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 .
The amendment filed January 28, 2026 has been received and entered. With the entry of the amendment, claims 1-20 and new claim 21 are pending for examination.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120, 121, 365(c), or 386(c) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 17/258,789, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
17/258,789 does not provide support for the use of curcumin or starch as provided in the present claims. Therefore, priority does not extend past August 16, 2024 (when provisional application 63/684,137 was filed).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 12 and 21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 12,”upon contact with at least 5” micrograms of the opioid is not supported by the disclosure as filed, and therefore, the claim contains new matter.
Claim 21, has “wherein no pH-induced color change occurs in the absence of the opioid within a pH range of 5-9”. However, there is no support for these limitations. Applicant refers to color change/deprotonation at pH level of 9 and above. It is not indicated that color change cannot occur at less than 9, at least to some degree. Therefore, the claim contains new matter.
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 1-21 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1, 11 and 16, now refer to tested for “an illicit substance”, with the surface containing a specific opioid. However, as worded, it is unclear if the illicit substance being tested for is the specific opioid. For the purpose of examination, it is understood that the illicit substance is the selected opioid, however, applicant should clarify what is intended, without adding new matter.
Claim 21, “an amine-containing opioid” is confusing and indefinite as worded as to whether the “opioids” listed in claim 16 would be that referred to, or different opioids referred to. If different, at line 4, when “the opioid” is referred to, it could be that in claim 16 or that in claim 21. For the purpose of examination, it is understood that the “amine-containing opioid” would be one of the opioids listed in claim 16, however, applicant should clarify what is intended, without adding new matter.
The dependent claims do not cure the defects of the claims from which they depend and are therefore also rejected.
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.
Claims 1, 3-14 and 16-21 are rejected under 35 U.S.C. 103 as being unpatentable over Benson et al (US 2445994) in view of Cayle et al (US 3595754) and Miyamoto et al (US 2019/0200660), EITHER alone OR further in view of Jelonek et al (US 2012/0093736).
Claim 1: Benson teaches providing a coated fabric/cloth (washcloth) article with a color changing indication (where a color changing indication occurs based on pH of material contacting the wet cloth) (note column 1, lines 20-45, column 2, lines 25-50). To provide the article, the fabric/cloth has a portion dyed with a dilute solution (so the cloth/fabric would be wetted with the dilute solution), where the dilute solution contains curcumin, which provides the color changing material (note column 1, lines 35-50). It is desired for the dye to have an affinity to the fabric to withstand repeated rubbings, washing and rinsings (note claim 1, with cotton fabric).
(A) As to the solution used for dying the fabric having the steps of combining the curcumin with alcohol to produce a curcumin solution, combining starch with water to provide a starch suspension, combining the starch suspension and the curcumin solution to provide a curcumin-starch suspension or solution, and then using the curcumin-starch suspension or solution to wet the cloth/fabric,
Cayle teaches how fabric can be coated/impregnated with a coloring material that includes an organic or inorganic pigment in finely divided form, and where starch is used to bind the pigment to the fabric (note column 1, lines 10-15, column 1, line 70 to column 2, line 20). The fabric can be cotton (column 2, lines 35-40). The treated fabric can be washed without a major loss of pigmentation (as long as not treated with formulation with significant amylase activity) (column 2, lines 10-20). In a description of the coating of the fabric, example pigment (lampblack) is combined with methanol (forming a pigment-alcohol suspension/solution), starch is combined with water giving a starch solution/suspension, and then the pigment solution/suspension is combined with the starch solution/suspension to form a pigment-starch solution/suspension and fabric is wetted with this solution to provide the coated fabric (note column 2, lines 45-70). The pigment-starch solution can be considered dilute as there can be much more water than other ingredients (note column 2, lines 45-60).
Miyamoto indicates how curcumin can be considered a pigment (note 0004), and how curcumin can be provided in a composition/solution/suspension for use (note 0006-0009), where the solution can include curcumin, modified starch, and water and also gum Arabic (which can provide emulsion stability and adhesiveness, 0059) (note 0036-0037), and where the solution can also contain alcohols (0146). The ingredients are combined together and mixed, etc. to provide a suspension of the materials (note 0166-0171). The pigment-starch suspension/solution can be considered dilute as there can be much more water than other ingredients (note 0144, note Table 7, for example).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Benson to provide the solution used for dying the fabric having the steps of combining the curcumin with alcohol to produce a curcumin solution, combining starch with water to provide a starch suspension, combining the starch suspension and the curcumin solution to product a curcumin-starch suspension or solution, and then using the curcumin-starch suspension or solution to wet the cloth/fabric as suggested by Cayle and Miyamoto to provide a desirable way to apply and fix the curcumin, since Benson indicates to provide a dilute solution of the curcumin to act as the dye for the fabric, and Cayle shows that it is known to attach pigment to cloth by using a solution with the pigment and starch to bind the pigment, where the solution can also have alcohol, and has the steps of combining the pigment with alcohol to produce a pigment solution, combining starch with water to provide a starch suspension, combining the starch suspension and the pigment solution to produce a pigment-starch suspension or solution, and then using the pigment-starch suspension or solution to wet the cloth/fabric, where Miyamoto indicates how curcumin is a known pigment, and Benson indicates how it is known to be desired to be attached to cloth, and Miyamoto also teaches that it is known to conventionally provide curcumin in solutions with water, curcumin, starch and alcohol to provide suspensions for use, and thus it would be expected that the curcumin of Miyamoto would be predicably and acceptably provided as a pigment in the process with the steps as described by Cayle to apply to fabric as desired by Benson.
Benson in view of Cayle and Miyamoto can be considered as providing a wet wipe to the extent claimed because (1) all that is described being needed to provide such a wet wipe are the claimed steps outside to the preamble to the claim, all of which are provided by the combination of references, (2) the treated cloth of Benson is described as having its color changing features when wet, that is when used as a wet wipe to the extent claimed (note column 1, lines 25-45, column 2, lines 15-20, when a specifically wiping action is described). Optionally, further using Jelonek, Jelonek further describes how it can be desirable to provide fabric wipes that can be made from cotton, etc. (note 0016), where the wipes are to have impregnated sanitizer solution (giving wet wipes) (note 0008), and where the wipes are provided with a reversable color changing dye/ink treatment, where the color changes due to pH, indicating when sanitizer depleted (note 0018-0022), where the ink solution can include water and alcohol (note 0027). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Benson in view of Cayle and Miyamoto to also use the treated cloth to form wet wipes that would hold sanitizer as suggested by Jelonek with an expectation of predictably acceptable results, because Benson in view of Cayle and Miyamoto would provide a curcumin treated cloth that can be wetted and indicate changes in pH and Jelonek would indicate that such a pH indicating treated cloth would be desirable for forming sanitizer impregnated wet wipes.
