The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
1. Applicants’ on 4/22/26 filed an election response to restriction requirement mailed 2/25/26 by presenting new set of claims 34-53 which claims are not representative of the prior claims filed. Hence a telephone call was made on 5/15/26 by presenting new Groups I-III as follows.
Group I claims 34-49 (method), Group II claims 50-52 (method) and Group III claim 53 (cell, product).
In response to the new groups, Applicant’s representative Paul L. Weaver’s election over the telephone of Group I (claims 34-49) & species election of SEQ ID Nos. 1, 2, 3 & 10 on 3/22/2010 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 § 818.03(a)).
2. Claims withdrawn:
Claims 50-53 and non-elected sequences from claims 34-49 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
3. Priority
Applicant’s claim for domestic priority under 35 U.S.C. 119(e), filed 3/2/22 & 9/1/21, is acknowledged.
4. Drawings
The drawings filed on 2/27/24 are acknowledged.
5. Specification
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant's cooperation is requested in correcting any errors of which applicant may become aware in the specification.
6. IDS(s) filed 5/10/24, 5/14/24 & 6/7/25 are acknowledged. Signed copies of the IDS(s) are provided with this Office Action.
7. Claims 34-49 are as follows:
34. (New) A method of making a cannabinoid comprising:contacting a prenylated aromatic compound with a flavin-dependent oxidase having at least 70% sequence identity to any one of SEQ ID NOs:1-3, any one of SEQ ID NOs:10-13, or any one of SEQ ID NOs:17-19,wherein contacting converts the prenylated aromatic compound into a cannabinoid by oxidative cyclization.
35. (New) The method of claim 34 wherein contacting converts:cannabigerolic acid (CBGA) into one or more of cannabichromenic acid (CBCA), cannabidiolie acid (CBDA), and/or tetrahydrocannabino lic acid (THCA);cannabigerorcinic acid (CBGOA) into one or more of cannabiorcichromenic acid (CBCOA), cannabidiorcinic acid (CBDOA), and/or tetrahydrocannabiorcinic acid (THCOA);cannabigerivarinic acid (CBGVA) into one or more of cannabichromevarinic acid (CBCVA), cannabidivarinic acid (CBDVA), and/or tetrahydrocannabivarinic acid (THCVA);cannabigerorcinol (CBGO) into one or more of cannabichromeorcin (CBCO), cannabidiorcin (CBDO), and/or tetrahydrocannabiorcin (THCO);cannabigerivarinot (CBGV) into one or more of cannabichromevarin (CBCV), cannabidivarin (CBDV), and/or tetrahydrocannabivarin (THCV); and/or cannabigerol (CBG) into one or more of cannabichromene (CBC), cannabidiol (CBD), and/or tetrahydrocannabinol (THC).
36. (New) The method of claim 34 wherein flavin-dependent oxidase is produced in bacteria.
37. (New) The method of claim 34 wherein flavin-dependent oxidase is expressed in an engineered cell from an exogenous nucleic acid that encodes the flavin-dependent oxidase.
38. (New) The method of claim 36 wherein flavin-dependent oxidase is purified from bacteria and contacting is performed an in vitro reaction medium.
39. (New) The method of claim 38 wherein the in vitro reaction medium comprises a surfactant in an amount in the range of about 0.01% (v/v) to about 1% (v/v), optionally wherein the surfactant is 2-[4-(2,4,4-trimethylpentan-2-yl)phenoxy]ethano.
40. (New) The method of claim 38 wherein the contacting occurs at pH in the range of about pH 4 to about pH 9, or about about pH 5 to about pH 8.
41. (New) The method of claim 37 wherein contacting occurs in a cell culture medium.
42. (New) The method of claim 41 wherein flavin-dependent oxidase contact converts the prenylated aromatic compound into a cannabinoid intracellularly.
43. (New) The method of claim 34 wherein the pH of the cell culture medium is in the range of 6 to 8.
44. (New) The method of claim 43 wherein the engineered cell further comprises a cannabinoid biosynthesis pathway enzyme.
45. (New) The method of claim 44 wherein the cannabinoid biosynthesis pathway enzyme comprises one or more of an olivetol synthase (OLS), olivetolic acid cyclase (OAC), geranyl pyrophosphate (GPP) pathway enzyme, and/or prenyltransferase.
46. (New) The method of claim 34 wherein contacting converts the prenylated aromatic compound into different isomers of the cannabinoid, and the amount of the different isomers is adjusted by altering the pH of an in vitro reaction medium or cell culture.
47. (New) The method of claim 34 wherein the flavin-dependent oxidase has at least 90% sequence identity to any one of SEQ ID NOs:1-3, any one of SEQ ID NOs:10-13, or any one of SEQ ID NOs: 17-19.
48. (New) The method of claim 34 wherein the flavin-dependent oxidase has at least 95% sequence identity to any one of SEQ ID NOs:1-3, any one of SEQ ID NOs:10-13, or any one of SEQ ID NOs:17-19.
49. (New) The method of claim 34 wherein the flavin-dependent oxidase comprises or consists of SEQ ID NO:1, SEQ ID NO:2, SEQ ID NO:3, or SEQ ID NO: 10.
