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 .
Status of Claims
Claims 1, 3, 7-9, and 13 are currently amended. Claim 2 is original. Claims 4-6, 10-12, and 14-16 are previously presented. Claims 17-18 are new. Claims 1-18 are pending and under examination.
Priority
This application is a 371 of PCT/EP2022/055284, filed on March 2, 2022. Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. DE102021105268.8, filed on March 4, 2021. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Rejections Withdrawn
All 35 USC § 112 (a) and (b) rejections imposed in the previous correspondence are withdrawn due to applicant’s amendments.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Rejections maintained in view of amendments: prior arts, prior art mappings, and obviousness statements unchanged. Newly added claims 17 and 18 are now included.
Claims 1-11, 13-15, 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Schmitz et al. (CA3085020A1) in view of Rigas (WO2019067974A1, family member of US11752146B2).
Schmitz et al. discloses a medicinal oral thin film composition containing a cellulose derivative and at least 20% w/w of an active agent, including its manufacturing method and therapeutic use (abstract). Schmitz et al. teaches the oral thin films to contain at least one pharmaceutically active agent that are placed directly in the oral cavity or against the oral mucosa and dissolve there (page 1, paragraph 2). Schmitz et al. teaches that a preferred embodiment of this composition is characterized in that the at least one cellulose derivative comprises a water-soluble and/or water-swellable cellulose derivative (page 2, paragraph 5), which specifically includes hydroxypropyl methyl cellulose (page 3, paragraph 5), which is a polymer. Schmitz et al. teaches that that the at least one cellulose derivative is contained in the oral thin film in an amount of approximately 5% to 80% w/w (page 2, paragraph 6). Schmitz et al. teaches that at least one pharmaceutically active agent in the composition preferably comprises ketamine and/or a pharmaceutically acceptable salt thereof, preferably ketamine-HCI (page 4, paragraph 1) ––ketamine itself is a free base, possesses an amino group, and is used as an antidepressant. Schmitz et al. teaches that (S) ketamine or a pharmaceutically acceptable salt thereof, especially (S) ketamine-HCI, is preferably present as a single stereoisomer of ketamine (page 4, paragraph 2). Schmitz et al. teaches that the at least one pharmaceutically active comprising ketamine or a pharmaceutically acceptable salt thereof is contained in the oral thin film in an amount of at least approximately 20% w/w in relation to the total weight of the oral thin film (page 9, claim 1). Schmitz et al. excludes the addition of acids, bases, and salts in the composition, except the at least one active pharmaceutical ingredient in the form of free acid or base and in the form of a pharmaceutically acceptable salt. Schmitz et al. teaches that this oral film can be used as an antidepressant (page 6, paragraph 3). Schmitz et al. teaches that the composition comprises at least one auxiliary substance selected from the group comprising coloring agents, flavorings, sweeteners, taste-masking agents, emulsifiers, enhancers, pH regulators, humectants, preservatives and/or antioxidants (page 4, paragraph 3), which renders the addition or omission of a buffer (pH regulators) to be an obvious design choice. Schmitz et al. teaches a method for producing the oral thin film comprising the following steps: A) producing an aqueous suspension or solution comprising the at least one cellulose derivative and the at least one pharmaceutically active agent––characterized in that the at least one pharmaceutically active agent comprises ketamine or a pharmaceutically acceptable salt thereof, preferably (S) ketamine or a pharmaceutically acceptable salt thereof, and B) spreading and drying the suspension or solution so that a thin film is obtained (page 5, paragraph 5-9).
However, Schmitz et al. fails to teach the at least one active pharmaceutical ingredient in the form of the free acid or base and the at least one active pharmaceutical ingredient in the form of a pharmaceutically acceptable salt of the free acid or base in a molar ratio of 3:1 to 1:3, and specifically, 1.5:1 to 1:1.5.
