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 .
Status of the Application
Receipt of the Response and Amendment after Non-Final Office Action filed 01/20/2026 is acknowledged.
Applicant has overcome the following rejections by virtue of the amendment or cancellation of the claims and/or persuasive remarks: (1) the 35 U.S.C. 103 rejection of claim 6 over Markosyan and Philippe et al. has been withdrawn; and (2) the 35 U.S.C. 103 rejections of claims 3, 5, 10, 11, and 13 over Philippe et al. in view of Prakash et al. have been withdrawn.
The status of the claims upon entry of the present amendment stands as follows:
Pending claims: 2-6, 10, 11, 13, 16, and 21
Withdrawn claims: None
Previously canceled claims: 1, 7-9, 12, 14, 15, 17-20, and 22-27
Newly canceled claims: 5 and 6
Amended claims: 3, 4, 11, and 16
New claims: None
Claims currently under consideration: 2-4, 10, 11, 13, 16, and 21
Currently rejected claims: 2-4, 10, 11, 13, 16, and 21
Allowed claims: None
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 16 and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Prakash et al. (WO 2018/075874 A1).
Regarding claim 16, Prakash et al. discloses rebaudioside N2 (p. 4, CC-00336; p. 93, ll. 9-10). Prakash et al. discloses a consumable product comprising rebaudioside N2 that is a cosmetic composition (p. 68, ll. 23-26, where “substances which are contacted with the mouth of man” are considered to include cosmetics, such as lip gloss; p. 1, ll. 11-12, where the term “cosmetic products” is listed as a sweetened composition that is intended to be modified via the substitution of natural caloric sugars with the non-caloric sweeteners of the invention). The limitation that the rebaudioside N2 is a “highly purified rebaudioside N2 composition having at least 80% rebaudioside by dry weight” is directed to the composition of the product prior to its incorporation into the consumable cosmetic composition, which causes the claim to be a product-by-process claim. MPEP 2113 I states: “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” The overall consumable product is only required to comprise the rebaudioside N2 component, which indicates that other steviol glycosides/rebaudiosides may be present in the consumable product. Whether those may potentially be added separately from the rebaudioside N2 component (in the case of a relatively pure rebaudioside N2 component that falls within the scope of “a highly purified rebaudioside N2 composition having at least 80% rebaudioside by dry weight”) or concurrently with the rebaudioside N2 component (in the case of a rebaudioside N2 component that does not meet the claimed purity requirement, or even in the case wherein a different primary steviol glycoside is added and rebaudioside N2 is present only as an impurity component) does not matter for the product-by-process claim, where only the composition of the product determines patentability. No concentration of the rebaudioside N2 composition is required in the finished consumable product. The claimed rebaudioside N2 purity limitations are thus insufficient to distinguish the claimed consumable product from the prior art. The disclosed product of Prakash et al. is thus adequate to anticipate the claimed composition.
As for claim 21, Prakash et al. discloses the consumable product as comprising rebaudioside B (p. 31, ll. 12-17; p. 33, ll. 18-22; p. 34, l. 5).
Claim Rejections - 35 USC § 103
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Markosyan (U.S. 2013/0287894 A1).
Regarding claim 2, Markosyan discloses a tri-glucosyl rebaudioside C ([0064]), where rebaudioside C is shown in Figure 1. Rebaudioside O4 as presently claimed differs from rebaudioside C only by three additional glucose subunits. The tri-glucosyl rebaudioside C disclosed in Markosyan is not limited in terms of where the additional glucose subunits are added on the original glucose subunits. The disclosure of tri-glucosyl rebaudioside C in Markosyan thus renders rebaudioside O4 obvious.
Claim 3, 4, 10, 11, and 13 is rejected under 35 U.S.C. 103 as being unpatentable over Markosyan (U.S. 2013/0287894 A1) in view of Markosyan et al. (hereinafter, “Markosyan II”) (U.S. 2014/0357588 A1).
