DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
This office action is responsive to the amendment filed on 06/09/2026. As directed by the amendment: claims 20 have been amended, claims 2-18 have been cancelled and claims 21-37 have been added. Thus, claims 20-37 are presently pending in this application.
Election/Restrictions
Applicant's election with traverse of Group 1, species B (Fig. 3C), a single follower that extends within the channel, and Group 2, species A (Fig. 4) a lug with a smaller lug arc in the reply filed on 04/09/2026 is acknowledged. The traversal is on the ground(s) that the examiner has not provided support of the state rationale for the need for election, that the examiner did not offer any support for the assertion that followers with different axial lengths and/or lugs with smaller or larger lug arcs have acquired a separate status in the art due to their recognized divergent subject matter, and that the inventions in these groups require a different field of search.
This is not found persuasive because the species will require different text searching, such in group 1, species A would require text searching with terms such as “independently” which would not be required by species B, because species A has three individual followers that can rotate independently, whereas species B has one longer follower that rotates as one unit, and as such are mutually exclusive structures.
For group 2, the species would require separate text search such as with terms such as “12 degrees” would be applicable to species A but not to species B.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1 and 19 withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on06/09/2026.
Claims 36-37 are additionally withdrawn as they read on Group 1, species A and species C, and not elected species B.
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 23-24 and 29-35 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.
Where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). The term “yoke” in claims 23, 29, and 32 is used by the claim to mean “an outer periphery,” while the accepted meaning is “a clamp or similar piece that embraces two parts to hold or unite them in position” per the online Merriam-Webster dictionary. The term is indefinite because the specification does not clearly redefine the term. Appropriate correction is required.
Where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). The term “apron” in claims 23, 29, and 32 is used by the claim to mean “a cover,” while the accepted meaning is “something that suggests or resembles an apron in shape, position, or use: such as the lower member under the sill of the interior casing of a window” per the online Merriam-Webster dictionary. The term is indefinite because the specification does not clearly redefine the term. Appropriate correction is required.
Claims 24, 30-31, and 33-35 are rejected as being dependent on claims 23, 29, and 32 respectively.
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.
Claim(s) 20-22 and 25-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vad et al (US 20160338864 A1), herein referenced to as “Vad” in view of Lim et al (US 20160199206 A1), herein referenced to as “Lim”, and Damm et al (US 20150148894 A1), herein referenced to as “Damm”.
Claim 20
Vad discloses: A delivery device 2 (see Figs. 1-16, [0062]) for delivering an implantable medical device (see [0062], prosthesis) into a body lumen of a patient, the delivery device 2 comprising: a handle assembly 8 (see Figs. 1-15, [0062]) having a lengthwise axis the longitudinal axis of 8 and comprising: a proximal handle portion 12 (see Figs. 1-15, [0062]); a distal handle portion 10 (see Figs. 1-15, [0062]) having a distal handle body 10 (see Figs. 1-15, [0062] 10 extends distally towards 14) defining a circular cross- sectional shape 10 has a circular cross-sectional shape (see Figs. 1-15), a circumferential channel the channel which 142 is located within (see Figs. 13 and 15, [0081], within 12), and a first circumferential wall 154 (see Figs. 13-15, [0085]); a follower 146 (see Figs. 13-16, [0081], is a follower as it engages with 140 to rotate and be operatively connected) disposed in the circumferential channel the channel which 142 is located within and rotatable (see Figs. 1-16, [0081]-[0083] 142 + 146 is rotatable about 10 which extends through 12) about the distal handle body 10, the follower 146 defining a cantilever portion 146 is a cantilever portion being a longitudinally extend bar (see Figs. 13 and 15); and an actuator 140 (see Figs. 12-16, [0081]-[0083]) disposed over the follower 146 and rotatable (see [0081]-[0084], 12 + 140 can be rotated over 10) about the distal handle body 10, the actuator 140 defining a follower driver 158 + 144 + one or more structures (see Figs. 12-15, [0081]-[0085], 144 engages with 146/142 and 158 engages with 142, and 158 extends radially inwardly) extending radially inward toward the distal handle body 10 and configured to contact the follower 146 such that rotation of the actuator 140 drives rotation (see [0081]-[0085], rotation of 140 causes rotation of 146/142) of the follower 146; an inner elongate member 22 (see Figs. 1-9, [0075]) extending from the handle assembly 8; and a sheath 104 (see Figs. 1-9,[ 0075]) disposed over the inner elongate member 22.
