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
In light of Applicant’s amendment, claim(s) 1 and 21 is/are amended. Claim 8-9 were previously canceled. Claims 1-7 and 21 are pending examination.
Response to Arguments
Applicant’s arguments, filed 10/9/2025, with respect to the rejection(s) of claim(s) 1 and 21 under U.S.C. 103 have been fully considered and are persuasive. Regarding claim 1, the amended limitation requiring “a plurality of respective piezoelectric crystals in the handpiece with a plurality of respective electrical signals, each respective piezoelectric crystal having a different respective frequency” overcomes the previous rejection as written. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Lo in view of Boukhny, Brennan and Frankhouser
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 1-7 and 21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 and 21 were amended to include the limitation “each respective piezoelectric crystal having a different respective frequency”, however, there is no support in the present disclosure for the limitation. The closest mention is the disclosure of the original claim language “A method includes vibrating a needle (16) of a phacoemulsification handpiece (12) by driving one or more piezoelectric crystals (22) in the handpiece with one or more electrical signals having different respective frequencies using one or more respective drive modules”. Based on this, there isn’t any indication that each crystal needs a different respective frequency, just that the signals can have one or more different respective frequencies. Thus, the limitation is seen as new matter. Claims 2-7 are rejected due to their dependence on claim 1.
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) 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over Lo et al. (US 4954960 A) (previously of record) in view of Boukhny et al. (US 20060041220 A1), Brennan et al. (US 20150148615 A1) (previously of record) and Frankhouser et al. (US 20120209303 A1) (previously of record).
Regarding claim 1, Lo discloses a method, comprising:
vibrating a probe (22) of a phacoemulsification handpiece by driving one or more piezoelectric crystals (28, 30) in the handpiece with one or more electrical signal (electrical driving signals) each having a different respective frequency (Col 2, lines 56-60; Col 9, lines 9-10, 25-35);
inserting the probe into an eye of a patient (the probe encounters liquids in the eye, thus had to have been inserted into the eye of the patient) (Col 7, lines 11-15);
tuning the respective frequencies of the one or more electrical signal to respective one target frequency (mechanical resonant frequency) (Col 6, lines 62-65), measuring electrical impedance (load impedance) (Col 2, lines 56-60; Col 12, line 46-51); and
in response to at least one of the measured electrical impedances undergoing a change exceeding a preset impedance change (when phase angle is not 0) (Col 3, lines 66- Col 4, line 4; Col 4, lines 21-28, 42-53; Col 14, lines 11-31) providing a visual indication (display data) that material in the eye surrounding the probe has changed (Col 5, lines 54-57; Col 7, line 40-46; Col 9, lines 43-46; Col 14, lines 38-39).
Lo fails to explicitly disclose a plurality of respective piezoelectric crystals in the handpiece with a plurality of respective electrical signals, each respective piezoelectric crystal having a different respective frequency; vibrating a needle of a phacoemulsification handpiece, inserting the needle into an eye of a patient and providing an audio or visual indication that material in the eye surrounding the needle has changed.
However, Boukhny is directed to a phacoemulsification device and teaches a plurality of respective piezoelectric crystals (14) in the handpiece with a plurality of respective electrical signals (longitudinal signal and torsional signal), each respective piezoelectric crystal having a different respective frequency (Paragraph 0019; 0024).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Lo such that a plurality of respective piezoelectric crystals in the handpiece with a plurality of respective electrical signals, each respective piezoelectric crystal having a different respective frequency, as taught by Boukhny, as both references and the claimed invention are directed to phacoemulsification devices. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lo with the teachings of Boukhny by incorporating a plurality of respective piezoelectric crystals in the handpiece with a plurality of respective electrical signals, each respective piezoelectric crystal having a different respective frequency in order to achieve both torsional motion and longitudinal motion (Paragraph 0010).
However, Brennan et al is directed to a phacoemulsification system and method and teaches a probe comprises a needle (Paragraph 0070).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Lo such that the probe includes a needle, as taught by Brennan, which would then teach vibrating a needle of a phacoemulsification handpiece, inserting the needle into an eye of a patient and providing an indication that material in the eye surrounding the needle has changed as both references and the claimed invention are directed to phacoemulsification. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lo with the teachings of Brennan by incorporating a probe with a needle in order to penetrate the eye during surgery.
