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, 13-21, 24, 26, 28, 33, and 46-51 are pending in this application.
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.
Claim 15, 24, 26, 28 and 49 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.
(1) In claim 15, “chloride 6 hydrate” and “dicrate” are confusing. First, it is not clear whether 6 hydrate refers to hexahydrate or some other configuration of molecules. Second, “dictrate” is a misspelling. Corrections are required.
(2) Claims 24, 26, and 28 recite “formulated so as to provide a daily dose of ….” It is confusing how the formulation is so tied to a daily dose. Unless the composition is claimed as a unit dosage form, the daily dose depends on how much of the composition is administered, not the composition itself.
(3) In claim 49, it is not clear what a “sports person” is. The term is ambiguous and could refer to many different people, such as an athlete, a fan who is not an athlete, a broadcast announcer, or an owner of a sports team.
35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 24, 26, and 28 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claims 24, 26, and 28 recite a composition “formulated so as to provide a daily dose of ….” A daily dose is a method feature in the absence of a specific unit dosage form, which these claims do not have. Therefore, the method feature does not further limit the composition of their base claims.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
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.
Claims 1, 20, 21, 24, 26, 28, 33, and 46-48 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CN 114698852.1
CN 114698852 discloses in Examples 1 and 2 compositions comprising a prebiotic and probiotic, wherein the prebiotic includes 17 g inulin and 1 g xylooligosaccharide, and 0.05 g magnesium stearate, and probiotic includes 0.04 g Bifidobacterium lactis. See also claims 4-6 for similar proportions. Promotion of survival and growth of probiotics is disclosed (page 1 of translation, first paragraph under “Background technique”; page 2 of translation, lines 16-20; page 3 of translation, last paragraph; page 4 of translation). Capsule form is claimed (claim 8).
The claims are thereby anticipated. Regarding claims 24, 26, and 28, daily dose is a method feature which does not further limit the composition per se.
Claims 1, 24, 26, 28, 46-47, 49, and 50 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CN 110214936.2
CN 110214936 discloses a nutritional composite powder that contains 3-9 parts inulin, 0.05-1.5 parts xylooligosaccharide, and 0.78-0.8 parts magnesium (claim 1). Composite powder that contains 6 part inulin, 1 part xylooligosaccharide, and 0.781 part magnesium is also disclosed (claim 2). Example 3 shows administration to a 51 year old male in combination with exercise. Example 4 shows increase of lactobacteria after treatment (original document paragraph 42, translated below):
[0042]
Group Lactic acid bacteria E. coli
Before test 8.77 7.86
After test 9.63 7.01
See also the translation of all of Example 4.
The claims are thereby anticipated. Regarding claims 24, 26, and 28, daily dose is a method feature which does not further limit the composition per se.
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, 13-21, 24, 26, 28, 33, and 46-51 are rejected under 35 U.S.C. 103 as being unpatentable over CN 110214936 in view of WO 02/39835, Frippiat et al. (US 20030068429), and Poletto et al.
CN 110214936 discloses a nutritional composite powder that contains 3-9 parts inulin, 0.05-1.5 parts xylooligosaccharide, and 0.78-0.8 parts magnesium (claim 1). Composite powder that contains 6 part inulin, 1 part xylooligosaccharide, and 0.781 part magnesium is also disclosed (claim 2). Example 3 shows administration to a 51 year old male in combination with exercise. Example 4 shows increase of lactobacteria after treatment (original document paragraph 42, translated below):
[0042]
Group Lactic acid bacteria E. coli
Before test 8.77 7.86
After test 9.63 7.01
See also the translation of all of Example 4. The composition combined with exercise can provide various benefits, including improving intestinal damage (page 3 of the translation, first paragraph).
WO 02/39835 discloses that magnesium supplied by food is often below the recommended daily amounts, which is around 6 mg per kg per day (page 2, 4th paragraph). Chronic magnesium deficiency can result in chronic fatigue and signs of neuromuscular hyper-excitability analogous to those described under latent tetany and hyperventilation syndrome (id.). WO 02/39835 teaches that magnesium absorption is increased by indigestible oligosaccharides such as xylooligosaccharides and fructans such as inulin, and mixtures thereof (page 3, 2nd paragraph in view of last paragraph of page 1 for inulin as fructan). Magnesium can be present in 1-20 wt% (page 3, first paragraph). Magnesium citrate is disclosed a suitable magnesium salt to use; other water soluble magnesium slats are disclosed (page 6, 3rd full paragraph). 250 mg of magnesium is disclosed (page 9, line 5; page 11, 4th paragraph). Indigestible oligosaccharide is administered in a daily dose of between 1-20 g/kg of body weight (page 3, 5th paragraph; claim 7). Capsule delivery form is disclosed (page 4, first paragraph; claim 11). The indigestible oligosaccharides can be present in an amount between 1-99 wt% (or 2-90 wt%, 5-80 wt%, or 20-50 wt%), and magnesium can be present in an amount between 1-20 wt or 3-10 wt% (claims 1-6).
