DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. The amendment filed April 13, 2026 has been received and entered.
3. Claims 15-31 are currently pending.
Election/Restrictions
4. Applicant’s election without traverse of the combination of beta-tocopherol, gamma-tocopherol, and delta-tocopherol for species A and 2’-fucosyllactose for species B in the reply filed on April 13, 2026 is acknowledged.
5. Claims 26 and 27 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
6. Claims 15-25 and 28-31 are examined on the merits.
Claim Rejections - 35 USC § 112
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
7. Claim 23 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 23 is indefinite because the phrase “wherein the oligosaccharide has three or more, and five or less, sugar residues” is confusing. It is unclear if the claim is requiring two oligosaccharides or if the claim is intending that the oligosaccharide has between three and five sugar residues.
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.
10. Claims 15-25 and 28-31 are rejected under 35 U.S.C. 101 because the claimed invention is directed to natural products without significantly more.
MPEP § 2106 sets forth the Subject Matter Eligibility Test to determine if a claim is directed to patent eligible subject matter. Step 1 asks if a claim is directed to a statutory category of invention. Applicant’s claims are directed to a product; thus, the answer to Step 1 is Yes.
The analysis then moves to Step 2A, Prong One, which asks if a claim recites to a product of nature. In this case, applicant’s claims recite a combination of beta-tocopherol, gamma-tocopherol, delta-tocopherol, and an oligosaccharide such as 2’-fucosyllactose. Claim 30 requires the addition of a Bifidobacteria strain. Beta-tocopherol, gamma-tocopherol, delta-tocopherol, and 2’-fucosyllactose are all naturally occurring compounds and Bifidobacteria is a naturally occurring bacteria. Thus, the claims do recite products of nature. MPEP § 2106.04(b) states that “When a claim recites a nature-based product limitation, examiners should use the markedly different characteristics analysis discussed in MPEP § 2106.04(c) to evaluate the nature-based product limitation and determine the answer to Step 2A.”
MPEP § 2106.04(c)(I) states that “if the nature-based product limitation is not naturally occurring, for example due to some human intervention, then the markedly different characteristics analysis must be performed to determine whether the claimed product limitation is a product of nature exception…”. To perform the markedly different characteristic analysis, MPEP § 2106.04(c)(II) states “The markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state. Markedly different characteristics can be expressed as the product’s structure, function, and/or other properties…”.
In this case, there is no indication that mixing the specified ingredients together as commensurate in scope with the stated claims changes the structure, function, or other properties of the ingredients in any marked way in comparison with the closest naturally occurring counterpart. The closest naturally occurring counterpart for each ingredient is the ingredient itself because each is found in nature. In addition, there is nothing to show that mixing the ingredients in the particular concentrations produces any sort of marked distinction. Thus, the claimed mixture as a whole does not display markedly different characteristics in comparison with the naturally occurring counterparts. Therefore, the answer to Step 2A, Prong One, is Yes.
Thus, the analysis must move to Step 2A, Prong Two, which asks if the claim recites additional elements that integrate the judicial exception into a practical application. As discussed in MPEP § 2106.04(d)(2) this evaluation is performed by identifying whether there are additional elements recited in the claim beyond the judicial exception and evaluating these additional elements to determine whether the claim as a whole integrates the exception into a practical application. In this case, applicant’s claims are directed to a composition with an intended use of promoting the growth of Bifidobacteria and as a formula. MPEP § 2106.04(d)(2) specifically states that a claim is only directed to “an intended use of a claimed invention or a field of use limitation, then it cannot integrate a judicial exception under the ‘treatment or prophylaxis’ consideration.” Therefore, applicant’s intended use is not sufficient to integrate the judicial exception into a practical application. Thus, the answer to Step 2A, Prong Two, is No.
