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 .
Status of the Claims and Response to Amendments
The amendments filed on March 24, 2026 have been acknowledged and entered. Claims 1, 6, 7, and 9-18 are pending. Claims 2-5 and 8 are cancelled.
Withdrawn Rejections
Applicant is notified that any outstanding rejection or objection that is not expressly maintained in this office action has been withdrawn or rendered moot in view of applicant’s amendments and/or remarks.
Status of Priority
The present application is a 35 U.S.C. § 371 national stage patent application of International patent application PCT/NL2021/050351, filed on June 02, 2021. This application also claims the benefits of foreign priority to NL2025730, filed on June 02, 2020.
Specification - Disclosure
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections – Informalities
Claim 1 is objected because of the following informalities:
For clarity and to avoid 112(a) issues:
“R2 and R3 together with the N atom to which they are attached form a saturated ring incorporating an additional N atom…” should read“R2 and R3, together with the N atom to which they are attached, form a 5-8 membered saturated ring incorporating an additional N atom…”
For clarity,
“… wherein the compound according to formula (I) as free base has a molecular weight lower than 400 Da” should read“… wherein the compound according to formula (I), as a free base, has a molecular weight lower than 400 Da”
Appropriate correction is required.
Claim Objections – Substantial Duplicate
Claim 17 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 1.
Claim 17 is ultimately dependent on claim 1. Claim 1 is directed to a method for treatment or prophylaxis of sepsis, the method comprising administering to a subject a compound according to formula (I) wherein the compound according to formula (I), as a free base, has a molecular weight lower than 400 Da. Claim 17 also essentially claims the method according to claim 1, “wherein the compound according to formula (I) as defined in options (i) and (ii) has a molecular weight lower than 400 Da.” Thus, claim 17 is not further limiting the subject matter of claim 1 and is a substantial duplicate of claim 1.
When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
--------------- Rejections Necessitated by Applicant Amendment -----------------
Claim Rejections - 35 USC § 112(a) – Written description
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 1 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites:
“…wherein either:i) R2 and R3 together with the N atom to which they are attached form a saturated ring incorporating an additional N atom…
Claim 1 as currently written implies that the saturated ring can be of any size. However, the instant specification only provides written description support for R2 and R3 together with the N atom to which they are attached form a 5-8 membered saturated ring (see pg. 3, lines 10-12). Thus, claim 1 fails to comply with the written description requirement.
------------------------------ Added Rejections ---------------------------
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 12, 16, and 17 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claims 12 and 16 are dependent on claim 1 which states that the compound according to formula (I), as a free base, has a molecular weight lower than 400 Da. However, claims 12 and 16 recite molecular weight limitations of “lower than 500 Da” and “lower than 450 Da,” respectively. These limitations do not further restrict the subject matter of claim 1 and, instead, broaden its scope. Accordingly, claims 12 and 16 fail to further limit the subject matter of claim 1.
Claim 17 is ultimately dependent on claim 1. Claim 1 is directed to a method for treatment or prophylaxis of sepsis, the method comprising administering to a subject a compound according to formula (I) wherein the compound according to formula (I), as a free base, has a molecular weight lower than 400 Da. Claim 17 also essentially claims the method according to claim 1, “wherein the compound according to formula (I) as defined in options (i) and (ii) has a molecular weight lower than 400 Da.” Thus, claim 17 is not further limiting the subject matter of claim 1 and is, instead, a substantial duplicate of claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Allowable Subject Matter
Claims 6, 7, 9-11, 13-15, and 18 are objected to as being dependent upon a rejected base claim, but would be allowable once the rejected base claim is amended appropriately.
Conclusion
Claims 6, 7, 9-11, 13-15, and 18 are objected to. Claims 1, 12, 16, and 17 are rejected. Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISTEN ROMERO whose telephone number is (571)272-6478. The examiner can normally be reached M-F 9:30 AM - 6:00 PM ET.
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/KRISTEN W ROMERO/Examiner, Art Unit 1624
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624
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