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
Pursuant to the preliminary amendment dated 4/13/2023, claims 1-13 and 15 are amended. No claims are newly added or canceled.
Claims 1-15 are pending in the instant application and are examined on the merits herein.
Priority
This application is a National Stage Application of PCT/EP2021/077653, filed on10/7/2021. The instant application claims foreign priority to EP 20202262.0 filed on 10/16/2020. 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 4/13/2023.
Information Disclosure Statement
The information disclosure statements (IDS) dated 4/13/2023, 10/18/2023 and 3/6/2025 comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609, except where noted. Accordingly, the IDS documents have been placed in the application file and the information therein has been considered as to the merits.
Claim Objection
Claim 1 is objected to for a grammatical error, the recitation “a human milk oligosaccharides (HMOs)” should be “human milk oligosaccharides (HMOs)”.
Claim 2 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 1. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 706.03(k).
Claims 2-4, 7 and 9-13 are objected to for improper preamble wording. Since claims 2-4 and 6-13 depend on base claim 1 the preamble “A method according to claim 1…” is improper and should be “The method according to claim 1…”.
Claim 8 is objected to for reciting “A according to claim 1…” which is improper and should be “The method according to claim 1…”.
Claim 15 is 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 § 102
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 –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 14 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schroven et al. (US 2015/0183814A1, PTO-892).
Schroven et al. discloses a nutritional composition comprising the following HMOs: (Example 5; ¶0040)
HMO
Weight
Wt% of HMOs
2'-FL
3.38 g
50
3-FL
0.87 g
12
LNT
1.20 g
17
LNnT
0.35 g
5.1
3'-SL
0.27 g
4.0
6'-SL
0.72 g
11
With respect to the transitional phrase "consisting essentially of" limits the scope of a claim to the specified materials or steps "and those that do not materially affect the basic and novel characteristic(s)" of the claimed invention. In re Herz, 537 F.2d 549, 551-52, 190 USPQ 461, 463 (CCPA 1976) (emphasis in original). However, for the purposes of searching for and applying prior art under 35 U.S.C. § 102 and 103, absent a clear indication in the specification or claims of what the basic and novel characteristics actually are, "consisting essentially of" will be construed as equivalent to "comprising." See, e.g., PPG, 156 F.3d at 1355, 48 USPQ2d at 1355. (see also MPEP § 2111.03) In the instant case, there is no clear indication either in the specification or in the claims, which components are excluded, in order to aid in determining the scope of the phrase "consisting essentially of". Therefore, the teachings of the cited prior art are within the scope of the instant claims.
Accordingly, the instant claims are anticipated by the prior art.
Claim 14 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jennewein et al. (US 2020/0384041A1, June 2020, PTO-892).
Jennewein et al. discloses a nutritional composition comprising the following HMOs: (¶0084)
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258
341
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Jennewein further discloses that the above HMO mixture may be part of a nutritionally complete formula as follows: (¶0114)
PNG
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543
343
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PNG
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131
342
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With respect to the transitional phrase "consisting essentially of" limits the scope of a claim to the specified materials or steps "and those that do not materially affect the basic and novel characteristic(s)" of the claimed invention. In re Herz, 537 F.2d 549, 551-52, 190 USPQ 461, 463 (CCPA 1976) (emphasis in original). However, for the purposes of searching for and applying prior art under 35 U.S.C. § 102 and 103, absent a clear indication in the specification or claims of what the basic and novel characteristics actually are, "consisting essentially of" will be construed as equivalent to "comprising." See, e.g., PPG, 156 F.3d at 1355, 48 USPQ2d at 1355. (see also MPEP § 2111.03) In the instant case, there is no clear indication either in the specification or in the claims, which components are excluded, in order to aid in determining the scope of the phrase "consisting essentially of". Therefore, the teachings of the cited prior art are within the scope of the instant claims.
Accordingly, the instant claims are anticipated by the prior art.
