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 Scope
Claims 42-46, 48, 50, 53-54, and 57-59 are pending. Claims 47, 49, 51-52, and 55-56 were canceled, and claim 42 was amended in the Reply filed 12/17/2025. Claims 43-46, 48, 50, 53-54, and 57-58 are withdrawn. Claims 42 and 59 are presently considered.
Election/Restrictions
Applicant’s election of the single, disclosed species corresponding to “page 16, Table 4; Treatment arm: ‘DU 1.5 mg’ and ‘Participants with UACR> 300 mg/g’” in the reply filed on 5/21/2025 was previously acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
The originally elected species has been understood to be “page 16, Table 4; Treatment arm: ‘DU 1.5 mg’ and ‘Participants with UACR> 300 mg/g”, which is disclosed in the Specification filed 11/29/2013 at page 16 at lines 9-16. Notably, Applicant has elected the same species elected in the parent Application1 (i.e., Table 4 and 1.5 mg) and the interpretation of the metes and bounds of the same species of Table 4 was extensively documented on record2,3,4,5, and was not disputed over the course of multiple rounds of prosecution6. Accordingly, the originally elected species is understood to be the species that actually corresponds to the identified disclosure, namely “page 16, Table 4; Treatment arm: ‘DU 1.5 mg’ and ‘Participants with UACR> 300 mg/g’” and any additional conflicting information unsupported by the disclosure is understood to be a mistake or otherwise an insufficient attempt to identify an obvious variant of the originally elected species in the absence of supporting evidence or statements7. Examiner notes that Applicant did not dispute the Examiner’s interpretation in the subsequent Reply filed 12/17/2025.
For purposes of the instant action, the originally elected species of “page 16, Table 4; Treatment arm: ‘DU 1.5 mg’ and ‘Participants with UACR> 300 mg/g’” is interpreted consistent with the parent application (see Footnotes 2-6) and corresponding disclosure in the specification. Accordingly, the elected species is understood to be a 26-week treatment of weekly administration of dulaglutide at 1.5 mg to patients having “moderate and severe CKD and T2DM” wherein the patients exhibited macroalbuminuria (“UACR >300”), (see, e.g., Spec. filed 11/29/2023 at 16 at lines 9 to page 17 at line 6). Accordingly, the originally elected species of “page 16, Table 4; Treatment arm: ‘DU 1.5 mg’ and ‘Participants with UACR> 300 mg/g’” is understood to read upon instant claims 42 and 59.
Following extensive search and consideration, the originally elected species was deemed anticipated and/or obvious in view of the prior art of NCT01621178_201602258 in view of Definition_of_CKD9, as applied below. Accordingly, claims directed to non-examined species are withdrawn.
Claims 43-46, 48, 50, 53-54, and 57-58 remain 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 5/21/2025.
Accordingly, claims 42 and 59 are presently examined.
Denial of Priority
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. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, US Provisional 62/513,556 (filed 6/01/2017) fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
The MPEP states that "[w]hile there is no in haec verba requirment, . . . . claim limitations must be supported in the specification through express, implicit, or inherent disclosure." See MPEP § 2163.
Lack of Express Support
Amended claim 42, as filed 12/17/2025, is representative of the pending claim scope. Claim 42 does not literally appears in Pro’556, and therefore the claims lack literal support in the Pro’556.
Specifically, Pro’556 does not literally disclose the phrases “characterized by a percent HbA1c reduction of at least 1%”, “not more than 3.5 mg/min/1.73m2”, or UACR reduction of at least 28%”, which are recited at amended claim 42.
Accordingly, Pro’556 fails to provide literal support for the pending claim scope that is synonymous or equivalent in scope.
Lack of Implicit or Inherent Support
The MPEP states that "[w]hile there is no in haec verba requirment, . . . . claim limitations must be supported in the specification through express, implicit, or inherent disclosure." See MPEP § 2163. In the absence of express support, the relevant issue is whether or not the claimed invention is supported by the priority document through implicit or inherent disclosures.
Upon review, zero inherent or implicit support commensurate in scope with the metes and bounds of the instant claims is found in Pro’556, at least because Pro’556 does not literally, implicitly, or inherently provide support that is synonymous or equivalent in scope with the phrases “characterized by a percent HbA1c reduction of at least 1%”, “not more than 3.5 mg/min/1.73m2”, or UACR reduction of at least 28%”. According the claim language presently claimed is not supported by the provisional document by synonymous or equivalent language, either inherently or implicitly, commensurate in scope with amended claim 42.
Accordingly, Pro’556 fails to provide implicit or inherent support for the pending claim scope that synonymous or equivalent in scope, or otherwise commensurate in scope with the pending claims.
Conclusion
Accordingly, priority to US Provisional 62/513,556 (filed 6/01/2017) is denied for claim 42 and all of the dependents of those claims; these claims have been accorded a priority date of 5/24/2018, which corresponds to the filing date of PCT/US2018/034278.
Information Disclosure Statement
The IDS filed 12/17/2025 is acknowledged and presently considered.
Claim Interpretation
For purposes of examination, the claim scope has been interpreted as set forth below per the guidance set forth at MPEP § 2111. If Applicant disputes any interpretation, Applicant is invited to unambiguously identify any alleged misinterpretations or specialized definitions in the subsequent response to the instant action. The following interpretations are consistent with the parent Application10.
Independent claim 42, as amended in the Reply filed 12/17/2025 is representative of the pending claim scope. The applicable claim interpretation is set forth below.
“Comprising” is an open-ended transitional term (see, e.g., MPEP § 2111.03(I)), wherein additional steps or components are not excluded. However, “‘[c]omprising’ is a term of art used in claim language which means that the named elements are essential” (see, e.g., id.; see also Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501, 42 USPQ2d 1608, 1613 (Fed. Cir. 1997)).
Patient population: The applicable patient population is defined by the preamble and the “wherein” clause at the final lines of instant claim 42, which recite
….a subject having type 2 diabetes mellitus (T2DM) and chronic kidney disease (CKD)…..wherein prior to initiating the administration the subject’s CKD is characterized by an eGFR of 15-29 mL/min/1.73m2 and a UACR greater than 300 mg/g.
