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 .
Election/Restrictions
Applicant’s election without traverse of Group I invention in the reply filed on 04/16/2026 is acknowledged. Accordingly, claim 20 has been withdrawn.
Information Disclosure Statement
The information disclosure statement (IDS) was submitted on 06/21/2024 The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 102
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-7, is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Berdahl et al. (US 10166240 B2, cited in IDS, hereinafter “Berdahl’240”) as evidenced by EIN Presswire publication (“Melt Pharmaceuticals Improves Patent Estate for Sublingual Non-Opioid Pain and Sedation Formulations, February 13, 2019).
Regarding claims 1-3 and 6-7,
Berdahl’240 teaches or suggests a method of inducing conscious sedation or pre-sedation by administering a composition comprising a benzodiazepine-based compound such as midazolam and a NMDA antagonist such as ketamine, and optionally a beta-blocker, antiemetic, an NSAID and/or an antihistamine medication (entire documents; abstract; col. 5, line 60 through col. 7, line 3; col. 11, lines 2-28; col. 12, lines 60-67; claims 1, 9-10 and 19) wherein said composition can be delivered in various dosage form including sublingually (col. 1, lines 26-34 and col. 2, lines 32-36; col. 3, lines 56-62; col. 11, lines 42-44). The reference discloses that the term “conscious sedation” is used interchangeably with the terms “procedural sedation” and “analgesia” (col. 3, lines 40-47) and that the “pre-sedation” as conscious sedation is induced sedation sometime before the procedure e.g., between 5 minutes and 1 hour prior (col.3, lines 65-67). Table 5 shows a composition comprising midazolam, ketamine and propranolol where ratios of midazolam:ketamine:propranolol are between about 1:2:1, 1:10:1, 1:4:1, 1:6:1 or 1:5:1 (see also claims 9 and 10). Furthermore, the reference discloses exemplary composition comprising midazolam, ketamine and ondansentron in ratio of 3:25:2 (col. 11, lines 21-29). As the specific embodiment, the reference discloses a troche comprising about 0.2g of midazolam, about 2.0g of ketamine and 0.2g of propranolol or ondansetron (Example 1).
EIN presswire is cited as a reference to demonstrate that the composition described in the Berdahl’240 is delivered as a sublingual form (see page 2). The publication makes reference to the instant US patent number 10166240 and related application 10179136.
Regarding claim 4, whether language recited in a “wherein” clause constitutes a claim limitation depends on the specific facts of the case. In the present case, the claim recites that “the level of sedation achieved is measured via the Ramsay sedation scale.” Because this measurement step does not affect the sedation achieved by the administration of a pharmaceutical composition within the same or a similar claimed range, the Examiner determines that this step is non-limiting and is not accorded patentable weight. Accordingly, the reference anticipates the claimed invention. Assuming, arguendo, that the reference does not anticipate the claim, the determination of the level of sedation measured by the Ramsay sedation scale would nevertheless have been obvious under 35 U.S.C. § 103, as explained below.
Regarding claim 5, whether language recited in a “wherein” clause constitutes a claim limitation depends on the specific facts of the case. In the present case, the claim recites that “the level of sedation is achieved is greater than a level of sedation achieved by administering midazolam alone or ketamine alone.” Because this recitation simply expresses the intended result of a process step positively recited by the administration of a pharmaceutical composition within the same or a similar claimed range, the Examiner determines that this recitation is non-limiting and is not accorded patentable weight. Accordingly, the reference anticipates the claimed invention.
Claim(s) 1-7, is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Berdahl et al. (US 10391102 B2, cited in IDS, hereinafter “Berdahl’102”) as evidenced by EIN Presswire publication (“Melt Pharmaceuticals Improves Patent Estate for Sublingual Non-Opioid Pain and Sedation Formulations, February 13, 2019).
