DETAILED ACTION
The examiner for your application at the USPTO has changed. Examiner Abigail VanHorn can be reached at 571-270-3502.
Election/Restrictions
Applicant’s election without traverse of Group I and
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in the reply filed on April 27 2026 is acknowledged. Upon review it was determined that the elected species falls within the scope of groups II and III. Therefore, the restriction between a compound of formula in claim 1, the compound of formula in claim 20 and the compound of formula in claim 21 is withdrawn. Considering the discovered prior art, the species election has been expanded to include H (which corresponds to position R1), as well as any number claimed of y and z. Claims 1-26 are pending in the application and 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 claims benefit of 63/343,737 (05/19/2022) as reflected in the filing receipt issued August 7 2023.
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. 6334373, 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.
While prior filed application provides support generically for oligonucleotide, the prior filed application fails to provide support for the specific sequences recited in claims 7 or 12. Therefore, the effective filing date of claims 7 and 12 is May 19 2023.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on September 19 2023 and January 9 2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 17 is objected to because of the following informalities: the claim includes various abbreviations such as GalNAc, AEEA, GABA, GLY, PA, ACA, ALA, ARA, BA, AEA, AEEP, CA, DHA, EA, EPA, HDA, LA, MA, OA, PDA, PGA, RA, SA, TDA, UDA, GluNAc, Tr, MMTr, DMTr. These abbreviations need to be spelt out the first they appear. 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.
Claims 8-12 and 21 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 8 recites the compound comprises more than one of the formula. This claim depends from claim 6 which depends from claim 1. It isn’t clear how the compounds recited would be connected to result in a compound with more than one of these formula. Since the claim is referring “the compound”, the limitation is directed to the compound not a composition. Therefore, it is unclear how the compounds are joined together to form a compound make of more than one of the formula.
The recitation “molecular weight” in claim 9 is indefinite because a person of ordinary skill in the art would not understand with reasonable certainty to which type of molecular weight the claim language is referring. Teva Pharms. USA, Inc. v. Sandoz, Inc., 789 F.3d 1335 (Fed. Cir. 2015), held that the term “molecular weight” in several polymer claims was indefinite, because the term could mean either peak average molecular weight, number average molecular weight, or weight average molecular weight. Therefore, without a clear indication of how the molecular weight is measured the claimed term is indefinite. MPEP 2173.02 II.
Claim 10 as currently written is vague and indefinite. Claim 10 depends from claim 1. The structure recited in claim 1 includes an R1 however neither claim 10 nor claim 1 includes a definition of R1. This creates uncertainty as to the scope of the compound claimed.
Claim 11 as currently written is vague and indefinite. The claim recites wherein Z1 comprises one or more of an oligonucleotide…or CH2O-trimethyloxytrityl and Z1 is
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This results in two different definitions of Z1 and creates confusion to the scope of the claim. IF Applicants intend for the Z1 is
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to be the last species of Z1 then Applicants should remove the “or” before CH2O-trimethoxytrityl.
Claim 12 recites the limitation "Z1" in line 1. There is insufficient antecedent basis for this limitation in the claim. The claim depends from claim 1 and claim 1 does not include a Z1. Perhaps Applicants meant for the claim to depend from claim 10 which does recite a Z1.
Regarding claim 21, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). See third and fifth line from the end.
Claim 21 as currently written is vague and indefinite. The claim recites “specific small molecules showing cell-targeting effects”. However, the specification never describes any of such small molecules. Therefore, the scope is unclear since the recitation “specific” indicates it isn’t any small molecule that has cell-targeting effects but specific ones, but the specification never indicates the scope of these molecules.
Claim Rejections - 35 USC § 112-Failure to further limit
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 6 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 6 is broader in scope than the claim from which it depends. Claim 6 depends from claim 6. Claim 1 states L1 is N(H) or L2 is C(O) OR L1 is C(O) and L2 is N(H). However, claim 6 recites each L1 is, independently, N(H) or C(O) and L2 is, independently, N(H) or C(O). This results in L1-L2 in the structure of N(H)-N(H) or C(O)-C(O) which is broader than the definition of L1 and L2 in claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Song et al. (WO2020222573).
