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 .
Claim Status
Claims 1, 3-6, and 8-20 are pending for examination.
Priority
This application is a 371 of PCT/US2021/012662 01/08/2021, which claims priority to 63/055,529 (07/23/2020), 62/968,398 (01/31/2020), and 62/965,762 (01/24/2020).
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, 3-6, and 8-20 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.
Claim 1, and those claims dependent therefrom recite the limitation “wherein the antibody comprises a heavy chain complementarity determining region 1 of SEQ ID NO:49…” The use of the language “of SEQ ID NO:” with respect to SEQ ID NO: 49, 50, 51, 52, 29, and 53, suggests that the scope of the CDRs may also include fragments of SEQ ID NO: 49, 50, 51,52, 29, and 53. Thus, the scope of the claimed CDRs in the claimed anti-transferrin receptor antibody complex is uncertain, because it is unclear if the CDR sequences are limited to the full length sequences of SEQ ID NO: 49, 50, 51,52, 29, and 53, or should be interpreted to include smaller fragments “of” these sequences.
Claim 4 remains rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, for the reasons of record, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim 4, which depends from claim 1, recites wherein the antibody comprises a VH comprising an amino acid sequence at least 40% identical to SEQ ID NOs: 54, and a VL comprising at least 80% identity to 55, Thus, the scope of the VH and VL sequences of claim 4 is broader that the scope of the Vi and VL sequences recited in claim 1, which can also be interpreted as requiring that VH and VL have 100% identity to SEQ ID NOs: 54 and 55, respectively.
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.
In the response filed 08/11/2025, Applicants did not address the merits of the Double Patenting Rejections set forth below, but stated that “theses provisional rejections be held in abeyance until allowable subject matter is agreed upon.” Since the claims are not considered allowable, the claims remain rejected for the reasons of record.
Claims 1, 3-6, and 8-20 stand provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-6, and 18-20 of copending Application No. 17791667 (US20230226212A1, priority to 62/659,804 01/10/2020). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘667 claims anticipate the instant claims.
In the response filed 08/11/2025, Applicants did not address the merits of the Double Patenting Rejections set forth below, but stated that “theses provisional rejections be held in abeyance until allowable subject matter is agreed upon.” Since the claims are not considered allowable, the claims remain rejected for the reasons of record.
The instant claims in their broadest are drawn to a complex comprising an anti-transferrin receptor antibody covalently linked to a molecular payload configured to inhibit expression or activity of a pro-atrophy, wherein the antibody comprises a heavy chain complementarity determining region 1 (CDR-H1), a heavy chain complementarity determining region 2 (CDR-H2), a heavy chain complementarity determining region 3 (CDR-H3) of a heavy chain variable region (VH) comprising the amino acid sequence of SEQ ID NO: 54, and a light chain complementarity determining region 1 (CDR-L1), a light chain complementarity determining region 2 (CDR-L2), a light chain complementarity determining region 3 (CDR-L3) of a light chain variable region (VL) comprising the amino acid sequence of SEQ ID NO: 55. Dependent claims 7-16 recite wherein the payload is an oligonucleotide. Dependent claims recite methods of delivering the payload to a cell, methods of inhibiting expression of a muscle disease gene in a cell by contacting with the complex and methods of treating a subject by administering the complex (claims 18-20).
The claims of the ’667 application are drawn to complex comprising an anti-transferrin receptor antibody covalently linked to a molecular payload configured for modulating expression or activity of a muscle disease gene, wherein the antibody comprises a heavy chain complementarity determining region 1 (CDR-H1), a heavy chain complementarity determining region 2 (CDR-H2), a heavy chain complementarity determining region 3 (CDR-H3) of a heavy chain variable region (VH) comprising the amino acid sequence of SEQ ID NO: 54, and a light chain complementarity determining region 1 (CDR-L1), a light chain complementarity determining region 2 (CDR-L2), a light chain complementarity determining region 3 (CDR-L3) of a light chain variable region (VL) comprising the amino acid sequence of SEQ ID NO: 55. Dependent claims 7-12 recite wherein the payload is an oligonucleotide. Dependent claims recite methods of delivering the payload to a cell, methods of inhibiting expression of a muscle disease gene in a cell by contacting with the complex and methods of treating a subject by administering the complex (claims 18-20).
