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 .
Election/Restrictions
Claim 3 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected product, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 09/24/2025.
Applicant’s election without traverse of Group I in the reply filed on 09/24/2025 is acknowledged.
Specification
The disclosure is objected to because of the following informalities:
Para. 0020, lines 1-2, the phrase “the lever mechanism 150 is formed with a third set of features symmetrically disposed on top of a flat circular plate 125 for providing outward tension…” should read “the lever mechanism 150 is formed with a third set of features symmetrically disposed on top of the lever plate 151 for providing outward tension”,
Para. 0023, line 2, the phrase “the lever 151” should read “the lever plate 151”,
Para. 0023, line 4, the phrase “the lever 150” should read “the lever mechanism 150”
Appropriate correction is required.
Claim Objections
Claim 10 and 16 are objected to because of the following informalities:
Regarding claim 10, the phrase “a plurality of third features” in line 11 should read “a pair of third features” to be consistent with the phrase “routed to the outside of a respective one of the pair of third features” in lines 12-13.
Regarding claim 16, the phrase “at a distal end of catheter tube” in line 2 should read “at a distal end of the catheter tube” for proper grammar,
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“a first feature” in claims 1 and 10,
“a plurality of second features” in claims 1 and 10,
“a plurality of third features” in claims 1 and 10,
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
Regarding “a first feature” in claims 1 and 10, 112(f) is invoked because: (i) it uses a generic placeholder (feature), (ii) it is coupled with functional language (for affixing the catheter tube), and (iii) it is not associated with structure in the claim. The specification is referenced for the corresponding structure. Fig. 3 and para. 0018 states “a saddle 123 formed as a first feature for securely holding the catheter tube in place at the front of the handle.” Examiner is interpreting the limitation as this structure and equivalents thereof.
Regarding “a plurality of second features” in claims 1 and 10, 112(f) is invoked because: (i) it uses a generic placeholder (plurality of features), (ii) it is coupled with functional language (to provide inward tension to the pair of guidewire legs as the elver plate is rotated), and (iii) it is not associated with structure in the claim. The specification is referenced for the corresponding structure. Fig. 3 and para. 0018 states “a pair of vertical posts 124 are symmetrically formed as second set of features… to provide inward tension on each guidewire leg 94 before it wraps around and attaches to the lever mechanism.” Examiner is interpreting the limitation as this structure and equivalents thereof.
Regarding “a plurality of third features” in claims 1 and 10, 112(f) is invoked because: (i) it uses a generic placeholder (plurality of features), (ii) it is coupled with functional language (to provide outward tension to the guidewire legs as the lever plate is rotated), and (iii) it is not associated with structure in the claim. The specification is referenced for the corresponding structure. Fig. 7 and para. 0021 discloses the lever plate 151 having a pair of semicircular walls 155 vertically and symmetrically disposed on each side of the lever plate 151, with each wall 155 ended in a respective knob portion 156a and 156b, and attached to a central portion outside of each wall 155 are corresponding structures 157a and 157b defining respective tunnels 158 and 158b. Examiner is interpreting the limitation as a symmetrically, vertically extending structures from the lever plate 151 that have features capable of providing outward tension onto the guidewire legs or equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 1-16 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.
Regarding claim 1, the phrase “a catheter tube having a guidewire affixed at both ends thereof inside a distal end of the catheter tube and a pair of guidewire legs extending from a proximate end of the catheter tube into the front portion of the housing” in lines 3-5 renders the claim indefinite because it is unclear. It is unclear if the two ends of the guidewire fixed inside the distal end of the catheter are related to the pair of guidewire legs that extend from a proximate end of the catheter tube. From the specification, para. 0017 states “the catheter tube 90 is affixed near the front end of the handle, and the center of the catheter guidewire 94 is fixed to the inside of the catheter tip at the distal end. The two legs of the guidewire extend from the proximate end of the catheter tube into the housing.” Thus, this limitation is being interpreted as the guidewire is affixed at the inside of the distal end of the catheter tube with its legs extending proximally into the housing.
