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 .
Response to Amendment
This action is in response to the preliminary amendment filed on 2/5/2024. In the amendment, claims 1-10 have been cancelled and claims 11-20 have been added.
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 11-20 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 11 recites the limitation "said control and management unit" in line 6. There is insufficient antecedent basis for this limitation in the claim.
Claim 11, lines 8-9 recites ‘a sonotrode rigidly coupled to said rigid hollow stem’. This limitation is deemed indefinite because it is unclear whether applicant intends to recite the rigid hollow stem as part of the claimed invention as the preamble recites the rigid hollow stem in an intended use type recitation. The preamble recites ‘a distal opening for a connection of a substantially rigid hollow stem’, instead of a positive recitation which would resemble ‘a distal opening connected to a substantially rigid hollow stem’. For the purpose of examination, examiner has not considered the ‘rigid hollow stem’ to be a positively recited structure of the claimed invention. See explanation throughout the rejections below.
Claim Rejections - 35 USC § 103
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.
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 11 & 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over Desinger (US Pub. No. 2002/0007200 A1) in view of Houser et al. (US Pub. No. 2012/0116391 A1).
Regarding claim 11, Desinger discloses a multifunctional handpiece 14 (Fig. 1) of the type comprising a main box body 14 (Fig. 1) provided with a proximal opening (paragraph [0022]) for an entry of a power supply and control cable (NOTE: ‘power supply’ and ‘control cable’ are not positively recited by this phrasing since it is recited that the opening is ‘for an entry of’ said elements, which is an intended use/configured to type phrasing, not a positive recitation of these elements), with an optional control assembly (NOTE: the use of the term ‘optional’ makes the ‘control assembly’ an element of the claim that is not required to be in the prior art for anticipatory purposes), and with a distal opening 10 (Fig. 1) for a connection of a substantially rigid hollow stem (EXAMINER NOTE: the ‘substantially rigid hollow stem’ is NOT positively recited as part of the claimed invention by the phrasing ‘for a connection of’, rather, the claim is reciting that the handpiece has a distal opening that is intended and configured to be used to connect a hollow stem; for this reason, the ‘substantially rigid hollow stem’ is not required by the prior art), and further comprising: at least one ultrasound transducer 6 (Fig. 1) connected to a sonotrode 2 (Fig. 1) rigidly coupled to said rigid hollow stem (see 35 USC 112, 2nd section above regarding the ‘rigid hollow stem’), and wherein said rigid hollow stem is at least partially made of electrically conducting material and comprises, on a proximal part of an external surface thereof, a cladding made of an electrically insulating material, and accommodates within an internal cavity thereof said cable , a distal portion of said rigid hollow stem, without external cladding, being configured for a transfer of radiofrequency energy to tissues of a patient against which it is juxtaposed, said radiofrequency energy being adjusted by said external control and management unit (the preceding italicized language is describing specifications of the ‘rigid hollow stem’ which is not being considered to be positively recited as part of the claimed invention based upon the wording of the preamble - see 35 USC 112, 2nd paragraph section above for further explanation; because of this, the preceding italicized limitations are not required by the prior art).
Desinger fails to further disclose wherein said ultrasound transducer being controlled by an external control and management unit, at least one temperature sensor, arranged inside said box body, controlled by said control and management unit and comprising a cable made of electrically conducting material.
However, Houser et al. teach an ultrasonic surgical instrument having a handpiece that houses an ultrasound transducer 180 (Fig. 2) being controlled by an external control and management unit 1000 (Fig. 2; at least paragraph [0038]), and at least one temperature sensor 190 (Fig. 2; paragraph [0034]) arranged in said box body (Fig. 2), controlled by the external control and management unit 1000 and comprising a cable made of electrically conducting material (wire shown in Fig. 2 that electrically connects the sensor to the control unit 1000 for transmitting data thereto - this is considered to be a cable that is electrically conducive), in order to monitor the status of the transducer temperature during use to deactivate the transducer if a certain predetermined temperature is reached to avoid overheating of the instrument (paragraph [0038]).
It would have been beneficial and obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the temperature sensor and control/management unit suggested and taught by Houser et al. in the ultrasonic surgical instrument disclosed by Desinger for the purpose of monitoring the internal components (i.e. the transducer) to avoid overheating of the system during its use to avoid damage to the internal components and/or overheating of the end effector.
