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
A preliminary amendment was filed on 10/25/2025. Claims 1-19 have been canceled, and new claims 20-39 have been added. Currently, claims 20-39 are pending and are being examined on the merits.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 20-35 and 39 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Sorensen (US 20140323953).
Regarding claim 20, Sorensen discloses an ophthalmic surgical system, comprising:
an irrigation conduit (315) in fluid communication with a handpiece and configured to carry fluid toward a surgical site (fig. 3, irrigation line 315 to take fluid from irrigation bag 310 to an eye);
an aspiration conduit (325) in fluid communication with the handpiece and configured to carry fluid away from the surgical site (fig. 3, aspiration line 325);
a reservoir configured to hold fluid (fig. 3, vent reservoir 340);
a valve in fluid communication with the aspiration conduit and the reservoir (fig. 3, vacuum relief valve 350 in communication with aspiration line 325 and vent reservoir 340), the valve configured to provide one or more channels between the aspiration conduit and the reservoir (fig. 3, vacuum relief valve 350 provides a channel along bypass conduit);
a first pressure sensor configured to detect a pressure associated with the surgical site (fig. 3, pressure sensor 365); and
a computer (360) configured to control the valve in response to the pressure detected by the one or more pressure sensors to mitigate a pressure change or a volume change (paragraph 0031).
Regarding claim 21, Sorensen discloses the device further comprising:
an aspiration pump (335) configured to create a vacuum pressure in the aspiration conduit to draw fluid through the aspiration conduit towards a drain reservoir (fig. 3, pump 335 to bring fluid to a drain bag 341); and
wherein the computer is further configured to control the valve to decrease the vacuum pressure in the aspiration conduit when the pressure associated with the surgical site is less than a first pressure threshold (paragraph 0010, “The controller may be configured to control the vacuum relief valve to stop the decrease of the vacuum pressure before the vacuum pressure reaches a vacuum level lower than -50 mmHg as measured at the eye.)
Regarding claim 22, Sorensen discloses wherein control the valve (350) to decrease the vacuum pressure by controlling the valve to provide the one or more channels to allow fluid from the reservoir to the aspiration conduit (paragraph 0042, “This movement of the fluid from the vent reservoir into the bypass conduit 345 alleviates or reduces the amount of vacuum pressure within the aspiration conduit 325”).
Regarding claim 23, Sorensen discloses the computer further configured to:
control the valve (350) to provide the one or more channels by providing a first channel from the reservoir to the aspiration pump or a second channel from the reservoir to an aspiration connector (fig. 3, bypass conduit 345 provided by valve 350 when valve is activated and leading from reservoir 340 to the end of aspiration line 325, wherein the end of the aspiration line connects to handpiece 112 and thus is an aspiration connector, paragraph 0029), the aspiration connector configured to couple to the handpiece (fig. 3, end of aspiration line 325 attached to handpiece 112).
Regarding claim 24, Sorensen discloses the computer further configured to:
control the valve (350) to provide the one or more channels by providing a first channel from the reservoir (340) to the aspiration pump (335) (fig. 3, vacuum relief valve 350 is in communication with bypass conduit 345, which creates a line of fluid communication to the pump 335, see annotated fig. 3 below) and a second channel from the reservoir (340) to an aspiration connector (fig. 3, bypass conduit 345 provided by valve 350 leading from reservoir 340 to end of aspiration line 325, wherein the end of the aspiration line connects to the handpiece 112 and is thus an aspiration connector, paragraph 0029), the aspiration connector configured to couple to the handpiece (fig. 3, end of aspiration line 325 attached to handpiece 112).
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Regarding claim 25, Sorensen discloses wherein the first pressure threshold has a value in the range of 0-207 mmHg (paragraph 0010, describing controlling the relief valve before vacuum hits a level lower than -50 mm Hg [or 50 mmHg absolute value])
Regarding claim 26, Sorensen discloses wherein the first pressure sensor (365) detects when the pressure associated with the surgical site is less than the first pressure threshold (paragraph 0010, “before the vacuum pressure reaches a vacuum level lower than -50 mmHg”).
