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
This is an office action in response to applicant's arguments and remarks filed on 1/13/2026. Claims 1-7, 9-14, 17, 20, and 55 are pending in the application.
Status of Objections and Rejections
All rejections from the previous office action are maintained.
Response to Arguments
Applicant’s arguments, see Page 5, filed 1/13/2026, with respect to the 112(d) rejections of claims 15-16 and 18-19 have been fully considered and are persuasive. The 112 rejections of 10/14/2025 have been withdrawn.
In response to applicant's arguments on Pages 5-9, filed 1/13/2026, stating that De Wolff (US 2008/0193387) is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, the invention of De Wolff uses the fumed silica in a similar manner to the instant invention. The fumed silica is used as a solid carrier for a liquid composition, where other carrier compositions include sulfoxides, ethoxylates, and plant based surfactants, see [0122]-[0123] and [0139]-[0140] in De Wolff, where the list of potential surfactants is provided in [0048] of the Instant Specification. A person would look to art that teaches the use of fumed silica as a glidant/adsorbent/anticaking agent for a reagent mix, as is required by the instant invention. The problem being solved by the fumed silica in the instant invention appears to be by increasing adsorption of a liquid composition into a dried solid carrier, which is analogous to the cited limitations of De Wolff (see [0123] – [0125], where a liquid is dispensed into a dried carrier.
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.
Claims 1-7, 9-11, 14, 17, 20, and 55 are rejected under 35 U.S.C. 103 as being unpatentable over Callahan (US Patent 9,759,733, cited on 4/21/2022 IDS), and further in view of Lucas et al. (US20160018424) and De Wolff (US 2008/0193387).
Regarding claim 1, Callahan teaches a portable detection kit for identifying the presence of cannabinoids (detection kit for detecting cannabis, see Abstract), comprising:
a colorimetric dye comprising vanillin (color change dye 4, where the dye consists of vanillin, see Claims 3-4),
a catalytic reagent (alkaline salt 2),
a solvent (solvent pre-wetted onto a swab 30, see Col. 7, Lines 46-64 and Col. 8, Lines 16-36), and
a delivery device containing a solvent or solvent mixture including the solvent (swab 30 contains solvent, see Col. 8, Lines 16-36);
wherein the delivery device is configured to deliver a portion of the solvent or solvent mixture to a target residue to form a sample residue (swab 30 delivers solvent to a target to create a sample residue, see Col. 11, Lines 45-50);
wherein the colorimetric dye undergoes a chemical reaction when the sample residue contains a cannabinoid (the color changing dye 4 reacts when the sample contains cannabis, see Col. 11, Lines 45-56); and
wherein the chemical reaction produces a visible color change that corresponds to a predetermined cannabinoid of a plurality of cannabinoids (the reaction occurs when the dye contacts cannabis or a synthetic cannabinoid, see Col. 11, Line 50 – Col. 12, Line 12).
Callahan does not teach that the catalytic reagent comprises p-toluenesulfonic acid or that the composition comprises a surfactant.
However, in the analogous art of apparatuses and methods for detecting cannabinoids in a sample, Lucas et al. teaches a device comprising a test strip with a Duquenois reagent placed thereupon, see [0011], where the dry reagent comprises vanillin and p-toluenesulfonic acid, see [0032], with a further inert solid diluent for the desiccation and stability of the dry reagent, see [0049].
The modification of a device to test for the presence of cannabis to include the use of a Duquenois reagent was known before the effective filing date of the instant invention (see [0009] in Lucas et al.), where the Duquenois reagent is a functional equivalent to the dry reagent composition for detecting cannabis of Callahan. Therefore, it would have been obvious to a person possessing ordinary skill in the art before the effective filing date of the instant application to have substituted the dried reagent composition on a solid support comprising vanillin of Callahan for the Duquenois reagent further comprising p-toluenesulfonic acid and inert diluent composition of Lucas et al. because both compositions were known equivalents for detecting cannabinoids using test strip kits with vanillin. The substitution of compositions would have resulted in the predictable result of detecting cannabis within a target sample using a dried reagent.
Additionally, previously modified Callahan does not teach that the surfactant (inert solid diluent of Lucas et al.) comprises fumed silica.
However, in the analogous art of powdered solutions, De Wolff teaches a composition where liquid is converted to a solid diluent using fumed silica to act as a desiccating carrier for previously liquid compositions as fumed silica is a powdered carrier (see [0123] – [0125] in De Wolff). Accordingly, the prior art references teach that is known that fumed silica is a known functional equivalent for the inert solid diluent and carrier particle for a detection composition.
Therefore, it would have been obvious to a person possessing ordinary skill in the art before the effective filing date of the instant application to have further modified of the inert diluent of modified Callahan to incorporate the fumed silica as exemplified by De Wolff because fumed silica is a known equivalent to an inert solid diluent in the art of powdered detection solutions (see [0123]). The substitution would have resulted in the predictable result of providing a solid carrier and diluent for the colorimetric solution for detecting cannabinoids.
