DETAILED ACTION
Claims 1-10 are pending.
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/CN2022/125877 10/18/2022 which claims FOR priority to CHINA 202111222428.7 (10/20/2021).
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
None provided.
Drawings
The drawings are objected to for the following reasons:
There is no label (i.e. no figure identification) on the third figure, 5th figure, 7th figure and 9th figure.
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 Figure 1A, 1B, 2A, 2B, 2C, 2D, 4, 6, 7, 8, 9A-9E are illegible.
37 CFR 1.84 (u)(1) states “View numbers must be preceded by the abbreviation "FIG."” In the current case, the view numbers for many figures 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
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 - Sequences appearing in the specification are not identified by sequence identifiers (i.e., “SEQ ID NO:X” or the like) in accordance with 37 CFR 1.831(c). Specifically, sequences in Tables 13-17 contain more than 10 specifically enumerated nucleotides but do not contain sequence identifiers.
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 sequence identifiers, 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.
Specific deficiency – Nucleotide and/or amino acid sequences appearing in the drawings are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). Sequence identifiers for nucleotide and/or amino acid sequences must appear either in the drawings or in the Brief Description of the Drawings. See Fig. 9A-9E.
Required response – Applicant must provide:
Replacement and annotated drawings in accordance with 37 CFR 1.121(d) inserting the required sequence identifiers;
AND/OR
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers into the Brief Description of the Drawings, 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.
Specification
The disclosure is objected to because of the following informalities: table 2 (starting page 26) is not legible. Looking to the PGPUB the table shows ? where the table is not legible. Same with Tables 3, 4, 5, 8, 9, 10, 11 and 12. The structures in paragraph 000161-000165, 000202-000205, 000303-000306, page 76-89, page 162-182, page 200-201 and 203-208 are not clear.
Applicants are encouraged to look at the PGPUB. Everywhere the structures are not legible the PGPUB indicates a (?) which indicates text missing or illegible when filed.
Appropriate correction is required.
Claim Objections
Claim 1 is objected to because of the following informalities: The acronym “AGT” is not defined in the claims. When an acronym is used in a claim set, it should be defined the first time it appears in the claims. For the purposes of examination, the term “AGT” is interpreted to mean angiotensinogen. Appropriate correction is required.
Claim 7 is objected to because of the following informalities: a conjunction is missing before the last species in the claim. Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 10 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because “Use” claims that do not purport to claim a process, machine, manufacture, or composition of matter fail to comply with 35 U.S.C. 101. In re Moreton, 288 F.2d 708, 709, 129 USPQ 227, 228 (CCPA 1961); In Ex parte Dunki, 153 USPQ 678 (Bd. App. 1967); In Clinical Products Ltd. v. Brenner, 255 F. Supp. 131, 149 USPQ 475 (D.D.C. 1966). Note MPEP 2173.05(q)
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 1-10 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 as currently written is vague and indefinite. Claim 1 refers to formula IIIa, IIIb and IIIc which all show the presence of a 5’MVIP and a 3’MVIP. However, claim 1 states that the carrier structure includes a 5’MVIP and/or a 3’MVIP which indicates that both are not required to be present. This creates uncertainty as to the scope of the claim.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 2 recites the broad recitation an integer of 2 to 6, and the claim also recites preferably n+m=2,3 or 5, more preferably 4 which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
"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 3 is indefinite as it refers to Tables 10 and 11 in the specification and claim 8 refers to Table 18. Applicants must copy the contents of the table into the claim.
The term “essentially homologous” in claim 4 is a relative term which renders the claim indefinite. The term “essentially homologous” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The claim recites in the alterative that the sequence can different from any of the recited sequences by no more than 3 nucleotides. This recitation is not indefinite. But neither the claims nor the specification indicate the metes and bounds of the term “essentially homologous” and how it compared to the recitation “by no more than 3 nucleotides”.
Claim 7 as currently written is vague and indefinite. The claim refers to interfering nucleic acids by codes. However, these structures are not clear in the specification. Since the structures are not clear in the specification this creates uncertainty to the instant scope. Applicants must recite the specific structure of these interfering nucleic acids to avoid indefiniteness.
Claim 8 as currently written is vague and indefinite. The claim refers to sequences in the specification which appear to have specific conjugates attached. However, for example, Table 12 serial # 2 and 6 provide different definitions for the same compound. Therefore, claim 8 must recite the specific structure and sequence of the RNAi agent to avoid indefiniteness, since it does not appear that the SEQ ID NO corresponding to the sequences in these compounds is clearly set forth in the tables.
Claim 10 as currently written is vague and indefinite. While the claim provides for the "use" of the RNAi agent or pharmaceutically acceptable salt thereof, the claims do not set forth any steps involved in the method/process, and thus it is unclear what method/process they are intending to encompass. A claim is indefinite where it merely recites a use without any active, positive steps delimiting how this use is actually practiced. Note: MPEP 2173.05(q).
Claim 9 is included in the rejection as they depend on a rejected base claim and they do not clarify the issues.
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 10 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 the compounds or treating diseases associated with overexpression of AGT such as hypertension, does not reasonably provide enablement for treating or preventing any disease or any condition or to reduce the risk of a disease or condition. 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 claim 10, while the claim is indefinite for the reasons set forth above, it appears the claim has the intended use of prevent and/or treat a disease or condition or to reduce the risk of a disease or condition, the enablement of compositions limited by a particular use must be considered. See In re Vaeck, 947 F.2d 488, 20 USPQ2d 1438 (Fed. Cir. 1991) and In re Gardner, 427 F.2d 786, 166 USPQ 138 (C.C.P.A. 1970). Note: MPEP 2164.01(c).
