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 .
Claim Status
The amendments presented January 26th, 2026 have been entered. Claims 1 and 4-11 are currently pending. Claims 2, 3, and 12-25 are cancelled. Claims 1 and 9 have been amended.
Response to Arguments
Applicant's arguments filed January 26th, 2026 have been fully considered but they are not persuasive.
Applicant’s arguments with respect to claim(s) 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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(s) 1 and 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith (U.S. Patent No. 6,413,250) in view of Averill (U.S. Publication 2016/0176589).
Regarding claims 1 and 4, Smith discloses a urinary catheter drainage member (Figs. 3 and 7; Col. 4 lines 7-24 used as a urinary catheter), comprising: a body (Fig. 3) having a proximal end, a distal end (see illustrative diagram of Fig. 7 below) and a lumen extending therethrough (cylindrical cavity 16), the proximal end being configured to be located at the distal end of a catheter shaft such that the lumen of the body is in fluid communication with a drainage lumen of the catheter shaft (See illustrative diagram of Fig. 7 below), the distal end of the body defining an opening for urine drainage (opening of 16 at distal end can be seen clearly in Fig. 1); and
wherein the body includes a natural configuration (Fig. 3) wherein urine flows from the drainage lumen of the catheter shaft and out of the opening defined by the distal end of the body (Col. 3 lines 56-65 Fig. 3 position opens the fluid passage through the body) and an engaged configuration (Fig. 7) wherein the outer surface of the body is engaged to selectively restrict urine drainage (; and
wherein the body has an outer surface (surface opposite the surface facing cavity 16) and the body includes a notch 24 formed on the outer surface, wherein in the engaged configuration a distal portion of the body folds toward the proximal end of body (element 22 folds into seat 26 which is a more proximal position to the proximal end and thus folding toward the proximal end) at the one or more notches to selectively restrict urine drainage from the opening (Col. 3 lines 43-45 when the bulge zone has snapped into the cavity of the body the valve member is closed firmly onto its seat to obturate the sleeve bore).
Smith does not expressly disclose the distal end folding or twisting relative to the proximal end of the body at the one or more notches (Claim 1) or the one or more notches comprising a circumferential groove extending around the body (Claim 4).
However, Averill, in the same field of endeavor of closing fluid transporting pathways (Abstract closure having an open configuration and a closed configuration), teaches a closure element for a fluid pathway (Fig. 1b and 1c) including a body that includes a natural configuration Fig. 1B where fluid is allowed to flow from a fluid source and out of an opening 64 defined by the distal end 56 of the body and an engaged configuration (Fig. 1C) wherein the outer surface of the body is engaged to selectively restrict fluid flow (¶0019 Fig. 1c shows device in the closed configuration; ¶0032 pour spout is “kinked” and prevents liquid from being poured from the bottle); and
wherein the body has an outer surface (¶0031 outer side) and the body includes a notch 60 formed on the outer surface (¶0031 annular groove circumscribes the outer side of the pour spout, wherein in the engaged configuration the distal end 56 of the body folds toward the proximal end 22 of body (Fig. 1C shows edge 56 folded toward edge 22) at the one or more notches to selectively restrict urine drainage from the opening (¶0032 pour spout is “kinked and prevents liquid from being poured from the bottle) wherein the one or more notches comprises a circumferential groove 60 extending around the body (¶0031 circumscribes the outer side of the pour spout and divides the pour spout upper portion from the lower portion).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the notch and closure element of Smith that performs the function of allowing for a bending of the device to selectively close a fluid pathway for the notched closure element of Averill since these elements perform the same function of allowing the bending of the device in such a fashion as to selectively close the device upon a user actuating the bending of the device along the notch. Simply substituting one selective closure means for another would yield the predictable result of allowing a(n) fluid flow pathway to be selectively closed upon bending the device along the notch. See MPEP 2143.
Claim(s) 5-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith (U.S. Patent No. 6,413,250) in view of Averill (U.S. Publication 2016/0176589) and Lovmar (U.S. Publication 2019/0262579).
Regarding claims 5-6, Smith in view of Averill suggest the urinary catheter drainage member of claim 1. Smith further discloses a top wall (Zone 20) and a bottom wall (remainder of wall 12 that does not form zone 20) that are moved into contact with each other (22 moved into contact with wall 12 at point 26) to restrict urine drainage from the opening (Col. 3 lines 43-45 when the bulge zone has snapped into the cavity of the body the valve member is closed firmly onto its seat to obturate the sleeve bore) (Claim 6). Smith does not expressly disclose the distal portion of the body including a generally oval shape (Claim 5).
