DETAILED ACTION
Response to Amendment
This Office Action is responsive to the amendment filed on 11/24/2025. As indicated by the amendment: claims 1 and 12 have been amended. Claims 1-22 and 30-34 are presently pending in the application.
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.
Claim(s) 1-5, 7-16 and 18-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ouchi et al. (US 2003/0122374 A1) in view of Silverstein et al. (US 5,193,525 A) in view of Schneider et al. (US 2022/0369903 A1).
Regarding claim 1, Ouchi discloses an endoscope sheath system configured to prevent contamination of an endoscope (10), the system comprising: an endoscope sheath device (Fig. 6) comprising: an external sheath (30) having a circular cross-section (Fig. 6; tubular in shape); a cap (31) sealingly coupled to a distal end of the external sheath (30) wherein the cap comprises a distal face that is transparent (par. [0025]); and an internal sheath (32) comprising a catheter (32) extending within the external sheath (30), wherein the internal sheath is sealingly coupled to the cap (31) at a distal end of the internal sheath (32) so that a lumen of the catheter is open through the cap (See Figs. 6-7 and par. [0023]-[0034]).
Although Ouchi discloses that the cap (31) is transparent (par. [0031]), it does not specifically disclose wherein the cap comprises a distal face that is partially transparent and includes a transparent window. Silverstein teaches an analogous endoscope sheath system wherein the cap (70; Figs. 3, 4 and 7B) comprises a distal face that is partially transparent (Fig. 7B - portions 88 are opaque and lens portions 76 are transparent; col. 7, ll. 24-39) and include a transparent window (76; Figs. 3, 4 and 7B). Silverstein teaches providing the opaque portions (88) to the cap in order to block light from entering the camera (54) via the cap thereby preventing glare in the image and so that the view provided to the user represents a true image (abstract). It would have been obvious to provide the opaque portions and lenses of Silverstein to the cap of Ouchi in order to prevent glare in the image captured by the camera of the endoscope, as taught by Silverstein.
Modified Ouchi does not specifically disclose that the cap has an oval cross-section, and that the sheath device has a latch that is configured to engage with a distal end of the endoscope when the cap is compressed to deform from [[an]]the oval cross-section to releasably secure the cap to the distal end of the endoscope, so that the transparent window on the cap is held aligned with a camera on the endoscope. Schneider teaches a coupling mechanism for an endoscopic instrument comprising a deformable portion (20; Fig. 3) that is releasably engaged by a latch to an instrument (10; Fig. 3). Schneider teaches that a deformable portion (20; Fig. 3) having an oval cross-section when it is not coupled the instrument (par. [0062]-[0065]). Schneider also teaches that the deformable portion (20; Fig. 3) has a latch (21; Fig. 3) that is configured to engage with a mating latch on the instrument (18; Fig. 3) when the deformable portion (20; Fig. 3) is compressed to deform the oval cross-section (par. [0065]; Fig. 3) in order to releasably secure the deformable portion to the endoscopic instrument. Schneider teaches that due to changes in cross-sectional shape of the deformable portion and the configuration of the latch, when the deformable portion and instrument are engaged axial play can be restricted or avoided, and rotation between the two structures can be prevented (par. [0067]). It would have been obvious to one having ordinary skill in the art to make the cap deformable and oval in cross-section before it is mounted on the endoscope and provide it with a latch, such that when it is compressed to engage with a mating latch on the endoscope axial play can be restricted or avoided and rotation between the two structures can be prevented, as taught by Schneider, thereby providing a coupling mechanism that ensures that cap does not separate from, move axially on, or rotate about the endoscope unless it uncoupled. Additionally, incorporation of such coupling mechanism provides a configuration wherein the transparent window on the cap is held aligned with a camera on the endoscope, thereby providing proper viewing and image capture during the procedure.
Regarding claim 2, Ouchi in view of Silverstein in view of Schneider disclose the system of claim 1, wherein the catheter (32) comprises a multi-lumen catheter (321/322 and 323; par. [0027]) having a plurality of radially spaced-apart side openings (324-326) at a proximal end region of the internal sheath, wherein each side opening opens into an internal lumen of the multi-lumen catheter (See Figs. 1-5 and par. [0027]-[0028]).
