DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 31 December 2025 has been entered.
Priority
The instant application was filed on 07 July 2021 and is the national stage entry of PCT/EP2020/050569 filed on 10 January 2020. The Applicant claims foreign priority to application no. DE10 2019 100483.7 filed on 10 January 2019. A translated copy of the foreign document has not been provided; therefore, the effective filing date of the application is 10 January 2020.
Examiner’s Note
Applicant's amendments and/or arguments filed 31 December 2025 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. In the Applicant’s response, filed 31 December 2025, it is noted that claim 1 has been amended, claim 2 has been canceled, and claims 42 and 43 have been newly added. Support for the amendment can be found on pg. 4 of the instant specification. No new matter has been added.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 5, and 38 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1 and 38 recite a derivative of vitamin E, and claim 5 recites starch derivatives and cellulose derivatives. The Applicant’s specification does not define or specify the
derivatives or analogues for vitamin E, starch, and derivatives, and, thus, may vary greatly in structure and/or function. The specification also does not provide for a sufficient representative number of species that would allow for all the types of derivatives or analogues that can exist for the listed compounds. MPEP 2163 II - A “representative number of species” means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014). In this case, the genus is “derivatives” of all structures of vitamin E, cellulose, and starch in claims 1, 5, and 38.
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, and 38 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.
Claims 1, 5, and 38 recite “derivatives” of vitamin E, starch, and cellulose. The metes and bounds of the limitation cannot be determined due to lack of written description for “derivatives.”
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.
Claim(s) 1, 3-6, 9, 10, 33, 37-43 is/are rejected under 35 U.S.C. 103 as being unpatentable over Elsohly et al. (WO 03101357 A1), Chistov (US 10058531 B1), Krekeler (WO 2016009001 A1), and healthline.com, as evidenced by qualifiedcontrols.com.
Elsohly et al. teach a single or multi-layered oral film (entire teaching; pg. 10, para. 2) that may comprise a reservoir or cavity for the matrix (claim 9) to delivery cannabinoids (title). In one example, the outer layer may include hydroxypropylcellulose in an amount of 37% and THC in an amount of 8% in the inner matrix (pg. 10, para. 3; Example 1). THC includes THC pro-drugs, metabolites, derivatives, or analogs (claim 8 and Table 1). The film can optionally include vitamin E as a surfactant (pg. 14, para. 2), which is interpreted similarly to an emulsifier and where no surfactant is required in the composition. To improve solubility for the cannabinoid, fatty acid triglycerides may be included (pg. 1, para. 1). PEG 400 is a solubilizer that may be used in an amount of 8% (Example 1). The composition thus far addressing claims 3-6, 9, 33, 40, and partially claim 41. The inner matrix comprises 50% of the entire composition in Example 1. Therefore, the inner hydrophobic phase is interpreted as roughly 50% of the entire film, addressing claim 10. Since the film may be made of multiple layers, which includes a reservoir for the matrix, it is interpreted as addressing a cavity with the layers enclosing the matrix in claim 37. Some of the formulations have greater than 96% of the active agent remaining after 12 months of storage (Table II, pg. 20-21). It is interpreted that the storage conditions are similar to standard conditions for cannabinoid products (60-70°F and 59-63% relative humidity; qualifiedcontrols.com, pg. 3), especially since the processes performed on the film can improve unstable THC products (pg. 19-21), addressing partially claim 1. The film layers may comprise a water-insoluble polymer with at least one cannabinoid (pg. 11, para. 3), where it is interpreted that the hydrophobic cannabinoid is contained in the inner portion of the films with the water-insoluble or hydrophobic polymer, addressing claims 1, 42, and 43.
Elsohly does not teach 5-20% of vitamin E in their composition or isopropyl myristate in claim 1.
Krekeler teaches that isopropyl myristate, a medium-chain triglyceride (entire teaching; specification, pg. 9), may be used as a plasticizer in orodispersible films to reduce the brittleness and increase flexibility (para. 43).
Healthline.com teaches that tocopheryl acetate is more stable compared to tocopherol in dietary supplements (entire teaching; pg. 4).
In regards to selecting a combination of THC, vitamin E, and hydroxypropyl cellulose in an oral film, “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G.Pro, 425 U.S. 273, 282 (1976)). “When the question is whether a patent claiming the combination of elements of prior art is obvious,” the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “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.” KSR at 1741. The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Consistent with this reasoning, it would have been obvious to have selected various
combination of various disclosed ingredients from within a prior art disclosure, to arrive at compositions “yielding no more than one would expect from such an arrangement.”
Since Elsohly teaches the individual components of the claimed composition, it is obvious for one of ordinary skill in the art to select the different combinations of ingredients to arrive at the claimed invention with a reasonable expectation of success.
