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 1-5, 7, 8, 10, 13, 16, 18, 19, and 21-23) in the reply filed on May 12th, 2026 is acknowledged. The traversal is on the grounds that, according to the applicant, there is no undue burden to examine all of the claims in the application, noting that the Examiner in the international PCT application examined all of the claims as evidenced by the International Search Report/Written Opinion dated October 28, 2022. This is not found persuasive because as argued in the unity of invention requirement, the shared technical feature between claim groups I-III is not a special technical feature in view of the prior art. Claims 25, 27-29, and 32 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions, there being no allowable generic or linking claim.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 requirement in the reply filed on March 19th, 2026.
The requirement is still deemed proper and is therefore made FINAL.
Applicant's election with traverse of species A (Claim 2) and cannabidiol (CBD) (Claim 5) in the reply filed on May 12th, 2026 is acknowledged. The traversal is on the grounds that there is no undue burden to examine the features of the present claims, the noted species in each claim are related to a general inventive concept, and claim 5 recites alternative cannabis-derived compounds that share a common inventive concept and perform the same function within the claimed invention. The applicant recites that the examiner’s statements regarding members of the Markush group in claim 5 do not demonstrate distinctness or a serious search burden. This is not found persuasive because one of skill in the art would expect chemical compounds with different structures to have different affinities to enzymes and hormone receptors, and consequently non-equivalent biological effects, without evidence to the contrary. The applicant did not specifically point out the supposed shared function of alternative species. Furthermore, this election requirement is based on the lack of the same or corresponding technical features, not search burden. Claims 3 and 4 are withdrawn from further consideration, as being drawn to a nonelected species. Applicant timely traversed the election requirement in the reply filed on May 12th, 2026.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1, 2, 5, 7, 8, 10, 13, 16, 18, 19, and 21-23 are pending and were examined on the merits.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on January 17th, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
The information disclosure statement (IDS) submitted on November 26th, 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The use of the terms Vitashure, ICN, Amberlite, Purolite, Carbopol, Lipoid, Tween, Solutol, Cremophor, Myrj, Span, Brij, WS-3, FIBREX, EMDEX, GENU, ZYTEX, MALTISORB, DENTIZYME, FKM, Littleford Day, Ploughshare, Discus Dental, CP Kelco, JRS, and Roquette; each of which is a trade name or a mark used in commerce, has been noted in this application. Each term should be accompanied by the generic terminology; furthermore, each 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.
Claim Objections
Claim 2 is objected to because of the following informalities: the phrase "and or" should be changed to "and/or". Appropriate correction is suggested.
Claim objected to because of the following informalities: for clarity, a comma . Appropriate correction is suggested.
Claim 5 is objected to because of the following informalities: for clarity, the phrase ". Appropriate correction is suggested.
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.
Claims 1, 5, 7, 8, 10, 13, 16, 18, 19, and 21-23 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.
In claim 1, it is unclear if the first and second active agents are intended to be one or more constituent, derivative or extract of cannabis. The composition comprises those enumerated items, but the claim does not recite the first or second active agent is required to be those items. Clarification is requested.
The term “about” in claims 7 and 13 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The weight percent of the constituent, derivative, or extract of cannabis (claim 7); and the weight percent of surfactant (claim 13); are rendered indefinite by the use of the term "about".
Claim 13 contains the trademark/trade name Tween, Solutol HS15, Cremophor, Myrj, Span, Brij, and Nonoxynol. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe polyoxyethylene sorbitan fatty acid esters, polyoxyethylene 15 hydroxy stearate, polyoxyethylene castor oil derivatives, polyoxyethylene stearates, sorbitan fatty acid esters, polyoxyethylene alkyl ethers, and polyoxyethylene nonylphenol ethers, respectively, and, accordingly, the identification/description is indefinite. Furthermore, it is unclear if the scope of those chemicals are limited to the parenthetical components or something else. Suggest identifying chemicals being claimed without parenthetical presentations.
Claims dependent on a rejected claim are rejected for failing to cure the indefiniteness.
