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 .
2. Applicant’s amendment filed on 07/06/2026 is acknowledged.
3. Claims 1, 4-12 and 14-17 are pending and under consideration for their full scope.
4. The following objection and rejections are necessitated by the amendment filed on 07/06/2026.
5. Claim 12 is objected to because of the following informalities: Claim 12 recites in line “wherein the diseases caused by an increase in eosinophils is” and this is improper grammar.
Appropriate correction is required.
6. 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.
7. Claims 15 and 17 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: an antibody or antigen-binding fragment thereof binding to human IL-5 receptor alpha subunit (IL-5Ra) comprises a heavy-chain CDR1 of SEQ ID NO: 3, a heavy- chain CDR2 selected from the group consisting of SEQ ID NOS: 4, 15 to 18, a heavy-chain CDR3 selected from the group consisting of SEQ ID NOS: 5, 27 to 32, and a light-chain CDR1 of SEQ ID NO: 8, a light-chain CDR2 of SEQ ID NO: 9, and a light-chain CDR3 of SEQ ID NO: 10; wherein the antibody or antigen-binding fragment thereof comprises: a heavy-chain CDR1 of SEQ ID NO: 3, a heavy-chain CDR2 of SEQ ID NO: 4, and a heavy-chain CDR3 of SEQ ID NO: 5, and a light-chain CDR1 of SEQ ID NO: 8, a light-chain CDR2 of SEQ ID NO: 9, and a light-chain CDR3 SEQ ID NO: 10; a heavy-chain CDR1 of SEQ ID NO: 3, a heavy-chain CDR2 of SEQ ID NO: 15, a heavy-chain CDR3 of SEQ ID NO: 5 and a light-chain CDR I of SEQ ID NO: 8, a light-chain CDR2 of SEQ ID NO: 9, and a light-chain CDR3 of SEQ ID NO: 10;a heavy-chain CDR1 of SEQ ID NO: 3, a heavy-chain CDR2 of SEQ ID NO: 16, a heavy-chain CDR3 of SEQ ID NO: 5 and a light-chain CDR I of SEQ ID NO: 8, a light-chain CDR2 of SEQ ID NO: 9, and a light-chain CDR3 of SEQ ID NO: 10;a heavy-chain CDR1 of SEQ ID NO: 3, a heavy-chain CDR2 of SEQ ID NO: 17, a heavy-chain CDR3 of SEQ ID NO: 5 and a light-chain CDR I of SEQ ID NO: 8, a light-chain CDR2 of SEQ ID NO: 9, and a light-chain CDR3 of SEQ ID NO: 10; a heavy-chain CDR1 of SEQ ID NO: 3, a heavy-chain CDR2 of SEQ ID NO: 18, a heavy-chain CDR3 of SEQ ID NO: 5 and a light-chain CDR1 of SEQ ID NO: 8, a light-chain CDR2 of SEQ ID NO: 9, and a light-chain CDR3 of SEQ ID NO: 10; a heavy-chain CDR1 of SEQ ID NO: 3, a heavy-chain CDR2 of SEQ ID NO: 15, a heavy-chain CDR3 of SEQ ID NO: 27 and a light-chain CDR 1 of SEQ ID NO: 8, a light-chain CDR2 of SEQ ID NO: 9, and a light-chain CDR3 of SEQ ID NO: 10; a heavy-chain CDR1 of SEQ ID NO: 3, a heavy-chain CDR2 of SEQ ID NO: 15, a heavy-chain CDR3 of SEQ ID NO: 28 and a light-chain CDR [ of SEQ ID NO: 8, a light-chain CDR2 of SEQ ID NO: 9, and a light-chain CDR3 of SEQ ID NO: 10; a heavy-chain CDR1 of SEQ ID NO: 3, a heavy-chain CDR2 of SEQ ID NO: 15, a heavy-chain CDR3 of SEQ ID NO: 29 and a light-chain CDR I of SEQ ID NO: 8, a light-chain CDR2 of SEQ ID NO: 9, and a light-chain CDR3 of SEQ ID NO: 10; a heavy-chain CDR1 of SEQ ID NO: 3, a heavy-chain CDR2 of SEQ ID NO: 15, a heavy-chain CDR3 of SEQ ID NO: 30 and a light-chain CDR1 of SEQ ID NO: 8, a light-chain CDR2 of SEQ ID NO: 9, and a light-chain CDR3 of SEQ ID NO: 10; a heavy-chain CDR1 of SEQ ID NO: 3, a heavy-chain CDR2 of SEQ ID NO: 15, a heavy-chain CDR3 of SEQ ID NO: 31 and a light-chain CDR1 of SEQ ID NO: 8, a light-chain CDR2 of SEQ ID NO: 9, and a light-chain CDR3 of SEQ ID NO: 10; or a heavy-chain CDR1 of SEQ ID NO: 3, a heavy-chain CDR2 of SEQ ID NO: 15, a heavy-chain CDR3 of SEQ ID NO: 32 and a light-chain CDR1 of SEQ ID NO: 8, a light-chain CDR2 of SEQ ID NO: 9, and a light-chain CDR3 of SEQ ID NO: 10; wherein the antibody or antigen-binding fragment thereof comprises a heavy-chain variable region selected from the group consisting of SEQ ID NOS: 1, 2, 11 to 14, and 21 to 26; wherein the antibody or antigen-binding fragment thereof comprises a light-chain variable region of SEQ ID NO: 6 or 7; nucleic acids encoding, vectors and cells thereof; methods of manufacture; in vitro methods using the antibodies and methods of administering the antibodies, does not reasonably provide enablement for: a method for detecting human IL-5Rα expressing cells in a biological sample whrein the detection of the presence of IL-5Rα expressing cells indicates that the subject has or is suffering from a disease caused by an increased in eosinophils and wherein the disease is hypereosinophilic syndrome (HES), hypereosinophilia, asthma, including eosinophilic asthma, eosinophilic bronchial asthma (ABA) and severe eosinophilic bronchial asthma (ABA), chronic obstructive pulmonary disease (COPD), Churg- Strauss syndrome, eosinophilic esophagitis, eosinophilic gastroenteritis, eosinophilic gastrointestinal disease (EGID), endocardial myocardial fibrosis, Loeffler endocarditis, Davis disease, intermittent angioedema associated with eosinophilia, eosinophilia- myalgia syndrome/Spanish toxic oil syndrome, bullous pemphigoid, acute myelogenous eosinophilic leukemia, acute lymphocytic eosinophilic leukemia, systemic mast cell disease with eosinophilia and eosinophilic vasculitis of claim 15; and wherein the disease caused by an increase in eosinophils is eosinophilic asthma of claim 16.
