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 .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 11, 25, and 37 are rejected on the ground of nonstatutory double patenting as being unpatentable over respective Claims 1, 10, 23, and 34 of U.S. Patent No. 12,022,998. Although the claims at issue are not identical, they are not patentably distinct from each other because all elements in Claims 1, 11, 25, and 37 of the present patent application are claimed in respective Claims 1, 10, 23, and 34 of U.S. Patent No. 12,022,998, such that this is an anticipation-type nonstatutory double patenting rejection.
A comparison of present Application 18/761,646 and parent Patent 12/022,998 is shown in the table(s) shown below:
Current application 18/761,646
Parent Patent 12,022,998
Claim 1
Claim 1
Apparatus for inverting an elongated flexible tubular sleeve having a proximal end, a distal end and a central lumen extending between the proximal end and the distal end, the apparatus comprising:
Apparatus for inverting an elongated flexible tubular sleeve having a proximal end, a distal end and a central lumen extending between the proximal end and the distal end, the apparatus comprising:
a hollow tube comprising a proximal end, a distal end and a central lumen extending between the proximal end and the distal end;
a hollow tube comprising a proximal end, a distal end and a central lumen extending between the proximal end and the distal end;
an elongated rod movably disposed within the central lumen of the hollow tube, the elongated rod having a proximal end and a distal end, wherein the distal end of the elongated rod comprises a sleeve plug for securing a distal end of an elongated flexible tubular sleeve to the distal end of the hollow tube;
an elongated rod movably disposed within the central lumen of the hollow tube, the elongated rod having a proximal end and a distal end, wherein the distal end of the elongated rod comprises a sleeve plug for securing a distal end of an elongated flexible tubular sleeve to the distal end of the hollow tube; and
at least one flexible mandrel configured to be passed through at least one support tube formed on an exterior surface of the elongated flexible tubular sleeve;
wherein, when the elongated flexible tubular sleeve is disposed over the hollow tube, (i) the sleeve plug of the elongated rod is configured to be moved proximally to clamp the distal end of the elongated flexible tubular sleeve to the distal end of the hollow tube, and (ii) the sleeve plug of the elongated rod is configured to be moved distally to release the distal end of the elongated flexible tubular sleeve from the distal end of the hollow tube; and
wherein, when the elongated flexible tubular sleeve is disposed over the hollow tube, (i) the sleeve plug of the elongated rod is configured to be moved proximally to clamp the distal end of the elongated flexible tubular sleeve to the distal end of the hollow tube, and (ii) the sleeve plug of the elongated rod is configured to be moved distally to release the distal end of the elongated flexible tubular sleeve from the distal end of the hollow tube; and
further wherein when the distal end of the elongated flexible tubular sleeve is clamped to the distal end of the hollow tube, the proximal end of the elongated flexible tubular sleeve can be pulled toward the distal end of the hollow tube to invert the elongated flexible tubular sleeve.
further wherein when the distal end of the elongated flexible tubular sleeve is clamped to the distal end of the hollow tube, the proximal end of the elongated flexible tubular sleeve can be pulled toward the distal end of the hollow tube to invert the elongated flexible tubular sleeve.
Claim 11
Claim 10
A method for inverting an elongated, flexible tubular sleeve having a proximal end, a distal end and a central lumen extending between the proximal end and the distal end, the method comprising:
A method for inverting an elongated, flexible tubular sleeve having a proximal end, a distal end and a central lumen extending between the proximal end and the distal end, the method comprising:
providing an apparatus comprising:
providing an apparatus comprising:
a hollow tube comprising a proximal end, a distal end and a central lumen extending between the proximal end and the distal end; and
a hollow tube comprising a proximal end, a distal end and a central lumen extending between the proximal end and the distal end; and
an elongated rod movably disposed within the central lumen of the hollow tube, the elongated rod having a proximal end and a distal end, wherein the distal end of the elongated rod comprises a sleeve plug for securing a distal end of an elongated flexible tubular sleeve to the distal end of the hollow tube;
an elongated rod movably disposed within the central lumen of the hollow tube, the elongated rod having a proximal end and a distal end, wherein the distal end of the elongated rod comprises a sleeve plug for securing a distal end of an elongated flexible tubular sleeve to the distal end of the hollow tube;
disposing the elongated flexible tubular sleeve over the hollow tube;
disposing the elongated flexible tubular sleeve over the hollow tube;
moving the elongated rod proximally, whereby to clamp the distal end of the elongated flexible tubular sleeve to the distal end of the hollow tube; and
moving the elongated rod proximally, whereby to clamp the distal end of the elongated flexible tubular sleeve to the distal end of the hollow tube;
pulling the proximal end of the elongated flexible tubular sleeve distally toward the distal end of the elongated flexible tubular sleeve, whereby to invert the elongated flexible tubular sleeve.
