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 with traverse of Group I (claims 1-11, 16, and 17) in the reply filed on April 6th, 2026 is acknowledged. The traversal is on the grounds that the cited Rowles reference (US 20190224327-A1) nowhere makes any mention of any camphene, any terpene, or any bisabolol, and therefore does not recite all the elements of the independent claims. The applicant also alleges that the Patent Office has here conflated traditional restriction practice under 37 CFR 1.141-1.146 and the unity of invention standard under 37 CFR 1.475-1.485. The applicant also alleges the misapplication of 37 CFR 1.475(e). The applicant also alleges the importation of restriction concepts of 35 U.S.C. 121 and 37 CFR 1.141. The applicant also implies that the Patent Office has failed at "demonstrating with documentary evidence that the claimed alleged special technical feature lacks novelty or inventive step over the prior art". This is not found persuasive because upon further consideration the claims still lack unity of invention because the shared technical feature does not make contribution over the prior art Alugupalli (WO 2020163775 A1) claims 1 and 3 (see 35 U.S.C. 103 rejection below); therefore, Groups I-III still lack unity of invention. Claims 12-15 and 18-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on April 6th, 2026.
The requirement is still deemed proper and is therefore made FINAL.
Applicant’s election of cannabigerol (claim 3) and "bisobolol", interpreted as referring to alpha-bisabolol (claim 16), in the reply filed on April 6th, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the election of species requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Claims 2, 4-11, and 17 are withdrawn as being drawn to non-elected species.
Claims 1, 3, and 16 are pending and were examined on the merits.
Drawings
The drawings filed on February 2nd, 2024 are objected to because, in Figure 3, the CI values are partly illegible because of inadequate resolution, and because there are axis labels in Figure 3 that are occluded by other visual features. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The use of the terms Epidiolex, Sigma Aldrich, Lancaster, Fluorochem, TCI, and IVIS, each of which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore, the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
The disclosure is objected to because of the following informalities: there should be a space between numbers and their respective unit "M".
Appropriate correction is suggested.
Claim Objections
Claims 1 and 3 are objected to because of the following informalities: there should be a space between numbers and their respective unit "M". Appropriate correction is suggested.
Claim Interpretation
The claims in this application are given their 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.
When instant claim 1 recites “A pharmaceutical drug formulation for administration to a patient in need thereof, comprising one or more cannabinols selected from the group consisting of:”, a cannabinol is interpreted as a single chemical species. Therefore, the explicitly recited cannabinols of cannabidiol, cannabigerol, cannabichromene are considered alternatives to both each other and to the pharmaceutically acceptable salts, esters, solvates, optical isomers, and geometric isomers of each of these explicitly recited cannabinols as recited in instant claim 1.
When instant claim 1 recites “A pharmaceutical drug formulation for administration to a patient in need thereof, comprising one or more cannabinols selected from the group consisting of: … and further comprising one or more terpenes selected from the group consisting of:”, a terpene is interpreted as a single chemical species. Therefore, the explicitly recited terpenes of a-terpinene, bisabolol, and camphene are considered alternatives to both each other and to the pharmaceutically acceptable salts, esters, solvates, optical isomers, and geometric isomers of each of these explicitly recited terpenes as recited in instant claim 1.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 3, and 16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/957671 (reference application; US 2025/0161332 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following overlapping subject matter.
Instant claim 1 and 3 and reference claim 1 both recite a pharmaceutical drug formulation for administration to a patient in need thereof, comprising one or more cannabinols selected from the group consisting of: cannabidiol and the pharmaceutically acceptable salts, esters, solvates, optical isomers, and geometric isomers thereof, present in a molar concentration of from 0.03 M to 3.0 M; cannabigerol and the pharmaceutically acceptable salts, esters, solvates, optical isomers, and geometric isomers thereof, present in a molar concentration of from 0.006 M to 0.6 M; cannabichromene and the pharmaceutically acceptable salts, esters, solvates, optical isomers, and geometric isomers thereof, present in a molar concentration of from 0.006 M to 0.6 M; and one or more non-cannabinol constituents selected from a group comprising: bisabolol and the pharmaceutically acceptable salts, esters, solvates, optical isomers, and geometric isomers thereof, present in a molar concentration of from 0.021 M to 2.1 M; and camphene and the pharmaceutically acceptable salts, esters, solvates, optical isomers, and geometric isomers thereof, present in a molar concentration of from 0.022 M to 2.2 M.
