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 .
Claims Pending
Claims 1-20 are currently pending.
Election/Restrictions
Applicant’s election without traverse of Invention 1, Species A2, Claims 1-15, in the reply filed on 03/26/2026 is acknowledged.
Claims 16-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected Inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03/26/2026.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Claims 1-15 are currently under examination.
Claim Objections
Claims 5, 7, and 11-15 objected to because of the following informalities:
In claim 5, “element controlling” (line 2), should read -element for controlling-,
In claim 5, “element controlling” (line 4), should read -element for controlling-,
In claim 7, “a two-way steering system” (line 4), should read -a third two-way steering system-,
In claim 11, “operatively associated with the first flexible elongate steering element to steer the steerable flexible elongate member in a first direction, and to the second flexible elongate steering element to steer the steerable flexible elongate member in a second direction different from the first direction”, should read -operatively associated with the first flexible elongate steering element to steer the steerable flexible elongate member in a first direction, and with the second flexible elongate steering element to steer the steerable flexible elongate member in a second direction different from the first direction- (Examiner's Note: substitution of the phrase “and to…” to recite -and with-),
In claim 12, “element controlling” (line 2), should read -element for controlling-,
In claim 12, “element controlling” (line 4), should read -element for controlling-,
Claim s 8-9 are dependent on claim 7, and as such are also objected to,
Claims 12-15 are dependent on claim 11, and as such are also objected to.
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:
Claim 14: The claim limitation “steering gear pulley assemblies comprises a gear with a gear barrel extending therefrom and configured for coupling a flexible elongate steering element thereto” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “assemblies” coupled with functional language “configured for coupling a flexible elongate steering element thereto” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “assemblies”.
Claim 14: The claim limitation “the steering gear pulley assembly configured to maintain the position of the flexible elongate steering element on the gear barrel without being entangled with the gear” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “assembly” coupled with functional language “configured to maintain the position of the flexible elongate steering element on the gear barrel without being entangled with the gear” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “assembly”.
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.
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation:
“adhering, welding, brazing, soldering, etc…”, or equivalents thereof, as described on Page 15 (third to last line) of the disclosure filed on 06/19/2023.
“gear barrel 264 includes a bulge or bump 268…”, or equivalents thereof, as described on Page 15 (last two lines) of the disclosure filed on 06/19/2023.
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.
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 1-15 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.
The term “flexible” in claims 1 and 11 is a relative term which renders the claim indefinite. The term “flexible” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The applicant has failed to effectively define the metes and bounds of the claim as it is unclear how “flexible” the applicant considers to be the “flexible elongate member”. Is this linked to the actual material of the member? How flexible is “flexible”? As such, the claim is indefinite as the applicant has failed to effectively define the metes and bounds of the claim. For examination purposes, this will be interpreted as without the word “flexible”.
The term “flexible” in claims 1 and 11 is a relative term which renders the claim indefinite. The term “flexible” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The applicant has failed to effectively define the metes and bounds of the claim as it is unclear how “flexible” the applicant considers to be the “first flexible elongate steering element”. Is this linked to the actual material of the element? How flexible is “flexible”? As such, the claim is indefinite as the applicant has failed to effectively define the metes and bounds of the claim. For examination purposes, this will be interpreted as without the word “flexible”.
The term “flexible” in claims 1 and 11 is a relative term which renders the claim indefinite. The term “flexible” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The applicant has failed to effectively define the metes and bounds of the claim as it is unclear how “flexible” the applicant considers to be the “second flexible elongate steering element”. Is this linked to the actual material of the element? How flexible is “flexible”? As such, the claim is indefinite as the applicant has failed to effectively define the metes and bounds of the claim. For examination purposes, this will be interpreted as without the word “flexible”.
The term “flexible” in claim 7 is a relative term which renders the claim indefinite. The term “flexible” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The applicant has failed to effectively define the metes and bounds of the claim as it is unclear how “flexible” the applicant considers to be the “steerable flexible tubular elongate member”. Is this linked to the actual material of the member? How flexible is “flexible”? As such, the claim is indefinite as the applicant has failed to effectively define the metes and bounds of the claim. For examination purposes, this will be interpreted as without the word “flexible”.
Claims 8-9 are dependent on claim 7, and as such are also rejected.
The term “flexible” in claim 15 is a relative term which renders the claim indefinite. The term “flexible” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The applicant has failed to effectively define the metes and bounds of the claim as it is unclear how “flexible” the applicant considers to be the “third flexible elongate steering element”. Is this linked to the actual material of the element? How flexible is “flexible”? As such, the claim is indefinite as the applicant has failed to effectively define the metes and bounds of the claim. For examination purposes, this will be interpreted as without the word “flexible”.
The term “flexible” in claim 15 is a relative term which renders the claim indefinite. The term “flexible” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The applicant has failed to effectively define the metes and bounds of the claim as it is unclear how “flexible” the applicant considers to be the “fourth flexible elongate steering element”. Is this linked to the actual material of the element? How flexible is “flexible”? As such, the claim is indefinite as the applicant has failed to effectively define the metes and bounds of the claim. For examination purposes, this will be interpreted as without the word “flexible”.
Claim 10 recites the limitation “wherein gears of said first steering gear system rotate about respective first gear system axes parallel to one another” in lines 4-5. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, this will be interpreted as if the applicant previously indicated that the first steering gear system comprised a plurality of gears.
Claim 10 recites the limitation “gears of said second steering gear system rotate about respective second gear system axes” in lines 5-6. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, this will be interpreted as if the applicant previously indicated that the second steering gear system comprised a plurality of gears.
Claim 14 recites the limitation “the steering gear pulley assembly configured to maintain the position of the flexible elongate steering element on the gear barrel without being entangled with the gear”, which fails to effectively define the metes and bounds of the claim as it is unclear as to what steering gear pulley assembly is being referred to. Is this the first steering gear pulley assembly? Is this the second steering gear pulley assembly? Is this one of the steering gear assemblies? As such, the claim is indefinite as the applicant has failed to effectively define the metes and bounds of the claim. For examination purposes, this will be interpreted as ones of the steering gear assemblies.
Claim 15 recites the limitation “said control handle further comprising a control knob mounted on said control handle housing and operatively associated with a third flexible elongate steering element and a fourth flexible elongate steering element to steer the steerable flexible elongate member in a second steering plane transverse to the first steering plane”, which fails to effectively define the metes and bounds of the claim as it is unclear as to what control knob is being referred to. Is this the same control knob as presented in claim 11, which claim 15 is dependent on? Is this an entirely new control knob? As such, the claim is indefinite as the applicant has failed to effectively define the metes and bounds of the claim. For examination purposes, this will be interpreted as a second control knob.
Claims 2-10 are dependent on claim 1, and as such are also rejected.
Claims 12-15 are dependent on claim 11 and as such are also rejected.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
The claims are generally directed towards a medical device delivery system with a steerable elongate member and a steering system. The steering system comprises steering elements and a control handle associated with the steering elements to control the steering of the steerable elongate member.
Claim(s) 1-3, 6, 11, and 15 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Kien (US Pub. No. 20220331559) hereinafter Kien.
