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 .
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 09/02/2026 is acknowledged. Applicant also elected the following species: (i) the composition comprising a GDF8 inhibitor and a GLP-1 agonist; (ii) the GLP-1 receptor agonist semaglutide; (iii) an obesity related disorder; and (iv) the parameter of reducing fat mass.
Claim Status
Claims 3-5 are cancelled. Claims 1-2 and 6-37 are pending. Claims 2, 7-10, 14-15, 17-35, and 37 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 09/02/2026.
Claims 1, 6, 11-13, 16, and 36 are currently under consideration for patentability under 37 CFR 1.104.
Priority
This application claims benefit of Provisional U.S. Application Nos. 63/376,582 (filed on 09/21/2022) and 63/508,458 (filed on 06/15/2023). Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Claims 1, 6, 11-13, 16, and 36 have an effective filing date of 09/21/2022 corresponding to Provisional U.S. Application No. 63/376,582.
Information Disclosure Statement
The information disclosure statement(s) filed on 10/01/2024, 01/16/2026, and 07/22/2026 has/have been considered. Signed copies are enclosed. All references considered unless marked with strikethrough.
The information disclosure statement filed 10/01/2024 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered.
The information disclosure statement filed 10/01/2024 fails to comply with 37 CFR 1.98(a)(3)(i) because it does not include a concise explanation of the relevance, as it is presently understood by the individual designated in 37 CFR 1.56(c) most knowledgeable about the content of the information, of each reference listed that is not in the English language. It has been placed in the application file, but the information referred to therein has not been considered.
Notably, the disclosure statement filed on 10/01/2024 lists a Search Report. The listing of the references cited in a Search Report itself is not considered to be an information disclosure statement (IDS) complying with 37 CFR 1.98. 37 CFR 1.98(a)(2) requires a legible copy of: (1) each foreign patent; (2) each publication or that portion which caused it to be listed; (3) for each cited pending U.S. application, the application specification including claims, and any drawing of the application, or that portion of the application which caused it to be listed including any claims directed to that portion, unless the cited pending U.S. application is stored in the Image File Wrapper (IFW) system; and (4) all other information, or that portion which caused it to be listed. In addition, each IDS must include a list of all patents, publications, applications, or other information submitted for consideration by the Office (see 37 CFR 1.98(a)(1) and (b)), and MPEP § 609.04(a), subsection I. states, "the list ... must be submitted on a separate paper." Therefore, the references cited in the Search Report have not been considered. Applicant is advised that the date of submission of any item of information or any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the IDS, including all "statement" requirements of 37 CFR 1.97(e). See MPEP § 609.05(a).
Note: If copies of the individual references cited on the Search Report are also cited separately on the IDS (and these references have not been lined-through) they have been considered.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
Claim Objections
Claim 6 is objected to because of the following informalities: the extra space after “(HCDR1, HCDR2, and HCDR3)” should be removed.
Appropriate correction is required.
Claim Interpretation
Claim 16 recites the phrase “[t]he composition of claim 1 for use…” in the preamble, which is directed towards intended use in therapeutic applications. The recited intended uses do not hold patentable weight and are not limiting (MPEP 2111.02). For the purposes of claim interpretation, prior art disclosing the structural limitations of the composition of claim 1 will also read on claim 16.
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.
Claims 1, 6, 11-13, 16, and 36 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.
Regarding claim 1, the phrase "the heavy chain complementarity determining regions (HCDRs) of a heavy chain variable region (HCVR) comprising the amino acid sequence of SEQ ID NO:4, and the light chain complementarity determining regions (LCDRs) of a light chain variable region (LCVR) comprising the amino acid sequence of SEQ ID NO:5" renders the claim indefinite because it is unclear if (i) Applicant meant to recite the CDR sequences and failed to or (ii) Applicant did not intend to recite the CDR sequences and meant to only refer to the HCVR and LCVR sequences. Claims 1, 6, 11-13, 16, and 36 are included in this rejection as they incorporate and/or depend on claim 1.
