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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 26 May 2026 has been entered.
Priority
The instant application was filed on 09 March 2022 and claims domestic benefit to provisional application no. 63/158,400 filed on 09 March 2021. Therefore, the effective filing date of the instant application is 09 March 2021.
Examiner’s Note
Applicant's amendments and arguments filed 26 May 2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Rejections not reiterated from previous office actions are hereby withdrawn. The following rejections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. In the Applicant’s response, filed 26 May 2026, it is noted that claims 1 and 17 have been amended, no claims have been newly canceled, and no new claims have been added. Support for the amendment can be found from the existing claims. 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, 3-10, 14, 15, 17-19 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.
Instant claims 1, 3-10, 14, 15, 17-19 describe a film dosage comprising a water-soluble or water swellable film-forming polymer matrix with a pharmaceutical active The Applicant’s specification does not provide evidence that the Applicant was in possession of the invention or how to perform the invention without undue experimentation. The Applicant does not specify or provide detailed examples or embodiments of the combination of ingredients that would result in the claimed pharmacokinetic profile.
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 8 and 17 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 8 recites “derivative, or analogue of epinephrine” and claim 17 recites “non-hormonal sterol derivative.” The Applicant’s specification does not define or specify the
derivatives or analogues for epinephrine or non-hormonal sterol 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).
Claim 17 recites “both systemic and non-systemic” in parenthesis. The parenthetical recitation renders the claim indefinite because it is unclear whether the limitations in the parenthesis are part of the claimed invention or describing an example of preference. See MPEP 2173.05(d).
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.
Claims 1, 3-10, 14, 15, 17-19, 35-37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schobel et al. (US 11541002 B2) and Abdelbary et al. (Pharmaceutical and Pharmacokinetic Evaluation of a Novel Fast Dissolving Film Formulation of Flupentixol Dihydrochloride, AAPS PharmSciTech, 2014).
Regarding claim 1, Schobel et al. teach an oral film in individual unit dose for delivery of any drug active agent (entire teaching; abs; col. 4, lns. 60-67) to the oral mucosa (col. 70, ln. 50). The oral film may comprise water-soluble and water swellable polymers such as polyethylene oxide, pullulan (claim 20), or HPMC (col. 47, ln. 27), water (col. 43, lns. 35-38) and “a range of disintegration times” (col. 70, lns. 58-63). The limitation of administering the dosage form to the oral mucosa of a mammal in claim 1 is interpreted as a product-by-process limitation and is given minimal patentable weight. See MPEP 2113(I).
Regarding claim 3, traditional dissolution methods, which is interpreted as a corresponding enterally delivered dosage form, are in the form of tablets and capsules (col. 73, ln. 4).
Regarding claims 7 and 8, the composition may comprise active agents, such as epinephrine (col. 23, ln. 49).
Regarding claims 9 and 10, the composition may further include a penetration enhancer (col. 54, ln. 10), such as phytoextract derivatives (col. 56, ln. 18).
Regarding claims 14 and 15, the water-soluble and water swellable polymers include polyethylene oxide or pullulan (claim 20).
Regarding claim 17, the active agents include anti-inflammatory agents, such as NSAIDs (col. 6, ln. 64).
Regarding claim 18, the active agents include testosterone (col. 15, ln. 23).
Regarding claim 19, the active agents include anti-inflammatory agents, such as NSAIDs (col. 6, ln. 64).
Regarding claim 35, Schobel et al. teach an oral film in individual unit dose for delivery of an active agent (entire teaching; abs) to the oral mucosa (col. 70, ln. 50). The oral film may comprise water-soluble and water swellable polymers such as polyethylene oxide or pullulan (claim 20), water (col. 43, lns. 35-38), and silicon dioxide (col. 49, ln. 4). The limitation of administering the dosage form to the oral mucosa of a mammal in claim 1 is interpreted as a product-by-process limitation and is given minimal patentable weight. See MPEP 2113(I).
Regarding claim 36, silicon dioxide may be used in an amount of 0.02-1% (col. 52, lns. 10-13).
Schobel et al. teach that the amounts of active agents in the film depends on the chosen active ingredient and may be in an amount from about 0.001 to 99% (col. 5, lns. 1-20).
Schobel et al. do not specifically teach that films comprise 0.5-40% less active than other enterally delivered formulations in claims 1 and 35. Schobel also does not specifically teach the pharmacokinetic profiles of the film dosage or setting amounts based on comparison with a close enteral delivered formulation in claims 4-6 and 37.
In regards to selecting a combination of polyethylene oxide, hormone, silicon dioxide, phytoextract derivatives, and NSAIDs, “[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
combinations 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.”
Schobel teaches an oral film in individual unit dose for delivery of an active agent to the oral mucosa, whereas the claimed invention is directed towards compositions comprising a film dosage form comprising a water-soluble or water swellable film-forming polymer matrix containing an active agent. Since Schobel 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.
