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 .
Non-Final Rejection
The Status of Claims:
Claims 1-12, 15, 18-19, 23, 25, 27 and 33 are pending.
Claims 1-12, 15, 18-19, 25, 27 and 33 are rejected.
Claims 1-2, 4-7,10-11,15,18-19 and 23 are objected.
DETAILED ACTION
1. Claims 1-12, 15, 18-19,23, 25, 27 and 33 are under consideration in this Office Action.
Priority
2. It is noted that this application is a 371 of PCT/JP2022/021531 05/26/2022 has a foreign priority document ,JAPAN JP2021-088034 05/26/2021.
Drawings
3. None.
IDS
4. The IDS filed on 2/15/24, 2/20/24, 1/07/25,4/16/25, 12/15/25 are reviewed by the examiner.
Claim Objections
Claims 1-2, 4-7,10-11,15,18-19 and 23 are objected to because of the following informalities:
In claims, there are some parentheses “(…. )” present. These parentheses can be confusing. The examiner recommends to remove them from the claims.
Appropriate correction is required.
Claim 23 is 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.
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 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.
Claim Rejections - 35 USC § 112
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 1-12, 15, 18-19, 25, 27 and 33 are rejected on the judicially-created basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex Parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). The improper Markush includes species of the claimed invention that do not share both a substantial structural feature and a common use that flows from the substantial structural feature. The members of the improper Markush grouping do not share a substantial feature and /or a common use that flows from the substantial structural feature for the following reasons :
In claims 1, a compound of formula (1) :
PNG
media_image1.png
215
407
media_image1.png
Greyscale
1) or a pharmaceutically acceptable salt thereof, wherein R is optionally-substituted C6-io aromatic carbocyclyl group, optionally-substituted 5- to 10-membered aromatic heterocyclyl group, optionally-substituted C3-6 saturated carbocyclyl group, optionally-substituted 4- to 6-membered saturated heterocyclyl group, or cyano; Li is single bond, methylene (which may be optionally substituted with the same or different one or more Ci-6 alkyl groups), -NR6-, SO-, -So2-, -S-, or oxygen atom;L2 is single bond, methylene (which may be optionally substituted with the same or different one or more Ci-6 alkyl groups), -NR6-, -C(=0)-, -OC(=0)-, -SO-, -So2-, -S-, or oxygen atom;R2 is hydrogen atom, hydroxy group, halogen atom, cyano, optionally-substituted Ci-6 alkyl, optionally-substituted Ci-6 alkoxy, C(=0)NR3R4 or C(=0)O-R5;R3, R4, R5 and R6 are each independently hydrogen atom or optionally-substituted Ci-6 alkyl;ring E is optionally-substituted 5- to 10-membered aromatic heterocyclyl group or optionally-substituted [[4-]]6- to 10-membered saturated heterocyclyl group[[;]], wherein in ring E, the optional substituent of 5- to 10-membered aromatic heterocyclyl group and 6- to 10- membered saturated heterocyclyl group is each independently one or more substituents selected from the group consisting of halogen atom, C1-6 alkyl (which may be optionally substituted withthe same or different one or more substituents selected from halogen atom, hydroxy group, Ci-6 alkoxy or C3-7 cycloalkyl), C6-io aromatic carbocyclyl group (which maybe optionally substituted with the same or different one or more substituents selected from halogen atom,hydroxy group, Ci-6 alkyl, Ci-6 alkoxy or C3-7 cycloalkyl), Ci-6 alkoxy (which may be optionally substituted with the same or different one or more substituents selected from halogen atom,hydroxy group or C3-7 cycloalkyl), C1-6 alkylamino (the alkyl group of which may be optionally substituted with halogen atom, hydroxy group or C3-7 cycloalkyl), C3-7 cycloalkyl (which may be optionally substituted with the same or different one or more substituents selected from halogen atom, hydroxy group, Ci-6 alkyl, Ci-6 alkoxy or C3-7 cycloalkyl), and C3-7 cycloalkoxy (which may be optionally substituted with the same or different one or more substituents selected from halogen atom, hydroxy group, Ci-6 alkyl, Ci-4 alkoxy or C3-7 cycloalkyl), or when there are plural optional substituents, two of them may be taken together via Ci-6 alkylene to forma chemically- possible bicyclic structure selected from a fused ring or bridged ring;ring G is optionally-substituted C6-io aromatic carbocyclyl group, optionally-substituted 5- to 10-membered aromatic heterocyclyl group, optionally-substituted C3-6 saturated carbocyclyl group, or optionally-substituted 4- to 10-membered saturated heterocyclyl group; andA is oxygen atom or sulfur atom.
