DETAILED ACTION
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 .
Claims 52-65 are pending.
Information Disclosure Statement
The IDS has been considered.
The Spec. cites references.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Claim Interpretation
Claim 52 recites a compound having the following structure, [structure] OF-02, or a salt thereof. OF-02 is interpreted as the name of the structure shown in the claim.
Claim 64 recites OF-02, wherein the PEGylated lipid comprises a poly(ethylene) glycol chain of up to 5 kDa in length covalently attached to a lipid with alkyl chain(s) of C6-C20 length. That claim can be interpreted to mean that the PEGylated lipid is attached to a lipid with alkyl chains of C6-20 length (i.e., “having”: the PEGylated lipid is attached to a lipid that has alkyl chains of C6-20 length) or that the PEGylated lipid is attached to a lipid via alkyl chains of C6-20 length (i.e., the PEGylated lipid is attached to a lipid via alkyl chains of C6-20 length). The claim is broadly interpreted as encompassing either of these interpretations.
Claim Objections
Claim 57 is objected to because of the following informalities: Claim 57 recites viral satellite RNA twice, once in L4-5 and once in the last line. Applicant should remove one instance.
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 60-64 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.
The term “antigenic” in Claim 60 is a relative term which renders the claim indefinite. The term “antigenic” 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. What is or is not an antigen varies from individual to individual.
Claim 60 is rejected for those reasons. Claims 61-62 are rejected because they depend from Claim 60 and do not remedy the issues.
In the interest of compact prosecution, any substance that that can be encoded by a polynucleotide is considered potentially antigenic.
The term “derived from a virus” in Claim 61 is a relative term which renders the claim indefinite. The term “derived from a virus” 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. What is considered “derived from a virus” does not have one single definition. There is no set amount of how much a substance can vary before it is no longer considered to have been “derived from” something. Similarly, there is no set amount of how much a substance must have in common with the substance from which it is “derived” for the substance to be considered to have been “derived from” something. Therefore, whether or not a protein or peptide is considered to be “derived from” a virus varies depending on the eye of the beholder.
Claim 61 is rejected for those reasons. Claim 62 is rejected because it depends from Claim 61 and does not remedy the issues.
In the interest of compact prosecution, a protein or peptide that is “derived from a virus” is interpreted as a protein or peptide encoded by a native (i.e., not recombinant or genetically engineered) virus genome.
A broad limitation together with a narrow range or limitation that falls within the broad 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 63 recites the broad recitation wherein the protein or peptide is an… active protein, and the claim also recites wherein the protein or peptide is an enzyme, structural protein, receptor, soluble receptor, ion channel, … cytokine, interleukin, antibody, antibody fragment, antigen, coagulation factor, albumin, growth factor, hormone, or insulin which is the narrower statement of the 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. An “active protein” is understood to mean any protein with activity but the claim also recites that the protein or peptide is among those on a list of proteins/peptides that are recited to have function: an enzyme, structural protein, receptor, soluble receptor, ion channel, … cytokine, interleukin, antibody, antibody fragment, antigen, coagulation factor, albumin, growth factor, hormone, or insulin. Therefore the metes and bounds of the claim are unclear.
In the interest of compact prosecution, the claims are interpreted to encompass any active protein (i.e., any protein possessing any function).
Claim 64 recites the limitation "a lipid with alkyl chains of C6-20 length " in L2. There is insufficient antecedent basis for this limitation in the claim because the claim recites more than one lipid and it’s not clear if a lipid is one of the lipids already recited or a further lipid. That information is necessary to ascertain the structure of the claimed compound. Claim 53 (whence claim 64 depends) recites a PEGylated lipid, a phospholipid, and cholesterol (which an artisan would instantly recognize is one species of lipid). Then Claim 64 recites properties of the PEGylated lipid (it comprises a PEG chain of up to 5 kDa in length) and that it is attached to a lipid with alkyl chains of C6-20 length. It is not clear whether a lipid with alkyl chains of C6-20 length is one of the lipids already recited or if it’s a further lipid.
