DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Withdrawn Rejections:
Applicant's amendments and arguments filed on 01/07/2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Any rejection and/or objection not specifically addressed below is herein withdrawn.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
Claims 1-16 are pending and under examination.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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 1-16 are rejected under 35 U.S.C. 103(a) as being unpatentable over Noritaka et al. (JP2007291071, Google Translation) in view of Hendricks et al. (US6387907), Holistic (“Alternative and integral Therapies for Insomnia”, 04/16/2010, retrieved from https://web.archive.org/web/20100416092326/http://www.holistic-online.com/Remedies/Sleep/sleep_ins_nutrition.htm; cited in IDS), Cohen (US20050059701), Stein (US20090092687) and Burnett et al. (US6664273).
Determination of the scope and content of the prior art
(MPEP 2141.01)
Noritaka et al. teaches a pharmaceutical composition for hypnosis, treatment of sleep disorders or sleep improvement, comprising an antihistamine and one or more selected from the following group. Group: Spruce or its extract, Scarlet or its extract, Keihi or its extract, Keishi or its extract, Keihei or its extract, Chimpi or its extract, Spruce or its extract, Ogon or its extract, Sojutsu or its extract and Ginkgo biloba or its extract , and the composition is in the form of tablet, liquid or granule (claims 1 and 14). In one embodiment, the antihistamine is doxylamine as well as pharmaceutically acceptable salt such as inorganic and organic acid salt (page 3, 2nd paragraph), and the dose of antihistamine is from 10 to 300 mg per day, preferably 25 to 100mg (page 3, 6th paragraph). Thus, the dose of doxylamine for one daily tablet is 10 mg to 300mg, and twice daily is 5 mg to 150 mg by simple calculation. The formulation may include additional additives. Formulation additives include, for example, excipients, bases, disintegrants, binders, lubricants, coating agents, fluidizers, plasticizers, surfactants, enablers, buffers, solubilizers, dissolution agents Adjuvants, solvents, stabilizers, emulsifiers, suspending agents, dispersants, antioxidants, fillers, thickeners, thickeners, pH regulators, preservatives, preservatives, sweeteners, flavoring agents, Examples thereof include a refreshing agent, a flavoring agent / fragrance, a fragrance, and a coloring agent. These formulation additives may be used alone or in combination of two or more (page 4, 1st paragraph)
Hendricks et al. teaches compositions for alleviating or preventing a disordered breathing episode. The composition of the invention comprises a serotonin re-uptake inhibitor, a TRH agonist and an agent selected from the group consisting of a serotonin precursor and a serotonin agonist (abstract). In another embodiment of the composition of the invention, the serotonin precursor is selected from the group consisting of L-tryptophan and L-5-hydroxytryptophan (column 3, line 1-5). The pharmaceutical compositions useful for practicing the invention may be administered to deliver a dose of each component of the composition of the invention between 1 ng/kg/day and 100 mg/kg/day (column 7, line 7-12). Thus, when dose is 1 mg/kg/day, for a 70kg adult, the dose per day is 70mg for L-tryptophan or L-5-hydroxytryptophan. In one embodiment of this method, the mammal is afflicted with a condition associated with a disordered breathing episode, such as one selected from the group consisting of hypersomnolence, snoring, hypopneas, apneas, obstructive sleep apnea, sleep hypopnea syndrome, upper airway resistance syndrome, and severe snoring conditions associated with arousal from sleep. Preferably the mammal is a human (column 3, line 54-61). The pharmaceutical composition includes oral solid formulation or other similar formulation (column 7, [line 12-24).
Holistic teaches Deficiencies in certain vitamins, minerals, amino acids and enzymes may disrupt sleep. Calcium, magnesium, B vitamins, folic acid and melatonin deficiencies may impair sleep. Calcium (1500-2000mg daily), especially when contained in food, has a sedative effect on the body. A calcium deficiency in the body causes restlessness and wakefulness; Magnesium, in doses of approximately 250 milligrams, can help induce sleep. Magnesium deficiency is responsible for nervousness that prevents sleep; The B vitamins are known to have a sedative effect on the nerves, Vitamin B6 can help to prevent insomnia. L-tryptophan is converted into serotonin, a natural sleep-inducing chemical. It also enhances the brain’s ability to produce melatonin, the hormone that regulates your body’s natural inner clock. It is important to maintain adequate levels of vitamin B., niacin (100mg daily) and magnesium when using 5-HTP, as these nutrients serve as essential cofactors in the conversion of 5-hydroxytryptophan (5-HTP) to serotonin; 5-HTP increase deep-sleep and is more effective than tryptophan. Melatonin (1.5mg -8mg daily) is a hormone secreted naturally by the pineal gland. Melatonin is the sleep hormone. It is said to induce sleep without any negative side effects. Melatonin is secreted mainly at night.
