DETAILED ACTION
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 .
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.
Restriction election
In response to a requirement for restriction dated 08/01/2025, applicant elects species I classification method of claims 6 without traverse per applicant response dated 09/04/2025.
Claim Status
Claims 1-21 are pending.
Claims 8-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected species, as described above.
Claims 1-7 and 11-21 are under examination.
Claims 2-3 and 7 are objected to.
Claims 1-7 and 11-21 are rejected.
Priority
Applicant's claim for the benefit of a prior-filed application, PCT/KR2020/007494, filed 06/10/2020, is acknowledged.
Accordingly, each of claims 1-7, 11, 13, and 17-21 are afforded the effective filing date of 06/10/2020.
Information Disclosure Statement
The information disclosure statements (IDS) filed on 12/09/2021, 10/14/2022, and 12/15/2023 are in compliance with the provisions of 37 CFR 1.97 and have therefore been considered. Signed copies of the IDS documents are included with this Office Action.
Drawings
The Drawings submitted 12/09/2021 are accepted.
Nucleotide and/or Amino Acid Sequence Disclosures
The sequence listing submitted 12/09/2021 has been accepted.
Specification
The disclosure is objected to for the following informalities. It is noted that for purposes of the instant Office Action, any reference to the specification pertains to the clean copy of the substitute specification as originally filed on 12/09/2021.
Hyperlinks
The disclosure as published is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01. Non-limiting examples include paragraphs [0039] and [0141]. Applicant will note that this is exemplary and other instances may exist. It is requested that all instances be corrected.
Appropriate correction for all objections to the specification is required.
Claim Rejections - 35 USC § 112
35 U.S.C. 112(b)
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.
Claims 7, 12-16, 18-19, and 20 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claims 7, 13, 19, and 20, incorporate a reference of a Table in the specification within the claim. Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993).
Claims 12 and 14 recite “the infant development index”. There is insufficient antecedent basis for these limitation in the claim as there is no previous recitation of “an infant development index” and it is unclear what it is. Claim(s) 15-16 is/are rejected for the same reason because they depend from claims 14 and 1 and does not resolve the indefiniteness issue in those claims.
Claim 18 recites “a step of achieving a gut microbial balance by conducing at least one measure selected from the group”. The word “conducing” is unclear in the context of the claims. The claim is being interpreted as “modifying” instead of “conducing” for compact prosecution. Claim(s) 19-20 is/are rejected for the same reason because they depend from claims 18 and does not resolve the indefiniteness issue in those claims.
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.
Claims 1-21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to one or more judicial exceptions without significantly more.
MPEP 2106 organizes judicial exception analysis into Steps 1, 2A (Prongs One and Two) and 2B as follows below. MPEP 2106 and the following USPTO website provide further explanation and case law citations: uspto.gov/patent/laws-and-regulations/examination-policy/examination-guidance-and-training-materials.
Framework with which to Evaluate Subject Matter Eligibility:
Step 1: Are the claims directed to a process, machine, manufacture, or composition of matter;
Step 2A, Prong One: Do the claims recite a judicially recognized exception, i.e. a law of nature, a natural phenomenon, or an abstract idea;
Step 2A, Prong Two: If the claims recite a judicial exception under Prong One, then is the judicial exception integrated into a practical application (Prong Two); and
Step 2B: If the claims do not integrate the judicial exception, do the claims provide an inventive concept.
Framework Analysis as Pertains to the Instant Claims:
Step 1
With respect to Step 1: yes, the claims are directed to method, i.e., a process, machine, or manufacture within the above 101 categories [Step 1: YES; See MPEP § 2106.03].
Step 2A, Prong One
With respect to Step 2A, Prong One, the claims recite judicial exceptions in the form of abstract ideas. The MPEP at 2106.04(a)(2) further explains that abstract ideas are defined as:
mathematical concepts (mathematical formulas or equations, mathematical relationships and mathematical calculations);
certain methods of organizing human activity (fundamental economic practices or principles, managing personal behavior or relationships or interactions between people); and/or
mental processes (procedures for observing, evaluating, analyzing/ judging and organizing information).
With respect to the instant claims, under the Step 2A, Prong One evaluation, the claims are found to recite abstract ideas that fall into the grouping of mental processes (in particular procedures for observing, analyzing and organizing information) and mathematical concepts (in particular mathematical relationships and formulas) are as follows:
Independent claim 1:
determining a developmental stage of the gut microbiome according to criteria for classifying developmental stage of a reference infant, on the basis of at least one selected from the group consisting of the gut microbiome information of step (A) and the metadata information of step (B);
determining the degree of the gut microbiota dysbiosis according to the determined developmental stage, by using biomarkers characteristic of imbalance group and biomarkers characteristic of balance group in each developmental stage.
