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
This Office Action is in response to Applicants’ Amendment and Remarks filed on 1/27/2026 in which claims 1-13 are amended. No claims are newly added or canceled.
Claims 1-13 are pending in the instant application and are examined on the merits herein.
Priority
This application is a National Stage Application of PCT/EP2021/081150, filed on 11/9/2021. The instant application claims foreign priority to EP 20200658305 filed on 11/10/2020. Acknowledgment is made of applicant's claim for foreign priority under 35 U.S.C. 119(a)-(d). The certified copy has been filed in the instant application on 5/8/2023.
Withdrawn Objection
Applicant’s amendment, filed on 1/27/2026, with respect to the objection of dependent claims for reciting “A method of claim…”, has been fully considered and is persuasive. Applicant amended the claims to properly recite, “The method of claim…” for all dependent claims. The objection is hereby withdrawn.
Withdrawn Rejections
Applicant’s amendment, filed on 1/27/2026, with respect to the rejection of claims 1-13 under 35 U.S.C. 112(a), has been fully considered and is persuasive. Applicant amended the claims to remove recitations directed to a method of prevention. The rejection is hereby withdrawn.
Applicant’s amendment, filed on 1/27/2026, with respect to the rejection of claim 5 under 35 U.S.C. 112(b), has been fully considered and is persuasive. Applicant amended the claims to the phrases associated with “preferably”. The rejection is hereby withdrawn.
Maintained Rejections
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 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 of this title, 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.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1-12 are rejected under 35 U.S.C. 103 as being unpatentable over Chow et al. (US 2012/0171166A1, reference of record).
Chow et al. discloses a method for treating gastrointestinal diseases/disorders, specifically food allergies and colitis, by administering to an infant or toddler a synthetic pediatric formula comprising a probiotic, a first oligosaccharide in a concentration of from about 1 mg/mL to about 4 mg/mL and selected from the group consisting of galactooligosaccharide, fructooligosaccharide, and combinations thereof; and a second oligosaccharide in a concentration of from about 0.05 mg/mL to about 0.5 mg/mL and selected from the group consisting of 2'-fucosyllactose, 3'-fucosyllactose, 3'-sialyllactose, 6'-sialyllactose, lacto-N-neotetraose, and combinations thereof. (Claim 10) Chow also discloses that particularly suitable nutritional compositions include at least one of the following HMOs or HMO precursors: sialic acid (SA); 2'-Sialyllactose (2'SL); 3'-Sialyllactose (3'SL); 6'-Sialyllactose (6'SL); 2'-Fucosyllactose (2'FL); 3'-Fucosyllactose (3'FL); and Lacto-N-tetraose (LNT) and Lacto-N-neotetraose (LNnT), and in particular, combinations of 2'FL with at least one of 6'SL and 3'SL; and combinations of LNnT with at least one of 6'SL and 3'FL. (¶0062) Chow envisions the HMO combination 3’-SL, 6’SL, 3’FL, 2’FL and LNnT. (¶0063)
Chow further discloses that the pediatric formula may be in the form of nutritional liquids, nutritional powders, nutritional semiliquids, nutritional semi-solids (e.g. puddings, gelatins, and doughs), nutritional supplements, liquid and powdered dietary supplements, liquid and powdered human milk fortifiers, liquid and powdered preterm infant formulas, liquid and powdered infant formulas, liquid and powdered elemental and semi-elemental formulas, liquid and powdered pediatric formulas, liquid and powdered toddler formulas, liquid and powdered follow-on formulas, liquid, powdered and solid adult nutritional formulas and any other nutritional food product as known in the art. (¶0026-0030, 0051) Chow further teaches that the total amount of HMOs in the pediatric formula ranges from 0.001-15 mg/mL or 0.0005% to about 5% (¶0064-0065) and that each individual HMO can be present in a range of 0.001-20 mg/mL. (¶0069-0074) Chow also teaches that the pediatric formula comprises proteins at 0.5-30% (including extensively hydrolyzed protein), carbohydrates at 5-40% and fat at 1-30%. (¶0094, 0109-0110)
With respect to the limitation regarding the claimed method treating disorders associated with an above-normal number of granulocytes in a tissue and/or degranulation of granulocytes, and/or interleukin IL-5 mediated diseases, this limitation is considered met by Chow because Chow teaches treating food allergies. Dependent claim 12 lists food allergies as a disorder that classifies as “disorders associated with an above-normal number of granulocytes in a tissue and/or degranulation of granulocytes, and/or interleukin IL-5 mediated diseases”.
