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 .
DETAILED ACTION
This office action is in response to applicant’s reply filed on January 13, 2026.
Status of Claims
Amendment of claims 1, 39, 116, 186-187, and cancellation of claims 4, 13, 33-34, 60, 110, 121, 148-150, 153 and 156-157
Claims 1, 31-32, 39, 116, 125, 128, 160-161, 164-165 and 186-187 are currently pending and are the subject of this office action.
Claims 1, 31-32, 39, 116, 125, 128, 160-161, 164-165 and 186-187 are presently under examination.
Priority
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Rejections and/or Objections and Response to Arguments
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated (Maintained Rejections and/or Objections) or newly applied (New Rejections and/or Objections, Necessitated by Amendment or New Rejections and/or Objections not Necessitated by Amendment). They constitute the complete set presently being applied to the instant application.
Responses to Applicant’s arguments have been addressed immediately after the corresponding rejections, or in the section: Withdrawn Rejections and/or Objections, if the rejection was withdrawn.
Claim Rejections - 35 USC § 103 (New Rejection Necessitated by Amendment).
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention 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.
1) Claim(s) 1, 31-32, 39 and 116, is/are rejected under 35 U.S.C. 103 as being unpatentable over Cases et. al. (Drugs of the Future (2018) 43:23-33).
For claims 1 and 39, Cases teaches a method of treating anemia comprising administering to a subject suffering from anemia with CKD a dose of Vadadustat (instant compound 1) for a period of at least 52 weeks (1 year) or a minimum of 1 year (52 weeks) (see summary on page 23 and see page 27, left column, first paragraph under “Vadadustat”).
Cases teaches that in Phase II clinical trial patients were previously treated with ESA (see page 27, right column, second paragraph and beginning of third paragraph).
Cases does not teach for the treatment lasting for at least about 53-260 weeks. However, as mentioned above Cases teaches that the treatment last minimum 52 weeks which overlaps with the instantly claimed range.
MPEP 2144.05 states: In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Even a slight overlap in range establishes a prima facie case of obviousness. In re Peterson, 65 USPQ2d 1379, 1382 (Fed. Cir. 2003).
Cases does not teach that the ESA treatment occurs within about six or eight weeks prior to administering Compound 1 (Vadadustat). However, dose regimen optimization is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize given the guidance of the prior art. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ.
As such, before the effective filing date of the claimed invention it would have been prima facie obvious for a person of ordinary skill in the art to determine the optimal dose regimen to achieve the best result for a particular patient.
All this will result in the practice of claims 1 and 39 with a reasonable expectation of success.
For claim 31, Cases teaches that the patients have ND-CKD (see page 27, left column, first paragraph under “Vadadustat”).
For claim 32, Cases teaches that the patients have DD-CKD (see page 27, left column, first paragraph under “Vadadustat”).
For claim 116, Cases teaches the administration of 300 mg once daily or 450 mg once daily, both anticipate the instantly claimed range (150-600 mg once daily), thus resulting in the practice of claim 116 with a reasonable expectation of success.
2) Claim(s) 125, 128, 160-161, 164 and 186-187 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cases et. al. (Drugs of the Future (2018) 43:23-33) as applied to claims 1, 31-32, 39 and 116 above, further in view of Pergola (Kidney International (2016) 90:1115-1122, cited by Applicant).
Cases teaches all the limitations of claim 125, except for the level of ferritin and the 150-600 mg dose once daily. However, Cases teaches that under similar circumstances patients were administered 300 mg once daily (see page 27, right column, beginning of third paragraph), and Pergola teaches that the patients have a ferritin level between 284.7 and 264.5 ng/ml (see Table 1 on page 1116), which anticipates the instantly claimed range, thus resulting in the practice of claim 125 with a reasonable expectation of success.
Cases teaches all the limitations of claim 128, except for adjusting the dose of Compound 1 if the patient reaches certain Hb levels. However, Pergola teaches that dose adjustments was permitted per the protocol-specified algorithm and suspended if Hb is>= than 13.0 g/dl (see page 1121, left column, first paragraph).
As such, before the effective filing date of the invention it would have been prima facie obvious for a person of ordinary skill in the art to adjust the dose of compound 1 based on the Hb patient level, thus resulting in the practice of claim 128 with a reasonable expectation of success.
