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 .
Claim Status
Claims 1-2, 6, and 8-9 are currently pending and have been examined on the merits.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01/21/2026 is in compliance with the provisions of 37 C.F.R. 1.97. All references cited in this IDS have been fully considered.
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.
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.
Previous rejection under 35 U.S.C. § 103
RE: Rejection of claims 1-2, 6, and 8-9 under 35 U.S.C. 103 as being unpatentable over Rogovin et al. (US 2018/0235271 A1; cited previously) in view of Ogawa et al. (US 2008/011515 A1; cited previously), as evidenced by Kanetani et al. (JP 2010168306 A; English Machine Translation).
Applicant traverses the rejection of record by arguing the following.
First, applicant asserts that “it appears…that the Office believes that calcium phosphate is a surfactant” (Remarks, p. 5, par. 2). Applicant underscores that calcium phosphate is not a surfactant. Specifically, applicant argues that the calcium phosphate used in Rogovin and the surfactants taught by Ogawa are “quite different from each other in their chemical nature, characteristic, and structure” (Remarks, p. 5, par. 3). Hence, applicant asserts that there would have been no motivation or rational reason to substitute calcium phosphate with glycerin fatty acid esters having an HLB of less than 7 and arrive at the claimed invention with a reasonable expectation of success.
Second, applicant asserts that the rejection is constructed through impermissible hindsight because the references do not suggest the claimed combination or modification. To this end, applicant asserts that the examiner has not “identified an articulated reason why a person of ordinary skill in the art would have been motivated to modify or combine the reference in the specific way required by the claims” (Remarks, p. 5, par. 5).
Third, applicant argues that although the Office Action asserts that it would have been obvious to have substituted the anti-caking agent taught by Rogovin with a surfactant taught by Ogawa, such a replacement would not have been obvious to a person having ordinary skill in the art because “Ogawa neither teaches nor suggests that the glycerin fatty acid esters having an HLB of less than 7 can stabilize a bacterial powder in oil” (Remarks, p. 6, par. 3). Specifically, applicant argues that although the Office Action asserts Ogawa’s relevance to emulsion storage, Ogawa teaches the usefulness in beverages and aqueous products (Ogawa, [0150]). Additionally, applicant asserts that Ogawa clearly discloses an “oil-in-water emulsion” but not oil compositions.
Fourth, applicant asserts that the evidentiary Kanetani reference does not support the rejection because Kanetani discloses solid particles suspended in an aqueous phase containing live bacteria and water in an oily component “and then removing water in the oily component” (Remarks, p. 7, par. 2). Therefore, applicant asserts that because the composition of claim 1 is “clearly different from Kanetani’s product” (Remarks, p. 7, par. 2), Kanetani does not provide relevant evidence to use glycerin fatty acid esters as a surfactant in fatty oil suspensions.
Fifth, applicant asserts that assuming, arguendo, that a person having ordinary skill in the art would find a reason to combine the prior art references, the hypothetical composition and method would still not include each feature claimed. Specifically, applicant argues that even if properly combined, the composition would not exhibit “such a high anti-caking effect” (Remarks, p. 7, par. 4) in which the oil component is present in an amount of at least 90% by mass.
Applicant’s arguments have been fully considered but are not sufficient to overcome the rejection of record for the following reasons.
With respect to the first argument, although the rejection of record involves the substitution of Rogovin’s calcium phosphate with Ogawa’s surfactant, it is not because the Office believes that calcium phosphate is a surfactant. The rejection of record is clear that the simple substitution is made because they perform equivalent functions (stabilizing bacterial powders in oil). This point is made in the rejection of record, in the response to applicant’s arguments presented on p. 6, par. 2 of the Non-Final Rejection, and throughout prosecution.