Regarding claim 27, Sorensen discloses wherein the first pressure sensor comprises an irrigation pressure sensor configured to detect an irrigation pressure within the irrigation conduit (fig. 3, irrigation pressure sensor “IPS” along irrigation line, paragraph 0034, “the pressure sensor 365 is an irrigation pressure sensor 365 located along the irrigation conduit 315 within the handpiece 112. The irrigation pressure sensor detects the irrigation pressure within the irrigation conduit”).
Regarding claim 28, Sorensen discloses wherein the first pressure sensor comprising an irrigation pressure sensor configured to detect an irrigation pressure at the surgical site (fig. 3, pressure sensor 365 as an irrigation pressure sensor, paragraph 0034).
Regarding claim 29, Sorensen discloses the first pressure sensor located at the handpiece (fig. 3, pressure sensor 365 in handpiece 112 can detect pressure associated with surgical site, paragraph 0033, “from its location in the hand piece, the pressure sensor 365 detects a fluid pressure associated with the surgical site”).
Regarding claim 30, Sorensen discloses wherein the computer is further configured to:
control the valve to cease the decrease of the vacuum pressure in the aspiration conduit by controlling the valve to cease allowing the fluid after a predetermined period of time (paragraph 0035, “When the aspiration pressure sensor 330 detects that the aspiration pressure is greater than the second pressure threshold, then the controller 360 closes the vacuum relief valve 350 to control the rate of increase of the pressure within the aspiration conduit 325, and allows for the aspiration system to continue with normal operations after a period of time passes”).
Regarding claim 31, Sorensen discloses wherein the computer is further configured to:
control the valve to cease the decrease of the vacuum pressure in the aspiration conduit by controlling the valve to cease allowing the fluid when a diverter of the valve reaches a closing angle (fig. 3, valve 350 as a rotary valve, and the “diverter” is interpreted as the means of rotating the valve to be at an angle to allow fluid, paragraph 0047, “The method of FIG. 6 may be implemented when the vacuum relief valve 350 of FIG. 3 is a rotary valve that opens to a particular angular position. When the vacuum relief valve 350 reaches a predetermined angular setting, the controller 360 closes it.”).
Regarding claim 32, Sorensen discloses wherein the computer is further configured to:
control the valve to cease the decrease of the vacuum pressure in the aspiration conduit when the pressure associated with the surgical site reaches a second pressure threshold by controlling the valve to cease allowing the fluid paragraph 0032, “The controller 360 may include a first pressure threshold relating to the irrigation pressure as a representation of ocular pressure and a second pressure threshold relating to a minimum operating pressure or minimum vacuum pressure”, paragraph 0035, “when the aspiration pressure sensor 330 detects that the aspiration pressure is greater than the second pressure threshold, then the controller 360 closes the vacuum relief valve 350 to control the rate of increase of the pressure within the aspiration conduit 325…. Once the vacuum relief valve is closed, the vacuum pressure may increase (move away from atmospheric pressure) or remain the same”).
Regarding claim 33, Sorensen discloses wherein the second pressure threshold has a value in the range of 0 to 760 mmHg (paragraph 0036, “in some embodiments, the normal operating condition vacuum level is a vacuum greater than about -50 mmHg, and the vacuum level is controlled so as to not rise above -50 mmHg near the pump that creates vacuum in the aspiration line, as detected for example by the aspiration sensor… In some embodiments, the second pressure threshold is set to ensure the pressure does not rise over the pressures identified above”).
Regarding claim 34, Sorensen discloses wherein the system further comprises a second pressure sensor (330), the second pressure sensor (330) detects when the pressure associated with the surgical site reaches the second pressure threshold (fig. 3, aspiration pressure sensor 330, paragraph 0035, “When the aspiration pressure sensor 330 detects that the aspiration pressure is greater than the second pressure threshold”).
