DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Applicant’s response filed 12/22/2025 has been received and entered into the case. Claims 18-30, 48-55, 57-61, 63-66 are pending and have been considered on the merits herein. All arguments and amendments have been considered.
Interference
There are on-going court proceedings involving the Interference of parent application 14/443926, Interference No. 106,130.
In light of the Court Decision in Interference No. 106,130, filed by applicant on 12/22/2025, which states on p. 75 that “In regard to the pharmaceutical composition alternative of the count, which is drawn to a composition formulated for oral delivery and comprising a therapeutically effective amount of a substantially purified Akkermansia. (See Kaplan Motion 2, Paper 84, 8:22-25.) Kaplan cites to the disclosure in the abstract of the '824 provisional application of pharmaceutical compositions purified microbiota from the "phyla such as Bacteriodetes, Proteobacteria, and Verrucomicrobia or orders such as Bacteriodales, Verrucomicrobiales, and Enterobacteriales, and a pharmaceutically acceptable carrier," but not Akkermansia. ('824 appl., Ex. 1010, abstract.) Kaplan also cites to the general disclosure in the application of "substantially purified" microbiota, of at least 50%." (Id. at 1 80; see Kaplan Motion 2, Paper 84, 9:6-16.) Again, Kaplan does not direct us to a specific disclosure of a composition of purified Akkermansia.” And p. 77, which states “(Cani Opp. 2, Paper 225, 5:15-19.) We agree with Cani that Kaplan does not direct us to an experiment or other disclosure in the '824 application that provides credible evidence showing a substantially purified strain of Akkermansia can elicit therapeutic effects when administered orally to a subject. (See Cani Opp. 2, Paper 225, 6:1-3.) We also agree that the mere mention of Akkermansia as a member of the family Verrucomicrobia not the disclosure of treating a metabolic disorder with an "effective amount of bacteria consist[ing] essentially of viable Akkermansia" or of a composition for oral delivery of a therapeutically effective amount of a "substantially purified strain of Akkermansia," as required in the 1(c) and 1(d) alternatives of the count. (See Cani Opp. 2, Paper 225, 6:6-7; see '824 appl., Ex. 1010, 11 52, 79, Fig. 14.)”, and p. 80, which states that “Kaplan argues that the disclosure in the '824 application that Akkermansia is a genus of Verrucomicrobia would indicate a pure culture to one of ordinary skill in the art, but the support Kaplan cites is unpersuasive. (See Kaplan Reply 1, Paper 315, 6:6-16.) Specifically, Dr. Goodman's testimony that Akkermansia muciniphilia was known to be a gut bacterium says nothing about possession of a pure culture of that bacterium. (See id., citing Goodman Decl., Ex. 1501, 1 158.) Similarly, Dr. Cani's statement that reference to "Akkermansia" means "Akkermansia muciniphilia" says nothing about possession of a pure culture thereof when one simply has an entire mouse gut microbiota. (See Ex. 1566, 72:6- 12.) Kaplan's conclusion that "when Kaplan's Provisional '824 referred to Akkermansia, the skilled artisan would understand that Kaplan was referring to the species Akkermansia muciniphilia," is not relevant to whether the application describes a pure culture. (Kaplan Reply 2, Paper 315, 6:15-16; see Kaplan Motion 2, Paper 84, 12:11-12, citing '824 appl., Ex. 1010, T 138.) Kaplan also argues that "Dr. Goodman's testimony supports that based on the data in Provisional '824, the POSA would understand that oral administration of Verrucomicrobia, of which the only disclosed genus is Akkermansia, would provide the desired result of treating a metabolic disorder." (Kaplan Reply 1, Paper 315, 8:19-22.) This argument is unpersuasive because, regardless of what Dr. Goodman would do (see, e.g., Goodman Depo., Ex. 2298, 147:18-148:11, 152:5- 12; 143:2-11), Kaplan does not cite to testimony showing that a purified culture of Akkermansia was used in the '824 application. We are not persuaded that the mere mention of Akkermansia as an embodiment of Verrucomicrobia is the disclosure of a culture purified for Akkermansia to any degree.”, and p. 81, stating “Kaplan fails to persuade us that the '824 provisional application discloses a sufficient written and enabled description of an embodiment of the count. Thus, we are not persuaded that the '824 application is a constructive reduction to practice of the count and we deny Kaplan Motion 2.”
Thus, Kaplan is denied the benefit of the filing date of 2/29/2012 to provisional application 61/604824 and receives the priority date of 2/28/2013.
