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
This office action is in response to Applicant’s reply filed on November 4, 2021.
Status of Claims
Cancellation of claims 1-15 and addition of claim 16 is acknowledged.
Claim 16 is currently pending and are the subject of this office action.
Claim 15 is presently under examination.
Priority
PNG
media_image1.png
91
288
media_image1.png
Greyscale
Rejections and/or Objections and Response to Arguments
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated (Maintained Rejections and/or Objections) or newly applied (New Rejections and/or Objections, Necessitated by Amendment or New Rejections and/or Objections not Necessitated by Amendment). They constitute the complete set presently being applied to the instant application.
Responses to Applicant’s arguments have been addressed immediately after the corresponding rejections, or in the section: Withdrawn Rejections and/or Objections, if the rejection was withdrawn.
Claim Rejections - 35 USC § 102 (New Rejection Necessitated by Amendment).
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.
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.
Claim(s) 16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sansone et. al. (Neurology (2016) 86:1408-1416) as evidenced by Clinicaltrials.gov NCT00494507 (2017).
For claim 16, Sansone teaches a method of treating hyperkalemic periodic paralysis (HYP) or hypokalemic periodic paralysis (HOP) comprising administering to a subject in need thereof a composition comprising 50 mg of dichlorphenamide b.i.d. (twice a day) (see Abstract and page 1409 under Study design and Intervention). This study is listed on clinical trals.gov (NCT00494507 (2017)) which teaches that dichlorphenamide was administered as a tablet.
The prior art does not explicitly teach: ”while avoiding concomitant administration to said human patient of an organic anion transporter-1 (OAT-1) substrate, wherein the OAT1 substrate is famotidine”. However, the prior art does not mention the administration of famotidine. As such, since there was no famotidine being administered during the administration of dichlorphenamide, the concomitant administration of dichlorphenamide and famotidine was essentially “avoided.”
Double Patenting (New Rejection Necessitated by Amendment).
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.
Claim 16 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 24-27 of copending Application No. 16/780,057 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both applications recite methods of treating hyperkalemic periodic paralysis (HYP) or hypokalemic periodic paralysis (HOP) comprising administering to a subject in need thereof a composition comprising dichlorphenamide.
The administration of dichlorphenamide is discontinued before starting the administration of famotidine, as such the concomitant administration of dichlorphenamide and famotidine is avoided.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 16 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 28 of copending Application No. 17/108,675 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both applications recite methods of treating hyperkalemic periodic paralysis (HYP) or hypokalemic periodic paralysis (HOP) comprising administering to a subject in need thereof a composition comprising dichlorphenamide.
The prior art does not explicitly teach: ”while avoiding concomitant administration to said human patient of an organic anion transporter-1 (OAT-1) substrate, wherein the OAT1 substrate is famotidine”. However, the prior art does not mention the administration of famotidine. As such, since there was no famotidine being administered during the administration of dichlorphenamide, the concomitant administration of dichlorphenamide and famotidine was essentially “avoided.”
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Similarly, the following co-pending applications are subject to double patenting rejection:
15/540,468; 16/540,450; 16/540,447; 17/216,080; 16/201,410; 16/535,704; 17/108,675; 16/253,515 and 17/123,730.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 date of this final action.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARCOS L SZNAIDMAN whose telephone number is (571)270-3498. The examiner can normally be reached on Flexing M-F 7 AM-7 PM.
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, Winston Shen can be reached on 2-3157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MARCOS L SZNAIDMAN/
Primary Examiner, Art Unit 1628
November 11, 2021.