Regarding claim 35, Sorensen discloses wherein the second pressure sensor comprises an aspiration pressure sensor (330) configured to detect an aspiration pressure within the aspiration conduit (325) (fig. 3, aspiration pressure sensor 330 with aspiration line 325, paragraph 0043, “detecting the aspiration pressure with the aspiration pressure sensor 330 located along the aspiration conduit”).
Regarding claim 39, Sorensen discloses wherein the computer is further configured to control the valve to decrease the vacuum pressure in the aspiration conduit when the pressure associated with the surgical site is less than a first pressure threshold (paragraph 0010, “The controller may be configured to control the vacuum relief valve to stop the decrease of the vacuum pressure before the vacuum pressure reaches a vacuum level lower than -50 mmHg as measured at the eye.)
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.
Claim 36 is rejected under 35 U.S.C. 103 as being unpatentable over Sorensen in view of Suzuki (US 20080033349), and further in view of Hickey (US 20170224888).
Regarding claim 36, Sorensen, fails to teach wherein the reservoir is coupled with a pressure-vacuum source to manage a reservoir pressure of the reservoir, and wherein the pressure-vacuum source is configured to maintain the reservoir pressure of the reservoir at a specific pressure with a value in range of 0 to 500 mmHg.
However, Suzuki teaches an irrigation/aspiration apparatus for ocular use (abstract) wherein an irrigation bottle (10) used for venting an aspiration line (paragraph 009, a vent tube for making the irrigation liquid flow into the aspiration tube by releasing a control valve for reducing residual aspiration”, paragraph 0041), wherein the pressure of the irrigation bottle (10) is alterable (paragraph 0020, “The pole 12 is moved up and down by an up-and-down driving apparatus 14 and is capable of changing a height of the irrigation bottle 10. Irrigation pressure is adjusted so as to supply the patient’s eye E with the irrigation liquid at proper fluid pressure (quantity of flow or irrigation speed) according to the height at which the irrigation bottle 10 is set”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Sorensen such that the reservoir is coupled with a means of managing a reservoir pressure of the reservoir, as taught and suggested by Suzuki, for the purpose of providing a suitable structure that varies the pressure within the reservoir in order to vary the speed in which it vents the aspiration line.
Sorensen, as modified by Suzuki, fails to teach wherein the reservoir is coupled with a pressure-vacuum source to manage a reservoir pressure of the reservoir.
However, Hickey teaches an irrigation container (30) that is pressurized by a pressure supply (50), wherein the pressure supply may be any source known in the art to supply pressure to the irrigation source, such as peristaltic and pneumatic pumps (paragraph 0025). Further, Hickey teaches wherein a pressurizing source can be controlled (paragraph 0040, “the pressure supply 50 may be electronically controlled and monitored by the control module 60. The control module 60 may further measure and provide variables of the pressure supply 50 to a user or surgeon, and thereafter provide means for controlling the pressure supply”), and thus would be configured to pressurize the fluid to a variety of values.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system disclosed in Sorensen in view of Brody such that the means of managing a reservoir pressure is a pressure-vacuum source, wherein the pressure-vacuum source is configured to maintain the reservoir pressure of the reservoir at a specific pressure, as taught and suggested by Hickey, for the purpose of providing a suitable means that allows the user to actively control the pressure pressure-vacuum source that can be electronically controlled and monitored (see Hickey, paragraph 0040).
Sorensen, as modified by Hickey, is silent to wherein the specific pressure has a value in range of 0 to 500 mmHg.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system disclosed in Sorensen in view of Suzuki and Hickey such that the specific pressure has a value in the range of 0 to 500 mmHg for the purpose of providing a suitable value to pressurize the reservoir to allow it to exit into the system and decrease negative pressure therein, and since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. Further, applicant appears to place no criticality on the values within the range, stating they the reservoir pressure may be in the range of 0 to 500 mmHg (see application specification, paragraph 0037). In this instance, the device disclosed in either Hickey or Sorensen in view of Hickey, would not function differently is the specific pressure value was in the range of 0 to 500 mmHg.
