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
This Office Action is in response to Applicant’s Arguments and Amendment filed, 08/12/2025, wherein the Amendment amended claims 1, 8, and 18, and cancelled claims 4 and 10.
Claims 1-2, 6, 8-9, 12-18 and 20 are pending.
Priority
This application claims the following priority:
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Election/Restrictions
Applicant elected Group I, the composition, in the reply filed on 01/29/2024.
Claim 20 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 1-2, 6, 8-9, and 12-18 are examined on the merits herein.
REJECTIONS WITHDRAWN
The status for each rejection and/or objection in the previous Office Action is set out below.
Claim Objections
Applicant’s amendments to claims 1, 8, and 18 are sufficient to overcome these objections.
35 U.S.C. § 112
Applicant’s deletion of claims 4 and 10 is sufficient to overcome these rejections.
REJECTIONS-NEW, MAINTAINED/SLIGHTLY MODIFIED
Applicant’s amendments to the claims have resulted in the below new and modified rejections.
Specifically, independent claim 1 has been amended to replace “glucose” with - -a high glycemic index carbohydrate- -; and independent claim 8 has been amended to replace “meal based on a combination of a plant source containing protein-bound tryptophan which is a cereal, with - -cereal plant source containing protein-bound tryptophan- -
Claim Objections
(New) Claim 1 is objected to because of the following informalities:
In claim 1, the term “of” in line 2 should be deleted.
Appropriate correction is required.
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 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.
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.
(Modified) Claims 1-2, 6, 8, and 12-18 are rejected under 35 U.S.C. 103 as being unpatentable over WO 01/89319 to Hudson (published 2001, PTO-892 of 04/19/2024) in view of Padumanonda (“Determination of melatonin content in traditional Thai herbal remedies used as sleeping aids,” DARU Jn. of Pharma. Sci., published 2014, PTO-892 of 04/19/2024), and US PG-PUB 2014/0302170 to Jones (published 2014, IDS of 02/26/2021), as evidenced by Comai (“The content of proteic and nonproteic (free and protein bound) tryptophan in quinoa and cereal flours. Food Chem, published 2007, IDS of 04/19/2024).
Hudson teaches tryptophan sources from plants and uses therefore (see title, abstract).
Compositions are described comprising at least partially defatted meal from a plant source containing protein-bound tryptophan, preferably squash seeds, and optionally a carbohydrate source. Dietary supplements, foods and beverages comprising the composition, to induce sleep, are taught (abstract).
Hudson teaches a composition comprising at least partially defatted meal from a plant source containing protein-bound tryptophan and a physiologically acceptable diluent or carrier therefore (pg. 23, claim 1).
Hudson teaches the composition as further comprising a) a carbohydrate source having a high glycemic index, wherein glucose is taught as the carbohydrate source, and b) vitamin B3, B6 and combinations thereof in an amount sufficient to enhance uptake of the tryptophan across the blood/brain barrier, wherein the protein-bound tryptophan is in an amount of 25-1000mg of tryptophan, and the glucose is in an amount of 25-200mg (pgs. 23-24, claims 5-7, 12, 14).
Regarding claim 1, while Hudson teaches a composition comprising an at least partially defatted meal from a plant source containing protein-bound tryptophan in an amount of 25-1000mg tryptophan, 25-200mg glucose, vitamin B3, B6 or combinations thereof in an amount sufficient to enhance uptake of the tryptophan across the blood/brain barrier, it differs from that of the instantly claimed invention in that it does not teach an herb containing melatonin.
Padumanonda teaches melatonin content in traditional Thai herbal remedies used as sleeping aids (see title).
Melatonin is a neuroendocrine hormone produced primarily by the pineal gland in the brain from the amino acid tryptophan, stimulated by darkness and suppressed by light. Melatonin is involved in circadian rhythm and regulation of diverse body functions, including sleep (pg. 1, 1st paragraph)
The melatonin content of the following herbs is taught:
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(pg. 3, Col. 2).