Therefore, in light of the Kaplan references not providing sufficient written and enabled description of a composition comprising purified Akkermansia and thus receiving the earliest benefit of 2/28/2013; the rejections of Claim(s) 18-28, 30, 48, 51-64 rejected under pre-AIA 35 U.S.C. 102(e) as being anticipated by each of Kaplan et al (US2013/0224155), WO2013/130773 A2, and Kaplan et al. (US10149867), Claims 18-25, 27-30, 49, 50, 52-64 rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over EP2103226 A1 in view of Kaplan et al (US2013/0224155, WO2013/130773 A2 and Kaplan et al. (US10149867), Claim 18-25, 27-30, 49, 50, 52-64 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of copending Application No. 18684682 (reference application) in view of each of Kaplan et al (US2013/0224155), WO2013/130773 A2, and Kaplan et al. (US10149867), and Claim 18-25, 27-30, 49, 50, 52-64 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of copending Application No. 18035766 (reference application) in view of each of Kaplan et al (US2013/0224155), WO2013/130773 A2, and Kaplan et al. (US10149867) are withdrawn.
In light of applicants claim amendments, the rejection of Claim(s) 18, 19, 21, 23-29, 48-52 rejected under pre-AIA 35 U.S.C. 102(a) and (b) as being anticipated by Derrien et al. (Frontiers in Micro., 2011, IDS) is withdrawn.
Priority
This application is a DIV of parent 14443829 (filed 5/19/2015) which is a 371 of PCT/EP2012/073011 filed 11/19/2012 and PCT/EP2013/073972 filed on 11/15/2013. The claims receive the earliest filing date of 11/19/2012 (to PCT/EP2012/073011).
Specification
The disclosure is objected to because of the following informalities: Specifically, the specification does not disclose the term “non-digestible oligosaccharide” nor a glucooligosaccharide, xylooligosaccharide, an arabinogalactan, galactomannan, and/or derivatives thereof according to claims 58, 63, and 64.
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.
Claim 65 is 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 claim limitation of “…wherein the composition is…encapsulated by a coating, wherein the coating does not fully degrade until after it exits the stomach of a subject” introduces new matter, which is not described in the specification as originally filed. Applicants’ specification only mentions excipients which may include coatings (0058) yet does not disclose “the composition is…encapsulated by a coating, wherein the coating does not fully degrade until after it exits the stomach of a subject”. Therefore, “…the composition is…encapsulated by a coating, wherein the coating does not fully degrade until after it exits the stomach of a subject” changes the scope of the claims and applicants’ invention for which no support is provided. This is a new matter rejection.
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 18-30, 48-55, 57-64, 66 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception, i.e., a product of nature, without significantly more. The claim(s) recite(s) a product comprising substantially purified Akkermansia , a prebiotic, and wherein the product is water. The product may comprise additional microorganisms. This judicial exception is not integrated into a practical application because the claims are directed to a product of nature comprised entirely of naturally occurring components with no practical application.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the product of nature claims does not exhibit markedly different characteristics from its naturally occurring counterpart in its natural state. “If the claim includes a nature-based product that does not exhibit markedly different characteristics from its naturally occurring counterpart in its natural state, then the claim is directed to a ‘product of nature’ exception (Step 2A: YES), and requires further analysis in Step 2B to determine whether any additional elements in the claim add significantly more to the exception and do they integrate the exception into a practical application. It is important to keep in mind that product of nature exceptions include both naturally occurring products and non-naturally occurring products that lack markedly different characteristics from any naturally occurring counterpart.” MPEP 2106.04(b)(ll). “The markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state. Markedly different characteristics can be expressed as the product’s structure, function, and/or other properties, and are evaluated based on what is recited in the claim on a case-by-case basis.
Here, the claims are directed towards a product comprising an amount of a bacteria and a prebiotic, both naturally occurring products and their combination does not change their structure or function. The “substantially purified” limitation does not change the product enough to make it different from what exists in nature. It should be noted that applicants define “substantially purified” as meaning that Akkermansia is comprised in a sample wherein it represents at least about 50% or more of the bacterial strain or fragments thereof in the sample, p. 11, lines 1-5. In the case of Myriad, the isolation resulted in a different structural characteristic; however otherwise, the isolated compound was structurally identical as well as having the same functional characteristic, thus the product was not markedly different from its naturally occurring counterpart and is directed to a product of nature. The claims encompass naturally occurring microbial composition which has been substantially purified and including naturally occurring prebiotics and is thus compared to its closest naturally occurring counterpart to determine its markedly different characteristics, which is a naturally occurring microorganism of the gut and naturally occurring prebiotics found in vegetables, fruits, and grains, for example. When looking to applicants’ specification, Akkermansia is disclosed to be a natural inhabitant of the gut as well Bacteriodetes, Lactobacillus, Prevotella, Bifidobacaterium, Escherichia and Clostridium (p. 3, lines 10-18, for example, see also Derrien et al. (Frontiers in Microb., 2011, cited herein and Belzer (2012, p. 1453, The case of Akkermansia section) in parent 14443829) and thus, the claimed product does not display markedly different characteristic compared to the naturally occurring counterpart, and thus is a product of nature. Regarding Step 2B, the claims do not recite any additional elements. Thus, the claim is directed to a judicial exception. Next, one must evaluate whether the claims as a whole integrate the judicial exception into a practical application, thereby imposing a meaningful limit on the judicial exception. Thus, one must identify whether there are any additional elements recited in the claim beyond the judicial exception. In the instant claims, there is not a practical application beyond the judicial exception.