Claims 37-38 are rejected under 35 U.S.C. 103 as being unpatentable over Sorensen.
Regarding claim 37, Sorensen fails to teach wherein the valve is located at the reservoir.
However, because the reservoir (330) is in direct fluid communication with the vacuum relief valve (350) (fig. 3, reservoir 330 in fluid path of relief valve 350), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system disclosed in Sorensen such that the valve is located at the reservoir for the purpose of providing a more compact assembly, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70. In this case, rearrangement would not change the functionality of the device disclosed in Sorensen for the valve to be located at the reservoir as opposed to on the bypass conduit, as the valve would allow fluid to exit the reservoir into the bypass conduit in either scenario.
Regarding claim 38, Sorensen discloses an aspiration connector that’s configured to couple to the handpiece (112) (fig. 3, end of aspiration line 325 serves as connector for handpiece 112), but fails to teach wherein the valve is located along the aspiration conduit and between an aspiration connector and the reservoir.
However, because the vacuum relief valve (350) and the bypass conduit (345) are in fluid communication with the aspiration line (325) (paragraph 0029, “a bypass conduit 345 is also in fluid communication with the aspiration line 325 and the vent reservoir 340 and bypasses the pump 335”), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system disclosed in Sorensen such that the valve is located along the aspiration conduit and between an aspiration connector and the reservoir, as well as modify the valve to additionally allow for aspiration through the aspiration conduit when the valve does not allow fluid from the vent reservoir into the aspiration line, for the purpose of providing a suitable location for the valve that still bypasses the pump (paragraph 0029) while still allowing the valve to control the flow of fluid, and since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.In this case, it would not change the functionality of the device disclosed in Sorensen for the valve to be located along the aspiration conduit and between an aspiration connector and the reservoir, as the valve is in fluid communication between the aspiration conduit and the reservoir in either scenario.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 20-34 and 36-39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 and 18 of U.S. Patent No. US 12144920 in view of Sorensen. The similarities between instant claim 20 and patented claim 1 are shown below.
Instant claim 20
Patented claim 1
An ophthalmic surgical system, comprising: an irrigation conduit in fluid communication with a handpiece and configured to carry fluid toward a surgical site; an aspiration conduit in fluid communication with the handpiece and configured to carry fluid away from the surgical site; a reservoir configured to hold fluid; a valve in fluid communication with the aspiration conduit and the reservoir, the valve configured to provide one or more channels between the aspiration conduit and the reservoir; a first pressure sensor configured to detect a pressure associated with the surgical site; and a computer configured to control the valve in response to the pressure detected by the one or more pressure sensors to mitigate a pressure change or a volume change.
A surgical system, comprising: an irrigation conduit in fluid communication with a handpiece and configured to carry fluid toward a surgical site; an aspiration conduit in fluid communication with the handpiece and configured to carry fluid away from the surgical site; an aspiration pump configured to create a vacuum pressure in the aspiration conduit to draw fluid through the aspiration conduit towards a drain reservoir; a venturi reservoir configured to hold fluid at a controlled reservoir pressure; a rotary valve located at the venturi reservoir; wherein the rotary valve comprises: one or more first channels to provide fluid communication between the venturi reservoir and the aspiration conduit; one or more second channels to provide fluid communication between the venturi reservoir and the aspiration pump; wherein at least one position of the rotary valve provides dual venting by providing fluid communication between the venturi reservoir and the aspiration conduit and fluid communication between the venturi reservoir and the aspiration pump, a first pressure sensor configured to detect a pressure associated with the surgical site, and a computer configured to control the rotary valve in response to the pressure detected by the first pressure sensor.
The patented claim does not teach that the valve mitigates a pressure change or a volume change.
However, Sorensen teaches wherein a similar valve is utilized to mitigate a pressure change or a volume change in response to a pressure detected by the pressure sensor (paragraph 0029)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the patented claim 1 such that the valve mitigates a pressure change or a volume change, as taught by Sorensen, for the purpose of providing a suitable means of decreasing the effects of occlusion surge (see Sorensen, paragraph 0029).
