DETAILED ACTION
The present application is being examined under the pre-AIA first to invent provisions.
Claims 15-29 are pending and under consideration in this Office Action.
Claim Rejections - 35 USC § 112(b) or 35 U.S.C. 112 (pre-AIA ) 2nd Paragraph
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 16, 22, 27, 29 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 pre-AIA the applicant regards as the invention.
The claims recite “preferably” which renders the claims vague and indefinite since it is unclear if the the claims are limited to the subject matter recited after “preferably”.
Claim Rejections - 35 USC § 112
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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.
Claims 15-29 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims are drawn to a broad and widely varying genus of compositions comprising a genus of alpha-amylases of any amino acid sequence and structure and a genus of proteases of any amino acid sequence and structure, wherein the i) alpha- amylase has a T2 (min) at pH 4.5, 85°C, 0.12 mM CaCI2) of at least 10; ii) protease having a thermostability value of more than 20% determined as Relative Activity at 80°C/70°C. According to MPEP 2163:
“For each claim drawn to a genus: The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A), above), reduction to drawings (see i)(B), above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus (see i)(C), above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014)…”
According to MPEP 2163.02:
“The courts have described the essential question to be addressed in a description requirement issue in a variety of ways. An objective standard for determining compliance with the written description requirement is, "does the description clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed." In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989). Under Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991), to satisfy the written description requirement, an applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention, and that the invention, in that context, is whatever is now claimed. The test for sufficiency of support in a parent application is whether the disclosure of the application relied upon "reasonably conveys to the artisan that the inventor had possession at that time of the later claimed subject matter." Ralston Purina Co. v. Far-Mar-Co., Inc., 772 F.2d 1570, 1575, 227 USPQ 177, 179 (Fed. Cir. 1985) (quoting In re Kaslow, 707 F.2d 1366, 1375, 217 USPQ 1089, 1096 (Fed. Cir. 1983)).”
The reference of Chica et al. (Curr Opin Biotechnol. 2005 Aug;16(4):378-84; IDS filed 01/14/2025) teaches that the complexity of the structure/function relationship in enzymes has proven to be the factor limiting the general application of rational enzyme modification and design, where rational enzyme modification and design requires in-depth understanding of structure/function relationships. The reference of Singh et al. (Curr Protein Pept Sci. 2017, 18, 1-11; IDS filed 01/14/2025) reviews protein engineering methods including directed evolution, rational design, semi-rational design, and de-novo design; and states that despite the availability of a growing database of protein structures and highly sophisticated computational algorithms, protein engineering is still limited by the incomplete understanding of protein functions, folding, flexibility, and conformational changes (see entire publication especially Figs.1 and 3, and page 7, left column, lines 8-17). The reference teachings only provide guidance for searching and screening for the mutant.
The specification as originally filed does not disclose a representative number of species encompassed by the claimed genus by actual reduction to practice. The specification as originally filed does not provide a correlation between function and structure to enable one of ordinary skill in the art to predict which amino acid sequences, structures, and amino acid mutations that correlate with the alpha-amylase activity and protease activity, wherein the i) alpha- amylase has a T2 (min) at pH 4.5, 85°C, 0.12 mM CaCI2) of at least 10; ii) protease having a thermostability value of more than 20% determined as Relative Activity at 80°C/70°C.
The specification discloses a Bacillus stearothermophilus alpha-amylase having a T1/2 (min) at pH 4.5, 85°C, 0.12 mM CaCl2 of at least 10, wherein the alpha-amylase comprises the amino acid sequence of SEQ ID NO:1 with mutations selected from the group of: I181*+G182*+N193F+V59A+Q89R+E129V+K177L+R179E+H208Y+K220P+N224L+Q254S; I181*+G182*+N193F+E129V+K177L+R179E; and I181*+G182*+N193F+E129V+K177L+R179E+K220P+N224L+S242Q+Q254S; and a Pyrococcus protease having at least 95% identity to SEQ ID NO: 13 and a thermostability value of more than 20% determined as Relative Activity at 80° C/70°C.
Hence, the specification does not provide sufficient written description to inform one of ordinary skill in the art that applicants were in possession at the time the application was filed of the claimed broad and widely varying genus of compositions comprising a genus of alpha-amylases of any amino acid sequence and structure and a genus of proteases of any amino acid sequence and structure, wherein the i) alpha- amylase has a T2 (min) at pH 4.5, 85°C, 0.12 mM CaCI2) of at least 10; ii) protease having a thermostability value of more than 20% determined as Relative Activity at 80°C/70°C.
Claim Rejections - 35 U.S.C. § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
According to MPEP 2143:
“Exemplary rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield
predictable results;
(B) Simple substitution of one known element for another to obtain predictable
results;
(C) Use of known technique to improve similar devices (methods, or products)
in the same way;
(D) Applying a known technique to a known device (method, or product) ready
for improvement to yield predictable results;
(E) “ Obvious to try ” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in
either the same field or a different one based on design incentives or other market
forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art
reference teachings to arrive at the claimed invention.
Note that the list of rationales provided is not intended to be an all-inclusive list. Other rationales to support a conclusion of obviousness may be relied upon by Office personnel.”
