DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status
Claim 46 appears to be newly added.
Claims 1-46 are currently pending.
Claim 35-45 are withdrawn.
Claims 1-34 and 46 are being examined on the merits.
Non-Compliant Claim Amendment
Claim 46 is missing status identifier.
Claims 35-45 are withdrawn claims, which must include the text of the said claims.
In order to be fully responsive to the instant office action applicant must fully comply with the rules for claim amendments.
See MPEP 714 37 C.F.R 1.121 (c) Claims. Amendments to a claim must be made by rewriting the entire claim with all changes (e.g., additions and deletions) as indicated in this subsection, except when the claim is being canceled. Each amendment document that includes a change to an existing claim, cancellation of an existing claim or addition of a new claim, must include a complete listing of all claims ever presented, including the text of all pending and withdrawn claims, in the application. The claim listing, including the text of the claims, in the amendment document will serve to replace all prior versions of the claims, in the application. In the claim listing, the status of every claim must be indicated after its claim number by using one of the following identifiers in a parenthetical expression: (Original), (Currently amended), (Canceled), (Withdrawn), (Previously presented), (New), and (Not entered).
Priority
Receipt is acknowledged of papers submitted under 35 U.S.C 119 (a)-(d) for Application No.IN202341030784, filed on 04/28/2023; as reflected in the filing receipt issued on 08/29/2023.
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in India on 4/28/23. It is noted, however, that applicant has not filed a certified copy of the IN202341030784 application as required by 37 CFR 1.55.
Election/Restrictions
Applicant's election with traverse of Group I (claims 1-34 and 46) in the reply filed on September 15, 2025 is acknowledged. The traversal is on the ground(s) that the cited prior art references do not teach the claimed oral dispersible film.
This is not found persuasive because Kariman teaches extract mitragynine, used as a potent analgesic. Reference also teaches that the Mitragyna speciosa contains natura substance, which is purified mitragynine. Kale et al teaches an oral film delivering an active ingredient to the oral cavity that dissolves after a delay of at least 5 second of contact with the oral mucosa. Reference also teaches the film comprises forming polymers.
The requirement is still deemed proper and is therefore made FINAL.
Claims 35-45 withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected group invention and species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on October 21, 2025..
Accordingly, claims 1- 34 and 46 are being examined on the merits herein.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. This application is a 371 of PCT/IN2023/050630 (06/28/2023) which claims priority to FOR INDIA IN202341030784 (04/28/2023) as reflected in the filing receipt issued August 29, 2023.
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in India on4/28/2023. It is noted, however, that applicant has not filed a certified copy of the IN202341030784 application as required by 37 CFR 1.55.
Information Disclosure Statement
There was not an IDS provided.
Claim Rejections - 35 USC § 103
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.
Claims 1-34, and 46 are rejected under 35 U.S.C 103 as being unpatentable over Chadeayne et al (WO2021/076849; published on April 22,2021; filled on October 16,2020) in view of Kataria (WO2018/127938; published on April 22,2021; filled on October 16, 2020), Kale et al (WO2010/146601; published on December 23,2013; filled on June 15,2010), and Kruegel et al (WO2017/165738; published on September 28,2017; filled on March 24,2017).
Claim 1 is drawn to “An oral dispersible film of Mitragynine comprising:
Purified Mitragynine;
One or more film forming polymers;
One of more disintegrants;
One of more stabilizers; and
Optionally, one or more flavouring agents.”
Chadeayne et al throughout teaches composition comprising of mitragynine and pharmaceutical formulation. (e.g. Abstract).
For Claim 1, Chadeayne et al teaches composition comprising, consisting essentially of, or consisting of a first purified kratom compound, mitragynine (e.g. para 3; claim 1) The formulation of a composition of the disclosure may contain additional inactive compounds, such as excipients, binders, stabilizers, permeation enhancers, solubilizers, etc. (e.g. paragraph 25).
For Claim 2: Chadeayne et al teaches separate composition of two of these purified kratom compounds or a salt thereof (e.g. paragraph 20; claim 1).
For Claims 3-5, 8-10: Chadeayne et al teaches that the kratom compound may have been chromatographed, for example by gas chromatography, liquid chromatography (e.g., LC, FIPLC, etc.), flush column chromatography, etc. or subject to crystallization, distillation, or sublimation (e.g. paragraph 34). Reference also teaches purified compound is a compound that is 80-100% pure, 90-100% pure or 95-100% pure. Within the context of this disclosure, the term "purified" means separated from other materials, such as plant or fungal material, e.g., protein, chitin, cellulose, or water. A purified compound is substantially free of other materials (e.g. paragraph 34).
