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 Amendment filed 8/26/2026 has been entered. Claims 41,43-57, 59, 60, 62, 65, 66 are pending in the application with claims 41, 60 amended, claims 1-40, 42, 58, 61, 63, 64 cancelled.
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.
Claims 41, 43-47, 49, 53, 54, 60, 62, 65 and 66 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by (JP 5-972599, hereinafter JP1).
In regard to claim 41, JP1 discloses a cover (70, Fig. 1a) for a shaft of a medical scoping device (100), the medical scoping device comprising a visualization system having a field of view (Fig. 4), the cover comprising:
a body member (71) arranged for application over a distal end of the shaft of the medical scoping device (Fig. 4) and, in use, extending along a portion of a length of the distal end of the shaft of the medical scoping device (Fig. 4); and
a plurality of projecting elements (72A-72H) each of the projecting elements having a length extending away from the body member (Fig. 1a), having a longitudinal axis, and being arranged around the body member (Fig. 1a), wherein
at least one of the projecting elements (72g) comprises a measurement scale (g,73g) configured to enable visual comparison for polyp sizing within the field of view of the medical scoping device (via spacing between g and 73g, Fig. 2),
the at least one of the projecting elements is configured to bend to a deflected position in which the measurement scale is within the field of view of the visualization system of the medical scoping device during withdrawal of the medical scoping device through a colon (Fig. 4), and
the measurement scale is provided only on a distal half of the length of the projecting element (Fig. 2).
In regard to claim 43, JP1 teaches wherein each projecting element comprises a base portion (via proximal section), a distal tip (distal section (73a-73h)), and an intermediate portion (via middle section of each projecting element), the intermediate portion being between the base portion and the distal tip (Fig. 2), and
wherein the at least one projecting elements is deflected into the field of view of the visualization system of the medical scoping device at least in part through bending of the at least one of the distal tip and the intermediate portion of the projecting element (Figs. 1a-1b).
In regard to claim 44, JP1 teaches wherein the at least one projecting element has a length and the length of the at least one projecting element is dimensioned so that the distal tip of the projecting element extends beyond a distal end of the medical scoping device when the projecting element is in the deflected position (Fig. 4).
In regard to claim 45, JP1 teaches wherein the projecting elements are spaced apart in a ring around the body member (Figs. 1a-1b), and
wherein the ring is spaced from a distal edge of the body member by a distance that is less than the length of the projecting elements (the ring is spaced from the proximal edge of the body member, Figs. 1a-1b).
In regard to claim 46, JP1 teaches wherein the projecting elements are evenly spaced around the circumference of the body member (Figs. 1a-1b).
In regard to claim 47, JP1 teaches wherein the ring is located no more than 10 mm from a distal edge of the body member (the ring is directly adjacent the distal edge).
In regard to claim 49, JP1 teaches wherein an aspect ratio of a length of the projecting element and a width of the projecting element is no less than three (Figs. 1a,1b).
In regard to claim 53, JP1 teaches wherein the number of the projecting elements is at least six (Fig. 1a,1b).
In regard to claim 54, JP1 teaches wherein the cover is of an elastomeric polymer selected from elastomeric polyesters, copolyesters, polyamides, polyolefins, silicones, polyetherketones, natural rubbers, synthetic rubbers, and styrene polymers, and copolymers or mixtures of any of the aforementioned.
In regard to claim 60, JP1 teaches medical scoping device (100,70) comprising a visualization system (100) having a field of view and a cover (70), wherein the cover comprises:
a body member (71) arranged for application over a distal end of the medical scoping device (Fig. 4) and, in use, extending along a portion of the length of the distal end of the medical scoping device (Fig. 4); and
a plurality of projecting elements (72A-72H) each of the projecting elements having a length extending away from the body member, having a longitudinal axis, and being arranged around the body member (Figs. 1a,1b,2), wherein
at least one of the projecting elements comprises a measurement scale (g,73g) configured to enable visual comparison for polyp sizing within the field of view of the medical scoping device (via spacing between g and 73g helps determine size of objects within a body cavity, Fig. 2),
said at least one of the projecting elements is configured to bend to a deflected position in which the measurement scale is within the field of view of the visualization system of the medical scoping device during withdrawal of the medical scoping device through a colon (Figs. 1a,1b,4), and
the measurement scale is provided only on a distal half of the length of the projecting element (Fig. 2).