Regarding claim 3, Markosyan discloses a method for producing di-glucosyl rebaudioside C (e.g., rebaudioside N2, which is equivalent to rebaudioside C by having two additional glucose subunits) ([0064]), the method comprising the steps of (a) providing a starting composition comprising rebaudioside C ([0038]-[0040]), (b) providing a biocatalyst that is an enzyme preparation containing at least one enzyme capable of transferring glucose residues from a glucose donor molecule to rebaudioside C, (c) contacting the biocatalyst with a medium containing the starting composition to produce a medium comprising di-glucosyl rebaudioside C (e.g., rebaudioside N2) ([0042]-[0043]), and (d) separating the rebaudioside N2 from the medium to provide a highly purified rebaudioside N2 composition ([0069], [0070], [0073]).
Markosyan does not explicitly disclose the starting composition as comprising sucrose and uridine diphosphate (UDP), the biocatalyst as comprising sucrose synthase (SuSy) and at least one UDP-glucosyltransferase (UGT), or the highly purified rebaudioside N2 composition as having greater than about 80% rebaudioside N2 content by weight on a dried basis.
However, Markosyan II discloses a biocatalytic process for preparing a target steviol glycoside, such as rebaudioside C, rebaudioside K, rebaudioside O, or a synthetic steviol glycoside ([0007], [0009]), wherein the reaction mixture contains sucrose and uridine diphosphate ([0169], [0171], Fig. 3) and a biocatalyst ([0015]) that comprises sucrose synthase ([0019], [0031], [0032], [0170], Fig. 3) and a UDP-glucosyltransferase (UGT76G1, UGT91D2) ([0019], [0025], [0027], [0028], Fig. 2, Fig. 3).
It would have been obvious to one having ordinary skill in the art to incorporate the reaction components taught in Markosyan II to the reaction mixture of Markosyan. Since Markosyan teaches that at least one enzyme capable of transferring glucose residues from a glucose donor molecule to rebaudioside C should be used in the method ([0042]), a skilled practitioner would be motivated to consult Markosyan II to clarify such suitable enzymes. Since Markosyan II discloses a biocatalytic process for preparing a range of various target steviol glycosides, including rebaudioside C, rebaudioside K, and steviol glycosides comprising additional glucose subunits ([0009]), a skilled practitioner would find the incorporation of UDP-glucosyltransferase enzymes (UGT76G1 and UGT91D2) and other biocatalytic materials (sucrose, uridine diphosphate, and sucrose synthase) into the reaction process of Markosyan to be obvious.
Further, the present specification indicates that rebaudioside C may be converted to rebaudioside N2 via various pathways that rely only on UGT76G1 and UGT91D2:
Fig. 2g: rebC > rebK with UGT91D2 or rebH4 with UGT76G1
Fig.2j: rebK > rebN2 with UGT76G1
Fig 2j: rebH4 > rebN2UGT91D2
A reaction mixture according to Markosyan comprising the two noted enzymes taught in Markosyan II (and specifically listed in Fig. 2) is thus presumed to produce rebaudioside N2. MPEP 2112.01 I states: “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established.” Since the combined method of Markosyan and Markosyan II is at least substantially identical to the method detailed in the present specification for obtaining rebaudioside N2, the claimed process, including addition of sucrose and uridine diphosphate to a starting composition and providing a biocatalyst comprising sucrose synthase and at least one UDP-glucosyltransferase, would be obvious to a skilled practitioner.
As for the purity of the separated component, Markosyan discloses the material may be subjected to “any type of chromatographic separation” ([0073]), which suggests that purifying the target steviol glycoside to a purity of up to 100% is within the scope of the disclosure of Markosyan. Markosyan II specifically discloses purifying the target steviol glycoside to greater than about 99% on a dry basis ([0139]). Thus, purifying the rebaudioside N2 content to greater than about 80% by weight on a dried basis would be obvious.
