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 .
This application is the national stage entry of PCT/EP22/79343, filed 21 Oct 2022; and claims benefit of foreign priority document EP 21382960.9, filed 22 Oct 2021; claims benefit of foreign priority document EP 22382516.7, filed 30 May 2022; claims benefit of foreign priority document EP 22382897.1, filed 29 Sep 2022. These foreign priority documents are in English.
Claims 1-2, 5, 7, 9, 12-18, 20-21, and 23-27 are pending in the current application and are examined on the merits herein.
Claim Objections
Claim 20 is objected to because of the following informalities: claim 20 recites “wherein the RNA is a modRNA, saRNA, taRNA, or uRNA”. As these abbreviations are not well-known in the art, their meaning should be provided at the first appearance in the claims. For example, the published application at paragraph 292 defines each of these abbreviations.
Claim 21 is objected to because of the following informalities: claim 21 recites “a ratio of N/P”. As this abbreviation is not well-known in the art, its meaning should be provided at the first appearance in the claims. For example, the published application at paragraph 271 defines the ratio of cationic groups to anionic groups, which is referred to as an “N/P ratio”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 1-2, 5, 7, 9, 14-18, 20-21, and 23-27 are 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 1 recites the groups Z1 and Z2 “are each independently a cationic or ionizable group selected from…” The specification at page 46, line 30 states “As used herein, an “ionizable” moiety is a group that may have a neutral charge at a certain pH, but may become charged (e.g., cationic) at a different pH.” This definition using the terms “may” does not clearly redefine the term, and the ordinary definition of an “ionizable” group is a group which is capable of forming an ion, such as resulting from electron beam ionization in a mass spectrometer. See MPEP 2173.05(a) providing “Consistent with the well-established axiom in patent law that a patentee or applicant is free to be his or her own lexicographer, a patentee or applicant may use terms in a manner contrary to or inconsistent with one or more of their ordinary meanings if the written description clearly redefines the terms. See, e.g., Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999)” In this case the written description does not clearly redefine the term from its ordinary meanings. In contrast, claims 12-13 recite the groups Z1 and Z2 which are clearly cationic groups.
Claim 17 recites “The compound of claim 1, wherein the oligosaccharide is selected from Table 1.” MPEP 2173.05(s) provides “Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table “is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience.” Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (citations omitted).” In this case, it is possible to recite the specific chemical structures in the claim in order to be complete in itself, and incorporation-by-reference of the table is not a necessity.
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 1-2, 5, 7, 9, 12-18, 20-21, and 23-27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 5, 7, 10, 14-15, 17, 23-25, 27-28, and 30-34 of copending Application No. 18/702,855 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the Reference claims of the reference application recite embodiments of the compound which are identical to the claimed compound. In specific embodiments, Reference claim 24 recites the compound is selected from Reference Table 1 which includes the embodiments of JLF512, JLF 513, and JLF515, which are identical to the compounds of Table 1 as claimed in examined claim 24.
Further, Reference claim 1 recites a compound of formula I, wherein X1 and X2 are selected from -S-, -S-S-, and -NH-, where the remainder of the defined variables are the same as the claimed formula I, and the alternative of -S-S- corresponding to the compound of formula I of the examined claims. Reference claim 17 reciting formula Id-x and Reference claim 24 incorporating-by-reference the table which includes the embodiments of JLF512, JLF 513, JLF 514, and JLF515 provide guidance for selecting the compound where X1 and X2 are each -S-S-. Reference claims recite the same further limitations as the examined claims as follows:
Reference claim
Examined claim
2
2
5
5
7
7
10
9
14
12
15
13
23
16
25
18
27 (modRNA or saRNA)
20 (modRNA, saRNA, taRNA, or uRNA)
28
21
30
23
31
24
32
25
33
26
34
27
Regarding examined claim 15, reference claim 10 and the formulas of Reference claim 17 provide guidance for varying the structure of the group -NRyC(S)NRy-, making obvious selection of the structure corresponding to formula Id-i from within the scope of Reference formula 1.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The application under examination is deemed to have the same patent term filing date (21 Oct 2022) as the reference application. See MPEP 804 especially at I.B.1.(b).
Claims 1-2, 5, 7, 9, 12-18, 20-21, and 23-27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4, 7, 10-11, 14, 17-18, 21, 23, 28,30, 50, 53-54, 57, 62, 66-67, and 69-75 of copending Application No. 18/702,858 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the Reference claims of the reference application recite embodiments of a cationic oligosaccharide which are identical to the claimed compound. In specific embodiments, Reference claim 70 recites the compound is selected from Reference Table 1 or 2 which includes the embodiments of JLF 513, JLF515, PRX104, PRX106, PRX108, PRX109, ssJRL9, ssJRL13, and ssJRL102, which are identical to the compounds of Table 1 as claimed in examined claim 24. Regarding examined claim 15, Reference claim 70 incorporates compounds such as JLF621 and 622-642 which meet the structural limitations of the claimed formula.
Further, Reference claim 1 recites complex comprising a cationic oligosaccharide, a surfactant, and one or more additives. Reference claim 53 recite the cationic oligosaccharide is a compound of formula I, wherein X1 and X2 are selected from -S-, -S-S-, and -NH-, where the remainder of the defined variables are the same as the claimed formula I, and the alternative of -S-S- corresponding to the compound of formula I of the examined claims. Reference claim 70 incorporating-by-reference the Table 1 which includes the embodiments of detailed above provides guidance for selecting the compound where X1 and X2 are each -S-S-. Reference claims recite the further limitations that correspond to the examined claims as follows:
Reference claim
Examined claim
54
2
57
5
62
7
67
13
69
16
7
18
10
20
11
21
14
23
72
24
74
26
75
27
Regarding examined claim 12, the embodiments of Reference claim 70 and 67 provide guidance for selecting the groups Z1 and Z2 to be as claimed.
Regarding examined claim 25, Reference claim recites the target selected from a group including the liver, lungs, and the spleen, providing guidance for selecting these targets.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The application under examination is deemed to have the same patent term filing date (21 Oct 2022) as the reference application. See MPEP 804 especially at I.B.1.(b).
Relevant Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: KR’461 (KR 2013-0100461 A, published 11 Sep 2013, provided by Applicant in IDS filed 05 Nov 2024, EPO English machine translation cited in PTO-892).
KR’461 teaches novel compounds and their use as dispersants in the field of electrowetting display devices (EPO translation, page 2, 4th paragraph). KR’461 teaches disaccharide compounds such as
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268
318
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(page 12, paragraph 25; page 13, paragraph 29) and
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394
414
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(page 16, paragraph 49; page 17, paragraph 55).
Conclusion
No claim is currently in condition for allowance.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan S Lau whose telephone number is (571)270-3531. The examiner can normally be reached Monday-Friday 9a-5p Eastern.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Scarlett Goon can be reached at (571)270-5241. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JONATHAN S LAU/ Primary Examiner, Art Unit 1693
Prosecution Insights