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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/21/26 has been entered.
Response to Amendment
The Amendment filed 01/21/26 has been entered. Claims 1, 6, and 11 have been amended, new claims 29-30 have been entered, and claims 14-28 remain withdrawn. Claims 1, 3-6, 8-13, and 29-30 are addressed in the following office action.
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.
Claims 1, 3-5, and 8-13 are rejected under 35 U.S.C. 103 as being unpatentable over Mehta et al. (US 2019/0099547) in view of Dlugos et al. (US 2008/0015406), both cited in previous office action.
Regarding claims 1, 3-4, and 8-9, an invention relating to an intra-ocular instruments, Mehta discloses (Figs. 2 & 7) a phacoemulsification system (100), comprising: a phacoemulsification probe (24), comprising: a needle, which is configured to be inserted into a lens capsule of an eye and to be vibrated to emulsify a lens of the eye (Par. 0047 & 0059); an irrigation channel (32), configured for flowing irrigation fluid into the lens capsule (Par. 0047); and an aspiration channel (42), configured for removing at least eye fluid from the lens capsule (Par. 0046-0047); and a connector assembly (52/720), which is coupled with a proximal end of the phacoemulsification probe (Par. 0038, 0051, 0123), wherein the connector assembly further comprises at least one of: a first pressure sensing assembly (PSA) (56) configured to sense the pressure of the eye fluid flowing in between (Par. 0038, 0051, 0123), or a second PSA (54) configured to sense the pressure of the irrigation fluid flowing in between (Par. 0038, 0051, 0123), and wherein the connector assembly further comprises an electrical connector (720) configured to disable operation of the phacoemulsification probe when the connector assembly is disconnected from the phacoemulsification probe [i.e. detachment of element 720 would disconnect power and would disable transmission of sensor measurement data (Par. 0038, 0081, 0131)
However, Mehta fails to disclose wherein the connector assembly comprises a housing including at least one of: an aspiration passage fluidly coupling an aspiration tube to the aspiration channel and configured to pass at least the eye fluid away from the aspiration channel to the aspiration tube, or an irrigation passage fluidly coupling an irrigation tube to the irrigation channel and configured to pass the irrigation fluid into the irrigation channel, wherein the connector assembly further comprises at least one of: the first pressure sensing assembly (PSA) disposed in the aspiration passage, or the second PSA disposed in the irrigation passage [Claim 1]; wherein the first PSA comprises: (i) a first hollow tube, which is inserted between the aspiration channel and the aspiration tube, and is configured to permit flow of at least the eye fluid, and (ii) a first pressure sensing device (PSD) , which is placed in direct contact with the eye fluid flowing in the hollow tube and is configured to produce a first pressure signal indicative of the pressure of the eye fluid flowing between the aspiration channel and the aspiration tube [Claim 3]; and further wherein the first hollow tube comprises, a first luer connector coupled with the aspiration channel, and a second luer connector coupled with the aspiration tube, and wherein the first PSD is positioned between the first luer connector and the second luer connector [Claim 4]; wherein the second PSA comprises: (i) a second hollow tube, which is inserted between the irrigation channel and the irrigation tube, and is configured to permit flow of at least the irrigation fluid, and (ii) a second PSD, which is placed in direct contact with the irrigation fluid flowing in the second hollow tube and is configured to produce a second pressure signal indicative of the pressure of the irrigation fluid flowing between the irrigation tube and the irrigation channel [Claim 8]; and further wherein the second hollow tube comprises a first luer connector coupled with the irrigation channel and a second luer connector coupled with the irrigation tube, and wherein the second PSD is positioned between the first luer connector and the second luer connector [Claim 9].
