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 .
Priority
This application is a National-Stage entry of PCT/EP2023/054356, filed 2/22/2023. Applicant’s claim for the benefit of a US Provisional Application No. 63315752, filed 3/2/2022, under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 8/30/2024 and 4/10/2026 are acknowledged. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner, except where lined through and indicated below.
The information disclosure statement filed 4/10/2026 fails to fully comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. No English level translation for the non-patent publication “Chile Office Action for Appl. No. 202402545, dated February 12, 2026, 11 pages” has been provided. The document has been placed in the application file, but the information referred to therein has not been considered.
Various citations are referenced throughout the specification. The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Specification
The disclosure is objected to because of the following informalities:
The amendment to the specification filed on 3/12/2025 does not incorporate the preliminary amendment filed on 8/30/2024. It is presumed that the “CROSS REFERENCE TO RELATED APPLICATIONS” paragraph should have been included in the later-filed specification. Correction is required.
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code, on page 13. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Appropriate correction is required.
Claim Status
Applicant’s preliminary amendment to the claims filed 8/30/2024 is acknowledged. Claims 1-4 and 8-19 are pending and have been examined on the merits herein.
Claim Objections
Claims 4, 8, 10, and 16 are objected to because of the following informalities:
In claim 4 the abbreviation “T2D” is used. The meaning of this term is determined from the specification as “type-2 diabetes”. However, upon first recitation in the claims it is suggested to define the abbreviation so that the meaning is clear.
Similarly, in claim 8 the abbreviation NAFLD is used. This presumably means non-alcoholic fatty liver disease. The claim should be amended to recite: “non-alcoholic fatty liver disease (NAFLD)”.
In claim 10, a Markush group is recited, starting with the phrase “from the group consisting of”, however there is no recitation of “and” before the last element in the list. A Markush group should be a closed list of alternatives ending in “and”.
Claim 16 recites “from the group consisting of polyunsaturated fatty acids and/or monounsaturated fatty acids”. The claim is definite as it recites a Markush list that includes the following three options: polyunsaturated fatty acids, monounsaturated fatty acids, and combinations thereof. For clarity each option should be recited verbatim in the Markush list and “and/or” should be avoided for clarity. See MPEP § 2117.
Appropriate correction is required.
Claim Interpretation
Generally, terms and phrases in the claims have been interpreted under the Broadest Reasonable Interpretation (B.R.I.) in light of the specification. The specification has provided special definitions for several claim elements. All paragraph citations are in reference to the published application, US PGPUB No. 20250213635. Particular definition of note are:
“about,” “approximately” and “substantially” are used to refer to numbers in a range of numerals in a range of −10% to +10% around the specific value ([0042]);
“Overweight” is defined for a human as a body mass index (BMI) between 23 and 27.5 kg/m2 or between 25 and 30 kg/m2 ([0051]);
“standard mixed meal” refers to a meal which provides all of protein, carbohydrate, fat, vitamins and minerals, in quantities and proportions suitable to maintain health or growth of an individual, ([0081]);
“carbohydrate rich meal” refers to meal where 40 to 90% Kcal of the meal energy intake are coming from the carbohydrates, ([0082])
“medium to high GI mixed meal” refers to a meal having a GI above 55, preferably from 56 to 70 or more ([0084]).
It is noted that claims 1, 3, and 4 are each independent claims that recite essentially the same method comprising a step of: “orally administering to an individual in need thereof or at risk thereof a composition comprising at least one mulberry extract (ME), at least one source of fiber and at least one source of unsaturated fatty acids, with the meal”. The claims differ in the intended use and/or perhaps the intended subject to which the administering is performed. Regardless, they are being treated herein as different embodiments of the same method.
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.
Claims 4, 10, 13, and 17-18 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.
Claim 4 recites: “A method of improving glycemic control and/or T2D management; help manage weight loss; regulating appetite after a meal by increasing GLP-1” in lines 1-2. It is unclear from this preamble what the desired results or goal of the recited method is for claim 4. Are all three elements of 1): improving glycemic control and/or T2D management; 2) help manage weight loss; and 3) regulating appetite after a meal by increasing GLP-1 all required effects? Or was this meant to be a list of alternative effects? Because there is no “and” or “or” prior to the last element in the list, there is no manner for one to determine what is required of this preamble (e.g. a conjunction is required before “regulating appetite after a meal by increasing GLP-1”). For the purposes of examining, all of these elements have been treated as intended uses or desired results of which only one of the alternatives is required.
