DETAILED ACTION
Status of Application
The amendments and response filed 07 August 2025 are acknowledged and have been considered in their entireties. Claims 2 and 7 are cancelled thus, claims 1, 3-6 and 8-20 remain pending and subject to examination on the merits.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07 August 2025 has been considered by the examiner. See initialed and signed PTO/SB/08.
Withdrawal of Previous Rejections
The rejection of claims 1-20 under 35 U.S.C. 112(a), written description, is withdrawn in view of the amendments to claim 1 to recite the payload as an oligonucleotide.
New Rejection(s) – Necessitated by Amendments
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 for being indefinite for the recitation directed to the CDR sequences being “of SEQ ID NO: 49/50/51/52/29/53). It is unclear whether the breadth of the claims is intended to encompass the full length sequences or fragments of said sequences. Accordingly, the metes and bounds of the sequences cannot be ascertained from the claims.
Claims 3-6, 8-20 are included in the instant rejection as they do not remedy the noted deficiency.
The rejection can be overcome by removing “of” prior to the occurrences of the sequence identifiers.
Maintained (and/or Modified) Rejections
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 4 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, 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 1 recites CDR-H1/2/3’s of a heavy chain variable region (VH) comprising SEQ ID NOs: 49, 50, 51, respectively; in addition, CDR-L1/2/3’s of a light chain variable region (VL) comprising SEQ ID NOs: 52, 29, 53, respectively.
As noted above, there is ambiguity as to whether or not the CDR’s are to be the full length sequences recited in claim 1 or fragments. In interpreting that the sequences do require the full length sequences (again, one possible interpretation), then claim 4 reciting the VH and VL need only have 80% sequence identity to SEQ ID NOs: 54 and 55, respectively, would still make claim 4 broader because there is nothing in the claim which restricts that the variability from occurring in the CDR sequences of SEQ ID NOs: 49, 50, 51, respectively; in addition, CDR-L1/2/3’s of a light chain variable region (VL) comprising SEQ ID NOs: 52, 29, 53.
Amending the claim to preclude any variability in the CDR regions would overcome this rejection.
Applicant’s Response and Examiner’s Rebuttal:
Applicant’s state that by specifically reciting the CDR’s in claim 1, and the limitations of said claim are incorporated into claim 4, then the recitation of 80% identity to SEQ ID NO: 54 (VH) and SEQ ID NO: 55 (VL) would not be broader in scope.
The Examiner has considered this argument but does not find it convincing because as noted in the modified rejection above, claim 4 stipulates that the 20% variability in the sequence can occur anywhere in the sequences, including in the recited CDR’s.
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, 3-6 and 8-20 are 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 render obvious the instant claims.
The instant claims in their broadest are drawn to a complex comprising an anti-transferrin receptor antibody covalently linked to an oligonucleotide that targets a muscle disease gene, wherein the antibody comprises a heavy chain complementarity determining region 1 (CDR-H1) of SEQ ID NO: 49, a heavy chain complementarity determining region 2 (CDR-H2) of SEQ ID NO: 50, a heavy chain complementarity determining region 3 (CDR-H3) of SEQ ID NO:51, and a light chain complementarity determining region 1 (CDR-L1) of SEQ ID NO: 52, a light chain complementarity determining region 2 (CDR-L2) of SEQ ID NO: 29, a light chain complementarity determining region 3 (CDR-L3) of SEQ ID NO: 53. Dependent claim 4 recites wherein the antibody comprises a VH comprising an amino acid sequence having at least 80% identity to SEQ ID NO: 54 and a VL comprising an amino acid sequence comprising at least 80% identity to SEQ ID NO: 55. Dependent claims 8-16 recite characteristics of the oligonucleotide. Dependent claims 18-20 recite methods of delivering an oligonucleotide 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 by utilizing the complex of claim 1.
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 4 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. Dependent claims 10, 12, 14 recites wherein the molecular payload is an oligonucleotide comprising an antisense strand that targets MSTN, INHBA and ACVR1B (e.g. muscle disease genes); and claims 24-25 recites treating muscle atrophy by administering the antibody and molecular payload to target MSTN, INHBA and/or ACVR1B by reducing expression of said genes.
Thus, when claims 1 and 10/12/14/25; and claims 1 and 4 are combined from the ‘670 application, it would render the instant claims as obvious because the same antibody comprising specific muscle disease targeting oligonucleotides for MSTN, INHBA and/or ACVR1B would render obvious the instant claims because the difference is the specific muscle cells and genes that are targeted, whereas the instant claims are generic to this aspect and target any muscle disease gene.
