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 Amendment
In response to the amendment filed March 29, 2026, claims 1, 8, and 11 are amended. Claim 29 has been cancelled and claims 2, 4, 7, 9-10, 12-14, 16-17, 19-20, 22, 24, 26, 28, 31-32, 35-36, 39-40, and 45 were previously cancelled. No new claims are added. Claims 1, 3, 5-6, 8, 11, 15, 18, 21, 23, 25, 27, 30, 33-34, 37-38, 41-44, and 46-47 are pending.
Response to Arguments
Applicant’s arguments, see Remarks, filed March 29, 2026, with respect to the objection to claim 1 has been fully considered and are persuasive in view of the amendments. The objection of claim 1 has been withdrawn.
Applicant’s arguments, see Remarks, filed March 29, 2026, with respect to the rejection of claims 8 and 11 under 35 U.S.C 112b have been fully considered and are persuasive in view of the amendments. The rejection of claims 8 and 11 under 35 U.S.C 112b have been withdrawn.
Applicant’s arguments, see Remarks, filed March 29, 2026, with respect to the rejection of claims 1, 3, 8, 11, 15, 18, 21, 23, 25, 27, 29-30, 33-34, 37-38, and 41-44 under 35 U.S.C 103 as being unpatentable over Smith (US 6126597 A1; previously cited by applicant) in view of Hershcovitz-Fundoiano (US 20190240373 A1; previously cited) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Song (US 20090155122 A1; previously cited).
As to the Applicant’s argument that Hershcovitz-Fundoiano teaches away from “wherein the C1-16 aliphatic carboxylic acid is selected from citric acid, oxalic acid, tartaric acid, succinic acid, glutaric acid, lactic acid, pyruvic acid, hydroxypropionic acid, hydroxyvaleric acid, adipic acid and suberic acid or a combination thereof”. The Examiner respectfully disagrees since Hershcovitz-Fundoiano does not directly disparage such a feature. Indeed, the use of the expression “In some embodiments…” in both sentences in paragraph 0090 connotes that such a feature is compatible with the teachings of Hershcovitz-Fundoiano, but is not preferred. However, teaching a preference is not a teaching against other possible conditions.
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.
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.
Claims 1, 3, 6, 8, 11, 15, 18, 21, 23, 25, 27, 30, 33-34, 37-38, 41-44, and 46-47 are rejected under 35 U.S.C. 103 as being unpatentable over Smith (US 6126597 A1; previously cited by applicant) in view of Hershcovitz-Fundoiano (US 20190240373 A1; previously cited) and Song (US 20090155122 A1; previously cited).
With respect to claim 1, Smith discloses
an article for detecting amniotic fluid (see col 1 lines 5-12, article in the form of a multilayered pad which can detect the presence of amniotic fluid, and see Fig. 1 and col 4 lines 23-43, article #10), comprising:
a membrane layer (see col 4 lines 43-49, upper outer layer #26) ;
a transfer layer having a first side and a second side (see col 5 lines 18-20 and col 5 lines 66-67-col 6 lines 1-5, pH sensitive component #34 which defines a strip which is fitted adjacent the upper outer layer #26 and in between the upper outer layer #26 and lower outer layer #28);
an absorbent layer having a first side and a second side (see col 5 lines 15-20, additional absorbent layer in between the upper outer layer #26 and the lower outer layer #28); and
a base layer (see col 4 lines 43-49, lower outer layer #28), wherein:
the membrane layer is adjacent to the first side of the transfer layer (see col 5 lines 18-20 and col 5 lines 66-67-Col 6 lines 1-5, pH sensitive component #34 which defines a strip which is fitted adjacent the upper outer layer #26 and in between the upper outer layer #26 and lower outer layer #28);
the second side of the transfer layer is adjacent to the first side of the absorbent layer (see col 5 lines 15-20, additional absorbent layer in between the upper outer layer #26 and the lower outer layer #28; and see col 5 lines 18-20 and col 5 lines 66-67-Col 6 lines 1-5, pH sensitive component #34 which defines a strip which is fitted adjacent the upper outer layer #26 and in between the upper outer layer #26 and lower outer layer #28); and
