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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has complied with all conditions for receiving the benefit of an earlier filing date of 16 Feb 2024 under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c).
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01 Oct 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS has been considered by the Examiner.
Drawings
The drawings of 17 Feb 2025 and 05 May 2025, specifically photographic Fig. 1-4, are objected for failing to comply with 37 CFR 1.84(b)(1). Applicant is reminded that “Photographs, including photocopies of photographs, are not ordinarily permitted in utility and design patent applications”. See 37 CFR 1.84(b)(1).
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Claim Objections
Claims 2, 4, 17-18, and 20 are objected to because of the following informalities:
“to limit translation” should read “to limit a translation” (claim 2);
“to limit movement” should read “to limit a movement” (claim 4);
“to limit distal movement of the actuator while permitting proximal movement” should read “to limit a distal movement of the actuator while permitting a proximal movement” (claim 17);
“to mitigate radial translation” should read “to mitigate a radial translation” (claim 18); and
“wherein translation of the actuator” should read “wherein a translation of the actuator” (claim 20).
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation “a guide track extending along a length from a first track opening at a distal end of the guide track toward a proximal end of the housing”. It is unclear whether “a proximal end of the housing” recited in the limitation is the same or different from “a proximal end” of the housing also recited in line 2 of claim 1. Claims 2-13 inherit the deficiency by the nature of their dependency on claim 1. For purposes of the examination, the limitation is being given a broadest reasonable interpretation as “a guide track extending along a length from a first track opening at a distal end of the guide track toward the proximal end of the housing”.
Claim 2 recites the limitation “wherein the latch arm is configured to limit translation of the actuator along the length of the guide track”. The metes and bounds of the claim is unclear in view of this limitation. In particular, claim 1, to which claim 2 depends, already recites “a latch arm to lock a position of the actuator along the guide track”, thus the limitation “limiting translation of the actuator along the length of the guide track” in claim 2 does not appear to further limit “lock(ing) a position of the actuator along the guide track”. Claim 3 inherits the deficiency by the nature of their dependency on claim 2. For the purposes of the examination, the limitation in claim 2 is being given a broadest reasonable interpretation as “wherein the latch arm is configured to lock a translation of the actuator along the length of the guide track”.
Claim 4 recites the limitation “to limit movement of the actuator”. It is unclear whether this limitation is the same or different from “lock a position of the actuator along the guide track”. For purposes of the examination, the limitation is being given a broadest reasonable interpretation as “to lock the position of the actuator”.
Claim 8 recites the limitation “wherein when an obturator is coupled to the obturator coupler and a cannula is coupled to the cannula coupler, translation of the actuator towards the proximal end of the housing causes the obturator to be received within the cannula”. First, it is unclear whether “an obturator” recited in the limitation is the same or different from “an obturator” recited in claim 1, to which claim 8 depends. Second, it is unclear whether “a cannula” recited in the limitation is the same or different from “a cannula” recited in claim 1. Lastly, “translation of the actuator towards the proximal end of the housing causes the obturator to be received within the cannula” recites a method within the product claim of claim 8. See MPEP 2173.05(p).II. For purposes of the examination, the limitation is being given a broadest reasonable interpretation as “wherein the actuator is configured to translate towards the proximal end of the housing to receive the obturator within the cannula when the obturator is coupled to the obturator coupler and the cannula is coupled to the cannula coupler.”
Claim 10 recites the limitation “wherein the device is composed of a light-weight material”. The metes and bounds of “a light-weight material” are unclear since “a light weight” is relative. Since claim 11, which depends on claim 10, specifies the light-weight material recited in claim 10, a broadest reasonable interpretation is being given to “a light-weighted material” as a plastic.
Claim 13 recites the limitation “wherein the cannula coupler defines a washer having a washer slot configured to receive the proximal end of the cannula”. First, the metes and bounds of “the cannular coupler defines a washer having a washer slot configured to …”in the product claim of claim 13 are unclear. In particular, it is unclear whether the cannula coupler itself is a washer, the cannula coupler comprises a washer having a washer slot, the cannula coupler comprising an opening configured to receive the proximal end of the cannula, or otherwise. Second, the antecedent basis for “the proximal end of the cannula” is unclear: it is unclear whether “the proximal end of the cannula” should read “a proximal end of the cannula” or “the proximal end of housing” since claim 1, to which claim 13 depends recites “a proximal end” of the housing. For purposes of the examination, the limitation is being given a broadest reasonable interpretation as “wherein the cannula coupler comprising an opening configured to receive a proximal end of the cannula”.
