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 7-12 are pending.
Claims 7-12 are rejected.
DETAILED ACTION
1. Claims 7-12 are under consideration in this Office Action.
Priority
2. It is noted that this application is a a 371 of PCT/KR2022/006230 05/02/2022 ,which has foreign priority documents, KOREA, REPUBLIC OF KR10-2021-0062252 05/13/2021 and KOREA, REPUBLIC OF KR10-2021-0110520 08/20/2021 .
Drawings
3. The drawings filed on 10/25/2023 are accepted by the examiner.
IDS
4. The IDS filed on 12/3/25, 5/21/25, 2/20/25, 8/8/24, 1/2/24. &10/25/23 were
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 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 7-12 are rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for treating specific diseases, does not reasonably provide enablement for preventing fibrosis in a subject. 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 the diseases. The only established prophylactics are vaccines not the claimed drug such as present here. In addition, it is presumed that “prevention” of the claimed diseases would require a method of identifying those individuals who will develop the claimed diseases 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 diseases requires identifying those patients who will acquire the disease before psoriasis occurs. This would require extensive and potentially opened ended clinical research on healthy subjects. 2) There is no working example of such a preventive procedure in man or animal in the specification. 3) The claims rejected are drawn to clinical preventative medicine and are therefore physiological in nature. 4) The state of the art is that no general procedure is art-recognized for determining which patients generally will become the patients with a disease or disorder or condition response to an immune system before the fact. 6) The artisan using Applicants invention would be a Board Certified physician in the fibrosis 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 fibrosis in the subject 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 psoriasis generally. That is, the skill is so low that no compound effective generally against the fibrosis 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 diseases.
The Examiner suggests deletion of the word “preventing” or “ prevention” from the claims.
Claim Rejections - 35 USC § 103
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.
5. Claims 7-12 are rejected under 35 U.S.C. 103 as being unpatentable over Song et al (US 2021/0205253 A1), which is equivalent to Song et la (WO 2019/231281 A1) with the publication dated on December 5th , 2019.
.
Applicant claims the followings:
7. (New) A method for preventing or treating fibrosis in a subject in need thereof, comprising administering to the subject 100 mg to 150 mg of a compound represented by the following Chemical Formula 1 or a pharmaceutically acceptable salt thereof twice a day (BID):
PNG
media_image1.png
78
211
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Greyscale
[Chemical Formula 1] CI
8. (New) The method according to claim 7, wherein: the fibrosis is Interstitial lung disease (ILD), Scleroderma, Keloid, Hypertrophic scar, Non-alcoholic Fatty Liver Disease, Primary sclerosing cholangitis (PSC), primary biliary cholangitis (PBC), diabetic retinopathy, Age-related Macular Degeneration (AMD), hypertrophic cardiomyopathy, myocardial infarction, Muscular Dystrophy, Diabetic kidney disease, focal segmental glomerulosclerosis (FSGS), or Inflammatory bowel disease (IBD).
9. (New) The method according to claim 8, wherein: the Interstitial lung disease (ILD) is idiopathic pulmonary fibrosis (IPF), systemic sclerosis associated interstitial lung disease (SSc-ILD), or chronic fibrosing interstitial lung diseases with a progressive phenotype (PF-ILD).
10. (New) The method according to claim 1, wherein: the pharmaceutically acceptable salt is hydrochloride.
11. (New) The method according to claim 1, wherein: the pharmaceutical composition further comprises other active component used for the prevention or treatment of fibrosis.
12. (New) The method according to claim 11, wherein: the other active component used for the prevention or treatment of fibrosis is Pirfenidone or Nintedanib.
20
Determination of the scope and content of the prior art
Song et al discloses a pharmaceutical composition for treating pulmonary fibrosis, the composition comprising, as active ingredients: stearic acid, a salt of the stearic acid or a prodrug of the stearic acid; and a pulmonary fibrosis inhibitor. According to the present invention, a more excellent treatment effect may be induced by the co-administration of a conventional pulmonary fibrosis inhibitor and stearic acid, and by using stearic acid, the sensitivity to the conventional pulmonary fibrosis (see abstract).
Furthermore, Song et al teaches the method of treating pulmonary fibrosis such as idiopathic pulmonary fibrosis (IPF) as in claims 8-9 and 11 (see page 2, a paragraph#0016), using a pulmonary fibrosis inhibitor and other active ingredients in the followings:
6. A method for treating pulmonary fibrosis, comprising: administering to a subject in need thereof an effective amount of (i) stearic acid, a salt of the stearic acid or a prodrug of the stearic acid; and (ii) a pulmonary fibrosis inhibitor.
