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 .
Claim(s) 1-2,4,12-16,18,25-27, 29-30, 36-37, 39, 40, and 51-52 are pending.
Preliminary Amendment
Applicant’s preliminary amendment filed on 07/27/2023 is acknowledged. The specification was amended to add Cross-reference to related applications statement. The claim(s) were amended to (1) cancel 3, 5-11, 17, 19-24, 28, 31, 32, 34, 35, 38, and 43-50, and (2) amend 1, 4, 13, 16, 18, 26, 30, 33, 36, 37, 39, 41, and 42.
Applicant’s preliminary amendment filed on 02/09/2024 is acknowledged. The claim(s) were amended to (1) cancel 33, and (2) amend 15, 25, 26, 29, 30, 36, 37, and 40.
Applicant’s preliminary amendment filed on 03/26/2026 is acknowledged. The claim(s) were amended to (1) cancel 41 and 42, (2) amend 1, 18, and 29, and (3) add 51 and 52.
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 03/26/2026 is acknowledged.
Applicant’s election without traverse of the species of dsRNA duplex, AD-1444282.1 in the reply filed on 03/26/2026 is acknowledged. AD-1444282.1 comprises SEQ ID NO: 208 (unmodified antisense strand), SEQ ID NO: 171 (unmodified sense strand), SEQ ID NO: 97 (modified antisense strand), and SEQ ID NO: 60 (modified sense strand).
Claim(s) 29, 30, 36, 37, 39, and 40 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention of Group II, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03/26/2026.
Claim(s) 1-2, 4, 12-16, 18, 25-27, and 51-52 are under consideration.
Priority
This application is a 371 of PCT/US2022/014309. Acknowledgement is made of Applicant’s claim for priority based on a provisional application(s) filed as 63/143,608 on 01/29/2021 and 63/173,997 on 04/12/2021.
All claims are given the priority date of 01/29/2021.
Information Disclosure Statement
Receipt of the information disclosure statement(s) on 07/27/2023, 11/10/2023, 02/09/2024, and 03/26/2026 are acknowledged. The signed and initialed PTO-1449 form(s) has/have been mailed with this action.
The information disclosure statement filed 02/09/2024, fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed.
Of note: under OTHER DOCUMENTS, citation #424 (i.e., Walsh, et al, “The APP family of proteins: similarities and differences,” Biochem. Soc. Trans., 2007, 35(2): 416-420) is missing. There is a citation under Walsh et al, Minireview, Gene Therapy for Human Hemoglobinopathies, volume 204, pages 289-300, published 1993 that was not listed in the IDS filed 02/09/2024 but had nonetheless been submitted. This Walsh et al from 1993 has been considered and added under citation #424. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
See page 29, line 15;
The use of the term(s):
Sybr (page 41, line 16, 19);
Oligofectamine (page 124, line 30);
Lipofectamine (page 136, line 18);
Lipofectin (page 154, line 12);
PAXgene (page 161, line 25);
MerMade (page 171, line 28);
Sephadex (page 172, line 11);
Tecan (page 172, line 14);
Opti-MEM (page 172, line 26);
RNAiMax (page 172, line 27);
Dynabeads (page 173, line 1, 4; page 182, line 7);
Taqman (page 173, line 20, 23, 26); and
Lightcycler (page 173, line 21, 24, 30, 32),
which is/are a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claim 52 is objected to because of the following informalities: the claim does not end in a period. Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 25 is rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 25 does not explicitly recite “human organism”, however the instant specification discloses “In one embodiment, the cell is within a subject, optionally the subject is a human or the subject is selected from the group consisting of a rhesus monkey, a cynomolgous monkey, a mouse, and a rat”, (see page 21, lines 14-16). Therefore, claim 25 encompasses a human cell in a human (i.e., a human organism), which is excluded from the scope of patentable subject matter.
Limiting claim 25 to “an isolated cell” would obviate the rejection.
