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 .
Claims 1-3, 5-6, 8-9, 11-13, 15-16, and 18-24 are pending in the application. Claims 1-3, 5-6, 8-9, 11-13, 15-16, and 18-24 will be examined.
Priority
This application claims benefit to U.S. Provisional Application No. 63/618,255 filed January 5, 2024.
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 13 and 16 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 13 recites “17 µg to about 600 µg of elemental chromium per serving”. Because there is no article prior to “elemental chromium”, it is unclear if this is a different “elemental chromium” that the one claimed in independent claim 1 from which claim 13 depends. Applicant should clarify the claim. For compact prosecution, claim 13 is being interpreted as “the elemental chromium”.
Claim 16 recites “the dietary composition comprises about 40 mg to about 200 mg of a cinnamon extract per serving”. Because of the use of the article “a” prior to “cinnamon extract”, it is unclear if this is a different “cinnamon extract” than the cinnamon extract claimed in independent claim 1 from which claim 16 depends. Applicant should clarify the claim. For compact prosecution, claim 16 is being interpreted as “the cinnamon extract”.
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.
Claim Rejections - 35 USC § 102
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.
Claims 1, 8, 11, 15, 21, 22, 23, and 24 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Ivie (US 2015/0079199).
Regarding claims 1, 8, 11, and 15, Ivie discloses a dietary supplement composition is produced to have the ingredients shown in Table 2.
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342
406
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(page 8, Example 2, Table 2)
Ivie further discloses a dietary supplement composition is produced to have the ingredients shown in Table 3.
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352
400
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(page 8, Example 3, Table 3)
The compositions in Table 2 and 3 comprise: Mulberry extract (mulberry extract); whey protein concentrate, whey protein isolate, and calcium caseinate (diary proteins); inulin (fiber); chromium oligofructose complex (chromium); and cinnamon bark extract (cinnamon extract).
Ivie discloses scored questionnaires, consisting of a psychometric response scale, were used to measure subjective data on Day 0 (baseline). All participants completed subsequent scored questionnaires on days 28, 42, and 56 to assess subjective levels of energy and satiety. The participants were given dietary supplement compositions similar to those provided in Examples 2 and 3 and told to take the product twice a day (page 8, paragraph 70).
Regarding claims 21, 22, 23, and 24, directed to stabilizes blood glucose concentration in a mammal; slows the rate of glucose absorption in a mammal; increases satiety in a mammal; and decreases hunger cravings in a mammal, respectively, Ivie discloses compositions comprising mulberry extract, diary proteins, fiber, chromium, and cinnamon extract in Tables 2 and 3, therefore, the properties possessed by the composition of the instant application, stabilizes blood glucose concentration, slows the rate of glucose absorption, and increases satiety, would be possessed by the prior art. Where the claimed and prior art product(s) are identical or substantially identical, the burden of proof is on applicant to establish that the prior art product(s) do not necessarily or inherently possess the characteristics of the instantly claimed product(s), see In re Best, 195 USPQ 430.
In addition, regarding claim 21, Ivie discloses there was a statistically significant reduction (p=0.00005) in serum glucose levels. There was a statistically significant reduction (p=0.0067) in insulin levels (page 8, paragraph 72).
In addition, regarding claim 22, Ivie discloses FIG. 1 depicts the fasting glucose levels for the test subjects consuming the tested dietary supplement compositions over the course of the study (56 days). As shown, the test subjects reported an 8% decrease in fasting glucose levels over the course of the study (page 9, paragraph 73).
In addition, regarding claim 24, Ivie discloses that in order to measure energy levels and satiety, each test subject was asked to rate his/her intensity of energy, intensity of fatigue, current degree of hunger, and current assessment of how much they could eat along a 100 mm horizontal line. The subjects completed the questionnaire by placing a vertical slash on the line corresponding to their sensation for each question. FIG. 2 shows how the fatigue intensity changed over the course of the study. As shown, test subjects using the tested dietary supplement compositions reported a 54% decrease in fatigue over the course of the study. FIG. 3 shows how the appetite intensity changed over the course of the study. As shown, test subjects using the tested dietary supplement compositions reported a 37% decrease in appetite intensity over the course of the study.