As for claim 4, Markosyan discloses a method for producing tri-glucosyl rebaudioside C (e.g., rebaudioside O4) of claim 2, the method comprising the steps of (a) providing a starting composition comprising rebaudioside C ([0038]-[0040]), (b) providing a biocatalyst that is an enzyme preparation containing at least one enzyme capable of transferring glucose residues from a glucose donor molecule to rebaudioside C, (c) contacting the biocatalyst with a medium containing the starting composition to produce a medium comprising tri-glucosyl rebaudioside C (e.g., rebaudioside O4) ([0042]-[0043]), and (d) separating the rebaudioside O4 from the medium to provide a highly purified rebaudioside O4 composition ([0069], [0070], [0073]).
Markosyan does not explicitly disclose the starting composition as comprising sucrose and uridine diphosphate (UDP), the biocatalyst as comprising sucrose synthase (SuSy) and at least one UDP-glucosyltransferase (UGT), or the highly purified rebaudioside O4 composition as having greater than about 80% rebaudioside O4 content by weight on a dried basis.
However, Markosyan II discloses a biocatalytic process for preparing a target steviol glycoside, such as rebaudioside C, rebaudioside O, or a synthetic steviol glycoside ([0007], [0009]), wherein the reaction mixture contains sucrose and uridine diphosphate ([0169], [0171], Fig. 3) and a biocatalyst ([0015]) that comprises sucrose synthase ([0019], [0031], [0032], [0170], Fig. 3) and a UDP-glucosyltransferase (UGT76G1, UGT91D2) ([0019], [0025], [0027], [0028], Fig. 2, Fig. 3).
It would have been obvious to one having ordinary skill in the art to incorporate the reaction components taught in Markosyan II to the reaction mixture of Markosyan. Since Markosyan teaches that at least one enzyme capable of transferring glucose residues from a glucose donor molecule to rebaudioside C should be used in the method ([0042]), a skilled practitioner would be motivated to consult Markosyan II to clarify such suitable enzymes. Since Markosyan II discloses a biocatalytic process for preparing a range of various target steviol glycosides, including rebaudioside C and steviol glycosides comprising additional glucose subunits ([0009]), a skilled practitioner would find the incorporation of UDP-glucosyltransferase enzymes (UGT76G1 and UGT91D2) and other biocatalytic materials (sucrose, uridine diphosphate, and sucrose synthase) into the reaction process of Markosyan to be obvious.
Further, the present specification indicates that rebaudioside C may be converted to rebaudioside O4 via various pathways that rely only on UGT76G1 and UGT91D2:
Fig. 2g: rebC > rebH2 with UGT91D2
Fig.2j: rebH2 > rebN3 with UGT91D2 or rebN4 with UGT76G1
Fig 2l: rebN3 > rebO4 with UGT76G1 or rebN4 > rebO4 with UGT91D2
OR
Fig 2g: rebC > rebH4 with UGT76G1
Fig 2j: rebH4 > rebN2 or rebN4 with UGT91D2
Fig 2l: rebN2 or rebN4 > rebO4 with UGT91D2
Fig 2l of the present specification further indicates that rebO4 is the terminal compound from numerous reaction pathways, with no apparent additional modification occurring (Fig. 2l). A reaction mixture according to Markosyan comprising the two noted enzymes taught in Markosyan II (and specifically listed in Fig. 2) is thus presumed to produce rebaudioside O4, so long as a reaction time is adequate. MPEP 2112.01 I states: “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established.” Since the combined method of Markosyan and Markosyan II is at least substantially identical to the method detailed in the present specification for obtaining rebaudioside O4, the claimed process, including addition of sucrose and uridine diphosphate to a starting composition and providing a biocatalyst comprising sucrose synthase and at least one UDP-glucosyltransferase, would be obvious to a skilled practitioner.
As for the purity of the separated component, Markosyan discloses the material may be subjected to “any type of chromatographic separation” ([0073]), which suggests that purifying the target steviol glycoside to a purity of up to 100% is within the scope of the disclosure of Markosyan. Markosyan II specifically discloses purifying the target steviol glycoside to greater than about 99% on a dry basis ([0139]). Thus, purifying the rebaudioside O4 content to greater than about 80% by weight on a dried basis would be obvious.
As for claim 10, Markosyan II discloses the microorganism as being E. coli ([0024]).
