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 Group I (claims 1-4, 6-14 and 20-21) in the reply filed on 2/23/2026 is acknowledged. The traversal is on the ground(s) that the method "directly determines" the "structural and functional characteristics" of the product (see page 3, especially 2 11 d paragraph, of applicant's response of 2/23/2026). This is not found persuasive. The restriction requirement of 12/23/2025 explains why Groups I-Il lack unity (see page 3, especially last paragraph, and also see 1st two paragraph on page 4), which forms the basis for the restriction. Applicant has not provided any specific arguments against this establishment of lack of unity. As for applicant’s argument that the method "directly determines" the "structural and functional characteristics" of the product, it is noted that if a product claim has process details in the claims, it is considered a product-by-process claim. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. 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.' In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985), MPEP 21 13.
Still further, it is noted that withdrawn claims 15-19 depend at least from product claim l , and as such, if product claim I is found allowable, claims 15-19 will necessarily be rejoined as they require all limitations of the product claim (also see page 5, especially 2nd last paragraph of restriction requirement of 12/23/2025).
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The requirement is still deemed proper and is therefore made FINAL.
Claims 1-4, 6-14 and 20-21 have been elected and claims 15-19 have been withdrawn from further consideration.
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 1-4, 6-14, 20-21 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 1 recites the broad recitation “milk-derived products”, and the claim also recites “preferably a solution of milk derived dry products” which is the narrower statement of the range/limitation.
The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claims 4, 11 and 12 also have similar issues
Claim 4 recites the broad recitation “solution of milk-derived products”, and the claim also recites “preferably a solution of milk-derived dry products” which is the narrower statement of the range/limitation.
Claim 11 recites the broad recitation “bacteria ranges from 106-1011 CFU/serving”, and the claim also recites “preferably 107-109 CFU/serving” which is the narrower statement of the range/limitation.
Claim 12 recites the broad recitation “wherein the bacteria are viable at least after 12 days of aerobic storage conditions at 4°C-25°C”, and the claim also recites “preferably wherein the bacteria are viable at least after 4 weeks of aerobic storage conditions at 4°C-25°C” which is the narrower statement of the range/limitation.
The claim(s) 1, 4, 11 and 12 are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim Rejections - 35 USC § 102
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 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.
Claims 1-3 and 20-21 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by IDS NPL reference to Marcial-Coba et al. “Viability of microencapsulated Akkermansia muciniphila and lactobacillus plantarum during freeze drying, storage and in-vitro simulated upper gastrointestinal tract passage”, hereinafter Marcial-Coba.
Regarding claim l , Marcial-Coba teaches an encapsulated anaerobic bacteria (page 5868, col. 2, especially lines 6-11 gives examples of "anaerobic bacteria") obtained by spray drying (see product-by-process limitation note below) and encapsulation (page 5869, col. 2, lines 25-30 teaches "microencapsulation "; also see section 3.4 on page 5870) in a solution of milk derived products; preferably a solution of milk-derived dry products (such as "milk proteins" disclosed on page 5869, col. 2, lines 7-13; also see section 2.2 on page 5870 that discloses "skim milk"), wherein the encapsulated anaerobic bacteria are selected from Akkermansia muciniphila; Anaerobutyricum hallii; Faecalibacterium prausnitzii; wherein Faecalibacterium prausnitzii is one of the following: Faecalibacterium duncaniae, Faecalibacterium hattorii, Faecalibacterium gallinarum. or mixtures thereof (at least "Akkermansia muciniphila" is taught in page 5868, see col. 2, especially last 4 lines; and page 5870, col. 1, lines 14-17).
Whereas claim I is a product claim. it recites method of steps therein; i.e. "obtained by spray-drying" and that milk derived products are in a "solution" during a process of forming the encapsulated bacteria (but not in the final product). Whereas low moisture content of a product is a product limitation. the method of how moisture content is achieved (such as by "spray-drying" process) is a process limitation. As such claim 1 is a product-by-process claim. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. 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. In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
Regarding claim 3, Marcial-Coba teaches the encapsulated anaerobic bacteria according to claim 1 wherein the solution of milk derived product is a skim milk (see section 2.2 on page 5870 that discloses "skim milk").
Whereas claim 3 is a product claim, it recites method of steps therein; i.e. the "solution" for "encapsulation is "skim milk". This is because the structure of the product; i.e. final encapsulation is not a liquid like "skim milk", and it appears "skim milk" is just used during a process of making the "encapsulation" so that the final encapsulation material structure has "milk-derived dry products", and that composition comprising "milk-derived dry products" is already address in claim 1. As such claim 3 is a product-by-process claim. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. 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. In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
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Regarding claim 20, Marcial-Coba teaches encapsulated bacteria or particle according to claim 1, for use as a live biotherapeutic product or food additive (see page 5872, section 3.2, 1st sentence which describes use for "therapeutic treatment for gut"; also see abstract on page 5868, especially 1st sentence of abstract that describes use as "next-generation probiotic"; also see last sentence of section 4 on page 5876).