Ivie meets all the limitations of the claims and thereby anticipates the claims.
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.
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.
Claims 1, 6, 8, 9, 11, 13, 16, 18, and 20-24 are rejected under 35 U.S.C. 103 as being unpatentable over Ivie (US 2015/0079199).
Applicant’s Invention
Applicant claims a dietary composition, comprising: a bean extract and/or a mulberry extract; a diary protein, a plant protein, or a combination thereof; a fiber; a chromium; and a cinnamon extract.
Determination of the scope of the content of the prior art
(MPEP 2141.01)
Regarding claims 1, 8, 11, and 15, Ivie teaches a dietary supplement composition is produced to have the ingredients shown in Table 2. The compositions in Table 2 and 3 comprise: Mulberry extract (mulberry extract); whey protein concentrate, whey protein isolate, and calcium caseinate (diary proteins); inulin (fiber); chromium oligofructose complex (chromium); and cinnamon bark extract (cinnamon extract).
Regarding claim 6, Ivie teaches a dietary supplement composition comprises about 10 grams/serving of dairy and/or soy protein, which falls within 5 g to about 40 g of the dairy protein, plant protein per serving (page 8, paragraph 64).
Regarding claim 9, Ivie teaches the dietary supplement composition include less than 10 grams of soluble fiber per serving (page 2, paragraph 9). 10 grams of fiber per serving falls within the range of 3 g to about 25 g of the fiber per serving, currently claimed.
Regarding claim 13, Ivie teaches the dietary supplement composition include between 20 µg to 360 µg of elemental chromium per serving (page 4, paragraph 13). 20 µg to 360 µg of elemental chromium per serving falls within the range of 17 µg to about 600 µg of elemental chromium per serving, currently claimed.
Regarding claim 16, Ivie teaches the dietary supplement composition include between 50 and 600 mg of cinnamon extract per serving (page 5, paragraph 37). 40 mg to about 200 mg of a cinnamon, currently claimed, falls within 50 and 600 mg of cinnamon extract per serving taught by Ivie.
Regarding claim 20, Ivie teaches the dietary supplement composition is incorporated as part of a powdered shake mix (page 10, claim 45).
Ivie teaches the dietary supplement composition include a cinnamon extract that includes phenols. For example, a cinnamon extract incorporated into a dietary supplement composition provided herein can include between 10% and 50% phenols (e.g., between 20% and 40% phenols, between 25% and 35% phenols, between 28% and 32% phenols, or about 30% phenols) (page 4, paragraph 36).
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02)
Ivie does not specifically disclose the cinnamon extract is a 25:1 extract.
Finding a prima facie obviousness
Rationale and Motivation (MPEP 2142-2143)
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to use the teachings of Ivie to determine the result effective amount of cinnamon extract to use in the composition. One of ordinary skill in the art would have been motivated to use experimentation and optimization to determine the amount of cinnamon extract to use in the composition. Ivie teaches the dietary supplement composition include a cinnamon extract that includes phenols. For example, a cinnamon extract incorporated into a dietary supplement composition provided herein can include between 10% and 50% phenols (e.g., between 20% and 40% phenols, between 25% and 35% phenols, between 28% and 32% phenols, or about 30% phenols). Using these teachings one of ordinary skill in the art would have determined the ratio of cinnamon extract to use in the composition. As such, the skilled artisan would have been motivated to use the teachings of Ivie with a reasonable expectation of success, as a person with ordinary skill has good reason to pursue known options within his or technical grasp. Note: MPEP 2141 [R-6] KSR International CO. v. Teleflex lnc. 82 USPQ 2d 1385 (Supreme Court 2007).
Therefore, the claimed invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Claims 1, 3, and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Ivie (US 2015/0079199) in view of Orlowski et al. (US 11,071,767).
