Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 102
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 –
Claims 1-3, 6, 8 10-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Francischelli et al (2012/0123400).
Regarding claim 1, Francischelli et al disclose an RF medical apparatus comprising an RF generator to generate a test pulse for detecting the characteristics of skin tissue. See, for example, paragraph [0071] which discusses the delivery of a low amplitude test pulse (46). The test pulse is monitored by a monitoring unit to detect a change in information on state of tissue (e.g. impedance) while the test pulse is transmitted. See Figure 3 which shows the change in impedance (48) and temperature in response to the test pulse (46). Francischelli et al further disclose an estimating unit (Figure 4) which determines the characteristics of tissue based on an impedance pattern (48). See, also, paragraph [0075].
Regarding claim 2, the estimating unit determines the characteristics of tissue by comparing the monitored value with reference data stored in the estimating unit. See paragraphs [0077-0081] which discusses comparing the impedance curve measured during the test pulse to stored curves to determine tissue characteristics. Regarding claim 3, the curve (48 – Figure 3) is monitored over time during the application of the pulse. Regarding claim 6, see Figure 3 which shows a predetermined pattern and pulse duration that is terminated at a designated time point. Regarding claim 8, see again Figure 3 which shows the change in impedance over the duration of the pulse and the discussion at paragraphs [0077-0081] which discusses determining the tissue characteristics based on the time of the impedance curve. Regarding claim 10, the monitoring unit also measure temperature during the test pulse (Figure 3).
Regarding claim 11, Francischelli et al provide an RF medical apparatus comprising an RF generator to generate a test pulse (para. [0071] and Figure 3 as addressed above), a monitoring unit to monitor information on a state of tissue (e.g. impedance) while the test pulse is transmitted and as estimating unit as discussed at paragraph [0077-0081] as addressed above. The results of the estimating unit are fed to a control unit (e.g. processor 72) which sets initial parameters for the treatment pulse, and the state of tissue (e.g. temperature and impedance) is monitored during treatment as well. See, for example, paragraph [0086].
Regarding claim 12, Francischelli et al provide a method of examining tissue comprising transmitting a test pulse to a target site, monitoring information on a state of the tissue (e.g. impedance) and determining characteristics of the tissue based on the impedance pattern over time (Figure 3, for example) by a monitoring unit while the test pulse is transmitted. See discussion of claim 1 as well.
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.
Claims 4, 5, 7, 9 and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Francischelli et al (‘400) in view of the teaching of Wham et al (2004/0193148).
Francischelli et al disclose the apparatus and method of determining tissue characteristics based on a time rate of change of the tissue (i.e. impedance) over the duration of a test pulse as addressed previously. Francischelli et al disclose a memory that stores various different impedance curves for different tissue characteristics (e.g. thickness and blood flow as per para. [0079]), but fail to expressly disclose a consideration of water content.
Wham et al disclose another RF treatment system that utilizes a test pulse to determine tissue characteristics, which characteristics are then used to control the operating parameters for the treatment pulses. In particular, Wham et al teach that it is known to consider tissue desiccation and water content of tissue when considering test pulse results in order to determine the treatment parameters for subsequent treatment pulses. See, for example, paragraph [0024]. The examiner maintains that one of ordinary skill in the art considering the desiccation rate would inherently, or at least obviously, determine whether a tissue had higher or lower water content and the inherent effect on tissue characteristics that would stem from such a water level. Regarding claims 9 and 14, Wham et al also disclose controlling treatment pulses based on impedance measurements and monitors for both increasing and decreasing impedance profiles as a consideration in deriving the parameters for the treatment pulses. See, for example, paragraphs [0071-0077].
To have provided the Francischelli et al system with an estimating unit that determines water content, or desiccation rate, based on the test pulse to determine parameters for treatment pulses would have been an obvious consideration for one of ordinary skill in the art at the time of the invention since Wham et al disclose such a consideration in a similar RF system that uses test pulses to determine tissue characteristics and control the output parameters of the treatment pulses.
Double Patenting
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.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,137,965. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘965 anticipate the claims of the instant application. Accordingly, the instant application claims are not patentably distinct from the ‘965 claims. Here, the more specific patent claims encompass the broader instant application claims. Following the rationale in In re Goodman cited in the preceding paragraph, where applicant has once been granted a patent containing a claim for the specific narrow invention, applicant may not obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
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Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,523,863. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘863 anticipate the claims of the instant application. Accordingly, the instant application claims are not patentably distinct from the ‘863 claims. Here, the more specific patent claims encompass the broader instant application claims. Following the rationale in In re Goodman cited in the preceding paragraph, where applicant has once been granted a patent containing a claim for the specific narrow invention, applicant may not obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Mehta (2010/0217253) discloses another system that provides a test signal to determine tissue characteristics prior to treating skin tissue with RF energy. See, for example, paragraph [0186]. Buysse et al (6,398,779) and Neal, II et al (2016/0066977) disclose other RF systems that utilizes test pulses to determine tissue characteristics and to determine initial treatment pulse parameters for treating tissue with RF energy.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL PEFFLEY whose telephone number is (571)272-4770. The examiner can normally be reached Mon-Fri 8 am-5 pm.
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/MICHAEL F PEFFLEY/Primary Examiner, Art Unit 3794
/M.F.P/August 14, 2026
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