Jones ‘170 teaches a sleep promoting food formulation comprising melatonin, L-tryptophan, and an appropriate amount of high glycemic index carbohydrates (pg. 4, claim 1). Jones further teaches such formulations as comprising about 0.3 mg to less than 10 mg melatonin ([0023]).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to add an herb containing melatonin, as taught by Padumanonda, to the composition of Hudson, to arrive at instant claim 1. One of ordinary skill in the art would have been motivated to make such an addition, with a reasonable expectation of success, because:
-Hudson is directed toward supplements for promoting sleep and Padumanonda teaches herbs containing melatonin as sleep aids; and
-Jones teaches that compositions that combine melatonin and tryptophan promote sleep ([0048]) and maintain sleep for an appropriate period of time ([0033]).
As such, an ordinary skilled artisan would have been motivated to make such an addition, to predictably arrive at a composition that more effectively promotes sleeps. Moreover, combining equivalents (sleep inducing/maintaining compounds) known for the same purpose (inducing/maintaining sleep), is prima facie obvious. MPEP 2144.06
Regarding the wherein clause in the last three lines of claim 1, it is noted that this clause is directed toward the intended use of the claimed composition and does not impart a structural difference to the composition. Since the combined composition of Hudson, Padumanonda, and Jones is capable of performing the intended use, this limitation is met. Moreover, since the combined composition of Hudson, Padumanonda, and Jones teaches the instantly claimed composition, the limitation “wherein, upon ingestion, the composition enhances sleep quality and duration and decreases sleep latency in mammals without suppressing endogenous melatonin synthesis in the mammal,” is met. See MPEP 2112.01.
Regarding claim 2, Hudson teaches a partially defatted plant source as having a higher tryptophan source than the starting material (pg. 25, claim 27)
Regarding claim 6, Hudson teaches the plant source as a seed, wherein the seed is selected from the group consisting of butternut squash seed, peppercorn squash seed, pumpkin seed, lentil seed, sunflower seed, flax seed, watermelon seed, sisymbrium seed, cotton seed, sesame seed, canola seed, evening primrose seed, safflower seed, alfalfa seed, barley, soybean and combinations thereof (pg. 23, claims 2-4).
Regarding claim 8, while the combination of Hudson, Padumanonda, and Jones teaches a composition comprising an at least partially defatted meal from a plant source containing protein-bound tryptophan in an amount of 25-1000mg tryptophan, an herb containing melatonin, vitamin B3, B6 and combinations thereof in an amount sufficient to enhance uptake of the tryptophan across the blood/brain barrier, it differs from that of the instantly claimed invention in that it does not teach the plant source as a cereal.
Jones teaches that L-tryptophan can be provided by rice in its sleep promoting food formulations comprising melatonin, L-tryptophan and high glycemic index carbohydrates ([0023]-[0024], [0036]; pg. 4—claims 1&6).
As evidenced by Comai (Food Chem, published 2007, PTO-892) free and protein-bound tryptophan is found in rice (abstract, Table 1, pg. 1352).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to select rice, a cereal, as the plant source containing the protein-bound tryptophan in the combination of Hudson, Padumanonda, and Jones, to arrive at instant claim 8. One of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because:
-Jones and the combination of Hudson, Padumanonda, and Jones teaches compositions comprising plant sources of tryptophan, melatonin, and high glycemic index carbohydrates, to promote sleep, and
-Jones teaches rice as a plant source of tryptophan.
As such, an ordinary skilled artisan would have been motivated to select rice to predictably arrive at a composition comprising rice which contains protein-bound tryptophan for the promotion of sleep.
Regarding claims 12-13, Hudson teaches the composition in the form of a tablet, powder, suspension, liquid, capsule, gel, or dietary supplement (pg. 23, claims 8-9).
Regarding claim 14, Hudson teaches the supplement as formulated into a plurality of oral dosage forms for ingestion on a daily basis (pg. 23, claim 10). Regarding “for ingestion on a daily basis,” this limitation is an intended use that does not impart a structural limitation to the claim. Since the combined composition of Hudson, Padumanonda, and Jones is capable of performing the intended use, this limitation is met. See also MPEP 2112.01.