Claim 64 is indefinite for that reason. In the interest of compact prosecution the claim is interpreted as meaning the PEGylated lipid is attached to a further lipid.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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) 52-65 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by International Patent Application Publication No. WO 2013/063468 (published 02 May 2013, “WO468”, of record on IDS) as evidenced by Avanti Research (Product pages for 18:0 PEG1000 PE, product No. 880720 and 14:0 PEG2000 PE, product No. 880150. Available online at avantiresearch.com. Accessed on 09 February 2026. “Avanti”).
WO468 describes (¶5):
compositions characterized, in certain embodiments, by conjugation of various groups, such as lipophilic groups, to an amino or amide group of an amino acid, a linear or cyclic peptide, a linear or cyclic polypeptide, or structural isomer thereof, to provide compounds of the present invention, collectively referred to herein as “APPLs”. Such APPLs are deemed useful for a variety of applications, such as, for example, improved nucleotide delivery.
WO468 teaches (¶6, § starting on p. 230, point 1) Formula (III):
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wherein p is 1-9; R1 or R2 can be H, or R1 or R2 can be optionally substituted alkenyl, optionally substituted alkynyl, or -N(RA1)2 wherein each RA1 can be optionally substituted alkenyl, optionally substituted alkynyl; or can be Formula (iv) (shown here in a modified excerpt of WO468):
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Furthermore, WO468 teaches (¶29) “alkenyl” can comprise 2-40 C atoms and comprises one or more C–C double bonds. WO468 teaches (¶348) RL is defined as C6-50 alkyl or C6-50 alkenyl groups that encompass lipophilic groups or “lipid tails” and that lipid tails present in those lipid groups can be saturated or unsaturated. WO468 teaches (¶349-354) RL can be optionally substituted. WO468 teaches (¶272) Formula (III-c3) wherein q can be 4:
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Those teachings indicate that it was routine and conventional to produce compounds of Formula (III) and substitute or mix/match various components for any chosen purpose. WO468 teaches (¶16) their invention encompasses the APPL or a salt thereof. Therefore WO468 teaches compounds that encompass the structure of OF-02 and therefore anticipates Claim 52.
Regarding limitations of Claims 53, 64, and 65: WO468 teaches (¶18) the composition can comprise an agent that is a polynucleotide (polynt) which can be DNA or RNA, and that the RNA can be RNAi, dsRNA, or miRNA. WO468 teaches (¶17) a composition comprising the APPL can be a pharmaceutical composition. WO468 describes components of compositions (starts at ¶369) and teaches they can comprise various components including: (¶374) cholesterol, (¶391) a phospholipid that can be DSPC, DOPC, DPPC, and others recited in instant Claim 65; and (¶392) a polymer including PEG and PEGylated lipids such as PEG stearate, 1,2-Distearoyl-sn-glycero-3-Phosphoethanolamine-N-[Methoxy(Polyethylene glycol)-1000], or others. Therefore WO468 anticipates Claims 53 and 65. Regarding Claim 64, Avanti provides evidence that 1,2-Distearoyl-sn-glycero-3-Phosphoethanolamine-N-[Methoxy(Polyethylene glycol)-1000] inherently meets those claim limitations. Avanti shows that the PEG chain of 1,2-Distearoyl-sn-glycero-3-Phosphoethanolamine-N-[Methoxy(Polyethylene glycol)-1000] is covalently attached to a lipid with alkyl chains of C6-20 length. The structure of 1,2-Distearoyl-sn-glycero-3-Phosphoethanolamine-N-[Methoxy(Polyethylene glycol)-1000] is shown here:
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.
Furthermore, Avanti discloses that the formula weight of 1,2-Distearoyl-sn-glycero-3-Phosphoethanolamine-N-[Methoxy(Polyethylene glycol)-1000] is 1792.31 which is less than 5 kDa. The teachings of Avanti indicate that 1,2-Distearoyl-sn-glycero-3-Phosphoethanolamine-N-[Methoxy(Polyethylene glycol)-1000] inherently possesses the properties described in instant Claim 64. Therefore by teaching their composition can comprise 1,2-Distearoyl-sn-glycero-3-Phosphoethanolamine-N-[Methoxy(Polyethylene glycol)-1000], WO468 anticipates the limitations of Claim 64.
