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
1. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 April 27, 2026 has been entered.
Claim Status
2. Claims 1, 3-5, 15, 19, 21, 23-25, 44, and 46-48 are pending and under examination on the merits.
Claims 2, 6-14, 16-18, 20, 22, 26-43, and 45 are cancelled.
Information Disclosure Statement
3. The information disclosure statement (IDS) submitted on April 27, 2026 has been received by the Office and is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Arguments – Claim Objections
4. Applicant’s arguments and amendments filed April 27, 2026 have overcome the objections of record. However, Applicant’s amendments have necessitated new grounds for objections.
Claim 2 has been cancelled; therefore, any objections the claim have been rendered moot.
Claim Objections
5. Claims 15, 19, and 24-25 are objected to for the following reasons:
Claim 15 contains a grammatical error; “culture, and optionally” should be amended to “culture, optionally” because this phrase is not the final embodiment of the listed options.
Claim 24 contains a typographical error; “set for in” should be amended to “set forth in”.
Dependent claims are included. Appropriate correction is required.
Response to Arguments – Claim Rejections - 35 USC § 101
6. Applicant’s arguments and amendments filed April 27, 2026 have overcome the rejections of record. In particular, Applicant’s arguments that the native H. umbraculigerum genes contain introns (pp. 06-07) is persuasive enough to overcome the rejections of record.
However, claims 46-48 are newly rejected under 35 U.S.C. 101 as being directed to a product of nature without significantly more.
Claim Rejections - 35 USC § 101
7. 35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
8. Claims 46-48 are rejected under 35 U.S.C. 101 because the claimed inventions are directed to a product of nature without significantly more.
Independent claim 44 recites an “extract comprising an acyl CoA”. An “extract comprising an acyl CoA” is given the broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The Office notes that one of ordinary skill in the art understands that acyl CoA is ubiquitous and present in the cytosol of all unicellular and multicellular organisms and, therefore, is a natural product. Natural products and processes are not patent-eligible (Association for Molecular Pathology v. Myriad Genetics, Inc., --U.S.--(June 13, 2013)).
Claim 44 is herein assessed for subject matter eligibility under 35 U.S.C. 101 (see: MPEP 2106(III)).
Claim 44 recites a method for obtaining an extract comprising an acyl CoA from a transgenic cell. Claim 44 provides no limitations that make the recited acyl CoA or extract comprising said acyl CoA markedly different from natural products. However, the method of claim 44 requires a component that is not a product of nature (i.e., the transgenic cell of claim 15). Therefore, claim 44 is not directed to a judicial exception without significantly more.
However, claims 46-48 depend from claim 44 and are directed to the products of claim 44 and/or compositions comprised thereof. Accordingly, claims 46-48 are herein assessed for subject matter eligibility under 35 U.S.C. 101 (see: MPEP 2106(III)).
Claim 46 is directed to a product of the method of claim 44 (i.e., an extract comprising an acyl CoA). Though claim 44 requires the acyl CoA be obtained from a transgenic cell, the claim does not limit or define the structure of the acyl CoA, does not limit or define any solution or substance into which the acyl CoA will be extracted, and does not require or recite that the extract or acyl CoA have a structure or feature unique to the transgenic cell. The specification provides no definition limiting the structure or scope of either an extract or an acyl CoA and the claims provide no limitations that make the recited acyl CoA or an extract comprising said acyl CoA markedly different from natural products (i.e., an isolated acyl CoA and/or a cytosolic solution comprising an acyl CoA). Therefore, an “extract comprising an acyl CoA” is broad and encompasses any solution and/or substance comprising any acyl CoA. Accordingly, the “extract comprising an acyl CoA” also encompasses naturally-occurring cytosol and, therefore, is not markedly different from a product of nature.
Claim 47 is directed to a product of the method of claim 44. Though claim requires the medium or a portion thereof be separated from a transgenic cell, the claim does not limit or define the structure of the medium, the specification provides no definition limiting the structure or scope of a medium, and the claim does not require or recite that the medium or a portion thereof have a structure or feature unique to the transgenic cell. The recitation of a “medium or a portion” is broad and encompasses any solution into which a transgenic cell can be suspended. Accordingly, the recited medium encompasses water. Thus, a “medium or a portion” is broad and is not markedly different from a product of nature.
