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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/29/26 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Amendment
The amendment filed 02/03/26 has been entered. Claims 1, 5, 9, and 11 have been amended. Claims 2-4, 6-8, 10, and 12 are in the original/ previously presented form. Thus, claims 1-12 remain pending in the application. Applicant’s amendments to the Claims have overcome each and every 112(a) new matter and 112(b) rejection previously set forth in the Non-Final Office Action mailed 11/06/25. However, new issues have been introduced by the amendment filed 02/03/26 (see 112 rejections below).
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 lines 18-19 read “by a pressure sensor” and should likely read “by [[a]] the pressure sensor” since “a pressure sensor” has already been introduced in the claim language
Appropriate correction is required.
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.
Claims 1-12 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.
Regarding claim 1, lines 17-19 reciting “an early indication of a drop in the IOP below a prespecified limit prior to detection of the drop in the IOP below the prespecified limit by a pressure sensor” appear to introduce new matter that affects the scope of the claims. The limitation that some early indication of a drop in the IOP occurs “prior to” a detection by the pressure sensor does not appear to be supported by Applicant’s original disclosure. For example, in the current Application’s PGPUB, Applicant discloses that the processor controls the pump to maintain the IOP within prespecified limits based on the pressure sensor, vacuum sensor, or both per the cited areas below:
see [0024],
[0028-0029],
[0039-0040],
[0049],
[0055]: “Using the early indication (e.g., at least one of readings (230, 270)), processor 38 calculates required changes in rates of pumps 24 and 26, and using the feedback loop that receives the early indication (e.g., feedback signals), processor 38 commands pumps 24 and 26 to adjust pump rates such that readings (230 and 270), indicative of the IOP, are maintained within prespecified limits, at pumps control step 108.”,
[0057],
[0063], and
[0069]: processor 38 receives pressure crystal's 55 electrical impedance readings (402) from crystal 55, which early-indicate (e.g., within several mSec) a risk of a change (e.g. drop) in IOP that is above or below a prespecified limit or outside a prespecified range, at a risk of IOP change indication receiving step 506.
Although [0055] and [0069] disclose early indication detection by the electrical impedance, there is no disclosure supporting that this detection occurs prior to the sensor reading from the pressure sensor. Therefore, none of these paragraphs disclose that an early indication is occurring “prior to” a detection by the pressure sensor.
Therefore, because there does not appear to be a figure or paragraph from the original disclosure to support this amended claim limitation in claim 1, new matter has been introduced that affects the scope of the claims (see MPEP § 608.04(a): new matter rejections should be made when the scope of the claim is modified by the amendment).
Due to claim dependency from claim 1, claims 2-4 and 9-10 are subsequently rejected under 112a.
Regarding claim 5, lines 10-12 reciting “an early indication of a drop in an intraocular pressure (IOP) below a prespecified limit prior to detection, based on at least one pressure measurement, of the drop in IOP below the prespecified limit” appear to introduce new matter that affects the scope of the claims (similar to the reasons presented for the new matter introduced in claim 1). Therefore, because there does not appear to be a figure or paragraph from the original disclosure to support this amended claim limitation in claim 5, new matter has been introduced that affects the scope of the claims (see MPEP § 608.04(a): new matter rejections should be made when the scope of the claim is modified by the amendment).
Due to claim dependency from claim 5, claims 6-8 and 11-12 are subsequently rejected under 112a.
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 1-12 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.
Regarding claim 1, lines 17-19 recite “an early indication of a drop in the IOP below a prespecified limit prior to detection of the drop in the IOP below the prespecified limit by a pressure sensor”. However, in view of Applicant disclosure, it is unclear to the examiner how and early indication of a drop in IOP occurs “prior to” detection of the drop by the pressure sensor (see 112a rejection above for further explanation).
Therefore, for purposes of examination and to best align with Applicant disclosure (such as at least [0055] and [0069] of the current Application’s PGPUB), the examiner interprets that any processor configured to detect a drop in IOP by both the impedance and pressure sensors meets the limitation as claimed, according to as much that is disclosed by Applicant.
