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 without traverse of Group I in the reply filed on 07/11/2025 is acknowledged.
Claims 1, 8-9, 12, 15-19, 21 and 28-37 are pending.
Claims 8 and 30-34 are withdrawn from consideration as being directed to the non-elected invention.
Claims 1, 9, 12, 15-19, 21, 28-29 and 35-37 are examined.
Copending Applications
Applicants must bring to the attention of the Examiner, or other Office official involved with the examination of a particular application, information within their knowledge as to other copending United States applications, which are "material to patentability" of the application in question. MPEP 2001.06(b). See Dayco Products Inc. v. Total Containment Inc., 66 USPQ2d 1801 (CA FC 2003).
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 12, 15, and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Qin et al (US 7,575,882 B2; Applicant’s IDS).
The claims are drawn to a method of screening a composition for the presence of a cannabinoid or classifying a cannabinoid, by providing cells expressing at least one cannabinoid-activated receptor; adding said composition to the cells; measuring a characteristic of the cells in the presence of the composition, wherein the characteristic results from an interaction between the composition and at least one of the said receptors and is indicative of the presence of a cannabinoid; and identifying the presence of a cannabinoid in the composition based on the results of the measuring step; wherein the composition is a plant extract or is a minor or unknown; wherein characteristic is a binding affinity of the composition to the receptor.
Qin et al teach a method of screening, identifying and characterizing a compound that interacts or modulates the biological activity of a TRPV2 (col. 3, lines 58-61), the method comprising contacting a TRPV2 with a cannabinoid that is capable of activating the TRPV2; wherein the TRPV2 is present in a cell (claim 6); wherein the biological activity is measured as calcium-influx into a cell expressing the TRPV2 (claim 12), or is measured as its binding affinity to the cannabinoid that is capable of activating the TRPV2 activity (claim 15), or functional changes of the cell physiology such as calcium mobilization; the method also comprises adding a test compound to the TRPV2 before, after or simultaneously with the cannabinoid that is capable of activating the TRPV2; measuring the biological activity of the TRPV2 in the presence of both the cannabinoid and the test compound; and measuring the biological activity of the TRPV2 in the presence of the cannabinoid but not the test compound (claim 1). Qin et al teach that cannabinoids include a class of compounds that were originally extracted from the Cannabis sativa plant (column 4, lines 17-19), and that cannabinoids with one and 4 carbons exist but are minor components (column 4, lines 44-47). s(h a binding affinity of the composition to the
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 1, 9, 12, 15-19, 21, 28-29 and 35-37 are rejected under 35 U.S.C. 103 as being unpatentable over Qin et al (US 7, 575, 882 B2) in view of Scotter et al (P.H. Reggio (ed), Springer Science. The Cannabinoid Receptors, The Receptors (2009) 153-171).
The claims are drawn to a method of screening a composition for the presence of a cannabinoid or classifying a cannabinoid, by providing cells expressing at least one cannabinoid-activated receptor; adding said composition to the cells; measuring a characteristic of the cells in the presence of the composition, wherein the characteristic results from an interaction between the composition and at least one of the said receptors and is indicative of the presence of a cannabinoid; and identifying the presence of a cannabinoid in the composition based on the results of the measuring step; wherein the receptor is CB1, CB2, GPR18, GPRSS, GPR119, or TRPV1 and the cannabinoid is minor or unknown; wherein the characteristic is a binding affinity of the composition to the receptor, a change in intracellular levels, a change in a secondary messenger or phosphorylation of a molecule indicated of activation of the cannabinoid-activated receptor; wherein the composition is a plant; wherein the concentrations are cAMP and/or Ca+, the phosphorylation is p38-MAPK phosphorylation; said method further comprising the step of isolating the cannabinoid, and characterizing step comprises mass spectrometry.
