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 Rejections - 35 USC § 112(b)
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 14-18 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 pre-AIA the applicant regards as the invention.
Claim 14 calls for “…and to press a portion of the fluid permeable outer layer extending across …” There is insufficient antecedent basis for this limitation in the claim. Parent claim 13 does not recite a fluid permeable outer layer. Instead, claim 13 describes “… at least one porous material disposed in the chamber and extending across the at least one opening…”
Claims 15-18 are rejected for depending on a rejected parent claim.
Claim Rejections - 35 USC § 102
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 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a) NOVELTY; PRIOR ART.—A person shall be entitled to a patent unless—
(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention; or
(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 6, 8, 12, 13 and 20-22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sanchez; Robert A. et al. (US 20190142624 A1).
Regarding claim 1, Sanchez discloses a fluid collection assembly (¶ [0005], [0062] A system … for collecting and transporting urine; ¶ [0067] FIG. 1 … system 100; ¶ [0132] FIG. 32 … assembly 1602; ¶ [0137] FIG. 34 … assembly 1802);
comprising: a fluid impermeable layer (¶ [0132], The impermeable casing 1604 can be the same or similar in structure and/or function to the impermeable casing 1504 described above with respect to FIGS. 27 and 28; ¶ [0137] FIG. 34 … impermeable backing 1850);
including a proximal end region, a distal end region spaced from the proximal end region, a front region defining at least one opening, and a back region opposite the front region (Figs. 32, 34, casing 1604 and backing 1850 comprise proximal, distal, front and back regions and an opening; ¶ [0126], The impermeable layer 1550 defines an elongated opening 1504A);
the fluid impermeable layer defining at least a chamber (¶ [0127], the impermeable casing 1504 can be configured to contain a permeable membrane disposed over a permeable support); and
a fluid outlet (¶ [0126], FIGS. 27 and 28 … outlet 1520; ¶ [0132] FIG. 32 … outlet 1620; ¶ [0137] FIG. 34 … outlet 1820);
at least one porous material disposed in the chamber and extending across the at least one opening (¶ [0132] FIG. 32 … Additionally, the assembly 1602 can include a permeable membrane 1630 … the permeable membrane 1630 can be a ribbed knit fabric sleeve; ¶ [0137] FIG. 34 … Additionally, the assembly 1802 can include a permeable membrane 1830);
one or more leak prevention features, the one or more leak prevention features including at least one of: at least a portion of the at least one porous material extending across the at least one opening exhibiting a generally wedge-like shape; or the fluid outlet positioned on the back region of the fluid impermeable layer, the fluid outlet positioned closer to the proximal end region of the fluid impermeable layer than to the distal end region (¶ [0126], FIGS. 27 and 28 … outlet 1520; ¶ [0132] FIG. 32 … outlet 1620; ¶ [0137] FIG. 34 … outlet 1820);
the fluid outlet spaced from the distal end region (annotated Fig. 32 shows that the fluid outlet is spaced from the distal end region).
Claim 1 specifies that the leak prevention features include a wedge-shaped porous material; or a proximally positioned fluid outlet, and phrases these two options in the alternative. Sanchez discloses two embodiments where the fluid outlet is positioned on the back region and is positioned closer to the proximal end region (Figs. 32 and Figs. 34-35). Each of these embodiments comprises an outlet located at, and defined by the proximal end. Sanchez’s assembly locates the outlet at the proximal end and therefore constitutes the second option, namely a proximally positioned fluid outlet. Each of the two cited embodiments in Figs. 32 and Figs. 34-35 individually teaches all features of claim 1.
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Regarding claim 13, Sanchez discloses all features of claim 1 as discussed above, including a fluid outlet spaced from the distal end region (annotated Fig. 32).
Sanchez further discloses a fluid storage container and a vacuum source (¶ [0074] The external receptacle 160, via the discharge line 122, can collect fluid exiting the reservoir 110 through the outlet 120. The external receptacle 160 can be a sealed container; ¶ [0075], In some implementations, the vacuum source 170 can assist and/or provide the pressure differential needed to draw fluid voided from the urethral opening of a user into the permeable support 140, into the reservoir 110, and from the reservoir 110 into the external receptacle 160);
wherein the chamber of the fluid collection assembly, the fluid storage container, and the vacuum source are in fluid communication with each other such 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 (¶ [0075], As a result of the decrease in pressure within the external receptacle 160 caused by the drawing of gaseous fluid out of the external receptacle 160, liquid and/or gaseous fluid can be drawn from the reservoir 110, through the outlet 120, through the discharge line 122, and into the external receptacle 160).
