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 .
Claim Objections
Claim 1 is objected to because of the following informalities: the preamble recites “prebiotic soluble dietary fibers”. The claims refer to “soluble prebiotic dietary fibers”. For consistency, it is recommended to change the preamble of claim 1 to “soluble prebiotic dietary fibers”. The preamble also refers to “probiotics” whereas the rest of the claims refer to “probiotic cells”. For consistency, it is recommended to change the preamble to “probiotic cells”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 9-14, and 16 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 9 was amended to require “cooling down the homogenized mixture to 55C or below rather than state “the temperature appropriate for probiotic cells”. The instant specification did not provide a definition of “appropriate” such that one of ordinary skill would reasonably interpret this limitation from the original claims to encompass any temperature below 55C. The specification does not appear to use the phrase “appropriate temperature” such that the original limitation can be clearly understood as to its scope. The instant specification appears to disclose cooling “until 55C” which is consistent with the limitation of claim 15. However, there does not appear to be any support for cooling to “55C or below” such that any temperature below 55C is within the scope of the claim.
Claim 15 is not included since the claim requires the same cooling step disclosed in the instant specification.
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 9-16 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 phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Claim 1 recites “such as carnauba wax” in line 7.
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 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.
Claim(s) 9, 10, 13, 14, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over “Novel Formulation of Bigel-Based Vegetable Oil Spreads Enriched with Lingonberry Pomace”, Foods, 07/25/2022 (Baltuonyte) in view of “Mechanical properties and delivery of drug/probiotics from starch and non-starch based novel bigels: A comparative study”, (Behera) (cited on IDS filed 08/08/2023) and “Functional activity of commercial prebiotics”, (Huebner) (cited on IDS filed 08/08/2023).
Regarding claim 9, Baltuonyte discloses a bigel vegetable oil spread with lingonberry pomace (soluble dietary fiber) (page 2). To prepare the oil phase (oleogel), sunflower and carnauba wax are used. To prepare the hydrogel phase, collagen and distilled water is used to dissolve the collagen (page 2). The hydrogel is “incubated” at 85C in a water bath for 30 mins. The pomace is added to the hydrogel and oleogel (page 2) but Balyonyte does not disclose adding the pomace and incubating with the collagen. However, this appears to be an obvious change to the order of steps and it would have been obvious to add the pomace at any point in the formation of the hydrogel or oleogel (See In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946) (selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results); In re Gibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930) (Selection of any order of mixing ingredients is prima facie obvious.) (MPEP 2144.04). After the hydrogel, oleogel and pomace are combined, the mixture is homogenized. Subsequently, the samples are added to icy water and kept until full solidification and later the samples were stored in a refrigerator for 24 hours (paragraph bridging pages 2-3).
Baltuonyte does not disclose the addition of probiotics to the spreadable bigel but does recognize that bigels have been uses as probiotic delivery systems (Introduction). Moreover, it is known that bigels can be used effectively for delivery of probiotics (Behera, abstract, section 2.4.5). Prebiotics are known to support selective growth of lactobacilli (probiotic), in particular inulin and L. paracasei, as recognized by Huebner. While Baltuonyte does not expressly disclose the presence of a probiotic in the method of making a bigel, Baltuonyte does recognize that bigels are useful for delivery of probiotics. With the disclosure by Huebner that prebiotics provide support for probiotics (symbiosis), it would have been obvious to one of ordinary skill to provide the bigel of Baltuonyte with a probiotic to gain the benefits of the interaction with the prebiotic (berry pomace) as well as the health benefits gained by symbiotics which are recognized as having the ability to influence and improve the gastrointestinal health of humans (Huebner, Introduction, page 1).
Regarding claim 10, Baltuonyte discloses forming the pomace by pressing lingonberries to form a residue or pomace. This pomace was dried at 35-38C in a drying chamber for 48 hours and ground using a 0.5mm sieve. This treatment step is commensurate with hot air (drying chamber) of 35-40C for 48 hours. It is noted that Baltuonyte discloses a moisture content of 3.41% which does not overlap with the 7-9% claimed. However, the amount of moisture is not seen to provide a patentably distinct method with regard to the pomace formation as one of ordinary skill in the art would recognize that moistures levels reached with a similar method of drying would result in a dried product suitable for use, absent some showing that the moisture content has some criticality. The limitations following the phrase “optionally” are seen to be optional.
