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, 6-7, 9, 11-13, 16, 18-19, 21-23, 25, 28, 31, 33, 36, 38 and 49 are pending in this application.
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, 6-7, 9, 11-13, 16, 18-19, 21-23, 25, 28, 31, 33, 36, 38 and 49 (including claims dependent thereon or claims that relate back to independent or 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “therapeutic agents” in claims 1, 16, 28 and 49 is a relative term which renders the claim indefinite. The term is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Examiner suggests incorporating claim 16 into claim 1 or list the therapeutic agents intended (e.g., “selected from the group consisting of ….”).
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.
Claim 38 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.
Claim 38 is directed to a method of treating a disease and 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 a disease or 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 treating a disease, by administering to a patient in need of such treatment a therapeutically effective amount of the composition in claim 1. 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 treatment of diseases through the use of the claimed composition and derivatives thereof. Currently, there are no known agents that treat 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 diseases. 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 various diseases’ 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 a disease.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 9 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Duran et al., (US Pub. 20190060312).
Applicants claim the following composition:
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Duran teaches a composition comprising a first polymer, second polymer and a therapeutic agent. (See Abstract, and paragraphs [0176] and [0195]-[0196].
Duran does not explicitly disclose the molar ratio of total weight of the one or more therapeutic agents to a total weight of the first and second polymers as at least 2% (compared to Duran’s 1.5%).
It would have been obvious to one having ordinary skill in the art at the time of the invention to modified the composition of Duran to make the ratio of a total weight of the one or more therapeutic agents to a total weight of the first and second polymers at least 2%, since where the general conditions of the claim are disclosed in the prior art, and discovering the optimum or workable ranges involves only a routine skill in the art. The motivation for doing so would be to tune the specific amount of therapeutic agent depending on the dosage required for the particular subject and depending on the agent used, and to find the most effective dosing regimen by routine experimentation. Thus, one skilled in the art looking for an alternative composition would modify the composition of Duran to make the ratio of a total weight of the one or more therapeutic agents to a total weight of the first and second polymers at least 2%, since where the general conditions of the claim are disclosed in the prior art and thus, discovering the optimum or workable ranges involves routine experimentation in skill in the art.
Regarding claim 9, Duran teaches the composition of claim 1, wherein the molar ratio between the first and second polymers is about 2:1. (See para. [0031]).
Regarding claim 13, Duran teaches the composition of claim 13 comprising a bulking agent. (See paragraph [0202]).
Since Applicant’s claims are prima facie obvious in view of the teachings of Duran, Applicant’s claims are obvious, and therefore, rejected under 35 U.S.C. 103.
Claims 1, 6, 16, 22-23, 25 and 28 (including claims dependent thereon) are rejected under 35 U.S.C. 103 as being unpatentable over Duran et al., (US Pub. 20190060312) in view of Recinos et al. (US. Pub. 2011/00313010).
Applicants claim the following composition:
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Duran teaches a composition comprising a first polymer, second polymer and a therapeutic agent. (See Abstract, and paragraphs [0176] and [0195]-[0196].
Regarding claim 6, Duran does not explicitly disclose wherein the ratio of the one or more therapeutic agents to the total weight of the first and the second polymers is from 30%-145%.
Recinos is in the field of polymer therapeutic agent compositions and teaches that these are typically provided in a polymeric matrix and teaches wherein the ratio of the weight of the one or more therapeutic agents to the total weight of the first and the second polymer is from 30%-145%. (See para. [0020].
It would have been obvious to one having ordinary skill in the art at the time of the invention to be motivated to modify and combine the teachings Duran and Recinos to design a composition with the drug loading teaching of Recinos for the purpose of using an effective dosage of the drug based on known pharmacokinetics of the drugs, prior studies using Gillaidel and animal studies. (See Recinos at para. [0066]). The effective dosages can be easily determined by those skilled in the art based on the known pharmacokinetics of the drug. All of the moieties are taught in the art. Therefore, one of ordinary skill in the art, would be motivated to combine the teachings of Duran and Recinos when confronted with an alternate composition, to optimize the treatment and since the effective dosages can be easily determined by those skilled in the art based on the known pharmacokinetics of the drug, and thus is obvious.
Since Applicant’s claims are prima facie obvious in view of the teachings of Duran and Recinos, Applicant’s claims are obvious, and therefore, rejected under 35 U.S.C. 103.
Regarding claim 16, Duran fails to disclose wherein the one or more therapeutic agents comprises one or more chemotherapeutic drugs. However, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the composition of Duran with the chemotherapeutic teaching of Recinos for the purpose of using a chemotherapeutic agent to treat tumors and cancer as need by the patient to prolong survival. (See Recinos, para. [0004]).
Regarding claim 22, Duran fails to discloses wherein the one or more chemotherapeutic drugs comprise an imidazotetrazine compound. Recinos, in paragraphs [0004] and [0020], teaches wherein the one or more chemotherapeutic drugs comprises an imidazotetrazine compound. However, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the composition of Duran with the chemotherapeutic teaching of Recinos for the purpose of using temozolomide to treat tumors and cancers as needed by the patient to prolong survival of life.
