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 .
Information Disclosure Statement
Applicant should note that the large number of references in the attached IDS(s) have been considered by the examiner in the same manner as other documents in Office search files are considered by the examiner while conducting a search of the prior art in a proper field of search. See MPEP 609.05(b). Applicant is invited to point out any particular reference(s) in the IDS that they believe may be of particular relevance to the instant claimed invention in response to this Office Action. See also MPEP 2004, example 13, it is desirable to avoid the submission of long lists of documents if it can be avoided. If a long list is submitted, highlight those documents which have been specifically brought to applicant’s attention and/or are known to be of most significance. See Penn Yan Boats, Inc. v. Sea Lark Boats, Inc., 359 F. Supp. 948, 175 USPQ 260 (S.D. Fla. 1972), aff’d, 479 F.2d 1338, 178 USPQ 577 (5th Cir. 1973), cert. denied, 414 U.S. 874 (1974). But cf. Molins PLC v. Textron Inc., 48 F.3d 1172, 33 USPQ2d 1823 (Fed. Cir. 1995).
Claim Rejections - 35 USC § 102
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.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Becker (US 2022/0054295).
Becker discloses an intermittent-catheter system comprising an intermittent-catheter assembly (100) including an intermittent catheter (defined by catheter extending within structure 15) (see [0064]) including a catheter tube and a connecting funnel (13) over a proximal end portion of the catheter tube for draining urine from the intermittent catheter (see [0062]); a distal end piece (14) slidably disposed over a distal end portion of the catheter tube; and a storage sheath (15) between the connecting funnel and the distal end piece, a combination of the connecting funnel, the distal end piece, and the storage sheath configured to enclose an entirety of the catheter tube therein (see figure 1); and
a drainage bag (1) including a connecting spout (8) connected to the connecting funnel of the intermittent catheter in at least an unused state of the intermittent-catheter system (see [0065]).
Claims 1 and 14-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Murray (12,383,700).
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Claim 1
Murray discloses an intermittent-catheter system, comprising an intermittent-catheter assembly (60) including an intermittent catheter including a catheter tube (12) and a connecting funnel (22) over a proximal end portion of the catheter tube for draining urine from the intermittent catheter (see column 6 lines 27-29); a distal end piece (34) slidably disposed over a distal end portion of the catheter tube (see column 3 lines 55-56); and a storage sheath (18) between the connecting funnel and the distal end piece, a combination of the connecting funnel, the distal end piece, and the storage sheath configured to enclose an entirety of the catheter tube therein (see figure 10); and a drainage bag (62) including a connecting spout (68) connected to the connecting funnel of the intermittent catheter in at least an unused state of the intermittent-catheter system (see figure 10 and column 6 lines 32-37).
Claim 14
Murray further discloses the connecting funnel is connected to the distal end piece of the intermittent-catheter assembly in an end-to-end connection through a first arm of the connecting funnel, and the connecting funnel of the intermittent catheter is also connected to the connecting spout of the drainage bag through a second arm of the connecting funnel (see figure above).
Claim 15
Murray further discloses wherein the distal end piece of the intermittent-catheter assembly includes a first male fitting (defined by introducer 34) extending from the distal end piece, and the first arm of the connecting funnel includes a first female fitting (defined by end portion of the funnel 22) within the first arm capable/configured to receive the first male fitting (see figure 8).
Claim 16
Murray further discloses wherein the first arm of the connecting funnel includes a first fluid seal disposed within the first female fitting of the first arm, the first fluid seal capable/configured to accept the first male fitting of the distal end piece therethrough (see column 4 lines 27-30 and figure 8).
Claim 17
Murray further discloses the end-to-end connection between the first arm of the connecting funnel and the distal end piece of the intermittent-catheter assembly is configured to maintain sterility of the catheter tube of the intermittent catheter within the combination of the connecting funnel, the distal end piece, and the storage sheath in at least the unused state of the intermittent-catheter system (see column 1 lines 64-67 and column 2 lines 1-20).
Claim 18
Murray further discloses the end-to-end connection between the first arm of the connecting funnel and the distal end piece of the intermittent-catheter assembly is configured to prevent residual urine in the intermittent catheter from leaking from the intermittent catheter in a used state of the intermittent-catheter system. Murray discloses end of the funnel (22), provided with a liquid tight seal (see column 4 lines 27-30), therefore is configured to prevent leakage of urine residual
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.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Murray (12,383,700) or Becker (US 2022/0054295) as applied to claim 1 above, and further in view of Yang (CN 2532840).
None of Murray or Becker discloses the drainage bag is in a compact rolled form in at least the unused state of the intermittent-catheter system. However, Yang discloses rolling up drainage bags is a known practice for reducing size (see abstract). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Murray or Becker having the drainage bag rolled up, in the unused state, as taught by Yang for reducing the size of the bag when in storage.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Murray (12,383,700) or Becker (US 2022/0054295) as applied to claim 1 above, and further in view of Steer (4,496,354).
Becker appears to disclose the drainage bag is in compact bellowed form (see figure 1). None of Murray or Becker explicitly disclose the drainage bag is in a compact bellowed form in at least the unused state of the intermittent-catheter system. However, Steer discloses a drainage bag comprising first wall (10) and second wall (12) (see column 2 lines 62-65), wherein the second wall comprises bellows for achieving internal expansion (see column 4 lines 6-9). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the drainage bag of Murray or Becker having bellows form as taught by Steer for maximizing the internal space of the bag when expanded.
Allowable Subject Matter
Claims 19-22 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.
Response to Arguments
Applicant's arguments filed 04/13/2026 have been fully considered but they are not persuasive. Regarding applicant’s argument of the teachings of Murray for claim 1, the examiner disagrees. No limitation in claim 1 prevents the bag/holder of Murray to be used and/or considered as a drainage bag. Murray, column 7 lines 4-18, discloses sterilization fluid is dispensed into the holder/drainage bag (62) through structure (68) (before use), then the user compress the holder/drainage bag to agitate the fluid within the catheter product (60) so it is ready to be used, wherein in this case, the holder bag (62) is considered as a drainage bag. Regarding applicant’s argument for the rejection of claims 23 and 24, the examiner never intended to substitute one drainage bag for another. The examiner points out that the drainage bag of Murray is a flexible bag by the fact is made from elastic material, therefore has the capability to be folded. Yang discloses the drainage bag in no-use can be rolled for reducing the volume and weight of the drainage bag. With respect to the arguments of claim 24, no intention to substitute the drainage bag, but a modification with bellows is disclosed so changing of the internal space within the drainage bag can be achieved.
Conclusion
Examiner has cited particular paragraphs and/or columns and line numbers in the references as applied to the claims above for the convenience of the applicant. Although the specified citations are representative of the teachings of the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested of the applicant, in preparing responses, to fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or prior art(s) disclosed by the Examiner (in the attached PTO-892 form).
Applicant's submission of an information disclosure statement under 37 CFR 1.97(c) with the timing fee set forth in 37 CFR 1.17(p) on 01/12/2026 prompted the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 609.04(b). 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 RAFAEL A. ORTIZ whose telephone number is (571)270-5240. The examiner can normally be reached Monday - Friday 9am - 6pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Orlando E. Aviles can be reached at 571-270-5531. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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RAFAEL A. ORTIZ
Primary Examiner
Art Unit 3736
/RAFAEL A ORTIZ/Primary Examiner, Art Unit 3736
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