the second side of the absorbent layer is adjacent to the base layer (see col 5 lines 15-20, additional absorbent layer in between the upper outer layer #26 and the lower outer layer #28), and further wherein:
the transfer layer comprises an indicator composition (see col 5 lines 66-67-Col 6 lines 1-10, pH sensitive component #34 which defines a strip which is an indicator) disposed thereon comprising:
[…]; and
an indicator agent (see col 5 lines 66-67-Col 6 lines 1-10, pH sensitive component #34 which defines a strip such as a strip of NITRAZINE as an indicator agent),
wherein the membrane layer comprises a woven polyolefin layer or a nonwoven polyolefin layer (see col 4 lines 46-47 and lines 57-60: non-woven polypropylene; and see col 4 lines 50-57, the upper outer layer #26 can be made from any of the material conventional for the use of being compliant, soft feeling that is non-irritating to the parts of user’s skin with which it is in contact); , and
wherein the membrane layer further comprises a hydrophilic coating disposed thereon (see col 4 lines 50-57, the upper outer layer #26 can be made from any of the material conventional for the use of being compliant, soft feeling that is non-irritating to the parts of user’s skin with which it is in contact; and see col 5 lines 20-29, hydrophilic fiber coating to absorb and contain liquid).
Although Smith discloses an indicator agent (see col 5 lines 66-67-Col 6 lines 1-10, pH sensitive component #34 which defines a strip such as a strip of NITRAZINE as an indicator agent), Smith does not disclose that the transfer layer comprises an indicator composition disposed thereon comprising: one or more indicator composition polymers; a non-cyclic plasticizer; a hydrophilic surfactant; a C1-16 aliphatic carboxylic acid, wherein the C1-16 aliphatic carboxylic acid is selected from citric acid, oxalic acid, tartaric acid, succinic acid, glutaric acid, lactic acid, pyruvic acid, hydroxypropionic acid, hydroxyvaleric acid, adipic acid and suberic acid or a combination thereof; an ion-balance reagent; and an indicator agent.
Hershcovitz-Fundoiano teaches an indicator composition (see paragraph 0021, indicator composition) comprising: one or more indicator composition polymers (see paragraph 0021, a plurality of polymers); a non-cyclic plasticizer (see paragraph 0021, a non-cyclic plasticizer); a hydrophilic surfactant (see paragraph 0021, hydrophilic surfactant); a C1-16 aliphatic carboxylic acid (see paragraph 0021, carboxylic acid; and see paragraph 0082, in the form of Ar-COOH where Ar is unsubstituted or substituted); an ion-balance reagent (see paragraph 0021, ion-balance reagent); and an indicator agent (see paragraph 0021, indicator agent).
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 Smith with the teachings of Hershcovitz-Fundoiano to have added an indicator composition with multiple components because it would have resulted in the predictable result of detecting amniotic fluid in a one-step method by combining the diagnostic formulations taught by Hershcovitz-Fundoiano to account for various markers (Hershcovitz-Fundoiano: see [0009]) and enable initial self-detection for a patient (Hershcovitz-Fundoiano: see [0010]).
Although Smith discloses an indicator agent (see col 5 lines 66-67-Col 6 lines 1-10, pH sensitive component #34 which defines a strip such as a strip of NITRAZINE as an indicator agent), Smith and Hershcovitz-Fundoiano do not specifically teach wherein the C1-16 aliphatic carboxylic acid is selected from citric acid, oxalic acid, tartaric acid, succinic acid, glutaric acid, lactic acid, pyruvic acid, hydroxypropionic acid, hydroxyvaleric acid, adipic acid and suberic acid or a combination thereof.
Song teaches carboxylic acids being utilized as a reagent (see paragraph 0025: carboxylic acids) where the reagents are present on a layer to detect presence of an analyte (see paragraph 0028-0029). Song further teaches wherein suitable carboxylic acids can be citric acid, glycolic acid, lactic acid, acetic acid, maleic acid, gallic acid, malic acid, succinic acid, glutaric acid, benzoic acid, malonic acid, salicylic acid, gluconic acid, and mixtures thereof (see paragraph 0025).
