatically regulating provided RF energy (Paragraph 0084, lines 2-4 and 6-11) to adjust RF energy provided to said target area according to a measured impedance value for said target area (Paragraph 0212, lines 1-3).
Regarding claim 36, Wooten in view of Varshavsky discloses the claimed invention of claim 35. Wooten further discloses the apparatus (Fig. 1, Paragraph 0073, line 6, 100) of claim 35, wherein the apparatus is configured for receiving impedance measurements (Paragraph 0089, lines 1-15) in real time (Paragraph 0212, line 3) and for regulating the provided RF energy automatically in real time (Paragraph 0084, lines 2-4 and 6-11).
Regarding claim 37, Wooten in view of Varshavsky discloses the claimed invention of claim 22. Wooten further discloses the apparatus (Fig. 1, Paragraph 0073, line 6, 100) of claim 22, wherein the apparatus is configured for receiving patient-relevant input information (Paragraph 0082, lines 1-4 and 21-22); and for a member selected from setting and/or adjusting penetration depths of the one or more microneedles, RF energy provided, RF pulse duration, and/or RF frequency (Paragraph 0084, lines 8-11) on the basis of said patient-relevant information (Paragraph 0082, lines 3-6).
Regarding claim 38, Wooten in view of Varshavsky discloses the claimed invention of claim 22. Wooten further discloses the apparatus (Fig. 1, Paragraph 0073, line 6, 100) of claim 22, wherein the apparatus is adapted to be pre-programmed (Paragraph 0083, lines 14-16) with a defined provided RF energy (Paragraph 0078, lines 20-23), RF pulse duration (Paragraph 0078, lines 14-16), and/or RF frequency (Paragraph 0081, lines 6-8) on the basis of a predefined condition (Paragraph 0083, lines 14-16 and Paragraph 0106, lines 8-10).
Regarding claim 39, Wooten in view of Varshavsky discloses the claimed invention of claim 38. Wooten further discloses the apparatus (Fig. 1, Paragraph 0073, line 6, 100) of claim 38, wherein the predefined condition (Paragraph 0083, lines 14-16 and Paragraph 0106, lines 8-10) is selected from a predefined headache condition, and/or one or more predefined physical property of the patient (Paragraph 0106, lines 8-10).
Regarding claim 41, Wooten teaches a method (Paragraph 0062, lines 9-11) for controlling (Paragraph 0082, lines 28-30) and/or adapting (Paragraph 0082, lines 3-6) the microneedling apparatus (Fig. 1, Paragraph 0073, line 6, 100) of claim 22, comprising: setting a defined percutaneous penetration depth (Paragraph 0074, line 36) for the one or more microneedles (Fig. 1, Paragraph 0074, lines 9-11, 112) ranging from 0.5 mm to 3.5 mm (Paragraph 0074, lines 36-38); and setting an RF energy output value (Paragraph 0109, lines 5-7) for applying RF energy through the one or more microneedles (Paragraph 0077, lines 1-3).
Wooten does not teach that the method includes setting an RF energy output value of 5 mJ to 60 mJ per microneedle. Varshavsky, however, teaches a microneedling apparatus (Fig. 1, Paragraph 0035, lines 1-2, 10) that comprises one or more microneedles (Fig. 2, Paragraph 0041, line 1, 34) and a means to provide RF energy (Paragraph 0050, lines 1-2). Varshavsky also teaches that the RF generator can provide 10 to 82 mJ of RF energy per microneedle (Paragraph 0050, lines 3-6).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Wooten in view of Varshavsky to specify that the method includes setting an RF energy output value of 5 mJ to 60 mJ per microneedle. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of “about 1-5%” while the claim was limited to “more than 5%.” The court held that “about 1-5%” allowed for concentrations slightly above 5% thus the ranges overlapped.) MPEP § 2144.05-I.
Regarding claim 42, Wooten in view of Varshavsky discloses the claimed invention of claim 41. Wooten further discloses the method (Paragraph 0062, lines 9-11) of claim 41, further comprising: receiving impedance values for a target area iwithn the dermis (Paragraph 0089, lines 1-15); and parametrizing the apparatus to suggest a value of RF energy output (Paragraph 0085, lines 22-25), or to automatically regulate RF energy output (Paragraph 0084, lines 2-4 and 6-11), such as to adjust RF energy delivered to the target area according to a measured impedance value for said area (Paragraph 0212, lines 1-3).
Regarding claim 43, Wooten teaches a computer program product (Paragraph 0083, lines 6-7) which contains instructions (Paragraph 0083, line 14) for controlling (Paragraph 0082, lines 28-30) and/or adapting (Paragraph 0082, lines 3-6) the microneedling apparatus (Fig. 1, Paragraph 0073, line 6, 100) of claim 22 and which, when loaded on a computerized system (Paragraph 0083, line 11) or on a processor (Paragraph 0083, lines 1-2) of said apparatus, causes the apparatus to perform the steps of: setting a defined percutaneous penetration depth (Paragraph 0074, line 36) for the one or more microneedles (Fig. 1, Paragraph 0074, lines 9-11, 112) ranging from 0.5 mm to 3.5 mm (Paragraph 0074, lines 36-38); and setting an RF energy output value (Paragraph 0109, lines 5-7) for applying RF energy through the one or more microneedles (Paragraph 0077, lines 1-3).
