Status of the Claims
Claims 1-2, 4-7, 11, 15-18, 20, 32-36, 39, and 41-44 are pending and examined herein.
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.
Claims 4 and 33 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 4 recites the limitation “the vessel”. There is insufficient antecedent basis for this limitation. This rejection may be overcome by providing proper antecedent basis or changing the dependence of the claim. Other solutions are possible.
Regarding claims 4 and 33, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. Specifically regarding claim 33, the term “including” is similarly indefinite. See MPEP § 2173.05(d). For the purposes of examination, both of “such as” and “including” will be interpreted as not further limiting the invention.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Zhang et al.
Claims 1, 5, 11, 15, 17-18, 20, 32-33, 35-36, 39, and 42 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhang et al. (Anal. Chem. (2020), 92: 1363-1371; cited in IDS of 06/06/2024).
Regarding claims 1, 11, 17, 18, 20, 32, 33, 35-36, 39, and 42, Zhang discloses a method of identifying whether kinases and staurosporine (p. 1364, col. 1, 2nd ¶) bind to one another, the method comprising: exposing the protein target to 100 μM of the compound for 20 minutes; contacting the protein target with a solvent mixture of acetone/ethanol/acetic acid for 20 min at 37°C (p. 1364, Preparation of Cell Extract for Stabilization Profiling); and assaying the folded products of the denaturing mixture by Western blot or mass spectrometry (p. 1365, Liquid Chromatography-Tandem Mass Spectrometry Analysis; Target Validation with Western Blotting) to determine the proportion of the protein target in its folded state; wherein a change in the proportion of protein in its folded state as compared to a suitable control indicates that the target and compound bind to one another (p. 1364, col. 1, 2nd ¶; p. 1365, col. 2, last ¶).
Regarding claim 5, Zhang further discloses that step i) occurs at room temperature (p. 1364, Preparation…) and step iii) (LC-MS) was performed at 275°C (p. 1365, Liquid…).
Mahendrarajah et al.
Claims 1-2, 4, 6, 11, 15, 34-36, 39, and 42 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mahendrarajah et al. (Anal. Biochem. (2011), 411: 155-157).
Regarding claims 1, 6, 11, 34-36, 39, and 42, Mahendrarajah discloses a method of identifying whether rapamycin analogs bind to FKBP12, comprising: exposing 24 ng/μL of FKBP12 (p. S2, 1st ¶: “2 μM protein”; 12 kDa protein at 2 μM ≅ 24 ng/μL) to 10-15 μM rapamycin analog (p. S2, 1st ¶) for a sufficient time to allow binding; contacting the protein target with GuHCl at 25°C for 24 hours (p. S2: “pre-equilibrated at 25°C for approximately 24 hours”) to produce a denaturing mixture (Fig. 1G); assaying the products at 25°C (p. S1, Fluorimeter Measurements) to determine the proportion of the protein in its denatured state (Fig. 1G: “Fraction unfolded”); wherein a change in the proportion of protein in its denatured state compared to a suitable control indicates that the protein target and compound bind to one another (p. 156, col. 1: “the midpoint of each curve… reflects the strength of ligand binding”).
Regarding claims 2, 4, and 15, Mahendrarajah further discloses that steps ii) and iii) are conducted in a 96-well plate and the assaying is carried out directly upon the denaturing mixture (p. S1-2, Preparation of samples for Fluorescence Plate Reader Experiments).
Tan
Claims 1, 11, 16, 41, and 43-44 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Tan (US 2024/0302379; priority date: 12/24/2020).
Regarding claims 1, 11, 16, 41, and 43-44, Tan discloses a method (UCEP-Screen) of identifying whether a protein target (p. 8, ¶[0112]: Flp recombinase) and a compound of interest bind to one another, comprising: exposing the target to the compound for a time sufficient to allow binding (p. 8, ¶[0113]); contacting the target with urea to produce a denaturing mixture (p. 8, ¶[0113]) at 37°C (p. 7, ¶[0103]); and assaying the products of the denaturing mixture using a HiBiT assay (p. 8, ¶[0113]) to determine the proportion of the target and an associated protein in a folded state, wherein a change of the proportion indicates that the protein target and compound of interest bind to each other (p. 8, ¶[0113]).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Mahendrarajah et al.
Claims 5 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Mahendrarajah et al. Mahendrarajah discloses all limitations of claim 1, as discussed previously. Mahendrarajah does not disclose the temperature at which the ligand-protein complex is formed and therefore does not explicitly disclose that steps i), ii), and iii) take place at the same substantially constant temperature. However, according to MPEP 2144.05(II), differences in temperature are generally considered to by prima facie obvious as they typically represent routine optimization. In the instant case, it would therefore have been obvious to carry out the ligand-protein complex equilibration at room temperature, rendering obvious claims 5 and 7.
Conclusion
No claims are allowed.
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/ALEXANDRA OLSON/Examiner, Art Unit 1684
/JEREMY C FLINDERS/Primary Examiner, Art Unit 1684
