DETAILED ACTION
Status of Application, Amendments and/or Claims
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 23-39 are pending.
The election without traverse of “Duchenne’s muscular dystrophy” as the species of disease in the reply filed on 8/5/25 is acknowledged. Applicants indicate claims 23-31 encompass the species. Claims 32-39 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
Claims 23-31 are under consideration, as they read upon the elected species.
Specification
The disclosure is objected to because of the following informalities:
The title of the invention is not descriptive because t it is directed generally to any method of inhibiting myostatin activation, whereas but the claims are limited to methods of treatment of muscular dystrophy or osteogenesis imperfecta. A new title is required that is clearly indicative of the invention to which the claims are directed. The following title is suggested: “Methods of Treating Muscular Dystrophy or Osteogenesis Imperfecta by Administering Anti-Pro/Latent-Myostatin Antibodies”.
Appropriate correction is required.
Note on Prior Art Rejection(s)
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
(1) Claims 23-31 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Straub et al, U.S. Patent Application Publication 2017/0333558, published 11/23/17 and claiming priority to 11/6/14 (cited on the 4/25/24 IDS). The earliest date to which the instant application claims priority is 1/8/16.
Instant independent claim 23 encompasses a method of treating a subject having a muscular dystrophy by administering an effective amount of an antibody that comprises a heavy chain sequence of SEQ ID NO: 25 and a light chain sequence of SEQ ID NO: 31. Straub teaches antibodies that bind to pro and/or latent myostatin (¶ 4), including Ab2 that comprises SEQ ID NO: 25 and 31, which are identical to instant SEQ ID NO: 25 and 31 (Table 3). Straub further teaches that the antibodies can be used for treatment of muscular dystrophy (¶ 19). As such, the teachings of Straub anticipate claim 23.
In each of claims 24 and 25, the concluding wherein clause has been fully considered in context of the entire claim, but does not render the claimed method patentably distinct from a method claimed by another application or patent because it simply expresses the intended result of a process step positively recited. See MPEP 2111.04, which states that a "whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited" (Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), quoting Minton v. Nat ’l Ass ’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). Specifically, in each of these claims, the further limitation simply express the intended result of a process step positively recited; i.e., administration of an effective amount of the antibody for treatment. As such, each additional limitation is not sufficient to render the dependent claim patentably distinct from the claims of Straub. As such, the teachings of Straub also anticipate claims 24 and 25.
Claim 26 limits the antibody of the method of claim 23 to one that inhibits activation of mature myostatin by tolloid protease with an IC50 of less than 1 µM. Straub further teaches such an functional activity for antibodies of the invention in ¶ 17. As such, the teachings of Straub also anticipate claim 26.
Claim 27 limits the method of claim 23 to one wherein the antibody comprising an IgG4 constant domain. Straub further teaches that Ab2 has an IgG4 constant domain (¶ 206). As such, the teachings of Straub also anticipate claim 27.
Claim 28 encompasses a method of claim 23 wherein the antibody is administered intravenously. Straub further teaches that the antibody can be administered intravenously (¶ 30). As such, the teachings of Straub also anticipate claim 28.
Claim 29 limits the method of claim 23 to one wherein the subject is treated with one or more additional therapies. Straub further teaches that the antibodies of the invention can be combined with “one or more other active agents” (¶ 161). As such, the teachings of Straub also anticipate claim 29.
Claim 30 encompasses a method of claim 23 wherein the dystrophy is Duchenne’s. Straub further teaches that an exemplary muscular dystrophy to be treated is Duchenne’s (¶ 26). As such, the teachings of Straub also anticipate claim 30.
Claim 31 encompasses a method of claim 23 wherein the antibody comprising the heavy and light chain sequences of SEQ ID NO: 50 and 51. Straub further discloses these sequences as exemplary embodiments of an antibody of the invention (Figure 21; the Brief Description of Figure 21 in col 9-10; Table 1 in col 21). As such, the teachings of Straub also anticipate claim 31.
(2) Claims 23-31 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Carven et al, U.S. Patent Application Publication 20180344844, published 12/6/18 and claiming priority to 9/15/15. The earliest date to which the instant application claims priority is 1/8/16.