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(s) 27 and 52 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 27 recites, “The pharmaceutical composition of claim 26, wherein the double stranded RNAi agent is administered in an unbuffered solution, optionally saline or water, or said double stranded RNAi agent is administered with a buffer solution, optionally comprising acetate, citrate, prolamine, carbonate, phosphate, phosphate buffered solution (PBS), or any combination thereof.” Actions present within a product claim create confusion as to when direct infringement occurs. See MPEP 2173.05(p)(II). It would be remedial to amend claim 27 to recite, “wherein the pharmaceutical composition comprises an unbuffered solution, optionally saline or water, or a buffer solution, optionally comprising acetate, citrate, prolamine, carbonate, phosphate, phosphate buffered solution (PBS), or any combination thereof.”
Claim 52 depends from itself and recites the limitation "the double stranded ribonucleic acid (RNAi) agent of claim 52…" in line 1. There is insufficient antecedent basis for this limitation in the claim. It would be remedial to amend claim 52 to depend upon a claim that would remedy this insufficiency (i.e., claim 1 or claim 51).
Claim Rejections - 35 USC § 102
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(s) 1, 4, 12, 25, 26, and 51 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Roch et al (US 2004/0226056 A1; published November 11th, 2004).
Regarding claim(s) 1, 4, 12, and 51, Roch et al discloses five double-stranded RNAi agents targeting APP in Figure 59. More specifically, siRNA4’s bottom strand is identical to SEQ ID NO: 208 (per instant claim 1 and 51) and the top strand is identical to SEQ ID NO: 171 (per instant claim 51), see Figure 59 below. This bottom strand of siRNA4 also contains two dT modifications.
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Regarding claim 25, Roch et al discloses, “In another embodiment, double-stranded small interfering RNA (siRNA) compounds specific to nucleic acids encoding one or more interacting protein members of a protein complex identified in the present invention are administered to cells or tissue in vitro or in a patient to be therapeutically or prophylactically treated. FIGS. 1-59 depict the structures of siRNA compounds designed to reduce the expression of specific proteins that comprise the protein complexes of the present invention.”, (see paragraph [0401]).
Regarding claim 26, Roch et al discloses, “Liposomes can also be used as carriers for the active compounds of the present invention. Liposomes are micelles made of various lipids such as cholesterol, phospholipids, fatty acids, and derivatives thereof.”, (see paragraph [0567]).
Thus, claim(s) 1, 4, 12, 25, 26 and 51 are anticipated by Roch et al.
Claim(s) 1, 4, 12, 25-27, and 51 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McSwiggen et al (WO 2005/003350 A2; published January 13th, 2005).
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Regarding claim(s) 1 and 51, McSwiggen et al discloses dsRNA for targeting APP. More specifically, in Table II on page 156, McSwiggen et al discloses a sense nucleic acid strand, SEQ ID NO: 82, which is identical to instant SEQ ID NO: 171, and SEQ ID NO: 281, which is identical to SEQ ID NO: 208. See image below.
Regarding claim(s) 4 and 12, McSwiggen et al discloses, “In one embodiment, a siNA molecule of the invention comprises modified nucleotides while maintaining the ability to mediate RNAi. The modified nucleotides can be used to improve in vitro or in vivo characteristics such as stability, activity, and/or bioavailability. For example, a siNA molecule of the invention can comprise modified nucleotides as a percentage of the total number of nucleotides present in the siNA molecule. As such, a siNA molecule of the invention can generally comprise about 5% to about 100% modified nucleotides (e.g., about 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95% or 100% modified nucleotides).”, (see page 15, lines 19-27).
Regarding claim(s) 25 and 26, McSwiggen et al discloses, “In one embodiment, siNA molecules of the invention are used as reagents in ex vivo applications. For example, siNA reagents are introduced into tissue or cells that are transplanted into a subject for therapeutic effect... These extracted cells are contacted with siNAs targeting a specific nucleotide sequence within the cells under conditions suitable for uptake of the siNAs by these cells (e.g. using delivery reagents such as cationic lipids, liposomes and the like or using techniques such as electroporation to facilitate the delivery of siNAs into cells).”, (see page 52, paragraph 2).
