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 07/28/25 has been entered. Claims 1 and 14 have been amended. Claims 2-8, 11-12, 15-22, and 24 are in the original/ previously presented form. Claims 9-10, 13, and 23 are cancelled. Claims 25-28 are newly presented. Thus, claims 1-8, 11-12, 14-22, and 24-28 remain pending in the application. There were no objections or 112 rejections previously set forth in the Non-Final Office Action mailed 04/28/25. Therefore, there are no objections or 112 rejections withstanding.
Claim Objections
Claims 2, 17, 18, and 28 are objected to because of the following informalities:
Claim 2 lines 1-2 include the recitation of “wherein in an unbent state: the flexible shaft extends along the shaft axis,” that should likely be removed because the limitation of “wherein in an unbent state: the flexible shaft extends along the shaft axis,” appears to be in duplicate since the limitation has already been recited in independent claim 1, from which claim 2 depends (assuming the flexible and bendable shafts refer to the same structure, see 112b rejection below)
Claim 17 line 1 reads “the first and second sides” and should likely read “[[the]] a first and a second side[[s]]” to provide proper antecedent basis for first and second side which have yet to be recited in the claim language, since these recitations were removed in the amendment to independent claim 14
Claim 18: each first recitation of first/second lever, first/second wire rope, and first/second wire should be preceded by “a” instead of “the” to provide proper antecedent basis for the structures, since these recitations were removed in the amendment to independent claim 14
Claim 28: each recitation of “shaft” should likely read “mechanical lock shaft” to ensure that the recited “shaft” is not confused with any of the other recited shafts (i.e.: elongate shaft, bendable/flexible shaft/etc.)
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-8, 11-12, and 25-27 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation "the bendable shaft" in lines 11-13. There is insufficient antecedent basis for this limitation in the claim. Thus, it is unclear to the examiner if the “the bendable shaft” in lines 11-13 should read “the [[bendable]] flexible shaft” to refer to the shaft structure as previously recited in the claim language or if lines 11-13 should read “[[the]] a bendable shaft” to introduce a new shaft structure. In view of Applicant disclosure, it seems that the flexible shaft and bendable shaft refer to the same shaft structure (see at least [0091] in the current Application’s PGPUB) and therefore the examiner will interpret each recitation of “bendable shaft” to be “flexible shaft” to provide proper antecedent basis for the term in alignment with Applicant disclosure.
Due to claim dependency from claim 1, claims 2-8, 11-12, and 25-27 are subsequently rejected under 112b.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 11-12, 14, 17-20, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Terliuc et al. (U.S. PGPUB No. 2013/0023920), hereinafter Terliuc, in view of Fonger et al. (U.S. PGPUB No. 2017/0319233), hereinafter Fonger, and Ohshiro (U.S. Patent No. 4,040,413).
Regarding claim 1, Terliuc discloses an instrument port comprising:
an elongated shaft (334, see FIG. 3A) having proximal (shaft 334 terminating at handle 310) and distal ends (shaft portion distally located of handle 310 but terminating before very distal tip 270 of device) and extending along a shaft axis (horizontal axis through 334 in the state such as seen in FIG. 2A),
a flexible shaft (314) attached to the distal end of the elongated shaft (334), the flexible shaft (314) configured to bend only within a pivot plane (see ‘Modified FIG. 3A’ below, 314 bends upward/ downward within pivot plane as shown, aligning with Applicant disclosure in [0104])
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that is defined by the shaft axis (see ‘Modified FIG. 3A’’ above) and a pivot axis (see ‘Modified FIG. 3A’’ above) that is orthogonal to the shaft axis (pivot axis orthogonal to shaft axis and the pivot plane ‘defined by’ those axes are shown in ‘Modified FIG. 3A’ above in alignment with as much as is disclosed by Applicant in [0104] and FIG. 12 of the current Application);
a steerable tip (370, see [0122]: bendable section includes tip 370 and therefore the selective bending of 314 steers tip, see [0118]) attached to (see [0122]: bendable section includes tip 370 and therefore 370 must be attached to the shaft) the distal end (between 310 and 370) of the shaft (334), the steerable tip (370) extending along a tip axis (vertical axis through tip 370, see ‘Modified FIG. 3A’ above, in alignment with the tip axis as disclosed by Applicant in [0106] and FIG.13 of the current Application);
a handle (310) attached to the proximal end (shaft 334 terminating at handle 310) of the elongated shaft (334), the handle (310) including a control mechanism (handle knobs 324 & 326, see [0116]) in mechanical communication with the flexible shaft (314, see [0118]: “Bending section 314 includes a selectably bendable reinforcement mesh 342 which is selectably bendable in response to operator manipulation of steering knobs 324 and 326”) to adjust a customizable angle (see ‘Modified FIG. 3Ai’ below) of the steerable tip (370),
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the customizable angle (see ‘Modified FIG. 3Ai’ above) measured between the shaft axis and the tip axis (customizable angle shown above is ‘measured’ the same way according to as much as is disclosed by Applicant in FIG. 13 and [0106] of the current Application), and
when the [[bendable]] flexible shaft (314) is in an unbent state (see [0118]: 314 is a “selectably” bendable section and thus has an “unbent” configuration and “bent” configuration as seen in FIG. 3A. See [0102] describing the selectably bendable section 214, similar to 314, but showing the unbent state in FIG. 2A):
the [[bendable]] flexible shaft (314) extends along (in an unbent state, such as shown with shaft 214 in FIG. 2A) the shaft axis (horizontal axis through 334), and
the customizable angle is 0° (bendable shaft is aligned with/ extends along the shaft axis and thus the angle between the bendable shaft axis and the shaft axis MUST be 0° in order for the bendable shaft to extend therealong, such as seen for clarity in FIG.2A with the bendable shaft 214);
a working tube (322) disposed in (see [0116-0117]) the elongated shaft (334) and flexible shaft (314, see 322 in Section A-A view shown within shaft portion 344 of 314 and see [0119]), the working tube (322) forming a working channel to receive a medical instrument (see [0116-0117]: 322 described as instrument “channel” for receiving instruments other than fiber bundle 336 already disposed within tube); and
an offset balloon (354) attached to the distal end (see [0121]: balloon 354 sealingly mounted over shaft 334 at distal end as shown in FIG. 3A) of the elongated shaft (334), the offset balloon (354) having a continuous outer circumference (see FIG. 3A and [0121]: circumference of balloon traceable without breaks along 354), wherein the offset balloon (354) comprises an inflated state and a deflated state (see [0123-0124]: balloon is inflatable/deflatable and therefore has an inflated state and a deflated state), wherein in the inflated state (as shown in FIG. 3A) the offset balloon (354) is inflated with respect to the elongated shaft (334) lying in an inflation plane (longitudinal plane passing through shaft axis, in alignment with applicant disclosure in at least FIG. 5 and [0095]), the inflation plane being perpendicular to the pivot plane (longitudinal plane of inflation plane inherently perpendicular to vertical/up/down pivot plane), wherein the flexible shaft (314) is configured to only bend in a direction nonparallel to the inflation plane (see [0118]: 314 “selectably” bendable and therefore is “configured to” only bend in a direction nonparallel to the inflation plane based on user control), and wherein, in the inflated state (as shown in FIG. 3A), the offset balloon (354) has a height (see ‘Modified FIG. 3Aii’ below),
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measured with respect to a vertical axis that is orthogonal to the shaft axis (see ‘Modified FIG. 3Aii’ above), and a bend distance (see ‘Modified FIG. 3Aii’ above), measured from the distal end of the steerable tip (370) to an external surface on the distal end (between 310 and 370) of the elongated shaft (334, see ‘Modified FIG. 3Aii’ above).
