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 .
Status of the Claims
Claims 1-13 were originally filed 8 July 2024 and the preliminary amendment filed the same day has been entered. Claims 14-39 are currently pending and under consideration.
Priority
Applicant states that this application is a continuation or divisional application of the prior-filed application. A continuation or divisional application cannot include new matter. Applicant is required to delete the benefit claim or change the relationship (continuation or divisional application) to continuation-in-part because this application contains the following matter not disclosed in the prior-filed application:
The instant application claims priority to application 17/986374 (referred to herein as ‘374 application) which was abandoned and U.S. provisional application 63/279,418 (referred to herein as ‘418 application).
It is noted the ‘374 nor the ‘418 application recites or contemplates the following clinical endpoints:
change in baseline in the CDAI score of “at least 180” at week 48 (see instant claim 14(i)),
change from baseline in CRP concentration of “at least -1” (see instant claim 14(ii)),
change from baseline in fecal calprotectin concentration of “at least -229” (see instant claim 14(iii)),
“at least 55.4% of patients in clinical remission at week 48 (see instant claim 27(i)),
“at least 51.5%” of patients in PRO-2 remission at week 48 (see instant claim 27(ii)), and
similar claimed percentages instant claim 27(iii-viii)).
The ‘418 provisional application discloses these singular values as results from a particular clinical trial. For example, the ‘418 application discloses at 48 weeks a 108.5 mean change in CDAI score (see ‘418 specification pg. 142 table 13) but does not disclose patients with a range of changes (i.e., at least 180) in CDAI score. These same particular results from a particular set of patients in a particular clinical trial are disclosed in the ‘374 application (see ‘374 pg. 143, table 13). Thus, neither the ‘418 nor ‘374 application recite or contemplate the genus of subjects or group of subjects with the instantly claimed ranges. Therefore, the priority date for the instant claims 14-39 is that of the instant application 30 July 2024.
Claim Rejections - 35 USC § 112(b)
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 14, 16-20, 25, 26 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 14 is drawn to wherein the patient is a responder to the antibody at week 48 after initial treatment, wherein the patient is identifies as meeting one or more clinical endpoints. The scope of “responder” is unclear. For example, is the patient considered a responder if they meet one or more the three clinical endpoints or alternatively is a patient considered a responder based on alternative criteria (e.g., decreasing IL-23 activity).
Claim 14 is drawn to “wherein the patient is a responder to the antibody at week 48 after initial treatment (“Week 48”)”. The scope of the parenthetical is unclear. For example, is “Week 48” an abbreviation for a responding patient at week 48 or alternatively is week 48 an abbreviation for a particular point in treatment independent of patient status.
Claims 16-19 and 29-32 recites the limitation "the intravenous dose" in line 1 and “the subcutaneous dose” in lines 1-2. There is insufficient antecedent basis for these limitations in the claim.
Claims 20 and 33 recites the limitation "the pharmaceutical composition" in line 3 and “the diluent” in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claims 25 and 38 is drawn to “wherein the patient is considered a biologic therapy failure or intolerance for Crohn’s disease (Bio-Failure)”. The scope of the parenthetical is unclear. For example, is Bio-Failure an abbreviation of biologic therapy failure, alternatively, a biologic therapy failure or intolerance for Crohn’s disease, or alternatively, Crohn’s disease.
Claims 25, 26, 38, and 39 is also drawn to “or intolerance for Crohn’s disease”. The clause is generally unclear. For example is the clause meant to be written “or intolerant for Crohn’s disease”. It is unclear where a patient is considered intolerant vs tolerant.
Claims 26 and 39 is drawn to “wherein the patient is considered a conventional therapy failure or intolerance for Crohn’s disease (Con-Failure)”. The scope of the parenthetical is unclear. For example, is Con’-Failure an abbreviation of conventional therapy failure, alternatively, a conventional therapy failure or intolerance for Crohn’s disease, or alternatively, Crohn’s disease.
Claim 27 is drawn to a method of treating Crohn’s disease in a group of patients comprising an administrating an IL23 antibody. It is unclear who the IL23 antibody is administered to. For example, is the antibody administered to every patient in the group or alternatively a subset of patients. Likewise claim 14 recites an administration step without identifying a subject/patient to administer the antibody to.
Claim 27 is also drawn to “wherein one or more of the following clinical endpoints are met at week 48 after initial treatment (“Week 48”)”. The scope of the parenthetical is unclear. For example, is Week 48 an alternative name, limitation (i.e., one or more clinical endpoints at week 48), or example.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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.
