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
Claims 1-6 are pending and examined on the merits herein.
Priority
This application claims the following priority:
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Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: 8D, 9A and 9B. While the Drawings include “FIG. 8A, 8B, 8C,” and “FIG. 9,” they do not include FIG. 8D, FIG. 9A or FIG 9B. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Interpretation
-Regarding instant claim 4, 2APB and YM58483/TTP2 are interpreted as 2-aminoethoxydiphenyl borate (2APB) and (N-[4-[3,5-Bis(trifluorom ethyl)-1H-pyrazol-1-yl]phenyl]-4-methyl-1,2,3-thiadiazole-5-carboxamide (YM58483/BTP2), respectively, as taught in [0021] of the instant specification.
-Regarding instant claim 4, AnCoA4 is interpreted as
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, as evidenced by PubChem (Jamaicin, IDS of 08/05/2024).
Regarding instant claim 4, Orai1+ si RNA is interpreted as a genus of polynucleotides binding to and being complementary to the Orai1 mRNA, such that translation is suppressed, a member of which, for example, is Bovell’s (US 2018/0037894, IDS of 08/05/2024) SEQ ID. 1, ([0102]: “knock-down of Orai1 using siRNA of SEQ ID. 1”).
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 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)(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.
(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 1-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yildar (Protective effect of 2-aminoethyl diphenylborinate on acute ischemia-reperfusion injury in the rat kidney, published 2014, PTO-892).
Regarding claims 1-4, Yildar teaches the protective effect of 2-aminoethyl diphenylborinate (2-APB) on acute ischemia-reperfusion (I/R) injury in the rat kidney (title abstract). Yildar specifically teaches a method of intravenously administering 2-APB before renal ischemia, wherein the 2-APB reduces oxidative stress and damage caused by renal I/R injury (abstract; pg. 684, 2.2).
Yildar teaches that 2-APB can be used as an effective agent against I/R injury in the kidney (abstract, paragraph spanning pgs. 688-689).
Further regarding claim 1, and regarding claims 5, and 6, while Yildar does not explicitly teach inhibiting store operated Ca2+ entry through Orai1 channel into a cell by decreasing an amount of a Ca2+ release-activated Ca2+ channel pore forming subunit Orai1, or the further effects of this inhibition as recited in instant claims 5 and 6, it is reasonable to assume that the method of Yildar would have the same effects/properties since it administers the same Store Operated Calcium Entry (SOCE) inhibitor, 2APB, in the same dosage amount (Yildar exemplifies a dosage amount of 2mg/kg (abstract) and the instant specification teaches a dosage amount of about 0.5ug/kg to about 30mg/kg ([0028]) for the same purpose (treating a kidney injury, specifically ischemia-reperfusion injury) in the same population (patients with a kidney injury, i.e., ischemia-reperfusion injury), as that taught by the instant specification and claims.
Thus, while Yildar does not explicitly teach inhibiting store operated Ca2+ entry thorough Orai1 channels into a cell by decreasing an amount of a Ca2+ release-activated Ca2+ channel pore forming subunit Orai1, or the functional limitations of instant claims 5 and 6, burden is on Applicant to show that the prior art does not have these properties.
See also MPEP 2112.02.
Moreover, further regarding claims 5 and 6, MPEP 2111.04 states, a “‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’” In this case, the wherein/whereby clauses expresses the desired result of the positive step of administering the 2mg/kg of 2APB to a mammal in need of treatment for ischemia-reperfusion kidney injury. As such, this limitation is met by the teachings of Yildar.
Applicants are reminded that the office does not have the facilities and resources to provide the factual evidence needed in order to establish that the effects of the method of the prior art does not possess the same material, structural and functional characteristics of the claimed method. In the absence of evidence to the contrary, the burden is on the applicant to prove that the claimed product is different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN WELLS whose telephone number is (571)272-7316. The examiner can normally be reached M-F 7:00-4:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James (Jim) Alstrum-Acevedo can be reached on 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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/LAUREN WELLS/Examiner, Art Unit 1622
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