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 .
Application Status
Amended claim 1-6, 8-11, 15-23 and new claim 24 are under examination.
Claim 7 and 12-14 are cancelled.
Claim 1-6, 8-11 and 15-24 are rejected.
Withdrawn Rejection
The 35 U.S.C. 102(a)(2) rejection over claim(s) 10, 11 and 12 as being anticipated by McGrath et al. (US 11,547,744 B2) have been withdrawn in light of Applicant’s amendments submitted on 12/18/2025.
The 35 U.S.C. 103 rejection over claim(s) 1-8 and 15-23 as being unpatentable over McGrath et al. (US 11,547,744 B2) in view of Chow et al. (US 11,160,817 B2) have been withdrawn in light of Applicant’s amendments to recite new limitations submitted on 12/18/2025.
Claim Objections
Claim 10 is objected to because of the following informalities: claim 10, line 1 recites “…an infant formula of claim 1…” should be “…the infant formula of claim 1”. Appropriate correction is required.
Claim Rejections - 35 USC § 103
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.
Claim(s) 8, 9, 19, 20, 21 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over McGrath et al. (US 11,547,744 B2) in view of Chow et al. (US 11,160,817 B2) and Davis et al. (US 10,639,319 B2).
Regarding claim 8, 19, and 20, McGrath discloses a nutritional formula (infant formula) to provide nutrition to an infant (‘744, Abstract, col. 1, ln. 49-52, col. 3, ln. 27-35). The nutritional formula comprising human milk oligosaccharides (‘744, col. 28, ln. 15-16; col. 30, ln. 11-27) including 2’-fucosyllactose (2’-O-fucosyllactose) (‘744, col 30, ln. 23-24); microencapsulated docosahexaenoic acid (‘744, col. 25, ln. 4-37), wherein the docosahexaenoic acid (‘744, col. 25, ln. 4-33) from crypthecodinium cohnii oil (microalgae) (‘744, col. 25, ln. 25-33); maltodextrin (‘744, col. 23, ln. 43-44; col. 38, ln. 24), lutein (‘744, col. 24, ln. 50-53). McGrath discloses the nutritional formula is in powder form (‘744, col. 38, ln. 27-29) with a moisture level (water content) of approximately 2% or less (‘744, col. 39, ln. 20-24), which is in range with the cited range.
McGrath discloses an amount of the human milk oligosaccharides (‘744, col. 46, claim 14). McGrath does not explicitly disclose the cited amount of the human milk oligosaccharides, including the 2’-fucosyllactose (2’-O-fucosyllactose) (‘744, col 30, ln. 23-24). However, Chow et al. (Chow) discloses nutritional composition for infant (‘817, col. 5, ln. 19-25) comprising human milk oligosaccharides in an amount of about 0.0005% to about 5% by weight of powder (‘817, col. 6, ln. 8-10), which overlaps the cited range. 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). McGrath and Chow are of the same field of endeavor of nutritional formula comprising human milk oligosaccharide. It would have been obvious to one of ordinary skill in the art to be motivated to use Chow’s amounts of the human milk oligosaccharides including 2’-fucosyllactose (2’-O-fucosyllactose) in McGrath’s nutritional formula to provide a desired health benefit as taught by Chow (‘817, col. 5, ln. 1-25).
McGrath does not explicitly disclose the maltodextrin (‘744, col. 23, ln. 43-44; col. 38, ln. 24) as corn maltodextrin. However, Davis et al. (Davis) disclose a nutritional composition comprising human milk oligosaccharides for infants (‘319, Abstract; col. 7, ln. 18-68; col. 8, ln. 1-8) and corn maltodextrin (‘319, col. 18, Example 1-5, table). McGrath and Davis are of the same field of endeavor of nutritional composition comprising human milk oligosaccharides for infants. It would have been obvious to one of ordinary skill in the art to be motivated to employ Davis’s corn maltodextrin in modified McGrath’s nutritional formula (infant formula) since Davis teaches known and successful corn maltodextrin as a carbohydrate source in nutritional composition comprising human milk oligosaccharides for infants.