Claims 14-39 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Pub. No. 2019/0269757 (referred to as Adedokun; see IDS dated 01/18/2025 pg. 16 of 28, #25 (middle)) published 5 September 2019.
Adedokun claims the treatment of Crohn’s disease using the identical IL-23 antibody (see sequence comparison below), the specific treatment protocol, including frequency (e.g., every four weeks for 8 weeks and every 8 weeks after) and all doses (e.g., 100, 200, 600, and 1200mg) of IL-23, the method of administration (e.g., intravenous and subcutaneous), and the composition (see Adedokun claims 1-7, and 13) as recited in the instant application (see instant claims 14-20, 23, 24, 27-33, 36, and 37). Furthermore, Adedokun claims the identical combination therapy with IL-23 and the identical list of additional drugs recited in instant claims 21, 22, 34, and 35 (see Adedokun claims 11 and 12). Regarding instant claim 2, pursuant under MPEP 2131.02(I), a species will anticipate a claim to a genus. "A generic claim cannot be allowed to an applicant if the prior art discloses a species falling within the claimed genus." The species in that case will anticipate the genus. In re Slayter, 276 F.2d 408, 411, 125 USPQ 345, 347 (CCPA 1960); In re Gosteli, 872 F.2d 1008, 10 USPQ2d 1614 (Fed. Cir. 1989). As such, Adedokun claims identifying patients meeting at least one clinical endpoint out of 11 while the instant application claims meeting one or more of 3 (see instant claim 14) or 8 (see instant claim 27) clinical endpoints. All three of the clinical endpoints of the instant application (e.g., instant claim 14: i., ii., and iii. and instant claim 27: i.-v. and viii.) are identical to those claimed by Adedokun (see Adedokun claim 8: ii., iv., vi. xi., ix., and v.). It is noted the claimed clinical endpoints of Adedokun are measured at 12 and 48 weeks while the instant claims are drawn to the same clinical endpoints at 48 weeks. Absent evidence to the contrary, the clinical endpoints set forth in both instant claims 14, 27 and Adedokun are inherent to the treatment of Crohn’s Disease and therefore administering the identical IL-23 antibody with the same treatment protocol will have the same clinical endpoints whether measured at 12 weeks or 48 weeks. Adedokun claim 8 vii. and viii. are drawn to clinical remission or durable clinical remission at week 48 (i.e., the patient is a responder at week 48 (see instant claim 14 lines 15-16). It is noted, Adedokun does not recite the heavy or light chain amino acid sequences of the IL-23 antibody. However, the antibody of the instant claims 24 and 37, comprising SEQ ID NO: 10 and 9 as the light and heavy chains, is guselkumab (see specification, pg. 156 line 24 – pg. 159 line 20). The prior art reference by Adedokun teaches administration of guselkumab with the now-claimed protocol (see for example Adedokun, pg. 24 para [0257] – pg. 25 para [0263], pg. 26 para [0282 – 0286], pg. 27 para [0299 – 0302]). As the product administered in the prior art is guselkumab, it necessarily has the sequences as set forth in present SEQ ID NO: 9 and 10. Claims 27-39 are drawn to the treatment of a group of patients. Adedokun discloses administering the claimed antibody in clinical trials (i.e., a group of patients) (see Adedokun pg. 25 para [0263]). Claims 25, 26, 38, and 39 are drawn to particular patient populations (i.e., Con-Failure or Bio-Failure). Adedokun discloses a minimum of 25-50% are Con-failures and all patients are Bio-Failures (see Adedokun pg. 25, 2nd col. para [0273-0275]). Regarding the particular values recited in claim 27 for particular clinical endpoints, these are latent properties of the disclosed treatment protocol; therefore, anticipation of the treatment protocol anticipates the efficacy of the treatment.
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 (i.e., changing from AIA to pre-AIA ) 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 14-39 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over US Pub. No. 2019/0269757 (referred to as Adedokun) published 5 September 2019.