(B) As to the wetted fabric configured to (i) contact a surface to be tested for an illicit substance (opioids as listed) and (ii) exhibit a visible color change within about thirty seconds from when the wetted fabric contacts the surface, where the surface contains an opioid selected from fentanyl, carfentanyl, heroin, oxycodone, morphine, or combinations thereof,
As worded in the claim, this appears to be merely an intended use of the fabric, where the fabric just has to be capable of contacting the surface to be tested and exhibit the visible color change within about 30 seconds from contact the surface that contains a listed opioid, since there are no actual required steps of actually contacting the wetted fabric with the surface with opioids as claimed or exhibiting the visible color change as claimed. Here, since the same providing of curcumin to the surface from the starch-curcumin solution as claimed to wet the fabric as claimed, it is also understood that the fabric is configured to contact a surface and where if this surface contains the claimed opioids would react to give the visible color change within about 30 seconds from contact. Note Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). Note in Benson, the cloth/fabric would contact a surface in use (such as a face, note column 2, lines15-20, or soap, column 2, lines 1-5). Additionally, when using Jelonek as to the suggestion to form wet wipes, such wipes would also contact a surface in use (note 0008).
Claims 3, 4: As to the ratio of the amount of curcumin to alcohol, Cayle describes using a somewhat larger amount of pigment to alcohol ratio in the example (note column 2,lines 45-55). However, Miyamoto describes that when providing curcumin and alcohol in the composition (note 0166), the amount of alcohol can be 10 to 1000 parts by mass per 100 parts of curcumin (note 0150), giving a ratio of curcumin:alcohol of 100:10-1000 by weight, indicating a variable concentration. Therefore, based on the specific alcohol used, it would have been obvious to optimize the amount, giving a value in the claimed range. Note as discussed in MPEP 2144.05(II)(A):
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.)
Claims 5: As to the temperature for producing the curcumin solution, Cayle gives no temperature limitation for producing the pigment (curcumin as suggested by Miyamoto) solution (note column 2, lines 45-55), and thus it would be suggested that room temperature, in the claimed range, could be used as the most efficient temperature to use. Additionally, Miyamoto describes combining the materials at a temperature range of 0-100 degrees C (note 0166) also suggesting that room temperature would be acceptably used from optimization of the temperature. Note as discussed in MPEP 2144.05(II)(A):
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.)
Claims 6-9: As to the ratio of starch and water as combined: Cayle gives an example of using 50 g of starch to 950 ml of water or about 52.6 g starch:liter of water (column 2,lines 45-55), which would be in the range of claims 6, 7 and also 8 (noting “about”). Furthermore, in Miyamoto, the amount of water can be 50—5000 parts per mass to 100 parts by mass of gum arabic (note 0144) and the amount of starch can be 0.5 to 300 parts by mass to 100 parts gum arabic (note 0142), further indicating to optimize the amount of starch and water, giving values in the claimed range. Note as discussed in MPEP 2144.05(II)(A):
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.)
Claim 10: the temperature for producing the curcumin solution would be suggested to be the claimed range as discussed for claim 5 above.
Claim 11: Benson teaches providing a coated fabric/cloth (washcloth) article with a color changing indication (where a color changing indication occurs based on pH of material contacting the wet cloth) (note column 1, lines 20-45, column 2, lines 25-50). To provide the article, the fabric/cloth has a portion dyed with a dilute solution (so the cloth/fabric would be wetted with the dilute solution), where the dilute solution contains curcumin, which provides the color changing material (note column 1, lines 35-50). It is desired for the dye to have an affinity to the fabric to withstand repeated rubbings, washing and rinsings (note claim 1, with cotton fabric).
(A) As to the solution used for dying the fabric having the steps of combining curcumin powder and starch powder to form a powder mix, combining the powder mix with alcohol to form an alcoholic solution, combining the alcoholic solution with water (claim 12), and then using the solution to wet the cloth/fabric,
Cayle teaches how fabric can be coated/impregnated with a coloring material that includes an organic or inorganic pigment in finely divided form (so powder form), and where starch is used to bind the pigment to the fabric (note column 1, lines 10-15, column 1, line 70 to column 2, line 20). The fabric can be cotton (column 2, lines 35-40). The treated fabric can be washed without a major loss of pigmentation (as long as not treated with formulation with significant amylase activity) (column 2, lines 10-20). In a description of the coating of the fabric, example pigment (lampblack) is combined with methanol (forming a pigment-alcohol suspension/solution), starch is combined with water giving a starch solution/suspension, and then the pigment solution/suspension is combined with the starch solution/suspension to form a pigment-starch solution/suspension and fabric is wetted with this solution to provide the coated fabric (note column 2, lines 45-70). The pigment-starch solution/suspension can be considered dilute as there is much more water than other ingredients (note column 2, lines 45-60). It is understood that the starch can be provided as powder (since granules are described) (note column 2, lines 30-40).
