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 .
Status of Claims
Claims 1-19 are pending, of which Claims 1, 6-12 are amended and Claims 14-19 are new. All claims are examined on the merits. No new matter is found.
Response to Arguments
Applicant’s arguments with respect to the claim have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Objections
Claim 8 is objected to because of the following informalities:
Re Claim 8, a claim term, regarding the possible seems to have switched from singular to plural in the recitations “the further chemical reagent being configured to undergo a change in color or shade, from a further possible color or shade changes of the chemical reagent” and “wherein each of the further plurality of different possible color or shade corresponds …” Examiner thinks that Applicant intends to recite “the further chemical reagent being configured to undergo a change in color or shade selected from a further plurality of possible color or shade changes of the chemical reagent” and “wherein each of the further plurality of different possible color or shade changes corresponds …”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 8 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Re Claim 8, it is not clear what is meant by “the further chemical reagent being configured to undergo a change in color or shade, from a further possible color or shade changes of the chemical reagent”. One interpretation is that the further chemical reagent can undergo a color or shade change; the second interpretation is that the further chemical reagent undergoes a first color/shade change and then from that first color/shade change, undergoes a second color/shade change. Examiner thinks that the first interpretation is the most reasonable.
Claim Rejections - 35 USC § 102
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)(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.
Claims 1-4, 6, 13, 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Song et al. (US 2013/0066289, note that this is different from the Song reference used in the Non-Final Rejection).
Re Claim 1, Song discloses a wearable absorbent article (training pant 20, Fig. 4) configured to receive discharged urine of a wearer, the article comprising:
a liquid-permeable top sheet (topsheet 42, [0086]);
an intermediate liquid-absorbent layer (absorbent core 44); and
a bottom sheet including:
a liquid-impermeable backing layer (backsheet 40, [0083]), said liquid-impermeable backing layer having an upper surface, said upper surface facing said intermediate liquid-absorbent layer; and
at least one indicator (sensor 100, [0039] “color-changing composition … includes … at least one pH indicator”), each of the at least one externally visible an indicator being made from an adhesive binder coated or impregnated with at least one a chemical reagent ([0045] discloses a printed layer adhered to the substrate and the printed layer includes a color-changing composition and standard colorant), the indicator facing the liquid-absorbent layer being disposed on said upper surface of said liquid-impermeable backing layer ([0040] “the color-changing composition is in contact with the absorbent core” and [0081] “the sensor 100 is located between the backsheet 40 and the absorbent core 44 so that it may be viewed through the backsheet”), each of the at least one the chemical reagent being configured to undergo a change in color or shade, from a plurality of different possible color or shade changes of the chemical reagent, upon contact with the discharged urine; and
wherein each of the plurality of different possible color or shade corresponds with a level of an analyzed component or with presence or absence of the analyzed component (implied by “pH indicator,” e.g., [0039]) and the change in color or shade of the chemical reagent is externally visible on the indicator through the bottom sheet and the liquid-impermeable backing layer; and
wherein the adhesive binder includes a water-insoluble matrix (at least [0039] “The matrix-forming component can be a water-insoluble, film-forming polymer or a mixture of a number of polymers or an ink base/binder…”), the water-insoluble matrix immobilizing the chemical reagent to inhibit the chemical reagent from leaching into the intermediate liquid-absorbent layer when wetted (e.g., [0041]-[0042] disclosing the composition being printed as a water-insoluble film layer on the liquid-impermeable backing layer, thus immobilizing the chemical reagent/pH indicator onto the backing layer).
Re Claim 2, Song discloses claim 1 and further disclosing wherein the liquid-permeable top sheet is a non-woven sheet ([0086]).
Re Claim 3, Song discloses claim 1 and further disclosing wherein the bottom sheet is a non- woven sheet ([0084]).
Re Claim 4, Song discloses claim 2 and further disclosing wherein the liquid-permeable top sheet and the bottom sheet are constructed of non-woven, natural fibers ([0044] & [0086]).