Rigas teaches pharmaceutical compositions, methods of making, and methods of using (abstract). Rigas teaches that the pharmaceutical composition may contain an active ingredient or combination of active ingredients (paragraph 55, lines 56-59). Rigas teaches that the molar ratios of two active ingredients in the pharmaceutical composition is in the range from 10:1 to 1:10, preferably from 2.5:1 to 1:2.5, and more preferably about 1:1 (column 58, lines 54-57). Rigas teaches that polymers can be added to the pharmaceutical composition (column 68, line 27). Rigas teaches that the pharmaceutical composition can be suitable for orally dissolving films (column 64, lines 34-35). Rigas teaches compounds and their salts as active ingredients in its disclosure (column 97, claim 1).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to incorporate the teachings of Rigas into the oral thin film compositions of Schmitz et al. This is because Schmitz teaches oral thin films comprising polymeric matrices and pharmaceutically active ingredients that are suitable for administration to the oral cavity, including ketamine and its pharmaceutically acceptable salts. Rigas concurrently teaches pharmaceutical compositions that comprise combinations of active ingredients in defined molar ratios. More specifically, Schmitz teaches oral thin films that comprise of cellulose-based polymers in addition to ketamine (e.g., S-ketamine) or a pharmaceutically acceptable salt thereof, at concentrations that overlap with those recited in the claims. Schmitz additionally teaches methods of preparing such films by forming a solution, spreading, and drying it to create the thin films that are suitable for oral and mucosal administration. Simultaneously, Rigas teaches that pharmaceutical compositions may include combinations of active ingredients in molar ratios that overlap with those claimed, and further teaches that such compositions can be formulated with polymers and are suitable for orally dissolved films. In summary Schmitz provides the oral film platform, polymer matrix, drug loading ranges, method of making, and administration route, while Rigas provides teachings of molar ratios of active agents for the same administration method. A person of ordinary skill in the art would thus have been motivated to combine the teachings of Schmitz and Rigas to optimize formulation characteristics of solubility, dissolution behavior, and delivery performance. Additionally, the claimed molar ratio of free base to salt form falls completely within the ranges taught by Rigas and represents routine optimization of a result-effective variable (modifying ratios/amounts of drugs to optimize treatment). Accordingly, in view of the combined teachings of Schmitz and Rigas, a person of ordinary skills in the art would have had a reasonable expectation of success in arriving at the claimed oral thin film composition in addition to the method of making and administering, which thus renders the claimed invention a predictable variation of prior art.
Claims 12 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Schmitz et al. (CA3085020A1) in view of Rigas (US11752146B2, family member of WO2019067974A1) in further view of Kim et al. (US9694008B2).
Schmitz et al. and Rigas together teach the limitations previously mentioned, including an oral thin film containing at least one polymer matrix, at least one active pharmaceutical ingredient (API) that is acidic or basic, where the API is present as a mixture of its free acid/base form and pharmaceutically acceptable salt form, in a molar ratio overlapping with the range of 3:1 to 1:3, and specifically, 1.5:1 to 1:1.5.
However, Schmitz et al. and Rigas both fail to teach the limitations of claims 13 and 16, which include the pH of the oral thin film ranging from 3.5 to 9.5, and more specifically, 4.5 to 8.8.
Kim et al. discloses an orally fast-dissolving film formulated with aripiprazole (or its pharmaceutically acceptable salt), a film base polymer, and an organic acid, with the pH of the oral film formulation ranging from 4.7 to 6.0. Kim et al. teaches that lowering of the pH with an organic acid promotes dissolution of the active ingredient, promotes secretion of saliva in the mouth, and imparts a sour taste to the film, which allows the taker (or patient) to be less sensitive to the bitterness of the API (paragraph 4, lines 37 to 44).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to incorporate the pH teachings of Kim et al. into the oral thin film compositions of Schmitz et al. as modified by Rigas. This is because Schmitz and Rigas together teach oral thin films comprising a polymer matrix and an active pharmaceutical ingredient present as a mixture of free base and pharmaceutically acceptable salt in defined molar ratios. Kim teaches that oral films adjusted to have a pH range of 4.7 to 6.0 may improve dissolution of the active pharmaceutical ingredient, promotes salivary secretion, and improves palatability. A person of ordinary skill in the art would have thus been motivated to apply the pH-adjusting teachings of Kim to the compositions of Schmitz and Rigas to harness the above benefits and enhance the dissolution of the API in addition to its oral delivery performance. the pH range disclosed by Kim falls within the claimed pH ranges of the present invention, and the application of such pH adjustment techniques to oral thin films would therefore merely have involved routine optimization with a reasonable expectation of success. Even though teachings of Schmitz and Kim have different pharmaceutical compounds, the teachings apply to drug containing oral films.
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.