pulling the proximal end of the elongated flexible tubular sleeve distally toward the distal end of the elongated flexible tubular sleeve, whereby to invert the elongated flexible tubular sleeve; and
applying a hydrophilic coating to the inverted flexible tubular sleeve.
Claim 25
Claim 23
Apparatus comprising:
Apparatus comprising:
a sleeve adapted to be slid over the exterior of an endoscope, wherein the sleeve comprises a sleeve proximal end, a sleeve distal end and a sleeve lumen extending therebetween, and further wherein the sleeve is configured to be slid over the exterior surface of the endoscope so as that the interior surface of the sleeve lumen substantially covers the exterior surface of the endoscope from a point adjacent to the distal end of the endoscope to a point adjacent to the handle of the endoscope, wherein the interior surface of the sleeve lumen comprises a hydrophilic coating; and
a sleeve adapted to be slid over the exterior of an endoscope, wherein the sleeve comprises a sleeve proximal end, a sleeve distal end and a sleeve lumen extending therebetween, and further wherein the sleeve is configured to be slid over the exterior surface of the endoscope so as that the interior surface of the sleeve lumen substantially covers the exterior surface of the endoscope from a point adjacent to the distal end of the endoscope to a point adjacent to the handle of the endoscope, wherein the interior surface of the sleeve lumen comprises a hydrophilic coating; and
at least one support channel carried by the sleeve, wherein the at least one support channel comprises a channel proximal end, a channel distal end and a channel lumen extending therebetween.
at least one support channel carried by the sleeve, wherein the at least one support channel comprises a channel proximal end, a channel distal end and a channel lumen extending therebetween, and
further wherein the at least one support channel is configured to receive an instrument.
Claim 37
Claim 34
A method for applying a hydrophilic coating to a sleeve adapted to be slid over the exterior of an endoscope, wherein the sleeve comprises:
A method for applying a hydrophilic coating to a sleeve adapted to be slid over the exterior of an endoscope, wherein the sleeve comprises:
a sleeve proximal end, a sleeve distal end and a sleeve lumen extending therebetween, and further wherein the sleeve is configured to be slid over the exterior of the endoscope so as that the interior surface of the sleeve lumen substantially covers the exterior of the endoscope from a point adjacent to the distal end of the endoscope to a point adjacent to the handle of the endoscope; and
a sleeve proximal end, a sleeve distal end and a sleeve lumen extending therebetween, and further wherein the sleeve is configured to be slid over the exterior of the endoscope so as that the interior surface of the sleeve lumen substantially covers the exterior of the endoscope from a point adjacent to the distal end of the endoscope to a point adjacent to the handle of the endoscope; and
at least one support channel carried by the sleeve, wherein the at least one support channel comprises a channel proximal end, a channel distal end and a channel lumen extending therebetween;
at least one support channel carried by the sleeve, wherein the at least one support channel comprises a channel proximal end, a channel distal end and a channel lumen extending therebetween,
and further wherein the at least one support channel is configured to receive at least one from the group consisting of an instrument and a push tube;
wherein the method comprises:
wherein the method comprises:
inverting the sleeve;
inverting the sleeve;
applying the hydrophilic coating to the inverted interior surface of the sleeve lumen;
applying the hydrophilic coating to the inverted interior surface of the sleeve lumen;
allowing the hydrophilic coating to cure; and
allowing the hydrophilic coating to cure; and
reverting the sleeve.
reverting the sleeve.
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 present rejection(s) reference specific passages from cited prior art. However, Applicant is advised that the rejections are based on the entirety of each cited prior art. That is, each cited prior art reference “must be considered in its entirety”. Therefore, Applicant is advised to review all portions of the cited prior art if traversing a rejection based on the cited prior art.
