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 .
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 1-12 and 18-24 are rejected under 35 U.S.C. 103 as being unpatentable over Caroll (US 4,104,027) in view of Salter et al. (US 2009/0298051) and in further view of Lucas et al. (US 2016/0018424).
Regarding claim 1, Caroll teaches a method for qualitative and/or quantitative detection of one or more substances contained in a hemp plant, comprising: providing a kit, the kit including:
an ampoule (col. 6, lines 15-25), the ampoule being transparent (glass);
a material including at least part of a hemp plant (sample comprises THC; hemp; hashish or hash oil);
a color indicator (Duquenois which comprises vanillin and acetaldehyde) configured to react by contacting the material and change the color of the color indicator (Caroll discloses Duquenois which reacts with the hemp plant to change the color of the color indicator; col. 10, lines 2-28);
detecting a change in the color of the color indicator to determine a prensence of a hemp plant (see claim 1).
Caroll does not teach transporting the ampoule to a third party; heating the ampoule; mixing the material and the color indicator together by the third party; and detecting a change in the color of the color indicator by the third party.
Salter teaches a testing kit for testing for analytes in a sample that is in the analogues art of sample collection then colorimetric detection. Salter testing kit comprises a transparent (para. 40) divisible ampoule having a first part and a second part that are divided by a divider (fig. 1-7, ref. 12). The first part (swab container 7) having a material on a swab and a second part (4) having a color indicator for reacting with the material on the swab when the swab comes into contact with the indictor in the second part as seen in fig. 9-10; para 59-62). The first part is separated from the second part by divider 12. The first part and second part are configured to connect to each other as seen in fig. 1-7. Salter provides a divisible ampoule in order to separate the reactants and keep them in a storable state that are ready to used when a sample is taken and results are needed (para 45). Therefore it would have been obvious to one having an ordinary skill in the art to modify Caroll to employ the separated ampoule having each component in each part in order to prolong the storage of the reactants until needed for testing as taught by Salter.
The modified Caroll does not teach transporting the ampoule to a third party; heating the ampoule; mixing the material and the color indicator together by the third party; and detecting a change in the color of the color indicator by the third party.
Lucas et al. teaches a method for cannabinoid quantification which comprises providing a comprising: providing a kit, the kit including:
a sealed airtight container or package that is vacuum sealed (para 39);
a material including at least part of a hemp plant (para 39);
a color indicator (para 32-35) configured to react by contacting the material and change the color of the color indicator;
transporting the package to a third party (the sealed container is transported or moved. The broadest reasonable interpretation is the ampoule is transported a foot within the field. The limitation “transporting” is very broad and does not define a specific distance);
heating the package (para 39, heating the reaction to activated the visualization reagent);
mixing the material and the color indicator together by the third party (mixing the sample and the reagent to produce a colorimetric reaction; para 39); and
detecting a change in the color of the color indicator by the third party (para 39, detecting a color change which represents the concentration of one or more cannabinoids in the solution).
It would have been obvious to one having an ordinary skill in the art at the time of the invention to modify the modified Caroll to employ heating and transporting in order to activate reagents which are well known in the art as taught by Lucas. The reagents employed in Lucas are the same as the instant specification and claim 20.
Regarding claim 2, the method of claim 1, wherein the providing comprises arranging the material and the color indicator separately and unmixed in the ampoule. The modified Caroll employs the teaching of Salter to separate the material and the color indicator separately by a divider until the time for mixing occurs.
Regarding claim 3, the method of claim 1, the ampoule being divisible and having a plurality of parts, wherein the providing comprises separately arranging the material in one part of the ampoule and the color indicator in the other part of the ampoule. The modified Caroll employs the teaching of Salter to separate the material and the color indicator separately by a divider until the time for mixing occurs.
Regarding claim 4, the method of claim 3, wherein the color indicator is a color-forming substance and a reagent, wherein the providing comprises separately arranging the material in a first part of the ampoule, the color-forming substance in a second part of the ampoule and the reagent in a third part of the ampoule. The modified Caroll employs the teaching of Salter to separate the material and the color indicator separately by a divider until the time for mixing occurs.
Regarding claim 5, the method of claim 1, wherein the providing comprises sealing the ampoule containing the material and the color indicator. The modified Caroll employs the teaching of Salter to separate the material and the color indicator separately by a divider until the time for mixing occurs. The parts are employed into an ampoule that has separate compartments.
Regarding claim 6, the method of claim 5, wherein the sealing comprises evacuating the ampoule containing the material and the color indicator. The modified Caroll with the teaching of Lucas above provides vacuum sealing the ampoule to preserve the contents within the ampoule until mixing occurs.
Regarding claim 7, the method of claim 1, wherein the heating comprises inductive heating. Lucas employs heating of the reaction mixture with an outside source of heat (para 39).
Regarding claim 8, the method of claim 1, wherein the detecting is performed using a color comparison scale, an optical sensor, a chemical sensor, or two or more thereof (Carroll and Lucan employ color scales to compare the reaction color to a known color which indicates the concentration of the sample).
Regarding claim 9, the method of claim 8, wherein the detecting is performed through the transparent ampoule (col. 6, lines 15-36).
Regarding claim 10, the method of claim 1, further comprising, after step (e), matching information obtained by the detection in step (e) with data stored in a database (a color comparison is performed from a database of color strips which indicate the concentration of the substance in the sample).