Claim 14 recites the limitation “wherein in the closed position, the latch arm engages with the other of the housing or the actuator to limit axial movement of the actuator relative to the implantation axis, and wherein in the open position, the latch arm allows the actuator to translate along the guide track”. First, the limitation recites a method (i.e., “the latch arm engages” and “the latch arm allows”) within the product claim of claim 14. See MPEP 2173.05(p).II. Second, it is unclear whether “the other of the housing or the actuator” should read “the other one of the housing or the actuator” or otherwise. Claims 15-19 inherit the deficiency by the nature of their dependency on claim 14. For purposes of the examination, the limitation is being given a broadest reasonable interpretation as “wherein in the closed position, the latch arm is configured to engage with the other one of the housing or the actuator to limit axial movement of the actuator relative to the implantation axis, and wherein in the open position, the latch arm is configured to allow the actuator to translate along the guide track”.
Claim 16 recites the limitation “wherein the latch arm comprises arm teeth configured to engage with corresponding teeth on the other of the housing or the actuator”. It is unclear whether “the other of the housing or the actuator” should read “the other one of the housing or the actuator” or otherwise. For purposes of the examination, the limitation is being given a broadest reasonable interpretation as “wherein the latch arm comprises arm teeth configured to engage with corresponding teeth on the other one of the housing or the actuator”.
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.
Claims 14-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Clancy et al. (US PG Pub No. 2014/0243844) – hereinafter referred to as Clancy.
Regarding claim 14, Clancy discloses a device for implanting a medical device into a patient (at least Fig. 7A-D) comprising:
a housing (Fig. 7A-D: handle component 1750) having a proximal end (Fig. 7A-C: end of handle component 1750 through which stylet 1760 extends out) and a distal end (Fig. 7A-C: closed end of handle component 1750 opposing where stylet 1760 extends out);
an actuator (Fig. 7A-D: sliders 1770) slidably coupled to the housing and translatable along the housing parallel to an implantation axis (Fig. 7A-D and [0056]: sliders 1770 disposed longitudinally slidably in the lumen of handle member 1754 of handle component 1750);
a guide track (Fig. 7D: central longitudinal lumen, or track, within handle component 1750 along which rack 1762 moves) disposed on the housing and configured to receive and retain the actuator (Fig. 7D and [0057]: tooth-engagement portions 1770a of sliders 1770 extending into central longitudinal lumen of handle component 1750 in which rack 1762 comprising ratchet teeth 1763 resides),
wherein the guide track is shaped to limit radial movement and rotation of the actuator relative to the implantation axis (Fig. 7A-D: central longitudinal lumen within handle component 1750 extending longitudinally to limit any rotation of slides 1770); and
a latch arm (Fig. 7D: ratchet teeth 1763) coupled to one of the housing (Fig. 7D: handle component 1750) or the actuator (Fig. 7D: sliders 1770),
the latch arm (Fig. 7D: ratchet teeth 1763) being movable between a closed position and an open position (Fig. 7D and [0058]-[0059]: teeth 1763 reciprocally hinged, retracted, and/or depressed as open vs. closed positions),
wherein in the closed position, the latch arm engages with the other of the housing or the actuator to limit axial movement of the actuator relative to the implantation axis (Fig. 7B-D and [0059]: teeth 1763 biased to default position of not being hinged, retracted, and/or depressed into rack 1762 within handle component 1750 to limit engagement portions 1770a of sliders 1770 in between teeth 1763), and
wherein in the open position, the latch arm allows the actuator to translate along the guide track (Fig. 7D and [0059]: teeth 1763a hinged, retracted, and/or depressed into rack 1762 by engagement portions 1770a of sliders 1770 for a longitudinal translation of sliders 1770).
