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 .
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on 06/13/25 and 07/25/25 were filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Response to Amendment
The amendment filed 08/19/25 has been entered. Claims 1 and 25 have been amended. Claims 2-6, 10-11, 26-29, and 31 are in the original/ previously presented form. Claims 7-9, 12-24, and 30 have been withdrawn. Thus, claims 1-6, 10-11, 25-29, and 31 remain pending in the application. Applicant’s amendments to the Claims have overcome each and every 112(b) rejection previously set forth in the Non-Final Office Action mailed 05/19/25, hereinafter NFOA.
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 25-29 and 31 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 25, lines 38- 40 recite “a handle attached to the proximal end of the elongated shaft, the handle including a spindle in mechanical communication with the bendable shaft to adjust a customizable angle of the steerable tip, the customizable angle measured between the shaft axis and the tip axis;”. However, the claim language reciting “adjust a customizable angle of the steerable tip, the customizable angle measured between the shaft axis and the tip axis;” is unclear because a customizable angle of the steerable tip, specifically measured between the shaft and tip axis has already been set forth in lines 9-10 of claim 25. Thus, it is unclear if the amended “a customizable angle of the steerable tip” in lines 38-40 is a different customizable angle to that as previously recited in claim 25. According to Applicant disclosure (see at least [0140]), the handle is used to control the steerable tip and therefore it seems likely that the customizable angle of the steerable tip and the customizable angle controlled by the handle refer to the same customizable angle.
Therefore, for purposes of examination, the examiner interprets claim 25 lines to read “a handle attached to the proximal end of the elongated shaft, the handle including a spindle in mechanical communication with the bendable shaft to adjust [[a]] the customizable angle of the steerable tip[[, the customizable angle measured between the shaft axis and the tip axis]];”.
Due to claim dependency, claims 26-29 and 31 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 1-3, 10, 25, and 29 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 Cardinale et al. (U.S. Patent No. 10,610,345), hereinafter Cardinale, 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 for epicardial ablation 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 unbent state such as seen in FIG. 2A. 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 elongated shaft (334) having a fluid port (302) defined in an external surface (see zoomed in cross-section in FIG. 3A) at the distal end (shaft portion between 310 and 370) of the elongated shaft (334);
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) comprising a customizable angle (see [0118]: bendable shaft 314 is selectively bendable and therefore has a “customizable” bending amount or angle), the customizable angle measured between the shaft axis and a tip axis (see ‘Modified FIG. 3A’ below),
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and when the bendable shaft (314) is in an unbent state (see FIG. 2A just for exemplary reference as explained above in reference to other embodiment of bendable shaft 314 in [0102]):
the bendable shaft (314) extends along 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);
an offset balloon (354) attached to the external surface (see [0121]: balloon 354 sealingly mounted over shaft 334) of the elongated shaft (334), circumferentially encapsulating (see [0121]: balloon 354 sealing mounted over shaft and thus must circumferentially encapsulate the shaft to be “sealed”) a portion of the elongated shaft (334) along a length (see ‘Modified FIG. 3Ai’ below) of the elongated shaft (334),
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and having a continuous outer circumference (see [0121]: ballon mounted in sealing relationship with shaft and thus must have a continuous outer circumference to enable the “sealing”), the offset balloon (354) having an internal volume in fluid communication (see [0123-0124]: balloon has inflatable/deflatable “interior”==internal volume) with the fluid port (302), the offset balloon (354) having 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 shaft axis lying in an inflation plane (see ‘Modified FIG. 3A’ above), 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), 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), and
a working tube (322) disposed in (see 322 in Section A-A view shown within shaft 334 of FIG. 3A) the elongated shaft (334) and extending from its proximal end to its distal end (see [0116]: channel 322 extends through entire length of endoscope 300, which includes the shaft), 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).
