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 .
Formal Matters
Claims 1-198 were originally presented on 12/15/2022. The preliminary amendments to the claims filed 8/8/2023 have been received and entered. Claims 3-35, 37, 39-43, 46-62, 64-87, 89-93, 95, 97-114, 116-137, 139-167, 169-191, 195, and 197-198 were cancelled and claim 199 newly added.
Pursuant with the above, claims 1-2, 36, 38, 44-45, 63, 88, 94, 96, 115, 138, 168, 192-194, 196, and 199 are pending and under examination.
Priority
This application is a 35 U.S.C. § 371 National Stage Application of International Application No. PCT/US2021/037781, filed on June 17, 2021, which claims benefit of and priority to U.S. Provisional Patent Application No. 63/041,226, filed June 19, 2020; U.S. Provisional Application No. 63/041,308, filed June 19, 2020; and U.S. Provisional Application No. 63/155,013, filed March 1, 2021.
Information Disclosure Statement
Applicant’s Information Disclosure Statement filed 8/22/2023 has been received and entered into the present application. As reflected by the attached, completed copy of form PTO-1449, the Examiner has considered the cited references to the extent that they comply with the provisions of 37 C.F.R. §1.97, §1.98 and MPEP §609.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(B) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
"The primary purpose of this requirement of definiteness of claim language is to ensure that the scope of the claims is clear so the public is informed of the boundaries of what constitutes infringement of the patent. A secondary purpose is to provide a clear measure of what applicants regard as the invention so that it can be determined whether the claimed invention meets all the criteria for patentability and whether the specification meets the criteria of 35 U.S.C. 112, first paragraph with respect to the claimed invention.", (see MPEP § 2173).
Claims 1-2, 36, 38, 44-45, 63, 88, 94, 96, 115, 138, 168, 192-194, 196, and 199 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In independent claims 1 and 63, it is unclear whether the parenthetical expression “(anemia secondary to or associated with chronic kidney disease)” is a controlling limitation or not given its parenthetical form. Specifically, the claims recite “…wherein the subject has renal anemia (anemia secondary to or associated with chronic kidney disease)…”, which renders the subject population of the claims unclear whether the “renal anemia” is intended to be limited to only “anemia secondary to or associated with chronic kidney disease”.
Claim 199 recites “a drug” which is ambiguous. It is totally unclear which drug is being referred to by “a drug”. Claim 199 depends from claim 1, which recites two different drugs – a “first drug” and a “second drug”. It is unclear if “a drug” recited in claim 199 is intended to refer to one of the drugs recited in claim 1 (and if so, which one) or some other drug entirely.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1, 36, 38, 63, 194, 196, and 199 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2015/073779 A1 (Published May 21, 2015) (Cited by Applicants in IDS filed 8/22/2023).
Independent claim 1 requires administering an effective amount of a first drug that is Compound 1 (Vadadustat) and an effective amount of a second drug that is, inter alia, an iron-containing composition to a subject having renal anemia (anemia secondary to or associated with chronic kidney disease). The first drug is required to be administered at least 1 hour or at least 2 hours before and/or after taking the second drug.
WO ‘779 teaches solid forms comprising the claimed Compound 1, i.e., {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid (Abstract; [0002]; [0007]; [0041]). The compound is used in methods of treating or preventing anemia secondary to or associated with chronic kidney disease comprising administering to a patient having anemia an effective amount of a solid form of Compound (I) ([0007]; [00116]-[00117]). In the therapeutic methods taught therein, e.g., treating anemia secondary to or associated with chronic kidney disease, {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid is administered in combination with another medicament which may be achieved by way of the simultaneous, sequential, or separate dosing of the individual components of the treatment ([00131]). When administered as a component of such a combination therapy, the daily dose of either or both of the components may be reduced as compared to the dose of either component that would normally be given as monotherapy (Id.). Specifically, regarding claims 1, 36, 38, 63, and 199, the invention relates to methods for treating anemia, such as anemia secondary to chronic kidney disease, comprising administering a compound which is {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid to a patient having anemia, wherein the Compound (I) is optionally administered in combination with an iron supplement, such as ferrous sulfate, ferrous gluconate, or ferrous fumarate. In certain such embodiments, the iron supplement is administered at least one hour, at least two hours, at least three hours, at least four hours, or even at least six hours following administration of the compound. The iron supplement is administered orally at a dose of at least about 50 mg of elemental iron ([00132]). Regarding claims 194 and 196, the daily dose of Compound (I) is about 150 mg, about 300 mg, about 450 mg, about 600 mg, or about 750 mg ([00132]).
