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 .
The amendment of 8/27/25 has been entered in full. Claims 13 and 27 are canceled. Claims 1, 5-6, 10-11, 25, 28, 85, 93-94, 96, 104 and 105 are amended. Claims 1-3, 5-11, 25, 28, 85-87 and 93-105 are pending.
Election/Restrictions
The following elections, made without traverse in the 8/27/25 reply, are acknowledged: (1) resistance training as the species of exercise regimen; (2) an antibody comprising the HCDRs/LCDRs of the VH/VL of SEQ ID NO: 360/368 as the species of GDF-8 inhibitor; (3) a subject that has or is at risk of loss of lean muscle mass as the species of condition; and (4) additional anti-GDF-8 antibody or antigen binding fragment as the species of additional therapeutic. Applicants indicate that the species read on all claims except 93 and 94. Claim(s) 93-94 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species of condition, there being no allowable generic or linking claim.
Claims 1-3, 5-11, 25, 28, 85-87 and 95-105 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 (1) the claims are directed to increasing lean body mass, but the title indicates the method is for increasing strength and functionality, (2) the claims are limited to the use of anti-GDF8 antibody, but the title is directed to any GDF8 inhibitor, and (3) the claims require providing an exercise regimen. A new title is required that is clearly indicative of the invention to which the claims are directed. The following title is suggested: “METHODS FOR INCREASING LEAN BODY MASS WITH AN EXERCISE REGIMEN AND A GDF8 INHIBITOR THAT IS AN ANTI-GDF8 ANTIBODY".
Appropriate correction is required.
Claim Objections
Claims 11 and 85 are objected to because of the following informalities:
In claim 11, line 4, “(HCVR)amino” should be “(HCVR) amino”.
In claim 85, “age related” should be “age-related”. Cf. parent claim 1.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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.
Claim 102 is 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 pre-AIA the applicant regards as the invention.
Claim 102 recites the limitation “the disease, disorder, or condition” in line 1. There is insufficient antecedent basis for this limitation in the claim. Specifically, claim 102 depends from claim 93, from which the limitation directed to “the disease, disorder, or condition” has been deleted in the most recent amendments to the claims. As such, the limitation in dependent claim 102 no longer has antecedent basis.
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 35 U.S.C. 112 (pre-AIA ), fourth paragraph:
Subject to the [fifth paragraph of 35 U.S.C. 112 (pre-AIA )], 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 11 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.
Per MPEP 608.01(n).III, “If the dependent claim does not comply with the requirements of 35 U.S.C. 112(d), the examiner should reject the dependent claim under 35 U.S.C. 112(d) rather than objecting to the claim” and “a dependent claim must be rejected under 35 U.S.C. 112(d) if it omits an element from the claim upon which it depends or it fails to add a limitation to the claim upon which it depends”.
Specifically, dependent claim 11 limits the method of claim 1 to one wherein the antibody or antigen binding fragment comprises three heavy chain CDRs (HCDR1-3) contained within the heavy chain variable region (HCVR) of SEQ ID NO: 360 and three light chain CDRs (LCDR1-3) contained with the light chain variable region (LCVR) of SEQ ID NO: 368. However, parent claim 1 already limits the inhibitor to an antibody comprising the HCDRs within the HCVR comprising SEQ ID NO: 360 and the LCDRs within the LCVR comprising SEQ ID NO: 368, and said HCVR and LCVR only contain three CDRs each. Therefore, dependent claim 11 is of improper dependent form because it fails to further limit the subject matter of parent claim 1.
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.
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.
Claims 1-3, 5-11, 25, 28, 85-87 and 95-105 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Patent No. 10,934,349, issued 3/2/21 (cited on the 8/27/24 IDS), and which shares the same inventors with the instant application. Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons.
The instant application claims priority as a continuation to application 17/149,540, which in turn claims priority as a continuation to application 15/099,701, from which the ‘349 patent issued.
Instant claim 1 encompasses a method for increasing lean body mass in a subject having or at risk of loss of lean muscle comprising two steps: the first of which is providing an exercise regimen comprising resistance training for the subject, and the second of which is administering a composition comprising an effective amount of a GDF-8 inhibitor that is an antibody that specifically binds GDF-8, and comprising the HCDRs of the HCVR of SEQ ID NO: 360 and the LCDRs of the LCVR of SEQ ID NO: 368.