Vad does not explicitly disclose: the proximal handle portion defining a rounded triangular cross-sectional shape; the first circumferential wall defining a hard stop adjacent the circumferential channel; the cantilever portion extending axially over the first circumferential wall and configured to contact the hard stop.
However, Lim in a similar field of invention teaches a delivery device 100 (see Figs. 1-15) for delivering an implantable medical device implant (see [0107]) with a proximal handle portion 9 (see Figs. 1-15) with a follower 195 (see Figs. 12-15) with a cantilever portion the extension of 195 that contacts 241 (see Fig. 14), an actuator 91 (see Figs. 1-15), a circumferential channel the channel in which 195 and 241 interact (see Fig. 14) and a circumferential wall the wall which 241 is on (see Figs. 13-15). Lim further teaches: the first circumferential wall the wall which 241 is on (see Figs. 13-15) defining a hard stop 241 adjacent the circumferential channel the channel in which 195 and 241 interact (see Fig. 14); the cantilever portion the extension of 195 that contacts 241 extending axially over the first circumferential wall the wall which 241 is on (see Fig. 14, axially, the circumferential wall that 241 is on overlaps with that of 195) and configured to contact the hard stop 241 (see Fig 14, [0166]-[0167], 195 contacts 241).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Vad to incorporate the teachings of Lim and teach a delivery device for delivering an implantable medical device with the first circumferential wall defining a hard stop adjacent the circumferential channel; the cantilever portion extending axially over the first circumferential wall and configured to contact the hard stop. Motivation for such can be found in Lim as this limits the amount of rotation of the actuator (see [0169]) which prevents the implant from overly unfolded during implantation from the pre-set value of rotation, which prevents the stent from bouncing up and down in the blood flow of the beating heart which makes positioning difficult (see [0081]).
The combination of Vad and Lim does not explicitly teach: the proximal handle portion defining a rounded triangular cross-sectional shape.
However, Damm in a similar field of invention teaches a delivery device 10-1 + 10-2 (see Fig. 8) for an implantable medical device 80-1 (see Figs. 6A-6F) with a proximal handle portion 11 (see Fig. 8) and a distal handle portion 12 (see Fig. 8). Damm further teaches: the proximal handle portion 11 defining a rounded triangular cross-sectional shape (see Fig. 8, 11 takes upon a rounded triangular cross-sectional shape).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the rounded circular cross-sectional shaped proximal handle portion of Vad to incorporate the teachings of Damm and teach a delivery device with the proximal handle portion defining a rounded triangular cross-sectional shape. Motivation for such can be found in Damm as this forms a “jacket-like” hand grip (see [0249]) which provides a grip for a user, which provides a more ergonomic grip and allow the user to differentiate what part of the handle they are holding.
Claim 21
The combination of Vad, Lim, and Damm teaches: The delivery device of claim 20, see 103 rejection above. Vad further discloses: wherein the follower 146 comprises a body 142 (see Figs. 15-16, [0082]) that terminates (see Fig. 16, 142 terminates at 150) in circumferentially spaced-apart first and second ends (see annotated Fig. 16 below, [0082]).
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Claim 22
The combination of Vad, Lim, and Damm teaches: The delivery device of claim 21, see 103 rejection above. Vad further discloses: wherein the first and second ends (see annotated Fig. 16 below claim 21) are resiliently displaceable (see [0082], 142 which 150 is part of is made a resilient material, see [0083], and is capable of moving between a first state and a second radially inwardly compressed state, so the first and second ends of 150 are resiliently displaceable) from each other.
