DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant's arguments filed 5/19/2026 have been fully considered but they are not persuasive. The amendment that redefines the front wall and the fluid detector to be sized and positioned to prevent viewing of bodily fluids in the chamber does not significantly change the scope of the claim, nor add significantly more patentable weight. The front wall of Fletter is arguably sized and positioned to prevent viewing of bodily fluids in the chamber because Fletter teaches an opaque wall for a more discrete appearance, and that opaque wall is sized according to be a standard size of a urine collection bag and is positioned such that one cannot see through it because of its material. The sensor of Abir is made of opaque materials and one cannot see through it—therefore, its position on the urine bag makes it positioned for preventing viewing. The transparent window of Fletter although is intended for a see-through volume measurement, the concept is the same of Abir’s sensor—a transparent area for data collection. The reliance on Fletter is for its opaque and transparent teachings, not the lined measurements because Abir’s sensor is capable of measuring capacity/volume of fluid; Abir just needs a transparent section to operate properly which is contemplated by Fletter just for a specific measurement. Further, while features of an apparatus may be recited either structurally or functionally, claims directed to a device must be distinguished from the prior art in terms of structure rather than function, because device claims cover what a device is, not what a device does (MPEP 2114). Thus, if a prior art structure is capable of performing the intended use as recited in the preamble, or elsewhere in a claim, then it meets the claim.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-2, 4-6, 8, 10-11, 19, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Abir (US 20180149635 A1) in view of Fletter et al. (US 20200398024 A1).
Regarding claim 1, Abir discloses a drainage bag (figs. 2A-2B), comprising:
one or more walls including a front wall and a back wall (figs. 2A-2B), the one or more walls defining at least:
an inlet (at top of bag, figs. 2A-2B); and
a chamber (space in bag, figs. 2A-2B); and
at least one fluid detector (sensor, para. [0225-0235]) configured to detect at least one of a presence or quantity of one or more bodily fluids in the chamber (fluid reservoir, para. [0225-0235]), the at least one fluid detector (sensor, para. [0225-0235]) is opaque (fig. 2B).
However, Abir fails to disclose wherein the front wall and the at least one fluid detector are sized and positioned to prevent viewing of bodily fluids in the chamber.
Fletter teaches a similar device in the same field of endeavor wherein the front wall (18f, fig. 25) (para. [0065]) and thereby at least the portion of the front wall that is opaque (para. [0065]), and wherein the front wall and the at least one fluid detector are sized and positioned to prevent viewing of bodily fluids in the chamber (para. [0065]).
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 bag of Abir and incorporate the opaqueness of Fletter to have a more discrete user experience during use and disposal (para. [0065]).
Regarding claim 2, the combination of Abir and Fletter discloses the bag of claim 1 and Abir further discloses wherein the at least one fluid detector (sensor, para. [0225-0235]) is at least partially disposed on at least at least one exterior surface of the one or more walls (figs. 1, 2A-2B).
Regarding claim 4, the combination of Abir and Fletter discloses the bag of claim 1 and Abir further discloses wherein the at least one fluid detector (sensor, para. [0225-0235]) is disposed on at least at least one interior surface of the one or more walls (figs. 1, 2A-2B, para. [0425]).
Regarding claim 5, the combination of Abir and Fletter discloses the bag of claim 1 and Abir further discloses wherein the at least one fluid detector (sensor, para. [0225-0235]) is disposed on a transparent portion of the one or more walls (figs. 2A-2B, para. [0425]).
Regarding claim 6, the combination of Abir and Fletter discloses the bag of claim 1 and Abir further discloses wherein the at least one fluid detector forms part of the one or more walls (figs. 2A-2B, para. [0425]).
Regarding claim 8, the combination of Abir and Fletter discloses the bag of claim 1 and Abir further discloses wherein the at least one fluid detector includes at least one pH indicator (para. [0225-0235]).
Regarding claim 10, the combination of Abir and Fletter discloses the bag of claim 1 and Abir further discloses wherein the at least one fluid detector includes a capacitor (para. [0300]).