Regarding claim 3, Ouchi in view of Silverstein in view of Schneider disclose the system of claim 2, further comprising a port adapter manifold (20/21) configured to couple to a proximal end region of the multi-lumen catheter to form a plurality of sealed ports in fluid communication with each lumen of the multi-lumen catheter, wherein the port adapter manifold is configured to seal the side openings of the internal sheath (See Figs. 1-5 and par. [0027]-[0028] and [0037]-[0043]).
Regarding claim 4, Ouchi in view of Silverstein in view of Schneider disclose the system of claim 3, wherein the port adapter manifold is configured to seal to the distal ends of each lumen of the multi-lumen catheter before the multi-lumen catheter is removed (See Fig. 1 and par. [0037]-[0043]).
Regarding claim 5, Ouchi in view of Silverstein in view of Schneider disclose the system of claim 3, wherein the port adapter manifold comprises a connector (20/21) configured to be actuated to seal the plurality of sealed ports around the proximal end region of the multi-lumen catheter (See Figs. 6-7 and par. [0027]-[0028] and [0037]-[0043]).
Regarding claim 7, Ouchi in view of Silverstein in view of Schneider disclose the system of claim 1, wherein the proximal end region (320) of the multi lumen catheter is more rigid than a more distal region of the catheter (See Fig. 1 and par. [0027]).
Regarding claim 8, Ouchi in view of Silverstein in view of Schneider disclose the system of claim 2, wherein the proximal end region of the multi-lumen catheter comprises a neck region (211) configured to engage with a port adapter (See Figs. 1 and 6-7 and par. [0034]).
Regarding claim 9, Ouchi in view of Silverstein in view of Schneider disclose the system of claim 3, wherein the port adapter manifold comprises a plurality of sealing gaskets (22a) along a length of a channel configured to receive the proximal end region of the multi-lumen catheter, wherein the sealing gaskets are longitudinally separated from each other to form the plurality of sealed ports (See Figs. 1-5 and par. [0027]-[0028] and [0037]-[0043]).
Regarding claim 10, Ouchi in view of Silverstein in view of Schneider disclose the system of claim 3, wherein the port adapter manifold comprises a catch or lock (211) to secure the proximal end region of the multi-lumen catheter within the port adapter manifold (See Figs. 1 and 6-7 and par. [0034]).
Regarding claim 11, Ouchi in view of Silverstein in view of Schneider disclose the system of claim 3, wherein the port adapter manifold comprises a plurality of valves (15, 16) configured to control passage of fluid through the lumens of the multi-lumen catheter (See Figs. 6-7 and par. [0030]-[0031]).
Regarding claim 12, Ouchi discloses an endoscope system including a fluid-impermeable contamination barrier to prevent contamination of an endoscope (10), the system comprising: an endoscope sheath device (Fig. 6) comprising: an external sheath (30) having a circular cross-section (Fig. 6; tubular in shape) that is configured to extend over the endoscope; an internal sheath (32) comprising one or more lumens (321/322 and 323), the internal sheath configured to extend through a lumen of the endoscope; a cap (31) configured to couple to a distal end of the endoscope, wherein a distal end region of the external sheath (30) is sealed to the cap (31), and further wherein a distal end region of the internal sheath (32) is sealed to the cap (31) so that the one or more lumens (321/322 and 323) of the internal sheath open through the cap (See Figs. 6-7 and par. [0023]-[0034]).
Although Ouchi discloses that the cap (31) is transparent (par. [0031]), it does not specifically disclose wherein the cap comprises a distal face that is partially transparent and includes a transparent window. Silverstein teaches an analogous endoscope sheath system wherein the cap (70; Figs. 3, 4 and 7B) comprises a distal face that is partially transparent (Fig. 7B - portions 88 are opaque and lens portions 76 are transparent; col. 7, ll. 24-39) and include a transparent window (76; Figs. 3, 4 and 7B). Silverstein teaches providing the opaque portions (88) to the cap in order to block light from entering the camera (54) via the cap thereby preventing glare in the image and so that the view provided to the user represents a true image (abstract). It would have been obvious to provide the opaque portions and lenses of Silverstein to the cap of Ouchi in order to prevent glare in the image captured by the camera of the endoscope, as taught by Silverstein.