As for claim 11, Markosyan II discloses the biocatalyst as being an enzyme capable of converting rebaudioside C to rebaudioside N2 ([0025]).
As for claim 13, Markosyan II discloses the enzymes as being UGT76G1 and UGT91D2 ([0025], Fig. 2).
Double Patenting
Claim 2 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 7 of U.S. Patent No. 10,743,572 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘572 patent claims a composition comprising glycosylated steviol glycosides, which is considered to encompass the compound of present claim 2, thus rendering such composition obvious.
Claims 2 and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 10,729,163 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘163 patent claims a composition comprising glycosylated steviol glycosides having up to nine α-1,4-glucosyl residues, which is considered to encompass the compound of present claim 2, thus rendering such a compound and compositions comprising such a compound obvious.
Claim 2 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4-7 of U.S. Patent No. 10,130,116 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘116 patent claims a taste and flavor modifying composition comprising glycosylated steviol glycosides that comprise glycosylated steviol glycosides, which is considered to encompass the compound of present claim 2, thus rendering such a compound and compositions comprising such a compound obvious.
Claims 2 and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 16-19 of U.S. Patent No. 9,615,599 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘599 patent claims a taste and flavor modifying composition comprising α-1,4-glucosyl derivatives, which is considered to encompass the compound of present claim 2, thus rendering such a compound and compositions comprising such a compound obvious.
Claims 2 and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 26-29 of U.S. Patent No. 9,603,373 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘373 patent claims a process for producing a composition comprising steviol glycosides having up to 20 α-1,4-glucosyl residues, which is considered to encompass the compound of present claim 2, thus rendering such a compound and compositions comprising such a compound obvious.
Claim 2 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4-7 of U.S. Patent No. 9,420,815 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘815 patent claims a taste and flavor modifying composition comprising glucosylated steviol glycosides having up to nine glucosyl residues, which is considered to encompass the compound of present claim 2, thus rendering such a compound and compositions comprising such a compound obvious.
Claim 2 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 9,392,799 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘799 patent claims a process for making a glucosylated steviol glycosides having up to nine α-1,4-glucosyl residues, which is considered to encompass the compound of present claim 2, thus rendering such a compound and compositions comprising such a compound obvious.
Claim 2 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3 of U.S. Patent No. 9,107,436 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘436 patent claims a taste and flavor modifying composition comprising glucosylated steviol glycosides having different degrees of glycosylation, which is considered to encompass the compound of present claim 2, thus rendering such a compound and compositions comprising such a compound obvious.
Claims 2 and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 18-21 of U.S. Patent No. 9,055,761 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘761 patent claims a process for producing a composition comprising steviol glycosides having up to 20 α-1,4-glucosyl residues, which is considered to encompass the compound of present claim 2, thus rendering such a compound and compositions comprising such a compound obvious.
Claims 2 and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 22-25 of U.S. Patent No. 8,993,269 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘269 patent claims a process for producing a composition comprising steviol glycosides having one or more α-1,4-glucosyl residues, which is considered to encompass the compound of present claim 2, thus rendering such a compound and compositions comprising such compounds obvious.
Claims 2 and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 17-20 of U.S. Patent No. 8,911,971 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘971 patent claims a process for producing a composition comprising steviol glycosides having up to 20 α-1,4-glucosyl residues, which is considered to encompass the compound of present claim 2, thus rendering such a compound and compositions comprising such a compound obvious.
Response to Arguments
Claim Rejections - 35 U.S.C. § 102(a)(1) of claims 16 and 21 over Prakash et al.: Applicant’s arguments have been fully considered but they are not persuasive.
Applicant argued that the amendment to claim 16 requiring the composition to comprise a highly purified rebaudioside N2 composition having at least about 80% rebaudioside N2 distinguishes the claim from the prior art (Applicant’s Remarks, p. 1, ¶4 – p. 3, ¶3).
