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 .
Claim Status
Claims 1-14 and 19-20 are pending. Claims 1-14 and 19-20 are rejected.
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 6-10 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 6 and 7 recite the limitations "the first dose of dexmedetomidine" in line 1 and “the second dose of dexmedetomidine” in line 2. There is insufficient antecedent basis for these limitations in the claims. Independent claim 1 only recites the method of treating comprising administering at least one daily dose of dexmedetomidine. As such, it is unclear if claims 6 and 7 require that the subject be administered a second dose or if methods wherein the subject only receives a first dose of the recited amount would be encompassed by the claims.
Claims 8-10 are rejected for failing to obviate the indefiniteness of claim 7 from which they depend.
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) 1-3 and 5-14 are rejected under 35 U.S.C. 103 as being unpatentable over US 20190365715 A1 by Nandabalan et al. in view of Healthline. “How Long Does Depression Last?”. Last updated May 21, 2018. Accessed March 4, 2026 at https://www.healthline.com/health/how-long-does-depression-last.
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
The prior art teaches the “use of sublingual dexmedetomidine for the treatment of agitation” (title) and discloses methods of administering dexmedetomidine for the treatment of agitation associated with depression (paragraph [0006]).
Regarding instant claims 2 and 5, the prior art teaches the compound may be administered once or twice per day at doses of about 30 mcg or about 40 mcg (paragraphs [0189] and [0190]).
Regarding instant claim 3, Nandabalan et al. state that depending on the physiology of the subject and the desired therapeutic effect, the duration of dosage intervals and treatment protocols may vary. Accordingly, a person of ordinary skill seeking to maintain the effects of twice daily administration of dexmedetomidine over the course of a day would be motivated to administer the first dose in the morning and the second dose in the evening.
Instant claims 6-7 are rejected as indefinite as it is unclear if claims 6 and 7 require that the subject be administered a second dose or if methods wherein the subject only receives a first dose of the recited amount would be encompassed by the claims. Therefore, the instant claims are obvious in view of the prior art method which comprises administering 30 mcg or 40 mcg of dexmedetomidine as a single daily dose.
Regarding instant claims 8-10, the prior art teaches films for oromucosal administration of dexmedetomidine (paragraph [0174]).
Regarding instant claim 11, the prior art discloses that treating embraces preventative therapy (paragraph [0070]). Therefore, the prior art method of treating agitation in a subject with depression embraces preventing agitation and administering dexmedetomidine to subjects who are non-agitated at the time of administration.
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
The prior art discloses a method of treating depression by administering dexmedetomidine but does not specify that the method comprises administering the compound to a subject for at least 14 days or in combination with an anti-depressant.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
Healthline discusses symptoms and treatment for depression or major depressive disorder. The prior art teaches that the condition requires experiencing at least five symptoms daily for a minimum of two weeks to be diagnosed and can last weeks, months or years if untreated (page 1). The prior art teaches that anti-depressants such as SSRIs or SNRIs are helpful for some subjects (pages 4-5). Accordingly, a person of ordinary skill seeking to treat agitation associated with depression in the method of Nandabalan et al. would be motivated to administer dexmedetomidine for at least 14 days as the condition may last for several weeks or months as taught by Healthline (corresponding to instant claim 1). Additionally, a person of ordinary skill would be motivated to combine administration of dexmedetomidine with an anti-depressant for the duration to improve treatment outcomes (corresponding to instant claims 1 and 13-14). See MPEP 2144.06 which states:
"It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980)
Regarding instant claim 12, Healthline states that in some situations anti-anxiety medications may also be administered to subjects (page 5). Accordingly, a person of ordinary skill treating agitation in subjects with depression could expect to encounter subjects whose depression is associated with anxious distress and would be motivated to treat these subjects in the prior art method as well.
Claim(s) 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over US 20190365715 A1 by Nandabalan et al. in view of Healthline. “How Long Does Depression Last?”. Last updated May 21, 2018. Accessed March 4, 2026 at https://www.healthline.com/health/how-long-does-depression-last. as applied to claims 1-3 and 5-14 above, and further in view of Hillhouse et al. A brief history of the development of antidepressant drugs: from monoamines to glutamate. Exp Clin Psychopharmacol. 2015 Feb;23(1):1-21.
Nandabalan et al. and Healthline in combination teach a method of treating depression by administering dexmedetomidine for at least 14 days in combination with an anti-depressant; however, the prior art does not disclose the anti-depressants of instant claims 19-20.
Hillhouse review the history of the development of antidepressant drugs including selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs). The prior art teaches citalopram and escitalopram as FDA approved SSRIs as well as venlafaxine as an FDA approved SNRI. Accordingly, a person of ordinary skill seeking to treat depression in the combined method of Nandabalan et al. and Healthline would have been motivated to administer one of the antidepressants reviewed by Hillhouse in order to improve treatment outcomes.
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, 5-14 and 19-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 10792246; claims 1-8 of U.S. Patent No. 11478422; claims 1-27 of U.S. Patent No. 11497711; claims 1-24 of U.S. Patent No. 11517524; and claims 1-29 of U.S. Patent No. 11559484 in view of US 20190365715 A1 by Nandabalan et al., Healthline. “How Long Does Depression Last?”. Last updated May 21, 2018. Accessed March 4, 2026 at https://www.healthline.com/health/how-long-does-depression-last., and Hillhouse et al. A brief history of the development of antidepressant drugs: from monoamines to glutamate. Exp Clin Psychopharmacol. 2015 Feb;23(1):1-21.