Modified Ouchi does not specifically disclose that the cap has an oval cross-section, and that the sheath device has a latch that is configured to engage with a distal end of the endoscope when the cap is compressed to deform from [[an]]the oval cross-section to releasably secure the cap to the distal end of the endoscope, so that the transparent window on the cap is held aligned with a camera on the endoscope. Schneider teaches a coupling mechanism for an endoscopic instrument comprising a deformable portion (20; Fig. 3) that is releasably engaged by a latch to an instrument (10; Fig. 3). Schneider teaches that a deformable portion (20; Fig. 3) having an oval cross-section when it is not coupled the instrument (par. [0062]-[0065]). Schneider also teaches that the deformable portion (20; Fig. 3) has a latch (21; Fig. 3) that is configured to engage with a mating latch on the instrument (18; Fig. 3) when the deformable portion (20; Fig. 3) is compressed to deform the oval cross-section (par. [0065]; Fig. 3) in order to releasably secure the deformable portion to the endoscopic instrument. Schneider teaches that due to changes in cross-sectional shape of the deformable portion and the configuration of the latch, when the deformable portion and instrument are engaged axial play can be restricted or avoided, and rotation between the two structures can be prevented (par. [0067]). It would have been obvious to one having ordinary skill in the art to make the cap deformable and oval in cross-section before it is mounted on the endoscope and provide it with a latch, such that when it is compressed to engage with a mating latch on the endoscope axial play can be restricted or avoided and rotation between the two structures can be prevented, as taught by Schneider, thereby providing a coupling mechanism that ensures that cap does not separate from, move axially on, or rotate about the endoscope unless it uncoupled. Additionally, incorporation of such coupling mechanism provides a configuration wherein the transparent window on the cap is held aligned with a camera on the endoscope, thereby providing proper viewing and image capture during the procedure.
Regarding claim 13, Ouchi in view of Silverstein in view of Schneider disclose the system of claim 12, wherein the internal sheath (32) comprises a multi-lumen catheter (321/322 and 323; par. [0027]).
Regarding claim 14, Ouchi in view of Silverstein in view of Schneider disclose the system of claim 12, wherein the internal sheath (32) comprises a plurality of radially spaced-apart side openings (324-326) at a proximal end region of the internal sheath, wherein each side opening opens into an internal lumen of the internal sheath (See Figs. 1-5 and par. [0027]-[0028]).
Regarding claim 15, Ouchi in view of Silverstein in view of Schneider disclose the system of claim 1,4 wherein the side openings (324-326) are longitudinally spaced-apart along the proximal region of the internal sheath (See Figs. 1-5 and par. [0027]-[0028]).
Regarding claim 16, Ouchi in view of Silverstein in view of Schneider disclose the system of claim 13, further comprising a port adapter manifold (20/21) comprising an internal channel configured to receive a proximal end region of the internal sheath to form a plurality of sealed ports in fluid communication with each lumen of the internal sheath, further wherein the port adapter manifold comprises a connector (20/21) configured to be actuated to seal the plurality of sealed ports around the proximal end region of the multi-lumen catheter (See Figs. 6-7 and par. [0027]-[0028] and [0037]-[0043]).
Regarding claim 18, Ouchi in view of Silverstein in view of Schneider disclose the system of claim 12, wherein the proximal end region (320) of the internal sheath is more rigid than a more distal region of the internal sheath (See Fig. 1 and par. [0027]).
Regarding claim 19, Ouchi in view of Silverstein in view of Schneider disclose the system of claim 12, wherein the proximal end region of the internal sheath comprises a neck region (211) configured to engage with a port adapter (See Figs. 1 and 6-7 and par. [0034]).
Regarding claim 20, Ouchi in view of Silverstein in view of Schneider disclose the system of claim 16, wherein the port adapter manifold comprises a plurality of sealing gaskets (22a) along a length of a channel configured to receive the proximal end region of the internal sheath, wherein the sealing gaskets are longitudinally separated from each other to form the plurality of sealed ports (See Figs. 1-5 and par. [0027]-[0028] and [0037]-[0043]).
Regarding claim 21, Ouchi in view of Silverstein in view of Schneider disclose the system of claim 16, wherein the port adapter manifold comprises a catch or lock (211) to secure the proximal end region of the internal sheath within the port adapter manifold (See Figs. 1 and 6-7 and par. [0034]).
Regarding claim 22, Ouchi in view of Silverstein in view of Schneider disclose the system of claim 16, wherein the port adapter manifold comprises a plurality of valves (15, 16) configured to control passage of fluid through the lumens of the internal sheath (See Figs. 6-7 and par. [0030]-[0031]).
