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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 15 July 2025 has been entered.
DETAILED ACTION
Applicant’s amendment filed on 15 July 2025 is entered. Claims 23, 27, and 28 are amended, claims 33-34 are canceled, and claims 35-38 are new. Claims 23-32 and 35-38 are pending and under examination.
The previous 112(b) rejection of claims 23-32 is withdrawn in light of Applicant’s amendment.
Claim Objections
Claims 23 and 27 are objected to because of the following informalities:
Claims 23 and 27 lack articles before the terms “stomach” and “small intestine” (claim 23 ln. 8 and claim 27 ln. 7).
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 23-27 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception of a product of nature without significantly more.
The claims are directed to compositions of matter. (Step 1: Yes)
Claim 23 recites a pharmaceutical composition comprising an isolated Akkermansia muciniphila EB-AMDK19, a culture thereof, a dried powder of the isolated strain, or a dried powder of the culture; and a pharmaceutically acceptable excipient, wherein the isolated Akkermansia muciniphila EB-AMDK19, a culture thereof, a dried powder of the isolated strain, or a dried powder of the culture is enteric coated.
Akkermansia muciniphila EB-AMDK19 is a naturally occurring bacterium isolated from the feces of healthy Koreans, as evidenced by the specification (specification pg. 11 ln. 13-15).
The broadest reasonable interpretation of the dried powder of the isolated strain and dried powder of the culture of the strain includes dried powders comprising natural chemical compounds produced by the naturally occurring Akkermansia muciniphila EB-AMDK19. In the dried powders, any natural compounds produced by Akkermansia muciniphila EB-AMDK19, such as DNA, RNA, short chain fatty acids, etc., would be functionally and structurally indistinct from the natural chemical compounds themselves, and thus would not exhibit any markedly different characteristics as compared to those same compounds in nature.
The broadest reasonable interpretation of a pharmaceutically acceptable excipient includes natural compounds, such as sucrose, lactose, mannitol, glucose, and starch (specification pg. 18 lns.19-22). Sucrose, mannitol, and glucose are naturally found in Lolium perenne (perennial rye grass), as evidenced by Fig. 2 and pg. 447 para. 2 of Bocian et al. (Metabolite profiling during cold acclimation of Lolium perenne genotypes distinct in the level of frost tolerance, J Appl Genetics (2015) 56:439–449). Lactose is naturally found in milk. Starch is naturally found in corn and potatoes.
The broadest reasonable interpretation of enteric coating includes coatings comprising naturally occurring compounds, such as alginate, pectin, glyceride, and glycerol monostearate, as evidenced by the abstract of Khoder et al. (A novel natural GRAS-grade enteric coating for pharmaceutical and nutraceutical products, International Journal of Pharmaceutics 584 (2020) 119392).
Claim 24 recites that Akkermansia muciniphila EB-AMDK19 comprises a 16s rRNA gene of SEQ ID NO: 1. Since Akkermansia muciniphila EB-AMDK19 is a naturally occurring bacteria as discussed above, the 16s rRNA gene that the strain comprises is also naturally occurring.
Claim 25 recites that the composition contains Akkermansia muciniphila EB-AMDK19 in probiotic form or a pasteurized form. The specification does not provide a specific definition for the term “probiotic” so the art recognized definition “live microorganisms that provide health benefits to their host” is applied. Since Akkermansia muciniphila EB-AMDK19 is a naturally occurring bacteria, the probiotic form of Akkermansia muciniphila EB-AMDK19 is simply the living Akkermansia muciniphila EB-AMDK19 cells themselves. The specification describes pasteurization as heating Akkermansia muciniphila EB-AMDK19 at a temperature equal to or higher than 50°C and lower than 100°C for 10 minutes or more (specification pg. 14 lns. **). Although the specification never explicitly states so, the art recognized definition of pasteurization means that the bacteria cells present in the pasteurized composition are killed. Since Akkermansia muciniphila EB-AMDK19 is a naturally occurring bacteria, any of the residual cell components or chemical compounds produced by or present in the now dead bacterial cells are also naturally occurring materials.
Claim 26 recites the composition comprises Akkermansia muciniphila EB-AMDK19 at a concentration of 108 to 1012 CFU/g. Since Akkermansia muciniphila EB-AMDK19 is a naturally occurring bacteria, any given concentration of Akkermansia muciniphila EB-AMDK19 would still be naturally occurring.
