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 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.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed applications, Application Nos. 15/721,979 and 18/059,443, fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Specifically, the prior applications fail to provide adequate support for the “reducing skin surface temperature” steps and “cooling element” of claims 1-10.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “moving mechanism to move” and “moving mechanism configured to move” in claims 1-10.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
Claim 3 is objected to because of the following informalities: “applied to sequentially to-- should be amended to --applied sequentially to--. 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 1-8 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 1 recites the limitation "the skin surface" in line 9. There is insufficient antecedent basis for this limitation in the claim.
Claims 2-8 are rejected by virtue of their dependency upon an indefinite base claim.
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 1-9 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Kreindel (US 2019/0099599) in view of Weber et al. (US 2008/0287943).
Regarding claim 1, Kreindel teaches a method for tissue fractional coagulation comprising: applying a tip of a radio-frequency (RF) device to a treated tissue (see [0034]), wherein a distal end of said RF device is in contact with a surface of the treated tissue (see [0034]), said RF device comprising a plurality of needles having electrically conductive tips (see tips of electrically conductive needles 22, Figs. 4-5); deploying said plurality of needles into the treated tissue (see [0034]), wherein a moving mechanism moves said plurality of needles so that the tip of each of said needles protrudes distally through spaces in the distal end of the RF device into the treated tissue at least to one depth (see motor 41 and actuator 42 that move the tips such that they protrude distally through spaces in the return electrode 44 and into tissue at a depth, [0034], Fig. 2 and 5); applying a radiofrequency (RF) voltage between said electrically conductive tips, which are at said one depth (see [0037]), and a return electrode applied to the skin surface (see return electrode 24 applied to skin, [0034]); retracting said needles out of the treated tissue after RF energy is applied at the at least one depth (see rotation of the motor in an opposite direction to retract the needles out of the tissue after RF energy is applied, [0037]). However, Kreindel fails to disclose reducing skin surface temperature using a pre-cooled surface of the device which is in contact with the treated tissue.
Weber teaches a device for skin tissue treatment (see Figs. 1-2 and 10) wherein the device comprises electrodes of a treatment tip configured to apply an RF treatment voltage (see electrodes 12 of the treatment tip 10, Figs. 1-2 and 10). Weber further teaches reducing skin surface temperature using the pre-cooled electrode surfaces in contact with the tissue and that cooling can be adjusted by providing a pre-treatment cooling period, a concurrent-treatment cooling period, and a post-treatment cooling period (see [0033] and [0035]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of using a treatment tip as disclosed by Kreindel to further include reducing skin surface temperature using a pre-cooled surface of the device which is in contact with the treated tissue in light of Weber, the motivation being to provide the additional advantage of more precise control of the depth and extent of tissue damage applied by the device (see Weber [0033]).
Regarding claim 2, Kreindel in view of Weber further teaches wherein said return electrode surrounds each needle (as shown in Kreindel: Figs. 2 and 4) and is cooled (as a result of the above combination, the electrodes in contact with the tissue would be cooled to better control treatment depth and extent).
Regarding claim 3, Kreindel further discloses wherein RF energy is applied sequentially to the plurality of needles (see [0016]).
Regarding claim 4, Kreindel in view of Weber further teaches wherein the treated tissue is pre-cooled prior to applying the RF voltage (see Weber: [0035]).
Regarding claim 5, Kreindel in view of Weber further teaches wherein the skin surface is cooled after applying the RF voltage (see Weber: [0035]).
Regarding claim 6, Kreindel further discloses wherein RF energy is applied at multiple depths (see the application of RF energy that occurs at multiple depths along the longitudinal length of the exposed section of the needles, [0020], [0034]-[0037], Figs. 4-5).
