DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The status of the claims stands as follows:
Pending claims: 1-18
Withdrawn claims: None
Claims currently under consideration: 1-18
Currently rejected claims: 1-18
Allowed claims: None
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Specification
This application does not contain an abstract of the disclosure as required by 37 CFR 1.72(b). An abstract on a separate sheet is required.
The disclosure is objected to because the tables in the examples contain values which use commas in place of decimal points (i.e., the table below line 27 on page 29 of the specification recites “3,1” instead of “3.1”).
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.
Claims 6-8 and 11-16 are rejected under 35 U.S.C. 112(b) 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 claims 6, 7, and 8, the parenthesis around the term “partially” renders the claim indefinite because it is unclear whether the limitation(s) within the parenthesis are part of the claimed invention. See MPEP § 2173.05(d). For the purpose of this examination, the claims will be interpreted as if the enzyme is purified to any degree.
Claim 11 recites “membrane (M2)”. The label “M2” implies that there is a first membrane present in the claimed method. However, claim 1, from which claim 11 depends, does not recite a first membrane. Therefore, it is unclear as to whether there is a first membrane so that the claim is indefinite. For the purpose of this examination, the membrane (M2) will be interpreted as being a second membrane, wherein a first membrane (M1) is used in any step prior to step (iii-2).
Claim 13 recites that steps (ii) and (iii-2) of the process are carried out via a single membrane (M1). However, claim 11, from which claim 13 depends, requires the membrane of step (iii-2) to be the membrane (M2). Therefore, it is unclear as to what membrane (M1) in claim 13 is meant to refer so that the claim is indefinite. For the purpose of this examination, claim 13 will be interpreted as if the membrane were not labeled (M1).
Claim 14 recites the limitation "the membrane (M1)" in lines 2 and 3. There is insufficient antecedent basis for this limitation in the claim. However, due to the interpretation of claim 11 stated above, wherein the membrane (M2) recited in claim 11 will be interpreted as being a second membrane, and wherein a first membrane (M1) is used in any step prior to step (iii-2), the lack of antecedent basis in claim 14 is considered to be resolved.
Claim 15 recites the pore size of the membrane. However, due to the aforementioned indefiniteness identified in claim 11 and the interpretation required to resolve the identified indefiniteness as being a membrane present prior to M2, it is unclear as to whether the pore size of the membrane recited in claim 15 refers to that of the first membrane and/or that of the second membrane. Therefore, claim 15 is indefinite. For the purpose of this examination, the pore size of the membrane will be interpreted as referring to that of the first membrane and/or second membrane.
Claim 16 recites that the transmembrane pressure. However, due to the aforementioned indefiniteness identified in claim 11 and the interpretation required to resolve the identified indefiniteness as being a membrane present prior to M2, it is unclear as to whether the transmembrane pressure of the membrane recited in claim 16 refers to that of the first membrane and/or that of the second membrane. Therefore, claim 16 is indefinite. For the purpose of this examination, the transmembrane pressure of the membrane will be interpreted as referring to that of the first membrane and/or second membrane.
Claims 17 and 18 are rejected by reason of dependency from claim 11.
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.
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, 9, and 11-18 are rejected under 35 U.S.C. 103 as being unpatentable over Ordóñez (WO 2021/123163) in view of Bedade (Bedade et al., “Chitosan coated calcium alginate beads for covalent immobilization of acrylamidase: Process parameters and removal of acrylamide from coffee”, 2019, Food Chemistry, 275, pages 95-104).
Regarding claim 1, Ordóñez teaches a method for removing acrylamide from an aqueous preparation (corresponding to low aromatic aqueous coffee extract having a first acrylamide content) to produce a final product having a reduced acrylamide content (corresponding to a low aromatic aqueous coffee extract having an acrylamide content lower than the first acrylamide content) (page 3, line 28 – page 4, line 45). Ordóñez teaches that the method comprises: (i) providing an aqueous preparation containing acrylamide and other components (corresponding to components such as organic acids) as a starting product for the production of a final product with a reduced acrylamide content (page 8, lines 34-35; page 15, lines 5-7). Ordóñez teaches that the method then comprises: (ii) dividing the aqueous preparation into two material streams to obtain a retentate (R1) and a permeate (P1), wherein R1 contains other components (K1), and wherein the P1 contains acrylamide (page 13, line 24-25; page 14, lines 22-32). Ordóñez teaches that the permeate is combined with a high aromatic aqueous coffee extract to provide a liquid coffee concentrate (page 8, lines 22-25).