Regarding claims 13 and 14, Baltuonyte discloses mixing collagen in the distilled water, holding at 85C for 30 mins to form the hydrogel. To form the oleogel, carnauba was is mixed with a mixture of sunflower oil and olive pomace oil and agitated at 85C until complete solubilization (2.1, 2.2.1). It would have been obvious to one of ordinary skill to determine the relative amounts to be added together to form the bigel. Moreover, “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)” (MPEP 2144.05). Here, one of ordinary skill in the art would have found it obvious to vary the amounts of collagen and fiber to determine the optimum concentrations by routine experimentation. Additionally, increasing the fiber or decreasing the fiber as well as the probiotic are seen to be readily determined based upon the desired prebiotic and probiotic amounts in the finally formed product. Regarding the carnauba wax, it appears that Baltuonyte discloses 10% by weight which is so close to 9% by weight as to not indicate a patentable distinction. Baltuonyte does not expressly disclose continuous mixing for the hydrogel, but does disclose agitation for the oleogel. One of ordinary skill would have found it obvious to mix the hydrogel to prevent any settling prior to combination with the oleogel in a similar manner to that of agitation of the oleogel.
Regarding claim 16, Baltuonyte discloses placing the samples in icy water until full solidification, which is considered gelation of both phases (2.2.1).
Claim(s) 11, 12, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over “Novel Formulation of Bigel-Based Vegetable Oil Spreads Enriched with Lingonberry Pomace”, Foods, 07/25/2022 (Baltuonyte) in view of “Mechanical properties and delivery of drug/probiotics from starch and non-starch based novel bigels: A comparative study”, Behera (cited on IDS filed 08/08/2023) and “Functional activity of commercial prebiotics”, Huebner (cited on IDS filed 08/08/2023) and further in view of “Bigel formulations based on sesame oleogel with probiotics alginate hydrogel: A novel structure for nutritious spreadable butter”, International Journal of Biological Macromolecules (05/09/2023) (Hashim) and “The Effect of Encapsulating a Prebiotic-Based Biopolymer Delivery System for Enhanced Probiotic Survival”, Polymers, 03/31/2023 (Kistaubayeva) and US 2009/0208606 (Hakansson).
Note that claim 15 is rejected here rather than in the rejection above due to the amendment to the claim amendment requiring the count of viable cells in the suspension of probiotic cells.
Baltuonyte in view of Behera and Huebner do not disclose how the probiotic is formed. Hashim discloses a bigel (combination of oleogel and hydrogel) to form a spreadable butter wherein the Lactobacillus probiotic is prepared by activating using MRS broth and incubating at 37C for 48hrs anaerobically and after incubation the cells were centrifuged at 6000rpm for 20 minutes at 4C. Finally, the cells were washed with saline solution. It would have been obvious to provide sterile saline to avoid any contamination. Regarding the anaerobic versus aerobic, it would have been obvious to one of ordinary skill to incubate in either environment absent a showing of unexpected results.
Moreover, Kistaubayeva discloses preparation of a lactobacillus strain by incubating in MRS medium at 37C for 48 hours to obtain 1010 CFU/ml, centrifuging the cells and washing with saline solution (2.1). One of ordinary skill would that the process was performed aerobically since there is no express requirement for an anaerobic environment for incubation. Thus, one of ordinary skill would have reasonably been appraised that cultivation could be done aerobically or anaerobically.
Regarding the differences in time (22 hours instead of 48hrs and 10 minutes instead of 20 minutes), these differences are not considered to confer any patentable distinction to the method as the parameters are readily optimizable by one of ordinary skill in the art to determine the workable ranges. Moreover, Kistaubayeva discloses centrifuging for 15 minutes which is indicative of the variability of time.
Further illustrative of the variability of parameters for preparing a probiotic such as Lactobacillus, Hakansson discloses preparation of Lactobacillus strains using MRS, incubating for 20 hours at 37C in an anaerobic environment, followed by centrifuging and washing with saline [0086]. Hakansson also discloses 109-1011 CFU/ml [0089]. It would have been obvious to one of ordinary skill in the art to optimize the preparation of a probiotic for addition to Baltuonyte as modified by Behera and Huebner, thus obtaining the desired probiotic for addition to a food spread and gain the benefits of the interaction with the prebiotic. The parameters of preparation are disclosed as variable and well-within the level of one of ordinary skill to optimize and determine workable ranges, as well as optimize to obtain an optimal amount of viable cells.