Claim 25
The combination of Vad, Lim, and Damm teaches: The delivery device of claim 20, see 103 rejection above. Vad further discloses: wherein the handle assembly 8 further comprises a transition portion 220 (see Figs. 1-15, [0104]) axially disposed between the proximal handle portion 12 (see Figs. 1-15, 220 is between 12 and the distal portion of 10, away from the implant) and the distal handle portion 10.
Claim 26
The combination of Vad, Lim, and Damm teaches: The delivery device of claim 25, see 103 rejection above. Vad further discloses: wherein the distal handle portion 10 has a first outer diameter (see annotated Fig. 1 below) ; and wherein the transition portion 220 has a second outer diameter (see annotated Fig. 1 below) that is different than the first outer diameter (see annotated Fig. 1 below, the second outer diameter is less than the first outer diameter).
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Claim 27
The combination of Vad, Lim, and Damm teaches: The delivery device of claim 26, see 103 rejection above. Vad further discloses: wherein the second outer diameter is less than the first outer diameter (see annotated Fig. 1 below claim 26).
Claim(s) 23-24, 29-31, and 32-35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vad, Lim, and Damm as applied to claims 20 and 26 respectively above, and further in view of Gray et al (US 20150305863 A1), herein referenced to as “Gray”.
Claim 23
The combination of Vad, Lim, and Damm teaches: The delivery device of claim 20, see 103 rejection above. Vad further discloses: wherein the proximal handle portion 12 comprises a yoke the opening of 140 opposite from 148 (see Fig. 12, see 112(b) rejection above, interpreted an outer periphery, is an outer periphery) defining a proximal handle portion proximal end the proximal end of 140 opposite from 148 and an opening the opening of the proximal end of 140 opposite from 148 (see Fig. 12); and wherein the inner elongate member 22 and sheath 104 (see Fig. 9, extends through the opening of the proximal end of 140 opposite from 148) extend through the opening the opening of the proximal end of 140 opposite from 148.
The combination of Vad, Lim, and Damm does not explicitly teach: an apron extending to the opening.
However, Gray in a similar field of invention teaches a delivery device 10 (see Figs. 1-6) with a proximal handle portion 34 (see Figs. 1-6) with a yoke the proximal end periphery of 34 opposite from 44 that extends into 42 (see Figs. 1-6) and an opening 46 (see Figs. 1-6). Gray further teaches: an apron 42 (see Figs. 1-6, [0044] extending to the opening 46 (see Figs. 1-6, 42 extends radially inwardly towards 46).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the proximal handle portion of Vad to incorporate the teachings of Gray and teach a delivery device with an apron extending to the opening. Motivation for such can be found in Gray as this seal can function as a hemostatic seal to a delivery device to prevent blood from entering into the delivery device (see [0009]).
Claim 29
The combination of Vad, Lim, and Damm teaches: The delivery device of claim 26, see 103 rejection above. Vad further discloses: wherein the proximal handle portion 12 comprises a yoke the opening of 140 opposite from 148 (see Fig. 12, see 112(b) rejection above, interpreted an outer periphery, is an outer periphery) defining a proximal handle portion proximal end the proximal end of 140 opposite from 148 and an opening the opening of the proximal end of 140 opposite from 148 (see Fig. 12).
The combination of Vad, Lim, and Damm does not explicitly teach: an apron extending to the opening.
However, Gray in a similar field of invention teaches a delivery device 10 (see Figs. 1-6) with a proximal handle portion 34 (see Figs. 1-6) with a yoke the proximal end periphery of 34 opposite from 44 that extends into 42 (see Figs. 1-6) and an opening 46 (see Figs. 1-6). Gray further teaches: an apron 42 (see Figs. 1-6, [0044] extending to the opening 46 (see Figs. 1-6, 42 extends radially inwardly towards 46).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the proximal handle portion of Vad to incorporate the teachings of Gray and teach a delivery device with an apron extending to the opening. Motivation for such can be found in Gray as this seal can function as a hemostatic seal to a delivery device to prevent blood from entering into the delivery device (see [0009]).
