DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant's election with traverse of Group I (claims 1, 3-9, 14 and 17) in the reply filed on April 22, 2026 is acknowledged. The traversal is on the ground that both independent claims 1 and 2 explicitly require "orally administering a composition to an individual at a predetermined time before consumption of a meal and/or concurrently with consumption of a meal, the combination of the composition and the meal has a glycemic load that is lower than that of the meal." Applicant’s arguments have been fully considered; however, they are not found persuasive as indicated in the lack of unity that was mailed on February 24, 2026. The inventions lack unity of invention because the Tao reference disclose a method for preparing the traditional Chinese medicine granules comprising a mulberry extract for improving sleep quality and therefore the technical feature linking the inventions of groups I and II does not constitute a special technical feature as defined by PCT Rule 13.2, as it does not define a contribution over the prior art.
The requirement is still deemed proper and is therefore made FINAL.
Claims 2 and 19-27 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on April 22, 2026.
Claims 1, 3-9, 14 and 17 are pending and under examination.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in the instant application, filed on March 20, 2024. The priority date of application number PCT/EP2022/076156 is September 21, 2022, and provisional application number 63/246,408 dated September 21, 2021.
Drawings
The drawings were received on March 20, 2024. These drawings are acceptable.
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.
Claims 1, 3-6, 8, 14 and 17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-8, 13, and 14 of copending Application No. 18/693,789 (reference application; US PGPUB 2024/0382549 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are of overlapping scope. The claims of the copending application are drawn to a method of improving sleep quality and/or subsequent behavioural outcomes, the method comprising orally administering a composition comprising a mulberry extract to an individual, at a predetermined time before consumption of a meal and/or concurrently with consumption of a meal. The meal combination of the composition and the meal has a glycemic load is lower than that of the meal and about 0.0 to about 45. The meal is an evening meal, preferably a balanced evening meal. The mulberry extract is preferably mulberry leaf extract. The composition further comprises an ingredient that lowers glycemic response, wherein the ingredient that lowers glycemic response is selected from the group consisting of multiple items, including tryptophan. The composition is administered to the individual once per day for at least three days (see claims 1, 3-8, 13, and 14).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 3-9, 14 and 17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 1 the phrase "predetermined time before consumption of a meal" renders the claim indefinite. The phrase "predetermined time before consumption of a meal" renders the scope of claim unclear. The term “predetermined time” is indefinite because the claim fails to specify any objective boundaries of the timing of objective boundaries of the timing of administration relative to meal consumption. It is unclear what duration constitutes “predetermined time” whether the time varies depending on the meal, the individual, or the desired outcome, and how one of ordinary skilled in the art would determine whether a given administration falls within the scope of the claim.
In claim 1, it is unclear what the behavioural outcomes are referring to. It is unclear what the scope of outcomes are claimed. In addition, what makes it “subsequent” in the alternative format with the conjugate “or”? In claim 1, it is unclear what sleep quality is referring to. The scope is unclear.
In claims 3, the limitation "about 0.0 to about 45" is unclear. There are no units or explanations provided for the amount. There is no manner in which to determine what this glycemic load is compared to. Is this calculated based of total amount of calories in meal or weight of the meal?
In claim 4, the limitation “about 11 to about 45” and “about 20.0 to about 45.0” renders the claim indefinite. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 4 recites the broad recitation about 11 to about 45, and the claim also recites about 20.0 to about 45.0 which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Furthermore, there are no units or explanations provided for the amount. There is no manner in which to determine what this glycemic load is compared to. Is this calculated based of total amount of calories in meal or weight of the meal?
The term “about” in claims 3, 4,and 7 is a relative term which renders the claim indefinite. The specification does not provide a standard for asserting the requisite degree, and one of ordinary skilled in the art would not be reasonably apprised of the scope of the invention.
Regarding claims 4 the phrase "preferably" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
All other claims depend directly or indirectly from the rejected claims and are, therefore, also rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, for the reasons set forth above.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 3-5, 14, and 17 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The claims are rejected for failing to describe the genus of any composition for administration. The claims do not recite a structural component that is encompassed by the composition being administered.
The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, at the time the invention was made, of the specific subject matter claimed. The courts have stated:
"To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997); In re Gostelli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) ("[T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed."). Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966." Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
Further, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. In Regents of the University of California v. Eli Lilly & Co. the court stated:
"A written description of an invention involving a chemical genus, like a description of a chemical species, 'requires a precise definition, such as by structure, formula, [or] chemical name,' of the claimed subject matter sufficient to distinguish it from other materials." Fiers, 984 F.2d at 1171, 25 USPQ2d 1601; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284985 (CCPA 1973) ("In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus ...") Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
MPEP § 2163 further states that if a biomolecule is described only by a functional characteristic, without any disclosed correlation between function and structure of the sequence, it is "not sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence." MPEP § 2163 does state that for a generic claim the genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. If the genus has a substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within that genus. See MPEP § 2163. Although the MPEP does not define what constitute a sufficient number of representative species, the courts have indicated what do not constitute a representative number of species to adequately describe a broad generic. In Gostelli, the courts determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gostelli, 872, F.2d at 1012, 10 USPQ2d at 1618.
