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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-9, 11, 13, 15 and 20) in the reply filed on 10/21/2025 is acknowledged claims 1-9, 11, 13, 15, 20 and newly added claims 35-41 are examined in this application.
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 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 factual inquiries 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 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.
Claims 1-9, 11, 13, 15, 35, 36, 37, 38, 39, 40, 41 are rejected under 35 U.S.C. 103 as being unpatentable over US 2017/0156389 Al to N.V. Nutricia (hereinafter Nutricia '389), in view of Bhargava US 2016/0192682 A1 to University of Central Oklahoma (hereinafter Bhargava).
Regarding claim 1, Nutricia '389 discloses of a composition (para [0032]: "The invention can also be worded as a nutrition composition comprising...") comprising fermented milk (para [0035]: "...a protein comprising composition fermented by lactic acid bacteria... "; para (0065]: "The present nutritional composition comprises a protein comprising composition fermented by lactic acid bacteria... preferably comprises a fermented milk-derived protein comprising composition") and one or more proteins, …proteins are selected from the group consisting of dairy and plant proteins (para [0033]: "...protein in an amount of 5 to 20 weight percent based on dry weight of the nutritional composition..."; para [0079]: "The present nutritional composition comprises a protein component…. The protein … nutritional composition is preferably selected from... milk proteins, vegetable proteins, such as preferably soy protein and/or rice protein, and mixtures thereof"), wherein the composition has a pH of 5-7.5 (para [0076]: "The pH of the present nutritional composition is preferably between 5.0 and 7.5...").
Nutricia '389 does not disclose that the fermented milk comprises one or more viable microorganisms or that the pH is from 7-8. However, it would have been obvious to one of ordinary skill in the art to have the pH of the composition be between 7-8, based on the teachings of Nutricia '389. since Nutricia '389 discloses that the pH can be from 7-7.5, as discussed above. Further, while Nutricia '389 discloses that, in one specific embodiment, the majority of the microorganisms in the fermented milk are inactivated (para [0065]): "In one embodiment, after incubation the incubated composition is preferably subjected to a heat treatment. By this heat treatment preferably at least a percent of living microorganisms are inactivated... inactivation of the lactic acid bacterium advantageously results in less post acidification and a safer product. This is especially advantageous when the nutritional composition is to be administered to infants or toddlers"). Thus, Nutricia ‘389 teaches inactivation of lactic acid bacteria for vulnerable consumers, such as, infants and toddlers. Nutricia ‘389 recognizes that some CFUs living lactic acid bacteria/ gram based on dry weight (Para [0065]), which is further subjected to heat treatment for infants and toddler food.
However, in a similar invention comprising fermented milk, Bhargava discloses that production of probiotic functional foods yogurt and kefir are both specific types of fermented milk (para [0016]: "Yogurt … class of fermented dairy products …kefir …produced using a combination of yeasts and probiotic bacteria"). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to skip the extra heat treatment and retain the viable bacteria in the fermented milk containing nutritional composition, for regular consumer populations. It would have been a matter of routine determination for one of ordinary skill to retain the viable bacteria in the fermented milk containing nutritional composition, for consumer populations other than infants and toddlers. One of ordinary skill before the effective filing date of the invention would have been motivated to modify Nutricia ‘389, at least for the purpose of providing a nutritional benefit of ingesting one or more types of viable microorganisms for populations including adults, athletes, etc. One of ordinary skill would have been also motivated to eliminate the added heating step and reduce manufacturing cost to create a nutritional product with viable bacterial population suitable for a particular user ingesting the composition.
Regarding claim 2, Nutricia '389 discloses of the composition of claim 1, as discussed above, where, milk can be skim milk, i.e., nonfat milk (Para [0065]). However, Nutricia '389 does not disclose what type of fermented milk is used. However, it would have been obvious to one of ordinary skill in the art through routine experimentation to select a particular type of milk, such as fermented cow milk or fermented coconut milk, in order to form a nutritional composition made for a specific user, e.g. a dairy-based nutritional formula or a vegan nutritional formula, etc.