Claim 10 contains the trademark/trade name “Fibersol-2®”. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a specific formulation of “resistant starch” and, accordingly, the identification/description is indefinite. The specification at [0115] describes this product from Archer Daniels Midland Company as a digestion resistant maltodextrin. Further, there is no recitation in the claim of what this composition of starch is resistant to. It appears that the term was meant to refer to “digestion-resistant starch” ([0115]-[0116] of the specification).
Claim 13 recites that the meal is “a standard mixed meal and/or a carbohydrate-rich meal”. The claim is indefinite because one cannot adequately determine the metes and bounds of the claimed meals to select from. 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). Here the term “standard mixed meal” has been defined as a meal which provides all of protein, carbohydrate, fat, vitamins and minerals, in quantities and proportions suitable to maintain health or growth of an individual while a “carbohydrate rich meal” refers to meal where 40 to 90% Kcal of the meal energy intake are coming from the carbohydrates. Claim 13 as presented allows for a “standard mixed meal” or a “carbohydrate rich meal” but because it also recites “and/or” it also includes a combination of the two. These appear to be mutually exclusive selections because it is unclear how a mixed meal as defined herein could also be a carbohydrate rich meal. Because there is no clear meaning for the meaning of “and/or” as used herein, the resulting claim is indefinite. The claim should be amended to clearly delineate the two options (i.e. “a standard mixed meal or a carbohydrate-rich meal”).
Claim 17 and 18 both recite limitations regarding the amount of certain components. Claim 17 recites that there are unsaturated fatty acids “in an amount of at least 1g”. Claim 18 recites “the fiber is presented in the composition in an amount from about 1.5g to about 30g”. The claims are indefinite because there is no manner in which to determine the amount of the elements that are to be administered. The claims do not recite any proportion such as “per dosage” or “per 100 grams of the total composition”. Because there is no meaning to the recited amounts, the claims are indefinite. Further, no specific dose of the composition has previously been recited in the claims.
As merely an example, Claim 15 recites that a certain element is present in 100mg per serving, and language similar to this is recommended for claims 17 and 18 as well.
Claim Rejections - 35 USC § 103
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 1-4 and 8-19 are rejected under 35 U.S.C. 103 as being unpatentable over Dong et al. (WO-2021214292-A1) in view of Moosheer et al. ("A protein-enriched low glycemic index diet with omega-3 polyunsaturated fatty acid supplementation exerts beneficial effects on metabolic control in type 2 diabetes." Primary care diabetes 8.4 (2014): 308-314, on IDS filed 8/30/2024) and Buchar et al. (WO-2015009225-A1, on IDS filed 8/30/2024).
Dong et al. teaches a combined preparation of fibre (e.g. fiber) and a mulberry extract component along with methods of using this composition for controlling blood glucose response, enhancing weight loss and/or reducing fat mass gain (Abstract).
Dong discloses that the composition is useful in for preventing and/or treating hyperglycemia and/or the relevant conditions, such as prediabetes, diabetes and especially type-2 diabetes, impaired glucose tolerance, diabetic retinopathy, diabetic neuropathy, diabetic nephropathy, and/or for preventing or treating obesity (pg. 7, lines 20-24). Dong teaches that the composition helps control blood glucose levels, including both fasting glycaemia and postprandial glycaemia (pg. 3, lines 15-18). Dong teaches that the fiber and mulberry extract synergistically interact to control and regulate blood glucose levels, and that the mulberry component is preferably a mulberry leaf extract (MLE) (pg. 3, lines 20-30).
Dong states that the fiber is preferably a soluble fiber, selected from the group consisting of FOS, GOS, inulin, 13-glucan, resistant maltodextrins, acacia gum, partially hydrolyzed guar gum (PHGG), and polydextrose (pg. 3, lines 30-33).
Dong discloses in vivo examples wherein a composition comprising mulberry leaf extract having 1% DNJ and insoluble fiber, including inulin, was given at the same time as meals (Examples, pgs. 18-20). Dong teaches that for the experimental groups; mice were dosed at 200mg/kg/day of mulberry leaf extract (MLE) and at 5g/kg/day for the fiber.(pg. 19, lines 1-8).
