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 .
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.
Information Disclosure Statement
2. The Information Disclosure Statements filed on 14 July 2024 and 26 December 2024 have been considered by the Examiner.
Claim Rejections - 35 USC § 112
3. 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 and 29 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.
Claim 22 recites the limitation "the distal end portion" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 29 recites the limitation "the distal end portion" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
4. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
5. Claims 20-33 are rejected under 35 U.S.C. 102 (a) (1) and (a) (2) as being anticipated by Ko et al. (US 2019/0059992 A1).
Regarding claims 20 and 27, Ko teaches an apparatus and a method for treatment of skin tissue of a patient ([0007, 0014]), the apparatus comprising:
an energy source (the RF generator 130 includes RF generation modules 131-133 [0041-0042]);
an electrode array of at least one first electrode and at least one second electrode connected to the energy source (the RF generator 130 includes RF generation modules 131-133 which can be connected to the respective electrodes modules 221, 222, and 223 [0040-0043]);
the electrode array configured to apply, an initial electrical energy from the energy source to a stratum corneum of a multilayer skin tissue site to target the stratum corneum to reduce its impedance; and a treatment electrical energy from the energy source to the skin layers of the multilayer skin tissue site to cause thermal damage below the stratum corneum (Applicant recites in 3 types of stimulation treatments in claims 21 and 28 that would cause a reduced impedance and thermal damage below the stratum corneum. Specifically, Applicant recites the treatments to comprise at least one of the following (i) a low energy total usage, for the initial electrical energy, followed by a high total energy usage, for the treatment electrical energy; (ii) a shorter duration, for the initial electrical energy, followed by a longer duration, for the treatment electrical energy; or (iii) a high peak energy, for the initial electrical energy, followed by a low peak energy, for the treatment electrical energy. Similarly, Ko teaches a shorter duration for the first mode (e.g., initial electrical energy) and a longer duration for the second mode (e.g., treatment electrical energy) [0009, claim 4]. Alternatively, Ko teaches a high peak energy for the first mode (e.g., initial electrical energy) and a low peak energy for the second mode (e.g., treatment electrical energy) [0009, claim 4]. Thus, the Examiner respectfully submits that Ko applies the same initial and treatment energy as described in Applicant’s claim 21 and 28 which would cause a reduction in impedance of the stratum corneum and thermal damage below the stratum corneum [0004, 0009]. Lastly, Ko discloses that RF energy will provide heat or thermal effects on the layers of the skin tissue [0004, 0006, 0009]).
Regarding claims 21 and 28, Ko teaches wherein combination of the initial electrical energy and the treatment electrical energy comprises at least one of the following:
(ii) a shorter duration, for the initial electrical energy, followed by a longer duration, for the treatment electrical energy (Ko teaches a shorter duration for the first mode (e.g., initial electrical energy) and a longer duration for the second mode (e.g., treatment electrical energy) [0009, claim 4]); or
(iii) a high peak energy, for the initial electrical energy, followed by a low peak energy, for the treatment electrical energy (Ko teaches a high peak energy for the first mode (e.g., initial electrical energy) and a low peak energy for the second mode (e.g., treatment electrical energy) [0009, claim 4]).
Regarding claims 22 and 29, Ko teaches wherein the at least one first electrode and the at least one second electrode are arranged in at least one of the following:
(iii) form a slight elevation above the distal end portion (figure 4 illustrates the first electrode module 221 and the second electrode module 222 protruding from the distal support plate 351 [0041, FIG. 4]).
Regarding claims 23 and 30, Ko teaches wherein the at least one second electrode surrounds the at least one first electrode with a gap therebetween (figure 4 illustrates the second electrode module 222 consist of electrodes 222a and 222b which surround the first electrode module 221 with a gap therebetween [0041, FIG. 4]).
Regarding claims 24 and 31, Ko teaches wherein at least one second electrode is one single second electrode substantially extending over a distal end portion of a handpiece (figure 4 illustrates the second electrode module 222 protruding from the distal support plate 351 of the handpiece housing 210 [0032, 0041, FIG. 4]).
Regarding claims 25 and 32, Ko teaches wherein the at least one first electrode is a plurality of first electrodes arranged in at least one of the following arrangements:
(ii) a plurality of rows (figure 4 illustrates the first electrode module 221 consist of a plurality of first electrodes 221a-221b that are arranged in rows [FIG. 4]).
Regarding claims 26 and 33, Ko teaches wherein the at least one first electrode is in a form of a pin protruding distally with respect to a distal end portion of the apparatus (figure 4 illustrates the first electrode module 221 consisting of electrodes 221a-221b that are in the form of a pin protruding from the distal support plate 351 [0041, FIG. 4]).
Double Patenting
6. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
7. Claims 20-33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 and 9-15 of U.S. Patent No. 12,064,623 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims recite an apparatus for treatment of skin tissue. Specifically, both sets of claims recite the apparatus comprising an energy source, a first electrode, and a second electrode. Furthermore, both sets of claims recite the electrode array (e.g., first and second electrodes) being configured to apply an initial electrical energy or first pulse from the energy source to a stratum corneum of a multilayer skin tissue site to target the stratum corneum to reduce its impedance. Lastly, both sets of claims recite the electrode array (e.g., first and second electrodes) being configured to apply a treatment electrical energy or second pulse from the energy source to the skin layers of the multiplayer skin tissue site to cause thermal damage below the stratum corneum.
Although not exhaustive, a brief matching of the pending claims to those of U.S. Patent No. 12,064,623 B2 is provided below.
Application No. 18/772,206
U.S. Patent No. 12,064,623 B2
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Statement on Communication via Internet
8. Communications via Internet email are at the discretion of the applicant. All Internet communications between USPTO employees and applicants must be made using USPTO tools.
Without a written authorization by applicant in place, the USPTO will not respond via Internet email to any Internet correspondence which contains information subject to the confidentiality requirement as set forth in 35 U.S.C. 122. A paper copy of such correspondence and response will be placed in the appropriate patent application. Except for correspondence that only sets up an interview time, all correspondence between the Office and the applicant including applicant's representative must be placed in the appropriate patent application. If an email contains any information beyond scheduling an interview such as an interview agenda or authorization, it must be placed in the application.
For those applications where applicant wishes to communicate with the examiner via Internet communications, e.g., email or video conferencing tools, the following is a sample authorization form which may be used by applicant:
"Recognizing that Internet communications are not secure, I hereby authorize the USPTO to communicate with the undersigned and practitioners in accordance with 37 CFR 1.33 and 37 CFR 1.34 concerning any subject matter of this application by video conferencing, instant messaging, or electronic mail. I understand that a copy of these communications will be made of record in the application file."
Please refer to MPEP 502.03 for guidance on Communications via Internet.
Conclusion
9. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSHUA BRENDON SOLOMON whose telephone number is (571)270-7208. The examiner can normally be reached on 7:30am -4:30pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Niketa Patel can be reached on (571)272-4156. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSHUA BRENDON SOLOMON/Examiner, Art Unit 3792