3DETAILED 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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/29/2025 has been entered.
Election/Restrictions
Applicant’s election of Group I, claims 1-28, 30-65, in the reply filed on 7/19/2024 remains acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Applicant’s election of the nutritional formula of claim 1; i.e., the combination of:
a) alpha-lactalbumin enriched whey protein concentrate;
b) lactoferrin;
c) oleic acid-palmitic acid-oleic acid triglyceride (OPO triglyceride), wherein palmitic acid is at the SN-2 position of the glycerol backbone of the OPO triglyceride;
d) lactose;
e) lutein;
f) docosahexanoic acid;
g) arachidonic acid;
h) galactooligosaccharides;
i) polydextrose; and
j) fructooligosaccharides; and
k) osteopontin,
in the reply filed on 7/19/2024 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 66-67 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/19/2024.
Claims 3-5, 8, 11, 34-35, 37, 55, 64, 75-81 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/19/2024.
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 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, 13-14, 16, 20, 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ao et al. (US 2016/0015068 A1; 2016 Jan 21; IDS reference), in view of Sorensen et al. (US 2014/0037818 A1; 2014; IDS reference); and Petta et al. (RU2575610C2; 2016 Feb; IDS reference), as evidenced by O’Connor (“Infant Formula”; Am Fam Physician; 2009;79(7):565-570; IDS reference).
Ao discloses a nutritional formula (a nutritional formula composition; abstract, [0164]) comprising:
whey protein concentrates [0095], [0097], Table 6; per a) of claim 1; regarding the amended at least 30% alpha-lactalbumin, target protein is lactoferrin or other milk proteins, such as lactalbumins, also may be isolated, [0122] (lactalbumin in an amount at least 30% of the milk/whey it is isolated from) (alpha lactalbumin is also named as a suitable emulsifier, added for stability of the final product, [0134]; i.e., rendering obvious enriched alpha lactalbumin, obtained from milk/whey);
lactoferrin, a probiotic [0012], [0117], [0127], Table 6; reading in b) of claim 1; the amount of Table 6 is 0.55 g per 100 g (about 0.055 per L of reconstituted, ready to use);
fat blend with structured lipids (Table 6); structured lipids comprise triglycerides having 10-70% of the palmitic acid (C16:0) residues in the triglycerides are esterified at the sn-2 position (claim 1); the most abundant saturated fatty acid in human breast milk is palmitic acid (C16:0), with high levels of C16:0 attached to the sn-2 position whereas the major unsaturated fatty acids, e.g., oleic acid (C18:1(n-9)) esterified at the sn-1 position [0004]; see Figure 1; structured lipids include triglycerides with palmitic acid in the sn-2 position… monounsaturated fatty acids, for example oleic acid, in the sn-1 and sn-3 positions [0074]; this suggests oleic acid-palmitic acid-oleic acid triglyceride, with palmitic acid at the sn-2 position, as required by c) of claim 1; amount taught is 24.7 g per 100 g; i.e., about 2.47 g per L, reading on claim 1 c);
lactose (Table 6); relevant to d) of claim 1; relevant to the claim amendment, amounts include 39.76-41.25 g per 100 g (i.e., about 4-4.1 grams per L, assuming a density of about 1 g/mL), reading on the amended range of claims 1 & 55 d)
lutein (inherent lutein, [0047]); reading on e) of claim 1 & 55;
docosapentaenoic (22:6 n-3), i.e., docosahexaenoic acid, aka DHA [0100]-[0103], Table 6; reading on f) of claim 1;
arachidonic acid, a prebiotic (ARA) [0012], Table 6; reading on g) of claim 1;
galacto-oligosaccharide, a prebiotic [0115], [0116], aka GOS; Table 6, reading on h) of claim 1; it is noted that the combination of 2 prebiotics is used in an amount of 5.1 g per 100 g, about 0.51 g/L, rendering obvious about half this amount, 0.0255 g/L of GOS as obvious
polydextrose or polydextrose powder, a prebiotic [0115], [0116]; aka PDX, Table 6, reading on i) of claim 1; it is noted that the combination of 2 prebiotics is used in an amount of 5.1 g per 100 g, about 0.51 g/L, rendering obvious about half this amount, 0.255 g/L of PDS as obvious and
fructooligosaccharides, indigestible oligosaccharide [0094]. Consideration of alternate Prebiotics amounts would have been considered to render obvious amounts, i.e., about 0.25 g/L is obvious for each prebiotic, based on the 2 Prebiotics amount in Table 6.
An obvious amount of galactooligosaccharides, polydextrose and fructooligosaccharides would have been the combination of three of the 2 prebiotics amounts, i.e., about 0.76 g/L, rendering obvious the wherein clause of claim 1, following j).