Instant claims 1 and 16 and reference claim 1 both recite a pharmaceutical drug formulation for administration to a patient in need thereof comprising bisabolol.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Rejections - 35 USC § 101
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.
Claims 1, 3, and 16 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more. The claims recite a drug formulation comprising one or more cannabinols selected from cannabidiol, cannabigerol, cannabichromene, a-terpinene, bisabolol, and camphene, and the pharmaceutically acceptable salts, esters, solvates, optical isomers, and geometric isomers thereof (claim 1); wherein cannabigerol is present (claim 3), and further comprising alpha-bisabolol. This judicial exception is not integrated into a practical application because the recited combination of chemical compounds is not recited as having characteristics that are markedly different from the naturally occurring source materials of cannabidiol, cannabigerol, cannabichromene, a-terpinene, and bisabolol. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims to not recite bioactive properties that markedly differentiate the instantly claimed drug formulation from the naturally occurring source materials of compounds comprising the formulation.
The first step of the eligibility analysis evaluates whether the claim falls within a statutory category (see MPEP 2106.03). Since claims 1, 3, and 16 are directed to a drug formulation, the claims are directed to a composition.
Effective January 7, 2019, subject matter eligibility determinations under 35 U.S.C. § 101 follow
the procedure explained in the Federal Register notice titled 2019 Revised Patent Subject Matter
Eligibility Guidance (Federal Register, Vol. 84, No.4, 50-57), which is found at:
https://www.govinfo.gov/content/pkg/FR-2019-01-07/pdf/2018-28282.pdf. Applicants are kindly asked
to review this guidance as well as MPEP 2106.
The statutory categories of invention under 35 U.S.C. 101 are processes, machines,
manufactures, and compositions of matter. However, certain members of these categories constitute judicial exceptions, i.e., the courts have determined that these entities are not patentable subject
matter. These judicial exceptions include abstract ideas, laws of nature, and natural phenomena. The
Office released guidance on December 16, 2014 for the examination of claims reciting natural products
under 35 U.S.C. 101 in light of the recent Supreme Court decisions in Association for Molecular
Pathology v. Myriad Genetics, Inc. (569 U.S. ___, 133 S. Ct. 2107, 2116, 106 USPQ2d 1972 (2013)) and
Mayo Collaborative Services v. Prometheus Laboratories (566 U.S. ___, 132 S. Ct. 1289, 101 USPQ2d
1961 (2012)), Diamond v. Chakrabarty, 447 U.S. 303 (1980)) and Funk Brothers Seed Co. v. Kalo Inoculant Co. - 333 U.S. 127 (1948)). (inter alia). See eg. MPEP 2106.04(b)
The Supreme Court has explained that the judicial exceptions reflect the Court’s view
that abstract ideas, laws of nature, and natural phenomena are "the basic tools of scientific and
technological work", and are thus excluded from patentability because "monopolization of those
tools through the grant of a patent might tend to impede innovation more than it would tend to
promote it." Alice Corp., 134 S. Ct. at 2354, 110 USPQ2d at 1980 (quoting Myriad, 133 S. Ct. at
2116, 106 USPQ2d at 1978 and Mayo Collaborative Servs. v. Prometheus Labs. Inc., 566 U.S.
66, 71, 101 USPQ2d 1961, 1965 (2012)). The Supreme Court’s concern that drives this
"exclusionary principle" is pre-emption. Alice Corp., 134 S. Ct. at 2354, 110 USPQ2d at 1980.
The Court has held that a claim may not preempt abstract ideas, laws of nature, or natural
phenomena; i.e., one may not patent every "substantial practical application" of an abstract
idea, law of nature, or natural phenomenon, even if the judicial exception is narrow.
While preemption is the concern underlying the judicial exceptions, it is not a standalone
test for determining eligibility. Rapid Litig. Mgmt. v. CellzDirect, Inc., 827 F.3d 1042, 1052, 119
USPQ2d 1370, 1376 (Fed. Cir. 2016). Instead, questions of preemption are inherent in and
resolved by the two-part framework from Alice Corp. and Mayo (the Alice/Mayo test referred to
by the Office as Steps 2A and 2B). It is necessary to evaluate eligibility using the Alice/Mayo
test, because while a preemptive claim may be ineligible, the absence of complete preemption
does not demonstrate that a claim is eligible.
Products of Nature: When a law of nature or natural phenomenon is claimed as a
physical product, the courts have often referred to the exception as a "product of nature".
Products of nature are considered to be an exception because they tie up the use of naturally
occurring things, but they have been labeled as both laws of nature and natural phenomena.