Claim(s) 6 and 17is/are rejected under 35 U.S.C. 103 as being unpatentable over Ouchi in view of Silverstein in view of Schneider, as applied to the claims above, in further view of Howell et al. (US 2002/0049423).
Regarding claim 6, Ouchi in view of Silverstein in view of Kikawada disclose the system of claim 5, but does not specifically disclose wherein the connector comprises a Tuohy connector. The use of Tuohy-Borst fitting/adapters are considered well known to one of ordinary skill in the art of endoscopes and working channels thereof. As evident by Howell, a Tuohy-Borst fitting is provided at the proximal end of a working channel to prevent unwanted fluid loss from the proximal end of the channel (See Figs. 1-2 and par. [0010]). It would have been obvious to one skilled in the art at the time the invention was filed to modify the connector of Ouchi to comprise a Tuohy-Borst fitting to prevent fluid loss as taught by Howell and as is extremely well known in the art.
Regarding claim 17, Ouchi in view of Silverstein in view of Kikawada disclose the system of claim 16, but does not specifically disclose wherein the connector comprises a Tuohy connector. The use of Tuohy-Borst fitting/adapters are considered well known to one of ordinary skill in the art of endoscopes and working channels thereof. As evident by Howell, a Tuohy-Borst fitting is provided at the proximal end of a working channel to prevent unwanted fluid loss from the proximal end of the channel (See Figs. 1-2 and par. [0010]). It would have been obvious to one skilled in the art at the time the invention was filed to modify the connector of Ouchi to comprise a Tuohy-Borst fitting to prevent fluid loss as taught by Howell and as is extremely well known in the art.
Claim(s) 30-34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ouchi in view of Silverstein in view of Kikawada, as applied to the claims above, in further view of Inoue (US 4967732).
Regarding claim 30, Ouchi discloses an endoscope apparatus including a fluid-impermeable contamination barrier to prevent contamination of an endoscope (10), the apparatus comprising: an external sheath (30) configured to extend over the endoscope; an internal sheath (32) comprising one or more lumens (321/322 and 323), the internal sheath configured to extend through a lumen of the endoscope; a cap (31) configured to couple to a distal end of the endoscope, wherein a distal end region of the external sheath (30) is sealed to the cap (31), and further wherein a distal end region of the internal sheath (32) is sealed to the cap (31) so that the one or more lumens (321/322 and 323) of the internal sheath open through the cap (See Figs. 6-7 and par. [0023]-[0034])
Although Ouchi discloses that the cap (31) is transparent (par. [0031]), it does not specifically disclose wherein the cap comprises a distal face that is partially transparent and includes a transparent window; a latch that is configured to engage with a distal end of the endoscope when the cap is deformed to releasably secure the cap to the distal end of the endoscope, so that the transparent window on the cap is held aligned with a camera on the endoscope. Silverstein teaches an analogous endoscope sheath system wherein the cap (70; Figs. 3, 4 and 7B) comprises a distal face that is partially transparent (Fig. 7B - portions 88 are opaque and lens portions 76 are transparent; col. 7, ll. 24-39) and include a transparent window (76; Figs. 3, 4 and 7B). Silverstein teaches providing the opaque portions (88) to the cap in order to block light from entering the camera (54) via the cap thereby preventing glare in the image and so that the view provided to the user represents a true image (abstract). It would have been obvious to provide the opaque portions and lenses of Silverstein to the cap of Ouchi in order to prevent glare in the image captured by the camera of the endoscope, as taught by Silverstein. Silverstein also teaches the cap (70) having a latch (170/172; Fig. 7B) that is configured to deform to releasably secure the cap (70) on the distal end of the endoscope under tension, so that the transparent window on the cap is held aligned with a camera on the endoscope (col. 7, ll. 40-61). Silverstein teaches that the latch (170/172) holds the position of the cap (70) on the endoscope throughout the medical procedure, such that the cap does not separate from the endoscope unless it is intentionally removed (col. 7, ll. 40-61). It would have been obvious to one having ordinary skill in the art to provide a latch on the cap of Ouchi in order to hold the position of the cap on the endoscope throughout the medical procedure, such that the cap does not separate from the endoscope unless it is intentionally removed, as taught by Silverstein, thereby ensuring proper viewing and image capture during the procedure.
