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 .
Priority
The instant application is a U.S. National Phase of PCT/EP2016/074081, filed on 10/7/2016, and claims foreign priority to EP15188842.7, filed 10/7/2015.
DETAILED ACTION
Applicant’s amendments filed on 10/13/2025 and 10/14/2025 are acknowledged. The claim set filed on 10/13/2025 improperly marked micrometers with an underline in claim 24, which had been previously amended in the claims submitted 9/19/2023. The claim set did correctly identify claim 24 as previously presented, but the underline was still present. Subsequently, the claim set filed on 10/14/2025 removed the underline.
Claims 1, 19, 22, 30, and 32 are currently amended. Claims 38-41 are newly added. Claims 2-18, 20-21, and 31 have been canceled.
Claims 1, 19, 22-30, and 32-41 are pending in the instant application.
Claims 28-29 and 34-35 remain withdrawn pursuant to 37 CFR 1.142(b) as being drawn to a non-elected invention.
Claims 1, 19, 22-27, 30, 32-33, and 36-41 are examined in this office action.
The 35 U.S.C. § 112(b) rejection of claim 30 previously set forth in the Non-Final Rejection mailed on 4/14/2025 is withdrawn due to deletion of the term “microorganism” and addition of “live probiotic bacterium” in claim 30.
The 35 U.S.C. § 102(a)(1) rejection previously set forth in the Non-Final Rejection mailed on 4/14/2025 is withdrawn due to amendment in claim 1.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 9/18/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 1 is objected to because of the following informalities:
The “and” recited at the end of element (iii) should be replaced with a comma, since element (iii) is not directly before the last element recited in the claim, i.e., element (vi). Appropriate correction is required.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
New Rejection Necessitated by Amendment: Claims 1, 23, 25-27, and 38-41 are rejected under 35 U.S.C. 103 as being unpatentable over Barry et al. (AU2014100089; of record) in view of He et al. (Circulation, 2006, Vol. 113(13), p.1675-1682; of record) and as evidenced by “The Storm” YouTube Channel Video Entitled “2 lb. container of dry protein powder Challenge” (published on Feb. 6, 2015; < https://www.youtube.com/watch?v=6ST1ZVap0u8>).
Regarding claims 1 and 25-27, Barry teaches the compositions of their disclosure are useful for managing diseases and/or disorders that are associated with excessive calorie intake, such as obesity, metabolic syndrome, and diseases and conditions related thereto (see p.6, 5th passage). Barry discloses an oral powder composition that comprises the probiotics Lactobacillus acidophilus LA14 and Bifidobacterium lactis BL-04, magnesium oxide, the low calorie/bulk sweetener xylitol, and vanilla and cream flavors (see Example 1). Barry teaches a 1.25% w/w (12.555 g/1001.159 g) of magnesium oxide mineral in the powder composition disclosed in example 1. The instant specification discloses on p.5, lines 15-23, that flavors are one group of aroma compounds that affect both the sense of taste and smell, and thus the vanilla and cream flavors of the oral powder composition of Barry are aroma compounds. The oral powder composition also comprises the vitamins A, C, and E, which are considered to be antioxidants as disclosed in the specification on p.6, lines 1-6.
Barry does not teach a mass concentration of 4 to 8 % w/w, or 4 to 7 % w/w, as recited in claims 1 and 23, respectively, for magnesium oxide.
He teaches magnesium intake is inversely associated with incidence of metabolic syndrome in a dose responsive manner (see Abstract, p.1675, right column, 1st paragraph, and paragraph bridging p.1677 and p.1678).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have routinely optimized the magnesium oxide content in the oral powder composition of Barry to provide an increased concentration of magnesium oxide and arrive at a concentration within the ranges recited in claims 1 and 23. One of ordinary skill in the art would have been motivated to provide an optimal dosing of magnesium minerals to provide an optimized composition useful for managing metabolic syndrome.
Regarding claim 38, Barry further teaches the oral powder composition is typically dissolved in water or other liquid to be taken once to three times daily (see Example 1 – p.15, last passage). This implies that the oral powder composition disclosed in Example 1 does not necessarily need to be dissolved in liquid for consumption. In fact, The Storm’s YouTube video provides evidence that dry protein powder can be eaten directly without reconstitution in liquid. Therefore, the oral powder composition of Barry reads on wherein the composition is formulated for oral ingestion in powder form, as claimed.
