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 Arguments
Applicant's arguments filed 02/25/2026 have been fully considered but they are not persuasive. Applicant argues that Cheng fails to disclose “the inlet width and the inlet thickness are a maximum width and a maximum thickness of the inlet, respectively, when the tube is positioned on a surface with no external forces applied to the inlet and the inlet is not attached to a first device… the outlet width and the outlet thickness are a maximum width and a maximum thickness of the outlet when the tube is positioned on a surface with no external forces applied to the outlet and the outlet is not attached to a second device…the intermediate width and the intermediate thickness are a maximum width and a maximum thickness of the intermediate portion, respectively, when: the tube is positioned on a surface with no external forces applied to the inlet and outlet and the inlet and the outlet are not attached to the first device and the second device, respectively.” Applicant argues that the “round” cross section of the tubing is present only when connected to a first/second device (connections 60 and 70) and that tube is a flat shape when not attached or connected to anything. While the examiner agree with the argument that the “round” cross section, in view of the amendments where the tube has this shape when not connected to anything, the examiner provides a further rejection under 35 U.S.C regarding the shape of the tubing and the ratio of width and thickness.
The examiner would further like to note, that as written, the limitations read broadly. Specifically with regard to the limitation where “the inlet width and the inlet thickness are a maximum width and a maximum thickness of the inlet… when the tube is positioned on a surface with not external forces applied to eh inlet and the inlet is not attached”. This limitation may be interpreted in one of two ways. The more narrow interpretation is that the inlet width and thickness, prior to attachment to any device are the total maximum for the device, meaning the device’s width and thickness do not change upon connection to a device. However, equally applicable is a more broad interpretation in which the “maximum” width and thickness are the dimensions exhibited when the device not connected to anything a connection in which these dimension change is independent of the condition of the tube being not connected to anything. Therefore a tube that does not change in size while not connected is exhibiting its maximum width and thickness while not connected to anything and on a surface. The examiner notes that while the interpretation is broad due to the language, the interpretations is reasonable to one having ordinary skill in the art, and thus the limitations are interpreted as the latter under BRI. Thus the device of Cheng does exhibit its maximum thickness and width when not connected to any device and while on a surface. Although different language is used in claims 19 and 25, the same reasoning applies to said claims.
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 6 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 6 requires that the first piece is at least one of more rigid or thicker than the first piece. As something cannot be thicker or more rigid than itself the claim is unclear. The examiner notes that while said limitation is likely referring to the second piece (where the first piece is more rigid or thicker than the second piece (See instant spec para. 0055), and this is the interpretation used hereafter, appropriate correction is required.
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.
Claim(s) 1-7,10-15,17-19,23,25-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cheng, previously applied in the prior OA, in view of Trachsel US 2019/0350746, hereafter Trachsel.
Regarding claim 1, Cheng discloses
A tube (Fig. 1 tube (10))configured to be connected to a fluid collection assembly (20), the tube comprising: an inlet exhibiting an inlet width and an inlet thickness that are each measured perpendicular to a longitudinal axis of the tube (portion connected to connector (70)), wherein the inlet width is at most about 4 times greater than the inlet thickness (para. 0047, where the thickness to width ratio is from less than 1 to .05, therefore based on an example of dimension that fit the disclosed ratio of .99 thickness to 1 width, the width the width is within the claimed range of “At most 4 times greater than the thickness), wherein the inlet width and the inlet thickness are a maximum width and a maximum thickness of the inlet, respectively, when the tube is positioned on a surface with no external forces applied to the inlet and the inlet is not attached to a first device (the examiner notes that as detailed under the response to arguments, under BRI, the tubing would exhibit this in an untouched state, as the tubing would not change size when not connected to anything thus exhibiting a maximum width and thickness while not connected to and with no external forces applied.); an outlet downstream from the inlet (portion connected to connector 60, opposite end of tubing from the inlet), the outlet exhibiting an outlet width and an outlet thickness