Regarding claims 6, 8 and 12, Sanchez discloses a fluid collection assembly wherein the one or more leak prevention features includes the fluid outlet positioned on the back region of the fluid impermeable layer (annotated Fig. 32 shows that the tube 1621 contacts portions of the back region, and that the outlet 1620 also includes portions of the back region);
further comprising at least one conduit extending through the fluid outlet and into the chamber (¶ [0132] FIG. 32 … The assembly 1602 can include a tube 1621 associated with the outlet 1620 such that fluid in the reservoir 1610 can be removed through the tube 1621 and out of the outlet 1620 via, for example, a vacuum source (not shown); ¶ [0137] FIG. 34 … The assembly 1802 can include a tube 1821 associated with the outlet 1820 such that fluid in the reservoir 1810 can be removed through the tube 1821 and out of the outlet 1820 via, for example, a vacuum source (not shown));
wherein the one or more leak prevention features further includes an extension extending from the distal end region of the fluid impermeable layer (¶ [0132] FIG. 32 … the impermeable casing 1604 can include a reservoir 1610; ¶ [0137] FIG. 34 … The impermeable casing 1804 can include a reservoir 1810).
Regarding claims 20-22, Sanchez further discloses a leg attachment device configured to be attached to a leg and a portion of at least one conduit that is disposed outside of the chamber; wherein the leg attachment device includes a strap (¶ [0089], In female applications, the assembly 102 can be placed between the legs or labia of the user and held snugly against the external urethra by the pressure of friction from the user's body, by the pressure of the legs or by such means as an undergarment, elastic strips, and/or adhesive tape);
wherein the fluid outlet is positioned on the back region of the fluid impermeable layer and the fluid collection assembly includes at least one conduit extending through the fluid outlet and into the chamber (¶ [0132], The assembly 1602 can include a tube 1621 associated with the outlet 1620 such that fluid in the reservoir 1610 can be removed through the tube 1621 and out of the outlet 1620 via, for example, a vacuum source (not shown); ¶ [0137], The assembly 1802 can include a tube 1821 associated with the outlet 1820 such that fluid in the reservoir 1810 can be removed through the tube 1821 and out of the outlet 1820 via, for example, a vacuum source (not shown)).
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Sanchez; Robert A. et al. (US 20190142624 A1) in view of Maling; Reginald George (GB 996370 A).
Regarding claim 2, Sanchez lacks a wedge-shaped porous portion. Maling discloses a fluid collection assembly (p. 1, lines 20-35, a female or male urinal; p. 1, lines 45-50, the female urinal includes a collector member 10);
comprising: a fluid impermeable layer defining at least a chamber and an opening (p. 2, lines 10-15, the outer covering 12 is impervious and is preferably made of soft rubber or thermoplastic synthetic resin);
a porous material disposed in the chamber and extending across the opening (p. 1, lines 85-95, the sponge material of which the collector member 10 is made is soft, and is preferably a cellulose derivative or a thermoplastic synthetic resin … has controllable properties in its absorbency and flow pattern to collect urine over its contact area and to direct the absorbed liquid into the drainage tube 11);
one or more leak prevention features including a portion of the porous material extending across the at least one opening exhibiting a generally wedge-like shape (p. 1, lines 65-10, at the end of the member 10 distant from said tongue is a projection 15).
Maling anchors the collection assembly by fitting it more closely to the wearer and also collects urine that diverges from the main drainage path (p. 2, lines 95-105, most of the urine which is excreted passes along the main flow path of each urinal and any that leeks away from or avoids such path is immediately absorbed and temporarily stored in the sponge). One would be motivated to modify Sanchez with Maling’s wedge-shaped porous portion to retain the assembly more securely and to capture any stray urine. Therefore, it would have been obvious to modify Sanchez with Maling’s wedge-shaped portion in order to capture any urine that strays from the central drainage path.
