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 .
Response to Amendment
This office action is responsive to the amendment filed on 13 May 2026. As directed by the amendment: claims 1-3, 8, 9 & 14 have been amended and claim 17 has been added. Claims 10-13 were cancelled in a previous amendment. Thus, claims 1-9 & 14-17 are presently pending in this application.
Claim Objections
Claim 3 is objected to because of the following informalities:
“…wherein at least one longitudinally extending support…” should read “…where the at least one longitudinally extending support…”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 17 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1, from which claim 17 depends, recites that the at least one longitudinal support is “for…facilitating collapsing of the first component into the second component”. Claim 17 now recites “…the collapsing of the first component into the second component is facilitated by collapsing the first set of corrugations into the second set of corrugations”.
It is unclear if the “facilitated” limitation in claim 17 is intended to further define the means by which the longitudinal support in “facilitates” the collapse, or if they are meant to be separate features. Additionally, it is unclear if the collapsing of the first set of corrugations into the second set of corrugations is actually “facilitating” the collapse of the first component into the second component, or if this is merely the same action, described in further detail.
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.
Claims 1-7 & 14-17 (as understood) are rejected under 35 U.S.C. 103 as being unpatentable over Bigonzi-Jaker et al. (US 6,240,968; hereafter Bigonzi-Jaker) in view of Stalter et al. (US 2,143,960; hereafter Stalter).
Regarding claim 1, Bigonzi-Jaker discloses (e.g., figs. 6 & 6A) a tube (80; i.e., a tube formed from two polymeric film layers heat sealed along the longitudinal edges; see col. 9, lines 32-38) comprising: a first component (i.e., first membrane 77, forming one half of the tube body) and a second component (i.e., second membrane 78, forming the other half of the tube body) the tube having a first end (82), a second end (84), and a length in a longitudinal direction extending along the first component and the second component from the first end to the second end, and a width in a transverse direction transverse to the longitudinal direction; and
at least one longitudinally extending support (86, 88) formed along the length of the first and second components (as shown).
Bigonzi-Jaker does not explicitly disclose the additional limitations wherein the tube comprises a plurality of corrugations in the longitudinal direction formed along the length of the first and second components, or wherein the longitudinally extending support is configured for preventing stretching of the first and second components in the longitudinal direction.
Stalter teaches (figs. 1-4) a tube having a first portion (i.e., upper corrugated portion as oriented in the figures), a second portion (i.e., lower corrugated portion as oriented in the figures), a first end (at 10) and a second end (at 12), and a length in a longitudinal direction extending along the first and second portions from the first end to the second end (see fig. 1), and a width in a transverse direction transverse to the longitudinal direction (i.e., see figs. 1 & 2), a plurality of corrugations in the longitudinal direction formed along the first and second portions (see figs. 1 & 3; see pg. 2, left col., lines 66-68), and at least one longitudinally extending support formed along the length of the first and second portions (16; see figs. 1 & 2) and configured for preventing stretching in the longitudinal direction (see below).
Regarding the limitation wherein the at least one longitudinally extending support is configured for preventing stretching in the longitudinal direction, Stalter teaches that when the supports are located at the outer end relative to a bending action, the supports “act as tension members between adjacent corrugations and act to resist such bending action” (see pg. 2, right col., lines 25-35). As can be reasonably understood from that description, in combination with the figures, the configuration of the longitudinally extending supports acting as tension members between adjacent corrugations would also act to resist tension applied along the length of the hose, thus preventing stretching in the longitudinal direction.
Stalter explains that it is known to provide such corrugations to a flexible hose to enable such a hose to bend without kinking (see, e.g., pg. 1, right col., lines 16-24). Stalter further explains that, by providing the longitudinal supports extending transversely to the corrugations, the kink-resistance of the hose may be improved (pg. 2, left col., lines 32-38). By way of example, the longitudinal supports may aid in resisting bending actions in the plane of the supports, while permitting bending transverse to the support plane, and may further aid in preventing hose collapse in the event that torsional forces are applied to opposing ends of the hose (pg. 2, right col., lines 25-40).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the tube of Bigonzi-Jaker to comprise a plurality of corrugations in the longitudinal direction formed along the length of the first and second components, wherein the longitudinally extending supports are configured for preventing stretching of the first and second components in the longitudinal direction (i.e., by acting as tension members between adjacent corrugations), in view of the teachings of Stalter, as the use of a known technique (i.e., providing a tube with both corrugations and longitudinally extending supports, as in Stalter) to improve a similar device (i.e., the tube of Bigonzi-Jaker, formed from flexible materials and having longitudinally extending supports) in the same way (e.g., enabling the hose to bend transversely to the supports without kinking, while also ensuring the tube does not expand or contract axially, as may be undesirable in certain applications).