Terliuc is silent to the handle control mechanism comprising specifically “a lever”, “wherein the customizable angle is within a range of 0° to 90°,” wherein in the inflated state, the offset balloon is “radially asymmetrically” inflated, the balloon height “that is greater than” the bend distance “when the customizable angle is 90°.”
However, Fonger teaches an instrument port (see FIG. 18) with a handle comprising a lever (51/52, see [0069]) that controls a flexible shaft (20, see [0069]) including a steerable tip (see [0069]: distal tip of shaft 20 is manually articulable and see [0072]: distal tip 50 is deflectable) and a customizable angle (see minimum angle of 70degrees as shown in FIG. 18 and see [0069] for other customizable angles) measured between a shaft axis (horizontal line shown in FIG. 18 that extends through shaft, see ‘Modified FIG. 18’ below for clarity)
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and a tip axis (horizontal line shown in FIG. 18 that extends through tip 50, see ‘Modified FIG. 18’ above for clarity), wherein the customizable angle (see FIG. 18) is within a range of 0° to 90° (see [0069]: deflectable angle up to 90 degrees).’
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date, to have substituted the control mechanism formed of knobs on the handle disclosed in Terliuc with the control mechanism formed of a lever on a handle as taught in Fonger. A person of ordinary skill in the art would have been motivated to make this modification because it is a simple substitution of one known element (a handle with a knob control mechanism disclosed in Terliuc) for another known element (a handle with a lever control mechanism taught in Fonger) in the art to obtain the predictable result of articulating a flexible shaft at the distal end of an elongated shaft of an instrument port (see MPEP § 2143.I.B), thus achieving the handle control mechanism comprising specifically “a lever”.
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the customizable angle of the flexible shaft disclosed in Terliuc to be within a range of 0° to 90° as taught by Fonger for the purpose of providing the distal tip with quick and accurate device positioning closer to the area of treatment (see [0069-0070]), thus achieving “wherein the customizable angle is within a range of 0° to 90°”.
Terliuc in view of Fonger remain silent to wherein in the inflated state, the offset balloon is “radially asymmetrically” inflated, the balloon height “that is greater than” the bend distance “when the customizable angle is 90°.”
However Oshiro teaches an instrument port (see FIG. 4) comprising an elongated shaft (42), a steerable tip (41b, see col. 4 line 6: sleeve 41 can be bent), and an offset balloon (44) with an inflated state (see FIG.4 and col. 4 line 4: “the balloon 44 is inflated” and thus has inflated state) and the offset balloon being radially asymmetrically (balloon 44 inflated on one side of shaft axis) inflated with respect to the shaft axis (horizontal axis extending through shaft 42), wherein, in the inflated state (as shown in FIG. 4), the offset balloon (44) has a height (see ‘Modified FIG. 4’ below),
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measured with respect to a vertical axis that is orthogonal to the shaft axis (see ‘Modified FIG. 4’ above), that is greater than (see measured height of balloon larger than the bend distance as shown in ‘Modified FIG. 4’ above) a bend distance (see ‘Modified FIG. 4’ above), measured from the distal end (see ‘Modified FIG. 4’ above) of the steerable tip (41b) to an external surface (see ‘Modified FIG. 4’ above) on a distal end (portion of shaft distal of break shown in FIG. 4—distal end shown in ‘Modified FIG. 4’ above) of the elongated shaft (42) when the customizable angle is 90° (as seen in ‘Modified FIG. 4’ above, the balloon height is greater than the bend distance through 90° and thus MUST also have a balloon height greater than the bend distance when the customizable angle is 90° in order to enable bending of the shaft through 90° and into the position shown in ‘Modified FIG. 4’ above).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the inflatable balloon disclosed in Terliuc to be radially asymmetrically inflated as taught by Ohshiro for the purpose of expanding the body cavity in one direction to enlarge the field of view for the steerable tip (see col. 4 line 1-16), thus achieving wherein in the inflated state, the offset balloon is “radially asymmetrically” inflated with respect to the shaft axis.
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the balloon height when the customizable angle is 90° taught by Terliuc in view of Fonger to be greater than the bend distance of the bendable shaft as taught by Ohshiro for the purpose of expanding the body cavity to make a large space that allows for bending of the shaft in the same direction in order to obtain a large field of view (see col. 4 lines 1-11), thus achieving the balloon height “that is greater than” the bend distance “when the customizable angle is 90°.”
Regarding claim 11, the modified system of Terliuc teaches the instrument port of claim 1, and Terliuc further discloses wherein: the elongated shaft (334, see FIG. 3A) is flexible (see [0117]: shaft designed to prevent collapse during bending of portion 312 of elongated shaft 334), the elongated shaft (334) has a flexed state (see [0117], such as if the shaft 312 encounters an obstacle or contacts vasculature to curve) and an unflexed state (no contact with obstacle or vasculature), and in the unflexed state (no contact with obstacle or vasculature), the elongated shaft extends along the shaft axis (along longitudinal axis as seen in FIG. 3A).
Regarding claim 12, the modified system of Terliuc teaches the instrument port of claim 11, and Terliuc further discloses when the customizable angle is adjusted (as in FIG. 3A), the elongated shaft stays in the unflexed state (along longitudinal axis as seen in FIG. 3A without contacting obstacle or vasculature).
