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 preliminary amendment filed 18 December 2023 has been received and entered. Claims 1-43 have been canceled and new claims 44-56 have been added. Claims 44-56 are under consideration in the instant office action.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
At the time of the instant Office action, no IDS had been received. Applicant is reminded of their Duty to Disclose (see 37 CFR 1.56).
Drawings
The drawings are objected to because they 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. See example below:
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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 01 June 2023 do not meet this standard as text is blurry (see below),
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lines are not solid (see below),
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and many of the features in the drawings barely visible (see below- from Fig. 5A).
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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.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (see page 37 of the specification filed 12 January 2026, last paragraph). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 44-50 are rejected 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. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
Claims 44-50 were added by a preliminary amendment filed 18 December 2023, after the filing of the instant application (filed on 01 June 2023). Therefore, the added claims are not considered part of the original disclosure. Original claim 1 provided support for a “method of treating an inflammatory disease in a patient” comprising the administration of an IL-23 inhibitor and a TNF-
α
inhibitor. Original dependent claims added limitations related to clinical response, the nature of the inhibitors and the specific disease to be treated. The original disclosure however does not provide support for the recited method of the current claims 44-50.
Current claim 44 is directed to a method of treating inflammatory disease in a patient comprising administering an anti-IL-23p19 antibody (identified by CDR structure and heavy/light chain structures) and an anti-TNF-α antibody (identified by CDR structure and heavy/light chain structures) and wherein the anti-IL-23p19 antibody and anti-TNF-α antibody are in specific aqueous solutions. Claim 44 also includes the limitation:
“wherein the anti-TNF-α antibody and the anti-IL-23p19 antibody are administered in a ratio of from 1:2 to 2:1 (w/w) or from 15:1 to 400:1 (w/w)”.
This limitation is considered new matter.
The instant specification fails to disclose a method of treating an inflammatory disease in a patient with the specified ratio of antibodies. The instant specification does not recite “an inflammatory disease” anywhere in the entire 63 pages of the disclosure. The specification is particularly directed to “inflammatory bowel diseases”, including Crohn’s disease and ulcerative colitis. The specification provides support for a specific treatment for inflammatory bowel disease which administers the antibodies of the claims in the recited ratios but the specification at no point discloses treatment of any and all “inflammatory disease” by this particular regimen. Therefore, the claims are rejected for new matter.
Claim 56 is rejected 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. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Claim 56 is directed to a method of reducing inflammation of the colon in a patient with inflammatory bowel disease and wherein “after administration of the anti-IL-23p19 antibody and the anti-TNF-α antibody, histopathology of the colon is identical to that of normal tissue”. The instant claim is not enabled for a method which recites in the histopathology of the colon being identical to that of normal tissue.
Inflammatory bowel disease is a condition which presents with a number of histopathological characteristics and architectural abnormalities which include crypt branching and/or shortening, decreased crypt density and irregular mucosal surface as well as inflammatory features which include transmucosal increase of lamina propria mononuclear cells and the presence of epithelioid granulomas (Villanacci et al. Histological healing in inflammatory bowel disease: A still unfulfilled promise. World J. Gastroenterol..19(7): 968-978, 2013; see page 969, column 2, paragraph 3). The histological features of inflammatory bowel disease are variable in time however, about 75% of patients with longstanding disease in remission present with decreased crypt density (see Villanacci et al., page 969, column 2, paragraph 4).
The data presented in the instant specification do not support a method wherein after administration of the two antibodies “histopathology of the colon is identical to that of normal tissue”. Figure 5A-5C provides histopathology data and one of the treatment groups were found to be “identical” to that of normal tissue. The term “identical” means that there are no differences and the two tissues would be indistinguishable. One of ordinary skill in the art would not reasonably conclude that a subject with inflammatory bowel disease who had been treated for the condition with the claimed method would present with a colon that is histologically identical to normal tissue. The claimed end point of “identical” appears to be unrealistically out of reach considering the tissue damage and structural changes that occur in the course of inflammatory bowel disease. Furthermore, the data which is presented in the instant application does not support this end point as there is no evidence of histopathology which is identical to that of normal tissue. Therefore, the claim is not enabled.
Taking the results of the instant application into consideration, Applicant may want to claim something along the lines of that the colon returns to normal histologically, or something to that general effect.
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.
Claims 52-55 are 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 52 recites “wherein the inflammation is very minimal or normal”. The term “very minimal” in claim 52 is a relative term which renders the claim indefinite. The term “very minimal” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Applicant may consider a limitation of “wherein the inflammation is reduced or normal”.
Claim 53 recites “wherein gland loss is very minimal or normal”. The term “very minimal” in claim 53 is a relative term which renders the claim indefinite. The term “very minimal” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim 54 recites “wherein erosion is very minimal or normal”. The term “very minimal” in claim 54 is a relative term which renders the claim indefinite. The term “very minimal” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention
Claim 54 recites “wherein mucosal thickness and hyperplasia are independently very minimal or normal”. The term “very minimal” in claim 55 is a relative term which renders the claim indefinite. The term “very minimal” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
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 are group differently between the instant claims and 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.
Claims 51-56 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 5-7 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) the same anti-IL-23p19 and anti-TNFα antibodies in the same ratio as instant claim 51. Claim 6 of ‘393 recites the composition of the pharmaceutical formulations of the antibodies which is identical to that of instant claim 51. 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.
Claims 51-56 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 8-10, 12-14, 20-28, 32-34, 38-40 and 44-50 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 1-2, 8-10, 12, 26, 32, 38-39, 44-48) in the same pharmaceutical compositions (claim 40 and 48) and in the same ratios (claims 13-14, 27-28, 33-34 and 49-50). ‘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.
Claims 51-56 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 53, 55, 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 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.
Citation of Relevant Prior Art
WO 2013/087911-A1 (Ariaans et al.)
WO 2014/004436-A2 (Reichert et al.)
Conclusion
No claim is allowed.
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, 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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/Christine J Saoud/Primary Examiner, Art Unit 1645
Prosecution Insights