Ordóñez does not teach steps (iii)-(v) of the presently claimed method.
However, Bedade teaches a method for converting acrylamide from an aqueous preparation (corresponding to coffee) to produce a final product having a reduced acrylamide content (page 100, 2nd column, section 3.7.1 – page 101, 1st column, 1st paragraph). Bedade teaches that the method comprises: contacting the aqueous preparation with an acrylamide-reducing biocatalyst (corresponding to acrylamidase), thereby obtaining an aqueous preparation with a reduced content of acrylamide (page 100, 2nd column, section 3.7.1 – page 101, 1st column, 1st paragraph). Bedade teaches that method may comprise recovering the biocatalyst from the aqueous solution so that the solution does not contain a biocatalyst (page 101, 1st column 2nd paragraph). Bedade also teaches that the method may further comprise further processing the aqueous preparation with the reduced acrylamide content to obtain a final product (corresponding to spray drying to produce instant coffee) (page 102, 1st column, 3rd paragraph).
It would have been obvious for a person of ordinary skill in the art to have modified the method of Ordóñez to include contacting the permeate with a biocatalyst as taught by Bedade. Since Ordóñez discloses a method of reducing acrylamide in coffee (page 8, lines 1-2) and Bedade discloses a method of reducing acrylamide in coffee (page 100, 2nd column, section under 3.7.1), combining the steps disclosed by both references to form a single method represents “combining prior art elements according to known methods to yield predictable results”. The method disclosed in each reference merely performs the same function as it does separately and since these references show that the content of acrylamide would be reduced in the coffee, a skilled practitioner would readily recognize that the results of the combined references were predictable.
Therefore, the combination of Ordóñez and Bedade render a step of (iii) bringing P1 into contact with an acrylamide-reducing biocatalyst and obtaining permeate (P2) with a reduced acrylamide content obvious as the biocatalyst of Bedade may be used with the P1 of Ordóñez. The combination of Ordóñez and Bedade also render the claimed P2 not containing a biocatalyst obvious since Bedade discloses that the biocatalyst is removed from the coffee (page 101, 1st column 2nd paragraph).
Although the combined references do not explicitly disclose combining P2 with R1 to obtain the aqueous preparation having a reduced content of acrylamide as recited in step (iv) of the claimed method, the combination of Ordóñez and Bedade would render such a step obvious since Ordóñez discloses adding a high aromatic aqueous coffee extract to the permeate to provide a liquid coffee concentrate, wherein the high aromatic aqueous coffee extract contains a high amount of compounds responsible for the flavor of the coffee (page 8, lines 22-25; page 10, lines 4-6). Ordóñez discloses that an additional treatment step such as exposure to enzymes may interfere with the flavor profile of the coffee (page 2, lines 7-28); and that a goal of its invention is to better preserve the aromas of the coffee and to avoid the loss of desirable aromas during the filtration process (page 9, lines 12-15). As such, a skilled practitioner would have readily recognized that (A) P2 being added to R1 or (B) P2 being added to a high aromatic aqueous coffee extract results in a coffee product having reduced acrylamide content while conserving the taste profile of the coffee. Therefore, the addition of R1 to P2 as recited in step (iv) of the claimed method is rendered obvious.
The combination of Ordóñez and Bedade also renders step (v) of the claimed method obvious as Bedade discloses that the method may further comprise further processing the aqueous preparation with the reduced acrylamide content to obtain a final product (corresponding to spray drying to produce instant coffee) (page 102, 1st column, 3rd paragraph).
Regarding claims 2 and 3, Ordóñez teaches the invention as described above in claim 1, including the separation of the material streams in step (ii) is performed as membrane filtration (page 13, line 24-25; page 14, lines 22-32) as recited in present claims 2 and 3. Ordóñez teaches that the pore size of the membrane may be up to 100 Daltons (page 14, lines 9-13). This pore size falls within the claimed pore size range recited in present claim 3.
