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 1-11, in the reply filed on January 8, 2-26 is acknowledged. The traversal is on the ground(s) that Groups I, II and II are patentably indistinct and form a single inventive concept. This is not found persuasive. MPEP § 808.02 recites that for the purposes of the initial requirement of a restriction, a serious burden on the examiner may be prima facie shown if the examiner shows by appropriate explanation either separate classification, separate status in the art, or a different field of search as defined in MPEP § 808.02. Since the Examiner has shown a different classification for the two groups of claims, a burden for examining both groups has been shown.
The requirement is still deemed proper and is therefore made FINAL.
Claims 12-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected inventions, there being no allowable generic or linking claim.
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 1-9 are rejected under 35 U.S.C. 103 as being unpatentable over Yin et al. (CN 109280630 A; Jan. 29, 2019) in view of Hughes et al. (WO 2010/033915 A1; March 25, 2010).
Regarding claim 1, Yin discloses a micronized composition for improving human immunity comprising a first blend of bovine colostrum powder, corresponding to applicant’s first blend of transfer factor materials, and a second micronized blend of mushroom powder (Derwent Abstract, pages 4-8).
The examiner notes that the claim recites a “blend” and recites transfer factor materials and mushrooms in the plural form, however, the instant specification at [0040] discloses that a blend can be a single ingredient and therefore a single ingredient taught in the prior art is considered to meet applicant’s claimed “blend”. Yin’s teaching of bovine colostrum powders meets applicant’s claimed blend of transfer factor materials and Yin’s teaches of micronized mushroom powder meets applicant’s claimed blend of mushrooms.
While Yin teaches that the bovine colostrum is in powder form, Yin fails to specifically teach that it is micronized. However, it would have been obvious to one of ordinary skill in the art to have the bovine colostrum micronized as Yin teaches that the mushroom powder is micronized as the micronization process greatly improves the body’s ability to absorb and use the component (Derwent Abstract page 7). Therefore, having the bovine colostrum powder micronized would predictably improve the body’s ability to absorb and use it.
Yin teaches that the composition is free of egg yolk.
While Yin teaches a micronized blend of mushrooms, Yin fails to specifically teach that the mushrooms are organic, however, it would have been obvious to use organic mushrooms for the known health and environmental benefits.
Yin further teaches that the micronized mushroom powder has a particle size 5-15 microns (Derwent Abstract page 6), which overlaps the claimed average particle diameter of less than about 8 microns. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. (MPEP 2144.05 I)
As Yin teaches that the micronization process provides a particle size of 5-15 microns, it would have been obvious for the bovine colostrum powder to also have such particle size as Yim teaches that such particle size is suitable for improving the body’s ability to absorb and use the composition.
While Yin renders obvious the micronized composition as described above, Yin fails to further teach the composition comprising micronized gallic acid derived from at least one natural food source.
Hughes discloses a nutrient composition comprising phytonutrients as they support the immune and cardiovascular system, control blood sugar levels, cholesterol levels and body weight. Hughes teaches that gallic acid is a phytonutrient that can be used in the composition, wherein it is derived from a natural plant source ([0027-0031]).
It would have been obvious to one of ordinary skill in the art to further add gallic acid to the composition of Yin in order to further provide the composition of Yin with components to increase immunity in an individual.
As stated in MPEP 2144.06 ““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) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.)”
It would have been obvious to further have the gallic acid micronized as taught by Yin so that it is better absorbed and used by the body. Yin teaches that the micronization process provides a particle size of 5-15 microns (Derwent Abstract page 6), which is considered to overlap the claimed range of less than about 8 microns, and therefore would have been obvious to micronize the gallic acid of Hughes to a similar particle size as Yin teaches that such particle size is suitable for improved absorption and use in the body. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. (MPEP 2144.05 I)
Regarding claim 2, as stated above, Yin teaches that the micronization process provides a particles size of 5-15 microns (Derwent Abstract page 6), which is considered to overlap the claimed range of less than about 5 microns. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. (MPEP 2144.05 I)
Regarding claim 3, as stated above, Yin teaches that the first micronized blend of transfer factor materials, i.e. the bovine colostrum powder, is present in an amount of 5-10 parts by weight (Derwent Abstract pages 4-5), which falls within the claimed range of 0.1 to 35% by weight.