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 the claims. The specification disclosure does not enable one skilled in the art to practice the invention without an undue amount of experimentation.
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 is not enabled for associating the presence of IL-5Rα expressing cells in a biological sample with any of the diseases recited in claims 15 and 17.
The specification does not disclose any method which results in the use of the antibodies of claim 1 being able to be used to detect the presence of IL-5Rα expressing cells in a biological sample and to associate the presence with any one of the diseases recited in claims 15 and 17. The recited antibodies cannot be used to differentiate any of the diseases recited in claims 15 and 17 from each other or from other diseases or from normal patients which would be a prerequisite to be able to indicate that the subject has or is suffering from any of those diseases. The presence of IL-5Rα expressing cells is not only associated with a particular disease recited in claims 15 and 17, so one cannot say that detection of the presence of IL-5Rα expressing cells in a biological sample indicates that the person has any of the diseases recited in claims 15 and 17. As such one of ordinary skill in the art would be required the perform undue experimentation to make any use the invention commensurate in scope with claims 15 and 17. The specification is not enabled for indicting the presence of disease using the recited antibodies and methods.
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 on 07/06/2026 have been fully considered, but are not found persuasive.
Applicant argues:
“Claims 14, 15, and 17 (Detection method) Are Enabled
Claim 14 is amended to recite, in haec verba, an in vitro method for detecting human IL- 5Ra-expressing cells in a biological sample. The Office expressly acknowledges that the specification is enabling for "in vitro methods using the antibodies." The amended claim is exactly such a method, and Example 21 (spec. [0255]) demonstrates it using the antibodies to detect IL-5Ra on patient granulocytes and to distinguish severe-asthma patients from healthy donors. Because claim 14 no longer recites "diagnosing" a genus of diseases, the Examiner's concerns that the antibody cannot "differentiate" diseases from one another, and that IL-5Ra "is not only associated with" the recited diseases, are moot.
Claim 15 adds that detection of the presence of human IL-5Ra-expressing cells indicates that the subject has, or is suffering from, a disease caused by an increase in eosinophils. This correlation is supported by Example 21 (spec. [0255]), which shows that IL-5Ra-expressing granulocytes distinguish severe-asthma patients from healthy donors, and by paragraphs [0192]- [0193]. Claim 15 requires only detection of IL-5Ra-expressing cells (an enabled in vitro step) and its correlation with an eosinophil-mediated condition; it does not require differential diagnosis among the listed diseases. Claim 16 further specifies that the detection of the presence of human IL-5Ra-expressing cells indicates that the subject has, or is suffering from, eosinophil asthma. Claims 14,15, and 17 are accordingly enabled.”
It is the Examiner’s position that Applicant’s assertion that claim 15 “does not require differential diagnosis among the listed diseases” is not persuasive. The recitation of the particular diseases necessitates differential diagnosis by associating the presence of the cells with the presence of the particular recited diseases made especially clear by the recitation of a single disease recited in claim 17.
The method recites that the detection of IL-5Ra-expressing cells “indicates” that a subject has or is suffering from a disease caused by an increase in eosinophils. The recitation does not encompass other conditions which are associated with increased eosinophils, including parasitic and other infections. So, detection of IL-5Ra-expressing cells could also be associated with infections which are not “caused” by eosinophils. The recited method results in the indication of one of the diseases recited which is not a comprehensive list of diseases caused by an increase in eosinophils nor is it a list of diseases which are associated with increased eosinophils.
Furthermore, and more importantly, the detecting the presence of IL-5Rα -expressing cells in a biological sample is not limited to biological samples from patients with diseases caused by an increase in eosinophils. Eosinophils and basophils of normal patients express IL-5Rα. (See Molfino et al. PTO-892; Reference U) In particular, whole document). The claim does not recite detecting an increased number of cells expressing IL-5Rα over a control value and indicating the presence of disease based upon that value.
The rejection stands for reasons of record.
8. Claims 1 and 4-11 are allowed.
9. 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.
10. Any inquiry concerning this communication or earlier communications from the examiner should be directed to NORA MAUREEN ROONEY whose telephone number is (571)272-9937. The examiner can normally be reached on M-F from 8:00am 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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September 16, 2026
/Nora M Rooney/
Primary Examiner, Art Unit 1641
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