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 .
Action Mailed February 27, 2026, is Vacated
The Supplemental Reply filed 2/24/2026 was submitted after the Final Rejection was already prepared by the Examiner, and after the expiration of the deadline provided by the Examiner for responding to the Interview of 2/17/2026 (see Interview Summary with receipt date of 2/27/2026). A response was due prior to 2/20/2026, and Examiner did not receive any communications from Applicant requesting an extension or otherwise noting that a response would be filed. Accordingly, the Examiner prepared and submitted the Final prior to the "Receipt date" shown in the file wrapper (see Final with Receipt date of 2/27/2026).
The action mailed February 27, 2026, is vacated. The instant Action is Final.
The Supplemental was treated by the docketing system as an After-Final amendment by the USPTO. The instant issue corrects that issue. Therefore, upon reconsideration, the Final mailed 2/27/2026 is vacated and replaced by the instant action. The instant action is Final and considers the Supplemental response filed 2/24/2026 in view of the Action with the receipt date of 2/27/2026.
The Supplemental corrects illegible figures at claim 10, which confirms that the structures were properly treated in the Action dated 2/27/2026, and overcomes a prior objection to claim 10. The Supplemental cancels claims 4 and 6, which overcomes rejections under 35 USC §112(b) and §112(d) set forth in the Action dated 2/27/2026. The Supplemental does not address the prior art rejection under 35 USC 103 or the provisional NSDP rejection set forth in the vacated Action dated 2/27/2026, which is maintained as revised in view of the supplemental response filed 2/24/2027 in the instant action.
Claim Status
The claim set filed 2/24/2026 is considered. Claims 1-3, 7, and 9-14 are pending. Claim 14 remains withdrawn as directed to a non-elected invention, but is eligible for rejoinder. Claims 1-3, 7, and 9-13 are presently considered.
Election/Restrictions
Applicant's election with traverse of Group I (products) and the species of “Compound 13 of claim 11 (i.e., SEQ ID NO: 13 of claim 9)” in the reply filed on 8/15/2025 was previously considered but not found persuasive for reasons of record (see, e.g., Action mailed 9/25/2025 at 2-3, incorporated herein). The requirement was deemed proper and was therefore made FINAL.
The originally elected species was understood to read upon previously pending claims 5 and 9-11, but not previously pending claims 1-4, 6-8, or 12-13 for reasons of record (see, e.g., Action mailed 9/25/2025 at 2-3, incorporated herein). Following the amendments filed 12/23/2025 and in the supplemental filed 2/24/2026, the originally elected species1 is understood to read upon newly amended claims 1-3, 7, and 9-14.
Following extensive search and examination, the originally elected species was previously deemed free of the prior art. Per MPEP § 803.02(III), examination was extended to non-elected species compounds 1-5 and 13-14 as set forth at amended claim 11 (corresponding to instant SEQ ID NOs: 1-5 and 13-14) which were previously deemed free of the prior art. These species have been reevaluated in the instant action, and have again been deemed free of the prior art because they share a novel combination of positions and limitations with the originally elected species as shown below:
H[Aib,D-Ser]QGTFTSDKSKYLE[Aib]KAAQDFVEWLKAGGPSSGAPPPS
Residues shown in brackets are alternatives at a single position or Aib. Underlined Lys indicates position 10, which is linked to specific species of lipophilic moieties via specific bridging groups. The highlighted “E” and “KA” represents a Glu, Lys and Ala at positions 15, 27 and 28, respectively. Accordingly, SEQ ID NOs: 1-5 and 13-14 have again been deemed free of the prior art.
Per MPEP § 803.02(III), examination was previously extended to the non-elected species of SEQ ID NO: 72, which was subsequently deemed obvious in view of the prior art of record (see, e.g., Action mailed 9/25/2025 at 2-3, incorporated herein). Subsequently, amendments were filed in the Reply of 12/23/2025 and 2/24/2026 amending claim 1 to require a subgeneric structure of
H[Aib,S,DS]QGTFTSDKSKYL[D,E][Aib,E][K,R]AAQ[D,E]F[V,Iva][E,Q]WLKAGGPSSG[A,Aib]PPPS
wherein residues shown in brackets are alternatives at a single position, the underlined Lys indicates potential attachment points for a lipophilic moiety via a bridging group, and the highlighted “KA” represents a Lys and Ala at positions 27 and 28. These amendments excluded the non-elected species of SEQ ID NO: 7 (positions Xaa27-Xaa28 of “LE” are now excluded from the scope of claim 1) and SEQ ID NOs: 6, 8-12, and 15-16 (e.g., positions Xaa27-Xaa28 of “LD” are now excluded from the scope of claim 1) from the pending claim scope.