The patent disclose pharmaceutical compositions comprising dexmedetomidine in the form of a film which serves as the basis of a rejection under 35 USC 103. With respect to the fact that the claims of the patents are drawn to compositions while the instant claims are drawn to methods of treating depression, Applicant is directed to Sun Pharmaceutical Industries Ltd. v. Eli Lilly and Co. 95 USPQ2d 1797, Geneva Pharmaceuticals, Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373 [68 USPQ2d 1865] (Fed. Cir. 2003), and Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc., 518 F.3d 1353 [86 USPQ2d 1001] (Fed. Cir. 2008) for analogous situations. The instantly claimed utilities are disclosed in Col. 25, lines 54-55 of patent ‘246, Col. 25, lines 60-61 of patent ‘422, Col. 25, lines 60-61 of patent ‘711, Col. 25, lines 60-61 of patent ‘524, and Col. 25, lines 58-60 of patent ‘484. The teachings and rationale of Nandabalan et al., Healthline and Hillhouse et al. relative to instant claims 1-3 and 5-14 are incorporated here by reference. The instant claims are deemed to be variants of the subject matter of the patents for the same reasons as under 35 USC 103.
Claims 1-3, 5-14 and 19-20are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 11806429 in view of US 20190365715 A1 by Nandabalan et al., Healthline. “How Long Does Depression Last?”. Last updated May 21, 2018. Accessed March 4, 2026 at https://www.healthline.com/health/how-long-does-depression-last., and Hillhouse et al. A brief history of the development of antidepressant drugs: from monoamines to glutamate. Exp Clin Psychopharmacol. 2015 Feb;23(1):1-21.
Claim 1 of the patent discloses a method of treating agitation in patient comprising administering a film comprising dexmedetomidine which serves as the basis of a rejection under 35 USC 103. The teachings and rationale of Nandabalan et al., Healthline and Hillhouse et al. relative to instant claims 1-3 and 5-14 are incorporated here by reference. The instant claims are deemed to be variants of the subject matter of the patent for the same reasons as under 35 USC 103.
Claims 1-14 and 19-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11998529 in view of US 20190365715 A1 by Nandabalan et al., Healthline. “How Long Does Depression Last?”. Last updated May 21, 2018. Accessed March 4, 2026 at https://www.healthline.com/health/how-long-does-depression-last., and Hillhouse et al. A brief history of the development of antidepressant drugs: from monoamines to glutamate. Exp Clin Psychopharmacol. 2015 Feb;23(1):1-21.
Claim 1 of the patent discloses a method of treating agitation by administering an oromucosal formulation comprising dexmedetomidine which serves as the basis of a rejection under 35 USC 103. The teachings and rationale of Nandabalan et al., Healthline and Hillhouse et al. relative to instant claims 1-3 and 5-14 are incorporated here by reference. The instant claims are deemed to be variants of the subject matter of the patent for the same reasons as under 35 USC 103.
Regarding instant claim 4, claim 1 of the patent discloses administering a first dose at 60 mcg and second dose of 80 mcg or 90 mcg.
Claims 1-14 and 19-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 12109196 in view of US 20190365715 A1 by Nandabalan et al., Healthline. “How Long Does Depression Last?”. Last updated May 21, 2018. Accessed March 4, 2026 at https://www.healthline.com/health/how-long-does-depression-last., and Hillhouse et al. A brief history of the development of antidepressant drugs: from monoamines to glutamate. Exp Clin Psychopharmacol. 2015 Feb;23(1):1-21.
Claim 1 of the patent discloses a method of treating agitation by administering an oromucosal formulation comprising dexmedetomidine which serves as the basis of a rejection under 35 USC 103. The teachings and rationale of Nandabalan et al., Healthline and Hillhouse et al. relative to instant claims 1-3 and 5-14 are incorporated here by reference. The instant claims are deemed to be variants of the subject matter of the patent for the same reasons as under 35 USC 103.
Regarding instant claim 4, claim 1 of the patent discloses administering a first dose at 60 mcg and second dose of 80 mcg, 90 mcg, or 120 mcg.
Claims 1-3, 5-14 and 19-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7-8, 12-13, 18, and 20-33 of copending Application No. 18/812,515 in view of US 20190365715 A1 by Nandabalan et al., Healthline. “How Long Does Depression Last?”. Last updated May 21, 2018. Accessed March 4, 2026 at https://www.healthline.com/health/how-long-does-depression-last., and Hillhouse et al. A brief history of the development of antidepressant drugs: from monoamines to glutamate. Exp Clin Psychopharmacol. 2015 Feb;23(1):1-21.
Copending claim 1 discloses a method of treating agitation by administering dexmedetomidine which serves as the basis of a rejection under 35 USC 103. The teachings and rationale of Nandabalan et al., Healthline and Hillhouse et al. relative to instant claims 1-3 and 5-14 are incorporated here by reference. The instant claims are deemed to be variants of the subject matter of the copending application for the same reasons as under 35 USC 103.
This is a provisional nonstatutory double patenting rejection.
Conclusion
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/A.A.C./Examiner, Art Unit 1626
/MATTHEW P COUGHLIN/Primary Examiner, Art Unit 1626