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 .
DETAILED ACTION
Claims 1-5 are pending in the instant application.
Claims 1-5 are examined herein.
Priority
This application is a Continuation of U.S. Patent Application 18/193,083, filed on 30 March 2023, now U.S. Patent 12,076,300, which is a Continuation of U.S. Patent Application 17/789,631, filed on 28 June 2022, now U.S. Patent 12,268,658, which is a National Phase entry of International Application No. PCT/IB2020/062507, filed on 29 December 2020, which claims the benefit of U.S. Provisional Patent Application 62/954,779, filed on 30 December 2019.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 24 October 2024 (6 documents), 10 December 2024 and 28 August 2025, are acknowledged and considered.
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 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 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over Smith-Apeldoorn et al. (BMC Psychiatry 2019, 19 (375), p. 1-9, published 29 November 2019, cited in IDS), in view of Glue et al. (WO 2019/073408, published 18 April 2019, cited in IDS).
Smith-Apeldoorn teaches a method of treating MDD in a human patient in need thereof comprising orally administering to the patient esketamine as add-on to regular antidepressant medication (page 5, left column, first paragraph under Discussion); thus, Smith-Apeldoorn teaches oral administration of esketamine, as in instant claim 1, and further administering an antidepressant to the patient, which is a second medication other than R-ketamine, as in instant claim 4.
The patients in Smith-Apeldoorn suffer from treatment-resistant depression, as in instant claim 5.
The treatment duration is 6 weeks (page 5, right column, second paragraph), which satisfies the limitation of at least 28 days, as in instant claim 1.
The dosing regimen in Smith-Apeldoorn is 1.25 mg/kg daily (page 7, left column, first paragraph), which, for an adult weighing 50 kg, corresponds to 62.5 mg/day, which is close to 60 mg in instant claims.
Smith-Apeldoorn teaches (page 7, left column, second paragraph) that the dosing regimen in the study is fixed at 90 mg per day, based on the weights of the average Dutch man and woman of 84 and 70 kg, respectively.
Smith-Apeldoorn teaches daily administration of esketamine, and records reduction in symptoms of MDD at the end of the treatment regimen (page 3, last paragraph- page 4, first paragraph), as in the instant claims.
Smith-Apeldoorn teaches (Under Study treatment, page 2, last paragraph) administering oral esketamine to MDD patients three times a day during 42 consecutive days. During the first three days, dosages are gradually increased from 10 mg at administration 1 (day 1), to 30 mg at administration 9 (day 3). During the last 3 days, dosages are gradually decreased from 30 mg at administration 118 (day 40) to 10 mg at administration 126 (day 42).
Smith-Apeldoorn teaches (Under Study treatment, page 2, last paragraph) administering esketamine as immediate release capsules.
Smith-Apeldoorn teaches (page 5, right column, last paragraph) that oral administration of (es)ketamine offers the possibility of self-administration, as in instant claim 2.
Smith-Apeldoorn does not teach once daily administration, as in instant claims.
Smith-Apeldoorn does not recite 60 mg immediate release esketamine in the oral dosage form administered, as in the instant claims.
Glue et al. (WO 2019/073408) teach a method of treating treatment resistant depression which is major depressive disorder (page 18, lines 28-29) comprising orally administering to a patient in need thereof an oral dosage form containing, for example, about 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, 70 mg, 80 mg, 90 mg (page 48, lines 16-18) of active ingredient (page 11, lines 7-9) ketamine, where ketamine active agent is, for example (S) ketamine or a pharmaceutical salt thereof (page 22, lines 2-3); the dosage form is suitable for once daily administration (page 11, line 21); the dosage form can be administered for example for four weeks, 5 weeks, six weeks, a month, two month, three months or more, for as long as symptoms continue (page 45, lines 23-26).
Glue teaches (page 45, lines 11-13) that the dose administered must be carefully adjusted according to age, weight, condition of the patient, as well as route of administration, dosage form, regimen and the desired result.