Regarding claim 15, Hudson teaches the dietary supplements as formulated as powders for mixing with consumable liquids, such as milk, juice, water or consumable gels or syrups (pg. 7, lines 14-22).
Regarding claim 16, Hudson teaches partially defatted butternut squash seed meal as preferable seed (pg. 23-24, claims 12-13).
Regarding claim 17, Hudson teaches 25-50mg tryptophan and 75-100mg glucose (pg. 24, claim 13), Jones teaches melatonin as comprising about 0.3mg to less than 10mg melatonin in compositions comprising tryptophan and melatonin, and in the case where the claimed ranges “overlap or lie inside ranges disclosed in the prior art” a prima facie case of obviousness exists. See MPEP 2144.05. Moreover, the optimization of known percent amounts for known active agents is considered well within the competence level of an artisan of ordinary skill in the pharmaceutical sciences. It has been held that the selection of optimal parameters, such as amounts of active agents, to achieve a beneficial effect, is within the skill in the art of an ordinary artisan. See In re Boesch, 205 USPT 215 (CCPA 1980) and MPEP 2144.05.
Regarding claim 18, Hudson teaches its compositions as comprising from about 5-50mg vitamin B3, 0.5-50mg vitamin B6 and combinations thereof (pg. 24, claim 14).
Claims 1-2, 6, 8, and 12-18 are rendered obvious.
(Modified) Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over WO 01/89319 to Hudson (published 2001, PTO-892 of 04/19/2024), Padumanonda (“Determination of melatonin content in traditional Thai herbal remedies used as sleeping aids,” DARU Jn. of Pharma. Sci., published 2014, PTO-892 of 04/19/2024), and US PG-PUB 2014/0302170 to Jones (published 2014, IDS of 02/26/2021), as evidenced by Comai (“The content of proteic and nonproteic (free and protein bound) tryptophan in quinoa and cereal flours. Food Chem., published 2007, IDS of 04/19/2024), as applied to claims 1-2, 6, 8, and 12-18, above and further in view of Thanuja (“Role of Black Rice in Health and Diseases,” Internat’l Jn. of Health Sciences and Research, published 02/2018, PTO-892 of 04/19/2024).
Hudson, Padumanonda, Jones, and Comai are applied as discussed above and incorporated herein.
While the combination of Hudson, Padumanonda, and Jones a composition comprising an at least partially defatted meal from rice containing protein-bound tryptophan, an herb containing melatonin, and vitamin B3, B6 and combinations thereof in an amount sufficient to enhance uptake of the tryptophan across the blood/brain barrier, it differs from that of the instantly claimed invention in that it does not teach the species of rice recited in instant claim 9.
Thanuja teaches black rice as a functional food with health benefits (abstract).
Black rice contains tryptophan (abstract, pg. 241, 2nd full paragraph).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to select the black rice of Thanuja as the rice in the combination of Hudson, Padumanonda and Jones, to arrive at instant claim 9. One of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because the combination of Hudson, Padumanonda, and Jones teaches tryptophan as derived from rice, and Thanuja teaches black rice as a species of rice which contains tryptophan.
As such, an ordinary skilled artisan would have been motivated to select black rice as the rice in the combination of Hudson, Padumanonda and Jones, to predictably arrive at a rice source containing protein-bound tryptophan that is effective to promote sleep.
Response to Arguments
On pgs. 5-6, Remarks, Applicant argues that Comai concludes that protein-bound tryptophan cannot cross the blood brain barrier, which directly contradicts the teachings of the present invention and therefore teaches away from the present invention.
