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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 07/03/2025 has been entered.
Claim Rejections - 35 USC § 103
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, 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.
Claims 1 and 3-13 are rejected under 35 U.S.C. 103 as being unpatentable over Daly et al. US 20200246488 A1, in view of Brogan et al (Brogan).
Daly teaches a method for modulating intestinal epithelial cell integrity, migration, proliferation, differentiation, maintenance and/or function in which the expression of Cp1orf106 or its protein product are modulated such that the stability of the protein is altered. In certain example embodiments, increasing the stability or preventing a decrease in the stability of Cp1orf106 protein increases the overall integrity of the intestinal epithelium, thereby resulting in a decreased incidence of inflammatory disease. See Abstract and paragraph 0006. In some embodiments, the modulation of intestinal epithelial cell integrity, migration, proliferation, differentiation, maintenance and/or function modulates inflammation of the gut. In some embodiments, the method of modulating includes administering an agent that modulates protein stability. In some instances, the agent that modulates protein stability modulates stability of the C1orf106 protein or a variant thereof. The C1orf106 variant protein, can be, for example *333F. In some instances, the agent modulates one or more of C1orf106 or its orthologs. See paragraph 0007. Inflammation can be inflammatory bowel disease, colitis, Crohn's disease, or food allergies. In an embodiment, the infection or inflammation is caused by a bacterial or parasitic infection. See paragraph 0011. Treatment of the disease may be performed by administering to the subject a modifying agent such that the expression of the gene or production of its protein product, or variants, homologs or orthologs thereof, is modified. Modification may be an increase or a decrease and may completely or partially ameliorate the symptoms of disease in the subject. See paragraph 0051.
Daly does not teach agent that up-regulate the expression of e-cadherin.
Brogan studied small molecule probes that restores e-cadherin expression at low micromolar concentrations. Fig.1 of Brogan teaches compounds that restores e-cadherin expression and compound 1 therein reads on ECU of instant claim 5. Table 3 shows EC50 of compound 1 (reads on instant claim 5). Brogan further studied a variety of functionalized phenyl heterocyclic units and reports that compound 11r (Table 1, page 4262) possess the most potent EC50 values (table 3). Table 4 shows the pharmacokinetic data of compound 11r. Brogan teaches that 11r, which reads on the instant claimed ML327 of claim 4, possess excellent in vitro pharmacokinetic profile with a long half-life following an IV dose and superior activity in restoring e-cadherin expression (last paragraph on p 4264). Accordingly, the small molecules of Brogan meet instant claims 4-6.
Thus, it would have been obvious for one of an ordinary skill in the art before the effective filing date of the instant invention to employ the small molecule probes (compounds 1 and 11r) of Brogan, as effective agents, in a pharmaceutical composition and administer the said composition to provide an effective treatment of conditions by upregulation or restoration of E-cadherin expression, such as inflammatory conditions, including inflammatory bowel disease and ulcerative colitis. One of an ordinary skill in the art would have been motivated to do so because Daly teaches the desirability for using compounds that can modulate intestinal epithelial cell integrity, migration, proliferation, differentiation, maintenance and/or function modulates inflammation of the gut. Further, this is because Brogan teaches that ML327 is known in the art to promote e-cadherin expression.
Response to Arguments
Applicant’s arguments filed 07/03/2025 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUSAN T TRAN whose telephone number is (571)272-0606. The examiner can normally be reached Monday-Friday, 8:30 am-5:30 pm.
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/SUSAN T TRAN/Primary Examiner, Art Unit 1615