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 .
Formal Matters
Receipt of Applicant’s response dated 02/23/2026 is acknowledged.
Claims 1-17 and 19-21 are pending.
Claim 18 is canceled.
Claims 1-5, 8-11, and 13-15 are amended.
Claims 16-17 and 19 remain withdrawn from consideration as being drawn to a nonelected invention.
Claims 1-15 and 20-21 are under consideration in the instant Office action to the extent of the elected species, i.e., the first and/or the second matrix layer comprises polyvinyl alcohol and tris(hydroxymethyl)aminomethane as the at least one polymer, ketamine as the at least one pharmaceutically active agent, and a taste-masking agent as the least one auxiliary substance.
Information Disclosure Statement
The information disclosure statement (IDS) filed 12/18/2025 has been considered by the Examiner. A signed copy of the IDS is included with the present Office Action.
OBJECTIONS/REJECTIONS WITHDRAWN
Specification
The objection to the specification set forth in the Office action dated 10/23/2025 is hereby withdrawn in light of Applicant’s amendments to the specification.
Claim Objections
The objections to claims 5, 10-11, and 15 set forth in the Office action dated 10/23/2025 are hereby withdrawn in light of Applicant’s amendments to the claims.
Claim Rejections - 35 USC § 112
The indefiniteness rejections (a)-(i) and (k) set forth in the Office action dated 10/23/2025 are hereby withdrawn in light of Applicant’s amendments to the claims.
REJECTIONS MAINTAINED AND MADE AGAIN
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 10 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 10 recites the limitation “the water-soluble polymer” spanning lines 1-2. There is insufficient antecedent basis for this limitation in the claim because none of claim 10, claim 9, or claim 1 earlier recite ‘a water-soluble polymer’, but instead claim 9 recites ‘at least one water-soluble polymer’ which encompasses multiple water-soluble polymers and, therefore, it is unclear whether just one, more than one or all of the water-soluble polymers are being referenced. The Examiner suggests amending ‘the water-soluble polymer’ in claim 10 to ‘the at least one water-soluble polymer’ in order to overcome this rejection.
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.
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 1-3, 5-11, and 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Bauer et al (DE 102017127434 A1, published 05/23/2019, cited in IDS dated 07/14/2023, English translation cited in Notice of References Cited dated 07/30/2025) in view of Tagliferri et al (WO 2009/124096 A1, published 10/08/2009, cited in IDS dated 07/14/2023).
Bauer et al teach a multi-layered oral dosage form comprising a first film layer and a second film layer, wherein the oral dosage form may be of thin shape, and wherein the oral dosage form comprises a water-soluble polymer, an active ingredient, and optionally excipients such as a taste-masking agent and a pH regulator (See entire document, e.g., Abstract, Page 3 Last Par. and Page 4 Par. 6 of English translation).
A suitable adhesive may be introduced into the space between the first film layer and second film layer securing the layers together, wherein the suitable adhesive is based on at least one water-soluble polymer, e.g., polyethylene glycol copolymer, and at least one plasticizer, e.g., polyethylene glycol (e.g., Page 3 Par. 7 and 9 of English translation).
The first film layer composition may be identical to the second film layer and comprises a water-soluble polymer (e.g., Abstract). The water-soluble polymer should be a pharmaceutically acceptable material, wherein the most preferred water-soluble polymer is polyvinyl alcohol (e.g., Page 4 Par. 2 of English translation). The active ingredient may be any orally administrable active ingredient with pharmaceutical active ingredients being preferred, e.g., antiallergic agents, antiarrhythmic agents, antibiotics, antidiabetic agents, anti-epileptic agents, antihistamines, antitussives, cardiotronic agents, diuretics, antihypertensive agents, narcotics, nerve muscle blockers and sex hormones (e.g., Page 4 Par. 4 of English translation). The taste-masking agent may be present as part of the first film layer and/or the second film layer, or in the cavity of the dosage form (e.g., Page 4 Par. 6 and Last Par. of English translation).
