DETAILED ACTION
This office action is in response to the communication received June 8, 2026.
The amendments of claims 2, 5, 12, and 17-18 as well as the addition of claims 22-25 and the filed IDS are acknowledged.
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 regarding Hu and Strickland, the same arguments provided for both claims 2, 12, and 17, are not persuasive.
Applicant argues that Hu does not disclose a device that is sized and shaped to fit within an intergluteal cleft due to its diaper-shape. In paragraph 81, the dressing is described as being airtight such as to help remove fecal matter, consequently, such a shape that allows for an airtight fit against the skin would allow for it to be sized and shaped to fit within an intergluteal cleft.
Applicant additionally argues that the sponge region of Hu is not a permeable material disposed within an interior region of a fluid impermeable casing that extends across an opening. However, as explained in the previous rejection, the casing, interpreted as the backsheet, surrounds the sponge region, as can be seen in Fig. 20C, creating an area in which the sponge resides with an opening on top of the region allowing for waste to travel, such an opening being filled by the sponge region. Waste travels through the sponge and a sponge’s structure by itself makes it permeable as it is a porous object (see Figs. 20A-20C, par. 81).
Applicant further argues that Hu does not disclose a conduit disposed within the bodily waste collection device, alleging that Hu discloses a diaper-like bodily arrangement where the tubing is fluidly coupled to the sponge rather than being disposed in an enclosed bodily waste collection device having a fluid impermeable casing defining an interior region, a permeable material extending across an opening, and a conduit within that enclosed structure. However, Fig. 20C clearly shows the conduit in the sponge region, as shown below in the annotated drawing. Additionally, applicant’s arguments regarding the parent application are not persuasive, as Hu clearly shows such a conduit.
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Applicant’s arguments regarding Snyder and Hogan are not persuasive.
Applicant argues that Snyder does not disclose the rectal pouch as sized and shaped to fit within the intergluteal, alleging that it merely hangs or is held under the perineal area. However, the bodily waste collection device is interpreted as bodily waste collection device 18, 33 and due to the positioning of rectal ring 34 fitting snugly against the anus, the bodily waste collection device would be sized and shaped to at least partially fit within such a position (see Snyder, col. 4, lines 32-35).
Applicant further argues that a person of ordinary skill in the art would not be motivated to combine the ostomy pouch materials of Hogan with the rectal pouch of Snyder to arrive at a bodily waste collection device sized and shaped to fit within the intergluteal cleft having a permeable material extending across an opening as neither Snyder nor Hogan disclose such a configuration. First of all, the argument regarding the sizing and shaping regarding the intergluteal cleft has been addressed above, as Snyder discloses such sized and shaped configuration. Additionally, in response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In this case, both Hogan and Snyder disclose openings collecting waste from the body, and such motivation of providing easier and more convenient disposition of absorbed fluid matter applies in providing proper motivation.
Applicant additionally argues that tube 36 of Snyder is more analogous to the “fluid impermeable casing” recited in independent claim 2 since the tube 36 defines the opening of the pouch 33 and as such, Snyder does not disclose the drainage tube 37 extends within pouch 33. However, as explained previously, the bodily waste collection device is interpreted as bodily waste collection device 18, 33 as seen in Figures 5-7 of Snyder, with Snyder further disclosing conduit 36. Because applicant points to a possible different interpretation of parts in the device disclosed by Snyder does not make the rejection explained by the Examiner as incorrect. Furthermore, Figure 6 specifically discloses the conduit disposed within the bodily waste collection device, so it is unclear how such a conduit would not extend through the device.
Applicant’s arguments that dependent claims are allowable because dependent claims depend from allowable claims based on arguments addressed above are not persuasive, as explained above.
Applicant argues that filing of a terminal disclaimer is premature and accordingly, the double patenting rejections are maintained below.
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) 2-3, 5-10, and 17-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hu et al. (US 2010/0174250), disclosed in the IDS of February 13, 2024 and further in view of Strickland et al. (US 4,253,461).