Any prior statements regarding allowability of SEQ ID NOs: 6, 8-12, and 15-16 was previously withdrawn as premature in the Action mailed 2/27/2026. That statement is maintained.
Accordingly, per MPEP § 803.02(III), examination was then extended to additional non-elected species within the scope of amended claim 1. As noted above, amended claim 1 as filed 12/23/2025 now reads upon all species within the subgenus of:
H[Aib,S,DS]QGTFTSDKSKYL[D,E][Aib,E][K,R]AAQ[D,E]F[V,Iva][E,Q]WLKAGGPSSG[A,Aib]PPPS
Examination has now been extended to species within a non-elected subgenus of presumably patentably indistinct and functionally equivalent species of 39-mer oxyntomodulin analogues, namely the species having the form of
H[Aib,DS]QGTFTSDKSKYLD[Aib,E][K,R]AAQ[D,E]FV[E,Q]WLKAGGPSSGAPPPS
wherein brackets indicate alternative residues at a single position, and wherein the underlined Lysine at position 10 is conjugated to CH3(CH2)10-24CO- or HOOC(CH2)10-24CO-, via a bridging group of either (PEG)2-10 or Asp-(PEG)2-10. Following extensive search and examination, the species within this subgenus were deemed obvious in view of the prior art applied below under 35 USC §103.
No claims are indicated as allowable at this time in view of remaining NSDP issues, as set forth on record below.
Claim 14 remains withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 8/15/2025.
Claims 1-3, 7, and 9-13 are presently considered.
Priority
The priority claim to CN202010113888.5 9 (filed 2/24/2020) is acknowledged.
Information Disclosure Statement
No IDS was filed in the reply submitted 12/23/2025 or 2/24/2026.
Specification
The Substitute Specification filed 12/23/2025 is acknowledged.
Drawings
The corrected drawings filed 12/23/2025 were previously acknowledged and accepted.
Withdrawn Claim Rejections
All prior rejections in the Action dated 9/25/2025 are withdrawn in view of the 2/24/2026 and 12/23/2025.
New Claim Rejections, as Necessitated by Applicant Amendment
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3, 10, and 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over US20170183383A13 (Jun 29, 2017) in view of WO2010/011439A2 (Jan. 28, 2010).
Regarding instant claims 1-3, 10, and 12-13, US’383 teaches and discloses a subgenus comprising species of oxyntomodulin analogues including 39-mer oxyntomodulin analogue species of the form
His-Xaa2-Gln-Gly-Thr-Phe-Thr-Ser-Asp-Xaa10-Ser-Lys-Xaa13-Leu-Asp-Xaa16-Xaa17-Xaa18-Ala-Xaa20-Xaa21-Phe-Xaa23-Xaa24-Trp-Leu-Xaa27-Xaa28-Xaa29-Xaa30-Xaa31-Xaa32-Xaa33-Xaa34-Xaa35-Xaa36-Xaa37-Xaa38-Xaa39-Xaa40-COR1
(see, e.g., US’383 at SEQ ID NO: 29, ¶¶[0016]-[0044]); wherein Xaa2 is Aib or D-Ser, wherein Xaa10 is Lys; wherein Xaa13 is Tyr; wherein Xaa16 is Aib or Glu; wherein Xaa17 is Lys or Arg; wherein Xaa18 is Ala; wherein Xaa20 is Gln; wherein Xaa21 is Asp or Glu; wherein Xaa23 is Val; wherein Xaa24 is Glu or Gln; wherein Xaa27 is absent; wherein Xaa28 is Arg; wherein Xaa29 is Ala; wherein Xaa30 is Gly; wherein Xaa31 is Gly; wherein Xaa32 is Pro; wherein Xaa33 is Ser; wherein Xaa34 is Ser; wherein Xaa35 is Gly; wherein Xaa36 is Ala; wherein Xaa37 is Pro; wherein Xaa38 is Pro; wherein Xaa39 is Pro; and wherein Xaa40 is Ser (see, e.g., US’383 at SEQ ID NO: 29, ¶¶[0016]-[0044], claim 1, 4, 7), wherein the Lys at Xaa10 is conjugated to a lipophilic substituent via a bridging group of (PEG)m, (or Asp-(PEG)m)wherein m is 2-10, and wherein the lipophilic substituent is CH3(CH2)nCO- or HOOC(CH2)nCO-, wherein n is 10-24 (see, e.g., US’383 at SEQ ID NO: 29, ¶¶[0016]-[0044]). Accordingly, US’383 teaches and directs artisans to the subgenus of 39-mer oxyntomodulin analogue species having the form of