In the analogous art of sensors, Dlugos teaches (Figs. 6-7) wherein connector assembly (410) comprises a housing (Par. 0037) including: a passage [i.e. fluid conduit] (Par. 0039) fluidly coupling a tube (404) to a channel (424 & 430) and configured to pass at least the eye fluid away from the channel to the tube (Par. 0035 & 0059), wherein the connector assembly further comprises a pressure sensing assembly (PSA) disposed in the passage [i.e. the portion of element 426 that makes up part of the passage (see annotated figure below)] and configured to sense the pressure of the eye fluid flowing between the channel and the tube (Par. 0036-0041); further wherein the PSA comprises: i) a hollow tube (416 & 418), which is inserted between the channel and the tube, and is configured to permit flow of at least the eye fluid, and (ii) a pressure sensing device (PSD) (426) , which is placed in direct contact with the eye fluid flowing in the hollow tube and is configured to produce a pressure signal indicative of the pressure of the eye fluid flowing between the channel and the tube (Par. 0039); and further wherein the hollow tube comprises, a first luer connector (412) coupled with the channel, and a second luer connector (416) coupled with the tube, and wherein the PSD is positioned between the first luer connector and the second luer connector (Par. 0037-0039).
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Mehta to have wherein the connector assembly comprises a housing including at least one of: an aspiration passage fluidly coupling an aspiration tube to the aspiration channel and configured to pass at least the eye fluid away from the aspiration channel to the aspiration tube, or an irrigation passage fluidly coupling an irrigation tube to the irrigation channel and configured to pass the irrigation fluid into the irrigation channel, wherein the connector assembly further comprises at least one of: the first pressure sensing assembly (PSA) disposed in the aspiration passage, or the second PSA disposed in the irrigation passage [Claim 1]; wherein the first PSA comprises: (i) a first hollow tube, which is inserted between the aspiration channel and the aspiration tube, and is configured to permit flow of at least the eye fluid, and (ii) a first pressure sensing device (PSD) , which is placed in direct contact with the eye fluid flowing in the hollow tube and is configured to produce a first pressure signal indicative of the pressure of the eye fluid flowing between the aspiration channel and the aspiration tube [Claim 3]; and further wherein the first hollow tube comprises, a first luer connector coupled with the aspiration channel, and a second luer connector coupled with the aspiration tube, and wherein the first PSD is positioned between the first luer connector and the second luer connector [Claim 4]; wherein the second PSA comprises: (i) a second hollow tube, which is inserted between the irrigation channel and the irrigation tube, and is configured to permit flow of at least the irrigation fluid, and (ii) a second PSD, which is placed in direct contact with the irrigation fluid flowing in the second hollow tube and is configured to produce a second pressure signal indicative of the pressure of the irrigation fluid flowing between the irrigation tube and the irrigation channel [Claim 8]; and further wherein the second hollow tube comprises a first luer connector coupled with the irrigation channel and a second luer connector coupled with the irrigation tube, and wherein the second PSD is positioned between the first luer connector and the second luer connector [Claim 9], as taught by Dlugos. Doing so would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided Mehta with an in-line sensor system as taught by Dlugos. Mehta discloses other locations for the sensors 54 and 56 are envisioned anywhere in the system 100 and may be in communication with one or more irrigation and/or aspiration lines via different mechanism, e.g. resident in line with one or more irrigation and/or aspiration lines (Par. 0051), thus Dlugos in-line sensor system would have provided Mehta with a sufficient means for sensing eye fluid.
Regarding claim 5, Mehta, as modified by Dlugos, discloses the phacoemulsification system according to claim 3. Mehta discloses further comprising a wire (see annotated figure below), which is connected to the first PSD [i.e. sensor] and is configured to transmit the first pressure signal to a processor of a phacoemulsification console (Par. 0051-0052 & 0075).
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Regarding claim 10, Mehta, as modified by Dlugos, discloses the phacoemulsification system according to claim 8. Mehta discloses further comprising a second wire (see annotated figure below), which is connected to the second PSD [i.e. sensor] and is configured to transmit the second pressure signal to a processor of a phacoemulsification console (Par. 0051-0052 & 0075). Note, Dlugos explicitly teaches a wire (422), which is connected to the PSD and is configured to transmit the pressure signal to a processor of a phacoemulsification console (Par. 0035-0036 & 0053).
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Regarding claims 11-13, Mehta, as modified by Dlugos, discloses the phacoemulsification system according to claim 1. Mehta further discloses (Fig. 2) wherein the connector assembly is a first sensing assembly that comprises the first PSA (56) coupled in line to the aspiration channel and configured to sense the pressure of the eye fluid flowing in between; wherein the phacoemulsification system further comprises a second sensing assembly, wherein the second assembly comprises the second pressure sensing assembly (54) coupled in line to the irrigation channel and configured to sense the pressure of the irrigation fluid flowing in between (Par. 0038, 0051, 0123).