As described in the claim rejection, though, claiming the purity of a component prior to its addition to the final composition causes the claimed composition to be a product-by-process claim, where the process step does not limit the claimed composition. A final composition comprising rebaudioside N2 meets the requirements of claim 16 regardless of its method of preparation, including whether or not the starting material was a rebaudioside N2 component having the claimed purity. Applicant’s arguments are unpersuasive.
The rejections of claims 16 and 21 have been maintained herein.
Claim Rejections - 35 U.S.C. § 103 of claim 2 over Markosyan: Applicant’s arguments have been fully considered but they are not persuasive.
Applicant argued: “A. Rebaudioside O4 is a structurally defined species, not simply a ‘tri-glucosyl rebaudioside C’”, and asserted that the disclosure of Markosyan was “purely genus-level” without detailing specific characteristics or analytical data of rebaudioside O4 (Applicant’s Remarks, p. 4, ¶4 – p. 5, ¶3). Applicant alleged that “a genus listing without species-level structural assignments cannot disclose the claimed species”. Id.
However, Examiner maintains that the disclosure of Markosyan regarding tri-glucosyl rebaudioside C compounds is adequately specific to deem the claimed rebaudioside O4 obvious. A skilled practitioner would readily envisage any of the potential compounds. U.S. Patent No. 9,894,922 B2, which is the issued patent corresponding to U.S. 2013/0287894 A1 and which Examiner notes is from the same Markosyan that is the first-named inventor of the present application, claimed in claim 1 “[a] process for preparing a glucosyl Rebaudioside C composition”, wherein the product was merely “the glucosyl Rebaudioside C composition comprising at least 20% glucosyl Rebaudioside C”. No additional specificity was thought necessary at the time in terms of the orientation of glucose subunits. The Markosyan (U.S. 2013/0287894 A1) application and its corresponding patent (the ‘922 patent) serve as evidence that the skill in the art as of the time of the presently-claimed invention was such that (i) additional clarification regarding the exact orientation of glucose subunits in a glucosylated rebaudioside C compound was not necessary, (ii) a skilled practitioner would be adequately apprised of the scope of the resultant glucosyl rebaudioside C compounds, and (iii) the patented process was adequately enabled. No additional specific characteristics or analytical data is necessary to elucidate rebaudioside O4 from the disclosure of Markosyan.
Applicant’s statement that “a genus listing without species-level structural assignments cannot disclose the claimed species” (Applicant’s Remarks, p. 5, ¶3) is unsupported. MPEP 2144.08 indicates that a single reference 35 U.S.C. 103 rejection may be appropriate where the reference discloses a genus encompassing a claimed species, particularly when the level of skill in the art as shown in the previous paragraph was demonstrated by the present applicant as considering the claimed species to be adequately disclosed as being part of a genus. The size of the genus also weighs in favor of obviousness, since a tri-glucosyl rebaudioside C encompasses only rebaudioside C molecules with three additional glucose subunits distributed in positions that are known in the art.
Applicant argued: “B. The prior art does not teach or suggest the specific β-linkage pattern of rebaudioside O4”, and asserted analytical data detailing the characteristics of the compound (Applicant’s Remarks, p. 5, ¶4 – p. 8, ¶2; Markosyan Declaration, [0004]-[0006]). Applicant concluded that “[t]he Office’s contention that Applicant has not distinguished the species is therefore moot.” (Applicant’s Remarks, p. 6, ¶3).
Examiner’s statement at paragraph 52 of the previous Office Action was merely intended to highlight that Applicant’s arguments regarding the asserted distinctive attributes of rebaudioside O4 could likewise be applied to any other compounds that fall within the class of tri-glucosyl rebaudioside C compounds. Applicant did not assert that all the other compounds in the class would not also be characterized by specific molecular distinctions. Examiner did not intend to suggest that the claimed compound needed any more specific “species-level structural assignments that distinguish rebaudioside O4 from all other tri-glucosyl isomers”. It is also unnecessary for the prior art to provide analytical data supporting the specific confirmation of rebaudioside O4.
