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 .
Preliminary Amendment
1) Acknowledgment is made of Applicants’ preliminary amendment filed 05/08/23.
Status of Claims
2) Claims 3-15 amended via the preliminary amendment filed 05/08/2023.
Claims 3-15 are pending and are examined on the merits.
Information Disclosure Statement
3) Acknowledgment is made of Applicant’s Information Disclosure Statement 05/08/23. The information referred to therein has been considered and a signed copy is attached to this Office Action.
Priority
4) The instant AIA application filed 05/08/2023 is the national stage 371 application of PCT/EP2021/080505 filed 11/03/2021, which claims priority to the application 20205802 filed 11/09/2020. It is noted that a certified copy of the foreign priority application as required by 37 CFR 1.55 is of record. Should Applicants desire to obtain the benefit of foreign priority under 35 U.S.C 119(a)-(d), a certified English translation thereof should be submitted under 37 CFR 1.55 in reply to this Office Action. Failure to do so may result in no benefit being accorded.
reply to this Office Action. Failure to do so may result in no benefit being accorded.
Objection(s) to Specification
5) The specification is objected to for the following reason(s):
(a) The use of trademark recitations in the instant specification has been noted. For example, see last line of page 11 for ‘tween 80’. All trademark recitations should be CAPITALIZED wherever they appear, or where appropriate, should include a proper symbol indicating use in commerce such as TM, SM, or ® following the term. See M.P.E.P 608.01(v) and Appendix l. Although the use of trademarks is permissible in patent applications, the propriety nature of the marks should be respected and every effort made to prevent their use in any manner, which might adversely affect their validity as trademarks. It is suggested that Applicants examine the whole specification to make similar corrections to trademark recitations, wherever such recitations appear.
(b) The instant specification incorporates subject matter into the patent application by reference to a hyperlink “http”. For example, line 10 of page 2. However, attempts to incorporate subject matter into the patent application by reference to an active hyperlink and/or other forms of browser-executable code is considered to be an improper incorporation by reference. See MPEP 608.01. Such embedded active hyperlinks and/or other forms of browser-executable code therefore require deletion or replacement with the phrase --hypertext transfer protocol--. MPEP § 608.01. It is suggested that Applicants examine the whole specification for similar recitations and make necessary correction.
Rejection(s) under 35 U.S.C § 112(b) or (pre-AIA ) Second Paragraph
6) 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.
7) Claims 2-15 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 inventor or a joint inventor, or for the pre-AIA the Applicant regards as the invention.
(a) The dependent claims 2-13 are indefinite for lacking sufficient antecedence in the limitation “Composition according to claim 1”. It is suggested that Applicants provide proper antecedence by replacing the above-identified phrase with --The composition according to claim 1--.
(b) Claim 2 is indefinite for lacking sufficient antecedence in the limitation “Akkermansia muciniphila”. For proper antecedence, it is suggested that Applicants replace the above-identified limitation with --the Akkermansia muciniphila--.
(c) Claim 5 is ambiguous and indefinite in the phrase “chosen from group consisting of ..... or”. For the purpose of distinctly claiming the subject matter, it is suggested that Applicants replace the above-identified phrase with the proper Markush format --selected from the group consisting of ...... and--.
Claims 8-10 are indefinite, because the claims improperly claim both a product and the method step of using the product via the limitations: “is ... administered”. Note that a claim which claims both a product and the method step of using the product or an element of the product is indefinite. MPEP 2173.05.
Regarding claims 9 and 10, the phrase "preferably", or “more preferably” or “even more preferably” renders the claim(s) indefinite because the claim(s) include(s) elements not actually disclosed (those encompassed by "or the like"), thereby rendering the scope of the claim(s) unascertainable. See MPEP § 2173.05(d).
(f) Claim 13 is indefinite for having improper antecedence in the limitations “the second plant extract” [Emphasis added]. Claim 13 depends from claim 1, which does not recite any “second plant extract”. Do Applicants intend the amended claim 13 to depend from claim 12 instead of claim 1?
Claim 13 is ambiguous and indefinite in the phrase “chosen from group consisting of ..... , Vaccinium”. For the purpose of distinctly claiming the subject matter, it is suggested that Applicants replace the above-identified phrase with the proper Markush format --selected from the group consisting of ......, and Vaccinium--.
