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 Rejections - 35 USC § 112
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 1-13 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. The claims are directed to a method of treating primary or secondary insomnia related to sleep deprivation. It is unclear which conditions are included and which are excluded from the claimed invention. Primary insomnia is an insomnia with no identifiable cause. However, applicants are claiming that sleep depravation is the cause of insomnia. Insomnia due to sleep depravation is secondary insomnia because there is an underlying cause. It is therefore unclear which types of insomnias are within the scope of the claims.
Claim Objections
Claim 11 is objected to. There two claims numbered 11.
Claim interpretation
Claims are directed to a method of treating insomnia related to sleep deprivation. While the claims fail specify the exact nature of the relationship between insomnia and sleep deprivation, Examiner is interpreting this limitation to include insomnia caused by sleep deprivation. In this interpretation, the claims encompass treatment of secondary insomnia where the underlying cause is sleep deprivation.
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.
Claim(s) 1-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sherman (US 2006/0149216) in view of McCrae et al (Sleep Medicine Reviews, 2002, 5(1), 47-61).
Scope of prior art
Sherman teaches a method of treating sleep deprivation comprising inducing sleep in the patient by administering to said patient propofol. Propofol is administered for a time sufficient to induce NREM sleep stages 3 and 4 for a predetermined period of time after which administration of propofol is stopped (paragraphs [0014], [0015], [0018]). Sherman teaches IV administration of propofol ([0025]). Sherman also teaches role of a medical professional in reviewing the patient’s medical history ([0058]) as well as in administration of propofol and subsequent monitoring ([0061]). Art teaches providing facilities for person being treated including a recliner for the subject to sleep in as well providing time for the subject to get comfortable ([0058]).
Ascertaining the difference
Sherman teaches treating sleep depravation in subjects with and without a sleep disorder (paragraph [0014]), but does not teach treatment of secondary insomnia caused by sleep deprivation.
Sherman teaches administration for a time period sufficient to induce NREM stage 3 and stage 4 sleep, but fails to say that the time period is 40min.
Sherman teaches administration via IVF, but does not recite “slow infusion”, “slow injection technique” or “intermittent bolus administration”
Sherman does not specify how long it takes to perform consultation with the subject (claim 3) or how long it takes for a subject to become comfortable in the sleep quarters (claim 6).
Secondary reference
McCrae teaches that treatment of secondary insomnia is generally directed at the primary disorder (page 50, column 1, last paragraph).
Obviousness
A person of ordinary skill in the art, prior to the earliest effective filing date of the present application, would have found it obvious to treat secondary refractory chronic insomnia where the primary disorder is sleep deprivation by administering to a subject propofol.
McCrae teaches that secondary insomnia is treated by addressing the primary disorder. In the current claims, the primary disorder is sleep deprivation. It would have been obvious to treat sleep deprivation with an expectation that by treating sleep deprivation the subject would realize relief from secondary insomnia. While McCrae does not recite a method of treating sleep deprivation via administration of propofol, Sherman teaches that sleep deprivation can be treated by administration of propofol.
Regarding the specific parameters of propofol administration.
While Sherman teaches administration of propofol for a time period sufficient to induce NREM sleep, Sherman does not recite 40min of administration. Sherman also teaches monitoring the subject during the procedure in order to assess different sleep stages. It would have been obvious for a skilled artisan to determine the duration of propofol administration based on the dose administered and on the results of the patient monitoring.
Regarding technique used to administer propofol, Sherman teaches IV administration over a time period. The techniques recited by applicant, specifically slow infusion, slow injection and intermittent bolus administration are all methods of slowly administrating an agent over a time period using IV administration and all are well known to be utilized in administration of propofol. A person of ordinary skill would have found it obvious to select a well-known technique for administering propofol. Applicants can over come this rejection by a showing of unexpected result derived from a method by which propofol is administered.
References made of record but not relied upon
Xu et al., Cell Bochem Biophys, 2011, 60, 161-166.
Conclusion
Claims 1-13 are pending
Claims 1-13 are rejected
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YEVGENY VALENROD whose telephone number is (571)272-9049. The examiner can normally be reached Mon-Fri 9am-5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L Clark can be reached at 571-272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/YEVGENY VALENROD/Primary Examiner, Art Unit 1628