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 Smith and Hershcovitz-Fundoiano with the teachings of Song to have chosen specific types of carboxylic acid because it would have resulted in the predictable result of altering a pH so as to alter the speed of a reaction to inhibit an enzyme-catalyzed substrate reaction such as a nitrite reaction to properly detect the presence or absence of an analyte (Song: see [0018]-[0025]).
With respect to claim 3, all limitations of claim 1 apply in which Smith further discloses wherein the nonwoven polyolefin layer comprises polypropylene (see col 4 lines 57-60, non-woven polypropylene)
With respect to claim 6, all limitations of claim 1 apply in which Smith further discloses wherein the transfer layer comprises a strip of flexible material (see col 5 lines 66-67) however Smith and Hershcovitz-Fundoiano do not specifically disclose wherein the transfer layer comprises a woven polyolefin layer or a nonwoven polyolefin layer.
Song teaches a multilayered device for detecting the presence or absence of one or more analytes with one or more sensing layers and one or more control layers and additional layers (see paragraph 0018 and paragraph 0056 and Fig. 2) wherein a material that is substantially impermeable to liquids is described to be a polyolefin in a nonwoven web (see paragraph 0072).
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 Smith and Hershcovitz-Fundoiano with the teachings of Song to have made the transfer layer comprise of a polyolefin layer because it would have resulted in the predictable result of making the transfer layer substantially impermeable to liquids while still having a cloth like feeling (Song: see [0072]).
With respect to claim 8, all limitations of claim 1 apply in which Smith further discloses wherein the absorbent layer comprises an airlaid layer (see col 5 lines 15-29, additional absorbent layer in between the upper outer layer #26 and the lower outer layer #28 which is made of a suitable absorbent hydrophilic fiber).
With respect to claim 11, all limitations of claim 8 apply in which Smith further discloses wherein the density of the airlaid layer is from 200 grams per square meter (GSM) to 750 GSM (see col 5 lines 15-29, additional absorbent layer in between the upper outer layer #26 and the lower outer layer #28 which is made of a suitable absorbent hydrophilic fiber where it is known that the density of DACRON depending on how heavy is needed can have a density over 200 GSM).
With respect to claim 15, all limitations of claim 1 apply in which Hershcovitz-Fundoiano further teaches wherein each of the one or more indicator composition polymers is selected from cellulose, a cellulose ester, and a copolymer thereof (see paragraph 0058-0059, polymers comprises cellulose, cellulose ester or copolymers).
With respect to claim 18, all limitations of claim 1 apply in which Hershcovitz-Fundoiano further teaches wherein the one or more indicator composition polymers comprise cellulose acetate and/or cellulose acetate butyrate (see paragraph 0058, cellulose acetate and/or cellulose acetate butyrate).
With respect to claim 21, all limitations of claim 1 apply in which Hershcovitz-Fundoiano further teaches wherein the non-cyclic plasticizer is a di-C1.16 alkyl ester of a dicarboxylic acid (see paragraph 0066-0068, dicarboxylic acid) or a tri-C1.16 alkyl ester of a tricarboxylic acid.
With respect to claim 23, all limitations of claim 1 apply in which Hershcovitz-Fundoiano further teaches wherein the non-cyclic plasticizer is triethyl citrate (see paragraph 0066-0068, triethyl citrate).
With respect to claim 25, all limitations of claim 1 apply in which Hershcovitz-Fundoiano further teaches wherein the hydrophilic surfactant is selected from a poloxamer, a polysorbate (see paragraph 0074-0078, poloxamer or polysorbate), and ethyl-L-lactate.
With respect to claim 27, all limitations of claim 1 apply in which Hershcovitz-Fundoiano further teaches wherein the hydrophilic surfactant is poloxamer 407 (see paragraph 0074-0078, poloxamer 407).
With respect to claim 30, all limitations of claim 1 apply in which Smith and Hershcovitz-Fundoiano do not specifically teach wherein the C1-16 aliphatic carboxylic acid is citric acid.
Song teaches carboxylic acids being utilized as a reagent (see paragraph 0025: carboxylic acids) where the reagents are present on a layer to detect presence of an analyte (see paragraph 0028-0029). Song further teaches wherein suitable carboxylic acids can be citric acid (see paragraph 0025).