With respect to a) of claim 1 a), alpha-lactalbumin enriching portion of whey protein concentrate, lactalbumins are recognized milk proteins [0122]. (A combination of lactalbumin and whey protein concentrate in a mixed formulation would not be distinguishable from lactalbumin enriched whey protein concentrate.) See also alpha lactalbumin, taught to be an emulsifier that may be added for stability of the final product, [0134], rendering obvious use of at least 30% concentrated milk/whey protein concentrate.
In some embodiments the nutritional composition is an infant formula [0088], claim 14.
Regarding claim 1 d) [0093], which names lactose as an exemplary carbohydrate, indicates carbohydrate range from 5 g to 25 g/100 kcal. 39.76 g is present per 100 g (Table 4), construed as 39.76 weight % concentration of lactose in a ready to use formulation, which would have been an obvious target for a concentrate to be reconstituted; similar concentrations are taught in Tables 5-6, concentrations within the claimed range of claims 1 & 55, d).
Ao teaches, inter alia, a ready-to-use product [0142], rendering obvious the claimed form.
Ao does not teach osteopontin, k) component of claim 1; nor the concentration of alpha-lactalbumin enriching whey protein concentrate, as recited in a) of claim 1.
Regarding the amount of lactoferrin required by claim 14, Table 6 teaches 0.55 g per 100 g is taught, which corresponds to about 0.055 g per 1000 g (per L). Additionally, [0127] indicates lactoferrin is used in an amount from 10 mg/kcal to 250 mg/kcal. Presuming a reconstituted, ready-to-use formula is formulated to contain 20 kcal per ounce, modeled after breast milk (see O’Connor; “Infant Formula”; Am Fam Physician; 2009;79(7):565-570, p. 536, 3rd paragraph); corresponding to 676 kcal per L (33.814 fl. oz. per L), this range corresponds to 0.067 to 1.69 g per L, which overlaps with the claim 14 range, rendering the claimed range prima facie obvious (MPEP 2144.05 (I)).
Regarding claim 16, the amount of structured lipid ranges between 50 mg and 850 mg per 100 kcal of structured lipids, with 10-70% palmitic acid residues in sn-2 position [0055], corresponding to 0.338 g/L to 5.746 g/L (based on 676 kcal per L) of structured lipid. When this is reduced to 10-70%, the range corresponds to 0.034 g to 4.022 g/L of the obvious OPO triglyceride; i.e., the recited range lies within the prior art range, rendering the claimed range prima facie obvious (MPEP 2144.05 (I)).
Regarding claim 20, DHA amounts range from 5 mg to 75 mg/100 kcal [0101], corresponding to 0.0338 to 0.507 g/L, overlapping with the claim 20 range, rendering the claimed range prima facie obvious (MPEP 2144.05 (I)).
Regarding claim 22, the ratio of ARA:DHA in a particular embodiment has a ratio from 1:2 to 4.1 [0102]. Taken together with the amounts of DHA, this corresponds to 0.1352 to 2.028 g/L for the 4:1 embodiment. This range overlaps with the claimed range, rendering the claimed range prima facie obvious (MPEP 2144.05 (I)).
Regarding the polydextrose concentration range of amended claim 1, (i), the amount of polydextrose (PDX) + galactooligosaccharides (GOS) is taught as 5.1 g/100 g, i.e., about 0.51 g/L. for the combination in each of Tables 4, 5 & 6. The skilled artisan would have found each to be used in similar amounts, as illustrated by exemplary matching ranges of [0116]. Thus, about half of exemplary amounts for each are clearly prima facie obvious. Both are named as prebiotics (Tables 4, 5, 6). This is evidential that these components are functionally the same, rendering similar amounts prima facie obvious. Additionally, this approach would yield starting amounts, from which it would have been prima facie obvious to routinely optimize amounts to determine workable amounts, rendering the claimed range obvious. Additionally, fructooligosaccharides are also named at [0115] as being prebiotics; determining obvious amounts would also have been obvious from examining PDX + GOS amounts in these Tables 4, 5 & 6.
As pointed out in MPEP 2144.05 II, 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). Examiner notes there has been no evidence of criticality of the amount of amended i), or of the wherein clause sum.
Petta teaches milk whey protein based food product (abstract), containing a whey protein enriched with alpha-lactalbumin [15], [24]. The formulae are nutritive food products (claim 7).