7. The method of claim 6, wherein the pulmonary fibrosis inhibitor is selected from the group consisting of pirfenidone, nintedanib, as in claim 10 trimethoprim/sulfamethoxazole (co-trimoxazole), a recombinant human pentraxin-2 protein (PRM-151), romilkimab (SAR156597), pamrevlumab, BG00011, treprostinil, TD139, CC-90001, 2-((2-ethyl-6-(4-(2-(3-hydroxyazetidin-1-yl)-2-oxoethyl)piperazin-1-yl)-8-methylimidazo[1,2-a]pyridin-3-yl)(methyl)amino)-4-(4-fluorophenyl)thiazole-5-carbonitrile)(GLPG1690), losartan, tetrathiomolybdate, lebrikizumab, zileuton, nandrolone decanoate, sirolimus, everolimus, vismodegib, fresolimumab, omipalisib (GSK2126458), (3S)-3-[3-(3,5-dimethyl-1H-pyrazol-1-yl)phenyl]-4-{(3S)-3-[2-(5,6,7,8-tetrahydro-1,8-naphthyridin-2-yl)ethyl]-1-pyrrolidinyl}butanoic acid (GSK3008348), rituximab, octreotide, 2-[3-[4-(1H-indazol-5-ylamino)-2-quinazolinyl]phenoxy]-N-(1-methylethyl)-acetamide (KD025), tipelukast (MN-001), BBT-877, OLX201, DWN12088, and a salt thereof as in claim 7 (see page 12 , claims 6-7)
In addition, as used herein the term salt or “pharmaceutically acceptable salt” refers to a formation of a compound which does not induce serious irritation in the organism to which the compound is administered and does not impair the biological activity and physical properties of the compound. The pharmaceutical salt may be obtained by reacting the compound of the present invention with an inorganic acid such as hydrochloric acid as in claim 10 (see page 5, a paragraph#0084)
Also, the term “pharmaceutically effective amount” refers to an amount of an active ingredient capable of exerting a pharmaceutically meaningful effect. A pharmaceutically effective amount of the active ingredient for a single dose may be prescribed in various ways depending on factors, such as formulation method, administration method, age, body weight, sex or disease condition of the patient, diet, administration time, administration interval, administration route, excretion rate and response sensitivity. For example, a pharmaceutically effective amount of stearic acid for a single dose may range from 0.0001 to 200 mg/kg, 0.001 to 100 mg/kg, or 0.02 to 10 mg/kg, but is not limited thereto, previously license drugs pirfenidone and
nintedanib or other publicly-known pulmonary fibrosis inhibitors may be used together in an effective amount previously licensed or known in the art, and it is obvious to those skilled in the art that the dose may be adjusted more or less than when administered alone, depending on the use examples and proportions disclosed in the present invention. (see page 5, a paragraph#0087)
The current invention, however, differs from the prior art in that administering to the subject 100 mg to 150 mg of the claimed compound of DWN12088 is unspecified in the prior art.
Ascertainment of the difference between the prior art and the claims
The difference between the current application and the applied Song et al art is that the Song et al does not expressly teach administering to the subject 100 mg to 150 mg of the claimed compound.
Resolving the level of ordinary skill in the pertinent art.
Regarding the Claim 7 , with respect to the lack of disclosing the specific dosage range of the DWN12088 from 100 mg to 150 mg, the prior art is silent about it. However, Song does give indirectly guidance at least that a pharmaceutically effective amount of stearic acid for a single dose may range from 0.0001 to 200 mg/kg; also, drugs pirfenidone and nintedanib and other publicly-known pulmonary fibrosis inhibitors may be used together in an effective amount previously licensed or known in the art, and it is obvious to those skilled in the art that the dose may be adjusted more or less than when administered alone, depending on the use examples and proportions. (see page 5, a paragraph#0087). From these teachings, it would have been obvious to the skilled artisan in the art to be motivated to arrive at the claimed dosage range by a routine experimentation on Song’s DWN12088 compound depending on the use for the subject. Therefore, the prior art is relevant to the claimed invention.
Considering objective evidence present in the application indicating obviousness or nonobviousness.
Song et al does teach the method of treating pulmonary fibrosis such as idiopathic pulmonary fibrosis (IPF) (see page 2, a paragraph#0016), using DWN12088 as a pulmonary fibrosis inhibitor and drugs like pirfenidone and nintedanib.
Although Song et al does not give the teaching of administering to the subject 100 mg to 150 mg of the claimed compound, Song et al does describe a generic guidance indirectly that drugs pirfenidone and nintedanib and other publicly-known pulmonary fibrosis inhibitors may be used together in an effective amount previously licensed or known in the art, and it is obvious to those skilled in the art that the dose may be adjusted more or less than when administered alone, depending on the use examples and proportions. (see page 5, a paragraph#0087). From these teachings, 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 adjust the dosage range of Song‘s DWN12088 compound by a routine experimentation depending on the use for the subject in order to arrive at the claimed dosage range. This is because the skilled artisan in the art would expect such adjustment on the dosage of the prior art compound to be within the purview of the skilled artisan in the art.
Conclusion
Claims 7-12 are rejected.
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/TAYLOR V OH/Primary Examiner, Art Unit 1625 1/06/2026