Due to claim dependency from claim 1, claims 2-4 and 9-10 are subsequently rejected under 112b.
Regarding claim 5, lines 10-12 recite “an early indication of a drop in an intraocular pressure (IOP) below a prespecified limit prior to detection, based on at least one pressure measurement, of the drop in IOP below the prespecified limit”. However, in view of Applicant disclosure, it is unclear to the examiner how and early indication of a drop in IOP occurs “prior to” detection of the drop by the pressure sensor (see 112a rejection above for further explanation and 112b rejection of claim 1 above).
Therefore, for purposes of examination and to best align with Applicant disclosure (such as at least [0055] and [0069] of the current Application’s PGPUB), the examiner interprets that any processor configured to detect a drop in IOP by both the impedance and pressure sensors meets the limitation as claimed, according to as much that is disclosed by Applicant.
Due to claim dependency from claim 5, claims 6-8 and 11-12 are subsequently rejected under 112b.
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.
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 1-4 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Shelton, IV et al. (U.S. PGPUB No. 2019/0059980), hereinafter Shelton, in view of Sorensen et al. (U.S. PGPUB No. 2014/0323953), hereinafter Sorensen.
Regarding claim 1, Shelton discloses a surgical system (see FIG. 2 and [0080]: surgical system with tool 300), comprising:
an irrigation channel (310) for receiving irrigation fluid (324: fluid from fluid source, see [0084]: fluid sources described and provided via peristaltic pump in housing 302) from an irrigation line (311); and
an aspiration channel (312) for removing material and evacuating the removed material to an aspiration line (312p, see FIG. 2, [0082], and [0085]);
an irrigation pump (1111, see FIG. 11 and [0138]: 1111 is peristaltic pump for providing fluid via irrigation line) coupled with the irrigation line (311, see [0084]: fluid provided to tool by peristaltic pump in housing 302);
an aspiration pump (1134, see FIG. 11 and [0138]: pump 1134 for delivering vacuum force to aspiration line) coupled with the aspiration line (312p);
circuitry (see FIG. 11) configured to measure an electrical impedance (Z, see FIG.11) of a piezoelectric crystal (see [0139]: circuitry measures impedance and therefore is configured to measure an electrical impedance from any structural element such as a piezoelectric crystal);
a processor (PID controller 1150), which is configured to receive the measured electrical impedance (see arrow in FIG. 11 showing PID controller receives impedance, Z, and [0139]);
the processor (1150) configured to detect, based on the measured electrical impedance of the piezoelectrical crystal (see FIG. 11 and [0139]. Because the processor measures electrical impedance, the processor is configured to detect, based on an a measured electrical impedance from any structural element such as a piezoelectric crystal) a drop in pressure below a prespecified limit (see FIG. 12 and [0145-0146]: system detects ΔP/ a drop in pressure as in FIG.12c based on change in impedance, see FIG.12b, [0149]: thresholds set for specific procedure or tissue area, and [0152]: adjusting based on impedance below a prespecified limit.);
the processor (1150) configured to, in response to detecting the drop in pressure below the prespecified limit (see at least FIG. 12, [0145-0146], [0149], and [0152]), calculate, based on the measured electrical impedance (see [0137]: control system for controlling both the flow rate of irrigation fluid and vacuum rate of aspiration. see [0139-0140]: all calculations stem from received impedance value Z. In [0139]: Z results in calculated ΔP for control of aspiration line. see [0140]: ΔP is used to calculate Q for flow rate in the irrigation line. see [0143] and [0147]: pumps responsive to measured impedance values), a required change in a rate of the irrigation pump (1111, see FIG. 11 and [0139-0140]) and a required change in a rate of the aspiration pump (1134, see FIG. 11 and [0139-0140]), wherein the required change in the rate of the irrigation pump and the required change in the rate of the aspiration pump (see [0139-0140]) are calculated to cause a subsequent measurement of the electrical impedance to fall within a prespecified range (see FIG. 12 and [0145-0146]: system detects ΔP/ a drop in pressure as in FIG.12c based on change in impedance, see FIG.12b, [0149]: thresholds set for specific procedure or tissue area, [0152]: adjusting based on impedance below a prespecified limit, and [0137], [0139-0140], [0143], & [0147] for changing the pumping rate to maintain limits—all limits based on measured impedance of system); and
the processor (1150, see FIG. 11) configured to adjust an operation (see flow rate Q in FIG. 12) of the irrigation pump (1111) in accordance with the required change in the rate of the irrigation pump (1111, see [0137-0147]) and to adjust an operation (see aspiration rate in FIG. 12) of the aspiration pump (1134) in accordance with the required change in the rate of the aspiration pump (1134, see [0137-0147]),
wherein the required change in the rate of the irrigation pump and the required change in the rate of the aspiration pump are calculated to cause the pressure to remain above the prespecified limit (see [0137-0147], specifically [0143]: ΔP is pressure differential over time based on controlled aspiration pump rate. therefore, the changes to the system ultimately cause the pressure to remain above the required prespecified limit. Prespecified limit logic also shown by flowchart in FIG. 11 and controller logic in FIG. 10).