For the purposes of claim interpretation, the phrase "the heavy chain complementarity determining regions (HCDRs) of a heavy chain variable region (HCVR) comprising the amino acid sequence of SEQ ID NO:4, and the light chain complementarity determining regions (LCDRs) of a light chain variable region (LCVR) comprising the amino acid sequence of SEQ ID NO:5" will be treated as "a heavy chain variable region (HCVR) comprising the amino acid sequence of SEQ ID NO:4 and a light chain variable region (LCVR) comprising the amino acid sequence of SEQ ID NO:5" i.e. only reference to the HCVR and LCVR sequences.
Regarding claim 11, the phrase "Exenatide (long-acting)” renders the claim indefinite because it is unclear whether the limitation in the parentheses of the phrase are part of the claimed invention. See MPEP § 2173.05(d).
For the purposes of claim interpretation, the limitation in the parentheses of the phrase will not be treated as part of the claimed invention.
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.
Claims 1, 6, 11-13, 16, and 36 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US20240368262A1 (effectively filed 06/23/2021, hereinafter referred to as US ‘262) as evidenced by US10526403B2 (published 01/07/2020, hereinafter referred to as US ‘403; IDS filed on 10/01/2024, Pg. 2, 19th citation).
Regarding instant claims 1 and 11-13, US ‘262 teaches a “an inhibitor of the myostatin [GDF8] signaling pathway and an activator of the GLP-1 signaling pathway… formulated in a single pharmaceutical composition” (¶ 0018; ¶ 0138, indicates myostatin is also known as GDF8). US ‘262 further teaches the myostatin (GDF8) signaling pathway inhibitor is “anti-myostatin antibodies” (¶ 0146) i.e. the GDF8 inhibitor is an anti-GDF8 antibody (instant claim 1). US ‘262 further teaches “the activators of the GLP-1 signaling pathway useful for carrying out the invention are GLP-1 receptor agonists (instant claims 1 and 11)… [including] semaglutide (instant claims 12-13)” (¶ 0026). These teachings read on a composition comprising an anti-GDF8 antibody as a GDF8 inhibitor (instant claim 1) and semaglutide (instant claims 12-13) as a GLP-1 receptor agonist (instant claims 1 and 11).
Regarding instant claim 16, the recited intended uses do not hold patentable weight and are not limiting (MPEP 2111.02; see also claim interpretation section). As the structural limitations of the composition of claim 1 are met as described above, these teachings also read on claim 16.
US ‘262 further teaches the anti-GDF8/myostatin antibody is “trevogrumab” (¶ 0016), also referred to as “REGN1033” (¶ 0025). The instant specification indicates another name of REGN1033 is H4H1657N2 (¶ 0091).
US ‘262 further teaches “when used in conjunction with a GLP-1 receptor agonist (e.g., GLP-1 analogs), a myostatin [GDF8] inhibitor can enhance overall weight loss” (¶ 0011), indicating it use in weight management.
US ‘262 does not explicitly teach the amino acid sequences comprising the anti-GDF8 antibody for the HCVR and LCVR as recited in instant claims 1 and 36 nor (ii) the 6 CDRs as recited in instant claim 6.
Regarding the amino acid sequences of instant claims 1, 6, and 36, US ‘403 teaches an anti-GDF8 antibody H4H1657N2 comprising SEQ ID NOs: 217 and 221 for the HCVR and LCVR respectively (column 6, lines 59-65, indicates sequences comprise H4H1657N2), identical to instant SEQ ID NOs: 4 and 5 (instant claims 1 and 36). SEQ ID NO: 217 comprises instant SEQ ID NOs: 6-8 for LCDR1, LCDR2, and LCDR3 respectively and SEQ ID NO: 221 comprises instant SEQ ID NO: 9, TTS, and instant SEQ ID NO: 11 for HCDR1, HCDR2, and HCDR3 respectively (instant claim 6). This teaching reads on the amino acid sequences comprising the anti-GDF8 antibody H4H1657N2 (also referred to as trevogrumab and REGN1033) are inherently (i) the HCVR and LCVR as recited in instant claims 1 and 36 and (ii) the 6 CDRs as recited in instant claim 6 as evidenced by US ‘403.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 6, 11-13, 16, and 36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 18 of U.S. Patent No. 10526403 (hereinafter referred to as US ‘403) in view of US20240368262A1 (effectively filed 06/23/2021, hereinafter referred to as US ‘262) as evidenced by the disclosure of U.S. Patent No. 10526403 (published 01/07/2020, hereinafter referred to as the disclosure of US ‘403; IDS filed on 10/01/2024, Pg. 2, 19th citation).