Regarding claim 14, Terliuc discloses an instrument port comprising:
an elongated shaft (334, see FIG. 3A) having proximal (shaft 334 terminating at handle 310) and distal ends (shaft portion distally located of handle 310 but terminating before very distal tip 270 of device) and extending along a shaft axis (horizontal axis through 334 in the state such as seen in FIG. 2A),
a flexible shaft (314) attached to the distal end of the elongated shaft (334), the flexible shaft (314) configured to bend only within a pivot plane (see ‘Modified FIG. 3A’ below, 314 bends upward/ downward within pivot plane as shown, aligning with Applicant disclosure in [0104])
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that is defined by the shaft axis (see ‘Modified FIG. 3A’’ above) and a pivot axis (see ‘Modified FIG. 3A’’ above) that is orthogonal to the shaft axis (pivot axis orthogonal to shaft axis and the pivot plane ‘defined by’ those axes are shown in ‘Modified FIG. 3A’ above in alignment with as much as is disclosed by Applicant in [0104] and FIG. 12 of the current Application);
a steerable tip (370, see [0122]: bendable section includes tip 370 and therefore the selective bending of 314 steers tip, see [0118]) attached to (see [0122]: bendable section includes tip 370 and therefore 370 must be attached to the shaft) the distal end (between 310 and 370) of the shaft (334), the steerable tip (370) extending along a tip axis (vertical axis through tip 370, see ‘Modified FIG. 3A’ above, in alignment with the tip axis as disclosed by Applicant in [0106] and FIG.13 of the current Application), the steerable tip (370) comprising a customizable angle (see ‘Modified FIG. 3Ai’ below),
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the customizable angle (see ‘Modified FIG. 3Ai’ above) measured between the shaft axis and the tip axis (customizable angle shown above is ‘measured’ the same way according to as much as is disclosed by Applicant in FIG. 13 and [0106] of the current Application), and
when the bendable shaft (314) is in an unbent state (see [0118]: 314 is a “selectably” bendable section and thus has an “unbent” configuration and “bent” configuration as seen in FIG. 3A. See [0102] describing the selectably bendable section 214, similar to 314, but showing the unbent state in FIG. 2A):
the bendable shaft (314) extends along (in an unbent state, such as shown with shaft 214 in FIG. 2A) the shaft axis (horizontal axis through 334), and
the customizable angle is 0° (bendable shaft is aligned with/ extends along the shaft axis and thus the angle between the bendable shaft axis and the shaft axis MUST be 0° in order for the bendable shaft to extend therealong, such as seen for clarity in FIG.2A with the bendable shaft 214);
a handle (310) attached to the proximal end (shaft 334 terminating at handle 310) of the elongated shaft (334), the handle (310) including a control mechanism (handle knobs 324 & 326, see [0116]) in mechanical communication with the flexible shaft (314, see [0118]: “Bending section 314 includes a selectably bendable reinforcement mesh 342 which is selectably bendable in response to operator manipulation of steering knobs 324 and 326”) to adjust the customizable angle (see [0118]: handle controls bending of 314 which therefore adjusts the customizable angle),
a working tube (322) disposed in (see [0116-0117]) the elongated shaft (334) and flexible shaft (314, see 322 in Section A-A view shown within shaft portion 344 of 314 and see [0119]), the working tube (322) forming a working channel to receive a medical instrument (see [0116-0117]: 322 described as instrument “channel” for receiving instruments other than fiber bundle 336 already disposed within tube); and
an offset balloon (354) attached to the distal end (see [0121]: balloon 354 sealingly mounted over shaft 334 at distal end as shown in FIG. 3A) of the elongated shaft (334), the offset balloon (354) having a continuous outer circumference (see FIG. 3A and [0121]: circumference of balloon traceable without breaks along 354), wherein the offset balloon (354) comprises an inflated state and a deflated state (see [0123-0124]: balloon is inflatable/deflatable and therefore has an inflated state and a deflated state), wherein in the inflated state (as shown in FIG. 3A) the offset balloon (354) is inflated with respect to the elongated shaft (334) lying in an inflation plane (longitudinal plane passing through shaft axis, in alignment with applicant disclosure in at least FIG. 5 and [0095]), the inflation plane being perpendicular to the pivot plane (longitudinal plane of inflation plane inherently perpendicular to vertical/up/down pivot plane), wherein the flexible shaft (314) is configured to only bend in a direction nonparallel to the inflation plane (see [0118]: 314 “selectably” bendable and therefore is “configured to” only bend in a direction nonparallel to the inflation plane based on user control), and wherein in the inflated state (as shown in FIG. 3A), the offset balloon (354) has a height (see ‘Modified FIG. 3Aii’ below),
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measured with respect to a vertical axis that is orthogonal to the shaft axis (see ‘Modified FIG. 3Aii’ above), and a bend distance (see ‘Modified FIG. 3Aii’ above), measured from the distal end of the steerable tip (370) to an external surface on the distal end (between 310 and 370) of the elongated shaft (334, see ‘Modified FIG. 3Aii’ above).
Terliuc is silent to “wherein the customizable angle is within a range of -90° to 90°.” Terliuc is silent to the internal mechanisms of the handle, such as:
“the handle including a spindle in mechanical communication with the flexible shaft to adjust the customizable angle a mechanical lock having a locked state and an unlocked state, wherein the customizable angle of the steerable tip is locked while the mechanical lock is in the locked state, the mechanical lock comprising:
a shaft having a shaft axis extending through the spindle:
a locking housing comprising a locking channel slidably coupled to the shaft, the locking channel comprising:
a locked side; and
an unlocked side:
wherein the locking channel transitions between the locked state and the unlocked state by sliding linearly in a direction perpendicular to the shaft axis,
wherein the mechanical lock is in the locked state when the shaft slides to the locked side, and
wherein the mechanical lock is in the unlocked state when the shaft slides to the unlocked side;”.
Terliuc is silent to wherein in the inflated state, the offset balloon is “radially asymmetrically” inflated, the balloon height “that is greater than” the bend distance “when the customizable angle is 90°.”
However, Fonger teaches an instrument port (see FIG. 18) with a flexible shaft (20, see [0069]) including a steerable tip (see [0069]: distal tip of shaft 20 is manually articulable and see [0072]: distal tip 50 is deflectable) and a customizable angle (see minimum angle of 70degrees as shown in FIG. 18 and see [0069] for other customizable angles) measured between a shaft axis (horizontal line shown in FIG. 18 that extends through shaft, see ‘Modified FIG. 18’ below for clarity)
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and a tip axis (horizontal line shown in FIG. 18 that extends through tip 50, see ‘Modified FIG. 18’ above for clarity), wherein the customizable angle (see FIG. 18) is within a range of -90° to 90° (see [0069]: deflectable angle up to 90 degrees).
Fonger further teaches the instrument port comprising a handle (30, see [0069]), the handle (30) including a spindle (a central shaft for rotating a component) in mechanical communication with the flexible shaft (20) to adjust the customizable angle (see [0072]: levers 51/52 articulate flexible shaft via pull wires and therefore there must be a spindle/ central shaft for allowing rotation via the push & pull of wires by levers 51/52 to adjust flexible shaft articulation) a mechanical lock (53) having a locked state (see text “LOCK” in FIG. 18 and [0069]: 53 locks distal end in specific position) and an unlocked state (see text “UNLOCK” in FIG. 18), wherein the customizable angle of the steerable tip (see ‘Modified FIG. 18’ above) is locked while the mechanical lock (53) is in the locked state (as described in [0069]), the mechanical lock (53) comprising:
a shaft (see cylindrical peg extending from handle to form toggle switch in ‘Modified FIG. 18’ above) having a shaft axis (see ‘Modified FIG. 18i’ below)
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extending through the spindle (an axis extends infinitely and thus extends “through” the spindle located within the handle);
a locking housing (see portion of handle within rectangle in ‘Modified FIG. 18’ above) comprising a locking channel (see ‘Modified FIG. 18i’ above—the channel/ slot in which shaft 53 is disposed) slidably coupled (as depicted, shaft 53 must slide/ toggle within channel as shown in ‘Modified FIG. 18i’ above) to the shaft (cylindrical shape of 53), the locking channel (channel where 53 is disposed, see ‘Modified FIG. 18i’ above) comprising:
a locked side (see “right” side with text “LOCK” in FIG. 18); and
an unlocked side (see “left” side with text “UNLOCK” in FIG. 18);
wherein the locking channel (see ‘Modified FIG. 18i’ above) transitions between the locked state and the unlocked state by sliding linearly in a direction perpendicular to the shaft axis (locking channel transitions as control 53 formed of shaft toggles between locked and unlocked positions shown in FIG. 18. Thus, in reference to the shaft axis, the locking channel is the structure that slides linearly “in a direction perpendicular to the shaft axis”. See ‘Modified FIG. 18i’ above for direction perpendicular to shaft axis),
wherein the mechanical lock is in the locked state when the shaft slides to the locked side (see FIG. 18 and [0069]), and
wherein the mechanical lock is in the unlocked state when the shaft slides to the unlocked side (see FIG. 18 and [0069]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the customizable angle of the flexible shaft disclosed in Terliuc to be within a range of -90° to 90° as taught by Fonger for the purpose of providing the distal tip with quick and accurate device positioning closer to the area of treatment (see [0069-0070]), thus achieving “wherein the customizable angle is within a range of -90° to 90°.”