The claimed invention is not directed to patent eligible subject matter. Based upon an analysis with respect to the claim as a whole, claim(s) 18-30, 48-55, 57-64, 66 is/are determined to be directed to a judicial exception.
For these reasons the claims are rejected under section 101 as being directed tonon-statutory subject matter.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 18-30, 48-55, 57-61, 63, 64 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over EP2103226 A1 in view of Derrien et al. (Frontiers in Micro., 2011, IDS).
Regarding claims 18, 23, 24, 27, 28, 30, 52, 53, 54, 59, 60, EP’226 teaches a food composition comprising probiotic bacteria (which inhabit our GI tract) including Akkermansia and further may include one or more of Lactobacillus, Bifidobacterium, Veillonella, Desemzia, Coprococcus, Collinsella, Citrobacter, Turicibacter, Sutterella, Subdoligranulum, Streptococcus, Sporobacter, Sporacetigenium, Ruminococcus, Roseburia, Proteus, Prevotella, Parabacteroides, Papillibacter, Oscillospira, Melissococcus, Dorea, Dialister, Clostridium, Cedecea, Catenibacterium, Butyrivibrio, Buttiauxella, Bulleidia, Bilophila, Bacteroides, Anaerovorax, Anaerostopes, Anaerofilum, Enterobacteriaceae, Fermicutes, Atopobium, Alistipes, Acinetobacter, Slackie, Shigella, Shewanella, Serratia, Mahella, Lachnospira, Klebsiella, Idiomarina, Fusobacterium, Faecalibacterium, Eubacterium, Enterococcus, Enterobacter, Eggerthella.
Regarding claims 18-20, the product is a liquid food, including dairy drinks, fruit juices (0010), yogurt, cheese (0019), milk (0021).
Regarding claims 21 and 22, the product is for animal and human consumption (0004).
Regarding claims 29, 49, 50, the product contains from 106 to 109 CFU (0028).
Regarding claims 57-58, 62-64, the product comprises a prebiotic including non-digestible oligosaccharides, fructo and galacto-oligosaccharides, inulin, fucose- oligosaccharides (0030).
EP’226 is silent regarding the amount of Akkermansia in the product, i.e. substantially purified Akkermansia comprises at least 50% of a strain of Akkermansia.
Derrien teaches a composition comprising substantially purified A. muciniphila comprising at least 50% of the strain given that A. muciniphila is the only strain in the composition (which is administered to mice). Derrien teaches the composition to comprise 109 cfu dose of A. muciniphila (p. 4, Results section). Derrien teaches that the colonization of the gut leads to gut immune homeostasis (non-inflammatory) and altered expression of genes responsible for membrane metabolism, antigen presentation of leukocytes, metabolic and signaling pathways, and lipid metabolism (p. 6, 1st and 2ⁿᵈ col.). They also teach that the mucin degrading microbe is decreased in overweight subjects as well as IBD patients and during appendicitis but is abundant in healthy subjects thus it is associated with a healthy mucosa (p. 2, last parag.-2nd col.).
The specification discloses that, the term “substantially purified” means that Akkermansia muciniphila or fragment thereof is comprised in a sample wherein it represents at least about 50%, preferably at least about 60, 70, 80, 85, 90, 95, 99% or more of the bacterial strains or fragment thereof of said sample (0047). Thus, the “substantially purified” limitation is directed to the amount of bacteria in the composition.
Thus, at the time of the claimed invention, determining the amount of Akkermansia to be in the product would have been well within the purview of one of ordinary skill in the art and one could have pursued known options within his or her technical grasp with a reasonable expectation of success.
Claims 65 and 66 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over EP2103226 A1 in view of Derrien et al. (Frontiers in Micro., 2011, IDS) as applied to claims 18-30, 48-55, 57-61, 63, 64 above, and further in view of Porubcan et al. (US20120009256 A1) and Everard 2011, IDS.
The teachings of EP2103226 A1 in view of Derrien are found above.
The references do not teach the composition to be encapsulated by a coating.
