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 Arguments
Applicant’s arguments with respect to claim(s) 1, 7 and 10 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Specifically, none of either
Juan (US 2004/0073231 A1) (previously of record) or Chen (US 2023/0064225 A1) (previously of record) are relied upon to disclose or suggest the amended limitations of “wherein the stop…configured to hold a position of the cutting port completely outside and adjacent to the second end of the cannula by a clearance distance between a proximal edge of the cutting port and a distal edge of the second end of the cannula in a range between 0.5 millimeters to 5 millimeters”.
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.
Claim(s) 1-4 and 6-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Juan (US 2004/0073231 A1) (previously of record) in view of Chen (US 2023/0064225 A1) (previously of record), further in view of Tamir (US 2026/0083589 A1), considered prior art due to a provisional application filed April 19, 2018.
Regarding claim 1, Juan discloses:
A system for eye surgery (see Fig. 17), the system comprising:
a probe (instrument 300; see Fig. 17) comprising:
a tube (inserted member 304; see Fig. 17) having a cutting port (side aperture 308; see Fig. 18; see also Para. [0106]);
a cutting edge disposed within the tube (guillotine end 312 of movable member 310; see Fig. 18; see also Para. [0106]) and configured to cut tissue entering the cutting port (see Para. [0107]; guillotine end 312 configured to cut tissue entering side aperture 308); and
a cannula (insertion member 110; see Fig. 8) having a first end configured to receive the tube (see Para. [0069]; insertion member 110 is configured to receive any of the disclosed probe embodiments) and a second end adapted for insertion into an eye (see Para. [0068]-[0069]).
However, Juan does not expressly disclose:
Wherein the probe comprises a stop configured to hold a position of the cutting port completely outside and adjacent to the second end of the cannula by a clearance distance between a proximal end of the cutting port and a distal edge of the second end of the cannula in a range between 0.5 millimeters to 5 millimeters when the tube is inserted into the cannula.
In the same field of endeavor, namely systems/probes for eye surgery, Chen teaches a system for eye surgery (see Fig. 1A) including a probe (probe 100; see Fig. 1A) comprising a cutting tube (tube 110; see Fig. 1A; see also Para. [0032] mentioning wherein tube 110 is an elongated cutting member); and a cannula (see Para. [0040] mentioning an insertion cannula used with the probe 100) configured to receive the cutting tube of the probe therein (see Para. [0032] and [0040]); wherein the probe comprises a stop (stiffener 132; see Fig. 1A; as the stiffener comprise a larger radial diameter compared to the elongate tubular sheath of the probe (see Para. [0038]), the stiffener is understood to constitute a “stop”; see also Para. [0038]-[0040] mentioning wherein the stiffener is configured to limit insertion depth of the cutting tube through the insertion cannula) configured to position the distal tip of the probe adjacent to the second end of the cannula when the tube is inserted into the cannula (see Para. [0039]-[0040]); wherein the stop is configured to limit the insertion depth of the probe into either a target site or into the insertion cannula (see Para. [0038]-[0040]); wherein the stop is further configured to variable adjust the stiffness level of the probe body (see Para. [0044]).
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 the instrument 300 of Juan to comprise an elongate tubular stiffener member coupled to and radially encircling the inserted member 304 as taught and suggested by Chen to, in this case, provide a variable stiffening element configured to be axially translatable to achieve a desired stiffness imparted onto the inserted member (see Chen Para. [0038]-[0040] and [0044]). Further, the stiffener of Chen would additionally aid in limiting the insertion depth to which the inserted member of Juan may be inserted to a target site by abutment of the radially-enlarged surface area of the stiffener coming into contact with the body of the insertion member (see Chen Para. [0038]-[0040]).
However, while Chen discloses wherein the stiffener stop member, as incorporated into the instrument of Juan, may variably limit the insertion depth to which the inserted member of Juan may be inserted to a target site (i.e., a distance beyond the distal end of the insertion member/cannula), none of either Juan or Chen expressly disclose a specific/exemplary insertion depth for which the inserted member/tube be positioned relative to the distal end of the insertion member/cannula. The combination thus does not expressly disclose wherein the stop of the probe is configured to hold a position of the distal cutting port completely outside and adjacent to the second end of the cannula by a clearance distance between a proximal end of the cutting port and a distal edge of the second end of the cannula in a range between 0.5 millimeters to 5 millimeters.
