DETAILED ACTION
Background
The amendment dated September 17, 2025 (amendment) amending claim 20 has been entered. Claims 20, 22-23, 25 and 27-32 as filed with the amendment have been examined. Claims 1-19, 21, 24 and 26 have been canceled.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined.
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 the first paragraph of pre-AIA 35 U.S.C. 112:
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 20, 22-23, 25 and 27-32 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 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Specifically, the inventors did not have possession of the feature recited in claim 20, at line 8, as a “plant nut milk that is neither emulsified nor thickened” because the specification does not disclose a plant nut milk wherein thickening by any means is entirely excluded, especially as the Example 1 at [0034] of the instant specification discloses keeping the milk at 50°C for 5 hours in deamidating which would be expected to evaporate a significant amount of the water or aqueous phase in the milk; further, the same example refers to a commercial product (Rude Health almond milk) which appears to be an emulsion. This is evidenced in US 2022/0079187 A1 to Stiles et al. (Stiles) at [0114] disclosing that compositions defining a plant milk have droplet sizes of from 1 to 100 nm and are metastable; a description that characterizes an emulsion. The Office considers an emulsion as claimed to include any milk. The instant specification fails to draw any distinction that in any way defines or discloses a milk that is not emulsified.
Claims 22-23, 25 and 27-32 are rejected as depending from a rejected base claim.
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 20, 22-23, 25 and 27-32 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In claim 20, at line 8, the term a “plant nut milk that is neither emulsified” is indefinite because it is not clear what is meant by a plant nut milk that is not emulsified. The product of Example 1 at [0034] of the instant specification starts from a Rude Health almond milk which appears to be a metastable emulsion as disclosed at [0114] of Stiles as having uniform droplets of almond oil or fat in sizes of from 1 to 100 nm and dispersed in water or an aqueous phase. Also, the homogeneous appearance of the Rude Health almond milk suggests that the plant nut milk has been homogenized which would mechanically emulsify it as disclosed in Stiles at [0113].
Claims 22-23, 25 and 27-32 are rejected as depending from a rejected base claim.
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.
Claims 20, 22-23, 25 and 27-32 are rejected under 35 U.S.C. 103 as being unpatentable over US patent application publication number US 2022/0079187 A1 to Stiles et al. (Stiles), of record.
Regarding instant claims 20, 23, 25 and 32, Stiles at Example 2 and [0175]-[0176] discloses a method of preparing (“providing”) a non-dairy analogue (“plant milk”) having 3 wt% protein (claim 23) and mixing it with a coffee (claim 25) beverage (“liquid beverage or food”) having a pH of about 5.15 and heated to a temperature of 65 to 70 °C to obtain a mixture without aggregation of proteins in the plant milk, wherein the obtained mixture contains 2 g of plant protein. Stiles at [0173] discloses treating the plant protein in the plant milk with a protein deamidase at 45-50 °C; and, at Example 4 at [0180]-[0182] and the accompanying Table, Stiles discloses formulating the plant milk with the protein and homogenizing it to provide the plant milk at a pH of 8.3 comprising the protein, water, sunflower oil, potassium hydroxide, sugar and from 0.01 to 0.05 wt% gum. See Figure 1 and Table 2 of Stiles showing no aggregation or feathering upon the mixing of the plant milk with coffee. The plant milk of Example 4 of Stiles includes no emulsifier.
The Office considers an emulsifier as a molecule comprising both hydrophilic and hydrophobic groups, such as a diglyceride or lecithin. And the Office considers gums to be polysaccharides which lack a hydrophobic group and are considered as thickeners.
Further regarding instant claim 20, the Office considers the claimed mixture having a pH of from 5 to 7 to include the mixture containing 2g protein made from the plant milk of Example 4 of Stiles (protein content 3 wt%, pH 8.3 or pOH (14 minus 8.3 or) pOH 5.7, [OH-]= 10-5.7 M) and from the coffee in Example 2 of Stiles (pH 5.15, [H+] = 10--5.15 M) as in Stiles at [0175]. To give a mixture with 2 g protein, the mixture comprises 100 ml of the coffee (pH 5.15, total moles H+ of 10--5.15 M X 0.1 L or 7.08 X 10-7 mol) and 200 ml of the plant milk (pH 8.3, total moles OH- of 10--5.7 M X 0.2 L or 3.98 X 10--7 mol). The mixture comprises 7.08 X 10-7 mol H+ minus 3.98 X 10-7 mol OH- or 3.10 X 10-7 mol excess moles H+ in a total volume of 0.3 L, to give an [H+] of 1.03 X 10-6 mol. This molarity of H+, in turn corresponds to a pH or -log10[H+] or -log10[1.03 X 10-6 mol] or a pH for the mixture of Stiles of 5.98.
Further still regarding instant claims 20 and 32, Stiles does not disclose an example of deamidating a plant nut milk. However, at [0041] Stiles discloses that suitable nondairy analogues or plant milks comprise milks from hazelnut, almond or peanut. Before the effective filing date of the present invention, the ordinary skilled artisan would have found it obvious in view of Stiles to deamidate any of the hazelnut, almond, peanut or macadamia plant nut milks as suitable deamidation substrates in Stiles to make them more dispersible or soluble in water as in Stiles at [0076].
