DETAILED ACTION
Status of Application
Claims 1-13 are pending.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
A preliminary amendment of claims 2-5 and 7-13 as submitted in a communication filed on 01/31/2024 is acknowledged.
Applicant’s election with traverse of Group I, claims 1-4, 12 and 13, drawn to a modified form of an α-gliadin protein and a food or food product comprising a modified form of an α-gliadin protein, as submitted in communication filed on 04/27/2026 is acknowledged.
Applicant’s traverse is on the grounds that during the international proceedings for this application, all of claims 1-13 were examined in view of the same prior art relied upon in the present restriction requirement without any finding of lack of unity. Applicant’s arguments have been fully considered but not deemed persuasive to withdraw the restriction requirement. Even if the International Search Authority found unity of invention regarding the instant claims, it is noted that according to 37 CFR 1.499, if the Examiner finds that a national stage application lacks unity of invention under 37 CFR § 1.475, the examiner may in an Office action require the applicant in the response to that action to elect the invention to which the claims shall be restricted. Such requirement may be made before any action on the merits but also may be made at any time before the final action at the discretion of the Examiner. It is noted that the claims as previously restricted are directed to three different products and a method for making food products using a protein. Therefore, contrary to Applicant’s assertions, the claims are not drawn to any one of the categories set forth in 37 CFR 1.475(b). In addition, as set forth in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept. It is reiterated herein that the according to PCT Rule 13.2, unity of invention exists only when the share same or corresponding special technical feature is a contribution over the prior art. As indicated in the restriction requirement of 2/27/2026, the technical feature shared by the different inventions is a variant of an α-gliadin protein from T. aestivum with reduced immunogenicity by mutation which is shown by Ofran et al. to lack novelty or inventive step. The technical feature does not make a contribution over the prior art and the claimed inventions do not meet the requirement of unity of invention under PCT Rule 13.2. The restriction is deemed proper and therefore is made FINAL.
Claims 5-11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 04/27/2026.
Claims 1-4,12 and 13 are at issue and will be examined to the extent they encompass the elected invention.
Priority
Acknowledgment is made of a claim for foreign priority under 35 U.S.C. 119(a)-(d) to ITALY 102021000021194 filed on 08/04/2021. Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file.
This is the US national application which entered the national stage from
Application No. PCT/IB2022/056735 filed on 07/21/2022.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 01/31/2024
are acknowledged. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Drawings
The drawings submitted on 01/31/2024 have been reviewed and are accepted by
the examiner for examination purposes.
Claim Objections
Claim 12 is objected to due to the recitation of “a processed food product comprising modified α-gliadin”. It should be amended to recite “a processed food product comprising the modified α-gliadin”. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b) or Second Paragraph (pre-AIA )
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 1-4 and 12-13 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 (claims 2-4, 12-13 dependent thereon) is indefinite in the recitation of “comprising amino acid substitutions in at least 80% of positions 13, 18….232, 240 of the sequence of the predominant mature form, without singal peptide of gliadin of Triticum aestivum (UniProtK – P02863) and having sequence SEQ ID NO: 1” for the following reasons. There is no “and” between “232” and “240”. In addition, as written, it is unclear as to what comprises SEQ ID NO: 1 and if the positions recited refer to positions within SEQ ID NO: 1. Please note that as written, it appears as if the positions recited are those of the sequence of the predominant mature form, without signal peptide, of α- gliadin of T. aestivum (UniProtK P02863) and not necessarily positions within SEQ ID NO: 1. Also, it is unclear as to which is the predominant mature form of α- gliadin of T. aestivum. It should be noted that UniProtK P02863 does not comprise SEQ ID NO: 1 as shown in the alignment below. Therefore, it is uncertain as to how UniProtK P02863 further limits the claim or how it is associated with SEQ ID NO: 1. For examination purposes, it will be assumed that the claim is directed to a protein that is a variant of SEQ ID NO: 1, wherein said protein has substitutions in at least 80% of the positions that correspond to positions 13, 18…and 240 of the polypeptide of SEQ ID NO: 1. Correction is required.