The reference to an “eGFR of 15-29 mL/min/1.732” is understood to be a reference to the population of patients having Stage G4 Chronic Kidney Disease (CKD) (see, e.g., Definition_of_CKD11 at 27 at § 1.2.3, Table 5 at 27, reproduced below):
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The reference to a “UACR greater than 300 mg/g” defines a population of patients with Stage G4 CKD (see, e.g., Definition_of_CKD at 27 at § 1.2.3, Table 5 at 27) that also have high levels of albuminuria (see, e.g., Definition_of_CKD at 21 at col II at § “Kidney Damage” to 22 at col II at final bullet), wherein an ACR (UACR) of ≥ 30 mg/g (or 3 mg/mmol) is understood to be indicative of Chronic Kidney Disease (CKD) and/or kidney damage12, and an ACR (UACR) of 30-300 mg/g (3-30 mg/mmol) is “microalbuminuria” or “moderately increased” Albuminuria, and >300 mg/g (>30 mg/mmol) is considered “severely increased” Albuminuria or “macroalbuminuria” (see, e.g., Definition_of_CKD at Table 3 at 20). Accordingly, patients that simultaneously have both a “[UACR] greater than 300 mg/g” and also an “[eGFR] between 15-29 mL/min/l.73 m2” define a G4/A3 patient population. This is pertinent because CKD patients are routinely divided into only eighteen groups based upon the measurement of albuminuria (i.e., UACR) and eGFR (see, e.g., Definition_of_CKD at Figure 9 at page 33). Critically, the genus of patients having an “[UACR] greater than 300 mg/g” (i.e., “A3” patients) encompasses three distinct subpopulations of patients, namely G3a/A3, G3b/A3, and G4/A3 patients (see id). These subpopulations are not identical or synonymous with the genus of patients having an “[eGFR] between 15-29 mL/min/l.73 m2” (i.e., “G4” patients), which includes the subpopulations of G4/A1, G4/A2, and G4/A3 patients (see, e.g., Definition_of_CKD at Figure 9 at page 33). Therefore, the only subpopulation of patients that simultaneously have both a “[UACR] greater than 300 mg/g” and also an “[eGFR] between 15-29 mL/min/l.73 m2” are the G4/A3 subpopulation as shown in the modified reproduction of Figure 9 of Definition_of_CKD below:
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Accordingly, the claim scope is specifically directed to patients within the G4/A3 patient subpopulation of CKD patients13. Accordingly, the preamble reference to “CKD” is redundant in view of the requirements pertaining to eGFR and UACR set forth in the “wherein” clause. Furthermore, all patients having Stage 4 Chronic Kidney Disease (CKD) are “in need thereof” of treatment for CKD, regardless of whether or not they also have T2DM.
Therapeutic compound: The administered compound is understood to be Dulaglutide, which is understood to be CAS NO. 923950-08-7, and Dulaglutide comprises instant SEQ ID NO: 1 (see, e.g., Spec. filed 11/21/2019 at 5 at lines 8-35).
Active method steps: The active “hand-of-man” steps include administration of 1.5 mg of Dulaglutide to the patient, via in route of administration, once weekly, for at least 26 weeks (see, e.g., amended claims 42). Recitations of intended or expected results are not active method steps.
Duration of treatment: Amended claim 42 now recites that the duration of treatment is “at least 26 weeks” (see, e.g., amended claim 42 as filed 12/17/2025)14.
Route of administration: Claim 42 recites “administering to the subject”. Accordingly, the pending claim scope is understood to fully encompass any route of administration (i.e., oral, subcutaneous, intramuscular, anal, topical, sublingual, IV, etc.).
“Wherein” clauses reciting intended or expected results: Amended claim 42 as filed 12/17/2025 now recites “wherein” clauses:
….wherein the: (b) improved glycemic control at 26 weeks is characterized by a percent HbA1c reduction of at least 1%; (c) attenuated rate of eGFR decline at 26 weeks is characterized by a reduction in eGFR of not more than 3.5 mL/min/1.73m²: and (d) reduced UACR at 26 weeks is characterized by a UACR reduction of at least 28%.
These “wherein” clauses do not recite nor require any additional steps to be performed, or alter any active method step (i.e., route of administration, dosage, dosage frequency, administered compound, patient population, etc. are not impacted by the “wherein” clauses). Accordingly, the “wherein” clauses equivalent to
.....wherein the improved glycemic control at 26 weeks is characterized by a percent HbA1c reduction of at least 1%;
.....wherein the attenuated rate of eGFR decline at 26 weeks is characterized by a reduction in eGFR of not more than 3.5 mL/min/1.73 m2; and
.....wherein the reduced UACR at 26 weeks is characterized by a UACR reduction of at least 28%; and
are understood to be recitations of the expected and intended result of performing the positively recited method steps set forth in the body of amended claim 42 (see, e.g., MPEP § 2111.04(I), noting that the court has previously held that a “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited”). Accordingly, the performance of the active method steps of independent claim 42 for the duration of 26 weeks as required by amended claim 42 is understood to necessarily, implicitly, and/or inherently satisfy the “wherein” clauses of amended claim 42, because such “wherein” clauses are understood to recited intended and expected results achieved by the positively recited active method steps “at 26 weeks” (see, e.g., MPEP § 2111.04(I)).
“Wherein” clauses reciting intended or expected results: Claim 59 differs from amended claim 42 by the recitation of “wherein” clauses. The “wherein” clause is understood to be a recitation of intended and expected results fully satisfied by the performance of the active method steps set forth in the body of amended claim 42. Accordingly, claim 59 is rejected for the reasons applicable to claim 42 (see, e.g., MPEP § 2111.04(I), noting that the court has previously held that a “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited”).
Additional claim interpretations are set forth below.
Withdrawn Claim Rejections
The rejection of claim 42 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 amendments to claim 42 as filed 12/17/2025.
The rejection of claims 47, 49, 51-52, and 55-56 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form, is withdrawn as moot in view of the cancellation of claims 47, 49, 51-52, and 55-56 in the Reply filed 12/17/2025.
Revised Claim Rejections as Necessitated by Applicant’s Amendments
Claim Rejections - 35 USC §102 or §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 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 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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(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.
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.
[Prior Art Rejection 01]
Claims 42 and 59 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Tuttle15 as evidenced by Definition_of_CKD16.
Claim Interpretation: The applicable claim interpretation has been set forth in a separate section above, which is incorporated into the instant rejection. Additional claim interpretations are set forth below. Per MPEP §§ 2131.03(I)-(II), prior art that teaches a range overlapping the claimed range anticipates if the prior art range discloses the claimed range with “sufficient specificity”, and “[a] 35 U.S.C. 102 and 103 combination rejection is permitted if it is unclear if the reference teaches the range with "sufficient specificity."
Regarding instant claims 42 and 59, Tuttle discloses the existence of clinical trials wherein the trials included a treatment regimen wherein patients with Type 2 Diabetes (T2D) and Chronic Kidney Disease were administered 1.5 mg of dulaglutide weekly, for a duration of at least 26 weeks (see, e.g., Tuttle at title, abs, 437 at col I at § 2, Table 1 on 438, Fig. 1 on 439). Tuttle identifies that among the patients treated, multiple patients had T2D (see, e.g., Tuttle at title, abs), a eGFR (CKD-EPI) <60 ml/min/1.73 m2, and a UACR > 300 mg/g (see, e.g., Tuttle at 437 at col I at § 2, Table 1 on 438, Fig. 1 on 439; see also id. at 440 at col I at 1st to 2nd full ¶¶).
The prior art is silent regarding the newly added limitation requiring “an eGFR of 15-29 mL/min/1.73m2”.
