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 .
Applicant’s arguments, filed 12/26/2025, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Status
Claims 14, 16-21, and 25-37, are pending and under examination.
Claim Objections
Claim 27 is objected to because of the following informalities: a comma is missing following “claim 26”. Appropriate correction is required.
Claim Rejections - 35 USC § 112(a) or pre-AIA 1st ¶
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.
Claim 14, 16-21, and 30-35, 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.
Claim 14 recites the limitation of “wherein the oral film formulation has a surface pH of less than 5.” This limitation does not appear to have support in the instant specification. While the limitation of an oral film formulation having a pH of less than 5 appears to have support, there appears to be no disclosure of a “surface pH.” Accordingly, the limitation appears to be new matter. For purposes of examination, the limitation will be interpreted as wherein the oral film formulation has a pH of less than 5.
Claims 16-21 are also rejected for the same reasons for depending upon rejected claim 14.
Claim 30 recites the limitation of “further comprising an agglomeration inhibitor selected from the group consisting of… methyl cellulose.” While methyl cellulose (MC) of aqueous viscosity up to 5040 mPas (2%, 20 C) appears to have support, the specification excludes methyl cellulose (see ¶ 63). Accordingly, the limitation appears to be new matter.
Claims 31-35 are also rejected for the same reasons for depending upon rejected claim 30.
Claim Rejections - 35 USC § 112(b) or pre-AIA 2nd ¶
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 26-37 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 26-37 recite the limitation "the oral film formulation" in line 1 of each claim. There is insufficient antecedent basis for this limitation in the claims. The claims depend from claim 25 where an “oral film dosage form” is claimed, and there appears to be no recitation of an “oral film formulation.” Accordingly, the limitations lack antecedent basis.
Claim 26 also recites the limitation “wherein the low solubility API is maropitant” in line 1. There is insufficient antecedent basis for this limitation in the claim. The claim depends from claim 25, where there is no “low solubility API” claimed. Accordingly, the limitation lacks antecedent basis.
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.
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 14, 16-21, 25-34, 36, and 37, are rejected under 35 U.S.C. 103 as being unpatentable over Paiement et al (US 20190133925 A1, cited on IDS dated 08/03/2023), in view of Liu (CN 109172547 A) and Boeren et al (EP 3173071 A1), as evidenced by Ashland (Klucel™ hydroxypropylcellulose, 2017, pp. 1-24) and Gattefosse (Lipid-based formulations, 2020, pp. 1-6).
Paiement et al teach oral film formulations for improved bioavailability of an active (abs). In embodiments, the oral film formulation comprises montelukast sodium at 16.12 wt% (API), locust bean gum at 4.30 wt% (suspending agent, see instant claim 27), povidone at 54.12 wt% (i.e., PVP, mucoadhesive film former and agglomeration inhibitor, see ¶¶ 63 and 92 of the instant spec), HPC-GXF at 10.31 wt%, PEG-300 at 4.3 wt% (non-amphiphilic solubility enhancer, see ¶ 61 of the instant spec), Labrafil M1944CS at 4.35 dry wt% (surfactant, HLB value of 9, see ¶¶ 59 and 94 of the instant spec and pg. 3 of Gattefosse), methanol at 0.2 wt% (co-surfactant, see instant table 10), propylparaben at 0.49 wt% (preservative agent, see ¶ 64 of instant spec), citric acid (flavor enhancer, see ¶ 68 of instant spec), sucralose (sweetener, see ¶ 69 of instant spec), etc. (table 14). HPC-GXF and HPC-LF are both taught as film forming polymers (see for example tables 7 and 14). As evidenced by Ashland, HPC-LF has a molecular weight of 95,000 daltons and a viscosity of 75-150 mPas (see table 2). Some residual solvents remain in the dry compositions (¶ 102). The films may also comprise sorbitol (plasticizer) and menthol (flavor) (table 16). Other suitable film forming polymers which include HPMC (¶ 73, table 9, 17). The films may comprise up to 37.18 wt% API with a dosage up to 70 mg (¶ 88, table 20). Labrafil is taught as a permeation enhancer, with embodiments comprising permeation enhancers in amounts up to 7.34 wt% (table 5). Penetration (permeation) enhancing agents, including surfactants, can be advantageously employed to increase the rate and/or total absorption of active agent in (¶ 74). Examples of suitable surfactants that can be employed to enhance penetration and/or wettability include polyethoxylated alcohols, ethanol, propylene glycol, etc. (¶ 76). It was found that the use of a single or combination of penetration enhancers greatly increased permeation and absorption of the active when present in the formulation in the range of 0.05-8.00% dry w/w (¶ 74). Penetration enhancers include cyclodextrin, etc. (¶ 74). Suitable film formers include HPC, HPMC, PEO, PVP, pullulan, etc. (¶ 73). The film forming polymers can comprise about 40.0 to 99.0 dry wt% (¶ 79). The film forming polymers and active agent can be blended to obtain a balanced combination of properties like flexibility, tensile strength, uniformity of the film and drug, hydration speed, drug release, disintegration time, palatability, mouth feel, mucoadhesion, chemical and physical stability, etc. (¶ 72).