The variables of R1, G, and E in the formula I are described in the followings:
R1 is at least the following formula (1a-1) to (1a-6) and (1a-21) to (1a-25):
PNG
media_image2.png
493
932
media_image2.png
Greyscale
PNG
media_image3.png
137
698
media_image3.png
Greyscale
wherein the ring G is at least the following formula (1b-1) to (1b-7):
PNG
media_image4.png
344
575
media_image4.png
Greyscale
, wherein the ring E is at least the following formulas:
PNG
media_image5.png
322
621
media_image5.png
Greyscale
.
From the above, it is estimated that the R1 contains at least 11 different compounds; G contains at least 7 different compounds, and E rings contains at least 8 different compounds in combination with their various corresponding substituents in combination with variables R2-R6 which contain numerous substituents of groups; the claim 1 does read on an extremely high number of possible species due to all the permutations and combinations in terms of mathematically speaking. There is no substantial structural feature (for example a common core) shared by all species; furthermore, there is no indication that the species share a specific common on utility.
In response to this rejection, Applicant should either amend the claims to recite only individual species or grouping of species that share a substantial structural feature as well as a common use that flows from the substantial structural feature, or present a sufficient showing that the species recited in the alternative of the claims in a fact share a substantial structural feature as well as a common use that flows from the substantial structural feature. An 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.
5. Claim(s) 1-2, 4-5, 10, 25, 27 and 33 are rejected under 35 U.S.C. 102(a)(2) as being anticipated clearly by Fusimoto et al (JP 2010-155827 A).
Fusimoto et al discloses the compounds in the followings:
.
PNG
media_image6.png
254
364
media_image6.png
Greyscale
(see page 75 , a p aragraph#0339)
PNG
media_image7.png
248
411
media_image7.png
Greyscale
(see page 206, a paragraph#1199, compound#334)
PNG
media_image8.png
234
480
media_image8.png
Greyscale
(see page 228, a paragraph#1360, compound#386)
PNG
media_image9.png
234
461
media_image9.png
Greyscale
(see page 233, a paragraph#1399, compound#399)
PNG
media_image10.png
245
353
media_image10.png
Greyscale
(see page 265 , a paragraph#1671, comopound#486)
PNG
media_image11.png
228
414
media_image11.png
Greyscale
(see page 265 , a paragraph#1671, compound# 486)
PNG
media_image12.png
234
364
media_image12.png
Greyscale
(see page 267 , a paragraph#1681, compound# 489)
PNG
media_image13.png
232
362
media_image13.png
Greyscale
(see page 267 , a paragraph#1684, compound# 490)
PNG
media_image14.png
234
378
media_image14.png
Greyscale
(see page 267 , a paragraph#1687, compound# 491)
PNG
media_image15.png
224
390
media_image15.png
Greyscale
(see page 268 , a paragraph#1690, compound# 492)
PNG
media_image16.png
234
359
media_image16.png
Greyscale
(see page 268 , a paragraph#1693, compound# 493)
PNG
media_image17.png
239
383
media_image17.png
Greyscale
(see page 269 , a paragraph#1696, compound# 494)
PNG
media_image18.png
235
382
media_image18.png
Greyscale
(see page 267 , a paragraph#1699, compound# 495) and their pharmaceutical compositions. These are useful in treating, preventing, relieving,
regulating, or reducing the risk of various neurological and psychiatric disorders associated with orexin receptors, including one or more of the following symptoms or diseases, such as idiopathic insomnia, sleep problems,insomnia, hypersomnia, idiopathic hypersomnia, recurrent hypersomnia, essential hypersomnia, nalcolepsy, intermittent sleep, sleep apnea, wakefulness, nocturnal clonicmuscle spasms, REM sleep interruption, jet lag, sleep disorders in shift workers (see page 110, lines 5-8).