However, at the time of the claimed invention, encapsulating probiotic/prebiotic compositions was known, as disclosed by Porubcan, who teach probiotic/prebiotic compositions which are formulated for oral delivery and are encapsulated by an enteric coating to allow the composition to reach and be active in the intestines (0002, 0011, 0020-0022, Ex. 15, 0065).
Therefore, it would have been obvious to one of ordinary skill in the art to formulate probiotic/prebiotic compositions which have their effect in the gut/intestinal mucosa to comprise a coating allowing the composition to remain stable until it reaches the intestinal tract.
Regarding claim 66, “the amount” is not claimed, and thus, is interpreted to be any amount, which is suitable for promoting weight loss.
The intended use of the claimed composition does not patentably distinguish the composition, per se, since such undisclosed use is inherent in the reference composition. In order to be limiting, the intended use must create a structural difference between the claimed composition and the composition of the prior art. In the instant case, the intended use fails to create a structural difference, thus, the intended use is not limiting. Please note that when applicant claims a composition in terms of function, and the composition of the prior art appears to be the same, the Examiner may make rejections under both 35 U.S.C 102 and 103 (MPEP 2112). Moreover, the claimed function must be inherent to the reference composition. The discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new. Thus the claiming of a new use, functions or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. (MPEP 2112)
Additionally, Everard teach that obesity and metabolic disorders are closely associated with a low-grade inflammatory state and that gut microbiota plays a critical role in the development of diabetes, obesity and insulin resistance. Everard study gut microbiota changes and metabolism in obese mice. They find that when obese mice are fed prebiotics, a wide shift in gut microbiota is seen and obesity and metabolic disorders are reduced and treated. Specifically, Everard see a dramatic increase in A. muciniphila in prebiotic fed obese mice compared to control mice. They teach that A. muciniphila is associated with a healthy mucosa and inversely correlated to body weight and increasing after RYGB surgical procedures (see entire document, specifically p. 2779, 2ⁿᵈ col., 2780 Table 2, p.2784, 2ⁿᵈ col.).
At the time of the claimed invention, one would have had a reasonable expectation that Akkermansia in the composition would promote weight loss because the prior art teaches that the specific species of A. muciniphila is abundant in the gut mucosa in healthy subjects but is inversely correlated to body weight and significantly decreased in obese subjects. Therefore, Akkermansia and species is associated with a healthy gut mucosa and inversely correlated to obesity.
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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claim 18-25, 27-30, 49, 50, 52-55, 57-61, 63-66 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of copending Application No. 18684682 (reference application) in view of EP2103226 A1 and Derrien et al. (Frontiers in Micro., 2011, IDS) further in view of Porubcan et al. (US20120009256 A1) and Everard 2011, IDS.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claimed inventions are drawn to compositions comprising Akkermansia, a prebiotic, additional bacteria or probiotics and wherein the composition is a nutritional composition or food composition and comprise from about 1x104 cfu. Both compositions are drawn to open-ended compositions which may comprise additional ingredients. The reference claims are drawn to a pasteurized Akkermansia; however, the examined claims would not exclude a pasteurized strain.
Regarding claims 18, 23, 24, 27, 28, 30, 52, 53, 54, 59, 60, EP’226 teaches a food composition comprising probiotic bacteria (which inhabit our GI tract) including Akkermansia and further may include one or more of Lactobacillus, Bifidobacterium, Veillonella, Desemzia, Coprococcus, Collinsella, Citrobacter, Turicibacter, Sutterella, Subdoligranulum, Streptococcus, Sporobacter, Sporacetigenium, Ruminococcus, Roseburia, Proteus, Prevotella, Parabacteroides, Papillibacter, Oscillospira, Melissococcus, Dorea, Dialister, Clostridium, Cedecea, Catenibacterium, Butyrivibrio, Buttiauxella, Bulleidia, Bilophila, Bacteroides, Anaerovorax, Anaerostopes, Anaerofilum, Enterobacteriaceae, Fermicutes, Atopobium, Alistipes, Acinetobacter, Slackie, Shigella, Shewanella, Serratia, Mahella, Lachnospira, Klebsiella, Idiomarina, Fusobacterium, Faecalibacterium, Eubacterium, Enterococcus, Enterobacter, Eggerthella.
Regarding claims 18-20, the product is a liquid food, including dairy drinks, fruit juices (0010), yogurt, cheese (0019), milk (0021).
Regarding claims 21 and 22, the product is for animal and human consumption (0004).
Regarding claims 29, 49, 50, the product contains from 106 to 109 CFU (0028).
Regarding claims 57-58, 62-64, the product comprises a prebiotic including non-digestible oligosaccharides, fructo and galacto-oligosaccharides, inulin, fucose- oligosaccharides (0030).
Thus, it would have been obvious to one of ordinary skill in the art to add the additional components to an Akkermansia composition in view of EP’226.