Regarding claim 27, McSwiggen et al discloses, “The sterile injectable preparation can also be a sterile injectable solution or suspension in a non-toxic parentally acceptable diluent or solvent, for example as a solution in 1,3- butanediol. Among the acceptable vehicles and solvents that can be employed are water, Ringer's solution and isotonic sodium chloride solution.”, (see page 123, paragraph 1).
Thus, claim(s) 1, 4, 12, 25-27, and 51 are rejected as being anticipated by McSwiggen et al.
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 2, 4, 12-16, 18, 25-27, and 52 are rejected under 35 U.S.C. 103 as being unpatentable over Roch et al (US 2004/0226056 A1; published November 11th, 2004) as applied to claim 1 above, and further in view of Nair et al (WO 2019/217459 A1, published November 14th, 2019; cited as #289 under Foreign Patent Documents on IDS filed 02/09/2024).
Roch et al teaches a double stranded siRNA for inhibiting expression of APP, comprising a sense and antisense strain (seen above).
Regarding claim 2, siRNA4 of Figure 59 of Roch et al comprises at least one modified nucleotide, and a double stranded region of 19 nucleotides (see image below). Wherein the solid boxes are the modifications, and the dotted box is the double-stranded region.
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Roch et al does not teach one or more lipophilic moieties conjugated to the sense or antisense strand.
Regarding claim(s) 2, 4 and 12, Nair et al teaches, “In one embodiment, the lipophilic moiety is conjugated to one or more internal positions on at least one strand, which include all positions except the terminal two positions from each end of the strand. In one embodiment, the lipophilic moiety is conjugated to one or more internal positions on at least one strand, which include all positions except the terminal three positions from each end of the strand.”, (see paragraph [0020]).
Moreover, Nair et al teaches, “In one embodiment, the lipophilic moiety is conjugated to one or more internal positions on at least one strand, which exclude the cleavage site region of the sense strand. For instance, the internal positions exclude positions 9-12 counting from the 5’-end of the sense strand. … Alternatively, the internal positions exclude positions 11-13 counting from the 3’-end of the sense strand. In one embodiment, the lipophilic moiety is conjugated to one or more internal positions on at least one strand, which exclude the cleavage site region of the antisense strand. For instance, the internal positions exclude positions 12-14 counting from the 5’-end of the antisense strand. In one embodiment, the lipophilic moiety is conjugated to one or more internal positions on at least one strand, which exclude positions 11-13 on the sense strand, counting from the 3’-end, and positions 12-14 on the antisense strand, counting from the 5’-end.”, (see paragraphs [0027] to [0029]).
Lastly, Nair et al teaches “Accordingly, conjugating the lipophilic moieties to the internal position(s) of the double-stranded iRNA agent provides optimal hydrophobicity for the enhanced in vivo delivery of siRNA.”, (see paragraph [0103]). Also see Figure 1 and 12.
Regarding claim 13, Nair et al teaches, “In one embodiment, one or more lipophilic moieties are conjugated to one or more of the following internal positions: positions 4-8 and 13-18 on the sense strand, and positions 6-10 and 15-18 on the antisense strand, counting from the 5’end of each strand. In one embodiment, one or more lipophilic moieties are conjugated to one or more of the following internal positions: positions 5, 6, 7, 15, and 17 on the sense strand, and positions 15 and 17 on the antisense strand, counting from the 5’end of each strand.”, (see paragraphs [0030] to [0031]).
Regarding claim 14, Nair et al teaches, a C16 ligand on page 222-223, labeled Uhd. See image below. Also see Figure 12.
