DETAILED ACTION
The present application is being examined under the pre-AIA first to invent provisions. Claims 24, 26-31, 33-39, 41-50, 52-57, 59-61 and 64-65 are pending in this application.
Response to Amendment
Applicant’s amendment filed 05/13/2026 in response to the previous Office Action (02/13/2026) is acknowledged. The nonstatutory double patenting rejection (items 5-9) has been maintained and modified to address applicant’s argument. During a review of the case, the examiner came across another patent family (13/206,113 now U.S. Pat. No. 8,575,154), (13/774,707, now U.S. Pat. No. 8,916,551), and (13/774,635, now U.S. Pat. No. 8,778,934) that claim the three excluded compounds recited in claim 11 of the parent case 13/816,137 (U.S. Pat. No. 9,150,591).
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Note that cases 13/774,707 and 13/774,635 are divisional cases of 13/206,113 and have the same specification with the instant case.
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Since the examiner is including a new nonstatutory double patenting rejection over U.S. Patent No. 8,778,934, this Office Action would not be made Final. Note that patent ‘934 claims the third excluded compound: 9-[4-(cyclohexyloxy)phenyl]-7-methyl-3,4-dihydropyrazino[2,1-c][1,2,4]thiadiazines 2,2-dioxide that is the same as the claimed compound.
Election/Restrictions
Applicant’s election with traverse of Group I in the reply filed on 01/12/2026 is acknowledged. Upon further review of the case, it is deemed necessary to withdraw the Restriction Requirement dated on 10/17/2025.
Information Disclosure Statement
4. Applicant’s Information Disclosure Statement, filed on 05/13/2026 has been acknowledged. Please refer to Applicant’s copies of the 1449 submitted herewith.
Double Patenting
5. 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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this 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 §§ 706.02(l)(1) - 706.02(l)(3) 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/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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
6. Claims 24, 26-31, 33-39, 41-50, 52-57, 59-61 and 64-65 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Patent No. 9,150,591. Although the claims at issue are not identical, they are not patentably distinct from each other because there is overlap between applicants' claims and claims 1-29 of U.S. Patent No. 9,150,591. Note that patent ‘591 is drawn to a method of treatment that are the same as applicants. It is also obvious for one skilled in the art to use a crystalline form of 9-[4-(cyclohexyloxy)phenyl]-7-methyl-3,4-dihydropyrazino[2,1-c][1,2,4]thiadiazines 2,2-dioxide that is disclosed in the specification and use it to improve the therapeutic effect of the compound. The obviousness-type double patenting rejection is proper because this case is a continuation case and the specification of patent ‘591 discloses the claimed subject matter.
Response to arguments
Applicant’s argument filed 05/13/2026 has been fully considered but it is not persuasive.
Applicants argue that “The claims of the Reference Patents Do Not Teach or Suggest the Subject Matter of the Pending Claims”, but the examiner disagrees with applicant’s argument. The pending claims are drawn to a crystalline form of 9-[4-(cyclohexyloxy)phenyl]-7-methyl-3,4-dihydropyrazino[2,1-c][1,2,4]thiadiazines 2,2-dioxide compound that is disclosed in the specification of all patents. In patent ‘591 for example, applicants disclosed a crystalline compound of the claimed compound with the exact X-ray diffraction data at column 178 (Example 169).
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Thus, applicant’s argument “the patents do not suggest or teach the subject matter of the instant claims” i.e. crystalline form of 9-[4-(cyclohexyloxy)phenyl]-7-methyl-3,4-dihydropyrazino[2,1-c][1,2,4]thiadiazines 2,2-dioxide compound is not valid. The examiner disagrees with applicant’s argument that “the Office has not established how any claim in the reference patents teaches or suggests a crystalline form of 9-[4-(cyclohexyloxy)phenyl]-7-methyl-3,4-dihydropyrazino[2,1-c][1,2,4]thiadiazines 2,2-dioxide.” The X-ray diffraction data in the specification for compound 9-[4-(cyclohexyloxy)phenyl]-7-methyl-3,4-dihydropyrazino[2,1-c][1,2,4]thiadiazines 2,2-dioxide are for the crystalline form and nothing else.
Note that applicants filed a terminal disclaimer over three patents (U.S. Patent No. 9,884,875, U.S. Patent No. 10,654,874, and U.S. Patent No. 11,279,713) to overcome an obviousness type double patenting rejection previously. In this instant case, applicants are arguing the nonstatutory double patenting rejections and are not willing to file a terminal disclaimer.
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Applicants argue that “the nonstatutory double patenting assessment requires comparing the claims of the application under examination against the claims of the reference application(s) or patent(s)….the Office has not properly performed assessment.” The examiner disagrees with applicant’s argument. Applicants are not claiming different compound from what was claimed in the parent case 13/816,137 (now Patent 9,150,591). It is recommended that applicants file a terminal disclaimer to overcome this rejection.
7. Claims 24, 26-31, 33-39, 41-50, 52-57, 59-61 and 64-65 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 9,499,568. Although the claims at issue are not identical, they are not patentably distinct from each other because there is overlap between applicants' claims and claims 1-17 of U.S. Patent No. 9,499,568. Note that patent ‘568 is drawn to a method of treatment of Alzheimer’s disease that is the same as applicants (see for example instant claim 50). The instant claims are drawn to a crystalline form of 9-[4-(cyclohexyloxy)phenyl]-7-methyl-3,4-dihydropyrazino[2,1-c][1,2,4]thiadiazines 2,2-dioxide compound that is embraced by formula (I) of claim 1 of patent ‘568. Since the crystalline form of 9-[4-(cyclohexyloxy)phenyl]-7-methyl-3,4-dihydropyrazino[2,1-c][1,2,4]thiadiazines 2,2-dioxide of the compound is disclosed in the specification of said patent, it is obvious for one skilled in the art to use the crystalline compound to enhance the therapeutic purpose of the compound. The obviousness-type double patenting rejection is proper because this case is a continuation case and the specification of patent ‘568 discloses the claimed subject matter.