With respect to the recitation of “less than 5 weight % of rice maltodextrin” wherein the limitation encompass a zero amount of arsenic; modified McGrath meets the range of a zero amount of rice maltodextrin in the nutritional formula since McGrath does not disclose rice maltodextrin in the nutritional formula,
With respect to the recitation of “wherein the infant formula comprises less than 95 parts per billion of arsenic”, wherein the limitation encompass a zero amount of arsenic; modified McGrath meets the range of a zero amount of arsenic in the nutritional formula since McGrath does not disclose arsenic in the nutritional formula.
Regarding claim 9, modified McGrath discloses the claimed invention as recited in claim 8, wherein modified McGrath discloses the nutritional formula is in the powder form (‘744, col. 38, ln. 27-29) to provide nutrition to an infant (‘744, Abstract, col. 1, ln. 49-52, col. 3, ln. 27-35). With respect to the recitation of “wherein the infant formula comprises less than 90 parts per billion of arsenic”, wherein the limitation encompass a zero amount of arsenic; modified McGrath meets the range of a zero amount of arsenic in the nutritional formula since McGrath does not disclose arsenic in the nutritional formula.
Regarding claim 21 and 22, modified McGrath discloses vitamins including vitamin D (‘744, col. 11, ln 36-49).
Claim(s) 1-6, 10-11, 15-18, 23 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Jennewin (WO 2019/11801 A1) in view of McGrath et al. (US 11,547,744 B2) and Davis et al. (US 10,639,319 B2).
Regarding claim 1, 2, 3, 4, 6, 17, and 23, Jennewin discloses an infant formula (‘801, pg. 14-16) comprising spray-dried (crystallized), human milk oligoscaccharides including 3-fucosyllactose (‘801, pg. 4, ln. 18-25; pg. 5, ln. 17-29) (fermented product). Jennewin discloses the human milk oligoscaccharides in an amount of 0.57 to 0.65 grams/100 ml of the infant formula (‘801, pg. 15), which corresponds to a range of 0.57% w/v to 0.65% w/v; and within the cited range. Jennewin discloses the spray-dried (crystallized), human milk oligoscaccharides (fermented product) is less than 5% wt of water (‘801, pg. 5, ln. 7), which is the same range as claimed.
Jennewin discloses the infant formula comprising polyunsaturated fatty acids (‘801, pg. 15). Jennewin does not explicitly disclose the polyunsaturated fatty acids is fungi oil comprising docosahexaenoic acid. However, McGrath et al. (McGrath) discloses a nutritional formula (infant formula) to provide nutrition to an infant (‘744, Abstract, col. 1, ln. 49-52, col. 3, ln. 27-35). The nutritional formula comprising human milk oligosaccharides (‘744, col. 28, ln. 15-16; col. 30, ln. 11-27), docosahexaenoic acid (‘744, col. 25, ln. 4-33) wherein the docosahexaenoic acid (‘744, col. 25, ln. 4-33) from crypthecodinium cohnii oil (microalgae) (‘744, col. 25, ln. 25-33). With respect to claim 6, the crypthecodinium cohnii oil (microalgae) (‘744, col. 25, ln. 25-33) is coacervate. Jennewin and McGrath are of the same field of endeavor of infant formula with human milk oligoscaccharides and polyunsaturated fatty acids. It would have been obvious to one of ordinary skill in the art to be motivated to use McGrath’s docosahexaenoic acid (‘744, col. 25, ln. 4-33) from crypthecodinium cohnii oil (microalgae) (‘744, col. 25, ln. 25-33) in Jennewin’s infant formula as a matter of preference of for polyunsaturated fatty acids. With respect to claim 17 and 23, McGrath teaches microencapsulated docosahexaenoic acid (‘744, col. 25, ln. 4-37), wherein the docosahexaenoic acid (‘744, col. 25, ln. 4-33) from crypthecodinium cohnii oil (microalgae) (‘744, col. 25, ln. 25-33)
Jennewin does discloses carbohydrates in the infant formula (‘801, pg. 15). Jennewin is silent on the carbohydrates is corn maltodextrin. However, Davis et al. (Davis) disclose a nutritional composition comprising human milk oligosaccharides for infants (‘319, Abstract; col. 7, ln. 18-68; col. 8, ln. 1-8) and corn maltodextrin (‘319, col. 18, Example 1-5, table). Jennewin and Davis are of the same field of endeavor of nutritional composition comprising human milk oligosaccharides for infants. It would have been obvious to one of ordinary skill in the art to be motivated to employ Davis’s corn maltodextrin in modified Jennewin’s infant formula (since Davis teaches known and successful corn maltodextrin as a carbohydrate source in nutritional composition comprising human milk oligosaccharides for infants.
