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 .
Status of the Claims
Claims 1-14 are pending. Claims 1-7 have been withdrawn from consideration. The previous claim objections have been withdrawn in view of applicant’s amendments to the claims. The previous 112(b) rejections have been withdrawn in view of the remarks and applicant’s amendments to the claims.
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.
Claims 7-9 and 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Ao (US 2017/0006898 A1).
Regarding claims 7 and 12, Ao discloses administering to a subject a nutritional composition which includes up to 7g/100 kcal of a fat or lipid, up to 5g/100 kcal of a protein (Abstract). Ao discloses the composition comprises at least one carbohydrate, such as lactose, from about 9g-14g/100 kcal [0114] which overlaps with the claimed range of up to about 11.4g/100 kcal. The up to 7g/100 kcal of fat disclosed by Ao overlaps with the claimed range of up to about 6.0g/100 kcal of fat. The up to 5g/100 kcal of protein disclosed by Ao overlaps with the claimed range of up to about 4.5g/100 kcal protein. 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).
Ao discloses the source of the protein may be bovine milk protein sources such as milk protein powders, milk protein concentrates, milk protein isolates [0106], which meets the claim limitation: wherein the protein comprises dairy proteins.
As to the claim limitation: where about 0.8g-1.2g/100 kcal of the protein is sourced solely from whole milk, Ao discloses the protein up to 5g/100 and that the protein source may be at least one of soy protein, hydrolyzed protein, amino acids and bovine milk protein sources [0106]. It would have been obvious to one of ordinary skill in the art to have selected a combination of protein sources as disclosed by Ao including a bovine milk protein source. Therefore the combination of protein sources would comprise a bovine milk protein source at less than 5g/100 kcal of total protein in the nutritional composition. The less than 5g/100 kcal of the bovine milk protein source is considered to meet the claim limitation of where about 0.8g-1.2g/100 kcal of the protein source is sourced solely from whole milk since bovine milk is considered whole milk and the less than 5g/100 kcal of the bovine protein source encompasses the claimed range of 0.8-1.2g/100 kcal protein from whole milk. 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).
As to the claim limitation: where about 0.8g/100 kcal to about 1.5g/100 kcal of the fat comprises milk fat sourced solely from whole milk, Ao discloses the fat up to 7g/100 kcal [0132] where the suitable fats include milk fat, cream, butter (all sourced from whole milk), fish oils, plant oils, medium chain triglyceride oils, structured lipids or combinations thereof [0131]. It would have been obvious to one of ordinary skill in the art to have selected a combination of fats as disclosed by Ao, including a combination of those sourced from whole milk (milk fat, cream, butter) and those not sourced from whole milk (fish oils, plant oils). Therefore the combination of fat would comprise fat sourced from whole milk in an amount less than the 7g/100 kcal disclosed by Ao, which is considered to meet the claim limitation of where about 0.8g/100 kcal to about 1.5g/100 kcal of the fat comprises milk fat sourced solely from whole milk since the less than 7g of fats sourced from whole milk of Ao encompasses the claimed range of 0.8-1.5g/100 kcal fat sourced from whole milk. 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).
Regarding the claim language “for supporting and promoting nutrition in a pediatric subject,” this limitation is deemed to be an intended use so far as the process is concerned. In process claims, a claimed intended use must result in a manipulative difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. MPEP 2111.02. Given that the method of administering a nutritional composition of Ao is identical to that of the presently claimed in terms of process, it meets the intended use of the claimed method.
Additionally, Ao discloses the nutritional composition of the disclosure, when administered to a pediatric subject, can provide broad benefits in terms of intestinal health, immunity, healthy growth and brain development [0197]. Additionally Ao discloses a nutritional composition means a substance or formulation that satisfies at least a portion of the subjects nutrient requirements [0027], which is considered equivalent to “supporting or promoting nutrition.”
Regarding claim 8, Ao discloses up to 5g/100 kcal of a protein (Abstract) in the nutritional composition and that the protein source may be soy protein, hydrolyzed protein, amino acids and bovine milk protein sources or combinations thereof [0106]. Ao discloses the milk protein source of the nutritional composition can be whole milk [0190].
Regarding the quantity of whole milk of claim 8, Ao does not disclose the amount of whole milk in the nutritional composition. Ao discloses fat up to 7g/100 kcal of the nutritional composition (Abstract). However, it is known in the art that the quantity of whole milk is a result effective variable, change the amount of whole milk and the amount of protein and the calories provided by protein in the nutritional composition changed. It has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value of a result effective variable. Additionally, 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. MPEP 2144.05 II A. As such, the quantity of whole milk recited in claim 8 is merely an obvious variant of the prior art.