Claim 14 is indefinite for lacking sufficient antecedence in the limitation “composition according to claim 1”. For proper antecedence, it is suggested that Applicants replace the above-identified limitation with --the composition according to claim 1--.
Claim 14 is indefinite for having improper antecedence in the limitation “the Akkermansia”. Claim 14 depends from claim 1 which includes the limitation --Akkermansia muciniphila--.
Claim 14 is indefinite for having improper antecedence in the limitation “the .... powder”. There is no prior recitation of any powder in the claim or in claim 1 from which it depends.
Notice Re Prior Art Available under Both Pre-AIA and AIA
In the event the determination of the status of the application as subject to AIA 35 U.S.C § 102 and § 103 (or as subject to pre-AIA 35 U.S.C § 102 and § 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection would be the same under either status.
Rejection(s) under 35 U.S.C § 103
8) 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.
9) Claims 1, 3, 4, 7-11 and 15 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 the document Teavigoâ ((Green Tea Extract, EGCG), NutriScience Innovations, LLC, pages 1-3, No publication date).
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 for reducing body weight 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 inherent from the teachings of Sheng et al. in light of what was known in the art. For example, see the title of the document Teavigoâ.
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 and 15 are prima facie obvious over the prior art of record.
10) Claims 2, 5 and 11 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 the document Teavigoâ ((Green Tea Extract, EGCG), NutriScience Innovations, LLC, pages 1-3, No publication date) as modified and as applied to claim 1 above and further in view of WO 2017/042347 A1 (Applicants’ IDS).
The teachings of Sheng et al. as evidenced by the document Teavigoâ 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 and 11 are prima facie obvious over the prior art of record.
11) Claim 12 is 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 the document Teavigoâ ((Green Tea Extract, EGCG), NutriScience Innovations, LLC, pages 1-3, No publication date) as modified and as applied to claim 1 above and further in view of Uchiyama et al. (Nutrition 27: 287-292, 2011).
The teachings of Sheng et al. as evidenced by the document Teavigoâ as modified are set forth supra, which are silent on the composition further comprising a second plant extract.
However, Uchiyama et al. taught that dietary black tea polyphenols extract prevents diet-induced obesity by inhibiting intestinal lipid absorption. See title and ABSTRACT.
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 Uchiyama’s black tea polyphenols 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 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 inhibiting beneficial effects of the 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 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".
Claim 12 is prima facie obvious over the prior art of record.
Claim(s) Objection(s)
12) Claim 14 and 15 are objected to for lacking a preceding article prior to the limitation ‘Method’ in line 1.
Claim 15 is objected to for including an improper period in the middle of the claim, i.e., at the end of the limitation ‘subject. within the phrase ‘subject. In need thereof.’
Relevant Art
13) The art made of record and not relied upon in any of the rejections is considered pertinent to Applicants’ disclosure:
t Jeong et al. (J. Medicinal Food 23: 841-851, 2020 - Applicants’ IDS) showed that administration of green tea extract significantly encouraged the growth of Akkermansia muciniphila, a beneficial microorganism that relieves obesity and related metabolic disorders. Jeong et al. taught that the epigallocatechin gallate (EGCG) component of the green tea extract stimulates the growth of Akkermansia muciniphila. Jeong et al. further taught that it is feasible that Akkermansia muciniphila could be used to treat diverse metabolic syndromes such as obesity, insulin resistance and type 2 diabetes by suppressing inflammation in the gut. Jeong et al. demonstrated the antiobesity effect of green tea and showed that green tea alleviated glucose and insulin resistance in diet-induced obese mice. Jeong et al. concluded that Akkermansia muciniphila mediates the effects of green tea on obesity and related metabolic disorders and that greet tea containing EGCG functions as a prebiotic agent to maintain the gut environment and health of the hosts. See entire document including ABSTRACT; the sentence bridging pages 841 and 842; MATERIALS AND METHODS; Figures 1 and 3; lines 9-11 of page 850; and first full paragraph of page 850.
Conclusion
14) No claims are allowed.
Correspondence
15) 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 7.00 a.m. to 4.00 p.m. (EST). If attempts to reach the Examiner by telephone are unsuccessful, the Examiner's Supervisor, Gary Nickol, can be reached at (571) 272-0835. The fax phone number for the organization where this application or proceeding is assigned (571) 273-8300.
16) 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
July, 2025
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