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 .
Final Rejection
The Status of Claims:
Claims 1, 3-22, and 24-30 are pending.
Claims 1, 3-22, and 24-30 are rejected.
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.
IDS
1. The IDS filed on 01/22/2026 are reviewed by the examiner.
Claim Objections
The objection of Claims 24-30 is withdrawn.
Claim Rejections - 35 USC § 112
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The rejection of Claim 23 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn due to the cancelation of the claim .
Claim Rejections - 35 USC § 103
Applicants’ argument filed 5/27/26 have been fully considered, however, in view of
the revised claims and finding a new prior art based on the IDS and some of them
are persuasive, while others are not persuasive.
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.
5.. The rejection of Claims 1-22 under 35 U.S.C. 103 as being unpatentable oJain et al (WO 2023/248193 A1) in view of Kannan et al (WO 2022/238745)
has been changed to the rejection of Claims 1, 3-22, and 24-30 under 35 U.S.C. 103 as being unpatentable over Jain et al (WO 2024/028744 A1) in view of Kannan et al (WO 2022/238745) and Pov (Hematopoietic Acute Radiation Syndrome (Bone marrow syndrome, Aplastic Anemia): Molecular Mechanisms of RadiationToxicity40th COSPAR Scientific Assembly. Held 2-10 August 2014, in Moscow, Russia, Abstract id F5.5-0025-14).
However, in view of the revised claims and filing the IDS and finding a new prior art , another 103 rejection seems necessary in the followings:
Claim(s) 1, 3-22, and 24-30 are rejected under 35 U.S.C. 103 as being unpatentable over Jain et al (WO 2024/028744 A1) in view of Kannan et al (WO 2022/238745) and Pov (Hematopoietic Acute Radiation Syndrome (Bone marrow syndrome, Aplastic Anemia): Molecular Mechanisms of RadiationToxicity, 40th COSPAR Scientific Assembly. Held 2-10 August 2014, in Moscow, Russia, Abstract id F5.5-0025-14).
Applicant claims the followings:
1. (Original) A parenteral pharmaceutical composition comprising desidustat:OH
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Desidustat or a pharmaceutically acceptable salt thereof, wherein the desidustat is present at a concentration of 1 mg/mL to 125 mg/mL.
3. (Currently Amended) The composition of claim [[2]] 1, wherein the concentration of the desidustat is 15 mg/mL to 35 mg/mL.
4. (Currently Amended) The composition of claim [[2]] 1, wherein the concentration of the desidustat is 30 mg/mL to 50 mg/mL.
5. (Currently Amended) The composition of claim [[2]] 1, wherein the concentration of the desidustat is 40 mg/mL to 60 mg/mL.
6. (Currently Amended) The composition of claim [[2]] 1, wherein the concentration of the desidustat is 90 mg/mL to 110 mg/mL.
7. (Currently Amended) The composition of claim [[2]] 1, wherein the concentration of the desidustat is 25 mg/mL.
8. (Currently Amended) The composition of claim [[2]] L wherein the concentration of the desidustat is 40 mg/mL.
9. (Currently Amended) The composition of claim [[2]] L wherein the concentration of the desidustat is 50 mg/mL.
10. (Currently Amended) The composition of claim [[2]] 1 wherein the concentration of the desidustat is 90 mg/mL.
11. (Currently Amended) The composition of claim [[2]] 1, further comprising an isotonic agent/cosolvent.
12. (Original) The composition of claim 11, wherein the isotonic agent/cosolvent is selected from glycerine, sodium chloride, and a mixture thereof.
13. (Original) The composition of claim 12, wherein the isotonic agent/cosolvent is glycerine.
14. (Original) The composition of claim 13, wherein the isotonic agent/cosolvent is present at a concentration of 1% to 1.5% (w/v).
15. (Original) The composition of claim 14, wherein the concentration of the isotonic agent/cosolvent is 1.25% (w/v).
16. (Currently Amended) The composition of claim [[2]] 1 further comprising an alkalizing agent.
17. (Original) The composition of claim 16, wherein the alkalizing agent is selected from sodium hydroxide, meglumine, tromethamine, and a mixture thereof.
18. (Original) The composition of claim 16, wherein the alkalizing agent is sodium hydroxide.
19. (Original) The composition of claim 18, wherein isotonic alkalizing agent is present at a concentration of 0.5% to 1% (w/v).
20. (Original) The composition of claim 19, wherein the concentration of the isotonic alkalizing agent is 0.65% (w/v).
