DETAILED ACTION
Status of Application
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election with traverse of Group II, claims 178-184 and 187-190, in the reply filed on 5/13/2024 is acknowledged. The arguments have been fully considered and is found persuasive.
The restriction and species election requirement are withdrawn.
Claims 169-190 are included in the prosecution.
Claim Rejections – 35 U.S.C. 103
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 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 169-190 are rejected under 35 U.S.C. 103 as being unpatentable over Kobilka et al. (WO 2019/204768) hereinafter Kobilka.
Regarding claims 169-190, Kobilka discloses an agent for treating a pulmonary disease. The agent is an agent for treating asthma. The agent is nadolol [0251].
Kobilka discloses a method of treating a pulmonary disease, the method including administering to a subject in need thereof (e.g., a subject having the pulmonary disease or a subject who may develop the pulmonary disease) a therapeutically effective amount of a compound described herein, including embodiments. In embodiments the pulmonary disease is asthma [0255].
method of treating a pulmonary disease, the method including administering to a subject in need thereof (e.g., a subject having the pulmonary disease or a subject who may develop the pulmonary disease) a therapeutically effective amount of a compound described herein, including embodiments, and a ~2 adrenergic receptor modulator (e.g., inhibitor, antagonist, inverse agonist, agonist, allosteric modulator, allosteric inhibitor, allosteric antagonist, orthosteric inhibitor, orthosteric antagonist, orthosteric inverse agonist, or orthosteric agonist). In embodiments the pulmonary disease is asthma [0262]. Kobilka discloses an oral formulation [0138].
Kobilka discloses the terms "lung disease," "pulmonary disease," "pulmonary disorder," etc. are used interchangeably herein. Examples of lung diseases include asthma, Chronic Obstructive Pulmonary Disease (COPD) [0149].
Kobilka does not explicitly disclose the method as claimed together in one single embodiment.
However, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the teachings of Kobilka to arrive at the instant invention, with the motivation that Kobilka discloses each of the required components and amounts, and for the same purpose of a method of treating pulmonary disease [0262].
Further, one having ordinary still in the art would reasonably expect success in combining prior art elements according to known methods to yield predictable results, see MPEP 2141.
The Supreme Court has acknowledged:
When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one. If a person of ordinary skill can implement a predictable variation... 103 likely bars its patentability...if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond that person’s skill. A court must ask whether the improvement is more than the predictable use of prior-art elements according to their established functions......the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results (see KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 U.S. 2007) (emphasis added).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
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/QUANGLONG N TRUONG/Examiner, Art Unit 1615
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