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 .
DETAILED ACTION
Status of Claims
Claims 59-78 are pending and under examination in this office action.
Priority
The instant application 18/974,778 filed on December 09, 2024 is a continuation of U.S. Patent Application Serial No. 18/621,023 (now U.S. Patent No. 12,201,638) filed March 28, 2024, which is a continuation of U.S. Application No. 16/975,292 (now U.S. Patent No. 12,059,424), filed August 24, 2020, which is a national stage of International Patent Application No. PCT/EP2019/055138, filed March 1, 2019, which claims priority from U.S. Provisional Patent Application No. 62/636,944, filed March 1, 2018.
Information Disclosure Statement
The information disclosure statement filed on December 18, 2025 is considered. The copy of foreign patent document and non-patent literature publication not in English provided in parent application Nos.16/975,292 and 18/621,023, are considered to the degree of English abstract and/or patent family of foreign patent.
Claim interpretation
Compound A , (2S)-N-[(1S)-1-Cyano-2-[4-(3-methyl-2-oxo-2,3-dihydro-1,3-benzoxazol-5-yl)phenyl]ethyl]-1,4-oxazepane-2-carboxamide, is also known as INS1007 or AZD7986 as disclosed in instant specification([0094]). AZD7986, also known by its generic name brensocatib (Brinsupri) was approved by FDA on August 12, 2025 for treating non-cystic fibrosis bronchiectasis (NCFB) in adults and pediatric patients aged 12 years.
Instantly recited pharmaceutical composition comprising Compound A (i.e. AZD7986 ) in combination with specific excipients at particular range of amount/concentration, (b) from about 55 wt% to about 70 wt% microcrystalline cellulose;(c) from about 18 wt% to about 22 wt% dibasic calcium phosphate dihydrate;(d) from about 3.5 wt% to about 4.5 wt% sodium starch glycolate;(e) from about 0.05 wt% to about 0.50 wt% silicon dioxide; and(f) from about 2 wt% to about 7 wt% glycerol behenate, was allowed in parent applications, now US patent Nos 12,059,424 and 12,201,638.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 59-78 are rejected on the ground of nonstatutory double patenting, as being unpatentable over claims 1-8 of US patent No.12201638, in view of NCT03218917 (V1, available on 07/12/2017, retrieved from https://clinicaltrials.gov).
Reference claims are directed to a pharmaceutical composition comprising Compound A and instantly claimed ingredients at the same amount/concentration,
from about 3 wt % to about 15 wt % of (2S)-N-{(1S)-1-cyano-2-[4-(3-methyl-2-oxo-2,3-dihydro-1,3-benzoxazol-5-yl) phenyl]ethyl}-1,4-oxazepane-2-carboxamide (Compound A);
from about 55 wt % to about 70 wt % microcrystalline cellulose;
from about 18 wt % to about 22 wt % dibasic calcium phosphate dihydrate;
(d) from about 3.5 wt % to about 4.5 wt % sodium starch glycolate;
(e) from about 0.05 wt % to about 0.50 wt % silicon dioxide; and
(f) from about 2.5 wt % to about 7 wt % glycerol behenate;
and wherein the weights of components (a)-(f) add up to 100 wt %.
Reference claims 2-3 recite the composition in tablet form further comprising a tablet coat (which reads on instant claims60-61).
Reference claims 4-8 recite the amount of Compound A is about 5mg to 50mg, e.g. 10mg, 25mg, 40mg, in the pharmaceutical composition (which reads on instant claims 62-71).
Although reference claims are silent about treating non-cystic fibrosis (CF) bronchiectasis in a patient and administered orally once daily, reference patent expressly discloses use of pharmaceutical composition comprising Compound A for treating non-cystic fibrosis (CF) bronchiectasis in a patient and administered orally once daily (See Col. 18, lines 38-46; Col. 20, lines 23- 27, etc.). A person of ordinary skilled artisan would have recognized the use of treating non-cystic fibrosis (CF) bronchiectasis with composition comprising Compound A are already claimed in the reference patent.
Further, NCT 03218917 (V1, 2017) discloses a clinical study of INS1007 (i.e. Compound A) in subjects with non-cystic fibrosis bronchiectasis. NCT 03218917 teaches administration of INS1007 (i.e. Compound A) oral tablet at dosages of 10 mg or 25 mg once daily to human subjects (See Study Description).
Thus, instantly claimed method of treating non-cystic fibrosis (CF) bronchiectasis with pharmaceutical composition comprising Compound A is not patentably distinct from reference patent.
Instant application is a continuation of reference patent, thus no 35 USC 121 shield exists.
Claims 59-78 are rejected on the ground of nonstatutory double patenting, as being unpatentable over claims 1-8 of US patent No. 12059424, in view of NCT03218917 (V1, available on 07/12/2017, retrieved from https://clinicaltrials.gov).