The proportion of water-soluble polymer in the first film layer and second film layer is usually about 85 to about 100 wt.%, however in the case of the presence of a taste-masking agent, the proportion of water-soluble polymer in the first film layer and in the second film layer may be lower than stated above, but should still be in the range of about 15 to about 75 wt.% (e.g., Page 4 Par. 3 of English translation).
The first film layer and/or the second film layer may be formulated as a foam, i.e. contain an introduced gas, such as air, nitrogen or CO2, or another gas (e.g., Page 5 Par. 4 of English translation).
Bauer et al do not teach the pH regulator being tris(hydroxymethyl)aminomethane.
This deficiency is made up for in the teaching of Tagliferri et al.
Tagliferri et al teach a patch for delivery of permeants through a biological membrane of a subject, e.g., oral mucosal membrane, wherein the patch comprises a polymer matrix, at least one hydrophilic permeant and at least one permeability enhancer disposed within the matrix, wherein at least a portion of the permeant can dissolve in biological moisture received from the subject (See entire document, e.g., Abstract, Page 2 Lines 21-26, Page 12 Line 34-Page 13 Line 1). The at least one hydrophilic permeant may be a bioactive agent and the at least one permeability enhancer may be a pH control agent selected from a list including tris (i.e., abbreviation for tris(hydroxymethyl)aminomethane; e.g., Page 2 Lines 27-28 and 32-35). The polymer matrix may contain a single polymer, e.g., a water-soluble polymer being polyvinyl alcohol (e.g., Page 3 Lines 1-5). The pH control agent can be present in any amount capable of achieving a desired level of pH control, e.g., from approximately 1 to approximately 99 wt.% of the total patch weight (e.g., Page 30 Lines 14-17).
It would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, based on the teachings of Bauer et al and Tagliferri et al, to provide a multi-layered, thin-shaped oral dosage form comprising a first film layer, a second film layer, and an active ingredient, wherein the layers are secured together by an adhesive layer made of polyethylene glycol copolymer and polyethylene glycol, wherein the first film layer composition may be identical to the second film layer and comprises tris(hydroxymethyl)aminomethane from 1 to approximately 99 wt.% disposed within a matrix of a water-soluble polymer being polyvinyl alcohol present from 15 to about 75 wt.%, with respect to the layer, and also comprises a taste-masking agent, wherein the first film layer and/or the second film layer may be formulated as a foam, i.e. contain an introduced gas, such as air, nitrogen or CO2, or another gas.
One of ordinary skill in the art would have been motivated to use tris(hydroxymethyl)aminomethane as the pH regulator in the oral dosage form of Bauer et al in order to provide an oral dosage form with enhanced permeability to the oral mucosal membrane. There would have been a reasonable expectation of success in using tris(hydroxymethyl)aminomethane as the pH regulator in the oral dosage form of Bauer et al because Bauer et al teach the compatibility of the oral dosage form with pH regulators and Tagliferri et al teach use of tris(hydroxymethyl)aminomethane as a pH control agent disposed within a polymer matrix containing polyvinyl alcohol for dissolution in the oral mucosal membrane.
The oral dosage form of Bauer et al in view of Tagliferri et al render obvious claims 1-3, 5-11, and 20-21.
The adhesive layer made of polyethylene glycol copolymer and polyethylene glycol (i.e., the adhesive layer comprises 100% polyethylene glycol copolymer and polyethylene glycol) between the first film layer and the second film layer in the oral dosage form of Bauer et al in view of Tagliferri et al renders obvious the limitation of the instant claims of a separation layer (i.e., ‘separation layer’ of the instant claims is synonymous with ‘adhesive layer’ as evidenced by Page 3 of the Specification) located between the first and second layers comprising at least one polyethylene glycol in an amount of from 60 to 100 wt.% (instant claim 1) and in an amount of from 80 to 100 wt.% (instant claim 8). Suitable adhesives being polyethylene glycol copolymer and polyethylene glycol, neither of which restricted to a particular molecular weight range or viscosity range, renders obvious the limitation that the separation layer comprises at least one polyethylene glycol with a molecular weight from 8,000 g/mol to 7,000,000 g/mol (instant claim 1), a molecular weight of from 8,000 g/mol to 300,000 g/mol (instant claim 6), a molecular weight of 100,000 g/mol or of about 200,000 g/mol (instant claim 20), a molecular weight of from 95,000 g/mol to 105,000 g/mol or from 195,000 g/mol to 205,000 g/mol (instant claim 21), and a viscosity of from 30 mPa s to 50 mPa s measured in 5 wt.% aqueous solution at 25 degrees Celsius (instant claim 7).
