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 1-13, 16-19 and 23-25 are pending in this application.
Specification
The disclosure is objected to because of the following informalities: At paragraph [0010] line 4, the phrase “dissociated to from” should read as “dissociated to form”.
Appropriate correction is required.
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 23 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. In claim 23, it is recited a method of treating cancer in general, but the specification is not enabled in such 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 23 is directed to a method of treating cancer in general that comprises the step of administering to a subject a therapeutically effective amount of the compound of claim 1.
Scope of use for claim 23 - The scope of use that applicants intend to claim is very broad. To this day, it is impossible to treat all cancer cells with a single pharmaceutical drug. Please see below for the explanations that cancer cells are broad and different one from the other. Cancer cells can exist in different parts of the body and the nature of these cancer cells differs one from the other. For example, the treatment of bone cancer cannot be the same as the treatment of skin cancer. The drug that inhibits bone cancer cells may require more doses than the cancer cells in skin. The form of delivery for both said cancers (radiation, ointment, tablets, etc.) is not the same. For instance, one has to get deep to the bones to inhibit the cancer cells in the bones, while applying the drug on the surface of the skin can inhibit cancer cells on skin. It is also a fact that some cancer cells need more drugs than the others. Which diseases (cancer cells) are inhibited by the administration of the drug and which are not? Applicants claim that all cancer cells can be treated by single pharmaceutical drugs, thus is not enabled.
It can be shown that cancer cells in general are extraordinarily 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.
(2). Direction of Guidance: The amount of direction or guidance is minimal. There is no guidance in the specification for the treatment of cancer in general.
(3). State of Prior Art: There is no evidence of record that compounds structurally similar to the compound recited in claim 1 is in use for the treatment of cancer in general, or anything remotely close to cancer in general.
(4). Working Examples: There is kinetic data at pages 26-27 and also other data for synthesis, dialysis, molecular simulations throughout the specification, but there is no way to convert this data into specific useful knowledge, especially in view of the difficult nature of some of these disorders.
(5). Nature of the Invention and Predictability: The invention is directed to inhibiting cancer cells 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. Note that treatment of one type of cancer could not be necessarily the same for the other type.
(6). 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 cells in general.
(7). The Quantity of Experimentation Necessary: Immense, because so many cancerous cells are covered; see part (1).
MPEP 2164.01(a) states, “A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557,1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993).” That conclusion is clearly justified here.
In order to overcome this rejection, the examiner recommends that applicants incorporate claim 24 into claim 23.
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 1-5 , 13 and 16 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:
a. Regarding claim 1, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
b. Claims 13 and 16 are rejected because both claims recite “pharmaceutical composition that are unclear. In claim 13, it is unclear if the claim is drawn to a compound claim or a pharmaceutical composition claim. It starts as a compound claim but ends up as a pharmaceutical composition claim. What is it?
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In claim 16, it is recited "A pharmaceutical composition comprising (i) the compound of claim 1; and (ii) a pharmaceutical suitable carrier, diluent, or excipient” but it is unclear why it is separated by (i) and (ii). It appears that the pharmaceutical suitable carrier is a choice and not part of the composition. In order to overcome this rejection, the examiner recommends that applicants delete claim 13 and amend claim 16 as “A pharmaceutical composition comprising the compound of claim 1 and a pharmaceutical suitable carrier, diluent, or excipient”.
Objection
7. Claims 6-12, 17-19 and 24-25 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Information Disclosure Statement
8. Applicant’s Information Disclosure Statement, filed on 01/04/2024 and 10/06/2023 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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/Kahsay Habte/
Primary Examiner, Art Unit 1624
December 9, 2025