DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicants’ Amendments
1) Acknowledgment is made of Applicants’ amendments filed 03/30/26 and 01/21/26 in response to the non-final Office Action mailed 07/22/25.
Status of Claims
2) Claims 1-15 have been amended via the amendment filed 03/30/2026.
New claims 16-27 have been added via the amendment filed 03/30/2026.
Claims 1-27 are pending and are under examination.
Information Disclosure Statements
3) Acknowledgment is made of Applicants’ Information Disclosure Statements 03/13/26, 12/22/25 and 03/13/26. The information referred to therein has been considered and a signed copy is attached to this Office Action.
Substitute Specification
4) Acknowledgment is made of Applicants’ substitute specification filed 03/30/26. Said substitution is objected to because it is non-compliant under Patent Rule § 41.106 (a) (2) (ii) because of improper single-spaced lines. The spacing of the lines of the substitute specification is such as to make reading and examination difficult. A substitute specification with lines 1.5 or double spaced is required. See Patent Rules § 41.106 (a) (2) (ii) and MPEP Chapter 600.
Prior Citation of Title 35 Sections
5) The text of those sections of Title 35 U.S. code not included in this action can be found in a prior Office Action.
Prior Citation of References
6) The references cited or used as prior art in support of one or more rejections in the instant Office Action and not included on an attached form PTO-892 or form PTO-1449 have been previously cited and made of record.
Objection(s) Withdrawn
7) The objections to the specification set forth at paragraphs 5(a) and 5(b) of the Office Action mailed 07/22/25 are withdrawn in light of Applicants’ amendments to the specification.
8) The objections to claims 14 and 15 set forth in paragraph 12 of the Office Action mailed 07/22/25 are withdrawn in light of Applicants’ claim amendments.
Objection(s) to Claims and/or Specification
9) New claims 9, 20 and 21 are objected to for the following reasons:
35 U.S.C § 132 states that no amendment shall introduce new matter into the disclosure of the invention. 37 CFR 1.75(d)(1) provides, in part, that ‘the terms and phrases used 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.’
New claims 20 and 21 and claim 9, as amended, set forth below, include limitations indicated below in bold, which limitations lack antecedent basis and descriptive support in the as-filed specification:
20. (New) The method of claim 3, wherein the Akkermansia muciniphila is present in the composition in an amount of from 1.104 to 1.1012 cells, from 1.105 cells to 1.1011 cells, or from 1.106 to 1.1010 cells.
21. (New) The method of claim 15, wherein the Akkermansia muciniphila is present in the composition in an amount of from 1.104 to 1.1012 cells, from 1.105 cells to 1.1011 cells, or from 1.106 to 1.1010 cells.
9. (Currently Amended) The composition of claim [[1]]2, wherein the pasteurized Akkermansia muciniphila is present in the composition in an amount of from 1.104 to 1.1012 cells per day, more preferably from 1.105 cells to 1.1011 cells to 1.1011 cells or from 1.106 to 1.1010 cells
Appropriate correction to the specification is needed.
Rejection(s) Withdrawn
10) The rejection of claims 2-13 set forth in paragraph 7(a) Office Action mailed 07/22/25 under 35 U.S.C § 112(b) or pre-AIA , second paragraph, as being indefinite, is withdrawn in light of Applicants’ claim amendments.
11) The rejection of claim 2 set forth in paragraph 7(b) Office Action mailed 07/22/25 under 35 U.S.C § 112(b) or pre-AIA , second paragraph, as being indefinite, is withdrawn in light of Applicants’ claim amendment.
12) The rejection of claim 5 set forth in paragraph 7(c) Office Action mailed 07/22/25 under 35 U.S.C § 112(b) or pre-AIA , second paragraph, as being indefinite, is withdrawn in light of Applicants’ amendments to the claim requiring a new rejection as set forth in this Office Action.
13) The rejection of claims 8-10 set forth in paragraph 7(d) Office Action mailed 07/22/25 under 35 U.S.C § 112(b) or pre-AIA , second paragraph, as being indefinite, is withdrawn in light of Applicants’ claim amendments.
14) The rejection of claims 9-10 set forth in paragraph 7(e) Office Action mailed 07/22/25 under 35 U.S.C § 112(b) or pre-AIA , second paragraph, as being indefinite, is withdrawn in light of Applicants’ claim amendments.
