DETAILED ACTION
Summary
This is a non-final office action for application 17/922,564. The response to the restriction/election requirement dated 28 October 2025 is acknowledged.
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 1-2, 4, 6 and 10-17 in the reply filed on 28 October 2025 is acknowledged. The traversal is on the grounds that the three inventive groups have unity of invention under 37 CFR 1.475(b) as they represent a product (group III, Claims 30-31), a process specially adapted for the manufacture of said product (Group II, Claims 19-21 and 23-25) and an apparatus or means specifically designed for carrying out said process (Group I, Claims 1-2, 4, 6 and 10-17). In response, the process (Group II) cannot be specially designed for the manufacture of the product (Group III) because Group III does not require any element of Group II. Also, the means (Group I) is not specifically designed for this process because it can be used in other extraction protocols that differ from the Claims recited in Group II, such as the extraction protocol taught by MARCHIONI (cited in the previous office action). Therefore, unity of invention is determined by PCT Rule 13.2( see MPEP 1850-I) where the shared technical features between the inventive groups are examined to determine if they are special technical features. The shared technical features are determined not to be special technical features as they do not make a contribution over the prior art of MARCHIONI (Analytica Chimica Acta 1099 (2020), 145-154) for the reasons set forth in the previous office action:
Groups I-II lack unity of invention because even though the inventions of these groups require the technical feature of an imprinted polymer, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of MARCHIONI (Analytica Chimica Acta 1099 (2020), 145-154; Available Online 16 November 2019; included in the IDS dated 21 June 2023). MARCHIONI teaches molecularly imprinted polymers (Section 1, par 7) based on hydrogenated CBD (Section 1, last paragraph). Hydrogenated CBD (Fig. 3 (a)) has a hydroxyphenyl group and has a molecular weight of 318 g/mol).
Groups II-III lack unity of invention because even though the inventions of these groups require the technical feature of enriched cannabinoid, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of MARCHIONI (Analytica Chimica Acta 1099 (2020), 145-154). MARCHIONI teaches chromatograms showing a peak in CBD concentration (Fig. 5(b)). The composition at the time underneath the peak represents an enriched CBD composition.
Groups I-III do not appear to share a common technical feature besides the enriched cannabinoid referenced in the intended use clause of Claim 1. To the extent that this is a common technical feature, it is not a special technical feature as it does not make a contribution over the prior art in view of MARCHIONI (Analytica Chimica Acta 1099 (2020), 145-154). MARCHIONI teaches chromatograms showing a peak in CBD concentration (Fig. 5(b)). The composition at the time underneath the peak represents an enriched CBD composition.
The requirement is still deemed proper and is therefore made FINAL.
Claims 19-21, 23-25 and 30-31 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 28 October 2025.
Claim Objections
Claims 4, 6, 10 and 15 are objected to because of the following informalities:
In Claim 4, in section a), please replace “acryls” with “acryl”.
In Claim 6, please replace “tert-butylacryamide (TBA)” with “tert-butylacrylamide (TBA)”.
In Claim 10, please replace the “or or” that spans lines 10-11 of the claim with “or”
In Claim 15, please replace “Cannabidiol (CBD)” with “cannabidiol (CBD)” as the name for this molecule is not a proper noun.
Appropriate correction is required.
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.
Claim 2 and 10-13 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.
Claim 2 recites in a-iii). “a vinyl monomer selected from a styryl or vinylpyridine”. The term “styryl” is not a noun representing a monomer, but an adjective describing a type of monomer. It is not clear what structure is being claimed here. If the intent is to recite a styryl monomer, please recite “a styryl monomer”.
Regarding Claims 10-13, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance,
Claim 10 recites the broad recitation of R1 and R2 together forming a 5- or 6-membered ring, and the claim also recites “preferably” a 6-membered ring which is the narrower statement of the range/limitation.
Claim 11 recites the broad recitation of one or more of the R groups is a saturated alkyl group and the claim also recites “preferably” a saturated alkyl group with 2 to 8 carbons which is the narrower statement of the range/limitation.
Claim 12 recites the broad recitation at least one of R2, R3, and R5 is an alkyl and the claim also recites “preferably” a 4-6 alkyl which is the narrower statement of the range/limitation.
Claim 13 recites the broad recitation wherein Rx is alkyl, cycloalkyl or aryl, and the claim also recites “preferably” a aryl which is the narrower statement of the range/limitation.
The claims are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 11 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 11 recites that one or more of R1, R2, R3, R4 or R5 is a saturated alkyl group. Claim 11 depends upon, and therefore includes Claim 1. Claim 10 recites that R1 is H or forms a ring with the attachment at the R2 or R5 positions, which excludes the existence of a saturated alkyl group at the R1 position. Claim 11 does not contain all the limitations of Claim 10 from which it depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2 and 14 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by KALIVRETENOS (WO-2020186077-A1).
The KALIVRETENOS (WO-2020186077-A1) reference is in the IDS dated 21 June 2023 and is prior art under 102(a)(2) due to its PCT filing date of 12 March 2020.