Regarding the limitation wherein the at least one longitudinally extending support is configured for “facilitating collapsing of the first component into the second component”, as shown in figs. 6 & 6a of Bigonzi-Jaker, the supports are formed as longitudinally extending, diametrically opposed sealed edges between the two components. While these would provide longitudinal support, and stiffen the tube to bending in the plane of the sealed edges, they would not be expected to prevent a user from collapsing the tube portion of the first component into the tube portion of the second component in a direction transverse to the supports. The supports taught by Stalter are similarly configured, preventing bending / stretching in the plane of the supports but permitting bending transverse to the support plane. As such, the tube of Bigonzi-Jaker, even when modified as above, is reasonably seen as reading on the limitation wherein the at least one longitudinally extending support is “configured for facilitating collapsing of the first component into the second component”, at least in the same manner as applicant’s disclosed longitudinally extending supports.
Examination Note: see also relevant discussion presented later for claim 5 regarding the “storage” and “use” configurations.
Regarding claim 2, the tube of Bigonzi-Jaker, as modified in view of Stalter above so as to comprise a plurality of corrugations in the longitudinal direction formed along the length of the first and second components, and such that the longitudinally extending supports formed along the length of the first and second components are configured to prevent stretching of the first and second components in the longitudinal direction, would further read on or otherwise render obvious a tube (i.e., as above, tube 80 as in figs. 6 & 6A of Bigonzi-Jaker, having corrugations as in Stalter, etc.) comprising:
a first component (i.e., first membrane 77, forming one half of the tube body) and a second component (i.e., second membrane 78, forming the other half of the tube body), the tube having a first end (82), a second end (84), and a first length of the tube extending along the first component and the second component from the first end to the second end (i.e., the linear length of the tube);
a material constituting the lumen of the tube (i.e., the curved portions of first and second components 77 & 78 forming the tube body / lumen; which, when modified, would comprise corrugations as taught by Stalter) and having a second length (i.e., a length as measured along the contours of the corrugations); and
at least one longitudinal extending support formed along the length of the first and second components and configured for preventing stretching of the first and second components in the longitudinal direction (i.e., 86 & 88 of Bigonzi-Jaker; corresponding to longitudinally extending supports 16 of Stalter) and facilitating collapsing of the first component into the second component (see discussion provided for claim 1 above, not repeated for brevity), the support having a length corresponding to the first length that is shorter than the second length (i.e., the support would have the first length corresponding to the simple linear length of the tube, which would be shorter than the second length, as measured along the contours of the corrugations).
Regarding claim 3, the tube of Bigonzi-Jaker, as modified above, reads on the additional limitation wherein the at least one longitudinally extending support includes two longitudinally extending supports (i.e., 86 & 88 of Bigonzi-Jaker; corresponding to the two longitudinally extending supports 16 of Stalter).
Regarding claim 4, Bigonzi-Jaker discloses the additional limitation wherein a wall of the tube is made of a polymer material (e.g., modified PTFE films / membranes; see abstract, col. 5, lines 27-65, etc.).
Regarding the limitation wherein the polymer material has a thickness in a range from 10-90 micrometers, Bigonzi-Jaker discloses that, for most applications, the walls of such a tube “preferably have a thickness less than about 0.010 in. [254 micrometers], and more preferably less than about 0.0025 in [63.5 micrometers], and still more preferably less than about 0.001 inch [25.4 micrometers]” (col. 9, lines 22-26). As can be seen, Bigonzi-Jaker’s broadest range (<254 micrometers) encompasses the claimed range, while the more preferred ranges (<63.5 micrometers & < 25.4 micrometers) overlap the claimed range.
