The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 4, 30, are pending in this application.
Claims 1-3, 5-29, 31-36, are deleted.
Claim Rejections - 35 USC § 102
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.
Claim 4, is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zambrowicz et al., Clin Pharm and Therapeutics (2012), 92(2): 158-169.
Zambrowicz et al., teaches composition of LX4211, is SGLT1 inhibitor. See the entire document, particularly, the abstracts, introduction, tables 1-2, 4, and the discussion.
When LX4211 inhibits SGLT1 per the prior art, it must do so whether or not the subjects suffer from CF as in claim 4. Such is inherent property of LX4211. Therefore, the sub-populations in claim 4, are inherent in the prior art.
“An inherent structure, composition or function is not necessarily known . . . or obvious.” Schering Corp. v. Geneva Pharm. Inc., 67 USPQ2d 1664, 1667 (Fed. Cir. 2003). “Insufficient prior understanding of inherent properties of known composition does not defeat finding of [inherency]; insufficient scientific understanding does not defeat showing of inherency; [invention] is no more than showing that [prior art] did not recognize function inherently present”. Atlas Powder Co. v IRECO Inc., 51 USPQ2d 1943 (Fed Cir, 1999). A new use, new function or new property which is inherent in prior art composition is not patentable. In re Best, 195 USPQ 430 (CCPA, 1977).
Response
Applicant's arguments filed 11/19/25 have been fully considered but they are not persuasive. Applicant contends Zambrowicz et al., does not teach the sub-population of claim 4. Hence, the prior art cannot anticipate the claim. This is not persuasive for reasons set forth above. See particularly, the cited decisional laws.
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.
Claim 30, is rejected under 35 U.S.C. 103 as being unpatentable over Minamino et al., US20190192482 A1, in view of Zambrowicz et al., Clin Pharm and Therapeutics (2012), 92(2): 158-169.
Minamino et al., teaches composition of SGLT1 inhibitors, e.g. LX4211 [0005]: [4], [9], [0046], [0056] for treating cystic fibrosis, hyperglycemia, dyslipidemia, etc. [0037]. See also the entire document. The prior art teaches LX4211, cystic fibrosis, hyperglycemia, dyslipidemia as examples. However, Zambrowicz et al., teaches as set forth above under anticipatory rejection.
Having known as set forth above, a POSA would have known and be motivated to select LX4211 and CF from the invention by Minamino at the time the invention was made with reasonable expectation of success. Applicant did as taught by the prior arts.
Response
Applicant's arguments filed 11/19/25 have been fully considered but they are not persuasive. Applicant contends Minamino in view of Zambrowicz does not teach the sub-population of claim 4, and that Minamino does not teach inhibition of SGLTI, does not teach sotagliflozin or treatment of CF. This is not correct. Minamino et al., teaches composition of SGLT1 inhibitors, e.g. sotagliflozin (LX4211) for treating CF. See particularly [9].
This is a RCE of applicant's earlier Application No. 17/639,831. All claims are identical to, patentably indistinct from, or have unity of invention with the invention claimed in the earlier application (that is, restriction (including lack of unity) would not be proper) and could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the earlier application. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action in this case. See MPEP § 706.07(b). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Telephone Inquiry
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Taofiq A. Solola, whose telephone number is (571) 272-0709.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Andy Kosar, can be reached on (571) 272-0913. The fax phone number for this Group is (571) 273-8300.
Any inquiry of a general nature or relating to the status of this application or proceeding should be directed to the Group receptionist whose telephone number is (571) 272-1600.
/TAOFIQ A SOLOLA/ Primary Examiner, Art Unit 1625 December 31, 2025