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 .
Election/Restrictions
Applicant’s election without traverse of group I in the reply filed on 12/11/2025 is acknowledged.
Claims 16-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/11/2025.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 4/19/2023, 12/20/2023, 7/15/2024, and 12/15/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Specification
The abstract of the disclosure is objected to because:
Line 1 includes a “#”. This appears to be a typo. Examiner suggests deleting the “#”.
The abstract is one long sentence written similar to claim 1. The abstract should be in narrative form. See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts. Examiner suggests restructuring the abstract into several sentences to put the abstract in clearer form.
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claim 4 objected to because of the following informalities:
Line 2 recites “measure IOP”. As antecedent basis has already been provided for the IOP, Examiner suggests replacing “measure IOP” in line 2 of claim 4 with “measure the IOP” to put the claim in clearer form.
Claim 5 objected to because of the following informalities:
Line 4-5 recites “configured at the irrigation channel”. Examiner suggests replacing “configured at the irrigation channel” in line 4-5 of claim 5 with “positioned at the irrigation channel” to put the claim in clearer form as to the position of the pressure sensor.
Claim 6 objected to because of the following informalities:
Line 2 recites “the detected IOP”. Claim 6 depends on claim 3. Claim 3 recites “wherein the circuitry is configured to measure intraocular pressure (IOP)”. As claim 3 uses the term “measure”, not detected, Examiner suggests replacing “the detected IOP” in line 2 of claim 6 with “the measured IOP” to put the claim in clearer form and clearly refer to the IOP of claim 3.
Claim 7 objected to because of the following informalities:
Line 2 recites “0mmHg”. Examiner suggests replacing “0mmHg” in line 7 of claim 7 with “0 mmHg” to put the claim in clearer form.
Claim 9 objected to because of the following informalities:
Line 2 recites “the continuously driven piezoelectric element”. Claim 9 depends on claim 8. Claim 8 recites “to continuously drive the piezoelectric element”. Examiner suggests replacing “the continuously driven piezoelectric element” with “the piezoelectric element while the piezoelectric element is continuously driven” to put the claim in clearer form and clearly refer to the piezoelectric element of claim 8.
Claim 12 objected to because of the following informalities:
Line 2 recites “aspiration module”. As antecedent basis has already been provided for the aspiration module, Examiner suggests replacing “aspiration module” in line 2 of claim 12 with “said aspiration module”.
Line 2 recites “and piezoelectric element”. As antecedent basis has already been provided for the piezoelectric module, Examiner suggests replacing “and piezoelectric module” in line 2 of claim 12 with “and said piezoelectric module”.
Line 3-4 recites “the determination obtained by the circuitry”. Claim 12 depends on claim 1. Claim 1 recites “a determination from the circuitry”. Examiner suggests replacing “the determination obtained by the circuitry” in line 3-4 of claim 12 with “the determination from the circuitry” to put the claim in clearer form and clearly refer to the determination of claim 1.
Claim 14 objected to because of the following informalities:
Line 3 recites “the determination obtained by the circuitry”. Claim 14 depends on claim 1. Claim 1 recites “a determination from the circuitry”. Examiner suggests replacing “the determination obtained by the circuitry” in line 3 of claim 14 with “the determination from the circuitry” to put the claim in clearer form and clearly refer to the determination of claim 1.
Claim 15 objected to because of the following informalities:
Line 2 recites “and vibration of the piezoelectric element”. Examiner suggests replacing “and vibration of the piezoelectric element” with “and a vibration of the piezoelectric element” to put the claim in clearer form by clearly introducing the vibration of the piezoelectric element.
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 4-5, 10-13, and 15 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.
In regard to claim 4,
Line 2 recites “thereto”. It is unclear if thereto refers to the handpiece, to the circuitry, to the system, or to a different structure. For examination purposes Examiner construes “thereto” to be “to the handpiece”. Examiner suggests replacing “thereto” in line 2 of claim 4 with “to the handpiece”.