Moreover, in other instances, Bigonzi-Jaker discloses that such polymer materials, generally, may have a film thickness of about 0.001 to about 0.002 inches (about 25.4 to about 50.8 micrometers)(see col. 7, lines 8-11 & published claim 5), which lies within the claimed range.
As set forth in MPEP § § 2144.05(I), in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
Regarding claim 5, the tube of Bigonzi-Jaker, as modified above, is seen as reading on the additional limitation wherein the tube has a storage configuration in which an inner lumen of the tube is substantially closed along the length of the tube and wherein the tube has a use configuration in which the inner lumen is open to allow flow of liquid through the lumen.
First, as set forth in MPEP § 2114(II), "[A]pparatus 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) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
In this case, while the cited references do not explicitly disclose the “storage” configuration, as explained below, the resulting combination is nevertheless seen as having corresponding structure capable of performing the claimed function. See MPEP § 2114(I).
In particular, while such a function is not explicitly disclosed by Bigonzi-Jaker, the structure of the tube resulting from the combination of Bigonzi-Jaker and Stalter is seen as being capable of adopting a storage configuration in which an inner lumen of the tube is substantially closed along the length of the tube and a use configuration in which the inner lumen is open to allow flow of liquid through the lumen.
The use configuration corresponds to the original configurations as shown in Bigonzi-Jaker and Stalter: the lumen is open and the corrugations (in Stalter) extend radially outward.
With respect to the storage configuration, it is noted that the tube of Bigonzi-Jaker is formed from two sheets of relatively thin, flexible polymeric film, which are heat-sealed at the longitudinal edges (i.e., forming the longitudinal supports). At certain thicknesses, Bigonzi-Jaker suggests that the material may be “soft and supple” (col. 7, lines 11-12).
Meanwhile, as can be seen from figures 1 & 3 of Stalter, the corrugations are laterally symmetric about the longitudinal supports; that is, the corrugation peaks on one side of the supports are aligned with the corrugation peaks on the other side (i.e., in figs. 1 & 3 of Stalter, the peaks above the support are aligned with the peaks below the support).
When the thin film tube of Bigonzi-Jaker is modified to comprise such aligned corrugations, the resulting configuration is such that one could reasonably press down upon the corrugation peaks formed in one of the polymer film sheets, collapsing and inverting them such that they extend inward, closing the lumen and nesting within the corresponding corrugation peak of the other polymer film sheet, achieving the claimed “storage” configuration.
Regarding claim 6, Bigonzi-Jaker discloses the additional limitation wherein the at least one longitudinally extending support (86, 88) is made by welding the tube in the longitudinal direction (see col. 9, lines 32-38: “heat sealed along two of their respective edges, to form tube 80 having…respective sealed edges 86, 88”; see also col. 8, line 57 – col. 9, line 5: “…the sealed edges…can be formed in any conventional manner, for example through use of heat-sealing bars, sonic welding, use of a heat gun, a sintering oven, a thermal impulse,…or any other now known…combination of heat and pressure…. The dwell time and pressure are dependent upon the film thickness as well as whether a tack weld or fusion weld is desired.”).
Regarding claim 7, the tube of Bigonzi-Jaker, as modified above to include corrugations as in Stalter, reads on or otherwise renders obvious the additional limitations wherein a first width of the tube in the transverse direction (i.e., the width of the tube at the peaks of the corrugations) is larger than a second width of the tube in the transverse direction (i.e., the width of the tube at the valleys of the corrugations), wherein the first and second widths alternate in a longitudinal direction (see figs. 1 & 3 of Stalter).
Regarding claim 14, the tube of Bigonzi-Jaker, as modified above, reads on or otherwise renders obvious the additional limitations wherein the width of the tube is measured transverse across an outside diameter of a wall of the tube, with the wall of the tube having an inside diameter that defines a lumen of the tube (i.e., corresponding to the inside diameter as shown in the cross-sectional fig. 3 of Stalter), and the lumen of the tube has corrugations in the longitudinal direction such that the inside diameter of the lumen alternates longitudinally between a first diameter (i.e., the inside diameter at the valleys of the corrugations) to a second diameter (i.e., the inside diameter at the peaks of the corrugations) larger than the first diameter (as shown in fig. 3 of Stalter).
