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 07/23/2026, the claims were amended. Based on these amendments, rejections under 35 U.S.C. 112 have been withdrawn and revised rejections under 35 U.S.C. 103 can be found below.
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 and 3-7 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 consists of 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 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 consists of 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).
Claims 2 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over McCormick (US 2020/0120947 A1), as evidenced by Schlievert (“Glycerol Monolaurate contributes to the Antimicrobial and Anti-inflammatory Activity of Human Milk”).
Regarding claim 2, McCormick teaches the limitations of claim 1. Specifically, a method for reducing the amount of a substrate in a sample (dairy products having reduced carbohydrates Abstract)
said method comprising the steps of: a. providing microbial cells comprising at least one intracellular enzyme for catalyzing conversion of said substrate into one or more products (fermentation with lactic acid bacteria Par. 0139; lactase may be intracellular Par. 0175)
b. incubating said microbial cells with a single permeabilizing agent, wherein said permeabilizing agent consists of a monoglyceride (initial fermentation material can be milk Par. 0098; fermentation Par. 0139). As evidenced by Schlievert, bovine milk is known to contain glycerol monolaurate (monolaurin) (Abstract), so the incubation with milk inherently is incubating with a monoglyceride. Further, as no permeabilizing agents are taught by McCormick, there is no other taught permeabilizing agent.
c. optionally harvesting permeabilized cells obtained in step (b). This limitation is optional so not required.
Regarding step d. incubating permeabilized cells obtained in step (b) or harvested cells obtained in step (c) with said sample comprising said substrate and wherein steps (a) and (b), and optionally step (c), are carried out prior to step (d), it has been found that the mere duplication of parts, without any new or unexpected results, is within the ambit of one of ordinary skill in the art. See In re Harza, 124 USPQ 378 (CCPA 1960) (see MPEP § 2144.04). It would have been obvious to repeat the incubating step b and treating monolaurin as the permeabilizing agent, the other components of milk are considered the sample. One would have been motivated to repeat this step for a more fermented product with further reduced carbohydrates.
Regarding wherein said microbial cells are susceptible to permeabilization by said permeabilizing agent, and wherein said permeabilization facilitates enhanced import of the substrate by the permeabilized cells compared to non-treated cells. As McCormick teaches the same microbial cells (streptococcus thermophilus, Lactobacillus casei Par. 0145), as well as the same permeabilizing agent (monolaurin, see above) as the present invention, one having ordinary skill in the art would expect the permeabilizing agent of McCormick to have similar permeabilizing ability to that of the present invention.
McCormick also teaches the limitations of claim 2. Specifically, the addition of monolaurin or monomystirate (initial fermentation material can be milk Par. 0098; fermentation Par. 0139). As evidenced by Schlievert, bovine milk is known to contain glycerol monolaurate (monolaurin) (Abstract), so the incubation with milk inherently is incubating with monolaurin.
Regarding claim 21, McCormick teaches the addition of monolaurin (initial fermentation material can be milk Par. 0098; fermentation Par. 0139). As evidenced by Schlievert, bovine milk is known to contain glycerol monolaurate (monolaurin) (Abstract), so the incubation with milk inherently is incubating with monolaurin.
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 2010/0285175 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 microorganism are permeabilized using a second permeabilizing agent prior to incubating in step (d), wherein said second permeabilizing agent consists of 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 microorganism is permeabilized using a second permeabilization agent prior to incubating in step (d).
Buthe teaches a dairy product is combined with (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 microorganism 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, see Pg. 9-10 of specification filed 07/23/2026, with respect to the rejection of claim 21 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of McCormick as evidenced by Schlievert, see above.
Applicant's arguments filed 07/23/2026 have been fully considered but they are not persuasive.
Applicant argues that Ruch teaches a preference for ethanol. Ruch uses of ethanol in a specific example, but ethanol is not limiting. Though ethanol appears to be preferentially selected as a solvent permeabilizing agent, Ruch discloses that the agent may be a chemical, solvent or detergent (Col. 2 lines 22-26) and gives no preference for which of these are used as the permeabilizing agent. Therefore, one would have applied a chemical or detergent permeabilizing agent with reasonable expectation of success.
