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 .
Election/Restrictions
Applicant’s election of the invention of Group I, claims 46-60, in the reply filed on 04/21/2026 is 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 Status
The response of 04/21/2026 has been entered. Claims 46-75 are pending in this US patent application. Claims 61-75 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 04/21/2026.
Claims 46-60 are currently under examination and were examined on their merits.
Information Disclosure Statement
The information disclosure statements filed in this application on 04/19/2024 and 10/17/2025 have been received and considered.
Claim Rejections - 35 USC § 112
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 46-60 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 46 and 55 recite a “high temperature melting solvent.” The term “high” is a term of degree that is not defined in the instant disclosure: what temperature constitutes a “high” temperature? As such, one of ordinary skill in the art would be unable to determine the metes and bounds of claims 46 and 55, rendering them indefinite.
Claim 54, as worded, recites that the matrix solution comprises beta-glucuronidase isolated from six different sources. However, given that the instant specification does not disclose performing the reaction using six different beta-glucuronidases in one matrix solution, it appears that the current wording of claim 54 may be a typographical error. As such, one of ordinary skill in the art would be unable to determine the metes and bounds of claim 54, rendering it indefinite.
Because claims 47-60 depend from the indefinite claim 46 and do not provide any further clarification of the indefinite language therein, these claims are also indefinite. Therefore, claims 46-60 are rejected under 35 U.S.C. 112(b).
In the interest of compact prosecution, the Examiner has interpreted the “high temperature melting solvent” of claims 46 and 55 to be any solvent. The Examiner has interpreted claim 54 to recite that the matrix solution comprises beta-glucuronidase isolated from Patella vulgata, Helix aspersa, Helix pomatia, abalone, purified recombinant systems, OR mammalian liver (emphasis on ‘or’ added to highlight the Examiner’s interpretation).
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.
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 46 and 51-54 are rejected under 35 U.S.C. 103 as being unpatentable over Kemp et al., Comparison of species-specific beta-glucuronidase hydrolysis of cannabinoid metabolites in human urine, Federal Aviation Administration, March 2015 (cited on the IDS filed 04/19/2024).
Kemp teaches a device for quantifying THC in urine samples (see entire document, including title and page 3, first column, paragraph 2; cf. claim 46). In the device, the urine samples were placed into 16x100-mm glass culture tubes along with 5000 units of β-glucuronidase enzyme from either Patella vulgata, Helix pomatia, bovine liver, or abalone, a THC analyte internal standard solution, and an aqueous buffer solution ranging from pH 3-7, adjusted with glacial acetic acid (page 2, right column, paragraph 1; cf. claims 46, 51-54). The glucuronidase enzyme solution is stored frozen in centrifuge tubes (page 2, left column, paragraph 4; cf. claim 46 [“…the matrix solution is separated from the standard solution in a receptacle”]).
However, Kemp does not explicitly teach that the matrix solution is separated from the standard solution in said receptacle or plurality of receptacles and that these solutions are not in substantial admixture, as recited in instant claim 46.
While Kemp does not explicitly teach that the matrix solution is separated from the standard solution in said receptacle or plurality of receptacles and that these solutions are not in substantial admixture, the modification of providing wherein the matrix solution is placed with the standard solution in said receptacle or plurality of receptacles, and the matrix solution and the drug standard solution are not in substantial admixture would have been conventional to one of ordinary skill in the art at the time of the invention, provided the previous disclosures of Kemp for the benefit of keeping the enzyme frozen and inactivated in the test tube until the time of testing, combining the enzyme with the analyte solution, and allowing the enzyme and the analyte to come into contact simply by thawing.
Therefore, claims 46 and 51-54 are rendered obvious by Kemp and are rejected under 35 U.S.C. 103.
Claims 46 and 49-60 are rejected under 35 U.S.C. 103 as being unpatentable over Kemp et al., Comparison of species-specific beta-glucuronidase hydrolysis of cannabinoid metabolites in human urine, Federal Aviation Administration, March 2015 (cited on the IDS filed 04/19/2024), in view of Valen et al., Drug Testing and Analysis 9: 808-823 (2017; cited on the IDS filed 10/17/2025).