The references does not specifically teach a low water solubility API, nor an acidic pH of the oral film formulation.
Liu teaches it was known to formulate maropitant in oral film formulations (abs, pg. 3).
Liu does not specifically teach the pH of the oral films.
Boeren et al teach it was known to formulate maropitant formulations with pH values between 3 and 6 (abs, ¶ 54).
Regarding the low water solubility API of claim 14, it would have been obvious to modify the oral film formulations of Paiement et al to include other active agents that were known to be suitable for oral film formulations, such as maropitant, as taught by Liu, in the same amounts for API taught to be suitable for the oral formulations, such as up to 37.18 wt%, as taught by Paiement et al above. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I). Further, it would have been well within the relative skills of the skilled artisan to routinely optimize the amount of maropitant for desired therapeutic activity and uses. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. Where 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. See MPEP 2144.05(II)(A).
Regarding the surfactant having an HLB of 7 or higher of claim 14, the oral film formulation of Paiement et al cited above comprises Labrafil M1944CS, which is evidenced by the instant specification as having an HLB value of 9.
Regarding the acid pH of claim 14, where the pH of the oral formulations of Paiement et al are chosen for compatibility with the API used, it would have been obvious upon substituting maropitant for the active of Paiement et al, to modify the pH of the oral films to those known to be suitable for maropitant formulations, such as between 3 and 6, as taught by Boeren et al, thereby reading on an acidic pH. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
Regarding the wt% API of claim 14, it would have been obvious to modify the oral film formulations of Paiement et al to include other active agents that were known to be suitable for oral film formulations, such as maropitant, as taught by Liu, in the same amounts for API taught to be suitable for the oral formulations, such as up to 37.18 wt%, as taught by Paiement et al above, such as 22 wt%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
Regarding claim 16, where maropitant is made obvious above, the limitation is met.
Regarding claim 17, where the oral film formulation of Paiement et al comprises the surfactants Labrafil M1955CS and methanol, it would have been obvious to substitute methanol for other suitable surfactants taught by Paiement et al, such as ethanol, propylene glycol, etc., which appear to meet the limitation of the co-surfactants instantly claimed.
Regarding claim 18, the oral film formulation made obvious above comprises povidone (PVP), which appears to read on the limitation of a mucoadhesive film former for the reasons discussed above. Even if not, it would have been obvious to add or substitute other suitable film formers, such as HPMC, which appears to read on a mucoadhesive film former, for the same reasons discussed above.
Regarding claim 19, it would have been obvious to include flavors, such as menthol, as taught by Paiement et al, in order to achieve desired taste of the oral film formulation.
Regarding claim 20, the oral film made obvious above comprises citric acid (flavor enhancer, see ¶ 68 of instant spec), thereby meeting the claimed limitation.
Regarding claim 21, the oral film formulation made obvious above comprises propylparaben, which appears to read on a preservative agent (see ¶ 64 of instant spec).