Regarding claim 39, Barry teaches the oral powder composition of Example 1 comprises 10.14% of the low calorie/bulk sweetener xylitol (101.563 g xylitol/1001.159 g total).
Barry does not teach a concentration of 70 to 95 % w/w of at least one low calorie sweetener.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have increased the concentration of xylitol in the oral powder composition of Barry through routine optimization and arrive at a concentration within the claimed range. The person of ordinary skill in the art would have been motivated to increase the sweetness of the oral powder composition, yielding predictable results.
Regarding claim 40, Barry teaches the oral powder composition of Example 1 comprises 10.14% of the low calorie/bulk sweetener xylitol (101.563 g xylitol/1001.159 g total). Barry further teaches their compositions include at least one sugar alcohol that functions as a sweetener and teaches the sweetener erythritol (see p.9, 5th passage).
Barry does not teach the at least one low calorie sweetener is a mixture of erythritol and xylitol.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have further included erythritol sweetener in the oral composition taught by Barry, to arrive at the claimed invention. One of ordinary skill in the art would have been motivated to increase the sweetness of the oral powder composition and Barry suggests more than one sweetener, such as erythritol, can be included in their compositions, yielding predictable results.
Regarding claim 41, Barry teaches the oral powder composition of Example 1 comprises 10.14% of the low calorie/bulk sweetener xylitol (101.563 g xylitol/1001.159 g total). Barry further teaches their compositions include at least one sugar alcohol that functions as a sweetener and teaches the sweetener erythritol (see p.9, 5th passage).
Barry does not teach the at least one low calorie sweetener is a mixture of erythritol and xylitol at 70 to 95 % w/w.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have further included erythritol sweetener in the oral composition taught by Barry and to have increased the concentration of xylitol and erythritol through routine optimization to arrive at a concentration within the claimed range. One of ordinary skill in the art would have been motivated to increase the sweetness of the oral powder composition and Barry suggests more than one sweetener, such as erythritol, can be included in their compositions, yielding predictable results.
Thus, claims 1, 23, 25-27, and 38-41 are prima facie obvious over Barry in view of He.
New Rejection Necessitated by Amendment: Claims 19 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Barry et al. (AU2014100089; of record) in view of He et al. (Circulation, 2006, Vol. 113(13), p.1675-1682; of record), as applied to claims 1, 23, 25-27, and 38-41 above, and further in view of Lipasek et al. (J. Food Sci., 2011, Vol. 76(7), p.C1062-C1074; of record).
Barry in view of He teach the invention of claim 1 as outlined in the rejection above.
Regarding claims 19 and 22, Barry and He do not teach silicon dioxide in the oral powder composition.
Lipasek teaches anticaking agents are often added to powder systems to delay or prevent caking (see Abstract and paragraph bridging p.C1062-C1063). Lipasek teaches the anticaking agents calcium phosphate, calcium silicate, calcium stearate, corn starch, and silicon dioxide (see Abstract, Tables 1-3, and Figs. 1-5).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have further included silicon dioxide as an anticaking agent in powder formulations, as taught by Lipasek, in the oral powder composition of Barry as modified by He, to arrive at the claimed invention. One of ordinary skill in the art would have been selecting an anticaking agent from a finite list of anticaking agents disclosed by Lipasek. One of ordinary skill in the art would have been motivated to include the silicon dioxide anticaking agent in the oral powder composition of Barry in order to delay or prevent caking of the powder composition, yielding predictable results.
Thus, claims 19 and 22 are prima facie obvious over Barry in view of He and Lipasek.
New Rejection Necessitated by Amendment: Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Barry et al. (AU2014100089; of record) in view of He et al. (Circulation, 2006, Vol. 113(13), p.1675-1682; of record), as applied to claims 1, 23, 25-27, and 38-41 above, and further in view of Onwulata et al. (J. Dairy Sci., 2004, Vol. 87(3), p.749-756; of record).