As stated supra, the MPEP states that written description for a genus can be achieved by a representative number of species within a broad genus. Claim 1 is broadly generic to all possible compositions encompassed by the claims. The possible variations are enormous to any class. Since the MPEP states that if a biomolecule is described only by a functional characteristic, without any disclosed correlation between function and structure, it is "not sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence." MPEP § 2163. Here, though the claims may recite some functional characteristics, the claims lack written description because there is no disclosure of a correlation between function and structure beyond those disclosed in the examples in the specification. Moreover, the specification lacks sufficient variety of species to reflect this variance in the genus of any composition.
The description requirement of the patent statue requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736, F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does "little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate.") Accordingly, it is deemed that the specification fails to provide adequate written description for the genus of the claims and does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 3, 5, 6, 8, 14, and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Robert Fried and Richard Carlton (Type 2 Diabetes: Chapter 12, Functional Foods Continued – White Mulberry (Morus Alba) leaf extract and Tea).
Fried and Carlton teach oral administration, at a predetermined time before consumption of meal “The participants were given capsules containing 12 mg of DNJ-rich mulberry leaf extract, three times daily, before meals, for weeks (Functional Food book pg. 356 [para. 0001]). The mulberry leaf extract will necessarily result in the intended uses; Fired and Carlton also disclose the administration of DNJ (1-deoxynojirimycin; aka moranolin) to healthy volunteers (see page 350, section 12.5.1, 9th paragraph); "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986) (The claims were directed to a method of enhancing color effects produced by ambient light through a process of absorption and reflection of the light off a coated substrate. A prior art reference to Donley disclosed a glass substrate coated with silver and metal oxide 200-800 angstroms thick. While Donley disclosed using the coated substrate to produce architectural colors, the absorption and reflection mechanisms of the claimed process were not disclosed. However, King’s specification disclosed using a coated substrate of Donley’s structure for use in his process. The Federal Circuit upheld the Board’s finding that "Donley inherently performs the function disclosed in the method claims on appeal when that device is used in ‘normal and usual operation’" and found that a prima facie case of anticipation was made out. Id. at 138, 801 F.2d at 1326. It was up to applicant to prove that Donley’s structure would not perform the claimed method when placed in ambient light.). See also In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977) (Applicant claimed a process for preparing a hydrolytically-stable zeolitic aluminosilicate which included a step of "cooling the steam zeolite ... at a rate sufficiently rapid that the cooled zeolite exhibits an X-ray diffraction pattern ...." All the process limitations were expressly disclosed by a U.S. patent to Hansford except the cooling step. The court stated that any sample of Hansford’s zeolite would necessarily be cooled to facilitate subsequent handling. Therefore, rejections under 35 U.S.C. 102 and 103 were properly made. Applicant had failed to introduce any evidence comparing X-ray diffraction patterns showing a difference in cooling rate between the claimed process and that of Hansford or any data showing that the process of Hansford would result in a product with a different X-ray diffraction. Either type of evidence would have rebutted the rejections under 35 U.S.C. 102. A further analysis would be necessary to determine if the process was nonobvious under 35 U.S.C. 103.); Ex parte Novitski, 26 USPQ2d 1389 (Bd. Pat. App. & Inter. 1993) (The Board rejected a claim directed to a method for protecting a plant from plant pathogenic nematodes by inoculating the plant with a nematode inhibiting strain of P. cepacia. A U.S. patent to Dart disclosed inoculation using P. cepacia type Wisconsin 526 bacteria for protecting the plant from fungal disease. Dart was silent as to nematode inhibition but the Board concluded that nematode inhibition was an inherent property of the bacteria. The Board noted that applicant had stated in the specification that Wisconsin 526 possesses an 18% nematode inhibition rating.).
Claim(s) 1, 6, 7, and 9 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Ozeki et al. (US 2008/0044499 A1).
