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 .
The reply filed 12-5-2025 has been entered into the record.
Status of Claims
Claims 1-18 are pending.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Election/Restrictions
Applicant’s election of Group I in the reply filed on 12-5-2025 without traverse is acknowledged. Claims 1-11 and 18 are under examination. Claims 12-17 are withdrawn from consideration.
Information Disclosure Statement
The information disclosure statement has been considered. An initialed copy is enclosed.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
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.
Claims 1-11 and 18 are rejected under 35 U.S.C. 112(a), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a written description rejection.
The claims are drawn to synergistic combinations of stabilizer wherein the stabilizer comprises at least one first and second protectant where the first and second protectant are different and selected from the group consisting of oligofructans, maltodextrin, inulin and pea fiber. The specification teaches specific combinations and amounts of oligofructans, maltodextrin, inulin and pea fiber. Synergy is defined at the paragraph bridging pages 6-7 of the specification. Basically, any combination in any amount under any condition(s) providing for better stability than the additive combination of the single ingredients. The teachings of the specification are limited to a comparison with high variability between trials. For example, compare single ingredients of Figure 1 with Figure 2, trehalose, maltodextrin and oligofructose in particular. There is a substantial difference in stability between the two experiments where Figure 1 as compared to Figure 2. No synergy would be shown in Figure 1 wherein maltodextrin appears to have the same stability as the combination of maltodextrin and oligofructose in Figure 2. Thus, absent defined parameters, conditions and amounts under which synergy is specially determined and given the large inter-experiment variability the specification does not provide a representative number of combinations, conditions and amounts to represent the genus of combinations that have synergy.
The courts have also held that a sufficient number of representative species must be included “to demonstrate that the patentee possessed the full scope of the [claimed] invention.” Lizardtech, Inc. v. Earth Resource Mapping, Inc. 424 F.3d 1336, 1345, 76 USPQ2d 1724, 1732 (Fed. Cir. 2005). Although the disclosure would put the skilled artisan in possession of multiple different combinations of ingredients, weights, stability conditions, those specific concentrations and combination of stabilizers which that may or may not have synergistic activity, the level of skill and knowledge in the art is such that one of ordinary skill would not be able to identify without further testing, which of those compositions, combination of elements, weights of each stabilizer/protectant have the claimed synergistic activities. Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, makes clear that “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed.” (See page 1117.) The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed.” (See Vas-Cath at page 1116.). Applicants are directed to MPEP 2163. As such, the skilled artisan would not readily appreciate from the comparison that Applicants were in possession of the now claimed invention. The courts have held that possession of a genus may not be shown by merely describing how to obtain members of the claimed genus (i.e. make and test to see if they lack the requisite synergistic activity). See University of Rochester, 358 F.3d at 927, 69 USPQ2d at 1895 and In re Kubin, 90 USPQ2d 1417 (Fed. Cir. 2009). When the genus is large and the specification lacks a known (art described) or disclosed correlation between structure and synergistic function, the written description of the specification does not convey possession of the claimed genus.
Claim 18 is rejected under 35 U.S.C. 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
As to claim 18, the claim provides for a beverage comprising the composition of claim 1. A beverage is conventionally wet so it cannot comprise a “dry” composition. The claim is internally inconsistent.
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.
Claims 1, 3-11 and 18 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Naidu et al (US 2006/0269535; of record on 1449).
Naidu et al teach a dry formulation designed to facilitate weight loss having probiotic organisms of at least on LAB strain with effective dosages of 102-1012 CFU (see paragraphs [0144-0145]). The compositions may be provided in a variety of formats, including but not limited to liquid, powder, protein bare or trail mix forms (see paragraphs [0028] and [0081], examples 11-12 and Table 10). Naidu et al exemplify the formulation in Table 11, which have a combination of maltodextrin, Inulin, Lactobacillus spp. 50 billion CFU/gm and Bifidobacterium spp. 50 billion CFU/g (see page 14, column 2), citric acids , oligofructans etc. wherein the composition may be in a freeze-dried powder formulation (see paragraph [0143]). Solid formulations can include solid carriers such as pectin (see paragraph [0081]). Inasmuch as the composition contains both maltodextrin, inulin, Lactobacillus sp and Bifidobacterium sp, citric acid, the combination is synergistic absent factual evidence to the contrary.
