DETAILED ACTION
Note: The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This Office action is in response to communications filed June 9, 2026.
Status of Claims
1. Claims 1-22 are pending and currently under consideration for patentability.
Response to Arguments
2. Applicant’s arguments, see pages 6-10, filed June 9, 2026, with respect to claims 1-12 have been fully considered and are persuasive. The rejection of claims 1-12 has accordingly been withdrawn and considered allowable over the prior art of record below.
Applicant’s arguments with respect to claim(s) 13 have been considered but are moot because the new ground of rejection does not rely on the same combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Bierman et al. (US PGPUB 2004/0034330 A1), which was previously utilized as a secondary reference in rejecting claim 13, is now a primary reference in the present rejection below, in view of the amended claim. Cianci (US 4,149,539) previously cited as pertinent prior art of record not relied upon for rejection, is being utilized herein as a secondary reference.
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
3. Claim(s) 13-15, 17-20 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Bierman et al. (US PGPUB 2004/0034330 A1) in view of Cianci (US 4,149,539).
4. With regard to claims 13-14 and 17, Bierman discloses a method of retaining a catheter (medical anchoring system; abstract; Figs. 1, 4, 8, 9, 11), comprising: placing a portion of the catheter (medical article, 130) in a channel (receptacle channel, 260) defined by a catheter tube sleeve (compressible channel support, 250) extending through a base (150) of a retainer (120) and engage the portion of the catheter (130) in a friction fit engagement ([0007]; [0012-0013]; [0023]; [0053]; [0067]; Figs. 17-19); transitioning a cap (cover, 200) hingedly coupled to the base (150) of the retainer (120) from an open position (Fig. 1) to a closed position (Fig. 3; [0052-0053]); imparting a non-linear, serpentine shape having one or more inflection points, on the portion of the catheter (130) disposed within the channel (260) of the catheter tube sleeve (250; Figs. 4, 7, 8, 11, 13; [0053]; [0080]; [0143]; [0148]); and securing the portion of the catheter (130) within the catheter tube sleeve (250; Figs. 17-19; [0051-0054]; [0081]; [0096-0101]).
However, Bierman is silent in regard to a catheter tube sleeve extending from the base of the retainer.
Within the same field of catheter securement, Cianci discloses a hemostatic device (16; abstract; Figs. 1-5, 8, 10) comprising catheter (20) and a traction member (18) having a retaining portion (40); wherein a portion of the catheter (20) is placed in a channel defined by a catheter tube sleeve (indicating member, 58 including generally tubular section, 60) extending from a base of the retaining portion (40; Figs. 4, 8, 10; col. 3, line 63 – col. 4, line 5; col. 4, line 45 – col. 5, line 2).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the retainer disclosed by Bierman to include a catheter tube sleeve extending from its base, similar to that disclosed by Cianci, in order to allow for the determination of the amount of tension in the shaft of the inserted catheters employing reference markings on their exterior, as suggested by Cianci in column 4, line 45 to column 5, line 2, while further extending the length of the supportive, pliant and compressible catheter tube sleeve of Bierman to accommodate tubes of different diameters, as suggested by Bieman in paragraph [0054].
5. With regard to claim 15, Bierman is silent in regard to the portion of the catheter includes a proximal end of a catheter tube supported by a bifurcation, the bifurcation disposed within a channel of the base of the retainer, a portion of the bifurcation abuts against a surface of the base of the retainer.
However, Cianci discloses that the portion of the catheter (20) includes a proximal end (32) of a catheter tube (22) supported by a bifurcation (at connection to side arm, 34; Fig. 3), the bifurcation disposed within a channel (bore, 42 and side channel, 44) of the base of the retainer (40), a portion of the bifurcation abuts against a surface (walls of bore 42 and side channel 44; Figs. 8, 10) of the base of the retainer (40; col. 3, lines 16-49).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the retainer disclosed by Bierman to accommodate a bifurcation of the catheter, similar to that disclosed by Cianci, in order to employ the clamping retainment with common bifurcated balloon catheters, and firmly retain the catheter, at the bifurcated junction, therein, as suggested by Cianci in column 3, lines 35-49.
