DETAILED ACTION
Background
The amendment dated April 30, 2026 (amendment) amending claim 1 has been entered. Claims 1, 5, 8-15 and 17 as filed with the amendment have been examined. Claims 2-4, 6-7 and 16 have been canceled. In view of the amendment, all outstanding claim objections have been withdrawn.
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 § 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.
Claims 1, 5, 8-15 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2018/178302 A1 to Vereijken et al. (Vereijken) in view of US2010/0092610 A1 to Haschke et al. (Haschke).
Regarding instant claims 1, 9 and 15, Vereijken at Example 1 discloses at page 14, lines 38-39 a method of administering to healthy term infants starting at < 35 days age (“for non-therapeutic improvement” to a “term born infant” in claim 9) an infant formula as a nutritional composition formulated (at page 15, lines 8-13) from cow's milk comprising 1.3 g protein, 7.3 g digestible carbohydrates, 3.4 g fat (“lipid”) and 0.8 g oligosaccharides (“carbohydrates”). At page 15, lines 13-15, Vereijken discloses an infant formula product as a powder reconstituted with water to make a ready to drink formula (claim 15). Further, at page 4, lines 5-12 Vereijken discloses infant subjects who are in an obesogenic environment that promotes weight gain.
The Office considers the claimed body mass index (BMI) or a gain in BMI as equivalent to body weight or weight gain as disclosed in Vereijken or in any other art reference.
Further and regarding instant claim 5, at Example 1 at page 15, lines 17-25, Vereijken discloses trial using a Diet 1 nutritional composition as an infant formula comprising a fat component of about 51 wt.% vegetable fat as a blend of low erucic acid rape seed oil, coconut oil, high oleic sunflower oil, sunflower oil and containing about 44 wt.% bovine anhydrous milk fat, and about 3.6 wt.% cow’s milk fat derived from milk fat globule membranes and having about 1.5 wt.% of a milk phospholipid, based on the total weight of lipid. The weight ratio of linoleic acid (14 wt%, claim 5) to alpha-linolenic acid (2.6 wt% in claim 5) in diet 1 of Vereijken is 5.4:1. Further, the disclosed Diet 1 lipid globules that have a) a mode diameter, based on volume of about 5.6 μm and that have phospholipids present in a coating on the lipid globules. In addition, at page 15, lines 2-6, Vereijken discloses that the trial was begun when the infants averaged 9 days and the formula was taken until the infants were 17 weeks of age (“wherein the nutritional composition is used at least during the first 3 months of life of the infant”).
Further and regarding instant claim 13, at page 15, lines 37-38, Vereijken discloses in Diet 1 that the lipid comprises about 36 wt% palmitic acid esterified to the sn-2 position of a triglyceride based on the total weight of palmitic acid (claim 13); and Vereijken discloses comparing its nutritional composition to the same nutritional composition in a Diet 2 having only about 12 wt% palmitic acid esterified to the sn-2 position of a triglyceride based on the total weight of palmitic acid.
Still further and regarding instant claim 8, Vereijken does not disclose an example of a method comprising administering a nutritional composition to an infant that is born to a mother that is overweight or obese at the time of conception of the infant or for the purpose of improving the postnatal growth trajectory or body development of the infant as in claim 1; and, further, does not refer to its method as a method for reducing the increase of body mass index (BMI) as the infant ages in the first 4 months of life compared to an infant that is born to a mother that is overweight or obese at the time of conception of the infant that is fed a nutritional composition selected from a control infant formula or follow on formula for comparison which comprises carbohydrates, protein and lipid, and at least 10 wt% palmitic acid based on the total weight of lipid, yet with less than 15 wt% palmitic acid residues esterified to the sn-2 position of triglyceride, not comprising phospholipids and having lipid globules with a particle volume mode diameter of about 0.5 µm. Still further, Vereijken does not disclose a growth trajectory or body development as the trajectory or development, wherein the increase of body mass index (BMI) is the increase of BMI in the first 12 months of life of the infant as in claim 8. However, the ordinary skilled artisan in Vereijken would have desired to test its nutritional composition by monitoring weight gain via a trajectory or development of BMI in infant subjects in the first 12 months of life precisely because Vereijken discloses treating infants that are in an obesogenic environment (at page 4, lines 5-12) that puts infants at risk of weight gain and identifies that very weight gain as a risk factor, thereby positing a lack of weight gain as a measure of success.
The Office interprets the recited control infant formula or follow on formula as including any composition that comprises any amount of comprises carbohydrates, protein and lipid, and comprising at least 10 wt% palmitic acid based on the total weight of lipid, yet with less than 15 wt% palmitic acid residues esterified to the sn-2 position of triglyceride, not comprising phospholipids and having lipid globules with a particle volume mode diameter of about 0.5 µm.