Chow does not exemplify or claim the HMO combination of 3’-SL, 3’FL, 2’FL and LNnT or the HMO combination 3’-SL, 6’SL, 3’FL, 2’FL, LNT and LNnT.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the specific combination of 3’-SL, 3’FL, 2’FL and LNnT or 3’-SL, 6’SL, 3’FL, 2’FL, LNT and LNnT, would reasonably be expected to be effective in the method of Chow, thereby arriving at the instant invention. Chow broadly claims that food allergies may be treated by administering any combination of 2'-fucosyllactose, 3'-fucosyllactose, 3'-sialyllactose, 6'-sialyllactose, lacto-N-neotetraose. In addition, Chow envisions that the specific combination of 3’-SL, 6’SL, 3’FL, 2’FL and LNnT would be therapeutically effective. Thus, selecting this specific combination from within the genus of combinations claimed by Chow would be prima facie obvious. Chow also teaches that LNT is particularly suitable in the therapeutic composition. Hence, it would be obvious to add LNT to the combination of 3’-SL, 6’SL, 3’FL, 2’FL and LNnT, to yield the combination 3’-SL, 6’SL, 3’FL, 2’FL, LNT and LNnT.
With respect to the limitations regarding amounts of individual HMOs in the nutritional composition or the amount of protein, carbs and fat, the claimed ranges overlap with what is disclosed by Chow. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). (MPEP § 2144.05(I)) Moreover, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). (MPEP § 2144.05(II)) “The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.” In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003).
Accordingly, the instant claims are prima facie obvious over the teachings of the prior art.
Response to Arguments
Applicants’ response with respect to the obviousness rejection over Chow, has been fully considered but is not persuasive.
Applicant argues that Chow does not teach treating “disorders associated with an above-normal number of granulocytes in a tissue and/or degranulation of granulocytes, and/or interleukin IL-5 mediated diseases”. Applicants’ argument is not persuasive because Chow teaches treating food allergies, which by definition according to instant claim 5, is a condition that is among “disorders associated with an above-normal number of granulocytes in a tissue and/or degranulation of granulocytes, and/or interleukin IL-5 mediated diseases”. Thus, in treating food allergies, Chow will necessarily meet the claimed limitation regardless of whether or not Chow recognized the mechanism of action with respect to granulocytes or IL-5.
Applicant argues that the data in the specification presents evidence of unexpected results, which overcomes a prima facie case of obviousness. Specifically Applicant argues that Figures 1 and 2 of the specification show that the claimed combination of 4 or 6 HMOs is superior at stabilizing granulocytes or reducing IL-5 production, relative to individual HMOs or a binary mixture of HMOs. Applicants’ argument is not persuasive because Figure 1 shows that “Mix-2”, “Mix-4” and “Mix-6” are all equally effective at reducing IL-5 production, within statistical error. Thus, there is no persuasive evidence that the claimed combination of 4 or 6 HMOs is superior, relative to a binary mixture of HMOs. Applicants’ argument is not persuasive because Figure 2A shows that, within statistical error, only the 6 HMO mixture is superior at stabilizing granulocytes, when compared to individual HMOs. The 4 HMO mixture is equivalent to the performance of individual HMOs. The instant claims recite the 4 HMO mixture, so are not commensurate in scope with the purported unexpected results.
Applicant argues that Chow does not teach a 3’SL concentration range of 2-15 wt% relative to all HMOs, indeed Chow teaches that 3’SL is present at 85-100 wt% relative to all HMOs. Applicants’ argument is not persuasive because the section of Chow reciting 3’SL is present at 85-100 wt% relative to all HMOs, begins with “In one embodiment”, which does not limit the entire disclosure of Chow, but provides one envisioned narrower embodiment of what is more generally taught and suggested by Chow. Specifically, Chow teaches each individual HMO can be present in a range of 0.001-20 mg/mL. Given this general teaching of Chow, it would have been prima facie obvious to arrive at the claimed 3’SL amount by routine optimization.
Applicant argues that the citation of Chow for administering a combination of 4 or 6 HMOs involves impermissible hindsight because the Examples of Chow only teach administering individual HMOs or a mixture of 2 HMOs. Applicants’ argument is not persuasive because Chow envisions a mixture of 4 or 6 HMOs, identical to that claimed at ¶0063. The lack of a 4 or 6 HMO mixture in the exemplified embodiments of Chow, does not mean that one is prohibited from looking to Chow as a whole to determine what may be more broadly taught and suggested. Because Chow suggests a 4 or 6 HMO mixture means it would be reasonable for POSITA to expand upon the exemplified embodiments of Chow and employ these mixture in the method of Chow.
The rejection is still deemed proper and is maintained.
