DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim status
The examiner acknowledged the claims filed 09/15/2025.
Claims 1, 6, 8-17, 19-23, 25, 28 and 31 are pending in the application. Claims 1, 6, 8-9, 17, 19-23, 25, 28 and 31 are previously presented. Claims 2-5, 7, 18, 24, 26-27 and 29-30 are previously cancelled. Claims 10-16 remain withdrawn as being drawn to a nonelected invention (election was made without traverse in the reply filed 01/26/2016). Claims 1, 6, 8-9, 17, 19-23, 25, 28 and 31 are hereby examined on the merits.
Examiner Note
Any objections and/or rejections that are made in the previous actions and are not repeated below, are hereby withdrawn.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 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, 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.
Claims 1, 6, 8-9, 17, 20-22, 25, and 31 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Nissen US Patent No. 6,291,525 (hereinafter referred to as Nissen) in view of DeWille US Patent Application Publication No. 2011/0305799 A1 (hereinafter referred to as DeWille) and Cirigliano US Patent No. 6,022,576 (hereinafter referred to as Cirigliano).
Regarding claims 1, 6, 8, 22 and 31, Nissen teaches a liquid composition (e.g., liquid drink such as water, coffee, tea, sports drink, orange drink or complete nutritional drink, etc.) comprising HMB free acid, or salt thereof for improving a human’s perception of his emotional state (column 2, line 59-60 and column 4, line 5-20; column 1, line 55-58). HMB free acid is a liquid in ambient temperature thus reading on the limitation that the HMB free acid in a liquid from.
Nissen does not teach that the liquid composition comprises 0.5-3 grams of HMB acid. However, Nissen teaches that any suitable dose of HMB so as to improve a human’s perception of his emotional state, can be used, and with respect to calcium salt of HMB to administer, the dose is 5-300 gm per kg of body weight per 24 hours (column 3, line 35-55). It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have optimized the amount of HMB in the composition such that it could effectively improve a human’s perception of his emotional state. As such, the amount of HMB as recited in claim 1 is merely an obvious variant of the prior art.
Nissen is silent regarding the liquid composition comprising soluble protein such as those listed in claim 31 and vitamin.
In the same field of endeavor, DeWille teaches a nutritional liquid drink that is shelf stable comprising a source of HMB such as calcium HMB or HMB free acid, soluble protein such as whey protein concentrate, whey protein isolate, casein hydrolysate and hydrolyzed collagen, and at least one vitamin ( [0014; 0016; 0038; 0035; 0042; 0012; 0064; 0067]).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified Nissen by including a soluble protein such whey protein concentrate, whey protein isolate and casein hydrolysate, and a vitamin with reasonable expectation of success, since prior art has established that it is suitable to add soluble protein and vitamin to a nutritional drink that comprises HMB to provide extra nutrients.
Nissen in view of DeWille results in a composition comprising whey protein concentrate, whey protein isolate or casein hydrolysate all of which are known to be soluble protein, thus reading on the limitations that the composition is free of hydrolyzed collagen.
Nissen as recited above includes the embodiment teaching HMB in free acid form thus not requiring calcium HMB; further, Nissen does not require the presence of any other ingredients such as calcium, or fat in the composition (column 2, line 59-60 and column 4, line 5-20; column 1, line 55-58), which is interpreted to read on the limitations that the composition is free of calcium, is non-emulsified type, and that the composition has a fat content of less than 1% by weight as recited in claims 1 and 22.
Nissen is silent regarding the pH of the liquid composition being 2-4.7 or 2-2.8 as recited in claim 1 and 8.
DeWille teaches that a nutritional liquid drink that comprises HMB free acid, a vitamin and a soluble protein can have a pH of about 2.8-4.6 ( [0014; 0038; 0012; 0067]).
Cirigliano teaches that lower pH such as 2.8-3.1 contributes to the microbial stability of a beverage (column 9, line 15-16; column 10, line 15; Table 9 and Table 10).
Both Nissen and DeWille are directed to nutritional drink comprising HMB, Both Nissen and Cirigliano are directed to beverages. Further, where DeWille teaches a beverage having an acidic pH, Cirigliano teaches that lower pH contributes the microbial stability of a beverage. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified Nissen by including the pH as disclosed by DeWille with reasonable expectation of success, for the reason that prior art has established that it is suitable to adjust the pH of a nutritional liquid drink that comprises HMB free acid, a vitamin and a soluble protein to a range of 2.8-4.6, and a lower pH contributes to the microbial stability of a beverage.
The pH as disclosed by DeWille falls within or overlaps with the pH ranges as recited in claim 1 and claim 8. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. (MPEP 2144.05 I).
