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 .
DETAILED ACTION
ELECTION RESPONSE
The Election filed 5/5/2026 in response to the Office Action 2/5/2026 is acknowledged. Applicant elected with traverse Group I (claims 1, 11, 13, 17, 19, 22-27, and 37). Examiner rejoined all claims, including the method claims of Group II (claims 30-34). Claims 1, 11, 13, 17, 19, 22-27, 30-34 and 37 are currently under prosecution.
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 30-34 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 treating or preventing abnormal uterine bleeding (AUB) and dysmenorrhea, and treating leiomyoma or endometriosis, does not reasonably provide enablement for preventing leiomyoma or endometriosis. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
BREADTH OF THE CLAIMS: The claims are drawn to a method of treating or preventing abnormal uterine bleeding (AUB), dysmenorrhea, leiomyoma, or endometriosis comprising administration of the isolated antibody or antigen-binding fragment to claim 1.
PRESENCE OR ABSENCE OF EXAMPLES: The instant specification discloses that administering an anti-IL11 antibody allows for blood reduction in a mouse model of heavy menstrual bleeding, and inhibited secretion of VEGF-A, which is a known mediator that leads to increased leiomyoma vascularization. The instant specification does not disclose any examples that an anti-IL11 antibody can prevent endometriosis or leiomyomas
STATE OF THE ART: It is well known in the art that endometriosis cannot be completely prevented because the cause of endometriosis is not known. (see Schäfer, S.D. (2022). Prevention of Endometriosis: Is It Possible?. In: Oral, E. (eds) Endometriosis and Adenomyosis. Springer, Cham) With regards to leiomyomas, Styer et al (Best Practice & Research Clinical Obstetrics and Gynaecology 34 (2016) 3e12) teaches that uterine leiomyomas are the most common benign neoplasms in premenopausal women and affect more than 20% of women and the age/onset/genetics all very. It is challenging to determine if a person would be at risk of leiomyomas in order to prevent its occurrence.
PREDICITABILITY: The specification lacks the critical steps necessary in presenting some type of predictable response in a population of hosts deemed necessary to prevent endometriosis and leiomyomas. There is no evidence in the instant application or the art that as noted in the prior that demonstrate that the instantly claimed antibody would prevent its onset in subjects as claimed.
QUANTITY OF EXPERIMENTATION: Undue experimentation would be required to determine that the claimed antibody is administered to which subject that is at risk of endometriosis or leiomyomas. MPEP 2164.01 recites that “The test of enablement is not whether any experimentation is necessary, but whether, if experimentation is necessary, it is undue. In re Angstadt, 537 F.2d 498, 504, 190 USPQ 214, 219 (CCPA 1976)”. The experimentation needed to practice this method is undue and unreasonable as it requires determining whether the claimed antibody prevents as claimed. A person skilled in the art will not be able to use the invention without undue experimentation. (In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988))
Accordingly, the instant claims do not comply with the enablement requirement of §112, since to practice the invention claimed in the patent a person of ordinary skill in the art would have to engage in undue experimentation, with no assurance of success.
Closest Prior Art
The closest prior art made of record is Cook et al (US20200031918 A1; Published 1/30/2020). Cook et al teaches an isolated antibody capable of binding and inhibiting IL-11 mediated signaling. However, Cook et al does not teach that the antibody comprises the instantly claimed sequences.
Conclusion
Status of the claims:
Claims 1, 11, 13, 17, 22-27 and 37 are allowed.
Claims 19 and 30-34 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH A ALSOMAIRY whose telephone number is (571)272-0027. The examiner can normally be reached Monday-Friday 7:30 AM to 5:30 PM.
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/SARAH A ALSOMAIRY/Examiner, Art Unit 1646
/Zachariah Lucas/Supervisory Patent Examiner, Art Unit 1600
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