Regarding claim 25, from the working example of Paiement et al discussed above, it would have been obvious to formulate an oral film dosage form comprising an active pharmaceutical ingredient, mucoadhesive film formers, PEG-300 (non-amphiphilic solubility enhancer), Labrafil M1944CS (surfactant, HLB of 9), locust bean gum (suspending agent, see claim 27), povidone (i.e., PVP, agglomeration inhibitor, see claim 30), etc.
Regarding the mucoadhesive film former of claim 25, it would have been obvious to select from PEO, HPC, HPMC, pullulan, etc., and combinations thereof, as film formers, as taught by Paiement et al.
Regarding the amphiphilic solubility enhancer, it would have been obvious for the skilled artisan to substitute HPC-LF for HPC-GXF, and in the same amounts, where both are taught to be suitable for the same purpose. HPC-LF appears to read on an amphiphilic solubility enhancer, where the instant specification recites that amphiphilic solubility enhancers include HPC with a MW up to 95,000 with a viscosity of no more than 150 mPas (see ¶ 61 of the instant spec, see also claim 25).
Purely arguendo, if somehow HPC LF does not read on the limitation, it would have been obvious to further include penetration enhancers including cyclodextrin, etc., in order to enhance penetration and/or wettability where it was known that the use of a single or combination of penetration enhancers greatly increased permeation and absorption of the active, as taught by Paiement et al. The examiner notes that cyclodextrin appears to meet limitation of an amphiphilic solubility enhancer, as evidenced by the instant claim.
Regarding the wt% of API of claim 25, it would have been obvious to include the active agent up to 37.18 wt%, as taught by Paiement et al above. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
Regarding the weight ratio of amphiphilic to non-amphiphilic solubility enhancer of claim 25, where the wt% of HPC made obvious above is 10.31 wt% and the wt% of PEG-300 is 4.3 wt%, the resulting weight ratio is 10.31:4.3 (i.e., 2.4:1), falling within the claimed range.
Regarding claim 26, it would have been obvious to modify the oral film formulations made obvious above to include other active agents that were known to be suitable for oral film formulations, such as maropitant, as taught by Liu, in the same amounts for API taught to be suitable for the oral formulations, such as up to 37.18 wt%, as taught by Paiement et al above. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
Regarding claim 27, the oral film composition made obvious above comprises locust bean gum, appearing to meet the limitation of a suspending agent as evidenced by the instant claim.
Regarding claim 28, where the amount of active agent can be included up to 37.18 wt% from the working embodiments of Paiement et al, and the amount locust bean gum (suspending agent) to API in table 14 is 4.30 wt%, the resulting ratio at 22 wt% API is 4.30:22 (about 1:5.12), falling within the claimed range. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).appearing to meet the limitation of “about” 1:5.
Further, it would have been well within the relative skills of the skilled artisan to routinely adjust the amount of active and suspending agent in order to achieve desired oral film properties. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. Where 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. See MPEP 2144.05(II)(A).
Regarding claim 29, where the oral film formulation made obvious above comprises locust bean gum at 4.30 wt%, and Labrafil M1944CS at 4.35 wt%, and where Paiement et al teaches permeation/penetration enhancers may range from 0.05-8.00 wt%, it would have been obvious for the skilled artisan to adjust within that range were Labrafil M1944CS is taught as a permeation (i.e., penetration) enhancer. Further, it would have been well within the relative skills of the skilled artisan to routinely adjust the amount of locust bean gum (taught as a thickener) and surfactant in order to achieve desired film properties, such as to within the ratios instantly claimed, where the amount of locust bean gum would be expected to adjust the thickness of the formulations.
Further, it would have been well within the relative skills of the skilled artisan to routinely adjust the amount of locust bean gum and Labrafil M1944CS, in order to achieve desired film properties, therapeutic activity, etc. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. Where 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. See MPEP 2144.05(II)(A).