With respect to the recitation of “wherein the infant formula comprises less than 95 parts per billion of arsenic”, wherein the limitation encompass a zero amount of arsenic; modified Jennewin meets the range of a zero amount of arsenic in the nutritional formula since Jennewin does not disclose arsenic in the nutritional formula.
With respect to the recitation of “wherein the fermentation product has been subjected to a final purification step and wherein the final purification step is… not activated charcoal treatment” in claim 1; and “wherein purification is not activated charcoal treatment” in claim 3, are product by process recitation; MPEP 2113
I. PRODUCT-BY-PROCESS CLAIMS ARE NOT LIMITED TO THE MANIPULATIONS OF THE RECITED STEPS, ONLY THE STRUCTURE IMPLIED BY THE STEPS
"[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
Modified Jennewin’s spray-dried (crystallized), human milk oligoscaccharides including 3-fucosyllactose (‘801, pg. 4, ln. 18-25; pg. 5, ln. 17-29) (fermented product) is purified (‘801, pg. 5, lines 11-16; pg. 8, ln. 16-17)).
Regarding claim 5, modified Jennewin discloses vitamin including vitamin A (‘801, pg. 13, ln. 17-18). Jennewin is silent on lutein. However, McGrath discloses the nutritional formula (infant formula) comprising lutein (‘744, col. 24, ln. 50-53). Jennewin and McGrath are of the same field of endeavor of infant formula with human milk oligoscaccharides. It would have been obvious to one of ordinary skill in the art to be motivated to use McGrath’s lutein (‘744, col. 24, ln. 50-53) in Jennewin’s infant formula for known health benefits.
Regarding claim 10, the recitation of the amended claim is a product by process limitation; MPEP 2113
I. PRODUCT-BY-PROCESS CLAIMS ARE NOT LIMITED TO THE MANIPULATIONS OF THE RECITED STEPS, ONLY THE STRUCTURE IMPLIED BY THE STEPS
"[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
Modified Jennewin’s spray-dried (crystallized), human milk oligoscaccharides including 3-fucosyllactose (‘801, pg. 4, ln. 18-25; pg. 5, ln. 17-29) (fermented product) is purified (‘801, pg. 5, lines 11-16; pg. 8, ln. 16-17)) as discussed above and meets the claim.
Regarding claim 11 and 16, modified Jennewin discloses the infant formula comprising 2’O-fucosyllactose (‘801, pg. 12, ln. 25-27).
Regarding claim 15, modified Jennewin discloses the infant formula with water to provide final concentration as baby food (‘801, pg. 16, Table 3).
Regarding claim 23 and 24, with respect to the recitation of “less than 5 weight % of rice maltodextrin” wherein the limitation encompass a zero amount of arsenic; modified Jennewin meets the range of a zero amount of rice maltodextrin in the infant formula since Jennewin does not disclose rice maltodextrin in the infant formula.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-6, 8-12 and 15-23 have been considered but are moot because the new ground of rejection does not rely on the combined reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
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/HONG T YOO/Primary Examiner, Art Unit 1792