EP’226 is silent regarding the amount of Akkermansia in the product, i.e. substantially purified Akkermansia comprises at least 50% of a strain of Akkermansia.
Derrien teach a composition comprising substantially purified A. muciniphila comprising at least 50% of the strain given that A. muciniphila is the only strain in the composition (which is administered to mice). Derrien teach the composition to comprise 109 cfu dose of A. muciniphila (p. 4, Results section). Derrien teaches that the colonization of the gut leads to gut immune homeostasis (non-inflammatory) and altered expression of genes responsible for membrane metabolism, antigen presentation of leukocytes, metabolic and signaling pathways, and lipid metabolism (p. 6, 1st and 2ⁿᵈ col.). They also teach that the mucin degrading microbe is decreased in overweight subjects as well as IBD patients and during appendicitis but is abundant in healthy subjects thus it is associated with a healthy mucosa (p. 2, last parag.-2nd col.).
The specification discloses that, the term “substantially purified” means that Akkermansia muciniphila or fragment thereof is comprised in a sample wherein it represents at least about 50%, preferably at least about 60, 70, 80, 85, 90, 95, 99% or more of the bacterial strains or fragment thereof of said sample (0047). Thus, the “substantially purified” limitation is directed to the amount of bacteria in the composition.
Thus, at the time of the claimed invention, determining the amount of Akkermansia to be in the product would have been well within the purview of one of ordinary skill in the art and one could have pursued known options within his or her technical grasp with a reasonable expectation of success.
Regarding claim 65 of the instant claims, drawn to the composition being encapsulated by a coating.
At the time of the claimed invention, encapsulating probiotic/prebiotic compositions was known, as disclosed by Porubcan, who teach probiotic/prebiotic compositions which are formulated for oral delivery and are encapsulated by an enteric coating to allow the composition to reach and be active in the intestines (0002, 0011, 0020-0022, Ex. 15, 0065).
Therefore, it would have been obvious to one of ordinary skill in the art to formulate probiotic/prebiotic compositions which have their effect in the gut/intestinal mucosa to comprise a coating allowing the composition to remain stable until it reaches the intestinal tract.
Regarding claim 66, “the amount” is not claimed, and thus, is interpreted to be any amount, which is suitable for promoting weight loss.
The intended use of the claimed composition does not patentably distinguish the composition, per se, since such undisclosed use is inherent in the reference composition. In order to be limiting, the intended use must create a structural difference between the claimed composition and the composition of the prior art. In the instant case, the intended use fails to create a structural difference, thus, the intended use is not limiting. Please note that when applicant claims a composition in terms of function, and the composition of the prior art appears to be the same, the Examiner may make rejections under both 35 U.S.C 102 and 103 (MPEP 2112). Moreover, the claimed function must be inherent to the reference composition. The discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new. Thus, the claiming of a new use, functions or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. (MPEP 2112)
Additionally, Everard teach that obesity and metabolic disorders are closely associated with a low-grade inflammatory state and that gut microbiota plays a critical role in the development of diabetes, obesity and insulin resistance. Everard study gut microbiota changes and metabolism in obese mice. They find that when obese mice are fed prebiotics, a wide shift in gut microbiota is seen and obesity and metabolic disorders are reduced and treated. Specifically, Everard see a dramatic increase in A. muciniphila in prebiotic fed obese mice compared to control mice. They teach that A. muciniphila is associated with a healthy mucosa and inversely correlated to body weight and increasing after RYGB surgical procedures (see entire document, specifically p. 2779, 2ⁿᵈ col., 2780 Table 2, p.2784, 2ⁿᵈ col.).
At the time of the claimed invention, one would have had a reasonable expectation that Akkermansia in the composition would promote weight loss because the prior art teaches that the specific species of A. muciniphila is abundant in the gut mucosa in healthy subjects but is inversely correlated to body weight and significantly decreased in obese subjects. Therefore, Akkermansia and species is associated with a healthy gut mucosa and inversely correlated to obesity.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 18-25, 27-30, 49, 50, 52-55, 57-61,63, 64 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of copending Application No. 18684681 (reference application) in view of in view of EP2103226 A1 and Derrien et al. (Frontiers in Micro., 2011, IDS) further in view of Porubcan et al. (US20120009256 A1) and Everard 2011, IDS.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claimed inventions are drawn to compositions comprising Akkermansia, a prebiotic, additional bacteria or probiotics and wherein the composition is a nutritional composition or food composition and comprise from about 1x104 cfu. Both compositions are drawn to open-ended compositions which may comprise additional ingredients. The reference claims are drawn to a pasteurized Akkermansia; however, the examined claims would not exclude a pasteurized strain.
