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 .
Claim Status
Claims 13-18, 26-30, 33, 42-44, 46, 54, 64-69 are pending. Claims 1-12, 19-25, 35-40, and 45-46 were canceled; claims 64-69 were newly added; and claims 13-16, 18, 26-27, 29-30, and 46, were amended in the Reply filed 12/15/2025. Claims 27-29, 33, 42-44, 46, 54, and 69 are withdrawn. Claims 13-18, 26, 30, and 64-68 are presently considered.
Election/Restrictions
Applicant’s election of Group I (products, original claims 1-30, 33, 35-40, 42-46) and the species of A14E, B16H, B25H, B29K(N(ε)-docosanedioyl-γGlu-6xOEG), desB30 human insulin (Compound 14, Example 16 of the Specification) in the reply filed on 7/08/2025 was previously acknowledged, and the response was treated as an election without traverse (MPEP § 818.01(a)).
The originally elected species was understood to be
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Applicant did not identify which portions arbitrarily constitute a linker or arbitrarily constitute the albumin-binding moiety. The originally elected species was previously understood to read upon claims 1-11, 13-18, 25, 26, and 30, as filed 1/17/2025. The originally elected species is understood to continue reading upon one or more claims filed 12/15/2025. Specifically, the originally elected species is understood to continue reading upon instant claims 13-18, 26, 30, and 64-68. However, claims 54 and 69 are directed to non-elected Group II, and claims 27-29, 33, 42-44, and 46 are understood to be withdrawn as indicated by the Applicant (see, e.g., Reply filed 12/15/2025 at 11 at 1st to 5th ¶¶) and for reasons of record discussed in the prior action.
Following extensive search and examination, the originally elected species has been deemed obvious for reasons of record in the prior action (see, e.g., Action mailed 9/16/2025 at pages 8-17). In the Reply filed 12/15/2025, Applicant identified evidence of unexpected results commensurate in scope with the requirements of MPEP §§ 716, 716.01, and 716.02 pertaining to two claimed species, namely
A14E, B16H, B25H, B29K(N(ε)-docosanedioyl-γGlu-6xOEG), desB30 human insulin
A14E, B16H, B25H, B29K(N(ε)-eicosanedioyl-γGlu-6xOEG), desB30 human insulin
Accordingly, these species have been identified as allowable over the prior art. Examination has proceeded to a non-elected species per MPEP § 803.02(III)(A), namely the species of
A14E, B16H, B25H, B29K(N(ε)-eicosanedioyl-γGlu-5xOEG), desB30 human insulin
This species was previously addressed on record, and following extensive search and examination, this species has again been deemed obvious in view of the prior art of record.
Claims 27-29, 33, 42-44, 46 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 7/08/2025.
Claims 54 and 69 are 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. Election was made without traverse in the reply filed on 7/08/2025.
Claims 13-18, 26, 30, and 64-68 are presently considered.
Priority
The priority claim to CN201911398378.0 (filed 12/30/2019) and CN202011057926.6 (filed 9/29/2020) are each acknowledged.
Examiner notes that no certified translation of the Foreign Application CN201911398378.0 (filed 12/30/2019) and CN202011057926.6 (filed 9/29/2020) has been placed on record. If applicant wants the application to be accorded benefit of the non-English language application, a certified translation is required (see 35 U.S.C. 119(b)(3), 37 CFR 1.55(g)(1)-(4)). Applicant is advised that any showing of priority that relies on a non-English language application is prima facie insufficient if no certified translation of the application is on file. See 37 CFR 41.154(b).
Information Disclosure Statement
The IDS filed 12/15/2025 is acknowledged and presently considered.
Claim Interpretation
The applicable claim interpretation has been set forth previously on record, and that discussion is incorporated into the instant Action. Claim 13 as filed 12/15/2025 is representative of the pending claim scope.
Additional claim interpretations are set forth below.
Withdrawn Claim Rejections
The rejections of claims 3-9 and 13-17 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite, is withdrawn in view of the cancellation of claims 3-9 and the amendments to claims 13-16 as filed 12/15/2026.