Dependent claim 2:
analyzing the gut microbiome information of microbial types discriminated at a species level and abundance ratios of the microbial types for gut microbiome in the test infant, by performing an analysis of the 16S rRNA information of gut microbes
Dependent claim 3:
determining criteria for classifying developmental stage of the reference infant, on the basis of at least one selected from the group consisting of the gut microbiome information of step (A') and the metadata information of step (B').
Dependent claim 17:
monitoring a change of imbalance determination index in the test infant with time, after the step of (D).
Dependent claims 4-7, 11, 13, and 18-21 recite further steps that limit the judicial exceptions in independent claim 1 and, as such, also are directed to those abstract ideas. For example, claim 4 further limits the metadata of claim 1, claims 5 and 11 further limit developmental stage of claim 1, claims 6-7 further limit classifying developmental stage of claims 3 and 5, claim 13 further limits the biomarker characteristic of claim 1, claim 18 further limits the gut microbial balance of claim 1, claim 19 further limits the microbial biomarker characteristic of claim 18, claim 20 further limits the developmental stage of claim 18, claim 21 further limits the balance group of claim 1.
The abstract ideas recited in the claims are evaluated under the Broadest Reasonable Interpretation (BRI) and determined to each cover performance either in the mind and/or by mathematical operation because the method only requires a user to manually determine, analyze, and monitor. Without further detail as to the methodology involved in “determining a developmental stage of the gut microbiome”, “determining the degree of the gut microbiota dysbiosis”, “analyzing the gut microbiome information”, “determining criteria for classifying developmental stage “, and “monitoring a change of imbalance determination index “ under the BRI, one may simply, for example, use pen and paper to detect gut dysbiosis of infant.
Therefore, claim 1 and those claims dependent therefrom recite an abstract idea [Step 2A, Prong 1: YES; See MPEP § 2106.04].
Step 2A, Prong Two
Because the claims do recite judicial exceptions, direction under Step 2A, Prong Two, provides that the claims must be examined further to determine whether they integrate the judicial exceptions into a practical application (MPEP 2106.04(d)). A claim can be said to integrate a judicial exception into a practical application when it applies, relies on, or uses the judicial exception in a manner that imposes a meaningful limit on the judicial exception. This is performed by analyzing the additional elements of the claim to determine if the judicial exceptions are integrated into a practical application (MPEP 2106.04(d).I.; MPEP 2106.05(a-h)). If the claim contains no additional elements beyond the judicial exceptions, the claim is said to fail to integrate the judicial exceptions into a practical application (MPEP 2106.04(d).III).
Additional elements, Step 2A, Prong Two
With respect to the instant recitations, the claims recite the following additional elements:
Independent claim 1:
obtaining gut microbiome information of microbial types discriminated at a species level and abundance ratios of the microbial types for gut microbiome in a test infant;
obtaining metadata information of the test infant.
Dependent claim 2:
obtaining genomic DNA of gut microbes from a fecal specimen of the test infant;
obtaining 16S rRNA genetic information from the genomic DNA of the gut microbes
Dependent claim 3:
obtaining gut microbiome information of microbial types discriminated at a species level and abundance ratios of the microbial types for gut microbiome in the reference infant;
obtaining metadata information of the reference infant
Considerations under Step 2A, Prong Two
With respect to Step 2A, Prong Two, the additional elements of the claims do not integrate the judicial exceptions into a practical application for the following reasons. Those steps directed to data gathering, such as “obtaining”, perform functions of collecting the data needed to carry out the judicial exceptions. Data gathering and outputting do not impose any meaningful limitation on the judicial exceptions, or on how the judicial exceptions are performed. Data gathering and outputting steps are not sufficient to integrate judicial exceptions into a practical application (MPEP 2106.05(g)).
Thus, none of the claims recite additional elements which would integrate a judicial exception into a practical application, and the claims are directed to one or more judicial exceptions [Step 2A, Prong 2: NO; See MPEP § 2106.04(d)].
Step 2B (MPEP 2106.05.A i-vi)
According to analysis so far, the additional elements described above do not provide significantly more than the judicial exception. A determination of whether additional elements provide significantly more also rests on whether the additional elements or a combination of elements represents other than what is well-understood, routine, and conventional. Conventionality is a question of fact and may be evidenced as: a citation to an express statement in the specification or to a statement made by an applicant during prosecution that demonstrates a well-understood, routine or conventional nature of the additional element(s); a citation to one or more of the court decisions as discussed in MPEP 2106(d)(II) as noting the well-understood, routine, conventional nature of the additional element(s); a citation to a publication that demonstrates the well-understood, routine, conventional nature of the additional element(s); and/or a statement that the examiner is taking official notice with respect to the well-understood, routine, conventional nature of the additional element(s).