Barry in view of He teach the invention of claim 1 as outlined in the rejection above.
Regarding claim 24, Barry teaches the oral powder composition comprises 56.18% whey protein concentrate powder (562.50 g whey protein concentrate/1001.159 g total weight) in the composition disclosed in example 1. Barry further teaches the oral powder composition is typically dissolved in water or other liquid to be taken once to three times daily (see Example 1).
Barry and He do not teach wherein 35 to 95% of the particles of the powder composition have a particle size not larger than 200 micrometers.
Onwulata teaches that sieving whey protein concentrate products within the particle size distribution range of 100 to 150 microns minimized variation in physical composition and making functionality uniform with regards to solubility (see Abstract and p.753, paragraph bridging left and right columns, Table 3 and Fig. 5).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to sieve the whey protein concentrate in the oral powder composition of Barry within a particle size distribution range of 100 to 150 microns, as taught by Onwulata, to arrive at the claimed invention. One of ordinary skill in the art would have been motivated to minimize variation in physical composition and to make uniform the solubility of the powder, yielding predictable results. One of ordinary skill in the art would have been motivated to have the particle size distribution range within 100 and 150 microns because Barry teaches the oral powder composition is mixed with water or another liquid.
The proposed modification would yield the oral powder composition of Barry having whey protein concentrate at between 100 and 150 microns, which makes up 56.18% of the powder composition. Therefore, claim 24 is prima facie obvious.
New Rejection Necessitated by Amendment: Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Barry et al. (AU2014100089; of record) in view of He et al. (Circulation, 2006, Vol. 113(13), p.1675-1682; of record), as applied to claims 1, 23, 25-27, and 38-41 above, and further in view of “Dosage” – Probiotic Advisor (Published Mar. 16, 2015 - retrieved from https://www.probioticadvisor.com/probiotic-essentials-2/dosage/; of record).
Barry in view of He teach the invention of claim 1 as outlined in the rejection above.
Regarding claim 30, Barry teaches the oral powder composition comprises 150 billion Lactobacillus acidophilus LA14 per gram and 450 billion Bifidobacterium lactis Bl-04 per gram (see Example 1).
Barry does not teach one dose of the composition comprises 103 to 1012 colony forming units of said microorganism.
Probiotic Advisor teaches that probiotics dosed at between 107-1011 CFU/day in foods and supplements have demonstrated successful results in clinical trials (see p.1, 2nd passage). Probiotic Advisor teaches that it is best practice to ensure that supplements contain bacteria in concentrations over 109 CFU/dose for each strain to ensure effectiveness and achieve therapeutic effects (see p.1, passages 3-4).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have adjusted the concentration of the Lactobacillus acidophilus LA14 and Bifidobacterium lactis Bl-04 to a dose between 107-1011 CFU, as taught by Probiotic Advisor, to arrive at the claimed invention. One of ordinary skill in the art would have been motivated to provide clinically effective doses of the probiotics in the oral powder composition of Barry to ensure best practices and effectively achieve therapeutic effects, yielding predictable results.
New Rejection Necessitated by Amendment: Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over Barry et al. (AU2014100089; of record) in view of He et al. (Circulation, 2006, Vol. 113(13), p.1675-1682; of record), as applied to claims 1, 23, 25-27, and 38-41 above, and further in view of Kim et al. (Biochem. Biophys. Res. Comm., 2013, Vol. 431, p.258-263; of record) and Abdulmumeen et al. (Int. J. Chem. Biochem. Sci., 2012, Vol. 1, p.36-47; of record).
Barry in view of He teach the invention of claim 1 as outlined in the rejection above.