Claim 48 is directed to a composition comprising the extract of claim 46 and an acceptable carrier. The specification defines an “acceptable carrier” as any “non-toxic, inert solid, semi-solid liquid filler, diluent, encapsulating material, formulation auxiliary of any type, or simply a sterile aqueous medium” such as saline, sugars, starches, excipients, oils, glycols, esters, and buffering agents[0157-0158]. The definition of an “acceptable carrier” is broad and encompasses natural products such as water and cytosol, which contains diluents, glycols, saline, and sugars. Neither the claims nor the specification provides any definition limiting the structure of a “composition”. Therefore, a “composition” is interpreted to encompass a mixture and/or solution of at least two substances as would be reasonably interpreted by one of ordinary skill in the art. Accordingly, a composition comprising the extract of claim 46, which is not markedly different from a product of nature, and an acceptable carrier, is not markedly different from a product of nature.
Because the extract, medium, and composition of claims 46-48 lack features that distinguish them from products of nature, claims 46-48 are directed to natural phenomena without significantly more and, therefore, are not patent-eligible.
Response to Arguments – Claim Rejections - 35 USC § 112(a)
9. Applicant’s arguments and amendments filed April 27, 2026 have overcome the rejections of record.
Claim Rejections - 35 USC § 112(b)
10. 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.
11. Claims 4, 46, and 48 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.
The scope of claim 4 is indefinite because it is unclear what is encompassed by an “artificial” nucleic acid. Though Applicant makes several references to artificial nucleic acids and vectors throughout the specification, Applicant does not provide a definition for an “artificial nucleic acid” and this term is not standard in the arts. Accordingly, it is unclear what features are required to make a nucleic acid sequence artificial. What traits distinguish an artificial nucleic acid from a non-artificial nucleic acid? For the purpose of compact prosecution, an “artificial nucleic acid” is herein interpreted to encompass any nucleic acid made via synthetic biology techniques and/or methods. Applicant is required to clarify the intended recitation.
The metes and bounds of claim 46 are indefinite because it is unclear if the claimed extract comprises an acyl CoA or if only the cell from which the extract was obtained comprises an acyl CoA. The presence of multiple reasonable interpretations renders the claim indefinite. For the purpose of compact prosecution, claim 46 is herein interpreted to recite an extract comprising an acyl CoA, wherein the extract was obtained from a transgenic cell according to the method of claim 44. Applicant is required to clarify the intended recitation.
Dependent claims are included. Appropriate correction is required.
Claim Rejections - 35 USC § 112(d)
12. The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
13. Claim 4 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Applicant does not provide a clear or distinct definition for the term “artificial nucleic acid”; therefore, the Office interprets an “artificial nucleic acid” to encompass any nucleic acid produced by synthetic biology techniques. Accordingly, cDNA is interpreted to be an artificial nucleic acid. Therefore, claim 4 fails to further limit claim 1 because cDNA is an artificial nucleic acid.
Applicant may cancel the claim, amend the claim to place the claim in proper dependent form, rewrite the claim in independent form, or present a sufficient showing that the dependent claim complies with the statutory requirements.
Claim Rejections - 35 USC § 103
14. 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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
15. Claims 1, 3-5, 15, 19, and 23-25 are rejected under 35 U.S.C. 103 as being unpatentable over Gülck and Møller (Trends in Plant Science, 2020; 25, 985-1004 (U)) in view of Blatt-Janmaat and Qu (Int. J. Mol. Sci. 2021; 22(5):2454 (V)), and further in view of Watkins et al. (Biochimica et Biophysica Acta. 2012; 1822:1411–1420 (W)).
Regarding claims 1 and 3, Gülck teaches phytocannabinoids as meroterpenoids with a resorcinyl core typically decorated with a para-positioned isoprenyl, alkyl, or aralkyl side chain (p. 985, “Highlight”; p. 985, first full paragraph; pp. 986-987, “Glossary”; p. 986, “Figure 1”), the role of Cannabis sativa acyl-activating enzyme 1 (CsAAE1) and CsAAE2 in cannabinoid biosynthesis and metabolism (p. 1000, Table 1), that cannabinoids from H. umbraculigerum have reduced affinity for the human cellular receptors responsible for the psychotropic response to cannabinoids (p. 987, first full paragraph; p. 991, “Bibenzylic Cannabinoids”, first paragraph), and suggests that the identification of the H. umbraculigerum cannabinoid biosynthesis pathway has use in building new cannabinoid structures (p. 1000, “Outstanding Questions”, first paragraph; p. 1000, “Concluding Remarks and Future Outlook”).