Regarding Claims 56-63: WO468 teaches (¶424-426) the polynt can comprise any sequence and can encode a protein (including enzymes, structural proteins, receptors, antibodies, or others) or peptide, or (¶425) can encode an antigen, including (¶426) an antigen derived from influenza A or B or respiratory syncytial virus. Therefore WO468 anticipates Claims 56-63.
Regarding Claims 54-55: WO468 teaches (¶421) the polynt may be modified by chemical or biological means and ¶422) such modifications can be in bases, sugars, and/or phosphate linkages. Therefore WO468 teaches the limitations of Claims 54-55.
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, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 52-65 are rejected under 35 U.S.C. 103 as being unpatentable over International Patent Application Publication No. WO 2013/063468 (published 02 May 2013, “WO468”, of record on IDS) as evidenced by Avanti Research (Product pages for 18:0 PEG1000 PE, product No. 880720 and 14:0 PEG2000 PE, product No. 880150. Available online at avantiresearch.com. Accessed on 09 February 2026. “Avanti”) as applied to Claims 52-65 in the 102 rejection above, and further in view of WO468.
The teachings of WO468 as applied to Claims 52-65 have been described in the 102 rejection above.
WO468 teaches all the limitations of Claims 52-65.
WO468 does not explicitly teach the exact compound shown in Claim 52.
However, WO468 teaches compounds comprising Formula (III) and teaches all the various components can include variations that would have produced the exact formula shown in Claim 52. WO468 teaches (¶29, ¶348) lipids of their Formula (III) can include double bonds and be saturated or unsaturated. Those teachings indicate that WO468 envisioned compounds comprising all the possible components taught in WO468, including double bonds/unsaturated lipids. That means that Formula OF-02 is merely an obvious variant of what is encompassed by the full teachings of WO468.
As noted in In re Aller, 105 USPQ 233 at 235, more particularly, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. MPEP 2144.05 provides: It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions (In re Williams, 36 F.2d 436, 438 (CCPA 1929).
Here, the focus is that general conditions are known in the prior art and changes in form or, possibly, substitution of equivalents, over the prior art that does the same thing as what is known in the prior art is not patentable. Here, WO468 presented various equivalents that are suitable for use in their Formula (III). None of the components in claimed formula OF-02 deviate from what is taught in WO468. Furthermore, the teachings of WO468 indicate it was routine and conventional to combine, in various combinations, the components taught by WO468. Therefore the teachings of WO468 indicate that substitution of equivalents in terms of identifying optimal locations and proportions of different chemical groups, to produce optimal or improved results, is known in the prior art. Therefore the compounds of Claims 52-65 must be deemed obvious in view of WO468.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claim 52 is rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 24 of prior U.S. Patent No. 10201618. This is a statutory double patenting rejection.
Claims 52 is rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 20-21 of prior U.S. Patent No. 10695444. This is a statutory double patenting rejection.
Claim 52-53 and 64-65 are rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 18 and 21-22 of prior U.S. Patent No. 11679165. This is a statutory double patenting rejection.
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 52-65 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, and 6-26 of U.S. Patent No. 10201618 (“US618”) and further in view of International Patent Application Publication No. WO 2013/063468 (published 02 May 2013, “WO468”, of record on IDS) as evidenced by Avanti Research (Product pages for 18:0 PEG1000 PE, product No. 880720 and 14:0 PEG2000 PE, product No. 880150. Available online at avantiresearch.com. Accessed on 09 February 2026. “Avanti”).
