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 .
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/or arguments filed 02 December 2025 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 Rejections not reiterated from previous office actions are hereby withdrawn.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
02 December 2025, it is noted that claims 1, 4, and 35 have been amended 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 § 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 Bala et al. (Orally dissolving strips: A new approach to oral drug delivery system, Int. J. Pharm. Investig., 2013).
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), suitable active agents may be hormones (col. 5, ln. 55), such as testosterone (col. 15, ln. 23), penetration enhancers (col. 54, ln. 10), such as phytoextract derivatives (col. 56, ln. 18), silicon dioxide (col. 49, ln. 4), and NSAIDs (col. 6, ln. 64), addressing claims 7-10, 14, 15, 17-19, and 35. 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), which addresses claim 3. 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). Under the polymer section in the first two paragraphs, Schobel teaches combining the polymers with water to make the film formulation.
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).
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.
Bala et al. teach that tablet formulations can accommodate high doses of drug material (entire teaching; pg. 68). However, high doses cannot be incorporated into oral strips (pg. 69). Additionally, film formulations avoid degradation in the GI tract and first pass effect (abs). Therefore, less active agent is needed in the formulation compared to a tablet to achieve the same effect.
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
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.”
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 and 35, 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 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.
Furthermore, the limitation of the AUC and Cmax of the film dosage form having 80-125% of the amounts of actives compared to the enterally delivered dosage form at a confidence level of at least 80% in instant claims 1 and 35 is interpreted as a functional property of the composition. Since the properties cannot be separated from the composition and if the components are present, then the composition will necessarily have the effect, based on the broadest reasonable interpretation of a system claim having a structure that performs a function (see MPEP 2111.04 II).
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, 35-37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schobel et al. (US 20180200198 A1), Yang et al. (US 20190060172 A1), and Bala et al. (Orally dissolving strips: A new approach to oral drug delivery system, Int. J. Pharm. Investig., 2013).
Schobel et al. ‘198 teach oral films (entire teaching; para. 3) that may comprise polyethylene oxide (para. 26), hormones (para. 121) or testosterone (para. 123), permeation enhancer (para. 46), pharmaceutical active (para. 46), PVP (para. 135), xanthan gum (para. 135), and phytoextracts (para. 9, 10), addressing claims 7-10, 14, 15, and 18. Schobel provides different film formulations wherein the Tmax, Cmax, and AUC values may be at least 80% of the ODT Alprazolam formulations (para. 263, 267). Schobel teaches a wide variety of active agent doses in mg amounts (paragraph 124). The film composition and its components can be water-soluble, water swellable or water-insoluble (para. 126). NSAID anti-inflammatory active agents include diclofenac, alclofenac, diclofenac sodium, ibuprofen, ketoprofen, naproxen, pranoprofen, fenoprofen (para. 123), addressing claims 17 and 19. Other additives include anti-tacking, flow agents, and opacifiers (para. 150). The composition may be a chewable dosage form, tablet, or film (para. 38, 39), addressing claim 3.
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 does not teach silicon dioxide in their composition in claims 35 and 36. 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.
Yang teaches films with active components (abs). Yang teaches silicon dioxide in amounts of 0.02 to 1% as texturing agents (para. 159).
Bala et al. teach that tablet formulations can accommodate high doses of drug material (pg. 68). However, high doses cannot be incorporated into oral strips (pg. 69).
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 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.”
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 claims 35 and 36, one of ordinary skill in the art at the time of instant filing would have included the silicon dioxide in amounts of the examined claims by teachings of Yang which indicates that adding silicon dioxide as a texturing agent would be useful to the film formulation like that of Schobel ‘198.
In regards to the pharmacokinetic limitations in claims 1 and 35, 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 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.
Furthermore, the limitation of the AUC and Cmax of the film dosage form having 80-125% of the amounts of actives compared to the enterally delivered dosage form at a confidence level of at least 80% in instant claims 1 and 35 is interpreted as a functional property of the composition. Since the properties cannot be separated from the composition and if the components are present, then the composition will necessarily have the effect, based on the broadest reasonable interpretation of a system claim having a structure that performs a function (see MPEP 2111.04 II).