In regards to the pharmacokinetic limitations in claims 1, 4-6, 35, and 37, the U.S. Patent Office is not equipped with analytical instruments to test prior art compositions for the infinite number of ways that a subsequent applicant may present previously unmeasured characteristics. When as here, the prior art appears to contain the exact same ingredients (any pharmaceutical active and any water-swellable polymer) and applicant's own disclosure supports the suitability of the prior art composition as the inventive composition component, the burden is properly shifted to applicant to show otherwise.
In regards to the pharmacokinetic (AUC and Cmax) limitations in claims 1 and 35, Abdelbary teaches an oral film comprising an active agent and a water-soluble polymer, such as HPMC (abs). The Cmax and AUC values for the films exceeded the tablets (Table IV). Since Schobel teaches an oral film comprising any active agent and water-swellable polymer, such as HPMC, a skilled artisan would have been led to Abdelbary’s findings on higher Cmax and AUC values for oral films (comprising a water-swellable polymer, such as HPMC and an active agent) than for oral tablets. “Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use (see MPEP § 2144.07).”
In regards to the limitation of containing 0.5-40% less active in claims 1 and 35, the adjustment of particular conventional working conditions (e.g., determining result effective amounts of the ingredients beneficially taught by the cited references, especially within the broad ranges instantly claimed), is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Accordingly, this type of modification would have been well within the purview of the skilled artisan and no more than an effort to optimize results.
Therefore, it would be obvious to adjust the amount of active to maintain or produce a more favorable composition for the intended purpose, e.g. for consumption or as a dietary supplement, food ingredient or additive, a medical food or a nutraceutical.
Claims 1, 3-10, 14, 15, 17-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schobel et al. (US 20180200198 A1) and Abdelbary et al. (Pharmaceutical and Pharmacokinetic Evaluation of a Novel Fast Dissolving Film Formulation of Flupentixol Dihydrochloride, AAPS PharmSciTech, 2014).
Regarding claim 1, the film composition and its components can be water-soluble, water swellable or water-insoluble (para. 126). Schobel et al. ‘198 teach oral films (entire teaching; para. 3) that may comprise active agents (para. 40), polyethylene oxide (para. 26) or HPMC (para. 27), and water (para. 127). The films provide desired disintegration rates (para. 138).
Regarding claim 3, The composition may be a chewable dosage form, tablet, or film (para. 38, 39).
Regarding claims 7 and 8, the active agent can be epinephrine (para. 22).
Regarding claims 9 and 10, the composition may include permeation enhancers (para. 46) and phytoextracts (paras. 9, 10).
Regarding claim 14, the oral films (entire teaching; para. 3) may comprise polyethylene oxide (para. 26).
Regarding claim 15, the polymer may include pullulan (para. 34).
Regarding claim 17, the active agent can be an anti-inflammatory agent (para. 121).
Regarding claim 18, the active component can be testosterone (para. 123).
Regarding claim 19, NSAID anti-inflammatory active agents include diclofenac, alclofenac, diclofenac sodium, ibuprofen, ketoprofen, naproxen, pranoprofen, fenoprofen (para. 123).
Schobel et al. do not specifically teach that films comprise 0.5-40% less active than other enterally delivered formulations in claim 1. Schobel also does not specifically teach the pharmacokinetic profiles of the film dosage or setting amounts based on comparison with a close enteral delivered formulation in claims 4-6.
In regards to selecting a combination of polyethylene oxide, phytoextract derivatives, and NSAIDs, “[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 combinations 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.”
Schobel et al. teach oral films that may comprise polyethylene oxide, hormones or testosterone, permeation enhancer, pharmaceutical active, PVP, xanthan gum, and phytoextracts, whereas the claimed invention is directed towards compositions comprising a film dosage form comprising a water-soluble or water swellable film-forming polymer matrix containing an active agent. Since Schobel 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.
In regards to the pharmacokinetic limitations in claims 1 and 4-6, the U.S. Patent Office is not equipped with analytical instruments to test prior art compositions for the infinite number of ways that a subsequent applicant may present previously unmeasured characteristics. When as here, the prior art appears to contain the exact same ingredients (any pharmaceutical active and any water-swellable polymer) and applicant's own disclosure supports the suitability of the prior art composition as the inventive composition component, the burden is properly shifted to applicant to show otherwise.
In regards to the pharmacokinetic (AUC and Cmax) limitations in claim 1, Abdelbary teaches an oral film comprising an active agent and a water-soluble polymer, such as HPMC (abs). The Cmax and AUC values for the films exceeded the tablets (Table IV). Since Schobel teaches an oral film comprising any active agent and water-swellable polymer, such as HPMC, a skilled artisan would have been led to Abdelbary’s findings on higher Cmax and AUC values for oral films (comprising a water-swellable polymer, such as HPMC and an active agent) than for oral tablets. “Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use (see MPEP § 2144.07).”