It would have been obvious to a person of ordinary skill in the art to administer oral esketamine to patients suffering from MDD, in the treatment regimen (42 days) taught by Smith-Apeldoorn, at the total daily dose (1.25 mg/kg) taught by Smith-Apeldoorn, calculate individual daily doses of esketamine based on patient’s weight, and use esketamine capsules/oral dosage forms of 60 mg (instead of 90 mg/day as 3 capsules of 30 mg each in Smith-Apeldoorn), because Glue teaches oral dosage forms of ketamine which is esketamine comprising 10 mg, or 20 mg, or 30 mg, or 40 mg, or 50 mg, or 60 mg, or 70 mg, or 80 mg, being administered to treat MDD. Thus, the person of ordinary skill in the art would have reasonably expected that oral administration of esketamine as oral dosage form containing 60 mg of ketamine which is S-ketamine to treat MDD will result in therapeutic effect, as improvement in depression symptoms in MDD patients.
Further, the person of ordinary skill in the art would have explored different frequency of administration, such as once a day administration, as in instant claim 1, because optimizing the frequency of administration of the therapeutic agent and length of treatment regimen in a known method of treatment with a known drug, are well within the skill of the artisan.
The person of ordinary skill in the art would have administered S-ketamine in immediate release dosage forms because these are commercially available forms of esketamine.
Further, the person of ordinary skill in the art would have administered esketamine orally to MDD patients and would have monitored symptoms of depression at the end of the treatment regimen, with the expectation that esketamine is effective to reduce symptoms of depression in said treated MDD patients.
As such, claims 1-5 are rejected as prima facie obvious.
Claims 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over Kagan et al. (US 2020/0147005, priority from US provisional patent application 62/867,354, filed 27 June 2019, cited in IDS), in view of Glue et al. (WO 2019/073408, published 18 April 2019, cited in IDS).
The applied reference, Kagan (US patent application 16/592,930) has a common assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
Kagan teaches (Example 7 in US provisional patent application 62/867,354, filed 27 June 2019; all paragraph numbers in this rejection refer to this provisional application) a method of treating major depressive disorder (MDD) in a human patient in need thereof, comprising orally administering once daily [0106], as in instant claim 1, to said patient for 28 days (2 weeks + 2 weeks, [0106]) an oral dosage form comprising 10 mg, or 20 mg, or 40 mg esketamine; and further administering an additional antidepressant to the patient, for example, fluoxetine, or sertraline [0059], which is a second medication other than R-ketamine, as in instant claim 4. The patienrs suffer from treatment resistant depression, as in instant claim 5. Efficacy in the method of treatment is measured in reduction in symptoms of MDD after 28 days, at in instant claims.
The treatment regimen in Kagan is of at least 28 days [0010] as in the instant claims.
Kagan does not recite 60 mg esketamine in the oral dosage form administered, as in the instant claims.
Glue et al. (WO 2019/073408) teach a method of treating treatment resistant depression which is major depressive disorder (page 18, lines 28-29) comprising orally administering to a patient in need thereof an oral dosage form containing, for example, about 40 mg, 50 mg, 60 mg, 70 mg, 80 mg, (page 48, lines 16-18) of active ingredient (page 11, lines 7-9) ketamine, where ketamine active agent is, for example (S) ketamine or a pharmaceutical salt thereof (page 22, lines 2-3); the dosage form is suitable for once daily administration (page 11, line 21); the dosage form can be administered for example for four weeks, 5 weeks, six weeks, a month, two month, three months or more, for as long as symptoms continue (page 45, lines 23-26).
Glue teaches (page 45, lines 11-13) that the dose administered must be carefully adjusted according to age, weight, condition of the patient, as well as route of administration, dosage form, regimen and the desired result.
It would have been obvious to a person of ordinary skill in the art to administer to patients suffering from MDD an oral dosage form of 60 mg instead of 10 mg, or 20 mg, or 40 mg esketamine (taught by Kagan), to treat MDD, because Glue teaches oral dosage forms of ketamine which is esketamine comprising 40 mg, or 50 mg, or 60 mg, or 70 mg, or 80 mg being administered to treat MDD. Thus, the person of ordinary skill in the art would have reasonably expected that oral administration of 60 mg of ketamine which is S-ketamine to treat MDD will result in therapeutic effect, as improvement in depression symptoms in MDD patients.
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Similar to the rejection above, claims 1-11, 13-15, 19-23 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Kagan et al. (US 2020/0000748, filed 27 June 2019, cited in PTO-892, Example 7), in view of Glue et al. (WO 2019/073408, published 18 April 2019, cited in IDS); and over Kagan et al. (US 2021/0378989, filed 11 October 2019, cited in PTO-892, Example 9), in view of Glue et al. (WO 2019/073408, published 18 April 2019, cited in IDS).