The rejection of claims 1-3, 10-11, and 26 under 35 U.S.C. 102(a)(1)/(a)(2) as being clearly anticipated by US 2011/0105720 A1 is withdrawn in view of the cancellation of claims 1-3, 10-11, and the amendments to claim 26 as filed 12/15/2026.
The rejection of claims 1-11, 13-18, 25-26, and 30 under 35 U.S.C. 103 as being unpatentable over US 2011/0105720 A1 as applied to claims 1-3, 10-11, and 26 above, is withdrawn in view of the cancellation of claims 1-11 and 25, and in view of the amendments to claims 13-16, 26, and 30 as filed 12/15/2026. Applicant successfully traversed-in-part the rejection with respect to the species of
A14E, B16H, B25H, B29K(N(ε)-docosanedioyl-γGlu-6xOEG), desB30 human insulin
A14E, B16H, B25H, B29K(N(ε)-eicosanedioyl-γGlu-6xOEG), desB30 human insulin
A revised rejection addressing remaining issues, as necessitated by Applicant amendment, has been placed on record below.
Revised 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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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 13-18, 26, and 64-65 are rejected under 35 U.S.C. 103 as being unpatentable over US 2011/0105720 A1 (cited in previous action).
Claim interpretation: The applicable claim interpretation has been set forth in a preceding section above, and those interpretations are incorporated into the instant rejection. Additional claim interpretations are set forth below. The originally elected species of A14E, B16H, B25H, B29K(N(ε)-docosanedioyl-γGlu-6xOEG), desB30 human insulin is understood to fully satisfy the structural limitations of instant claims 113-18, 26, 30, and 64-68.
Regarding instant claims 13-18, 26, 64-65, and the structural limitations of the originally elected species, US’720 teaches, discloses, and claims similar structures, including the following species:
A14E, B16H, B25H, B29K(N(ε)-eicosanedioyl-γGlu-2xOEG), desB30 human insulin
(see, e.g., US’720 at claim 8, 15, ¶¶[0374]-[0375], [0377], [0384], [0394]-[0395]. [0401], [0586], [0604]). Such embodiments correspond to Formula (C) at claim 1 wherein the insulin parent is A14E, B16H, B25H, desB30 human insulin; Y1 is a fatty diacid having 18 or 20 carbons1; Y2 is γGlu; m1 is 1; Y3 is OEG2; n1 is 2; and the components are linked by amide bonds, wherein the moiety corresponding to Formula (C) is linked to the ε amino group of the lysine of the insulin parent (compare id. with instant claim 1, 64-65, and originally elected species). Regarding instant claim 26 and pharmaceutical compositions, and predicted and expected utility, US’720 reasonably informs artisans that the disclosed and obvious embodiments claimed may be utilized in pharmaceutical formulations suitable for use in methods of treating subjects with type 1 and type 2 diabetes (see, e.g., US’720 at claims 1, 6, 8, 13-16).
The disclosed species of the prior art differs from the instant claims as follows: The exemplified embodiment of US’720 comprising an eicosanedioyl moiety differs from the pending claims 13-18, 26, 30, 64-68 because it has an n1 of 2 rather than 5-9 (i.e., 2xOEG rather than 5xOEG to 9xOEG).
