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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 12, 15-16, 18, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tullis et al., (US 20070016185; hereinafter Tullis) in view of Cao, (US 20090065565) and Hofmann et al., (US 6216034; hereinafter Hofmann).
Regarding claim 12, Tullis (Figures 1-2, 10-12, and 21A-21B) discloses a safety assembly for performing endodermal radiofrequency treatments, performed by a needle-shaped transducer (118) supplied by a respective control and management unit (22), ([0048], [0075]) and a cannula (28), made of electrically conducting material and partially superficially insulated ([0050], [0054]), designed to accommodate said needle-shaped transducer (118) and configured to be arranged under the skin of a patient ([0008]), comprising a first identification element (320), uniquely associated with said cannula (28), which incorporates a first unique data string ([0141]), said control and management unit (22) comprising a reader (322) for reading at least said first data string of said first identification element (320), said reader (322) being designed to enable the operation of said transducer (118) upon reading a correct first data string ([0141]-[0142]), said identification element (320) being integral with a coupling adapter (46) which comprises a through internal cavity provided with shaped portions whose shape and dimensions are complementary to those that are present on an outer surface of a grip terminal of said transducer (118) and of a handle (44) of said cannula, for respective mechanical locking in a configuration of full mutual interlocking ([0076], [0096]); or a grip portion (46) of said cannula (28), said grip portion (46) comprising a through internal seat which leads to the internal channel of said cannula (28), said internal seat being provided with shaped portions whose shape and dimensions are complementary to those that are present on an outer surface of a grip terminal of said transducer (118) for a mechanical locking of said transducer (118) in a configuration of full interlocking in the cannula (28), ([0076], [0096]).
Tullis fails to disclose said reader being adapted to enable the operation of said transducer upon reading a correct first data string said first data string corresponding to a single-use activation code, which when read by said reader allows to enable the operation of said transducer only upon a first use of said cannula, and preventing any subsequent reuses of said cannula with which said first identification element is associated. However, Cao (Figures 10-11) teaches a method/apparatus for preventing reuse of medical instruments, wherein an RFID reader (52) is adapted to enable the operation of a probe (60) upon reading a correct first data string, said first data string corresponding to a single-use activation code, which when read by said reader (52) allows to enable the operation of said probe (60) only upon a first use of said probe (60), and preventing any subsequent reuses of said probe (60) which said identification element is associated ([0042]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Tullis to include said reader being adapted to enable the operation of said transducer upon reading a correct first data string said first data string corresponding to a single-use activation code, which when read by said reader allows to enable the operation of said transducer only upon a first use of said cannula, and preventing any subsequent reuses of said cannula which said identification element is associated, as taught by Cao, because the modification would prevent the intentional and non-intentional reuse of medical devices (Cao; [0005]).
Tullis/Cao teaches wherein said transducer (118) comprises a first identification element (320), ([0008], [0141], [0153]), but fails to teach wherein said transducer comprises a second identification element which incorporates a second data string, said second identification element comprised in said transducer being chosen from at least a radiofrequency transceiver, a transponder, and an RFID tag, said reader being adapted to enable operation of said transducer upon a reading of correct and corresponding said first and second data strings. However, Hofmann teaches a safety assembly for performing needle radiofrequency treatments, wherein a transducer (312) includes multiple identification elements (type identification element and voltage identification element) incorporating corresponding data strings such that a reader/device is adapted to enable operation of said transducer upon a reading of correct and corresponding said first and second data strings (Col. 7, line 3 - Col. 8, line 25). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Tullis/Cao to include the transducer comprising a second identification element, as taught by Hofmann, because the modification would provide both type identification and voltage identification for the connected transducer (Col. 7, lines 52-58) to ensure the device is configured properly for use. Furthermore, the first identification (Tullis; 320) element taught by Tullis/Cao incorporates a first data string (Tullis; [0141]), said first identification element (320) comprised in said transducer (118) being chosen from at least a radiofrequency transceiver, a transponder, and an RFID tag (Tullis; [0141]), said reader (Tullis; 322) being adapted to enable operation of said transducer (118) upon a reading of a correct and corresponding said first data string (as taught by Cao; [0042]). Therefore, the second identification element would also incorporate a second data string, said second identification element comprised in said transducer being chosen from at least a radiofrequency transceiver, a transponder, and an RFID tag, said reader being adapted to enable operation of said transducer upon a reading of correct and corresponding said first and second data strings.
Regarding claim 15, Tullis (Figures 1-2, 10-12, and 21A-21B) further discloses wherein said cannula (28) and said adapter (46) are coupled and are disposable, for their single use once they have been mutually coupled and associated with the respective transducer (118), ([0051]).
Regarding claim 16, Tullis (Figures 1-2, 10-12, and 21A-21B) further discloses wherein said identification element (320) is chosen between at least a radiofrequency transceiver, a transponder, and an RFID tag ([0141]).
