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 .
Response to Amendment
Applicant's amendment and argument filed 05/21/2026 are acknowledged and have been fully considered. Any previous rejection or objection not mentioned herein is withdrawn.
Claims 1-7, 10, 12, 25 and 29-30 are pending and being examined on the merits.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05/22/2026 is being considered by the examiner. The signed IDS form is attached with the instant office action.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-7, 10,12, 25 and 29-30 are rejected under 35 U.S.C. 103 as being unpatentable over Pouteau et. al. (WO2013057229A1) and Mignone et. al. (Whey Protein: The “whey” forward for treatment of type 2 diabetes, World J Diabetes, 2015 Oct 25;6(10:1274-1284) and Christophe Schmitt et. al. (US10251913B2, US equivalent to JP2018502052, from IDS filed on 05/22/2026). This rejection is maintained with a new reference as additional evidence, due to the amendments filed on 05/21/2026.
Pouteau’s general disclosure is to the use of whey protein micelles for increasing satiety and/or postprandial energy expenditure (see abstract).
Regarding claims 1-4, Pouteau teaches whey protein micelles (WMP) for preventing and treating of overweight and/or obesity in a subject wherein the WPM are administered in combination with a meal (see claim 1). Pouteau teaches that it is known that the benefits of whey protein are for control of blood glucose and weight management satiety (see page 5, lines 5-8).
Regarding claim 5, Pouteau teaches the composition is a liquid (see page 5, lines 4-5).
Regarding claim 7, Pouteau teaches the composition to further comprise 15-30 wt % proteins, 10-15 wt % lipids, 35-50 wt % carbohydrates and 5-10 wt % fibers (see claim 12, page 15).
Regarding claims 10, pertaining to the wherein the meal is administered thirty minutes after the administration of the composition comprising WMP, these all would have been obvious given the knowledge of people skilled in the art and given the prior art. Pouteau teaches the same WMPs for administration for the same patient population and although Pouteau teaches administration with the meal and the instant applicant teaches about 30 mins. before the meal, it would be expected to have the same effects, even when the meal is breakfast as instantly claimed. It would have been obvious to first eat a meal and then subsequently eat the WMPs because people may not want to mix whey protein micelles in with their food as it would change the flavor and may not mix well with other food items being consumed.
Regarding claim 12, pertaining to the limitation wherein the individual does not consume any food products other than water during a time period from the oral administration of the composition to the oral administration of the meal, this limitation would have been obvious to persons skilled in the art because some nutrients are known to bind with the medicines ingredients and can affect the way the medicine is metabolized.
Pouteau does not specifically teach wherein the individual has type-1 diabetes, type-2 diabetes, gestational diabetes mellitus, diabetes or pre-diabetes, or wherein the composition is administered to the individual in a serving comprising from about 5 g to about 15 g of the WPM and administering a meal about 30 mins after the orally administering of the composition comprising the WPM.
Mignone’s general disclosure is a report on whey protein for treatment of type-2 diabetes (see abstract).
Mignone teaches “Whey protein, a by-product of the cheese-making process, can be used to manipulate gut function in order to slow gastric emptying and stimulate incretin hormone secretion, thereby attenuating postprandial glycaemic excursions. The function of the gastrointestinal tract plays a pivotal role in glucose homeostasis, particularly during the postprandial period, and this review will discuss the mechanisms by which whey protein slows gastric emptying and stimulates release of gut peptides, including the incretins. Whey protein is also a rich source of amino acids, and these can directly stimulate beta cells to secrete insulin, which contributes to the reduction in postprandial glycaemia. Appetite is suppressed with consumption of whey, due to its effects on the gut-brain axis and the hypothalamus. These properties of whey protein suggest its potential in the management of type 2 diabetes.” (see abstract).
Mignone teaches “whey can slow gastric emptying, stimulate insulin and gut hormones including the incretins, and thereby reduce postprandial blood glucose, especially when consumed some minutes before a meal. Whey may also suppress appetite and reduce food intake” (see page 1274, bottom right las para.).