Applicant argued: “C. Structural connectivity is not predictable; enzymology and donor chemistry determine linkage topology”, and asserted that novelty rests on structural features rather than the method of production (Applicant’s Remarks, p. 8, ¶2 – p. 9, ¶2). Applicant further asserted that glycosylation of steviol glycosides yields complex mixtures of compounds, and “CGTase-based systems such as those disclosed in Markosyan are mechanistically restricted to α-1,4 transfer chemistry” (Applicant’s Remarks, p. 8, ¶3 – p. 9, ¶1).
Examiner maintains that the disclosure of Markosyan is adequate to deem the claimed structure obvious. Markosyan is not limited to “CGTase-based systems” ([0042]), even if such enzymes appear in the examples. MPEP 2123 II. The reference is not limited any particular mechanism for enzymatic glucosylation of steviol glycosides.
The updated rejection of method claim 4 provides rationale that further undermines Applicant’s argument against the structure of rebaudioside O4 being obvious. The rejection of claim 4 details that nothing other than two enzymes known for being used in the glycosylation of steviol glycosides is necessary for producing rebaudioside O4 from rebaudioside C. Markosyan II indicates such enzymes may also be used in the glucosylation of stevioside to rebaudioside D (Figs. 2 and 3), which, according to the present specification, may thus also apparently result in the incidental production of rebaudioside O4 should the enzymes be allowed to remain active. Such incidental production undermines the argument that rebaudioside O4 was designed on the basis of it structural features.
That glycosylation of steviol glycosides may yield complex mixtures of compounds does not alter the patentability analysis, since the target compounds may be purified (Markosyan, [0073]).
Applicant argued: “D. Prior work by the same inventor does not disclose or suggest the claimed species”, and asserted that the allegedly broad disclosures of the prior art should not be sufficient to deem the claimed composition obvious (Applicant’s Remarks, p. 9, ¶3).
However, the claim rejection relies only on the disclosure in Markosyan of a tri-glucosyl rebaudioside C ([0064]). Examiner maintains that such disclosure is not so broad that it is insufficient to deem the claimed compound obvious. The shared inventorship between the prior art and the present application was to highlight that Applicant, too, did not view the disclosure of the earlier patent application and subsequently-issued patent as being too broad to suggest the specific compounds that fall within the designation of being “tri-glucosyl Reb C”, especially to the point that the patented process of the ‘922 patent should be deemed to be inadequately enabled as presently asserted by Applicant. The shared inventorship further serves as evidence as to the ordinary skill in the art at the time of the present invention. The present inventor earlier apparently held the position that the disclosure of the cited prior art was adequate for producing glucosylated rebaudioside C compositions.
Applicant argued: “E. Exhibit D now provides the very evidence the Office stated was missing” in terms of mechanistic limitations regarding the feasibility of producing rebaudioside O4, particularly as related to CGTase functionality and the type of orientation of added glucose subunits that may be achieved (Applicant’s Remarks, p. 9, ¶4 – p. 10, ¶2).
However, the argument is moot in view of the rejection of claim 4 regarding the method of production of the compound. Rebaudioside O4 as claimed in claim 2 is not limited to being produced by any particular enzymatic glucosylation method ([0042]), and Markosyan II discloses enzymes used in the same context as those disclosed in the present specification for obtaining rebaudioside O4. The β-branched steviol glycosides would be attainable based on the enzymes taught in Markosyan II. MPEP 2112.01 I.
Applicant argued: “F. Exhibit D confirms that CGTase systems cannot produce the claimed β-branched architecture” (Applicant’s Remarks, p. 10, ¶3 – p. 11, ¶1).
Again, though, Markosyan is not limited to any particular type of enzymatic glucosylation ([0042]), and Markosyan II discloses the same enzymes for steviol glycoside glucosylation that are used in the present application for obtaining rebaudioside O4.
Applicant argued: “G. Inventorship overlap does not cure the absence of species-level teaching” (Applicant’s Remarks, p. 11, ¶2).
The relevance of shared inventorship was addressed previously herein in paragraph 55. Examiner maintains that the disclosure of Markosyan is adequate to deem the claimed compound obvious and that no additional “species-level teaching” is necessary to support the rejection.
