DETAILED OFFICE ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The request filed on 19 November 2025 for a Continued Examination (RCE) under 37 CFR 1.114 based on parent Application No. 17/897,946 is acceptable, and an RCE has been established. An action on the RCE follows.
Applicant’s amendment filed on 19 November 2025 is acknowledged and entered. Following the amendment, the new claim 29 is added.
Currently, claims 1, 3, 10, 11, 13, 15-22 and 27-29 are pending, and claims 1, 3, 11, 13, 15-22 and 27-29 are under consideration. Claim 10 remains withdrawn from further consideration as being drawn to a non-elected invention/species.
Withdrawal of Objections and Rejections:
The prior art rejection of claim 22 under 35 U.S.C. 103(a) as being unpatentable over Clinical Trial NCT03921411 (v9, 8/24/2021), and Ghosh et al. (US 2019/0183904 6/20/2019) is withdrawn in view of new grounds of rejection, which are set forth below.
The prior art rejection of claims 1, 3, 11, 13, 15, 17-22, 27 and 28 under 35 U.S.C. 103(a) as being unpatentable over Clinical Trial NCT03921411 (v9, 8/24/2021); Ghosh et al. (US 2019/0183904 6/20/2019); Pivarcsi et al. (Curr Allergy Asthma Rep. 2005 Jul;5(4):284-90); and Zhang et al. (Arch Dermatol Res. 2006 Mar;297(9):425-9) is withdrawn in view of new grounds of rejection, which are set forth below.
The prior art rejection of claims 1, 3, 11, 13, 15, 17-22, 27 and 28 under 35 U.S.C. 103(a) as being unpatentable over Clinical Trial NCT03921411 (v9, 8/24/2021); Ghosh et al. (US 2019/0183904 6/20/2019); Pivarcsi et al. (Curr Allergy Asthma Rep. 2005 Jul;5(4):284-90); and Zhang et al. (Arch Dermatol Res. 2006 Mar;297(9):425-9) is withdrawn in view of new grounds of rejection, which are set forth below.
The prior art rejection of claims 1, 3, 11, 13, 15-22, 27 and 28 under 35 U.S.C. 103 as being unpatentable over Clinical Trial NCT03921411 (v9, 8/19/2021), Ghosh et al. (US 2019/0183904, 6/20/2019), Pivarcsi et al. (Curr Allergy Asthma Rep. 2005 Jul;5(4):284-90); and Zhang et al. (Arch Dermatol Res. 2006 Mar;297(9):425-9), and further in view of Kuramochi et al. (US 8,575,317, 11/5/2013), is withdrawn in view of new grounds of rejection, which are set forth below.
Formal Matters:
Claims
Claim 28 is objected to for the following informalities, appropriate correction is required:
Claim 28 recites “the nemolizumab”; the following is suggested: “nemolizumab” as nemolizumab is already a specific term.
Rejections under 35 U.S.C. §112:
The following is a quotation of 35 U.S.C. 112(b):
(B) CONCLUSION. - The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
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.
Claim 11 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 11 is indefinite for the recitation “wherein the subject is an adolescent, optionally between the ages of 12 and 17 years old” because it is unclear what the limitation is meant, and what the age range of “an adolescent” is, and specification does not define the term. For example, according to WHO, “[A]dolescence is the phase of life between childhood and adulthood, from ages 10 to 19.” According to this definition, claim 11 recites the broad age range of “an adolescent” (ages 10 to 19), and the claim also recites “optionally between the ages of 12 and 17 years old”, which is the narrower statement of the range/limitation. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the instant case, the claim is considered indefinite because there is a question or doubt as to whether the feature introduced by the narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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.
Written Description
Claims 1, 3, 11, 13, 15-17, 19-22 and 27 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, 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, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1, 3, 11, 13, 15-17, 19-22 and 27 are directed to a method of treating atopic dermatitis (AD) with an anti-IL-31RA antibody (claims 1 and 22, for example), or nemolizumab … or variant thereof (claim 17), which “an anti-IL-31RA antibody” reads on any or all anti-IL-31RA antibodies; and the “variant thereof” does not even require any meaningful functional property other than “anti-IL-31RA” (binding?) or treating AD. However, the specification merely discloses one anti-IL-31RA antibody, i.e., nemolizumab; and no other anti-IL-31RA antibody and no variant of nemolizumab (0) meeting the limitations of the claims are ever identified or particularly described in the specification.