Terliuc is silent to “wherein the customizable angle is within a range of 0° to 90°”,
the bendable shaft being formed such that:
“a plurality of mechanical rings concentrically disposed along the distal end of the shaft;
a plurality of mechanical links mechanically coupled to the plurality of mechanical rings,
the plurality of mechanical links configured to restrict a flexibility of a bendable shaft within a rigidity plane, and
the plurality of mechanical links configured to enable the flexibility of the bendable shaft about a pivot axis;
wherein the plurality of mechanical links enables the bendable shaft to bend in a direction corresponding to the inflation plane;” and
the offset balloon being “radially asymmetrically” inflated with respect to the shaft axis, the offset balloon height “that is greater than” the bend distance “when the customizable angle is 90°”
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 the shaft (602), a plurality of mechanical rings (642A-F) concentrically disposed (see FIG. 17A) along the distal end (rightward in FIG. 17A) of the shaft (602); a plurality of mechanical links (676, see FIG. 15B) mechanically coupled to (see col. 15 lines 35-54: 676 hingedly connects each ring 642 to one another and see col. 16 lines 12-20) the plurality of mechanical rings (642A-F), the plurality of mechanical links (676) configured to restrict a flexibility of a bendable shaft (portion of shaft 602 comprising rings that bends as seen in FIG. 17A) within a rigidity plane (see 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 as seen in “pivot axis” 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 rigidity plane under regular use, even if left/right bending along rigidity plane is permitted by device.),
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and the plurality of mechanical links (672) configured to enable the flexibility of the bendable shaft (portion of shaft 602 comprising rings that bends as seen in FIG. 17A) about a pivot axis (see col. 15 line 55- col. 16 line 20: articulation described such that hinge is only on “bottom” side of each ring. Thus, articulation is only enabled about the hinge/ pivot axis, see ‘Modified FIG. 17A’ above); wherein the plurality of mechanical links (672) enables the bendable shaft (portion of shaft 602 comprising rings that bends as seen in FIG. 17A) to bend in a direction (“upward” as shown in FIG. 17A) corresponding to a longitudinally aligned plane (see ‘Modified FIG. 17A’ 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 substitute the bendable shaft articulation mechanism disclosed in Terliuc with the articulation mechanism comprising a plurality of mechanical links and rings 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 bendable shaft being formed such that: “a plurality of mechanical rings concentrically disposed along the distal end of the shaft; a plurality of mechanical links mechanically coupled to the plurality of mechanical rings, the plurality of mechanical links configured to restrict a flexibility of a bendable shaft within a rigidity plane, and the plurality of mechanical links configured to enable the flexibility of the bendable shaft about a pivot axis; wherein the plurality of mechanical links enables the bendable shaft to bend in a direction corresponding to the inflation plane.”
Terliuc in view of Cardinale remain silent to “wherein the customizable angle is within a range of 0° to 90°” and the offset balloon being “radially asymmetrically” inflated with respect to the shaft axis, the offset 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 bendable 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) and a tip axis (horizontal line shown in FIG>. 18 that extends through tip 50), 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 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 bendable shaft taught by Terliuc in view of Cardinale 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 Cardinale and Fonger remain silent to the offset balloon being “radially asymmetrically” inflated with respect to the shaft axis, the offset 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 therefore 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 the offset balloon being “radially asymmetrically” inflated with respect to the shaft axis.
Next, 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 Cardinale and 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 offset balloon height “that is greater than” the bend distance “when the customizable angle is 90°”
Regarding claim 2, the modified system of Terliuc teaches the instrument port of claim 1, and Terliuc discloses further comprising a fluid tube (see [0113]: shaft can be provided with fluid conduit for inflating the balloon) disposed in the elongated shaft (see [0112]: shaft includes port 302 communicating internally of shaft), the fluid tube (see [0113]: a fluid conduit) fluidly coupled to the fluid port (302, see [0113]: fluid conduit provides inflation/ deflation of balloon through port 302 and therefore MUST be fluidly coupled to the port to enable inflation/deflation).
Regarding claim 3, the modified system of Terliuc teaches the instrument port of claim 1, and Terliuc further discloses wherein: a proximal side (see ‘Modified FIG. 3Aiii’ below) of the offset balloon (354)
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is attached to the external surface (see [0121]: balloon 354 sealingly mounted over shaft 334, such as by ultrasonic welding, and overlies port 302) of the elongated shaft (334) on a proximal side (toward handle as shown in FIG. 3A) of the fluid port (302), and a distal side (see ‘Modified FIG. 3Aiii’ above) of the offset balloon (354) is attached to the external surface (see [0121]: balloon 354 sealingly mounted over shaft 334, such as by ultrasonic welding, and overlies port 302) of the elongated shaft (334) on a distal side (toward distal tip as shown in FIG.3A) of the fluid port (302).
