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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on November 1, 2021 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 1 – 12 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 1 and its dependents are draw to a method for identifying a compound as a candidate for treating arrhythmic cardiac disorder, however are rendered indefinite for reciting “SAN” without first spelling out the term first followed by the abbreviation.
In claim 7, the phrase “to thereby determine an effect of the compound on a heart rate” is confusing because the phrase does not positively recite any active steps to perform, nor does it correlate any result with a particular outcome such that one would know what is being determined. As such, it is unclear how the phrase intends to further limit the method of claim 1. Moreover, the claim appears to be drawn to a method different from identifying candidate compounds. For purposes of examination, the claim is interpreted as an intended use of an identified candidate compound, e.g., the identified candidate compound is administered to a subject with arrhythmic cardiac disorder followed by the mental step of observing any result.
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)(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 – 2 and 4 – 12 are rejected under 35 U.S.C. 102a1 as being anticipated by Haron-Khun et al. (2016) (IDS filed 11.01.2021, NPL #16).
Regarding claims 1 and 10 – 11, Haron-Kuhn teaches a method comprising contacting TRAM-34 (a compound identified as a SK4 potassium channel blocker) with SAN cells (cells expressing SK4 potassium channel), wherein the compounds were determined to produce a bradycardiac effect (slow pace rate) and reduce tachycardia (increased pace rate), and identified as candidates for treating CPVT (a ventricular arrhythmic cardiac disorder) (abstract).
Regarding claim 2, Haron-Kuhn identifies TRAM-34 sensitive currents in SAN cells, indicating that TRAM-34 (candidate compound) was contacted with SAN cells and a determination was made whether SK4 current amplitude was reduced by the compound (abstract).
Regarding claims 4 – 6, the method occurs in vitro and SAN cells are hiPS-CMs (human induced pluripotent stem cell derived cardiomyocytes, or cells that express SK4 potassium channel), from healthy subject, subjects with CPVT and mice with knock out/in CPVT, which are post natal (abstract).
Regarding claims 7 – 8, TRAM-34 is administered to CPTV knock in and knock out mice, or post natal subjects suffering from CPVT (an arrhythmic cardiac disorder), monitored via ECG and determined effects of the TRAM-34 on the heart rate of the subject (abstract).
Regarding claim 9, although the reference does not indicate the compound is identified for treat treating atrial arrhythmia, the method steps are the same. In this regard, when practicing the methods of Haron-Khun, one would be identifying compounds for reducing a pacing rate for any arrhythmic cardiac disorder, regardless of its mechanical origin.
Regarding claim 12, the TRAM-34 is identified as a candidate compound using human cells, or for treating a human subject (abstract).
Therefore, the reference anticipates the claimed subject matter.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1 – 3 are rejected under 35 U.S.C. 103 as being unpatentable over Haron-Khun et al. (2016) (IDS filed 11.01.2021, NPL #16) in view of Senatore et al. (2011).
Regarding claim 1, Haron-Kuhn teaches a method comprising contacting TRAM-34 (a compound identified as a SK4 potassium channel blocker) with SAN cells (cells expressing SK4 potassium channel), wherein the compounds were determined to produce a bradycardiac effect (slow pace rate) and reduce tachycardia (increased pace rate), and identified as candidates for treating CPVT (an arrhythmic cardiac disorder) (abstract).
Regarding claim 2, Haron-Kuhn identifies TRAM-34 sensitive currents in SAN cells, indicating that TRAM-34 (candidate compound) was contacted with SAN cells (cells expressing SK4 potassium channel) and a determination was made whether SK4 current amplitude was reduced by the compound (abstract).
Regarding claim 3, Haron-Khun does not teach the method wherein TRAM-34 is exposed to transfected cells ectopically expressing SK4 channels. However, the reference teaches the method can be practiced with SAN cells, hiPS-CMs (human induced pluripotent stem cell derived cardiomyocytes, or cells that express SK4 potassium channel), from healthy subject, subjects with CPVT and mice with knock out/in CPVT (abstract). In this regard, the reference demonstrates a variety of routinely used cell types and sources as cells that can be used to assay or determine whether SK4 current amplitude is reduced. At the time the claims were filed, transfected cells expressing desired traits were commonly used in the art when assaying effects on cell traits. In support, Senatore teaches in vitro expression and electrophysiological recording of recombinant voltage-gated ion channels (i.e., SK4 potassium channels) in cultured human embryonic kidney cells (HEK-293T) is a ubiquitous research strategy (abstract), that transfection is a common method for producing these cells and provides a means for optimizing transfection strategy (abstract). Therefore, at the time the claims were filed, it would have been obvious to one of ordinary skill in the art to apply common research strategies in the methods of Haron-Khun as a matter of routine practice and with a reasonable expectation for successfully identifying compounds for treating CPVT.
Thus, the invention as a whole is prima facie obvious over the references, especially in the absence of evidence to the contrary.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUTH A DAVIS whose telephone number is (571)272-0915. The examiner can normally be reached Monday - Friday (8am - 4pm).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fereydoun Sajjadi can be reached at 571-272-3311. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RUTH A DAVIS/Primary Examiner, Art Unit 1699