Miyamoto indicates how curcumin can be considered a pigment (note 0004), and how curcumin can be provided in a composition/solution/suspension for use (note 0006-0009), where the solution can include curcumin, modified starch, and water and also gum Arabic (which can provide emulsion stability and adhesiveness, 0059) (note 0036-0037), and where the solution can also contain alcohols (0146). The ingredients are combined together and mixed, etc. to provide a suspension of the materials (note 0166-0171). The curcumin used can be in powder form (note 0053-0055). The pigment-starch solution can be considered dilute as there can be much more water than other ingredients (note 0144, note Table 7, for example).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Benson to provide the solution used for dying the fabric having the steps of combining curcumin powder and starch powder to form a powder mix, combining the powder mix with alcohol to form an alcoholic solution, combining the alcoholic solution with water (claim 12), and then using the solution to wet the cloth/fabric as suggested by Cayle and Miyamoto to provide a desirable way to apply and fix the curcumin, since Benson indicates to provide a dilute solution of the curcumin to act as the dye for the fabric, and Cayle shows that it is known to attach pigment to cloth by using a combined solution with the pigment and starch, alcohol and water, and using the combination to wet the cloth/fabric, where it is indicated that starch and pigment can be provided as powders, Miyamoto indicates how curcumin is a known pigment that can be in powder form and Benson indicates how it is known to be desired to be attached to cloth, and Miyamoto also teaches that it is known to conventionally provide curcumin in solutions with water, curcumin, starch and alcohol to provide suspensions for use, where as to the order of combining ingredients to get first combining curcumin powder and starch, then combining with alcohol to get an alcoholic solution, then combining with water to get the solution to apply to fabric as desired by Benson, as indicated by In re Gibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930), Selection of any order of mixing ingredients is prima facie obvious.
Benson in view of Cayle and Miyamoto can be considered as providing a wet wipe to the extent claimed because (1) all that is described being needed to provide such a wet wipe are the claimed steps outside to the preamble to the claim, all of which are provided by the combination of references, (2) the treated cloth of Benson is described as having its color changing features when wet, that is when used as a wet wipe to the extent claimed (note column 1, lines 25-45, column 2, lines 15-20, when a specifically wiping action is described). Optionally, further using Jelonek, Jelonek further describes how it can be desirable to provide fabric wipes that can be made from cotton, etc. (note 0016), where the wipes are to have impregnated sanitizer solution (giving wet wipes) (note 0008), and where the wipes are provided with a reversable color changing dye/ink treatment, where the color changes due to pH, indicating when sanitizer depleted (note 0018-0022), where the ink solution can include water and alcohol (note 0027). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Benson in view of Cayle and Miyamoto to also use the treated cloth to form wet wipes that would hold sanitizer as suggested by Jelonek with an expectation of predictably acceptable results, because Benson in view of Cayle and Miyamoto would provide a curcumin treated cloth that can be wetted and indicate changes in pH and Jelonek would indicate that such a pH indicating treated cloth would be desirable for forming sanitizer impregnated wet wipes.
(B) As to the wetted fabric configured to (i) contact a surface to be tested for an illicit substance (opioids as listed) and (ii) exhibit a visible color change within about thirty seconds from when the wetted fabric contacts the surface, where the surface contains an opioid selected from fentanyl, carfentanyl, heroin, oxycodone, morphine, or combinations thereof,
As worded in the claim, this appears to be merely an intended use of the fabric, where the fabric just has to be capable of contacting the surface to be tested and exhibit the visible color change within about 30 seconds from contact the surface that contains a listed opioid, since there are no actual required steps of actually contacting the wetted fabric with the surface with opioids as claimed or exhibiting the visible color change as claimed. Here, since the same providing of curcumin to the surface from the starch-curcumin solution as claimed to wet the fabric as claimed, it is also understood that the fabric is configured to contact a surface and where if this surface contains the claimed opioids would react to give the visible color change within about 30 seconds from contact. Note Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). Note in Benson, the cloth/fabric would contact a surface in use (such as a face, note column 2, lines15-20, or soap, column 2, lines 1-5). Additionally, when using Jelonek as to the suggestion to form wet wipes, such wipes would also contact a surface in use (note 0008).
Claim 12: as to combining the alcoholic solution with water, this would be suggested as discussed for claim 11 above. As to the alcoholic solution containing the amounts claimed of curcumin and starch, Miyamoto notes to provide 100 parts by mass of curcumin to 0.5-100 parts by mass of starch (note 0141), and the amount of starch can be 0.05-30 mass% of the composition (note 0143) which would also have water (note 0144) and alcohol (note 0146), and it would have been obvious to optimize the amounts (including weight/volume) of each, which would give values in the claimed range. Note as discussed in MPEP 2144.05(II)(A):
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.)
Furthermore, as to this undergoing a color transition in the time listed as claimed upon contact, this would be understood to occur due to the same materials in the same amount claimed being provided. Note that as worded, contact is not actually required to occur. Note Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977).
Claims 13, 14: as to the weight ratio of curcumin to starch, Miyamoto notes to provide 100 parts by mass of curcumin to 0.5-100 parts by mass of starch (note 0141), which overlaps the claimed range, and it would have been obvious to optimize from this range giving a value in the claimed range. Note as discussed in MPEP 2144.05(II)(A):
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.)
Claim 16: Benson teaches providing a coated fabric/cloth (washcloth) article with a color changing indication (where a color changing indication occurs based on pH of material contacting the wet cloth) (note column 1, lines 20-45, column 2, lines 25-50). To provide the article, the fabric/cloth has a portion dyed with a dilute solution (so the cloth/fabric would be wetted with the dilute solution), where the dilute solution contains curcumin, which provides the color changing material (note column 1, lines 35-50). It is desired for the dye to have an affinity to the fabric to withstand repeated rubbings, washing and rinsings (note claim 1, with cotton fabric).
(A) As to the solution used for dying the fabric having the steps of combining the curcumin with alcohol to produce a curcumin solution, combining starch with the curcumin solution to provide a curcumin-starch alcoholic suspension or solution, then combining the curcumin-starch alcoholic suspension or solution with water to provide a curcumin-starch solution or suspension, and then using the curcumin-starch suspension or solution to wet the cloth/fabric,
Cayle teaches how fabric can be coated/impregnated with a coloring material that includes an organic or inorganic pigment in finely divided form, and where starch is used to bind the pigment to the fabric (note column 1, lines 10-15, column 1, line 70 to column 2, line 20). The fabric can be cotton (column 2, lines 35-40). The treated fabric can be washed without a major loss of pigmentation (as long as not treated with formulation with significant amylase activity) (column 2, lines 10-20). In a description of the coating of the fabric, example pigment (lampblack) is combined with methanol (forming a pigment-alcohol suspension/solution), starch is combined with water giving a starch solution/suspension, and then the pigment solution/suspension is combined with the starch solution/suspension to form a pigment-starch solution/suspension and fabric is wetted with this solution to provide the coated fabric (note column 2, lines 45-70). The pigment-starch solution can be considered dilute as there is much more water than other ingredients (note column 2, lines 45-60).
