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 .
Election/Restrictions
Applicant's election with traverse of group I, claims 1-12 in the reply filed on 20 November 2025 is acknowledged. The traversal is on the grounds that applicant asserts Austin does not teach the claimed composition. The mathematical calculations provided by applicant are not found persuasive. Applicant has not provided an evidentiary basis for the conversion of mg/kg to µg/mL. Nonetheless, the conversions provided do not demonstrate why the content of 2’FL (5.6-490 mg/100g) and 3FL(4.7-280 mg/100g) in Austin fail to read on the claims.
The requirement is still deemed proper and is therefore made FINAL.
Claims 13 and 15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
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 1-12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a composition which reads on naturally occurring human breast milk without significantly more.
MPEP § 2106 sets forth the Subject Matter Eligibility Test to determine if a claim is directed to patent eligible subject matter. The following analysis is presented within the framework enumerated in MPEP § 2106.
Step 1 Is the 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.
Step 2A, Prong One Is the claim directed to a judicial exception? In this case, Claims 1-8 and 12 read on human breast milk as evidenced by Austin et al. “Temporal change of the content of 10 oligosaccharides in the milk of Chinese urban mothers”, Nutrients, 2016, 8, 346. As shown below, the human breast milk for the first lactation stage reported in Table 4 of Austin reads on present claims 1-8.
Claims
Claims
Austin et al.
2'FL
>375 mg/100g
375-1125 mg/100g
5.6-490 mg/100g
3FL
≤180 mg/100g
37-180 mg/100g
4.7-280 mg/100g
3'SL
≤75 mg/100g
7-75 mg/100g
6-23 mg/100g
6'SL
≤225 mg/100g
37-225 mg/100 g
3.3-69 mg/100g
2'FL:3FL
> 2.5:1
2'FL:3'SL
>11.2:1
2'FL:6SL
>1.8:1
Such breast milk would have contents of lipid, carbohydrate and protein as recited in claim 12. The limitations of claims 9-11 only require the presence of additional naturally occurring fructooligosaccharides and galactooligosaccharides. Therefore, 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.”
Markedly different characteristics analysis
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 modification of the ingredients within the claimed composition. The fact pattern in this application is similar to that found in Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 131 (1948) which stated “Each species has the same effect it always had. The bacteria perform in their natural way. Their use in combination does not improve in any way their natural functioning. They serve the ends nature originally provided and act quite independently of any effort of the patentee”. In the instant application each naturally occurring claim element has the same effect it always had. The claimed naturally occurring products perform in their natural way. Their use in combination does not improve in any way their natural functioning. They serve the ends nature originally provided and act quite independently of any effort of the patentee. As such, the characteristics of the claimed invention are not markedly different from their naturally occurring counterparts.
Therefore, the claims are drawn to naturally occurring human breast milk and mixtures thereof with naturally occurring products. Thus, the answer to Step 2A, Prong One, is Yes.
Step 2A, Prong Two: Does 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, only the composition is claimed. There is no practical application claimed. Thus, the answer to Step 2A, Prong Two, is No.
Step 2B: Do the 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, there are no additional elements, therefore the answer for Step 2B is no. As such, Claims 1-12 are not directed to patent eligible subject matter.
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.
Claims 5 and 7-11 are 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.
Claims 5 and 7-11 each recite the exemplary claim language term “preferably”. The use of this term leads to confusion over the intended scope of the claim because it is not clear if the claim is limited to the narrower, exemplary embodiment recited. For the purpose of examination the broadest version of the limitations claimed will be interpreted to read on the claims. Appropriate correction is required.
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.
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 1-8 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Austin et al. “Temporal change of the content of 10 oligosaccharides in the milk of Chinese urban mothers”, Nutrients, 2016, 8, 346.
Regarding claims 1-8, Austin teaches the oligosaccharide content of human milk in the first lactation stage of 5-11 days in Table 4. As shown below, the content of the oligosaccharides taught by Austin overlap or encompass the proportions and ratios recited in claims 1-8.
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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)
While the compositions reported in Table 4 of Austin are not described as “infant formula”, such compositions are materially indistinguishable from the scope of claims 1-8. As such, Austin renders obvious the composition of claims 1-8.
Regarding claim 12, human milk comprises lipid, protein and carbohydrate in proportions as recited in claim 12.
Claims 1-12 are rejected under 35 U.S.C. 103 as being unpatentable over Scholtens et al. “Stool characteristics of infants receiving short-chain galactooligosaccharides and long-chain fructo-oligosaccharides: A review”, World J. of Gastroenterology, 2014 October 7, 20(37):13446-13452 and Austin et al. “Temporal change of the content of 10 oligosaccharides in the milk of Chinese urban mothers”, Nutrients, 2016, 8, 346.
Regarding claims 1-11, Scholtens teaches an infant formula comprising galactooligosaccharides having a degree of polymerization of 3-8 and fructooligosaccharides having a degree of polymerization of >23. (pg. 13447)
Scholtens is silent regarding the human milk oligosaccharide contents recited in claims 1-8.
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Austin teaches the oligosaccharide content of human milk in the first lactation stage of 5-11 days in Table 4. As shown below, the content of the oligosaccharides taught by Austin overlap or encompass the proportions and ratios recited in claims 1-8.
Scholtens and Austin are both directed to nutritional compositions for infants. It would have been obvious to one of ordinary skill in the art at the time the application was filed to have included human milk oligosaccharides such as those taught by Austin the proportions taught by Austin the infant formula of Scholtens in order to best mimic human milk. This obvious modification of Scholtens would have produced an infant formula as recited in claims 1-11.
Regarding claim 12, Scholtens is silent regarding the lipid, carbohydrate and protein content of the formula disclosed. However, it would have been obvious to one of ordinary skill in the art at the time the application was filed to have optimized these contents depending on the caloric needs of the infant being fed. As such, the limitations of claim 12 are merely an obvious variant of the prior art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michele L Jacobson whose telephone number is (571)272-8905. The examiner can normally be reached Monday through Friday from 10-6.
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, Emily Le can be reached at (571) 272-0903. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Michele L Jacobson/Primary Examiner, Art Unit 1793