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 .
Status of Claims
Applicant’s amendment filed on 05/19/2025 is acknowledged. Following the amendment, claims 8, 10, and 13 are amended. Claims 7-13 are currently pending and under examination.
Claim Rejections - 35 USC § 112
Applicant’s arguments, see pg. 4, filed 05/19/2025, with respect to rejection of claim 13 under 35 U.S.C. 112(a) have been fully considered and are persuasive. The rejection of claim 13 under 35 U.S.C. 112(a) has been withdrawn.
In addition, applicant’s arguments, with respect to rejection of claims 8, 10, and 13 under 35 U.S.C. 112(b) have also been fully considered and are persuasive. The rejection of claims 8, 10, 13 under 35 U.S.C. 112(b) has been withdrawn.
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.
Claims 7-13 remain rejected under 35 U.S.C. 102(a)(1) as being anticipated by clinical trial NCT03200782 (first posted 06/27/2017).
Regarding claims 7-12, NCT03200782 (‘782) teaches a study to investigate whether hypoglycaemia observed after food intake in patients post bariatric surgery can be influenced via inhibition of inflammation with a human interlukin-1 receptor antagonist (Summary). Trial ‘782 specifies the use of anakinra as an active comparator with a dosage of 100mg, three hours before meal intake (Arms and Interventions). Trial ‘782 teaches bariatric operation types to include sleeve gastrectomy and roux-y-gastric bypass in patients with documented hypoglycemia and hypoglycaemic symptoms (Inclusion Criteria).
Regarding claim 13, instant application specification teaches that anakinra is a non-agonist antibody or antagonist that binds to IL-1 receptor type 1 (pg. 4, lines 11-15). Trial ‘782 discloses treating patients with anakinra following bariatric surgery in order to limit postprandial hypoglycemia (Brief Summary, Detailed Description).
Therefore, Clinical Trial NCT03200782 anticipates claims 7-13.
Applicant's arguments filed 05/19/2025 have been fully considered but they are not persuasive. Applicant makes the argument on pg. 4 of remarks that Trial ‘782 is “merely speculative” and that it does not teach all the limitations of the subject claims and therefore do not anticipate the pending claims. Examiner disagrees as Trial ‘782 discloses all the limitations presented in the instant application as discussed above.
Applicant’s disclosure of the mechanistic connection between upregulation of inflammatory markers and hypoglycemia in post bariatric surgery subjects does not preclude anticipation by Trial ‘782 of the current limitations in claims 7-13 of the present application. Anticipation is based on whether the intended use of the present claims was already taught and not on whether the prior art articulated the why (see MPEP 2131, MPEP 2121(III)). As noted in MPEP 2121(III), “proof of efficacy is not required for a prior art reference to be enabling for purposes of anticipation." Impax Labs. Inc. v. Aventis Pharm. Inc., 468 F.3d 1366, 1383, 81 USPQ2d 1001, 1013 (Fed. Cir. 2006) (citing Rasmusson v. SmithKline Beecham Corp., 413 F.3d 1318, 1326, 75 USPQ2d 1297, 1302 (Fed. Cir. 2005)).
Furthermore, a newly discovered mechanistic rationale for an old use does not make the use novel (see MPEP 2112 (I); Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Since the instant application limitations are focused on the intended use of a method incorporating an IL-1 antagonist to inhibit development of hypoglycemia in subjects following bariatric surgery, the prior art reference of Trial ‘782 teaches the intended use, the population group and meets the instant application claim limitations.
Conclusion
No claims are allowable.
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DENNIS GEORGE whose telephone number is (571)270-0340. The examiner can normally be reached M-F 8:30am - 5pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Daniel E Kolker can be reached at (571)272-3181. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DENNIS GEORGE/Examiner, Art Unit 1644
/DANIEL E KOLKER/Supervisory Patent Examiner, Art Unit 1644