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 amendment filed on March 6th, 2024 has been entered. Claims 1-7, 9-10, 12-13, and 15-23 are currently pending. Claims 8, 11, and 14 have been cancelled. Claims 1,4-7,9-10,12-13, 15-16, and 18-20 have been amended. Claims 21-23 have been withdrawn from consideration in response to preliminary election for the restriction requirement detailed below.
Election/Restriction
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, claim(s) 1-7, 9-10, 12-13, and 15-20, drawn to a fluid collection assembly.
Group II, claim(s) 21-23, drawn to a method of using a fluid collection assembly.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Groups I and II lack unity of invention because even though the inventions of these groups require the technical feature of a fluid collection assembly having fluid impermeable layer defining an opening, a chamber, and a fluid outlet, and at least one porous material disposed in the chamber, the at least one porous material including at least one vertical nonwoven material, the at least one vertical nonwoven material including a plurality of fibers, wherein the vertical nonwoven material is folded, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Sanchez et al. (U.S. Publication 2019/0142624) in view of Stern (U.S. Patent No. 4,681,577) (see rejection of claim 1 and 20 below for details of Sanchez in view of Stern suggesting the technical feature). During a telephone conversation with Joshua Hoggard on March 3rd, 2026 a provisional election was made without traverse to prosecute the invention of Group I, claims 1-7, 9-10, 12-13, and 15-20. Affirmation of this election must be made by applicant in replying to this Office action. Claims 21-23 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
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.
Claims 1-7, 9-10, 12-13, and 15-23 are 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.
The term “vertical” in claims 1, 2, 4-7, 9-10, 12-13, 15-16, 18, and 20-21 is a relative term which renders the claim indefinite. The term “vertical” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The term “vertical” can be reasonable interpreted to mean at a right angle to a horizontal plane or straight up and down by one of ordinary skill in the art, however, both of these interpretations require a relation to either a defined plane at which a right angle is established or a defined “up and down”, neither of which are defined by the current claim language. As there is no reference to what structure the nonwoven material is “vertical” to one of ordinary skill in the art would not be capable of ascertaining the boundary at which the limitation of “vertical” defines the nonwoven material to, and as such claims 1. 20, and 21 are considered indefinite and rejected herein with claims 2-7, 9-10, 12-13, 15-19, and 22-23 being rejected as based on a rejected claim.
For the purpose of examination, the claim term vertical is being interpreted to mean that the material contains portion of a surface of the material that are oriented vertically, or at a 90 degree orientation, such as to exhibit a radial extension, as denoted b T in Fig. 1D, in relation to the longitudinal axis denoted by element 116.
The term “generally aligned” in claims 1, 13 and 20 is a relative term which renders the claim indefinite. The term “generally aligned” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. While the specification attempts to apply a standard to ascertain the term of “generally aligned” in ¶0037 it would be unclear to one of ordinary skill in the art whether the claim terminology of “generally aligned” consists of at least about 70% of fibers, at least about 80% of fibers, at least about 90% of fibers parallel to each other by plus or minus 30 degrees, plus or minus 20 degrees, plus or minus 10 degrees, or plus or minus 5 degrees, as applicant has simply defined the term as “the fibers are ”generally aligned” when a certain percentage of the fibers are substantially parallel to each other” but then goes on to provide different percentages for which the “certain percentage” and different degrees for which “substantially parallel” that defines “generally aligned” is to be obtained. The applicant has not provided examples or teachings in the specification of how one would measure the degree to which a certain percentage of the fibers are parallel to one another as it does not specify whether the degree is an average variation across the entire fiber length, whether the degree is measured in multiple axis and then the deviation across all axis measured and then averaged to come to an average degree, or whether one of ordinary skill in the art would compare one fiber to all other fibers etc. as for example if the longitudinal extension of a fiber is utilized as a standard for determining degree of parallel and there are 3 dimensional axes A,B, and C such that the axis are perpendicular to one another to define the three dimensional plane of existence upon which these fibers exist , and we have fiber A-D defined in the three dimensional space as below with the midpoint of the longitudinal extension of the fiber occurring substantially at the intersection of axis A,B, and C (both fibers cannot occupy exact space of intersection but this is stated to say that the fibers abut each other as closely as possible with their thickness at this point)