Further, attention is invited to In re Levin, 84 USPQ 232 and the cases cited therein, which are considered in point in fact situation of the instant case. At page 234, the Court stated as follows:
This court has taken the position that new recipes or formulas for cooking food which involve the addition or elimination of common ingredients, or for treating them in ways which differ from the former practice, do not amount to invention, merely because it is not disclosed that, in the constantly developing art of preparing food, no one else ever did the particular thing upon which the applicant asserts his right to a patent. In all such cases, there is nothing patentable unless the applicant by a proper showing further establishes a coaction or cooperative relationship between the selected ingredients which produces a new, unexpected and useful function. In re Benjamin D. White, 17 C.C.P.A. (Patents) 956, 39 F.2d 974, 5 USPQ 267; In re Mason et al., 33 C.C.P.A. (Patents) 1144, 156 F.2d 189, 70 USPQ 221.
Regarding claim 9, Ao discloses bovine milk proteins, amino acids, hydrolyzed protein in the alternative to soy protein [0106]. Soy protein is not required and it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to selected bovine milk proteins, amino acids, and/or hydrolyzed proteins without including soy protein since Ao discloses soy protein is optional. Therefore soy protein is not required and the nutritional composition of Ao is considered to be substantially free of plant derived proteins.
Regarding claim 13, Ao discloses the carbohydrate from 9-14g/100kcal of the nutritional composition [0114] where the carbohydrate component of the composition may be 100% lactose [0116]. This would result in 9-14g lactose/100 kcal of the nutritional composition, which encompasses the claimed range of lactose at 10.2-11g/100 kcal of the nutritional composition. 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).
Regarding claim 14, Ao discloses the nutritional composition may be an infant formula or a growing-up milk [0160].
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Ao as applied to claim 7 above, and further in view of Kuang (US 2018/0168215 A1), Hondmann (WO 2015/094532 A1).
Regarding claim 10, Ao discloses the inclusion of whole milk [0106] and [0190]. Ao discloses phospholipids from about 6-300 mg/100 kcal in the nutritional composition, which encompasses the claimed range of 7-11mg/kcal. Ao discloses sphingomyelin (a sphingolipid) from about 1-60 mg/100 kcal, which encompasses the claimed range of 1.5-2.5 mg/100 kcal. Ao discloses gangliosides from about 1.1-5.3 mg/100 kcal, which overlaps with the claimed range of 1-2 mg/100 kcal. [0074]. 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).
Ao discloses the nutritional product includes an enriched lipid fraction which comprises CLA (conjugated linoleic acid) and OBCFAs (odd and branched chain fatty acids) [0075]. Ao discloses the enriched lipid fraction contains OBFCAs from 0.3g-6.1g/100 kcal [0077] and CLA from 0.4-2.5g/100 kcal [0079]. Since the enriched lip fraction is one of multiple ingredients in the nutritional composition of Ao, the final concentrations of OBCFAs and CLA in the final nutritional composition will be less than the amounts recited by Ao for the enriched lipid fraction. Therefore the quantities of OBFCAs and CLA recited by Ao, once added to the nutritional composition of Ao, will be less than 6.1g/100 kcal OBCFAs and less than 2.5g/100 kcal CLA, which both encompass the claimed ranges of OBCFAs and CLA. 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).
Ao discloses the inclusion of butyric acid [0096]. Ao does not disclose butyrate or the quantity of butyrate.
Kuang, in the field of administering nutritional compositions to pediatric subjects, discloses the nutritional compositions can be infant formulas or growing up milks [0001] [0029]. Kuang discloses the nutritional composition is used to improve cognitive function in target subjects including promoting optimal and functional synaptic development and other additive and/or synergistic beneficial health effects [0001]. Kuang discloses the source of butyrate can be milk [0068]. Kuang discloses the nutritional composition includes butyrate from 10-150 mg/100 kcal [0064], which encompasses the claimed range of 60-85 mg/100 kcal. 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).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included the butyrate of Kuang in the nutritional composition of Ao since both are drawn to infant formulas which provide nutritional benefits to the subject.
Ao discloses the nutritional composition further includes cholesterol [0075]. Ao does not disclose the quantity of cholesterol.