Regarding claim 21, the patented claim discloses the system further comprising: an aspiration pump configured to create a vacuum pressure in the aspiration conduit to draw fluid through the aspiration conduit towards a drain reservoir (claim 1), and wherein the computer is further configured to control the valve to decrease the vacuum pressure in the aspiration conduit when the pressure associated with the surgical site is less than a first pressure threshold (claim 2).
Regarding claim 22, the patented application discloses the computer further configured to: control the valve to decrease the vacuum pressure by controlling the valve to provide the one or more channels to allow fluid from the reservoir to the aspiration conduit (claim 3)
Regarding claim 23, the patented application discloses the computer further configured to: control the valve to provide the one or more channels by providing a first channel from the reservoir to the aspiration pump or a second channel from the reservoir to an aspiration connector, the aspiration connector configured to couple to the handpiece (claim 4).
Regarding claim 24, the patented application discloses the computer further configured to: control the valve to provide the one or more channels by providing a first channel from the reservoir to the aspiration pump and a second channel from the reservoir to an aspiration connector, the aspiration connector configured to couple to the handpiece (claim 5).
Regarding claim 25, the patented application discloses the first pressure threshold having a value in the range of 0 to 207 mmHg (claim 6).
Regarding claim 26, the patented application discloses wherein the first pressure sensor detects when the pressure associated with the surgical site is less than the first pressure threshold (claim 7)
Regarding claim 27, the patented application discloses the first pressure sensor comprising an irrigation pressure sensor configured to detect an irrigation pressure within the irrigation conduit (claim 8)
Regarding claim 28, the patented application discloses the first pressure sensor comprising an irrigation pressure sensor configured to detect an irrigation pressure at the surgical site (claim 9)
Regarding claim 29, the patented application the first pressure sensor located at the handpiece (claim 10)
Regarding claim 30, the patented application discloses the computer further configured to: control the valve to cease the decrease of the vacuum pressure in the aspiration conduit by controlling the valve to cease allowing the fluid after a predetermined period of time (claim 11)
Regarding claim 31, the patented application discloses the computer further configured to: control the valve to cease the decrease of the vacuum pressure in the aspiration conduit by controlling the valve to cease allowing the fluid when a diverter of the valve reaches a closing angle (claim 12)
Regarding claim 32, the patented application discloses the computer further configured to: control the valve to cease the decrease of the vacuum pressure in the aspiration conduit when the pressure associated with the surgical site reaches a second pressure threshold by controlling the valve to cease allowing the fluid (claim 13)
Regarding claim 33, the patented application discloses the second pressure threshold having a value in the range of 0 to 760 mmHg. (claim 14)
Regarding claim 34, the patented application discloses further comprising a second pressure sensor, the second pressure sensor detects when the pressure associated with the surgical site reaches the second pressure threshold (claim 15).
Regarding claim 35, the patented application discloses the second pressure sensor comprising an aspiration pressure sensor configured to detect an aspiration pressure within the aspiration conduit (claim 16).
Regarding claim 37, the patented application discloses the valve located at the reservoir (claim 19).
Regarding claim 38, the patented application discloses the valve located along the aspiration conduit and between an aspiration connector and the reservoir, the aspiration connector configured to couple to the handpiece (claim 19).
Regarding claim 39, the patented application discloses wherein the computer is further configured to control the valve to decrease a vacuum pressure in the aspiration conduit when the pressure associated with the surgical site is less than a first pressure threshold (claim 2).
Claim 36 is rejected on the ground of nonstatuatory double patenting as being unpatentable over claim 17 of U.S. Patent No. US 12144920 in view of Sorensen, and further in view of Suzuki and Hickey.
Regarding claim 36, the patented claim discloses the reservoir pressure of the reservoir at a specific pressure with a value in the range of 0 to 500 mmHg (claim 17), but does not teach wherein the reservoir is coupled with a pressure-vacuum source to manage a reservoir pressure of the reservoir; and wherein the pressure-vacuum source is configured to maintain the reservoir pressure of the reservoir at a specific pressure with a value in the range of 0 to 500 mmHg.
