DETAILED ACTION
In application filed on 12/08/2023, Claims 1, 6 and 9-18 are pending. The claim set submitted on 12/15/2025 is considered because this is the most recent claim set with some preliminary amendments. Claims 1, 6 and 9-17 are considered in the current office 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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on03/24/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Election/Restrictions
Applicant’s election of Group I in the reply filed on 07/06/2026 acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claim 18 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Groups, there being no allowable generic or linking claim.
Group I, Claims 1, 6 and 9-17 are considered on the merits below.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 6 and 9-18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims have been analyzed for eligibility in accordance with their broadest reasonable interpretation. All claims are directed to statutory categories, i.e., a method (Claims 1, 6 and 9-18) (Step 1: YES).
Analysis:
Claim 1: Ineligible.
Step 1:
The claim recites a series of steps or acts, including “a detection kit for identifying the presence of a drug”. Thus, the claim is directed to device (Apparatus or Product), which is one of the statutory categories of invention (Step 1: YES).
Step 2A Prong 1:
Claim 1 recites “the chemical reaction produces a visible color change that is indicative of the presence of the drug within the sample residue” (mental step)”.
Therefore, the claim is directed towards an abstract idea, and more specifically to the abstract idea group of a mental process since claim 1 relates to using a mental process to evaluate for the “indication step”.
Step 2A, Prong 2:
This judicial exception is not integrated into a practical application.
Once the indication is done, no further action take place, much less a particular practical application.
Also the steps of:
“a substrate comprising a dry colorimetric reagent comprising bismuth nitrate,potassium iodide, and an acid selected from the group consisting of ascorbic acid, toluenesolfonic acid, benzoic acid, citric acid, and any combination thereof: and
a delivery device containing a solvent or solvent mixture including the solvent;
wherein the delivery device is configured to contact a portion of the solvent or solvent mixture to a target residue comprising at least one of an amphetamine, cocaine, cathinone, heroin, lysergic acid diethylamide, nicotine, a synthetic cannabinoid, and/or a fentanyl analogue to form a sample residue;
wherein, when at least a portion of the sample residue is brought into contact with the dry colorimetric reagent, the dry colorimetric reagent mixture undergoes a chemical reaction when the sample residue contains at least one of an amphetamine, cocaine, cathinone, heroin, lysergic acid diethylamide, nicotine a synthetic cannabinoids, and a fentanyl analogue” are recited at a high level of generality that it amounts to mere data gathering (insignificant extra-solution activity). See MPEP 2106.05(g).
Also, while a substrate; a delivery device and other structural elements are recited, there structural elements appear to be a particular machines. See MPEP 2106.05(b).
(Step 2A, Prong 2: NO).
Step 2B:
Furthermore, the courts have found that limitations adding insignificant extrasolution activity to the judicial exception, such as mere data gathering in conjunction with a law of nature or abstract idea, are limitations found not to be enough to qualify as ‘significantly more’ when recited in a claim with a judicial exception (see the 2014 Interim Guidance on Patent Subject Matter Eligibility of the Federal Register dated December 16, 2014; and MPEP 2106.05(I)(A)). Note that mere data gathering is not significantly more than the abstract idea. See MPEP 2106.05(g).
Here, there are no additional elements which are significantly more than the abstract idea and the additional elements appear to be well-understood, routine, and conventional (WURC) in the field of clinical diagnostics, as evidenced by Callahan et al. (US10330603B1) in view of Callahan et al. (US9759733B1, hereinafter ‘Callahan’733’). (Step 2B: NO).
Therefore, Claim 1 is ineligible.
Moreover, Claims 6 and 9-17 are rejected by virtue of their dependency on Claim 1.
In addition, the limitations of Claims 1, 6 and 9-17 do not solve the 101 issues of Claim 1.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 recites “the presence…” in line 1 of the Claim. It appears that this limitation should be recited as “a presence…”.
Appropriate correction is required.
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.
Claims 1, 6 and 9-17 are rejected under 35 U.S.C. 103 as being unpatentable over Callahan et al. (US10330603B1) in view of Callahan et al. (US9759733B1, hereinafter ‘Callahan’733’).