Regarding claim 3, Nutricia '389 further discloses of the composition of claim 1, wherein the fermented milk is prepared from milk selected from skim milk or a derivative milk product (para [0065]) : "This fermented milk-derived protein comprising composition is obtained by incubation of a combination of milk, e.g. skim milk, or a milk derived product, e.g. whey, with at least one strain of lactic acid bacterium..."). However, Nutricia '389 does not specify that the milk is fresh whole milk, reconstituted whole milk, reconstituted non-fat dry milk and combinations thereof. However, it would have been obvious to one of ordinary skill in the art through routine experimentation to use reconstituted whole milk, reconstituted non-fat dry milk, and combinations thereof, based on the teachings of Nutricia '389, since Nutricia '389 discloses that the milk can be a derivative milk product, as discussed above.
Regarding claim 4, Nutricia '389 discloses of the composition of claim 1 comprising fermented milk, as discussed above. However, Nutricia '389 does not disclose that the fermented milk is selected from the group consisting of yogurt, kefir, cheese, buttermilk. sour cream and combinations thereof. However, in a similar invention, Bhargava discloses that yogurt and kefir are both specific types of fermented milk (para [0016]: "Yogurt … class of fermented dairy products. Traditional yogurt is a fermented product made using milk produced by animals (e.g., cows. goats, and sheep). Traditional kefir is a fermented milk product produced using a combination of yeasts and probiotic bacteria"). Therefore, it would have been obvious to one of ordinary skill in the art to combine the teachings of Nutricia '389 and Bhargava and form the composition of claim 1 comprising fermented milk, as disclosed by Nutricia '389, wherein the fermented milk is yogurt or kefir, based on the teachings of Bhargava, since Bhargava discloses that both yogurt and kefir are particular types of fermented milk.
Regarding claim 5, Nutricia '389 discloses of the composition of claim 1 comprising fermented milk, as discussed above. However, Nutricia '389 does not disclose that the fermented milk is kefir. However. in a similar invention, Bhargava discloses that kefir is a specific type of fermented milk (para [0016]: "Traditional kefir is a fermented milk product produced using a combination of yeasts and probiotic bacteria"). Therefore, it would have been obvious to one of ordinary skill in the art to combine the teachings of Nutricia '389 and Bhargava and form the composition of claim 1 comprising fermented milk, as disclosed by Nutricia '389, wherein the fermented milk is kefir, based on the teachings of Bhargava, since Bhargava discloses that kefir is a particular type of fermented milk.
Regarding claim 6, Nutricia '389 discloses of the composition of claim 1, comprising one or more proteins. as discussed above. Wherein “proteins are concentrated, isolated, partially hydrolyzed or hydrolyzed proteins”, see Para 73 and 79 where protein in the fermented composition is casein and whey proteins in the weight ratio of 10:90 to 90:10, and para 79 also soy protein, rice protein, and free amino acids, i.e., proteins that are concentrated or isolated or at least partially hydrolyzed are taught by Nutricia '389 .
Regarding claim 7, Nutricia '389 further discloses of the composition of claim 1, wherein the one or more proteins are selected from the group consisting of casein, whey protein, pea protein, soy protein and combinations thereof (para [0079]: "The protein used in the nutritional composition is preferably selected from the group consisting of non-human animal proteins, preferably milk proteins. vegetable proteins, such as preferably soy protein and/or rice protein, and mixtures thereof').
Regarding claim 8. Nutricia '389 further discloses of the composition of claim 1, wherein the composition comprises 5-35 wt.% of the one or more proteins, based on the dry weight of the composition (para [0033: "...protein in an amount of 5 to 20 weight percent based on dry weight of the nutritional composition...").
Regarding claim 9 and 35, Nutricia '389 discloses further comprising one or more sugars selected from the group consisting of glucose, fructose, sucrose, trehatose, lactose, maltose, isomaltose and combinations thereof (para [0100]: "The present nutritional composition comprises a digestible carbohydrate component. Preferred digestible carbohydrate components are lactose, glucose. sucrose, fructose, galactose, maltose..."). regarding the limitation of claim 35, wherein the composition comprises 10-50 wt.% of the one or more sugars, based on the dry weight of the composition, Nutricia ‘389 teaches lactose as the sugar and para [0100]: "Based on dry weight the present nutritional composition preferably comprises at least 25 wt. % lactose.”, which falls in the claimed range.