Applicant’s Invention
Applicant claims a dietary composition, comprising: a bean extract and/or a mulberry extract; a diary protein, a plant protein, or a combination thereof; a fiber; a chromium; and a cinnamon extract. Applicant claims the dietary composition comprises from about 25 mg to about 500 mg of the bean extract per serving. Applicant claims the bean extract is a Phaseolus vulgaris extract.
Determination of the scope of the content of the prior art
(MPEP 2141.01)
The teachings of Ivie with respect to the 35 U.S.C. 103 rejection is hereby incorporated and are therefore applied in the instant rejection as discussed above.
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02)
Ivie does not specifically disclose the dietary composition comprises a bean extract, as claimed in claim 1, the dietary composition comprises about 25 mg to about 500 mg of the bean extract per serving, as claimed in claim 3 or the bean extract is a Phaseolus vulgaris extract, as claimed in claim 5. It is for this reason Orlowski et al. is added as a secondary reference.
Orlowski et al. teach dietary compositions comprising mulberry extract, coffee extract, bean extract, and optionally, dietary fibers and a nutraceutically acceptable carrier (Abstract).
Orlowski et al. teach the term “bean extract” refers to white kidney bean extract (col. 8, lines 58-62).
Orlowski et al. teach the dietary fibers include oat gum (beta glucan) (col. 9, line 30).
Orlowski et al. teach a method of reducing blood glucose levels comprising administering to the subject in need thereof a dietary composition comprising mulberry extract, coffee extract, bean extract and a nutraceutically acceptable carrier (col. 10, lines 39-44).
Orlowski et al. teach a method of inducing satiety (col. 11, line 19).
Regarding claim 3, Orlowski et al. teach the bean extract is 100 mg per 1 kg body weight (col. 16, lines 26).
Regarding claim 5, Orlowski et al. cite in the “Other Publication” Section the Chen et al. Publication, The anti-obesity effect on rats of α-amylase inhibitor from kidney beans (Phaseolus vulgaris). Food Science and Technology.
Finding a prima facie obviousness
Rationale and Motivation (MPEP 2142-2143)
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to combine the teachings of Ivie and Orlowski et al. and use a bean extract in the composition. Ivie teaches a dietary supplement composition is produced. The compositions in Tables 2 and 3 comprise: Mulberry extract (mulberry extract); whey protein concentrate, whey protein isolate, and calcium caseinate (diary proteins); inulin (fiber); chromium oligofructose complex (chromium); and cinnamon bark extract (cinnamon extract). Ivie teaches that there was a statistically significant reduction (p=0.00005) in serum glucose levels and insulin levels. In addition, Ivie teaches the composition provides an 8% decrease in fasting glucose levels over the course of the study. It would have been obvious to one of ordinary skill in the art to use a bean extract in the dietary composition taught by Ivie because Orlowski et al. teach dietary compositions comprising mulberry extract, coffee extract, bean extract, and optionally, dietary fibers and a nutraceutically acceptable carrier that are used to reduce blood glucose levels and induce satiety. One of ordinary skill in the art would have been motivated to add a bean extract to the composition since Orlowski et al. teach a composition comprising mulberry extract and bean extract used for the same purpose as the dietary composition taught by Ivie. In addition, in view of In re Kerkhoven, 205 USPQ 1069 (C.C.P.A. 1980), it is prima facie obvious to combine two or more compositions each of which is taught by prior art to be useful for the same purpose in order to form a third composition that is to be used for the very same purpose. The idea of combining them flows logically from their having been individually taught in prior art, thus claims that require no more than mixing together two or three glucose reducing compounds set forth prima facie obvious subject matter.
Regarding the limitation of the dietary composition comprises about 25 mg to about 500 mg of the bean extract per serving, Orlowski et al. teach the bean extract is 100 mg per 1 kg body weight. Based on these teachings one of ordinary skill in the art would have been motivated to use the teachings of Orlowski et al. to determine the amount of bean extract to use in the dietary composition.