Regarding claim 30, the oral film composition made obvious above comprises povidone (i.e., PVP), appearing to meet the limitation of an agglomeration inhibitor of claim 30.
Regarding claim 31, it would have been obvious to include additional surfactants such as ethanol, propylene glycol, etc., in order to enhance permeation, absorption, and wettability of the API, as taught by Paiement et al. Note, it appears that ethanol and propylene glycol meets the limitation of the instantly claimed co-surfactants, as evidenced by the instant claim.
Regarding claim 32, where the co-surfactant and surfactant made obvious above are taught as penetration enhancers, and where penetration enhancers can range from 0.05-8.00 wt% of the film, it would have been obvious for the skilled artisan to adjust each component within that range, overlapping the instantly claimed ratio.
Regarding the ratio of co-surfactant to API of claim 32, where co-surfactant ranging from 0.05-8.00 wt% is made obvious above, and where the amount of API can vary, such as up to 37.18 wt%, as taught by Paiement et al, it would haven obvious for the skilled artisan to adjust within these ranges in order to achieve desired oral film formulation properties, penetration, therapeutic activity, etc. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. Where 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. See MPEP 2144.05(II)(A).
Regarding claim 33, it would have been obvious to formulate the oral film formulation made obvious above where the suspending agent, the mucoadhesive film former, the agglomeration inhibitor, the surfactant, and the co-surfactant, are distinct components, as discussed above.
Regarding claim 34, where the film forming polymers can range from about 40.0-99.0 wt%, and the API can be adjusted up to 37.18 wt% in embodiments, the resulting ratio would be about 1:0.93 at 40.0 wt% film former and 37.18 wt% active agent, overlapping the claimed range. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I). Further, it would have been well within the relative skills of the skilled artisan to routinely adjust the amount of film former and API, in order to achieve desired film properties, therapeutic activity, etc., where the blend of active agent and film forming polymers can be balanced in order to achieve desired combination of properties including flexibility, drug release, disintegration time, mouth feel, etc., as taught by Paiement et al. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. Where 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. See MPEP 2144.05(II)(A).
Regarding claim 36, the ratio of surfactant to API in table 14 is 4.35:16.12 (i.e., 1:1.4) increasing up to 4.35:37.18 (i.e., about 1:8.5) with increasing amount of API, overlapping the claimed range. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
Regarding claim 37, the oral film formulation made obvious above comprises propylparaben, which appears to be a preservative agent as evidenced by the instant specification above.
Regarding the ratios, where the oral film formulation made obvious above comprises a preservative agent and varying amounts of API, it would have been well within the relative skills of the skilled artisan to routinely optimize the ratio of preservative to API, in order to achieve optimal preservation of the formulations, such as to within the ranges instantly claimed. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. See MPEP 2144.05(II)(A).
Response to Arguments
Applicants assert Paiement et al fail to disclose a formulation meeting the limitation of at least 37% by weight of API and a surfactant having an HLB of 7 or higher. Applicants assert while the Office points to Paiement et al’s teaching of API amounts “up to 37.18 wt%,” this represents a maximum value, not a teaching of formulations wherein the API is present in an amount of at least 37% as now claimed. Applicants assert Labrafil M1944CS has a reported HLB of approximately 4, falling below the claimed threshold of 7 or higher.
Respectfully, this argument is not persuasive. Applicants appear to assert that 37.18 wt% as a maximum value does not meet the newly amended limitation of at least 37%, however, 37.18 wt% clearly falls within the range of at least 37%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I). Further, it would have been well within the relative skills of the skilled artisan to routinely optimize the amount of maropitant for the same reasons discussed above. See MPEP 2144.05(II)(A).
Regarding Labrafil M1994CS, while Applicants assert Labrafil M1944CS has an HLB value of approximately 4, the instant specification and Gattefosse evidences that Labrafil M1994CS has an HLB of 9, falling within the claimed range.