Regarding claim 12, Dong teaches that “suitable compositions for the present invention may be in the form of powders, granules, tablets, chewables, soft gels, sachets, solutions (e.g. tonics), liquid suspensions, emulsions, or concentrate. The compositions of the present invention may be administered by any means suitable for human or animal administration, in particular for administration in any part of the gastrointestinal tract” (pg 16, lines 25-31).
Regarding claim 15, Dong teaches that the composition is administered in a serving that provides at least about 1mg of deoxynojirimycin (DNJ) and up to 100mg of DNJ (pg. 14, line 28 – pg. 15, line 10).
However, Dong does not expressly teach that the administration includes at least one source of unsaturated fatty acids, as required of the instant claims.
Moosheer et al. teaches the benefits of supplementation of omega-3 polyunsaturated fatty acids upon metabolic control and inflammatory responses in type-2 diabetes (Title, Abstract). Moosheer teaches that long chain n-3 PUFAs EPA and DHA, which can be found in fish oil, are well established to have anti-inflammatory effects are based on changed production of PUFA-derived lipid mediators (see e.g. pg. 312, right col). Moosheer discloses that patients received dosages of polyunsaturated fats, including 1.6g EPA and 0.8g DHA a day (pg. 309, right col, 2.2 Study design and intervention). Moosheer teaches that the addition of omega-3 PUFA led to improvements in various measures in the diet subjects tested therein, including a decrease in HbA1c levels (e.g. improved glycemic control) and decreases in waistline, et cetera (Abstract, Table 3, and Figure 1).
Buchar et al. (WO-2015009225-A1) discloses a food composition product for weight loss and diabetes management, comprising, along with a protein food source, omega-3 and omega-6 fatty acids and slowly digested carbohydrates including dietary fibers, which give said composition a low glycemic index (Abstract, pg. 3, lines 8-12). Buchar teaches that supplementing a diet with Omega-3 can attenuate weight gain and reduce body fat (pg 8, lines 14-28). Buchar also teaches that including functional fibers may significantly promote satiety and reduce cardiometabolic risk (pg. 9, lines 1-10).
Buchar also teaches that such dietary compositions can be provided in the form of a dry powder that is mixed with a drinkable liquid before serving, and that the composition can include dairy products (pg. 10).
Thus, before the filing date of the instant invention, it would have been prima facie obvious to one of ordinary skill in the art to administer with a meal a composition comprising a mulberry leaf extract and fiber (e.g. inulin), as taught in Dong et al., in combination with one or more polyunsaturated fatty acids (e.g. the omega-3 polyunsaturated fatty acids) according to the teachings of Moosheer and Buchar, for the expected benefit of reducing postprandial glucose and enhancing treatment of one or more metabolic conditions such as type-2 diabetes in a subject.
One would have been motivated to produce a composition having mulberry extract, fiber, and polyunsaturated fats such as omega-3 fatty acids (including EPA and DHA) because Moosheer teaches supplementing diets with omega-3 fatty acids to improve glycemic control in patients with type-2 diabetics, while the combined teachings of Moosheer and Buchar suggest that inclusion of omega-3 fatty acids can reduce weight and body fat. Dong et al. teaches a dietary supplement given during meals that comprises mulberry leaf extract and fiber, which are indicated to reduce postprandial glucose for the treatment of metabolic disorders including type-2 diabetes, and thus it would have been obvious to include additional beneficial compounds known to improve enhancing weight loss and/or reducing fat mass gain.
MPEP § 2143 - Rationale C describes that it is obvious to use a known technique to improve similar devices, methods, or products in the same way. Here, Dong teaches a base method and/or product, having all of the components of the instant invention except for the polyunsaturated fats. However, because Buchar teaches an analogous method wherein slowly digested carbohydrates including dietary fibers are provided with PUFAs (including omega-3 fatty acids) for the predictable benefit of in lessened inflammation and improved weight control, it would have been obvious to combine polyunsaturated fats with the similar composition taught in Dong, with the expected benefit of improved weight control and reductions in inflammation. This, coupled with the benefits on post-meal glucose conveyed by the Mulberry extract of Dong, would have led to a predictable and desirable enhancement for the treatment of metabolic disorders such as diabetes.
