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 .
Applicant’s amendment and argument of 5/26/26 is entered.
Claims 1, 4-5, 7, and 15 are amended.
Claims 2-3, 6, 16, and 20 are canceled.
Claims 1, 4-5, 7-15, 17, and 19 are pending and considered herein.
Claim Status, Canceled Claims
In light of the cancelation of Claims 2-3, 6, 16, and 20, all rejections/objections thereto, are withdrawn.
Claim Objections
In light of the amendment to Claim 15, the advisory that should claim 1 be found allowable, claim 15 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof, is withdrawn.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.
NSDP rejections were considered for U.S. Patent No. 10,182,988, however, they were not determined proper. To wit, the present claims require the oligonucleotide to be a TLR9 agonist, while the patent, at best, is to oligonucleotides that act as antisense, hybridizing to the coding sequence of a nucleotide. Thus, these claims have distinct scopes.
Claims 1, 4-5, 7-15, 17, and 19 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,792,251. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claim 1: Claim 1 of the patent teaches a plurality of liposomes, being substantially spherical, and comprising a lipid bilayer and about 10-40 oligonucleotides on the external side of the bilayer, each being a TLR9 agonist, and conjugated to the surface by way of a lipophilic tethered group, the liposomal particles being less than or equal to 40nm. Claims 1 and 12 recite about 40nm, which is less than the claimed 45nm.
Claim 4: e.g., Claims 1 and 12 teach about 40, which is more than 5 nm and less than 45 nm.
Claim 5: e.g., Claims 1 and 12 teach about 40, which is more than 10 nm and less than 45 nm.
Claim 7: e.g., Claims 1 and 12 teach about 40, which is between 20 and 45 nm.
Claim 8: e.g., Claims 1 and 12 teach 10-40 oligonucleotides.
Claim 9: e.g., Claims 1 and 12 teach 10-40 oligonucleotides.
Claim 10: e.g., Claims 1 and 12 teach 10-40 oligonucleotides.
Claim 11: e.g., Claims 1 and 12 teach 10-40 oligonucleotides, which is about 50 oligonucleotides.
Claim 12: e.g., Claims 11 and 20 teach 3’ end conjugation.
Claim 13: e.g., Claims 4 and 13 teach tocopherol or cholesterol.
Claim 14: e.g., Claims 1 and 12 teach single-stranded.
Claim 15: e.g., Claims 6-7 and 15-16 teach CpG containing oligos, and Claims 7 and 15 teach SEQ ID NO: 8.
Claim 17: Claims 1 and 12 teach less than or equal to about 40 nm, Claims 9-10 and 18-19 teach less than or equal to 35 and 30 nm, respectively.
Claim 19: Claims 1 and 12 teach about 10-40 oligonucleotides.
Thus, in light of the patent, the invention is obvious. The Artisan would make it, and expect success, as it is claimed.
Response to Argument – NSDP, US PAT NO 10,792,251
Applicant’s argument of 5/26/26 has been considered but is not found persuasive.
Applicant argues that they have filed attestation that the patent and the present Application are subject to a joint research agreement under 35 USC 102(b)(2)(C), and thus, the rejection should be withdrawn (p. 6, paragraph 6).
Such is not persuasive. 102(b)(2)(C) has to do with prior art rejections, and the disclosure used in non-statutory double patenting rejections. However, in the present case, the claimed subject matter is infringing, and no reliance has been had of the disclosure.
For Applicant’s edification though, the 102(b)(2)(C) exception does make them eligible to file a terminal disclaimer. From MPEP 717.02(c):
Commonly owned applications of different inventive entities may be rejected on the ground of double patenting, even if the later filed application claims 35 U.S.C. 120 benefit to the earlier application, subject to the conditions discussed in MPEP § 804 et seq. In addition, double patenting rejection may arise as a result of the joint research agreement exception. Congress recognized that deeming a joint research agreement as common ownership would result in situations in which there would be double patenting rejections between applications not owned by the same party (see H.R. Rep. No. 108-425, at 5-6 (2003)). For purposes of double patenting analysis, the U.S. application or patent and the subject matter excepted under 35 U.S.C. 102(b)(2)(C) and 35 U.S.C. 102(c) will be treated as if commonly owned.
(emphasis added).
Thus, Applicant can now file a terminal disclaimer.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
In light of the amendment and argument, the rejections of Claim(s) 1, 4-5, and 7-15 under 35 U.S.C. 102(a)(2) as being anticipated by both of U.S. Patent Application No. 2011/0159081 (the Application Publication) and U.S. Patent No. 8,846,080, (the Patent), both evolving from the Biemans Application No. 13/060,301, filed 8/26/2009, are withdrawn.
To wit, Applicant has amended the base claim to less than 45 nm, and the prosecution of the patent demonstrates that there are errors in the ranges discussed by Bieman that make it impossible to ascertain that ranges below 45 were disclosed, as argued by Applicant (Argument 5/26/26, pp. 7-10).
.
Claim Rejections - 35 USC § 103
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 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.
In light of the base art falling under 102, the rejections of Claim(s) 1, 4-5, 7-15, and 17 under 35 U.S.C. 103 as being unpatentable over both of U.S. Patent Application No. 2011/0159081 (the Application Publication) and U.S. Patent No. 8,846,080, (the Patent), both evolving from the Biemans Application No. 13/060,301, filed 8/26/2009, coupled with Chan, et al. (2009) “Effects of linker sequences on vesicle fusion mediated by lipid-anchored DNA oligonucleotides”, Proceedings of the National Academy of Sciences, USA, 106(4): 979-84, also are withdrawn.
Conclusion
No claim is 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 ROBERT M KELLY whose telephone number is (571)272-0729. The examiner can normally be reached M-F: 8a-5p.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Tracy Vivlemore can be reached at 571-272-2914. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
ROBERT M. KELLY
Examiner
Art Unit 1638
/ROBERT M KELLY/Primary Examiner, Art Unit 1638
Prosecution Insights