In regard to claim 62, JP1 teaches wherein the measurement scale comprises at least two bumps each comprising a respective ridge having a longitudinal axis extending perpendicular to the longitudinal axis of the projecting element, and being spaced apart from one another, each respective ridge being formed as a monolithic structure with the projecting element (via bumps (g, 73g) can be considered ridges and would have longitudinal axis perpendicular to the projecting element, Figs. 1a-1b),
wherein said at least one of the projecting elements is configured to move to the deflected position in which each of the at least two bumps is within the field of view of the visualization system of the medical scoping device during withdrawal of the medical scoping device through a colon, the at least two bumps being provided only on the distal half of the projecting element (Figs. 1a,1b,4).
In regard to claim 65, JP1 teaches wherein the medical scoping device is a colonoscope (Fig. 4).
In regard to claim 66, JP1 teaches wherein in the deflected position a circumferential gap extends between the at least one projecting element and a second, immediately adjacent, projecting element, the circumferential gap extending along at least a portion of the length of the at least one projecting element in the distal half of the at least one projecting element such that the gap is adjacent the measurement scale (Figs. 1a,1b).
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 41, 43-47, 49, 53, 57, 60, 65 and 66 are rejected under 35 U.S.C. 103 as being unpatentable over Kuhns et al. (US Patent Application Publication No. 2007/0149845, hereinafter Kuhns).
In regard to claim 41, Kuhns discloses a cover (10) for a shaft of a medical scoping device, the medical scoping device comprising a visualization system having a field of view (Par. 61), the cover comprising:
a body member (12) arranged for application over a distal end of the shaft of the medical scoping device and, in use, extending along a portion of a length of the distal end of the shaft of the medical scoping device (Figs. 1-2, Par. 61); and
a plurality of projecting elements (22) each of the projecting elements having a length extending away from the body member, having a longitudinal axis and being arranged around the body member (Fig. 4A); wherein
at least one of the projecting elements comprises a measurement scale (via markers (25), Fig. 4A) configured to enable visual comparison for polyp sizing within the field of view of the medical scoping device (Par. 44),
the at least one of the projecting elements is configured to bend to a deflected position in which the measurement scale is within the field of view of the visualization system of the medical scoping device during withdrawal of the medical scoping device through a colon (Figs. 2-3), and
the measurement scale is provided only on a distal half of the projecting element (Fig. 4A).
Kuhns does not expressly teach the measurement scale is only on the distal half of the length of the projecting element. However, Kuhns teaches the measurement scale is disposed along an entire length of the projecting element which is an overlapping range with the claimed limitation of the measurement scale only being on the distal half of the length. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists (see 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). Additionally, there’s no statement of criticality for the measurement scale only being on the distal half of the length in which there would be no unexpected results in modifying the measurement scale being along an entire length of the projecting element to only along the distal half of the length of the projecting element.
In regard to claim 43, Kuhns teaches wherein each projecting element (22) comprises a base portion (22a), a distal tip (via end of the projecting element), and an intermediate portion (22b), the intermediate portion being between the base portion and the distal tip (Fig. 4A), and
wherein the at least one projecting elements is deflected into the field of view of the visualization system of the medical scoping device at least in part through bending of the at least one of the distal tip and the intermediate portion of the projecting element (Figs. 2-3).
In regard to claim 44, Kuhns teaches wherein the at least one projecting element has a length and the length of the at least one projecting element is dimensioned so that the distal tip of the projecting element extends beyond a distal end of the medical scoping device when the projecting element is in the deflected position (Figs. 2-3).
In regard to claim 45, Kuhns teaches wherein the projecting elements are spaced apart in a ring around the body member (Fig. 4A), and
wherein the ring is spaced from a distal edge of the body member by a distance that is less than the length of the projecting elements (Fig. 4A).
In regard to claim 46, Kuhns teaches wherein the projecting elements are evenly spaced around the circumference of the body member (Fig. 4A).
In regard to claim 47, Kuhns teaches wherein the ring is located no more than 10 mm from a distal edge of the body member (the arms (22) forms a ring from a proximal end to a distal end of the arms, therefore any location along the arms can be considered the ring which would be no more than 10mm from a distal edge of the body member).