US ‘262 and US ‘403 are as discussed above and incorporated by reference herein. Instant claims 1, 6, 11-13, 16, and 36 are anticipated by the combined teachings of the prior art as fully described in the 102 rejection section, the 102s being incorporated here.
Instant claims 1 and 16 teach a composition comprising a GLP-1 agonist and GDF-8 inhibitor, wherein the GDF-8 inhibitor is an anti-GDF8 antibody comprising CDRs from HCVR and LCVR sequences of SEQ ID NOs: 4-5 (see claim interpretation for instant claim 16 as it is directed towards intended use). Instant claim 6 teaches the anti-GF8 antibody further comprises SEQ ID NOs: 6-8 for LCDR1, LCDR2, and LCDR3 respectively and SEQ ID NO: 9, TTS, and SEQ ID NO: 11 for HCDR1, HCDR2, and HCDR3 respectively. Instant claims 11-13 teach the GLP-1 agonist is a GLP-1 receptor agonist (instant claim 11), reciting specific drugs (instant claim 12) including semaglutide (instant claims 12-13). Instant claim 36 teaches the anti-GF8 antibody further comprises SEQ ID NOs: 4 and 5 for HCVR and LCVR respectively.
Claim 18 of US ‘403 teaches a pharmaceutical composition comprising an anti-Activin A antibody and an anti-GDF8 antibody comprising SEQ ID NOs: 217 and 221 for the HCVR and LCVR respectively, identical to instant SEQ ID NOs: 4 and 5 (instant claims 1, 16, and 36). SEQ ID NO: 217 comprises instant SEQ ID NOs: 6-8 for LCDR1, LCDR2, and LCDR3 respectively and SEQ ID NO: 221 comprises instant SEQ ID NO: 9, TTS, and instant SEQ ID NO: 11 for HCDR1, HCDR2, and HCDR3 respectively (instant claim 6). As amino acid sequences for the anti-GDF8 antibody of US ‘403 are 100% identical to the amino acid sequences of the instantly claimed anti-GDF8 antibody, this teaching reads on the amino acid sequences comprising the anti-GDF8 antibody comprising (i) the HCVR and LCVR as recited in instant claims 1, 16, and 36 and (ii) the 6 CDRs as recited in instant claim 6.
Claim 18 of US ‘403 does not teach the anti-GDF8 antibody is a GDF8 inhibitor (instant claim 1) nor the composition further comprises semaglutide (instant claims 12-13) as a GLP-1 receptor agonist (instant claims 1 and 11). These deficiencies are remedied by US ‘262 as evidenced by the disclosure of US ‘403.
A combination therapy comprising an inhibitory anti-GDF8 antibody and GLP-1 receptor agonist semaglutide was known and used prior to the effective filing date of the application. In addition, both US ‘403 and US ‘262 are in analogous arts (i.e. compositions comprising anti-GDF antibodies). Since US ‘262 teaches a GLP-1 agonist enhances weight loss in a subject when combined with an anti-GDF8 antibody, there is motivation for using the anti-GDF8 antibody as taught by claim 18 of US ‘403 in a combination therapy further comprising a GLP-1 agonist as taught by US ‘262 as evidenced by the disclosure of US ‘403 to treat overweight patients struggling with weight loss.
MPEP § 2141(III)(G) states a rationale that may support a conclusion of obviousness includes “[s]ome teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.” MPEP § 2143(I)(G) states this rationale should explain why “[a] person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and whether there would have been a reasonable expectation of success in doing so." DyStar Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick Co., 464 F.3d 1356, 1360, 80 USPQ2d 1641, 1645 (Fed. Cir. 2006).