Regarding claim 1, Kien discloses A medical device delivery system (Par. 93, “Referring to FIG. 14, there are shown components of an actuating assembly 10 for a steerable catheter 12 (shown in FIG. 45…” (actuating assembly -10 for steerable catheter – 12)) comprising:
a steerable flexible elongate member (Par. 93, “The steerable catheter 12 is an example of a wire steered device usable with the actuating assembly 10”) (Par. 94, “The steerable catheter 12 is provided with at least one pair of steering wires 14 and 16 reaching the actuating assembly 10…”)(Par. 1, “The present invention relates to the general field of surgical devices, and is more particularly concerned with an actuating assembly for wire steered devices, such as flexible catheters or tubing provided with a steering or bending mechanism.”); and
a two-way steering system operatively associated with said steerable flexible elongate member (Fig. 14, actuating assembly – 10) (Par. 94, “The steerable catheter 12 is provided with at least one pair of steering wires 14 and 16 reaching the actuating assembly 10…”) (Par. 94, “the steering wires 14 and 16 steer the catheter 12 in a first plane”) (Fig. 14, knob -34) (Par. 97, “Wheels 24, 26, 28 and 30 are mounted in the actuating assembly cavity 23 and each receive a respective one of the steering wires 14, 16, 18 and 20 that it is mounted or secured thereto, for example using a wire attachment described in further details below…”) and comprising:
a first flexible elongate steering element (Par. 94, “The steerable catheter 12 is provided with at least one pair of steering wires 14 and 16 reaching the actuating assembly 10…”) (Fig. 14, steering wire - 14);
a second flexible elongate steering element (Par. 94, “The steerable catheter 12 is provided with at least one pair of steering wires 14 and 16 reaching the actuating assembly 10…”) (Fig. 14, steering wire - 16); and
a control handle operatively associated with the first flexible elongate steering element and the second flexible elongate steering element (Fig. 14, knob -34) (Par. 97, “Wheels 24, 26, 28 and 30 are mounted in the actuating assembly cavity 23 and each receive a respective one of the steering wires 14, 16, 18 and 20 that it is mounted or secured thereto, for example using a wire attachment described in further details below…”) (Par. 93, “FIGS. 1 to 16 show various aspects of a first embodiment of an actuating assembly 10…”) to control steering of the steerable flexible elongate member via the first flexible elongate steering element and the second flexible elongate steering element (Fig. 14, knob -34) (Par. 94, “the steering wires 14 and 16 steer the catheter 12 in a first plane”) (Par. 99, “The wheels 24, 26, 28 and 30 are rotated about the rotation axis by one of more actuators…” “… the actuators takes the form of knobs, such as the first and second knobs 34 and 36 provided outside of the actuating assembly body 22 are mounted thereto so as to be rotatable about the rotation axis 32.”) (Par. 100, “The actuating assembly 10 is configurable to an actuating configuration in which the first and second knobs 34 and 36 are operatively coupled respectively to the wheels 24 and 26 and to the wheels 28 and 30 so that the wheels 24 and 26 may be jointly rotated selectively clockwise or counter-clockwise by the first knob 34 and the wheels 28 and 30 may be jointly rotated selectively clockwise or counter-clockwise by the second knob 36.”) (Par. 100, “Such rotations will shorten the portion of one of the steering wires 14, 16, 18 and 20 that protrudes outside of the actuating assembly body 22 and lengthen the corresponding portion of the other steering wire 14, 16, 18 and 20 within a pair, which in turn will steers the catheter 12.”)).
Regarding claim 11, Kien discloses A control handle for controlling steering (Par. 93, “Referring to FIG. 14, there are shown components of an actuating assembly 10 for a steerable catheter 12 (shown in FIG. 45…” (actuating assembly -10 for steerable catheter – 12)) of a steerable flexible elongate member (Par. 93, “The steerable catheter 12 is an example of a wire steered device usable with the actuating assembly 10”) (Par. 94, “The steerable catheter 12 is provided with at least one pair of steering wires 14 and 16 reaching the actuating assembly 10…”) (Par. 1, “The present invention relates to the general field of surgical devices, and is more particularly concerned with an actuating assembly for wire steered devices, such as flexible catheters or tubing provided with a steering or bending mechanism.”) with a first flexible elongate steering element (Fig. 14, steering wire - 14) and a second flexible elongate steering element (Fig. 14, steering wire - 16) operatively associated with said steerable flexible elongate member (Par. 94, “The steerable catheter 12 is provided with at least one pair of steering wires 14 and 16 reaching the actuating assembly 10…”), said control handle comprising:
a control handle housing (Par. 96, “The actuating assembly 10 includes an actuating assembly body 22…”) (Fig. 14, actuating assembly body – 22); and
a control knob mounted on said control handle housing (Fig. 14, knob -34) (Par. 99, “the first and second knobs 34 and 36 may be provided on the same side of the actuating assembly body 22…”) and operatively associated with the first flexible elongate steering element to steer the steerable flexible elongate member in a first direction (Par. 97, “Wheels 24, 26, 28 and 30 are mounted in the actuating assembly cavity 23 and each receive a respective one of the steering wires 14, 16, 18 and 20 that it is mounted or secured thereto, for example using a wire attachment described in further details below…”) (Par. 94, “the steering wires 14 and 16 steer the catheter 12 in a first plane”) (Par. 99, “The wheels 24, 26, 28 and 30 are rotated about the rotation axis by one of more actuators…” “… the actuators takes the form of knobs, such as the first and second knobs 34 and 36 provided outside of the actuating assembly body 22 are mounted thereto so as to be rotatable about the rotation axis 32.”) (Par. 100, “The actuating assembly 10 is configurable to an actuating configuration in which the first and second knobs 34 and 36 are operatively coupled respectively to the wheels 24 and 26 and to the wheels 28 and 30 so that the wheels 24 and 26 may be jointly rotated selectively clockwise or counter-clockwise by the first knob 34 and the wheels 28 and 30 may be jointly rotated selectively clockwise or counter-clockwise by the second knob 36.”) (Par. 100, “Such rotations will shorten the portion of one of the steering wires 14, 16, 18 and 20 that protrudes outside of the actuating assembly body 22 and lengthen the corresponding portion of the other steering wire 14, 16, 18 and 20 within a pair, which in turn will steers the catheter 12.”)), and to the second flexible elongate steering element to steer the steerable flexible elongate member in a second direction different from the first direction (Fig. 14, knob -34) (Par. 94, “the steering wires 14 and 16 steer the catheter 12 in a first plane”) (Par. 99, “The wheels 24, 26, 28 and 30 are rotated about the rotation axis by one of more actuators…” “… the actuators takes the form of knobs, such as the first and second knobs 34 and 36 provided outside of the actuating assembly body 22 are mounted thereto so as to be rotatable about the rotation axis 32.”) (Par. 100, “The actuating assembly 10 is configurable to an actuating configuration in which the first and second knobs 34 and 36 are operatively coupled respectively to the wheels 24 and 26 and to the wheels 28 and 30 so that the wheels 24 and 26 may be jointly rotated selectively clockwise or counter-clockwise by the first knob 34 and the wheels 28 and 30 may be jointly rotated selectively clockwise or counter-clockwise by the second knob 36.”) (Par. 100, “Such rotations will shorten the portion of one of the steering wires 14, 16, 18 and 20 that protrudes outside of the actuating assembly body 22 and lengthen the corresponding portion of the other steering wire 14, 16, 18 and 20 within a pair, which in turn will steers the catheter 12.”)).