Regarding claim 15, Bigonzi-Jaker discloses the additional limitation wherein the at least one longitudinally extending support (86, 88) comprises welded plastic (e.g., heat-sealed or otherwise welded modified PTFE film; see citations in rejections of claim 4 & 6 above) formed longitudinally along the outside diameter of the wall of the tube (see figs. 6 & 6A of Bigonzi-Jaker).
Regarding claim 16, the tube of Bigonzi-Jaker, as modified above, reads on or otherwise renders obvious the additional limitations wherein the corrugations in the longitudinal direction of the lumen of the tube (i.e., as taught by Stalter) are adapted to expand under extension and abut under compression such that the lumen of the tube is not restricted when the tube is bent.
In particular, as would be understood by those skilled in the art, when the tube of Bigonzi-Jaker is modified so as to include corrugations of the type shown by Stalter, bending the tube transversely to the plane of the supports would place corrugations on the inside radius of the bend into compression, whereby they would approach one another until they abut, and would place corrugations on the outside radius of the bend into tension, whereby they would expand / extend. As a result, the central lumen does not kink and does not become occluded during normal bending action.
Regarding claim 17, the tube of Bigonzi-Jaker, as modified above, reads on or otherwise renders obvious the additional limitations wherein the first component (i.e., first membrane 77 of Bigonzi-Jaker) defines a first set of corrugations (when modified in view of Stalter as above) in the plurality of corrugations, the second component (i.e., second membrane 78 of Bigonzi-Jaker) defines a second set of corrugations (i.e., when modified in view of Stalter as above) in the plurality of corrugations that are on an opposite side of the tube from the first set of corrugations (i.e., the first and second components, when corrugated, generally corresponding to the first and second corrugated portions of Stalter as described for claim 1), and the collapsing of the first component into the second component is facilitated by collapsing the first set of corrugations into the second set of corrugations (see relevant discussion provided for the rejection of claim 5 above, not repeated for brevity).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Bigonzi-Jaker in view of Stalter as applied to claim 1 above, and further in view of Gobel (US 2019/0358390 A1).
Regarding claim 8, Bigonzi-Jaker discloses that the tube may “have broad applications” from medicine to industry (col. 9, lines 14-17; see also abstract), however, Bigonzi-Jaker does not explicitly disclose the additional limitations wherein the first end of the tube comprises a first connector that is attachable to a reservoir bag and the second end of the tube comprises a second connector that is attachable to an anal probe of an anal irrigation system.
Gobel teaches (e.g., figs 1-4) an anal irrigation system (1; see abstract) comprising a film tube (4) having a first end with a first connector (i.e., at 6 in fig. 1; 11 in fig. 3, or “connector element” 17 in fig. 5b; etc.) attachable to a reservoir bag (5) and a second end with a second connector (i.e., see connection to probe 2 in fig. 3; alternate embodiment in fig. 6 showing tube 105 connected to probe incl. 101, 102, etc.) attachable to an anal probe (i.e., 2 in figs 1 & 3; 101 / 102 in fig. 6; etc.).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the tube of Bigonzi-Jaker (as otherwise modified above) such that the first end of the tube comprises a first connector that is attachable to a reservoir bag and the second end of the tube comprises a second connector that is attachable to an anal probe of an anal irrigation system, in view of the teachings of Gobel, as the simple substitution of one known element (i.e., the conventional film tube in the system of Gobel) for another (i.e., the corrugated film tube of Bigonzi-Jaker in view of Stalter) to obtain predictable results (i.e., providing a tube with improved kink-resistance to the system of Gobel, etc.); or otherwise as a combination of known prior art elements (i.e., the corrugated film tube of Bigonzi-Jaker in view of Stalter; and the irrigation system of Gobel) according to known methods (i.e., as in Gobel, a film tube may be provided with suitable end connectors to connect a probe to a reservoir bag of an irrigation system) to yield predictable results (i.e., as above, improving the system of Gobel by providing the film tube with increased kink resistance, etc.).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Bigonzi-Jaker in view of Stalter as applied to claim 1 above, and further in view of McMenamin et al. (US 2019/0321587 A1; hereafter McMenamin).
Regarding claim 9, Bigonzi-Jaker discloses that the tube may “have broad applications” from medicine to industry (col. 9, lines 14-17; see also abstract), however, Bigonzi-Jaker does not explicitly disclose the additional limitations wherein the first end of the tube comprises a first connector that is attachable to a reservoir bag and the second end of the tube comprises a second connector that is attachable to a urinary catheter.