Claim 35 is rejected under 35 U.S.C. 103 as being unpatentable over Paiement et al (US 20190133925 A1, cited on IDS dated 08/03/2023), Liu (CN 109172547 A), and Boeren et al (EP 3173071 A1), as applied to claims 14-21, 25-34, 36, and 37 above, and further in view of Zerbe et al (US 20180110724 A1, cited on IDS dated 08/03/2023).
The references are discussed above and while components meeting the limitation of agglomeration inhibitors with varying amounts of polymer and API, the reference does not specifically teach the weight ratio of agglomeration inhibitor to API of instant claim 35.
Zerbe et al teach oral film dosage forms with improved solubility and stabilization of an active ingredient, comprising at least one primary crystallization inhibitor that inhibits growth and/or agglomeration of the active ingredient (abs). Suitable agglomeration inhibitors include polyvinyl pyrrolidone, polyethylene oxide, poloxamer, PEG, etc. (¶ 49). The agent for inhibiting agglomeration of active ingredients generally ranges from about 0.5% to 19% of the mass of the film dosage form, with the amount of drug ranging from 0.01 to 50 wt% of the film (¶¶ 19, 20). Agglomeration of active ingredients results in loss of solubility and decreased bioavailability due to particle size growth (¶ 7).
Regarding claim 35, it would have been obvious to modify the oral film formulation made obvious above to include known amounts of agglomeration inhibitors, such as polyvinyl pyrrolidone (i.e., PVP), suitable for inhibiting agglomeration of the active ingredient, such as about 0.5 to 19% of the mass of the film, as taught by Zerbe et al, thereby overlapping the ratio of agglomeration inhibitor to API instantly claimed. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
Further, it would have been well within the relative skills of the skilled artisan to adjust the amount of surfactant to API ratio in order to achieve optimal stability properties, where the reference teaches both the permeation enhancers (instant surfactants) and API amounts can vary. See MPEP 2144.05(II)(A).
Response to Arguments
Applicants have not provided arguments with respect to the teachings of Zerbe et al. Accordingly, the claims are rejected for the same reasons above and of record.
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 14, 16-21, and 25-37, are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 18/276,918 (reference application), hereinafter ‘918, in view of Paiement et al (US 20190133925 A1, cited on IDS dated 08/03/2023), Liu (CN 109172547 A), Boeren et al (EP 3173071 A1), and Zerbe et al (US 20180110724 A1, cited on IDS dated 08/03/2023). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims disclose an oral film formulation comprising an active agent, a mucoadhesive agent selected from hydroxypropylmethyl cellulose, hydroxypropyl cellulose, polyethylene oxide, guar gum, etc., and combinations of two or more thereof, in an amount from about 0.5 to about 20 wt%. The formulations further comprise a plasticizer, a sweetener, a penetration enhancer, and polymer selected from HPMC, povidone, copovidone, starch, hydroxypropyl cellulose, HPMC, polyethylene glycol, xanthan gum, and combinations of two or more thereof. The plasticizer ranges from 0.5-25 wt%. The film forming polymers are 10 to 90 wt%. Citric acid (flavor enhancer) may also be included. The pH is between 1.5 and 5. Penetration enhancers can also be included. The oral film can be administered buccally.
The claims of ‘918 do not disclose the amount of active as instantly claimed, a specific embodiment as instantly claimed comprising the claimed combination of components, nor the ratios, the inclusion of a preservative agent, nor wherein the API is maropitant.
The references are discussed above.
Regarding the amount of active, it would have been obvious for the skilled artisan to adjust the amount of active agent to known amounts suitable for oral film formulations, such as those taught by Paiement et al above.
It would have been obvious for the skilled artisan to modify the oral film formulation of ‘918, by formulating known combinations of mucoadhesive film former, amphiphilic solubility enhancer, non-amphiphilic solubility enhancer, suspending agent, agglomeration inhibitor, co-surfactant, etc., as instantly claimed, and in known amounts and ratios, for the same reasons made obvious above by Paiement et al, Liu, Boeren et al, and Zerbe et al, and where the claims of ‘918 disclose the amount of components can vary. See MPEP 2144.05(II)(A). Further, it would have been obvious for the skilled artisan to routinely optimize the amounts and ratios in order to achieve desired therapeutic activity, film properties, for the same reasons discussed above. See MPEP 2144.05(II)(A).
