DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendment filed 02/27/2026 has been entered. Claims 1, 4-8, 10, 18-19, 21-22, 24, 26, 29-30, 34-35, 38, 39, and 43 are currently pending within the application. Claims 2-3, 9, 11-17, 20, 23, 25, 27-28, 31-33, 36-37, 40-42, and 44-45 have been canceled. Claims 1, 22, and 43 have been amended.
Response to Arguments
Applicant’s arguments filed 02/27/2026, with respect to the pending claims have been fully considered. Applicant has amended the independent claims with the newly added limitation stating, “wherein the sheath defines a working lumen extending between the leading edge and the second end of the sheath, wherein the working lumen is open in both the extended position and the retracted position, and wherein the working lumen and the second lumen collectively define a channel.” Such newly added limitation changes the scope of the claims and renders the previous rejection moot. Therefore the rejections identified in the non-final office action dated 12/02/2025, have been withdrawn.
However, upon further consideration, a new ground of rejections are made below. Please see the rejections under 35 U.S.C §103 below for further explanation.
Furthermore:
Applicant Argues: the claimed “linear motion mechanism,” and “second linear motion mechanism” are definite structural components that should not be considered under 35 U.S.C. §112(f) because MPEP §2181 states, “A claim limitation is presumed to invoke 35 U.S.C. §112f when it explicitly uses the term ‘means’ or ‘step’ and included functional language,” and claims 18 and 30 fails to the use the terms ‘means’ or ‘step’, on page 13 of Applicant remarks dated 02/27/2026.
Examiner Disagrees: The terms “linear motion mechanism,” and “second linear motion mechanism” are not definite structural components and should be considered under 35 U.S.C. §112(f). While Examiner agrees MPEP §2181 states, “A claim limitation is presumed to invoke 35 U.S.C. §112f when it explicitly uses the term ‘means’ or ‘step’ and included functional language,” MPEP §2181 also states, “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.”
Here claims 18 and 30 fail to use the terms ‘means’ or ‘step’ and also fail to provide sufficient structure within the claim language that is capable of performing the recited functions within the claims.
As previously stated, in the non-final office action dated 12/02/2025:
MPEP 2181. I. requires “…examiners [to] apply 35 U.S.C. 112(f) to a claim limitation if it meets the following 3-prong analysis:
(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.
Here Applicant’s claim 18 states, “a linear motion mechanism configured to translate the inner tube within the first lumen of the outer tube in the direction towards the first end of the outer tube from the first position to the second position.” The term “mechanism,” is a non-structural term having no specific structural meaning cited within claim 18. The term “linear motion,” fails to add structure to the term “mechanism,” See MPEP 2181(I)(A). The term “configured to” modifies the limited term ‘linear motion mechanism.’ The limitation “to translate the inner tube within the first lumen of the outer tube in the direction towards the first end of the outer tube from the first position to the second position” is functional language describing how the ‘linear motion mechanism’ functions. "Sufficient structure exists when the claim language specifies the exact structure that performs the function in question without need to resort to other portions of the specification or extrinsic evidence for an adequate understanding of the structure." [emphasis added] ; see also Altiris, Inc. v. Symantec Corp., 318 F.3d 1363, 1376, 65 USPQ2d 1865, 1874 (Fed. Cir. 2003). There are no other limitations within claim 18 describing the structure of the term ‘linear motion mechanism.’ Therefore, the claim limitation “linear motion mechanism” does meet the 3-prong analysis and should be interpreted under 35 U.S.C §112(f).
Here Applicant’s claim 30 states, “a second linear motion mechanism configured to translate the elongated member within the working lumen of the introducer device in the direction towards the leading edge of the sheath.” The term “mechanism,” is a non-structural term having no specific structural meaning cited within claim 30. The terms “second linear motion,” fails to add structure to the term “mechanism,” See MPEP 2181(I)(A). The term “configured to” modifies the limited term ‘second linear motion mechanism.’ The limitation “to translate the elongated member within the working lumen of the introducer device in the direction towards the leading edge of the sheath” is functional language describing how the ‘second linear motion mechanism’ functions. "Sufficient structure exists when the claim language specifies the exact structure that performs the function in question without need to resort to other portions of the specification or extrinsic evidence for an adequate understanding of the structure." [emphasis added] ; see also Altiris, Inc. v. Symantec Corp., 318 F.3d 1363, 1376, 65 USPQ2d 1865, 1874 (Fed. Cir. 2003). There are no other limitations within claim 30 describing the structure of the term ‘second linear motion mechanism.’ Therefore, the claim limitation “second linear motion mechanism” does meet the 3-prong analysis and should be interpreted under 35 U.S.C §112(f).
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:
Linear motion mechanism in claim 18 which has structural support illustrated in Figs. 11-2 and described in the specification stating, “Figures 11-12, the linear motion mechanism 172 includes a base plate 174, a motor 176 coupled to the base plate 174, and a timing belt 178 coupled to the motor 176 with a corresponding timing belt pulley 179. Although a timing belt 178 is utilized in the embodiment of Figures 11-12, other linear actuators could be used such as a ball screw, a lead screw, a cable, or a linear motor as non- limiting examples.
Second linear motion mechanism in claim 30 which has structural support illustrated in Figs. 21, 24, and 25 and described in the specification stating, “The elongated member 202 may a second linear motion mechanism 238 configured to translate the elongated member 202 within the working lumen 146 of the introducer device 100 in the direction towards the leading edge 132 of the sheath 118. In addition, the second linear motion mechanism 238 may be configured to rotate the elongated member is 202 as well as translate the elongated member 202 within the working lumen 146. In particular, the actuation of the bending of the elongated member 202 may require linear pulling of a cable along the axis of the elongated member 202.
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 § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 4, 8, 10, 34-35, and 38-39 are rejected under 35 U.S.C. 103 as being unpatentable over Schickling et al. (US5171305), in view of Jeffrey Michael Wendlandt (US6699179) hereinafter Wendlandt.