Regarding claims 1, 3, 6 and 25, pertaining the amount of WPM, Mignone teaches “Gunnerud et al found that a drink containing 25 g glucose and either 4.5 g, 9 g or 18 g whey protein, reduced postprandial glycaemia (iAUC) by 25%, 37% and 46% respectively, compared to a 25 g glucose alone; the reductions with 9 g and 18 g whey were statistically significant. There was also a dose dependent increase in insulin (iAUC 0 – 120 min), which reached statistical significance with the highest dose of whey” (see page 1279, right column, 2nd para.).
Schmitt teaches “the composition for use according to the invention may be administered in a daily dose to provide between 0.10 g and 0.75 g dry weight of whey protein micelles per 1 kg body weight,” (see column 7, lines 13-15).
Schmitt teaches wherein postprandial glucose is reduced relative to another postprandial glucose on oral administration of a composition comprising the same amount of whey protein in a form of whey protein isolate being administered at the same amount of time before a meal (see results of figure 7 or column 12, lines 50-60)).
Therefore it would have been obvious to persons skilled in the art to use the composition taught by Pouteau for diabetes patients because Mignone teaches properties of whey protein suggest its potential in the management of type 2 diabetes and so using whey protein micelles for the same management would have been obvious to persons skilled in the art. For instance, Mignone teaches wherein consuming only amounts of 9 g whey protein, reduced postprandial glycemia by 37% which was a significant difference when compared to controls. Additionally, Schmitt teaches administering amounts of whey protein micelles at 0.10 g and 0.75 g dry weight of whey protein micelles per 1 kg body weight. When considered and using the lesser side of this equation, a 100-150lb person would consume 0.10g x 68.04kg-81.65kg (150-180lbs) which would equate to 6.8-8.2 grams of whey protein micelles. This is within the 5-15 grams being claimed. Also, Schmitt teaches wherein the post prandial glucose is reduced relative to another oral administration of a whey protein isolate in the same amount and at the same time before a meal.
It would have been obvious to first consume the WMPs and then eat a meal because people may not want to mix whey protein micelles in with their food as it would change the flavor and may not mix well with other food items being consumed. Also, Mignone teaches that it is beneficial to consume whey protein some minutes before a meal to suppress appetite and food intake along with slowing of gastric emptying and stimulating insulin and gut hormones. Given this information it would have been prima facie obvious to optimize the time to about 30 minutes before a meal as instantly claimed.
It would have also been obvious to optimize the amount of serving of WPMs to be within the instantly claimed amounts because the art makes obvious to administer these amounts within these ranges and it is obvious to do so depending on the specific outcome and patient population. Administering these WMPs to different patient populations such as obese patients and type-2 diabetes patients would require optimizing the amount for arriving at the most effective outcome. This is a component any person skilled in the art could manage without any undue experimentation. Both the whey protein micelles and the time in which to administer the WPM before a meal are recognized as a known result-effective variable. Each result-effective variable are optimizable parameters and would have been prima facie obvious to optimize to those having ordinary skill in the art given the relied upon prior art.
Regarding new claims 29-30, pertaining to where the meal comprises WPM in amounts that are completely free of WPMs, this limitation would have been obvious as persons having skill in the art would not continue adding them to a meal especially if they had just been administered the composition comprising the WMPs.
There would have been a reasonable expectation of success in arriving at the instant invention because WMPs have already been known in the art for controlling blood glucose levels and the administration to patients who are overweight and administering the composition 30 minutes before eating a meal are obvious components given the prior art and knowledge of an artisan.
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 1-6, 10-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 8-10 of U.S. Patent No. 10,028,978 in view of Mignone (secondary reference relied upon in the above rejections). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are directed to the compositions comprising of the same components (WMPs) which would ultimately have the same effect of reducing glucose levels. U.S. Patent No. US10028978 claims teach different amounts of the WMPs to be administered, but those do not distinguish the inventions from each other given that they are both comprising the same ingredients (WMPs) given to the same patient population (and overlapping patient populations) for reducing glucose levels.