Regarding claim 32, Barry teaches weight loss and/or fat loss compositions and discloses an oral powder composition that comprises the probiotics Lactobacillus acidophilus LA14 and Bifidobacterium lactis Bl-04 at a total of 0.05% w/w ((0.469 g L. acidophilus LA14 + 0.052 g B. lactis Bl-04)/1001.159 g total), magnesium oxide, 10.14% of the low calorie/bulk sweetener xylitol (101.563 g xylitol/1001.159 g total), the flavored aroma compounds vanilla and cream at a total of 2.58% w/w ((12.35 g vanilla flavor + 13.547 g cream flavor)/1001.159 g total), and the antioxidants vitamins A, C, and E, as discussed in the rejection of claim 1 above (see Example 1). Barry further teaches the probiotic microorganism may be one or more Lactobacillus species including Lactobacillus rhamnosus (see p.8, 2nd-3rd passages). Barry further teaches their compositions include at least one sugar alcohol that functions as a sweetener and teaches the sweetener erythritol (see p.9, 5th passage).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have further included erythritol in the oral powder composition of Barry. One of ordinary skill in the art would have been motivated to make the oral powder composition sweeter and Barry teaches their compositions can comprise at least one sugar alcohol sweetener, yielding predictable results.
Barry and He do not teach Lactobacillus rhamnosus GG, citric acid, or the amounts of components (i)-(ii) and (iv) recited in claim 32.
Kim teaches Lactobacillus rhamnosus GG has shown several beneficial effects such as improved insulin sensitivity and attenuated weight gain in a high fat diet group of mice treated with L. rhamnosus GG (see Abstract, p.259, right column, 2nd paragraph, and Fig. 1).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have substituted Lactobacillus rhamnosus GG, as taught by Kim, for the Lactobacillus acidophilus LA14 in the oral powder composition of Barry, to arrive at the claimed invention. One of ordinary skill in the art would have been motivated to because Barry teaches their compositions are for weight loss and/or fat loss and Kim teaches L. rhamnosus GG is beneficial for weight attenuation, yielding predictable results.
Barry, He and Kim do not teach citric acid, or the amounts of components (i)-(ii) and (iv) recited in claim 32.
Abdulmumeen teaches acid food additives are incorporated into food products to make flavors “sharper” and act as preservatives and antioxidants (see p.43, right column, “10. Classification of food additives; Acids”). Abdulmumeen teaches common food acids include vinegar, citric acid, tartaric acid, malic acid, fumaric acid, and lactic acid.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have further included citric acid food acid additive, as taught by Abdulmumeen, to the oral powder composition of Barry, to arrive at the claimed invention. One of ordinary skill in the art would have been motivated to sharpen the flavor, add antioxidant, and preserve the oral powder composition of Barry and would have been picking from a finite number of food acids disclosed in Abdulmumeen, yielding predictable results.
Barry, He, Kim and Abdulmumeen do not teach the exact amounts of components (i)-(ii) and (iv) as recited in claim 32.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have routinely optimized the amounts of Lactobacillus rhamnosus GG, Bifidobacterium lactis Bl-04, erythritol and xylitol, and citric acid in the oral powder composition as taught by Barry in view of He, Kim, and Abdulmumeen, to arrive at the claimed invention. The person of ordinary skill in the art would have found it obvious to increase an amount of the live probiotic microorganisms to optimize the benefits conferred by the microorganisms. The person of ordinary skill in the art would have found it obvious to increase the amount of the sweeteners erythritol and xylitol to increase the sweetness of the oral composition. The person of ordinary skill in the art would have found it obvious to optimize the amount of citric acid in the composition to provide sharper flavors in the oral composition and provide preservative effects to the oral compositions.
New Rejection Necessitated by Amendment: Claim 33 is rejected under 35 U.S.C. 103 as being unpatentable over Barry et al. (AU2014100089; of record) in view of He et al. (Circulation, 2006, Vol. 113(13), p.1675-1682; of record), as applied to claims 1, 23, 25-27, and 38-41 above, and further in view of Dianawati et al. (Food Res. Internat., 2013, Vol. 50, p.259-265; of record).
Barry in view of He teach the invention of claim 1 as outlined in the rejection above.
Regarding claim 33, Barry and He do not teach wherein the water activity in said composition is in the range of 5% to 10%.
Dianawati teaches freeze dried and spray dried Lactobacillus acidophilus stored in an aluminum foil pouch at room temperature preserved bacterial stability as long as the water activity was maintained at 7 to 10% (see p.264, left column, 1st paragraph).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have maintained the oral powder composition of Barry in view of He at a water activity of between 7 to 10%, to arrive at the claimed invention. One of ordinary skill in the art would have been motivated to preserve the bacterial stability of the powdered L. acidophilus bacteria comprised in the oral powder composition of Barry, yielding predictable results. One of ordinary skill in the art would have had a reasonable expectation of success since the composition of Barry comprises L. acidophilus.