See Myriad 133 S. Ct. at 2116-17, 106 USPQ2d at 1979 (claims to isolated DNA held ineligible because they "claim naturally occurring phenomena" and are "squarely within the law of nature
exception"); Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130, 76 USPQ 280, 281
(1948) (claims to bacterial mixtures held ineligible as "manifestations of laws of nature" and
"phenomena of nature"). Step 2A of the Office’s eligibility analysis uses the terms "law of
nature" and "natural phenomenon" as inclusive of "products of nature".
It is important to keep in mind that product of nature exceptions include both naturally
occurring products and non-naturally occurring products that lack markedly different
characteristics from any naturally occurring counterpart. Instead, the key to the eligibility of all
non-naturally occurring products is whether they possess markedly different characteristics from
its closest naturally occurring counterpart.
When a claim recites a nature-based product limitation, examiners use the markedly
different characteristics analysis discussed in MPEP § 2106.04(c) to evaluate the nature-based
product limitation and determine the answer to Step 2A. Nature-based products, as used herein,
include both eligible and ineligible products and merely refer to the types of products subject to
the markedly different characteristics analysis used to identify product of nature exceptions.
The Markedly Different Characteristics Analysis
The markedly different characteristics analysis is part of Step 2A, because the courts use this
analysis to identify product of nature exceptions. If the claim includes a nature-based product
that has markedly different characteristics, then the claim does not recite a product of nature
exception and is eligible. If the claim includes a nature-based product that does not exhibit
markedly different characteristics from its closest naturally occurring counterpart in its natural
state, then the claim is directed to a "product of nature" exception (Step 2A: [YES]), and requires
further analysis in Step 2B to determine whether any additional elements in the claim add
significantly more to the exception.
Nature-based Product Claim Analysis
Where the claim is to a nature-based product by itself, the markedly different
characteristics analysis should be applied to the entire product. Where the claim is to a nature-
based product produced by combining multiple components, the markedly different
characteristics analysis should be applied to the resultant nature-based combination, rather than
its component parts. Where the claim is to a nature-based product in combination with non-
nature based elements, the markedly different characteristics analysis should be applied only to
the nature-based product limitation. For a product-by-process claims, the analysis turns on whether the nature-based product in the claim has markedly different characteristics from its
naturally occurring counterpart.
The markedly different characteristics analysis compares the nature-based product limitation to
its naturally occurring counterpart in its natural state. Markedly different characteristics can be
expressed as the product’s structure, function, and/or other properties, and are evaluated based
on what is recited in the claim on a case-by-case basis. If the analysis indicates that a nature-
based product limitation does not exhibit markedly different characteristics, then that limitation is
a product of nature exception. If the analysis indicates that a nature-based product limitation
does have markedly different characteristics, then that limitation is not a product of nature
exception. Because the markedly different characteristics analysis compares the nature-based
product limitation to its naturally occurring counterpart in its natural state, the first step in the
analysis is to select the appropriate counterpart(s) to the nature-based product. When there are
multiple counterparts to the nature-based product, the comparison should be made to the
closest naturally occurring counterpart. When the nature-based product is a combination
produced from multiple components, the closest counterpart may be the individual nature-based
components of the combination. Because there is no counterpart mixture in nature, the closest
counterparts to the claimed mixture are the individual components of the mixture, i.e., each
naturally occurring species by itself. See, e.g., Funk Bros., 333 U.S. at 130, 76 USPQ at 281
(comparing claimed mixture of bacterial species to each species as it occurs in nature).
Markedly changed characteristics can include structural, functional, chemical changes.
In order to show a marked difference, a characteristic must be changed as compared to nature,
and cannot be an inherent or innate characteristic of the naturally occurring counterpart or an
incidental change in a characteristic of the naturally occurring counterpart. Myriad, 133 S. Ct. at
2111, 106 USPQ2d at 1974-75. Thus, in order to be markedly different, applicant must have
caused the claimed product to possess at least one characteristic that is different from that of
the counterpart. If there is no change in any characteristic, the claimed product lacks markedly
different characteristics, and is a product of nature exception.
Step 1: Determine if the claims are directed to one of the four statutory categories of patentable
subject matter identified by 35 U.S.C. 101: a process, machine, manufacture or composition of matter.
YES, the claims are directed to a composition of matter, which is a statutory category within at least one of the four categories of patent eligible subject matter.