15) The rejections of claim 13 set forth in paragraphs 7(f) and 7(g) Office Action mailed 07/22/25 under 35 U.S.C § 112(b) or pre-AIA , second paragraph, as being indefinite, are withdrawn in light of Applicants’ claim amendment.
16) The rejections of claim 14 set forth in paragraphs 7(h), 7(i) and 7(j) Office Action mailed 07/22/25 under 35 U.S.C § 112(b) or pre-AIA , second paragraph, as being indefinite, is withdrawn in light of Applicants’ claim amendments.
Rejection(s) under 35 U.S.C § 103 Maintained
17) The rejection of claims 1, 3, 4, 7-11 and 15 set forth in paragraph 9 Office Action mailed 07/22/25 under 35 U.S.C § 103 as being unpatentable over Sheng et al. (The FASEB J. 32: 6371-6384, December 2018, of record) as evidenced by the document Teavigoâ ((Green Tea Extract, EGCG), NutriScience Innovations, LLC, pages 1-3, No publication date, of record) is maintained.
New claims 20-27 are now added to this rejection.
Applicants contend that they have surprisingly discovered that the composition of the subject claims comprising Akkermansia muciniphila and green tea extract has synergistic properties. Applicants refer to Figures 1-3 and 5 and paragraph [0109] of the specification and
state that they have discovered that the combination of green tea extract and Akkermansia muciniphila showed superior results on weight loss, reduction of weight gain and improved gut barrier function. Applicants submit that body weight gain was significantly lower for the combination of Akkermansia muciniphila and green tea extract than with Akkermansia muciniphila alone. Applicants assert that the results achieved by Applicants showed that a synergistic result could be achieved when combining green tea extract and Akkermansia muciniphila. Applicants refer to FIG. 1B and paragraph [0014] of the specification and submit that using mice fed a high fat diet (HFD), Applicants demonstrated that after one week of treatment, the combination of Akkermansia muciniphila and green tea extract showed increased efficacy with a significantly lowered body weight gain compared to single-agent treatment (1.24 g reduction in the combination vs. 0.36 and 0.44 g reduction in the Akkermansia muciniphila and green tea extract group, respectively, p<0.05). Applicants assert that this effect was indeed synergistic as the combination of Akkermansia muciniphila and green tea extract achieved more of an effect than the sum of their parts. Applicants assert that Sheng’s abstract discloses a study on the effects of epigallocatechin-3-gallate (EGCG) on diet-induced obesity, but fails to disclose or discuss each and every element of the subject claims. Applicants state that in contrast to Applicants' surprising discovery, Sheng determined that EGCG and Akkermansia muciniphila were equally effective in treating diet-induced obesity. Applicants conclude that nowhere did Sheng disclose the unexpected results shown by Applicants.
Applicants’ arguments have been carefully considered, but are deemed non-persuasive.
First, with regard to Applicant’s reference to paragraphs [0109] and [014] of the specification, there are no such paragraphs in the instant specification. Second, the asserted surprising synergistic properties are limited to an oral composition comprising a specific number, i.e., 2.108 TFU per day of pasteurized Akkermansia muciniphila and a specific amount, i.e., 300 mg of green tea extract administered orally for 12 weeks and a method of oral administration of said composition, wherein the synergistic observations are limited to promotion of body weight loss and gut barrier function. For example, see pages 16-17 of the original specification and Figures 1-3 and 5. Note that the Akkermansia muciniphila comprised in the composition of the amended claim 1 is not required to be pasteurized. The claimed composition is not required to be a synergistic combination of the two recited elements present in specific amounts or doses sufficient to exert said synergistic effects. The asserted unexpected results must be due to the claimed features, not to unclaimed features. The feature(s) upon which Applicants rely is not a part of the currently rejected claims. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). The Office maintains that the prior art reference, as a whole, renders obvious the instantly claimed invention.
