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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02/06/2026 has been entered.
Response to Amendment
The amendment filed 02/06/2026 has been entered. Claims 1-2 and 5-7 remain pending in the application. The provisional nonstatutory double patenting rejection over copending Application No. 17/517,848 has been withdrawn in view of the abandonment of copending Application No. 17/517,848.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-2 and 5-7 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, the meaning of “wherein the dairy composition has lower water activity and increased sweetness compared to a comparable composition lacking the lactose hydrolysis products and the glucosylated natural steviol glycosides” is unclear because the term “comparable composition” has not been clearly defined in the claims or specification. Does a “comparable composition” refer to dairy composition containing only a caloric sweetener, a dairy composition that may comprise any ingredients except lactose hydrolysis products and glucosylated natural steviol glycosides, or something else entirely? Due to the unclear scope and meaning of “comparable composition”, claim 1 is rejected as indefinite.
Claims 2 and 5-7 are rejected as indefinite as a result of depending upon indefinite claim 1.
Claim Rejections - 35 USC § 103
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.
Claim(s) 1-2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carrigan (US 20120040052 A1) in view of Purkayastha ( US 20180035702 A1) and Ashokan (US 20130034648 A1).
Regarding claim 1, Carrigan teaches (Paragraph 0001, 0030) a low or zero lactose milk (dairy composition) prepared by a process comprising enzymatically hydrolysing the lactose present in mammalian milk. Carrigan further teaches (Table 7) an exemplary embodiment of a reduced lactose semi-skimmed bovine milk (dairy composition) comprising glucose and galactose, (lactose hydrolysis products). Also, Carrigan teaches (Paragraph 0087) the product may comprise ingredients selected from a list including sugars and sweeteners. Furthermore, Carrigan teaches (Paragraph 0094) the reduced lactose or lactose free milk may have no additional sweetness, or may have a higher relative sweetness such as is desirable from a sensory perspective depending on national preferences.
Carrigan is silent on the composition comprising glucosylated natural steviol glycosides at a concentration ranging from 1 ppm to 300 ppm. Carrigan is further silent on the dairy composition comprising a caloric sweetener at a concentration ranging from a sucrose equivalence of 0.5 *Bx to a sucrose equivalence 5 *Bx.
Purkayastha teaches (Paragraph 0011,0012; Claim 10) a taste and flavor profile enhancing composition, wherein the composition includes glucosylated steviol glycosides which can enhance the intensity of a taste and/or a flavor in a food or beverage product, including dairy foods and dairy beverages, wherein steviol glycosides are extracted from leaves of a Steviol rebaudiana Bertoni plant (natural). Also, Purkayastha teaches (Paragraph 0053) an exemplary embodiment wherein a flavored dairy beverage has a glucosylated steviol glycoside concentration preferably in the range of about 50 to 500 ppm (which overlaps with the claimed range of 1 ppm to 300 ppm). Additionally, Purkayastha teaches (Paragraph 0074) an exemplary embodiment wherein a chocolate milk has a glucosylated steviol glycoside concentration preferably in the range of about 50 to 400 ppm (which overlaps with the claimed range of 1 ppm to 300 ppm).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify Carrigan to incorporate glucosylated natural steviol glycosides in the composition at a concentration ranging from 1 ppm to 300 ppm in view of Purkayastha since both are directed to food products including dairy compositions, since incorporating glucosylated natural steviol glycosides in food products including dairy compositions in concentrations of 50 to 500 ppm and 50 to 400 ppm (which overlap with the claimed range of 1 ppm to 300 ppm) is known in the art as shown by Purkayastha, since a composition including glucosylated steviol glycosides can enhance the intensity of a taste and/or a flavor in a food or beverage product (Purkayastha, Paragraph 0011), since the mouthfeel of a food or beverage product including the taste and flavor enhancing composition, wherein the taste and flavor enhancing composition includes glucosylated steviol glycosides, may be improved in relation to a mouthfeel of a comparative food or beverage product which does not include the taste and flavor enhancing composition (Purkayastha, Paragraph 0012), since concentrations overlapping with the claimed range are known to successfully enhance the flavor and sweetness of dairy compositions as demonstrated by Purkayastha, and since excessive glucosylated steviol glycosides concentration would render a beverage overly sweet and unpalatable, while too low a concentration would have a negligible effect and fail to improve the sweetness or flavor of the beverage.