21. (Currently Amended) The composition of claim [[2]] 1 further comprising glycerine and sodium hydroxide.
22. (Currently Amended) The composition of claim 21, wherein the isotonic agent/cosolventglycerineis present at a concentration of 1.25% (w/v) and the sodium hydroxide is present at a concentration of 0.65% (w/v).
24. (Currently Amended) A method of treating radiation induced toxicity in a subject in need thereof, the method comprising administering to the subject a therapeutically effective amount of the pharmaceutical composition of claim 1 desidustat:
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OH Desidustat or a pharmaceutically acceptable salt thereof.
25. (Original) The method of claim 24, wherein the radiation induced toxicity is acute radiation syndrome.
26. (Original) The method of claim 25, wherein the acute radiation syndrome is hematopoietic acute radiation syndrome (H-ARS).
27. (Original) The method of claim 26, wherein 1 mg to 25 mg of the desidustat or a pharmaceutically acceptable salt thereof is administered to the subject.
28. (Original) The method of claim 27, wherein the method increases hemoglobin and/or red blood cell (RBC) count relative to baseline of a subject by at least 5% (w/w), 10% (w/w), or 15% (w/w).
29. (Original) The method of claim 24, further comprising administering an additional therapeutic agent to the subject.
30. (Original) The method of claim 29, wherein the additional therapeutic agent is selected from Neupogen (filgrastim), Neulasta (pegfilgrastim), Leukine (sargramostim), and Nplate (romiplostim).
Determination of the scope and content of the prior art
Jain (WO2024) describes a pharmaceutical composition containing the compound of formula (Ia) as given below:
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and its pharmaceutically acceptable salts is effective in the treatment of aplastic anemia when combine with a suitable TPO receptor agonist improve two lineage of hematopoietic precursor cells for the benefit of patients (see page 3, lines 4-8)..
The pharmaceutical acceptable salts of the compound of formula (Ia) may be selected from suitable inorganic metal salts or organic amines salts (see page 5, lines 17-18).
Organic amines salt is selected from methylamine, dimethylamine, ethylamine, diethyl amine, npropyl amine, isopropyl amine, diisopropyl amine, N-methyl isopropyl amine, n-butyl amine, tbutyl amine, 2-butamine, 1,2-ethane diamine, N-methylglucamine, N,N,N-trimethyl ethanolamine hydroxide (choline), tromethamine, as in claims 16-17, cyclohexylamine,.. (see page 6, lines 1-4).
The pharmaceutical composition of combination of compound of formula (Ia) or its pharmaceutically acceptable salts and Romiplostim can be administered via parenteral rout.
The parenteral formulation of compound of formula (la) or its pharmaceutically acceptable salts comprising one or more pharmaceutically acceptable excipients for use in treating Aplastic anemia (AA). The compound of formula (Ia) or its pharmaceutically acceptable salts, for parenteral administration to a subject at a dose in the range of 1 mg to 50 mg.(see page 16, lines 12-19 & 25-26).
Furthermore, the stabilizing agent is selected from sucrose, trehalose, mannose, maltose, lactose, glucose, raffinose, cellobiose, gentiobiose, isomaltose, arabinose, glucosamine, fructose, mannitol, sorbitol, glycine, arginine HCL, poly-hydroxy compounds, including polysaccharides such as dextran, starch, hydroxyethyl starch, cyclodextrins, N-methylpyrollidene, cellulose and hyaluronic acid, sodium chloride as in claims 11- 12 (see page 17 , lines 20-24).
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(see page 15, Table 1)
.The current invention, however, differs from the prior art in that the claimed Hematopoietic Acute Radiation Syndrome treatment and the concentration ranges of desidustat, the concentration of isotonic agent/cosolvent , the use of glycerine and sodium hydroxide and the concentration of sodium hydroxide and the method for increasing hemoglobin and/or red blood cell (RBC) count relative to baseline of a subject by at least 5% (w/w) are not exemplified in the prior art .
Kannan et al teaches a topical pharmaceutical composition comprising
compound of formula (Ia) or its pharmaceutically acceptable salts and one or more suitable pharmaceutically acceptable excipients(see page 3, lines 9-11)
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(see page 4 , line 20)
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as in claims 11-13 and 21 (see page 15, table 1)
Generally, a topical solution composition comprising compound of formula (Ia) in therapeutically effective amount selected from 0.01 %w/w to 10.00 % w/w; a topical solution of compound of formula (Ia) further comprising alkalizing agent of about 0.01 to 10.00 %w/w as in claims 19-20; solubilizing agents of about 0.10 to 30.00 %w/w and purified water to adjust the total volume accordingly (see page 6 , line 28 to page 7 , line 2).
