RESPONSE TO APPLICANT’S AMENDMENT
1. Applicant's amendment, filed 01/29/2026, is acknowledged.
2. Claims 55 and 57-97 are pending.
3. Applicant’s IDS, filed 01/29/2026, is acknowledged.
4. The following new grounds of rejection are necessitated by the amendment submitted 01/29/2026.
5. The recitation “M252Y, S254T and T256E” in claim 61 is objected to because there is no structural features (SEQ ID NO) for the referenced amino acids. For Example, claim 62 recited SEQ ID NO: 60 as the IgG1 heavy chain constant region, however positions 252V, 254G and 256Y, which do not correspond to the claimed substitutions. Clarification is required.
7. The following is a quotation of 35 U.S.C. 112(a) (Pre-AIA 35 U.S.C. 112, first paragraph):
(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.
8. Claims 69, 71-76, 82-88, 91-97 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as containing subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Claims are directed to a genus of methods for treat a genus of IgE- mediated disease with the claimed anti-IgE antibodies including asthma, allergic rhinitis and/or allergic sinusitis, chronic urticaria, a subgenus of allergic diseases, a subgenus of food allergies and tropic dermatitis.
The instant claims are drawn to a large genus of methods which have not been developed yet to the point where a specific benefit exists in a currently available from.
Factors to be considered in determining whether undue experimentation is required to practice the claimed invention are summarized In re Wands (858 F2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988)). The factors most relevant to this rejection are the scope of the claim, the amount of direction or guidance provided, the lack of sufficient working examples, the unpredictability in the art and the amount of experimentation required to enable one of skill in the art to practice the claimed invention.
The specification at [0077] discloses that exemplary diseases associated with abnormal level of IgE may include, but are not limited to, bronchial asthma, allergic rhinitis, atopic dermatitis, urticaria, allergic responses, or atopic dermatitis.
The specification fails to treat any disease with the claimed antigen-binding protein, one or more isolated nucleic acid molecules encoding the antigen-binding proteins, vectors comprising the one or more isolated nucleic acid molecules or cells comprising the one or more isolated nucleic acid molecules.
The specification provides no information on the activity of the claimed antigen-binding proteins.
Given the relatively incomplete understanding in correlating between the claimed antigen-binding proteins/ nucleic acid encoding the antigen-binding proteins, vectors and host cells and diseases associated with abnormal levels of IgE, and the lack of a reasonable correlation between the narrow disclosure in the specification and the broad scope of protection sought in the claims, the claims are not enabled. See MPEP 2164.08.
The MPEP states that the issue of "correlation" is also dependent on the state of the prior art. In other words, if the art is such that a particular model is recognized as correlating to a specific condition, then it should be accepted as correlating unless the examiner has evidence that the model does not correlate. Even with such evidence, the examiner must weigh the evidence for and against correlation and decide whether one skilled in the art would accept the model as reasonably correlating to the condition. See MPEP 2164.02.
Regarding in vivo methods which rely on generally unpredictable mechanisms, ''The amount of guidance or direction needed to enable the invention is inversely related to the amount of knowledge in the state of the art as well as the predictability in the art.'' In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). The “amount of guidance or direction'' refers to that information in the application, as originally filed, that teaches exactly how to make or use the invention. The more that is known in the prior art about the nature of the invention, how to make, and how to use the invention, and the more predictable the art is, the less information needs to be explicitly stated in the specification. In contrast, if little is known in the prior art about the nature of the invention and the art is unpredictable, the specification would need more detail as to how to make and use the invention in order to be enabling (MPEP 2164.03).'' The MPEP also states that physiological activity can be considered inherently unpredictable.
Further, in Rasmusson v. SmithKline Beecham Corp., 75 USPQ2d 1297-1303 (CAFC 2005), the court states “If mere plausibility were the test for enablement under section 112, applicants could obtain patent rights to “inventions” consisting of little more than respectable guesses as to the likelihood of their success. When one of the guesses later proved true, the 'inventor' would be rewarded the spoils instead of the party who demonstrated that the method actually worked. That scenario is not consistent with the statutory requirement that the inventor enable an invention rather than merely proposing an unproved hypothesis.”
Reasonable correlation must exist between the scope of the claims and scope of the enablement set forth. In view on the quantity of experimentation necessary the limited working examples, the nature of the invention, the state of the prior art, the unpredictability of the art and the breadth of the claims, it would take undue trials and errors to practice the claimed invention.
Applicant’s arguments, filed 01/29/2026, have been fully considered, but have not been found convincing.
Applicant submits that the instant specification provides ample working examples demonstrating the activities of the claimed antibodies. For example, Examples 2, 5, and 6 show that the claimed anti-IgE antibodies can bind to human IgE CH3-CH4, full-length human IgE, and cynomolgus IgE with high affinity. Examples 8 and 9 demonstrate that the claimed anti-IgE antibodies can block the binding of IgE to FcεRI and CD23. Notably, Examples 10 and 11 illustrate that the claimed anti-IgE antibodies can inhibit IgE-mediated histamine release from cell lines and human whole blood. For example, Example 10 at para. [0245] discloses:
The results are shown in FIG. 4A and FIG. 4B, showing that the antibodies were capable of inhibiting the FL [full-length] hIgE induced histamine release from FcgRI/RBL-2H3 induced, and the IC 50 value is lower than that of omalizumab, indicating that the inhibition effect is superior than that of omalizumab.
Example 11 at para. [0249] states:
The results are shown in FIG. 5, showing that Anti-IgE serum was capable of crosslinking or activating IgE that had bound to FcεRI, and inducing histamine release, while omalizumab, AB 1904A m10 and AB 1904A m15 do not.
Furthermore, the pharmacokinetic (PK) and pharmacodynamic (PD) studies in human
FcRn-humanized mice and cynomolgus monkeys shown in Examples 13 and 14 demonstrate that the claimed anti-IgE antibodies exhibit prolonged serum half-life and sustained suppression of free IgE of the claimed IgE-antibodies as compared to omalizumab. Hence, contrary to the Examiner's allegation, the instant specification provides ample working examples demonstrating the activities of the claimed anti-IgE antibodies. More importantly, the disclosed activities, e.g., the inhibitory effect on IgE-mediated histamine release, sufficiently enable the claimed method of treating an IgE-mediated disease using the claimed anti-IgE antibody or antigen-binding portion.
This is not found persuasive because none of these examples treat the claimed genus of IgE- mediated disease with the claimed anti-IgE antibodies including asthma, allergic rhinitis and/or allergic sinusitis, chronic urticaria, a subgenus of allergic diseases, a subgenus of food allergies and tropic dermatitis.
9. Claims 55 and 57-68, 70, ,77-81 and 89-90 are allowable.
10. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
11. Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAHER M HADDAD whose telephone number is (571)272-0845. The examiner can normally be reached on Monday-Friday from7:00AM to 4:30PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu, can be reached at telephone number 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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March 19, 2026
/MAHER M HADDAD/ Primary Examiner, Art Unit 1644