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
Status of Application, Amendments, and/or Claims
1. Claims 5-19 are pending and currently under consideration.
Information Disclosure Statement
2. The information disclosure statement filed on 07/24/2025, 06/30/2025, 02/10/2025, 01/17/2025, 12/06/2024, 07/25/2024, 05/30/2024, 04/02/2024, 03/25/2024, 12/12/2023, and 12/01/2023 has been considered by the Examiner and an initialed copy of the form PTO-1449 is attached to this communication.
Drawings
3. The drawings filed on 05/24/2023 are accepted by the examiner.
Claim Rejections[Symbol font/0xBE]35 USC § 112 (a)
4. The following is a quotation of the first paragraph of 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.
5. Claims 5-10 and 14-16 are rejected under 35 U.S.C. 112(a), as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor at the time the application was filed, had possession of the claimed invention.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116. To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof.
Claims 5-10 and 14-16 are drawn to a method for inhibiting progression of fibrosis in a patient who has systemic sclerosis, the method comprising administering to the patient an anti-IL-31 receptor A antibody. The claims do not require that the anti-IL-31 receptor A antibody possess any particular conserved structure nor other disclosed distinguishing feature. Claims encompass a genus of anti-IL-31 receptor A antibodies without any structural features.
For each claim drawn to a genus, MPEP §2163 II.A.3(a) ii) (page 2100-189) states, “The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A), above), reduction to drawings (see i)(B), above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus (see i)(C), above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406”. In the instant case, the specification discloses a neutralizing antibody against human IL-31 receptor A, “Antibody A” (page 5, paragraph [0007]; page 10, paragraph [0022), and a neutralizing antibody against mouse IL-31RA (page 10, paragraph [0022]). However, such an instant disclosure is insufficient to support the broad genus of anti-IL-31 receptor A antibodies.
Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the genus of anti-IL-31 receptor A antibodies, and thus the instantly claimed method of using the same.
Claim Rejections[Symbol font/0xBE]35 USC § 112 (b)
6. The following is a quotation of the second paragraph of 35 U.S.C. 112:
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.
7. Claim 14 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 14 recites “a method of treating a patient identified as having systemic sclerosis, the method comprising administering to the patient an anti-IL-31 receptor A antibody”. The claim is indefinite because it does not point out the disease or condition to be treated.
Claim Rejections [Symbol font/0xBE]35 USC § 112 (d)
8. The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
9. Claims 7-10 and 16 are rejected under 35 U.S.C. 112 (d), as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Specifically, claims 7-10 and 16 recite properties or biological effects of an anti-IL-31 receptor A antibody. However, all these properties or biological effects are inherent to the anti-IL-31 receptor A antibody itself. Thus, claims 7-10 and 16 do not further limit the anti-IL-31 antibody recited in claim 5 or claim 14.
Claim Rejections under 35 USC § 103(a)
10. The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
11. Claims 5-19 are rejected under 35 U.S.C. 103(a) as being unpatentable over Yaseen et al. (Rheumatology, 59 (9): 2625–2636, September 2020) in view of US 11,723,976 B2 (Date of Patent: Aug. 15, 2023; priority date: Nov. 20, 2019).
Yaseen et al. teach that interleukin-31 promotes pathogenic mechanisms underlying skin and lung fibrosis in scleroderma (systemic sclerosis). Yaseen et al. teach that IL-31/IL-31RA is confirmed as a candidate pro-fibrotic pathway, which may contribute to skin and lung fibrosis in a subset of scleroderma patients see, e.g., Abstract).
Yaseen et al. do not teach a method for inhibiting progression of fibrosis in a patient or a method for inhibiting the progression of skin fibrosis or lung fibrosisin a patient who has systemic sclerosis comprising administering to the patient an anti-IL-31 receptor A antibody.
US 11,723,976 B2 teach a method of treating a subject affected with an IL-31-associated disorder, comprising administering to the subject a formulation comprising an anti-IL-31RA antibody, which is identical to the anti-IL-31 receptor A antibody recited in the instant claims of the present application.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to make and use the antibody taught by US 11,723,976 B2 to treat fibrosis, such as skin fibrosis or lung fibrosis, in a patient who has systemic sclerosis with a reasonable expectation of success. One would have been motivated to do because IL-31/IL-31RA is a candidate pro-fibrotic pathway and contributes to skin and lung fibrosis in scleroderma patients as taught by Yaseen et al., whereas an anti-IL-31RA antibody can be used to a subject affected with an IL-31-associated disorder as taught by US 11,723,976 B2.
Priority
12. Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy of PCT/JP2020?044406, filed on 11/30/2020 has been filed. However, an English translation has not been provided yet.
Conclusion
13. No claims are allowed.
Advisory Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ruixiang Li whose telephone number is (571) 272-0875. The examiner can normally be reached on Monday through Friday from 8:30 am to 5:00 pm. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Vanessa Ford, can be reached on (571) 272-0857. The fax number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/RUIXIANG LI/ Examiner, Art Unit 1674
August 11, 2026
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