DETAILED ACTION
Status of Application
The instant application is being examined under the accelerated examination Track One program.
The amendments and response filed 08 December 2025 are acknowledged. Claims 1-10 and 13-14 are canceled and claims 15-25 are new. Claims 11-12 and 15-25 are pending.
Claims 20-25 are directed to subject matter commensurate with non-elected Group I (See restriction requirement, mailed 17 April 2025). Thus, said claims are withdrawn.
Claims 11-12 and 15-19 are subject to examination on the merits.
Claim Interpretation
The claims are amended to recite (claim 15; claim 11 is similar and is interpreted the same): A method comprising: adding a serine protease selectively degrading mucins and bromelain in a composition for preparing a drug for at least one of treating a mucus-related disease, or improving a therapeutic effect of the mucus-related disease and a quality of life of a patient with the mucus-related disease, wherein treating the mucus-related disease or improving the therapeutic effect of the mucus-related disease and the quality of life of the patient with the mucus-related disease comprises applying the composition containing the serine protease selectively degrading the mucins and the bromelain to the patient.
As noted in the previous Office action, the claims are interpreted as a method of making a pharmaceutical composition. The intended use of the composition, e.g. for treating various diseases and steps applied thereto do not limit the method of making. The claims are not considered methods of treatment and the steps in the claims reciting as such, again are simply intended use of said formulation after it has been made. As such, these steps in no way limit the method of making the pharmaceutical formulation.
Withdrawal of Previous Rejections
The rejection of claims 11-14 under 35 U.S.C. 101 because the claimed invention is directed to nonstatutory subject matter is withdrawn in view of the amendments to make said claims method claims.
The rejection of claims of 11-14 under 35 U.S.C. 112(b) for recitation of a method without any positive delimiting steps is withdrawn in view of the amendments to claim 11.
The rejection of claims of 11-14 under 35 U.S.C. 112(b) for recitation of improper Markush groupings is withdrawn in view of the amendments to remove said secondary Markush groups from the claims.
The rejection of Claim(s) 11-14 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Fleckenstein, J.M. (WO 2016/115328 – cited on IDS). Fleckenstein et al. do not teach adding bromelain or any other type of cysteine protease (or any other kind of protease for that matter) to the EatA pharmaceutical formulation.
New Rejection(s) – Necessitated by Amendments
Claim Rejections - 35 USC § 112(b)
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.
Claims 11-12 and 15-19 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claims 11 and 15 recite “adding a serine protease selectively degrading mucins and bromelain in a composition for preparing a drug for at least one…..”
Given the claim construction, the claims can be interpreted in two ways, rendering them indefinite. The first interpretation is that the serine protease is added to a composition and that it has the function of degrading both mucins and bromelain. The second interpretation is that both a serine protease and a bromelain are added to a composition together.
The dependent claims do not cure the noted deficiency and thus are included. Based upon Applicant’s comments in the response filed 08 December 2025 (directed to the 35 USC 102 rejection), the claims will be interpreted as requiring adding the serine protease and bromelain together to form a single composition.
The noted rejection can be overcome by modifying the claim to something like: A method for preparing a mucin degrading pharmaceutical composition comprising adding bromelain and a serine protease in a pharmaceutically acceptable formulation, wherein said serine protease selectively degrades mucins, and wherein said serine protease is serine protease EatA comprising a passenger domain having serine protease EatA activity, and said passenger domain is an amino acid sequence having at least 90% identity to SEQ ID NO: 2.
Conclusion
No claim is 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 SUZANNE M NOAKES whose telephone number is (571)272-2924. The examiner can normally be reached M-F (7-4).
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/SUZANNE M NOAKES/Primary Examiner, Art Unit 1656 22 May 2025
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