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 .
Priority
Acknowledgment is made of applicant’s claim for priority. The certified copy has been filed in parent Application No. 63/201,704, filed on 05/10/2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/11/2024 is being considered by the examiner.
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.
Claims 12-18, 20-29, 31 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.
The term “about” in claims 12-18, 20-29, 31 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The specification defines about as "As used herein and unless otherwise specified, the terms "about" and "approximately," when used in connection with a numeric value or a range of values which is provided to characterize a particular solid form, e.g., a specific temperature or temperature range, such as, e.g., that describing a DSC or TGA thermal event, including, e.g., melting, dehydration, desolvation or glass transition events; a mass change, such as, e.g., a mass change as a function of temperature or humidity; a solvent or water content, in terms of, e.g., mass or a percentage; or a peak position, such as, e.g., in analysis by IR or Raman spectroscopy or XRPD; indicate that the value or range of values may deviate to an extent deemed reasonable to one of ordinary skill in the art while still describing the particular solid form"(page 4). Simply stating that the definition of the term “about” is value or range of values may deviate to an extent deemed reasonable to one of ordinary skill in the art does not provide a standard for ascertaining the requisite degree because different people of ordinary skill in the art may differ on what is reasonable deviation. For instance the scope of the claims is unclear because it is unclear if the peaks can only be ±0.2 degrees from the peak value and this is what is meant by about or if the term about mean the peaks can be more or less than ±0.2 degrees of the peak value.
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 (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 12-13, 19-20, 24-25, 29-30 is/are rejected under 35 U.S.C. 102(a)(1)/ 102(a)(2) as being clearly anticipated by SHENG (SHENG et al., US2020270213A1, 2020-08-27, IDS).
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The reference SHENG teaches the following in paragraphs [0057-0059].
This anticipates claim 12 because 26.0 is about 24.6, 18.7 is about 18.5 +0.2, and 18.3 is about 17.8+0.2. Since “[a] chemical composition and its properties are inseparable … if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.” See MPEP. This anticipates claims 13.
This anticipates claim 19 because it has two peaks at 17.8 ±0.2 which is about 17.7 ±0.2, and 20.8 ±0.2 which is the same as 20.8 ±0.2. Since “[a] chemical composition and its properties are inseparable … if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.” See MPEP. This anticipates claims 20.
This anticipates claim 24 because it has two peaks at 3.7 ±0.2 which is about 4.0 ±0.2, and 19.0 ±0.2 which is the same as 19.0 ±0.2. Since “[a] chemical composition and its properties are inseparable … if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.” See MPEP. This anticipates claims 25.
The reference SHENG teaches “According to the purpose of the present invention, the fifth aspect of the present invention is to provide a pharmaceutical composition, which is used for treating or preventing a disease that is related to differentiation or proliferation in a mammal. The disease includes but not limited to tumors (especially malignant tumors), autoimmune diseases, skin diseases, atherosclerosis and parasitic diseases. The term “preventing” or “prevention” as used in the present invention refers to prevention of a disease or a symptom in an individual who may be predisposed to suffer from the disease or symptom but has not yet suffered or shown a disease or symptom of the disease. The term “treating” or “treatment” as used in the present invention refers to one or more of the following: (1) inhibiting the disease; for example, inhibiting the disease or symptom in an individual suffering from or showing the disease or symptom. (2) ameliorating the disease; for example, ameliorating, reversing, delaying the disease and/or symptom in an individual suffering from or showing the disease or symptom. The pharmaceutical composition comprises a therapeutically and/or preventively effective amount of pharmaceutical active ingredient selected from the crystalline forms of entinostat-containing compounds of the present invention, and at least one pharmaceutically acceptable excipient or carrier… According to the present invention, the method for treating human patients comprises administrating Compound A, Compound B, Compound C or Compound D. The above compounds are prepared into formulation forms that can be administered nasally, sublingually, rectally, orally, intravenously, intramuscularly or subcutaneously, including tablets, capsules, film-coated tablets, films, suppositories, implants, injectable sterile aqueous or oil solutions, suspensions, emulsions, ointments, creams, gels, patches and nasal sprays. Compound A, Compound B, Compound C, or Compound D can be administered orally in single or multiple doses at a total dosage of 0.001 to 100 mg/kg of mammalian body weight per day. Another preferred dosage ranges from 0.01 to 0.5 mg/kg body weight per day, given orally in single or multiple doses. The specific dosage and time interval need to be adjusted according to the individual conditions of the subject, such as gender, age, weight, health conditions, tolerance, etc.”[0086-0087] and “The compound can contain at least one compound specified herein, using the pharmaceutical composition made by medicinal carrier, excipient, adjuvant or using capsules, sachets, cachets, paper or absorbable carrier in other shell forms or using disposable container such as ampoules or enclosed. The carrier, excipient, adjuvant can be a solid, semi-solid or liquid material. The pharmaceutical compositions of the present invention can use carrier, excipient and adjuvant such as starch, sugar, syrup, sorbitol, mannitol, glycol, paraffin, kaolin clay, calcium silicate, silica, polyvinylpyrrolidone, calcium phosphate, cocoa butter, esters, oils, alginates, gums, methylcellulose, microcrystalline cellulose, lubricants, binders, disintegrants and so on”[0088]. This anticipates claims 29-30.
Conclusion
Claims 12-31 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALISON AZAR SALAMATIAN whose telephone number is (703)756-4584. The examiner can normally be reached Mon-Thurs 7:30am-5pm EST Friday 7:30-4pm EST (every other Friday off).
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/A.A.H./ Examiner, Art Unit 1627
/Kortney L. Klinkel/ Supervisory Patent Examiner, Art Unit 1627