Thus, the analysis must move to Step 2B which asks if claims recite additional elements that amount to significantly more than the judicial exception. MPEP § 2106.05 states that this evaluation is performed by “Evaluating additional elements to determine whether they amount to an inventive concept requires considering them both individually and in combination to ensure that they amount to significantly more than the judicial exception itself.” In this case, the additional element in the claims is the combination of the ingredients. However, MPEP § 2106.05(d) states that well-understood, routine, and conventional activities are not sufficient to show that the claims amount to significantly more than the judicial exception. Mixing specific compounds does not amount to significantly more than a combination of judicial exception because mixing compounds is well-understood, routine, and conventional in the field. Thus, mixing the ingredients together does not amount to significantly more than a combination of judicial exception because mixing compounds is well-understood, routine, and conventional in the field.
In addition, applicant’s intended uses are not considered to amount to significantly more. As discussed in MPEP § 2106.05(I)(A), “Generally linking the use of the judicial exception to a particular technological environment or field of use” is not considered to be enough to qualify as significantly more. An intended use of a claimed composition only generally links the exception to the field of use. Therefore, the additional elements are not considered to amount to significantly more. Thus, the answer to Step 2B is No. Consequently, the claims are not directed to patent eligible subject matter.
Claim Rejections - 35 USC § 102
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 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.
9. Claim(s) 15, 22-25 and 28-31 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chow (US 2012/0171166) with Laghari (Turk J Chem (2020) 44: 1694-1702) providing evidence of inherent characteristics of Chow.
Chow teaches a composition comprising 2’-fucosyllactose and soybean oil (see Examples 1-30). Soybean oil inherently contains beta-tocopherol, gamma-tocopherol, and delta-tocopherol as evidenced by Laghari (see Table 1). Thus, the composition taught by Chow contains a combination of beta-tocopherol, gamma-tocopherol, delta-tocopherol, and 2’-fucosyllactose. Chow also teaches that the composition promotes the growth of beneficial bacteria and contains a probiotic such as a Bifidobacteria. In addition, the reference teaches that the composition is formulated as an infant formula and can contain 0.1 to 5% of the oligosaccharide (see paragraphs 35, 65, 89 and claims 1 and 3).
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.
10. Claim(s) 15-25 and 28-31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Albrecht (US 2017/0354696) in view of Papas (US 2005/0209315).
Albrecht teaches an infant formula composition comprising 2’-fucosyllactose, Bifidobacteria, and a vitamin E ingredient containing alpha- and gamma-tocopherol (see paragraphs 2, 28 and the claims). The reference does not teach that the vitamin E ingredient specifically contains beta-tocopherol and delta-tocopherol.
However, Papas teaches that the bioavailability and absorption of vitamin E is improved if each of alpha-, beta-, delta-, and gamma-tocopherols are included in a vitamin E ingredient. The reference teaches that this is especially useful when creating infant formulas. The reference teaches using about 0.1 to about 5 weight percent beta-tocopherol, about 25 to about 50 weight percent gamma-tocopherol and about 5 to about 25 weight percent delta-tocopherol (see abstract, paragraphs 3, 5, 15, 24, and claim 10).
Thus, an artisan of ordinary skill in the art would reasonably expect that the nutritional value of the infant formula taught by Albrecht would be improved if beta-tocopherol and delta-tocopherol were added to the formula. The artisan would expect that the addition of beta-tocopherol and delta-tocopherol would improve the bioavailability and absorption of vitamin E in the formula as taught by Papas. This reasonable expectation of improvement would have motivated the artisan to modify Albrecht to include the addition of beta-tocopherol and delta-tocopherol to the composition.
The references do not specifically teach adding the ingredients together in the amounts claimed by applicant. However, as discussed in MPEP section 2144.05(II)(A), “Generally, 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).” Varying the concentration of ingredients within a pharmaceutical composition in and around the ranges taught in the references is not considered to be inventive unless the concentrations are demonstrated as critical. In this particular case, there is no evidence that the claimed concentrations of the ingredients produces an unexpected result. Thus, absent some demonstration of unexpected results from the claimed parameter, this optimization of ingredient concentration would have been obvious before the effective filing date of applicant’s claimed invention.
11. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Susan Hoffman whose telephone number is (571)272-0963. The examiner can normally be reached M-Th 8:30am - 5:00pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anand Desai can be reached at 571-272-0947. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SUSAN HOFFMAN/Primary Examiner, Art Unit 1655
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