Fiber
Degree from Axis A in plane defined by Axis A and B
Degree from Axis A in plane defined by A and C
A
0
0
B
30
15
C
-30
0
D
0
31
In this example:
Fibers A and B are within the 30 degree margin in both planes of each other
Fibers A and C are within the 30 degree margin in both planes of each other
Fibers A and D are within 30 degrees in plane AB
Fibers B and C are within 30 degrees in plane AC
Fibers B and D are within 30 degrees in both planes
Fibers C and D are within 30 degrees in plane AB
With the method of ascertaining the degree of whether fibers are generally aligned provided by the specification one of ordinary skill would not be able to ascertain whether the above fibers fit the requirement of 70% of fibers being parallel to each other by 30 degrees as applicant has not provided a sufficient standard as to how to arrive at the comparison of parallel between fibers in order to determine the percentage. Fiber A is parallel to fibers B and C in both planes with Fibers B and D being parallel in both planes, but fibers B and C, C and D, and A and D, are not parallel in in both planes. One of ordinary skill would not be apprised based on the application specification as to whether fibers A-D are considered substantially parallel to each as the fibers present individual relationships to each fiber and the applicant has not provided sufficient detail as to how this situation determines whether a fiber is considered in the percentage of aligned fibers. As such it is unclear to one of ordinary skill in the art in the current claim what standard is encompassed by the current claim language and as such the term is considered to be indefinite.
Furthermore, the percentages provided state the term “at least about” but do not provide indication as to what range of specific percentage the term about covers.
For the purpose of examination, the term “generally aligned” is being determined as the general orientation of the fibers of the web imparted by the carding process of manufacture as detailed in ¶0041 of the applicant’s specification.
Claim 3 recites the limitation "the conduit" in line 2. There is insufficient antecedent basis for this limitation in the claim.
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) 1-2, 4-5, 7, 12-13, 15-18, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sanchez et al. (U.S. Publication 2019/0142624) in view of Stern (U.S. Patent No. 4,681,577) as evidenced by Stumpf (U.S. Patent No. 3,720,554).
Regarding claims 1 and 20, Sanchez discloses a fluid collection system (Fig. 1 utilizing the embodiment suction assembly 2602), comprising: a fluid collection assembly 2602 including:
a fluid impermeable layer 2604 at least defining:
a chamber (space defined interior to impermeable casing);
at least one opening 2604A; and
a fluid outlet 2620;
at least one porous (¶0160 sufficient porosity) material 2640 disposed in the chamber (Fig. 46 shows it disposed in chamber), the porous material being permeable and having wicking properties, a high absorptive rate, and a high permeation rate such as to wick fluid away from the skin of a user such that dampness of the skin is lessened and to prevent fluid from leaking or flowing beyond the assembly (¶0161) and made from polyester, polyester fleece and/or nylon (¶0162);
a fluid storage container 160; and
a vacuum source 170;
wherein the chamber of the fluid collection assembly, the fluid storage container, and the vacuum source are in fluid communication with each other so that, when one or more bodily fluids are present in the chamber, a suction provided from the vacuum source to the chamber of the fluid collection assembly removes the one or more bodily fluids from the chamber and deposits the bodily fluids in the fluid storage container (¶0067 assembly arranged such that fluid flow through support into reservoir out of outlet…discharge line fluidically coupled to external receptacle...receptacle in fluid communication with vacuum source; ¶0075 vacuum source applies sufficient suction to capture all urine voided by user).
Sanchez does not expressly disclose the at least one porous material including at least one vertical nonwoven material, the at least one vertical nonwoven material including a plurality of fibers that are generally aligned, wherein the vertical nonwoven material is folded.