Haschke at [0006] discloses a nutritional composition comprising protein, carbohydrate and lipid and designed for and administered to infants at risk of developing obesity. At [0035] Haschke discloses administering the nutritional composition during the first 12 months of life. At [0004] the subject at risk infants are born to overweight or obese mothers. Further, Haschke at [0009] discloses nutritional compositions comprising linoleic acid and alpha-linolenic acid in a weight ratio of less than 7:1. And at [0015], Haschke defines an infant as a child under the age of 12 months and “obese mother” as a woman with a BMI of greater than 30 prior to the establishment of pregnancy.
The Office considers the recited method for reducing the increase of BMI of an infant to include the method disclosed in Haschke at [0005] of reducing an infant’s risk of developing obesity. Further, the Office considers the claimed testing to monitor BMI as a result of the claimed administering to include any disclosed weight gain monitoring as in Haschke.
Before the effective filing date of the present invention, the ordinary skilled artisan would have found it obvious in view of Haschke for Vereijken to administer its nutritional composition to infants in the first 12 months of life as in Haschke at [0035] and born to a mother that is overweight or obese at the time of conception of the infant to improve the postnatal growth trajectory or body development in an infant. Both references disclose infant formulas for improving postnatal body development in infants at risk of becoming obese. The ordinary skilled artisan working with Vereijken would have desired to feed its nutritional composition to infants born to a mother that is overweight or obese at the time of conception of the infant because that is how Haschke at [0015] defines an infant subject as having an obese mother.
The Office considers the method of administering the nutritional composition of Example 1 of Vereijken to an infant exposed to an obesogenic environment as in Haschke to be substantially the same as the claimed administering a nutritional composition to an infant born to a mother that is overweight or obese at the time of conception of the infant. Accordingly, absent a clear showing as to how the result obtained in the method in Vereijken as modified by Haschke differs from the result of the method as claimed, the Office considers the effect of administering the infant formula in Diet 1 of Example 1 of Vereijken to infants in comparison to the comparative Diet 2 in Vereijken having less than 15 wt% of palmitic acid esterified in the sn-2 position of palmitic acid in triglycerides as being that effect of producing an increase of body mass index (BMI) as the infant ages [that] is at least 3 fold lower in the first 4 months of life compared to an infant born to a mother that is overweight or obese at the time of conception of the infant and fed with a nutritional composition, selected from an infant formula or follow on formula, and comprising the same amount of the same carbohydrates, protein and lipid, and at least 10 wt.% palmitic acid based on total lipid, yet with less than 15% of the palmitic acid residues being in the sn-2 position of triglycerides, not comprising phospholipids and having lipid globules with a particle volume mode diameter of about 0.5 µm. See MPEP 2112.01.I.
Regarding instant claim 10, in Diet 1 Vereijken does not disclose a sphingomyelin content in the cow’s milk fat contained in that formula. However, at page 7, lines 16 and 21-23 Vereijken discloses that its formula preferably comprises from 15 to 35 wt% of sphingomyelin, based on the total weight of phospholipid. The ordinary skilled artisan would have found it obvious in view of Vereijken to administer to an infant a formula having the claimed at least 15 wt% sphingomyelin, based on the weight of total phospholipids because Vereijken discloses that a desirable infant formula comprises the claimed amount of sphingomyelin.
Regarding instant claims 11-12, 14 and 17, Vereijken discloses trial using a Diet 1 nutritional composition as an infant formula comprising a fat component of about 51 wt.% vegetable fat (“triglycerides of vegetable origin” in claim 14) as a blend of low erucic acid rape seed oil, coconut oil, high oleic sunflower oil, sunflower oil and containing about 44 wt.% bovine anhydrous milk fat, and about 3.6 wt.% cow’s milk fat derived from milk fat globule membranes (claim 11, as cow’s milk MFGM in buttermilk in claim 17) and having about 1.5 wt.% of a milk phospholipid, based on the total weight of lipid (claim 12).
Response to Arguments
In view of the amendment dated April 30, 2026, the following rejections have been withdrawn as moot:
The rejections of claims 1, 5, 8-15 and 17 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite in regard to the term “an infant formula or follow on formula” in claim 1, at lines 22-23.
Regarding the positions taken in the remarks accompanying the amendment dated April 30, 2026 (Reply), the positions have been fully considered but they are not found persuasive for the following reasons:
Regarding the position taken in Reply that the claimed control infant formula or follow on formula is not indefinite, the Office has withdrawn the indefiniteness rejection because the claim sets forth this formula as a control or comparison.
The Office interprets the recited control nutritional composition as being any composition that meets the claimed control composition. The term “control” is not defined in the instant specification. For clarity, the recited “control” nutritional composition does not mean “the same composition as the recited inventive composition but lacking the recited inventive improvements in the inventive nutritional composition”.