Shelton is silent to the surgical system being specifically a “phacoemulsification” system comprising “a phacoemulsification probe, comprising: a piezoelectric crystal configured to vibrate at a mechanical resonance frequency of the crystal; a needle, which is configured to be inserted into a lens capsule of an eye and to be vibrated by the piezoelectric crystal to emulsify a lens of the eye”, “flowing the irrigation fluid into the lens capsule”, and removing material “from the lens capsule” to the aspiration line, “a pressure sensor configured to measure an intraocular pressure (IOP)”, the processor configured to detect, based on the measured electrical impedance of the piezoelectric crystal, “an early indication of a drop in the IOP” below a prespecified limit, “prior to detection of the drop in the IOP below the prespecified limit by a pressure sensor;”, the processor calculation being in response to detecting “the early indication of the drop in the IOP” below the prespecified limit, and the change in the rates of the pumps being specifically to cause the “IOP” pressure to remain above the prespecified limit.
However, Sorensen teaches a phacoemulsification system (see FIG. 1 and [0024]), comprising: a phacoemulsification probe (112, see FIG. 3 for all other reference numerals unless otherwise noted), comprising:
a piezoelectric crystal configured to vibrate at a mechanical resonance frequency of the crystal (see [0004]: operative portion has piezoelectric crystals for supplying ultrasonic vibration and therefore is “configured to vibrate” at a mechanical resonance frequency);
a needle (see [0026]: a cutting needle of the handpiece 112), which is configured to be inserted into a lens capsule of an eye and to be vibrated by a piezoelectric crystal to emulsify a lens of the eye (see [0026]: ultrasonic oscillation, by piezoelectric crystal see [0004], to operate cutting needle and [0005]: vibrating needle emulsifies lens of eye.),
an irrigation channel (320) for receiving irrigation fluid (see [0028]: irrigation fluid from fluid source 310) from an irrigation line (315) and flowing the irrigation fluid into the lens capsule (see [0006]);
an aspiration channel (325) for removing material and evacuating the removed material (see [0029-0030]) to an aspiration line (305);
a pressure sensor (330) configured to measure an intraocular pressure (IOP) (see [0031-0035]);
circuitry (see [0031]: controller formed of a processor and a memory and therefore the system includes “circuitry”) configured to measure a pressure (see [0033]: controller 360, part of circuitry, receives information from pressure sensor);
a processor (360), which is configured to receive the measured pressure (see [0033]);
the processor (360) configured to detect, based on the measured pressure an early indication (see [0033]: pressure detection & response occur within 50milliseconds, aligning with Applicant disclosure in [0055]: “early” indication is feedback within several mSec) of a drop in the IOP below a prespecified limit (see [0032]: one or more pressure thresholds can be established, such as a minimum operating pressure and [0033]: pressure used to inform drop in IOP);
the processor (360) configured to, in response to detecting the early indication of the drop in the IOP below the prespecified limit (see [0032-0033]), calculate a required change in the system to cause the IOP pressure to remain above the prespecified limit (see [0031-0038]: system calculates degree of valve opening to maintain IOP within prespecified limits. See also FIG. 4 and [0040-0044] for algorithm/decision logic description).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the surgical system with a surgical tool comprising controlled aspiration and irrigation rates based on measured impedance disclosed in Shelton to be formed as a phacoemulsification surgical system comprising a phacoemulsification probe as taught by Sorensen for the purpose of adapting the surgical system with controlled irrigation and aspiration rates for use in a phacoemulsification surgical procedure requiring a manually operated handpiece surgical tool with varying flow rates (see [0003-0008]), thus achieving the surgical system being specifically a “phacoemulsification” system comprising “a phacoemulsification probe, comprising: a piezoelectric crystal configured to vibrate at a mechanical resonance frequency of the crystal; a needle, which is configured to be inserted into a lens capsule of an eye and to be vibrated by the piezoelectric crystal to emulsify a lens of the eye”, “flowing the irrigation fluid into the lens capsule”, and removing material “from the lens capsule” to the aspiration line.