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 1-6, 8-20 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 an oligonucleotide that targets a muscle disease gene, wherein the antibody comprises a heavy chain complementarity determining region 1 (CDR-H1) of SEQ ID NO: 49, a heavy chain complementarity determining region 2 (CDR-H2) of SEQ ID NO: 50, a heavy chain complementarity determining region 3 (CDR-H3) of SEQ ID NO:51, and a light chain complementarity determining region 1 (CDR-L1) of SEQ ID NO: 52, a light chain complementarity determining region 2 (CDR-L2) of SEQ ID NO: 29, a light chain complementarity determining region 3 (CDR-L3) of SEQ ID NO: 53. Dependent claim 4 recites wherein the antibody comprises a VH comprising an amino acid sequence having at least 80% identity to SEQ ID NO: 54 and a VL comprising an amino acid sequence comprising at least 80% identity to SEQ ID NO: 55. Dependent claims 8-16 recite characteristics of the oligonucleotide. Dependent claims 18-20 recite methods of delivering an oligonucleotide 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 by utilizing the complex of claim 1.
The claims to the ‘681 application are drawn to A complex comprising an anti-transferrin receptor antibody covalently linked to an oligonucleotide that targets 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 muscle disease gene targeted by the molecular payload.
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 1-20 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 an oligonucleotide that targets a muscle disease gene, wherein the antibody comprises a heavy chain complementarity determining region 1 (CDR-H1) of SEQ ID NO: 49, a heavy chain complementarity determining region 2 (CDR-H2) of SEQ ID NO: 50, a heavy chain complementarity determining region 3 (CDR-H3) of SEQ ID NO:51, and a light chain complementarity determining region 1 (CDR-L1) of SEQ ID NO: 52, a light chain complementarity determining region 2 (CDR-L2) of SEQ ID NO: 29, a light chain complementarity determining region 3 (CDR-L3) of SEQ ID NO: 53. Dependent claim 4 recites wherein the antibody comprises a VH comprising an amino acid sequence having at least 80% identity to SEQ ID NO: 54 and a VL comprising an amino acid sequence comprising at least 80% identity to SEQ ID NO: 55. Dependent claims 8-16 recite characteristics of the oligonucleotide. Dependent claims 18-20 recite methods of delivering an oligonucleotide 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 by utilizing the complex of claim 1.
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 muscle disease 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 muscle disease gene targeted by the molecular payload.
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, 3-6 and 8-20 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 an oligonucleotide that targets a muscle disease gene, wherein the antibody comprises a heavy chain complementarity determining region 1 (CDR-H1) of SEQ ID NO: 49, a heavy chain complementarity determining region 2 (CDR-H2) of SEQ ID NO: 50, a heavy chain complementarity determining region 3 (CDR-H3) of SEQ ID NO:51, and a light chain complementarity determining region 1 (CDR-L1) of SEQ ID NO: 52, a light chain complementarity determining region 2 (CDR-L2) of SEQ ID NO: 29, a light chain complementarity determining region 3 (CDR-L3) of SEQ ID NO: 53. Dependent claim 4 recites wherein the antibody comprises a VH comprising an amino acid sequence having at least 80% identity to SEQ ID NO: 54 and a VL comprising an amino acid sequence comprising at least 80% identity to SEQ ID NO: 55. Dependent claims 8-16 recite characteristics of the oligonucleotide. Dependent claims 18-20 recite methods of delivering an oligonucleotide 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 by utilizing the complex of claim 1.
The claims to the ‘701 application are drawn to A complex comprising an anti-transferrin receptor antibody covalently linked to an oligonucleotide that induces dystrophin (DMD) exon skipping, wherein the antibody comprises a heavy chain complementarity determining region 1 (CDR-H1) of SEQ ID NO: 49, a heavy chain complementarity determining region 2 (CDR-H2) of SEQ ID NO: 50, a heavy chain complementarity determining region 3 (CDR-H3) of SEQ ID NO:51, and a light chain complementarity determining region 1 (CDR-L1) of SEQ ID NO: 52, a light chain complementarity determining region 2 (CDR-L2) of SEQ ID NO: 29, a light chain complementarity determining region 3 (CDR-L3) of SEQ ID NO: 53. Dependent claim 4 recites wherein the antibody comprises a VH comprising an amino acid sequence having at least 80% identity to SEQ ID NO: 54 and a VL comprising an amino acid sequence comprising at least 80% identity to SEQ ID NO: 55. Dependent claims 8-11 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 to modulating expression or activity to any muscle disease 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 modulation of expression/activity of any muscle disease gene targeted by the molecular payload.