Regarding claim 15, Clancy discloses all limitations of claim 14, as discussed above, and Clancy further discloses:
wherein the guide track (Fig. 7D: central longitudinal lumen within handle component 1750 along which rack 1762 moves; [0059]: rack 1762 moves distally) comprises a pair of rails (Fig 7D: sides of handle member body 1754 between springs of sliders 1770 and teeth 1763 onto which “closed” teeth 1763 are contacting) extending parallel to the implantation axis (Fig. 7D: longitudinal axis of stylet 1760 and rack 1762) along a track side wall of the housing (Fig. 7D: side wall of handle component 1750, including aperture 1755).
Regarding claim 16, Clancy discloses all limitations of claim 14, as discussed above, and Clancy further discloses:
wherein the latch arm (Fig. 7D: ratchet teeth 1763) comprises arm teeth configured to engage with corresponding teeth on the other of the housing or the actuator (Fig. 7D: engagement portions 1770a of sliders 1770).
Regarding claim 17, Clancy discloses all limitations of claim 14, as discussed above, and Clancy further discloses:
wherein the latch arm (Fig. 7D: ratchet teeth 1763) is configured to limit distal movement of the actuator (Fig. 7D: sliders 1770) while permitting proximal movement of the actuator (Fig. 7D: sliders 1770) when in the closed position (Fig. 7D and [0059]: sliders 1770 provide a unidirectional distal movement of stylet 1760 in the direction of depressing teeth 1763 by engagement portions 1770a of sliders 1770).
Claims 14-15 and 17-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Selmon et al. (US PG Pub No. 2006/0276749) – hereinafter referred to as Selmon.
Regarding claim 14, Selmon discloses a device for implanting a medical device into a patient (at least Fig. 10A-B and [0091]: deploying cannula 1010 into a body) comprising:
a housing (Fig. 10A-B: handle body 1006) having a proximal end (Fig. 10A-B: end of handle body 1006 comprising an opening for extension of cannula 1010) and a distal end (Fig. 10A-B: other closed end of handle body 1006 opposing the extension of cannula 1010);
an actuator (Fig. 10A-B: actuator slide 1002) slidably coupled to the housing and translatable along the housing parallel to an implantation axis (Fig. 10A-B and [0091]: actuator slide 1002 sliding along handle body 1006 and parallel to cannula 1010 to deploy cannula 1010);
a guide track (Fig. 10A-B: linear slot of handle body 1006 in which slide 1002 translates) disposed on the housing and configured to receive and retain the actuator (Fig. 10A-B and [0091]: slide 1002 travels in a linear slot of handle body 1006 and attaches to cannula 1010),
wherein the guide track is shaped to limit radial movement and rotation of the actuator relative to the implantation axis (Fig. 10A-b and [0091]: slot is linear, thus limiting any radial movement and rotation of slide 1002 relative to extension of cannula 1010, and slide 1002 moves proximally and distally); and
a latch arm (Fig. 10A-B: lock 1004) coupled to one of the housing (Fig. 10A-B: handle body 1006) or the actuator (Fig. 10A-B: slide 1002),
the latch arm (Fig. 10A-B: lock 1004) being movable between a closed position and an open position, wherein in the closed position (Fig. 10A-B and [0091]: lock 1004 activates vs. deactivates by pivoting about pivot pin to trip vs. not trip distal end of lock 1004 into linear slot of handle body 1006),
wherein in the closed position (Fig. 10A), the latch arm (Fig. 10A: lock 1004) engages with the other of the housing or the actuator to limit axial movement of the actuator relative to the implantation axis (Fig. 10A and [0091]: spring-loaded 1008 lock mechanism 1004 is activated, automatically tripping the distal end of the lock 1004 into the distal end of the slot in the handle body 1006 through which the slide translates), and
wherein in the open position (Fig. 10B), the latch arm (Fig. 10B: lock 1004) allows the actuator to translate along the guide track (Fig. 10B and [0091]: lock 1004 is in unlocked configuration and depressing the proximal end of the lock 1004, which disengages the distal end of the lock 1004 from the slot in the handle body 1006 to allow translation along the linear slot of handle body 1006).
Regarding claim 15, Selmon discloses all limitations of claim 14, as discussed above, and Selmon further discloses:
wherein the guide track (Fig. 10A-B: linear slot of handle body 1006 in which slide 1002 translates) comprises a pair of rails (Fig. 10A-B: sides of linear slot of handle body 1006) extending parallel to the implantation axis (Fig. 10A-B: axis of cannula retraction and extraction) along a track sidewall of the housing (Fig. 10A-B: sidewall inside handle body 1006 opposing linear slot of handle body 1006 and slide 1002).
