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 .
Application Status
Claims 1-8 and 10-15 are currently pending.
Priority
The instant application claims priority as follows:
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Information Disclosure Statement
The information disclosure statement (IDS) submitted on 29 Jan 2024 was in compliance with the provisions of 37 CFR 1.97 and 37 CFR 1.98. The IDS was considered. A signed copy of form 1449 is enclosed herewith.
Claim Objections
Claim 8 is objected to because of the following informalities: claim 8 reads, in part,
“A pharmaceutical composition, characterized in comprising…”. The phrase “characterized in” and the phrase “comprising” are each open-ended transitional phrases under US practice. However, the single phrase “characterized in comprising“ is non-standard. Appropriate correction is required.
As one potential means for overcoming the instant objection, Applicant may wish to consider removing the “characterized in" phrase so that the resulting claim 8 reads, in part, “A pharmaceutical composition, comprising…”
Claim Rejections - 35 USC § 112(b)
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.
Indefiniteness
Claims 6 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention. The phrase "such as" (which is used repeatedly throughout the claim) renders the claim indefinite because it is unclear whether the limitations following the phrase "such as" are part of the claimed invention. See MPEP § 2173.05(d).
As one potential means for overcoming the instant rejection, Applicant may wish to consider removing each instance of the "such as" phrase along with the narrow range or limitation that follows the "such as" phrase.
Claim Rejections - 35 USC § 112(a)
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.
Claims 10-15 are rejected under 35 U.S.C. 112(a) because the specification, while being enabling for treating certain cancers, does not reasonably provide enablement for preventing any form of cancer. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
Suggestion for Overcoming the Instant Rejection
As one potential means for overcoming the instant rejection, Applicants may wish to consider amending the claims to remove the recitations related to the prevention of diseases from the claimed subject matter.
Support for the Instant Rejection
The ordinary meaning of the term “prevention” as used in the claimed invention requires that no associated symptom will ever occur in a subject after treatment by the claimed method. Applying the broadest reasonable interpretation, the rejected claims, drawn to the prevention of certain cancers, does not comply with the enablement requirement due to the undue amount of experimentation required by one of ordinary skill in the art to predictably practice the claimed method.
To be enabling, the specification of the patent application must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1561 (Fd. Cir. 1993). Explaining what is meant by "undue experimentation," the Federal Circuit has stated that:
The test is not merely quantitative, since a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which experimentation should proceed to enable the determination of how to practice a desired embodiment of the claimed invention. PPG v. Guardian, 75 F.3d 1558, 1564 (Fed. Cir. 1996). As pointed out by the court in In re Angstadt, 537 F.2d 498 at 504 (CCPA 1976), the key word is "undue", not "experimentation".
The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth in In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 wherein, citing Ex parte Forman, 230 USPQ 546 (Bd. Apls. 1986) at 547, the court recited eight factors:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The level of skill of those in the art;
(D) The state of the prior art;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention
based on the content of the disclosure.
These factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved. In re Fisher, 57 CCPA 1099, 1108, 427 F.2d 833, 839, 166 USPQ 18, 24 (1970). The relevant factors are addressed below on the basis of comparison of the disclosure, the claims and the state of the prior art in the assessment of undue experimentation:
1. The breadth of the claims; and the nature of the invention
Claims 10-15 broadly encompasses not only a method of treating certain cancers, but also a method preventing the occurrence of certain cancers, the method comprising administering to a subject in need thereof a therapeutically effective amount of a recited compound.
2. Relative skill of those in the art
The relative skill of those in the art is high, generally that of an M.D. or Ph.D. The artisan using Applicant’s invention would generally be a physician with a M.D. degree and several years of experience. However, the skill of those in the art is outweighed by the state and unpredictable nature of the art, as discussed below.
3. State and predictability of the art
Regarding the prospect of preventing most chronic diseases, including cancer, “[f]or most chronic diseases, as well as infectious diseases without effective vaccines and high vaccination coverage, we are never able to fully prevent an outcome at an individual level even if we can reduce risk at a population level. Both the Human Papilloma Virus and Hepatitis B vaccines hold tremendous promise for major declines in virally-driven cancers, but these vaccines are an exception as most cancers do not have a vaccine.” See Walker et al. (Cancer Causes & Control (2021) 32:919–922) at page 919. This article demonstrates that the art of preventing cancer is extremely unpredictable.
It is well established that “the scope of enablement varies with the degree of unpredictability of the factors involved” and physiological activity is considered to be an unpredictable factor. See In re Fisher, 166 USPQ 18, at 24 (In cases involving unpredictable factors, such as most chemical reactions and physiological activity, the scope of enablement obviously varies inversely with the degree of unpredictability of the factors involved); Nationwide Chemical Corporation, et. al. v. Wright, et. al., 192 USPQ 95 (one skilled in chemical and biological arts cannot always reasonably predict how different chemical compounds and elements might behave under varying circumstances); Ex parte Sudilovsky 21 USPQ2d 1702 (Applicant’s invention concerns pharmaceutical activity. Because there is no evidence of record of analogous activity for similar compounds, the art is relatively unpredictable); In re Wright 27 USPQ2d 1510 (the physiological activity of RNA viruses was sufficiently unpredictable that success in developing specific avian vaccine was uncertain).
4. The amount of direction or guidance provided; and the presence or absence of working examples
The specification provides no particular direction or guidance for determining the particular administration regimens (e.g. timing, administration routes, etc.) necessary to achieve prevention of any form of cancer.
5. The quantity of experimentation necessary
Because of the known unpredictability of the art (as discussed in supra) and in the absence of experimental evidence commensurate in scope with the claims, the skilled artisan would not accept that the claimed method could be predictably used as a preventative for cancer.
Genentech Inc. vs. Nova Nordisk states, "[A] patent is not a hunting license. It is not a reward for a search but a compensation for its successful conclusion and 'patent protection' is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable" (42 USPQ 2d 1001, Fed. Circuit 1997). Determining whether a method comprising administering the recited compound compounds would prevent the aforementioned conditions or disorders would require synthesis of the compound, formulation into a suitable dosage form, and subjecting it to clinical trials or to testing in an assay known to correlate to clinical efficacy of such treatment. Furthermore, in vitro and in vivo assays do not always correlate to efficacy in humans. As such, undue experimentation would be required given the limited guidance and direction provided by Applicants.
Accordingly, the inventions of claims 10-15 do not comply with the enablement requirement of 35 U.S.C 112(a), since to practice the claimed invention a person of ordinary skill in the art would have to engage in undue experimentation with no assurance of success.
Allowable Subject Matter
Claim 6 would be allowable if rewritten to overcome the rejection under 35 U.S.C. 112(b) set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claim 8 would be allowable if rewritten to overcome the objection set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claims 1-5 and 7 are allowed. The following is a statement of reasons for the indication of allowable subject matter:
CN 112028880 A discloses an indole pyrimidine compound (RN 2564638-97-5) having the following structure:
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CN 109705117 A discloses an indole pyrimidine compound (RN 2376629-64-8) having the following structure:
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CN 116354940 A discloses an indole pyrimidine compound (RN 2945220-41-5) having the following structure:
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While the compounds disclosed in the above references each share structural similarities with Formula I from Claim 1, as well as with each of the two species from Claim 7, none of the disclosed examples anticipates or renders obvious the claimed invention.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRADLEY S MAYHEW whose telephone number is
571-272-8428. The examiner can normally be reached Mon-Fri, 11:00 AM-7:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, CLINTON A BROOKS can be reached at 571-270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BSM/ Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
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