Nissen as modified by DeWille and Cirigliano arrives at the composition as claimed it thus logically follows that the prior art composition has the stability property as claimed. See In re Best. Of note is that the claim does not recite the volume of the liquid composition.
Regarding Claim 9, Nissen as modified by DeWille teaches that the nutritional liquid has a pH of about 2.8-4.6 ([0014; 0031]), the lower endpoint of which is very close to the upper endpoint of the pH as recited in the claim (note that DeWille teaches a lower endcap of about 2.8, which allows a value that is slightly below 2.8, and claim 9 recites an upper endpoint of “about 2.75”, which allows a value that is slightly above 2.75) that a skilled artisan would have expected them to have the same properties, considering that both DeWille and the claimed invention are directed to liquid compositions that comprise HMB free acid, soluble protein and/or vitamin. It has been held that a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (MPEP 2144.05).
Regarding claim 17, Nissen in view of DeWille and Cirigliano as enumerated above, teaches a liquid composition containing HMB acid, soluble protein and vitamin which is essentially identical with the claimed liquid composition, it thus logically follows that the liquid composition of Nissen in view of DeWille possesses the property of not imparting a change in flavor or metallic after-taste to the liquid composition (note that Table 4 of the instant specification recites that adding HMB free acid as opposed to HMB salt to a beverage does not change flavor and does not impart a metallic after-taste).
Regarding claim 20, Nissen in view of DeWille and Cirigliano does not teach the volume of the drink. However, it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have selected any serving size such that the drink could effectively improve a human’s perception of his emotional state . As such the volume as recited in the claim is merely an obvious variant of the prior art.
Further, DeWille teaches a serving size of 100-591 ml (0032). It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified Nissen by including the serving size as disclosed by Wille with reasonable expectation of success, for the reason that prior art establishes that a nutritional drink containing HMB can have a serving seize of 100-591 ml.
Regarding claim 21, as recited above, Nissen as modified by DeWille results in a composition comprising whey protein concentrate, whey protein isolate or casein hydrolysate all of which are known to be soluble protein, thus reading on the limitation that the soluble protein is the primary source of protein as recited in claims 21.
Regarding claim 25, DeWille teaches that the total protein (e.g., soluble and insoluble) is 3-5% ([0055]), which is roughly about 30-50 g/L (assuming a density of 1 g/ml). It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified Nissen by incorporating the amount of soluble protein as disclosed by DeWille with reasonable expectation of success, for the reason that prior art has established that such an amount of soluble protein is suitable in a drink that comprises HMB.
Claims 19, 23 and 28 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over DeWille (US 2011/0305799 A1) in view of Rathmacher, Fuller, Baier, Nissen, and Abumard US Patent Application Publication No. 2010/0179112 A1 (cite in the IDS filed 08/13/2014, hereinafter referred to as Fuller).
Regarding claims 19, 23 and 28, DeWille teaches a substantially clear, non-emulsified liquid composition (e.g., nutritional liquid) that is shelf stable comprising a source of HMB such as calcium HMB or HMB free acid, soluble protein and at least one vitamin such as vitamin D ( [0014; 0016; 0038; 0035; 0012; 0064; 0067]). DeWille teaches that the liquid composition has a fat content of less than 1% by weight ([0027]). DeWille teaches that nutritional liquid has a pH of 2.8-4.6 ([0014; 0031]). HMB free acid is a liquid in ambient temperature thus reading on the limitation that the HMB free acid in a liquid from.
DeWille teaches that if calcium HMB is used as the source of HMB, the nutritional liquid comprises 0.5-3 gram of calcium HMB per 240 ml nutritional liquid ([0036]). DeWille is silent regarding the amount of HMB free acid in the nutritional liquid in the case where HMB free acid is used. However, the amount of HMB free acid in the composition depends on, inter alia, the serving size of the nutritional liquid. In the instant case, DeWille teaches a typical serving size ranges from 100-591 ml ([0032]). DeWille also teaches that HMB supplementation increased lean mass (0006); clinical studies also suggest that HMB has at least two functions in recovery from illness or injury including protection of lean mass from stress-related damage and enhancement of protein synthesis (0006); it has been suggested that HMB may also be useful in enhancing immune function, reducing the incidence or severity of allergy or asthma, reducing total serum cholesterol and low density lipoprotein cholesterol, increasing the aerobic capacity of muscle, etc. It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have optimized the concentration of HMB in a specific serving of the nutritional liquid such that it could suitably deliver the aforementioned health benefits. As such, the amount of HMB as recited in claim 19 are merely obvious variant of the prior art.
DeWille teaches that the soluble protein may represent from 65-100% by weight of the total protein in the liquid composition ([0038]), and that the soluble protein comprises whey protein concentrate, whey protein isolate, casein hydrolysate, hydrolyzed collagen or combination thereof ([0042]), thus reading on the limitation that the liquid composition is free of hydrolyzed collagen since DeWille lists hydrolyzed collagen and other proteins and does not require that hydrolyzed collagen has to be there.