Chromatography by the above mentioned would result in a crystalline or amorphous form with the desired purity. Terms crystalline and amorphous are not defined in the instant specification. The term crystalline is interpreted as purified mitragynine highly ordered and distinctly shaped. Amorphous is interpreted as the purified mitragynine lacking ordered structure.
For claim 16: Chadeayne et al teaches pharmaceutical formulation a composition be admixed with starches, lactose, sucrose, glucose, mannitol (paragraph 25).
For claim 19 and 20: Reference also teaches pharmaceutical formulation adjuvants known in the pharmaceutical formulation art may also be used in the pharmaceutical compositions of the invention which include, but are not limited to, preserving, wetting, suspending, sweetening, flavoring, perfuming, emulsifying, and dispensing agents (paragraph 25).
For claim 46: Chadeayne et al teaches purified mitragynine (kratom) extracted for Mitragynia speciosa plant (paragraph 11).
Chadeayne et al does not teach film formulation with the polymer such as hydroxypropylmethyl cellulose (HPMC) of claims 1 and 10-11 in the amount as recited in claim 12. The reference also does not teach “the purified mitragynine salt …purified Mitragynine oxalate salt …,” as recited in claims 6-7. Chadeayne also does not teach “the disintegrants… concentration of 1-100 mg per film” recited in claims 13-15. Reference does not teach “the stabilizers… concentration of 0.5-50 mg per film” as listed and claims 16-18. Reference does not teach “cherry, peppermint, ginger, clove, spearmint, or coffee with mint …preservatives and plasticizers… at a concentration of…” discussed and listed in claims 21-28. Reference does not teach “water is added as a bulk medium” recited in claim 29. Chadeayne also does not teach “the thickness of the film is 0.6-0.8 mm… disintegration time of the film is between” recited in claims 30 and 31. Chadeayne also does not teach “Mitragynine, comprising: i. Purified Mitragynine oxalate salt: 5-200 mg/film; ... Water: q.s.” recited in claim 32. Reference does not teach “Thickness of film is 0.6-0.8 mm Endurance is 3-4 kp pH value: 2.0 to 3.2 Disintegration time is 50-60 sec… purified Mitragynine is obtained from Mitragyna speciosa” recited in claims 33 and 34.
However, Kale et al, throughout the reference, teaches oral film that dissolves within at least 5 seconds of contact with oral mucosa.
For Claims 11 and 12: Kale et al teaches oral film comprised of polyvinyl alcohol polyethylene glycol graft polymer, is present in the film composition to the extent of between 5% and 50%, more preferably 5% - 40% by weight of the film composition (claim 6 step a).
Kale et al also teaches the film polymer are selected from group consisting of, hydroxypropyl methyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, carboxy methyl cellulose, guar gum, carboxy methyl guar gum, carboxy methyl locust bean gum, acacia gum, arabic gum, pectin, chitosan, mixtures thereof and the like polymers to the extent of between 10% and 50% by weight of the film composition (e.g. claim 6 step b).
For claim 13 -15: Kale teaches selected from the group consisting of synthetic sweeteners and natural sweeteners such as sorbitol, hexitol, Maltitol, xylitol, mannitol, aspartame, saccharine sodium, sucralfate, alitame, cyclamate, acesulfame and the like; in an amount ranging from about 0.2% to about 20% by weight and preferably about 2% to about 15% by weight (e.g. claim 6 step e)
For claim 19: Kale teaches flavorings comprise of synthetic flavor oils and flavoring aromatics, and/or essential oils and their mixtures including but not limited to lemon oil, orange oil, lemon grass oil, cinnamon oil, clove oil, ginger oil, spearmint oil, peppermint oil, eucalyptus oil, oil of nutmeg, Mentha piperita (menthol), methyl salicylate, peppermint, vanilla and the like (e.g. Claim 6 step n).
For Claim 20: Kale teaches flavoring agents particularly an essential oil which act as breath freshening agent. The film further comprises of solvent, plasticizing agents, flavoring agents, surfactants, emulsifying agents, antioxidants, preservatives, sweeteners and fragrances (e.g. claim 5)
For Claims 27 and 28: Kale teaches plasticizer is selected from the group polyethylene glycol, N propylene glycol, glycerin, polysorbates to the extent between 0.5 to 15 %, more preferably between 1 to 8.5 % by weight of the film composition (e.g. claim 6 step l).