Regarding n1 and the number of OEG repeats, simply repeating the known OEG five to nine times is obvious in view of US’720: The issue is whether or not it would have been obvious to modify the prior art species of
A14E, B16H, B25H, B29K(N(ε)-eicosanedioyl-γGlu-2xOEG), desB30 human insulin3
by extending the OEG moiety, such that OEG is repeated 5-9 times, rather than only twice as exemplified. However, such a difference is obvious for several rationales. First, US’720 explicitly teaches general formulas including
Acy-AA10-3-AA20-10-AA30-10-(I)
(see, e.g., US’720 at claims 6 and 8, ¶¶[0056]-[0058], [0138], [0167], [0375]-[0394], [0401], [0489], [0583], [0604]), and explicitly teaches that the corresponding position of AA3 may be repeated 1-10 times (see id.). Accordingly, such difference in repeating OEG from once to ten times is within the range explicitly taught and claimed by the prior art (see, e.g., id.; see also MPEP § 2144.05(I), noting that where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists). Second, OEG is a known chemical structure, and the only difference is the number of times the known structure is repeated. Per MPEP § 2144.09(I)-(II), a prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities, wherein compounds that are homologs (i.e., compounds differing by the successive addition of the same chemical group, are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. Here, the compounds are acylated insulins in both the instant claims and US’720, and the only difference appears to be the successive addition of the same chemical group, namely OEG. Accordingly, such homologs would be presumed to have the same or highly similar properties absent objective evidence to the contrary commensurate in scope with MPEP §§ 716, 716.01, and 716.02. Third, US’720 exemplifies Acy-AA10-AA21-AA31, 3,4, 10 moieties at columns 27 and 28 at ¶[0167], including
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which is eicosanedioyl-γGlu-10xOEG moiety (see, e.g., US’720 at ¶[0167] at col. 28 at third full structure on page). US’720 also exemplifies an eicosanedioyl-γGlu-1xOEG moiety, an eicosanedioyl-γGlu-3xOEG moiety, and an eicosanedioyl-γGlu-4xOEG moiety (see id. at ¶[0167] at cols. 27-28). In view of the teachings that AA3 may be repeated 1-10 times, and the exemplification of 1xOEG, 2xOEG, 3xOEG, 4xOEG, and 10xOEG (see, e.g., US’720 at claims 6, 8, ¶[0167] at col. 27-28), an artisan would readily appreciate that OEG could be repeated in the exemplified structures between 1 and 10 times or otherwise that different lengths of OEG repeats could be simply substituted for other lengths (see, e.g., id.; see also MPEP §§ 2144.05(I), 2144.09(I)-(II), 2144.07, 2143(I)(A),(B)). Accordingly, variation in OEG length is well-within the scope of the prior art, which would reasonably direct artisans to embodiments such as
A14E, B16H, B25H, B29K(N(ε)-eicosanedioyl-γGlu-1-10xOEG), desB30 human insulin4.
Ins sum, the prior art exemplifies embodiments that only differ from the instantly claimed species with respect to the number of time the OEG linker is repeated, but US’720 explicitly teaches that this difference was fully contemplated and permissible.
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 combination (or substitution) of known prior art components (i.e., known acyl moieties, known human insulin analogues, known linkers (i.e., OEG, γGlu), known linkages via B29K, etc.) according to known methods taught and disclosed by US’720 for constructing acylated insulin analogues exactly as taught and claimed by US’720, wherein such combinations yield only predictable and expected results, such as
A14E, B16H, B25H, B29K(N(ε)- eicosanedioyl -γGlu-1-10xOEG), desB30 human insulin
wherein such compounds would be predicted and expected to have the utilities and benefits disclosed by US’720, including applications in the treatment of Type 1 and 2 diabetes (see, e.g., MPEP §§ 2143(I)(A), (B), (G)). Furthermore, each prior art element merely performs its art-recognized function in combination as it does separately.
To date, zero evidence commensurate in scope with the requirements of MPEP §§ 716, 716.01, and 716.02 have been placed on record.
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)). Furthermore, it is well-within the ordinary skill in the art to combine known components in known arrangements to obtain a known and expected result having a known and art-recognized utility. In addition or alternatively, it is well-within the ordinary skill in the art to simply substitute known OEG linkers and acyl moieties in exemplified embodiments, with other OEG linkers and acyl moieties explicitly taught by the same reference, to predictably and expectedly obtain variants of the exemplified embodiments expected and predicted to have the same general properties and utilities.
Accordingly, claims 13-18, 26, and 64-65 are rejected.
Response to Arguments
Applicant's arguments filed 12/15/2025 have been fully considered but they are not persuasive. The arguments pertaining to withdrawn rejections are moot. Applicant addresses rejections premised upon the teachings of US’720 at pages 12-14 of the Reply (see, e.g., Reply filed 12/15/2025 at 12 at § “35 U.S.C. § 103” to page 14 at 4th full ¶), and these applicable arguments are addressed below.
