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 .
Amended claims 34-35, 39-41, 47, 49, 52-53(9/22/2026), previously pending claims 36-38, 42-46, 48, 50-51, and new claim 54, (9/22/2026), are under consideration by the Examiner.
Claims 1-33 have been canceled.
Information Disclosure Statement
3. The information disclosure statement (IDS) submitted on 9/22/2026 is in compliance with the provisions of 37 CFR 1.97 and has been considered by the examiner.
Applicant is reminded of their duty to disclose to the Office all information known to the person to be material to patentability as defined in 37 CFR 1.56. As stated therein, “[e]ach individual associated with the filing and prosecution of a patent application has a duty of candor and good faith in dealing with the Office, which includes a duty to disclose to the Office all information known to that individual to be material to patentability as defined in this section”.
4. Receipt of Applicant's arguments and amendments filed on 9/22/2026 is acknowledged.
5. The following previous rejections and objections are withdrawn in light of Applicants amendments filed on 9/22/2026:
(i) the rejection of claim 35 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement;
(ii) the rejection of claim 34-53 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement; and
(iii) the rejection of claims 34-53 under 35 U.S.C. 103 as being unpatentable over US Patent No. 10,174,121 (AbbVie Inc) as applied to claims 34-39, and 42-51, and further in view of Visvanathan et al (March 2019).
Claim Rejections - 35 U.S.C. § 112 second paragraph
6. The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
5a. Claim 51 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 51 is rejected on the basis that the claim contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984).
The Markush grouping of claim 51 recites, “the method of claim 34, wherein the method treats an autoimmune disease, a T cell mediated autoimmune disease, or an IL-1β mediated autoimmune disease” which is confusing because the alternatives defined by the Markush grouping “a T cell mediated autoimmune disease, or an IL-1β mediated autoimmune disease” are species of the genus “autoimmune disease”, which is an improper Markush group recitation. See MPEP § 2117. Applicant argues that the M.P.E.P. § 2173.05(h) (page 2100-495 bridging paragraph between columns 1 and 2) states: "For example, the Markush group, 'selected from the group consisting of amino, halogen, nitro, chloro and alkyl' should be acceptable even though 'halogen' is generic to 'chloro."' However, contrary to Applicants arguments, the instant claim should be amended to recite “the method of claim 34, wherein the method treats an autoimmune disease selected from a T cell mediated autoimmune disease, or an IL-1β mediated autoimmune disease” to obviate this rejection.
Claim rejections-35 U.S.C. 102
6. 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 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.
6a. Claims 34-39, 41-54 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by US Patent No. 10,174,121 (AbbVie Inc).
This rejection is maintained for reasons of record set forth at pages 13-14 of the previous action dated 5/1/2026.
US Patent No. 10,174,121 (AbbVie) discloses a method for treating an autoimmune disease, rheumatoid arthritis (column 8, lines 47-51) comprising subcutaneous, intravenous or parenteral administration to a human, a composition (See abstract; column 63, lines 10-24; column 60, lines 54-57) comprising (a) the TNF signaling inhibitor adalimumab (column 56, lines 39-46; column 57, lines 46-50; column 55, lines 47-49) and (b) a CD40 inhibitor which is a humanized CD40 antibody (abstract; column 58, lines 1-5). The method disclosed in the reference would inherently result in inhibition of the production of IL-1β, because the same active agents (TNF signaling inhibitor (adalimumab) and CD40 inhibitor (humanized CD40 antibody)) by the same mode of administration, are administered in both the instant claims and the prior art reference. The fact that Applicant may have discovered yet another beneficial effect from the method set forth in the prior art does not mean that they are entitled to receive a patent on that method. Therefore, although the reference is silent about inhibiting production of IL-1β, it does not appear that the claim language or limitations result in a manipulative difference in the method steps when compared to the prior art disclosure. See Bristol-Myers Squibb Company v. Ben Venue Laboratories 58 USPQ2d 1508 (CAFC 2001). “(i)t is a general rule that merely discovering and claiming a new benefit of an old process cannot render the process again patentable”. In re Woodruff, 16 USPQ2d 1934, 1936 (Fed. Cir. 1990). The mechanism of action does not have a bearing on the patentability of the invention if the invention was already known. Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. In re Wiseman, 201 USPQ 658 (CCPA 1979). Granting a patent on the discovery of an unknown but inherent function would remove from the public that which is in the public domain by virtue of its inclusion in, or obviousness from, the prior art. In re Baxter Travenol Labs, 21 USPQ2d 1281 (Fed. Cir. 1991). See M.P.E.P. 2145.
