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 .
Election/Restrictions
Applicant's election with traverse of Invention I (claims 1-11) in the reply filed on 04/08/2026 is acknowledged.
The traversal is on the following grounds:
Example 1 of the cited prior art document (Haynes et al.; WO 2021/133177) does not teach yeast in the dough and there is therefore no disclosure of a yeast propagation process;
MPEP § 803 requires a serious search burden and there is not a serious search burden to search and examine all of the claims in the present application.
Applicant’s arguments have been fully considered but are not sufficient to overcome the requirement for Unity of Invention.
With respect to the first argument, yeast is not a component of the special technical feature (see Examiner Graser’s bolded terms in p. 2, par. 6 of the requirement for unity of invention). The linking feature of the claimed inventions is a composition comprising lecithin and a molasses substance. The previous examiner appropriately identified the linking feature and presented evidence that this linking feature is not a special technical feature.
With respect to the second argument, the consideration of serious search burden is relevant to applications filed under § 121. The requirement for Unity of Invention is made without respect to search burden (See MPEP § 1893.03(d)).
The requirement is still deemed proper and is therefore made FINAL.
Claims 12-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 1-11 are directed to the elected invention and have been examined on the merits.
Priority
The present application is a § 371 National Stage entry of PCT/US2022/079159 (filed on 11/02/2022), which claims benefit of U.S. provisional application 63/278,908 (filed on 11/12/2021).
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/05/2024 is in compliance with the provisions of 37 C.F.R. 1.97. All references cited in this IDS have been fully considered.
Claim Objections
Claims 2-11 are objected to because the word “claim” should not be capitalized.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation 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 1-11 are rejected under 35 U.S.C. 112(a) because the specification, while being enabling for reducing melanoidin formation with some amounts of lecithin, does not reasonably provide enablement for inhibiting melanoidin formation and with all amounts of lecithin.
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The Wands Factors
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.
Analysis
With respect to the breadth of the claims and the nature of the invention, applicant’s invention is directed to a method of inhibiting melanoidin in a yeast propagation process.
The term “inhibiting” has not been specially defined and is interpreted in its broadest reasonable form to include absolute reduction in melanoidin formation. The term “yeast propagation process” has not been specially defined and includes any process which involves the growth of yeast. The specific steps involved in the generic claim encompasses “adding a treatment composition to a molasses substance present in a yeast propagation process”. The “treatment composition” comprises “a lecithin”.
Claim 2 limits the “lecithin” to comprise a soy lecithin, a non-soy lecithin, a sunflower lecithin, an egg yolk lecithin, or combination thereof. Because this claim allows for the lecithin to be soy or non-soy, it encompasses every lecithin and does not limit claim 1.
Claim 3 requires the composition to further comprise a surfactant.
Claim 4 limits the source of the molasses.
Claim 5 requires the “yeast propagation process” to comprise the formation of melanoidin compounds.
Claim 6 requires the yeast propagation process to comprise a molasses sterilization step.
Claim 7 requires the yeast propagation process to comprise a yeast fermentation step.
Claim 8 requires the treatment composition to be added to the molasses substance prior to the molasses sterilization step.
Claim 9 requires the treatment composition to inhibit the formation of melanoidin compounds present during the sterilization step.
Claims 10-11 limits the amount of treatment composition.
With respect to the state of the prior art, the prior art teaches away from the claimed invention by teaching the following.
Davies et al. (University of Minnesota, Department of Food Science and Nutrition, 2000, pages 1-33) teaches that the Maillard reaction is a nonenzymatic browning reaction which occurs between reducing sugars and carbohydrates or amine groups (p. 3, par. 3). Sugars include sources such as dextrose, fructose, high fructose corn syrup, sucrose, corn starch, and maltodextrin and protein sources include inter alia lecithin (Id.). Fig. 1 demonstrates this reaction resulting in the production of melanoidins. Davies teaches that the end stage of the Maillard reaction is the formation of a heterogenous mixture of melanoidins by the polymerization of highly reactive intermediates and this formation results in the formation of a brown color (p. 5, par. 5 through p. 6, par. 4). Davies teaches that the course of the Maillard reaction is “strongly affected by factors which influence the different chemical reactions involved” and among these factors is reactant type (p. 13, par. 2).