Regarding Claim 1, KALIVRETENOS teaches molecularly imprinted polymers (MIP) for extraction of cannabinoids (Title, Abstract). KALIVRETENOS teaches that its molecularly imprinted polymers are templated by a surrogate molecule ([0090]). KALIVRETENOS teaches that its surrogate molecule is a cannabinoid surrogate which allows the other monomers to self-assemble or coordinate to it. KALIVRETENOS teaches that its template cannabinoid surrogate can be a cannabinoid surrogate containing monomer ([0086]) or a non-monomeric cannabinoid surrogate ([0087]). KALIVRETENOS exemplifies t-THC-03 ([00106], [00229], Fig. 3) for its non-monomeric surrogate template and CBD-mono ([00104], [00201], Fig. 1)
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which have molecular weights of 304.43 g/mol and 444.61 g/mol, respectively which are within the 150-450 g/mol recited by the claim. In the structures above, note that both t-THC-03 and CBD-mono contain hydroxyl groups on a benzene ring which satisfies the requirement of a hydroxyphenyl group. KALIVRETENOS teaches that its molecularly imprinted polymers are used for the efficient viable purification processes for cannabinoids from crude cannabis extracts ([0073]) which satisfies the intended use clause of the claim.
Regarding Claim 2, KALIVRETENOS teaches the invention of Claim 1. KALIVRETENOS generally teaches that its polymer is formed from a non-crosslinking monomer and a crosslinking monomer ([0086], [0087]) and teaches many non-crosslinking monomers that are acryl or vinyl monomers ([00124]) and many crosslinking monomers that are either vinyl or acryl ([00121]) which satisfy the a-i) option of the claim. KALIVRETENOS exemplifies styrene and divinyl benzene (DVB) for these two monomers ([0201], Fig. 1) which are vinyl monomers which satisfy the b) requirement of the claim.
Regarding Claim 14, KALIVRETENOS teaches that its surrogate template is a cannabinoid. ([0087]) and teaches and exemplifies cannabinoid surrogates ([00106]).
Claims 1-2, 4 and 16-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CELA-PEREZ (Journal of Chromatography A, 1429 (2016) 53–64).
The CELA-PEREZ (Journal of Chromatography A, 1429 (2016) 53–64) reference is in the IDS dated 21 June 2023.
Regarding Claim 1, CELA-PEREZ teaches a molecularly imprinted solid phase extraction methodology (Abstract) for detection of detection of cannabinoids such as THC, THC-COOH, CBN and CBD (Abstract). CELA-PEREZ further teaches a molecularly imprinted polymer MIP formed using polymerizable monomers (Abstract, Fig. 1-B) and catechin as a mimic-template (Abstract). CELA-PEREZ teaches the structure of catechin (CATE) (Fig 1-A):
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which has a molecular weight of 290.27 which is within the 150-450 g/mol range recited by the claim and has four OH groups attached to benzene rings which satisfies the requirement of a structure comprising a hydroxyphenyl group.
The recitation that the imprinted polymer is for producing an enriched cannabinoid extract from a crude cannabis extract is an intended use. Case law holds that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See In re Casey, 152 USPQ 235 (CCPA 1967) and In re Otto, 136 USPQ 458, 459 (CCPA 1963). CELA-PEREZ teaches that its imprinted polymer selectively adsorbs cannabinoids from urine or oral fluid which can be later desorbed and tested (Sect. 2.9). It is interpreted that following desorption, the cannabinoid is enriched in its solvent as it would no longer contain other compounds that did not adsorb to the imprinted polymer. It is presumed that an imprinted polymer which selectively adsorbs cannabinoids would be suitable for the intended use of producing an enriched cannabinoid extract from a crude cannabis extract.
Regarding Claim 2, CELA-PEREZ teaches that invention of Claim 1 where CELA-PEREZ functional monomers which include 4-vinylpyridine, methacrylic acid, 2-hydroxyethyl methacrylate and acrylamide (Fig. 1-B) and exemplifies acrylamide and ethylene glycol dimethacrylate (Section 3.2). These are all vinyl or acryl monomers and satisfy option a-i) as is recited by the claim. The use of ‘or’ in the claim languages makes the other options optional.
Regarding Claim 4, CELA-PEREZ teaches the invention of Claim 1. CELA-PEREZ teaches acryl monomers such as acrylamide (AM) and ethylene glycol dimethacrylate (EGDMA) for creation of its molecularly imprinted polymer (Abstract). CELA-PEREZ exemplifies AM and EDGMA monomers to create it molecularly imprinted polymer (Section 3.2, line 1). This satisfies a) as recited by the claim.
Regarding Claims 16-17, CELA-PEREZ teaches the invention of Claim 1, where CELA-PEREZ teaches using catechin as a template (Abstract) which is acknowledged by the applicant to be a flavan-3-ol as the Claim 17 limitation that the template is catechin depends upon, and therefore includes, Claim 16 which requires that the template is a flavan-3-ol. So, CELA-PEREZ teaching a catechin template satisfies both Claim 16 and Claim 17.
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 4, 6, 10-13 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over KALIVRETENOS (WO-2020186077-A1).