Regarding the position taken in the Reply alleging that the comparison set forth in the claims demonstrates unexpected results, respectfully this is not found to be the case! Both the recited inventive nutritional composition and the recited control infant formula or follow on formula includes any composition comprising any amount of any kind of carbohydrates, protein and lipid. Accordingly, the control is very broad; and no meaningful comparison to the claimed inventive composition can be drawn to the recited control because the claims allow for variation in any of the amount and kind of carbohydrates, protein and lipid. For example, the claims include a control nutritional composition having far more carbohydrates and far less fat or protein than the inventive nutritional composition. In such a case, no meaningful comparison between the recited inventive nutritional composition and the recited control can be made.
Regarding the position taken in the Reply that Vereijken does not disclose a BMI or administering a nutritional composition to an infant born to a mother who is overweight or obese at the time of conception, respectfully Vereijken is not relied on for either of these things. Haschke at [0003] reasonably discloses BMI as a measure of healthy body composition and Haschke at [0004] discloses that infants at risk of being obese are born to overweight or obese mothers. From this, Vereijken as modified by Haschke reasonably suggests treating an infant born to a mother who is overweight or obese at the time of conception because such an infant is in an obesogenic environment.
Regarding the position taken in the Reply at page 2 of 5 of comments that Vereijken is not concerned with reducing weight gain but rather with weight loss which is dangerous to infants, respectfully the position fails to properly read Vereijken as a whole. W.L. Gore & Assoc., Inc. v. Garlock, Inc., 721 F.2d 1540, 220 USPQ 303 (Fed. Cir. 1983), cert. denied, 469 U.S. 851 (1984). Vereijken at the Abstract clearly discloses treating infants. It is not reasonable then to read Vereijken as disclosing a method of inducing weight loss. Rather, the ordinary skilled artisan reading Vereijken would readily observe that the amount of weight gain or its development or trajectory is the relevant problem.
Regarding the position taken in the Reply citing the trial of Abrahamse-Berkevelde and alleging that it is the same clinical trial as claimed, respectfully even if the trial of Abrahamse-Berkevelde was made of record (which it has not been), the alleged comparison is just like that in the instant specification and fails to address the closest art of Vereijken which is the same composition as claimed. The nutritional composition in Diet 1 of Example 1 of Vereijken as the closest prior art must be a part of any comparison purporting to show unexpected results. The Office would consider a proper comparison as one that feeds the same composition to a non-specific target group of infants in an obesogenic environment versus administering it to healthy term infants born to mothers who are overweight or obese at the time of conception. Otherwise, the alleged comparison is simply ignoring the closest art of Vereijken.
Regarding the position taken in the Reply that Vereijken does not disclose the claimed effect of an at least 3 fold lower increase in BMI as the infant ages (and timing) in the first 4 months of life of the infant, respectfully this position is repeated from an earlier Reply and remains unpersuasive. As a rule, an alleged effect even if in the claims constitutes only alleges results; and, it is not a proper comparison, much less one addressing the closest art of Example 1, Diet 1 of Vereijken. Just as in the attempt to try and plug results into a claim without providing a proper comparison on the record, the position taken does not amount to evidence but is mere argument. Arguments of counsel cannot take the place of evidence on the record. See MPEP 716.01(c).II. Further, a showing of unexpected results must be based on evidence, not argument or speculation. In re Mayne, 104 F.3d 1339, 1343-44, 41 USPQ2d 1451, 1455-56 (Fed. Cir. 1997). See MPEP 2145.
Regarding the position taken in the Reply that a structural difference exists between the art and the claims as the target group differs between them, respectfully Vereijken is not cited as anticipating and is combined with Haschke for this reason. All of the statutory limitations of the instant claims are disclosed in Vereijken at Example 1 and at page 4, lines 5-12, except for a target group of infants which is identified by Haschke at [0004]. Nevertheless, Applicant has shown no unexpected results in comparison to Vereijken and will not overcome the rejection merely by continuing to allege that its result is superior until it has compared Vereijken Diet 1, Example 1 to the claimed invention on the record in a meaningful manner.
Regarding the position taken in Reply that Haschke does not disclose the claimed composition or method, respectfully one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In the instant case, Haschke is concerned with administering nutritional compositions to infants to address the same infant development problem as in Vereijken. Moreover, Haschke at [0004] is used in the manner of a dictionary reference that properly defines the obesogenic environment already disclosed in Vereijken as including infant subjects born to mothers who are overweight or obese, including at the time of conception and can be considered as an evidentiary disclosure
Regarding the position taken in the Reply that any art does not disclose the claimed result, respectfully the Office has no duty to find alleged unexpected results in the art. Rather, the Office only needs to find a reasonable basis for finding that the cited art would deliver those results.
Conclusion
THIS ACTION IS MADE FINAL. 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 ANDREW E MERRIAM whose telephone number is (571)272-0082. The examiner can normally be reached M-H 8:00A-5:30P and alternate Fridays 8:30A-5P.
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/ANDREW E MERRIAM/Examiner, Art Unit 1791
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