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.
Applicant assistance is requested in reviewing possible species that could be encompassed in a double patenting rejection based on the arguments presented currently.
Claims 1, 2, 5, 7, 8, 10, 13, 16, 18, 19, and 21-23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 7-9, 11, 14, 17, 19, 20, 22, and 23, of copending Application No. 18/580022 (reference application, document US-20240316076-A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because of the overlapping subject matter recited below.
Instant independent claim 1 and instant dependent claim 2, and reference independent claim 1, recite a composition comprising one or more constituent, derivative or extract of cannabis, where an active agent formulated for gastric delivery encompasses certain cannabis constituents, derivatives or extracts, and the composition comprises a different active agent formulated for buccal delivery. The flavor or sensate formulated for buccal delivery recited in reference claim 1 is not patentably distinct from the first active agent recited in instant claim 1 because a flavor or sensate is active in that it produces physiological effects related to the sense of taste. Instant claim 4, though not elected by the applicant, would also be rejected under double patenting over reference claim 1.
Instant claim 5 and reference claim 2 both recite a composition as claimed in claim 1, wherein the constituent, derivative or extract of cannabis is one or more compounds selected from a group encompassing cannabinoids; terpenes; alkaloids; and flavonoids.
Instant claim 5 and reference claim 3 both further recite a composition as claimed in claim 1, wherein the constituent derivative or extract of cannabis is selected from a group encompassing cannabidiol (CBD). The following non-elected species of instant claim 5 would also be rejected under double patenting over reference claim 3: cannabigerol (CBG), cannabichromene (CBC), tetrahydrocannabinol (THC), cannabinol (CBN), cannabinodiol (CBDL), cannabicyclol (CBL), cannabivarin (CBV), tetrahydrocannabivarin (THCV), cannabidivarin (CBDV), cannabichromevarin (CBCV), cannabigerovarin (CBGV), cannabigerol monomethyl ether (CBGM), cannabinerolic acid, cannabidiolic acid (CBDA), cannabinol propyl variant (CBNV), cannabitriol (CBO), tetrahydrocannabmolic acid (THCA), and tetrahydrocannabivarinic acid (THCV A).
Instant claim 7 and reference claim 4 both recite a composition as claimed in claim 2 wherein the constituent, derivative or extract of cannabis is present in an amount of from about 0.1 to about 30% by weight, based on the total weight of the composition.
Instant claim 8 and reference claim 9 both recite a composition as claimed in claim 1 comprising a means for solubilizing the one or more constituent, derivative or extract in an aqueous environment, optionally wherein the means for solubilizing the one or more constituent, derivative or extract in an aqueous environment comprising a solvent in which the one or more constituent, derivative or extract is at least partially dissolved.
Instant claim 10 and reference claim 11 recite a composition as claimed in claim 8 (instant claims) or claim 9 (reference claims), wherein the means for solubilizing the one or more constituent, derivative or extract in an aqueous environment encapsulates the one or more constituent, derivative or extract, optionally wherein the encapsulation is by a molecular encapsulant, such as a cyclodextrin, or wherein the encapsulation is by a micelle comprising a surfactant.
Instant claim 13 and reference claim 14 recite a composition as claimed claim 1, comprising a surfactant, optionally wherein the surfactant is selected from the group consisting of: glyceryl monooleate; and sodium lauryl sulfate (sodium dodecyl sulfate, SLS, or SDS), docusate sodium, lecithins, polyoxyethylene sorbitan fatty acid esters (Polysorbate, Tween®), polyoxyethylene 15 hydroxy stearate (Macrogol 15 hydroxy stearate, Solutol HS 15®), polyoxyethylene castor oil derivatives (Cremophor® EL, ELP, RH 40), polyoxyethylene stearates (Myrj®), sorbitan fatty acid esters (Span®), polyoxyethylene alkyl ethers (Brij®), polyoxyethylene nonylphenol ether (Nonoxynol®) and sugar esters, optionally wherein the surfactant is selected from the group consisting of long chain triglycerides (such as C16-C18 triglycerides), and further optionally wherein the composition comprises surfactant (or specifically, the surfactant in instant claim 13) in an amount of from about 0.5 to about 10% by weight, based on the total weight of the composition.