Furthermore, the claimed concentration for glucosylated natural steviol glycosides ranging from 1 ppm to 300 ppm would have been used during the course of normal experimentation and optimization procedures in the method of Carrigan, as modified above, based upon factors such as the amount of the dairy composition consumed by the consumer, the consumer’s desired or needed caloric intake (where glucosylated steviol glycosides can provide sweetness without increasing the calorie content of the composition), the intended sweetness level of the composition, the presence and amount of other sweeteners, consumer preferences in sweetness, etc. Furthermore, the Applicant does not appear to have identified any unique or unexpected benefit from the claimed concentration for glucosylated natural steviol glycosides ranging from 1 ppm to 300 ppm that would render it non-obvious.
Ashokan teaches (Paragraph 0002, 0017, 0036) a partially frozen beverage including betaine, wherein beverages include milk-based drinks (dairy compositions), and wherein, in some embodiments, the partially frozen beverage may include a brix level of natural-caloric sweeteners from about 3° Bx to about 6° Bx (which overlaps with the claimed range of 0.5 °Bx to 5 °Bx).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify Carrigan to include a caloric sweetener in the dairy composition with a brix level of natural-caloric sweeteners from about 3° Bx to about 6° Bx (which overlaps with the claimed range of 0.5 °Bx to 5 °Bx) as taught by Ashokan since both are directed to dairy compositions including sweeteners, since including a caloric sweetener in the dairy composition with a brix level of natural-caloric sweeteners from about 3° Bx to about 6° Bx (which overlaps with the claimed range of 0.5 °Bx to 5 °Bx) is known in the art as shown by Ashokan, since many consumers desire food products containing natural ingredients, since caloric sweeteners provide energy necessary for bodily functioning, since sweeteners can improve the taste and flavor of a food product for many consumers, since too low a brix level would provide inadequate sweetness while too high a brix level would provide excess sweetness and excess calories that would be undesirable and unhealthy for the consumer, and since sweeteners included in a partially-frozen consumable item may be used in controlled amounts and proportions in order to optimize the taste characteristics of a partially-frozen beverage (Ashokan, Paragraph 0050).
Furthermore, the claimed concentration for a caloric sweetener ranging from a sucrose equivalence of 0.5 °Bx to a sucrose equivalence 5 °Bx would have been used during the course of normal experimentation and optimization procedures in the method of Carrigan, as modified above, based upon factors such as the amount of the dairy composition in a consumer’s serving, the consumer’s desired or needed caloric intake (where different consumers require different amounts of calories and increasing the brix level will raise the number of calories per serving), the intended sweetness level of the composition, the presence and amount of other sweeteners, consumer preferences in sweetness, etc. Furthermore, the Applicant does not appear to have identified any unique or unexpected benefit from the claimed concentration for a caloric sweetener ranging from a sucrose equivalence of 0.5 °Bx to a sucrose equivalence 5 °Bx that would render it non-obvious.
Additionally, since the claimed product is obvious in view of Carrigan, as modified above, the claimed features of a lower water activity would have been taught by the combination and the claimed feature of an increased sweetness compared to a comparable composition lacking the lactose hydrolysis products and the glucosylated natural steviol glycosides would necessarily be present. Since the prior art teaches the claimed composition, it would be expected to perform in a similar manner. Furthermore, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Regarding claim 2, Carrigan teaches (Paragraph 0097; Table 7) the process includes the steps of enzymatically treating mammalian milk with lactose enzyme to hydrolyse lactose to galactose and glucose and an exemplary embodiment of a reduced lactose semi-skimmed bovine milk (dairy composition) comprises (per 100 ml) 2.11 g of glucose and 2.11 g of galactose.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carrigan (US 20120040052 A1) in view of Purkayastha ( US 20180035702 A1) and Ashokan (US 20130034648 A1) and further in view of Prakash (US 20160029677 A1).
Regarding claim 5, Carrigan, as modified above, is silent on the concentration of glucosylated natural steviol glycosides in the dairy composition ranging from a sucrose equivalence of 1 °Bx to a sucrose equivalence of 10 °Bx.