Instant independent claim 23 encompasses a method of treating a subject having a muscular dystrophy by administering an effective amount of an antibody that comprises a heavy chain sequence of SEQ ID NO: 25 and a light chain sequence of SEQ ID NO: 31. Carven teaches antibodies that bind to pro and/or latent myostatin (¶ 4), including Ab2 that comprises SEQ ID NO: 25 and 31, which are identical to instant SEQ ID NO: 25 and 31 (Table 1). Carven further teaches that the antibodies can be used for treatment of muscular dystrophy (¶ 18). As such, the teachings of Carven anticipate claim 23.
In each of claims 24 and 25, the concluding wherein clause has been fully considered in context of the entire claim, but does not render the claimed method patentably distinct from a method claimed by another application or patent because it simply expresses the intended result of a process step positively recited. See MPEP 2111.04, which states that a "whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited" (Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), quoting Minton v. Nat ’l Ass ’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). Specifically, in each of these claims, the further limitation simply express the intended result of a process step positively recited; i.e., administration of an effective amount of the antibody for treatment. As such, each additional limitation is not sufficient to render the dependent claim patentably distinct from the claims of Carven. As such, the teachings of Carven also anticipate claims 24 and 25.
Claim 26 limits the antibody of the method of claim 23 to one that inhibits activation of mature myostatin by tolloid protease with an IC50 of less than 1 µM. Carven further teaches such an functional activity for antibodies of the invention in ¶ 16. As such, the teachings of Carven also anticipate claim 26.
Claim 27 limits the method of claim 23 to one wherein the antibody comprising an IgG4 constant domain. Carven further teaches that Ab2 has an IgG4 constant domain (¶ 86). As such, the teachings of Carven also anticipate claim 27.
Claim 28 encompasses a method of claim 23 wherein the antibody is administered intravenously. Carven further teaches that the antibody can be administered intravenously (¶ 30). As such, the teachings of Carven also anticipate claim 28.
Claim 29 limits the method of claim 23 to one wherein the subject is treated with one or more additional therapies. Carven further teaches that “treating” can be with “one or more other active agents” (¶ 223). As such, the teachings of Carven also anticipate claim 29.
Claim 30 encompasses a method of claim 23 wherein the dystrophy is Duchenne’s. Carven further teaches that an exemplary muscular dystrophy to be treated is Duchenne’s (¶ 26). As such, the teachings of Carven also anticipate claim 30.
Claim 31 encompasses a method of claim 23 wherein the antibody comprising the heavy and light chain sequences of SEQ ID NO: 50 and 51. Carven further discloses these sequences as exemplary embodiments of an antibody of the invention (Figure 21; the Brief Description of Figure 21 in col 9-10; Table 1 in col 21). As such, the teachings of Carven also anticipate claim 31.
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); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer (TD) 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 §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A TD must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains TD forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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 (eTD) may be filled out completely online using web-screens. An eTD that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTDs, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
(1)(a) Claims 23-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 10,307,480, issued 6/4/19 (cited on the 4/25/24 IDS), and which shares an inventor (Straub) and applicant with the instant application. Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons.
Instant independent claim 23 encompasses a method of treating a subject having a muscular dystrophy by administering an effective amount of an antibody that comprises a heavy chain sequence of SEQ ID NO: 25 and a light chain sequence of SEQ ID NO: 31.
Claim 10 of ‘480 encompasses a method of treating a myopathy in a subject comprising administering to the subject the pharmaceutical composition of claim 9, thereby treating the disorder. The composition of claim 9 comprises the antibody of claim 1, which encompasses an antibody comprising SEQ ID NO: 25 and 31, as evidenced by dependent claim 13, which recites an antibody comprising these sequences, which are identical to the SEQ ID NO: 25 and 31 of the instant application.