Hondmann, in the field of nutritional compositions for pediatric subjects, discloses the nutritional composition can be an infant formula [0010]. Hondmann discloses the nutritional composition comprises cholesterol from about 5-25 mg/100 kcal of the nutritional composition [0008] [0116], which encompasses the claimed range of 5.5-9.5 mg/100 kcal. Hondmann discloses the cholesterol source is milk or other dairy products [0117]. 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).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the cholesterol in the nutritional composition of Ao with the quantity of cholesterol in the nutritional composition of Hondmann since both are drawn to infant formulas which provide nutritional benefits to the pediatric subjects.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Ao as applied to claim 7 above, and further in view of Van der Beek (US 2018/0310605 A1).
Regarding claim 11, Ao discloses suitable fats or lipids for the nutritional composition include structured lipids which include palmitic acid enriched in the sn-2 position of triglycerides [0131].
Ao does not disclose the proportion of palmitic acid in the sn-2 position of the triglyceride.
Van der Beek, in the field of infant formulas, discloses 3-7g lipids per 100 kcal of the nutritional composition, 1.25-5 g protein per 100 kcal and 6-18g carbohydrate per 100 kcal of the nutritional composition [0011]. Van der Beek discloses the lipid comprises triglycerides wherein at least 15% of the palmitic acid is present at the sn-2 position of the triglycerides [0017]. Van der Beek further discloses the nutritional composition with at least 15% of the palmitic acid present at the sn-2 position of the triglycerides improves postnatal growth trajectory or body development of the infant [0017].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the triglycerides with palmitic acid enriched in the sn-2position of Ao with the at least 15% of palmitic acid present at the sn-2 position of the triglyceride of Van der Beek because both are drawn to infant formulas comprising triglycerides enriched in palmitic acid in the sn-2 position and Van der Beek discloses levels about 15% of palmitic acid present at the sn-2 position of the triglyceride improve postnatal growth trajectories or body development of the infant.
The at least 15% of palmitic acid present at the sn-2 position of the triglyceride of Van der Beek encompasses the claimed range of 34-36% palmitic acid at the sn-2 position of the triglyceride. 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).
Response to Arguments
Applicant's arguments filed 12 March 2026 have been fully considered. To the extent they apply to the above rejection they are not persuasive.
Applicant argues the disclosure of the present application relates to the use of whole milk as the source of milk fat in the nutritional composition. The present disclosure relies on the use of the 'native matrix' of the whole milk to deliver the milk fat. The standards of identity for the "Whole Milk" and "Dry Whole Milk" ingredient that is used herein is therefore distinct from that of other dairy protein powders and should not be used interchangeably. Thus, the milk fat is an inherent part of the whole milk (i.e., it has not been separated, enriched, or further processed). Remarks pp9-10.
This argument is not persuasive. Claim 7 recites fat contributed by a fat source where the fat comprises milk fat sourced solely from whole milk. This claim language does not require whole milk as an ingredient, rather it requires the fats be sourced from whole milk. Any milk fat is considered sourced from whole milk. The fat in butter is sourced from whole milk, the fat in cream is sourced from whole milk, etc.
Applicant argues Ao is directed towards buttermilk as a vehicle for including lipids and not directed toward whole milk as a fat source. Remarks p10.
This argument is not persuasive. As discussed above, any milk fat is considered to meet the claim limitation of a fat sourced from whole milk. Ao discloses the milk protein source of the nutritional composition can be whole milk, which would also supply fat [0190].
Applicant argues a portion of the protein of claim 7 must be sourced solely from whole milk, which Ao does not teach Applicant argues the bovine milk proteins, whey protein, etc. disclosed by Ao does not satisfy the claim limitation of dairy protein sourced solely from whole milk. Remarks pp10-11.
This is not persuasive for the same reasons as above in reference to fat sourced from whole milk. The claim language does not require whole milk as an ingredient, rather it requires the proteins be sourced from whole milk. Any dairy protein is considered sourced from whole milk. The protein in non-fat milk is sourced from whole milk, the protein in milk protein powder is sourced from whole milk, etc.
Applicant argues the disclosure of whole milk by Ao in paragraph [0190] refers only to whole milk as a source for lactoferrin and therefore Ao does not disclose whole milk as a composition ingredient. Remarks pp12-13.
This argument is not persuasive. Ao paragraph [0102] recites whole milk as a source of lactoferrin. Ao paragraphs [0106] and [0190] both recite whole milk as an ingredient in the nutritional composition as a source of protein.