Regarding anticipation: Per MPEP §§ 2131.03(I)-(II), prior art that teaches a range overlapping the claimed range anticipates if the prior art range discloses the claimed range with “sufficient specificity”. Here, the range of “eGFR (CKD-EPI) <60 ml/min/1.73 m2” (see, e.g., Tuttle at 437 at col I at § 2, Table 1 on 438, Fig. 1 on 439; see also id. at 440 at col I at 1st to 2nd full ¶¶) necessarily overlaps the claimed range of “an eGFR of 15-29 mL/min/1.73m2”. Therefore, the issue is whether or not the “overlap” is with “sufficient specificity” to constitute anticipation. MPEP § 2131.03(II) identifies that “sufficient specificity” is “similar to that of ‘clearly envisaging’ a species from a generic teaching” per MPEP § 2131.02. Per MPEP § 2131.02(III), identifies that "how one of ordinary skill in the art would understand the relative size of a genus or species in a particular technology is of critical importance", and that “[o]ne of ordinary skill in the art must be able to . . . write the name of each of the compounds included in the generic formula before any of the compounds can be ‘at once envisaged’” (see, e.g., MPEP § 2131.02). Here, the range of “<60 ml/min/1.73 m2” would have been reasonably interpreted by one of ordinary skill in the art to refer to four well-known, established, defined, and finite stages of CKD, namely stage G3a,G3b, G4, and G5:
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(see, e.g., Definition_of_CKD at 27 at § 1.2.3, Table 5 at 27)
Furthermore, Tuttle explicitly identifies that patients with “T2D and moderate or severe CKD” were under evaluation (see, e.g., Tuttle at 440 at col I at 3rd full ¶). Accordingly, in the present context, the range of “<60 ml/min/1.73 m2” would have been “sufficiently specific” for one of ordinary skill in the art to readily understand and appreciate that the author was encompassing four stages of CKD, including stage G4, which corresponds exactly to a range of 15-29 ml/min/1.73 m2. Therefore, in this context, the overlapping range taught by the prior art discloses the claimed range with “sufficient specificity” to constitute anticipation because one or ordinary skill in the art would readily appreciate that “<60 ml/min/1.73 m2” is simply an abbreviated reference encompassing the four finite patient populations having either stage G3a, G3b, G4, or G5 CKD.
Regarding obviousness: Per MPEP §§ 2131.03(I)-(II), prior art that teaches a range overlapping the claimed range anticipates if the prior art range discloses the claimed range with “sufficient specificity”, and “[a] 35 U.S.C. 102 and 103 combination rejection is permitted if it is unclear if the reference teaches the range with "sufficient specificity." Here, regardless of anticipation, the disclosure of the range of “eGFR (CKD-EPI) <60 ml/min/1.73 m2” necessarily overlaps the claimed range of “an eGFR of 15-29 mL/min/1.73m2” (see, e.g., Tuttle at 437 at col I at § 2, Table 1 on 438, Fig. 1 on 439; see also id. at 440 at col I at 1st to 2nd full ¶¶). Per MPEP § 2144.05(I), in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. Furthermore, it is well-within the ordinary skill in the art to perform a known method upon a known patient population using a known compound at a known concentration; furthermore, the predicted and expected outcome is the treatment of patients with T2DM and either stage 3a, 3b, 4, or 5 CKD, wherein such patients would desirably exhibit decreased albuminuria (see, e.g., Tuttle at 440 at col I), and wherein such treatment would reasonably be predicted to “exert long-term renoprotective effects” (see, e.g., Tuttle at 439 at col II at 1st full ¶). Furthermore, Tuttle explicitly teaches that such treatments are actively considered for patients with severe CKD (see, e.g., Tuttle at 440 at 2nd full ¶).
Accordingly, claims 42, 47, 49, 51-52, 55-56, and 59 are rejected under 35 U.S.C. 102(a)(1) as anticipated or, in the alternative, under 35 U.S.C. 103 as obvious.
[Prior Art Rejection 02]
Claims 42 and 59 are rejected under 35 U.S.C. 103 as being unpatentable over NCT01621178_2016022517 in view of Definition_of_CKD18.
Claim Interpretation: The applicable claim interpretation has been set forth in a separate section above, which is incorporated into the instant rejection. Additional claim interpretations are set forth below.
NCT01621178_20160225 refers to the NCT01621178 clinical trial as it was published and publicly available upon February 25, 2016. Regarding claims 42 and 59, the reference pertains to and discloses a clinical trial methodology, wherein the effect of administering 1.5 mg dulaglutide once-weekly for 26 weeks to patients with both Type 2 diabetes and “moderate to severe” Chronic Kidney disease was evaluated (see, e.g., Primary Reference at 3 at § Study Identification, 4 at § Study Description and § Conditions; 4 at § Arms and Interventions; 4-5 at § Outcome Measures). The patient population having “moderate to severe” Chronic Kidney disease is explicitly identified as patients having an eGFR of ≥15 to <60 (mL/min)/1.73 m2 (see, e.g., id. at 6 at § Eligibility).
The prior art of NCT01621178_20160225 differs from the instant claims as follows: Although the primary reference discloses a method of administering 1.5 mg dulaglutide once-weekly for 26 weeks to patients with both Type 2 diabetes and “moderate to severe” Chronic Kidney disease (e.g., patients having an eGFR of ≥15 to <60 (mL/min)/1.73 m2), the primary reference is silent regarding the specific patient population having “an eGFR of 15-29 mL/min/1.73m2” and a “UACR greater than 300 mg/g” as presently required by claim 42. However, such differences would be obvious.
Regarding instant claim 42 and the range of “an eGFR of 15-29 mL/min/1.73m2”, the primary reference explicitly teaches the overlapping range of patients having an eGFR of ≥15 to <60 (mL/min)/1.73 m2 (see, e.g., Primary Reference at 6 at § Eligibility). Per MPEP § 2144.05(I), “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. Furthermore, an artisan would readily realize, interpret, and understand that the reference to an eGFR of ≥15 to <60 (mL/min)/1.73 m2 in the Primary Reference is an abbreviated manner to collectively reference three, finite, and well-known categories of patients in the art, namely those having stages G3a,G3b, and/or G4 CKD:
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(see, e.g., Definition_of_CKD at 27 at § 1.2.3, Table 5 at 27)
This is pertinent, because in view of this disclosure, an artisan would have at once envisaged that the disclosed methodology should be applied to patients having T2DM and either Stage G3a,G3b, or G4 CKD (see Table above). Therefore, because the prior art discloses an overlapping range of eGFR corresponding specifically to only three well-known patient populations, the limitation regarding eGFR ranges at instant claim 42 is prima facie obvious in view of the prior art and does not constitute a point of novelty.
