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 GC-5 in the reply filed on May 5 2026 is acknowledged.
The elected species is free of prior art. The species election was initially expanded to compound G-G1-11 and G-G1-10 which is also free of prior art. Therefore, the species election was expanded to those compounds taught in Heyes et al. (USPGPUB No. 202000407724, see rejection below).
Claims 69-88 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 is a 371 of PCT/IB2022/000074 (02/18/2022) which claims benefit of 63/151,060 (02/18/2021) as reflected in the filing receipt issued on January 9 2026.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on May 5 2026 is 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 C.F.R. 1.84 states “Character of lines, numbers, and letters. All drawings must be made by a process which will give them satisfactory reproduction characteristics. Every line, number, and letter must be durable, clean, black (except for color drawings), sufficiently dense and dark, and uniformly thick and well-defined.”
In the current case, the words in Fig. 1, 2 (y-axis and title), 3, 6 (title; y-axis) and 7 are illegible.
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.
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 69-88 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.
"Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table ‘is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience.' Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993)" (MPEP 2173.05(s)). Therefore, claim 76 is indefinite as it refers to Table 9 in the specification. Applicants must copy the contents of the table into the claim.
Claim 69 as currently written is vague and indefinite. The claim recites in the definition of R128C, for example 9-1, which has the following structure:
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68
170
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which contains dotted lines at each end of the compound. It is not clear what the dotted/dashed lines are intended to mean. As evidenced by William Reusch (Chemistry.MSU.edu, 2013), when discussing the three dimensional shape or configuration of a molecule there are four types of bonds, normal, wedge, hatched and dashed bond. It is stated that some texts and other sources may use a dashed bond in the same manner as we have defined the hatched bond, but this can be confusing because the dashed bond is often used to represent a partial bond (i.e. a covalent bond that is partially formed or partially broken). Since the instant specification provides no explanation of what these bonds are intended to mean, the scope is unclear.
This issue continues to be confusing in claim 76. Claim 76 includes structure G-G1-09 which contains:
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121
234
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Claim 76 in the definition of Z’ includes for example 4-1:
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222
492
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. It is not clear what the dashed lined is attempting to indicate, it has to be more than just a point of attachment as the definition of 4-1 include P---O.
Therefore, the scope of the compounds in claim 76 (specifically definition of R128C); the compounds in claim 69; G-G1-09 and G-G1-10 in claim 76; the definition of Z’ in claim 76; claim 77; claim 73; claim 80; and claim 83 are indefinite.
The examiner notes that the branching groups recited in claim 69 include the wavy line. This is not indefinite as this is normal nomenclature indicating the point of attachment. Thus if the dashed line is intended to stand for the point of attachment, this type of bond notation would not be considered indefinite.
Claim 76 as currently written is vague and indefinite. While the structure of G-G1-10 is not indefinite. The claimed structure G-G1-09 includes Z’ whose scope is recited in Table 2. Looking to this structure C(O)-Z’ must correspond to J121. The examiner notes that n122 is 1. Looking to the scope of J121, claim 69 indicates that this a spacer being an alkylene of 1 to 10 carbon atoms where one or more carbon atoms are optionally replaced with one or more substituent selected from the group consisting of: C(O), NH, O, S, OP(O)O, OP(S)O, CH=N, S(O)2, and wherein the spacer is optionally substituted by at least one of C1-C5 alkyl or O-C1-C5 alkyl. Even if the species following optional are required, the species in, for example 4-15, which includes a total of (when m, n and p are 5) 36 carbon atoms (or replaced). This is significantly more than the 15 (10 carbon atoms of the alkylene and one of a C5 alkyl substitution). Therefore, it is unclear how this compound falls within the scope of the formula G-G1.
Claims 70-72, 74-75, 77-79, 81-82 and 84-88 are included in the rejection as they depend on a rejected base claim and they do not clarify the issues.
