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 .
Request for Continued Examination
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on March 5th 2026 has been entered.
Priority
Acknowledgement is made of Applicant’s claim for benefit under 35 U.S.C. §119(e) to
United States Provisional Patent Application Serial No. 62/332,919, filed April 20, 2022.
Status of the Claims
Claims 1-23 are pending in the present application. Applicant’s amendment to Claims 12 and 17 in response to the Office Action filed on December 5th 2025 is acknowledged. Claims 1-11 and 22 have been withdrawn. Claims 12-21 and 23 are examined on their merits and are the subject of the Office Action below.
Response to Applicants Arguments under 35 U.S.C. § 112
Applicant argues claims 17-19 were rejected under 35 U.S.C. § 112 for allegedly for failing to include all the limitations of the claim upon which it depends because they don't incorporate all of the limitations of claim 12 (variable X). Without acquiescing to or otherwise commenting on the merits of the rejection, Applicant has amended the claims in the interest of advancing prosecution.
35 USC § 112 Rejections Overcome by Amendment
Applicant has amended claim 12 to define the X variable as -CONH- or -SO2N- which now defines the functional groups that are identified as variable X that includes an amide, sulfonamide, carbonyl and sulfonyl bonds. The variable X is no longer limiting claims 17-19 as an improper dependent form and now includes all the limitations of the claim upon which it depends. The rejection of claims 17-19 have thereby been withdrawn.
35 USC § 101 Rejection Maintained
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
The rejection of the claims 12-21 and 23 under 35 U.S.C. 101 is maintained because the claimed invention is not directed to patent eligible subject matter. Based upon an analysis with respect to the claims as a whole, claim(s) 12-21 and 23 do not recite something significantly different than a judicial exception.
Response to Applicants Arguments under 35 U.S.C. § 101
Applicant argues claims 12-21 and 23 are directed to inhibiting Polo-like Kinase proteins by providing a small molecule to a medium containing one or more Polo-like Kinase proteins, wherein the small molecule is a PLK inhibitor without significantly more is not being directed to a judicial exception. Applicant has amended independent claim 12 to be directed to a method for inhibiting Polo-like Kinase proteins activity in a medium the method comprising, inter alia, contacting the medium containing one or more Polo-like Kinase proteins with a small molecule PLK inhibitor. The substance of the amended claim 12 now cites a method for inhibiting Polo-like Kinase proteins activity in a medium, the method comprising: contacting the medium containing one or more Polo-like Kinase proteins with a small molecule PLK inhibitor, wherein the small molecule PLK inhibitor has the general structure of (I); the same genus as identified in claim 12 before the amendment. The only substantive change to claim 12 in addition to separating the variables R3-R8 into groups consisting of R3 and R4, R5 and R6-R8 is the change in the method claim as underlined above rather than a method for inhibiting Polo-like Kinase proteins the method comprising: providing a small molecule PLK inhibitor to medium containing one or more Polo-like Kinase proteins, wherein the small molecule PLK inhibitor has the general structure of the same genus of structure of (I).
35 USC § 101 Rejections Reiterated
As detailed in the Office Action dated June 25th 2025, the claimed invention is directed to an abstract idea. The claims 12-21 and 23 are directed to inhibiting Polo-like Kinase proteins by providing a small molecule to a medium containing one or more Polo-like Kinase proteins, wherein the small molecule is a PLK inhibitor without significantly more.
Claims 12-21 and 23 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more. The claims recite a method for inhibiting Polo-like Kinase proteins activity in a medium, comprising: contacting the medium containing one or more Polo-like Kinase proteins with a small molecule PLK inhibitor of the compound (I). This judicial exception is not integrated into a practical application because the claims recite merely the contact of a particular type of cell with a compound (i.e. a natural phenomenon) and the results of said contact (inhibiting Polo-like Kinase proteins activity). The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because only the natural phenomenon and the result of said natural phenomenon are recited.
35 USC § 102 Rejections Maintained
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 12, 13, 14, 15, 17-20 and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by United States Patent Application Publication US 2017/0283445 Al, published Oct. 5, 2017 hereinafter referred to as 445.