However, Stern, in the same field of endeavor of collection of fluid excreted from a user, teaches a porous material (first superstructure in front portion 16, 52 corrugated web, Col. 13 lines 22, web inherently includes pores between fibers and capability of retaining liquid and thus being porous disclosed by wettability Col. 9 lines 10-18 wettability of individual fibers) including a vertical (Fig. 1 shows vertical orientation of portions of corrugation at the indication element 15 as further depicted in Fig. 3) nonwoven (Col. 4 line 5 nonwoven) material (Col 8 lines 35-42 polyester fiber first layer, Col 9. Lines 23-31 hydrophilic fiber second layer) including a plurality of fibers (Col. 8 lines 35-42 polyester fibers, Col. 9 lines 23-31 fibrous) that are generally aligned (Col. 8 line 1 carding, see evidentiary reference of Stumpf below), wherein the vertical nonwoven material is folded (Col. 8 line 16 corrugation or transverse folding) for the purpose of quickly accepting and retaining a relatively large quantity of liquid while not leaking or spilling over by providing a sufficient void volume (Col. 10 lines 8-15) that is provided by the spaces between the material created by the folding (Col 10 lines 64-68 folds of corrugated web constitute void volume portion of superstructure) with sufficient void volume being necessary to hold a normal liquid void and receive the liquid rapidly enough to prevent run off (Col. 10 lines 8-15, provide sufficient void volume to hold a normal liquid void and impact capacity to receive the liquid rapidly enough to prevent run off; Col. 3 lines 49-53 superstructure is non-collapsible when wet and maintains a void volume) as well as provides sufficient impact capacity (Abstract) which is necessary to immediately entrap liquid upon initial contact (Col. 9 lines 49-66, sponge not satisfactory as does not provide adequate impact capacity).
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 permeable support 2640 of Sanchez that performs the function of receiving urine voided from a patient and moving liquid away from the patient for the porous two layered corrugated vertical material of Stern since these elements perform the same function of receiving urine excreted from a user and moving liquid away from the point of reception. Simply substituting one fluid receiving material means for another would yield the predictable result of allowing a(n) user excretion receiving device to receive fluid excretions and transport them away from the user. See MPEP 2143.
Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the above substitution for the purpose of providing a material that has sufficient void volume and impact capacity to entrap liquid upon initial contact and prevent run off (Col. 10 lines 8-15, Col. 9 lines 49-66 as listed above of Stern).
Examiner notes that while Stern does not expressly state the fibers of the nonwoven being “generally aligned” the nonwoven web disclosed by Stern is a carded nonwoven web and fibers being generally aligned is inherent to a fibrous web formed by the carding process. Evidence for a carded web having the characteristic of generally aligned is provided in the reference Stumpf (U.S. Patent No. 3,720,554) in Col. 3 lines 2-7 which states that “In such a carded web 50 to 70 percent of the fibers may be oriented substantially parallel with the machine direction”. As such the material of Stern is considered to have fibers that are generally aligned and the combination of Sanchez in view of Stern is seen to have rendered the current claim limitations obvious to one of ordinary skill in the art.
Regarding claim 2, Sanchez in view of Stern suggest the fluid collection assembly of claim 1. Sanchez further discloses the at least one vertical nonwoven material defining a bore configured to receive a conduit (¶0162 sheet rolled into a tubular shape, ¶0121 defines channel, channel can be shaped and configured to receive outlet tube).
Regarding claim 4, Sanchez in view of Stern suggest the fluid collection assembly of claim 1. Stern further suggests the at least one vertical nonwoven material being hydrophilic (Col 9. Lines 23-31 hydrophilic fiber second layer).
Regarding claim 5, Sanchez in view of Stern suggest the fluid collection assembly of claim 1. Stern further suggests the at least one vertical material including polyester (Col. 8 lines 35-42 polyester fibers.
Regarding claim 7, Sanchez in view of Stern suggest the fluid collection assembly of claim 1. Stern further suggest the vertical nonwoven material exhibiting a thickness from about 6.35 mm to 76.2 mm or more preferably 12.7 mm to 38.1 mm (Col. 8 lines 20-21 web thickness will be from about ¼ to about 3”, preferably from about ½ to about 1 ½” ).
While Stern does not expressly suggest the range of 1.5 mm to about 20 mm, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the thickness of Sanchez in view of Stern, from between 1.5 mm to 20 mm as applicant appears to have placed no criticality on the claimed range (¶0030 the vertical nonwoven material may be selected to exhibit a thickness that is greater than about 1 mm, such as in ranges of 1mm to…about 30 mm) and since it has been held that “[i]n 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); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). In the instant case, the range claimed lies inside the ranges disclosed in Stern and the device of Sanchez in view of Stern would not operate differently with the claimed range. Furthermore, applicant places no criticality on the ranged claimed, indicating simply that the vertical nonwoven material may be selected to exhibit a thickness that is greater than about 1 mm, such as in ranges of 1mm to…about 30 mm (¶0030 of applicant’s specification).
