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 .
Status of the Claims
Claims 1, 3 – 13, and 26 – 28 are currently pending and are the subject of this Office Action. This is the first Office Action on the merits of the claims.
Nucleotide and/or Amino Acid Sequence Disclosures
Summary of Requirements for Patent Applications Filed On Or After July 1, 2022, That Have Sequence Disclosures
37 CFR 1.831(a) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.831(b) must contain a “Sequence Listing XML”, as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.831-1.835. This “Sequence Listing XML” part of the disclosure may be submitted:
1. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter “Legal Framework”) in XML format, together with an incorporation by reference statement of the material in the XML file in a separate paragraph of the specification (an incorporation by reference paragraph) as required by 37 CFR 1.835(a)(2) or 1.835(b)(2) identifying:
a. the name of the XML file
b. the date of creation; and
c. the size of the XML file in bytes; or
2. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation by reference statement of the material in the XML format according to 37 CFR 1.52(e)(8) and 37 CFR 1.835(a)(2) or 1.835(b)(2) in a separate paragraph of the specification identifying:
a. the name of the XML file;
b. the date of creation; and
c. the size of the XML file in bytes.
SPECIFIC DEFICIENCIES AND THE REQUIRED RESPONSE TO THIS NOTICE ARE AS FOLLOWS:
Specific deficiency - The incorporation by reference paragraph required by 37 CFR 1.834(c)(1), 1.835(a)(2), or 1.835(b)(2) is missing, defective or incomplete. Specifically, the paragraph under “SEQUENCE LISTING” on page 1 of the specification is missing the size of the XML file in bytes.
Required response - Applicant must:
• Provide a substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required incorporation by reference paragraph, consisting of:
• A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
• A copy of the amended specification without markings (clean version); and
• A statement that the substitute specification contains no new matter.
Claim Objections
Claim 13 is objected to because of the following informalities: the claim depends on itself. Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 27 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim recites assaying a sample from the subject for IgE and/or IgG antibodies that selectively bind one or more mutant peanut polypeptides, wherein a reduction in IgE antibodies and/or an increase in IgG antibodies that selectively bind the one or more mutant peanut polypeptides is an indication that the subject is being desensitized or tolerized to the peanut allergy. This judicial exception is not integrated into a practical application because the claim recites naturally occurring IgE and/or IgG antibodies that selectively bind one or more mutant peanut polypeptides, which may also be naturally occurring polypeptides. The interaction between the antibodies and mutant peanut polypeptides is nothing more than an attempt to generally link products of nature. The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Claim 27 would be classified as “mere data gathering” and do not integrate the judicial exception(s) into a practical application. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception(s). A claim that focuses on judicial exception(s) can be shown to recite something “significantly more” than the judicial exception(s) by reciting a meaningful limitation beyond the judicial exceptions. However, in the instant case, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements (when considered both individually and as an ordered combination) are limited to well-understood, routine and conventional limitations of assaying a sample from the subject for IgE and/or IgG antibodies that selectively bind one or more mutant peanut polypeptides (“Step 2B”). Well-understood, routine and conventional limitations are not meaningful limitations and are not enough to qualify the claimed method as reciting something “significantly more” than the judicial exception(s) (see Part I.B.1 of the interim Guidance).
MPEP 2106.05(d)(II) provides a non-limiting list of laboratory techniques recognized by courts as well-understood, routine, conventional activity. These techniques include:
Determining the level of a biomarker in blood by any means, Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1362, 123 USPQ2d 1081, 1088 (Fed. Cir. 2017).
The recited active steps of the claim impose no meaningful limit on the scope of the claims and are recited at a high level of generality such that substantially all methods of assaying a sample from the subject for IgE and/or IgG antibodies that selectively bind one or more mutant peanut polypeptides would conventionally and routinely perform such steps. The specification discloses that “the disclosed antigens can be used in an immunoassay to capture antibodies capable of binding the disclosed antigens” (specification, page 23, lines 7 – 8). These techniques are well are well-known, routine, and conventional means of assaying a sample from the subject for IgE and/or IgG antibodies that selectively bind one or more mutant peanut polypeptides as evidenced by MATTHEWS (US 2020/0230206 A1, published 07/23/2020; see PTO-892: Notice of References Cited).