The specification of ‘480 defines the term “myopathy” as a “muscular disease in which the muscle fibers do not function properly” and provides examples of muscular myopathies that includes dystrophies (col 39, lines 41-47). Therefore, while the claims of ‘480 do not expressly recite that the myopathy is muscular dystrophy, the claims of ‘480 are properly construed as encompassing treatment of this condition. Per MPEP 804, “The portion of the specification of the reference that describes subject matter that falls within the scope of a reference claim may be relied upon to properly construe the scope of that claim”. As such, instant claim 23 is not patentably distinct from the claims of ‘480. Furthermore, per MPEP 804.II.B.2, “In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008); Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003).” In the instant case, treatment of a muscular dystrophy represents a disclosed utility of the product of the claims of the ‘480 patent. Thus, the instant claims are "nothing more than the earlier patent's disclosed utility as a method of using the compound" (MPEP 804.II.B.3), analogous to the fact pattern in Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC (2003), and thus the claims of the instant application are also not patentably distinct from those of the '480 patent based on the disclosed utility of the claimed product.
Claims 24 and 25 each limit the method of claim 23 by way of a wherein clause; each of which has been fully considered in context of the entire claim, but does not render the claimed method patentably distinct from a claim of another patent because each simply expresses the intended result of a process step positively recited. As such, claims 24 and 25 are also not patentably distinct from the claims of ‘480.
Claim 26 encompasses a method of claim 23 wherein the antibody inhibits activation of mature myostatin by tolloid protease with an IC50 of less than 1 µM. The claims of ‘480 do not expressly recite that the antibody of claim 1 has this property, but the specification of ‘480 teaches this property for antibodies of the invention (col 3, lines 56-58). As such, the claims of ‘480 are properly construed as encompassing use of an antibody having this further property. As such, claim 26 is also not patentably distinct from the claims of ‘480.
Claim 27 encompasses a method of claim 23 wherein the antibody comprises an IgG4 constant domain. This is also a property of the antibodies of claim 1 of ‘480, as evidenced by dependent claim 3, which further limits the antibody to comprising a constant domain selected from a group including IgG4. As such, claim 27 is also not patentably distinct from the claims of ‘480.
Claim 28 encompasses a method of claim 23 wherein the antibody is administered intravenously. While the claims of ‘480 do not expressly recite that the administered composition is administered intravenously, the specification of ‘480 teaches this route of administration for antibodies of the invention (e.g., col 5, lines 29-30). As such, the method step of the claims of ‘480 is properly construed as encompassing this route of administration. As such, claim 28 is also not patentably distinct from the claims of ‘480.
Claim 29 limits the method of claim 23 to one wherein the subject is treated with one or more additional therapies. While the claims of ‘480 do not expressly recite that the administered composition is includes additional therapies, the specification of ‘480 teaches that an effective amount includes combinations “with one or more other active agents” (e.g., col 41). As such, the method step of the claims of ‘480 is properly construed as encompassing inclusion of additional therapies; i.e., additional active agents. As such, claim 29 is also not patentably distinct from the claims of ‘480.
Claim 30 encompasses a method of claim 23 wherein the dystrophy is Duchenne’s. The specification of ‘480 further provides examples of muscular dystrophies to be treated, a group which includes Duchenne’s muscular dystrophy (col 41, lines 1-5). As such, claim 30 is also not patentably distinct from the claims of ‘480.
Claim 31 encompasses a method of claim 23 wherein the antibody comprises the heavy and light chain sequences of SEQ ID NO: 50 and 51. While the claims of ‘480 do not expressly recite that the antibody has the heavy and light chain sequences of SEQ ID NO: 50 and 51, the specification of ‘480 discloses these as an exemplary embodiment of an antibody of the invention comprising the CDRs recited in parent claim 1 (Figure 21; the Brief Description of Figure 21 in col 9-10; Table 1 in col 21). As such, the method step of the claims of ‘480 is properly construed as encompassing an antibody comprising these sequences, which are identical to the SEQ ID NO: 50 and 51 of the instant claims. As such, claim 31 is also not patentably distinct from the claims of ‘294.
(1)(b) Claims 23-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 73- of copending application 18/431,294, filed 2/2/24 and which shares an inventor (Straub) and applicant with the instant application. Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons.
Instant claims 23 and 30 each encompass a method of treating a subject having Duchenne muscular dystrophy by administering an effective amount of an antibody that comprises a heavy chain sequence of SEQ ID NO: 25 and a light chain sequence of SEQ ID NO: 31.