This argument has been fully considered, but is not found persuasive. It is respectfully pointed out that Comai is relied upon, in reference to claim 8, as an evidentiary reference teaching that free and protein-bound tryptophan are in rice. As such, Comai is relied upon merely to show that the tryptophan in the rice of Jones comprises both free and protein-bound tryptophan, thus meeting the limitation of “cereal plant source containing protein-bound tryptophan.” Moreover, the instant claims are product claims and not method of use claims that require a step of administering, to a subject, the instantly claimed composition. In arguing the “blood-brain barrier,” it appears that Applicant may be arguing an intended use of the instantly claimed composition. However, such a use is not even recited in the claims. The only reference to the blood-brain barrier in reference to tryptophan is found in [0011] and [0018] of the specification, “The composition also preferably contains a carbohydrate source, such as glucose, in an amount sufficient to facilitate the transport of tryptophan across the blood-brain barrier” and “It has been found that glucose facilitates the transport of tryptophan across the blood-brain barrier.” Since the above rejection, in reference to claim 8, teaches a composition comprising “cereal plant source containing protein-bound tryptophan,” and glucose, even if this limitation was recited as an intended use, then the combined composition of Hudson, Padumanonda, and Jones, would meet this limitation. Applicant is respectfully reminded that the intended use of a claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art composition is capable of performing the intended use, then it meets the claim.
On pg. 6, Remarks, Applicant argues that Jones teaches the use of L-tryptophan, which is the free amine form of tryptophan and that the present invention uses a natural, amide-bound tryptophan, distinct both chemically and functionally.
This argument has been fully considered, but is not found persuasive. It is respectfully pointed out that this argument is also directed toward instant claim 8. However, instant claim 8 does not recite an amide-bound tryptophan but recites “cereal plant source containing protein-bound tryptophan.” As such, instant claim 8 is not limited to an “amide-bound tryptophan.” Regarding Jones, Jones teaches a sleep promoting food formulation comprising melatonin, L-tryptophan, and an appropriate amount of high glycemic index carbohydrates (pg. 4, claim 1), and further teaches that L-tryptophan can be provided by rice in its sleep promoting food formulations ([0023]-[0024], [0036]; pg. 4—claims 1&6), and as evidenced by Comai, rice comprises both free and protein-bound tryptophan. Specifically in [0024] and claim 6, Jones states “L-tryptophan may be provided in a food selected from the group consisting of. . .rices.” Thus, the rice used by Jones in its formulations would have both free tryptophan and protein-bound tryptophan.
Thus, it would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to select rice, a cereal, as the plant source containing the protein-bound tryptophan in the combination of Hudson, Padumanonda, and Jones, to arrive at instant claim 8. One of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because:
-Jones and the combination of Hudson, Padumanonda, and Jones teaches compositions comprising plant sources of tryptophan, melatonin, and high glycemic index carbohydrates, to promote sleep, and
-Jones teaches rice as a plant source of tryptophan.
As such, an ordinary skilled artisan would have been motivated to select rice to predictably arrive at a composition comprising rice which contains protein-bound tryptophan for the promotion of sleep.
At the end of Remarks, pg. 6-7, it appears that Applicant is arguing that its compositions have an unexpected result in reference to the levels of tryptophan in the brain and blood. Applicant further argues that its invention overcomes “a paradox where blood tryptophan rises but brain levels fall” by providing partially defatted seed meal, high glycemic index carbohydrate, and vitamins B3 and B6.
This argument has been fully considered. However, Applicant has provided no data substantiating such a result. The arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965). Examples of attorney statements which are not evidence and which must be supported by an appropriate affidavit or declaration include statements regarding unexpected results, commercial success, solution of a long-felt need, inoperability of the prior art, invention before the date of the reference, and allegations that the author(s) of the prior art derived the disclosed subject matter from the inventor or at least one joint inventor. See MPEP 716.01(c).
Regarding the partially defatted seed meal, high glycemic index carbohydrate, and vitamins B3 and B6, it is noted that the primary reference, WO 01/89319, which is Applicant’s own work teaches compositions comprising these three components. Moreover, in just the Abstract of WO 01/89319, it is recited that “Compositions are described comprising at least partially defatted meal from a plant source containing protein-bound tryptophan. . .and optionally, a carbohydrate source provided in an amount capable of facilitating transport of in vivo generated tryptophan across the blood brain barrier.” As such, it does not appear that this is an unexpected result since the composition of WO 01/89319 already teaches that its compositions are known to facilitate the transport of protein-bound tryptophan across the blood-brain barrier.
