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 Amendments and Remarks filed on 05/08/26 are acknowledged.
Claims 1, 3, 8-10, 12, 14-15, 19, 21, 23-24, 27, and 30 were previously cancelled.
Claims 2, 5-6, 13, 17, 20, 22, 26, and 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.
Response to Amendments/Arguments
Nonstatutory double patenting rejection over US Patent No. 11,737,979 B2
Applicant amended claims 2, 5, and 13 to recite that in step (c), mixing the ethanol solution with the aqueous solution results in a total flow rate of 80 ml/min to 200 ml/min. In light of this amendment, Applicant’s arguments (Pages 7-8, filed 05/08/26) with respect to the rejection of claims 2, 4-7, 11, 13, 16-18, 20, 22, 25-26, 28-29, and 31-34 on the ground of nonstatutory double patenting (NSDP) as being unpatentable over claims 1-19 of U.S. Patent No. 11,737,979 B2 (“the ‘979 Patent”) have been fully considered and are persuasive. In addition to the claim amendment, Applicant’s arguments regarding the large RNA molecules recited in the instant claims versus the claims of the ‘979 Patent which neither require nor contemplate RNA lengths; and the surprising finding that a lower flow rate worked better for large RNA encapsulate formulations versus increasing the flow rate in the ‘979 Patent were persuasive. Therefore, the NSDP rejection over the ‘979 Patent is withdrawn.
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 again 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.
Response to Arguments
Applicant’s arguments (Pages 8-9, filed 05/08/26) with respect to the rejection of claims 2, 4-7, 11, 13, 16-18, 20, 22, 25-26, 28-29, and 31-34 on the ground of NSDP as being unpatentable over claims 1-20 of U.S. Patent No. 11,938,227 B2 (“the ‘227 Patent”) have been fully considered but are not persuasive.
Applicant argues that the amended claims recite a specific flow rate when mixing the ethanol and aqueous solutions that is not claimed by the ‘227 Patent.
This is not persuasive because even thought the specific flow rate when mixing the ethanol and aqueous solutions is not claimed by the ‘227 Patent, claim 3 of the ‘227 Patent recites “… wherein the mixing comprises flowing the ethanol solution and the aqueous solution into a mixing module …” One of ordinary skill in the art would have found it obvious to use the mixing step recited in claim 3 of the ‘227 Patent and use a flow rate that provides adequate mixing, rendering the flow rate recited in instant claims 2, 5, and 13 obvious.
The Examiner acknowledges Applicant’s statement that they are willing to consider filing a terminal disclaimer (TD) over the ‘227 Patent once an allowable claim set has been agreed upon. Until such time that a TD over the ‘227 Patent is filed the NSDP rejection over this patent will be maintained for the reasons provided above.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARADHANA SASAN whose telephone number is (571)272-9022. The examiner can normally be reached Monday to Friday from 6:30 am to 3:00 pm.
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/ARADHANA SASAN/Primary Examiner, Art Unit 1615
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