DETAILED ACTION
Claims 1, 4-5, 7, 9-10, 15-18, 20, 30, 44, 54, 73, 76, 79, 136-137, 153 are pending in the instant application.
2. Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 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.
Claim 137 is rejected under 35 U.S.C. 112, first paragraph, because the specification, does not reasonably provide enablement for treating and preventing any and all diseases. The specification does not enable any person skilled in the art to which, or with which it is most nearly connected, to make and/or 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 compounds 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 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 medical treatment 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 afflicted before the fact. 5) The artisan using Applicants invention would be a Board Certified physician who specialized to treat 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 disorder diseases 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 disorders generally. That is, the skill is so low that no compound effective generally against 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 diseases and on the multitude of compounds embraced by Formula (I).
The Examiner suggests deletion of the word “prevention”.
3. Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived 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(a) 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.
Claims 1, 4-5, 7, 9-10, 15-18, 20, 30, 44, 54, 73, 76, 79, 136-137, 153 are rejected under 103(a) as being unpatentable over Keswani et al., US 2016/0220710 and Fink US 7,971,588.
Determination of the scope and content of the prior art (MPEP §2141.01)
Keswani et al. on page 7, discloses clofazimine can be in crystalline drug formulation and used for anti-inflammatory response in the lung. Clofazimine can be used to treat asthma, COPD, bronchitis on page 9, paragraph 124-125. Clofazimine can be used in a form suitable for administration by inhalation on page 10, paragraph 132.
Fink et al., disclose amikacin can be used to treat pulmonary disease in abstract. Fink discloses amikacin can be used to treat patient by administering to the patient through a ventilator, a nebulized aerosol within inhalation phase on column 2-3.
Ascertainment of the difference between the prior art and the claims (MPEP §2141.02)
The difference between the instant claims and the prior art is that the instant claims have “a pharmaceutical composition of clofazimine and amikacin”, which the prior art disclose “clofazimine” can be used in a form for administration by inhalation and “amikacin” can be used by administering within inhalation phase.
Finding of prima facia obviousness-rational and motivation (MPEP §2142.2143)
Clofazimine can used by inhalation to treat lung disease. Amikacin also can used by inhalation to treat lung disease. One having ordinary skill in the art can combine these two compounds (clofazimine and amikacin) by administering to a patient to treat lung disease even better.
4. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Niloofar Rahmani whose telephone number is
571-272-4329. The examiner can normally be reached on Monday through Friday from 8:30 am to 5:00 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Renee Claytor, can be reached on 571-272-8394. The fax phone number for the organization where this application or proceeding is assigned is 703-872-9306.
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/NILOOFAR RAHMANI/
02/26/2026
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