DETAILED ACTION
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 .
Priority
The instant application is a continuation of PCT/US22/12954, filed January 19, 2022, which claims priority to U.S. Provisional Application no. 63/139,732, filed January 20, 2021.
Information Disclosure Statement
3. The information disclosure statements (IDS) submitted July 19, 2023 and December 15, 2025 were in compliance with the provisions of 37 CFR 1.97 and 37 CFR 1.98. The IDS documents were considered. A signed copy of form 1449 is enclosed herewith.
Election/Restrictions
4. Applicant’s election without traverse of Group I in the reply filed on December 15, 2025 is acknowledged.
5. In accordance with the MPEP 803.02, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species, the search of the Markush-type claim will be extended (see MPEP 803.02). If prior art is then found that anticipates or renders obvious the non-elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be reexamined. Id. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. Id. In the event prior art is found during reexamination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final. Id.
6. As per MPEP 803.02, the Examiner will determine whether the entire scope of the claims is patentable. Applicants' elected species
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, wherein L1 and L1’ are -C(O)-, L2 is a covalent bond, L2’ is an optionally substituted bivalent saturated straight C1-C12 hydrocarbon chain, L3 and L3’ are a covalent bond, R1 is unsaturated straight C1-20 hydrocarbon chain, R1’ is L4-C(OA1)(OA2), L4 is C1-6 hydrocarbon chain, A1 and A2 are each C1-20 aliphatic, or X1 is O, X2 is C1-12 hydrocarbon chain, X3 is CyB, CyB is optionally substituted 3 to 7 membered saturated heterocyclyl having 1-3 heteroatoms independently selected from nitrogen, oxygen, and sulfur, makes a contribution over the prior art of record. Therefore, according to MPEP 803.02: should the elected species appear allowable, the search of the Markush-type claim will be extended. If art is found on a non-elected species, the Markush-type claim shall be rejected and claims to the nonelected invention held withdrawn from further consideration. Since art was found on a non-elected species, subject matter not embraced by the elected species is therefore withdrawn from further consideration. It has been determined that the entire scope claimed is not patentable.
Status of Claims
7. Claims 1-4, 6, 11, 13-14, 16-17, 19-21, 23-24, 26, 28, 31, 34-36, 44, and 55-56 are pending in the instant application. Claims 4, 17, 19, and 55-56 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a non-elected invention and species. Therefore, claims 1-3, 6, 13-14, 16, 20-21, 23-24, 26, 28, 31, 34-36, and 44 read on an elected invention and species and are therefore under consideration in the instant application.
Claim Objections
8. Claim 13 is objected to for depending on a rejected base claim.
9. Claim 34 is objected to for being written in improper Markush format. As written, the word "and" should be added between the second to last and last species of the Markush series. See MPEP 2173.05(h). “When materials recited in a claim are so related as to constitute a proper Markush group, they may be recited in the conventional manner, or alternatively. For example, if “wherein R is a material selected from the group consisting of A, B, C and D” is a proper limitation, then “wherein R is A, B, C or D” shall also be considered proper.”
10. Claim 36 is objected to for depending on an objected claim.
Claim Rejections - 35 USC § 102
11. 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.
12. 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.
13. Claims 1-3, 6, 14, 16, 20-21, 23-24, 26, 28, 31, 35, and 44 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CAplus Registry Number: RN 1452877-45-0. [Database Registry Chemical Abstracts Service, Columbus, Ohio, Accession No. RN 1452877-45-0, Entered STN: 20 Sep 2013].
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RN 1452877-45-0 anticipates the instant claims wherein L1 and L1’ are -C(O)-, in one scenario, L2 and L2’ are an optionally substituted bivalent saturated straight C1-C12 hydrocarbon chain, L3 and L3’ are a covalent bond, and R1 and R1’ are an optionally substituted group selected from saturated or unsaturated straight or branched C1-C20 hydrocarbon chain wherein 1 methylene unit is replaced by -O-; or in an alternative scenario L2 and L2’ are an optionally substituted bivalent saturated straight C1-C12 hydrocarbon chain, L3 and L3’ are -C(O)O-, and R1 and R1’ are substituted group selected from saturated straight C1 hydrocarbon chain; L2 and L2’ are a covalent bond, L3 and L3’ are a covalent bond, and R1 and R1’ are an optionally substituted group selected from saturated or unsaturated straight or branched C1-C20 hydrocarbon chain wherein 1 methylene unit is replaced by -O-; X1 is a covalent bond, X2 is an optionally substituted bivalent saturated or unsaturated straight or branched C1-C12 hydrocarbon wherein 1 methylene unit is replaced by -O-; X3 is CyB, CyB is 3 to 7 membered saturated heterocyclyl.
Registry number 1452877-45-0 is available as prior art as of 20 Sep 2013, the day it was indexed into the CAplus database.
See MPEP 2128: ELECTRONIC PUBLICATIONS AS PRIOR ART Status as a "Printed Publication" An electronic publication, including an on-line database or Internet publication, is considered to be a “printed publication” within the meaning of 35 U.S.C. 102(a) and (b) provided the publication was accessible to persons concerned with the art to which the document relates. See In re Wyer, 655 F.2d 221, 227, 210 USPQ 790, 795 (CCPA 1981) Since this date represents the date that each compound entered the CAPlus database on STN, this represents the date that each compound was made accessible to the public.
The aforementioned compounds anticipate the instantly claimed compounds: It is further noted that for the purposes of determining if a reference is a “printed publication” for the purposes of 102(b), MPEP 2128 states the following:
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where “prior art disclosures…on an on-line database are considered to be publicly available as of the date the item was publicly posted.” Since each of the database entries above lists the date that each compound was entered into the on-line database, the compounds were made publicly available as of that date in each citation, and the claims are anticipated.