With respect to the instant claims, the courts have found that receiving data are well-understood, routine, and conventional functions when claimed in a merely generic manner or as insignificant extra-solution activity as discussed in MPEP 2106.05(d)(II)(i)).
As such, the claims simply append well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception (MPEP2106.05(d)). The data gathering steps as recited in the instant claims constitute a general link to a technological environment which is insufficient to constitute an inventive concept which would render the claims significantly more than the judicial exception (MPEP2106.05(g)&(h)).
Taken alone, the additional elements do not amount to significantly more than the above-identified judicial exception(s). Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claims as a whole do not amount to significantly more than the exception itself [Step 2B: NO; See MPEP § 2106.05].
Therefore, the instant claims are not drawn to eligible subject matter as they are directed to one or more judicial exceptions without significantly more. For additional guidance, applicant is directed generally to the MPEP § 2106.
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.
The factual inquiries 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 nonobviousness.
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 as of the effective filing date of the claimed invention(s) 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 as of the effective filing date of the later invention 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.
A. Claim(s) 1-7, 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stewart et al. (Stewart, Christopher J., et al. "Temporal development of the gut microbiome in early childhood from the TEDDY study." Nature 562.7728 (2018): 583-588, cited on IDS dated 12/09/2021).
Claim 1 is directed to a method for detecting a developmental stage of gut microbiota and a degree of gut microbiota dysbiosis in infant, the method comprising the steps of: (A) obtaining gut microbiome information of microbial types discriminated at a species level and abundance ratios of the microbial types for gut microbiome in a test infant; (B) obtaining metadata information of the test infant; (C) determining a developmental stage of the gut microbiome according to criteria for classifying developmental stage of a reference infant, on the basis of at least one selected from the group consisting of the gut microbiome information of step (A) and the metadata information of step (B); and (D) determining the degree of the gut microbiota dysbiosis according to the determined developmental stage, by using biomarkers characteristic of imbalance group and biomarkers characteristic of balance group in each developmental stage.
Stewart discloses temporal developmental stages of the gut microbiome in early childhood, comprising: a step of collecting an infant stool sample and collecting metadata; a step of analyzing the sample at a species level through 16S rRNA sequencing and metagenomic sequencing; and a step including three developmental phases according to the microbiome [abstract and p. 587, col. 1, par. 4]. Claim 1 differs from Stewart in terms of comprising step (D) for determining dysbiosis of the gut microbiome by using an imbalanced group-specific biomarker and a balanced group-specific biomarker for each developmental phase according to a determined developmental phase. However, regarding said difference, specific biomarkers for each developmental phase could be easily derived by a person skilled in the art in view of the features of Stewart, wherein, before four years of age, the gut microbiome undergoes three distinct phases; and the phases are most affected by food eaten, Bifidobacterium is abundant in the early developmental phase, and after cessation of breastfeeding, Firmicutes gradually increases and remains stable [abstract; p. 587, col. 1, par. 1, and figure 3].
Claim 2 is directed to the method of claim 1, wherein the step (A) of obtaining gut microbiome information comprise the steps of:(A-1) obtaining genomic DNA of gut microbes from a fecal specimen of the test infant; (A-2) obtaining 16S rRNA genetic information from the genomic DNA of the gut microbes; and (A-3) analyzing the gut microbiome information of microbial types discriminated at a species level and abundance ratios of the microbial types for gut microbiome in the test infant, by performing an analysis of the 16S rRNA information of gut microbes.
Stewart discloses: extracting DNA from the infant stool sample; 16S rRNA sequencing and metagenomic sequencing using the DNA; and performing a species analysis at the genus and species levels [p. 599, col. 1, par. 5].
Claim 3 is directed to the method of claim 1, wherein the criteria for classifying developmental stage of a reference infant are obtained by performing the steps comprising: (A') obtaining gut microbiome information of microbial types discriminated at a species level and abundance ratios of the microbial types for gut microbiome in the reference infant; (B') obtaining metadata information of the reference infant; and (C') determining criteria for classifying developmental stage of the reference infant, on the basis of at least one selected from the group consisting of the gut microbiome information of step (A') and the metadata information of step (B').
Claim 3 could be easily derived by a person skilled in the art from the following steps in Stewart: the step of collecting the infant stool sample and collecting metadata; the step of analyzing the sample; and the step with developmental phases according to the microbiome [abstract and p. 587, col. 1, par. 4].