See also MPEP § 2144.06 which states that "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
Thus, the methods of claims 1-4 and 8-11 would have been obvious to one of ordinary skill in the art.
In regard to claim 12, Dong discloses that the edible preparation may be in any form known to the art, including in liquids or powders. One of ordinary skill in the art would have knowledge of suitable liquids to use for delivering the product, and the selection of milk would have been a matter of judicious selection among common food products in the art. Further, Buchar also suggests the use of a powder that is delivered in the form of a liquid, and teaches that the composition can include ingredients derived from dairy products. It is evident that the selection and providing of suitable liquids for ingesting the product is well-within the purview of one of ordinary skill in the art.
Regarding claims 13 and 14, the cited references establish that the supplementing of meals with the beneficial dietary supplements, including mulberry extract, fiber, and PUFAs leads to the reduction of the glycemic index of the meal along which it is administered. Because the described use of the supplements in the art includes reducing post-meal glucose to treat metabolic disorders, the meal with which the supplements are provided can essentially be any meal. To one of ordinary skill, it would have been obvious over the cited teachings, particularly those of Buchar and Dong, to provide glucose-lowering and weight-loss enhancing supplements with meals having high amounts of carbohydrates (i.e. high glycemic index meals).
Regarding claim 15, Dong explicitly teaches that the serving can comprise between 1mg to 100mg of DNJ per serving. As this is a known active component of mulberry extract, it would have been desirable to provide at effective concentrations, especially at the concentrations taught in the art.
Regarding claims 17-19, the claimed values for both the unsaturated fatty acids and the fiber appear to fall within or near to those that are taught in the art (however due to the 112(b) issues described above the actual requirement for the amount of these components per serving is unclear). Regardless, it is obvious and routine to optimize such concentrations. MPEP § 2144.05 describes that the determination of suitable or effective concentration/composition can be determined by one of ordinary skill in the art through the use of routine or manipulative experimentation to obtain optimal results, as these are variable parameters attainable within the art. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
From the teachings of the cited references, it is apparent that there would have been a reasonable expectation of success in combining the teachings therein to arrive at the claimed invention because all of the claimed components are known in the art for addressing treating hyperglycemia and metabolic dysfunction, while Dong teaches mulberry extracts with fiber and Buchar teaches adding unsaturated fats- including omega-3 fatty acids- to compositions including fiber, for ultimately the same purpose of reducing blood glucose.
Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date, as evidenced by the cited references, especially in the absence of evidence to the contrary.
Claims 1-4 and 8-19 are rejected under 35 U.S.C. 103 as being unpatentable over Orlowski et al. (US PGPub No. 20170028011) in view of Zhang (WO-2013078658-A1) and Buchar et al. (WO-2015009225-A1).
Orlowski et al. (US PGPub No. 20170028011) discloses dietary compositions comprising mulberry extract, coffee extract, bean extract, dietary fibers, and a nutraceutically acceptable carrier for preventing the increase in postprandial hyperglycemia and treating diseases and disorders associated therewith, including, inflammatory conditions, hyperlipidemia, insulin resistance, diabetes, visceral obesity, hypertension and cardiovascular diseases (Title, Abstract).
Orlowski teaches that the mulberry extract is an extract of white mulberry leaves ([0014]), and that the mulberry extract is rich in 1-deoxynojirimycin (DNJ) ([0088]).
Orlowski teaches that the dietary fiber is selected from the group consisting of glucomannan, inulin (Examiner notes that there appears to be an obvious misspelling in the original document, which states “insulin” instead of the fiber inulin), psyllium, oat gum, beta-glucan, guar gum, pectin, and soybean fiber, among others ([0015]).
Orlowski discloses compositions including inulin and white mulberry extract and teaches in vivo experiments demonstrating a reduction in blood glucose levels when administering a combination of dietary fibers and plant extracts including mulberry extract (Table 5, [0171]-[0175], and FIGs. 11 and 12).
Orlowski demonstrates that inclusion of the fiber inulin reduces blood glucose levels, whereas the combination of fiber with the plant extracts led to the greatest glucose reduction ([0175]). The supplements were provided with the food in these experiments (see [0172]).
