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 . The amendment filed on 05/24/2023 has been entered. Claims 3, 8-11, 20-31, 34, 39, and 40 are cancelled. Claims 1, 2, 4-7, 12-19, 32, 33, and 35-38 are pending in this application. Claims 1, 2, 5, 12-19, 35, and 38 are withdrawn. Claims 4, 6, 7, 32, 33, 36, and 37 are currently under examination.
Priority
This is US Application 17/950,520 of 09/22/2022 and claims US PRO 63/246,870 of 09/22/2021.
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 63/246,870, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Claims 4, 6, 7, 32, 33, 36, and 37 recite “two Ra on two adjacent carbon atoms, together with the two adjacent carbon atoms, form a double bond” and/or “in Table C”, which are not disclosed or in the same scope in the prior-filed Application No. 63/246,870. Thus, the priority date of claims 4, 6, 7, 32, 33, 36, and 37 is 09/22/2022.
Election/Restrictions
Applicant's election without traverse of Group III invention (claims 4-7, 12-19, 32, 33, and 35-37, drawn to a conjugate) and species (Duplex 5: a sense strand (5'→3') being [mUs][mAs][mG][mA][mC][fC] [mU][fG][fU][fU][fU][mU][mG][mC][G2][G2][mU][mUs][mGs][mA] and an antisense strand (5'→3') being [mUs][fCs][fA][mA][fA][mA][fG][mC][mA][fA][mA][mA][mC][fA][mG][fG][mU][mC][mU][mAs][mGs][mA]. Each [G2] corresponds to a Linker Unit-Ligand, and one or more Nucleic Acid Agents comprise the remaining nucleotides. That is, [G2] corresponds to:
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and
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, wherein # indicates an attachment to Ligand, ## indicates an attachment to Nucleic Acid Agent) in the reply filed on 10/01/2025 is acknowledged. Claims 1, 2, 5, 12-19, 35, and 38 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention or species, there being no allowable generic or linking claim. Thus, claims 4, 6, 7, 32, 33, 36, and 37 are currently under examination.
Information Disclosure Statement
Two information disclosure statements (IDS) filed on 01/12/2023 and 05/24/2023 have been considered.
Nucleotide and/or Amino Acid Sequence Disclosures
Summary of Requirements for Patent Applications Filed On Or After July 1, 2022, That Have Sequence
Disclosures
37 CFR 1.831(a) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.831(b) must contain a “Sequence Listing XML”, as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.831-1.835. This “Sequence Listing XML” part of the disclosure may be submitted:
1. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter “Legal Framework”) in XML format, together with an incorporation by reference statement of the material in the XML file in a separate paragraph of the specification (an incorporation by reference paragraph) as required by 37 CFR 1.835(a)(2) or 1.835(b)(2) identifying:
a. the name of the XML file
b. the date of creation; and
c. the size of the XML file in bytes; or
2. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation by reference statement of the material in the XML format according to 37 CFR 1.52(e)(8) and 37 CFR 1.835(a)(2) or 1.835(b)(2) in a separate paragraph of the specification identifying:
a. the name of the XML file;
b. the date of creation; and
c. the size of the XML file in bytes.
SPECIFIC DEFICIENCIES AND THE REQUIRED RESPONSE TO THIS NOTICE ARE AS FOLLOWS:
Specific deficiency - This application fails to comply with the requirements of 37 CFR 1.831-1.834 because it does not contain a “Sequence Listing XML” as a separate part of the disclosure. A “Sequence Listing XML” is required because Table 1 (page 221 of the Specification) contains 5 Duplex sequences, each strand of more than 10 nucleotides, but there is no corresponding SEQ ID NO and sequencing list.
Required response - Applicant must provide:
• A “Sequence Listing XML” part of the disclosure, as described above in item 1. or 2.; together with
o A statement that indicates the basis for the amendment, with specific references to particular parts of the application as originally filed, as required by 37 CFR 1.835(a)(3);
o A statement that the “Sequence Listing XML” includes no new matter as required by 37 CFR 1.835(a)(4)
AND
• A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required incorporation by reference paragraph as required by 37 CFR 1.835(a)(2), consisting of:
o A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
o A copy of the amended specification without markings (clean version); and
o A statement that the substitute specification contains no new matter.
Claim Objections
Claim 32 is objected to because of the following informalities: In claim 32, change the incorrect recitation “the conjugates” (line 2) to “one or more of the Compounds” to be consistent with the name in Table C. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claims 4, 6, 7, 32, 33, 36, and 37 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claims 6, 7, 32, 33, 36, and 37 depend from or rely on claim 4 conjugate.