Re Claim 6, Song discloses claim 1 and further disclosing wherein the liquid-impermeable backing layer and the indicator are integrally formed (since the wetness indicator is printed as a film onto the backing layer, Examiner interprets that the indicator and the backing layer are integral).
Re Claim 13, Song discloses claim 1 and further disclosing wherein the article is a diaper (Fig. 4).
Re Claim 16, Song discloses claim 1 and further disclosing wherein the adhesive binder of the indicator includes a hot-melt adhesive selected from ethylene-vinyl acetate copolymers, styrenic block copolymers, or polyamides ([0034]).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Song in view of Radovcic (US 2021/0022930).
Re Claim 5, Song discloses claim 1 but does not expressly disclose wherein the article is biodegradable. Radovcic discloses a compostable absorbent article that also has pH indicator (e.g., [0013]). It would have been obvious to one skilled in the art at the time of filing to modify with Radovcic's teaching of using compostable/biodegradable materials so as to reduce the environmental impact of the absorbent article.
Claims 7-9, 17 are rejected under 35 U.S.C. 103 as being unpatentable over Song in view of Song (US 2014/0324004, hereinafter “Song ‘004”).
Re Claim 7, Song discloses claim 1 but does not disclose an acquisition layer in between the liquid-permeable top sheet and the liquid-absorbent layer, the acquisition layer being configured to accelerate diffusion of liquid from the top sheet into the absorbent layer. Song ‘004 discloses and absorbent article having an acquisition layer ([0101] "surge management layer") in between the liquid-permeable top sheet and the liquid-absorbent layer, the acquisition layer being configured to accelerate diffusion of liquid from the top sheet into the absorbent layer ([0101] "surge management layer helps to decelerate and diffuse surges or gushes of liquid"). It would have been obvious to one skilled in the art at the time of filing to add the acquisition layer since this helps to move the liquid quickly away from the topsheet and thus reducing the amount of wetness in contact with the user’s skin.
Re Claim 8, Song discloses claim 1 but does not teach a further indicator being coated or impregnated with a further chemical reagent. Song ‘004 discloses an absorbent article having multiple wetness indicators comprising different chemical reagents (Fig. 4, [0067]) to provide multisensory feedback to the user (e.g., [0032]), the chemical reagents may provide different color/shade changes upon contact with discharged urine.(e.g., [0067], [0079]), wherein each of the further plurality of different possible color or shade changes corresponds with a level of a further analyzed component or with presence or absence of the analyzed component (e.g., pH indicator would show different colors based on acidity level of the liquid). It would have been obvious to one skilled in the art at the time of filing to modify with the plurality of indicators as taught in Song ‘004 to give a user/caretaker a more complete picture of the wetness condition of the diaper and the associated potential medical issues the user may have.
Since Song also discloses that the change in color or shade of the further chemical reagent is externally visible on the further indicator through the bottom sheet and the liquid-impermeable backing layer, it would be reasonably expected that the further/additional indicator is also visible through the bottom sheet and backing layer.
Re Claim 9, Song discloses claim 1 but does not disclose wherein the at least one indicator is coated or impregnated with a further chemical reagent, the further chemical reagent being spaced from the chemical reagent. Song ‘004 discloses an absorbent article having at least one indicator, wherein the at least one indicator coated or impregnated with a plurality of the spaced apart chemical reagents ([0067]). It would have been obvious to one skilled in the art at the time of filing to modify with Song ‘004 so as to be able to detect more than just pH in the urine.
Re Claim 17, Song discloses claim 1 but does not disclose wherein the indicator has been applied to the liquid-impermeable backing layer as a continuous or intermittent stripe aligned longitudinally. Song ‘004 discloses multiple patches of sensor (200, 202, Fig. 4) that form intermittent stripes in the longitudinal direction of the article. It would have been obvious to one skilled in the art at the time of filing to modify with the configuration shown in Song ‘044 such that the color/shade change can be viewed even in the front and/or rear of the article.
