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 December 16, 2025.
This office action supersedes the office action mailed on 02/02/2026.
Status of Claims
Cancellation of claim 16 and addition of claim 17 is acknowledged
Claim 17 is presently under examination.
Priority
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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.
Claim 17 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 17 requires “avoiding” concomitant administration of famotidine and dichlorphenamide. However, the claim recites: “the subject is “also” being administered famotidine…”. The word “also” implies that something else (besides famotidine) is being administered to the subject, and since the subject suffers from primary hyperkalemic periodic paralysis or primary hypokalemic periodic paralysis, it seems like the subject is “also” being administered dichlorphenamide (in order to treat primary hyperkalemic periodic paralysis or primary hypokalemic periodic paralysis), which contradicts “avoiding” concomitant administration of famotidine and dichlorphenamide.
The metes and bounds of the claim are not clearly defined.
For prior art search, it is going to be assumed that the subjects are first being administered famotidine (without the administration of dichlorphenamide), then famotidine is discontinued and then dichlorphenamide is being administered (without the administration of famotidine),
Claim Rejections - 35 USC § 103.
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
CLAIM INTERPRETATION: for claim 17 it is going to be assumed that the patients suffer from primary hyperkalemic periodic paralysis and peptic ulcer disease (PUD) and that are being administered famotidine to treat PUD. The administration of famotidine is then discontinued, and after that, dichlorphenamide is being administered to treat primary hyperkalemic periodic paralysis (see 112(b) rejection above).
Claim 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over KEYEVIS™ Prescribing Information (August 2015, cited in prior office action) and PEPCID ® Prescribing Information (June 2011, cited in prior office action) in view of Tarsio et. al. (US 2019/0169593) and in view by Bhat et. al. (Indian Journal of Pharmaceutical Sciences (2005) 67:151-159).
For claim 17, the PEPCID ® Prescribing Information teaches a method of treating peptic ulcer disease (PUD, see page 7) comprising the administration of famotidine, which is a histamine H2-receptor antagonist (see description). Further, the PEPCID ® Prescribing Information teaches that in some patients suffering renal insufficiency the dose of famotidine may be reduced to half a dose, or the dosing interval may be prolonged to 36-48 hours as indicated by the patient’s clinical response (see page 10). The PEPCID ® Prescribing Information teaches a series of adverse reactions caused by the administration of famotidine (see page 8 under Adverse Reactions). It states: “in a clinical study in 35 pediatric patients, agitation was observed in 5 patients on famotidine that resolved when the medication was discontinued” (see page 8 before OVERDOSAGE). Also, patients should be monitored for over dosage (see pages 8-9 under OVERDOSAGE). Also, patients with renal insufficiency should be monitored and the dose reduced accordingly (see page 10).
The PEPCID ® Prescribing Information does not teach the treatment of primary hyperkalemic periodic paralysis comprising the administration of a therapeutically effective amount of dichlorphenamide to subjects in need thereof. However, the KEYEVIS™ prescribing information, teaches a method of treating primary hyperkalemic periodic paralysis comprising the administration of a therapeutically effective amount of dichlorphenamide, which is a carbonic anhydrase inhibitor, to subjects in need thereof (see under Indications and Usage), wherein the dosage consists of 50 mg twice daily (see under Dosage and Administration). Further, the KEYEVIS™ prescribing information teaches that one of the contraindications is: hypersensitivity to dichlorphenamide or other sulfonamides (see section 4. contraindications). Hypersensitivity to sulfonamides can cause fatalities due to adverse reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia and other blood dyscrasias (see section 5.1).
Baht teaches what is well known in the prior art: that both: dichlorphenamide and famotidine are known sulfonamides (see abstract):
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DICHLORPHENAMIDE
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FAMOTIDINE
Finally, Tarsio teaches that histamine H2 receptor antagonists (like famotidine) and carbonic anhydrase inhibitors (like dichlorphenamide) induce nephrotoxicity (see [0475]).
Before the effective filing date, it would have been prima facie obvious for the skilled in the art to administer to a subject suffering from both: primary hyperkalemic periodic paralysis and PUD, a composition comprising a therapeutically effective amount of famotidine (for the treatment of PUD) and a composition comprising dichlorphenamide (for the treatment of primary hyperkalemic periodic paralysis).
It will be further obvious to administer both drugs in any order: famotidine before dichlorphenamide or dichlorphenamide before famotidine or both drugs at the same time since dosage optimization is routine practice in the pharmaceutical art.
However, the skilled in the art will be motivated to avoid co-administering both drugs, since both drugs are sulfonamides (and the KEYEVIS™ prescribing information teaches that hypersensitivity to sulfonamides is a contraindication) and since, according to Tarsio, both drugs can increase the chance of a patient suffering from nephrotoxicity.
All this will result in the practice of claim 17 with a reasonable expectation of success.
Conclusion
No claims are allowed.
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.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L. Clark can be reached on 571 272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARCOS L SZNAIDMAN/
Primary Examiner, Art Unit 1628
February 23, 2026.
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