Claim Rejections - 35 USC § 112-Improper Markush
Claims 69-78 are rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of compounds of formula G-G1; G-G1-09 and G-G1-10 are improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons:
Firstly, looking at G-G1, the common structure of this compound is NH-CH-(CH2)n121-CH2 which is not a substantial structural feature because it is a very small portion of the entire compound and there is no indication that it is essential to the utility.
Looking to G-G1-09, the common structure of this compound is NH-CH(CO)-(CH2)n121-CH2 which is not a substantial structural feature because it is a very small portion of the entire compound and there is no indication that it is essential to the utility.
Looking to G-G1-10, the common structure is NH-CH(CH2O)-(CH2)n121-CH2 which is not a substantial structural feature because it is a very small portion of the entire compound and there is no indication that it is essential to the utility.
Claims 69-78 are directed to a genus of compounds that encompass a wide variety of chemical species which are in different physical classes and would embrace different chemical compound that do not share any single structural similarity between the species.
Looking to claim 69, the compounds in Table 9 contain two different groups of compounds (those with or without ethylene glycol groups), the branching groups include those with rings which would be classified differently than those with just acyclic groups. While R121 and R122 include compounds with O the claim also includes a lipid, a steroid, a polymer, a nucleotide which are all very different than an OH. Therefore these members of the Markush represent a plurality of chemical classes with varying structures.
Looking to claim 76, the various groups listed as choices for Z’ include those with a ring (and rings of varying sizes) as well as those with ethylene glycol groups and those without.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
Claim Rejections - 35 USC § 112-Scope of Enablement
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.
Claim 88 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for administering conjugates of the compounds with oligonucleotides or treating diseases associated with beta-catenin with an aiRNA comprising SEQ ID No: 1/3 and SEQ ID NO: 2 or treating HBV infection by way of the prior art, does not reasonably provide enablement for treating or preventing any disease or any condition in a subject in need thereof with any composition containing any compound of claim 69. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims. This is a scope of enablement rejection.
To be enabling, the specification of the patent must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993). Explaining what is meant by “undue experimentation,” the Federal Circuit has stated:
The test is not merely quantitative, since a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which the experimentation should proceed to enable the determination of how to practice a desired embodiment of the claimed invention. PPG v. Guardian, 75 F.3d 1558, 1564 (Fed. Cir. 1996).
The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth by In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 where the court set forth the eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Formal, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors:
1) the quantity of experimentation necessary,
2) the amount of direction or guidance provided,
3) the presence or absence of working examples,
4) the nature of the invention,
5) the state of the prior art,
6) the relative skill of those in the art,
7) the predictability of the art, and
8) the breadth of the claims.
These factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved. In re Fisher, 57 CCPA 1099, 1108, 427 F.2d 833, 839, 166 USPQ 18, 24 (1970). Keeping that in mind, the Wands factors are relevant to the instant fact situation for the following reasons:
The breadth of the claims and Nature of the Invention
Looking to the scope of claim 69, while oligonucleotides are options for R121 and R122, the claim does not require an oligonucleotide to be present. Even though the claim recites “and the oligonucleotide comprises naturally occurring and/or chemically modified nucleotides/nucleosides”, this limitation does not require the oligonucleotide to be present merely that when they are they are naturally occurring and/or chemically modified.
Thus, the BRI of the claim using any compound which may or may not contain any therapeutic portion (such as an oligonucleotide) to treat or prevent any disease or condition. Even if an oligonucleotide were required to be present, the BRI of the claim is that any disease or condition can be treated or prevented with any oligonucleotide.
The Relative Skill Level, the State of the Prior Art and The Level of
Predictability in the Art
The relative skill of those in the art is high, that of an MD or PHD someone with experience in pharmacy/pharmacology and drug design as well as medicine.
The Cleveland clinic provides a discussion on genetic disorders. These include chromosomal disorders like down syndrome, multifactorial disorders such as diabetes, monogenic disorders such as cystic fibrosis. Genetic disorder may also cause rare diseases. There may be as many as 7000 of these diseases such as adrenoleukodystrophy. Most genetic disorders do not have a cure. Some have treatments that may slow disease progression or lessen their impact on life (see whole document including overview; diagnosis and tests).