Instant claim 16 and reference claim 17 both recite a composition as claimed in claim 1, comprising an additive which slows or inhibits crystallization of the one or more constituent, derivative or extract of cannabis in an aqueous environment, optionally wherein the additive is selected from the group consisting of polyvinylpyrrolidone (PVP), hydroxypropyl cellulose (HPC) and mixtures thereof.
Instant claim 18 and reference claim 19 both recite a composition as claimed in claim 1,comprising one of more components enhancing enterocyte intestinal absorption of the one or more constituent, derivative or extract of cannabis.
Instant claim 19 and reference claim 20 both recite a composition as claimed in claim 1, comprising one of more components increasing intestinal lymphatic transport of the one or more constituent, derivative or extract of cannabis, optionally comprising a terpene, a grapefruit extract or a black pepper extract.
Instant claim 21 and reference claims 1, 5, 7-9, and 11 recite a composition as claimed in claim 1 comprising a flavor or sensate, where reference claim 8 specifically recites a sensate but not a flavor.
Instant claim 22 and reference claim 22 both recite a composition as claimed in claim 1 comprising a buffering agent.
Instant claim 23 and reference claim 23 both recite a composition as claimed in claim 1, in the form of a solid unit dosage form, a powder or granules, optionally in the form of particles having a volume mean diameter of 100 to 2000 μm.
Claims 1, 2, 5, 8, 10, 13, 21, and 23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 11, 13, 18, 20, and 22 of copending Application No. 18/580066 (primary reference application, document US-20240251841-A1) in view of copending application No. 18/580411 (secondary reference application, document US-20240415913-A1).
Although the claims at issue are not identical, they are not patentably distinct from the claims of the primary reference in view of the secondary reference because of the overlapping subject matter recited below.
Instant claims 1, 8, and 10; and primary reference claim 1; recite a composition comprising one or more constituent, derivative or extract of cannabis in solubilized form; the composition comprising one or more constituent, derivative or extract of cannabis recited in instant claim 1 and the solubilized for implied by the means for solubilizing recited in instant claims 8 and 10. Although instant claims 1, 8, and 10 do not explicitly recite a carrier material as primary reference claim 1 does, the solvent in which the extract of cannabis is solubilized could reasonably be considered a carrier material for the cannabis extract. Such carrier materials are supported by the instant specification as an emulsion system (page 15 lines 34-36 and page 16 lines 1-10).
Instant claims 1 and 2 (and the non-elected species of instant claim 3), and primary reference claim 22 recite a product for buccal delivery of one or more constituent, derivative or extract of cannabis. Although the claims of the primary reference do not explicitly recite formulation for gastric delivery of an active agent (instant claim 1), specifically one or more constituent, derivative, or extract of cannabis (instant claim 2 and non-elected species instant claim 4), secondary reference claims 1, 11-13, 25, and 26 imply gastric delivery of a composition comprising one or more constituent, derivative or extract of cannabis. It would be obvious to one of skill in the art to combine an active agent formulated for buccal delivery with an active agent formulated for gastric delivery because each formulation performs the same function as they do separately: delivery of the active agent into the bloodstream of the subject, and one of ordinary skill in the art would have recognized that the results of this combination were predictable: the delivery of both active agents into the bloodstream of the subject.
Instant claim 5 and primary reference claim 4 both recite a constituent, derivative or extract of cannabis as one or more compounds selected from a group encompassing at least cannabidiol (CBD); and the non-elected species of cannabinoids; terpenes; alkaloids; flavonoids or cannabigerol (CBG), cannabichromene (CBC), tetrahydrocannabinol (THC), cannabinol (CBN), cannabinodiol (CBDL), cannabicyclol (CBL), cannabivarin (CBV), tetrahydrocannabivarin (THCV), cannabidivarin (CBDV), cannabichromevarin (CBCV), cannabigerovarin (CBGV), cannabigerol monomethyl ether (CBGM), cannabinerolic acid, cannabidiolic acid (CBDA), cannabinol propyl variant (CBNV), cannabitriol (CBO), tetrahydrocannabmolic acid (THCA), and tetrahydrocannabivarinic acid (THCV A).