Although the claims at issue are not identical, they are directed to overlapping subject matter because the instant claims are directed to a compound having the structure of OF-02 (or a salt thereof), a pharmaceutical composition comprising the compound, a polynt (which can be modified), a PEGylated lipid, a phospholipid, and cholesterol; wherein the polynt can be RNA (or various species of RNA) or can be DNA; wherein the polynt can encode any protein or peptide (including any active protein or a list of proteins recited in Claim 63) or any antigen, wherein the antigen can be derived from a virus or certain species of virus; wherein the PEGylated lipid can comprise various properties recited in Claim 64, and wherein the phospholipid can be one of various species recited in Claim 65.
The patented US618 claims are directed to compounds of Formula (I) wherein R’ is H, x is 6, z is 1, and y is 4; or wherein the compound is OF-02 (US618 Claim 24); to a composition comprising the compound or a salt thereof, wherein the composition can comprise cholesterol, a PEGylated lipid, or a phospholipid; wherein the agent can be a polynucleotide or nucleic acid; wherein the agent is a polynt that can be RNA (or various species of RNA) or can be DNA; to methods of delivering the agent to a subject or cell; and to methods of preparing the compounds.
Both claim sets are directed to or encompass the compound having the structure OF-02, and US618 directly claims the exact same structure, as shown in this excerpt of US618 Claim 24:
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The patented claims don’t recite that the protein is an antigen, of viral origin (or certain species of virus), that the protein is active, or the PEGylated lipid comprises a PEG chain of up to 5kDa, or the phospholipid is selected from the group recited in instant Claim 65.
However, WO468, drawn to amino acid derivates functionalized on the N-terminus capable of forming drug encapsulating microspheres, teaches (¶18, ¶416-426) their derivatives can be used to encapsulate a polynt that can be various species of RNA or DNA, and that the polynt can encode a protein or peptide, that the protein/peptide can be an antigen (that can be derived from an influenza A or B virus or the respiratory syncytial virus) or can be an enzyme, receptor, or other species of protein. WO468 teaches (¶421-422) the polynt can comprise modifications. WO468 teaches (¶391) their composition can comprise various species of phospholipid and/or it can comprise a polymer, including PEGylated lipids (e.g., PEG-stearate or 1,2-Distearoyl-sn-glycero-3-Phosphoethanolamine-N-[Methoxy(Polyethylene glycol)-1000]…). Avanti research shows a picture of the latter compound which shows it is attached to a lipid with alkyl chains of C6-20 length:
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Avanti teaches that compound’s molecular weight is 1792.31 which is less than 5 kDa.
It would have been obvious to an artisan to modify the US618 claims with the teachings of WO468 as evidenced by Avanti for the benefits of optimizing the delivery capability of the compound. It would have been obvious to do so and the artisan would have had a reasonable expectation of success because WO468 demonstrates that all of the species and variants in the instant claims were known alternatives and that it was routine and conventional to use any of them, so it would have been obvious to swap any of them during routine optimization.
Therefore the instant claims would have been obvious in view of the patented US618 claims and WO468.
Claims 52-65 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 10695444 (“US444”) and further in view of WO468 and evidence of Avanti.
Although the claims at issue are not identical, they are directed to overlapping subject matter because the instant claims are directed to a compound having the structure of OF-02 (or a salt thereof), a pharmaceutical composition comprising the compound, a polynt (which can be modified), a PEGylated lipid, a phospholipid, and cholesterol; wherein the polynt can be RNA (or various species of RNA) or can be DNA; wherein the polynt can encode any protein or peptide (including any active protein or a list of proteins recited in Claim 63) or any antigen, wherein the antigen can be derived from a virus or certain species of virus; wherein the PEGylated lipid can comprise various properties recited in Claim 64, and wherein the phospholipid can be one of various species recited in Claim 65.
The patented US444 claims are directed to compounds of Formula (I) wherein each instance of RL is independently optionally substituted C6-C40 alkenyl comprising only cis double bonds; or wherein the compound is OF-02 (US444 Claims 20-21) and can comprise mRNA; to a composition comprising the compound or a salt thereof, wherein the composition can comprise cholesterol, PEG or a PEGylated lipid that can be 1,2-dimyristoyl-sn-glycero-3-phosphoethanolamine-N-[methoxy(polyethyleneglycol)-2000] (C14-PEG 2000, Avanti) (US444 Claim 7), and/or a phospholipid (including various species of phospholipid, US444 Claim 6); wherein the agent can be a polynucleotide or nucleic acid; wherein the agent is a polynt that can be RNA (or various species of RNA) or can be DNA.
