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
Amendments to claims 12, 16 of 7/23/2026 acknowledged and entered.
New claim 21 of 7/23/2026 acknowledged and entered.
Cancellation of claim 13 of 7/23/2026 acknowledged and entered.
Response to Arguments
Applicant's arguments filed 7/23/2026 have been fully considered but they are not persuasive.
Regarding p. 10, para. 2, examiner is not in accordance with applicant’s assessment. By broadest reasonable interpretation, the claims, as they stand, do not provide a structural incompatibility between the “inflatable channel” of the instant application and a standard pressure balloon such as the one taught in Zhao. A pressure balloon constitutes a closed-end lumen at the distal end of a fluid channel of an endoscope. The standing claims do not preclude an endoscope with “inflatable channels” with differently shaped closed distal ends. Examiner interprets the pressure balloons and fluid lines feeding said balloons to be of a single assembly, hence forming an inflatable channel featuring a distal end that is closed by the balloon structure.
Examiner maintains standing rejection of 4/23/2026.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 11-15, 18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhao (WO 2020046979 A1).
Regarding claim 11, Zhao teaches A medical device comprising:
a handle (fig. 14, element 52, [0123] control unit or system 52 disposed at the proximal end of the tube); and
a shaft (fig. 2a, element 1, [0104], distal portion of deice 1) extending from the handle, the shaft including a plurality of lumens or channels (fig. 17a, element 30a-c, [0128], pressure balloons 30a-c) extending longitudinally through the shaft to a distal end of the shaft, wherein the plurality of lumens or channels comprises:
a central lumen ([0128], pressure balloons have lumen) extending to a distal opening at the distal end of the shaft, and
a plurality of inflatable channels ([0128], inflation of balloons controls expansion), each extending to a closed distal end at the distal end of the shaft;
wherein the plurality of inflatable channels have an inflated state and a deflated state ([0128], expandable structures configured to expand or contract),
wherein, in the deflated state of the plurality of inflatable channels, the distal opening of the central lumen has a first cross-sectional dimension,
wherein, in the inflated state of the plurality of inflatable channels, the distal opening of the central lumen has a second cross-sectional dimension different from the first cross-sectional dimension ([0128] expansion of expandable structures controls steering and movement of the inner portion by expanding inward).
Regarding claim 12, Zhao teaches The medical device of claim 11,
wherein the second cross-sectional dimension is less than the first cross-sectional dimension ([0128] expansion of expandable structures controls steering and movement of the inner portion by expanding inward),
wherein a transition of the plurality of inflatable channels from the deflated state to the inflated state causes the distal opening of the central lumen to transition from having the first cross-sectional dimension to having the second cross-sectional dimension ([0128], One or more of the pressure balloons may be selectively expanded and/or expanded to different degrees (e.g., by using different inflation pressures) such that the distal tip of the inner tube may be turned in a desired direction, per fig. 14, the inner member 5 extends out the tip of the outer member 3, hence the deflection of the distal tip of the inner member 5 would be effected by the inflation of the balloon at the distal tip of the outer member and changing its cross-sectional dimension).
Regarding claim 14, Zhao teaches The medical device of claim 12,
wherein each of the plurality of inflatable channels has a proximal opening configured to receive fluid from a fluid source ([0129], medium channel 34 fills balloons with medium which must originate from an outside source).
Regarding claim 15, Zhao teaches The medical device of claim 14 further comprising:
a port and a port channel extending from the port, wherein the port channel is in fluid communication with the proximal openings of each of the plurality of inflatable channels ([0129], medium channel 34 fills balloons with medium which must originate from an outside source).
Regarding claim 18, Zhao teaches A medical device comprising:
a handle (fig. 14, element 52, [0123] control unit or system 52 disposed at the proximal end of the tube);
a shaft (fig. 2a, element 1, [0104], distal portion of deice 1) extending from the handle, the shaft including a plurality of lumens or channels (fig. 17a, element 30a-c, [0128], pressure balloons 30a-c) extending to a distal end of the shaft, wherein the plurality of lumens or channels comprises:
a central lumen ([0128], pressure balloons have lumen) extending to a distal opening at the distal end of the shaft, and an interior inflatable channel ([0128], inflation of balloons controls expansion) positioned within a body of the shaft, wherein the interior inflatable channel extends from a proximal opening to a closed distal end at the distal end of the shaft,
wherein the interior inflatable channel is inflatable to decrease a cross-sectional dimension of the distal opening of the central lumen ([0128] expansion of expandable structures controls steering and movement of the inner portion by expanding inward).