Regarding claim 16, the limitation ‘wherein said rigid hollow stem is made of a material chosen from surgical steel, titanium, metallic alloys, and composite materials’ is drawn to the ‘rigid hollow stem’ which is not being considered as a positively recited element in the claims (see rejection of claim 11 and 35 USC 112, 2nd paragraph section above).
Regarding claim 17, the limitation ‘wherein said cladding is constituted by a sheath made of polymeric material with high electrical resistivity with dimensions adapted to cover all of the external surface of said stem except for said distal portion of said rigid hollow stem’ is drawn to the ‘rigid hollow stem’ which is not being considered as a positively recited element in the claims (see rejection of claim 11 and 35 USC 112, 2nd paragraph section above).
Regarding claim 18, the limitation ‘wherein said distal portion without cladding has an axial length, with respect to a longitudinal axis of said rigid hollow stem, comprised between 1 mm and 100 mm’ is drawn to the ‘rigid hollow stem’ which is not being considered as a positively recited element in the claims (see rejection of claim 11 and 35 USC 112, 2nd paragraph section above).
Regarding claim 19, Desinger in view of Houser et al. disclose the multifunctional handpiece according to claim 11 (see rejection above) and Houser et al. teaches the external module which accommodates said external control and management unit 1000. Desinger further discloses at least one electromagnetic generator of a type chosen from monopolar and bipolar (monopolar - paragraph [0008]), but fails to disclose wherein the generator is a radiofrequency generator. However, Houser et al. teach their ultrasonic surgical instrument to use a monopolar radiofrequency generator to produce the frequencies (paragraph [0082]). Since both generators are monopolar and produce frequencies to be delivered to an ultrasound transducer, it is considered that Desinger’s electromagnetic generator could be swapped for a radiofrequency generator without affecting the performance or intended use/function of the system.
Claims 12 & 13 are rejected under 35 U.S.C. 103 as being unpatentable over Desinger (US Pub. No. 2002/0007200 A1) in view of Houser et al. (US Pub. No. 2012/0116391 A1) further in view of Babaev (US Pub. No. 2011/0125174 A1).
Regarding claims 12 & 13, Desinger in view of Houser et al. fail to explicitly disclose wherein said ultrasound transducer is configured to generate vibrations with a frequency comprised between 16 kHz and 500 MHz and to transfer said vibrations to said sonotrode [claim 12]; and wherein said sonotrode is configured to transmit vibrations with a frequency comprised between 16 kHz and 500 MHz to said stem [claim 13]. Desinger only discloses that the transducer/sonotrode perform at high frequency voltage without further limiting of the voltage value. However, Babaev teaches an ultrasonic surgical cutting instrument wherein the cutting frequency includes any frequency within the ultrasound spectrum, such as, but not limited to, between approximately 15kHz and approximately 3 mHz (paragraph [0047]). It is considered that in view of the teachings of Babaev’s ultrasonic cutting frequencies that one of ordinary skill in the art before the effective filing date of the claimed invention would have recognized the claimed range as falling within the ultrasound spectrum and would include a high frequency limit of the ultrasound spectrum (i.e. the claimed 500MHz) as Desinger indicates its device is intended to perform within high frequencies of the ultrasound spectrum.
Allowable Subject Matter
It is noted that claims 14, 15, & 20 do not have a prior art rejection. However, these claims have been rejected under 35 USC 112, 2nd paragraph. The prior art fails to further disclose, teach, or suggest wherein said ultrasound transducer and said sonotrode comprise a respective longitudinal channel for a passage of said cable [claim 14]; wherein said sonotrode comprises a threaded terminal for a coupling of a proximal end of said rigid hollow stem, provided with a thread which is complementary to a thread of said threaded terminal [claim 15]; and wherein said external module, by means of said external control and management unit, is configured to deliver an electric current for a power supply of said rigid hollow stem which is adapted to determine a heating of the tissues of the patient that are in contact with said distal portion of said rigid hollow stem to a temperature comprised between 38oC and 95oC, said electric current for the power supply of a thermocouple having a frequency comprised between 100 kHz and one GHz [claim 20].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHLEY LAUREN FISHBACK whose telephone number is (571)270-7899. The examiner can normally be reached M-F 7:30a-3:30p.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at (571) 272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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ASHLEY LAUREN FISHBACK
Primary Examiner
Art Unit 3771
/ASHLEY L FISHBACK/Primary Examiner, Art Unit 3771 April 30, 2026
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