McMenamin teaches (various embodiments in figs. 1-17) a urinary catheter assembly (10) comprising a tube (16, 16’, 16”) with a first end (23) comprising a first connector that is attachable to a reservoir bag (14)(see para. 35: end 23 of tube 16 may be connected to port 22 of bag 14 by various methods, including a barb connector similar to connector 30 used for the connecting the second end to the catheter), and a second end comprising a second connector (i.e., connector 30 in figs. 3-6) that is attachable to a urinary catheter (12).
McMenamin further teaches (para. 38) that the tube may be provided in a variety of forms, including a transparent tube (16) or a transparent sleeve (16’) which can be flat when no flow is present but opens (bulges) in the presence of fluid.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the tube of Bigonzi-Jaker (as otherwise modified above) such that the first end of the tube comprises a first connector that is attachable to a reservoir bag and the second end of the tube comprises a second connector that is attachable to a urinary catheter, in view of the teachings of McMenamin, as the simple substitution of one known element (e.g., the conventional round tube or film tube in the system of McMenamin) for another (i.e., the corrugated film tube of Bigonzi-Jaker in view of Stalter) to obtain predictable results (e.g., providing a tube solution for the catheter system of McMenamin which retains the benefits of a film tube [e.g., using less material / more economical vs conventional round tube for disposable applications], but with improved kink-resistance relative to such conventional film tubes, etc.); or otherwise as a combination of known prior art elements (i.e., the corrugated film tube of Bigonzi-Jaker in view of Stalter; and the catheter system of McMenamin) according to known methods (i.e., as in McMenamin, a tube, such as a round tube or a film tube, may be provided with suitable end connectors to connect a reservoir bag to a urinary catheter) to yield predictable results (i.e., as above, improving the system of McMenamin by providing a film-type tube with increased kink resistance, etc.).
Response to Arguments
Applicant's arguments filed 13 May 2026 have been fully considered.
Applicant’s amendments to the claims have overcome the rejections under 35 U.S.C. 102 set forth in the previous action.
With respect to the rejections under 35 U.S.C. 103, applicant’s arguments are not found to be persuasive, for the reasons detailed below. The rejections under 35 U.S.C. 103 have been amended in this action, as necessitated by applicant’s amendments.
Applicant argues that “the purpose of Stalter’s non-kinkable hose is to prevent the collapse of the hose due to uneven thickness”. In context, Stalter discloses the hose as intended to prevent kinking, i.e., avoiding collapse during bending of the hose along its length. Stalter does not appear to specifically address a scenario where the corrugations of one side are pressed transversely down to collapse into the corrugations of the other side, however, at least in the first embodiment wherein only two diametrically opposed supports are provided, it does not appear the supports would prevent such a collapse.
It is noted that preventing kinking during bending and permitting transverse collapse are not mutually exclusive features. Indeed, applicant’s own disclosed tube, while transversely collapsable, is also intended to prevent kinking during bending in a substantially similar manner as Stalter (see, e.g., para. 12 of applicant’s published application).
With respect to applicant’s argument that the “tube 80” of Bigonzi-Jaker must be “flexible enough to deform in response to another tube…being positioned inside it”, this argument is not found to be persuasive. The portions of Bigonzi-Jaker cited by applicant refer to optional features and/or alternative embodiments (e.g., fig. 9) which were not used as the basis of the rejection (e.g., figs. 6 & 6a).
Applicant’s argument that “if the tube 80 were provided with the “fin 16” of Stalter…the tube 80…would lose its flexibility and therefore become incapable of receiving the other tube 90…” is also not found to be persuasive. The ability to receive another tube (as in fig. 9) is not a required feature of every embodiment, nor a feature of the embodiment relied upon in the rejection. Indeed, the embodiment of Bigonzi-Jaker shown in figs. 6 & 6a already has a similar pair of corresponding longitudinally extending support features (86, 88), contradicting applicant’s argument that providing such a feature would render the tube of Bigonzi-Jaker unsatisfactory for its intended purpose.
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.
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/Richard K. Durden/Examiner, Art Unit 3753
/KENNETH RINEHART/Supervisory Patent Examiner, Art Unit 3753
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