The teaching, suggestion, or motivation in the prior art (i.e. US ‘262 teaches a GLP-1 agonist enhances weight loss in a subject when combined with an anti-GDF8 antibody) would have led one of ordinary skill to modify claim 18 of US ‘403 (i.e. a pharmaceutical composition comprising an anti-GDF8 antibody) to arrive at the claimed invention. There is a reasonable expectation of success as US ‘262 specifically mentions the anti-GDF8 antibody REGN1033 (also referred to as trevogrumab and H4H1657N2) can be combined with semaglutide, indicating this composition would have therapeutic benefits in weight management. The anti-GDF8 antibody REGN1033 inherently comprises the SEQ ID NOs of claim 18 of US ‘403 as evidenced by the disclosure of US ‘403.
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the instant application to use the anti-GDF8 antibody as taught by claim 18 of US ‘403 in a combination therapy further comprising a GLP-1 agonist as taught by US ‘262 as evidenced by the disclosure of US ‘403 to treat overweight patients struggling with weight loss.
Claims 1, 6, 11-13, 16, and 36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 48 of copending Application No. 18/059,315 (hereinafter referred to as copending ‘315) in view of US20240368262A1 (effectively filed 06/23/2021, hereinafter referred to as US ‘262) as evidenced by US10526403B2 (published 01/07/2020, hereinafter referred to as US ‘403; IDS filed on 10/01/2024, Pg. 2, 19th citation).
US ‘262 and US ‘403 are as discussed above and incorporated by reference herein. Instant claims 1, 6, 11-13, 16, and 36 are anticipated by the combined teachings of the prior art as fully described in the 102 rejection section, the 102s being incorporated here.
Instant claims 1 and 16 teach a composition comprising a GLP-1 agonist and GDF-8 inhibitor, wherein the GDF-8 inhibitor is an anti-GDF8 antibody comprising CDRs from HCVR and LCVR sequences of SEQ ID NOs: 4-5 (see claim interpretation for instant claim 16 as it is directed towards intended use). Instant claim 6 teaches the anti-GF8 antibody further comprises SEQ ID NOs: 6-8 for LCDR1, LCDR2, and LCDR3 respectively and SEQ ID NO: 9, TTS, and SEQ ID NO: 11 for HCDR1, HCDR2, and HCDR3 respectively. Instant claims 11-13 teach the GLP-1 agonist is a GLP-1 receptor agonist (instant claim 11), reciting specific drugs (instant claim 12) including semaglutide (instant claims 12-13). Instant claim 36 teaches the anti-GF8 antibody further comprises SEQ ID NOs: 4 and 5 for HCVR and LCVR respectively.
Claim 48 of copending ‘315 teaches a pharmaceutical composition comprising anti-Activin A antibody and an antagonistic anti-GDF8 antibody comprising SEQ ID NOs: 217 and 221 for the HCVR and LCVR respectively, identical to instant SEQ ID NOs: 4 and 5 (instant claims 1, 16, and 36). SEQ ID NO: 217 comprises instant SEQ ID NOs: 6-8 for LCDR1, LCDR2, and LCDR3 respectively and SEQ ID NO: 221 comprises instant SEQ ID NO: 9, TTS, and instant SEQ ID NO: 11 for HCDR1, HCDR2, and HCDR3 respectively (instant claim 6). As amino acid sequences for the anti-GDF8 antibody of copending ‘315 are 100% identical to the amino acid sequences of the instantly claimed anti-GDF8 antibody, this teaching reads on the amino acid sequences comprising the inhibitory anti-GDF8 antibody (i.e. antagonistic anti-GDF8 antibody) comprising (i) the HCVR and LCVR as recited in instant claims 1, 16, and 36 and (ii) the 6 CDRs as recited in instant claim 6.
Claim 48 of copending ‘315 does not teach the composition further comprises semaglutide (instant claims 12-13) as a GLP-1 receptor agonist (instant claims 1 and 11). These deficiencies are remedied by US ‘262 as evidenced by US ‘403.
A combination therapy comprising an inhibitory anti-GDF8 antibody and GLP-1 receptor agonist semaglutide was known and used prior to the effective filing date of the application. In addition, both copending ‘315, US ‘403, and US ‘262 are in analogous arts (i.e. compositions comprising anti-GDF antibodies). Since US ‘262 teaches a GLP-1 agonist enhances weight loss in a subject when combined with an anti-GDF8 antibody, there is motivation for using the anti-GDF8 antibody as taught by copending ‘315 in a combination therapy further comprising a GLP-1 agonist as taught by US ‘262 as evidenced by US ‘403 to treat overweight patients struggling with weight loss.