These are identical with the claims.
6. Claim(s) 1-2, 4, 10, 25, 27 and 33 are rejected under 35 U.S.C. 102(a)(2) as being anticipated clearly by Bergman et al (WO 2006/1275550 A1).
Bergman et al discloses the following compounds:
PNG
media_image19.png
239
402
media_image19.png
Greyscale
(see page 64, the last compound)
PNG
media_image20.png
721
246
media_image20.png
Greyscale
(see page 65, compounds)
PNG
media_image21.png
308
341
media_image21.png
Greyscale
PNG
media_image22.png
187
353
media_image22.png
Greyscale
PNG
media_image23.png
174
395
media_image23.png
Greyscale
PNG
media_image24.png
201
382
media_image24.png
Greyscale
(see page 66 , the second, fourth, fifth, and sixth compounds)
PNG
media_image25.png
557
444
media_image25.png
Greyscale
(see page 67, the third and fourth compounds)
PNG
media_image26.png
270
362
media_image26.png
Greyscale
(see page 68, the first compound)
PNG
media_image27.png
211
390
media_image27.png
Greyscale
(see page 73, the first compound) and their pharmaceutical compositions.
These compounds can be used to treat sleep apnea; narcolepsy; insomnia; parasomnia (see page 2 ,lines 6-7). These are identical with the claims.
7. Claim(s) 1, 2, 5-7, 9, 25-27 are rejected under 35 U.S.C. 102(a)(2) as being anticipated clearly by Urbanski et al (WO 02/055514 A1).
Urbanski et al discloses the following compounds:
PNG
media_image28.png
188
377
media_image28.png
Greyscale
(see page 97,, compound#49)
PNG
media_image29.png
223
438
media_image29.png
Greyscale
(see page 98, compound#62)[AltContent: rect]
PNG
media_image30.png
235
469
media_image30.png
Greyscale
(see page 110, compound#127)
PNG
media_image31.png
230
476
media_image31.png
Greyscale
(see page 117, compound#162) and their pharmaceutical compositions. These compounds can be used to treat the disorders of sleep and other circadian rhythms(see page 8, lines 29-30). These are identical with the claims.
8. Claim(s) 1-2, 4-5, 10,25 are rejected under 35 U.S.C. 102(a)(2) as being anticipated clearly by Basson et al (WO 2019/199353 A1).
Basson et al discloses compounds and their pharmaceutical compositions in the followings:
PNG
media_image32.png
653
638
media_image32.png
Greyscale
PNG
media_image33.png
534
612
media_image33.png
Greyscale
PNG
media_image34.png
535
558
media_image34.png
Greyscale
PNG
media_image35.png
539
558
media_image35.png
Greyscale
(see pages 9-11, compounds# III-VI, page 27 table 1 ). These are identical with the claims.
9. Claim(s) 1-2, 4-5, 10, and 25 are rejected under 35 U.S.C. 102(a)(2) as being anticipated clearly by Harris et al (US 2008/0070892 A1).
