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 group 1 comprising claims 1 – 17 in the reply filed on 12/8/2025 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)). Applicant canceled nonelected claims 18 – 24.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
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.
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.
Claim(s) 1, 2, 5, 8, 9, 11, 12, 15 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over DeGregorio et al. (WO 2019/209649 A1; “DeGregorio”) in view of Son et al. (WO 2013/062618 A2; “Son”).
Regarding claim 1, DeGregorio teaches a method for determining recent use of cannabis within the impairment window in a subject (paragraphs 13 and 36), the method comprising:
the collection of one or more exhaled breath samples separated in time by approximately three minutes and one or more whole blood samples separated in time by approximately 20 minutes (paragraph 13),
analyzing them for ∆9-THC, ∆9-THC metabolites, and other cannabinoids (paragraph 32), and then
computing specific breath- and blood-based pharmacokinetic parameters and cannabinoid profiles to determine recent use of cannabis within the impairment window (paragraphs 13, 14 and 32).
DeGregorio does not specifically teach the collection of one or more exhaled breath samples separated in time by approximately three minutes.
DeGregorio does teach that the method can be used in combination with other technologies, such as a breathalyzer device (paragraph 33).
However, Son teaches the use of a breathalyzer device that periodically (e.g., using a separation interval comprising every five or ten minutes) requests a user to provide breath samples until a sufficient number of measurements are obtained to calibrate and provide an accurate test measurement (paragraph 51). The separation interval between each breath sample can be considered a known-result effective variable whose determination would have been within the ambit of a person of ordinary skill in the art due to routine experimentation considering the type of target analyte analyte being detected and breathalyzer device being employed. The use of a known technique to improve similar devices (methods or products) in the same way is likely to be obvious (see MPEP § 2143, C.). Applying a known technique to a known device (method or product) ready for improvement to yield predictable results is likely to be obvious (see MPEP § 2143, D.). Therefore, it would have been obvious to a person of ordinary skill in the art before the filing date of the claimed invention to provide the step of collecting one or more exhaled breath samples separated in time by approximately three minutes.
Regarding claim 2, DeGregorio teaches the method of claim 1, whereby the subject has used cannabis through smoking, vaping, or any other route of inhalation (paragraph 13).
Regarding claim 5, DeGregorio teaches the method of claim 2, whereby the subject is tested for recent cannabis use and impairment by an employer or prospective employer (paragraph 15).
Regarding claim 8, DeGregorio teaches the method of claim 5, whereby the subject is tested for recent cannabis use only by collecting two or more blood samples using a device that automatically collects and stores capillary blood for later laboratory analysis, or by collecting two or more blood samples using any other acceptable means of blood collection (paragraphs 13 and 71).
Regarding claim 9, DeGregorio teaches the method of claim 2, whereby the subject, as a result of suspicion of driving under the influence of cannabis, is tested for recent cannabis use and impairment by law enforcement personnel by collecting two exhaled breath samples and two blood samples (paragraphs 14, 15 and 33).
Regarding claim 11, DeGregorio teaches the method of claim 1, whereby the pharmacologic parameters used for determining recent use of cannabis are specifically adapted for oral administration of cannabis (paragraphs 45, 46 and 49).
Regarding claim 12, DeGregorio teaches the method of claim 5, whereby the samples are analyzed and assessed using recent use parameters specific for oral consumption of cannabis (paragraphs 45, 46 and 49).
Regarding claim 15, DeGregorio teaches the method of claim 8, whereby the samples are analyzed and assessed using recent use parameters specific for oral consumption of cannabis (paragraphs 45, 46 and 49).
Regarding claim 16, DeGregorio teaches the method of claim 9, whereby the samples are analyzed and assessed using recent use parameters specific for oral consumption of cannabis (paragraphs 45, 46 and 49).
Claim(s) 3 and 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over DeGregorio et al. (WO 2019/209649 A1; “DeGregorio”) and Son et al. (WO 2013/062618 A2; “Son”), and further in view of Wing et al. (US 9,291,550 B1; “Wing”).
Regarding claim 3, modified DeGregorio does not specifically teach the method of claim 2, whereby a single blood sample can be used as a confirmatory test to support a finding of recent cannabis use within the impairment window based on two breath samples.
DeGregorio does teach that breathalyzer devices can be unreliable for detecting cannabis use, and their disclosed method can be used in combination with other technologies (paragraph 33). DeGregorio does teach that their disclosed model is not restricted to just a two-point analysis, and three or more samples can be collected and use in the analysis (paragraph 33). Son also teaches that multiple breath samples can be collected using their breathalyzer device (paragraph 51).