Regarding the limitations of claims 35 “a lipid nanoparticle preparation comprising an ionizable lipid” – it is noted that this limitation merely recites properties of the anticipated compounds. “Products of an identical chemical composition cannot have mutually exclusive properties.” Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F. 2d 705, 709, 15 USPQd 1655, 1658 (Fed. Cir. 1990). Since the prior art teaches a product of identical chemical composition to that claimed, and the application discloses that all of the claimed compositions have the claimed properties, these limitations are also anticipated. Since the prior art teaches the identical chemical structure, the properties applicant claims are necessarily present. In re Spada, 911 F. 2d 705, 709, 15 USPQd 1655, 1658 (Fed. Cir. 1990). Since the prior art teaches a product of identical chemical compound to that claimed, and the application discloses that all of the claimed compounds have the claimed properties and no additional components are claimed, these limitations are also anticipated. The claimed compounds teach drug and no additional components. Therefore, the claims are anticipated by the aforementioned compound capable of being used with the claimed intended uses, as described herein.
MPEP 2111.02(II) provides the following instruction for interpreting the preamble of a claim: “During examination, statements in the preamble reciting the purpose or intended use of the claimed invention must be evaluated to determine whether the recited purpose or intended use results in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art. If so, the recitation serves to limit the claim.” If a prior art structure is capable of performing the intended use as recited in the preamble, then it meets the claim. See, e.g., In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed. Cir. 1997). Since the compounds taught by the prior art do not have any structural difference from the claimed preparation and the prior art compound are capable of the intended uses, those limitations are also anticipated, as discussed herein.
14. Claims 1-3, 6, 16, 20-21, 23-24, 26, 35, and 44 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CAplus Registry Number: RN 97056-39-8. [Database Registry Chemical Abstracts Service, Columbus, Ohio, Accession No. RN 97056-39-8, Entered STN: 06 Jul 1985].
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RN 97056-39-8 anticipates the instant claims wherein L1 and L1’ are -C(O)-, L2 and L2’ are a covalent bond, L3 and L3’ are a covalent bond, and R1 and R1’ are substituted phenyl; X1 is a covalent bond, X2 is a covalent bond, X3 is CyB, CyB is phenyl.
Registry number 97056-39-8 is available as prior art as of 06 Jul 1985, the day it was indexed into the CAplus database.
Regarding the compositions of claim 44, comprising the anticipatory compounds and an excipient, the Registry entry for Registry no. 97056-39-8 discloses a mass solubility of 0.00063 g/L, in unbuffered water at pH 6.58. This teaching of water anticipates the claimed composition, wherein the compounds are present with an excipient (i.e., water).
See MPEP 2128: ELECTRONIC PUBLICATIONS AS PRIOR ART Status as a "Printed Publication" An electronic publication, including an on-line database or Internet publication, is considered to be a “printed publication” within the meaning of 35 U.S.C. 102(a) and (b) provided the publication was accessible to persons concerned with the art to which the document relates. See In re Wyer, 655 F.2d 221, 227, 210 USPQ 790, 795 (CCPA 1981) Since this date represents the date that each compound entered the CAPlus database on STN, this represents the date that each compound was made accessible to the public.
The aforementioned compounds anticipate the instantly claimed compounds: It is further noted that for the purposes of determining if a reference is a “printed publication” for the purposes of 102(b), MPEP 2128 states the following:
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where “prior art disclosures…on an on-line database are considered to be publicly available as of the date the item was publicly posted.” Since each of the database entries above lists the date that each compound was entered into the on-line database, the compounds were made publicly available as of that date in each citation, and the claims are anticipated.
Regarding the limitations of claims 35 “a lipid nanoparticle preparation comprising an ionizable lipid” – it is noted that this limitation merely recites properties of the anticipated compounds. “Products of an identical chemical composition cannot have mutually exclusive properties.” Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F. 2d 705, 709, 15 USPQd 1655, 1658 (Fed. Cir. 1990). Since the prior art teaches a product of identical chemical composition to that claimed, and the application discloses that all of the claimed compositions have the claimed properties, these limitations are also anticipated. Since the prior art teaches the identical chemical structure, the properties applicant claims are necessarily present. In re Spada, 911 F. 2d 705, 709, 15 USPQd 1655, 1658 (Fed. Cir. 1990). Since the prior art teaches a product of identical chemical compound to that claimed, and the application discloses that all of the claimed compounds have the claimed properties and no additional components are claimed, these limitations are also anticipated. The claimed compounds teach drug and no additional components. Therefore, the claims are anticipated by the aforementioned compound capable of being used with the claimed intended uses, as described herein.
MPEP 2111.02(II) provides the following instruction for interpreting the preamble of a claim: “During examination, statements in the preamble reciting the purpose or intended use of the claimed invention must be evaluated to determine whether the recited purpose or intended use results in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art. If so, the recitation serves to limit the claim.” If a prior art structure is capable of performing the intended use as recited in the preamble, then it meets the claim. See, e.g., In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed. Cir. 1997). Since the compounds taught by the prior art do not have any structural difference from the claimed preparation and the prior art compound are capable of the intended uses, those limitations are also anticipated, as discussed herein.
Conclusion
15. No claims are allowed.
16. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Samantha Shterengarts whose telephone number is (571)270-5316. The examiner can normally be reached on Monday thru Thursday 9-6pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mr. Adam Milligan can be reached on 571-270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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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.
/SAMANTHA L SHTERENGARTS/Primary Examiner, Art Unit 1623