MATTHEWS teaches that “[m]ethods of diagnosing peanut allergy are known in the art and include a clinical history of allergic reaction following peanut ingestion, immunological assays (such as measuring peanut-specific IgE (ps-IgE) levels)” (see MATTHEWS at column 8, lines 44 – 48).
The present claims do not contain any significant additional elements or steps beyond the observation of judicial exception(s) present when performing routine and conventional methods. Further, the active method steps are conventional and routine in the art for the reasons stated above and the claims do not amount to significantly more than the judicial exception(s).
Further, just as methods comprising detecting paternal DNA sequences in particular samples by PCR was identified in Ariosa v. Sequenom as "well-known, routine, and conventional" (see first paragraph on page 13 of Ariosa Diagnostics, Inc. v. Sequenom, Inc. (Fed. Cir. 2015)) even though the prior art did not demonstrate detecting said paternal DNA sequences in said particular samples by PCR, the methods identifying which synthetic peptide neoepitopes triggers an immune response encompassed by the instant claims are well-known, routine, and conventional. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements (common methods of detecting expression) are routinely performed in the art to obtain data regarding expression and treat subjects. Also, “[g]roundbreaking, innovative, or even brilliant discovery does not by itself satisfy the § 101 inquiry.” Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107, 2117 (2013).
Thus, the claims do not recite something “significantly more” than the judicial exception(s); rather, the claims “simply inform” the natural phenomenon to one performing routine active method steps and do not amount to significantly more than the judicial exception(s).
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.
Claims 1, 5, 8, 11, and 26 – 28 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The following quotation from section 2163 of the Manual of Patent Examination Procedure (MPEP) is a brief discussion of what is required in a specification to satisfy the 35 U.S.C. 112 written description requirements for a generic claim covering several distinct inventions:
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... See BU 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.
Thus, when a claim covers a genus of inventions, the specification must provide written description support for the entire scope of the genus. Support for a genus is generally found where the applicant has provided a number of examples sufficient so that one in the art would recognize from the specification the scope of what is being claimed.
Claims 1, 5, 8, 11, and 26 – 28 are rejected as lacking adequate descriptive support for the possession of a generic mutant peanut (Arachis hypogaea) Ara h 6 polypeptide. Independent claims 1 and 28 include multiple alternatives for the mutant peanut (Arachis hypogaea) Ara h 6 and Ara h 2 polypeptides, respectively, that have reduced IgE responses. For example, claim 1 recites “wherein the mutant Ara h 6 polypeptide has the amino acid sequence SEQ ID NO:1 with at least 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, or 14 substitutions at amino acid residues T68,Q69, M101, R110, A111, P112, Q113, R114, D104, D118, V119, S120, or a combination thereof.” This limitation results in a large variety of mutant Ara h 6 polypeptides (billions), all of which are not supported by the present specification. The specification presents the sequences of the claims:
SEQ ID NO: 3 (of claim 3), where X at position 113 is not Gln and X at position 114 is not Arg. SEQ ID NO: 3 is further limited to the sequence of SEQ ID NO: 11 in claim 4;
SEQ ID NO: 4 of claim 8, where X at position 90 is not Arg and X at position 91 is not Gln. SEQ ID NO: 4 is further limited to the sequence of SEQ ID NO: 12 in claim 7;
SEQ ID NO: 5 of claim 9, where X at position 90 is not Arg and X at position 91 is not Gln. SEQ ID NO: 5 is further limited to the sequence of SEQ ID NO: 13 in claim 10;
SEQ ID NO: 6 of claim 12, where X at position 33 is not Arg; X at position 56 is not Gln; X at position 99 is not Glu; and X at position 106 is not Gln.
The specification also discloses Ara h 6 with mutations R90E and Q91A in the Examples (specification at p. 26, lines 11 – 14). However, the number of variants supported by the specification is not commensurate in scope with the number of variants that could statistically result from limitations recited in present claims 1, 5, 8, 11, and 26 – 28 .
