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 March 12, 2026 has been received and entered.
3. Claims 1-6 and 12-19 are currently pending.
Election/Restrictions
4. Applicant’s election without traverse of Group I, claims 1, 4, 6, and 16-19, and the combination of L-glutamine and L-asparagine for the species in the reply filed on March 12, 2026 is acknowledged.
5. Claims 2, 3, 5, and 12-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
6. Claims 1, 4, 6, and 16-19 are examined on the merits in regards to the elected species.
Specification
7. The disclosure is objected to because of the following informalities: on page 10, the heading “Brief Description of the Drawing” needs to be included before the drawing description.
Appropriate correction is required.
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 4 and 18 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.
8. Claim 4 is indefinite because there is a lack of antecedent basis for “the fortified infant nutrition” as recited in lines 1-2 of the claim. In addition, it appears that a term may be missing after “nutrition”.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 4 recites the broad recitation “the fortified infant nutrition”, and the claim also recites “in particular the fortified human milk” which is the narrower statement of the range/limitation. In addition, the claim recites the broad recitation of “in an amount of ate lest 8.5 mg/100ml”, and the claim also recites “in particular 8.5 to 100 mg/100ml” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
9. Claim 18 is indefinite because there is a lack of antecedent basis for “the fortified infant formulation” in the claim.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
10. Claims 4 and 18 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claims 4 and 18 do not further limit claim 1 because they state that the fortified composition can be an “infant nutrition” or an “infant formula.” Claim 1 requires that the composition be fortified human milk rather than formula or other type of nutritional composition. Thus, claims 4 and 18 do not properly further limit claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
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.
11. Claim(s) 1, 4, 6, and 16-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Garssen (US 2019/0076490) in view of “Can Your Children Get Allergy Hereditarily?” (Oklahoma Otolaryngology Associates, July 2019, accessed at https://www.okoa.org/articles/can-your-children-get-allergy-hereditarily) and Harzer (DD 297304 A5 – English translation).
Garssen teaches a method for fortifying human milk with free glutamine to feed to infants who are at risk for an allergy. The reference teaches that the glutamine is powdered (see paragraphs 19, 22, 26, 27, 37, 59 and 60). The reference does not specifically teach including free asparagine in the fortification composition or that the human milk is from a lactating woman who has an allergy or who has had an allergy.
However, the “Can Your Children Get Allergy Hereditarily?” article teaches that parents who suffer from allergies such as hay fever or eczema (atopic dermatitis) have a 31-91% and a 71-84% chance, respectively, the pass the allergies on to their children. Thus, an artisan of ordinary skill would reasonably expect that a lactating mother with allergies would have an infant who is at risk for developing an allergy. Given this reasonable expectation, the artisan of ordinary skill would be motivated to specifically fortify the milk from a mother with allergies with the glutamine as taught by Garssen because that infant would be at risk for developing allergies.
In addition, Harzer teaches fortifying human milk with both free glutamine and free asparagine to provide optimal nutrition for infants. The reference teaches that the amino acids are powdered (see pages 3 and 5 of the translation). Thus, an artisan would reasonably expect that asparagine could be added to the milk fortification composition taught by Garssen in order to achieve a more complete nutritional product as taught by Harzer. This reasonable expectation of success would have motivated the artisan to modify Garssen to include asparagine in the fortification composition. Thus, the combination of the prior art is considered to teach fortifying human milk from a lactating mother with allergies with asparagine and glutamine and feeding the infant with this fortified 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).” The references teach the use of each of the ingredients in a pharmaceutical composition. Varying the concentration of ingredients within a pharmaceutical composition is not considered to be inventive unless the concentration is demonstrated as critical. In this particular case, there is no evidence that the claimed concentration 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.
12. 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.
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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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