In the same field of endeavor, namely systems/probes for eye surgery, Tamir teaches a system for eye surgery (see Figs. 6A-6B) including an inserted cutting tube (needle shaft 122; see Figs. 6A-6B) comprising a cutter at the distal end thereof (distal tip 128; see Fig. 8A; see also Para. [0085]); and an insertion cannula (external stopper 123; see Figs. 6A-6B) configured to receive the inserted cutting tube therein (see Figs. 6A-8C); wherein the inserted cutting tube’s insertion depth beyond the distal end of the insertion cannula is limited to between 1mm and 3mm (see Para. [0090]).
As the combination of Juan and Chen are silent in regard to a specific insertion depth for the inserted member/tube, one of ordinary skill in the art would have looked to relevant prior art for known clearance distances an eye surgery probe may extend beyond a respective insertion member/cannula. It would have therefore been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the stiffener stop of Juan, as incorporated from the teachings of Chen, to limit the insertion depth of the distal end of the inserted member 304 (i.e., the portion containing the side aperture 308) beyond the distal end of the insertion member 110 to between 1mm and 3mm as disclosed to be a known workable insertion depth for a surgical ocular cutting device to extend beyond the distal end of a respective insertion tube by Tamir. Further, as applicant appears to have placed no criticality on the claimed range (see Specification Para. [0053] and [0057] indicating the clearance distance may be between 0.5 to 5mm but may also include other distance outside of this claimed range) it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 2, the combination of Juan, Chen and Tamir disclose the invention of claim 1, Juan, as modified by Chen, further discloses wherein: the stop comprises a receptacle coupled to the tube (see Chen Fig. 1A-1B showing wherein the stiffener, as incorporated into the device of Juan, comprises a hollow elongate tubular body coupled to the elongate tube 110 of the probe device 100; the hollow elongate body constitutes a “receptacle”); and the cannula comprises a latch (top surface of stop member 112 immediately adjacent the aperture 116; see Examiner’s Diagram of Juan Fig. 8 below) configured to engage the receptacle when the cutting port is positioned adjacent to the second end of the cannula (see Chen Para. [0038]-[0040] mentioning wherein the larger radial diameter of the stiffener member, as incorporated into the device of Juan, is configured to abut against the outer surface of the insertion cannula which prevents the stiffener member from being further inserted therein unless a user applies additional force to retract the stiffener member; this “stop” system enables the top surface of the stop member of Juan to act as a “latch” to prevent the stiffener member from being inserted therethrough).
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Examiner’s Diagram of Juan Fig. 8
Regarding claim 3, the combination of Juan, Chen and Tamir disclose the invention of claim 1, Juan, as modified by Chen, further discloses wherein: the stop comprises a sleeve disposed around the tube (see Chen Fig. 1A-1B); and the sleeve is configured to contact the first end of the cannula when the cutting port is positioned adjacent to the second end of the cannula (see Chen Para. [0038]-[0040] and [0044]).
Regarding claim 4, the combination of Juan, Chen and Tamir disclose the invention of claim 1.
However, the combination as currently presented does not expressly disclose wherein the second end of the cannula comprises a valve; and the valve is normally closed and configured to be opened when the tube is inserted through the second end.
Chen further teaches wherein the insertion cannula comprises a valve (see Para. [0040] and [0049]); wherein the valve is normally closed and configured to be opened when the tube is inserted through the second end of the cannula (see Para. [0040] and [0049]; as the purpose of a valve is to control the flow or passage of material therethrough, the valve of Chen is understood to be closed until the elongate tubular body of the probe device is inserted therethrough).
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 the insertion member 110 of Juan to comprise a valve at the proximal end thereof as taught and suggested by Chen to, in this case, provide a seal at the proximal entry point of the insertion member 110 that may be selectively opened when the inserted member 304 is passed therethrough (see Chen Para. [0040] and [0049]).