Therefore, the claim is very broad in that it encompasses preventing or treating any disease or condition or reducing the risk of any disease or condition with an siRNA which targets AGT gene.
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, clearly teaches a variety of siRNA which can be used to target the AGT gene and that administration reduces the average level of AGT in serum (see examples and Fig. 8; table 19).
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 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over Foster et al. (USPGPUB No. 20170189541) in view of Lu et al. (CN110846320A).
Applicant Claims
The instant application claims an RNAi agent comprising a carrier structure and an interfering nucleic acid in its structure as shown in formula IIIa, IIIb or IIIc or a pharmaceutically acceptable salt thereof wherein the interfering nucleic acid targets an AGT gene which includes antisense strand and sense strand.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
Foster et al. is directed to angiotensinogen (AGT) iRNA compositions and methods of use thereof. Claimed is a double-stranded ribonucleic acid (RNAi) agent for inhibiting expression of angiotensinogen (AGT) in a cell wherein said double-stranded RNAi agent comprises a sense strand and an antisense strand forming a double-stranded region and wherein said sense strand is conjugated to a ligand attached at the 3’-terminus (claim 1). Sense and Antisense strand sequences of AGT dsRNAs (21/21 mer) are shown in Table 7. One specific duplex is:
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76
747
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45
717
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75
649
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52
661
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The ligand is one or more GalNAc derivatives attached through a bivalent or trivalent branched linker (paragraph 0041).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.02)
While Foster et al. teaches a nucleic acid which targets an AGT gene and can include a ligand attached, Foster et al. does not teach a 5’MVIP and/or a 3’MVIP. However, this deficiency is cured by Lu et al.
Lu et al. (wherein USPGPUB No. 20230374513 is serving as an English language equivalent and all paragraph numbers) is directed to novel compound and application thereof. Taught are compounds comprising an interfering nucleic acid, transition points and delivery chains of the interfering nucleic acid. By means of the delivery chains, such siRNA can be introduced with two to three N-acetylgalactosamines at the 3’ end of the antisense strand and correspondingly, two to one N-acetylgalactosamines at the 5’ end of the sense strand with the total number of the introduced N-acetylgalactosamines being four (paragraph 0003). It is taught that siRNA is labile in blood and tissues and prone to be degraded by nucleases. To improve the stability of siRNA, the skeleton of siRNA can be modified. However, these chemical modifications only provide limited protection from nuclease degradation and may eventually affect the activity of siRNA. Therefore, a delivery system is further needed to ensure that siRNA can cross cell membranes efficiently. Because siRNA has a large molecular mass with a large amount of negative charges and a high solubility in water, they cannot cross the cell membranes to get into the cells (paragraph 0008). It is taught that the compounds allow for a completely new manner for introduction of N-acetylgalactosamine (paragraph 0060-0061).
As claimed the compound has the formula (I) (claim 1):
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272
467
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wherein R1 is -NH(CH2)xCH2- wherein x may be an integer of 3-10 and R2 is -NHCH2(OH)CH2(OH) (claim 1). Delivery chains taught include 5’Y1Cd-01 and 5’ERcd-01 (paragraph 0050).
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 Foster et al. and Lu et al. and utilize the compounds of Lu et al. as ligands with the siRNA of Foster et al. One skilled in the art would have been motivated to utilize the compounds of Lu et al. as they are new GalNAc ligands which allow for introduction at both the 5’ and 3’ ends to efficient deliver siRNA. Since Foster et al. teaches the use of a GalNAc ligand and Lu et al. teaches these ligands allow for efficient delivery, one skilled in the art would have a reasonable expectation in substituting the GalNAc ligand taught in Foster et al. with the ligand taught in Lu et al. as this is simple substitution of one known ligand with another. Since Lu et al. teaches the use of the ligands with siRNA there is a reasonable expectation of success.
Regarding claim 2, Lu et al. teaches that the combination of n and m is preferably 4 (claim 1).
Regarding the sequences recited in claims 4-6, SEQ ID NO: 511 has 100% identity to instantly claimed SEQ ID NO: 8 and 44 shown below:
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418
709
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429
738
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And SEQ ID NO: 549 has 100% identity to instantly claimed SEQ ID No: 26 and 62:
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446
709
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438
707
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Regarding claim 7, the above identified sequences correspond to Kylo-09-DS08.
Regarding claims 3 and 8, Lu et al. teaches delivery chains of 5’Y1Cd-01 and 5’ERcd-01 (paragraph 0050), which when combined with R1 and R2 result in instant 5’MV1Po1 and 3’MV1P03 or 5’MV1P09 and 3’MV1PO1 as indicated in the drawings to the best of the ability of the examiner since the figures are not clear. Since the sequence of these compounds is not clear, it isn’t clear to the examiner if modifications are required. However, if modifications of the nucleic acids is required Foster et al. teaches modifications which include 2’-O-methyl., 2’-fluoro, etc. (see claims) as well as phosphorothioate (paragraph 0044). Lu et al. also teaches modifications (see paragraph 0024-0025). 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 Foster et al. and Lu et al. and utilize known chemical modifications. One skilled in the art would have been motivated to utilize modifications to improve stability of the siRNA as taught by Foster et al. and Lu et al.
Regarding claim 9-10, Foster et al. Teaches pharmaceutical compositions and formulations which include the iRNAs. These include a pharmaceutically acceptable carrier (paragraph 0470).
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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