Thus, the difference between the two sets of claims is the specific pro-atrophy muscle disease associated gene that is targeted by the molecular payload, whereas copending claims are generic to this aspect and targeting is to modulating expression or activity to any muscle disease gene. However, the claims of the ‘667 application would necessarily anticipate the instant claims because the generic modulation of expression/activity of any muscle disease gene targeted by the molecular payload would anticipate the inhibition of pro-atrophy gene expression and/or activity.
Claims 1, 3-6, and 8-20 stand provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-19 and 24-25 of copending Application No. 17791670 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘670 claims anticipate the instant claims.
The instant claims in their broadest are drawn to a complex comprising an anti-transferrin receptor antibody covalently linked to a molecular payload configured for to inhibit expression or activity of a pro-atrophy gene, wherein the antibody comprises a heavy chain complementarity determining region 1 (CDR-H1), a heavy chain complementarity determining region 2 (CDR-H2), a heavy chain complementarity determining region 3 (CDR-H3) of a heavy chain variable region (VH) comprising the amino acid sequence of SEQ ID NO: 54, and a light chain complementarity determining region 1 (CDR-L1), a light chain complementarity determining region 2 (CDR-L2), a light chain complementarity determining region 3 (CDR-L3) of a light chain variable region (VL) comprising the amino acid sequence of SEQ ID NO: 55. Dependent claims 7-16 recite wherein the payload is an oligonucleotide. Dependent claims recite methods of delivering the payload to a cell, methods of inhibiting expression of a muscle disease gene in a cell by contacting with the complex and methods of treating a subject by administering the complex.
The claims to the ‘670 application are drawn to a complex comprising a muscle-targeting agent covalently linked to a molecular payload that modulates the expression or activity of myostatin (MSTN), inhibin beta A (INHBA) and/or activin receptor type-1B (ACVR1B), wherein the muscle-targeting agent specifically binds to an internalizing cell surface receptor on a muscle cell; with dependent claim 3 reciting wherein the antibody comprises a heavy chain complementarity determining region 1 (CDR-H1), a heavy chain complementarity determining region 2 (CDR-H2), a heavy chain complementarity determining region 3 (CDR-H3) of a heavy chain variable region (VH) comprising the amino acid sequence of SEQ ID NO: 54, and a light chain complementarity determining region 1 (CDR-L1), a light chain complementarity determining region 2 (CDR-L2), a light chain complementarity determining region 3 (CDR-L3) of a light chain variable region (VL) comprising the amino acid sequence of SEQ ID NO: 55. Dependent claims 12-19 recite wherein the payload is an oligonucleotide.
Although the instant claims are broadly drawn to wherein the molecular payload is configured to inhibit a pro-atrophy gene, the specification as filed teaches wherein the molecular payload targets muscle atrophy genes, including MSTN and INHBA. See ¶ [00078], which discloses: “[I]n some embodiments, more than one gene in Table 1 is targeted. In some embodiments, the complex comprises molecular payloads targeting MSTN (encoding myostatin), INHBA (encoding activin A), FBXO32, TRIM63, or any combination thereof, for example MSTN and INHBA.”
Thus, when claims 1 and 3 are combined, the difference is the specific muscle atrophy genes that are targeted, whereas the instant claims are generic to this aspect. However, the claims of the ‘670 would necessarily anticipate the instant claims.
As per MPEP 804(II)(B)(1): “The claim under examination is not patentably distinct from the reference claim(s) if the claim under examination is anticipated by 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, 1052, 29 USPQ2d 2010, 2015-16 (Fed. Cir. 1993).
This type of nonstatutory double patenting situation arises when the claim being examined is, for example, generic to a species or sub-genus claimed in a conflicting patent or application, i.e., the entire scope of the reference claim falls within the scope of the examined claim.”