The film layer composition comprising tris(hydroxymethyl)aminomethane from 1 to approximately 99 wt.% disposed within a matrix of a water-soluble polymer being polyvinyl alcohol present from 15 to about 75 wt.%, with respect to the layer, in the oral dosage form of Bauer et al in view of Tagliferri et al renders obvious the ranges of instant claims 10-11. A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art (In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003)).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Bauer et al (as cited above) in view of Tagliferri et al (as cited above) as applied to claims 1-3, 5-11, and 20-21 above, and further in view of Nivorozhkin et al (US 2016/0199304 A1, published 07/14/2016, cited in Notice of References Cited dated 10/23/2025).
The oral dosage form of Bauer et al in view of Tagliferri et al has been discussed supra.
Neither Bauer et al nor Tagliferri et al teach the active ingredient being ketamine.
This deficiency is made up for in the teaching of Nivorozhkin et al.
Nivorozhkin et al teach oral neuro-attenuating ketamine tablet formulations which ensure the steady release of a therapeutically effective concentration of ketamine from an oral tablet without neurologically toxic spikes in ketamine concentration (See entire document, e.g., Abstract). Nivorozhkin et al teach that ketamine is a non-selective NMDA receptor antagonist approved by the FDA for induction and maintenance of general anesthesia, and has also been shown effective in treating other conditions, e.g., to alleviate different kinds of pain, depression, acute brain injury and stroke, epilepsy, alcohol dependence, Alzheimer’s disease, asthma, and other disorders (e.g., [0002]).
It would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, based on the teachings of Bauer et al, Tagliferri et al, and Nivorozhkin et al, to use ketamine as the active ingredient in the oral dosage form of Bauer et al in view of Tagliferri et al, discussed supra. One of ordinary skill in the art would have been motivated to do so in order to provide an oral dosage form with anesthetic properties and/or for treating conditions, e.g., to alleviate different kinds of pain, depression, acute brain injury and stroke, epilepsy, alcohol dependence, Alzheimer’s disease, asthma, and other disorders, and there would have been a reasonable expectation of success because Bauer et al teach that the active ingredient may be any orally administrable active ingredient wherein pharmaceutical active ingredients are preferred, e.g., antiallergic agents, antiarrhythmic agents, antibiotics, antidiabetic agents, anti-epileptic agents, antihistamines, antitussives, cardiotronic agents, diuretics, antihypertensive agents, narcotics, nerve muscle blockers and sex hormones, and Nivorozhkin et al teach use of ketamine in an oral tablet for treating the aforementioned conditions.
Claims 12-15 are rejected under 35 U.S.C. 103 as being unpatentable over Bauer et al (as cited above) in view of Tagliferri et al (as cited above) as applied to claims 1-3, 5-11, and 20-21 above, and further in view of Müller et al (WO 2018/224591 A1, published 12/13/2018, cited in Notice of References Cited dated 10/23/2025).
The oral dosage form of Bauer et al in view of Tagliferri et al has been discussed supra.
Although the first film layer and/or the second film layer of the oral dosage form of Bauer et al in view of Tagliferri et al may be formulated as a foam, i.e. contain an introduced gas, such as air, nitrogen or CO2, or another gas, neither Bauer et al nor Tagliferri et al teach the foam being a solidified foam having voids, that the voids are isolated from one another and are preferably present in the form of bubbles, wherein the voids are filled with air or a gas, preferably with an inert gas, especially preferably with nitrogen, carbon dioxide, helium or a mixture of at least two of the gases, that the voids are connected to one another an preferably form a channel system penetrating the particular matrix layer, or that the voids in the particular matrix layer have a volume fraction of from 5 to 98%, preferably from 50 to 80%, in relation to the total volume of the particular matrix layer.