Claim 73 of the ‘294 application encompasses a method of treating a subject having Duchenne’s muscular dystrophy by administering an effective amount of an antibody comprising CDRH1-3 of SEQ ID NO: 1, 4 and 10, and CDRL1-3 of SEQ ID NO: 12, 18 and 22. While the claims of ‘294 do not expressly recite that the antibody has the heavy and light chain sequences of SEQ ID NO: 25 and 31, the specification of ‘294 discloses these as an exemplary embodiment of an antibody comprises these CDRs. As such, the method step of the claims of ‘294 is properly construed as encompassing an antibody comprising these sequences, which are identical to the SEQ ID NO: 25 and 31 of the instant claims. As such, claims 23 and 30 are also not patentably distinct from the claims of ‘294.
Claims 24 and 25 each limit the method of claim 23 by way of a wherein clause; each of which has been fully considered in context of the entire claim, but does not render the claimed method patentably distinct from a claim of another patent because each simply expresses the intended result of a process step positively recited. As such, claims 24 and 25 are also not patentably distinct from the claims of ‘294.
Claim 26 encompasses a method of claim 23 wherein the antibody inhibits activation of mature myostatin by tolloid protease with an IC50 of less than 1 µM. This corresponds to dependent claim 77 of ‘294. As such, claim 26 is also not patentably distinct from the claims of ‘294.
Claim 27 encompasses a method of claim 73 wherein the antibody comprises an IgG4 constant domain. This corresponds to dependent claim 78 of ‘294. As such, claim 27 is also not patentably distinct from the claims of ‘294.
Claim 28 encompasses a method of claim 23 wherein the antibody is administered intravenously. While the claims of ‘294 do not expressly recite that the administered composition is administered intravenously, the specification teaches this route of administration for antibodies of the invention (e.g., page 7). As such, the method step of the claims of ‘294 is properly construed as encompassing this route of administration. As such, claim 28 is also not patentably distinct from the claims of ‘294.
Claim 29 limits the method of claim 23 to one wherein the subject is treated with one or more additional therapies. While the claims of ‘294 do not expressly recite that the administered composition is includes additional therapies, the specification teaches that an effective amount includes combinations “with one or more other active agents”. As such, the method step of the claims of ‘294 is properly construed as encompassing inclusion of additional therapies; i.e., additional active agents. As such, claim 29 is also not patentably distinct from the claims of ‘294.
Claim 31 encompasses a method of claim 23 wherein the antibody comprises the heavy and light chain sequences of SEQ ID NO: 50 and 51. While the claims of ‘294 do not expressly recite that the antibody has the heavy and light chain sequences of SEQ ID NO: 50 and 51, the specification discloses these as an exemplary embodiment of an antibody that comprises the CDRs recited in claim 73 (Figure 21; the Brief Description of Figure 21 in col 9-10; Table 1 in col 21). As such, the method step of the claims of ‘294 is properly construed as encompassing an antibody comprising these sequences, which are identical to the SEQ ID NO: 50 and 51 of the instant claims. As such, claim 31 is also not patentably distinct from the claims of ‘294.
(2)(a) Claims 23-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 10,751,413, issued 8/25/20 (cited on the 4/25/24 IDS), and which shares two inventors (Donovan and Straub) and an applicant with the instant application. Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons.
Instant claims 23 and 31 encompass a method of treating a subject having a muscular dystrophy by administering an effective amount of an antibody that comprises a heavy and light chain sequence of SEQ ID NO: 50 and 51.
Claim 7 of ‘413 encompasses a method of treating a myopathy in a subject comprising administering to the subject an antibody of claim 1 in an amount effective to treat the disorder. The antibody of claim 1 encompasses an antibody comprising SEQ ID NO: 50 and 51. The specification of ‘513 defines the term “myopathy” as a “muscular disease in which the muscle fibers do not function properly” and provides examples of muscular myopathies that includes dystrophies (col 44). Therefore, while the claims of ‘513 do not expressly recite that the myopathy is muscular dystrophy, the claims of ‘480 are properly construed as encompassing treatment of this condition. Per MPEP 804, “The portion of the specification of the reference that describes subject matter that falls within the scope of a reference claim may be relied upon to properly construe the scope of that claim”. As such, claims 23 and 31 are not patentably distinct from the claims of ‘413. Furthermore, per MPEP 804.II.B.2, “In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008); Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003).” In the instant case, treatment of a muscular dystrophy represents a disclosed utility of the product of the claims of the ‘413 patent. Thus, the instant claims are "nothing more than the earlier patent's disclosed utility as a method of using the compound" (MPEP 804.II.B.3), analogous to the fact pattern in Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC (2003), and thus the claims of the instant application are also not patentably distinct from those of the '413 patent based on the disclosed utility of the claimed product.