Regarding claims 1-3 and 6-7,
Similarly as discussed above, Berdahl’102 teaches or suggests a method of inducing conscious sedation ore pre-sedation by administering a composition comprising a benzodiazepine-based compound such as midazolam and a NMDA antagonist such as ketamine, and optionally a beta-blocker, antiemetic, an NSAID and/or an antihistamine medication (entire documents; abstract; col. 11, lines 1-26; col. 12, line 56 through col. 13, line 13; claims 1, 9-10) wherein said composition can be delivered in various dosage form including sublingually (col. 5, lines 18-22). The reference discloses that the term “conscious sedation” is used interchangeably with the terms “procedural sedation” and “analgesia” (col. 3, lines 56-63) and that the “pre-sedation” as conscious sedation is induced sedation sometime before the procedure e.g., between 5 minutes and 1 hour prior (col.4, lines 13-16). Table 5 shows a composition comprising midazolam, ketamine and propranolol where ratios of midazolam:ketamine:propranolol are between about 1:2:1, 1:10:1, 1:4:1, 1:6:1 or 1:5:1 (see also claims 9 and 10). Furthermore, the reference discloses exemplary composition comprising midazolam, ketamine and ondansentron in ratio of 3:25:2 (col. 11, lines 20-26). As the specific embodiment, the reference discloses a troche comprising about 0.2g of midazolam, about 2.0g of ketamine and 0.2g of propranolol or ondansetron (Example 1) and a mucoadhesive gel comprising about 0.3g of midazolam, about 2.5g of ketamine hydrochloride and about 0.249 ondansetron (Example 4).
EIN presswire is cited as a reference to demonstrate that the composition described in the Berdahl’102 (which is related to US 10166240 and 10179136 patents) is delivered as a sublingual form.
Regarding claim 4, whether language recited in a “wherein” clause constitutes a claim limitation depends on the specific facts of the case. In the present case, the claim recites that “the level of sedation achieved is measured via the Ramsay sedation scale.” Because this measurement step does not affect the sedation achieved by the prior administration of a pharmaceutical composition within the same or a similar claimed range, the Examiner determines that this step is non-limiting and is not accorded patentable weight. Accordingly, the reference anticipates the claimed invention. Assuming, arguendo, that the reference does not anticipate the claim, the determination of the level of sedation measured by the Ramsay sedation scale would nevertheless have been obvious under 35 U.S.C. § 103, as explained below.
Regarding claim 5, whether language recited in a “wherein” clause constitutes a claim limitation depends on the specific facts of the case. In the present case, the claim recites that “the level of sedation is achieved is greater than a level of sedation achieved by administering midazolam alone or ketamine alone.” Because this recitation simply expresses the intended result of a process step positively recited by the prior administration of a pharmaceutical composition within the same or a similar claimed range, the Examiner determines that this recitation is non-limiting and is not accorded patentable weight. Accordingly, the reference anticipates the claimed invention.
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.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Berdahl et al. (US 10166240 B2, cited in IDS, hereinafter “Berdahl’240”) or Berdahl et al. (US 10391102 B2, cited in IDS, hereinafter “Berdahl’102”as applied to claims 1-3 and 5-7 above, and further in view of Pongpeerapat et al. (US2015/0098983 A1, hereinafter “Pongpeerapat”).
The teaching of Berdahl’240 or Berdahl’102 has been discussed above 102 rejection. However, Berdahl’240 or Berdahl’102 is silent regarding the use of Ramsay sedation scale to measure the level of sedation during the procedure. Pongpeerapat is cited as a supplemental reference to establish that the Ramsey Sedation Scale was well known in the art for evaluating the level of sedation (para. [0042]-[0043]).
Accordingly, it would have been obvious to a person of ordinary skill in the art to incorporate the Ramsay Sedation Scale into the teachings of Berdahl ’240 and/or Berdahl ’102 to assess the level of sedation during the procedure, because one having ordinary skill in the art would have been motivated to do so with reasonable expectation of success, given that the Ramsay Sedation Scale is well known tool for evaluating sedation levels during the procedure.