Applicant argues that Galer teaches monoglycerides as secondary antimicrobial agents in combination with a bacteriocin and therefore does not teach monoglycerides as a sole permeabilizing agent. While it is important that Galer does teach monoglycerides as secondary agents, therefore additional permeabilizing agents (Col. 6 lines 27-46), Ruch specifically teaches that an agent is sufficient for permeabilization (Col 1 line 61-Col. 2 line 35) and one of Ruch’s categories for permeabilizing agents would include monoglycerides (chemicals Col. 2 lines 22-26). As noted in applicant’s arguments, Ruch and Galer are not performing the same exact processes and as such it would not be unreasonable for one having ordinary skill to select an antimicrobial agent from Galer’s taught antimicrobial agents and secondary antimicrobial agents as the agent for Ruch. Galer teaches monoglycerides as an antimicrobial agent and therefore one would have been motivated to use the monoglyceride of Galer in the invention of Ruch for the purpose of applying the antimicrobial properties. The invention of Galer does not suggest that the use of monoglyceride without a bacteriocin would void its antibacterial properties and therefore one would have expected to receive this benefit from the sole use of a monoglyceride.
Applicant further argues that Galer does not specifically attribute permeabilizing ability to monoglycerides. Galer broadly discloses the antimicrobial agents have cell-permeabilizing capabilities (Col. 5 lines 48-58), and this would reasonably include the secondary antimicrobial agents as well. Further, as the present invention teaches monoglycerides as acceptable permeabilizing agents, one would expect the monoglycerides of Galer to have similar permeabilizing properties when applied to Ruch.
In response to applicant's argument that Ruch and Galer is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Ruch concerns hydrolysis of dairy using bacteria to produce dairy products, while Galer concerns fermentation of a dairy product to produce a flavor component for food. Both inventions are centered around bacterial processing of dairy and therefore one would have been motivated to apply aspects of Galer to Ruch.
Applicant argues, with respect to claims 1 and 2, the data in Example 4 of the specification filed 10/20/2022 shows that the monolaurin of the present invention shows improved results over the primary reference, Ruch. For an effective rebut to a prima facie case of obviousness, applicant must compare the claimed subject matter with the closest prior art. In this case, what is claimed in claim 1 is the permeabilizing agent consists of a monoglyceride and claim 2 claims the permeabilizing agent is monolaurin or monomyristate, while the data is for specifically monolaurin. The improved results due to monolaurin cannot be assumed to be true of all monoglycerides (or even monomysristate), just monolaurin. Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." See MPEP 716.02(d-e). Further, Ruch uses ethanol in a specific example, but this is merely one embodiment of Ruch and a non-limiting embodiment considering Ruch also teaches that the agent may be a chemical or detergent (Col. 2 lines 22-26).
Applicant argues in regards to the rejections of claims 8-9 further in view of Hendricksen, that Hendrickson discloses a process in which enzymatic and fermentation processing are performed essentially at the same time. The combination of Ruch and Galer already teaches the enzymatic treatment and therefore Hendrickson is merely relied on for the aspect that it is known in the art to culture a milk product with yogurt cultures. As the milk of modified Ruch is already processed one would see the enzymatic processing of Hendricksen as optional. Further, the method of the present invention does not discount enzymes being present during the yogurt fermentation steps.
Applicant further argues in regards to the rejections of claims 10 and 14-15 further in view of Buthe, that Buthe does not disclose enzyme-containing microbial cells. Buthe is not relied on for the aspect of enzyme-containing microbial cells. 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.
Regarding a second microorganism or second permeabilizing agent, Ruch does not require solely one microcarrier. One would have been motivated to apply the enzyme of Buthe to the microcarrier of Ruch to have the benefits of both enzymes. Further, as the second microorganism appears to be incubated separately from the first microbial cells, the use of the monoglyceride of Galer would be considered a second permeabilizing agent.
Regarding applicant’s argument that the enzymes of Buthe require specific process conditions to be effective, it is well within the skill of one having ordinary skill in the art to look to the art and/or use routine experimentation to optimize the process conditions for the intracellular enzymes to perform.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Ludwig (US 2016/0278414 A1) teaches fermentation of milk (Par. 0046) using streptococcus thermophilus having beta-galactosidase over the course of fermentation (Par. 0051).
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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/A.M.R./Examiner, Art Unit 1792
/ERIK KASHNIKOW/Supervisory Patent Examiner, Art Unit 1792
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