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
Election of Species and Status of the Claims
Applicant’s election without traverse of ‘compound 1001’ as the single specific compound and ‘asthma’ as the single specific disease/disorder/condition in the response filed on April 16th 2026 is acknowledged. Claims 1-3, 6, 9, 11, 17, 19, 21, 28, 30, 32, 34-39, and 42 are pending. Claims 30 and 37-38 are withdrawn from further consideration as being directed towards nonelected species until a generic claim has been found allowable (note that claim 30 explicitly removes compound 1001). Claims 1-3, 6, 9, 11, 17, 19, 21, 28, 32, 34-36, 39, and 42 are examined on their merits.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 120 is acknowledged. Applicant has complied with all conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 based on the date of the provisional application 63/378,777 filed on October 7th 2022.
Information Disclosure Statement
The Information Disclosure Statement filed on August 27th 2024 is in compliance with the provisions of 37 CFR 1.97 and has been considered in full. A signed copy of references cited from the IDS is included with this Office Action.
Claim Rejections - 35 USC § 112(b)
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 32, 34, 39, and 42 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 32 and its dependent claims 34, 39, and 42 are indefinite for reciting “a disease or disorder alleviated by allosterically modulating β2 adrenoreceptor,” because one of ordinary skill in the art could not reasonably determine the metes and bounds of the diseases/disorders encompassed by the phrase. The extend of the guidance provided by the applicant to the breadth of the diseases covered by this term is in paragraph [209]-[210], which recite:
In one embodiment, the method of treating a disease or disorder comprises allosterically activating β2-adrenoceptor. In some embodiments, the disease or disorder is an inflammatory disease. In some embodiments, the inflammatory disease is selected from the group consisting of rheumatoid arthritis, a cardiovascular disease, multiple sclerosis, inflammatory bowel disease, chronic obstructive pulmonary disease (COPD), asthma, acute respiratory distress syndrome (ARDS), and acute lung injury (ALI). In some embodiments, the inflammatory disease is asthma or COPD.
In one embodiment, the method of treating a disease or disorder comprises allosterically inhibiting β2-adrenoceptor. In some embodiments, the disease or disorder is a cardiovascular disease. In some embodiments, the cardiovascular disease is selected from the group consisting of coronary obstructions, coronary artery disease (CAD), angina, heart attack, cardiac arrhythmia, cardiomyopathy, myocardial infarction, cardiac failure, high blood pressure, heart valve disease, and heart failure. Non-limiting examples of cardiomyopathy include ischemic cardiomyopathy, dilated cardiomyopathy, restrictive cardiomyopathy, and hypertrophic cardiomyopathy. Non-limiting examples of heart failure include chronic heart failure; acute decompensated heart failure; high-output heart failure; left-sided heart failure; right-sided heart failure; biventricular heart failure; heart failure due to reduced ejection fraction (HFrEF), also referred to as “systolic heart failure;” heart failure with preserved ejection fraction (HFpEF), also referred to as “diastolic heart failure;” and congestive failure. In some embodiments, the cardiovascular disease is cardiomyopathy or heart failure. In some embodiments, the cardiovascular disease is cardiomyopathy. In some embodiments, the cardiovascular disease is heart failure. In some embodiments, the cardiovascular disease is congestive heart failure.
Applicant has defined several of the diseases encompassed by the phrase, such as the respiratory, inflammatory and cardiac disorders described above, but has not provided any guidance as to the full extent of diseases and disorders included.
Furthermore, the phrase, “a disease or disorder alleviated by allosterically modulating β2 adrenoreceptor,” does not provide any objective criteria for determining which diseases are alleviated by the described activity. See MPEP § 2173.02(I):
Patented claims are not given the broadest reasonable interpretation during court proceedings involving infringement and validity, and can be interpreted based on a fully developed prosecution record. While "absolute precision is unattainable" in patented claims, the definiteness requirement "mandates clarity." Nautilus, Inc. v. Biosig Instruments, Inc., 572 U.S. 898, 910, 110 USPQ2d 1688, 1693 (2014). A court will not find a patented claim indefinite unless the claim interpreted in light of the specification and the prosecution history fails to "inform those skilled in the art about the scope of the invention with reasonable certainty." Id. at 899, 110 USPQ2d at 1689.
Claim 34 is indefinite for the phrase, “wherein the method further comprises allosterically activating β2 adrenoreceptor,” because one of ordinary skill in the art could not reasonably determine how the phrase further limits the method of claim 32.
The method of claim 32 is defined by:
The patient population receiving administration of the compound.
The compound being administered.
Particular aspects of the administration (i.e. dosage, delivery route, etc.).
None of these details are described by the method, but only the method’s correlation to particular biological activity (i.e. observations of a result). Furthermore, even if one of ordinary skill in the art were to assume that the phrase was intended to limit the compound administered, it is unclear as to how the compound would need to be limited in order to achieve the described activity. Applicant has demonstrated that a series of compounds do achieve such activity through various assays (see Figures 7A, 7B). However, applicant has not described definitive structural moieties that must be present in order to achieve such activity, nor an objective standard as to what compounds would qualify as a β2 adrenoreceptor activator (for example, a potency threshold defined by a minimum fold-shift in EC50).
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.
Claims 1-3, 6, 9, 11, 19, 21, and 28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bonnett (Bonnett et al., ACS Infectious Diseases 2016 2 (12), 893-902).
Claims 1-3, 6, 9, 11, 19, 21, and 28 are directed towards a compound of formula (I):
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.
One such compound is compound 1003:
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.
Compound 1003 is taught by Bonnett (Bonnett, pg. 897, Table 2, Compound 4). Bonnett thereby anticipates claims 1-3, 6, 9, 11, 19, 21, and 28.
Claims 1-3, 6, 11, 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hwang (WO 2010/011349 A2 published on January 28th 2010).
Hwang teaches the compound,
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(Hwang, pg. 34).
Hwang’s compound is anticipatory of claims 1-3, 6, 11, and 17.
Claims 1-3, 32, 35, 36, and 42 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Regnier (U.S. Patent No. 3,585,193 issued on June 15th 1971).
Regnier teaches the compound,
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(Regnier, col. 4, Example 3, compound (c)).
Regnier’s compound is anticipatory of claims 1-3.
Claims 32, 35, and 36 are directed towards the treatment of asthma with the compound of claim 1. Regnier teaches the treatment of bronchial asthma with the compound (Regnier, col. 2, lines 40-44), anticipating claims 32, 35, and 36.
Claim 42 requires that, in the method of claim 32, the compound is administered in a dosage unit form. Regnier teaches administration in various dosages of the compound (Regnier, col. 2, lines 45-53), anticipating claim 42.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anthony Seitz whose telephone number is (703)756-4657. The examiner can normally be reached 7:30 AM ET - 5:00 PM ET M-F.
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/ANTHONY JOSEPH SEITZ/Examiner, Art Unit 1629
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