Regarding claim 18, Selmon discloses all limitations of claim 14, as discussed above, and Selmon further discloses:
wherein the guide track (Fig. 10A-B: linear slot of handle body 1006 in which slide 1002 translates) comprises a cap (Fig. 10A-B: sides of linear slot of handle body 1006 encasing cannula 1010) opposite a track sidewall (Fig. 10A-B: sidewall inside handle body 1006 opposing linear slot of handle body 1006 and slide 1002), the cap connecting a pair of rails (Fig. 10A-B: sides of linear slot of handle body 1006) and configured to mitigate radial translation of the actuator relative to the implantation axis (Fig. 10A-B and [0091]: slot of handle body 1006 in which slide 1002 translates is linear, thus mitigating any rotation of slide 1002).
Regarding claim 19, Selmon discloses all limitations of claim 14, as discussed above, and Selmon further discloses:
wherein the latch arm (Fig. 10A-B: lock 1004) is biased towards the closed position by a spring (Fig. 10A-B: spring 1008; [0091]: spring-loaded 1008 lock mechanism 1004 is activated, automatically tripping the distal end of the lock 1004 into the distal end of the slot in the handle body 1006 through which the slide translates).
Claim 20 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rue et al. (US PG Pub No. 2004/0199140) – hereinafter referred to as Rue.
Regarding claim 20, Rue discloses a device (at least Fig. 3) for implanting a medical device into a patient ([0024]: implanting device for subcutaneously inserting implantable objects) comprising:
a housing (Fig. 1-2: handle 220 and base 280) having a proximal end (Fig. 1-2: handle end 222) and a distal end (Fig. 1-2 and [0024]: base 280 is distal to handle end 222);
an obturator (Fig. 3-3a: post 244) removably coupled to the distal end of the housing (Fig. 3-3a and [0031]: post 244 is secured to the housing base 280 through post boss 246 inserted into post retainer recess 284);
an actuator (Fig. 3-3a: flexible actuator 260) slidably coupled to the housing and translatable along the housing parallel to an implantation axis (Fig. 3-3a and [0024]: movement of flexible actuator 260 in a direction toward cannula guide 340 and along track 300 away from handle 200; Fig. 5 and [0021]: button 262 of actuator 260 parallel to cannula 240 and in locked position),
a cannula (Fig. 3-3a: cannula 240) removably coupled to a distal end of the actuator (Fig. 3-3a: post rod 244; Fig. 1-2 and [0024]: in the retracted position, cannula 240 is drawn into the interior of base 280 and cannula is slid or moved with respect to post rod 244),
wherein the cannula (Fig. 3-3a: cannula 240) is configured to receive the obturator and the medical device ([0024]-[0025]: cannula 240 configured to slide or move with respect to post rod 244 an implantable object positioned within bore 242 of cannula 240), and
wherein translation of the actuator causes the cannula to slide over the obturator to release the medical device through a distal opening of the cannula (Fig. 1-2 and [0024]: in the retracted position, cannula 240 is drawn into the interior of base 280 and cannula is slid or moved with respect to post rod 244; [0025]: movement of actuator button 262 in a direction away from cannula guide 340 and towards handle 220 causes retraction of cannula 240 and release of an implantable object positioned within bore 242 of cannula 240).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3 are rejected under 35 U.S.C. 103 as being unpatentable over Rue in view of Selmon.
