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 77-96 are pending in this application.
Claim Rejections - 35 USC § 112, 2nd 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 77-96 (including claims dependent thereon and claims that relate back to independent claim 77) 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 77, 79, 82-87 and 93 define variables (where applicable) as carbocycle or carbocyclyl. The terms are indefinite since the specification does not define the ring size and nature of substituents, and the exact point of contact with the atom(s) for the substituents.
(b) Claim 77 recites the term “adamantly” and “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.
(c) Applicant failed to particularly point out the identity or define the spacer or linker moiety X in claim 78, rendering the claims incomplete.
(d) Claim 79 is rejected as being indefinite for reciting “functional group”. Are additional radicals intended? The Examiner suggests adding the specific functional groups intended to claim.
(e) Regarding claim 92, the compounds (e.g., AD-3302, etc.) listed in the claim render the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Applicant is reminded that a claim should be complete by itself. These claims are deemed to be incomplete because it incorporates reference to compounds or a table in the specification. Examiner suggests adding the compound to the claim (i.e., structure or compound chemical name). Correction is required.
Claim Rejections - 35 USC § 112, 1st 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 77-96 (including claims dependent thereon and claims that relate back to independent claim 77) 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 claims contain 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 77, 79, 82-87 and 93 define variables (where applicable) as carbocycle or carbocyclyl are rejected under 35 U.S.C. 112, 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. The claims are not commensurate in scope as to the possibilities for the substituent carbocyclic residue in the various R definitions. They are open-ended and all encompassing. The specification does not enable any person skilled in the art to make and use the invention commensurate in scope with these broad claims, which embrace a diversity of hetero and aryl rings at various locations on the morpholine core.
There are many factors to be considered when in evaluating the enablement question. 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 heterocyclic compounds of the following formula (I):
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containing a carbocycle ring (i.e., R), which are drawn to a homogenous group of compounds not remotely commensurate in scope to Applicant’s claims. Thus, the claims are too broad. The claims encompass species that applicant has not taught how to make and use.
The nature of the invention
The nature of the invention in the instant application is drawn to claims which embrace a diversity of chemically and physically distinct compounds, wherein R is an unsubstituted or substituted, single or fused, aromatic or an unsubstituted or substituted, fused or single carbocycle, etc. While many compounds are disclosed, there is insufficient guidance for preparing additional antagonists, which would be effective since the compounds are drawn to a homogenous group of compounds not remotely commensurate in scope to Applicant’s claims. Only compounds wherein R is
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,
have been made. `
The level of predictability in the art
This area of activity can be expected to be highly structure specific and unpredictable, as in generally true for chemically-based pharmacological activity. In view of the structural divergence in the claims, one skilled in the art could not reasonably extrapolate the activities of some of the claimed compounds to the other structurally divergent compounds embraced by the claims which have not been tested. In cases directed to chemical compounds which are being used for their physiological activity, the scope of the claims must have a reasonable correlation to the scope of enablement provided by the specification. See In re Surrey 151 USPQ 724 regarding sufficiency of disclosure for a Markush group. No reasonable assurance has been made that the instant compounds as an entire class have the required activities needed to practice the invention.
The existence of working examples.
There is not seen in the disclosure, sufficient evidence to support Applicant’s claims. No testing data is provided for any of the compounds listed in the specification. Examples should be of sufficient scope as to justify the scope of the claim. The definition of the various R variables on the heterocyclic ring system embrace many structurally divergent groups not represented at all in testing, since testing for the instant compounds is not seen in the specification.
The level of one of ordinary skill.
The level of skill is that of one with a doctoral understanding of organic/medicinal chemistry and, one skilled in the art could not reasonably extrapolate the activities of some of the claimed compounds to the other structurally divergent compounds embraced by the claims.
Thus, it can be safely concluded that the instant case fails to provide an enabling disclosure in the instant case for the scope being claimed.
Claim 96 is rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for “treating” some of the disorders, does not reasonably provide enablement for “preventing” or “prophylaxis”. 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. Applicant is entitled to treatment or treating, not “prevention” or “preventing”.
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 treating and preventing biological effect associated with activity of MetAp2, various angiogenesis disorders, cancer, pulmonary and fibrosis, ocular neovascular diseases, wounds, chronic ulcer, ischemic stroke, myocardial infarction, angina pectoris, peripheral artery disease, critical limb ischemia, diabetic foot ulcer, cerebrovascular dementia, pulmonary fibrosis, hepatic fibrosis, endometriosis, arthritis, autoimmune diseases, obesity and microsporidiosis, and ocular and dermal disorders by administering to a patient in need of such treatment a therapeutically effective amount of the compound claim. Applicant failed to exactly defined how to prevent these diseases. Additionally, it is clear that Applicant has not limited his definition of prevention to one particular disease. Thus, the claim is extremely broad.