In regard to claim 49, Kuhns teaches wherein an aspect ratio of a length of the projecting element and a width of the projecting element is no less than three (Fig. 4A).
In regard to claim 53, Kuhns teaches wherein the number of the projecting elements is at least six (Fig. 4A).
In regard to claim 57, Kuhns teaches wherein the cover comprises a radio-opaque dye for identification during an examination of a human body (Par. 44, via radiopaque markers (25)).
In regard to claim 60, Kuhns discloses a medical scoping device (10 and colonoscope or laparoscope, Par. 61-62) comprising a visualization system having a field of view and a cover (Fig. 1, Par. 61-62), wherein the cover comprises:
a body member (12, Fig. 2) arranged for application over a distal end of the medical scoping device (Par. 61-62) and, in use, extending along a portion of the length of the distal end of the medical scoping device (Figs. 61-62); and
a plurality of projecting elements (22) each of the projecting elements having a length extending away from the body member, having a longitudinal axis and being arranged around the body member (Fig. 4A); wherein
at least one of the projecting elements comprises a measurement scale (via markers (25), Fig. 4A) configured to enable visual comparison for polyp sizing within the field of view of the medical scoping device (Par. 44),
said at least one of the projecting elements is configured to bend to a deflected position in which the measurement scale is within the field of view of the visualization system of the medical scoping device during withdrawal of the medical scoping device through a colon (Figs. 2-3), and
the measurement scale is provided only on a distal half of the projecting element (Fig. 4A).
Kuhns does not expressly teach the measurement scale is only on the distal half of the length of the projecting element. However, Kuhns teaches the measurement scale is disposed along an entire length of the projecting element which is an overlapping range with the claimed limitation of the measurement scale only being on the distal half of the length. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists (see 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). Additionally, there’s no statement of criticality for the measurement scale only being on the distal half of the length in which there would be no unexpected results in modifying the measurement scale being along an entire length of the projecting element to only along the distal half of the length of the projecting element.
In regard to claim 65, Kuhns teaches wherein the medical scoping device is a colonoscope (Par. 62).
In regard to claim 66, Kuhns teaches wherein in the deflected position a circumferential gap extends between the at least one projecting element and a second, immediately adjacent, projecting element, the circumferential gap extending along at least a portion of the length of the at least one projecting element in the distal half of the at least one projecting element such that the gap is adjacent the measurement scale (Fig. 3 illustrates the projecting elements provide a gap therebetween).
Claims 48 and 51 are rejected under 35 U.S.C. 103 as being unpatentable over Kuhns et al. (US Patent Application Publication No. 2007/0149845, hereinafter Kuhns) in view of Ostrovsky et al. (US Patent Application Publication No. 2017/0112365, hereinafter Ostrovsky).
In regard to claims 48 and 51, Kuhns does not expressly teach teaches wherein the length of the at least one projecting element is no more than 20 mm, wherein the at least one projecting element has a width, and the width of the at least one projecting element is in the range of 1.5mm to 3mm.
Ostrovsky teaches an analogous assembly (17) for use with an endoscope (10) comprising in which the assembly (17) comprises a base (4) with a plurality of struts (3) that extend beyond a distal end of the base and a webbing (2) surrounding the plurality of struts (3) for dilating a body lumen. Ostrovsky teaches the struts having a length in the range of 10-25mm (Par. 102) and the width of the struts being in the range of 2-5mm (Par. 100).
It would’ve been obvious to one of ordinary skill in the art at the effective filing date of the invention to modify the projecting elements (22) of Kuhns to have a length 20mm or less and a width in the range of 1.5-3mm as taught by Ostrovsky as a matter of design choice for effectively expanding and contacting the walls of a body cavity. There being no unexpected results in modifying the size of the projecting elements of Kuhns with size of the struts of Ostrovsky.
Claim 62 is rejected under 35 U.S.C. 103 as being unpatentable over Kuhns et al. (US Patent Application Publication No. 2007/0149845, hereinafter Kuhns) in view of Longo et al. (US Patent Application Publication No. 2007/0249989, hereinafter Longo).
