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 .
Notice of Amendment
The RCE filed 10/27/2025 has been entered. Claims 1-11 and 14 are pending, with claims 1, 8, 9, 14 amended, claims 12, 13, 15-30 cancelled.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-10 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Roychowdhury et al. (US Patent Application Publication No. 2020/0060518, hereinafter Roychowdhury) in view of Axon (US Patent Application Publication No. 2013/0090527).
In regard to claim 1, Roychowdhury discloses a support device (10, Figs. 1,21) for an endoscope having a distal end (Par. 132), the support device comprising:
a tubular member (20,30) configured for removable attachment to an outer surface of the endoscope near, or at, the distal end, the tubular member having a distal peripheral outer surface surrounding an opening (Fig. 3, Par. 136);
distal and proximal rings of projecting elements (22, 32) extending outward from the outer surface of the tubular member, the projecting elements within the distal and proximal rings being spaced from each other around a circumference of the tubular member to define gaps therebetween (Fig. 2), wherein the distal ring is spaced longitudinally from the proximal ring and wherein the projecting elements of the proximal ring are aligned longitudinally with the gaps between the projecting elements in the distal ring (Fig. 2); and
Roychowdury teaches the projecting elements are spaced 1 mm to about 20 mm from the distal end in Par. 165, wherein the present claim recites wherein the projecting elements of the distal ring are spaced from a distal end of the tubular member by a distance of greater than 20 mm. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Since Roychowdery recites 1 mm to about 20 mm, the ranges overlap since about 20 mm covers slightly below 20 mm and slightly above 20 mm, therefore reading on greater than 20 mm. Additionally, Roychowdury does not expressly teach an optically transparent cover coupled to the tubular member, extending from the distal peripheral outer surface across the opening, and configured for covering the distal end of the endoscope when the tubular member is attached to the outer surface of the endoscope.
Axon teaches an analogous cover (1, Figs. 1-3) for an endoscope for aiding advancement and withdrawal of an endoscope within a body cavity. The cover (1) includes an tubular member (3) having a plurality of projecting elements (2) on the tubular member and a transparent cap (13) at a distal tip of the cover tubular member (3) enabling an endoscope to view through the transparent cover (Par. 94).
It would’ve been obvious to one of ordinary skill in the art at the effective filing date of the invention to provide the support device of Roychowdury with the transparent cap (13) of Axon thereby limiting distal advancement of the endoscope within the support device as well as providing image focus and correct depth of field for the endoscope (Par. 75, 94).
In regard to claim 2, Roychowdury and Axon teaches wherein the cover is spaced from the distal end of the endoscope when the tubular member is attached to the outer surface of the endoscope (The distal end of the endoscope contacts lip (19) and would therefore be spaced from the cover (13) of Axon. Additionally, the endoscope does not have to be fully inserted within the tubular member since ribs (18) on the interior of the tubular body aid in gripping the endoscope).
In regard to claim 3, Roychowdury teaches wherein the endoscope has a lens at the distal end of the endoscope, and wherein the cover is spaced from the lens by a length less than a minimum focal distance of the endoscope (the lens of an endoscope is capable of being spaced from the cover by a length less than a minimum focal distance of the endoscope).
In regard to claim 4, Axon teaches wherein the cover and the tubular member create a seal over the distal end of the endoscope (the cap (13) of Axon encloses the tubular member and therefore would create a seal).
In regard to claim 5, Roychowdury and Axon teaches wherein the cover is integral with the tubular member to form a unitary body (the end cap (13) of Axon is fixedly retained on the tubular body and is thereby integral with the tubular member to form a unitary body).
In regard to claim 6, Roychowdury teaches wherein the tubular member has an inner surface configured for gripping the outer surface of the endoscope (Par. 133, via ribs (18)).
In regard to claim 7, Roychowdury teaches wherein each of the projecting elements comprise a base (28,38) coupled to the tubular member and a substantially flexible arm (22, 32) extending from the base (Fig. 4).
In regard to claim 8, Roychowdury teaches wherein the flexible arm of each projecting element is movable between a first position, wherein the flexible arm is substantially parallel to a longitudinal axis of the tubular member, to a second position, wherein the flexible arm extends transversely to the longitudinal axis of the tubular member (the flexible arms (22, 32) are capable of deflecting between being first and second positions, wherein in a first position the flexible arms can be bent to be parallel to the longitudinal axis and a second position in which the arms are unbent or only partially bent to be transverse to the longitudinal axis).
In regard to claim 9, Roychowdury teaches wherein the flexible arm of each projecting element is movable between a first position, wherein the flexible arm is substantially parallel to a longitudinal axis of the tubular member, to a second position, wherein the flexible arm extends substantially perpendicular to the longitudinal axis of the tubular member (the flexible arms (22, 32) are capable of deflecting between being first and second positions, wherein in a first position the flexible arms can be bent to be parallel to the longitudinal axis and a second position in which the arms are unbent to be perpendicular to the longitudinal axis)
In regard to claim 10, Roychowdury teaches wherein each of the distal and proximal rings of projecting elements comprise further comprising about 2 to about 20 projecting elements (Fig. 1).