Claims 1, 7, 10-11, 17, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Johnson et al. (US Patent 6,039,721 – “Johnson”) in view of Rahamimov (US PGPUB 2007/0123798 – “Rahamimov”).
Regarding Claim 1, Johnson discloses:
Apparatus for inverting an elongated flexible tubular sleeve (Johnson FIG. 1, balloon 26) having a proximal end, a distal end and a central lumen extending between the proximal end and the distal end, the apparatus comprising:
a hollow tube (Johnson FIG. 1, tube 15) comprising a proximal end, a distal end and a central lumen extending between the proximal end and the distal end; and
an elongated rod (Johnson FIG. 1, guide tube 14) movably disposed within the central lumen of the hollow tube, the elongated rod having a proximal end and a distal end, wherein the distal end of the elongated rod comprises a sleeve plug (Johnson FIG. 1, connection 30) for securing a distal end of an elongated flexible tubular sleeve (Johnson FIG. 1, balloon 26) to the distal end of the hollow tube (Johnson FIG. 1, showing connection 30 pressing distal end of balloon 26 against distal end of tube 15);
wherein, when the elongated flexible tubular sleeve is disposed over the hollow tube, (i) the sleeve plug of the elongated rod is configured to be moved proximally to clamp the distal end of the elongated flexible tubular sleeve to the distal end of the hollow tube (Johnson FIG. 1), and (ii) the sleeve plug of the elongated rod is configured to be moved distally to release the distal end of the elongated flexible tubular sleeve from the distal end of the hollow tube (Johnson FIG. 2).
Johnson does not explicitly disclose wherein when the distal end of the elongated flexible tubular sleeve is clamped to the distal end of the hollow tube, the proximal end of the elongated flexible tubular sleeve can be pulled toward the distal end of the hollow tube to invert the elongated flexible tubular sleeve.
Rahamimov teaches wherein when the distal end of the elongated flexible tubular sleeve is clamped to the distal end of the hollow tube (Rahamimov FIG. 3A, showing distal end of sheath 30 connected to distal end of tube 20), the proximal end of the elongated flexible tubular sleeve can be pulled toward the distal end of the hollow tube to invert the elongated flexible tubular sleeve (Rahamimov FIG. 3C, showing sheath 30 inverting while distal end of tube 20 moves towards proximal end of sheath 30).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to substitute Rahamimov’s sheath orientation for Johnson’s balloon. A person having ordinary skill in the art would be motivated to make this substitution in order to allow the inverted sheath/sleeve to be lubricated (see paragraphs [0077] – [0078] of Rahamimov).
Regarding Claim 7, Johnson in view of Rahamimov teach the features of Claim 1, as described above.
Johnson further discloses wherein the sleeve plug secures the distal end of the elongated flexible tubular sleeve to the distal end of the hollow tube through an interference fit (Johnson FIG. 1; Johnson col. 7 lines 63-65, “the guide tube 14 is in its fully retracted condition such that the balloon distal end connection 30 is immediately adjacent the proximal end connection 26”).
Regarding Claim 10, Johnson in view of Rahamimov teach the features of Claim 1, as described above.
Johnson further discloses a handle (Johnson Fig. 1, unlabeled handle at proximal end of guide tube 14, connected to proximal end of balloon 26), wherein the handle is configured to be mounted over the proximal end of the elongated flexible tubular sleeve for pulling the elongated flexible tubular sleeve distally.
Regarding Claim 11, Johnson discloses:
A method for inverting an elongated, flexible tubular sleeve (Johnson FIG. 1, balloon 26) having a proximal end, a distal end and a central lumen extending between the proximal end and the distal end, the method comprising providing an apparatus comprising:
a hollow tube (Johnson FIG. 1, tube 15) comprising a proximal end, a distal end and a central lumen extending between the proximal end and the distal end; and
an elongated rod (Johnson FIG. 1, guide tube 14) movably disposed within the central lumen of the hollow tube, the elongated rod having a proximal end and a distal end, wherein the distal end of the elongated rod comprises a sleeve plug (Johnson FIG. 1, connection 30) for securing a distal end of an elongated flexible tubular sleeve (Johnson FIG. 1, balloon 26) to the distal end of the hollow tube (Johnson FIG. 1, showing connection 30 pressing distal end of balloon 26 against distal end of tube 15);
disposing the elongated flexible tubular sleeve over the hollow tube (Johnson FIG. 2, showing sleeve 26 disposed over at least a portion of tube 15);
moving the elongated rod proximally, whereby to clamp the distal end of the elongated flexible tubular sleeve to the distal end of the hollow tube (Johnson FIG. 1, showing connection 30 pressing distal end of balloon 26 against distal end of tube 15).
