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 .
DETAILED ACTION
STATUS OF THE CLAIMS: Claims 1-8 and 11-18 are pending in this application.
Claim Objections
Claims 1-6, 11-15 objected to because of the following informalities:
(a) Claims 1-6 recite “A 1,3,40oxadiazole derivative compound.” Examiner suggests amending claims to “A compound….”. Additionally, in claim 1, the claim recites “in Chemical Formula I above,”. This should be deleted and “(I)” should be inserted following the structure; and
(b) Claims 12-15 recite “thereo” instead of “thereof”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112, second paragraph
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 1-8 and 11-18 (including claims dependent thereon and claims that relate back to independent and dependent claims) 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 pre-AIA the applicant regards as the invention.
(a) Claims 1-8 and 11-18 recite the term “derivative”, which implies more than what is being positively recited. The term "derivative" can include any or all organic compounds derived from the core structure, and thus, it is unclear what is included or excluded. Examiner suggests deleting the term in all claims.
(b) Claims 2-5 recite “Chemical Formula above”, however, no chemical formula exist in the claim.
Claim Rejections - 35 USC § 112, first paragraph
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.
Claims 7-8, 11-15 and 17-18 (including claims dependent thereon and claims that relate back to independent and dependent claims) are 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.
Claims 7-8, 11-15 and 17-18 are directed to a method of preventing and treating histone deacetylase 6-mediated diseases. In light of this, it can be asserted that in spite of the vast expenditure of human and capital resources in recent years, no one drug has been found which is effective in preventing and treating all types of histone deacetylase 6-mediated diseases. In re Hokum, 226 USPQ 353 (ComrPats 1985).
The determination that “undue experimentation” would have been needed to make and use the claimed invention is not a single, simple factual determination. Rather, it is a conclusion reached by weighing all the above noted factual considerations. In re Wands, 858 F.2d at 737, 8 USPQ2d at 1404.
There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue”. These factors include, but are not limited to:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(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.
The breadth of the claims
The breadth of the instant claims is seen to encompass methods for preventing and treating all histone deacetylase 6-mediated diseases, by administering to a patient in need of such treatment a therapeutically effective amount of the compound of formula I. Applicant fails to disclose which specific diseases are treated. Thus, the claims are extremely broad.
The nature of the invention
The nature of the invention is the prevention and treatment of these disorders through the use of the claimed compound and derivatives thereof. Currently, there are no known agents that treat these disorders all inclusively.
The level of predictability in the art
The treatment and prevention of these disorders is highly unpredictable. 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).
The amount of direction provided by the inventor.
The applicant has not demonstrated sufficient guidance provided in the form of administration profiles, combination ratios of the active agents or reference to the same in the prior art to provide a skilled artisan with sufficient guidance to practice the instant treatment of disorders claimed. Further, the applicant discloses that an effective amount of the compound will be administered without providing any direction other than that the compounds of the invention have a high therapeutic index and follows this with a definition readily found in a basic pharmacology textbook. It should be noted that the therapeutic index of a drug in humans is almost never known and is only determined through clinical experience.
The existence of working examples.
There is not seen in the disclosure, sufficient evidence to support Applicant’s claims of treating of these disorders. 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, 27 USPQ2d 1510 (CAFC). The disclosure does not demonstrate sufficient evidence to support the applicant's claim to the treatment. There are not sufficient working examples or data from references of the prior art to provide a nexus between those examples and a method of treating the disorders with the claimed compound.
The level of one of ordinary skill.
The level of skill is that of one with a doctoral understanding of particular disease therapeutics. Applicant’s data is not convincing as to make the production and use of pharmaceutical compositions comprising the recited compounds feasible without undue, un-predictable experimentation.
The quantity of experimentation.
A great deal of experimentation is required for the method of preventing and treating these disorders. Furthermore, direction, in the form of examples, must be shown to determine what an effective dose may be. The references submitted do not demonstrate this. Therefore, one of ordinary skill in the art would require a significant amount of experimentation in order to determine the effective dosage to treat the multitudes of different types of diseases with the claimed compound individually or in combination with other therapeutic agents.
Thus, it can be safely concluded that the instant case fails to provide an enabling disclosure for preventing and treating histone deacetylase 6-mediated diseases.
Claims 1-6 are (including claims dependent thereon and claims that relate back to or refer to independent or dependent claims) are rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for some of the ring B, L1, L2 and various R groups listed within the specification of the current application, does not reasonably provide enablement for all of the ring B, L1, L2 and various R groups listed within the application. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make the invention commensurate in scope with these claims.
The test of enablement is whether one skilled in the art could make and use the claimed invention from the disclosures in the application coupled with information known in the art without undue experimentation. (United States v. Teletronics Inc., 8 USPQ2d 1217 (Fed. Cir. 1988)). Whether undue experimentation is needed is not based on a single factor, but rather a conclusion reached by weighing many factors (See Ex parte Forman 230 USPX 546 (BD. Pat. App. & Inter. 1986) and In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988).
1. Amount of guidance provided by Applicant.
While the Applicant has demonstrated within the application a select number of the heterocyclic compounds, the generic claims according to formula I (i.e., rings Z1-Z4, Y1-Y5 and various R groups—e.g., H, alkyl, heteroaryl, aromatic, heterocyclic) are massive, and only a small fraction of these compounds are disclosed, discussed, and their synthesis shown. In the claims and specification, applicants claim the following compound according to formula I:
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242
450
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,
wherein the various variables for heterocyclic core, includes for rings Z1-Z4, Y1-Y5 and various R groups—H, alkyl, heteroaryl, aromatic, and heterocyclic groups. However, the specification fails to teach all of these compounds, nor does the specification define the ring size, heteroatom, number and nature of substituents, and/or the exact point of contact with the atom(s) for the substituents.
2. Unpredictability in the art.
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. (USPQ 18, 24 (CCPA 1970). See In re Fisher, 427 F.2d 833, 839, 166.
3. Number of working examples.
Applicants have provided some working examples of the compounds (i.e., rings Z1-Z4, Y1-Y5 and various R groups—H, alkyl, heteroaryl, aromatic, and heterocyclic groups defined). However, these examples only read on a minute portion of the massive claims according to general formula I in the present application.
4. Scope of the claims.
The scope, of the claims, involves a plethora of compounds of general formula I:
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230
448
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,
wherein all the variables are defined in the claim. For example, in defining rings Z1-Z4, Y1-Y5 and various R groups are:
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432
800
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132
790
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Thus, the scope of the claims is very broad.
5. Nature of the invention.
The nature of this invention relates generally to some heterocyclic compounds for treating all histone deacetylase 6-mediated diseases.
6. Level of skill in the art.
The artisan using Applicant’s invention would be a chemist with a Ph.D. degree, and having several years of bench experiences.
MPEP § 2164.01 (1) 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).” Thus, this conclusion is clearly justified here. Therefore, Applicant is not enabled for all of these compounds or composition.
Conclusion
Claims 1-8 and 11-18 are pending. Claims 1-8 and 11-18 are rejected. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL V WARD whose telephone number is (571)272-2909. The examiner can normally be reached M-F 9am to 5pm.
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/PAUL V WARD/ Primary Examiner, Art Unit 1622
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