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 Smith and Hershcovitz-Fundoiano with the teachings of Song to have chosen specific types of carboxylic acid because it would have resulted in the predictable result of altering a pH so as to alter the speed of a reaction to inhibit an enzyme-catalyzed substrate reaction such as a nitrite reaction to properly detect the presence or absence of an analyte (Song: see [0018]-[0025]).
With respect to claim 33, all limitations of claim 1 apply in which Hershcovitz-Fundoiano further teaches wherein the ion- balance reagent is selected from di(C6-20 alkyl)dimethyl ammonium chloride, N-methyl-N,N- bis(C6-20 alkanoyloxyethyl)-N-(2-hydroxyethyl) ammonium methylsulfate, vinylbenzyldimethylcocoammonium chloride, methyl trioctyl ammonium chloride, tricaprylylmethyl ammonium chloride, tridodecylmethyl ammonium chloride, and cetyltrimethyl ammonium chloride, or a combination thereof (see paragraph 0092-0094, tridodecylmethyl ammonium, chloride di(long-chain alkyl)dimethyl ammonium chloride, N-methyl-N,N-bis(long-chain alkanoyloxyethyl)-N-(2-hydroxyethyl) ammonium methylsulfate, vinylbenzyldimethylcocoammonium chloride, methyl trioctyl ammonium chloride tricaprylylmethyl ammonium chloride, tridodecylmethyl ammonium chloride and cetyltimethyl ammonium chloride).
With respect to claim 34, all limitations of claim 1 apply in which Hershcovitz-Fundoiano further teaches wherein the ion- balance reagent is tridodecylmethyl ammonium chloride (see paragraph 0092-0094, tridodecylmethyl ammonium chloride).
With respect to claim 37, all limitations of claim 1 apply in which Smith further discloses and Hershcovitz-Fundoiano further teaches wherein the indicator agent is selected from nitrazine yellow (Smith: see col 5 lines 66-67-Col 6 lines 1-10, pH sensitive component #34 which defines a strip such as a strip of NITRAZINE as an indicator agent), cresol red, alizarin, bromocresol purple, chlorophenol red, bromothymol blue, bromoxylenol blue, neutral red, phenol red, thymol blue, xylenol blue or m- cresol purple (Hershcovitz-Fundoiano: see paragraph 0095-0099, nitrazine yellow, cresol red, alizarin, bromocresol purple, chlorophenol red, bromothymol blue, bromoxylenol blue, neutral red, phenol red, thymol blue, xylenol blue and m-cresol purple).
With respect to claim 38, all limitations of claim 1 apply in which Smith further discloses and Hershcovitz-Fundoiano further teaches wherein the indicator agent is nitrazine yellow (Smith: see col 5 lines 66-67-Col 6 lines 1-10, pH sensitive component #34 which defines a strip such as a strip of NITRAZINE as an indicator agent; AND Hershcovitz-Fundoiano: see paragraph 0095-0099, nitrazine yellow).
With respect to claim 41, all limitations of claim 1 apply in which Hershcovitz-Fundoiano further teaches wherein: the one or more indicator composition polymers are cellulose acetate and cellulose acetate butyrate (see paragraph 0058, cellulose acetate and/or cellulose acetate butyrate); the non-cyclic plasticizer is triethyl citrate (see paragraph 0066-0068, triethyl citrate); the hydrophilic surfactant is poloxamer 407 (see paragraph 0074-0078, poloxamer 407); the ion-balance reagent is tridodecylmethyl ammonium chloride (see paragraph 0092-0094, tridodecylmethyl ammonium chloride); and the indicator agent is nitrazine yellow (see paragraph 0095-0099, nitrazine yellow).
Smith and Hershcovitz-Fundoiano do not specifically teach wherein the C1-16 aliphatic carboxylic acid is citric acid.
Song teaches carboxylic acids being utilized as a reagent (see paragraph 0025: carboxylic acids) where the reagents are present on a layer to detect presence of an analyte (see paragraph 0028-0029). Song further teaches wherein suitable carboxylic acids can be citric acid (see paragraph 0025).