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system and processor configured to detect, measure, and maintain the system pressure, via impedance, within prespecified limits by modifying system pumping rates disclosed in Shelton to include a pressure sensor to detect IOP and use the processor to specifically maintain an intraocular pressure as taught by Sorensen for the purpose of adapting the surgical system for use in a phacoemulsification procedure that has varying flow rates resulting in varying pressure losses and occlusions that must be monitored and maintained for procedure efficacy (see [0007-0009] and [0024]), thus achieving “a pressure sensor configured to measure an intraocular pressure (IOP)”, the processor configured to detect, based on the measured electrical impedance of the piezoelectric crystal, “an early indication of a drop in an intraocular pressure (IOP)” below a prespecified limit, “prior to detection of the drop in the IOP below the prespecified limit by a pressure sensor;” (Shelton in view of Sorensen now includes both the pressure and impedance measurements monitored by the processor and therefore meet this limitation as interpreted under 112b above) the processor calculation being in response to detecting “the early indication of the drop in the IOP” below the prespecified limit, and the change in the rates of the pumps being specifically to cause the “IOP” pressure to remain above the prespecified limit.
Regarding claim 2, the modified system of Shelton teaches the phacoemulsification system according to claim 1, and Shelton further discloses wherein the processor (1150, see FIG. 11) is configured to control the operation of the irrigation pump (1111) and to control the operation of the aspiration pump (1134) by operating the irrigation pump and the aspiration pump simultaneously (see FIG. 12: all operations controlled with the same time axis. And [0139], [0143], and [0145-0147]).
Regarding claim 3, the modified system of Shelton teaches the phacoemulsification system according to claim 1, and Shelton further discloses wherein the processor (1150, see FIG. 11) is configured to control at least one of an irrigation flow rate or an aspiration flow rate by operating a valve coupled with at least one of the irrigation line and the aspiration line (see [0089],[0099]: a valve is provided in the housing at the vacuum source==coupled with aspiration line and is “actuated” to control aspiration of fluids and [0137-0147]: the processor controls the irrigation and aspiration flow rates. Therefore, the processor is configured to control the aspiration rate by operating a valve coupled with the aspiration line.).
Regarding claim 4, the modified system of Shelton teaches the phacoemulsification system according to claim 1, and Shelton further discloses wherein the processor (1150, see FIG. 11) is configured to control at least one of an irrigation flow rate or an aspiration flow rate by operating a valve coupled with at least one of an irrigation channel and an aspiration channel (see [0089],[0099]: a valve is provided in the housing at the vacuum source==coupled with aspiration channel and is “actuated” to control aspiration of fluids and [0137-0147]: the processor controls the irrigation and aspiration flow rates. Therefore, the processor is configured to control the aspiration rate by operating a valve coupled with the aspiration channel).
