DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s amendment and response filed on 3/3/2026 have been received and entered into the case. Claims 1, 3-5 and 9 have been canceled. Claims 2, 6-8 and 10-12 are pending, Claims 6 and 10-12 have been withdrawn, and Claims 2 and 7-8 have been considered on the merits. All arguments have been fully considered.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112:
(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 (pre-AIA ), first paragraph:
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 of carrying out his invention.
Claims 2 and 7-8 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contain 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 inventors or a joint inventor, or for pre-AIA the inventor(s), before the effective filing date of the application, had possession of the claimed invention.
According to MPEP, a claim term is functional when it recites a feature "by what it does rather than by what it is" (e.g., as evidenced by its specific structure or specific ingredients). A functional limitation is often used in association with an element, ingredient, or step of a process to define a particular capability or purpose that is served by the recited element, ingredient or step.
Claim 2 recites a liquid composition consisting of: probiotic bacteria selected from the Bacillus subtilis, Bacillus clausii, and Bacillus coagulans, genus Lactobacillus, and mixtures thereof; at least 60% sweetener weight by volume that includes sucrose, and one or more excipients selected from the group consisting of hydrophilic vehicles, solubilizer, pH modifier, buffer, viscosity modifier, and preservatives, wherein the probiotic bacteria in the liquid composition retains at least 75% of its cellular viability of the original value as measured by spore count after 6 to 24 months at 30℃ ± 2℃ and a relative humidity of 75% ± 5%. The limitation of “the probiotic bacteria in the liquid composition retains at least 75% of its cellular viability of the original value as measured by spore count after 6 to 24 months at 30℃ ± 2℃ and a relative humidity of 75% ± 5%” is regarded as a functional limitation. Since the relationship between specific ingredients and the claimed function is not clearly established, claim 2 fails the written description requirement. Taking honey as an example, it is well-known in the art that honey is a liquid composition consisting of at least 60% sweetener that includes sucrose and one or more excipients, see page 1 of Wheeler (Sci Rep. 2014;4:5726.), and that honey possess antimicrobial property, see Abstract of Mandal (Asian Pac J Trop Biomed. 2011;1(2):154-160.). Probiotic bacteria in honey would read on claim 2, but would not meet the claimed functional limitation. Thus, the written description requirement has not been satisfied.
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 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 of this title, 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.
Claims 2 and 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Penhasi (WO 2014/170904 A1; 10/23/2014.) in view of Penhasi (US 2013/0323362 A1; 12/5/2013.), Sorokulova et al (Biotechnol. Prog. 2008;24:1147-1153.), and Bashan et al (Plant Soil. 2014;378:1-33.).
The instant claims recite a liquid composition consisting of: probiotic bacteria selected from the Bacillus subtilus, Bacillus clausii, and Bacillus coagulans, genus Lactobacillus, and mixtures thereof; at least 60% sweetener weight by volume that includes sucrose, and one or more excipients selected from the group consisting of hydrophilic vehicles, solubilizer, pH modifier, buffer, viscosity modifier, and preservatives, wherein the probiotic bacteria in the liquid composition retains at least 75% of its cellular viability of the original value as measured by spore count after 6 to 24 months at 30℃ ± 2℃ and a relative humidity of 75% ± 5%.
Penhasi (WO) teaches a liquid food product comprising granules with heat and humidity resisting probiotic bacteria (Title, p.22 line 15-20, p.36 line 10-14), and a substrate (p.2 line 16-17) including sweetener that comprises sucrose (p.33 line 4-17), and an excipient which may be at least one of a solubilizer and a buffering agent (p.26 line 25-26), wherein examples of probiotic bacteria include Bacillus coagulans GBI-30, 6086, Bacillus subtilis var natt, and Lactobacillus spp. (p.35 line 9-10 & 18-28). Penhasi (WO) teaches probiotic compositions providing viable probiotic organisms even after heating at relatively high temperatures at high humidity, the composition being further stable on storage (p.10 line 28-31). Penhasi (WO) teaches the liquid food product is an extended shelf-life for ready-to-use liquid infant formula, containing probiotics that remain viable both during the production process and throughout shelf-life (p.11 line 7-9, p.12 line 17-19), the resulting liquid infant formula still have a high level of viable probiotics (p.14 line 10-11).
