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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 7/17/2026 has been entered.
Claim Objections
Claims 22 and 27 are objected to because of the following informalities:
Regarding claim 22, in line 2 insert “wt%” after “1.13” for consistency.
Regarding claim 27, in line 3 insert “the” before “urease negative” for consistency.
In line 3 amend “improves” to recite “improve” to place the limitation in better form.
In lines 4-5 amend “the non-digestible oligosaccharides and the urease positive” to instead recite “the non-digestible oligosaccharides, the urease positive”.
In line 5 insert “the” before “urease negative.”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 25 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
The claim recites an inherent property of the composition i.e., “synergistically stimulate the growth of intestinal Bifidobacteria”. A compound and it’s properties are inseparable In re Papesch, 315 F.2d 381, 391, 137 USPQ 43, 51 (CCPA 1963). Therefore, the claim recites said inherent property without further limiting the composition.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
Claims 1, 7-8, 22, 25 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Nutricia (WO 2017/043962 A1) in view of Wiklund (US 6,333,055 B1) and Buck et al. (US 8,802,650 A1). McCoy (US 5,116,737 A) is relied on as evidence for claims 25 and 27. Lee et al. “Genomic Insights into Bifidobaceria” is relied on as evidence for claim 1.
Regarding claim 1, Nutricia teaches a nutritional composition comprising digestible carbohydrates (page 11 line 33 to page 12 line 3), protein (page 11 lines 13-17), lipid (page 12 lines 4-5), and prebiotics (non-digestible oligosaccharides) selected from the group consisting of galacto-oligosaccharides and fructo-oligosaccharides (page 9 lines 7-9). The prebiotics are present in an amount of 0.05-20 wt% of the composition (page 9 lines 30-33). Nutricia further teaches the composition comprises B. longum spp infantis and B. breve (page 5 lines 24-25).
Lee et al. is relied on as evidence to show that B. longum spp infantis contains a “complete urease gene cluster” i.e., urease positive, while the gene cluster “is not present in any of the other bifidobacterial genome” and “all 9 strains of B. longum subsp. infantis produced urease and none of the others did” which indicates B. breve is urease negative (page 408 left column).
Regarding the nutritional composition being “an infant formula, a follow-on formula or a young child formula”, the limitation is interpreted in view of the specification to include ages up to 36 months (page 11 lines 23-32). Nutricia teaches the composition can be infant formula (column 11 lines 8-11).
Nutricia does not specify the prebiotics are present in an amount of 0.2-2 g per 100 ml.
However, the reference teaches the prebiotics are present in therapeutically effective amounts (page 9 line 30), and the overall content of the prebiotics within the composition can vary based on the type/application (page 10 lines 5-8). A supplement comprising 80 wt% of prebiotics in the total composition would have a concentration greater than a nutritional product comprising 20 wt% prebiotics. The reference further teaches that oligosaccharides stimulate growth of bifidobacterial and Lactobacilli, which confer benefits to the host wellbeing and health (page 8 lines 24-30).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the formula of Nutricia to comprise the claimed concentration of oligosaccharides since the reference already teaches varying oligosaccharide content, since the evidence of record does not indicate criticality or unexpected results associated with the feature, and since the values would have been used during the course of routine experimentation and optimization procedures due to factors such as therapeutic amount, stimulation of bifidobacterial and Lactobacilli, flavor, texture/mouthfeel, nutritional profile, characteristics of the consumer e.g., weight, age, size, sex, and volume of the composition e.g., a concentrated supplement or a composition diluted in water or milk.
Nutricia does not teach urea present in an amount of 15-75 mg per 100 ml.