In regards to the limitation of containing 0.5-40% less active in claim 1, the adjustment of particular conventional working conditions (e.g., determining result effective amounts of the ingredients beneficially taught by the cited references, especially within the broad ranges instantly claimed), is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Accordingly, this type of modification would have been well within the purview of the skilled artisan and no more than an effort to optimize results.
Therefore, it would be obvious to adjust the amount of active to maintain or produce a more favorable composition for the intended purpose, e.g. for consumption or as a dietary supplement, food ingredient or additive, a medical food or a nutraceutical.
Response to Arguments
Applicant's arguments filed 26 May 2026 have been fully considered but they are not persuasive.
The Applicant argues that the Office Action “cherry-picks” from the teachings and that it would not have been obvious to a skilled artisan to select the combination of variables to arrive at the claimed invention (Remarks, pgs. 8-9).
Applicant’s argument is not found persuasive. The Applicant is reminded that the teachings of KSR are actually an endorsement and expansion of the flexible and expansive approach to obviousness, which clearly invites continued reliance on such broad and flexible analyses concerning the utility of selecting alternative embodiments of components providing art-recognized utility, with no substantial change in the overall utility of a composition so formulated. See KSR International Co. v. Teleflex, Inc., 82 USPQ2d 1385, 1395-96 (U.S.2007) (“the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results”; “When 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”; “a court must ask whether the improvement is more than the predictable use of prior art elements according to their established functions” exemplified by the holdings of cases such as Merck v. Biocraft.
The Applicant argues that Schobel ‘002 and Bala do not provide AUC and Cmax data and that a skilled artisan would not have been led to the pharmacokinetic properties of the claimed invention (Remarks, pgs. 9-11).
Applicant’s argument is not found persuasive. Bala has been removed as prior art and the arguments against them will not be addressed. Furthermore, in regards to the pharmacokinetic (AUC and Cmax) limitations in claims 1 and 35, Abdelbary teaches an oral film comprising an active agent and a water-soluble polymer, such as HPMC (abs). The Cmax and AUC values for the films exceeded the tablets (Table IV). Since Schobel teaches an oral film comprising any active agent and water-swellable polymer, such as HPMC, a skilled artisan would have been led to Abdelbary’s findings on higher Cmax and AUC values for oral films (comprising a water-swellable polymer, such as HPMC and an active agent) than for oral tablets. “Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use (see MPEP § 2144.07).”
The Applicant argues that hindsight reconstruction was used to reach the subject matter of the instant claims (Remarks, pg. 12).
Applicant’s argument is not found persuasive. Regarding hindsight reconstruction, “[a]ny judgment on obviousness is in a sense necessarily a reconstruction based on hindsight reasoning, but so long as it takes into account only knowledge which was within the level of ordinary skill in the art at the time the claimed invention was made and does not include knowledge gleaned only from applicant’s disclosure, such a reconstruction is proper.” In re McLaughlin, 443 F.2d 1392, 1395, 170 USPQ 209, 212 (CCPA 1971).
The Applicant argues that the Office Action “cherry-picks” from the teachings of Schobel ‘198 and Bala and that it would not have been obvious to a skilled artisan to select the combination of variables to arrive at the claimed invention (Remarks, pgs. 13-14).
Applicant’s argument is not found persuasive. The Applicant is reminded that the teachings of KSR are actually an endorsement and expansion of the flexible and expansive approach to obviousness, which clearly invites continued reliance on such broad and flexible analyses concerning the utility of selecting alternative embodiments of components providing art-recognized utility, with no substantial change in the overall utility of a composition so formulated. See KSR International Co. v. Teleflex, Inc., 82 USPQ2d 1385, 1395-96 (U.S.2007) (“the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results”; “When 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”; “a court must ask whether the improvement is more than the predictable use of prior art elements according to their established functions” exemplified by the holdings of cases such as Merck v. Biocraft.
The Applicant argues that Schobel ‘198, Yang, and Bala do not provide AUC and Cmax data and that a skilled artisan would not have been led to the pharmacokinetic properties of the claimed invention (Remarks, pgs. 14-16).
Applicant’s argument is not found persuasive. Yang and Bala have been removed as prior art and the arguments against them will not be addressed. Furthermore, in regards to the pharmacokinetic (AUC and Cmax) limitations in claim 1, Abdelbary teaches an oral film comprising an active agent and a water-soluble polymer, such as HPMC (abs). The Cmax and AUC values for the films exceeded the tablets (Table IV). Since Schobel teaches an oral film comprising any active agent and water-swellable polymer, such as HPMC, a skilled artisan would have been led to Abdelbary’s findings on higher Cmax and AUC values for oral films (comprising a water-swellable polymer, such as HPMC and an active agent) than for oral tablets. “Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use (see MPEP § 2144.07).”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Danielle Kim whose telephone number is (571)272-2035. The examiner can normally be reached M-F: 9-5 p.m. PST.
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/D.A.K./Examiner, Art Unit 1613
/ANDREW S ROSENTHAL/Primary Examiner, Art Unit 1613
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