For Claim 31: Kale teaches oral film requires at least a delay of about 5 seconds after coming in contact with oral mucosa to stick to the mucosa surface in contact and rapidly dissolves thereafter (e.g. claim 1). Reference also teaches that the film of this invention takes a about 5 seconds to hydrate so that adequate time is available for its maneuvering inside oral cavity for locating it at preferred location, but rapidly dissolves after hydration. Total time needed to disintegrates is about 1 min (e.g. claim 28).
Kataria, throughout the reference, teaches oral dispersible film composition.
For claims 17 and 18: Kataria teaches oral dispersible film composition comprising: (a) maltodextrin; (b) hydroxypropyl cellulose; (c) plasticizer; (d) at least one active ingredient; (e) at least one saliva stimulating agent; and (f) excipient, wherein the weight ratio of maltodextrin to hydroxypropyl cellulose is in the range of 1: 1 - 3:1, and the weight ratio of maltodextrin to hydroxypropyl cellulose to plasticizer is in the range of 3:1:1 - 3: 1:3 ( paragraph 0076).
For Claim 21-23: Kataria teaches the preservative is selected from the group consisting of sodium benzoate, benzalkonium chloride, potassium sorbate, methyl paraben, propyl paraben, and combinations thereof (e.g. paragraph 0087). More specifically the reference teaches the preservative is sodium benzoate, benzalkonium chloride, and combinations thereof (e.g. paragraph 0088). Kataria also teaches Preservatives like potassium sorbate, sodium benzoate, methyl and propyl paraben were also optimized along with the anti-sticking agents. The results of the optimization have been summarized in Table 6 (e.g. paragraph 00126). Reference demonstrated the working range of the anti- sticking agent would be 0.05-8% w/w and that of the preservative in the range of 0.01-3% w/w respectively (e.g. paragraph 00127).
For Claim 24, 25 and 26: Kataria teaches the sweetener is selected from the group consisting of sucralose, xylose, ribose, glucose, mannose, galactose, fructose, dextrose, sucrose, maltose, partially hydrolyzed starch, corn syrup solids, xylitol, mannitol, saccharin salts, cyclamate salts, acesulfam-K, aspartame, neotame, and combinations thereof (e.g. paragraph 0082). Reference also teaches more specifically the chosen sweetener is sucralose (e.g. paragraph 0084). Kataria teaches the sweetener has a weight percentage in the range of 0.1 - 5.0% with respect to the composition. (e.g. paragraph 0081).
For Claim 29: Kataria teaches components were combined and working ranges were established for the various components. The summary of the working range and role of all the components of the composition have been summarized in Table 7 (e.g. paragraph 00128). Table 7 of reference teaches the ingredient, role and working range of the ingredient. The instant specification discloses an example of generalized oral dispersible film components (instant spec. table 1).
For claim 30: Kataria teaches the oral dispersible film composition has an average thickness in the range of 0.04 - 0.8 mm (e.g. claim 6).
For Claims 6-8: Kruegel et al teaches pharmaceutically acceptable salts include, but are not limited to, mineral or organic acid salts of basic residues such as amines; alkali or organic salts of acidic residues such as phenols; alkali or organic salts of acidic residues such as carboxylic acids. The salts can be made using an organic or inorganic acid (e.g. lines 25-35 page 54). Salts can be prepared in situ during the final isolation and purification of the compounds of the invention, or by separately reacting a purified compound of the invention in its free base or free acid form with a suitable organic or inorganic acid or base, and isolating the salt thus formed (e.g. lines 1-5 page 53). Representative salts include the hydrobromide, hydrochloride, sulfate, bisulfate, phosphate, nitrate, acetate, valerate, oleate, palmitate, stearate, laurate, benzoate, lactate, phosphate, tosylate, citrate, maleate, fumarate, succinate, tartrate, napthylate, mesylate, glucoheptonate, lactobionate, and laurylsulphonate salts and the like (e.g. lines 5-10 page 53).
For Claim 32-34: Kataria teaches components were combined and working ranges were established for the various components. The summary of the working range and role of all the components of the composition have been summarized in Table 7 (e.g. paragraph 00128). Table 7 of reference teaches the ingredient, role and working range of the ingredient. The instant specification discloses an example of generalized oral dispersible film components (instant spec. table 1).