Cases teaches all the limitations of claim 160 except for the patient Hb levels.
However, Pergola teaches that the patients have an Hb level between 9.9 and 10.0 g/dl (see Table 1 on page 1116) which anticipates the instantly claimed range, thus resulting in the practice of claim 160 with a reasonable expectation of success.
Cases teaches all the limitations of claim 161, except for the patient Hb levels.
However, Pergola teaches that the patients have an Hb level between 9.9 and 10.0 g/dl (see Table 1 on page 1116) which anticipates the instantly claimed range.
MPEP 2144.05 states: In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Even a slight overlap in range establishes a prima facie case of obviousness. In re Peterson, 65 USPQ2d 1379, 1382 (Fed. Cir. 2003).
All this will result in the practice of claim 161 with a reasonable expectation of success.
Cases teaches all the limitations of claim 164, except for the patient Hb and ferritin levels.
However, Pergola teaches that the patients have an Hb level between 9.9 and 10.0 g/dl (see Table 1 on page 1116) which anticipates the instantly claimed range, and ferritin levels between 284.7 and 264.5 ng/ml (see Table 1 on page 1116), which anticipates the instantly claimed range, thus resulting in the practice of claim 164 with a reasonable expectation of success.
Cases teaches all the limitations of claim 165, except for the dose of 150-600 mg of Compound 1 once daily and the patient Hb and ferritin levels.
However, Cases also teaches that under similar circumstances patients were administered 300 once mg daily (see page 27, right column, beginning of third paragraph).
Pergola teaches that the patients have an Hb level between 9.9 and 10.0 g/dl (see Table 1 on page 1116) which anticipates the instantly claimed range, and ferritin levels between 284.7 and 264.5 ng/ml (see Table 1 on page 1116), which anticipates the instantly claimed range, thus resulting in the practice of claim 165 with a reasonable expectation of success.
Cases teaches all the limitations of claim 186, except for initial dose of Compound 1
However, Pergola teaches that dose adjustments was permitted per the protocol-specified algorithm and suspended if Hb is>= than 13.0 g/dl (see page 1121, left column, first paragraph).
As such, before the effective filing date of the invention it would have been prima facie obvious for a person of ordinary skill in the art to adjust the dose of compound 1 based on the Hb patient level, thus resulting in the practice of claim 186 with a reasonable expectation of success.
Cases teaches all the limitations of claim 187 (see above 102(a)(1) rejection), except for the increased dose of Compound 1
However, Pergola teaches that dose adjustments was permitted per the protocol-specified algorithm and suspended if Hb is>= than 13.0 g/dl (see page 1121, left column, first paragraph).
As such, before the effective filing date of the invention it would have been prima facie obvious for a person of ordinary skill in the art to adjust the dose of compound 1 based on the Hb patient level.
Further, dose regimen optimization is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize given the guidance of the prior art. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ.
As such, before the effective filing date of the claimed invention it would have been prima facie obvious for a person of ordinary skill in the art to determine the optimal dose regimen to achieve the best result for a particular patient, thus resulting in the practice of claim 187 with a reasonable expectation of success.
Response to Applicant’s arguments related to the above rejection
Applicant's arguments have been fully considered but are not persuasive.
Since a new rejection was issued (see above), only those arguments presented by Applicant that are relevant to the new rejection are being considered.
Examiner’s response:
First, Cases teaches that the treatment can last a minimum of 1 year, which clearly overlap with the instantly claimed range of “for at least 53-260 weeks”.
Second even though Cases does not teach the six to eight weeks prior to administering compound 1, the fact is that Cases teaches a clinical trial wherein the patients were treated with ESA prior to administering compound 1 and they seem to have obtained very good efficacy results (see Case page 27, right column, last paragraph) so there seems to be no unexpected results regarding the timing between the ESA administration and Compound 1 administration.
Conclusion
No claims are allowed.
Applicant's submission of an information disclosure statement under 37 CFR 1.97(c) with the fee set forth in 37 CFR 1.17(p) on 05/10/10 prompted the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 609.04(b). 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 extension fee 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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARCOS L SZNAIDMAN whose telephone number is (571)270-3498. The examiner can normally be reached Flexing M-F 7 AM-7 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L. Clark can be reached on 571 272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARCOS L SZNAIDMAN/
Primary Examiner, Art Unit 1628
January 14, 2026.