Regarding claim 12, Sanchez in view of Stern suggest the fluid collection assembly of claim 1. Stern further suggests the vertical nonwoven material including a plurality of folded portions and a plurality of intermediate portions extending between the folded portions (see illustrative diagram of Fig. 5 of Stern below.
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286
786
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Greyscale
Illustrative diagram of Fig. 5 of Stern.
Regarding claim 13, Sanchez in view of Stern suggest the fluid collection assembly of claim 12. Sanchez further discloses the material being rolled into a tubular shape such that it defines a channel into which the outlet tube is placed (¶0162 sheet rolled into a tubular shape, ¶0121 defines channel, channel can be shaped and configured to receive outlet tube) which discloses the material being placed in a circumferential manner around the outlet tube and in relation to the device.
Stern, in the same field of endeavor of collection of fluid excreted from a user, further teaches the folds being oriented within the device such that the folds of the material extend in a longitudinal direction of the device (see Fig. 1 element 15 folds can be seen to be in the length direction of the device) which would have the added benefit of orienting the void volumes present between folds in direction of the greatest dimension of the device to allow for the greatest amount of void space being available for receiving liquid and thus having a greater capacity for liquid reception.
As such it would have been obvious to one of ordinary skill in the art to have oriented the material prior to rolling it such that the folds extending in the longitudinal direction and thus once rolled, as the plurality of fibers are carded and thus generally aligned in a planar arrangement with the surface of the material, have the plurality of fibers of each of the plurality of the folded portions of the at least one vertical nonwoven material be generally aligned circumferentially (as the fibers are carded to be in a planar arrangement, fibers would be generally aligned circumferentially once the material is rolled as the folds would extend longitudinally to the device) and the plurality of fibers of each of the plurality of intermediate portions of the at least one vertical nonwoven material are generally aligned radially (as fibers are carded to be in a planar arrangement, fibers would be generally aligned circumferentially once the material is rolled and placed around the conduit as the folds and subsequent valleys would extend longitudinally to the device making the intermediate sides vertical with respect to the surface of the conduit and thus radially aligned to the conduit).
Regarding claim 15, Sanchez in view of Stern suggest the fluid collection assembly of claim 1. Sanchez in view of Stern further suggests the vertical nonwoven material including a single nonwoven material that extends from a conduit disposed in the chamber to the fluid impermeable layer (Sanchez discloses 2640 being the only material between casing 2650 and conduit 2621 see Fig. 47; Stern suggest the first and second layer particles being air-laid and thus combined into one material before any transvers folding or corrugating takes place Col. 9 lines 41-45).
Regarding claim 16, Sanchez in view of Stern suggest the fluid collection assembly of claim 1. Sanchez in view of Stern suggest the fluid collection assembly of claim 1. Sanchez in view of Stern in the current embodiment do not expressly disclose or suggest the at least one porous material further including at least one additional material disposed on the at least one vertical nonwoven material.
However, Stern in the same field of endeavor of collection of fluid excreted from a user, in a separate embodiment, further teaches providing a facing cover on one side of a vertical nonwoven material 42 (Col. 4 lines 25-40 cover or facing entraps the first superstructure which have been placed in the front portion of the shell; Col. 6 lines 18-30 corrugated web placed with the open corrugations toward the facing surface) for the purpose of covering the open side of the product such that the first superstructure is entrapped within the shell thus allowing the superstructure to remain in position in the device (Col. 4 lines 25-40).
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 porous material of Sanchez in view of Stern to have included an additional facing material disposed on the vertical nonwoven material, as taught by Stern, for the purpose of covering the open side of the product such that the first superstructure is entrapped within the shell thus allowing the superstructure to remain in position in the device (Col. 4 lines 25-40).
Regarding claim 17, Sanchez in view of Stern suggest the fluid collection assembly of claim 1. Sanchez in view of Stern do not expressly disclose or suggest the at least one additional material including at least one gauze.