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Claims 1-4 (claims 12 and 13 dependent thereon) are indefinite due to the recitation of “predominant mature form” for the following reasons: It is unclear because the term is not well-defined in the art or specification, making it unclear which protein would meet the limitation. For examination purposes, no patentable weight will be given to the term “predominant mature form”. Correction is required.
Claims 1-2 (claims 3-4 and 12-13 dependent thereon) are indefinite due to the recitation of “without signal peptide” for the following reasons: It is unclear because the term it lacks objective boundaries (i.e. What is the signal peptide?), making it unclear which protein would meet the limitation. For examination purposes, no patentable weight will be given to the term “without signal peptide”. Correction is required.
Claim 2 (claims 3-4 dependent thereon) is indefinite in the recitation of “comprising the amino acid substitutions at positions 13, 18,….232, 240 of the sequence…and having sequence SEQ ID NO: 1” for the following reasons. There is no “and” or “or” between “232” and “240”. Therefore, it is unclear if all of the recited positions are required, or if only one of them is required. In addition, as written, it is unclear as to what comprises SEQ ID NO: 1 and if the positions recited refer to positions within SEQ ID NO: 1. Please note that as written, it appears as if the positions recited are those of the sequence of the predominant mature form, without signal peptide, of α- gliadin of T. aestivum and not necessarily positions within SEQ ID NO: 1. Also, it is unclear as to which is the predominant mature form of α- gliadin of T. aestivum. For examination purposes, it will be assumed that claim 2 is a duplicate of claim 1 as interpreted above. Correction is required.
Claim 3 (claim 4 dependent thereon) is indefinite in the recitation of “wherein from 50 to 70% of the substitutions are conservative…with respect to the sequence of the predominant form of …of Triticum…” for the following reasons. There are 36 substitutions recited in claim 2. As such, 70% of the substitutions correspond to 25.2 substitutions (25.2 = 0.7*36). Since one cannot have decimal numbers of substitutions, one cannot have 70% of substitutions. In addition, as written, it is unclear if “the sequence of the predominant form…aestivum” is SEQ ID NO: 1. Also, it is unclear as to which is the predominant mature form of α- gliadin of T. aestivum. For examination purposes, it will be assumed that claim 3 is a duplicate of claim 1 as interpreted above. Correction is required.
Claim 4 is indefinite in the recitation of “wherein 64% of the substitutions are conservative …with respect to the sequence of the predominant form of…aestivum” for the following reasons. There are 36 substitutions recited in claim 2. As such, 64% of the substitutions correspond to 23.04 substitutions (23.04 = 0.64*36). Since one cannot have decimal numbers of substitutions, one cannot have 64% of substitutions. In addition, as written, it is unclear if “the sequence of the predominant form…aestivum” is SEQ ID NO: 1. Moreover, it is unclear as to which is the predominant mature form of α- gliadin of T. aestivum. For examination purposes, it will be assumed that claim 4 is a duplicate of claim 1 as interpreted above. Correction is required.
Claim 12 (claim 13 dependent thereon) is indefinite in the recitation of “detoxified or with reduced toxicity for celiac subjects” for the following reasons. First, it is unclear as to what is detoxified or with reduced toxicity for celiac subjects, the food/food product or the α-gliadin protein of claim 1. In addition, one cannot determine what should be present or lacking in a food/food product so that one could establish if it is “detoxified”. For examination purposes, no patentable weight will be given to the term “detoxified…for celiac subjects”. Correction is required.
Claim Rejections - 35 USC § 112(a) or First Paragraph (pre-AIA )
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.
Claims 1-4,12 and 13 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.
As stated in MPEP 2111.01, during examination, the claims must be interpreted as broadly as their terms reasonably allow.
Claims 1-4 and 12-13 are directed in part to a genus of variants of the polypeptide of SEQ ID NO: 1 having any structure, wherein said variants have substitutions in at least 80% of positions corresponding to positions 13, 18…and 240 of the polypeptide of SEQ ID NO: 1. See claim rejections under 35 usc 112(b) for claim interpretation.