H[Aib,DS]QGTFTSDKSKYLD[Aib,E][K,R]AAQ[D,E]FV[E,Q]WLRAGGPSSGAPPPS
Wherein the underlined Lysine at position 10 is conjugated to CH3(CH2)10-24CO- or HOOC(CH2)10-24CO-, via a bridging group of either (PEG)2-10 or Asp-(PEG)2-10 (see, e.g., US’383 at SEQ ID NO: 29, ¶¶[0016]-[0044]), wherein the linkage includes a formation of an amide bond by an amino group of the Lys at position 10 with a carboxyl group of a (PEG)m terminal modification at one end of the bridging group, and the lipophilic substituent is attached to the amino group of the bridging group at the other end by forming an amide bond with its carboxyl group (see, e.g., US’383 at SEQ ID NO: 29, ¶¶[0016]-[0044], ¶[0044] reproduced in part below):
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It is understood that the “Glu” referenced in the linker is γGlu (compare US’383 at ¶[0044] with US’383 at ¶¶[0088]). Regarding the C-terminal moiety, US’383 teaches that the C-terminal is COR1, wherein R1 may be NH2 (see, e.g., US’383 at ¶¶[0016]-[0044]). Therefore, 39-mer oxyntomodulin analogue species having such C-terminal variability were already known in the prior art. Regarding substitutions of Lys10, US’383 explicitly teaches that the Lys conjugated to the lipophilic moiety may be replaced by HomoLys, Orn, Dap, or Dab (see, e.g., US’383 at ¶[0089], claims 1 and 4). Accordingly, 39-mer oxyntomodulin analogue species having such residues at position 10 were already known and disclosed in the prior art. Regarding instant claims 12, 13, and predicted and expected utility of the 39-mer oxyntomodulin analogues, US’383 teaches and discloses that such compounds are oxyntomodulin analogues, which may be usable in therapeutic applications of treating diabetes and other diseases (see, e.g., US’383 at abs, ¶¶[0001]-[0011], [0076]-[0081], claims 1, 8-11). Such compounds include tested 39-mers (see, e.g., US’383 at SEQ ID NOs: 3-4, 19-24, Table 1 at ¶[0136], Table 2 at ¶[0139], showing all tested compounds, including all 39-mers, performed better than Exenatide, Glucagon, or Oxyntomodulin with respect to EC50 for either GLP-1R or GCGR or both). In sum, the prior art of US’383 teaches and discloses multiple species that differ from the instantly claimed subgenus of compounds only with respect to a single position, which US’383 teaches may be arginine, but wherein the instant claims require it to be lysine (see, e.g., instant claim 1 at position 27).
The primary reference differs from the instant claim scope as follows: The primary reference teaches and directs artisans to a subgenus of almost identical 39-mer oxyntomodulin analogues, taught for the same purpose and utility (i.e., treatment of diabetes), that differ from the instant claim scope only with respect to the 27th position from the N-terminal of the analogues at issue. US’383 teaches that the position may be arginine, but the instant claims require lysine. Therefore, the relevant issue is whether or not it would be obvious to simply substitute the cationic amino acid of arginine with the cationic amino acid of lysine, with a reasonable expectation of success.
