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 .
DETAILED ACTION
Status of Claims
This office action is in response to the amendment and remarks filed on 03/30/2026. In making the below rejections, the examiner has considered and addressed each of the applicants arguments. Claims 6 and 14 have been canceled, Claims 3, 4, 9-13, 15-31 are withdrawn, and Claims 1, 2, 5, 7, and 8 are currently pending and being examined.
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 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.
Election By Original Presentation
Claims 9, 10, 13, 15 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: the claims are not directed to the selected species, Species 1 and Sub-Species 1, figs 4 and 6, show a chamber in the cassette body not in the handpiece. Applicant’s arguments indicate that there is a chamber in the handpiece in claim 9 and its dependents. Species 1 does not show a chamber in the handpiece.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 9, 10, 13, 15 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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, and 2 are rejected under 35 U.S.C. 103 as being unpatentable over Ovchinnikov (USPAP 2018/0207330) in view of Eichler (USPAP 2011/0054385).
In reference to independent claim 1, Ovchinnikov discloses a surgical cassette (“cassette body”, fig 3) for an ophthalmic surgical system (all of fig 3), comprising: an irrigation system (system connected to 315, fig 3) in fluid communication with a handpiece (112) and configured to carry fluid toward a surgical site (322); and an aspiration system (system connected to 325) in fluid communication with the handpiece (112) via an aspiration conduit (325), the aspiration system configured to carry fluid away from the surgical site (area of the eye), the aspiration system comprising a chamber (340) configured to: expand to store fluid (340, para 0025 discloses “the vent reservoir 340 may be a drain bag” examiner takes the position that a bag will expand as a function of how much fluid is in it) and
A controller (360) configured to instruct the chamber (340) to actively expand (para 0025 discloses “the vent reservoir 340 may be a drain bag” examiner takes the position that a bag will expand as a function of how much fluid is in it) to meet the volume demand based on an irrigation pressure detected by an irrigation pressure sensor (365) located in the handpiece (365, fig 4; para 0029 discloses “the hand piece 112 also includes a pressure sensor 365 and an acoustic streaming arrangement 368. The pressure sensor 365 is disposed in the hand piece 112 along the irrigation conduit 315.”
para 0033 goes onto disclose “The controller 360 is operable to communicate with the pressure sensor 365 located within the hand piece 112, the aspiration pressure sensor 330, the vent valve 350, and the driving device 372, and may be further operable to communicate with one or more other pressure sensors, fluid flow sensors, and/or control devices, such as valves or pressure regulation devices.” Controller 360 uses the vent valve to control the pressure).
Ovchinnikov is silent to the chamber controlled to actively expand and collapse to meet the volume demand to move the fluid to meet a volume demand in the aspiration conduit to mitigate a post-occlusion break surge.
Eichler, a similar ophthalmic system, teaches a chamber controlled (para 0016 discloses “The third irrigation fluid source can be a third piston pump, which is provided with a controllable drive, wherein the third piston pump is suitable for dispensing irrigation fluid contained in the piston into the aspiration line. A large fluid volume at high pressure can quickly be provided by appropriate actuation of the third piston pump.”) to actively expand and collapse to meet the volume demand to store fluid (para 0017 discloses “the third irrigation fluid source [60] is connected to the first irrigation fluid source via a filling line, in which a sixth valve is arranged. Hence, pressure balance in the aspiration line can be realized with an appropriately connected sixth valve such that there is complete separation from the first irrigation fluid source. Therefore, no pressure variations are excited in the first irrigation fluid line when an occlusion is pierced or when the aspiration fluid line is ventilated”
examiner takes the position that piston 61 is controlled to control for pressure variation in both directions, this is further evidenced by the valve 67 oriented in such a way that fluid flows into the chamber 60, which would move the piston down, finally in order to complete the explicitly disclosed action the piston MUST move down at least once to aspirate material); and
collapsing to move the fluid to meet a volume demand in the aspiration conduit to mitigate a post-occlusion break surge (para 0030 discloses “Negative pressure can form in the aspiration fluid line 11 if there is an occlusion or obstruction of the line 11 during aspiration. When the obstruction breaks open, this results in dangerous suction that can suction out too much fluid from the interior space of the eye. In order to prevent this (see FIG. 5), provision can be made for a third irrigation fluid source 60 with a piston 61, a piston rod 62 and a drive 66, which supplies irrigation fluid 63 via a fifth valve 67 to the aspiration fluid line 11 via a third irrigation fluid line 68 as a function of negative pressure in the aspiration fluid line 11. This can reliably prevent a collapse of the interior space of the eye.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the chamber and chamber control method of Eichler in the system of Ovchinnikov so “A large fluid volume at high pressure can quickly be provided by appropriate actuation of the third piston pump” , (para 0016 Eichler) to keep pressure constant thereby suppressing surge as disclosed in Eichler. To be clear the modification is done by adding piston and chamber of Eichler in the position of the vent reservoir.
