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 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.
Claim 6 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 6 recites the limitation " the method of claim 4, wherein the cardiac disorder is" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 6 which depends from claim 4 does not recite the disorder to be a cardiac disorder, but instead a neurological disorder.
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 2 and 20 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.
Claims 2 and 20 recites the limitation " wherein at least one substituent selected from the group of R1, R2, R3 and R5, as described with respect to Formula (I), is alkynyl or substituted alkynyl" in lines 1-3. There is insufficient antecedent basis for this limitation in the claim. R5 from claimed invention does not have an embodiment of alkynyl or substituted alkynyl. Therefore, the metes and bounds of the claims is unclear.
Claim Rejections - 35 USC § 102
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.
Claims 19 and 21 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Mannion et al. (US Patent No. 9162992).
Regarding claims 19 and 21, Mannion teaches a method of reducing or minimizing the open channel fraction of potassium maxi-K or BK channel in a subject in need thereof comprising administering an effective amount of Formula (I)
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and at least one pharmaceutically acceptable carrier. Of the above compound Mannion teaches
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(relevant to claims 19 and 21) (Pg. 5-6).
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.
Claims 1, 3, 7, 10-18 are rejected under 35 U.S.C. 103 as being unpatentable over Mannion et al. (US Patent No. 9162992) in view of Tao et al. Long-term hypoxia increases calcium affinity of BK channels in ovine fetal and adult cerebral artery smooth muscle, Am J Physiol Heart Circ Physiol, January 2015, Pages H707-H722.
The teachings of Mannion for the above 102 rejection of claims 19 and 21 is incorporated herein by reference.
Mannion teaches a method for the treatment of breathing control diseases or disorders of respiratory depression, dyspnea, hypoxia, chronic obstructive pulmonary disease (COPD) (which requires organ protection and associated with alterations in airway surface liquid and impaired mucociliary clearance) and hypercapnia (relevant to claims 3, 7, 10, 15-17) (Pg. 2) by route of inhalational, topical, oral, buccal, rectal, vaginal, intramuscular, subcutaneous, transdermal, intrathecal or intravenous (relevant to claim 18) (Pg. 3).
In terms of claims 11-13, the teachings of Mannion are also obvious to compound modulating the BK at one or both pore gate of the voltage sensing gate, RCK1, RCK2 and BK channel is located at a pre-synaptic site. It is known in the art the mechanism of BK channel as it relates to pore gate of the voltage sensing gate, RCK1, RCK2 and location of the BK channel on pre-synaptic site. Thus reducing or minimizing the open channel fraction of a BK channel as taught by Mannion one would modulate the pore gate, RCK1, RCK2 wherein the BK channel is located at the pre-synaptic site for hypoxia.
Mannion fails to teach the composition to treat the breathing control disease or condition which are modulated by BK channels, wherein the BK channel is located at one or both cardiovascular and smooth muscle.
Tao teaches large-conductance, calcium and voltage-activated potassium channel (BK) has a central role in the mechanism of oxygen (O2) sensing and its activity has been related to the hypoxic response (relevant to claim 1) (abstract). BK channels are also expressed in the regulation of cardiovascular smooth muscle (relevant to claim 14) (Pg. 2, 1st para.).
Therefore, it would have been obvious to someone of ordinary skill in the art at the time of filing to have used the compound taught by Mannion to treat a breathing control disease or condition which are modulated by BK channels, wherein the BK channel is located at one or both cardiovascular and smooth muscle. One would have been motivated to do so from the teachings of Mannion of the above compound to reducing or minimizing the open channel fraction of potassium maxi-K or BK channel as well as treat breathing control diseases or disorders of respiratory depression, dyspnea, hypoxia, chronic obstructive pulmonary disease, with the teachings of Tao on BK channels modulate breathing control diseases of hypoxia. There is a reasonable expectation of treating breathing control disease or condition which are modulated by BK channels by the compounds taught by Mannion.
Allowable Subject Matter
Claims 2, 4-6 and 8-9 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.
Conclusion
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MIKHAIL O'DONNEL. ROBINSON
Examiner
Art Unit 1627
/MIKHAIL O'DONNEL ROBINSON/Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627