Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
2. Applicants’ arguments and amendments filed on 12/19/2025, overcomes the rejections of record, however, the new grounds of rejection as set forth below are necessitated by applicants’ amendment and therefore, the following action is Final.
Any objections and/or rejections made in the previous action, and not repeated below, are hereby withdrawn.
Status of the application
3. Claims 14-18, 21-26, 29-33 are pending in this application.
Claims 14, 15, 22, 23 have been amended.
Claims 14-18, 21-26, 29-33 have been rejected.
Obviousness Double Patenting (ODP)
4. The non-statutory 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 non-statutory 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); Inre 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 non-statutory 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 AlA.
Effective January 1,1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73 (b). 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 non- statutory 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, sub-section |. B.1. Fora reply toa non-final Office action, see 37 CFR1.111(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 e-Terminal Disclaimer may be filled out completely online using web-screens. An e-Terminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about e-Terminal Disclaimers, refer to www. Uspto.gov /patents/apply/applying -online /e-terminal-disclaimer
Claims 14-18, 20-26, 28, 29 of current Application Number 17/474273 are provisionally rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-2,6-9, and 11 of co-pending application 16/518231.
Although the claims at issue are not identical, they are not patentably distinct from each other.
This is a provisional non-statutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The range of dry weight percentage of whey protein micelles required to achieve a daily dose of at least 20 g for claim 1 and “at least 30 gm for claim 6” of co-pending application 16/518,231 overlaps with “at least 30gm of claim 14 of current application 17/474273.
While comparing the co-pending application numbers 16/518,231 with the current application number 17/474273, the common feature is that these two applications share the same invention of making a meal replacement composition comprising whey protein micelle with other proteins e.g., whey protein, carbohydrate, lipid, fiber to provide nutritionally enriched meal composition which may be in the form of liquid also.
The range of dry weight percentage of whey protein micelles required to achieve a meal composition with additional components including 15-50 wt.% total protein of claims 1, 11 of the co-pending application, overlaps with the claimed range of claims 14, 21, 22, 29 and 33 of current application 17/474273.
The range of dry weight percentage of whey protein micelles required to achieve a meal composition with additional components including 15-50 wt.% total protein of claims 1, 11 of the co-pending application 16/518231, overlaps with the claimed range of 33.1 wt. % of protein , 12.9 wt.% lipid, 47.1 wt.% carbohydrate and 6.9 wt.% fibers of claims 21, 29 and identical to 15-50 wt.% protein, 10- 15 wt.% lipids, 25-50 wt.% carbohydrates, and 5-10 wt.% fibers by dry weight of claims 14, 22 of current application 17/474273.
As set forth in MPEP 2144.05, in the case where the claimed range “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).
Claim Rejections - 35 USC § 103
5. The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
6. The factual enquiries set forth in Graham v. John Deere Co., 383 U.S. 1,148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S. C. 103(a) are summarized as follows:
a. Determining the scope and contents of the prior art.
b. Ascertaining the differences between the prior art and the claims at issue.
c. Resolving the level of ordinary skill in the pertinent art.
d. Considering objective evidence present in the application indicating obviousness or non-obviousness.
7. Claims 14-18, 22-26, 31, 32 are rejected under 35 U.S.C. 103(a) as being unpatentable over Mateus et al. US 2011/0250310 in view of Schmitt et al. EP 1839492 and further in view of Bovetto et al. US 2009/0035437.
8. Regarding claims 14 and 22, Mateus et al. discloses a nutritional composition containing carbohydrate, lipid, protein, fiber etc. ([0047], [0049], [0075], [0093], [0098], and [0099]). Mateus et al. also discloses that the protein includes 60- 100% whey protein, preferably 100% of the total protein in the composition ([0075], [0080], and [0092]) and whey protein micelle can be up to 100% of the whey protein ([((0101]) in the composition. Mateus et al. also discloses that this whey protein is used as whey protein micelle (WPM) or Whey protein isolate (WPI) or combinations ([0019]) which helps to lose weight and induces to gain lean protein mass in the body ([0081], [0096]), therefore can be used to treat or prevent weight gain of an individual including obese patients also ([0077], [0078], [0081], [0112], [0117], [0121]). If we consider the disclosure of Mateus et al. as a whole, Mateus et al. discloses that whey protein micelle and/or whey protein isolate (WPI) or combinations ([0019]) provide the benefit of weight reduction and is applicable to treat obese also ([0081], [0121]). Mateus et al. also discloses whey protein micelles can be in liquid or in dry form and are used in a great variety of applications ([0106]).
