DETAILED ACTION
Background
The amendment dated November 28, 2025 (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 In view of the amendment, all outstanding claim objections have been withdrawn.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 Objections
Claim 1 is objected to because of the following informalities:
In claim 1, at the 4th to last line before “comprising carbohydrates” delete [[, and]]; and,
at the next to last line after “comprising phospholipids and” insert -- not--.
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 1, 5, 8-15 and 17 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.
In claim 1, at lines 22-23 the term “an infant formula or follow on formula” is indefinite because the scope of the comparative infant formula or follow on formula is almost infinitely variable, is not clear and cannot be ascertained. In fact, the only possible meaningful comparative infant formula or follow on formula is the exact same formula as claimed but comprising 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, and not comprising phospholipids and having lipid globules with a particle volume mode diameter of about 0.5 µm.
Claims 5, 8-15 and 17 are rejected as dependent on a rejected base claim.
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.
Regarding instant claims 5, 11-12, 14 and 17 and further regarding instant claim 1, 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 (“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). 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”).
Regarding instant claim 13 and still further regarding instant claim 1, 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.
Vereijken does not disclose 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; and, further, does not refer to its method as a method for reducing the increase of BMI as a method for postnatal growth trajectory or body development of the infant in the first 12 months of life of the infant, or provide an intended result of monitoring the growth trajectory or body development via the trajectory or development of body mass index (BMI), as in claim 1. Further, Vereijken does not disclose a comparison in Example 1 to determine the effect of the administering the nutritional composition on the increase in body mass index (BMI) in an infant to that given by a nutritional composition with less than 15 wt% palmitic acid esterified to the sn-2 position of a triglyceride based on the total weight of palmitic acid. Still further, Vereijken does not disclose a growth trajectory or body development as the trajectory or development of body mass index (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.
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 Haschke disclosure 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.
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 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, [and] 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.
Response to Arguments
Regarding the positions taken in the remarks accompanying the amendment dated November 28, 2025 (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 ordinary skilled artisan would never arrive at a method of administering the recited nutritional composition to infants born to mothers who are overweight or obese at the time of conception in combining Vereijken and Haschke, this position is respectfully not found persuasive. Vereijken at page 4, lines 5-12 discloses treating infants in an obesogenic environment, defined as an environment that promotes, induces, helps, or contributes to obesity. Haschke at [0004] discloses that infants at risk of being obese are born to overweight or obese mothers. Clearly, then Vereijken as modified by Haschke 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 that critical aspects of claim 1 not shown in the art include administration during the first 3 months of the life of the infant, respectfully Vereijken clearly discloses this in Example 1 at the paragraph bridging pages 14 and 15.
Regarding the position taken in the Reply that it is not relevant that Vereijken discloses the same composition as claimed and uses the same control composition, respectfully this represents an admission that Vereijken discloses the claimed composition and is highly relevant as art. In addition, the nutritional composition in Diet 1 of Vereijken must be a part of any comparison purporting to show unexpected results. And a proper comparison must address the method of Example 1 of Vereijken as the closest prior art.
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 the alleged effect constitutes alleged results and are alleged without there being a proper comparison on the record addressing the closest art of Example 1, Diet 1 of Vereijken.
Regarding the position taken in the Reply that Vereijken “refers to non-conduciveness of weight loss” and is not concerned with reducing weight gain, respectfully when properly reading the art as a whole this position is taken out of context and is unhelpful to Applicants. Indeed, it is the obesogenic environment in Vereijken (page 4, lines 5-12) that is “not conducive to weight loss” and not the method of Vereijken. Rather, Vereijken clearly discloses obesity as a problem to be avoided, particularly in view of Haschke at [0004] where the obesity of the infant’s mother poses a risk of undesired weight gain, i.e. presents an obesogenic environment.
Regarding the position taken in the Reply at page 3 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. 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 Haschke 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.
Regarding the position taken in the Reply at page 5 that the rejection is based on inherency, respectfully this is not found correct because inherency refers to invariable properties and not alleged unexpected results! 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] as falling with the scope of the obesogenic environment defined in Vereijken. The alleged unexpected results are not an inherent property of the recited method and, aside from setting forth an intended use derive no additional meaning from having been put in the claims versus not being claimed. As such, an intended use feature is only given weight to the extent that it results in a structural difference between the claimed method and that of the art. See MPEP 2111.02.II. The only such difference is the target group of infants.
Where, as here a proper prima facie case has been made, the burden falls to Applicant to show unexpected results comparing the closest prior art. 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. And the showing in this case must address Example 1, diet 1 of Vereijken. However, the Reply makes no attempt to explain how the alleged comparisons fairly address the art of Vereijken or to provide the requisite valid comparison to show any unexpected result over the closest art of Vereijken.
Regarding the data presented in the instant specification, even if those data properly address the closest prior art of Vereijken, which they do not, those data in Tables 5 and 6 are found to be indeterminate because the reported P-values for the “Normal” data show those data to be insignificant. In addition, the standard error (SE) in Tables 5 and 6 when properly interpreted to give a range of the reported mean values is so large that the reported mean values in the Table for Normal and Overweight/Obese nearly overlap or give the same result as one another when factoring in the standard error. It would further be helpful in any such experiment to actually report BMI values or at least their averages, including standard error or standard deviation as appropriate, and not just BMI categories as in Tables 3 and 4.
Conclusion
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.
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, Nikki H Dees can be reached on (571) 270-3435. 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.
/ANDREW E MERRIAM/Examiner, Art Unit 1791