Thus, Petta establishes that enriched whey protein with alpha-lactalbumin is suitable for nutritive formulations, it would have been obvious to add the alpha-lactalbumin to the components taught by Ao, outlined above, satisfying component a) of claim 1. Regarding the alpha-lactalbumin amount required by claim 13, considering amounts of other proteins taught by Ao (for instance, soy protein in Table 1 at 15 g/100g, about 1.5 g per L; or the alternative from lactalbumin taught to be lactoferrin, which is taught at 0.55 g per 100 g, i.e., about 0.055 gram per L), it would have been obvious to utilize similar amounts of alpha-lactalbumin to either of these amounts and to optimize the amount via routine optimization, giving workable amounts within the claimed amount range of claims 1a) & 13.
Sorensen teaches infant formula containing osteopontin (OPN) as a supplement for infant formulas (abstract). It has been found that human milk on an average contains about 25-300 mg/L, about 5-10 times as much OPN as bovine milk [0005]. OPN possesses a key function in the acquisition of Th-1-response; OPN is therefore believed to be an essential component in human milk for infant nutrition [0006].
Regarding amounts, preferably ready to feed concentrations include especially preferred 100-200 mg/L [0025] (i.e., 0.1-0.2 grams per L, reading on claim 1, k), and overlapping with claim 75, rendering the claimed amounts prima facie obvious)
Sorensen establishes that addition of osteopontin will correspond to amount of OPN in human milk, which would have been expected to improve the Th-1 response, and benefits to certain immune deficiencies [0027]. Therefore, it would have been obvious to include osteopontin in obvious amounts, with the other ingredients of Ao (including obvious addition of alpha-lactalbumin taught by Petta (in amounts similar to comparative proteins based on Ao), giving the elected nutritional formula combination of instant claims 1, including using required amounts of components of the independent and dependent claims. The motivation would have been nutritive formulations, suitable for infant nutrition, with the benefits on the immune system.
Applicant argues, regarding the limitation a combination of galactooligosaccharides, polydextrose, and fructooligosaccharides being 0.1-1.0 g/L (wherein clause of claim 1; lines 22-24), that Ao does not teach any amount of fructooligosaccharide; the only support is [0094], which does not disclose any amount of this component. Applicant further alleges there is nothing in Ao that indicates these three components are functionally interchangeable, motivating dividing 5.1 g of GOS and PDX in half (to result in 0.25 g/L or 0.76 g/L for the sum of all three).
Applicant alleges there is an expert declaration from Cynthia Barbet, Ph.D. The Examiner has reviewed the file, and fails to identify any such declaration. Thus, this alleged evidence is missing, and cannot be given support.
Applicant further argues that amounts corresponding to 0.000676 to .00338 g/L of PDX do not correspond to the amended range 0.2 to 0.4 g/L. Examiner develops the basis for reliance on prebiotic combinations in Tables 4-6, 5.1 g of the combination of GOS and PDX per 100 g formulation (about 0.51 g/L), which render 0.255 g/L as prima facie obvious, based on obviousness of half of the 5.1 g combination / 100 g milk-based formula (i.e., about 0.255 g/L of PDX, clearly within the amended range of (i)). Examiner notes that obvious amounts of PDX + GOS evaluated in this manner, and using the same or similar amount of fructooligosaccharides would render obvious 0.765 for a combination of PDX, GOS and fructooligosaccharide, within the range of the wherein clause of claim 1.
This rationale does not render obvious amounts that differ from the claims by argued “orders of magnitude”. 0.255 g/L is within the range of i) 0.2 to 0.4 g/L PDX; 0.765 g/L is within the range of the wherein clause, 0.1 to 1.0 g/L. Examiner notes MPEP 2123 (I) indicates: A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Labs., Inc. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 13-14, 16, 20, 22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7-12, 15-18 of U.S. Patent No. 11,547,744. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims and the patent claims are drawn to the same ingredient combination as in the instant claims; the patent claims recite specific ranges, whereas instant claim 1 does not; each of the patent claims anticipates instant claim 1, excepting (i), which overlaps, rendering the amounts prima facie obvious (MPEP 2144.05 (I): 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)). Instant dependent claims each limit amounts, which overlap with amounts in the patent claims, rendering obvious the instant claims from the patent claims.
Applicant argues: instant claim 1 has been amended now requiring polydextrose to be present in an amount of 0.2 to 0.4 g/L of reconstituted, ready-to-use nutritional formula, believed to support a ground for nonobviousness.
This is not persuasive. Component (i) of patent claim 1 recites concentration of 0.1 to 0.5 g of polydextrose per L of the nutritional formula, which overlaps with 0.2 to 0.4 g/L, rendering the instant claims obvious over the patent claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIMOTHY P THOMAS whose telephone number is (571)272-8994. The examiner can normally be reached M-Th 6:30-5:00.
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TIMOTHY P. THOMAS
Primary Examiner
Art Unit 1614
/TIMOTHY P THOMAS/Primary Examiner, Art Unit 1614
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