Regarding claim 21 , Marcial-Coba teaches encapsulated bacteria or particle according to claim 1, for use as a probiotic (see abstract on page 5868, especially 1st sentence of abstract that describes use as "next-generation probiotic"; also see last sentence of section 4 on page 5876).
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.
Claims 4-8 are rejected under 35 U.S.C. 103 as being unpatentable over Marcial-Coba.
Regarding claim 4, Marcial-Coba teaches a particle comprising a capsule (page 5869, col. 2, lines 25-30 teaches "microencapsulation "; also see section 3.4 on page 5870), wherein said capsule comprises a solution of milk derived products (such as "milk proteins" disclosed on page 5869, col. 2, lines 7-13; also see section 2.2 on page 5870 that discloses "skim milk"), preferably milk-derived dry products, in the shell and an anaerobic bacterium in the core, wherein the bacterium is selected from: Akkermansia muciniphila, Anaerobutyricum hallii, Faecalibacterium prausnitzii; wherein
Faecalibacterium prausnitzii is one of the following: Faecalibacterium duncaniae.
Faecalibacterium hattorii, Faecalibacterium gallinarum, or mixtures thereof (at least "Akkermansia muciniphila" is taught in page 5868, see col. 2, especially last 4 lines; and page 5870, col. 1, lines 14-17).
Marcial-Coba does not teach wherein "the amount of the solution of milk derived products ranges from 5-20% (v/v)". However, Marcial-Coba discloses use of milk proteins and skim milk ("milk proteins" disclosed on page 5869, col. 2, lines 7-13; also see section 2.2 on page 5870 that discloses "skim milk"), and it is known that relative amount of milk derived products will affect milk protein content of the product — higher the v/v of milk derived products comprising milk protein, higher the milk protein content. As the amount of the solution of milk derived products has been established as a results effective variable (as explained above), it would have been obvious to one of ordinary skill in art to modify Marcial-Coba so that the amount of the solution of milk derived products is a specific value/range, such as the claimed "the amount of the solution of milk derived products ranges from 5-20% (v/v)"; because it has been held that where the general conditions of the claims are discloses in the prior art, it is not inventive to discover the optimum or workable range by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) See MPEP 2144.05. Therefore, it would have been obvious to one of ordinary skills in the art before the time of the effective filing of the claimed invention to modify Marcial-Coba to optimize the amount of milk protein in the particle such as by employing "the amount of the solution of milk derived products ranges from 5-20% (v/v)". The ordinary artisan would have been motivated to modify Marcial-Coba for at least the purpose of making a product that is not only a probiotic but also provides useful milk protein for daily nutrition.
Regarding claim 6, Marcial-Coba teaches the particle according to claim 4 wherein the bacterium is Akkermansia muciniphila DSM 22959 (page 5870, col. 1, lines 1417 discloses "Akkermansia muciniphila DSM22959").
Regarding claim 7, Marcial-Coba teaches the panicle according to claim 4 but does not specifically teach wherein the quantity of anaerobic bacteria ranges "from 105 to 1010 CFU/g". However, Marcial-Coba teaches that dosage of anaerobic bacteria is a known variable and is influenced by several factors such as "the health endpoint, the specific strain and the delivery vehicle" and that effective dosage of traditional probiotics may "range between 109 — 10 11 CFI-J daily" (see page 5869, col. 1, lines 13-17) . As the quantity of anaerobic bacteria has been established as a results effective variable (as explained above), it would have been obvious to one of ordinary skill in art to modify Marcial-Coba so that the quantity of anaerobic bacteria is a specific value/range, such as the claimed "from 105 to 1010 CFU/g"; because it has been held that where the general conditions of the claims are discloses in the prior art, it is not inventive to discover the optimum or workable range by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) See MPEP 2144.05. Therefore, it would have been obvious to one of ordinary skills in the art before the time of the effective filing of the claimed invention to modify Marcial-Coba to adjust the quantity of anaerobic bacteria, such as the quantity of anaerobic bacteria ranges ""from 105 to 1010 CFU/g"". The ordinary artisan would have been motivated to modify Marcial-Coba for at least the purpose of making a product that satisfies daily requirement for most cases with a small number of doses in a day, such as taking 1-3 dozes daily as is typical for many medicines.