MPEP § 2141(III)(G) states a rationale that may support a conclusion of obviousness includes “[s]ome teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.” MPEP § 2143(I)(G) states this rationale should explain why “[a] person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and whether there would have been a reasonable expectation of success in doing so." DyStar Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick Co., 464 F.3d 1356, 1360, 80 USPQ2d 1641, 1645 (Fed. Cir. 2006).
The teaching, suggestion, or motivation in the prior art (i.e. US ‘262 teaches a GLP-1 agonist enhances weight loss in a subject when combined with an anti-GDF8 antibody) would have led one of ordinary skill to modify copending ‘315 (i.e. a pharmaceutical composition comprising an anti-GDF8 antibody) to arrive at the claimed invention. There is a reasonable expectation of success as US ‘262 specifically mentions the anti-GDF8 antibody REGN1033 (also referred to as trevogrumab and H4H1657N2) can be combined with semaglutide, indicating this composition would have therapeutic benefits in weight management. The anti-GDF8 antibody REGN1033 inherently comprises the SEQ ID NOs of copending ‘315 as evidenced by US ‘403.
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the instant application to use the anti-GDF8 antibody as taught by copending ‘315 in a combination therapy further comprising a GLP-1 agonist as taught by US ‘262 as evidenced by US ‘403 to treat overweight patients struggling with weight loss.
This is a provisional nonstatutory double patenting rejection.
Claims 1, 6, 11-13, 16, and 36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 15 of U.S. Patent No. 9718881 (hereinafter referred to as Pat. ‘881) in view of US20240368262A1 (effectively filed 06/23/2021, hereinafter referred to as US ‘262) as evidenced by US10526403B2 (published 01/07/2020, hereinafter referred to as US ‘403; IDS filed on 10/01/2024, Pg. 2, 19th citation).
US ‘262 and US ‘403 are as discussed above and incorporated by reference herein. Instant claims 1, 6, 11-13, 16, and 36 are anticipated by the combined teachings of the prior art as fully described in the 102 rejection section, the 102s being incorporated here.
Instant claims 1 and 16 teach a composition comprising a GLP-1 agonist and GDF-8 inhibitor, wherein the GDF-8 inhibitor is an anti-GDF8 antibody comprising CDRs from HCVR and LCVR sequences of SEQ ID NOs: 4-5 (see claim interpretation for instant claim 16 as it is directed towards intended use). Instant claim 6 teaches the anti-GF8 antibody further comprises SEQ ID NOs: 6-8 for LCDR1, LCDR2, and LCDR3 respectively and SEQ ID NO: 9, TTS, and SEQ ID NO: 11 for HCDR1, HCDR2, and HCDR3 respectively. Instant claims 11-13 teach the GLP-1 agonist is a GLP-1 receptor agonist (instant claim 11), reciting specific drugs (instant claim 12) including semaglutide (instant claims 12-13). Instant claim 36 teaches the anti-GF8 antibody further comprises SEQ ID NOs: 4 and 5 for HCVR and LCVR respectively.
Claim 15 of Pat. ‘881 teaches a pharmaceutical composition comprising anti-Activin A antibody and an antagonistic anti-GDF8 antibody comprising SEQ ID NOs: 217 and 221 for the HCVR and LCVR respectively, identical to instant SEQ ID NOs: 4 and 5 (instant claims 1, 16, and 36). SEQ ID NO: 217 comprises instant SEQ ID NOs: 6-8 for LCDR1, LCDR2, and LCDR3 respectively and SEQ ID NO: 221 comprises instant SEQ ID NO: 9, TTS, and instant SEQ ID NO: 11 for HCDR1, HCDR2, and HCDR3 respectively (instant claim 6). As amino acid sequences for the anti-GDF8 antibody of Pat. ‘881 are 100% identical to the amino acid sequences of the instantly claimed anti-GDF8 antibody, this teaching reads on the amino acid sequences comprising the inhibitory anti-GDF8 antibody (i.e. antagonistic anti-GDF8 antibody) comprising (i) the HCVR and LCVR as recited in instant claims 1, 16, and 36 and (ii) the 6 CDRs as recited in instant claim 6.