Regarding claims 11 and 36, Nutricia '389 discloses comprising one or more oligosaccharides selected from the group consisting of inulin, short-chain oligosaccharides, cyclodextrins, maltodextrins, dextrans, fructo-oligosaccharides (FOS), galacto-oligosaccharides (GOS), mannan-oligosaccharides (MOS), and combinations thereof, and claim 36 which depends from claim 11, and limits the amount oligosaccharide to “5-35 wt.%” based on the dry weight of the composition ([0086]: oligosaccharides “fructo-oligosaccharides (FOS)…inulin, non-digestible dextrins, galacto-oligosaccharides (GOS), mannan-oligosaccharides (MOS)” and [0053] “non digestible oligosaccharides are present in an amount of 0.5 to 20 wt. % based on dry weight of the nutritional composition”), which fall in the claimed range.
Regarding claims 13 and 37, Nutricia '389 discloses further comprising one or more carboxylic acid salts, and wherein the one or more carboxylic acid salts are one or more salts of one or more carboxylic acids selected from the group consisting of lactic acid, ascorbic acid, maleic acid, oxalic acid, malonic acid, malic acid, succinic acid, citric acid, gluconic acid, glutamic acid, tartaric acid, and combinations thereof ([([0025-0026] where lactic acid and lactate are taught). Further, regarding claim 37, which depends from claim 13, Nutricia '389 discloses The composition of claim 13, wherein the composition comprises 1-10 wt.% of the one or more carboxylic acid salts, based on the dry weight of the composition, ([0026]: “0.10 to 1.5 wt. % of the sum of lactate and lactic acid based on dry weight of the nutritional composition and wherein the sum of L-lactic acid and L-lactate is more than 50 wt. % based on the sum of total lactic acid and lactate.”), where the carboxylic acid content overlaps the recited range for claim 37.
Regarding the overlapping of ranges between the invention and prior art composition it is noted that in the case where the claimed ranges "overlap or lie inside the ranges disclosed by the prior art" a prima facie case of obviousness exists (In re Wertheim, 541 F2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F2d 1575, 1578, 16 USPQ2d 1934, 1936 (Fed. Cir. 1990)).
Regarding claims 15, and 40, Nutricia '389 discloses a composition further comprising one or more sugars ([0100], as applied to claim 9), one or more oligosaccharides ([0086], as applied to claim 11) and one or more carboxylic acid salts ([0025-0026] where lactic acid and lactate are taught), where lactic acid is carboxylic acid listed in claim 40 which depends from claim 15, and recites the same list of carboxylic acid salts as recited in claim 13.
Claims 38 and 39 recite the same limitations as claims 9 and 11 but differ only in their dependence from claim 15. Claims 38 and 39 are therefore rejected for the same reasons as provided above for claims 9 and 11 respectively.
Regarding claim 41, further comprising a flavoring agent, Nutricia '389 discloses addition of sugars ([Para [0100], [0155]), where sugar/ sucrose s taught which imparts sweet flavor. Further inclusion of flavoring agents to wither impart of modify flavor of a fermented composition was well-known in the art before the effective filing date of the invention as taught by Bhargava (para [0054] where option of addition of “flavorings or nutritional additives”, also see para [0091] and claim 41). Although Nutricia '389 teaches sugar that imparts sweet flavor, adding flavors to achieve fermented product having characteristics like flavor closer to a traditional artisan flavors that are popular with consumers would have been obvious to one of ordinary skill in the art and one of ordinary skill in the art would have been motivated to modify Nutricia ‘389 and include flavorings other than sugar to the fermented mil product before the effective filing date of the invention at least for the purpose of achieving a fermented product having characteristics like flavor closer to a traditional artisan flavors (as taught by Para [0034] and [0078]) of Bhargava) that are traditionally popular with consumers.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Nutricia '389, in view of Bhargava as applied to claims 1-9, 11, 13, 15, 35-41 above, further in view of Cravero (US 6033691A), hereinafter Cravero.