Regarding claim 1, Rue discloses a medical implantation device (at least Fig. 3) comprising:
a housing (Fig. 1-2: handle 220 and base 280), the housing extending from a proximal end (Fig. 1-2: handle end 222) to a distal end (Fig. 1-2 and [0024]: based 280 is distal to handle end 222);
an obturator coupler (Fig. 3-3a: post retainer recess 284) arranged at the distal end of the housing (Fig. 3-3a and [0041]: post retainer recess 284 at base 280) to couple an obturator (Fig. 3-3a: post 244) to the housing (Fig. 3-3a and [0031]: post 244 is secured to the housing base 280 through post boss 246 inserted into post retainer recess 284);
a guide track (Fig. 3-3A: angled track 300) extending along a length from a first track opening (Fig. 3-3a: opening between track 300 and guide ramp 350) at a distal end of the guide track toward a proximal end of the housing (Fig. 3-3a and [0029]: actuator guide posts 264, 266 move parallel to the angled guide ramp 350, translating movement of actuator 260 along angled track 300);
an actuator (Fig. 3-3a: flexible actuator 260) to be received within the guide track such that the actuator is translatable along the length of the guide track (Fig. 3-3a and [0024]: movement of flexible actuator 260 in a direction toward cannula guide 340 and along track 300 away from handle 200),
the actuator including a cannula coupler (Fig. 3-3a: boss channel 272) arranged at a distal end of the actuator (Fig. 3-3a: actuator 260) to couple a cannula (Fig. 3-3a: cannula 240) to the actuator (Fig. 3-3a and [0028]: movement of flexible actuator 260 pulls the cannula 240 toward the post retainer recess 284).
Rue does not disclose:
a latch arm to lock a position of the actuator along the guide track.
Selmon in the same field of slidably actuating a cannula, however, teaches:
a latch arm (Fig. 10A-B: lock 1004) to lock a position of an actuator (Fig. 10A-B: slide 1002) along a guide track (Fig. 10A-B: slot in handle body 1006 through which slide 1002 slides; [0091]: Upon full retraction of the slide 1002, the spring-loaded 1008 lock mechanism 1004 is activated, automatically tripping the distal end of the lock 1004 into the distal end of the slot in the handle body 1006 through which the slide translates).
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 Rue to include Selmon’s latch arm. One of ordinary skill in the art would have combined the elements as claimed by known methods (i.e., adding a lock to the actuator, as disclosed by Selmon), and the combination would have yielded a reasonable expectation of success since both Rue and Selmon are directed to a cannula comprising a sliding actuator. The motivation for the combination would have been “Use of this locking mechanism 1004 prevents the working element 1010 from inadvertent deployment (of the cannula)”, as taught by Selmon ([0091]).
Regarding claim 2, Rue in view of Selmon discloses all limitations of claim 1, as discussed above, and Selmon further teaches (also see claim 1 above):
wherein the latch arm (Fig. 10A-B: lock 1004) is configured to limit translation of the actuator (Fig. 10A-B: slide 1002) along the length of the guide track (Fig. 10A-B: slot in handle body 1006 through which slide 1002 slides; [0091]: Upon full retraction of the slide 1002, the spring-loaded 1008 lock mechanism 1004 is activated, automatically tripping the distal end of the lock 1004 into the distal end of the slot in the handle body 1006 through which the slide translates).
Regarding claim 3, Rue in view of Selmon discloses all limitaitons of claim 2, as discussed above, and Selmon further teaches (also see claims 1-2 above):
wherein the latch arm (Fig. 10A-B: lock 1004) is rotatable abound a hinge (Fig. 10A-B: pivot pin) between a closed position (Fig. 10A: locked configuration in which look 1004 is activated) and an open position (Fig. 10B: unlocked configuration in which lock 1004 is not activated) to selectively permit the actuator (Fig. 10A-B: slide 1002) be axially translated relative to the length of the guide track (Fig. 10A-B and [0091]: Upon full retraction of slide 1002, the spring-loaded 1008 lock mechanism 1004 is activated, automatically tripping the distal end of the lock 1004 into the distal end of the slot in the handle body 1006 through which the slide translates, and subsequent distal advancement of slide 1002 is possible upon depressing the proximal end of lock 1004, or pivoting about pivot pin, which disengages the distal end of lock 1004 from the slot in handle body 1006).
Claims 1-2 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Rue in view of Adams et al. (US Patent No. 5325848) – hereinafter referred to as Adams.