Regarding claim 11, the combination of Abir and Fletter discloses the bag of claim 1 and Abir further discloses wherein the at least one fluid detector indicates a quantity of the one or more bodily fluids in the chamber (para. [0205-0210]).
Regarding claim 19, the combination of Abir and Fletter discloses the drainage bag of claim 1. Abir further discloses a fluid collection system (para. [0225-0234]), comprising: a fluid collection assembly (not shown, but the drainage tube connected to the drainage bag is attached to some assembly in order to collect fluid, most likely a catheter or pad assembly, para. [0225-0234]); the drainage bag of claim 1; and at least one drainage tube (figs. 2A-2B) extending from the inlet of the drainage bag to the fluid collection assembly (not shown, but the drainage tube connected to the drainage bag is attached to some assembly in order to collect fluid, most likely a catheter or pad assembly, para. [0225-0234]).
Regarding claim 20, Abir discloses a method of using a drainage bag (urine collection bag, para. [0226]), the method comprising: receiving a quantity of one or more bodily fluids into a chamber (fluid reservoir, para. [0228], although not explicit; the urine collection bag, in use, would receive urine) of the drainage bag, the drainage bag including one or more walls that defines the chamber (figs. 2A and 2B show the two walls/sides of the bag), the one or more wall including a front wall and a back wall (figs. 2A and 2B show the two walls of the bag), and responsive to receiving the quantity of the bodily fluids into the chamber, indicating at least one of a presence or quantity of the one or more bodily fluids in the chamber with at least one fluid detector (sensor, para. [0287, 0225]), wherein the at least one fluid detector is opaque (figs. 2A-2B).
Abir fails to disclose wherein at least a portion of the one or more front wall is opaque; and wherein the front wall and the at least one fluid detector are sized and positioned to prevent viewing of bodily fluids in the chamber.
Fletter teaches a similar device in the same field of endeavor wherein at least a portion of the front wall (18f, fig. 25) is opaque (para. [0065]) and wherein the front wall and the at least one fluid detector are sized and positioned to prevent viewing of bodily fluids in the chamber (para. [0065]).
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 bag of Abir and incorporate the opaqueness of Fletter to have a more discrete user experience during use and disposal (para. [0065]).
Regarding claim 21, the combination of Abir and Fletter discloses the bag of claim 1, and Abir discloses the fluid detector (sensor, para. [0225-0235]). However, Abir fails to disclose wherein the front wall defines a hole and the at least one fluid detector fills the hole.
Fletter teaches wherein the front wall (18f) defines a hole (area void of opaque material 42, fig. 25).
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 bag of Abir and incorporate the hole of Fletter wherein the fluid detector fills the hole because the sensor needs a transparent material to operate properly with its photodetection capabilities (para. [0287]).
Regarding claim 22, the combination of Abir and Fletter discloses the bag of claim 1, and Abir discloses the fluid detector (sensor, para. [0225-0235]). However, Abir fails to disclose wherein the front wall includes a transparent section and the at least one fluid detector covers at least substantially all of the transparent section.
Fletter teaches a front wall (18f) with a transparent section (42, fig. 25).
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 bag of Abir and incorporate the transparent section of Fletter wherein the fluid detector covers at least substantially all of the transparent section because the sensor needs a transparent material to operate properly with its photodetection capabilities (para. [0287]).
Regarding claim 23, the combination of Abir and Fletter discloses the bag of claim 22. Abir fails to disclose wherein the transparent section exhibits an elongated shape.
Fletter teaches wherein the transparent section (42, fig. 25) exhibits an elongated shape (fig. 25).
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 bag of Abir and incorporate the transparent section of Fletter because the sensor needs a transparent material to operate properly with its photodetection capabilities (para. [0287]).
Claim(s) 12-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burgess et al. (US 20080140033 A1) in view of Abir (US 20180149635 A1), and in further view of Fletter (US 20200398024 A1).