Regarding claim 2, Hu discloses a bodily waste collection apparatus (see Figs. 20A-20C), comprising: a sacral pad configured to attach to a wearer over a sacrum of the wearer (see Figs. 20A-20C with position of sacral pad being 2012, 2010 in Fig. 20A and similarly position sacral pad in Figs. 20B-20C, par. 81, air tight seal between dressing 2012 and skin of sacral region or adhesive 2031 and portion surrounding dressing tubing 2014); and a bodily waste collection device (see par. 81, diaper portion including sponge region 2002, tube 2006, and absorbent material 2004 as well as backing layer) extending from a lower portion of the sacral pad (see Figs. 20A-20C), the bodily waste collection device being sized and shaped to at least partially fit within an intergluteal cleft to receive bodily waste from an anus of a wearer (see Figs. 20A-20C, par. 81), the bodily waste collection device including: a fluid casing (see Fig. 20C, backsheet) defining an interior region therein (see Fig. 20C, interior including sponge region 2032) and defining an opening therein (see Fig. 20A, opening to foam/sponge region 2002); a permeable material 2002, 2032 (see par. 81) disposed in the interior region and extending across at least a portion of the opening (see Figs. 20A-20C, par. 81); and a conduit 2034 disposed within the bodily waste collection device (see Figs. 20A-20C, conduit reaches sponge region).
Hu does not disclose the casing being fluid impermeable, though Hu discloses that the device may be worn by a patient similar to a diaper (see par. 81). Strickland discloses a disposable absorbent brief with a backsheet similar to the casing of Hu (see Fig. 20A of Hu and Fig. 1 of Strickland) wherein the backsheet is a flexible moisture-impermeable sheet (see col. 4, lines 60-65). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the casing of Hu be a flexible moisture-impermeable sheet, Strickland disclosing such a sheet acting as a backsheet in the same position as that disclosed by Hu, and this predictably resulting in the diaper shape with a backsheet that would act as a barrier so that waste and moisture going into the sacral and sponge regions would not travel beyond the backsheet.
Regarding claim 3, Hu and Strickland disclose the apparatus of claim 2 and Hu further discloses the bodily waste collection device is sized and shaped to be disposed over an anus of the wearer when the sacral pad is attached to the wearer over the sacrum (see Figs. 20A-20C, par. 81, for the sponge to capture the fecal matter it would be below the anus).
Regarding claim 5, Hu and Strickland disclose the limitations of claim 2 and Hu further discloses the sacral pad includes: padding material in a central region of the sacral pad (see Fig. 20A and 20C, par. 18, central can be any large central portion within entirety of sacral dressing or longitudinal middle of 2032); and an adhesive is disposed around the padding material (see Figs. 20A, 20C; par. 81).
Regarding claim 6, Hu and Strickland disclose the limitations of claim 5, and Hu further discloses the sacral pad includes a backing material where the padding material and adhesive are disposed on a wearing side of the backing material (see Figs. 20A-20C, especially 20C side view, annotated below).
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Regarding claim 7, Hu and Strickland disclose the limitations of claim 6, and Hu further discloses at least some of the bodily collection device is disposed below a plane of the backing material bodily waste collection apparatus is laid flat (see Fig. 20C, see casing and sponge/foam below).
Regarding claim 8, Hu and Strickland disclose the limitations of claim 6, and Hu further discloses wherein at least some of the bodily waste collection device is disposed above a plane of the backing material when the bodily waste collection apparatus is laid flat (see Fig. 20C, absorbent material 2004 is above a plane).
Regarding claim 9, Hu and Strickland disclose the limitations of claim 9, and Hu further discloses the permeable material includes a fluid permeable sheath (see Figs. 20A-20C, area surrounding/covering conduits 2006, 2034) and a fluid permeable base disposed at least partially under the fluid permeable sheath (see Figs. 20C, base being bottom of sponge region 2002, 2032).
Regarding claim 10, Hu and Strickland disclose the limitations of claim 2 and Hu further discloses the conduit extends into the permeable material (see Figs. 20A-20C).