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the handle control mechanism in mechanical communication with the flexible shaft for adjusting the customizable angle of the steerable tip disclosed in Terliuc with the handle control mechanism including a spindle and mechanical lock for adjusting the customizable angle as taught by Fonger for the purpose of providing the control mechanism with a mechanical lock and articulation mechanism that can lock the distal end of the device in place (see [0069]), to facilitate quick and accurate device positioning and treatment (see [0070]), thus achieving the internal mechanisms of the handle, such as:
“the handle including a spindle in mechanical communication with the flexible shaft to adjust the customizable angle a mechanical lock having a locked state and an unlocked state, wherein the customizable angle of the steerable tip is locked while the mechanical lock is in the locked state, the mechanical lock comprising:
a shaft having a shaft axis extending through the spindle:
a locking housing comprising a locking channel slidably coupled to the shaft, the locking channel comprising:
a locked side; and
an unlocked side:
wherein the locking channel transitions between the locked state and the unlocked state by sliding linearly in a direction perpendicular to the shaft axis,
wherein the mechanical lock is in the locked state when the shaft slides to the locked side, and
wherein the mechanical lock is in the unlocked state when the shaft slides to the unlocked side;”.
Terliuc in view of Fonger remain silent to wherein in the inflated state, the offset balloon is “radially asymmetrically” inflated, the balloon height “that is greater than” the bend distance “when the customizable angle is 90°.”
However Oshiro teaches an instrument port (see FIG. 4) comprising an elongated shaft (42), a steerable tip (41b, see col. 4 line 6: sleeve 41 can be bent), and an offset balloon (44) with an inflated state (see FIG.4 and col. 4 line 4: “the balloon 44 is inflated” and thus has inflated state) and the offset balloon being radially asymmetrically (balloon 44 inflated on one side of shaft axis) inflated with respect to the shaft axis (horizontal axis extending through shaft 42), wherein, in the inflated state (as shown in FIG. 4), the offset balloon (44) has a height (see ‘Modified FIG. 4’ below),
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measured with respect to a vertical axis that is orthogonal to the shaft axis (see ‘Modified FIG. 4’ above), that is greater than (see measured height of balloon larger than the bend distance as shown in ‘Modified FIG. 4’ above) a bend distance (see ‘Modified FIG. 4’ above), measured from the distal end (see ‘Modified FIG. 4’ above) of the steerable tip (41b) to an external surface (see ‘Modified FIG. 4’ above) on a distal end (portion of shaft distal of break shown in FIG. 4—distal end shown in ‘Modified FIG. 4’ above) of the elongated shaft (42) when the customizable angle is 90° (as seen in ‘Modified FIG. 4’ above, the balloon height is greater than the bend distance through 90° and thus MUST also have a balloon height greater than the bend distance when the customizable angle is 90° in order to enable bending of the shaft through 90° and into the position shown in ‘Modified FIG. 4’ above).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the inflatable balloon disclosed in Terliuc to be radially asymmetrically inflated as taught by Ohshiro for the purpose of expanding the body cavity in one direction to enlarge the field of view for the steerable tip (see col. 4 line 1-16), thus achieving wherein in the inflated state, the offset balloon is “radially asymmetrically” inflated with respect to the shaft axis.
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the balloon height when the customizable angle is 90° taught by Terliuc in view of Fonger to be greater than the bend distance of the bendable shaft as taught by Ohshiro for the purpose of expanding the body cavity to make a large space that allows for bending of the shaft in the same direction in order to obtain a large field of view (see col. 4 lines 1-11), thus achieving the balloon height “that is greater than” the bend distance “when the customizable angle is 90°.”
Regarding claim 17, the modified system of Terliuc teaches the instrument port of claim 14, and Terliuc further discloses wherein: the first (bottom side of shaft 314, see FIG.3A) and second (top side of shaft 314, see FIG.3A) sides of the flexible shaft (3145) comprise internal surfaces (i.e.: internal surfaces of 344 as seen in SECTION A-A of FIG. 3A) disposed at a distal end (as in SECTION A-A) of the flexible shaft (314), and the pivot axis passes through the internal surfaces of the first and second sides (tip bends in direction of internal surfaces and thus aligns with Applicant disclosure of “pivot axis passes through the internal surfaces” in as much as is disclosed by Applicant such as in FIG. 14 and [0109]).
Regarding claim 18, the modified system of Terliuc teaches the instrument port of claim 17, but Terliuc is silent to “wherein: the first and second levers are mechanically coupled to first and second wire ropes, respectively, and the first and second wire ropes comprise the first and second wires, respectively.”
However, Fonger teaches the instrument port comprising a handle (30, see FIG. 18 and [0069]), the handle having a first (51) and second (52) lever, wherein: the first and second levers are mechanically coupled to first and second wire ropes (see [0072]: 51/52 attached to distal end by pull wires==wire ropes. Thus, each respective lever attached to a single or first and second wires), respectively, and the first and second wire ropes comprise the first and second wires, respectively (see [0072]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the articulation mechanism of the handle disclosed in Terliuc to include first and second levers mechanically coupled to first and second wire ropes comprising first and second wires as taught by Fonger for the purpose of deflecting the distal end of the shaft in a single plane (i.e.: up/down as in FIG. 18) (see [0072]), thus achieving “wherein: the first and second levers are mechanically coupled to first and second wire ropes, respectively, and the first and second wire ropes comprise the first and second wires, respectively.”
Regarding claim 19, the modified system of Terliuc teaches the instrument port of claim 17, but Terliuc is silent to “wherein the first and second levers are mechanically coupled to a spindle disposed in the handle.”
However, Fonger teaches the instrument port comprising a handle (30, see FIG. 18 and [0069]), the handle (30) including the first (51) and second (52) levers, wherein the first and second levers are mechanically coupled to a spindle (a central shaft for rotating a component, see [0072]: levers 51/52 articulate flexible shaft via pull wires and therefore there must be a spindle/ central shaft for allowing rotation via the push & pull of wires by levers 51/52 to adjust flexible shaft articulation) disposed in the handle (30).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the handle control mechanism in mechanical communication with the flexible shaft for adjusting the customizable angle of the steerable tip disclosed in Terliuc with the handle control mechanism including a lever mechanically coupled to a spindle disposed in the handle for adjusting the customizable angle as taught by Fonger for the purpose of facilitating quick and accurate device positioning and treatment (see [0070]), such as by having the extending levers that are easy to grasp without seeing (in comparison to a flat knob on the side of the device such as disclosed in Terliuc), thus achieving “wherein the first and second levers are mechanically coupled to a spindle disposed in the handle.”
Regarding claim 20, the modified system of Terliuc teaches the instrument port of claim 19, but Terliuc is silent to “wherein: the first and second wires are attached to the spindle, and the spindle is configured to rotate in a first direction to pull the end of the first wire towards the proximal end of the elongated shaft when the first lever is pulled, thereby causing the flexible shaft to bend in the first direction, and the spindle is configured to rotate in a second direction to pull the end of the second wire towards the proximal end of the elongated shaft when the second lever is pulled, thereby causing the flexible shaft to bend in the second direction.”
