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 1-10 and 13-22 are pending.
Election/Restrictions
Applicant’s election of Group I, claims 1-10, in the reply filed on 02 June 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 13-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02 June 2026.
Claims 1-10 are under examination.
Priority
Applicant’s claim for priority to the filing date of EP21383147.2 filed 16 December 2021 and PCT/EP2022/086359 filed 16 December 2022 is acknowledged. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
The effective filing date is 16 December 2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06 January 2025 is being considered by the examiner.
Claim Objections
Claim 6 is objected to because of the following informalities:
Claim 6 recites the postbiotic composition is a solid formulation selected from the group consisting of tablets, lozenges, sweets, chewable tablets, chewing gum, capsules, sachets, powders, gels, granules, coated particles or coated tablets, tablets and gastro-resistant tablets and capsules and dispersible strips and films.
The Markush group of solid formulations recites several “and” and “or” conjugations. A Markush group is a closed listing of alternatives, so all of the additional “and” and “or” conjugations other than the terminal “and” before “films” are unnecessary and should be deleted:
6. The postbiotic composition according to claim 5, wherein the postbiotic composition is a solid formulation selected from the group consisting of tablets, lozenges, sweets, chewable tablets, chewing gum, capsules, sachets, powders, gels, granules, coated particles, coated tablets, gastro-resistant tablets, gastro-resistant capsules, dispersible strips, and films.
Appropriate correction is required.
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 1-10 are rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, as failing to comply with the enablement requirement. The claim(s) 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.
It is apparent that biological material Bifidobacterium longum strain CECT 7347 and Lactobacillus rhamnosus strain CECT 8361 are required to practice the claimed invention. As such the biological materials must be known and readily available or obtainable by a repeatable method set forth in the specification, or otherwise known and readily available to the public. If it is not so obtainable or available, the requirements of 35 USC 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, may be satisfied by a deposit of the biological material Bifidobacterium longum strain CECT 7347 and Lactobacillus rhamnosus strain CECT 8361.
The process disclosed in the specification does not appear to be repeatable, it is not clear that the invention will work with commonly available material and it is not apparent if the Bifidobacterium longum strain CECT 7347 and Lactobacillus rhamnosus strain CECT 8361 that are considered necessary to make and use the invention is both known and readily available to the public.
It is noted that Applicants have deposited Bifidobacterium longum strain CECT 7347 and Lactobacillus rhamnosus strain CECT 8361 under the terms of the Budapest Treaty (Specification pg. 2 lns. 15-26), but there is no indication in the specification as to public availability.
A statement, affidavit or declaration by Applicants, or by an attorney of record over his or her signature and registration number, or by someone in a position to corroborate the facts of the deposit, that all restrictions imposed by the depositor on the availability to the public on the deposited material will be irrevocably removed upon granting of the patent, would satisfy the deposit requirement made herein.
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.
Claim 4 is 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.
Claim 4 recites the composition of claim 3 comprises a pharmaceutically acceptable carrier and/or an excipient. It is unclear if claim 4 limits the composition of claim 3 to now only comprise a pharmaceutically acceptable carrier and/or excipient, or if claim 4 limits the composition of claim 3 to further comprise a pharmaceutically acceptable carrier and/or excipient in addition to the recited compositional elements in claim 3.
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 1-10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to the judicial exception of product of nature without significantly more.
Claims 1-10 are drawn to the statutory category of a composition of matter (Step 1: Yes).
Claims 1-3, 5, 8, and 10 recite a postbiotic composition comprising non-viable Bifidobacterium longum strain CECT 7347 and Lactobacillus rhamnosus strain CECT 8361. The only recited components within the composition are non-viable cells of Bifidobacterium longum strain CECT 7347 and Lactobacillus rhamnosus strain CECT 8361. Both bacterial strains Bifidobacterium longum strain CECT 7347 and Lactobacillus rhamnosus strain CECT 8361 were isolated from the feces of a human infant, as evidenced by Specification pg. 2 lns. 15-26. As such, the two bacterial strains are naturally occurring bacteria. There is no evidence within the claims or disclosure that the Bifidobacterium longum strain CECT 7347 and Lactobacillus rhamnosus strain CECT 8361 have undergone any artificial processes that would render them markedly different from their natural counterparts.