Regarding Claim 1, Schickling discloses an introducer device (Fig. 1) comprising:
an outer tube (Figs. 1, 4-5 catheter body 13) defining a first lumen (Figs. 1, 4-5 lumen of catheter body 13) and having a first end (see annotated Fig. 4) and a second end (see annotated Fig. 4);
an inner tube (Figs. 1, 4-5 inner tube 17) defining a second lumen (Figs. 4-5 inner tube lumen 31) and having a first end (see annotated fig. 4) and a second end (see annotated fig. 4), wherein the first end (see annotated fig. 4) of the inner tube (Figs. 1, 4-5 inner tube 17) is positioned in the first lumen (Figs. 1, 4-5 lumen of catheter body 13) of the outer tube (Figs. 1, 4-5 catheter body 13), and wherein the inner tube (Figs. 1, 4-5 inner tube 17) is configured to translate (Figs. 4-5) within the first lumen (Figs. 1, 4-5 lumen of catheter body 13) in a direction towards the first end (see annotated Fig. 4) of the outer tube (Figs. 1, 4-5 catheter body 13) from a first position (Fig. 5) to a second position (Fig. 4);
a sheath (Figs. 4-5 everting element 21) having a first end (see annotated fig. 4) and a second end (see annotated fig. 4), wherein the first end of the sheath (see annotated fig. 4) is permanently coupled to the first end (see annotated Fig. 4) of the outer tube (Figs. 1, 4-5 catheter body 13), and wherein the second end of the sheath (Figs. 4-5 everting element 21) is permanently coupled to the first end of the inner tube (see annotated fig. 15);
an inlet port (Fig. 9 injection leg 37) in fluid communication with a space (Figs. 4,5,9 lumen 23) defined by an area between an outer surface of the inner tube (Figs. 1, 4-5 outer surface of inner tube 17), an inner surface of the outer tube (Figs. 1, 4-5 inner surface of catheter body 13), and the sheath (Figs. 4-5 everting element 21), wherein the sheath (Figs. 4-5 everting element 21) is configured to evert from a retracted position (Fig. 5) within the first lumen (Figs. 1, 4-5 lumen of catheter body 13) of the outer tube (Figs. 1, 4-5 catheter body 13) to an extended position (Fig. 4) extending from the first end (see annotated 4) of the outer tube (Figs. 1, 4-5 catheter body 13), wherein the sheath (Figs. 4-5 everting element 21) everts from the retracted position (Fig. 5) to the extended position (Fig. 4) when a leading edge (see annotated 4) of the sheath (Figs. 4-5 everting element 21) is advanced past the first end (see annotated fig. 4) of the outer tube (Figs. 1, 4-5 catheter body 13) by applying a fluid pressure to the space (Figs. 4,5,9 lumen 23) via the inlet port (Fig. 9 injection leg 37) and simultaneously translating the inner tube (Figs. 1, 4-5 inner tube 17) from the first position (Fig. 5) to the second position(Fig. 4) ([col. 4 lines 5-37]), and wherein the sheath (Figs. 4-5 everting element 21) defines a working lumen (see annotated Fig. 5) extending between the leading edge (see annotated 4) and the second end (see annotated 4) of the sheath (Figs. 4-5 everting element 21), wherein the working lumen (see annotated Fig. 5) is open in both the extended position (Fig. 4) and the retracted position (Fig. 5), and wherein the working lumen (see annotated Fig. 5) and the second lumen (Figs. 4-5 inner tube lumen 31) collectively define a channel (see annotated Fig. 5).
PNG
media_image1.png
857
1220
media_image1.png
Greyscale
Schickling is silent as to explicitly teaching one or more steering wires coupled to the sheath, wherein the one or more steering wires are configured to bias a direction of the leading edge of the sheath as the sheath everts from the retracted position to the extended position.
However Wendlandt, in the same field of endeavor, teaches one or more steering wires coupled to the sheath, wherein the one or more steering wires (Wendlandt - Fig. 1 push-pull wires 38) are configured to bias a direction of the leading edge of the sheath as the sheath everts from the retracted position to the extended position (Wendlandt - [col. 7 line 60 – col. 8 line 52] “…push-pull wires 38 are all disposed on the circumference of catheter 2, so that working channel 10 is left free for introduction of endoscopy tools. Push-pull wires 38 exit the body cavity and exit from catheter 2 at the proximal end 6, and can be either manually controlled or can be controlled by the control unit 34. Control unit 34 controls the steering section 36 in a similar manner as it controls the propulsion section 22.When push-pull wires 38 are moved together, the length of the steering section 36 changes, and the tip 40 on distal end 4 of catheter 2 is pushed further in the body cavity, or is withdrawn partially from the body cavity. If push-pull wires 38 are acted on differentially, steering section 36 can be turned in any direction relative to the length of the catheter 2.”)
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to modify the teaching of Schickling with the teachings of Wendlandt to include one or more steering wires coupled to the sheath, wherein the one or more steering wires are configured to bias a direction of the leading edge of the sheath as the sheath everts from the retracted position to the extended position for the benefit of having control of the everting section at the distal end ([col. 7 line 60 – col. 8 line 52]).
Regarding Claim 4, Schickling in view of Wendlandt teach the introducer device of claim 1, wherein the sheath (Wendlandt - Fig. 2 catheter) comprises an inner layer and an outer layer, and wherein the one or more steering wires (Wendlandt - Fig. 1 push-pull wires 38) are positioned between the inner layer of the sheath and the outer layer of the sheath (Wendlandt - [col. 8 lines 1-52] “When push-pull wires 38 are moved together, the length of the steering section 36 changes, and the tip 40 on distal end 4 of catheter 2 is pushed further in the body cavity, or is withdrawn partially from the body cavity. If push-pull wires 38 are acted on differentially, steering section 36 can be turned in any direction relative to the length of the catheter 2. Sutures 42 can be used to attach push-pull wires 38 at discrete locations on the flexible mesh 37, to control their positioning and to support them, so they can transmit compression forces without buckling. Devices other than sutures 42 can be used to hold push-pull wires 38 in position around steering section 36. For example, rigid rings can be fixed at axial locations along the steering section 36, and the push-pull wires 38 can be attached to the rings, or may be threaded through holes formed in the ring's outer portion. Alternatively, simple clips or loops can be used to tie push-pull wires 38 to specific points of mesh 37, so the wires can move only in the axial direction. Heat shrink, polyurethane, or other type of low friction flexible cladding can be applied on top of flexible mesh 37 and wires 38 to facilitate insertion and travel of the device within the body cavity. The use of a slippery coating for the catheter makes it easier for the propulsion section 22 to pull the catheter along the body cavity, and also reduces discomfort to the patient. The low friction coating can also be used on the inside of the cladding, to reduce friction with push-pull wires 38. In a further embodiment according to the invention, the steering section 36 can have an outer surface formed by bellows instead of the flexible mesh 37.”).
