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 .
Status of Claims
Claims 11-26 are pending in the instant application.
Claims 1-10 have been canceled.
Withdrawn Objections/Rejections
Applicant’s amendment is sufficient to overcome the rejection of Claims 12 and 17 under 35 U.S.C. 112(b). These rejections are hereby withdrawn.
Claim Objections
Claim 19 is objected to because of the following informalities:
Claim 19 recites “R1 and R2” in the first line of the claim. Elsewhere, “R1 and R2” is presented with the 1 and 2 as subscripts, R1 and R2. This includes both the variable definitions 1-4 recited instantly at Claim 19, and in the compound formulas at Claim 17, from which Claim 19 depends. For consistency, “R1 and R2” in the first line of the claim should be amended to read “R1 and R2”.
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.
Claims 14-16 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method of treating an anxiety disorder comprising administering the agarofuran-based compound according to Claim 11, 12, or 13, the pharmaceutically acceptable salt thereof, does not reasonably provide enablement for a method of treating an anxiety disorder comprising administration of a prodrug of the agarofuran-based compound of Claim 11, 12, or 13. 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 and use the invention commensurate in scope with these claims.
Pursuant to In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988), one considers the following factors to determine whether undue experimentation is required: (1) The breadth of the claims, (2) The nature of the invention, (3) The state of the prior art, (4) The level of one of ordinary skill, (5) The level of predictability in the art, (6) The amount of direction provided by the inventor, (7) The existence of working examples and (8) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
Nature of the invention:
The invention is drawn to a method of treating an anxiety disorder comprising administering compounds as recited at instant Claims 11-13.
Breadth of the invention:
The scope of the claimed invention is very broad, as it is drawn not only to the compounds as recited in Claims 11-13, but also prodrugs thereof. A person having ordinary skill in the art would readily envisage a myriad of distinct compounds that satisfy the definition of “prodrug”.
Level of ordinary skill in the art:
An ordinary artisan in the area of drug development would have experience in synthesizing chemical compounds for particular activities. The synthesis of new drug candidates, while complex, is routine in the art. The process of finding new drugs that have in vitro activity against a particular biological target (i.e., receptor, enzyme, etc.) is well known. Additionally, while high throughput screening assays can be employed, developing a therapeutic method, as claimed, prior to synthesizing and testing compounds is generally not well-known or routine, given the complexity of certain biological systems.
State of the prior art and predictability in the art:
With respect to prodrugs, Walther et. al. (“Prodrugs in medicinal chemistry and enzyme prodrug therapies”, Advanced Drug Delivery Reviews, 2017) represents the state of the prior art.
At Page 66, Table 1, Walther teaches several reasons by which a person having ordinary skill in the art would be drawn to the use of prodrugs including a parent drug compound having poor aqueous solubility, poor absorption from the gastro-intestinal tract into the blood, and poor rates of cell entry. Further, at the last paragraph of Page 66, Walther teaches that design strategy for a prodrug depends on the structural features of the parent drug molecule and availability of the appropriate chemical functionalities that can be used to mask pharmacodynamic activity of the drug through attachment of a modifying group.
Taken together, Walther establishes “prodrugs” encompass a myriad of diverse chemical moieties that are structurally distinct from the parent drug molecule.
The amount of direction provided and working examples:
The compound core depicted with specific substituents represents a narrow subgenus for which applicant has provided sufficient guidance to make and use; however, the disclosure is not sufficient to allow extrapolation of the limited examples to enable the scope instantly claimed, drawn to the administration of any prodrug. The instant disclosure does not teach a person having ordinary skill in the art which prodrugs are suitable for use in the context of the instant invention, nor would it be readily understood based on the instant disclosure the benefit of administering a prodrug rather than the agarofuran-based compound itself.
Within the specification, “specific operative embodiments or examples of the invention must be set forth. Examples and description should be of sufficient scope as to justify the scope of the claims.” Markush claims must be provided with support in the disclosure for each member of the Markush group. Where the constitution and formula of a chemical compound is stated only as a probability or speculation, the disclosure is not sufficient to support the claims identifying the compound by such composition or formula. See MPEP 608.01(p).
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 that Applicant is not enabled for administering any prodrug of the instantly claimed compounds.
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 14-16 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.
Claim 14 recites the limitation "the pharmaceutical composition comprising the same" in the last two lines of the claim. There is insufficient antecedent basis for this limitation in the claim, as Claim 11, from which Claim 14 depends, does not recite a pharmaceutical composition.
Claim 15 recites the limitation "the pharmaceutical composition comprising the same" in the last two lines of the claim. There is insufficient antecedent basis for this limitation in the claim, as Claim 12, from which Claim 15 depends, does not recite a pharmaceutical composition.
Claim 16 recites the limitation "the pharmaceutical composition comprising the same" in the last two lines of the claim. There is insufficient antecedent basis for this limitation in the claim, as Claim 13, from which Claim 16 depends, does not recite a pharmaceutical composition.
Conclusion
Claims 14-16 are rejected.
Claim 19 is objected to.
Claims 11-13 and 17-18 and 20-26 are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL JOHN BURKETT whose telephone number is (703)756-5390. The examiner can normally be reached Monday - Friday.
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/D.J.B./Examiner, Art Unit 1624
/BRENDA L COLEMAN/Primary Examiner, Art Unit 1624
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