Adedokun claims the treatment of Crohn’s disease using the identical IL-23 antibody (see sequence comparison below), the specific treatment protocol, including frequency (e.g., every four weeks for 8 weeks and every 8 weeks after) and all doses (e.g., 100, 200, 600, and 1200mg) of IL-23, the method of administration (e.g., intravenous and subcutaneous), and the composition (see Adedokun claims 1-7, and 13) as recited in the instant application (see instant claims 14-20, 23, 24, 27-33, 36, and 37). Furthermore, Adedokun claims the identical combination therapy with IL-23 and the identical list of additional drugs recited in instant claims 21, 22, 34, and 35 (see Adedokun claims 11 and 12). Adedokun claims identifying patients meeting at least one clinical endpoint out of 11 while the instant application claims meeting one or more of 3 (see instant claim 14) or 8 (see instant claim 27) clinical endpoints. All three of the clinical endpoints of the instant application (e.g., instant claim 14: i., ii., and iii. and instant claim 27: i.-v. and viii.) are identical to those claimed by Adedokun (see Adedokun claim 8: ii., iv., vi. xi., ix., and v.). It is noted the claimed clinical endpoints of Adedokun are measured at 12 and 48 weeks while the instant claims are drawn to the same clinical endpoints at 48 weeks. Absent evidence to the contrary, the clinical endpoints set forth in both instant claims 14, 27 and Adedokun are inherent to the treatment of Crohn’s Disease and therefore administering the identical IL-23 antibody with the same treatment protocol will have the same clinical endpoints whether measured at 12 weeks or 48 weeks. Adedokun claim 8 vii. and viii. are drawn to clinical remission or durable clinical remission at week 48 (i.e., the patient is a responder at week 48 (see instant claim 14 lines 15-16). It is noted, Adedokun does not recite the heavy or light chain amino acid sequences of the IL-23 antibody. However, the antibody of the instant claims 24 and 37, comprising SEQ ID NO: 10 and 9 as the light and heavy chains, is guselkumab (see specification, pg. 156 line 24 – pg. 159 line 20). The prior art reference by Adedokun teaches administration of guselkumab with the now-claimed protocol (see for example Adedokun, pg. 24 para [0257] – pg. 25 para [0263], pg. 26 para [0282 – 0286], pg. 27 para [0299 – 0302]). As the product administered in the prior art is guselkumab, it necessarily has the sequences as set forth in present SEQ ID NO: 9 and 10. Claims 27-39 are drawn to the treatment of a group of patients. Adedokun discloses administering the claimed antibody in clinical trials (i.e., a group of patients) (see Adedokun pg. 25 para [0263]). Claims 25, 26, 38, and 39 are drawn to particular patient populations (i.e., Con-Failure or Bio-Failure). Adedokun discloses a minimum of 25-50% are Con-failures and all patients are Bio-Failures (see Adedokun pg. 25, 2nd col. para [0273-0275]). Regarding the particular values recited in claim 27 for particular clinical endpoints, these are latent properties of the disclosed treatment protocol; therefore, anticipation of the treatment protocol anticipates the efficacy of the treatment.
In so far as Adedokun recites clinical endpoints assessed at week 12 the ordinary artisan would find it obvious to use the same clinical endpoint at week 48 for consistency.
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 14-24 and 27-37 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 12,138,295 B2 (referred to herein as ‘295 patent). Although the claims at issue are not identical, they are not patentably distinct from each other.
The ‘295 patent claims a method of treating Crohn’s disease by administering an identical IL-23 antibody (see ‘295 claims 1, 12-15) in identical doses (see ‘295 claims 1-7, 14, and 15) via identical routes (see ‘295 claims 1-7, 14, and 15) with identical clinical endpoints (see ‘295 claims 8; i.e., claim 8(vii, viii, ix, x, and xii)) in an identical composition (see ‘295 claim 9), and identical combination therapy (see ‘295 claims 10 and 11; see instant claims 14-24 and 27-37). While the instant claims are drawn to either particular values of the clinical endpoints these are latent properties of the treatment and therefore are also anticipated by the ‘295 patent. Alternatively, the ordinary artisan would find it obvious to treat a group of patients with Crohn’s disease in view of the ‘295 patent claiming treating an individual with the same disease.
Regarding claims 25, 26, 38, and 38 drawn to particular patient populations. In performing the NSDP analysis, the first question to be asked is whether any examined claim is either anticipated by, or obvious over, a claim in the copending application. MPEP 804 (II)(B), second paragraph. While normally one cannot look into the specification of that copending application, it is in fact appropriate to learn which particular embodiments the claims cover. 804(II)(B)(1). The ’295 patent discloses specifically treating patients who are both Bio-Failures and Con-Failures (see ‘295 pg. 25, 2nd col. para [0273-0275]). Thus, when read in light of its corresponding specification, claim 1 (i.e., treating a patient) anticipates instant claims 25, 26, 38, and 39.