Frippiat et al. (US 20030068429) disclose that inulin from chicory is well known and commercially available (paragraph 11), and inulin has a strong bifidogenic effect because inulin selectively stimulates the growth and metabolic activity of Bifidobacteria and lactobacilli, while reducing the count of undesirable bacteria (paragraph 190.
Poletto et al. disclose that corn is a well-known source of xylooligosaccharides (pages 352-354, 358-360). The 5-carbon sugar xylooligosaccharide has the advantage of being fermented by the beneficial bacteria Bifidobacterium and Lactobacillus, while 6-carbon sugars are used by both beneficial and some pathogenic bacteria (page 352). Stimulation of growth of Bifidobacteria and lactobacilli is disclosed (page 354).
CN 110214936 does not explicitly disclose all the dependent claim features as set forth in the instant application, but they would have been obvious for the reasons discussed below.
Claims 13-14 recite the source of inulin as chicory and source of XOS (xylooligosaccharides) as maize. These are well-known, obvious sources of inulin and XOS, as evidenced by Frippiat et al. and Poletto et al.
Claim 15 recites magnesium in the form of chloride, possibly chloride hexahydrate, citrate, or hydrogen citrate. Although CN 110214936 does not explicitly mention such magnesium compounds, CN 110214936 disclose magnesium without any limitation. Further, WO 02/39835 suggests magnesium citrate and other soluble magnesium salts. Therefore, the ordinary skilled artisan would have found it obvious to use common magnesium compounds such as those recited in the claim to provide the magnesium of CN 110214936.
Claim 16 requires inulin to XOS ratio of about 4:1 to about 1:1, and claim 17 requires a ratio of about 2:1. CN 110214936 teaches 3-9 parts inulin and 0.05-1.5 parts xylooligosaccharide, so the claimed ratio such as about 4:1, about 3:1, or about 2:1 would have been obvious.
Claim 18 requires inulin, XOS, and Mg to be present in a ratio of about 6.5:3:1. The disclosed amount ranges by CN 110214936 are 3-9 parts inulin, 0.05-1.5 parts xylooligosaccharide, and 0.78-0.8 parts magnesium, which would encompass the claimed ratio. Further, WO 02/39835 suggests the claimed weight ratio of mixture of indigestible oligosaccharides to magnesium.
Claim 19 requires presence of inulin at about 0.6-4 g, claim 20 requires presence of XOS at about 0.4-2.6 g, and claim 21 requires presence of magnesium at about 18-120 mg, about 18-85 mg, or about 0.25-0.75 g. The ordinary skilled artisan, having been taught the proportions by which the ingredients are to be mixed, would have found it obvious to obtain various compositions that have target amounts of inulin XOS, and magnesium, whether as a unit dose, partial dose, or as forms that can be divided into several or more doses.
Regarding claims 24, 26, and 28, daily dose is a method feature which does not further limit the composition per se.
Claim 33 requires a capsule form. It would have been obvious for the ordinary skilled artisan to formulate or repackage a powder into many different conventional delivery forms, including a capsule form for ease of handling or unit dosing, as further evidenced by WO 02/39835.
Claim 46 and claims dependent thereof are directed to a method of improving gastrointestinal microbiota and maintaining and/or improving gut barrier integrity in an individual. CN 110214936 discloses increase of lactobacteria after treatment; and Frippiat et al. (US 20030068429) and Poletto et al. establish that inulin and XOS would stimulate the growth of beneficial bacteria such as Bifidobacteria and lactobacilli.
Claim 49 requires the subject to be “sports person,” athlete, or a person undergoing a high protein diet regimen. CN 110214936 exemplifies administration to a 51 year old, who exercised every day (Example 3).
Therefore, the claimed invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, because every element of the invention and the claimed invention as a whole have been fairly disclosed or suggested by the teachings of the cited references.
For the foregoing reasons, all claims are rejected.
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to JOHN PAK whose telephone number is (571)272-0620. The Examiner can normally be reached on Monday to Friday from 8:30 AM to 5 PM.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner's SPE, Fereydoun Sajjadi, can be reached on (571)272-3311. The fax phone number for the organization where this application or proceeding is assigned is (571)273-8300.
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/JOHN PAK/Primary Examiner, Art Unit 1699
1 Cited in the IDS of 1/9/2025.
2 Submitted in the IDS of 1/9/2025.
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