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 .
Election/Restrictions
Applicant’s election of Group I, claims 1-28, 30-65, 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)).
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Claims 66-67 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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Claims 3-5, 8, 11, 34-35, 37, 55, 64, 75-81 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.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, 27-28 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 claim 28, the amount of polydextrose may be 0.1 mg to 0.5 mg/100kcal [0116], corresponding to 0.000676 to 0.00338 g/L, overlapping with the claimed range, rendering the claimed range prima facie obvious (MPEP 2144.05 (I)).
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).
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 that the references were cited in the parent application, and that full faith and credit are to be given to the prosecution in the parent application. The Examiner is unclear what is the point of this statement. The instant and patented parent claim are not the same. Thus, the instant rejection is based on different criteria of the instant claims relative to the parent. Applicant argues that Ao does not disclose or suggest alpha-lactalbumin enriched whey protein concentrate, OPO triglyceride, galactooligosaccharides, polydextrose, fructooligosaccharides and osteopontin in newly recited ranges.
This is not persuasive. Alpha-lactalbumin is taught as an alternative to target protein comparative to lactoferrin. Additionally, Petta clearly focus on benefits of alpha-lactobumin enriched whey protein as a nutrition source. Considerations of Petta and Ao together render obvious amounts and relative amounts required by amended claim 1.
OPO triglyceride is taught by Ao, and amounts taught suggest the claimed conccntration; see rejection for basis.
A combination of galactooligosaccharides & polydextrose is taught in Table 6. The amount of the combination renders about half of each in individual amounts, rendering obvious the newly claimed concentration. Fructooligosaccharides is also taught. Table 6 amounts for the prebiotic combination render obvious about half this amount for fructooligosaccharides amount.
Ao does not teach osteopontin. But the additional reference Sorenson establishes this component is considered essential, a component which would have been expected to improve the Th-1 response, and benefits to certain immune deficiencies; amounts are also obvious from Sorenson considerations, see rejection basis.
Applicant argues that Petta does not teach all of the items argued with respect to Ao. Petta is relied on to emphasize the benefits of alpha-lactalbumins enriched whey proteins, and to provide concentration guidelines, rendering obvious the amounts of claim 1 a). In addition to muscle benefits of Petta, Ao clearly teaches alpha-lactalbumins enriched whey proteins. Petta is not relied on for other components argued.
Applicant argues Sorensen does not teach or suggest the same argued components above. This is not accurate. Sorensen clearly teaches the benefits of osteopontin in infant formulae, namely 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. Sorensen provides guidelines for amounts, rendering obvious the claimed concentration range of claim 1, k). Sorensen is not relied on for other components argued.
Applicant argues ingredients in cited references are not interchangeable, citing a reference from 2023. Examiner notes that publication in 2023 postdates the application, and would not have been considered at the time of the effectively filed application. All components required by claim 1 are taught by Ao, with the exception of osteopontin. The teachings of Sorensen include: 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. The essential component rationale would have motivated addition of this component. Therefore, the obvious claimed formulation is not simply a recipe of unrelated components, “not interchangeable”.
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, 27-28 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. Instant dependent claims each limit amounts, which overlap with amounts in the patent claims, rendering obvious the instant claims from the patent claims.
Applicant requests the rejection be held in abeyance.
The Examiner notes that MPEP 804 (I) (B) (1) indicates:
A complete response to a nonstatutory double patenting rejection (also called an "obviousness-type" or ODP rejection) is either a reply by applicant showing that the claims subject to the rejection are patentably distinct from the reference claims or the filing of a terminal disclaimer in accordance with 37 CFR 1.321 in the pending application(s) with a reply to the Office action (see MPEP § 1490 for a discussion of terminal disclaimers). Such a response is required even when the nonstatutory double patenting rejection is provisional.
…
As filing a terminal disclaimer, or filing a showing that the claims subject to the rejection are patentably distinct from the reference application’s claims, is necessary for further consideration of the rejection of the claims, such a filing should not be held in abeyance. Only objections or requirements as to form not necessary for further consideration of the claims may be held in abeyance until allowable subject matter is indicated.
Neither arguments that the claims are patentably distinct over each other, nor the filing of a terminal disclaimer reply options have been pursued. Applicant is cautioned that a request to hold the ODP rejection in abeyance is not considered a complete response.
Additionally, the Examiner notes that the rejection is not even provisional.
Conclusion
No claim is allowed.
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.
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.
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, Ali Soroush can be reached at (571)272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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TIMOTHY P. THOMAS
Primary Examiner
Art Unit 1614
/TIMOTHY P THOMAS/Primary Examiner, Art Unit 1614
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