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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/18/2026 has been entered.
Amendments
Claims 1 and 9 now require the HLB to be less than 3 and requires the composition to be an oil-continuous suspension.
Claim 8 now requires that the HLB is less than 3.
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.
(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.
(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.
Claims 1-2, 6, and 8-9 are rejected under 35 U.S.C. 112(a) 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 inventor or a joint inventor had possession of the claimed invention.
Applicant’s amended claims are directed to compositions and methods of using or preparing compositions comprising a bacterial powder, a fatty oil, and a surfactant.
The surfactant has been limited to a glycerin fatty acid ester having an HLB value of less than 3.
Applicant’s working examples involve the following:
First, applicant describes the preparation of a bacterial powders of B. infantis, B. breve, B. longum subsp. longum, L. gasseri, L. acidophilus, L. paracasei, L. helveticus, and B. longum subsp. infantis.
Second, applicant tested the dispersibility of compositions comprising bacterial powder 1 (Bifidobacterium infantis), S9013 (fatty oil), and one of: microcrystalline cellulose, fine silicon dioxide, calcium stearate, B-100D, S-170, S-770, and S-1570.
Third, applicant tested the dispersibility of compositions comprising bacterial powder 1 (Bifidobacterium infantis), S9013 (fatty oil), and one of: tricalcium phosphate, magnesium stearate, P-170, O-170, L-195, B-370F, ER-190, and POS-135.
Fourth, applicant tested the dispersibility of compositions comprising bacterial powder 2 (Bifidobacterium breve), S9013 (fatty oil), and one of: tricalcium phosphate, calcium stearate, magnesium stearate, B-100D, S-170, P-170, and B-370F.
Fifth, applicant tested the dispersibility of composition comprising S9013, and one of: bacterial powder 3, 4, 5, 6, 7, or 8, with or without calcium stearate.
Sixth, applicant tested the dispersibility of compositions consisting of bacterial powder 9, calcium stearate, and S9013.
Of the surfactants used, S-170, P-170, O-170, L-195, B-370F, ER-190, POS-135, S-770, and S-1570 are sucrose fatty acid esters having varying HLBs of 1-16 ([000258]-[000266]). In contrast, the only glycerin fatty acid ester tested by applicant is B-100D, which is a surfactant having an HLB of 3 ([000257]).
Accordingly, none of the working examples involve a glycerin fatty acid ester having an HLB value of less than 3, as required by the amended claim.
Prophetically, applicant’s disclosure discusses compositions comprising glycerin fatty acid esters having an HLB value of less than 7 ([000137]). The specification also provides that the glycerin fatty acid ester preferably has a value of from 5 to less than 7 (Id.).
Possession may be shown in many ways. For example, possession may be shown by describing an actual reduction to practice of the claimed invention. Possession may also be shown by a clear depiction of the invention in detailed drawings or in structural chemical formulas which permit a person skilled in the art to clearly recognize that inventor had possession of the claimed invention. An adequate written description of the invention may be shown by any description of sufficient, relevant, identifying characteristics so long as a person skilled in the art would recognize that the inventor had possession of the claimed invention (MPEP § 2163(II)(A)(3)(a)).
Applicant has convincingly argued that a person having ordinary skill in the art would not envision using such low HLB compositions (e.g., less than 3) in combination with a bacterial powder and fatty oil. Zheng et al. (Polar Lipids: Biology, Chemistry, and Technology, Chapter 8, Sugar Fatty Acid Esters. Elsevier. 2015, pages 215-243) teaches that hydrophilic-lipophilic balance (HLB) is the balance of the size and strength of hydrophilic and lipophilic moieties of a surfactant molecule and in the range of 3.5 to 6.0, surfactants are more suitable for use in W/O emulsions (p. 216, par. 3). The art does not teach or suggest the use of surfactants having an HLB of less than 3 for the purpose of use in W/O emulsions or continuous suspensions.
Accordingly, the next relevant question is whether applicant has demonstrated possession by description of sufficient, relevant, identifying characteristics. As shown by applicant’s working examples (and replicated below), HLB values do not necessarily correspond to a specific level of dispersibility.
