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 .
Non-Final Rejection
. The Status of Claims:
Claims 1, 13-31 are pending.
Claims 1, 13-31 are rejected.
DETAILED ACTION
1. Claims 1, 13-31 are under consideration in this Office Action.
Priority
2. It is noted that this application is a 371 of PCT/KR2022/008450 06/15/2022 , which has a foreign priority document, KOREA, REPUBLIC OF KR10-2021-0077709 06/15/2021.
Drawings
3. The drawings field on 12/12/2023 are accepted by the examiner.
IDS
4. The IDS filed on 12/27/23, 9/13/24,11/25/24,12/20/24,1/10/25, 6/4/25 have
been reviewed by the examiner.
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.
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.
Claim 1 is 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 claim 1, the phrase “A pharmaceutical composition for treating or preventing inhibiting a hyperuricemia-related disease of a subject” is recited.
This expression can be confusing because this is a hybrid claim of combining a composition and a method claim. The examiner recommends to separate it into two different claims.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1 and 13-24 are rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for treating a hyperuricemia , does not reasonably provide enablement for preventing a hyperuricemia disease or the intent of preventing such as inhibiting a hyperuricemia. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims. Applicants are not enabled for preventing any of these diseases. The only established prophylactics are vaccines not the 1-(3-cyano-1-isopropyl-indol-5-yl)pyrazol-4-carboxylic acid compound such as present here. In addition, it is presumed that “prevention” or the intent of prevention such as the inbibition of the claimed disease would requires a method of identifying those individuals who will develop the claimed disease before they exhibit symptoms. There is no evidence of record that would guide the skilled clinician to identify those who have the potential of becoming afflicted.
“The factors to be considered [in making an enablement rejection] have been summarized as the quantity of experimentation necessary, the amount of direction or guidance presented, the presence or absence of working examples, the nature of the invention, the state of the prior art, the relative skill of those in that art, the predictability or unpredictability of the art, and the breadth of the claims”, In re Rainer, 146 USPQ 218 (1965); In re Colianni, 195 USPQ 150, Ex parte Formal, 230 USPQ 546. 1) As discussed above, preventing the disease or the intent of preventing such as inhibiting requires identifying those patients who will acquire the disease before the hyperuricemia occurs. This would require extensive and potentially opened ended clinical research on healthy subjects. 2) The passages spanning lines 23-31 on page 11 and from line 21 ton page 13 to line 2 on page 14 mention the diseases Applicant intend to treat. 3) There is no working example of such a preventive procedure in man or animal in the specification. 4) The claims rejected are drawn to clinical preventative medicine for the hyperuricemia and are therefore physiological in nature. 5) The state of the art is that no general procedure is art-recognized for determining which patients generally will become a hyperuricemia before the fact. 6) The artisan using Applicants invention would be a Board Certified physician in the preventative diseases with an MD degree and several years of experience. Despite intensive efforts, pharmaceutical science has been unable to find a way of getting a compound to be effective for the prevention of a hyperuricemia disease generally. Under such circumstances, it is proper for the PTO to require evidence that such an unprecedented feat has actually been accomplished, In re Ferens, 163 USPQ 609. No such evidence has been presented in this case. The failure of skilled scientists to achieve a goal is substantial evidence that achieving such a goal is beyond the skill of practitioners in that art, Genentech vs. Novo Nordisk, 42 USPQ2nd 1001, 1006. This establishes that it is not reasonable to any agent to be able to prevent a hyperuricemia generally. That is, the skill is so low that no compound effective generally against any hyperuricemia disorders has ever been found let alone one that can prevent such conditions. 7) It is well established that “the scope of enablement varies inversely with the degree of unpredictability of the factors involved", and physiological activity is generally considered to be an unpredictable factor. See In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). 8) The claims broadly read on all patients, not just those undergoing therapy for the claimed disease and on the 1-(3-cyano-1-isopropyl-indol-5-yl)pyrazol-4-carboxylic acid compound.