that are each measured perpendicular to the longitudinal axis of the tube(para. 0047, where the thickness to width ratio is from less than 1 to .05, therefore based on an example of dimension that fit the disclosed ratio of .99 thickness to 1 width, the width the width is within the claimed range of “At most 4 times greater than the thickness), wherein the outlet width and the outlet thickness are a maximum width and a maximum thickness of the outlet, respectively, when the tube is positioned on a surface with no external forces applied to the inlet and the outlet is not attached to a second device (the examiner notes that as detailed under the response to arguments, under BRI, the tubing would exhibit this in an untouched state, as the tubing would not change size when not connected to anything thus exhibiting a maximum width and thickness while not connected to and with no external forces applied) and an intermediate portion between the inlet and the outlet (tubing area between the inlet and outlet), the intermediate portion exhibiting an intermediate width and an intermediate thickness that are each measured perpendicular to the longitudinal axis of the tube, the intermediate width at least about 5 times greater than the intermediate thickness, wherein the intermediate width and the intermediate thickness are a maximum width and a maximum thickness of the intermediate portion, respectively, when the tube is positioned on a surface with no external forces applied to the outlet; wherein the inlet, the outlet, and the intermediate portion define a conduit extending from the inlet to the outlet (fig. 1, para. 0047). The examiner notes that per paragraph 0047, the conveyance tube (thus the intermediate portion) has a variable thickness to width ratio preferably within the range of .05-.5. The examiner notes that as this is a thickness:width ratio, the thickness would be .05 and the width would be 1. To determine the ratio of the width:thickness, as claimed, the ratio would be inverted and therefore a simple calculation of 1/.05 would be conducted to give 20. (thickness of 1 (.05/.05) = width of 20 (1/.05)). Therefore the intermediate width is 20 times greater than the thickness and thus reads to the claim of at least 5 times greater.
However, there is no indication in the prior art that the tubing is provided with different two thickness to width ratios (one for the inlet/outlet and one for the intermediate portion) at the same time.
As such, the examiner newly relies upon Trachsel. Trachsel teaches a urine flow control device and is thus considered to the claimed invention. Per the abstract, Trachsel’ s device is “generally elongated tubular object that is flexible, extendable, and compressible (abstract). The examiner notes that as seen in figure 1D, tubular object (108) comprises a central body, which, as seen in the figures has a larger dimension(D1, see para. 0016) than either the first end (130, see diameter D7) or the second end (136, see diameter D11). The examiner notes therefore, that as Trachsel teaches a urine collection device where a tube comprising a tubular object in an intermediate section between a top and bottom opening (inlet and outlet), where said intermediate section has a larger diameter (dimensions) than the inlet and outlet, where the device is still flexible (per abstract) it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the intermediate portion of the tube of Cheng to have a different (larger) dimension than the inlet/outlet end. Doing so would merely involve the simple substitution of one known element (generally consistent dimension tubing) for another (tubing with a larger middle section) to obtain predictable results (that being flow of urine and control of the tubing), and as such a prima facie case of obviousness exists.
The examiner notes that previously, under the same rejection, as an intermediate width of 20 times greater than thickness is a suitable dimension for the tubing of Cheng, said dimension would be suitable for the dimension of the combined art references.
Regarding claim 2, Cheng and Trachsel teach
The tube of claim 1, wherein the inlet width is substantially equal to the inlet thickness. The examiner notes that as detailed under the rejection of claim 1, the inlet thickness, per the disclosed ratio may suitably be .999 and the inlet width, per the same ratio of less than 1, may be 1 (therefore .999/1 for the ratio is .999). As such it is interpreted that the width is substantially equal to the thickness.
Regarding claim 3, Cheng and Trachsel teach
The tube of claim 1 further comprising a tapered portion extending from and between the inlet and the intermediate portion, the tapered portion exhibiting at least one of a width or a thickness that varies from the inlet to the intermediate portion. The examiner notes that per the combination of claim 1, where it was found obvious to combine the teachings of the prior art and have a tube in which an intermediate portion was larger in dimensions than an inlet or an outlet, the tubing must have a least a taper to account for the difference in dimensions between the ends and the middle. As the device would exhibit these dimension prior to attachment, the taper would exist when not attached.