Double patenting rejections maintained in view of amendments: newly added claims 17 and 18 are now included.
Claims 1-3, 5-9, 11, 13, and 17-18 are provisionally rejected on the ground of non-statutory double patenting as being unpatentable over the following claims of U.S. Patent No. 18/272,405 (referred to as co-pending ‘405): 1 and 5 (for present claims 1, 6-9 and 11); 2 and 10 (for present claim 2); 3 and 11 (for present claim 3); 4 (for present claim 7), 6 (for present claim 13) ––in view of Rigas (WO2019067974A1, family member of US11752146B2).
Each of the above claims (or group of claims) of co-pending ‘405 teach all limitations of their corresponding claim(s) listed in the present application, except for the following difference: the specified molar ratios between the at least one active pharmaceutical ingredient in the form of the free acid or base and the at least one active pharmaceutical ingredient in the form of a pharmaceutically acceptable salt of the free acid or base (specified in claims 1 and 11 of the present application). This difference is not patentably distinct, as the molar ratios between free acid/base and their salt forms represent result-effective variables that would have been routinely optimized by one of ordinary skill in the art in view of Rigas––to improve properties such as dissolution and film performance. Such factors make the above claims of the present application an obvious variation of co-pending ‘405, and thus, patentably indistinct. In regards to claim 5, copending claims do not appear to require other acids, bases, salts and/or buffer systems besides the pharmaceuticals mentioned.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-9, 11, 13, and 17-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the following claims of U.S. Patent No. 18/272,226 (referred to as co-pending ‘226): 1, 5, 7, and 9 (for present claims 1- 4, and 6-9 ); 8 (for present claim 3); and 6 (for present claim 13)––in view of Rigas (WO2019067974A1, family member of US11752146B2).
Each of the above claims (or group of claims) of co-pending ‘226 teach all limitations of their corresponding claim(s) listed in the present application, except for the following difference: the specified molar ratios between the at least one active pharmaceutical ingredient in the form of the free acid or base and the at least one active pharmaceutical ingredient in the form of a pharmaceutically acceptable salt of the free acid or base (specified in claims 1 and 11 of the present application). This difference is not patentably distinct, as the molar ratios between free acid/base and their salt forms represent result-effective variables that would have been routinely optimized by one of ordinary skill in the art in view of Rigas––to improve properties such as dissolution and film performance. Such factors make the above claims of the present application an obvious variation of co-pending ‘226, and thus, patentably indistinct. In regards to claim 5, copending claims do not appear to require other acids, bases, salts and/or buffer systems besides the pharmaceuticals mentioned.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-9, 11, 13-14, and 17-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the following claims of U.S. Patent No. 17/621,147 (referred to as co-pending ‘147): 1, 8, and 15 (for present claims 1, 6, 8, 9); 4 (for claim 2); 5 (for present claim 3); 6 (for present claim 4); and 7 (for present claim 7); 9 (for present claim 13); 10 and 16 (for present claim 14) ––in view of Rigas (WO2019067974A1, family member of US11752146B2).
Each of the above claims (or group of claims) of co-pending ‘147 teach all limitations of their corresponding claim(s) listed in the present application, except for the following difference: the specified molar ratios between the at least one active pharmaceutical ingredient in the form of the free acid or base and the at least one active pharmaceutical ingredient in the form of a pharmaceutically acceptable salt of the free acid or base (specified in claims 1 and 11 of the present application). This difference is not patentably distinct, as the molar ratios between free acid/base and their salt forms represent result-effective variables that would have been routinely optimized by one of ordinary skill in the art in view of Rigas––to improve properties such as dissolution and film performance. Such factors make the above claims of the present application an obvious variation of co-pending ‘147, and thus, patentably indistinct. In regards to claim 5, copending claims do not appear to require other acids, bases, salts and/or buffer systems besides the pharmaceuticals mentioned.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-9, 11, 3-14, and 17-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over the following claims of U.S. Patent No. 16/770,501 (referred to as co-pending ‘501, now issue fee paid): 1 (for present claims 1 and 10); 3 and 4 (for present claim 2); 4 (for present claim 3); 2 (for present claim 4); 7 and 8 (for present claims 6, 7, 8, 9); 9 (for present claim 13); 11 (for present claim 14)––in view of Rigas (WO2019067974A1, family member of US11752146B2).