HLB 1 (S-170D [C], P-170 [B], O-170 [B], L-195[C], ER-190[C], POS-135[A])
HLB 3 (B-100D [A], B-370F[A])
HLB 7 (S-770 [D])
HLB 16 (S-1570 [D])
When considering all of the disclosed surfactants which have an HLB of “less than 3” (none of which are glycerin fatty acid esters), there is clear variability in results with only 1 of the 6 tested surfactants preventing settling.
Upon consideration of each of these factors, applicant has not reasonably conveyed to one skilled in the relevant art that the inventor or a joint inventor had possession of the invention now required by the amended claims (i.e., a composition comprising a bacterial powder, a fatty oil, and a surfactant having the recited characteristics) because although the original disclosure alludes to glycerin fatty acid esters, the disclosure does not provide sufficient, relevant, identifying characteristics which would demonstrate that applicant was in possession of the specific composition (and methods) recited in the amended claims.
Claim 9 is rejected under 35 U.S.C. 112(a) as failing to comply with the enablement requirement.
The claim contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The factors considered when determining if there is sufficient evidence to support that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue” include, but are not limited to: (A) The breadth of the claims; (B) The nature of the invention; (C) The state of the prior art; (D) The level of one of ordinary skill; (E) The level of predictability in the art; (F) The amount of direction provided by the inventor; (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure. See In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988). MPEP § 2164.04
further states that although the analysis and conclusion of a lack of enablement are based on these factors and the evidence as a whole, it is not necessary to discuss each factor in the enablement rejection.
With respect to the breadth of the claims and the nature of the invention, claim 9 is directed to a method of preventing caking in a composition. There is no special definition for the term “preventing”, which has been interpreted in its broadest reasonable form to require complete reduction of the formation of caking. The method involves adding a bacterial powder to a comprising a fatty oil and a surfactant. The surfactant is limited to a glycerin fatty acid ester having an HLB value of less than 3. The bacterial powder is selected from the group consisting of live cells of Bifidobacteria, killed cells of Bifidobacteria, and combinations thereof. The Bifidobacteria are selected from B. longum, B. breve, and combinations thereof. The fatty oil is required to be in an amount of 90% of more by mass based on the total mass of the composition.
With respect to the level of one of ordinary skill, a person having ordinary skill is a person having an understanding of pharmaceutical formulations or microbiology.
With respect to the state of the prior art, the closest prior art is Rogovin et al. (US 2018/0235271 A1; cited previously), which teaches dietary supplement formulations comprising probiotic microorganisms mixed in oil with calcium phosphate ([0006]). Rogovin teaches that the calcium phosphate can address probiotic formulation stability by substantially reducing clumping and settling of probiotic powders in oil ([0005]-[0006]) but does not teach or suggest the use of glycerin fatty acid esters having an HLB of less than 3.
Moreover, Kanetani et al. (JP 2010168306 A; English Machine Translation; hereinafter Kanetani) teaches 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]).
And although Kanetani teaches that the surfactant should be an HLB of 10 or less ([0057]), a person having ordinary skill in the art would not consider this to include surfactants having an HLB of 3 or less. Zheng et al. (Polar Lipids: Biology, Chemistry, and Technology, Chapter 8, Sugar Fatty Acid Esters. Elsevier. 2015, pages 215-243) teaches that hydrophilic-lipophilic balance (HLB) is the balance of the size and strength of hydrophilic and lipophilic moieties of a surfactant molecule and in the range of 3.5 to 6.0, surfactants are more suitable for use in W/O emulsions (p. 216, par. 3).
With respect to the amount of direction provided by the inventor and the existence of working examples, Applicant’s working examples involve the following:
First, applicant describes the preparation of a bacterial powders of B. infantis, B. breve, B. longum subsp. longum, L. gasseri, L. acidophilus, L. paracasei, L. helveticus, and B. longum subsp. infantis.
Second, applicant tested the dispersibility of compositions comprising bacterial powder 1 (Bifidobacterium infantis), S9013 (fatty oil), and one of: microcrystalline cellulose, fine silicon dioxide, calcium stearate, B-100D, S-170, S-770, and S-1570.
Third, applicant tested the dispersibility of compositions comprising bacterial powder 1 (Bifidobacterium infantis), S9013 (fatty oil), and one of: tricalcium phosphate, magnesium stearate, P-170, O-170, L-195, B-370F, ER-190, and POS-135.