Regarding claim 21, Zhao teaches The medical device of claim 12,
Further, Zhao teaches wherein each of the plurality of inflatable channels extends longitudinally along, and is adhered to or integrally formed with, an interior surface of a body of the shaft (fig. 17d, element 31a-d, [0128], the controllably expandable structures may comprise four pressure chambers 31a, 316, 31c, and 31 d, e.g., as motor chambers and/or steering chambers. Pressure chambers being integral structures), the interior surface defining the central lumen, and wherein each of the plurality of inflatable channels is inflatable to protrude radially inward relative to the interior surface, toward a central longitudinal axis of the shaft, to transition the central lumen from having the first cross-sectional dimension to having the second cross-sectional dimension ([0128], controllably expandable structures configured to expand or contract, thereby effecting the sliding movement between the outer member and the inner member and/or effecting articulation of the distal portion in a direction transverse to the longitudinal axis of the body portion of the inner tube. Deflection or effecting the sliding movement caused by expansion of the balloons and changing the cross sectional area of the inner lumen).
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.
Claim(s) 1-10, 16, 17, 19, 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhao in view of Ratnakar (US 20090023998 A1).
Regarding claim 1, Zhao teaches A medical device comprising:
a handle (fig. 14, element 52, [0123] control unit or system 52 disposed at the proximal end of the tube);
a shaft (fig. 2a, element 1, [0104], distal portion of deice 1) extending from the handle, the shaft including a plurality of lumens or channels (fig. 17a, element 30a-c, [0128], pressure balloons 30a-c) extending longitudinally through the shaft to a distal end of the shaft, wherein the plurality of lumens or channels comprises:
a central lumen ([0128], pressure balloons have lumen), and
an inflatable channel that is inflatable to decrease a cross-sectional dimension of the central lumen ([0128], inflation of balloons controls expansion);
Zhao does not explicitly teach an inflatable module including a camera, wherein the inflatable module is inflatable to alter a viewing angle of the camera.
However, Ratnakar teaches an inflatable module (fig. 19, element 220, [0064], balloon 220) including a camera (fig. 19, element 52, [0064], rear image lens 52), wherein the inflatable module is inflatable to alter a viewing angle of the camera ([0064], inflation of the balloon deploys the rear view module).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Zhao to include an inflatable camera module as taught in Ratnakar in order to provide a rear view of the device in vivo in addition to the front view (Ratnakar [0064]).
Regarding claim 2, Zhao in view of Ratnakar teaches The medical device of claim 1,
Further, Zhao teaches wherein, inflating the inflatable channel causes the inflatable channel to protrude radially inward toward a central longitudinal axis of the shaft (fig. 17a, pressure balloons 30a-c protrude inwardly).
Regarding claim 3, Zhao in view of Ratnakar teaches The medical device of claim 1,
Further, Zhao teaches wherein the inflatable channel is positioned within a body of the shaft (fig. 18, element 33, [0129], shaft outer member 33 contains pressure balloons 32a-d).
Regarding claim 4, Zhao in view of Ratnakar teaches The medical device of claim 1,
Further, Zhao teaches wherein the inflatable channel is adhered to or integrally formed with an inner surface of a body of the shaft (fig. 17c/d, element 31a-d, [0128], pressure chambers 31a-d are functional equivalents to pressure balloons and are integral to the outer member).
Regarding claim 5, Zhao in view of Ratnakar teaches the medical device of claim 4,
Further, Zhao teaches wherein the inner surface of the body of the shaft defines the central lumen (fig. 18, element 33, [0129], outer member 33 and inner member 35 have a space between that is filled at least partially by pressure balloons 32a-d).
Regarding claim 6, Zhao in view of Ratnakar teaches The medical device of claim 1,
Further, Zhao teaches wherein the central lumen has a distal opening at a distalmost end of the shaft, wherein the inflatable channel has a closed distal end at the distalmost end of the shaft (fig. 18, element 35/32a-d, [0131] balloons 32a-d are shown to terminate in closed ends, whereas inner member 35 extends).
