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 .
Specification
The use of the term tween 80 (page 9), which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary 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 commercial marks.
Appropriate correction is required.
The disclosure is objected to because of the following informalities:
In page 3, line 27, “Olea Europa” should read as “Olea Europaea”.
Appropriate correction is required.
Claim Objections
Claim 14 is objected to because of the following informalities:
In claim 14, “Olea Europa” should read as “Olea Europaea”. In addition, “or” should be inserted between “oxycoccos” and “Vaccinium” in line 4.
Appropriate correction is required.
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 5-7 and 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 the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 5 is indefinite because it is unclear what “sufficiently in advance” means; the specification does not list the exact meaning of the phrases. It is unclear how many days or hours is considered “sufficiently in advance” in terms of administering the pasteurized bacterium before the onset of the non-depressive disorders.
Claims 6 and 7 are indefinite because the claims list both a broad range and a narrower range within the same claims.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 6 recites the broad recitation “2 to 10 days”, and the claim also recites “preferably 3 to 7 days” and “even more preferably 4 to 6 days” which are the narrower statements of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
In addition, claim 7 recites the broad recitation “1.104 to 1.1012 cells per day”, and the claim also recites “more preferably 1.105 to 1.1011 cells per day” and “even more preferably 1.106 to 5.1010 cells per day” which are the narrower statements of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Furthermore, in claim 7, the recitation of “5.1010” is indefinite because “5.1010” is outside of the first range, i.e. “1.104 to 1.1012 cells per day”.
Claim 15 is indefinite because it is directed to a non-medical “use”. “Use” type claims are not a statutory category of invention. Thus, it is unclear if the claims are a method or a composition. Thus, the metes and bounds of the claim are unclear. For the sake of examination, this claim is examined as a composition with an intended use because this is the broadest reasonable interpretation of the claim and because the claim does not contain any active method steps. In addition, it is unclear what is considered a “non-medical” use in comparison with “medical” use. It is unclear what limitations are meant to be implied by “non-medical”; thus, the metes and bounds of the claim are unclear.
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.
Claim 15 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim does not fall within at least one of the four categories of patent eligible subject matter because it is directed to a “use” type claim which is a non-statutory category of invention.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-13 and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cani (WO 2017042347 – English translation provided).
Regarding claims 1-5 and 15, the Cani reference teaches a pasteurized Akkermansia muciniphila (abstract), teaches a pasteurized Akkermansia muciniphila or fragments thereof used for treating a metabolic disorder such as irritable bowel syndrome (abstract and page 5).
Regarding claim 6, the Cani reference teaches pasteurized Akkermansia muciniphila or a fragment thereof, or the composition, pharmaceutical composition or medicament of the invention is administered during 1 week ([7 days]) (page 20).
Regarding claims 7-8, the Cani reference teaches pasteurized Akkermansia muciniphila administered per day [is] 1.109 to about 1.1010 cfu/day (page 22).
Regarding claim 9, the Cani reference teaches adding prebiotics and probtioic bacteria and yeast to the pasteurized Akkermansia muciniphila (pages 28-31).
Regarding claim 10, the Cani reference teaches adding excipients, diluent and/or carriers to food ingredients ([including but not limited to]) such as milk, yogurt [that also contains vitamins and minerals] [with the pasteurized Akkermansia muciniphila] (page 31-32).
Regarding claims 11-13, the Cani reference teaches medicament further comprises [including but not limited to a prebiotic like]: unprocessed oatmeal (page 31), teaches Akkermansia muciniphila or fragments thereof as described hereinabove in association with a pharmaceutically acceptable vehicle (page 6), teaches said composition for use is orally administered (page 5), and Cani teaches the composition can be a medical food (page 32).
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.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Cani (WO 2017042347 – English translation provided) in view of Mahony et al (Gastrointestinal Pharmaology, (Year: 2017), vol. 239, pp. 219-246) and Managoli (U.S. Pub. No. US 2009/0263466 A1) or Kravtsov (CA Pub. No. 3094903 A1) or Baron (JP 2014501787 A5 – English translation provided) or Theoharides (U.S. Pub. No. US 2005/0220907 A1) or Peng (CN 110604833 A – English translation provided) or Khoo (U.S. Patent No. US 9,895,341) or Gonzales (U.S. Pub. No. US 2006/0147600 A1) or Faria (U.S. Pub. No. US 2017/0028012 A1) or Rana (CA Pub. No. 3110996 A1).
The teachings of Cani are above.
Mahony et al teaches stress-related disorders including anxiety often precede the development of irritable bowel syndrome and vice versa (abstract).
Managoli teaches a composition that contains the Camellia sinensis extract used for treating stress and anxiety (paragraph 0005).
Kravtsov teaches a pharmaceutical composition that comprises chokeberry Aronia melanocarpa extract [that is used to treat] irritable bowel syndrome (page 6).
Baron teaches a composition that comprises amla [that can be used] to treat irritable bowel syndrome (page 32 and page 40).
Theohardies teaches a composition that contains an olive extract used to [treat] irritable bowel syndrome (paragraph 0024).
Peng teaches a composition that comprises [including but not limited to] bergamot extract that [can be used] to [calm anxiety] (abstract).
Khoo discuss using a cranberry extract to treat irritable bowel syndrome (abstract and paragraph 9).
Gonzales teaches a health food composition that includes the extract of camu-camu (abstract) and that camu-camu is anti-stress (paragraph 0026).
Faria teaches a dietary supplement that comprises Asian ginseng extract that can reduce stress (paragraph 0021 and paragraph 0025).
Rana teaches a botanical extract from Vaccinium oxycoccus that can be used to modulate a metabolic disorder (abstract and page 7, paragraph 0036).
The medical food composition as taught by Cani can be modified to include the extracts of Camellia sinensis as taught by Managoli, Aronia melanocarpa as taught by Kravtsov, Emblica officinalis (e.g. amla) as taught by Baron, Olea Europaea (e.g. olive) as taught by Theoharides, Citrus bergamia (e.g. bergamot) as taught by Peng, Vaccinium macrocarpon (e.g. cranberry) as taught by Khoo, Myrciaria dubia (e.g. camu camu) as taught by Gonzales, Red panax ginseng (e.g. Asian ginseng or ginseng) as taught by Faria, or Vaccinium oxycoccus as taught by Rana that all serve in either reducing or treating stress, anxiety or IBS, in which, IBS can in turn, treat those symptoms (e.g. anxiety or stress) in a subject in need.
It is well known that it is prima facie obvious to combine two or more ingredients 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 useful for the same purpose. The idea for combining them flows logically from their having been used individually in the prior art. See MPEP section 2144.06, In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980), Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992).
One would reasonably expect that the combination of references show that it was well known in the prior art to use the composition, pasteurized A. muciniphila with prebiotics (such as unprocessed oatmeal) or with dairy products that contains a multitude of vitamins and/or minerals, with a pharmaceutically acceptable carrier (e.g. water), or a plant extract in order to treat anxiety, stress or any non-depressive mood disorders that are related to IBS.
Conclusion
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NASHARA L MOREAUExaminer, Art Unit 1655
/SUSAN HOFFMAN/Primary Examiner, Art Unit 1655