Regarding claim 12, Orlowski teaches that the composition is provided in a form of powder suitable as a supplement to beverages and food products, such as milk, orange juice, mineral water, yogurt, pudding ([0102]; [0104]).
Regarding claims 13-14, Orlowski teaches providing the extracts and fiber compositions with various meals including carbohydrate-high bread meals (see examples 8-10, [0222]-[0258]). Orlowski also discloses that in some embodiments, the meal includes at least one food product having a high glycemic index ([0049]; [0219])
Regarding claim 18, Orlowski discloses using fiber including inulin (2000 mg) and glucomannan (3000 mg), which is more than 1.5 g (e.g. 2000mg is 2 g) ([0230]).
However, Orlowski does not explicitly teach that the Mulberry extract containing compositions is to be delivered simultaneously with a meal, nor does the reference expressly teach the inclusion of an unsaturated fat in the supplement.
Zhang et al. (WO-2013078658-A1) discloses 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 (Abstract). Zhang teaches that extract of the berries of mulberry may 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 (Abstract). Zhang teaches that it is known in the art that food products with more complex carbohydrates that take longer to digest may be used to increase the duration of satiety and to minimize the risk of developing obesity (pg. 1, lines 23-27). Zhang also teaches that Mulberry leaves have been used in Chinese Medicine to cure and prevent 'Xiao-ke' (diabetes) (pg. 4, lines 3-6).
Zhang specifically teaches that the disorders linked to foods with a high glycemic index that may be treated or prevented are selected from the group consisting of glucose intolerance abnormalities, impaired glucose tolerance, impaired fasting glucose, diabetes, overweightness, obesity, high blood pressure, high blood cholesterol, and heart disease (pg. 8, lines 11-17).
Zhang also teaches a method to reduce the glycemic index of a food product with a high glycemic index, comprising the step of adding an extract of Morus spp. to the food (pg. 10, lines 27 – pg. 11, line 2). To this regard, Zhang teaches that the composition may be consumed immediately before, during and/or immediately after a meal or beverage (pg. 9, lines 10-12), and discloses that the composition may be mixed with the meal or it may be consumed as an accompanying drink (pg. 9, lines 17-19).
Regarding claim 12, Zhang teaches that such “preparations provide naturally produced, cost-effective components that have a demonstrated hypoglycemic and long lasting energy effect in carbohydrate rich foods (e.g., porridge, pasta, cereal bars, cereal drinks, biscuits) and sucrose and/or maltose rich beverages and foods (e.g., ice cream)” (pg. 5, lines 16-21).
Regarding claim 15, Zhang discloses that the extract comprises at least 0.1 mg 1-deoxynojirimycin (DNJ) per g dry weight, preferably at least 1 mg DNJ per g dry weight (pg. 10, lines 15-17).
Buchar et al. (WO-2015009225-A1) discloses a food composition product for weight loss and diabetes management, comprising, together with a protein food source, omega-3 and omega-6 fatty acids and slowly digested carbohydrates including dietary fibers, which give said composition a low glycemic index (Abstract, pg. 3, lines 8-12).
Buchar teaches that supplementing a diet with the unsaturated omega-3 fatty acids attenuates weight gain and reduces body fat (pg 8, lines 14-28).
Buchar teaches that including functional fibers may significantly promote satiety and reduce cardiometabolic risk (pg. 9, lines 1-10).
Buchar also teaches that such dietary compositions can be provided in the form of a dry powder that is mixed with a drinkable liquid before serving, and that the composition can include dairy products (pg. 10).
Before the filing date of the instant invention, it would have thus been prima facie obvious to one of ordinary skill in the art to administer, with high-glycemic food, a composition comprising at least a mulberry leaf extract and dietary fiber, as taught in Orlowski, combined with one or more polyunsaturated fatty acids (e.g. the omega-3 polyunsaturated fatty acids) according to the teachings of Buchar, and to administer the composition having mulberry extract, fiber, and PUFAs during a meal as suggested by Zhang for the expected benefit of reducing postprandial glucose and enhancing treatment of one or more metabolic conditions such as diabetes in a subject.