Gülck is silent to SEQ ID NOs:2-4, 6, and 9.
Blatt-Janmaat teaches cannabinoids as meroterpenoids (i.e., partial terpenoid derivatives) with a resorcinyl core featuring a para position isoprenyl, alkyl, or aralkyl side chain produced as specialized metabolites in plants (p. 01, first full paragraph), the medicinal and economic importance of cannabinoids (Abstract), the heterologous production of cannabinoids via synthetic biology (Abstract), the presence of cannabinoids in Helichrysum umbraculigerum (p. 02, first full paragraph), and suggests the presence of cannabinoids in various plant species indicates convergent evolution of cannabinoid biosynthesis pathways (p. 02, first full paragraph).
Watkins teaches multiple conserved domains, including two highly conserved domains, by which acyl-activating enzymes, which are also known in the art as acyl-CoA synthetases, can be recognized (p. 02, paragraph beginning “Identification of ACSs…”).
The combination of Gülck, Blatt-Janmaat, and Watkins teaches the presence of cannabinoid biosynthesis genes (i.e., nucleic acid sequences) encoding enzymes with acyl-activating activity in H. umbraculigerum, provides motivation to identify those H. umbraculigerum acyl-activating enzymes (AAEs), and teaches conserved protein domains that can be used to identify AAEs.
The level of ordinary skill in the plant biotechnology art is high as evidenced by both Gülck and Blatt-Janmaat. One of ordinary skill in the art would have been motivated to isolate and clone cDNA of SEQ ID NOs:2-4, 6, and 9 because of the significant medical and economic incentive to develop additional methods and resources for producing cannabinoids and the state of the art teaches that cannabinoids from H. umbraculigerum have reduced psychotropic effects in comparison to cannabinoids from C. sativa. Furthermore, Gülck suggests the usefulness of H. umbraculigerum cannabinoid biosynthesis enzymes in building new cannabinoid structures and both Gülck and Blatt-Janmaat teach the presence of a cannabinoid biosynthesis pathway and, therefore, cannabinoid biosynthesis genes in H. umbraculigerum. Thus, one of ordinary skill in the art would have been sufficiently motivated to isolate the H. umbraculigerum nucleic acid sequences encoding functional proteins with acyl-activating enzyme activity. Additionally, Blatt-Janmaat suggests that cannabinoid biosynthesis enzymes convergently evolved in different species; therefore, one of ordinary skill in the art would assume, with a reasonable expectation of success, that H. umbraculigerum AAEs that share a significant degree of sequence homology to C. sativa AAEs (e.g., CsAAE1) similarly function in cannabinoid biosynthesis. Because Watkins teaches highly conserved residues by which AAEs can be identified, one of ordinary skill in the art would have been able, with a reasonable expectation of success, to identify AAEs in H. umbraculigerum based on the recognition of the protein domains conserved among AAEs. The instant specification indicates SEQ ID NOs:2-4, 6, and 9 were cloned from H. umbraculigerum total RNA without further modification (pp. 47-48 “RNA sequencing and genome annotation of H. umbraculigerum”; pp. 49-50, Example 2). Based on the combined teachings of Gülck, Blatt-Janmaat, and Watkins, it would have been prima facie obvious for one of ordinary skill in the art to identify the nucleic acid sequences encoding H. umbraculigerum AAEs involved in cannabinoid biosynthesis, which comprises mRNAs complementary to SEQ ID NOs:2-4, 6, and 9, isolate said mRNA, and clone complementary DNA (cDNA) molecules from the mRNA sequences for the production of cannabinoids. The cloning and isolation of cDNA is routine in the biological arts; one of ordinary skill in the art can produce a library of cDNAs from virtually any known organism without any surprising or unexpected results. Accordingly, one of ordinary skill in the art would have been motivated to produce the claimed invention with a reasonable expectation of success and without any surprising or unexpected results.