Wing teaches a device and method for drug detection utilizing a handheld spectroscopic analysis device in an oral, nasal and upper respiratory examination process (Abstract; col. 3, lines 30 – 35; col. 5, lines 25 – 30). It would have been considered suitable and predictable to a person of ordinary skill in the art to combine the method taught by DeGregorio that collects a blood sample, with the handheld device taught by Wing to confirm each of the detection methods via routine experimentation. The use of a known technique to improve similar devices (methods or products) in the same way is likely to be obvious (see MPEP § 2143, C.). Applying a known technique to a known device (method or product) ready for improvement to yield predictable results is likely to be obvious (see MPEP § 2143, D.). Therefore, it would have been obvious to a person of ordinary skill in the art before the filing date of the claimed invention to provide whereby a single blood sample can be used as a confirmatory test to support a finding of recent cannabis use within the impairment window based on two breath samples.
Regarding claim 4, DeGregorio further teaches whereby the breath/blood ∆9-THC concentration or intensity ratio is calculated as the basis for confirmation (paragraphs 13, 45, 46 and 49).
Claim(s) 6, 7, 10, 13, 14 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over DeGregorio et al. (WO 2019/209649 A1; “DeGregorio”) and Son et al. (WO 2013/062618 A2; “Son”), and further in view of Quirke (US 2018/0153441 A1; “Quirke”).
Regarding claim 6, modified DeGregorio teaches the method of claim 5, whereby the subject is tested for recent cannabis use and impairment by collecting at least one blood sample using a device that automatically collects and stores capillary blood for later laboratory analysis, and by collecting at least one breath sample using a device that traps exhaled breath aerosols for later laboratory analysis (paragraphs 15, 16 and 33).
However, modified DeGregorio does not specifically teach that the breath analyzing device contains an electrostatic polymer filter.
Quirke teaches that breath detectors that are well known in the art for analyzing exhaled breath samples can contain a polymeric electrostatic filter (paragraphs 2 and 8). The combination of familiar elements is likely to be obvious when it does no more than yield predictable results (see MPEP § 2143, A.). Therefore, it would have been obvious to a person of ordinary skill in the art before the filing date of the claimed invention to provide wherein device contains an electrostatic polymer filter for effectively trapping target analytes in the blood sample for analysis.
Regarding claim 7, modified DeGregorio teaches the method of claim 5, whereby the subject is tested for recent cannabis use and impairment by collecting at least one blood sample using a lancet or other means of blood collection, and by collecting at least one breath sample using a device (paragraphs 13, 15, 33 and 71).
However, modified DeGregorio does not specifically teach that the breath analyzing device contains an electrostatic polymer filter.
Quirke teaches that breath detectors that are well known in the art for analyzing exhaled breath samples can contain a polymeric electrostatic filter (paragraphs 2 and 8). The combination of familiar elements is likely to be obvious when it does no more than yield predictable results (see MPEP § 2143, A.). Therefore, it would have been obvious to a person of ordinary skill in the art before the filing date of the claimed invention to provide wherein device contains an electrostatic polymer filter for effectively trapping target analytes in the blood sample for analysis.
Regarding claim 10, modified DeGregorio teaches the method of claim 9, whereby the blood samples are collected using a device that automatically collects and stores capillary blood for later laboratory analysis (paragraph 13), and the breath samples are collected using a device that traps exhaled breath aerosols for later laboratory analysis (paragraphs 15 and 33).
However, modified DeGregorio does not specifically teach that the breath analyzing device contains an electrostatic polymer filter.
Quirke teaches that breath detectors that are well known in the art for analyzing exhaled breath samples can contain a polymeric electrostatic filter (paragraphs 2 and 8). The combination of familiar elements is likely to be obvious when it does no more than yield predictable results (see MPEP § 2143, A.). Therefore, it would have been obvious to a person of ordinary skill in the art before the filing date of the claimed invention to provide wherein device contains an electrostatic polymer filter for effectively trapping target analytes in the blood sample for analysis.
Regarding claim 13, DeGregorio teaches the method of claim 6, whereby the samples are analyzed and assessed using recent use parameters specific for oral consumption of cannabis (paragraphs 45, 46 and 49).
Regarding claim 14, DeGregorio teaches the method of claim 7, whereby the samples are analyzed and assessed using recent use parameters specific for oral consumption of cannabis (paragraphs 45 and 46).
Regarding claim 17, DeGregorio teaches the method of claim 10, whereby the samples are analyzed and assessed using recent use parameters specific for oral consumption of cannabis (paragraphs 45, 46 and 49).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN J. SINES whose telephone number is (571)272-1263. The examiner can normally be reached 9 AM-5 PM EST M-F.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth A Robinson can be reached at (571) 272-7129. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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BRIAN J. SINES
Primary Patent Examiner
Art Unit 1796
/BRIAN J. SINES/Primary Examiner, Art Unit 1796