These deficiencies are made up for in the teaching of Müller et al.
Müller et al teach flat dosage forms that disintegrate or dissolve in an aqueous environment for releasing at least one active ingredient in a body orifice or body cavity, and which are formed from a polymer matrix in the form of a solidified foam having cavities, and at least one pharmaceutical active ingredient, and which have a high mass per unit area in the region of 50 to 350 g/m² with substantially improved mouthfeel in comparison to conventional film dosage forms (See entire document, e.g., Abstract). Polyvinyl alcohol is the most preferred polymer for the polymer matrix (e.g., Middle of Page 3 of English translation). The cavities in the dosage form can be isolated from one another in the polymer matrix, preferably in the form of solidified bubbles, or the cavities in the dosage form can be in communication with one another, preferably forming a continuous channel system that penetrates the matrix. The cavities are preferably filled with gas or a gas mixture, such as air, nitrogen, carbon dioxide, and helium, as well as a mixture or plurality of these gases. The cavities have a volume fraction of 5 to 98%, preferably of 50 to 80%, based on the total volume of the dosage form (e.g., Bottom of Page 3 of English translation).
It would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, based on the teachings of Bauer et al, Tagliferri et al, and Müller et al, to provide the oral dosage form wherein the film layers comprise a polymer matrix containing the water-soluble polymer in the form of a solidified foam having cavities, wherein the cavities can be isolated from one another in the form of solidified bubbles or wherein the cavities are connected forming a continuous channel system that penetrates the matrix, wherein the cavities are filled with gas or a gas mixture, such as air, nitrogen, carbon dioxide, helium, or a mixture or plurality of these gases, and wherein the cavities have a volume fraction of 5 to 98% based on the total volume of the dosage form. One of ordinary skill in the art would have been motivated to do so because Müller et al teach this form as having improved mouthfeel and teach the compatibility with ketamine as active ingredient (e.g., Middle of Page 4 of English translation). There would have been a reasonable expectation of success because the first film layer and/or the second film layer of the oral dosage form of Bauer et al in view of Tagliferri et al may be formulated as a foam, i.e. contain an introduced gas, such as air, nitrogen or CO2, or another gas.
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 1-15 and 20-21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 and 11-14 of copending Application No. 18/272,189 (hereafter ‘189) in view of Bauer et al (as cited above) and Tagliferri et al (as cited above).
This is a provisional nonstatutory double patenting rejection.
Claim 1 of ‘189 recites a multi-layer oral thin film comprising a matrix layer, which contains at least one polymer and at least one pharmaceutically active agent, and at least one backing layer, wherein the at least one backing layer comprises at least one polyethylene glycol in an amount of from 60 to 100 wt. %. in relation to the total weight of the at least one backing layer. Claim 2 of ‘189 recites the matrix layer comprises at least one water-soluble polymer. Claim 3 of ‘189 recites the at least one water-soluble polymer is selected from the group comprising starch and starch derivatives, dextrans, cellulose derivatives, such as carboxymethyl cellulose, hydroxypropyl cellulose, hydroxyethyl cellulose, hydroxypropyl methylcellulose, hydroxypropyl ethyl cellulose, sodium carboxymethyl cellulose, ethyl or propyl cellulose, polyacrylic acids, polyacrylates, polyvinylpyrrolidones, vinyl pyrrolidone/vinyl acetate copolymers, polyvinyl alcohols, polyethylene oxide polymers, polyacrylamides, polyethylene glycols, gelatines, collagen, alginates, pectin, pullulan, tragacanth, chitosan, alginic acid, arabinogalactan, galactomannan, agar, agarose, carrageenan, and natural gums. Claim 4 of ‘189 recites the at least one pharmaceutically active agent is selected from the group