DETAILED ACTION
Election/Restrictions
Applicant’s election without traverse of Group I and Formula 5 in the reply filed on August 28 2025 is acknowledged. In light of the prior art, the species election with regards to the conjugate has been expanded to all species of formula I. Claims 1-4, 6-15 and 26 are pending in the application. Claims 6-15 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on August 28 2025. Accordingly, claims 1-4 and 26 are being examined on the merits herein.
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
This application is a 371 of PCT/JP2020/034022 (09/09/2020) which claim priority to JAPAN 2019-164564 (09/10/2019) as reflected in the filing receipt issued on May 15 2023.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on February 17 2023, January 12 2024 and May 29 2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings are objected to for the following reasons:
37 CFR 1.84 (u)(1) states “View numbers must be preceded by the abbreviation "FIG."”
In the current case, the view numbers for Figures 1-6 are preceded by the word "Figure" instead of the abbreviation "FIG.".
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," 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 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) 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") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) 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 of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency - This application fails to comply with the requirements of 37 CFR 1.821 - 1.825 because the application does not contain a statement that the CRF is identical to the "Sequence Listing" part of the disclosure, as described above in item 1), as required by 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii).
Required response - Applicant must provide such statement.
Specific deficiency - The Incorporation by Reference paragraph required by 37 CFR 1.821(c)(1) is missing or incomplete. See item 1) a) or 1) b) above.
As noted above, the size of the ASCII text file in bytes.
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference paragraph, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Claim Rejections - 35 USC § 112-Written Description
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 1-4 and 26 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims are directed to conjugate of an oligonucleotide which has a pharmacological effect in hepatic parenchymal cells wherein the conjugate is delivered specifically to hepatic parenchymal cells in vivo and the oligonucleotide with activity on a target gene (claim 1). The oligonucleotide is specifically claimed as suppressing expression of the target gene (claim 26).
The specification discloses specific sequences, such as SEQ ID NO: 1-48 and 93-96 which are directed to antisense oligonucleotides, and also teaches targets genes with expression in the liver which meet the written description and enablement provisions of 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph. However, claim(s) 1-4 and 26 is(are) directed to encompass any oligonucleotide which is delivered to hepatic parenchymal cells but has activity on any target gene, which only correspond in some undefined way to specifically instantly disclosed chemicals. The oligonucleotides recited in the claims meet the written description provision of 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, due to lacking chemical structural information for what they are and chemical structures are highly variant and encompass a myriad of possibilities. The specification provides insufficient written description to support the genus encompassed by the claim. Note: MPEP 2163.
Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, (Fed. Cir. 1991), makes clear that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed." (See page 1117.) The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." (See Vas-Cath at page 1116.)
Univ. of Rochester v. G.D. Searle, 69 USPQ2d 1886, 1892 (CAFC 2004), further supports this by stating that:
The appearance of mere indistinct words in a specification or a claim, even an original claim, does not necessarily satisfy that requirement. A description of an anti-inflammatory steroid, i.e., a steroid (a generic structural term) described even in terms of its functioning of lessening inflammation of tissues fails to distinguish any steroid from others having the same activity or function. A description of what a material does, rather than of what it is, usually does not suffice…. The disclosure must allow one skilled in the art to visualize or recognize the identity of the subject matter purportedly described. (Emphasis added).
With the exception of the above specifically disclosed chemical structures, the skilled artisan cannot envision the detailed chemical structure of the encompassed oligonucleotides, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it. The chemical structure itself is required. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (Fed. Circ. 1993) and Amgen Inc. V. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016, (Fed. Cir. 1991). In Fiddes v. Baird, 30 USPQ2d 1481, 1483, (Bd. Pat. App. & Int. 1993), claims directed to mammalian FGF's were found unpatentable due to lack of written description for the broad class. The specification provided only the bovine sequence. Finally, University of California v. Eli Lilly and Co., 43 USPQ2d 1398, 1404, 1405 (Fed. Cir. 1997) held that:
...To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997); In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (" [T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed."). Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966.
Furthermore, to the extent that a functional description can meet the requirement for an adequate written description, it can do so only in accordance with PTO guidelines stating that the requirement can be met by disclosing “sufficiently detailed, relevant identifying characteristics,” including “functional characteristics when coupled with a known or disclosed correlation between function and structure.” Univ. of Rochester v. G.D. Searle, 68 USPQ2d 1424, 1432 (DC WNY 2003).
