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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/27/2026 has been entered.
Response to Amendment
Claims 1-8, 13-14 are pending. Claims 9 -12 are cancelled. Claims 15-20 are withdrawn.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-8, 13-14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “the elongate body defining a lumen extending between the proximal and distal end portions, the lumen being sized and shaped to receive the insertion tube of the endoscope, and wherein the elongate body comprises an inflatable balloon at the distal end portion and a first fluid inlet and a second fluid inlet, the first and second fluid inlets disposed on opposite sides of the elongate body at the distal end portion between the distal end portion and the inflatable balloon, wherein the first and second fluid inlets are in fluid communication with the lumen.”
The first and second fluid inlets being at the distal end portion. It is unclear how they (the first and second fluid inlets) are between the distal end portion and the inflatable balloon.
Appropriate correction is required.
Claims 2-8, 13-14 are rejected for being dependent on a rejected base claim.
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, 4-6, 8-14, is/are rejected under 35 U.S.C. 103 as being unpatentable over Condon (US 5188596) and in view of Sanchez (US 20150065995).
Regarding claim 1, Condon discloses urinary catheter system (a prostate dilation balloon disposed on a urethral catheter; FIG. 1) comprising:
an endoscope (FIG. 52) having an insertion tube sized and shaped to be inserted into a body lumen of a patient; and
a urinary catheter (catheter 50) including an elongate body 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 extending between the proximal and distal end portions, the lumen being sized and shaped to receive the insertion tube of the endoscope (FIG. 6, annotated), and wherein the elongate body comprises an inflatable balloon (dilation balloon 55) at the distal end portion.
Condon does not expressly disclose a first fluid inlet and a second fluid inlet, the first and second fluid inlets disposed on opposite sides of the elongate body at the distal end portion between the distal end portion and the inflatable balloon, wherein the first and second fluid inlets are in fluid communication with the lumen.
Sanchez is directed to intraluminal occluding catheter (abstract) and teaches a first fluid inlet (Orifices 60) and a second fluid inlet (Orifices 60; FIG. 9A), the first and second fluid inlets disposed on opposite sides of the elongate body (Orifices 60 are opposite to each other) at the distal end portion (FIG. 9A) between the distal end portion and the inflatable balloon (Also, note the 112(b) rejection above), wherein the first and second fluid inlets are in fluid communication with the lumen (FIG. 10 shows channels 30 that allow for fluidic communication with the orifices 60. Para [0051]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Condon to include orifices in the distal portion of the catheter in accordance with the teaching of Sanchez so that accumulated gas or liquid could be removed from the physiologic lumen (Para [0056]) via the channels. Further, inlets could be made in opposite sides of the channels/lumen so that they can drain the fluid from both sides.
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Regarding claim 2, Condon discloses wherein the lumen has a lumen diameter that is larger than an insertion tube diameter of the insertion tube of the endoscope (FIGS. 1, 6).
Regarding claim 4, Condon discloses 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 (FIGS. 1, 6).
Regarding claim 5, Condon discloses wherein the elongate body includes a tip at the distal end portion, the tip defining a closed distal end of the lumen (Catheter 22 is transparent and closed at the distal end; FIG. 1 annotated).
Regarding claim 6, Condon discloses 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. Col. 5, line 47-col. 6, line 5).
Regarding claim 7, Condon discloses wherein the tip comprises a first material (material of the balloon; 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 8, 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).
Regarding claim 13, Condon discloses 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 (FIG. 1).
Regarding claim 14, Condon discloses 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 (Distal end of the scope 20 is a video camera; Col. 5, lines 1 -27) 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 Condon (US 5188596) and in view of Sanchez (US 20150065995) further in view of Cooper (US 20180110456).
Regarding claim 3, Condon 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 Condon 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 1/27/2026 have been fully considered and are persuasive. Therefore, the rejection dated 12/02/2025 have been withdrawn. However, upon further consideration, a new rejection has been made in view of amendment. See rejection set forth above.
Conclusion
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
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795 03/23/26