Cohen teaches a stable paroxetine hydrochloride tablet comprising paroxetine hydrochloride (abstract). The tablet includes disintegrants such as microcrystalline cellulose, sodium starch glycolate ([0026]), lubricants magnesium stearate ([0027]). In example 1, the tablet includes dibasic calcium phosphate as filler, sodium starch glycolate as disintegrant and magnesium stearate as lubricants ([0043]). Coloring agent may also be included ([0029]).
Stein teaches methods and compositions for maintaining a state of sexual wellness in a healthy human by providing a dietary supplement comprising one or more sexual steroid prohormones (abstract). In one example, FD& C Blue #1 Aluminum Lake is included as inactive ingredient in a tablet ([0047]).
Burnett et al. teaches ovel antagonists for melanin-concentrating hormone (abstract) and method of treating sleep apnea (column 14, line 5-15). The actual dosage employed may be varied depending upon the requirements of the patient and the Severity of the condition being treated. Determination of the proper dosage regimen for a particular Situation is within the Skill of the art. For convenience, the total daily dosage may be divided and administered in portions during the day as required. The amount and frequency of administration of the compounds of the invention and/or the pharmaceutically accept able Salts thereof will be regulated according to the judgment of the attending clinician considering Such factors as age, condition and Size of the patient as well as Severity of the Symptoms being treated (column 24, line 25-40).
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02)
The difference between the instant application and Noritaka et al. is that Noritaka et al. does not expressly teach L-tryptophan, 5-hydroxytryptophan, melatonin, vitamin B6, dicalcium phosphate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate, FD& C Blue #1 Aluminum Lake; this deficiency in Noritaka et al. is cured by the teachings of Hendricks et al., Holistic, Cohen and Stein.
Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
It would have been obvious to one of ordinary skill in the art at the time the claimed invention was made to modify the invention of Noritaka et al., as suggested by Hendricks et al., Holistic, Cohen and Stein, and produce the instant invention.
One of ordinary skill in the art would have been motivated to include composition comprising L-tryptophan and L-5-hydroxytryptophan in the composition comprising doxylamine to treat sleep breath disorder such as sleep apnea because Hendricks et al. teaches composition comprising L-tryptophan and L-5-hydroxytryptophan as serotonin precursor for the treatment of sleep breath disorder such as sleep apnea and "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). Furthermore, both of L-tryptophan and L-5-hydroxytryptophan are useful for sleep as suggested by Holistic. Therefore, it is obvious for one of ordinary skill in the art to include composition comprising L-tryptophan and L-5 hydroxytryptophan in the composition comprising doxylamine succinate of and produce instant claimed invention with reasonable expectation of success.
One of ordinary skill in the art would have been motivated to include melatonin and vitamin B6 because they are suitable ingredient as sleep aid as suggested by Holistic. Therefore, it is obvious for one of ordinary skill in the art to include melatonin and vitamin B6, and produce instant claimed invention with reasonable expectation of success. MPEP 2144.07.
One of ordinary skill in the art would have been motivated to include additional pharmaceutically acceptable ingredients dicalcium phosphate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate because they are suitable ingredients for tablets. MPEP 2144.07. Under guidance from Noritaka et al. teaching pharmaceutically acceptable ingredients disintergrants, fillers and lubricants; Cohen teaching microcrystalline cellulose and sodium starch glycolate as disintegrants, magnesium stearate as lubricants and dibasic calcium phosphate (dicalcium phosphate) as filler; it is obvious for one of ordinary skill in the art to include additional pharmaceutically acceptable ingredients dicalcium phosphate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate and produce instant claimed invention with reasonable expectation of success.
One of ordinary skill in the art would have been motivated to include FD& C Blue #1 Aluminum Lake because FD& C Blue #1 Aluminum Lake is a suitable color agent in pharmaceutical composition such as tablet. MPEP 2144.07. Under guidance from Noritaka et al. teaching coloring agent, Stein teaching FD& C Blue #1 Aluminum Lake (known as color agent), it is obvious for one of ordinary skill in the art to include FD& C Blue #1 Aluminum Lake and produce instant claimed invention with reasonable expectation of success.
Regarding claims 1-3, 8-11 prior arts teach a method of treating sleep disorder by administering a tablet comprising doxylamine (compound of formula I) at 5 mg to 150 mg; L-tryptophan (compound of formula II) at 70mg, 5-hydroxytryptophan (compound of formula III) at 70 mg and melatonin (compound of formula IV) at 1.5mg -8mg.