Regarding claim 23, Duran fails to discloses wherein imidazotetrazine compound is temozolomide. Recinos, in paragraphs [0004] and [0020], teaches wherein imidazotetrazine compound is temozolomide or an analog thereof. However, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the composition of Duran with the chemotherapeutic teaching of Recinos for the purpose of using Temozolomide to treat tumors and cancers as needed by the patient to prolong survival of life.
Regarding claim 25, Duran fails to discloses wherein a ratio of a weight of the temozolomide compound thereof to the total weight of the first and the second polymers is from 30%-100%. Recinos, in paragraph [0020] states that in the case of just temozolomide and the polymer matric, the ratio of the temozolomide to the polymer is about 67%-233%, and thus teaches wherein a ratio of a weight of the temozolomide compound thereof to the total weight of the first and the second polymers is from 30%-100%. However, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the composition of Duran with the temozolomide concentration teaching of Recinos for the purpose of using an appropriate dosage of the drug depending on the needs of the patient or subject.
Regarding claim 28, Duran fails to discloses wherein the chemotherapeutic drugs comprise an imidazotetrazine compound and a taxane compound. Recinos, in paragraphs [0020]-[0021] and [0095], teaches wherein the chemotherapeutic drugs comprise an imidazotetrazine compound and a taxane compound. However, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the composition of Duran with the chemotherapeutic teaching of Recinos for the purpose of using these compounds for a synergistic effect to treat a condition depending on the needs of the patients (e.g., to treat gliomas, tumors and various cancers) as needed by the patient to prolong survival of life.
Claims 1 and 12 (including claims dependent thereon) are rejected under 35 U.S.C. 103 as being unpatentable over Duran et al., (US Pub. 20190060312) in view of Sawhney et al. (US. Pub. 2014/0363498).
Applicants claim the following composition:
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Duran teaches a composition comprising a first polymer, second polymer and a therapeutic agent. (See Abstract, and paragraphs [0176] and [0195]-[0196].
Regarding claim 12, Duran does not explicitly disclose wherein the hydrogel is from about 20%-70% g/mL measured as total weight of the solid from by volume of the water.
Sawhney is in the field of hydrogels with drugs and teaches in paragraph [0066] that the hydrogel from about 20%-70% g/mL measured as total weight of the solid from by volume of the water. (See Abstract and para. [0066]).
It would have been obvious to one having ordinary skill in the art at the time of the invention to be motivated to modify the teachings Duran with the hydrogel teaching of Sawhney for the purpose of using the correct solids content to achieve the desired mechanical properties and biocompatibility. The solids content of the hydrogel can affect its mechanical properties and biocompatibility. All of the moieties are taught in the art. Therefore, one of ordinary skill in the art, motivated to modify the teachings of Duran with the hydrogel teaching of Sawhney when confronted with an alternate composition for the purpose of using the correct solids content to achieve the desired mechanical properties and biocompatibility is obvious.
Since Applicant’s claims are prima facie obvious in view of the teachings of Duran and Sawhney, Applicant’s claims are obvious, and therefore, rejected under 35 U.S.C. 103.
Claims 1, 16, 18-19 and 21 (including claims dependent thereon) are rejected under 35 U.S.C. 103 as being unpatentable over Duran et al., (US Pub. 20190060312) in view of Mongelli et al. (US. Pat. 5.569.720).
Applicants claim the following composition:
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Duran teaches a composition comprising a first polymer, second polymer and a therapeutic agent. (See Abstract, and paragraphs [0176] and [0195]-[0196].
Regarding claim 16, Duran does not explicitly disclose wherein one or more therapeutic agents comprises one or more chemotherapeutic drugs.
Mongelli is in the field of polymer drug compositions and teaches in column 2, lines 21-22 and column 1, lines 24-26, one or more therapeutic agents comprises one or more chemotherapeutic drugs. (See Abstract and column 2, lines 21-22 and column 1, lines 24-26,).
It would have been obvious to one having ordinary skill in the art at the time of the invention to be motivated to modify the teachings Duran with the paclitaxel teaching of Mongelli for the purpose of using paclitaxel as it is an effective antitumor agent based on the needs of the patient. All of the moieties are taught in the art. Therefore, one of ordinary skill in the art, motivated to modify the teachings of Duran with the with the paclitaxel teaching of Mongelli for the purpose of using paclitaxel as it is an effective antitumor agent based on the needs of the patient.
Regarding claim 18, Duran does not explicitly disclose wherein one or more chemotherapeutic drugs comprises a taxane compound.
Mongelli is in the field of polymer drug compositions and teaches in column 2, lines 21-22 and column 1, lines 24-26, chemotherapeutic drugs comprises a taxane compound. (See Abstract and column 2, lines 21-22 and column 1, lines 24-26,).
It would have been obvious to one having ordinary skill in the art at the time of the invention to be motivated to modify the teachings Duran with the taxane compound teaching of Mongelli for the purpose of using taxane as it is an effective antitumor agent based on the needs of the patient. All of the moieties are taught in the art. Therefore, one of ordinary skill in the art, motivated to modify the teachings of Duran with the with the taxane compound teaching of Mongelli for the purpose of using the taxane as it is an effective antitumor agent based on the needs of the patient.