Examiner notes claim 5 is similarly rejected by virtue of its dependency on claim 4.
In regard to claim 5,
Line 3 recites “an irrigation pump which supplies the irrigation fluid”. It is unclear due to the term “which supplies” if a method step is being claimed. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. See MPEP 2173.05(p). For examination purposes Examiner construes “an irrigation pump which supplies the irrigation fluid” to be “an irrigation pump configured to supply the irrigation fluid”. Examiner suggests replacing “an irrigation pump which supplies the irrigation fluid” in line 3 of claim 5 with “an irrigation pump configured to supply the irrigation fluid”.
In regard to claim 10,
Line 4 recites “the detected electrical impedance”. Line 3 of claim 10 recites “a substantial drop in electrical impedance is detected”. Claim 9, which claim 10 depends on, recites “to measure electrical impedance”. It is unclear if the detected electrical impedance refers to the electrical impedance of line 3 of claim 10 or to the electrical impedance of clam 9. For examination purposes Examiner construes “the detected electrical impedance” to be “the substantial drop in electrical impedance detected”. Examiner suggests replacing “the detected electrical impedance” in line 4 of claim 10 with “the substantial drop in electrical impedance detected”.
In regard to claim 11,
Line 5 recites “irrigation is stopped”. Claim 11 depends on claim 1. Claim 1 introduces an irrigation module and a flow of irrigation fluid, but not an irrigation. It is unclear if the irrigation of claim 11 is intended to refer to an irrigation or the irrigation module or the flow of irrigation fluid. For examination purposes Examiner construes “irrigation” in claim 11 to be “the flow of irrigation fluid”. Examiner suggests replacing “irrigation is stopped” in line 5 of claim 11 with “the flow of irrigation fluid is stopped”.
In regard to claim 12,
Line 1-2 recites “a foot pedal which selectively activates”. It is unclear due to the term “which selectively activates” if a method step is being claimed. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. See MPEP 2173.05(p). For examination purposes Examiner construes “a foot pedal which selectively activates” to be “a foot pedal configured to selectively activate”. Examiner suggests replacing“ a foot pedal which selectively activates” in line 1-2 of claim 12 with “a foot pedal configured to selectively activate”.
Line 3 recites “to control irrigation”. Claim 12 depends on claim 1. Claim 1 introduces an irrigation module and a flow of irrigation fluid, but not an irrigation. It is unclear if the irrigation of claim 12 is intended to refer to an irrigation or the irrigation module or the flow of irrigation fluid. For examination purposes Examiner construes “irrigation” in claim 12 to be “the flow of irrigation fluid”. Examiner suggests replacing “to control irrigation” in line 3 of claim 12 with “to control the flow of irrigation fluid”.
Examiner notes claim 13 is similarly rejected by virtue of its dependency on claim 12.
In regard to claim 13,
Line 3 recites “activates irrigation”. Claim 13 depends on claim 12 and 1. Claim 1 introduces an irrigation module and a flow of irrigation fluid, but not an irrigation. Claim 12 recites “to control irrigation”. It is unclear if the irrigation of claim 13 is intended to refer to an irrigation or the irrigation module or the flow of irrigation fluid or the irrigation of claim 12. For examination purposes Examiner construes “irrigation” in claim 13 to be “the flow of irrigation fluid”. Examiner suggests replacing “activates irrigation” in line 3 of claim 13 with “activates the flow of irrigation fluid”.