Wiklund teaches urea as an additive to infant formula for prophylaxis of SIDS (abstract), the formula comprising varying amounts of urea based on age (column 4 line 64 to column 5 line 3; column 6 to column 7 examples 1-3). For example 1, the composition comprises 120 mg urea in about 1.2 L, which is about 10 mg per 100 ml. The amount is about 25 mg per 100 ml for example 2, and about 23 mg per 100 ml for example 3. The reference further teaches decomposition of urea occurs in the gastrointestinal tract by urease-producing bacteria which gradually colonize the initially sterile intestine of the neonate. The bacterial colonization normally occurs during the first weeks of life but may be delayed, inhibited, or be insufficient in another way in the children which experience a respiratory insufficiency resulting in SIDS (column 2 lines 55-62). Issues include a defect in bacterial formation of ammonium ion from urea in the intestine (column 3 lines 65-66). Further, the method for prophylaxis includes administering to the gastrointestinal tract of the infant a urease-producing bacteria (column 4 lines 51-55), which suggests the two can be administered together.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the formula of Nutricia to include 15-75 mg per 100 ml urea since the prior art already acknowledges adding an amount of urea in the claimed range to infant formula and administering urease-producing bacteria, and therefore to similarly provide a sufficient amount for prophylaxis of SIDS, and since the claimed values would have been used during the course of routine experimentation and optimization procedures due to factors such as desired prophylactic effect, volume and type of the composition, and characteristics of the intended user e.g., weight, age, sex, etc.
Nutricia does not teach the composition further comprises 2’-fucosyllactose (2’FL).
Buck et al. teaches formulas comprising human milk oligosaccharides (HMO) that can reduce inflammation and thereby improve airway defense mechanisms and overall airway respiratory health in an infant, toddler or child (column 1 lines 16-23), where the HMO includes 2’FL (column 2 lines 20-21).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition of Nutricia to include 2’FL since the prior art acknowledges the substance can be included in nutritional formulas for infants, and therefore to provide the same advantages taught by Buck et al.
Regarding claim 7, Nutricia teaches the composition comprises no more than 2 g protein per 100 kcal (page 11 lines 13-14).
Regarding claim 8, the claim is interpreted to recite alternatives, separated by the term “or”. For the sake of examination, the alternative “cow milk proteins” is chosen. Nutricia teaches the composition comprises cow milk proteins, which are considered to provide the minimum requirements for essential amino acid content for satisfactory growth (page 11 lines 18-22).
The reference does not teach the composition comprising at least 90 wt% cow milk proteins based on total protein.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition of Nutricia to have the claimed weight percentage based on total protein since the reference already teaches cow milk proteins are preferred, since there is no evidence of criticality or unexpected results associated with the claimed feature, and since the claimed values would have been used during the course of routine experimentation and optimization procedures due to factors such as amino acid profile and minimum protein requirements for satisfactory growth.
Regarding claim 22, the combination applied to claim 1 does not teach 1.13-5.6 wt% urea based on total protein in the composition.
Nutricia further teaches adjusting the amount of protein based on desired fraction of total calories and minimum requirements for essential amino acid for growth (page 11 lines 15-19), where the formula can comprise at least 3 wt% casein based on dry weight.
With respect to urea content of the combination, Wiklund further teaches the urea can be added in varying amounts to obtain concentrations of 1-5 mmol/L for an infant during the first month of life (column 5 lines 19-22), and 1-10 mmol/L for a child during months 2-7 of life (column 5 lines 27-29).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the formula of Nutricia to include urea in the claimed weight percentage based on total protein in the composition since the reference acknowledges adjusting protein content, and Wiklund teaches adjusting urea concentration, where the urea concentration is increased based on age, and therefore since the claimed values would have been used during the course of routine experimentation and optimization procedures due to factors such as requirements for growth, age, and prophylaxis of SIDS.
Regarding claim 25, Nutricia teaches a nutritional composition comprising urea and non-digestible oligosaccharides in the respective amounts, as well as the claimed Bifidobacteria. The composition comprising 2’ fucosyllactose is obvious in view of the combination applied to claim 1. The combination does not teach that the two components “synergistically stimulate growth of intestinal Bifidobacteria”.
Applicant’s specification states that “a symbiotic, improved or synergistic effect is to be expected from urea together with non-digestible oligosaccharides”, where this effect is achieved by urease-positive Bifidobacteria that “will beneficially affect the growth of other Bifidobacterium strains that are urease negative, by producing the growth factor CO2 and by releasing ammonium as nitrogen source. This released CO2 and ammonia can then be used by urease negative Bifidobacteria resulting in a more diverse and further improved microbiota.” (page 19 lines 5-12). The limitation in question is interpreted in view of the cited disclosure.