Regarding claims 18, 23, 24, 27, 28, 30, 52, 53, 54, 59, 60, EP’226 teaches a food composition comprising probiotic bacteria (which inhabit our GI tract) including Akkermansia and further may include one or more of Lactobacillus, Bifidobacterium, Veillonella, Desemzia, Coprococcus, Collinsella, Citrobacter, Turicibacter, Sutterella, Subdoligranulum, Streptococcus, Sporobacter, Sporacetigenium, Ruminococcus, Roseburia, Proteus, Prevotella, Parabacteroides, Papillibacter, Oscillospira, Melissococcus, Dorea, Dialister, Clostridium, Cedecea, Catenibacterium, Butyrivibrio, Buttiauxella, Bulleidia, Bilophila, Bacteroides, Anaerovorax, Anaerostopes, Anaerofilum, Enterobacteriaceae, Fermicutes, Atopobium, Alistipes, Acinetobacter, Slackie, Shigella, Shewanella, Serratia, Mahella, Lachnospira, Klebsiella, Idiomarina, Fusobacterium, Faecalibacterium, Eubacterium, Enterococcus, Enterobacter, Eggerthella.
Regarding claims 18-20, the product is a liquid food, including dairy drinks, fruit juices (0010), yogurt, cheese (0019), milk (0021).
Regarding claims 21 and 22, the product is for animal and human consumption (0004).
Regarding claims 29, 49, 50, the product contains from 106 to 109 CFU (0028).
Regarding claims 57-58, 62-64, the product comprises a prebiotic including non-digestible oligosaccharides, fructo and galacto-oligosaccharides, inulin, fucose- oligosaccharides (0030).
Thus, it would have been obvious to one of ordinary skill in the art to add the additional components to an Akkermansia composition in view of EP’226.
EP’226 is silent regarding the amount of Akkermansia in the product, i.e. substantially purified Akkermansia comprises at least 50% of a strain of Akkermansia.
Derrien teach a composition comprising substantially purified A. muciniphila comprising at least 50% of the strain given that A. muciniphila is the only strain in the composition (which is administered to mice). Derrien teach the composition to comprise 109 cfu dose of A. muciniphila (p. 4, Results section). Derrien teaches that the colonization of the gut leads to gut immune homeostasis (non-inflammatory) and altered expression of genes responsible for membrane metabolism, antigen presentation of leukocytes, metabolic and signaling pathways, and lipid metabolism (p. 6, 1st and 2ⁿᵈ col.). They also teach that the mucin degrading microbe is decreased in overweight subjects as well as IBD patients and during appendicitis but is abundant in healthy subjects thus it is associated with a healthy mucosa (p. 2, last parag.-2nd col.).
The specification discloses that, the term “substantially purified” means that Akkermansia muciniphila or fragment thereof is comprised in a sample wherein it represents at least about 50%, preferably at least about 60, 70, 80, 85, 90, 95, 99% or more of the bacterial strains or fragment thereof of said sample (0047). Thus, the “substantially purified” limitation is directed to the amount of bacteria in the composition.
Thus, at the time of the claimed invention, determining the amount of Akkermansia to be in the product would have been well within the purview of one of ordinary skill in the art and one could have pursued known options within his or her technical grasp with a reasonable expectation of success.
Regarding claim 65 of the instant claims, drawn to the composition being encapsulated by a coating.
At the time of the claimed invention, encapsulating probiotic/prebiotic compositions was known, as disclosed by Porubcan, who teach probiotic/prebiotic compositions which are formulated for oral delivery and are encapsulated by an enteric coating to allow the composition to reach and be active in the intestines (0002, 0011, 0020-0022, Ex. 15, 0065).
Therefore, it would have been obvious to one of ordinary skill in the art to formulate probiotic/prebiotic compositions which have their effect in the gut/intestinal mucosa to comprise a coating allowing the composition to remain stable until it reaches the intestinal tract.
Regarding claim 66, “the amount” is not claimed, and thus, is interpreted to be any amount, which is suitable for promoting weight loss.
The intended use of the claimed composition does not patentably distinguish the composition, per se, since such undisclosed use is inherent in the reference composition. In order to be limiting, the intended use must create a structural difference between the claimed composition and the composition of the prior art. In the instant case, the intended use fails to create a structural difference, thus, the intended use is not limiting. Please note that when applicant claims a composition in terms of function, and the composition of the prior art appears to be the same, the Examiner may make rejections under both 35 U.S.C 102 and 103 (MPEP 2112). Moreover, the claimed function must be inherent to the reference composition. The discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new. Thus, the claiming of a new use, functions or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. (MPEP 2112)
Additionally, Everard teach that obesity and metabolic disorders are closely associated with a low-grade inflammatory state and that gut microbiota plays a critical role in the development of diabetes, obesity and insulin resistance. Everard study gut microbiota changes and metabolism in obese mice. They find that when obese mice are fed prebiotics, a wide shift in gut microbiota is seen and obesity and metabolic disorders are reduced and treated. Specifically, Everard see a dramatic increase in A. muciniphila in prebiotic fed obese mice compared to control mice. They teach that A. muciniphila is associated with a healthy mucosa and inversely correlated to body weight and increasing after RYGB surgical procedures (see entire document, specifically p. 2779, 2ⁿᵈ col., 2780 Table 2, p.2784, 2ⁿᵈ col.).
