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 1-33 are pending in the instant application and subject to examination herein.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 08/15/2024, 08/16/2024 and 08/19/2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Objections
Claims 23-24 are objected to because of the following informalities: each of claims 23-24 contains a redundancy in the list of elements of the disclosed Markush group(s): claim 23 includes the element “imidazopyrazinyl” twice in the same Markush group listing, and claim 24 includes the element “imidazo[l,5-a]pyrazin-8-yl” twice in the same Markush group listing. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 5, 13, 30 and 32 are anticipated by Kelly.
Claims 1, 5, 13, 30 and 32 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Kelly (WO 2020/205683 A1)1.
Claim 1 is drawn to a genus of spirocyclic imidazolidinones bearing pendant aryl and/or heteroaryl rings with specific limitations on the groups linking the aryl/heteroaryl rings to the spirocyclic core, as shown in the table below. Kelly discloses a compound 1582 that anticipates the genus of instant formula I, as shown in the table below (page 41):
Claim Number(s) of Instant Application
Instant Application
Kelly
1
PNG
media_image1.png
154
390
media_image1.png
Greyscale
wherein:
PNG
media_image2.png
372
528
media_image2.png
Greyscale
Thus, claim 1 is anticipated by the disclosure of Kelly.
Claims 5 and 13 further limit claim 1, each to a narrower genus of compounds that is met by the disclosure of Kelly’s compound 158.
Claim 30 further limits claim 1 to a pharmaceutical composition comprising a compound of claim 1 and a pharmaceutically acceptable carrier. Kelly discloses a pharmaceutical composition comprising a compound disclosed therein in admixture with a pharmaceutically acceptable carrier (paragraph [0060]).
Claim 32 further limits claim 1 to a method of treating light chain amyloidosis in a subject, comprising administering to the subject a compound of claim 1. Kelly discloses a method of light chain amyloidosis in a patient, comprising administering to the patient an effective amount of any compound described therein (paragraph [0008]).
Thus, claims 5, 13, 30 and 32 are anticipated by the disclosure of Kelly.
Claims 1, 7-9, 15, 18-21, 25-26, 28 and 30-31 are anticipated by Quattropani.
Claims 1, 7-9, 15, 18-21, 25-26, 28 and 30-31 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Quattropani (WO 2020/039029 A1)3.
The limitations of claims 1 and 30 are discussed in the rejection above and hereby incorporated into the instant rejection.
Quattropani discloses multiple compounds that anticipate the genus of claim 1, including for example Quattropani’s compounds IA34, 325 and 406 as shown in the table below (pages 17, 44 and 47, respectively):
Claim Number(s) of Instant Application
Instant Application
Quattropani
1
PNG
media_image1.png
154
390
media_image1.png
Greyscale
wherein:
PNG
media_image3.png
210
352
media_image3.png
Greyscale
Compound IA3
1
PNG
media_image1.png
154
390
media_image1.png
Greyscale
wherein:
PNG
media_image4.png
146
266
media_image4.png
Greyscale
Compound 32
1
PNG
media_image1.png
154
390
media_image1.png
Greyscale
wherein:
PNG
media_image5.png
290
422
media_image5.png
Greyscale
Compound 40
Thus, claim 1 is anticipated by the disclosure of Quattropani.
Claim 7 further limits claim 1 to wherein R1 is selected from a Markush group that includes pyridiyl, pyrimidinyl and phenyl, optionally substituted with methyl and/or cyano group(s), and is met by compounds 32 and 40 disclosed by Quattropani.
Claim 8 further limits claim 1 to wherein R1 is selected from a Markush group that includes pyrimidinyl, and is met by compound 40 disclosed by Quattropani.
Claim 9 further limits claim 1 to wherein R1 is selected from a Markush group that includes 4-cyanophenyl, and is met by compound 32 disclosed by Quattropani.
Thus, claims 7-9 are anticipated by the disclosure of Quattropani.
Claim 15 is drawn to a genus of spirocyclic imidazolidinediones bearing pendant aryl and/or heteroaryl rings with specific limitations on the groups linking the aryl/heteroaryl rings to the spirocyclic core, as shown in the table below. Quattropani discloses multiple compounds that anticipate the genus of claim 15, for example Quattropani’s compounds IA17, 58 and 139, shown in the table below (pages 17, 35 and 38, respectively):
Claim Number(s) of Instant Application
Instant Application
Quattropani
15
PNG
media_image6.png
156
478
media_image6.png
Greyscale
wherein:
PNG
media_image7.png
164
392
media_image7.png
Greyscale
Compound IA1
15
PNG
media_image6.png
156
478
media_image6.png
Greyscale
wherein:
PNG
media_image8.png
332
586
media_image8.png
Greyscale
Compound 5
15
PNG
media_image6.png
156
478
media_image6.png
Greyscale
wherein:
PNG
media_image9.png
230
482
media_image9.png
Greyscale
Compound 13
Thus, claim 15 is anticipated by the disclosure of Quattropani.
