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 .
Status of Claims
1. Claims 1-22 are pending and currently under consideration for patentability.
Information Disclosure Statement
2. The information disclosure statements (IDS) submitted on May 31, 2024 and August 1, 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
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.
3. Claim(s) 1 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Olson et al. (US PGPUB 2020/0206468 A1).
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4. With regard to claim 1, Olson discloses retainer system (external catheter stabilizer, 10; abstract; Figs. 11-24; [0067-0068]; [0076]), comprising: a catheter (catheter tube, 20) having a bifurcation disposed at a proximal end of a catheter tube and a drainage extension leg (drainage by means of a Foley catheter; [0074]; Fig. 15) and an inflation extension leg extending proximally from the bifurcation (inflating of the Foley catheter; [0076]; Fig. 15); an anchor pad (skin adhesive patch, 30) defining a bottom surface and a top surface ([0068]; [0086]; Figs. 11, 13, 14); and a retainer (a catheter stabilizer containment retainer, 50) coupled to the top surface of the anchor pad (30) and defining a first side and a second side (Figs. 11, 12; [0076-0078]), opposite the first side, the retainer (50) comprising: a base (40); a cap (see hinged cap of retainer, 50; Figs. 11, 12 and annotated Fig. 13 above) hingedly coupled to the base (40; “somewhat rigid plastic as one piece incorporating molded-into place “living” plastic hinges to allow for opening and closing the retainer 50 and at least one molded-in plastic latch mechanism to secure the retainer 50 in the closed position”; [0068]); one or more extension leg sleeves (branching portion of 50 extending toward the bifurcation; see annotated Fig. 13 above) defining a lumen and extending from the first side of the retainer (50); and a catheter tube sleeve (non-branching portion of 50 extending away the bifurcation toward the catheter tip; see annotated Fig. 13 above) defining a lumen and extending from the second side of the retainer (50; [0076-0079]).
5. With regard to claims 2, 4 and 10-12, Olson discloses that the retainer base (40) defines a bifurcation channel configured to receive the bifurcation and communicates with the lumen of the catheter tube sleeve (Figs. 11-13; [0076-0078]); wherein the catheter tube sleeve lumen (of 50) defines an inner diameter equal to or greater than an outer diameter of the catheter tube (20; Fig. 12; [0076-0078]); wherein the retainer (50) is rotatably coupled to the top surface of the anchor pad (30; [0068-0069]); wherein the anchor pad (30) includes an adhesive layer disposed on the bottom surface and configured to secure the anchor pad to a skin surface of a patient ([0068]; [0072]); and wherein a distal tip of the catheter (20) is configured to be disposed within a bladder of a patient and drain urine therefrom (Fig. 1; [0002-0003]; [0060]).
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.
6. Claim(s) 9 is rejected under 35 U.S.C. 103 as being unpatentable over Olson.
7. With regard to claim 9, while Olson discloses that the anchor pad (30) has the dimensions of about 4 inches by 4 inches 9 ([0068]), Olson is silent in regard to a tip of the catheter tube sleeve (see annotated Fig. 13 above) extending a distance of 1 inch or greater from the second side 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 Olson 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 retainment.
8. Claim(s) 3, 13-17 and 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over Olson in view of Bierman et al. (US PGPUB 2004/0034330 A1).
9. With regard to claim 13, 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 defined by a catheter tube sleeve (non-branching portion of 50 extending away the bifurcation toward the catheter tip; see annotated Fig. 13 above) extending from a base (40) of a retainer (50; Figs. 11-12); transitioning a cap (see hinged cap of retainer, 50; Figs. 11, 12 and annotated Fig. 13 above) of the retainer (50) from an open position to a closed position (“somewhat rigid plastic as one piece incorporating molded-into place “living” plastic hinges to allow for opening and closing the retainer 50 and at least one molded-in plastic latch mechanism to secure the retainer 50 in the closed position”; [0068]); and securing the portion of the catheter (20) within the catheter tube sleeve (of 50; [0076-0079]).