Regarding claim 10, the modified system of Terliuc teaches the instrument port of claim 1, and Terliuc further discloses wherein the offset balloon (354, see FIG. 3A) is inflated with respect to an inflation plane, the shaft axis lying in the inflation plane (see ‘Modified FIG. 3A’ provided again below for reference).
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Terliuc is silent to the offset balloon “radially asymmetrically” inflated
However, Ohshiro 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), wherein the offset balloon (44) is radially asymmetrically inflated (balloon 44 inflated on one side of shaft axis, and thus is inflated radially asymmetrically) with respect to an inflation plane, the shaft axis lying in the inflation plane (see ‘Modified FIG. 4i’ below).
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Therefore, again, 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 the offset balloon “radially asymmetrically” inflated.
Regarding claim 25, 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 unbent state such as seen in FIG. 2A. 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 elongated shaft (334) having a fluid port (302) defined in an external surface (see zoomed in cross-section in FIG. 3A) at the distal end (shaft portion between 310 and 370) of the elongated shaft (334);
a bendable shaft (314, see [0102]: selectably bendable) attached to the distal end (shaft portion between 310 and 370) of the elongated shaft (334);
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 (leftward end of shaft 314 in Fig. 3A) of the bendable shaft (314), the steerable tip (370) extending along a tip axis (see ‘Modified FIG. 3A’ below),
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the steerable tip (370) comprising a customizable angle (see [0118]: bendable shaft 314 is selectively bendable and therefore has a “customizable” bending amount or angle), the customizable angle measured between the shaft axis and the tip axis (see ‘Modified FIG. 3A’ above), and when the bendable shaft (314) is in an unbent state (see FIG. 2A just for exemplary reference as explained above in reference to other embodiment of bendable shaft 314 in [0102]):
the bendable shaft (314) extends along 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);
an offset balloon (354) attached to the external surface (see [0121]: balloon 354 sealingly mounted over shaft 334) of the elongated shaft (334) and circumferentially encapsulating (see [0121]: balloon 354 sealing mounted over shaft and thus must circumferentially encapsulate the shaft to be “sealed”) a portion of the elongated shaft (334), the offset balloon (354) having an internal volume in fluid communication (see [0123-0124]: balloon has inflatable/deflatable “interior”==internal volume) with the fluid port (302), the offset balloon (354) having 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 bending (see [0118]: bending section 314 is “selectably” bendable via steering mechanism or knobs 324,326 in handle) of the bendable shaft (314) is independent of the inflated state and the deflated state of the offset balloon (354, see [0125]: inflation/deflation of balloon controlled with control system independent from steering mechanism of bendable shaft);
wherein in the inflated state (as shown in FIG. 3A) the offset balloon (354) is inflated with respect to the shaft axis lying in an inflation plane (see ‘Modified FIG. 3A’ above); 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);
a fluid tube (see [0113]: shaft can be provided with fluid conduit for inflating the balloon) disposed in the elongated shaft (see [0112]: shaft includes port 302 communicating internally of shaft), the fluid tube (see [0113]: a fluid conduit) fluidly coupled to the fluid port (302, see [0113]: fluid conduit provides inflation/ deflation of balloon through port 302 and therefore MUST be fluidly coupled to the port to enable inflation/deflation);
a working tube (322) disposed in (see 322 in Section A-A view shown within shaft 334) the elongated shaft (334), 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
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 bendable shaft (314) to adjust [[a]] the customizable angle (see ‘Modified FIG. 3A’ above) of the steerable tip (see [0118]: operator manipulates steering knobs 324/326 to selectably bend the bending section 314 of the shaft. Therefore the knobs MUST be somehow mechanically communicating with the bendable shaft such as by features not shown as noted in [0116]), [[the customizable angle measured between the shaft axis and the tip axis;]]
Terliuc is silent to:
“a plurality of mechanical rings concentrically disposed along the bendable shaft;”
“a plurality of mechanical links mechanically coupled to the plurality of mechanical rings;”
“wherein the customizable angle is within a range of 0° to 90°,”
“the plurality of mechanical links configured to restrict a flexibility of the bendable shaft within a rigidity plane, and
the plurality of mechanical links configured to enable the flexibility of the bendable shaft about a pivot axis;
the flexibility of the bendable shaft about the pivot axis configured to enable movement of the steerable tip in at least one of a first direction and a second direction;”
the offset balloon being inflated “radially asymmetrically”
“wherein the plurality of mechanical links enables the bendable shaft to bend in a direction corresponding to the inflation plane,”
the offset balloon height “that is greater than” the bend distance “when the customizable angle is 90°”
and the handle including a “spindle” in mechanical communication with the bendable shaft, and
“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.”