Claim 15 of Pat. ‘881 does not teach the composition further comprises semaglutide (instant claims 12-13) as a GLP-1 receptor agonist (instant claims 1 and 11). These deficiencies are remedied by US ‘262 as evidenced by US ‘403.
A combination therapy comprising an inhibitory anti-GDF8 antibody and GLP-1 receptor agonist semaglutide was known and used prior to the effective filing date of the application. In addition, Pat. ‘881, US ‘403 and US ‘262 are in analogous arts (i.e. compositions comprising anti-GDF antibodies). Since US ‘262 teaches a GLP-1 agonist enhances weight loss in a subject when combined with an anti-GDF8 antibody, there is motivation for using the anti-GDF8 antibody as taught by Pat. ‘881 in a combination therapy further comprising a GLP-1 agonist as taught by US ‘262 as evidenced by US ‘403 to treat overweight patients struggling with weight loss.
MPEP § 2141(III)(G) states a rationale that may support a conclusion of obviousness includes “[s]ome teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.” MPEP § 2143(I)(G) states this rationale should explain why “[a] person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and whether there would have been a reasonable expectation of success in doing so." DyStar Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick Co., 464 F.3d 1356, 1360, 80 USPQ2d 1641, 1645 (Fed. Cir. 2006).
The teaching, suggestion, or motivation in the prior art (i.e. US ‘262 teaches a GLP-1 agonist enhances weight loss in a subject when combined with an anti-GDF8 antibody) would have led one of ordinary skill to modify Pat. ‘881 (i.e. a pharmaceutical composition comprising an anti-GDF8 antibody) to arrive at the claimed invention. There is a reasonable expectation of success as US ‘262 specifically mentions the anti-GDF8 antibody REGN1033 (also referred to as trevogrumab and H4H1657N2) can be combined with semaglutide, indicating this composition would have therapeutic benefits in weight management. The anti-GDF8 antibody REGN1033 inherently comprises the SEQ ID NOs of Pat. ‘881 as evidenced by US ‘403.
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the instant application to use the anti-GDF8 antibody as taught by Pat. ‘881 in a combination therapy further comprising a GLP-1 agonist as taught by US ‘262 as evidenced by US ‘403 to treat overweight patients struggling with weight loss.
Claims 1, 6, 11-13, 16, and 36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4-5 of U.S. Patent No. 8840894 (hereinafter referred to as Pat. ‘894) in view of US20240368262A1 (effectively filed 06/23/2021, hereinafter referred to as US ‘262) as evidenced by the US10526403B2 (published 01/07/2020, hereinafter referred to as US ‘403; IDS filed on 10/01/2024, Pg. 2, 19th citation).
US ‘262 and US ‘403 are as discussed above and incorporated by reference herein. Instant claims 1, 6, 11-13, 16, and 36 are anticipated by the combined teachings of the prior art as fully described in the 102 rejection section, the 102s being incorporated here.
Instant claims 1 and 16 teach a composition comprising a GLP-1 agonist and GDF-8 inhibitor, wherein the GDF-8 inhibitor is an anti-GDF8 antibody comprising CDRs from HCVR and LCVR sequences of SEQ ID NOs: 4-5 (see claim interpretation for instant claim 16 as it is directed towards intended use). Instant claim 6 teaches the anti-GF8 antibody further comprises SEQ ID NOs: 6-8 for LCDR1, LCDR2, and LCDR3 respectively and SEQ ID NO: 9, TTS, and SEQ ID NO: 11 for HCDR1, HCDR2, and HCDR3 respectively. Instant claims 11-13 teach the GLP-1 agonist is a GLP-1 receptor agonist (instant claim 11), reciting specific drugs (instant claim 12) including semaglutide (instant claims 12-13). Instant claim 36 teaches the anti-GF8 antibody further comprises SEQ ID NOs: 4 and 5 for HCVR and LCVR respectively.