Fourth, applicant tested the dispersibility of compositions comprising bacterial powder 2 (Bifidobacterium breve), S9013 (fatty oil), and one of: tricalcium phosphate, calcium stearate, magnesium stearate, B-100D, S-170, P-170, and B-370F.
Fifth, applicant tested the dispersibility of composition comprising S9013, and one of: bacterial powder 3, 4, 5, 6, 7, or 8, with or without calcium stearate.
Sixth, applicant tested the dispersibility of compositions consisting of bacterial powder 9, calcium stearate, and S9013.
Of the surfactants used, S-170, P-170, O-170, L-195, B-370F, ER-190, POS-135, S-770, and S-1570 are sucrose fatty acid esters having varying HLBs of 1-16 ([000258]-[000266]). In contrast, the only glycerin fatty acid ester tested by applicant is B-100D, which is a surfactant having an HLB of 3 ([000257]). As shown by applicant’s working examples (and replicated below), HLB values do not necessarily correspond to a specific level of dispersibility.
HLB 1 (S-170D [C], P-170 [B], O-170 [B], L-195[C], ER-190[C], POS-135[A])
HLB 3 (B-100D [A], B-370F[A])
HLB 7 (S-770 [D])
HLB 16 (S-1570 [D])
Accordingly, none of the working examples involve a glycerin fatty acid ester having an HLB value of less than 3, as required by the amended claim and to the extent that applicant has tested HLB values of less than 3, there is clear variability in the ability of surfactants to prevent caking.
With respect to the level of predictability and the quantity of experimentation, as discussed above, the prior art does not teach or suggest the use of surfactants having an HLB of less than 3 as required by the claim. Accordingly, a person having ordinary skill in the art could look only to applicant’s working examples to enable the invention. As discussed above, applicant has not provided any working examples demonstrating prevention of caking with glycerin fatty acid ester surfactants having an HLB of less than 3 and to the extent that applicant has tested HLBs of less than 3, there is clear variability in results, leading to a low level of predictability that a glycerin fatty acid ester having an HLB of less than 3 could achieve prevention of caking. Moreover, applicant’s working example demonstrate that the anti-caking effect is surfactant specific (see, for example, the varying results of sucrose fatty acid esters having HLB of 1). Accordingly, there is a high level of experimentation needed to determine which, if any, surfactants covered by the breath of the claim actually achieve prevention.
Conclusion
Upon consideration of the Wands factors and the evidence as a whole, applicant’s claim to a method of preventing caking fully lacks enablement.
Claim 6 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, regards as the invention.
Claim 6 limits the amount of bacterial powder in the composition to be 0.5 to 10 mass % based on the total mass of the composition. Claim 1 (the claim from which this claim depends) requires the fatty oil to be “in an amount of 90% or more by mass”. As such, it is unclear how the bacterial powder could be in the composition in an amount of 10% by mass. For example, if the composition is 10% bacterial powder, and 90% fatty oil, the composition could not also comprise the surfactant.
Claim 2 is rejected under 35 U.S.C. 112(d) 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.
Claim 2 limits the composition to be a suspension. Claim 1, as amended, now requires an oil-continuous suspension. Accordingly, because the composition is already required to be a suspension, claim 2 is not further limiting.
Applicant may cancel the claim, amend the claim to place the claim in proper dependent form, rewrite the claim in independent form, or present a sufficient showing that the dependent claim complies with the statutory requirements.
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 rejections 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 has amended claims 1-2, 6, and 8-9 such that the surfactant must be a glycerin fatty acid ester having an HLB value of less than 3. Ogawa was previously considered to remedy the deficiencies of Rogovin by teaching surfactants such as B-100D can be used to improve emulsion stability. Accordingly, the rejection of record sets forth a prima facie case of obviousness for simply substituting Rogovin’s calcium phosphate with a surfactant such as B-100D (having an HLB of 3). There is, however, no teaching or suggestion to use glycerin fatty acid esters having an HLB of less than 3 for preventing caking. As such, there is no teaching or suggestion to arrive at the instant compositions or methods and the rejection under 35 U.S.C. § 103 has been withdrawn.
Conclusion
No claim is allowed.
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/GRANT C CURRENS/Examiner, Art Unit 1651
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