Claim 30
The combination of Vad, Lim, Damm, and Gray teaches: The delivery device of claim 29, see 103 rejection above. Vad further discloses: wherein the inner elongate member 22 and sheath 104 (see Fig. 9, extends through the opening of the proximal end of 140 opposite from 148) extend through the opening the opening of the proximal end of 140 opposite from 148.
Claim 32
The combination of Vad, Lim, and Damm teaches: The delivery device of claim 26, see 103 rejection above. Vad further discloses: wherein the proximal handle portion 12 comprises a yoke the opening of 140 opposite from 148 (see Fig. 12, see 112(b) rejection above, interpreted an outer periphery, is an outer periphery) defining a proximal handle portion proximal end the proximal end of 140 opposite from 148 and an opening the opening of the proximal end of 140 opposite from 148 (see Fig. 12).
The combination of Vad, Lim, and Damm does not explicitly teach: an apron extending to the opening.
However, Gray in a similar field of invention teaches a delivery device 10 (see Figs. 1-6) with a proximal handle portion 34 (see Figs. 1-6) with a yoke the proximal end periphery of 34 opposite from 44 that extends into 42 (see Figs. 1-6) and an opening 46 (see Figs. 1-6). Gray further teaches: an apron 42 (see Figs. 1-6, [0044] extending to the opening 46 (see Figs. 1-6, 42 extends radially inwardly towards 46).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the proximal handle portion of Vad to incorporate the teachings of Gray and teach a delivery device with an apron extending to the opening. Motivation for such can be found in Gray as this seal can function as a hemostatic seal to a delivery device to prevent blood from entering into the delivery device (see [0009]).
Claim(s) 24, 31, and 33-35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vad, Lim, Damm, and Gray as applied to claims 23, 30, and 32 respectively above, and further in view of Trapeznikov (US 20230200971 A1), herein referenced to as “Trapeznikov”.
Claim 24
The combination of Vad, Lim, Damm, and Gray teaches: The delivery device of claim 23, see 103 rejection above. The combination of Vad, Lim, Damm, and Gray does not explicitly teach: wherein the proximal handle portion proximal end lies on a plane disposed at a non-orthogonal angle to the lengthwise axis of the handle assembly.
However, Trapeznikov in a similar field of invention teaches a delivery device 1 (see Figs. 1-10) for a medical implant coronary stent (see [0001]) with a handle assembly 1 + 14 + 13 (see Figs. 1-10) with a proximal handle portion 1 (see Figs. 1-10) with a proximal handle portion proximal end 5 (see Figs. 1-10) and a lengthwise axis (see annotated Fig. 3 below). Trapeznikov further teaches: wherein the proximal handle portion proximal end 5 lies on a plane (see annotated Fig. 3 below) disposed at a non-orthogonal angle to the lengthwise axis (see annotated Fig. 3 below) of the handle assembly.
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It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Vad to incorporate the teachings of Trapeznikov and teach a delivery device with the proximal handle portion proximal end lies on a plane disposed at a non-orthogonal angle to the lengthwise axis of the handle assembly. Motivation for such can be found in Trapeznikov as this shape is adapted to be held by a surgeon’s hand and serve as a pad to fix a coronary catheter (see [0024]).
Claim 31
The combination of Vad, Lim, Damm, and Gray teaches: The delivery device of claim 30, see 103 rejection above. The combination of Vad, Lim, Damm, and Gray does not explicitly teach: wherein the proximal handle portion proximal end lies on a plane disposed at a non-orthogonal angle to the lengthwise axis of the handle assembly.
However, Trapeznikov in a similar field of invention teaches a delivery device 1 (see Figs. 1-10) for a medical implant coronary stent (see [0001]) with a handle assembly 1 + 14 + 13 (see Figs. 1-10) with a proximal handle portion 1 (see Figs. 1-10) with a proximal handle portion proximal end 5 (see Figs. 1-10) and a lengthwise axis (see annotated Fig. 3 below). Trapeznikov further teaches: wherein the proximal handle portion proximal end 5 lies on a plane (see annotated Fig. 3 below) disposed at a non-orthogonal angle to the lengthwise axis (see annotated Fig. 3 below) of the handle assembly.