Regarding instant claim 42 and a “UACR greater than 300 mg/g”, although the Primary Reference does not positively require treated patients to have a “UACR greater than 300 mg/g”, the Primary Reference does inform artisans that a “UACR greater than 300 mg/g” is not an exclusion criterion (see, e.g., id. at 6 at § Eligibility). Therefore, such patients are not excluded from the prior art methodology for treating patients having T2DM and severe CKD. Furthermore, it would have been obvious to treat patients having T2DM, an eGFR of ≥15 to <60 (mL/min)/1.73 m2, and a “UACR greater than 300 mg/g” in view of the collective teachings of the Primary Reference and Definition_of_CKD because the prognosis of CKD was routinely understood to be classified in the CKD arts by eGFR and UACR rates:
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The image shown above is modified from the secondary reference (see, e.g., Definition_of_CKD at Figure 9 at page 33), and shows that CKD patients are typically divided into only eighteen groups based upon the measurement of albuminuria (i.e., UACR) and GFR (see, e.g., Definition_of_CKD at Figure 9 at page 33). However, in combination with the teachings of the Primary Reference, which directs artisans to patients having T2DM and an eGFR of ≥15 to <60 (mL/min)/1.73 m2, an artisan would readily appreciate that the Primary Reference directs artisans to treat only nine specific groups of patients, namely patients having either category G3a, G3b, or G4 GFR, and patients having either A1, A2, or A3 albuminuria categories (e.g., G3a/A1, G3a/A2, G3a/A3, G3b/A1, G3b/A2, G3b/A3, G4/A1, G4/A2, or G4/A3). Accordingly, one of ordinary skill in the prior art would readily appreciate and understand that the Primary Reference provided guidance directing an artisan to treat patients categorized as G4/A3, which corresponds to patients having an “eGFR of 15-29 mL/min/1.73m2” and also a “UACR greater than 300 mg/g” as presently required by claim 43 (see, e.g., Definition_of_CKD at Figure 9 at page 33; see also id. at Table 6 on 28, Table 7 on 31, Fig. 8 on 31). In sum, one of ordinary skill in the CKD arts would readily appreciate that the treatment of patients having an eGFR of ≥15 to <60 (mL/min)/1.73 m2 as taught and suggested by the prior art would necessarily include patients having normal Albuminuria (i.e., <30 mg/g; A1), moderate Albuminuria (i.e., 30-300 mg/g; A2), or else severe albuminuria (i.e., >300 mg/g; A3) (see, e.g., Definition_of_CKD at Figure 9 at page 33; see also id. at Table 6 on 28, Table 7 on 31, Fig. 8 on 31). Therefore, an artisan would readily understand that the methods of the primary reference are applicable to and intended to treat nine categories of CKD patients, including patients categorized as G4/A3, which corresponds to patients having an “eGFR of 15-29 mL/min/1.73m2” and also a “UACR greater than 300 mg/g” as presently required by claim 42 and its dependents.
Regarding the “wherein” clauses at claims 42 and 59, these “wherein” clauses are understood to be recitations of the expected and intended result of performing the positively recited method steps set forth in the body of instant claim 42 (see, e.g., MPEP § 2111.04(I), noting that the court has previously held that a “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited”). Therefore, the “wherein” clauses of instant claim 42 and 59 are understood to be fully satisfied by any prior art that anticipates or renders obvious the positively recited method steps set forth at instant claim 42, namely the steps of administering 1.5 mg dulaglutide once-weekly for 26 weeks to patients with both Type 2 diabetes, and “an eGFR of 15-29 mL/min/1.73m2” and a “UACR greater than 300 mg/g”. Therefore, as noted above, the treatment of patients categorized as G4/A3 using the methodology taught and suggested by the primary reference would necessary satisfy the intended and expected results recited at the newly added “wherein” clauses of amended claim 42 and 59, presuming the claims are enabled (currently, the claims are presumed enabled).
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 reasons:
First, the claimed invention is the combination of prior art elements (i.e., 1.5 mg dulaglutide) according to known methods (i.e., administering once-weekly for at least 26 weeks) in a known patient population (i.e., patients with both Type 2 diabetes and Chronic Kidney disease) in order to predictably yield expected results, namely the treatment of Type 2 diabetes exactly as taught and suggested in view of the prior art reference (see, e.g., MPEP § 2143(I)(A), (C), (D), and (E)). Furthermore, each element merely performs its art-recognized function in combination as it does separately.
In addition, or alternatively, the invention is “Obvious to try” because it is the application of a known prior art method taught by the primary reference to one of only nine finite categories of CKD patients as identified in view of the primary and secondary references (e.g., the treatment of patients categorized as G4/A3), and the Primary Reference explicitly provides a motivation, suggestion and teaching that all patients having an eGFR of ≥15 to <60 (mL/min)/1.73 m2 (i.e., all nine categories as identified by the secondary reference) should be treated in the disclosed manner (i.e., dulaglutide administered to patients with severe CKD and T2DM using a dosing regimen of 1.5 mg dulaglutide once weekly for 26 weeks), wherein such treatment would yield predictable results, namely the treatment of patients having T2DM and severe CKD (see, e.g., MPEP § 2143(I)(E), (G)).
Furthermore, there would be a reasonable expectation of success because it is well-within the ordinary skill in the art to administer a known compound to a known patient population at a known dosage at a known dosing frequency using a known administration route to predictably obtain the exact results taught, disclosed, or otherwise suggested by the prior art - namely the treatment of T2D in patients having severe CKD.
Accordingly, claims 42 and 59 are rejected as obvious.
[Prior Art Rejection 03]
Claims 42 and 59 are rejected under 35 U.S.C. 103 as being unpatentable over Poster111419 in view of Loghin88020 and Definition_of_CKD21.
Claim Interpretation: The applicable claim interpretation has been set forth in a separate section above, which is incorporated into the instant rejection. Additional claim interpretations are set forth below.
Regarding instant claims 42 and 59, Poster1114 identifies an art-recognized problem, namely that some incretin-based therapies have been associated with “acute decreases in kidney function” (see, e.g., Poster1114 at page A286 at col I). Accordingly, Poster1114 addresses this art recognized problem by determining the effect of Dulaglutide (1.5 mg) on kidney function (see id). To this end, Poster1114 discloses and summarizes clinical trial data wherein once-weekly dulaglutide was administered to patients having Type 2 diabetes (T2D) at a concentration of 1.5 mg for at least 26 weeks (see, e.g., Poster1114 at page A286 at col I). UACR and eGFR were explicitly monitored (see, e.g., Poster1114 at page A286 at col I). The outcome of the treatment established that dulaglutide treatment in T2D patients (i) did not alter kidney function (i.e., progression of renal deterioration did not increase), (ii) did not lead to increased adverse events (see, e.g., Poster1111 at page A286 at col I), but (iii) dulaglutide treatment was reported as desirably lowering UACR values in T2D patients (see, e.g., Poster1111 at page A286 at col I).
The prior art of Poster1114 differs from the instantly claimed invention as follows: The patient population treated by Poster1114 using once-weekly dulaglutide was not explicitly disclosed as having (a) an eGFR between 15-29 (mL/min)/1.73 m2 and (b) a UACR greater than 300 mg/g as required by the pending claims.
Therefore, the pertinent issue is whether or not it would be obvious to extend the treatment disclosed by Poster1114 to such patients having an eGFR between 15-29 (mL/min)/1.73 m2 and a UACR greater than 300 mg/g (e.g., patients with severe CKD), with a reasonable expectation of treating T2D without harming kidney function, while improving UACR values.