Regarding claim 2, modified Callahan teaches the portable detection kit as in claim 1, wherein the plurality of cannabinoids includes one or more of tetrahydrocannabinol (THC), cannabidiol (CBD), or cannabinol (CBN) (the cannabinoids of the invention include THC, see Col. 2, Lines 54-59, where US 20150017732, incorporated by reference, teaches that THC is a common cannabinoid, see Table 4).
Regarding claim 3, modified Callahan teaches the portable detection kit of claim 1, wherein the delivery device includes an absorbent material (swab 30 comprises absorbent material, see Claim 25).
Regarding claim 4, modified Callahan teaches the portable detection kit of claim 3, wherein the delivery device is a cotton swab that absorbs the solvent or solvent mixture, a pop or snap cotton swab that stores the solvent or solvent mixture in a shaft, or a wipe that absorbs the solvent or solvent mixture (the swab 30 is cotton to absorb the solvent, see Col. 7, Lines 60-64).
Regarding claim 5, modified Callahan teaches the portable detection kit as in claim 3, wherein the colorimetric dye is received by a solid support carrier (the dye 4 is located on the solid support surface 1 of a test paper 10, see Fig. 1 and Col. 7, Lines 46-54) and the absorbent material contains the solvent mixture including the catalytic reagent and the surfactant (after swiping, the modified swab 30 contains the solvent and the salt 2 and would necessarily contain the surfactant, see Col. 11, Lines 45-55), and wherein the solid support carrier and the absorbent material are each enclosed and separated from each other in respective containers (the test strip 10 and swab 30 are housed in separate sachets 40, see Col. 11, Lines 29-40).
Regarding claim 6, modified Callahan teaches the portable detection kit as in claim 5, wherein the solid support carrier is a paper card, a paper sheet, a synthetic paper, or Whatman filter paper (test paper 10, see Fig. 1 and Col. 7, Lines 46-54).
Regarding claim 7, modified Callahan teaches the portable detection kit as in claim 3, wherein the solvent mixture further comprises the colorimetric dye, the catalytic reagent, and the surfactant (upon mixing, the solvent mixture comprises the dye, salt, and the modified surfactant, see Col. 11, Lines 42-56).
Regarding claim 9, modified Callahan teaches the portable detection kit of claim 3, wherein the kit comprises a dry composition of the dry mixture of: Vanillin, p-Toluene Sulfonic Acid, and fumed silica (see Claim 1).
However, the invention does not explicitly teach that the composition comprises 77% w/w vanillin, 18% w/w p-Toluene Sulfonic Acid, and 5% w/w fumed silica.
Before the effective filing date of the claimed invention, there had been a recognized problem or need in the art to solve the problem of determining an exact concentration of a solution to extract the greatest quantity of cannabinoids from said solution, also known as extending the dynamic range of the assay (see [0043] – [0045] in Lucas et al.). There were a finite number of identified and predictable potential solutions to the recognized need or problem as evidenced by Lucas et al. teaching that there are a limited number of potential reagents that are sensitive to cannabinoids at certain concentrations, including the Duquenois-Levine test that comprises vanillin and p-toluenesulfonic acid, with the additional inert diluent, see [0032], [0049], and [0043] – [0045]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to vary each of the concentrations of the reagent constituents as outlined by Lucas et al. in order to extend the dynamic range of cannabinoid concentrations detected within a solution to provide a wider range of assay results. The results would have been predictable, and since Lucas et al. teaches that the test strip can be entirely coated with a visualization reagent, quickly exposed to an acid, and then dried to yield a quantitative assay result, one of ordinary skill in the art would have pursued the known potential solutions with a reasonable expectation of success.
Regarding claim 10, modified Callahan teaches the portable detection kit as in claim 3, wherein the colorimetric dye, the catalytic reagent, and the surfactant are in the form of a dry mixture of powders of the colorimetric dye, the catalytic reagent, and the surfactant (the dye 4 and salt 2 are dried together on the test strip 10, see Fig. 1 and Col. 7, Lines 46-54), and wherein the dry mixture and the absorbent material are each enclosed and separated from each other within respective containers (the test strip 10 and swab 30 are housed in separate sachets 40, see Col. 11, Lines 29-40.
Regarding claim 11, modified Callahan teaches the portable detection kit of claim 1, wherein the delivery device is a non- absorbent container enclosing a solvent mixture including the colorimetric dye, the catalytic reagent, the surfactant, and the solvent (the test strip 10 and swab 30 are housed in separate sachets 40, see Col. 11, Lines 29-40, where the sachets are non-absorbent containers containing the previously modified colorimetric dye, catalytic reagent, surfactant, and the solvent).
Regarding claim 14, modified Callahan teaches the portable detection kit as in claim 1, wherein the colorimetric dye is configured to undergo chemical reaction with the at least one cannabinoid in the form of liquids, gels or solid powders that are pure or admixed with cutting agents (the dye reacts with the cannabinoid in the form of a liquid, gel, or solid, see Col. 11, Lines 42-56).
Regarding claim 17, modified Callahan teaches the portable detection kit as in claim 1, wherein the catalytic reagent increases the rate of appearance of the visible color change resulting from reaction between the colorimetric dye and the one or more predetermined cannabinoids (the alkaline salt intensifies the color reaction between the dye and cannabis, see Col. 8, Lines 44-50).
