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 .
Election/Restrictions
Applicant's election with traverse of group I and species of claims 110,114 and 117 in the reply filed on 12/22/25 is acknowledged. The traversal is on the ground(s) that Chiosis is silent about condensates as recited in the pending claims. Nowhere does Chiosis provide evidence that Hsp90 forms a condensate. This is not found persuasive because the Hsp90 of Chiosis et al. inherently forms dynamic condensates, as evidenced by Hu et al. (Chem Sci. 2024, 15, 10508). The proteins in cell lysates that preferentially integrate into Hsp90α condensates can be determined via LC-MS/MS (abstract) and Chiosis et al. discloses the examination of Hsp90α inhibition in cell lysates (p8, [0100]; claim 2), thereby showing that a condensate is present.
Products of identical chemical composition can not have mutually exclusive properties. A chemical composition and its properties are inseparable. Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable and does not render the old composition patentably new to the discoverer. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
The requirement is still deemed proper and is therefore made FINAL.
Claims 111,113,115,116 and 120-123 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected groups and species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 12/22/25.
Claim Rejections - 35 USC § 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 (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 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.
Claim(s) 106-110,112,114,117-119,126 and 127 and is/are rejected under 35 U.S.C. 103 as being unpatentable over Chiosis et al. (US 2007/0178537A1) as evidenced by Hu et al. (Chem Sci. 2024, 15, 10508) and further evidenced by Sun et al. (J. Cell Science (2020), 133, p1-17).
Chiosis et al. (US 2007/0178537A1) discloses a method for identifying candidate molecules as inhibitors of Hsp90 (abstract; p1, [0009]; p3, [0044]) that encompasses the method of characterizing a first agent of the instant claims.
The method for identifying candidate molecules utilizes a composition comprising a fluorescently-labeled Hsp90 binding agent/molecule, Hsp90α and a candidate molecule (claims 1 and 10).
The candidate molecule has activity as an inhibitor of Hsp90 (abstract; p3, [0044]) and encompasses the first agent of the instant claims.
The fluorescently-labeled molecule/compound comprises a binding moiety and a fluorescent
moiety (abstract; p1, [0009]; claim 24) that encompasses the second agent of the instant claims.
The Hsp90α is a condensate, as evidenced by Hu et al. (Chem Sci. 2024, 15, 10508) that teaches Hsp90α inherently forms dynamic condensates. The proteins in cell lysates that preferentially integrate into Hsp90α condensates can be determined via LC-MS/MS (abstract) and Chiosis et al. discloses the examination of Hsp90α inhibition in cell lysates (p8, [0100]; claim 2), thereby predictably showing that a condensate is present.
Products of identical chemical composition can not have mutually exclusive properties. A chemical composition and its properties are inseparable. Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable and does not render the old composition patentably new to the discoverer. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
Chiosis et al. further discloses that fluorescent moiety comprises FITC, BODIPY, etc. (p7, [0087]) that encompasses the fluorescent detectable tag, such as FITC, BODIPY (spec, [0363],[0309]) of the instant claims 107 and 108.
The FITC and BODIPY encompasses the fluorescent detectable tag, such as FITC, BODIPY (spec, [0363],[0309]) of the instant claim and are usable with fluorescent microscopy.
The binding moiety of the fluorescently-labeled molecule/compound binds to Hsp90 in the ATP/ADP binding pocket (p1, [0011]; p6, [0087]) wherein the ATP/ADP binding pocket encompasses the condensate comprises a target component for the second agent of the instant claim 110.
The Hsp90 ATP/ADP binding pocket encompasses the component of the condensate is a receptor of the instant claims 126 as it is a receptor for ATP.
The method for identifying candidate molecules uses fluorescence polarization (FP) assay to measure the degree of FP (abstract) and when the fluorescently-labeled molecule/compound is bound to the Hsp90, the emission is substantially polarized (p3, [0048]).
The fluorescently-labeled molecule/compound is wholly or partially displaced by the candidate molecule as is indicated by decrease in the degree of polarization resulting from the unbound fluorescently labeled species (abstract; p1, [0009]; p3, [0048]; p7, [0094]; claim 32) that encompasses the first agent has a higher affinity for the component of the condensate than the second agent of the instant claims.
The wholly or partially displaced fluorescently-labeled molecule/compound by the candidate
molecule encompasses the ability of the first agent to cause eviction of the second agent from the
condensate is measured of the instant claim 117.
The candidate molecules and the fluorescently-labeled molecule/compound comprise geldanamycin (GM) and GM-BODIPY, respectively (p7, [0087]; p8, [0096]) wherein the GM does not
exclude isomers of the instant claim 112.
The GM and GM of the GM-BODIPY probe encompass the first agent and second agent have similar structure and are small molecules of the instant claims
The FP assay uses cellular lysates (p8, [0100]) that encompasses the condensate does not comprise a cell of the instant claim 114.
Suitable fluorescently-labeled molecules/compounds known to bind Hsp90 include molecules that incorporate a fluorescent label without interfering with the bonding of the candidate molecule to Hsp90 (p3, [0050] that encompasses the detectable tag does not affect the condensate partition
property of the first agent and/or second agent of the instant claim 109.
The real time biochemical studies using an FP assay comprise varying amounts of inhibitors (candidate molecules) and reading the polarization signal (p9, Example 10) that encompasses the composition is contacted with increasing amounts of the first agent, and the eviction of the second agent from the condensate is measured at a discrete interval of the instant claims.
Chiosis et al. does not explicitly disclose that the condensate is a transcriptional condensate, a super-enhancer condensate or a heterochromatin condensate of the instant claim 127.
Chiosis et al. further discloses that Hsp90 chaperone machinery was found to be required for
the correct conformation, function and stability of several kinases, hormone receptors and transcription factors (p2, [0040]; p6, [0086]).
Also, the Hsp90 encompasses the condensate of the instant claims, has the same properties and is capable of the same functions, such as being a heterochromatic condensate of the instant claim 127, as evidenced by Sun et al. (J. Cell Science (2020), 133, p1-17) that teaches the molecule chaperone Hsp90 regulates heterochromatin assembly (title; p2, left column, second paragraph; p5, Hsp90 is required for the assembly of heterochromatin across major heterochromatic domains).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to perform the same method as instantly claimed since the prior art teaches the steps encompassed by the instant claims. Note, that the Hsp90 condensate in the cell lysates of Chiosis et al. is a heterochromatin condensate as the Hsp90 predictably assists with protein folding and function of heterochromatin assembly.
Products of identical chemical composition can not have mutually exclusive properties. A chemical composition and its properties are inseparable. Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable and does not render the old composition patentably new to the discoverer. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
Conclusion
No claims are allowed at this time.
Any inquiry concerning this communication or earlier communications from the examiner
should be directed to MELISSA JEAN PERREIRA whose telephone number is (571)272-1354. The
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/MELISSA J PERREIRA/ Examiner, Art Unit 1618