Regarding Claim 1, Callahan teaches a detection kit for identifying the presence of a drug (See Abstract… A highly portable, paper and swab-based detection kit is provided for identifying chemical and biological agents; It is known that drugs are chemical /biological agents), the kit comprising:
a substrate (referred to as a solid support article [Col. 7, line 13; Fig. 1, ref. 1]; which is included in the kit [ See Fig. 1, ref. 10 ]) comprising a dry colorimetric reagent (referred to as first dry chemical powder colorimetric reagent (CR) [Col. 7, lines 10-11]) comprising bismuth nitrate, potassium iodide (See Col.8, lines 8-9…wherein the first CR is selected from the group consisting of:…, potassium iodide, bismuth nitrate); and
a delivery device (‘pre-wetted swab’) containing a solvent or solvent mixture (See Col.2, lines 15-17… non-hazardous co-solvents) including the solvent (See Col.2, lines 15-17… pre-wetted swab with non-hazardous co-solvents to facilitate enhanced suspect residue collection.);
wherein the delivery device (‘pre-wetted swab’) is configured to contact deliver a portion of the solvent or solvent mixture (See Col.2, lines 15-17… non-hazardous co-solvents) to a target residue (‘suspect residue’) (See Col.2, lines 15-17… pre-wetted swab with non-hazardous co-solvents to facilitate enhanced suspect residue collection.);
wherein, when at least a portion of the sample residue is brought into contact with the dry colorimetric reagent (‘coated solid support article’ where the coat is the ‘dry colorimetric reagent’) (See Col. 6, lines 31-34…The swab 30 is rubbed into the suspect residue, liquid, gel, solid and/or across suitable surfaces for several seconds, to facilitate the collection of a representative sample of the suspect residue; See Col.7, lines 14-19… swab device pre-wetted with a solvent to facilitate the collection and transfer of a suspected chemical or biological agent residue to the coated solid support article and upon contacting the residue with the coated solid support article and mixing all components together on the coated solid support article), the dry colorimetric reagent undergoes a chemical reaction (See Col. 7, lines 19-22… a known visual colorimetric indication is produced identifying a class of an unknown target chemical or biological agent present in the suspect residue).
Callahan does not teach:
an acid selected from the group consisting of ascorbic acid, toluenesolfonic acid, benzoic acid, citric acid, and any combination thereof: and
target residue comprising at least one of an amphetamine, cocaine, cathinone, heroin, lysergic acid diethylamide, nicotine, a synthetic cannabinoid, and/or a fentanyl analogue to form a sample residue;
when the sample residue contains at least one of an amphetamine, cocaine, cathinone, heroin, lysergic acid diethylamide, nicotine a synthetic cannabinoids, and a fentanyl analogue; and
wherein the chemical reaction produces a visible color change that is indicative of the presence of the drug within the sample residue.
In the analogous art of a highly portable, paper and swab-based detection kit is
provided for identifying Amphetamine, Cannabis, Cocaine, Heroin, selected synthetic Cannabinoid, and amphetamine based Cathinone type stimulants, and cannabis consumable products, Callahan’733 teaches:
an acid selected from the group consisting of ascorbic acid, toluenesolfonic acid, benzoic acid, citric acid, and any combination thereof (See Col. 16, lines 25-28…the acids are selected from the group consisting of sodium hydrogen sulphate, citric acid, tartaric acid, and ascorbic acid);
target residue comprising at least one of an amphetamine, cocaine, cathinone, heroin, lysergic acid diethylamide, nicotine, a synthetic cannabinoid, and/or a fentanyl analogue to form a sample residue (See Col. 8, lines 6-9… In order to maximize solubility of both the suspect residue narcotic (i.e. Amphetamine, Cannabis, Cocaine, Heroin, selected synthetic Cannabinoid and amphetamine based Cathinone type stimulants, and cannabis consumable, thereby teaching target residue to form a sample residue);
when the sample residue contains at least one of an amphetamine, cocaine, cathinone, heroin, lysergic acid diethylamide, nicotine a synthetic cannabinoids, and a fentanyl analogue (See Col. 8, lines 6-9… In order to maximize solubility of both the suspect residue narcotic (i.e. Amphetamine, Cannabis, Cocaine, Heroin, selected synthetic Cannabinoid and amphetamine based Cathinone type stimulants, and cannabis consumable, thereby teaching target residue to form a sample residue); and