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Regarding claim 15, Nair et al teaches, “In some embodiments, the lipophilic moiety is an aliphatic, cylic such as alicyclic, or polycyclic such as polyalicyclic compound, such as a steroid (e.g., sterol) or a linear or branched aliphatic hydrocarbon. Exemplary lipophilic moieties are lipid, cholesterol, retinoic acid, cholic acid, adamantane acetic acid, 1-pyrene butyric acid, dihydrotestosterone, 1,3-bis- O(hexadecyl)glycerol, geranyloxyhexyanol, hexadecylglycerol, borneol, menthol, 1,3- propanediol, heptadecyl group, palmitic acid, myristic acid, O3-(oleoyl)lithocholic acid, O3- (oleoyl)cholenic acid, ibuprofen, naproxen, dimethoxytrityl, or phenoxazine.”, (see paragraph [0009]).
Further, Nair et al teaches, “In some embodiments, the lipophilic moiety is conjugated to a nucleobase, sugar moiety, or internucleosidic linkage of the double-stranded iRNA agent.”, (see paragraph [0037]).
Regarding claim 16, Nair et al teaches, “In some embodiments, the double-stranded iRNA agent further comprises a phosphate or phosphate mimic at the 5’-end of the antisense strand. In one embodiment, the phosphate mimic is a 5’-vinyl phosphonate (VP).”, (see paragraph [0038]),
Regarding claim 18, Nair et al teaches, “In other embodiments, at least one of the linkers (tethers) is a bio-clevable linker selected from the group consisting of DNA, RNA, disulfide, amide, functionalized monosaccharides or oligosaccharides of galactosamine, glucosamine, glucose, galactose, mannose, and combinations thereof.”, (see paragraph [0016]; see Figure 1 and 3).
Regarding claim 25, Nair et al teaches in Figures 19-24 a cell containing a dsRNAi agent.
Regarding claims 26-27, Nair et al teaches, “In one embodiment, the delivery vehicle can deliver an siRNA compound, e.g., a double-stranded siRNA compound, or ssiRNA compound, (e.g., a precursor, e.g., a larger siRNA compound which can be processed into a ssiRNA compound, or a DNA which encodes an siRNA compound, e.g., a double-stranded siRNA compound, or ssiRNA compound, or precursor thereof) to a cell by a topical route of administration. The delivery vehicle can be microscopic vesicles. In one example the microscopic vesicles are liposomes. In some embodiments the liposomes are cationic liposomes. In another example the microscopic vesicles are micelles. In one aspect, the invention features a pharmaceutical composition including an siRNA compound, e.g., a double-stranded siRNA compound, or ssiRNA compound, (e.g., a precursor, e.g., a larger siRNA compound which can be processed into a ssiRNA compound, or a DNA which encodes an siRNA compound, e.g., a double- stranded siRNA compound, or ssiRNA compound, or precursor thereof) in an injectable dosage form. In one embodiment, the injectable dosage form of the pharmaceutical composition includes sterile aqueous solutions or dispersions and sterile powders. In some embodiments the sterile solution can include a diluent such as water; saline solution; fixed oils, polyethylene glycols, glycerin, or propylene glycol.”, (see paragraph [0696]).
Regarding claim 52, Nair et al teaches in example 3, modifying and refining sense and antisense sequences with an internal lipophilic moiety. More specifically, “In vitro activity of F12 siRNA’s having a C16 modification in one of the internal positions in primary cyno hepatocytes showed that there are regions in siRNA duplexes where the C16-conjugate is tolerated and all positions are not equally active. Table 3. siRNAs used for positional impact of lipophilic modification (C16) across the siRNA sequences (F12).”, (see page 224).
More specifically, in the first iteration of modifying F12 sense and antisense strands, the C16 was placed in almost every possible position to see how that would affect activity, see Table 3 starting on page 225 (also Figure 24 in regard to mTTR silencing). However, Duplex AD-75868.17 positioned the C16 in the 6th position from the 5’ end of the sense strand preceded by five 2’-MOE modifications, and followed by a 2’F modification, a 2’MOE, three 2’Fs in a row, and then ten 2’MOE modifications. Then, Nair et al took those modifications that were more active and applied them to mTTR targeting sense strands, see table 5 on page 234. Duplex AD-74954.1 followed the same modification pattern as AD-75868.17’s sense strands position and had an HSA binding Kd of 155uM (see table 4 and page 234). Lastly, example 17 further refined SOD1 target siRNA by following a modification pattern similar to both AD-74954.1 and AD-75686.17, however this time both AD-401824 and AD-401825 contained phosphorothioate bonds between the first and second, and second and third nucleotides counting from the 5’ end, and this was repeated on the 3’ end. As well as AD-401824 contained a 5’ VP on the antisense strand. See image below for example 17.