Mateus et al. discloses that the amounts of the ingredients are based on the total weight of the composition ([0016], [0037]) and the composition can be orally and preferably liquid ([0128]). Therefore, the amounts of ingredients per 100 gm weight can be based on dry weight if it is dry composition. It is also to be noted that Mateus et al. discloses that water can be varying amounts present in the composition ([0137], [[0140]). As the amount of water varies and if we consider water in terms of weight for liquid composition as disclosed by Mateus et al. ((0137], [0140]), it is within the skill of a skilled artisan to make dry ingredient from the disclosed range as discussed above which will meet the claimed range and would dilute with water to make final liquid composition.
Mateus et al. discloses whey protein (includes whey protein micelle) is the source of high amounts of essential amino acids e.g., leucine, cysteine and these amino acids are suitable for weight management and satiety ([0077], [0078]) and whey protein in the diet. As whey protein (includes whey protein micelle, WPM) (WPM is used at least 13.5gm/100 gm is in Mateus et al. at least in [(0134]) is the source of high amounts of essential amino acids e.g., leucine, cysteine, therefore, whey protein in the diet brings high level of amino acid in blood as hyper-aminoacidemia. It is also to be noted that the administration of nutritional composition as oral supplement and as meal in order to control weight etc.
Although Mateus et al. discloses both the WPM and WPI, and also discloses the composition made using WPM (at least in [0134]), however, more specifically, Schmitt et al. discloses that WPM is arranged in such a way that the hydrophilic parts of the
proteins are oriented towards the outer parts of the agglomerate and the hydrophobic parts of the protein are oriented towards the inner of the micelle so that this makes organoleptically favorable configuration which offers good stability also in hydrophilic environment ([0030], [0031]). Schmitt et al. also discloses that WPM has other common nutritional benefits like whey protein including high PER ([0038]- [0041]) in addition to its organoleptically favorable configuration which offers good stability also in hydrophilic environment ([0030], [0031]). Schmitt et al. also discloses that WPM helps to enhance muscle development, muscle maintenance in children, adults and elderly persons (at least in [0078]).
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Mateus et al. to select WPM as taught by Schmitt et al. because Schmitt et al. discloses that WPM is arranged in such a way that the hydrophilic parts of the proteins are oriented towards the outer parts of the agglomerate and the hydrophobic parts of the protein are oriented towards the inner of the micelle so that this makes organoleptically favorable configuration which offers good stability also in hydrophilic environment ([0030]).
However, Mateus et al. in view of Schmitt et al. do not specifically mention “wherein the whey protein micelles are administered to the obese subject to induce a delayed gastric emptying and/or a delayed postprandial amino acid appearance in blood of the obese subject as compared to administration of native whey proteins in combination with the meal to the obese subject”.
Claims 14, 22 are broad. Mateus et al. has also broad disclosure. For example, Mateus et al. discloses that the composition can include any effective amount including the disclosed amount of at least about 9gm/l00g ([0015], [0037], [0134] or if we consider a specific example which is whey protein micelle, (WPM) (WPM is used at least 13.5g/100 gm is in Mateus et al. at least in [0134]) which is considered a disclosed broad range value of WPM which shows prima facie case of obviousness.
It is also to be noted that the primary reference does not fail to suggest the recited WPM. The reason is, at this time, the broadly disclosed range amount overlaps the broadly disclosed claimed amount of WPM which shows prima facie case of obviousness. If we consider the amount of WPM from the disclosure (greater than 13.5g/100gm in [0134]) and to evaluate the daily consumption of liquid which is expected to be reasonable to have 250 ml liquid consumption for an individual (if we consider lower 13.5gm WPM/100gm from [0134] of Mateus et al., then it will be “at least 30 gm weight per day). This is also within the skill of one of ordinary skill in the art to optimize it. This is also been addressed using Result Effective Variable below.