However, Suzuki teaches an irrigation/aspiration apparatus for ocular use (abstract) wherein an irrigation bottle (10) used for venting an aspiration line (paragraph 009, a vent tube for making the irrigation liquid flow into the aspiration tube by releasing a control valve for reducing residual aspiration”, paragraph 0041), wherein the pressure of the irrigation bottle (10) is alterable (paragraph 0020, “The pole 12 is moved up and down by an up-and-down driving apparatus 14 and is capable of changing a height of the irrigation bottle 10. Irrigation pressure is adjusted so as to supply the patient’s eye E with the irrigation liquid at proper fluid pressure (quantity of flow or irrigation speed) according to the height at which the irrigation bottle 10 is set”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in the patented claim such that the reservoir is coupled with a means of managing a reservoir pressure of the reservoir, as taught and suggested by Suzuki, for the purpose of providing a suitable structure that varies the pressure within the reservoir in order to vary the speed in which it vents the aspiration line.
The patented claim, as modified by Suzuki, fails to teach wherein the reservoir is coupled with a pressure-vacuum source to manage a reservoir pressure of the reservoir.
However, Hickey teaches an irrigation container (30) that is pressurized by a pressure supply (50), wherein the pressure supply may be any source known in the art to supply pressure to the irrigation source, such as peristaltic and pneumatic pumps (paragraph 0025). Further, Hickey teaches wherein a pressurizing source can be controlled (paragraph 0040, “the pressure supply 50 may be electronically controlled and monitored by the control module 60. The control module 60 may further measure and provide variables of the pressure supply 50 to a user or surgeon, and thereafter provide means for controlling the pressure supply”), and thus would be configured to pressurize the fluid to a variety of values.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system disclosed in Sorensen in view of Brody such that the means of managing a reservoir pressure is a pressure-vacuum source, wherein the pressure-vacuum source is configured to maintain the reservoir pressure of the reservoir at a specific pressure, as taught and suggested by Hickey, for the purpose of providing a suitable means that allows the user to actively control the pressure pressure-vacuum source that can be electronically controlled and monitored (see Hickey, paragraph 0040).
Claims 20-22, 26-30, 34-35, and 39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 and 4 of U.S. Patent No. US 11878105 in view of Sorensen. The similarities between instant claim 20 and patented claim 1 are demonstrated below.
Instant claim 20
Patented claim 1 of US 11878105
An ophthalmic surgical system, comprising: an irrigation conduit in fluid communication with a handpiece and configured to carry fluid toward a surgical site; an aspiration conduit in fluid communication with the handpiece and configured to carry fluid away from the surgical site; a reservoir configured to hold fluid; a valve in fluid communication with the aspiration conduit and the reservoir, the valve configured to provide one or more channels between the aspiration conduit and the reservoir; a first pressure sensor configured to detect a pressure associated with the surgical site; and a computer configured to control the valve in response to the pressure detected by the one or more pressure sensors to mitigate a pressure change or a volume change.
A surgical system, comprising: an irrigation conduit in fluid communication with a handpiece and configured to carry fluid toward a surgical site; an aspiration conduit in fluid communication with the handpiece and configured to carry fluid away from the surgical site; an aspiration pump configured to create a vacuum pressure in the aspiration conduit to draw fluid through the aspiration conduit towards a drain reservoir; a venturi reservoir configured to hold fluid at a controlled reservoir pressure; a valve fluidically coupled to the venturi reservoir; wherein the valve comprises: one or more first channels to provide fluid communication between the venturi reservoir and the aspiration conduit; one or more second channels to provide fluid communication between the venturi reservoir and the aspiration pump; a first pressure sensor configured to detect a pressure associated with the surgical site; and wherein the system is configured to control the valve in response to the pressure detected by the first pressure sensor.
The patented claim does not teach that the valve mitigates a pressure change or a volume change.