Miyamoto indicates how curcumin can be considered a pigment (note 0004), and how curcumin can be provided in a composition/solution/suspension for use (note 0006-0009), where the solution can include curcumin, modified starch, and water and also gum Arabic (which can provide emulsion stability and adhesiveness, 0059) (note 0036-0037), and where the solution can also contain alcohols (0146). The ingredients are combined together and mixed, etc. to provide a suspension of the materials (note 0166-0171). The pigment-starch solution/suspension can be considered dilute as there can be much more water than other ingredients (note 0144, note Table 7, for example).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Benson to provide the solution used for dying the fabric having the steps of combining the curcumin with alcohol to produce a curcumin solution, combining starch with the curcumin solution to provide a curcumin-starch alcoholic suspension or solution, then combining the curcumin-starch alcoholic suspension or solution with water to provide a curcumin-starch solution or suspension, and then using the curcumin-starch suspension or solution to wet the cloth/fabric as suggested by Cayle and Miyamoto to provide a desirable way to apply and fix the curcumin, since Benson indicates to provide a dilute solution of the curcumin to act as the dye for the fabric, and Cayle shows that it is known to attach pigment to cloth by using a solution with the pigment and starch to bind the pigment, where the solution can also have alcohol, and has the steps of combining the pigment with alcohol to produce a pigment solution, combining starch with water to provide a starch suspension, combining the starch suspension and the pigment solution to produce a pigment-starch suspension or solution, and then using the pigment-starch suspension or solution to wet the cloth/fabric, where Miyamoto indicates how curcumin is a known pigment, and Benson indicates how it is known to be desired to be attached to cloth, and Miyamoto also teaches that it is known to conventionally provide curcumin in solutions with water, curcumin, starch and alcohol to provide suspensions for use, and thus it would be expected that the curcumin of Miyamoto would be predicably and acceptably provided as a pigment in the process to apply to fabric as desired by Benson, where as to the specific order of combining the materials, to get combining the curcumin with alcohol to produce a curcumin solution, combining starch with the curcumin solution to provide a curcumin-starch alcoholic suspension or solution, then combining the curcumin-starch alcoholic suspension or solution with water to provide a curcumin-starch solution or suspension to get the solution to apply to fabric as desired by Benson, as indicated by In re Gibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930), Selection of any order of mixing ingredients is prima facie obvious.
Benson in view of Cayle and Miyamoto can be considered as providing a wet wipe to the extent claimed because (1) all that is described being needed to provide such a wet wipe are the claimed steps outside to the preamble to the claim, all of which are provided by the combination of references, (2) the treated cloth of Benson is described as having its color changing features when wet, that is when used as a wet wipe to the extent claimed (note column 1, lines 25-45, column 2, lines 15-20, when a specifically wiping action is described). Optionally, further using Jelonek, Jelonek further describes how it can be desirable to provide fabric wipes that can be made from cotton, etc. (note 0016), where the wipes are to have impregnated sanitizer solution (giving wet wipes) (note 0008), and where the wipes are provided with a reversable color changing dye/ink treatment, where the color changes due to pH, indicating when sanitizer depleted (note 0018-0022), where the ink solution can include water and alcohol (note 0027). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Benson in view of Cayle and Miyamoto to also use the treated cloth to form wet wipes that would hold sanitizer as suggested by Jelonek with an expectation of predictably acceptable results, because Benson in view of Cayle and Miyamoto would provide a curcumin treated cloth that can be wetted and indicate changes in pH and Jelonek would indicate that such a pH indicating treated cloth would be desirable for forming sanitizer impregnated wet wipes.
(B) As to the wetted fabric configured to (i) contact a surface to be tested for an illicit substance (opioids as listed) and (ii) exhibit a visible color change within about thirty seconds from when the wetted fabric contacts the surface, where the surface contains an opioid selected from fentanyl, carfentanyl, heroin, oxycodone, morphine, or combinations thereof,
As worded in the claim, this appears to be merely an intended use of the fabric, where the fabric just has to be capable of contacting the surface to be tested and exhibit the visible color change within about 30 seconds from contact the surface that contains a listed opioid, since there are no actual required steps of actually contacting the wetted fabric with the surface with opioids as claimed or exhibiting the visible color change as claimed. Here, since the same providing of curcumin to the surface from the starch-curcumin solution as claimed to wet the fabric as claimed, it is also understood that the fabric is configured to contact a surface and where if this surface contains the claimed opioids would react to give the visible color change within about 30 seconds from contact. Note Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). Note in Benson, the cloth/fabric would contact a surface in use (such as a face, note column 2, lines15-20, or soap, column 2, lines 1-5). Additionally, when using Jelonek as to the suggestion to form wet wipes, such wipes would also contact a surface in use (note 0008).
Claim 17, 19: as to the curcumin solution comprising the claimed amounts of curcumin and alcohol, Cayle describes using a somewhat larger amount of pigment to alcohol ratio in the example (note column 2,lines 45-55). However, Miyamoto describes that when providing curcumin and alcohol in the composition (note 0166), the amount of alcohol can be 10 to 1000 parts by mass per 100 parts of curcumin (note 0150), giving a ratio of curcumin:alcohol of 100:10-1000 by weight, indicating a variable concentration. Therefore, based on the specific alcohol used, it would have been obvious to optimize the amount, giving a value in the claimed range. Note as discussed in MPEP 2144.05(II)(A):
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.)
Claims 18, 20:as to the amount of starch and alcohol in the curcumin-starch alcoholic suspension or solution, Miyamoto indicates that the amount of starch can be 0.5-100 parts by mass to 100 parts curcumin (note 0141) and the amount of alcohol can be 10-1000 parts by mass per 100 parts curcumin (note 0150), indicating the optimize the amount of each, which would give a value in the claimed range. Note as discussed in MPEP 2144.05(II)(A):
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.).
Claim 21: As to the turning wine red within 5 seconds of exposure to an amine containing opioid, with no pH induced color change occurring in the absence of the opioid within a pH range of 5-9, it is understood that such would occur to the extent claimed due to the same materials as claimed being used. Note Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). Note as worded, the claims do not actually require any such contact.