8. 35 U.S.C. § 112, first paragraph (Written Description)
Claims 34-47 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), 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 or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claimed invention is directed to the following genus claims. A method of making a cannabinoid comprising: contacting a prenylated aromatic compound with a flavin-dependent oxidase having at least 70% or 90% sequence identity to any one of SEQ ID NOs:1-3, any one of SEQ ID NOs:10-13, or any one of SEQ ID NOs:17-19, wherein contacting converts the prenylated aromatic compound into a cannabinoid by oxidative cyclization.
The method claims are drawn to flavin-dependent oxidase sequences of the elected sequences of SEQ ID Nos. 1-3 & 10 comprising at least 10% or 30% modification while no mutants/variants are detailed in the instant specification. The claimed invention encompasses a genus of flavin-dependent oxidase not adequately described.
The instant specification and considering the skill of an artisan would be able to construct and modify sequences by at least 5% or modify sequences of SEQ ID Nos. 1-3 & 10 by about 23 amino acids, considering the polypeptide sequence of SEQ ID NO: 2 to be 473 amino acids in length.
Further where in the method of claim 34 that converts:cannabigerolic acid (CBGA) into one or more of cannabichromenic acid (CBCA), cannabidiolie acid (CBDA), and/or tetrahydrocannabino lic acid (THCA);cannabigerorcinic acid (CBGOA) into one or more of cannabiorcichromenic acid (CBCOA), cannabidiorcinic acid (CBDOA), and/or tetrahydrocannabiorcinic acid (THCOA);cannabigerivarinic acid (CBGVA) into one or more of cannabichromevarinic acid (CBCVA), cannabidivarinic acid (CBDVA), and/or tetrahydrocannabivarinic acid (THCVA);cannabigerorcinol (CBGO) into one or more of cannabichromeorcin (CBCO), cannabidiorcin (CBDO), and/or tetrahydrocannabiorcin (THCO);cannabigerivarinot (CBGV) into one or more of cannabichromevarin (CBCV), cannabidivarin (CBDV), and/or tetrahydrocannabivarin (THCV); and/or cannabigerol (CBG) into one or more of cannabichromene (CBC), cannabidiol (CBD), and/or tetrahydrocannabinol (THC) is unlikely to catalyze the reactions.
The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed by him. The courts have stated:
"To fulfill the written description requirement, a patent specification must describe aninvention and do so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997); In re Gostelli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) ("[T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what isclaimed."). Thus, an applicant complies with the written description requirement "bydescribing the invention, with all its claimed limitations, not that which makes it obvious,"and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966."Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
Further, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. In Regents" of the University of California v. Eli Lilly & Co. the court stated:
"A written description of an invention involving a chemical genus, like a description of a chemical species, 'requires a precise definition, such as by structure, formula, [or] chemical name,' of the claimed subject matter sufficient to distinguish it from other materials." Fiers, 984 F.2d at 1171, 25 USPQ2d 1601; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284985 (CCPA 1973) ("In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus ...") Regents" of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The MPEP further states that if a biomolecule is described only by a functional characteristic, without any disclosed correlation between function and structure of the sequence, it is "not sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence." MPEP § 2163. The MPEP does state that for a generic claim the genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. MPEP § 2163. If the genus has a substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within that genus. See MPEP § 2163. Although the MPEP does not define what constitute a sufficient number of representative species, the courts have indicated what do not constitute a representative number of species to adequately describe a broad generic. In Gostelli, the courts determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gostelli, 872, F.2d at 1012, 10 USPQ2d at 1618. The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the Application. These include "level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed species is sufficient." MPEP § 2163. While all of the factors have been considered, a sufficient amount for a prima facie case is discussed below.
Further, to provide evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include: a) the scope of the invention; b) actual reduction to practice; c) disclosure of drawings or structural chemical formulas; d) relevant identifying characteristics including complete structure, partial structure, physical and/or chemical properties, and structure/function correlation; e) method of making the claimed compounds; f) level of skill and knowledge in the art; and g) predictability in the art.
Moreover, Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir.1991), states that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed" (See page 1117). The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed" (See Vas-Cath at page 1116). The skilled artisan cannot envision the detailed chemical structure of the encompassed genus of polypeptides, and therefore, conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993).
Therefore, for all these reasons the specification lacks adequate written description, and one of skill in the art cannot reasonably conclude that the applicant had possession of the claimed invention at the time the instant application was filed.
9. Claim Rejections - 35 USC § 112 (second paragraph)
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 39 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 pre-AIA the applicant regards as the invention.
The use of the expression “optionally” (claim 39), attempts to give both broad and narrow meaning to the scope of the above claims. The claim is unclear.
11. US 20250290048 A1 is Applicants’ published application.
12. No claim is allowed.
13. Any inquiry concerning this communication or earlier communications from the examiner should be directed to TEKCHAND SAIDHA whose telephone number is (571)272-0940. The examiner can normally be reached on M-F 8.00-5.30. 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, Robert B Mondesi can be reached on 408 918 7584. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/TEKCHAND SAIDHA/
Primary Examiner, Art Unit 1652
Recombinant Enzymes, Hoteling
Telephone: (571) 272-0940
Fax: (571) 273-0940
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