Regarding the limitation that the liquid composition comprises a soluble salt selected from the group consisting of calcium carbonate, calcium citrate, calcium gluconate, calcium lactate, calcium phosphate, and calcium panthothenate, 0033 of DeWille teaches that the liquid composition comprises calcium, and 0051 of DeWille teaches that a calcium source other than Ca-HMB is suitable; further, 0071 of DeWille teaches that citric acid or phosphoric acid is included in making the liquid composition for adjust pH, therefore, the final liquid composition reasonably includes calcium phosphate or calcium citrate.
DeWille teaches that the nutritional liquid comprises a vitamin, for example, vitamin D at a concentration that is up to about 1000 IU (0012). The higher bound “about 1000 IU” as disclosed by DeWille is very close to an amount that is slightly greater than 1000 IU as encompassed by the range of greater than 1000 IU in claim 19 that one of ordinary skill in the art would expect they have same property, given that both the claimed invention and DeWille are directed to liquid composition comprising HMB, a protein and vitamin D. It has been held that a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (MPEP 2144.05).
Further, Fuller in the same field of endeavor teaches an enteral liquid composition for increasing muscle mass, strength and functionality (0028), the composition comprising HMB in free acid form and a vitamin such as vitamin D (0028; 0042; 0041), wherein a synergism exists between HMB and vitamin for improving muscle strength and function (0068) and wherein the amount of Vitamin D in the composition can be selecting an amount of Vitamin D within the range of greater than 500IU, as the below examples indicate that 500IU is the lower threshold for an effective amount in individuals with inadequate levels of Vitamin D in their bloodstream, yet not too much Vitamin D as to be toxic. For example, vitamin D in the composition can be 1000-4000 IU (0050-0051).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified DeWille by including vitamin D at an amount of 1000-4000 IU with reasonable expectation of success, for the reason that prior art has established such an amount is suitable to be present in a liquid composition that comprises HMB and Vitamin D for improving muscle function.
DeWille as modified by Fuller arrives at the composition as claimed it thus logically follows that the prior art composition has the stability property as claimed. See In re Best. Of note is that the claim does not recite the volume of the liquid composition.
Response to Arguments
Applicant's arguments filed 09/15/2025 have been fully considered but were found not be persuasive.
Applicant argues on page 7 of the Remarks that claim 1 is not obvious over Nissan in view of DeWille and Cirigliano, for the reason that in all embodiments listed in DeWille where vitamin D is included with HMB, the HMB is listed as ca-HMB. Applicant further argues on page 8 of the Remarks that claim 19 is not obvious over DeWille in view of Fuller, for the reason set forth above (e.g., DeWille only teaches the combination of Ca-HMB and vitamin D), and that Fuller does not includes the examples comprising HMB free acid and vitamin.
The argument is considered but found unpersuasive. Applicant is relying on prior art reference’s exemplary embodiments to narrow prior art’s effective disclosure. In an obviousness inquiry, all disclosures of the prior art, including unpreferred embodiments, must be considered. Merck & Co.v. Biocraft Labs., Inc.,874 F.2d 804, 807 (Fed. Cir. 1989) (citing In re Lamberti, 545 F.2d 747, 750, 192 USPQ 278,280 (CCPA 1976)). In the instant case, where para. [0035] of DeWille teaches that the suitable source of HMB in the substantial clear nutritional liquid includes HMB free acid and para. [0064] teaches including vitamin D in the substantial clear nutritional liquid, DeWille encompasses the embodiment teaching a substantial clear nutritional liquid comprising HMB free acid and vitamin D. Similarly, Fuller para. [0042] teaches HMB free acid and para. [0040; 0044] teaches vitamin D thus Fuller includes the embodiment teaching the combination of HMB free acid and vitamin D. To this end, “applicant must look to the whole reference for what it teaches. Applicant cannot merely rely on the examples and argue that the reference did not teach others.” In re Courtright, 377 F.2d 647, 153 USPQ 735,739 (CCPA 1967).
On the other hand, the examiner notes that the arts as cited has not shown otherwise, e.g., that the combination of HMB free acid and vitamin D will wreck the nutritional composition. Nor has the applicant.
For the reasons set forth above, applicant’s arguments regarding depending claims 6, 8-9, 17, 20-23, 25, 28 and 31 are not persuasive.
Conclusion
THIS ACTION IS MADE FINAL. 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 CHANGQING LI whose telephone number is (571)272-2334. The examiner can normally be reached 9:00-5:00.
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, NIKKI H DEES can be reached at 571-270-3435. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CHANGQING LI/Primary Examiner, Art Unit 1791