Regarding claim 1, the phrase “a lever assembly affixed within the housing; a lever plate rotatably coupled with the lever assembly, the lever plate having at least one lever arm extending outside the housing and movable to rotate the lever plate on the lever assembly when operated” in lines 8-11 renders the claim indefinite because it is unclear. It is unclear, in light of the specification, how the lever plate can be rotatably coupled with and rotated on the lever assembly if the lever plate is a part of the lever assembly. Examiner points to para. 0016 and Fig. 7 stating “a lever mechanism 150 (see FIG. 2). The lever mechanism 150 is a substantially circular component that is rotatable within the circular portions 111, 121 by manually operating a lever arm 152 that extends from the lever mechanism” and para. 0020 stating “the circular plate 151 has lever arms 152 extending from opposite sides of the plate.” Thus, from the specification, it appears that the lever assembly is the entire lever mechanism 150 illustrated in Fig. 7 with the lever plate 151 a component of the assembly. Therefore, is it unclear how they are claimed as separate components, and how the lever plate is rotated on the lever assembly when operated. Examiner is interpreting this limitation as the lever assembly is affixed within the housing and comprising a lever plate, the lever plate and the lever assembly thus rotate together, and the lever plate having at least one lever arm extending outside the housing and movable to rotate the lever plate and thus the lever assembly when operated.
Regarding claim 1, the phrase “the lever plate having a pair of cable terminal points disposed symmetrically on the rear portion of the lever plate for connecting the pair of guidewire legs” in lines 11-12 renders the claim indefinite because it is unclear. Firstly, it is unclear, in light of the specification, what direction is considered “rear”. In para. 0017 and Fig. 2, the cable terminal points are designated as points 96 illustrated on a distal side of the lever plate 151. However, in Fig. 2 and 7 and para. 0020 stating “two pairs of holes 153, 154 formed at the rear of the plate 151” which creates confusion as these holes 153 and 154 are formed on the opposite side from the points 96. Secondly, it is unclear if the pair of guidewire legs are connected to the lever plate at the pair of cable terminal points as claimed, or if these points are just locations that a connection is formed disposed over the lever plate at some point in time during operation. Examiner is interpreting this limitation as the pair of cable terminal points are locations for connection disposed symmetrically near the edge portion of the lever plate at some point in time during operation and using the definition of rear broadly as a space or position near a hindmost or back portion of something (see Oxford Languages for definition of “rear”).
Regarding claim 2, the phrase “a cable having a pair of ends coupled to the guidewire legs adjacent the lever plate, the cable wrapped around the lever via the third features and affixed at the cable terminal points” in lines 2-3 renders the claim indefinite because it is unclear. Firstly, it is unclear what structure is being referred to as “the lever” i.e. lever assembly, lever plate, lever arm. Examiner is interpreting this as the lever assembly. Secondly, it is unclear, in light of the 112(b) rejection of claim 1 discussed above with the cable terminal points, if the cable is affixed to the lever plate at the cable terminal points or if the cable is affixed to the guidewire legs at points in space disposed over the lever plate at a point in time during operation. If it’s the latter case, then this raises confusion in claim 2 how the coupling is occurring adjacent the lever plate if the cable terminal points are a point disposed on a rear portion of the lever plate. Examiner is interpreting this limitation as the pair of cable terminal points are locations for connection disposed symmetrically near the edge portion of the lever plate or adjacent the lever plate at a point in time during operation, wherein the pair of cable ends couple to the guidewire legs at the cable terminal points.
Regarding claim 9, the phrase “a first one of the pair of cable ends is coupled to a first one of the pair of guidewire legs adjacent the lever plate” in lines 4-5 and “wherein a second of the pair of cable ends is coupled to a second one of the pair of guidewire legs adjacent the lever plate” in lines 11-12 render the claim indefinite because they are unclear. It is unclear, in light of the 112(b) rejection of claim 1 discussed above with the cable terminal points, if the guidewire legs are connected at the pair of cable terminal points which are disposed on the lever plate then how is the cable being coupled to the guidewire legs adjacent the lever plate. Examiner is interpreting this limitation as the pair of cable terminal points are locations for connection disposed symmetrically near the edge portion of the lever plate either on or adjacent the lever plate at some point in time during operation, wherein the pair of cable ends couple to the guidewire legs at the cable terminal points.
Regarding claim 10, the phrase “each one of the pair of guidewire legs is affixed to a respective one of the terminal points” in lines 7-8 renders the claim indefinite because it is unclear. It is unclear, in light of the specification Fig. 2 and para. 0017, if the pair of terminal points are a point on the lever mechanism such that the guidewire legs are affixed to the lever mechanism or that they form a connection with another structure at that point that is disposed over the lever mechanism at some point during operation. Examiner is interpreting this limitation as the pair of terminal points are locations for connection disposed symmetrically on the lever mechanism, wherein the pair of cable ends are fixed to the guidewire legs at the terminal points.