Each of the above claims (or group of claims) of co-pending ‘501 teach all limitations of their corresponding claim(s) listed in the present application, except for the following difference: the specified molar ratios between the at least one active pharmaceutical ingredient in the form of the free acid or base and the at least one active pharmaceutical ingredient in the form of a pharmaceutically acceptable salt of the free acid or base (specified in claims 1 and 11 of the present application). This difference is not patentably distinct, as the molar ratios between free acid/base and their salt forms represent result-effective variables that would have been routinely optimized by one of ordinary skill in the art in view of Rigas––to improve properties such as dissolution and film performance. Such factors make the above claims of the present application an obvious variation of co-pending ‘501, and thus, patentably indistinct. In regards to claim 5, copending claims do not appear to require other acids, bases, salts and/or buffer systems besides the pharmaceuticals mentioned.
Claims 1-3, 5-9, 10-11, 14-15, and 17-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the following claims of U.S. Patent No. 16/619,359 (referred to as co-pending ‘359: 1 and 9 (for present claims 1 and 6-9); 3 (for present claims 2 and 3); 10 (for present claim 10), 14 (for present claim 14), and 16 (for present claim 15) ––in view of Rigas (WO2019067974A1, family member of US11752146B2).
Each of the above claims (or group of claims) of co-pending ‘359 teach all limitations of their corresponding claim(s) listed in the present application, except for the following difference: the specified molar ratios between the at least one active pharmaceutical ingredient in the form of the free acid or base and the at least one active pharmaceutical ingredient in the form of a pharmaceutically acceptable salt of the free acid or base (specified in claims 1 and 11 of the present application). This difference is not patentably distinct, as the molar ratios between free acid/base and their salt forms represent result-effective variables that would have been routinely optimized by one of ordinary skill in the art in view of Rigas––to improve properties such as dissolution and film performance. Such factors make the above claims of the present application an obvious variation of co-pending ‘359, and thus, patentably indistinct. In regards to claim 5, copending claims do not appear to require other acids, bases, salts and/or buffer systems besides the pharmaceuticals mentioned.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-9, 11, 13, and 17-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the following claims of U.S. Patent No. 18/272,441 (referred to as co-pending ‘441): 1 and 4 (for present claims 1, 6, 7, 8, and 9); 2 (for present claim 2); 3 (for present claim 3); 10 (for present claim 4); and 5 (for present claim 13) ––in view of Rigas (WO2019067974A1, family member of US11752146B2).
Each of the above claims (or group of claims) of co-pending ‘441 teach all limitations of their corresponding claim(s) listed in the present application, except for the following two differences: 1) the at least one active pharmaceutical ingredient is present in the form of a mixture which comprises the at least one active pharmaceutical ingredient both in the form of the free acid or base and in the form of a pharmaceutically acceptable salt, and 2) the specified molar ratios between the at least one active pharmaceutical ingredient in the form of the free acid or base and the at least one active pharmaceutical ingredient in the form of a pharmaceutically acceptable salt of the free acid or base (specified in claims 1 and 11 of the present application). These differences are not patentably distinct, as claim 4 of co-pending ‘441 specifies that at least one active ingredient, preferably (S)-ketamine, is present, and its specification further teaches that (S)-ketamine or a pharmaceutically acceptable salt thereof, especially (S)-ketamine HCl, is especially preferably present (page 2, column 1, paragraph 31). Additionally, the molar ratios between free acid/base and their salt forms represent result-effective variables that would have been routinely optimized by one of ordinary skill in the art in view of Rigas––to improve properties such as dissolution and film performance. Such factors make the above claims of the present application an obvious variation of co-pending ‘441, and thus, patentably indistinct. In regards to claim 5, copending claims do not appear to require other acids, bases, salts and/or buffer systems besides the pharmaceuticals mentioned.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-9, 11, 13, and 17-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the following claims of U.S. Patent No. 18/272,189 (referred to as co-pending ‘189): 1 and 4 (for present claims 1, 6, 7, 8, and 9); 2 (for present claim 2;, 3 (for present claim 3); 8 (for present claim 4); and 5 (for present claim 13) ––in view of Rigas (WO2019067974A1, family member of US11752146B2).