Step 2A: PRONG ONE: Evaluate whether the claim recites a Judicial Exception (e.g., law of nature, natural phenomenon, or an abstract idea; see MPEP 2106.04). YES, the claims are product claims reciting something that appears to be a nature-based product (i.e., a drug formulation comprising one or more cannabinols selected from cannabidiol, cannabigerol, cannabichromene, a-terpinene, bisabolol, and camphene, wherein cannabigerol I present, and further comprising alpha-bisabolol) which is not markedly different from the closest naturally-occurring counterpart (i.e., the individual nature-based products).
Because the claim states the nature-based products which are plant extracts the markedly different characteristics is performed by comparing the nature-based product limitation to its natural counterpart.
The claim recites the naturally occurring components found within cannabis plants (instant claims 1, 3, and 16). This equates to a plant extract. The process of creating a plant extract is by partitioning the starting plant material into separate compositions based upon some property. The closest naturally occurring counterparts of extracted components are those same components when found existing in the plant in an unseparated form, even when purified and/or concentrated because they are chemically identical to the extracted compounds/components. All of these are naturally occurring in nature and are not markedly different from its naturally occurring counterpart in its natural state. The properties of the nature-based product as claimed are not markedly different than the properties of these naturally occurring counterparts found in nature as these activities would inherently be found in the plant they come from. The components which would give the activities claimed in the instant invention would inherently do the same in nature as there has been nothing done in the instant invention that would make them act in any different way.
Step 2A: prong two evaluates whether the claim as a whole integrates the recited judicial exception into a practical application (see MPEP 2106.04(d)). This evaluation is performed by (a)
identifying whether there are any additional recited elements in the claim beyond the judicial exception
and (b) evaluating those additional elements individually and in combination to determine whether the
claim as a whole integrates the exception into a practical application.
This judicial exception is not integrated into a practical application because the plant extract
composition is only comprising the nature-based components. The claims do not integrate the judicial
exceptions into a practical application because in this context, such integration for a claimed product
would be a physical form of the specific practical application instead of a more general composition that
is not so limited.
The claims do not include additional elements that are sufficient to amount to significantly more
than the judicial exception because these components and their activity are already found naturally
occurring in nature and the addition of an intended use does not impart any added benefit to the
compounds or integrate the composition into a practical application.
Step 2B evaluates whether the claim as a whole, amounts to significantly more than the recited
exception, i.e., whether any additional element, or combination of additional elements, adds an
inventive concept to the claim (see MPEP § 2106.05(b)).
The claims as a whole do not amount to more than the recited exceptions because there aren’t
any other additional elements to consider, which does not add an inventive concept to the claims. Thus,
the claims are not eligible subject matter under current 35 U.S.C. 101 standards.
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.
Claims 1, 3, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Alugupalli (WO 2020163775 A1).
Claim 1 recites “A pharmaceutical drug formulation for administration to a patient in need thereof, comprising one or more cannabinols selected from the group consisting of: (a) cannabidiol and the pharmaceutically acceptable salts, esters, solvates, optical isomers, and geometric isomers thereof, present in a molar concentration of from 0.03M to 3.0M; (b) cannabigerol and the pharmaceutically acceptable salts, esters, solvates, optical isomers, and geometric isomers thereof, present in a molar concentration of from 0.006M to 0.6M; and (c) cannabichromene and the pharmaceutically acceptable salts, esters, solvates, optical isomers, and geometric isomers thereof, present in a molar concentration of from 0.006M to 0.6M;and further comprising one or more terpenes selected from the group consisting of: (d) a-terpinene and the pharmaceutically acceptable salts, esters, solvates, optical isomers, and geometric isomers thereof, present in a molar concentration of from 0.022M to 2.2M; (e) bisabolol and the pharmaceutically acceptable salts, esters, solvates, optical isomers, and geometric isomers thereof, present in a molar concentration of from 0.021M to 2.1M; and (f) camphene and the pharmaceutically acceptable salts, esters, solvates, optical isomers, and geometric isomers thereof, present in a molar concentration of from 0.022M to 2.2M”. Claim 3 recites “The pharmaceutical formulation as claimed in claim 1, wherein cannabigerol is present in a molar concentration of 0.06M”. Claim 16 recites “The formulation as claimed in claim 1, further comprising one or more terpenes selected from the group comprising alpha-pinene, beta-pinene, camphene, beta-myrcene, D- limonene, 1,8-cineol, alpha-terpinene, gamma-terpinene, cis-beta-terpineol, terpinolene, linalool, fenchol, borneol, alpha-terpineol, alpha-cubebene, ylangene, alpha-copaene, beta-caryophyllene, alpha- bergamotene, alpha-humulene, alloaromadendrene, alpha-amorphene, (-)-lepidozene, beta- selinene, beta-cadinene, alpha-selinene, beta-dihydroagarofuran, alpha-bisabolol, beta-bisabolene, valencene, epizonarene, the selina-dienes, (-)-caryophyliene oxide, guaiol, 8-epi-gammaeudesmol, gamma- eudesmal, agarospiral, alpha-eudesimol, alpha-gurjunene, beta-eudesmaol, alpha-eudesmol, bulnesol, (-)-anymol, delta3-carene, alpha-ocimene, beta-ocimene, trans-alpha-bergamotene, and juniper camphor”.