Regarding claim 20, that recites a composition wherein the viable microorganisms comprise viable Lactobacilli having an initial viability of at least 1x108colony forming units (CFU) over the dry weight of the composition (CFU/g), and wherein the composition loses less than 1 log CFU/g of the viable Lactobacilli after being stored for at least 84 days at a temperature of 40°C and a relative humidity of 33%.
The recitation “wherein the viable microorganisms comprise viable Lactobacilli having an initial viability of at least 1x108colony forming units (CFU)” appears to refer to viability during a stage of processing (as evidenced by “initial viability”). As such any comparison to this initial viability to a viability at another stage of processing is a process detail and not the structure of the final product. Further the recitation “wherein the composition loses less than 1 log CFU/g of the viable Lactobacilli after being stored for at least 84 days at a temperature of 40°C and a relative humidity of 33%” also appears to be a detail of an intermediate product step and not a property of the final product. Claim 20 recites the limitation of measuring the lactobacillus population during the process of fermentation and also during a later step of storage under specific temperature and humidity conditions, which are process limitation. As such claim 20 is a product-by-process claim. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). When the reference teaches a product that appears to be the same as, or an obvious variant of, the product set forth in a product-by-process claim although produced by a different process. See In re Marosi, 710 F.2d 799, 218 USPQ 289 (Fed. Cir. 1983) and In re Thorpe, 777 F.2d 695, 227 USPQ 964 (Fed. Cir. 1985). See also MPEP § 2113.
Assuming that the recitation of “viability of at least 1x108colony forming units (CFU) over the dry weight of the composition (CFU/g)” is present in the finished product, it is noted that at the time of the effective filing date of the invention had knowledge that probiotics ad in the health of the human gut and digestion, as taught by Bhargava.
Further, Nutricia '389 in view of Bhargava as applied to claim 1 above, teaches a product comprising viable bacterial cultures and specifically lactobacilli, which is an obvious variant of the product where live or active or viable bacteria can be present in a fermented food product. Regarding the inclusion of a specific proportion of active bacterial cultures in a finished fermented product “viable Lactobacilli having an initial viability of at least 1x108colony forming units (CFU) over the dry weight of the composition (CFU/g)”, applicant is referred to Cravero Column 2, lines 36-46 and claim 14 where “A fermented milk product in a liquid form or in a powder form which can be instantaneously reconstituted and is produced by the method of claim 1, comprising the co-culture of Streptococcus thermophilus and Lactobacillus casei …. and Lactobacillus acidophilus … in a milk substrate, up to a concentration of Lactobacillus viable cells not less than 105 -109 CFU/ml” (see claim 14), which includes viable bacteria in the claimed range. Given that relationship between probiotics and gut health and digestion of humans was known before the effective filing date of the invention. It would have been a matter of routine determination for one of ordinary skill to retain the viable bacteria in the fermented milk containing nutritional composition, for consumer populations other than infants and toddlers. One of ordinary skill before the effective filing date of the invention would have been motivated to modify Nutricia ‘389 based on the teaching of Cravero, at least for the purpose of providing a nutritional benefit of ingesting one or more types of viable microorganisms in dosage that is found effective to improve gut health and digestion in consumer populations including adults, athletes, etc. by ingesting a nutritional product with desired level of viable bacterial population suitable for a particular user ingesting the composition.
Regarding claim 20, it is also noted that the recitation of “composition loses less than 1 log CFU/g of the viable Lactobacilli after being stored for at least 84 days at a temperature of 40°C and a relative humidity of 33%.”, is described in parameters that can not be measured by the patent office. In the instant case, applicant has described the product with parameters and equations which cannot be measured by the office for prior art comparison, because the office is not equipped to manufacture prior art products and compare them for patentability purposes. Therefore, as a prima facia case of obviousness has been properly established, the burden is shifted to the applicant to show that the prior art product is different.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JYOTI CHAWLA whose telephone number is (571)272-8212. The examiner can normally be reached on M-F 9:30- 5:30.
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 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.
/JYOTI CHAWLA/
Primary Examiner, Art Unit 1791