With regard to Applicants’ remark on the evidentiary reference of Teavigo that it is not prior art to the subject application, it must be noted that the critical date of extrinsic evidence need not antedate the filing date. See MPEP 2124. Additionally, other evidentiary references other than Teavigo have also taught that the Teavigo product is indeed the Green Tea Extract, EGCG. For example:
Wolfram et al. Annals of Nutrition & Metabolism 49(1): 54-63, pages 1-2, 2005 taught that TEAVIGO is Green Tea Extract, EGCG in a pure form, and that its supplementation prevented diet-induced obesity in mice, decreased subcutaneous and epididymal adipose tissue weights, reversed the established obesity, and markedly decreased fatty acid synthase acetyl-CoA carboxylase-1 mRNA levels in adipose tissue of EGCG-supplemented mice. See page 1.
Likewise, Klaus et al. International J. Obesity 29(6): 615-623, 2005 taught that EGCG purified from green tea is TEAVIGO, the dietary supplementation which resulted in a dose-dependent attenuation of body fat accumulation, reduced food digestibility, and reduced long-term energy absorption. See page 1.
18) The rejection of claims 2, 5 and 11 set forth in paragraph 10 of the Office Action mailed 07/22/25 under 35 U.S.C § 103 as being unpatentable over Sheng et al. (The FASEB J. 32: 6371-6384, December 2018, of record) as evidenced by the document Teavigoâ (Green Tea Extract, EGCG, of record), NutriScience Innovations, LLC, pages 1-3, No publication date, of record) as modified and as applied to claim 1 above and further in view of WO 2017/042347 A1 (of record) is maintained.
Applicants submit that Sheng and Cani, alone or in combination, fail to disclose Applicants' synergistic combination of Akkermansia and green tea extract. Applicants contend that Cani is silent regarding the combination of green tea extract with Akkermansia and Teavigo, which Applicants do not concede is prior art, also fails to provide a disclosure of a synergistic combination of Akkermansia and green tea extract.
Applicants’ arguments have been carefully considered, but are not persuasive.
Applicants are referred to the paragraph supra for the Office’s rebuttal of Applicants’ arguments on the teachings of Sheng et al. as evidenced by the Teavigoâ document. If WO 2017/042347 A1 taught the combination of green tea extract with Akkermansia, it would have been applied as an anticipatory art.
19) The rejection of claim 12 set forth in paragraph 11 of the Office Action mailed 07/22/25 under 35 U.S.C § 103 as being unpatentable over Sheng et al. (The FASEB J. 32: 6371-6384, December 2018, of record) as evidenced by the document Teavigoâ ((Green Tea Extract, EGCG, of record), NutriScience Innovations, LLC, pages 1-3, No publication date, of record) as modified and as applied to claim 1 above and further in view of Uchiyama et al. (Nutrition 27: 287-292, 2011, of record) is maintained.
Applicants submit that Sheng and Uchiyama, alone or in combination, fail to disclose Applicants' synergistic combination of Akkermansia and green tea extract. Applicants contend that Teavigo, which Applicants do not concede is prior art, also fails to provide a disclosure of a synergistic combination of Akkermansia and green tea extract.
Applicants’ arguments have been carefully considered, but are not persuasive.
Applicants are referred to the paragraph supra for the Office’s rebuttal on Applicants’ arguments on Sheng’s teachings and Applicants’ remark on the Teavigoâ. The teachings of Sheng et al. as modified by the teachings of Uchiyama et al. render obvious the composition of the amended claim 12.
Rejection(s) under 35 U.S.C § 112(a) or (Pre-AIA ), First Paragraph
20) The following is a quotation 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 35 U.S.C § 112 (pre-AIA ), first paragraph:
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 the invention.
21) Claims 9, 20 and 21 are 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 claims contain 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 the (pre-AIA ), the Applicant. This is a new matter rejection.
New claims 20 and 21 and claim 9 as amended, set forth below, include limitations indicated below in bold, which limitations lack descriptive support in the as-filed specification:
20. (New) The method of claim 3, wherein the Akkermansia muciniphila is present in the composition in an amount of from 1.104 to 1.1012 cells, from 1.105 cells to 1.1011 cells, or from 1.106 to 1.1010 cells.
21. (New) The method of claim 15, wherein the Akkermansia muciniphila is present in the composition in an amount of from 1.104 to 1.1012 cells, from 1.105 cells to 1.1011 cells to 1.1011 cells, or from 1.106 to 1.1010 cells.