However, Fonger teaches the instrument port comprising a handle (30, see FIG. 18 and [0069]), the handle having a first (51) and second (52) lever, wherein: the first and second levers are mechanically coupled to first and second wire ropes (see [0072]: 51/52 attached to distal end by pull wires==wire ropes. Thus, each respective lever attached to a single or first and second wires), respectively, and the first and second wire ropes comprise the first and second wires, respectively (see [0072]), wherein: the first and second wires are attached to the spindle (see [0072]), and the spindle is configured to rotate (see [0069] and [0072]) in a first direction (see arrow shown on lever 52) to pull the end of the first wire towards the proximal end of the elongated shaft when the first lever is pulled (see [0072]: pull wires are attached at distal end and thus must be pulled “toward” distal end under pull force), thereby causing the flexible shaft to bend in the first direction (i.e.: upward, see [0072]), and the spindle is configured to rotate in a second direction (direction opposite of arrow shown on lever 52) to pull the end of the second wire towards the proximal end of the elongated shaft when the second lever is pulled, thereby causing the flexible shaft to bend in the second direction (i.e.: downward, see [0072]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the articulation mechanism of the handle disclosed in Terliuc to include first and second levers mechanically coupled to first and second wire ropes comprising first and second wires attached to a rotatable spindle configured to rotate in separate directions to articulate the flexible shaft in two directions as taught by Fonger for the purpose of deflecting the distal end of the shaft in a single plane (i.e.: up/down as in FIG. 18) (see [0072]), thus achieving “wherein: the first and second wires are attached to the spindle, and the spindle is configured to rotate in a first direction to pull the end of the first wire towards the proximal end of the elongated shaft when the first lever is pulled, thereby causing the flexible shaft to bend in the first direction, and the spindle is configured to rotate in a second direction to pull the end of the second wire towards the proximal end of the elongated shaft when the second lever is pulled, thereby causing the flexible shaft to bend in the second direction.”
Regarding claim 24, the modified system of Terliuc teaches the instrument port of claim 14, and Terliuc further discloses wherein the customizable angle (as shown in FIG. 3A) is adjustable (see [0117-0118]) while a flexed position and a flexed orientation of the elongated shaft (334) is maintained (see [0117]: shaft designed to prevent collapse during bending).
Claims 2-3 and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Terliuc in view of Fonger and Ohshiro as applied to claims 1 and 14, respectively, above, and further in view of Cardinale et al. (U.S. Patent No. 10,610,345), hereinafter Cardinale.
Regarding claims 2 and 15, the modified system of Terliuc teaches the instrument port of claims 1 and 14, respectively, and Terliuc further discloses wherein in an unbent state (see [0118]: 314 is a “selectably” bendable section and thus has an “unbent” configuration and “bent” configuration as seen in FIG. 3A. See [0102] describing the selectably bendable section 214, similar to 314, but showing the unbent state in FIG. 2A) the
flexible shaft (314) extends along (in an unbent state, such as shown with shaft 214 in FIG. 2A) the shaft axis (horizontal axis through 334).
Terliuc is silent to the flexible shaft includes: “a plurality of mechanical rings concentrically disposed along the shaft axis, the plurality of mechanical rings including neighboring mechanical ring pairs, and each neighboring mechanical ring pair is mechanically coupled by a pair of mechanical links, wherein a respective third axis passes through each pair of mechanical links, the respective third axis orthogonal to the shaft and pivot axes.”
However, Cardinale teaches an instrument port (see col. 4 lines 28-37) with an elongated shaft (602, see FIG. 17A) with a steerable tip (642G, see col. 15 lines 20-22: 642G is distal most member) attached to a distal end (rightward in FIG. 17A) of a flexible shaft (602), a plurality of mechanical rings (642A-F) concentrically disposed (see FIG. 17A) along the shaft axis (longitudinal axis of shaft), the plurality of mechanical rings (642A-F) including neighboring mechanical ring pairs (each group of 2 in 642A-F, such as 642B/C, 642C/D, etc.), and each neighboring mechanical ring pair (each group of 2 in 642A-F, such as 642B/C, 642C/D, etc.) is mechanically coupled by a pair (link provided on each side of ring and therefore is a “pair”) of mechanical links (676, see FIG. 15B), wherein a respective third axis (axis through link 676, aligning with applicant disclosure of third axis in FIG. 12 and [0103] of the current application) passes through each pair of mechanical links (676), the respective third axis orthogonal to the shaft and pivot axes (third axis through link 676 is orthogonal to shaft and pivot axes in as much as is disclosed by Applicant in FIG. 12 and [0103-0104] of the current Application).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the flexible shaft articulation mechanism disclosed in Terliuc to include a plurality of mechanical neighboring link and ring pairs as taught by Cardinale for the purpose of forming the device with two discrete articulable positions which simplifies the device design and operation (see col. 4 line 59-col. 5 line 4 and col. 5 line 11-19), or to form the bendable shaft as independent links that allow for ease of manufacturing (see col. 5 lines 20-22), thus achieving the flexible shaft includes: “a plurality of mechanical rings concentrically disposed along the shaft axis, the plurality of mechanical rings including neighboring mechanical ring pairs, and each neighboring mechanical ring pair is mechanically coupled by a pair of mechanical links, wherein a respective third axis passes through each pair of mechanical links, the respective third axis orthogonal to the shaft and pivot axes.”
Regarding claims 3 and 16, the modified system of Terliuc teaches the instrument port of claims 2 and 15, respectively, but Terliuc is silent to “wherein the pairs of mechanical links mechanically restrict a bending direction of the flexible shaft to the pivot plane.”
However, Cardinale teaches an instrument port (see col. 4 lines 28-37) with an elongated shaft (602, see FIG. 17A) with a steerable tip (642G, see col. 15 lines 20-22: 642G is distal most member) attached to a distal end (rightward in FIG. 17A) of a flexible shaft (602), the flexible shaft comprising a plurality of mechanical rings (642A-F) and links (676, see FIG. 15B), wherein the pairs of mechanical links (676) mechanically restrict a bending direction (up/down) of the flexible shaft to a pivot plane (see ‘Modified FIG. 17A’ below and col. 15 line 9-14: shaft has straight and articulated configuration and does not teach other articulations, such as a left/ right bending direction--compared to up/down along “pivot axis” as labeled in ‘Modified FIG. 17A’ below. Further, see col 15 line 55-col. 16 line 3: bending/articulation must be actuated and thus is controllable. Therefore, the links restrict the flexibility within the pivot plane.).
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Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the flexible shaft articulation mechanism disclosed in Terliuc to include a plurality of mechanical neighboring link and ring pairs as taught by Cardinale for the purpose of forming the device with two discrete articulable positions which simplifies the device design and operation (see col. 4 line 59-col. 5 line 4 and col. 5 line 11-19), or to form the bendable shaft as independent links that allow for ease of manufacturing (see col. 5 lines 20-22), thus achieving “wherein the pairs of mechanical links mechanically restrict a bending direction of the flexible shaft to the pivot plane.”
Claims 4-8 are rejected under 35 U.S.C. 103 as being unpatentable over Terliuc in view of Fonger and Ohshiro as applied to claim 1 above, and further in view of Mori (U.S. PGPUB No. 2017/0354463).
Regarding claim 4, the modified system of Terliuc teaches the instrument port of claim 1, but Terliuc is silent to “wherein the lever is mechanically coupled to a wire that extends to a distal end of the flexible shaft, the wire attached to an internal surface of the flexible shaft, the pivot axis passing through the internal surface.”
However, Fonger teaches an instrument port (see FIG. 18) with a handle comprising a lever (51/52, see [0069]) that controls a flexible shaft (20, see [0069]) along a pivot axis (see [0072]: up/down bending in single plane comprising a vertical pivot axis), wherein the lever (51/52) is mechanically coupled to a wire that extends to a distal end of the flexible shaft (see [0072]: 51/52 attached to distal end by pull wires. Thus, each respective lever attached to a single wire), the wire attached to a surface (see [0072]: “respective opposite sides”==a surface) the flexible shaft (50), the pivot axis passing through the surface (see [0072], aligning with as much as is disclosed by Applicant in FIG. 14 and [0109] of the current application).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the articulation mechanism of the handle disclosed in Terliuc to include a lever mechanically coupled to a wire that extends to a distal end of the flexible shaft as taught by Fonger for the purpose of deflecting the distal end of the shaft in a single plane (i.e.: up/down as in FIG. 18) (see [0072]), thus achieving “wherein the lever is mechanically coupled to a wire that extends to a distal end of the flexible shaft, the wire attached to” a “surface of the flexible shaft, the pivot axis passing through the” “surface.”