On pg. 7, Remarks, Applicant argues that the present invention is distinct from Jones and Padumanonda because Jones uses rice as a source of L-tryptophan and melatonin, but rice only contains ~0.03% tryptophan and includes high levels of other LNAAs, and because Padumanonda identifies trace amounts of melatonin in herbs, but these would require consumption of kilograms of herbal material to reach effective dosage as recited in instant claim 1.
This argument has been fully considered, but is not found persuasive. Regarding melatonin in independent claims 1 and 8, these claims recite “an herb containing melatonin.” As such, neither claim requires any specific amount of melatonin. It is additionally pointed out that neither claim recites melatonin for use as a singular component, but the composition recites “an herb comprising melatonin.”
Padumanonda is a secondary reference which teaches herbs known in the art to contain melatonin and further teaches that these herbs containing melatonin are known for use as sleep aids.
In claim 1, Jones is relied upon as a secondary reference teaching that it is known in the art to combine both melatonin and tryptophan to promote sleep.
As such, it would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to add an herb containing melatonin, as taught by Padumanonda, to the composition of Hudson, to arrive at instant claim 1. One of ordinary skill in the art would have been motivated to make such an addition, with a reasonable expectation of success, because:
-Hudson is directed toward supplements for promoting sleep and Padumanonda teaches herbs containing melatonin as sleep aids; and
-Jones teaches that compositions that combine melatonin and tryptophan promote sleep ([0048]) and maintain sleep for an appropriate period of time ([0033]).
As such, an ordinary skilled artisan would have been motivated to make such an addition, to predictably arrive at a composition that more effectively promotes sleeps. Moreover, combining equivalents (sleep inducing/maintaining compounds) known for the same purpose (inducing/maintaining sleep), is prima facie obvious. MPEP 2144.06
Regarding claim 8, the claim recites “cereal plant source containing protein-bound tryptophan.” Claim 8 does not recite any specific amounts of the “plant source containing protein-bound tryptophan.” Moreover, in a dependent claim, Applicant recites the “cereal plant source containing protein-bound tryptophan,” as rice. It is not clear how Applicant can argue that rice does not contain a sufficient amount of tryptophan for its inventive composition, when the rice is instantly claimed as a “plant source containing protein-bound tryptophan which is a cereal,” in claim 9, and when the example in [0023] of the instant specification exemplifies “rice starch.”
On pgs. 7-8, Remarks, Applicant argues that “The present invention utilizes low-dose (0.2 mg) melatonin from edible herbs,” and then argues “1 mg of melatonin is within the range specified in Jones and not claimed in the composition of the present invention.”
This argument has been fully considered, but is not found persuasive. The instant claims are not limited to any amount of melatonin. Moreover, the instant specification does not teach “low-dose (0.2 mg) melatonin from edible herbs.”
On pg. 8, Remarks, Applicant argues that unexpected results have been achieved.
This argument has been fully considered, but is not found persuasive. Applicant is reminded that unexpected results require data/evidence, and a) are greater than expected results, b) show superiority of a property shared with the prior art, c) exhibit the presence of an unexpected property, and/or d) exhibit the absence of an expected property, and must be commensurate in scope with the claimed invention and provide a comparison with the closest prior art (MPEP 716.02).
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.
(Modified) Claims 1-2, 6, and 12-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 6,503,543 (published 2003, PTO-829) in view of Padumanonda (“Determination of melatonin content in traditional Thai herbal remedies used as sleeping aids,” DARU Jn of Pharma Sci, published 2014, PTO-892 of 04/19/2024), and US 2014/0302170 to Jones (published 2014, IDS of 02/26/2021)
Although the claims at issue are not identical, they are not patentably distinct from each other.
