DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 6/30/2025 and 7/30/are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
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) in view of Chen (US 2023/0064225 A1).
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);
a cutting edge disposed within the tube (guillotine end 312 of movable member 310, see Fig. 18 and Para. [0106]); and
a cannula (insertion member 110, see Fig. 8) having a first end configured to receive the tube (see Para. [0069] mentioning wherein the insertion member 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 position the cutting edge adjacent to the second end of the cannula 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 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]).
Regarding claim 2, the combination of Juan and Chen 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 of the probe device; 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 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 and Chen 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 edge is positioned adjacent to the second end of the cannula (see Chen Para. [0038]-[0040] and [0044]).
Regarding claim 4, the combination of Juan and Chen disclose the invention of claim 1.
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 6, the combination of Juan and Chen 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 and 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 position the cutting edge adjacent to a second end of 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 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]).
Regarding claim 8, the combination of Juan and Chen 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, as incorporated into the device of Juan, is a hollow tube positioned around the elongate tubular body of the probe) and positioned between the housing and the cutting port (see Chen Figs. 1A-1B showing wherein the stiffener extends between the proximal handle and distal tip of the elongate tubular body of the probe, 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 edge is positioned adjacent to the second end of the cannula (see Chen Para. [0038]-[0040] and [0044]).
Regarding claim 9, the combination of Juan and Chen 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, as incorporated into the device of Juan, comprises a hollow tube that encircles the elongate tubular body of the probe, the hollow tubular body constitutes a “receptacle” configured to hold the elongate tubular body of the probe); and the receptacle is configured to engage the cannula when the cutting edge 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 and 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
a stop configured to position the cutting edge adjacent to the second end of the cannula 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 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.
Regarding claim 11, the combination of Juan and Chen disclose all of the limitations of the invention of claim 10.
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 and Chen 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 and Chen 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, as incorporated into the device of Juan, comprises a hollow elongate tubular body coupled to the elongate tube of the probe device; 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 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 and Chen 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. 102(a)(1) as being anticipated by Juan (US 2004/0073231 A1) in view of Chen (US 2023/0064225 A1), further in view of Lopez (US 2012/0302961 A1).
Regarding claim 5, the combination of Juan and Chen 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, 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 a the surgical probe is inserted therethrough (see Lopez Para. [0024] and [0030]).
Regarding claim 15, the combination of Juan and Chen 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, 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 a 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 2022/0265469 A1 to Lambert, US 2021/0386583 A1 to Thyzel, US 2020/0375796 A1 to Reyes, US 10675181 B2 to Murakami, US 10376414 B2 to Hallen and US 2008/0021399 A1 to Spaide all disclose ophthalmic cutting devise comprising an outer guide sheath and inner reciprocating cutting member with either a depth stop member or electric-driven power source.
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.
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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.
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/M.B.H./Examiner, Art Unit 3771
/DARWIN P EREZO/Supervisory Patent Examiner, Art Unit 3771
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