Johnson does not explicitly disclose pulling the proximal end of the elongated flexible tubular sleeve distally toward the distal end of the elongated flexible tubular sleeve, whereby to invert the elongated flexible tubular sleeve.
Rahamimov teaches pulling the proximal end of the elongated flexible tubular sleeve distally toward the distal end of the elongated flexible tubular sleeve, whereby to invert the elongated flexible tubular sleeve (Rahamimov FIG. 3A, showing distal end of sheath 30 connected to distal end of tube 20 and sheath 30 being inverting while distal end of tube 20 moves towards proximal end of sheath 30).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to substitute Rahamimov’s sheath orientation for Johnson’s balloon. A person having ordinary skill in the art would be motivated to make this substitution in order to allow the inverted sheath/sleeve to be lubricated (see paragraphs [0077] – [0078] of Rahamimov).
Regarding Claim 17, Johnson in view of Rahamimov teach the features of Claim 11, as described above.
Johnson further discloses wherein the sleeve plug secures the distal end of the elongated flexible tubular sleeve to the distal end of the hollow tube through an interference fit (Johnson FIG. 1; Johnson col. 7 lines 63-65, “the guide tube 14 is in its fully retracted condition such that the balloon distal end connection 30 is immediately adjacent the proximal end connection 26”).
Regarding Claim 24, Johnson in view of Rahamimov teach the features of Claim 11, as described above.
Johnson further discloses moving the elongated rod distally to release the distal end of the elongated flexible tubular sleeve from the hollow tube (Johnson FIG. 2, showing distal end of balloon 26 released from tube 14).
Claims 2 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Johnson et al. (US Patent 6,039,721 – “Johnson”) in view of Rahamimov (US PGPUB 2007/0123798 – “Rahamimov”) and Ortiz (US PGPUB 2007/0106302 – “Ortiz”).
Regarding Claim 2, Johnson in view of Rahamimov teach the features of Claim 1, as described above.
Johnson in view of Rahamimov do not explicitly teach a lever for selectively moving the elongated rod distally or proximally relative to the distal end of the hollow tube, wherein the lever is mounted to the proximal end of the elongated rod.
Ortiz teaches a lever (Ortiz FIG. 5, lever arms 70a/70b) for selectively moving the elongated rod distally or proximally relative to the distal end of the hollow tube, wherein the lever is mounted to the proximal end of the elongated rod (Ortiz paragraph [0045], “FIG. 5 illustrates an alternative embodiment of device 10' that includes control elements 20a', 20b' connected to tubing elements 18a', 18b'. Each control element 20a', 20b' includes first and second lever arms 70a, 70b, 71a, 71b. Moving the lever arms together or apart controls rods 40 and thus tubing elements 18a', 18b'.”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Ortiz’s levers with Johnson’s elongated rod. A person having ordinary skill in the art would be motivated to make this combination in order to control axial control of the elongated rod.
Regarding Claim 12, Johnson in view of Rahamimov teach the features of Claim 11, as described above.
Johnson in view of Rahamimov do not explicitly teach a lever for selectively moving the elongated rod distally or proximally relative to the distal end of the hollow tube, wherein the lever is mounted to the proximal end of the elongated rod.
Ortiz teaches a lever (Ortiz FIG. 5, lever arms 70a/70b) for selectively moving the elongated rod distally or proximally relative to the distal end of the hollow tube, wherein the lever is mounted to the proximal end of the elongated rod (Ortiz paragraph [0045], “FIG. 5 illustrates an alternative embodiment of device 10' that includes control elements 20a', 20b' connected to tubing elements 18a', 18b'. Each control element 20a', 20b' includes first and second lever arms 70a, 70b, 71a, 71b. Moving the lever arms together or apart controls rods 40 and thus tubing elements 18a', 18b'.”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Ortiz’s levers with Johnson’s elongated rod. A person having ordinary skill in the art would be motivated to make this combination in order to control axial control of the elongated rod.
