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 .
Response to Amendment
Applicant’s response filed 10 July 2026 has been received and entered. Claims 44, 51-56 have been amended and claims 57-60 have been newly added. Claims 44-60 are currently pending and under consideration in the instant Office action.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Any objection or rejection of record which is not expressly repeated in this action has been overcome by Applicant's response and withdrawn.
Applicant's arguments filed 10 July 2026 have been fully considered but are not found to be persuasive.
NOTE: In Applicant’s response, paragraph numbers are referenced when pointing to support for amendments which have been made. However, the instant specification does not contain paragraph numbers which makes it difficult to determine the exact location Applicant is referencing for support of the amendments. Applicant may be intending to reference the paragraph numbering of the PGPub, however, this document is not application being examined and all references should be made in relation to the documents in the instant application and not a PGPub.
Drawings
The drawings were received on 10 July 2026. These drawings are not acceptable.
The drawings are objected to because they still do not comply with 37 CFR 1.84(a)(1) which requires that black and white drawings use India ink, or its equivalent that secures solid black lines for the reasons of record in the previous Office action (mailed 13 April 2026).
The drawings are also not compliant with 37 CFR 1.84(l) which requires that all drawings be made by a process which will give them satisfactory reproduction characteristics. Every line, number, and letter must be durable, clean, black, sufficiently dense and dark, and uniformly thick and well-defined. The drawings which were submitted 10 July 2026 do not meet this standard as text is still blurry, lines are still not solid and many of the features in the drawings are barely visible. While the text in some of the drawings is now darker, many of the lines are still not solid and clean and appear fuzzy (see screenshot below as an example).
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Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 51-56 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-42 of U.S. Patent No. 11,780,911. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are directed to treatment of the same patient population with the same compounds in the same pharmaceutical compositions with the same ratios/dosages.
While the combination of limitations is grouped differently between the instant claims and the claims of ‘911, the instant claims would be obvious over the claims of ‘911 as all the elements of the instant claims are provided for in ‘911. Claim 1 of ‘911 is directed to treating an inflammatory bowel disease in a patient, claim 12 is directed to treating ulcerative colitis, claim 22 is directed to reducing inflammation in the colon of a patient with inflammatory bowel disease, claim 34 is directed to treating inflammatory bowel disease and reducing weight in a patient and claim 40 is directed to a method of treating moderately to severely active ulcerative colitis in a patient. All of the claims of ‘911 administer an anti-IL-23p19 antibody and an anti-TNF-α antibody with the exact same structure as the antibodies of the instant claims. Claim 42 of ‘911 recites the same pharmaceutical compositions for the two antibodies as the instant claim 51. Claims 1, 12-14, 29-30 and 34 of ‘911 recite the same ratio of antibodies as recited in claim 1. Claims 23-27 of ‘911 recite the same therapeutic outcomes as the instant claims 52-56. Therefore, the instant claims are obvious over the claims of ‘911, absent evidence to the contrary.
Response to Arguments
Applicant asserts that a terminal disclaimer has been filed. The terminal disclaimer which was filed 10 July 2026 has been disapproved.
This application was filed on or after September 16, 2012. The person who signed the terminal disclaimer is not the applicant, the patentee or an attorney or agent of record. See 37 CFR 1.321(a) and (b).
Applicant may file a power of attorney that gives power to the attorney and/or agent of record who is signing the TD, along with another copy of the TD form. Or alternatively, a TD form that is signed by the applicant may be filed. No additional fee is required with a resubmission.
Claims 44-61 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 12,258,393. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘393 anticipate the instant claims.
‘393 is directed to a method comprising administering to patients with ulcerative colitis (an inflammatory bowel disease) with the same anti-IL-23p19 and anti-TNFα antibodies in the same ratio as instant claims 44, 51 and 61. Claim 6 of ‘393 recites the composition of the pharmaceutical formulations of the antibodies which encompasses those of instant claims 44, 51 and 61. Claims 2-5 of ‘393 recite dosing regimens which are also recited in the instant claims (see claims 45 and 47-50)Claims 1 and 7 of ‘393 recite particular outcomes of the method related to clinical response which are indications that the patients have been effectively treated. While ‘393 does not recite outcomes in the same way as the instant claims (52-56), the method of ‘393 administers the same therapeutic agents in the same ratio and therefore, would necessarily achieve the same outcomes. Therefore, the instant claims are anticipated or made obvious by the claims of ‘393 and therefore, not patentably distinct.
Response to Arguments
Applicant argues that the rejection should be withdrawn at least because based on a 20-year term there would be no unjustified extension of the term of the right to exclude granted by a second patent.
Applicant’s argument has been fully considered but is not found persuasive. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. Even if there would be no extension of patent term, the grant of a patent to the instant application would result in possible harassment by multiple assignees if the two patents were not commonly owned. Therefore, the rejection is maintained for the reasons of record.
Claims 44-61 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8-10, 12-13, 20-27, 32-33, 38-40 and 44-49 of copending Application No. 17/748,629 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because ‘629 and the instant application are directed to patentably indistinct methods.
‘629 is directed to treating an inflammatory bowel disease (claim 1), reducing inflammation of the colon in a patient with IBD (claim 20), treating IBD (claim 32) and treating ulcerative colitis (claims 39 and 44), all of which are variations of reducing inflammation of the colon in a patient with inflammatory bowel disease (instant claim 51). ‘629 administers the same anti-IL-23p19 and anti-TNFα antibodies (claims 1, 8-10, 12, 26, 32, 38-39, 44-48) in the same pharmaceutical compositions (claim 40 and 48) and in the same ratios (claims 13, 27, 33 and 49). ‘629 also recites the same therapeutic endpoint of instant claims 52-56 (see claims 21-25). While the limitations which are recited are in different combinations due to claim dependency, it would have been obvious to include any one or all of the limitations in the claimed method of reducing inflammation of the colon in a patient with inflammatory bowel disease as currently claimed and therefore, the claimed methods are not patentably distinct.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant asserts that the effective filing date of the instant application is before the filing date of ‘629 and therefore, this rejection should be withdrawn. Applicant’s argument has been fully considered but is not found persuasive. As this is not the only remaining rejection in the instant application, the rejection is maintained.
Claims 44-61 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 53-56, 58, 60-64 of copending Application No. 19/045,035 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because ‘035 and the instant application are directed to patentably indistinct methods.
‘035 is directed to treating an inflammatory bowel disease (claim 53) and reducing inflammation of the colon in a patient with IBD (claim 61), both of which are variations of reducing inflammation of the colon in a patient with inflammatory bowel disease (instant claim 51). ‘035 administers the same anti-IL-23p19 and anti-TNFα antibodies (claim 58) in the same pharmaceutical compositions (claim 60) and in the same ratios (claim 64). ‘035 also recites the same therapeutic endpoint of instant claims 52-56 (see claim 62). While the limitations which are recited are in different combinations due to claim dependency, it would have been obvious to include any one or all of the limitations in the claimed method of treating an inflammatory bowel disease or reducing inflammation of the colon in a patient with inflammatory bowel disease as currently claimed and therefore, the claimed methods are not patentably distinct.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant asserts that the effective filing date of the instant application is before the filing date of ‘035 and therefore, this rejection should be withdrawn. Applicant’s argument has been fully considered but is not found persuasive. As this is not the only remaining rejection in the instant application, the rejection is maintained.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 Christine J Saoud whose telephone number is (571)272-0891. The examiner can normally be reached M-F, 8am-4pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Julie Z Wu can be reached at 571-272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Christine J Saoud/Primary Examiner, Art Unit 1645
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