Claim 4 is directed to the method of claim 1, wherein the metadata information of the test infant comprise at least one factor selected from the group consisting of sex, months of age, height, weight, diet type, feeding mode, feeding of lactic acid bacterium-containing diet, fecal type, fecal color, information on antibiotic use, and information on diagnosed diseases of the infant, and mother's diet type during a gestation period, and mother's diet type and antibiotic administration after delivery.
Stewart discloses wherein the collected metadata includes the birth mode, sex, and age of an infant, the time of introduction of solid food, maternal medication use, and BMI [p. 590, col. 1, par. 1 and figure 2].
Claim 5 is directed to the method of claim 1, wherein the step (C) of determining a developmental stage is conducted using at least one selected from the group consisting of dietary step of the test infant, months of age of the test infant, and microbial biomarkers characteristic of developmental stages.
Stewart discloses wherein the developmental phases of the microbiome are classified into 1) a developmental phase; (months 3-14), 2) a transitional phase (months15-30), and 3) a stable phase (months 31-46) according to the month of age [p. 583, col. 1, par. 1-p. 583 and figure 1].
Claim 6 is directed to the method of claim 3, wherein the step (C') of determining criteria for classifying developmental stage of the reference infant is conducted using at least one selected from the group consisting of dietary step of the reference infant, months of age of the reference infant, and microbial biomarkers characteristic of developmental stages.
Stewart discloses wherein the developmental phases of the microbiome are classified into 1) a developmental phase; (months 3-14), 2) a transitional phase (months15-30), and 3) a stable phase (months 31-46) according to the month of age [p. 583, col. 1, par. 1-p. 583 and figure 1].
Claim 7 is directed to the method of claim 5, wherein when developmental stage is determined to developmental stage 1 or developmental stage 2 by using microbial biomarkers characteristic of developmental stage, the biomarker characteristic of developmental stage 1 is at least one selected from the group consisting of microbes listed in Tables 10 and 11, and the biomarker characteristic of developmental stage 2 is at least one selected from the group consisting of microbes listed in Tables 12 and 13.
Stewart discloses wherein Bifidohucterium dominates in the developmental phase (cluster 1-3), and Faecalibacterium and Lachnospiraceae dominate with the progression to the stable phase [p. 583, coo. 1, par. 1; and figure 1].
Claim 11 is directed to the method of claim 5, wherein the developmental stages are classified in terms of dietary steps including liquid-phase, gel-phase, and solid-phase diets.
Stewart discloses wherein the cessation of breastfeeding increases gut microbiome diversity in the infant, and a criterion for the developmental phases according to the month of age is 15 and 31 months [p. 584, col. 1, par. 2- p. 585, col. 1, par. 1, and figure 2].
B. Claims 13 and 17-21 are rejected under 35 U.S.C. 103 as being unpatentable over Stewart in view, as applied to claims 1-7, 11 as above, and in further view of Garcia-Rodenas et al (US 2018/0280454 A1, published 06/27/2017, cited on IDS dated 12/09/2021).
Claim 13 is directed to the method of claim 1, wherein the biomarker characteristic of the balance group for each developmental stage in step (D) is at least one selected from the group consisting of the microbes listed in Tables 29 to 32 and the biomarker characteristic of the imbalance group for each developmental stage is at least one selected from the group consisting of the microbes listed in Tables 33 to 36.
Stewart discloses wherein, before four years of age, the gut microbiome undergoes three distinct phases; and the phases are most affected by food eaten, Bifidobacterium is abundant in the early developmental phase, and after cessation of breastfeeding, Firmicutes gradually increases and remains stable [abstract; p. 587, col. 1, par. 1, and figure 3], but is silent on which microbes constitute the balance and imbalance groups.
However, Garcia-Rodenas discloses Lactobacillus reuteri for use in the prevention or treatment of microbiota dysbiosis, in particular , decreased levels of Actinobacteria and increased levels of Proteobacteria, in young mammals and in the prevention or treatment of disorders associated therewith [abstract]. Garcia-Rodenas further discloses a method for recovery of microbiota dysbiosis in a young mammal, wherein Bifidobacteria accounts for 30% to 50% of total bacteria in a healthy, vaginally-delivered, breast-fed infant, and Escherichia is observed in infants born by cesarean section [0004] and [0008].
Claim 17 is directed to the method of claim 1, further comprising a step of monitoring a change of imbalance determination index in the test infant with time, after the step of (D).
Stewart is silent on monitoring the change of imbalance.
However, Garcia-Rodenas discloses delivery by C - section induced important changes in the global microbiota profile and taxa levels in the control group , especially 2 weeks after birth , but still detectable at 4 months of age [0120].