Regarding claim 6, the combination of Juan, Chen and Tamir disclose the invention of claim 1, Juan, as modified by Chen, further discloses wherein the stop is spring biased (see Chen Para. [0049]) and the probe further comprises a de-coupler and a control member configured to selectively allow the stop to be locked in a retracted position (see Chen Para. [0030] and [0039]).
Regarding claim 7, Juan discloses:
An apparatus for clearing tissue from a cannula (see Fig. 17), the apparatus comprising:
a housing (proximal handle portion; see Fig. 17);
an actuator disposed within the housing (see Para. [0107] and [0109] mentioning wherein movement of the cutter head 330 results in axial translation of the moveable member 310, indicating an actuation mechanism and/or linkage connecting the two components within the housing of the proximal handle);
a first tube (inserted member 304; see Fig. 17) coupled to the housing and extending from the housing (see Fig. 17), the first tube comprising a cutting port (side aperture 308; see Para. [0107]-[0109]) configured to be inserted into a first end of the cannula (see Para. [0068]-[0069] mentioning wherein the ophthalmic probe devices are configured to be inserted through insertion member 110);
a second tube (movable member 310; see Fig. 18) disposed within the first tube (see Fig. 18), the second tube comprising a cutting edge at least partially exposed through the cutting port (guillotine 312; see Fig. 18; see also Para. [107]-[0109]); and
wherein the actuator is configured to oscillate the second tube within the first tube such that the cutting edge is operable to cut tissue entering the cutting port adjacent to the second end of the cannula (see Para. [0107]-[0109]).
However, Juan does not expressly disclose a stop configured to hold a position of the cutting port completely outside and adjacent to a second end of the cannula by a clearance distance between a proximal edge of the cutting port and a distal edge of the second end of the cannula in a range between 0.5 millimeters to 5 millimeters.
In the same field of endeavor, namely systems/probes for eye surgery, Chen teaches a system for eye surgery (see Fig. 1A) including a probe (probe 100; see Fig. 1A) comprising a cutting tube (tube 110; see Fig. 1A; see also Para. [0032] mentioning wherein tube 110 is an elongated cutting member); and a cannula (see Para. [0040] mentioning an insertion cannula used with the probe 100) configured to receive the cutting tube of the probe therein (see Para. [0032] and [0040]); wherein the probe comprises a stop (stiffener 132; see Fig. 1A; as the stiffener comprise a larger radial diameter compared to the elongate tubular sheath of the probe (see Para. [0038]), the stiffener is understood to constitute a “stop”; see also Para. [0038]-[0040] mentioning wherein the stiffener is configured to limit insertion depth of the cutting tube through the insertion cannula) configured to position the distal tip of the probe adjacent to the second end of the cannula when the tube is inserted into the cannula (see Para. [0039]-[0040]); wherein the stop is configured to limit the insertion depth of the probe into either a target site or into the insertion cannula (see Para. [0038]-[0040]); wherein the stop is further configured to variable adjust the stiffness level of the probe body (see Para. [0044]).
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 the instrument 300 of Juan to comprise an elongate tubular stiffener member coupled to and radially encircling the inserted member 304 as taught and suggested by Chen to, in this case, provide a variable stiffening element configured to be axially translatable to achieve a desired stiffness imparted onto the inserted member (see Chen Para. [0038]-[0040] and [0044]). Further, the stiffener of Chen would additionally aid in limiting the insertion depth to which the inserted member of Juan may be inserted to a target site by abutment of the radially-enlarged surface area of the stiffener coming into contact with the body of the insertion member (see Chen Para. [0038]-[0040]).
However, while Chen discloses wherein the stiffener stop member, as incorporated into the instrument of Juan, may variably limit the insertion depth to which the inserted member of Juan may be inserted to a target site (i.e., a distance beyond the distal end of the insertion member/cannula), none of either Juan or Chen expressly disclose a specific/exemplary insertion depth for which the inserted member/tube be positioned relative to the distal end of the insertion member/cannula. The combination thus does not expressly disclose wherein the stop of the probe is configured to hold a position of the distal cutting port completely outside and adjacent to the second end of the cannula by a clearance distance between a proximal end of the cutting port and a distal edge of the second end of the cannula in a range between 0.5 millimeters to 5 millimeters.