In regard to claim 62, Kuhns does not expressly teach wherein the measurement scale comprises at least two bumps each comprising a respective ridge having a longitudinal axis extending perpendicular to the longitudinal axis of the projecting element, and being spaced apart from one another, each respective ridge being formed as a monolithic structure with the projecting element, wherein said at least one of the projecting elements is configured to move to the deflected position in which each of the at least two bumps is within the field of view of the visualization system of the medical scoping device during withdrawal of the medical scoping device through a colon, the at least two bumps being provided only on the distal half of the projecting element.
Longo teaches an analogous device (10) comprising an inner tube (12) with a plurality of arms or petals (22) projecting from a distal end of the inner tube. The petals are configured to transition between an open configuration in which the arms or petals expand radially outward and a closed configuration in which the arms or petals retract radially inward. The arms or petals are formed with a plurality of detection elements or markers (27) that have the shape of ridge (see Figs. 4,6).
It would’ve been obvious to one of ordinary skill in the art at the effective filing date of the invention to modify the markers (25) of Kuhns with the markers (27) of Longo as a matter of design choice for evaluating pathologies within a body cavity. Additionally, Longo teaches the markers can be numbered to better identify pathology size. There being no unexpected results in substituting the markers of Kuhns for the markers of Longo.
Claims 41 and 43-56 are rejected under 35 U.S.C. 103 as being unpatentable over Ostrovsky et al. (US Patent Application Publication No. 2017/0112365, hereinafter Ostrovsky) in view of Kuhns et al. (US Patent Application Publication No. 2007/0149845, hereinafter Kuhns).
In regard to claim 41, Ostrovsky discloses a cover (17, Fig. 1) for a shaft of a medical scoping device, the medical scoping device (10, Par. 86), the medical scoping device comprising a visualization system having a field of view (endoscopes contain visualization means that would have a field of view), the cover comprising:
a body member (4) arranged for application over a distal end of the shaft of the medical scoping device and, in use, extending along a portion of a length of the distal end of the shaft of the medical scoping device (Par. 58, Fig. 6,7A,7B); and
a plurality of projecting elements (3) each of the projecting elements having a length extending away from the body member, having a longitudinal axis and being arranged around the body member (Figs. 6,7A,7B); wherein
the at least one of the projecting elements is configured to bend to a deflected position in which the projecting elements are within the field of view of the visualization system of the medical scoping device during withdrawal of the medical scoping device through a colon (Fig. 7B illustrates the projecting elements would be within a field of view of the endoscope during withdrawal of the endoscope).
Ostrovsky is silent with respect to at least one of the projecting elements comprises a measurement scale configured to enable visual comparison for polyp sizing within the field of view of the medical scoping device, the measurement scale is provided only on a distal half of the projecting element.
Ostrovsky teaches an analogous device (100, Fig. 7) comprising a tubular body (12) and an expandable tip. The expandable tip comprises a plurality of struts (140, 138) formed of a plurality of arms (140) with petals (138) projecting from the arms. The expandable tip is further surrounded by an expandable membrane (152) in which the tip can expand between open (Fig. 9) and closed (Fig. 8) configurations. The petals (138) comprise a plurality of radiopaque markers (150) formed on the distal half of the struts for measuring the size of pathology within a patient’s body (Par. 104). Moreover as an example the markers have been shown as lines transversal to the development of the petals and distributed along the length of the petal itself even if they may be provided in number, shape and arrangement different from what has been shown as an example (Par. 104).
It would’ve been obvious to one of ordinary skill in the art at the effective filing date of the invention to modify the struts (3) of Ostrovsky with the radiopaque markers (150) on the struts (138,140) as taught by Kuhns enabling a surgeon to measure the size of pathology encountered within a body cavity. There being no unexpected results in providing the radiopaque markers of Kuhns on the struts of Ostrovsky.
Ostrovsky and Kuhns do not expressly teach the measurement scale is only on the distal half of the length of the projecting element. However, Kuhns teaches the measurement scale is disposed along an entire length of the projecting element which is an overlapping range with the claimed limitation of the measurement scale only being on the distal half of the length. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists (see 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). Additionally, there’s no statement of criticality for the measurement scale only being on the distal half of the length in which there would be no unexpected results in modifying the measurement scale being along an entire length of the projecting element to only along the distal half of the length of the projecting element.