With respect to the second argument, "[a]ny judgment on obviousness is in a sense necessarily a reconstruction based on hindsight reasoning, but so long as it takes into account only knowledge which was within the level of ordinary skill in the art at the time the claimed invention was made and does not include knowledge gleaned only from applicant’s disclosure, such a reconstruction is proper." (MPEP § 2145(X)(A)). In this case, although applicant’s disclosure was reviewed, the examiner did not take any guidance from applicant’s disclosure to formulate the rejection of record. Rather, the rejection merely relies on the simple substitution of one component of Rogovin’s composition (calcium phosphate) with previously known compositions which perform the same function (a surfactant comprising a glycerin fatty acid ester having an HLB value of less than 7).
With respect to the third argument, Ogawa’s teachings with respect to beverages and aqueous compositions are one component of Ogawa’s disclosure, but that does not mean that Ogawa’s teachings and suggestions are limited to only beverages and aqueous products. It is noted that applicant’s claims are not necessarily an oil composition because they require “90% or more by mass” of the fatty oil. That still allows for oil/water emulsions and because Ogawa clearly teaches that surfactants “can greatly decrease interfacial tension between the oil phase/water phase in the emulsion composition, and as a result, the particle size can be made fine” ([0093]), Ogawa’s surfactants are clearly disclosed as capable of improving storage stability in the same way as the calcium phosphate (i.e., by performing equivalent functions through simple substitution).
With respect to the fourth argument, Kanetani is not necessary to substantiate the underlying obviousness rejection. As discussed previously, Kanetani was provided to rebut applicant’s previous argument that Ogawa neither discloses nor suggests that glycerin fatty acid esters will have the same effect on a composition that includes a high concentration of fatty oils. The applicable teaching here is that Kanetani teaches no restriction or limitation on the content of surfactant in an oil-based composition ([0056]). The oil-based component can be in a range of 0.01-95% by weight and when the surfactant is less than 0.01%, the effect of “suppressing aggregation” between droplets of the oil-in-water emulsions during drying tends to be difficult (Id.). Accordingly, Kanetani demonstrates that glycerin fatty acid esters inherently possess the property to function at high concentrations of oil with viable bacteria.
With respect to the fifth argument, as discussed in the rejection of record, Rogovin in view of Ogawa makes obvious a composition comprising a bacterial powder, a fatty oil, and a surfactant comprising a glycerin fatty acid ester having an HLB value of less than 7. And because the Ogawa directly teaches the use of surfactants to suppress precipitation, it would have been expected to see the anti-caking effect in high concentrations such as the instantly claimed range.
And, as discussed in the previous Office Action, if applicant’s argument that the specific characteristics of the surfactant (i.e., the HLB level) of less than 7 imparts the allegedly unexpected high anti-caking effect (a point which the examiner does not concede), then the evidence of record must be commensurate with the scope of the claims (MPEP § 716.02(d)). The specification only discloses the use of one glycerin fatty acid ester having an HLB value of less than 7 (B-100D; HLB value: 3; [000198], Table 3; [000213], Table 5) with no evidence of record that applicant’s allegedly “high anti-caking effect” would also be observed with any and all glycerin fatty acid esters having an HLB of less than 7. In other words, applicant has not sufficiently demonstrated that the composition necessarily exerts an unexpectedly high anti-caking effect when formulating the composition with any glycerin fatty acid ester having an HLB less than 7 by merely providing an example which uses a single glycerin fatty acid ester surfactant having an HLB of 3.
For at least the above reasons, the rejection of record is deemed proper and has been maintained below.
Maintained rejection under 35 U.S.C. § 103
Claims 1-2, 6, and 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Rogovin et al. (US 2018/0235271 A1; cited previously) in view of Ogawa et al. (US 2008/011515 A1; cited previously), as evidenced by Kanetani et al. (JP 2010168306 A; English Machine Translation).
Regarding claim 1, Rogovin teaches a dietary supplement formulation (i.e., a composition) comprising one or more strains of probiotic microorganisms mixed in an oil with calcium phosphate ([0006]).
With respect to the bacterial powder, Rogovin teaches that probiotic microorganisms include B. longum and B. breve ([0011]) and teaches that the probiotic microorganisms are in a dried powder ([0012]).