Claims 3-5 are rejected under 35 U.S.C. 103 as being unpatentable over Sanchez and Maling in view of Mizutani, Satoshi et al. (US 20040147895 A1).
Regarding claims 3-5, Sanchez and Maling lack a fluid permeable intermediate material. Mizutani discloses a fluid collection assembly (¶ [0003], [0014], [0019], [0101], FIG. 1, a basic interlabial pad 14 according to the present invention);
comprising: a porous material forming a wedge-shaped portion, wherein the at least one porous material includes a fluid permeable inner layer (Figs. 4(b), 4(c) each show an absorbent body 53 having a lower portion 53a);
a fluid permeable outer layer (¶ [0101], a water permeable surface side sheet 11, facing the body side; Figs. 4(b), 4(c) each show an analogous surface side sheet 51); and
at least one fluid permeable intermediate material disposed between a portion of the fluid permeable inner layer and the fluid permeable outer layer (¶ [0039] "In a mountain fold" of the present invention does not mean that a protruded area 54b is completely filled up with an absorbent body 53 as shown in FIG. 4(a), but means that a hollow space 57 is formed inside the side of the protruded area 54b facing the clothing (that is, the lower part of the convex) as shown in FIG. 4(b). This is not limited to folding an absorbent body 53b to form a ridge as shown in FIG. 4(c), but includes various shapes made by forming the absorbent body 53 to have a hollow space 57 formed inside the side of the protruded area 54b facing the clothing (that is, the lower part of the convex), such as an inverted U or V-shape, as shown in FIG. 4(b));
wherein the fluid permeable inner layer defines a drainage channel; wherein the at least one fluid permeable intermediate material exhibits a size and shape that corresponds to the drainage channel defined by the fluid permeable inner layer (¶ [0039] "In a mountain fold" … a hollow space 57 is formed inside the side of the protruded area 54b facing the clothing (that is, the lower part of the convex) as shown in FIG. 4(b). This is not limited to folding an absorbent body 53b to form a ridge as shown in FIG. 4(c), but includes various shapes made by forming the absorbent body 53 to have a hollow space 57 formed inside the side of the protruded area 54b facing the clothing (that is, the lower part of the convex), such as an inverted U or V-shape, as shown in FIG. 4(b)).
Mizutani demonstrates an alternative way to construct a wedge-shaped porous portion by stacking together pieces of absorbent material. One would be motivated to modify Sanchez and Maling with Mizutani’s fluid permeable intermediate material since Maling calls for providing regions with different porosities (p. 1, lines 85-95, controllable properties in its absorbency and flow pattern). Therefore, it would have been obvious to modify Sanchez and Maling with Mizutani’s intermediate material in order to construct a wedge-shaped porous portion with another known technique.
Claims 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Sanchez in view of Tazoe, Wataru et al. (US 20040236292 A1).
Regarding claims 9 and 10, Sanchez lacks an L-shaped fitting and a T-shaped fitting. Tazoe discloses an automatic urine disposal device (¶ [0001], [0008], [0021] In FIGS. 1 through 4, a urine receptacle 1; ¶ [0063] Another embodiment of the urine receptacle will be explained with reference to FIGS. 11 and 12);
comprising a fluid impermeable layer (¶ [0024] The outer sheet 4 is a liquid-impermeable, non-breathable thin sheet and is made of polyethylene film, for example); and
a conduit including: first and second perpendicular conduit and an L-shaped fitting or a T-shaped fitting that fluidly couples the first conduit to the second conduit (¶ [0063], FIGS. 11 and 12 … In the perforated urine drainage tube unit 115, one end of three perforated urine drainage tubes 125 are connected with a common tube 126).
Tazoe’s branching drainage tubes 125 and common tube 126 can be interpreted variously as an L-shaped fitting or T-shaped fitting, since they include multiple branches and tubes that connect at perpendicular angles (Fig. 11).