Claim 4 recites the postbiotic composition comprises a pharmaceutically acceptable carrier and/or excipient. The disclosure does not provide a specific limiting definition for the phrase “pharmaceutically acceptable carrier and/or excipient”. The broadest reasonable interpretation of the term includes naturally occurring compounds such as water.
Claim 6 recites the solid postbiotic composition of claim 5 is formulated as tablets, lozenges, sweets, chewable tablets, chewing gum, capsules, sachets, powders, gels, granules, coated particles or coated tablets, tablets and gastro-resistant tablets and capsules and dispersible strips and films. The broadest reasonable interpretation of the terms capsules, powders, gels, granules, coated particles, and films includes natural forms of the postbiotic composition such as naturally dried bacteria and biofilms comprising the natural bacterial strains, and there is no evidence in the disclosure that these alternative forms of the claimed natural composition comprise any markedly different characteristics as compared to the claimed natural product. However, tablets, lozenges, sweets, chewable tablets, chewing gum, sachets, coated tablets, gastro-intestinal tablets, and dispersible strips are non-natural formulations of the composition that add markedly different characteristics, thus would render claim 6 patent eligible if Applicant amended the claim to limit the solid composition to those formulations..
Claim 7 recites the liquid postbiotic composition of claim 5 is formulated as an oral solution, suspension, droplet, emulsion, or syrup. The broadest reasonable interpretation of the terms oral solution, suspension, and droplet includes natural forms of the postbiotic composition such as a water-based solution/suspension/droplet comprising the natural bacteria, and there is no evidence in the disclosure that these alternative forms of the claimed natural composition comprise any markedly different characteristics as compared to the claimed natural product. However, emulsions and syrups are non-natural formulations of the composition that add markedly different characteristics, thus would render claim 7 patent eligible if Applicant amended the claim to limit the liquid composition to those formulations.
Claim 9 recites the nutritional composition of claim 8 is a food selected from the group consisting of: fruit or vegetable juices, ice cream, infant formula, milk, yogurt, cheese, fermented milk, powdered milk, cereals, baked goods, milk-based products, meat products and beverages. The broadest reasonable interpretation of the term fruit and vegetable juices, milk, fermented milk, powdered milk, cereals, milk-based products, meat products, and beverages includes naturally occurring compositional elements, including natural juices, milk, cereal grains, and meat that comprise the natural bacteria, and there is no evidence in the disclosure that these forms of the claimed natural composition comprise any markedly different characteristics as compared to the claimed natural product. However, ice cream, infant formulas, yogurt, cheese, and baked goods are non-natural formulations of the composition that add markedly different characteristics, thus would render claim 9 patent eligible if Applicant amended the claim to limit the foods to those forms.
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 do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims are directed toward a natural composition, but do not recite any practical application of the composition for a specific therapeutic or functional purpose. The claims lack any method steps of applying the composition for a practical purpose.
Therefore, the instant invention is directed to the judicial exception of a product of nature and does not include any additional elements that amount to significantly more than the recited judicial exception of a product of nature, and 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 1-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Navarro et al. (EP 3222282 A1, published 27 September 2017), as evidenced by Salminen et al. (The International Scientific Association of Probiotics and Prebiotics (ISAPP) consensus statement on the definition and scope of postbiotics. Nat Rev Gastroenterol Hepatol 18, 649–667 (2021). https://doi.org/10.1038/s41575-021-00440-6).
Regarding claims 1 and 3, Navarro teaches a pharmaceutical, nutritional, and/or food composition comprising the bacterial strains Bifidobacterium longum strain CECT 7347 and non-viable Lactobacillus rhamnosus strain CECT 8361 (Navarro pg. 1 Abstract, [21]). Navarro also teaches that compositions comprise cellular components, metabolites, and molecules secreted by Bifidobacterium longum strain CECT 7347 and non-viable Lactobacillus rhamnosus strain CECT 8361, wherein the cellular components, metabolites, and molecules of the bacteria include: components of the cell wall such as peptidoglycan, nucleic acids, membrane components, proteins, lipids, carbohydrates, lipoproteins, glycolipids, glycoproteins, organic and inorganic acids, peptides, amino acids, enzymes, vitamins, salts, minerals, or nucleic acids (Navarro [20]).
