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 2/26/26 is acknowledged, with the cancellation of Claim 57. Claims 47-56 are pending. Claims 47-56 are examined on the merits.
Any rejection that is not reiterated is hereby withdrawn.
Claim Rejections –35 USC § 112, 2nd
The following is a quotation of the second paragraph of 35 U.S.C. 112:
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 48-53 remain 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 rejection is maintained for reasons of record set forth in the Office Action mailed out on 12/2/25, repeated below, slightly altered to take into consideration Applicant’s amendment filed on 2/26/26. Applicants’ arguments filed have been fully considered but they are not deemed to be persuasive.
Claim 48 recites “said peripheral serotonin:tryptophan” at lines 2-3. It is not clear what “peripheral serotonin:tryptophan” means, and there is no antecedent basis in claim 47 for that recitation.
Claim 53 recites “The method of claim 49, wherein said natural photoperiod comprises at least 8 hours of darkness”. However, claim 49 does not mention anything about “natural photoperiod”, does Applicant mean to recite “claim 52” instead of “claim 49”?
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 § 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 47-56 remain rejected under 35 U.S.C. 103(a) as being unpatentable over Verlhac et al (WO 2020097446 A1), in view of Xi et al (Xi et al, The antidepressant-like effect of trans-astaxanthin involves the serotonergic system. Oncotarget, (2017 Apr 11) Vol. 8, No. 15, pp. 25552-25563).
This rejection is maintained for reasons of record set forth in the Office Action mailed out on 12/2/25, repeated below, slightly altered to take into consideration Applicant’s amendment filed on 2/26/26. Applicants’ arguments filed have been fully considered but they are not deemed to be persuasive.
Verlhac et al teach the present disclosure relates to methods of feeding animals by providing feed additives that modulate the gut microbiome to prevent or treat dysfunctions in a gastrointestinal barrier (thus improving the health of a group of production animal kept in a confined space, thus claim 47 is met). The present disclosure further relates to methods of feeding animals by providing feed additives that modulate the gut microbiome to prevent or treat infections (see Abstract). Verlhac et al teach the method of any preceding claim, wherein the animal is a poultry, seafood, sheep, cow, cattle, buffalo, bison, pig, cat, dog, rabbit, goat, guinea pig, donkey, camel, horse, pigeon, ferret, gerbil, hamster, mouse, rat, fish, shrimp, or bird (see claim 133) (thus claim 56 is met). Verlhac et al teach beginning on day 9, cages were assigned to one of four treatment groups with two cages per treatment group [00753] (thus animals kept in a confined space). Verlhac et al teach in one aspect, provided herein are methods of manufacturing an oligosaccharide preparation comprising heating an aqueous composition comprising one or more feed sugars and a catalyst to a temperature and for a time sufficient to induce polymerization, wherein the catalyst is selected from the group consisting of: tryptophan, etc. [00351]. Verlhac et al teach gastrointestinal tissues include, e.g., oral tissue, esophagus, stomach, intestine, ileum, cecum, colon or rectum. Samples also include feces (thus claim 48 is met), saliva, urine, and gastrointestinal ascites. Methods of obtaining gastrointestinal samples are standard and known to the skilled artisan. In some embodiments said sample is a blood or serum sample [00478]. Verlhac et al teach improvements in bowel function (thus caused by the administration of the synthetic oligosaccharide preparations described herein can also be measured by decreased diarrhea, a decrease in one or more symptoms of leaky gut, increased solid stool, increased production of 5-hydroxy-tryptophan and 5-hydroxytryptamine (thus increase of the claimed serotonin) and 2-methyl-5-hydroxytryptamine, and other neurotransmitter precursors that can be made by bacterial populations (serotonin precursors) [00463]. Verlhac et al teach the method of any preceding claim, wherein said animal has decreased inflammation (thus local or systemic, thus claims of a gastrointestinal barrier relative to inflammation of said gastrointestinal barrier of a comparable control animal administered a nutritional composition lacking said synthetic oligosaccharide preparation. (see claim 52) (thus claims 49-53 are met). Verlhac et al teach an animal may not achieve its performance target minimum FCR when raised in a challenged environment, which may include, for example, environmental pathogenic stress, excessive environmental temperature (heat stress), excessive environmental humidity, crowding, or other social interaction effects, such as difficulty accessing feed or drinking water. In some embodiments, an animal may not achieve its performance target minimum FCR due to disease or environmental pathogenic stress [00483].
Verlhac et al teach do not teach the ratio of serotonin:tryptophan in the brain is increased for at least 20%.
Xi et al teach the antidepressant-like effect of trans-astaxanthin, a compound present rich in algae, was evaluated through behavioral and neurochemical methods. Results showed that trans-astaxanthin treatment significantly decreased the immobility time in force swim test and tail suspension test, but did not influence locomotor activity. Trans-astaxanthin treatment did not effectively antagonize hypothermia and ptosis induced by reserpine. However, pre-treatment with para-chlorophenylalanine abolished the anti-immobility effect of trans-astaxanthin in force swim and tail suspension test. These results suggested that the mechanism of antidepressant-like effect of trans-astaxanthin may involve the serotonergic system, but not noradrenaline system. This hypothesis was confirmed by neurochemical assays which showed that trans-astaxanthin increased serotonin levels in the hippocampus, frontal cortex, striatum and hypothalamus. Furthermore, our data suggested that trans-astaxanthin decreased indoleamine 2, 3-dioxygenase activity in the hippocampus, frontal cortex and hypothalamus. Inhibition of indoleamine 2,3-dioxygenase activity subsequently decreased the kynurenine/tryptophan ratio and increased the serotonin/tryptophan ratio in these brain regions. Taken together, these findings indicate that the antidepressant-like effect of trans-astaxanthin involves the serotonergic system (see Abstract). Xi et al teach serotonin (5HT)/TRY ratio (F) in the frontal cortex (thus in brain) (Figure 3 F), wherein 80 mg/kg group has about 160% of 5-HT/TRY, whereas control group has 100% , (thus at least 20% higher than the control group, claims 47 b) and 57 b) are met). Xi et al teach the mice were housed eight per cage (page 25560, 1st column, 1st paragraph).
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 obtain at least 20% increase of serotonin/tryptophan ratio in these brain regions from Xi et al since both of the references teach increasing serotonin levels in mice or rat confined in the cages, one of the 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.
Applicant’s argument on page 6 has been carefully considered, but they are not found persuasive.
First of all, claim 47 is a method comprising a), b), c), and/or d), it only requires one of a), b), c) or d) requirement is met, instead of all of a), b), c), and d) are all met.
Secondly, reference Verlhac et al is only focus on claim 47 b), the feeding additives yeast cell wall and essential oils selected from the group consisting of thymol, eugenol and piperine only limits claim 47 a), it has nothing to do with claim 47 b), and Verlhac et al do not need to teach decreasing the ratio of tryptamine: tryptophan. Applicant could file RCE, change “and/or” in claim 47 into “and”, and also recite “the feeding additives yeast cell wall and essential oils selected from the group consisting of thymol, eugenol and piperine” at the very beginning of claim 47, before a) starts.
Applicant's arguments have been fully considered but they are not persuasive, and therefore the rejections in the record are maintained.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. 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 mailing date of this final action.
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/Qiuwen Mi/
Primary Examiner, Art Unit 1655