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
Claims 1-4, 6-8, 13-14 are pending. Claims 5, 9 -12 are cancelled. Claims 15-20 are withdrawn. Applicant’s amendment to the claims have overcome 112 (b) rejections previously set forth in the Non-Final Office Action notified on 03/25/2026.
Claim Rejections - 35 USC § 103
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 factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-2, 4, 7, 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Azar (US 20140100553) in view of Vazales (US 20140150782).
Regarding claim 1, Azar discloses a urinary catheter system (FIGS. 1A-1C) comprising:
a urinary catheter (FIGS. 1A-1C) including an elongate body ( body of the atraumatic urinary catheter; para [0063]-[0064]) having an axis and proximal and distal end portions spaced apart from one another along the axis, the elongate body being sized and shaped to be received in the body lumen, the elongate body defining a lumen (Channel 106 connected to the bladder cavity by hole 108; para [0065]) extending between the proximal and distal end portions, the lumen being sized and shaped to receive an insertion tube of an endoscope (Note that an endoscope can be received in the channel), wherein the elongate body includes a tip at the distal end portion, the tip defining a closed distal end of the lumen (Tip of the catheter, FIG. 2A is closed), and wherein the elongate body comprises an inflatable balloon (balloon 107) at the distal end portion and a first fluid inlet (hole 108; FIG. 2A), disposed on elongate body at the tip of the distal end portion between the distal end portion and the inflatable balloon (FIG. 2A).
Azar does not expressly disclose an endoscope having an insertion tube sized and shaped to be inserted into a body lumen of a patient; and a second fluid inlet, wherein the first and second fluid inlets are in fluid communication with the lumen.
Vazales is directed to a suction system module (abstract) an endoscope (scope 103; FIG. 2A; para [0145]) having an insertion tube sized and shaped to be inserted into a body lumen of a patient and and a second fluid inlet (suction eyes 1530; FIG. 17B; Para [0240]), wherein the first and second fluid inlets are in fluid communication with the lumen (irrigation line 1525; suction eyes 1530 are opposite to each other; FIG. 17B; Para [0240]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify Azar to include an endoscope to use with the catheter of Azar so that the endoscope could be used for imaging or draining liquid during surgery.
Further, another drain hole could be provided in the catheter (of Azar) opposite to the opening 108 in accordance with the teaching of Vazales (opposite suction eyes 1530; FIG. 17B) so that the liquid could be drained from both sides of the catheter for faster draining of the fluid during surgery.
Regarding claim 2, Azar as modified teaches wherein the lumen has a lumen diameter that is larger than an insertion tube diameter of the insertion tube of the endoscope (Azar : Channel 106; For visualization inside the catheter, the diameter of the catheter needs be provided larger. And it is obvious that one of ordinary skill in the would have made the diameter of the channel 106 larger for receiving the scope 103 for visualization. This results from an intended use of an endoscope with a catheter when using together as a system.) .
Regarding claim 4, Azar as modified teaches wherein the lumen has an open proximal end at the proximal end portion, the open proximal end sized and shaped to receive the insertion tube of the endoscope (Azar: Channel 106; For visualization inside the catheter, the diameter of the catheter needs be provided larger. And it is obvious that one of ordinary skill in the would have made the diameter of the channel 106 larger for receiving the scope 103 for visualization. This results from an intended use of an endoscope along with a catheter when using it together as a system.).
Regarding claim 7, Azar as modified teaches wherein the tip comprises a first material (material of the balloon 107; FIG. 1) and a remainder of the elongate body comprises one or more additional materials that are different from the first material (Material of the catheter elongate body which is not the balloon material is different from the balloon material.).
Regarding claim 13, Azar as modified teaches wherein the insertion tube of the endoscope is disposed in the lumen of the catheter such that as manufactured, the catheter is mounted on the endoscope (Azar: FIG. 2A; Vazales: FIG. 12A).
Claim(s) 6, 8, 14, is/are rejected under 35 U.S.C. 103 as being unpatentable over Azar (US 20140100553) in view of Vazales (US 20140150782) and further in view of Condon (US 5188596).
Regarding claim 6, Azar does not expressly disclose wherein the tip is transparent
Condon is directed to prostate dilation balloon (abstract) and teaches wherein the tip is transparent (the catheter 22 is made of a transparent material so that the scope 20 can view outside thereof to observe the location of the dilation balloon and fixation balloon relative to the various structures of the urological system.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify Azar to include a transparent tip so that endoscope could be used to visualize outside of the catheter.
Regarding claim 8, Azar does not expressly disclose wherein the elongate body is transparent.
Condon discloses wherein the elongate body is transparent (The catheter 22 is made of a transparent material so that the scope 20 can view outside thereof to observe the location of the dilation balloon and fixation balloon relative to the various structures of the urological system. Col. 5, line 47-col. 6, line 5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify Azar to include a transparent tip so that endoscope could be used to visualize outside of the catheter.
Regarding claim 14, Azar as modified discloses teaches wherein the elongate body includes a transparent tip at the distal end portion (The catheter 22 is made of a transparent material so that the scope 20 can view outside thereof to observe the location of the dilation balloon and fixation balloon relative to the various structures of the urological system. FIG.1; Col. 5, line 47-col. 6, line 5), and wherein the endoscope includes a camera (Vazales: scope 103) arranged to look through the transparent tip of the elongate body.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Azar (US 20140100553) in view of Vazales (US 20140150782) further in view of Cooper (US 20180110456).
Regarding claim 3, Azar does not expressly disclose wherein the lumen diameter is about 5.4 mm.
Cooper is directed to methods and devices for monitoring bladder health (abstract) and teaches wherein the lumen diameter is about 5.4 mm (16 French (“Fr”) 16-inch male catheter, para [0070], indicates 5.3 mm diameter of the catheter.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify Azar to include the diameter of catheter in accordance with the teaching of Cooper so that the catheter could be passed through a small size veins and lumens in the body.
Response to Arguments
Applicant’s arguments submitted on 7/24/2026 have been fully considered and are persuasive. Therefore, the rejection dated 3/25/2026 has been withdrawn. However, upon further consideration, a new rejection has been made in view of amendment. See rejection set forth above.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHANKAR R GHIMIRE whose telephone number is (571)272-0515. The examiner can normally be reached 8 AM - 5 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anhtuan Nguyen can be reached at 571-272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHANKAR RAJ GHIMIRE/Examiner, Art Unit 3795
/ANHTUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
9/16/26
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