In regard to claim 43, Ostrovsky teaches wherein each projecting element (3) comprises a base portion (portion attached to the base (4)), a distal tip (via end of the projecting element), and an intermediate portion (portion between the base portion and distal tip portion), the intermediate portion being between the base portion and the distal tip (Figs. 6,7A,7B), and
wherein the at least one projecting elements is deflected into the field of view of the visualization system of the medical scoping device at least in part through bending of the at least one of the distal tip and the intermediate portion of the projecting element (Figs. 7B, 11).
In regard to claim 44, Ostrovsky teaches wherein the at least one projecting element has a length and the length of the at least one projecting element is dimensioned so that the distal tip of the projecting element extends beyond a distal end of the medical scoping device when the projecting element is in the deflected position (Figs. 7B, 11).
In regard to claim 45, Ostrovsky teaches wherein the projecting elements are spaced apart in a ring around the body member (Figs. 6,7A,7B), and
wherein the ring is spaced from a distal edge of the body member by a distance that is less than the length of the projecting elements (Figs. 6,7A,7B).
In regard to claim 46, Ostrovsky teaches wherein the projecting elements are evenly spaced around the circumference of the body member (Fig. 6).
In regard to claim 47, Ostrovsky teaches wherein the ring is located no more than 10 mm from a distal edge of the body member (Fig. 6, Par. 102).
In regard to claim 48, Ostrovsky teaches wherein the length of the at least one projecting element is no more than 20 mm (Par. 100).
In regard to claim 49, Ostrovsky teaches wherein an aspect ratio of a length of the projecting element and a width of the projecting element is no less than three (Fig. 6, wherein the length of the projecting elements can be 10mm, Par. 102, and the width can be 2mm, Par. 100).
In regard to claim 50, Ostrovsky teaches wherein the cover has an overall diameter and the overall diameter of the cover is no more than 40mm (Par. 69).
In regard to claim 51, Ostrovsky teaches wherein the at least one projecting element has a width, and the width of the at least one projecting element is in the range of 1.5mm to 3mm (Par. 100).
In regard to claim 52, Ostrovsky teaches wherein the cover has a length, and the length of the cover is in the range of 5mm to 16mm (Par. 102).
In regard to claim 53, Ostrovsky teaches wherein the number of the projecting elements is at least six (Figs. 6,7A,7B).
In regard to claims 54-56, Kuhns teaches wherein the cover is of an elastomeric polymer selected from elastomeric polyesters, copolyesters, polyamides, polyolefins, silicones, polyetherketones, natural rubbers, synthetic rubbers, and styrene polymers, and copolymers or mixtures of any of the aforementioned (Par. 66, silicone rubber), wherein the elastomeric polymer is selected from styrene-olefin block copolymers and silicone rubbers (Par. 66, silicone rubber), wherein the cover comprises a polymer material of Shore A hardness from 40 to 60 (Par. 66).
Claim 59 is rejected under 35 U.S.C. 103 as being unpatentable over Ostrovsky et al. (US Patent Application Publication No. 2017/0112365, hereinafter Ostrovsky) in view of Kuhns et al. (US Patent Application Publication No. 2007/0149845, hereinafter Kuhns) as applied to claim 41, and further in view of Bendele et al. (WO 2016/209240 A1, hereinafter Bendele).
In regard to claim 59, Ostrovsky teaches a cover (17) according to claim 41, (see rejection of Claim 41) but does not expressly disclose a set of covers, each cover of the set comprising a colored dye and a color of the dye indicating the type of the cover.
Bendele teaches an analogous endoscopic cover wherein the components of the fitting may be color coded to signify various physical properties. For example, different colors may be used to differentiate between varying amounts of friction or flexibility between components (Par. 141).
It would have been obvious to one skilled in the art at the time the invention was filed to provide various color-coded covers of Ostrovsky et al. to differentiate between varying amounts of friction or flexibility between components as taught by Bendele (Par. 141).
Response to Arguments
Applicant’s arguments with respect to claim(s) 41, 43-57, 59, 60, 62, 65, 66 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
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/RYAN N HENDERSON/Primary Examiner, Art Unit 3795 September 11, 2026
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