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
Response to Amendment
The Information Disclosure Statement (IDS) filed 25 June 2026 has been entered. Applicant’s amendment of the claims filed 25 June 2026 has been entered. Applicant’s remarks filed 25 June 2026 are acknowledged.
Claims 1-16, 19-20, 23, 25-30, 33 and 37-48 are cancelled. Claims 49-78 have been added. Claims 17-18, 21-22, 24, 31-32, 34-36 and 49-78 are pending and under examination.
Claim Objections/Rejections Withdrawn
The objection to claims 39 and 45 for using an acronym (e.g., “JAK”) without defining what it represents at the first use of the acronym is withdrawn in view that claims 39 and 45 are cancelled.
The objections to claim 35, 40 and 46 for various informalities are withdrawn in response to Applicant’s amendment of claim 35 and cancellation of claims 40 and 46.
The rejection of claims 17-18, 21-22, 24, 31-32, 34-36, 42 and 48 under 35 U.S.C. 101, because the claimed invention is not directed to patent eligible subject matter, is withdrawn in response to Applicant’s amendment of independent claims 17 and 21 to include administration of a particular treatment.
The rejection of claims 17-18, 21-22, 24, 31-32, 34-36, 42 and 48 under 35 U.S.C. 112(a), as failing to comply with the enablement requirement, is withdrawn in response to Applicant’s amendment of the claims.
Claim Rejections Maintained / New Grounds of Rejections
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 17-18, 21-22, 24, 31-32, 34-36, 50, 52-53, 55, 57, 60, 62, 65, 67-68, 70, 72, 75 and 77 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 claims contain 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Independent claims 17 and 21 have been amended to recite “wherein the therapeutic agent is selected from the group consisting of: a) a steroid drug; b) an aminosalicylate; c) an antimetabolite; d) a calcineurin inhibitor; e) a tumor necrosis factor (TNF) inhibitor; f) a Janus kinase (JAK) inhibitor; and g) an integrin receptor antagonist.” However, the specification as originally filed does not provide adequate written description and support for the invention as now claimed.
In the previous Office Action, it was indicated that the specification has described “a JAK inhibitor” (at p. 7). Upon further review, there is no adequate written description and support in the application for a JAK inhibitor. The specification discloses a species “Tofacitinib” which belongs to the genus of “JAK inhibitor”, however, the single species is not sufficient to represent the genus. Such is evidenced by Taylor et al. (Rheumatology (Oxford), 2024, Vol. 63(2):298–308). Taylor et al. teaches that small molecule JAK inhibitors (JAKis) have key differences that could potentially translate into unique clinical profiles; each JAKi has a unique chemical structure, resulting in a distinctive mode of binding within the catalytic cleft of the target JAK, and giving rise to distinct pharmacological characteristics; in addition, the available agents have differing selectivity for JAK isoforms, as well as off-target effects against non-JAKs (see Abstract). There is no adequate written description and support for the genus of JAK inhibitors for use in the treatment methods as presently claimed.
As for “an aminosalicylate”, “an antimetabolite”, “a calcineurin inhibitor”, “a tumor necrosis factor (TNF) inhibitor”, and “an integrin receptor antagonist”, recited in amened claims 17 and 21, the specification also fails to adequately describe these genera of molecules. Applicant argues that the specification lists the therapeutic agents including 5-aminosalicylic acid (5ASA), azathioprine, mercaptopurine, Infliximab, Adalimumab, Golimumab, Tofacitinib, Vedolizumab, Tacrolimus, and Ciclosporin, which together correspond to representative species for the chemical genera of an aminosalicylate, an antimetabolite, a calcineurin inhibitor, a TNF inhibitor, a JAK inhibitor, and an integrin receptor antagonist (referring to Exhibits 1-8). However, there is no sufficient description of a representative number of species for the claimed genus. For example, an integrin receptor antagonist can be a protein or peptide, an antibody, a nucleic acid, or a small molecule that have diverse structures and underlying mechanisms, and the disclosure of Vedolizumab is not sufficient to satisfy an adequate written description for the genus of “integrin receptor antagonist”. The specification does not provide sufficient teachings regarding the structural characteristics of the molecules within a genus that are therapeutically effective in treating ulcerative colitis or primary sclerosing cholangitis. In the absence of sufficient recitation of distinguishing identifying characteristics, the skilled artisan cannot envision the detailed structures of the encompassed molecules that can be used in the treatment methods as presently claimed.
Further, the instant claims recite limitations which were not clearly disclosed in the specification as filed, such limitations introduce new concepts and do not comply with the written description requirement set forth under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph. The specification as originally filed does not provide support for the invention as now claimed: “wherein the therapeutic agent is selected from the group consisting of: a) a steroid drug; b) an aminosalicylate; c) an antimetabolite; d) a calcineurin inhibitor; e) a tumor necrosis factor (TNF) inhibitor; f) a Janus kinase (JAK) inhibitor; and g) an integrin receptor antagonist.” (claims 17 and 21). Applicant points to the therapeutic agents listed above (i.e., 5-aminosalicylic acid (5ASA), azathioprine, mercaptopurine, Infliximab, Adalimumab, Golimumab, Tofacitinib, Vedolizumab, Tacrolimus, and Ciclosporin) and Exhibits 1-9 for support that these therapeutic agents constitute representative species of the claimed chemical genera. However, the instant specification as-filed does not have sufficient written support for the “limitations” indicated above. For example,
the specification describes 5-aminosalicyluic acid (5ASA), but there is no support for “aminosalicylate” (genus);
the specification describes azathioprine and mercaptopurine, but there is no support for “antimetabolite” or “purine analog” (genus);
the specification describes Tacrolimus, and Ciclosporin, but there is no support for “calcineurin inhibitor” (genus);
the specification describes anti-TNF agent (e.g., Infliximab, Adalimumab, Golimumab), but there is no support for “TNF inhibitor” (genus);
the specification describes Tofacitinib, but there is no support for “Janus kinase (JAK) inhibitor” (genus); and
the specification describes Vedolizumab, but there is no support for “integrin receptor antagonist” (genus).
The specification as originally filed fails to provide adequate written description and support for the listed therapeutic agents recited in the amended claims, and therefore the claims do not satisfy the written description requirement.
Allowable Subject Matter
Claims 49, 51, 54, 56, 58-59, 61, 63-64, 66, 69, 71, 73-74, 76 and 78 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
CLAIMS 49, 51, 54, 56, 58-59, 61, 63-64, 66, 69, 71, 73-74, 76 AND 78 ARE OBJECTED.
CLAIMS 17-18, 21-22, 24, 31-32, 34-36, 50, 52-53, 55, 57, 60, 62, 65, 67-68, 70, 72, 75 AND 77 ARE REJECTED.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Xiaozhen Xie, whose telephone number is 571-272-5569. The examiner can normally be reached on M-F, 8:30-5.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Vanessa L. Ford, can be reached on 571-272-0857. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/XIAOZHEN XIE/Primary Examiner, Art Unit 1674
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