wherein the chemical reaction produces a visible color change (‘a chemical reaction is facilitated to produce a presumptive colorimetric indication’) that is indicative of the presence of the drug within the sample residue (See Col. 14, lines 27-31…The portable detection kit as in claim 1, wherein the chemical reagent comprises a dry micronized powder comprising an organic or inorganic salt of polyvalent ions or an organic dye salt, which undergo characteristic color change when combined with the target narcotic; See Col. 18, lines 43-50…rubbing the swab device through the dry reagent powder on the solid support article to mix together the suspect residue, the dry reagent powder, and the swab wetting solvent; whereby a chemical reaction is facilitated to produce a presumptive colorimetric indication of the presence of a target narcotic if a target narcotic is present).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the detection kit to incorporate “an acid selected from the group consisting of ascorbic acid, toluenesolfonic acid, benzoic acid, citric acid, and any combination thereof: and target residue comprising at least one of an amphetamine, cocaine, cathinone, heroin, lysergic acid diethylamide, nicotine, a synthetic cannabinoid, and/or a fentanyl analogue to form a sample residue; when the sample residue contains at least one of an amphetamine, cocaine, cathinone, heroin, lysergic acid diethylamide, nicotine a synthetic cannabinoids, and a fentanyl analogue; and wherein the chemical reaction produces a visible color change that is indicative of the presence of the drug within the sample residue”, as taught by Callahan’733 for the benefit of providing a presumptive spot test kit which will facilitate identification of Amphetamine, Carmabis, Cocaine, Heroin, selected synthetic Carmabinoid and amphetamine based Cathinone type stimulants and carmabis consumable products within suspect residues, be they liquid or solid (Callahan’733, Col. 6, lines 51-66) which allows for the provision of a portable test kit capable of identifying the presence of Amphetamine, Cannabis, Cocaine, Heroin, selected synthetic Cannabinoid and amphetamine based Cathinone type stimulants, and cannabis consumable products, a process to inexpensively mass produce the portable test kit and achieve long term commercial shelf life in the range of 2 to 3 years, and a method to use the portable test kit (Callahan’733, Col. 1, lines 15-22).
Regarding Claim 6, the detection kit of claim 1 is obvious over Callahan in view of Callahan’733’.
Callahan teaches that the dry colorimetric reagent (referred to as first dry chemical powder colorimetric reagent (CR) [Col. 7, lines 10-11]) is configured to undergo chemical reaction (See Col. 6, lines 37-38…the colorimetric reagent test zones 2, 4 on the paper strip 1 for several seconds, facilitating a rapid yes/no positive/negative colorimetric indication on the test strip 1 or swab 30 for the presence of target chemical or biological agents) with the target residue (See Col.2, lines 15-17…suspect residue collection) in the form of liquids, gels or solid powders (See Col. 6, line 32…into the suspect residue, liquid, gel, solid) that are pure (See Col. 6, line 32…into the suspect residue, liquid, gel, solid…Examiner submits under BRI that the suspect residue, liquid, gel, solid is pure). The limitation “or admixed with cutting agents” interpreted as optional.
Regarding Claim 9, the detection kit of claim 1 is obvious over Callahan in view of Callahan’733’.
Callahan teaches that wherein the substrate (referred to as a solid support article [Col. 7, line 13; Fig. 1, ref. 1]; which is included in the kit [ See Fig. 1, ref. 10 ]) with the dry colorimetric reagent (referred to as first dry chemical powder colorimetric reagent (CR) [Col. 7, lines 10-11]) forms a reaction zone (referred to as test zones [Col. 2, line 15]) , wherein the chemical reaction (‘color change reagents’; See Col. 6, lines 37-38…the colorimetric reagent test zones 2, 4 on the paper strip 1 for several seconds, facilitating a rapid yes/no positive/negative colorimetric indication thereby “chemical reaction”) occurs at the reaction zone (Col. 2, lines 14-15…with color change reagents applied to the surface as one or more test zones).
Regarding Claim 9, the detection kit of claim 1 is obvious over Callahan in view of Callahan’733’.
Callahan teaches that the substrate (referred to as a solid support article [Col. 7, line 13; Fig. 1, ref. 1]; which is included in the kit [ See Fig. 1, ref. 10 ]) is formed of at least one of fibers or polymers (Col. 8, lines 57-59…solid support article is selected from the group consisting of glass, metal, paper, textiles, organic membranes, inorganic membranes, natural fibers, and synthetic fibers).
Regarding Claim 11, the detection kit of claim 1 is obvious over Callahan in view of Callahan’733’.
Callahan teaches that the substrate (referred to as a solid support article [Col. 7, line 13; Fig. 1, ref. 1]; which is included in the kit [ See Fig. 1, ref. 10]) is a paper card, a paper sheet, a synthetic paper, or chromatography paper. (Col. 8, lines 57-59…solid support article is selected from the group consisting of glass, metal, paper, textiles, organic membranes, inorganic membranes, natural fibers, and synthetic fibers; See Col.3 lines 40-41…the solid support substrate 1 is paper, such as 100-400 gsm white, acid free, card sheet).
Regarding Claim 12, the detection kit of claim 1 is obvious over Callahan in view of Callahan’733’.