Alugupalli recites a pharmaceutical composition comprising a-terpinene and a-bisabolol (understood by the examiner as alpha-terpinene and alpha-bisabolol): “A pharmaceutical composition comprising a nanoemulsion comprising one or more phytocannabinoid isolate(s) and at least four terpene isolates selected from limonene, myrcene, linalool, alpha-pinene, humulene, caryophyllene, b-caryophyllene, beta-pinene, a- phellandrene, A3-carene, a-terpinene, b-phellandrene, cis-ocimene, terpinolene, a-guaiene, 5- guaiene, elemene, guaiol, g-eudesmol, b-eudesmol, agarospirol, bulnesol, and a-bisabolol”(claim 1, emphasis made by the examiner; instant claims 1 and 16) . Alugupalli further recites the same composition comprising cannabigerol: “The composition according to claim 1 or 2, wherein the phytocannabinoid isolate(s) are selected from cannabidiol, cannabidiphorol, tetrahydrocannabiphorol, cannabidiolic acid, tetrahydrocannabinol, tetrahydrocannabinolic acid, cannabigerol, cannabinol, cannabichromene, tetrahydrocannabivarin, and cannabidivarin, and found at a concentration in the range of 0.5 to 2000 mg/ml and has a purity equal to or greater than 90%” (claim 3, emphasis made by the examiner; instant claims 1 and 3). The concentration range recited by Alugupalli for cannabigerol, 0.5-2000 mg/ml, is equivalent to 0.002-6 M, where the molar mass used for cannabigerol is 316.5 g/mol. This concentration range of cannabigerol encompasses the cannabigerol concentration range of 0.006 M to 0.6 M (instant claim 1) and the cannabigerol concentration of 0.06 M (instant claim 3).
Although Alugupalli does not explicitly recite a concentration of alpha-terpinene of 0.022 M to 2.2 M, as recited in instant claim 1, this concentration range is obvious over routine optimization. One of skill in the art could use an analytical balance for mass measurements and volumetric glassware for volume measurements to adjust the concentrations of the chemical components of the instantly claimed composition, including alpha-terpinene. Compositions comprising different concentrations of alpha-terpinene could be administered to different patients to achieve a pharmaceutical effect. The extent of the pharmaceutical effect in each patient could be measured through the reported frequency of pathological symptoms per unit time, or through measuring chemical compounds of interest in the blood or urine of the patient using HPLC, depending on the disease or condition of the patient.
Alugupalli is relied upon for the reasons discussed above. If not expressly taught thereby, based upon the overall beneficial teachings provided by the reference with respect to providing the composition, the adjustments of particular conventional working conditions (e.g., the selection from among known components and determining one or more suitable ranges (amounts, proportions, ratios thereof) in which to provide the pharmaceutical drug formulation), is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan.
From the teachings of Alugupalli, the invention as a whole, drawn to a pharmaceutical drug formulation as described in Claims 1, 3, and 16, would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, and one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention, as evidenced by the reference, especially in the absence of evidence to the contrary.
Please note, since the Office does not have the facilities for examining and comparing
Applicants’ composition with the composition of the prior art, the burden is on applicant to show
a novel or unobvious difference between the claimed product and the product of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald, 619 F.2d 67,
205 USPQ 594 (CCPA 1980), and “as a practical matter, the Patent Office is not equipped to
manufacture products by the myriad of processes put before it and then obtain prior art products
and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688
(CCPA 1972).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Robert F Spaine whose telephone number is (571)272-9099. The examiner can normally be reached 8:00 AM - 4:00 PM United States Eastern Time, Monday-Friday.
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, Anand Desai can be reached at (571) 272-0947. 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.
/R.F.S./Examiner, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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