Claim(s) 8-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Berdahl et al. (US 10166240 B2, cited in IDS, hereinafter “Berdahl’240”) or Berdahl et al. (US 10391102 B2, cited in IDS, hereinafter “Berdahl’102”as applied to claims 1-3 and 5-7 above, and further in view of American Pharmaceutical Review Online publication, “Melt Pharmaceuticals Completes Phase 1 Study for Sublingual, Non-Opioid Pain Candidate”, February 10, 2021, hereinafter “American Pharmaceutical Review”).
Regarding claims 8-10,
The teaching of Berdahl’240 or Berdahl’102 has been discussed above 102 rejection. However, Berdahl’240 or Berdahl’102 is silent regarding i) the specific amount of midazolam and ketamine , namely “about 3mg of midazolam and about 25 mg of ketamine” and “about 3mg of midazolam and about 50 mg of ketamine” and ii) the specific weight ratio of midazolam to ketamine, namely “about 3:50”.
American Pharmaceutical Review discloses that Melt Pharmaceuticals completed Phase 1 study for sublingual form of midazolam and ketamine (3mg midazolam/25mg ketamine and 6mg midazolam/50mg ketamine
Accordingly, it would have been obvious to a person of ordinary skill in the art to select 3mg of midazolam and 25mg of ketamine or 50mg of ketamine (or the specific weight ratio of midazolam to ketamin in 3:50) with reasonable expectation of success since Berhadhl’240, Berdahl’102 and American Pharmaceutical Review are drawn to same endeavors related to inducing procedural sedation by combination of midazolam and ketamine combination.
With respect to the specific pharmacokinetic limitation of the sublingual administration, particularly the specific Cmax value of midazolam or its metabolite 1-hydroxymidazolam, Cmax value of ketamine or its metabolite norketamine recited in claims 11-18,
As discussed above, the prior art teaches administration of midazolam and ketamine in sublingual dosage form in overlapping dosage amounts (or the dosage range or the weight ratio). The claimed Cmax limitation is a pharmacokinetic result that would have been expected from the administration of midazolam and/or ketamine, since Cmax is dependent on dosage and other routine administration condition associated with the sublingual administration of midazolam and/or ketamine. A person having ordinary skill in the art would have had reason to select or adjust the dosage within known range in order to obtain the desired plasma exposure, including Cmax. Therefore, the claimed subject matter would have been obvious over the prior art.
Furthermore, the U.S. Patent Office is not equipped with analytical instruments to test prior art compositions for the infinite number of ways that a subsequent applicant may present previously unmeasured characteristics. When as here, the prior art appears to contain the exact same ingredients and applicant's own disclosure supports the suitability of the prior art composition as the inventive composition component, the burden is properly shifted to applicant to show otherwise. It is noted that “products of identical chemical composition cannot have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990) (see MPEP 2112.01 (II)). The U.S. Patent Office is not equipped with analytical instruments to test prior art compositions for the infinite number of ways that a subsequent applicant may present previously unmeasured characteristics. When as here, the prior art appears to contain the exact same ingredients and applicant's own disclosure supports the suitability of the prior art composition as the inventive composition component, the burden is properly shifted to applicant to show otherwise.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 1-19 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 1-5, 8-12 and 20-28 of copending Application No. 19242284 (reference application). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
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 1-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 6-7 and 13-19 of copending application 19242284. Although the claims at issue are not identical, they are not patentably distinct from each other. Even though the instant claims do not recite the amount of midazolam and/or ketamine in specific mass percentage, the dosage amount or the weight ratio disclosed in both applications are identical or similar in range. Thus, one having ordinary skill in the art would have easily calculated desire amount in mass percentage based on the disclosed dosage amounts or the weight ratio.
