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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on March 6, 2026 has been entered.
Claims 1-9, 11-19, and 21-25 are pending in the application. Claims 1, 11, and 22 have been amended. Claims 11-20 and 23-25 are withdrawn from further consideration as being drawn to a nonelected invention. Claims 1-9, 21 and 22 will currently be examined.
Information Disclosure Statement
Receipt of Information Disclosure Statements filed March 6, 2026 and March 11, 2026.
Status of the Claims
The rejection of claims 1-9, 21, and 22 under 35 U.S.C. 103 as being unpatentable over the Guidance for State Medical Cannabis Testing Programs Publication (2016, Association of Public Health Laboratories, Guidance for State Medical Cannabis Testing Programs) in view of the Daley Publication (2013, BOTEC Analysis Corporation), the 7 Benefits of Damiana Publication (2017, Medicinal Herbals) is withdrawn due to Applicant’s amendment of the claims.
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.
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 1-9, 21 and 22 are rejected under 35 U.S.C. 112, 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(s), at the time the application was filed, had possession of the claimed invention. The new matter introduced, “provide consistent results” in claims 1 and 22 lack written description as originally filed. The specification recites “Uniform distribution of the chemical and/or microbial contaminant in the plant substrate may be useful in the proficiency testing material if, for example, a prepared batch of the proficiency testing material is divided into multiple test samples, uniform distribution of chemical and/or microbial contaminant provides/assures there is a consistent amount of the chemical or microbial contaminant in each of the multiple test sample” (page 8, lines 5-15). There is no explicit or implicit recitation of “provide consistent results”. There is consistent amount, but no support for consistent results.
Claims 2-9 and 21 are dependent from claim 1 and are therefore also rejected.
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.
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 1-9, 21, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over the Guidance for State Medical Cannabis Testing Programs Publication (2016, Association of Public Health Laboratories, Guidance for State Medical Cannabis Testing Programs) in view of the Daley Publication (2013, BOTEC Analysis Corporation) and the Bosnak Publication (2017, Spectroscopy Supplements). The Guidance for State Medical Cannabis Testing Programs cited by Applicant on the IDS dated 12/3/2021. The Bosnak Publication cited by Applicant on the IDS dated 3/11/2026.
Applicant’s Invention
Applicant claims a cannabis proficiency testing material comprising: a plant substrate; and at least one chemical and/or microbial contaminant, wherein the at least one chemical and/or microbial contaminant is uniformly or homogeneously incorporated into the plant substrate so that any particular amount of the material may be analyzed and provide consistent results, and wherein the plant substrate is selected from the group consisting of Nepeta cataria, Althaea cannabina, Althaea officinalis, Scutellaria, Mentha, members of the Cleomaceae family, Hibiscus cannabinus, and Humulus lupulus. Applicant claims the plant substrate is a bud, flower, stem, and/or leaf of a plant that is structurally similar to cannabis.
Determination of the scope of the content of the prior art
(MPEP 2141.01)
Regarding claims 1 and 22, Guidance for State Medical Cannabis Testing Programs teach for certification it is necessary to develop a proficiency testing program that includes information to assure a certain level of accountability (page 33, first bullet).
Guidance for State Medical Cannabis Testing Programs teaches under “Sampling and Analysis”, the potency of cannabis products varies by strain. Also, contaminates may be introduced to the plant materials or cannabis products during growing, manufacturing and storage processes (page 26, Sampling and Analysis, paragraph 1).
Guidance for State Medical Cannabis Testing Programs teaches a random sample. Each sample is tested for potency and the composite of the five samples are tested for potency, heavy metals, pesticides and mycotoxin (page 27, Sample Collection, paragraphs 1 and 2).
Regarding claims 1, 6, and 22, Guidance for State Medical Cannabis Testing Programs teaches pesticides in a cannabis plant material can be extracted and analyzed. It is applicable that a wide range of organic compounds that are partitioned in fruits, vegetables and vegetation sample to acetonitrile or other suitable solvents (page 28, Sample Analysis, Sample Preparation, paragraph 1).
Guidance for State Medical Cannabis Testing Programs teaches in sample collections the homogeneity of liquid products is usually better than solid products. For liquid products, the product should be well-mixed by stirring before sample collection. Given the concern for homogeneity of solid cannabis products, a quartering method is recommended. Briefly, the procedure includes the following steps: 1. Place the well-mixed ground products into a square shape; 2. Divide the material into four equal parts; 3. Take two parts from the opposite corners, mix them and collect samples needed; and 4. Repeat steps until the designated number of samples are collected (page 27, Sample Collection, paragraphs 4 and 5).
Guidance for State Medical Cannabis Testing Programs teaches preparation of calibration standards in the same matrix as the sample extract is recommended when testing the plant material (page 30, lines 1-2).
Regarding claims 2 and 3, Guidance for State Medical Cannabis Testing Programs teaches heavy metal contaminates such as lead, cadmium mercury, and arsenic (page 26, Metals, paragraphs 1 and 2).