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, 3-6 and 8-20 of copending Application No. 17794768 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘768 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 an oligonucleotide that targets a muscle disease gene, wherein the antibody comprises a heavy chain complementarity determining region 1 (CDR-H1) of SEQ ID NO: 49, a heavy chain complementarity determining region 2 (CDR-H2) of SEQ ID NO: 50, a heavy chain complementarity determining region 3 (CDR-H3) of SEQ ID NO:51, and a light chain complementarity determining region 1 (CDR-L1) of SEQ ID NO: 52, a light chain complementarity determining region 2 (CDR-L2) of SEQ ID NO: 29, a light chain complementarity determining region 3 (CDR-L3) of SEQ ID NO: 53. Dependent claim 4 recites wherein the antibody comprises a VH comprising an amino acid sequence having at least 80% identity to SEQ ID NO: 54 and a VL comprising an amino acid sequence comprising at least 80% identity to SEQ ID NO: 55. Dependent claims 8-16 recite characteristics of the oligonucleotide. Dependent claims 18-20 recite methods of delivering an oligonucleotide 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 by utilizing the complex of claim 1.
The claims to the ‘768 application 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) of SEQ ID NO: 49, a heavy chain complementarity determining region 2 (CDR-H2) of SEQ ID NO: 50, a heavy chain complementarity determining region 3 (CDR-H3) of SEQ ID NO:51, and a light chain complementarity determining region 1 (CDR-L1) of SEQ ID NO: 52, a light chain complementarity determining region 2 (CDR-L2) of SEQ ID NO: 29, a light chain complementarity determining region 3 (CDR-L3) of SEQ ID NO: 53. Dependent claim 4 recites wherein the antibody comprises a VH comprising an amino acid sequence having at least 80% identity to SEQ ID NO: 54 and a VL comprising an amino acid sequence comprising at least 80% identity to SEQ ID NO: 55. Dependent claims 8-16 recite wherein the payload is an oligonucleotide. Dependent claims recite methods of delivering the payload to a cell, methods of inhibiting expression of a pro-atrophy gene in a cell by contacting with the complex and methods of treating a subject with a muscle atrophy (e.g. a muscle disease) 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 the instant claims are generic to this aspect and targeting is to modulating expression or activity to any muscle disease gene. However, the claims of the ‘768 application would necessarily anticipate the instant claims because the specific inhibition of a pro-atrophy gene expression/acitivty would anticipate the generic modulation of expression/activity of any muscle disease gene targeted by the molecular payload.
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, 11-20 of copending Application No. 17796418 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘418 claims anticipate and/or renders obvious the instant claims.
The instant claims in their broadest are drawn to a complex comprising an anti-transferrin receptor antibody covalently linked to an oligonucleotide that targets a muscle disease gene, wherein the antibody comprises a heavy chain complementarity determining region 1 (CDR-H1) of SEQ ID NO: 49, a heavy chain complementarity determining region 2 (CDR-H2) of SEQ ID NO: 50, a heavy chain complementarity determining region 3 (CDR-H3) of SEQ ID NO:51, and a light chain complementarity determining region 1 (CDR-L1) of SEQ ID NO: 52, a light chain complementarity determining region 2 (CDR-L2) of SEQ ID NO: 29, a light chain complementarity determining region 3 (CDR-L3) of SEQ ID NO: 53. Dependent claim 4 recites wherein the antibody comprises a VH comprising an amino acid sequence having at least 80% identity to SEQ ID NO: 54 and a VL comprising an amino acid sequence comprising at least 80% identity to SEQ ID NO: 55. Dependent claims 8-16 recite characteristics of the oligonucleotide. Dependent claims 18-20 recite methods of delivering an oligonucleotide 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 by utilizing the complex of claim 1.
The claims to the ‘418 application 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. Dependent claims recite methods of delivering the payload to a muscle cell and methods of treating a subject with a muscle disease or brain disease by administering the complex (claims 18-20). While the claims of ‘418 application do not recite what the molecular payload is, it is clear when construing the scope of the claims in understanding what a molecular payload is as defined in the specification (See MPEP 804(II)(B)(1)), that molecular payloads are inclusive of oligonucleotides (for example at paragraph 0028, 0038, 0372-0374 PG-Pub)).
Thus, the difference between the two sets of claims is the claims to the ‘419 application do not recite the payload is targeted to a muscle disease gene for expression or activity modulation associated with a muscle disease. However, given that the claims recite targeting muscle cells for treating a muscle disease, it would be obvious that one of the targets would be the muscle disease aberrant genes.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
N.B. instant SEQ ID NOs: 54 and 55 have 100% sequence identity to the SEQ ID NOs: 54 and 55 recited in each of the NSDP rejections/claims as described above – See Supplemental Content, 20250501_103621_us-17-791-667-54.rapbm file, Result #1; and 20250501_103621_us-17-791-667-55.rapbm, Result #1.
Applicant’s Response
Applicant’s have requested the rejections be held in abeyance until such time that allowable subject matter is agreed upon.
The Examiner acknowledges this request, however, the rejections are maintained for the reasons recited above and of record.
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 SUZANNE M NOAKES whose telephone number is (571)272-2924. The examiner can normally be reached M-F (7-4).
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/SUZANNE M NOAKES/Primary Examiner, Art Unit 1656 16 October 2025