Claim 15 recites the limitation "the lever plate" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 15, the phrase “a first one of the pair of cable ends is coupled to a first one of the pair of guidewire legs adjacent the lever mechanism” in lines 4-5 and “wherein a second of the pair of cable ends is coupled to a second one of the pair of guidewire legs adjacent the lever mechanism” in lines 11-12 render the claim indefinite because they are unclear. It is unclear, in light of the 112(b) rejection of claim 10 discussed above with the terminal points, if the guidewire legs are connected at the pair of terminal points which are disposed on the lever mechanism then how is the cable being coupled to the guidewire legs adjacent the lever mechanism. Examiner is interpreting this limitation as the pair of terminal points are locations for connection disposed symmetrically on or adjacent the lever mechanism at some point in time during operation, wherein the pair of cable ends couple to the guidewire legs at the terminal points.
Claim 16 recites the limitation "the lever plate" in line 13, again in line 15, and again in line 16. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 16, the phrase “wherein each one of the pair of guidewire legs is routed to the outside of a respective one of the pair of vertical walls and then affixed to the back of the lever plate” in lines 14-15 renders the claim indefinite because it is unclear. It is unclear whether the guidewire is what is routed around the vertical walls and affixed to the lever plate or the cable as disclosed in the disclosure, for example in Fig. 2 and para. 0020). Examiner is interpreting this limitation as the cable is routed to the outside of the vertical walls and affixed to the back of the lever plate, and the cable is coupled to the guidewire.
Regarding claims 2-8 and 11-14, these claims are rejected due to their dependency upon a rejected base claim.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-2, 4-5, and 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Yu et al. (U.S Patent Pub. No. 20180085558 A1, “Yu”) in view of Osypka (U.S Patent Pub. No. 20150057655 A1) in view of Pederson et al. (W.O Patent Pub. No. 2023052240 A1, “Pederson”).
Regarding claim 1, Yu discloses the limitations of (Claim 1) a control handle (10) for a steerable catheter (14, see at least Fig. 1-5 and para. 0029), comprising: a housing (16, 18, and 20) having a front portion including an opening (distal opening of 16, see Fig. 2 and para. 0030 – housing is interpreted as the combined structure of distal strain relief 16, upper housing 18, and lower housing 20 with the front portion being interpreted as the portion of the housings 18 and 20 distal the lever assembly 12 and
PNG
media_image1.png
464
712
media_image1.png
Greyscale
the distal strain relief 16, see annotated Yu drawing 1 below for front portion),
the opening (16) adapted for receiving a catheter tube (14) having a guidewire (30, 32) affixed at both ends thereof inside a distal end (17) of the catheter tube (14) and a pair of guidewire legs (30, 32) extending from a proximate end (15) of the catheter tube (14) into the front portion (16) of the housing (16, 18, and 20, see Fig. 1-2 and 4 and para. 0031); a lever assembly (12) affixed within the housing (16, 18, and 20, see Fig. 2 and para. 0029-0030); a lever plate (60) rotatably coupled with the lever assembly (12, see Fig. 3-4 and para. 0031 – examiner notes, in light of the 112(b) rejection above, this limitation is being interpreted as the lever plate is a component of the lever assembly and thus rotate together), the lever plate (60) having at least one lever arm (22) extending outside the housing (16, 18, and 20) and movable to rotate the lever plate (60) on the lever assembly (12) when operated (examiner notes, in light of the 112(b) rejection above, this limitation is being interpreted as the lever arm is movable to rotate the lever plate and thus also the lever assembly when operated, see Fig. 3-4 and para. 0010, 0029, and 0031-0032 – lever plate 60 is mounted to the lever arm 22 which can be rotated by a user to rotate the lever plate 60 and thus assembly 12 to cause deflection), a pair of cable terminal points (34) disposed symmetrically for connecting the pair of guidewire legs (30, 32, see Fig. 5 and para. 0030); a plurality of second features (40) disposed symmetrically within the front portion of the housing (16, 18, and 20) adjacent the lever plate (60) and lever assembly (12) and positioned to provide inward tension to the pair of guidewire legs (30, 32) as the lever plate (60) is rotated (examiner notes the plurality of second features are interpreted under 112(f) as a pair of vertical posts capable of providing inward tension to the pair of guidewire legs or an equivalent structure, see annotated Yu drawing 1 above for front portion of housing and see Fig. 5 and para.0010, 0029, and 0038 – the pair of vertical rollers 40 are positioned to guide the cables 36 and thus the guidewire legs 30 and 32 in an inward direction as the lever plate 60 and assembly 12 are rotated during operation); and a plurality of third features (42, 44) disposed symmetrically on the lever plate (60) and positioned to provide outward tension to the guidewire legs (30, 32) as the lever plate (60) is rotated (examiner notes the plurality of third features are interpreted under 112(f) as symmetrically, vertically extending structures from the lever plate that have features capable of providing outward tension onto the guidewire legs or equivalents thereof, see Fig. 4 and para. 0010, 0029, and 0030 - guide walls 42 and 44 are symmetrical and vertically extending walls from the plate 60 that provide outward tension to the cables 36 and thus guidewire legs 30 and 32).