Line 1-3 recites “wherein the processor is configured so that when the circuitry determines that the needle is outside the eye, the processor stops the flow of irrigation fluid even if the foot pedal is at a position which activates irrigation”. Claim 13 depends on claim 12. Claim 12 requires “wherein the processor is configured to control irrigation based on the determination obtained by the circuitry in combination with a current foot pedal position”. Claim 13 however implies that regardless of the position of the foot pedal, irrigation is controlled only based on the determination obtained by the circuitry only. Therefore, it does not appear that the foot pedal position is controlling irrigation in claim 13. It is unclear how the processor is both configured to control irrigation based on the determination obtained by the circuitry in combination with a current foot pedal position and configured such that the processor stops the flow of irrigation fluid even if the foot pedal is at a position which activates irrigation. If the position of the foot pedal does not control irrigation in claim 13, it is unclear how the processor would also be configured to control irrigation based on the determination obtained by the circuitry in combination with a current foot pedal position. For examination purposes Examiner construes the processor to be capable of overriding the foot pedal. Examiner suggests amending claim 13 to be dependent on claim 1 and replacing “the foot pedal” with “a foot pedal”.
In regard to claim 15,
Line 2 recites “aspiration”. Claim 15 depends on claim 14 and claim 1. Claim 1 recites “an aspiration module”. It is unclear if the aspiration in claim 15 is intended to refer to an aspiration or the aspiration module. For examination purposes Examiner construes “aspiration” in claim 15 to be “an aspiration”. Examiner suggests replacing “aspiration” in line 2 of claim 15 with “an aspiration”.
Claim Rejections - 35 USC § 102
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 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.
Claims 1 and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Albrecht (U.S. PG publication 20210085522).
In regard to claim 1,
Albrecht discloses a phacoemulsification system (figure 1, item 1; paragraph [0121]), comprising:
a handpiece (figure 1, item 9) comprising a piezoelectric element (figure 1, item 11) and a needle (figure 1, item 12), wherein the needle is configured to be inserted into an eye and to be vibrated by the piezoelectric element to emulsify a lens of the eye (Examiner notes “configured to be inserted into an eye and to be vibrated by the piezoelectric element to emulsify a lens of the eye” is a functional limitation. The needle is fully capable of the recited functions due to its structure as supported by paragraph [0119] and [0121]);
an irrigation module (figure 1, item 6) configured to supply a flow of irrigation fluid into the eye (Examiner notes “configured to supply a flow of irrigation fluid into the eye” is a functional limitation. The irrigation module is fully capable of the recited function due to its structure as supported by paragraph [0119] and [0157]);
an aspiration module (figure 1, item 7) configured for removing material from the eye (Examiner notes “configured for removing material from the eye” is a functional limitation. The aspiration module is fully capable of the recited function as supported by paragraph [0119] and [0157]);
circuitry (evaluation unit 20; paragraph [0027], [0052], [0057], and [0129]) configured to determine whether at least a distal tip of the needle is inside the eye or is outside the eye (Examiner notes “configured to determine whether at least a distal tip of the needle is inside the eye or is outside the eye” is a functional limitation. The circuitry is fully capable of the recited function due to its structure since the circuitry can recognize a normal state in which the needle is outside the eye and no fluid is supplied and can also recognize the state in which the needle has entered the eye and fluid is supplied as supported by paragraph [0029]-[0030] and [0125], [0156]-[0157]; see figure 3A); and
a processor (controller 21; paragraph [0018], [0029]-[0039], [0059], [0131]), which is configured to receive a determination from the circuitry as to whether the distal tip of the needle is inside or outside the eye, and to control operation of at least the irrigation module according to the determination (Examiner notes “configured to receive a determination from the circuitry as to whether the distal tip of the needle is inside or outside the eye, and to control operation of at least the irrigation module according to the determination” is a functional limitation. The processor is fully capable of the recited function as the processor receives a determination via receiver 18a of the pupil size which is indicative to the position of the needle from the circuitry (see paragraph [0128]), and operation of at least the irrigation module is controlled according to the determination (see paragraph [0131] and [0059])).