Claim 18 is directed to the method of claim 1, further comprising a step of achieving a gut microbial balance by conducing at least one measure selected from the group consisting of prebiotics, probiotics, medication, diets, and life habits on the basis of the developmental stage of gut microbiota and the degree of gut microbiota dysbiosis in the test infant.
Stewart is silent on changing a selected measurement.
However, Garcia-Rodenas discloses that the administration of Lactobacillus reuteri prevents or treats microbiota dysbiosis and disorders associated therewith [claim 1 and [0062]].
Claim 19 is directed to the method of claim 18, wherein the probiotics include at least one microbial biomarker characteristic of the balance group of developmental stage 1 as shown in Tables 29 and 30, when the test infant is determined to be in developmental stage 1, and at least one microbial biomarker characteristic of the balance group of developmental 2 as shown in Tables 31 and 32, when the test infant is determined to be in developmental 2, in case that the developmental stages of the test infant are divided into developmental stage 1 and developmental stage 2.
Stewart is silent on the balance and imbalance groups.
However, Garica-Rodenas discloses wherein the fecal microbiota of a healthy, vaginally-delivered, breast-fed infant of age 2 to 6 months is generally dominated by Bifidobacteria, microbiota dysbiosis may be induced by C-section delivery, and C-section infants have increased levels of C. difficile [[0003], [0008], and [0101]]. This limitation could easily be derived by a person skilled in the art from the features of Garcia-Rodenas.
Claim 20 is directed to the method of claim 18, wherein in case that the developmental stages of the test infant are divided into developmental stage 1 and developmental stage 2, when the test infant is determined to be in developmental stage 1, the prebiotics include a material increasing a relative abundance of at least one of the microbial biomarkers characteristic of the balance group of developmental stage 1 as listed in Tables 29 and 30, or a material decreasing a relative abundance of at least one of the microbial biomarkers characteristic of the imbalance group of developmental stage 1 as listed in Tables 33 and 34, or when the test infant is determined to be under developmental stage 2, the prebiotics include a material increasing a relative abundance (relative abundance ratio) of at least one of the microbial biomarkers characteristic of the balance group of developmental stage 2 as listed in Tables 31 and 32, or a material decreasing a relative abundance of at least one of the microbial biomarkers characteristic of the imbalance group of developmental stage 2 as listed in Tables 35 and 36.
Stewart is silent on the balance and imbalance groups.
However, Garica-Rodenas discloses wherein the fecal microbiota of a healthy, vaginally-delivered, breast-fed infant of age 2 to 6 months is generally dominated by Bifidobacteria, microbiota dysbiosis may be induced by C-section delivery, and C-section infants have increased levels of C. difficile [[0003], [0008], and [0101]]. This limitation could easily be derived by a person skilled in the art from the features of Garcia-Rodenas.
Claim 21 is directed to the method of claim 1, wherein, in step (D), the balance group of developmental stage 1 is a group in which a biomarker characteristic of the balance group influenced by natural delivery and breastfeeding is detected, the imbalance group of developmental stage 1 is a group in which a biomarker characteristic of the imbalance group influenced by diarrhea and antibiotic administration, the balance group of developmental stage 2 is a group in which a biomarker characteristic of the balance group influenced by natural delivery is detected, and the imbalance group of developmental stage 2 is a group in which a biomarker characteristic of the imbalance group influenced by diarrhea and antibiotic administration.
Stewart is silent on the balance and imbalance groups.
However, Garica-Rodenas discloses wherein the microbiota of an infant born by a vaginal delivery is a normal microbiota population, and microbiota dysbiosis is caused by exposure to antibiotics during delivery or after birth and by gastrointestinal dysfunctions (diarrhea) [0010] and [0125].
In regards to claim(s) 13 and 17-21, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Stewart with Garcia-Rodenas as they both are directed to prevention or treatment of microbiota dysbiosis, in young mammals and in the prevention and treatment of disorders associated therewith. The motivation would have been to modify the groupings of Stewart to include the balance and imbalance groups of Garcia-Rodenas to provide treatment of microbiota dysbiosis, includes reestablishing a microbiota not significantly different from that observed healthy young mammals , who are not experiencing microbiota dysbiosis. This means that the various bacterial populations are re-established in their optimal relative abundance as disclosed by Garcia-Rodenas [0017].
Conclusion
No claims are allowed.
Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Dawn M. Bickham whose telephone number is (703)756-1817. The examiner can normally be reached M-Th 7:30 - 4:30.
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/D.M.B./Examiner, Art Unit 1685
/Soren Harward/Primary Examiner, TC 1600