‘543 claims a composition comprising partially defatted meal from a plant source naturally containing tryptophan, an added carbohydrate source having a high glycemic index present in the composition in an amount sufficient to facilitate transport of tryptophan across the blood brain barrier in an individual, and a physiologically acceptable vehicle, wherein the plant source is a butternut squash seed providing 25-1000mg tryptophan, and wherein the plant source has been processed to partially remove oil contained therein to yield a natural source of tryptophan greater than its parent plan source (claim 1).
‘543 claims the composition in the form of a tablet, powder, suspension, liquid, capsule or gel form (claim 2).
‘543 claims a dietary supplement (claim 3), wherein the supplement is formulated into a plurality of oral dosage forms for ingestion on a daily basis (claim 4).
‘543 claims a composition comprising at least partially defatted butternut squash seed meal providing from about 250-1000mg or 25-50mg tryptophan, 25-200mg or 75-100mg glucose and a vehicle (claims 6-7).
‘543 claims the composition further comprising 5-50mg vitamin B3, 0.5-50mg vitamin B6 and combinations thereof (claim 8).
‘543 claims the composition as a beverage (claim 9).
While ‘543 teaches a composition comprising partially defatted meal from a plant source naturally containing 25-1000 mg tryptophan, 25-200mg glucose, vitamin B3, B6 or combinations thereof, and a carrier, it differs from that of the instantly claimed invention in that it does not teach an herb containing melatonin.
Padumanonda teaches melatonin content in traditional Thai herbal remedies used as sleeping aids (see title).
Melatonin is a neuroendocrine hormone produced primarily by the pineal gland in the brain from the amino acid tryptophan, stimulated by darkness and suppressed by light. Melatonin is involved in circadian rhythm and regulation of diverse body functions, including sleep (pg. 1, 1st paragraph)
The melatonin content of the following herbs is taught:
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(pg. 3, Col. 2).
Jones ‘170 teaches a sleep promoting food formulation comprising melatonin, L-tryptophan, and an appropriate amount of high glycemic index carbohydrates (pg. 4, claim 1). Jones further teaches such formulations as comprising about 0.3 mg to less than 10 mg melatonin ([0023]).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to add an herb containing melatonin, as taught by Padumanonda, to the composition of ‘543, to arrive at the instantly claimed invention. One of ordinary skill in the art would have been motivated to make such an addition, with a reasonable expectation of success, because:
-Jones teaches compositions that combine ~0.3 to ~10 mg melatonin and tryptophan for promoting sleep ([0048]) and maintaining sleep for an appropriate period of time ([0033]), and
--Padumanonda teaches herbs containing melatonin as sleep aids.
As such, an ordinary skilled artisan would have been motivated to make such an addition, to predictably arrive at a composition that promotes sleeps.
Regarding the wherein clause in the last three lines of claim 1, it is noted that this clause is directed toward the intended use of the claimed composition and does not impart a structural difference to the composition. Since the combined composition of ‘543, Padumanonda, and Jones is capable of performing the intended use, this limitation is met. Moreover, since the combined composition of ‘543, Padumanonda, and Jones teaches the instantly claimed composition, the limitation “wherein, upon ingestion, the composition enhances sleep quality and
duration and decreases sleep latency in mammals without suppressing endogenous melatonin synthesis in the mammal,” recited in instant claims 1, is met. See MPEP 2112.01. (Modified)
Claims 1-2, 6, 12-14, and 16-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 6,656,473 (published 2003, PTO-829) in view of Padumanonda (“Determination of melatonin content in traditional
Thai herbal remedies used as sleeping aids,” DARU Jn of Pharma Sci, published 2014, PTO-892 of 04/19/2024), and US 2014/0302170 to Jones (published 2014, IDS of 02/26/2021)
Although the claims at issue are not identical, they are not patentably distinct from each other.