“To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116. However, a showing of possession alone does not cure the lack of a written description. Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 969-70, 63 USPQ2d 1609, 1617 (Fed. Cir. 2002). For example, it is now well accepted that a satisfactory description may be found in originally-filed claims or any other portion of the originally-filed specification. See In re Koller, 613 F.2d 819, 204 USPQ 702 (CCPA 1980); In re Gardner, 475 F.2d 1389, 177 USPQ 396 (CCPA 1973); In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). However, that does not mean that all originally-filed claims have adequate written support. The specification must still be examined to assess whether an originally-filed claim has adequate support in the written disclosure and/or the drawings”. See MPEP 2163 [R-01.2024][I]. “The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A), above), reduction to drawings (see i)(B), above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus (see i)(C), above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. A “representative number of species” means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. The disclosure of only one species encompassed within a genus adequately describes a claim directed to that genus only if the disclosure “indicates that the patentee has invented species sufficient to constitute the gen[us].” See Enzo Biochem, 323 F.3d at 966, 63 USPQ2d at 1615; Noelle v. Lederman, 355 F.3d 1343, 1350, 69 USPQ2d 1508, 1514 (Fed. Cir. 2004) (Fed. Cir. 2004) (“[A] patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there may be unpredictability in the results obtained from species other than those specifically enumerated.”)”. See MPEP § 2163 [R-01.2024] [II.A.3.(a).ii)].
Claim 4 recites “Linker Unit independently is…
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,
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, or
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” (lines 3 to 4 on page 6). However, the specification disclosed linkage of the
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moiety to the carbon 2, not carbon 3, of the ribose only as the
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,
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, or
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, that are also exemplified in (i) Table L (pages 24-39), (ii) Table S1 (pages 56-58), (iii)Table S2 (pages 61-99), (iv) Table C (pages 105-143), and (v) Examples (pages 216-221). A careful review of the specification does not appear to specifically teach representative “Linker Unit independently is…
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,
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, or
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”. Moreover, the specification does not appear to teach or suggest any structural feature which are common to the claimed “Linker Unit independently is…
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, or
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”. Also, there is no evidence in the literature to support the above claimed limitations (see the attached STN search results) and thus the limitations recited in the claims are unpredictable.
In the absence of physical, chemical, and/or biological characteristics that are shared by members of the genus of “Linker Unit independently is…
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, or
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”; one of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to describe the genus. Thus, Applicant was not in possession of the claimed genus.
Claim Rejections - 35 USC § 102/103
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.
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.
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.
(I) Claims 4, 6, 7, 33, 36, and 37 are rejected under 35 U.S.C. 102(a)(1) or 102(a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Wang et al. (WO 2021/067744, published April 08, 2021, filed on October 02, 2020, and benefitted by US PRO 62/909,278 fled on October 02, 2019, hereinafter referred to as Wang ‘744) incorporated by Brown et al. (WO 2016/100401, June 23, 2016, hereinafter referred to as Brown ‘401, also listed in IDS filed on 01/12/2023).
With regard to structural limitations “a conjugate comprises: (i) one or more Nucleic Acid Agent; (ii) one or more Ligand; and (iii) one or more Linker Unit, wherein each Linker Unit independently is
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, wherein B is a nucleobase moiety (or adenine (A) or guanine (G)), each Ra is H; each Rb is H; R1 is H; R2 is H; R3 is H; R4 is H; each R5 is H; n is an integer of 1; # indicates an attachment to the Ligand (or
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), and ## indicates an attachment to the Nucleic Acid Agent (or an oligonucleotide)” (claims 4, 6, 7, 33, and 36), and “a pharmaceutical composition comprising the conjugate of claim 4” (claim 37):
Wang ‘744 disclosed in some embodiments, an oligonucleotide comprises a monovalent GalNAc attached to an adenine nucleotide, referred to as [ademA-GalNAc] or 2'-aminodiethoxymethanol-Adenine-GalNAc, as depicted below.
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. An example of such conjugation is shown below for a loop comprising from 5' to 3' the nucleotide sequence GAAA (L = linker, X = heteroatom) stem attachment points are shown.