Instant claims 10 and 13 and primary reference claims 11 and 13 both recite a composition as claimed in independent claim 1, comprising a surfactant (instant claim 10 and primary reference claim 11), where the surfactant is selected from the group consisting of at least glyceryl monooleate; and sodium lauryl sulfate (sodium dodecyl sulfate, SLS, or SDS), docusate sodium, lecithins, polyoxyethylene sorbitan fatty acid esters (Polysorbate, Tween®), polyoxyethylene 15 hydroxy stearate (Macrogol 15 hydroxy stearate, Solutol HS 15®), polyoxyethylene castor oil derivatives (Cremophor® EL, ELP, RH 40), polyoxyethylene stearates (Myrj®), sorbitan fatty acid esters (Span®), polyoxyethylene alkyl ethers (Brij®), polyoxyethylene nonylphenol ether (Nonoxynol®), and sugar esters (instant claim 13 and primary reference claim 13).
Instant claim 21 and primary reference claim 18 recite a composition as claimed in independent claim 1, comprising a flavor or sensate.
Instant claim 23 and primary reference claim 20 recite a composition as claimed in independent claim 1, in the form of a solid unit dosage form, a powder or granules.
The same argument presented above for combining limitations from the primary and secondary references also applies claims 1, 13-15, 27, and 28 of copending application No. 18/579786 (US 20240335415 A1) as an alternative secondary reference to that cited above. Alternative primary references that could be used in the same argument for buccal delivery of an active agent, specifically, one or more constituent, derivative or extract of cannabis, include copending application numbers 18/580361 (document US 20250089757 A1, see claim 26), 18/579797 (document US 20240324652 A1, see claim 32), and 18/579985 (US 20240325414 A1, see claim 20).
This is a provisional nonstatutory double patenting rejection.
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, 2, 5, and 7 are rejected under 35 U.S.C. 101 because the claimed invention is directed to product of nature without significantly more. The claims recite a composition comprising one or more constituent, derivative or extract of cannabis and a further physiologically active agent selected from the group of nutraceuticals, nootropics and psychoactives. This judicial exception is not integrated into a practical application because combining the constituents as claimed does not add a meaningful limitation that differentiates the instantly claimed composition from its naturally occurring source materials. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims do not recite characteristics of the composition that markedly differentiate it from the naturally occurring source materials of its constituents.
The first step of the eligibility analysis evaluates whether the claim falls within a statutory category (see MPEP 2106.03). Since claims 1, 2, 5, and 7 are directed to a composition, 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 composition comprising a one or more constituent , derivative, or extract of cannabis and a further physiologically active agent (claims 1, 5, and 7); where the active agents recited in claim 1 are independently selected from the group consisting of constituents, derivatives or extracts of cannabis, nicotine, caffeine, taurine, theine, vitamins such as B6 or B12 or C, melatonin, gamma-aminobutyric acid (GABA), theanine, a botanical or combinations thereof (claim 2)) 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 organismal 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 (instants claim 1, 2, 5, and 7) and/or other organisms (the compounds recited in claim 2). This equates to an organismal extract. The process of creating an organismal extract is by partitioning the starting biological 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 organism 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 organism 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 organismal 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.
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, 2, 5, 7, 8, 10, 13, 16, 21, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Holzer et al. (US 20210038560 A1), abbreviated "Holzer".