Regarding claim 4, the combined teachings of Gülck, Blatt-Janmaat, and Watkins are as discussed above. Gülck is silent to artificial nucleic acids. However, Gülck suggests the heterologous expression of cannabinoid biosynthesis genes (Gülck: p. 1000-1001, “Concluding Remarks and Future Outlook”, second paragraph), which inherently requires synthetic/artificial nucleic acids (i.e., plasmids, expression vectors, and/or cloned nucleic acids). Furthermore, Blatt-Janmaat teaches the transient expression of CsAAE1 in tobacco (Blatt-Janmaat: p. 14, first partial paragraph), which requires plasmid expression vectors (i.e., an artificial nucleic acid) and agrobacterium.
Regarding claim 5, the combined teachings of Gülck, Blatt-Janmaat, and Watkins are as discussed above. Gülck teaches the heterologous production of cannabinoids (Gülck: p. 1000-1001, “Concluding Remarks and Future Outlook”, second paragraph) and Blatt-Janmaat teaches transgenic S. cerevisiae and N. benthamiana (Blatt-Janmaat: p. 13, “5. Choice of Chassis and Further Technical Development”, first paragraph). Both the heterologous production of cannabinoids and the generation of transgenic yeast and tobacco inherently requires plasmid and/or agrobacterium vectors. Therefore, in addition to the teachings discussed above, the combination of Gülck, Blatt-Janmaat, and Watkins teaches a plasmid or agrobacterium.
Regarding claim 15, the combined teachings of Gülck, Blatt-Janmaat, and Watkins are as discussed above. Gülck teaches the heterologous production of cannabinoids (Gülck: p. 1000-1001, “Concluding Remarks and Future Outlook”, second paragraph) and the production and extraction of cannabinoids from S. cerevisiae (p. 997, “Biotechnological Production of Phytocannabinoids in Heterologous Hosts”). Blatt-Janmaat teaches transgenic S. cerevisiae and N. benthamiana (Blatt-Janmaat: p. 13, “5. Choice of Chassis and Further Technical Development”, first paragraph). Therefore, the combination of Gülck, Blatt-Janmaat, and Watkins teaches transgenic cells wherein said transgenic cell is any one of a unicellular organism or a cell of a multicellular organism, wherein the unicellular organism is a fungus, and wherein the fungus is a yeast cell.
Regarding claim 19, in addition to the teachings discussed above, Gülck teaches the identification of more than 113 different cannabinoids from C. sativa (p. 985, “Phytocannabinoids”, second paragraph) and the production and extraction of cannabinoids from S. cerevisiae (p. 997, “Biotechnological Production of Phytocannabinoids in Heterologous Hosts”). Therefore, the combination of Gülck, Blatt-Janmaat, and Watkins renders obvious these claim limitations.
Regarding claim 23, Applicant has provided no definition limiting the scope of a composition. In teaching isolated cDNA molecules, the combination of Gülck, Blatt-Janmaat, and Watkins teaches a composition comprising said molecules and an acceptable carrier, because the solution in which the molecules are synthesized is a composition which functions as an acceptable carrier (i.e., a non-toxic, inert material, aqueous medium, or saline; see Applicant’s specification[0158]).
Regarding claim 24, the combined teachings of Gülck, Blatt-Janmaat, and Watkins are as discussed above.
Gülck teaches the production and extraction of cannabinoids from S. cerevisiae (p. 997, “Biotechnological Production of Phytocannabinoids in Heterologous Hosts”) and the use of H. umbraculigerum cannabinoid biosynthesis proteins for the synthesis of cannabinoids via synthetic biology (Abstract; p. 1000, “Outstanding Questions”, first paragraph; p. 1000, “Concluding Remarks and Future Outlook”).
Regarding claim 25, the function and/or activity of an enzyme is inherent to its sequence. Therefore, in addition to the teachings discussed above, Gülck teaches wherein said protein is characterized by having an acyl-activating enzymatic activity.
Accordingly, one of ordinary skill in the art would have been motivated to produce the claimed invention with a reasonable expectation of success and without any surprising or unexpected results.
16. Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Gülck and Møller (Trends in Plant Science, 2020; 25, 985-1004 (U)) in view of Blatt-Janmaat and Qu (Int. J. Mol. Sci. 2021; 22(5):2454 (V)), further in view of Watkins et al. (Biochimica et Biophysica Acta. 2012; 1822:1411–1420 (W)), and further in view of Feeney and Punja (In Vitro Cell Dev Biol-Plant. 2003; 39:578–585 (X)).