In regard to claim 14, Roychowdhury teaches each ring (22, 32) is spaced apart from each other by from about 0.25 cm to about 2.5 cm in Par. 140. The present claims recite wherein the distal ring of projecting elements is spaced from the proximal ring of projecting elements by a distance of greater than about 2.5 cm.
In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Since the claim recites greater than about 2.5 cm and the prior art recites 1 cm to about 2.5cm, the ranges overlap since about 2.5 cm covers slightly below 2.5 cm and slightly above 2.5 cm.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Roychowdhury et al. (US Patent Application Publication No. 2020/0060518, hereinafter Roychowdhury) in view of Axon (US Patent Application Publication No. 2013/0090527), as applied to claim 1, and further in view of Dubi et al. (US Patent Application Publication No. 2010/0256447, hereinafter Dubi).
In regard to claim 11, Roychowdhury does not expressly teach further comprising one or more sensors on the tubular member or cover for detecting a physiological parameter in a patient.
Dubi teaches an analogous endoscopic sleeve for insertion within a colon of a patient. The endoscopic sleeve contains one or more pressure sensors along the sleeve for detecting intra-colonic luminal pressure (Par. 115).
It would’ve been obvious to one of ordinary skill in the art at the effective filing date of the invention to provide the tubular member of Roychowdhury with the one or more pressure sensors along the tubular member as taught by Dubi for monitoring intra-colonic luminal pressure while conducting a colonoscopy procedure thereby preventing pressure from exceeding a predetermined level.
Response to Arguments
Applicant's arguments filed 7/2/2026 have been fully considered but they are not persuasive.
Applicant argues:
“The Examiner's basis for the rejection of claim 1 rested on the assertion that the claimed range of "greater than about 20 mm" overlapped with Roychowdhury's disclosed range of "1 mm to about 20 mm," citing In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976) and In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Specifically, the Examiner stated on Page 4 of the Office Action that "[s]ince the claim recites greater than about 20 mm and the prior art recites 1 mm to about 20 mm, the ranges overlap since about 20 mm covers slightly below 20 mm and slightly above 20 mm." Applicant's amendment eliminates the basis for this rejection. Claim 1 now unambiguously recites "a distance of greater than 20 mm" - without the qualifier "about." Accordingly, the claimed range begins exclusively above 20 mm and does not overlap with the 1-20 mm range disclosed in Roychowdhury. Roychowdhury specifically teaches that the first (distal) ring of projecting elements 22 is disposed "1-20 mm from the lip of the distal end" (paragraph [0165]). The claimed distance of "greater than 20 mm" is entirely outside this disclosed range. There is no overlap, and the prima facie case of obviousness based on overlapping ranges under In re Wertheim and In re Woodruff no longer applies.”
The examiner disagrees since Roywchowdhury still teaches an overlapping range since Roychowdhury teaches the range of about 1 mm to about 20 mm, would lie within the range of greater than 20 mm since about 20 mm allows for slight greater than 20mm.
Applicant argues:
“Moreover, Roychowdhury's disclosure of a specific range of 1-20 mm for the distal ring demonstrates that a distance of greater than 20 mm for the distal ring of projecting elements is not merely an obvious design choice. Roychowdhury deliberately constrains the positioning of its distal ring to be within 1-20 mm of the distal end. The claimed invention, in contrast, requires the distal ring to be spaced at a distance of greater than 20 mm - a value that Roychowdhury does not disclose, suggest, or render obvious for the distal ring of projecting elements. While it is true that Roychowdhury's second (proximal) ring 32 may be further than 20 mm from the distal end, this is irrelevant because claim 1 specifically requires the projecting elements of the **distal ring** to be spaced from the distal end of the tubular member by a distance of greater than 20 mm. Roychowdhury teaches no such arrangement for its distal ring.”
The examiner disagrees since Roywchowdhury still teaches an overlapping range since Roychowdhury teaches the range of about 1 mm to about 20 mm, would lie within the range of greater than 20 mm since about 20 mm allows for slight greater than 20mm. Additionally, it has been well defined that the overlapping endpoint of the prior art and claimed range was sufficient to support an obviousness rejection, particularly when there was no showing of criticality of the claimed range (In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)).
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 RYAN N HENDERSON whose telephone number is (571)270-1430. The examiner can normally be reached Monday-Friday 6am-5pm (PST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anhtuan Nguyen can be reached at 571-272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RYAN N HENDERSON/ Primary Examiner, Art Unit 3795 August 18, 2026
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