However, Yu fails to disclose the limitations of (Claim 1) a first feature formed proximate the opening in the front portion of the housing for affixing the catheter tube, the lever plate having a pair of cable terminal points disposed symmetrically on a rear portion of the lever plate for connecting the pair of guidewire legs, the plurality of second features spaced apart from the first feature.
Osykpa discloses a steering handle (116 in Fig. 2B-2C) for a steerable catheter (110), wherein the steering handle (116) comprises (Claim 1) a first feature (127a, 127b, and 129) formed proximate the opening (129a) in the front portion of the housing (116a,116b) for affixing the catheter tube (112, examiner notes the first feature is being interpreted under 112(f) as a saddle for securely holding the catheter tube in place or an equivalent structure, see Fig. 2B-2C and para. 0097 – the halves 116a,116b together form the housing having a front portion interpreted as the portion of the housing seen in Fig. 2B-2C distal of the actuation mechanism 120, the two holder halves 127a-127b and have a saddle-shape that holds stabilizing member 129 which together securely affix the catheter tube 112).
Therefore, 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 front portion of the housing of the handle taught by Yu to incorporate a first feature for securely holding the catheter tube in place as taught by Osykpa. The stabilizing member holders (127a,127b) and the stabilizing holder (129) allows the catheter tube to be directed into the handle and ensures that motion of the catheter tube within the handle can be resisted (see para. 0097). In combination, Yu in view of Osykpa disclose the limitation of (Claim 1) a plurality of second features spaced apart from the first feature, as the stabilizing member holders (127a,127b) and stabilizing holder (129) of Osykpa would be incorporated into the front portion of the housing of the handle (116, 118, and 120) of Yu at a location distal to the plurality of second features (40).
However, Yu in view of Osykpa fail to disclose the limitations of (Claim 1) the lever plate having a pair of cable terminal points disposed symmetrically on a rear portion of the lever plate for connecting the pair of guidewire legs.
Pederson discloses a handle (5) for a steerable endoscope (1), wherein the handle (5) comprises a lever plate (81) and a cable (191a) that couples to a guidewire leg (192a) at a cable terminal point (88, see Fig. 4). This limitation of claim 1 is interpreted, in light of the 112(b) rejection of claim 1 above, as the cable terminal point is a location for connection disposed near or on the edge portion of the lever plate at some point in time during operation using the definition of rear broadly as a space or position near a hindmost or back portion of something, and thus Pederson teaches (Claim 1) the lever plate (81) having a cable terminal point (88) as a location for connection disposed near the edge of a hindmost or back portion of the lever plate (81, see Fig. 4 and p.4, lines 5-12). Examiner notes that during operation, the cable terminal point (88) will be rotated and translated such that it may be disposed over the lever plate (81) at some point in time.
Since modified Yu discloses a pair of cable terminal points (34) disposed symmetrically for connecting the pair of guidewire legs (30, 32) to a cable (36, see Fig. 5 and para. 0030), and Pederson teaches a cable terminal point (88) as a location for connection of a guidewire leg (192a) and a cable (191a) that is disposed near the edge of a hindmost or back portion of the lever plate (81), 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 location of the pair of cable terminal points taught by modified Yu to be near the edge of the hindmost or back portion of the lever plate as taught by Pederson. Pederson teaches that the crimp connecting the guidewire and cable is at an easily accessible location as seen in Fig. 4-5 (see Col.10, lines 5-12). Further, examiner notes that modifying the location of the crimp would be an obvious modification as claimed by known methods to yield predictable results as it only involves modifying the location of the coupling of the guidewire leg and the cable to be closer to the lever plate, and during rotation of the lever assembly, the cable terminal point will move so as to be disposed over the lever plate at some point in time.
Regarding claim 2, modified Yu discloses the control handle of claim 1, as discussed above. In modified Yu, Yu discloses the limitations of (Claim 2) further comprising: a cable (36) having a pair of ends coupled to the guidewire legs (30, 32), the cable (36) wrapped around the lever (12) via the third features (42, 44) and affixed at the cable terminal points (34, see Fig. 5 and para. 0030 – cable 36 is formed of two fibers 36 each having an end coupled to the guidewire legs 30 and 32 at crimp 34 and then each fiber 36 is wrapped around each third features 42 and 44 of the lever 12).