New Rejection Necessitated by Amendment: Claim 36 is rejected under 35 U.S.C. 103 as being unpatentable over Barry et al. (AU2014100089; of record) in view of He et al. (Circulation, 2006, Vol. 113(13), p.1675-1682; of record), Kim et al. (Biochem. Biophys. Res. Comm., 2013, Vol. 431, p.258-263; of record) and Abdulmumeen et al. (Int. J. Chem. Biochem. Sci., 2012, Vol. 1, p.36-47; of record), as applied to claim 32 above, and further in view of Bubbletea Store – Honeydew Powder (https://www.bubbletea.com.au/site/fruit-powder-mix/1000g-foil-pack/honeydew-powder-1kg.html?srsltid=AfmBOopKLDoQeFQWIlsD3Z00TEwxjMWoxSN-hEl9Sgr95rICUP6uSjJn; published 8/20/2015; of record).
Barry in view of He, Kim, and Abdulmumeen teach the invention of claim 32 as outlined in the rejection above.
Barry teaches the oral powder composition comprises the flavored aroma compounds vanilla and cream at a total of 2.58% w/w ((12.35 g vanilla flavor + 13.547 g cream flavor)/1001.159 g total).
Regarding claim 36, Barry, He, Kim, and Abdulmumeen do not teach the at least one aroma compound is honeydew melon aroma.
Bubbletea Store discloses a honeydew powder that provides a sweet melon flavor to food products (see Product Information).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have substituted the honeydew melon powder, as taught by Bubbletea store, for the vanilla and cream flavorings, as taught by Barry, to arrive at the claimed invention. One of ordinary skill in the art would have been motivated to provide an oral powder composition with a different, i.e., honeydew melon flavor, yielding predictable results.
New Rejection Necessitated by Amendment: Claim 37 is rejected under 35 U.S.C. 103 as being unpatentable over Barry et al. (AU2014100089; of record) in view of He et al. (Circulation, 2006, Vol. 113(13), p.1675-1682; of record), Kim et al. (Biochem. Biophys. Res. Comm., 2013, Vol. 431, p.258-263; of record) and Abdulmumeen et al. (Int. J. Chem. Biochem. Sci., 2012, Vol. 1, p.36-47; of record), as applied to claim 32 above, and further in view of Wood (US2013/0202562; Pub. Aug. 8, 2013; of record).
Barry teaches the oral powder composition comprises the flavored aroma compounds vanilla and cream at a total of 2.58% w/w ((12.35 g vanilla flavor + 13.547 g cream flavor)/1001.159 g total). Barry also teaches the oral powder composition comprises Lactobacillus acidophilus LA14 and Bifidobacterium lactis Bl-04 (see Example 1).
Regarding claim 37, Barry, He, Kim, and Abdulmumeen do not teach the at least one aroma compound is eucalyptus aroma.
Wood teaches a microbial composition comprising probiotic microorganisms from the Lactobacillus and Bifidobacterium genera that can be in dry powder form and comprise eucalyptus oil in a range from 1% to 5% of the total weight of the composition (% w/w) (see [0025]-[0026], [0043]-[0044], and [0058]-[0059]). Wood teaches that eucalyptus oil is a natural oil known for its insect repellent characteristics.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have further included eucalyptus oil, as taught by Wood, in the oral powder composition of Barry, to arrive at the claimed invention. One of ordinary skill in the art would have been motivated to do so because Wood teaches eucalyptus oil to be an insect repellent in a powder composition comprising the probiotics Lactobacillus and Bifidobacterium, and they would have had a reasonable expectation of success since the oral powder composition of Barry also contains Lactobacillus and Bifidobacterium.
Response to Arguments
Applicant's arguments filed 10/13/2025 have been fully considered but they are not persuasive.