Claims 24 and 25 each limit the method of claim 23 by way of a wherein clause; each of which has been fully considered in context of the entire claim, but does not render the claimed method patentably distinct from a claim of another patent because each simply expresses the intended result of a process step positively recited. As such, claims 24 and 25 are also not patentably distinct from the claims of ‘413.
Claim 26 encompasses a method of claim 23 wherein the antibody inhibits activation of mature myostatin by tolloid protease with an IC50 of less than 1 µM. The claims of ‘413 do not expressly recite that the antibody of claim 1 has this property, but the specification of ‘413 teaches this property for antibodies of the invention (col 43). As such, the claims of ‘413 are properly construed as encompassing use of an antibody having this further property. As such, claim 26 is also not patentably distinct from the claims of ‘413.
Claim 27 encompasses a method of claim 23 wherein the antibody comprises an IgG4 constant domain. This is also a property of the antibodies of claim 1 of ‘413, as evidenced by the description of Ab2 (SEQ ID NO: 50/51), described in the Brief Description of Figure 21 as comprising an IgG4 constant domain. As such, claim 27 is also not patentably distinct from the claims of ‘413.
Claim 28 encompasses a method of claim 23 wherein the antibody is administered intravenously. This corresponds to dependent claim 10 of the claims of ‘413. As such, claim 28 is also not patentably distinct from the claims of ‘413.
Claim 29 limits the method of claim 23 to one wherein the subject is treated with one or more additional therapies. While the claims of ‘413 do not expressly recite that the administered composition is includes additional therapies, the specification teaches that an effective amount includes combinations “with one or more other active agents” (e.g., col 46). As such, the method step of the claims of ‘413 is properly construed as encompassing inclusion of additional therapies; i.e., additional active agents. As such, claim 29 is also not patentably distinct from the claims of ‘413.
Claim 30 encompasses a method of claim 23 wherein the dystrophy is Duchenne’s. The specification of ‘480 further provides examples of muscular dystrophies to be treated, a group which includes Duchenne’s muscular dystrophy (col 4). Thus, the claims of ‘413 are properly construed as encompassing treatment of muscular dystrophy that is Duchenne’s. As such, claim 30 is also not patentably distinct from the claims of ‘413.
(2)(b) Claims 23-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 11,439,704, issued 9/13/22 (cited on the 4/25/24 IDS), and which shares two inventors (Donovan and Straub) and an applicant with the instant application. Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons.
Instant claims 23 and 31 encompass a method of treating a subject having a muscular dystrophy by administering an effective amount of an antibody that comprises heavy and light chain sequences of SEQ ID NO: 50 and 51.
Claim 1 of ‘704 encompasses a method of preventing muscle loss and/or reducing muscle atrophy in a subject by administering an effective amount of an antibody comprising heavy and light chain sequences of SEQ ID NO: 50 and 51. Dependent claim 2 further limits the muscle loss or atrophy to that caused by a condition selected from a group including muscular dystrophy. Thus the claims of the instant application are not patentably distinct from those of the '704 patent.
Claims 24 and 25 each limit the method of claim 23 by way of a wherein clause; each of which has been fully considered in context of the entire claim, but does not render the claimed method patentably distinct from a claim of another patent because each simply expresses the intended result of a process step positively recited. As such, claims 24 and 25 are also not patentably distinct from the claims of ‘704.
Claim 26 encompasses a method of claim 23 wherein the antibody inhibits activation of mature myostatin by tolloid protease with an IC50 of less than 1 µM. The claims of ‘704 do not expressly recite that the antibody of claim 1 has this property, but the specification teaches this property for antibodies of the invention (col 3). As such, the claims of ‘704 are properly construed as encompassing use of an antibody having this further property. As such, claim 26 is also not patentably distinct from the claims of ‘704.
