DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
Claims 3-5 are rejected under 35 U.S.C. 103(a) as being unpatentable over Somaxon (Somaxon Pharmaceuticals Announces Positive Results in a Phase II…, Somaxon Pharmaceuticals, p. 1-3, April 2005) in view of Ancoli-Isreal et al (Sleep Medicine Reviews, 1(1), p. 3-17, 1997).
Scope of prior art
Somaxon teaches a method of treating insomnia in an elderly patient comprising administering to a patient over the age of 65 doxepin at 3 or 6mg (p. 2, first paragraph). The treatment is taught to be efficacious at both doses and to result in no difference in adverse effect or next day residual effects versus placebo at both doses (p. 1, first paragraph). The treatment is further taught to be improve all sleep maintenance indicators including wake time during sleep, wake after sleep onset, sleep efficiency, total sleep time as well as sleep quality (p. 2, first and second paragraph). Since Somaxon does not report adverse effects with 3mg of doxepin, the treatment step meets the limitation directed to treatment of elderly patient with 3mg of doxepin.
Ascertaining the difference
Somaxon does not expressly teach identifying a patient who is susceptible to the adverse effects of confusion and residual sedation prior to administering the drug, i.e. an elderly patient.
Somaxon does not expressly teach the limitation direct to fragmented sleep in the 8th hour.
Somaxon does not teach dose escalation from 3 to 6mg if desired outcome is not achieved.
Secondary reference
Ancoli-Isreal et al teaches that there is an increased risk of adverse reaction to sleep medication for the treatment of insomnia in elderly patients, including residual sedation and confusion and thus sleep medication should be prescribed at the lowest possible dosage possible in this patient population (p. 12, 1st full paragraph and p. 13, last paragraph). Ancoli-Israel therefore teaches that the elderly population represents a population that is the at-risk population and the elderly population in Somaxon represents the currently claimed patient population.
Obviousness
It would have been prima facie obvious to one of ordinary skill in the art at the time of the instantly claimed invention to treat insomnia in a subject of age 65 or older with daily dosage of 3mg doxepin. Additionally, it would have been prima facie obvious to one of ordinary skill in the art to identify a patient who is susceptible to the adverse effects of confusion and residual sedation prior to administering the drug. These are known side effects of sleep medication in the elderly patient population. By practicing the method of Somaxon on an elderly patient, a patient who is at risk of experiencing side effects of sleep medication is inherently identified. Inherency is based on the teaching of Ancoli-Israel where art teaches increased risk of adverse side effects in an elderly population. Furthermore it would have been prima facie obvious to one of ordinary skill in the art to administer the therapy to a patient suffering from insomnia characterized by fragmented sleep during the eight hour of sleep/sleep maintenance insomnia, since the therapy was known to result in improvement in all sleep maintenance indicators including wake time during sleep, wake after sleep onset, sleep efficiency, total sleep time as well as sleep quality, thus resulting in the practice of the instantly claimed invention with a reasonable expectation of success.
With regard to the administration of the drug on daily schedule, it is obvious from the above teachings that Ancoli-Isreal et al expressly contemplates variation in the dosage amounts and schedule of the active agents and specifically acknowledges that such a matter was well within the skill of the artisan at the time of the invention and would not have required undue experimentation or have been outside the realm of knowledge generally available to the skilled artisan. Factors that would have been taken into consideration when making such a determination would have included, but not have been limited to, the age, weight, sex, diet and medical condition of the patient, severity of the disease, route of administration, pharmacological considerations, e.g., activity, efficacy, pharmacokinetics and toxicology profiles of the particular compound employed, whether a drug delivery system is utilized and whether the compound is administered as part of a drug combination. Thus, the dosage regimen and/or schedule of administration that would have actually been employed would have been expected to vary widely and, in the absence of evidence to the contrary, would not have been inconsistent with that which is presently claimed.
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 1-6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 3-9 of U.S. Patent No. 11,234,954. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘954 patent comprise a step of administering a daily dose of 3mg of doxepin to a patient who is 65yo or older who requires treatment for insomnia. Claim 9 is directed to a 3mg not causing next day sedation. Claim 8 is directed to patients with difficulties with sleep maintenance. Claim 3 is directed to a method where the patient is susceptible to side effects of sleep medication. Claim 1 of the ‘954 patent also recites dose escalation from 3 to 6mg/day.