Response to Applicants Arguments
Applicant argues the Office Action fails to establish that '445 teaches each and every limitation of the claimed invention. For instance, '445 fails to disclose a small
molecule PLK inhibitor of Formula (I) including all of the variables included in R1-R8 that can be hydrogen, but include other possible substitutions are included in each of the variable positions. If ‘445 taught each and every limitation of the claimed invention the examiner would have made a double-patenting objection to the instant application because they share a common assignee and inventor.
‘445 does anticipate the small molecule PLK inhibitors that can target the polo box domain and have a mass of 1000 Da or less. For example,
‘445 Compound [0049]
Compound (I) instant application
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248
397
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502
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R1 comprises an alkyl, -0-alkyl, -S-alkyl, or -NH-alkyl, and optionally includes a terminal aryl;
R2 through R6 are independently selected from
hydrogen,
X is an amide, -Cl to C4 alkyl-NH-,
-NH-, -SNH-, ----SONH-, or -SO2N-.
R1 comprises a hydrogen, -Cl to C8 alkyl, -Cl to C8 alkoxy, or -OH;
R2-R6 can be independently selected from hydrogen
X is -CONH- or -SO2N-
n=0
35 USC § 102 (a)(1) Rejections Reiterated
Although ‘445 does not allow a hydrogen to be substituted for the R1 variable, all of the other variables identified in claim 12 from R1-R8 can be hydrogen. Therefore, ‘445 anticipates the compound of claim 12.
The applicant has not amended any claims other than claim 12 and 17 (removing select previously presented compounds) , therefore the rejections to claims 13, 14, 15, 17-20 and 21 are maintained.
35 U.S.C. § 103 Rejections Maintained
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.
Claim16 is rejected under 35 U.S.C. 103 as being unpatentable over 445 and further in view of Teicher et.al. Cancer Res, Volume 77, (Issue 13_Supplement): 348, 2017 hereinafter referred to as Teicher is maintained.
Response to Applicants Arguments
Applicant points to remarks made previously and also notes that the patentability of the dependent claims certainly does not hinge on the patentability of independent claims. Some or all of these claims may possess features that are independently patentable, regardless of the patentability of the independent claims.
35 USC § 103 Rejection Reiterated
445 discloses that PLK inhibitors are used to treat a number of cancers including prostate, lung and colon cancer because the PLK is overexpressed in most cancers. Further, that the cancer cell lines are maintained in a medium that is a solution as described in the rejection above. Teicher teaches the specific cell lines were tested with small molecules including Polo-like kinase-1 inhibitors and that those cell lines include HOP-92, A549, EKVX, NCI-H226 and NCI-H23 of the instant claim.
Claim 16 is directed to evaluating a PLK inhibitor administered to cancer cell lines to determine the effectiveness of the compound. The method of testing a PLK inhibitor on cancer cell lines is taught by ‘455 and the specific cancer cell lines as taught by Teicher is prima facie obvious.
35 U.S.C. § 112(a) New Matter Rejection
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 12 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Applicant’s amendment to claim 12 filed March 5th 2026 is acknowledged. Applicant has amended claim in two distinct ways. First, applicant added a variable to R2 is that independently selected from hydrogen, (Cl to C8) alkyl, (Cl to C8) alkoxy, secondary (Cl to C8) alkyl methylamine (C8N(Me)), -CONH-(Cl to C6 alkyl), -C9H9ClNOS, (Cl to C9 alkyl)-sulfinyl amino chloride, or NH2, that is new (underlined) and that is not supported in the specification. The applicant has further added a proviso that requires:
“wherein when R2 is (Cl to C8) alkyl or (Cl to C8) alkoxy, then R5 is independently selected from CF3, a hydrogen, or a methyl and/or R4, is independently selected from hydrogen, alkyl phosphonate, phosphonate, alkyl phosphonate monoester, alkyl phosphonate disopropylester, or phosphate di-t-butylester.”
Claim 12 contains two distinct amendments to the claim that limit R2, to include C9H9ClNOS and added a proviso, cited above, these limitations are considered as new matter because they are not recited in the specification.
Conclusion
Claims 12-21 and 23 are rejected.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL RANDALL GAUGER whose telephone number is (571)272-1325. The examiner can normally be reached M-F 7:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffery Lundgren can be reached at (571)272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/P.R.G./Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