The instant application claims:
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The instant specification does not provide a limiting definition of the squiggly line. Therefore, the broadest interpretation of the claims is that any atom/molecule can be attached at the squiggly line. For example:
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could mean OH or it could mean OCH2CH2O or a myriad of other functional groups.
Song et al. (wherein USPGPUB No. 20220226496 is serving as English language equivalent) is directed to ligand-drug conjugate including linker having tris structure. A specific compound exemplified is compound 47 in example 12.
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This reads on instant claim 1 wherein y is 1; z is 0 and L1 is C(O) and L2 is N(H).
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 1-5, 9-11, 13-15, 18, 20 and 23-26 are rejected under 35 U.S.C. 103 as being unpatentable over Ishihara et al. (US 6057431).
Applicant Claims
The instant application claims:
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The instant specification does not provide a limiting definition of the squiggly line. Therefore, the broadest interpretation of the claims is that any atom/molecule can be attached at the squiggly line. For example:
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could mean OH or it could mean OCH2CH2O or a myriad of other functional groups.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
Ishihara et al. is directed to a compound of general formula I:
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(claim 1) wherein a narrower compound claimed is formula 1(a):
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(claim 3).
As claimed n, p and q can be between 0 and 4 (claim 1). The recitation m can be between 0 and 10 (claim 1). The recitation r can be 0 or 1. T3-T5 can be CONH or NHCO (claim 1); F1 and F2 and be N-acetylgalactosamine (claim 2). Z is an oligonucleotide (claim 8).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.02)
Ishihara et al. does not expressly teach a compound falling within the scope claimed.
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 form a compound falling within the scope claimed by choosing from the specifically taught groups in the compounds of Ishihara et al. Specifically, selection from a finite list of alternatives is all that is required to arrive at the claimed invention. MPEP 2143.
Regarding the claimed compound, for example,
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the compound of formula I of Ishihara et al. reads on this when X is
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, m is 6, T5 is NHC(O), n is 1, p is 4, T3 is NHC(O), q is 0 and T4 is NHC(O). Rendering obvious claims 1-3 and 20.
Regarding claim 4-5, 10-11, when Z in Ishihara et al. is an oligonucleotide, this reads on macromolecule and corresponds to an R1 of H.
Regarding claim 9, oligonucleotides are SEQ ID NO: 1-3 which have 16 or 18 nt (claim 10). This results in a compound with a molecular weight above 3500 Daltons.
Regarding claim 13-15, F1 and F2 and be N-acetylgalactosamine reading on carbohydrate receptor ligand, an N-acylated amino monosaccharide, N-acetylgalactosaminyl.
Regarding claim 18, Y is taught as a leaving group. Leaving groups taught include diisopropylamino (column 4, lines 29-30; claim 6). Thus, the use of diisopropylamine in:
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gives the claimed group.
Regarding claim 23, Ishihara et al. claims a composition comprising the compound (claim 11). A carrier is also taught (claim 14).
Regarding claim 24, Ishihara et al. claims administering the compound (claim 13).
Regarding claim 25, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize instructions with the composition. “Where the printed matter is not functionally related to the substrate, the printed matter will not distinguish the invention from the prior art in terms of patentability.” In re Ngai, 367 F.3d 1336, 70 USPQ2d 1862 (Fed. Cir. 2004). See MPEP 2112.01. The applicant has not indicated that the instructions indicate some unobvious functional relationship between the product and the instructions.