Prakash teaches (Paragraph 0084) a composition comprising a compound of formula (1) provided as part of a mixture selected from the group consisting of a GSG (glucosylated steviol glycosides) mixture prepared by enzymatic glucosylation of a stevia extract, where the stevia extract was prepared from Stevia rebuadiana (Bertoni) or a commercially available stevia extract; by-products of other glucosyl steviol glycosides' isolation and purification processes; a commercially available GSG mixture; individual glucosylated steviol glycosides and combinations thereof, wherein, in one embodiment, a sweetener composition comprises a compound of formula (1) in an amount effective to provide sweetness equivalent from about 0.50 to 14 degrees Brix of sugar when present in a sweetened composition, such as, for example, from about 5 to about 11 degrees Brix, from about 4 to about 7 degrees Brix, or about 5 degrees Brix. Prakash further teaches (Paragraph 0387) in one embodiment, the consumable of the present invention is a dairy product that comprises a compound of formula (1), wherein dairy products, as used herein, comprise milk or foodstuffs produced from milk.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify Carrigan, as modified above, to provide the composition with a sweetness equivalent between 1°Bx and 10°Bx, as taught by Prakash since both are directed to compositions, including dairy and milk compositions, containing sweeteners, since adding glucosylated steviol glycosides to a composition that may be a dairy composition to provide a sweetness equivalent between 1°Bx and 10°Bx is known in the art as shown by Prakash, since the Stevia rebuadiana extracts from which GSGs are prepared, often have bitter or astringent taste characteristics that are improved by carrying out enzymatic glucosylation (Prakash, Paragraph 0004), since too little of the GSG may be undetectable or provide a negligible impact on the taste, flavor, or sweetness of the dairy composition, and since an excess amount of GSG may produce an overly sweet dairy composition that consumers do not desire.
Furthermore, the claimed concentration of glucosylated natural steviol glycosides in the dairy composition would have been used during the course of normal experimentation and optimization procedures in the method of Carrigan, as modified above, based upon factors such as the desired sweetness and flavor of the dairy composition (where too little of the GSG would be undetectable or provide a negligible impact on the taste, flavor, or sweetness of the dairy composition, while an excess amount of GSG would produce an overly sweet dairy composition that consumers do not desire), the intended texture or viscosity of the dairy composition, the intended nutritional impact, etc. Furthermore, the Applicant does not appear to have identified any unique or unexpected benefit from the claimed concentration that would render it non-obvious.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carrigan (US 20120040052 A1) in view of Purkayastha ( US 20180035702 A1) and Ashokan (US 20130034648 A1) and further in view of FructoseFacts and Navarro et al. (Importance of sucrose in cognitive functions: knowledge and behavior).
Regarding claims 6, Carrigan teaches (Paragraph 0087) the product may comprise ingredients selected from a list including sugars and sweeteners.
Carrigan is silent on the caloric sweetener being sucrose, fructose, or a combination thereof.
As shown above, Ashokan teaches (Paragraph 0002, 0017, 0036) a partially frozen beverage including betaine, wherein beverages include milk-based drinks (dairy compositions), and wherein, in some embodiments, the partially frozen beverage may include a brix level of natural-caloric sweeteners from about 3° Bx to about 6° Bx (which overlaps with the claimed range of 0.5 °Bx to 5 °Bx). Ashokan further teaches (Paragraph 0020) natural caloric sugars may include by way of nonlimiting example fructose, glucose, sucrose, and a combination of any of the foregoing.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify Carrigan to include provide sucrose, fructose, or a combination thereof as the caloric sweetener in the dairy composition in view of Ashokan since both are directed to dairy compositions including sweeteners, since including a caloric sweetener in the dairy composition that may be sucrose, fructose, or a combination thereof is known in the art as shown by Ashokan, since sucrose and fructose are naturally occurring sugars and many consumers desire food products containing natural ingredients, since caloric sweeteners like fructose and sucrose provide energy necessary for bodily functioning, since sweeteners included in a partially-frozen consumable item may be used in controlled amounts and proportions in order to optimize the taste characteristics of a partially-frozen beverage (Ashokan, Paragraph 0050), since fructose is the sweetest of all nutritive sweeteners, interacts with other sweeteners and starches in a synergy that boosts the sweetness and viscosity of foods and beverages, and binds and retains moisture so well that it can replace sorbitol and glycerin in foods, thereby improving taste (FructoseFacts), and since the consumption of food or drink with sucrose is associated with an improvement in mental agility, memory, reaction times, attention and capacity to resolve mathematical problems, as well as reduction in the sensation of tiredness (Navarro et al., Page 109).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carrigan (US 20120040052 A1) in view of Purkayastha ( US 20180035702 A1) and Ashokan (US 20130034648 A1) and further in view of Inoue (US 20070212460 A1).
Regarding claims 7, Carrigan teaches (Paragraph 0125) it is possible to add additional ingredients to the hydrolysed milk blend for example one or more of the following non-limiting ingredients including sugars and sweeteners.
Regarding claim 7, Carrigan is silent on the dairy composition further comprising sucralose, rebaudioside A, or a combination thereof.