Regarding claims 7 and 8, Kreindel in view of Weber fails to specifically teach wherein the skin surface temperature is cooled below normal skin temperature, or to a range of 0-20 ºC. Weber further teaches depth and extent of tissue damage can be readily controlled by controlling the amount of energy delivered to the tissue 34, and by controlling the amount of cooling delivered to the tissue 34. In one embodiment, a nozzle member 35, which may include multiple individual nozzles, may be used to deliver a spray 37 of a cryogen or coolant toward the electrodes 12 for controlling the temperature of the electrodes 12 and, thereby, the temperature of the patient's tissue 34 (see Weber [0033]) and that cooling can be adjusted by providing a pre-treatment cooling period, a concurrent-treatment cooling period, a post-treatment cooling period, as desired, and also by controlling the temperature of the treatment tip during the cooling to be, for example, either extremely cold, medium cooled, or mildly cooled, as desired. The treatment depth may also be contingent upon other variables, such as the specific type of tissue 34 involved in the treatment (see Weber [0035]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have cooled below normal skin temperature, or to a range of 0-20 ºC in order to adequately control treatment depth and extent dependent upon the specific type of tissue being treated in light of Weber, and further 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 involves only routine skill in the art. In re Aller, 105 USPQ 233. See MPEP 2144.05.
Regarding claim 9, Kreindel discloses a device for tissue fractional coagulation (see Figs. 1-5) comprising: a plurality of conductive elements (see electrically conductive needles 22, Figs. 4-5); a return electrode (see return electrode 24, [0034]), wherein each of said plurality of conductive elements is surrounded by said return electrode (as shown in Figs. 2 and 4-5, see [0032]) and a total area of said return electrode is larger than a total area of said plurality of conductive elements (see [0019], [0036], and [0040]); and a moving mechanism configured to move said plurality of conductive elements relative to said return electrode (see motor 41 and actuator 42 that move the tips such that they protrude distally through spaces in the return electrode 44 and into tissue at a depth, [0034], Fig. 2 and 5), and wherein in an inactive mode of the device, said plurality of conductive elements do not protrude distally beyond said return electrode (see [0033]), and in an active mode of the device, tips of said plurality of conductive elements protrude distally from a distal face of a housing, said distal face being a skin-contact surface for contacting skin that lies over a tissue (see tips protruding distally from the distal face of the housing, [0034]-[0035]), and wherein said return electrode is located at least partially on said skin-contact surface and is located proximal to said tips (see return electrode 24 located on the distal skin contact surface and proximal to the tips of electrode 22, Fig. 4); and wherein said plurality of conductive elements is operatively coupled to a RF generator (see operative coupling to cable 14 through which the RF energy passes to the conductive element, [0031], see also claim 7); wherein said RF generator has an operating mode in which RF energy is applied between conductive elements and said return electrode to create an approximately equal thermal effect around each of said conductive elements (see [0040]). However, Kreindel fails to further disclose wherein a cooling element is thermally connected to said skin-contact surface and to said return electrode.
Weber teaches a device for skin tissue treatment (see Figs. 1-2 and 10) wherein the device comprises electrodes of a treatment tip configured to apply an RF treatment voltage (see electrodes 12 of the treatment tip 10, Figs. 1-2 and 10). Weber further teaches reducing skin surface temperature using the pre-cooled electrode surfaces in contact with the tissue and that cooling can be adjusted by providing a pre-treatment cooling period, a concurrent-treatment cooling period, and a post-treatment cooling period (see [0033] and [0035]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the skin-contact surface and return electrode as disclosed by Kreindel to further include a cooling element that is thermally connected to said skin-contact surface and to said return electrode in light of Weber, the motivation being to provide the additional advantage of more precise control of the depth and extent of tissue damage applied by the device (see Weber [0033]).
Regarding claim 10, wherein said plurality of conductive elements are partially coated with an electrically insulating material (see [0020]).
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 1-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 5, 8-9 and 13-14 of copending Application No. 18/059,443 in view of Weber et al. (US 2008/0287943). Claims 1-2, 5, 8-9 and 13-14 of copending Application No. 18/059,443 generally anticipate claims 1-10 of the instant application with exception to reducing skin surface temperature using a pre-cooled surface of the device which is in contact with the treated tissue (and the additional cooling steps of claims 2, 4-5, and 7-8) as well as wherein a cooling element is thermally connected to said skin-contact surface and to said return electrode. However, these additional limitations are rendered obvious in view of Weber under the same obviousness rationale as that set forth in claims 1, 2, 4-5, 7-8 and 9 above.
This is a provisional nonstatutory double patenting rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN W COLLINS whose telephone number is (408)918-7607. The examiner can normally be reached on M-F 9:00 AM-5:00 PM ET.
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, Joanne Rodden can be reached on 303-297-4276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SEAN W COLLINS/Primary Examiner, Art Unit 3794