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to modify Schickling with the teachings of Wendlandt to include wherein the sheath comprises an inner layer and an outer layer, and wherein the one or more steering wires are positioned between the inner layer of the sheath and the outer layer of the sheath for the benefit of “…to control[ing the one or more steering wires]… positioning and to support them, so they can transmit compression forces without buckling” (Wendlandt - [col. 8 lines 1-52]).
Regarding Claim 8, Schickling in view of Wendlandt teach the introducer device of claim 1, wherein the one or more steering wires (Wendlandt - Fig. 1 push-pull wires 38) comprise a first steering wire (Wendlandt - Fig. 3 push-pull wires 38) positioned on a first side of the sheath (Wendlandt - Fig. 2 catheter) and a second steering wire (Wendlandt - Fig. 3 push-pull wires 38) positioned on a second side of the sheath (Wendlandt - Fig. 2 catheter) opposite the first side (Wendlandt – see Fig. 3).
Regarding Claim 10, Schickling in view of Wendlandt teach the introducer device of claim 1, further comprising: a fluid seal (Schickling – sealed area within chamber 35, [col. 4 lines 5-43] “With this construction, an inflation media can be supplied to the chamber 35 to control the inversion and eversion of the everting element 21. The inner tube 17 can be moved axially within the lumen 23 to also control the inverting and everting movements of the everting element 21.”) extending from the outer surface of the inner tube (Figs. 1, 4-5 outer surface of inner tube 17) to the inner surface of the outer tube (Schickling - Figs. 1, 4-5 inner surface of catheter body 13), wherein the fluid seal is positioned between the inlet port (Schickling - Fig. 9 injection leg 37) and the second end (See annotated Fig. 4) of the outer tube (Schickling - Figs. 1, 4-5 catheter body 13).
PNG
media_image1.png
857
1220
media_image1.png
Greyscale
Regarding Claim 34, Schickling in view of Wendlandt teach a method comprising:
positioning the introducer device of claim 1 (see claim 1 above) in proximity to a body lumen of a patient (Schickling – [col 1 lines 6-11]);
applying, via the inlet port (Schickling – Fig. 9 injection leg 37) of the introducer device (Schickling – Fig. 1), fluid pressure to the space between the outer surface of the inner tube (Figs. 1, 4-5 outer surface of inner tube 17), the inner surface of the outer tube (Figs. 1, 4-5 inner surface of catheter body 13), and the sheath (Schickling – Figs. 4-5 everting element 21, [col. 4 lines 11-43] “The everting element 21 is a thin, flexible membrane which is constructed of a suitable polymeric material. As shown in FIGS. 4 and 5, the everting element 21 is bonded as by an adhesive to an outer surface of the catheter body 13 adjacent the distal end 25 and to an outer surface of the inner tube 17. This forms a chamber 35 which communicates with the lumen 23 of the catheter body 13 outside of the inner tube 17. As shown in FIG. 9, the lumen 23 communicates with an injection leg 37 of the proximal fitting 15 so that an inflation media can be supplied to the lumen 23 and the chamber 35. A seal 39 carried by the proximal fitting 15 prevents the inflation media from exiting through a leg 41 of the fitting 15.”; and
translating the inner tube (Schickling – Figs. 1, 4-5 inner tube 17) from the first position (Schickling – Fig. 5) to the second position (Schickling – Fig. 4) to thereby cause the sheath (Schickling – Figs. 4-5 everting element 21) to evert from the retracted positioned (Schickling – Fig. 5) within the first lumen (Schickling – Figs. 1, 4-5 lumen of catheter body 13) of the outer tube (Schickling – Figs. 1, 4-5 catheter body 13) to the extended position (Schickling – Fig. 4) extending from the first end of the outer tube (see annotated 4) until the leading edge (see annotated 4) of the sheath (Schickling – Figs. 4-5 everting element 21) reaches a target anatomy in the patient (Schickling – [col. 4 lines 11-43] “With this construction, an inflation media can be supplied to the chamber 35 to control the inversion and eversion of the everting element 21. The inner tube 17 can be moved axially within the lumen 23 to also control the inverting and everting movements of the evert ing element 21”).
PNG
media_image1.png
857
1220
media_image1.png
Greyscale
Regarding Claim 35, Schickling in view of Wendlandt teach method of claim 34, further comprising: biasing, via the one or more steering wires of the introducer device, the direction of the leading edge of the sheath as the sheath everts from the retracted position to the extended position to direct the leading edge of the sheath to the target anatomy (Wendlandt - [col. 8 lines 1-52] “When push-pull wires 38 are moved together, the length of the steering section 36 changes, and the tip 40 on distal end 4 of catheter 2 is pushed further in the body cavity, or is withdrawn partially from the body cavity. If push-pull wires 38 are acted on differentially, steering section 36 can be turned in any direction relative to the length of the catheter 2. Sutures 42 can be used to attach push-pull wires 38 at discrete locations on the flexible mesh 37, to control their positioning and to support them, so they can transmit compression forces without buckling. Devices other than sutures 42 can be used to hold push-pull wires 38 in position around steering section 36. For example, rigid rings can be fixed at axial locations along the steering section 36, and the push-pull wires 38 can be attached to the rings, or may be threaded through holes formed in the ring's outer portion. Alternatively, simple clips or loops can be used to tie push-pull wires 38 to specific points of mesh 37, so the wires can move only in the axial direction. Heat shrink, polyurethane, or other type of low friction flexible cladding can be applied on top of flexible mesh 37 and wires 38 to facilitate insertion and travel of the device within the body cavity. The use of a slippery coating for the catheter makes it easier for the propulsion section 22 to pull the catheter along the body cavity, and also reduces discomfort to the patient. The low friction coating can also be used on the inside of the cladding, to reduce friction with push-pull wires 38. In a further embodiment according to the invention, the steering section 36 can have an outer surface formed by bellows instead of the flexible mesh 37.”).
