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 .
Response to Amendment
In applicant’s reply on 12/22/2025, the claims were amended and new claims were added. Based on these amendments, revised rejections under 35 U.S.C. 112 and 103 can be found below as well as rejections of new claims.
Claim Objections
Withdrawn claim 23 is objected to because of the following informalities: It appears claim 22 was repeated rather than reciting 22 and 23. Appropriate correction is recommended.
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.
Claim 10 is 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 10 recites the limitation "said cells of the second microbial cell”, but there is no prior mention of a second microbial cell. It appears this is referencing the “cells of a second microorganism” earlier mentioned in claim 10. If this is the case, "said cells of the second microbial cell” should be amended to read "said cells of the second microorganism” for continuity and to improve clarity.
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.
Claims 1-7, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Ruch (US 6,833,260 B1), in view of Galer (US 8,703,217 B2).
Regarding Claim 1, Ruch teaches a method for reducing the amount of a substrate in a sample (hydrolyzing lactose Abstract)
a. providing microbial cells comprising at least one intracellular enzyme for catalyzing conversion of said substrate into one or more products (lactase microcarrier, transforming food grade lactic acid bacterium to exhibit beta-galactosidase activity Col. 1 line 61-Col. 2 line 5; lactose hydrolyzed to glucose and galactose Col. 1 lines 15-17; Fig. 1 shows intracellular enzyme)
b. incubating said microbial cells with a single permeabilizing agent (permeabilized by an agent Col 1 line 61-Col. 2 line 35; incubating at room temperature for 25 minutes Col. 12 lines 6-21)
c. optionally harvesting permeabilized cells obtained in step (b) (cells were pelleted, washed, and resuspended Col. 12 lines 6-21)
d. incubating permeabilized cells obtained in step (b) or harvested cells obtained in step (c) with said sample comprising said substrate (hydrolysis of lactose by permeabilized lactic acid bacteria, incubated at 55 degree C Col.9 lines 14-33)
wherein said microbial cells are susceptible to permeabilization by said permeabilizing agent (membranes of lactic acid bacteria can be permeabilized by chemicals such as detergents or solvents Col. 9 lines 1-14)
wherein steps (a) and (b), are carried out prior to step (d) (Fig. 1)
and wherein said permeabilization facilitates enhanced import of the substrate by the permeabilized cells compared to non-treated cells (permeabilization to facilitate lactose hydrolysis Col. 12 lines 1-2)
Ruch does not teach the permeabilizing agent is a monoglyceride.
Galer, in the same field of endeavor, teaches incubating microbial cells with a monoglyceride (secondary antimicrobial agent such as monoglycerides Col. 6 lines 27-46)
It would have been obvious to one having ordinary skill in the art, at the time of filing, to apply the monoglyceride of Galer to the invention of Ruch. Galer teaches the use of monoglyceride for its antimicrobial properties (Col. 6 lines 27-46). As such, the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. See MPEP 2144.07.
Regarding Claim 2, Ruch does not teach the permeabilizing agent is selected from the group consisting of: monolaurin and monomyristate.
Galer, in the same field of endeavor, teaches incubating microbial cells with monolaurin (secondary antimicrobial agent such as monolaurin Col. 6 lines 27-46)
It would have been obvious to one having ordinary skill in the art, at the time of filing, to apply the monolaurin of Galer to the invention of Ruch. Galer teaches the use of monolaurin for its antimicrobial properties (Col. 6 lines 27-46). As such, it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose. See MPEP 2144.06.I.
