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 .
DETAILED ACTION
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02/05/2026 has been entered.
The Amendment filed on 02/05/2026, amended claim 1.
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Claim 20 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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REJECTIONS WITHDRAWN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 amendment to claim 1 is sufficient to overcome this objection.
REJECTIONS-MAINTAINED & MODIFIED
The below prior art and double patenting rejections have been slightly modified.
Claim Rejections - 35 USC § 112(b)
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.
(New) Claim 9 is 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.
Claim 9 recites polished and aromatic rice grains in a Markush group of “pigmented rice grains.” However, neither polished nor aromatic rice grains are a type of pigmented rice. It is not clear if this is a typo and Applicant intended to recite a type of polished and aromatic pigmented rice, or if Applicant is claiming polished and aromatic rice grains, in general, as pigmented rice grains, which is contrary to what is known in the art.
Where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). The terms “polished. . .aromatic. . .rice grains” in claim 9 is used by the claim to mean “pigmented rice grains,” while the accepted meaning of polished rice is white rice that has its outer bran layer and germ remove, and the accepted meaning of aromatic rice is either white or pigmented rice characterized by a nutty aroma and taste.” The terms are indefinite because the specification does not clearly redefine the term.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
(Slightly Modified) Claims 1-2, 6, 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).
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, and a physiologically-acceptable diluent or 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 teaches a sleep promoting food formulation comprising melatonin, L-tryptophan, and an appropriate amount of high glycemic index carbohydrates (pg. 4, claim 1), wherein the melatonin and tryptophan are provided by plant sources. 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, from plant sources, 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 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 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).
(Slightly Modified) Claim 8 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) 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), and 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, Padumanonda, and Jones are applied as discussed above and incorporated herein.
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, and a physiologically acceptable diluent or carrier, 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).
Jones teaches the L-tryptophan as provided in a food such as rice, and teaches the L-tryptophan as proteins rich in tryptophan and peptide rich in tryptophan (pg. 4, claim 6; [0036]).
Comai teaches free and protein-bound tryptophan is found in rice, and specifically teaches Oryza sativa as the species of rice (abstract, Table 1, pg. 1352; Table 2, pg. 1353).
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 rice, a cereal, as another 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 addition, 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 make such an addition, to predictably arrive at a composition comprising protein-bound tryptophan derived from different plant sources, to increase the concentration of tryptophan for the promotion of sleep.
Alternatively, 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 substitute the seed plant source of Hudson, with rice, a cereal plant source, 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 for use in such compositions,
-Jones the L-tryptophan as proteins rich in tryptophan and peptide rich in tryptophan, and
-Hudson teaches the tryptophan as derived from a plant source,
As such, an ordinary skilled artisan would have been motivated to make such a substitution, to predictably arrive at a composition comprising protein-bound tryptophan derived from rice, to provide tryptophan for the promotion of sleep.
Furthermore, substituting equivalents (plant sources comprising protein-bound tryptophan) known for the same purpose (comprising protein-bound tryptophan for sleeping promoting formulations) is prima facie obvious, see MPEP 2144.06.
(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), and 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 claim 8 above and further in view of Kushwaha (Black Rice, Research, History, and Development, published 2016, 2016, PTO-892) and 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, Jones, and Comai, teaches a composition comprising 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, and a physiologically acceptable diluent or carrier, it differs from that of the instantly claimed invention in that it does not teach the species of rice recited in instant claim 9.
Comai teaches rice comprising protein bound tryptophan as Oryza sativa, and Kushwaha teaches Oryza sativa varieties as black rice (pg. 1-3)
Thanuja teaches black rice as a functional food with health benefits (abstract), wherein 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 as the rice in the combination of Hudson, Padumanonda, Jones, and Comai, 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, Jones, and Comai teaches protein bound tryptophan as derived from rice,
-Comai teaches Oryza sativa as rice containing protein-bound tryptophan,
-Kushwaha teaches Oryza sativa as a type of black 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 the Oryza sativa black rice as the rice in the combination of Hudson, Padumanonda, Jones, and Comai, to predictably arrive at a rice source containing protein-bound tryptophan that is effective to promote sleep.
Response to Declaration
The Declaration under 37 CFR 1.132 filed 02/05/2026 is insufficient to overcome the rejection of claims 1-2, 6, 8-9, and 12-18 based upon 35 USC 103 as set forth in the last Office action.
Prior to responding to the individual arguments in the declaration, it is respectfully pointed out that the Declaration provides no data or evidence, but states the inventor’s informed opinion as one of skill in the art. As discussed in MPEP 716.01(c), “Although an affidavit or
Declaration which states only conclusions may have some probative value, such an affidavit or declaration may have little weight when considered in light of all the evidence of record in the application.”
In paragraph 5, Declarant argues “Given my experience, I predict. . .based on the research available, the addition of melatonin would suppress the critical synthesis enzyme of melatonin through a negative feedback loop on the rate-limiting enzyme arylalkylamine N-acetyltransferase. That expectation was a reason that my original invention disclosed in Hudson WO 01/89319 did not include melatonin.”