Absent showing of unexpected results, the specific amount of 30 gm daily WPM consumption (is equivalent to at least 15 wt.%, in applicant’s spec) in the diet is not considered to confer patentability to the claims. As the liquid consumption having greater than 13.5g WPM/100mlI are variables that can be modified, among others, by adjusting the amount of WPM in the liquid nutritional composition from broadly disclosed at least 13.5gm WPM ((0134], Mateus et al.), the precise amount would have been
considered a result effective variable by one having ordinary skill in the art at the time the invention was made.
As such, without showing unexpected results, the claimed amount cannot be considered critical. Accordingly, one of ordinary skill in the art at the time the invention was made would have optimized, by routine experimentation, the amount of percent nutritional liquid consumption ([0134] in Mateus et al.) to have daily WPM at least 30 gm daily dose (which is equivalent to at least 15 wt.% in applicants spec) in Mateus et al., to amounts, including that presently claimed, in order to obtain the desired effect e.g. desired delayed postprandial amino acid appearance (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
In addition, examiner used an additional secondary prior art by Bovette et al. in order to establish the superiority of WPM over WPI which will guide one of ordinary skill in the art to prefer WPM containing nutritional composition over WPI and/or other derivatives as disclosed by Mateus et al.
Bovetto et al. discloses that whey protein in the form of whey protein micelle is
used to control diabetes by controlling blood glucose of children, elderly and adult human individual ( [0065], [0066]) and whey protein is an excellent source of amino acids ([0064]) and is used in many diet composition ([0097], e.g. diet fortification, etc.) . Bovetto et al. also discloses that WPM is superior form of whey protein derivative in relation to its stability, taste etc. ([(0133]) and restoring the excellent protein quality equivalent to the starting whey protein from which it is derived ([0064]-[0066] e.g. in [0066], it is 118 PER, is evaluated by PER value which is 100-110 e.g. in [(0108]) and it can be used as WPM concentrate as WPM powder as pure form of WPM ([0100], [0106]).
One ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Mateus et al. to consider the teaching of Bovetto et al. to include WPM as preferred choice over other whey protein derivatives including WPI because WPM is superior form of whey protein derivative in relation to its stability, taste etc. ([(0133]) and restoring the excellent protein quality equivalent to the starting whey protein from which it is derived ([0064]-[0066] e.g. in [0066], it is 118 PER, is evaluated by PER value which is 100-110 e.g. in [(0108]) and it can be used as WPM concentrate as WPM powder as pure form of WPM ([0100], [0106]).
9. Regarding claims 15, 23, Mateus et al. also discloses that the composition can include Whey protein isolate, whey protein micelle or any combinations thereof (at least in [0019]). Regarding a daily dose of at least 30 g WPM which is claimed in amended claim 14, in terms of percent amount it is evidenced from the specification ([0031]) that this can be equivalent to at least 15%, preferably 20% WPM in the total dry weight of the food composition ([0031] in PGPUB). Therefore, rest can be whey protein isolate.
Therefore, one of ordinary skill in the art may consider the combinations of WPI and WPM where meal protein can be included with WPI (at least in [0019], [0093]) in order to have both types to contribute desired textural and sensual properties in presence of both of them in the composition.
10. Regarding claims 16, 24, Mateus et al. discloses whey protein (includes whey protein micelle) is the source of high amounts of essential amino acids e.g., leucine, cysteine and these amino acids are suitable for weight management and satiety ([0077], [0078]) and whey protein in the diet. (at least in Mateus et al., [0019], [0134]). It has been also discussed that Mateus et al. in view of Bell et al. disclose the amount of WPM to meet claim 14 and discussed above. Therefore, even if Mateus et al. in view of Schmitt et al. do not specifically mention the claim limitation of claim 16, however, as because Mateus et al. in view of Schmitt et al. disclose WPM which the identical WPM of claim 14, and claim 16 depends on claim 14, therefore, the method of administering WPM containing composition of claim 14 would result the identical property including the claimed property of “ ..A delayed postprandial amino acid appearance in the blood of the obsess subject by about 30 minutes ...” as claimed in claims 16, 24.