Regarding claim 17, Hu discloses a method for collecting bodily waste (see Figs. 20A-20C), the method comprising: positioning a bodily waste collection apparatus on a wearer (see par. 81), the bodily waste collection apparatus including: a sacral pad configured to attach to a wearer over a sacrum of the wearer (see Figs. 20A-20C with position of sacral pad being 2012, 2010 in Fig. 20A and similarly position sacral pad in Figs. 20B-20C, par. 81, air tight seal between dressing 2012 and skin of sacral region or adhesive 2031 and portion surrounding dressing tubing 2014); and a bodily waste collection device (see par. 81, diaper portion including sponge region 2002, tube 2006, and absorbent material 2004 as well as backing layer) attached to a lower portion of the sacral pad (see Figs. 20A-20C), the bodily waste collection device being sized and shaped to at least partially fit within the intergluteal cleft to receive bodily waste from the anus of a wearer (see Figs. 20A-20C, par. 81), the bodily waste collection device including: a casing (see Fig. 20C, backsheet) defining an interior region therein (see Fig. 20C, interior including sponge region 2032)and defining an opening therein (see Fig. 20A, opening to foam/sponge region 2002); a permeable material 2002, 2032 (see par. 81) disposed in the interior region and extending across at least a portion of the opening (see Figs. 20A-20C); and a conduit 2034 disposed within the bodily waste collection device (see Figs. 20A-20C, conduit reaches sponge region); receiving liquid waste in the bodily waste collection device (see par. 81); and removing at least some of the liquid waste from the bodily waste collection device via the conduit (see par. 81, via vacuum).
Hu does not disclose the casing being fluid impermeable, though Hu discloses that the device may be worn by a patient similar to a diaper (see par. 81). Strickland discloses a disposable absorbent brief with a backsheet similar to the casing of Hu (see Fig. 20A of Hu and Fig. 1 of Strickland) wherein the backsheet is a flexible moisture-impermeable sheet (see col. 4, lines 60-65). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the casing of Hu be a flexible moisture-impermeable sheet, Strickland disclosing such a sheet acting as a backsheet in the same position as that disclosed by Hu, and this predictably resulting in the diaper shape with a backsheet that would act as a barrier so that waste and moisture going into the sacral and sponge regions would not travel beyond the backsheet.
Regarding claim 18, Hu and Strickland disclose the method of claim 17 and Hu further discloses positioning the bodily waste collection apparatus on a wearer includes positioning and attaching the sacral pad to over a sacrum of the wearer (see par. 81).
Regarding claim 19, Hu and Strickland disclose the method of claim 17 and Hu further discloses positioning the bodily waste collection apparatus on a wearer includes disposing the bodily waste collection device under an anus of the wearer (see par. 81).
Claim(s) 2, 4, and 22-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Snyder (US 3,447,536) in view of Hogan (US 5,139,493).
Regarding claim 2, Snyder discloses a bodily waste collection apparatus (see Figs. 5-7), comprising: a sacral pad 15 configured to attach to a wearer over a sacrum of the wearer (see Figs. 5-7); and a bodily waste collection device 18, 33 extending from a lower portion of the sacral pad (see Fig. 7), the bodily waste collection device being sized and shaped to at least partially fit within an intergluteal cleft to receive bodily waste from an anus of a wearer (see Figs. 6-7; col. 4, lines 32-35), the bodily waste collection device including: a fluid impermeable casing 33 defining an interior region therein and defining an opening therein (see Fig. 6, various openings into the collection area of the collection device); and a conduit 36 disposed within the bodily waste collection device (see Fig. 6).
Snyder does not disclose a permeable material disposed in the interior region and extending across at least a portion of the opening.
Hogan discloses an area collecting bodily waste havening an opening (see Fig. 6, either inlet of bodily fluid or see col. 20, lines 61-68, inlet 102 that optionally allows introduction of volume of chemical reagent or reactant to accommodate the desires or needs of the user) covered with absorbent porous material 98 (see Figs. 6) such that usual problems of liquid pressures, surges, sloshing, and the like encountered are eliminated, and provides for an easier and more convenient disposition of the absorbed fluid matter without fear of liquid leakage (see col. 5, lines 3-16). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to similarly add such a porous material as that disclosed by Hogan in a similar manner such that usual problems of liquid pressures, surges, sloshing, and the like encountered are eliminated, and provides for an easier and more convenient disposition of the absorbed fluid matter without fear of liquid leakage. Additionally, one of ordinary skill in the art would also be motivated to add such an inlet for a chemical reagent or reactant in order to accommodate the desires or needs of the user, therefore treating the user.