Regarding claim 4 and 12, the dosage in prior arts is generally for adults being no indication otherwise, and typically weight of adult is 70kg. Furthermore, since dosage is in the range, there is no substantially change whether the wight of adults is 50kg or 70kg.
Regarding claim 6 and 14, regarding daily adjustment of dosage and duration of treatment, it is within skill of artisan to adjust based on weight, age, gender and medical condition as suggested Burnett et al., and it is advantage to adjust dosage daily to meet variable situation of patients each day. There is no requirement for this adjustment based on duration of treatment, it is obvious to continue the treatment according to need of patient, thus, it is obvious.
Regarding claims 7 and 15, prior arts teach vitamin B6 (pyridoxime).
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Argument:
Applicants argue that there is no teaching what is concern of the application, no analogous art, no certain properties such as sedative. All arguments are incorporated herein by reference.
In response to this argument: this is no persuasive. In response to applicant's argument that no teaching of what the invention concerns, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). In response to applicant's argument that 2nd reference is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, each of 2nd reference are art related for breath and or sleep disorder, thus, they are in fact analogous art. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., sedative effect) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Therefore, the 103 rejection is still proper.
MPEP 2141 III states: “The proper analysis is whether the claimed invention would have been obvious to one of ordinary skill in the art after consideration of all the facts.” Respectfully, after weighing all the evidence, the Examiner has reached a determination that the instant claims are not patentable in view of the preponderance of evidence and consideration of all the facts which is more convincing than the evidence which has been offered in opposition to it.
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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-4, 7-9 of US patent 11224603 (reference patent) in view of Hendricks et al. (US6387907), Holistic (“Alternative and integral Therapies for Insomnia”, 04/16/2010, retrieved from https://web.archive.org/web/20100416092326/http://www.holistic-online.com/Remedies/Sleep/sleep_ins_nutrition.htm; cited in IDS), Cohen (US20050059701), Stein (US20090092687) and Burnett et al. (US6664273). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference patent teaches doxylamine or salt at an amount of 1mg to 50mg in view of Hendricks et al. teaching 70mg of L-tryptophan, 70mg of L-5-hydroxytryptophan, Holistic teaching melatonin and vitamin B6, Cohen teaching coloring agent, dicalcium phosphate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate; Stein teaching FD& C Blue #1 Aluminum Lake; Burnett et al. teaches daily adjustment of dosage; thus, one artisan in the art would immediately recognize the obvious variant of applicant’s claimed invention over reference patent.
Claims 1-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of US patent 9700548 (reference patent) in view of Noritaka et al. (JP2007291071, Google Translation), Hendricks et al. (US6387907), Holistic (“Alternative and integral Therapies for Insomnia”, 04/16/2010, retrieved from https://web.archive.org/web/20100416092326/http://www.holistic-online.com/Remedies/Sleep/sleep_ins_nutrition.htm; cited in IDS) and Cohen (US20050059701) and Stein (US20090092687) and Burnett et al. (US6664273). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference patent teaches doxylamine or salt in view of Noritaka et al. teaching the dose of doxylamine for one daily tablet is 10 mg to 300mg; Hendricks et al. teaching 70mg of L-tryptophan, 70mg of L-5-hydroxytryptophan, Holistic teaching melatonin and vitamin B6, Cohen teaching coloring agent, dicalcium phosphate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate; Stein teaching FD& C Blue #1 Aluminum Lake; Burnett et al. teaches daily adjustment of dosage; thus, one artisan in the art would immediately recognize the obvious variant of applicant’s claimed invention over reference patent.
Claims 1-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-31 of US patent 10682343 (reference patent) in view of Hendricks et al. (US6387907), Cohen (US20050059701) and Stein (US20090092687) and Burnett et al. (US6664273). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference patent teaches doxylamine or salt at an amount of 1mg to 50mg and melatonin; in view of Hendricks et al. teaching 70mg of L-tryptophan, 70mg of L-5-hydroxytryptophan, and Cohen teaching coloring agent, dicalcium phosphate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate; Stein teaching FD& C Blue #1 Aluminum Lake; Burnett et al. teaches daily adjustment of dosage; thus, one artisan in the art would immediately recognize the obvious variant of applicant’s claimed invention over reference patent.
Response to Argument:
Applicants argue that double patent rejection be held for abeyance.
In response to this argument: this is not persuasive. Since no TD is filed, the double patent rejections are maintained for record.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JIANFENG SONG. Ph.D. whose telephone number is (571)270-1978. The examiner can normally be reached M-F 8-5.
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/JIANFENG SONG/Primary Examiner, Art Unit 1613