Yet further regarding instant claim 20, Stiles does not disclose an example of a plant nut milk comprising no polysaccharide thickener for preventing aggregation; and does not give an example of a plant nut milk that is neither emulsified nor thickened. However, at [0023] Stiles discloses generally deamidated plant protein in water without disclosing therein any additives; and, further at [0111] Stiles discloses thickening agents as optional, thereby including plant milk with no polysaccharide thickener.
The plant nut milk of Stiles appears to be substantially the same thing as the plant nut milk as deamidated almond milk in the Example 1 at [0034] of the instant specification. Accordingly, absent a clear showing as to how the plant nut milk Stiles differs from the claimed plant nut milk, the Office considers to be a plant nut milk of Stiles at [0041], [0023] and [0111] that is neither emulsified nor thickened as in claim 20. See MPEP 2112.01.I.
Before the effective filing date of the present invention, the ordinary skilled artisan would have found it obvious in view of Stiles to make its protein containing plant nut milk without any emulsifier or polysaccharide thickener by making its plant nut milk using high pressure homogenizing and pH adjustment to a pH wherein the protein in the aqueous phase or the amide groups on the protein are soluble. The ordinary skilled artisan in Stiles would have desired to make its plant nut milk stable without including in it a thickening polysaccharide as in by high pressure homogenizing the milk or by optimizing the pH of the plant nut milk to solubilize the deamidated protein and/or its amide groups. In addition, the ordinary skilled artisan in Stiles would have desired to make its deamidated proteins more water soluble without the use of a thickening polysaccharide by salting them with cations such as potassium or sodium by using alkali to adjust the pH of the milk containing proteins having amide groups during dispersion.
Regarding instant claims 27–28, the enzyme used in Example 2 of Stiles is a Amano PG 500 deamidase (see [0173]) which is believed to be derived from Chryseobacterium proteolyticum or at least to be the same deamidase as that derived from Chryseobacterium proteolyticum. Further, Stiles discloses a Chryseobacterium proteolyticum deamidase at [0049]. Absent a clear showing as to how the Example 2 deamidase of Stiles differs from that of the Chryseobacterium proteolyticum deamidase, as claimed, the Office considers the Amano PG 500 deamidase of Example 2 of Stiles to be a Chryseobacterium proteolyticum deamidase. See MPEP 2112.01.I.
Regarding instant claims 29-31, Stiles at [0055] discloses a method of mixing a deamidated nondairy analog of nut milk (at [0041]) with a hot aqueous composition (at Example 2 a coffee) wherein the deamidase treated plant nut milk has not been heat treated previously with a protein deamidase. Further, at [0099] Stiles discloses a method for preparing a non-dairy analog beverage comprising (at [0100] – [0101]) treating the non-dairy analog as an unmodified substrate comprising a sterilized or protein deamidase, followed by (at [0103]) heat treating the non-dairy analog beverage.
Response to Arguments
The positions taken in the remarks accompanying the amendment dated September 17, 2025 (Reply) have been fully considered but they are not found persuasive for the following reasons:
Regarding the positions taken in the Reply at page 4 that the claimed plant nut milk is neither emulsified nor thickened, these points are addressed in the new grounds of rejection citing Stiles at [0111] (no thickener) and the fact that the plant nut milk of Stiles at [0041], [0023] and [0111] prior to being deamidated appears to be the same thing as the Example 1 Rude Health almond milk at [0034] of the instant specification. Respectfully, the almond milk in Example 1 of the instant specification appears to be the same thing as the plant milk disclosed at [0114] of Stiles as having uniform droplets of almond oil or fat in sizes of from 1 to 100 nm and dispersed in water or an aqueous phase. See MPEP 2112.01.I.
The position taken in the Reply at page 4 alleges that emulsification in Stiles requires an emulsifier. However, the plant milk of Example 1 of Stiles as shown in Table 3 and in Example 4 does not include any emulsifier.
Regarding the positions taken in the Reply at pages 4-5 detailing emulsifying methods and alleging that there is no motivation in Stiles for the ordinary skilled artisan to use a plant milk that does not contain emulsifier or polysaccharide thickener, the positions taken simply do not address the fact that the plant milk made in Example 4 of Stiles does not include any emulsifier, and the fact that Stiles at [0111] discloses thickeners as optional.
Regarding the position taken in the Reply at pages 5-6 that the object and intended purpose of Stiles is to produce an emulsified plant milk, respectfully the plant nut milk as claimed and that of Stiles at [0041], [0023] and [0111] appear based on all the evidence on the record to be substantially the same thing. The Reply provides no clear showing as to how the claimed plant nut milk differs from that of Stiles.
Regarding the position taken in the Reply at page 6 that Stiles provides an example of a pea milk, respectfully it is for this reason why the rejection cites 35 USC section 103 and is an obviousness rejection. The ordinary skilled artisan in Stiles at [0041] would have found it obvious to deamidate a plant nut milk because Stiles discloses that plant nut milks are a desirable substrate for deamidation. In view of this, the burden remains on Applicant to provide a showing of unobviousness. However, a showing of unexpected results must be based on evidence, not argument or speculation. In re Mayne, 104 F.3d 1339, 1343-44, 41 USPQ2d 1451, 1455-56 (Fed. Cir. 1997). Any such comparative evidence would have to be based on an apples to apples comparison.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 ANDREW E MERRIAM whose telephone number is (571)272-0082. The examiner can normally be reached M-H 8:00A-5:30P and alternate Fridays 8:30A-5P.
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/ANDREW E MERRIAM/ Examiner, Art Unit 1791
/Nikki H. Dees/ Supervisory Patent Examiner, Art Unit 1791