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 1-3, 7, 9-11, 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over McConnell et al. (US 11,602,545 B2, June 2019, PTO-892), as evidenced by Akdis et al. (J. Clin. Invest., 2014, PTO-892).
McConnell 545 discloses a method for treating autoimmune disease, irritable bowel syndrome, an allergy, and/or a food intolerance by administering a nutritional supplement composition comprising, consisting of, or consisting essentially of fucosylated HMOs, neutral HMOs and/or acidic HMOs, specifically where the HMO mixture of 2'-FL, 3-FL, DFL, LNT, LNnT, 3'-SL, 6'-SL and LNFP-I is taught. (Col. 12, Ln. 1-45, Col. 5, Ln. 52-55; Example 2) McConnell further discloses that the composition may comprise lipids (at 35-50% total energy), carbohydrates (at 35-55% total energy) and extensively hydrolyzed protein (or free amino acids) at 5-30% total energy. (Col. 12, Ln. 36-67, Col. 13, Ln. 1-25)
Akdis et al. discloses that autoimmune diseases, allergies and tolerance to allergens are mediated by IL-10. (p. 4679) Thus, the diseases treated by McConnell 545 are IL-10 mediated diseases, as per Akdis.
McConnell 545 does not exemplify or claim an HMO mixture of 2'-FL, 3-FL, LNnT and 3'-SL.
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 treating the IL-10 mediated diseases selected from autoimmune disease, an allergy, and/or a food intolerance could be modified to specifically administer an HMO composition comprising, consisting of, or consisting essentially 2'-FL, 3-FL, DFL, LNT, LNnT, 3'-SL, 6'-SL and LNFP-I, thereby arriving at the instant invention. One would be motivated to modify McConnell 545 in this manner because McConnell 545 specifically suggests such an HMO mixture.
Accordingly, the instant claims are prima facie obvious over the teachings of the prior art.
Claims 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over McConnell et al. (US 11,602,545 B2, June 2019, PTO-892), as evidenced by Akdis et al. (J. Clin. Invest., 2014, PTO-892), further in view of Jennewein et al. (US 2020/0384041A1, June 2020, PTO-892).
The disclosures of McConnell 545, Akdis and Jennewein are referenced as discussed above. McConnell 545/Akdis does not teach the proportions of the disclosed HMOs in the mixture.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to look to analogous art for guidance on accepted proportions of the relevant HMOs expected to be useful in the nutritional compositions of McConnell 545/Akdis. The disclosure of Jennewein provides such guidance. Jennewein exemplifies percentages and concentrations of 2'-FL, 3-FL, DFL, LNT, LNnT, 3'-SL, 6'-SL and LNFP-I, where single percentages, as well as concentration ranges are provided in Tables 1 and 2. One of ordinary skill in the art would have a reasonable assurance of success that the amounts and ranges of each of the HMOs used in the method of McConnell 545/Akdis could be routinely adjusted based on the guidance in Jennewein, because both McConnell and Jennewein are directed to nutritional compositions comprising HMOs and McConnell is silent on HMO concentration details.
With respect to the concentration ranges in claim 5 and 6. The ranges overlap that of the prior art. 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.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over McConnell et al. (US 11,602,545 B2, June 2019, PTO-892), as evidenced by Akdis et al. (J. Clin. Invest., 2014, PTO-892), further in view of Chichlowski et al. (US 2018/0333426A1, PTO-892).
The disclosures of McConnell 545, Akdis are referenced as discussed above. McConnell 545/Akdis does not teach total concentration of HMOs in microgram/ml.
Chichlowski et al. discloses nutritional compositions comprising HMOs where the concentrations of HMOs in the composition are in the range 0.5 mg/ml to 10 mg/ml (i.e. 500 to 10,000 µg/ml). (¶0006)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to look to analogous art for guidance on accepted concentrations of total HMOs expected to be useful in the nutritional compositions of McConnell 545/Akdis. The disclosure of Chichlowski provides such guidance.
With respect to the concentration ranges in claim 8. The ranges overlap that of the prior art. 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.
Conclusion
No claims are allowed.
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