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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 8/24/2026 has been entered.
Response to Arguments
Applicant's arguments filed 7/23/2026 have been fully considered but they are not persuasive. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies are not recited in the rejected claim(s). Applicant’s argument that the “sized and positioned” limitation is a structural requirement rather than an intended function of the wall/detector still faces the same problem. If the front wall and detector must structurally be sized and positioned to prevent viewing, it is unclear what it means for the front wall and detector to not be sized and positioned to prevent viewing. The front wall of Fletter (US 20200398024 A1) is 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. Fletter has a viewing window, but the claim does not require that one cannot view bodily fluids on the entire portion of the front wall—just “at least a portion of the front wall is opaque.” The sensor of Abir (US 20180149635 A1) is made of opaque materials and one cannot see through it—therefore, its position on the urine bag makes it positioned for preventing viewing. Structurally, the detector of Abir does block viewing because it is opaque so, as a result of it being sized and positioned in that location, it physically and structurally blocks visibility in that location. If there are further requirements for what it means for the front wall and detector to be sized and positioned to prevent viewing in the sense that there is a specific location that those components must be in relation to each other, or there must be no area of transparency at all, or specific size requirements, or any other narrowing limitations, those are not stated in the general term of being sized and positioned for preventing viewing.
The amendment to claim 1 is taught by Abir. The claim requires that the detector provides a visual indication of the presence or quantity of a bodily fluid. See paragraph [0067] of Abir—the urine analyzer has a screen configured to display the volume of urine in the urine collection bag.
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) and is configured to provide a visual indication of at least one of the presence or quantity of the one or more bodily fluids in the chamber responsive to detecting the bodily fluids (para. [0268, 0296]).
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 because one cannot see the contents of the bag (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 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) and is configured to provide a visual indication of at least one of the presence or quantity of the one or more bodily fluids in the chamber responsive to detecting the bodily fluids (para. [0268, 0296]).
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) 7 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 fails 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.
Claim(s) 10 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 Cheng et al. (US 20240042120 A1).
The combination of Abir and Fletter disclose the bag of claim 1, but fails to disclose a capacitor configured to detect at least one of a presence or quantity of one or more bodily fluids in the chamber.
Cheng teaches a similar device in the same field of endeavor with capacitor configured to detect at least one of a presence or quantity of one or more bodily fluids in the chamber (para. [0043]).
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 a capacitance sensor as shown in Cheng yielding predictable results namely, a common sensing method for detecting the presence of a fluid (para. [0043]).
Allowable Subject Matter
Claims 12-18 are allowed.
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 an examiner’s statement of reasons for allowance are stated in the final rejection filed 5/29/2026.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
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 11 September 2026
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