The art recognized definition of a postbiotic is “a preparation of inanimate microorganisms and/or their components that confers a health benefit on the host”, as evidenced by Salminen Abstract. Although Navarro does not use the term “postbiotic” to describe their composition, Navarro’s composition as described in Navarro [20] would be considered by one of ordinary skill in the art to be a postbiotic composition because it comprises cellular components, metabolites, and secreted molecules of Bifidobacterium longum strain CECT 7347 and non-viable Lactobacillus rhamnosus strain CECT 8361.
Regarding claim 2, the claim recites that the non-viable bacterial strains are heat-treated, which is product-by-process language which describe how the claimed products are produced. 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 claim 4, Navarro teaches the composition also includes pharmaceutically acceptable carriers and/or excipients (Navarro [24]-[27]).
Regarding claim 5, Navarro teaches the composition is in a solid or liquid form (Navarro [29]).
Regarding claim 6, Navarro teaches the composition maybe in the form of tablets, lozenges, sweets, chewable tablets, chewing gums, capsules, sachets, powders, gels, granules, coated particles, coated tablets, gastro-resistant tablets, gastro-resistant capsules, dispersible strips, and films (Navarro [29]-[30]).
Regarding claim 7, Navarro teaches the liquid formulation is selected from the group consisting of oral solutions, suspensions, emulsions, and syrups (Navarro [31]).
Regarding claim 8, Navarro teaches that the nutritional composition comprises a food or a nutritional supplement (Navarro [34]).
Regarding claim 9, Navarro teaches that the food component is selected from the group consisting of: fruit or vegetable juices, ice cream, infant formula, milk, yogurt, cheese, fermented milk, powdered milk, cereals, baked goods, milk-based products, meat products and beverages (Navarro [38]).
Regarding claim 10, Navarro teaches the concentration of Bifidobacterium longum strain CECT 7347 and non-viable Lactobacillus rhamnosus strain CECT 8361 in the composition is between 103 to 1012 CFU (Navarro [44]).
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 coplete 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 1-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-4, and 6-8 of U.S. Patent No. 10,434,127 B2 in view of Salminen et al. (The International Scientific Association of Probiotics and Prebiotics (ISAPP) consensus statement on the definition and scope of postbiotics. Nat Rev Gastroenterol Hepatol 18, 649–667 (2021). https://doi.org/10.1038/s41575-021-00440-6) and Navarro et al. (EP 3222282 A1, published 27 September 2017).
Regarding instant claim 1, conflicting claim 1 recites a formulation comprising Bifidobacterium longum strain CECT 7347 and Lactobacillus rhamnosus strain CECT 8361.
The conflicting claims do not recite the formulation is a postbiotic composition comprising non-viable Bifidobacterium longum strain CECT 7347 and Lactobacillus rhamnosus strain CECT 8361.
Salminen teaches that postbiotics are preparations of inanimate microorganisms and/or their components that confers a health benefit on the host (Salminen Abstract). Salminen also teaches advantages of postbiotics as compared to probiotic compositions such as that recited in conflicting claim 1, particularly that postbiotics are more stable than probiotics due to not having to keep the organisms alive (Salminen pg. 652 sec. Stability para. 1), and that postbiotics are inherently safer that probiotics because the microorganisms they contain do not have the capacity to replicate so cannot cause bacteremia or fungemia (Salminen pg. 654 sec. Safety).
It would have been prima facie obvious to one of ordinary skill in the art to modify the conflicting claim’s formulation to comprise non-viable Bifidobacterium longum strain CECT 7347 and Lactobacillus rhamnosus strain CECT 8361 thereby transforming the formulation into a postbiotic composition. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success because Salminen teaches stability and safety advantages of postbiotic compositions comprising non-viable microorganisms over probiotic compositions comprising live microorganisms, so one of ordinary skill in the art would be motivated to reformulate the conflicting claims’ composition as a postbiotic in order to increase the stability and safety of the composition, without sacrificing therapeutic effectiveness.
Regarding instant claim 2, the claim recites that the non-viable bacterial strains are heat-treated, which is product-by-process language which describe how the claimed products are produced. 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 recited in the conflicting claims, the claim is unpatentable even though the prior product was made by a different process.