Applicant argued: “H. Functional similarity does not equal structural identity”, asserting that suitability as sweetness enhancers or sweeteners does not equate to functional predictability (Applicant’s Remarks, p. 11, ¶3 – p. 12, ¶1).
However, Examiner’s comments at paragraph 52 were only in response to the assertion by Applicant that the potential compounds that may be produced resulted in “a vast and unpredictable design space”. Examiner maintains that because Markosyan indicates the compounds may be used as sweeteners or sweetness enhancers, then describing the potential characteristics of produced compounds as being “vast and unpredictable” mischaracterizes the actual state of the art. The assertion of unpredictability on the basis of the data in Table 5 is unpersuasive, since (i) Applicant highlighted a single characteristic apparently thought to best support the assertion of unpredictability, while ignoring the “[o]verall evaluation” that resulted in less variance, (ii) samples 1 and 2 differ in terms of the base steviol glycoside that is glycosylated (i.e., stevioside, rebaudioside A, and rebaudioside C) rather than being a comparison between only different glucosylated rebaudioside C compounds, and (iii) the analytical method based on observations of 10 panelists is insufficient to support a conclusion that there is “substantial variation” and “functional unpredictability”. All control and experimental samples were shown to have “Clean” quality of sweetness and “Satisfactory” overall evaluation—identical characterizations as those of sucrose.
Applicant’s arguments are unpersuasive.
The rejection of claim 2 has been maintained herein.
Claim Rejections - 35 U.S.C. § 103 of claims 4 and 6 over Markosyan and Philippe et al.: Applicant’s arguments (Applicant’s Remarks, p. 12, ¶3 – p. 15, ¶1; p. 19, ¶1; supplemental evidentiary documents) have been fully considered and are persuasive to the extent that claim 4 as presently amended would not be obvious in view of Markosyan and Philippe et al. However, upon further consideration, a new ground of rejection is made in view of Markosyan and Markosyan II, which overcomes all of Applicant’s arguments based on the type of enzyme used for glucosylation.
Applicant reasserted arguments regarding the obviousness of rebaudioside O4 as a composition (Applicant’s Remarks, p. 15, ¶2 – p. 16, ¶3), which were all addressed previously in relation to claim 2 and determined to be unpersuasive.
Applicant next argued that purification to ≥80% is not disclosed in the art (Applicant’s Remarks, p. 16, ¶4 – p. 17, ¶4).
However, Markosyan II specifically discloses purifying the target steviol glycoside to greater than about 99% on a dry basis ([0139]), which renders Applicant’s argument moot.
Applicant next argued that Examiner’s position that no experimentation would be necessary to produce rebaudioside O4 was inconsistent with the technical record (Applicant’s Remarks, p. 17, ¶5 – p. 18, ¶4).
However, Examiner’s position is overcome by the amendments of the present claim, which drastically narrow the claim’s scope. The reliance on Markosyan II in the claim rejection, though, addressed Applicant’s remaining arguments regarding the nature of the glucosylating enzymes.
The rejection of claim 4 has been updated and maintained herein.
Claim Rejections - 35 U.S.C. § 103 of claims 3, 5, 10, 11, and 13 over Philippe et al. and Prakash et al.: Applicant’s arguments (Applicant’s Remarks, p. 19, ¶2 – p. 24, ¶4) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
The rejections of claims 3, 5, 10, 11, and 13 are withdrawn as related to Philippe et al. and Prakash et al., but the claims that remain pending are newly rejected in view of Markosyan and Markosyan II.
Double patenting: Applicant deferred responding to the double patenting rejections (Applicant’s Remarks, p. 24, ¶5).
The double patenting rejections have been maintained herein.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Claims 2-4, 10, 11, 13, 16, and 21 are rejected.
No claims are allowed at this time.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEFFREY P MORNHINWEG whose telephone number is (571)270-5272. The examiner can normally be reached 8:30AM-5:00PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Emily Le can be reached at 571-272-0903. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JEFFREY P MORNHINWEG/Primary Examiner, Art Unit 1793
Prosecution Insights