Loghin880, like Poster1114, discloses that dulaglutide was administered to “special populations” of patients with Type 2 Diabetes (T2D) at a concentration of 1.5 mg (see, e.g., Loghin880 at S358 at col I at Abstract 880); however, Loghin880 explicitly tested dulaglutide in subjects with “mild, moderate, and severe renal impairment”, including end stage renal disease (see, e.g., Loghin880 at S358 at col I at Abstract 880). Loghin880 further provides a clear teaching, suggestion, and motivation to treat patients with mild, moderate, and severe renal impairment by stating that “Dulaglutide can be administered once weekly to patients with renal or hepatic impairment, without dose adjustment” (see, e.g., Loghin880 at S358 at col I at Abstract 880, emphasis added).
Accordingly, in view of Poster1114 and Loghin880, an artisan would readily appreciate that the methodology of Poster1114 could be extended “without dose adjustment” to patients having “mild, moderate, or severe renal impairment” (see, e.g., Loghin880 at S358 at col I at Abstract 880).
This raises a question, namely “how would an artisan interpret the terms ‘mild, moderate, and severe’ in the context of renal impairment?” This question is fully addressed by Definition_of_CKD. As noted by Poster1114, kidney function is measured using UACR and eGFR (see, e.g., Poster1111 at page A286 at col I). Definition_of_CKD identifies that one of ordinary skill in the CKD arts would interpret “mild, moderate, and severe renal impariment” would be reasonably understood in view of UACR and eGFR to include a GFR value ranging from 15-89 (mL/min)/1.73 m2 (see, e.g., Definition_of_CKD at Table 5 on 27) and/or an albuminuria (urine ACR) value ranging from 30-300 and >300 (see, e.g., Definition_of_CKD at Table 6 on 28; see also id. at Table 3, noting the descriptions for microalbuminuria and macroalbuminuria). Notably, Definition_of_CKD identifies that CKD patients are typically categorized into only eighteen finite subgroups depending upon the UACR and eGFR measurements (see, e.g., Definition_of_CKD at Table 6 on 28, Table 7 on 31, Fig. 8 on 31, Figure 9 at page 33; see esp. id. at Fig. 9 on page 33).
In sum, in view of Poster1111 and Loghin880, an artisan would readily appreciate that once-weekly dulaglutide could be administered to patients having Type 2 diabetes (T2D) and “mild, moderate, and severe renal impairment” at a concentration of 1.5 mg for at least 26 weeks (see, e.g., Poster1114 at page A286 at col I; see, e.g., Loghin880 at S358 at col I at Abstract 880), to predictably treat T2D and also lower UACR levels (see, e.g., Poster1111 at page A286 at col I), “without dose adjustment” (see, e.g., Loghin880 at S358 at col I at Abstract 880). Furthermore, in view of Definition_of_CKD, an artisan would readily appreciate that such patients having “mild, moderate, and severe renal impairment” necessarily included patients having a GFR value ranging from 15-89 (mL/min)/1.73 m2 (see, e.g., Definition_of_CKD at Table 5 on 27) and/or an albuminuria (urine ACR) value ranging from 30-300 and >300 (see, e.g., Definition_of_CKD at Table 6 on 28; see also id. at Table 3, noting the descriptions for microalbuminuria and macroalbuminuria). Critically, these ranges overlap with the instantly claimed ranges, and, per MPEP § 2144.05(I), “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”.
Regarding the “wherein” clauses at claims 42 and 59, these “wherein” clauses are understood to be recitations of the expected and intended result of performing the positively recited method steps set forth in the body of instant claims 42 and 59 (see, e.g., MPEP § 2111.04(I), noting that the court has previously held that a “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited”). Therefore, instant claim 42 and 59 are understood to be fully satisfied by any prior art that anticipates or renders obvious the positively recited method steps set forth in the body of instant claims 42, namely the steps of administering 1.5 mg dulaglutide once-weekly for 26 weeks to patients with both Type 2 diabetes, and “an eGFR of 15-29 mL/min/1.73m2” and a “UACR greater than 300 mg/g”. Therefore, as noted above, the treatment of all patients with “mild, moderate, and severe renal impairment” using the methodology taught and suggested by the primary reference would necessary satisfy the intended and expected results recited at instant claims 42 and 59, presuming the claims are enabled (currently, the claims are presumed enabled).
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 reasons:
First, the claimed invention is obvious because it is merely the combination of prior art elements (i.e., the known T2D medication of dulaglutide; the known dulaglutide dosage of 1.5 mg; and the known T2D patient subpopulation having mild, moderate, and severe renal impairment) according to the known methods disclosed by Poster1114 (i.e., >26 weeks of administering once-weekly 1.5 mg dulaglutide administered to T2D patients), to yield a predictable result, namely treatment of T2D as well as desirably lowering UACR values as suggested by the primary reference. Furthermore, each element merely performs the same function in combination as taught in the art (see, e.g., MPEP § 2143(I)(A), (G)).
Second, the claimed invention is the simple substitution of one known T2D patient subpopulation having severe renal impairment (i.e., G4/A3 patients) in place of another T2D patient subpopulation in the Poster1114 method, wherein such substitution would predictably yield the treatment of the T2D patients as well as lowering UACR values in the renal impaired population, exactly as suggested by Loghin880 and the primary reference (see, e.g., MPEP § 2143(I)(B), (G)).
Third, the invention is the use/application of the known methodology of Poster1114 for treating T2D to treat other T2D patients having severe renal impairment (i.e., G4/A3 patients) in the same way, wherein such treatment would be predicted to desirably lower UACR values in such renal impaired patients, and wherein the prior art of Loghin880 provides a direct teaching, suggestion, and motivation directing and artisan to treat all such renal-impaired patients with Dulaglutide “without dose adjustment” (see, e.g., MPEP § 2143(I)(C), (D), (G)).
Furthermore, there would be a reasonable expectation of success because it is well-within the ordinary skill in the art to administer a known compound to a known patient population at a known dosage using a known administration route to predictably obtain the exact results taught, disclosed, or otherwise suggested by the prior art - namely the treatment of T2D in patients having mild, moderate, or severe renal impairment, wherein such treatment would be predicted to desirably lower UACR values in such patients.
Accordingly, claims 42 and 59 are rejected as obvious.
Response to Arguments
Applicant's arguments filed 12/17/2025 have been fully considered but they are not persuasive. Arguments directed to withdrawn rejections are moot. Remaining applicable arguments are addressed below.
Examiner’s prior responses to the arguments of record as set forth in the parent application remain pertinent and are incorporated herein,22,23,24. The prior prosecution history including statements and admissions made therein remains relevant25.
To date, zero evidence of unexpected results commensurate in scope with the requirements of MPEP §§ 716, 716.01, and 716.02 have been placed on record26. Furthermore, data showing that a prior art treatment yielded the exact results suggested by the prior art weighs in favor of a determination of obviousness (see, e.g., MPEP § 716.02(c)(II)).