However, Mehta fails to disclose the first PSA coupled between the aspiration tube and the aspiration channel and configured to sense the pressure of the eye fluid flowing between the aspiration channel and the aspiration tube; and further comprises the second pressure sensing assembly coupled between the irrigation tube and the irrigation channel and configured to sense the pressure of the irrigation fluid flowing between the irrigation tube and the irrigation channel [Claim 11]; further wherein the first PSA comprises: i) a first hollow tube, which is inserted between the aspiration channel and the aspiration tube and is configured to permit flow of at least the eye fluid, and (ii) a first pressure sensing device (PSD) , which is placed in direct contact with the eye fluid flowing in the first hollow tube and is configured to produce a first pressure signal indicative of the pressure of the eye fluid flowing between the aspiration channel and the aspiration tube; and wherein the second PSA comprises: (i) a second hollow tube, which is inserted between the irrigation channel and the irrigation tube and is configured to permit flow of at least the irrigation fluid, and (ii) a second pressure sensing device (PSD) , which is placed in direct contact with the irrigation fluid flowing in the second hollow tube and is configured to produce a pressure signal indicative of the pressure of the irrigation fluid flowing between the irrigation tube and the irrigation channel [Claim 12]; and further wherein the first hollow tube comprises a first luer connector coupled with the aspiration channel, and a second luer connector coupled with the aspiration tube, and wherein the first PSD is positioned between the first luer connector and the second luer connector; and wherein the second hollow tube comprises, a third luer connector coupled with the irrigation channel, and a fourth luer connector coupled with the irrigation tube, and wherein the second PSD is positioned between the third luer connector and the fourth luer connector [Claim 13].
In the analogous art of sensors, Dlugos teaches (Figs. 6-7) an in-line sensing system comprising a PSA coupled between a tube (404) and a channel (424 & 430) and configured to sense the pressure of the eye fluid flowing between the channel and the tube (Par. 0036-0041); further wherein the PSA comprises: i) a hollow tube (416 & 418), which is inserted between the channel and the tube, and is configured to permit flow of at least the eye fluid, and (ii) a pressure sensing device (PSD) (426) , which is placed in direct contact with the eye fluid flowing in the hollow tube and is configured to produce a pressure signal indicative of the pressure of the eye fluid flowing between the channel and the tube (Par. 0039); and further wherein the hollow tube comprises, a first luer connector (412) coupled with the channel, and a second luer connector (416) coupled with the tube, and wherein the PSD is positioned between the first luer connector and the second luer connector (Par. 0037-0039).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Mehta in view of Dlugos, to have the first PSA coupled between the aspiration tube and the aspiration channel and configured to sense the pressure of the eye fluid flowing between the aspiration channel and the aspiration tube; and further comprises the second pressure sensing assembly coupled between the irrigation tube and the irrigation channel and configured to sense the pressure of the irrigation fluid flowing between the irrigation tube and the irrigation channel [Claim 11]; further wherein the first PSA comprises: i) a first hollow tube, which is inserted between the aspiration channel and the aspiration tube and is configured to permit flow of at least the eye fluid, and (ii) a first pressure sensing device (PSD) , which is placed in direct contact with the eye fluid flowing in the first hollow tube and is configured to produce a first pressure signal indicative of the pressure of the eye fluid flowing between the aspiration channel and the aspiration tube; and wherein the second PSA comprises: (i) a second hollow tube, which is inserted between the irrigation channel and the irrigation tube and is configured to permit flow of at least the irrigation fluid, and (ii) a second pressure sensing device (PSD) , which is placed in direct contact with the irrigation fluid flowing in the second hollow tube and is configured to produce a pressure signal indicative of the pressure of the irrigation fluid flowing between the irrigation tube and the irrigation channel [Claim 12]; and further wherein the first hollow tube comprises a first luer connector coupled with the aspiration channel, and a second luer connector coupled with the aspiration tube, and wherein the first PSD is positioned between the first luer connector and the second luer connector; and wherein the second hollow tube comprises, a third luer connector coupled with the irrigation channel, and a fourth luer connector coupled with the irrigation tube, and wherein the second PSD is positioned between the third luer connector and the fourth luer connector [Claim 13], as taught by Dlugos. Doing so would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided Mehta with an in-line sensor system as taught by Dlugos. Mehta discloses other locations for the sensors 54 and 56 are envisioned anywhere in the system 100 and may be in communication with one or more irrigation and/or aspiration lines via different mechanism, e.g. resident in line with one or more irrigation and/or aspiration lines (Par. 0051), thus Dlugos in-line sensor system would have provided Mehta with a sufficient means for sensing irrigation fluid and eye fluid.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Mehta et al. (US 2019/0099547), in view of Dlugos et al. (US 2008/0015406), as applied to claim 1 above, and further in view of Kadziauskas et al. (US 6,083,193), cited in previous office action.