comprising the active agent classes of analgesics, hormones, hypnotics, sedatives, antiepiletics, analeptics, psychoneurotropic drugs, neuro-muscle blockers, antspasmodics, antihistamines, antiallergics, cardiotonics, antiarrhythmics, diuretics, hypotensives, vasopressors, antidepressants, antitussives, expectorants, thyroid hormones, sexual hormones, antidiabetics, antitumour active agents, antibiotics, chemotherapeutics and narcotics, wherein the at least one pharmaceutically active agent preferably comprises ketamine, especially preferably (S)-ketamine. Claim 5 of ‘189 recites the matrix layer further comprises at least one auxiliary substance selected from the group comprising colouring agents, flavourings, sweeteners, plasticisers, taste-masking agents, emulsifiers, enhancers, pH regulators, humectants, preservatives and/or antioxidants. Claim 6 of ‘189 recites the at least one polyethylene glycol has a mean molecular weight of from 20,000 g/mol to 7,000,000 g/mol, preferably from 40,000 g/mol to 500,000 g/mol, especially preferably from 95,000 g/mol to 105,000 g/mol, especially of about 100,000 g/mol. Claim 7 of ‘189 recites the at least one polyethylene glycol has a viscosity of from 30 mPa s to 50 mPa s, measured in 5 wt. % aqueous solution at 25° C. Claim 8 of ‘189 recites the at least one polyethylene glycol is preferably contained in the at least one backing layer in an amount of from 60 to 100 wt. %, preferably in an amount of from 80 to 100 wt. %, in relation to the total weight of the at least one backing layer. Claim 11 of ‘189 recites the matrix layer is present in the form of a solidified foam that has voids. Claim 12 of ‘189 recites the voids are isolated from one another and are preferably present in the form of bubbles, wherein the voids are filled with air or a gas, preferably with an inert gas, especially preferably with nitrogen, carbon dioxide, helium or a mixture of at least two of these gases. Claim 13 of ‘189 recites the voids are connected to one another and preferably form a channel system penetrating the matrix layer. Claim 14 of ‘189 recites the voids in the matrix layer account for a volume fraction of from 5 to 98%, preferably from 50 to 80%, in relation to the total volume of the layer in question.
The claims of ‘189 do not recite the oral thin film comprising two matrix layers and do not recite the at least one water-soluble polymer being polyvinyl alcohol and tris(hydroxymethyl)aminomethane nor their amounts.
These deficiencies are made up for in the teachings of Bauer et al and Tagliferri et al, which has been discussed supra.
It would have been prima facie obvious to one of ordinary skill in the art, based on the teachings of Bauer et al and Tagliferri et al, to provide the oral thin film of the claims of ‘189 comprising a first film layer and a second film layer, wherein the backing layer is located between the first and second film layers, wherein the first film layer composition may be identical to the second film layer and comprises tris(hydroxymethyl)aminomethane from 1 to approximately 99 wt.% disposed within a matrix of a water-soluble polymer being polyvinyl alcohol present from 15 to about 75 wt.%, with respect to the layer.
Thus, instant claims 1-15 and 20-21 are not patentably distinct from the oral thin film of claims 1-8 and 11-14 of ‘189 in view of Bauer et al and Tagliferri et al.
Claims 1-15 and 20-21 are directed to an invention not patentably distinct from claims 1-8 and 11-14 of commonly assigned U.S. copending Application No. 18/272,189. Specifically, see above.
The U.S. Patent and Trademark Office may not institute a derivation proceeding in the absence of a timely filed petition. The USPTO normally will not institute a derivation proceeding between applications or a patent and an application having common ownership (see 37 CFR 42.411 ). Commonly assigned U.S. copending Application No. 18/272,189, discussed above, may form the basis for a rejection of the noted claims under 35 U.S.C. 102 or 103 if the commonly assigned case qualifies as prior art under 35 U.S.C. 102(a)(2) and the patentably indistinct inventions were not commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention.