In Applicant’s Remarks, see p.7, last paragraph, Applicant argues that the “magnesium oxide heavy” comprised in the oral powder composition of Barry is less hygroscopic than the “light” form of magnesium oxide. Applicant further argues Barry mentions that magnesium is a nutrient on page 11, last paragraph. Applicant concludes that Barry does not anticipate a composition comprising magnesium as a hygroscopic agent as recited in claim 1. This is not found persuasive.
Applicant admits that the “magnesium oxide heavy” does still have hygroscopic properties, specifically saying “making [magnesium oxide] easier to blend and less hygroscopic than the “light” form.” Emphasis added. Applicant’s statement demonstrates that magnesium oxide heavy does have hygroscopic properties. MPEP 2112(III) sets forth that where applicant claims a composition in terms of a function, property, or characteristic and the composition disclosed in the prior art does not explicitly disclose the claimed function, rejections may still be made under both 35 U.S.C. 102 and 103. Furthermore, Applicant’s argument with respect to “light” form magnesium oxide are not commensurate in scope with the claimed invention, which does not specifically recite a form of magnesium oxide. Therefore, although Barry does not specifically teach magnesium oxide heavy as a hygroscopic agent, the magnesium oxide heavy in the composition is expected to have hygroscopic properties as indicated by applicant.
In Applicant’s Remarks, see p.8, 2nd paragraph-p.9, 3rd paragraph, Applicant reiterates argument that Barry does not teach magnesium oxide as a hygroscopic agent. Applicant further argues He does not disclose any specific formulation or powder composition and does not address organoleptic properties, particle size, or physical structure of a nutritional powder. Applicant further argues He’s study provides no teaching or suggestion relevant to Barry’s composition for achieving the distinct physical and sensory characteristics described in the present application. Applicant provides the magnesium content in one to three servings of Barry’s oral powder composition, and claims that He does not prescribe an optimal dose or formulation percentage nor motivate the skilled person to exceed high-intake levels disclosed in Table 1 of He. Applicant further argues a skilled person reading Barry in view of He would only aim for “high-intake” daily magnesium, since He reports the highest quartile of magnesium intake had a 31% lower risk of metabolic syndrome compared to the lowest. Applicant argues that Barry achieves the “high-intake” at the second to third serving. Applicant further argues that He does not disclose or suggest exceeding such a high-intake. Applicant argues a skilled person would not raise the magnesium content in Barry’s composition if taken over two to three servings and would only modestly increase the magnesium level in a single serving. Lastly, Applicant argues the only motivation He provides is to increase the magnesium oxide heavy content for nutritional supplementation purposes and not a functional hygroscopic effect. Applicant claims this motivation would teach away from employing porous or encapsulated MgO grades used in the present invention. This is not found persuasive.
Applicant’s arguments with regard to Barry not teaching magnesium oxide as a hygroscopic agent have been addressed in the response above. The rejection does not rely on He to teach a powder composition, which is taught by Barry. He provides a reasonable motivation to optimize the concentration of magnesium oxide already present in the oral powder composition of Barry. Moreover, Applicant’s arguments with regards to organoleptic properties, particle size, physical structure of a nutritional powder, and the distinct physical and sensory characteristics described in the present application are not commensurate in scope with the limitations recited in claim 1. Examples 1-2 in the specification disclose specific features that are attributed to improving taste, i.e., organoleptic properties, that are not recited in claim 1, such as particle size and a mixture of xylitol and erythritol sweeteners. Moreover, the examples are silent with respect to the concentrations of each component of the powder composition. Applicant’s arguments with respect to the magnesium intakes presented in the quartiles of Table 1 assumes a kcal intake of 2000 kcal/day, yet He is silent with regards to the actual kcal intakes. He specifically discloses that kcal intakes included in their data pool for men were a range of 800-8000 kcal/d and 600-6000 kcal/d for women (see p.1676, left column, 1st paragraph). Thus, there is no basis for limiting the magnesium intake in the highest quartile to 2000 kcal/day and to extrapolate the calculated magnesium intake to Barry’s composition as Applicant suggests. Furthermore, there is no teaching in He to suggest that magnesium intake should not exceed the concentration range in the highest quartile. He’s demonstration that higher magnesium intake in a daily diet resulted in significantly lower risk of metabolic syndrome would motivate a skilled artisan to increase magnesium intakes in products intended for attenuating metabolic syndrome, such as that of Barry’s. Even if the skilled artisan would have been motivated to increase magnesium in Barry’s composition for nutritional supplementation purposes, as Applicant has admitted, magnesium oxide heavy still possesses hygroscopic properties and would have hygroscopic affects in the composition. MPEP § 2144(IV) sets forth that rationales that differ from Applicant’s is permissible, and it is not necessary that the prior art suggest the combination achieves the same advantage or result discovered by Applicant. Lastly, Applicant’s arguments regarding employing porous or encapsulated MgO grades is not commensurate in scope with the claimed invention which does not recite porous or encapsulated magnesium oxide.