It would have been obvious to include known preservatives known to be suitable for oral film formulations, such as those taught by Paiement et al.
It would have been obvious to include other known active agents suitable for oral film formulations, such as maropitant, as taught by Liu.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 14, 16-21, and 25-37, are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 18/386,113 (reference application), hereinafter ‘133, in view of Paiement et al (US 20190133925 A1, cited on IDS dated 08/03/2023), Liu (CN 109172547 A), Boeren et al (EP 3173071 A1), and Zerbe et al (US 20180110724 A1, cited on IDS dated 08/03/2023). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims disclose an oral film formulation comprising cannabis (active agent), at least one film forming polymer, at least one mucoadhesive polymer, at least one solubilizer, at least one surfactant, at least one co-surfactant, at least one permeation enhancer, at least one stabilizer, at least one flavor agent, at least one sweetening agent, etc. The polymers include PVP, HPMC (mucoadhesive film former and agglomeration inhibitor), copovidone, PEO (mucoadhesive film former), PEG 300 (non-amphiphilic solubility enhancer, plasticizer), hydroxypropyl cellulose (amphiphilic solubility enhancer and viscosity increasing agent, see instant ¶ 58), etc. Solubilizers include ethanol, etc. Permeation enhancers include PEG 300, Tween 20, etc. (surfactants). The ratio of cannabinoid to polymers is about 1:6 to about 1:1. The ratio of cannabinoid to solubilizers are about 1:1 to about 2:1. The ratio of cannabinoid to surfactant is 1:1 to 1:4. The ratio of cannabinoid to permeation enhancer is about 1:3 to about 1:1. The oral formulation comprises 1 to 25 wt% cannabis.
‘133 does not teach a specific embodiment as instantly claimed comprising the claimed combination of components, preservative agents, an acidic pH, nor maropitant as the active.
The references are discussed above.
Regarding the components, it would have been obvious for the skilled artisan to select among the suitable components disclosed by ‘133, thus arriving at the claimed combination. Additionally, it would have been obvious to modify the compositions to include other known components suitable for oral film formulations, and in known amounts, such as those taught by Paiement et al and Zerbe et al above and for the same reasons.
It would have been obvious for the skilled artisan to start with the ratios of components taught by ‘133 and adjust from there in order to routinely optimize the amounts and ratios in order to achieve desired therapeutic activity, film properties, for the same reasons discussed above. See MPEP 2144.05(II)(A).
Regarding the inclusion of a preservative agent, it would have been obvious to include known preservatives known to be suitable for oral film formulations, such as those taught by Paiement et al.
Regarding the pH and maropitant, it would have been obvious to include other known active agents suitable for oral film formulations, such as maropitant, as taught by Liu. Further, it would have been obvious to formulate the oral films with a known pH compatible with maropitant, such as those taught by Boeren et al above.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicants request the double patenting rejection be held in abeyance.
The examiner acknowledges Applicants’ request. Accordingly, the claims stand rejected for the same reasons above.
Claims 14, 16-21, and 25-37, are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 18/208,177 (reference application), hereinafter ‘177, in view of Paiement et al (US 20190133925 A1, cited on IDS dated 08/03/2023), Boeren et al (EP 3173071 A1), and Zerbe et al (US 20180110724 A1, cited on IDS dated 08/03/2023). Although the claims are not identical they are not patentably distinct because the claims of ‘177 disclose an oral film comprising an active agent, polymers selected from hydroxypropyl methylcellulose (mucoadhesive film former and agglomeration inhibitor), polyethylene oxide (mucoadhesive film former), polyethylene glycol (non-amphiphilic solubility enhancer, co-surfactant), hydroxypropyl cellulose (amphiphilic solubility enhancer), polylactic acid, etc. Emulsifiers selected from guar gum (viscosity increasing agent, see ¶ 58 of the instant spec), etc. The oral films further comprise surfactants. The oral films further comprise sweeteners, flavors, and taste modifiers. The oral films further comprise plasticizers, and the active may be maropitant. The pH ranges from about 7.5 to about 8.5.
