DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/27/2025 has been entered.
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 Objections
Claim 12 objected to because of the following informalities:
“first data string said first data string” in line 14 should be written “first data string, said first data string”
“said cannula which” in line 16 should be written “said cannula with which”
Appropriate correction is required.
Claim 20 objected to because of the following informalities:
“said cannula which” in line 15 should be written “said cannula with which”
Appropriate correction is required.
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.
Claim(s) 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tullis et al., (US 20070016185; hereinafter Tullis).
Regarding claim 19, Tullis (Figures 1-2, 10-12, and 21A-21B) discloses a coupling adapter (46) comprised in an electromedical devices for executing endodermal radiofrequency treatments, said electromedical device comprising a needle-shaped transducer (118), said needle-shaped transducer (118) comprising a grip terminal (proximal end terminal); a respective control and management unit (22) that supplies said needle-shaped transducer (118), ([0048], [0075]); a cannula (28), made of an electrically conducting material and partially superficially insulated ([0050], [0054]), designed for the accommodation of said needle-shaped transducer (118) and configured to be arranged under the skin of a patient ([0008]), said cannula (28) comprising a handle (44); a through internal cavity (57) of said coupling adapter (46) which is provided with shaped portions whose shape and dimensions are complementary to those that are present on an outer surface of said grip terminal (proximal end terminal) of said transducer (118) and of said handle (44) of said cannula (28) for respective locking in a configuration for full mutual interlocking between said grip terminal (proximal end terminal) of said transducer (118) and said coupling adapter (46) and said handle (44) of said cannula, with said coupling adapter (46) being arranged between said grip terminal and said handle (44), ([0054], [0076], [0096]), said coupling adapter (46) comprising an identification element (320) which incorporates a unique data string, said control and management unit (22) comprising a reader (322) of at least said data string of said identification element (320), said reader (322) being designed to enable the operation of said transducer (118) upon a correct data string ([0141]-[0142]).
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, 15-18, and 20-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tullis in view of Cao, (US 20090065565).
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 an 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 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 which said 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]).
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 17, Tullis (Figures 1-2, 10-12, and 21A-21B) further discloses wherein said transducer (supply electrode 118) comprises said identification element (RFID) which incorporates a second data string, said identification element (RFID) comprised in said transducer being chosen from at least a radiofrequency transceiver, a transponder, and an RFID tag, said reader (322) being designed to enable operation of said transducer (118) upon a reading of correct and corresponding first and second data strings ([0018], [0141], [0153]).
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 an 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 which said 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]).
Regarding claim 21, Tullis (Figures 1-2, 10-12, and 21A-21B) further discloses wherein said detection step includes detecting a second data string contained within an identification element (RFID) associated with said transducer (118), the activation of said transducer (118) being dependent upon the detection also of a second data string that corresponds to predefined parameters for said transducer (118) and to the correct pairing of said cannula (28) with said transducer ([0018], [0141], [0153]).
Response to Arguments
Applicant's arguments filed 05/27/2025 have been fully considered.
Applicant’s arguments, with regard 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 made in view of newly found prior art reference Cao, which teaches a method/apparatus for preventing the reuse of medical instruments. In combination with Tullis, the modified device/method teaches the invention as claimed at least in amended independent claims 12 and 20.
In response to Applicant’s argument that the Tullis reference fails to disclose the newly amended limitations of claim 19, Examiner respectfully disagrees. Tullis (Figures 1-2, 10-12, and 21A-21B) discloses that the full mutual interlocking is between said grip terminal (proximal end terminal) of said transducer (118) and said coupling adapter (46) and said handle (44) of said cannula, with said coupling adapter (46) being arranged between said grip terminal and said handle (44), ([0054], [0076], [0096]). Therefore, Examiner maintains that the Tullis reference discloses the invention as claimed at least in amended independent claim 19.
Conclusion
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/C.C.P./Examiner, Art Unit 3794
/EUN HWA KIM/Primary Examiner, Art Unit 3794