Furthermore, Pov teaches that HematopoieticAcute Radiation Syndrome (or Bone marrow syndrome, or Radiation-Acquired Aplastic Anemia) is the acute toxic syndrome which usually occurs with a dose of irradiation between 0.7 and 10 Gy (70- 1000 rads), depending on the species irradiated. .The etiology of bone morrow
damage from high-level radiation exposure results depends on the radiosensitivity of certain bone marrow cell lines (see page 1 , lines 6-.)
Aplastic Anemia is a chronic, often autoimmune condition where the bone marrow stops producing new blood cells. H-ARS (Bone Marrow Syndrome) is the acute, life-threatening clinical illness that happens immediately after massive, whole-body radiation exposure.
Ascertainment of the difference between the prior art and the claims
The difference between the current application and the applied Jain et al et al art is that the applied Jain et al art does not expressly teach the claimed Hematopoietic Acute Radiation Syndrome treatment and the concentration ranges of desidustat, the concentration of isotonic agent/cosolvent , the use of glycerine and sodium hydroxide and the concentration of sodium hydroxide and the method for increasing hemoglobin and/or red blood cell (RBC) count relative to baseline of a subject by at least 5% (w/w).The deficiencies of Jain et al are cured partly by Kannan et al and Pov.
The difference between the current application and the applied Kannan et al art is that the applied Kannan et al art does not expressly teach the claimed
Hematopoietic Acute Radiation Syndrome treatment and the concentration ranges of desidustat, the concentration of isotonic agent/cosolvent and the method for increasing hemoglobin and/or red blood cell (RBC) count relative to baseline of a subject by at least 5% (w/w).The deficiencies of Jain et al are cured partly by Kannan et al and Pov. .The deficiencies of Kannan et al are cured by Jain et al and Pov.
The difference between the current application and the applied Pov art is that the applied Pov art does not expressly teach the claimed pharmaceutical composition containing and the concentration ranges of desidustat, the concentration of isotonic agent/cosolvent , the use of glycerine and sodium hydroxide and the concentration of sodium hydroxide and the method for increasing hemoglobin and/or red blood cell (RBC) count relative to baseline of a subject by at least 5% (w/w).The deficiencies of are cured partly by Jain et al and Kannan et al.
Resolving the level of ordinary skill in the pertinent art.
,
Regarding the claims 1-10, the lack of a teaching of the concentration ranges of desidustat, Jain et al does show at least that the concentration of desidustat can be 5 mg/ml or 25mg/ml according to the table (see page 15, table); furthermore, Jain et al does provide for parenteral administration to a subject at a dose in the range of 1 mg to 50 mg.(see page 16, lines 12-19 & 25-26).
So, if the skilled artisan in the art had desired to form the various concentration ranges of desidustat in the parenteral composition it would have been obvious to the skilled artisan in the art to be motivate to form such a pharmaceutical composition depending on the need of the patient. This is because the skilled artisan in the art would expect such a manipulation to be within the purview of the skilled artisan in the art.
Regarding the claims 14-15, 19-20 and 22, the use of glycerine and sodium hydroxide and the concentration of each of sodium hydroxide and glycerine , Kannan et al does teach generally that the use of glycerine as a solubilizing agent of about 0.01 to 10.00 %w/w , and the use of sodium hydroxide as an alkalizing agent of about 0.10 to 30.00 %w/w for the solution mixture containing the compound of formula (Ia) (see page 6 , line 28 to page 7, line 2). Both of the claimed concentrations are within the ranges disclosed by the Kannan et al prior art . So, it would have been obvious to the skilled artisan in the art to be motivated to control and select the optimum range of each of each of the concentration of sodium hydroxide and glycerine by a routine experimentation in the absence of an unexpected result.
Regarding the claim 28, the lack of teaching the method for increasing hemoglobin and/or red blood cell (RBC) count relative to baseline of a subject by at least 5% (w/w), the priorart are silent about it. However, such an effect is an inherent and predictable consequence of administering Desidustat for the treatment of aplastic anemia or H-ARS, conditions characterized by impaired erythropoiesis. A person skilled in the art would reasonably expect improvement in hematological parameters, including RBC count, upon treatment with a known erythropoiesis-stimulating agent such as Desidustat. Accordingly, the alleged increase in RBC
count represents a routine and inevitable outcome of the known therapeutic use disclosed in the Jain et al
Considering objective evidence present in the application indicating obviou
sness or nonobviousness.