One would have been motivated to produce a composition having mulberry extract, fiber, and polyunsaturated fats such as omega-3 fatty acids (including EPA and DHA) because Buchar teaches that inclusion of omega-3 fatty acids can reduce weight and body fat while Orlowski teaches a dietary supplement that comprises mulberry leaf extract and fiber, indicated to reduce postprandial glucose for the treatment of metabolic disorders including diabetes. It would have been obvious to include additional beneficial compounds such as polyunsaturated fats, which are known to improve enhancing weight loss and/or reducing fat mass gain.
MPEP § 2143 - Rationale C describes that it is obvious to use a known technique to improve similar devices, methods, or products in the same way. Here, Orlowski describes a base method and/or product, having all of the components of the instant invention except for the polyunsaturated fats. Buchar teaches an analogous method wherein slowly digested carbohydrates including dietary fibers are provided with PUFAs (including omega-3 fatty acids) for the predictable benefit of in lessened inflammation and improved weight control.
Thus, it would have been obvious to combine polyunsaturated fats with the similar composition taught in Orlowski for the predictable benefit of improved weight control and a reduced inflammation. The effects of the unsaturated fatty acids coupled with the benefits of lowering post-meal glucose and reduced glycemic index of the meal would have led to a predictable and desirable enhancement for the treatment of metabolic disorders such as diabetes.
See also MPEP § 2144.06 which states that "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
In regard to claim 12, Orlowski suggests that the composition is provided in a form of powder suitable as a supplement to beverages and food products, including as milk.
Regarding claims 13 and 14, the cited references establish that the supplementing of meals with the beneficial dietary supplements, including mulberry extract, fiber, and PUFAs leads to the reduction of the glycemic index of the meal in which it is administered with. Orlowski teaches providing mulberry extract containing supplements with carbohydrate heavy meals and with high glycemic-index meals.
Regarding claim 15, Zhang teaches that the extract preferably comprises at least 1 mg DNJ per gram of dry weight. Because this is a known active component of mulberry extract, it would have been desirable to provide at effective concentrations, especially at the concentrations established in the art.
Regarding claim 16, the omega-3 fatty acids taught in Buchar are polyunsaturated fats.
Regarding claims 17-19, the claimed values for both the unsaturated fatty acids and the fiber appear to fall within or near to those that are taught in the art (however due to the 112(b) issues described above the actual requirement for the amount of these components per serving is unclear). Regardless, it is obvious and routine to optimize such concentrations. MPEP § 2144.05 describes that the determination of suitable or effective concentration/composition can be determined by one of ordinary skill in the art through the use of routine or manipulative experimentation to obtain optimal results, as these are variable parameters attainable within the art. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
For claims 18 and 19, Orlowski teaches compositions with more than 2g of dietary fiber, wherein the fiber includes inulin (note that there is a misspelling of inulin for “insulin” in the specific cited section, however it is understood to be inulin because insulin is a hormone, not fiber).
From the teachings of the cited references, it is apparent that there would have been a reasonable expectation of success in combining the teachings therein to arrive at the claimed invention because all of the claimed components are known in the art for addressing treating hyperglycemia and metabolic dysfunction; Orlowski teaches compositions having mulberry extracts and fiber and Buchar teaches adding unsaturated fats- including omega-3 fatty acids- to compositions including fiber, for ultimately the same purpose of reducing blood glucose and treating metabolic disorders.
Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date, as evidenced by the cited references, especially in the absence of evidence to the contrary.
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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Claims 1-4 and 8-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 12,539,322 in view of Buchar et al. (WO-2015009225-A1, of record).
Claims 1 and 3 of the reference patent (the ‘322 patent) pertain to:
a method of reducing postprandial glucose from a balanced meal, the method comprising: orally administering to an individual a composition comprising a mulberry extract (ME) with the balanced meal, wherein the mulberry extract has a concentration of 1-deoxynojirimycin (DNJ) of at least 5% wt/wt (claim 1); and
a method of treating at least one condition for which reduced postprandial glucose and/or postprandial insulin from a meal is beneficial, the method comprising: orally administering to an individual in need thereof or at risk thereof a composition comprising a mulberry extract (ME) with a balanced meal, wherein the mulberry extract has a concentration of 1-deoxynojirimycin (DNJ) of at least 5% wt/wt; and wherein the at least one condition is selected from the group consisting of overweight, obesity, pre-diabetes, gestational diabetes mellitus, and diabetes (claim 3).
