DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
In response to the amendment filed on 06/16/2026, Claims 1-38 have been cancelled, and Claims 39 and newly added Claim 40-55 are pending.
Election/Restrictions
Applicant’s election WITHOUT traverse of GROUP I in the reply filed on 06/16/2026 is acknowledged. Claims 40 has been withdrawn from further consideration and claims 39 and 41-55 are pending.
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.
Claim(s) 39, 41, 42, and 52 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Terliuc (US PGPub 2009/0227835).
Regarding Claim 39, Terliuc teaches an apparatus comprising:
a sleeve (104; Figure 2) adapted to be slid over the exterior of an endoscope (101; Paragraph 0053), said sleeve (104) comprising a passageway (109; Figure 2; Paragraph 0064) formed integral with said sleeve (the lumen is the lumen for the endoscope in Figures 2 and 4A; Paragraph 0054) and a lumen formed integral with said sleeve for receiving an instrument (the lumen is the lumen for the endoscope in Figures 2 and 4A; Paragraph 0054) ;
a proximal balloon (103; Figure 2 and 4A; Paragraph 0053) secured to said sleeve (104; Figure 2 and 4A);
an inflation/deflation tube (106; Figure 2) carried by said sleeve (104) and in fluid communication with the interior of said proximal balloon (103; Figures 2-4A; Paragraph 0056);
a push tube (112; Paragraph 0065; Figure 2) slidably mounted in said passageway (109) of said sleeve (Figure 2; Paragraph 0076-0077); and
a distal balloon (116; Figure 2; Paragraph 0065) secured to the distal end of said push tube (112; Paragraph 0067), the interior of said distal balloon (116) being in fluid communication with said push tube (112; Paragraph 0065).
Regarding Claim 41, Terliuc teaches the apparatus according to claim 39 wherein the sleeve (104) comprises at least one push tube support tube (108; Figure 2; Paragraph 0062-0064), the at least one push tube support tube (108) being configured to slidably receive the push tube (112) therein (Paragraph 0065).
Regarding Claim 42, Terliuc teaches the apparatus according to claim 39 wherein the sleeve comprises (104) one selected from the group consisting of polyurethane, polyethylene, poly(vinyl chloride) (PVC) and polytetrafluoroethylene (PTFE) (Paragraph 0055).
Regarding Claim 52, Terliuc teaches the apparatus according to claim 39 wherein at least one of the distal balloon (116; Figure 2) and the proximal balloon (104; Figure 2) comprises polyurethane (Paragraphs 0061 and 0075).
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) 43 is/are rejected under 35 U.S.C. 103 as being unpatentable over Terliuc (US PGPub 2009/0227835) as applied to claim 39 above, and further in view of Kress (US PGPub 2006/0053662).
Regarding Claim 43, Terliuc teaches the apparatus according to claim 39 but fails to disclose wherein the sleeve (104) is configured to be secured to the exterior of an endoscope by pulling a vacuum between the sleeve and the endoscope.
Kress teaches an endoscope device comprising a sleeve (3; Figure 1) which is meant to be placed over endoscope (2; Figure 1; Paragraph 0044), wherein the sleeve (104) is configured to be secured to the exterior of an endoscope (2) by pulling a vacuum between the sleeve (2) and the endoscope (3; Paragraph 0041 but see also Paragraph 0013 and 0022).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the sleeve of Terliuc, to be selectively attached to the endoscope by a vacuum, as taught by Kress, for the advantage of being able to lock together and release apart the sleeve and endoscope to manipulate a relative position between the two from outside the body.
Claim(s) 44-49 is/are rejected under 35 U.S.C. 103 as being unpatentable over Terliuc (US PGPub 2009/0227835) as applied to claim 39 above, and further in view of Sepetka (US PGPub 2002/0177870)
Regarding Claim 44, Terliuc teaches the apparatus according to claim 39 but fails to explicitly teach wherein the push tube comprises one selected from the group consisting of a thermoplastic polyethylene resin, polyethylene, polypropylene, nylon, Nitinol and a stainless steel coil covered with an outer jacket of polytetrafluoroethylene (PTFE).
Sepetka teaches a balloon catheter (100) comprising a balloon (108) and a catheter body (Figure 1; Paragraph 0025; the balloon and catheter body of Sepetka is equivalent to the distal balloon and push tube of Terliuc, respectively), wherein the push tube (102) comprises one selected from the group consisting of a thermoplastic polyethylene resin, polyethylene, polypropylene, nylon, Nitinol and a stainless steel coil covered with an outer jacket of polytetrafluoroethylene (PTFE) (Paragraph 0029-0031).
Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the material of the push tube of Terliuc using the materials as taught by Sepetka, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960). (See MPEP 2144.07)
Regarding Claim 45, Terliuc teaches the apparatus according to claim 39 but fails to disclose wherein the push tube comprises a plurality of materials, and further wherein at least one of the plurality of materials comprises different mechanical properties than the others of the plurality of materials.