11. Regarding claims 17, 25, Mateus et al. discloses that the ratio of WPI can be in combination with WPM (at least in [0019]). Regarding a daily dose of at least 30 g WPM which is claimed in amended claim 14, in terms of percent amount it is evidenced from the specification ([0031]) that this can be equivalent to at least 15%, preferably 20% WPM in the total dry weight of the food composition ([0031] in PGPUB). Therefore, rest can be whey protein isolate.
Therefore, one of ordinary skill in the art may consider the combinations of WPI and WPM where meal protein can be included with WPI (at least in [0019], [0093]) in order to have both types to contribute desired textural and sensual properties in presence of both of them in the composition.
12. Regarding claims 18, 26, in brief, Mateus et al. discloses that the WPM can be in the beverage (at least in Mateus et al., [0001]) and beverage, bar etc. (at least in Bell et al., in Abstract).
In more detail, Mateus et al. discloses the nutritional composition is used for any human individual as ‘complete nutrition’ ([0115], [0116], and [0117]) in the form of a nutritionally balanced meal (i.e., solid) also ([0129]). Therefore, the disclosure of ‘preferably liquid’ ([0128]) and “complete nutrition’ ([0115], [0116], [0117]) in the form of a nutritionally balanced meal (i.e., solid) also ([0129]) is interpreted as Mateus et al. discloses all possible types of solid and liquid composition which includes broadly a nutritional composition.
Mateus et al. also discloses that the whey micelle as protein in the composition can be provided with other nutritional ingredients to serve in any form e.g., in the form of a liquid (i.e., Liquid beverage) beverage ((0128], e.g. [(0134]), whey micelle liquid with at least 13.5 gm /100g) or in the form of a nutritionally balanced complete meal ([0129]) where whey protein can be used as whey protein micelle ([0081], [0096]) as discussed above.
13. Regarding claims 31, 32, it is to be noted that even if Mateus et al. in view of Schmitt et al. do not specifically mention the claim limitation of claims 31, 32. However, as because Mateus et al. in view of Schmitt et al. disclose WPM which the identical WPM of claims 31, 32 and claims 31, 32 depend on claims 22 and 14 respectively, therefore, the method of administering WPM containing composition of claims 14 and 22 would result the identical property including the claimed property of “ wherein the delaying the peak of postprandial plasma amino acid concentration comprises inducing a delayed gastric emptying in the subject” as claimed in claim 31 and “wherein the delaying the peak of postprandial plasma amino acid concentration comprises inducing a delayed gastric emptying in the subject” as claimed in claim 32 respectively.
14. Claims 21, 29, 30, 33 are rejected under 35 U.S.C. 103(a) as being unpatentable over Mateus et al. US 2011/0250310 in view of Schmitt et al. EP 1839492 further in view of Bovetto et al. US 2009/0035437 as applied to clams 14, 22, and further in view of Bell US 2002/0150649 and further in view of Gahler et al. US 2008/0027024.
15. Regarding claims 21, 29, 30, 33, the claim limitation of “wherein the combination of the whey protein micelles and the meal comprises 15-50 wt.% proteins, 10-15 wt.% lipids, 25-50 wt.% carbohydrates, and 5-10 wt.% fibers by dry weight”, as claimed in claims 30 and 33 , and also for the claim limitations of “wherein the combination of the whey protein micelles and the meal comprises 33.1 wt.% proteins, 12.9 wt.% lipids, 47.1 wt.% carbohydrates, and 6.9 wt.% fibers by dry weight” as claimed in claims 21 and 29, it is to be noted that Mateus et al. discloses that the nutritional composition comprises, Carbohydrate 15-51 gm/l00g ([0098]), Fat at least about 12 gm/100 gm ([0015], [0023]), amino acid ([0047]), which is also “free amino acid’, fiber in the composition ([0047], [0112]), whey protein in an amount of at least about 9gm/l00g ((0015], [0037], [0134] e.g. in this example, whey protein micelle is used at least 13.5gm/100 gm is in Mateus et al. at least in [0134], [0019]). 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 USPQ90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
However, Mateus et al. is silent about (i) daily dose of ‘whey protein’ as whey protein micelle necessary to consume every day and (ii) amount of fiber necessary in such composition (i) daily dose of ‘whey protein’ as whey protein micelle necessary to consume every day.