Kataria also teaches the film of the oral dispersible film composition, wherein the oral dispersible film composition is in the form of a film having an average thickness in the range of 0.04 - 0.8 mm (e.g. claim 6). Reference also teaches in table 1 the development of the polymer film evaluating various combinations of different polymers (in definite ratios) with maltodextrin and film endurance (e.g. 00115). Kataria also teaches the concentration of menthol, eucalyptol and sucralose was optimized according to the mouth feel, freshening effect and the formulation was checked for its effect on disintegration time (Table 5) (e.g. 00125).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to make the composition comprising mitragynine taught by Chadeayne into an oral film formulation as taught by Kale and Kataria because Chadeayne teaches oral formulation with mitragynine, and both Kale (page 3 line 9-16) and Kataria (paragraph 005) teach the advantage of using film formulation for easy dispensing and immediate release. The motivation of one of ordinary skill in the art would be obvious to modify the above mentioned to achieve the formulation of an oral dispersible film with the optimal mitragynine concentration, thickness, and disintegration.
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to make the composition comprising mitragynine taught by Chadeayne into an oral film formulation as taught by Kale and Kataria as discussed above. In addition, it would be obvious to optimize the amount of the polymer to achieve the desired concentration, thickness, endurance, and disintegration time.
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to make the composition comprising film forming polymers, stabilizers, plasticizers, disintegrants, and flavoring agents at a range of percentage by weight taught by Kale and Kataria with purified mitragynine taught by Chadeayne and Kruegel. In addition, it would be obvious to substitute film forming polymers, flavoring agents, and plasticizers at modified concentrations for desired film thickness, dissolving time, and taste.
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate using purified kratom (mitragynine) taught by Chadeayne with a pharmaceutically acceptable salt for final isolation and purification of mitragynine at various concentrations/percentage by weight taught by Kruegel. It would be obvious to substitute one pharmaceutically acceptable salt for another salt, i.e. oxalate salt, during HPLC purification of Mitragyna speciosa plant materials. The motivation of one of ordinary skill in the art would be obvious to modify the above mentioned to achieve optimal results for purified mitragynine/purified mitragynine salt where the purity is in the desired range.
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate using purified kratom (mitragynine) taught by Chadeayne with a pharmaceutically acceptable salt for final isolation and purification of mitragynine at various concentrations/percentage by weight taught by Kruegel. It would be obvious to substitute one pharmaceutically acceptable salt for another salt, i.e. oxalate salt, during HPLC purification of Mitragyna speciosa plant materials and film forming polymers, stabilizers, plasticizers, disintegrants, and flavoring agents at a range of percentage by weight taught by Kale and Kataria. The motivation of one of ordinary skill in the art would be obvious to modify the above mentioned to achieve optimal results as oral film are an attractive option for drug delivery because of the advantages they offer, such as dosing flexibility and ease of administration.
A person of ordinary skill in the art would have reasonable expectation of
success of achieving such modifications taught by Chadeayne, Kruegel, Kale and Kataria for oral dispersible film.
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 1-31 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 9,14, 20-22, and 29 of copending Application No. 19/469,394 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims would have been anticipated by the reference claims.
Instant Claim 1 is drawn to “An oral dispersible film of Mitragynine comprising:
i. Purified Mitragynine;
ii. One or more film forming polymers;
iii. One of more disintegrants;
iv. One of more stabilizers; and
v. Optionally, one or more flavouring agents.
Reference claim 1 is drawn to “An oral dispersible film of Mitragynine comprising:
i. Purified Mitragynine selected from Mitragynine free base or Mitragynine salt;
ii. One or more film forming polymers;
iii. One of more disintegrants;
iv. One of more stabilizers; and
v. Optionally, one or more flavouring agents.
The differences between the instant claim 1 and the reference claim 1 is in the Purified Mitragynine can be selected from Mitragynine free base or Mitragynine salt.
However, the differences are close enough that they would be anticipated and/or are well within the capabilities of the person of ordinary skill in the art to adjust. To rephrase, the recited claims of the instant application are so close to the reference claims that they are not mutually exclusive.
The claims at issue are identical, they are not patentably distinct from each other because an ordinary skill in the art would have been motivated to combine the listed claims of copending application to achieve desired outcome.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
None of the claims are allowed.
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/J.A.E./ Examiner, Art Unit 1616
/SUE X LIU/ Supervisory Patent Examiner, Art Unit 1616
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