It would have been obvious to one of ordinary skill in the art to that the bean extract is a Phaseolus vulgaris extract. Orlowski et al. teach the term “bean extract” refers to white kidney bean extract. Orlowski et al. cite in the “Other Publication” Section the Chen et al. Publication, The anti-obesity effect on rats of α-amylase inhibitor from kidney beans (Phaseolus vulgaris). Based on this evidence, it would have been obvious that the white kidney bean extract is Phaseolus vulgaris, with a reasonable expectation of success.
Therefore, the claimed invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Claims 12 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Ivie (US 2015/0079199) in view of Orlowski et al. (US 11,071,767) as applied to claims 1, 3, and 5 above, and further in view of Wang (CN1742628), as evidenced by the Sujithra Publication (2004, International Journal of Biological Macromolecules). English Translation Wang provided by FIT Data Base.
Applicant’s Invention
Applicant claims a dietary composition, comprising: a bean extract and/or a mulberry extract; a diary protein, a plant protein, or a combination thereof; a fiber; a chromium; and a cinnamon extract. Applicant claims the fiber comprises beta-glucan, inulin, and soluble corn fiber.
Determination of the scope of the content of the prior art
(MPEP 2141.01)
The teachings of Ivie and Orlowski et al. with respect to the 35 U.S.C. 103 rejection is hereby incorporated and are therefore applied in the instant rejection as discussed above.
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02)
Ivie and Orlowski et al. do not specifically disclose the fiber comprises beta-glucan, inulin, and soluble corn fiber in combination. It is for this reason Wang and the Sujithra Publication are added as secondary references.
Wang teaches dietary fiber can delay glucose absorption and it is helpful to improve glucose tolerance, preventing diabetes (page 1, Abstract, Translation). Wang teaches the dietary fibre formulation, all the raw materials must be processed by biological method, include soybean fibre, wheat bran fibre, corn fibre, Arabic gum and inulin. Wang teaches the product can reduce blood sugar, generate the digestive protecting screen and can reduce serum cholesterol and triglyceride content (page 2, Specific execution examples, page 4, claims, Translation). Wang teaches when eating dietary fibre, it is capable of delaying stomach emptying time, inhibiting increase of blood sugar, dietary fibre to control postprandial blood glucose, and improve glucose tolerance (page 5, claims, Translation).
The Sujithra Publication teaches β-glucan are high molecular weight, glucose-based polysaccharides that are found in plants such as oats, barley, and wheat (page 1, Introduction, paragraph 1). The Sujithra Publication teach that 59.4% β-glucan is extracted from wheat bran (page 4, Table 2). The Sujithra Publication teaches β-glucan have been extensively studied as the major component of soluble dietary fiber used for the treatment of many diseases. These non-starch polysaccharide compounds have been increasingly consumed as food supplements by diabetic patients. The major food sources of β-glucan include wheat (page 6, col. 2, Biological uses and properties of β-glucan, paragraph 1).