Manoharan et al. (USPGPUB NO. 20090239814) recognizes that carbohydrate conjugated iRNA agents target parenchymal cells of the liver (paragraph 0016). It is specifically taught that the carbohydrate ligand can increase delivery of iRNA to the liver and therefore the iRNA can be useful for targeting a gene for which expression is undesired in the liver (paragraph 0017). Similar carbohydrates to the instant claims are taught in Manoharan et al. Therefore, the state of the art clearly supports that the conjugate as claimed can be delivered to the liver and reduce gene expression in the liver.
Ahn et al. (Experimental & Molecular Medicine 2023) teaches RNA interference is mediated by small interfering (siRNAs) which has been exploited for the development of therapeutics. siRNAs determine targets based on their sequence and specifically regulate the gene expression of the target gene. However, efficient delivery of siRNAs to the target organ has long been an issue that needs to be solved. siRNA drugs have been approved by the FDA which target the hepatocytes of the liver. The liver, eye and skin are the preferred organs targeted by siRNAs (abstract). However organs in which it is challenging to deliver siRNA include the lungs, kidneys and brain. It is taught that siRNA targeting the lung, kidney and brain has rarely progressed to the clinical stage because there are many barriers (page 1288-1290). It is taught that the liver has the hepatocyte-specific receptor ASGPR to which GalNAc-conjugated siRNAs can bind with high affinity (page 1290, conclusion).
Therefore, only the above chemically structurally defined chemicals, but not the full breadth of the claim(s) meet the written description provision of 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph. The species specifically disclosed are not representative of the genus because the genus is highly variant. As set forth above, there significant challenges to delivery siRNA outside the liver. While the state of the art supports the expectation that oligonucleotides conjugates as claimed can be delivered to the liver and target genes in the liver, the state of the art does not support that the conjugates can be used with any oligonucleotide and target any gene. Since the ability to target genes is based on the sequence of the oligonucleotide as taught by Ahn et al., the specification fails to provide written description support for all oligonucleotides over the full scope of the claims. Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 USC § 112 is severable from its enablement provision. (See page 1115.)
Claim Rejections - 35 USC § 112-Indefiniteness
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.
Claims 1-4 and 26 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 “wherein the conjugate is delivered specifically to hepatic parenchymal cells”. Claim 1 is directed to a conjugate of an oligonucleotide, i.e. a product. However, the recitation is delivered is an active method step. MPEP 2173.05(p) makes it clear that “a single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. See In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 1318, 97 USPQ2d 1737, 1748-49 (Fed. Cir. 2011).”
Claims 2-4 and 26 are included in the rejection as they depend on a rejected base claim and they do not clarify the issues.
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.
(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) 1-4 and 26 is/are rejected under 35 U.S.C. 102 (a)(1) and/or 102(a)(2) as being anticipated by Koizumi et al. (WO2019172286).
The applied reference has a common applicant and joint inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Applicant cannot rely upon the certified copy of the foreign priority application to overcome this rejection because a translation of said application has not been made of record in accordance with 37 CFR 1.55. When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP §§ 215 and 216.
Therefore, Koizumi et al. constitutes prior art under both 102(a)(1) and 102(a)(2).
The instant application claims a conjugate of an oligonucleotide having a pharmacological effect in hepatic parenchymal cells with a biantennary GalNAc of formula 1.
Koizumi et al. (wherein USPGPUB No. 20200407394 is serving as the English language equivalent) claims an oligonucleotide wherein a GalNAc unit is bound to the 5’end and/or the 3’end. The GalNAc unit is represented by formula I which is the same as instantly claimed. Specific GalNAc claimed include Formula 31 (X19), formula 32 (X20), formula 33 (X21) and formula 34 (X22) which are the same as instant claim 4 (claim 24). Sequences of oligonucleotides claimed include SEQ ID NO: 1 which is the same as the instant application (see alignment below):
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Therefore, Koizumi et al. teaches the same oligonucleotide with the same GalNAc unit. Regarding the claimed delivery to hepatic parenchymal cells, Koizumi et al. teaches that conjugates covalently bound to N-acetyl-D-galactosamine (GalNAc) are delivered to hepatic parenchymal cells (paragraph 0003).
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1-4 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Hansen et al. (USPGPUB No. 20100227914) in view of Koizumi et al. (WO2019172286).
Applicant Claims
While not claimed, Applicants in the response filed August 28 2025 pointed to an oligonucleotide of SEQ ID NO: 96. This rejection is based on rendering obvious, this particular sequence.