Nutricia teaches non-digestible oligosaccharides are fermented by intestinal microbiota of the infant, thereby stimulating growth of Bifidobacteria and Lactobacilli, and in turn stimulating healthy intestinal microbiota (page 8 lines 24-30). The reference further teaches bifidobacterial colonization of gut of C-section infants is desirable, and colonization of at least one Bifidobacterium species promotes intestinal colonization of other species (page 6 line 31 to page 7 line 6). It is further desirable to improve and/or accelerate developing the appropriate bifidobacterial population and Bifidobacterium species in infants, where improving gastrointestinal Bifidobacterium population and diversity of species provides multiple health benefits (page 4 lines 12-28). Thus, the reference suggests that colonization of the gut with at least one urease-positive Bifidobacterium species would facilitate proliferation and colonization of other urease-negative bacterium naturally present within the gut. It is noted that the motivation for incorporating urea into the composition of Nutricia is to provide prophylaxis of SIDS as stated for claim 1.
McCoy teaches a method for growing urease-producing (urea metabolizing) bacteria in a medium containing urea, the urease-producing bacteria including Bifidobacterium, where ammonia and carbon dioxide produced by hydrolysis of urea neutralizes the acid produced in the culturing, thereby allowing for a higher pH to be maintained to facilitate “rapid bacterial culture and high bacteria activity” (column 3 lines 12-27). The ammonia produced by urea hydrolysis limits pH drop in the growth medium and facilitates maintaining the pH in a range that promotes growth of the bacteria (column 3 lines 49-53). The reference shows that the process disclosed by Applicant, with respect to hydrolysis of urea into ammonium and carbon dioxide to facilitate Bifidobacterium growth, is expected by the prior art.
The combination applied to claim 1 teaches a nutritional composition comprising the claimed components, where the claimed amounts of each component are directly taught by, or rendered obvious by the prior art. The growth promoting effect of each component would have been expected to be synergistic when combined since said components are recognized to contribute to an optimized environment for Bifidobacteria growth (i.e., as metabolites and pH adjusters), where optimization of multiple environmental parameters would have synergistically promoted intestinal bacteria proliferation over that of a single parameter, with a reasonable expectation of success. This is particularly since Applicant discloses “a symbiotic, improved or synergistic effect is to be expected from urea together with non-digestible oligosaccharides”. Additionally, the data disclosed by the specification is not sufficient to show unexpected results (see response to arguments in the Non-Final rejection of 9/17/2025).
Regarding claim 27, the combination applied to claim 1 teaches the claimed limitations and a synergistic effect with respect to stimulating growth of intestinal Bifidobacteria is to be expected as stated for claim 25. One of ordinary skill would have similarly expected the composition of the prior art combination to stimulate growth of microbiota compared to a composition that does not comprise the claimed components for the same reasons stated for claim 25.
Response to Arguments
Upon further consideration, claim 25 is rejected under 35 USC 112(d) as failing to further limit the subject matter of claim 1, which recites urea and non-digestible oligosaccharides. Claim 25 is directed to only the inherent property of the compound.
Applicant's arguments filed 7/17/2026 have been fully considered but they are not persuasive.
Applicant submits further evidence (tables 1-2 pages 6-8) to show unexpected results associated with the claimed composition and criticality of urea content for growth of Bifidobacterium strains.
Examiner appreciates applicant’s effort to provide further supporting evidence. However, the evidence must be submitted in the form of a declaration or affidavit, see MPEP 716.01(c) I.-III. Regardless, it initially appears the data is insufficient to establish unexpected results and criticality of the claimed range of urea content.