Claims 2 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Benson in view of Cayle and Miyamoto, EITHER alone OR further in view of Jelonek as applied to claims 1, 3-14 and 16-21 above, and further in view of CN 105040476 (hereinafter ‘476).
Claims 2, 15: as to the alcohol comprising ethanol, Cayle describes using methanol (note column 2, lines 45-55) and Miyamoto describes using polyhydric alcohol (note 0146). Miyamoto notes turmeric comprises curcumin as a yellow main component (note 0002).
‘476 describes providing dyes for preparing pH value color changing fabrics (abstract), where the dyes can be made with turmeric (which would by curcumin containing), and where it is indicated that solutions can be made with this material and the alcohol of ethanol (page 2, translation).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Benson in view of Cayle and Miyamoto, EITHER alone OR further in view of Jelonek to use ethanol in the solutions with the curcumin as suggested by ‘476 with an expectation of predictably acceptable results, since Cayle and Miyamoto would indicate using alcohol in the solutions, and ‘476 indicates ethanol as an acceptable alcohol to use with curcumin containing solutions.
Claims 1-21 are rejected under 35 U.S.C. 103 as being unpatentable over Hull (US 2024/0295571) in view of Yerazunis et al (US 2008/0069727), Cayle et al (US 3595754) and Miyamoto et al (US 2019/0200660).
Claim 1: Hull teaches a method of making a wet wipe used to identify the presence of illicit substances in the form of amine containing opioids such as fentanyl, carfentanyl, heroin, oxycodone, morphine, etc. (note 0011-0012). The substrate can be a fabric wipe, for example (note 0011-0012, 0039), where the fabric can be cotton, polyester, etc. (note 0040). The substrate is provided with a dye that exhibits a visible color change upon exposure to opioid or other amine containing drug (note 0011, 0059). The dye can be applied in the form of a suspension or solution where the dye is suspended in a solvent, where the solvent can be water, ethanol (alcohol)or methanol (alcohol) or a combination thereof, and where the dye mix can contain other possible ingredients, and where the substrate/fabric would then be wetted with the prepared suspension, where the applied suspension can be left moist on the substrate, for example, where the amount of dye is at least that to produce the desired color change in contact with opioid to be detected (note 0061-0067). In use the wetted substrate (which can be fabric) contacts a surface to be tested for an illicit substance/opioid such as fentanyl, etc. and exhibits a visible color change when the surface contains the opioid (note 0012, 0059, 0011), and further where the color change can occur in less than one minute or less than 30 seconds (note 0059), and so is configured to provide these features.
Hull does not specifically teach to use curcumin as the “dye” material, and to provide the curcumin onto the substrate by combining curcumin with alcohol to produce a curcumin solution, combining starch with water to produce a starch suspension and combining the starch suspension with the curcumin solution to provide a curcumin-starch suspension to be applied to the fabric substrate to wet the substrate,
However, Yerazunis describes that curcumin is also a color changing reagent that indicates amines (note 0002), and indicates how curcumin can be applied to a substrate/patch that can be connected to a surface (skin) to color change when the material for color change (here ammonia, for example) is present (note 0007, 0014, 0019), where various dyes can also be used (note 0020).
Cayle teaches how fabric can be coated/impregnated with a coloring material that includes an organic or inorganic pigment in finely divided form, and where starch is used to bind the pigment to the fabric (note column 1, lines 10-15, column 1, line 70 to column 2, line 20). The fabric can be cotton, polyester, etc. (column 2, lines 35-40). The treated fabric can be washed without a major loss of pigmentation (as long as not treated with formulation with significant amylase activity) (column 2, lines 10-20). In a description of the coating of the fabric, example pigment (lampblack) is combined with methanol (forming a pigment-alcohol suspension/solution), starch is combined with water giving a starch solution/suspension, and then the pigment solution/suspension is combined with the starch solution/suspension to form a pigment-starch solution/suspension and fabric is wetted with this solution to provide the coated fabric (note column 2, lines 45-70). The pigment-starch solution can be considered dilute as there can be much more water than other ingredients (note column 2, lines 45-60).
Miyamoto indicates how curcumin can be considered a pigment/colorant (note 0004, 0167), and how curcumin can be provided in a composition/solution/suspension for use (note 0006-0009), where the solution can include curcumin, modified starch, and water and also gum Arabic (which can provide emulsion stability and adhesiveness, 0059) (note 0036-0037), and where the solution can also contain alcohols (0146). The ingredients are combined together and mixed, etc. to provide a suspension of the materials (note 0166-0171). The pigment-starch suspension/solution can be considered dilute as there can be much more water than other ingredients (note 0144, note Table 7, for example).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hull to provide that curcumin is also as the color changing “dye” material that changes color in response to amines as suggested by Yerazunis with an expectation of predictably acceptable results, since Hull indicates to use a color changing dye material that changes color in response to amine presence to indicate the presence of opioids, and Yerazunis further indicates that curcumin is a color changing material that can be used similarly to dyes to indicate the presence of amines. Additionally, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hull in view of Yerazunis to provide that the suspension used for applying the curcumin material to the fabric substrates have the steps of combining the curcumin with alcohol to produce a curcumin solution, combining starch with water to provide a starch suspension, combining the starch suspension and the curcumin solution to product a curcumin-starch suspension or solution, and then using the curcumin-starch suspension or solution to wet the cloth/fabric as suggested by Cayle and Miyamoto to provide a desirable way to apply and fix the curcumin, since Hull indicates to provide a suspension of the dying material including with water and alcohol to act as the dye for the fabric, and Cayle shows that it is known to attach pigment to cloth by using a solution with the pigment and starch to bind the pigment, where the solution can also have alcohol, and has the steps of combining the pigment with alcohol to produce a pigment solution, combining starch with water to provide a starch suspension, combining the starch suspension and the pigment solution to produce a pigment-starch suspension or solution, and then using the pigment-starch suspension or solution to wet the cloth/fabric, where Miyamoto indicates how curcumin is a known pigment, and Hull indicates it is desired to attach the indicating material to fabric/cloth, and Miyamoto also teaches that it is known to conventionally provide curcumin in solutions with water, curcumin, starch and alcohol to provide suspensions for use, and thus it would be expected that the curcumin of Miyamoto would be predicably and acceptably provided as a pigment in the process with the steps as described by Cayle to apply to fabric as desired by Hull in view of Yerazunis.