The applied references by Kagan above have a common assignee with the instant application. Based upon the earlier effectively filed date of the reference, they constitute prior art under 35 U.S.C. 102(a)(2).
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 1-5 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-4 of U.S. patent 12,076,300 (cited in IDS).
Although the conflicting claims are not identical, they are not patentably distinct from each other because a method of claims 1-4 of U.S. patent 12,076,300 anticipates or renders obvious the instant claims.
Instant claims 1-5 are drawn to a method of treating major depressive disorder (MDD) in a human patient in need thereof comprising orally administering to said patient an oral dosage form comprising between about 60 mg of esketamine over a treatment regimen of at least 28 days; claim 1 recites once a day administration over the treatment regimen; claim 4 recites further administration of a second medication other than (R)-ketamine.
Claims 1-4 of U.S. patent 12,076,300 are drawn to a method of improving MARDS score of a human patient suffering from major depressive disorder (MDD) at least day 28 of a treatment regimen (as in the instant claims), when compared to placebo comprising orally administering once daily (as in instant claims), at night, to said patient an immediate release dosage form comprising 60 mg of esketamine, as in instant claims; claim 3 recites that the dosage form consists essentially of 60 mg of esketamine; claim 4 recites further comprising the administration of a second medication other than (R)-ketamine (as in instant claim 4).
Claims 1-4 of U.S. patent 12,076,300 are drawn to the same method of treating MDD, in the said patient population, patients suffering from MDD, as in the instant claims, by administering the very same therapeutic agent which is esketamine, via the same route of administration, orally, over the same treatment regimen of at least 28 days.
Claims 1-5 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-19 of U.S. patent 12,268,658 (cited in IDS).
Although the conflicting claims are not identical, they are not patentably distinct from each other because a method of claims 1-19 of U.S. patent 12,268,658 anticipates or renders obvious the instant claims.
Claims 1-19 of U.S. patent 12,268,658 are drawn to a method of treating a human patient suffering from major depressive disorder (MDD) with once daily esketamine administration, orally every 24 hours, an immediate release oral dosage comprising 41 mg 50 80 mg esketamine over a treatment regimen of at least day 28 of a treatment regimen (as in the instant claims),; claim 3 recites that the dosage form consists essentially of 60 mg of esketamine; claim 5 recites 60 mg esketamine, as in the instant claims, claim 13 recites further comprising the administration of a second medication other than (R)-ketamine (as in instant claim 4).
There is significant overlap between the method of claims 1-19 of U.S. patent 12,268,658 and the method of the instant claims.
Claims 1-5 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-20 of U.S. patent 11,253,487 (cited in IDS), in view of Glue et al. (WO 2019/073408, published 18 April 2019, cited in IDS).
Although the conflicting claims are not identical, they are not patentably distinct from each other because a method of claims 1-20 of U.S. patent 11,253,487 renders obvious the instant claims.
Claims 1-20 of U.S. patent 11,253,487 are drawn to a method of treating major depressive disorder (MDD) in a human patient in need thereof, consisting essentially of orally administering once daily to said patient for at least 28 days an oral dosage form comprising 40 mg esketamine; and optionally further administering an additional antidepressant to the patient.
Claims 1-20 of U.S. patent 11,253,487 do not recite 60 mg esketamine in the oral dosage form administered, as in the instant claims.
Glue et al. (WO 2019/073408) teach a method of treating treatment resistant depression which is major depressive disorder (page 18, lines 28-29) comprising orally administering to a patient in need thereof an oral dosage form containing, for example, about 40 mg, 50 mg, 60 mg, 70 mg, 80 mg, (page 48, lines 16-18) of active ingredient (page 11, lines 7-9) ketamine, where ketamine active agent is, for example (S) ketamine or a pharmaceutical salt thereof (page 22, lines 2-3); the dosage form is suitable for once daily administration (page 11, line 21); the dosage form can be administered for example for four weeks, 5 weeks, six weeks, a month, two month, three months or more, for as long as symptoms continue (page 45, lines 23-26).
