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 .
Status of Claims
Claims 1 and 3-15 are amended by the applicant. Claim 2 is original. Claim 16 is new. Claims 1-16 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.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 09/01/2023 and 06/27/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Rejections - 35 USC § 112 (a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 3 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 3 encompasses a genus of “derivatives” in regards to starches and cellulose, however, the specification does not disclose a sufficient number of representative species, nor does it describe common structural features sufficient to demonstrate possession of the full scope of the claimed genus. Applicant has support for those particular species of derivatives listed, for example, starch or carboxymethyl cellulose, but does not have full written support for the entire genus that the term “derivatives” would allow for a given compound.
Claim Rejections - 35 USC § 112 (b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2-13 and 15-16 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Independent claim 1 recites an “oral thin” whereas dependent claims 1-13 and 15-16 recite “the oral thin film”. The term “oral thin film” lacks proper antecedent basis in claim 1 because claim 1 does not recite an “oral thin film”, but instead recites only an “oral thin”. As a result, it is unclear whether the dependent claims are limited to a film structure or whether other oral thin structures are encompassed, rendering the scope of the claims indefinite. While applicant may have intended oral “oral thin” and “oral thin film” to be synonymous, claims must be interpreted based on explicit language, and such intent cannot be inferred where the claim language does not provide antecedent basis. Applicant is advised to amend claim 1 to explicitly recite “an oral thin film” if it is the intended subject matter for these dependent claims.
Regarding claim 3, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Applicant is advised to remove the phrase “such as” from the claim.
Claim 3 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 3 recites “derivatives” for starch and cellulose without providing a clear definition of objective boundary as to what structural modifications qualify as a “derivative”. The specification does not sufficiently define the term or set forth criteria by which a person of ordinary skill in the art could determine whether the given compound falls within the scope of the claimed “derivates.” As a result, the scope of the claim is ambiguous, and fails to particularly point out and distinctly claim the subject matter regarded as the invention.
Claims 3, 7, and 13 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claims 3, 7, and 13 recite “selected from the group comprising”. The transitional phrase “comprising” renders the recited group open-ended, thereby making the scope of the claim unclear, as additional unrecited members may be included within the group. When claiming alternative elements selected from a group, the proper transitional phrase is “consisting of” to clearly define the closed set of alternatives. See MPEP 2173.05(h). Accordingly, it is unclear what compounds are encompassed by the claimed “group”, making the metes and bounds of the claim indeterminable with reasonable certainty.
Claim 8 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 8 recites “ketamine, especially preferably (S)-ketamine”., which introduces both a broad genus (ketamine) and a narrower species ((S)-ketamine) within the same claim without clear boundaries. The use of relative and subjective language such as “especially preferably” renders the scope of the claim unclear, as it is uncertain whether the claim is directed to ketamine in general, (S)-ketamine specifically, or both.
Claim 9 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 9 recites “ketamine as a free base and ketamine hydrochloride, preferably (S)-ketamine” as free base and (S)-ketamine hydrochloride., which introduces both a broad genus and a narrower species within the same claim without clear boundaries. The use of relative and subjective language such as “preferably” renders the scope of the claim unclear, as it is uncertain whether the claim is directed to the broader genre or the narrower species.
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.
Claims 1-11, and 13-15 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 Schmiz 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.
Claims 1-3, 5-9, 11 and 13 are provisionally rejected on the ground of nonstatutory 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 and 13 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 and 13-14 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 and 13-14 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 and 14-15 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 and 13 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 and 13 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 and 13-14 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.
Conclusions
No claim is found allowable.
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Arya A. Bazargani, Ph.D.
Patent Examiner
Art Unit 1613
/MARK V STEVENS/Primary Examiner, Art Unit 1613