With respect to (i), it is to be noted that Mateus et al. discloses that carbohydrate source can be at least one of maltodextrin, corn syrup, oligo-fructose, lactose, fructose [(0098]) which is broad and includes all types of carbohydrates also. Mateus et al. also discloses that whey protein micelle concentrates ([0106], [0134]) provides the benefit of weight reduction and is applicable to treat obese when combined with a low-calorie diet ([0081], [0134]).
Therefore, it would be obvious to one having ordinary skill in the art to modified the Mateus et al. reference to include combining with a low-calorie diet so as to aid in the loss of weight to those in need of such (which would logically follow to be an obese child or adult subject).
Bell discloses that whey protein concentrates in an amount from 1 to about 50 gm protein can also be served as per serving in a nutritional composition ([0012], [0036], in the form of capsules, tablets ([0049]) [0037]) and orally administered daily ([0058]) at least once a day, along with meal, after diner, or between meals in order to control intake of the subsequent meal and satiety to appetite between meals ([0008}).
It is also to be noted that Bell discloses the “nutritional supplement for pediatric obesity” (in Title and Abstract) and the diet can contain carbohydrate having low — glycemic —Index carbohydrate ([0018]) in the composition.
One of ordinary skill in the art would have been motivated to modify Mateus et al. (Mateus et al. e.g. [0081], [0098], [0106], [0134]) to include the teaching of Bell et al. to incorporate low glycemic index carbohydrate containing nutritional supplement for pediatric patient ( in Abstract, [0018] of Bell et al.) as ‘low calorie diet’ in combination with daily dose of ‘whey protein’ (whey protein micelle)’ to administer as protein in meal in order to provide the protein source in meal and also in order to have controlled intake of desired quantity of protein in the subsequent meal and satiety to appetite of the individual ([0008]).
It is also to be noted that Bell discloses the “nutritional supplement for pediatric obesity” (in Title and Abstract) and the diet can contain carbohydrate having low — glycemic —Index carbohydrate ([0018]) in the composition.
One of ordinary skill in the art would have been motivated to modify Mateus et al. (Mateus et al. e.g. [0081], [0098], [0106]) to include the teaching of Bell et al. to incorporate low glycemic index carbohydrate containing nutritional supplement for pediatric patient ( in Abstract, [0018] of Bell et al.) as ‘low calorie diet’ in combination with daily dose of ‘whey protein’ (whey protein micelle)’ to administer as protein in meal in order to provide the protein source in meal and also in order to have controlled intake of desired quantity of protein in the subsequent meal and satiety to appetite of the individual ([0008}).
With respect to (ii), Gahler et al. discloses that fiber blend is administered as dietary supplement ([0061]) in the nutritional composition used as food ([0088]) is used to promote weight loss (Abstract, [0002]) and to control obesity ([0046]- [0049], [0106], [0107], [0130]). Gahler et al. also discloses that the amount of fiber can be 5-15 g/day ([0098], [0099]) and it is 2.5-7.5 g fiber/50 gm carbohydrate ([0087]- [0089]). Mateus et al. discloses that carbohydrate (includes maltodextrin, oligosaccharide etc., i.e., fiber) 15-51 gm/l00g ([0098]) in the diet meal. Bell et al. discloses Carbohydrate 1-75 gm and it is low glycemic carbohydrate ([0016], Table, [0018]).
Therefore, if we consider primary prior art by Mateus et al., who discloses that carbohydrate 15-51 gm/l00g ([0098]), then, fiber can be approximately, 2.5-7.5 gm (in Gahler et al. 2.5-7.5/51 gm carb, Gahler [0087]- [0089]) if we consider upper value of 51 gm carb /100 gm of Mateus et al. However, with the consideration of lower value of fiber, based on lower range amount of carbohydrate (Mateus et al. [0098]), the disclosed range value of fiber overlaps the claimed range value of fiber as claimed in claims 21, 29, 30, 33. 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).