9. (Currently Amended) The composition of claim [[1]]2, wherein the pasteurized Akkermansia muciniphila is present in the composition in an amount of from 1.104 to 1.1012 cells per day, more preferably from 1.105 cells to 1.1011 cells to 1.1011 cells or from 1.106 to 1.1010 cells
There is no descriptive support for the above-identified limitations. Therefore, the above-identified limitations in the claim(s) and/or the current scope of the claim(s) constitute new matter. See M.P.E.P 608.04 to 608.04(c).
Applicants are invited to point to the descriptive support in specific pages and lines of the disclosure, as originally filed, for the limitation identified above, or alternatively, remove the new matter from the claim(s). Applicants should specifically point out the support for any amendments made to the disclosure. See MPEP 714.02 and 2163.06.
Rejection(s) under 35 U.S.C § 103
22) 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 of this title, 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 claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 148 USPQ 459, that are applied 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 unobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were effectively filed absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned at the time a later invention was effectively filed in order for the examiner to consider the applicability of 35 U.S.C § 102(b)(2)(C) for any potential 35 U.S.C § 102(a)(2) prior art against the later invention.
23) Claims 1, 3, 4, 7-11, 15 and 20-27 are rejected under 35 U.S.C § 103 as being unpatentable over Sheng et al. (The FASEB J. 32: 6371-6384, December 2018, od record) as evidenced by Wolfram et al. (Annals of Nutrition & Metabolism 49(1): 54-63, pages 1-2, 2005).
It is noted that the Akkermansia muciniphila comprised in the composition of the instant claims is not required to be pasteurized.
Sheng et al. taught an oral EGCG composition and a Akkermansia muciniphila composition. The oral Akkermansia muciniphila composition comprising 109 CFU in PBS and the oral EGCG composition comprising 100 micrograms of EGCG or Teavigo from DSM Nutritional Products, Basel, Switzerland were administered per day to Western diet-fed mice in a method for reducing body weight (i.e., promoting weight loss) or diet-induced obesity. Sheng et al. taught that both Akkermansia muciniphila and EGCG are effective in treating diet-induced obesity. Sheng et al. taught that green tea-reduced body fat and plasma leptin are accompanied by increased Akkermansia muciniphila. Sheng et al. further taught that A. muciniphila treatment can reverse fat-mass gain, metabolic endotoxemia, adipose tissue macrophage infiltration, and insulin resistance caused by a high-fat diet. Sheng et al. expressly taught that investigation is warranted to see whether EGCG and Akkermansia muciniphila would be a synbiotic treatment for obesity-associated comorbidities. See lines 11-12 of ABSTRACT; paragraph bridging the two columns 6372; lines 9-14 of 1st full paragraph of page 6382; 4th full sentence in the last partial paragraph in left column of page 6382; and lines 3-5 in right column of page 6382. That the prior art Teavigo product is recognized in the art as Green Tea Extract, EGCG is implied in the teachings of Sheng et al. in light of what was known in the art. For example, Wolfram et al. taught that TEAVIGO is Green Tea Extract, EGCG in a pure form, and that its supplementation prevented diet-induced obesity in mice, decreased subcutaneous and epididymal adipose tissue weights, reversed the established obesity, and markedly decreased fatty acid synthase acetyl-CoA carboxylase-1 mRNA levels in adipose tissue of EGCG-supplemented mice. See page 1.
Sheng et al. are silent on a composition comprising both Akkermansia muciniphila and the EGCG green tea extract.
However, given Sheng’s express teaching including that both Akkermansia muciniphila and EGCG are effective in treating diet-induced obesity, it would have been prima facie obvious to one of ordinary in the art before the effective filing date of the claimed invention to combine the prior art Akkermansia muciniphila composition and the EGCG green tea extract composition to produce the instant invention. It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose in order to form a third composition which is to be used for the very same purpose. MPEP 2144.06 states:
It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose .... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
The combined anti-obesity health benefits or beneficial effects of the two prior art compositions would have been expected to be enhanced as the effects would have been expected to be additive. The reason to combine the two compositions is to produce a product with added anti-obesity health benefits. See KSR International Co v Teleflex 82 USPQ2d 1385 (US 2007) at page 1397. Moreover, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), states that "the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results".
Claims 1, 3, 4, 7-11, 15 and 20-27 are prima facie obvious over the prior art of record.
