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 Application
This Office Action is in response to applicant’s arguments filed on 3/30/26. Claims 1 and 22 have been cancelled. Claims 2-21, 23 are pending. Claims 11-12, 15-16 have been amended. Claims 2 and 8 have been withdrawn. Claims 2-10, 13-14, 17-21, 23 are examined herein.
The claim amendments have rendered 112 rejection of the last Office Action moot, therefore hereby withdrawn.
Applicant’s arguments with regard to the double patenting rejections have been fully considered but found not persuasive, therefore maintained for reasons of record and repeated below for Applicant’s convenience.
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 2-10, 13-14, 17-21, 23 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over the claims of the following patents and applications, each in view of Harris et al. (“Neuropsychological and psychiatric outcomes in encephalitis: A multi-centre case-control study,” PLOS ONE, 2020, 15(3): e0230436, pages 1-24, of record) and Granerod et al. (“Causes of encephalitis and differences in their clinical presentations in England: a multicentre, population-based prospective study,” Lancet Infect. Dis. 2010, 10: 835-44, of record).
US Patents:
9,956,227
11,026,951
11,052,083
11,680,065
11,806,348
11,958,852
11,980,617
12,090,155
12,144,808
12,268,686
12,409,176
12,414,948
12,478,623
US Patent Applications:
17/245,939
18/481,168
18/596,349
18/601,923
18/777,765
18/866,978
18/893,190
19/295,514
19/304,556
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims recite a method of treating depression by administering lumateperone in free or pharmaceutically acceptable salt form in combination with other anti-depressive agents, such as SSRIs, in a tablet, capsule, or a long-acting injectable formulation at the claimed dosages.
However, the referenced claims do not recite depression specifically resulting from bacterial encephalitis.
Harris et al. teach high rates of depression in subjects suffering from encephalitis (pages 1 and 18). Granerod et al. teach that encephalitis has many causes (background section on page 835), for example toxoplasmosis, rickettsia, mycoplasma, or Borrelia (Panel 2 on page 836).
It would be obvious to one of ordinary skill in the art to administer lumateperone to treat a subject with depression resulting from bacterial encephalitis because it is known in the art that depression is a common symptom in all forms of encephalitis. Therefore, the skilled artisan would have had the same reasonable expectation of success in treating depression by administering lumateperone, whether the depression is caused by encephalitis or not.
It is noted that limitations regarding blood-brain barrier are obvious since all the elemental steps of the method claim have been taught by the reference, therefore will obviously occur. It is also noted that the limitations regarding elevated levels pro-inflammatory cytokines or CRP or depressed levels of anti-inflammatory cytokines are obvious in a subject with depression resulting from encephalitis.
Response to Arguments
Applicant argues that the rejection requires a claim to claim analysis to set forth a proper case for an obviousness type double patenting rejection, therefore has not set a legal grounds of rejection.
This is not persuasive because the rejection clearly states that the referenced claims recite lumateperone for treating depression. At the outset, Applicant does not dispute this. Secondly, Applicant is well aware of all the referenced patents and patent applications, therefore should be obvious which claims teach these limitations. The rejection clearly states what the referenced claims teach and what it is lacking. Applicant is reminded that the secondary references make up for these limitations.
Applicant also argues that the claims are improperly rejected because none of the reference patents teach or suggest administration of a compound of formula I with the intent of treating psychiatric disorders caused by encephalitis.
This is not persuasive because Applicant is reminded that the rejections are not made alone but in combination over two secondary references. It is precisely the Harris and Granerod et al. references that teach the nexus between depression and encephalitis. In response to applicant’s arguments against the references, one cannot show nonobviousness by attacking references individually where the rejections are based on the combination of references. See In re Keller, 642 F. 2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F. 2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Yong S. Chong whose telephone number is (571)-272-8513. The examiner can normally be reached Monday to Friday: 9 AM to 5 PM EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam Milligan, can be reached at (571)-270-7674. The fax phone number for the organization where this application or proceeding is assigned is (571)-273-8300.
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/Yong S. Chong/Primary Examiner, Art Unit 1623
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