In order for the examiner to resolve this issue the applicant or patent owner can provide a statement under 35 U.S.C. 102(b)(2)(C) and 37 CFR 1.104(c)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the applicant or patent owner can provide a statement under 35 U.S.C. 102(c) and 37 CFR 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
A showing that the inventions were commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention will preclude a rejection under 35 U.S.C. 102 or 103 based upon the commonly assigned case. Alternatively, applicant may take action to amend or cancel claims such that the applications, or the patent and the application, no longer contain claims directed to patentably indistinct inventions.
Claims 1-15 and 20-21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 and 17-19 of copending Application No. 18/272,226 (hereafter ‘286) in view of Bauer et al (as cited above).
This is a provisional nonstatutory double patenting rejection.
Claim 1 of ‘226 recites an oral thin film, comprising at least one layer, which contains at least one polyvinyl alcohol and tris(hydroxymethyl)aminomethane in an amount of from 15 to 70 wt. % in relation to the total weight of the at least one layer. Claim 2 of ‘226 recites that polyvinyl alcohol is contained in the at least one layer in an amount of from 20 to 90 wt. % in relation to the total weight of the at least one layer. Claim 3 of ‘226 recites that tris(hydroxymethyl)aminomethane is contained in the at least one layer in an amount of from 25 to 55 wt. % in relation to the total weight of the at least one layer. Claims 4-5 of ‘226 recite the at least one layer comprises at least one pharmaceutically active agent selected from the group comprising the active agent classes of analgesics, hormones, hypnotics, sedatives, antiepiletics, analeptics, psychoneurotropic drugs, neuro-muscle blockers, antspasmodics, antihistamines, antiallergics, cardiotonics, antiarrhythmics, diuretics, hypotensives, vasopressors, antidepressants, antitussives, expectorants, thyroid hormones, sexual hormones, antidiabetics, antitumour active agents, antibiotics, chemotherapeutics and narcotics, the at least one pharmaceutically active agent preferably comprising ketamine, especially preferably (S)-ketamine, or pharmaceutically acceptable salts thereof. Claim 6 of ‘226 recites the at least one layer comprises at least one auxiliary substance selected from the group comprising colouring agents, flavourings, sweeteners, plasticisers, taste-masking agents, emulsifiers, enhancers, humectants, an acid or a base (or a salt thereof), preservatives and/or antioxidants. Claims 7-9 of ‘226 recite the oral thin film has at least one further layer which comprises at least one matrix polymer and at least one pharmaceutically active agent, wherein the at least one polymer is a water-soluble polymer which is selected from the group comprising starch and starch derivatives, dextrans, cellulose derivatives, such as carboxymethyl cellulose, hydroxypropyl cellulose, hydroxyethyl cellulose, hydroxypropyl methylcellulose, hydroxypropyl ethyl cellulose, sodium carboxymethyl cellulose, ethyl or propyl cellulose, polyacrylic acids, polyacrylates, polyvinylpyrrolidones, vinyl pyrrolidone/vinyl acetate copolymers, polyvinyl alcohols, polyethylene oxide polymers, polyacrylamides, polyethylene glycols, gelatines, collagen, alginates, pectin, pullulan, tragacanth, chitosan, alginic acid, arabinogalactan, galactomannan, agar, agarose, carrageenan, and natural gums and the at least one pharmaceutically active agent is selected from the group comprising the active agent classes of analgesics, hormones, hypnotics, sedatives, antiepiletics, analeptics, psychoneurotropic drugs, neuro-muscle blockers, antspasmodics, antihistamines, antiallergics, cardiotonics, antiarrhythmics, diuretics, hypotensives, vasopressors, antidepressants, antitussives, expectorants, thyroid hormones, sexual hormones, antidiabetics, antitumour active agents, antibiotics, chemotherapeutics and narcotics, the at least one pharmaceutically active agent preferably comprising ketamine, especially preferably (S)-ketamine, or pharmaceutically acceptable salts thereof. Claim 10 of ‘226 recites the at least one layer which contains at least one polyvinyl alcohol and tris(hydroxymethyl)aminomethane, and/or