Regarding Claim 38, Schickling in view of Wendlandt teach the method of claim 34, further comprising: positioning an elongated member (Schickling – [col. 5 lines 43-50] “The tubular layer 49 provides a smooth inner surface 55 for the surface of the inner tube lumen 31. The tubular layer 49 is preferably constructed of a polymeric material and, optimally, includes a lubricious material which defines the inner surface 55 and which aids the passage of an instrument through the inner tube lumen 31. Examples of suitable materials include polyethylene and nylon.”) at least partially within a working lumen (Schickling – see annotated Figs. 4-5) of the introducer device (Schickling – Fig. 1) , wherein the working lumen (Schickling – see annotated Figs. 4-5) of the introducer device is defined by a space between opposing walls of the sheath (Schickling – see annotated Figs. 4-5); and translating the elongated member through the working lumen in a direction towards the leading edge of the sheath (Schickling – Figs. 4-5 everting element 21 , [col. 6 lines 37-54] “Accordingly, the inner tube lumen 31 remains open for drug infusion, aspiration and/or the insertion of any of a variety of medical instruments, including an endoscope.”) .
PNG
media_image1.png
857
1220
media_image1.png
Greyscale
Regarding Claim 39, Schickling in view of Wendlandt teach the method of claim 38, wherein the elongated member (Schickling – [col. 4 lines 11-37] “Any media infused through the leg 32 passes through the inner tube lumen 31 and out through the distal end 33. The fitting 19 has a leg 34 which provides a port for the introduction of a variety of medical instruments, such as an endoscope.”) is translated through the working lumen (Schickling – see annotated Fig. 4) in the direction towards the leading edge (Schickling – see annotated Fig. 4) of the sheath (Schickling – Figs. 4-5 everting element 21 , [col. 6 lines 37-54] “Accordingly, the inner tube lumen 31 remains open for drug infusion, aspiration and/or the insertion of any of a variety of medical instruments, including an endoscope.”) (i) at a first speed such that there is no friction between the elongated member and the sheath, (Schickling – [col. 5 lines 43-50] “The tubular layer 49 provides a smooth inner surface 55 for the surface of the inner tube lumen 31. The tubular layer 49 is preferably constructed of a polymeric material and, optimally, includes a lubricious material which defines the inner surface 55 and which aids the passage of an instrument through the inner tube lumen 31. Examples of suitable materials include polyethylene and nylon.”) or (ii) at one half the first speed such that a distal end of the elongated member is aligned with the leading edge of the sheath as the sheath everts from the retracted position to the extended position.
PNG
media_image1.png
857
1220
media_image1.png
Greyscale
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Schickling in view of Wendlandt in view of Dennis Boulais (US2006/0074383) hereinafter Boulais.
Regarding claim 5, Schickling in view of Wendlandt teach the introducer device of claim 4, but is silent as to whether there is a lubricant or a surfactant is positioned between the inner layer of the sheath and the outer layer of the sheath wherein the one or more steering wires are located.
However Boulais, in the same field of endeavor, teaches a lubricant or a surfactant is positioned between the inner layer of the sheath and the outer layer of the sheath wherein the one or more steering wires are located ([0037] “[0037] The control wires 140A and 140B may be of the pull or tension type, and are preferably made of a non-stretching material, such as stainless steel, braided polymer fibers, or the like. The control wires 140A and 140B are preferably carried in stainless steel or plastic sleeves 146 through the proximal section 40 so as to be protected from and to not interfere with the components routed through the central passageway of the device 24. As such, the guide lumens 84A and 84B of the distal and proximal caps 56 and 60 are configured for receiving the ends of the protective sleeve 146, as best shown in FIG. 3. While not shown, it will be appreciated that the protective sleeves 146 may extend from the proximal end of the control wires 140A and 140B to the distal end of the control wires, or along any portion thereof. In one embodiment of the invention, the control wires 140A and 140B are Bowden cables and are coated with a lubricant, such as silicone, in order to reduce friction, and the protective sleeves 146 include a lubricous liner, such as HDPE.”)
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to modify the teachings of Schickling in view of Wendlandt teach with the teachings of Boulais to include a lubricant or a surfactant is positioned between the inner layer of the sheath and the outer layer of the sheath wherein the one or more steering wires are located for the benefit of reducing friction between the steering wires and the inner layer of the sheath and the outer layer of the sheath [0037].
Claim 6 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Schickling in view of Wendlandt in view of Woodley et al (US2009/0099420) hereinafter Woodley
Regarding claim 6, Schickling in view of Wendlandt teach the introducer device of claim 1, but fails to explicitly state further comprising: one or more motors coupled to the one or more steering wires, wherein activation of the one or more motors adjusts a length of the one or more steering wires to thereby bias the direction of the leading edge of the sheath as the sheath everts from the retracted position to the extended position.
However Woodley, in the same field of endeavor teaches, one or more motors coupled to the one or more steering wires, wherein activation of the one or more motors adjusts a length of the one or more steering wires to thereby bias the direction of the leading edge of the sheath as the sheath everts from the retracted position to the extended position (Woodley - [0026] “Preferably, automatically controlled proximal portion 16 comprises a plurality of segments 28, which are controlled via computer and/or electronic controller 30. Such an automatically controlled endoscope is described in further detail in commonly assigned U.S. patent application Ser. Nos. 10/229,577 (now U.S. Pat. No. 6,858,005) and 11/750,988, both previously incorporated herein by reference. Preferably, the distal end of a tendon (more thoroughly described below) is mechanically connected to each segment 28 or steerable distal portion 14, with the proximal end of the tendon mechanically connected to actuators to articulate segments 28 or steerable distal portion 14, which is more fully described below and in U.S. patent application Ser. Nos. 10/229,577 (now U.S. Pat. No. 6,858,005) and 11/750,988, both previously incorporated herein by reference. The actuators driving the tendons may include a variety of different types of mechanisms capable of applying a force to a tendon, e.g., electromechanical motors, pneumatic and hydraulic cylinders, pneumatic and hydraulic motors, solenoids, shape memory alloy wires, electronic rotary actuators or other devices or methods as known in the art. If shape memory alloy wires are used, they are preferably configured into several wire bundles attached at a proximal end of each of the tendons within the controller. Segment articulation may be accomplished by applying energy, e.g., electrical current, electrical voltage, heat, etc., to each of the bundles to actuate a linear motion in the wire bundles which in turn actuate the tendon movement. The linear translation of the actuators within the controller may be configured to move over a relatively short distance to accomplish effective articulation depending upon the desired degree of segment movement and articulation.”).