Claim 1 recites “A composition comprising a first active agent formulated for buccal delivery and a second active agent formulated for gastric delivery, the composition comprising one or more constituent, derivative or extract of cannabis and a further physiologically active agent selected from the group consisting of nutraceuticals, nootropics and psychoactives”. Claim 2 recites “A composition as claimed in claim 1, wherein the first active agent, second active agent and or further physiologically active agent are independently selected from the group consisting of constituents, derivatives or extracts of cannabis, nicotine, caffeine, taurine, theine, vitamins such as B6 or B12 or C, melatonin, gamma-aminobutyric acid (GABA), theanine, a botanical or combinations thereof”. Claim 5 recites “A composition as claimed in claim 1, wherein the constituent, derivative or extract of cannabis is one or more compounds selected from: cannabinoids; terpenes; alkaloids; and flavonoids or is selected from the group consisting of: cannabigerol (CBG), cannabichromene (CBC), cannabidiol (CBD), tetrahydrocannabinol (THC), cannabinol (CBN), cannabinodiol (CBDL), cannabicyclol (CBL), cannabivarin (CBV), tetrahydrocannabivarin (THCV), cannabidivarin (CBDV), cannabichromevarin (CBCV), cannabigerovarin (CBGV), cannabigerol monomethyl ether (CBGM), cannabinerolic acid, cannabidiolic acid (CBDA), cannabinol propyl variant (CBNV), cannabitriol (CBO), tetrahydrocannabmolic acid (THCA), and tetrahydrocannabivarinic acid (THCV A)”. Claim 7 recites “A composition as claimed in claim 1 wherein the constituent, derivative or extract of cannabis is present in an amount of from about 0.1 to about 30% by weight, based on the total weight of the composition”. Claim 8 recites “A composition as claimed in claim 1,comprising a means for solubilizing the one or more constituent, derivative or extract in an aqueous environment, optionally wherein the means for solubilizing the one or more constituent, derivative or extract in an aqueous environment comprising a solvent in which the one or more constituent, derivative or extract is at least partially dissolved”. Claim 10 recites “A composition as claimed in claim 8 or claim 9, wherein the means for solubilising solubilizing the one or more constituent, derivative or extract in an aqueous environment encapsulates the one or more constituent, derivative or extract, optionally wherein the encapsulation is by a molecular encapsulant, such as a cyclodextrin, or wherein the encapsulation is by a micelle comprising a surfactant”. Claim 13 recites “A composition as claimed in claim 1, comprising a surfactant, optionally wherein the surfactant is selected from the group consisting of: glyceryl monooleate; and sodium lauryl sulfate (sodium dodecyl sulfate, SLS, or SDS), docusate sodium, lecithins, polyoxyethylene sorbitan fatty acid esters (Polysorbate, Tween®), polyoxyethylene 15 hydroxy stearate (Macrogol 15 hydroxy stearate, Solutol HS 15®), polyoxyethylene castor oil derivatives (Cremophor® EL, ELP, RH 40), polyoxyethylene stearates (Myrj®), sorbitan fatty acid esters (Span®), polyoxyethylene alkyl ethers (Brij®), polyoxyethylene nonylphenol ether (Nonoxynol®) and sugar esters, optionally wherein the surfactant is selected from the group consisting of long chain triglycerides (such as C16-C18 triglycerides),and further optionally wherein the composition comprises the surfactant in an amount of from about 0.5 to about 10% by weight, based on the total weight of the composition”. Claim 16 recites “A composition as claimed in claim 1,comprising an additive which slows or inhibits crystallization of the one or more constituent, derivative or extract of cannabis in an aqueous environment, optionally wherein the additive is selected from the group consisting of polyvinylpyrrolidone (PVP), hydroxypropyl cellulose (HPC) and mixtures thereof”. Claim 21 recites “A composition as claimed in claim 1, comprising a flavor or sensate”. Claim 23 recites “A composition as claimed in claim 1,in the form of a solid unit dosage form, a powder or granules, optionally wherein the composition is in the form of particles having a volume mean diameter of 100 to 2000 μm”.
Holzer recites the field of their invention “The disclosure provides consumable compositions comprising cannabinoids and one or more active ingredients and/or excipients and methods of producing the compositions” (paragraph [0002]; instant claims 1, 2, and 5).