Regarding claim 4, Cheng and Trachsel teach
The tube of claim 3, wherein the inlet, the tapered portion, and the intermediate portion exhibit single piece construction. The examiner notes that as the components are part of the same tubing component, it is interpreted as a single piece construction.
Regarding claim 5, Cheng and Trachsel teach
The tube of claim 3, but fails to specifically teach the device further comprising a first piece and a second piece that is distinct from the first piece, the first piece including the inlet and at least a portion of the tapered portion and the second piece including at least a portion of the intermediate portion. The examiner notes that Trachsel as previously applied teaches an intermediate portion with larger dimensions than either end of the tubing. Further, Trachsel teaches that said intermediate portion may have a ribbing (109) that allows for adjustment of said portion to aid in control of urine flow (para. 0014). The examiner notes that as Trachsel was previously combined with Cheng as a matter of simple substation, it would have further been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention, as a matter of simple substitution to provide said intermediate portion with ribs to allow for increased control of the middle portion of the tubing, while still allowing flexibility of the tubing. The examiner notes that upon said combination the non-ribbed portion of the tubing, including the taper, would be a first piece, and the second, ribbed portion, would be a second piece including the intermediate portion.
Regarding claim 6, Cheng and Trachsel teach
The tube of claim 5, but fails to teach specifically wherein the first piece is at least one of more rigid or thicker than the first piece.
The examiner notes that per the rejection of claim 1, it was found that the intermediate portion has a greater dimension than the inlet, where a suitable thickness for the intermediate portion was .05 and a suitable thickness for the inlet portion was .99. As such the first portion would be thicker than the second portion. Should applicant disagree, the examiner provides a further rejection in view of Trachsel.
Trachsel, as previously combined, teaches that the first and second end portion, previously interpreted as the inlet and outlet, may be rigid or can be made of a thicker material than the body (para. 0017). Therefore, as Trachsel teaches that the inlet and outlet of the tubing may suitably be thicker than the body of the device, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to make the inlet portion (first piece) thicker or more rigid than the second piece.
Regarding claim 7, Cheng and Trachsel teach
The tube of claim 1, wherein the outlet width is at most about 4 times greater than the outlet thickness. The examiner notes that as detailed under the rejection of claim 1, the outlet width to thickness ratio is interpreted to be .99:1 and therefore less than the “at most” 4 times greater.
Regarding claim 10, Cheng and Trachsel teach
The tube of claim 1, wherein the intermediate width is at least about 10 times greater than the intermediate thickness. The examiner notes that as detailed under the rejection of claim 1, the width is 20 times greater than the thickness and thus reads to the claimed limitation.
Regarding claim 11, Cheng and Trachsel teach
The tube of claim 1, but fails to teach wherein the intermediate width is at least about 25 times greater than the intermediate thickness. The examiner notes that per the rejection of claim 1, the width was found to be modifiable to be up to 20 times the thickness (para. 0047).
Per MPEP Section 2144.04 IV A In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit 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. Therefore as Cheng teaches a porous channel for wicking fluids, where the ratio of width to thickness may be variable, the only difference between the prior art and the instant application is the ratio of the width to thickness, and the tube of Cheng is understood to function in the same manner if modified to have a larger width, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the pores of Cheng as an obviousness change in size. The examiner further notes that the width being 25 times the thickness per the claim further lacks criticality in that the width is “at least about” 25 times the thickness, where per para. 0034 of the instant specification, about various ratios are seen to be suitable.
Regarding claim 12, Cheng and Trachsel teach
The tube of claim 1, further comprising one or more fluid flow features disposed in the conduit, the one or more fluid flow features defining a plurality of channels through which one or more fluids may flow (para. 0043-0044, para. 0124-0125). Per paragraphs 0043-0044, the tubing may comprise a spacer serving to prevent the tubing from closing. Per paragraph 0044, the spacer may also have the function to wick fluid through the tube. Therefore the spacer is interpreted as a fluid flow feature, due to its ability to wick fluid, and thus control fluid flow. Further, per paragraph 0124-0125, the spacer has a porous internal structure and be made from various materials, including individual bound fibers, mesh materials, and more, such that the material sufficiently allows for capillary wicking action through spacer. Therefore as the spacer is porous to allow fluid to wick through, it is interpreted to have a plurality of channels through which fluids may flow through.