the at least one further layer which comprises at least one matrix polymer and at least one pharmaceutically active agent is present in the form of a solidified foam having voids. Claim 11 of ‘226 recites the voids are isolated from one another and are preferably present in the form of bubbles, the voids being filled with air or a gas, preferably with an inert gas, especially preferably with nitrogen, carbon dioxide, helium or a mixture of at least two of these gases. Claim 12 of ‘226 recites the voids are connected to one another and preferably form a channel system penetrating the matrix layer. Claim 13 of ‘226 recites the voids account for a volume fraction of from 5 to 98%, in relation to the total volume of the layer in question. Claims 17-18 of ‘226 recite the voids are present in the form of bubbles filled with nitrogen, carbon dioxide, helium or a mixture of at least two of these gases. Claim 19 of ‘226 recites the voids account for a volume fraction from 50 to 80%, in relation to the total volume of the layer in question. Claim 14 of ‘226 recites the at least one layer which contains at least one polyvinyl alcohol and tris(hydroxymethyl)aminomethane, and/or the at least one further layer which comprises at least one matrix polymer and at least one pharmaceutically active agent are laminated directly onto one another or are connected to one another by an intermediate adhesive layer or separation layer.
The claims of ‘226 do not teach what the intermediate adhesive layer or separation comprises.
This deficiency is made up for in the teaching of Bauer et al, which has been discussed supra.
It would have been prima facie obvious to one of ordinary skill in the art, based on the teaching of Bauer et al, to provide the oral thin film of the claims of ‘226 wherein the intermediate adhesive layer or separation layer is made of at least one water-soluble polymer being polyethylene glycol copolymer and at least one plasticizer being polyethylene glycol (i.e., the intermediate adhesive layer or separation layer comprises 100% polyethylene glycol copolymer and polyethylene glycol).
Thus, instant claims 1-15 and 20-21 are not patentably distinct from the oral thin film of claims 1-14 and 17-19 of ‘226 in view of Bauer et al.
Claims 1-15 and 20-21 are directed to an invention not patentably distinct from claims 1-14 and 17-19 of commonly assigned U.S. copending Application No. 18/272,226. Specifically, see above.
The U.S. Patent and Trademark Office may not institute a derivation proceeding in the absence of a timely filed petition. The USPTO normally will not institute a derivation proceeding between applications or a patent and an application having common ownership (see 37 CFR 42.411 ). Commonly assigned U.S. copending Application No. 18/272,226, discussed above, may form the basis for a rejection of the noted claims under 35 U.S.C. 102 or 103 if the commonly assigned case qualifies as prior art under 35 U.S.C. 102(a)(2) and the patentably indistinct inventions were not commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention.
In order for the examiner to resolve this issue the applicant or patent owner can provide a statement under 35 U.S.C. 102(b)(2)(C) and 37 CFR 1.104(c)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the applicant or patent owner can provide a statement under 35 U.S.C. 102(c) and 37 CFR 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
A showing that the inventions were commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention will preclude a rejection under 35 U.S.C. 102 or 103 based upon the commonly assigned case. Alternatively, applicant may take action to amend or cancel claims such that the applications, or the patent and the application, no longer contain claims directed to patentably indistinct inventions.
Response to Applicant’s Arguments
Applicant’s arguments filed on 02/23/2026 have been considered.
Regarding the above maintained rejection under 35 USC 112, in Remarks dated 02/23/2026, Applicant states that they have revised the claims to address the Examiner’s concerns regarding the rejections under 35 USC 112, however, neither in Remarks nor in the claim amendments is the rejection denoted as (j) set forth in the Office action dated 10/23/2025 addressed. For this reason, the above rejection under 35 USC 112 is hereby maintained.