Regarding claim 4, Snyder and Hogan disclose the limitations of claim 2 and Snyder further discloses the bodily waste collection device is substantially tubular (see Fig. 6) having a substantially cylindrical shape (see Fig. 6).
Regarding claim 22, Snyder and Hogan disclose the bodily waste collection apparatus of claim 2, and Snyder further discloses the bodily waste collection device includes a first end region (see Figs. 5-7, upper portion of 18, 33) and a second end region (see Figs. 5-7, lower portion of 18, 33 that would include mainly a lower portion of 33) opposite the first end region (see Fig. 6), the bodily waste collection device defining a reservoir (see Figs. 5-7, lower portion of 33 in which bodily waste travels) in the interior region at the second end region.
Regarding claim 23, Snyder and Hogan disclose the bodily waste collection apparatus of claim 2, and Snyder further discloses the conduit extends from a portion of the bodily waste collection device opposite the sacral pad (see Figs. 5-7, extends downward while sacral pad extends upward).
Regarding claim 24, Snyder and Hogan disclose the bodily waste collection apparatus of claim 2 and Snyder further discloses a connecting portion connecting the bodily waste collection device to the sacral pad (see Figs. 5-7, part of 18 between ring 34 and sacral pad, the distance allowing the ring over the anus, see col. 4, lines 32-35).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hu in view of Strickland as applied to claim 2 above, and further in view of Constantin (US 2,749,558) and Hogan.
Regarding claim 11, Hu and Strickland disclose the limitations of claim 2 but do not disclose at least one fluid collection device, the at least one fluid collection device including: a fluid impermeable barrier defining a cavity therein; a porous material disposed in the cavity; and an additional conduit disposed in the cavity.
Constantin discloses a defecation relief unit comprising a conduit 38’(see Fig. 9), at least one fluid storage collection device comprising a container 58 configured to hold a fluid (see Fig. 9), the container including a fluid impermeable barrier defining a cavity therein (see Fig. 9, to hold the fluid in the container the container must be fluid impermeable with cavity containing liquid) and having an additional conduit 57 disposed in the cavity (see Fig. 9), and at least one vacuum source 67 fluidly connected to the at least one fluid storage container via the conduit, the at least one vacuum source configured to draw fluid into the at least one fluid storage container from the bodily waste collection device via the conduit (see Fig. 9; col. 5, lines 38-44). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the system further include a fluid collection device configured to hold a fluid such as that disclosed by Constantin that would predictably result in the connection of the vacuum source to the conduit for collection of bodily waste and allow for a place for the waste to be collected.
Hogan discloses a container 54 for bodily waste including a superabsorbent porous material 56 (see Fig. 4; col. 18, lines 1-3) in its cavity such that usual problems of liquid pressures, surges, sloshing, and the like encountered are eliminated, and provides for an easier and more convenient disposition of the absorbed fluid matter without fear of liquid leakage (see col. 5, lines 3-16). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the at least one fluid storage container to include a superabsorbent porous material, as disclosed by Hogan, in order to eliminate the usual problems of liquid pressures, surges, sloshing, and the like, and provide for an easier and more convenient disposition of the absorbed fluid matter without fear of liquid leakage.
Claim(s) 12 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Hu in view of Strickland and further in view of Constantin (US 2,749,558).