It is the Examiner’s understanding that Applicant refers to a rationale under MPEP § 2143(I)(E) (see, e.g., Reply filed 12/15/2025 at 12 at final ¶, 13 at 2nd full ¶, referring to a “finite number of predictable solutions”). This is not persuasive because the Examiner did not rely upon the rationale at MPEP § 2143(I)(E), but instead relied upon the exemplary rationales of MPEP §§ 2143(I)(A), (B), and (G) to support a determination of obviousness. Applicant does not address, acknowledge or specifically identify any elements of MPEP §§ 2143(I)(A), (B), and (G) that were not satisfied and addressed on the merits. Accordingly, the rationales of MPEP §§ 2143(I)(A), (B), and (G) are maintained as set forth above.
It is the Examiner’s understanding that Applicant is alleging that the prior art does not provide a reasonable expectation of success and is “highly unpredictable” (see, e.g., Reply filed 12/15/2025 at 12 at final ¶, alleging that the art is “highly unpredictable” and that US’720 does not provide any solutions with “anticipated success”; see also id. at 14, alleging lack of reasonable expectation of successfully altering the number of OEG repeats). MPEP § 2143.02(I)-(III) discusses the level of predictability and guidance required to establish a “reasonable expectation of success” sufficient to establish obviousness. As explained at MPEP § 2143.02(II), “Obviousness does not require absolute predictability”, but rather only “at least some degree of predictability”. Here, the predicted and expected applications of the US’720 structures is expressly identified (see, e.g., US’720 at claims 1, 6, 8, 13-16, reasonably informing artisans that the disclosed embodiments may be predictably utilized in pharmaceutical formulations suitable for use in methods of treating subjects with type 1 and type 2 diabetes). This is pertinent 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)), and the burden is on the Applicant to rebut operability and enablement (see, e.g., MPEP § 2121(I)) commensurate in scope with the requirements of MPEP §§ 716.05 or 716.07. To date, zero evidence of inoperability (MPEP § 716.07) or skepticism of experts (MPEP § 716.05) has been placed on record. Accordingly, because the prior art is presumed fully enabled and no evidence to the contrary exists, then there is a reasonable expectation that the disclosed embodiments of US’720 can be predictably and successfully utilized exactly as disclosed for the exact purpose taught and disclosed by the prior art.
It is the Examiner’s understanding that Applicant is alleging that the prior art renders additional species and embodiments obvious (see, e.g., Reply filed 12/15/2025 at 13 at 2nd full ¶, alleging that the genus of US’720 is broad). The fact that the prior art anticipates and renders obvious additional species and subgenera, which are not currently at issue, does not render the relevant disclosures concerning the instantly claimed invention non-existent (see, e.g., MPEP §§ 2123(I)-(II), explaining that patents are relevant as prior art for all they contain, including nonpreferred and alternative embodiments). If Applicant is suggesting that the disclosure of US’720 “teaches away” from the claimed invention in view of the disclosure of additional compounds and subgenera, this is not persuasive per MPEP § 2123(II), which explicitly notes that disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments (see, e.g., MPEP §§ 2123(II)). Furthermore, the Court has stated that
"[W]hen a patent 'simply arranges old elements with each performing the same function it had been known to perform' and yields no more than one would expect from such an arrangement, the combination is obvious."
KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 , 417 , 127 S. Ct. 1727 , 167 L. Ed. 2d 705 (2007) (quoting Sakraida v. Ag Pro, Inc., 425 U.S. 273 , 282 , 96 S. Ct. 1532 , 47 L. Ed. 2d 784 (1976)).
Likewise, the Supreme Court has rejected rigid tests for obviousness and has emphasized 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.”
KSR Int'l v. Teleflex Inc., 550 U.S. 398, 415 (2007), at 416.
And has also emphasized that
“If a person of ordinary skill can implement a predictable variation, § 103 likely bars its patentability.”
KSR Int'l v. Teleflex Inc., 550 U.S. 398, 415 (2007), at 417.
Here, as explained in the rejection above, all elements of the invention are prior art elements, and the prior art literally and explicitly teaches how to arrange such prior art elements to form compounds within the instant claim scope, wherein such compounds merely perform the exact applications taught and disclosed by the prior art.