As to the wetted fabric configured exhibit a visible color change within about thirty seconds from when the wetted fabric contacts the surface, where the surface contains an opioid selected from fentanyl, carfentanyl, heroin, oxycodone, morphine, or combinations thereof, as noted above Hull indicates that the color change can occur in less than 30 seconds, with Yerazunis indicated curcumin as a similar color changing material, and since curcumin is used as claimed, it is understood that it would provide the claimed speed of color change, Note Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977).
Claim 2: As to the use of ethanol, Hull teaches it as an alcohol that can be used in the suspension similarly to methanol as a solvent (note 0063), Cayle describes using methanol (note column 2, lines 45-55), and thus, ethanol would be expected to be acceptably used as a solvent.
Claims 3, 4: As to the ratio of the amount of curcumin to alcohol, Cayle describes using a somewhat larger amount of pigment to alcohol ratio in the example (note column 2,lines 45-55). However, Miyamoto describes that when providing curcumin and alcohol in the composition (note 0166), the amount of alcohol can be 10 to 1000 parts by mass per 100 parts of curcumin (note 0150), giving a ratio of curcumin:alcohol of 100:10-1000 by weight, indicating a variable concentration. Hull indicates to provide the material/dye in amounts sufficient to produce the change in color in response to the opioids (note 0067). Therefore, based on the specific alcohol used, it would have been obvious to optimize the amount, giving a value in the claimed range. Note as discussed in MPEP 2144.05(II)(A):
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.)
Claim 5: As to the temperature for producing the curcumin solution, Cayle gives no temperature limitation for producing the pigment (curcumin as suggested by Miyamoto) solution (note column 2, lines 45-55), and thus it would be suggested that room temperature, in the claimed range, could be used as the most efficient temperature to use. Additionally, Miyamoto describes combining the materials at a temperature range of 0-100 degrees C (note 0166) also suggesting that room temperature would be acceptably used from optimization of the temperature. Note as discussed in MPEP 2144.05(II)(A):
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.)
Claims 6-9: As to the ratio of starch and water as combined: Cayle gives an example of using 50 g of starch to 950 ml of water or about 52.6 g starch:liter of water (column 2,lines 45-55), which would be in the range of claims 6, 7 and also 8 (noting “about”). Furthermore, in Miyamoto, the amount of water can be 50—5000 parts per mass to 100 parts by mass of gum arabic (note 0144) and the amount of starch can be 0.5 to 300 parts by mass to 100 parts gum arabic (note 0142), further indicating to optimize the amount of starch and water, giving values in the claimed range. Note as discussed in MPEP 2144.05(II)(A):
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.)
Claim 10: the temperature for producing the curcumin solution would be suggested to be the claimed range as discussed for claim 5 above.
Claim 11: Hull teaches a method of making a wet wipe used to identify the presence of illicit substances in the form of amine containing opioids such as fentanyl, carfentanyl, heroin, oxycodone, morphine, etc. (note 0011-0012). The substrate can be a fabric wipe, for example (note 0011-0012, 0039), where the fabric can be cotton, polyester, etc. (note 0040). The substrate is provided with a dye that exhibits a visible color change upon exposure to opioid or other amine containing drug (note 0011, 0059). The dye can be applied in the form of a suspension or solution where the dye is suspended in a solvent, where the solvent can be water, ethanol (alcohol)or methanol (alcohol) or a combination thereof, and where the dye mix can contain other possible ingredients, and where the substrate/fabric would then be wetted with the prepared suspension, where the applied suspension can be left moist on the substrate, for example, where the amount of dye is at least that to produce the desired color change in contact with opioid to be detected (note 0061-0067). In use the wetted substrate (which can be fabric) contacts a surface to be tested for an illicit substance/opioid such as fentanyl, etc. and exhibits a visible color change when the surface contains the opioid (note 0012, 0059, 0011), and further where the color change can occur in less than one minute or less than 30 seconds (note 0059), and so is configured to provide these features.
As to the use of curcumin as the “dye” material, and the solution used for dying the fabric having the steps of combining curcumin powder and starch powder to form a powder mix, combining the powder mix with alcohol to form an alcoholic solution, combining the alcoholic solution with water (claim 12), and then using the solution to wet the cloth/fabric,
However, Yerazunis describes that curcumin is also a color changing reagent that indicates amines (note 0002), and indicates how curcumin can be applied to a substrate/patch that can be connected to a surface (skin) to color change when the material for color change (here ammonia, for example) is present (note 0007, 0014, 0019), where various dyes can also be used (note 0020).
Cayle teaches how fabric can be coated/impregnated with a coloring material that includes an organic or inorganic pigment in finely divided form (so powder form), and where starch is used to bind the pigment to the fabric (note column 1, lines 10-15, column 1, line 70 to column 2, line 20). The fabric can be cotton (column 2, lines 35-40). The treated fabric can be washed without a major loss of pigmentation (as long as not treated with formulation with significant amylase activity) (column 2, lines 10-20). In a description of the coating of the fabric, example pigment (lampblack) is combined with methanol (forming a pigment-alcohol suspension/solution), starch is combined with water giving a starch solution/suspension, and then the pigment solution/suspension is combined with the starch solution/suspension to form a pigment-starch solution/suspension and fabric is wetted with this solution to provide the coated fabric (note column 2, lines 45-70). The pigment-starch solution/suspension can be considered dilute as there is much more water than other ingredients (note column 2, lines 45-60). It is understood that the starch can be provided as powder (since granules are described) (note column 2, lines 30-40).