The Examiner suggests deletion of the word “preventing” or “inhibiting” and the phrase "reducing the risk".
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the claims at issue are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1,13-17, 20, 23-24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1,15-17, 20, 23-28 of copending Application No.18/569,568 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because of some difference between the scope of the claimed invention and that of the claims of the copending application in the followings:
The claims 1 and 15 of copending Application No. 18/569,568 describe the followings:
1. 1. (Currently Amended) A pharmaceutical composition for treating or preventing inhibitinga hyperuricemia-related disease ofa subject, comprising 1-(3-cyano-1-isopropyl-indol-5-yl)pyrazol- 4-carboxylic acid or a pharmaceutically acceptable salt thereof, wherein the 1-(3-cyano-1-isopropyl-indol-5-yl)pyrazol-4-carboxylic acid or a pharmaceutically acceptable salt thereof in the pharmaceutical composition is orally administered to the subject at a dosage of 50 to 200 mg/day, wherein the subject has an estimated glomerular filtration rate (eGFR) of less than 90 mL/min/1.73m2.
15. (Currently Amended) A method of treating or preventing-inhibitinga hyperuricemia- related disease in a subject in need thereof, comprising orally administering to the subject a pharmaceutical composition comprising 1-(3-cyano-1-isopropyl-indol-5-yl)pyrazol-4-carboxylic acid or a pharmaceutically acceptable salt thereof at a dosage of 50 to 200 mg/day, wherein the subject has an estimated glomerular filtration rate (eGFR) of less than 90 mL/min/1.73m2.
, whereas the instant claims 1 and 13 do disclose the following composition as shown below:
1. (Currently Amended) A pharmaceutical composition for treating or preventing inhibiting a hyperuricemia-related disease of a subject, comprising 1-(3-cyano-1-isopropyl-indol-5-yl)pyrazol-4-carboxylic acid or a pharmaceutically acceptable salt thereof, wherein the 1-(3-cyano-1-isopropyl-indol-5-yl)pyrazol-4-carboxylic acid or a pharmaceutically acceptable salt thereof in the pharmaceutical composition is orally administered at a dosage of 50 to 200 mg/day,
wherein when the pharmaceutical composition is administered daily for 12 weeks to a hyperuricemia patient group having a blood uric acid concentration of 8 to 12 mg/dL, it is possible to lower the blood uric acid concentration to less than 6.0 mg/dL in 55% or more of the patient group.
13. (Currently Amended) A method of treating or inhibiting a hyperuricemiarelated disease in a subject in need thereof, comprising orally administering to the subject a pharmaceutical composition comprising 1-(3-cyano-l-isopropyl-indol-5-yl)pyrazol-4-carboxylic acid or a pharmaceutically acceptable salt thereof at a dosage of 50 to 200 mg/day, wherein when the pharmaceutical composition is administered daily for 12 weeks to the subject the blood uric acid concentration in the subject is reduced to less than 6.0 mg/dL.
However, the instant claims differ from the co-pending Application No.18/569,568 in that the scope of the claimed invention with respect to the absence of the limitation of a patient having an estimated glomerular filtration rate (eGFR) of less than 90 mL/min/1.73m2 and the additional limitations of the current claims for being administered daily for 12 weeks; a hyperuricemia patient group having a blood uric acid concentration of 8 to 12 mg/dL and lowering the blood uric acid concentration to less than 6.0 mg/dL in 55% or more of the patient group are present unlike the claims of co-pending Application No..
Even so, the specification does disclose that a hyperuricemia/gout patient group has a blood uric acid concentration of 8 to 12 mg/dL (see page 9, lines 19-20) and the drug was administered for 84 days (12 weeks) (see page 18, lines 1 and 3); also, the blood uric acid concentration was adjusted to less than 5.0 mg/dL in 55 % of the patients or less than 6.0 mg/dL in 50 % or more of the patients (see page 21 , lines 2-6).
