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 5/18/2026 has been received and entered into the case. Claims 18-30, 48-55, 57-61, 63-65 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.
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 “and/or any derivatives thereof” according to claims 58, 63, and 64. It is suggested applicant delete the terms “non-digestible oligosaccharide” and “and/or any derivatives thereof” to overcome this objection.
Appropriate correction is required.
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, 57-61, 63, 64, 65 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” and “effective amount” limitations do 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 term “effective amount” also does not markedly change characteristics of either component because each component continues to have the same characteristics and the bacteria has the same properties as it has alone, and the combination does not provide a marked difference in functional characteristics as compared to the natural counterparts. The claims encompass amounts of a 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, 65 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) and Everard 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) and is therefore taken to be an effective amount “suitable for promoting weight loss in a subject” as it falls within applicants claimed range.
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.
Regarding claims 57-58, 62-64, EP’226 teaches the product to comprise 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.
Claim 65 is 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).
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.
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, 63-65 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).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claimed inventions are drawn to (food or nutritional) 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 to 1x1012 cfu, therefore taken to be an effective amount suitable for promoting weight loss. 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, 55, 59, 60, 61, 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 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.
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 5/18/2025 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, and/or derivatives thereof, applicant argues that the specification provides multiple representative non-digestible oligosaccharides representative of the genus.
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 the specification does not provide for derivatives thereof.
Regarding the 101 rejection, applicants argue that the claims have been amended to include the term “effective amount…wherein the effective amount is suitable for promoting weight loss” which improves technology by promoting weight loss and thus, integrating the concept into a practical application and the composition having markedly different characteristics from a natural product. Applicants’ recitation of an “effective amount” having an intended use in the product claim, does not indicate that the mixture of the components changes the structure and function of the mixture. The mixture does not change the functional property so that the resultant mixture has an enhanced function different than the mere “sum” of the individual components. The mixture does not have a marked difference in functional characteristics as compared to the natural counterparts, i.e. the prebiotics and the probiotic Akkermansia each retain their naturally occurring structure and properties.
Regarding the rejection over EP226 and Derrien, applicants argue the intended use of the claimed composition.
Applicant is reminded that claimed invention is drawn to a composition having an intended use , i.e. “wherein the effective amount is 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.
Additionally, while independent claims do not claim a specific “effective amount”, dependent claims 29, 49, 50 claim a range of about 1x104 to 1x1012 cfu Akkermansia, which EP’226 teaches their product contains from 106 to 109 CFU of the probiotic bacteria. Therefore, the art teaches a composition having an effective amount, which falls within applicants claimed range of an effective amount “that would be suitable for promoting weight loss”.
Applicants argue that the Office has not established why a posita would be motivated to combine the references. Applicants address EP226’s disclosure of a long-life food product containing probiotics preservable and stored for an extended period of time. Applicants argue that one would have no reason to select Akkermansia over other conventional probiotics capable of surviving in the dormant state.
Applicants additionally argue that the reference includes that the composition can comprise additional microbes and Akkermansia would be selected from a laundry list of microbes. Additionally, applicants argue that the reference is silent regarding the “substantially purified Akkermansia comprising at least 50% of a strain of Akkermansia”.
Applicants define substantially purified as “As used herein, 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 5 strains or fragment thereof of said sample”.
It is the Examiners position that EP’226 teaches a food product for consumption comprising a probiotic strain which is a natural gut inhabitant selected from Akkermansia (0012, for example) with a prebiotic. The product is not limited to a spore or dormant product, the reference teaches that a spore or non-spore product is contemplated (0014).
Derrien teaches administering a composition solely containing Akkermansia, which is inversely correlated to body weight and significantly decreased in obese subjects.
At the time of the claimed invention, compositions comprising natural gut inhabitants including Akkermansia formulated together with a prebiotic and encapsulated for oral delivery were known in the art. Further, Everard and Derrien teach that Akkermansia is inversely correlated to obesity and thus, 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.
Regarding Derrien, applicant argues that “The Office Action points to Derrien's disclosure referencing Akkermansia as being, "decreased in overweight subjects as well as IBD patients and during appendicitis but is abundant in healthy subjects," Office Action as page 12. However, these references amount to a disconnected assortment of unrelated physiological associations (e.g., overweight, appendicitis, and IBD) without establishing any mechanistic connection, therapeutic implication, or predictable outcome to arrive at the claimed compositions…Derrien exclusive use of germ-free mice…precludes any reasonable expectation of success that results in a mono-association would translate to probiotic efficacy in conventional hosts. Derrien notes that “conventional mice, "no bacteria were present in the proximal mucus layer mainly consisting of Muc2," but in a germ-free background A. muciniphila can colonize the inner mucus layer because in conventionalized mice, "it has to compete with other bacteria." Derrien at page 13, left column. As such, in Derrien's GF mono-association system, Akkermansia localization, competition dynamics, and functional behavior differ fundamentally between germ-free and conventional microbiota contexts, and therefore Derrien does not inform compositions comprising an effective amount of a substantially purified Akkermansia suitable for promoting weight loss in a subject as required by the subject claims.
Regarding Everard, applicants argue that Everard is related to administering prebiotics and identifying modulation of gut bacterial communities in obese and diabetic mice and notices shift across 102 distinct taxa, thus, suggesting community-wide modulation.
It is the Examiners position that Derrien teaches that the mouse model system is used to gain a better understanding of the intestinal microbiota and that their data shows that colonization of germ-free mouse intestines leads to balanced immune responses for Akkermansia and towards promotion of lipid metabolism. The section referenced by applicants at p. 13 of Derrien is related to a different study, not that of Derrien. Derrien teaches that administration and colonization of Akkermansia leads to expression of genes involving metabolic homeostasis and lipid metabolism. Applicant’s arguments regarding conventional hosts is not commensurate in scope as the claims are drawn to a composition.
Everard is relied upon for teaching that gut microbiota is known to play a role in obesity, diabetes and insulin resistance. Prebiotics are known to beneficially affect host health by selectively stimulating the growth of gut microbes. Obese mice fed prebiotics had an abundant shift in Akkermansia muciniphila (p. 2779, 2nd col., and Table 2). Prebiotics also improved glucose and lipid metabolism in obese mice as well as a decrease in fat mass and good intake with an increase in muscle mass.
Therefore, the art teaches a correlation between Akkermansia as well as prebiotic with Akkermansia abundance in healthy versus obese subjects’ and thus, one would have been motivated to make the claimed composition comprising Akkermansia with a reasonable expectation of promoting weight loss.
Regarding the Double patenting rejection 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.
It should be noted that the ODP rejections over 18684681 and 18684682 are withdrawn in light of applicants claim amendments in these pending applications.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIFFANY MAUREEN GOUGH whose telephone number is (571)272-0697. The examiner can normally be reached M-Thu 8-5.
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/TIFFANY M GOUGH/ Examiner, Art Unit 1651
/MELENIE L GORDON/Supervisory Patent Examiner, Art Unit 1651
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