Regarding claim 2, Kien further discloses wherein said control handle includes a control knob operatively associated with said first flexible elongate steering element and said second flexible elongate steering element to control movement of said steerable flexible elongate member (Fig. 14, knob -34) (Par. 97, “Wheels 24, 26, 28 and 30 are mounted in the actuating assembly cavity 23 and each receive a respective one of the steering wires 14, 16, 18 and 20 that it is mounted or secured thereto, for example using a wire attachment described in further details below…”) (Par. 94, “the steering wires 14 and 16 steer the catheter 12 in a first plane”) (Par. 99, “The wheels 24, 26, 28 and 30 are rotated about the rotation axis by one of more actuators…” “… the actuators takes the form of knobs, such as the first and second knobs 34 and 36 provided outside of the actuating assembly body 22 are mounted thereto so as to be rotatable about the rotation axis 32.”) (Par. 100, “The actuating assembly 10 is configurable to an actuating configuration in which the first and second knobs 34 and 36 are operatively coupled respectively to the wheels 24 and 26 and to the wheels 28 and 30 so that the wheels 24 and 26 may be jointly rotated selectively clockwise or counter-clockwise by the first knob 34 and the wheels 28 and 30 may be jointly rotated selectively clockwise or counter-clockwise by the second knob 36.”) (Par. 100, “Such rotations will shorten the portion of one of the steering wires 14, 16, 18 and 20 that protrudes outside of the actuating assembly body 22 and lengthen the corresponding portion of the other steering wire 14, 16, 18 and 20 within a pair, which in turn will steers the catheter 12.”)).
Regarding claim 3, Kien further discloses wherein said control knob is rotatable to control a steering gear system operatively coupled with said first flexible elongate steering element and said second flexible elongate steering element to control movement of said steerable flexible elongate member (Par. 97, “Wheels 24, 26, 28 and 30 are mounted in the actuating assembly cavity 23 and each receive a respective one of the steering wires 14, 16, 18 and 20 that it is mounted or secured thereto, for example using a wire attachment described in further details below…”) (Par. 94, “the steering wires 14 and 16 steer the catheter 12 in a first plane”) (Par. 99, “The wheels 24, 26, 28 and 30 are rotated about the rotation axis by one of more actuators…” “… the actuators takes the form of knobs, such as the first and second knobs 34 and 36 provided outside of the actuating assembly body 22 are mounted thereto so as to be rotatable about the rotation axis 32.”) (Par. 100, “The actuating assembly 10 is configurable to an actuating configuration in which the first and second knobs 34 and 36 are operatively coupled respectively to the wheels 24 and 26 and to the wheels 28 and 30 so that the wheels 24 and 26 may be jointly rotated selectively clockwise or counter-clockwise by the first knob 34 and the wheels 28 and 30 may be jointly rotated selectively clockwise or counter-clockwise by the second knob 36.”) (Par. 100, “Such rotations will shorten the portion of one of the steering wires 14, 16, 18 and 20 that protrudes outside of the actuating assembly body 22 and lengthen the corresponding portion of the other steering wire 14, 16, 18 and 20 within a pair, which in turn will steers the catheter 12.”)) (Par. 103-104 (first knob – 34)) (Par. 116 (wheel with toothed faces 104 and 106)).
Regarding claim 6, Kien further discloses wherein:
said two-way steering system is a first two-way steering system operatively associated with said steerable flexible elongate member to steer said steerable flexible elongate member in a first steering plane (Fig. 14, actuating assembly – 10) (Fig. 14, knob -34) (Par. 94, “The steerable catheter 12 is provided with at least one pair of steering wires 14 and 16 reaching the actuating assembly 10…”) (Par. 94, “the steering wires 14 and 16 steer the catheter 12 in a first plane”) (Par. 97, “Wheels 24, 26, 28 and 30 are mounted in the actuating assembly cavity 23 and each receive a respective one of the steering wires 14, 16, 18 and 20 that it is mounted or secured thereto, for example using a wire attachment described in further details below…”) (Par. 99, “The wheels 24, 26, 28 and 30 are rotated about the rotation axis by one of more actuators…” “… the actuators takes the form of knobs, such as the first and second knobs 34 and 36 provided outside of the actuating assembly body 22 are mounted thereto so as to be rotatable about the rotation axis 32.”) (Par. 100, “The actuating assembly 10 is configurable to an actuating configuration in which the first and second knobs 34 and 36 are operatively coupled respectively to the wheels 24 and 26 and to the wheels 28 and 30 so that the wheels 24 and 26 may be jointly rotated selectively clockwise or counter-clockwise by the first knob 34 and the wheels 28 and 30 may be jointly rotated selectively clockwise or counter-clockwise by the second knob 36.”) (Par. 100, “Such rotations will shorten the portion of one of the steering wires 14, 16, 18 and 20 that protrudes outside of the actuating assembly body 22 and lengthen the corresponding portion of the other steering wire 14, 16, 18 and 20 within a pair, which in turn will steers the catheter 12.”)); and
said medical device delivery system further comprises a second two-way steering system operatively associated with said steerable flexible elongate member to steer said steerable flexible elongate member in a second steering plane transverse to said first steering plane (Fig. 14, knob – 36) (Par. 94, “while the steering wires 18 and 20 steer the catheter 12 in a second plane, which may be orthogonal to the first plane”) (Par. 97, “Wheels 24, 26, 28 and 30 are mounted in the actuating assembly cavity 23 and each receive a respective one of the steering wires 14, 16, 18 and 20 that it is mounted or secured thereto, for example using a wire attachment described in further details below…”) (Par. 99, “The wheels 24, 26, 28 and 30 are rotated about the rotation axis by one of more actuators…” “… the actuators takes the form of knobs, such as the first and second knobs 34 and 36 provided outside of the actuating assembly body 22 are mounted thereto so as to be rotatable about the rotation axis 32.”) (Par. 100, “The actuating assembly 10 is configurable to an actuating configuration in which the first and second knobs 34 and 36 are operatively coupled respectively to the wheels 24 and 26 and to the wheels 28 and 30 so that the wheels 24 and 26 may be jointly rotated selectively clockwise or counter-clockwise by the first knob 34 and the wheels 28 and 30 may be jointly rotated selectively clockwise or counter-clockwise by the second knob 36.”) (Par. 100, “Such rotations will shorten the portion of one of the steering wires 14, 16, 18 and 20 that protrudes outside of the actuating assembly body 22 and lengthen the corresponding portion of the other steering wire 14, 16, 18 and 20 within a pair, which in turn will steers the catheter 12.”)).