However, in the same field of endeavor of urinary catheters, Lovmar discloses a distal end of a catheter (¶0010 flared rearward end) having either a circular cross-section or non-circular cross sections, such as oval or elliptical cross-sections (¶0010 even though the flared rearward end may have a circular cross-section, it is to be acknowledged by the skilled addressee that non-circular cross-sections, such as oval or elliptical cross-sections are also feasible).
it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the distal end of the body disclosed by Smith to have been oval in shape as a change in shape is considered a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed element is significant (See MPEP 2144.04 changes in shape; In re Dailey, 357 F.2d 669, 149 USPQ 440 (Bd. App. 1959)). Applicant has provided no persuasive evidence that the particular configuration of the distal end is significant (see Applicant's Specification Paragraph [0023] illustrative body has a generally round-cross-section, the cross-section of the body may have other shapes, including but not limited to rectangular, oval, etc.), therefore modifying the distal end of the body of Smith in view of Averill to be oval as disclosed by Lovmar would have been an obvious modification to one of ordinary skill in the art. Furthermore, Lovmar has disclosed the changing of shape of the distal end of the catheter to be within the ordinary skill of one of the art as disclosed in ¶0010 stating it is to be acknowledged by the skilled addressee that non-circular cross-sections, such as oval or elliptical cross-sections are also feasible.
Regarding claim 7, Smith in view of Averill and Lovmar suggest the urinary catheter of claim 5. Smith does not expressly disclose the top and bottom wall being bent, pinched, or kinked. However, the limitations of “bent pinched or kinked” are considered functional language (¶0028 distal portion is made from flexible material and is configured to be pinched or bent by an external stimulus, including the force of a user’s fingers, in order to narrow the opening, for example, a user may place a thumb over the top wall and an index finger below the bottom wall and squeeze the walls closer together). While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the device of Smith in view of Averill and Lovmar suggest all the structure as claimed, and is further pressed in order for the top and bottom walls to come together to close the pathway (Col. 3 lines 35-36 bulge zone pressed downwardly into the cavity of the body). As such, it is capable of being pinched (i.e. it is capable of a user placing a thumb over the bulge zone 20 and an index finger below the bottom wall 12 and squeezing the walls closer together).
Claim(s) 8-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith (U.S. Patent No. 6,413,250) in view of Averill (U.S. Publication 2016/0176589) and Andersin et al. (U.S. Publication 2019/0358435).
Regarding claim 8-11, Smith in view of Averill suggest the urinary catheter drainage member of claim 1. Smith further discloses the distal portion of the body having opposing walls (zone 22 and wall 12 outside of zone 22) that may be brought into contact with each other (22 moved into contact with wall 12 at point 26) (Claim 9), wherein the distal portion of the body defines opposed surfaces (zone 22 and wall 12 outside of zone 22), and the opposed surface may be brought into contact with one another (22 moved into contact with wall 12 at point 26) (Claim 10), with Smith as modified by Averill above in the rejection of claim 1 suggesting the drainage member being kinked (Fig. 1C of Averill) such that a proximal portion is moved in the direction of the distal portion (portion distal to the notch moves toward portion before the notch, i.e. the proximal portion) (Claim 11).
Smith does not expressly disclose the distal portion of the body having a truncated pyramid shape.
However, Andersin, in the same field of endeavor of urinary catheters, teaches a body 12 having a distal end (end of 12 opposite end proximal to 11) and a proximal end (end proximal element 11) and a distal portion of the body having a truncated pyramid shape (Fig. 2 shows rectangular cross section of element 12 with tapering from distal to proximal end which results in truncated pyramid shape from distal end to element 15a, ¶0075 urinary catheter assembly having a generally circular cross-section, however, as discussed in the foregoing the assembly may also have other shapes, such as being of a square or rectangular shape ¶0076 rear end is funnel-shaped which indicates tapering of sides, tapering sides coupled with a square or rectangular shape results in truncated pyramid)
it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the distal end of the body disclosed by Smith to have been in a truncated pyramid shape as a change in shape is considered a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed element is significant (See MPEP 2144.04 changes in shape; In re Dailey, 357 F.2d 669, 149 USPQ 440 (Bd. App. 1959)). Applicant has provided no persuasive evidence that the particular configuration of the distal end is significant (see Applicant's Specification Paragraph ¶0011 distal portion shaped in a truncated pyramid; ¶0029 distal portion has a truncated pyramid shape), therefore modifying the distal end of the body of Liu to be oval as disclosed by Andersin would have been an obvious modification to one of ordinary skill in the art. Furthermore, Lovmar teaches that providing different shaped cross-sections was well known in the art before the effective filing date of the claimed invention.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PETER DANIEL SMITH whose telephone number is (571)272-8564. The examiner can normally be reached Monday - Friday 7:30am-5:00pm.
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/PETER DANIEL SMITH/Examiner, Art Unit 3781
/JESSICA ARBLE/Primary Examiner, Art Unit 3781