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 . 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
The listing of references in the PCT international search report is not considered to be an information disclosure statement (IDS) complying with 37 CFR 1.98. 37 CFR 1.98(a)(2) requires a legible copy of: (1) each foreign patent; (2) each publication or that portion which caused it to be listed; (3) for each cited pending U.S. application, the application specification including claims, and any drawing of the application, or that portion of the application which caused it to be listed including any claims directed to that portion, unless the cited pending U.S. application is stored in the Image File Wrapper (IFW) system; and (4) all other information, or that portion which caused it to be listed. In addition, each IDS must include a list of all patents, publications, applications, or other information submitted for consideration by the Office (see 37 CFR 1.98(a)(1) and (b)), and MPEP § 609.04(a), subsection I. states, “the list ... must be submitted on a separate paper.” Therefore, the references cited in the international search report have not been considered. Applicant is advised that the date of submission of any item of information in the international search report will be the date of submission of the IDS for purposes of determining compliance with the requirements for the IDS with 37 CFR 1.97, including all timing statement requirements of 37 CFR 1.97(e). See MPEP § 609.05(a).
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 701, 801 and 802 (fig. 9). Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 23 and 25 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.
Regarding claims 23, the claim recites a step and does not include any structure at all, not even a functional limitation (e.g. the generator is configured to output a type of signal) such that it is not clear what structural limitation is being recited by the claims.
Regarding claim 25, the term “close proximity” is a relative term which renders the claim indefinite. The term “close proximity” 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. It is not clear how close the nebulously defined “first area” must be to at least one energy delivery element to qualify as being in “close proximity.”
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 22 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 22 merely recites that there are areas in which the RF/PEF energy is delivered, without qualifying the areas at all, which is an inherent attribute of the system of claim 21 such that claim 22 does not further limit the structure recited by claim 21. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 –
(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.
Claims 21, 22, 24, 26, 27 and 40 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nanda (US 2014/0277219).
Regarding claims 21, 22, 24, 26, 27 and 40, Nanda discloses a system and method for treating hypodermal tissue (i.e. subcutaneous tissue, [0049]) including at least two generators for generating at least radiofrequency (RF) and pulsed electric fields (PEF) for electroporation ([0072], see also [0064] regarding simultaneous use of various energies). The system further includes an applicator (e.g. 400, fig. 4) with a plurality of energy delivery elements ([0096]) coupled to the generators for delivering RF and/or PEF to tissue (fig. 1) in a monopolar or bipolar manner ([0062]-[0063], [0076]). The system also includes a controller for controlling operation of the system, including the applied energies ([0078], [0083]). It is noted “single application” is extremely broad and is understood to at least include a single procedure (note “plan,” singular, in [0083] indicating that the “one or more power supplies” are operated during a single procedure). The RF energy used for ablation is “configured to” heat (RF is operational to cause resistive heating) tissue (including “skin tissue”) and the PEF energy is “configured to” cause electroporation (see also [0057]). For the RF/PEF energy to be used to treat tissue, they must be applied to areas of tissue which can be considered the first and second areas. Since the areas between the electrodes which are used to apply RF/PEF overlap (e.g. 302a-b in fig. 3A, 410a-b in fig. 4, etc.), the areas of tissue treated by RF/PEF also overlap.
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 25, 32-35, 37 and 39 are rejected under 35 U.S.C. 103 as being unpatentable over Nanda.
Regarding claim 25, Nanda does not specifically disclose the relative sizes of the RF area and the PEF area. However, it is commonly known in the art that RF/PEF energy parameters influence the size of ablation (see Conclusion for examples). Further, there are exactly three options when considering the relative size of the RF/PEF areas: RF larger than PEF, PEF larger than RF and RF equal size with PEF. It has been held that choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success, is an obvious modification (MPEP 2141(III)). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to allow the generators of Nanda to produce any/all of the three possible relative sizes of RF/PEF ablation zones, including PEF larger than RF, that would produce the predictable result of allowing a user to treat tissue in a desired manner.
Regarding claims 32-35, Nanda also discloses a wide range of PEF parameters including 1 millisecond to 10 seconds ([0076]), such that the system is “configured to” deliver the pulses with a duration of every value in that range. Further, the very use of “pulses” ([0076]) requires there to be at least two pulses which are provided in a manner that can be considered “continuous” (i.e. any at least two pulses can be considered continuous pulses). This is a generous interpretation of the term “continuous” in this context because that term can also mean there are no pulses (see e.g. [0055]). Nanda further discloses the duration of a pulse train can include microseconds to milliseconds “or more” depending on various factors ([0124]-[0125]). Nanda does not specifically disclose the exact pulse train duration, number of trains, number of pulses in a train or the exact pulse width. However, Nanda further teaches that the specific pulse parameters are dependent on the goals of the procedure, and that various values can be set by a user, thus establishing that a person of ordinary skill in the art would be able to choose appropriate values ([0055], [0057], [0062], [0065], [0073], [0075], [0078], etc.). Thus as shown by Nanda, the parameters necessary to produce electroporation with PEFs are very well understood and there is no evidence that the claimed ranges produce an unexpected result (within the meaning of MPEP 716.02(a)). Therefore, before the application was filed it would have been obvious to one of ordinary skill in the art to modify Nanda to use any commonly known number of pulses, number of pulse trains, train duration (i.e. the number of pulses, pulse widths and pulse delay), and pulse duration, including in the ranges taught by Nanda, that would produce the predictable result of causing electroporation of tissue using PEFs.
