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 .
Status of Claims
The amendments to the claims filed October 24, 2024 are acknowledged and entered. Claims 33-44 are pending.
Priority
This application is a 371 of PCT/EP2022/069362, filed July 11, 2022, which claims priority of EP21305971.0, filed July 12, 2021, and EP22315039.2, filed February 24, 2022.
Information Disclosure Statement
Acknowledgement is made of the Information Disclosure Statement filed on April 8, 2024. All references have been considered except where marked with a strikethrough.
Specification
The disclosure is objected to because it contains embedded hyperlinks and/or other form of browser-executable code (see paragraphs [0014], [0057]-[0061]). 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.
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any of the errors of which applicant may become aware of in the specification.
Election/Restriction
Applicant's election with traverse of Group I (claims 33-39) and the species of disease corresponding to dermatomyositis in the reply filed on June 24, 2026 is acknowledged. The traversal is on the ground(s) that the search of Groups I and III, for example, necessarily overlap as they are both directed to methods of treatment by administering compound 1, and thus no burden exists to search/ examine the claims of these groups together. This is not found persuasive because as noted in the restriction requirement the shared technical feature (compound 1) is known and therefore the claims lack unity of invention.
The requirement is still deemed proper and is therefore made FINAL.
Claims 40-44 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on June 24, 2026.
The guidelines in MPEP § 803.02 provide that upon examination if prior art is found for the elected species, the examination will be limited to the elected species.
The elected species was found in the prior art; however, the search was further expanded to an inflammatory disease and/or a disease associated with hypersecretion of IFNα and/or interferons, IL-12 and/or IL-23.
Claim Objections
Claim 33 objected to because of the following informalities:
The claim recites “an inflammatory disease, a disease associated with hypersecretion of IFNα and/or interferons, IL-12 and/or IL-23 in a human” and it is believed the claim should recite “an inflammatory disease, and/or a disease associated with hypersecretion of IFNα and/or interferons, IL-12 and/or IL-23 in a human”. Support for this amendment can be found at least at paragraph [0001] of the specification.
Appropriate correction is required.
Claim Rejections - 35 USC § 112b
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 33-39 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. The claims are indefinite for the reasons that follow:
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 33 recites the broad recitation “interferons”, and the claim also recites “INFα” which is the narrower statement of the range/limitation. “INFα” or interferon alfa is embraced by the larger scope of “interferons” (see also [0004] of the specification, interferon (including IFNα, IFNβ). The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claims 34-39 depend directly or indirectly from claim 33, do not cure the above mentioned deficiency, and are thus also indefinite.
Claim Rejections - 35 USC § 103
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 33-39 are rejected under 35 U.S.C. 103 as being unpatentable over Van Der Plas et al. (WO2019/076716 A1, published 2019)(hereinafter “Van Der Plas”).
Van Der Plas teaches generic compounds of Formula I, including compound 38 (Table III, page 108; pictured below for convenience), which are useful in a method for treating inflammatory disease or diseases associated with hypersecretion of interferons (INFα), IL-12 and/or IL-23 (Abstract, [0001]; Claim 1 and 15; Table III Illustrative Compounds of the Invention; [0014]). Compound 38 of Van Der Plas corresponds to compound 1 of the instant claims.
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Van Der Plas explicitly teaches a method of treating psoriatic-like epidermal hyperplasia in a subject, wherein the subject is a mouse, comprising administration of compound 1 of the claims wherein compound 1 prevented significantly IL-23 induced ear thickening (see Example 3, Murine model; [0422] mice are dosed with test-compound; [0428] illustrative compound 38). Van Der Plas teaches where the subject may be human ([0014]).
Regarding claim 34-36, Van Der Plas teaches compounds may be administered orally wherein oral dosing is once daily in an amount between 30 and 250 mg which includes 90 mg or 150 mg ([0213]-[0214]).
Regarding claim 37, Van Der Plas teaches administration to a subject in a fed state ([0418] food and water are provided ad libitum).
Regarding claim 38, Van Der Plas teaches wherein the disease associated with hypersecretion of IFNα is dermatomyositis ([0076]).
Regarding claim 39, Van Der Plas teaches wherein the compound may be administered as a composition ([0168]).
The difference between the prior art and the instant claims is that the instant claims recite a method of treating disease in a human subject. However, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the instant application to modify Van Der Plas into a method of treating an inflammatory disease or diseases associated with hypersecretion of interferons, such as dermatomyositis, as is presently claimed because Van Der Plas had already disclosed that the claimed compound (compound 38 which corresponds to instant compound 1) could be administered to a human ([0014] subject may be human).
One would have been motivated simply as a matter of treating disease in a human.
One would have had a reasonable expectation of success because compound 1 of the instant claims had already been shown to be effective in an animal model of disease (Example 3; compound 38 which corresponds to compound 1 of the claims prevented significantly IL-23 induced ear thickening) and Van Der Plas taught that the subject of treatment could be human.
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 33-39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 16-19 of U.S. Patent No. 11,564,923 B2 in view of Sairenji et al. (Prim Care 2017 44(4) Abstract))(hereinafter “Sairenji”).
Patent claim 1 is drawn to a compound of Formula (I).
