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 .
DETAILED ACTION
Application Status
This application is a 371 of PCT/CN2021/139046, filed on 06/15/2023.
Claims 74-93 are currently pending.
The preliminary amendment filed on 03/04/2026, amending claim 88, and canceling claims 1-73 is acknowledged.
Election/Restriction
Applicant's election with traverse of Group I, Claims 74, 75-77, 78-79, and 80, drawn to a method for increasing starch yield and/or gluten yield from corn kernels in a wet milling process, the method comprising contacting ground a fiber rich fraction of ground corn kernels with an effective amount of a polypeptide that catalyzes changes in protein disulfide bonds selected from the group consisting of oxidation, reduction, and isomerization, using PDI, and SEQ ID NO: 1 as species, in the response filed on 03/04/2026 is acknowledged.
Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.03(a)).
Applicants request for rejoinder is noted. However, current claims of elected Group I are not allowable at this time. When Group I would be allowable, rejoinder request would be evaluated at that time.
Claims 74-79 and 80 read on elected species and election and restriction requirement.
Claims 81, 82-93 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
The requirement is still deemed proper and is therefore made FINAL.
Claims 74-80 are present for examination.
Priority
Acknowledgement is made of applicants claim for foreign priority under 35 U.S.C. 119(a)-(d) to a foreign patent application WIPO PCT/CN2021/139046, filed on 12/17/2020 (EFD) with English translation.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on 03/15/2023, and 09/26/2024 are acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are considered by the examiner. The signed copies of 1449 are enclosed herewith.
Drawings
There are no Drawings with this patent application.
Specification Objections
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (see, pg 3, 4, 7, and 21). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code. See MPEP § 608.01.
Claim Rejections - 35 USC § 112(b)
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.
Claim 78 (depends on claim 74) is 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 pre-AIA the applicant regards as the invention.
Claim 78 recites the phrase “such as” renders the claim(s) indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim Rejections - 35 USC § 112(a)
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.
A. Written Description
Claims 74-80 are rejected under 35 U.S.C. 112(a), 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.
Claims 74-80 are directed to a method for increasing starch yield and/or gluten yield from corn kernels in a wet milling process, the method comprising contacting ground a fiber rich fraction of ground corn kernels with an effective amount of a polypeptide that catalyzes changes in protein disulfide bonds selected from the group consisting of oxidation, reduction, and isomerization, using PDI,
The Court of Appeals for the Federal Circuit has held that a “written description of an invention involving a chemical genus, like a description of a chemical species, ‘requires a precise definition, such as by structure, formula [or] chemical name,’ of the claimed subject matter sufficient to distinguish it from other materials.” University of California v. Eli Lilly and Co., 1997 U.S. App. LEXIS 18221, at *23, quoting Fiers v. Revel, 25 USPQ2d 1601, 1606 (Fed. Cir. 1993). To fully describe a genus of genetic material, which is a chemical compound, applicants must (1) fully describe at least one species of the claimed genus sufficient to represent said genus whereby a skilled artisan, in view of the prior art, could predict the structure of other species encompassed by the claimed genus and (2) identify the common characteristics of the claimed molecules, e.g., structure, physical and/or chemical characteristics, functional characteristics when coupled with a known or disclosed correlation between function and structure, or a combination of these (paraphrased from Enzo Biochemical).
Thus, Claims 74-80, are drawn to a method for increasing starch yield and/or gluten yield from corn kernels in a wet milling process, the method comprising contacting ground a fiber rich fraction of ground corn kernels with an effective amount of any polypeptide derived from any sources having no structural feature, that catalyzes changes in protein disulfide bonds selected from the group consisting of oxidation, reduction, and isomerization, using any PDI, derived from any sources having no structural feature, and at least 70% identity to SEQ ID NO: 1 (for claim 80), i.e., 30% non-identity to SEQ ID NO: 1, that encompasses many PDI enzymes derived from many unknown sources and many mutants, variants, and fragments thereof, which can have wide variety of unknown structures, i.e. No Structure-Function correlation, which is required to fulfill the Written Description (WD) requirement.