Since the instant claim recites open transitional language “comprising” which allows to include additional unrecited components or steps, the referenced claims 13-19 components or steps in preparing sublingual form makes obvious the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-10 and 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 9-19 of U.S. Patent No. 10391102 B2, and in further view of US 10166240. Although the claims at issue are not identical, they are not patentably distinct from each other because both inventions are drawn to a method of inducing procedural sedation. Even though the patented claim does not specifically name i) the combination of midazolam and ketamine, ii) the delivery of said combination in sublingual form, and the specific dosage amounts or ratio, such selection of midazolam and ketamine from finite number of species disclosed in ‘875 application and determination of suitable dosage amounts or weight ratios and/or the route of administration would have been apparent to the those skilled in the art, especially in view of US’240 patent. As discussed above in 102 rejection, the Berdahl’240 teaches or suggests a method of inducing conscious sedation or pre-sedation by administering a composition comprising a benzodiazepine-based compound such as midazolam and a NMDA antagonist such as ketamine, and optionally a beta-blocker, antiemetic, an NSAID and/or an antihistamine medication (entire documents; abstract; col. 5, line 60 through col. 7, line 3; col. 11, lines 2-28; col. 12, lines 60-67; claims 1, 9-10 and 19) wherein said composition can be delivered in various dosage form including sublingually (col. 1, lines 26-34 and col. 2, lines 32-36; col. 3, lines 56-62; col. 11, lines 42-44). The reference discloses that the term “conscious sedation” is used interchangeably with the terms “procedural sedation” and “analgesia” (col. 3, lines 40-47) and that the “pre-sedation” as conscious sedation is induced sedation sometime before the procedure e.g., between 5 minutes and 1 hour prior (col.3, lines 65-67). Table 5 shows a composition comprising midazolam, ketamine and propranolol where ratios of midazolam:ketamine:propranolol are between about 1:2:1, 1:10:1, 1:4:1, 1:6:1 or 1:5:1 (see also claims 9 and 10). Furthermore, the reference discloses exemplary composition comprising midazolam, ketamine and ondansentron in ratio of 3:25:2 (col. 11, lines 21-29). As the specific embodiment, the reference discloses a troche comprising about 0.2g of midazolam, about 2.0g of ketamine and 0.2g of propranolol or ondansetron (Example 1). A person having ordinary skill in the art would have had reason to select or adjust the dosage amounts, the weight ratio or dosage forms of midazolam and ketamine in order to obtain the desired therapeutic effect of the combination. Therefore, the claimed subject matter would have been obvious over the prior art.
Generally, differences in concentration or timing will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or timing is critical.
Since the instant claim recites open transitional language “comprising” which allows to include additional unrecited components or steps, the referenced claims 11-18 components or steps in preparing sublingual form or performing in sedation procedure or during the surgery procedure makes obvious the instant claims.
Claims 1-10 and 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 and 9-21 of U.S. Patent No. 10555952 B2, and in further view of US10166240. Although the claims at issue are not identical, they are not patentably distinct from each other. Even though the patented base claim 1 do not specifically mention the instant method of inducing procedural sedation when the ketamine and midazolam is administered, it must be inherently present in the claimed method when the combination of midazolam and ketamine is administered to the same patient population who is undergoing a medical procedure. Therefore, the patented claims make obvious the instant claimed invention. As to the similar reasons provided in above rejections, a person having ordinary skill in the art would have had reason to select or adjust the dosage amounts, the weight ratio or dosage forms of midazolam and ketamine in order to obtain the desired therapeutic effect of the combination. Therefore, the claimed subject matter would have been obvious over the prior art.
Generally, differences in concentration or timing will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or timing is critical.
Since the instant claim recites open transitional language “comprising” which allows to include additional unrecited components or steps, the referenced claims 12-20 components or steps in preparing sublingual form or performing in sedation procedure or during the surgery procedure makes obvious the instant claims.