With respect to the fatty oil, Rogovin gives exemplary oils such as coconut oil, soybean oil, safflower oil, corn oil, and palm oil ([0013]). These oils are similarly recited as acceptable fatty oils in the scope of the present invention (Specification, [000116]).
With respect to the surfactant comprising a glycerin fatty acid ester having an HLB value of less than 7, Rogovin teaches that calcium phosphate substantially reduces clumping and/or settling of the probiotic powder in oil ([0002]) but does not teach that the surfactant is a glycerin fatty acid ester having an HLB value of less than 7.
Ogawa teaches emulsion compositions including a phospholipid, an oil-based component, and a surfactant ([0016]). Ogawa teaches that surfactants are preferred because surfactant emulsifying agents dissolved in an aqueous medium can greatly decrease interfacial tension between oil phases and water phases ([0093]) and surfactants in appropriate amounts can make the emulsion stability remarkably good ([0116]). Among the exemplary surfactants are polyglycerin fatty acid esters ([0098]) (i.e., glycerin fatty acid esters). Ogawa provides specific examples of glycerin fatty acid esters including a preference for glycerin fatty acid esters such as B-100D ([0102]-[0103]). B-100D has an HLB value of 3 (i.e., falling within the range of less than 7) (Specification, [000257]).
Since Rogovin teaches the use of calcium phosphate to address probiotic formulation stability by substantially reducing the clumping and settling of the probiotic powders in oil ([0005]-[0006]), and because Ogawa teaches glycerin fatty acid esters such as those having an HLB of less than 7 as being useful for emulsifying by greatly decreasing interfacial tension between oil and water phases, it would have been obvious to have substituted the anti-caking agent taught by Rogovin (calcium phosphate) with a surfactant taught by Ogawa (glycerin fatty acid esters having an HLB of less than 7) for the purpose of stabilizing a bacterial powder in oil. The functions of these components were previously known within the art and a person having ordinary skill in the art could have substituted the anti-caking agent taught by Rogovin with a surfactant taught by Ogawa with a predictable result because Ogawa teaches compositions comprising these surfactants for use in addressing the problem of emulsion storage including suppression of disadvantageous precipitation or sedimentation ([0150]). This obviousness is based upon the “Simple Substitution of One Known Element for Another to Obtain Predictable Results” rationale set forth in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007). See MPEP § 2143(I)(B).
With respect to the requirement that that fatty oil is present in the composition in an amount of 90% or more by mass based on the total mass of the composition, as discussed above, Rogovin in view of Ogawa makes obvious a composition comprising a bacterial powder, a fatty oil, and a glycerin fatty acid ester surfactant. Rogovin teaches that the composition should comprise between about 85% to 95% by weight oil and provides a specific example comprising 94% by weight oil ([0016]). This range overlaps with the instantly claimed range and therefore a prima facie case of obviousness exists (MPEP § 2144.05(I)).
Although it is acknowledged that Ogawa teaches an oil:water ratio of 0.1:99.99 to 50:50 ([0142]), this is merely a preferred embodiment and is not considered to teach away from the inclusion of glycerin fatty acid ester in a composition having 90% or more by mass oil. To the contrary, Ogawa teaches that the amount of surfactant is preferably between 2% to 15% by mass and teaches that the amount of surfactant should be low (such as 0.5%) to easily decrease interfacial tension and to prevent heavy foaming ([0119]-[0120]).
Kanetani et al. (hereinafter Kanetani) provides evidence that glycerin fatty acid esters were previously known to function at high concentrations of oil (such as the concentrations taught by Rogovin) by teaching methods for improving storage stability of functional probiotics (such as B. longum and B. breve) including those which are suspended in fats or oils ([0003] and [0024]). Kanetani teaches that viable bacteria are typically dried and covered in oily components to block air and moisture ([0006]) and in production, a surfactant can be added to the oil component as necessary in an amount of 0.01-95% by weight and exemplary surfactants include glycerin fatty acid esters ([0055]-[0058]). Accordingly, Kanetani provides evidence that glycerin fatty acid esters were previously known to function as surfactants in suspensions comprising Bifidobacterial powders in both high- and low-concentration fatty oils.