Regarding claim 10, the modified system of Shelton teaches the phacoemulsification system according to claim 1, and Shelton further discloses further comprising at least one of a first valve coupled with the irrigation line or a second valve coupled with the aspiration line (see [0089],[0099]: a valve is provided in the housing at the vacuum source==coupled with aspiration line and is “actuated” to control aspiration of fluids), the processor further configured to control at least one of the first valve or the second valve (see [0089] & [0099]: valve actuation and [0137-0147]: controlling flow rates)
Shelton is silent to the processor further configured to control at least one of the first valve or the second valve “in response to detecting the early indication of the drop in the IOP below the prespecified limit”.
However, Sorensen teaches a phacoemulsification system (see FIG. 1 and [0024]), comprising: a phacoemulsification probe (112, see FIG. 3 for all other reference numerals unless otherwise noted), comprising a processor (360) configured to detect, based on the measured pressure an early indication (see [0033]: pressure detection & response occur within 50milliseconds, aligning with Applicant disclosure in [0055]: “early” indication is feedback within several mSec) of a drop in an intraocular pressure (IOP) below a prespecified limit (see [0032]: one or more pressure thresholds can be established, such as a minimum operating pressure and [0033]: pressure used to inform drop in IOP);, the processor further configured to control at least one of a first valve or a second valve (350, vacuum relief valve 350 on aspiration line as seen in FIG. 3 and [0029]. See [0031-0038] and FIG.4 for processor control of valve 350) in response to detecting the early indication of the drop in the IOP below the prespecified limit (see [0032-0033]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the processor coupled with and controlling the valve disclosed in Shelton to control the valve in response to the early indication of the drop in the IOP below the prespecified limit as taught by Sorensen for the purpose of determine and respond to an event in which an occlusion break has occurred (see [0041]), which is critical to the efficacy of the phacoemulsification procedure (see [0024]), thus achieving the processor further configured to control at least one of the first valve or the second valve “in response to detecting the early indication of the drop in the IOP below the prespecified limit”.
Claims 5-6 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Boukhny et al (U.S. PGPUB No. 2018/0318131), hereinafter Boukhny, in view of Kadziauskas et al. (U.S. PGPUB No. 2006/0195077), hereinafter Kad.
Regarding claim 5, Boukhny discloses a method, comprising:
inserting into an eye (1145, see Fig. 1 and [0005]) a phacoemulsification probe (1150, see [0024]) comprising a needle (see [0004-0005]), an irrigation channel (see [0025]: where irrigation fluid flows from irrigation line through hand piece), and an aspiration channel (see [0024]: where aspiration line extends through hand piece to eye);
vibrating the phacoemulsification needle to emulsify a lens of the eye (see [0005]);
receiving irrigation fluid from an irrigation line (1140) into an irrigation channel (see [0024]: channel where irrigation line extends through hand piece) and flowing the irrigation fluid into a lens capsule of the eye (see [0006]);
removing material from the lens capsule (see [0008], [0010]) into an aspiration channel (see [0024]: where aspiration line extends through hand piece to eye) and evacuating the removed material to an aspiration line (1155, see [0024]);
detecting an early indication of a drop in an intraocular pressure (IOP) below a prespecified limit based on at least one pressure measurement, of the drop in IOP below the prespecified limit (see [0042]: detecting pressure below acceptable thresholds);
in response to detecting the early indication (see [0030-0032]: sensors polled every 10 milliseconds, aligning with “early” definition by applicant in [0055]: “early” indication is feedback within several mSec) of the drop in the IOP below the prespecified limit (see [0010] and [0042]), calculating (see [0076-0086]: prespecified limits for IOP set and controller makes adjustments to maintain flow rate), a required change in a rate (see [0046-0067]: calculations used to modify irrigation flow rate) of an irrigation pump (see [0026]: irrigation fluid can be pressurized by a pump) that is coupled with the irrigation line (1140, see [0031], [0076-0092]) and a required change (see [0070], [0092-0093], and [0106-0107]: aspiration fluid flow can also be calculated and modified to achieve desired IOP) in a rate of an aspiration pump (1170, see [0044]) that is coupled with the aspiration line (1155, see [0032]), wherein the required change in the rate of the irrigation pump and the required change in the rate of the aspiration pump are calculated to cause a subsequent measurement of the IOP to fall within a prespecified range (see [0076-0093]: aspiration and irrigation flow rates for maintaining desired IOP);
adjusting an operation of the irrigation pump in accordance with the required change in the rate of the irrigation pump (see at least [0076-0093]); and
adjusting an operation of the aspiration pump in accordance with the required change in the rate of the aspiration pump (see at least [0076-0093]),
wherein the required change in the rate of the irrigation pump and the required change in the rate of the aspiration pump are calculated to cause the IOP to remain above the prespecified limit (see at least [0076-0093]).