Regarding claim 1, Rue discloses a medical implantation device (at least Fig. 3) comprising:
a housing (Fig. 1-2: handle 220 and base 280), the housing extending from a proximal end (Fig. 1-2: handle end 222) to a distal end (Fig. 1-2 and [0024]: based 280 is distal to handle end 222);
an obturator coupler (Fig. 3-3a: post retainer recess 284) arranged at the distal end of the housing (Fig. 3-3a and [0041]: post retainer recess 284 at base 280) to couple an obturator (Fig. 3-3a: post 244) to the housing (Fig. 3-3a and [0031]: post 244 is secured to the housing base 280 through post boss 246 inserted into post retainer recess 284);
a guide track (Fig. 3-3A: angled track 300) extending along a length from a first track opening (Fig. 3-3a: opening between track 300 and guide ramp 350) at a distal end of the guide track toward a proximal end of the housing (Fig. 3-3a and [0029]: actuator guide posts 264, 266 move parallel to the angled guide ramp 350, translating movement of actuator 260 along angled track 300);
an actuator (Fig. 3-3a: flexible actuator 260) to be received within the guide track such that the actuator is translatable along the length of the guide track (Fig. 3-3a and [0024]: movement of flexible actuator 260 in a direction toward cannula guide 340 and along track 300 away from handle 200),
the actuator including a cannula coupler (Fig. 3-3a: boss channel 272) arranged at a distal end of the actuator (Fig. 3-3a: actuator 260) to couple a cannula (Fig. 3-3a: cannula 240) to the actuator (Fig. 3-3a and [0028]: movement of flexible actuator 260 pulls the cannula 240 toward the post retainer recess 284).
Rue does not disclose:
a latch arm to lock a position of the actuator along the guide track.
Adams in the same field of slidably actuating a cannula, however, teaches:
a latch arm (Fig. 4: ratchets 90) to lock a position of a slidable actuator (Fig. 4: actuator slide 100) along a guide track (Fig. 4: slot 90; Col 7, lines 58-68: ratchet 90 extend longitudinally along opposite sides of slot 62 and pawls 109 of actuator slide 100 and ratchets 90 provide a ratchet mechanism).
It is noted that Adams’s ratchets 90 lock the position of actuator slide 100 by “pawls 109 (of actuator slide 100) which are normally biased by the resilient hinge 107 into engagement with a ratchet 90 formed inside of each of the handle sections 63 and 64 to retain the actuator slide 100 in a selected position on the handle assembly 60” (Col 7, lines 59-63 of Adams), fixing the actuator slide 100 in between the ratchets.
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 Rue to include Adams’s latch arm. One of ordinary skill in the art would have combined the elements as claimed by known methods (i.e., adding ratchet mechanism between the actuator and the guide track, as disclosed by Adams), and the combination would have yielded a reasonable expectation of success since both Rue and Adams are directed to a cannula comprising a sliding actuator. The motivation for the combination would have been “to retain the actuator slide 100 in a selected position on the handle assembly 60”, as disclosed by Adams (Col, lines 59-63), for a controlled translation of the actuator.
Regarding claim 2, Rue in view of Adams discloses all limitations of claim 1, as discussed above, and Adams further teaches (also see claim 1 above):
wherein the latch arm (Fig. 4: ratchets 90) is configured to limit translation of the actuator (Fig. 4: actuator slide 100) along the length of the guide track (Fig. 4: slot 62; Col 7, lines 58-68: pawls 109 of actuator slide 100 and ratchets 90 provide a ratchet mechanism to retain the actuator slide 100 in a selected position).
Regarding claim 4, Rue in view of Adams discloses all limitations of claim 1, as discussed above, and Adams further teaches (also see claim 1 above):
wherein the actuator (Fig. 4: actuator slide 100) includes a first set of teeth (Fig. 4: pawls 109) and the latch arm (Fig. 4: ratchets 90) includes a second set of teeth configured to mate with the first set of teeth to limit movement of the actuator (Col 7, lines 58-68: pawls 109 of actuator slide 100 and ratchets 90 provide a ratchet mechanism to retain the actuator slide 100 in a selected position).
Claims 5-13 are rejected under 35 U.S.C. 103 as being unpatentable over Rue in view of Selmon or Adams.
Regarding claim 5, Rue in view of Selmon or Adams discloses all limitations of claim 1, as discussed above, and Rue further discloses:
wherein the guide track (Fig. 3-3a: track 300) is shaped to limit rotation of the actuator (Fig. 3-3a and [0028]: angled track 300 for translation of actuator 260).
Regarding claim 6, Rue in view of Selmon or Adams discloses all limitations of claim 1, as discussed above, and Rue further discloses:
wherein the guide track (Fig. 3-3a: track 300) is integrally formed in the housing (Fig. 3-3a: track 300 integrally formed in base 280).