Each of the above claims (or group of claims) of co-pending ‘189 teach all limitations of their corresponding claim(s) listed in the present application, except for the following two differences: 1) the at least one active pharmaceutical ingredient is present in the form of a mixture which comprises the at least one active pharmaceutical ingredient both in the form of the free acid or base and in the form of a pharmaceutically acceptable salt, and 2) the specified molar ratios between the at least one active pharmaceutical ingredient in the form of the free acid or base and the at least one active pharmaceutical ingredient in the form of a pharmaceutically acceptable salt of the free acid or base (specified in claims 1 and 11 of the present application). These differences are not patentably distinct, as claim 4 of co-pending ‘189 specifies that at least one active ingredient, preferably (S)-ketamine, is present, and its specification further teaches that (S)-ketamine or a pharmaceutically acceptable salt thereof, especially (S)-ketamine HCl, is especially preferably present (page 2, column 1, paragraph 28). Additionally, the molar ratios between free acid/base and their salt forms represent result-effective variables that would have been routinely optimized by one of ordinary skill in the art in view of Rigas––to improve properties such as dissolution and film performance. Such factors make the above claims of the present application an obvious variation of co-pending ‘189, and thus, patentably indistinct. In regards to claim 5, copending claims do not appear to require other acids, bases, salts and/or buffer systems besides the pharmaceuticals mentioned.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-3, 5-9, 11, 13-14, and 17-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the following claims of U.S. Patent No. 17/787,874 (referred to as co-pending ‘874): 1 and 11 (for present claims 1, and 6-9); 9 (for present claim 2); 10 (for present claim 3); 12 (for present claim 13); and 13 (for present claim 14) ––in view of Rigas (WO2019067974A1, family member of US11752146B2).
Each of the above claims (or group of claims) of co-pending ‘874 teach all limitations of their corresponding claim(s) listed in the present application, except for the following two differences: 1) the at least one active pharmaceutical ingredient is present in the form of a mixture which comprises the at least one active pharmaceutical ingredient both in the form of the free acid or base and in the form of a pharmaceutically acceptable salt, and 2) the specified molar ratios between the at least one active pharmaceutical ingredient in the form of the free acid or base and the at least one active pharmaceutical ingredient in the form of a pharmaceutically acceptable salt of the free acid or base (specified in claims 1 and 11 of the present application). These differences are not patentably distinct, as claim 11 of co-pending ‘874 specifies that at least one active ingredient, preferably (S)-ketamine, is present, and its specification further teaches that (S)-ketamine or a pharmaceutically acceptable salt thereof, especially (S)-ketamine HCl, is especially preferably present (page 3, column 1, paragraph 53). Additionally, the molar ratios between free acid/base and their salt forms represent result-effective variables that would have been routinely optimized by one of ordinary skill in the art in view of Rigas––to improve properties such as dissolution and film performance. Such factors make the above claims of the present application an obvious variation of co-pending ‘874, and thus, patentably indistinct. In regards to claim 5, copending claims do not appear to require other acids, bases, salts and/or buffer systems besides the pharmaceuticals mentioned.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments filed 05/08/2026 have been fully considered but they are not persuasive.
In response to applicant's arguments against the references individually, one cannot show non-obviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In regards to applicants claim that Rigas “however does not teach a combination of active ingredients comprising the active ingredient in the form of the free acid or base acid in the form of a salt”:
This is unpersuasive because applicant is merely arguing the teachings of Rigas et al. alone without considering Schmitz et al. Specifically, Schmitz et al. teaches that at least one pharmaceutically active agent an oral thin film composition preferably comprises (S)-ketamine and/or a pharmaceutically acceptable salt thereof, preferably (S)-ketamine-HCI (page 4, paragraph 1). Rigas et al. meanwhile teaches that oral film compositions may have at least one active compound or combinations thereof at weight ratios overlapping with those claimed. Therefore, the combined teachings of Rigas et al. and Schmitz et al. would reasonably lead a person of ordinary skill to arrive at the claimed invention.