Regarding claim 19, Duran does not explicitly disclose wherein the taxane compound is paclitaxel.
Mongelli is in the field of polymer drug compositions and teaches in column 2, lines 21-22 and column 1, lines 24-26, wherein the taxane compound is paclitaxel. (See Abstract and column 2, lines 21-22 and column 1, lines 24-26,).
It would have been obvious to one having ordinary skill in the art at the time of the invention to be motivated to modify the teachings Duran with the taxane compound, paclitaxel teaching of Mongelli for the purpose of using paclitaxel as it is an effective antitumor agent based on the needs of the patient or subject. All of the moieties are taught in the art. Therefore, one of ordinary skill in the art, motivated to modify the teachings of Duran with the with the paclitaxel teaching of Mongelli for the purpose of using the paclitaxel as it is an effective antitumor agent based on the needs of the patient.
Regarding claim 21, Duran does not explicitly disclose wherein a ratio of a weight of the paclitaxel to the total wight of the first and the second polymers the is from 1.5%-43%.
Mongelli is in the field of polymer drug compositions and teaches in column 2, lines 25-27 and column 6, lines 42-43, that weight of the paclitaxel to the total wight of the first and the second polymers the is from 1.5%-43%. (See Abstract and column 2, lines 25-27 and column 6, lines 42-43).
It would have been obvious to one having ordinary skill in the art at the time of the invention to be motivated to modify the teachings Duran with the paclitaxel concentration teaching of Mongelli for the purpose of using the correct dosage of the paclitaxel to treat oncological disorders based on age, weight, and condition of the patient or subject. All of the moieties are taught in the art. Therefore, one of ordinary skill in the art, motivated to modify the teachings of Duran with the paclitaxel concentration teaching of Mongelli for the purpose of using the correct dosage of the paclitaxel to treat oncological disorders based on age, weight, and condition of the patient or subject.
Since Applicant’s claims are prima facie obvious in view of the teachings of Duran and Mongelli, Applicant’s claims are obvious, and therefore, rejected under 35 U.S.C. 103.
Claims 1 and 33 (including claims dependent thereon) are rejected under 35 U.S.C. 103 as being unpatentable over Duran et al., (US Pub. 20190060312) in view of Guarnieri et al. (US. Pub. 2008/00996910).
Applicants claim the following composition:
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Duran teaches a composition comprising a first polymer, second polymer and a therapeutic agent. (See Abstract, and paragraphs [0176] and [0195]-[0196].
Regarding claim 33, Duran does not explicitly disclose wherein the composition is in a pellet form.
Guarnieri is in the field of drug compositions and teaches the composition in a form of a pellet. (See Abstract and para. [0015]).
It would have been obvious to one having ordinary skill in the art at the time of the invention to be motivated to modify the teachings Duran with the pellet form teaching of Guarnieri for the purpose of using a desired administration form depending of the therapeutic agent and the patient or subject such as for an analgesic for long term pain relief. All of the moieties are taught in the art. Therefore, one of ordinary skill in the art, motivated to modify the teachings of Duran with the with the pellet form teaching of Guarnieri for the purpose of using a desired administration form depending of the therapeutic agent and the patient or subject such as for an analgesic for long term pain relief.
Since Applicant’s claims are prima facie obvious in view of the teachings of Duran and Guarnieri, Applicant’s claims are obvious, and therefore, rejected under 35 U.S.C. 103.
Claims 1 and 36 (including claims dependent thereon) are rejected under 35 U.S.C. 103 as being unpatentable over Duran et al., (US Pub. 20190060312) in view of Ridden et al. (US. Pub. 20160206567).
Applicants claim the following composition:
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Duran teaches a composition comprising a first polymer, second polymer and a therapeutic agent. (See Abstract, and paragraphs [0176] and [0195]-[0196].
Regarding claim 36, Duran does not explicitly disclose wherein the composition is in an ointment base form.
Ridden is in the field of polymer drug compositions and teaches the composition in a form of an ointment base form and states that the composition can be applied topically in the form of a lotion, cream or ointment. (See Abstract and paragraphs [0041] and [0044]).
It would have been obvious to one having ordinary skill in the art at the time of the invention to be motivated to modify the teachings Duran with the ointment base form teaching of Ridden for the purpose of providing a delivery form for topical administration as needed based on the therapeutic agent used, such as fugal nail and skin infections. All of the moieties are taught in the art. Therefore, one of ordinary skill in the art, motivated to modify the teachings of Duran with the with the ointment base form teaching of Ridden for the purpose of providing a delivery form for topical administration as needed based on the therapeutic agent used.
Since Applicant’s claims are prima facie obvious in view of the teachings of Duran and Ridden, Applicant’s claims are obvious, and therefore, rejected under 35 U.S.C. 103.
Conclusion
Claims 1, 6-7, 9, 11-13, 16, 18-19, 21-23, 25, 28, 31, 33, 36, 38 and 49 are pending in this application. Claims 1, 6-7, 9, 11-13, 16, 18-19, 21-23, 25, 28, 31, 33, 36, 38 and 49 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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