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 .
DETAILED ACTION
Claims 1-12 are pending.
Domestic Benefit and Foreign Priority
Applicant’s claim for priority to the filing date of EP19167044.7 filed 03 April 2019 and PCT/EP2020/059126 filed 31 March 2020, and to the domestic benefit of parent application no. 17/601,316 filed 04 October 2021 is acknowledged. Receipt is also acknowledged of certified copies of papers required by 37 CFR 1.55.
The effective filing date is 03 April 2019.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 21 February 2025 is being considered by the examiner.
Claim Objections
Claims 1-12 are objected to because of the following informalities:
The word “item” in the “food item” preamble of claims 1-12 is extraneous and should be deleted.
The extraneous comma between “fermentation” and “by” on line 3 of claim 1 should be deleted.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 1-12 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.
Regarding claim 1, it is unclear if: (1) the first and second fermentations are performed sequentially such that the product of the first fermentation with Lactobacillus rhamnosus is then subjected to a subsequent fermentation with Lactobacillus gasseri and Bifidobacterium breve; or (2) the two fermentations are performed in parallel to each other, such that they are two separate fermentations of identical plant substrates, but fermented with different microorganisms. It is uncertain whether the claimed product requires a fermented plant with or without Lactobacillus rhamnosus, Lactobacillus gasseri and Bifidobacterium breve.
Regarding claim 10, it is unclear whether the plant substrate is combined with the donkey or sheep milk (1) prior to, or (2) after, performing the second fermentation with Lactobacillus gasseri and Bifidobacterium breve of claim 1.
Regarding claim 12, the claim term “formula” renders the claim indefinite because it is not clear if the food item is being limited to (1) an infant formula (a substitute for human breast milk); or (2) any food with a “formula”, which is defined as a list of ingredients for, or constituents of, a food. The specification does not define this term, either.
Claims 2-12 are dependent on claim 1, so are indefinite for the same reason.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to the judicial exception of a product of nature without significantly more.
Claims 1-12 are drawn to the statutory category of a composition of matter (Step 1: Yes).
Claims 1-4 recite a food item comprising a fermented product obtained by a first of a plant substrate with Lactobacillus rhamnosus and a second fermentation of the plant substrate with Lactobacillus gasseri and Bifidobacterium breve. Fermentation is a naturally occurring process where a microorganism (such as Lactobacillus rhamnosus, Lactobacillus gasseri, and Bifidobacterium breve) biochemically break down and metabolize organic matter (such as a plant substrate). The microorganisms Lactobacillus rhamnosus, Lactobacillus gasseri, and Bifidobacterium breve are naturally occurring bacteria found in the human microbiota, as evidenced by pg. 2 para. 4 of Sagar et al. (Bifidobacterium breve and Lactobacillus rhamnosus treatment is as effective as budesonide at reducing inflammation in a murine model for chronic asthma. Respir Res. 2014 Apr 16;15(1):46).
Claim 5 limits the plant substrate to include vegetables and at least one fruit, nut, grain, cereal, or pseudo-cereal. Claim 6 limits the plant substrate to be oat. Claim 7 limits the plant substrate to be oat in combination with an oil selected from the group consisting of: corn oil, sunflower oil, and olive oil. Vegetables, fruits, nuts, grains, cereals (including oat), and pseudo-cereals (such as quinoa, amaranth, buckwheat) are naturally occurring plants. Corn, sunflowers, and olives are also naturally occurring plants that naturally produce oils, as evidenced by para. 1 and Table 1 of Mestrovic (Oils Rich in Linoleic Acid, https://www.news-medical.net/health/Oils-Rich-in-Linoleic-Acid.aspx, 18 June 2023, accessed 23 April 2026).
Claim 8 limits a CFU ratio of Lactobacillus rhamnosus, Lactobacillus gasseri, and Bifidobacterium breve in claim 1 to be 1:1:1. This merely limits the amount the naturally occurring Lactobacillus rhamnosus, Lactobacillus gasseri, and Bifidobacterium breve relative to each other, and does not recite any other non-natural compositional element. Claim 9 recites the probiotic blend used in the second fermentation of claim 1 further comprises Lactobacillus rhamnosus. As discussed above, Lactobacillus rhamnosus is a naturally occurring microorganism.