Miyamoto indicates how curcumin can be considered a pigment (note 0004), and how curcumin can be provided in a composition/solution/suspension for use (note 0006-0009), where the solution can include curcumin, modified starch, and water and also gum Arabic (which can provide emulsion stability and adhesiveness, 0059) (note 0036-0037), and where the solution can also contain alcohols (0146). The ingredients are combined together and mixed, etc. to provide a suspension of the materials (note 0166-0171). The curcumin used can be in powder form (note 0053-0055). The pigment-starch solution can be considered dilute as there can be much more water than other ingredients (note 0144, note Table 7, for example).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hull to provide that curcumin is also as the color changing “dye” material that changes color in response to amines as suggested by Yerazunis with an expectation of predictably acceptable results, since Hull indicates to use a color changing dye material that changes color in response to amine presence to indicate the presence of opioids, and Yerazunis further indicates that curcumin is a color changing material that can be used similarly to dyes to indicate the presence of amines. Additionally, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hull in view of Yerazunis to provide the solution used for applying to the fabric having the steps of combining curcumin powder and starch powder to form a powder mix, combining the powder mix with alcohol to form an alcoholic solution, combining the alcoholic solution with water (claim 12), and then using the solution to wet the cloth/fabric as suggested by Cayle and Miyamoto to provide a desirable way to apply and fix the curcumin, since Hull indicates to provide a solution of the dye material in water/alcohol solvent to act as the applicator material for the fabric, and Cayle shows that it is known to attach pigment to cloth by using a combined solution with the pigment and starch, alcohol and water, and using the combination to wet the cloth/fabric, where it is indicated that starch and pigment can be provided as powders, Miyamoto indicates how curcumin is a known pigment that can be in powder form and Hull indicates how it is known for the treatment material to be desired to be attached to cloth/fabric, and Miyamoto also teaches that it is known to conventionally provide curcumin in solutions with water, curcumin, starch and alcohol to provide suspensions for use, where as to the order of combining ingredients to get first combining curcumin powder and starch, then combining with alcohol to get an alcoholic solution, then combining with water to get the solution to apply to fabric as desired by Hull and Yerazunis, as indicated by In re Gibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930), Selection of any order of mixing ingredients is prima facie obvious.
As to the wetted fabric configured exhibit a visible color change within about thirty seconds from when the wetted fabric contacts the surface, where the surface contains an opioid selected from fentanyl, carfentanyl, heroin, oxycodone, morphine, or combinations thereof, as noted above Hull indicates that the color change can occur in less than 30 seconds, with Yerazunis indicated curcumin as a similar color changing material, and since curcumin is used as claimed, it is understood that it would provide the claimed speed of color change, Note Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977).
Claim 12: as to combining the alcoholic solution with water, this would be suggested as discussed for claim 11 above. As to the alcoholic solution containing the amounts claimed of curcumin and starch, Miyamoto notes to provide 100 parts by mass of curcumin to 0.5-100 parts by mass of starch (note 0141), and the amount of starch can be 0.05-30 mass% of the composition (note 0143) which would also have water (note 0144) and alcohol (note 0146), and it would have been obvious to optimize the amounts (including weight/volume) of each, which would give values in the claimed range. Note as discussed in MPEP 2144.05(II)(A):
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.)
Furthermore, as to this undergoing a color transition in the time listed as claimed upon contact, this would be understood to occur due to the same materials in the same amount claimed being provided. Note that as worded, contact is not actually required to occur. Note Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977).
Claims 13, 14: as to the weight ratio of curcumin to starch, Miyamoto notes to provide 100 parts by mass of curcumin to 0.5-100 parts by mass of starch (note 0141), which overlaps the claimed range, and it would have been obvious to optimize from this range giving a value in the claimed range. Note as discussed in MPEP 2144.05(II)(A):
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.)
Claim 15: the presence of ethanol would be suggested as discussed for claim 2 above.
Claim 16: Hull teaches a method of making a wet wipe used to identify the presence of illicit substances in the form of amine containing opioids such as fentanyl, carfentanyl, heroin, oxycodone, morphine, etc. (note 0011-0012). The substrate can be a fabric wipe, for example (note 0011-0012, 0039), where the fabric can be cotton, polyester, etc. (note 0040). The substrate is provided with a dye that exhibits a visible color change upon exposure to opioid or other amine containing drug (note 0011, 0059). The dye can be applied in the form of a suspension or solution where the dye is suspended in a solvent, where the solvent can be water, ethanol (alcohol)or methanol (alcohol) or a combination thereof, and where the dye mix can contain other possible ingredients, and where the substrate/fabric would then be wetted with the prepared suspension, where the applied suspension can be left moist on the substrate, for example, where the amount of dye is at least that to produce the desired color change in contact with opioid to be detected (note 0061-0067). In use the wetted substrate (which can be fabric) contacts a surface to be tested for an illicit substance/opioid such as fentanyl, etc. and exhibits a visible color change when the surface contains the opioid (note 0012, 0059, 0011), and further where the color change can occur in less than one minute or less than 30 seconds (note 0059), and so is configured to provide these features.
As to the use of curcumin as the “dye” material, and to the solution used for dying the fabric having the steps of combining the curcumin with alcohol to produce a curcumin solution, combining starch with the curcumin solution to provide a curcumin-starch alcoholic suspension or solution, then combining the curcumin-starch alcoholic suspension or solution with water to provide a curcumin-starch solution or suspension, and then using the curcumin-starch suspension or solution to wet the cloth/fabric, However, Yerazunis describes that curcumin is also a color changing reagent that indicates amines (note 0002), and indicates how curcumin can be applied to a substrate/patch that can be connected to a surface (skin) to color change when the material for color change (here ammonia, for example) is present (note 0007, 0014, 0019), where various dyes can also be used (note 0020).
Cayle teaches how fabric can be coated/impregnated with a coloring material that includes an organic or inorganic pigment in finely divided form, and where starch is used to bind the pigment to the fabric (note column 1, lines 10-15, column 1, line 70 to column 2, line 20). The fabric can be cotton (column 2, lines 35-40). The treated fabric can be washed without a major loss of pigmentation (as long as not treated with formulation with significant amylase activity) (column 2, lines 10-20). In a description of the coating of the fabric, example pigment (lampblack) is combined with methanol (forming a pigment-alcohol suspension/solution), starch is combined with water giving a starch solution/suspension, and then the pigment solution/suspension is combined with the starch solution/suspension to form a pigment-starch solution/suspension and fabric is wetted with this solution to provide the coated fabric (note column 2, lines 45-70). The pigment-starch solution can be considered dilute as there is much more water than other ingredients (note column 2, lines 45-60).