However, Sanchez, in a different embodiment, in the same field of endeavor of fluid collection devices, teaches a facing material (element 230 placed in contact with patient ¶0093 permeable membrane against or near a urethral opening of a user and disposed on the outer surface of reservoir ¶0093), that includes gauze (¶0094 permeable membrane can include gauze) for the purpose of having a high absorptive rate and permeation rate such that urine can be rapidly wicked and transported through the permeable membrane. (¶0094)
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 facing material as suggested by Stern, to have included gauze for the purpose of having a high absorptive rate and permeation rate such that urine can be rapidly wicked and transported through the permeable membrane (¶0094 of Sanchez).
Furthermore
Furthermore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to have included gauze as the facing material, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding claim 18, Sanchez in view of Stern suggest the fluid collection assembly of claim 1. Sanchez further discloses the at least one vertical material extending across the at least one opening (Fig. 46 shows material 2640 placed in the device such as to extend across the at least one opening.
Claim(s) 3 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sanchez et al. (U.S. Publication 2019/0142624) in view of Stern (U.S. Patent No. 4,681,577) as evidenced by Stumpf (U.S. Patent No. 3,720,554) and Davis et al. (U.S. Publication 2018/0228642).
Regarding claims 3 and 19, Sanchez in view of Stern suggest the fluid collection assembly of claim 1. Sanchez further discloses a conduit 2621 comprising an exterior surface that is at least partially disposed in the chamber (¶0159 assembly otherwise be the same or similar in structure and/or function to any of the embodiments described above; Fig. 32 shows the placement of the conduit 1640 such that the exterior surface is disposed in the chamber formed by 1650). Sanchez in view of Stern do not expressly disclose or suggest a surface (Claim 3) or exterior surface (Claim 19) having a shape memory foil or coating (Claim 3), or a shape memory material (Claim 19) disposed on a portion of a surface (Claim 3) or exterior surface (Claim 19).
However, Davis, in the same field of endeavor of fluid collection devices, teaches providing a conduit 32 passing through a shape memory element 36 such that 36 coats the exterior of conduit 32 (conduit 32 passes through hollow space of each portion of 36 and is thus a shape memory coating ¶0063) for the purpose of maintaining a configuration of the tube once the tube is bent into a particular shape to fit the anatomical curvature of any user ¶0063.
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 device of Sanchez to have included the shape memory coating as taught by Davis for the purpose of maintaining a configuration of the tube once the tube is bent into a particular shape to fit the anatomical curvature of any user ¶0063.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sanchez et al. (U.S. Publication 2019/0142624) in view of Stern (U.S. Patent No. 4,681,577) as evidenced by Stumpf (U.S. Patent No. 3,720,554) and Yamada (U.S. Publication 2017/0340489).
Regarding claim 6, Sanchez in view of Stern suggest the fluid collection assembly of claim 1. Stern further suggests the vertical nonwoven material being made of cellulosic fibers such as rayon, flax, hemp, jute ramie, cotton (Col. 9 lines 32-40), wood pulp fibers, or the like (Col. 9 lines 226-30). However, Stern does not expressly suggest the material including bamboo.
However, Yamada, in the same field of endeavor of user fluid collection (Abstract urine collection garment), discloses a liquid diffusion fiber sheet being made of natural wood pump or bamboo fiber (¶0122 raw material pulp can contain a bleached softwood… examples of a natural fiber that can be used other than pulp include kenaf, bamboo fiber…).
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 cellulosic fibers of Stern that performs the function of providing a material capable of diffusing liquid though it for the bamboo fiber of Yamada since these elements perform the same function of providing a material capable of diffusing liquid through it when formed into a material layer. Simply substituting one fiber material for another would yield the predictable result of allowing a(n) layer to diffuse fluid through it. See MPEP 2143.
Furthermore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to utilize the bamboo fiber of Yamaha instead of the cellulosic fiber of Stern, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claim(s) 9 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sanchez et al. (U.S. Publication 2019/0142624) in view of Stern (U.S. Patent No. 4,681,577) as evidenced by Stumpf (U.S. Patent No. 3,720,554) and further in view of Yang (U.S. Patent No. 5,030,229).
