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 .
Election/Restrictions
Applicant’s election without traverse of Invention I (claims 1-9) in the reply filed on 20 June 2025 is acknowledged.
Claims 10-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 20 June 2025.
Claims 1-9 are under current consideration.
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 3-4 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.
Regarding claims 3-4, percentages are recited without indication of whether the percentages are based on weight or volume or other basis. Therefore, the resulting claims do not clearly set forth the metes and bounds of the patent protection desired. For purposes of compact prosecution, in this Office action the percentages are interpreted as being based on weight.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-3 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bell (US 2003/0124201 A1; published 03 July 2003; of record).
Bell discloses a method for treating psychiatric disorder such as mania or depression in patients, and treating mania or depression in patients with a bipolar disorder, by providing substantially isotopically pure heavy water substantially free of protons, or isotopically pure hydrogen-containing water substantially free of deuterium, or mixtures thereof, to the patient (abstract) wherein a method of treating a depressive or manic symptom in a human patient comprises administering isotopically pure heavy water substantially free of protons to the patient in an amount which reduces the manic or depressive symptoms of the patient (i.e., a dose) (paragraph [0016]) wherein a therapeutically effective amount means those amounts which have been determined to provide the desired psychiatric effect without side effects that are considered clinically unacceptable (paragraph [0028]) wherein heavy water is deuterium oxide (paragraph [0006]) wherein it is noted that natural, normally consumable water contains about 0.5% D2O (paragraph [0027]) wherein manic depression or bipolar disorder causes alternating periods of mania with shortened circadian rhythm and periods of depression with lengthened circadian rhythm (paragraph [0032]) wherein human circadian rhythm for manics has lengthened sleep cycle (i.e., circadian rhythm sleep disorder) which is shortened by administering deuterated compounds to a patient suffering from mania and wherein human circadian rhythm for depressives has shortened sleep cycle (i.e., circadian rhythm sleep disorder) which is lengthened by administering deuterium-free compounds to a patient suffering from depression (paragraph [0038]).
Regarding claim 3, the dose of Bell as discussed above necessarily has between about 0.5% (i.e., natural, normally consumable water) and about 100% deuterium oxide (i.e., substantially free of protons), which lies within the claimed range of about 0.05% to about 100%.
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) 1-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bell.
Bell discloses a method for treating psychiatric disorder such as mania or depression in patients, and treating mania or depression in patients with a bipolar disorder, by providing substantially isotopically pure heavy water substantially free of protons, or isotopically pure hydrogen-containing water substantially free of deuterium, or mixtures thereof, to the patient (abstract) wherein a method of treating a depressive or manic symptom in a human patient comprises administering isotopically pure heavy water substantially free of protons to the patient in an amount which reduces the manic or depressive symptoms of the patient (i.e., a dose) (paragraph [0016]) wherein a therapeutically effective amount means those amounts which have been determined to provide the desired psychiatric effect without side effects that are considered clinically unacceptable (paragraph [0028]) wherein heavy water is deuterium oxide (paragraph [0006]) wherein it is noted that natural, normally consumable water contains about 0.5% D2O (paragraph [0027]) wherein manic depression or bipolar disorder causes alternating periods of mania with shortened circadian rhythm and periods of depression with lengthened circadian rhythm (paragraph [0032]) wherein human circadian rhythm for manics has lengthened sleep cycle (i.e., circadian rhythm sleep disorder) which is shortened by administering deuterated compounds to a patient suffering from mania and wherein human circadian rhythm for depressives has shortened sleep cycle (i.e., circadian rhythm sleep disorder) which is lengthened by administering deuterium-free compounds to a patient suffering from depression (paragraph [0038]).
Regarding claim 3, the dose of Bell as discussed above necessarily has between about 0.5% (i.e., natural, normally consumable water) and about 100% deuterium oxide (i.e., substantially free of protons), which lies within the claimed range of about 0.05% to about 100%.
Regarding claim 4, the dose of Bell as discussed above necessarily has between about 0.5% (i.e., natural, normally consumable water) and about 100% deuterium oxide (i.e., substantially free of protons), which overlaps the claimed range of about 0.1% to about 15%, and a prima facie case of obviousness exists where prior art and claimed ranges overlap per MPEP 2144.05(I).
Regarding claims 5-8, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to optimize the effectiveness of the treatment method of Bell as discussed above by varying the dosage of deuterium oxide active agent administered to the patient in the method of Bell as discussed above, with a reasonable expectation of success, given that optimization of active agent dosage is obvious. See, e.g., Ex parte Belder, USPTO, BPAI Final Decision, Appeal 2007-0185, Application 10/305,281, pages *7-*8 ("obvious to optimize the amount of drug in a tablet"; "A minor modification of the prior art, such as optimizing the amount of a particular ingredient, does not distinguish the claimed product from the prior art."; "experimentation needed to arrive at a drug dosage 'was nothing more than routine.'").
Claim(s) 1-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bell as applied to claims 1-8 above, and further in view of Furey et al. (US 2006/0270698 A1; published 30 November 2006).
Bell is relied upon as discussed above.
Bell does not disclose scopolamine as in claim 9.
Furey et al. discloses scopolamine for the treatment of depression (title) wherein other psychoactive agents may be included therewith wherein a "psychoactive agent" is an agent or drug that affects the mind, emotional state or behavior of a subject (abstract; paragraph [0077]) wherein other neuropsychiatric diseases can be treated therewith such as treatment-resistant major depressive disorder or depressed phase of bipolar disorder (paragraph [0079]) wherein an effective daily dose can be administered (paragraph [0064]) wherein a pharmaceutical formulation can include additional active ingredients (paragraph [0067]).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Bell and Furey et al. by combining the dose of scopolamine of Furey et al. with the dose and method of Bell, with a reasonable expectation of success. A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to do so to more effectively treat depression or bipolar disorder by including in the method of Bell another active ingredient effective therefor, given that combination of equivalents known for the same purpose (i.e., active ingredients for treating depression or bipolar disorder such as deuterium oxide and scopolamine) are prima facie obvious per MPEP 2144.06(I).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL B. PALLAY whose telephone number is (571)270-3473. The examiner can normally be reached Monday through Friday from 8:30 AM to 5:00 PM Eastern Time.
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/MICHAEL B. PALLAY/Primary Examiner, Art Unit 1617