From these, it seems reasonable that the limitations of a blood uric acid concentration of 8 to 12 mg/dL and administered for 84 days (12 weeks) and the blood uric acid concentration was adjusted less than 6.0 mg/dL in 50% or more of the patients can be incorporated into the claim 1, whereas the removal of the limitation of” an estimated glomerular filtration rate (eGFR) of less than 90 mL/min/1.73m2 from the claim 1 in order to emphasize the particular aspects of the claimed invention.
Moreover, such modification of limitations in the current claims can be anticipated; there is very little difference as to the patentable distinction.
So, it would have been obvious to the skilled artisan to be motivated to add those limitations to the claim and remove some of the limitation from the claim in order to get narrower the scope of the claimed invention. This is because the skilled artisan in the art would expect such a manipulation to be feasible and successful as guidance shown in the application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Rejections - 35 USC § 103
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.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
6. Claims 1, 13-31 are rejected under 35 U.S.C. 103 as being unpatentable over Song et al (US 2012/0184582 Al) in view of Yun et al (WO 2012/138147 A2) and Pillinger et al ( Seminars in Arthritis and Rheumatism 50, 2020, S24-S30).
.
Determination of the scope and content of the prior art
Song et al discloses an oral administration pharmaceutical composition (see page 8 ,a paragraph#0140) comprising 1-(3-cyano-l-isopropyl-indol-5-yl)pyrazole-4-carboxylic acid( compound 1) or a pharmaceutically acceptable salt thereof and a method for treating hyperuriemia, gout, heart failure, cardiovascular disease, hypertension, diabetes, complications of diabetes, kidney disease, inflammation, articular disease and inflammatory bowel disease (see page 1 , a paragraph#0014) by the composition comprises 1-(3-cyano-l-isopropyl-indol-5-yl)pyrazole-4-carboxylic acid( compound 1) as in claims 1, 26 (see page 33, claim 1; page 36, claim 9; page 38, claims 13-15).
Also, it teaches that the incidence rate of gout is 0.5% in a patient group with a blood uric acid level of 7.0 mg/dl or more, and the incidence rate of gout is 5.5% in a patient group with a uric acid level of 9.0 mg/dl or more as in claim 1 (G. Nuki, Medicine, 2006, 34, 417.about.423). Considering the incidence rate as described above, blood uric acid level is found to be an important causative factor for gout (see page 1, a paragraph#0006).
Furthermore, it shows that the compound 1 with 10 mg/kg can reduce a plasma uric acid level in the range of less than 1 mg/dl (Fig. 1 ) as in claims 17-18 (partially) and also the compound 1 with 10 mg/kg can inhibit a plasma uric acid in the range of more than 60% (% inhibition) as in claim 1 (Fig. 2 ).
The current invention, however, differs from the prior art in that the claimed dosage of 50 to 200 mg/day for a period of 12 weeks and measuring the blood uric acid concentration in a subject having a blood uric acid concentration of 8.0 to 12.0 mg/d for treatment of hyperuricemia and measuring the blood uric acid concentration in a subject having a blood uric acid concentration of 8.0 to 12.0 mg/d for treatment of hyperuricemia and a therapeutic agent for suppressing gout flare are unspecified in the prior art.
Yun et al discloses a composition comprising 1-(3-cyano-l-isopropyl-indol-5-yl)pyrazole-4-carboxylic acid for the treatment of diseases associated with xanthine oxidase selected from the group consisting of hyperuricemia, gout, heart failure as in claims 19-20 and 22, cardiovascular disease, hypertension, diabetes, kidney disease as in claim 21 inflammation and articular disease, and inflammatory bowel disease (see page 20 .claim 1 ; page 21, claim 11).
In addition, it describes that the dosage needed for the treatment of an adult is typically from about 1 to 1,000 mg per day, depending on the intensity and frequency of the administration. When administered to an adult via an intramuscular or intravenous route, a total dosage from about 1 to 500 mg per day will be sufficient when separately administered in a single dosage as in claims 13-15 (see page 6 , aparagraph#50).