In modified Yu, Pederson discloses the limitation that the cable (191a) has an end coupled to the guidewire leg (192a) at a cable terminal point (88) adjacent the lever plate (81, see Fig. 4-5).
Thus, in combination, modified Yu would have a cable (36) having a pair of ends coupled to the guidewire legs (30, 32) adjacent the lever plate (60).
Regarding claim 4, modified Yu discloses the control handle of claim 1, as discussed above. In modified Yu, Yu discloses (Claim 4) the plurality of second features (40) comprises a pair of vertical posts (see Fig. 4-5).
Regarding claim 5, modified Yu discloses the control handle of claim 1, as discussed above. In modified Yu, Yu discloses (Claim 5) the plurality of third features (42, 44) comprises a pair of semicircular vertical walls (see Fig. 4-5).
Regarding claim 10, Yu discloses the limitations of (Claim 10) a control handle (10) for a catheter having a guidewire (30, 32) enclosed within a catheter tube (14) and having a pair of guidewire legs (30, 32) extending from a proximate end (15) of the catheter tube (14, see at least Fig. 1-5 and para. 0029-0030), comprising: a housing (16, 18, and 20), see Fig. 2 and para. 0030 - housing is interpreted as the combined structure of distal strain relief 16, upper housing 18, and lower housing 20), a lever mechanism (12) rotatably coupled within an interior region of the housing (16, 18, and 20) and having a lever arm (22) extending from the housing (16, 18, and 20) for rotating the lever mechanism (12) and a pair of terminal points (34) symmetrically disposed (see Fig. 4-5 and para. 0010, 0029, 0031), each one of the pair of guidewire legs (30, 32) is affixed to a respective one of the terminal points (34, see Fig. 5 and para. 0030); a pair of second features (40) formed and symmetrically disposed in the interior region of the housing (16, 18, and 20, see Fig. 3 and 5 and para. 0029 and 0038), each one of the pair of guidewire legs (30, 32) is routed to the inside of a respective one of the pair of second features (40) in order to provide inward tension to the guidewire leg (30, 32) as the lever plate (60) is rotated (see Fig. 5 and para. 0010, 0029, and 0038); and a plurality of third features (42, 44) formed and symmetrically disposed on the lever mechanism (12, examiner notes the plurality of third features are interpreted under 112(f) as symmetrically, vertically extending structures from the lever plate that have features capable of providing outward tension onto the guidewire legs or equivalents thereof, see Fig. 4 and para. 0029-0030), each one of the pair of guidewire legs (30, 32) is routed to the outside of a respective one of the pair of third features (42, 44) and then affixed to the respective one of the terminal point (34) in order to provide outward tension to the guidewire legs (30, 32) as the lever plate (60) is rotated (see Fig. 4 and para. 0010, 0029, and 0030 - guide walls 42 and 44 are symmetrical and vertically extending walls from the plate 60 that provide outward tension to the cables 36 and thus guidewire legs 30 and 32).
However, Yu fails to disclose the limitations of (Claim 10) a pair of terminal points symmetrically disposed on the lever mechanism, a first feature formed in the interior region of the housing for affixing the proximate end of the catheter tube; the pair of second features symmetrically disposed between the first feature and the lever mechanism.
Osykpa discloses a steering handle (116 in Fig. 2B-2C) for a steerable catheter (110), wherein the steering handle (116) comprises (Claim 10) a first feature (127a, 127b, and 129) formed in the interior region of the housing (116a, 116b) for affixing the proximate end of the catheter tube (112, examiner notes the first feature is being interpreted under 112(f) as a saddle for securely holding the catheter tube in place or an equivalent structure, see Fig. 2B-2C and para. 0097 – the halves 116a,116b together form the housing which comprise the two holder halves 127a-127b and have a saddle-shape that holds stabilizing member 129 which together securely affix the proximal end of the catheter tube 112).
Therefore, 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 housing of the handle taught by Yu to incorporate a first feature for securely holding the catheter tube in place as taught by Osykpa. The stabilizing member holders (127a,127b) and the stabilizing holder (129) allows the catheter tube to be directed into the handle and ensures that motion of the catheter tube within the handle can be resisted (see para. 0097). In combination, Yu in view of Osykpa disclose the limitation of (Claim 10) a pair of second features formed and symmetrically disposed in the interior region of the housing between the first feature and the lever mechanism, as the stabilizing member holders (127a,127b) and stabilizing holder (129) of Osykpa would be incorporated into the front portion of the housing of the handle (116, 118, and 120) of Yu at a location distal to the pair of second features (40), placing the pair of second features (40) between the first feature and the lever mechanism (12).