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. In the chemical formula,
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is used to describe an attachment point to the oligonucleotide strand. Acetal-based linkers are disclosed, for example, in International Patent Application Publication Number WO2016100401A1, and the contents of which is incorporated herein by reference in its entirety. "[prgA-peg-GalNAc]" refers to an A nucleotide having a 2'-GalNAc conjugate:
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(pages 47/107 to 49/107, [0106-0108]; page 38/107, para. 2). An antisense strand having the sugar moiety of each of the nucleotides at positions 2, 5, and 14 of the antisense strand modified with 2'-F and the sugar moiety of each of the remaining nucleotides of the antisense strand modified with a modification selected from the group consisting of 2'-O-propargyl, 2'-O-propylamin, 2'-amino, 2'-ethyl, 2'-aminoethyl (EA), 2'-O-methyl (2'-OMe), 2'-O-methoxyethyl (2'-MOE), 2'-O-[2-(methylamino)-2-oxoethyl] (2'-O-NMA), and 2'-deoxy-2'fluoro-ß-d-arabinonucleic acid (2'-FANA) (page 20/107, [0058]). In some embodiments, methods are provided for delivering to a cell an effective amount any one of oligonucleotides disclosed herein for purposes of reducing expression of RNA in the cell. Exemplary target genes include, Factor VII, Eg5, PCSK9, TPX2 (page 53/107, [0120]; page 57/107, [0132]). Brown ‘401 (incorporated by reference for the amide linkage to GalNAc ligand) disclosed that the mode of conjugation of ligand to nucleotide can occur through post synthetic conjugation via click chemistry or amide chemistry or solid phase synthesis using ligand phosphoramidites. Example 41. Synthesis of GalNAc amidite synthons:
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: 5' -DM T-2'-O-propargyl-N-bzA:
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; CuSO4.5H2O and sodium ascorbate (2.0) were added under nitrogen to give
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(pages 203/426 to 207/426, [00650-00658]).
Thus, these teachings of Wang ‘744 incorporated by Brown ‘401 anticipate Applicant’s claims 4, 6, 7, 33, 36, and 37 because (a) Wang ‘744 teaches the nucleotide sequence GAAA (L = linker, X = heteroatom) and (b) 2'-aminoethyl (=
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) is also taught along with 2'-O-aminodiethoxymethanol and 2’-O-propargyl-peg-NH2 by Wang ‘744 to substitute 2’-OH of ribose and contains amine group to form amide linkage to Compound 6 of Brown ‘401, described above. Or, in an alternative, skilled artisan would substitute the 2'-O-aminodiethoxymethanol or 2’-O-propargyl-peg-NH2 with 2'-aminoethyl of Wang ‘744 to form amide linkage to Compound 6 of Brown ‘401.
(II) Claims 4, 6, 7, 32, 33, 36, and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (WO 2021/067744, published April 08, 2021, filed on October 02, 2020, and benefitted by US PRO 62/909,278 fled on October 02, 2019, hereinafter referred to as Wang ‘744) incorporated by Brown et al. (WO 2016/100401, June 23, 2016, hereinafter referred to as Brown ‘401) as evidenced by NCBI blast of elected Duplex 5. Claims 4, 6, 7, 33, 36, and 37 have been rejected by Wang ‘744 incorporated by Brown ‘401 under 102/103 above and thus are incorporated entirely by reference here.
With regard to the structural limitations “a sense strand (5'→3') being [mUs][mAs][mG][mA] [mC][fC][mU][fG][fU][fU][fU][mU][mG][mC][G2][G2][mU][mUs][mGs][mA] and an antisense strand (5'→3') being [mUs][fCs][fA][mA][fA][mA][fG][mC][mA][fA][mA][mA][mC][fA][mG][fG][mU][mC][mU] [mAs][ mGs][mA]. Each [G2] corresponds to a Linker Unit-Ligand, and one or more Nucleic Acid Agents comprise the remaining nucleotides. That is, [G2] corresponds to:
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and
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, wherein # indicates an attachment to Ligand, ## indicates an attachment to Nucleic Acid Agent”, required by elected Duplex 5 and claim 32.
Wang ‘744 further disclosed sense-antisense duplex sequence in Table A:
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"M" refers to a 2'-OMe modified nucleotide; "F" refers to a 2'-F modified nucleotide; "S" refers to a nucleotide with a 3'-phosphorothioate linkage; "{MS}" refers to a 2'-OMe modified nucleotide with a 3'-phosphorothioate linkage; "{FS}" refers to a 2'-F modified nucleotide with a 3'-phosphorothioate linkage; "[prg-peg-GalNAc]" refers to a nucleotide having a 2'-GalNAc conjugate:
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; "{Px-FS}" refers to a 2'-F modified nucleotide with a 3'-phosphorothioate linkage, and 5' phosphonate or vinylphosphonate; "{Px-MS}" refers to a 2'-OMe modified nucleotide with a 3'-phosphorothioate linkage, and 5' phosphonate or vinylphosphonate (page 37/107, Table A and para. 1). NCBI blast (cited here as evidence for Query of the elected antisense 5’-UAGACCUGUUUUGCUUUUGA-3’) shows 100% identities to several variants of Homo sapiens proprotein convertase subtilisin/kexin type 9 (PCSK9, T in DNA corresponds to U in RNA):
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.