Regarding the alleged synergistic effect of Bifidobacteria growth, the effect appears to be expected. Applicant’s specification states the synergistic effect is achieved by urease-positive Bifidobacteria that “will beneficially affect the growth of other Bifidobacterium strains that are urease negative, by producing the growth factor CO2 and by releasing ammonium as nitrogen source. This released CO2 and ammonia can then be used by urease negative Bifidobacteria resulting in a more diverse and further improved microbiota.” (page 19 lines 5-12). McCoy shows urease positive Bifidobacteria hydrolyzes urea into ammonia and carbon dioxide which in turn promotes growth of bacteria. Likewise, Wiklund teaches administering both urea and urease-positive bacteria to the gastrointestinal track of an infant for prophylaxis of SIDS. This is the same mechanism disclosed by applicant, and would have been expected to naturally occur in the presence of urea and conditions suitable for Bifidobacteria growth. The references are analogous since they are directed to growth of Bifidobacteria in foods and addresses the mechanism by which the bacteria and urea interact. Nutricia already teaches the composition comprises urease positive B. longum spp infantis and urease negative B. breve (page 5 lines 24-25). Since the prior art combination modifies Nutricia to include urea in amounts within the claimed range (e.g., 23 and 25 mg urea per 100 ml composition), one of ordinary skill in the art would have expected the same mechanism to occur in the infant gut when the modified composition is administered, where the ammonia and CO2 produced by the urease positive Bifidobacteria would be used by the urease negative Bifidobacteria for growth. See also MPEP 716.02(a) “a greater than additive effect is not necessarily sufficient to overcome a prima facie case of obviousness because such an effect can either be expected or unexpected. Applicants must further show that the results were greater than those which would have been expected from the prior art to an unobvious extent, and that the results are of a significant, practical advantage. Ex parte The NutraSweet Co., 19 USPQ2d 1586 (Bd. Pat. App. & Inter. 1991).”
Further, Nutricia teaches non-digestible oligosaccharides facilitate growth of desirable intestinal microbiota, where it is important to improve and/or accelerate developing the appropriate bifidobacterial population and Bifidobacterium species in infants, where improving gastrointestinal Bifidobacterium population and diversity of species provides multiple health benefits. Applicant’s specification states that “the best growth is observed only in the presence of a combination of non-digestible oligosaccharides as a carbon source and urea as both nitrogen and CO2 source” (page 19 lines 1-2). This indicates to one of ordinary skill that the observed synergistic result of Bifidobacterium growth is a direct product of said oligosaccharides and urea present within the composition. Since the prior art combination teaches an infant formula comprising the claimed substances in amounts within the claimed ranges, one of ordinary skill in the art would have reasonably expected a similar synergistic effect to be observed with the formula of the prior art combination. See also MPEP 716.02(c) II.
Regarding the criticality of the amount of urea being 20-60 mg per 100 ml composition, the evidence of record does not provide sufficient data with respect to urea content above the upper limit of the claimed range. Applicant states the specification discloses concentrations corresponding to 300 and 600 mg per 100 ml, and argues the disclosure supports criticality of the upper limit of the claimed range. However, the disclosed values are significantly above the upper limit of 60 mg per 100 ml. Based on the significant gap, one of ordinary skill in the art would not have been able to determine if the alleged results are observed only up to the claimed upper limit and no further.
Applicant argues McCoy is directed to aerobic conditions and provides no teaching or expectation regarding relative growth of a mixed population of urease-positive and urease-negative Bifidobacteria via cross-feeding, which is the effect of the present claims, and one of ordinary skill extrapolating McCoys findings to predict the synergistic effects in infant formula compositions requires hindsight analysis.
This is not persuasive since the cited prior art teaches that urease-positive B. longum spp infantis is recognized to hydrolyze urea to provide ammonia and carbon dioxide, which in turn promotes growth of other bacteria as stated above. Since B. breve is known to be urease-negative, and therefore cannot process urea, the hydrolysis of urea by B. infantis would be expected to facilitate growth of B. breve by providing the required nitrogen and carbon dioxide. The Bifidobacteria above are known to be present in anaerobic conditions of an infant, and growth is known to be desirable for infant health. While the prior art combination incorporates urea into the composition of Nutricia in amounts within the claimed range to provide the advantage of prophylaxis of SIDS, one of ordinary skill in the art would have expected similar synergistic growth of Bifidobacteria when the composition of the prior art combination is administered to an individual.