As evidenced by the rejections above, it is the Examiner’s position that extending a prior art method taught for use in the treatment of T2D or CKD to a subpopulation within the broader genus of patients, by administering the same, known compound at the same, known amount via the same, known administration route for the same, known duration to achieve the same benefits taught by the prior art, is anticipated and/or obvious in view of the prior art. It is well-established, that recognizing an additional advantage that would flow naturally from following the suggestions and guidance of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985); see also MPEP § 2144(IV), noting that “it is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant).
35 USC 102/103 Rejection in view of Tuttle as evidenced by CDK
It is the Examiner’s understanding that Applicant alleges that the rejection should be withdrawn in view of the declaration of Fady Botros “a copy of which is attached hereto as Appendix 1”, and states that “Tuttle is not prior art pursuant to 35 U.S.C. § 102(b)(1)(A)” (see, e.g., Reply filed 12/17/2025 at 5 at 1st full ¶). This is not persuasive because 35 U.S.C. § 102(b)(1)(A) is not applicable since (i) priority to Provisional 62513556 (filed 6/01/2017) has been denied, (ii) the applicable priority date corresponding to PCT/US2018/034278 is 5/24/2018, and (iii) Tuttle27 was published Oct. 21, 2016. Accordingly, the prior art reference was published more than one year prior to the effective filing date. Accordingly, the rejection is maintained.
35 USC 103 Rejections (Addressed Collectively by Applicant)
It is the Examiner’s understanding that Applicant addresses both rejections under 35 USC 103 collectively (see, e.g., Reply filed 12/17/2025 at 5 at § “D” to p. 8 at final ¶).
Recitations of intended and expected results of positively recited method steps are not limiting: It is the Examiner’s understanding that Applicant alleges that a prima facie case of obviousness has not been established because the rejections fail to address the “claim limitation requiring ‘an attenuated rate of estimated glomerular filtration rate (eGFR) decline’" (see, e.g., Reply filed 12/17/2025 at 6 at 3rd full ¶) or other recitations of intended or expected results (see, e.g., Reply filed 12/17/2025 at 7 at 1st to 2nd full ¶¶, referring to “wherein” clauses and recitations of intended or expected results of positively recited active method steps). This limitation is explicitly addressed in the claim interpretation section, which addresses the “wherein” clauses, and recitations of intended and expected results. Specifically, per MPEP § 2111.04(I) explains that “claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure; furthermore, MPEP § 2111.04(I), notes that clauses in a method claim are not given weight when they simply express the intended result of a process step positively recited. Here, the language relied upon by the Applicant is understood to merely be a recitation of an intended or expected result fully satisfied by the administration of 1.5 mg of dulaglutide once a week for 26 weeks to a subject having type 2 diabetes mellitus and chronic kidney disease; critically, the prior art teaches or renders obvious such treatment as explained in the rejections above.
Applicant has a different rationale for arriving at the instant invention: It is the Examiner’s understanding that Applicant identifies that their rationale for arriving at the claimed invention differs from the rationale relied upon by the Examiner to establish obviousness (see, e.g., Reply filed 12/17/2025 at 6 at 3rd full ¶, referring to “an attenuated rate of estimated glomerular filtration rate (eGFR) decline’”; see also Reply filed 12/17/2025 at 7 at 1st to 2nd full ¶¶, referring to “wherein” clauses and recitations of intended or expected results of positively recited active method steps). Examiner notes that this is not persuasive because an examiner may support a determination of obviousness by relying upon a rationale that differs from the Applicant’s rationale (see, e.g., MPEP § 2144(IV)). Here, the Examiner’s rationales are acknowledged by the Applicant and undisputed (see, e.g., Reply filed 12/17/2025 at 7 at 1st full ¶ at final sentence), and have been explicitly identified in the rejection (i.e., under MPEP § 2143(I)(A), (B), (C), (D), and (G)), but Applicant fails to address or specifically dispute these rationales supporting a determination of obviousness. Accordingly, it is neither disputed nor dispositive of obviousness that the Examiner did not support a rationale that was not actually relied upon to establish prima facie obviousness. However, obviousness does not require the Examiner to rely upon the Applicant’s rationale, and therefore arguments presupposing that the Examiner must utilize the Applicant’s rationale are not persuasive (see, e.g., MPEP § 2144(IV)).
Applicant alleges results that flow from following the teachings of the prior art: It is the Examiner’s understanding that Applicant alleges that a prima facie case of obviousness has not been established because the rejections fail to address the “claim limitation requiring ‘an attenuated rate of estimated glomerular filtration rate (eGFR) decline’" (see, e.g., Reply filed 12/17/2025 at 6 at 3rd full ¶; see also Reply filed 12/17/2025 at 7 at 1st to 2nd full ¶¶, referring to “wherein” clauses and recitations of intended or expected results of positively recited active method steps). These expected and predicted results are understood to necessarily and inherently occur upon treating patients with severe CKD and T2D with once weekly dulaglutide at a concentration of 1.5 mg for at least 26 weeks, which is rendered obvious in view of the prior art for reasons set forth above (see rejections above, and rationales supporting a determination of obviousness under MPEP § 2143(I)(A), (B), (C), (D), and (G)). Accordingly, at best the intended and expected result of “an attenuated rate of estimated glomerular filtration rate (eGFR) decline” corresponds to an additional advantage that would flow naturally from following the guidance of the prior art by treating patients with severe CKD and T2D with once weekly dulaglutide at a concentration of 1.5 mg for at least 26 weeks, exactly as taught and suggested by the prior art. Accordingly, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Allegations suggesting “lack of predictability” or “lack of reasonable expectation of success”: It is the Examiner’s understanding that Applicant is alleging a lack of predictability or otherwise a lack of reasonable expectation of success CDK (see, e.g., Reply filed 12/17/2025 at 6-7 at bridging ¶ to 7 at final ¶). This is not persuasive because the Applicant’s assertions do not reflect the proper legal standards for evaluating predictability. MPEP § 2143.02(II) explains that “[o]bviousness does not require absolute predictability”, but instead clarifies that only “at least some degree of predictability is required” (see, e.g., MPEP § 2143.02(II)). Here, the rejection explicitly addresses predictability and reasonable expectation of success, but Applicant fails to address the explicitly identified predicted and expected results set forth in the rejection. Here, the Examiner’s basis for “predictability” is merely based upon the presumption that the prior art is fully enabled (see, e.g., MPEP § 2121(I)) for all that it discloses (see, e.g., MPEP §§ 2123(I)-(II)). As explained at MPEP § 2143.02, predictability and reasonable expectation of success are satisfied when “all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art”. Here zero evidence of unexpected results commensurate in scope with the requirements of MPEP 716.02 have been set forth on record, all elements of the claimed invention were known in the prior art, one of ordinary skill was fully enabled to combined each component using routine methods in the biochemical arts per the guidance of the primary reference, and the elements would have merely performed their art-recognized, respective functions (see Rejection, above). Here, there is a reasonable expectation of successfully treating patients with severe CKD and T2D with once weekly dulaglutide at a concentration of 1.5 mg for at least 26 weeks exactly as taught and suggested by the prior art because such treatment merely administers a known drug at a known dosage to a known patient populations via a known route of administration for a known duration to obtain the exact results taught and disclosed by the prior art, namely the treatment of T2D in patients having severe CDK (see, e.g., Reply filed 12/17/2025 at 6-7 at bridging ¶). Accordingly, such arguments are not persuasive.