Qin et al teach a method of screening, identifying and characterizing a compound that interacts or modulates the biological activity of a TRPV2 (col. 3, lines 58-61), the method comprising contacting a TRPV2 with a cannabinoid that is capable of activating the TRPV2; wherein the TRPV2 is present in a cell (claim 6); wherein the biological activity is measured as calcium-influx into a cell expressing the TRPV2 (claim 12), or is measured as its binding affinity to the cannabinoid that is capable of activating the TRPV2 activity (claim 15), or functional changes of the cell physiology such as calcium mobilization; the method also comprises adding a test compound to the TRPV2 before, after or simultaneously with the cannabinoid that is capable of activating the TRPV2; measuring the biological activity of the TRPV2 in the presence of both the cannabinoid and the test compound; and measuring the biological activity of the TRPV2 in the presence of the cannabinoid but not the test compound (claim 1). Qin et al indicate that methods for measuring a TRPV2 channel conductivity via the cellular depolarization or hyperpolarization or an increase in intracellular Ca+ ion levels are known in the art. Qin et al teach that cannabinoids include a class of compounds that were originally extracted from the Cannabis sativa plant (column 4, lines 17-19), and that cannabinoids with one and 4 carbons exist but are minor components (column 4, lines 44-47). At column 2 lines 46-53, Qin et al provide a step of designing a structural analog of the cannabinoid based on a structural relationship between the TRPV2 and the interacting cannabinoid, and determining the ability of the analog to alter the biological activity of the TRPV2. Qin et al also teach that the structural information on TRPV2-cannbinoid complex can be obtained via mass spectrometry (column 18, lines 4-7). At the paragraph bridging columns 16 and 17, Qin et al teach the ability of a test compound to increase the ion conductivity of a TRPV2 can be determined by an increase in intracellular calcium ion levels. At column 19, lines 59-61, Qin et al teach a method of testing delta 9-THC, a major psychoactive constituent of marijuana derived from cannabis. Other cannabinoid receptors including CB1, CB2 and TRPV1 are well characterized in the art as evidenced by Qin et al (columns 5-6 and 29).
While Qin et al suggest methods of phosphorylation of polypeptides (col.8, lines 6-8), Qin et al do not explicitly teach the phosphorylation of a molecule indicative of activation of the cannabinoid-activated receptor is of p38-MAPK phosphorylation or phosphorylated ERK (pERK).
Scotter et al teach mechanism of CB1 activation of the ERK pathway through cAMP-dependent pathways (Fig. 2) and CB2 activation of p38 MAPK following stimulation by the cannabinoid THC, resulting in the inhibition of tumor cells (paragraph bridging pages 162 and 163). At pages 155 and 156, Qin et al teach CB1 and CB2 cannabinoid receptor mediated signaling in relation to the important role cannabinoid may play in target cell death.
Therefore, it would have been obvious to one of skill in the art a method of screening, identifying and characterizing a compound that interacts or modulates the biological activity of a cannabinoid-receptor by contacting the cannabinoid-receptor with a cannabinoid that is capable of activating the cannabinoid-receptor in cells and measuring the biological activity via calcium inflex into the cell or by binding affinity to the cannabinoid via as taught by Qin et al, given the therapeutic effects of the cannabinoid receptors and its interacting cannabinoid in inducing cell death as taught by Scotter et al. One would have been motivated to study multiple characteristics including signaling profile resulting from the interaction to classify and characterize new cannabinoids as taught by Qin et al, given “the complexity of signaling associated with CB-receptor activation must be considered fully when cannabinoids are to be used therapeutically in order that adverse events are avoided and their therapeutic potential is realized” as stated by Scotter et al.
Therefore, for all the reasons discussed above, the claimed invention is a prima facie obvious, absent evidence to the contrary.
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.
Claim 18 is 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.
Claim 18 is indefinite because “the concentrations” lacks antecedent basis. Correction is required to more clearly define the metes and bounds of the claim.
Remarks
No claim is allowed.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEDINA AHMED IBRAHIM whose telephone number is (571)272-0797. The examiner can normally be reached Monday-Friday, 9:00 - 6:00.
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, SHUBO ZHOU can be reached at 5712720724. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
MEDINA AHMED. IBRAHIM
Primary Examiner
Art Unit 1662
/MEDINA A IBRAHIM/ Primary Examiner, Art Unit 1662