In University of California v. Eli Lilly & Co., 43 USPQ2d 1938, 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”. As indicated in MPEP § 2163, 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 that Applicant was in possession of the claimed genus. In addition, MPEP § 2163 states that 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.
While the specification in the instant application discloses substitution positions for the variants of the polypeptide of SEQ ID NO: 1, it provides no clue as to the structural elements or amino acid substitutions required in any variant of the polypeptide of SEQ ID NO: 1. Please note that the polypeptides encompass any polypeptide variant of SEQ ID NO: 1 with substitutions in at least 80% of positions corresponding to positions 13, 18…and 240 t. No disclosure of a structure/function correlation has been provided which would allow one of skill in the art to recognize which variants of the polypeptide of SEQ ID NO: 1 have a structure/function correlation that would allow one of skill in the art to determine which substitutions are required in the variants of SEQ ID NO: 1.
Due to the fact that the specification only discloses the substitution positions for the variants of the polypeptide of SEQ ID NO: 1, one of ordinary skill in the art would not recognize from the disclosure that Applicant was in possession of the claimed invention.
Claims 1-4 and 12-13 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for the polypeptide of SEQ ID NO: 1, does not reasonably provide enablement for variants of the polypeptide of SEQ ID NO: 1 having any structure, wherein said variants have substitutions in at least 80% of positions corresponding to positions 13, 18…and 240 of the polypeptide of SEQ ID NO: 1. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
Factors to be considered in determining whether undue experimentation is required are summarized in In re Wands (858 F.2d 731, 737, 8 USPQ2nd 1400 (Fed. Cir. 1988)) as follows: 1) quantity of experimentation necessary, 2) the amount of direction or guidance presented, 3) the presence and absence of working examples, 4) the nature of the invention, 5) the state of prior art, 6) the relative skill of those in the art, 7) the predictability or unpredictability of the art, and 8) the breadth of the claims. The factors which have led the Examiner to conclude that the specification fails to teach how to make and/or use the claimed invention without undue experimentation, are addressed in detail below.
The breadth of the claims. Claims 1-4 and 12-13 broadly encompass variants of the polypeptide of SEQ ID NO: 1, having any structure and function, wherein said variants have substitutions in at least 80% of positions corresponding to positions 13, 18…and 240 of the polypeptide of SEQ ID NO: 1. The enablement provided is not commensurate in scope with the claims due to the lack of knowledge regarding the structure of the variants of the recited polypeptide that can act as an α-gliadin protein. In the instant case, the specification enables the polypeptide of SEQ ID NO: 1.
The amount of direction or guidance presented and the existence of working examples. The specification discloses the polypeptide of SEQ ID NO: 1 and substitution positions for variants of SEQ ID NO: 1. However, the specification fails to provide any clue as to the structural elements required in any variant of the polypeptide of SEQ ID NO: 1, having any structure and function, wherein said variants have substitutions in at least 80% of positions corresponding to positions 13, 18…and 240 of the polypeptide of SEQ ID NO: 1. No correlation between structure and function has been presented.
The state of prior art, the relative skill of those in the art, and the predictability or unpredictability of the art. The structure of an agent determines its structural and functional properties. While the art discloses a limited number of α-gliadin variants, neither the specification nor the art provides a correlation between structure and function such that one of skill in the art can envision the structure of any variants of the polypeptide of SEQ ID NO: 1 that have substitutions at the recited positions that act as α-gliadin. The art clearly teaches that amino acid substitutions change the function of the polypeptide. For example, Ryding et al. (News-Medical. Retrieved on May 26, 2026) teaches that acid replacement can be deleterious, neutral, or beneficial (Page 1, paragraph 1). The art clearly teaches that amino acid substitutions may unpredictably alter protein folding and function. For example, Shortle et al. (Proceedings of the National Academy of Sciences 106.50 (2009): 21011-21012.) teach that a single amino acid substitution can change the fold of a protein (page 21011, left column, first paragraph).