Regarding claim 26, when the compound is, for example,
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when F1 and F2 and be N-acetylgalactosamine, m is 6, Z is oligonucleotide, T5 is NHC(O), n is 1, p is 4, T3 is NHC(O), T1 is (CH2)s wherein s is 4; q is 0 and T4 is NHC(O) and T2 is (CH2)u wherein u is 4.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Ishihara et al. (US 6057431) as applied to claims 1-5, 9-11, 13-15, 18, 20 and 23-26 above in view of Hong et al. (WO2022131883).
Applicant Claims
The instant application claims Z1 comprises at least one of SEQ ID NO: 1 (as elected). While Z1 lacks antecedent basis, the examiner interprets this as corresponding to an oligonucleotide attached to the compound.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
The teachings of Ishihara et al. are set forth above. Ishihara et al. teaches oligonucleotides can be attached. Ishihara et al. teaches that the composition can be used as an anti-viral agent, an anti-inflammatory, an immunosuppressive, a circulatory function improving agents, etc. (claim 12).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.02)
While Ishihara et al. teaches an oligonucleotide can be attached, Ishihara et al. does not expressly teach a sequence comprising SEQ ID No: 1. However, this deficiency is cured by Hong et al.
Hong et al. (machine translation provided) is directed to an RNAI Agent for inhibiting HBV expression and use thereof. Table 8 shows OLX700A-001-8 which is a sense strand of mG*fC*mAfGfUfAmUfGmUfUmGfAmUfGmGfA which is exactly the same as instantly claimed (see SEQ ID NO: 1 set forth in table 1 of the instant specification) and is taught as a negative control targeting the factor 9 gene (page 30).
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 Ishihara et al. and Hong et al. and utilize OLX700A-001-8 as the oligonucleotide. One skilled in the art would have been motivated to utilize this oligonucleotide as it is taught as targeting the factor 9 gene. Therefore, when desiring to target this gene, this is a useful oligonucleotide.
Claims 1-6, 8-11, 13-17 and 19-26 are rejected under 35 U.S.C. 103 as being unpatentable over Suckow et al. (WO2021108662) in view of Cabrele et al. (J. Med. Chem., 2014).
Applicant Claims
The instant claims are set forth above.
Specifically elected compound is:
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And more specifically
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Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
Suckow et al. is directed to compounds comprising a nucleic acid and a half-life extension motif. Claimed is a half-life extension motif covalently bound to a nucleic acid (claim 1). The nucleic acid is also covalently bonded to an uptake motif (claims 3-4). As claimed the uptake motif has the structure (IV):
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(claim 87). L3 is attached to the oligonucleotide can be an O (claim 87; 92-96).
An L4 specifically claimed is
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(claim 87).
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; R1 and R2 are unsubstituted alkyl, R3 include NHC(O) and substituted alkyl (claim 87).
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is a specific compound taught (Fig. 1A).
Uptake Domains taught include DTx-04-01
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(page 211). It is generally taught that the uptake modify independently includes one or more selected from a peptide, an antibody, a carbohydrate or an additional nucleic acid (page 225).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.02)
While Suckow et al. exemplifies a compound which is similar to the instantly claimed (and elected compound), Suckow et al. does not expressly teach a compound which contains a beta-lysine. However, this deficiency is cured by Cabrele et al.
Cabrele et al. is directed to peptides containing β-amino acid patterns: challenges and successes in medicinal chemistry. There are two major types of β-amino acid building blocks commonly used for bioactive peptides. The first type is based on homologues of natural α-amino acids that are extended by one methylene group incorporated adjacent to the carboxylate or amine functional groups (β2- or β3-analogue, respectively; Figure 1a). The major advantage of this variation is the generally straightforward synthesis of such building blocks with various side chains (in particular, those analogous to natural ones) (page 9718). Initial studies on the biological activity of β-amino acid-containing peptides focused on their interaction with biological membranes, and antimicrobial and cell-penetrating activities were evidenced (page 9720, left column).