Regarding claim 12, Burgess discloses a fluid collection system (fig. 4), comprising: a wheelchair (72) including a plurality of wheels, a seat, and a back rest (fig. 4), the wheelchair forming a front side (side of the back rest where the user sits, fig. 4) and a back side (the side of the back rest not touching the user, fig. 4) opposite the front side (fig. 4); and a drainage bag (10) of any one including: one or more walls including a front wall and a back wall (the rectangular flat bag has two faces/walls, para. [0015]), the one or more walls defining at least: an inlet (27); and a chamber (space in bag 12, para. [0018]).
However, Burgess fails to disclose at least one fluid detector configured to detect at least one of a presence or quantity of one or more bodily fluids in the chamber, the at least one fluid detector is opaque.
Abir teaches at least one fluid detector (sensor, para. [0225-0235]) configured to detect at least one of a presence or quantity of one or more bodily fluids in the chamber (para. [0225-0235]), the at least one fluid detector (sensor, para. [0225-0235]) is opaque (fig. 2B).
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 system of Burgess and incorporate the detector of Abir to analyze properties of the urine and provide insights to the caregiver or user (para. [0225-0235]).
However, the combination fails to disclose wherein at least the portion of the front wall is opaque, and wherein the front wall and the at least one fluid detector are sized and positioned to prevent viewing of bodily fluids in the chamber.
Fletter teaches a similar device in the same field of endeavor wherein at least a portion of the front wall (18f, fig. 25) is opaque (para. [0065]) and wherein the front wall and the at least one fluid detector are sized and positioned to prevent viewing of bodily fluids in the chamber (para. [0065]).
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 system of Burgess and Abir and incorporate the opaqueness of Fletter to have a more discrete user experience during use and disposal (para. [0065]).
Regarding claim 13, the combination of Burgess, Abir, and Fletter discloses the system of claim 12. Burgess further discloses wherein the drainage bag (10) is adjacent to the back side (fig. 4).
Regarding claim 14, the combination of Burgess, Abir, and Fletter discloses the system of claim 13. Burgess further discloses wherein the drainage bag includes a top side (12) and a bottom side (14) opposite the top side (fig. 1), a back side (back-facing unseen face in figs. 1 and 4) generally facing the same direction as the front side of the wheelchair (fig. 4), and a front side (front-facing face in fig. 1) opposite the back side and generally facing the same direction as the back side of the wheelchair (fig. 4).
However, Burgess fails to disclose wherein at least one fluid detector is disposed on or forms part of at least one of the top side or the front side of the drainage bag.
Abi teaches wherein at least one fluid detector (sensor, para. [025-0235]) is disposed on or forms part of at least one of the top side or the front side of the drainage bag (figs. 2A-2B).
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 system of Burgess and incorporate the detector of Abir to analyze properties of the urine and provide insights to the caregiver or user (para. [0225-0235]).
Regarding claim 15, the combination of Burgess, Abir, and Fletter discloses the system of claim 12. Burgess further discloses wherein the wheelchair includes a shelf (50) and the drainage bag (10) is configured to be disposed on the shelf (50, the reinforcements on the bag are attached and mounted to a bracket and hung from it, para. [0030]).
Regarding claim 16, the combination of Burgess, Abir, and Fletter discloses the system of claim 12. Burgess further discloses wherein the drainage bag (10) includes a top side (12) and a bottom side (14) opposite the top side (fig. 1), the front wall (front-facing face fig. 1) generally facing the same direction as the back side of the wheelchair (fig. 4), and the back wall (back-facing unseen wall fig. 1) generally facing the same direction as the front side of the wheelchair (fig. 4).
However, Burgess fails to disclose wherein the at least one fluid detector is disposed on or forms part of at least one of the front side, the back side, a portion of the top side proximate to the front side, or a portion of the top side proximate to the back side.
Abir teaches wherein the at least one fluid detector (sensor, para. [025-0235]) is disposed on or forms part of at least one of the front side (figs. 2A-2B), the back side, a portion of the top side proximate to the front side, or a portion of the top side proximate to the back side.