Glue teaches (page 45, lines 11-13) that the dose administered must be carefully adjusted according to age, weight, condition of the patient, as well as route of administration, dosage form, regimen and the desired result.
It would have been obvious to a person of ordinary skill in the art to administer to patients suffering from MDD an oral dosage form of 60 mg instead of 40 mg esketamine (taught in claims of U.S. patent 11,253,487), to treat MDD, because Glue teaches oral dosage forms of ketamine which is esketamine comprising 40 mg, or 50 mg, or 60 mg, or 70 mg, or 80 mg being administered to treat MDD. Thus, the person of ordinary skill in the art would have reasonably expected that oral administration of 60 mg of ketamine which is S-ketamine to treat MDD will result in therapeutic effect, as improvement in depression symptoms in MDD patients.
Claims 1-5 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-17 of U.S. patent 11,865,088 (cited in IDS), in view of Glue et al. (WO 2019/073408, published 18 April 2019, cited in IDS).
Although the conflicting claims are not identical, they are not patentably distinct from each other because a method of claims 1-17 of U.S. patent 11,865,088 renders obvious instant claims.
Claims 1-17 of U.S. patent 11,865,088 are drawn to a method of treating major depressive disorder (MDD) in a human patient in need thereof comprising orally administering to said patient an oral dosage form comprising between about 20 mg to 40 mg of esketamine over a treatment regimen of at least 28 days; claims 2-4 specifically recite 20 mg, 30 mg, 40 mg esketamine; claim 8 recites once a day administration over the treatment regimen (as in the instant claims); claims 5, 6 recite the length of treatment regimen 28 days to 730 days, or for at least a year.
Claims 1-17 of U.S. patent 11,865,088 are drawn to the same method of treating MDD, in the said patient population, patients suffering from MDD, as in the instant claims, by administering the very same therapeutic agent which is esketamine, via the same route of administration, orally, over the same treatment regimen of at least 28 days; the difference is that the instant claims recite 60 mg esketamine in the oral dosage form administered in the method, while claims 1-17 of U.S. patent 11,865,088 recite 20 mg, 30 mg, 40 mg esketamine.
Glue et al. (WO 2019/073408) teach a method of treating treatment resistant depression which is major depressive disorder (page 18, lines 28-29) comprising orally administering to a patient in need thereof an oral dosage form containing about 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, 70 mg, 80 mg, 90 mg, 100 mg, 125 mg (page 48, lines 16-18) or about 60 mg or about 120 mg of active ingredient (page 11, lines 7-9) ketamine, where ketamine active agent is , for example (S) ketamine or a pharmaceutical salt thereof (page 22, lines 2-3); the dosage form is suitable for once daily administration (page 11, line 21); the dosage form can be administered for example for four weeks, 5 weeks, six weeks, a month, two month, three months or more, for as long as symptoms continue (page 45, lines 23-26).
Glue teaches (page 45, lines 11-13) that the dose administered must be carefully adjusted according to age, weight, condition of the patient, as well as route of administration, dosage form, regimen and the desired result.
It would have been obvious to a person of ordinary skill in the art to administer to patients suffering from MDD an oral dosage form of 60 mg esketamine to treat MDD, because Glue teaches oral dosage forms of ketamine which is esketamine comprising 20 mg, or 30 mg, or 40 mg or 50 mg or 60 mg or 70 mg or 80 mg being administered to treat MDD. Thus, the person of ordinary skill in the art would have reasonably expected that oral administration of 60 mg of ketamine which is S-ketamine to treat MDD will result in therapeutic effect, as improvement in depression symptoms in MDD patients.
Claims 1-5 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-20 of U.S. patent 12,016,832 (cited in IDS), in view of Glue et al. (WO 2019/073408, published 18 April 2019, cited in IDS).
Although the conflicting claims are not identical, they are not patentably distinct from each other because a method of claims 1-20 of U.S. patent 12,016,832 renders obvious the instant claims.
Claims 1-20 of U.S. patent 12,016,832 are drawn to a method of treating major depressive disorder (MDD) in a human patient in need thereof, comprising orally administering once daily to said patient for at least 28 days an oral dosage form comprising 40 mg esketamine.