One of ordinary skill in the art would have been motivated to modify Mateus et al. to include the teaching of Gahler et al. to incorporate the fiber blend (FB) in the composition to promote weight loss (Abstract, [0002]) and to control obesity ([0046]- [0049], [0106], [0107], [0130]) and a loss in body fat, reduced body weight, [0130], [0131]). Therefore, Mateus et al. in view of Bell et al., in view of Gahler et al. meet the amounts of all the ingredients as claimed in claims 21, 29, 30, 33. 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).
Given that Mateus et al. in view of Schmitt et al. , Bovetto et al. in view of Bell et al. and Gahler et al. disclose whey protein micelle as preferred superior form of ‘whey protein’ with the meal containing carbohydrate, protein, fat, fiber are beneficial for weight management and obesity which meets the amounts and ingredients as presently claimed and discussed above, it is clear that the whey protein micelles would be capable of performing “treatment of obesity’, presently claimed as required in the above cited portion of the MPEP, and thus, one of ordinary skill in the art would have arrived at the claimed invention. It is also to be noted that the Mateus et al. in view of Gahler et al. in view of Bell et al. disclose the composition which is used for the weight management.
Therefore, the combinations of prior arts disclose an obvious method to use whey micelle containing meal for reducing obesity, increase satiety and/or post prandial energy expenditure in an obese child or adult human subject exhibited by the disclosed composition meet the claimed invention.
Response to arguments
16. Applicants’ arguments (in Remarks, last page) that TD will be premature at this stage related to ODP rejection is considered. However since applicants do not have any further arguments the ODP rejection is maintained at this time.
17. Applicant’s arguments have been considered. However, they are not persuasive and discussed below.
18. Applicants argued that The cited references, alone or in combination, fail to establish obviousness of either of these claimed inventions because applicants have provided the unexpected result of a meal replacement comprising 30 gram of whey protein micelle “ (in Remarks, page 2, second and fourth paragraphs)”.
In response,
(a) Examiner used only 30 gram dry weight whey protein micelle and showed its effect and also compared to other whey protein derivatives including whey protein isolate (WPI) to establish the superiority of WPM over other whey protein derivatives (at least in PGPUB [0035]). However, there are deficiencies in establishing criticality of WPM as presented in detail in the last two office actions (Final Rejection mailed 6/24/2025 and NF mailed 9/15/2025, SEE under “Response to Arguments”) and discussed briefly below.
(b) It is to be noted that applicant is claiming the criticality of one value 30gm WPM (in PGPUB [0035]). There are no lower and upper data points in the experimental results outside of the claimed one ‘30 gm WPM’ data point to show that “30 gm” is critical (in PGPUB [0035]) as claimed in clams 14, 22. Therefore, arguments with regards to the criticality of the 30 g per dry weight have not been found persuasive in order to show the criticality of the claimed 30 gm WPM as claimed in clams 14,22. In re Hill 284 F.2d 955, 128 USPQ 197 (CCPA 1960). See MPEP 716.02(b) (I). It is to be noted that the evidence of unexpected results must be clear and convincing. In re Lohr 137 USPQ 548.
Therefore, putting similar but different derivatives as different chemicals (WPM vs WPI), e.g. into a body one would have an obvious expectation of having a similar but slightly different result, which is shown by applicant’s results. Therefore, applicant’s results are not considered as unexpected result.
(c ) It is also to be noted that even if it were to be construed that the teaching of Mateus that teaches both WPM and WPI, is considered to be the closest teaching of the prior art the examiner does not agree that applicants evidence shows superiority of WPM over WPI (dose of 30 gm ) in terms of the differences in results are unexpected, unobvious and of both a statistical and practical significance as required by MPEP 716.02 (b) I.” In this instance, the results presented in Figs 1- 4 (Applicant’s specification) do not seem to be significantly recognizable difference having practical significance (in specification, in Figs 1-3).