The instant application claims a conjugate of an oligonucleotide having a pharmacological effect in hepatic parenchymal cells with a biantennary GalNAc of formula 1.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
Hansen et al. is directed to RNA antagonist compounds for inhibition of APO-B100 expression. Claimed is an oligomeric compound wherein the nucleobase sequence is SEQ ID No: 5 (claim 10). A conjugate comprising the compound and at least one non-nucleotide or non-polynucleotide moiety covalently attached to said compound is claimed (claim 14). Conjugates include those which can increase the cellular uptake of the oligonucleotide. The conjugate can take place at the terminal positions 5’-OH or 3’-OH but the ligands may also take place at the sugar and/or bases (paragraph 0116). Conjugates include carbohydrates (paragraph 0118). It is taught that dosing once a week seemed to accumulate oligonucleotide in the liver (paragraph 0215).
As shown in the alignment below, SEQ ID NO: 5 has 100% identity to instantly claimed SEQ ID NO: 96 (Db):
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Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.02)
While Hansen et al. suggest conjugation, Hansen set al. does not expressly teach conjugation of formula 1. However, this deficiency is cured by Koizumi et al.
Koizumi et al. (wherein USPGPUB No. 20200407394 is serving as the English language equivalent) claims an oligonucleotide wherein a GalNAc unit is bound to the 5’end and/or the 3’end. The GalNAc unit is represented by formula I which is the same as instantly claimed. Specific GalNAc claimed include Formula 31 (X19), formula 32 (X20), formula 33 (X21) and formula 34 (X22) which are the same as instant claim 4 (claim 24). It is taught that conjugates covalently bound to N-acetyl-D-galactosamine (GalNAc) are delivered to hepatic parenchymal cells (paragraph 0003).
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Hansen et al. and Koizumi et al. and utilize the GalNAc conjugate of Koizumi et al. with the RNA antagonist of Hansen et al. One skilled in the art would have been motivated to utilize the GalNAc conjugate as it can deliver oligonucleotides to hepatic parenchymal cells as taught by Koizumi et al. One skilled in the art would have a reasonable expectation of success as Hansen et al. teaches that the oligonucleotide can be part of a conjugate and the conjugate can be a carbohydrate.
Regarding the claimed biantennary GalNAc, Koizumi et al. teaches the same formula 1, same formula 2 and the same X18-X22 recited in claim 4.
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 1-4 and 26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 11958878. Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims overlap in scope.
The instant application claims a conjugate of an oligonucleotide having a pharmacological effect in hepatic parenchymal cells with a biantennary GalNAc of formula 1.
Patent ‘878 claims a conjugate of an oligonucleotide and a GalNAc unit. Specific conjugates claimed are SEQ ID NO 40 and X18 and SEQ ID NO: 174 and X20. X18 and X20 are exactly the same as instantly claimed X18 and X20. As shown below SEQ ID No: 40 is the same as instantly taught SEQ ID NO: 40 and SEQ ID NO: 174 is the same as instantly taught SEQ ID NO: 95.
SEQ ID NO: 40 (Qy) and SEQ ID NO: 40 (Db)
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SEQ ID NO: 95 (Qy) and SEQ ID NO: 174 (Db)
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Therefore, the scopes of the patent claims and the instant application overlap and thus they are obvious variants of one another as both claim oligonucleotides with the same GalNAc conjugate. Regarding the claimed delivery specifically to hepatic parenchymal cells, Patent ‘878 claims the same conjugates. Note MPEP 2112.01: "Products of identical chemical composition cannot have mutually exclusive properties." A chemical composition and its properties are inseparable. Therefore, if the prior artteaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705,709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Claims 1-4 and 26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 109-111 of copending Application No. 17769483 (US PGPUB NO. 20230348522). Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims overlap in scope.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Copending ‘483 claims a method for producing an oligonucleotide. The oligonucleotide consists of a sequence represented by formula GSD AO01 to GSD A)16. This oligonucleotide includes either X18 or X20 which is the same instantly claimed. One compound claimed is SEQ ID NO: 29 with X20. As shown below SEQ ID NO: 29 is the same as instantly taught SEQ ID No: 95.
SEQ ID NO: 95 (Qy) and SEQ ID NO: 29 (Db)
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Therefore, the scopes of the copending claims and the instant application overlap and thus they are obvious variants of one another as both claim oligonucleotides with the same GalNAc conjugate. Regarding the claimed delivery specifically to hepatic parenchymal cells, Copending ‘483 claims the same conjugates. Note MPEP 2112.01: "Products of identical chemical composition cannot have mutually exclusive properties." A chemical composition and its properties are inseparable. Therefore, if the prior artteaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705,709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ABIGAIL VANHORN whose telephone number is (571)270-3502. The examiner can normally be reached M-Th 6 am-4 pm EST.
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/ABIGAIL VANHORN/Primary Examiner, Art Unit 1636