Claims 8-9 and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Johnson et al. (US Patent 6,039,721 – “Johnson”) in view of Rahamimov (US PGPUB 2007/0123798 – “Rahamimov”) and Lichtenstein (US PGPUB 2017/0265724 – “Lichtenstein”).
Regarding Claim 8, Johnson in view of Rahamimov teach the features of Claim 1, as described above.
Johnson in view of Rahamimov do not explicitly teach wherein the sleeve plug comprises an expandable plug and a holding collar, the expandable plug being mounted to the distal end of the elongated rod.
Lichtenstein teaches wherein the sleeve plug comprises an expandable plug and a holding collar (Lichtenstein inflatable head 49 at distal end of push-pull rod 46), the expandable plug being mounted to the distal end of the elongated rod.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to substitute Lichtenstein’s head for Johnson’s connection. A person having ordinary skill in the art would be motivated to make this substitution in order to releasably connect a rod to a sleeve (Lichtenstein paragraph [0068], “inflatable head 49 that help facilitate the pushing and pulling of sleeve 30 inside sheath 20. Pushing and pulling of push-pull rod 45 or 46 can be synchronized with the inflation and deflation of inflatable head 48”).
Regarding Claim 9, Johnson in view of Rahamimov and Lichtenstein teach the features of Claim 8, as described above.
Lichtenstein further teaches wherein the expandable plug comprises a first portion (Lichtenstein FIG. 9, inflation tube within inflatable head 49) and a second portion (Lichtenstein FIG. 9, exterior portion of inflatable head 49), wherein the second portion is configured to be moved into the first portion to expand the outer diameter of the expandable plug.
Regarding Claim 18, Johnson in view of Rahamimov teach the features of Claim 11, as described above.
Johnson in view of Rahamimov do not explicitly teach wherein the sleeve plug comprises an expandable plug and a holding collar, the expandable plug being mounted to the distal end of the elongated rod, and further wherein the method further comprises:
positioning the expansion plug within the distal end of the elongated flexible tubular sleeve;
positioning the holding collar over the distal end of the elongated flexible tubular sleeve and the expandable plug; and
expanding the expandable plug to secure the distal end of the elongated flexible tubular sleeve to the distal end of the hollow tube.
Lichtenstein teaches wherein the sleeve plug comprises an expandable plug and a holding collar (Lichtenstein FIG. 9, inflatable head 49 at distal end of push-pull rod 46), the expandable plug being mounted to the distal end of the elongated rod, and further wherein the method further comprises:
positioning the expansion plug within the distal end of the elongated flexible tubular sleeve (Lichtenstein FIG. 1, sleeve 30 within sheath 20; Lichtenstein paragraph [0068], “push-pull rod 46 includes inflatable head 49 that help facilitate the pushing and pulling of sleeve 30 inside sheath 20”);
positioning the holding collar over the distal end of the elongated flexible tubular sleeve and the expandable plug (Lichtenstein FIG. 9, exterior of inflatable head 49 at distal end of push-pull rod 46); and
expanding the expandable plug to secure the distal end of the elongated flexible tubular sleeve to the distal end of the hollow tube (Lichtenstein paragraph [0068], “inflatable head 49 that help facilitate the pushing and pulling of sleeve 30 inside sheath 20. Pushing and pulling of push-pull rod 45 or 46 can be synchronized with the inflation and deflation of inflatable head 48”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to substitute Lichtenstein’s head for Johnson’s connection. A person having ordinary skill in the art would be motivated to make this substitution in order to releasably connect a rod to a sleeve (Lichtenstein paragraph [0068], “inflatable head 49 that help facilitate the pushing and pulling of sleeve 30 inside sheath 20. Pushing and pulling of push-pull rod 45 or 46 can be synchronized with the inflation and deflation of inflatable head 48”).
Regarding Claim 19, Johnson in view of Rahamimov and Lichtenstein teach the features of Claim 18, as described above.
Lichtenstein further teaches wherein the expandable plug comprises a first portion (Lichtenstein FIG. 9, inflation tube within inflatable head 49) and a second portion (Lichtenstein FIG. 9, exterior portion of inflatable head 49), wherein the second portion is configured to be moved into the first portion to expand the outer diameter of the expandable plug.
