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 . 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.
Claim Objections
Claim 58 is objected to because of the following informalities: Claim 58 at the first line recites the phrase “of any”, which should be deleted. Appropriate correction is required.
Claim Rejections - 35 USC § 112 – Indefiniteness
and Broad Limitation followed by Narrow Limitation
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 59 and 69 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.
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 59 recites the broad recitation “ICE”, and the claim also recites “(Imidazol-based)” which is the narrower statement of the range/limitation.
In the present instance, claims 59 and 69 recite the broad recitation “3-(4-(bis(2- hydroxydodecyl)amino)butyl)-6-(4-((2-hydroxydodecyl)(2- hydroxyundecyl)amino)butyl)-1,4-dioxane-2,5-dione”, and the claim also recites “(Target 23)” which is the narrower statement of the range/limitation.
In the present instance, claims 59 and 69 recite the broad recitation “3-(5-(bis(2- hydroxydodecyl)amino)pentan-2-yl)-6-(5-((2-hydroxydodecyl)(2- hydroxyundecyl)amino)pentan-2-yl)-1,4-dioxane-2,5-dione”, and the claim also recites “(Target 24)” 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.
The Applicant is encouraged to remove the parentheses from the claims, at each instance of occurrence.
Claim Rejections - 35 USC § 103 - Obviousness
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.
Claim(s) 46-48, 53-59 and 65-70 are rejected under 35 U.S.C. 103 as being unpatentable over Huang et al (US 2018/0311343A1), in view of Heartlein et al (US 2015/0140070 A1).
Huang taught a pharmaceutical composition [0037] for treating cancer [claim 131]. The composition comprised one or more mRNA encapsulated in a lipid nanoparticle [1299, 1482], wherein the mRNA encoded for an antigen (e.g., PD-1 [0425, 0521-0522]) of interest (Ag) and a polypeptide that enhanced an immune response to the antigen of interest (e.g., immune potentiator (IP), e.g., STING polypeptide (e.g., an immune potentiator)) [1300]. The lipid nanoparticles generally comprised a cationic lipid [0613, 0665, 1272]. Additionally, mRNA encoding for IL-12 (e.g., immune potentiator) was taught as an additional agent, used in combination with Huang [0520].
The disclosure provided compositions that comprised combinations of two or more immune potentiator mRNAs (e.g., Huang provided for the encapsulation of STING, IL-12) [0202], wherein each mRNA was formulated in the same, or different, lipid nanoparticle [E179, ¶ 1410; E239-241, 1447].
Although Huang generally taught cationic lipids, Huang was silent cKK-E12, as recited claim 46.
Nevertheless, Heartlein taught liposome (e.g., nanoparticles taught at [0073]) formulations incorporating exemplary cationic lipids, for example cKK-E12. cKK-E12 effectively delivered and expressed mRNA-encoding therapeutic proteins in vivo [0481]. Heartlein demonstrated that cKK-E12 is uniquely useful in delivering mRNA, for highly efficient and sustained production of protein (e.g., therapeutic protein) in vivo. cKK-E12 permits an improved mRNA therapy that significantly reduced required amounts of mRNA and associated lipids, administration frequency, and possible side effects, thereby providing more potent, safer, and patient friendly mRNA therapy for various diseases (e.g., cancers taught at Table 4) [0004, 0501].
Since Huang generally taught cationic lipids incorporated into nanoparticles, for the delivery of mRNA, it would have been prima facie obvious to one of ordinary skill in the art to include, within the teachings of Huang, cKK-E12, as taught by Heartlein. An ordinarily skilled artisan would have been so motivated, for the effective delivery and expression of mRNA-encoding therapeutic proteins in vivo, as taught by Heartlein [0481]. This is because cKK-E12 permits an improved mRNA therapy that significantly reduces required amounts of mRNA and associated lipids, administration frequency, and side effects, thereby providing more potent, safer, and patient friendly mRNA therapy for various diseases, as taught by Heartlein [0004, 0501].
Huang, in view of Heartlein, reads on claims 46-48, 56 and 65-70.
Claims 53-54 are rendered prima facie obvious because Huang taught the mutant form of STING; STING as constitutively active [0239-0249].
Claim 55 is rendered prima facie obvious because Heartlein disclosed mRNA encoding proteins listed in Table 1, of which serum albumin is a listed protein [0426; see also Table 1]. The motivation to combine Heartlein with Huang was previously described.
Claims 57-59 are rendered prima facie obvious because Huang taught cholesterol, PEG-DMG [0051] and DLin-DMA [0651].
Claim(s) 49-52 are rejected under 35 U.S.C. 103 as being unpatentable over Huang et al (US 2018/0311343A1), in view of Heartlein et al (US 2015/0140070 A1) and further in view, of Besin et al (US 2019/0314291 A1).
The 35 U.S.C. 103 rejection over Huang and Heartlein was previously discussed.
Additionally, Huang taught mRNA encoding FLT3 [0299], IL-2 [0121, 0185, 1609-1611] and NLPR3 [0292, 0296, 1665].
Huang did not teach mRNA encoding GM-CSF, as recited in claims 49-52.
Besin taught a lipid nanoparticle formulated into a pharmaceutical composition, encapsulating a single nucleic acid or multiple nucleic acids, further formulated into the same or separate pharmaceutical compositions. For example, the same or separate pharmaceutical compositions comprised a first LNP and a second LNP, wherein the first and second LNP encapsulated the same or different nucleic acid molecules [1613]. The LNPs comprised CKK-E12 [1878]. Besin taught a combination of GM-CSF IL-2 and IL-12 ([E131, [1647]), wherein mRNA that encoded for GM-CSF [1549] stimulated white blood cell production, to enhance anti-tumor T cells [1449].
Since Huang generally taught treating cancer, it would have been prima facie obvious to one of ordinary skill in the art to include, within the teachings of Huang, mRNA encoding GM-CSF, as taught by Besin. The ordinarily skilled artisan would have been so motivated, because GM-CSF stimulates white blood cell production, to enhance anti-tumor T cells, as taught by Besin [1449, 1549].
Conclusion
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/CELESTE A RONEY/Primary Examiner, Art Unit 1612