Regarding claim 21, the combined teachings of Gülck, Blatt-Janmaat, and Watkins are as discussed above. Gülck teaches the heterologous production of cannabinoids (Gülck: p. 1000-1001, “Concluding Remarks and Future Outlook”, second paragraph) and Blatt-Janmaat teaches transgenic S. cerevisiae and transgenic N. benthamiana plants (Blatt-Janmaat: p. 13, “5. Choice of Chassis and Further Technical Development”, first paragraph). Therefore, in addition to the teachings discussed above, the combination of Gülck, Blatt-Janmaat, and Watkins teaches a transgenic plant.
Gülck is silent to transgenic C. sativa.
However, Feeney teaches the agrobacterium-mediated transformation of C. sativa for the introduction of foreign genes into the species to develop new cultivars with improved traits (Abstract).
The level of ordinary skill in the plant biotechnology art is high as evidenced by Gülck, Blatt-Janmaat, and Feeney. For the reasons stated above in the rejection of claims 1, 3-5, 15, 19, and 23-25 under 35 U.S.C. 103, it would have been prima facie obvious to one of ordinary skill in the art to combine the teachings of Gülck, Blatt-Janmaat, and Watkins to produce a transgenic cell expressing the recited nucleic acid sequences encoding functional acyl-activating enzymes (i.e., acyl CoAs; see: rejection of claims 1 and 15 under 35 U.S.C. 103, above). It would have been prima facie obvious to further modify the teachings of Gülck, Blatt-Janmaat, and Watkins by the teachings of Feeney to produce a transgenic C. sativa plant expressing functional acyl CoA proteins for the heterologous production of cannabinoids. One of ordinary skill would have been motivated to generate transgenic C. sativa plants because the cannabinoid biosynthetic pathway in C. sativa is well-characterized, C. sativa is highly suitable for the production of cannabinoids, and Feeney suggests that C. sativa could be modified to produce cultivars with improved traits. Furthermore, the cannabinoid and cannabis industries have global economic and medical impact. Accordingly, one of ordinary skill in the art would have been motivated to produce the claimed invention with a reasonable expectation of success and without any surprising or unexpected results.
17. Claims 44 and 46-48 are rejected under 35 U.S.C. 103 as being unpatentable over Gülck and Møller (Trends in Plant Science, 2020; 25, 985-1004 (U)) in view of Blatt-Janmaat and Qu (Int. J. Mol. Sci. 2021; 22(5):2454 (V)), further in view of Watkins et al. (Biochimica et Biophysica Acta 1822. 2012:1411–1420 (W)), and further in view of Stout (The Plant Journal. 2012; 71:353-365 (Y)).
Regarding claim 44, the combined teachings of Gülck, Blatt-Janmaat, and Watkins are as discussed above. Gülck also teaches the identification of more than 113 different cannabinoids from C. sativa (p. 985, “Phytocannabinoids”, second paragraph), the extraction of cannabinoids from C. sativa (p. 986, right column, “Glossary”), and the production and extraction of cannabinoids from S. cerevisiae (p. 997, “Biotechnological Production of Phytocannabinoids in Heterologous Hosts”).
Gülck does not teach obtaining an extract comprising acyl CoA.
Blatt-Janmaat teaches the in vitro production of cannabinoids and the biosynthesis of hexanoyl CoA (p. 14, second full paragraph)
Stout teaches a method for obtaining an extract comprising hexanoyl-CoA from C. sativa comprising culturing a transgenic cell in a medium and separating said transgenic cell from said medium and extracting an acyl CoA from the medium (Abstract; p. 363, “Recombinant protein expression, purification and assay”, first paragraph) and a composition of acyl CoAs, glycerol, and salts in 50mM HEPES buffer (i.e., an acceptable carrier; p. 363, “Recombinant protein expression, purification and assay”, first paragraph).
The combination of Gülck, Blatt-Janmaat, Watkins, and Stout teaches a method for obtaining an extract comprising an acyl CoA from a transgenic cell comprising culturing the transgenic cell in a medium, separating said transgenic cell from said medium, and extracting an acyl CoA from the medium, thereby obtaining an extract comprising an acyl CoA from the transgenic cell.