Patent claim 16 depends from claim 1 and recites wherein the compound is 4-Methyl-5-[3-methyl-7-( 6-morpholin-4-yl-pyridazin-3-ylamino )-3H-imidazo [ 4,5-b ]pyridin-5-yloxy ]-pyridine-2-carbonitrile which corresponds to compound 1 of the instant claims.
Patent claim 17 depends from claim 16 and recites a pharmaceutical composition.
Patent claim 18 depends from claim 16 and recites a method for treatment of inflammatory diseases, autoinflammatory diseases, autoimmune diseases, and/or diseases associated with hypersecretion of IFNα, IL12 and/ or IL23, comprising administering an effective amount of the compound, or pharmaceutically acceptable salt thereof, according to claim 16, to a subject in need thereof.
Patent claim 19 recites a method of treatment comprising administering a pharmaceutical composition to a subject in need thereof.
The patent claims are silent regarding wherein the subject is human and wherein the disease is one selected from those recited in instant claim 38; however, Sairenji teaches ulcerative colitis is an inflammatory condition that affects people of all ages (Abstract).
The difference between the patent claims and the instant claims is that the instant claims recite a method of treating disease in a human subject and the instant claims require a specific dose, dosing regimen, and route of administration of compound 1. The patent claims do not recite the doses, regimen and administration route required by the invention; however, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant claims to modify the patent claims into a method of treating inflammatory disease in a human subject because at the time inflammatory diseases, such as ulcerative colitis, were known to affect people. Furthermore, treatment of an inflammatory condition would obviously have required administration of a drug dose, and how much drug to administer to a patient, route of administration and timing of administration would have obviously required optimization, as is routine in the art, in order to treat the patient. Treating any of the hundreds of diseases embraced by the claims thus would have likely included oral administration in a dose required by the instant claims.
One would have been motivated as a matter of practicing the patented invention in the treatment of inflammatory disease in a human subject. One would have optimized the drug dose, route and timing of administration as a matter of treating an inflammatory condition.
One would have had a reasonable expectation of success because the patented invention was useful for treating inflammatory disease and humans were known to be afflicted by inflammatory diseases. Moreover, persons of ordinary skill in the art routinely adjust drug administration dose, timing and route to optimize treatment of a medical condition.
Claim 33-39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of U.S. Patent No. 12,472,181 B2 in view of Sairenji et al. (Prim Care 2017 44(4) Abstract))(hereinafter “Sairenji”).
Patent claim 1 is drawn to a compound according to Formula 38. Formula 38 corresponds to compound 1 of the instant claims.
Patent claim 2 depends from claim 1 and recites a pharmaceutical composition.
The patent claims do not recite a method of treatment; however, the patent specification teaches compounds and compositions of the invention are useful in the treatment of inflammatory diseases (col 1). In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See also Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008);Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003).
The patent claims are silent regarding wherein the subject is human and wherein the disease is one selected from those recited in instant claim 38; however, Sairenji teaches ulcerative colitis is an inflammatory condition that affects people of all ages (Abstract).
The difference between the patent claims and the instant claims is that the instant claims recite a method of treating disease in a human subject and the instant claims require a specific dose, dosing regimen, and route of administration of compound 1. The patent claims do not recite the doses, regimen and administration route required by the invention; however, the claimed invention would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the instant application for the reasons provided above regarding the rejection of the claims over U.S. Patent No. 11,564,923 B2 which are incorporated herein by reference.
Claims 33-39 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 and 4-17 of copending Application No. 19/364,059 in view of Sairenji et al. (Prim Care 2017 44(4) Abstract))(hereinafter “Sairenji”).
This is a provisional nonstatutory double patenting.
Reference claim 1 is drawn to a compound of Formula I
Reference claim 7 recites wherein the compound is of formula IIIc
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Reference claim 8 recites wherein L1 is a single bond.
Reference claim 10 recites wherein R1 is morpholinyl
Reference claim 12 recites a pharmaceutical composition comprising the compound of claim 1.
Reference claims 15 recites a compound for use in the treatment of inflammatory diseases.
Reference claim 17 recites a pharmaceutical composition for use in the treatment of inflammatory diseases.
The reference claims do not explicitly recite compound 1 of the instant claims; however, a person skilled in the art can plainly see that the compound of the instant claims is formula IIIc of the reference application wherein L1 is a single bond and R1 is morpholinyl. The reference claims clearly include compound 1 of the instant claims.
The reference claims are silent regarding treatment in a human subject and wherein the disease is one selected from those recited in instant claim 38; however, Sairenji teaches ulcerative colitis is an inflammatory condition that affects people of all ages.
The difference between the reference claims and the instant claims is that the instant claims recite a method of treating disease in a human subject and the instant claims require a specific dose, dosing regimen, and route of administration of compound 1. The reference claims do not recite the doses, regimen and administration route of administration required by the invention; however, the claimed invention would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the instant application for the reasons provided above regarding the rejection of the claims over U.S. Patent No. 11,564,923 B2 which are incorporated herein by reference.
Conclusion
No claim is allowed.
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July 22, 2026
/KEVIN S MARTIN/Examiner, Art Unit 1624
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