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 .
Election/Restrictions
Applicant’s election without traverse of Species AA: Figures 2-5 and 8-9 in the reply filed on 8/4/2025 is acknowledged.
Nonelected claims 4, 12-13, and 15-16 were cancelled by applicant in the reply filed 8/4/2025.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 claim requires “the drain opening” on line 8. However, line 4 of the claim has been amended to require “a plurality of drain openings.” For examination purposes, line 8 has been interpreted to recite “to allow liquid entering the plurality of drain openings…”.
Claim 1, Line 13 ends with both a comma and a semicolon.
Appropriate correction is required.
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.
Claim 9 is 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 9 recites the limitation "the tip protrusion of the protective tube" in line 3. There is insufficient antecedent basis for this limitation in the claim.
The examiner notes that a tip protrusion of the protective tube is introduced in claim 8 (which is dependent from claim 1). The examiner recommends amending claim 8 to depend from Claim 6, and amending claim 9 to depend from claim 9. For examination purposes, the claim has been interpreted accordingly.
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.
Claims 1-3, 5, and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Paulen et al. (US 2010/0324540) in view of Carleo (US 2012/0179144).
With respect to Claim 1, Paulen teaches a urinary catheter assembly (Figures 1-4A) comprising:
a urinary catheter 12 (Figure 1; the portion of catheter 12 that extends from the handle 10) comprising a catheter tube with a proximal insertion end extending from the proximal insertion end toward a distal outlet end (Figure 1 and see the annotated figure below), the catheter comprising a lubricious coating (lubricating antiseptic gel is disposed between protective tube 11 and catheter 12; paragraph [0046]);
a handle 10 coupled with the distal outlet end of the catheter tube 12, the handle comprising a first cavity and a second cavity (see the annotated figure below), the first cavity forming a through-going hole to allow liquid in the patient’s bladder to drained and exit a distal end of the handle (the through-going hole defines an open lumen that facilitates drainage; Figures 1-2 and Abstract); and
a protective tube 11 telescopically disposed in the second cavity of the handle (Figure 1; paragraphs [0046-0050]);
wherein the protective tube 11 is adapted to telescope out of the second cavity of the handle to cover and protect at least a portion of the insertion portion of the catheter tube (as shown in Figures 1, 2, and 3A; see paragraph [0046]; and
wherein the protective tube 11 is adapted to retract into the second cavity of the handle to fully expose an entire length of the insertion portion of the catheter tube 12 for insertion into the urethra (as shown in Figure 3A-3D; see paragraphs [0047-0050]).
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Annotated Figure 1 of Paulen
Paulen does not specifically teach that the urinary catheter is an intermittent urinary catheter, wherein the catheter comprises a plurality of drain openings formed in a longitudinal direction along a proximal portion of the catheter tube.
Carleo teaches an intermittent urinary catheter assembly comprising a catheter tube 12 and a protective tube 10 surrounding the catheter tube (Figures 1-4; paragraphs [0034] and [0057]), wherein the protective tube 10 is configured to contain a lubricious coating and cover the catheter tube 12 prior to use to maintain sterility (paragraphs [0060-0062]. The catheter tube comprises a plurality of drain openings 20 formed in a longitudinal direction along a proximal portion of the tube (Figure 3; paragraph [0062]). These openings allow entry of urine from the patient’s bladder and provide enhanced flexibility at the proximal end of the catheter [0062], thereby providing an intermittent catheter that is comfortable for the patient to use ([0057] and [0062]). It would have been obvious to one of ordinary skill in the art to modify Paulen’s catheter assembly to replace the catheter tube 11 and inserted element (20-25; Figure 1 of Paulen) with an intermittent urinary catheter having a plurality of openings spaced longitudinally at the proximal tip thereof, as suggested by Carleo, in order to provide a sterile and comfortable intermittent catheter system that can easily be used by the patient ([0062] of Carleo.
With respect to Claim 2, Paulen teaches that the second cavity of positioned coaxially of the first catheter (Figure 1; paragraph [0046]).
With respect to Claim 3, Paulen teaches that the catheter tube 12 is fixedly connected to the handle 10 (Figure 1). Specifically, the catheter is integrally formed with the handle, as illustrated in the annotated figure below:
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Annotated Figure 1 of Paulen
With respect to Claim 5, Paulen teaches that the handle 10 comprises a flange stop adapted to prevent the protective tube 11 from detaching from the handle. See the annotated figure below and paragraphs [0048-0050].
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Annotated Figure 1 of Paulen
With respect to Claim 8, Paulen teaches that the protective tube 11 comprises a tip protrusion 18 at the proximal end thereof, the tip protrusion being sized to prevent the proximal end of the protective tube from entering the handle. See Figures 3A-3C; paragraphs [00447] and [0050]).