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 3-6, and 8-20 stand provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 17791681 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘681 claims anticipate the instant claims.
The instant claims in their broadest are drawn to a complex comprising an anti-transferrin receptor antibody covalently linked to a molecular payload configured for to inhibit expression or activity of a pro-atrophy gene, wherein the antibody comprises a heavy chain complementarity determining region 1 (CDR-H1), a heavy chain complementarity determining region 2 (CDR-H2), a heavy chain complementarity determining region 3 (CDR-H3) of a heavy chain variable region (VH) comprising the amino acid sequence of SEQ ID NO: 54, and a light chain complementarity determining region 1 (CDR-L1), a light chain complementarity determining region 2 (CDR-L2), a light chain complementarity determining region 3 (CDR-L3) of a light chain variable region (VL) comprising the amino acid sequence of SEQ ID NO: 55. Dependent claims 7-16 recite wherein the payload is an oligonucleotide. Dependent claims recite methods of delivering the payload to a cell, methods of inhibiting expression of a muscle disease gene in a cell by contacting with the complex and methods of treating a subject by administering the complex (claims 18-20).
The claims to the ‘681 application are drawn to A complex comprising an anti-transferrin receptor antibody covalently linked to a molecular payload configured for inhibiting DMPK expression or activity, wherein the antibody comprises a heavy chain complementarity determining region 1 (CDR-H1), a heavy chain complementarity determining region 2 (CDR-H2), a heavy chain complementarity determining region 3 (CDR-H3) of a heavy chain variable region (VH) comprising the amino acid sequence of SEQ ID NO: 54, and a light chain complementarity determining region 1 (CDR-L1), a light chain complementarity determining region 2 (CDR-L2), a light chain complementarity determining region 3 (CDR-L3) of a light chain variable region (VL) comprising the amino acid sequence of SEQ ID NO: 55. Dependent claims 7-12 recite wherein the payload is an oligonucleotide. Dependent claims recite methods of delivering the payload to a cell, methods of inhibiting expression of a muscle disease gene DMPK in a cell by contacting with the complex and methods of treating a subject with a muscle disease associated-repeat of DMPK by administering the complex (claims 19-20).
Thus, the difference between the two sets of claims is the specific muscle disease associated gene of DMPK that is targeted by the molecular payload, whereas the instant claims are generic to this aspect and targeting is to any muscle disease gene. However, the claims of the ‘681 would necessarily anticipate the instant claims because the specific inhibition of the species of DMPK gene would anticipate the generic modulation of expression/activity of any pro-atrophy gene targeted by the molecular payload. Additionally, the specification as filed describes DMPK as one of the targets of the molecular payload of the claimed complex. See examples.
As per MPEP 804(II)(B)(1): “The claim under examination is not patentably distinct from the reference claim(s) if the claim under examination is anticipated by 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, 1052, 29 USPQ2d 2010, 2015-16 (Fed. Cir. 1993). This type of nonstatutory double patenting situation arises when the claim being examined is, for example, generic to a species or sub-genus claimed in a conflicting patent or application, i.e., the entire scope of the reference claim falls within the scope of the examined claim.”
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 3-6, and 8-20 stand provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 17791697 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘697 claims anticipate the instant claims.
The instant claims in their broadest are drawn to a complex comprising an anti-transferrin receptor antibody covalently linked to a molecular payload configured for to inhibit expression or activity of a pro-atrophy gene, wherein the antibody comprises a heavy chain complementarity determining region 1 (CDR-H1), a heavy chain complementarity determining region 2 (CDR-H2), a heavy chain complementarity determining region 3 (CDR-H3) of a heavy chain variable region (VH) comprising the amino acid sequence of SEQ ID NO: 54, and a light chain complementarity determining region 1 (CDR-L1), a light chain complementarity determining region 2 (CDR-L2), a light chain complementarity determining region 3 (CDR-L3) of a light chain variable region (VL) comprising the amino acid sequence of SEQ ID NO: 55. Dependent claims 7-12 recite wherein the payload is an oligonucleotide. Dependent claims recite methods of delivering the payload to a cell, methods of inhibiting expression of a muscle disease gene in a cell by contacting with the complex and methods of treating a subject by administering the complex (claims 18-20).