Claim 10 recites that the plant substrate is combined with donkey or sheep milk. Donkey and sheep milk are naturally occurring milks produced by donkeys and sheep, respectively.
Claim 11 recites the food item of claim 1 is in the form of a drink, cream, spread, or powder. Each of the these food forms do not introduce any non-natural components or structures that make the claimed food markedly different from that occurring in nature.
Claim 12 recites the food is in the form of a yogurt, milk, formula, fruit juice, soft-drink, baby food, or fruit jam. Yogurts, milk, fruit juices, baby foods, and fruit jams all comprise naturally occurring compositional elements, such as dairy, vegetables, and fruits, and these forms do not introduce or limit the claimed food to include non-naturally occurring components that would amount to significantly more than the product of nature. As discussed in the 35 USC §112(b) rejection of claim 12 above, the claim term “formula” is indefinite. The term “formula” is interpreted to be any food product or formulation, thus encompasses natural forms of foods. A soft drink is a non-natural form of food that is markedly different from what occurs in nature, so Applicant may consider amending claim 1 to limit the food composition to be in the form of a soft-drink in order to obviate this rejection.
Therefore the instant invention recites a judicial exception of a product of nature (Step 2A Prong One: Yes).
This judicial exception is not integrated into a practical application and the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims are directed to a food composition, and there are no active steps of applying or using the food composition for any practical means, nor any non-natural additional elements. Although claim 1 recites product-by-process language which describes how the claimed food item is produced, it is not limited by the first and second fermentation steps which produce the claimed food item. MPEP §2113(I) states that product-by-process claims are not limited by the manipulations of the process, only by the implied structure of the steps.
Therefore, the instant invention is not integrated into a practical application and does not include any additional elements that amount to significantly more than the recited judicial exception of a product of nature, so the instant invention is not patent eligible subject matter under 35 USC §101 (Step 2A Prong Two and Step 2B: No).
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-9 and 11-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Agayn et al. (WO 2017126959 A1, Published July 27, 2017).
Claim 1 recites product-by-process language which describe how the claimed product is produced. Claims 5-10 recite limitations that further limit the plant substrate and probiotic blend used in the fermentation steps in the product-by-process limitation. MPEP §2113(I) states that product-by-process claims are not limited by the manipulations of the process, only by the implied structure of the steps. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.
Regarding claims 1-6 and 8-9, Agayn teaches a food composition comprising up to 15 wt.% fermented cereals, nuts, fruits, vegetables, grains, and pseudo-cereals, including oat (Agayn pg. 3, lines 15-16, pgs. 4-5 bridging par., and pg 6, line 12). Agayn teaches that the fermenting microorganisms are Lactobacillus rhamnosus, Lactobacillus gasseri, and Bifidobacterium breve (Agayn pgs. 32-33 bridging para.).
Regarding claim 7, Agayn teaches the addition of sunflower or sesame oil to the food composition in order to control the final fat content (Agayn claim 25 line 2; Page 5, lines 26-30).
Regarding claims 11-12, Agayn teaches that the composition is a yogurt, a drink, a spread, or a powder (Agayn pg. 8-9 bridging para.). Agayn also teaches their fermented composition comprises fruits, and may be a plum jam (Agayn pg. 52 example 2).
Claim Rejections - 35 USC § 103
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.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Agayn as applied to claims 1-9 and 11-12 above, and further in view of Brumini et al. (Whey proteins and their antimicrobial properties in donkey milk: a brief review, Dairy Sci. & Technol. 96:1–14, Published July 23, 2015).
Agayn does not teach that the oat based fermented food product further contains donkey or sheep milk.