Harris et al discloses a compound and its pharmaceutical compositions in the following:
PNG
media_image36.png
259
416
media_image36.png
Greyscale
IT 1025045-10-6PRL: PAC (Pharmacological activity); SPN (Synthetic preparation); THU(Therapeutic use); BIOL (Biological study); PREP (Preparation); USES(Uses)(prepn. of spiro(azetidine-piperidine) derivs. as GPR119 modulatorsuseful in the treatment of diabetes, pain and lipid metab. disorders)RN 1025045-10-6 HCAPLUS CN 2,7-Diazaspiro[3.5]nonane-2-carboxamide,N-[1,1'-biphenyl]-2-yl-7-[(4-methyl-1,2,3-thiadiazol-5-yl)carbonyl]-1-phenyl- (CA INDEX NAME) (see abstract page ). These are identical with the claims.
10. Claim(s) 1. 2. 4-7. 9 are rejected under 35 U.S.C. 102(a)(2) as being anticipated clearly by Mandelkow et al l (WO 2006/007864 Al).
Mandelkow et al discloses the following compound.
PNG
media_image37.png
190
677
media_image37.png
Greyscale
(see page 76, compound#272) This is identical with the claims.
11. Claim(s) 1,2, 5,9,11, 25 are rejected under 35 U.S.C. 102(a)(2) as being anticipated clearly by Wang et al (ACS Medicinal Chemistry Letters. 16 February 2021. vol. 12. no. 3. pp. 356-364).
Wang et al discloses compounds and their pharmaceutical composition thereof n the followings:
PNG
media_image38.png
539
936
media_image38.png
Greyscale
PNG
media_image39.png
626
1040
media_image39.png
Greyscale
PNG
media_image40.png
392
1072
media_image40.png
Greyscale
These are identical with the claims.
12. Claim(s) 1-2,4-5, 9-10, 25 are rejected under 35 U.S.C. 102(a)(2) as being anticipated clearly by Ko et al (WO 00/35877).
Ko et al discloses compounds and their pharmaceutical composition in the followings:
PNG
media_image41.png
356
599
media_image41.png
Greyscale
(see page 138, table 1)
PNG
media_image42.png
29
741
media_image42.png
Greyscale
PNG
media_image43.png
207
581
media_image43.png
Greyscale
(see page 138, entry# 1-11)
PNG
media_image44.png
287
824
media_image44.png
Greyscale
(see page 139, entry# 38-49)
PNG
media_image45.png
293
810
media_image45.png
Greyscale
(see page 140, entry#87-98). These are identical with the claims.
13. Claim(s) 1-2,4-7, 9-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated clearly by CAS (RN#275810-68-9, enter date on July 10, 2000).
CAS (RN#275810-68-90) discloses the following compound:
PNG
media_image46.png
245
711
media_image46.png
Greyscale
PNG
media_image47.png
322
580
media_image47.png
Greyscale
This is identical with the claims.
14. Claim(s) 1-2,4-7, 9-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated clearly by CAS (RN#275810-67-8, enter date on July 10, 2000).
CAS (RN#275810-67-8) discloses the following compound:
PNG
media_image48.png
92
675
media_image48.png
Greyscale
PNG
media_image49.png
469
729
media_image49.png
Greyscale
This is identical with the claims.
15. Claim(s) 1-2,4-7, 9-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated clearly by CAS (RN#275810-69-0, enter date on July 10, 2000).
CAS (RN#275810-69-0) discloses the following compound:
PNG
media_image50.png
496
707
media_image50.png
Greyscale
This is identical with the claims.
16. Claim(s) 1-2,4-7, 9-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated clearly by CAS (RN#275810-64-5, enter date on July 10, 2000).
CAS (RN#275810-64-5) discloses the following compound:
PNG
media_image51.png
474
698
media_image51.png
Greyscale
This is identical with the claims.
Conclusion
Claims 1-12, 15, 18-19, 25, 27 and 33 are rejected.
Claims 1-2, 4-7,10-11,15,18-19 and 23 are objected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAYLOR V OH whose telephone number is (571)272-0689. The examiner can normally be reached 8:00-5:00.
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, Andrew Kosar can be reached at 571-272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/TAYLOR V OH/Primary Examiner, Art Unit 1625 4/12/2026