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 Smith and Hershcovitz-Fundoiano with the teachings of Song to have chosen specific types of carboxylic acid because it would have resulted in the predictable result of altering a pH so as to alter the speed of a reaction to inhibit an enzyme-catalyzed substrate reaction such as a nitrite reaction to properly detect the presence or absence of an analyte (Song: see [0018]-[0025]).
With respect to claim 42, all limitations of claim 1 apply in which Hershcovitz-Fundoiano further teaches wherein the indicator composition comprises 43.8 wt.% cellulose acetate, 17.5 wt.% cellulose acetate butyrate, 25.0 wt% triethyl citrate, 6.6 wt.% poloxamer 407, 1.2 wt.% tridodecylmethyl ammonium chloride, and 0.53 wt.% nitrazine yellow (see Table 1).
Although Hershcovitz-Fundoiano teaches carboxylic acids (see paragraph 0012-0013, 0021) as part of indicator composition with 5.5 wt. % (see Table 1), Smith and Hershcovitz-Fundoiano do not specifically teach that the carboxylic acid is citric acid.
Song teaches carboxylic acids being utilized as a reagent (see paragraph 0025: carboxylic acids) where the reagents are present on a layer to detect presence of an analyte (see paragraph 0028-0029). Song further teaches wherein suitable carboxylic acids can be citric acid (see paragraph 0025).
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 Smith and Hershcovitz-Fundoiano with the teachings of Song to have chosen a specific types of carboxylic acid because it would have resulted in the predictable result of altering a pH so as to alter the speed of a reaction to inhibit an enzyme-catalyzed substrate reaction such as a nitrite reaction to properly detect the presence or absence of an analyte (Song: see [0018]-[0025]).
With respect to claim 43, all limitations of claim 1 apply in which Hershcovitz-Fundoiano further teaches
wherein the indicator composition consists of cellulose acetate (see paragraph 0058, cellulose acetate and/or cellulose acetate butyrate), cellulose acetate butyrate(see paragraph 0058, cellulose acetate and/or cellulose acetate butyrate), triethyl citrate (see paragraph 0066-0068, triethyl citrate), poloxamer 407 (see paragraph 0074-0078, poloxamer 407), tridodecylmethyl ammonium chloride (see paragraph 0092-0094, tridodecylmethyl ammonium chloride), and nitrazine yellow (see paragraph 0095-0099, nitrazine yellow).
Although Hershcovitz-Fundoiano teaches the indicator composition consists of carboxylic acid (see paragraph 0082-0091), Smith and Hershcovitz-Fundoiano do not specifically teach citric acid.
Song teaches carboxylic acids being utilized as a reagent (see paragraph 0025: carboxylic acids) where the reagents are present on a layer to detect presence of an analyte (see paragraph 0028-0029). Song further teaches wherein suitable carboxylic acids can be citric acid (see paragraph 0025).
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 Smith and Hershcovitz-Fundoiano with the teachings of Song to have chosen specific types of carboxylic acid because it would have resulted in the predictable result of altering a pH so as to alter the speed of a reaction to inhibit an enzyme-catalyzed substrate reaction such as a nitrite reaction to properly detect the presence or absence of an analyte (Song: see [0018]-[0025]).
With respect to claim 44, all limitations of claim 43 apply in which Hershcovitz-Fundoiano further teaches wherein the indicator composition consists of 39-47 wt.% cellulose acetate, 15-20 wt.% cellulose acetate butyrate, 22-28 wt% triethyl citrate, 5-8 wt.% poloxamer 407, 1.15-1.27 wt.% tridodecylmethyl ammonium chloride, and 0.48-0.6 wt.% nitrazine yellow (see Table 1).
Although Hershcovitz-Fundoiano teaches carboxylic acids (see paragraph 0012-0013, 0021) as part of indicator composition with 5-8 wt. % (see Table 1), Smith and Hershcovitz-Fundoiano do not specifically teach that the carboxylic acid is citric acid.
Song teaches carboxylic acids being utilized as a reagent (see paragraph 0025: carboxylic acids) where the reagents are present on a layer to detect presence of an analyte (see paragraph 0028-0029). Song further teaches wherein suitable carboxylic acids can be citric acid (see paragraph 0025).