Regarding Claim 4, KALIVRETENOS teaches the invention of Claim 1 above. KALIVRETENOS teaches that its molecularly imprinted polymer is formed from a non-crosslinking monomer and a crosslinking monomer ([0086], [0087]). KALIVRETENOS teaches many acryl monomers for its non-crosslinking monomer including many alkyl (meth)acrylates and substituted (meth)acrylamides ([0124]). KALIVRETENOS also teaches many acryl monomers for its crosslinking monomer including ethylene glycol methacrylate (EGDMA) and other polyalkylene glycol di(meth)acrylates, and vinyl or allyl (meth)acrylates ([00121]). KALIVRETENOS does not exemplify an acryl monomer for either component but it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the current invention to modify the examples of KALIVRETENOS and use an acryl monomer for its non-crosslinking monomer and/or its crosslinking monomer based on the teachings of the specification.
Regarding Claim 6, KALIVRETENOS teaches the invention of Claim 1 above. KALIVRETENOS teaches that its molecularly imprinted polymer is formed from a non-crosslinking monomer and a crosslinking monomer ([0086], [0087]). KALIVRETENOS teaches many specific monomer for its non-crosslinking monomer, including t-butylacrylamide ([0124]). KALIVRETENOS teaches many specific monomers for its crosslinking monomer, including ethylene glycol dimethacrylate (EGDMA)([0121]). KALIVRETENOS does not exemplify this combination, but it would be obvious to one of ordinary skill in the art at the time of the effective filing date of the current invention to modify the examples of KALIVRETENOS and use t-butylacrylamide as its non-crosslinking monomer and ethylene glycol dimethacrylate (EGDMA) as its crosslinking monomer based on the teachings of the specification.
Regarding Claim 10, KALIVRETENOS teaches the invention of Claim 1 above. KALIVRETENOS teaches that in some embodiments, its cannabinoid template has the following structure ([0092]):
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this largely overlaps the structure recited by the claim, where both -O- attachments can be OH or linker, R2 and R4 are H, the R5 between the -O- is H, organic group, or linker, and R3 can be an organic group which can be a hydrophobic moiety. KALIVRETENOS teaches several specific cannabinoid surrogates including olivetol, and several 2-substituted olivetols ([0091]). KALIVRETENOS does not teach the structure of olivetol. Here, the specification of the current invention is used as evidence to show the structure of olivetol (cur spec: [0072]):
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This satisfies the structure recited by the claim where R1=R2=R4=R5=H and R3=pentyl. KALIVRETENOS does not exemplify using olivetol as its cannabinoid surrogate, but it would be obvious to one of ordinary skill in the art at the time of the effective filing date of the current invention to modify the examples and use olivetol as its cannabinoid surrogate based on the teachings of the specification.
Regarding Claim 11, modified KALIVRETENOS teaches the invention of Claim 10 where KALIVRETENOS teaches the use of olivetol as a cannabinoid surrogate (template) which satisfies the structure of Claim 10 where R1=R2=R4=R5=H and R3=pentyl, where pentyl is a saturated alkyl group which satisfies the claim. Also note that the pentyl group has 5 carbon atoms.
Regarding Claim 12, modified KALIVRETENOS teaches the invention of Claim 10 where KALIVRETENOS teaches the use of olivetol as a cannabinoid surrogate (template) which satisfies the structure of Claim 10 where R1=R2=R4=R5=H and R3=pentyl, where pentyl is an alkyl group which satisfies the claim. Also note that the pentyl group has 5 carbon atoms.
Regarding Claim 13, modified KALIVRETENOS teaches the invention of Claim 10 where KALIVRETENOS teaches the use of olivetol as a cannabinoid surrogate (template) which satisfies the structure of Claim 10 where R1=R2=R4=R5=H and R3=pentyl. These R-groups also satisfy the narrower recitations for R1, R2, R3, R4, and R5 that are recited by Claim 13.
Regarding Claim 15, modified KALIVRETENOS teaches the invention of Claim 14. KALIVRETENOS teaches that its target molecule is a specific component of a cannabis extract, such as THC or cannabidiol (CBD) ([0074]). KALIVRETENOS teaches using CBD as a target molecule ([00220]). While KALIVRETENOS teaches uses a cannabinoid surrogate having substantially the same steric and functional properties of the target cannabinoid instead of the target molecule itself, KALIVRETENOS teaches that using the target molecule itself as the template is the conventional process and provides improved selectivity ([0080]) and that surrogate cannabinoids are used for their lower cost. KALIVRETENOS exemplifies using CBD-derived monomers such as CBD-mono ([00201], Fig. 1) and CBD-bis ([00209]) as the surrogate (template) but does not specifically use CBD itself as the template. But it would be obvious to one of ordinary skill in the art at the time of the effective filing date of the current invention to modify the invention KALIVRETENOS and use CBD itself as the template molecule for its molecularly imprinted polymer for the purpose of obtaining improved selectivity.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID R FOSS whose telephone number is (571)272-4821. The examiner can normally be reached Monday - Friday 8:00 - 5:00.
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/D.R.F./Examiner, Art Unit 1764
/KREGG T BROOKS/Primary Examiner, Art Unit 1764