Also, Pillinger et al teaches that gout is a disease in which the metabolic condition hyperuricemia leads to the formation of monosodium urate crystals, which provoke acute and chronic inflammatory responses through activation of the innate immune system (see abstract )
Acute flares can be treated by using NSAIDS such as celecoxib, naproxen, and etc,(see page and colchicine as in claims 23-24 (see page S25, a left col., the first and third paragraphs).
Ascertainment of the difference between the prior art and the claims
1. The difference between the instant application and the applied Song et al art is that the Song et al does not expressly teach the claimed dosage of 50 to 200 mg/day for a period of 12 weeks and measuring the blood uric acid concentration in a subject having a blood uric acid concentration of 8.0 to 12.0 mg/d for treatment of hyperuricemia and measuring the blood uric acid concentration in the subject being reduced to less than 6.0 mg/dL in two weeks or less than two weeks and a therapeutic agent for suppressing gout flare. The deficiencies of the Song et al are partially cured by the Yun et al and Pillinger et al.
2. The difference between the instant application and the applied Yun et al art is that the Yun et al does not expressly teach the claimed patient group having a blood uric acid concentration of 8 to 12 mg/dL and lowering the blood uric acid concentration to less than 6.0 mg/dL in 55% or more of the patient group and the blood uric acid concentration in the subject being reduced to less than 6.0 mg/dL in two weeks or less than two weeks and measuring the blood uric acid concentration in a subject having a blood uric acid concentration of 8.0 to 12.0 mg/d for treatment of hyperuricemia and a therapeutic agent for suppressing gout flare. The deficiencies of the Yun et al are partially cured by the Song et al and Pillinger et al.
3. The difference between the instant application and the applied Pillinger et al art is that the Pillinger et al does not expressly teach the claimed composition comprising 1-(3-cyano-l-isopropyl-indol-5-yl)pyrazole-4-carboxylic acid with the dosage of 50 to 200 mg/day for a period of 12 weeks and measuring the blood uric acid concentration in a subject having a blood uric acid concentration of 8.0 to 12.0 mg/d for treatment of hyperuricemia and the blood uric acid concentration in the subject being reduced to less than 6.0 mg/dL in two weeks or less than two weeks. The deficiencies of the Pillinger et al are partially cured by the Song et al and Yun et al.
Resolving the level of ordinary skill in the pertinent art.
Regarding the Claims 13-16 with respect to the lack of disclosing the claimed dosage of 50 to 200 mg/day for a period of 12 weeks, the secondary Yun et al does teach generally that the dosage needed for the treatment of an adult is typically from about 1 to 1,000 mg per day or from about 1 to 500 mg per day(see page 6 , a paragraph#50); the claimed dosage of 50 to 200 mg/day is within the dosage range of Yun et al. Thus, the prior art is relevant to the claimed invention.
Furthermore, regarding the lack of teaching the treatment-period of 12 weeks, it depends on various factors such as the prescription of a physician, body weight or age of the patient, specific nature of the disease, severity of the disease. Both of Song and Yun prior art are closely related to each other for treating hyperuricemia by using the same compound.
So, If the skilled artisan in the art had desired to treat a patient having hyperuricemia in the consideration of the body weight and/or the age of the patient, it would have been obvious to the skilled artisan in the art to be motivated to adjust the dosage as well as its treatment period by a routine experimentation to arrive at the claimed treatment-period for 12 weeks. This is within the purview of the skilled artisan in the art to do so.