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.
Response to Arguments
Applicant's arguments filed 02 December 2025 have been fully considered but they are not persuasive.
The Applicant argues that Shcobel’s and Bala’s teachings are general and that there is no reason to use less active in a film to achieve the desired pharmacokinetic profile (Remarks, pgs. 9-10).
Applicant’s argument is not found persuasive. In regards to the pharmacokinetic limitations in claims 1 and 35, 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 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 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
Additionally, Clinical Pharmacokinetic Studies of Pharmaceuticals document (2001) states that clinical pharmacokinetic studies are performed to examine absorption, distribution, metabolism, and excretion of a drug and such data are useful for the design and conduct of subsequent clinical trials. The data are also necessary for appropriate analysis and evaluation of the efficacy and safety data obtained in the clinical trials (pg. 3, introduction). Therefore, the determination of pharmacokinetic properties in a new drug is well-known in the art and a person of ordinary skill in the art would have been compelled, with a reasonable expectation of success, to optimize in order to achieve the desired dosage which provides the most desirable pharmacokinetic profile, and, as such, would have arrived at the claimed invention.
The Applicant argues that Schobel and Bala are silent on measuring AUC and Cmax data and provide no guidance on it (Remarks, pgs. 10-11).
Applicant’s argument is not found persuasive. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Where a rejection of a claim is based on two or more references, a reply that is limited to what a subset of the applied references teaches or fails to teach, or that fails to address the combined teaching of the applied references may be considered to be an argument that attacks the reference(s) individually. Where an applicant’s reply establishes that each of the applied references fails to teach a limitation and addresses the combined teachings and/or suggestions of the applied prior art, the reply as a whole does not attack the references individually as the phrase is used in Keller and reliance on Keller would not be appropriate. This is because “[T]he test for obviousness is what the combined teachings of the references would have suggested to [a PHOSITA].” In re Mouttet, 686 F.3d 1322, 1333, 103 USPQ2d 1219, 1226 (Fed. Cir. 2012).
The Applicant argues that the prior art is not considered in its entirety and that the Examiner used two extreme points (Remarks, pgs. 11-12).
The teachings from Heller have been removed as prior art and the arguments against them will not be addressed.
The Applicant argues that Schobel teaches away from the claimed invention (Remarks, pgs. 14-15).
Applicant’s argument is not found persuasive. In response to the Applicant's argument that the references fail to show certain features of applicant’s invention, it is reminded that to properly teach away, the prior art reference must criticize, discredit, or otherwise discourage the solution sought. Merely teaching alternatives does not do this (see MPEP 2145 (X)(D)).
The Applicant argues that whether or not high doses in Bala’s teaching may be incorporated into oral strips is irrelevant (Remarks, pg. 15).
Applicant’s argument is not found persuasive. Bala teaches that high doses cannot be incorporated into oral strips (pg. 69) and that film formulations avoid degradation in the GI tract and first pass effect (abs). Therefore, if high doses of drugs cannot be used in oral strips or films, it is interpreted that less active agent would be used in the formulation compared to a tablet to achieve the same effect.
It is noted that “products of identical chemical composition cannot have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990) (see MPEP 2112.01 (II)).
The Applicant argues that there is nothing in Schobel or Bala to lead a skilled artisan to the pharmacokinetic profile of the claimed invention (Remarks, pg. 16).
Applicant’s argument is not found persuasive. 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 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.
The Applicant argues that the prior art is not considered in its entirety and that the Examiner used two extreme points (Remarks, pgs. 17-18).
The teachings from Heller have been removed as prior art and the arguments against them will not be addressed.
The Applicant argues that Yang is insufficient and non-enabling for the requirements of claims 1 and 35 (Remarks, pg. 18).
Applicant’s argument is not found persuasive. Yang teaches films with active components (abs). Yang teaches silicon dioxide in amounts of 0.02 to 1% as texturing agents (para. 159). One of ordinary skill in the art at the time of instant filing would have included the silicon dioxide in amounts of the examined claims by teachings of Yang which indicates that adding silicon dioxide as a texturing agent would be useful to the film formulation like that of Schobel ‘198.
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