Ozeki et al. disclose a sleep improvement composition comprising: (a) theanine; and (b) at least one component selected from the group consisting of chamomile, lavender, Saint John's wort, kawakawa, valerian, passion flower, tryptophan, 5-HTP, serotonin, .gamma.-aminobutyric acid, melatonin, and cedrol (see claim 1). “Sleep improvement composition containing theanine, a food and a medical drug containing the same composition, a sleep improvement method using theanine (Field of the Art [para. 0001]); This invention's composition is not limited in particular in terms of administration method, number of times of administration, administration period, etc., and can be administered once or in a plurality of times by a suitable form of administration and preferably by oral administration to humans, preferably, humans desiring alleviation or improvement of sleep disorders (Best modes for carrying out the invention [para. 0026]).” Ozeki et al. disclose “sleep improvement method characterized in administering a composition comprising: (a) theanine; and (b) at least one component selected from the group consisting of tryptophan, gamma.-aminobutyric acid, melatonin, the use of (a) theanine and (b) at least one component selected from the group consisting of chamomile, lavender, Saint John's wort, kawakawa, valerian, passion flower, tryptophan, 5-HTP, serotonin, .gamma.-aminobutyric acid, melatonin, and cedrol for manufacturing a food or a medical drug to be applied to individuals with sleep disorder (Means for solving the problems [para. 0019-0020]).” Furthermore, “Tryptophan is a type of amino acid and is a source of serotonin, which is an endogenous sleep chemical, and melatonin, which is called a sleep hormone. The dosage of tryptophan at one time is 0.0005 mg/kg body weight to 10000 mg/kg body weight, preferably 0.01 mg/kg body weight to 1600 mg/kg body weight, and more preferably 1 mg/kg body weight to 100 mg/kg body weight (Best mode of carrying out the invention [para. 0038]).”
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 (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
Claim(s) 1, 3-9, 14 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Saidi et al. (Eucaloric balanced diet improved objective sleep in adolescents with obesity, Nutrients 2021, 14, 3550) and Zhang et al. (WO 2013/078658 A1).
Saidi et al. disclose adjusting dietary intake to energy requirement and reducing the energy proportion of the evening meal could have therapeutic effects on sleep in adolescents with obesity. Saidi et al. disclose “A more comprehensive understanding of how energy balance affects sleep in these populations would be of considerable interest in the development of future dietary strategies promoting better sleep and effective weight loss intervention. Therefore, in this study we sought to examine objectively measured sleep under two different conditions (1) controlled balanced diet adjusted to energy requirement (eucaloric), and (2) diet offered ad libitum among adolescents with obesity and their age-matched normal weight peers. In other words, we intended to examine if an adolescent with obesity in neutral energy balance and balanced macronutrient proportions would have better or worse sleep quality than a normal weight adolescent in positive energy balance and vice versa. We hypothesize that a eucaloric balanced diet would improve sleep quality in both groups” (Introduction, 3rd indented paragraph). The reference teaches the quality of sleep is dependent on a balanced meal. The reference discloses sleep improvement in obese group during an eucaloric balanced diet and reduced evening meal reduced sleep onset latency and less time in the light N1 sleep stage.
Zhang et al. disclose a composition comprising an extract of the berries of Morus spp.for use in the treatment or prevention of disorders linked to foods with a high glycemic index. The extract of the berries of Morus spp. may also be provided as natural compounds that can help to reduce glucose peaks in the blood of a subject after consumption of food with a high glycemic index (see abstract). Zhang et al. disclose “the composition of the present invention may be intended to be consumed immediately before, during and/or immediately after meal or beverage. Immediately before or after a meal shall be understood as the time frame ranging from about 30 minutes before a meal to about 30 minutes after a meal, preferably about 15 minutes before a meal to about 15 minutes after a meal (pg. 9 [para. 4-5; lines 10-16]).” Zhang et al. disclose the glycemic load “the composition may be a food composition with a high glycemic index to which an extract of the berries of Morus spp. was added. Consequently, the composition may further comprise a carbohydrate source. Food compositions with a GI of > 70 shall be understood as food composition with a high glycemic index (pg. 6-8). For example, food compositions with a high glycemic index may have a GI of above 75, above 80, above 85, above 90, or above 95. (For GI of 75 to 95, GL is between 37.5 to 47.5). One skilled in the art would be motivated to administer the mulberry extract with low GL meal composition and combination thereof, because it is known in the art high GL food content increases sugar in the body which leads to complications such as sleep as disclosed by Saidi et al.
Zhang et al. disclose, the extract of mulberry, “Any kind of berries from the Morus spp. May be used, for example, the Morus spp. May be selected from the group consisting of white mulberry (Morus alba L.), Black Mulberry (Morus nigra L.), American Mulberry, Red Mulberry (Morus rubra L.) … and combination thereof. The composition of the present invention may contain any amount of an extract of the berries of Morus spp. (page. 10 [para. 7-8; lines 20-29]).” Zhang et al. disclose, “Twenty-three healthy subjected participated in this study (Example 2: Dietary treatments-subjects [pg. 14, para. 0002, lines 7-10]).” And “results confirm the hypoglycemic activity of mulberry fruit juice concentrate in healthy volunteers (pg. 18-19, Table 5: Blood glucose levels).” The reference teaches that the experiment was performed in healthy (who do not have metabolic disorder) were given the test product of mulberry.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to utilize the teachings of Zhang et. al.(i.e. administration of mulberry leaf extract), with the teachings of Saidi et al. (i.e. sleep improvement in obese group during an eucaloric balanced diet and reduced evening meal reduced sleep onset latency), to achieve success for a method of improving sleep quality and subsequent behavioural outcomes, because having low GL and balanced meal would result in better sleep improvement.
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 effectively filled. As evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
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/ANAND U DESAI/ Supervisory Patent Examiner, Art Unit 1655
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