DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Applicant’s election without traverse of Group III (claims 23-25, 27-28, 30-31 and 34-35) and species of antibody 38B7, SEQ ID NOs: 23, 24, 151, 152, 317-319, 549, DAS and 550 in the reply filed on May 1, 2026 is acknowledged.
3. Claims 1, 13, 23-25, 27-28, 30-31, 34-36, 46, 56, 65, 69-72 and 76 are pending. Claims 2-12, 14-22, 26, 29, 32-33, 37-45, 47-55, 57-64, 66-68, 73-75 and 77-96 are canceled. Claims 1, 13, 36, 46, 56, 65, 69-72 and 76 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on May 1, 2026.
4. Claims 23-25, 27-28, 30-31 and 34-35 are under examination.
Information Disclosure Statement
5. The information disclosure statements (IDS) submitted on 1/9/2025 and 3/16/2025 have been considered by the examiner.
Nucleotide and/or Amino Acid Sequence Disclosures
6. REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," 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 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) 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") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) 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 of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
7. Specific deficiency - The Incorporation by Reference paragraph required by 37 CFR 1.821(c)(1) is missing or incomplete. See item 1) a) or 1) b) above.
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.
8. Specific deficiency – Nucleotide and/or amino acid sequences appearing in the specification are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). see page 64, for example.
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 sequence identifiers, 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
9. Claims 23-25, 27-28, 30-31 and 34-35 are objected to because of the following informalities:
(i) Claim 23 is objected to for reciting “delivering to said subject an IgG antibody or antibody fragment”. The term “delivering” should be changed to “administering”. The term “delivery” means provide, hand over to the subject the antibody. In order to treat the subject, the antibody must be administered to the subject. Furthermore, the term “antibody fragment” should be changed to “antigen binding fragment thereof”. The term “antibody fragment” broadly encompasses any fragments such as an Fc of the antibody.
(ii) Claims 23-25 and 27-28 are objected to for reference to a Table (Tables 1, 2, 3 and 4).
MPEP 2173.05 states "Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table “is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience.” Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (citations omitted).”
Claims 30-31 and 34-35 are objected to as they depend from claim 23.
(iii) Claim 30 is objected to because “a chimeric antibody or a bispecific antibody” is not considered an antibody fragment.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
10. 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.
11. Claim 35 is 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.
Clam 35 depends from a cancelled claim. The metes and bounds of the claimed invention cannot be determined and the claim is indefinite.
Improper Markush Grouping Rejection
12. Claims 23-25, 27-28, 30-31 and 34-35 are rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984).
MPEP 2117 states “Claims that set forth a list of alternatives from which a selection is to be made are typically referred to as Markush claims, after the appellant in Ex parte Markush, 1925 Dec. Comm’r Pat. 126, 127 (1924). Although the term “Markush claim” is used throughout the MPEP, any claim that recites alternatively usable members, regardless of format, should be treated as a Markush claim.”.
A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 706.03(y).
The Markush grouping of the claims (i.e. about 45 antibodies listed in any one of Tables 1-4) is improper because the alternatives defined by the Markush grouping (i.e. antibodies comprising different 6 CDR sequences) are not disclosed in the specification or known in the art to be functionally equivalent and have a common use. Antibodies comprising different 6 CDRs are not functional equivalent because they bind to different epitopes. For example the antibodies can bind to Ara h2, Ara h6, or both Ara h2 and Ara h6, as evidenced by applicant’s Fig. 5A-C. Antibodies that bind to different epitopes will induce different in vivo responses, as evidenced by applicant’s Fig. 5A-C. As such, antibodies comprising different VH CDRs and VL CDRs may not be regarded as functionally equivalent. Furthermore, they do not share both a substantial structural feature and a common use that flows from the substantial structural feature. While the term “antibody” does impart some structure, the structure that is common to antibodies is generally unrelated to antigen-binding function. The 6 CDRs are generally considered to be the region of contact between the antibody and the antigen
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
Claim Rejections - 35 USC § 112
13. 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.
14. Claims 23-25, 27-28, 30-31 and 34-35 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 a method of treating a peanut-related allergic reaction in a subject comprising administering to said subject a peanut antigen specific IgG antibody or an antigen binding fragment thereof, wherein said antibody or antigen binding fragment comprises HCDR1, HCDR2, HCDR3, LCDR1, LCDR2 and LCDR3 sequences of SEQ ID NOs 317-319, 549, DAS and 550, respectively, does not reasonably provide enablement for a method of treating a peanut-related allergic reaction in a subject comprising administering to said subject an RNA, DNA or a vector encoding the peanut antigen specific IgG antibody or antigen binding fragment thereof, and a method of preventing a peanut-related allergic reaction in a subject comprising administering to said subject the peanut antigen specific IgG antibody or antigen binding fragment thereof. 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 or use the invention commensurate in scope with these claims.
Factors to be considered in determining whether a disclosure meets the enablement requirement of 35 USC 112, first paragraph, have been described by the court in In re Wands, 8 USPQ2d 1400 (CA FC 1988). Wands states at page 1404,
''Factors to be considered in determining whether a disclosure would
require undue experimentation have been summarized by the board in Ex
parte Forman. They include (1) the quantity of experimentation necessary,
(2) the amount of direction or guidance presented, (3) the presence or
absence of working examples, (4) the nature of the invention, (5) the state
of the 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 nature of the invention
The claims are drawn to a method of treating or preventing a peanut-related allergic reaction in a subject comprising administering to said subject a peanut antigen specific IgG antibody or antigen binding fragment thereof.