Response to arguments
Applicant’s argument filed 05/13/2026 has been fully considered but it is not persuasive.
Please see the argument in paragraph 6 above. In addition to the above arguments raised in paragraph 6, the examiner modified this rejection to address applicant’s argument.
8. Claims 24, 26-31, 33-39, 41-50, 52-57, 59-61 and 64-65 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 9,884,875. Although the claims at issue are not identical, they are not patentably distinct from each other because there is overlap between applicants' claims and claim 1 of U.S. Patent No. 9,884,875. Note that patent ‘875 is drawn to a method of treatment using 9-[4-(cyclohexyloxy)phenyl]-7-methyl-3,4-dihydropyrazino[2,1-c][1,2,4]thiadiazines 2,2-dioxide compound that is the same as applicants. Note that patent ‘875 recite in claim 1 a method for treating depression, schizophrenia or attention deficit hyperactivity disorder Alzheimer’s disease that is the same as the instant claims 39 and 50. Since the crystalline form of 9-[4-(cyclohexyloxy)phenyl]-7-methyl-3,4-dihydropyrazino[2,1-c][1,2,4]thiadiazines 2,2-dioxide of the compound is disclosed in the specification of said patent, it is obvious for one skilled in the art to use the crystalline compound to enhance the therapeutic purpose of the compound. The obviousness-type double patenting rejection is proper because this case is a continuation case and the specification of patent ‘875 discloses the claimed subject matter.
Response to arguments
Applicant’s argument filed 05/13/2026 has been fully considered but it is not persuasive.
Please see the argument in paragraph 6 above. In addition to the above arguments raised in paragraph 6, the examiner modified this rejection to address applicant’s argument.
9. Claims 24, 26-31, 33-39, 41-50, 52-57, 59-61 and 64-65 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 10,654,874. Although the claims at issue are not identical, they are not patentably distinct from each other because there is overlap between applicants' claims and claims 1-3 of U.S. Patent No. 10,654,874. Note that patent ‘874 recite in claim 1 a method for treating cognitive impairment associated with schizophrenia using 9-[4-(cyclohexyloxy)phenyl]-7-methyl-3,4-dihydropyrazino[2,1-c][1,2,4]thiadiazines 2,2-dioxide compound that is the same as the instant claims 39 and 50. Since the crystalline form of 9-[4-(cyclohexyloxy)phenyl]-7-methyl-3,4-dihydropyrazino[2,1-c][1,2,4]thiadiazines 2,2-dioxide of the compound is disclosed in the specification of said patent, it is obvious for one skilled in the art to use the crystalline compound to enhance the therapeutic purpose of the compound. The obviousness-type double patenting rejection is proper because this case is a continuation case and the specification of patent ‘874 discloses the claimed subject matter.
Response to arguments
Applicant’s argument filed 05/13/2026 has been fully considered but it is not persuasive.
Please see the argument in paragraph 6 above. In addition to the above arguments raised in paragraph 6, the examiner modified this rejection to address applicant’s argument.
10. Claims 24, 26-31, 33-39, 41-50, 52-57, 59-61 and 64-65 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 11,279,713. Although the claims at issue are not identical, they are not patentably distinct from each other because there is overlap between applicants' claims and claims 1-5 of U.S. Patent No. 11,279,713. Note that patent ‘713 recite in claim 1 9-[4-(cyclohexyloxy)phenyl]-7-methyl-3,4-dihydropyrazino[2,1-c][1,2,4]thiadiazines 2,2-dioxide compound that is the same as the instant claim 24. Since the crystalline form of 9-[4-(cyclohexyloxy)phenyl]-7-methyl-3,4-dihydropyrazino[2,1-c][1,2,4]thiadiazines 2,2-dioxide of the compound is disclosed in the specification of said patent, it is obvious for one skilled in the art to use the crystalline compound to enhance the therapeutic purpose of the compound. The obviousness-type double patenting rejection is proper because this case is a continuation case and the specification of patent ‘713 discloses the claimed subject matter.
Response to arguments
Applicant’s argument filed 05/13/2026 has been fully considered but it is not persuasive.
Please see the argument in paragraph 6 above. In addition to the above arguments raised in paragraph 6, the examiner modified this rejection to address applicant’s argument.
11. Claims 24, 26-31, 33-39, 41-50, 52-57, 59-61 and 64-65 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of U.S. Patent No. 8,778,934. Although the claims at issue are not identical, they are not patentably distinct from each other because there is overlap between applicants' claims and claims 1-2 of U.S. Patent No. 8,778,934. Note that patent ‘934 recite in claim 1 a 9-[4-(cyclohexyloxy)phenyl]-7-methyl-3,4-dihydropyrazino[2,1-c][1,2,4]thiadiazines 2,2-dioxide compound that is the same as instant claim 24. The obviousness-type double patenting rejection is proper because this case is a continuation case and the specification of patent ‘934 discloses a crystalline form of the compound with the exact X-ray powder diffraction data and melting point.
Conclusion
12. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kahsay Habte Ph.D. whose telephone number is (571)272-0667. The examiner can normally be reached on 8:30 - 5:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JEFFREY MURRAY can be reached on 571-272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Kahsay Habte/
Primary Examiner, Art Unit 1624
Prosecution Insights