Regarding claim 12, Hu discloses a bodily waste collection system comprising a bodily waste collection apparatus (see Figs. 20A-20C), comprising: a sacral pad 2010, 2012 configured to attach to a wearer over a sacrum of the wearer (see par. 81, air tight seal between dressing 2012 and skin of sacral region or adhesive 2031 and portion surrounding dressing tubing 2014); and a bodily waste collection device (see par. 81, diaper portion including sponge region 2002, tube 2006, and absorbent material 2004 as well as backing layer) extending from a lower portion of the sacral pad (see Figs. 20A-20C), the bodily waste collection device being sized and shaped to at least partially fit within the intergluteal cleft to receive bodily waste from the anus of a wearer (see Figs. 20A-20C, par. 81), the bodily waste collection device including: a fluid casing (see Fig. 20C, backsheet) defining an interior region therein (see Fig. 20C, interior including sponge region 2032) and defining an opening therein (see Fig. 20A, opening to foam/sponge region 2002); a permeable material 2002, 2032 (see par. 81) disposed in the interior region and extending across at least a portion of the opening (see Figs. 20A-20C, par. 81); and a conduit 2034 disposed within the bodily waste collection device (see Figs. 20A-20C, conduit reaches sponge region); and at least one vacuum source fluidly connected via the conduit (see par. 81, vacuum tube 2006, 2034), the at least one vacuum source configured to draw fluid via the conduit (see par. 81).
Hu does not disclose the casing being fluid impermeable, though Hu discloses that the device may be worn by a patient similar to a diaper (see par. 81). Strickland discloses a disposable absorbent brief with a backsheet similar to the casing of Hu (see Fig. 20A of Hu and Fig. 1 of Strickland) wherein the backsheet is a flexible moisture-impermeable sheet (see col. 4, lines 60-65). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the casing of Hu be a flexible moisture-impermeable sheet, Strickland disclosing such a sheet acting as a backsheet in the same position as that disclosed by Hu, and this predictably resulting in the diaper shape with a backsheet that would act as a barrier so that waste and moisture going into the sacral and sponge regions would not travel beyond the backsheet.
Neither Hu nor Strickland disclose the bodily waste collection system comprising at least one fluid storage container configured to hold a fluid and the at least one vacuum source fluidly connected to the at least one fluid storage container via the conduit, the at least one vacuum source configured to draw fluid into the at least one fluid storage container from the bodily waste collection device via the conduit.
Constantin discloses a defecation relief unit comprising a conduit 38’(see Fig. 9), at least one fluid storage container 58 configured to hold a fluid (see Fig. 9) and at least one vacuum source 67 fluidly connected to the at least one fluid storage container via the conduit, the at least one vacuum source configured to draw fluid into the at least one fluid storage container from the bodily waste collection device via the conduit (see Fig. 9; col. 5, lines 38-44). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the system further include a fluid storage container configured to hold a fluid such as that disclosed by Constantin that would predictably result in the connection of the vacuum source to the conduit for collection of bodily waste and allow for a place for the waste to be collected.
Regarding claim 16, Hu, Strickland, and Constantin disclose the limitations of claim 12 and Hu further discloses the sacral pad includes: padding material in a central region of the sacral pad (see Fig. 20A and 20C, par. 18, central can be any large central portion within entirety of sacral dressing or longitudinal middle of 2032); and an adhesive is disposed around the padding material (see Figs. 20A, 20C; par. 81).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hu in view of Strickland as applied to claim 17 above, and further in view of Sanidas (US 4,368,733).
Regarding claim 20, Hu and Strickland disclose the limitations of claim 17 but do not specifically disclose positioning the apparatus on a wearer includes disposing the bodily waste collection device at least partially within an intergluteal cleft of the wearer.
Hu discloses using adhesive to attach the device near the anus (see par. 81). Sanidas discloses an adhesive area 32 surrounding an opening 25 in which feces travels away from the user (see Figs. 1-2), with buttocks spread apart to expose the anus, the anal opening is aligned therewith and the adhesive area is pressed flatly against and secured to the anal area (see col. 3, lines 44-53). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the method of Hu and Strickland further include separating the buttocks and pressing adhesive surrounding the opening to the anal area surrounding the anus opening in order to ensure a direct route for the waste to travel to the conduit through which the waste is vacuumed. Consequently, such a positioning would require the bodily waste collection device to at least partially be disposed within an intergluteal cleft of the wearer.
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hu in view of Strickland as applied to claim 17 above, and further in view of Heaton et al. (US 2015/0246164) and Hogan.
Regarding claim 21, Hu and Strickland disclose the limitations of claim 17 but do not disclose the method further comprising positioning a fluid collection device on the wearer, the fluid collection device including: a fluid impermeable barrier defining a cavity therein and an opening therethrough; a porous material disposed in the cavity; and an additional conduit disposed in the cavity; and receiving urine in the fluid collection device.