Claim 27 recites a food composition comprising an isolated Akkermansia muciniphila EB-AMDK19, a culture thereof, a dried powder of the isolated strain, or a dried powder of the culture; and a carrier or an excipient, wherein the isolated Akkermansia muciniphila EB-AMDK19, a culture thereof, a dried powder of the isolated strain, or a dried powder of the culture is enteric coated.
Akkermansia muciniphila EB-AMDK19 is a naturally occurring bacteria isolated from the feces of healthy Koreans, as evidenced by the specification (specification pg. 11 ln. 13-15).
The broadest reasonable interpretation of the dried powder of the isolated strain and dried powder of the culture of the strain includes dried powders comprising natural chemical compounds produced by the naturally occurring Akkermansia muciniphila EB-AMDK19. In the dried powders, any natural compounds produced by Akkermansia muciniphila EB-AMDK19, such as DNA, RNA, short chain fatty acids, etc., would be functionally and structurally indistinct from the natural chemical compounds themselves, and thus would not exhibit any markedly different characteristics as compared to those same compounds in nature.
The broadest reasonable interpretation of an excipient includes natural compounds, such as sucrose, lactose, mannitol, glucose, and starch (specification pg. 18 lns.19-22). Sucrose, mannitol, and glucose are naturally found in Lolium perenne (perennial rye grass), as evidenced by Fig. 2 and pg. 447 para. 2 of Bocian et al. (Metabolite profiling during cold acclimation of Lolium perenne genotypes distinct in the level of frost tolerance, J Appl Genetics (2015) 56:439–449). Lactose is naturally found in milk. Starch is naturally found in corn and potatoes.
The broadest reasonable interpretation of enteric coating includes coatings comprising naturally occurring compounds, such as alginate, pectin, glyceride, and glycerol monostearate, as evidenced by the abstract of Khoder et al. (A novel natural GRAS-grade enteric coating for pharmaceutical and nutraceutical products, International Journal of Pharmaceutics 584 (2020) 119392).
Therefore, the claimed nature-based products recite a judicial exception of a product of nature. (Step 2A Prong one: Yes)
Applicant may consider amending claim 23 and 27 to include the contents of claims 35-38 to obviate this rejection because the coating agents recited in claims 35-38 are non-naturally occurring.
This judicial exception is not integrated into a practical application, nor does it include additional elements that are sufficient to amount to significantly more than the judicial exception, because the claims included in this rejection are only drawn to the compositions comprising the natural bacteria and their produced chemical compounds, and thus are not integrated into a practical application. The product of nature is not an improvement to technology or a technical field, a particular treatment or prophylaxis for a disease, or a transformation or reduction of a particular article to a different state or thing. Claims’ 23 and 27 limitation that the pharmaceutical and food compositions “can pass through stomach and reach small intestine in which the isolated Akkermansia muciniphila EB-AMDK19 strain, the culture thereof, the dried powder of the isolated strain, or the dried powder of the culture are released” merely describes an inherent capability of the naturally occurring pharmaceutical and food compositions, but does not apply the compositions for any given purpose. (Step 2A Prong two and Step 2B: No)
Accordingly, the claims do not constitute patent eligible subject matter under 35 U.S.C. § 101.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 23-32 and 35-38 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 23, 27, and 28, it is unclear whether the parenthetical phrase, accession number KCTC 13761BP, is part of the claim limitations and intended to be limiting, or if the contents inside the parentheses are merely exemplary and thus not required.
Claim 27 recites the limitation "the pharmaceutical composition" in line 7 of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claims 24-26 and 35-36 are dependent on claim 23, claims 37-38 are dependent on claim 27, and claims 29-32 are dependent on claim 28, so those dependent claims are indefinite for the same reasons.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 23-27 and 35-38 are rejected under 35 U.S.C. 103 as being unpatentable over Cani et al. (US 20150306152 A, published October 2015) in view of Pyar et al. (Enteric coating of granules containing the probiotic Lactobacillus acidophilus, Acta Pharm. 64 (2014) 247–256), as evidenced by Sequence Search Results (Filed 12 October 2023 in the Image File Wrapper (IFW)) and Evonik (EUDRAGIT® L 30 D-55, Evonik Industries AG, May 2014).