Penhasi (WO) does not teach at least 60% sweetener weight by volume (claim 2).
However, Penhasi (WO) does teach the liquid food product comprises probiotic bacteria and a substrate (p.2 line 16-17), wherein the substrate includes sweetener that comprises sucrose (p.33 line 4-17). Penhasi (US) teaches a food product comprising probiotic bacteria (Abstract), wherein the probiotic bacteria is mixed with a sugar includes sweetener that comprises sucrose, and the sugar is a supplemental agent with a nutritional and/or protective role (para 0047-0048).
Thus, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to optimize the concentration of sweetener that includes sucrose as a matter of routine experimentation, since Penhasi (WO) and Penhasi (US) both disclose a probiotic composition comprises probiotic bacteria and sweetener that includes sucrose, and Penhasi (US) discloses sweetener that includes sucrose provides nutrition and/or protection for probiotic bacteria. Generally, differences in concentration will not support patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. (MPEP 2144.05 II) Moreover, before the effective filing date of the claimed invention, one of ordinary skill in the art would have been motivated by the cited reference and routine practice to optimize the concentration of sweetener that includes sucrose with a reasonable expectation for successfully obtaining a probiotic composition.
References cited above do not teach the probiotic bacteria in the liquid composition retains at least 75% of its cellular viability of the original value as measured by spore count after 6 to 24 months at 30℃ ± 2℃ and a relative humidity of 75% ± 5% (claim 2) as well as the claimed spore count (claim 7).
However, Penhasi (WO) does teach the liquid food product comprises probiotic bacteria and a substrate (p.2 line 16-17), wherein the probiotic bacteria include Bacillus (p.35 line 10) and the substrate includes acacia gum (p.33 line 27-28). In addition, Penhasi (WO) does teach probiotic compositions providing viable probiotic organisms even after heating at relatively high temperatures at high humidity, the composition being further stable on storage (p.10 line 28-31). Finally, Penhasi (WO) does teach the liquid food product is an extended shelf-life for ready-to-use liquid infant formula, containing probiotics that remain viable both during the production process and throughout shelf-life (p.11 line 7-9, p.12 line 17-19), and the resulting liquid infant formula still have a high level of viable probiotics (p.14 line 10-11). Sorokulova teaches various Bacillus strains are known for their roles as probiotics for humans and animals, biopesticides, bioinsecticides, and biological indicators (p.1147 col left – para 1). Sorokulova teaches formulation of Bacillus spores with acacia gum can protect 90% of spores even after 2 years of storage at 20℃ (p.1152 col left – last para), and such finding shows the possibilities for new probiotic formulations which can keep high rate of strain viability even under ambient temperatures (p.1152 col right – para 1 & 3). Furthermore, Bashan teaches liquid formulations allow the manufacturer to include sufficient amounts of nutrients, cell protectants, and inducers responsible for cell/spore/cyst formation to improve performance, and shelf life of a liquid formulation could be as high as 2 years (p.10 col right – para 2). Bashan teaches liquid inoculants contain concentrations of 2x109 cells per mL (p.10 col right – para 2), longer shelf life can be obtained by increasing the number of microbes in the inoculant, and use of additive in the formulation increases growth during storage (p.24 col left – last para, col right – first para).