Regarding claim 13, Cheng and Trachsel teach
The tube of claim 12, wherein the one or more fluid flow features a base and a plurality of walls extending from the base, the base and the plurality of walls at least partially defining the plurality of channels. The examiner notes that as detailed under the rejection of claim 12, the spacer comprises a wicking material comprising channels through which capillary action occurs (para. 0124-0125). The examiner notes that said channels extend through the spacer to deliver fluid from the collection interface to a container. The bottom of the spacer is interpreted as a base where the walls (which formed the channels) extend from the base to form the entire spacer, where the base and the walls define all of the interior channels.
Should applicant disagree with this interpretation, the examiner notes that per MPEP Section 2144.04 IV A In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) (The court held that the configuration of the claimed disposable plastic nursing container was 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 container was significant). Therefore as Cheng teaches a porous spacer comprising channels for wicking fluids, where the only difference between the prior art and the instant application is the shape of the spacer, and the spacer of Cheng is understood to function in the same manner if modified to have a defined base with walls extending from the base and forming said channels, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the spacer of Cheng as an obviousness change in shape.
Regarding claim 14, Cheng and Trachsel teach
The tube of claim 12, wherein the one or more fluid flow features includes a plurality of pipes, each of the plurality of pipes defining at least one of the plurality of channels. The examiner notes that as detailed under the rejection of claim 12, the spacer comprises a wicking material comprising channels through which capillary action occurs (para. 0124-0125). The examiner notes that as said channels extend through the spacer to deliver fluid from the collection interface to a container, said channels are interpreted as pipes.
Regarding claim 15, Cheng and Trachsel teach
The tube of claim 12, wherein the one or more fluid flow features includes a porous material defining a plurality of pores, the plurality of pores forming the plurality of channels. The examiner notes that as detailed under the rejection of claim 12, the spacer may be a porous material to wick fluid through the tube (para. 0124-0125).
Regarding claim 17, Cheng and Trachsel teach
The tube of claim 12, wherein at least one of the plurality of channels includes an entrance and an exit downstream from the entrance (flow pathway), but fails to teach wherein a width of the at least one of the plurality of channels decreases along at least a portion of a length thereof in a direction extending from the entrance to the exit. The examiner notes that per para. 0043 the spacer (and thus the plurality of channels) may have a variable width, thickness and material (dimensions are selected) to accommodate the expected flow of urine.
However, per MPEP Section 2144.04 IV A In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) (The court held that the configuration of the claimed disposable plastic nursing container was 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 container was significant). Therefore as Cheng teaches a porous channel for wicking fluids, where the only difference between the prior art and the instant application is the shape of the channels, and the pores of Cheng are understood to function in the same manner if modified to have a decreasing width (as the spacer layer and thus channels are disclosed to be able to be selected based on expected urine flow), it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the channels of Cheng as an obviousness change in shape.
Regarding claim 18, Cheng and Trachsel teach
The tube of claim 1. The examiner notes that per para. 0062, the urine tube is configured to have the capability for limiting the growth of microbial organisms by maintain antibacterial conditions. However it is not disclosed that a disinfectant coating is on at least a portion of a surface defining the conduit that is proximate to the inlet. Per para 0028 Cheng discloses that it is known in the art for flow paths to be treated with suitable antibacterial materials to limit bacteria growth. See also para. 0139. Therefore, as Cheng teaches that the tubing is configured to prevent bacteria growth, and Chen teaches that a method of preventing bacteria growth is known in the art to be treating a surface with suitable antibacterial materials, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to treat the tubing of Cheng with an antibacterial material to prevent said growth. The examiner notes that antibacterial material is interpreted as disinfectant.
