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 .
Claim Rejections - 35 USC § 102
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 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 1-5 and 8-20 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C 102(a)(2) as being anticipated by Chu (U.S. PGPub No. 2018/0199799).
In regards to claim 1, Chu discloses an assembly for engaging a medical device shaft, comprising an assembly body defining a channel adapted to accommodate the medical device shaft extending therethrough, the assembly body adapted to be held in a person's hand ([0006]: "In one example, a device may include a first portion coupled to a shaft of an insertable medical device.", [0024]: "Handle 12 of insertion device 10 may have any shape suitable for gripping and controlling insertion device 10. For example, handle 12 may have an ergonomic shape designed to be held comfortably in the hand, e.g., the palm of the hand of a medical professional."), an engagement feature on the assembly body adapted to selectively engage an engagement member secured on the medical device shaft ([0040]: "As noted in each of the arrangements of FIGS. 1-4, first portion 32 is fixedly coupled to shaft 14. That is, first portion 32 may be glued, welded, or otherwise fixedly coupled to (e.g., axially fixed and not moveable along the length of) shaft 14. In an alternative arrangement, as shown in FIG. 5, a first portion 132 of a force indicator 130 may be selectively coupleable and uncoupleable from shaft 14."), wherein the engagement feature is movable between an open configuration in which the engagement feature does not engage the engagement member and a closed configuration in which the engagement feature engages the engagement member ([0028]: "Additionally, force indicator 30 includes a second portion 34 moveable with respect to shaft 14 (e.g., not fixedly coupled to shaft 14, and is axially moveable along the length of shaft 14).").
In regards to claim 2, Chu discloses that the engagement feature comprises a first engagement feature element molded into the assembly body, the first engagement feature element biased into the open configuration and a second engagement feature slidingly disposed relative to the first engagement feature such that sliding the second engagement feature over the first engagement feature element moves the first engagement feature element into the closed configuration ([0040]: "As noted in each of the arrangements of FIGS. 1-4, first portion 32 is fixedly coupled to shaft 14. That is, first portion 32 may be glued, welded, or otherwise fixedly coupled to (e.g., axially fixed and not moveable along the length of) shaft 14. In an alternative arrangement, as shown in FIG. 5, a first portion 132 of a force indicator 130 may be selectively coupleable and uncoupleable from shaft 14.").
In regards to claim 3, Chu discloses a lever pivotably secured to the assembly body, the engagement feature comprising a tab extending towards the channel, the tab extending into the channel when the engagement feature is in the closed configuration ([0028]: "For example, first portion 32 includes a lumen (not shown) extending therethrough within which shaft 14 is received and secured.").
In regards to claim 4, Chu discloses the assembly body comprises a first assembly body half extending from a assembly body midpoint, a second assembly body half extending from the assembly body midpoint ([0031]: "For example, in some arrangements, second grip portion 34A may extend along about three fourths, about half, or about a quarter of the entire length of the radially external surface of second portion 34."), the engagement feature comprises a first engagement feature element disposed within the first assembly body half ([0028]: "Additionally, force indicator 30 includes a second portion 34 moveable with respect to shaft 14 (e.g., not fixedly coupled to shaft 14, and is axially moveable along the length of shaft 14)."), and a second engagement feature element disposed within the second assembly body half, wherein the first assembly body half and the second assembly body half are biased to a configuration in which the first engagement feature element and the second engagement feature element are spaced apart in the open configuration, 'and wherein the first assembly body half and the second assembly body half are adapted to be squeezed together in order to move the first engagement feature element and the second engagement feature element together into the closed configuration ([0031]: "While each of first portion 32 and second portion 34 are illustrated to include a grip portion, e.g., first grip portion 32A and second grip portion 34A, respectively, in some arrangements, only one or neither of first portion 32 and second portion 34 may include such a grip portion.").