Regarding claims 4 and 5, Guidance for State Medical Cannabis Testing Programs chemical contaminants include abamectin, acephate, acequinocyl…boscalid, DDVP (dichlorvos)…tebuconazole, thiacloprid, thiamethoxam and trifloxystrobin (pages 16-17, Table 1).
Regarding claim 6, Guidance for State Medical Cannabis Testing Programs teaches various solvents are used during the manufacturing of cannabis extracts, including acetonitrile, chloroform, hexane, methanol, tetrahydrofuran, and toluene (pages 18 and 19, Table 2).
Regarding claim 8, Guidance for State Medical Cannabis Testing Programs teaches microbiologicals include mold, bacteria, and aflatoxins (page 22, Microbiologicals, paragraphs 1-5).
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02)
The Guidance for State Medical Cannabis Testing Programs Publication does not specifically disclose the plant substrate is Nepeta cataria, Althaea cannabina, Althaea officinalis, Scutellaria, Mentha, members of the Cleomaceae family, Hibiscus cannabinus, and Humulus lupulus or the plant substrate is a bud, flower, stem, and/or leaf of a plant that is structurally similar to cannabis. It is for this reason the Daley Publication and the Bosnak Publication are added as secondary references.
The Daley Publication teaches in lieu of inputs for Cannabis, this paper will at times analyze regulations and present residue tolerances for comparable crops, such as leafy vegetables, teas, and spice. The Daley Publication teaches that on one hand, any food product is comparable to Cannabis: both are intended for oral consumption, with or without cooking, so analogies for residue tolerances would seem to be straightforward (page 1, Introduction, paragraph 3).
The Daley Publication teaches all analytical methods for organic pesticides start with a representative sample, one that is randomly selected on the basis of the sample type, subdivided, and well mixed.
Regarding claim 9, samples could include expanded leaves in the field, flowers nearing maturity, crop during curing or at any stage of transportation or storage (Page 17, Sample Preparation Methods, paragraph 1). Residual pesticide compounds must be extracted and isolated from the bulk sample matrix and interfering materials (page 17, Sample Methods, paragraph 2). During extraction, acetonitrile (ACN) is added to homogenized, ground sample in a disposable centrifuge tube (to avoid losses of volatile pesticides, grinding is often performed in the extraction tube with added dry ice) (page 18, Sample Methods, paragraph 5).
The Bosnak Publication teaches the study focuses on an inductively coupled plasma-mass spectrometry (ICP-MS) sample preparation procedure and analytical methodology optimized for both toxic nutritional elements in dried hops, a surrogate for the cannabis family of flowering plants. It shows that the wide dynamic range of the technique allows it to be used for the simultaneous determination of parts-per-billion levels of heavy metals including Pb, As, Cd, and Hg, together with high parts-per-million of nutritional elements, such as P, Ca, K, and Mg (pages 1-2, Abstract). The Bosnak Publication teaches cannabis growers with laboratory capabilities, who are authorized to analyze cannabinoids, can easily gain access to samples for testing purposes. The Bosnak Publication teaches that fortunately, cannabis and humulus (hops used to make beer) belong to the same small family of flowering plants called cannabaceae. For that reason, hops are a generally accepted surrogate for cannabis because of its similar chemical and physical properties (page 2, paragraph 3). The Bosnak Publication teaches hops were purchased from a commercial store and chopped into small pieces, both to homogenize the sample and expose more surface area for increased digestion efficiency (page 3, Sample Preparation). The Bosnak Publication teaches that the work demonstrated the ability of ICP-MS, combined with microwave sample digestion to effectively analyze hops samples (as a surrogate for cannabis) for both nutritional elements (page 8, Conclusions).
Finding a prima facie obviousness
Rationale and Motivation (MPEP 2142-2143)
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to combine the teachings of the Guidance for State Medical Cannabis Testing Programs, the Daley Publication, and the Bosnak Publication and use a plant substrate, Humulus lupulus. Guidance for State Medical Cannabis Testing Programs teaches for certification it is necessary to develop a proficiency testing program that includes information to assure a certain level of accountability. Guidance for State Medical Cannabis Testing Programs teaches pesticides and heavy metals in a cannabis plant material can be extracted and analyzed. It is applicable that a wide range of organic compounds that are partitioned in fruits, vegetables and vegetation sample to acetonitrile or other suitable solvents. One of ordinary skill in the art would have been motivated to use a different plant substrate, particularly one that is comparable to Cannabis because the Daley Publication teaches in lieu of inputs for Cannabis, at times it would be beneficial to analyze regulations and present residue tolerances for comparable crops. It would have been obvious to one of ordinary skill in the art to try Humulus lupulus as a plant structure for a proficiency test for cannabis because the Bosnak Publication teaches that cannabis and humulus (hops used to make beer) belong to the same small family of flowering plants called cannabaceae. For that reason, hops are a generally accepted surrogate for cannabis because of its similar chemical and physical properties. Therefore, it would have been obvious to one of ordinary skill in the art to use humulus with similar effects as cannabis to test for proficiency, with a reasonable expectation of success.