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 bendable shaft portion (portion of shaft 602 comprising rings that bends as seen in FIG. 17A) of the elongated shaft (602), a plurality of mechanical rings (642A-F) concentrically disposed (see FIG. 17A) along the bendable shaft (portion of shaft 602 comprising rings that bends as seen in FIG. 17A), a plurality of mechanical links (676, see FIG. 15B) mechanically coupled to (see col. 15 lines 35-54: 676 hingedly connects each ring 642 to one another and see col. 16 lines 12-20) the plurality of mechanical rings (642A-F), the plurality of mechanical links (676) configured to restrict a flexibility of the bendable shaft (portion of shaft 602 comprising rings that bends as seen in FIG. 17A) within a rigidity plane (see 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 as seen in “pivot axis” 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 rigidity plane under regular use, even if left/right bending along rigidity plane is permitted by device.),
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and the plurality of mechanical links (672) configured to enable the flexibility of the bendable shaft (portion of shaft 602 comprising rings that bends as seen in FIG. 17A) about a pivot axis (see col. 15 line 55- col. 16 line 20: articulation described such that hinge is only on “bottom” side of each ring. Thus, articulation is only enabled about the hinge/ pivot axis, see ‘Modified FIG. 17A’ above); the flexibility of the bendable shaft (portion of shaft 602 comprising rings that bends as seen in FIG. 17A) about the pivot axis (see “Modified FIG. 17A’ above) configured to enable movement (see col 15 line 55-col. 16 line 3: bending/articulation is actuated & see col. 15 line 9-14: shaft has straight and articulated configuration. Therefore movement is enabled) of the steerable tip (642G) in at least one of a first direction and a second direction (movement of steerable tip in “upward”==a first direction as shown in FIG. 17A), wherein the plurality of mechanical links (672) enables the bendable shaft (portion of shaft 602 comprising rings that bends as seen in FIG. 17A) to bend in a direction (“upward” as shown in FIG. 17A) corresponding to a longitudinally aligned plane (see ‘Modified FIG. 17A’ 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 substitute the bendable shaft articulation mechanism disclosed in Terliuc with the articulation mechanism comprising a plurality of mechanical links and rings 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 “a plurality of mechanical rings concentrically disposed along a bendable shaft, a plurality of mechanical links mechanically coupled to the plurality of mechanical rings, the plurality of mechanical links configured to restrict a flexibility of the bendable shaft within a rigidity plane, and the plurality of mechanical links configured to enable the flexibility of the bendable shaft about a pivot axis; the flexibility of the bendable shaft about the pivot axis configured to enable movement of the steerable tip in at least one of a first direction and a second direction, wherein the plurality of mechanical links enables the bendable shaft to bend in a direction corresponding to the inflation plane.”
Terliuc in view of Cardinale remain silent to “wherein the customizable angle is within a range of 0° to 90°”, the offset balloon being “radially asymmetrically” inflated with respect to the shaft axis, the offset balloon height “that is greater than” the bend distance “when the customizable angle is 90°”, and the handle including
a “spindle” in mechanical communication with the bendable shaft, and
“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.”
However, Fonger teaches an instrument port (see FIG. 18) with a bendable 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). Fonger further teaches the instrument port (see ‘Modified FIG. 18’ above) comprising
a handle (30, see [0069]) including a spindle (a central shaft for rotating a component) in mechanical communication with the bendable shaft (see [0072]: levers 51/52 articulate bendable 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), and
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 bendable shaft taught by Terliuc in view of Cardinale 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°”.
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 bendable 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 handle including
a “spindle” in mechanical communication with the bendable shaft, and
“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 Cardinale and Fonger remain silent to the offset balloon being “radially asymmetrically” inflated with respect to the shaft axis and the offset 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 the offset balloon being “radially asymmetrically” inflated with respect to the shaft axis.