The nature of the invention
Currently, there are no known agents with the therapeutic efficacy to prevent these disorders. The art does not disclose an active agent or combination of active agents, which is recognized as prevention for the conditions cited supra. The prior art does not teach or disclose a treatment modality wherein healthy subjects are treated with an active agent or agents and there is no evidence that none of the associated symptoms or disease state characteristics are ever manifested. The disclosure does not direct the skilled artisan to an art, which satisfies the requirement for preventing a disease state associated with these disorders.
The level of predictability in the art
Since the art does not disclose any therapeutic preventative agents, the skilled artisan would not predict, in the absence of proof to the contrary, that the active agent(s) instantly claimed are efficacious in preventing the conditions as broadly claimed. The assertion of a broad application, as set forth in the instant method claims, necessarily requires evidence to support Applicant’s asserted methods. The Examiner notes there are no known agents recognized as preventative agents, and one of skill in this art could not predict, from the evidence of record, that the active agents asserted to be useful in the instantly claimed method, can indeed prevent these disorders.
The amount of direction provided by the inventor
The Examiner notes, there is not seen sufficient guidance provided in the form of administration profiles, combination ratios of the active agents or reference to same in the prior art to provide the skilled artisan with sufficient guidance to practice the instant preventative method. Prevention is seen to encompass administering the active agent to a subject in need, and noting the fact that symptoms of conditions such as these disorders never manifest themselves. The data and evidence provided in the instant disclosure leads the examiner to doubt the objective truth of assertions of prevention of any of the conditions.
The existence of working examples
There is not seen in the disclosure, sufficient evidence to support Applicant’s claims of prevention. There is not seen sufficient working examples or data from references of the prior art providing a nexus between that which applicant asserts as proof of a method for preventing these disorders from the data and evidence currently provided on the record to support methods drawn to preventing any condition.
The level of one of ordinary skill
The ordinary skill artisan would not be able to practice the claimed invention of preventing these disorders with the current disclosure.
The quantity of experimentation
A great deal of experimentation is required. In lieu of the fact that no animal models exist which can reasonably suggest successful prevention of these disorders, it may be necessary for an ordinary skilled artisan to have clinical data in order to practice the claimed invention.
Thus, it can be safely concluded that the instant case fails to provide an enabling disclosure for the prevention for these diseases.
Claim 96 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 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.
Claim 96 is directed to a method of treating various diseases and disorders, including treating the biological effect associated with activity of MetAp2, various angiogenesis disorders, cancer, pulmonary and fibrosis, ocular neovascular diseases, wounds, chronic ulcer, ischemic stroke, myocardial infarction, angina pectoris, peripheral artery disease, critical limb ischemia, diabetic foot ulcer, cerebrovascular dementia, pulmonary fibrosis, hepatic fibrosis, endometriosis, arthritis, autoimmune diseases, obesity and microsporidiosis, and ocular and dermal disorders.
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 treating various diseases or conditions, including biological effect associated with activity of MetAp2, various angiogenesis disorders, cancer, pulmonary and fibrosis, ocular neovascular diseases, wounds, chronic ulcer, ischemic stroke, myocardial infarction, angina pectoris, peripheral artery disease, critical limb ischemia, diabetic foot ulcer, cerebrovascular dementia, pulmonary fibrosis, hepatic fibrosis, endometriosis, arthritis, autoimmune diseases, obesity and microsporidiosis, and ocular and dermal disorders by administering to a patient in need of such treatment a therapeutically effective amount of the compound of formula (I). It is clear that Applicant has not limited his definition of treatment to a particular disease Thus, the claims are extremely broad.
The nature of the invention
The nature of the invention is the treatment of these disorders through the use of the claimed compound and derivatives thereof. Currently, there are no known agents that treat these diseases all inclusively.
The level of predictability in the art
The treatment 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 diseases or conditions associated with the formation of tau oligomers 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 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 the treatment of biological effect associated with activity of MetAp2, various angiogenesis disorders, cancer, pulmonary and fibrosis, ocular neovascular diseases, wounds, chronic ulcer, ischemic stroke, myocardial infarction, angina pectoris, peripheral artery disease, critical limb ischemia, diabetic foot ulcer, cerebrovascular dementia, pulmonary fibrosis, hepatic fibrosis, endometriosis, arthritis, autoimmune diseases, obesity and microsporidiosis, and ocular and dermal disorders.