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It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Vad to incorporate the teachings of Trapeznikov and teach a delivery device with the proximal handle portion proximal end lies on a plane disposed at a non-orthogonal angle to the lengthwise axis of the handle assembly. Motivation for such can be found in Trapeznikov as this shape is adapted to be held by a surgeon’s hand and serve as a pad to fix a coronary catheter (see [0024]).
Claim 33
The combination of Vad, Lim, Damm, and Gray teaches: The delivery device of claim 32, see 103 rejection above. The combination of Vad, Lim, Damm, and Gray does not explicitly teach: wherein the proximal handle portion proximal end lies on a plane disposed at a non-orthogonal angle to the lengthwise axis of the handle assembly.
However, Trapeznikov in a similar field of invention teaches a delivery device 1 (see Figs. 1-10) for a medical implant coronary stent (see [0001]) with a handle assembly 1 + 14 + 13 (see Figs. 1-10) with a proximal handle portion 1 (see Figs. 1-10) with a proximal handle portion proximal end 5 (see Figs. 1-10) and a lengthwise axis (see annotated Fig. 3 below). Trapeznikov further teaches: wherein the proximal handle portion proximal end 5 lies on a plane (see annotated Fig. 3 below) disposed at a non-orthogonal angle to the lengthwise axis (see annotated Fig. 3 below) of the handle assembly.
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It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Vad to incorporate the teachings of Trapeznikov and teach a delivery device with the proximal handle portion proximal end lies on a plane disposed at a non-orthogonal angle to the lengthwise axis of the handle assembly. Motivation for such can be found in Trapeznikov as this shape is adapted to be held by a surgeon’s hand and serve as a pad to fix a coronary catheter (see [0024]).
Claim 34
The combination of Vad, Lim, Damm, Gray, and Trapeznikov teaches: The delivery device of claim 33, see 103 rejection above. Vad further discloses: wherein the follower 146 comprises a body 142 (see Figs. 15-16, [0082]) that terminates (see Fig. 16, 142 terminates at 150) in circumferentially spaced-apart first and second ends (see annotated Fig. 16 below, [0082]).
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Claim 35
The combination of Vad, Lim, Damm, Gray, and Trapeznikov teaches: The delivery device of claim 34, see 103 rejection above. Vad further discloses: wherein the first and second ends (see annotated Fig. 16 below claim 34) are resiliently displaceable (see [0082], 142 which 150 is part of is made a resilient material, see [0083], and is capable of moving between a first state and a second radially inwardly compressed state, so the first and second ends of 150 are resiliently displaceable) from each other.
Allowable Subject Matter
Claim 28 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: the prior art of record fails to teach or render obvious a delivery device for delivering an implantable medical device into a body lumen of a patient comprising, inter alia, a handle assembly having a lengthwise axis comprising: a proximal handle portion defining a rounded triangular cross-sectional shape; a distal handle portion having a distal handle body defining a circular cross- sectional shape, a circumferential channel, and a first circumferential wall defining a hard stop adjacent the circumferential channel; a follower disposed in the circumferential channel and rotatable about the distal handle body; wherein the handle assembly further comprises a transition portion axially disposed between the proximal handle portion and the distal handle portion, wherein the distal handle portion has a first outer diameter; and wherein the transition portion has a second outer diameter that is different than the first outer diameter; wherein the second outer diameter is less than the first outer diameter, and wherein the proximal handle portion has a side length equal to the length of one side of the triangular cross-sectional shape of the proximal handle portion; and wherein the second outer diameter is less than the side length. Vad et al (US 20160338864 A1) teaches a delivery device for delivering an implantable medical device into a body lumen of a patient with a handle assembly with a proximal handle portion and a distal handle portion, but does not teach the handle portion defining a rounded triangular cross-sectional shape, and when modified to have a rounded triangular cross-sectional shape, the diameter of the proximal handle portion is equal to the second outer diameter of the transition portion or greater at other portions, not less than. Lim et al (US 20160199206 A1) teaches a delivery device for delivering an implantable medical device into a body lumen of a patient with a handle assembly with a proximal handle portion and a distal handle portion with a transition portion in between the two, but does not teach the proximal handle portion having a rounded triangular cross-sectional shape. Damm et al (US 20150148894 A1) teaches a delivery device for delivering an