Regarding claim 15, Kien further discloses wherein said control knob steers the steerable flexible elongate member in a first steering plane (Fig. 14, knob -34) (Par. 94, “The steerable catheter 12 is provided with at least one pair of steering wires 14 and 16 reaching the actuating assembly 10…”) (Par. 94, “the steering wires 14 and 16 steer the catheter 12 in a first plane”) (Par. 97, “Wheels 24, 26, 28 and 30 are mounted in the actuating assembly cavity 23 and each receive a respective one of the steering wires 14, 16, 18 and 20 that it is mounted or secured thereto, for example using a wire attachment described in further details below…”) (Par. 99, “The wheels 24, 26, 28 and 30 are rotated about the rotation axis by one of more actuators…” “… the actuators takes the form of knobs, such as the first and second knobs 34 and 36 provided outside of the actuating assembly body 22 are mounted thereto so as to be rotatable about the rotation axis 32.”) (Par. 100, “The actuating assembly 10 is configurable to an actuating configuration in which the first and second knobs 34 and 36 are operatively coupled respectively to the wheels 24 and 26 and to the wheels 28 and 30 so that the wheels 24 and 26 may be jointly rotated selectively clockwise or counter-clockwise by the first knob 34 and the wheels 28 and 30 may be jointly rotated selectively clockwise or counter-clockwise by the second knob 36.”) (Par. 100, “Such rotations will shorten the portion of one of the steering wires 14, 16, 18 and 20 that protrudes outside of the actuating assembly body 22 and lengthen the corresponding portion of the other steering wire 14, 16, 18 and 20 within a pair, which in turn will steers the catheter 12.”)), said control handle further comprising a control knob (Fig. 14, knob – 36) mounted on said control handle housing and operatively associated with a third flexible elongate steering element (Fig. 14, wire – 18) and a fourth flexible elongate steering element (Fig. 14, wire – 20) to steer the steerable flexible elongate member in a second steering plane transverse to the first steering plane (Par. 94, “while the steering wires 18 and 20 steer the catheter 12 in a second plane, which may be orthogonal to the first plane”) (Par. 97, “Wheels 24, 26, 28 and 30 are mounted in the actuating assembly cavity 23 and each receive a respective one of the steering wires 14, 16, 18 and 20 that it is mounted or secured thereto, for example using a wire attachment described in further details below…”) (Par. 99, “The wheels 24, 26, 28 and 30 are rotated about the rotation axis by one of more actuators…” “… the actuators takes the form of knobs, such as the first and second knobs 34 and 36 provided outside of the actuating assembly body 22 are mounted thereto so as to be rotatable about the rotation axis 32.”) (Par. 100, “The actuating assembly 10 is configurable to an actuating configuration in which the first and second knobs 34 and 36 are operatively coupled respectively to the wheels 24 and 26 and to the wheels 28 and 30 so that the wheels 24 and 26 may be jointly rotated selectively clockwise or counter-clockwise by the first knob 34 and the wheels 28 and 30 may be jointly rotated selectively clockwise or counter-clockwise by the second knob 36.”) (Par. 100, “Such rotations will shorten the portion of one of the steering wires 14, 16, 18 and 20 that protrudes outside of the actuating assembly body 22 and lengthen the corresponding portion of the other steering wire 14, 16, 18 and 20 within a pair, which in turn will steers the catheter 12.”)).
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.
Claim(s) 4, 10, and 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kien as applied to claim 3, 6, and 11 above, and further in view of Root (US Pub. No. 20040193016) hereinafter Root.
Kien discloses the system of claim 3 above.
Regarding claim 4, Kien fails to explicitly disclose the limitations of the claim.
However, Kien does disclose wherein:
said steering gear system comprises a control knob assembly (Kien (Par. 107, (first axle – 38 of first knob - 34))) operatively coupled with a steering gear pulley assembly (Kien (Par. 110, (first and second wheels 24 and 26)) (Par. 107, “the first axle 38 extends integrally from the first knob 34 and defines successive first axle mounting, locking, wheel receiving and lock ring mounting sections 48, 50, 52 and 54, in a direction leading away from the first knob 34”) (Par. 110, “The first axle wheel receiving section 52 is configured for receiving the first and second wheels 24 and 26 thereonto so that the first and second wheels 24 and 26 are slidable and rotatable relative…”) (Par. 118, “The axle teeth 64 and the axle engaging teeth 108 engage each other in the first wheel actuating configuration to force joint rotation about the rotation axis 32 of the first axle 38 and first wheel 24. The axle teeth 64 and axle engaging teeth 108 are disengaged from each other in the first wheel mounting configuration to allow rotation about the rotation axis 32 of the first wheel 24 independently from the first axle 38…”)(Par. 100, “The actuating assembly 10 is configurable to an actuating configuration in which the first and second knobs 34 and 36 are operatively coupled respectively to the wheels 24 and 26 and to the wheels 28 and 30 so that the wheels 24 and 26 may be jointly rotated selectively clockwise or counter-clockwise by the first knob 34 and the wheels 28 and 30 may be jointly rotated selectively clockwise or counter-clockwise by the second knob 36.”));
said control knob is operatively coupled with said control knob assembly to control rotational movement of said control knob assembly (Kien (Par. 107, “the first axle 38 extends integrally from the first knob 34 and defines successive first axle mounting, locking, wheel receiving and lock ring mounting sections 48, 50, 52 and 54, in a direction leading away from the first knob 34”) (Par. 110, “The first axle wheel receiving section 52 is configured for receiving the first and second wheels 24 and 26 thereonto so that the first and second wheels 24 and 26 are slidable and rotatable relative…”) (Par. 118, “The axle teeth 64 and the axle engaging teeth 108 engage each other in the first wheel actuating configuration to force joint rotation about the rotation axis 32 of the first axle 38 and first wheel 24”) (Par. 117, “the first wheel first toothed face 104 engages the first axle toothed face 62 so that these first axle 38 and the first wheel 24 are jointly axially rotatable. Also, the first wheel second toothed face 106 engages the second wheel toothed face 112 so that the first and second wheels 24 and 26 are jointly axially rotatable”) (Par. 100, “The actuating assembly 10 is configurable to an actuating configuration in which the first and second knobs 34 and 36 are operatively coupled respectively to the wheels 24 and 26 and to the wheels 28 and 30 so that the wheels 24 and 26 may be jointly rotated selectively clockwise or counter-clockwise by the first knob 34 and the wheels 28 and 30 may be jointly rotated selectively clockwise or counter-clockwise by the second knob 36.”)); and
said steering gear pulley assembly is operatively coupled with said first flexible elongate steering element and said second flexible elongate steering element to control movement thereof to steer said steerable flexible elongate member (Kien (Par. 97, “Wheels 24, 26, 28 and 30 are mounted in the actuating assembly cavity 23 and each receive a respective one of the steering wires 14, 16, 18 and 20 that it is mounted or secured thereto, for example using a wire attachment described in further details below…”) (Par. 94, “the steering wires 14 and 16 steer the catheter 12 in a first plane”) (Par. 99, “The wheels 24, 26, 28 and 30 are rotated about the rotation axis by one of more actuators…” “… the actuators takes the form of knobs, such as the first and second knobs 34 and 36 provided outside of the actuating assembly body 22 are mounted thereto so as to be rotatable about the rotation axis 32.”) (Par. 100, “The actuating assembly 10 is configurable to an actuating configuration in which the first and second knobs 34 and 36 are operatively coupled respectively to the wheels 24 and 26 and to the wheels 28 and 30 so that the wheels 24 and 26 may be jointly rotated selectively clockwise or counter-clockwise by the first knob 34 and the wheels 28 and 30 may be jointly rotated selectively clockwise or counter-clockwise by the second knob 36.”) (Par. 102, “assembly of one or more steering wires 14, 16, 18 and 20 to one or more wheels 24, 26, 28 and 30 and to allow steering the catheter 12 once assembly has been completed”)).
