DETAILED ACTION
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 .
Priority
This application, filed on 04/09/2024 is a continuation of U.S. Patent Application No. 17/264,882, filed on 02/1/2021, which is a national phase of International Application No. PCT/EP2019/071904, filed on 08/15/2019, which claims priority to European Application No. 18189195.3 filed on 08/15/2018.
DETAILED ACTION
Applicant amendment and arguments filed on 09/15/2025 have been received and been carefully considered. Claims 1 and 9-10 were amended, and claims 2-5, 7-8, and 11-18 were cancelled. Claims 1, 6, and 9-10 are pending.
Withdraw Claim Objections
Objection to claim 4 for including an additional period in line 4, is withdrawn in view of applicant amendment filed on 09/15/2025 that cancelled claim 4.
Withdraw Claim Rejections - 35 USC § 103
Rejection to claims 1-9 and 11-18 under 35 U.S.C. 103 as being unpatentable over R. Pero (WO 1999/63987 A1, 12/16/1999), is withdrawn in view of applicant amendment filed on 09/15/2025 that cancelled claims 11-18 (Note: claim 1-9 maintained rejected as being anticipated by R. Pero, see the 102 Rejection below).
Rejection to claims 1, 2, 7, 11, 12, and 15-16 under 35 U.S.C. 103 as being unpatentable over A. Bjork et al. (USPN 6,518,312 B2, 02/11/2003, “Bjork”), is withdrawn in view of applicant amendment filed on 09/15/2025 that amended claim 1 and cancelled claims 2, 7, 11-12 and 15-16.
Rejection of claims 3-6, 8-9, 13-14, and 17-18 under 35 U.S.C. 103 as being unpatentable over A. Bjork et al. (USPN 6,518,312 B2, 02/11/2003) in view of R. Pero (WO 1999/63987 A1, 12/16/1999), is withdrawn in view of applicant amendment filed on 09/15/2025 that amended claims 1 and 9, and cancelled claims 3-5, 8, 13-14, and 17-18.
Withdraw Claim Rejections – Double Patenting
Rejection of claim 1-5, 11-14, and 17-18 on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11,717,500 B2, Rejection of claims 6-9, 15-16 on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11,717,500 B2 as applied above to claims 1-5, 11-14, and 17-18, in view of R. Pero (WO 1999/63987 A1, 12/16/1999), and Rejection of claim 10 on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11,717,500 B2 in view of R. Pero (WO 1999/63987 A1, 12/16/1999), further in view of D. Antonov, et al. (Drug-induced lupus erythematosus, Clinics in Dermatology, Volume 22, Issue 2, 2004, Pages 157-166, ISSN 0738-081X, is withdrawn in view of applicant amendment filed on 09/15/2025 that amended claims 1 and 9, and cancelled claims 2-5, 7-8 and 11-18.
Terminal Disclaimer
The terminal disclaimer filed on 09/22/2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patent No. 11,896,564 B2 and 11,717,500 B2, has been reviewed and is accepted. The terminal disclaimer has been recorded.
Rejection of claims 1-5, and 7-18 on the ground of nonstatutory double patenting as being unpatentable over claims 1-12, 13 and 22 of U.S. Patent No. 11,896,564 B2, and rejection of claim 6 on the ground of nonstatutory double patenting as being unpatentable over claims 1-12, 13 and 22 of U.S. Patent No. 11,896,564 B2 in view of R. Pero (WO 1999/63987 A1, 12/16/1999), is withdrawn in view of filed and approved Terminal Disclaimer.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 6, and 9 remain rejected under 35 U.S.C. 102(a)(1) as being anticipated by R. Pero (WO 1999/63987 A1, 12/16/1999, “Pero” cited in the PTO-892 dated 07/02/2025).
Pero discloses a method of treating inflammatory disorders comprising administering, to a human or animal suffering from an inflammatory disorder, an amount of a composition consisting of N-acetyl-3-chloroprocainamide, its acid addition salts, and mixtures thereof, said amount being effective to inhibit TNF-α production, thereby to inhibit an inflammatory response in human or animal, [Pero, pg. 4, col. 4, ln. 32-40]:
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Pero’s above compound is the same compound of claim 1.
Pero discloses that the inflammatory disorders include ulcerative colitis. [Pero, pg. 3, col. 2, ln. 56- 59].
Instant specification recites that inflammatory Bowel Disease mainly refers to Crohn’s disease and ulcerative colitis:
IBD, mainly comprised of Crohn's disease (CD) and ulcerative colitis (UC), is a chronic, frequently progressive condition of the gastrointestinal tract that requires lifelong treatment. [Specification page 2, ln. 23-25].
Therefore, Pero meets each and every limitation of claim 1.
