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
Applicant’s amendment in the reply filed on 8/12/2-26 is acknowledged, with the additional newly added Claims 38. Claims 18-38 are pending. Claims 18-38 are examined on the merits.
Any rejection that is not reiterated is hereby withdrawn.
Claim Objections
Claims 19, 24, 25, and 35-37 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 26-31 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.
This is a new rejection necessitated by the Applicant’s amendment filed on 8/12/2026.
Claims 26-31 recite the following limitations in the claims, and there is insufficient antecedent basis for these limitations in the claims:
“the fraction” at line 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 § 102/103
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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
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, 20-23, 32-34, and 38 are newly rejected under 35 USC § 102 (b) as being anticipated by or, in the alternative, under 35 U.S.C. 103(a) as obvious over Lin et al (Lin et al, Hypnotic Effects of Lactobacillus fermentum PS150(TM) on Pentobarbital-Induced Sleep in Mice. Nutrients, (2019 Oct 09) Vol. 11, No. 10, pp 1-13).
This is a new rejection necessitated by the Applicant’s amendment filed on 8/12/2026.
Lin et al teach the bidirectional communication between the gastrointestinal tract and the central nervous system appears to be functionally linked to the intestinal microbiome, namely the microbiome-gut-brain axis (MGBA). Probiotics with health benefits on psychiatric or neurological illnesses are generally called psychobiotics, and some of them may also be able to improve sleep by targeting the MGBA. This study aimed to investigate the effects of a psychobiotic strain, Lactobacillus fermentum PS150(TM) (PS150(TM)) (thus the claimed lactic acid bacterium, thus claims 20-22 are met), on sleep improvement (thus a method for treating a subject in need of improved sleep quality) by using a pentobarbital-induced sleep mouse model. Compared with the vehicle control group, the oral administration (thus claim 32 are met) of PS150(TM), but not the other L. fermentum strains, significantly decreased the sleep latency (thus claim 38 is met) and increased the sleep duration of mice, suggesting strain-specific sleep-improving effects of PS150(TM). Moreover, the ingestion of diphenhydramine, an antihistamine used to treat insomnia, as a drug control group, only increased the sleep duration of mice. We also found that the sleep-improving effects of PS150(TM) are time- and dose-dependent. Furthermore, the oral administration of PS150(TM) could attenuate a caffeine-induced sleep disturbance in mice, and PS150(TM) appeared to increase the expression of the gene encoding the adenosine 1 receptor in the hypothalamus of mice, as assessed by quantitative real-time polymerase chain reaction. Taken together, our results present a potential application of PS150(TM) as a dietary supplement for sleep improvement (see Abstract).
Lin et al teach for mouse experiments, the L. f"t--rmenturn culture was harvested using centrifugation (10,000x g,10 min) (thus an extract, thus claim 23 is met), washed twice with sterile phosphate-buffered saline (PBS), and re-suspended with PBS (thus a liquid, thus claim 33 is met) to a final concentration of apprnxi.7nately 10rn colony-forming units (CFU)/mL (page 2, 3rd paragraph from the bottom).
As discussed above, the cited references disclose the claimed method for treating a subject in need of improved sleep quality with the claimed Lactobacillus fermentum PS150. Although the cited reference does not explicitly teach the claimed Lactobacillus fermentum PS150 contains the claimed exopolysaccharides (EPS), the claimed Lactobacillus fermentum PS150 would inherently contain the claimed exopolysaccharides (EPS). Consequently, the claimed method appears to be anticipated by the references.
In the alternative, even if the claimed method is not identical to the referenced method with regard to some unidentified characteristics, the differences between that which is disclosed and that which is claimed are considered to be so slight that the referenced method is likely to inherently possess the same characteristics of the claimed method particularly in view of the similar characteristics which they have been shown to share. Thus, the claimed method would have been obvious to those of ordinary skill in the art with the meaning of U.S.C. 103.
Accordingly, the claimed invention as a whole was at least prima facie obvious, if not anticipated by the reference, especially in the absence of sufficient, clear, and convincing evidence to the contrary.
With respect to the art rejection above, please note that Patent and Trademark Office is not equipped to conduct experimentation in order to determine whether Applicants’ method differs and, if so, to what extent, from that of discussed references. Therefore, with the showing of the references, the burden of establishing non-obviousness by objective evidence is shifted to the Applicants.
Applicant’s arguments have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 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 CFR 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 date of this final action.
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 8:30 am to 5:00 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anand Desai can be reached on 571-272-0947. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Qiuwen Mi/
Primary Examiner, Art Unit 1655
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