In regard to claim 14,
Albrecht discloses the system according to claim 1, wherein the processor is configured to control one or both of the piezoelectric element and the aspiration module (aspiration module), in addition to the irrigation module, according to the determination obtained by the circuitry (Examiner notes “configured to control one or both of the piezoelectric element and the aspiration module, in addition to the irrigation module, according to the determination obtained by the circuitry” is a functional limitation. The processor is fully capable of the recited function of controlling the aspiration module, in addition to the irrigation module, according to the determination obtained by the circuitry as supported by paragraph [0136], [0131] and [0059]).
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.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Albrecht (U.S. PG publication 20210085522) and further in view of Hedgeland (U.S. PG publication 20230140303).
In regard to claim 2,
Albrecht discloses the system according to claim 1.
Albrecht is silent as to wherein the processor is configured for at least one of: (i) stopping the flow of irrigation fluid when the circuitry determines that the needle is outside the eye; or (ii) enabling the flow of irrigation fluid only when the circuitry determines that the needle is inside the eye.
Hedgeland teaches wherein the processor is configured for at least one of: (i) stopping the flow of irrigation fluid when the circuitry determines that the needle is outside the eye; or (ii) enabling the flow of irrigation fluid only when the circuitry determines that the needle is inside the eye (paragraph [0053]-[0056]; Examiner notes the processor is configured for enabling the flow of irrigation fluid only when the circuitry determines that the needle is inside the eye as the valve remains closed until the sensor detects the needle is in a certain position within the eye).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the processor of Albrecht to include wherein the processor is configured for at least one of: (i) stopping the flow of irrigation fluid when the circuitry determines that the needle is outside the eye; or (ii) enabling the flow of irrigation fluid only when the circuitry determines that the needle is inside the eye, to include a valve controllable by the processor, and to adjust the valve/processor accordingly to open when the needle has reached the desired position of use in Albrecht, as taught by Hedgeland, for the purpose of ensuring fluid is only delivered when the needle is in a desired position (paragraph [0056] of Hedgeland).
Claims 3-7 are rejected under 35 U.S.C. 103 as being unpatentable over Albrecht (U.S. PG publication 20210085522) and further in view of Heeren (U.S. Patent no 11432961).
In regard to claim 3,
Albrecht discloses the system according to claim 1.
Albrecht is silent as to wherein the circuitry is configured to measure intraocular pressure (IOP).
Heeren teaches wherein the circuitry is configured to measure intraocular pressure (IOP) (column 4, line 36-44 and column 7, line 20-40).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Albrecht to include wherein the circuitry is configured to measure intraocular pressure (IOP) and an IOP sensor, as taught by Heeren, for the purpose of limiting patient risk and allow for better monitoring (column 4, line 2-12 of Heeren).
In regard to claim 4,
Albrecht in view of Heeren teaches the system according to claim 3, wherein the circuitry is configured to measure IOP via at least one sensor incorporated in the handpiece or attached thereto (see analysis of claim 3 above).
In regard to claim 5,
Albrecht in view of Heeren teaches the system according to claim 4, wherein the irrigation module is comprised of: an irrigation channel having an outlet directed into the eye (see figure 1 of Albrecht; paragraph [0119] of Albrecht); an irrigation line extending from the irrigation channel see figure 1 of Albrecht; paragraph [0119] of Albrecht); and an irrigation pump (pump; paragraph [0119]) which supplies the irrigation fluid into the irrigation line (paragraph [0119]); wherein the at least one sensor comprises a pressure sensor configured at the irrigation channel, adjacent the outlet (see figure 1 of Heeren and analysis of claim 4 and 3 above).
In regard to claim 6,
Albrecht in view of Heeren teaches the system according to claim 3, wherein the processor is configured to stop the flow of irrigation fluid when the detected IOP is within a predefined range for a minimal predefined period of time (column 11, line 20-42).
In regard to claim 7,
Albrecht in view of Heeren teaches the system according to claim 6.
Albrecht in view of Heeren is silent as to wherein the predefined range is between 0mmHg +/- 15 mmHg and the minimal predefined period of time is 250 msec.