Claims 10-12, 15, 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Song in view of Gael et al. (US 6,203,496).
Re Claim 10, Song discloses claim 1, but does not disclose wherein each of the at least one indicator is labelled with an identifier of the chemical reagent, characteristic or medical condition to be detected thereby. Gael discloses a diaper having a color-changing chemical reagents inside the diaper so as to detect abnormal levels of substances in the urine, such as leukocyte, blood, glucose, nitrites, proteins, etc., so as to allow a caretaker easy monitoring of a patient's medical conditions (see e.g., Abstract). Gael further discloses a separate color chart that identifies the reagent and the condition that would be detected, such as a high level of glucose (see col. 3 lines 64-67 and Table 1). It would have to one skilled in the art at the time of filing to modify Song by gleaning from Gael so a less trained caretaker can also quickly gauge if the patient has a medical condition that needs immediate attention.
Re Claims 11-12, Song discloses claim 1, but does not teach a color chart providing an indicator scale associating each color or shade with a corresponding level of the analyzed component or with presence or absence of the analyzed component, or wherein the color chart is a standalone component. Gael discloses a diaper having a color-changing chemical reagent inside the diaper so as to detect abnormal levels of substances in the urine, such as leukocyte, blood, glucose, nitrites, proteins, etc., so as to allow a caretaker easy monitoring of a patient's medical conditions (see e.g., Abstract). Gael further discloses a separate color chart that allows a caretaker to rapidly gauge if the color change indicates a medical condition that needs attention (col. 3 lines 64-67). It would have been obvious to one skilled in the art at the time of filing to modify Song by gleaning from Gael so a less-trained caretaker can also quickly gauge if the patient has a critical medical condition.
Re Claim 15, Song discloses claim 1 but does not disclose wherein the chemical reagent is configured to react to an analyte in the discharged urine, the analyte being at least one of glucose, a protein, leukocytes, nitrites, ketones, and bilirubin. Gael discloses a diaper having a color-changing chemical reagents inside the diaper so as to detect abnormal levels of substances in the urine, such as leukocyte, blood, glucose, nitrites, proteins, etc., so as to allow a caretaker easy monitoring of a patient's medical conditions (see e.g., Abstract). It would have to one skilled in the art at the time of filing to modify Song by gleaning from Gael so the diaper can be useful in a wider range of applications (i.e., not limited to detecting moisture content or pH of the urine).
Re Claims 18-19, Song and Gael combine to disclose claim 11 but neither discloses wherein the color chart is printed on packaging or a packaging insert or that the color chart is printed directly on the absorbent article. However, it should be noted that since the color chart is used for allowing a caretaker to easily monitor a user/patient’s conditions, it would be desirable to have the color chart be included with the absorbent article so it is easily obtainable and accessible. As such, one skilled in the art would find it obvious at the time of filing to modify Song and Gael such that the color chart is nearby, e.g., included on the package that holds the absorbent article or directly on the absorbent article, such that the caretaker would not need to expend time and energy to look for the color chart that explains what each color of the indicator may mean.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Song.
Re Claim 14, Song discloses claim 1 but does not explicitly disclose wherein the chemical reagent is configured to undergo the color or shade change within thirty to one-hundred twenty seconds after the discharged urine contacts the chemical reagent. However, it is well known that many pH indicators (e.g., litmus paper) change color within seconds. Additionally, Song already expressed the desire to prevent exposing skin to a prolonged period of wetness because it can lead to skin irritation ([0002]), thus the indicator that alerts a user/caretaker to wetness in the diaper should change in color in a very short time so the user/caretaker can be alerted in a timely fashion. Therefore one skilled in the art would be motivated at the time of filing to set up the indicator such that the chemical reagent can undergo color/shade change within a very short time frame, such as less 30-120 seconds.
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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/SUSAN S SU/ Primary Examiner, Art Unit 3781
2 February 2026