Claims 1-20 of U.S. patent 12,016,832 are drawn to the same method of treating MDD, in the said patient population, patients suffering from MDD, as in the instant claims, by administering the very same therapeutic agent which is esketamine, via the same route of administration, orally, over the same treatment regimen of at least 28 days; the difference is that the instant claims recite 60 mg esketamine in the oral dosage form administered in the method, while claims 1-20 of U.S. patent 12,016,832 recite 40 mg esketamine.
Glue et al. (WO 2019/073408) teach a method of treating treatment resistant depression which is major depressive disorder (page 18, lines 28-29) comprising orally administering to a patient in need thereof an oral dosage form containing about 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, 70 mg, 80 mg, 90 mg, 100 mg, 125 mg (page 48, lines 16-18) or about 60 mg or about 120 mg of active ingredient (page 11, lines 7-9) ketamine, where ketamine active agent is , for example (S) ketamine or a pharmaceutical salt thereof (page 22, lines 2-3); the dosage form is suitable for once daily administration (page 11, line 21); the dosage form can be administered for example for four weeks, 5 weeks, six weeks, a month, two month, three months or more, for as long as symptoms continue (page 45, lines 23-26).
Glue teaches (page 45, lines 11-13) that the dose administered must be carefully adjusted according to age, weight, condition of the patient, as well as route of administration, dosage form, regimen and the desired result.
It would have been obvious to a person of ordinary skill in the art to administer to patients suffering from MDD an oral dosage form of 60 mg instead of 40 mg esketamine (taught in claims of co-pending U.S. patent application 17/571,731), to treat MDD, because Glue teaches oral dosage forms of ketamine which is esketamine comprising 40 mg or 50 mg, or 60 mg, or 70 mg, or 80 mg being administered to treat MDD. Thus, the person of ordinary skill in the art would have reasonably expected that oral administration of 60 mg of ketamine which is S-ketamine to treat MDD will result in therapeutic effect, as improvement in depression symptoms in MDD patients.
Claims 1-5 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-17 of U.S. patent 11,957,645 (cited in IDS), in view of Glue et al. (WO 2019/073408, published 18 April 2019, cited in IDS).
Although the conflicting claims are not identical, they are not patentably distinct from each other because a method of claims 1-17 of U.S. patent 11,957,645 renders obvious the instant claims.
Claims 1-17 of U.S. patent 11,957,645 are drawn to a method of treating major depressive disorder (MDD) in a human patient in need thereof comprising
orally administering once daily to said patient for at least 28 days, an oral dosage form comprising esketamine;
wherein the oral dosage form is self-administered by the human patient at night;
wherein the esketamine Cmax of said administration is between 15 ng/mL and 30 ng/mL; wherein following said administration, the patient is restricted from driving for no more than eight hours; and wherein the human patient’s symptoms of MDD are measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) score at least day 28 of the treatment regimen and are reduced at least day 28 of the treatment regimen as compared to placebo.
Claims 1-17 of U.S. patent 11,957,645 are drawn to the same method of treating MDD, in the said patient population, patients suffering from MDD, as in the instant claims, by administering the very same therapeutic agent which is esketamine, via the same route of administration, orally, over the same treatment regimen of at least 28 days; the difference is that the instant claims recite specifically 60 mg esketamine in the oral dosage form administered in the method, while claims 1-17 of U.S. patent 11,957,645 do not recite an amount of esketamine administered, but rather the Cmax achieved upon administration of esketamine. However, the Cmax in the claims of co-pending U.S. patent application 18/193,122 (Cmax between 15 ng/mL and 30 ng/mL) and in the present claims (Cmax 30 ng/ml or less) overlap.
Glue et al. (WO 2019/073408) teach a method of treating treatment resistant depression which is major depressive disorder (page 18, lines 28-29) comprising orally administering to a patient in need thereof an oral dosage form containing about 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, 70 mg, 80 mg, 90 mg, 100 mg, 125 mg (page 48, lines 16-18) or about 30 mg, or 60 mg or about 120 mg of active ingredient (page 11, lines 7-9) , where the dosage form provides a ketamine Cmax between 12 and 42 ng/ml (page 11, line 13), where ketamine active agent is , for example (S) ketamine or a pharmaceutical salt thereof (page 22, lines 2-3); the dosage form is suitable for once daily administration (page 11, line 21); the dosage form can be administered for example for four weeks, 5 weeks, six weeks, a month, two month, three months or more, for as long as symptoms continue (page 45, lines 23-26).
