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 .
This Official Action considers the response filed 11/03/2025. The amendments and arguments presented therein are sufficient to overcome the rejections under 35 U.S.C. 103 as being obvious over Byrne et al (US20120322861) and Guild et al (US2015366997) and further in view of An et al (Molecular Genetics and metabolism, Vol.85:247-254, 2005). The Double Patenting rejections of record are maintained.
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.
Claims 1, 2, 5, 9, 10, 12, 15, 17, 24, 29, 33, 42-44, 47, 48, 70-87, 90, and 91 is/are rejected under 35 U.S.C. 103 as being obvious over Byrne et al (US20120322861) and Guild et al (US2015366997) and further in view of An et al (Molecular Genetics and metabolism, Vol.85:247-254, 2005).
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 11, 2, 5, 9, 10, 12, 15, 17, 24, 29, 33, 42-44, 47, 48, and 70-92 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 10,172,924 in view of Guild et al (US2015366997). Although the claims at issue are not identical, they are not patentably distinct from each other because both the application and patent claims are drawn to the treatment of Pompe disease via GAA expressing mRNA liposomal combinations including optimized GAA sequences. While the patent does not specifically teach a reduction in glycogen levels in the liver it is indeed an effect of systemic GAA expression in a therapy for Pompe disease. Guild et al have taught the liposome combinations of the instant invention for delivering mRNA therapeutics and have taught to utilize this technology in treating Pompe disease via GAA encoding mRNA. At paragraph 5, for example, it is taught that mRNA-based therapy provides advantages to prior art techniques of gene therapy. Throughout it has been taught various combinations of cationic lipid, non-cationic, cholesterol, PEGylated combinations for mRNA delivery where it was within the skill of one in the art to determine optimal combinations for effective delivery. It has also been taught various dosages and treatment regimens where it was within the skill of one in the art the time of filing to optimize dosages and treatment regimes. It has also been taught that mRNA therapeutics can comprise modified nucleotides. At paragraph 108 it has been taught “The compositions of the invention may be prepared to preferentially distribute to target cells such as in the heart, lungs, kidneys, liver and spleen. In some embodiments, the compositions of the invention distribute into the cells of the liver to facilitate the delivery and the subsequent expression of the mRNA comprised therein by the cells of the liver (e.g., hepatocytes). The targeted hepatocytes may function as a biological “reservoir” or “depot” capable of producing, and systemically excreting a functional protein or enzyme. Accordingly, in one embodiment of the invention the liposomal transfer vehicle may target hepatocytes and/or preferentially distribute to the cells of the liver upon delivery. Following transfection of the target hepatocytes, the mRNA loaded in the liposomal vehicle are translated and a functional protein product is produced, excreted and systemically distributed. In other embodiments, cells other than hepatocytes (e.g., lung, spleen, heart, ocular, or cells of the central nervous system) can serve as a depot location for protein production.”
Claims 1, 2, 5, 9, 10, 12, 15, 17, 24, 29, 33, 42-44, 47, 48, and 70-92 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,090,368 in view of Guild et al (US2015366997). Although the claims at issue are not identical, they are not patentably distinct from each other because both the application and patent claims are drawn to the treatment of Pompe disease via GAA expressing mRNA liposomal combinations including optimized GAA sequences. While the patent claims do not specifically teach a reduction in glycogen levels in the liver it is indeed an effect of systemic GAA expression in a therapy for Pompe disease. Guild et al have taught the liposome combinations of the instant invention for delivering mRNA therapeutics and have taught to utilize this technology in treating Pompe disease via GAA encoding mRNA. At paragraph 5, for example, it is taught that mRNA-based therapy provides advantages to prior art techniques of gene therapy. Throughout it has been taught various combinations of cationic lipid, non-cationic, cholesterol, PEGylated combinations for mRNA delivery where it was within the skill of one in the art to determine optimal combinations for effective delivery. It has also been taught various dosages and treatment regimens where it was within the skill of one in the art the time of filing to optimize dosages and treatment regimes. It has also been taught that mRNA therapeutics can comprise modified nucleotides. At paragraph 108 it has been taught “The compositions of the invention may be prepared to preferentially distribute to target cells such as in the heart, lungs, kidneys, liver and spleen. In some embodiments, the compositions of the invention distribute into the cells of the liver to facilitate the delivery and the subsequent expression of the mRNA comprised therein by the cells of the liver (e.g., hepatocytes). The targeted hepatocytes may function as a biological “reservoir” or “depot” capable of producing, and systemically excreting a functional protein or enzyme. Accordingly, in one embodiment of the invention the liposomal transfer vehicle may target hepatocytes and/or preferentially distribute to the cells of the liver upon delivery. Following transfection of the target hepatocytes, the mRNA loaded in the liposomal vehicle are translated and a functional protein product is produced, excreted and systemically distributed. In other embodiments, cells other than hepatocytes (e.g., lung, spleen, heart, ocular, or cells of the central nervous system) can serve as a depot location for protein production.”
Claims 1, 2, 5, 9, 10, 12, 15, 17, 24, 29, 33, 42-44, 47, 48, and 70-92 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,712,463 in view of Guild et al (US2015366997). Although the claims at issue are not identical, they are not patentably distinct from each other because both the application and patent claims are drawn to the treatment of Pompe disease via GAA expressing mRNA liposomal combinations including optimized GAA sequences. While the patent claims do not specifically teach a reduction in glycogen levels in the liver it is indeed an effect of systemic GAA expression in a therapy for Pompe disease. Guild et al have taught the liposome combinations of the instant invention for delivering mRNA therapeutics and have taught to utilize this technology in treating Pompe disease via GAA encoding mRNA. At paragraph 5, for example, it is taught that mRNA-based therapy provides advantages to prior art techniques of gene therapy. Throughout it has been taught various combinations of cationic lipid, non-cationic, cholesterol, PEGylated combinations for mRNA delivery where it was within the skill of one in the art to determine optimal combinations for effective delivery. It has also been taught various dosages and treatment regimens where it was within the skill of one in the art the time of filing to optimize dosages and treatment regimes. It has also been taught that mRNA therapeutics can comprise modified nucleotides. At paragraph 108 it has been taught “The compositions of the invention may be prepared to preferentially distribute to target cells such as in the heart, lungs, kidneys, liver and spleen. In some embodiments, the compositions of the invention distribute into the cells of the liver to facilitate the delivery and the subsequent expression of the mRNA comprised therein by the cells of the liver (e.g., hepatocytes). The targeted hepatocytes may function as a biological “reservoir” or “depot” capable of producing, and systemically excreting a functional protein or enzyme. Accordingly, in one embodiment of the invention the liposomal transfer vehicle may target hepatocytes and/or preferentially distribute to the cells of the liver upon delivery. Following transfection of the target hepatocytes, the mRNA loaded in the liposomal vehicle are translated and a functional protein product is produced, excreted and systemically distributed. In other embodiments, cells other than hepatocytes (e.g., lung, spleen, heart, ocular, or cells of the central nervous system) can serve as a depot location for protein production.”
Applicant has offered no arguments in regard to the Double Patenting rejections above.
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 SEAN MCGARRY whose telephone number is (571)272-0761. The examiner can normally be reached M-Th/F 9:00-7:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ram Shukla can be reached at 571 272 1600. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SEAN MCGARRY/Primary Examiner, Art Unit 1635