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to modify Schickling in view of Wendlandt with the teachings of Woodley and further comprise one or more motors coupled to the one or more steering wires, wherein activation of the one or more motors adjusts a length of the one or more steering wires to thereby bias the direction of the leading edge of the sheath as the sheath everts from the retracted position to the extended position, as taught by Woodley, for the benefit of “…accomplish[ing] effective articulation depending upon the desired degree of segment movement and articulation” (Woodley - [0126]).
Regarding claim 18, Schickling in view of Wendlandt teach the introducer device of claim 1, but fails to explicitly disclose further comprising: a linear motion mechanism configured to translate the inner tube within the first lumen of the outer tube in the direction towards the first end of the outer tube from the first position to the second position.
However Woodley, in the same field of endeavor, teaches a linear motion mechanism (Examiner’s Note: as previously stated above under the claim interpretation section, a linear motion mechanism is being interpreted as a structure capable of having “…a base plate 174, a motor 176 coupled to the base plate 174, and a timing belt 178 coupled to the motor 176 with a corresponding timing belt pulley 179. Although a timing belt 178 is utilized in the embodiment of Figures 11-12, other linear actuators could be used such as a ball screw, a lead screw, a cable, or a linear motor as non- limiting examples.” Here Woodley has such structure in the controlled proximal portion 16, see [0026].) configured to translate the inner tube within the first lumen of the outer tube in the direction towards the first end of the outer tube from the first position to the second position (Woodley - [0026] “Preferably, automatically controlled proximal portion 16 comprises a plurality of segments 28, which are controlled via computer and/or electronic controller 30. Such an automatically controlled endoscope is described in further detail in commonly assigned U.S. patent application Ser. Nos. 10/229,577 (now U.S. Pat. No. 6,858,005) and 11/750,988, both previously incorporated herein by reference. Preferably, the distal end of a tendon (more thoroughly described below) is mechanically connected to each segment 28 or steerable distal portion 14, with the proximal end of the tendon mechanically connected to actuators to articulate segments 28 or steerable distal portion 14, which is more fully described below and in U.S. patent application Ser. Nos. 10/229,577 (now U.S. Pat. No. 6,858,005) and 11/750,988, both previously incorporated herein by reference. The actuators driving the tendons may include a variety of different types of mechanisms capable of applying a force to a tendon, e.g., electromechanical motors, pneumatic and hydraulic cylinders, pneumatic and hydraulic motors, solenoids, shape memory alloy wires, electronic rotary actuators or other devices or methods as known in the art. If shape memory alloy wires are used, they are preferably configured into several wire bundles attached at a proximal end of each of the tendons within the controller. Segment articulation may be accomplished by applying energy, e.g., electrical current, electrical voltage, heat, etc., to each of the bundles to actuate a linear motion in the wire bundles which in turn actuate the tendon movement. The linear translation of the actuators within the controller may be configured to move over a relatively short distance to accomplish effective articulation depending upon the desired degree of segment movement and articulation.” Examiner’s Note: As the 112f claim interpretation identifies above, the liner motion mechanism is interpreted as a ‘linear actuator.’ Here Woodley discloses a linear actuator within the controller via the use a computer or electronic controller or actuator driving tendon mechanism for capable for applying force to a tendon as described above.).
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to modify Schickling in view of Wendlandt with the teachings of Woodley and further comprise a linear motion mechanism configured to translate the inner tube within the first lumen of the outer tube in the direction towards the first end of the outer tube from the first position to the second position, as taught by Woodley, for the benefit of “…accomplish[ing] effective articulation depending upon the desired degree of segment movement and articulation” (Woodley - [0126]).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Schickling in view of Wendlandt in view of Dann et al. (US2014/0358065) hereinafter Dann.
In regard to claim 7, Schickling in view of Wendlandt teach the introducer device of claim1, but fail to explicitly teach further comprising: one or more electromechanical brakes coupled to the one or more steering wires, wherein activation of the one or more brakes adjusts a length of the one or more steering wires to thereby bias the direction of the leading edge of the sheath as the sheath everts from the retracted position to the extended position.
However Dann, in the same field of endeavor, teaches further comprising: one or more electromechanical brakes coupled to the one or more steering wires, wherein activation of the one or more brakes adjusts a length of the one or more steering wires to thereby bias the direction of the leading edge of the sheath as the sheath everts from the retracted position to the extended position (Dann - [0126] “ In some embodiments, the safety device, such as a control wire can function as a “brake” to reduce the velocity of the distally advancing sleeve by providing a proximally retracting force on the sleeve, which in turn will reduce the net pressure the sleeve exerts on the luminal wall when the sleeve comes into contact with the luminal wall. The safety device, e.g., a control wire can also mechanically assist in eversion of the sleeve, reducing the internal sleeve pressure and thus reducing the risk of sleeve deformation that could in turn transmit pressure to the body luminal wall by direct contact, or alternatively by the inflation media if the sleeve actually ruptures.”).
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to modify the teachings Schickling in view of Wendlandt to further comprising: one or more electromechanical brakes coupled to the one or more steering wires, wherein activation of the one or more brakes adjusts a length of the one or more steering wires to thereby bias the direction of the leading edge of the sheath as the sheath everts from the retracted position to the extended position, as taught by Dann, for the benefit of “…reducing the risk of sleeve deformation that could in turn transmit pressure to the body luminal wall by direct contact, or alternatively by the inflation media if the sleeve actually ruptures” (Dann - [0126]).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Schickling in view of Wendlandt in view of Woodley in view of Okamoto et al. (US2016/0113481) hereinafter Okamoto.
Regarding claim 19, Schickling in view of Wendlandt in view of Woodley teach the introducer device of claim 18, but alone or in combination to fail to explicitly disclose wherein the linear motion mechanism comprises: a base plate; a motor coupled to the base plate; a timing belt coupled to the motor; an inner tube mount coupled to the inner tube, wherein the timing belt is coupled to the inner tube mount such that motion of the timing belt is translated into linear motion of the inner tube; and a linear bearing positioned between the inner tube mount and the base plate.