Furthermore, in Amgen Inc. et al. v. Sanofi et al., 598 U.S. 594, 2023 USPQ2d 602 (2023), the
Supreme Court, held that claims drawn to a genus of monoclonal antibodies, which were functionally claimed by their ability to bind to a specific protein, PCSK9, were invalid due to lack of enablement. The claims at issue were functional, in that they defined the genus by its function (the ability to bind to specific residues of PCSK9) as opposed to reciting a specific structure (the amino acid sequence of the antibodies in the genus). See MPEP 2164.01.
Presently, the claimed mutant peanut (Arachis hypogaea) Ara h 6 (independent claim 1) or Ara h 2 (independent claim 28) polypeptide is only defined by functional properties: its ability to reduce the IgE response in a subject with a peanut allergy compared to wildtype Ara h 6 or 2, respectively. Because as recited, multiple positions on the Ara h 6 or 2 polypeptide can vary significantly, the structure of the Ara h 6 or 2 polypeptide is not specific. Thus, the large variety of structures of Ara h 6 or Ara h 2 polypeptide recited in present claims 1 and 28, respectively, means that just about any structure of Ara h 6 or 2 polypeptide would be able to reduce the IgE response. In view of the fact patterns detailed in Amgen v. Sanofi, Applicant is not in possession of such an Ara h 6 or 2 polypeptide with no specific structure that can reduce IgE response in a subject with a peanut allergy compared to wildtype Ara h 6 or 2 polypeptide as presented by claims 1, 5, 8, 11, and 26 – 28.
Providing SEQ ID NOs for the Ara h 6 and 2 polypeptides that represent specific sequences with each position of the sequence defined with a specific amino acid for claims 1, 5, 8, 11, and 26 – 28 can provide sufficient structures of the claimed Ara h 6 and 2 polypeptides.
Regarding claims 26 – 27, the specification does not disclose “a method for desensitizing or tolerizing a subject with a peanut allergy, comprising administering to the subject the composition of claim 1” as recited in present claim 26 nor does the specification disclose “a method for monitoring progress for the method of claim 26, comprising assaying a sample from the subject for IgE and/or IgG antibodies that selectively bind one or more mutant peanut polypeptides” as recited in present claim 27. The Examples on pages 25 – 26 of the present specification describes analyses of interactions between Ara h 6 proteins and IgE antibodies. No examples of desensitizing or tolerizing a subject with a peanut allergy or monitoring the progress of desensitizing or tolerizing a subject are included in the examples.
In view of this uncertainty and the lack of a representative number of examples of the claimed genus, the claims are rejected for lack of adequate written description support.
Allowable Subject Matter
Claims 3 – 4, 6 – 7, 9 – 10, and 12 are objected to as being dependent upon a rejected base claim but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Regarding claim 3, the prior art does not teach the sequence of SEQ ID NO: 3, where X in position 113 is not Q and X in position 114 is not R. Furthermore, the prior art does not teach the sequence of SEQ ID NO: 3 that is further limited to the sequence of SEQ ID NO: 11 in present claim 4.
Regarding claim 6, the prior art does not teach the sequence of SEQ ID NO: 4, where X in position 90 is not R and X in position 91 is not Q. Furthermore, the prior art does not teach the sequence of SEQ ID NO: 4 that is further limited to the sequence of SEQ ID NO: 12 in present claim 7.
Regarding claim 9, the prior art does not teach the sequence of SEQ ID NO: 5, where X in position 90 is not R and X in position 91 is not Q. Furthermore, the prior art does not teach the sequence of SEQ ID NO: 5 that is further limited to the sequence of SEQ ID NO: 13 in present claim 10.
Regarding claim 12, the prior art does not teach the sequence of SEQ ID NO: 6, where X in position 33 is not R, X in position 56 is not Q, X in position 99 is not E, X in position 106 is not Q.
Conclusion
Claims 1, 5, 8, 11, and 26 – 28 are rejected, and claims 3 – 4, 6 – 7, 9 – 10, and 12 – 13 are objected to.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Estella Gustilo whose telephone number is (703)756-1706. The examiner can normally be reached Monday - Friday 9:30 AM - 5:30 PM.
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/ESTELLA M. GUSTILO/Examiner, Art Unit 1646
/PETER J REDDIG/Primary Examiner, Art Unit 1646
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