While the claims of the ‘954 patent are limited to simultaneous treatment of a patient who is older than 65 and of a patient who is younger than 65, a POSA would recognize that the two treatments can administered to the patients separately at different times. It would be obvious to treat insomnia in a patient over 65 when treatment is required without identifying and treating a younger patient at the same time.
Claims 1-6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 and 20 of U.S. Patent No. 8,513,299 in view of Somaxon (Somaxon Pharmaceuticals Announces Positive Results in a Phase II…, Somaxon Pharmaceuticals, p. 1-3, April 2005)
Although the claims at issue are not identical, they are not patentably distinct from each other because claims of the ‘299 patent are directed to treating early awakenings in a patient. The method comprises administration of 3mg of doxepin (claim 20). Early awakening is a form of insomnia (see current claim 3, where insomnia is fragmented sleep in the 8th hour of sleep). By administering 3mg of doxepin, the method of treating insomnia is practiced. With regards to patient population, both, over and under 65yo patients are within the scope of the ‘299 patent. It would have been obvious to administer 3mg to any patient in need of treatment with an expectation that sleep would be improved. Somaxon teaches a method of treating insomnia in an elderly patient comprising administering to a patient over the age of 65 doxepin at 3 or 6mg (p. 2, first paragraph). The treatment is taught to be efficacious at both doses and to result in no difference in adverse effect or next day residual effects versus placebo at both doses (p. 1, first paragraph). Since Somaxon teaches that 3mg dose is safe for elderly population, practicing the method of the ‘207 patent on a population over the age of 65 is obvious. With regards to escalation from 3 to 6mg/day if the desired effect is not achieved, ‘299 claims treatment with both doses (claims 13 and 14) while Somaxon teaches that both doses are safe for treatment of insomnia. A skilled artisan would have found it obvious try a higher dose of 6 mg/day as recited in claim 14 of ‘299 with an expectation that a higher dose will yield improved outcome.
Claims 1-6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-24 of U.S. Patent No. 7,915,307 in view of Somaxon (Somaxon Pharmaceuticals Announces Positive Results in a Phase II…, Somaxon Pharmaceuticals, p. 1-3, April 2005)
Although the claims at issue are not identical, they are not patentably distinct from each other because claims of the ‘307 patent are directed to a method of treating insomnia comprising administration of 3mg of doxepin (claim 17). The claims also comprise limitations directed to minimizing next day residual sedation by providing a 3mg dose of doxepin. (claim 11). While claims of the ‘307 patent do not limit the patient population to 65 yours old or older, it would have been obvious to treat insomnia in any subject in need of such treatment. Somaxon teaches a method of treating insomnia in an elderly patient comprising administering to a patient over the age of 65 doxepin at 3 or 6mg (p. 2, first paragraph). The treatment is taught to be efficacious at both doses and to result in no difference in adverse effect or next day residual effects versus placebo at both doses (p. 1, first paragraph). Since Somaxon teaches that 3mg dose is safe for elderly population, practicing the method of the ‘207 patent on a population over the age of 65 is obvious. . With regards to escalation from 3 to 6mg/day if the desired effect is not achieved:” ‘307claims treatment with both doses while Somaxon teaches that both doses are safe for treatment of insomnia. A skilled artisan would have found it obvious try a higher dose of 6 mg/day if the lower dose produces unsatisfactory results with an expectation that a higher dose will yield improved outcome. With regards to improvement in sleep at 8th hour of sleep, ‘307 claims improvement in sleep quality, but does not specify fragmented sleep at 8th hour. Nevertheless, improvement in fragmented sleep in 8th hour is within the scope of improvement of sleep quality and additionally, Somaxon improvement in all sleep maintenance indicators including wake time during sleep, wake after sleep onset, sleep efficiency, total sleep time as well as sleep quality by administration of doxepin. Treatment of fragmented sleep in 8th hour is therefore obvious because the broad teachings of ‘307 and Somaxon encompass it.
Conclusion
Claims 1-6 are pending
Claims 1-6 are rejected
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/YEVGENY VALENROD/Primary Examiner, Art Unit 1628