Liakos et al. (Journal of Water Process Engineering, 2016, Vol. 10, pages 156-164) teaches that melanoidins are high molecular weight compounds which are formed in the last stage of the Maillard reaction (p. 156, left col., par. 1). Melanoidins have commercial, nutritional, and toxicological significance because they have considerable effect on the quality of food (Id.). Removal of melanoidins and their recovery is very important both for ecological reasons and for commercial use (p. 156, right col., par. 1). Techniques for removing melanoidin include adsorption, coagulation, UV/H2O2 oxidation, electrochemical methods, ozonation, membrane treatment, and evaporation (Id.). Liakos is chiefly concerned with the removal of melanoidins resulting from the use of molasses (abstract; p. 156, left col., par. 2) in conjunction with a baker’s yeast manufacturing factory (p. 157, left col., par. 1). Liakos does not teach the addition of lecithin to molasses for inhibiting melanoidin production.
Collins et al. (US 2013/0236601 A1) similarly teaches that acrylamide is formed from the presence of amino acids and reducing sugars and it is believed that acrylamide formation involves a Maillard reaction ([0015]-[0017]). Collins teaches that the Maillard reaction involves a series of complex reactions ending in the formation of brown nitrogenous polymers and co-polymers ([0018]). Collins teaches that acrylamide can be added to molasses after its production to efficiently and effectively reduce the amount of acrylamide formed during later heat treatment ([0019]). Although Collins teaches the addition of an active component (acrylamide reducing agents) to molasses, it does not teach the addition of lecithin for this purpose.
Klein et al. (US 2007/0277814 A1) teaches lecithinated sugar compositions wherein lecithin is present in the sugar composition at not more than about 200 parts per million (abstract). Specifically, Klein teaches such compositions for increasing the yield of raw or refined sugar ([0044]). Klein teaches that the liquid streams can contain yeasts ([0049]) and Klein’s working examples involve the use of molasses (see, for example, [0067]). Accordingly, Klein teaches the addition of lecithin to molasses. And although Klein acknowledges adding a component such as trace sulfur dioxide in order to catalytically inhibit the Maillard or browning reaction ([0013]), Klein does not teach or suggest that lecithin is added for such a purpose. In fact, a person having ordinary skill in the art would have interpreted Klein’s disclosure as implying that lecithin is not suitable for inhibiting this process because the sulfur dioxide is added in addition to lecithin in order to prevent browning.
Accordingly, the prior art as a whole does not teach adding a treatment composition comprising a lecithin and some references (such as Davies and Klein) suggest that lecithin is a contributor to, not an inhibitor of the melanoidin formation process.
With respect to the amount of guidance provided by applicant and the existence of working examples, applicant has provided a working example wherein lecithin is added to molasses prior to sterilization in order to reduce formation of dark coloration of yeast ([0035]). Specifically, applicant’s working example involves treating molasses with a “lecithin-based composition” at various concentrations, the molasses samples were then sterilized and added to yeast samples (Id.). After centrifugation, the yeast solids were evaluated and rated on a comparative visual scale (Id.).
Applicant’s working example involves diluting the sample to concentrations that consisted of 50% dissolved solids with a sugar content of 42 degrees brix and prior to treatment with 0, 100, 200, and 400 ppm of a lecithin containing composition. Then, the samples were sterilized at 120°C for 3 hours, cooled for 2 hours, inoculated to yeast, fermented for 24 hours, and the resulting yeast were recovered by centrifugation ([0036]; Table 1). Applicant reports subjectively that 0 ppm lecithin resulted in “poor, dominated by dark color” coloration, 100 ppm lecithin resulted in “moderate, approximately the same amount of dark and light color”, and 200 ppm and 400 ppm resulted in “very good, very little dark color” (Tables 2 and 3; [0037]-[0038]).
With respect to the level of one of ordinary skill, a person having ordinary skill in the art is a person having an advanced understanding of microbiology.
With respect to the quantity of experimentation and the level of predictability, as discussed above, the prior art does not teach or suggest that lecithin can be added to molasses in order to inhibit melanoidin formation in a yeast propagation process. To the contrary, the prior art suggests that lecithin is actually a contributor to melanoidin generation, especially when combined with a sugar such as molasses. Accordingly, a person having ordinary skill in the art could look only to applicant’s working example in order to enable the claimed invention. Applicant’s working example demonstrates that melanoidin formation may be reduced with some amounts of lecithin (as shown by the subjective visual evaluation in Table 3). However, there is an undue amount of experimentation needed to enable the claim over its entire scope for the following reasons:
1) The plain meaning of “inhibiting melanoidin formation” includes complete reduction in melanoidin formation. Applicant has not provided any working examples demonstrating that melanoidin formation could be completely reduced (i.e., has only subjectively demonstrated reducing the formation of melanoidin).