Claims 14, 15, 21-27, and 34-39 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 and 7-16 of copending Application No. 17/974,956 (referred to as ’956 application).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The ‘956 application claims a method for treating Crohn’s disease comprising administering an identical IL-23 antibody (e.g., guselkumab) (see ‘956 claims 1 and 14), frequency of doses (e.g., 1 in 4 weeks for 8 weeks, every 8 weeks after week 8) (see ‘956 claims 1-4), clinical endpoints (see ‘956 claims 8 and 9), combination therapy (see ‘956 claims 11-12), and patient populations (see ‘956 claims 15 and 16) (see instant claims 14, 15, 21-27, and 34-39). While the instant claims are drawn to either particular values of the clinical endpoints these are latent properties of the treatment and therefore are also anticipated by the ‘956 application. The ordinary artisan would find it obvious to treat a group of patients with Crohn’s disease in view of the ‘956 application claiming treating an individual with the same disease.
Claims 14-39 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 and 7-16 of copending Application No. 17/974,956 (referred to as ’956 application) and in view of Adedokun.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The claims of the ‘956 application are set forth above and the teachings of Adedokun are set forth above.
The ordinary artisan would find it obvious to substitution the particular doses claimed by the ‘956 application with the particular doses disclosed in Adedokun given Adedokun discloses the treatment is effective at these doses. It is noted Adedokun also provides further support for treating a group of patients with the particular ‘295 claimed protocol as well as particular clinical endpoints.
Claims 14-39 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-7 and 9-18 of copending Application No. 17/308302 (referred to as ’302 application).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The ‘302 application claim a method of treating Crohn’s disease by administering an identical IL-23 antibody (e.g., guselkumab) (see ‘302 claims 1, 13, 14, 17 and 18) frequency of doses (e.g., 1 in 4 weeks for 8 weeks, every 8 weeks after week 8; see ‘302 claims 1, 3-7, 17 and 18), concentration of doses (e.g., 1200mg, 600mg, 200mg and 100mg; see ‘302 claims 3-7 and 18), method of administration (e.g., intravenous, subcutaneous; see ‘302 claims 3-7, 17, and 18), clinical endpoints (see ‘302 claims 1, 9, 17, and 18), composition (see ‘302 claim 10), combination therapy (see “302 claims 11 and 12), and patient population (see ‘302 claims 15 and 16). While the instant claims are drawn to either particular values of the clinical endpoints these are latent properties of the treatment and therefore are also anticipated by the ‘956 application. The ordinary artisan would find it obvious to treat a group of patients with Crohn’s disease in view of the ‘956 application claiming treating an individual with the same disease.
Claims 14-39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 22, and 28 of U.S. patent 11,780,911 B2 (referred to as ’911 patent) and in view of Adedokun.
The ‘911 patent claims treating an inflammatory bowel disease (see ‘911 claim 1), in particular Crohn’s disease (see ‘911 claim 7), by administering an IL-23 inhibitory comprising identical sequences (see ‘911 claim 4-6), in combination with a TNF-α inhibitor (see ‘911 claim 1), using markers for CRP and/or fecal calprotectin in patient reported outcome3 and symptom measures (see ‘911 claim 2) (see instant claims 14, 20-24, 27, 33-37.
The teachings of Adedokun are set forth above.
Therefore the ordinary artisan would use the particular dose protocol taught by Adedokun in a method of treating Crohn’s disease as claimed by the ‘911 patent given they use an identical IL-23 antibody to treat the same condition and Adedokun discloses the antibody is safe and effective. Furthermore, the ordinary artisan would substitution generic Crohn’s patients as claimed in the ‘911 patent for the Bio-Failure or Con-Failure patients disclosed in Adedokun given these patients have more limited treatment options. While the instant claims are drawn to either particular values of the clinical endpoints these are latent properties of the treatment and therefore are also anticipated by the ‘956 application. The ordinary artisan would find it obvious to treat a group of patients with Crohn’s disease in view of the ‘956 application claiming treating an individual with the same disease. It is noted Adedokun also provides further support for treating a group of patients with the particular ‘295 claimed protocol as well as particular clinical endpoints.
Conclusion
No claim allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HILARY ANN PETRASH whose telephone number is (703)756-4630. The examiner can normally be reached Monday-Friday 8:30-4:30 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached at (571)-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/H.A.P./Examiner, Art Unit 1644 /AMY E JUEDES/Primary Examiner, Art Unit 1644
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