Background: as an initial matter, US’383 and WO’439 pertain to related compounds, namely analogues of Glucagon, Glucagon-like peptides, and GLP-1R/GCGR dual agonists (see, e.g., US’383 at SEQ ID NO: 29, ¶¶[0011]-[0044]; see also WO’439 at 1 at lines 11-21). These documents establish that the relevant knowledge and predictability of modifications at various positions of GLP-1R/GCGR dual agonists, such as oxyntomodulin, was extensive in the prior art. In view of these references, an artisan would readily appreciate that GLP-1R/GCGR dual agonists were well-known in the prior art, and that such compounds were commonly based upon the variations, combinations, consensus structures, and substitutions of the sequences (or combined sequences) of GLP-1, GLP-2, OXM (oxyntomodulin), Glucagon, and Exendin-4 (see, e.g., US’383 at SEQ ID NO: 29, ¶¶[0011]-[0044], [0077], claims; see also WO’439 at 1 at lines 11-21, 5 at lines 7-11, claims; see US’383 at ¶¶[0011]-[0042],, noting that positions Xaa30 to Xaa40 of the oxyntomodulin analogues correspond to the final eleven amino acids of Exenatide rather than OXM). WO’439 provides a wealth of collected knowledge and general information known to artisans in the GLP-1R/GCGR dual agonist arts, which permit artisans to reasonably predict the general impacts of particular modifications. This is pertinent because WO’439 pertains to GLP-1R/GCGR dual agonists (see, e.g., WO’439 at 1 at lines 11-21), including oxyntomodulin analogues (see id.; see also WO’439 at 101 at lines 5-11, 103 at lines 7-25, 107 at lines 25-30), and because Oxyntomodulin at positions 1-29 correspond to glucagon (see, e.g., WO’439 at 103 at lines 18-20; see also US’383 at SEQ ID NO: 29, ¶¶[0011]-[0044]), the guidance of WO’439 is relevant to Oxyntomodulin analogues.
Regarding the obviousness of substituting one amino acid residue for a conservative substitution: This is pertinent because MPEP § 2144.08(II)(A)(4)(c) states that some differences may be “of little importance”, and identifies that “[i]n the area of biotechnology, an exemplified species may differ from a claimed species by a conservative substitution (‘the replacement in a protein of one amino acid by another, chemically similar, amino acid... [which] is generally expected to lead to either no change or only a small change in the properties of the protein.’ Dictionary of Biochemistry and Molecular Biology 97 (John Wiley & Sons, 2d ed. 1989))”). Accordingly, conservative substitutions would be predicted to “lead to either no change or only a small change” absent objective evidence to the contrary.
Arginine and Lysine are art-recognized conservative substitutions: WO’439 identifies that histidine, arginine, lysine, and ornithine (Orn) are cationic residues that are considered “conservative amino acid substitutions” (see, e.g., WO’439 at 27 at lines 1-10). Therefore, arginine and lysine are art-recognized conservative substitutions.
Prior art discloses that substituting any cationic amino acid at positions 27-29 would be reasonably predicted and expected to improve solubility: WO’439 provides generally guidance regarding the placement of charged amino acids within the C-terminal portion of native glucagon (i.e., positions 27-29) (see, e.g., WO’439 at 7-8 at bridging ¶), and specifically notes that such residues are permissible, and would be expected to improve solubility (see id). WO’439 does not specifically restrict what cationic amino acid must be utilized (see id.) and therefore an artisan would reasonably appreciate that any cationic amino acid could be utilized to improve solubility at these positions (see id.)
Prior art discloses that substituting cationic amino acids or conservative substitutions at positions 27-29 would not be reasonably expected or predicted to abrogate activity: WO’439 identifies conservative substitutions at one or more of positions 27, 28, or 29, and/or substitution of one or more of these positions with Alanine “do not substantially affect activity” (see, e.g., WO’439 at 9 at lines 4-10).
Therefore, an artisan would readily appreciate that the simple, conservative substitution of lysine in place of arginine at positions 27-29 would desirably improve solubility, would not abrogate activity, or both.