Thus, it is clear that the reference claims are drawn to methods of reducing postprandial glucose and of treating at least one condition for which reduced postprandial glucose and/or postprandial insulin from a meal is beneficial, same as the instant claims.
Claim 6 of the reference claim recites that the mulberry extract is provided with at least one additional component selected from the group consisting of a fibre, a vitamin, a mineral, and any combination thereof.
Claim 4 of the ‘322 patent recites that the mulberry extract is in the form of a powder or granulate, and is mixed into or added onto the balanced meal.
Claim 5 of the ‘322 patent recites that the composition is administered to the individual in a serving comprising about 1 mg up to about 100 mg of 1-deoxynojirimycin (DNJ) per serving, as recited in the instant claim 15.
Claim 7 of the ‘322 patent recites that the mulberry extract is a mulberry leaf extract, as recited in the instant claim 9.
Claims 9 and 10 of the ‘322 patent recite that the balanced meal provides 45-65% of total calories from carbohydrate, 20-35% of total calories from fat, and 10-35% of total calories from protein.
Regarding the selection of the fiber, as in claims 10-11 and 19, the claims do not explicitly discuss the identity of the fiber, however the specification of the ‘322 patent states that “Non-limiting examples of suitable soluble fibres include FOS, GOS, inulin, resistant maltodextrins, partially hydrolysed guar gum, polydextrose and combinations thereof.” (Col 10, lines 25-41). MPEP §804.II.B.1. establishes that "The Patent and Trademark Office (‘PTO’) determines the scope of the claims in patent applications not solely on the basis of the claim language, but upon giving claims their broadest reasonable construction ‘in light of the specification as it would be interpreted by one of ordinary skill in the art.’ " Phillips v. AWH Corp., 415 F.3d 1303, 1316, 75 USPQ2d 1321, 1329 (Fed. Cir. 2005) (en banc) (quoting In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1364, 70 USPQ2d 1827, 1830 (Fed. Cir. 2004);” and also describes that “the portion of the specification of the reference that describes subject matter that falls within the scope of a reference claim may be relied upon to properly construe the scope of that claim. In particular, when ascertaining the scope of the reference’s claim(s) to a compound, the examiner should consider the reference’s specification, including all of the compound’s uses that are disclosed. See Sun Pharm. Indus., 611 F.3d at 1386-88, 95 USPQ2d at 1801-02.”
However, the claims of the reference patent do not disclose subject matter wherein the composition includes one or more unsaturated fats, as required in each of the instant claims.
Buchar et al. (WO-2015009225-A1, discussed above) discloses a food composition product for weight loss and diabetes management, comprising a protein food source, omega-3 and omega-6 fatty acids along with slowly digested carbohydrates (e.g. dietary fibers), which give said composition a low glycemic index (Abstract, pg. 3, lines 8-12).
Buchar teaches that supplementing a diet with unsaturated omega-3 fatty acids attenuates weight gain and reduces body fat (pg 8, lines 14-28). Buchar teaches that including functional fibers may significantly promote satiety and reduce cardiometabolic risk (pg. 9, lines 1-10).
Buchar also teaches that such dietary compositions can be provided in the form of a dry powder that is mixed with a drinkable liquid before serving, and that the composition can include dairy products (pg. 10).
Thus, the method of the instant claims would have been at least obvious over the subject matter of the ‘322 patent claims, when considered in view of the teachings of Buchar in view of the ordinary level of skill and knowledge in the art.
Buchar teaches adding unsaturated fats- including omega-3 fatty acids- to food supplement compositions which include fiber, for ultimately the same purpose of reducing blood glucose and treating metabolic disorders as that of the ‘322 claims, and thus one of ordinary skill would have recognized that combining the mulberry extract and fiber with one or more polyunsaturated fatty acids would result in the predictable benefits of improved weight control and a reduced inflammation. The ‘322 patent pertains to administering such a composition for lowering post-meal glucose and treating metabolic disorders diabetes, and thus the administration of a composition having mulberry extract, fiber, and polyunsaturated fats would result in a predictable enhancement for the treatment of metabolic disorders including diabetes.