However, Sorensen teaches wherein a similar valve is utilized to mitigate a pressure change or a volume change in response to a pressure detected by the pressure sensor (paragraph 0029)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the patented claim 1 such that the valve mitigates a pressure change or a volume change, as taught by Sorensen, for the purpose of providing a suitable means of decreasing the effects of occlusion surge (see Sorensen, paragraph 0029).
Regarding claim 21, the patented claim discloses the system further comprising: an aspiration pump configured to create a vacuum pressure in the aspiration conduit to draw fluid through the aspiration conduit towards a drain reservoir (claim 1), and wherein the computer is further configured to control the valve to decrease the vacuum pressure in the aspiration conduit when the pressure associated with the surgical site is less than a first pressure threshold (claim 2).
Regarding claim 22, the patented application discloses the computer further configured to: control the valve to decrease the vacuum pressure by controlling the valve to provide the one or more channels to allow fluid from the reservoir to the aspiration conduit (claim 1)
Regarding claim 26, the patented application discloses wherein the first pressure sensor detects when the pressure associated with the surgical site is less than the first pressure threshold (claim 1)
Regarding claim 27, the patented application discloses the first pressure sensor comprising an irrigation pressure sensor configured to detect an irrigation pressure within the irrigation conduit (claim 4)
Regarding claim 28, the patented application discloses the first pressure sensor comprising an irrigation pressure sensor configured to detect an irrigation pressure at the surgical site (claim 1)
Regarding claim 29, the first pressure sensor located at the handpiece (claim 2)
Regarding claim 30, the patented application discloses the computer further configured to: control the valve to cease the decrease of the vacuum pressure in the aspiration conduit by controlling the valve to cease allowing the fluid after a predetermined period of time (claim 1)
Regarding claim 32, the patented application discloses the computer further configured to: control the valve to cease the decrease of the vacuum pressure in the aspiration conduit when the pressure associated with the surgical site reaches a second pressure threshold by controlling the valve to cease allowing the fluid (claim 1)
Regarding claim 34, the patented application discloses further comprising a second pressure sensor, the second pressure sensor detects when the pressure associated with the surgical site reaches the second pressure threshold (claim 1).
Regarding claim 35, the patented application discloses the second pressure sensor comprising an aspiration pressure sensor configured to detect an aspiration pressure within the aspiration conduit (claim 1).
Regarding claim 39, the patented application discloses wherein the computer is further configured to control the valve to decrease a vacuum pressure in the aspiration conduit when the pressure associated with the surgical site is less than a first pressure threshold (claim 1).
Claim 20 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 5 (encompassing the limitations of claim 1) of U.S. Patent No. 9549850.
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claim 5 appears to be a more specific version of instant claim 20, or in other words instant claim 20 is considered a more generic version of patented claim 5. The similarities of instant claim 20 and patented claim 5 are shown below.
Instant claim 20
Claim 5 of US 9549850
An ophthalmic surgical system, comprising: an irrigation conduit in fluid communication with a handpiece and configured to carry fluid toward a surgical site; an aspiration conduit in fluid communication with the handpiece and configured to carry fluid away from the surgical site; a reservoir configured to hold fluid; a valve in fluid communication with the aspiration conduit and the reservoir, the valve configured to provide one or more channels between the aspiration conduit and the reservoir; a first pressure sensor configured to detect a pressure associated with the surgical site; and a computer configured to control the valve in response to the pressure detected by the one or more pressure sensors to mitigate a pressure change or a volume change.
