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, 3-8, 13 and 14) 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 administrating 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.” Applicant’s arguments have been fully considered; however, they are not found persuasive as indicated in the lack of unity/ restriction requirement that was mailed on February 24, 2026. The inventions lack unity of invention because the Tao reference disclose administering 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Claims 2 and 18-23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected inventions, there being no allowable generic or linking claim.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, 3-8, 13 and 14 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/EP2022/076159 is September 21, 2022, and FOR application number EP21198084.2 is September 21, 2021.
Information Disclosure Statement
The information disclosure statement (IDSs) submitted on March 20, 2024 and May 20, 2026 are being considered by the examiner. The signed IDS forms are attached with the instant office action.
Drawings
The drawings were received on March 20, 2024. These drawings are acceptable.
Claim Objections
Claims 3 and 4 objected to because of the following informalities: the term “wheren” should read “wherein”. Appropriate correction is required.
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, 3-8, 13 and 14 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 claim 1 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.
Regarding claim 3, the limitation "about 0.0 to about 45" and claim 4, the limitation “about 20.0 to about 45.0” renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). 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 14 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 5 and 7 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). The term “preferably” introduces ambiguity as to whether “balancing evening meal” is required limitation of the claim or merely optional or exemplary language. Furthermore, it is unclear as to what is meant by a “balanced” meal. The scope of a balanced meal is unclear. What amounts for what purpose is the meal to make it balanced?
Regarding claim 6, The term “better” is a relative term which renders the claim indefinite. The term “sleep quality” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. What criteria is better?
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 § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 3, 5-8, and 14 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 – 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; "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 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.
Claims 1, 3-5 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Ballevre et al.. (WO-2013078658-A1; Identified as Zhang on 892 form) in view of Oussama et. al. “Eucaloric Balanced Diet Improved Objective Sleep in Adolescents with Obesity” Nutrients 2021, 13, 3550. https://doi.org/10.3390/nu13103550.
Regarding claims 1, 3-4 and 14, which encompasses, the meal has glycemic load lower than that of the meal. Ballevre et al. ‘658 teaches, “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 [para. Last, and pg. 8 para 1-2). 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 95, GL is between 37.5 to 47.5). Although, Bellevre et al.. ‘658 does not teach the exact amount of glycemic load (GL) as recited in instant claims 3-4, 14, one of skilled in the art is aware that anything below a 55 is considered low GI. The teachings of the Ballevre et al. references are towards high GL, however one skilled in the art would be motivated to perform a method containing 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.
Regarding claim 5, Oussama et al.. teaches, “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 [para. 0001])” (as instant claims 5-6). The reference teaches the quality of sleep is dependent of balanced meal.
Ossama et. al. does not teach mulberry extract; however, the reference does teach the importance of balanced meal for better sleep. Additionally, Ballevre et. al.(i.e., improvement of sleep and mulberry leaf extract). 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 Ballevre et. al.(i.e., improvement of sleep and mulberry leaf extract), and incorporate the teachings of Ossama et. al. (i.e. importance of balanced meal for better sleep), one would achieve success for 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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/ALPA NILESH AMIN/Examiner, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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