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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 07/21/2026 has been entered.
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, 14-18, 55 and 56 are rejected under 35 U.S.C. 103 as being unpatentable over either Becker (US 2022/0054295) or Murray (12,383,700) in view of Gellman (US 8,007,464).
Claim 1
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]).
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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 above); 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 above and column 6 lines 32-37).
None of Becker or Murray discloses one or more annular members, as required. However, Gellman discloses a medical device (11) comprising catheters tubes (10 or 12) each including at least one balloon/annular member (14 or 16) (see column 4 lines 26-39) disposed over the catheter tubes and within lumen (30) (see figure 3A). Gellman discloses the annular members are slidably disposed over the catheter tubes because the annular members have to be positioned within the lumens and over the surface of the catheter tubes and then expanded to secure the position of the catheter tubes within the lumen, and wherein the spacing between the expansible members (see column 6 lines 10-46). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify any of Becker or Murray including at least one balloon/annular member over the catheter tube as taught by Gellman to secure the position of the catheter tube within the storage sheath.
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 55
Gellman discloses the annular members are capable as stocky handling points capable to allow of low-dexterity users handling the intermittent-catheter assembly during catheterization.
Claim 56
After any of Becker or Murray is modified by Gellman, the distal end piece would slidably combines with the one or more annular members to form a conglomerated handle for low-dexterity users when handling the intermittent-catheter assembly during the catheterization.
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 with respect to claims 1 and 14-18 have been considered but are moot in view of a new ground of rejection.
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).
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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