Claims 6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Paulen and Carleo as applied to claim 1 above, and further in view of Tanhoj (US 2004/0158231).
With respect to Claim 6, Paulen and Carleo reasonably suggest the intermittent urinary catheter of Claim 1, but do not specifically teach that the assembly comprises a container attachable to the handle and adapted for enclosing the catheter tube and protective tube during storage of the catheter assembly.
Tanhoj teaches intermittent urinary catheter comprising a catheter section 20 and a handle (44 and 50) and a container 46 that is attachable to the handle via flange 47, the container 46 being configured to surround and cover the catheter to hold a lubricating/swelling material and maintain a sterile environment during packaging, shipping and storing of the catheter prior to use (See Figures 4-6 and paragraphs [0037], [0057], and [0061-0062]). It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to further modify the catheter of Paulen and Carleo to have a container connected to the handle that surrounds the catheter and protective tube prior to use, as suggested by Tanhoj, in order to provide a well-known means for holding a fluid material and/or maintaining the sterility and catheter system during storage.
With respect to Claim 7, Paulen, Carleo, and Tanhoj reasonably suggest the catheter assembly of Claim 6, and Tanhoj further teaches that the container 46 and handle (44, 50) have complementary snap-fit elements (Figure 4). Specifically, the container 46 comprises an inwardly-protruding flange 47 and the handle (44, 50) comprises a corresponding indentation (Figure 4), such that the container is configured to couple to the handle prior to use (paragraph [0062]). It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to further modify the catheter assembly of Paulen, Carleo, and Tanhoj to have Tanhoj’s snap-fit assembly between the container and housing, in order to provide a well-known means for securing the container to the handle and to move the handle portion 50 into position to expose the catheter when the container is removed prior to use [0062].
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Paulen and Carleo as applied to claim 1 above, and further in view of Elgerot (SE 505615 C2; see the provided translation).
With respect to Claim 14, Paulen and Carleo reasonably suggest the catheter assembly of claim 1, but do not specifically teach that the protective tube comprises two protective tube parts, the two parts being telescopically movable with respect to each other in a longitudinal direction of the catheter assembly.
Elgerot teaches a catheter assembly for use as a urinary catheter (see entire disclosure, especially Title and Page 2, Line 6) comprising a central, body-inserted catheter tube 14 and a plurality of outer protective tubes (11-13), wherein the tubes (11-14) are configured to telescopically extend between a withdrawn configuration (Figure 4) and an extended position (Figures 1 and 3). Elgerot teaches that this telescoping configuration makes the catheter assembly more compact such that it may be easily transported by the user (Page 3, Lines 2-5). It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to further modify the catheter assembly of Paulen and Carleo to have a telescoping protective tube comprising at least two telescoping tube portions, as suggested by Elgerot, in order to make the catheter system more compact.
Allowable Subject Matter
Claim 9 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claims 10-11 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.
The following is a statement of reasons for the indication of allowable subject matter:
With respect to Claim 9, the prior art does not teach that the container comprises an inwardly protruding flange adapted to provide a detachable snap-fit that cooperates with and couples the container to the tip protrusion of the protective tube. The closest prior art is Paulen, which has a cover 13, but the cover is only coupled to the protective tube (not to the handle, as required in claim 6). While Tanhoj teaches a cover that couples to the handle, it is unclear why one of ordinary skill in the art would have provided flanges to couple the cover to both the handle and the protective tube.
The examiner notes that claim 9 also recites the tip protrusion introduced in Claim 8. Accordingly, claim 9 has been interpreted as being dependent from and requiring the subject matter of Claims 1, 6, and 8. Appropriate correction is required.
With respect to Claims 10-11, the prior art does not teach or suggest that the protective tube and container each comprises complementary shaped releasable snap-fit connections adapted to telescope the protective tube out of the second cavity of the handle as the container is removed from the handle.
The closest prior art is Paulen, which teaches the use of a cap 13 to hold the protective tube in the position where it is extended from the second cavity, as illustrated in Figures 2 and 3A. It is unclear why one of ordinary skill in the art prior to the effective filing date would have modified Paulen’s catheter to have the protective tube in the retracted position while a cover is in place, because Paulen explicitly teaches that the protective tube 11 should cover the catheter 12 during storage to maintain an antiseptic, lubricating gel 15 in contact with the outer surface of the catheter 12 (paragraph [0030] and [0046]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Tierney et al. (US 2019/0143078) teaches an intermittent catheter system comprising a catheter tube and a slidable protective sleeve.
Borodulin (US 2009/0054876) teaches a compact intermittent catheter system comprising a cover and a plurality of snap-fitting elements.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Philip R Wiest whose telephone number is (571)272-3235. The examiner can normally be reached M-F 9-6 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PHILIP R WIEST/ Primary Examiner, Art Unit 3781