‘177 does not disclose a specific embodiment as instantly claimed comprising the claimed combination of components, the amount of active agent, the specific ratios claimed, nor a pH of less than 5.
The references are discussed above.
Regarding the components, it would have been obvious for the skilled artisan to select among the suitable components disclosed by ‘177, thus arriving at the claimed combination. Additionally, it would have been obvious to modify the compositions to include other known components suitable for oral film formulations, and in known amounts, such as those taught by Paiement et al and Zerbe et al above and for the same reasons.
Regarding the amount of active agent, it would have been obvious for the skilled artisan to adjust the amount of active agent to known amounts suitable for oral film formulations, such as those taught by Paiement et al above.
Regarding the ratios between the components, when formulating the oral film, it would have been well within the relative skills of the skilled artisan to adjust the ratios of the components in order to achieve desired and optimal oral film properties. See MPEP 2144.05(II)(A).
Regarding the pH, it would have been obvious to adjust the pH to other known pH ranges suitable for maropitant formulations, such as those of Boeren et al above.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicants request the double patenting rejection be held in abeyance.
The examiner acknowledges Applicants’ request. Accordingly, the claims stand rejected for the same reasons above.
Claims 14, 16-21, and 25-37, are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 18/110,879 (reference application), hereinafter ‘879, in view of Paiement et al (US 20190133925 A1), Liu (CN 109172547 A), and Zerbe et al (US 20180110724 A1, cited on IDS dated 08/03/2023). Although the claims are not identical they are not patentably distinct because the claims of ‘879 disclose an oral film for human or animal administration comprising a lipophilic active, a carrier oil selected from MCT (non-amphiphilic solubility enhancer, see ¶ 61 of the instant spec), etc., film forming polymers selected from cellulose derivatives, PVA (mucoadhesive film former), PVP (agglomeration inhibitor), PEO (mucoadhesive film former, amphiphilic solubility enhancer), starches (mucoadhesive film former), polyacrylates, gums (viscosity increasing agent), and mixtures thereof, and a combination of surfactants. The oral film further comprises a viscosity modifier. The oral film has a surface pH from about 4 to less than 5.5.
‘879 does not disclose a specific embodiment as instantly claimed comprising the claimed combination of components, the amount of API nor the ratios of components as instantly claimed, preservative agents, flavor and flavor enhancers, sweeteners, nor wherein the active agent is maropitant.
The references are discussed above.
Regarding the components, it would have been obvious for the skilled artisan to select among the suitable components disclosed by ‘879, thus arriving at the claimed combination. Additionally, it would have been obvious to modify the compositions to include other known components suitable for oral film formulations, and in known amounts, such as those taught by Paiement et al and Zerbe et al above and for the same reasons.
Regarding the amount of active, it would have been obvious for the skilled artisan to adjust the amount of active agent to known amounts suitable for oral film formulations, such as those taught by Paiement et al above.
Regarding the ratios, when formulating the oral film, it would have been well within the relative skills of the skilled artisan to adjust the ratios of the components in order to achieve desired and optimal oral film properties. See MPEP 2144.05(II)(A).
Regarding the flavors, flavor enhancers, and sweeteners, it would have been obvious to include known additives suitable for oral film formulations, such as sweeteners, flavors, and flavor enhancers, as taught by Paiement et al above and for the same reasons.
Regarding maropitant, it would have been obvious to include other known active agents suitable for oral film formulations, such as maropitant, as taught by Liu.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicants request the double patenting rejection be held in abeyance.
The examiner acknowledges Applicants’ request. Accordingly, the claims stand rejected for the same reasons above.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSHUA A ATKINSON whose telephone number is (571)270-0877. The examiner can normally be reached M-F: 9:00 AM - 5:00 PM + Flex.
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/JOSHUA A ATKINSON/
Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
Prosecution Insights