However Okamoto, in the same field of endeavor, teaches wherein the linear motion mechanism comprises: a base plate; a motor (Okamoto - [0038] “The operating section 3 includes a grip section 12 connected to the inserting section 2, and is constituted of a UD knob (a rotary knob) 7 that bends the bending section 4 in the UD (Up/Down) directions, an RL (Right/Left) dial 8 that bends the bending section 4 in the RL directions, an operation element 17 that is arranged in the later-described operating section 3 including the RL dial 8, and an electric bending drive mechanism 10 that is accommodated in an upper portion of the operating section 3 and includes a motor (not shown) that is an electric drive source.”) coupled to the base plate (Figs. 15a-b operating section 3); a timing belt coupled to the motor ([0095-0096] “[0095] Furthermore, as shown in FIG. 15B, an annular belt 95 covered with a sheath 96 is linearly stretched with tension between the rotary shaft 92 and the driven shaft 97. In addition, it is preferable to form a U groove or the like on each of the rotary shaft 92 and the drive shaft 97 so that the belt 95 cannot be displaced from a predetermined position. This belt 95 is used as a transmission mechanism that transmits rotation of the rotary shaft 92 to the drive shaft 97. Thus, it is preferable to create the belt by using a grippy material such as rubber. In addition, in case of setting a rotation ratio of the rotary shaft 92 and the drive shaft 97 described with reference to FIG. 8, shaft diameters may be changed, but a pulley having a diameter that realizes the rotation ratio may be additionally disposed. [0096] Besides, as the belt 95, a V groove may be formed on each of the rotary shaft 92 and the drive shaft 97, and a V belt may be used. Moreover, a timing pulley having a diameter meeting a preset rotation ratio (equal to an output shown in FIG. 8) of each shaft may be fixed, and a toothed belt, which is a so-called timing belt, may be adopted as the belt 95. Additionally, a combination of the gear and the chain may be applied.”); an inner tube mount coupled to the inner tube (Okamoto - Figs. 15b sheath 96), wherein the timing belt (Okamoto - [0095-0096]) is coupled to the inner tube mount such that motion of the timing belt (Okamoto - [0095-0096]) is translated into linear motion of the inner tube (Okamoto - Figs. 15b sheath 96); and a linear bearing positioned between the inner tube mount and the base plate (Okamoto - Figs. 15a-b operating section 3).
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to modify the teachings of Schickling in view of Wendlandt in view of the teachings of Woodley to have the linear motion mechanism comprises: a base plate; a motor coupled to the base plate; a timing belt coupled to the motor; an inner tube mount coupled to the inner tube, wherein the timing belt is coupled to the inner tube mount such that motion of the timing belt is translated into linear motion of the inner tube; and a linear bearing positioned between the inner tube mount and the base plate, as taught by Okamoto, for the benefit of having “…a timing pulley having a diameter meeting a preset rotation ratio” (Okamoto - [0096]).
Claim 22, 24, 26, and 43 are rejected under 35 U.S.C. 103 as being unpatentable over Schickling in view of Wendlandt teach in view of Inglis et al. (US2019/0142262) hereinafter Inglis.
Regarding claim 22, Schickling in view of Wendlandt teach discloses a system comprising:
the introducer device of claim1 (see claim 1 above);
an elongated member (Schickling – [col. 5 lines 43-50] “The tubular layer 49 provides a smooth inner surface 55 for the surface of the inner tube lumen 31. The tubular layer 49 is preferably constructed of a polymeric material and, optimally, includes a lubricious material which defines the inner surface 55 and which aids the passage of an instrument through the inner tube lumen 31.” And [col. 6 line 51-55] “Accordingly, the inner tube lumen 31 remains open for drug infusion, aspiration and/or the insertion of any of a variety of medical instruments, including an endoscope.”) positioned at least partially within the working lumen (Schickling – see annotated Fig. 4) of the introducer device (see claim 1 above), wherein the working lumen (Schickling – see annotated Fig. 4) of the introducer device is defined by a space (Schickling – see annotated Fig. 4 as identified ‘working lumen’) between opposing walls of the everted sheath (Schickling – Figs. 4-5 everting element 21);
PNG
media_image1.png
857
1220
media_image1.png
Greyscale
Schickling in view of Wendlandt is silent whether further comprising at least one processor; and data storage including program instructions stored thereon that when executed by the at least one processor, cause the system to: apply, via the inlet port, fluid pressure to the space between the outer surface of the inner tube, the inner surface of the outer tube, and the sheath; translate the inner tube from the first position to the second position to thereby cause the sheath to evert from the retracted positioned within the first lumen of the outer tube to the extended position extending from the first end of the outer tube; and translate the elongated member through the working lumen in a direction towards the leading edge of the sheath.
However Inglis, in the same field of endeavor teaches at least one processor; and data storage including program instructions stored thereon that when executed by the at least one processor, cause the system to: apply, via the inlet port, fluid pressure to the space between the outer surface of the inner tube, the inner surface of the outer tube, and the sheath; translate the inner tube from the first position to the second position to thereby cause the sheath to evert from the retracted positioned within the first lumen of the outer tube to the extended position extending from the first end of the outer tube; and translate the elongated member through the working lumen in a direction towards the leading edge of the sheath. (Inglis - [0071] “[0071] In one embodiment, the processor may detect a signal from an introducer when the introducer is coupled to the hub 60. The signal is passed from the electrical connector 94 of the introducer through the electrical connector 82 of the hub 60, to the processor 70. The signal may be an introducer identification signal that identifies the coupled introducer. For example, the identification signal may be an alphanumeric code, serial number, identification information, or other information stored in a hardware memory 96 on the introducer. Once the signal is detected, the visualization instrument 48 may switch from a default laryngoscope operating mode to a multifunctional visualization instrument operating mode. A similar identification signal may be received from a laryngoscope blade 38. In one embodiment, the memory 72 on the visualization instrument 48 may receive and store laryngoscope blade identification information and/or introducer identification information for an attached laryngoscope blade 38 or introducer 50. The stored information may be retrieved and compared to the introducer identification signal or laryngoscope blade signal to look for a match, for quality or other assessments. The introducer 50 may also include a working channel configured for suctioning (e.g., a suction lumen) or configured to accommodate a device, such as a biopsy tool, an ablation tool, etc. Accordingly, the stored information may also include information about the working channel.