Sepetka teaches a balloon catheter (100) comprising a balloon (108) and a catheter body (Figure 1; Paragraph 0025; the balloon and catheter body of Sepetka is equivalent to the distal balloon and push tube of Terliuc, respectively), wherein the push tube (102) comprises a plurality of materials, and further wherein at least one of the plurality of materials comprises different mechanical properties than the others of the plurality of materials (Paragraph 0028-0036)
Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the material of the push tube of Terliuc using the materials as taught by Sepetka, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960). (See MPEP 2144.07) Furthemore, it would have been obvious to modify the catheter to have different materials having different mechanical properties for the advantage of having a more stiff proximal section and a more flexible distal section for improving anti-kink pushability without sacrificing flexibility of the distal tip)
Regarding Claim 46, the combination of references disclosed above teaches the apparatus according to claim 45 wherein Sepetka teaches the push tube (102) comprises a distal portion and a proximal portion, and wherein the distal portion of the push tube is more flexible than the proximal portion of the push tube (Paragraph 0028 and Paragraph 0036)
Regarding Claim 47, the combination of references disclosed above teaches the apparatus according to claim 46 wherein the distal portion (134; Paragraph 0028; Figure 2) comprises one from the group consisting of Nitinol and a stainless steel coil covered with an outer jacket of polytetrafluoroethylene (PTFE) (Paragraph 0031 and 0033).
Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the material of the push tube of Terliuc using the materials as taught by Sepetka, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960). (See MPEP 2144.07)
Regarding Claim 48, Terliuc teaches the apparatus according to claim 39 but fails to disclose wherein the push tube comprises distance markers.
Sepetka teaches a balloon catheter (100) comprising a balloon (108) and a catheter body (Figure 1; Paragraph 0025; the balloon and catheter body of Sepetka is equivalent to the distal balloon and push tube of Terliuc, respectively), wherein the push tube (102; Figure 2) comprises distance markers (156 and 158; Paragraph 0037; it’s the examiner’s position that the markers are at a fixed distance from the distal tip and thus are configured to be distance markers).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of Terliuc to include distance markers, as taught by Sepetka for the advantage of determining the position of the balloon while within the patient.
Regarding Claim 49, the combination of references disclosed above teaches the apparatus according to claim 48 wherein Sepetka teaches the distance markers comprise one selected from the group consisting of colored indicators and radiopaque indicators (Paragraph 0037; Sepetka).
Claim(s) 53-54 is/are rejected under 35 U.S.C. 103 as being unpatentable over Terliuc (US PGPub 2009/0227835) as applied to claim 39 above, and further in view of van Sloten (US PGPub 2006/0224114)
Regarding Claim 53-54, Terliuc teaches the apparatus according to claim 39 but fails to disclose wherein the distal balloon comprises an indicator for facilitating observation of the balloon at a surgical site (Claim 53) and wherein the indicator comprises one selected from the group consisting of a color indicator and a radiopaque indicator (Claim 54).
Van Sloten teaches a balloon catheter for use with an endoscope (abstract), and thus is equivalent to the distal balloon of Terliuc, wherein the balloon comprises an indicator (44, 46, 48; Figure 1; Paragraph 0035) for facilitating observation of the balloon at a surgical site (Claim 53) and wherein the indicator (44, 46, 48) comprises one selected from the group consisting of a color indicator and a radiopaque indicator (Claim 54; Paragraph 0037-0040).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the distal balloon taught by Terliuc, to include the marker teachings of van Sloten, for the advantage that “Such markers may enable a physician to use the view through an endoscope to accurately position the balloon at the desired site for treatment, for example centered within a lesion or stricture.” (Paragraph 0015; van Sloten).
Claim(s) 55 is/are rejected under 35 U.S.C. 103 as being unpatentable over Terliuc (US PGPub 2009/0227835) as applied to claim 39 above, and further in view of Smith (US PGPub 2017/0105726). It appears this claim has an effective filing date of 08/20/2019.
Regarding Claim 55, Terluic teaches the apparatus according to claim 39 but fails to disclose wherein the distal balloon comprises a clip, and further wherein the clip is configured to enhance traction between the clip and anatomy engaged by the clip.
Smith teaches retraction devices for attaching to tissue comprising an expandable stabilizing anchor (670; Figure 6; Paragraph 0053 0054), wherein the stabilizing anchor (670) can be anchored to the body wall by a clip (Paragraph 0055; Smith).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the distal balloon of Terliuc, to include a clip, as taught by Smith, for the advantage of increasing the connection strength between the balloon and attached tissue during manipulation of the balloon to manipulate the tissue.
Allowable Subject Matter
Claims 50-51 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Regarding Claim 50, the prior art of record fails to disclose the apparatus according to claim 39 wherein the distal balloon is capable of assuming a deflated condition and an inflated condition, and further wherein (i) when the distal balloon is in the deflated condition, an axial opening extends therethrough, the axial opening being sized to receive the endoscope therein, and (ii) when the distal balloon is in the inflated condition, the axial opening is closed down.
Regarding Claim 51, the prior art of record fails to disclose teaches the apparatus according to claim 50 wherein when the distal balloon is in the inflated condition, no fluid can pass through the axial opening.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOHAMED GAMIL GABR whose telephone number is (571)272-0569. The examiner can normally be reached M-F 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at (571) 270-5953. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MOHAMED G GABR/Primary Examiner, Art Unit 3771
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