implantable medical device into a body lumen of a patient with a handle assembly with a proximal handle portion and a distal handle portion and the proximal handle portion has a rounded triangular cross-sectional shape, however does not teach a transition portion in between the proximal handle portion and the distal handle portion. Gray et al (US 20150305863 A1) teaches a delivery device for delivering an implantable medical device into a body lumen of a patient with a handle assembly with a proximal handle portion and a distal handle portion with a transition portion in between the two, but does not teach the proximal handle portion having a rounded triangular cross-sectional shape. Trapeznikov (US 20230200971 A1) teaches a delivery device for delivering an implantable medical device into a body lumen of a patient with a handle assembly with a proximal handle portion and a distal handle portion with a transition portion in between the two, but does not teach the proximal handle portion having a rounded triangular cross-sectional shape. Crisostomo et al (US 20130144276 A1) teaches a delivery device for delivering an implantable medical device into a body lumen of a patient with a handle assembly with a proximal handle portion and a distal handle portion with a transition portion in between the two, however does not teach wherein the proximal handle portion has a side length equal to the length of one side of the triangular cross-sectional shape of the proximal handle portion; and wherein the second outer diameter is less than the side length. Furthermore, in regards to Crisostomo one of ordinary skill in the art would not be motivated to modify Vad as there is no sufficient motivation or detail of the rounded triangular portion of the handle. Additionally, MPEP 2144.04 B. would not apply in such a modification. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) (The court held that the configuration of the claimed disposable plastic nursing container was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant.). In this case, the facts as present the pending application notes that the rounded triangular-shape along with the angling of the yoke that comprises the proximal end of the proximal handle portion results in the benefit of “because it reduces the angle, with respect to a lengthwise axis of delivery device 100, needed for a line of sight to visualize the point at which delivery device 100 enters an opening in a body of a patient” as noted in [0065] of the patent application publication. There is no such similar functionally noted in Crisostomo, hence the facts of the case do apply as there is persuasive evidence that this particular configuration of this claimed handle is significant. Wilger et al (US 20210307946 A1) teaches a delivery device for delivering an implantable medical device into a body lumen of a patient with a handle assembly with a proximal handle portion and a distal handle portion with a transition portion in between the two, but does not teach the proximal handle portion having a rounded triangular cross-sectional shape. Khuu et al (US 20180071488 A1) teaches a delivery device for delivering an implantable medical device into a body lumen of a patient with a handle assembly with a proximal handle portion and a distal handle portion with a transition portion in between the two, but does not teach the proximal handle portion having a rounded triangular cross-sectional shape.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Wilger et al (US 20210307946 A1) teaches a delivery device for delivering an implantable medical device into a body lumen of a patient with a handle assembly with a proximal handle portion and a distal handle portion with a transition portion in between the two, but does not teach the proximal handle portion having a rounded triangular cross-sectional shape
Khuu et al (US 20180071488 A1) teaches a delivery device for delivering an implantable medical device into a body lumen of a patient with a handle assembly with a proximal handle portion and a distal handle portion with a transition portion in between the two, but does not teach the proximal handle portion having a rounded triangular cross-sectional shape
Crisostomo et al (US 20130144276 A1) teaches a delivery device for delivering an implantable medical device into a body lumen of a patient with a handle assembly with a proximal handle portion and a distal handle portion with a transition portion in between the two, however does not teach wherein the proximal handle portion has a side length equal to the length of one side of the triangular cross-sectional shape of the proximal handle portion; and wherein the second outer diameter is less than the side length
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAIHAN R KHANDKER whose telephone number is (571)272-6174. The examiner can normally be reached Monday - Friday 8:00 AM - 5:00 PM.
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RAIHAN R. KHANDKER
Examiner
Art Unit 3771
/RAIHAN R KHANDKER/Examiner, Art Unit 3771 /RAIHAN R KHANDKER/Examiner, Art Unit 3771
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