Regarding claim 20, modified Callahan teaches the portable detection kit as in claim 1, wherein solvent is an alcohol (the solvent comprises isopropyl alcohol, see Col. 8, Lines 22-36).
Regarding claim 55, modified Callahan teaches the portable detection kit of claim 1, wherein the kit comprises a dry composition of the dry mixture of: Vanillin, p-Toluene Sulfonic Acid, and fumed silica (previously mapped in claim 1).
However, the invention does not explicitly teach that the composition comprises 77% w/w vanillin, 18% w/w p-Toluene Sulfonic Acid, and 5% w/w fumed silica.
Before the effective filing date of the claimed invention, there had been a recognized problem or need in the art to solve the problem of determining an exact concentration of a solution to extract the greatest quantity of cannabinoids from said solution, also known as extending the dynamic range of the assay (see [0043] – [0045] in Lucas et al.). There were a finite number of identified and predictable potential solutions to the recognized need or problem as evidenced by Lucas et al. teaching that there are a limited number of potential reagents that are sensitive to cannabinoids at certain concentrations, including the Duquenois-Levine test that comprises vanillin and p-toluenesulfonic acid, with the additional inert diluent, see [0032], [0049], and [0043] – [0045]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to vary each of the concentrations of the reagent constituents as outlined by Lucas et al. in order to extend the dynamic range of cannabinoid concentrations detected within a solution to provide a wider range of assay results. The results would have been predictable, and since Lucas et al. teaches that the test strip can be entirely coated with a visualization reagent, quickly exposed to an acid, and then dried to yield a quantitative assay result, one of ordinary skill in the art would have pursued the known potential solutions with a reasonable expectation of success.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable Callahan (US Patent 9,759,733, cited on 4/21/2022 IDS), in view of Lucas et al. (US20160018424) and De Wolff (US 2008/0193387) as applied to claim 11 above, and further in view of Amisar (US PG Pub 2011/0117664, cited on 4/21/2022 IDS).
Regarding claim 12, modified Callahan teaches the portable detection kit of claim 11, but does not teach that the non-absorbent container is a syringe, a spray can, a pump spray bottle, a breakable ampoule, a blister pack, or a dropper bottle.
However, in the analogous art of reagents for detecting cannabis, Amisar teaches a device where the non-absorbent container is a dropper bottle (the reagents are dissolved and dispersed using a liquid dropper bottler, see [0043], [0149], and [0151], where the reagent is dropped where the sample has made contact with the test paper).
The use of liquid dropper bottles, breakable glass or plastic ampoules, blister packs and aerosol spray cans to dispense a reagent solution on a test strip to test for cannabis was known in the art before the effective filing date of the instant application (see Col. 1, Lines 63-66 in Callahan and [0043], [0149], and [0151] in Amisar. Therefore, it would have been obvious to a person possessing ordinary skill in the art before the effective filing date of the instant application to have modified the non-absorbent containers, or sachets, of Callahan to include the liquid dropper bottle of Amisar to arrive at the instant invention for the benefit of delivering the reagent to a target surface to detect a suspect residue (see [0151] – [0154]).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Callahan (US Patent 9,759,733, cited on 4/21/2022 IDS) in view of Lucas et al. (US20160018424) and De Wolff (US 2008/0193387) as applied to claim 5 above, and further in view of Glas (US PG Pub 2007/0077660).
Regarding claim 13, modified Callahan teaches the portable detection kit as in claim 5, but does not teach that the device comprises a heating device configured to produce heat sufficient to heat the residue in the form of a plant residue to a temperature greater than or equal to 100°C for about 10 to about 60 seconds, thereby catalyzing conversion of cannabinoid species within the plant residue to psychoactive THC.
However, in the analogous art of kits for detecting cannabinoids in a sample, Glas teaches a device comprising a heating device (lighter 21 used to heat the sample, where heating a cannabis sample allows the separate cannabinoids to elute, see [0106]) configured to produce heat sufficient to heat the residue in the form of a plant residue to a temperature greater than or equal to 100°C for about 10 to about 60 seconds, thereby catalyzing conversion of cannabinoid species within the plant residue to psychoactive THC (the cannabis sample is heated for 1-3 minutes, where the range overlaps the instant application’s range and is therefore considered prima facie obvious, see In re Bergen, 120 F.2d 329, 332, 49 USPQ 749, 751-52 (CCPA 1941)).
It would have been obvious to a person possessing ordinary skill in the art before the effective filing date of the instant application to have modified the prior art of Callahan to comprise the heating device of Gras for the benefit of heating a cannabis sample to extract the cannabinoid content of the sample (see [0106] in Gras). The modification of the device of Callahan to include the heater of Gras would have facilitated the detection of the specific cannabinoid within the sample provided and further would have been anticipated in the art as the device of Callahan is used to detect cannabis consumable products (See Col. 1, Lines, 15-23).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEA MARTIN whose telephone number is (571)272-5283. The examiner can normally be reached M-F 10AM-5:00PM (EST).
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/A.N.M./Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758