Regarding claim 19, Cheng discloses
A fluid collection system (fig. 1), comprising: a fluid collection assembly defining a fluid outlet (20, where the outlet is the portion running from collection interface (20) and connector (70)); a fluid storage container defining a fluid inlet (30, where the inlet is the portion running from container (30) to connector 60); and at least one tube configured to be connected to the fluid collection assembly (tubing (10)), the at least one tube comprising: an inlet (portion of tubing 10, connecting with connector 70)exhibiting an inlet width and an inlet thickness that are each measured perpendicular to a longitudinal axis of the tube, wherein the inlet width is at most about 4 times greater than the inlet thickness (para. 0047, where the thickness to width ratio is from less than 1 to .05, therefore based on an example of dimension that fit the disclosed ratio of .99 thickness to 1 width, the width the width is within the claimed range of “At most 4 times greater than the thickness), wherein the inlet width and the inlet thickness are a maximum width and a maximum thickness of the inlet, respectively, when the tube is positioned on a surface with no external forces applied to the inlet and the inlet is not attached to a first device (the examiner notes that as detailed under the response to arguments, under BRI, the tubing would exhibit this in an untouched state, as the tubing would not change size when not connected to anything thus exhibiting a maximum width and thickness while not connected to and with no external forces applied.); an outlet downstream from the inlet downstream from the inlet (portion of tube (10) connecting to connector 60), the outlet exhibiting an outlet width and an outlet thickness that are each measured perpendicular to the longitudinal axis of the tube (para. 0047, where the thickness to width ratio is from less than 1 to .05, therefore based on an example of dimension that fit the disclosed ratio of .99 thickness to 1 width, the width the width is within the claimed range of “At most 4 times greater than the thickness), wherein the outlet width and the outlet thickness are a maximum width and a maximum thickness of the outlet, respectively, when the tube is positioned on a surface with no external forces applied to the inlet and the outlet is not attached to a second device (the examiner notes that as detailed under the response to arguments, under BRI, the tubing would exhibit this in an untouched state, as the tubing would not change size when not connected to anything thus exhibiting a maximum width and thickness while not connected to and with no external forces applied); and an intermediate portion between the inlet and the outlet (tubing area between the inlet and outlet), the intermediate portion exhibiting an intermediate width and an intermediate thickness that are each measured perpendicular to the longitudinal axis of the tube, the intermediate width at least about 5 times greater than the intermediate thickness, wherein the intermediate width and the intermediate thickness are a maximum width and a maximum thickness of the intermediate portion, respectively, when the tube is positioned on a surface with no external forces applied to the outlet; wherein the inlet, the outlet, and the intermediate portion define a conduit extending from the inlet to the outlet (fig. 1, para. 0047). The examiner notes that per paragraph 0047, the conveyance tube (thus the intermediate portion) has a variable thickness to width ratio preferably within the range of .05-.5. The examiner notes that as this is a thickness:width ratio, the thickness would be .05 and the width would be 1. To determine the ratio of the width:thickness, as claimed, the ratio would be inverted and therefore a simple calculation of 1/.05 would be conducted to give 20. (thickness of 1 (.05/.05) = width of 20 (1/.05)). Therefore the intermediate width is 20 times greater than the thickness and thus reads to the claim of at least 5 times greater.
However, there is no indication in the prior art that the tubing is provided with different two thickness to width ratios (one for the inlet/outlet and one for the intermediate portion) at the same time.
As such, the examiner newly relies upon Trachsel. Trachsel teaches a urine flow control device and is thus considered to the claimed invention. Per the abstract, Trachsel’ s device is “generally elongated tubular object that is flexible, extendable, and compressible (abstract). The examiner notes that as seen in figure 1D, tubular object (108) comprises a central body, which, as seen in the figures has a larger dimension(D1, see para. 0016) than either the first end (130, see diameter D7) or the second end (136, see diameter D11). The examiner notes therefore, that as Trachsel teaches a urine collection device where a tube comprising a tubular object in an intermediate section between a top and bottom opening (inlet and outlet), where said intermediate section has a larger diameter (dimensions) than the inlet and outlet, where the device is still flexible (per abstract) it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the intermediate portion of the tube of Cheng to have a different (larger) dimension than the inlet/outlet end. Doing so would merely involve the simple substitution of one known element (generally consistent dimension tubing) for another (tubing with a larger middle section) to obtain predictable results (that being flow of urine and control of the tubing), and as such a prima facie case of obviousness exists.