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 Smith and Hershcovitz-Fundoiano with the teachings of Song to have chosen a specific types of carboxylic acid because it would have resulted in the predictable result of altering a pH so as to alter the speed of a reaction to inhibit an enzyme-catalyzed substrate reaction such as a nitrite reaction to properly detect the presence or absence of an analyte (Song: see [0018]-[0025]).
With respect to claim 46, all limitations of claim 1 apply in which Smith and Hershcovitz-Fundoiano further teaches wherein: the membrane layer comprises a nonwoven polypropylene layer (Smith: see col 4 lines 46-47 and lines 57-60: non-woven polypropylene; and see col 4 lines 50-57, the upper outer layer #26 can be made from any of the material conventional for the use of being compliant, soft feeling that is non-irritating to the parts of user’s skin with which it is in contact) and a hydrophilic coating disposed thereon (Smith: see col 4 lines 50-57, the upper outer layer #26 can be made from any of the material conventional for the use of being compliant, soft feeling that is non-irritating to the parts of user’s skin with which it is in contact; and see col 5 lines 20-29, hydrophilic fiber coating to absorb and contain liquid); […]; and the absorbent layer comprises an airlaid layer comprising a superabsorbent polymer, wherein the density of the airlaid layer is from 200 GSM to 350 GSM (Smith: see col 5 lines 15-29, additional absorbent layer in between the upper outer layer #26 and the lower outer layer #28 which is made of a suitable absorbent hydrophilic fiber where it is known that the density of DACRON depending on how heavy is needed can have a density over 200 GSM), and further wherein: the transfer layer comprises an indicator composition disposed thereon (Hershcovitz-Fundoiano: see paragraph 0021, indicator composition), comprising 39-47 wt.% cellulose acetate, 15-20 wt.% cellulose acetate butyrate, 22-28 wt% triethyl citrate, 5-8 wt.% poloxamer 407, 1.15-1.27 wt.% tridodecylmethyl ammonium chloride, and 0.48-0.6 wt.% nitrazine yellow (Hershcovitz-Fundoiano: see Table 1).
Smith further discloses wherein the transfer layer comprises a strip of flexible material (see col 5 lines 66-67) however Smith and Hershcovitz-Fundoiano do not specifically disclose wherein the transfer layer comprises a woven polyolefin layer or a nonwoven polyolefin layer. Although Hershcovitz-Fundoiano teaches carboxylic acids (see paragraph 0012-0013, 0021) as part of indicator composition with 5-8 wt. % (see Table 1), Smith and Hershcovitz-Fundoiano do not specifically teach that the carboxylic acid is citric acid.
Song teaches a multilayered device for detecting the presence or absence of one or more analytes with one or more sensing layers and one or more control layers and additional layers (see paragraph 0018 and paragraph 0056 and Fig. 2) wherein a material that is substantially impermeable to liquids is described to be a polyolefin in a nonwoven web (see paragraph 0072). Song teaches carboxylic acids being utilized as a reagent (see paragraph 0025: carboxylic acids) where the reagents are present on a layer to detect presence of an analyte (see paragraph 0028-0029). Song further teaches wherein suitable carboxylic acids can be citric acid (see paragraph 0025).
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 Smith and Hershcovitz-Fundoiano with the teachings of Song to have made the transfer layer comprise of a polyolefin layer because it would have resulted in the predictable result of making the transfer layer substantially impermeable to liquids while still having a cloth like feeling (Song: see [0072]) and to have chosen a specific types of carboxylic acid because it would have resulted in the predictable result of altering a pH so as to alter the speed of a reaction to inhibit an enzyme-catalyzed substrate reaction such as a nitrite reaction to properly detect the presence or absence of an analyte (Song: see [0018]-[0025]).