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 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.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
Claims 1-2, 36, 38, 63, 88, 94, 96, 168, 192-194, 196, and 199 are rejected under 35 U.S.C. 103(a) as being unpatentable over WO 2015/073779 A1 (Published May 21, 2015) and MARTIN ET AL. (Am. J. Nephrol., 2017;45:380–388) (NEWLY CITED) in view of CHAVAN ET AL. (EMBASE/Elvesier, January 1, 2020, Database Accession No. EMB-633697266, Conference Abstract, 2 pages) (Cited by Applicants in IDS filed 8/22/2023).
Independent claim 1 requires administering an effective amount of a first drug that is Compound 1 (Vadadustat) and an effective amount of a second drug that is, inter alia, an iron-containing composition to a subject having renal anemia (anemia secondary to or associated with chronic kidney disease). The first drug is required to be administered at least 1 hour or at least 2 hours before and/or after taking the second drug.
WO ‘779 teaches solid forms comprising the claimed Compound 1, i.e., {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid (Abstract; [0002]; [0007]; [0041]). The compound is used in methods of treating or preventing anemia secondary to or associated with chronic kidney disease comprising administering to a patient having anemia an effective amount of a solid form of Compound (I) ([0007]; [00116]-[00117]). In the therapeutic methods taught therein, e.g., treating anemia secondary to or associated with chronic kidney disease, {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid is administered in combination with another medicament which may be achieved by way of the simultaneous, sequential, or separate dosing of the individual components of the treatment ([00131]). When administered as a component of such a combination therapy, the daily dose of either or both of the components may be reduced as compared to the dose of either component that would normally be given as monotherapy (Id.). Specifically, regarding claims 1, 36, 38, 63, and 199, the invention relates to methods for treating anemia, such as anemia secondary to chronic kidney disease, comprising administering a compound which is {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid to a patient having anemia, wherein the Compound (I) is optionally administered in combination with an iron supplement, such as ferrous sulfate, ferrous gluconate, or ferrous fumarate. In certain such embodiments, the iron supplement is administered at least one hour, at least two hours, at least three hours, at least four hours, or even at least six hours following administration of the compound. The iron supplement is administered orally at a dose of at least about 50 mg of elemental iron ([00132]). Regarding claims 194 and 196, the daily dose of Compound (I) is about 150 mg, about 300 mg, about 450 mg, about 600 mg, or about 750 mg ([00132]).
Regarding claims 192-193, which require that the chronic kidney disease is dialysis-dependent chronic kidney disease (DD-CKD) or nondialysis-dependent chronic kidney disease (NDD-CKD), respectively, MARTIN ET AL. teach that vadadustat (AKB-6548)1 is an oral small molecule HIF-PH inhibitor that is in development for the treatment of anemia in patients with nondialysis-dependent (NDD)-CKD or dialysis-dependent (DD)-CKD (p.381, left column, 3rd full paragraph).
Claims 2, 88, 94, 96, and 168 differ from WO ‘779 in the second drug administered in combination with {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid, i.e., a statin such as rosuvastatin or simvastatin.