Regarding claim 4, Ordóñez teaches the invention as described above in claim 1, including the transmembrane pressure is and/or is maintained at up to 3000 kPa (page 15, lines 20-26). This maximum value of 3000 kPa equates to 30 bar so that the transmembrane pressure disclosed by Ordóñez encompasses the claimed range. It would have been obvious to one of ordinary skill in the art to select any portions of the disclosed ranges including the instantly claimed ranges from the ranges disclosed in the prior art references, particularly in view of the fact that; "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set percentage ranges is the optimum combination of percentages" In re Peterson 65 USPQ2d 1379 (CAFC 2003). Also In re Malagari, 182 USPQ 549,533 (CCPA 1974) and MPEP 2144.05.I.
Regarding claim 5, Ordóñez teaches the invention as described above in claim 1, including the end product is consumed as a beverage (page 1, lines 17-20). Therefore, the end product is at least for nutrition.
Regarding claims 6 and 7, modified Ordóñez teaches the invention as described above in claim 1, including the biocatalyst is an amidase (corresponding to acrylamidase) that is present as a partially purified and immobilized enzyme (Bedade page 96, 2nd column, section 2.3; page 97, 1st column, section 2.6).
Regarding claim 9, Ordóñez teaches the invention as described above in claim 1, including producing P1 by dividing the aqueous preparation into two material streams (Ordóñez, page 13, line 24-25; page 14, lines 22-32). Bedade rendered obvious the step of adding a biocatalyst to P1 as described in the rejection of claim 1 above, thereby rendering obvious the step of mixing P1 and the biocatalyst (page 100, 2nd column, section 3.7.1 – page 101, 1st column, 1st paragraph). Bedade renders a step of dividing the mixture into two material streams to obtain P2, wherein P2 does not contain the biocatalyst in disclosing recovering the biocatalyst from the aqueous preparation through methods such as filtrating or centrifugation (page 101, 1st column 2nd paragraph). Therefore, the combination of prior art renders present claim 9 obvious.
Regarding claim 11, modified Ordóñez teaches the invention as described above in claim 1, including producing P1 by dividing the aqueous preparation into two material streams (Ordóñez, page 13, line 24-25; page 14, lines 22-32); and contacting the aqueous preparation with an acrylamide-reducing biocatalyst, thereby obtaining an aqueous preparation with a reduced content of acrylamide (Bedade, page 100, 2nd column, section 3.7.1 – page 101, 1st column, 1st paragraph). The combination of Ordóñez and Bedade were shown to render step (iii) obvious as the biocatalyst of Bedade may be used with the P1 of Ordóñez. As such, the combination of prior art teaches that the method comprises: (iii-1) contacting P1 with an acrylamide-reducing biocatalyst and obtaining P2 having a reduced content of acrylamide, wherein P2 comprises the biocatalyst.
Bedade discloses that the biocatalyst may be separated from the aqueous preparation through filtration in order to produce a retentate containing the biocatalyst (page 101, 1st column 2nd paragraph), thereby producing P2 with a reduced content of acrylamide and no biocatalyst. Ordóñez discloses membrane filtration as known means of filtration (page 14, lines 9-11). Therefore, the combination of Ordóñez and Bedade renders step (iii-2) recited in present claim 11 obvious as it would have been obvious to use membrane filtration to produce P2 since membrane filtrations is known method of filtration in the art.
Regarding claims 12, 13, and 14, Ordóñez teaches the invention as described above in claims 1 and 11, including the step of (ii) dividing the aqueous preparation into two material streams, wherein the two streams are carried out using membrane filtration (Ordóñez, page 13, line 24-25; page 14, lines 9-11, 22-32). Bedade discloses that the biocatalyst may be separated from the aqueous preparation through filtration in order to produce a retentate containing the biocatalyst (page 101, 1st column 2nd paragraph), thereby producing P2 with a reduced content of acrylamide and no biocatalyst. Ordóñez discloses membrane filtration as known means of filtration (page 14, lines 9-11). Therefore, the combination of Ordóñez and Bedade renders step (iii-2) recited in present claim 11 obvious as it would have been obvious to use membrane filtration to produce P2 since membrane filtrations is known method of filtration in the art. Since it would have been obvious to use membrane filtration in steps (ii) and (iii-2) of the method, it would have been obvious to have used the same membrane, particularly wherein the practitioner had an interest in efficiency, low waste production, and/or cost-saving measures. Therefore, claims 12 and 13 are rendered obvious.