Root teaches a pinion assembly (Par. 39, “articulation wire may be pulled by a rack and pinion system, cam drive, planetary gear system, etc., determined by the force and travel required by the application.”) (Par. 41, “using a planetary gear or rack and pinion mechanism.”) (Par. 6, “he movement of the direction of the distal tip of a remote imaging device, commonly referred to as articulation, is most often accomplished by pushing and/or pulling wires attached between the distal tip of the endoscope and a gear system in the proximal handle. Gears (e.g., capstans, rack and pinion, cams) within the handle are moved by the operator using levers or wheels connected to the gears.”).
Kien and Root are considered to be analogous art to the claimed invention as they are involved with devices for insertion into body cavities.
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the system of Kien with that of Root to include wherein: said steering gear system comprises a control knob pinion assembly operatively coupled with a steering gear pulley assembly; said control knob is operatively coupled with said control knob pinion assembly to control rotational movement of said control knob pinion assembly; and said steering gear pulley assembly is operatively coupled with said first flexible elongate steering element and said second flexible elongate steering element to control movement thereof to steer said steerable flexible elongate member through the combination of references and substitution of wire pulling structures as differing wire pulling structures are known in the art (Root (Par. 39)) and it would have yielded the same or similar result of controlling the movement of the catheter.
Kien discloses the system of claim 6 above.
Regarding claim 10, Kien further discloses further comprising a first control knob operatively associated said first two-way steering system via a first steering gear system (Fig. 14, knob -34) (Par. 94, “The steerable catheter 12 is provided with at least one pair of steering wires 14 and 16 reaching the actuating assembly 10…”) (Par. 94, “the steering wires 14 and 16 steer the catheter 12 in a first plane”) (Par. 97, “Wheels 24, 26, 28 and 30 are mounted in the actuating assembly cavity 23 and each receive a respective one of the steering wires 14, 16, 18 and 20 that it is mounted or secured thereto, for example using a wire attachment described in further details below…”) (Par. 99, “The wheels 24, 26, 28 and 30 are rotated about the rotation axis by one of more actuators…” “… the actuators takes the form of knobs, such as the first and second knobs 34 and 36 provided outside of the actuating assembly body 22 are mounted thereto so as to be rotatable about the rotation axis 32.”) (Par. 100, “The actuating assembly 10 is configurable to an actuating configuration in which the first and second knobs 34 and 36....”) (Par. 100, “Such rotations will shorten the portion of one of the steering wires 14, 16, 18 and 20 that protrudes outside of the actuating assembly body 22 and lengthen the corresponding portion of the other steering wire 14, 16, 18 and 20 within a pair, which in turn will steers the catheter 12.”)), and
a second control knob operatively associated said second two-way steering system via a second steering gear system (Fig. 14, knob – 36) (Par. 94, “while the steering wires 18 and 20 steer the catheter 12 in a second plane, which may be orthogonal to the first plane”) (Par. 97, “Wheels 24, 26, 28 and 30 are mounted in the actuating assembly cavity 23 and each receive a respective one of the steering wires 14, 16, 18 and 20 that it is mounted or secured thereto, for example using a wire attachment described in further details below…”) (Par. 99, “The wheels 24, 26, 28 and 30 are rotated about the rotation axis by one of more actuators…” “… the actuators takes the form of knobs, such as the first and second knobs 34 and 36 provided outside of the actuating assembly body 22 are mounted thereto so as to be rotatable about the rotation axis 32.”) (Par. 100, “The actuating assembly 10 is configurable to an actuating configuration in which the first and second knobs 34 and 36 are operatively coupled respectively to the wheels 24 and 26 and to the wheels 28 and 30....”) (Par. 100, “Such rotations will shorten the portion of one of the steering wires 14, 16, 18 and 20 that protrudes outside of the actuating assembly body 22 and lengthen the corresponding portion of the other steering wire 14, 16, 18 and 20 within a pair, which in turn will steers the catheter 12.”)),
wherein gears of said first steering gear system rotate about respective first gear system axes parallel to one another (Kien (Par. 107, “the first axle 38 extends integrally from the first knob 34 and defines successive first axle mounting, locking, wheel receiving and lock ring mounting sections 48, 50, 52 and 54, in a direction leading away from the first knob 34”) (Par. 110, “The first axle wheel receiving section 52 is configured for receiving the first and second wheels 24 and 26 thereonto so that the first and second wheels 24 and 26 are slidable and rotatable relative…”) (Par. 118, “The axle teeth 64 and the axle engaging teeth 108 engage each other in the first wheel actuating configuration to force joint rotation about the rotation axis 32 of the first axle 38 and first wheel 24”) (Par. 117, “the first wheel first toothed face 104 engages the first axle toothed face 62 so that these first axle 38 and the first wheel 24 are jointly axially rotatable. Also, the first wheel second toothed face 106 engages the second wheel toothed face 112 so that the first and second wheels 24 and 26 are jointly axially rotatable”) (Par. 100, “The actuating assembly 10 is configurable to an actuating configuration in which the first and second knobs 34 and 36 are operatively coupled respectively to the wheels 24 and 26 and to the wheels 28 and 30 so that the wheels 24 and 26 may be jointly rotated selectively clockwise or counter-clockwise by the first knob 34 and the wheels 28 and 30 may be jointly rotated selectively clockwise or counter-clockwise by the second knob 36.”)).
Kien fails to explicitly disclose gears of said second steering gear system rotate about respective second gear system axes parallel to one another and transverse to said first gear system axes.
Kien does disclose gears of said second steering gear system rotate about respective second gear system axes parallel to one another (Kien (Par. 114, “The second axle mounting, locking, wheel receiving and lock ring mounting sections 72, 74, 76 and 78 are similar to the first axle mounting, locking, wheel receiving and lock ring mounting sections 48, 50, 52 and 54 and are therefore not further described...”) (Par. 115, “FIG. 16 illustrates the first and second wheels 24 and 26, the third and fourth wheels 28 and 30 being similar respectively to the second and first wheels 26 and 24, and therefore not further described herein…”) (Par. 112-113, “Referring for example to FIG. 12, the second axle 40 defines a second axle link 68 extending from the second knob 36, for example integrally therewith, and a second axle effective portion 70 removably attachable to the second axle link 68…”)(Par. 118, “The axle teeth 64 and the axle engaging teeth 108 engage each other in the first wheel actuating configuration to force joint rotation about the rotation axis 32 of the first axle 38 and first wheel 24”) (Par. 117, “the first wheel first toothed face 104 engages the first axle toothed face 62 so that these first axle 38 and the first wheel 24 are jointly axially rotatable. Also, the first wheel second toothed face 106 engages the second wheel toothed face 112 so that the first and second wheels 24 and 26 are jointly axially rotatable”)) and to said first gear system axes (Kien (Par. 118, “The axle teeth 64 and the axle engaging teeth 108 engage each other in the first wheel actuating configuration to force joint rotation about the rotation axis 32 of the first axle 38 and first wheel 24”) (Par. 117, “the first wheel first toothed face 104 engages the first axle toothed face 62 so that these first axle 38 and the first wheel 24 are jointly axially rotatable. Also, the first wheel second toothed face 106 engages the second wheel toothed face 112 so that the first and second wheels 24 and 26 are jointly axially rotatable”) (Par. 114, “The second axle mounting, locking, wheel receiving and lock ring mounting sections 72, 74, 76 and 78 are similar to the first axle mounting, locking, wheel receiving and lock ring mounting sections 48, 50, 52 and 54 and are therefore not further described...”) (Par. 115, “FIG. 16 illustrates the first and second wheels 24 and 26, the third and fourth wheels 28 and 30 being similar respectively to the second and first wheels 26 and 24, and therefore not further described herein…”) (Par. 114, “the second axle mounting, locking, wheel receiving and lock ring mounting sections 72, 74, 76 and 78 are a mirror image along the rotation axis 32 of the first axle mounting, locking, wheel receiving and lock ring mounting sections 48, 50, 52 and 54…”)).