The level of ordinary skill in the plant biotechnology art is high as evidenced by Gülck, Blatt-Janmaat, and Stout. The recitation of an “extract comprising an acyl CoA” is given the broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. Though the claim requires the extract be obtained from a transgenic cell, the claim does not limit or define the structure of the acyl CoA, does not limit or define any solution or substance into which the acyl CoA will be extracted, and does not require nor recite that the extract or acyl CoA have some structure or feature unique to the transgenic cell. The specification provides no definition limiting the structure or scope of either an extract or an acyl CoA; therefore, an “extract comprising an acyl CoA” is broadly and reasonably interpreted to encompass any solution and/or substance comprising an acyl CoA. For the reasons stated above in the rejection of claims 1, 3-5, 15, 19, and 23-25 under 35 U.S.C. 103, it would have been prima facie obvious to one of ordinary skill in the art to combine the teachings of Gülck, Blatt-Janmaat, and Watkins to produce a transgenic cell expressing the recited nucleic acid sequences encoding functional acyl-activating enzymes (i.e., acyl CoAs; see: rejection of claims 1 and 15 under 35 U.S.C. 103, above). It would have been prima facie obvious to further modify the teachings of Gülck, Blatt-Janmaat, and Watkins by the teachings of Stout to extract acyl CoAs from transgenic cells expressing cannabinoids. One of ordinary skill would have been motivated to extract acyl CoAs from a transgenic cell expressing said acyl CoAs to develop an in vitro system for the synthesis of cannabinoids because the cannabis and cannabinoid industries have global economic and medical importance and cannabis is an illicit plant in many countries. Therefore, one of ordinary skill in the art would be sufficiently motivated to develop a method for synthesizing cannabinoids independently of the highly-regulated cannabis plant. Additionally, protein extraction is routine in the art, and well within the ability of one of ordinary skill in the art, as demonstrated by Stout’s identification and extraction of hexanoyl CoA from C. sativa. Furthermore, Blatt-Janmaat teaches the suitability of in vitro expression systems for the production of cannabinoids. Accordingly, one of ordinary skill in the art would have been motivated to produce the claimed invention with a reasonable expectation of success and without any surprising or unexpected results.
Regarding claim 46, the combined teachings of Gülck, Blatt-Janmaat, Watkins, and Stout are as discussed above. Gülck is silent to an extract comprising an acyl CoA. However, Stout teaches an extract comprising hexanoyl-CoA from C. sativa (Abstract; p. 363, “Recombinant protein expression, purification and assay”, first paragraph). Therefore, the combined teachings of Gülck, Blatt-Janmaat, Watkins, and Stout teach an extract comprising an acyl CoA.
Regarding claim 47, in addition to the teachings discussed above, Gülck teaches the production and extraction of cannabinoids from S. cerevisiae (p. 997, “Biotechnological Production of Phytocannabinoids in Heterologous Hosts”). Neither the claims nor the specification provides any definition limiting the scope of a “medium or a portion thereof” separated from a transgenic cell. The extraction of cannabinoids from S. cerevisiae inherently requires the separation of the medium and/or portions thereof from the yeast cells. Therefore, Gülck renders obvious this claim limitation.
Regarding claim 48, in addition to the teachings discussed above, Gülck teaches the production and extraction of cannabinoids from S. cerevisiae (p. 997, “Biotechnological Production of Phytocannabinoids in Heterologous Hosts”). The specification defines an “acceptable carrier” as any “non-toxic, inert solid, semi-solid liquid filler, diluent, encapsulating material, formulation auxiliary of any type, or simply a sterile aqueous medium” such as saline, sugars, starches, excipients, oils, glycols, esters, and buffering agents[0157-0158]. Therefore, the scope of an acceptable carrier is broad and the solution into the which the composition taught by Gülck is extracted functions as an acceptable carrier. Furthermore, Stout teaches a composition of acyl CoAs, glycerol, and salts in 50mM HEPES buffer (i.e., an acceptable carrier; p. 363, “Recombinant protein expression, purification and assay”, first paragraph). Therefore, the combination of Gülck, Blatt-Janmaat, Watkins, and Stout renders obvious this claim limitation.
Accordingly, one of ordinary skill in the art would have been motivated to produce the claimed invention with a reasonable expectation of success and without any surprising or unexpected results.
Conclusion
18. No claim is allowed.
Examiner’s Contact Information
19. Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEQUANTARIUS J SPEED whose telephone number is (703)756-4779. The examiner can normally be reached M-F; 9AM-5PM ET.
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/DEQUANTARIUS JAVON SPEED/Junior Examiner, Art Unit 1663
/Amjad Abraham/SPE, Art Unit 1663
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