In using the same membrane for step (ii) and step (iii-2), the pore size of the membrane in step (ii) and the pore size of the membrane of step (iii-2) would be equal to each other. Since the membrane is used to remove the biocatalyst (Bedade, page 101, 1st column 2nd paragraph); and the same membrane is used in steps (ii) and (iii-2), the pore size of the membrane in step (ii) and the pore size of the membrane of step (iii-2) would be smaller than the biocatalyst. Therefore, the combination of prior art renders claim 14 obvious.
Regarding claim 15, Ordóñez teaches the invention as described above in claim 11, including that the pore size of the membrane may be up to 100 Daltons (page 14, lines 9-13). This pore size falls within the claimed pore size range recited in present claim 3.
Regarding claim 16, Ordóñez teaches the invention as described above in claim 11, including the transmembrane pressure is and/or is maintained at up to 3000 kPa (page 15, lines 20-26). This maximum value of 3000 kPa equates to 30 bar so that the transmembrane pressure disclosed by Ordóñez encompasses the claimed range. The selection of a value within the encompassing range renders the claimed range obvious. MPEP 2144.05.I.
Regarding claim 17, modified Ordóñez teaches the invention as described above in claim 1, including the biocatalyst completely degraded the acrylamide in the aqueous preparation (Bedade, page 101, 1st column, 1st paragraph; page 102, Fig. 5a). As described above in the rejection of claim 1, although the combined references do not explicitly disclose combining P2 with R1 to obtain the aqueous preparation having a reduced content of acrylamide as recited in step (iv) of the claimed method, the combination of Ordóñez and Bedade would render such a step obvious since Ordóñez discloses adding a high aromatic aqueous coffee extract to the permeate to provide a liquid coffee concentrate, wherein the high aromatic aqueous coffee extract contains a high amount of compounds responsible for the flavor of the coffee (page 8, lines 22-25; page 10, lines 4-6). Ordóñez discloses that an additional treatment step such as exposure to enzymes may interfere with the flavor profile of the coffee (page 2, lines 7-28); and that a goal of its invention is to better preserve the aromas of the coffee and to avoid the loss of desirable aromas during the filtration process (page 9, lines 12-15). As such, a skilled practitioner would have readily recognized that (A) P2 being added to R1 or (B) P2 being added to a high aromatic aqueous coffee extract results in a coffee product having reduced acrylamide content while conserving the taste profile of the coffee. Therefore, the addition of R1 to P2 as recited in step (iv) of the claimed method is rendered obvious.
At least wherein the skilled practitioner added P2 to R1, the resulting aqueous preparation with reduced content of acrylamide obtained in step (iv) may have a reduced acrylamide content of 100%, and thus an acrylamide content of 0 µg/kg, when compared to the aqueous preparation provided in step 1, since Bedade discloses complete degradation of acrylamide (page 101, 1st column, 1st paragraph; page 102, Fig. 5a). These values fall within the range of at least 20 wt.% based on the total weight of the aqueous preparation; and less than 2000 µg/kg based on the dry mass of the preparation recited in present claim 17. Therefore, the combination of Ordóñez and Bedade is considered to render the claim obvious.
Regarding claim 18, modified Ordóñez teaches the invention as described above in claim 1, including further processing the aqueous preparation with the reduced acrylamide content of step (iv) by spray drying in step (v) (Bedade, page 102, 1st column, 3rd paragraph).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Ordóñez (WO 2021/123163) in view of Bedade (Bedade et al., “Chitosan coated calcium alginate beads for covalent immobilization of acrylamidase: Process parameters and removal of acrylamide from coffee”, 2019, Food Chemistry, 275, pages 95-104) as applied to claim 1 above, and further in view of Watabe (JP2006340630A; English translation relied on for citations) as evidenced by search results filed 01/07/2026.