Claims 1 and 4 of Pat. ‘894 teach an isolated anti-GDF8 antibody that blocks GDF9 binding (i.e. it is inhibitory) comprising SEQ ID NOs: 360 and 368 for the HCVR and LCVR respectively, identical to instant SEQ ID NOs: 4 and 5 (instant claims 1, 16, and 36). SEQ ID NO: 360 comprises instant SEQ ID NOs: 6-8 for LCDR1, LCDR2, and LCDR3 respectively and SEQ ID NO: 368 comprises instant SEQ ID NO: 9, TTS, and instant SEQ ID NO: 11 for HCDR1, HCDR2, and HCDR3 respectively (instant claim 6). As amino acid sequences for the anti-GDF8 antibody of Pat. ‘894 are 100% identical to the amino acid sequences of the instantly claimed anti-GDF8 antibody, this teaching reads on the amino acid sequences comprising the inhibitory anti-GDF8 antibody comprising (i) the HCVR and LCVR as recited in instant claims 1, 16, and 36 and (ii) the 6 CDRs as recited in instant claim 6.
Claim 5 of Pat. ‘894 teaches the anti-GDF8 antibody in a pharmaceutical composition (instant claim 1).
Claims 1 and 4-5 of Pat. ‘894 do not teach the composition further comprises semaglutide (instant claims 12-13) as a GLP-1 receptor agonist (instant claims 1 and 11). These deficiencies are remedied by US ‘262 as evidenced by US ‘403.
A combination therapy comprising an inhibitory anti-GDF8 antibody and GLP-1 receptor agonist semaglutide was known and used prior to the effective filing date of the application. In addition, Pat. ‘894, US ‘403 and US ‘262 are in analogous arts (i.e. compositions comprising anti-GDF antibodies). Since US ‘262 teaches a GLP-1 agonist enhances weight loss in a subject when combined with an anti-GDF8 antibody, there is motivation for using the anti-GDF8 antibody as taught by Pat. ‘894 in a combination therapy further comprising a GLP-1 agonist as taught by US ‘262 as evidenced by US ‘403 to treat overweight patients struggling with weight loss.
MPEP § 2141(III)(G) states a rationale that may support a conclusion of obviousness includes “[s]ome teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.” MPEP § 2143(I)(G) states this rationale should explain why “[a] person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and whether there would have been a reasonable expectation of success in doing so." DyStar Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick Co., 464 F.3d 1356, 1360, 80 USPQ2d 1641, 1645 (Fed. Cir. 2006).
The teaching, suggestion, or motivation in the prior art (i.e. US ‘262 teaches a GLP-1 agonist enhances weight loss in a subject when combined with an anti-GDF8 antibody) would have led one of ordinary skill to modify Pat. ‘894 (i.e. a pharmaceutical composition comprising an anti-GDF8 antibody) to arrive at the claimed invention. There is a reasonable expectation of success as US ‘262 specifically mentions the anti-GDF8 antibody REGN1033 (also referred to as trevogrumab and H4H1657N2) can be combined with semaglutide, indicating this composition would have therapeutic benefits in weight management. The anti-GDF8 antibody REGN1033 inherently comprises the SEQ ID NOs of Pat. ‘894 as evidenced by US ‘403.
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the instant application to use the anti-GDF8 antibody as taught by Pat. ‘894 in a combination therapy further comprising a GLP-1 agonist as taught by US ‘262 as evidenced by US ‘403 to treat overweight patients struggling with weight loss.
Claims 1, 6, 11-13, 16, and 36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4-6 of U.S. Patent No. 9890212 (hereinafter referred to as Pat. ‘212) in view of US20240368262A1 (effectively filed 06/23/2021, hereinafter referred to as US ‘262) as evidenced by the US10526403B2 (published 01/07/2020, hereinafter referred to as US ‘403; IDS filed on 10/01/2024, Pg. 2, 19th citation).
US ‘262 and US ‘403 are as discussed above and incorporated by reference herein. Instant claims 1, 6, 11-13, 16, and 36 are anticipated by the combined teachings of the prior art as fully described in the 102 rejection section, the 102s being incorporated here.