In summary, US’383 teaches and directs artisans to a subgenus of 39-mer oxyntomodulin analogues having the form of
H[Aib,DS]QGTFTSDKSKYLD[Aib,E][K,R]AAQ[D,E]FV[E,Q]WLRAGGPSSGAPPPS
Wherein the underlined Lysine at position 10 is conjugated to CH3(CH2)10-24CO- or HOOC(CH2)10-24CO-, via a bridging group of either (PEG)2-10 or Asp-(PEG)2-10 (see, e.g., US’383 at SEQ ID NO: 29, ¶¶[0011]-[0044], see esp. id. at ¶¶[0042]-[0044]), and wherein such compounds have known and predicted utility (see, e.g., US’383 at abs, ¶¶[0001]-[0011], [0076]-[0081]). The singular difference between the US’383 subgenus of 39-mer oxyntomodulin analogues and instant claims 1-4, 6, 10, and 12-13, is that US’383 teaches the cationic amino acid of arginine at the 27th position from the N-terminal, rather than Lysine, as instantly claimed. However, in view of MPEP § 2144.08(II)(A)(4)(c) and WO’439, an artisan would (i) readily appreciate and predict that any cationic residue could be utilized to predictably improve solubility without abrogating activity, (ii) that arginine and lysine are conservative substitutions, (iii) that conservative substitutions would be predicted to “lead to either no change or only a small change” absent objective evidence to the contrary (MPEP § 2144.08(II)(A)(4)(c)), and (iv) that conservatively substituted 39-mer oxyntomodulin analogues having lysine rather than arginine at the 27th position from the N-terminal would be predicted and expected to have the same utility (i.e., therapeutic treatments known and associated with oxyntomodulin analogues).
Therefore, it would have been obvious to one of ordinary skill in the art, either before the effective filing date of the claimed invention (AIA ) or otherwise at the time the invention was made (pre-AIA ), to arrive at the instantly claimed invention in view of the prior art for at least the following reason(s): The claimed invention is the obvious, simple substitution of one cationic amino acid (i.e., lysine) in place of another cationic amino acid (i.e., arginine) within a prior art subgenus of functionally equivalent 39-mer oxyntomodulin analogues, wherein such simple substitution of conservative amino acid substitution would yield nothing more than predictable results, namely 39-mer oxyntomodulin analogues that would predictably and expectedly act as GLP-1R/GCGR dual agonists and be useable in all therapeutic applications that US’383 discloses for oxyntomodulin analogues (see, e.g., MPEP § 2143(I)(B), (F); MPEP § 2144.08(II)(A)(4)(c)4; MPEP § 2144.09(I)5; MPEP § 2144.06(II)6; see also KSR Int'l v. Teleflex Inc., 550 U.S. 398, 415 (2007), at 416, explaining that [t]he combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results”; see also KSR Int'l v. Teleflex Inc., 550 U.S. 398, 415 (2007), at 417, explaining that “If a person of ordinary skill can implement a predictable variation, § 103 likely bars its patentability”).
No evidence of any unexpected results commensurate in scope with the requirements of MPEP §§ 716, 716.01, or 716.02 have been placed on record to date, showing that any species within the obvious subgenus of 39-mer oxyntomodulin analogues having the form of
H[Aib,DS]QGTFTSDKSKYLD[Aib,E][K,R]AAQ[D,E]FV[E,Q]WL[RK]AGGPSSGAPPPS
wherein the underlined Lysine at position 10 is conjugated to CH3(CH2)10-24CO- or HOOC(CH2)10-24CO-, via a bridging group of either (PEG)2-10 or Asp-(PEG)2-10, exhibit unexpected results relative to the closest existing prior art.
Furthermore, there would be a reasonable expectation of success because the prior art is presumed fully enabled (see, e.g., MPEP § 2121(I)) for all that it discloses (see, e.g., MPEP §§ 2123(I)-(II)), including nonpreferred and alternative embodiments (see, e.g., MPEP §§ 2123(II)). Furthermore, it is well-within the ordinary skill in the art to make and use 39-mer oxyntomodulin analogues having a conservative substitution, or otherwise make functionally equivalent variants of known 39-mer oxyntomodulin analogues by substituting one conservative, cationic amino acid for another at a known position, wherein such substitutions had known and predictable impacts on 39-mer oxyntomodulin analogue solubility and activity.
Claims 1-3,10, and 12-13 are rejected.
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.
[Provisional NSDP Rejection 01]
Claims 1-3, 7, and 9-13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of copending Application No. 18/272,992 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other as explained below.
Claim interpretation: For purposes of consideration under NSDP analysis, below, claim 10 is understood to properly fall within the scope of claim 1 and reflect structures of claim 11.
