DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This is the third Office action on the merits of the claims.
All citations to the Manual of Patent Examining Procedure (MPEP) refer to Revision 01.2024, which was released in November 2024.
Continued Examination
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after allowance or after an Office action under Ex Parte Quayle, 25 USPQ 74, 453 O.G. 213 (Comm’r Pat. 1935). Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant’s submission filed on 02 June 2026 has been entered.
Status of the Claims
Claims 34-58 are pending.
Claim Rejections - 35 U.S.C. 112(b)
The following is a quotation of 35 U.S.C. 112(b):
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.
Claims 55-58 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter that the inventors regard as the invention.
Regarding claims 55-58, the phrase “per dose” is unclear. First, there is no antecedent basis for “dose.” See MPEP § 2173.05(e) (lack of antecedent basis). The examiner notes that the administered formulation is not defined as a unit dosage form. Second, how does one differentiate between successive doses? For example, what is the requisite time interval between them? In other words, where does one dose end and another begin? The examiner recommends amending claims 55-58 by deleting “per dose” and adding a temporal limitation. Conventionally, claims directed to methods of treatment that contain dosing regimens are expressed in units such as “µg/kg/day” (for claims 55-57) and “µg/day” (for claim 58). The temporal limitation assists in establishing that the administered amounts actually are effective in treating the disease.
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Conclusion
Claims 34-54 are allowed.
Claims 55-58 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PETER ANTHOPOLOS whose telephone number is 571-270-5989. The examiner can normally be reached on Monday – Friday (9:00 am – 5:00 pm). If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany P. Barham, can be reached on Monday – Friday (9:00 am – 5:00 pm) at 571-272-6175. The fax number for the organization where this application or proceeding is assigned is 571-273-8300.
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/P.A./
12 June 2026
/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
Prosecution Insights