Allegations of unexpected results are not commensurate in scope with the requirements of MPEP §§ 716, 716.01, or 716.02: It is the Examiner’s understanding that Applicant is alleging unexpected results on the basis of the “previously submitted Botros Declaration attached hereto as Appendix 1” (see, e.g., Reply filed 12/17/2025 at 8 at § “b)”). To establish unexpected results, the allegations must be timely and supported by objective evidence (see, e.g., 37 C.F.R. 1.132; see MPEP §§ 716.01, 716.01(a), 716.01(c)); to be of probative value the proffered evidence must be related to the claimed invention (see MPEP §§ 716.01(b), discussing nexus requirement and noting that "[w]here the offered secondary consideration actually results from something other than what is both claimed and novel in the claim, there is no nexus to the merits of the claimed invention"); the evidence must establish that the expected results occur to an unexpected extent (see, e.g., MPEP § 716.02(a)(I)), on the basis of statistically and practically significant evidence (see, e.g., MPEP § 716.02(b)(I)), which is fully explained (see, e.g., MPEP § 716.02(b)(II)), commensurate in scope with the claimed invention (see, e.g., MPEP § 716.02(d)), and wherein a comparison of the claimed invention with the closest prior art of record is provided (see, e.g., MPEP § 716.02(e)). Furthermore, even if evidence satisfying MPEP §§ 716.02, 716.02(a), 716.02(b), 716.02(d), and 716.02(e) is set forth on record, such evidence may not be sufficient to rebut prima facie obviousness because the evidence of expected and unexpected results must be weighed (see, e.g., MPEP § 716.02(c)(I)) and the totality of the record considered (see, e.g., MPEP §§ 716.01(d), 716.02(f)), including teachings in the prior art and evidence of expected results which weigh in favor of a determination of obviousness (see, e.g., MPEP § 716.02(c)(II)). Here, the proffered data fails to satisfy the requirements of MPEP §§ 716, 716.01, or 716.02 for multiple reasons:
First, no “Appendix 1” was actually submitted in the Reply filed 12/17/2025. Per MPEP 201.06(c)(IX), Affidavits or declarations, such as those submitted under 37 CFR 1.130, 1.131 and 1.132 filed during the prosecution of the prior nonprovisional application do not automatically become a part of a continuation or divisional application filed under 37 CFR 1.53(b). Where it is desired to rely on an earlier filed affidavit or declaration, the applicant should make such remarks of record in the 37 CFR 1.53(b) application and include a copy of the original affidavit or declaration filed in the prior nonprovisional application. If Applicant would like the affidavit or declaration considered, Applicant must make such remarks of record in the 37 CFR 1.53(b) application and include a copy of the original affidavit or declaration filed in the prior nonprovisional application. Accordingly, such arguments are not persuasive at this time.
Second, presumably Applicant is referring to the Botros Declaration filed 4/24/2023 in the parent Application of 16/615,609, which was fully considered and not found persuasive for reasons of record, which are incorporated herein (see, e.g., Final Action in Application 16/615,609 mailed 5/30/2024 at pages 35-41, explaining why the Declaration and record were insufficient to establish unexpected results sufficient to rebut prima facie obviousness).
Third, the reasons of record are not fully repeated herein, but Examiner notes that a threshold requirement for unexpected results is to provide a comparison with the closest prior art of record (see, e.g., MPEP § 716.02(e)). Here, the closest prior art of record literally teaches and discloses the exact treatment regimen for treating T2D using 1.5 mg dulaglutide, once-weekly, for 26 or more weeks - and Applicant fails to provide a comparison of the claimed invention with the closest prior art at all, much less any difference between the prior art method and the claimed method. In the absence of such a comparison, the requirements of MPEP § 716.02 have not been satisfied.
Accordingly, to date, zero evidence of unexpected results commensurate in scope with the requirements of MPEP §§ 716, 716.01, and 716.02 have been placed on record28. Furthermore, data showing that a prior art treatment yielded the exact results suggested by the prior art weighs in favor of a determination of obviousness (see, e.g., MPEP § 716.02(c)(II)).
Applicant fails to address the merits of the rejections by identifying any elements of MPEP § 2143(I)(A), (B), (C), (D), or (G) that was not satisfied by the prior art. Accordingly, the rejections are maintained on these rationales.
Accordingly, all arguments raised by the Applicant have been fully considered but not found persuasive for reasons of record.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Davies29 identifies that Dulaglutide has a licensed dose of 0.75-1.5 mg for once weekly (“ow”) subcutaneous injections (see, e.g., Davies at Table 4 on 65), and that it may be used as a therapy in patients having an eGFR (mL/min/1.73 m2) of 45-59 or 30-44, which is identified as corresponding to Stage 3a and Stage 3b Chronic Kidney disease, respectively (see, e.g., Davies at Table 4 on 65). In addition, Davies identifies that the effect of 0.75-1.5 mg subcutaneous injections, once weekly, were being evaluated in CKD patients having stage 3a and stage 3b CKD circa 2016 (see, e.g., Davies at Table 4 on 65, 71 at col II at § Dulaglutide; see also id. at Table 8 referencing clinical trial NCT01621178).
Narva30 discusses diabetic kidney disease, chronic kidney disease, and the use of eGFR and UACR to measure kidney function (see, e.g., Narva at title, abs).
US 2007/0036806 (Feb. 15, 2007; cited in previous action) pertains to GLP-1 agonists, and notes that in the art, the phrase “effective amount” for “the treatment of diabetes is the quantity that would result in . . . a delay in the onset of diabetic complications such as . . . kidney disease” (see, e.g., US’806 at title, abs, ¶[0081]).
US 9186392 B2 (Nov. 17, 2015; cited in previous action) pertains to therapies comprising the administration of a GLP-1 receptor agonist, including dulaglutide (see, e.g., US’392 at abs, col 24 at lines 10-35) to patients, which are defined to include patients with renal impairment and albuminuria (see, e.g., US’392 at col 6 at line 29 to col 7 at line 10).
US 9259479 B2 discusses treatment for comorbid diabetes with Chronic Kidney Disease (see, e.g., US’479 at title, abs, claims).
Conclusion
No claims are allowed.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko G. Garyu can be reached at (571) 270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RANDALL L BEANE/Primary Examiner, Art Unit 1654
1 See, e.g., Response filed 6/08/2021 in US Application 16/615,609 at page 4.
2 See, e.g., Action mailed 7/16/2021 in US Application 16/615,609 at pages 2-3, 5-8.
3 See, e.g., Action mailed 4/07/2022 in US Application 16/615,609 at pages 2-3, 4-8.
4 See, e.g., Action mailed 10/24/2022 in US Application 16/615,609 at pages 3, 5-10.
5 See, e.g., Action mailed 5/30/2023 in US Application 16/615,609 at pages 2-3, 5-10.
6 See Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., 789 F. 3d 1335 (2015), at 1343, stating “We have said before, and reaffirm today, that past and future prosecution of related patents may be relevant to the construction of a given claim term”. 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”).