Claim 18 and 28 further limit claim 15, each to a narrower genus of compounds that is met by Quattropani’s compound IA1.
Claims 19 and 26 further limit claim 15, each to a narrower genus of compounds that is met by Quattropani’s compounds IA1, 5 and 13.
Claim 21 further limits claim 15 to a narrower genus of compounds that is met by Quattropani’s compound 13.
Claim 25 further limit claim 15, each to a narrower genus of compounds that is met by Quattropani’s compounds IA1 and 5.
Claim 26 further limits claim 15 to a narrower genus of compounds that is met by Quattropani’s compounds 5 and 13.
Claim 30 further limits claim 1 to a pharmaceutical composition comprising a compound of claim 1 and a pharmaceutically acceptable carrier. Claim 31 further limits claim 15 to a pharmaceutical composition comprising a compound of claim 15 and a pharmaceutically acceptable carrier. Quattropani discloses that the invention disclosed therein relates to a pharmaceutical composition comprising as active ingredient an effective amount of at least one compound disclosed therein according to the invention and/or physiologically acceptable salts thereof together with pharmaceutically tolerable adjuvants and/or excipients (page 93, lines 11-14).
Thus, claims 18-19, 21, 25-26, 28 and 30-31 are anticipated by the disclosure of Quattropani.
Claims 15, 17, 28 and 31 are anticipated by Cowley.
Claims 15, 17, 28 and 31 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Cowley (WO 2016/071293 A2)10.
The limitations of claims 15, 28 and 31 are discussed in the rejection above and hereby incorporated into the instant rejection.
Cowley discloses multiple compounds that anticipate the genus of instant formula II as claimed in claim 15, including for example Cowley’s compound 40711, shown in the table below (page 237):
Claim Number(s) of Instant Application
Instant Application
Cowley
15
PNG
media_image6.png
156
478
media_image6.png
Greyscale
wherein:
PNG
media_image10.png
174
136
media_image10.png
Greyscale
Thus, claim 15 is anticipated by the disclosure of Cowley.
Claims 17 and 28 further limit claim 15, each to a narrower genus that is met by Cowley’s compound 407.
Regarding claim 31, Cowley provides a pharmaceutical composition comprising a compound disclosed therein and a pharmaceutically acceptable additive and/or excipient (pages 244-245, bridging paragraph).
Thus, claims 17, 28 and 31 are anticipated by the disclosure of Cowley.
Claims 15, 18-21 and 25-28 are anticipated by CAS 941970-37-2.
Claims 15, 18-21 and 25-28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CAS 941970-37-2 (Chemical Abstracts Services, registry number 941970-37-2, originally entered on 07/10/2007 by Life Chemicals, Inc.).
The limitations of claims 15, 18-19, 21, 25-26 and 28 are discussed in the rejections above and hereby incorporated into the instant rejection.
CAS 941970-37-2 discloses a compound12 that anticipates the genus of claim 15, as shown in the table below:
Claim Number(s) of Instant Application
Instant Application
CAS 941970-37-2
15
PNG
media_image6.png
156
478
media_image6.png
Greyscale
wherein:
PNG
media_image11.png
138
330
media_image11.png
Greyscale
Thus, claim 15 is anticipated by the disclosure of CAS 941970-37-2.
Claims 18-21 and 25-28 further limit the genus of compounds of claim 15, each to a narrower genus, and each is met by the compound disclosed by CAS 941970-37-2.
Thus, claims 18-21 and 25-28 are anticipated by the disclosure of CAS 941970-37-2.
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.
The limitations of claims 1 and 15 are discussed in the rejections above and hereby incorporated into the instant rejection below.
Claims 1, 5, 10-11, 13, 15-17, 23-24, 26 and 28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 64 and 130 of copending Application No. 18/494,587 (hereafter referred to as “Qiu”). Although the claims at issue are not identical, they are not patentably distinct from each other because Qiu’s claims 64 and 130 disclose compounds that anticipate the instant formulae I and II of instant claims 1 and 15, for examples Qiu’s compounds 213 and 2514, respectively, as shown in the table below:
Claim Number(s) of Instant Application
Instant Application
Qiu
1
PNG
media_image1.png
154
390
media_image1.png
Greyscale
wherein:
PNG
media_image12.png
274
230
media_image12.png
Greyscale
Compound 2
15
PNG
media_image6.png
156
478
media_image6.png
Greyscale
wherein:
PNG
media_image13.png
260
244
media_image13.png
Greyscale
Compound 25
Instant claims 5, 10-11 and 13 further limit the genus of compounds of instant claim 1, each to a narrower genus that is anticipated by Qiu’s compound 2 of Qiu’s claim 64.
Instant claims 16-17, 23-24, 26 and 28 further limit the genus of compounds of instant claim 15, each to a narrower genus that is anticipated by Qiu’s compound 25 of Qiu’s claim 130.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The limitations of claims 1 and 15 are discussed in the rejections above and hereby incorporated into the instant rejection below.