The claims to the ‘697 application are drawn to A complex comprising an anti-transferrin receptor antibody covalently linked to a molecular payload configured for inhibiting expression or activity of Double Homeobox 4 (DUX4), wherein the antibody comprises a heavy chain complementarity determining region 1 (CDR-H1), a heavy chain complementarity determining region 2 (CDR-H2), a heavy chain complementarity determining region 3 (CDR-H3) of a heavy chain variable region (VH) comprising the amino acid sequence of SEQ ID NO: 54, and a light chain complementarity determining region 1 (CDR-L1), a light chain complementarity determining region 2 (CDR-L2), a light chain complementarity determining region 3 (CDR-L3) of a light chain variable region (VL) comprising the amino acid sequence of SEQ ID NO: 55. Dependent claims 7-16 recite wherein the payload is an oligonucleotide. Dependent claims recite methods of delivering the payload to a cell, methods of inhibiting expression of a muscle disease gene DUX4K in a cell by contacting with the complex and methods of treating a subject with a muscle disease associated-repeat of DUX4 by administering the complex (claims 19-20).
Thus, the difference between the two sets of claims is the specific muscle disease associated gene of DUX4 that is targeted by the molecular payload, whereas the instant claims are generic to this aspect and targeting is to any pro-atrophy gene. However, the claims of the ‘697 would necessarily anticipate the instant claims because the specific inhibition of the species of DUX4 gene would anticipate the generic modulation of expression/activity of any pro-atrophy gene targeted by a molecular payload.
As per MPEP 804(II)(B)(1): “The claim under examination is not patentably distinct from the reference claim(s) if the claim under examination is anticipated by 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, 1052, 29 USPQ2d 2010, 2015-16 (Fed. Cir. 1993). This type of nonstatutory double patenting situation arises when the claim being examined is, for example, generic to a species or sub-genus claimed in a conflicting patent or application, i.e., the entire scope of the reference claim falls within the scope of the examined claim.”
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 3-6, and 8-20 stand provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 17791701 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘701 claims anticipate the instant claims.
The instant claims in their broadest are drawn to a complex comprising an anti-transferrin receptor antibody covalently linked to a molecular payload configured for to inhibit expression or activity of a pro-atrophy gene, wherein the antibody comprises a heavy chain complementarity determining region 1 (CDR-H1), a heavy chain complementarity determining region 2 (CDR-H2), a heavy chain complementarity determining region 3 (CDR-H3) of a heavy chain variable region (VH) comprising the amino acid sequence of SEQ ID NO: 54, and a light chain complementarity determining region 1 (CDR-L1), a light chain complementarity determining region 2 (CDR-L2), a light chain complementarity determining region 3 (CDR-L3) of a light chain variable region (VL) comprising the amino acid sequence of SEQ ID NO: 55. Dependent claims 7-12 recite wherein the payload is an oligonucleotide. Dependent claims recite methods of delivering the payload to a cell, methods of inhibiting expression of a pro-atrophy gene in a cell by contacting with the complex and methods of treating a subject having muscle atrophy by administering the complex (claims 18-20).
The claims to the ‘701 application are drawn to A complex comprising an anti-transferrin receptor antibody covalently linked to a molecular payload configured for inducing skipping of an exon in a dystrophin (DMD) mRNA, wherein the antibody comprises a heavy chain complementarity determining region 1 (CDR-H1), a heavy chain complementarity determining region 2 (CDR-H2), a heavy chain complementarity determining region 3 (CDR-H3) of a heavy chain variable region (VH) comprising the amino acid sequence of SEQ ID NO: 54, and a light chain complementarity determining region 1 (CDR-L1), a light chain complementarity determining region 2 (CDR-L2), a light chain complementarity determining region 3 (CDR-L3) of a light chain variable region (VL) comprising the amino acid sequence of SEQ ID NO: 55. Dependent claims 7-11 recite wherein the payload is an oligonucleotide. Dependent claims recite methods of delivering the payload to a cell, methods of inducing skipping of an exon in DMD muscle cell by contacting with the complex and methods of treating a subject with a muscle disease caused by mutated DMD by administering the complex (claims 16-20).
