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 office action is responsive to the amendment filed on June 18, 2024. As directed by the amendment: claims 1, 6, 8 and 10 have been amended, claims 11-15 have been cancelled, and claims 16-20 have been added. Thus, claims 1-10 and 16-20 are presently pending in this application.
Claim Objections
Claim 18 is objected to because of the following informalities: insert “to” between “response one” in line 1. 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.
Claims 1-5, 7 and 17-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Boukhny et al. (Boukhny) US 2011/0015563 A1.
Regarding claim 1, Boukhny discloses a phacoemulsification system for optimizing phaco energy setpoints during phacoemulsification surgery (P0050-0066, Figs. 2-6), the system comprising: a surgical console (control console 114, P0046) having a processor (CPU 116, P0046) configured to determine a phaco energy baseline setpoint (power delivered to the cutting tip of the ultrasound handpiece, step 430 P0051 and shown in Fig. 4) wherein the phaco energy baseline setpoint is based on one or more values (operating parameters can be aspiration vacuum and/or irrigation pressure, P0051) recorded in response to one or more prior occlusion breaks (initially, a pattern of surgical operating parameters during an occlusion is detected over time P0051, and it has been determined that these surgical operating parameters follow a detectable pattern, see Fig. 6, that can be used to identify a stage of occlusion including a break 530, and adjust power accordingly P0052), and wherein the phaco energy baseline setpoint is a phaco energy setting amount (power delivered to the handpiece 112, P0052); and at least one vacuum source (vacuum 118, P0046) associated with the surgical console for providing a vacuum pressure and at least one energy source (power supply 120, P0046) associated with the surgical console for providing ultrasonic energy based on the determined phaco energy baseline setpoint (P0052).
Regarding claim 2, Boukhny discloses the system of claim 1, wherein each of the occlusion breaks is recorded as a lens emulsifying condition (each occlusion break is recorded as a lens emulsifying condition because the lens is cut).
Regarding claim 3, Boukhny discloses the system of claim 1, wherein the one or more values are based on occlusion breaks occurring during a single surgical procedure (the operating parameters including aspiration vacuum and/or irrigation pressure based occlusion breaks 530 include occlusion breaks occurring during a single surgical procedure).
Regarding claim 4, Boukhny discloses the system of claim 1, wherein the one or more values are based on occlusion breaks occurring over a plurality of surgical procedures (pattern of detected events over time, P0051).
Regarding claim 5, Boukhny discloses the system of claim 1, wherein the one or more values are based on estimated values for occlusion breaks occurring during a plurality of surgical procedures (the operating parameters including aspiration vacuum and/or irrigation pressure based occlusion breaks 530 include occlusion breaks occurring during a single surgical procedure in addition to other surgical procedures thus forming a pattern of detected events over time, P0051).
Regarding claim 7, Boukhny discloses the system of claim 1, wherein a deviation value is determined based on the one or more values (P0060-0061 describes determining a phase of occlusion by calculating a correlation between the pre-defined pattern and the actual sensor readings, wherein a correlation of less than 1 is a deviation value).
Regarding claim 17, Boukhny discloses the system of claim 1, further comprising a memory coupled with the processor (control system memory, P0092), wherein the memory is configured to store one or more of the values recorded in response to one or more occlusion breaks and the determined phaco energy baseline setpoint (the memory is fully capable of storing one or more of the values recorded in response to one or more occlusion breaks and the determined phaco energy baseline setpoint).
Regarding claim 18, Boukhny discloses the system of claim 17, wherein the values recorded in response to one or more occlusion breaks comprise at least one selected from the group consisting of a vacuum level (vacuum level, P0050).
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.
Claims 6 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Boukhny.
Regarding claim 6, Boukhny discloses the system of claim 1.
Boukhny teaches adjusting the power level according to detected changes in vacuum and irrigation pressure levels that correlate with occlusion event stages, but does not explicitly teach wherein the phaco energy baseline setpoint decreases in response to an excess energy condition.
Boukhny teaches that excess power can burn tissue P0008, and one of ordinary skill in the art would recognize that adjusting the power level includes increasing as well as decreasing the power. It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to decrease power in response to an excess energy condition that exists at occlusion breaks to prevent or minimize damage to the eye.
Regarding claim 16, Boukhny discloses the system of claim 1.
Boukhny teaches adjusting the power level according to detected changes in vacuum and irrigation pressure levels that correlate with occlusion event stages, but does not teach wherein a duration of providing ultrasonic energy based on the determined phaco energy baseline setpoint begins at a first time point and ends at a second time point, wherein the first time point is during an occlusion and the second time point is when an occlusion break is detected.
However, Boukhny teaches adjusting power based on load Fig. 11, and decreasing power to minimize heat damage to the eye Fig. 7. It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to apply ultrasonic energy for the duration as claimed for the purpose of breaking an occlusion and then minimizing heat damage to the eye.
Claims 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Boukhny in view of Nixon US 2010/0118266 A1.
Regarding claim 19, Boukhny discloses the system of claim 18.
Boukhny does not teach wherein the phaco energy baseline setpoint is further based on one or more selected from the group consisting of surgeon-specific data inputs and cataract grade.
However, Nixon teaches a system for grading a cataract wherein pre-operative grading allows for the pre-programming of cataract surgical equipment to ideally match a grade of the cataract to an appropriate energy setting and fluid setting to most efficiently remove the cataract, P0003.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to further base the phaco energy baseline setpoint on cataract grade as taught by Nixon for the purpose of providing appropriate energy settings and fluid settings to most efficiently remove the cataract, Nixon P0003.
Regarding claim 20, Boukhny in view of Nixon teach the system of claim 19.
Boukhny in view of Nixon do not explicitly wherein surgeon-specific data inputs are selected from the group consisting of vacuum rate, flow rate, pump type, pump speed, ultrasonic power type, ultrasonic power duration, irrigation source height, tip size, sleeve size, irrigation tube length, and aspiration tube length.
However, Nixon teaches grading a cataract to provide appropriate energy settings and fluid settings to most efficiently remove the cataract P0003. It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the surgeon to input the energy and fluid settings based on cataract grade to improve the efficiency of the cataract removal.
Allowable Subject Matter
Claims 8-10 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: the claims in this application are allowable because the prior art of record fails to disclose either singularly or in combination the claimed phacoemulsification system.
The closest prior art is Boukhny et al. (Boukhny) US 2011/0015563 A1.
Regarding claim 8, Boukhny fails to teach among all the limitations or render obvious a phacoemulsification system as claimed, which includes wherein the phaco energy baseline setpoint is determined by subtracting the deviation value from a lifetime occlusion break value, in combination with the total structure and function of the phacoemulsification system as claimed.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN A DOUBRAVA whose telephone number is (408)918-7561. The examiner can normally be reached M-F 9-5 Pacific Time.
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/J.A.D./Examiner, Art Unit 3783 /James D Ponton/Primary Examiner, Art Unit 3783
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