Both claim sets are directed to or encompass the compound having the structure OF-02, and US444 directly claims the exact same structure, as shown in this excerpt of US444 Claims 20-21:
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The patented claims don’t recite that the protein is an antigen, of viral origin (or certain species of virus), or that the protein is active, or that the recited PEGylated lipid is less than 5kDa.
However, WO468, drawn to amino acid derivates functionalized on the N-terminus capable of forming drug encapsulating microspheres, teaches (¶18, ¶416-426) their derivatives can be used to encapsulate a polynt that can be various species of RNA or DNA, and that the polynt can encode a protein or peptide, that the protein/peptide can be an antigen (that can be derived from an influenza A or B virus or the respiratory syncytial virus) or can be an enzyme, receptor, or other species of protein. WO468 teaches (¶421-422) the polynt can comprise modifications. Avanti research shows a picture of the US444 claimed compound 1,2-dimyristoyl-sn-glycero-3-phosphoethanolamine-N-[methoxy(polyethyleneglycol)-2000] which shows it is attached to a lipid with alkyl chains of C6-20 length. Avanti teaches that compound’s molecular weight is 2693.32 which is less than 5 kDa.
It would have been obvious to an artisan to modify the US444 claims with the teachings of WO468 as evidenced by Avanti for the benefits of optimizing the delivery capability of the compound. It would have been obvious to do so and the artisan would have had a reasonable expectation of success because WO468 demonstrates that all of the species and variants in the instant claims were known alternatives and that it was routine and conventional to use any of them, so it would have been obvious to swap any of them during routine optimization.
Therefore the instant claims would have been obvious in view of the patented US444 claims and WO468.
Claims 52-65 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. 11679165 (“US165”).
Although the claims at issue are not identical, they are not patentably distinct because the instant claims are directed to a compound having the structure of OF-02 (or a salt thereof), a pharmaceutical composition comprising the compound, a polynt (which can be modified), a PEGylated lipid, a phospholipid, and cholesterol; wherein the polynt can be RNA (or various species of RNA) or can be DNA; wherein the polynt can encode any protein or peptide (including any active protein or a list of proteins recited in Claim 63) or any antigen, wherein the antigen can be derived from a virus or certain species of virus; wherein the PEGylated lipid can comprise various properties recited in Claim 64, and wherein the phospholipid can be one of various species recited in Claim 65.
The patented US165 claims are directed to a composition comprising a polynt, a PEGylated lipid, a phospholipid, a cholesterol, and compounds of Formula (I) wherein each instance of RL is independently optionally substituted C6-C40 alkenyl comprising only cis double bonds; wherein the composition can comprise a PEGylated lipid that can be 1,2-dimyristoyl-sn-glycero-3-phosphoethanolamine-N-[methoxy(polyethyleneglycol)-2000] (C14-PEG 2000) (US165 Claim 12), and/or a phospholipid (including various species of phospholipid, US165 Claim 14); wherein the compound is OF-02 or a salt thereof (US165 Claims 18, 21-22) and wherein the composition comprises DSPC, cholesterol, and C14-PEG-2000; wherein the polynt can be RNA (or various species of RNA) or can be DNA. US165 claims recite that (US165 Claims 7-10) the polynt encodes a protein or peptide that can be an antigen which can be derived from influenza A, B, or the respiratory syncytial virus. As described in §Claim interpretation, the term “antigen” encompasses literally any protein or peptide because any protein/peptide can be an antigen for an individual. US165 claims recite that the polynt can be chemically modified.
Both claim sets are directed to or encompass the compound having the structure OF-02, and US165 directly claims the exact same structure, as shown in this excerpt of US165 Claims 18 and 21-22:
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Therefore the instant claims would have been obvious in view of the patented US165 claims.