Further, Frankhouser is directed to a surgical system and teaches updating a user display including audible or visual feedback in response to changes in electromechanical properties such as force, impedance magnitude, and phase angle (Paragraph 0206). When modified with Lo, the combination would result in providing an audio or visual indication that material in the eye surrounding the needle has changed, as a change in phase angle indicates a change in the material of the eye.
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Lo as modified by Boukhny and Brennan by providing an audio or visual indication that material in the eye surrounding the needle has changed, as taught by Frankhouser, as both references and the claimed invention are directed to surgical systems. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lo as modified by Boukhny and Brennan with the teachings of Frankhouser by incorporating providing an audio or visual indication that material in the eye surrounding the needle has changed in order to alert the user of operating conditions, such as the tissue/fluids surrounding the needle (Paragraph 0206).
Regarding claim 3, Lo as modified by Brennan further teaches wherein the step of tuning the one or more frequencies comprises setting the one or more target frequencies to be respective one or more resonance frequencies of the one or more piezoelectric crystals as measured by the drive modules (the resonance frequencies of piezoelectric crystals comprise the resonance frequency of the probe as whole) (Col 3, line 48-51; Col 5, lines 21-35).
Regarding claim 4, Lo as modified by Brennan further teaches wherein the step of tuning the frequencies comprises setting the one or more target frequencies to be respective one or more resonance frequencies of the one or more piezoelectric crystals, so as to differentiate between the needle engaging with the lens, and the needle disengaging from a lens of the eye (change in current happens depending on when the needle engages with the lens, as that affects the impedance and phase angle) (Col 7, lines 11-24).
Regarding claim 5, Lo as modified by Brennan further teaches wherein the change in the electrical impedance is in response to the needle engaging with a lens of the eye (Col 7, lines 11-24).
Regarding claim 6, Lo as modified by Brennan further teaches in response to the change in the respective electrical impedance exceeding the preset impedance change (Col 14, lines 11-31), adjusting the respective frequency of the one or more electrical signals to comprise an electrical resonant frequency thereof (changing drive frequency to a frequency where the phase angle is 0, electrical resonant frequency happens when phase angle is 0, thus the frequency comprises an electrical resonant frequency) (Col 7, lines 11-24; Col 7, line 40-46; Col 29, lines 1-13).
Regarding claim 7, Lo as modified by Brennan further teaches wherein tuning the one or more frequencies of the one or more electrical signals to respective one or more target frequencies comprises adjusting one or more of the frequencies off-resonance (tuning away from the original optimal resonance until finding a new optimal resonance) (Col 6, line 36-61), in order to have an inverse change in an electrical impedance magnitude with a decreased versus an increased mechanical load on the needle (such an inverse relationship is known as a result of changing resonance) (Col 7, lines 11-20; Col 26, line 32-37).
Claim(s) 2 is rejected under 35 U.S.C. 103 as being unpatentable over Lo in view of Boukhny, Brennan and Frankhouser, as applied to claim 1 above, and further in view of Houser et al. (US 20190201037 A1).
Regarding claim 2, Lo as modified by Brennan and Frankhouser discloses the method according to claim 1 but fails to explicitly disclose the method further comprising, in response to at least one of the respective electrical impedances undergoing a change, changing a vibration power level to change a level of vibration of the needle.
However, Houser is directed to an ultrasonic surgical instrument and teaches changing a vibration power level to change a level of vibration of an ultrasonic transducer to control an ultrasonic blade (i.e., needle) in response to measured resonant frequencies (Paragraph 0541; 0635-636). Since Lo uses resonant frequencies to coordinate with changing electrical impedances, the combination would result in in response to at least one of the respective electrical impedances undergoing a change, changing a vibration power level to change a level of vibration of the needle.
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Lo as modified by Boukhny, Brennan and Frankhouser such that in response to at least one of the respective electrical impedances undergoing a change, changing a vibration power level to change a level of vibration of the needle, as taught by Houser, as the references and the claimed invention are directed to ultrasonic surgical systems. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lo as modified by Boukhny, Brennan and Frankhouser with the teachings of Houser by incorporating in response to at least one of the respective electrical impedances undergoing a change, changing a vibration power level to change a level of vibration of the needle in order to expressly control the actuation of the instrument such that increasing power would apply a stronger level of vibration to more effectively cut the tissue (Houser Paragraph 0636).