Terliuc in view of Fonger remain silent to the wire attached to “an internal surface” of the flexible shaft.
However, Mori teaches an instrument port (see FIG. 10) comprising a lever (knobs on rotation mechanism 25, see [0064]) for bending a flexible shaft (10, see [0064]), wherein the lever (knobs of 25) is mechanically coupled to a wire (wire 41 and wire 42 connect to lever, see [0066-0068]) that extends to a distal end of the flexible shaft (see FIG. 8 and [0065]), the wire (41/42) attached to an internal surface of the flexible shaft (see FIG. 8 and [0065]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the lever mechanically coupled to the distal end of the flexible shaft by a wire attached to a surface of the flexible shaft taught by Terliuc in view of Fonger to have the wire attached to specifically an internal surface of the distal end of the flexible shaft as taught by Mori for the purpose of protecting the wires within the shaft (compared to wires disposed outside of the shaft), thus achieving the wire attached to “an internal surface” of the flexible shaft.
Alternatively, therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date, to have substituted the lever wire coupled to a surface of the flexible shaft taught by Terliuc in view of Fonger with the lever wire coupled to an internal surface of the flexible shaft as taught in Mori. A person of ordinary skill in the art would have been motivated to make this modification because it is a simple substitution of one known element (a lever coupled to a wire by a surface of the distal end of a flexible shaft taught in Terliuc in view of Fonger) for another known element (a lever coupled to a wire by an internal surface of the distal end of a flexible shaft taught in Mori) in the art to obtain the predictable result of bending the distal end of a shaft by way of a lever coupled to a wire (see MPEP § 2143.I.B).
Regarding claim 5, the modified system of Terliuc teaches the instrument port of claim 4, but Terliuc is silent to “wherein the lever is mechanically coupled to a wire rope that extends to the distal end of the flexible shaft, the wire rope comprising the wire.”
However, Fonger teaches an instrument port (see FIG. 18) with a handle comprising a lever (51/52, see [0069]) that controls a flexible shaft (20, see [0069]) along a pivot axis (see [0072]: up/down bending in single plane comprising a vertical pivot axis), wherein the lever (51/52) is mechanically coupled to a wire that extends to a distal end of the flexible shaft (see [0072]: 51/52 attached to distal end by pull wires. Thus, each respective lever attached to a single wire), wherein the lever (51/52) is mechanically coupled to a wire rope (definition of rope is a long cord and therefore a pullwire meets the definition of a wire rope) that extends to the distal end of the flexible shaft (see [0072]: “The lever arms 51, 52 attach to the respective opposite sides of the distal top 50 via pull wires”), the wire rope comprising the wire (see [0072]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the articulation mechanism of the handle disclosed in Terliuc to include a lever mechanically coupled to a wire rope comprising a wire that extends to a distal end of the flexible shaft as taught by Fonger for the purpose of deflecting the distal end of the shaft in a single plane (i.e.: up/down as in FIG. 18) (see [0072]), thus achieving “wherein the lever is mechanically coupled to a wire rope that extends to the distal end of the flexible shaft, the wire rope comprising the wire.”
Regarding claim 6, the modified system of Terliuc teaches the instrument port of claim 4, but Terliuc is silent to “wherein the lever is mechanically coupled to a spindle disposed in the handle.”
However, Fonger teaches the instrument port comprising a handle (30, see FIG. 18 and [0069]), the handle (30) including a lever (levers 51/52), wherein the lever (51/52) is mechanically coupled to a spindle (a central shaft for rotating a component, see [0072]: levers 51/52 articulate flexible shaft via pull wires and therefore there must be a spindle/ central shaft for allowing rotation via the push & pull of wires by levers 51/52 to adjust flexible shaft articulation) disposed in the handle (30).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the handle control mechanism in mechanical communication with the flexible shaft for adjusting the customizable angle of the steerable tip disclosed in Terliuc with the handle control mechanism including a lever mechanically coupled to a spindle disposed in the handle for adjusting the customizable angle as taught by Fonger for the purpose of facilitating quick and accurate device positioning and treatment (see [0070]), such as by having the extending levers that are easy to grasp without seeing (in comparison to a flat knob on the side of the device such as disclosed in Terliuc), thus achieving “wherein the lever is mechanically coupled to a spindle disposed in the handle.”
Regarding claim 7, the modified system of Terliuc teaches the instrument port of claim 6, but Terliuc is silent to “wherein: the wire is attached to the spindle, and pulling the lever causes the spindle to rotate to pull the wire towards the proximal end of the elongated shaft to thereby cause the flexible shaft to bend in a first direction.”
However, Fonger teaches the instrument port comprising a handle (30, see FIG. 18 and [0069]), the handle (30) including a lever (levers 51/52), wherein the lever (51/52) is mechanically coupled to a spindle (a central shaft for rotating a component, see [0072]: levers 51/52 articulate flexible shaft via pull wires and therefore there must be a spindle/ central shaft for allowing rotation via the push & pull of wires by levers 51/52 to adjust flexible shaft articulation) disposed in the handle (30) wherein: the wire (wires attached to levers 51/52, see [0072]) is attached to the spindle (see [0072]), and pulling (such as in direction of arrow shown on lever 52 in FIG. 18) the lever (52) causes the spindle to rotate to pull the wire towards the proximal end of the elongated shaft to thereby cause the flexible shaft to bend in a first direction (see [0072]: wires fixed at distal end and thus a pulling force MUST pull wire “towards a proximal end”).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the articulation mechanism of the handle disclosed in Terliuc to include a wire coupled to a spindle, where pulling the lever causes the spindle to rotate to pull the wire towards the proximal end of the shaft and bend the shaft in a first direction as taught by Fonger for the purpose of deflecting the distal end of the shaft in a single plane (i.e.: up/down as in FIG. 18) (see [0072]), thus achieving “wherein: the wire is attached to the spindle, and pulling the lever causes the spindle to rotate to pull the wire towards the proximal end of the elongated shaft to thereby cause the flexible shaft to bend in a first direction.”
Regarding claim 8, the modified system of Terliuc teaches the instrument port of claim 7, but Terliuc is silent to “wherein the handle includes a mechanical lock that applies a force against the spindle to set the customizable angle of the flexible shaft.”
However, Fonger teaches the instrument port comprising a handle (30, see [0069]), the handle (30) including a spindle (a central shaft for rotating a component) in mechanical communication with the flexible shaft (20) to adjust the customizable angle (see [0072]: levers 51/52 articulate flexible shaft via pull wires and therefore there must be a spindle/ central shaft for allowing rotation via the push & pull of wires by levers 51/52 to adjust flexible shaft articulation), wherein the handle (30) includes a mechanical lock (53) that applies a force against the spindle to set the customizable angle of the flexible shaft (20, see [0069]: lock must apply a force to spindle allowing rotation of levers 51/52 in order to achieve the locking of the distal end at 70/80/90degrees as described).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the handle control mechanism in mechanical communication with the flexible shaft for adjusting the customizable angle of the steerable tip disclosed in Terliuc with the handle control mechanism including a spindle and mechanical lock for adjusting the customizable angle as taught by Fonger for the purpose of providing the control mechanism with a mechanical lock and articulation mechanism that can lock the distal end of the device in place (see [0069]), to facilitate quick and accurate device positioning and treatment (see [0070]), thus achieving “wherein the handle includes a mechanical lock that applies a force against the spindle to set the customizable angle of the flexible shaft.”
