DETAILED ACTION
This Action is in response to the amendment filed on 12/23/2025, which has been entered.
Claims 10, 15-18 are pending and are under consideration.
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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 10, 15-18 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by U.S. 6,331,565 (“Dong”).
Claim 10 is drawn to a method for treating an ADP-ribosyl cyclase (ADPRC)-mediated disease, comprising administering an inhibitor against the activation of an ADP-ribosyl cyclase comprising an amino acid sequence of SEQ ID NO 1 or a naturally occurring variant thereof as an active ingredient to a subject, wherein the inhibitor is a compound selected from the group consisting of 4,4'-dihydroxyazobenzene, 2-(1,3-benzoxazol-2-ylamino)-1-methylquinazolin-4(1H)-one, and dicaffeoylquinic acid (DCQA).
Upon further review, it was determined that the phrase “for treating an ADP-ribosyl cyclase-mediated disease” appears as part of the preamble of the claim as an intended use of the claimed method and does not impart patentable weight to the claimed methods because the intended use (treating an ADPRC-mediated disease) does not impart a manipulative difference to the claimed as the claim does not require that the subject is “a subject in need thereof (i.e., the claim does not necessarily require that the subject actually has an ADPRC-mediated disease. See MPEP §2111.02 which states:
Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986) (The claims were directed to a method of enhancing color effects produced by ambient light through a process of absorption and reflection of the light off a coated substrate. A prior art reference to Donley disclosed a glass substrate coated with silver and metal oxide 200-800 angstroms thick. While Donley disclosed using the coated substrate to produce architectural colors, the absorption and reflection mechanisms of the claimed process were not disclosed. However, King’s specification disclosed using a coated substrate of Donley’s structure for use in his process. The Federal Circuit upheld the Board’s finding that "Donley inherently performs the function disclosed in the method claims on appeal when that device is used in ‘normal and usual operation’" and found that a prima facie case of anticipation was made out. Id. at 138, 801 F.2d at 1326. It was up to applicant to prove that Donley's structure would not perform the claimed method when placed in ambient light.)… Ex parte Novitski, 26 USPQ2d 1389 (Bd. Pat. App. & Inter. 1993) (The Board rejected a claim directed to a method for protecting a plant from plant pathogenic nematodes by inoculating the plant with a nematode inhibiting strain of P. cepacia. A U.S. patent to Dart disclosed inoculation using P. cepacia type Wisconsin 526 bacteria for protecting the plant from fungal disease. Dart was silent as to nematode inhibition but the Board concluded that nematode inhibition was an inherent property of the bacteria. The Board noted that applicant had stated in the specification that Wisconsin 526 possesses an 18% nematode inhibition rating.).
Dong teaches pharmaceutical compositions comprising a DCQA, as well as a method comprising administering to a patient a DCQA (e.g., see claims 1-6). Since Dong teaches a method comprising all of the active steps required by the claims, Dong anticipates the instant claims.
It is noted that a chemical composition and its properties are inseparable (In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963)), as are their processes and yields (In re Von Schickh, 362 F.2d 821, 150 USPQ 300 (CCPA 1966)). Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Moreover, the court in Integra Life Sciences I Ltd. v. Merck KGaA, 50 USPQ2d 1846 (DC SCalif, 1999) held that a reference teaching a process may anticipate claims drawn to a method comprising the same process steps, despite the recitation of a different intended use in the preamble or the later discovery of a particular property of one of the starting materials or end products.
Therefore, the claims are anticipated by Dong. It is noted that amending the phrase “to a subject” to “to a subject in need thereof” would obviate this rejection.
Claims 10, 15-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by KR-1020080061431 (hereafter “KIM”; of record – IDS citation).
Although the elected species if DSQA, upon further review of the KIM reference, it was determined that KIM taught the claimed method using 4.4’-dihydroxyazobenzene for treating diabetic nephropathy; therefore, the instant rejection is appropriate.
Claim 10 is described in the rejection above.
KIM teaches using 4.4’-dihydroxyazobenzene for treating diabetic nephropathy, including acute renal failure (see KIM’s reference, titled “Treatment for hypertension and diabetic nephropathy using ADP-ribosyl cyclase inhibitors”, claims 12-13, page 9 third full paragraph of the English translation of the KIM reference, and Example 8).
Regarding the limitations related to “for treating an ADPRC-mediated disease” (claim 10), “wherein the ADPRC-mediated disease is renal disease” (claim 15), “wherein the renal disease is renal failure, nephropathy…” (claim 16), “wherein the renal failure is chronic renal failure, acute renal failure…” (claim 17), “wherein the nephropathy is diabetic nephropathy” (claim 18), these limitations only further limit the preamble intended use phrase “for treating and ADPRC-mediated disease”, thus they only further limit the intended use of the claimed invention and do not necessarily require that the subject has the ADPRC-mediated disease. Nevertheless, KIM teaches treating diabetic nephropathy and acute renal failure as indicated above. Furthermore it is noted that diabetic nephropathy is recognized as a leading cause of chronic renal failure.
Therefore, KIM anticipates the instant claims.
Conclusion
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J. E. Angell
Primary Examiner
Art Unit 1637
/J. E. ANGELL/Primary Examiner, Art Unit 1637