Claim 1 of ‘349 encompasses the same invention, being directed to a method for increasing lean body mass in a subject comprising two steps: providing an exercise regimen comprising resistance training for the subject, and administering a composition comprising an effective amount of a GDF-8 inhibitor to the subject that is an antibody that specifically binds GDF-8, and comprising the HCDRs of the HCVR of SEQ ID NO: 360 and the LCDRs of the LCVR of SEQ ID NO: 368, wherein the subject exhibits increased lean body mass compared to baseline value. Thus, claim of 1 of ‘349 is broader than the instant claim, as it does not require that the subject has or is at risk of loss of lean muscle. However, dependent 18 of ‘399 further limits the subject to one experiencing age-related loss of lean muscle mass, which is encompassed by the “having…loss of lean muscle mass” of instant claim 1. As such, the claims of ‘349 include embodiments encompassed by the instant claims, and therefore the two sets of claims are not patentably distinct.
Instant claims 2-3, 6-11, 25, 28, 85-87, 93, 97 and 104 depend from claim 1 and each further limit the method to embodiments that correspond to the further limitations of the method of dependent claims of ‘349 in the following manner:
Instant Claim
Claim of ‘349
2
2
3
3
6
5
7
6
8
7
9
8
10
1
11
1
25
16
28
9
85
18
86
19
87
20
93
18
97
22
103
23
104
21
As such, each dependent claim is not patentably distinct from the claims of ‘349 because each further embodiment is expressly recited as part of the claimed invention of ‘349.
Claims 5, 96, 98-102 and 105 each depend from claim 1 and further narrow the scope of the limit. While the claims of ‘349 do not expressly recite these further embodiments, the method of the claims ‘349 is properly construed as encompassing each of these embodiments, because the instant application is a continuation of the parent application, and therefore contains an identical disclosure that informs the embodiments encompassed by the method. Therefore, as the claims of each are directed to the same invention, the further embodiments of these claims are not patentably distinct from the claims ‘349.
Claims 1-3, 5-11, 25, 28, 85-87 and 95-105 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 12,029,788, issued 7/9/24 (cited on the 8/27/24 IDS), and which shares the same inventors with the instant application. Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons.
The instant application claims priority as a continuation to application 17/149,540, from which the ‘788 patent issued.
Instant independent claim 1 has a scope as set forth above.
Claim 1 of ‘788 encompasses the same invention, being directed to a method for increasing lean body mass in a subject experiencing or at risk of age-related loss of lean muscle mass and/or a disease, disorder or condition associated with a decrease in skeletal muscle comprising two steps: providing an exercise regimen comprising resistance training for the subject, and administering a composition comprising an effective amount of a GDF-8 inhibitor to the subject that is an antibody or antigen binding fragment that specifically binds GDF-8. Thus, claim of 1 of ‘349 is directed to a narrower subject population in the alternative, being limited to “age-related” loss of lean muscle mass, but is broader in scope with respect to the anti-GDF8 antibody to be administered. However, dependent claim 9 further limits the method of claim 1 to one wherein the antibody has the CDRs selected from a HCVR/LCVR pair selected from a group including SEQ ID NO: 360/368. As such, the claims of ‘349 include embodiments encompassed by the instant claims, and therefore the two sets of claims are not patentably distinct.
Instant claims 2-3, 6-11, 25, 28, 85-87, 93 and 96-104 depend from claim 1 and each further limit the method to embodiments that correspond to the further limitations of the method of dependent claims of ‘788 in the following manner:
Instant Claim
Claim of ‘788
2
2
3
3
6
4
7
5
8
6
9
7
10
1
11
1
25
11
28
9
85
1, 13
86
14
87
15
93
1, 13
96
18
97
19
98
21
99
22
100
23
101
24
102
25
103
20
104
26
As such, each dependent claim is not patentably distinct from the claims of ‘788 because each further embodiment is expressly recited as part of the claimed invention of ‘788.
Claims 5 and 105 each depend from claim 1 and further narrow the scope of the limit. While the claims of ‘788 do not expressly recite these further embodiments, the method of the claims ‘788 is properly construed as encompassing each of these embodiments, because the instant application is a continuation of the parent application, and therefore contains an identical disclosure that informs the embodiments encompassed by the method. Therefore, as the claims of each are directed to the same invention, the further embodiments of these claims are not patentably distinct from the claims of ‘788.
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
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