Root teaches differing orientations of drums (Par. 45, “FIGS. 4 through 7 show other possible configurations for the inventive mechanism. FIG. 4 shows directly intermeshed gears 170a and 172a, with drum 180 coupled to gear 172a. FIG. 5 is very similar, but with intermeshed gears 170b and 172a inside of rather than outside of drums 130b and 180b. FIG. 6 shows a configuration in which the drums 130c and 180c are together. FIG. 7 shows a configuration in which drums 130d and 180d are in different planes. In this embodiment, the second gear 172d can be integral with drum 180d.”).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the system of Kien with that of Root to include gears of said second steering gear system rotate about respective second gear system axes parallel to one another and transverse to said first gear system axes through the combination of references as differing design variations are known (Root (Par. 45)) and it would have yielded the same or similar results.
Kien discloses the device of claim 11 above.
Regarding claim 13, Kien fails to explicitly disclose the limitations of the claim.
However, Kien does disclose a gear system comprising a control knob assembly (Kien (Par. 107, first axle – 38)) operatively associated with said control knob (Kien (Par. 110, (first and second wheels 24 and 26)) (Par. 107, “the first axle 38 extends integrally from the first knob 34 and defines successive first axle mounting, locking, wheel receiving and lock ring mounting sections 48, 50, 52 and 54, in a direction leading away from the first knob 34”) (Par. 110, “The first axle wheel receiving section 52 is configured for receiving the first and second wheels 24 and 26 thereonto so that the first and second wheels 24 and 26 are slidable and rotatable relative…”) (Par. 118, “The axle teeth 64 and the axle engaging teeth 108 engage each other in the first wheel actuating configuration to force joint rotation about the rotation axis 32 of the first axle 38 and first wheel 24. The axle teeth 64 and axle engaging teeth 108 are disengaged from each other in the first wheel mounting configuration to allow rotation about the rotation axis 32 of the first wheel 24 independently from the first axle 38…”)(Par. 100, “The actuating assembly 10 is configurable to an actuating configuration in which the first and second knobs 34 and 36 are operatively coupled respectively to the wheels 24 and 26 and to the wheels 28 and 30 so that the wheels 24 and 26 may be jointly rotated selectively clockwise or counter-clockwise by the first knob 34 and the wheels 28 and 30 may be jointly rotated selectively clockwise or counter-clockwise by the second knob 36.”)), and
a steering gear pulley assembly operatively associated with the control knob and with the first flexible elongate steering element and the second flexible elongate steering element (Kien (Par. 97, “Wheels 24, 26, 28 and 30 are mounted in the actuating assembly cavity 23 and each receive a respective one of the steering wires 14, 16, 18 and 20 that it is mounted or secured thereto, for example using a wire attachment described in further details below…”) (Par. 94, “the steering wires 14 and 16 steer the catheter 12 in a first plane”) (Par. 99, “The wheels 24, 26, 28 and 30 are rotated about the rotation axis by one of more actuators…” “… the actuators takes the form of knobs, such as the first and second knobs 34 and 36 provided outside of the actuating assembly body 22 are mounted thereto so as to be rotatable about the rotation axis 32.”) (Par. 100, “The actuating assembly 10 is configurable to an actuating configuration in which the first and second knobs 34 and 36 are operatively coupled respectively to the wheels 24 and 26 and to the wheels 28 and 30 so that the wheels 24 and 26 may be jointly rotated selectively clockwise or counter-clockwise by the first knob 34 and the wheels 28 and 30 may be jointly rotated selectively clockwise or counter-clockwise by the second knob 36.”) (Par. 102, “assembly of one or more steering wires 14, 16, 18 and 20 to one or more wheels 24, 26, 28 and 30 and to allow steering the catheter 12 once assembly has been completed”)),
wherein rotation of said control knob operates said gear system to control steering of the steerable flexible elongate member (Kien (Par. 107, “the first axle 38 extends integrally from the first knob 34 and defines successive first axle mounting, locking, wheel receiving and lock ring mounting sections 48, 50, 52 and 54, in a direction leading away from the first knob 34”) (Par. 110, “The first axle wheel receiving section 52 is configured for receiving the first and second wheels 24 and 26 thereonto so that the first and second wheels 24 and 26 are slidable and rotatable relative…”) (Par. 118, “The axle teeth 64 and the axle engaging teeth 108 engage each other in the first wheel actuating configuration to force joint rotation about the rotation axis 32 of the first axle 38 and first wheel 24”) (Par. 117, “the first wheel first toothed face 104 engages the first axle toothed face 62 so that these first axle 38 and the first wheel 24 are jointly axially rotatable. Also, the first wheel second toothed face 106 engages the second wheel toothed face 112 so that the first and second wheels 24 and 26 are jointly axially rotatable”) (Par. 100, “The actuating assembly 10 is configurable to an actuating configuration in which the first and second knobs 34 and 36 are operatively coupled respectively to the wheels 24 and 26 and to the wheels 28 and 30 so that the wheels 24 and 26 may be jointly rotated selectively clockwise or counter-clockwise by the first knob 34 and the wheels 28 and 30 may be jointly rotated selectively clockwise or counter-clockwise by the second knob 36.”)).
Root teaches a pinion assembly (Par. 39, “articulation wire may be pulled by a rack and pinion system, cam drive, planetary gear system, etc., determined by the force and travel required by the application.”) (Par. 41, “using a planetary gear or rack and pinion mechanism.”) (Par. 6, “he movement of the direction of the distal tip of a remote imaging device, commonly referred to as articulation, is most often accomplished by pushing and/or pulling wires attached between the distal tip of the endoscope and a gear system in the proximal handle. Gears (e.g., capstans, rack and pinion, cams) within the handle are moved by the operator using levers or wheels connected to the gears.”)
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Kien with that of Root to include a gear system comprising a control knob pinion assembly operatively associated with said control knob, and a steering gear pulley assembly operatively associated with the control knob pinion assembly and with the first flexible elongate steering element and the second flexible elongate steering element, wherein rotation of said control knob operates said gear system to control steering of the steerable flexible elongate member through the combination of references and substitution of wire pulling structures as differing wire pulling structures are known in the art (Root (Par. 39)) and it would have yielded the same or similar result of controlling the movement of the catheter.
