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 .
Claim Objections
Claim 8 is objected to because of the following informalities: Claim 8 sets forth a copolymer having a plurality of complexing cavities but only sets forth removal of the cannabinoid surrogate to provide “a” complexing cavity (singular). For consistency, it is suggested that Claim 8 be amended to either set forth a single complexing cavity in the preamble or otherwise amend the claim such that multiple cannabinoid surrogates are removed to provide a plurality of complexing cavities.
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.
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 8 – 12, 17 – 19, 21, 22, and 69 are rejected under 35 U.S.C. 103 as being unpatentable over US 9,504,988 to Gluckman et al. (hereinafter Gluckman) in view of US 2003/0003587 to Murray, as evidenced by US 2019/0224142 to Vu et al. (hereinafter Vu).
Regarding Claims 8, 11, 12, 17 – 19, and 21. Gluckman teaches molecularly imprinted polymer (MIP) beads which are macroreticular (Column 6, Lines 12 – 20). The MIP materials disclosed by Gluckman comprise complexing cavities which selectively bind a target molecule (Column 15, Lines 9 – 15).
The polymer may be prepared by a suspension polymerization process in which a polymerizable ligand/surrogate complex monomer, styrene, and divinylbenzene are provided in the polymerizable organic phase (Column 8, Lines 5 – 12). Styrene is set forth as a non-crosslinking monomer in instant Claims 19 and 21, while divinylbenzene is set forth as a crosslinking monomer in instant Claims 17 and 18. Following polymerization, the surrogate may be removed from the beads (Column 9, Lines 6 – 8).
Gluckman teaches selecting surrogates having the same size, shape, and physicochemical characteristics as target molecules, wherein suitable target molecules include drug molecules (Column 4, Line 50 – Column 5, Line 6).
Gluckman does not expressly set forth the surrogate-containing monomer is a cannabinoid surrogate-containing monomer for a target drug molecule which is specifically ∆-9-tetrahydrocannabinol (THC). However, Murray teaches the concept of preparing MIPs using surrogate molecules for narcotic target compounds. The surrogate molecules in Murray may specifically be compounds in which the narcotic molecule is covalently bound to a polymerizable monomer and, after polymerization, the covalent bond is cleaved to release the narcotic compound from the polymeric mold. Cannabinoids are expressly described as suitable narcotic target compounds ([0051] and [0058]). It is the Office’s position that THC would be readily envisioned from Murray’s disclosure of cannabinoids by a person of ordinary skill in the art, as Vu provides evidence that THC is one of two the major cannabinoids in the cannabis plant [0007]. Gluckman and Murray are analogous art as they are from the same field of endeavor, namely MIPs targeting drug molecules. Before the effective filing date of the instantly claimed invention, it would have been obvious to a person of ordinary skill in the art to provide a surrogate-containing monomer for a cannabinoid, such as THC, in Gluckman for the purposes of targeting such a compound. The motivation would have been that doing so would allow for the MIPs of Gluckman to be used in the detection of an illicit drug, specifically cannabis (Murray: [0003] and [0005]).
Regarding Claims 9, 10, and 69. Gluckman in view of Murray teaches the plurality of macroreticular beads of Claim 1. It is the Office’s position that it would have been obvious to select THC as the target molecule for the reasons detailed in the rejection of Claim 1 above.
The applied references do not expressly teach the structure of the cannabinoid surrogate-containing monomer. However, the structure of the cannabinoid surrogate-containing monomer would appear to constitute a product-by-process limitation that is not further limiting in as so far as the structure of the product is concerned. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695,698, 227 USPQ 964, 966 (Fed. Cir. 1985) (MPEP 2113) Once a product appearing substantially identical is found, the burden shifts to the applicant to show an unobvious difference between the claimed product and the prior art product. In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir. 1993) (MPEP 2113)
In the instant case, the claimed plurality of macroreticular polymer beads do not comprise the cannabinoid surrogate-containing monomer, as Claim 1 requires at least the cannabinoid surrogate portion thereof be removed. The product suggested by the combination of Gluckman with Murray, in which the cannabinoid surrogate is also removed and in which the target molecule is also THC, then appears to be substantially identical to the instantly claimed product.
Regarding Claim 22. Gluckman teaches the plurality of macroreticular beads of Claim 1 have a surface area of 0.1 to 500 m2/g (Column 6, Lines 51 – 52).
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 8 – 12, 17 – 19, 21, 22, and 69 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1 – 7 and 11– 24 of copending Application No. 17/438,343 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they are obvious variations upon each other.