Regarding claim 18, Tullis (Figures 1-2, 10-12, and 21A-21B) further discloses wherein said reader (322) is chosen from a transceiver integrated in a box-like body of the control and management unit, a transceiver apparatus which can be connected to said unit by means of a respective cable, and a wireless transceiver apparatus which can be connected to said unit remotely ([0089], [0141]).
Regarding claim 20, Tullis (Figures 1-2, 10-12, and 21A-21B) discloses a method for the preventive safety checking of components of a safety assembly according to claim 12 associated with a control and management unit (22) designed to perform endodermal radiofrequency treatments ([0048]), the method including the following steps:- selecting a transducer (118) and connecting it to said control and management unit (22), - selecting a cannula (28) designed to accommodate said transducer (118) and to couple the cannula (28) and the transducer (118), and - detecting, by means of a respective reader (322) associated with said control and management unit (22), a first data string which is incorporated in a first identification element (320) associated with said cannula (320) and activating said transducer (118) only following the detection of a first data string that corresponds to predefined parameters for said cannula (28), ([0115]-[0130], [0141]).
Tullis fails to disclose wherein said first data string corresponds to a single-use activation code, which when detected by said reader allows to enable the operation of said transducer only upon a first use of said cannula, and preventing any subsequent reuses of said cannula with which said first identification element is associated. However, Cao (Figures 10-11) teaches a method/apparatus for preventing reuse of medical instruments, wherein an RFID reader (52) is adapted to enable the operation of a probe (60) upon reading a correct first data string, said first data string corresponding to a single-use activation code, which when read by said reader (52) allows to enable the operation of said probe (60) only upon a first use of said probe (60), and preventing any subsequent reuses of said probe (60) which said identification element is associated ([0042]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Tullis to include said first data string corresponding to a single-use activation code, which when detected by said reader allows to enable the operation of said transducer only upon a first use of said cannula, and preventing any subsequent reuses of said cannula which said identification element is associated, as taught by Cao, because the modification would prevent the intentional and non-intentional reuse of medical devices (Cao; [0005]).
Tullis/Cao further teaches wherein said detection step includes detecting, by means of said respective reader (Tullis; 322) associated with said control and management unit (Tullis; 22), the first data string contained within the first identification element (Tullis; RFID 320) associated with said transducer (Tullis; 118), ([0018], [0141], [0153]), but fails to teach detecting, by means of said respective reader, a second data string contained within a second identification element associated with said transducer, the activation of said transducer being dependent upon the detection also of a second data string that corresponds to predefined parameters for said transducer and to the correct pairing of said cannula with said transducer. However, Hofmann teaches a safety assembly method for performing needle radiofrequency treatments, wherein a transducer (312) includes multiple identification elements (type identification element and voltage identification element) incorporating corresponding data strings such that a reader/device is adapted to enable operation of said transducer upon a reading of correct and corresponding said first and second data strings (Col. 7, line 3 - Col. 8, line 25). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Tullis/Cao to include the transducer comprising a second identification element, such that the method includes detecting a second data string contained within a second identification element associated with said transducer, as taught by Hofmann, because the modification would provide both type identification and voltage identification for the connected transducer (Col. 7, lines 52-58) to ensure the device is configured properly for use. Furthermore, Tullis/Cao teaches that the detection step includes detecting, by means of said respective reader (Tullis; 322), the first data string contained within the first identification element (Tullis; 320) associated with said transducer (Tullis; 118), (Tullis; [0008], [0141], [0153]), the activation of said transducer (Tullis; 118) being dependent upon the detection of the first data string that corresponds to predefined parameters for said transducer and to the correct pairing of said cannula with said transducer (as taught by Cao; [0042]). Therefore, the second identification element would also incorporate a second data string, such that the detection step would also include detecting, by means of said respective reader, a second data string contained within a second identification element associated with said transducer, the activation of said transducer being dependent upon the detection also of a second data string that corresponds to predefined parameters for said transducer and to the correct pairing of said cannula with said transducer.
Response to Arguments
Applicant’s arguments filed 05/12/2026, directed to the newly amended limitations of independent claims 12 and 20, have been fully considered and are persuasive. Therefore, the rejection(s) has/have been withdrawn. However, upon further consideration, a new ground(s) of rejection is/are made in view of a newly found prior art reference Hofmann, which teaches a safety assembly system/method for performing needle radiofrequency treatments, wherein a transducer includes multiple identification elements (type identification element and voltage identification element) incorporating corresponding data strings such that a reader/device is adapted to enable operation of said transducer upon a reading of correct and corresponding said first and second data strings. In combination with Tullis/Cao, the modified device/method teaches the invention as recited at least in amended independent claims 12 and 20.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/C.C.P./Examiner, Art Unit 3794
/EUN HWA KIM/Primary Examiner, Art Unit 3794
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