This argument has been fully considered, but is not found persuasive. Regarding WO 01/89319, since this publication does not discuss melatonin, there is no means of definitely evaluating the statement “That expectation was a reason that my original invention disclosed in Hudson WO 01/89319 did not include melatonin.” Regarding the melatonin negative feedback loop, Declarant has provided no evidence to substantiate this claim. Moreover, melatonin and products containing melatonin are well known in the art to have a positive effect on sleep and useful in promoting sleep, as evidenced by the teachings of the prior art, above and the instant specification. As such, it appears that Declarant is stating that all sleep products comprising melatonin would be expected to suppress endogenous melatonin and be ineffective in promoting sleep. Further, even if this statement was substantiated with evidence, it is not clear how this would result in an unexpected result, since melatonin administered to a patient would make up for a deficit in endogenous melatonin, and it takes time for this negative feedback loop to suppress the synthesis of melatonin, possibly resulting in an effect that is after the average patient that is administered the melatonin, has fallen asleep.
Moreover, the prior art, such as Jones teaches a sleep promoting food formulation comprising melatonin and L-tryptophan, (pg. 4, claim 1), wherein the melatonin and tryptophan are provided by plant sources.
In paragraph 6, Declarant states that in beta testing of the new formulation comprising melatonin, improved sleep response was observed and that this is a new and unexpected result.
This argument has been fully considered, but is not found persuasive. It is respectfully pointed out that Applicant has provided no comparative data with the closest prior art, i.e., Hudson and/or Jones, and melatonin, alone, to substantiate this statement.
In paragraph 8, Declarant states that Comai concludes that protein-bound tryptophan cannot cross the blood-brain barrier, which directly contradicts the teachings of the present invention, and thereby should not be relied upon in combination with the other references cited. In paragraph 9, Declarant states that “Comai teaches away from my invention and combining Comai with Hudson WO 01/89319 does not result in my invention, which facilitates the entry of protein-bound tryptophan into the brain.”
These arguments have been fully considered, but is not found persuasive. It is respectfully pointed out that Comai is relied upon to teach that rice contains protein-bound tryptophan, and 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” in instant claim 8. Regarding the blood-brain barrier and tryptophan, the instant specification teaches, 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.” And instant claims 1 and 8 recite “vitamin B3, B6, and combinations thereof in an amount sufficient to enhance uptake of the 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,” i.e., rice, in composition with glucose and vitamin B3, B6, and combinations thereof, and since Hudson and the instant specification teaches that it is the glucose and the vitamins B3, B6, and combinations thereof, that transport the tryptophan across the blood-brainer barrier, the combined composition of Hudson, Padumanonda, Jones, and Comai, does not teach away from the instantly claimed composition.
In paragraph 10, Declarant argues that Jones teaches away from the instant invention since it calls for the use of L-tryptophan, which is the free amine form of tryptophane and that the instant applicant does not claim L-tryptophan or any synthetic variant but a natural, amide-bound tryptophane, which is both chemically and functionally distinct.
This argument has been fully considered, but is not found persuasive. It is respectfully pointed out that the L-tryptophan of Jones is not a synthetic variant, but a natural tryptophan, and it is respectfully pointed out that Jones teaches the L-tryptophan as provided in a food such as rice or other plant sources, and teaches its L-tryptophan as proteins rich in tryptophan and peptide rich in tryptophan (pg. 4, claim 6; [0036]). Additionally, Comai teaches rice as comprising both free and protein-bound tryptophan. As such, Jones does not teach away from the instantly claimed invention.
In paragraph 11, Declarant states that protein bound tryptophan competes with other LNAAs for transport across the blood-brain barrier, leading to a paradox wherein blood tryptophan rises, but brain levels fall, and Applicant references his own publication, i.e., Hudson WO 01/89319, and Jones as evidence of this paradox. In paragraph 12, Declarant states that his invention uniquely address this by including partially defatted seed meal to increase tryptophan concentration, adding a high glycemic index carbohydrate, selectively shunting competing LNAAs to the liver, and incorporating Vitamins B3 and B6, necessary co-factors in serotonin and melatonin synthesis, and that none of the references cited disclose this invention.
This argument has been fully considered, but is not found persuasive. It is respectfully pointed out that this argument is outside the scope of independent claim 8, which recites “a cereal plan source containing protein-bound tryptophan” and not “a plant source containing protein-bound tryptophan having at least partially defatted seed meal in an amount of 25 mg to 100mg of tryptophan.” It is next respectfully pointed out that WO01/89319 to Hudson specifically address tryptophan and the blood-brain barrier in reference to a high glycemic index carbohydrate and vitamin B3, B6, and combinations thereof:
-“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” (abstract);
-“the invention provides an efficacious and beneficial supply of tryptophan across the blood brain barrier by providing a supply of protein-bound tryptophan from a suitable plant source in an edible, digestible form to generate tryptophan in vivo” (pg. 2, lines 12-14);
-“The composition further, preferably, comprises a carbohydrate source, such as glucose, in an amount sufficient to enhance uptake of tryptophan across the blood brain barrier and to circumvent the competition for BBB transport sites into the central nervous system” (pg. 2, lines 23-27)
-“Without being bound by theory, it is believed that the carbohydrate source facilitates the uptake of tryptophan per se across the blood brain barrier, where it is made available for metabolism into serotonin” (pg. 5, lines 4-9);
-“the composition. . .comprises at least partially defatted squash seeds. . .glucose in an amount sufficient to facilitate uptake of the tryptophan provided from the squash seeds across the blood brain barrier in the individual consuming the composition” (pg. 6, lines 17-23);
-“the tryptophan is provided in a form that is capable of crossing the blood brain barrier” (claim 22).