Thus, the difference between the two sets of claims is the specific dystrophin (DMD) muscle disease associated gene’s mRNA that is targeted by the molecular payload, whereas the instant claims are generic to this aspect and targeting is inhibiting the expression or activity to any pro-atrophy gene. However, the claims of the ‘701 application would necessarily anticipate the instant claims because the specific modulation of the mutated DMD mRNA would anticipate the generic inhibition of expression/activity of any pro-atrophy gene targeted by the molecular payload.
As per MPEP 804(II)(B)(1): “The claim under examination is not patentably distinct from the reference claim(s) if the claim under examination is anticipated by 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, 1052, 29 USPQ2d 2010, 2015-16 (Fed. Cir. 1993). This type of nonstatutory double patenting situation arises when the claim being examined is, for example, generic to a species or sub-genus claimed in a conflicting patent or application, i.e., the entire scope of the reference claim falls within the scope of the examined claim.”
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 3-6 and 8-20 are provisionally rejected on the ground of nonstatutory double
patenting as being unpatentable over claims 1-7, 9, 11-12 and 14 of copending Application No. 17/796,418 hereinafter, ‘418. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘418 claims anticipate the instant claims.
The claims of ‘418 are drawn to an antibody that binds to human transferrin receptor (TfR),
wherein the antibody comprises the antibody comprises a heavy chain complementarity determining region 1 (CDR-H1), a heavy chain complementarity determining region 2 (CDR-H2), a heavy chain complementarity determining region 3 (CDR-H3) of a heavy chain variable region (VH) comprising the amino acid sequence of SEQ ID NO: 54, and a light chain complementarity determining region 1 (CDR-L1), a light chain complementarity determining region 2 (CDR-L2), a light chain complementarity determining region 3 (CDR-L3) of a light chain variable region (VL) comprising the amino acid sequence of SEQ ID NO: 55. Dependent claim 14 recites wherein the antibody is in a complex with a molecular payload.
The instant claims are drawn to a complex comprising an anti-transferrin receptor antibody
covalently linked to an oligonucleotide that targets a pro-atrophy gene, wherein the antibody comprises a heavy chain complementarity determining region 1 (CDR-H1), a heavy chain complementarity determining region 2 (CDR-H2), a heavy chain complementarity determining region 3 (CDR-H3) of heavy chain variable region (VH) comprising the amino acid sequence of SEQ ID NO: 54, and a light chain complementarity determining region 1 (CDR-L1), a light chain complementarity determining region 2 (CDR-L2), a light chain complementarity determining region 3 (CDR-L3) of a light chain variable region (VL) comprising the amino acid sequence of SEQ ID NO: 55.
Thus, the difference between the two sets of claims is the claims of the instant application are drawn to a specific pro-atrophy muscle disease associated gene that is targeted by the oligonucleotide recited in claim 1, whereas the copending claims are generic to this aspect and target the modulation of expression or activity to any muscle disease gene. As such, the claims of the ‘418 application would necessarily anticipate the instant claims because the inhibition of pro-atrophy gene expression and/or activity reads on the generic modulation of expression/activity of any muscle disease gene targeted by the molecular payload.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowable.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 JANET L EPPS-SMITH whose telephone number is (571)272-0757. The examiner can normally be reached M-F, 10:00 AM-6:30 PM.
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, please contact Patricia Mallari (Director TC1600) at (571) 272-4729. 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.
/JANET L EPPS -SMITH/Supervisory Patent Examiner, Art Unit 1646