As discussed in the written description guidelines 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, reduction to drawings, 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. 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.
Furthermore, the genus of polypeptides required in the claimed invention is an extremely large structurally and functionally variable genus. While the argument can be made that the recited genus of polypeptides are adequately described by the disclosure of the structures of prior art. However, the art clearly teaches the “Practical Limits of Function Prediction”: Whisstock et al., (2003) highlight the difficulties associated with “Prediction of protein function from protein sequence and structure”; “To reason from sequence and structure to function is to step onto much shakier ground”, closely related proteins can change function, either through divergence to a related function or by recruitment for a very different function, in such cases, assignment of function on the basis of homology, in the absence of direct experimental evidence, will give the wrong answer, it is difficult to state criteria for successful prediction of function, since function is a vague concept. This finding is reinforced in the following scientific teachings for specific proteins in the art that suggest, even highly structurally homologous polypeptides do not necessarily share the same function and many functionally similar proteins will have little or no structural homology to disclosed proteins. For example, proteins having similar structure have different activities (structure does not always correlate to function); Witkowski et al., (1999) teaches that one conservative amino acid substitution transforms a [Times New Roman font/0x62]-ketoacyl synthase into a malonyl decarboxylase and completely eliminates [Times New Roman font/0x62]-ketoacyl synthase activity. Similarly, the art also teaches that functionally similar molecules have different structures; Kisselev L., (2002) teach that polypeptide release factors in prokaryotes and eukaryotes have same function but different structures.
Furthermore, the genus of polynucleotide encoding polypeptides or variants required in the claimed invention is an extremely large structurally and functionally variable genus. While the argument can be made that the recited genus of polypeptides are adequately described by the disclosure of the structures of prior art, i.e., lipase variant enzymes. However, the art clearly teaches the “Practical Limits of Function Prediction”: Whisstock et al., (2003) highlight the difficulties associated with “Prediction of protein function from protein sequence and structure”; “To reason from sequence and structure to function is to step onto much shakier ground”, closely related proteins can change function, either through divergence to a related function or by recruitment for a very different function, in such cases, assignment of function on the basis of homology, in the absence of direct experimental evidence, will give the wrong answer, it is difficult to state criteria for successful prediction of function, since function is in principle a fuzzy concept. This finding is reinforced in the following scientific teachings for specific proteins in the art that suggest, even highly structurally homologous polypeptides do not necessarily share the same function and many functionally similar proteins will have little or no structural homology to disclosed proteins. For example, proteins having similar structure have different activities (structure does not always correlate to function); Witkowski et al., (1999) teaches that one conservative amino acid substitution transforms a [Times New Roman font/0x62]-ketoacyl synthase into a malonyl decarboxylase and completely eliminates [Times New Roman font/0x62]-ketoacyl synthase activity. Similarly, the art also teaches that functionally similar molecules have different structures; Kisselev L., (2002) teach that polypeptide release factors in prokaryotes and eukaryotes have same function but different structures.
Claims are drawn to very broadly a method for increasing starch yield and/or gluten yield from corn kernels in a wet milling process, the method comprising contacting ground a fiber rich fraction of ground corn kernels with an effective amount of any polypeptide derived from any sources having no structural feature, that catalyzes changes in protein disulfide bonds selected from the group consisting of oxidation, reduction, and isomerization, using any PDI, derived from any sources having no structural feature, and at least 70% identity to SEQ ID NO: 1 (for claim 80), i.e., 30% non-identity to SEQ ID NO: 1, that encompasses many PDI enzymes derived from many unknown sources and many mutants, variants, and fragments thereof, which can have wide variety of unknown structures, i.e. No Structure-Function correlation, whose structures are not fully described in the specification. No information, beyond the characterization of PDI enzymes has been provided, which would indicate that applicants had possession of the claimed genus. The specification does not contain sufficient disclosure of the structure with function of all the variant lipase enzymes, within the scope of the claimed genus. The genus of polypeptides claimed is a large variable genus including many mutants, variant and fragments thereof, which can have wide variety of structures. Therefore, many structurally unrelated enzymes (PDI) within the scope of these claims. The specification discloses the structure of only few representative species of the claimed genus, which is insufficient to put one of skill in the art in possession of the attributes and features of all species within the claimed genus. Therefore, one skilled in the art cannot reasonably conclude that applicant had possession of the claimed invention at the time the instant application was filed.