Nutricia teaches colonization of at least one Bifidobacterium species promotes intestinal colonization of other species (page 6 line 31 to page 7 line 6). It is further desirable to improve and/or accelerate developing the appropriate bifidobacterial population and Bifidobacterium species in infants, where improving gastrointestinal Bifidobacterium population and diversity of species provides multiple health benefits (page 4 lines 12-28). Thus, the reference suggests that colonization of the gut with at least one urease-positive Bifidobacterium species would facilitate proliferation and colonization of other urease-negative bacterium naturally present within the gut i.e., “cross-feeding”. The synergistic effect would have been expected as stated above.
Applicant argues the cited prior art does not teach or suggest selecting urea for, and combining with the claimed oligosaccharides and strains to achieve synergistic bacteria growth.
This is not persuasive since the result is expected as stated above, and since non-digestible oligosaccharides including galacto- and fructo-oligosaccharides are recognized by the prior art to be a carbon source for Bifidobacteria. Nutricia teaches non-digestible oligosaccharides facilitate growth of desirable intestinal microbiota, where it is important to improve and/or accelerate developing the appropriate bifidobacterial population and Bifidobacterium species in infants, where improving gastrointestinal Bifidobacterium population and diversity of species provides multiple health benefits.
Applicant argues the newly submitted data establishes urea below 10 mg per 100 ml is insufficient to sustain growth over extended periods whereas 20, 30, 50 and 60 mg per 100 ml provide progressive and sustained growth enhancement.
The data must be filed as an affidavit or declaration as stated above. Further, one of ordinary skill given said data would not be able to determine if the alleged result is not observed above 60 mg per 100 ml.
Applicant argues example 4 shows growth of Bifidobacteria is restored by a combination of 2’-fucosyllactose and urea, where the 2’-fucosyllactose serves as the carbon and energy source while urea provides nitrogen and generates carbon dioxide through urease activity, which represents a synergistic interaction between the two components, not merely an additive effect.
This is not persuasive since the example only indicates that the Bifidobacteria can use the oligosaccharide components as a carbon and energy source, which is known in the art. The data does not indicate to one of ordinary skill that the specific components of the example are critical and yield unexpected results.
Applicant argues Nutricia teaches a general observation about probiotics and does not teach the specific mechanism of urea metabolization to produce carbon dioxide and ammonia that serve as growth substrates for urease-negative Bifidobacteria.
This is not persuasive since the argued teaching is not required for one of ordinary skill to modify the composition of Nutricia. The suggestion and motivation are taught by the additional references i.e., prophylaxis of SIDS (Wiklund) and airway respiratory health (Buck) as stated for claim 1.
Regardless, Wiklund teaches decomposition of urea occurs in the gastrointestinal tract by urease-producing bacteria which gradually colonize the initially sterile intestine of the neonate, where issues with the process include a defect in bacterial formation of ammonium ion from urea in the intestine (column 2 lines 55-62; column 3 lines 65-66).
Applicant argues Examiner’s statement of expected synergistic effect constitutes hindsight since the statement appears in the context of inventors’ own work, where the specification expresses an expectation as to the direction of an effect, not the magnitude, and the cited prior art combination does not suggest the specific cross-feeding mechanism.
This is not persuasive for the same reasons stated above. Specifically, the prior art combination relies on teachings, suggestions, and motivations of the cited prior art alone i.e., prophylaxis of SIDS (Wiklund) and airway respiratory health (Buck). Applicant’s specification is cited to show that the claimed and argued features are an effect of the composition, and while said features are not explicitly disclosed by the cited prior art, said features would have been expected by the composition of the prior art combination.
Applicant argues example 4 of the specification demonstrates the combination of 2’-fucosyllactose and urea restores growth of urease-positive Bifidobacteria that would otherwise hardly grow, which Buck does not teach.
This is not persuasive for the same reasons stated above. The example only indicates that the Bifidobacteria can use the oligosaccharide components as a carbon and energy source, which is known in the art. The data does not indicate to one of ordinary skill that the specific components of the example are critical and yield unexpected results. Regardless, the motivation to modify Nutricia with the teachings of Buck is based on the benefits of airway respiratory health.
Applicant’s argument against the dependent claims is not persuasive for the same reasons stated above.
Conclusion
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/BRYAN KIM/Examiner, Art Unit 1792