Regarding the Claim 25 with respect to the lack of disclosing the measurement of the blood uric acid concentration in a subject having a blood uric acid concentration of 8.0 to 12.0 mg/d for treatment of hyperuricemia, Song et al does disclose generally that the incidence rate of gout is 5.5% in a patient group with a uric acid level of 9.0 mg/dl or more. Considering the incidence rate as described above, blood uric acid level is found to be an important causative factor for gout (see page 1, a paragraph#0006). Similarly, a patient with hyperuricemia may have a uric acid level of 9.0 mg/dl or more in the blood. Thus, it would be a reasonable step for the skilled artisan in the art to measure a blood uric acid concentration for the patient with hyperuricemia as a part of the process of treating the patient.
So, If the skilled artisan in the art had desired to treat a patient having hyperuricemia completely, it would have been obvious to the skilled artisan in the art to be motivated to add the procedure for measuring the blood uric acid concentration in a subject having a blood uric acid concentration of 8.0 to 12.0 mg/d as a part of the treatment-plan of hyperuricemia. This is within the purview of the skilled artisan in the art to do so.
Regarding the claims 27-31 with respect to the lack of disclosing the blood uric acid concentration in the subject being reduced to less than 6.0 mg/dL in two weeks or less than two weeks, the prior art are silent about it. However, Song et al does show that the compound 1 with 10 mg/kg can reduce a plasma uric acid level in the range of less than 1 mg/dl (Fig. 1 ) regardless of the effective duration for the treatment.
So, if the skilled artisan in the art had desired to find out the effective duration for the treatment for a patient having hyperuricemia by using 1-(3-cyano-1-isopropyl-indol-5-yl)pyrazole-4- carboxylic acid with an administration dose of 50 to 200 mg/day, it would have been obvious to the skilled artisan in the art to be motivated to do in order arrive at the claimed period. This practice can be within the purview of the skilled artisan in the art to do so.
Considering objective evidence present in the application indicating obviousness or nonobviousness.
Song et al expressly discloses the oral administration pharmaceutical composition (see page 8 ,a paragraph#0140) comprising 1-(3-cyano-l-isopropyl-indol-5-yl)pyrazole-4-carboxylic acid( compound 1) or a pharmaceutically acceptable salt thereof and the method for treating hyperuriemia, gout, heart failure, cardiovascular disease, hypertension, diabetes, complications of diabetes, kidney disease, inflammation, articular disease by using the comprising 1-(3-cyano-l-isopropyl-indol-5-yl)pyrazole-4-carboxylic acid.
Similarly, Yun et al does teach the composition comprising 1-(3-cyano-l-isopropyl-indol-5-yl)pyrazole-4-carboxylic acid with the dosage of from about 1 to 500 mg per day for the treatment of diseases associated with xanthine oxidase selected from the group consisting of hyperuricemia, gout, heart ,cardiovascular disease, hypertension, diabetes, kidney disease , inflammation and articular disease.
Furthermore, Pillinger et al does describe that gout flare associated with the metabolic condition hyperuricemia can be treated by using NSAIDS such as celecoxib, naproxen, and etc,(see page and colchicine (see page S25, a left col., the first and third paragraphs).
Song et al and Yun et al are closely related to the treatment of hyperuricemia by using the same composition containing 1-(3-cyano-l-isopropyl-indol-5-yl)pyrazole-4-carboxylic acid, whereas Pillinger et al teaches the additional therapeutic agent for gout flare.
So, if the skilled artisan in the art had desired to develop the composition for the method of treating hyperuricemia by using the composition containing 1-(3-cyano-l-isopropyl-indol-5-yl)pyrazole-4-carboxylic acid with the specific dosage range for enhancing the overall treatment, it would have been obvious to the skilled artisan in the art before the effective filing date of the claimed invention to be motivated to incorporate the teaching of Yun’s specific dosage range in combination with Pillinger’s additional therapeutic agent into the Song’s et al composition for the method. This is because the skilled artisan in the art would expect such combined composition for the method to be successful and feasible as guidance shown in the prior art.
Conclusion
Claims 1, 13-31 are rejected.
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/TAYLOR V OH/Primary Examiner, Art Unit 1625 3/6/2026