Miyamoto indicates how curcumin can be considered a pigment (note 0004), and how curcumin can be provided in a composition/solution/suspension for use (note 0006-0009), where the solution can include curcumin, modified starch, and water and also gum Arabic (which can provide emulsion stability and adhesiveness, 0059) (note 0036-0037), and where the solution can also contain alcohols (0146). The ingredients are combined together and mixed, etc. to provide a suspension of the materials (note 0166-0171). The pigment-starch solution/suspension can be considered dilute as there can be much more water than other ingredients (note 0144, note Table 7, for example).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hull to provide that curcumin is also as the color changing “dye” material that changes color in response to amines as suggested by Yerazunis with an expectation of predictably acceptable results, since Hull indicates to use a color changing dye material that changes color in response to amine presence to indicate the presence of opioids, and Yerazunis further indicates that curcumin is a color changing material that can be used similarly to dyes to indicate the presence of amines. Additionally, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hull in view of Yerazunis to provide the solution used for dying the fabric having the steps of combining the curcumin with alcohol to produce a curcumin solution, combining starch with the curcumin solution to provide a curcumin-starch alcoholic suspension or solution, then combining the curcumin-starch alcoholic suspension or solution with water to provide a curcumin-starch solution or suspension, and then using the curcumin-starch suspension or solution to wet the cloth/fabric as suggested by Cayle and Miyamoto to provide a desirable way to apply and fix the curcumin, since Hull in view of Yerazunis indicates to provide a solution of the curcumin to act as the dye for the fabric, and Cayle shows that it is known to attach pigment to cloth by using a solution with the pigment and starch to bind the pigment, where the solution can also have alcohol, and has the steps of combining the pigment with alcohol to produce a pigment solution, combining starch with water to provide a starch suspension, combining the starch suspension and the pigment solution to produce a pigment-starch suspension or solution, and then using the pigment-starch suspension or solution to wet the cloth/fabric, where Miyamoto indicates how curcumin is a known pigment, and Hull in view of Yerazunis indicates how it is known to be desired to be attached to cloth, and Miyamoto also teaches that it is known to conventionally provide curcumin in solutions with water, curcumin, starch and alcohol to provide suspensions for use, and thus it would be expected that the curcumin of Miyamoto would be predicably and acceptably provided as a pigment in the process to apply to fabric as desired by Hull, where as to the specific order of combining the materials, to get combining the curcumin with alcohol to produce a curcumin solution, combining starch with the curcumin solution to provide a curcumin-starch alcoholic suspension or solution, then combining the curcumin-starch alcoholic suspension or solution with water to provide a curcumin-starch solution or suspension to get the solution to apply to fabric as desired by Hull, as indicated by In re Gibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930), Selection of any order of mixing ingredients is prima facie obvious.
As to the wetted fabric configured exhibit a visible color change within about thirty seconds from when the wetted fabric contacts the surface, where the surface contains an opioid selected from fentanyl, carfentanyl, heroin, oxycodone, morphine, or combinations thereof, as noted above Hull indicates that the color change can occur in less than 30 seconds, with Yerazunis indicated curcumin as a similar color changing material, and since curcumin is used as claimed, it is understood that it would provide the claimed speed of color change, Note Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977).
Claim 17, 19: as to the curcumin solution comprising the claimed amounts of curcumin and alcohol, Cayle describes using a somewhat larger amount of pigment to alcohol ratio in the example (note column 2,lines 45-55). However, Miyamoto describes that when providing curcumin and alcohol in the composition (note 0166), the amount of alcohol can be 10 to 1000 parts by mass per 100 parts of curcumin (note 0150), giving a ratio of curcumin:alcohol of 100:10-1000 by weight, indicating a variable concentration. Therefore, based on the specific alcohol used, it would have been obvious to optimize the amount, giving a value in the claimed range. Note as discussed in MPEP 2144.05(II)(A):
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.)
Claims 18, 20:as to the amount of starch and alcohol in the curcumin-starch alcoholic suspension or solution, Miyamoto indicates that the amount of starch can be 0.5-100 parts by mass to 100 parts curcumin (note 0141) and the amount of alcohol can be 10-1000 parts by mass per 100 parts curcumin (note 0150), indicating the optimize the amount of each, which would give a value in the claimed range. Note as discussed in MPEP 2144.05(II)(A):
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.).
Claim 21: As to the turning wine red within 5 seconds of exposure to an amine containing opioid, with no pH induced color change occurring in the absence of the opioid within a pH range of 5-9, it is understood that such would occur to the extent claimed due to the same materials as claimed being used. Note Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). Note as worded, the claims do not actually require any such contact.
Miuchi et al (US 2011/0274809) notes combining curcumin with starch and solvents such as water and also alcohol (note 0015, 0025).
Response to Arguments
Applicant's arguments filed January 28, 2026 have been fully considered.
Note the adjustment to the rejections due to the amendments to the claims, including new 35 USC 112 rejections and the new rejections using Hull and Yerazunis along with Cayle and Miyamoto.
Firstly, as to the rejections using Benson as the primary reference, while Benson does not teach the actual use of the wipe to test for opioids, the current claim language as to the wetted fabric configured to (i) contact a surface to be tested for an illicit substance (opioids as listed) and (ii) exhibit a visible color change within about thirty seconds from when the wetted fabric contacts the surface, where the surface contains an opioid selected from fentanyl, carfentanyl, heroin, oxycodone, morphine, or combinations thereof, merely describes an intended use of the product and does not actually require the wipe to be used in this fashion. With the providing of the curcumin coating treatment, it is understood that the wipe is configured to provide the features claimed, as it would be capable of such action due to the presence of the curcumin. This is also true for Cayle and Miyamoto which show how material can be provided in a solution/suspension and applied to a substrate. When used Jelonek also provides the suggestions as discussed.
Furthermore, due to the amendments, a new rejection using Hull as the primary reference is alternatively provided as to the specific suggestion to use curcumin to provide a opioid detecting wet wipe.
Therefore, the rejections above are maintained.
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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/KATHERINE A BAREFORD/Primary Examiner, Art Unit 1718
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