It would have been an obvious matter of design choice to modify Albrecht in view of Heeren to include wherein the predefined range is between 0mmHg +/- 15 mmHg and the minimal predefined period of time is 250 msec since applicant has not disclosed that having wherein the predefined range is between 0mmHg +/- 15 mmHg and the minimal predefined period of time is 250 msec solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. Furthermore, absent a teaching as to the criticality of wherein the predefined range is between 0mmHg +/- 15 mmHg and the minimal predefined period of time is 250 msec, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975). Page 12, line 13-15 of the instant disclosure supports that the time period can be longer or shorter. Page 13, line 11-13 also supports the range can be higher or lower.
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Albrecht (U.S. PG publication 20210085522) and further in view of Urich (U.S. PG publication 20210196515).
In regard to claim 8,
Albrecht discloses the system according to claim 1.
Albrecht is silent as to wherein the processor is configured to continuously drive the piezoelectric element at non-therapeutic settings when not emulsifying the lens.
Urich teaches wherein the processor is configured to continuously drive the piezoelectric element at non-therapeutic settings when not emulsifying the lens (paragraph [0066], [0070]-[0071]; Examiner notes “configured to continuously drive the piezoelectric element at non-therapeutic settings when not emulsifying the lens” is a functional limitation. The processor is fully capable of the recited function due to the fact that the vibration frequency can be adjusted as supported by paragraph [0066], [0070]-[0071]. Examiner further notes claim 8 does not specify the system is within the eye, the processor could be configured to continuously drive the piezoelectric element at non-therapeutic settings when not emulsifying the lens when the system is outside of the eye for example and therefore not emulsifying the lens).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the processor of Albrecht to include wherein the processor is configured to continuously drive the piezoelectric element at non-therapeutic settings when not emulsifying the lens, as taught by Urich, for the purpose of removing cataracts more efficiently (paragraph [0071] of Urich).
In regard to claim 9,
Albrecht in view of Urich teaches the system according to claim 8.
Albrecht in view of Urich is silent as to wherein the circuitry is configured to measure electrical impedance of the continuously driven piezoelectric element.
Urich teaches wherein the circuitry is configured to measure electrical impedance of the continuously driven piezoelectric element (paragraph [0040]; Examiner notes “configured to measure electrical impedance of the continuously driven piezoelectric element” is a functional limitation. The circuitry is fully capable of the recited function due to its structure as supported by paragraph [0040]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Albrecht in view of Urich to include wherein the circuitry is configured to measure electrical impedance of the continuously driven piezoelectric element, as taught by Urich, for the purpose of providing feedback to enable adjustments (paragraph [0040] of Urich).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Albrecht (U.S. PG publication 20210085522) in view of Urich (U.S. PG publication 20210196515) further in view of Hedgeland (U.S. PG publication 20230140303).
In regard to claim 10,
Albrecht in view of Urich teaches the system according to claim 9.
Albrecht in view of Urich fails to disclose wherein the processor is configured to stop the flow of irrigation fluid when: a. a substantial drop in electrical impedance is detected and/or b. the detected electrical impedance is lower than a preset threshold.
Hedgeland teaches wherein the processor is configured to stop the flow of irrigation fluid when: a. a substantial drop in electrical impedance is detected and/or b. the detected electrical impedance is lower than a preset threshold (Examiner notes “wherein the processor is configured to stop the flow of irrigation fluid when: a. a substantial drop in electrical impedance is detected and/or b. the detected electrical impedance is lower than a preset threshold” is a functional limitation. The processor is fully capable of the recited function as supported by paragraph [0078] wherein impedance is tracked rather than voltage, paragraph [0074]-[0077]: wherein the position of the needle is determined and when the needle is in contact with the eye a response module is activated; paragraph [0056] and [0077] wherein the response module includes a valve that is closed until the correct position of the needle is detected based on a high enough value. Therefore, the processor is configured to stop the flow of irrigation fluid by closing the valve when the detected electrical impedance is lower than a preset threshold).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the processor of Albrecht to include wherein the processor is configured to stop the flow of irrigation fluid when: a. a substantial drop in electrical impedance is detected and/or b. the detected electrical impedance is lower than a preset threshold, to include a valve controllable by the processor, and to adjust the valve/processor accordingly to open or close based on the position in Albrecht, as taught by Hedgeland, for the purpose of ensuring fluid is only delivered when the needle is in a desired position (paragraph [0056] of Hedgeland).
