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 .
DETAILED ACTION
Claims 18-37 are pending. Claims 18-37 are examined on the merits.
Claim Objections
Claims 26-29, 34, and 35 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim Rejections –35 USC § 112, 2nd
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 30, 31, 36, and 37 are rejected under 35 U.S.C. 112, second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Claim 30 recites “The method of claim 24, wherein the extract comprises a fraction 2…”, at line 1.
Claim 31 recites “The method of claim 24, wherein the extract comprises a fraction 3…”, at line 1.
The recitation of claims 30 and 31 are very confusing, as claim 24 doesn’t mention anything about fraction 1, and it is very strange to mention fraction 2 or fraction 3 directly.
Claims 36 and 37 are rejected for the same reason, as claim 25 do not mention anything about fraction 1.
Therefore, the metes and bounds of claims are rendered vague and indefinite. The lack of clarity renders the claims very confusing and ambiguous since the resulting claims do not clearly set forth the metes and bounds of the patent protection desired.
All other cited claims depend directly or indirectly from rejected claims and are, therefore, also, rejected under U.S.C. 112, second paragraph for the reasons set forth above.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 18-20, 23-25, 32, and 33 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Stanton et al (WO 2014033307 A1).
Stanton et al teach the invention broadly relates to a bacterial strain, Lactobacillus (thus a lactic acid bacterium, thus claim 20 is met) mucosae DPC 6420, that has been found to express an exopolysaccharide and have cardio-protective properties on a subject when the subject is administered the strain (page 21, lines 18-20) (since the word “preventing” is in claim 18, it doesn’t require that the subject is having a sleeping disorder, it reads on everyone who is being administered with the claimed exopolysaccharides of a lactic acid bacterium, as everyone needs to prevent a sleeping disorder such as insomnia, thus claims 18 and 19 are met).
Stanton et al teach strains were inoculated in MRS (Difeo Laboratories, Detroit, Ml, USA) broth with 5% (w/v) glucose (Sigma-Aldrich, Wicklow, Ireland). Following anaerobic incubation at 37°C for 48 h (thus the claimed culturing the lactic acid bacterium), the pH of the samples was adjusted to pH 6.2 with 4M NaOH followed by overnight hydrolysis using 0.2 mg/ml proteinase K (Sigma-Aldrich, Wicklow, Ireland) at 37°C. To terminate the reaction, the mixture was heated at 90°C for 10 min and centrifuged at 4,000 x g for 30 min (Sorvall®LegendRT, Thermo Scientific, Loughborough, UK). The supernatant was collected (thus removing acterial cell bodies from the bacterial culture to obtain a mixture containing the ESP, thus an extract, thus claim 23 is met) and precipitated with 4 volumes of chilled ethanol (thus precipitating the mixture with ethanol), and agitated (100 rpm) overnight at 4°C. To recover the precipitate, the mixture was centrifuged at 4,500 x g for 30 min. The pellet (thus removing ethanol, thus claim 24 is met) was dissolved in 10 ml of 5 sterile deionised water and dialyzed (molecular mass cut-off of 12,000 Da) (thus falls into the claimed 9kDa and 2000 kDa, thus claim 25 is met) against deionised water for 3 d at 4°C (with two daily washing steps). The mixture was lyophilized (VirTis AdVantage™ Freeze Dryer, SP Industries, NY, USA) and the generated powder was kept at -20°C for further analysis (page 24, last paragraph bridging page 25).
Stanton et al teach Compositional analysis of EPS isolated from Lb. mucosae DPC 6426 indicated that it is comprised of seven monosaccharide residues: xylose, fucose, mannose, glucose, galactose, N-acetylglucosamine, and N-acetylmannosamine (Table 4 ) (page 40, last paragraph).
Stanton et al teach the composition, if desired, can also contain minor amounts of wetting or emulsifying agents, or pH buffering agents. These compositions can take the form of solutions, suspensions, emulsion, tablets, pills, capsules, powders (thus claim 33 is met), sustained-release formulations and the like (page 10, 2nd paragraph).
Stanton et al teach in this specification, the term "administering" should be taken to include any form of delivery that is capable of delivering the bacterial strain to a site of infection, including local delivery, intravenous delivery, oral delivery (thus claim 32 is met), intranasal delivery, intramuscular delivery, intrathecal delivery, transdermal delivery, inhaled delivery and topical delivery (page 9, 3rd paragraph).
Therefore, the reference is deemed to anticipate the instant claim above.
Claim Rejections –35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained through the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claims 18-25, 32, and 33 are rejected under 35 U.S.C. 103(a) as being unpatentable over Stanton et al as applied to claims 18-20, 23-25, 32, and 33 above, and further in view of Ikeda et al (Ikeda et al, Rheological characteristics and supramolecular structure of the exopolysaccharide produced by Lactobacillus fermentum MTCC 25067. Carbohydrate polymers (15 Aug 2019), Volume 218, pp. 226-233, 8 p) (see IDS filed on 2/28/24)
The teachings of Stanton et al are set forth above and applied as before.
The teachings of Stanton et al do not specifically teach the claimed Lactobacillus fermentum MTCC 25067 in claims 21 and 22.
Ikeda et al teach rheological properties and supramolecular structure of the exopolysaccharide (EPS) secreted by Lactobacillus fermentum MTCC 25067 were investigated (see Abstract). Ikeda et al teach size exclusion chromatography (SEC)-multi angle laser light scattering (MALLS) analysis and atomic force microscopy (AFM) imaging were conducted in order to gain insights into the molecular basis of high viscosities and elasticities that the EPS solutions exhibited (page 4, lines 112-115).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to use the claimed Lactobacillus fermentum MTCC 25067 since Ikeda et al teach rheological properties and supramolecular structure of the exopolysaccharide (EPS) secreted by Lactobacillus fermentum MTCC 25067. Since both of the references teach exopolysaccharide (EPS) secreted by Lactobacillus, one of ordinary skill in the art would have been motivated to combine the teachings of the references together.
From the teachings of the references, it is apparent that one of the ordinary skills in the art would have had a reasonable expectation of success in producing the claimed invention.
Thus, the invention as a whole is prima facie obvious over the references, especially in the absence of evidence to the contrary.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QIUWEN MI whose telephone number is (571)272-5984. The examiner can normally be reached on Monday-Friday 9:00 am to 5:00 pm.
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/Qiuwen Mi/
Primary Examiner, Art Unit 1655
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