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 . Claims 1-20 are pending in this application.
Election/Restrictions
Applicant’s election without traverse of Group I and a single disclosed species (compound of Example 10) in the reply filed on 07/20/2026 is acknowledged.
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The examiner searched the elected species and found no prior art. The search was expanded and stopped when a prior art was found. Upon further review of the case and search results, the Restriction Requirement between Groups I and II are withdrawn.
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.
Claim 15 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for the treatment of lung cancer, does not reasonably provide enablement for the prevention of cancer or lung cancer or the treatment of cancer in general. 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. It is recited a method of preventing cancer or lung cancer or the treatment of cancer in general, but the specification is not enabled for such as a scope.
A number of factors are relevant to whether undue experimentation would be required to practice the claimed invention, including “(1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.” In re Wands, 858 F.2d at 737, 8 USPQ2d at 1404 (Fed. Cir. 1988).
(1). Breadth of Claims: Claim 15 is directed to a method of preventing cancer or lung cancer or the treatment of cancer in general that comprises administering to a subject in need of such treatment a therapeutically effective amount of the compound or the pharmaceutically acceptable salt thereof.
a. Scope of use - The scope of use that applicants intend to claim is very broad. For a compound or genus to be effective against cancer cells generally is contrary to medical science. Cancer is a disease, which can take place in virtually any part of the body. There is a vast range of forms that it can take, causes for the problem, and biochemical pathways that mediate cancer. There is no common mechanism by which all, or even most, cancers arise. Accordingly, treatments for a cancer or inhibition of cancer cells are normally tailored to the particular type of cancer cells present, as there is no, and there can be no “magic bullet” against cancer cells generally.
Even the most broadly effective antitumor agents are only effective against a small fraction of the vast number of different cancers known. This is true in part because cancers arise from a wide variety of sources, such as viruses (e.g. EBV, HHV-8, and HTLV-1), exposure to chemicals such as tobacco tars, genetic disorders, ionizing radiation, and a wide variety of failures of the body's cell growth regulatory mechanisms. Different types of cancers affect different organs and have different methods of growth and harm to the body, and different vulnerabilities.
b. Scope of Compounds - The scope of the compounds is also broad. It is apparent that hundreds of thousands of combinations of compounds can be created from the definitions, owing especially to broad scope of R1-R4 and n.
(2). Direction of Guidance: The amount of direction or guidance is minimal. There is no guidance for a method of preventing cancer or lung cancer or the treatment of cancer in general.
(3). State of Prior Art: There is no evidence of record that compounds structurally similar to the cycloalkyl or haloalkyl compound are in use for the prevention of lung cancer or the treatment/prevention of cancer in general.
(4). Working Examples: Test procedures and data are provided in the specification at pages 167-170, however, there is nothing in the disclosure regarding how this data correlates to the prevention of lung cancer or treatment or prevention of cancer in general.
(5). Nature of the Invention and Predictability: The invention is directed to the prevention of cancer or treatment or treatment of cancer in general. 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). Cancers are especially unpredictable due to their complex nature.
(6). The Quantity of Experimentation Necessary: Immense, because so many cancerous cells are covered; see part (1).
(7). The Relative Skill of Those in the Art: The relative skill is extremely very low. To
this day, there is no magic bullet that can treat cancer in general.
In regard to prevention, to this day the only means available is the treatment of patients suffering from specific cancers such as lung cancer and not the prevention of a healthy patient from getting cancer in the first place. In order to overcome this case, applicants have to delete the method of prevention from claim 15.
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 15 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 15, the phrase “optionally, the EGFR-mediated disease is selected from a cancer; optionally, the EGFR-mediated disease is selected from lung cancer” is not clear. Do applicants intend the treatment or prevention of cancer in general or lung cancer? Or both? If applicants intend “cancer”, what is the significance of reciting “lung cancer” that is already embraced in “cancer”? In order to overcome this rejection, it is recommended that applicants amend the claim so that the claim is drawn to the treatment (not prevention) of lung cancer.
Allowable Subject Matter
Claims 1-14 and 16-20 are allowed.
Information Disclosure Statement
8. Applicant’s Information Disclosure Statement, filed on 01/20/2026 and 05/30/2024 has been acknowledged. Please refer to Applicant’s copies of the 1449 submitted herewith.
Conclusion
9. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kahsay Habte Ph.D. whose telephone number is (571)272-0667. The examiner can normally be reached on 8:30 - 5:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JEFFREY MURRAY can be reached on 571-272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Kahsay Habte/
Primary Examiner, Art Unit 1624
July 31, 2026
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