Instant claims 1 and 16 teach a composition comprising a GLP-1 agonist and GDF-8 inhibitor, wherein the GDF-8 inhibitor is an anti-GDF8 antibody comprising CDRs from HCVR and LCVR sequences of SEQ ID NOs: 4-5 (see claim interpretation for instant claim 16 as it is directed towards intended use). Instant claim 6 teaches the anti-GF8 antibody further comprises SEQ ID NOs: 6-8 for LCDR1, LCDR2, and LCDR3 respectively and SEQ ID NO: 9, TTS, and SEQ ID NO: 11 for HCDR1, HCDR2, and HCDR3 respectively. Instant claims 11-13 teach the GLP-1 agonist is a GLP-1 receptor agonist (instant claim 11), reciting specific drugs (instant claim 12) including semaglutide (instant claims 12-13). Instant claim 36 teaches the anti-GF8 antibody further comprises SEQ ID NOs: 4 and 5 for HCVR and LCVR respectively.
Claims 1 and 5 of Pat. ‘212 teach an isolated anti-GDF8 antibody that blocks GDF9 binding (i.e. it is inhibitory) comprising SEQ ID NOs: 360 and 368 for the HCVR and LCVR respectively, identical to instant SEQ ID NOs: 4 and 5 (instant claims 1, 16, and 36).
Claim 4 of Pat. ‘212 teaches the anti-GDF8 antibody in a pharmaceutical composition (instant claim 1).
Claim 6 of Pat. ‘212 teaches SEQ ID NOs: 362, 364, and 366 for HCDR1, HCDR2, and HCDR3 and SEQ ID NOs: 370, 372, and 374, identical to the CDR sequences recited in instant claim 6.
Claims 1 and 4-6 of Pat. ‘212 do not teach the composition further comprises semaglutide (instant claims 12-13) as a GLP-1 receptor agonist (instant claims 1 and 11). These deficiencies are remedied by US ‘262 as evidenced by US ‘403.
A combination therapy comprising an inhibitory anti-GDF8 antibody and GLP-1 receptor agonist semaglutide was known and used prior to the effective filing date of the application. In addition, Pat. ‘212, US ‘403 and US ‘262 are in analogous arts (i.e. compositions comprising anti-GDF antibodies). Since US ‘262 teaches a GLP-1 agonist enhances weight loss in a subject when combined with an anti-GDF8 antibody, there is motivation for using the anti-GDF8 antibody as taught by Pat. ‘212 in a combination therapy further comprising a GLP-1 agonist as taught by US ‘262 as evidenced by US ‘403 to treat overweight patients struggling with weight loss.
MPEP § 2141(III)(G) states a rationale that may support a conclusion of obviousness includes “[s]ome teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.” MPEP § 2143(I)(G) states this rationale should explain why “[a] person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and whether there would have been a reasonable expectation of success in doing so." DyStar Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick Co., 464 F.3d 1356, 1360, 80 USPQ2d 1641, 1645 (Fed. Cir. 2006).
The teaching, suggestion, or motivation in the prior art (i.e. US ‘262 teaches a GLP-1 agonist enhances weight loss in a subject when combined with an anti-GDF8 antibody) would have led one of ordinary skill to modify Pat. ‘212 (i.e. a pharmaceutical composition comprising an anti-GDF8 antibody) to arrive at the claimed invention. There is a reasonable expectation of success as US ‘262 specifically mentions the anti-GDF8 antibody REGN1033 (also referred to as trevogrumab and H4H1657N2) can be combined with semaglutide, indicating this composition would have therapeutic benefits in weight management. The anti-GDF8 antibody REGN1033 inherently comprises the SEQ ID NOs of Pat. ‘212 as evidenced by US ‘403.
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the instant application to use the anti-GDF8 antibody as taught by Pat. ‘212 in a combination therapy further comprising a GLP-1 agonist as taught by US ‘262 as evidenced by US ‘403 to treat overweight patients struggling with weight loss.
Conclusion
Claims 1, 6, 11-13, 16, and 36 currently under consideration for patentability under 37 CFR 1.104. Claim 6 is objected to. Claims 1, 6, 11-13, 16, and 36 are rejected. No claims are allowed.
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/J.M.P./Examiner, Art Unit 1642
/SAMIRA J JEAN-LOUIS/Supervisory Patent Examiner, Art Unit 1642
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