Jain et al expressly) discloses the pharmaceutical composition comprising a compound of formula (Ia) or its pharmaceutically acceptable salts optionally with one or more pharmaceutically acceptable excipients wherein the compound of formula (Ia) is shown below:
,which is effective in the treatment of aplastic anemia when combine with a suitable TPO receptor agonist improve two lineage of hematopoietic precursor cells for the benefit of patients. Furthermore, Jain et al does point out that the compound of formula (Ia) or its pharmaceutically acceptable salt is administered to a subject by the parenteral route of administration, which implies that the formulation of a parenteral pharmaceutical composition comprising a compound of formula (Ia) or its pharmaceutically acceptable salts in terms of mg/ml. Similarly, Kannan et al does teach that the topical pharmaceutical composition comprising the compound of formula (Ia) or its pharmaceutically acceptable salts and one or more suitable pharmaceutically acceptable excipients, such as glycerine as a solubilizing agent and sodium hydroxide as an alkalizing agent (see page 6 , line 28 to page 7 , line 2).
Although the secondary prior art Kannan et al does not teach that the parenteral pharmaceutical composition comprises the compound of formula (Ia), the primary Jain et al prior art does mention the pharmaceutical composition comprising the compound of formula (Ia) can be used for the parenteral route.
Also, Pov does describe that Aplastic Anemia can be related to the H-ARS (Bone Marrow Syndrome) since Aplastic Anemia is a chronic, often autoimmune condition where the bone marrow stops producing new blood cells.
Moreover, the patentability of apparatus or composition claims depends on the claimed structure, not on the use or purpose of that structure." Catalina Mktg. Int'l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 809 (Fed. Cir. 2002). Thus, "recitation of a new intended use for an old product does not make a claim to that old product patentable." In re Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1977).
Jain et al and Kannan et al are commonly related to each other with respect to the pharmaceutical composition containing the compound of formula (Ia) or desidustat regardless of their intended use. Also, Kannan et al does give a guidance generally that glycerine is used as a solubilizing agent , whereas sodium hydroxide is applied as an alkalizing agent for the solution mixture.
So, if the skilled artisan in the art had desired to treat H-ARS as similar to Aplastic Anemia by using a parenteral pharmaceutical composition containing the compound of formula (Ia) or desidustat, it would have been obvious to the skilled artisan in the art to be motivated to incorporate the teaching of Kannan’s et al glycerine as the solubilizing agent and sodium hydroxide as the alkalizing agent in combination of Pov’s teaching into the Jain et al method in order to maximize the effect of the compound of formula (Ia) or desidustat delivery. This is because the skilled artisan in the art would expect such combined prior art to be successful and feasible as guidance shown in the art.
Applicants argue the following issues:
Applicant submits Jain does not teach the features of claim 1 or the claims dependent therefrom in the manner described by the Office. In particular and contrary to the Office's assertions, Jain does not teach parenteral formulations of desidustat. Although the Office has highlighted an instance of the term "parenteral" within Jain, Applicant notes that this recitation is part of a larger list of modes of administration. Upon review of application as a whole, Jain shows no preference for such a modality. Rather this formulation highlighted by Office is a suspension, which is not appropriate for parenteral formulation. Instead, the composition is formulated for oral administration, comprising excipients, e.g., cherry flavor, that are not suitable for use in a parenteral formulation. Flavoring agents are not used in parenteral formulations.
Similarly, the Office refers to Jain's inclusion of both tromethamine and sodium chloride to further support the assertion that Jain teaches paternal formulations. However, each of tromethamine and sodium chloride are members of extensive lists reciting metal salts. Applicant submits the Office has participated in impermissible hindsight reconstruction of the prior art using
Applicant's disclosure as a road map for picking and choosing from multiple lists of salts without considering the disclosure as a whole. None of the formulations described by Jain comprise either of these excipients. Furthermore, the formulation described in the Office Action at page 7 does not comprise either of these excipients.