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to modify the teachings of Schickling in view of Wendlandt in view of the teachings of Inglis to include at least one processor; and data storage including program instructions stored thereon that when executed by the at least one processor, cause the system to: apply, via the inlet port, fluid pressure to the space between the outer surface of the inner tube, the inner surface of the outer tube, and the sheath; translate the inner tube from the first position to the second position to thereby cause the sheath to evert from the retracted positioned within the first lumen of the outer tube to the extended position extending from the first end of the outer tube; and translate the elongated member through the working lumen in a direction towards the leading edge of the sheath for the benefit of storing information that may be retrieve din the future for quick comparison and quality checks (Inglis [0071]).
Regarding claim 24, Schickling in view of Wendlandt in view of Inglis teach the system of claim 22, wherein the program instructions are further executable by the at least one processor to cause the system to: determine, based on one or more sensors positioned in the sheath, a pressure in the space between the outer surface of the inner tube, the inner surface of the outer tube, and the sheath; and adjust, based on the determined pressure, the fluid pressure applied to the space (Inglis - [0071] “[0071] In one embodiment, the processor may detect a signal from an introducer when the introducer is coupled to the hub 60. The signal is passed from the electrical connector 94 of the introducer through the electrical connector 82 of the hub 60, to the processor 70. The signal may be an introducer identification signal that identifies the coupled introducer. For example, the identification signal may be an alphanumeric code, serial number, identification information, or other information stored in a hardware memory 96 on the introducer. Once the signal is detected, the visualization instrument 48 may switch from a default laryngoscope operating mode to a multifunctional visualization instrument operating mode. A similar identification signal may be received from a laryngoscope blade 38. In one embodiment, the memory 72 on the visualization instrument 48 may receive and store laryngoscope blade identification information and/or introducer identification information for an attached laryngoscope blade 38 or introducer 50. The stored information may be retrieved and compared to the introducer identification signal or laryngoscope blade signal to look for a match, for quality or other assessments. The introducer 50 may also include a working channel configured for suctioning (e.g., a suction lumen) or configured to accommodate a device, such as a biopsy tool, an ablation tool, etc. Accordingly, the stored information may also include information about the working channel.
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to modify the teachings of Schickling in view of Wendlandt in view of the teachings of Inglis to have the program instructions are further executable by the at least one processor to cause the system to: determine, based on one or more sensors positioned in the sheath, a pressure in the space between the outer surface of the inner tube, the inner surface of the outer tube, and the sheath; and adjust, based on the determined pressure, the fluid pressure applied to the space for the benefit of storing information that may be retrieve din the future for quick comparison and quality checks (Inglis - [0071]).
Regarding claims 26, Schickling in view of Wendlandt in view of Inglis teach the system of claim 22, wherein the program instructions are further executable by the at least one processor to cause the system to: capture, via a camera (Inglis - Figs. 5, 7 camera 55) of the endoscope, one or more images of an anatomy into which the sheath of the introducer device is positioned; and based on the captured one or more images, bias the direction of the leading edge of the sheath via the one or more steering wires coupled to the sheath as the sheath everts from the retracted position to the extended position to direct the leading edge of the sheath to a target anatomy (Inglis - [0073-0075] and [0089] “This configuration is particularly useful during replacement of an existing intubated endotracheal tube. During tube replacement, the introducer 50 is coupled to the control device 57 and is inserted into an endotracheal tube that is already in place in the patient's airway. When the introducer includes a camera, an image from the endoscope camera can be viewed on the control device 57 to facilitate insertion of the introducer 50 into the endotracheal tube.” [0096] “Further, the processor 70 may use feedback from one or more of the camera 55, the camera 74 (see FIG. 6), or one or more sensors 154 to adjust the displayed image to a desired orientation. In one example, the image data (e.g., the introducer image) from the introducer camera 55 is provided to the processor 70, which in turn process the image data and uses image recognition to determine a position of the introducer distal end 54 based on shape or size characteristics of the portions of the airway recognized from the image data. For example, the microprocessor 70 may be programmed to identify vocal cords in an image from the endoscope camera 55. Feedback from the gyroscope 155 may provide additional information as to the orientation of the introducer distal end 54 within the passage. With image recognition and/or gyroscope input, the microprocessor 70 can identify the anterior direction within the image, and orient the image on the laryngoscope display screen 22 such that the anterior direction is maintained toward the top of the laryngoscope display screen 22.”).
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to modify the teachings of Schickling in view of Wendlandt in view of Inglis to have one processor to cause the system to: capture, via a camera of the endoscope, one or more images of an anatomy into which the sheath of the introducer device is positioned; and based on the captured one or more images, bias the direction of the leading edge of the sheath via the one or more steering wires coupled to the sheath as the sheath everts from the retracted position to the extended position to direct the leading edge of the sheath to a target anatomy the benefit of determining the position of the introducer (Inglis - [0096]).
Regarding claims 43, Schickling in view of Wendlandt teach the method of claim 34, but fails to disclose further comprising: capturing, via a camera of the endoscope, one or more images of an anatomy into which the sheath of the introducer device is positioned; and based on the captured one or more images, biasing the direction of the leading edge of the sheath via the one or more steering wires coupled to the sheath as the sheath everts from the retracted position to the extended position to direct the leading edge of the sheath to the target anatomy of the patient.
However Inglis, in the same field of endeavor, teaches further comprising: capturing, via a camera (Inglis -Figs. 5, 7 camera 55) of the endoscope, one or more images of an anatomy into which the sheath of the introducer device is positioned; and based on the captured one or more images, biasing the direction of the leading edge of the sheath via the one or more steering wires coupled to the sheath as the sheath everts from the retracted position to the extended position to direct the leading edge of the sheath to the target anatomy of the patient (Inglis - [0073-0075] and [0089] “This configuration is particularly useful during replacement of an existing intubated endotracheal tube. During tube replacement, the introducer 50 is coupled to the control device 57 and is inserted into an endotracheal tube that is already in place in the patient's airway. When the introducer includes a camera, an image from the endoscope camera can be viewed on the control device 57 to facilitate insertion of the introducer 50 into the endotracheal tube.” [0096] “Further, the processor 70 may use feedback from one or more of the camera 55, the camera 74 (see FIG. 6), or one or more sensors 154 to adjust the displayed image to a desired orientation. In one example, the image data (e.g., the introducer image) from the introducer camera 55 is provided to the processor 70, which in turn process the image data and uses image recognition to determine a position of the introducer distal end 54 based on shape or size characteristics of the portions of the airway recognized from the image data. For example, the microprocessor 70 may be programmed to identify vocal cords in an image from the endoscope camera 55. Feedback from the gyroscope 155 may provide additional information as to the orientation of the introducer distal end 54 within the passage. With image recognition and/or gyroscope input, the microprocessor 70 can identify the anterior direction within the image, and orient the image on the laryngoscope display screen 22 such that the anterior direction is maintained toward the top of the laryngoscope display screen 22.”).
