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 .
Election/Restrictions
Applicant's election with traverse of Group I (Claims 1-13 and 19-21) in the reply filed on 18 December 2025 is acknowledged. The traversal is on the ground(s) that there would not be serious search burden on the examiner. This is not found persuasive because Groups I and II require different fields of search.
The requirement is still deemed proper and is therefore made FINAL.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2, 3, and 9 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 2 recites the “wherein the baked or par-baked product is a type of bread” and the claim also recites “preferably a pan bread, toast bread, open bread, buns, Fino bread, Hammam bread, Samoli bread, baguettes, brioche, hamburger buns, rolls, brown bread, whole meal bread, rich bread, bran bread, flat bread, tortilla or biscuit, cake, or a patisserie” which makes it unclear if the limitations after “preferably” are required. For purposes of examination, the examiner is treating them as optional.
Claim 3 recites “the parent glucoamylase is from a species of Penicillium” and the claim also recites “preferably from Penicillium oxicalum, Penicillium miczynskii, Penicillium russellii or Penicillium glabrum” which makes it unclear if the limitations after “preferably” are required. For purposes of examination, the examiner is treating them as optional.
With regard to Claim 9 the claim states “of at least 150 compared to its parent”. It is unclear what unit “of at least 150” is referring too and thus it is unclear how to quantify the comparison of the variant to the parent enzyme.
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 1-13 and 19-21 are rejected under 35 U.S.C. 103 as being unpatentable over Feng et al (herein referred to as Feng, US 20160007618 A1) in view of Shows et al. (herein referred to as Shows, CA 03098718 A1) .
With regard to Claim 1, Feng teaches a method for producing a baked product (abstract). The method comprises providing a dough comprising a mature thermostable amylase ([0016]) and baking the dough to produce a baked product ([0015]).
However, feng is silent to the amylase being a mature thermostable variant of a parent glucoamylase at least 70% identical to SEQ ID NO:1, SEQ ID NO:6, SEQ ID NO:7 or SEQ ID NO:8.
Shows teaches processes for enhancing yeast growth and/or productivity (page 1 lines 7-8). Shows teaches the yeast can contain an amylase, and more specifically a glucoamylase (page 31 lines 20-25 lines 34-35). Shows teaches mature thermostable variants of a parent glucoamylase with at least a 70% sequence identity to the mature polypeptide (page 76 line 31 – page 77 line 8). The “mature polypeptide Shows in SEQ ID NOs: 21 in Shows is equivalent to SEQ ID NO: 1 in the instant application. Shows teaches the variants have reduced sensitivity to protease degradation and have improved thermostability compared to the parent (page 77 lines 20-24). Shows teaches the yeast has applications including baking (page 25 line 30).
It would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify Feng to utilize the mature thermostable variants of a parent glucoamylase with at least a 70% sequence identity to the mature polypeptide as taught it Shows because the variants have reduced sensitivity to protease degradation and have improved thermostability compared to the parent.
With regard to Claim 2, Feng teaches wherein the baked or par-baked product is a type of bread ([0043]).
With regard to Claim 3, Feng is silent to wherein the parent glucoamylase is from a species of Penicillium.
Shows teaches thermostable glucoamylase is preferably of fungal origin, preferably a filamentous fungi, such as from a strain of the genus Penicillium (page 76, lines 31-34)
With regard to Claims 4, 5, 6, and 7 Feng is silent to the mature variant comprising at least one amino acid modification, wherein the modification is a substitution, in one or more or all of the positions corresponding to positions 1, 2, 4, 6, 7, 11, 31, 34, 65, 79, 103, 132, 327, 445, 447, 481, 566, 568, 594 and 595 in SEQ ID NO:1.
Shows teaches the glucoamylase has an amino acid modification at position 79 (Page 76 lines 24-25). Shows teaches the modification is a substitution at position 79. (page 76 lines 24-25). Shows teaches the mutant glucoamylase has reduced sensitivity to protease degradation and has improved thermostability compared to the parent.
It would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify Feng to utilize the glucoamylase with an amino acid modification, specifically a substitution, at position 79 because the variants have reduced sensitivity to protease degradation and have improved thermostability compared to the parent.