Finding a prima facie obviousness
Rationale and Motivation (MPEP 2142-2143)
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to combine the teachings of Ivie, Orlowski et al., Wang, as evidenced by the Sujithra Publication and use a combination of inulin, beta-glucan, and soluble corn fiber as the fiber component in the compositions taught by Ivie, as modified by Orlowski et al. Ivie teaches a dietary supplement compositions in Tables 2 and 3. The compositions in Table 2 and 3 comprise: Mulberry extract (mulberry extract); whey protein concentrate, whey protein isolate, and calcium caseinate (diary proteins); inulin (fiber); chromium oligofructose complex (chromium); and cinnamon bark extract (cinnamon extract). Ivie teaches that there was a statistically significant reduction (p=0.00005) in serum glucose levels and insulin levels. In addition, Ivie teaches the composition provides an 8% decrease in fasting glucose levels over the course of the study. The compositions comprise a combination of whey protein, whey protein concentrate, and calcium caseinate. Ivie teaches inulin is used as a fiber in the compositions. Orlowski et al. teach dietary compositions comprising mulberry extract, coffee extract, bean extract, and optionally, dietary fibers and a nutraceutically acceptable carrier that are used to reduce blood glucose levels and induce satiety. Orlowski et al. teach the dietary fibers include oat gum (beta glucan). One of ordinary skill in the art would have been motivated to use a combination of inulin, beta-glucan, and soluble corn fiber in the dietary compositions taught by Ivie, as modified by Orlowski et al., because a combination of these fibers are used in other dietary supplements to inhibit increase of blood sugar and improve glucose tolerance. Wang teaches a dietary fiber supplement comprising wheat bran fibre, corn fibre, Arabic gum and inulin that inhibits increase of blood sugar and improve glucose tolerance. As evidenced by the Sujithra Publication wheat bran fibre contains beta-glucan. As such, one of ordinary skill in the art would have found it obvious to use a combination of wheat bran fibre (beta-glucan), corn fibre, and inulin as the fiber component in dietary supplements that improve glucose tolerance. In addition, in view of In re Kerkhoven, 205 USPQ 1069 (C.C.P.A. 1980), it is prima facie obvious to combine two or more compositions each of which is taught by prior art to be useful for the same purpose in order to form a third composition that is to be used for the very same purpose. The idea of combining them flows logically from their having been individually taught in prior art, thus claims that requires no more than mixing together two or three compounds that control improve glucose tolerance.
Therefore, the claimed invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Claims 1 and 2 are rejected under 35 U.S.C. 103 as being unpatentable over Ivie (US 2015/0079199) in view of Cairns (US 2012/0258202).
Applicant’s Invention
Applicant claims a dietary composition, comprising: a bean extract and/or a mulberry extract; a diary protein, a plant protein, or a combination thereof; a fiber; a chromium; and a cinnamon extract. Applicant claims the dietary composition further comprises milk thistle.
Determination of the scope of the content of the prior art
(MPEP 2141.01)
The teachings of Ivie with respect to the 35 U.S.C. 103 rejection is hereby incorporated and are therefore applied in the instant rejection as discussed above.
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02)
Ivie does not specifically disclose the dietary composition further comprises milk thistle. It is for this reason Cairns is added as a secondary reference.
Cairns teaches treatments to reduce caloric intake to raise metabolic rate to compensate for its reduction due to calorie restriction (Abstract). Cairns teaches milk thistle standardized at 80% silymarin in an amount of 300 mg/day with a dose range of 150-450 mg/day used to promote a healthy liver is used in the composition (page 4, paragraph 49).
Finding a prima facie obviousness
Rationale and Motivation (MPEP 2142-2143)
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to combine the teachings of Ivie and Cairns and use milk thistle in the compositions. Ivie teaches a dietary supplement composition is produced. The compositions in Tables 2 and 3 comprise: Mulberry extract (mulberry extract); whey protein concentrate, whey protein isolate, and calcium caseinate (diary proteins); inulin (fiber); chromium oligofructose complex (chromium); and cinnamon bark extract (cinnamon extract). Ivie teaches that there was a statistically significant reduction (p=0.00005) in serum glucose levels and insulin levels. Ivie teaches the test subjects using the tested dietary supplement compositions reported a 37% decrease in appetite intensity over the course of the study. One of ordinary skill in the art would have been motivated to add another compound that is used in a dietary composition to reduce caloric intake, such as milk thistle. As such, in view of In re Kerkhoven, 205 USPQ 1069 (C.C.P.A. 1980), it is prima facie obvious to combine two or more compositions each of which is taught by prior art to be useful for the same purpose in order to form a third composition that is to be used for the very same purpose. The idea of combining them flows logically from their having been individually taught in prior art, thus claims that require no more than mixing together two or three appetite suppressing compounds set forth prima facie obvious subject matter.
Therefore, the claimed invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Andriae M Holt whose telephone number is (571)272-9328. The examiner can normally be reached Monday-Friday, 8:00 am-4:30 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at 571-272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDRIAE M HOLT/Examiner, Art Unit 1614
/ALI SOROUSH/Supervisory Patent Examiner, Art Unit 1614
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