Regarding claims 9 and 10, Sanchez in view of Stern suggest the fluid collection assembly of claim 1. Stern, in the same field of endeavor of collection of fluid excreted from a user, teaches selecting the density of the layers in order to create a significant difference in capillary pressure from the first fibrous layer (Col. 9 lines 19-22) which results in the layer with the overall greater capillary pressure attracting and draining liquids from the lower capillary pressure layer (Col. 8 lines 59-63 small difference in capillary pressure is all that is required for one layer to attract and drain liquid from an adjacent layer; Col. 9 lines 10-18 relative wickability between a first fibrous layer and a second layer is affected by both the relative densities of the layers; Col. 9 lines 23-31 second layer generally comprised of fibers having…narrower capillary radii) as capillary pressure is shown by Stern to be inversely proportion to the capillary radius and thus the density of the fibers (see equation at Col. 8 line 65).
Sanchez in view of Stern do not expressly disclose or suggest the at least one vertical nonwoven material exhibiting a surface density of about 140 g/m2 to about 250 g/m2 or a density of 60 kg/m3 to about 250 kg/m3.
However, Yang in the same field of endeavor of fluid collection devices (Abstract urinary collection pad), discloses a nonwoven fabric (Col. 7 lines 44-64 nonwoven fabric) having a basis weight in the range of 10.13 g/m2 to 169.5 g/m2 (Col. 7 lines 44-64, 0.3 to 5.0 oz. per square yard) and a density of less than 200 kg/m3 (Col 7 lines 44-64, 0.2 grams per cubic centimeter).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have selected a material for the second layer having a basis weight in the range of about 140 g/m2 to about 250 g/m2 or a density of 60 kg/m3 to about 250 kg/m3 since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine experimentation and is not inventive. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05. Stern teaches the necessity to optimize the difference in densities between adjacent layers in order to create a gradient of capillary pressure which has the benefit of allowing excreted liquid to leave the surface rapidly as it is drawn into the subsequent lower layers due to the difference in capillary gradient. Yang teaches the ability to provide nonwoven fabrics for receiving liquid excretions within the basis weights of 10.13 g/m2 to 169.5 g/m2 (Col. 7 lines 44-64, 0.3 to 5.0 oz. per square yard) and with a density of less than 200 kg/m3 (Col 7 lines 44-64, 0.2 grams per cubic centimeter). Since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice (In re Leshin, 125 USPQ 416) and Stern teaches the necessity to select a material based on its density in order to optimize the difference in densities between adjacent layers, it would have been obvious to one of ordinary skill in the art to utilize a material as disclosed by Yang having a basis weight between 10.13 g/m2 to 169.5 g/m2 (Col. 7 lines 44-64 of Yang, 0.3 to 5.0 oz. per square yard)and with a density of less than 200 kg/m3 (Col 7 lines 44-64 of Yang, 0.2 grams per cubic centimeter).
While Yang does not specifically suggest the range of about 140 g/m2 to about 250 g/m2 or a density of 60 kg/m3 to about 250 kg/m3, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the surface density (i.e. basis weight) and density of Sanchez in view of Stern and Yang, from between about 140 g/m2 to about 250 g/m2 or a density of 60 kg/m3 to about 250 kg/m3 respectively, as applicant appears to have placed no criticality on the claimed range (¶0029 porous material may be selected to exhibit a density of about 5 kg/m2/cm…to about 50 kg/m2/cm ; ¶0031 porous material may be selected to exhibit a basis weight of a about 1 gm/m2….to about 600 g/m2) and since it has been held that “[i]n 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); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). In the instant case, Sanchez in view of Stern and Yang would not operate differently with the claimed range and since the materials of the invention are intended to have their basis weights/densities selected in order to define a capillary pressure gradient in order to better pull fluid away from the upper layers into the lower layers. Further, applicant places no criticality on the ranged claimed, indicating simply that the porous material may be selected to exhibit a density of about 5 kg/m2/cm…to about 50 kg/m2/cm and the porous material may be selected to exhibit a basis weight of a about 1 gm/m2….to about 600 g/m2.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Cohen et al. (U.S. Patent No. 5,695,487) discloses a vertical nonwoven material with generally aligned fibers for use in a fluid collection device 600.
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/PETER DANIEL SMITH/Examiner, Art Unit 3781
/PHILIP R WIEST/Primary Examiner, Art Unit 3781