Regarding claim 14, modified Kien further discloses said steering gear pulley assembly comprises a first steering gear pulley assembly operatively associated with the first flexible elongate steering element (Kien(Fig. 14, wheel – 24, wire – 14) (Par. 97, “Wheels 24, 26, 28 and 30 are mounted in the actuating assembly cavity 23 and each receive a respective one of the steering wires 14, 16, 18 and 20 that it is mounted or secured thereto, for example using a wire attachment described in further details below…”) (Par. 94, “the steering wires 14 and 16 steer the catheter 12 in a first plane”) (Par. 99, “The wheels 24, 26, 28 and 30 are rotated about the rotation axis by one of more actuators…” “… the actuators takes the form of knobs, such as the first and second knobs 34 and 36 provided outside of the actuating assembly body 22 are mounted thereto so as to be rotatable about the rotation axis 32.”) (Par. 100, “The actuating assembly 10 is configurable to an actuating configuration in which the first and second knobs 34 and 36 are operatively coupled respectively to the wheels 24 and 26 and to the wheels 28 and 30 so that the wheels 24 and 26 may be jointly rotated selectively clockwise or counter-clockwise by the first knob 34 and the wheels 28 and 30 may be jointly rotated selectively clockwise or counter-clockwise by the second knob 36.”) (Par. 102, “assembly of one or more steering wires 14, 16, 18 and 20 to one or more wheels 24, 26, 28 and 30 and to allow steering the catheter 12 once assembly has been completed”)),
and a second steering gear pulley assembly operatively associated with the second flexible elongate steering element (Kien(Fig. 14, wheel – 26, wire – 16) (Par. 97, “Wheels 24, 26, 28 and 30 are mounted in the actuating assembly cavity 23 and each receive a respective one of the steering wires 14, 16, 18 and 20 that it is mounted or secured thereto, for example using a wire attachment described in further details below…”) (Par. 94, “the steering wires 14 and 16 steer the catheter 12 in a first plane”) (Par. 99, “The wheels 24, 26, 28 and 30 are rotated about the rotation axis by one of more actuators…” “… the actuators takes the form of knobs, such as the first and second knobs 34 and 36 provided outside of the actuating assembly body 22 are mounted thereto so as to be rotatable about the rotation axis 32.”) (Par. 100, “The actuating assembly 10 is configurable to an actuating configuration in which the first and second knobs 34 and 36 are operatively coupled respectively to the wheels 24 and 26 and to the wheels 28 and 30 so that the wheels 24 and 26 may be jointly rotated selectively clockwise or counter-clockwise by the first knob 34 and the wheels 28 and 30 may be jointly rotated selectively clockwise or counter-clockwise by the second knob 36.”) (Par. 102, “assembly of one or more steering wires 14, 16, 18 and 20 to one or more wheels 24, 26, 28 and 30 and to allow steering the catheter 12 once assembly has been completed”)); and
at least one of said steering gear pulley assemblies comprises a gear with a gear barrel extending therefrom and configured for coupling a flexible elongate steering element thereto (Kien (Par. 97, “Wheels 24, 26, 28 and 30 are mounted in the actuating assembly cavity 23 and each receive a respective one of the steering wires 14, 16, 18 and 20 that it is mounted or secured thereto…”)(Par. 110, (first and second wheels 24 and 26)) (Par. 107, “the first axle 38 extends integrally from the first knob 34 and defines successive first axle mounting, locking, wheel receiving and lock ring mounting sections 48, 50, 52 and 54, in a direction leading away from the first knob 34”) (Par. 110, “The first axle wheel receiving section 52 is configured for receiving the first and second wheels 24 and 26 thereonto so that the first and second wheels 24 and 26 are slidable and rotatable relative…”) (Par. 118, “The axle teeth 64 and the axle engaging teeth 108 engage each other in the first wheel actuating configuration to force joint rotation about the rotation axis 32 of the first axle 38 and first wheel 24. The axle teeth 64 and axle engaging teeth 108 are disengaged from each other in the first wheel mounting configuration to allow rotation about the rotation axis 32 of the first wheel 24 independently from the first axle 38…”)(Par. 100, “The actuating assembly 10 is configurable to an actuating configuration in which the first and second knobs 34 and 36 are operatively coupled respectively to the wheels 24 and 26 and to the wheels 28 and 30 so that the wheels 24 and 26 may be jointly rotated selectively clockwise or counter-clockwise by the first knob 34 and the wheels 28 and 30 may be jointly rotated selectively clockwise or counter-clockwise by the second knob 36.”))), the steering gear pulley assembly configured to maintain the position of the flexible elongate steering element on the gear barrel without being entangled with the gear (Kien (Par. 97, “The steering wires 14, 16, 18 and 20 are mounted to the wheels 24, 26, 28 and 30 so that the steering wires 14, 16, 18 and 20 within a pair steering the catheter 12 in a given plane are wound about respective paired wheels 24, 26, 28 and 30 in opposite directions.”)(Par. 110, “The first axle wheel receiving section 52 is configured for receiving the first and second wheels 24 and 26 thereonto so that the first and second wheels 24 and 26 are slidable and rotatable relative…”) (Par. 118, “The axle teeth 64 and the axle engaging teeth 108 engage each other in the first wheel actuating configuration to force joint rotation about the rotation axis 32 of the first axle 38 and first wheel 24. The axle teeth 64 and axle engaging teeth 108 are disengaged from each other in the first wheel mounting configuration to allow rotation about the rotation axis 32 of the first wheel 24 independently from the first axle 38…”)).
Claim(s) 5 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kien as applied to claim above, and further in view of Romoscanu (US Pat. No. 9174024) hereinafter Romoscanu.
Kien discloses the system of claim 2 above.
Regarding claim 5, Kien further discloses wherein said control knob comprises a directional control knob element controlling movement of said first flexible elongate steering element and said second flexible elongate steering element (Kien (Fig. 14, knob -34) (Par. 97, “Wheels 24, 26, 28 and 30 are mounted in the actuating assembly cavity 23 and each receive a respective one of the steering wires 14, 16, 18 and 20 that it is mounted or secured thereto, for example using a wire attachment described in further details below…”) (Par. 94, “the steering wires 14 and 16 steer the catheter 12 in a first plane”) (Par. 99, “The wheels 24, 26, 28 and 30 are rotated about the rotation axis by one of more actuators…” “… the actuators takes the form of knobs, such as the first and second knobs 34 and 36 provided outside of the actuating assembly body 22 are mounted thereto so as to be rotatable about the rotation axis 32.”) (Par. 100, “The actuating assembly 10 is configurable to an actuating configuration in which the first and second knobs 34 and 36 are operatively coupled respectively to the wheels 24 and 26 and to the wheels 28 and 30 so that the wheels 24 and 26 may be jointly rotated selectively clockwise or counter-clockwise by the first knob 34 and the wheels 28 and 30 may be jointly rotated selectively clockwise or counter-clockwise by the second knob 36.”) (Par. 100, “Such rotations will shorten the portion of one of the steering wires 14, 16, 18 and 20 that protrudes outside of the actuating assembly body 22 and lengthen the corresponding portion of the other steering wire 14, 16, 18 and 20 within a pair, which in turn will steers the catheter 12.”)).
----Kien fails to explicitly disclose a friction control knob element controlling movement of said directional control knob element.