In regards to claim 5, Chu discloses that the engagement feature comprises a spring- loaded collet disposed within the channel that is adapted to push against one or more ramp surfaces within the assembly body, wherein the spring-loaded collet opens to accommodate the engagement member as the engagement member passes, then closes to hold engagement member ([0032]: "Stop 34B may include a radially narrowed or tapered flange forming an abutment for an elastic member or spring 40 (e.g., a helical compression spring). Spring 40 is positioned radially between first portion 32 and second portion 34. That is, spring 40 may be positioned about (e.g., radially outwardly of a longitudinal axis of first portion 32) base portion 32C of first portion 32, and radially inwardly of and/or within the lumen of second portion 34. A proximal end of spring 40 abuts transition portion 32B of first portion 32 while a distal end of spring 40 abuts stop 34B of second portion 34. In such a manner, movement of second portion 32 relative to first portion 32 compresses or stresses spring 40.").
In regards to claim 8, Chu discloses that the assembly body comprises: a first assembly body section ([0006]: "In one example, a device may include a first portion coupled to a shaft of an insertable medical device.", [0024]: "Handle 12 of insertion device 10 may have any shape suitable for gripping and controlling insertion device 10. For example, handle 12 may have an ergonomic shape designed to be held comfortably in the hand, e.g., the palm of the hand of a medical professional."), a second assembly body section hingedly coupled to the first assembly body section, the engagement feature includes a first engagement feature element disposed within the first assembly body section and a second engagement feature element disposed within the second assembly body section, wherein the second housing section is adapted to pivot away from the first assembly body section in the open configuration and to pivot towards the first assembly body section in the closed configuration.([0040]: "As noted in each of the arrangements of FIGS. 1-4, first portion 32 is fixedly coupled to shaft 14. That is, first portion 32 may be glued, welded, or otherwise fixedly coupled to (e.g., axially fixed and not moveable along the length of) shaft 14. In an alternative arrangement, as shown in FIG. 5, a first portion 132 of a force indicator 130 may be selectively coupleable and uncoupleable from shaft 14.").
In regards to claim 9, Chu discloses that the second assembly body section is hingedly coupled to the first assembly body section via a living hinge ([0040]: "As noted in each of the arrangements of FIGS. 1-4, first portion 32 is fixedly coupled to shaft 14. That is, first portion 32 may be glued, welded, or otherwise fixedly coupled to (e.g., axially fixed and not moveable along the length of) shaft 14. In an alternative arrangement, as shown in FIG. 5, a first portion 132 of a force indicator 130 may be selectively coupleable and uncoupleable from shaft 14.").
In regards to claim 10, Chu discloses that the first engagement feature element and the second engagement feature element are each disposed at an end of the assembly body opposite that of the living hinge ([0024]: "For example, handle 12 includes an actuator 20 coupled to one or more portions of shaft 14 at or near distal end 18 via one or more control members, such as steering wires (e.g., Bowden cables, not shown). Any suitable steering mechanism and/or actuators may be used. Upon manipulation of actuator 20, a medical professional may selectively deflect distal end 18 of shaft 14 in a first direction A or a second direction B along a deflection plane transverse to the longitudinal axis of handle 12. As shown, actuator 20 may be located along an enlarged proximal end of handle 12.").
In regards to claim 11, Chu discloses that the first engagement feature element and the second engagement feature element are each disposed proximate the living hinge ([0040]: "As noted in each of the arrangements of FIGS. 1-4, first portion 32 is fixedly coupled to shaft 14. That is, first portion 32 may be glued, welded, or otherwise fixedly coupled to (e.g., axially fixed and not moveable along the length of) shaft 14. In an alternative arrangement, as shown in FIG. 5, a first portion 132 of a force indicator 130 may be selectively coupleable and uncoupleable from shaft 14.").
In regards to claim 12, Chu discloses that the engagement feature comprises a first engagement feature element including a first jaw portion and a first handle portion, and a second engagement feature element including a second jaw portion and a second handle portion, the first jaw portion biased into contact with the second jaw portion ([0024]: "Any suitable steering mechanism and/or actuators may be used. Upon manipulation of actuator 20, a medical professional may selectively deflect distal end 18 of shaft 14 in a first direction A or a second direction B along a deflection plane transverse to the longitudinal axis of handle 12. As shown, actuator 20 may be located along an enlarged proximal end of handle 12. Such an enlargement may be useful to facilitate grasping of handle 12. For instance, when held upright, the enlarged proximal end of handle 12 may rest on a portion of the medical professional's hand so as to improve grasping of handle 12.").