Hueso et al. is directed to non-coding RNAs (ncRNAs) in therapeutics: challenges and limitations in nucleic acid-based drug delivery. Barriers to translation of nucleic acid-based therapeutics into the clinic are related to stability, specificity, delivery and toxicity issues. There is a need for targeted therapies. Several investigations are being undertaken in animal models to test the effective delivery of oligonucleotides to their intracellular sites of action. Lack of efficient delivery remains one of the greatest challenges (conclusion). A strategy to prevent the harmful side effects cause by the delivery vehicle is to link targeting RNA to a ligand whose receptor is overexpressed in the cells of interest. This strategy is particular suited to target receptors overexpressed in cancerous cells. Conjugating ASOs to N-acetylglucosamine (GalNAc) binds to the high capacity ASGPR in the liver (section 5.2).
Zaidi et al. is directed to engineering siRNA therapeutics challenges and strategies. While siRNA are highly effective at post-transcriptionally suppressing the expression of desired target genes, their in vivo delivery faces significant obstacles such as off-target interactions, determining the optimal administration route, limited circulation half-life, inadequate endosomal escape into the cytosol, renal clearance, and immune evasion. Furthermore, siRNA’ intrinsic characteristics, specifically their potent anionic charge and exceptional hydrophilicity, also render them susceptible to systematic degradation within biological system (page 2).
Langtree provides a list of currently incurable diseases and conditions. This information provides a comprehensive overview of diseases currently considered incurable, spanning a wide range of conditions including infectious, non-infectious, neoplastic, autoimmune, genetic, and metabolic disorders. The list includes both terminal illnesses, such as late-stage cancer and AIDS, and chronic conditions like diabetes, asthma, and Alzheimer's disease, which can often be managed but not cured. Many incurable conditions, including diabetes, asthma, and Parkinson's disease, can be managed for a lifetime through therapy and daily care.
Langtree, therefore teaches, while many conditions can be treated or managed, prevention is not so widely considered as possible.
Thus, the state of the art establishes the difficulty with regards to delivering oligonucleotides and then their corresponding ability to treat disease. With regards to prevention, the state of the art establishes there are many diseases which are not known that can be prevented or cured.
The amount of direction or guidance provided and the presence or absence of working examples
Looking to the instant specification, examples 1-4 clearly show the synthesis of the compounds claimed, enabling one skilled in the art on how to make the compounds. Example 5 shows the conjugation of GC-05 with an oligonucleotide specifically a double stranded aiRNA with sense strand SEQ ID NO: 1 or 3 and antisense strand SEQ ID No: 2. This ex vivo delivery efficiency of the conjugate was tested in liver cells. Example 6 shoes what this aiRNA which is taught as a mβ-catenin aiRNA showed gene silencing activity in self-delivery ex vivo test at various concentrations and compared this to non-conjugated aiRNA showing that the conjugate provides great delivery. Example 7 shows culturing of two different conjugates showed gene silencing ex vivo. Example 8 shows he conjugates injected subcutaneously in mice. These results also show gene silencing similar to ex vivo data. Example 9 shows that ex vivo uptake and in vivo delivery of aiRNA 1 and aiRNA 2.
Therefore, the data in the specification shows two different aiRNA which can be delivered and provide gene silencing in the liver. However, none of this actually shows any treatment effective with this type of administration. Therefore, at best the specification shows that the conjugates can be administered and provide uptake into the liver and diseases associated with β-catenin the corresponding gene could be silenced. But not the full breadth of the claims which include delivery any compound claimed which may not include an oligonucleotide to treat any disease or disorder including those in which delivery to the liver would not be beneficial.
The quantity of experimentation necessary
Because of the known unpredictability of the art with regards to prevention as well as treatment over the full scope of the claims, and in the absence of experimental evidence, no one skilled in the art would accept the assertion that the instantly claimed agents could be predictably used to treat or prevent the full scope of diseases or conditions as inferred by the claim and contemplated by the specification. Accordingly, the instant claims do not comply with the enablement requirement of §112, since to practice the invention claimed in the patent a person of ordinary skill in the art would have to engage in undue experimentation, with no assurance of success.