In Applicant’s Remarks, see p.9, last paragraph-p.10, last paragraph, Applicant argues that the cited combination of references fails to teach or suggest 35-95% of the particles in the claimed powder composition have a size less than or equal to 200 μM. Applicant argues that Onwulata’s work on whey protein powders is unrelated to probiotic compositions and provides no motivation to be applied to Barry’s formulation. Applicant further argues that 35-95% of particles having a size less than or equal to 200 μM contributes to fast-melting, non-gritty mouthfeel during ingestion and that Onwulata does not appreciate these features. Applicant argues the claimed features produce an unexpected effect. Applicant argues that a person of ordinary skill in the art looking to Onwulata would strive to obtain a very fine powder; whereas, the claimed invention is a controlled particle size distribution. Applicant argues Onwulata teaches away from the claimed invention and for purposes different from Applicant’s. This is not found persuasive.
The rejection as set forth demonstrates that one of ordinary skill in the art looking to Barry in view of Onwulata would seek to refine the size of the whey protein to particle sizes ranging from 100 to 150 μM in the composition of Barry. The person of ordinary skill would be motivated to refine the particle size of the whey protein since Onwulata teaches an improved solubility. The whey protein in the oral composition of Barry constitutes 56.18% w/w of the total composition. Thus, if the skilled artisan were to look to Onwulata and apply the teachings to Barry, they would be motivated to refine the whey protein of Barry to particle sizes in the range of 100 to 150 μM. The resulting oral powder composition of Barry in view of Onwulata would have 56.18% particles at a size ranging from 100 to 150 μM, reading on the claimed invention. Barry’s oral powder composition is disclosed as typically being dissolved in liquids. Thus, the teachings of Onwulata are relevant to composition Barry and do not teach away. Moreover, Onwulata recognizes that the finer particles sizes results in improved solubility, and thus it would be obvious that the composition melts faster, since the composition is essentially being solubilized by saliva in the mouth. In view of what Onwulata teaches, faster melting and decreased gritty-feel in the mouth are not unexpected results.
In Applicant’s Remarks, see p.11, 3rd paragraph,-p.12, 1st paragraph, Applicant argues that routine optimization would not explain a 3-5x increase in a bitter, mouthfeel-active mineral in a fast-melt oral powder. Applicant further argues the prior art of record, alone or in combination, do not teach the specific combinations of recited elements in claim 32 nor the specific ranges of the elements. Applicant further argues that the composition of Barry is intended to be reconstituted in water, while the present invention relates to powders intended for direct ingestion with fast melting/cooling mouthfeel. Applicant further argues that the combination of prior art does not address the formulation problem or the claimed solution. Applicant states the proposed combination of references appears to rely on improper hindsight. Applicant further argues that there is no teaching or suggestion to (a) raise MgO to 4-7 % in an on-tongue fast-melt powder, while (b) locking erythritol and xylitol at 70-95 %, and (c) selecting LGG+BL-04 at 1 to 3 %. Applicant argues these limitations results in a fast-melting mouthfeel and formulation constraints, such as water activity and taste, which is neither disclosed nor suggested by any of the cited prior art of record, alone or in combination. This is not found persuasive.