‘473 claims a method of inducing sleep in a human by administering a composition comprising partially defatted meal from a plant source naturally containing tryptophan, 25-200mg glucose and a physiologically acceptable vehicle, wherein the plant source is a partially
defatted butternut squash seed meal containing protein bound tryptophan in an amount from about 25-1000mg (claims 3). See also claims 1-2 and 4-6.
‘473 claims the human as suffering from insomnia (claim 7).
‘473 claims the composition as comprising a carbohydrate source having a high glycemic index selected from glucose, maltose, sucrose and combinations thereof (claims 8-9).
‘473 claims the composition further comprising vitamin B3, B6 and combinations thereof (claim 10).
‘473 claims the composition in the form of a tablet, powder, suspension, liquid, capsule or gel form (claim 11).
‘473 claims a dietary supplement (claim 12), wherein the supplement is formulated into a plurality of oral dosage forms for ingestion on a daily basis (claim 4).
‘473 claims the composition further comprising 5-50mg vitamin B3, 0.5-50mg vitamin B6 and combinations thereof (claim 13).
‘473 claims a composition comprising at least partially defatted butternut squash seed meal providing from about 25-50mg tryptophan, 75-100mg glucose and a vehicle (claim 14).
While ‘473 teaches a composition comprising partially defatted meal from a plant source naturally containing 25-1000 mg tryptophan, 25-200mg glucose, vitamin B3, B6 or combinations
thereof, and a carrier, it differs from that of the instantly claimed invention in that it does not teach an herb containing melatonin.
Padumanonda teaches melatonin content in traditional Thai herbal remedies used as sleeping aids (see title).
Melatonin is a neuroendocrine hormone produced primarily by the pineal gland in the brain from the amino acid tryptophan, stimulated by darkness and suppressed by light.
Melatonin is involved in circadian rhythm and regulation of diverse body functions, including sleep (pg. 1, 1st paragraph)
The melatonin content of the following herbs is taught:
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(pg. 3, Col. 2).
Jones ‘170 teaches a sleep promoting food formulation comprising melatonin, L-tryptophan, and an appropriate amount of high glycemic index carbohydrates (pg. 4, claim 1)
Jones further teaches such formulations as comprising about 0.3 mg to less than 10 mg melatonin ([0023]).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to add an herb containing melatonin, as taught by Padumanonda, to the composition of ‘473, to arrive at the instantly claimed invention.
One of ordinary skill in the art would have been motivated to make such an addition, with a reasonable expectation of success, because:
-‘473 is directed toward compositions for inducing sleep and Padumanonda teaches herbs containing melatonin as sleep aids; and
-Jones teaches compositions that combine ~0.3 to ~10 mg melatonin and tryptophan for promoting sleep ([0048]) and maintaining sleep for an appropriate period of time ([0033]).
As such, an ordinary skilled artisan would have been motivated to make such an addition, to predictably arrive at a composition that more effectively promotes sleeps. Furthermore, combining equivalents (sleep inducing/maintaining compounds) known for the same purpose (inducing/maintaining sleep), is prima facie obvious. MPEP 2144.06
Regarding the wherein clause in the last three lines of claim 1, it is noted that this clause is directed toward the intended use of the claimed composition and does not impart a structural difference to the composition. Since the combined composition of ‘473, Padumanonda, and Jones is capable of performing the intended use, this limitation is met. Moreover, since the combined composition of ‘473, Padumanonda, and Jones teaches the instantly claimed composition, the limitation “wherein, upon ingestion, the composition enhances sleep quality and duration and decreases sleep latency in mammals without suppressing endogenous melatonin synthesis in the mammal,” recited in instant claims 1, is met. See MPEP 2112.01.
Regarding instant claim 14, since ‘473 teaches the compositions in the form of a tablet, capsule, gel, or dietary supplement, this limitation “formulated in a plurality of oral dosages,” is met. It is noted that “for ingestion on a daily basis” is an intended use that is not afforded patentable weight since it is not a structural limitation and since the composition of ‘473 is capable of performing this limitation.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/L.Q.W./Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622