Next, 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 Cardinale and 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 offset balloon height “that is greater than” the bend distance “when the customizable angle is 90°”
Regarding claim 29, the modified system of Terliuc teaches the instrument port of claim 25, and Terliuc further discloses wherein: a proximal side (see ‘Modified FIG. 3Aiii’ below) of the offset balloon (354)
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is attached to the external surface (see [0121]: balloon 354 sealingly mounted over shaft 334, such as by ultrasonic welding, and overlies port 302) of the elongated shaft (334) on a proximal side (toward handle as shown in FIG. 3A) of the fluid port (302), and a distal side (see ‘Modified FIG. 3Aiii’ above) of the offset balloon (354) is attached to the external surface (see [0121]: balloon 354 sealingly mounted over shaft 334, such as by ultrasonic welding, and overlies port 302) of the elongated shaft (334) on a distal side (toward distal tip as shown in FIG.3A) of the fluid port (302).
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Terliuc in view of Cardinale, Fonger, and Ohshiro as applied to claim 3 above, and further in view of Valley et al. (U.S. PGPUB No. 2001/0016725), hereinafter Valley.
Regarding claim 4, the modified system of Terliuc teaches the instrument port of claim 3, but Modified Terliuc is silent to “wherein the offset balloon is formed of a wall having a variable wall thickness.”
However, Valley teaches an instrument port with an offset balloon (710’, see FIG. 14), wherein the offset balloon (710’) is formed of a wall with variable wall thickness (712 and 714, see [0167]: ‘thicker’ wall 712 and ‘thinner’ wall 714).
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 offset balloon taught by Modified Terliuc to be formed of a wall having a variable wall thickness as taught by Valley for the purpose of forming a thinner wall that more easily expands to form an asymmetrical balloon profile (see [0167]), thus achieving “wherein the offset balloon is formed of a wall having a variable wall thickness.”
Regarding claim 5, the modified system of Terliuc teaches the instrument port of claim 4, but Terliuc is silent to “wherein: a first portion of the wall has a relatively thin wall thickness compared to a second portion of the wall that has a relatively thick wall thickness, and the first portion of the wall is on a first side of the elongated shaft, whereby in the inflated state the offset balloon is radially asymmetrically inflated.”
However, Ohshiro 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), whereby in the inflated state (as shown in FIG. 4) the offset balloon (44) is radially asymmetrically inflated (balloon 44 inflated on one side of shaft axis, and thus is inflated radially asymmetrically).
Therefore, again, 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 “whereby in the inflated state the offset balloon is radially asymmetrically inflated.”
Modified Terliuc remains silent to “wherein: a first portion of the wall has a relatively thin wall thickness compared to a second portion of the wall that has a relatively thick wall thickness, and the first portion of the wall is on a first side of the elongated shaft”
However, Valley teaches a radially asymmetrically inflated offset balloon (710’, see FIG. 14) wherein: a first portion (714) of the wall has a relatively thin wall thickness compared to a second portion (712) of the wall that has a relatively thick wall thickness (see [0167]: ‘thicker’ wall 712 and ‘thinner’ wall 714). Valley also teaches the first portion (714) of the wall is on a first side (in leftward direction, see longest arrow, in FIG.14) of an elongated shaft (702), whereby in the inflated state the offset balloon is radially asymmetrically inflated (see asymmetric inflation in FIG. 14 and described in [0167]).
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 offset balloon taught by Modified Terliuc to be formed of a wall having a variable wall thickness such that a thinner wall thickness is on a first side of the elongated shaft as taught by Valley for the purpose of forming a thinner wall that more easily expands to form the asymmetrical balloon profile (see [0167]), thus achieving “wherein: a first portion of the wall has a relatively thin wall thickness compared to a second portion of the wall that has a relatively thick wall thickness, and the first portion of the wall is on a first side of the elongated shaft.”
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Terliuc in view of Cardinale, Fonger, Ohshiro, and Valley as applied to claim 5 above, and further in view of Khanicheh et al. (U.S. PGPUB No. 2019/0022359), hereinafter Khanicheh.
