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 .
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.
Claim Status
Claims 1-30, 37-50, and 54-55 are cancelled.
Claims 63-66 are newly added.
Claims 31-36, 51-53, and 56-66 are pending and are examined on the merits in this prosecution.
CLAIM REJECTIONS
Enablement Rejection
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.
Claims 31-36, 51-53, and 56-66 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claims contains 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.
Applicant's claimed invention is directed to a method of “preventing” stroke in a patient suffering from heart failure by administration of pharmaceutical compositions comprising an effective amount of omecamtiv mecarbil. However, the specification does not sufficiently establish that the pharmaceutical compositions can be used as claimed. The specification sets forth evidence that the incidence of stroke is decreased by administration of omecamtiv mecarbil, but does not demonstrate that the incidence of stroke is prevented or eliminated as required by claim 31 (see Specification, ¶ [0220]).
Indefiniteness Rejection
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.
Claim 33 is 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 pre-AIA the applicant regards as the invention.
Claim 33 recites a method of preventing a stroke in a patient suffering from heart failure by administering an effective amount of omecamtiv mecarbil to a patient who has suffered a fatal stroke. Since the claim appears to recite administration of the drug to a deceased patient, it is unclear what quantity of the drug would be considered an effective amount
Technical Background Material
The following prior art is made of record and not relied upon is considered pertinent to applicant's disclosure:
1. Kim (“Heart Failure as a Risk Factor for Stroke,” Journal of Stroke 2018;20(1): 33-45) discloses that heart failure itself increases the risk of stroke. Kim further discloses that “a severely impaired left ventricular ejection fraction is a well-known risk factor for stroke.” See pg 35, right column, first partial paragraph).
2. Teerlink (“A novel approach to improve cardiac performance: cardiac myosin activators,” Heart Fail Rev (2009) 14:289–298) discloses (Abstract)t:
A new class of pharmacologic agents, cardiac myosin activators, directly targets the kinetics of the myosin head. In vitro studies have demonstrated that these agents increase the rate of effective myosin cross-bridge formation, increasing the duration and amount of myocyte contraction, and inhibit non-productive consumption of ATP, potentially improving myocyte energy utilization, with no effect on intracellular calcium or cAMP. Animal models have shown that this novel mechanism increases the systolic ejection time, resulting in improved stroke volume, fractional shortening, and hemodynamics with no effect on myocardial oxygen demand, culminating in significant increases in cardiac efficiency.
CONCLUSION
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL P COHEN whose telephone number is (571)270-7402. The examiner can normally be reached on M-Th 8:30-5:30; F 9-4.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana S. Kaup, can be reached on (571) 272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL P COHEN/Primary Examiner, Art Unit 1612
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