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 Suckow et al. and Cabrele et al. and utilize a beta-lysine in combination with the L4 of claim 87 to form an uptake motif which can be utilized with an oligonucleotide. One skilled in the art would have been motivated to utilize a beta-lysine as Cabrele et al. teaches that beta-amino acids have cell-penetrating activities and that these amino acids are homologs of natural alpha-amino acids. Since Suckow et al. teaches alkylenes at this position there is a reasonable expectation of success. Furthermore, since this is used with the oligonucleotide as an uptake motif, which is to increase uptake of the oligonucleotide in the cell, there is motivation to utilize amino acids in the linker which would aid in uptake. Thus, the combination of beta-lysine and the L4 of claim 87 and O which is to connect to the oligonucleotide as taught by Suckow et al. would result in the elected species of claim 1-5, 10-11, 17, 19, 20, 21, 22 and 26.
Regarding claim 6, 13-15, 17, 21-22 and 26, Suckow et al. teaches uptake moieties can include carbohydrates and specifically exemplifies GalNAc (Fig. 10)., in the structure of the uptake motif as well as in exemplified uptake motifs, various lengths with NHC(O) being present in between alkylene chains. For example:
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. Thus, replacement of the lysine with beta-lysine for the reasons set forth above and replacement of the fatty chains with GalNAc would result in the elected compound.
Regarding claim 9, the exemplified compounds with oligonucleotides would result in the compound having a molecular weight of at least 3500 Da.
Regarding claim 16, Suckow et al. teaches that the term “pharmaceutically acceptable salts” refers to salts that retain the biological effectiveness and properties of a compound, which are not biologically or otherwise undesirable for use in a pharmaceutical. In many cases, the compounds herein are capable of forming acid and/or base salts by virtue of the presence of amino and/or carboxyl groups or groups similar thereto (paragraph 0084).
Regarding claim 23, Suckow et al. teaches a pharmaceutically composition comprising the compound and a pharmaceutically acceptable excipient (claim 190).
Regarding claim 24, Suckow et al. claims a method of introducing a nucleic acid into a cell within a subject comprising administering to the subject the compound (claim 188).
Regarding claim 25, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize instructions with the composition. “Where the printed matter is not functionally related to the substrate, the printed matter will not distinguish the invention from the prior art in terms of patentability.” In re Ngai, 367 F.3d 1336, 70 USPQ2d 1862 (Fed. Cir. 2004). See MPEP 2112.01. The applicant has not indicated that the instructions indicate some unobvious functional relationship between the product and the instructions.
Claims 7 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Suckow et al. (WO2021108662) in view of Cabrele et al. (J. Med. Chem., 2014) as applied to claims 1-6, 8-11, 13-17 and 19-26 above and in further view of Hong et al. (WO2022131883).
Applicant Claims
The instant application claims Z1 comprises at least one of SEQ ID NO: 1 (as elected). While Z1 lacks antecedent basis, the examiner interprets this as corresponding to an oligonucleotide attached to the compound.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
The teachings of Suckow are set forth above. Suckow et al. teaches oligonucleotides can be attached.
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.02)
While Suckow et al. teaches an oligonucleotide can be attached, Suckow et al. does not expressly teach a sequence comprising SEQ ID No: 1. However, this deficiency is cured by Hong et al.
Hong et al. is directed to an RNAI Agent for inhibiting HBV expression and use thereof. Table 8 shows OLX700A-001-8 which is a sense strand of mG*fC*mAfGfUfAmUfGmUfUmGfAmUfGmGfA which is exactly the same as instantly claimed (see SEQ ID NO: 1 set forth in table 1 of the instant specification) and is taught as a negative control targeting the factor 9 gene (page 30).
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 Suckow et al. and Hong et al. and utilize OLX700A-001-8 as the oligonucleotide. One skilled in the art would have been motivated to utilize this oligonucleotide as it is taught as targeting the factor 9 gene. Therefore, when desiring to target this gene, this is a useful oligonucleotide.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Neil Hammell can be reached on 571-270-5919. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ABIGAIL VANHORN/Primary Examiner, Art Unit 1636
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