For example, as shown by applicants’ data both WPM and WPI increase the essential amino acids (i.e. hyper aminoacidemia) from 0 minutes until around 90-120 minutes at a similar but not exact rate and then start to decrease in concentration at 90-120 minutes again at similar but not exact rates (in Fig 1 in PGPUB [0018]) and the trend is same for only amino acid leucine (Fig 2, in PGPUB [0004], [0018]). The only difference being a slight pause for WPM up to 120 minutes before decreasing and start decreasing after 120 minutes (Figs 1, 2). However, this pause is also seen in WPH so it is not unexpected or new when considering similar materials(Fig 3). It is also to be noted that WPI has a higher aminoacidemia whereas WPM seems to have a slightly delayed peak so both their respective benefits when compared to the other.
It is therefore the examiner’s position that WPM is behaving one of ordinary skill in the art would expect and in an obvious manner either WPM or WPI based on applicant’s presented data in the specification.
According to MPEP 716.02 (b) section I “The evidence relied upon should establish "that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance." Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992) See also In re Eli Lilly, 902 F.2d 943, 14 USPQ2d 1741 (Fed. Cir. 1990) as discussed in MPEP § 716.02(c).
19. Regarding the affidavit filed 6/21/2024, the Examiner agrees that the experiment performed using healthy individual only is applicable and can be included to obese children and adults (item #6) and there is no issue related to calculations (item #8,9) and the composition including water (item #7) as long as the comparison is made under identical condition . It is agreed that the composition comprising 7.2% is equal to 30 gm WPM or WPI mentioned in item #8 and in PGPUB [0035]. It is also agreed that the value of 33.1% by weight falls within the claimed range of 15-50% by weight protein of total dry weight according to claims 1, 8 as mentioned in item #9. As discussed above, however, the comparison is made considering identical composition when compared WPM with WPI or WPH. As discussed above, examiner’s position is to include more points outside the higher and lower value with respect to specific 30 gm WPM (or WPI, or WPH) in order to establish criticality of 30 gm point under identical composition. It is also agreed that the value of 33.1% by weight falls within the claimed range of 15-50% by weight protein of total dry weight according to claims 1, 8 as mentioned in item #9.
20. Examiner also mentioned on page 20 (last final office action, mailed 6/24/2025) that Examiner considering another relevant prior art by Bovetto et al. US 2009/0035437 in order to establish the superiority of WPM over other whey derivatives including WPI. Examiner has considered Bovette et al. as an additional prior
in order to establish the superiority of WPM over WPI which will guide one of ordinary skill in the art to prefer WPM containing nutritional composition over WPI and/or other derivatives as disclosed by Mateus et al. In brief, Bovetto et al. also discloses that WPM is superior form of whey protein derivative in relation to its stability, taste etc. ([(0133]) and restoring the excellent protein quality equivalent to the starting whey protein from which it is derived ([0064]-[0066] e.g. in [0066], it is 118 PER, is evaluated by PER value which is 100-110 e.g. in [(0108]) and it can be used as WPM concentrate as WPM powder as pure form of WPM ([0100], [0106]).
One ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Mateus et al. to consider the teaching of Bovetto et al. to include WPM as preferred choice over other whey protein derivatives including WPI because WPM is superior form of whey protein derivative in relation to its stability, taste etc. ([(0133]) and restoring the excellent protein quality equivalent to the starting whey protein from which it is derived ([0064]-[0066] e.g. in [0066], it is 118 PER, is evaluated by PER value which is 100-110 e.g. in [(0108]) and it can be used as WPM concentrate as WPM powder as pure form of WPM ([0100], [0106]).
21. Regarding the arguments in relation to “Impermissible hindsight” (in Remarks, at least on page 3 last paragraph and page 4 first paragraph),
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).
Conclusion
22. 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 extension fee 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 date of this final action.
Any inquiry concerning the communication or earlier communications from the examiner should be directed to Bhaskar Mukhopadhyay whose telephone number is (571)-270-1139.
If attempts to reach the examiner by telephone are unsuccessful, examiner’s supervisor Erik Kashnikow, can be reached on 571-270-3475. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BHASKAR MUKHOPADHYAY/
Examiner, Art Unit 1792
/ERIK KASHNIKOW/Supervisory Patent Examiner, Art Unit 1792