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 .
Claim status
Claims 1-19 filed 10/24/2024 are pending in the application and are hereby examined on the merits.
Claim Objections
Claim 2 is objected to because of the following informalities “Penicillium oxicalum” should read “Penicillium oxalicum” Appropriate correction is required.
Claim 13 is objected to because of the following informalities “AMG” should read “glucoamylase”. Appropriate correction is required.
Claim Warning
Applicant is advised that should claim 6 be found allowable, claim 7 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 1 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabled for a method using an enzyme having phospholipase activity with 100% identity to SEQ ID NO: 1, 6-8 or 10, does not reasonably provide enablement for a . The specification does not disclose any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims. Case law holds that applicant’s specification must be “commensurately enabling [regarding the scope of the claims]” Ex Parte Kung, 17 USPQ2d 1545, 1547 (Bd. Pat. App. Inter. 1990). Otherwise undue experimentation would be involved in determining how to practice and use applicant’s invention. The test for undue experimentation as to whether or not all enzyme variants within the scope of claim 1 can be used as claimed and whether claim 1 meets the test is stated in Ex parte Forman, 230 USPQ 546, 547 (Bd. Pat. App. Inter. 1986) and In re Wands, 8 USPQ2d 1400, 1404 (Fed.Cir. 1988). Upon applying this test to claim 1 it is believed that undue experimentation would be required to make or use an invention commensurate with the full scope of these claims because:
(a) The quantity of experimentation necessary is great: claim 1 reads on a variant of a glucoamylase that comprises sequence having at least 70% identity to SEQ ID NO:1, 6-8 or 10, which is used to saccharify a liquefied mash to produce a wort. Given that each of SEQ ID No: 1, 6-8 and 10 have 590+ amino acids, a polypeptide having up to 30% of the amino acids (e.g., 590 x30% =177 amino acids) that vary from those in SEQ ID No: 1, 6-8 and 10 will encompass a large number of variations. Further, enzyme activity is determined by active sites and a single change in an amino acid sequence can destroy the functionality of an enzyme. However, the specification does not disclose the enzymatic activity of a polypeptide that is 70% identity to SEQ ID No: 1, 6-8 and 10. As such, great quantity of experimentation is needed to identify the polypeptides that meet the sequence identity to SEQ ID No: 1, 6-8 and 10 and great quantity of experimentation is needed to test if a polypeptide that meets the sequence identities to SEQ ID No: 1, 6-8 and 10 could perform the function as recited in claim 1, and the predictability that if a polypeptide that meets the sequence identity will perform the function recited in claims is low.
(b) The nature of the invention, the breadth of the claim and the level of one ordinary skill in the art: the claim is directed to a method of producing brewer wort comprising treating mash with a variant of a parent glucoamylase; the claim is broad because it recites at least 70% sequence identity to SEQ ID No: 1, 6-8 or 10; and the level of an ordinary skill in the art is a biochemist and food chemist who is familiar with molecular biology and beermaking.
(b) Applicant has not identified which portion of the sequence must be preserved in order to preserve the function of the enzyme and the quantity of experimentation to determine this portion is great given the unpredictability of enzyme conformations.
(c) There is an absence of working examples concerning a polypeptide that is 70% sequence as compared to SEQ ID No: 1, 6-8 and 10..
In light of the above factors, it is seen that undue experimentation would be necessary to use the invention of claim 1.
Claims 2-19 ultimately depend from claim 1 thus necessarily incorporate the enablement issue therein.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “ a mature thermostable variant of a parent glucoamylase with at least 70% sequence identity to SEQ ID NO: 1, SEQ ID NO: 6, SEQ ID NO: 7, SEQ ID NO: 8 or SEQ ID NO: 10”. It is unclear whether it is the mature thermostable variant or the parent glucoamylase that has the at least 70% sequence identity to SEQ ID NO: 1, 6-8 and 10. Further, the phase “mature” or “thermostable” renders the claim indefinite because absent standard, it is unclear what variant is considered mature or thermostable and what variant is not. Additionally, it is unclear what a “variant” is referring to. Does it have an alteration of the amino acid at a specific position? Clarification is required. Claims 2-19 ultimately depend from claim 1 therefore necessarily incorporate the indefinite subject matter therein. Appropriate correction is required.
Claim 2 recites “preferably”, which renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP 2173.05 (d). Appropriate correction is required.