Claims 1-3, 6, 10-11, 13, 15-17, 22-24, 26 and 28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 43 and 86 of copending Application No. 18/494,601 (hereafter referred to as “Protego”). Although the claims at issue are not identical, they are not patentably distinct from each other because because Protego’s claims 43 and 86 disclose compounds that anticipate the instant formulae I and II of instant claims 1 and 15, for examples Protego’s compounds 315 and 2616, respectively, as shown in the table below:
Claim Number(s) of Instant Application
Instant Application
Protego
1
PNG
media_image1.png
154
390
media_image1.png
Greyscale
wherein:
PNG
media_image14.png
680
380
media_image14.png
Greyscale
Compound 3
15
PNG
media_image6.png
156
478
media_image6.png
Greyscale
wherein:
PNG
media_image15.png
628
336
media_image15.png
Greyscale
Compound 26
Claims 2-3, 6, 10-11 and 13 further limit the genus of compounds of claim 1, each to a narrower genus that is met by Protego’s compound 3.
Claims 16-17, 22-24, 26 and 28 further limit the genus of compounds of claim 15, each to a narrower genus that is met by Protego’s compound 26.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Allowable Subject Matter
Claims 4, 12, 14, 29 and 33 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to W. JUSTIN YOUNGBLOOD whose telephone number is (703)756-5979. The examiner can normally be reached on Monday-Thursday from 8am to 5pm. The examiner can also be reached on alternate Fridays.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey S. Lundgren, can be reached at telephone number (571) 272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/W.J.Y./Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
1 Cited in Applicant’s Information Disclosure Statement dated 08/15/2024.
2 3-{2-[7-(diethylamino)-4-methyl-2-oxo-2H-chromen-3-yl]ethyl}-8-phenyl-1,3,8-triazaspiro[4.5]decan-2-one
3 Cited in Applicant’s Information Disclosure Statement dated 08/15/2024.
4 N-[5-({3-[(6-methylpyridin-3-yl)methyl]-2-oxo-1,3,8-triazaspiro[4.5]decan-
8-yl}methyl)-1,3-thiazol-2-yl]acetamide
5 4-({8-[1-(1,3-benzothiazol-5-yl)ethyl]-2-oxo-1,3,8-triazaspiro[4.5]decan-3-yl}methyl)benzonitrile
6 8-[1-(1,3-benzothiazol-5-yl)ethyl]-3-[(pyrimidin-2-yl)methyl]-1,3,8-triazaspiro[4.5]decan-2-one
7 N-{5-[(2,4-dioxo-3-{[6-(trifluoromethyl)pyridin-3-yl]methyl}-1,3,8-triazaspiro[4.5]decan-8-yl)methyl]-1,3-thiazol-2-yl}acetamide
8 8-[1-(1,3-benzothiazol-5-yl)ethyl]-3-[(pyrimidin-5-yl)methyl]-1,3,8-triazaspiro[4.5]decane-2,4-dione
9 4-({8-[1-(1,3-benzothiazol-5-yl)ethyl]-2,4-dioxo-1,3,8-triazaspiro[4.5]decan-3-yl}methyl)benzonitrile
10 Cited in Applicant’s Information Disclosure Statement dated 08/15/2024.
11 8-(6-chloro-1H-indazol-4-yl)-3-[(1,3-oxazol-2-yl)methyl]-1,3,8-triazaspiro[4.5]decane-2,4-dione
12 2,4-Dioxo-N-(2-phenylethyl)-8-(phenylmethyl)-1,3,8-triazaspiro[4.5]decane-3-acetamide
13 3-(2-{4-[(3S)-3-ethyl-3-phenylpyrrolidin-1-yl]-6-methyl-2-oxo-1,2-dihydropyridin-1-yl}ethyl)-8-{imidazo[1,5-a]pyrazin-8-yl}-1,3,8-triazaspiro[4.5]decan-2-one
14 8-{imidazo[1,5-a]pyrazin-8-yl}-3-(2-{6-methyl-4-[(3R)-3-methyl-3-phenylpyrrolidin-1-yl]-2-oxo-1,2-dihydropyridin-1-yl}ethyl)-1,3,8-triazaspiro[4.5]decane-2,4-dione
15 N-[2-(8-{imidazo[1,5-a]pyrazin-8-yl}-2-oxo-1,3,8-triazaspiro[4.5]decan-3-yl)ethyl]-3-methyl-5-[(3R)-3-methyl-3-phenylpyrrolidin-1-yl]pyridine-2-carboxamide
16 3-{2-[3-methyl-5-(3-methyl-3-phenylpyrrolidin-1-yl)pyridin-2-yl]ethyl}-8-(pyrimidin-2-yl)-1,3,8-triazaspiro[4.5]decane-2,4-dione