At the time of the claimed invention, one would have had a reasonable expectation that Akkermansia in the composition would promote weight loss because the prior art teaches that the specific species of A. muciniphila is abundant in the gut mucosa in healthy subjects but is inversely correlated to body weight and significantly decreased in obese subjects. Therefore, Akkermansia and species is associated with a healthy gut mucosa and inversely correlated to obesity.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 18-25, 27-30, 49, 50, 52-55, 57-61, 63-66 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 5-13 of copending Application No. 18035766 (reference application) in view of EP2103226 A1 and Derrien et al. (Frontiers in Micro., 2011, IDS) further in view of Porubcan et al. (US20120009256 A1) and Everard 2011, IDS.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claimed inventions are drawn to compositions comprising Akkermansia, a prebiotic, additional bacteria or probiotics and wherein the composition is a nutritional composition or food composition and comprise from about 1x104 cfu. Both compositions are drawn to open-ended compositions which may comprise additional ingredients. The reference claims are drawn to a pasteurized Akkermansia; however, the examined claims would not exclude a pasteurized strain.
Regarding claims 18, 23, 24, 27, 28, 30, 52, 53, 54, 59, 60, EP’226 teaches a food composition comprising probiotic bacteria (which inhabit our GI tract) including Akkermansia and further may include one or more of Lactobacillus, Bifidobacterium, Veillonella, Desemzia, Coprococcus, Collinsella, Citrobacter, Turicibacter, Sutterella, Subdoligranulum, Streptococcus, Sporobacter, Sporacetigenium, Ruminococcus, Roseburia, Proteus, Prevotella, Parabacteroides, Papillibacter, Oscillospira, Melissococcus, Dorea, Dialister, Clostridium, Cedecea, Catenibacterium, Butyrivibrio, Buttiauxella, Bulleidia, Bilophila, Bacteroides, Anaerovorax, Anaerostopes, Anaerofilum, Enterobacteriaceae, Fermicutes, Atopobium, Alistipes, Acinetobacter, Slackie, Shigella, Shewanella, Serratia, Mahella, Lachnospira, Klebsiella, Idiomarina, Fusobacterium, Faecalibacterium, Eubacterium, Enterococcus, Enterobacter, Eggerthella.
Regarding claims 18-20, the product is a liquid food, including dairy drinks, fruit juices (0010), yogurt, cheese (0019), milk (0021).
Regarding claims 21 and 22, the product is for animal and human consumption (0004).
Regarding claims 29, 49, 50, the product contains from 106 to 109 CFU (0028).
Regarding claims 57-58, 62-64, the product comprises a prebiotic including non-digestible oligosaccharides, fructo and galacto-oligosaccharides, inulin, fucose- oligosaccharides (0030).
Thus, it would have been obvious to one of ordinary skill in the art to add the additional components to an Akkermansia composition in view of EP’226.
EP’226 is silent regarding the amount of Akkermansia in the product, i.e. substantially purified Akkermansia comprises at least 50% of a strain of Akkermansia.
Derrien teach a composition comprising substantially purified A. muciniphila comprising at least 50% of the strain given that A. muciniphila is the only strain in the composition (which is administered to mice). Derrien teach the composition to comprise 109 cfu dose of A. muciniphila (p. 4, Results section). Derrien teaches that the colonization of the gut leads to gut immune homeostasis (non-inflammatory) and altered expression of genes responsible for membrane metabolism, antigen presentation of leukocytes, metabolic and signaling pathways, and lipid metabolism (p. 6, 1st and 2ⁿᵈ col.). They also teach that the mucin degrading microbe is decreased in overweight subjects as well as IBD patients and during appendicitis but is abundant in healthy subjects thus it is associated with a healthy mucosa (p. 2, last parag.-2nd col.).
The specification discloses that, the term “substantially purified” means that Akkermansia muciniphila or fragment thereof is comprised in a sample wherein it represents at least about 50%, preferably at least about 60, 70, 80, 85, 90, 95, 99% or more of the bacterial strains or fragment thereof of said sample (0047). Thus, the “substantially purified” limitation is directed to the amount of bacteria in the composition.