Glue teaches (page 45, lines 11-13) that the dose administered must be carefully adjusted according to age, weight, condition of the patient, as well as route of administration, dosage form, regimen and the desired result.
The Cmax between 12 and 42 ng/ml (page 11, line 13) taught by Glue encompasses the Cmax (15 ng/ml to 30 ng/ml) in claim 1 of co-pending U.S. patent application 18/193,122 and overlaps with the Cmax in the instant claims (30 ng/ml or less). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) "[A] prior art reference that discloses a range encompassing a somewhat narrower claimed range is sufficient to establish a prima facie case of obviousness." In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003). MPEP 2144.05.
It would have been obvious to a person of ordinary skill in the art to administer to patients suffering from MDD an oral dosage form of 60 mg esketamine to treat MDD, because claims 1-17 of U.S. patent 11,957,645 teach that orally administering esketamine wherein the esketamine Cmax of said administration is between 15 ng/mL and 30 ng/mL is effective to treat major depressive disorder (MDD) in a human patient in need thereof, and Glue teaches oral dosage forms of ketamine which is esketamine comprising about 30 mg, or 40 mg, or 50 mg, or 60 mg, or 70 mg, or 80 mg, where the dosage form provides a Cmax between 12 and 42 ng/ml, being administered to treat MDD. Thus, the person of ordinary skill in the art would have reasonably expected that oral administration of 60 mg of ketamine which is esketamine to treat MDD will result in therapeutic effect, as improvement in depression symptoms in MDD patients.
Claims 1-5 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-17 of U.S. patent 12,036,189 (cited in IDS), in view of Glue et al. (WO 2019/073408, published 18 April 2019, cited in IDS).
Although the conflicting claims are not identical, they are not patentably distinct from each other because a method of claims 1-17 of U.S. patent 12,036,189 renders obvious the instant claims.
Claims 1-17 of U.S. patent 12,036,189 are drawn to a method of treating major depressive disorder (MDD) in a human patient in need thereof comprising
orally administering daily to said patient for at least 28 days, an oral dosage form comprising esketamine;
wherein (a) the esketamine Cmax of said administration is between 5 ng/mL and 30 ng/mL; and wherein the human patient’s symptoms of MDD are reduced by the Montgomery-Åsberg Depression Rating Scale (MADRS) score at at least day 28 of the treatment regimen as compared to baseline.
Claims 1-17 of U.S. patent 12,036,189 are drawn to the same method of treating MDD, in the said patient population, patients suffering from MDD, as in the instant claims, by administering the very same therapeutic agent which is esketamine, via the same route of administration, orally, over the same treatment regimen of at least 28 days; the difference is that the instant claims recite specifically 60 mg esketamine in the oral dosage form administered in the method, while claims 1-17 of U.S. patent 12,036,189 do not recite an amount of esketamine administered, but rather the Cmax achieved upon administration of esketamine.
Glue et al. (WO 2019/073408) teach a method of treating treatment resistant depression which is major depressive disorder (page 18, lines 28-29) comprising orally administering to a patient in need thereof an oral dosage form containing about 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, 70 mg, 80 mg, 90 mg, 100 mg, 125 mg (page 48, lines 16-18) or about 30 mg, or 60 mg or about 120 mg of active ingredient (page 11, lines 7-9) , where the dosage form provides a ketamine Cmax between 12 and 42 ng/ml (page 11, line 13), where ketamine active agent is, for example (S) ketamine or a pharmaceutical salt thereof (page 22, lines 2-3); the dosage form is suitable for once daily administration (page 11, line 21); the dosage form can be administered for example for four weeks, 5 weeks, six weeks, a month, two month, three months or more, for as long as symptoms continue (page 45, lines 23-26).
Glue teaches (page 45, lines 11-13) that the dose administered must be carefully adjusted according to age, weight, condition of the patient, as well as route of administration, dosage form, regimen and the desired result.
The Cmax between 12 and 42 ng/ml (page 11, line 13) taught by Glue overlaps with the Cmax (5 ng/ml to 30 ng/ml) in claim 1 of co-pending U.S. patent application 16/454,399 and with the Cmax (30 ng/ml or less) in the instant claims. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) MPEP 2144.05.