2) The claims allow for any amount of lecithin addition including from as low as 1 ppm (or “about 1 ppm”) to an uncapped amount of lecithin. Applicant’s narrowest claim (claim 11) limits the upper limit to “about 500 ppm”, which is 100 ppm higher than the upper limit tested in the working examples. Similarly, applicant’s narrowest claim limits the lower limit to “about 25 ppm”, which is lower than the lowest concentration lecithin-containing composition.
3) The claims limiting the amount of “treatment composition” (claims 10-11) are not limiting of the amount of lecithin per se but are instead limiting to the amount of “treatment composition”. The “treatment composition” is open to unrecited components by virtue of the “comprising” language of claim 1 and therefore a treatment composition may have minute/trace amounts of lecithin and instead have other components totaling, for example, “about 1 ppm”.
4) The claims allow for addition of lecithin at any stage of a generic “yeast propagation process” while Applicant’s working examples involve addition prior to sterilization. The sterilization step is identified as the step which causes the production of melanoidin compounds ([0004]-[0005]). Accordingly, there is low expectation that melanoidin production can be inhibited when the lecithin is added at a time after melanoidin would have been expected to be produced.
Accordingly, applicant has demonstrated reduction in melanoidin production in a narrow embodiment of the claimed invention but a person having ordinary skill in the art, especially with knowledge that lecithin contributes to melanoidin production, would not be able to use the invention over its entire breadth with a high expectation of success. Specifically, a person having ordinary skill in the art would be required to perform an undue amount of experimentation when performing the method with any other subset of reaction conditions not outlined in the specification because the prior art suggests that an opposite effect would be expected to occur.
Conclusion
Upon consideration of each of the Wands factors and the evidence as a whole, applicant has demonstrated reduction in melanoidin production in a yeast propagation process when lecithin is added to molasses in the amount of 100-400 ppm prior to a molasses sterilization step but has not demonstrated, without undue experimentation, the broader claim to inhibiting melanoidin production through addition of any amount of lecithin to molasses at any step of a generic yeast propagation process.
Claims 5 and 10-11 are 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 5 is rejected as indefinite because it requires the “yeast propagation process” to comprise “the formation of melanoidin compounds”. This claim is unclear because, as discussed above, the independent claim is to a method of “inhibiting melanoidin formation” and the broadest reasonable interpretation of the term “inhibiting” includes absolute reduction in melanoidin formation. Accordingly, it is not clear how the method could “inhibit melanoidin formation” and also comprise a step of “formation of melanoidin compounds”.
Claims 10-11 are rejected as indefinite because they recite the approximations “about 1 ppm to about 1000 ppm” (claim 10) and “about 25 ppm to about 500 ppm” (claim 11).
In determining the range encompassed by the term "about," one must consider the context of the term as it is used in the specification and claims of the application (MPEP § 2173.05(b)(III)(A)). Applicant’s disclosure has been fully considered but does not provide sufficient guidance such that a person having ordinary skill in the art would be apprised of what applicant means by the approximation “about”. The specification provides working examples including the use of 0, 100, 200, or 400 ppm but there is no indication what approximations are related to these specific amounts nor is there any guidance as to what is meant by “about”. For example, is “400 ppm” considered to be “about 500 ppm”? Or is there some other definite range of values encompassed by the ranges defined by the approximation “about”? Because this is unclear, the metes and bounds of the claimed invention are not clearly defined and the claim is indefinite.
For the purpose of considering enablement (above) and prior art, the claims have not been considered for the approximation “about” because it is not possible to ascertain what this approximation actually encompasses.
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 “lecithin” of claim 1 to be either a soy lecithin, a non-soy lecithin, a sunflower lecithin, an egg yolk lecithin, or a combination thereof. The terms “soy lecithin” and “non-soy lecithin” encompass the entire genus of “lecithin” (i.e., a lecithin must be either soy or non-soy). Accordingly, the scope of lecithin covered by claim 1 is the same as the scope of the lecithin covered by claim 2 and the claim is not further limiting to the claim upon which it depends.
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.
Conclusion
No claim is allowed.
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/GRANT C CURRENS/Examiner, Art Unit 1651
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