Regarding claim 6, the modified system of Terliuc teaches the instrument port of claim 5, and Terliuc further discloses wherein the proximal and distal sides (see ‘Modified FIG. 3Aiii’ under the rejection of claim 3 above) of the offset balloon (354, see FIG. 3A) are attached to the external surface (see [0121]: balloon 354 sealingly mounted over shaft 334, such as by ultrasonic welding), but Modified Terliuc is silent to the attachment being “by tie-downs, bonds, and/or heat seals.”
However, Khanicheh teaches an instrument port with an offset balloon (120, see FIG. 2C), wherein the proximal and distal sides of the offset balloon are attached to the external surface by tie-downs, bonds, and/or heat seals (see [0051]: balloon may be bonded by, i.e., heat seals, [0061]: balloon attached on proximal and distal sides of shaft of portion 220).
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 offset balloon affixed to the external shaft on proximal and distal ends disclosed in Terliuc to be attached specifically by heat seals as taught by Khanicheh for the purpose of bonding the balloon to the shaft utilizing methods known in the art (see [0051]), thus achieving the attachment being “by tie-downs, bonds, and/or heat seals.”
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Terliuc in view of Cardinale, Fonger, and Ohshiro as applied to claim 1, above, and further in view of Khanicheh (U.S. PGPUB No. 2019/0022359).
Regarding claim 11, the modified system of Terliuc teaches the instrument port of claim 1, and Terliuc further discloses wherein the offset balloon ( 354, see FIG. 3A) is controllably inflated and deflated (see [0113] & [0123]: balloon inflated/ deflated via port 302 and [0125]: inflation/deflation control system), but Terliuc is silent to specific inflation states such as “wherein the offset balloon has a partially-inflated state in which a partially-inflated volume of the offset balloon is in a range of about 10% to about 90% of a fully-inflated volume of the offset balloon, the offset balloon having the fully-inflated volume when the offset balloon is in a fully-inflated state.”
However, Khanicheh teaches an instrument port with an offset balloon (120, see FIG. 2C), wherein the offset balloon (120) has a partially-inflated state (see [0047]: balloon inflated and deflated between a deflated state and one or more inflated states and [0050]: balloon may be inflated to full capacity or may be partially inflated) in which a partially-inflated volume (see [0050]: partial inflation state described) of the offset balloon (120) is in a range of about 10% to about 90% (there MUST exist a point in time during the controllable inflation of the balloon wherein the inflation is terminated and the balloon volume is partially-inflated to a range of about 10% (more than 0%/ a deflated state) to 90% (less than 100%/ a fully inflated state)) of a fully-inflated (100% inflated as shown in FIG. 2C) volume of the offset balloon (120), the offset balloon (120) having the fully-inflated volume (100%) when the offset balloon is in a fully-inflated state (see FIG. 2C).
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 controllably inflatable offset balloon disclosed in Terliuc with the one or more partially inflated states as taught by Khanicheh for the purpose of controlling the inflated balloon size for use in different tubular body structures (see [0050-0051]), thus achieving “wherein the offset balloon has a partially-inflated state in which a partially-inflated volume of the offset balloon is in a range of about 10% to about 90% of a fully-inflated volume of the offset balloon, the offset balloon having the fully-inflated volume when the offset balloon is in a fully-inflated state.”
Claims 26-28 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Terliuc in view of Cardinale, Fonger, and Ohshiro as applied to claim 25 above, and further in view of Khanicheh (U.S. PGPUB No. 2019/0022359).
Regarding claim 26, the modified system of Terliuc teaches the instrument port of claim 25, and Terliuc discloses further comprising a handle (310, see FIG. 3A) attached to the proximal end (rightward most end of 334) of the elongated shaft (334), the handle (310) is fluidly coupled to the fluid tube (see [0113]: through a fluid conduit) to introduce or receive a fluid (see [0113]: fluid provided through conduit to form a dedicated inflation/ deflation channel for the balloon and thus must introduce an inflation fluid).
Modified Terliuc is silent to the handle “including a handle fluid port that” is fluidly coupled to the fluid tube
However, Khanicheh teaches an instrument port (see FIG. 1B) comprising a handle (130) attached to the proximal end (rightward of 114) of an elongated shaft (110), the handle (130) including a handle fluid port (132) that is fluidly coupled to a fluid tube (see [0055]: 132 fluidly coupled to lumen through tube 214) to introduce or receive a fluid (see [0049]: 132 provided to supply fluid, air, for inflation/ deflation of balloon).
