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.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 04/09/2024, complies with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609. Accordingly, it has been placed in the application file and the information therein has been considered as to the merits, except where noted.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/15/2026 has been entered.
Status of Claims
The Amendments and Applicant’s Arguments submitted on 04/15/2026 have been received and
have been carefully considered.
Claim 1 was amended, and claims 2-5, 7-8, and 11-18 were cancelled. Claims 1, 6, and 9-10 are pending.
Withdraw Claim Rejections - 35 USC § 102
Rejection to claims under 35 U.S.C. 102(a)(1) as being anticipated by R. Pero (WO 1999/63987 A1, 12/16/1999), is withdrawn in view of Applicant’s amendments filed on 04/15/2026.
Withdraw Claim Rejections - 35 USC § 103
Rejection to claim 10 under 35 U.S.C. 103 as being unpatentable over R. Pero (WO 1999/63987 A1, 12/16/1999) 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(Drug-induced lupus erythematosus, Clinics in Dermatology, Volume 22, Issue 2, 2004, Pages 157-166, ISSN 0738-081X), is withdrawn because independent claim 1 is now rejected over Pero, Mayo Clinic and Nielsen in view of Applicant’s amendments filed on 04/15/2026.
New Rejection
Claim Rejections - 35 USC § 103
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 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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 6, and 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over R. Pero (WO 1999/63987 A1, 12/16/1999, “Pero” cited in the IDS dated 04/09/2024) in view of O. Nielsen et al. The New England Journal of Medicine 2013, 369, 8, pp. 754-762, “Nielsen” cited in the PTO-892) and Mayo Clinic (Ulcerative colitis. (2017). Mayo Clinic. Retrieved from Internet Archive, website: https://web.archive.org/web/20171009050920/http://www.mayoclinic.org/diseases-conditions/ulcerative-colitis/symptoms-causes/syc-20353326).
Pero teaches a method of treating inflammatory disorders comprising administering, to a human or animal suffering from an inflammatory disorder, an effective amount 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 teaches that the inflammatory disorders include ulcerative colitis. [Pero, pg. 3, col. 2, ln. 56- 59].
Pero does not teach “reducing at least one of diarrhea, blood in feces, and body weight loss in a mammal suffering from the treatment of a disease resulting from pathologic inflammation”.
However, Mayo Clinic teaches that ulcerative colitis is an inflammatory bowel disease (IBD) that causes long-lasting inflammation and ulcers(sores) in your digestive tract. [page 1, 1st para.]. Mayo Clinic teaches that ulcerative colitis symptoms can include Diarrhea, often with blood and weight loss [page 1 ending-page 2].
Nielsen teaches the use of TNF inhibitor for treating inflammatory bowel disease. [Title]. Nielsen teaches that inflammatory bowel disease is term for ulcerative colitis and Crohn’s disease. [page 754, 2nd para.]. Nielsen teaches the pivotal role of TNF in the inflammation in inflammatory bowel disease. [page 755, col. 1, 3rd para.]. Nielsen teaches that numbers of TNF inhibitors were used to treat ulcerative colitis and Crohn’s disease [page 755, col. 1-col. 2, Figure 1]. Nielsen teaches that patients treated with TNF inhibitors show complete remission. [page 758, col. 2, last para.]. Nielsen teaches that TNF inhibitor provide better control of the symptoms of inflammatory bowel disease compared to other treatments. [page 760, col. 1, 1st para.].
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of instantly claimed invention to use Pero’s TNF inhibitor, N-acetyl-3-chloroprocainamide for treating inflammatory bowel diseases, ulcerative colitis and Crohn’s disease and have the symptoms of ulcerative colitis and Crohn’s disease i.e., diarrhea, blood in feces and weight loss reduced. One of ordinary skill in the art would have been motivated to do so with reasonable expectation of success because Pero teaches the effectiveness of N-acetyl-3-chloroprocainamide as anti-inflammatory agent, Pero teaches the use of N-acetyl-3-chloroprocainamide for treating ulcerative colitis, and Nielson teaches the effectiveness of TNF for treating ulcerative colitis and Crohn’s disease and teaches that evidence of efficacy of TNF inhibitors in treating ulcerative colitis and Crohn’s disease have been reported. [page 755-757]. Thus, treatment of inflammatory bowel disease by administering N-acetyl-3-chloroprocainamide would reduce inflammatory bowel disease, diarrhea, blood in feces and weight loss because Mayo Clinic teaches that diarrhea, blood in feces and weight loss are the symptoms of inflammatory bowel disease, and treatment of the disease would include treatment od its symptoms. Moreover, Nielsen teaches that TNF inhibitors provide better control of the symptoms of inflammatory bowel disease compared to other treatments, and patients treated with TNF inhibitors show complete remission, thus, Pero’s TNF inhibitor, N-acetyl-3-chloroprocainamide would treat inflammatory bowel disease by reducing the disease symptoms, diarrhea, blood in feces and weight loss. Therefore, the combination of Pero, Mayo Clinic and Nielsen meet each and every limitation of claims 1, 9 and 10.
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].
Response to Arguments
Applicant argues:
Applicant amends claim 1 to a method for treating the symptoms of inflammatory bowel disease, rather than a method for treating the disease itself. Pero does not disclose or suggest administering 4- acetamido-3-chloro-N-[2-(diethylamino)ethyl]benzamide for reducing at least one of diarrhoea, blood in feces, and body weight loss" in a mammal suffering from an inflammatory bowel disease. The reference is silent with respect to the amended claimed therapeutic endpoints of (i) reducing diarrhoea, (ii) reducing blood in feces, or (iii) reducing body weight loss. In Example 6, the therapeutic effect of 4- acetamido-3-chloro-N-[2-(diethylamino)ethyl]-benzamide ("Cpd A") in an in vivo model of IBD was compared to that of sulfasalazine ("SASP"), which is well-known for use in the treatment of IBD. The results are shown in Tables 3 and 4 (pages 36-37) and the data presented in these tables demonstrate the surprisingly high reduction of disease activity index obtained by administration of 4-acetamido-3-chloro-N-[2- (diethylamino)ethyl]benzamide, even when compared to that of administration of SASP. Pero provides no disclosure, express or inherent, of any study or data showing an effect on these specific clinical manifestations.
Examiner response:
Applicant’s arguments have been fully considered but they are not persuasive because the 102 rejection over Pero is withdrawn, and amended claim 1 is now rejected over Pero, Mayo Clinic and Nielsen, see the above 103 Rejection. It appears that Applicant is attempting to show unexpected results. As provided in MPEP 716 (b), the evidence relied upon should establish "that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance." Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992). "[A]ppellants have the burden of explaining the data in any declaration they proffer as evidence of non-obviousness." Ex parte Ishizaka, 24 USPQ2d 1621, 1624 (Bd. Pat. App. & Inter. 1992). However, Nielsen teaches the effectiveness of TNF inhibitors for treating inflammatory bowel disease (see whole document). Nielsen teaches that patients treated with TNF inhibitors show complete remission. [page 758, col. 2, last para.]. Nielsen teaches that TNF inhibitor provide better control of the symptoms of inflammatory bowel disease compared to other treatments. [page 760, col. 1, 1st para.]. Thus, the asserted surprisingly high reduction of disease activity index appears to be insufficient and expected for THF inhibitors in view of Nielsen, and it was not surprising that the claimed compound also show reduction in the symptoms.
Conclusion
Claims 1, 6 and 9-10 are rejected. No claim is allowed.
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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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