Claims 52-65 are rejected on the ground of nonstatutory double patenting as being unpatentable over the following claims of the following patents, and further in view of WO468 and evidence of Avanti.
Patent
Claims
US 9629804 (“US804”)
1, 3-10, 12-18
US 9512073 (“US073”)
1-33
Although the claims at issue are not identical, they are directed to overlapping subject matter because the instant claims are directed to a compound having the structure of OF-02 (or a salt thereof), a pharmaceutical composition comprising the compound, a polynt (which can be modified), a PEGylated lipid, a phospholipid, and cholesterol; wherein the polynt can be RNA (or various species of RNA) or can be DNA; wherein the polynt can encode any protein or peptide (including any active protein or a list of proteins recited in Claim 63) or any antigen, wherein the antigen can be derived from a virus or certain species of virus; wherein the PEGylated lipid can comprise various properties recited in Claim 64, and wherein the phospholipid can be one of various species recited in Claim 65.
The patented US804 claims are directed to compositions or methods of delivering mRNA comprising administering to a subject a composition comprising mRNA encoding CFTR encapsulated by a liposome that comprises compounds of Formula (I-c) (US804) or compounds comprising Formula (III) (US073), wherein the compound comprises various options for each variable. Those options include optionally substituted alkenyl and others that read on the instant claims.
An artisan might not know what US804 considers an alkenyl so they would consult the Spec. and find (Col 59-60 L4-47) that term encompasses hydrocarbons comprising C–C double bonds. An artisan might not know what US073 considers an alkenyl so they would consult the Spec. and find (Col 9 L45) that term encompasses hydrocarbons comprising C–C double bonds.
All claim sets are directed to or encompass the compound having the structure OF-02.
The patented claims don’t recite every limitation of the instant claims, including that the protein is an antigen, of viral origin (or certain species of virus), or that the protein is active, or that the recited PEGylated lipid is less than 5kDa.
However, WO468, drawn to amino acid derivates functionalized on the N-terminus capable of forming drug encapsulating microspheres, teaches the same compounds as the patented or allowed claims and teaches (¶5-6; § starting on p. 230, point 1; ¶29, ¶348, ¶349-354, ¶272, ¶16, ¶18, ¶17; § starts at ¶369; ¶374, ¶391-392, ¶424-426, ¶421, ¶422) variations of them that read on the instant claims. WO468 also teaches (¶18, ¶416-426) their compounds can be used to encapsulate a polynt that can be various species of RNA or DNA, and that the polynt can encode a protein or peptide, that the protein/peptide can be an antigen (that can be derived from an influenza A or B virus or the respiratory syncytial virus) or can be an enzyme, receptor, or other species of protein. WO468 teaches (¶421-422) the polynt can comprise modifications. WO468 teaches (¶391) their composition can comprise various species of phospholipid and/or it can comprise a polymer, including PEGylated lipids (e.g., PEG-stearate or 1,2-Distearoyl-sn-glycero-3-Phosphoethanolamine-N-[Methoxy(Polyethylene glycol)-1000]…). Avanti research shows a picture of the latter compound which shows it is attached to a lipid with alkyl chains of C6-20 length. Avanti teaches that compound’s molecular weight is 1792.31 which is less than 5 kDa.
It would have been obvious to an artisan to modify the patented claims with the teachings of WO468 as evidenced by Avanti for the benefits of optimizing the delivery capability of the compound. It would have been obvious to do so and the artisan would have had a reasonable expectation of success because WO468 demonstrates that all of the species and variants in the instant claims were known alternatives and that it was routine and conventional to use any of them, so it would have been obvious to swap any of them during routine optimization.
Therefore the instant claims would have been obvious in view of the patented claims and WO468.
Conclusion
Claims 52-65 are rejected.
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RUTHIE S ARIETI
Examiner (Ruth.Arieti@uspto.gov)
Art Unit 1635
/RUTH SOPHIA ARIETI/Examiner, Art Unit 1635
/NANCY J LEITH/Primary Examiner, Art Unit 1636