Boukhny is silent to the phacoemulsification probe comprising “a piezoelectric crystal”, “measuring an electrical impedance of the piezoelectric crystal;”, detecting “based on the measured electrical impedance of the piezoelectric crystal…prior to…” detection of the drop in IOP, based on at least one pressure measurement, and calculating “based on the measured electrical impedance”, and causing the “electrical impedance” to fall within prespecified limits.
However, Kad teaches a method comprising inserting (see [0005]: phacoemulsification devices are used to emulsify the eye lens and see [0053]: handpiece is applied to the eye and handpiece includes electrical means/ crystal for vibrating the needle) into an eye (38, see FIG. 2) a phacoemulsification probe (30), the phacoemulsification probe (30) comprising a piezoelectric crystal (within 30, see [0053]: block 30 contains handpiece and electrical means, typically a piezoelectric crystal and [0054]: FIG. 2 incorporates all relevant components of FIG. 1.). Kad teaches the method further comprising measuring an electrical impedance of the piezoelectric crystal (see [0060]: monitoring handpiece electrical signals to adjust frequency and see [0059]: frequency is of impedance and [0035]: impedance is of the piezoelectric crystal as shown in FIG.8), detecting a pressure based on the measured electrical impedance of the piezoelectric crystal (see FIG. 10 and [0072-0074]), calculating a required change based on the measured electrical impedance (see [0057-0067]: measuring impedance and performing calculation such as converting phase to voltage and filtering), and causing the electrical impedance to fall within prespecified limits (see [0075-0080]: pump rates are modified to ensure that the impedance –related to frequency and phase angle as in [0057-0067]—fall within the defined limits).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the phacoemulsification probe used in the method disclosed by Boukhny to be a phacoemulsification probe comprising a piezoelectric crystal as taught by Kad for the purpose of using a probe that is readily provided in phacoemulsification systems (see [0007]), thus achieving the phacoemulsification probe comprising “a piezoelectric crystal”.
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method using the phacoemulsification probe taught by Boukhny in view of Kad to include measuring electrical impedance, detecting a pressure based on electrical impedance, and calculating based on the electrical impedance to cause the electrical impedance to fall within specified limits as taught by Kad for the purpose of modulating the power provided to the piezoelectric crystal to ensure efficacy of treatment (see [0007-0014]), thus achieving the method comprising “measuring an electrical impedance of the piezoelectric crystal;”, detecting “based on the measured electrical impedance of the piezoelectric crystal…prior to…” detection of the drop in IOP, based on at least one pressure measurement (Boukhny in view of Kad now includes both the pressure and impedance measurements monitored by the processor and therefore meet this limitation as interpreted under 112b above), and calculating “based on the measured electrical impedance”, and causing the “electrical impedance” to fall within prespecified limits.
Regarding claim 6, the modified method of Boukhny teaches the method according to claim 5, and Boukhny further discloses wherein controlling the operation of the irrigation pump and controlling the operation of the aspiration pump comprise adaptively operating the irrigation pump and the aspiration pump simultaneously (see [0046-0047] & [0050]: operating irrigation flow and pump and [0052-0061]: both irrigation and aspiration pumps controlled to achieve desired flow rate).