Regarding Claim 3, Ruch further teaches wherein said microbial cells provided in step (a) are bacteria selected from the group consisting of: Escherichia, Streptococcus, Lactobacillus, Lactococcus, Lactovum, Pediococcus, Leuconostoc, Fructobacillus, Weissella, Oenococcus, Corynebacterium, Brevibacterium, Bacillus, Sporolactobacillus, Geobacillus, Halobacillus, Halolactibacillus, Tetragenococcus, Acetobacter, Acinetobacter, Proprionibacterium, and Bifidobacterium (The lactic acid bacterium can be a Streptococcus, Aerococcus, Carnobacterium, Enteroccus, Erysipelothrix, Gemella, Globicatella, Lactobacillus, Lactococcus, Bidobacteria, Leuconostoccocus, Pediococcus, Streptococcus, Tetragenococcus, or Bagococcus bacteria Col. 2 lines 8-13).
Regarding Claim 4, Ruch further teaches the sample is a food or beverage (milk Col. 9 lines 14-33).
Regarding Claim 5, Ruch teaches wherein the method is for reducing lactose content of a dairy product (hydrolyze lactose in skim milk Col. 9 lines 14-33)
a. providing cells of a lactic acid bacterium comprising intracellular beta-galactosidase EC 3.2.1.23. for catalyzing conversion of lactose to galactose and glucose (lactase microcarrier, transforming food grade lactic acid bacterium to exhibit beta-galactosidase activity Col. 1 line 61-Col. 2 line 5; lactose hydrolyzed to glucose and galactose Col. 1 lines 15-17; Fig. 1 shows intracellular enzyme)
b. incubating said cells of (a) with a single permeabilizing agent (permeabilized by an agent Col 1 line 61-Col. 2 line 35; incubating at room temperature for 25 minutes Col. 12 lines 6-21)
c. optionally harvesting permeabilized cells obtained in step (b) (cells were pelleted, washed, and resuspended Col. 12 lines 6-21)
d. incubating permeabilized cells obtained in step (b) or (c) with said dairy product, (hydrolysis of lactose by permeabilized lactic acid bacteria, hydrolyze lactose in skim milk when incubated at 55 degree C Col.9 lines 14-33)
wherein steps (a) and (b), and optionally step (c), are carried out prior to step (d). (Fig. 1).
Ruch does not teach wherein said permeabilizing agent is a monoglyceride
Galer, in the same field of endeavor, teaches incubating microbial cells with a monoglyceride (secondary antimicrobial agent such as monoglycerides Col. 6 lines 27-46)
It would have been obvious to one having ordinary skill in the art, at the time of filing, to apply the monoglyceride of Galer to the invention of Ruch. Galer teaches the use of monoglyceride for its antimicrobial properties (Col. 6 lines 27-46). As such, the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. See MPEP 2144.07.
Regarding Claim 6, Ruch further teaches the lactic acid bacterium is selected from the group consisting of: Streptococcus thermophilus, Lactobacillus casei, Lactobacillus plantarum, Lactobacillus helveticus, Lactobacillus delbrueckii, Lactobacillus acidophilus, and Lactococcus lactis (the lactic acid bacterium can be a Lactococcus lactis Col. 2 lines 8-13).
Regarding Claim 7, Ruch further teaches the dairy product is a milk product, selected from the group consisting of: skimmed milk, regular milk, whole milk, butter milk, cream, whey, butter, and yoghurt, or a yoghurt-like product selected from the group consisting of: junket, drink yoghurt, Skyr, Quark and Greek yoghurt (skim milk Col. 9 lines 14-33).
Regarding claim 21, Ruch does not teach the permeabilizing agent is monolaurin.
Galer, in the same field of endeavor, teaches incubating microbial cells with monolaurin (secondary antimicrobial agent such as monolaurin Col. 6 lines 27-46).
It would have been obvious to one having ordinary skill in the art, at the time of filing, to apply the monolaurin of Galer to the invention of Ruch. Galer teaches the use of monolaurin for its antimicrobial properties (Col. 6 lines 27-46). As such, it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose. See MPEP 2144.06.I.
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Ruch in view of Galer, further in view of Hendriksen (US 20100285175 A1).
Regarding Claim 8, modified Ruch teaches the limitations of claim 5 above.