Heaton discloses a portable medical device system with a fluid container 11 filled where fluid fills to the container via a conduit 5 using vacuum and collects fluids from the body (see Figs. 1a-1b), the container being the type for a bag for bodily waste (see par. 117) and as it collects waste that stays inside a cavity, it is considered a fluid impermeable barrier defining a cavity therein and an opening therethrough. As the fluid container collects fluid and is worn by the body due to its portability, it is considered a fluid collection device positioned on the wearer. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the method further include positioning a fluid collection device on the wearer, the fluid collection device including a fluid impermeable barrier defining a cavity therein and an opening therethrough, as disclosed by Heaton, in order to have a place to collect fluids withdrawn.
Hogan discloses a container 54 for bodily waste including a superabsorbent porous material 56 (see Fig. 4; col. 18, lines 1-3) in its cavity such that usual problems of liquid pressures, surges, sloshing, and the like encountered are eliminated, and provides for an easier and more convenient disposition of the absorbed fluid matter without fear of liquid leakage (see col. 5, lines 3-16). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the at least one fluid storage container to include a superabsorbent porous material, as disclosed by Hogan, in order to eliminate the usual problems of liquid pressures, surges, sloshing, and the like, and provide for an easier and more convenient disposition of the absorbed fluid matter without fear of liquid leakage.
Hu discloses a conduit going into a cavity of the bodily waste collection device(see Figs. 20A-20C), helping with access to inside the device. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have a conduit going into the cavity of the fluid collection device, similar to the configuration of the conduit into the cavity disclosed by Hu, therefore predictably helping with access to inside the cavity and letting fluids deeper into the cavity/container. As the absorbent material 2004 of Hu collects urine (see Figs. 20A-20C, par. 81) and is adjacent the permeable material and the conduit of the bodily waste collection device, the vacuum would also withdraw urine via the conduit and bring the urine into the fluid collection device.
Claim(s) 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Snyder in view of Hogan as applied to claim 22 above, and further in view of Sanidas (US 4,368,733).
Regarding claim 25, Snyder and Hogan disclose the limitations of claim 22 but do not disclose wherein the bodily waste collection device is at least partially rigid around the reservoir to prevent the bodily waste collection device from collapsing.
Sanidas discloses an invalid feces collecting and examination device with a similar funnel-shaped portion for collection of bodily waste (see Fig. 2, col. 3, lines 25-43) to the reservoir of the second end region disclosed by Snyder (see Snyder, Figures 5-7, funnel shape). Sanidas further discloses the funnel shape with struts of suitable semi-rigid plastic or metal to reinforce the funnel shape to reinforce and retain the chute open (see col. 3, lines 25-43). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to include such semi-rigid plastic or metal struts as disclosed by Sanidas in a similar funnel-shaped position in order to reinforce and retain the reservoir in an open position.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 2 and 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3 and 19 of U.S. Patent No. 11,938,054, hereinafter ‘054. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claim 2, claim 3 of ‘054 discloses all limitations required by claim 2.
Regarding claim 17, claim 19 of ‘054 discloses all limitations required by claim 17.
Claims 3, 5-6, 9-16, and 18-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2, 4-8, 10-13, 15, 17-19 and 24 of ‘054 in view of Sanidas.
The following claims of ‘054 disclose the limitations of the following matched up claims of the current application except for the disclosure that the bodily waste collection device is sized and shaped to at least partially fit within the intergluteal cleft:
Application claim
3
5
6
9
10
11
12
‘054 claim
2
4
5
6
7
8
10
Application claim
13
14
15
16
18
19
20
‘054 claim
11
12
13
15
17
18
19
Application claim
21
‘054 claim
24
Independent claims 1, 10, and 16 of ‘054 disclose the device near the anus, and therefore this limitation is included in all their dependent claims. Sanidas discloses an adhesive area 32 surrounding an opening 25 in which feces travels away from the user (see Figs. 1-2), with buttocks spread apart to expose the anus, the anal opening is aligned therewith and the adhesive area is pressed flatly against and secured to the anal area (see col. 3, lines 44-53). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the method of Hu and Strickland further include separating the buttocks and pressing adhesive surrounding the opening to the anal area surrounding the anus opening in order to ensure a direct route for the waste to travel to the conduit. Consequently, such a positioning would require the bodily waste collection device to at least partially be disposed within an intergluteal cleft of the wearer.