Applicant argues Ao does not disclose the claimed ranges from whole milk. Ao discloses rages for protein and fat but does not specify the amount of fat and protein sourced solely from whole milk as opposed to other ingredients (dairy powders, buttermilk, etc.). While the instantly claimed ranges reflect a carefully optimized formulation. Remarks pp13-14.
This argument is not persuasive. As discussed above, all milk fats and dairy proteins are considered to meet the claim limitation of: sourced solely from whole milk. Therefore the protein and fat disclosed by Ao along with the disclosure of whole milk as a protein source ingredient make it obvious to include dairy proteins and milk fats at the rates disclosed by Ao. As discussed in the claim 7 rejection above, Ao discloses the protein up to 5g/100 and that the protein source may be at least one of soy protein, hydrolyzed protein, amino acids and bovine milk protein sources [0106]. It would have been obvious to one of ordinary skill in the art to have selected a combination of protein sources as disclosed by Ao including a bovine milk protein source. Therefore the combination of protein sources would comprise a bovine milk protein source at less than 5g/100 kcal of total protein in the nutritional composition.
Ao discloses the fat up to 7g/100 kcal [0132] where the suitable fats include milk fat, cream, butter (all sourced from whole milk), fish oils, plant oils, medium chain triglyceride oils, structured lipids or combinations thereof [0131]. It would have been obvious to one of ordinary skill in the art to have selected a combination of fats as disclosed by Ao, including a combination of those sourced from whole milk (milk fat, cream, butter) and those not sourced from whole milk (fish oils, plant oils). Therefore the combination of fat would comprise fat sourced from whole milk in an amount less than the 7g/100 kcal disclosed by Ao.
Applicant argues impermissible hindsight reconstruction in order to select whole milk from Ao’s extensive menu of protein and fat sources. Remarks p14.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). In the instant case Ao disclose whole milk as an ingredient in the composition and protein and fat levels that encompass or overlap with the claimed ranges and as discussed above all dairy proteins and milk fats are sourced solely from whole milk.
Applicant argues “As one of ordinary skill in the field of infant nutrition would readily understand, this (selecting the claimed ingredients and ranges of the instant claims from Ao) would be impossible to achieve unless one excludes the vegetable oils and structured lipids that Ao prominently discloses, and then use whole milk at levels contributing the specific claimed ranges of protein and milk fat, i.e. the use of the two ingredients would be mutually exclusive.” Remarks p14).
This argument is not persuasive. The instant claims are drawn to administering a nutritional composition “comprising” the recited ingredients. Therefore the nutritional composition of the instant claims and the prior art can have additional ingredients. It is unclear from the argument presented why the disclosure of Ao would render the use of whole milk and vegetable oils and structured lipids mutually exclusive.
Applicant argues Ao teaches away from the rejected claims. Ao discloses reliance on skim milk as a source of protein which is supplemented with either vegetable oils and/or lipid enriched dairy fractions, such as buttermilk. While the instant application uses whole milk as a unitary ingredient that simultaneously contributes protein, fat and carbohydrates. Ao requires supplementation with non-whole milk products. One of ordinary skill in the art, reading Ao, would not be motivated to use whole milk as a sole source of milk fat, because Ao' s entire teaching is directed toward achieving MFGM and bioactive lipid delivery through buttermilk and/or enriched lipid fractions. Remarks pp14-15.
This argument is not persuasive. The claims are drawn to a fat content of up to 6g/100 kcal of the nutritional composition, where about 0.8-1.5g of fat/100kcal of the nutritional composition comprises milk fat sourced solely from whole milk. As discussed above, all milk fat is considered sourced from whole milk. Claim 7 does not require whole milk as an ingredient in the composition and since only a portion of the recited fat quantity must be milk fat, other contributing ingredients to the fat content could be those recited by Ao.
Applicant argues Ao’s milk fat, cream and butter are not sourced solely from whole milk. Applicant argues milk fat sourced solely from whole milk means the milk fat remains in its native state as part of the whole milk. Not separated and added as isolated ingredients. Applicant argues the milk fat globule membrane is disrupted upon the processes used to produce enriched fractions like buttermilk, etc. Remarks pp15-16.
This argument is not persuasive. They claims do not recite the milk fat globule membranes as an ingredient of the nutritional composition, merely milk fat sourced solely from whole milk. Any fat found in whole milk will meet this claim limitation. As claim 7 is currently recited whole milk is not required as an ingredient of claim 7 and neither is milk fat in its native state.