A surgical system comprising: a hand piece; an irrigation conduit in fluid communication with the hand piece and configured to carry fluid toward a surgical site; an aspiration conduit in fluid communication with the hand piece and configured to carry fluid away from the surgical site; a pump interfacing with the aspiration conduit, the pump configured to create a vacuum pressure in the aspiration conduit to draw fluid through the aspiration conduit; a vacuum relief valve in fluid communication with the aspiration conduit and configured to relieve the vacuum pressure in the aspiration conduit; a first pressure sensor disposed and configured to detect a pressure associated with the surgical site; a second pressure sensor located along the aspiration conduit, the second pressure sensor configured to monitor an aspiration pressure within the aspiration conduit; and a controller having a first pressure threshold and a second pressure threshold stored therein and being in communication with the vacuum relief valve, the first pressure sensor, and the second pressure sensor, the controller being configured to control the vacuum relief valve to partially open the vacuum relief valve to decrease the vacuum pressure in the aspiration conduit so that the vacuum pressure in the aspiration conduit decreases towards atmospheric pressure without reaching atmospheric pressure when the pressure detected by the first pressure sensor is less than the first pressure threshold, and the controller being configured to control the vacuum relief valve to close the vacuum relief valve when the pressure detected by the second pressure sensor is greater than the second pressure threshold, wherein an amount that the vacuum relief valve is partially opened is correlated to a difference between the first pressure threshold and the pressure detected by the second pressure sensor. [claim 1]
further comprising a vent reservoir and a bypass conduit bypassing the pump and in fluid communication with the aspiration conduit and the vent reservoir, wherein the vacuum relief valve is located along the bypass conduit, and wherein the vent reservoir is in fluid communication with the aspiration conduit [claim 4],
wherein the vacuum relief valve is configured to allow a vent reservoir fluid to enter the bypass conduit when the vacuum relief valve decreases the vacuum pressure in the aspiration conduit [claim 5].
Claim 20 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 5 (encompassing the limitations of claims 1 and 4) of U.S. Patent No. 10314953.
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claim 5 appears to be a more specific version of instant claim 20, or in other words instant claim 20 is considered a more generic version of patented claim 5. The similarities of instant claim 20 and patented claim 5 are shown below.
Instant claim 20
Claim 5 of US 10314953
An ophthalmic surgical system, comprising: an irrigation conduit in fluid communication with a handpiece and configured to carry fluid toward a surgical site; an aspiration conduit in fluid communication with the handpiece and configured to carry fluid away from the surgical site; a reservoir configured to hold fluid; a valve in fluid communication with the aspiration conduit and the reservoir, the valve configured to provide one or more channels between the aspiration conduit and the reservoir; a first pressure sensor configured to detect a pressure associated with the surgical site; and a computer configured to control the valve in response to the pressure detected by the one or more pressure sensors to mitigate a pressure change or a volume change.
A surgical system comprising: a hand piece; an aspiration conduit in fluid communication with the hand piece and configured to carry fluid away from a surgical site; a pump interfacing with the aspiration conduit, the pump configured to create a vacuum pressure in the aspiration conduit to draw fluid through the aspiration conduit; a vacuum relief valve in fluid communication with the aspiration conduit and configured to relieve the vacuum pressure in the aspiration conduit; a first pressure sensor disposed and configured to detect a pressure associated with the surgical site; a second pressure sensor located along the aspiration conduit, the second pressure sensor configured to monitor an aspiration pressure within the aspiration conduit; a vent reservoir and a bypass conduit bypassing the pump and in fluid communication with the aspiration conduit and the vent reservoir, wherein the vacuum relief valve is located along the bypass conduit, and wherein the vent reservoir is in fluid communication with the aspiration conduit; and a controller having a first pressure threshold and a second pressure threshold stored therein and being in communication with the vacuum relief valve, the first pressure sensor, and the second pressure sensor, the controller being configured to control the vacuum relief valve to open the vacuum relief valve to decrease the vacuum pressure in the aspiration conduit when the pressure detected by the first pressure sensor is less than the first pressure threshold, and the controller being configured to control the vacuum relief valve to close the vacuum relief valve, wherein a period of time that the vacuum relief valve is opened is correlated to a difference between the first pressure threshold and the pressure detected by the second pressure sensor [claim 1].
wherein the vacuum relief valve is configured to allow a vent reservoir fluid to enter the bypass conduit when the vacuum relief valve decreases the vacuum pressure in the aspiration conduit [claim 5].
Conclusion
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/Brandon W. Levy/Examiner, Art Unit 3781
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