Regarding the prior art rejections under 35 USC 103, Applicant argues that Bauer teaches a dosage form as a pouch, and given this configuration, the use of a separation layer is illogical as this would prevent the formation of a pouch that can be filled with an active ingredient, and moreover, the skilled artisan would not find any motivation to add a separation layer to the dosage form of Bauer. Applicant argues that while Bauer describes the use of a water-soluble polymer and mentions polyethylene glycol as one possible option for a water-soluble polymer, there is no disclosure of polyethylene glycol with a molecular weight from 8,000 g/mol to 7,000,000 g/mol in an amount of from 60 to 100 wt.% in relation to the total weight of the separation layer. Applicant argues that Tagliferri discloses polyethylene glycol as one of water-soluble polymers suitable for use in the matrix layer of the oral thin film, and therefore, there is no suggestion to use a water-soluble polymer such as PEG, which is only mentioned as one of several possible polymers, in the separation layer of an oral thin film. Applicant argues that Bauer and Tagliferri neither disclose nor suggest alone or in combination the use of polyethylene glycol with a molecular weight from 8,000 g/mol to 7,000,000 g/mol in an amount of from 60 to 100 wt.% in relation to the total weight of the separation layer as a water-soluble polymer in a separation layer of a multilayer oral thin film.
The above arguments have been fully considered by the Examiner but are not found persuasive because, firstly, the rejection of claims 1-3, 5-11, and 20-21 under 35 USC 103 does not rely on the stance that it would have been obvious to add a separation layer to the dosage form of Bauer et al as argued by Applicant, but rather the rejection relies on the stance that the adhesive layer of the oral dosage form of Bauer et al in view of Tagliferri et al renders obvious the limitation of the separation layer of instant claim 1 (See the maintained rejection above for more details). Further, the adhesive layer being made of polyethylene glycol copolymer and polyethylene glycol (i.e., the adhesive layer comprises 100% polyethylene glycol copolymer and polyethylene glycol), wherein neither polyethylene glycol copolymer and polyethylene glycol are restricted to a particular molecular weight range, located between the first film layer and the second film layer in the oral dosage form of Bauer et al in view of Tagliferri et al renders obvious the claimed limitation of the separation layer comprising at least one polyethylene glycol with a molecular weight from 8,000 g/mol to 7,000,000 g/mol in an amount of from 60 to 100 wt.% in relation to the total weight of the separation layer (See the maintained rejection above for more details). The above arguments regarding the teaching of Tagliferri et al have been fully considered by the Examiner but are not found persuasive because the rejection relies on the teaching of Tagliferri et al to cure the deficiency in the teaching of Bauer et al, i.e. the pH regulator being tris(hydroxymethyl)aminomethane, and the rejection does not rely on the teaching of Tagliferri et al for using a water-soluble polymer such as PEG in the separation layer of an oral thin film as argued by Applicant. The above argument regarding what each of Bauer et al and Tagliferri et al disclose or suggest alone is not found persuasive because the rejection of claims 1-3, 5-11, and 20-21 under 35 USC 103 is based on the combined teachings of Bauer et al and Tagliferri et al, not their individual teachings. Applicant is reminded that the reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006). As is discussed in detail in the maintained grounds of rejection above, the oral dosage form of Bauer et al in view of Tagliferri et al meets all of the limitations of instant claims 1-3, 5-11, and 20-21, and for at least the reasons described herein, the above rejections under 35 USC 103 are hereby maintained.
Regarding the provisional rejections on the ground of nonstatutory double patenting, Applicant argues again that Bauer does not teach or suggest a separation layer.
The above argument has been fully considered by the Examiner but is not found persuasive because, as discussed above, the oral dosage form of Bauer et al in view of Tagliferri et al meets all of the limitations of instant claims 1-3, 5-11, and 20-21, including the claimed separation layer, and for at least the reasons described herein, the rejections on the ground of nonstatutory double patenting are hereby maintained.
Conclusion
No claims are allowable.
THIS ACTION IS MADE FINAL. 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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/K.E.O./Examiner, Art Unit 1619
/DAVID J BLANCHARD/Supervisory Patent Examiner, Art Unit 1619
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