The quantity of experimentation required to practice the claimed invention based on the teachings of the specification. While methods of determining polypeptide substitutions and their functions were known in the art at the time of the invention, it was not routine in the art to screen by a trial and error process for an essentially infinite number of polypeptide variants of SEQ ID NO: 1. In the absence of a rational and predictable scheme for selecting which variants of SEQ ID NO: 1 most likely to have the desired functional features, one of skill in the art would have to test an infinite number of variants of the polypeptide of SEQ ID NO: 1, wherein said variants have substitutions in at least 80% of positions corresponding to positions 13, 18…and 240 of the polypeptide of SEQ ID NO: 1.
Therefore, taking into consideration the extremely broad scope of the claim, the lack of guidance, the amount of information provided, the lack of knowledge about a correlation between structure and the desired function, and the high degree of unpredictability regarding substitutions and effects in structure/function, one of ordinary skill in the art would have to go through the burden of undue experimentation in order to practice the claimed invention. Thus, Applicant has not provided sufficient guidance to enable one of ordinary skill in the art to make and use the invention in a manner reasonably correlated with the scope of the claims.
Claim Rejections - 35 USC § 102 (AIA )
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.
Claims 1-4 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Fasano et al. (US20070048801A1 published 03/01/2007; hereby “Fasano”).
Claims 1-4, as interpreted, are directed in part to a modified form of the a-gliadin protein comprising amino acid substitutions at positions 13, 18, 23, 25, 30, 36, 37, 42, 49, 54, 55, 64, 67, 75, 79, 81, 89, 93, 115, 123, 130, 139, 144, 151, 164, 181, 191, 197, 200, 205, 211, 218, 224, 230, 232, and 240 of the sequence of α-gliadin of Triticum aestivum having sequence SEQ ID No. 1.
Fasano teaches an amino acid sequence of alpha/beta-gliadin precursor from Triticum aestivum (NCBI accession no. AAA34280, (SEQ ID NO: 3)) (Page 3; Table 3 [0035]).
It is noted that SEQ ID NO: 1 from the instant case and SEQ NO: 3 from Fasano have 83.7% sequence identity, differing in 36 positions. Compared to SEQ ID NO: 1 from the instant case, SEQ ID NO: 3 from Fasano has 36 amino acid substitutions at positions 13, 18, 23, 25, 30, 36, 37, 42, 49, 54, 55, 64, 67, 75, 79, 81, 89, 93, 115, 123, 130, 139, 144, 151, 164, 181, 191, 197, 200, 205, 211, 218, 224, 230, 232, and 240. See alignment below.
Therefore, the teachings of Fasano anticipate the instant claims as written/interpreted.
RESULT 4
PCT-US06-05414-3
(NOTE: this sequence has 7 duplicates in the database searched)
Sequence 3, PC/TUS0605414
GENERAL INFORMATION
APPLICANT: Fasano, Alessio
APPLICANT: Brownley, Julie
APPLICANT: Vogel, Stefanie N
APPLICANT: Lammers, Karen
APPLICANT: Lu, Ruiliang
TITLE OF INVENTION: CXCR3 IS A GLIADIN RECEPTOR
FILE REFERENCE: 22298.00023
CURRENT APPLICATION NUMBER: PCT/US06,05414
CURRENT FILING DATE: 2006-02-22
PRIOR APPLICATION NUMBER: US 60/653,118
PRIOR FILING DATE: 2005-02-16
PRIOR APPLICATION NUMBER: US 60/741,998
PRIOR FILING DATE: 2005-12-02