Holzer recites routes of delivery of their disclosed composition “The compositions of the disclosure can be delivered through oral, sublingual, pulmonary, buccal, dermal, topical, or transdermal administration routes. The compositions can be administered through eating, swallowing, dissolving in the mouth, drinking, inhalation, smoking, topical applications. Forms can include: chocolate, capsule, tablet, ODT, pill, gummy (pectin or gelatin), soft chew, beverage, tincture, mint, lozenge, pastille, lollipop, chewing gum, effervescent tablet, powder, or liquid” (paragraph [0070]; instant claims 1 and 23), where eating, drinking, and swallowing, are broadly known in the art as routes of gastric delivery of a composition (instant claim 1). Although Holzer does not explicitly recite one active agent formulated for buccal delivery and another active agent formulated for gastric delivery, one of skill in the art would recognize that each of these two active agents combined perform the same function as they do separately, as there is no claimed synergistic effect from combining them. Moreover, one of skill in the art would have recognized that the result of combining these active agents is predictable; one active agent would be delivered into the bloodstream of a subject through a buccal route and the other through a gastric route, resulting in the biological effects known in the art for that particular agent (no particular agent is recited in claim 1, only broad classes of agents). Therefore, the combination of an active agent formulated for buccal delivery and an active agent formulated for gastric delivery would be obvious to one of skill in the art (instant claim 1).
Holzer further recites “The compositions of the disclosure can contain a variety of active ingredients that are suitable for consumption, including, but not limited to cannabinoids (e.g., THC and CBD), L-theanine, theobromine, Sceletium tortuosum, dihydrohonokiol (magnolia bark extract), corydalis (L-tetrahydropalmatine), theobromine, herbal extracts (e.g., muira puama, catuaba, damiana, ashwaghanda, and flower pollen), alpinia galanga, caffeine, rhodiola, bacopa, melatonin, passion flower, valerian root, 5-Hydroxytryptophan (5-htp), gamma-aminobutyric acid (GABA), chaste berry, cramp bark/black hawk, magnesium glycinate, potassium chloride, vitamin B6, and yohimbe” (paragraph [0042]; instant claims 1, 2, and 5), where the cannabinoids THC and CBD are constituents of Cannabis sativa (Holzer, paragraph [0003]; instant claims 1, 2, and 5). THC is responsible for psychoactive effects associated with cannabis consumption (Holzer, paragraph [0003]; instant claim 1). Holzer recites CBD as “non-psychoactive” (paragraph [0003]) but recites CBD as having been reported to possess anti-anxiety, anti-inflammatory, anti-psychotic, anticonvulsant, neuroprotective antioxidant, and antibiotic properties (paragraph [0004]; instant claims 1 and 2).
Holzer further recites delivery vehicles for their composition “In some embodiments of the disclosure, the composition is contained in a delivery vehicle to improve the solubility, bioavailability and onset time of the composition, wherein the delivery vehicle is a liposome, nanoparticle, complexation agent, cosolvency agent, a micelle, a nanocapsule, or a microcapsule” (paragraph [0025]; instant claims 8 and 10). Although Holzer does not explicitly recite increasing solubility of one or more constituent, derivative, or extract of cannabis in an aqueous environment, one of skill in the art would have been motivated to increase aqueous solubility for the gastric delivery of hydrophobic cannabis constituents such as THC and CBD in a beverage form (instant claims 1 and 2), and would have had a reasonable expectation of success at increasing their aqueous solubility through micellar encapsulation of hydrophobic molecules using an amphiphilic surfactant (instant claims 8 and 10). Therefore, the motivation of delivering hydrophobic cannabis constituents such as THC and CBD in a beverage form, as recited above, would also provide motivation to include an amphiphilic surfactant such as sodium dodecyl sulfate (SDS) in the instantly claimed composition (instant claim 13). One of skill in the art would have had a reasonable expectation of success at adding an amphiphilic surfactant such as sodium dodecyl sulfate (SDS) to the instantly claimed composition by combining the surfactant with other composition components and mixing (instant claim 13). The motivation of delivering hydrophobic cannabis constituents such as THC and CBD in a beverage form, as recited above, would also provide motivation to include an additive in the composition which slows or inhibits crystallization of the one or more constituent, derivative, or extract of cannabis (instant claim 16). One of skill in the art would have a reasonable expectation of success at slowing or inhibiting crystallization of the one or more constituent, derivative, or extract of cannabis through micellular encapsulation by adding a surfactant such as SDS (instant claim 16). The micellar encapsulation of the molecules comprising the one or more constituent, derivative, or extract of cannabis would slow or inhibit the crystallization of these molecules by limiting the scale of the aggregation of these molecules (instant claim 16).