Thus, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to obtain a liquid composition comprising probiotic bacteria, wherein the probiotic bacteria in the liquid composition retains at least 75% of its cellular viability of the original value as measured by spore count after 6 to 24 months at the claimed storage conditions, since Penhasi (WO) and Sorokulova both disclose probiotic compositions comprise probiotic bacteria and additives that are useful for improving shelf-life, Penhasi (WO) discloses the probiotic compositions providing viable probiotic organisms even after heating at relatively high temperatures at high humidity, the liquid food product is an extended shelf-life for ready-to-use liquid infant formula, and the resulting liquid infant formula still have a high level of viable probiotics, Sorokulova discloses the possibilities for creating probiotic formulations with prolonged shelf-life, and Bashan discloses advantages of a liquid formulation, and shelf life of the liquid formulation could be as high as 2 years. In addition, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to optimize the concentration of the spore count of probiotic bacteria, since Bashan discloses that liquid inoculants commonly contain concentrations of 2x109 cells per mL, and that longer shelf life can be obtained by increasing the number of microbes in the inoculant. Generally, differences in concentration will not support patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. (MPEP 2144.05 II) Moreover, before the effective filing date of the claimed invention, one of ordinary skill in the art would have been motivated by the cited references to obtain a liquid composition comprising probiotic bacteria retains at least 75% of its cellular viability of the original value as measured by spore count after 6 to 24 months at the claimed storage conditions, with a reasonable expectation of success.
Response to Arguments
Applicant argues that the claimed viability results as a consequence of preparing the claimed composition. In particular, the specification states that, "[i]t has been now found that liquid compositions comprising probiotic bacteria of the genera bacillus/lactobacillus, are stable at ambient storage conditions in the presence of sweeteners such as sugars which constitute at least 60% by weight of the liquid compositions comprising probiotic bacteria. and "the formulation of the invention comprises at least 60% sweetener, which does not promote the growth of bacterial spores." See paragraphs [0020] and [0026], respectively.
These arguments are not found persuasive because although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. Rejected claims are directed to a composition, not a preparation process of the composition. In addition, para 0020-0026 in the instant specification do not disclose “the probiotic bacteria in the liquid composition retains at least 75% of its cellular viability of the original value as measured by spore count after 6 to 24 months at 30℃ ± 2℃ and a relative humidity of 75% ± 5%” as claimed, para 0022 discloses a liquid composition comprises yeast, and para 0024 discloses the bacteria of the invention is selected from the group consisting of genera Bacillus, which are different from the claimed probiotic bacteria.
Applicant argues that the instant claims are drawn to a stable liquid probiotic composition in which the probiotic is not encapsulated in a protective coating. Additionally, none of the cited references teach or suggest a stable probiotic composition including relatively high levels of sweeteners including sucrose for protection of the free (i.e., uncoated) probiotic bacteria in the liquid composition.
These arguments are not found persuasive because applicant’s arguments regarding “the probiotic is not encapsulated in a protective coating” appear to have no connection to the subject at issue, since rejected claims are directed to a liquid composition consisting of: probiotic bacteria selected from the Bacillus subtilus, Bacillus clausii, and Bacillus coagulans, genus Lactobacillus, and mixtures thereof; at least 60% sweetener weight by volume that includes sucrose, and one or more excipients selected from the group consisting of hydrophilic vehicles, solubilizer, pH modifier, buffer, viscosity modifier, and preservatives. In addition, Penhasi (WO) and Penhasi (US) both teach a probiotic composition comprises probiotic bacteria and sweetener that includes sucrose, and Penhasi (US) does teach sweetener that includes sucrose provides nutrition and/or protection for probiotic bacteria, a motivation to optimize the amount of sweetener. Finally, according to MPEP 2144.05 II, differences in concentration will not support patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical, and applicant failed to provide evidence supporting the criticality of the claimed concentration.
Applicant argues that Sorokulova does not teach or suggest stable liquid compositions comprising the claimed amounts of sweetener, or sucrose, and that Bashan does not disclose probiotic bacteria but discloses bacteria for plant growth promotion.
These arguments are not found persuasive because Sorokulova is relied upon to demonstrate the functional limitation of the probiotic bacteria in the liquid composition as recited in claim 2, and Bashan is relied upon to demonstrate the claimed spore count in claim 7.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNN Y FAN whose telephone number is (571)270-3541. The examiner can normally be reached on M-F 7am-4pm.
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/Lynn Y Fan/
Primary Examiner, Art Unit 1759
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