Amended claims 1-3, 7, and 9-13 appear to substantially mirror the language and structures recited at claims 1-14 of App’992 (compare instant claims 1-4, 6-7, and 9-13 with App’992 at claims 1-14 as filed 7/18/2023). For example, the originally elected species reading upon instant claims 1-4, 6-7, and 9-13 appears to be explicitly recited at claim 11 of the copending application (compare structures enumerated at App’992 at claim 11 with structures at instant claims 1 and 11). Furthermore, the copending claims directly encompass products as instantly claimed (see, e.g., App’992 at claim 13-14). In addition, or alternatively, although claims 1-12 of App’992 are directed ostensibly to methods, the claims expressly recited the instantly claimed products, and therefore the usage of such products anticipates the existence of the product.
Accordingly, under an anticipation rationale, it is clear that the copending claims are directed to substantially and materially overlapping subject matter. Accordingly, amended claims 1-3, 7, and 9-13 are rejected.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant’s arguments with respect to pending claims have been fully considered but are substantially rendered moot in view of the new and revised rejections of record as necessitated by Applicant’s amendments filed 12/23/2025. Remaining applicable arguments are addressed below.
It is the Examiner’s understanding that Applicant traverses the prior rejection under 35 USC 103 over US’383 (see, e.g., Reply filed 12/23/2025 at 18 at § Rejections). The arguments have been fully considered but not found persuasive in view of the revised rejection set forth above, which was necessitated by Applicant amendments. The revised rejections directly addresses previously unexamined, non-elected species of 39-mer OXM analogues within the scope of amended claim 1, having a Lysine at the 27th position from the N-terminal, while simultaneously having an alanine at the 28th position from the N-terminal. Accordingly, such arguments have been fully considered, but not found persuasive in view of the revised rejection and combined teachings of US’383 in view of WO’429.
It is the Examiner’s understanding that Applicant traverses the provisional NSDP rejection over copending Application 18/272,992 at page 16 (see, e.g., Reply filed 12/23/2025 at 15 at § Provisional NSDP Rejection 01). Applicant admits that “the polypeptide compound of U.S. Application No. 18/272,992 are the same as those of the present application” (see id), but alleges that the copending application is directed to “a second pharmaceutical use patent of this application” (see id). This is not persuasive. First, a proper response to a rejection for nonstatutory double patenting is filing of a TD, amendment to distinguish from the reference patent, or persuasive arguments as to why the rejection is incorrect. See MPEP §§ 804(I)(B)(1) and 804.02(II)(A). Second, a NSDP rejection is not precluded by 35 USC § 121, and App’992 is not a DIV of the instant Application. Third, as explained in the rejection, the copending claim set is directed to the instant claim scope under an anticipation analysis, and contrary to Applicant’s statements, the copending application recites composition claims. In sum, all arguments have been fully considered, but not found persuasive. Accordingly, the rejection in view of App’992 is maintained as revised above, and all revisions were necessitated by Applicant’s amendments.
Accordingly, all applicable arguments have been fully considered but not found persuasive as explained above. Accordingly, the claims are rejected.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 11419918 B27 discloses highly similar compounds at instant claim 1, but claim 1 recites a wherein clause limiting the “(PEG)m” moiety to (PEG2)2 (see US’918 at claim 1).
US 8507428 B28 pertains to glucagon analogs (see US’428 at title, abs, claims), including embodiments with PEG linkers and hydrophilic spacers (see, e.g., US’428 at col 29 at lines 15-60).
US20180094038A19 (Apr. 5, 2018) pertains to acylated glucagon analogues (see, e.g., US’038 at title, abs, claims), including embodiments using a GSGSGG linker (see, e.g., US’038 at claims). US’038 explains the relationship between glucagon and oxyntomodulin analogues (see, e.g., US’038 at ¶[0033]), which overlap substantially in scope because oxyntomodulin (37-amino acids in length) fully comprises glucagon, which is 29 amino acids in length (see id).