Regarding claim 11, the modified system of Boukhny teaches the method according to claim 5, and Boukhny further discloses detecting an early indication of a drop in an intraocular pressure (IOP) below a prespecified limit (see [0042]: detecting pressure below acceptable thresholds), wherein the early indication of the drop in IOP further indicates a post-occlusion surge (see [0010-0011] and [0046-0047]) risk (see [0014]: pressure can indicate occlusion being present/ before occlusion breaking, thus indicating a surge “risk”. See also [0048], [0050], [0076], [0078], [0086])
Claims 7-8 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Boukhny in view of Kad as applied to claim 5 above, and further in view of Sorensen (U.S. PGPUB No. 2014/0323953).
Regarding claim 7, the modified method of Boukhny teaches the method according to claim 5, but Modified Boukhny is silent to “further comprising controlling at least one of an irrigation flow rate or an aspiration flow rate by operating a valve coupled with at least one of the irrigation line and the aspiration line.”
However, Sorensen teaches a method comprising inserting into an eye (see [0005]) a phacoemulsification probe (112, see FIG. 3), the method further comprising controlling at least one of an irrigation flow rate or an aspiration flow rate (see [0029]: pressure supplied by pump and see [0035-0038]: valve control to achieve desired pressure. Therefore the valve controls the pumping rate to achieve desired pressure) by operating a valve (350) coupled with (see [0029]) at least one of an irrigation line and an aspiration line (305).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method taught by Modified Boukhny to include operating a valve coupled with the aspiration line to control the aspiration rate as taught by Sorensen for the purpose of decreasing the effects of an occlusion surge (see [0029]), thus achieving “further comprising controlling at least one of an irrigation flow rate or an aspiration flow rate by operating a valve coupled with at least one of the irrigation line and the aspiration line.”
Regarding claim 8, the modified method of Boukhny teaches the method according to claim 5, but Modified Boukhny is silent to “further comprising controlling at least one of an irrigation flow rate or an aspiration flow rate by operating a valve coupled with at least one of the irrigation channel or the aspiration channel.”
However, Sorensen teaches a method comprising inserting into an eye (see [0005]) a phacoemulsification probe (112, see FIG. 3), the method further comprising controlling at least one of an irrigation flow rate or an aspiration flow rate (see [0029]: pressure supplied by pump and see [0035-0038]: valve control to achieve desired pressure. Therefore the valve controls the pumping rate to achieve desired pressure) by operating a valve (350) coupled with (see [0029]) at least one of an irrigation channel and an aspiration channel (325).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method taught by Modified Boukhny to include operating a valve coupled with the aspiration channel to control the aspiration rate as taught by Sorensen for the purpose of decreasing the effects of an occlusion surge (see [0029]), thus achieving “further comprising controlling at least one of an irrigation flow rate or an aspiration flow rate by operating a valve coupled with at least one of the irrigation channel or the aspiration channel.”
Regarding claim 12, the modified method of Boukhny teaches the method according to claim 5, but Modified Boukhny is silent to “further comprising controlling at least one of a first valve coupled with the irrigation line or a second valve coupled with the aspiration line in response to detecting the early indication of the drop in the IOP below the prespecified limit.”
However, Sorensen teaches a method comprising inserting into an eye (see [0005]) a phacoemulsification probe (112, see FIG. 3), the method further comprising controlling (See [0031-0038] and FIG.4 for processor control of valve 350) at least one of a first valve coupled with the irrigation line or a second valve (350) coupled with the aspiration line (305) in response to detecting an early indication (see [0033]: pressure detection & response occur within 50milliseconds, aligning with Applicant disclosure in [0055]: “early” indication is feedback within several mSec) of a drop in an IOP below a prespecified limit (see [0032-0033]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method taught by Modified Boukhny to include controlling a valve in response to the detecting the early indication of the drop in IOP below the prespecified limit as taught by Sorensen for the purpose of providing real time surge suppression (see [0033]), thus achieving “further comprising controlling at least one of a first valve coupled with the irrigation line or a second valve coupled with the aspiration line in response to detecting the early indication of the drop in the IOP below the prespecified limit.”
