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 .
Response to Election/Restriction filed on July 14, 2025 is acknowledged.
Claims 16-33 are pending in this application.
Restriction
Applicant's election with traverse of Group 1 (claims 16-21) and antibiotic-resistant staphylococcus aureus as the species of a bacterial infection, Staphylococcus aureus skin infection as the species of type of bacterial infection in the reply filed on July 14, 2025 is acknowledged. The traversal is on the ground(s) that there is no burden on the Office. This is not found persuasive because instant application is a 371 of a PCT application. Burden is not involved in a 371 application. Applicant’s arguments are moot. Further, small molecules and peptides have different core structure that are not shared by each invention. Additionally, lack of unity of invention was established in the previous office action.
The requirement is still deemed proper and is therefore made FINAL. Claims 22-33 are withdrawn from consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions, there being no allowable generic or linking claims. Claims 16-21 are examined on the merits in this office action.
Objections
5. The abstract is objected to for the following minor informality:
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words. It is important that the abstract not exceed 150 words in length since the space provided for the abstract on the computer tape used by the printer is limited. The form and legal phraseology often used in patent claims, such as "means" and "said," should be avoided. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, "The disclosure concerns," "The disclosure defined by this invention," "The disclosure describes," etc.
In the instant case, the abstract recites, “The present invention relates to the field of caspase inhibition...” at line 1 of the abstract. Further, at line 2, the abstract recites, "More specifically, the present invention provides..." Furthermore, at lines 5-8, the abstract recites, "In a specific embodiment...to the patient an effective amount of a caspase inhibitor" appear to be an incomplete sentence. Applicant should correct these informalities. See MPEP 608.01(b). For example, the line 1 of the abstract is suggested to be amended to recite, “Caspase inhibition is described.”
Please note, the specification has not been checked to the extent necessary to determine the presence of all possible error. Applicant's cooperation is required in correcting any errors of which applicant may become aware in the specification. MPEP § 608.01.
Rejections
U.S.C. 102
6. 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 (i.e., changing from AIA to pre-AIA ) 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.
7. 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.
8. Claim(s) 16-21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shi reference (WO 2018/195727, filed with IDS).
9. Shi reference teaches a use of a TNFR1-FADD-caspase8-caspase3 pathway inhibitor in preparation of a medicament for treating an immune system related disease caused by autoinducer (see claim 1), wherein the immune system related disease is Pseudomonas aeruginosa infection related disease (see claim 3), wherein the TNFR1-FADD-caspase8-caspase3 pathway inhibitor is at least one selected from a group consisting of a TNFR1 inhibitor, a TNFR1 trimerization inhibitor, a FADD inhibitor, a caspase inhibitor (see claim 4), wherein the caspase inhibitor comprises at least one selected from…Emricasan (see claim 9), a method of treating an immune system related disease caused by autoinducer comprising administering a TNFR1-FADD-caspase8-caspase3 inhibitor to a subject in need thereof (see claim 15), wherein the immune system related disease is Pseudomonas aeruginosa infection-related disease (see claim 17), wherein the TNFR1-FADD-caspase8-caspase3 pathway inhibitor is at least one selected from a group consisting of a TNFR1 inhibitor…a caspase inhibitor (see claim 18), and wherein the caspase inhibitor comprises at least one selected from …Emricasan (see claim 23). With respect to the limitation in the preamble of claims 16-21, “A method for treating a bacterial infection in a patient, comprising..”, please note that MPEP 2111.02 II states "a preamble generally is not limiting when the claim body describes a structurally complete invention such that deletion of the preamble phrase does not affect the structure or steps of the claimed invention." In the instant case, the preamble does not affect the method steps. The preamble in this case recites a statement of purpose or use, and therefore was not treated as a claim limitation. Therefore, anybody being administered emricasan would have the same end effect/result of “treating a bacterial infection”. Because the reference teaches ALL of the active method steps, i.e., the same patient population and the same compound, the reference anticipates instant claims 16-21.
CONCLUSION
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JULIE HA whose telephone number is (571)272-5982. The examiner can normally be reached Monday-Thursday 5:00 am- 6:30 pm EST.
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/JULIE HA/Primary Examiner, Art Unit 1654
10/19/2025