WO2013/192129A110 (Dec. 27, 2013) teaches and discloses glucagon analogs for use in treating diabetes and obesity, wherein such compounds comprise
HX2 X3GTFTSDX10SKYLX15X16X17X18X19X20X21FVQWLX27X28X29X30PSSGX35PPPS
(see, e.g., WO’129 at ¶[0012]). This genus includes embodiments wherein X2 is Aib; X3 is Gln (Q); X10 is “an amino acid covalently attached to a C12 to C18 acyl or alkyl group”; X15 is Glu (E) or Asp (D); X16 is Glu (E) or “any amino acid”; X17 is Arg; X18 is Ala; X19 is Ala; X20 is Gln; X21 is Asp or Glu; X27 is Leu; X28 is Asp, Ala, or Glu; X29 is Gly; X30 is Gly; and X35 is Ala (see, e.g., WO’129 at ¶[0012], claim 1, 20-24, 80-85). Regarding modifications at the lysine at position 10, WO’129 explicitly teaches and directs artisans to modify such glucagon analogues at a lysine at position 10 (“Formula I”), wherein the amino acid is conjugated to a C12 to C18 acyl or alkyl moiety via “a spacer” (see, e.g., WO’129 at ¶[0012], claim 1, 20-24, 80-85), wherein the acyl moiety may comprise a structure of CH3(CH2)1-29C(O)- (see, e.g., WO’129 at ¶[00487]), and be conjugated to a lysine via a γGlu-γGlu dipeptide linker (see, e.g., WO’129 at ¶[00487]). Regarding (PEG)m spacers, WO’129 identifies that the “spacer” between the lysine side chain and the acyl moiety may comprise PEG moieties, including amido miniPEGs having the structure of -N-CH2-CH2-[-O-CH2-CH2-]2-COO- (see, e.g., WO’129 at ¶¶[0085], [0089]-[0090]).
US2011/0098215A1 11 (Apr. 28, 2011) explains that (a) isovaline and valine and (b) glutamic acid and aspartic acid, were art-recognized conservative substitutions (see, e.g., US’215 at ¶[0164], noting that “valine and isovaline” and “substitutions between amino acids with an acidic side chain (e.g., E or D)” are “[c]onservative substitutions”, that are “well known in the art”). Accordingly, an artisan would reasonably predict and expect that such “conservative substitutions” would “lead to either no change or only a small change in the properties of the protein” (see, e.g., MPEP § 2144.08; see also MPEP § 2144.09).
US 10,479,819 B212 (Nov. 19, 2019) claims highly similar compounds as those instantly claimed because US’819 is directed to compounds comprising an oxyntomodulin analogue (positions 1-29) conjugated to an C-terminal extension moiety having the general structure of
His-Xaa2-Gln-Gly-Thr-Phe-Thr-Ser-Asp-Xaa10-Ser-Lys-Xaa13-Leu-Asp-Xaa16-Xaa17-Xaa18-Ala-Xaa20-Xaa21-Phe-Xaa23-Xaa24-Trp-Leu-Xaa27-Xaa28-Xaa29-[C-terminal Extension]-COR1
(see, e.g., US’819 at claims 1, 5). US’819 is the issued patent corresponding to US’383 as applied under 35 USC 103, above, and therefore the discussion above applies to US’819.
WO2013/19212913 (Dec. 27, 2013) pertains to Glucagon analogues (compare instant claim 1 with WO’129 at claim 1), and is therefore analogous art. WO’129 explains that the C-terminal extensions is placed after position 29 of the glucagon analogue, and exemplifies that analogs may be conjugated to a C-terminal extensions that forms “a Trp cage”, including GPSSGAPPPS (SEQ ID NO: 5), GGPSSGAPPPS (SEQ ID NO: 6), GPSSGRPPPS (SEQ ID NO: 68), or a sequence differing from SEQ ID NOs: 5, 6, and 68 by 1-3 conservative substitutions (see, e.g., WO’129 at ¶¶[00314], [00350]-[00352], claim 1). Accordingly, the prior art teaches that GPSSGAPPPS and GGPSSGAPPPS were prior art “C-terminal extensions”, taught explicitly for use with glucagon analogues and placed C-terminal to position 29 of a glucagon analogue, wherein such sequences were functional equivalents that form “a Trp cage” (see id). In addition, WO’129 explicitly identifies that position 18 was known in the art to be either “Arg or Ala” (see, e.g., WO’129 at claims 1, 30, ¶[00247], SEQ ID NO: 1, noting that dibasic “Arg-Arg” appears at positions 17 and 19). Accordingly, one of ordinary skill in the Glucagon analogue arts would have readily appreciated that glucagon analogues could have Arg or Ala present at position 18, with a reasonable expectation that such compounds would predictably act as Glucagon analogues.