Claim 96 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 claims contain 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.
Claim 96 is directed to a method of treating cancer. The term cancer is interpreted to include any and all forms of cancer. 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 treating all types of cancer because it is not a simple disease, nor is it even a single disease, but a complex of a multitude of different entities, each behaving in a different way. In re Hozumi, 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 treating cancer by administering to a patient in need of such treatment a therapeutically effective amount of compound of formula (I). Applicant fails to specify a particular cancer. Thus, the claims are extremely broad.
The nature of the invention
The nature of the invention is the treatment of cancer through the use of the claimed compound and derivatives thereof. Currently, there are no known agents that treat cancers all inclusively. (See Pinedo et al. pages 1-2).
The level of predictability in the art
The treatment of cancer is highly unpredictable due to the differing forms of cancerous cells, their location, their potential for metastases, the fact that cancer therapeutics is palliative rather than curative and that cancer treatment readily harms normal tissues. (See McMahon, page 5, col. 2).
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 cancer 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 cancer. 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 of cancer. 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 cancer with the claimed compound.
The level of one of ordinary skill.
The level of skill is that of one with a doctoral understanding of cancer therapeutics.
The quantity of experimentation.
A great deal of experimentation is required. In order for there to be a method of treating cancer generally, as claimed by the applicant, it would be necessary to show that a vast range of different types of cancers can be treated that have differing cell types, locations and potentials for metastases. 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 cancer 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 the treatment of cancer.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claims 77-95 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mauri et al. (Chem. Pharm. Bull’1992).
Applicant claims compounds and compositions of the following formula (I):
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wherein all the variables are defined in the claims.
This reference discloses the compounds and compositions of formula (I) on page 98 (See compound 23). (See Abstract, Table II and pages 96-101). The compounds and compositions read on the instant claims. Since this reference teaches the exact compounds and compositions, Applicant’s claims are anticipated, and thus, rejected under 35 U.S.C. 102(a).
Claims 77-95 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhang et al. (BioOrg & Med Chem Let 14’2004).
This reference discloses the compounds and compositions of formula (i) on page 646. (See Abstract, Figure 1). The compounds and compositions read on the instant claims. Since this reference teaches the exact compounds and compositions, Applicant’s claims are anticipated, and thus, rejected under 35 U.S.C. 102(a).
Claims 77-95 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stevenson et al. (WO2009/073445).
This reference discloses the compounds and compositions of formula (I) on pages 58, 62 88 105 and 129-130 (see compound 23). (See Abstract, Table II and pages 96-101). The compounds and compositions read on the instant claims. Since this reference teaches the exact compounds and compositions, Applicant’s claims are anticipated, and thus, rejected under 35 U.S.C. 102(a).
Claims 77-95 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Petersen et al. (WO2014/169026).
This reference discloses the compounds and compositions of formula (I) on page 67 (See compound paragraph [00259]). (See Abstract and entire document). The compounds and compositions read on the instant claims. Since this reference teaches the exact compounds and compositions, Applicant’s claims are anticipated, and thus, rejected under 35 U.S.C. 102(a).
Claims 77-95 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Olson et al. (WO02/42295).
This reference discloses the compounds and compositions of formula (I) on pages 56-57. (See Abstract and Examples 22-23). The compounds and compositions read on the instant claims. Since this reference teaches the exact compounds and compositions, Applicant’s claims are anticipated, and thus, rejected under 35 U.S.C. 102(a).
Claims 77-95 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Oku et al. (EP0354787).
This reference discloses the compounds and compositions of formula (I) on pages 14, 17 and 26-37. (See Example 8). The compounds and compositions read on the instant claims. Since this reference teaches the exact compounds and compositions, Applicant’s claims are anticipated, and thus, rejected under 35 U.S.C. 102(a).
Claims 77-95 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by al. (Chem. Pharm. Bull’1992).
This reference discloses the compounds and compositions of formula (I) on pages 17, 31, 3 and 48-49. (See Abstract, Exa,[;es 13, 46 and 54, and entire document). The compounds and compositions read on the instant claims. Since this reference teaches the exact compounds and compositions, Applicant’s claims are anticipated, and thus, rejected under 35 U.S.C. 102(a).
Conclusion
Claims 77-96 are pending. Claims 77-96 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James Alstrum-Acevedo can be reached at 571-272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PAUL V WARD/ Primary Examiner, Art Unit 1622
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