Claims 25 and 27-29 are rejected under 35 U.S.C. 103 as being unpatentable over Allen IV (US PGPUB 2020/0297988 – “Allen”) in view of Kim et al. (US PGPUB 2020/0139084 – “Kim”).
Regarding Claim 25, Allen discloses:
a sleeve (Allen FIG. 3, sleeve 14) adapted to be slid over the exterior of an endoscope (Allen FIG. 3, endoscope 28), wherein the sleeve comprises a sleeve proximal end, a sleeve distal end and a sleeve lumen extending therebetween, and further wherein the sleeve is configured to be slid over the exterior surface of the endoscope so as that the interior surface of the sleeve lumen substantially covers the exterior surface of the endoscope from a point adjacent to the distal end of the endoscope to a point adjacent to the handle of the endoscope (Allen paragraph [0049], “endoscope 28 is positioned within the sleeve 14”); and
at least one support channel (Allen FIG. 3, cavity 80) carried by the sleeve, wherein the at least one support channel comprises a channel proximal end, a channel distal end and a channel lumen extending therebetween (Allen paragraph [0062], “the fluid pressure moves into the cavity 80 in the distal inverted portion 30 of the sleeve 14 in the direction indicated by the arrow “B”. When the pressurized fluid enters the cavity 80 in the distal inverted portion 30 of the sleeve 14, the sleeve 14 is forced distally within the lumen “L” of the body vessel “By” and unfurls from about the toroid 62 (or is pulled through the central opening 46 of the housing 12) such that the distal portion 30 of the sleeve 14 extends into the lumen “L” defined by the body cavity “BC” in a substantially linear direction.”).
Allen does not explicitly disclose wherein the interior surface of the sleeve lumen comprises a hydrophilic coating.
Kim teaches wherein the interior surface of the sleeve lumen comprises a hydrophilic coating (Kim FIG. 3A, sleeve 102; Kim paragraph [0064], “a lubricious (e.g., hydrophilic) or other type of coating may be applied over portions or all of the polymer sleeve 102”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Kim’s hydrophilic coating with Allen’s sleeve/sheath that forms Allen’s sleeve lumen. A person having ordinary skill in the art would be motivated to make this combination since “Lubricious coatings improve steerability within a body lumen or passage, and improve lesion crossing capability therein” (see paragraph [0064] of Kim.
Regarding Claim 27, Allen in view of Kim teach the features of Claim 25, as described above.
Allen further discloses wherein the sleeve is flexible (Allen paragraph [0063], The flexibility of the sleeve 14 allows the sleeve 14 to follow the path defined by the body vessel “By” as the sleeve 12 translates through the lumen “L” of the body vessel “By”.”).
Regarding Claim 28, Allen in view of Kim teach the features of Claim 25, as described above.
Allen further discloses wherein the at least one support channel is disposed external to the sleeve lumen (Allen FIG. 3, showing support channel/cavity 80 disposed external to the interior lumen of sleeve 14).
Regarding Claim 29, Allen in view of Kim teach the features of Claim 25, as described above.
Allen further discloses wherein the channel proximal end is disposed adjacent to the sleeve proximal end (Allen FIG. 3, showing proximal end of cavity 80 adjacent to proximal end of sleeve 14), and wherein the channel distal end is disposed adjacent to the sleeve distal end (Allen FIG. 3, showing distal end of cavity 80 adjacent to distal end of sleeve 14).
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Allen IV (US PGPUB 2020/0297988 – “Allen”) in view of Kim et al. (US PGPUB 2020/0139084 – “Kim”) and Tsai et al. (US PGPUB 2014/0236120 – “Tsai”).
Regarding Claim 26, Allen in view of Kim teach the features of Claim 25, as described above.
Allen further discloses:
inverting the sleeve (Allen FIG. 3, showing inverted sleeve 14);
reverting the sleeve (Allen paragraph [0064], “the sleeve 14 can be retracted about the toroid 62 to withdraw the endoscope 28 from the lumen of the body vessel “By”.”).