However, Olsen is silent in regard to imparting a non-linear shape on the portion of the catheter disposed within the channel of the catheter tube sleeve.
Within the same field of endeavor (catheter retainment devices), Bierman discloses a medical anchoring system (abstract; Figs. 1, 4, 8, 9, 11), comprising a catheter (medical article, 130) and a retainer (120) connected to an anchor pad (110; [0132-0133]); and imparting a non-linear shape on the portion of the catheter (130) disposed within a channel (curved/serpentine catheter channel, 260) of the retainer (120; Figs. 17-19; [0053]; [0080]; [0143]; [0148]).
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 method of retaining the catheter disclosed by Olson, to include the step of imparting a non-linear shape on the portion of the catheter disposed within the channel of the catheter tube sleeve, similar to that disclosed by Bierman, in order to increase the resistance to axial motion of the tube, as suggested by Bierman in paragraph [0080], leading to the catheter tubing being less susceptible to crimping and kinking, as suggested by Bierman in paragraph [0150].
10. With regard to claims 3 and 14, Olson is silent in regard to the catheter tube sleeve lumen defining a non-linear path having one or more inflection points.
However, Bierman discloses a medical anchoring system (abstract; Figs. 1, 4, 8, 9, 11), comprising a catheter (medical article, 130) and a retainer (120) connected to an anchor pad (110; [0132-0133]); and the retainer (120) defining a non-linear path having one or more inflection points (curved/serpentine catheter channel, 260; Figs. 17-19; [0053]; [0080]; [0143]; [0148]).
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 catheter tube sleeve disclosed by Olson, to include a non-linear path having one or more inflection points, similar to that disclosed by Bierman, in order to increase the resistance to axial motion of the tube, as suggested by Bierman in paragraph [0080], leading to the catheter tubing being less susceptible to crimping and kinking, as suggested by Bierman in paragraph [0150].
11. With regard to claims 15-17, 21 and 22, Olson discloses that the portion of the catheter (20) includes a proximal end of a catheter tube supported by a bifurcation, the bifurcation disposed within a channel of the base of the retainer (50; [0074]; Fig. 13), a portion of the bifurcation abuts against a surface of the base (40) of the retainer (50; [0076]; Figs. 11, 12, 15); wherein the base (40) further includes a first sleeve and second sleeve branching portion of 50 extending toward the bifurcation; see annotated Fig. 13 above) each extending from a first side of the base of the retainer (50), the catheter tube sleeve (non-branching portion of 50 extending away the bifurcation toward the catheter tip; see annotated Fig. 13 above) extending from a second side of the base (40), opposite the first side (Figs. 11-15; [0076-0078]); wherein the catheter tube sleeve engages the portion of the catheter (20) in a friction fit engagement ([0070-0072]; 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]); wherein a distal tip of the catheter (20) is configured to be disposed within a bladder of a patient and drain urine therefrom (Fig. 1; [0002-0003]; [0060]).
12. With regard to claim 20, while Olson discloses that the anchor pad (30) has the dimensions of about 4 inches by 4 inches 9 ([0068]), Olson and Bierman are silent in regard to a tip of the catheter tube sleeve (see annotated Fig. 13 above) extending 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 Olson in view of Bierman 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 retainment.
Allowable Subject Matter
13. Claims 5-8 and 18-19 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:
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, further requiring that the retainer is formed of a first material and one or both of the one or more extension leg sleeves and the catheter tube sleeve 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, as required by claims 5 and 18.
Claims 6-8 and 19 are objected to due to their dependency.
Conclusion
14. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Grandolfo (US PGPUB 2015/0025468) discloses an external end device for permanent catheters.
Wright et al. (US PGPUB 2007/0219500) discloses a universal catheter securement device.
Freed (US 5,398,679) discloses a hinged endotracheal tube holder having safety/securing clamp.
Cianci (US 4,149,539) discloses a hemostatic device.
15. 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..
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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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/ANDREW J MENSH/ Primary Examiner, Art Unit 3781