Claims 1-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 9-11 and 19 of U.S. Patent No. 10166240 B2, and in further view of US 10391102. Although the claims at issue are not identical, they are not patentably distinct from each other because each other because both inventions are drawn to a method of inducing procedural sedation. Even though the patented base claim 1 does not specifically name i) the combination of midazolam and ketamine and ii) the specific dosage amounts or ratio, such selection of midazolam and ketamine from finite number of species disclosed in ‘240 patent and determination of suitable dosage amounts or weight ratios would have been apparent to the those skilled in the art, especially in view of US’102 patent. As discussed above in 102 rejection, Berdahl’102 teaches or suggests a method of inducing conscious sedation ore pre-sedation by administering a composition comprising a benzodiazepine-based compound such as midazolam and a NMDA antagonist such as ketamine, and optionally a beta-blocker, antiemetic, an NSAID and/or an antihistamine medication (entire documents; abstract; col. 11, lines 1-26; col. 12, line 56 through col. 13, line 13; claims 1, 9-10) wherein said composition can be delivered in various dosage form including sublingually (col. 5, lines 18-22). The reference discloses that the term “conscious sedation” is used interchangeably with the terms “procedural sedation” and “analgesia” (col. 3, lines 56-63) and that the “pre-sedation” as conscious sedation is induced sedation sometime before the procedure e.g., between 5 minutes and 1 hour prior (col.4, lines 13-16). Table 5 shows a composition comprising midazolam, ketamine and propranolol where ratios of midazolam:ketamine:propranolol are between about 1:2:1, 1:10:1, 1:4:1, 1:6:1 or 1:5:1 (see also claims 9 and 10). Furthermore, the reference discloses exemplary composition comprising midazolam, ketamine and ondansentron in ratio of 3:25:2 (col. 11, lines 20-26). As the specific embodiment, the reference discloses a troche comprising about 0.2g of midazolam, about 2.0g of ketamine and 0.2g of propranolol or ondansetron (Example 1) and a mucoadhesive gel comprising about 0.3g of midazolam, about 2.5g of ketamine hydrochloride and about 0.249 ondansetron (Example 4). A person having ordinary skill in the art would have had reason to select or adjust the dosage amounts, the weight ratio or dosage forms of midazolam and ketamine in order to obtain the desired therapeutic effect of the combination. Therefore, the claimed subject matter would have been obvious over the prior art.
Generally, differences in concentration or timing will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or timing is critical.
Since the instant claim recites open transitional language “comprising” which allows to include additional unrecited components or steps, the referenced claims 12-18 components or steps in preparing sublingual form or performing in sedation procedure or during the surgery procedure makes obvious the instant claims.
Claims 1-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 9-15 and 21-23of U.S. Patent No. 10179136 B2, and in further view of US10166240. Although the claims at issue are not identical, they are not patentably distinct from each other because each other because both inventions are drawn to a method of inducing procedural sedation. Even though the patented base claim 1 does not specifically name i) the combination of midazolam and ketamine and ii) the specific dosage amounts or ratio, such selection of midazolam and ketamine from finite number of species disclosed in ‘136 patent and determination of suitable dosage amounts or weight ratios would have been apparent to the those skilled in the art, especially in view of US’240 patent. As discussed above in 102 rejection, the Berdahl’240 teaches or suggests a method of inducing conscious sedation or pre-sedation by administering a composition comprising a benzodiazepine-based compound such as midazolam and a NMDA antagonist such as ketamine, and optionally a beta-blocker, antiemetic, an NSAID and/or an antihistamine medication (entire documents; abstract; col. 5, line 60 through col. 7, line 3; col. 11, lines 2-28; col. 12, lines 60-67; claims 1, 9-10 and 19) wherein said composition can be delivered in various dosage form including sublingually (col. 1, lines 26-34 and col. 2, lines 32-36; col. 3, lines 56-62; col. 11, lines 42-44). The reference discloses that the term “conscious sedation” is used interchangeably with the terms “procedural sedation” and “analgesia” (col. 3, lines 40-47) and that the “pre-sedation” as conscious sedation is induced sedation sometime before the procedure e.g., between 5 minutes and 1 hour prior (col.3, lines 65-67). Table 5 shows a composition comprising midazolam, ketamine and propranolol where ratios of midazolam:ketamin:propranolol are between about 1:2:1, 1:10:1, 1:4:1, 1:6:1 or 1:5:1 (see also claims 9 and 10). Furthermore, the reference discloses exemplary composition comprising midazolam, ketamine and ondansentron in ratio of 3:25:2 (col. 11, lines 21-29). As the specific embodiment, the reference discloses a troche comprising about 0.2g of midazolam, about 2.0g of ketamine and 0.2g of propranolol or ondansetron (Example 1). A person having ordinary skill in the art would have had reason to select or adjust the dosage amounts, the weight ratio or dosage forms of midazolam and ketamine in order to obtain the desired therapeutic effect of the combination. Therefore, the claimed subject matter would have been obvious over the prior art.