Thus, claim 1 is obvious over Rogovin in view of Ogawa as evidenced by Kanetani.
Regarding claim 2, Rogovin further teaches that the probiotic microorganisms are “suspended” in a medium-chain triglyceride oil ([0017)], which meets the instant claim’s requirement that the claimed composition is a suspension.
Regarding claim 6, Rogovin teaches embodiments wherein the dietary supplement may comprise 85-95% oil, about 0.1%-14.9% by weight probiotic, and between about 0.1-3% calcium phosphate, and a specific example wherein the probiotic is about 5% by weight ([0016]). Thus, the instantly claimed range falls entirely within the range disclosed by Rogovin (0.1-14.9%). See MPEP § 2131.03.
Regarding claim 8, as discussed above, Rogovin in view of Ogawa makes obvious the composition of claim 1. Rogovin discusses the method of manufacturing the composition and teaches that the ingredients (the probiotic, the oil, calcium phosphate (i.e., the surfactant, as discussed above), and any additional additives or excipients) may be “combined in any order” ([0026]). Thus, it is considered that Rogovin makes obvious the method for producing the composition of claim 1 wherein the ingredients are mixed in an arbitrary order.
Regarding claim 9, as discussed above, Rogovin in view of Ogawa makes obvious the substitution of Rogovin’s calcium phosphate for one of the glycerin fatty acid ester surfactants such as a glycerin fatty acid ester having an HLB value of less than 7, as taught by Ogawa. Rogovin teaches that the purpose of the composition is to reduce the clumping and/or settling of the probiotic powder in the oil (i.e., caking) ([0002]) and teaches that the bacterial powder is added to the oil and calcium phosphate mixture ([0026]). Because the modification is a substitution of calcium phosphate with a surfactant, it is considered that Rogovin makes obvious adding a bacterial powder to a composition comprising a fatty oil and a surfactant.
With respect to the requirement that that fatty oil is present in the composition in an amount of 90% or more by mass based on the total mass of the composition, as discussed above, Rogovin in view of Ogawa makes obvious a composition comprising a bacterial powder, a fatty oil, and a glycerin fatty acid ester surfactant. Rogovin teaches that the composition should comprise between about 85% to 95% by weight oil and provides a specific example comprising 94% by weight oil ([0016]). This range overlaps with the instantly claimed range and therefore a prima facie case of obviousness exists (MPEP § 2144.05(I)). Although it is acknowledged that Ogawa teaches an oil:water ratio of 0.1:99.99 to 50:50 ([0142]), this is merely a preferred embodiment and is not considered to teach away from the inclusion of glycerin fatty acid ester in a composition having 90% or more by mass oil. To the contrary, Ogawa teaches that the amount of surfactant is preferably between 2% to 15% by mass and teaches that the amount of surfactant should be low (such as 0.5%) to easily decrease interfacial tension and to prevent heavy foaming ([0119]-[0120]).
Kanetani provides evidence that glycerin fatty acid esters were previously known to function at high concentrations of oil (such as those concentrations taught by Rogovin) by teaching methods for improving storage stability of functional probiotics (such as B. longum and B. breve) including those which are suspended in fats or oils ([0003] and [0024]). Kanetani teaches that viable bacteria are typically dried and covered in oily components to block air and moisture ([0006]) and in production, a surfactant can be added to the oil component as necessary in an amount of 0.01-95% by weight and exemplary surfactants include glycerin fatty acid esters ([0055]-[0058]). Accordingly, Kanetani provides evidence that glycerin fatty acid esters were previously known to function as surfactants in suspensions comprising Bifidobacterial powders in both high- and low-concentration fatty oils.
Conclusion
No claim is 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 nonprovisional extension fee (37 CFR 1.17(a)) 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GRANT C CURRENS whose telephone number is (571)272-0053. The examiner can normally be reached Monday - Thursday: 7:00-5:00.
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/GRANT C CURRENS/Examiner, Art Unit 1651
/MELENIE L GORDON/Supervisory Patent Examiner, Art Unit 1651