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 .
Notice of Pre-AIA or AIA Status
DETAILED ACTION
Status of the Claims
Claims 2-4, 7, 9, 13, 15-18, 20-21, 23, and 31-34 are cancelled. Claims 1, 5-6, 8, 10-12, 14, 19, 22, and 24-30 are pending and under examination.
Priority
This application is a national stage entry of PCT/CA2022/051889 filed on 12/22/2022, which claims priority from Canadian application CA3143650 filed on 12/22/2021.
Information Disclosure Statement
The information disclosure statements filed on 10/15/2024 and 12/29/2025 have been considered by the examiner.
Objection to the Specification
Table 1 in applicant’s specification is objected to because there appear to be disconnected or incomplete bonds in some of the compounds listed in the table such as compounds 100-102, and 104-111. Appropriate correction is required.
Claim Objections
Claim 25 is objected to as it needs to include “further” before “comprising” in the claim since it is further adding to what was introduced to the nanoparticle in claim 24.
Claim 28 is objected to for recitations of “including” and multiple recitations of “or” through the group and ending with “and/or….”. The group only needs one “or” between the last two items of the group (….Shiga toxin, or Shiga-like toxin.) to indicate that the items are alternatives.
Appropriate correction is required.
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 22 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 22 is indefinite for referring to the compounds of table 1 where the compounds in table 1 are either not formatted correctly or incomplete, and have question marks at various positions. This makes it unclear how the compounds should be considered or in some cases what the compounds are. Applicant should denote the correct compounds structures as options in the claim.
Claim Rejections - 35 USC § 102
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.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Budani et al (Journal of Lipid Research, 2016, volume 57, pages 1728-1736).
“Optionally substituted” allows for various groups attached to the mentioned group.
Budani teaches
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269
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(figure 1).
Claim(s) 1, 5, 6, 10, 24-27, and 29-30 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Koker WO2022136641A1 (effective filing date of December 23, 2020).
Koker teaches an ionizable cationic lipid that is used for preparation of nanoparticle compositions comprising nucleic acids and allows for vaccine formulations with the nanoparticles (abstract). Koker teaches a compound on page 2-
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Koker teaches compounds on page 5 that have disulfide groups with C2 alkylene groups that attach to ester groups where one side has groups alkylene groups with C16 or C17 or other carbon numbers and where the other side can have either an H or two alkyls or other groups. As the claims allow for optional substitutions, the groups in the claims that have optional substituents are allowed to have other groups. The compounds found on page 5 are:
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.
Compounds having a disulfide group with alkyl chains rather than alkylene chains are found on page 7 (first six listed compounds). Page 9 of Koker provides these compounds -
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. Additional compounds with the disulfide groups, fatty chains (R1 and R2), and groups that can serve as X1, X2, Y1, Y2 , Z , R3 and R4 as in applicant’s compounds are found on page 48-49 as well as pages 33-38 of Koker. Koker teaches “This also means that R1 and R2 do not need to be identical, while in a specific embodiment, they may be identical to each other.” Koker teaches mRNA, DNA and cDNA (end of page 42 and top of page 43). Koker teaches antigens, proteins or peptides (page 44). Koker teaches using the vaccine to induce immune responses by administration of the vaccines (page 44). Koker teaches for treating a disease such as cancer and also for prophylaxis of infections (page 44). The top of page 45 provides for both treating cancers and infectious diseases. Koker teaches cancer cell lines “CT26-B16F10-TS/A” (top of page 70), where CT26 is a colorectal cancer model, B16F10 is a melanoma model and TS/A is a mammary adenocarcinoma model.
Claim Rejections - 35 USC § 103
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 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.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 11, 12, 14, 19, and 22 in addition to claims 1, 5, 6, 10, 24-27, and 29-30 are rejected under 35 U.S.C. 103 as being unpatentable over Koker WO2022136641A1 (effective filing date of December 23, 2020) and CMC (Cambridge MedChem Consulting, Bioisosteric Replacements, January 30, 2021, https://www.cambridgemedchemconsulting.com/resources/bioisoteres/).
Koker teaches the claims as discussed above.
The main difference between Koker and applicant’s claims is the nitrogen group on the portion of the compound that attaches to the long chain alkyl, alkylene, or alkylyne groups of R1 and R2.
CMC teaches a bioisostere is a molecule resulting from the exchange of an atom or of a group of atoms with an alternative, broadly similar, atom or group of atoms. CMC teaches the objective of bioisostearic replacement is to create a new molecule with similar biological properties to the parent. CMC teaches simple replacements where CH2, NH, O and S are recognized as being atoms that may replace each other.
One of ordinary skill in the art before the time of filing would have been able to alter a nitrogen in the compound of Koker to a carbon with the expectation of obtaining a biostere with similar function by teachings of CMC. Koker recognizes the same use/function for its cationic lipids as applicant does for compounds of their claims regarding nanoparticles for vaccines. There was a reasonable expectation of success in using Koker and CMC’s teachings to provide for other biosteres that will serve in making lipid nanoparticles for carrying vaccines to administer to subjects for treating or preventing infectious diseases or cancer.
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Koker WO2022136641A1 (effective filing date of December 23, 2020) and Thomas WO2021000041A1 (published January 2021).
Koker teaches the claims as discussed above.
Koker does not teach the infectious diseases of claim 28.
Thomas teaches ionizable lipids for nucleic acid delivery (abstract). Thomas teaches immune response against pathogens such as bacterium, virus, fungi or parasite (paragraph 214). Thomas teaches viruses such as coronavirus, hepatitis virus, herpes, or others (paragraphs 215-216). Thomas teaches cancers in paragraph 221 including melanoma and others. Example 21 teaches lipid nucleic acid nanoparticle.
One of ordinary skill in the art before the time of filing would have utilized Koker’s nanoparticle system with various nucleic acids to vaccinate or treat a variety of infectious diseases and cancers provided by the prior art (Thomas). There would be a reasonable expectation of success in combining the teachings of Koker and Thomas and successfully treating the infectious diseases treatable with ionizable lipid carried nucleic acids to provide vaccination.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 5-6, 8, 10-12, 14, 19, 22, and 24-30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, 6, 8, 10-12, 14, 19, 22, 49, 56-59, and 63 of copending Application No. 19/495,136 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because each claim set provides for ionizable lipid compounds of similar formula, forms of nanoparticles and vaccines as well as methods of treating infectious diseases or cancers.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARK V STEVENS whose telephone number is (571)270-7080. The examiner can normally be reached M-F 9:00 am to 6:00 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian-Yong Kwon can be reached at (571)272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARK V STEVENS/Primary Examiner, Art Unit 1613