However, Yu in view of Osykpa fail to disclose the limitations of (Claim 10) a pair of terminal points symmetrically disposed on the lever mechanism.
Pederson discloses a handle (5) for a steerable endoscope (1), wherein the handle (5) comprises a lever mechanism (81) and a cable (191a) that couples to a guidewire leg (192a) at a terminal point (88, see Fig. 4). This limitation of claim 10 is interpreted, in light of the 112(b) rejection of claim 10 above, as the terminal point is a location for connection disposed near or on the lever mechanism at some point in time during operation, and thus Pederson teaches (Claim 10) the lever mechanism (81) having a terminal point (88) as a location for connection disposed near or on the lever mechanism (81) at some point in time (see Fig. 4 and p.4, lines 5-12). Examiner notes that during operation, the terminal point (88) will be rotated and translated such that it may be disposed over the lever mechanism (81) at some point in time.
Since modified Yu discloses a pair of terminal points (34) disposed symmetrically for connecting the pair of guidewire legs (30, 32) to a cable (36, see Fig. 5 and para. 0030), and Pederson teaches a terminal point (88) as a location for connection of a guidewire leg (192a) and a cable (191a) that is disposed near or on the lever mechanism (81) at some point in time during operation, 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 location of the pair of cable terminal points taught by modified Yu to be near or on of the lever mechanism at some point in time during operation as taught by Pederson. Pederson teaches that the crimp connecting the guidewire and cable is at an easily accessible location as seen in Fig. 4-5 (see Col.10, lines 5-12). Further, examiner notes that modifying the location of the crimp would be an obvious modification as claimed by known methods to yield predictable results as it only involves modifying the location of the coupling of the guidewire leg and the cable to be closer to the lever mechanism, and during rotation of the lever mechanism, the terminal point will move so as to be disposed over the lever mechanism at some point in time.
Regarding claim 11, modified Yu discloses the control handle of claim 10, as discussed above. In modified Yu, Yu discloses (Claim 11) the pair of second features (40) comprises a pair of vertical posts (see Fig. 4-5).
Regarding claim 12, modified Yu discloses the control handle of claim 10, as discussed above. In modified Yu, Yu discloses (Claim 12) the plurality of third features (42, 44) comprises a pair of semicircular vertical walls (see Fig. 4-5).
Claim(s) 6 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Yu in view of Osypka in view of Pederson as applied to claims 5 and 12, respective, above, and further in view of Mogul (U.S Patent Pub. No. 20170014600 A1) with reference to Mogul (U.S Patent Pub. No. 20050288627 A1, “Mogul 2”) which is disclosed as being incorporated by reference therein (see Mogul, para. 0007) and in view of Hassoun (U.S Patent Pub. No. 20150305797 A1).
Regarding claim 6, modified Yu discloses the control handle of claim 5, as discussed above. In modified Yu, Yu discloses the limitations of (Claim 6) the pair of semicircular vertical walls (42, 44, see Fig. 5).
However, modified Yu fails to disclose (Claim 6) each of the pair of semicircular vertical walls further comprising a knob portion formed at a front end of the respective semicircular vertical wall and having a thickness greater than the respective semicircular vertical wall.
Mogul discloses a handle (see Fig. 4) for a steerable catheter, wherein the handle comprises a lever mechanism (70) having a pair of walls (76, 78) that outwardly tension the guidewire (see Fig. 4 and 7 and para. 0031). Mogul teaches (Claim 6) each of the pair of walls (76, 78) further comprising a knob portion (77, 79) formed at a front end of the respective wall (76, 78, see Fig. 7-9 and para. 0031).
Therefore, 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 semicircular, vertical walls taught by modified Yu to have a knob portion at their front ends as taught by Mogul as the knob portions increase the mechanical advantage of the lever when engaging the guidewire (see para. 0031).