Applicant argues claim 9 is not obvious over Ao. The present application teaches the composition can use whole milk together with whey protein concentrate and demineralized whey as dairy protein sources without the need for plant proteins. Remarks pp16-17.
This argument is not persuasive. As discussed in the claim 9 rejection above, Ao discloses bovine milk proteins, amino acids, hydrolyzed protein in the alternative to soy protein [0106]. Soy protein is not required and it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to selected bovine milk proteins, amino acids, and/or hydrolyzed proteins without including soy protein since Ao discloses soy protein is optional. Therefore soy protein is not required and the nutritional composition of Ao is considered to be substantially free of plant derived proteins.
Applicant argues claim 10 requires the recited fats be contributed by the whole milk’s milk fat to the nutritional composition. These bioactive components are delivered naturally through the whole milk's native milk fat at specific levels, rather than through supplementation with buttermilk (as in Ao), exogenous butyrate (as in Kuang), or added cholesterol (as in Hondmann). The specification at paragraphs [0006], [0010], [0047]-[0051] demonstrates that these specific ranges are achieved through the inclusion of whole milk at about 3-5 g/100 kcal, providing a simplified, cost-effective formulation that naturally delivers the full complement of milk fat bioactives. Remarks pp17-18.
This argument is not persuasive. Claim 10 depends from claim 7, neither of which require whole milk as an ingredient (as claim 8 does). Ao in view of Kuang and Hondmann. Ao discloses the inclusion of whole milk [0106] and [0190]. Ao discloses phospholipids, sphingomyelin (a sphingolipid), and gangliosides from sourced from buttermilk (which meets the claim limitation of sourced from whole milk) [0074].
Ao discloses the nutritional product includes an enriched lipid fraction which comprises CLA (conjugated linoleic acid) and OBCFAs (odd and branched chain fatty acids) [0075]. As disclosed in the specification, milk is a known source of OBCFA’s and CLA [0048].
Kuang, in the field of administering nutritional compositions to pediatric subjects, discloses the nutritional compositions can be infant formulas or growing up milks [0001] [0029]. Kuang discloses the nutritional composition is used to improve cognitive function in target subjects including promoting optimal and functional synaptic development and other additive and/or synergistic beneficial health effects [0001]. Kuang discloses the source of butyrate can be milk [0068].
Hondmann, in the field of nutritional compositions for pediatric subjects, discloses the nutritional composition can be an infant formula [0010]. Hondmann discloses the nutritional composition comprises cholesterol [0008] [0116]. Hondmann discloses the cholesterol source is milk or other dairy products [0117].
Applicant argues the claimed ranges are narrow and optimized while the prior art discloses broader ranges. Remarks pp18-19.
This argument is not persuasive. As discussed in the claim 10 rejection above, unless applicant demonstrates the criticality of the claimed 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).
Applicant argues one of ordinary skill would not combine Ao, Kuang and Hondmann because they are drawn to different technical problems. Remarks p19.
This argument is not persuasive Ao, Kuang and Hondmann are all drawn to the common field of infant formulas or growing up milks.
Applicant argues, with respect to claim 11, the Van der Beek relies on an engineered blend of vegetable fats and fractionated or processed milk fat fractions; not whole milk itself as in the current application. Applicant argues the ranges disclosed by Van der Beek are broader than the instant claims. Remarks pp20-22.
This argument is not persuasive. Van der Beek discloses an infant formula which comprises 10-70 wt% based on total lipid of mammalian milk lipid derived from the group consisting of butter, butter fat, butter oil and anhydrous milk fat where the lipid comprises triglycerides that comprise at least 15% of the palmitic acid is present at the sn-2 position of the triglycerides [0011-0012]. Van der Beek does not require the triglycerides be engineered. As applicant discloses in the specification, bovine milk fat comprises triglycerides with palmitic acid in the sn-2 position [0044].
As to the broadness of Van der Beek’s ranges versus the narrowly claimed ranges, Applicant has not demonstrated the criticality of the claimed range. Therefore the at least 15% of palmitic acid present at the sn-2 position of the triglyceride of Van der Beek encompasses the claimed range of 34-36% palmitic acid at the sn-2 position of the triglyceride. 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).
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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/Michele L Jacobson/Primary Examiner, Art Unit 1793
/C.L.G./Examiner, Art Unit 1793
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