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 .
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 1-22 are rejected under 35 U.S.C. 101 the claimed invention is directed to a product of nature 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 1-22 are directed to mixtures of naturally occurring materials which mimic human breast milk. 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 (i.e. breast milk) 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 mixtures of 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. While the claims have been amended to recite a “breast milk mimicking” composition, this is not a practical application that breathes life into the claim beyond the compositional limitations. Indeed, the recitation that the composition mimics breast milk brings the claims into even closer alignment with naturally occurring breast milk. This limitation is not beyond the judicial exception and therefore 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.” While the claims have been amended to recite a “breast milk mimicking” composition, this does not amount to more than the judicial exception because it has no bearing on the composition recited. Indeed, the recitation that the composition mimics breast milk brings the claims into even closer alignment with naturally occurring breast milk. Therefore the answer for Step 2B is no.
As such, Claims 1-22 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.
Claims 1, 2, 4, 5, 10-17 and 19-22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Destaillats USPGPub 20160037818.
Regarding claims 1, 2, 15 and 17, Destaillats teaches an infant formula comprising saturated and unsaturated fatty acids and 18.76 wt% palmitic acid. (Table 1) The composition of Destaillats does not comprise palm oil and “mimics” human breast milk. [0037] of applicant’s specification states that “breast milk mimicking” compositions are within +/- 25% of the fatty acid profile of “optimized human breast milk” for “one or more components”. The composition of Destaillats comprises intermediate chain fatty acids (C12-C14) in a proportion of 10.83% which is within the range of intermediate chain fatty acids in Table A. Therefore, the composition of Destaillats satisfies this limitation of the claims.
Regarding claims 4 and 19, the composition of Destaillats comprises 11.48 wt% linoleic acid and 1.10 wt% alpha-linolenic acid which works out to a ratio of linoleic:linolenic of 10.43:1.
Regarding claims 5, 10-14 and 20-22, these claims recite product-by-process limitations regarding where the oils present in the composition are derived from. The recitation “derived from” in claims 5, 12-14 and 20 does not require the presence of the lipids recited, only that lipids present in the composition could be “derived from” such lipids. Since all of the lipids in Destaillats are materially indistinguishable from the same claimed lipids that are “derived from” whole milk, plant or recombinant sources, the composition of Destaillats is materially indistinguishable from the composition encompassed by claims 5, 10-14 and 20-22. (See MPEP 2113)
Regarding claim 16, the formula of Destaillats mimics human breast milk.
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.
Claims 3, 6-8 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Destaillats USPGPub 20160037818 as applied to claims 1 and 15 above.
Regarding claims 3 and 18, Destaillats teaches arachidonic and docosahexaenoic acid may be present in the composition disclosed in ratios of 1:2 to 10:1 which encompasses the range recites in claims 3 and 18.[0075] 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)
Regarding claims 6-8, Destaillats discloses cow milk powder (i.e. whole milk) maybe present in the composition. [0073] Whole milk powder has a fat content as recited in claim 8. The composition is recited to comprise 38-42 wt% milk fat. It would have been obvious to one of ordinary skill in the art at the time the application was filed to have optimized the amount of milk powder used to ensure an appropriate amount of milk fat in the composition of Destaillats. Therefore, claims 6-8 do not provide a patentable distinction over the prior art.
Response to Arguments
Applicant's arguments filed 8 January 2026 have been fully considered but they are not persuasive.
Applicant asserts on page 9 of the remarks that the instant claims “do not tie up any nature-based products”. This assertion is not persuasive since human breast milk literally reads on the claims. Applicant further asserts that the recitation that the claimed composition mimics breast milk requires a mixture that “resembles or approximates the composition, nutritional profile, or functional properties of human breast milk” without using human breast milk fatty acid extracts. The instantly pending claims are directed to a product, not a method of making a formula without using human breast milk fatty acid extracts. While applicant asserts on pages 9 and 10 of the remarks that none of the fatty acids alone mimic the properties of breast milk, this assertion contradicts applicant’s insistence that the claims must be considered as a whole. When considered as a whole, the claims read on breast milk and therefore applicant’s assertion that eligibility is self-evident is not found persuasive.
Applicant states on page 10 of the remarks that “The claimed compositions are therefore engineered to replicate something that does not naturally occur outside human breast milk itself”. This admission demonstrates the propriety of the instantly pending 101 rejection. Applicant has conceded that the claims are intended to encompass compositions the same as breast milk. Whether making such compositions requires “deliberate human intervention” as stated on page 11 of the remarks is immaterial to the fact that the scope of the instantly pending claims read on breast milk. As such, it is internally inconsistent for applicant to then assert “the claimed compositions have markedly different characteristics from any naturally occurring product” given that applicant stated that the claimed compositions are engineered to “replicate” human breast milk.
Applicant’s remarks on page 11 regarding palmitic acid are not persuasive as the absence of something that is not naturally occurring does not support applicant’s position that the claimed compositions are not products of nature.
Applicant’s remarks regarding the 35 U.S.C. 112(b) rejection of claims 7 and 9 on page 12 of the remarks are acknowledged and the rejections have been withdrawn.
Applicant asserts on page 14 of the remarks that the composition of Destaillats contains palm oil because it is derived by interesterification of palm oil. Once palm oil has been interesterified and the fatty acid moieties have been shuffled between the triacylglycerol molecules, it is no longer identifiable as palm oil, it is merely a mixture of triglycerides. Instead, it is a molecularly distinct structure having fatty acid residues that are rearranged from that present in palm oil. As such, applicant’s assertion is not found persuasive.
Applicant asserts on page 15 of the remarks that the composition of Destaillats fails to fall within +/- 25% of the fatty acid profile of “optimized human breast milk” shown in Table A of applicant’s specification. [0037] of applicant’s specification states that “breast milk mimicking” compositions are within +/- 25% of the fatty acid profile of “optimized human breast milk” for “one or more components”. The composition of Destaillats comprises intermediate chain fatty acids (C12-C14) in a proportion of 10.83% which is within the range of intermediate chain fatty acids in Table A. Therefore, the composition of Destaillats satisfies this limitation of the claims.
Applicant’s assertion on page 16 of the remarks that Destaillats fails to teach a composition with a fatty acid profile within +/- 25% of every component in Table A is not germane as by applicant’s own definition, only one component needs to fall within Table A.
It is unclear how applicant’s remarks on pages 16 and 17 regarding result effective variable are germane as the instant rejection of claims 3 and 18 does not rely on optimization. As such, these assertions are not found persuasive.
Conclusion
Applicant's amendment necessitated the new 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 nonprovisional extension fee (37 CFR 1.17(a)) 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.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Michele L Jacobson/Primary Examiner, Art Unit 1793