With respect to claim 47, all limitations of claim 46 apply in which Smith and Hershcovitz-Fundoiano further teaches wherein: the membrane layer comprises a nonwoven polypropylene layer (Smith: see col 4 lines 46-47 and lines 57-60: non-woven polypropylene; and see col 4 lines 50-57, the upper outer layer #26 can be made from any of the material conventional for the use of being compliant, soft feeling that is non-irritating to the parts of user’s skin with which it is in contact) and a hydrophilic coating disposed thereon (Smith: see col 4 lines 50-57, the upper outer layer #26 can be made from any of the material conventional for the use of being compliant, soft feeling that is non-irritating to the parts of user’s skin with which it is in contact; and see col 5 lines 20-29, hydrophilic fiber coating to absorb and contain liquid); […]; and the absorbent layer comprises an airlaid layer comprising a superabsorbent polymer, wherein the density of the airlaid layer is from 200 GSM to 350 GSM (Smith: see col 5 lines 15-29, additional absorbent layer in between the upper outer layer #26 and the lower outer layer #28 which is made of a suitable absorbent hydrophilic fiber where it is known that the density of DACRON depending on how heavy is needed can have a density over 200 GSM), and further wherein: the transfer layer comprises an indicator composition disposed thereon (Hershcovitz-Fundoiano: see paragraph 0021, indicator composition), comprising 43.8 wt.% cellulose acetate, 17.5 wt.% cellulose acetate butyrate, 25.0 wt% triethyl citrate, 6.6 wt.% poloxamer 407, 1.2 wt.% tridodecylmethyl ammonium chloride, and 0.53 wt.% nitrazine yellow (Hershcovitz-Fundoiano: see Table 1).
Smith further discloses wherein the transfer layer comprises a strip of flexible material (see col 5 lines 66-67) however Smith and Hershcovitz-Fundoiano do not specifically disclose wherein the transfer layer comprises a woven polyolefin layer or a nonwoven polyolefin layer. Although Hershcovitz-Fundoiano teaches carboxylic acids (see paragraph 0012-0013, 0021) as part of indicator composition with 5.5 wt. % (see Table 1), Smith and Hershcovitz-Fundoiano do not specifically teach that the carboxylic acid is citric acid.
Song teaches a multilayered device for detecting the presence or absence of one or more analytes with one or more sensing layers and one or more control layers and additional layers (see paragraph 0018 and paragraph 0056 and Fig. 2) wherein a material that is substantially impermeable to liquids is described to be a polyolefin in a nonwoven web (see paragraph 0072). Song teaches carboxylic acids being utilized as a reagent (see paragraph 0025: carboxylic acids) where the reagents are present on a layer to detect presence of an analyte (see paragraph 0028-0029). Song further teaches wherein suitable carboxylic acids can be citric acid (see paragraph 0025).
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 Smith and Hershcovitz-Fundoiano with the teachings of Song to have made the transfer layer comprise of a polyolefin layer because it would have resulted in the predictable result of making the transfer layer substantially impermeable to liquids while still having a cloth like feeling (Song: see [0072]) and to have chosen a specific types of carboxylic acid because it would have resulted in the predictable result of altering a pH so as to alter the speed of a reaction to inhibit an enzyme-catalyzed substrate reaction such as a nitrite reaction to properly detect the presence or absence of an analyte (Song: see [0018]-[0025]).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Smith in view of Hershcovitz-Fundoiano and Song as applied to claim 1 above, and further in view of Kritzman (US 20030166293 A1; previously cited).
With respect to claim 5, all limitations of claim 1 apply in which Smith, Hershcovitz-Fundoiano and Song do not specifically teach wherein the hydrophilic coating comprises a cationic surfactant.
Kritzman teaches a secretion monitoring article for identifying a secreted biological fluid (see paragraph 0037) with layers (see paragraph 0152 and see Fig. 3) where an indicator substrate is added as a layer (see paragraph 0152-0154, a surfactant solution with a cationic function group can be used).
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 Smith, Hershcovitz-Fundoiano and Song to have used a cationic surfactant as a hydrophilic coating because it would have resulted in the predictable result of attaching a negatively charged indicator (Kritzman: [0154]-[0155]) to not mix with other indicators present in the article (Kritzman: see [0061]).
Conclusion
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/N.N.P./Examiner, Art Unit 3791
/MATTHEW KREMER/Primary Examiner, Art Unit 3791
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