Wooten does not teach that the computer program product causes the apparatus to set an RF energy output value of 5 mJ to 60 mJ per microneedle. Varshavsky, however, teaches a microneedling apparatus (Fig. 1, Paragraph 0035, lines 1-2, 10) that comprises one or more microneedles (Fig. 2, Paragraph 0041, line 1, 34) and a means to provide RF energy (Paragraph 0050, lines 1-2). Varshavsky also teaches that the RF generator can provide 10 to 82 mJ of RF energy per microneedle (Paragraph 0050, lines 3-6).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Wooten in view of Varshavsky to include that the computer program product causes the apparatus to set an RF energy output value of 5 mJ to 60 mJ per microneedle. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of “about 1-5%” while the claim was limited to “more than 5%.” The court held that “about 1-5%” allowed for concentrations slightly above 5% thus the ranges overlapped.) MPEP § 2144.05-I.
Regarding claim 44, Wooten teaches a computer-readable data carrier (Paragraph 0083, lines 1-2) comprising instructions (Paragraph 0083, line 14) which, when executed by an external processor (Paragraph 0083, line 11) or by a processor (Paragraph 0083, lines 1-2) of the apparatus (Fig. 1, Paragraph 0073, line 6, 100) of claim 22, cause the apparatus to carry out the steps of: setting a defined percutaneous penetration depth (Paragraph 0074, line 36) for the one or more microneedles (2) (Fig. 1, Paragraph 0074, lines 9-11, 112) ranging from 0.5 mm to 3.5 mm (Paragraph 0074, lines 36-38); and setting an RF energy output value (Paragraph 0109, lines 5-7) for applying RF energy through the one or more microneedles (2) (Paragraph 0077, lines 1-3).
Wooten does not teach that the computer-readable data carrier comprises instructions that cause the apparatus to set an RF energy output value of 5 mJ to 60 mJ per microneedle. Varshavsky, however, teaches a microneedling apparatus (Fig. 1, Paragraph 0035, lines 1-2, 10) that comprises one or more microneedles (Fig. 2, Paragraph 0041, line 1, 34) and a means to provide RF energy (Paragraph 0050, lines 1-2). Varshavsky also teaches that the RF generator can provide 10 to 82 mJ of RF energy per microneedle (Paragraph 0050, lines 3-6).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Wooten in view of Varshavsky to include that the computer-readable data carrier comprises instructions that cause the apparatus to set an RF energy output value of 5 mJ to 60 mJ per microneedle. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of “about 1-5%” while the claim was limited to “more than 5%.” The court held that “about 1-5%” allowed for concentrations slightly above 5% thus the ranges overlapped.) MPEP § 2144.05-I.
Claim 40 is rejected under 35 U.S.C. 103 as being unpatentable over Wooten (U.S. PGPub No. 2022/0054189) in view of Varshavsky et al. (U.S. PGPub No. 2022/0387092) as applied to claim 22 above, and further in view of JP-2017523015 (herein referred to as JP2017).
Regarding claim 40, Wooten teaches the apparatus (Fig. 1, Paragraph 0073, line 6, 100) of claim 22. Wooten does not teach that the dysfunction of intracutaneous nerve fibers and/or the neurovascular plexus is selected from a group consisting of headache disorders, trigeminal neuralgia, allodynia, a metabolic neuropathy, an autoimmune neuropathy, a spontaneous neuropathy, an iatrogenic neuropathy, alopecia, erectile dysfunction, and a dysfunction associated with a viral infection.
JP2017, however, teaches an apparatus for use in the treatment of dysfunctions of intracutaneous nerve fibers (Paragraph 0068, lines 1-2 and Paragraph 0074, lines 5-7) that comprises one or more microneedles (Paragraph 0050, line 2, 154) suitable for percutaneous penetration of the skin (Paragraph 0021, lines 1-2), and a means to provide radiofrequency (RF) energy through the microneedles (Paragraph 0053, lines 1-2).
Furthermore, JP2017 teaches that the dysfunction of intracutaneous nerve fibers is selected from a group consisting of headache disorders (Paragraph 0023, line 20), neuropathy (Paragraph 0070, line 3), analgesia (Paragraph 0070, line 3), and erectile dysfunction (Paragraph 0077, lines 1-3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wooten to incorporate the teachings of JP2017 to include that the dysfunction of intracutaneous nerve fibers can be headache disorders, neuropathy, and erectile dysfunction. Doing so would ensure that a variety of conditions can be treated with said apparatus by providing stimulation to a target nerve (Paragraph 0010, lines 1-3), as recognized by JP2017.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Wooten et al. (WIPO Pub. No. 2020/086552) discloses a microneedling system (100) that comprises a handpiece (102), one or more microneedles (112), and a means for applying radiofrequency (RF) energy (Paragraph 0031) to a target area (Paragraph 0054) within the dermis layer of the skin of a patient (Paragraph 0031).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Heidi Hilsmier whose telephone number is (571)272-2984. The examiner can normally be reached Monday - Fridays from 7:30 AM - 3:30 PM.
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/H.A.H./Patent Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796
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