Allen in view of Kim do not explicitly teach wherein the hydrophilic coating is applied to the interior surface of the sleeve lumen by:
applying the hydrophilic coating to the inverted interior surface of the sleeve lumen; allowing the hydrophilic coating to cure.
Tsai teaches wherein the hydrophilic coating is applied to the interior surface of the sleeve lumen by:
applying the hydrophilic coating to the inverted interior surface of the sleeve lumen (Tsai FIG. 22B coatings 23 and catheter layers 20, 22; Tsai paragraph [0062] – [0063], “The lubricating coatings 23 will be applied to the outer surface of the inner catheter, the outer surface of the outer catheter, and/or the inner surface of the outer catheter…the coatings 23 may be made of the from a variety of materials include…a hydrophilic synthetic polymer network that is applied by dip or brush coating”).
allowing the hydrophilic coating to cure (Tsai paragraph [0063], “coatings 23 may be…cured to the catheter surface by UV treatment”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Tsai’s hydrophilic/lubricious coating to Allen’s sleeve. A person having ordinary skill in the art would be motivated to make this combination in order to allow ease of movement of the sleeve through a patient’s lumen by reducing friction between various components (see paragraph [0062] of Tsai”).
Claim 37 is rejected under 35 U.S.C. 103 as being unpatentable over Allen IV (US PGPUB 2020/0297988 – “Allen”) in view of Tsai et al. (US PGPUB 2014/0236120 – “Tsai”).
Regarding Claim 37, Allen discloses:
A method for applying a hydrophilic coating to a sleeve (Allen FIG. 3, sleeve 14) adapted to be slid over the exterior of an endoscope (Allen FIG. 3, endoscope 28), wherein the sleeve comprises:
a sleeve proximal end, a sleeve distal end and a sleeve lumen extending therebetween, and further wherein the sleeve is configured to be slid over the exterior of the endoscope so as that the interior surface of the sleeve lumen substantially covers the exterior of the endoscope from a point adjacent to the distal end of the endoscope to a point adjacent to the handle of the endoscope (Allen paragraph [0049], “endoscope 28 is positioned within the sleeve 14”); and
at least one support channel (Allen FIG. 3, cavity 80) carried by the sleeve, wherein the at least one support channel comprises a channel proximal end, a channel distal end and a channel lumen extending therebetween (Allen paragraph [0062], “the fluid pressure moves into the cavity 80 in the distal inverted portion 30 of the sleeve 14 in the direction indicated by the arrow “B”. When the pressurized fluid enters the cavity 80 in the distal inverted portion 30 of the sleeve 14, the sleeve 14 is forced distally within the lumen “L” of the body vessel “By” and unfurls from about the toroid 62 (or is pulled through the central opening 46 of the housing 12) such that the distal portion 30 of the sleeve 14 extends into the lumen “L” defined by the body cavity “BC” in a substantially linear direction.”);
inverting the sleeve (Allen FIG. 3, showing inverted sleeve 14);
reverting the sleeve (Allen paragraph [0064], “the sleeve 14 can be retracted about the toroid 62 to withdraw the endoscope 28 from the lumen of the body vessel “By”.”).
Allen does not explicitly disclose:
applying the hydrophilic coating to the inverted interior surface of the sleeve lumen;
allowing the hydrophilic coating to cure.
Tsai teaches:
applying the hydrophilic coating to the inverted interior surface of the sleeve lumen (Tsai FIG. 22B coatings 23 and catheter layers 20, 22; Tsai paragraph [0062] – [0063], “The lubricating coatings 23 will be applied to the outer surface of the inner catheter, the outer surface of the outer catheter, and/or the inner surface of the outer catheter…the coatings 23 may be made of the from a variety of materials include…a hydrophilic synthetic polymer network that is applied by dip or brush coating”);
allowing the hydrophilic coating to cure (Tsai paragraph [0063], “coatings 23 may be…cured to the catheter surface by UV treatment”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Tsai’s hydrophilic/lubricious coating to Allen’s sleeve. A person having ordinary skill in the art would be motivated to make this combination in order to allow ease of movement of the sleeve through a patient’s lumen by reducing friction between various components (see paragraph [0062] of Tsai”).
Conclusion
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JIM BOICE
Examiner
Art Unit 3795
/JAMES EDWARD BOICE/Examiner, Art Unit 3795
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795 01/31/26