Further regarding claim 15, Baltuonyte discloses mixing at a ratio of 40:60 (hydrogel to oleogel) rather than 75:25 as claimed. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)” (MPEP 2144.05). Here, the relative amounts of the hydrogel and oleogel are seen to be optimizable to affect the spreadability of the finally formed product. Regarding the process parameters, homogenization of the mixture is performed for 2 minutes at 15000rpm at 85C. The difference of 60 seconds versus 2 minutes is not seen to impart a patentable distinction and increasing the time or splitting into multiple steps to provide thorough homogenization is seen to be within the purview of one of ordinary skill in the art.
Claim 10 is alternatively rejected under 35 U.S.C. 103 as being unpatentable over “Novel Formulation of Bigel-Based Vegetable Oil Spreads Enriched with Lingonberry Pomace”, Foods, 07/25/2022 (Baltuonyte) in view of “Mechanical properties and delivery of drug/probiotics from starch and non-starch based novel bigels: A comparative study”, Behera (cited on IDS filed 08/08/2023) and “Functional activity of commercial prebiotics”, Huebner (cited on IDS filed 08/08/2023) in view of US 2024/0407409 (Leskauskaite) (filing date 06/09/2023)
Leskauskaite discloses formation of a bigel for use in making high-protein and prebiotic fiber-rich food.
Regarding claim 10, preparing prebiotic dietary fibers is performed by providing fresh or defrosted berry pomace which is dried to a moisture content of 7-9% by using various drying methods—hot air (35-40° C., 48-72 hours), freeze-drying (−50° C., 0.5 mbar, 24-48 hours). [0091]. The dried pomace is cooled, weighed, and stored in sealed packages in a well-ventilated room with a relative humidity of no higher than 75% and an ambient temperature not exceeding 20° C. up to 4 months, or refrigerated at 4° C. up to 12 months. Before usage dry pomace is milled to 0.2-0.25 mm particles. The limitations following “optionally” are considered optional. It would have been obvious to one of ordinary skill to prepare the prebiotic dietary fibers of Baltuonyte in the manner disclosed by Leskauskaite with a reasonable expectation of successfully forming berry pomace preparation that can be used in a food product such as a bigel.
Response to Arguments
Applicant’s amendments have overcome the 112(b) rejections but for the “such as” issue as identified above.
Applicant’s amendment to claim 9 regarding the temperature 55C necessitated the new ground of rejection under 112(a).
Applicant's arguments filed 05/12/2026 regarding the art rejections under 103 have been fully considered but they are not persuasive.
Applicant argues that Baltuonyte clearly indicates that the lingonberry pomace contained total insoluble dietary fibers at 65.36% and total soluble dietary fiber at 8.49%, thus by no means the pomace of Baltuonyte was soluble dietary fiber. Claim 9 requires preparing the soluble prebiotic dietary fibers from berry pomace. There is no requirement for the particular amount of soluble prebiotic dietary fiber in the step of preparing recited in the claim. The preparation of Baltuonyte contains soluble dietary fiber, thus soluble dietary fiber is considered to be present and prepared and then added to the hydrogel and oleogel. The resulting bigel contains hydrogel phase of soluble prebiotic dietary fibers from berry pomace and an oleogel phase.
Applicant argues that paragraph [0014] of the instant application notes that currently there is no evidence of prebiotic activity of water-soluble dietary fibers extracted from berry-pomace. The claim does not require a degree of prebiotic activity or a concentration of fibers present in the bigel. The claim requires the presence of soluble prebiotic dietary fibers. The term “prebiotic” is not seen to require a particular amount of activity or concentration of the fibers.
Applicant separately addresses claims 10, 11 and 12, but the arguments are cumulative.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER C MCNEIL whose telephone number is (571)272-1540. The examiner can normally be reached M-F 9-5.
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JENNIFER C. MCNEIL
Primary Examiner
Art Unit 1723
/Jennifer McNeil/Primary Examiner, Art Unit 1723
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