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 .
Claims 1-6, 11, 14, 16-18, and 20-28 are pending and currently under consideration.
Claim Rejections - 35 USC § 112
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 1-6, 11, 14, 16-18, and 20-28 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.
Claims 1-6, 11, 14, 16-18, and 20-28 are rejected because claim 1 recites an antibody wherein CDR-H2 is a sequence selected from a group comprising SEQ ID NO: 13 and CDR-L2 is a sequence selected from a group comprising SEQ ID NO: 5. The metes-and-bounds of the claims are unclear because the specification does not disclose sequences of SEQ ID NO: 13 or SEQ ID NO: 5.
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 1-6, 11, 14, 16-18, and 20-27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 and 23-28 of copending Application No. 18/706057 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are directed to methods of administering complexes to subjects with DMD and the copending claims are directed to the same complexes and methods of administering the complexes to subjects with DMD. The instant claims differ from the copending claims in that the instant claims recite dosages of the complexes to be administered and instant claims recite the subjects are “human” (see claim 22). However, the copending specification discloses subjects of the copending methods include human subjects ([00044], in particular). Therefore, copending methods include methods wherein the subject are human subjects. Further, the copending specification discloses administration of such complexes at a dose of 122 mg/kg a week apart (Example 2, in particular). In regards to doses and dosing schedules recited by the instant claims, it would be conventional and routine for one to perform the copending methods using various dosages and dosing schedules, including those encompassed by the claims, in order to optimized the copending method. “[W]here the general conditions of a claims are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456 (CCPA 1955) (Citing In re Dreyfus, 73 F.2d 931 (CCPA 1934); In re Waite, 168 F.2d 104 (CCPA 1948)). MPEP 2144.05 states: “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical.” In the instant case, given the known function of the recited complexes to treat DMD, it is well within the level of the ordinary skilled artisan to adjust the dosages and timing of administration for optimal therapeutic efficacy and safety, and to arrive at the dosages and timing of administration instantly claimed, where the administration of the complexes is expected to provide therapeutic treatment to subjects with DMD.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-6, 11, 14, 16-18, and 20-28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 28-55 of copending Application No. 18/896790 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are directed to methods of administering complexes to subjects with DMD and the copending claims are directed to the same complexes and methods of administering the complexes to subjects with DMD. The instant claims differ from the copending claims in that the instant claims recite linkers that link the PMO to the antibody (claims 2-3), the instant claims recite dosages of the complexes to be administered, the instant claims recite PMO is linked to the antibody at a lysine or cysteine (claims 27-28), and instant claims recite the subjects are “human” (see claim 22). However, the copending specification discloses subjects of the copending methods include human subjects ([00076], in particular). Further, the copending specification discloses PMO of the copending claims is linked to antibody of the copending claims by linkers of instant claims 1-2 (copending [00043] and [00047]) and that such linkages occur at cysteine or lysine residues of the antibody ([00081]). Therefore, copending methods include methods wherein the subject are human subjects and the PMO is linked to the antibody of the copending claims in the same manner as recited by instant claims. Further, the copending specification discloses administration of such complexes at a dose of 122 mg/kg a week apart (Example 2, in particular). In regards to doses and dosing schedules recited by the instant claims, it would be conventional and routine for one to perform the copending methods using various dosages and dosing schedules, including those encompassed by the claims, in order to optimized the copending method. “[W]here the general conditions of a claims are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456 (CCPA 1955) (Citing In re Dreyfus, 73 F.2d 931 (CCPA 1934); In re Waite, 168 F.2d 104 (CCPA 1948)). MPEP 2144.05 states: “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical.” In the instant case, given the known function of the recited complexes to treat DMD, it is well within the level of the ordinary skilled artisan to adjust the dosages and timing of administration for optimal therapeutic efficacy and safety, and to arrive at the dosages and timing of administration instantly claimed, where the administration of the complexes is expected to provide therapeutic treatment to subjects with DMD.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-6, 11, 14, 16-18, and 20-28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 12128109 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are directed to methods of administering complexes to subjects with DMD and the patent claims are directed to the same complexes and methods of administering the complexes to subjects with DMD. The instant claims differ from the patent claims in that the instant claims recite dosages of the complexes to be administered, the instant claims recite PMO is linked to the antibody at a cysteine (claim 28), and instant claims recite the subjects are “human” (see claim 22). However, the patent specification discloses subjects of the patent methods include human subjects (paragraph spanning columns 23-24, in particular). Further, the patent specification discloses linkage of the antibody to the oligonucleotide occurs at cysteine or lysine residues of the antibody (at lines 50-55 of column 24, in particular). Therefore, patent methods include methods wherein the PMO is linked to the antibody of the patent claims in the same manner as recited by instant claims. Further, the patent specification discloses administration of such complexes at a dose of 122 mg/kg a week apart (Example 2, in particular). In regards to doses and dosing schedules recited by the instant claims, it would be conventional and routine for one to perform the patent methods using various dosages and dosing schedules, including those encompassed by the claims, in order to optimized the patent method. “[W]here the general conditions of a claims are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456 (CCPA 1955) (Citing In re Dreyfus, 73 F.2d 931 (CCPA 1934); In re Waite, 168 F.2d 104 (CCPA 1948)). MPEP 2144.05 states: “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical.” In the instant case, given the known function of the recited complexes to treat DMD, it is well within the level of the ordinary skilled artisan to adjust the dosages and timing of administration for optimal therapeutic efficacy and safety, and to arrive at the dosages and timing of administration instantly claimed, where the administration of the complexes is expected to provide therapeutic treatment to subjects with DMD.
Claims 1, 4-6, 11, 14, 16-18, and 20-28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11771776 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are directed to methods of administering complexes to subjects to induce dystrophin exon 51 skipping and the patent claims are directed to the same complexes and methods of administering the complexes to subjects to induce dystrophin exon 51 skipping. The instant claims differ from the patent claims in that the instant claims recite dosages of the complexes to be administered, and the instant claims recite PMO (note: instant SEQ ID NO:21 is identical to patent SEQ ID NO:745) is linked to the antibody at a lysine or cysteine (claims 27-28). However, the patent specification discloses linkage of the PMO to the antibody occurs at cysteine or lysine residues of the antibody (at 55 and 56 of column 235). Therefore, copending methods include methods wherein the PMO is linked to the antibody of the copending claims in the same manner as recited by instant claims. Further, the copending specification discloses administration of such complexes at a dose of 1-100 mg/kg week, biweekly, monthly, etc (lines 12-21 of column 210, in particular). In regards to doses and dosing schedules recited by the instant claims, it would be conventional and routine for one to perform the copending methods using various dosages and dosing schedules, including those encompassed by the claims, in order to optimized the copending method. “[W]here the general conditions of a claims are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456 (CCPA 1955) (Citing In re Dreyfus, 73 F.2d 931 (CCPA 1934); In re Waite, 168 F.2d 104 (CCPA 1948)). MPEP 2144.05 states: “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical.” In the instant case, given the known function of the recited complexes to treat DMD and to induce dystrophin exon 51 skipping, it is well within the level of the ordinary skilled artisan to adjust the dosages and timing of administration for optimal therapeutic efficacy and safety, and to arrive at the dosages and timing of administration instantly claimed, where the administration of the complexes is expected to provide therapeutic treatment to subjects with DMD and to induce dystrophin exon 51 skipping.
Conclusion
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/SEAN E AEDER/ Primary Examiner, Art Unit 1642
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