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 .
Claim Objections
Claims 15 – 17 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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.
Claim 6 is rejected under 35 U.S.C. § 112, first paragraph, as containing 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 invention appears to employ novel biological materials, specifically Cystobasidium laryngis IV17-028 KCTC 13720BP strain or a culture medium. Since the biological materials are essential to the claimed invention, they must be obtainable by a repeatable method set forth in the specification or otherwise readily available to the public. If the biological materials are not so obtainable or available, the requirements of 35 U.S.C. § 112 may be satisfied by a deposit of the biological materials.
The specification does not disclose a repeatable process to obtain the biological materials, and it is not apparent if the biological materials are readily available to the public. It is noted that Applicant has deposited the biological materials (specification page 22 lines 14 – 15), but there is no indication in the specification as to public availability. If the deposit is made under the Budapest Treaty, then an affidavit or declaration by Applicant, or a statement by an attorney of record over his or her signature and registration number, stating that the specific biological materials have been deposited under the Budapest Treaty and that the biological materials will be irrevocably and without restriction or condition released to the public upon the issuance of a patent, would fully satisfy the deposit requirement.
If the deposit has not been made under the Budapest Treaty, then in order to certify that the deposit meets the criteria set forth in 37 C.F.R. §§ 1.801-1.809, Applicant may provide assurance of compliance by an affidavit or declaration, or by a statement by an attorney of record over his or her signature and registration number, showing that:
(a) during the pendency of this application, access to the invention will be afforded to the Commissioner upon request;
(b) all restrictions upon availability to the public will be irrevocably removed upon granting of the patent;
(c) the deposit must be maintained in a public depository for a period of 30 years or 5 years after the last request or for the effective life of the patent, whichever is longer;
(d) a test of the viability of the biological material at the time of deposit will be made (see 37 C.F.R. §1.807) and
(e) the deposit will be replaced if it should ever become inviable.
Applicant' s attention is directed to M.P.E.P. § 2400 in general, and specifically to § 2411.05, as well as to 37 C.F.R. § 1.809(d), wherein it is set forth that “the specification shall contain the accession number for the deposit, the date of the deposit, the name and address of the depository, and a description of the deposited material sufficient to specifically identify it and to permit examination.” The specification should be amended to include this information; however, Applicant is cautioned to avoid entry of new matter into the specification by adding any other information.
Applicant is advised that the address for the ATCC is:
American Type Culture Collection
10801 University Boulevard
Manassas, VA 20110-2209
Claim Rejections - 35 USC § 112
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 3 and 4 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.
Regarding claim 3, the claim recites the diphenazine compound, the enantiomer thereof or the pharmaceutically acceptable salt thereof of claim 1, wherein X is
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, and R1 is
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, -COOH, or -COCH3. However, the structure of X as recited in instant claim 3 does not contain an R1 portion. Therefore, given that the structure does not contain R1 it is unclear which portion of the molecule R1 is defining. As a consequence, one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Specifically one of ordinary skill in the art would not be reasonably apprised of whether a diphenazine compound wherein X is
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1) requires R1 or not and 2) where R1 is located. Therefore, given the uncertainty around a diphenazine compound wherein X is
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; claim 3 is rejected under 35 U.S.C. 112(b). Nevertheless, for the sake of applying prior art the limitations from claim 1 wherein R2 and R3 are defined will be used.
Regarding claim 4, the claim recites the diphenazine compound, the enantiomer thereof or the pharmaceutically acceptable salt thereof of claim 1, wherein X is
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, and R1 is
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, -COOH, or -COCH3. However, the structure of X as recited in instant claim 4 does not contain an R1 portion. Therefore, given that the structure does not contain R1 it is unclear which portion of the molecule R1 is defining. As a consequence, one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Specifically one of ordinary skill in the art would not be reasonably apprised of whether a diphenazine compound wherein X is
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1) requires R1 or not and 2) where R1 is located. Therefore, given the uncertainty around a diphenazine compound wherein X is
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; claim 4 is rejected under 35 U.S.C. 112(b). Nevertheless, for the sake of applying prior art the limitations from claim 1 wherein R4 are defined will be used.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1 – 8, and 11 – 12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a products of nature without significantly more. The claims recite the diphenazine compound of Chemical Formula 1 is isolated from a Cystobasidium laryngis IV17-028 KCTC 13720BP strain or a culture medium. This judicial exception is not integrated into a practical application because the claims direct to diphenazine compounds that are not markedly different from the diphenazine compounds produced by Cystobasidium laryngis IV17-028 KCTC 13720BP strain. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims direct specifically to diphenazine compounds by structures.
Discussion of the Prior Art
The closet prior art of Laursen et. al. ((2004), Phenazine Natural Products: Biosynthesis, Synthetic Analogues, and Biological Activity, Chem. Rev., 104, 1663 – 1685) teach that saphenic acid-derived metabolites have diverging structures, including antibiotic activity in the mono-phenazine derivatives 28, 29, and 33 (Figure 4) and radical scavenging activity of the di-phenazines 30-32 of structures
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(page 1668 Figure 4).
However, Laursen et. al. fail to teach a diphenazine compound of Chemical Formula 1 below, an enantiomer thereof or a pharmaceutically acceptable salt thereof:
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R1, R2, R3, and R4 are each independently
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, -OH, -COH, -COOH, -COOCH3, or -COCH3 (claim 1). Specifically, Laursen et. al. fail to teach a diphenazine compound, which has the free carboxylic acid in combination with either the connectivity of X as recited, and the recited R1, R2, R3, and R4. Moreover, the prior art fails to provide motivation for modifying the prior art of Laursen et. al.. Given that the prior art of Laursen et. al. fails to anticipate o5r render obvious the compounds of the instant claims 1 – 8, and 11 – 12 are free of the prior art. Moreover, instant claims 15 – 17 that direct to a method of using the diphenazine compound of instant claim 1 are free of the prior art.
Conclusion
Claims 1 – 8, and 11 – 12 are rejected. Claims 15 – 17 are objected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAWANNA S WHITE whose telephone number is (703)756-4687. The examiner can normally be reached 7:00 am - 5:00 pm [EST] M - Th.
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/DAWANNA SHAR-DAY WHITE/Examiner, Art Unit 1627