Inoue teaches (Paragraph 0028, 0033) a sweetening composition comprising at least fructose and sucralose for use in foods including a wide variety of beverages. Inoue further teaches (Paragraph 0565, 0600) foods with an improved taste according to the invention include milky beverages such as milk for drinking, pasteurized milk, and milk beverage.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify Carrigan to include sucralose in the composition as taught by Inoue since both are directed to beverage products, including milk, that may contain additional sweeteners, since adding sucralose to a milk based beverage is known in the art as shown by Inoue, since, among the high sweeteners, sucralose, which is 600 times sweeter than sucrose, is non-carcinogenic and non-metabolize, i.e., having no calorie (Inoue, Paragraph 0004), since combined use of sucralose and fructose can significantly improve the lack of full-bodied and rich sweetness and provide a sweetening composition having high sweetness, good sweetness quality with a body, richness and the advantageous properties of fructose such as resistance to crystallizing and high water retentiveness (Inoue, Paragraph 0027), and since the features of the human gustory sense make fructose taste rich and sweet when it is together with sucralose in the oral cavity (Inoue, Paragraph 0029) thus providing a sweeter, more flavorful beverage that some consumers will prefer.
Response to Arguments
Applicant’s arguments, see pages 3-5, filed 02/06/2026, with respect to the rejection(s) of claim(s) 1 under 35 U.S.C. 103 have been fully considered and but are not persuasive.
Regarding the Applicant’s argument that a person of ordinary skill in the art reading Carrigan as a whole would not be motivated to add an additional sweetener to the lactose-hydrolyzed milk of Carrigan since Carrigan teaches that the lactose hydrolyzed milk can be reformulated by dilution to reduce the sweetness of the lactose-hydrolyzed milk, the desired "final milk product will maintain the organoleptic qualities with an acceptable level of sweetness and mouthfeel similar to or substantially the same to those of lactose containing milk, the Examiner notes that, while the dilution step may lower sweetness relative to the composition prior to dilution, this does not remove motivation for adding additional sweeteners. As stated in the rejection above, Carrigan teaches (Paragraph 0087) the product may comprise ingredients selected from a list including sugars and sweeteners. Furthermore, maintaining an acceptable level of sweetness and mouthfeel similar to or substantially the same to those of lactose containing milk is merely one embodiment of Carrigan, and not an explicitly requirement. Carrigan also teaches (Paragraph 0094) the reduced lactose or lactose free milk may have no additional sweetness, or may have a higher relative sweetness such as is desirable from a sensory perspective depending on national preferences. Thus, the inclusion of additional sweeteners would be obvious to one of ordinary skill in the art for the reasons stated above with regard to claim 1.
In response to the Applicant’s argument that the compositions of the present claims exhibit unexpected results since Test 2 in the Applicant’s Specification containing 4% sugar, lactase, and a flavor comprising glucosylated steviol glycoside (GSG) unexpectedly exhibited sweetness, sourness, cultured, and creamy sensory properties that were substantially equivalent to those of the Target product containing 7% sugar, which is unexpected because, while a person of ordinary skill in the art might have anticipated an increase in perceived sweetness from the addition of GSG, there would have been no reasonable expectation that the particular claimed combination with a reduced sugar level would replicate the full sensory profile of the higher-sugar Target, including the non-sweet attributes of sourness, cultured character, and creaminess, the Examiner maintains that the claimed invention fails to demonstrate unexpected results. The claimed dairy composition is broader in scope and does not claim the composition in the Test 2 example of the Applicant’s Specification comprising 4% sugar, lactase, and a flavor comprising glucosylated steviol glycoside (GSG). Unexpected results cannot be demonstrated when the claimed composition lacks the specific components and amounts used in the example. Furthermore, it is unclear how the parameters “sweetness, sourness, cultured, and creamy sensory properties” are objectively quantified, such that the unexpected results can be objectively evaluated.
Regarding the Applicant’s argument that the cited references are silent regarding water activity and provide no teaching or suggestion for controlling water activity in reduced-sugar dairy compositions, where low water activity is critical in dairy products because it limits microbial growth, enhances shelf life, stabilizes texture, and preserves balanced sensory properties and increased free water can negatively affect safety, stability, and flavor, making successful control of water activity a significant technical achievement, the Examiner notes that the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). The claimed product is obvious in view of Carrigan, as modified above, and, therefore, the claimed features of a lower water activity and an increased sweetness compared to a comparable composition lacking the lactose hydrolysis products and the glucosylated natural steviol glycosides would necessarily be present. Since the prior art teaches the claimed composition, it would be expected to perform in a similar manner.
Therefore, for the reasons stated above, claim 1, and all dependent claims remain rejected under 35 USC 103.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AUSTIN P TAYLOR whose telephone number is (571)272-2652. The examiner can normally be reached M-F 8:30am-5pm.
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, Erik Kashnikow can be reached at (571) 270-3475. 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.
/AUSTIN PARKER TAYLOR/Examiner, Art Unit 1792
/VIREN A THAKUR/Primary Examiner, Art Unit 1792