6. With regard to claim 18-19, Bierman, as modified by Cianci, discloses the catheter tube sleeve as required by claim 13 above. Further, Bierman discloses that the retainer (150/200 of 120; Fig. 4) is formed of a first material and the catheter tube sleeve (250) is formed of a second material, the first material defining relatively rigid material characteristics, the second material defining relatively more flexible material characteristics than the first material ([0022]; [0065]); and that the catheter (130) is formed of a third material that is relatively more flexible than the second material (inherently, otherwise catheter would not take serpentine shape; [0124-0130]).
7. With regard to claim 20, While Cianci clearly discloses that a tip of the catheter tube sleeve (60) extends a distance from the retainer (40; Figs. 8, 10), Bierman and Cianci fails to explicitly disclose that a tip of the catheter tube sleeve extends a distance of 1 inch or greater from the base of the retainer.
However, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the length of the catheter tube sleeve disclosed by Bierman in view of Cianci to extend a distance of 1 inch or greater, since it has been held that where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. See MPEP 2144.04(IV)(A). In the instant case, one having ordinary skill in the art would recognize that the catheter tube sleeve should employ a minimum length in order to achieve its desired function of securement/retainment.
8. With regard to claim 22, Bierman discloses that a distal tip of the catheter is configured to be disposed within a body cavity of a patient and drain fluid therefrom ([0002]; [0004-0005]; [0007]; [0048]; [0158]).
Additionally, Cianci discloses that a distal tip of the catheter (20) is configured to be disposed within a bladder of a patient and drain urine therefrom (col. 4, lines 25-44).
9. Claim(s) 21 is rejected under 35 U.S.C. 103 as being unpatentable over Bierman in view of Cianci, as applied to claim 13 above, and further in view of Olson et al. (US PGPUB 2020/0206468 A1).
10. With regard to claim 21, Bierman discloses adhering a lower surface of an anchor pad (110) to a skin surface of a patient ([0049]; [0051-0052]; [0056-0057]).
However, Bierman and Cianci are silent in regard to an upper surface of the anchor pad rotatably coupled to the base of the retainer.
Within the same field of catheter securement, Olson discloses a method of retaining a catheter (20; abstract; Figs. 11-24; [0067-0068]; [0076]), comprising: placing a portion of the catheter (20) in a channel (non-branching portion of 50 extending away the bifurcation toward the catheter tip; see annotated Fig. 13 above) extending from a retainer (50; Figs. 11-12); and adhering a lower surface of an anchor pad (30) to a skin surface of a patient ([0068]; [0072]), an upper surface of the anchor pad (30) rotatably coupled to the base of the retainer (50; [0068-0069]).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the upper surface of the anchor pad disclosed by Bierman in view of Cianci to be rotatably coupled to the base of the retainer, similar to that disclosed by Olson, in order to support and stabilize the catheter while avoiding placing unnecessary stress, strain, or disturbance to the patient's urethra tube and the Foley-style balloon inside the bladder of the patient during movement, as suggested by Olson in paragraph [0069].
Allowable Subject Matter
11. Claims 1-12 are allowed.
12. Claim 16 is 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:
The closest prior art of record, while disclosing a similar retainer system and method to that of the instant invention, fails to reasonably disclose or suggest, alone or in combination, the unique combination of claimed structure and method steps, wherein the base further includes one or more extension leg sleeves extending from a first side of the base of the retainer, the catheter tube sleeve extending from a second side of the base, opposite the first side, as required by claims 1 and 16.
Conclusion
13. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
14. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW J MENSH whose telephone number is (571)270-1594. The examiner can normally be reached M-F 9 a.m. - 6 p.m..
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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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/ANDREW J MENSH/ Primary Examiner, Art Unit 3781
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