Reference claims are directed to a pharmaceutical composition comprising Compound A and instantly claimed excipients at similar or narrower range of amount/concentration,
from about 3 wt % to about 10 wt % of (2S)-N-{(1S)-1-cyano-2-[4-(3-methyl-2-oxo-2,3-dihydro-1,3-benzoxazol-5-yl) phenyl]ethyl}-1,4-oxazepane-2-carboxamide (Compound A);
from about 55 wt % to about 70 wt % microcrystalline cellulose;
from about 18 wt % to about 22 wt % dibasic calcium phosphate dihydrate;
(d) from about 3.5 wt % to about 4.5 wt % sodium starch glycolate;
(e) from about 0.05 wt % to about 0.25 wt % silicon dioxide; and
(f) from about 2.5 wt % to about 4.5 wt % glycerol behenate;
and wherein the weights of components (a)-(f) add up to 100 wt %.
Reference claims 2-3 recite the composition in tablet form further comprising a tablet coat (which reads on instant claims60-61).
Reference claims 4-8 recite the amount of Compound A is about 5mg to 50mg, e.g. 10mg, 25mg, 40mg, in the pharmaceutical composition (which reads on instant claims 62-71).
Although reference claims are silent about treating non-cystic fibrosis (CF) bronchiectasis in a patient and administered orally once daily, reference patent expressly discloses use of pharmaceutical composition comprising Compound A for treating non-cystic fibrosis (CF) bronchiectasis in a patient and administered orally once daily (See Col. 18, lines 38-46; Col. 20, lines 24- 28, etc.). A person of ordinary skilled artisan would have recognized the use of treating non-cystic fibrosis (CF) bronchiectasis with composition comprising Compound A are already claimed in the reference patent.
Further, NCT 03218917 (V1, 2017) discloses a clinical study of INS1007 (i.e. Compound A) in subjects with non-cystic fibrosis bronchiectasis. NCT 03218917 teaches administration of INS1007 (i.e. Compound A) oral tablet at dosages of 10 mg or 25 mg once daily to human subjects (See Study Description).
Thus, instantly claimed method of treating non-cystic fibrosis (CF) bronchiectasis with pharmaceutical composition comprising Compound A is not patentably distinct from reference patent.
Instant application is a continuation of reference patent, thus no 35 USC 121 shield exists.
Claims 59 and 72 are rejected on the ground of nonstatutory double patenting, as being unpatentable over claims 1-14 of US 9,815,805. Although the claims at issue are not identical, they are not patentably distinct from each other.
Reference claims are drawn to method of treating obstructive disease of airway with therapeutically effective amount of compound of formula(I) or a pharmaceutically acceptable salt thereof, wherein one species is compound A of instant application. Reference claim 7 is further directed to pharmaceutical compositions comprising compound of formula I and pharmaceutical acceptable adjuvant, diluent or carrier. Reference claim 14 recites oral administration.
Reference claims are silent about the excipients as recited in instant claims and amount/concentration thereof. Selection and optimization of pharmaceutical excipients for known active compound would have been within the ordinary skill in the art. A skilled artisan would have been motivated to explore /optimize different excipients to obtain suitable formulation of Compound A for its known use of treating obstructive disease of airway, e.g. bronchiectasis. Thus, instant claimed method of treating bronchiectasis is obvious variation of reference patent.
The instant application shares at least one common inventor and applicant with the reference patent. Further, the instant application is not related to the reference patent, thus no 35 USC 121 shield exists. See MPEP 804.01.
Claims 59 and 72 are rejected on the ground of nonstatutory double patenting as being unpatentable over the reference claims of following U.S. Patent Nos.
US10669245(Claims 1-16);
US10287258 (Claims 1-6);
US11655221 (Claims 1-22);
US11655222 (Claims 1-20);
US11655223 (Claims 1-21) ;
US11655224 (Claims 1-20);
US11673871 (Claims 1-20);
US11673872 (Claims 1-14);
US11680049 (Claims 1-14);
US11773069 (Claims 1-23);
US11814359 (Claims 1-21);
US12054465 (Claims 1-21).
Although the claims at issue are not identical, they are not patentably distinct from each other. Reference claims cited above are drawn to method of treating obstructive disease of airway (e.g. bronchiectasis) in a patient in need thereof, comprising orally administering pharmaceutical compositions comprising Compound A.
Reference claims are silent about the excipients as recited in instant claims and amount/concentration thereof. Selection and optimization of pharmaceutical excipients for known active compound would have been within the ordinary skill in the art. A skilled artisan would have been motivated to explore /optimize different excipients to obtain suitable formulation of Compound A for its known use of treating obstructive disease of airway, e.g. bronchiectasis. Thus, instant claimed method of treating bronchiectasis is obvious variation of reference patent.
The instant application shares at least one common inventor and applicant with the reference patent. Further, the instant application is not related to the reference patent, thus no 35 USC 121 shield exists. See MPEP 804.01.
Conclusion
No claims are allowed
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/LIYUAN MOU/ Examiner, Art Unit 1628
/JARED BARSKY/Primary Examiner, Art Unit 1628