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 system of Burgess and incorporate the detector of Abir to analyze properties of the urine and provide insights to the caregiver or user (para. [0225-0235]).
Claim(s) 17 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burgess (US 20080140033 A1) in view of Abir (US 20180149635 A1), Fletter (US 20200398024 A1), and in further view of Kuntz (US 4747166 A).
Regarding claims 17 and 18, the combination of Burgess, Abir, and Fletter disclose the system of claim 12. However, the combination fails to disclose a fluid collection assembly—i.e., the catheter or pad assembly that first collects the urine from the user, rather focuses on the waste storage components of the system. Namely, the combination fails to disclose a fluid collection assembly; and at least one drainage tube extending from the inlet of the drainage bag to the fluid collection assembly (claim 17); and wherein the fluid collection assembly includes: at least one fluid impermeable barrier at least defining a chamber, at least one opening, and a fluid outlet; and at least one porous material disposed in the chamber (claim 18).
Kuntz teaches a similar system in the same field of endeavor with a fluid collection assembly (12, fig. 1); and at least one drainage tube (18) extending from the inlet of the drainage bag (14) to the fluid collection assembly (12) (claim 17); and wherein the fluid collection assembly (12, fig. 1) includes: at least one fluid impermeable barrier (backing layer 36a, column 4 lines 11-14, column 2 lines 29-30) at least defining a chamber (fig. 2), at least one opening (28), and a fluid outlet (24); and at least one porous material (62, column 5 lines 57-58) disposed in the chamber (fig. 6) (claim 18).
Kuntz teaches a system used by wheelchair users and It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the fluid collection assembly of Kuntz to complete the system wherein the urine is acquired from the user via a pad assembly with a reasonable expectation of success because Burgess and Abir teach a urine collection bag with a tube that is contemplated to be required to be connected to the user in some way—whether it is a catheter connection or a pad assembly.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Abir (US 20180149635 A1) in view of Fletter (US 20200398024 A1), and in further view of Edwards et al. (US 20160327553 A1).
The combination of Abir and Fletter disclose the bag of claim 1, but fail to disclose wherein the at least one fluid detector includes at least one hydrochromatic ink. Edwards teaches the use of detecting analytes in urine with hydrochromatic ink (para. [0026]).
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 sensor of Abir and incorporate the hydrochromic-based detection of Edwards to yield the same, predictable result; namely, a sensor that detects fluid in the urine and changes color. Further, Abir discloses color changing technology used in urine collection bags (para. [0306]) but does not specify the use of color-changing inks.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Abir (US 20180149635 A1) in view of Fletter (US 20200398024 A1), and in further view of Lowe et al. (US 20060166350 A1).
The combination of Abir and Fletter disclose the bag of claim 1, but fail to disclose wherein the at least one fluid detector includes at least one hologram. Lowe teaches the use of detecting analytes in urine with holograms (abstract and para. [0026]).
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 sensor of Abir and incorporate the hologram-based detection of Lowe to yield the same, predictable result; namely, a sensor that detects analytes in the urine.
Allowable Subject Matter
Claim 3 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including 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: Abir, Fletter, and Burgess all teach urine collection bags, but they are all single-chambered. No prior art disclosing multi-chambered or dual-chambered bag within the art of urine collection storage bags could be found. Abir teaches a singular bag to contain the collected urine. Without relevant prior art nor a clear rationale to rely on, it would not have been obvious to modify the bag of Abir to have two compartments in which they are fluidly connected via holes on the middle wall. A duplication of parts would still not suffice because the motivation is unclear why adding a third wall to separate the chamber into two components would have been obvious.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIN A KIM whose telephone number is (703)756-4738. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm (EST).
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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 or proceeding is assigned is 571-273-8300.
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/ERIN A KIM/Examiner, Art Unit 3781
/SUSAN S SU/Primary Examiner, Art Unit 3781 26 May 2026
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