US 11,197,914 B214 (Dec. 14, 2021) teaches and discloses a genus of method utilizing products that would be at once envisaged in view of the method steps, including glucagon analogues having the structure of
His-Xaa2-Gln-Gly-Thr-Phe-Thr-Ser-Asp-Xaa10-Ser-Lys-Xaa13-Leu-Asp-Xaa16-Xaa17-Xaa18-Ala-Xaa20-Xaa21-Phe-Xaa23-Xaa24-Trp-Leu-Xaa27-Xaa28-Xaa29-Xaa30-Xaa31-Xaa32-Xaa33-Xaa34-Xaa35-Xaa36-Xaa37-Xaa38-Xaa39-Xaa40-COR1
wherein Xaa2 is Aib or D-Ser, wherein Xaa10 is Lys; wherein Xaa13 is Tyr; wherein Xaa16 is Aib or Glu; wherein Xaa17 is Arg; wherein Xaa18 is Arg; wherein Xaa20 is Gln; wherein Xaa21 is Asp; wherein Xaa23 is Val; wherein Xaa24 is Gln; wherein Xaa27 is Leu; wherein Xaa28 is Asp; wherein Xaa29 is absent; wherein Xaa30 is Gly; wherein Xaa31 is Gly; wherein Xaa32 is Pro; wherein Xaa33 is Ser; wherein Xaa34 is Ser; wherein Xaa35 is Gly; wherein Xaa36 is Ala; wherein Xaa37 is Pro; wherein Xaa38 is Pro; wherein Xaa39 is Pro; and wherein Xaa40 is Ser; furthermore wherein Lys at position 12 is conjugated to a lipophilic moiety via a linker having the structure or -(PEG)2-10-γGlu-CO(CH2)10-24CO2H or else -(PEG)2-10-γGlu-CO(CH2)10-24CH3 (see, e.g., US’914 at claims 1).
US9,340,600 discloses SEQ ID NOs: 151, 341, and 384 (see, e.g., US’600 at col 49 at lines 5-25), which each comprises lysine at position 27, but each sequence also lacks an alanine at position 28.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new/revised ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/RANDALL L BEANE/ Primary Examiner, Art Unit 1654
1 SEQ ID NO: 13 is disclosed as HXQGTFTSDKSKYLEXKAAQDFVEWLKAGGPSSGAPPPS, wherein the X at position (2) is is D-Ser and the second “X” at position (16) is Aib, wherein the “Lys” at position (10) is actually a modified Lys, corresponding to a residue wherein a Lys side chain is conjugated to the sequence “-Gly-Gly-Ser-Gly-Ser-Gly-AGlu-CO(CH2)18-COOH”, which may also be written as GGSGSG-γGlu-CO(CH2)18-COOH.
2 SEQ ID NO: 7 is HXQGTFTSDKSKYLDERAAQDFXQWLLEGGPSSGAPPPS, wherein position (2) is D-Ser, (10) is Lys wherein the side chain of Lys is linked to -PEG2-PEG2-AGlu-CO(CH2)18CO2H; (23) is Isovaline (i.e., Iva).
3 Cited in previous action.
4 MPEP § 2144.08(II)(A)(4)(c) states that some differences may be “of little importance”, and identifies that “[i]n the area of biotechnology, an exemplified species may differ from a claimed species by a conservative substitution (‘the replacement in a protein of one amino acid by another, chemically similar, amino acid... [which] is generally expected to lead to either no change or only a small change in the properties of the protein.’ Dictionary of Biochemistry and Molecular Biology 97 (John Wiley & Sons, 2d ed. 1989))”).
5 See, e.g., MPEP § 2144.09(I), explaining that A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979)).
6 For MPEP § 2144.06(II), note that in view of MPEP 2144.08(II)(A)(4)(c), conservative substitutions are reasonably viewed as art-recognized equivalents absent objective evidence to the contrary. No objective evidence to the contrary has been placed on record at this time.
7 Cited in previous action.
8 Cited in previous action.
9 Cited in previous action.
10 Cited in previous action.
11 Cited in previous action.
12 Cited in previous action.
13 Cited in previous action.
14 Cited in previous action.