In the same field of endeavor, namely systems/probes for eye surgery, Tamir teaches a system for eye surgery (see Figs. 6A-6B) including an inserted cutting tube (needle shaft 122; see Figs. 6A-6B) comprising a cutter at the distal end thereof (distal tip 128; see Fig. 8A; see also Para. [0085]); and an insertion cannula (external stopper 123; see Figs. 6A-6B) configured to receive the inserted cutting tube therein (see Figs. 6A-8C); wherein the inserted cutting tube’s insertion depth beyond the distal end of the insertion cannula is limited to between 1mm and 3mm (see Para. [0090]).
As the combination of Juan and Chen are silent in regard to a specific insertion depth for the inserted member/tube, one of ordinary skill in the art would have looked to relevant prior art for known clearance distances an eye surgery probe may extend beyond a respective insertion member/cannula. It would have therefore been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the stiffener stop of Juan, as incorporated from the teachings of Chen, to limit the insertion depth of the distal end of the inserted member 304 (i.e., the portion containing the side aperture 308) beyond the distal end of the insertion member 110 to between 1mm and 3mm as disclosed to be a known workable insertion depth for a surgical ocular cutting device to extend beyond the distal end of a respective insertion tube by Tamir. Further, as applicant appears to have placed no criticality on the claimed range (see Specification Para. [0053] and [0057] indicating the clearance distance may be between 0.5 to 5mm but may also include other distance outside of this claimed range) it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 8, the combination of Juan, Chen and Tamir disclose the invention of claim 7, Juan, as modified by Chen, further discloses wherein: the stop comprises a sleeve disposed around the first tube (see Chen Figs. 1A-1B showing wherein the stiffener 132, as incorporated into the device of Juan, is a hollow tube positioned around the elongate tubular body 110 of the probe 100) and positioned between the housing and the cutting port (see Chen Figs. 1A-1B showing wherein the stiffener 132 extends between the proximal handle and distal tip of the elongate tubular body 110 of the probe 100, terminating less than halfway along the length of the elongate tubular body); and the sleeve is configured to contact the first end of the cannula when the cutting port is positioned adjacent to the second end of the cannula (see Chen Para. [0038]-[0040] and [0044]).
Regarding claim 9, the combination of Juan, Chen and Tamir disclose the invention of claim 7, Juan, as modified by Chen, further discloses wherein: the stop comprises a receptacle coupled to the first tube (see Chen Figs. 1A-1B showing wherein the stiffener 132, as incorporated into the device of Juan, comprises a hollow tube that encircles the elongate tubular body 110 of the probe 100, the hollow tubular body constitutes a “receptacle” configured to hold the elongate tubular body 110 of the probe 100); and the receptacle is configured to engage the cannula when the cutting port is positioned adjacent to the second end of the cannula (see Chen Para. [0038]-[0040] and [0044]).
Regarding claim 10, Juan discloses:
A system for eye surgery (see Fig. 17), the system comprising:
a cannula having a first end and a second end (insertion member 110; see Fig. 8; see also Para. [0068]-[0069] mentioning wherein the insertion member is configured to receive the ophthalmic probe devices of the disclosed invention);
a controller (cutter head 330; see Fig. 17; see also Para. [0107]-[0109]);
an actuator coupled to the driver (movable member 310; see Figs. 17-18);
a cutting edge coupled to the actuator (guillotine 312; see Figs. 17-18; see also Para. [0107]-[0109]); and
wherein: the second end of the cannula is adapted for insertion into an eye (see Para. [0068]-[0070]), the cutting edge is configured to be inserted into the first end of the cannula (see Para. [0068]-[0069] mentioning wherein the ophthalmic probe devices are configured to be inserted into insertion member 110), and the controller is configured to cause the actuator to oscillate the cutting edge to cut tissue adjacent to the second end of the cannula (see Para. [0107]-[0109]).