Regarding claims 23 and 27, the limitation “wherein the pharmaceutical composition can pass through stomach and reach small intestine in which the isolated Akkermansia muciniphila EB-AMDK19 strain, the culture thereof, the dried powder of the isolated strain, or the dried powder of the culture thereof are released” recites a functional ability of the claimed compositions, but this limitation does not add any new structural elements to the claimed compositions; thus, if a composition in the prior art teaches all of the structural limitations of the claimed composition, this limitation is rendered obvious.
Regarding claims 23-25 and 27, Cani teaches a pharmaceutical or food composition comprising viable probiotic Akkermansia muciniphila or fragments thereof and excipients, carriers, and coatings (Cani [0103]-[0104]).
Cani does not teach that the Akkermansia muciniphila is enteric coated.
Pyar teaches an enteric coating on a probiotic Lactobacillus acidophilus (Pyar Abstract). Pyar teaches that enteric coating protect probiotics from harmful effects of gastric acidity and ensure their viability and safe release at the intestinal target (Pyar pg. 248 para. 2).
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the present invention to modify Cani’s pharmaceutical and food compositions by enterically coating their probiotic Akkermansia muciniphila, as suggested by Pyar. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success in order to protect the probiotic Akkermansia muciniphila from the harmful effects of gastric acidity and ensure their viability and safe release at the intestinal target.
However, Cani does not teach that the Akkermansia muciniphila is strain EB-AMDK19 with a 16s rRNA gene of SEQ ID NO: 1.
Since Cani teaches that compositions comprising Akkermansia muciniphila can be used to treat identical metabolic diseases as those of the instant claims (Cani claims 1 and 19-21), the different strains of Akkermansia muciniphila encompassed by Cani’s disclosure are not significantly functionally different from the Akkermansia muciniphila strain EB-AMDK19 of the present invention, absent of evidence to the contrary. Additionally, the 16s rRNA gene of Akkermansia muciniphila strain EB-AMDK19 (SEQ ID NO: 1) aligns with >99% similarity to a large amount of Akkermansia muciniphila species, as evidenced the Sequence Search Results (IFW). Thus, Akkermansia muciniphila strain EB-AMDK19 would be expected by one of ordinary skill in the art to be functionally equivalent to the species of Akkermansia muciniphila as disclosed by Cani.
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the present invention to modify Cani’s pharmaceutical and food compositions to comprise any strain of Akkermansia muciniphila that has the same functional health properties as the Akkermansia muciniphila taught by Cani. Since the Akkermansia muciniphila EB-AMDK19 strain of the present invention has the same functional health properties as the Akkermansia muciniphila taught by Cani, one of ordinary skill in the art would have found it prima facie obvious to modify Cani’s pharmaceutical and food compositions to comprise Akkermansia muciniphila EB-AMDK19.
Regarding claim 26, Cani teaches the amount of Akkermansia muciniphila in the composition ranges from 102 to 1015 cfu (Cani [0054]).
Regarding claims 35 and 37, Pyar teaches the polymer used to enterically coat the probiotic Lactobacillus is Eudragit L30D-55 (Pyar Abstract), which is an ethyl acrylate-methacrylic acid copolymer, as evidenced by Evonik (Evonik pg. 1).
Regarding claims 36 and 38, Cani teaches their pharmaceutical and food compositions comprise polyethylene glycol (PEG), methylcellulose, and hydroxypropyl methylcellulose (Cani [0099]-[0103]).
Claims 28-30 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Cani et al. (US 20150306152 A, published October 2015) as evidenced by Sequence Search Results (Filed 12 October 2023 in the Image File Wrapper (IFW))
Regarding claims 28-30, Cani teaches methods of treating metabolic disorders such as obesity (reducing body weight), insulin-resistance, dyslipidemia, and inflammatory and immune disorders in a subject by administering a composition comprising viable probiotic Akkermansia muciniphila bacteria or fragments thereof to a subject in need thereof (Cani claims 18 and 19-21).
Regarding claim 32, Cani teaches the Akkermansia muciniphila is administered in an amount ranging from 104 to 1012 cfu (Cani claim 23).
However, Cani does not teach that the Akkermansia muciniphila is strain EB-AMDK19 with a 16s rRNA gene of SEQ ID NO: 1.