The examiner notes that previously, under the same rejection, as an intermediate width of 20 times greater than thickness is a suitable dimension for the tubing of Cheng, said dimension would be suitable for the dimension of the combined art references.
Regarding claim 23, Cheng and Trachsel teach
The fluid collection system of claim 19, further comprising at least one additional tube directly attached to and extending between the fluid outlet of the fluid collection assembly and the inlet of the at least one tube (fig. 9, extension (22)). The examiner notes that as seen in figure 9, an extension interpreted to be a tubing, runs between the outlet of the collection interface (20) and the inlet of the tube (10) (extension connects to connector (70) and thus connects to the inlet of the tube).
Regarding claim 25, Cheng discloses
A method of using a fluid collection system (para. 0055, claim 37, where the device is attached to a patient for use), the method comprising: receiving one or more bodily fluids from a patient with a fluid collection assembly (claim 37 of Cheng where the device is attached and receives urine from a user), the fluid collection assembly including a fluid outlet (20, where the outlet is the portion running from collection interface (20) and connector (70)); flowing the one or more bodily fluids out of the fluid outlet (para. 0040, where a fluid path from the interface through the conveyance tube and to the storage device), into an inlet of a tube (portion of tube 10 connecting to connector 70), through an intermediate portion of the tube (portion of tube between connectors 60 and 70), and out an outlet of the tube (portion of tube 10 connecting to connector 60), wherein: the inlet exhibits an inlet width and an inlet thickness that are each measured perpendicular to a longitudinal axis of the tube, the inlet width at most about 4 times greater than the inlet thickness(para. 0047, where the thickness to width ratio is from less than 1 to .05, therefore based on an example of dimension that fit the disclosed ratio of .99 thickness to 1 width, the width the width is within the claimed range of “At most 4 times greater than the thickness), wherein the inlet width and the inlet thickness are a maximum width and a maximum thickness of the inlet, respectively, when the tube is positioned on a surface with no external forces applied to the inlet and the inlet is not attached to a first device (the examiner notes that as detailed under the response to arguments, under BRI, the tubing would exhibit this in an untouched state, as the tubing would not change size when not connected to anything thus exhibiting a maximum width and thickness while not connected to and with no external forces applied.); an outlet downstream from the inlet downstream from the inlet (portion of tube (10) connecting to connector 60), the outlet exhibiting an outlet width and an outlet thickness that are each measured perpendicular to the longitudinal axis of the tube (para. 0047, where the thickness to width ratio is from less than 1 to .05, therefore based on an example of dimension that fit the disclosed ratio of .99 thickness to 1 width, the width the width is within the claimed range of “At most 4 times greater than the thickness), wherein the outlet width and the outlet thickness are a maximum width and a maximum thickness of the outlet, respectively, when the tube is positioned on a surface with no external forces applied to the inlet and the outlet is not attached to a second device (the examiner notes that as detailed under the response to arguments, under BRI, the tubing would exhibit this in an untouched state, as the tubing would not change size when not connected to anything thus exhibiting a maximum width and thickness while not connected to and with no external forces applied); and the intermediate portion between the inlet and the outlet, the intermediate portion exhibiting an intermediate width and an intermediate thickness that are each measured perpendicular to the longitudinal axis of the tube, the intermediate width at least about 5 times greater than the intermediate thickness, wherein the intermediate width and the intermediate thickness are a maximum width and a maximum thickness of the intermediate portion, respectively, when the tube is positioned on a surface with no external forces applied to the outlet; the inlet, the outlet, and the intermediate portion define a conduit extending from the inlet to the outlet. The examiner notes that per paragraph 0047, the conveyance tube (thus the intermediate portion) has a variable thickness to width ratio preferably within the range of .05-.5. The examiner notes that as this is a thickness:width ratio, the thickness would be .05 and the width would be 1. To determine the ratio of the width:thickness, as claimed, the ratio would be inverted and therefore a simple calculation of 1/.05 would be conducted to give 20. (thickness of 1 (.05/.05) = width of 20 (1/.05)). Therefore the intermediate width is 20 times greater than the thickness and thus reads to the claim of at least 5 times greater.