It is the Examiner’s understanding that Applicant is alleging that the prior art is limited to exemplified embodiments (see, e.g., Reply filed 12/15/2025 at 13 at final ¶, alleging that US’720 only discloses species that “contain at most two OEG repeats”). As explained in the rejection, US’720 explicitly identifies that the OEG portion may be repeated 1-10 times, and therefore Applicant’s basis is factually incorrect. Accordingly, it is presumed that Applicant is alleging that prior art is limited to only disclosed and exemplified embodiments (see id); this is incorrect because prior art is presumed fully enabled (see, e.g., MPEP § 2121(I)) for all that it discloses (see, e.g., MPEP §§ 2123(I)-(II)). Furthermore, disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments (see, e.g., MPEP §§ 2123(II)).
It is the Examiner’s understanding that Applicant identifies unexpected results commensurate in scope with two species (see, e.g., Reply filed 12/15/2025 at 13 at final ¶ to 14 at 2nd full ¶, referring to Figures 10a, 10b, 12a, 12b, Examples 21 and 23, and experiments using Control Compound 5). This data has been considered and deemed to satisfy the requirements of MPEP §§ 716, 716.01, and 716.02 sufficient to rebut prima facie obviousness of the two exemplified species of
A14E, B16H, B25H, B29K(N(ε)-docosanedioyl-γGlu-6xOEG), desB30 human insulin
A14E, B16H, B25H, B29K(N(ε)-eicosanedioyl-γGlu-6xOEG), desB30 human insulin
Accordingly, claims 67-68 have been indicated as allowed; claim 69 is eligible for rejoinder; and claims 30 and 66 are objected as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form. However, the proffered data is not commensurate in scope with instant claims 13-18, 26, and 64-65 for the reasons discussed below.
The proffered evidence of unexpected results is insufficient to satisfy the requirements of MPEP §§ 716, 716.01, and 716.02 with respect to instant claims 13-18, 26, and 64-65 (see, e.g., Reply filed 12/15/2025 at 13 at final ¶ to 14 at 2nd full ¶, referring to Figures 10a, 10b, 12a, 12b, Examples 21 and 23, and experiments using Control Compound 5). The requirements for declarations are discussed MPEP §§ 716 and 716.01, and the evidence required to establish unexpected results sufficient to rebut prima facie obviousness is disclosed at MPEP § 716.02. Here, Applicant fails to explain how the proffered data is commensurate in scope with the genera and subgenera recited at instant claims 13-18, 26, and 64-65 as required by MPEP § 716.02(b)(I)-(II), and 716.02(d). Notably, rather than alleging that such data could be extended to other claimed embodiments, the Applicant has instead stated that “the art is highly unpredictable” (see, e.g., Reply filed 12/15/2025 at 12 at final ¶, emphasis in original)5. Accordingly, Applicant’s own statements regarding the unpredictable nature of the prior art weigh against a determination that the limited evidence of unexpected results could be extended to the full scope of the genus and subgenera recited at claims 13-18, 26, and 64-65 commensurate in scope with the requirements of MPEP § 716.02(d). Accordingly, the proffered evidence fails to establish unexpected results commensurate in scope with the requirements of MPEP § 716.02. Upon weighing the data of record per MPEP § 716.02(c)(I)-(II), the proffered data is insufficient to outweigh the evidence of obviousness. Notably, per MPEP § 716.02(c)(II), “Expected beneficial results are evidence of expected results are evidence of obviousness”, and here the claimed embodiments appear to have the exact applications taught and disclosed by the prior art (i.e., treatment of diabetes), which weighs in favor of a determination of obviousness.
Accordingly, all applicable arguments have been fully considered but not found persuasive as explained above. Therefore, the rejection is maintained as revised above, wherein all revisions were necessitated by Applicant’s amendments.
Allowable Subject Matter
Claims 67-68 are allowed. Claim 69 is eligible for rejoinder.
Claims 30 and 66 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The reason for indicating allowable subject matter is as follows: The evidence of unexpected results identified by the Applicant is commensurate in scope with claims 67-69 and the embodiments recited in dependent claims 30 and 66 (see, e.g., Reply filed 12/15/2025 at page 13 at final ¶ to 14 at 2nd full ¶), and therefore the prima facie case of obviousness has been rebutted with respect to the two species recited at claims 30 and 66-69.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US8722620 (May 13, 2014)6 pertains to acylated insulin analogues, wherein the acyl moiety can vary in length from at least 6-32 carbons (see, e.g., US’742 at title, abs, claims).