Since Cani teaches that compositions comprising Akkermansia muciniphila can be used to treat identical metabolic diseases as those of the instant claims (Cani claims 1 and 19-21), the different strains of Akkermansia muciniphila encompassed by Cani’s disclosure are not significantly functionally different from the Akkermansia muciniphila strain EB-AMDK19 of the present invention, absent of evidence to the contrary. Additionally, the 16s rRNA gene of Akkermansia muciniphila strain EB-AMDK19 (SEQ ID NO: 1) aligns with >99% similarity to a large amount of Akkermansia muciniphila species, as evidenced the Sequence Search Results (IFW). Thus, Akkermansia muciniphila strain EB-AMDK19 would be expected by one of ordinary skill in the art to be functionally equivalent to the species of Akkermansia muciniphila as disclosed by Cani.
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the present invention to modify Cani’s methods of treating metabolic disorders such as obesity (reducing body weight), insulin-resistance, dyslipidemia, and inflammatory and immune disorders by administering a composition comprising viable cells of any strain of Akkermansia muciniphila or fragments thereof that have the same functional health properties as the Akkermansia muciniphila taught by Cani. Since the Akkermansia muciniphila EB-AMDK19 strain of the present invention has the same functional health properties as the Akkermansia muciniphila taught by Cani, one of ordinary skill in the art would have found it prima facie obvious to modify Cani’s methods to administer compositions comprising viable Akkermansia muciniphila EB-AMDK19 cells or fragments thereof.
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Cani as applied to claims 28-30 and 32 above, and further in view of O’Mahony et al. (WO 2017060698 A1, published 13 April 2017).
Cani does not teach their methods treat the specific gastrointestinal inflammatory diseases inflammatory bowel disease (IBD), Crohn's disease, ulcerative colitis, intestinal Behcet's disease, radiation enteritis, or ischemic enteritis.
O’Mahony teaches that compositions comprising Akkermansia muciniphila can be used to treat gastrointestinal inflammatory conditions like inflammatory bowel disease, Crohn’s disease, and ulcerative colitis (O’Mahony claim 11).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the present invention to modify Cani’s method of treating inflammatory disorders/diseases to treat the specific gastrointestinal inflammatory diseases inflammatory bowel disease, Crohn’s disease, and ulcerative colitis by administering Akkermansia muciniphila EB-AMDK19. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success because O’Mahony teaches that compositions comprising Akkermansia muciniphila are useful for treating inflammatory bowel disease, Crohn’s disease, and ulcerative colitis.
Response to Arguments
Applicant's arguments and Dr. Lee Declaration, both filed 15 July 2025, have been fully considered but they are not persuasive.
Regarding Applicant’s arguments that enteric coated compositions do not occur in nature and furthermore provide the markedly different benefit of allowing the composition to pass through the stomach and release in the small intestine, and that present claims may be compared to the amazonic acid example from claim 5 of Example 3 for the nature-based products provided in the Subject Matter Eligibility Examination Guidance, thus the enteric coating of the present invention confers different functional characteristics than the natural occurring product (Remarks pgs. 7-9), example 11 claim 5 of the Subject Matter Eligibility Examination Guidance issued by the USPTO provides the amazonic acid example. Within that example, it is shown that “Applicants disclose an example of a solid pharmaceutical composition demonstrating that when a core of amazonic acid is enveloped by a layer of a natural polymeric material, the resulting manufacture does not release the amazonic acid until it reaches the colon. This colonic release greatly improves the bioavailability of amazonic acid, and is particularly advantageous in the treatment of colon cancer”. Thus, a working example and/or data was provided by the Applicants in the example’s specification that showed the markedly different characteristic of the amazonic acid not being released until it reaches the colon, which greatly improved the bioavailability of amazonic acid.