Regarding Applicant’s arguments with respect to a fast-melting product with increase in bitter, mouthfeel-active mineral, these arguments are not commensurate in scope with claimed invention. The claimed invention is directed to a nutritional powder product and does not require the composition to be consumed in a specific manner as argued by Applicant. Additionally, the rejection of claim 32 provides specific motivations to combine the cited prior art references. Barry teaches weight loss and/or fat loss compositions and discloses an oral powder composition that comprises the probiotics Lactobacillus acidophilus LA14 and Bifidobacterium lactis BL-04 at a total of 0.05% w/w ((0.469 g L. acidophilus LA14 + 0.052 g B. lactis BL-04)/1001.159 g total), magnesium oxide, the low calorie/bulk sweetener xylitol, the flavored aroma compounds vanilla and cream at a total of 2.58% w/w ((12.35 g vanilla flavor + 13.547 g cream flavor)/1001.159 g total), and the antioxidants vitamins A, C, and E, as discussed in the rejection of claim 1 above (see Example 1). Barry further teaches the probiotic microorganism may be one or more Lactobacillus species including Lactobacillus rhamnosus (see p.8, 2nd-3rd passages). Barry further teaches their compositions include at least one sugar alcohol that functions as a sweetener and teaches sweetener erythritol (see p.9, 5th passage). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have further included erythritol in the oral powder composition of Barry to provide a sweeter composition. He teaches magnesium intake is inversely associated with incidence of metabolic syndrome in a dose responsive manner (see Abstract, p.1675, right column, 1st paragraph, and paragraph bridging p.1677 and p.1678). It would have been obvious to increase the concentration of magnesium oxide in the composition of Barry in order to optimize the weight loss effects of Barry’s composition, since Kim teaches increased magnesium intake decreases metabolic syndrome. Kim teaches Lactobacillus rhamnosus GG has shown several beneficial effects such as improved insulin sensitivity and attenuated weight gain in a high fat diet group of mice treated with L. rhamnosus GG (see Abstract, p.259, right column, 2nd paragraph, and Fig. 1). Thus, an ordinarily skilled artisan would be motivated to substitute L. rhamnosus GG for L. acidophilus LA14, in order to provide the weight attenuation and improved insulin sensitivity attributes of L. rhamnosus GG to the composition intended for weight loss of Barry, yielding predictable results. Abdulmumeen teaches acid food additives are incorporated into food products to make flavors “sharper” and act as preservatives and antioxidants (see p.43, right column, “10. Classification of food additives; Acids”). Abdulmumeen teaches common food acids include vinegar, citric acid, tartaric acid, malic acid, fumaric acid, and lactic acid. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have further included citric acid food acid additive, as taught by Abdulmumeen, to the oral powder composition of Barry to sharpen the flavor of the composition and further preserve the composition. With regards to the specifically claimed weight concentrations, the person of ordinary skill in the art would have found it obvious to routinely optimize the sweetness by increasing the sweeteners xylitol and erythritol, the probiotic properties increasing the amount of probiotics, and the enhancement of flavor and preservation of the composition through the addition of citric acid. Therefore, the rejection clearly sets forth motivation to arrive at the claimed invention that does not rely on improper hindsight. Applicant’s arguments with respect to water activity are not commensurate in scope with the claimed invention because this is not a limitation recited in claim 32.
In Applicant’s Remarks, see paragraph bridging p.12-13-p.14, 1st paragraph, Applicant reiterates the arguments presented above, which have been addressed in the previous replies. Furthermore, Applicant’s arguments with respect to the limitations of claims 39-41 have been previously addressed. With respect to claim 38, Applicant argues Barry’s composition is intended for reconstitution in liquid and not direct ingestion of the powder as claimed. Applicant further argues the fast melting properties and on-tongue cooling/rapid dissolution are realized in the direct ingestion of the claimed invention. This is not found persuasive.
Barry teaches the oral powder composition is typically dissolved in water or other liquid to be taken once to three times daily (see Example 1 – p.15, last passage). This implies that the oral powder composition disclosed in Example 1 does not necessarily need to be dissolved in liquid for consumption. In fact, The Storm’s YouTube video provides evidence that dry protein powder can be eaten directly without reconstitution in liquid. Barry does not teach or suggest that the only way to consume the powder is through reconstitution, as Applicant suggests. Therefore, the oral powder composition of Barry reads on wherein the composition is formulated for oral ingestion in powder form, as claimed.
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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/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
/J.P.S./Examiner, Art Unit 1657