Callahan teaches that wherein the delivery device (See Col. 2, line 16…‘pre-wetted swab’) includes an absorbent material (See Col. 3, lines 50-51…the sample swab 30 is a pre-wetted, co-solvent, cotton swab 30; See Col. 7 lines 14-16…a swab device pre-wetted with a solvent to facilitate the collection and transfer of a suspected chemical or 15 biological agent residue, thereby teaching “an absorbent material”).
Regarding Claim 13, the detection kit of claim 1 is obvious over Callahan in view of Callahan’733’.
Callahan teaches that wherein the delivery device (See Col. 2, line 16…‘pre-wetted swab’) is a cotton swab (See Col. 3, lines 50-51…the sample swab 30 is a pre-wetted, co-solvent, cotton swab 30) that absorbs (See Col. 3, lines 17-18…which has been pre-wetted with a non-hazardous solvent, thereby teaching “absorbs” ) the solvent or solvent mixture (See Col.2, lines 15-17… non-hazardous co-solvents).
Regarding Claim 14, the detection kit of claim 1 is obvious over Callahan in view of Callahan’733’.
Callahan teaches that wherein the delivery device (See Col. 2, line 16…‘pre-wetted swab’) is a snap cotton swab (See Col. 3, lines 50 -53…a kit 10, the sample swab 30 is a pre-wetted, co-solvent, cotton swab 30. Numerous swab/ solvent devices can be prepared including, but not limited to, dip impregnation, shaft-handle fill and pop or snap swabs) that selectively stores the solvent or solvent mixture (See Col. 3, line 45-49…a suitable non-hazardous solvent and/or solvent mix provided in combination with a swabbing device. Numerous swab and co-solvent devices can be prepared including, but not limited to, a pre-wetted cotton swab and/or co-solvent shaft filled pop or snap swabs) in a shaft (See Col. 3, lines 47-49…Numerous swab and co-solvent devices can be prepared including, but not limited to, a pre-wetted cotton swab and/or co-solvent shaft filled pop or snap swabs).
Regarding Claim 15, the detection kit of claim 1 is obvious over Callahan in view of Callahan’733’.
Callahan teaches that wherein the substrate (referred to as a solid support article [Col. 7, line 13; Fig. 1, ref. 1]; which is included in the kit [ See Fig. 1, ref. 10 ]) and the delivery device (See Col. 2, line 16…‘pre-wetted swab’; Fig. 2, ref. 30) are each enclosed and separated from each other (See Col.6, lines 1-8…Individual pre-wetted sample swabs 30 and individual printed dry reagent test strips 10 be automatically packaged into individual sachets 40 by vertical and/or horizontal form fill seal machines; See Col. 3, lines 15-16…any solid support 15 structure, to be shaped and packaged.; See Col. 3, lines 15-18…combination with a simple cotton swab, such as a Q-tip® swab, which has been pre-wetted with a non-hazardous solvent and packaged, thereby teaching “each enclosed and separated from each other”) in respective containers (referred to as UV resistant packages 40 [Col. 5, lines 67]).
Regarding Claim 16, the detection kit of claim 1 is obvious over Callahan in view of Callahan’733’.
Callahan teaches further comprising a packet (See Col. 6, lines 1-4…Preferably the package 40 is a tear-open, form, fill, and seal sachet. The sachet 40 may be constructed from commercially available Paper/PET12 um/AL7 um/PESO product, which is an extremely cheap, mass produced material)) that is configured to selectively house (See Col. 6, lines 27-28…The kit (test strip 10 and swab 30, in the sealed package 40) the substrate (referred to as a solid support article [Col. 7, line 13; Fig. 1, ref. 1]; which is included in the kit [ See Fig. 1, ref. 10 ]) and the delivery device (See Col. 2, line 16…‘pre-wetted swab’).
Regarding Claim 17, the detection kit of claim 16 is obvious over Callahan in view of Callahan’733’.
Callahan teaches that wherein the packet (See Col. 6, lines 1-4…Preferably the package 40 is a tear-open, form, fill, and seal sachet. The sachet 40 may be constructed from commercially available Paper/PET12 um/AL7 um/PESO product, which is an extremely cheap, mass produced material)) is hermetically sealed (See Col. 6, lines 5-8…Individual pre-wetted sample swabs 30 and individual printed dry reagent test strips 10 be automatically packaged into individual sachets 40 by vertical and/or horizontal form fill seal machines).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OYELEYE ALEXANDER ALABI whose telephone number is (571)272-1678. The examiner can normally be reached on M-F 7:30am-5:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander can be reached on (571) 272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/OYELEYE ALEXANDER ALABI/ Examiner, Art Unit 1797
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