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 handle that is fluidly coupled to a fluid tube taught by Modified Terliuc to include a handle fluid port as taught by Khanicheh for the purpose of providing a port to connect an air supply device for the controllable inflation/deflation of the balloon (see [0049] & [0055]), thus achieving the handle “including a handle fluid port that” is fluidly coupled to the fluid tube
Regarding claim 27, the modified system of Terliuc teaches the instrument port of claim 26, and Terliuc further discloses wherein a distal end of the fluid tube ([0113]: a fluid conduit) is capped to define a closed fluid path (see [0112-0113]: fluid port 302 communicates with interior or fluid conduit in a sealed manner== is capped to define a closed fluid path that is conventional in the art) between the handle (310) and the fluid port (302).
Modified Terliuc is silent to the handle “fluid port”
However, Khanicheh teaches an instrument port (see FIG. 1B) comprising a handle (130) attached to the proximal end (rightward of 114) of an elongated shaft (110), the handle (130) including a handle fluid port (132) that is fluidly coupled to a fluid tube (see [0055]: 132 fluidly coupled to lumen through tube 214) to introduce or receive a fluid (see [0049]: 132 provided to supply fluid, air, for inflation/ deflation of balloon).
Therefore, again, 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 handle that is fluidly coupled to a fluid tube taught by Modified Terliuc to include a handle fluid port as taught by Khanicheh for the purpose of providing a port to connect an air supply device for the controllable inflation/deflation of the balloon (see [0049] & [0055]), thus achieving the handle “fluid port”
Regarding claim 28, the modified system of Terliuc teaches the instrument port of claim 27, and Terliuc further discloses wherein: the fluid tube (see [0113]: a fluid conduit) includes a fluid tube aperture (see [0113]: fluid conduit enables inflation/ deflation channel for balloon and therefore MUST have a fluid tube aperture to allow the inflation fluid to escape the conduit and enter the balloon for enabling inflation), and the fluid tube (see [0113]: a conduit) is attached to the elongated shaft (see [0113-0114]: conduit provided within interior volume 306 of endoscope and thus is attached to the shaft) to fluidly couple the fluid tube aperture (see [0113]: fluid conduit enables inflation of balloon and therefore the fluid tube aperture of the conduit MUST be fluidly coupled to the fluid port to allow the inflation fluid to escape the conduit and enter the balloon through the port 302 for enabling inflation) and the fluid port (302).
Modified Terliuc is silent to the fluid tube is attached to “an internal surface at the distal end of” the elongated shaft
However, Khanicheh teaches an instrument port (see FIG. 1B), wherein: a fluid tube (see [0055]: 132 fluidly coupled to lumen through tube 214) includes a fluid tube aperture (see [0058]: opening, not shown, extending through wall of catheter), and the fluid tube (see [0055]: 132 fluidly coupled to lumen through tube 214) is attached to an internal surface (inside surface of 220, see FIG. 2B and [0058]) at the distal end (distal end as shown in FIG. 2B) of the elongated shaft (110) to fluidly couple (see [0058]: air supplied through lumen flows through fluid tube aperture, through fluid port 214, and into balloon, not shown in FIG.2B, for inflation) the fluid tube aperture (see opening, not shown, extending through wall of catheter in [0058] and FIG. 2B), and the fluid port (214, see [0055]).
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 fluid tube attached to the elongated shaft taught by Modified Terliuc to be attached to an internal surface at the distal end of the elongated shaft as taught by Khanicheh for the purpose of providing the fluid tube along the length of the device to convey fluid from the inflation fluid source to the fluid port for inflation of the balloon (See [0058]), thus achieving the fluid tube is attached to “an internal surface at the distal end of” the elongated shaft
Regarding claim 31, the modified system of Terliuc teaches the instrument port of claim 25, and Terliuc further discloses wherein the offset balloon ( 354, see FIG. 3A) is controllably inflated and deflated (see [0113] & [0123]: balloon inflated/ deflated via port 302 and [0125]: inflation/deflation control system), but Terliuc is silent to specific inflation states such as “wherein the offset balloon has a partially-inflated state in which a partially-inflated volume of the offset balloon is in a range of about 10% to about 90% of a fully-inflated volume of the offset balloon, the offset balloon having the fully-inflated volume when the offset balloon is in the inflated state.”