With regard to Claim 8, Yeng is silent to the mature thermostable variant has a thermostability improvement (Td) over its parent of at least 30C.
Shows teaches the glucoamylase has an amino acid modification at position 79 (Page 76 lines 24-25) and more specifically Shows teaches the modification is a K79V substitution as stated in instant claims 19-21 (page 76 lines 24-25). Shows teaches these variant have improved thermostability compared to the parent (page 76, lines 22-23).
Therefore, Shows teaches the claimed method, including the specific modifications listed in instant claims 19-21, and thus, the resulting product would inherently have the claimed increase in thermostability, See MPEP 2112.01(I) which teaches 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). Not only are the compositions substantially identical, Shows explicitly states there is an increase in thermostability and therefore imparts reasoning for obviousness. See MPEP 2144.07 that discussed that when the prior art recognizes something is suitable for a similar intended use/purpose, such a thing is obvious.
With regard to Claim 9, Yeng is silent to wherein the mature thermostable variant has a relative activity at 910C of at least 150 compared to its parent.
Shows teaches the glucoamylase has an amino acid modification at position 79 (Page 76 lines 24-25) and more specifically Shows teaches the modification is a K79V substitution as stated in instant claims 19-21 (page 76 lines 24-25).
Therefore, Shows teaches the claimed method, including the specific modifications listed in instant claims 19-21, and thus, the resulting product would inherently have the claimed increase in thermostability, See MPEP 2112.01(I) which teaches 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)
With regard to Claim 10 and 11 The combination of Yeng and Shows teaches the claimed method and therefore, the resulting product would inherently have the claimed results, See MPEP 2112.01(I) which teaches 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).
With regard to Claim 12, Yeng is silent to wherein the mature thermostable variant glucoamylase enzyme is comprised in the dough in an amount of 0.01- 1,000 mg enzyme protein (mgEP) per kg flour.
Shows teaches the carbohydrate-source generating enzyme, in particular glycoamylase, may be added in amounts from 0.1- 100 micrograms EP/g DS, such as 0.5-50 micrograms EP/g DS, 25 such as 1-25 micrograms EP/g DS, such as 2-12 micrograms EP/g DS (page 79 lines 23-25). One with ordinary skill in the art would recognize the unit micrograms EP/g DS is micrograms per g of dry solids. In this case the dry solids would be flour. Converting the units to what is presented in the instant application, the range taught by Feng is converted to 100 – 100,000 micrograms EP/kg DS. See MPEP 2144.05(I) In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). Shows teaches the term "carbohydrate-source generating enzyme" includes any enzymes generating fermentable sugars. A carbohydrate-source generating enzyme is capable of producing a carbohydrate that can be used as an energy-source by the fermenting organism(s) (page 76 lines 18-21)
It would have been obvious to one with ordinary skill in the art to modify Feng in view of Shows to include the glucoamylase in an amount in amounts from 0.1- 100 micrograms EP/g DS to generate fermentable sugars.
With regard to Claim 13, Feng teaches the dough also comprises one or more additional enzymes (Claim 1, Feng reads such that the dough comprises a thermally-stable amyloglucosidase and an enzyme selected from the group consisting of: raw starch degrading amyloglucosidases; anti-staling amylases; and mixtures thereof). Feng teaches the additional enzyme can be a maltogenic amylase ([0068]).
With regard to Claims 19-21, Yeng is silent to wherein the at least one amino acid modification comprises a substitution in one or more or all of the positions corresponding to R1A, P2N, P4S, P11F, T65A, K79V and Q327F in SEQ ID NO:1.
Shows teaches the glucoamylase has an amino acid modification at position 79 (Page 76 lines 24-25). Shows teaches the modification is a K79V substitution (page 76 lines 24-25) Shows teaches the mutant glucoamylase has reduced sensitivity to protease degradation and has improved thermostability compared to the parent.
It would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify Yeng to include the K79V substitution taught by Shows to reduce the sensitivity to protease degradation and improve the thermostability compared to the parent.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KARLA I DIVIESTI whose telephone number is (571)270-0787. The examiner can normally be reached Monday-Friday 7am-3pm (MST).
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/K.I.D./Examiner, Art Unit 1792
/ERIK KASHNIKOW/Supervisory Patent Examiner, Art Unit 1792