Regarding claim 6, Mehta discloses the phacoemulsification system according to claim 1. However, Mehta fails to discloses wherein the connector assembly comprises a temperature sensor coupled with the aspiration channel and configured to sense a temperature of the eye fluid at the proximal end of the phacoemulsification probe.
In the same field of endeavor, which is phacoemulsification systems, Kadziauskas teaches (Fig. 1) wherein the connector assembly comprises a temperature sensor (50, 52) coupled with the aspiration channel (40) and configured to sense a temperature of the eye fluid at the proximal end of the phacoemulsification probe (Col. 3, lines 34-43).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Mehta, in view of Dlugos, to have wherein the connector assembly comprises a temperature sensor coupled with the aspiration channel and configured to sense a temperature of the eye fluid at the proximal end of the phacoemulsification probe. Doing so would prevent thermal damage to eye tissue (Abstract & Col. 2, lines 44-52), as taught by Kadziauskas.
Claims 29-30 are rejected under 35 U.S.C. 103 as being unpatentable over Mehta et al. (US 2019/0099547), in view of Dlugos et al. (US 2008/0015406), as applied to claim 1 above, and further in view of Källbäck et al. (US 2016/0228061).
Regarding claim 29, Mehta, as modified by Dlugos, discloses the phacoemulsification system according to claim 1. Mehta fails to disclose wherein at least one of the first PSA or the second PSA is incorporated into a flexible printed circuit board (PCB) that is wrapped around and coupled with a hollow tube.
In the analogous art of sensors, Källbäck teaches wherein at least one of the first PSA or the second PSA is incorporated into a flexible printed circuit board (PCB) that is wrapped around and coupled with a hollow tube (Par. 0044 & 0055).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Mehta, in view of Dlugos, to have wherein at least one of the first PSA or the second PSA is incorporated into a flexible printed circuit board (PCB) that is wrapped around and coupled with a hollow tube. Doing so would allow the device to take on various curvilinear shapes, bends, and motions during use (Par. 0044), as taught by Källbäck.
Regarding claim 30, Mehta, in view of Dlugos and Källbäck, discloses wherein the hollow tube comprises an opening, and wherein the at least one of the first PSA or the second PSA is bonded over the opening such that the at least one of the first PSA or the second PSA is exposed to fluid flowing through the hollow tube to measure the fluid pressure and fluid is prevented from leaking through the opening [i.e. opening in element 428, see Dlugos figure 7 and paragraph 0038].
Response to Arguments
Applicant's arguments filed 01/21/26 have been fully considered but they are not persuasive.
Applicant argues that the previously cited prior art references fail to disclose “wherein the connector assembly further comprises an electrical connector configured to disable operation of the phacoemulsification probe when the connector assembly is disconnected from the phacoemulsification probe”, as detailed in amended claim 1. Examiner respectfully disagrees.
Previously cited prior art reference Mehta discloses (Fig. 3) wherein the connector assembly further comprises an electrical connector (720) configured to disable operation of the phacoemulsification probe when the connector assembly is disconnected from the phacoemulsification probe [i.e. detachment of element 720 would disconnect power and would disable transmission of sensor measurement data, hence a disabled operation] (Par. 0038, 0081, 0131).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Examiner Chima Igboko whose telephone number is (571)272-8422. The examiner can normally be reached on Monday-Friday 9:00am-6:00pm.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Jackie Ho, at (571) 272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/C.U.I/ Examiner, Art Unit 3771
/ASHLEY L FISHBACK/Primary Examiner, Art Unit 3771 March 10, 2026