With regard to claim 6, Pero discloses that the N-substituted benzamides inhibit TNF-α in the absence of pro-apoptotic stimuli, while anti-inflammatory agent such as metoclopramide inhibit TNF-α production in the presence of or as a consequence of pro-apoptotic stimuli. [Pero, pg. 4, col. 3, ln. 46-55].
With respect to claim 9 Pero discloses that the inflammatory disorders include but not limited to rheumatoid arthritis, ulcerative colitis, psoriasis, etc. [Pero, pg. 3, col. 2, ln. 56- 59].
Response to Arguments
Applicant argues:
Pero does not explicitly disclose a method of treatment of IBD in a mammal, by administering the compound 4-acetamido-3-chloro-N-[2-(diethylamino)ethyl]benzamide. Consequently, the subject-matter of independent claim 1, as amended, is novel over Pero. Accordingly, Applicant respectfully requests reconsideration and withdrawal of the rejections.
Examiner response:
Applicant’s arguments have been fully considered but they are not persuasive. Pero discloses that the inflammatory disorders include ulcerative colitis. [Pero, pg. 3, col. 2, ln. 56- 59]. The instant specification recites that inflammatory Bowel Disease mainly refers to Crohn’s disease and ulcerative colitis: “IBD, mainly comprised of Crohn's disease (CD) and ulcerative colitis (UC), is a chronic, frequently progressive condition of the gastrointestinal tract that requires lifelong treatment.” [Instant specification page 2, ln. 23-25]. According to the instant specification, Pero discloses a species of the claimed disease, and therefore, Pero meets the limitation of claim 1. Note that independent claim 9 defines IBD as ulcerative colitis.
Note: Argument to claims 1-9 and 11-18 under 103 over Pero are moot because the rejection is withdrawn in view of the Applicant amendments, see withdrawn claim rejection above. Also, arguments with respect to Bjork are moot because the rejection over Bjork is withdrawn, see withdraw claim rejection above.
§ 103 Rejection over Pero in view of Antonov
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over R. Pero (WO 1999/63987 A1, 12/16/1999, “Pero”, as applied above to claims 16, and 9) in view of D. Antonov, et al. (Drug-induced lupus erythematosus, Clinics in Dermatology, Volume 22, Issue 2, 2004, Pages 157-166, ISSN 0738-081X, doi.org/10.1016/j.clindermatol.2003.12.023, Antonov” cited in the PTO-892).
As discussed above and incorporated herein, Pero teaches compound, N-acetyl-3-chloroprocainamide its acid addition salts; and uses thereof, [Pero, pg. 4, col. 3, 58-61]. Pero teaches that N-acetyl-3-chloroprocainamide, its acid addition salts, and mixtures thereof, are effective to inhibit TNF-α production, thereby to inhibit an inflammatory response in human or animal, [Pero, pg. 4, col. 4, ln. 32-40]. Pero teaches a method of using N-acetyl-3-chloroprocainamide for treating inflammatory disorder, wherein the inflammatory disorders include but not limited to rheumatoid arthritis, ulcerative colitis, psoriasis, etc. [Pero, pg. 3, col. 2, ln. 56- 59].
While Pero teaches treatment of inflammatory disorder ulcerative colitis with N-acetyl-3-chloroprocainamide, Pero does not teach the inflammatory disorder include Crohn’s disease.
Antonov teaches that therapies directed against TNF-α are effective treatment for rheumatoid arthritis, psoriasis and Crohn’s disease. [Antonov, pg. 163, col. 1, 4th para.]. Antonov teaches that procainamide is one of TNF-α blockers used to treat Crohn’s disease:
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It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the instantly claimed invention to use N-acetyl-3-chloroprocainamide taught by Pero for treating Crohn’s disease in view of the teachings of Antonov. One of ordinary skill in the art would have been motivated to do so with reasonable expectation of success because Pero teaches N-acetyl-3-chloroprocainamide inhibits TNF-α and use for treating pathological inflammation related to Crohn’s disease such as ulcerative colitis, and Antonov teaches that TNF-α inhibitors are effective for treating Crohn’s disease. As such one of ordinary skill in the art would have been motivated to substitute Antonov’s TNF-α inhibitor, procainamide with Pero’s TNF-α inhibitor, N-acetyl-3-chloroprocainamide to treat Crohn’s disease.
Response to Arguments
Applicant’s arguments filed on September 15, 2025 did not include any traversal specific to the rejection of Claim 10 over the combination Pero and Antonov. To the extent that Applicant’s arguments against the rejection based solely on Pero were intended to be applied to the instant rejection as well, the Examiner’s rebuttal of Applicant’s arguments are incorporated herein by reference and this rejection is maintained.
Conclusion
Claims 1, 6, and 9-10 are rejected. No claims are allowed.
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.
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/M.M.A./Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622
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