Thus, at the time of the claimed invention, determining the amount of Akkermansia to be in the product would have been well within the purview of one of ordinary skill in the art and one could have pursued known options within his or her technical grasp with a reasonable expectation of success.
Regarding claim 65 of the instant claims, drawn to the composition being encapsulated by a coating.
At the time of the claimed invention, encapsulating probiotic/prebiotic compositions was known, as disclosed by Porubcan, who teach probiotic/prebiotic compositions which are formulated for oral delivery and are encapsulated by an enteric coating to allow the composition to reach and be active in the intestines (0002, 0011, 0020-0022, Ex. 15, 0065).
Therefore, it would have been obvious to one of ordinary skill in the art to formulate probiotic/prebiotic compositions which have their effect in the gut/intestinal mucosa to comprise a coating allowing the composition to remain stable until it reaches the intestinal tract.
Regarding claim 66, “the amount” is not claimed, and thus, is interpreted to be any amount, which is suitable for promoting weight loss.
The intended use of the claimed composition does not patentably distinguish the composition, per se, since such undisclosed use is inherent in the reference composition. In order to be limiting, the intended use must create a structural difference between the claimed composition and the composition of the prior art. In the instant case, the intended use fails to create a structural difference, thus, the intended use is not limiting. Please note that when applicant claims a composition in terms of function, and the composition of the prior art appears to be the same, the Examiner may make rejections under both 35 U.S.C 102 and 103 (MPEP 2112). Moreover, the claimed function must be inherent to the reference composition. The discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new. Thus, the claiming of a new use, functions or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. (MPEP 2112)
Additionally, Everard teach that obesity and metabolic disorders are closely associated with a low-grade inflammatory state and that gut microbiota plays a critical role in the development of diabetes, obesity and insulin resistance. Everard study gut microbiota changes and metabolism in obese mice. They find that when obese mice are fed prebiotics, a wide shift in gut microbiota is seen and obesity and metabolic disorders are reduced and treated. Specifically, Everard see a dramatic increase in A. muciniphila in prebiotic fed obese mice compared to control mice. They teach that A. muciniphila is associated with a healthy mucosa and inversely correlated to body weight and increasing after RYGB surgical procedures (see entire document, specifically p. 2779, 2ⁿᵈ col., 2780 Table 2, p.2784, 2ⁿᵈ col.).
At the time of the claimed invention, one would have had a reasonable expectation that Akkermansia in the composition would promote weight loss because the prior art teaches that the specific species of A. muciniphila is abundant in the gut mucosa in healthy subjects but is inversely correlated to body weight and significantly decreased in obese subjects. Therefore, Akkermansia and species is associated with a healthy gut mucosa and inversely correlated to obesity.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments filed 12/22/2025 have been fully considered but they are not persuasive.
Regarding the objection to the specification regarding claims 58, 63, 64 and the specification not disclosing the term “non-digestible” oligosaccharide nor a glucooligosaccharide, xylooligosaccharide, an arabinogalactan, galactomannan, and/or derivatives thereof, applicant argues that the specification gives examples of non-digestible oligosaccharides and that regarding glucooligosaccharide, xylooligosaccharide, an arabinogalactan, galactomannan, and/or derivatives thereof, the specification discloses monosaccharides thereof, and since monosaccharides could readily be linked via glycosidic bonds to form oligosaccharides, the specification provides support.
The terms in the claims must find clear support or antecedent basis in the description so that the meaning of the terms in the claims may be ascertainable by reference to the description, see 37CFR 1.75(d)(1) and MPEP 608.01(o). There is no literal support for the terms in the description and just because it was known in the art that one could make oligosaccharides from monosaccharides, does not provide clear support or antecedent basis for the claimed terms.
Regarding the 101 rejection, applicants argue that the claims have been amended to include the term “prebiotic” which was not previously rejected. After further consideration the inclusion of the term “prebiotic” does not amount to significantly more and the rejection is maintained and has been amended to address the new claim limitation.
Regarding the rejection over EP226, applicants argue the intended use of the claimed composition. Applicant is reminded that claimed invention is drawn to a composition and the claims do not recite an intended use (except for new claim 66, which states that “an amount” of bacteria would be suitable to promote weight loss); however, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding the “substantially purified” limitation, the rejection has been amended to include the Derrien reference to address this limitation.
Regarding the Double patenting rejections of record applicants argue that the instant application is the earlier filed application and should issue without the need for a Terminal Disclaimer if the claims are in conditions for allowance. The rejections will be held in abeyance until allowable subject matter is indicated.
Conclusion
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/TIFFANY M GOUGH/Examiner, Art Unit 1651
/MELENIE L GORDON/Supervisory Patent Examiner, Art Unit 1651