Additionally, Applicant submits that within the formulations described in the specification, tromethamine is used as alkalizing agent, and sodium chloride is used as Co-solvent/Isotonic agent. In contrast, in Jain et al the tromethamine was used as metal salt, and the sodium chloride was used as a diluent. Furthermore, while preparing a salt of any compound, a person skilled in the art would be aware that salt will form an ionic bond with the compound while excipient does not form any type of bond with the compound. Thus, due to ionic bond formation, there is always an electrostatic attraction when a salt of an Active Pharmaceutical Ingredient (API) is formed. Further, during formation of a salt, the concentration of salt used is typically different when used as an excipient. Accordingly, Applicant submits that there was no motivation for a person skilled in the art to use salts as alkalizing agent and as a diluent as Co-solvent/Isotonic agent.
Additionally, contrary to the Office's characterization, Jain does not teach the
concentration of desidustat as recited in previously pending claim 2 (now incorporated into amended claim 1). While Jain et al. mentions that an effective amount of the compound of formula (Ia) or its pharmaceutically acceptable salts may be administered via a parenteral route (see page 13, lines 26-28), Jain et al. fails to disclose a parenteral composition comprising desidustat at concentrations of either 5 mg/mL or 25 mg/mL, or the dose range of 1 mg to 150 mg. A mere statement of a potential route of administration does not equate to a teaching or suggestion of a composition specifically formulated for parenteral use. Parenteral compositions are subject to distinct and stringent formulation requirements, including sterility, isotonicity, pH control, selection and concentration of excipients that differ fundamentally from oral or other dosage forms. Applicant submits that Jain et al. provides no disclosure or guidance regarding excipient selection, formulation parameters, or composition characteristics required to successfully and safely formulate desidustat for parenteral administration.
Furthermore, Jain et al. fails to correlate the disclosed dosage amounts or selected concentrations with a parenteral formulation, nor does it provide guidance on how such concentrations may be achieved safely and effectively in a parenteral dosage form. Applicant submits the conversion of dose ranges or isolated concentration examples into a parenteral formulation with defined concentration ranges is not a routine or automatic step. Kannan
The Office attempts to address the deficiencies of Jain by citing Kannan, alleging "Kannan et al teaches a topical pharmaceutical composition comprising compound of formula (la) or its pharmaceutically acceptable salts and one or more suitable pharmaceutically acceptable excipients." See Office Action page 7. As discussed above, the present claims refer to a parenteral formulation. As the Office will appreciate, the considerations for preparing a parenteral formulation differ significantly from those for developing a topical formulation. The Office has merely pointed to a different formulation of desidustat described in Kannan without showing any equivalency with those described in the instant application. Applicant submits the Office has failed to articulate why a person of ordinary skill in the art would be motived to prepare a parenteral formulation by using knowledge of topical solution of Kannan.
Furthermore, with regard to claims 14-15, 19-20, and 22 the Office alleges (i) that Kannan et al. discloses the use of glycerine as a solubilizing agent in an amount of 0.01-10.0% w/w and sodium hydroxide as an alkalizing agent in an amount of 0.10-30.0% w/w for compositions containing the compound of formula (Ia), (ii) the claimed concentrations fall within these disclosed ranges, and (iii) the selection and adjustment of glycerine and sodium hydroxide concentrations would have been obvious to a person skilled in the art as a matter of routine optimization in the absence of any unexpected technical effect.
Applicant respectfully disagrees with the Examiner's assertion that the claimed use and concentrations of glycerine and sodium hydroxide would have been obvious in view of Kannan et al.
Kannan et al. broadly discloses the use of glycerine as a solubilizing agent in an amount of about 0.01-10.0% w/w and sodium hydroxide as an alkalizing agent in an amount of about 0.10-30.0% w/w for a topical solution containing the compound of formula (Ia). However, this disclosure is limited to topical formulations and does not teach or suggest the use, selection, or optimization of glycerine and sodium hydroxide in the context of the claimed (amended claim 1) parenteral formulation.
Although the claimed concentrations of excipients may numerically fall within the broad ranges disclosed in Kannan et al., mere overlap of ranges does not render the claimed invention
obvious. Kannan et al. provides no teaching, suggestion, or motivation to select the specific claimed concentrations, nor does it disclose any formulation rationale applicable beyond topical use. In the absence of such guidance, Applicant submits that the Office is relying upon impermissible hindsight reconstruction of the prior art using Applicants application as a road map to combine elements in order to arrive at the claimed invention. Accordingly, Applicant submits that the selection and controlled use of glycerine and sodium hydroxide at the claimed concentrations cannot be considered a matter of routine experimentation, and the cited prior art fails to render claims 14-15, 19-20, and 22 obvious.