Claims 11 are rejected under 35 U.S.C. 103 as being unpatentable over Albrecht (U.S. PG publication 20210085522) further in view of Heeren (U.S. Patent no 11432961) further in view of Hedgeland (U.S. PG publication 20230140303).
In regard to claim 11,
Albrecht discloses the system according to claim 1.
Albrecht is silent as to wherein the processor is configured to operate the irrigation module and the aspiration module according to a stabilizing mode in which IOP levels are maintained within prespecified safe limits; wherein the processor is further configured so that even in said stabilizing mode, if a determination from the circuitry that the distal tip of the needle is outside the eye is received, irrigation is stopped.
Heeren teaches wherein the processor is configured to operate the irrigation module and the aspiration module according to a stabilizing mode in which IOP levels are maintained within prespecified safe limits (column 11, line 20-column 12, line 10; Examiner notes “configured to operate the irrigation module and the aspiration module according to a stabilizing mode in which IOP levels are maintained within prespecified safe limits, as taught by Heeren, for the purpose of avoiding over pressurization of the eye” is a functional limitation. The processor is fully capable of recited function due to its structure as supported by column 11, line 20-column 12, line 10).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Albrecht to include wherein the processor is configured to operate the irrigation module and the aspiration module according to a stabilizing mode in which IOP levels are maintained within prespecified safe limits, as taught by Heeren, for the purpose of avoiding over pressurization of the eye (column 12, line 3-10 of Heeren).
Albrecht in view of Heeren fails to disclose wherein the processor is further configured so that even in said stabilizing mode, if a determination from the circuitry that the distal tip of the needle is outside the eye is received, irrigation is stopped.
Hedgeland teaches wherein the processor is further configured so that even in said stabilizing mode (mode when fluid is delivered), if a determination from the circuitry that the distal tip of the needle is outside the eye is received, irrigation is stopped (paragraph [0053]-[0056]) and [0074]-[0077]; Examiner notes “configured so that even in said stabilizing mode, if a determination from the circuitry that the distal tip of the needle is outside the eye is received, irrigation is stopped” is a functional limitation. The processor is fully capable of the recited function as a valve can be closed to stop irrigation depending on the position of the needle relative to the eye).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Albrecht in view of Heeren to include wherein the processor is further configured so that even in said stabilizing mode, if a determination from the circuitry that the distal tip of the needle is outside the eye is received, irrigation is stopped, and to include a valve controllable by the processor, and to adjust the valve/processor accordingly to open or close based on the position in Albrecht as taught by Hedgeland, for the purpose of ensuring fluid is only delivered when the needle is in a desired position (paragraph [0056] of Hedgeland).
Claims 12 are rejected under 35 U.S.C. 103 as being unpatentable over Albrecht (U.S. PG publication 20210085522) and further in view of Kadziauskas (U.S. PG publication 20060195077).
In regard to claim 12,
Albrecht system according to claim 1, further comprising a foot pedal (figure 1, item 22), wherein the processor is configured to control irrigation based on the determination obtained by the circuitry in combination with a current foot pedal position (paragraph [0120] and paragraph [0131] and [0059]; Examiner notes “configured to control irrigation based on the determination obtained by the circuitry in combination with a current foot pedal position” is a functional limitation. The processor is fully capable of the recited function due to its structure and its function/communication with the foot pedal).
Albrecht is silent as to further comprising a foot pedal which selectively activates said irrigation module, aspiration module and piezoelectric element via a plurality of foot pedal positions.