Ruch teaches the permeabilized cells are harvested in step (c) (cells were pelleted, washed, and resuspended Col. 12 lines 6-21)
the dairy product in step (d) is milk (skim milk Col.9 lines 14-33)
Ruch does not teach culturing cells of a yoghurt starter bacterium in the product obtained in step (d).
Galer does not teach p of: e. culturing cells of a yoghurt starter bacterium in the product obtained in step (d).
Hendriksen, in the same field of endeavor, teaches culturing cells of a yoghurt starter bacterium in milk (fermented milk product including yoghurt, using a bacterium capable of fermenting milk substrate Par. 76-79).
It would have been obvious, at the time of filing, to modify the invention of modified Ruch with the yoghurt fermentation of Hendriksen. One would have been motivated to make this modification to produce a low lactose yoghurt (Hendriksen Par. 0008).
Regarding Claim 9, modified Ruch does not teach the yoghurt starter bacterium is Streptococcus thermophilus or Lactobacillus delbruckii subsp. bulgaricus.
Hendriksen teaches the yoghurt starter bacterium is Streptococcus thermophilus or Lactobacillus delbruckii subsp. Bulgaricus (Streptococcus thermophilus, Lactobacillus delbrueckii subsp. bulgaricus Par. 0081).
It would have been obvious, at the time of filing, to modify the invention of modified Ruch with the yoghurt starter bacterium of Hendriksen. One would have been motivated to make this modification to produce a low lactose yoghurt (Hendriksen Par. 0008).
Claims 10 and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Ruch in view of Galer, further in view of Buthe (WO 2019/166514 A1).
Regarding Claim 10, modified Ruch teaches limitations of claim 5.
Ruch teaches incubating a dairy product with cells of a second microorganism comprising an enzyme (hydrolysis of lactose by permeabilized lactic acid bacteria, incubated at 55 degree C Col.9 lines 14-33, lactase microcarrier Col. 1 line 61-Col. 2 line 5)
and a microbial cell is permeabilized using a permeabilization agent (permeabilized by an agent Col 1 line 61-Col. 2 line 35; incubating at room temperature for 25 minutes Col. 12 lines 6-21)
Ruch does not teach said dairy product is additionally incubated with cells of a microorganism comprising (i) xylose isomerase EC 5.3.1.5 for conversion of glucose to fructose, and/or (ii) arabinose isomerase EC 5.3.1.4 for conversion of galactose to tagatose, and wherein said cells of the second microbial cell are permeabilized using a second permeabilizing agent prior to incubating in step (d), wherein said second permeabilizing agent is a monoglyceride.
Galer teaches incubating microbial cells with a monoglyceride (secondary antimicrobial agent such as monoglycerides Col. 6 lines 27-46).
Galer does not teach said dairy product is additionally incubated with cells of a microorganism comprising (i) xylose isomerase EC 5.3.1.5 for conversion of glucose to fructose, and/or (ii) arabinose isomerase EC 5.3.1.4 for conversion of galactose to tagatose, and wherein said second microbial cell is permeabilized using a second permeabilization agent prior to incubating in step (d).
Buthe teaches a dairy product is combined with cells (i) xylose isomerase EC 5.3.1.5 for conversion of glucose to fructose, and/or (ii) arabinose isomerase EC 5.3.1.4 for conversion of galactose to tagatose (the disaccharide lactose in liquid milk is in-situ hydrolyzed into its monosaccharides glucose and galactose by the use of enzymes named beta-galactosidase. If L-arabinose isomerase is in-situ applied in the virgin liquid nutrient, galactose is converted into D-tagatose Par. 160).
It would have been obvious to one having ordinary skill in the art to further modify modified Ruch with the enzyme of Buthe. One would have been motivated to make this modification to obtain a product rich in functional carbohydrates (Buthe Abstract).