However, while Juan discloses wherein cutter head 330 is configured to cause axial reciprocation of the movable member to make up to 1,000 cuts per minute (see Para. [0109]), Juan does not provide adequate disclosure pertaining to the drive mechanism and thus does not expressly disclose:
a power source;
a driver couped to the power source and the controller; and additionally,
a stop configured to hold a position of the cutting edge completely outside and adjacent to the second end of the cannula by a clearance distance between a proximal edge of a cutting portion through which the cutting edge is at least partially exposed and a distal edge of the cannula in a range between 0.5 millimeters and 5 millimeters when the cutting edge is inserted into the cannula.
In the same field of endeavor, namely systems/probes for eye surgery, Chen teaches a system for eye surgery (see Fig. 1A) including a probe (probe 100; see Fig. 1A) comprising a cutting tube (tube 110; see Fig. 1A; see also Para. [0032] mentioning wherein tube 110 is an elongated cutting member); and a cannula (see Para. [0040] mentioning an insertion cannula used with the probe 100) configured to receive the cutting tube of the probe therein (see Para. [0032] and [0040]); wherein the probe comprises a stop (stiffener 132; see Fig. 1A; as the stiffener comprise a larger radial diameter compared to the elongate tubular sheath of the probe (see Para. [0038]), the stiffener is understood to constitute a “stop”; see also Para. [0038]-[0040] mentioning wherein the stiffener is configured to limit insertion depth of the cutting tube through the insertion cannula) configured to position the distal tip of the probe adjacent to the second end of the cannula when the tube is inserted into the cannula (see Para. [0039]-[0040]); wherein the stop is configured to limit the insertion depth of the probe into either a target site or into the insertion cannula (see Para. [0038]-[0040]); wherein the stop is further configured to variable adjust the stiffness level of the probe body (see Para. [0044]).
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 the instrument 300 of Juan to comprise an elongate tubular stiffener member coupled to and radially encircling the inserted member 304 as taught and suggested by Chen to, in this case, provide a variable stiffening element configured to be axially translatable to achieve a desired stiffness imparted onto the inserted member (see Chen Para. [0038]-[0040] and [0044]). Further, the stiffener of Chen would additionally aid in limiting the insertion depth to which the inserted member of Juan may be inserted to a target site by abutment of the radially-enlarged surface area of the stiffener coming into contact with the body of the insertion member (see Chen Para. [0038]-[0040]).
Chen further discloses an actuation mechanism for axially reciprocating the cutting tube of the probe device, the actuation mechanism comprising: a power source (see Para. [0035] mentioning an electric power source configured to supply power to a drive system for reciprocating the cutting probe) and a driver coupled to the power source and the cutting probe tip (see Para. [0035]) to allow for repeated rapid axial translation of the cutting probe tip (see Para. [0035]).
Since Juan discloses wherein the movable member is configured to reciprocate to make 1,000 cuts per minute, but does not provide a detailed disclosure of the system responsible for the rapid reciprocation rate, it would have further been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the system for causing axil translation of the movable member of Juan to comprise an electronically-driven actuation system including an electrical power source and a drive mechanism coupling the cutter head to the movable member as disclosed by Chen to, in this case, provide a known actuation system within the prior art to cause axial reciprocation of the movable member and cutting tip located at the distal end thereof to be able to reciprocate at the disclosed 1,000 cuts per minute.
However, while Chen discloses wherein the stiffener stop member, as incorporated into the instrument of Juan, may variably limit the insertion depth to which the inserted member of Juan may be inserted to a target site (i.e., a distance beyond the distal end of the insertion member/cannula), none of either Juan or Chen expressly disclose a specific/exemplary insertion depth for which the inserted member/tube be positioned relative to the distal end of the insertion member/cannula. The combination thus does not expressly disclose wherein the stop of the probe is configured to hold a position of the distal cutting port completely outside and adjacent to the second end of the cannula by a clearance distance between a proximal end of the cutting port and a distal edge of the second end of the cannula in a range between 0.5 millimeters to 5 millimeters.