24) Claims 2, 5, 6 and 16-19 are rejected under 35 U.S.C § 103 as being unpatentable over Sheng et al. (The FASEB J. 32: 6371-6384, December 2018, of record) as evidenced by Wolfram et al. (Annals of Nutrition & Metabolism 49(1): 54-63, pages 1-2, 2005) as applied to claims 1, 3 and 15 above and further in view of WO 2017/042347 A1 (of record).
The teachings of Sheng et al. as evidenced by the document Wolfram et al. as modified are set forth supra, which are silent on the Akkermansia muciniphila being pasteurized.
However, WO 2017/042347 A1 disclosed pasteurized Akkermansia muciniphila and a composition such as a nutritional composition, a pharmaceutical composition or a medicament comprising the same for promoting weight loss or treating metabolic syndrome in a subject in need thereof. WO 2017/042347 A1 also taught co-administering said composition with another probiotic bacteria with beneficial health effects and/or one or more prebiotics such as unprocessed oatmeal, which is expected to contain a vitamin or mineral. See Abstract; lines 5-7 of page 6; page 8; lines 3-5 or page 31and claims.
Given the disclosure in WO 2017/042347 A1, it would have been prima facie obvious to one of ordinary in the art before the effective filing date of the claimed invention to use WO 2017/042347 A1’s pasteurized Akkermansia muciniphila in place of the Akkermansia muciniphila in Sheng’s composition modified as explained to produce the instant invention.
Substitution of one art-known Akkermansia muciniphila with another, alternative, art-known Akkermansia muciniphila would have been well within the realm of routine experimentation, would have been obvious to a skilled artisan, and would have brought about similar predictable results or effects. To those of ordinary skill in an art, it is generally obvious to replace a known product by substituting a known equivalent for one of its components. See e.g., Hotchkiss v. Greenwood, 52 U.S. 248 (1850) (substitution of porcelain door knob in known process of making metal or wood door knobs held obvious); In re Mayne, 104 F.3d 1339, 1340 (Fed. Cir. 1997) (‘Because the applicants merely substituted one element known in the art for a known equivalent, this court affirms [the rejection for obviousness’]. It would have been also obvious to include WO 2017/042347 A1’s probiotic bacteria and/or prebiotics such unprocessed oatmeal thereto to confer additional beneficial effects to said prior art composition. As set forth in KSR Int'l Co. v. Teleflex Inc., 27 S. Ct. 1727, 1741-42, 82 USPQ2d 1385, 1397 (2007), ‘[i]n determining whether the subject matter of a patent claim is obvious, neither the particular motivation nor the avowed purpose of the patentee controls. What matters is the objective reach of the claim. If the claim extends to what is obvious, it is invalid under § 103’; see also In re Beattie, 974 F.2d 1309, 1312, 24 USPQ2d 1040, 1042 (Fed. Cir. 1992) ([T]he law does not require that the references be combined for the reasons contemplated by the inventor). KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007) discloses that if a technique has been used to improve one method and a person of ordinary skill would recognize that it would be used in similar methods in the same way using the technique is obvious unless its application is beyond that person’s skill. The Supreme Court has recently emphasized that "the [obviousness] analysis need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007). In KSR Int’l v. Teleflex Inc., the Supreme Court indicated that ‘[w]hen a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one. If a person of ordinary skill can implement a predictable variation, 103 likely bars its patentability.’ KSR Int’l v. Teleflex Inc., 127 S. Ct. at 1727, 1740 (2007).
Claims 2, 5, 6 and 16-19 are prima facie obvious over the prior art of record.
25) Claims 12-13 are rejected under 35 U.S.C § 103 as being unpatentable over Sheng et al. (The FASEB J. 32: 6371-6384, December 2018) as evidenced by Wolfram et al. (Annals of Nutrition & Metabolism 49(1): 54-63, pages 1-2, 2005) as applied to claim 1 above and further in view of Anhe et al. (Gut Microbes 7: 146-153, 2016).
The teachings of Sheng et al. as evidenced by Wolfram et al. as modified are set forth supra, which are silent on the composition further comprising a second plant extract as claimed.