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Shelton in view of Sorensen as applied to claim 1 above, and further in view of Wilson et al. (U.S. PGPUB No. 2014/0163455), hereinafter Wilson.
Regarding claim 9, the modified system of Shelton teaches the phacoemulsification system according to claim 1, but Shelton is silent to “wherein the early indication of the drop in IOP further indicates a post-occlusion surge risk.”
However, Sorensen teaches a phacoemulsification system (see FIG. 1 and [0024]), comprising: a phacoemulsification probe (112, see FIG. 3 for all other reference numerals unless otherwise noted), comprising: a processor (360), which is configured to receive the measured pressure (see [0033]); the processor (360) configured to detect, based on the measured pressure an early indication (see [0033]: pressure detection & response occur within 50milliseconds, aligning with Applicant disclosure in [0055]: “early” indication is feedback within several mSec) of a drop in an intraocular pressure (IOP) below a prespecified limit (see [0032]: one or more pressure thresholds can be established, such as a minimum operating pressure and [0033]: pressure used to inform drop in IOP); wherein the early indication of the drop in IOP further indicates an occlusion surge (see [0031]:controller used to mitigate pressure deviations, such as occlusion surge & [0033]: pressure detection within 50mseconds of occlusion break).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the processor configured to detect, measure, and maintain the system pressure, via impedance, within prespecified limits by modifying system pumping rates disclosed in Shelton to specifically maintain an intraocular pressure as taught by Sorensen for the purpose of adapting the surgical system for use in a phacoemulsification procedure that has varying flow rates resulting in varying pressure losses and occlusions that must be monitored and maintained for procedure efficacy (see [0007-0009] and [0024]), thus achieving “wherein the early indication of the drop in IOP further indicates” an occlusion surge.
Shelton in view of Sorensen remain silent to wherein the early indication of the drop in IOP further indicates a “post-occlusion surge risk”.
However, Wilson teaches a phacoemulsification hand piece (see FIG. 1 and [0004-0006]) with a controller (405, see FIG. 3) for maintaining an intraocular pressure between threshold values (see [0030-0033] and [0042-0043]), wherein an early indication of a drop in IOP indicates a post-occlusion surge risk (see [0008-0009]: drop in pressure indicates post-occlusion surge & [0039]: “Detecting pressure conditions close to the surgical site results in early detection of occlusion breaks, and therefore, allowing for early response to prevention of occlusion surges.”, which therefore teaches early indication of post-occlusion surge risk based on the pressure readings. See also [0041]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the processor monitoring the early indication of the drop in IOP taught by Modified Shelton to specifically use the sensed values of the drop in IOP to be an early indication of a post-occlusion surge risk as taught by Wilson for the purpose of forming a more consistent and predictable phacoemulsification procedure by reducing the effects of pressure deviations that occur with post-occlusion surges (see [0041]), thus achieving wherein the early indication of the drop in IOP further indicates a “post-occlusion surge risk”.
Response to Arguments
Applicant's arguments filed 02/03/26 have been fully considered but they are not persuasive.
Applicant argues that the prior art fails to teach the limitation that the impedance-based detection occurs “prior to” the detection by the pressure sensor (see pages 7-9 of Applicant Remarks). However, in view of Applicant disclosure and the 112a&112b rejections above, the examiner maintains that the prior art of record meets the limitation as claimed in as much as is disclosed by Applicant.
Therefore, the examiner has maintained the 35 U.S.C. § 103 claim rejections as previously set forth in the non-final rejection mailed 11/06/25.
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.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Papac (U.S. PGPUB No. 2017/0304018) teaches a phacoemulsification system (see [0001]) with a controller (110, see Fig. 1A) for maintaining a desired intraocular pressure (see [0052]), wherein the controller PREDICTS intraocular pressure in the eye based on sensor readings such as pressure or calculated impedance (see [0052-0053])
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHLEEN PAIGE VOKES whose telephone number is (571)272-0198. The examiner can normally be reached M-F: 730AM-330PM Eastern Time.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KATHLEEN PAIGE VOKES/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
Prosecution Insights