The first paragraph of 35 U.S.C. § 112 "requires a 'written description of the invention' which is separate and distinct from the enablement requirement." “[A]pplicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed.” (See page 1117.) The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed.” Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563, 1111, 1116, 1117 (Fed. Cir. 1991).
To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. Sufficient description of a genus requires the disclosure of either (1) a representative number of species falling within the scope of the genus or (2) description of structural features common to the members of the genus so that one of skill in the art can "visualize or recognize" the members of the genus. In the instant case, only one anti-IL-31RA antibody (nemolizumab), is disclosed in the specification, i.e., only one species is disclosed for the claimed broad genus of “an anti-IL-31RA antibody”; and no variant of nemolizumab is disclosed in the specification, i.e., 0 species is disclosed for the claimed broad genus of “variant thereof” of nemolizumab. Given the fact that the structures of monoclonal antibodies differ each from each other, especially in the CDR regions, there is no way to predict the sequence structure of any other anti-IL-31RA antibody or a variant of nemolizumab based on that of nemolizumab and the “functional” limitation (treating AD). Thus, with the exception of nemolizumab comprising the CDRs of SEQ ID NO: 8-10 and 12-14; or VH and VL of SEQ ID NO: 7 and 11, respectively; or H and L chains of SEQ ID NO: 5 and 6, respectively (specification, pages 49-50, [0128] - [0133], for example), one of skill in the art cannot "visualize or recognize" the members of the claimed genus.
"A description of what a material does, rather than of what it is, usually does not suffice." Rochester, 358 F.3d at 923; Eli Lilly,119 at 1568. Instead, the "disclosure must allow one skilled in the art to visualize or recognize the identity of the subject matter purportedly described." Id. Accordingly, the specification does not provide adequate written description of the claimed broad genus of “anti-IL-31RA antibody”, or “variant thereof” of nemolizumab. Due to the limited species disclosed (one for “an anti-IL-31RA antibody”, and 0 for the “variant thereof” of nemolizumab) that meets the limitations of the claims (treating AD); the broad breadth of the claimed genus, and the lack of structural limitation and lack of predictability for the structures of the encompassed anti-IL-31RA antibody, and “variant thereof” of nemolizumab, one skilled in the art would not conclude that the applicant was in possession of the claimed genus.
Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. One cannot describe what one has not conceived. See Fiddes v. Baird, 30 USPQ2d 1481 at 1483.
Therefore, only the anti-IL-31RA antibody nemolizumab, but not the full breadth of the claims (“anti-IL-31RA antibody”, and “variant thereof” of nemolizumab) meets the written description provision of 35 U.S.C. §112, first paragraph. Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. §112 is severable from its enablement provision (see page 1115).
Prior Art Rejections
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 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 11, 13, 15, 17-22 and 27-29 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Clinical Trial NCT04365387 (v1, 4/28/2020).
Clinical Trial NCT04365387 discloses a study to assess immunization responses in adult and adolescent participants with moderate-to-severe atopic dermatitis treated with nemolizumab (title, for example), in which study, participants received a loading dose of 60 mg nemolizumab via 2 subcutaneous (SC) injections, and 30 mg nemolizumab SC every 4 weeks (Q4W) at weeks 4, 8, and 12 (7th page, under “Arms and Interventions”), wherein the participates were adult and adolescent subjects (≥ 12 to 54 years) with moderate-to-severe AD (6th page, under “Detailed Description”; and 12th page, under “Eligibility”). Note, nemolizumab is an anti-IL-31RA antibody. Therefore, the reference anticipates claims 1, 11, 13, 15, 17-22 and 27-29. With respect to the limitation “wherein treatment with the anti-IL-31RA antibody reduces expression of at least one of CCL20, CCL22, CCL27, and VEGF in a skin lesion” or alike recited in claims 1, 22 and 29, such represents treatment results or efficacy, which would be inherent properties of the prior art method since the active ingredient, method step and patient population of the claimed method are the same as that of the prior art reference; and treatment results or efficacy is out of anyone’s control.
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 of this title, 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3, 11, 13, 15, 17-22 and 27-29 are rejected under 35 U.S.C. 103 as being unpatentable over Clinical Trial NCT04365387 (v1, 4/28/2020), as applied to claims 1, 11, 13, 15, 17-22 and 27-29 above, and further in view of Ghosh et al. (US 2019/0183904 6/20/2019, provided by applicants).
The teachings of Clinical Trial NCT04365387 are reviewed above. Clinical Trial NCT04365387 does not teach that expression of at least one of CCL20, CCL22, CCL27, and VEGF is determined by the methods recited in claim 3.
