DETAILED ACTION
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 .
Priority
The present application, filed on 04/14/2023, has a U.S. provisional application 63/331,601 filed on 04/15/2022, claiming priority over the provisional application.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01/12/2024 was filed after the mailing date of the present application on 04/14/2023. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Status of Claims
Claims 1-20 filed on 04/14/2023 are pending and are examined under the merits herein.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 1-10 and 11-20 are rejected under 35 U.S.C. 103 as being unpatentable over US PGPUB US 2020/025503 A1, published on 08/13/2020 (herein referred to as Orengo 2020) and in view of Eckl-Dorna et al., 2019 (Eckl-Dorna J, et al. Allergen-Specific Antibodies Regulate Secondary Allergen-Specific Immune Responses. Front Immunol. 2019 Jan 17;9:3131. doi: 10.3389/fimmu.2018.03131).
Regarding instant claims 1, 5, 11, and 15, Orengo 2020 teaches a method and composition for allergy treatment, the composition comprising: an IgG antibody that binds to an epitope of a cat allergen Fel D1, to promote clearance or to block the binding of the allergen to pre-formed IgE on the surface of mast cells or basophils thereby reducing side effects of a patient in sensitized to cat allergens (page 2, paragraph 0012, “antibodies of the invention may prevent the release of histamine or other inflammatory mediators from mast cells or basophils, thereby preventing or diminishing the untoward effects observed in patients sensitized to the cat allergen” and page 3, paragraph 0036, "isolated human antibody or antigen-binding fragment thereof that binds specifically to Fel d1 has an isotype selected from the group consisting of an IgG1, an IgG2 and an IgG4”) and Orengo further teaches an anti-IgE antibody as the second therapeutic agent (page 10, paragraph 0167 "In one embodiment, the invention features a composition, which is a combination of a therapeutically effective amount of one or more anti-Fel d1 antibodies or antigen-binding fragments thereof of the invention, and a therapeutically effective amount of a second therapeutic agent" and page 3, paragraph 0030, "second therapeutic agent is selected from the group consisting of […] an anti-IgE antibody").
However, Orengo 2020 does not teach omalizumab which is the anti-IgE antibody that inhibits binding to a high affinity Fc[Symbol font/0x65]RI receptor but does not eliminate circulating IgE. Eckl-Dorna et al., 2019 teaches omalizumab which blocks binding to high affinity Fc[Symbol font/0x65]RI and can reduce serum levels of free IgE by 95% (page 8, column 2, paragraph 2, “Omalizumab is a monoclonal anti-IgE antibody binding to the constant region 3 of IgE and hence inhibits binding of IgE to its receptors Fc[Symbol font/0x65]RI and CD23. Treatment with omalizumab reduces levels of free serum IgE by 95% and leads to reduced exacerbations and corticosteroid use in asthmatic patients”). Eckl-Dorna et al., 2019 discloses that allergen-specific IgE and IgG antibodies are important in regulating allergen-specific T cell responses (page 11, column 1, paragraph 2, “The observation that there is a cumulative effect of both AIT and omalizumab treatment on FAB especially after discontinuation of the treatment (124) supports the hypothesis that both allergen-specific IgE and IgG antibodies are important in regulating allergen-specific T cell responses.”).
Therefore, it would have been obvious to the person of ordinary skill in the art to combine the allergen-specific lgG to reduce unwanted side effects in sensitized patients as taught by Orengo et al., 2030 and the anti-IgE antibody omalizumab as taught by Eckl-Dorna et al., 2019 to reduce side effects while inducing regulating allergen-specific T cell responses.
Regarding instant claims 2-4 and 12-14, Orengo 2020 teaches that the allergy treated is a hypersensitivity reaction wherein the allergy treated is an anaphylactoid type I hypersensitivity reaction (page 17, paragraph 0247, "Immunoglobulin E (IgE) is responsible for type 1 hypersensitivity") and the anaphylaxis is due to exposure to a food, animal, or environmental allergen (page 2, paragraph 0018, "In any of the methods described herein, the allergen may be selected from an animal product, a food allergen, plant pollen, mold spores, house dust mites, cockroaches, perfume, detergents, household cleaners, latex, a drug product, or insect venom").
Regarding instant claims 6-8 and 16-18, Eckl-Dorna et al., 2019 teaches omalizumab wherein the omalizumab can reduce circulating IgE by more than 95% (page 8, column 2, paragraph 2).
Regarding instant claims 9, 10, 19 and 20, Orengo 2020 teaches that the IgG antibody and anti-IgE are contained within one dosage form (page 27, paragraph 0330, "Advantageously, the pharmaceutical compositions for oral or parenteral use described above are prepared into dosage forms in a unit dose suited to fit a dose of the active ingredients ") and the IgG antibody and anti-IgE antibody are provided to the subject in separate dosage forms (page 10, paragraph 0171, " It will also be appreciated that the antibodies and pharmaceutically acceptable compositions of the present invention can be employed in combination therapies, that is, the antibodies and pharmaceutically acceptable compositions can be administered concurrently with, prior to, or subsequent to, one or more other desired therapeutics or medical procedures").
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Lam Thuy Vi Tran Ho whose telephone number is (571)272-9135. The examiner can normally be reached Monday-Friday 7:30-4.
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/LAM THUY VI TRAN HO/Examiner, Art Unit 1647 /L.T.//JOANNE HAMA/Supervisory Patent Examiner, Art Unit 1647