Claims 22-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2 of ‘054 in view of Snyder.
Regarding claim 22, claim 2 of ‘054 does not disclose a first end region and a second end region opposite the first end region, the bodily waste collection device defining a reservoir in the interior region at one or more of the first end region or the second end region.
Snyder further discloses the bodily waste collection device includes a first end region (see Figs. 5-7, upper portion of 18, 33) and a second end region (see Figs. 5-7, lower portion of 18, 33 that would include mainly a lower portion of 33) opposite the first end region (see Fig. 6), the bodily waste collection device defining a reservoir (see Figs. 5-7, lower portion of 33 in which bodily waste travels) in the interior region at the second end region. It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to include such regions as disclosed by Snyder in order to predictably result in the required positioning of the sacral region and cleft region that would allow for collection of bodily waste.
Regarding claim 23, claim 2 of ‘054 does not disclose the conduit extends from a portion of the bodily waste collection device opposite the sacral pad.
Snyder further discloses the conduit extends from a portion of the bodily waste collection device opposite the sacral pad (see Figs. 5-7, extends downward while sacral pad extends upward). It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to include such positioning of the conduit as disclosed by Snyder in order to predictably result in the required positioning of the sacral region and cleft region that would allow for collection of bodily waste, and the withdrawal of fluids from the collection of bodily waste.
Regarding claim 24, claim 2 of ‘054 does not disclose a connecting portion connecting the bodily waste collection device to the sacral pad, the connecting portion having a length selected to match anatomical features of the wearer to allow the opening to be positioned over the anus of the wearer.
Snyder further discloses a connecting portion connecting the bodily waste collection device to the sacral pad (see Figs. 5-7, part of 18 between ring 34 and sacral pad, the distance allowing the ring over the anus, see col. 4, lines 32-35). It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to include a connecting portion as disclosed by Snyder in order to predictably result in the required positioning of the sacral region and cleft region that would allow for collection of bodily waste.
Claim 25 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2 of ‘054 in view of Snyder and further in view of Sanidas.
Regarding claim 25, claim 2 of ‘054 and Snyder do not disclose the bodily waste collection device is at least partially rigid around the reservoir to prevent the bodily waste collection device from collapsing.
Sanidas discloses an invalid feces collecting and examination device with a similar funnel-shaped portion for collection of bodily waste (see Fig. 2, col. 3, lines 25-43) to the reservoir of the second end region disclosed by Snyder (see Snyder, Figures 5-7, funnel shape). Sanidas further discloses the funnel shape with struts of suitable semi-rigid plastic or metal to reinforce the funnel shape to reinforce and retain the chute open (see col. 3, lines 25-43). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to include such semi-rigid plastic or metal struts as disclosed by Sanidas in a similar funnel-shaped position in order to reinforce and retain the reservoir in an open position.
Allowable Subject Matter
Claims 13-15 would be allowable if a terminal disclaimer was filed to overcome the rejection(s) under nonstatutory double patenting, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: the closest prior art found is Hu, Strickland, and Constantin, which do not disclose the required fluid collection device as claimed in claim 13. While Godinez et al. (US 2021/0393433) discloses a fluid collection device 31 coupled to a fluid storage container via an additional conduit 35, the fluid collection device including a fluid impermeable barrier 43 defining a cavity therein, a porous material 44 disposed in the cavity, and the additional conduit disposed in the cavity, one of ordinary skill in the art would not be motivated to modify the diaper of Hu, Strickland, and Constantin to add such elements, as the diaper disclosed by Hu already includes an absorbent material 2004 (see Figs. 20A-20C) to absorb urine that is intended to be placed in the same position as the fluid collection device disclosed by Godinez, so there is no room to add the device of Godinez, and the diaper of Hu already performs the same function as the fluid collection device of Godinez in providing negative pressure.
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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/ARIANA ZIMBOUSKI/Primary Examiner, Art Unit 3781
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