Claims 1, 2, 4, 5, 7-11 and 18 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Showell et al (WO 2019/152524, priority to January 30, 2019; of record on 1449).
Showell et al teaches a dry composition containing i) 0.5% or less by weight of a bacterial composition containing one or more lactic-acid-producing bacteria comprising Lactobacillus plantarum and Pediococcus sp. having a bacterial concentration of at least 1x 106 colony forming units (CFU) per gram of the bacterial composition and ii) at least 95% by weight of a diluent (see paragraph [0055]). The composition can comprise one or more latic-acid-producing bacteria in addition to various Bacillus sp. strains (see paragraphs [0049-0050]). The diluent comprises a plurality of monosaccharides units connected by a plurality of linkages, wherein at least 70% of the linkages are beta-glycosidic bonds. The compositions have at least 80% of the bacteria activity in the dry composition retained over a period of 30 days at room temperature. The dry composition comprises less than 1% by weight water (see paragraph [0053]). The dry composition comprises vitamin E which is an antioxidant. Embodiments may also include prebiotics (inulin, fructooligosaccharide, a glucooligosaccharide) and postbiotics. Exemplary diluents where at least 70% of the linkages between monosaccharide units are glycosidic bonds that are resistant to hydrolysis by an amylase include digestion resistant maltodextrin, inulin and starch or a combination thereof (see paragraphs [0004-0022}, [0059], claims 11, and 28-31). Showell et al teaches when formulated for animal feed, the dry composition can be formulated into feed mash, pellets or added to the water supply. The dry compositions are typically dosed between 0.1 and 2 kg per metric ton of feed (see paragraphs [0077-0078]). Inasmuch as the composition contains both maltodextrin, inulin, Lactobacillus sp and further comprises vitamin E as an antioxidant, the combination is synergistic absent factual evidence to the contrary.
Claims 1, 3-11 and 18 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Harel et al (WO 2012/021783; of record on PTOL-1449).
Harel et al teach a dry composition comprising probiotic bacteria including lactic acid bacteria such as Lactobacillus, Streptococcus, Leuconostoc and Oenococcus and a mixture of di-, oligo- and poly-saccharides. Specific bacteria contemplated are identified at paragraph [0012] and include numerous species corresponding to instant claims 5 and 6, considering the nomenclature update as set forth in page 10 of the instant specification as reported by Zheng et al cited therein. Examples of suitable polysaccharides include pectin, starches and modified starches. Examples of oligosaccharides include inulin, fucooligosaccharides (FOS), maltodextrins, dextrans and combinations thereof (see page 5, paragraph [0013]). See in particular The composition further comprises an organic acids like citric acid and its salts and ascorbic acid and its salts (citric and ascorbic salts/acids are antioxidants), the preferred total amount in the dry composition is such that the molar ration of ions to moles of carbohydrates is from 0.01 to about 0.3 and most preferably from about 0.1 to about 0.2 (paragraph [0015]). The final drying step of the material under full vacuum pressure for a time sufficient to reduce the water activity of the dried formation to 0.3 Aw or less (paragraph [0020]). The dried and stable composition can be used directly as a fake or grounds into a power4ed. The formulation can be administered directed to an animal as a concentrate powder, reconstituted liquid or incorporated int an existing food or feed product (see paragraph [0021]). Probiotic bacteria benefit particularly from the compositions and drying methods of the invention. Such compositions can remain stable in harsh storage conditions such as 40oC and 33%RH for 60 days or more (paragraph [0047]). Harel et al teach that the oligosaccharides mitigate the use of trehalose alone and are very effective stabilizers for storage stability for extended periods of time, especially at high temperatures and/or humid environments. The storage stability is resolved with the addition of oligosaccharides to the carbohydrate mixture. The mass ratio of the saccharides is disclosed (see paragraphs [0052-0053], [0057-0058]). See also claims 7-16. The combination is synergistic absent factual evidence to the contrary.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Patricia Duffy whose telephone number is (571)272-0855. The examiner can normally be reached 8:00 am - 4 pm.
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/Patricia Duffy/Primary Examiner, Art Unit 1645
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