Regarding claim 8, Marcial-Coba teaches the particle according to claim 4 wherein the solution of milk derived products is a skim milk (see section 2.2 on page 5870 that discloses "skim milk"). Whereas claim 8 is a product claim, it recites method of steps therein; i.e. the "solution" for "encapsulation is "skim milk". This is because the structure of the product; i.e. final encapsulation is not a liquid like "skim milk", and it appears "skim milk" is just used during a process of making the "encapsulation" so that the final encapsulation material structure has "milk-derived dry products", and that composition comprising "milk-derived dry products" is already address in claim 1. As such claim 8 is a product-by-process claim. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. 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. In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
Claims 9-14 are rejected under 35 U.S.C. 103 as being unpatentable over Marcial-Coba in view of IDS NPL reference to Saaby et al, "Dark Chocolate as a stable carrier of microencapsulated Akkermansia muciniplhila and Lactobacillus casei", FEMS Microbiology Letters, 366, 2019, published December 20, 2018, hereinafter Saaby.
Regarding claims 9, Marcial-Coba teaches a foodstuff composition comprising the particle and/or the encapsulated anaerobic bacteria described in claim 1 but does not clearly teach a suitable food matrix is such that viable anaerobic bacteria are in "a chocolate matrix". Saaby teaches a similar encapsulated anaerobic bacteria, wherein the encapsulated anaerobic bacteria is also Akkermansia muciniphila (see ABSTRACT on page 1), wherein the anaerobic bacteria are embedded in chocolate matrix (see page 2, col. 2, last paragraph that describes "chocolate matrix"; also see ABSTRACT on page 1). It would have been obvious to one of ordinary skills in the art before the time of the effective filing of the claimed invention to modify MarciaI-Coba so that a suitable food matrix is such that viable anaerobic bacteria are in "a chocolate matrix". The ordinary artisan would have been motivated to modify Marcial-Coba for at least the purpose of using not only microencapsulation in gum matrix but additionally embedding in dark chocolate to confer efficient protection to the anaerobic bacteria making viable a next generation probiotic (see page 5, last paragraph, which is part of "CONCLUSION" of Saaby reference).
Regarding claim 10, Marcial-Coba teaches the foodstuff composition according to the previous claim 9 wherein the suitable food matrix is selected from: dairy products, cereal matrix, oil matrix, sugar matrix, chocolate matrix, soy milk matrix, juice matrix, vegetable matrix and fruit matrix (at least "chocolate matrix" is explained for claim 9 above).
Regarding claim 11, Marcial-Coba teaches the foodstuff composition according to claim 9 but does not clearly state wherein the amount of particle and/or the encapsulated anaerobic bacteria ranges "from 106 - 1011 CFU/serving, preferably 107 - 109 CFU/serving". However, Marcial-Coba teaches that effect of an administered probiotic on a host is influenced by several factors like the "health endpoint, the specific strain and the delivery vehicle", and that effective dosage of traditional probiotics may "range between 10 9 - 1 0 11 CFL) daily" (see page 5869, col. 1, lines 13-17). As the amount of the encapsulated anaerobic bacteria has been established as a results effective variable (as explained above), it would have been obvious to one of ordinary skill in art to modify Marcial-Coba so that the amount of the encapsulated anaerobic bacteria is a specific value/range, such as the claimed ranges "from 106 - 1011 CFU/serving, preferably 107 - 109 CFU/serving"; because it has been held that where the general conditions of the claims are discloses in the prior art, it is not inventive to discover the optimum or workable range by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) See MPEP 2144.05. Therefore, it would have been obvious to one of ordinary skills in the art before the time of the effective filing of the claimed invention to modify Marcial-Coba so that the amount of particle and/or the encapsulated anaerobic bacteria ranges "from 106 - 1011 CFU/serving, preferably 107 - 109 CFU/serving". The ordinary artisan would have been motivated to modify MarciaI-Coba for at least the purpose of making a product that satisfies daily requirement for most cases with a small number of doses in a day, such as taking 1-3 dozes daily as is typical for many medicines.
Regarding claim 12, Marcial-Coba teaches the foodstuff composition according to claim 9 wherein the bacteria are viable at least after 12 days of aerobic storage conditions at 4 0 C.-25 0 C.; preferably wherein the bacteria are viable at least after 4 weeks of aerobic storage conditions at 4 0 C.-25 0 C (see "aerobic storage" viability especially "30 days of aerobic storage at WC" on page 5873, col. 2, 2nd last paragraph; also see Table 4 on page 5873 that compares viability for both "Aerobic storage" and "Anaerobic storage ").
Regarding claim 13, Marcial-Coba teaches foodstuff comprising the composition described in claim 9 (as described for claim 9, the composition is food stuff that comprises chocolate and as such is a chocolate food supplement).
Regarding claim 14, Marcial-Coba teaches foodstuff according to the previous claim 13 wherein the foodstuff is cheese, yogurt, ice-cream, plant-based yoghurt-type product, beverage, juice, chocolate food supplement, cereal bar (as described for claim 9, the composition is food stuff that comprises chocolate and as such is a chocolate food supplement).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JYOTI CHAWLA whose telephone number is (571)272-8212. The examiner can normally be reached M-F 9:30- 5:30.
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/JYOTI CHAWLA/Primary Examiner, Art Unit 1791
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