Teachings of Ghosh were reviewed in the previous Office Action, and are paraphrased herein:
Ghosh teaches a method of diagnosing and treating a subject suffering from AD, which method comprises: (a) obtaining a skin biopsy from a subject suspected of suffering from AD; (b) determining a level of RNA expression in the skin biopsy of genes selected from the 89ADGES gene panel; (c) comparing the determined level of RNA expression of the selected genes to the level of RNA expression of the selected genes in a reference sample comprising RNA expression products from normal healthy skin cells; (d) diagnosing the subject as suffering from AD when specific genes are up-regulated compared to the reference sample and when specific genes are down-regulated compared to the reference sample; and (e) treating the subject with a therapy effective for the treatment of AD (abstract, for example); wherein the 89ADGES members up-regulated in AD include CCL18 and CCL22 (page 6, Table 3, for example), and wherein the level of RNA expression in the skin biopsy is detected by quantitative RT-PCR (page 16, Example 6, for example). Additionally, Ghosh teaches that the present inventors have designed a gene panel for definitive molecular diagnosis of AD and monitoring of treatment outcomes of AD patients (page 1, [0008]).
With respect to claim 3, it would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to treat AD in an adolescent patient with an anti-IL-31RA antibody such as nemolizumab using the regimen taught by NCT04365387, wherein the patient has elevated expression of CCL18 and/or CCL22 in the skin lesion, which expression is detected by RT-PCR, following the teachings of NCT04365387 and Ghosh. The person of ordinary skill in the art would have been motivated to do so for disease diagnosis and treatment, and reasonably would have expected success because NCT04365387 teaches that an anti-IL-31RA antibody such as nemolizumab can be used for treating AD; and Ghosh has demonstrated the up-regulated expression of CCL18 and CCL22 in skin lesion of AD patients by RT-PCR.
Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Claims 1, 3, 11, 13, 15-22 and 27-29 are rejected under 35 U.S.C. 103 as being unpatentable over Clinical Trial NCT04365387 (v1, 4/28/2020), and Ghosh et al. (US 2019/0183904 6/20/2019, provided by applicants), as applied to claims 1, 3, 11, 13, 15, 17-22 and 27-29 above, and further in view of Kuramochi et al. (US 8,575,317, 11/5/2013).
The teachings of Clinical Trial NCT04365387 and Ghosh are reviewed above. Neither reference teaches the specific CDRs of the anti-IL-31RA antibody as recited in the present claim 16.
Teachings of Kuramochi were reviewed in the previous Office Action, and are paraphrased herein:
Kuramochi teaches anti-NR10 antibodies having an effective neutralizing activity against NR10, which antibodies are useful as, for example, pharmaceuticals for treating inflammatory diseases (abstract, for example), wherein one of such antibodies comprises a VH region comprising the amino acid sequence of SEQ ID NO: 207; and a VL region comprising the amino acid sequence of SEQ ID NO: 220 (claim 1, part (2), for example). Kuramochi’s VH of SEQ ID NO: 207 comprises the present H-CDRs of SEQ ID NO: 8-10, respectively, with 100% sequence identity; and Kuramochi’s VL of SEQ ID NO: 220 comprises the present L-CDRs of SEQ ID NO: 12-14, respectively, with 100% sequence identity. Additionally, Kuramochi teaches that NR10 functions as an IL-31 receptor; and IL-31 has been reported that transgenic mice overexpressing IL-31 spontaneously develop pruritic dermatitis (column 1, lines 42-45); and that preferred examples of the inflammatory diseases include atopic dermatitis, chronic dermatitis, rheumatism, osteoarthritis, chronic asthma, and pruritus (column 40, lines 59-62; and claim 5, for example “atopic”).
With respect to claim 16, it would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to treat AD in an adolescent patient with an anti-IL-31RA antibody such as Kuramochi’s anti-NR10 antibody comprising the VH of SEQ ID NO:207 and the VL of SEQ ID NO: 220, wherein the patient has elevated expression of CCL18 and/or CCL22 in the skin lesion, which expression is detected by RT-PCR, following the teachings of NCT04365387, Ghosh, and Kuramochi. The person of ordinary skill in the art would have been motivated to do so for disease treatment, and reasonably would have expected success because Kuramochi teaches that the anti-NR10 antibodies having an effective neutralizing activity against NR10; and can be used for treating inflammatory diseases such as atopic dermatitis.
Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Conclusion:
No claim is allowed.
Advisory Information:
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/DONG JIANG/
Primary Examiner, Art Unit 1674
3/8/26