For instance, claim 2 of the copending patent directs the treatment to the same patient population as the instant invention (type-2 diabetics) and so a mere modifying of the amount of micelles to consume would be a matter of optimization especially if the amounts are overlapping. The instant claims 1, 3, 6 and 25 recite about 5g to 15g of the WPMs and 10 g WPMs and the copending patent recites 1.4 to 3.8 g per 100 kcal. These amounts when considered indeed overlap and along with being given to the same patient population would render the inventions to be not patentably distinct.
Given the prior art from Mignone: “Whey can slow gastric emptying, stimulate insulin and gut hormones including the incretins, and thereby reduce postprandial blood glucose, especially when consumed some minutes before a meal. Whey may also suppress appetite and reduce food intake” (see page 1274, bottom right last para.). It would have been obvious to persons having ordinary skill in the art to administer the WPMs about some ten minutes before a meal for the reasons just described.
Response to Arguments
Applicant's arguments filed 05/21/2026 have been fully considered but they are not persuasive. The applicant arguments have not changed. The applicant argues that Pouteau teaches administering WPM at 20 g and that Mignone teaches administration of whey protein (isolate, concentrate or hydrolysate) some minutes before a meal and that optimal results for reducing post prandial glucose are noted at 18 g whey protein being administered, thus a skilled person would not be motivated to administer the WPM in the claimed range of 5-15 g. A person having ordinary skill would also note that Mignone teaches post prandial glucose is lowered with 9 grams of whey protein being administered. This is within the taught range. Additionally, one would rely on Schmitt and see that their art teaches adding WMPs at 0.1 g pers kg of body weight. A 150-180 lb (68.04 kg-81.65 kg) person would need 6.8-8.2 g or WMPs which is also within the amount claimed. A person having ordinary skill in the art would be motivated to optimize to the effective amount taught by Schmitt.
The applicant argues that Mignone teaches only of whey protein isolate, concentrate, or hydrolysate but this is not true as Mignone also teaches of the benefits of whey protein in general.
The applicant argues that the Office cherry picks data from specific aspects of each disclosure to make an obvious style rejection. Any person having ordinary skill in the art would rely on these pieces of art and would easily see that the time of administration and the active component being administered are indeed optimizable pararmeters. Mignone teaches that 9 g of whey protein components was enough to reduced postprandial glycaemia (iAUC) by 37%. Also, Shcmitt teaches amounts of WMPs that are within the disclosed range as just argued. Mignone also teaches to consume whey protein some minutes before a meal to suppress appetite and food intake along with slowing of gastric emptying and stimulating insulin and gut hormones. Mignone therefore teaches that both timing of administration before a meal and the amount of whey consumed are results-effective variables which are optimizable parameters to those having ordinary skill in the art. Additionally, Pouteau teaches administering 20 g of WPMs, which when considered with the broadest reasonable interpretation can be “about” 15 g., as these are close in range and the applicant does not define what the term “about” would equate to. Given the prior art the instant optimizations are prima facie obvious. As discussed in the MPEP 2141.02, V: “Note, however, that after KSR, the presence of a known result-effective variable would be one, but not necessarily the only, motivation for a person of ordinary skill in the art to experiment to reach another workable product or process. See MPEP § 2144.05, subsection II.B. See also In re Papesch, 315 F.2d 381, 391, 137 USPQ 43, 51 (CCPA 1963)”. In this case both the active component which are the whey protein micelles and the timing of administration before a meal would have been considered a result-effective variable especially given the prior art.
Optimizing both the time of administration and the amount of the WMPs which are the effective active ingredients to the ranges claimed is prima facie obvious given the prior art and the knowledge of any artisan having ordinary skill in the art.
The applicant argues that the applicant gives a direct comparison of WMPs to that of whey protein isolate and shows that WPMs out perform the isolate. The art already recognizes that WPMs out perform whey isolate as can be recognized by Schmitt.
Conclusion
Currently no claims are 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 JACOB ANDREW BOECKELMAN whose telephone number is (571)272-0043. The examiner can normally be reached Monday-Friday 8am-5pm.
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JACOB A BOECKELMANExaminer, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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