However, there is no indication in the prior art that the tubing is provided with different two thickness to width ratios (one for the inlet/outlet and one for the intermediate portion) at the same time.
As such, the examiner newly relies upon Trachsel. Trachsel teaches a urine flow control device and is thus considered to the claimed invention. Per the abstract, Trachsel’ s device is “generally elongated tubular object that is flexible, extendable, and compressible (abstract). The examiner notes that as seen in figure 1D, tubular object (108) comprises a central body, which, as seen in the figures has a larger dimension(D1, see para. 0016) than either the first end (130, see diameter D7) or the second end (136, see diameter D11). The examiner notes therefore, that as Trachsel teaches a urine collection device where a tube comprising a tubular object in an intermediate section between a top and bottom opening (inlet and outlet), where said intermediate section has a larger diameter (dimensions) than the inlet and outlet, where the device is still flexible (per abstract) it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the intermediate portion of the tube of Cheng to have a different (larger) dimension than the inlet/outlet end. Doing so would merely involve the simple substitution of one known element (generally consistent dimension tubing) for another (tubing with a larger middle section) to obtain predictable results (that being flow of urine and control of the tubing), and as such a prima facie case of obviousness exists.
The examiner notes that previously, under the same rejection, as an intermediate width of 20 times greater than thickness is a suitable dimension for the tubing of Cheng, said dimension would be suitable for the dimension of the combined art references.
Regarding claim 26, Cheng and Trachsel teach
The method of claim 25, further comprising positioning the tube underneath the patient (figure 2c).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over [Cheng in view of Trachsel and further in view of Wolff et al. US 2002/0087131, hereafter Wolff.
Regarding claim 16, Cheng discloses
The tube of claim 12, but fails to disclose wherein the cross-sectional area of the plurality of channels is at least about 30 mm2 or greater.
However, per MPEP Section 2144.04 IV A In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit 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. Therefore as Cheng teaches a porous channel for wicking fluids, where the only difference between the prior art and the instant application is the dimensions of the pores, and the pores of Cheng are understood to function in the same manner if modified to have a cross sectional area of 30 mm2 or greater, it would have been obvious to modified the pores of Cheng as an obviousness change in size.
However, should applicant contend for any reason, Wolff teaches a urine collection device and is thus considered analogous. Wolff teaches the use of a nylon mesh to allow urine to pass through (interpreted as a wicking component), where the pore size is 3-10mm (para. 0046). As the pore and thus the cross sectional area are interpreted to be a circle, the following calculation was made
A
=
π
r
2
, where 30=
π
r
2
, where 9.5493=r2, where r=3.0902. Therefore a pore with a radius of 3.1 or greater would have a cross-sectional area of at least 30mm2. Therefore as Cheng teaches that both meshes and nylon may be used as the materials for the spacer (Cheng para. 0125), and Wolff teaches that nylon mesh in urine wicking components may have a pore size of 3-10mm (interpreted as 1.5-5mm radii), it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the nylon mesh pore size of Cheng to have pores size 3-10mm, as Wolff teaches that such a configuration is known in the art. Using the above calculation, a radius of 5mm would equate to a cross sectional are of 78.5mm2 and thus within the claimed range of at least 30mm2.
Conclusion
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/MATTHEW WRUBLESKI/Examiner, Art Unit 3781 /ARIANA ZIMBOUSKI/Primary Examiner, Art Unit 3781
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