In regards to claim 13, Chu discloses that the first jaw portion includes a first ramp portion, the second jaw portion includes a second ramp portion, and the first ramp portion and the second ramp portion together allow the engagement member to urge the first jaw portion and the second jaw portion away from their biased position such that the engagement member can be pushed into engagement with the engagement feature ([0040]: "As noted in each of the arrangements of FIGS. 1-4, first portion 32 is fixedly coupled to shaft 14. That is, first portion 32 may be glued, welded, or otherwise fixedly coupled to (e.g., axially fixed and not moveable along the length of) shaft 14. In an alternative arrangement, as shown in FIG. 5, a first portion 132 of a force indicator 130 may be selectively coupleable and uncoupleable from shaft 14.").
In regards to claim 14, Chu discloses that the assembly body includes a first side aperture and a second side aperture, the first handle portion extends out the first side aperture, the second handle portion extends out the second side aperture ([0007]: "A cap may have a stem threadably received within a first side of a lumen of the first portion. A compressible grommet may be positioned axially between the stem and a second side of the lumen of the first portion."), and the first handle portion and the second handle portion are adapted to be pushed in order to separate the first jaw portion and the second jaw portion ([0038]: "In such a manner, during insertion of shaft 14 into the body of a patient, the medical professional may grasp second grip portion 34A and push second grip portion 34A in the direction L, as shown in FIG. 3.").
In regards to claim 15, Chu discloses that the assembly further comprises a force gauge ([0027]: "As shown in FIG. 1, a force indicator 30 is coupled to shaft 14. Force indicator 30 may be arranged and/or positioned so as to measure at least one of the removal force imparted to the body of a patient during removal or withdrawal of shaft 14 from the body, or the insertion force imparted to the body of a patient during insertion of shaft 14 into or through body.").
In regards to claim 16, Chu discloses that the assembly body includes an ergonomic shape to facilitate being held in a person's hand ([0024]: "For example, handle 12 may have an ergonomic shape designed to be held comfortably in the hand, e.g., the palm of the hand of a medical professional.").
In regards to claim 17, Chu discloses an assembly for engaging a medical device shaft, comprising an assembly body defining a channel adapted to accommodate the medical device shaft extending therethrough, the assembly body adapted to be held in a person's hand ([0006]: "In one example, a device may include a first portion coupled to a shaft of an insertable medical device.", [0024]: "Handle 12 of insertion device 10 may have any shape suitable for gripping and controlling insertion device 10. For example, handle 12 may have an ergonomic shape designed to be held comfortably in the hand, e.g., the palm of the hand of a medical professional."), an engagement feature adapted to engage an engagement member secured on the medical device shaft ([0040]: "As noted in each of the arrangements of FIGS. 1-4, first portion 32 is fixedly coupled to shaft 14. That is, first portion 32 may be glued, welded, or otherwise fixedly coupled to (e.g., axially fixed and not moveable along the length of) shaft 14. In an alternative arrangement, as shown in FIG. 5, a first portion 132 of a force indicator 130 may be selectively coupleable and uncoupleable from shaft 14."), and a force gauge secured relative to the assembly body, the force gauge adapted to provide an indication of an applied force ([0027]: "As shown in FIG. 1, a force indicator 30 is coupled to shaft 14. Force indicator 30 may be arranged and/or positioned so as to measure at least one of the removal force imparted to the body of a patient during removal or withdrawal of shaft 14 from the body, or the insertion force imparted to the body of a patient during insertion of shaft 14 into or through body.").
In regards to claim 18, Chu discloses that the assembly body includes an ergonomic shape to facilitate being held in a person's hand ([0024]: "For example, handle 12 may have an ergonomic shape designed to be held comfortably in the hand, e.g., the palm of the hand of a medical professional.").
In regards to claim 19, Chu discloses that the engagement feature is adapted to releasably engage the engagement member ([0028]: "Additionally, force indicator 30 includes a second portion 34 moveable with respect to shaft 14 (e.g., not fixedly coupled to shaft 14, and is axially moveable along the length of shaft 14).").