Regarding claims 37 and 39, Nanda does not disclose 4-200 energy delivery elements. However, Nanda does broadly teach that a plurality of energy delivery elements may be included ([0076]), where a mere duplication of parts has been held to be an obvious modification (MPEP 2144.04(VI)(B)). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to modify Nanda to have any commonly known number of energy delivery elements, including at least 4, that would produce the predictable result of allowing a user to treat tissue in a desired manner. Nanda further discloses the electrodes are configured to not penetrate the skin tissue (fig. 4, fig. 5).
Claims 23 and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Nanda in view of Boll (US 2018/0000533).
Regarding claims 23 and 40, Nanda does not specifically disclose the exact temperature the RF generator is capable of producing at the electrodes under some hypothetical conditions. However, ablation temperatures in the ranges of 43-120°C are common in the art. Boll discloses another system for treating hypodermal tissue ([0003]) and teaches that RF energy may be applied to produce temperatures in the range of 42-47°C ([0079]). Therefore, before the application was filed, it would have been obvious to modify the system of Nanda to include an RF generator capable of generating temperatures above 43°C such as taught by Boll to produce the predictable result of allowing a user to treat hypodermal tissue in a desired manner. It is noted that while Nanda alone is understood to disclose the steps of the claim 40 as discussed above with respect to claim 21, within the breadth of the claim language, claim 40 is rejected again here in view of Boll because the specific temperature ranges disclosed by Boll will also result in destruction of cells and non-cellular tissue (note the explicit discussion of collagen in [0016], [0079] and [0111]), in addition to the destruction caused by electroporation disclosed by Nanda. The areas being undefined in the claim therefore include all possible areas.
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Nanda in view of Forsyth (US 2020/0129230).
Regarding claim 28, the system of Nanda does not specifically disclose the generators can produce monophasic and biphasic PEF signals. However, these are commonly known in the art such as taught by Forsyth ([0074]). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to modify the system of Nanda to produce any commonly known type of PEF signal, including monophasic and biphasic signals as taught by Forsyth, that would produce the predictable result of allowing a user to treat tissue in a desired manner.
Claims 29-31 are rejected under 35 U.S.C. 103 as being unpatentable over Nanda in view of Athos (US 2018/0243558).
Regarding claims 29-31, Nanda does not disclose the specific circuitry used to generate PEFs because such circuitry is commonly known in the art. Athos, for example, discloses a PEF system and teaches that a number of voltage multipliers (510, 520, 530, fig. 5) each comprising switches (516, 526, 536) and a capacitor (515, 525, 535) can be charged in parallel ([0099], fig. 6A) and discharged in series ([0102], fig. 6B) to produces pulses having desired characteristics ([0071]). The switches can be any of several commonly known types including semiconductor switches ([0086]). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to modify the system of Nanda to use any commonly known circuitry for generating PEFs, including the circuitry disclosed by Athos, that would produce the predictable result of allowing a user to apply PEFs to tissue in a desired manner.
Claims 36 is rejected under 35 U.S.C. 103 as being unpatentable over Nanda in view of D’Agostino (US 2021/0113265)
Regarding claim 36, Nanda does not disclose the specific pulse energy. However, as established, operation PEF parameters are well within the level of ordinary skill in the art. D’Agostino discloses another PEF system and teaches a range of 0.04 J/cm2 to 27 J/cm2 can be used ([0350]). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to modify the system of Nanda to use any commonly known pulse energy, including 0.01-2.7 J/mm2 (after conversion) as taught by D-Agostino, that would produce the predictable result of treating tissue in a desired manner.
Claims 38 is rejected under 35 U.S.C. 103 as being unpatentable over Nanda in view of Deem (US 2004/0060989).
Regarding claim 38, Nanda discloses the use of needles (fig. 6), but does not disclose the needles are adjustable within a certain range. However, making elements adjustable is an obvious modification (MPEP 2144.04(V)(D)) and treating subcutaneous tissue at a depth of 0.2-15 mm is common in the art such as taught by Deem ([0116]). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to further modify the system of Nanda to use extendable needles, and to have that extension be within the range of 0.2-15 mm as taught by Deem, that would produce the predictable result of allowing a user to treat tissue at that depth.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Regarding the general teaching that the level of ordinary skill in the art includes the relationship between ablation size and RF energy parameters, see paragraph [0031] of US 2019/0274755 to Smith. Regarding the general teaching that the level of ordinary skill in the art includes the relationship between ablation size and PEF energy parameters, see paragraph [0139] of US 2013/0184702 to Neal. Regarding a PEF system that teaches a wide range of pulse parameters including energy values, see table 1 of US 2021/0177503 to Altmann. Regarding another PEF system which uses capacitors and switches to form voltage multipliers which are controlled to generate the pulses, see discussion associated with figure 13B of US 2020/0289185 to Forsyth. Regarding the general teaching that using at least one generator can be used to output RF and electroporation energy, sequentially or simultaneously, thus establishing the level of ordinary skill in the art is high and includes the circuitry necessary to produce these kinds of systems, see paragraph [0096] of US 2017/0189096 to Danziger. Regarding another skin treatment device which explicitly uses RF and electroporation energy, see paragraph [0112] of US 2021/0022797 to Wainberg.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL WAYNE FOWLER whose telephone number is (571)270-3201. The examiner can normally be reached Monday-Friday (9-5).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph Stoklosa can be reached at 571-272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANIEL W FOWLER/Primary Examiner, Art Unit 3794
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