In regards to applicant’s arguments that “Rigas does not teach or suggest any combination of an active compound and a pharmaceutically acceptable salt thereof”, and “Rigas et al. is silent on combining an active ingredient with a pharmaceutically acceptable salt thereof”, and “examiner has no basis to conclude that the molar ratio disclosed in Rigas et al. (column 58, lines 54 to 57) includes a combination of a pharmaceutically active ingredient and the pharmaceutically acceptable salt thereof.”, and “Rigas provides no motivation to investigate the presently claimed invention”:
These are unpersuasive because once again, applicant is merely relying on the teachings of Rigas et al. alone, While the USC 103 rejection maintained is a combination of Schmitz et al. in view of Rigas et al., wherein Schmitz et al. teaches that at least one pharmaceutically active agent in oral thin film composition preferably comprises (S)-ketamine and/or a pharmaceutically acceptable salt thereof, preferably (S)-ketamine-HCI (page 4, paragraph 1). Rigas et al. is concurrently relied upon for teaching that an active compound or combinations thereof (including active compounds and their salts) may be used in oral film compositions at weight ratios overlapping with those claimed.
In response to applicant’s argument that “Rigas claims and teaches in representative embodiments only compounds of Formula A-D-Y or a pharmaceutically acceptable salt thereof”:
This is unpersuasive because the representative embodiments of Rigas et al. are merely exemplary and non-limiting, and therefore does not teach away other active ingredients such as those in the present claims.
In regards to applicant’s argument that “Rigas et al. fails to teach any advantages of the disclosed molar ratio as it relates to active ingredient and salt thereof”.
This argument is unpersuasive because Rigas et al. discloses that the formulation’s active ingredients such as (S)-ketamine and/or a pharmaceutically acceptable salt thereof disclosed by Schmitz et al. may be in in molar ratios overlapping with those claimed. And adjusting such ratios is a matter of routine optimization for a person of ordinary skill in the art to optimize characteristics such as efficacy of active ingredients, release, and dissolution.
Regarding applicant’s arguments towards the criticality of the pH values of the claimed invention:
Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
These claims of novelty and advantages of such pH ranges for oral films is not supported by any data, as applicant has not referred to such data. Therefore, such claims are merely speculatory.
Regarding applicant’s argument that Kim et al.’s “invention advantageously avoids additional acids or bases in the formulations”:
This is unpersuasive because Kim et al. does not need to teach such acids or bases, as the present claims (i.e., claim 16) merely list the pH range which is already covered by Kim et al. The present claims do not disclose which acid or base is integrated in the composition to arrive at the claimed pH. Furthermore, adjusting such pH values of the composition via acid and/or base is a matter of routine optimization by one of ordinary skill in the art to enhance certain characteristics including taste as taught above by Kim et al. (paragraph 4, lines 37 to 44).
Regarding arguments pointed towards Kim et al. that the taught “combination of the therein disclosed active ingredient with the corresponding salt is neither mentioned nor suggested”, and “Kim et al. does not teach any of the subject matter of claim 1 of the present application”.
Applicant once again is merely arguing against Kim et al.’s individual teachings rather than considering the combined teachings of Schmitz et al. in view of Rigas et al. in further view of Kim et al. These are highly analogous arts, wherein Schmitz et al. provides the claimed active ingredient combinations and their salts, Rigas et al. provides the claimed weight ratios of such active ingredients, and Kim et al. provides the claimed pH range of such formulations. Additionally, Kim et al. does not explicitly teach away any of the claimed components, which indicates that such components are allowed to be integrated in its disclosure.
Regarding applicant’s argument that “claims 12 and 16 is not suggested by Schmitz et al. in combination with Rigas et al. and Kim et al”:
This assertion is incorrect given the teachings of the maintained previously presented USC 103 rejection restated above, which explicitly maps the rejections of claim 12 and 16 over Schmitz et al. in view of Rigas et al. in further view of Kim et al., wherein Kim et al. explicitly teaches pH ranges of such oral thin film compositions to overlap with those presently claimed. Absent proof of unexpected results or criticality, such present claims would have been obvious to an ordinarily skilled artisan in view of the above references.
Regarding applicant’s arguments against the non-statutory double patenting rejections:
These are not persuasive because applicant has failed to show novelty, and Rigas does in fact teach the claimed ratios of the claimed active ingredients. Rigas et al. does not limit the active ingredients to only those stated in its disclosure, which would thus extend to the ratios of the active ingredients stated in the present and co-pending claims.
Conclusions
No claim is found allowable.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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Arya A. Bazargani, Ph.D.
Patent Examiner
Art Unit 1613
/MARK V STEVENS/ Primary Examiner, Art Unit 1613
Prosecution Insights