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 is a response to Applicant’s communication filed on December 17, 2025. Application No. 18/016,625, is a 371 of PCT/EP21/70026, filed July 16, 2021, and claims foreign priority to European Patent application No. EP 20305825.0, filed July 17, 2020. In a preliminary amendment filed January 17, 2023, Applicant cancelled claims 3, 4, 6-8, 11-13, 20 and 21. Claims 1, 2, 5, 9, 10, 14-19, and 22-30 are pending.
Species Election
Applicant’s election without traverse of the compounds species of claim 17, in the reply filed on December 17, 2025, is acknowledged. Claim 15 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species. The election was made without traverse in the reply filed on December 17, 2025.
The elected species is allowable. The search has been expanded accordingly.
Claims 1, 2, 5, 9, 10, 14, 16-19, and 22-30 are pending.
Claim Rejections - 35 USC § 102(a)(1)
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.
Claim 1, 2, 5, 9, and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rongved et al., US2019/0284167 A1. The CAS Abstract for Rongved discloses the following lipidic compound:
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(Rongved et al., citing the CAS Abstract for the lipidic compound disclosed above.) This compound reads on a radical of formula (I), where in formula (I) A is a substituted 6-membered aromatic heteroaromatic ring radical; n is 0; X is O; and the radical is bonded to one C10-C55 lipophilic or hydrophobic tail-group.
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 1, 2, 5, 9, 10, 14-19, and 22-30 are rejected under 35 U.S.C. 112(b) as failing to set forth the subject matter which the inventor or a joint inventor regards as the invention. Where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999).
The term “* represents a single bond linking said radical of formula I), directly or not¸ to one C10- to C55 lipophilic or hydrophobic tail-group,” (emphasis added) is vague, ambiguous, and unconventional in the art. The scope of the on moiety attached to radical of formula (I) is unclear. The specification fails to provide any guidance. See Specification, p. 17, lns. 30-32. The term is indefinite because the specification does not clearly redefine the term.
Claim 5 recites the limitation "p is 0 or 1" in the Markush definition of formula (II). Formula (II) (nor formula (I) of claim 1) does not require “p”. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 112(a)
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.
Claim 30 is rejected under 35 U.S.C. 112(a) because the specification, while being enabling for a composition for use in a therapeutic method for treating a disease, the specification does not reasonably provide enablement for preventing any disease. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
Factors to be considered when determining whether claims in an application for patent are enabling include (1) the breadth of the claims, (2) the nature of the invention, (3) the state of the prior art, (4) the level of one of ordinary skill, (5) the level of predictability in the art, (6) the amount of direction provided by the inventor, (7) the existence of working examples, and (8) the quantity of experimentation needed to make or use the invention based on the content of the disclosure. See MPEP § 2164.08, citing In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
The claims include preventing diseases. The specification teaches that the lipidic compounds and compositions thereof maybe used as lipid nanoparticles for the delivery of therapeutic agents. (Specification, p. 1.) The specification provides no direction as to how preventing a disease might be accomplished. The prior art fails to provide compensatory guidance. There is no correlation in either the instant specification or the prior art, between the use of lipid nanoparticles to deliver known therapeutics, and the prevention of any disease. Accordingly, it would require undue experimentation for the artisan to practice the invention as broadly claimed.
Conclusion
No claims are allowed.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIMOTHY R ROZOF whose telephone number is (571)270-5992. The examiner can normally be reached on Monday - Friday, 9:00 a.m. -5:00 p.m..
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached on (571) 272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/TIMOTHY R ROZOF/
Primary Examiner, Art Unit 1625