Tazoe distributes vacuum pressure through a porous material by arranging multiple conduits through the material. Tazoe also more securely anchors a conduit inside porous material, and prevents the conduit from being withdrawn under tension. A skilled artisan would have been able to modify Sanchez with Tazoe’s branched fittings by replacing Sanchez’s single-lumen conduit with Tazoe’s branched tube. One would be motivated to modify Sanchez with Tazoe’s L-shaped fitting and T-shaped fitting to more evenly distribute vacuum pressure through Sanchez’s porous material, and to more securely fasten the conduit. Therefore, it would have been obvious to modify Sanchez with Tazoe’s branched fittings in order to distribute negative pressure and anchor the conduit.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Sanchez in view of Radl; Christopher L. et al. (US 20210113749 A1).
Regarding claim 11, Sanchez lacks a shape memory material. Radl discloses a fluid collection assembly, wherein a portion of a conduit includes a shape memory material disposed therein or attached thereto (¶ [[0078] As best seen in FIGS. 18 and 21 the end-piece 128 includes a small diameter, e.g., 0.051 inch, central passageway 136 in which the malleable wire 130 is located. The malleable wire can be formed of any suitable material, e.g., stainless steel, aluminum, provided that it is biocompatible and can be readily bent into a desired shape and will hold that shape).
Radl retains a conduit’s shape to more closely hold a collection assembly near the patient’s urethra (¶ [0078], With the wire 130 located in the passageway 136 … the end-piece 128 can be bent into a somewhat arcuate shape, so that the cover 122B conforms closely and comfortably to the anatomy of the patient contiguous with the patient's urethra opening). One would be motivated to modify Sanchez with Radl’s shape memory material to retain the shape of Sanchez’s conduit during use. Therefore, it would have been obvious to modify Sanchez with Radl’s shape memory material in order to more securely hold the collection assembly’s position.
Claims 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Sanchez in view of Fixel; Irving E. (US 4372299 A).
Regarding claim 14, Sanchez lacks a wedge shaped pillow. Fixel discloses a generally wedge shaped pillow configured to fit between legs, the generally wedge shaped pillow (col. 1, lines 10-15, an immobilization device commonly known as an abduction pillow; col. 3, lines 25-35, pillow 10);
including an apex configured to be positioned proximate to a urethral opening (col. 3, lines 30-40, of special importance is the positioning of apex 11 well up within the crotch area of the patient); and
being capable of pressing a portion of a fluid permeable outer layer extending across an opening against the urethral opening (col. 3, lines 35-45, the abduction pillow can be firmly entrenched between a patient's legs and in close proximity to his pelvic area without interfering with medical apparatus inserted within the patient such as a catheter for draining his bladder; col. 4, lines 15-25, Channel 30 allows for routing and affixing a catheter from the patient to a drainage receptical. The catheter is shown in phantom in FIG. 3 and is not part of the invention).
Fixel supports a patient’s legs after hip surgery (col. 3, lines 25-35). One would be motivated to modify Sanchez with Fixel’s wedge shaped pillow in cases where a patient has undergone hip or other orthopedic surgery. Therefore, it would have been obvious to modify Sanchez with Fixel’s pillow in order to support a patient after orthopedic surgery.
Regarding claim 15, Sanchez discloses that the one or more leak prevention features includes the fluid outlet positioned on the back region of the fluid impermeable layer (¶ [0157], FIG. 45 is a cross-sectional illustration of an assembly 2500 … The outlet tube 2528 can be disposed on the casing 2504; ¶ [0165] The assembly 2702 can include an outlet tube 2726 that can be inserted into the casing 2704 through the opening 2780); and
the fluid collection assembly includes at least one conduit extending through the fluid outlet and into the chamber (¶ [0132] FIG. 32 … The assembly 1602 can include a tube 1621 associated with the outlet 1620 such that fluid in the reservoir 1610 can be removed through the tube 1621 and out of the outlet 1620 via, for example, a vacuum source (not shown); ¶ [0137] FIG. 34 … The assembly 1802 can include a tube 1821 associated with the outlet 1820 such that fluid in the reservoir 1810 can be removed through the tube 1821 and out of the outlet 1820 via, for example, a vacuum source (not shown)).
Sanchez lacks a pillow. Fixel discloses a wedge shaped pillow that defines a recess therethrough configured to have a conduit positioned therethrough (col. 4, lines 15-20, One or more channels 30 is provided in wedge portion 20 as shown in FIGS. 3 and 4. Channel 30 allows for routing and affixing a catheter from the patient to a drainage receptical).
