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 .
Status of Application
The Preliminary Amendment filed on 08/30/24 is acknowledged.
Claims 1, 3, 8-10, 12, 14-15, 19, 21, 23-24, 27, and 30 were cancelled.
Claims 2, 4-7, 13, 16-17, 20, 22, 25-26, 28-29, and 31-34 were amended.
Claims 2, 4-7, 11, 13, 16-18, 20, 22, 25-26, 28-29, and 31-34 are pending and included in the prosecution.
Information Disclosure Statement
The information disclosure statements (IDS) filed on 09/03/24 and 01/30/25 are acknowledged. The submissions are in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the examiner is considering the information disclosure statements. Please see the attached copies of PTO-1449.
Double Patenting
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 2, 4-7, 11, 13, 16-18, 20, 22, 25-26, 28-29, and 31-34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,737,979 B2 (“the ‘979 Patent”).
Although the conflicting claims are not identical, they are not patentably distinct from each other because they are drawn to a method of producing a lipid-encapsulated RNA nanoparticle, and therefore, encompass overlapping or coextensive subject matter.
One difference is that claim 1 of the ‘979 Patent recites an inner diameter (ID) of a first tube of between about 0.1” and 0.132” and an ID of a 2nd tube of between about 0.005” and 0.02”, whereas instant claim 2 does not recite this limitation.
However, instant claim 11 recites that the 1st tube has an ID in a range from about 0.01 inches to about 0.08 inches and the 2nd tube has an ID in a range from about 0.01 inches to about 0.04 inches. The upper limit of the 0.08 inches of the ID of the 1st tube as recited in instant claim 11 overlaps the lower limit of about 0.1” as recited in claim 1 of the ‘979 Patent. The range of about 0.01 inches to about 0.04 inches of the ID of the 2nd tube as recited in instant claim 11 overlaps the range of between about 0.005” and 0.02” as recited in claim 1 of the ‘979 Patent, thereby rendering it obvious. According to MPEP 2144.05, “In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists.”
Another difference is that instant claim 2 recites that the mixing comprises flowing the ethanol solution and the aqueous solution into a mixing module consisting of the 2nd tube perpendicularly joined to the 1st tube, whereas claim 1 of the ‘979 Patent does not recite this limitation. However, claim 8 of the ‘979 Patent recites that the mixing module is made of stainless steel and consists of the 2nd tube mounted perpendicularly on the 1st tube, thereby rendering this limitation obvious.
Therefore, instant claims are obvious over claims of the ‘979 Patent and they are not patentably distinct over each other.
Claims 2, 4-7, 11, 13, 16-18, 20, 22, 25-26, 28-29, and 31-34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,938,227 B2 (“the ‘227 Patent”).
Although the conflicting claims are not identical, they are not patentably distinct from each other because they are drawn to a method of producing a lipid-encapsulated RNA nanoparticle, and therefore, encompass overlapping or coextensive subject matter.
One difference is that claim 1 of the ‘227 Patent recites an inner diameter (ID) of a first tube of between about 0.01 inches to about 0.08 inches and an ID of a 2nd tube of about 0.01 inches to about 0.04 inches, whereas instant claim 2 does not recite this limitation.
However, instant claim 11 recites that the 1st tube has an ID in a range from about 0.01 inches to about 0.08 inches and the 2nd tube has an ID in a range from about 0.01 inches to about 0.04 inches, which are the same ranges as in claim 1 of the ‘227 Patent.
Another difference is that instant claim 2 recites that the mixing comprises flowing the ethanol solution and the aqueous solution into a mixing module consisting of the 2nd tube perpendicularly joined to the 1st tube, whereas claim 1 of the ‘227 Patent does not recite this limitation. However, claim 3 of the ‘227 Patent recites a mixing module consisting of the 2nd tube perpendicularly joined to the 1st tube, thereby rendering this limitation obvious.
Therefore, instant claims are obvious over claims of the ‘227 Patent and they are not patentably distinct over each other.
Pertinent Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: (i) Knopov et al. (US 2017/0152516 A1 – “Knopov”); (ii) Nechev et al. (US 2016/0243255 A1 – “Nechev”); and (iii) Yaworski et al. (US 2016/0032320 A1 – “Yaworski”) are the closest prior art references.
Knopov teaches a method for preparing a lipid nanoparticle encapsulating a RNA molecule comprising steps (a) – (d) wherein step (b) includes injecting a lipid solution comprising a cationic lipid, a helper lipid, a sterol, and a PEG lipid dissolved in a water-miscible organic solvent into the aqueous solution in the mixing container at a constant rate for 1-100 minutes while stirring the aqueous solution until a mixture comprising 25-45% (v:v) organic solvent is reached (claims 1-23).
Nechev teaches a method of preparing a formulation comprising lipid nanoparticles comprising an RNAi agent payload comprising steps (a) – (b), wherein step (a) includes mixing a first solution with a second solution in a mixing connector, wherein (i) said first solution comprises an ethanolic solution comprising one or more lipids and having a total lipid concentration of approximately 30 mg/mL, and (ii) said second solution comprises citrate buffered aqueous solution comprising one or more RNAi agents and having an RNAi agent concentration of approximately 1 mg/mL and a pH of between 3 and 6 (claims 1-10 and 27-28).
Yaworski teaches methods of making lipid particles comprising a nucleic acid such as one or more interfering RNA using direct dilution (Abstract, FIG. 1A, [0162]).
However, Knopov, Nechev, and Yaworski do not teach or suggest a method of producing a lipid-encapsulated RNA nanoparticle comprising steps a) – c) as recited in the instant claims.
Conclusion
No claims are allowed.
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/ARADHANA SASAN/Primary Examiner, Art Unit 1615