Thus, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to substitute the sense-antisense duplex sequence in Table A with a sense-antisense duplex sequence targeting to PCSK9 and the 2’-O-prg-peg-amine with 2’-propylamine for linking to GalNAc ligand, respectively, as taught by Wang ‘744 incorporated by Brown ‘401 because PCSK9 is intended target and 2'-O-propylamine or 2'-aminoethyl is another intended modification at 2’ position of ribose to form amide linkage with ligand, described above.Thus, one of skill in the art would have a reasonable expectation that by substituting the sense-antisense duplex sequence in Table A with a sense-antisense duplex sequence targeting to PCSK9 and the 2’-O-prg-peg-amine with 2’-propylamine for linking to GalNAc ligand, respectively, as taught by Wang ‘744 incorporated by Brown ‘401, one would achieve Applicant’s claims 4, 6, 7, 32, 33, 36, and 37. "Exemplary rationales that may support a conclusion of obviousness include: (B) Simple substitution of one known element for another to obtain predictable results". See MPEP § 2143 [R-01.2024] [I].
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.
(I) Claims 4, 6,7, 36, and 37 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2, 43, and 48 of copending Application No. 18/654,816 (Applicant: Sanegene Bio USA Inc., the claim set of 08/30/2024). Although the claims at issue are not identical, they are not patentably distinct from each other because Appl ‘816 claims “A conjugate or a pharmaceutically acceptable salt thereof, comprising: (i) one or more Nucleic Acid Agent (or an oligonucleotide); and (ii) one or more Lipid-Based Ligand Unit, wherein each Lipid-Based Ligand Unit independently is…
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, wherein L is a lipid moiety; B is H, C1-C6 alkyl, or a nucleobase moiety; V is -O-, -NRv-, or-C(Rv)2-… each Ra independently is H, halogen, or C1-C6 alkyl optionally substituted with one or more halogen; R1 is H, halogen, or C1-C6 alkyl optionally substituted with one or more halogen; R2 is H, halogen, or C1-C6 alkyl optionally substituted with one or more halogen; R3 is H, halogen, or C1-C6 alkyl optionally substituted with one or more halogen; R4 is H, halogen, or C1-C6 alkyl optionally substituted with one or more halogen… each R5 independently is H, halogen, or C1-C6 alkyl optionally substituted with one or more halogen; and n is an integer ranging from about 0 to about 10; and… when the Lipid-Based Ligand Unit is at the 3'-terminus of a Nucleic Acid Agent, # is an attachment to the rest of the conjugate; and ## is H, -P(Ry)2, -P(ORY)(N(Ry)2)… or when the Lipid-Based Ligand Unit is at the 5'-terminus of a Nucleic Acid Agent, # is H, -P(Ry)2, -P(ORY)(N(Ry)2)… and ## is an attachment to the rest of the conjugate” (claims 2 and 43), and “A pharmaceutical composition comprising the conjugate of claim 2” (claim 48), being encompassed by or overlapping with claims 4, 6,7, 36, and 37 of this Application. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
(II) Claims 4, 6,7, 36, and 37 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2, 35, and 36 of copending Application No. 18/782,288 (Applicant: Sanegene Bio USA Inc., the claim set of 08/30/2024). Although the claims at issue are not identical, they are not patentably distinct from each other because Appl ‘288 claims “A conjugate or a pharmaceutically acceptable salt thereof, comprising: (i) one or more Nucleic Acid Agent (or an oligonucleotide); (ii) one or more Ligand; and (iii) one or more Lipid-Based Enhancement Unit, wherein each Lipid-Based Enhancement Unit independently is:…
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, wherein L is a lipid moiety; B is H, C1-C6 alkyl, or a nucleobase moiety; V is -O-, -NRv-, or-C(Rv)2-… each Ra independently is H, halogen, or C1-C6 alkyl optionally substituted with one or more halogen; R1 is H, halogen, or C1-C6 alkyl optionally substituted with one or more halogen; R2 is H, halogen, or C1-C6 alkyl optionally substituted with one or more halogen; R3 is H, halogen, or C1-C6 alkyl optionally substituted with one or more halogen; R4 is H, halogen, or C1-C6 alkyl optionally substituted with one or more halogen… each R5 independently is H, halogen, or C1-C6 alkyl optionally substituted with one or more halogen; and n is an integer ranging from about 0 to about 10; and… when the Lipid-Based Ligand Unit is at the 3'-terminus of a Nucleic Acid Agent, # is an attachment to the rest of the conjugate; and ## is H, -P(Ry)2, -P(ORY)(N(Ry)2)… or when the Lipid-Based Ligand Unit is at the 5'-terminus of a Nucleic Acid Agent, # is H, -P(Ry)2, -P(ORY)(N(Ry)2)… and ## is an attachment to the rest of the conjugate” (claims 2 and 35), and “A pharmaceutical composition comprising the conjugate of claim 2” (claim 36), being encompassed by or overlapping with claims 4, 6,7, 36, and 37 of this Application. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
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/YIH-HORNG SHIAO/Primary Examiner, Art Unit 1691