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
STATUS OF THE CLAIMS: Claims 1-27 are pending in this application.
Election/Restrictions
Applicant's election with traverse of in the reply filed on October 15, 2025 is acknowledged, and the traversal is found persuasive. The Restriction Requirement posted on April 17, 2025 is withdrawn and claims 1-27 were examined in its entirety.
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.
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.
Claims 1-3 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Liu (US Pub. 2006/0089335).
Applicants claims the following:
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Liu teaches a method for improving wakeful function in a subject suffering from a condition associated with memory impairment, dementia, or cognitive deficit by enhancing cognitive function comprising the step of administering a composition comprising a compound that activates GABAB receptors (i.e., giving the subject an effective amount of an upregulator of GABAB signaling). Additionally, Liu discloses that the compositions comprising the compound that activates GABAB receptors can be administered for short periods of time such as days or a few weeks to provide short term enhancement of learning ability or memory. (See Abstract and pages 1-21 and specifically paragraphs [0120], [0170]).
Liu does not teach wherein the cognitive deficiency is an acquired cognitive deficiency.
It would have been obvious to one having ordinary skill in the art at the time of the invention to modify the teaching of Liu to include the condition acquired cognitive deficiency. A skilled person having ordinary skill in the art at the time of the invention would be motivated to apply the method of Liu to the subject suffering from an acquired cognitive deficiency by routine experimentation in order to examine the efficacy of the method toward various types of cognitive deficiency, especially since Liu teaches methods for improving wakeful function in a subject suffering from a condition associated with memory impairment, dementia, or cognitive deficit by enhancing cognitive function by administering a composition comprising a compound that activates GABAB receptors. Therefore, it would have been obvious to one of ordinary skill in the art, that one confronted with treating acquired cognitive deficiency, would be motivated to apply the teachings of Lui and include acquired cognitive deficiency.
Since Applicant’s claims are prima facie obvious in view of the teachings of the Liu reference, Applicant’s claims are obvious, and therefore, rejected under 35 U.S.C. 103.
Regarding claim 2, Liu teaches the method of claim 1 and discloses in the Abstract that the upregulator of GABAB signaling is baclofen as well as other agents that causes a voltage-dependent block of NMDA receptors such as divalent ions (e.g., Mg++).
Regarding claim 9, Liu teaches the method of claim 1, and discloses in the Abstract that the upregulator of GABAB signaling is baclofen as well as other agents that causes a voltage-dependent block of NMDA receptors such as divalent ions (e.g., Mg++). Baclofen comprises electrical stimulation of corticothalamic afferents, and thus, Liu teaches wherein the upregulator of GABAB signaling comprises electrical stimulation of corticothalamic afferents in the subject
Since Applicant’s claims are prima facie obvious in view of the teachings of the Liu reference, Applicant’s claims are obvious, and therefore, rejected under 35 U.S.C. 103.
Claims 1, 14-17 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Liu (US Pub. 2006/0089335) in view of Schiff et al. (US Pub. 2015/0367133).
Applicants claims the following:
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Liu teaches a method for improving wakeful function in a subject suffering from a condition associated with memory impairment, dementia, or cognitive deficit by enhancing cognitive function comprising the step of administering a composition comprising a compound that activates GABAB receptors (i.e., giving the subject an effective amount of an upregulator of GABAB signaling). Additionally, Liu discloses that the compositions comprising the compound that activates GABAB receptors can be administered for short periods of time such as days or a few weeks to provide short term enhancement of learning ability or memory. (See Abstract and pages 1-21 and specifically paragraphs [0120], [0170]).
Liu does not teach wherein the cognitive deficiency is an acquired cognitive deficiency, administering at night and in combination with administering an anterior-forebrain stimulating therapy when the subject is awake.
Schiff teaches that an impaired cognitive function can be treated by activating anterior forebrain dynamics. In paragraph [0107], Schiff discloses that the brain regions that are stimulated include intralaminar nuclei, and specifically the contromedian and perifascicular nuclei, and the conditions treated is impaired cognitive function. (See paragraph [0051]). On pages 4-11, Schiff discloses methods, devices and systems for achieving optimal control of intrathalamic dynamics and activation of anterior forebrain
dynamics using multi-site deep brain stimulation.
It would have been obvious to one having ordinary skill in the art at the time of the invention to be motivated to combine the teaching of Liu and Schiff. Liu teaches methods for improving wakeful function in a subject suffering from a condition associated with memory impairment, dementia, or cognitive deficit by enhancing cognitive function comprising the step of administering a composition comprising a compound that activates GABAB receptors (i.e., giving the subject an effective amount of an upregulator of GABAB signaling). Additionally, Liu discloses that the compositions comprising the compound that activates GABAB receptors can be administered for short periods of time such as days or a few weeks to provide short term enhancement of learning ability or memory. Schiff teaches that an impaired cognitive function can be treated by activating anterior forebrain dynamics. All the moieties are taught in the art. Therefore, one of ordinary skill in the art will be motivated to apply the activator of anterior forebrain to the method taught by Liu (i.e., method for improving wakeful function in a subject suffering from a condition associated with memory impairment, dementia, or cognitive deficit by enhancing cognitive function by giving the subject an effective amount of an upregulator of GABAB signaling) by routine experimentation in order to enhance the efficacy of the method.
Since Applicant’s claims are prima facie obvious in view of the teachings of the Liu and Schiff references, Applicant’s claims are obvious, and therefore, rejected under 35 U.S.C. 103.
Regarding claim 15, Schiff teaches the method of claim 14, wherein the anterior-forebrain stimulating therapy comprises administering a small molecule compound of noradrenaline. (See paragraphs [0114] and [0147]).
Regarding claim 16, Schiff teaches the method of claim 14, wherein the anterior-forebrain stimulating therapy is deep brain stimulation. (See paragraph [0008]).
Regarding claim 17, Schiff teaches the method according to claim 14, and Liu teaches wherein the upregulator of GABAB agonists is baclofen as well as other agents that causes a voltage-dependent block of NMDA receptors such as divalent ions (e.g., Mg++).
Regarding claim 23, Schiff teaches the method according to claim 14, and Liu teaches wherein the upregulator of GABAB signaling comprises electrical stimulation of corticothalamic afferents.
Since Applicant’s claims are prima facie obvious in view of the teachings of the Liu and Schiff references, Applicant’s claims are obvious, and therefore, rejected under 35 U.S.C. 103.
Conclusion
Claims 1-27 are pending in this application. Claims 1-27 are rejected. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL V WARD whose telephone number is (571)272-2909. The examiner can normally be reached M-F 9am to 5pm.
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/PAUL V WARD/ Primary Examiner, Art Unit 1622
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