Therefore, the method disclosed in the reference anticipates claims 34-39, and 41-51.
Applicant argues that there is no single disclosure of the composition includes all of the limitations of Applicant's claims, as required for an anticipatory disclosure; the TNF antagonist must be picked from an enormously long list of "second agents" recited at col. 56, 1. 24 to col. 58, 1. 17, Benatuil provides no teaching or disclosure of a single composition as found in Applicant's claims, Benatuil never mentions inhibiting IL1beta, the rejection has not established that IL1beta inhibition necessarily flows from Benatuil, and the only way that IL1beta inhibition can be shown in Benatuil is if all of the compositions in Benatuil can be shown to inhibit IL1beta. However, contrary to Applicant’s arguments, independent claim 34 recites “….wherein the TNF signaling inhibitor comprises infliximab, adalimumab, certolizumab, certolizumab pegol, golimumab, etanercept, remsima, thalidomide, lenalidomide, pomalidomide, or pentoxifylline, and wherein the CD40 inhibitor comprises iscalimab, a humanized anti-CD40 ligand antibody, or a humanized anti-CD40 antibody”. The recitation of “or” indicates that a method in which any one of the TNF signaling inhibitors recited and any one of the CD40 inhibitors administered in the prior art, meets the limitations of the method of the instant claims. In the instant prior art, the TNF signaling inhibitor “adalimumab” and the CD40 inhibitor “humanized anti-CD40 antibody” is taught in the priort art.
Although the reference is silent about inhibiting production of IL-1β, it does not appear that the claim language or limitations result in a manipulative difference in the method steps when compared to the prior art disclosure. See Bristol-Myers Squibb Company v. Ben Venue Laboratories 58 USPQ2d 1508 (CAFC 2001). “(i)t is a general rule that merely discovering and claiming a new benefit of an old process cannot render the process again patentable”. In re Woodruff, 16 USPQ2d 1934, 1936 (Fed. Cir. 1990). The mechanism of action does not have a bearing on the patentability of the invention if the invention was already known. Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. In re Wiseman, 201 USPQ 658 (CCPA 1979). Granting a patent on the discovery of an unknown but inherent function would remove from the public that which is in the public domain by virtue of its inclusion in, or obviousness from, the prior art. In re Baxter Travenol Labs, 21 USPQ2d 1281 (Fed. Cir. 1991). See M.P.E.P. 2145.
Therefore, the method disclosed in the reference anticipates claims 34-39, and 41-54.
Claim rejections-35 U.S.C. 103
7. The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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.
7a. Claims 34-54 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent No. 10,174,121 (AbbVie Inc) as applied to claims 34-39, and 42-51 above, and further in view of Cordoba et al (2015).
The teachings of US Patent No. 10,174,121 (‘121) (AbbVie Inc) are set forth above in paragraph 6a. The reference is silent with respect to a method comprising administering a different CD40 inhibitor, iscalimab (CFZ533), with the TNF signaling inhibitor, adalimumab.
Cordoba et al teach administering an anti-CD40 monoclonal antibody, iscalimab (CFZ533), for treatment of renal allograft survival in clinical transplantation (See abstract; page 2827, Figure 1; page 2828, Figure 2).
Therefore, it would have been prima facie obvious to one having ordinary skill in the art to modify the method of the ‘121 reference such that it includes administering the TNF signaling inhibitor, adalimumab, in combination with a different CD40 antibody, iscalimab (CFZ533), to obtain the known functions and advantages of both adalimumab and iscalimab (CFZ533), and to increase the clinical efficacy of the claimed invention since the combination could be synergistic. One would have been motivated to administer iscalimab (CFZ533), because Cordoba teaches the advantage of administering iscalimab (CFZ533) to prolong allograft survival (See abstract) by administering the anti-CD40 antibody. To combine two compositions each of which is taught by the prior art to be useful for the same purpose in order to form a third composition that is to be used for very same purpose would have been obvious to one of ordinary skill in the art at the time the invention was made. The combination would have been obvious to the skilled artisan and the results achieved would have been expected (In re Kerkhoven, 205 USPQ 1069). Therefore, the combined teachings of US Patent No. 10,174,121 and Cordoba et al renders obvious claims 34-54, in the absence of evidence to the contrary.
Conclusion
No claim is allowed.
Claims 34-54 are rejected.
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.
Advisory Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PREMA MARIA MERTZ whose telephone number is (571)272-0876. The examiner can normally be reached on Monday to Thursday from 7:30am to 6:00pm.
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/PREMA M MERTZ/ Primary Examiner, Art Unit 1674