Claim 27 encompasses a method of claim 23 wherein the antibody comprises an IgG4 constant domain. This is also a property of the antibodies of claim 1 of ‘704, as evidenced by the description of Ab2 (SEQ ID NO: 50/51), described in the Brief Description of Figure 21 as comprising an IgG4 constant domain. As such, claim 27 is also not patentably distinct from the claims of ‘704.
Claim 28 encompasses a method of claim 23 wherein the antibody is administered intravenously. This corresponds to dependent claim 8 of ‘704. As such, claim 28 is also not patentably distinct from the claims of ‘704.
Claim 29 limits the method of claim 23 to one wherein the subject is treated with one or more additional therapies. While the claims of ‘704 do not expressly recite that the administered composition is includes additional therapies, the specification teaches that an effective amount includes combinations “with one or more other active agents” (e.g., col 46). As such, the method step of the claims of ‘704 is properly construed as encompassing inclusion of additional therapies; i.e., additional active agents. As such, claim 29 is also not patentably distinct from the claims of ‘704.
Claim 30 encompasses a method of claim 23 wherein the dystrophy is Duchenne’s. This corresponds to dependent claims 3 or 6 of ‘704. As such, claim 30 is also not patentably distinct from the claims of ‘704.
(3)(a) Claims 23-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 10,287,345, issued 5/14/19 (cited on the 4/25/24 IDS), and which shares the same inventors and an applicant with the instant application. Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons.
The claims of ‘345 patent, which issued from parent application 15/400,825, to which the instant application claims priority as a continuation, are directed to the same invention as the instant claims. Specifically, the claims of the ‘345 patent encompasses a method for inhibiting myostatin activation comprising a step of administering an antibody comprising heavy and light chain variable regions of SEQ ID NO: 25 and 31 (claim 1, part (a)) and further wherein the subject has muscular dystrophy (dependent claim 3). Such a method is directed to the same invention as the instant claims, and thus the two sets of claims are not patentably distinct.
Claim 31 is directed to use of an antibody comprising heavy and light chain variable regions of SEQ ID NO: 50 and 51. While the claims of ‘345 do not expressly recite that the antibody has the heavy and light chain sequences of SEQ ID NO: 50 and 51, the specification discloses these as an exemplary embodiment of an antibody that comprises the CDRs recited in claim 1 (Figure 21; the Brief Description of Figure 21). As such, the method step of the claims of ‘345 is properly construed as encompassing an antibody comprising these sequences, which are identical to the SEQ ID NO: 50 and 51 of the instant claims. As such, claim 31 is also not patentably distinct from the claims of ‘294.
(3)(b) Claims 23-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 10,882,904, issued 1/5/21 (cited on the 4/25/24 IDS), and which shares the same inventors and an applicant with the instant application. Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons.
The claims of ‘904 patent, which issued from parent application 16/360,142, to which the instant application claims priority as a continuation, are directed to the same invention as the instant claims. Specifically, the claims of the ‘904 patent encompasses a method for inhibiting myostatin activation comprising a step of administering an antibody comprising heavy and light chain variable regions of SEQ ID NO: 50 and 51 (claim 1, part (a)) and further wherein the subject has muscular dystrophy (dependent claim 3). Such a method is directed to the same invention as the instant claims, and thus the two sets of claims are not patentably distinct.
(3)(c) Claims 23-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 12,006,359, issued 6/11/24 (cited on the 8/9/24 IDS), and which shares the same inventors and an applicant with the instant application. Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons.
The claims of ‘359 patent, which issued from parent application 17/083,917, to which the instant application claims priority as a continuation, are directed to the same invention as the instant claims. Specifically, the claims of the ‘359 patent encompasses a method for improving body composition comprising a step of administering an antibody comprising heavy and light chain variable regions of SEQ ID NO: 50 and 51 (claim 1, part (a)). Such a method is directed to the same invention as the instant claims, and thus the two sets of claims are not patentably distinct.
Conclusion
No claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZACHARY C HOWARD whose telephone number is (571)272-2877. The examiner can normally be reached on Monday to Friday from 9 AM to 5 PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Vanessa Ford, can be reached at telephone number (571) 272-0857. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ZACHARY C HOWARD/Primary Examiner, Art Unit 1674