Sanchez supports a patient’s legs along with a catheter. Regarding the rationale and motivation to modify Sanchez with Fixel’s pillow, see the discussion of claim 14 above.
Claims 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Sanchez and Fixel in view of Miner; Louise (US 20160183689 A1).
Regarding claims 16-18, Sanchez lacks a pillow. Fixel discloses a wedge shaped pillow including a compressible supporting member; and a casing positioned or positionable over the compressible supporting member (col. 4, lines 45-55, In FIG. 2, a foam outer covering 40 is shown partially in place around the periphery of pillow 10. Covering 40 may be made from soft foam having an approximate thickness of one-half inch).
Sanchez and Fixel do not explicitly disclose a fluid receiving layer and a fluid impermeable layer. Miner discloses a reusable sheet and pad system (¶ [0002], [0010], [0027], FIG. 1, the present invention contemplates a sheet pad 120; ¶ [0036], FIG. 2 … waterproof pad 200);
including a mattress comprising a compressible supporting member (¶ [0037], mattress 100); and
a casing positioned or positionable over the compressible supporting member, the casing including a fluid impermeable layer (¶ [0037], the waterproof pad 200 consists of three layers: a bottom waterproof layer 210, a middle absorbent layer 220, and a top fabric layer 230);
wherein the casing includes a fluid receiving layer disposed on an outer surface of the fluid impermeable layer (¶ [0037], the waterproof pad 200 consists of three layers: a bottom waterproof layer 210, a middle absorbent layer 220, and a top fabric layer 230).
Miner protects a mattress or other cushion against contamination with a reusable cover (¶ [0057], all elements contemplated by the present invention, including the fitted sheet, the sheet pad, the waterproof pad, the pillow cover and the various fastening means can be made from washable materials). One would be motivated to modify Sanchez and Fixel with Miner’s fluid receiving layer and fluid impermeable layer since Fixel calls for reusing the cover (col. 4, lines 45-55, In FIG. 2, a foam outer covering 40). Therefore, it would have been obvious to modify Sanchez and Fixel with Miner’s various layers in order to safely reuse a pillow by removing and washing its cover.
Response to Arguments
The objections to claims 2, 10, 13 and 17 for minor informalities and the rejections of claims 17 and 18 under 35 USC § 112(d) are withdrawn in view of the amendments and remarks filed 17 June 2026.
Applicant’s arguments filed 17 June 2026 regarding the rejection of claims 1-6, 8-18 and 20-22 as amended, under 35 USC § 102 and 103 over Sanchez, Maling, Mizutani, Tazoe, Radl, Fixel and Miner, have been fully considered but are not persuasive. Therefore, the rejections are maintained.
Applicant’s arguments regarding the double patenting rejections over Sanchez ‘376 have been considered and are persuasive. The double patenting rejections are withdrawn.
Applicant submits that the PTO has not established a prima facie case of anticipation against independent claim 1 (remarks p. 8). Applicant submits that Figure 35 is representative of the relied-upon Sanchez embodiments and an annotated Figure 35 is reproduced below (remarks p. 9). Examiner finds no annotated drawings in the remarks filed 17 June 2026.
Applicant reasons that the fluid outlet in Sanchez Figure 35 is not positioned on that back region. Instead, the outlet is positioned at an end of the assembly, which Sanchez describes as the end opposite the reservoir (remarks p. 9). Examiner responds that Fig. 32 is cited to show an outlet spaced from the distal end region. In Fig. 32, the assembly includes distal and proximal end regions, front and back regions, and a fluid outlet formed at the proximal end region. The front and back regions extend approximately symmetrically and merge at the proximal end region to form the fluid outlet.
Conclusion
THIS ACTION IS MADE FINAL. 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 extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to:
Tel 571-272-2590
Fax 571-273-2590
Email Adam.Marcetich@uspto.gov
The Examiner can be reached 8am-4pm Mon-Fri.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached at 571-270-5879. The fax phone number for the organization where this application is assigned is 571-273-8300.
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/Adam Marcetich/
Primary Examiner, Art Unit 3781
Prosecution Insights