As such, WO 01/89319, a prior art reference with the same inventor as the instant invention, already teaches the transport of protein-bound tryptophan across the blood-brain barrier, in a composition comprising glucose and vitamins B3, B6, and combinations thereof.
In paragraph 13, in reference to Jones, Declarant argues that the invention is distinct from Jones in that Jones uses rice as a source of L-tryptophan and melatonin and that rice only contains about 0.03% tryptophan, which is far below therapeutic thresholds and that rice includes high levels other LNAAs that worsen the TRP/LNAA ratio.
This argument has been fully considered, but is not found persuasive. It is first respectfully pointed out that Declarant has provided no evidence to substantiate these statements. Moreover, in reference to claims 1-2, 6, and 12-18, the rejection merely relies on Jones to teach that it is known in the art to combined tryptophan from plant sources, melatonin from plant sources, and high glycemic index carbohydrates, into formulations for the promotion of sleep. Regarding claims 8-9, the rejection provides two obviousness rationales, one wherein the rice source tryptophan is added to the composition of the combination of Hudson and Padumanonda, and another wherein the rice source tryptophan is substituted for the seeds in the combination of Hudson and Padumanonda. Since Jones teaches “A sleep promoting food formulation comprising an appropriate amount of melatonin, an appropriate amount of L-tryptophan and an appropriate amount of high glycemic index carbohydrates,” (claim 1) and further teaches the L-tryptophan as provided in the form of rice and as protein and peptide rich in tryptophan, Jones does teach tryptophan in a therapeutically effective amount, i.e., an amount to promote sleep in combination with melatonin and high glycemic index carbohydrate.
In paragraph 14, Declarant states that Padumanonda only identifies trace amounts of melatonin in herbs and that such trace amounts would require consumption of kilograms of herbal material to reach the effective dosage of the invention.
This argument has been fully considered, but is not found persuasive. Declarant has provided no evidence to substantiate this statement. It is further respectfully pointed out that both independent claims 1 and 8 recite “an herb containing melatonin,” and that neither claim 1 nor claim 8 recite an amount of melatonin. Moreover, Padumanonda teaches melatonin in herbs, in amounts useful to be used as sleeping aids. Lastly, it is pointed out that instant claim 17, teaches amounts as low as 3 micrograms of melatonin for use in its compositions.
In paragraph 15, Declarant states that the instant invention utilizes low dose (0.2mg) melatonin rather than relying in higher dosage (1mg) of exogenous melatonin, and that the low dosage stimulates rather than suppresses the rate limiting enzymes, and that 1mg 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. It is first respectfully pointed out that Applicant has provided no evidence to substantiate the claim that a specific dosage of melatonin has a specific effect. It is additionally pointed out that the instant, independent claims do not recite any amount of melatonin, let alone a low-dose, 0.2mg amount. And instant claim 17 teaches an amount of melatonin range from 3µg to 12mg. Further, Jones is relied upon to teach that it is known in the art to combine tryptophan, melatonin, and high glycemic index carbohydrate in a formulation for promoting sleep, and Jones teaches its formulations as comprising about 0.3mg to less than about 10mg ([0023]).
In paragraph 16, Declarant argues that the invention “promotes all-night endogenous melatonin production from tryptophan, avoiding suppression pathways.”
This argument has been fully considered, but not found persuasive since Applicant has provided no data or evidence to support unexpected results. Regarding unexpected results, 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).
In view of the foregoing, when all of the evidence is considered, the totality of the rebuttal evidence of nonobviousness fails to outweigh the evidence of obviousness.
Response to Arguments
Applicant’s arguments on pgs. 5-8, Remarks, mirror those in the Declaration. These arguments are fully addressed above.
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.
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(Slightly 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.
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]).
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).
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 tryptophan from a plant source, melatonin from a plant source, and high glycemic index carbohydrate, as promoting sleep, 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.
(Slightly 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.
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]).
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).
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 comprising tryptophan from plant sources, melatonin from plant sources and high glycemic index carbohydrates, for the promotion of sleep.
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.
Response to Arguments
Applicant’s arguments on pg. 8, Remarks, mirror those in the Declaration regarding effects on AANAT and long-term endogenous melatonin regulation. These arguments are fully addressed above.
Regarding ‘543 and ‘473 not incorporating an herb containing melatonin, it is respectfully pointed out that these rejections are obviousness-type Double Patenting rejections, wherein Padumanonda and Jones are relied upon to arrive at the instantly claimed composition comprising melatonin.
Conclusion
No claims are allowed.
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/LAUREN WELLS/Examiner, Art Unit 1622
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