Holzer further recites the inclusion of a flavoring agent in their composition: “[0027] In some embodiments of the disclosure, the composition is low in sugar or sugar free. [0028] In other embodiments of the disclosure, the composition further comprises a natural flavoring agent, an artificial flavoring agent, a bitter masker, a natural colorant, an artificial colorant, a binder, an emulsifier, a disintegrant, a sweetener, or a preservative” (paragraphs [0027] and [0028]; instant claim 21).
The instant claims are distinguished from Holzer in that Holzer does not explicitly recite a composition wherein the constituent, derivative, or extract of cannabis is present in an amount of from about 0.1% to about 30% by weight, based on the total weight of composition (instant claim 7). However, the weight percents of wherein the constituent, derivative, or extract of cannabis is obvious to one of skill in the art over routine optimization. One of skill in the art could weigh the components of the composition using a scale instrument before combining them, and, therefore, control the weight percent of each component in the whole composition. One of skill in the art could administer compositions comprising different weight percents of a constituent, derivative, or extract of cannabis to a subject and optimize this weight percent based on the subject’s feedback describing it effects, such as (but not necessarily limited to) specific intoxication symptoms and/or specific changes in emotional state, compared with the intended effect(s) of administering the composition (instant claim 7).
Holzer 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 comprising one of more constituent, derivative, or extract of cannabis, 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 composition, 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 Holzer, the invention as a whole, drawn to a composition comprising one or more constituent, derivative, or extract of cannabis as described in Claims 1, 2, 5, 7, 8, 10, 13, 16, 21, and 23, 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).
Claims 1, 2, 5, 7, 8, 10, 13, 16, 18, 19, 21, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Holzer et al. (US 20210038560 A1), abbreviated "Holzer", as applied to claims 1, 2, 5, 7, 8, 10, 13, 16, 21, and 23 above, and further in view of Izgelov et al. (European Journal of Pharmaceutical Sciences 2020, 148, 105313), abbreviated "Izgelov"; and Franco et al. (Clinical Pharmacokinetics 2020, 59, 1493-1500), abbreviated "Franco".
The claims and the cited references of previous grounds of rejection under 35 U.S.C. 103 are of record above.
Claim 18 recites “A composition as claimed in claim 1, comprising one of more components enhancing enterocyte intestinal absorption of the one or more constituent, derivative or extract of cannabis”. Claim 19 recites “A composition as claimed in claim 1, comprising one of more components increasing intestinal lymphatic transport of the one or more constituent, derivative or extract of cannabis, optionally comprising a terpene, a grapefruit extract or a black pepper extract”.
The instant claims are distinguished from Holzer in that Holzer does not explicitly recite one of more components enhancing enterocyte intestinal absorption of the one or more constituent, derivative or extract of cannabis and one of more components increasing intestinal lymphatic transport of the one or more constituent, derivative or extract of cannabis.
One of skill in the art would have been motivated to enhance enterocyte intestinal absorption and increase intestinal lymphatic transport of the one or more constituent, derivative or extract of cannabis to minimize the effective waste of the one or more constituent, derivative or extract of cannabis through non-absorption into the bloodstream and/or lymphatic system of the subject whereby it would be distributed through the body.