Claims 1-13 are rejected under 35 U.S.C. 103 as being unpatentable over Chow et al. (US 2012/0171166A1, reference of record), in view of Blanchard et al. (US 2019/0054165 A1, reference of record), farther in view of Vigsnaes et al. (US 2016/0243139 A1, reference of record).
The disclosure of Chow is referenced as discussed above. Chow does not teach treatment of eosinophilic esophagitis, eosinophilic gastritis, eosinophilic gastroenteritis, or eosinophilic colitis. Chow also does not teach the correlation between HMO administration and modulation of mast cells (a.k.a. granulocytes).
Blanchard et al. discloses a method for treating allergy by administering a combination of 2’-FL and LNnT, where allergy includes allergic sensitization, food allergy, atopic dermatitis and eczema, wheezing, asthma, allergic rhinitis, rhino-conjunctivitis, eosinophilic esophagitis, hypersensitivity, anaphylaxis, urticaria. (Claim 12; Col. 5, Ln. 6-15)
Vigsnaes et al. discloses that it has been surprisingly found that human milk monosaccharides (HMSs) and/or human milk oligosaccharides (HMOs) are able to modulate the gut microbiota, stabilize mast cells and hereby prevent symptoms in patients suffering from visceral pain. HMSs and/or HMOs preferentially increase the abundance of beneficial bacteria, such as bifidobacteria, and regulate immune responses causing a decrease in the degranulation and activation of mast cells. Furthermore, HMSs and/or HMOs act to repair damage in the mucosal barrier and act on neuronally dependent gut migrating motor complexes to address disorders of gut motility and possibly have beneficial effects on the central nervous systems of patients. (¶0025) Vigsnaes exemplifies that administration of 2’-FL and LNnT acts to modulate the intestinal microbiota, and specifically stimulate the abundance of bifidobacteria. The blood biomarker analysis indicates that the treatment patients have reduced levels of inflammatory markers, and reduced release of mast cell mediators meaning stabilization of mast cells. Reduction in visceral pain and an improvement in bowel movement are reported by treatment patients as compared to the placebo group. Collectively, HMOs are able to increase bifidobacteria and stabilize mast cells, and hereby contribute to improvement in visceral pain in IBS patients. (Example 1)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the method of Chow would also be expected to be effective to treat allergies beyond food allergies, including allergic sensitization, atopic dermatitis, eczema, wheezing, asthma, allergic rhinitis, rhino-conjunctivitis, eosinophilic esophagitis, hypersensitivity, anaphylaxis, urticaria, thereby arriving at the instant invention. The method of Blanchard treats the aforementioned allergic conditions by administering 2’-FL and LNnT. Since a composition, for treating food allergies, comprising 3’-SL, 6’SL, 3’FL, 2’FL and LNnT is taught by Chow and this composition contains 2’-FL and LNnT, the envisioned composition of Chow would reasonably be expected to be effective for treating other allergic conditions such as eosinophilic esophagitis, based on the teaching of Blanchard.
Moreover, it would have been obvious that the mechanism of action of the anti-allergy method of Chow/Blanchard, at least in part, would involve a decrease in the degranulation and activation of mast cells, based on the teaching of Vigsnaes. Vigsnaes teaches that the combination of 2’-FL and LNnT decreases the degranulation and activation of mast cells. Since the therapeutic composition of Chow/Blanchard contains 2’-FL and LNnT, one would reasonably expect decreases the degranulation and activation of mast cells to accompany the anti-allergy effect of the method of Chow/Blanchard.
Accordingly, the instant claims are prima facie obvious over the teachings of the prior art.
Response to Arguments
Applicant argues that the combined prior art does not render the independent claims prima facie obvious for the reasons outlined above, thus the rejection of dependent claims that reply on the teachings of said combined prior art, should be withdrawn. Applicants' arguments are not persuasive because the rejection of the independent claims is maintained as prima facie obvious over said combined prior art, as per the response to arguments above.
The rejection is still deemed proper and is maintained.
Rejections/Objections Necessitated by Amendment
The following are new ground(s) or modified rejections/objections necessitated by Applicants' amendment, filed on 1/27/2026, wherein claim 5 is amended. Therefore, new grounds of rejection/objection have been made.
New Objection
Claim 5 is objected to for the typographical error, “claim 1--er-±”. Appropriate correction is required.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new and/or modified 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 mailing date of this final action.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to DALE R MILLER whose telephone number is (571) 272-6146. The examiner can normally be reached on M-F 7:00 AM – 3:30 PM EST.
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/DALE R MILLER/Primary Examiner, Art Unit 1693