Regarding claim 7, Rue in view of Selmon or Adams discloses all limitations of claim 1, as discussed above, and Rue further discloses:
wherein the obturator coupler (Fig. 3-3a: post retainer recess 284) is coaxial with the cannula coupler (Fig. 3-3a: boss channel 272; Fig. 4-5).
Regarding claim 8, Rue in view of Selmon or Adams discloses all limitations of claim 7, as discussed above, and Rue further discloses:
wherein when an obturator (Fig. 3-3a: post 244 including post boss end 246) is coupled to the obturator coupler (Fig. 3-3a: post retainer recess 284; [0041]: recess 284 secures post boss end 246) and a cannula (Fig. 3-3a: cannula 240) is coupled to the cannula coupler (Fig. 3-3a: boss channel 272; [0028]: boss channel 272 receives guide posts 362, 364 of cannula 240), translation of the actuator towards the proximal end of the housing causes the obturator to be received within the cannula (Fig. 1-2 and [0024]: in the retracted position, cannula 240 is drawn into the interior of base 280 and cannula is slid or moved with respect to post rod 244; [0025]: movement of actuator button 262 in a direction away from cannula guide 340 and towards handle 220 causes retraction of cannula 240 and release of an implantable object).
Regarding claim 9, Rue in view of Selmon or Adams discloses all limitations of claim 1, as discussed above, and Rue further discloses:
wherein the obturator coupler (Fig. 3-3a: post retainer recess 284) is integrally formed within the housing (Fig. 3-3a and [0041]: recess 284 formed on interior surface of the implanter base halves 280a, 280b).
Regarding claims 10-11, Rue in view of Selmon or Adams discloses all limitations of claim 1, as discussed above, and Rue further discloses:
wherein the device is composed of a light-weight material ([0034]: implanting device molded from plastics); and
wherein the light-weight material comprises a plastic ([0034]: implanting device molded from plastics).
Regarding claim 12, Rue in view of Selmon or Adams discloses all limitations of claim 1, as discussed above, and Rue further discloses:
wherein the device is sterilizable and reusable ([0040]: implanting device formed of autoclavable material for sterilization and reuse).
Regarding claim 13, Rue in view of Selmon or Adams discloses all limitations of claim 1, as discussed above, and Rue further discloses:
wherein the cannula coupler defines a washer having a washer slot (Fig. 3-3a: U-shaped boss channel 272) configured to receive the proximal end of the cannula (Fig. 3-3a and [0028]: boss channel 272 engages the cannula boss guide posts 362 and 364 and permits a pulling or pushing force to be exerted on the cannula 240).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Ducharme et al. (WIPO Pub No. 2011/075380) discloses a latch arm configured to lock a position of the actuator along a track and limit a translation of the actuator along a length of the track (at least Fig. 19D: pawl 1971 of translatable member 1970 locked in position by dent structure 1921 and translation of member 1970 is limited to translating between the dent structures 1921);
Khamis et al. (US PG Pub No. 2010/0274074) discloses a latch arm that is rotatable about a hinge between a closed position and an open position to selectively permit a translation relative to the length of the track (at least Fig. 2A-B: lever 60 in closed v. open positions for translation of sheath 46);
Lightman et al. (US Patent No. 5810828) discloses a latch arm configured to transition between a closed position and an open position (at least latch 12), but does not disclose at least an actuator configured to translate along a guide track;
Drubetsky et al. (US PG Pub No. 20110004121) discloses a latch arm configured to limit an insertion depth of a cannula (at least Fig. 7: throw depth step 164), but the latch arm is not configured to lock a position of an actuator along a guide track (at least Fig. 7 and [0040]: throw depth stop 164 is not coupled to actuator button 110 in controlling the insertion depth); and
Chu (US PG Pub No. 20060058569) discloses an actuator having a set of teeth to control a cannula translation (Fig. 1-2 and [0023]-[0024]: index wheel 19 comprising teeth 13 to control the translation of a cannula), but does not disclose the actuator being at least translatable and a latch arm configured to lock the position of the actuator along a guide track.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Younhee Choi whose telephone number is (571)272-7013. The examiner can normally be reached M-F 9AM-5PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anhtuan Nguyen can be reached at 571-272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Y.C./Examiner, Art Unit 3797
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
2/26/26