NUMBER OF SEQ ID NOS: 23
SEQ ID NO 3
LENGTH: 286
TYPE: PRT
ORGANISM: Triticum aestivum
Query Match 83.7%; Score 1166; Length 286;
Best Local Similarity 86.5%;
Matches 230; Conservative 3; Mismatches 33; Indels 0; Gaps 0;
Qy 1 VRFPVPQLQPQNSSQQQSQEQVGLLQQQQSLGQQQSSPPQQSYPQPQPNPSQLSPLQLQP 60
|||||||||||| |||| |||| |:|||| ||||| |||| |||||| |||| |||||
Db 21 VRFPVPQLQPQNPSQQQPQEQVPLVQQQQFLGQQQPFPPQQPYPQPQPFPSQLPYLQLQP 80
Qy 61 FPQAQLSYSQPQPFPPQQSYSQPQPQYSKPQQSISQQQQQQQQQQQQQQQQQQIGQQILQ 120
||| || ||||||| ||| | |||||||:||| ||||||||||||||||||||| |||||
Db 81 FPQPQLPYSQPQPFRPQQPYPQPQPQYSQPQQPISQQQQQQQQQQQQQQQQQQILQQILQ 140
Qy 121 QQVIPCMDVTLQQHNIAHPRSQVGQQSTYQGLQELCCQHLWQISEQSQCQAIHNVVHAII 180
||:|||||| |||||||| |||| |||||| |||||||||||| ||||||||||||||||
Db 141 QQLIPCMDVVLQQHNIAHGRSQVLQQSTYQLLQELCCQHLWQIPEQSQCQAIHNVVHAII 200
Qy 181 HHQQQKQQQQSSSQVSSQQSLQQYSLGQGSSRPSQQNSQAQGSKQPQQLSQQEEIRNLAK 240
||||||||| ||||| || |||| ||||| |||||| ||||| ||||| | |||||||
Db 201 LHQQQKQQQQPSSQVSFQQPLQQYPLGQGSFRPSQQNPQAQGSVQPQQLPQFEEIRNLAL 260
Qy 241 QTLPAMCNVYIPPYCTIAPFGIFGTN 266
||||||||||||||||||||||||||
Db 261 QTLPAMCNVYIPPYCTIAPFGIFGTN 286
Claims 1-4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Koning et al. (WO2011157806A1 published 12/22/2011; hereby “Koning”).
Claims 1-4, as interpreted, are directed in part to a modified form of the a-gliadin protein comprising amino acid substitutions at positions 13, 18, 23, 25, 30, 36, 37, 42, 49, 54, 55, 64, 67, 75, 79, 81, 89, 93, 115, 123, 130, 139, 144, 151, 164, 181, 191, 197, 200, 205, 211, 218, 224, 230, 232, 240 of the sequence of α-gliadin of Triticum aestivum having sequence SEQ ID No. 1.
Koning discloses α-gliadin 10719-5 (Figure 17) which is the protein aligned below with SEQ ID NO: 1. Koning teaches that α-gliadin is a naturally occurring protein (Page 32, line 5-7). It is noted that the variant of the claims can have any structure so long as it has the required substitutions. The protein of Koning has all the substitutions recited in claim 1 except for position 181. See alignment below.
Therefore, the teachings of Koning anticipate the instant claims as written/interpreted.
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Claims 12-14 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Faltermaier et al. (Journal of the Institute of Brewing 120.1: 1-15 published 01/09/20214; hereby “Faltermaier”), as evidenced by Fasano et al. (US20070048801A1 published 03/01/2007; hereby “Fasano”).
Claims 12-14, as interpreted, are directed in part to a food or a processed food product comprising modified the α-gliadin according to claim 1, wherein the food product is obtained through baking.
Faltermaier teaches that bread wheat (Triticum aestivum) is commonly used in the baking industry (Page 1, abstract).
According to Fasano, SEQ ID NO: 3 is a naturally occurring protein from T. aestivum (NCBI accession no. AAA34280, (SEQ ID NO: 3)) (Page 3; Table 3 [0035]).
Therefore, the teachings of Faltermaier, as evidenced by Fasano, anticipate the instant claims as written/interpreted.
Conclusion
No claim is in condition for allowance.
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/S.L.S./Examiner, Art Unit 1652
/ROBERT B MONDESI/Supervisory Patent Examiner, Art Unit 1652
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