Regarding claim 11, the method of claim 1, further comprising after step (e), creating a database by storage of detected color shades of the material (Carroll teaches a color comparison standard is created from known substances prior to testing of an unknown sample).
Regarding claim 12, the method of claim 11, wherein the color shades are stored in the database together with a location or origin of the material (color comparison include various shades of the same color which indicate various concentrations of a sample substance).
Regarding claim 18, the method of claim 1, wherein the material comprises a cannabis flower, marijuana, hashish, hashish oil, at least one cannabinoid, or a mixture thereof (Carroll teaches THC, hashish, hash oil).
Regarding claim 19, the method of claim 1, wherein the material is provided in fresh or dried form (samples are finely ground powders).
Regarding claim 20, the method of claim 1, wherein the color indicator comprises a color-forming substance preferably selected from the group consisting of true black, true blue salt, dibromoquinone chlorimide, dichloroquinone chlorimide, vanillin (Reagent formulations, Carroll), salicylaldehyde, formaldehyde, acetaldehyde, p-dimethylaminobenzaldehyde, diethylaminobenzaldehyde, ferric chloride, aminophenol, potassium ferricyanide, and a mixture of two or more thereof.
Regarding claim 21, the method of claim 1, wherein the color indicator comprises at least one solvent preferably selected from the group consisting of water and monohydric or polyhydric alcohols (reagent formulations, Carroll).
Regarding claim 22, the method of claim 20, wherein the color indicator further comprises a reagent that assists in reacting the material with the color-forming substance, wherein the reagent is preferably a basic compound, more preferably selected from the group consisting of alkali hydroxide, alkali carbonate, ammonium or alkali salts of an organic acid, and a mixture of two or more thereof (Reagent formations ammonium).
Regarding claim 23. The method according to claim 20, wherein the color indicator further comprises a carrier material, preferably an absorbent neutral carrier material (test strip, Lucas).
Regarding claim 24, the method of claim 1, wherein the providing comprises disposing the color indicator on at least a portion of an inner wall of the ampoule (the color indicator is added to the ampoule and would inherently contact a portion of the inner wall it rest upon).
Claims 13-16 are rejected under 35 U.S.C. 103 as being unpatentable over Caroll (US 4,104,027) in view of Salter et al. (US 2009/0298051) in view of Lucas et al. (US 2016/0018424) and in further view of Nelson et al. (US 2008/0306439).
Regarding claims 13-15, the modified Carroll does not teach a bar code applied to the ampoule that provided information regarding the contents.
Nelson teaches a device for mixing and applying a fluid composition that comprises a packaging that employs identifier. The identifier may take any form including a label (e.g., barcode, magnetic strip, laser-readable recognition pattern) applied on the applicator device or its packaging, a hardware or electronic identifier (e.g., microchip, radio frequency identification device) embedded in the applicator device or its packaging, or other suitable identifier readily readable or recognizable by a system usable at the point-of-care, such as a hand-held or stand-alone reader or recognition device, a computer terminal, a barcode scanner, or other suitable input device. Preferably, the identifier is in the form of a barcode label applied to the outer periphery of the applicator device or its packaging. The identifier can include information such as, but not limited to, any one or more of the composition, amount, lot number, and expiration date of the dry constituent loaded in the applicator device; instructions for mixing dry constituent with fluid constituent in forming a fluid composition; operating parameters of the applicator device; lot number of the applicator device; or a combination thereof. The system may upload the information communicated by the identifier so that an individual can track distribution of the applicator device, ensure that the applicator device selected for use contains the correct dry constituent for the intended use, track and record use of an applicator device to a specific individual (e.g., patient) receiving the fluid composition or medical device coated with the fluid composition, track and record removal of the applicator device from the vicinity of the patient (and may further include proper disposal of the applicator device), and a combination thereof.
Therefore it would have been obvious to one having an ordinary skill in the art at the time of the invention to modify Carroll to employ a bar code applied to the ampoule in order to provided information pertaining to the composition of the contents therein, lot number, date of the dry constituent loaded into the device, mixing instructions and the such as is well known as taught by Nelson.
Regarding claim 16, the method of claim 13, further comprising, after applying the detected results, reading out the applied data in a docking station. The modified Carroll with the teaching of Nelson provide a docking station that reads the bar code and uploads the information to a system that tracks the information of the contents of the container. It would have been obvious to one having an ordinary skill in the art at the time of the invention to modify Carroll to provide a device that reads and stores the information of the barcode in order to transfer and track information regarding the contents of the container as is taught by Nelson.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Caroll (US 4,104,027) in view of Salter et al. (US 2009/0298051) in view of Lucas et al. (US 2016/0018424) and in further view of Butlin et al. (US 2011/0028863).
Regarding claim 17, the modified Carroll does not teach the ampoule/container is made of borosilicate glass.
Butlin teaches a sample container which is made of borosilicate glass seen in fig. 1. Borosilicate glass is employed due to effectively neutral adsorption and leaching profile relative to the sample and reagent (para 54) which is routinely employed in chemical testing devices to hold reagents or samples. Therefore it would have been obvious to one having an ordinary skill in the art to modify the modified Carroll to make the device out of borosilicate glass as the material has a neutral adsorption and leaching profile that will not interact with the sample and reagents. This is a well known material used for the above purpose in the analogous art of sample collection and testing.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMUEL P SIEFKE whose telephone number is (571)272-1262. The examiner can normally be reached Monday-Friday 8-5.
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/SAMUEL P SIEFKE/Primary Examiner, Art Unit 1758
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