In the same field of endeavor, namely systems/probes for eye surgery, Tamir teaches a system for eye surgery (see Figs. 6A-6B) including an inserted cutting tube (needle shaft 122; see Figs. 6A-6B) comprising a cutter at the distal end thereof (distal tip 128; see Fig. 8A; see also Para. [0085]); and an insertion cannula (external stopper 123; see Figs. 6A-6B) configured to receive the inserted cutting tube therein (see Figs. 6A-8C); wherein the inserted cutting tube’s insertion depth beyond the distal end of the insertion cannula is limited to between 1mm and 3mm (see Para. [0090]).
As the combination of Juan and Chen are silent in regard to a specific insertion depth for the inserted member/tube, one of ordinary skill in the art would have looked to relevant prior art for known clearance distances an eye surgery probe may extend beyond a respective insertion member/cannula. It would have therefore been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the stiffener stop of Juan, as incorporated from the teachings of Chen, to limit the insertion depth of the distal end of the inserted member 304 (i.e., the portion containing the side aperture 308) beyond the distal end of the insertion member 110 to between 1mm and 3mm as disclosed to be a known workable insertion depth for a surgical ocular cutting device to extend beyond the distal end of a respective insertion tube by Tamir. Further, as applicant appears to have placed no criticality on the claimed range (see Specification Para. [0053] and [0057] indicating the clearance distance may be between 0.5 to 5mm but may also include other distance outside of this claimed range) it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 11, the combination of Juan, Chen and Tamir disclose all of the limitations of the invention of claim 10.
However, the combination as currently presented does not expressly disclose wherein the second end of the cannula comprises a valve; and the valve is normally closed and configured to be opened when the tube is inserted through the second end.
Chen further teaches wherein the insertion cannula comprises a valve (see Para. [0040] and [0049]); wherein the valve is normally closed and configured to be opened when the tube is inserted through the second end of the cannula (see Para. [0040] and [0049]; as the purpose of a valve is to control the flow or passage of material therethrough, the valve of Chen is understood to be closed until the elongate tubular body of the probe device is inserted therethrough).
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 the insertion member of Juan to comprise a valve at the proximal end thereof as taught and suggested by Chen to, in this case, provide a seal at the proximal entry point of the insertion member that may be selectively opened when the inserted member is passed therethrough (see Chen Para. [0040] and [0049]).
Regarding claim 12, the combination of Juan, Chen and Tamir disclose the invention of claim 10, Juan further discloses a tube enclosing the cutting edge (inserted member 304; see Figs. 17-18), the tube configured to be inserted into the first end of the cannula (see Para. [0068]-[0070]).
Regarding claim 13, the combination of Juan, Chen and Tamir disclose the invention of claim 12, Juan, as modified by Chen, further discloses wherein: the stop comprises a receptacle coupled to the tube (see Chen Fig. 1A-1B showing wherein the stiffener 132, as incorporated into the device of Juan, comprises a hollow elongate tubular body coupled to the elongate tube 110 of the probe device 100; the hollow elongate body constitutes a “receptacle”); and the cannula comprises a latch (top surface of stop member 112 immediately adjacent the aperture 116, see Examiner’s Diagram of Juan Fig. 8 below) configured to engage the receptacle when the cutting edge is positioned adjacent to the second end of the cannula (see Chen Para. [0038]-[0040] mentioning wherein the larger radial diameter of the stiffener 132 member, as incorporated into the device of Juan, is configured to abut against the outer surface of the insertion cannula which prevents the stiffener member from being further inserted therein unless a user applies additional force to retract the stiffener member; this “stop” system enables the top surface of the stop member of Juan to act as a “latch” to prevent the stiffener member from being inserted therethrough).
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Examiner’s Diagram of Juan Fig. 8
Regarding claim 14, the combination of Juan, Chen and Tamir disclose the invention of claim 12, Juan, as modified by Chen, further discloses wherein: the stop comprises a sleeve disposed around the tube (see Chen Fig. 1A-1B); and the sleeve is configured to contact the first end of the cannula when the cutting edge is positioned adjacent to the second end of the cannula (see Chen Para. [0038]-[0040] and [0044]).