However, modified Yu fails to explicitly disclose the knob portions having a thickness greater than the respective semicircular vertical wall. Hassoun discloses an endoscopic instrument (100) having a control handle (122) formed of a ball (138) and socket (136) assembly that together function as a lever assembly when the arm 139(b) of the ball (138) is manipulated which pivots the ball (138) and thus the attached cables (108a and 108b) around a pair of semicircular walls of the socket (136, see Fig. 8-9 and para. 0032 and 0065), wherein Hassoun teaches (Claim 6) each of the pair of semicircular walls of socket (136) further comprising a knob portion (163) formed at a front end of the respective wall and having a thickness greater than the respective semicircular wall (see annotated Hassoun drawing 1 below for walls, see Fig. 9 and para. 0032 – elevated portions 163 are elevated off of the surface of the socket 136 and thus have a greater thickness than each surrounding, semicircular wall of the socket 136).
PNG
media_image2.png
626
805
media_image2.png
Greyscale
Since Mogul discloses the knob portions (77, 79) formed at the front end of each respective wall (76, 78), and Hassoun teaches a knob portion formed by an elevated portion (163) on each respective wall of the socket (136), it would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the knob portions of modified Yu to have a thickness greater than the respective wall as taught by Hassoun. Hassoun teaches that a thicker portion of the respective walls such as an elevated portion allows for the cable to be guided and supported as they travel to their anchoring mechanism (139a,139b) on the lever assembly (138, 136, see para. 0032). Further, Mogul teaches towards a more pronounced knob portion as the knob portions (77, 79) of Mogul are disclosed as increasing the mechanical advantage of the lever when the knob portions (77, 79) engage with the cable (see para. 0031).
Regarding claim 13, modified Yu discloses the control handle of claim 12, as discussed above.
In modified Yu, Yu discloses the limitations of (Claim 13) the pair of semicircular vertical walls (42, 44, see Fig. 5).
However, modified Yu fails to disclose (Claim 13) each of the pair of semicircular vertical walls further comprising a knob portion formed at a front end of the respective semicircular vertical wall and having a thickness greater than the respective semicircular vertical wall in order to provide additional outward tension to the guidewire leg.
Mogul discloses a handle (see Fig. 4) for a steerable catheter, wherein the handle comprises a lever mechanism (70) having a pair of walls (76, 78) that outwardly tension the guidewire (see Fig. 4 and 7 and para. 0031). Mogul teaches (Claim 13) each of the pair of walls (76, 78) further comprising a knob portion (77, 79) formed at a front end of the respective wall (76, 78, see Fig. 7-9 and para. 0031).
Therefore, 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 semicircular, vertical walls taught by modified Yu to have a knob portion at their front ends as taught by Mogul as the knob portions increase the mechanism advantage of the lever when engaging the guidewire (see para. 0031).
However, modified Yu fails to explicitly disclose the knob portions having a thickness greater than the respective semicircular vertical wall in order to provide additional outward tension to the guidewire leg.
Hassoun discloses an endoscopic instrument (100) having a control handle (122) formed of a ball (138) and socket (136) assembly that together function as a lever assembly when the arm 139(b) of the ball (138) is manipulated which pivots the ball (138) and thus the attached cables (108a and 108b) around a pair of semicircular walls of the socket (136, see Fig. 8-9 and para. 0032 and 0065), wherein Hassoun teaches (Claim 13) each of the pair of semicircular walls of socket (136) further comprising a knob portion (163) formed at a front end of the respective wall and having a thickness greater than the respective semicircular wall in order to provide additional outward tension to the cable (108a, 108b, see annotated Hassoun drawing 1 above for walls, see Fig. 9 and para. 0032 and 0055 – elevated portions 163 are elevated off of the surface of the socket 136 and thus have a greater thickness than each surrounding, semicircular wall of the socket 136 which would be capable of providing additional outward tension to the cables 108a and 108b).
Since Mogul discloses the knob portions (77, 79) formed at the front end of each respective wall (76, 78), and Hassoun teaches a knob portion formed by an elevated portion (163) on each respective wall of the socket (136), it would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the knob portions of modified Yu to have a thickness greater than the respective wall as taught by Hassoun. Hassoun teaches that a thicker portion of the respective walls such as an elevated portion allows for the cable to be guided and supported as they travel to their anchoring mechanism (139a,139b) on the lever assembly (138, 136, see para. 0032). Further, Mogul teaches towards a more pronounced knob portion as the knob portions (77, 79) of Mogul are disclosed as increasing the mechanical advantage of the lever when the knob portions (77, 79) engage with the cable (see para. 0031).
Claim(s) 7 is rejected under 35 U.S.C. 103 as being unpatentable over Yu in view of Osypka in view of Pederson as applied to claim 5, above, and further in view of Kobayashi (W.O Patent Pub. No. 2013008490 A1).