Modified Ouchi does not specifically disclose that the cap is compressed to deform from an oval cross-section. Kikawada teaches an analogous cap (30; Fig. 1) that is configured to engage with an endoscope (10; Fig. 1). Kikawada teaches that the cap (30) is elliptical in cross-section when it is not mounted on the endoscope (col. 5, ll. 3-5). Kikawada teaches that when cap is connected to the endoscope, all portions are deformed from the elliptical shape to engage the endoscope (col. 5, ll. 23-28; Fig. 2). It would have been obvious to one having ordinary skill in the art to make the portion of the cap comprising the latch (170/172) elliptical in cross-section before it is mounted on the endoscope and compress it to a circular shape when it is connected to the endoscope, as taught by Kikawada, thereby easily deforming the shoulder, as taught by Silverstein, for the locking snap engagement between the cap and the endoscope.
Ouchi does not specifically disclose to a reinforcement reinforcing at least the distal end region of the internal sheath to prevent collapse when bending the internal sheath. Inoue teaches of an analogous removable internal channel of an endoscope (See Figs. 1-3) that comprises a reinforcement coil (52) received in a spiral groove formed in the outer peripheral surface of the resin tube. It would have been obvious to one skilled in the art at the time the invention was filed to modify the inner sheath of Ouchi. to include a reinforcement coil thereon, to prevent the internal sheath from being deformed or crushed radially when the endoscope is bent as taught by Inoue.
Regarding claim 31, Ouchi in view of Silverstein in view of Kikawada in view of Inoue disclose the apparatus of claim 30, wherein the reinforcement comprises a reinforcement coil (Inoue: 52).
Regarding claim 32, Ouchi in view of Silverstein in view of Kikawada in view of Inoue disclose the apparatus of claim 30, wherein the reinforcement extends over just a distal portion of a length of the internal sheath (Inuoe: the reinforcement coil 52 may be wound around the portion of the resin tube corresponding to the bendable portion).
Regarding claim 33, Ouchi in view of Silverstein in view of Kikawada disclose the system of claim 1, but does not specifically disclose it further comprising a reinforcement reinforcing a least a portion of the internal sheath, the reinforcement comprises a reinforcing coil. Inoue teaches of an analogous removable internal channel of an endoscope (See Figs. 1-3) that comprises a reinforcement coil (52) received in a spiral groove formed in the outer peripheral surface of the resin tube. It would have been obvious to one skilled in the art at the time the invention was filed to modify the inner sheath of Ouchi. to include a reinforcement coil thereon, to prevent the internal sheath from being deformed or crushed radially when the endoscope is bent as taught by Inoue.
Regarding claim 34, Ouchi in view of Silverstein in view of Kikawada in view of Inoue disclose the system of claim 33, wherein the reinforcement extends over just a distal portion of a length of the internal sheath (Inuoe: the reinforcement coil 52 may be wound around the portion of the resin tube corresponding to the bendable portion).
Response to Arguments
Applicant’s arguments, see claim amendments, filed 11/2642025, with respect to the rejection(s) of claim(s) 1 and 12 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Schneider, as discussed above. However, Applicant’s arguments with respect to the rejection(s) of claim(s) 30 under 35 USC 103 have been fully considered and are not persuasive. Applicant contends that Kikawada does not teach a cap, such that it cannot suggest "a cap having an oval cross-section that is sealingly coupled to a distal end of the external sheath" or "a latch that is configured to engage with a distal end of the endoscope when the cap is compressed to deform from an oval cross-section to releasably secure the cap to the distal end of the endoscope" (see Remarks at pages 8-10). The Examiner respectfully disagrees and asserts that cap (32/30) of Kikawada is a cap as it is a covering structure that covers the distal end of the endoscope. Additionally, and as discussed above, Kikawada teaches that the cap has an oval cross-section and is sealingly coupled to a distal end of the external sheath (either 34 or a proximal portion of 32/34). Contrary to that contended by Applicant, the Examiner has not suggested that Kikawada teaches a latch. Accordingly, as Kikawada teaches a cap the arguments are not persuasive and the rejection is maintained. The Examiner recommends amending the claim to include more structural features that patentably distinguish the apparatus over the prior art.
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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/RYNAE E BOLER/Examiner, Art Unit 3795
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
3/3/26