The instant claims differ from the claims of Application No. 17/438,343 in that they set forth the copolymer is prepared by a method comprising admixing monomers (a) – (c). However, it is the Office’s position that it would have been readily envisioned by a person of ordinary skill in the art from the claims of Application No. 17/438,343 to admix monomers (a) – (c), as a copolymer of these monomers could not be formed without such a process step.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments filed September 18, 2025 have been fully considered. The Office responds as follows:
Claim Objections
Regarding the outstanding claim objection to Claim 8, applicant argues that that the surrogate molecule is removed to create a particular complexing cavity, while the copolymer comprises a plurality of such complexing cavities. The Office has maintained the claim objection as the claim only provides for the creation a single particular complexing cavity via the introduction of “a” single cannabinoid surrogate, whereas the ultimate product contains a plurality of complexing cavities.
All other claim objections have been withdrawn in light of the amendments to the instant claims.
Claim Rejections – 35 U.S.C. 112
The Office agrees the amendments to the claims are sufficient to overcome all outstanding rejections under 35 U.S.C. 112. Accordingly, all rejections under 35 U.S.C. 112 have been withdrawn.
Claim Rejections – 35 U.S.C. 103
The Office has established a prima face case of obviousness
In assessing whether a claim to a combination of prior art elements or steps would have been obvious, the question to be asked is whether the improvement of the claim is more than the predictable use of prior art elements or steps according to their established functions. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007). “[T]he analysis need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” Id. at 418.
Applicant argues that the Office has not established a prima facie case at least because the cited references do not teach or suggest all claim elements, including the use of a cannabinoid surrogate-containing monomer. However, these arguments do not adequately consider the prior art as a whole and the inferences one of ordinary skill would have drawn therefrom.
Primary reference Gluckman teaches the concept of preparing molecularly imprinted polymer (MIP) beads in which a polymerizable ligand/surrogate complex monomer is provided and, following polymerization, are removed from the beads. Gluckman further teaches selecting surrogates having the same size, shape, and physicochemical characteristics as target molecules, wherein suitable target molecules include drug molecules (Column 4, Line 50 – Column 5, Line 6). Thus, primary reference Gluckman itself teaches the concept of providing surrogate-containing monomers which target drug molecules.
The Office recognizes that Gluckman does not expressly teach cannabinoids as a species of drug molecule which can be targeted. However, when a single prior art reference which discloses a genus encompassing the claimed species or subgenus but does not expressly disclose the particular claimed species or subgenus, Office personnel should attempt to find additional prior art to show that the differences between the prior art primary reference and the claimed invention as a whole would have been obvious. (MPEP 2144.08) The outstanding rejection thus applies secondary reference Murray, which teaches cannabinoids as suitable species of the genus of target drug molecules for MIPs. In light of Murray, it is the Office’s position that it would have been obvious to a person of ordinary skill in the art to provide a surrogate-containing monomer for a cannabinoid in Gluckman for the purposes of targeting such a compound. The Office consequently maintains the position that the instantly claimed products would be reasonably expected to be substantially identical to the molecularly imprinted polymer beads arising from the combination of Gluckman with Murray.
Regarding applicant’s argument that the narcotic template in Murray is identical to the target narcotic molecule, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. The test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). It is respectfully submitted that the outstanding rejection suggested it would have been obvious to a surrogate-containing monomer for a cannabinoid in Gluckman. The outstanding rejection did not suggest providing the template of Murray to manufacture of the MIPs of Gluckman.
Double Patenting
Applicant argues that the claims of U.S. Application No. 17/438,343 set forth a cannabinoid surrogate-containing monomer, as opposed to a cannabinoid surrogate as instantly claimed. However, both the cannabinoid surrogate-containing monomer set forth in the claims of U.S. Application No. 17/438,343 and the instantly claimed cannabinoid surrogate having the same properties, namely they are both required to have substantially the same steric and functional properties as the target cannabinoid and they are removed to provide a complexing cavity that selectively binds a target cannabinoid. Moreover, a cannabinoid surrogate-containing monomer is also reasonably considered to a species of the cannabinoid surrogate genus. It has been held that the generic invention is "anticipated" by the "species". See In Re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since the instant claims are “anticipated” by the claims of U.S. Application No. 17/438,343, they are not patentably distinct from these claims.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELISSA RIOJA whose telephone number is (571)270-3305. The examiner can normally be reached Monday - Friday 10:00 am - 6:30 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Arrie Lanee Reuther can be reached at (571)270-7026. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MELISSA A RIOJA/Primary Examiner, Art Unit 1764