Regarding claim 7, Zhao in view of Ratnakar teaches The medical device of claim 1
Zhao teaches further comprising:
a port in fluid communication with the inflatable channel, wherein the port is positioned at a proximal end of the inflatable channel ([0129], medium channel 34 fills balloons with medium which must originate from an outside source).
Regarding claim 8, Zhao in view of Ratnakar teaches The medical device of claim 1,
Further, Ratnakar teaches wherein the shaft further includes an exterior inflatable channel (fig. 19, element 220, [0064], inflatable balloon 220) extending longitudinally along an exterior surface of the shaft from a proximal opening of the exterior inflatable channel to a closed distal end of the exterior inflatable channel.
Regarding claim 9, Zhao in view of Ratnakar teaches The medical device of claim 8,
Further, Ratnakar teaches wherein the exterior inflatable channel is adhered to or integrally formed with the exterior surface of a body of the shaft ([0064], balloon is attached to the distal part of the endoscope sheath).
Regarding claim 10, Zhao in view of Ratnakar teaches The medical device of claim 8,
Further, Ratnakar teaches wherein inflating the exterior inflatable channel articulates a distal portion of the shaft ([0064], inflation of the balloon articulates the camera and light module 52/53, which are portions at the distal end of the shaft).
Regarding claim 16, Zhao teaches The medical device of claim 11,
Zhao does not explicitly teach wherein the shaft further includes an exterior inflatable channel extending longitudinally along an exterior surface of a body of the shaft from a proximal opening of the exterior inflatable channel to a closed distal end of the exterior inflatable channel.
However, Ratnakar teaches wherein the shaft further includes an exterior inflatable channel (fig. 19, element 220, [0064], inflatable balloon 220) extending longitudinally along an exterior surface of a body of the shaft from a proximal opening of the exterior inflatable channel to a closed-distal end of the exterior inflatable channel.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Zhao to include an inflatable camera module as taught in Ratnakar in order to provide a rear view of the device in vivo in addition to the front view (Ratnakar [0064]).
Regarding claim 17, Zhao in view of Ratnakar teaches The medical device of claim 16,
Further, Ratnakar teaches wherein inflating the exterior inflatable channel articulates a distal portion of the shaft ([0064], inflation of the balloon articulates the camera and light module 52/53, which are portions at the distal end of the shaft).
Regarding claim 19, Zhao teaches The medical device of claim 18,
Zhao does not explicitly teach wherein the plurality of lumens or channels further comprises a first exterior channel extending along an exterior surface of the body of the shaft, wherein inflating the first exterior channel articulates a distal portion of the shaft.
However, Ratnakar teaches wherein the plurality of lumens or channels further comprises a first exterior channel ([0064], balloon is attached to the distal part of the endoscope sheath) extending along an exterior surface of the body of the shaft, wherein inflating the first exterior channel articulates a distal portion of the shaft ([0064], inflation of the balloon articulates the camera and light module 52/53, which are portions at the distal end of the shaft).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Zhao to include an inflatable camera module as taught in Ratnakar in order to provide a rear view of the device in vivo in addition to the front view (Ratnakar [0064]).
Regarding claim 20, Zhao in view of Ratnakar teaches The medical device of claim 19 further comprising:
an inflatable module ([0064], balloon is attached to the distal part of the endoscope sheath) including a camera, wherein the inflatable module is inflatable to alter a viewing angle of the camera [0064], inflation of the balloon articulates the camera and light module 52/53, which are portions at the distal end of the shaft),
wherein the plurality of lumens or channels further comprises a second exterior channel extending along the exterior surface of the body of the shaft,
wherein a distal opening of the second exterior channel is in fluid communication with the inflatable module [0064], inflation of the balloon articulates the camera and light module 52/53, which are portions at the distal end of the shaft).
Conclusion
THIS ACTION IS MADE FINAL. 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 TIMOTHY TUAN LUU whose telephone number is (703)756-4592. The examiner can normally be reached Monday-Tuesday, Thursday-Friday.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Carey can be reached at 5712707235. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TIMOTHY TUAN LUU/ Examiner, Art Unit 3795
/MICHAEL J CAREY/ Supervisory Patent Examiner, Art Unit 3795
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