Further, the omega-3 fatty acids are taught to lower inflammation.
Thus, the combination and administration of several compounds for essentially the same purpose (herein reducing post-meal glucose) would have been obvious to one of ordinary skill with a reasonable expectation of success because each of the components are known to the art for treating metabolic disorders.
The dependent claims of the instant invention recite additional obvious limitations, in view of the cited claims of the ‘322 and Buchar et al..
Claims 10 and 11 would have been obvious in view of the ‘322 patent claims and Buchar because inulin is one of the exemplary embodiments of the species of the dietary fiber. MPEP §804.II.B.1. states that “If the reference patent discloses several species within the scope of the reference genus claim, that portion of the disclosure should be analyzed to properly construe the reference patent claim and determine whether it anticipates or renders obvious the claim in the application being examined”.
It would have been obvious to provide the claimed composition as a milk-based formula because the ‘322 patent claims include providing the composition as a powder or granulate mixed into or added onto the balanced meal. Further, Buchar also suggests the use of a powder that is delivered in the form of a liquid, and teaches that the composition can include ingredients derived from dairy products. One of ordinary skill in the art would have knowledge of suitable liquids to use for delivering the product, and the selection of milk would have been a matter of judicious selection among common food products in the art. It is evident that the selection and providing of suitable liquids for ingesting the product is well-within the purview of one of ordinary skill in the art.
Regarding claims 12 and 13, the ‘322 patent claims explicitly disclose that the meal is a balanced meal. It is noted that based on the instant specification, the terms “standard mixed meal” refers to a meal which provides all of protein, carbohydrate, fat, vitamins and minerals, in quantities and proportions suitable to maintain health or growth of an individual and a “medium to high GI mixed meal” refers to a meal having a GI above 55, preferably from 56 to 70 or more. The balanced meal of the ‘322 patent appears to be essentially the same as the standard mixed meal and the medium GI mixed meal of the instant claims (see e.g. Example 1, Col 12, line 45 – Col 13, line 32 of the ‘322 specification as an embodiment describing the balanced meal). There is no evidence that the selection of the meal for which the composition is administered is critical to any unexpected results. Further, because the described use of the supplements in the art includes reducing post-meal glucose to treat metabolic disorders, the meal with which the supplements are provided can essentially be any meal that could raise blood glucose.
Regarding claims 17-19, the claimed values for both the unsaturated fatty acids and the fiber appear to fall within or near to those that are taught in the art (however due to the 112(b) issues described above the actual requirement for the amount of these components per serving is unclear). Regardless, it is obvious and routine to optimize such concentrations. MPEP § 2144.05 describes that the determination of suitable or effective concentration/composition can be determined by one of ordinary skill in the art through the use of routine or manipulative experimentation to obtain optimal results, as these are variable parameters attainable within the art. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Thus, in the absence of evidence to the contrary, the selection and providing of the unsaturated fatty acid and the fiber component, including wherein the fiber is inulin, in a specific concentration is a matter of routine optimization.
For the reasons described above, the instant claims are considered to be obvious over the claims of the ‘322 patent and the teachings of Buchar.
Citation of Pertinent Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Li et al. ("Mulberry leaf polyphenols and fiber induce synergistic antiobesity and display a modulation effect on gut microbiota and metabolites." Nutrients 11.5 (2019): 1017) pertains to studies on the administration of mulberry leaf powder (MLP), mulberry leaf fiber (MLF), mulberry leaf polyphenols (MLPS), mulberry leaf fiber and polyphenols mixture (MLM) for the treatment of obesity (Abstract). Li demonstrates that the composition having mulberry leaf fiber and polyphenols mixture (MLM) had the best efficiency on weight loss (Abstract, Table 3).
Chung et al. ("Acute intake of mulberry leaf aqueous extract affects postprandial glucose response after maltose loading: Randomized double-blind placebo-controlled pilot study." Journal of Functional Foods 5.3 (2013): 1502-1506.) discusses the effect of mulberry leaf aqueous extract (MLAE) on postprandial glucose responses and teaches that ingestion of MLAE led to a decrease in post-challenge acute glucose levels (Abstract, Title).
Conclusion
No claims are allowabled.
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/A.T.M./Examiner, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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