Regarding instant claim 3, conflicting claim 3 recites the formulation is a pharmaceutical or nutritional formulation.
Regarding instant claim 4, conflicting claim 4 recites the pharmaceutical formulation comprises a pharmaceutically acceptable carrier and/or excipient.
Regarding instant claims 5-7, the conflicting claims do not recite the composition is in a solid or liquid form, or in the form of tablets, lozenges, sweets, chewable tablets, chewing gums, capsules, sachets, powders, gels, granules, coated particles, coated tablets, gastro-resistant tablets, gastro-resistant capsules, dispersible strips, films, oral solutions, suspensions, emulsions, or syrups.
Navarro teaches the composition is in a solid or liquid form (Navarro [29]). Navarro teaches the composition maybe in the form of tablets, lozenges, sweets, chewable tablets, chewing gums, capsules, sachets, powders, gels, granules, coated particles, coated tablets, gastro-resistant tablets, gastro-resistant capsules, dispersible strips, and films (Navarro [29]-[30]). Navarro teaches the liquid formulation is selected from the group consisting of oral solutions, suspensions, emulsions, and syrups (Navarro [31]).
It would have been prima facie obvious to one of ordinary skill in the art to modify the conflicting claims’ formulation to be in the solid or liquid forms taught by Navarro because doing so would transform the conflicting claims’ pharmaceutical and nutritional formulations into administrable and marketable forms of the formulation.
Regarding instant claim 8, conflicting claim 6 recites the nutritional formulation is a functional food or a nutritional supplement.
Regarding instant claim 9, conflicting claim 7 recites the food is selected from the group consisting of a dairy product, a meat product, a vegetable product, an animal feed and a beverage.
Regarding instant claim 10, conflicting claim 8 recites the total concentration of microorganisms of the strains Lactobacillus rhamnosus CECT 8361 and Bifidobacterium longum CECT 7347 in the formulation is between 106 and 1012 cfu, and conflicting claim 10 recites the total concentration of microorganisms of the strains Lactobacillus rhamnosus CECT 8361 and Bifidobacterium longum CECT 7347 in the formulation is 109 cfu.
Claims 1-3 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,912,802 B2 in view of Salminen et al. (The International Scientific Association of Probiotics and Prebiotics (ISAPP) consensus statement on the definition and scope of postbiotics. Nat Rev Gastroenterol Hepatol 18, 649–667 (2021). https://doi.org/10.1038/s41575-021-00440-6).
Regarding instant claim 1 and 3, conflicting claim 1 recites a probiotic composition comprising Bifidobacterium longum strain CECT 7347 and Lactobacillus rhamnosus strain CECT 8361.
The conflicting claims do not recite the composition is a postbiotic composition comprising non-viable Bifidobacterium longum strain CECT 7347 and Lactobacillus rhamnosus strain CECT 8361.
Salminen teaches that postbiotics are preparations of inanimate microorganisms and/or their components that confers a health benefit on the host (Salminen Abstract). Salminen also teaches advantages of postbiotics as compared to probiotic compositions such as that recited in conflicting claim 1, particularly that postbiotics are more stable than probiotics due to not having to keep the organisms alive (Salminen pg. 652 sec. Stability para. 1), and that postbiotics are inherently safer that probiotics because the microorganisms they contain do not have the capacity to replicate so cannot cause bacteremia or fungemia (Salminen pg. 654 sec. Safety).
It would have been prima facie obvious to one of ordinary skill in the art to modify the conflicting claim’s probiotic composition to be a postbiotic composition comprising non-viable Bifidobacterium longum strain CECT 7347 and Lactobacillus rhamnosus strain CECT 8361. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success because Salminen teaches stability and safety advantages of postbiotic compositions comprising non-viable microorganisms over probiotic compositions comprising live microorganisms, so one of ordinary skill in the art would be motivated to reformulate the conflicting claims’ composition as a postbiotic in order to increase the stability and safety of the composition, without sacrificing therapeutic effectiveness.
Regarding instant claim 2, the claim recites that the non-viable bacterial strains are heat-treated, which is product-by-process language which describe how the claimed products are produced. 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 conflicting claims, the claim is unpatentable even though the prior product was made by a different process.
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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