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to combine the teachings of Guidance for State Medical Cannabis Testing Programs, the Daley Publication, and the Bosnak Publication and use a bud, flower, stem and/or leaf of a plant that is structurally similar to cannabis as the plant substrate. Guidance for State Medical Cannabis Testing Programs teaches for certification it is necessary to develop a proficiency testing program that includes information to assure a certain level of accountability. Guidance for State Medical Cannabis Testing Programs teaches pesticides in a cannabis plant material can be extracted and analyzed. It is applicable that a wide range of organic compounds that are partitioned in fruits, vegetables and vegetation sample to acetonitrile or other suitable solvents. It would have been obvious to one of ordinary skill in the art to use teachings of the Daley Publication to determine the cannabis vegetation sample to test. The Daley Publication teaches all analytical methods for organic pesticides start with a representative sample, one that is randomly selected on the basis of the sample type, subdivided, and well mixed. Samples could include expanded leaves in the field, flowers nearing maturity, crop during curing or at any stage of transportation or storage. The Daley Publication further teaches during extraction, acetonitrile (ACN) is added to homogenized, ground sample in a disposable centrifuge tube. It would have been obvious to one of ordinary skill in the art the test methods and samples of the prior art references are similar. As such, one of ordinary skill in the art would have found it obvious to use leaves and flowers as the plant substrate or sample, with a reasonable expectation of success, as a person with ordinary skill has good reason to pursue known options within his or technical grasp. Note: MPEP 2141 [R-6] KSR International CO. v. Teleflex lnc. 82 USPQ 2d 1385 (Supreme Court 2007).
Regarding the limitation of the plant that is structurally similar to cannabis, the Daley Publication teaches in lieu of inputs for Cannabis, this paper will at times analyze regulations and present residue tolerances for comparable crops. The Bosnak Publication teaches that cannabis and humulus (hops used to make beer) belong to the same small family of flowering plants called cannabaceae. As such, based on these teachings, it would have been obvious to one of ordinary skill in the art to use such plants that are structurally similar to cannabis, without evidence to the contrary.
Regarding claim 21, the claim is directed to a “kit” that comprises cannabis proficiency testing material of claim 1, Guidance for State Medical Cannabis Testing Programs teaches pesticides in a cannabis plant material can be extracted and analyzed. It is applicable that a wide range of organic compounds that are partitioned in fruits, vegetables and vegetation sample to acetonitrile or other suitable solvents. Where the only difference between a prior art product and a claimed product is printed matter that is not functionally related to the product, the content of the printed matter will not distinguish the claimed product from the prior art. In re Ngai, 367 F.3d 1336, 1339, 70 USPQ2d 1862, 1864 (Fed. Cir. 2004) (Claim at issue was a kit requiring instructions and a buffer agent. The Federal Circuit held that the claim was anticipated by a prior art reference that taught a kit that included instructions and a buffer agent, even though the content of the instructions differed, explaining "[i]f we were to adopt [applicant’s] position, anyone could continue patenting a product indefinitely provided that they add a new instruction sheet to the product."). See also In re Gulack, 703 F.2d 1381, 1385-86, 217 USPQ 401, 404 (Fed. Cir. 1983)
Therefore, the claimed invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Response to Arguments
Applicant's arguments filed March 6, 2026 have been fully considered but they are not persuasive. Applicant argues that the Guidance for State Medical Cannabis Testing Programs Publication, the Daley Publication, and the 7 Benefits of Damiana Publication fail to teach a proficiency testing material, wherein the at least one chemical and/or microbial contaminant is uniformly or homogenously incorporated into the plant substrate, so that any particular amount of the material may be analyzed and provide consistent results. In response to Applicant’s argument, a new rejection of record has been submitted. In the Sample Collection section of the Guidance for State Medical Cannabis Testing Programs it is taught in sample collections the homogeneity of liquid products is usually better than solid products. It teaches for liquid products; the product should be well-mixed by stirring before sample collection. Given the concern for homogeneity of solid cannabis products, a quartering method is recommended. Briefly, the procedure includes the following steps: 1. Place the well-mixed ground products into a square shape; 2. Divide the material into four equal parts; 3. Take two parts from the opposite corners, mix them and collect samples needed; and 4. Repeat steps until the designated number of samples are collected. Based on this teaching it would have been obvious to one of ordinary skill in the art that the homogeneity of products is important. The Daley Publication teaches in lieu of inputs for Cannabis, this paper will at times analyze regulations and present residue tolerances for comparable crops. The Bosnak Publication teaches that cannabis and humulus (hops used to make beer) belong to the same small family of flowering plants called cannabaceae. As such, based on these teachings, it would have been obvious to one of ordinary skill in the art to use plants that are structurally similar to cannabis, without evidence to the contrary. The claims remain rejected.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Andriae M Holt whose telephone number is (571)272-9328. The examiner can normally be reached Monday-Friday, 8:00 am-4:30 pm EST.
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/ANDRIAE M HOLT/Examiner, Art Unit 1614
/ALI SOROUSH/Supervisory Patent Examiner, Art Unit 1614
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