Further, it would have been obvious to one of ordinary skill in the art to vary the amount of bovine colostrum powder depending on the desired effect of the composition. As stated in MPEP 2144.05: Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "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)
Regarding claims 4-5, Yin teaches that the first micronized blend (i.e. the bovine colostrum powder) and the second micronized blend (i.e. the mushroom powder) are present at a ratio of 1:1 (e.g. 5-10 parts by weight of each: Derwent Abstract). Yin in view of Hughes further teach the addition of gallic acid. Yin and Hughes, however, fail to teach an amount of gallic acid present to teach the claimed ratio of the three components.
It would have been obvious to one of ordinary skill in the art to combine the three micronized components in a desired ratio so as to maximize the functional effect or sensory characteristics of the nutritional supplement. All are known sources for nutrition and providing immunity and therefore it is well within the ordinary skill in the art to vary the amount of each to determine the optimum ratio for achieving a desired effect.
As stated in MPEP 2144.05: Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "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)
Therefore, absent a showing of criticality, the claimed ratio is merely an obvious variant over the prior art and well within the ordinary skill to determine through routine experimentation.
Regarding claim 6, Yin further teaches that the composition comprises whey protein polypeptides (Derwent Abstract), which is considered to meet the claimed blend of amino acids as a polypeptide is a chain of amino acids.
With respect to the blend being micronized, it would have been obvious to one of ordinary skill in the art to have the whey protein polypeptides micronized as Yin teaches that it would improve the body’s ability to absorb and use it.
Regarding claim 7, as stated above with respect to claim 6, Yin teaches the addition of whey protein polypeptides, which are amino acids. Therefore, as Yin meets the claimed blend of amino acids in claim 6, whey protein itself is not required as the claim fails to recite that the composition further comprises whey protein.
Regarding claim 8, as stated above with respect to claim 6, Yin teaches a blend of amino acids and renders obvious a micronized blend of amino acids, which corresponds to applicant’s third micronized blend. Micronized quercetin is optional and therefore not required.
Yin teaches that the micronization process provides a particles size of 5-15 microns (Derwent Abstract page 6), which is considered to overlap the claimed range of less than about 10 microns. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. (MPEP 2144.05 I)
Regarding claim 9, as stated above, Hughes discloses a nutrient composition comprising gallic acid as a phytonutrient, wherein the phytonutrients are derived from natural plant source including blueberries ([0027]-0031]). It would have been obvious to one of ordinary skill in the art to have the micronized gallic acid derived from wild blueberries as Hughes teaches that blueberries are a known phytonutrient source.
Claims 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Yin et al. (CN 109280630 A; Jan. 29, 2019) in view of Hughes et al. (WO 2010/033915 A1; March 25, 2010) as applied to claim 1 above, and further in view of Simon et al. (KR 20200023053 A; March 4, 2020).
Regarding claim 10, the prior art discloses the composition as described above, rendering obvious a micronized composition for improving immunity, but fails to further teach micronized particles of quercetin having an average particle diameter of less than about 10 microns.
Simon discloses a powder supplement effective for improving immunity, wherein the supplement comprises quercetin (Derwent Abstract pages 5-8). Simon teaches that quercetin is a polyphenol that has various effects, including weight control, blood lipid improvement, and antimicrobial effect (Derwent Abstract pages 4-5).
It would have been obvious to one of ordinary skill in the art to further include quercetin in the composition of Yin so as to provide the composition of Yin with further immunity and various effects as taught by Simon.
It would have been obvious to further have the quercetin micronized as taught by Yin so that it is better absorbed and used by the body. Yin teaches that the micronization process provides a particles size of 5-15 microns (Derwent Abstract page 6), which is considered to overlap the claimed range of less than about 10 microns, and therefore would have been obvious to micronize the quercetin of Simon to a similar particle size as Yin teaches that such particle size is suitable for improved absorption and use in the body. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. (MPEP 2144.05 I)
Regarding claim 11, Simon further teaches combining quercetin with other raw materials in an optimum ratio to maximize the functional effect or sensory characteristics of the nutritional supplement (Derwent Abstract page 6) and therefore it would have been obvious to one of ordinary skill in the art to determine the optimum amount of quercetin to add to the composition of Yin so as to maximize the functional effect or sensory characteristics of the nutritional supplement.
As stated in MPEP 2144.05: Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "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)
Therefore, absent a showing of criticality, the claimed amount of quercetin is merely an obvious variant over the prior art and well within the ordinary skill to determine through routine experimentation.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEPHANIE A KOHLER whose telephone number is (571)270-1075. The examiner can normally be reached Monday-Friday 8am-5pm.
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/STEPHANIE A KOHLER/Primary Examiner, Art Unit 1791