However, the instant invention does not have any comparable working examples or data. Huyghebaert et al. (In vitro evaluation of coating polymers for enteric coating and human ileal targeting, International Journal of Pharmaceutics 298 (2005) 26–37) shows that there is a large amount of unpredictability in the effectiveness of enteric coating protection of a composition in acidic gastric juices and release in the intestines. Huyghebaert tested different enteric coating materials with a composition comprising thymidine, which will be eventually co-formulated with Lactococcus lactis upon demonstration of enteric coating success (Huyghebaert pg. 27 para. 3). Huyghebaert states that “the release of thymidine in HCl 0.1N gives a good indication of the acid permeability of the enteric-coating during passage through the stomach and the possible detrimental effect on L. lactis’ viability” (Huyghebaert Pg. 31 para. 1 last sent.), and that the enteric coating polymer must dissolve from pH 6.8 to allow complete release within 40 minutes (Huyghebaert abstract). Huyghebaert figure 1 shows a large degree of variability in the success of enteric coating in simulated gastric juices, some coatings prematurely released thymidine in the 0.1N HCl (indicating enteric coating failure through gastric juices) and other coatings did not release thymidine in the 0.1N HCl (indicating enteric coating success through gastric juices). Huyghebaert figures 3-4 and 7 show the long length of times required for the different tested enteric coatings at different pH, especially pH 6.8, since release into the small intestine requires that the enteric coating polymer must dissolve from pH 6.8 to allow complete release within 40 minutes (Huyghebaert abstract). None of the tested enteric coatings completely released their payload within 40 minutes, as shown in figure 3-4 and 7. Huyghebaert concludes that none of the tested polymers/mixtures ensured enteric properties and ileal targeting (Huyghebaert abstract).
Therefore, in view of Huyghebaert, it cannot be reasonably assumed with confidence beyond a reasonable doubt that the qualities that Applicant alleges enteric coating provides to the instant composition as compared to its natural counterpart add markedly different characteristics. The amazonic acid example cannot be reasonably extended to be applicable to the instant invention without sufficient working examples or data to support that the enteric coating as claimed provides markedly different characteristics as compared to its natural counterpart.
Regarding Applicant’s arguments that Cani does not disclose Akkermansia muciniphila strain EB-AMDK19 and nothing within Cani would have guided one of ordinary skill in the art to select Akkermansia muciniphila EB-AMDK19, and the Declaration by Dr. Lee filed on 15 July 2025 demonstrates clear and significant functional differences among the different Akkermansia muciniphila strains as compared to Akkermansia muciniphila EB-AMDK19, which shows the strongest suppressive effect on lipid accumulation in adipocytes and enhances GLP-1 secretion most potently, which are surprising results that could not have been expected from the disclosure of Cani (Remarks pgs. 10-11), Applicant’s comparison of multiple different strains of Akkermansia muciniphila to the claimed Akkermansia muciniphila EB-AMDK19 strain as presented in the Declaration by Dr. Lee filed 15 July 2025 appears to demonstrate some variability between the different strains of Akkermansia muciniphila, and that instant strain Akkermansia muciniphila EB-AMDK19 has some advantageous effects as compared to the other Akkermansia muciniphila strains. However, the declaration is limited to only showing these differentiating results with regards to lipid accumulation in adipocytes and GLP-1 secretions. The scope of the claims is broader than just treating dyslipidemia and increasing secretion of GLP-1.
For example, no data has been made of record which shows any unexpected superiority of Akkermansia muciniphila EB-AMDK19 over other strains of Akkermansia muciniphila with regards to insulin resistance. Instant fig. 12A does not appear to show significantly different results between instant strain EB-AMDK19 and any other strain. The two bars showing insulin concentration of instant strain EB-AMDK19 and prior art strain BAA-835 appear to overlap, and there is no indication that the insulin concentrations of the two strains are significantly different from one another, but rather that both strains are significantly different from the control. Fig. 12B appears to show a minor difference between instant strain EB-AMDK19 and prior art strain BAA-835 in HOMA-IR scores, however the two bars are very close to one another, and there is no indication that the HOMA-IR scores of the two strains are significantly different from one another, but rather that both strains are significantly different from the control’s HOMA-IR score. As such, there is no evidence of unexpected results between instant strain EB-AMDK19 and any other strain of Akkermansia muciniphila with regards to treating insulin resistance. Additionally, Cani’s disclosure is broader than just strain BAA-835 which Applicant has compared with the instant strain EB-AMDK19. Even if Applicant demonstrates unexpected results as compared to BAA-835, those unexpected results cannot necessarily be extended to all Akkermansia muciniphila strains (which Cani’s disclosure teaches) without adequate evidence to the contrary. MPEP §716.01(b) states “[t]he weight attached to evidence of secondary considerations by the examiner will depend upon its relevance to the issue of obviousness and the amount and nature of the evidence”. The amount and nature of evidence presented by Applicant to demonstrate unexpected results over the prior art is insufficient to overcome the prima facie case of obviousness.
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