Regarding a microorganism comprising xylose isomerase EC 5.3.1.5 and/or arabinose isomerase EC 5.3.1.4, and said second microbial cell is permeabilized using a second permeabilization agent prior to incubating in step (d), as seen above, Ruch teaches incubating a dairy product with cells of a microorganism comprising an enzyme (hydrolysis of lactose by permeabilized lactic acid bacteria, incubated at 55 degree C Col.9 lines 14-33, lactase microcarrier Col. 1 line 61-Col. 2 line 5), as well as use of a permeabilizing agent (permeabilized by an agent Col 1 line 61-Col. 2 line 35; incubating at room temperature for 25 minutes Col. 12 lines 6-21). It would therefore be obvious to one having ordinary skill in the art to apply the enzyme of Buthe to the methods of modified Ruch.
Regarding Claim 14, modified Ruch teaches the limitations of claim 1, but does not teach wherein the substrate is galactose, the intracellular enzyme is arabinose isomerase EC 5.3.1.4, and the one or more products comprises tagatose.
Buthe teaches wherein the substrate is galactose, the intracellular enzyme is arabinose isomerase EC 5.3.1.4, and the one or more products comprises tagatose (if L-arabinose isomerase is in-situ applied in the virgin liquid nutrient, galactose is converted into D-tagatose Par. 160).
It would have been obvious to one having ordinary skill in the art to further modify modified Ruch with the enzyme and substrate of Buthe. One would have been motivated to make this modification to obtain a product rich in functional carbohydrates (Buthe Abstract).
Regarding Claim 15, Ruch teaches the microbial cell is a lactic acid bacteria (transforming food grade lactic acid bacterium Col. 1 line 61-Col. 2 line 5)
Response to Arguments
Applicant's arguments filed 12/22/2025 have been fully considered but they are not persuasive.
Applicant argues that Ruch does not disclose a monoglyceride as its permeabilizing agent so it would not be obvious when combining with Galer for the monoglyceride to be the sole permeabilizing agent. Ruch teaches “permeabilized by an agent” (Col 1 line 61-Col. 2 line 35). The use of “an” signals a singular agent. When combined with Galer, one could reasonably use the monoglyceride of Galer as the agent in the invention of Ruch. And one would have been motivated to use the agent of Galer for its antimicrobial properties (Col. 6 lines 27-46, as seen above).
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). Specifically applicant argues the motivation that the monoglyceride of Galen provides antimicrobial properties is misplaced as monoglycerides are taught as a secondary antimicrobial. Galen’s use of a monoglyceride as a secondary antimicrobial agent does not mean that when used alone it completely lacks antimicrobial properties. It is still an antimicrobial agent and one would reasonably expect it to have antimicrobial properties when used alone. One could apply any of the antimicrobial agents of Galen, whether primary or secondary, and expect to benefit from the antimicrobial effects.
Applicant argues example 4 and figure 4 show the superiority of monolaurin compared to ethanol. As Galer teaches the use of monolaurin (secondary antimicrobial agent such as monolaurin Col. 6 lines 27-46), this showing does not distinguish the invention over the art.
Applicant argues Buthe teaches the use of external enzymes rather than within a cell. The primary reference, Ruch, teaches transforming a bacterium to produce an enzyme microcarrier (Col.9 lines 14-33, Col. 1 line 61-Col. 2 line 5, Fig. 1 seen above). Buthe is merely relied on to teach the specific enzyme. It would have been obvious to one having ordinary skill in the art to apply the enzyme of Buthe to the enzyme microcarrier of Ruch to achieve to the taught benefit of a product rich in functional carbohydrates (Buthe Abstract), with reasonable expectation of success.
Conclusion
THIS ACTION IS MADE FINAL. 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 ARIEL M RODGERS whose telephone number is (571)272-7857. The examiner can normally be reached Monday - Friday 9:00 am - 6:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Erik Kashnikow can be reached at 5712703475. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.M.R./Examiner, Art Unit 1792
/ERIK KASHNIKOW/Supervisory Patent Examiner, Art Unit 1792
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