Kadziauskas teaches further comprising a foot pedal which selectively activates said irrigation module, aspiration module and piezoelectric element via a plurality of foot pedal positions (paragraph [0106]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the foot pedal of Albrecht to include a foot pedal which selectively activates said irrigation module, aspiration module and piezoelectric element via a plurality of foot pedal positions, as taught by Kadziauskas, for the purpose of enabling desired control of the system (paragraph [0106] of Kadziauskas).
Claims 13 are rejected under 35 U.S.C. 103 as being unpatentable over Albrecht (U.S. PG publication 20210085522) in view of Kadziauskas (U.S. PG publication 20060195077) further in view of Hedgeland (U.S. PG publication 20230140303) and further in view of Heeren (U.S. Patent no 11432961).
In regard to claim 13,
Albrecht in view of Kadziauskas teaches the system according to claim 12.
Albrecht in view of Kadziauskas wherein the processor is configured so that when the circuitry determines that the needle is outside the eye, the processor stops the flow of irrigation fluid even if the foot pedal is at a position which activates irrigation.
Hedgeland teaches wherein the processor is configured so that when the circuitry determines that the needle is outside the eye, the processor stops the flow of irrigation fluid (paragraph [0053]-[0056]) and [0074]-[0077]; Examiner notes “configured so that when the circuitry determines that the needle is outside the eye, the processor stops the flow of irrigation fluid” is a functional limitation. The processor is fully capable of the recited function as a valve can be closed to stop irrigation depending on the position of the needle relative to the eye).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Albrecht in view of Kadziauskas to include wherein the processor is configured so that when the circuitry determines that the needle is outside the eye, the processor stops the flow of irrigation fluid and to include a valve controllable by the processor, and to adjust the valve/processor accordingly to open or close based on the position in Albrecht, as taught by Hedgeland, for the purpose of ensuring fluid is only delivered when the needle is in a desired position (paragraph [0056] of Hedgeland).
Albrecht in view of Kadziauskas in view of Hedgeland is silent as to the processor stops the flow of irrigation fluid even if the foot pedal is at a position which activates irrigation.
Heeren teaches the processor stops the flow of irrigation fluid even if the foot pedal is at a position which activates irrigation (column 11, line 35-42).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the foot pedal of Albrecht in view of Kadziauskas in view of Hedgeland to be capable of being overridden by the processor to stop the flow of irrigation fluide and therefore include the processor stops the flow of irrigation fluid even if the foot pedal is at a position which activates irrigation, as taught by Heeren, therefore resulting in wherein the processor is configured so that when the circuitry determines that the needle is outside the eye, the processor stops the flow of irrigation fluid even if the foot pedal is at a position which activates irrigation for enabling the foot pedal to be overridden depending on the condition of the system (column 11, line 35-42 of Heeren).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Albrecht (U.S. PG publication 20210085522) and further in view of Kraemer (U.S. PG publication 20170246036).
In regard to claim 15,
Albrecht discloses the system according to claim 14.
Albrecht is silent as to wherein the processor is configured to stop one or both of aspiration and vibration of the piezoelectric element when the circuitry determines that the needle is outside the eye.
Kraemer teaches wherein the processor is configured to stop the element used to break up a cataract when the circuitry determines that the needle is outside the eye (paragraph [0047]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the processor and piezoelectric element of Albrecht which is vibrated/used to break up a cataract to include wherein the processor is configured to stop one or both of aspiration and vibration of the piezoelectric element when the circuitry determines that the needle is outside the eye and to include a sensor to sense position of the tip relative to the eye, as taught by Kraemer, therefore resulting in wherein the processor is configured to stop one or both of aspiration and vibration of the piezoelectric element when the circuitry determines that the needle is outside the eye for the purpose of avoiding tissue damage (paragraph [0047] of Kraemer).
Conclusion
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/ALEXANDRA LALONDE/ Examiner, Art Unit 3783 /KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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