Claim 12 recites that the pH of the mash is 4.6-6.4. the limitation renders the claim indefinite because it is unclear if the limitation means that the pH of the mashing process is at the pH range, or the mash as a substrate has that pH. Clarification is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-14 and 16-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Craig WO 2014/085439 A1 (cited in the IDS submitted 10/24/2024, hereinafter referred to as Craig).
Regarding claims 1-8, 11-12, 14 and 16-19, Craig teaches a method of producing a fermented product such as beer (page 10, line 29-32), the method comprising liquefying mash (e.g., a starch-containing material, for example mash, see Example 18) with alpha-amylase and protease at a pH of 5-6.5 (or narrowly 5-6) and at a temperature of 70-100 °C such as 85 °C for 103 min, saccharifying using a thermostable glucoamylase that is from Penicillium oxalicum or a variant thereof, and fermenting (page 1, line 33- page 2, line 19; page 3, line 12-17; Example 18). A brewer’s wort is inherently produced by Craig, given that the purpose of Craig is to prepare a beer.
Further, Craig teaches that the thermostable glucoamylase is a variant of mature wildtype Penicillium oxalicum glucoamylase (e.g., SEQ ID No: 14 of Craig, which corresponds to SEQ ID No: 1 of the instant claim 1), for example, Criag lists the thermostable variants comprising at least one amino acid modification in the corresponding to position of 1 (e.g., R1K), 2 (e.g., P2N), 4 (e.g., P4S), 7 (e.g., G7V), 11 (e.g., P11S), 65 (e.g., T65A), 79 (e.g., K79V), 327 (e.g., Q327F), 501 (e.g., E501V), etc. of SEQ ID NO:1 of the instant claim 1 (page 22, line 25- page 25, line 23; Table 15). Since SEQ ID No: 1 has 595 amino acid thus a variant has 70% sequence identity to SEQ ID No: 1 will have 595 x30% =~178 amino acid substitution thus all those variants as listed by Craig shown above meet the variant of claim 1. Specifically, PE001 as disclosed by Craig is SEQ ID No: 1 of instant claim 1 with K79V substitution, which corresponds to “AMG_NL” as recited in the instant disclosure, and GA498 as disclosed by Craig is SEQ ID No: 1 of instant claim 1 with P2N P4S P11F T65A K79V Q327F substitution, which corresponds to “AMG_anPAV498” as recited in the instant disclosure (see Table 15 of Craig).
Regarding claim 9, Craig teaches that PE001 has Td value of 83.4 °C, GA498 has Td value of 88.4 °C and GA110 has a Td value of 90.6 °C (Table 15). Given that Craig teaches that wildtype Penicillium oxalicum glucoamylase is sable up to 70 °C (Example 4), claim 9 is met by Craig.
Regarding claims 9, 10 and 13, given that Craig teaches a Penicillium oxalicum thermostable glucoamylase variant that meets claim 1, 3-8 and 18-19 or the instant disclosure, it logically follows that variant as disclosed by Criag has the thermostability property, the relative activity or saccharification property as recited in claims 9, 10 and 13. See MPEP 2112.01 I, 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. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977).
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.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Craig as applied to claim 1 above, further in view of Frederiksen WO 2012/140075 A2 (hereinafter referred to as Frederiksen).
Regarding claim 15, Craig as recited above teaches adding a mash a thermostable variant of a parent glucoamylase to produce a wort. Criag is silent regarding that the wort has more than 80% glucose by weight of the total carbohydrate content of the wort.
Frederiksen in the same field of endeavor teaches a method of producing wort comprising adding to mash a glucoamylase (page 2, line 6-7), wherein a wort having at least 80% glucose is produced so as to produce a low carbohydrate content beer as a result that glucoamylase will cleave the un-fermented dextrin to glucose in the mash (page 5, bottom para. and page 12, line 13-18).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified Craig by making a wort that has more than 80% glucose so as to produce a beer that has low carb content.
Conclusion
Pertinent art
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure
Ford, “Improving operating performance of glucoamylase by mutagenesis”, Current Opinion in Biotechnology, 1999, 10(4), pages 353-357, and Reilly, “Protein Engineering of Glucoamylase to Improve Industrial Performance – A Review”, Starch, 1999, 51(8-9), pages 269-274, each of which teach improving the thermostability of glucoamylase by site-directed mutagenesis.
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/CHANGQING LI/Primary Examiner, Art Unit 1791
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