As discussed above, claims 46 and 51-54 are rendered obvious by Kemp. In addition, Kemp teaches that, following the glucuronidase hydrolysis reaction, the hydrolyzed samples containing internal cannabinoid standards are subjected to liquid-liquid extraction and then analyzed through mass spectrometry (page 2, right column, paragraph 4). However, Kemp does not teach the performance of the assay in an automated fashion or the analysis of the samples for additional drug metabolites.
Valen teaches that biological samples can be screened for the presence of multiple drug metabolites, including cannabinoid metabolites, in an automated manner in 96-well plates with supported liquid extraction of the sample and mass spectrometry analysis (see entire document, including page 810, left column, paragraph 1; cf. claims 57-60). The analysis is improved by adding isotopically labeled internal standards, which may include 6-MAM in concentrations from 0.049-19.8 ng/mL, in the mixtures comprising biological samples and buffer (page 810, left column, paragraph 1; page 815, Table 2; cf. claims 55-56). Liquids of different composition were dispensed in the automated system through the use of air gaps to prevent dripping (page 810, left column, paragraph 2; cf. claims 49-50). Automation of sample preparation prevents human errors, saves time, and saves workers from non-ergonomic repetitive work (page 808, right column, paragraph 1).
While Kemp does not teach the performance of the assay comprising glucuronidase hydrolysis of biological samples and liquid extraction prior to mass spectrometry in an automated fashion or the analysis of the samples for additional drug metabolites other than cannabinoids, it would have been obvious to one of ordinary skill in the art to do so because Valen teaches that such assays may be automated and because such automation would prevent human errors, save time, and save workers from non-ergonomic repetitive work. One of ordinary skill in the art would have a reasonable expectation that performing the assay of Kemp in the automated system of Valen and also testing for the multiple metabolites of Valen would successfully result in the analysis of the samples of Kemp for the presence of the metabolites of multiple drugs of abuse.
Therefore, claims 46 and 49-60 are rendered obvious by Kemp in view of Valen and are rejected under 35 U.S.C. 103.
Claims 46-60 are rejected under 35 U.S.C. 103 as being unpatentable over Kemp et al., Comparison of species-specific beta-glucuronidase hydrolysis of cannabinoid metabolites in human urine, Federal Aviation Administration, March 2015 (cited on the IDS filed 04/19/2024), in view of Valen et al., Drug Testing and Analysis 9: 808-823 (2017; cited on the IDS filed 10/17/2025), and Patel et al., AAPS PharmSciTech 12(1): 372-378 (2011; cited on the IDS filed 10/17/2025).
As discussed above, claims 46 and 49-60 are rendered obvious by Kemp in view of Valen. However, these references do not teach storing the reagents in a lyophilized state.
Patel teaches that freeze-drying is widely used to convert solutions of unstable materials into solid form by removing the solvent, usually water, to improve the long-term storage stability (see entire document, including page 372, left column, paragraph 1). Freeze-drying can be performed on 96-well plates (page 376, left column, paragraph 1, to right column, paragraph 2).
While Kemp and Valen do not teach lyophilizing the 96-well plate following liquid extraction of the samples, it would have been obvious to one of ordinary skill in the art to do so to improve the long-term stability of the samples so that they could be analyzed using mass spectrometry at a later time. Doing so would intrinsically result in the solutions forming “independently separated frozen layers” because each molecule in the the solutions will remain separate and intact, and claim 47 does not in any way limit the size, shape, or properties of the “layers.” Upon freezing, the solutions would also be in a “solid” state and would be “suspended” within the containers as recited in instant claim 48, which does not limit the “suspended” state in any way. One of ordinary skill in the art would have a reasonable expectation that lyophilizing the plate rendered obvious by the combination of Kemp and Valen prior to mass spectrometry analysis would successfully result in the improved storage stability of the processed biological samples.
Therefore, claims 46-60 are rendered obvious by Kemp in view of Valen and Patel and are rejected under 35 U.S.C. 103.
The Supreme Court has acknowledged:
When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one. If a person of ordinary skill can implement a predictable variation…103 likely bars its patentability…if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond that person’s skill. A court must ask whether the improvement is more than the predictable use of prior-art elements according to their established functions……the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results (see KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 U.S. 2007) (emphasis added).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Erin M. Bowers, whose telephone number is (571)272-2897. The examiner can normally be reached Monday-Friday, 7:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila Landau, can be reached at (571)272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Erin M. Bowers/Primary Examiner, Art Unit 1653 07/11/2026
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