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lo in view of Boukney, Brennan and Houser et al.
Regarding claim 21, Lo discloses a method, comprising:
vibrating a probe (22) of a phacoemulsification handpiece by driving one or more piezoelectric crystals (28, 30) in the handpiece with one or more electrical signals (electrical driving signals) each having a different respective frequency (Col 2, lines 56-60; Col 9, lines 9-10, 25-35);
inserting the probe into an eye of a patient (the probe encounters liquids in the eye, thus had to have been inserted into the eye of the patient) (Col 7, lines 11-15);
tuning the respective frequency of the electrical signal to one target frequency (mechanical resonant frequency) (Col 6, lines 62-65), measuring respective electrical impedance (load impedance) (Col 2, lines 56-60; Col 12, line 46-51); and
in response to at least one of the measured respective an electrical impedances undergoing a change exceeding a preset impedance change (when phase angle is not 0) (Col 3, lines 66- Col 4, line 4; Col 4, lines 21-28, 42-53; Col 14, lines 11-31), changing a level of vibration of the probe (Col 5, lines 54-61; Col 9 line 67- Col 10, line 5).
Lo fails to explicitly disclose a plurality of respective piezoelectric crystals in the handpiece with a plurality of respective electrical signals, each respective piezoelectric crystal having a different respective frequency; and vibrating a needle of a phacoemulsification handpiece, inserting the needle into an eye of a patient and changing a vibration power level to change a level of vibration of the needle.
However, Boukhny is directed to a phacoemulsification device and teaches a plurality of respective piezoelectric crystals (14) in the handpiece with a plurality of respective electrical signals (longitudinal signal and torsional signal), each respective piezoelectric crystal having a different respective frequency (Paragraph 0019; 0024).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Lo such that a plurality of respective piezoelectric crystals in the handpiece with a plurality of respective electrical signals, each respective piezoelectric crystal having a different respective frequency, as taught by Boukhny, as both references and the claimed invention are directed to phacoemulsification devices. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lo with the teachings of Boukhny by incorporating a plurality of respective piezoelectric crystals in the handpiece with a plurality of respective electrical signals, each respective piezoelectric crystal having a different respective frequency in order to achieve both torsional motion and longitudinal motion (Paragraph 0010).
Furthermore, Brennan et al is directed to a phacoemulsification system and method and teaches a probe comprises a needle (Paragraph 0070).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Lo as modified by Boukhny such that the probe includes a needle, as taught by Brennan, which would then teach vibrating a needle of a phacoemulsification handpiece, inserting the needle into an eye of a patient and changing a level of vibration of the needle as both references and the claimed invention are directed to phacoemulsification. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lo as modified by Boukhny with the teachings of Brennan by incorporating a probe with a needle in order to penetrate the eye during surgery.
Additionally, Houser is directed to an ultrasonic surgical instrument and teaches changing a vibration power level to change a level of vibration of an ultrasonic transducer to control an ultrasonic blade (i.e., needle) in response to measured resonant frequencies (Paragraph 0541; 0635-636). Since Lo uses resonant frequencies to coordinate with changing electrical impedances, the combination would result in in response to at least one of the respective electrical impedances undergoing a change, changing a vibration power level to change a level of vibration of the needle.
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Lo as modified by Boukhny and Brennan such that in response to at least one of the respective electrical impedances undergoing a change, changing a vibration power level to change a level of vibration of the needle, as taught by Houser, as the references and the claimed invention are directed to ultrasonic surgical systems. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lo as modified by Boukhny and Brennan with the teachings of Houser by incorporating in response to at least one of the respective electrical impedances undergoing a change, changing a vibration power level to change a level of vibration of the needle in order to expressly control the actuation of the instrument such that increasing power would apply a stronger level of vibration to more effectively cut the tissue (Houser Paragraph 0636).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZEHRA JAFFRI whose telephone number is (571)272-7738. The examiner can normally be reached 8 AM-5:30 PM.
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/Z.J./Examiner, Art Unit 3771
/SHAUN L DAVID/Primary Examiner, Art Unit 3771
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