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
Claims 1-8 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 12/01/2025.
Applicant's election with traverse of Group II, claims 9-16 in the reply filed on 12/01/2025 is acknowledged. The traversal is on the ground(s) that there is no excessive burden to the examiner to search. Applicant argues that the same search would be performed whether or not a restriction requirement was issued. This is not found persuasive because the search burden is significant as well as the burden on examination. Note that claims 1-8 do not have the same limitations and art that may be applied to claims 1-8 may not be considered applicable to claims 9-16 due to their differences. While there may be common generalities, these generalities alter the examination burden as to the search as well as the recognized divergent subject matter (product versus process) require significantly different considerations.
As it stands, claim 1 does not require any of the material limitations in combination that are commensurate with claim 9 and also may be made by a materially different process as far as the homogenization, cooling, etc. Thus, a search for claims 1-8 would require a broad extension of any search performed for claims 9-16 as well as additional consideration of product limitations as opposed to method limitations.
The requirement is still deemed proper and is therefore made FINAL.
Claim Objections
Claims 9 and 15 are objected to because of the following informalities: In claim 9, the phrase “a cold conditions” should have “a” removed. Claim 15 should end in a period (.), not a semicolon. Appropriate correction is required.
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 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.
Claim 9 recites dependency to a withdrawn claim (claim 8).
Claim 9 recites “the soluble prebiotic dietary fiber” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites “the suspension of probiotic cells” in line 3. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 9, the phrase "such as" in reference to “carnauba wax” 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 9 states “homogenizing the resulting oil and water phases in two stages”. It is not clear if the oil and water phases are in reference to the oleogel and hydrogel, respectively. The reference to “two stages” is not clear with regard to which steps are considered the first and second steps.
Claim 9 refers to “the temperature appropriate for probiotic cells”. This limitation is unclear as the term “appropriate” is undefined.
Claim 9 recites “the pre-prepared probiotic cell suspension”. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites “the ice back”. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 refers to “The method of claim 8”. It appears that this should be –claim 9--.
Claim 10 uses the phrase “well-ventilated”. The term “well-ventilated” in claim 10 is a relative term which renders the claim indefinite. The term “well-ventilated” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is suggested to remove “well” or provide a clear indication of the qualification or quantification of “well”.
Claim 10 refers to “powders” but it is not clear what powders are referenced.
Claim 10 recites “the separated water soluble fraction”. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites “the sediments”. There is insufficient antecedent basis for this limitation in the claim.
Claim 12 recites “the probiotic strains”. There is insufficient antecedent basis for this limitation in the claim.
Claims 13-16 state “is performed under the following preferred conditions”. The use of the term “preferred” renders the claims indefinite as it is not clear if the particulars of the claims are positively required or if only broad limitations are required. Removal of the term “preferred” is suggested. For examination, the claims have been treated as if the limitations are positively required.
In claims 13 and 14, the amounts are not clear. Does 60g/100g mean that the hydrogel is 60wt% collagen based on a total of the components present in the hydrogel? Likewise, is the hydrogel 1.34wt% soluble dietary fiber? For the carnauba was, is the oleogel 9wt% carnauba wax based on the total of oil and carnauba wax?
In claim 15, is the addition of 1ml/100g the total added or is it the amount that may be added incrementally?
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, and 13-16 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 carnuba 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 synbiotics 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. As noted above, the amounts as claimed are not entirely clear inasmuch as the formation of the hydrogel and oleogel with probiotics. 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 (if that is the meaning of 9g/100g) 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 15, Baltuonyte discloses mixing at a ratio of 40:60 (hydrogel to oleogel) rather than 75:25 as claimed (as best understood, the “oil and water phases” is taken as water is hydrogel and oil is oleogel). “[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 to provide thorough homogenization is seen to be within the purview of one of ordinary skill in the art.
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 and 12 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).
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.
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 that can be used in a food product such as a bigel.
Conclusion
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 1793
/Jennifer McNeil/ Primary Examiner, Art Unit 1793