Regarding claim 8, modified Ordóñez teaches the invention as described above in claim 1, including the biocatalyst is an enzyme in the form of an amidase from Cupriavidus oxalaticus (Bedade, abstract). Purified enzymes and immobilized enzymes are known in the art as demonstrated by at least Bedade (page 96, 2nd column, section 2.3; page 97, 1st column, section 2.6). The prior art does not teach that the enzyme has an amino acid sequence as recited by present claim 8.
However, Watabe discloses that amidases and their function are known in the art (page 1, line 16); and discloses that several microbial-derived amidases are known and are used in the art (page 1, lines 21-26). Watabe discloses a purified amidase labeled as “SEQ ID NO: 10” (page 2, lines 33-34; page 5, lines 47-52) having 99.8% similarity to the total length of claimed SEQ ID NO: 1 as evidenced by Result 2 of the search results filed 01/07/2026.
It would have been obvious for a person of ordinary skill in the art to have modified the amidase from Cupriavidus oxalaticus of modified Ordóñez to be the amidase of Watabe as such a modification represents “[t]he selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945) (Claims to a printing ink comprising a solvent having the vapor pressure characteristics of butyl carbitol so that the ink would not dry at room temperature but would dry quickly upon heating were held invalid over a reference teaching a printing ink made with a different solvent that was nonvolatile at room temperature but highly volatile when heated in view of an article which taught the desired boiling point and vapor pressure characteristics of a solvent for printing inks and a catalog teaching the boiling point and vapor pressure characteristics of butyl carbitol. "Reading a list and selecting a known compound to meet known requirements is no more ingenious than selecting the last piece to put in the last opening in a jig-saw puzzle." 325 U.S. at 335, 65 USPQ at 301.).” MPEP 2144.07. Therefore, claim 8 is rendered obvious.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Ordóñez (WO 2021/123163) in view of Bedade (Bedade et al., “Chitosan coated calcium alginate beads for covalent immobilization of acrylamidase: Process parameters and removal of acrylamide from coffee”, 2019, Food Chemistry, 275, pages 95-104) as applied to claim 1 above, and further in view of Nguyen (Nguyen et al., “An Overview of Techniques in Enzyme Immobilization”, 2017, Appl. Sci. Converg. Technol., 26(6), pages 157-163).
Regarding claim 10, modified Ordóñez teaches the invention as described above in claim 1, including producing P1 by dividing the aqueous preparation into two material streams (Ordóñez, page 13, line 24-25; page 14, lines 22-32). Bedade rendered obvious the step of adding a biocatalyst to P1 as described in the rejection of claim 1 above, thereby rendering obvious the step of bringing P1 into contact with the biocatalyst (page 100, 2nd column, section 3.7.1 – page 101, 1st column, 1st paragraph). Immobilization of enzymes by covalent bonds between the enzyme and support matrix is known and widely used in the art as demonstrated by at least Bedade (page 95, 1st column, 1st paragraph; page 97, 1st column, section 2.6). The prior art does not teach that P1 is brought into contact with the biocatalyst via the contact surface of a membrane as recited in present claim 10.
However, Nguyen discloses that enzyme immobilization by covalent bonds between the enzyme and support matrix is known and widely used in the art (page 159, 2nd column, 1st paragraph under section 2.2). Nguyen also discloses that membranes are used as a support matrix (page 159, 2nd column, 1st paragraph under section 2.2).
It would have been obvious for a person of ordinary skill in the art to have modified the enzyme biocatalyst of modified Ordóñez to be immobilized on a membrane as taught by Nguyen. Since the immobilization of enzymes is widely used in the art and using membranes as a support matrix for the immobilized enzyme is also used in the art (Bedade, page 95, 1st column, 1st paragraph; page 97, 1st column, section 2.6; Nguyen, page 159, 2nd column, 1st paragraph under section 2.2), a skilled practitioner would have readily recognized that the enzyme biocatalyst of modified Ordóñez may be immobilized on a membrane, thus allowing P1 to be brought into contact with the biocatalyst via the contact surface of a membrane. Therefore, claim 10 is rendered obvious.
Conclusion
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/KELLY P KERSHAW/Examiner, Art Unit 1791