In reference to dependent claim 2, Ovchinnikov in view of Eichler discloses the surgical cassette of Claim 1, Eichler further discloses the chamber comprising a piston (61, fig 5) configured to: move in a first direction to expand the chamber to store the fluid (described in further detail above, done at least upon initial “charging” with fluid and based on the “no pressure variations” in para 0017 the piston is controlled in both directions to mitigate pressure variations); and move in a second direction to collapse the chamber to move the fluid to meet the volume demand (para 0030 discloses “provision can be made for a third irrigation fluid source 60 with a piston 61, a piston rod 62 and a drive 66, which supplies irrigation fluid 63 via a fifth valve 67 to the aspiration fluid line 11 via a third irrigation fluid line 68 as a function of negative pressure in the aspiration fluid line 11. This can reliably prevent a collapse of the interior space of the eye.”).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Ovchinnikov (USPAP 2018/0207330) in view of Eichler (USPAP 2011/0054385) with evidentiary support from Caffey (WO 2011/133724).
In reference to dependent claim 7, Ovchinnikov in view of Eichler discloses the surgical cassette of Claim 1, Eichler further discloses the chamber (60, fig 5) comprising a pressure-sensitive actuator (the piston) that is configured to passively collapse the chamber in response to a change in pressure to move the fluid to meet the volume demand in the aspiration conduit (examiner takes the position that this can be accomplished by simply letting the motor free spin so the piston moves as a function of pressure only, furthermore Caffey, a similar pump used in ophthalmic procedures, teaches “smaller implantable pumps for drug delivery to the eye or the middle ear, or refillable drug pumps (where a diaphragm or piston collapses back to its initial state” which provides further support that the chamber 60 can passively collapse due to a pressure fluctuation in the output line).
Claims 5 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Ovchinnikov (USPAP 2018/0207330) in view of Eichler (USPAP 2011/0054385) further in view of Zacharias (USPN 8,617,106).
In reference to dependent claim 5, Ovchinnikov in view of Eichler discloses the surgical cassette of Claim 1, Ovchinnikov discloses a cassette further comprising a valve (350, fig 3) configured to: expand the chamber to store the fluid (when there is positive pressure opening the valve allows fluid to flow into 340); and collapse the chamber to move the fluid to meet the volume demand (when there is negative pressure opening the valve allows fluid to flow out of 340), however
Ovchinnikov is silent to a solenoid valve.
Zacharias, a similar ophthalmic system, teaches a solenoid valve (col 12, lines 3-4 discloses “valve 270 has an input 280 and an output 282. An actuator portion 274 with solenoid 284”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the reverse pump operation as taught in Zacharias in the system of Ovchinnikov in view of Eichler to help “virtually eliminates the instability of the anterior chamber that results from post-occlusion surges” col 4, lines 62-63; Zacharias.
In reference to dependent claim 8, Ovchinnikov in view of Eichler discloses the surgical cassette of Claim 1, Ovchinnikov further discloses a cassette wherein the aspiration system comprising an aspiration pump (335), however
Ovchinnikov is silent to the pump configured to be reversed to supply fluid to meet the volume demand in the aspiration conduit.
Zacharias, a similar ophthalmic system, teaches a pump configured to be reversed to supply fluid to meet the volume demand in the aspiration conduit (col 19, lines 66-4 discloses “pump configured to be reversed to supply fluid to meet the volume demand in the aspiration conduit”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the reverse pump operation as taught in Zacharias in the system of Ovchinnikov in view of Eichler to help “virtually eliminates the instability of the anterior chamber that results from post-occlusion surges” col 4, lines 62-63; Zacharias.
Response to Arguments
In response to applicant’s argument that “Ovchinnikov Fails to Disclose a Chamber Located in a Handpiece as Recited By Claim 9” examiner agrees. However examiner interpreted the chamber to be in the cassette body since the species the applicant chose shows a chamber in the cassette body rather than in the handpiece. Therefore examiner has withdrawn claim 9 and its dependent since it reads on an unselected embodiment. Examiner thanks applicant for clarifying their claim language.
In response to applicant’s argument that “neither Ovchinnikov nor Eichler, taken either singly or in combination, teaches or suggests a controller that is configured to instruct a chamber to actively expand and collapse to meet a volume demand based on an irrigation pressure detected by an irrigation pressure sensor, as recited by Claims 1 and 9. While Eichler discloses that the third piston pump is suitable for dispensing irrigation fluid contained in the piston into the aspiration line, Eichler fails to teach or suggest that his third piston pump may receive instructions to "actively expand and collapse" to meet a volume based on an irrigation pressure detected by an irrigation pressure sensor”
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.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHARLES W NICHOLS whose telephone number is (571)272-6492. The examiner can normally be reached Monday-Friday 8am-5pm EST.
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.
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/C.W.N/Examiner, Art Unit 3783 /WESLEY G HARRIS/Examiner, Art Unit 3783
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