However, Romoscanu teaches a friction control knob element (Adjustment knob – 52) (Col. 5-6, lines 66-4, “A friction adjustment mechanism 50 can also be operatively coupled to the cam 44. The friction adjustment mechanism includes an adjustment knob 52 threadably engaged with a collar 54 that disposed within the cam 44. A biasing element 56, such as a wave washer or spring washer, is disposed between the collar 54 and the housing 42.”) controlling movement of said directional control knob element (Fig. 2, cam – 44) (Col. 6, lines 5-15, “cam 44 is rotated in either direction about a rotation axis 66. The thumb knobs 46 and 48, being of different profiles, have different tactile qualities, so that the operator can tell which knob is in contact with his or her thumb without looking at the handle. The adjustment knob 52 can be rotated to adjust the compression exerted by the collar 54 on the biasing element 56. The frictional resistance to the rotation of the cam 44 can be governed primarily by the friction between the collar 54 and the biasing element 56. In this way, the friction associated with rotating the cam 44 can be adjusted according to the preference of the operator”).
Kien and Romoscanu are considered to be analogous art to the claimed invention as they are involved with devices for insertion into body cavities.
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the system of Kien with that of Romoscanu to include a friction control knob element controlling movement of said directional control knob element of Kien through the combination of references as it would have yielded the predictable result of allowing for a user to adjust the frictional resistance of the device to a desired level (Romoscanu (Col. 5-6, lines 66-15)).
Kien discloses the device of claim 11 above.
Regarding claim 12, Kien further discloses wherein said control knob comprises a directional control knob element controlling movement of the first flexible elongate steering element and the second flexible elongate steering element (Kien (Fig. 14, knob -34) (Par. 97, “Wheels 24, 26, 28 and 30 are mounted in the actuating assembly cavity 23 and each receive a respective one of the steering wires 14, 16, 18 and 20 that it is mounted or secured thereto, for example using a wire attachment described in further details below…”) (Par. 94, “the steering wires 14 and 16 steer the catheter 12 in a first plane”) (Par. 99, “The wheels 24, 26, 28 and 30 are rotated about the rotation axis by one of more actuators…” “… the actuators takes the form of knobs, such as the first and second knobs 34 and 36 provided outside of the actuating assembly body 22 are mounted thereto so as to be rotatable about the rotation axis 32.”) (Par. 100, “The actuating assembly 10 is configurable to an actuating configuration in which the first and second knobs 34 and 36 are operatively coupled respectively to the wheels 24 and 26 and to the wheels 28 and 30 so that the wheels 24 and 26 may be jointly rotated selectively clockwise or counter-clockwise by the first knob 34 and the wheels 28 and 30 may be jointly rotated selectively clockwise or counter-clockwise by the second knob 36.”) (Par. 100, “Such rotations will shorten the portion of one of the steering wires 14, 16, 18 and 20 that protrudes outside of the actuating assembly body 22 and lengthen the corresponding portion of the other steering wire 14, 16, 18 and 20 within a pair, which in turn will steers the catheter 12.”)).
----Kien fails to explicitly disclose a friction control knob element controlling movement of said directional control knob element.
However, Romoscanu teaches a friction control knob element (Adjustment knob – 52) (Col. 5-6, lines 66-4, “A friction adjustment mechanism 50 can also be operatively coupled to the cam 44. The friction adjustment mechanism includes an adjustment knob 52 threadably engaged with a collar 54 that disposed within the cam 44. A biasing element 56, such as a wave washer or spring washer, is disposed between the collar 54 and the housing 42.”) controlling movement of said directional control knob element (Fig. 2, cam – 44) (Col. 6, lines 5-15, “cam 44 is rotated in either direction about a rotation axis 66. The thumb knobs 46 and 48, being of different profiles, have different tactile qualities, so that the operator can tell which knob is in contact with his or her thumb without looking at the handle. The adjustment knob 52 can be rotated to adjust the compression exerted by the collar 54 on the biasing element 56. The frictional resistance to the rotation of the cam 44 can be governed primarily by the friction between the collar 54 and the biasing element 56. In this way, the friction associated with rotating the cam 44 can be adjusted according to the preference of the operator”).
Kien and Romoscanu are considered to be analogous art to the claimed invention as they are involved with devices for insertion into body cavities.
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Kien with that of Romoscanu to include a friction control knob element controlling movement of said directional control knob element of Kien through the combination of references as it would have yielded the predictable result of allowing for a user to adjust the frictional resistance of the device to a desired level (Romoscanu (Col. 5-6, lines 66-15)).
Claim(s) 7-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kien as applied to claim 6 above, and further in view of Kien.
Kien discloses the system of claim 6 above.
Regarding claim 7, Kien fails to explicitly disclose the limitations of the claim.
However, Kien does teach in an alternate embodiment a steerable flexible tubular elongate member (Fig. 46-48, Par. 137, (unlabeled inner catheter)); and
a two-way steering system operatively associated with said steerable flexible tubular elongate member to steer said steerable flexible tubular elongate member in a steering plane (Fig. 46-48, actuating assembly – 10l) (Par. 137, “actuating assemblies 10k and 10l, may be cascaded, so that an inner catheter, provided inside an outer catheter, or a sheath, may be steered independently from the outer catheter, to add additional controlled degrees of freedom.”); wherein said steerable flexible elongate member extends through said steerable flexible tubular elongate member (Fig. 46-48, Par. 137, “so that an inner catheter, provided inside an outer catheter, or a sheath, may be steered independently from the outer catheter, to add additional controlled degrees of freedom.” (inner catheter inside of outer catheter)). Therefore, it would have been obvious to a person of ordinary skill in the art to modify the system of Kien with an alternate embodiment of Kien to include a steerable flexible tubular elongate member; and a two-way steering system operatively associated with said steerable flexible tubular elongate member to steer said steerable flexible tubular elongate member in a steering plane; wherein said steerable flexible elongate member extends through said steerable flexible tubular elongate member through the combination of embodiments as it would have yielded the predictable result of providing additional degrees of freedom (Kien (Par. 137)).
Regarding claim 8, modified Kien fails to explicitly disclose the limitations of the claim.
However, Kien does teach in an alternate embodiment wherein said steerable flexible elongate member is longitudinally translatable within said steerable flexible tubular elongate member (Fig. 46-48, Par. 137, “so that an inner catheter, provided inside an outer catheter, or a sheath, may be steered independently from the outer catheter, to add additional controlled degrees of freedom.”(inner catheter steered independently inside of outer catheter)).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the system of Kien with an alternate embodiment of Kien to include wherein said steerable flexible elongate member is longitudinally translatable within said steerable flexible tubular elongate member for the reasoning as indicated in claim 7 above.
Regarding claim 9, modified Kien fails to explicitly disclose the limitations of the claim.
However, Kien does teach in an alternate embodiment wherein said two-way steering system operatively associated with said steerable flexible tubular elongate member is rotatable relative to said steering system operatively associated with said steerable flexible elongate member to adjust the orientation of the steering plane in which said steerable flexible tubular elongate member is steered (Fig. 46-48, actuating assembly – 10l) (Par. 137, “actuating assemblies 10k and 10l, may be cascaded, so that an inner catheter, provided inside an outer catheter, or a sheath, may be steered independently from the outer catheter, to add additional controlled degrees of freedom.”).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the system of Kien with an alternate embodiment of Kien to include wherein said two-way steering system operatively associated with said steerable flexible tubular elongate member is rotatable relative to said steering system operatively associated with said steerable flexible elongate member to adjust the orientation of the steering plane in which said steerable flexible tubular elongate member is steered for the reasoning as indicated in claim 7 above.
Conclusion
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/ARI S PADDA/Examiner, Art Unit 3791
/ADAM J EISEMAN/Primary Examiner, Art Unit 3791
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