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to modify the teachings of Dann in view of Inglis to have one processor to cause the system to: further comprising: capturing, via a camera of the endoscope, one or more images of an anatomy into which the sheath of the introducer device is positioned; and based on the captured one or more images, biasing the direction of the leading edge of the sheath via the one or more steering wires coupled to the sheath as the sheath everts from the retracted position to the extended position to direct the leading edge of the sheath to the target anatomy of the patient for the benefit of determining the position of the introducer [Inglis - 0096].
Claim 29 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Schickling in view of Wendlandt teach in view of Inglis in further view of Hans Henrik Iuel (US2015/0366436) hereinafter Iuel.
Regarding claim 29, Schickling in view of Wendlandt in view of Inglis teach the system of claim 22, but fail to explicitly teach wherein the elongated member includes one or more bending slits, and wherein the elongated member further includes a cable coupled to the elongated member just distal to the one or more slits can be pulled to actuate bending of the elongated member in the direction of the slits.
However Iuel, in the same field of endeavor, teaches wherein the elongated member (Iuel – Fig. 1 endoscope 1) includes one or more bending slits (Iuel – see annotated Fig. 2), and wherein the elongated member (Iuel – Fig. 1 endoscope 1) further includes a cable (Iuel – Fig. 2 pull wire 15) coupled to the elongated member (Iuel – Fig. 1 endoscope 1) just distal to the one or more slits can be pulled to actuate bending of the elongated member in the direction of the slits (Iuel – [0039-0040] “These pull-wires 15 form part of a pair of Bowden cables leading to the operating handle 2, in which the proximal ends of the pull-wires are connected to a lever 8 connected to the control knob 14, as can be seen in FIGS. 3 or 5. By tensioning the pull-wire 15 on one side and slacking it on the other side, the articulated tip part 3 may be deflected to one side collapsing the V-shaped grooves 7 on that side and expanding them on the opposite side. In order to achieve full deflection, it is important that the pull-wire 15 may be pulled sufficiently far back into the insertion tube 12 before the control knob 14 or the lever 8 thereof abuts the operating handle housing 13 of the operating handle 2.”).
PNG
media_image2.png
384
502
media_image2.png
Greyscale
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to modify the teachings of Schickling in view of Wendlandt in view of Inglis with the teachings of Iuel to include wherein the elongated member includes one or more bending slits, and wherein the elongated member further includes a cable coupled to the elongated member just distal to the one or more slits can be pulled to actuate bending of the elongated member in the direction of the slits for the benefit of achieving “full deflection of the articulated tip part … during operation” (Iuel – [0014, 0023, 0040, 0055]).
Regarding claim 30, Schickling in view of Wendlandt in view of Inglis teach the system of claim 22, but fail to explicitly teach wherein the elongated member includes a second linear motion mechanism configured to translate the elongated member within the working lumen of the introducer device in the direction towards the leading edge of the sheath.
However Iuel, in the same field of endeavor, teaches wherein the elongated member (Iuel – Fig. 1 endoscope 1) includes a second linear motion mechanism (Iuel – Fig. 14c wires 11, Examiner’s Note: As identified above in 112f claim interpretation, a second linear motion mechanism is being interpreted as ‘..a linear pulling of a cable along the axis of the elongated member 202.’ Here Iuel discloses wires, which are capable of linearly pulling a cable along an axis.) configured to translate the elongated member (Iuel – Fig. 1 endoscope 1) within the working lumen of the introducer device in the direction towards the leading edge of the sheath. (Examiner’s Note: The terms “configured to translate the elongated member within the working lumen of the introducer device in the direction towards the leading edge of the sheath” is functional language and being interpreted as a recitation with respect to the manner in which a claimed apparatus is intended to be used. See MPEP 2114(II), MPEP 2111.04.)
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to modify the teachings of Schickling in view of Wendlandt in view of Inglis with the teachings of Iuel to include wherein the elongated member includes a second linear motion mechanism configured to translate the elongated member for the benefit of achieving “full deflection of the articulated tip part … during operation” (Iuel – [0014, 0023, 0040, 0055]).
Allowable Subject Matter
Claim 21 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is an examiner’s statement of reasons for allowable subject matter:
The prior art fails to teach among other features, an introducer device of claim 1 wherein the sheath includes a first pressure section in fluid communication with the inlet port, and wherein the sheath further includes a second pressure section in fluid communication with a second inlet port such that a pressure in the first pressure section of the sheath can be different than a pressure in the second pressure section of the sheath to thereby further bias the direction of the leading edge of the sheath as the sheath everts from the retracted position to the extended position.
None of the prior art listed above, alone or in obvious combination, with each other, or in obvious combination with, Eidenschink et al. (US2011/0065988), Chin et al. (US2017/0360475), or Lowery et al. (US5364345) teach wherein the sheath includes a first pressure section in fluid communication with the inlet port, and wherein the sheath further includes a second pressure section in fluid communication with a second inlet port such that a pressure in the first pressure section of the sheath can be different than a pressure in the second pressure section of the sheath to thereby further bias the direction of the leading edge of the sheath as the sheath everts from the retracted position to the extended position.
There is no reason or suggestion provided in the prior art to modify the above prior art to have the additional features as claimed above, and the only reason to modify the references would be based on Applicant’s disclosure, which is impermissible hindsight reasoning.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEGAN E MONAHAN whose telephone number is (571)272-7330. The examiner can normally be reached Monday - Friday, 8am - 5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Carey can be reached on (571) 270-7235. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MEGAN ELIZABETH MONAHAN/Examiner, Art Unit 3795
Prosecution Insights