Applicant is referred to the revised guidelines concerning compliance with the written description requirement of U.S.C. 112, first paragraph, published in the Official Gazette and also available at www.uspto.gov.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
MPEP-2131 Anticipation — Application of 35 U.S.C. 102 [R-08.2017]
A claimed invention may be rejected under 35 U.S.C. 102 when the invention is anticipated (or is "not novel") over a disclosure that is available as prior art. To reject a claim as anticipated by a reference, the disclosure must teach every element required by the claim under its broadest reasonable interpretation. See, e.g., MPEP § 2114, subsections II and IV.
"A claim is anticipated only if each and every element as set forth in the claim is found, either expressly or inherently described, in a single prior art reference." Verdegaal Bros. v. Union Oil Co. of California, 814 F.2d 628, 631, 2 USPQ2d 1051, 1053 (Fed. Cir. 1987). "When a claim covers several structures or compositions, either generically or as alternatives, the claim is deemed anticipated if any of the structures or compositions within the scope of the claim is known in the prior art." Brown v. 3M, 265 F.3d 1349, 1351, 60 USPQ2d 1375, 1376 (Fed. Cir. 2001) Note that, in some circumstances, it is permissible to use multiple references in a 35 U.S.C. 102 rejection. See MPEP § 2131.01.
MPEP-2131.01 Multiple Reference 35 U.S.C. 102 Rejections [R-11.2013]
Normally, only one reference should be used in making a rejection under 35 U.S.C. 102. However, a 35 U.S.C. 102 rejection over multiple references has been held to be proper when the extra references are cited to:
(A) Prove the primary reference contains an "enabled disclosure;"
(B) Explain the meaning of a term used in the primary reference; or
(C) Show that a characteristic not disclosed in the reference is inherent.
Claims 74-79 are rejected under 35 U.S.C. 102(a)(1) based upon a public use or sale or other public availability of the invention as anticipated by Lanahan et al. (Thioredoxin and grain process. WO 2000/36126, publication 06/22/2000, see IDS).
The Broadest Reasonable Interpretation (BRI) of claim 74, which is drawn to a method for increasing starch yield and/or gluten yield from corn kernels in a wet milling process, the method comprising contacting ground a fiber rich fraction of ground corn kernels with an effective amount of any polypeptide derived from any sources having no structural feature, that catalyzes changes in protein disulfide bonds selected from the group consisting of oxidation, reduction, and isomerization, using any PDI, derived from any sources having no structural feature, and at least 70% identity to SEQ ID NO: 1 (for claim 80), i.e., 30% non-identity to SEQ ID NO: 1, that encompasses many PDI enzymes derived from many unknown sources and many mutants, variants, and fragments thereof, which can have wide variety of unknown structures.