The Office has not established aprimafacie case of obviousness based on the combined teachings of Jain and Kannan
Applicant submits that to support a rejection under 35 U.S.C. § 103, the Office is
required to "provide a reasoned explanation as to why the invention as claimed would have been obvious to a person of ordinary skill in the art at the relevant time." MPEP § 2143. In order to make an obviousness rejection that relies on a combination of alleged teachings to arrive at a rejected claim, the Office must articulate,
(1) a finding that there was some teaching, suggestion, or motivation, either in the references themselves or in the knowledge generally available to one of ordinary skill in the art, to modify the reference or to combine reference teachings; (2) a finding that there was reasonable expectation of success; and (3) whatever additional findings based on the Graham factual inquiries may be necessary, in view of the facts of the case under
consideration, to explain a conclusion of obviousness.
MPEP § 2143(G). Additionally, "'rejections on obviousness cannot be sustained by mere conclusory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.'" KSR Int'l Co. v. Teleflex Inc, 550 U.S. 398, 418, 82 USPQ2d at 1396 (quoting In re Kahn, 441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006)).
Applicant submits the Office has failed to make a primafacie case of obviousness at least because the Office has not articulated any of the findings required under the relevant standard, i.e., the factual inquiry under the Graham factors as reaffirmed in KSR. See, e.g., MPEP § 2141(I), (II), and (III). Accordingly, without having explained why or how a person of ordinary skill would have been motivated or guided to combine the cited references to arrive at the instant claims, the Office has not established a primafacie case of obviousness.
As outlined above, each of the cited references on their own fail to disclose the entirety of limitations of the instant claims. The Office has attempted to overcome these deficiencies by combining the alleged teachings Jain and Kannan. Even if each reference teaches some of the limitations of the instant claims and could hypothetically be combined and modified to account for all limitations of the instant claims, which Applicant does not concede, Applicant submits the Office has failed to provide the appropriate rationale for such combinations and modifications.
Instead, the Office has merely stated that a formulation comprising desidustat for
parenteral administration as recited in the instant claims is obvious because "the skilled artisan in the art would expect such combined prior art to be successful and feasible as guidance shown the skilled artisan in the art." See Office Action at pages 13. In other words, the Office alleges that the claimed combination is obvious and would be successful because a teaching of each limitation of the instant claims allegedly exists in separate references for different use than as described in the claims as amended.
While Jain et al. expressly discloses a pharmaceutical composition comprising a compound of formula (Ia) or its pharmaceutically acceptable salts, optionally with pharmaceutically acceptable excipients (see page 14, lines 1-2; page 43, claim 29), Jain et al. does not disclose or exemplify a parenteral pharmaceutical composition. The mere disclosure that the compound of formula (Ia) or its pharmaceutically acceptable salts may be administered via a parenteral route does not constitute a teaching or suggestion of a formulation specifically designed or suitable for parenteral administration.
Furthermore, Kannan et al. discloses only topical pharmaceutical compositions comprising the compound of formula (Ia) or its pharmaceutically acceptable salts with excipients such as glycerine as a solubilizing agent and sodium hydroxide as an alkalizing agent (see page 6, line 28 to page 7, line 2). The teachings of Kannan et al. are limited to topical formulations and do not suggest that such excipients, or their concentrations, are suitable or safe for parenteral administration where glycerine used as isotonic agent and sodium hydroxide as an alkalizing agent.
In order to establish a primafacie case of obviousness, the Office must provide such "objective reason[s]" for the above numerous combinations/modifications all within the framework of the Graham factors. Applicant submits the Office's proposed combination of Jain et al. and Kannan et al. has not done so and has instead relied on hindsight using Applicants
Applicants’ arguments have been noted. However, as indicated in the above, in view of the revised claims and filing the IDS and finding a new prior art , another 103 rejection seems necessary. Because of this reason, the examiner will not respond applicant’s current arguments at this time. But the examiner will respond to applicant’s current arguments in the next communication properly.
Conclusion
Claims 1, 3-22, and 24-30 are rejected.
Applicant's submission of an information disclosure statement under 37 CFR 1.97(c) with the timing fee set forth in 37 CFR 1.17(p) on 5/27/26 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 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.
Applicant's amendment necessitated the new 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 TAYLOR V OH whose telephone number is (571)272-0689. The examiner can normally be reached 8:00-5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached at 571-272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TAYLOR V OH/Primary Examiner, Art Unit 1625 6/15/2026
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