The nature of the invention is treatment and prevention of a peanut-related allergic reaction.
The invention is in a class of invention, which the CAFC has characterized as ''the unpredictable arts such as chemistry and biology.'' Mycogen Plant Sci., Inc. v. Monsanto Co., 243 F.3d 1316, 1330 (Fed. Cir. 2001).
The breadth of the claims and quantity of experimentation
The breadth of the claims encompasses a method of treating a peanut-related allergic reaction in a subject using an RNA, DNA or a vector encoding a peanut antigen specific IgG antibody or antigen binding fragment thereof, and a method of preventing a peanut-related allergic reaction in a subject comprising administering to said subject a peanut antigen specific IgG antibody or antigen binding fragment thereof.
The quantity of experimentation is extremely large in view of the breadth of the claims and the unpredictable nature of gene therapy and prevention of a peanut-related allergic reaction.
The state of the prior art and unpredictability of the art
Regarding in vivo delivery of polynucleotides encoding an antibody, Hollevoet et al. (J Transl Med 2017, 15:131, pages 1-19) teaches that a broad clinical introduction of antibody gene transfer remains littered with challenges. First, it is unclear whether therapeutic mAb titers can be attained and maintained in human subjects. Second, the lack of control on mAb expression can impact safety. Third, immunogenicity against the vector or expressed mAb can limit prolonged expression. Fourth, ongoing innovations in conventional mAb therapy directly compete with antibody gene transfer, potentially impacting the relevance of the latter (page 13,column 1, para 2 ). Different expression platforms and a multitude of administration sites have been pursued. Viral vector-mediated mAb expression thereby made the most significant strides. Therapeutic proof of concept has been demonstrated in mice and nonhuman primates, and intramuscular vectored mAb therapy is under clinical evaluation. However, viral vectors face limitations, particularly in terms of immunogenicity. In recent years, naked DNA has gained ground as an alternative. Attained serum mAb titers in mice, however, remain far below those obtained with viral vectors, and robust pharmacokinetic data in larger animals is limited. The broad translatability of DNA-based antibody therapy remains uncertain, despite ongoing evaluation in patients. RNA presents another emerging platform for antibody gene transfer. Early reports in mice show that mRNA may be able to rival with viral vectors in terms of generated serum mAb titers, although expression appears more short-lived (abstract).
Regarding prevention of a peanut-related allergic person, there is no medication that completely prevents a peanut-allergic person from reacting if they intentionally eat peanuts. There is currently no medicine one can simply take before eating peanuts that guarantees no allergic reaction. Cleveland Clinic (downloaded from website on 5/19/2026) discloses that there’s no specific way to prevent peanut allergies, there are only some strategies to reduce the risk (page 4). Omalizumab (a monoclonal antibody that binds IgE), can reduce your risk of having a reaction if you’re accidentally exposed to peanuts, but you still need to avoid peanuts and foods containing peanuts if you’re using omalizumab (page 3).
Reasonable guidance with respect to preventing a peanut allergic reaction relies on quantitative analysis from defined populations that have been successfully pre-screened and are predisposed to a peanut allergic reaction. The essential element towards the validation of a preventive therapeutic is the ability to test the drug on subjects monitored in advance of a peanut allergic reaction and link those results with subsequent confirmation of the presence or absence of disease. This irrefutable link between antecedent drug and subsequent knowledge of the prevention of the disease is the essence of a valid preventive agent.
All of this underscores the criticality of providing workable examples, particularly in an unpredictable art.
Working example and guidance in the specification
The specification does not provide working examples and guidance on treating a peanut-related allergic reaction using DNA, RNA and vectors encoding an IgG antibody or an antigen binding fragment thereof that binds a peanut antigen.
The specification teaches testing whether isotype switched variant IgG mAbs can be used to block passive systemic anaphylaxis induced in mice. Mice were sensitized using the highly functional set of human IgE antibodies, directed against Ara h 2 ,which fully cross-react with Ara h 6, representing sites CR-A, CR-B, and CR-C (see FIG. 9). Mice were sensitized passively by intraperitoneal (IP) injection with 100 pg total of the purified human IgE mAb(s), with or without IgG blocking antibody, three days prior to challenge. Mice that did not receive any IgG blocking antibody had severe rapid anaphylaxis following challenge with 10% peanut extract, where 5 out of 6 mice died within 25 minutes. When mice received a single IgG blocking mAb specific for CR-A, mice had a slight drop in temperature following peanut challenge, approximately two-degrees at 20 minutes. Mice that received two IgG blocking mAbs, representing CR-A and CR-B, had no significant drop in temperature and exhibited no visible evidence of anaphylaxis following peanut challenge (see page 67, last paragraph).
The specification does not show that a single peanut specific IgG antibody such as 38B7 can completely prevent a peanut-related allergic reaction.
Level of skill in the art
The level of the skill in the art is deemed to be high
Conclusion
Thus given the broad claims in an art whose nature is identified as unpredictable, the large quantity of research required to define these unpredictable variables, and the presence of working examples and guidance in the specification that are not commensurate in scope of the claims, balanced only against the high skill level in the art, it is the position of the examiner that it would require undue experimentation to perform the method of the claims as broadly written.
Conclusion
15. No claims are allowable. The 6 CDRs of the elected antibody 38B7 are free of prior art.
16. Any inquiry concerning this communication or earlier communications from the examiner should be directed to HONG SANG whose telephone number is (571)272-8145. The examiner can normally be reached Monday-Friday 8am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gregory Emch can be reached at 571-272-8149. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HONG SANG/Primary Examiner, Art Unit 1646
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