Regarding claims 74-79, Lanahan et al. teach an invention that provides methods of processing grain corn and soybeans, utilizing thioredoxin and/or thioredoxin reductase to enhance extractability and recovery of starch and protein, wherein method further provides transgenic plants expressing thermostable thioredoxin and/or thioredoxin reductase hyperthermophilic organism Archaeglobus fulgidus and Methanococcus jannaschii. Lanaham et al. also teach a method to increase efficiency of separation of starch and protein in a grain milling process, by steeping the grain at an elevated temperature in the presence of supplemental thioredoxin and/or thioredoxin reductase and separating the starch and protein components of the grain, wherein the grain includes grain from a transgenic plant wherein the transgene expresses thioredoxin and/or thioredoxin reductase enzyme, wherein the plant is selected from corn (Zea mays) and soybean, comprising a heterologous DNA sequence coding for a thioredoxin and/or thioredoxin reductase stably integrated into its nuclear or plastid DNA, wherein the thioredoxin and/or thioredoxin reductase is thermostable, wherein the thioredoxin and/or thioredoxin reductase is selected from the group consisting of SEQ ID NO: 1 , SEQ ID NO: 2, SEQ ID NO: 3, SEQ ID NO: 4, SEQ ID NO: 5, SEQ ID NO: 6, and SEQ ID NO: 7, wherein the plant is selected from corn and soybean, and a plant expressible expression cassette comprising a coding region for a thioredoxin and/or thioredoxin reductase operably linked to promoter and terminator sequences which function in a plant, wherein the thioredoxin and/or thioredoxin reductase is thermostable, wherein the thioredoxin and/or thioredoxin reductase is selected from the group consisting of SEQ ID NO: 1, SEQ ID NO: 2, SEQ ID NO: 3, SEQ ID NO: 4, SEQ ID NO: 5, SEQ ID NO: 6, and SEQ ID NO: 7. Lanaham et al. further teach a method of producing grain comprising high levels of thioredoxin and/or thioredoxin reductase comprising transforming plants with an expression cassette, and a method of producing grain comprising high levels of thioredoxin and/or thioredoxin reductase comprising pollinating a first plant comprising a heterologous expression cassette comprising a transactivation-regulated promoter regulated and operably linked to a DNA sequence coding for a thioredoxin and/or thioredoxin reductase, with pollen from a second plant comprising a heterologous expression cassette comprising a promoter operably linked to a DNA sequence coding for a trans activator capable of regulating said trans activator-regulated promoter; and recovering grain from the plant thus pollinated, and a method of use of plants or plant material as animal feed.
The limitations i) reduction recited in claim 74, ii) EC 5.3.4.1 recited in claim 75, mg amount of starch or gluten recited in claim 77, amount of protein release per gram dry solids recited in claim 78, are the inherent property of the PDI or Thioredoxin reductase polypeptide of Lanahan et al.
Because the PDI or Thioredoxin reductase polypeptide of the claimed invention and that of recombinant microorganism of the reference is one and the same, Examiner takes the position that the limitations of claims 74, 75, 77, and 78 are inherently associated with the PDI or Thioredoxin reductase polypeptide for producing starch from corn of Lanaham et al. Since the Office does not have the facilities for examining and comparing applicants' polypeptides for producing starch from corn the prior art, the burden is on the applicant to show a novel or unobvious difference between the claimed product and the product of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald et al., 205 USPQ 594.
While claims 74, 76, 77-79 recite products (degraded starch) in product by process form, patentability of a product by process claim is determined by the characteristics, of the product only. As there is no evidence that the degraded starch molecules product as recited in claims 77-79 would be any different from the degraded starch molecules recited by the Lanahan et al. see, MPEP 2113:
2113 Product-by-Process Claims [R-08.2017]
I. PRODUCT-BY-PROCESS CLAIMS ARE NOT LIMITED TO THE MANIPULATIONS OF THE RECITED STEPS, ONLY THE STRUCTURE IMPLIED BY THE STEPS
“[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.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985)
Therefore, Lanaham et al. anticipate claims 74-79 of the instant application as written.
Conclusion
Status of the claims:
Claims 74-81 are rejected.
Claim 80 is free of prior art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IQBAL H CHOWDHURY whose telephone number is (571)272-8137. The examiner can normally be reached on M-F, at 9:00-5:00 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Manjunath N. Rao, can be reached on 571-272-0939. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Iqbal H. Chowdhury, Primary Patent Examiner
Art Unit 1656 (Recombinant Enzymes and Protein Crystallography)
US Patent and Trademark Office
Ph. (571)-272-8137 and Fax (571)-273-8137
/IQBAL H CHOWDHURY/
Primary Examiner, Art Unit 1656
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