However, Khanicheh teaches an instrument port with an offset balloon (120, see FIG. 2C), wherein the offset balloon (120) has a partially-inflated state (see [0047]: balloon inflated and deflated between a deflated state and one or more inflated states and [0050]: balloon may be inflated to full capacity or may be partially inflated) in which a partially-inflated volume (see [0050]: partial inflation state described) of the offset balloon (120) is in a range of about 10% to about 90% (there MUST exist a point in time during the controllable inflation of the balloon wherein the inflation is terminated and the balloon volume is partially-inflated to a range of about 10% (more than 0%/ a deflated state) to 90% (less than 100%/ a fully inflated state)) of a fully-inflated (100% inflated as shown in FIG. 2C) volume of the offset balloon (120), the offset balloon (120) having the fully-inflated volume (100%) when the offset balloon is in the inflated state (see FIG. 2C).
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 controllably inflatable offset balloon disclosed in Terliuc with the one or more partially inflated states as taught by Khanicheh for the purpose of controlling the inflated balloon size for use in different tubular body structures (see [0050-0051]), thus achieving “wherein the offset balloon has a partially-inflated state in which a partially-inflated volume of the offset balloon is in a range of about 10% to about 90% of a fully-inflated volume of the offset balloon, the offset balloon having the fully-inflated volume when the offset balloon is in the inflated state.”
Response to Arguments
Applicant's arguments filed 08/19/25 have been fully considered but they are not persuasive.
On page 11, Applicant asserts that the combination of references fail to teach “wherein, in the inflated state, the offset balloon has a height, measured with respect to a vertical axis that is orthogonal to the shaft axis, that is greater than a bend distance, measured from the distal end of the steerable tip to an external surface on the distal end of the elongated shaft, when the customizable angle is 90°”. However, the examiner disagrees with the characterization of the rejection as presented by Applicant and maintains the 35 U.S.C § 103 rejections under Terliuc in view of Cardinal, Fonger, and Ohshiro.
To support the assertion of page 11, Applicant references Terliuc’ s Modified FIG. 3Aii (this modified figure was previously provided by the examiner in the NFOA) on page 12 of Applicant remarks. Applicant argues that because Terliuc’ s Modified FIG. 3Aii does not show the offset balloon having a height “greater than a bend distance when the customizable angle is 90degrees”, the claim limitation has not been met.
However, the examiner disagrees and was not persuaded by this argument because the claim rejection relies on a combination of references (35 U.S.C. § 103) and does not rely solely on Terliuc (35 U.S.C. § 102). Although Terliuc is silent to the argued claim limitation (as noted by the examiner on page 9 of the NFOA), the combination of references sufficiently teaches all limitations (see pages 12-14 of the NFOA for the combination in view of Ohshiro that is used to teach the argued claim limitation involving the offset balloon height being greater than a bend distance and/or see the rejection of claims 1 & 25 above). Therefore, in response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Thus, the examiner maintains that the combination of references meet all claim limitations and therefore the examiner maintained the 35 U.S.C. § 103 claim rejections of independent claims 1 and 25 under Terliuc in view of Cardinal, Fonger, and Ohshiro.
Next, on page 15 of Applicant remarks, Applicant argues that none of the references teach the amended limitation of claim 25 including the handle/ mechanical lock recitations. However, Applicant's arguments do not comply with 37 CFR 1.111(c) because they do not clearly point out the patentable novelty which he or she thinks the claims present in view of the state of the art disclosed by the references cited or the objections made. Further, they do not show how the amendments avoid such references or objections. Applicant does not present how the prior art references, such as Fonger (used to teach the amended limitation of claim 25, see the rejection above), fail to teach the limitation as argued.
Therefore, the examiner was not persuaded by the argument and maintained the 35 U.S.C. § 103 claim rejection of claim 25 under Terliuc in view of Cardinal, Fonger, and Ohshiro.
Because no further arguments were presented, all depending claim rejections were subsequently maintained by the examiner.
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 FARRELL whose telephone number is (571)272-0198. The examiner can normally be reached M-F: 730AM-330PM Eastern Time.
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 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 FARRELL/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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