Claim 1-50 and 69-71 are rejected under 35 U.S.C. 103(a) as being unpatentable over Cheng et al. (Appl Biochem Biotechnol. 2011 Mar;163(6):693-706. Epub 2010 Sep 5; IDS filed on 01/14/2025) in view of Accession O31193 (01-JAN-1998; IDS filed on 01/14/2025), Accession Q8U0C9 (01-JUN-2002; IDS filed on 01/14/2025).
Cheng et al. teach amylolytic yeast strain for alcoholic beverage production and brewing of alcoholic beverages is performed by fermentation using starchy materials where various kinds of enzymes in rice koji and wheat koji including α-amylase, glucoamylase, and acid protease which are able to participate in breaking down starchy materials into simple sugars and other components that yeast can use to ferment (see entire publication especially pages 700-705).
Accession O31193 teaches the Bacillus stearothermophilus alpha amylase comprising an amino acid sequence that is 100% identical to SEQ ID NO: 1 (see attached alignment).
Accession Q8U0C9 teaches the Pyrococcus furiosus protease comprising an amino acid sequence that is 100% identical to SEQ ID NO: 13 (see attached alignment).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to arrive at the claimed invention by formulating a composition comprising the Bacillus stearothermophilus alpha amylase of Accession O31193, Pyrococcus furiosus protease of Accession Q8U0C9, glucoamylase, pullulanase. One of ordinary skill in the art would have been motivated to do this in order to composition comprising glucoamylase, and acid protease which would be used in breaking down starchy materials into simple sugars and other components that yeast can use to ferment for alcoholic beverage production as taught by Cheng et al. One of ordinary skill in the art at the time the invention was made would have a reasonable expectation of success because making compositions comprising enzymes and using the compositions to make fermentation products are well known in the art. Thus, the claimed invention was within the ordinary skill in the art to make and use at the time the invention was made, and was as a whole clearly prima facie obvious.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 15-29 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 12227785 (02/18/2025; PTO 892). Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons.
The claims and/or the specification of the patent teach a composition comprising an alpha-amylase and a protease, wherein the i) alpha- amylase has a T2 (min) at pH 4.5, 85°C, 0.12 mM CaCI2) of at least 10; ii) protease having a thermostability value of more than 20% determined as Relative Activity at 80°C/70°C. Thus, the teachings anticipate the claimed invention.
Claims 15-29 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11840718 (12/12/2023; PTO 892). Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons.
The claims and/or the specification of the patent teach a composition comprising an alpha-amylase and a protease, wherein the i) alpha- amylase has a T2 (min) at pH 4.5, 85°C, 0.12 mM CaCI2) of at least 10; ii) protease having a thermostability value of more than 20% determined as Relative Activity at 80°C/70°C. Thus, the teachings anticipate the claimed invention.
Claims 15-29 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-45 of U.S. Patent No. 11499170 (11/15/2022; PTO 892). Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons.
The claims and/or the specification of the patent teach a composition comprising an alpha-amylase and a protease, wherein the i) alpha- amylase has a T2 (min) at pH 4.5, 85°C, 0.12 mM CaCI2) of at least 10; ii) protease having a thermostability value of more than 20% determined as Relative Activity at 80°C/70°C. Thus, the teachings anticipate the claimed invention.
Claims 15-29 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-119 of U.S. Patent No. 11566266 (01/31/2023; PTO 892). Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons.
The claims and/or the specification of the patent teach a composition comprising an alpha-amylase and a protease, wherein the i) alpha- amylase has a T2 (min) at pH 4.5, 85°C, 0.12 mM CaCI2) of at least 10; ii) protease having a thermostability value of more than 20% determined as Relative Activity at 80°C/70°C. Thus, the teachings anticipate the claimed invention.
Claims 15-29 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 9816112 (11/14/2017; PTO 892). Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons.
The claims and/or the specification of the patent teach a composition comprising an alpha-amylase and a protease, wherein the i) alpha- amylase has a T2 (min) at pH 4.5, 85°C, 0.12 mM CaCI2) of at least 10; ii) protease having a thermostability value of more than 20% determined as Relative Activity at 80°C/70°C. Thus, the teachings anticipate the claimed invention.
Claims 15-29 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-47 of U.S. Patent No. 10947567 (03/16/2021; PTO 892). Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons.
The claims and/or the specification of the patent teach a composition comprising an alpha-amylase and a protease, wherein the i) alpha- amylase has a T2 (min) at pH 4.5, 85°C, 0.12 mM CaCI2) of at least 10; ii) protease having a thermostability value of more than 20% determined as Relative Activity at 80°C/70°C. Thus, the teachings anticipate the claimed invention.
Claims 15-29 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-114 of U.S. Patent No. 10941422 (03/09/2021; PTO 892). Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons.
The claims and/or the specification of the patent teach a composition comprising an alpha-amylase and a protease, wherein the i) alpha- amylase has a T2 (min) at pH 4.5, 85°C, 0.12 mM CaCI2) of at least 10; ii) protease having a thermostability value of more than 20% determined as Relative Activity at 80°C/70°C. Thus, the teachings anticipate the claimed invention.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Christian L Fronda whose telephone number is (571)272 0929. The examiner can normally be reached Monday-Thursday and alternate Fridays between 9:00AM-5:00PM.
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/CHRISTIAN L FRONDA/Primary Examiner, Art Unit 1652
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