However, Brumini teaches that donkey milk is a good breast milk substitute during infancy and can provide adequate nourishment for patients with cow milk protein allergy (Brumini abstract sentence 2). Brumini continues to teach that donkey milk is known to possess natural protective antimicrobial factors and a specific epidermal growth factor (EGF) that suggest its beneficial impact on gastrointestinal mucosa health and integrity; a claim particularly valuable for children, the elderly, and convalescents, who have a reduced immune defense system (Brumini intro, second paragraph).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added Brumini’s donkey milk to Agayn’s food composition. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success in order to include the already known health benefits of donkey milk as taught by Brumini into Agayn’s final food product.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 and 10-11 of U.S. Patent No. 12,075,808 in view of Agayn et al. (NL 2016115 B1, published 25 July 2017).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims would be obvious over the conflicting claims in view of Agayn.
Regarding instant claims 1-4, conflicting claim 1 recites a fermented product obtained by fermenting a plant substrate with Lactobacillus rhamnosus, Lactobacillus gasseri, and Bifidobacterium breve, and conflicting claim 10 recites a food item comprising the fermented product.
However, the conflicting claims do not recite a specific weight percentage of the fermented product in the composition.
Agayn teaches a similar food composition comprising up to 15 wt.% fermented cereals, nuts, fruits, vegetables, grains, and pseudo-cereals, including oat (Agayn pg. 3 para. 2 and pgs. 4-5 bridging para.).
It would have been prima facie obvious to one of ordinary skill in the art to modify the conflicting claims’ food item to comprise up to 15 wt.% of a fermented product. One of ordinary skill in the art would be motivated to do so with a reasonable expectation of success because Agayn’s similar food composition comprises up to 15 wt.% fermented products, and Agayn teaches that the composition has additional health benefits and organoleptic properties (Agayn pg. 1 para. 1). Thus, one of ordinary skill in the art would recognize that including up to 15 wt.% of fermented product in the conflicting claims’ food item, they could impart additional health and organoleptic properties to the composition, just as Agayn teaches.
Regarding instant claim 5, conflicting claim 2 recites the plant substrate includes vegetables and at least one of a fruit, a nut, a grain, a cereal, and a pseudo-cereal.
Regarding instant claim 6, conflicting claim 3 recites the plant substrate is oat.
Regarding instant claim 7, conflicting claim 4 recites the plant substrate is oat in combination with an oil selected from the group consisting of: corn oil, sunflower oil, and olive oil.
Regarding instant claim 8, conflicting claim 5 recites the CFU ratio of L. rhamnosus, L. gasseri, and Bifidobacterium breve is 1:1:1.
Regarding instant claim 9, conflicting claim 6 recites the probiotic blend further comprises L. rhamnosus.
Regarding instant claim 10, conflicting claim 7 recites the plant substrate is combined with donkey or sheep milk.
Regarding instant claim 11, conflicting claim 11 recites the food item is in form of a drink, cream, spread or powder.
Regarding instant claim 12, the conflicting claims do not recite the food item as a yogurt, milk, formula, fruit juice, soft-drink, baby food, or fruit jam.
Agayn teaches that their similar composition is a yogurt, a drink, a spread, or a powder (Agayn pg. 8-9 bridging para.). Agayn also teaches their fermented composition comprises fruits, and may be a plum jam (Agayn pg. 52 example 2)
It would have been prima facie obvious to one of ordinary skill in the art to modify the conflicting claims’ food item to be a yogurt, a drink, a spread, a powder, or a fruit jam. One of ordinary skill in the art would be motivated to do so with a reasonable expectation of success because Agayn teaches several forms that a fermented food item may be made into, and that their food item has positive organoleptic properties, thus one of ordinary skill in the art would be motivated to formulate the conflicting claims’ food item in the manner described by Agayn in order to impart these beneficial organoleptic properties.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDER M DURYEE whose telephone number is (571)272-9377. The examiner can normally be reached Monday - Friday 9:00 am - 5:00 pm.
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/Alexander M Duryee/Examiner, Art Unit 1657 /LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
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