It would have been obvious to a person of ordinary skill in the art to administer to patients suffering from MDD an oral dosage form of 41 mg to 80 mg esketamine to treat MDD, because claims 1-3, 10-23, 25-31 of co-pending U.S. patent application 16/454,399 teach that orally administering esketamine wherein the esketamine Cmax of said administration is between 5 ng/mL and 30 ng/mL is effective to treat major depressive disorder (MDD) in a human patient in need thereof, and Glue teaches oral dosage forms of ketamine which is esketamine comprising about 30 mg, or 40 mg, or 50 mg, or 60 mg, or 70 mg, or 80 mg, where the dosage form provides a Cmax between 12 and 42 ng/ml, being administered to treat MDD. Thus, the person of ordinary skill in the art would have reasonably expected that oral administration of 60 mg of ketamine which is esketamine to treat MDD will result in therapeutic effect, as improvement in depression symptoms in MDD patients.
Claims 1-5 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable at least over claims 1-15 of U.S. patent 12,364,672 (cited in IDS), in view of Glue et al. (WO 2019/073408, published 18 April 2019, cited in IDS).
Although the conflicting claims are not identical, they are not patentably distinct from each other because a method of claims 1-15 of U.S. patent 12,364,672 renders obvious the instant claims.
Claims 1-15 of U.S. patent 12,364,672 are drawn to a method of treating major depressive disorder (MDD) in a human patient in need thereof, comprising (a) administering an effective amount of a rapid acting antidepressant over 7 days and (b) orally administering once daily to said patient for at least 28 days an oral dosage form comprising between about 5 mg and 40 mg esketamine; claims 23-28 also disclose the esketamine Cmax and AUC, which inherently occur upon said administration, and which overlap with the values in instant claim 1.
Claims 1-15 of U.S. patent 12,364,672 are drawn to the same method of treating MDD, in the said patient population, patients suffering from MDD, as in the instant claims, with a combination therapy which includes administering the very same therapeutic agent which is esketamine, via the same route of administration, orally, over the same treatment regimen of at least 28 days; the difference is that the instant claims recite 60 mg esketamine in the oral dosage form administered in the method, while claims 1-15 of U.S. patent 12,364,672 recite 5 mg to 40 mg esketamine.
Glue et al. (WO 2019/073408) teach a method of treating treatment resistant depression which is major depressive disorder (page 18, lines 28-29) comprising orally administering to a patient in need thereof an oral dosage form containing about 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, 70 mg, 80 mg, (page 48, lines 16-18) of active ingredient (page 11, lines 7-9) ketamine, where ketamine active agent is , for example (S) ketamine or a pharmaceutical salt thereof (page 22, lines 2-3); the dosage form is suitable for once daily administration (page 11, line 21); the dosage form can be administered for example for four weeks, 5 weeks, six weeks, a month, two month, three months or more, for as long as symptoms continue (page 45, lines 23-26).
Glue teaches (page 45, lines 11-13) that the dose administered must be carefully adjusted according to age, weight, condition of the patient, as well as route of administration, dosage form, regimen and the desired result.
It would have been obvious to a person of ordinary skill in the art to administer to patients suffering from MDD an oral dosage form of 60 mg mg instead of 5 mg to 40 mg esketamine (taught in claims 1-15 of U.S. patent 12,364,672), to treat MDD, because Glue teaches oral dosage forms of ketamine which is esketamine comprising 20 mg, or 30 mg, or 40 mg or 50 mg, or 60 mg, or 70 mg, or 80 mg being administered to treat MDD. Thus, the person of ordinary skill in the art would have reasonably expected that oral administration of 60 mg of ketamine which is S-ketamine to treat MDD will result in therapeutic effect, as improvement in depression symptoms in MDD patients.
For similar reasons, instant claims 1-5 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-9 of U.S. patents 12,514,831 (cited in IDS); 12,336,970 (cited in IDS); 12,280,022 (cited in IDS), all in view of Glue et al. (WO 2019/073408, published 18 April 2019, cited in IDS); and
are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims of co-pending U.S. Patent applications 19/072,349; 19/244,363; 19/344,881; 18/772,474, all in view of Glue et al. (WO 2019/073408, published 18 April 2019, cited in IDS).
Conclusion
Claims 1-5 are rejected.
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/IRINA NEAGU/Primary Examiner, Art Unit 1629
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