Claims 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Terliuc in view of Fonger and Ohshiro as applied to claim 20 above, and further in view of Mori (U.S. PGPUB No. 2017/0354463).
Regarding claim 21, the modified system of Terliuc teaches the instrument port of claim 20, but Modified Terliuc is silent to “wherein: the spindle is configured to release a first force on the first wire when the spindle is rotated in the second direction, and the spindle is configured to release a second force on the second wire when the spindle is rotated in the first direction.”
However, Mori teaches an instrument port with a handle (20, see FIG. 10) comprising a first and second lever (levers of knob 25, see ‘Modified FIG. 10’ below for clarity)
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mechanically coupled to a spindle (knob 25, see [0064-0068]: knob 25 a spindle according to definition of a spindle being a part that revolves about an axis), wherein: the first and second levers (see ‘Modified FIG.10’ above) are mechanically coupled to (see [0064-0068]) first (41, see FIG.8, 41 is long cord, meeting definition of rope) and second (42, see FIG.8, 42 is long cord, meeting definition of rope) wire ropes, respectively, and the first and second wire ropes comprise first and second wires (see [0064-0068]), wherein: the first (41) and second wires (42) are attached to the spindle (25, see [0066]), and the spindle (25) is configured to rotate in a first direction (A1) to pull the end of the first wire (41) towards the proximal end of the elongated shaft when the first lever is pulled (see [0067]), thereby causing the flexible shaft to bend in a first direction (A), and the spindle (25) is configured to rotate in a second direction (B1) to pull the end of the second wire (42) towards the proximal end of the elongated shaft when the second lever is pulled (see [0068]), thereby causing the flexible shaft to bend in the second direction (B), and wherein: the spindle (25) is configured to release a first force (see [0064-0068]: spindle applies force and is therefore configured to release the force when rotating to deflect the shaft in a different direction) on the first wire (41) when the spindle is rotated in the second direction (B), and the spindle (25) is configured to release a second force on the second wire (42) when the spindle (25) is rotated in the first direction (A).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the spindle of the handle mechanism including a spindle, first and second levers, wire ropes, and wires taught by Modified Terliuc to include the spindle configured to release the forces on the opposite wires when bending in opposite directions as taught by Mori for the purpose of bending the shaft in one direction by activation of one wire and bending the shaft in the opposite direction by activation of a second wire (see [0067-0068]), simplifying device use by only requiring activation of one lever at a time, thus achieving “wherein: the spindle is configured to release a first force on the first wire when the spindle is rotated in the second direction, and the spindle is configured to release a second force on the second wire when the spindle is rotated in the first direction.”
Regarding claim 22, the modified system of Terliuc teaches the instrument port of claim 20, but Terliuc is silent to “wherein the handle includes a mechanical lock that applies a force against the spindle to set the customizable angle of the flexible shaft.”
However, Fonger teaches the instrument port comprising a handle (30, see [0069]), the handle (30) including a spindle (a central shaft for rotating a component) in mechanical communication with the flexible shaft (20) to adjust the customizable angle (see [0072]: levers 51/52 articulate flexible shaft via pull wires and therefore there must be a spindle/ central shaft for allowing rotation via the push & pull of wires by levers 51/52 to adjust flexible shaft articulation), wherein the handle (30) includes a mechanical lock (53) that applies a force against the spindle to set the customizable angle of the flexible shaft (20, see [0069]: lock must apply a force to spindle allowing rotation of levers 51/52 in order to achieve the locking of the distal end at 70/80/90degrees as described).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the handle control mechanism in mechanical communication with the flexible shaft for adjusting the customizable angle of the steerable tip disclosed in Terliuc with the handle control mechanism including a spindle and mechanical lock for adjusting the customizable angle as taught by Fonger for the purpose of providing the control mechanism with a mechanical lock and articulation mechanism that can lock the distal end of the device in place (see [0069]), to facilitate quick and accurate device positioning and treatment (see [0070]), thus achieving “wherein the handle includes a mechanical lock that applies a force against the spindle to set the customizable angle of the flexible shaft.”
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Terliuc in view of Fonger and Ohshiro as applied to claim 1 above, and further in view of Laduca et al. (U.S. PGPUB No. 2018/0344981), hereinafter Laduca.
Regarding claim 25, the modified system of Terliuc teaches the instrument of claim 1, but Modified Terliuc is silent to “wherein the elongated shaft comprises a metal tube, the metal tube defined by a pattern of slits.”
However, Laduca teaches an instrument port (see Fig.1) with an elongated shaft (12), wherein the elongated shaft (12) comprises a metal tube (56, see 56 within shaft 12 in FIG. 5 and see [0069]: 56 can be laser cut hypotube and teaches a nitinol hypotube in [0070]), the metal tube (56) defined by a pattern of slits (see FIG. 7A and [0076]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the elongated shaft disclosed in Terliuc to comprise a metal tube defined by a pattern of slits as taught by Laduca for the purpose of providing the shaft with a designed flexibility zone/direction based on the slit pattern (see [0076-0078]), thus achieving “wherein the elongated shaft comprises a metal tube, the metal tube defined by a pattern of slits”.
Claims 26-27 are rejected under 35 U.S.C. 103 as being unpatentable over Terliuc in view of Fonger, Ohshiro, and Laduca as applied to claim 25 above, and further in view of Nakade et al. (U.S. PGPUB No. 2017/0095138), hereinafter Nakade.
Regarding claim 26, the modified system of Terliuc teaches the instrument port of claim 25, but Terliuc is silent to “wherein the pattern of slits comprises a plurality of fins that extend circumferentially on first and second sides of the metal tube, and wherein the fins on the first side and the fins on the second side are separated by first and second gaps, the first and second gaps extending along a plane defined by the shaft axis and an axis orthogonal to the shaft axis.”
However, Laduca teaches an instrument port (see Fig.1) with an elongated shaft (12), wherein the elongated shaft (12) comprises a metal tube (56, see 56 within shaft 12 in FIG. 5 and see [0069]: 56 can be laser cut hypotube and teaches a nitinol hypotube in [0070]), the metal tube (56) defined by a pattern of slits (see FIG. 7A and [0076]), wherein the pattern of slits comprises a plurality of fins (for example, fins 78 shown in FIG. 7B) that extend circumferentially on first (i.e.: a top side) and second (a bottom side) sides (see [0078]: cuts 78 in zone 74 can extend all the way around circumference or be ¼ or ½ helical wound around circumference) of the metal tube (56). Laduca also teaches that the slits can be provided in any pattern/variation/design to achieve a specific bending profile (see [0076-0078]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the elongated shaft disclosed in Terliuc to comprise a metal tube defined by a pattern of slits comprising a plurality of fins that extend circumferentially on first and second sides of the metal tube as taught by Laduca for the purpose of providing the shaft with a designed flexibility zone/direction based on the slit pattern (see [0076-0078]), thus achieving “wherein the pattern of slits comprises a plurality of fins that extend circumferentially on first and second sides of the metal tube,”.
Modified Terliuc in view of Laduca remain silent to “wherein the fins on the first side and the fins on the second side are separated by first and second gaps, the first and second gaps extending along a plane defined by the shaft axis and an axis orthogonal to the shaft axis”.