However, Anhe et al. showed that administration of a polyphenol-rich cranberry ( Vaccinium oxycoccos) extract prevented weight gain and ameliorated several features of the metabolic syndrome in association with a strong increase in the abundance of Akkermansia in the gut microbiota of mice by providing a prebiotic effect. Anhe et al. taught their finding was the first evidence of a polyphenol-rich extract from berries improving the metabolic syndrome through a prebiotic effect on Akkermansia. Anhe et al. further taught that these findings were confirmed by a more recent study using a concord grape extract that improved metabolic features in DIO-mice which was also associated with a prebiotic effect. See the first three full sentences of 1st full paragraph of page 147.
It would have been prima facie obvious to one of ordinary in the art before the effective filing date of the claimed invention to add Ahne’s polyphenol-rich cranberry extract to the combined prior art Akkermansia muciniphila composition and the EGCG green tea extract composition as modified to produce the instant invention. It is prima facie obvious to combine compositions each of which is taught by the prior art to be useful for the same purpose in order to form another composition or method which is to be used for the very same purpose. MPEP 2144.06 states:
It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose .... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
The combined body weight-reducing or body weight-inhibiting beneficial effects of the prior art compositions would have been expected to be enhanced in the claimed method as the effects would have been expected to be additive. The reason to combine the prior art compositions is to produce a product with added beneficial effects. See KSR International Co v Teleflex 82 USPQ2d 1385 (US 2007) at page 1397. Moreover, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), states that "the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results".
Claims 12-13 are prima facie obvious over the prior art of record.
Double Patenting Rejection(s)
26) 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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accomplished by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional, the reply must be complete. MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying:online/eterminal-disclaimer.
27) Claims 3, 4 and 15-27 are provisionally rejected under the judicially created doctrine of nonstatutory double patenting as being unpatentable over claims 14, 15, 5, 2, 3, 4, 6-13 and 1 of the co-pending 18684681 application. Although the claims are not identical, they are not patentably distinct from each other. The method of the co-pending ‘681 application, drawn to a method of treating or preventing obesity, IBS and diabetes in a subject in need thereof comprising orally administering to the subject a therapeutically effective amount of pasteurized Akkermansia muciniphila and Camellia sinensis plant extract, reads on the method of instant claims drawn to a method of treating or preventing a metabolic disorder including obesity, irritable bowel disease (IBS) and diabetes mellitus comprising orally administering to the subject a therapeutically effective amount of pasteurized Akkermansia muciniphila and Camellia sinensis plant extract (EGCG) as claimed.
This is a provisional non-statutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
28) No claims are allowed.
(a) The citation of incomplete references in the specification such as “Wooten et al., 2021)” is objected to.
(b) The substitute specification filed 03/30/26 is objected to because of improper single spaced lines. The spacing of the lines of the instant specification is such as to make reading and examination extremely difficult. Substitute specification papers with lines 1.5 or double spaced on good quality paper are required. See Patent Rules § 41.106 (a) (2) (ii) and MPEP Chapter 600.
(c) The recitation “2.108” within the limitation ‘2.108 TFU....” at line 8 of page 17 of the original specification is objected to since it is unclear what precise number it represents or encompasses. The period placed next to “2” further renders the recitation uninterpretable.
(d) Claim 13, as amended, is objected to for the redundant or duplicative recitation of “Vaccinium macrocarpon”. See lines 2 and 3.
29) Applicants’ amendment necessitated the new ground(s) of rejection presented in this Office action. THIS ACTION IS MADE FINAL. Applicants are reminded of the extension of time policy as set forth in 37 C.F.R 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 extension fee pursuant to 37 C.F.R 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.
Correspondence
30) Any inquiry concerning this communication or earlier communications from the Examiner should be directed to S. Devi, Ph.D., whose telephone number is (571) 272-0854. A message may be left on the Examiner’s voice mail system. The Examiner is on a flexible work schedule, however she can normally be reached Monday to Friday from 8.00 a.m. to 4.00 p.m. (EST). If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor Jeffrey Stucker, can be reached at (571) 272-0911. The fax phone number for the organization where this application or proceeding is assigned (571) 273-8300.
31) Information regarding the status of an application may be obtained from Patent Center. Status information for unpublished applications is available through Patent Center or Private PAIR to authorized users only. Should you have questions about access to Patent Center or the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, Applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
/S. DEVI/
S. Devi, Ph.D.Primary Examiner
Art Unit 1645
September, 2026