One of skill in the art would have had a reasonable expectation of success at enhancing the enterocyte intestinal absorption of the cannabis constituent CBD by adding (an) amphiphilic surfactant(s) such as lecithin to solubilize CBD through encapsulation in lipospheres (Izgelov, Introduction paragraph 6, subheading 2.2 SNEDDS and piperine-SNEDDS preparation, Discussion paragraphs 3-5; instant claims 8, 10, 13, 16, and 18).
One of skill in the art would have had a reasonable expectation of success at increasing intestinal lymphatic transport of the cannabis constituent CBD, given the teachings of Franco. Regarding the transfer of lipophilic drugs to the lymphatic system, Franco recites: “The transfer of orally administered, highly lipid-soluble drugs to the lymphatic system is mediated by their association with chylomicrons, large intestinal lipoproteins that are assembled in the enterocytes in the presence of long-chain triglycerides or long-chain fatty acids” (Franco, Abstract; instant claims 18 and 19). Therefore, increasing intestinal lymphatic transport of one or more constituent, derivative, or extract of cannabis implies increasing intestinal enterocyte absorption; and one of skill in the art would have a reasonable expectation of success at increasing intestinal lymphatic transport of lipid soluble drugs through the addition of long-chain triglycerides or long-chain fatty acids (as further supported by Franco, Introduction paragraph 2 and heading 5 Potential Strategies to Facilitate Lymphatic Absorption paragraph 5; instant claims 18 and 19). One of skill in the art would have had a reasonable expectation of success at applying this strategy, of increasing intestinal lymphatic transport, to the cannabis constituent CBD because of the lipophilicity of CBD (Franco, Abstract; instant claims 18 and 19).
Therefore, it would have been obvious to one of skill in the art, before the effective filing date of the claimed invention, to make a composition comprising one of more components enhancing enterocyte intestinal absorption of the one or more constituent, derivative or extract of cannabis (instant claim 18) and comprising one of more components increasing intestinal lymphatic transport of the one or more constituent, derivative or extract of cannabis (instant claim 19).
Claims 1, 2, 5, 7, 8, 10, 13, 16, and 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over Holzer et al. (US 20210038560 A1), abbreviated "Holzer", as applied to claims 1, 2, 5, 7, 8, 10, 13, 16, 21, and 23 above, and further in view of Holton et al. (US 20210169789 A1), abbreviated "Holton".
The claims and the cited references of previous grounds of rejection under 35 U.S.C. 103 are of record above.
Claim 22 recites “A composition as claimed in claim 1, comprising a buffering agent”.
The instant claims are distinguished from Holzer in that Holzer does not explicitly recite the inclusion of a buffering agent.
Holton recites the field of their disclosure “The present disclosure relates to flavored products intended for human use. The products are configured for oral use and deliver substances such as flavors and/or active ingredients during use. Such products may include tobacco or a product derived from tobacco, or may be tobacco-free alternatives” (paragraph [0001]). Holton further specifies non-limiting examples of active ingredients, including cannabis; vitamins B6, B12, and C, and cannabinoids such as tetrahydrocannabinol (THC) and cannabidiol (CBD) (paragraph [0080]). Holton further recites the inclusion of buffering agents in their disclosed compositions (paragraph [0119]). Therefore, Holton at least provides suggestion of a composition comprising a constituent of cannabis (such as THC or CBD) and a buffering agent (instant claim 22). One of skill in the art would have also been motivated to use a buffering agent to control and standardize the pH of the composition, to avoid the possibility of unintended chemical reactions from occurring in the composition (instant claim 22). One of skill in the art would have had a reasonable expectation of success at adding a buffering agent to the instantly claimed composition by adding a chemical compound from the following: alkali metals acetates, glycinates, phosphates, glycerophosphates, citrates, carbonates, hydrogen carbonates, borates, or mixtures thereof (Holton, paragraph [0119]; instant claim 22). Therefore, it would be obvious to one of skill in the art to add a buffering agent to the composition recited by Holzer (instant claim 22).
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.
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/R.F.S./Examiner, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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