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Nair et al teaches, “Table 6 shows the SOD1 siRNAs modified with different chemistry. Control is aCSF. Figures 16A-16B show the results of silencing of SOD1 with SOD1 siRNAs modified with different chemistry at various doses. As shown in the Figures 16A-16B, superior silencing was achieved with modified SOD1 siRNAs as compared to parent SOD1 siRNA, at the dosage level of 10-fold lower.”, (see paragraph [0856]).
Lastly, Nair et al teaches in Figure 24, that the mTTR silencing siRNA with both a 5’VP and a C16 (Duplex AD-397372) or C16 alone (Duplex AD-307571), both of which showed some of the lowest %mTTR remaining in the eye at Day 14.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the siRNA4 targeting APP as disclosed by Roch et al, with an internally positioned C16-lipophillic moiety as taught by Nair et al, to yield the predictable results of providing optimal hydrophobicity for enhanced in vivo delivery of siRNA as taught by Nair et al. One of ordinary skill in the art would have chosen conjugating the C-16 ligand to the 6th internal position for ensuring optimal activity of the siRNA as taught by Nair et al in example 13, example 17, and Figures 16A-16B, and 24.
Regarding the patterning of the modifications for SEQ ID NOs: 60 and 97 (of claim 52), it would have been obvious to try to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the siRNA4 of Roch et al, with the modification pattern of duplex AD-401824 as taught by Nair et al to yield the predictable results of achieving superior silencing at a dosage level of 10-fold lower, as taught by Nair et al. Nair et al teaches (above in table 6) the following modification pattern for the sense strand (where M = 2’MOE, F= 2’ Fluro, and *= a phosphorothioate bond):
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
M*
M*
M
M
M
C16
F
M
F
F
F
M
M
M
M
M
M
M
M*
M*
M
Compared to the modification pattern disclosed in instant SEQ ID NO: 60:
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
M*
M*
M
M
M
C16
F
M
F
F
F
M
M
M
M
M
M
M
M*
M*
M
Nair et al teaches (above in table 6) the following modification pattern for the antisense strand (where M = 2’MOE, F= 2’ Fluro, ^ = a vinyl phosphate, and *= a phosphorothioate bond):
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
^M*
F*
M
M
M
F
M
F
F
M
M
M
M
F
M
F
M
M
M
M
M*
M*
M
Compared to the modification pattern disclosed in instant SEQ ID NO: 97:
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
M*
F*
M
M
M
F
M
F
F
M
M
M
M
F
M
F
M
M
M
M
M*
M*
M
Accordingly, claim(s) 2, 4, 12-16, 18, 25-27, and 52 are unpatentable over Roch et al in view of Nair et al.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Khvorova et al (US 7635771 B2; published December 22nd, 2009) discloses, “Efficient sequence specific gene silencing is possible through the use of siRNA technology. By selecting particular siRNAs by rational design, one can maximize the generation of an effective gene silencing reagent, as well as methods for silencing genes. Methods, compositions, and kits generated through rational design of siRNAs are disclosed including those directed to nucleotide sequences for APP.” (abstract). More specifically, SEQ ID NO: 455 which is identical to SEQ ID NO: 171 and complementary to SEQ ID NO: 208.
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No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LEXUS M TATGE whose telephone number is (571)272-0061. The examiner can normally be reached Monday-Friday: 8:30am to 5:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Dunston can be reached at (571) 272-2916. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/L.M.T./Examiner, Art Unit 1637
/Jennifer Dunston/Supervisory Patent Examiner, Art Unit 1637
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