Generally, differences in concentration or timing will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or timing is critical.
Since the instant claim recites open transitional language “comprising” which allows to include additional unrecited components or steps, the referenced claims 12-15 and 23 components or steps in preparing sublingual form or performing in sedation procedure or during the surgery procedure makes obvious the instant claims.
Claims 1-19 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-3, 5-10 and 12-16 of U.S. Patent No. 12083126 B2, and in further view of US10166240. Although the claims at issue are not identical, they are not patentably distinct from each other. Even though the patented claims do not recite any method step where the composition is used for inducing procedural sedation, such determination would have been apparent to those skilled in the art in view of ‘240 patent. As discussed above in 102 rejection, the Berdahl’240 teaches or suggests a method of inducing conscious sedation or pre-sedation by administering a composition comprising a benzodiazepine-based compound such as midazolam and a NMDA antagonist such as ketamine, and optionally a beta-blocker, antiemetic, an NSAID and/or an antihistamine medication (entire documents; abstract; col. 5, line 60 through col. 7, line 3; col. 11, lines 2-28; col. 12, lines 60-67; claims 1, 9-10 and 19) wherein said composition can be delivered in various dosage form including sublingually (col. 1, lines 26-34 and col. 2, lines 32-36; col. 3, lines 56-62; col. 11, lines 42-44). The reference discloses that the term “conscious sedation” is used interchangeably with the terms “procedural sedation” and “analgesia” (col. 3, lines 40-47) and that the “pre-sedation” as conscious sedation is induced sedation sometime before the procedure e.g., between 5 minutes and 1 hour prior (col.3, lines 65-67). Table 5 shows a composition comprising midazolam, ketamine and propranolol where ratios of midazolam:ketamin:propranolol are between about 1:2:1, 1:10:1, 1:4:1, 1:6:1 or 1:5:1 (see also claims 9 and 10). Furthermore, the reference discloses exemplary composition comprising midazolam, ketamine and ondansentron in ratio of 3:25:2 (col. 11, lines 21-29). As the specific embodiment, the reference discloses a troche comprising about 0.2g of midazolam, about 2.0g of ketamine and 0.2g of propranolol or ondansetron (Example 1). A person having ordinary skill in the art would have had reason to select or adjust the dosage amounts, the weight ratio or dosage forms of midazolam and ketamine in order to obtain the desired therapeutic effect of the combination. Therefore, the claimed subject matter would have been obvious over the prior art.
Generally, differences in concentration or timing will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or timing is critical.
Since the instant claim recites open transitional language “comprising” which allows to include additional unrecited components or steps, the referenced claims 6-9 and 13-16 components or steps in preparing sublingual form or performing in sedation procedure or during the surgery procedure makes obvious the instant claims.
Conclusion
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/BRIAN-YONG S KWON/ Supervisory Patent Examiner, Art Unit 1613
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