In regards to claim 20, Chu discloses an assembly for engaging a medical device shaft, the medical device shaft including an engagement member, the assembly comprising an ergonomic assembly body defining a channel adapted to accommodate the medical device shaft extending therethrough, the ergonomic assembly body adapted to be held in a person's hand ([0006]: "In one example, a device may include a first portion coupled to a shaft of an insertable medical device.", [0024]: "Handle 12 of insertion device 10 may have any shape suitable for gripping and controlling insertion device 10. For example, handle 12 may have an ergonomic shape designed to be held comfortably in the hand, e.g., the palm of the hand of a medical professional.") and an engagement feature adapted to selectively engage an engagement member secured on the medical device shaft, where the engagement feature is movable between an open configuration in which the engagement feature does not engage the engagement member and a closed configuration in which the engagement feature engages the engagement member ([0040]: "As noted in each of the arrangements of FIGS. 1-4, first portion 32 is fixedly coupled to shaft 14. That is, first portion 32 may be glued, welded, or otherwise fixedly coupled to (e.g., axially fixed and not moveable along the length of) shaft 14. In an alternative arrangement, as shown in FIG. 5, a first portion 132 of a force indicator 130 may be selectively coupleable and uncoupleable from shaft 14.", [0028]: "Additionally, force indicator 30 includes a second portion 34 moveable with respect to shaft 14 (e.g., not fixedly coupled to shaft 14, and is axially moveable along the length of shaft 14).").
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.
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Chu in view of Korin (U.S. PGPub No. 2018/0311840).
In regards to claim 6, Chu discloses the invention substantially as described above in claim 1.
However, Chu does not disclose that the engagement feature further comprises a twist element that when rotated causes the spring-loaded collet to open.
Korin teaches a mechanism with an engagement feature comprising a twist element that when rotated causes the spring-loaded collet to open ([0046]: "...the structure of the locking piece 4 adopts the structural principle form similar to that of a spring collet, when the rotary twist part 411 of the cutter bar locking external clamp 41 is rotated with hands, the clamping jaws 413 of the external cone 412 are subjected to centering contraction, so as to fasten the tail end installation part 11 of the cutter bar, otherwise, the cutter bar 1 is loosened, thereby realizing rapid replacement of the cutter bar 1."). Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the thrombectomy apparatus to feature a twist element that when rotated causes a spring-loaded collet to open, as taught by Korin, as doing so would enable tactile user action to engage a portion of the device with rapid feedback and engagement of the device’s feature ([0046]: "...the structure of the locking piece 4 adopts the structural principle form similar to that of a spring collet, when the rotary twist part 411 of the cutter bar locking external clamp 41 is rotated with hands, the clamping jaws 413 of the external cone 412 are subjected to centering contraction, so as to fasten the tail end installation part 11 of the cutter bar, otherwise, the cutter bar 1 is loosened, thereby realizing rapid replacement of the cutter bar 1.").
In regards to claim 7, Chu discloses the invention substantially as described above in claim 5.
However, Chu does not disclose sliders disposed on either side of the assembly body that are operably coupled with the spring-loaded collet, where the sliders are adapted to allow manually opening the spring-loaded collet by sliding the sliders.
Korin teaches a mechanism with an engagement feature comprising sliders that interact with the collet ([0031]: "The end view shows a cap 500 slidably engaged with the housing or sleeve 400 of the safety knife 100. The end view also shows the collet 700 engaged with the shaft 600.". Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the thrombectomy apparatus to feature sliders disposed on either side of the assembly body that are operably coupled with the spring-loaded collet, as taught by Korin, as doing so would allow for the user to engage the collet through a familiar and common engagement action, such as sliding a component of a device that fits into a user’s hand ([0007]: "In most cases, the retraction of the blade into the knife body requires the user to operate a lever or slide mechanism in order to retract the blade.").
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRYAN M LEE whose telephone number is (703)756-1789. The examiner can normally be reached 9:00 am - 6:00 pm.
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/B.M.L./Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796
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