Claim(s) 5 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Juan (US 2004/0073231 A1) (previously of record) in view of Chen (US 2023/0064225 A1) (previously of record) further Tamir (US 2026/0083589 A1), further in view of Lopez (US 2012/0302961 A1) (previously of record).
Regarding claim 5, the combination of Juan, Chen and Tamir disclose the invention of claim 1, Juan, as modified by Chen, further discloses wherein: the stop comprises a sleeve disposed around the tube (see Chen Figs. 1A-1B showing wherein the stiffener 132, as incorporated into the device of Juan, is in the form of a sleeve); the sleeve is configured to contact the first end of the cannula when the cutting port is positioned adjacent to the second end of the cannula (see Chen Para. [0038]-[0040] and [0044]).
However, while Chen further discloses wherein a valve is present on the proximal end of the insertion cannula (see Para. [0040] and [0049]), Chen does not expressly disclose any particular type of valve and thus does not expressly disclose wherein the second end of the cannula comprises a slit valve; and the slit valve is normally closed and configured to be opened when the tube is inserted through the second end.
In the same field of endeavor, namely insertion cannulas for ophthalmic devices, Lopez teaches a surgical insertion cannula (see Figs. 1-2) comprising a valve (seal 111; see Figs. 1-2) located at the proximal end thereof (see Figs. 1-2); wherein the valve is in the form of a slit valve (slit 113 of valve seal 111; see Figs. 1-2); wherein then no instrument is passed through the seal, the seal remains closed, preventing fluids or material from passing therethrough (see Para. [0024] and [0030]).
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 the insertion member of Juan to comprise a slit valve seal at the proximal end thereof as taught and suggested by Lopez to, in this case, prevent material flow through the insertion member until the surgical probe is inserted therethrough (see Lopez Para. [0024] and [0030]).
Regarding claim 15, the combination of Juan, Chen and Tamir disclose the invention of claim 12, Juan, as modified by Chen, further discloses wherein: the stop comprises a sleeve disposed around the tube (see Chen Figs. 1A-1B showing wherein the stiffener 132, as incorporated into the device of Juan, is in the form of a sleeve); the sleeve is configured to contact the first end of the cannula when the cutting edge is positioned adjacent to the second end of the cannula (see Chen Para. [0038]-[0040] and [0044]).
However, while Chen further discloses wherein a valve is present on the proximal end of the insertion cannula (see Para. [0040] and [0049]), Chen does not expressly disclose any particular type of valve and thus does not expressly disclose wherein the second end of the cannula comprises a slit valve; and the slit valve is normally closed and configured to be opened when the tube is inserted through the second end.
In the same field of endeavor, namely insertion cannulas for ophthalmic devices, Lopez teaches a surgical insertion cannula (see Figs. 1-2) comprising a valve (seal 111; see Figs. 1-2) located at the proximal end thereof (see Figs. 1-2); wherein the valve is in the form of a slit valve (slit 113 of valve seal 111; see Figs. 1-2); wherein then no instrument is passed through the seal, the seal remains closed, preventing fluids or material from passing therethrough (see Para. [0024] and [0030]).
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 the insertion member of Juan to comprise a slit valve seal at the proximal end thereof as taught and suggested by Lopez to, in this case, prevent material flow through the insertion member until the surgical probe is inserted therethrough (see Lopez Para. [0024] and [0030]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s
disclosure. See the attached PTO-892 Notice of References Cited. Specifically, US 2021/0353455 A1 to Tumlinson, US 2024/0350308 A1 to Calhoun, US 2011/0015658 A1 to Vijfvinkel, US 2026/0026682 A1 to Cardamone and US 2023/0098330 A1 to Pournaras all disclose surgical ocular cutting devices and/or accompanying disclosures of exemplary insertion depths beyond the distal end of an introducer member.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MITCHELL B HOAG whose telephone number is (571)272-0983. The examiner can normally be reached 7:30 - 5:00 M-F.
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, Darwin Erezo can be reached at 5712724695. 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.
/M.B.H./Examiner, Art Unit 3771
/DARWIN P EREZO/Supervisory Patent Examiner, Art Unit 3771