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 69-75 and 84-88 are rejected under 35 U.S.C. 103 as being unpatentable over Heyes et al. (USPGPUB No. 20200407724).
Applicant Claims
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
Heyes et al. is directed to targeted compositions. As claimed is a compound of formula (I)
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310
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wherein R1 is a targeting ligand, L1 is absent or a linking group, L2 is absent or a linking group, R2 is a double stranded siRNA and A can be absent (claim 7).
A specific compound claimed is of formula (Ia):
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1297
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wherein A and L2 can be absent and R2 is a nucleic acid (claim 175).
Other targeting ligands taught include:
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943
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(paragraph 0283).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.02)
While Heyes et al. teaches compounds formula Ia which when A and L2 are absent read on the instant claims, Heyes et al. does not expressly exemplify this compound.
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 formulate a compound of formula 1a wherein A and L2 are absent. One skilled in the art would have been motivated to select L2 is absent as it is one of two options for L2. One skilled in the art would have been motivated to select ring A is absent as it is one of 5 options. Therefore, all that is required to arrive at the claimed invention is simple selection of known options from a finite list. Note: MPEP 2143.
Regarding the claimed structure: this portion of the compound:
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reads on n121 of 1 (reading on claim 74) and R123-126 of H. Regarding J122-R121 when A is absent and L2 is absent and R2 is a nucleic acid this reads on J122 of alkylene of 10 carbons where two are replaced with C(O). Heyes et al. teaches the siRNA are attached to the remainder of the compound through the oxygen of a phosphate at the 3’ end of the sense strand (paragraph 0497). This results R121 of being a phosphate-oligonucleotide. Regarding R127: which is J123A-R128A and results in J123A of C(O), R128A is R128B-R128L wherein R128B is alkylene wherein the carbon atoms are replaced with NH, C(O) and C6 arylene with the rest of the molecule on that side (left hand) being a ligand capable of docking to a cell surface receptor. Regarding J121-R122, looking to the top portion of the molecule, this reads on J121 being 5 carbons which are replaced with C(O), NH and R122 corresponding to either a polymer or a PEG group (the instant specification contains no limiting definition of these groups therefore any compound which contains as its part a polymer or PEG necessarily reads on these groups).
Regarding claim 70, firstly this claim does not require R128C to be present just that when it is present it is selected from those groups. Even if the group was required to be present the difference between formula 1a and the instant claims is that the instantly claimed R128C is a homolog (i.e. it has two less carbon atoms than the first species recited in claim 70). An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties. In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979). MPEP 2144.09.
Regarding claim 71, firstly a branching group is not required and this claim does not require a branching group to be present merely that these are the species of branching group. The structure of Heyes et al. contains the same branching group (top row, third compound).
Regarding claim 72, the compound of Heyes et al. includes GalNAc.
Regarding claim 73, the compound teaches a O-CH2-CH2-O group linking the GalNAc to the branching moiety.
Regarding claim 76, replacement of the targeting ligand on formula 1a with the other targeting ligands taught would result in n121L of 3.
Regarding claim 84, Heyes et al. teaches the siRNA are attached to the remainder of the compound through the oxygen of a phosphate at the 3’ end of the sense strand (paragraph 0497).
Regarding claims 85-86, Heyes et al. teaches the siRNA may be about 19-25 (duplex) nucleotides in length. The can have a 3’ overhang of about 1 to 4 nucleotides with a sense and antisense strand (paragraph 0027). In some embodiments the 5’ and/or the 3’ contains an overhang on one or both strands of 1-4 modified and/or unmodified nucleotides (paragraph 0028)
Regarding claim 87, Heyes et al. teaches a pharmaceutical composition comprising a compound of formula I and a pharmaceutically acceptable carrier (paragraph 0263).
Regarding claim 88, Heyes et al. teaches the compound of formula I for the therapeutic treatment of hepatitis B virus infection in an animal (paragraph 0193; paragraph 0018; 0265, example 25).
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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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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