Regarding claim 7, modified Yu discloses the control handle of claim 5, as discussed above. In modified Yu, Yu discloses the limitation of (Claim 7) the pair of semicircular vertical walls (42, 44, see Fig. 5).
However, modified Yu fails to disclose (Claim 7) further comprising: a pair of tunnels, each tunnel formed adjacent a respective one of the pair of semicircular vertical walls and sized to route therethrough a respective one of the pair of guidewire legs.
Kobayashi discloses a catheter handle (1) for a steerable catheter tube having two operation wires (32, see Fig. 1), wherein the catheter handle (1) comprises a rotating plate (3A) with symmetrical, vertically extending guide rails (231, 241, see Fig. 3B and para. 031). Kobayashi teaches (Claim 7) further comprising: a pair of tunnels, each tunnel formed adjacent a respective one of the pair of semicircular vertical walls (231, 241) and sized to route therethrough a respective one of the pair of guidewire legs (32, see Fig. 2-3B and para. 044 – the first pair of guide rails 231, 241 form the semicircular vertical walls in which the guidewire legs 32 are routed on the outside thereof, with the addition of a second pair of guide rails 232, 242 a tunnel is formed between the first 231, 241 and second 232, 242 pairs of guide rails in which the guidewire legs 32 are routed through, examiner notes onelook.com dictionary defines a “tunnel” as a passage through or under an obstacle and thus the passage through the first and second pairs of guide rails is interpreted as a tunnel).
Therefore, 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 lever plate taught by modified Yu to have a second pair of walls such as to form tunnels as taught by Kobayashi. Kobayashi teaches that by providing concentric guide rails, a path is defined for the operation wire and the amount of tension to the wire and thus the bending size of the distal portion of the catheter tube can be adjusted by routing the wire through a chosen path provided by the concentric guide rails (see para. 013 and 014-015).
Claim(s) 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Yu in view of Osypka in view of Pederson as applied to claim 4, above, and further in view of Mogul with reference to Mogul (U.S Patent Pub. No. 20050288627 A1, “Mogul 2”) which is disclosed as being incorporated by reference therein (see Mogul, para. 0007) and in view of Hassoun (U.S Patent Pub. No. 20150305797 A1) in view of Kobayashi (W.O Patent Pub. No. 2013008490 A1).
Regarding claim 8, modified Yu discloses the control handle of claim 4, as discussed above. In modified Yu, Yu discloses the limitations of (Claim 8) further comprising: a pair of semicircular vertical walls (42, 44, see Fig. 4-5), wherein each leg of the pair of guidewire legs (30, 32) is routed inside one a respective on of the vertical posts (40) then around the outside of a respective one of the pair of semicircular walls (42, 44, see Fig. 4-5 and para. 0010, 0029, and 0030).
However, modified Yu fails to disclose the limitations of (Claim 8) each semicircular vertical wall having a knob portion formed at a front end thereof, the knob portion having a thickness greater than the respective semicircular vertical wall; and a pair of tunnels, each tunnel formed adjacent a respective one of the pair of semicircular walls; wherein each leg of the pair of guidewire legs is routed through a respective one of the pair of tunnels on the lever plate.
Mogul discloses a handle (see Fig. 4) for a steerable catheter, wherein the handle comprises a lever mechanism (70) having a pair of walls (76, 78) that outwardly tension the guidewire (see Fig. 4 and 7 and para. 0031). Mogul teaches (Claim 8) each semicircular vertical wall (76, 78) having a knob portion (77, 79) formed at a front end thereof (see Fig. 7-9 and para. 0031).
Therefore, 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 semicircular, vertical walls taught by modified Yu to have a knob portion at their front ends as taught by Mogul as the knob portions increase the mechanism advantage of the lever when engaging the guidewire (see para. 0031).
However, modified Yu fails to explicitly disclose the knob portions having a thickness greater than the respective semicircular vertical wall.
Hassoun discloses an endoscopic instrument (100) having a control handle (122) formed of a ball (138) and socket (136) assembly that together function as a lever assembly when the arm 139(b) of the ball (138) is manipulated which pivots the ball (138) and thus the attached cables (108a and 108b) around a pair of semicircular walls of the socket (136, see Fig. 8-9 and para. 0032 and 0065), wherein Hassoun teaches (Claim 8) each semicircular walls of socket (136) having a knob portion (163) formed at a front end thereof (see annotated Hassoun drawing 1 below for walls, see Fig. 9 and para. 0032), the knob portion (163) having a thickness greater than the respective semicircular wall (see annotated Hassoun drawing 1 below for walls, see Fig. 9 and para. 0032 – elevated portions 163 are elevated off of the su