US2011/0098439A17 (Apr. 28, 2011) pertains to insulins modified with acyl moieties (see, e.g., US’439 at title, abs, claims 1-2, 5-6).
US2014/0228285A18 (Aug. 14, 2014) pertains to double acylated insulin analogues (see, e.g., US’285 at title, abs, claims).
US2015/0210748A19 (Jul. 30, 2015) pertains to acylated insulin analogues (see, e.g., US’748 at title, abs, claims).
US20170008945A110 (Jan. 12, 2017) pertains to insulins modified with acyl moieties (see, e.g., US’945 at title, abs, claims).
US2018/0000742A111 (Jan. 4, 2018; Hovgaard et al.) pertains to acylated insulin analogues (see, e.g., US’742 at title, abs, claims 1, 9-10, 15-16), including insulin analogues conjugated to docosanedioyl moieties (see id. at ¶¶[0375]-[0376], [1235]-[1236]).
US2018/0305431A112 (Oct. 25, 2018) pertains to acylated derivatives of insulin analogues, wherein insulin analogues are conjugated to acyl moieties via γGlu and OEG linkers, including 10xOEG linkers (see, e.g., US’431 at title, abs, claims 1, 24, 27-32, and 34).
WO2017/032798A113 (Fledulius et al., March 2, 2017) pertains to acylated derivatives of insulin analogues, wherein insulin analogues are conjugated to acyl moieties via γGlu and OEG linkers (WO’798 at title, abs, claim 1-34).
US 20230126068 A1 (US Application 17/758,089) is directed to similar, but not overlapping subject matter.
US 20240025957 A1 (Instant Application 17/758,108) is the PG Publication of the instant Application.
US 20240239862 A1 (US Application 17/758,101) recites similar, but not overlapping subject matter, directed to insulin derivatives other than A14E, B16H, B25H desB30 human insulin derivatives as instantly claimed (see, e.g., App. 101 at claims filed 8/22/2025).
US 20250228919 A1 (US Application 19/052,262) is directed to related subject matter, but was abandoned (see App’262 at Notice of Abandonment mailed 12/15/2025).
US 20250032589 A1 (US Application 18/889,097) pertains to related subject matter, but was abandoned (see App’097 at Notice of Abandonment mailed 10/20/2025).
US 20240239859 A1 (US Application 17/758,113) pertains to related inventions, but are limited to derivatives of GLP-1 (see, e.g., App’113 at claims).
US 20250011385 A1 (US Application 18/883,592) is directed to similar embodiments utilizing GLP-1 rather than insulin derivatives (see, e.g., App’592 at claims). The application was abandoned (see, e.g., App’592 at Notice of Abandonment mailed 10/17/2025).
US 20250340610 A1 (US Application 18/730,552) pertains to related subjected matter, but App’552 is indicated as abandoned in DAV.
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Conclusion
Claims 67-68 are allowed. Claims 30 and 66 are objected. Claims 13-18, 26, and 64-65 are rejected.
Applicant's amendment necessitated the new or 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RANDALL L BEANE whose telephone number is (571)270-3457. The examiner can normally be reached Mon.-Fri., 7 AM to 2 PM ET.
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/RANDALL L BEANE/ Primary Examiner, Art Unit 1654
1 For reference, an artisan would know that C18 is Octadecanedioic acid; C19 is Nonadecanedioic acid; C20 is Eicosanedioic acid; C21 is Heneicosanedioic acid; C22 is Docosanedioic acid; C23 is Tricosanedioic acid; and C24 is tetracosanedioic acid.
2 OEG is -HN-(CH2)2-O-(CH2)2-OCH2CO2H- (see, e.g., US’720 at ¶[0057]).
3 See, e.g., US’720 at claim 8, 15, ¶¶[0374]-[0375], [0377], [0384], [0394]-[0395]. [0401], [0586], [0604]).
4 See, e.g., US’720 at claims 6 and 8.
5 See, also, Springs Window Fashions LP v. Novo Indus., L.P., 323 F.3d 989, 995 (Fed.Cir.2003), noting that “The public notice function of a patent and its prosecution history requires that a patentee be held to what he declares during the prosecution of his patent”).
6 Cited in previous action.
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.