7 See Requirement mailed 3/21/2025 at 2-3, footnote on 2, 4 at final ¶, 6, 6-7 at bridging ¶.
8 NCT01621178 (ClinicalTrials.gov, A Study Comparing Dulaglutide With Insulin Glargine on Glycemic Control in Participants With Type 2 Diabetes (T2D) and Moderate or Severe Chronic Kidney Disease (CKD) (AWARD-7), Version February 25, 2016, 13 pages; hereafter “NCT01621178_20160225”; cited in IDS filed 5/10/2024 as cite No. 35)
9 Chapter 1: Definition and classification of CKD, Kidney Int Suppl (2011), vol. 3(1): 19–62 (2013 Jan; published online Dec. 28 2012; hereafter “Definition_of_CKD”; cited in IDS filed 5/10/2024 as cite No. 34).
10 See Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., 789 F. 3d 1335 (2015), at 1343, stating “We have said before, and reaffirm today, that past and future prosecution of related patents may be relevant to the construction of a given claim term”. 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”).
11 Chapter 1: Definition and classification of CKD, Kidney Int Suppl (2011), vol. 3(1): 19–62 (2013 Jan; published online Dec. 28 2012; hereafter “Definition_of_CKD”; cited in IDS filed 5/10/2024 as cite No. 34).
12 See, e.g., Definition_of_CKD at 21 at col II at § “Kidney Damage” to 22 at col II at final bullet, Table 2 at 20, Table 3 at 20.
13 Notably, no data of record appears to pertain specifically to this subpopulation, but rather the available data appears to be mixed with other subpopulations besides G4/A3 patients (e.g., G3a/A3 and G3b/A3 patient data appears to be reported collectively with G4/A3 patients without distinction).
14 Critically, the instant disclosure suggests that 26 weeks is the minimum duration possible (see, e.g., Spec. filed 11/29/2023 at 1-2 at bridging ¶, noting “within as short a period of time as 26 weeks”; see id. at 2 at lines 15-25, noting that “improvements . . . may be seen in as short a period of time as 6 months after initiation of treatment with dulaglutide”).
15 Tuttle et al. (Effects of once-weekly dulaglutide on kidney function in patients with type 2 diabetes in phase II and III clinical trials, Diabetes Obes Metab, vol. 19(3):436-441 and 10 pages of Supplemental (published online Oct. 21, 2016); hereafter “Tuttle”; cited in previous action)
16 Chapter 1: Definition and classification of CKD, Kidney Int Suppl (2011), vol. 3(1): 19–62 (2013 Jan; published online Dec. 28 2012; hereafter “Definition_of_CKD”; cited in IDS filed 5/10/2024 as cite No. 34).
17 NCT01621178 (ClinicalTrials.gov, A Study Comparing Dulaglutide With Insulin Glargine on Glycemic Control in Participants With Type 2 Diabetes (T2D) and Moderate or Severe Chronic Kidney Disease (CKD) (AWARD-7), Version February 25, 2016, 13 pages; hereafter “NCT01621178_20160225”; cited in IDS filed 5/10/2024 as cite No. 35)
18 Chapter 1: Definition and classification of CKD, Kidney Int Suppl (2011), vol. 3(1): 19–62 (2013 Jan; published online Dec. 28 2012; hereafter “Definition_of_CKD”; cited in IDS filed 5/10/2024 as cite No. 34).
19 Tuttle et. al., Poster 1114-P: The Effects of Once-Weekly Dulaglutide on Kidney Function in Clinical Trials, Diabetes 2015 Jun; 64(Supplement 1): A286, https://doi.org/10.2337/db15-932-1471; cited in IDS filed 5/10/2024 as cite No. 38; hereafter “Poster1114”)
20 Abstracts of the 50th EASD Annual Meeting, Diabetologia, Vol. 57, Supplemental pages S1–S6 and S357-S360 (Aug. 19, 2014); cited in IDS filed 5/10/2024 as cite No. 37; hereafter “Loghin880”)
21 Chapter 1: Definition and classification of CKD, Kidney Int Suppl (2011), vol. 3(1): 19–62 (2013 Jan; published online Dec. 28 2012; hereafter “Definition_of_CKD”; cited in IDS filed 5/10/2024 as cite No. 34).
22 See, e.g., Action mailed 4/07/2022 in US Application 16/615,609 at pages 10-17, 19-22, and 27-36.
23 See, e.g., Action mailed 10/24/2022 in US Application 16/615,609 at pages 14-15, 20-21, 27-39.
24 See, e.g., Action mailed 5/30/2023 in US Application 16/615,609 at pages 22-41.
25 See Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., 789 F. 3d 1335 (2015), at 1343, stating “We have said before, and reaffirm today, that past and future prosecution of related patents may be relevant to the construction of a given claim term”. 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”).
26 To establish the existence of unexpected results sufficient to rebut a determination of prima facie obviousness, the proffered evidence must at least establish unexpected results (see, e.g., MPEP § 716.02(a)(I)), on the basis of statistically and practically significant evidence (see, e.g., MPEP § 716.02(b)(I)), which is fully explained (see, e.g., MPEP § 716.02(b)(II)), commensurate in scope with the claimed invention (see, e.g., MPEP § 716.02(d)), and wherein such results provide a comparison of the claimed invention with the closest prior art of record (see, e.g., MPEP § 716.02(e)).
27 Tuttle et al. (Effects of once-weekly dulaglutide on kidney function in patients with type 2 diabetes in phase II and III clinical trials, Diabetes Obes Metab, vol. 19(3):436-441 and 10 pages of Supplemental (published online Oct. 21, 2016); hereafter “Tuttle”; cited in previous action)
28 To establish the existence of unexpected results sufficient to rebut a determination of prima facie obviousness, the proffered evidence must at least establish unexpected results (see, e.g., MPEP § 716.02(a)(I)), on the basis of statistically and practically significant evidence (see, e.g., MPEP § 716.02(b)(I)), which is fully explained (see, e.g., MPEP § 716.02(b)(II)), commensurate in scope with the claimed invention (see, e.g., MPEP § 716.02(d)), and wherein such results provide a comparison of the claimed invention with the closest prior art of record (see, e.g., MPEP § 716.02(e)).
29 Davies et al., The treatment of type 2 diabetes in the presence of renal impairment: what we should know about newer therapies, Clinical Pharmacology: Advances and Applications vol. 8:61-81 (June 23, 2016); hereafter “Davies”; cited in previous action)
30 Narva et al. Laboratory Assessment of Diabetic Kidney Disease, Diabetes Spectr., vol. 28(3): 162–166 (Aug. 2015), doi: 10.2337/diaspect.28.3.162; hereafter “Narva”; cited in IDS filed 5/10/2024 as cite No. 36)