CHAVAN ET AL. teach vadadustat [claimed “first drug” Compound 1] is an oral HIF-PHI in late-stage development for the treatment of anemia due to chronic kidney disease (CKD). They teach the prevalence of dyslipidemia in CKD is very high and nearly 50% of patients have been prescribed statins to decrease cholesterol levels. They teach evaluating the drug interaction potential for statins when co-administered with vadadustat wherein healthy adults were administered 600 mg vadadustat daily concomitantly with either rosuvastatin (20 mg), pravastatin (40 mg), atorvastatin (40 mg), or simvastatin (40 mg). They teach that exposure to rosuvastatin, a BCRP and OATP1B1 substrate increased 2- to 3-fold in the presence of vadadustat and for simvastatin (also a BCRP and OATP1B1 substrate) the AUC increased 2-fold and Cmax increased 1.2-fold in the presence of vadadustat. They conclude that increases in exposure to rosuvastatin and simvastatin are possibly due to BCRP inhibition and that these results provide information to aid in the management of concomitant administration of vadadustat with statins. See Abstract.
It would have been obvious to a person of ordinary skill in the art to co-administer a statin and vadadustat to subjects having anemia secondary to or associated with chronic kidney disease such as DD-CKD or NDD-CKD and adjust the amount of the statin as needed depending on whether vadadustat increases or decreases exposure of the statin. One exemplary rationale for the Examiner’s determination of obviousness is that the claimed invention is a combination of prior art elements according to known methods to yield predictable results. In this regard, the prior art teaches Compound 1 (claimed “first drug”/Vadadustat) for the treatment of anemia secondary to or associated with CKD in amounts recited in the instant claims (WO ‘779), e.g., DD-CKD or NDD-CKD (Martin et al.). The prior art suggests that vadadustat will likely be administered to subjects having anemia due to chronic kidney disease (CKD) who are also being administered statins (Chavan et al.). It was known in the art that when vadadustat is co-administered with statins, exposure of the statins is increased (Chavan et al.). Accordingly, the skilled artisan would have recognized that the statin dosage could be predictably adjusted (decreased) when administered to subjects also being administered vadadustat to account for the expected increased exposure of the statin in such subjects. For example, because exposure to rosuvastatin when administered at a dose of 20 mg is increased 2- to 3-fold, decreasing the dose by half (to 10 mg) would be expected to lead to a similar exposure as 20 mg in the absence of vadadustat.
Conclusion
Claims 1-2, 36, 38, 44-45, 63, 88, 94, 96, 115, 138, 168, 192-194, 196, and 199 are rejected.
No claims are allowed.
Applicant is requested to specifically point out the support for any amendments made to the disclosure in response to this Office action, including the claims (M.P.E.P. §§ 714.02 and 2163.06). In doing so, applicant is requested to refer to pages and line (or paragraph) numbers (if available) in the as-filed specification, not the published application. Due to the procedure outlined in M.P.E.P. § 2163.06 for interpreting claims, other art may be applicable under 35 U.S.C. § 102 or 35 U.S.C. § 103(a) once the aforementioned issue(s) is/are addressed.
Applicant is reminded that MPEP §2001.06(b) clearly states that “[t]he individuals covered by 37 C.F.R. 1.56 have a duty to bring to the attention of the examiner, or other Office official involved with the examination of a particular application, information within their knowledge as to other copending United States applications which are "material to patentability" of the application in question." See Armour & Co. v. Swift & Co., 466 F.2d 767, 779, 175 USPQ 70, 79 (7th Cir. 1972). MPEP §2001.06(b) clearly indicates that “if a particular inventor has different applications pending in which similar subject matter but patentably indistinct claims are present that fact must be disclosed to the examiner of each of the involved applications.” See Dayco Prod. Inc. v. Total Containment, Inc., 329 F.3d 1358, 1365-69, 66 USPQ2d 1801, 1806-08 (Fed. Cir. 2003).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES D ANDERSON whose telephone number is (571)272-9038. The examiner can normally be reached on Monday-Friday, 7:30 am - 4:00 pm PST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Lundgren can be reached on 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/James D. Anderson/Primary Examiner, Art Unit 1629
UNITED STATES PATENT AND TRADEMARK OFFICE
500 Dulany Street
Alexandria, VA 22314-5774
Tel. No.: (571) 272-9038
1 Vadadustat is the same “Compound I” recited in the instant claims and “Compound 1” taught in WO ‘779.