Since Elsohly does not teach isopropyl myristate in their oral film composition in claim 1, one of ordinary skill in the art would have been motivated to look to Krekeler’s teaching of isopropyl myristate as a plasticizer to increase flexibility as Elsohly also teaches incorporating additives for matrix flexibility (pg. 11, para. 3).
Since Elsohly does not specifically teach tocopheryl acetate but does teach vitamin E in their oral film dosage in claims 39 and 41, one of ordinary skill in the art would have been motivated to use healthline.com’s teaching of using tocopheryl acetate because it is more stable in oral products than tocopherol.
In regards to the amounts of components in claims 1 and 38, Chistov teaches an oral film that comprises cannabinoid (abs; col. 1, lns. 5-15) such as 5-10% THC (claim 2; Table 5), a polymer such as hydroxyethyl cellulose or 5-50% polyvinyl alcohol (Example 9; col. 7, ln. 62-col. 8, ln. 31), a surfactant such as vitamin E (claim 3), and a lipophilic carrier (col. 9, lns. 23-30). The surfactant, which is interpreted similarly to emulsifier, may be in an amount of 1-25% (Table 6), where vitamin E is an option as a surfactant and no other surfactants are required. Elsohly teaches hydroxypropylcellulose in an amount of 37% and THC in an amount of 8% in the inner matrix (Example 1). That being said and in lieu of objective evidence of unexpected results, the amount can be viewed as a variable that achieves the recognized result of successfully making the oral film composition. The optimum or workable range of the concentration can be accordingly characterized as routine optimization and experimentation (see MPEP 2144.05 (II)B). “[Discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” In re Boesch, 617 F.2d 272, 276 (CCPA 1980). Applicants provide no evidence of any secondary consideration such as unexpected results that would render the optimized amounts of vitamin E as nonobvious.
Response to Arguments
Applicant's arguments filed 31 December 2025 have been fully considered but they are not persuasive.
The Applicant argues that the inner matrix in Elsohly’s Example 1 does not comprise any hydrophobic substance (Remarks, pg. 8).
Applicant’s argument is not found persuasive. The Applicant is erroneously pointing to narrow embodiments expressly disclosed within the prior art reference as representing the sum total of information conveyed by each. Art is art, not only for what it expressly teaches, but also for what it would reasonably suggest to the skilled artisan, including alternative or non-preferred embodiments (see MPEP § 2123). Furthermore, the film layers may comprise a water-insoluble polymer with at least one cannabinoid (pg. 11, para. 3), where it is interpreted that the hydrophobic cannabinoid is contained in the inner portion of the films with the water-insoluble or hydrophobic polymer, addressing claims 1, 42, and 43.
The Applicant argues that Elsohly does not disclose the subject matter of claims 9 and 10 and is predicated on an impermissible hindsight reconstruction of the claims (Remarks, pg. 8).
Applicant’s argument is not found persuasive. It must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
The Applicant argues that a person of ordinary skill in the art would not have been motivated to modify Elsohly’s teaching to move the THC from a hydrophilic phase to a hydrophobic phase (Remarks, pgs. 8-9).
Applicant’s argument is not found persuasive. Elsohly teaches that the film layers may comprise a water-insoluble polymer with at least one cannabinoid (pg. 11, para. 3), where it is interpreted that the hydrophobic cannabinoid is contained in the inner portion of the films with the water-insoluble or hydrophobic polymer.
The Applicant argues that Christov does not teach that the cannabinoids are present substantially in the inner hydrophobic phase (Remarks, pg. 9).
Applicant’s argument is not found persuasive. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Christov teaches cannabinoid micelles form the hydrophobic core portion of the formulation (col. 6, lns. 21-35). Additionally, Christov’s teaching is used to address the amounts of components that are not taught in Elsohly’s teaching.
The Applicant argues that Krekeler does not teach the features of amended claim 1 (Remarks, pg. 9).
Applicant’s argument is not found persuasive. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Krekeler teaches that isopropyl myristate, a medium-chain triglyceride (entire teaching; specification, pg. 9), may be used as a plasticizer in orodispersible films to reduce the brittleness and increase flexibility (para. 43). Therefore, a skilled artisan would have been motivated to use isopropyl myristate as a plasticizer in Elsohly’s film composition to improve brittleness.
The Applicant argues that qualifiedcontrols.com does not teach the standard conditions for storage of cannabinoid products (Remarks, pg. 9).
Applicant’s argument is not found persuasive. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Qualifiedcontrols.com is used as evidentiary evidence regarding the standard storage conditions for cannabis products to prevent degradation of the cannabinoids, which are interpreted as pharmaceutical products.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/D.A.K./Examiner, Art Unit 1613
/ANDREW S ROSENTHAL/Primary Examiner, Art Unit 1613