However, Nakade teaches an instrument port (see FIG. 1) with an elongated shaft (7, see FIG. 9 for all reference numerals following), wherein the shaft includes a pattern of slits (24au through 24dd), wherein the pattern of slits comprises a plurality of fins that extend circumferentially on first and second sides of the metal tube (see FIG. 9 and [0080-0081]: circumferentially disclosed slits across from each other, in alignment with fins as disclosed by applicant in FIG. 19 and [0117]), and wherein the fins on the first side and the fins on the second side are separated by first and second gaps (gaps A,C,C,D), the first and second gaps extending along a plane defined by the shaft axis and an axis orthogonal (such as an axis drawn vertically/ through the gaps) to the shaft axis (gaps extend along a plane defined by shaft axis and an axis orthogonal to the shaft axis in as much as is disclosed by Applicant in FIG.19 and [0048]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the fins on first and second sides of the elongated shaft taught by Modified Terliuc in view of Laduca to include first and second gaps extending along a plane defined by the shaft axis and an axis orthogonal to the shaft axis as taught by Nakade for the purpose of forming the shaft with a desired rigidity dependent on the gap size and placement (see [0087]), thus achieving “and wherein the fins on the first side and the fins on the second side are separated by first and second gaps, the first and second gaps extending along a plane defined by the shaft axis and an axis orthogonal to the shaft axis”.
Regarding claim 27, the modified system of Terliuc teaches the instrument port of claim 25, but Modified Terliuc is silent to “wherein the pattern of slits comprises an interrupted spiral.”
However, Nakade teaches an instrument port (see FIG. 1) with an elongated shaft (7, see FIG. 9 for all reference numerals following), wherein the shaft includes a pattern of slits (24au through 24dd), wherein the pattern of slits comprises a plurality of fins that extend circumferentially on first and second sides of the metal tube (see FIG. 9 and [0080-0081]: circumferentially disclosed slits across from each other, in alignment with fins as disclosed by applicant in FIG. 19 and [0117]), and wherein the fins on the first side and the fins on the second side are separated by first and second gaps (gaps A,C,C,D), the first and second gaps extending along a plane defined by the shaft axis and an axis orthogonal (such as an axis drawn vertically/ through the gaps) to the shaft axis (gaps extend along a plane defined by shaft axis and an axis orthogonal to the shaft axis in as much as is disclosed by Applicant in FIG.19 and [0048]), wherein the pattern of slits comprises an interrupted spiral (spiral interrupted by gap, aligning with applicant definition of interrupted spiral in as much as is disclosed in FIG. 19 and [0117]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the pattern of slits taught by Modified Terliuc in view of Laduca to comprise an interrupted spiral as taught by Nakade for the purpose of forming the shaft with a desired rigidity dependent on the gap size and placement (see [0087]), thus achieving “wherein the pattern of slits comprises an interrupted spiral.”
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Terliuc in view of Fonger and Ohshiro as applied to claim 14 above, and further in view of Nyuli et al. (U.S. PGPUB No. 2017/0165064), hereinafter Nyuli.
Regarding claim 28, the modified system of Terliuc teaches the instrument port of claim 14, but Terliuc is silent to “wherein the shaft comprises a flared shaft brake configured to engage the spindle while in the locked state, the flared shaft brake configured to disengage the spindle while in the unlocked state, wherein the locking housing further comprises an external surface traversing a length of the locking channel, wherein the external surface comprises an elevated external surface being higher on the locked side of the locking channel than on the unlocked side of the locking channel relative an axis of the shaft, and wherein sliding the shaft to the locked side causes the elevated external surface to create an upward force on the shaft so that the shaft enters the locked state.”
However, Nyuli teaches an instrument port (see FIG. 1) comprising a handle (4&5, see [0052]) with a locking housing (25), a mechanical lock (see FIG. 6 and [0062]: push button 613 activates mechanical lock) and a spindle (600/607, see [0062]), wherein the mechanical lock (see FIG. 6 and [0062]) includes a mechanical lock shaft (611), wherein the shaft (611) comprises a flared shaft brake (6041/608/609) configured to engage (by way of pegs 6041, see [0062]) the spindle (600/607) while in the locked state (see [0062]), the flared shaft brake (6041/608/609) configured to disengage (pegs 6041 released from spindle assembly when unlocked, see [0062]) the spindle (600/607) while in the unlocked state (see [0062]), wherein the locking housing (25) further comprises an external surface (613) traversing a length (thickness of 613)) of a locking channel (channel through assembly/ along shaft 611 shown in FIG. 6 and Figs. 9A-C), wherein the external surface (613) comprises an elevated external surface (elevated position of flat face of 613 when 613 has moved to locked position such as through arrow 720, see ‘Modified FIG. 9C’ below)
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being higher on a locked side (when button is NOT depressed) of the locking channel than on an unlocked side (when button is depressed such as shown in FIG. 9B) of the locking channel relative an axis of the shaft (see FIG. 9A with 613 in “elevated”/ higher position before being pressed down to enter an unlocked state as described in [0062] and [0067]), and wherein sliding (see [0062] shaft 611 slides with button) the shaft (611) to the locked side (see arrow 720 in FIG. 9C, [0062] and [0067]) causes the elevated external surface (position of button moving to position along arrow 720) to create an upward force on the shaft (611) so that the shaft (611) enters the locked state (see [0067-0069], specifically [0069 and FIG. 9C. The locked state creates force in direction of arrows 750==upward to enter the locked state).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date, to have substituted the mechanical lock comprising a shaft having a shaft axis extending through the spindle taught in Modified Terliuc with the mechanical lock comprising a shaft, wherein the shaft comprises a flared shaft brake configured to engage the spindle while in the locked state, the flared shaft brake configured to disengage the spindle while in the unlocked state, wherein the locking housing further comprises an external surface traversing a length of the locking channel, wherein the external surface comprises an elevated external surface being higher on the locked side of the locking channel than on the unlocked side of the locking channel relative an axis of the shaft, and wherein sliding the shaft to the locked side causes the elevated external surface to create an upward force on the shaft so that the shaft enters the locked state as taught in Nyuli.
A person of ordinary skill in the art would have been motivated to make this modification because it is a simple substitution of one known element (a handle with a mechanical lock having a shaft extending through a spindle taught by Modified Terliuc) for another known element (a handle with a mechanical lock having a shaft comprising a flared shaft brake configured to engage the spindle while in the locked state, the flared shaft brake configured to disengage the spindle while in the unlocked state, wherein the locking housing further comprises an external surface traversing a length of the locking channel, wherein the external surface comprises an elevated external surface being higher on the locked side of the locking channel than on the unlocked side of the locking channel relative an axis of the shaft, and wherein sliding the shaft to the locked side causes the elevated external surface to create an upward force on the shaft so that the shaft enters the locked state taught in Nyuli) in the art to obtain the predictable result of locking a rotatable spindle element of an articulable catheter device by way of a mechanical lock shaft (see MPEP § 2143.I.B), thus achieving “wherein the shaft comprises a flared shaft brake configured to engage the spindle while in the locked state, the flared shaft brake configured to disengage the spindle while in the unlocked state, wherein the locking housing further comprises an external surface traversing a length of the locking channel, wherein the external surface comprises an elevated external surface being higher on the locked side of the locking channel than on the unlocked side of the locking channel relative an axis of the shaft, and wherein sliding the shaft to the locked side causes the elevated external surface to create an upward force on the shaft so that the shaft enters the locked state.”
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 and 14 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
In view of the heavily amended subject matter, the current examiner has applied new 35 U.S.C. § 103 rejections of all claims with all new references compared to that as applied by the previous examiner in the Non-final rejection mailed 04/28/25, rendering the arguments filed 07/28/25 against the previous references moot.
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 KATHLEEN PAIGE VOKES whose telephone number is (571)272-0198. The examiner can normally be reached M-F: 730AM-330PM Eastern Time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHLEEN PAIGE VOKES/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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