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 .
Status of the Application
Claims 37-39, 41, 48, 54, 62 and 92-102 are pending as of the response filed 07/09/2026. Claims 1-36, 40, 42-47, 49-53, 55-61 and 63-91 are cancelled. Claims 92-102 are newly added. Claims 41, 48, 54 and 62 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 37-39 and 92-102 are examined herein.
The objection to the specification of previous record is withdrawn in consideration of the amendments to the specification.
The 35 U.S.C. 112(b) rejection of previous record is either rendered moot in consideration of the cancellation of the claims or withdrawn in consideration of the claim amendments.
The 35 U.S.C. 102 rejection of previous record over Ponder is withdrawn in consideration of the claim amendments.
Applicant’s remarks have been carefully considered. Applicant’s indication of unexpected results in pages 28-33 of the remarks dated 07/09/2026, was found to be persuasive. Specifically, Applicant’s discussion stating that the claimed homolog shows a 237-fold improvement in anti- leukemic activity in comparison to compound BSK-187 of Ponder in anti-leukemic assay (Table 2, Para. [00399]); wherein compound BSK-140 of Ponder shows a more than 26-fold improvement in GSK-3β inhibition in comparison to the instantly claimed BSK-230 (Table 1, Para. [00377]); superior cytotoxicity of the instantly claimed compounds across different cancer cell lines, with superior GI50 values of BSK-259, BSK-226 and BSK-230 in comparison to BSK-140 and BSK-187 against human leukemia cell lines (Table 4, Paras. [00401]-[00403]), was found to be persuasive. The 35 U.S.C. 103 rejection of previous record over Ponder is hereby withdrawn.
Applicant’s representative, Attorney Zimmerman, was contacted in an effort to move prosecution forward. However, because a valid power of attorney could not be timely obtained, it was mutually determined that issuing an Office action on the merits is the appropriate next step.
In view of the pending claims, the following objections/rejections are made necessitated by the claim amendments.
Claim Objections
Claim 37 is objected to because of the following informalities:
In claim 37, the following structure within the definition of the R11 variable appears to have been inadvertently entered incorrectly (with a double bond between the two keto groups).
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It is suggested that the above structure be replaced by the following structure, as was previously presented in the claim set dated 02/04/2026.
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Appropriate correction is required.
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.
Claim 94 is 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.
Regarding claim 94, the claim depends from claim 93 and recites “… wherein Cy1, when present, is unsubstituted C6 aryl”. However, claim 93 requires R1 to be Cy1, introducing ambiguity regarding the scope of the claim. Therefore, the metes and bounds of the claim are indefinite.
For the purpose of applying prior art, claim 94 has been interpreted to read “wherein Cy1 is unsubstituted C6 aryl or C6 aryl monosubstituted with a group selected from halogen, -CN, and C1-C4 alkoxy[[ or wherein Cy¹, when present, is unsubstituted C6 aryl]]”.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 38 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Regarding claim 38, the claim depends from claim 37 and recites the following compound (Pg. 11 of the claim set dated 07/09/2026).
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However, the R11 group of this compound is not supported by claim 37 (see claim objection above). This broadens the scope of claim 38, which is improper.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
The examiner notes that amending as suggested in the claim objection will overcome this rejection.
Allowable Subject Matter
Except for the claim objection, 35 U.S.C. 112(b) and 35 U.S.C. 112(d) rejections above, claims 37-39 and 92-102, would be allowable. Claims 38-39 and 92-102 are objected to as being dependent from an objected base claim.
The following is a statement of reasons for the indication of allowable subject matter:
The instant claims are drawn to a compound having a structure represented by a formula as in claim 37 with variables as defined in instant claim 37, a pharmaceutical composition thereof.
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The closest prior art is Ponder, Dissertation (Phenotypic Screening of Parthenolide Derivatives reveals the Chemotherapeutic Role of Galectin-1 in Acute Myeloid Leukemia, 18 May 2018, in the IDS) and Flynn et al. (US 2007/0191336 A1, 16 August 2007, hereinafter Flynn).
Ponder teaches compound BSK 1-40 (EC50 of 1.3 uM) and BSK 1-87 (EC50 of 1.2 uM) as a potent thiadiazolidinone (TDZD) analogues of chemotherapeutic agents (Pg. 199, Batch 23.2; Pg. 203, Batch 25.1b) having efficacy against acute myeloid leukemia (AML) cell lines (Abstract). BSK 1-40 and BSK 1-87 have the following structure (Pg. 199, first compound; Pg. 203, first compound of second column).
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However, the instant claims exclude these compounds. And, Applicant’s show unexpected results for the closest homologs (differing in the addition of a single methylene group) in comparison to the above compounds (as discussed in pages 28-33 of the remarks dated 07/09/2026), rendering the instant compounds non-obvious.
Flynn teaches novel compounds that modulate p38 kinases for the treatment of inflammatory conditions (Abstract). Flynn teaches the following compound of example 288 (Para. [0816]).
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The compound of example 288 of Flynn overlaps the scope of the formula of instant claim 37, wherein R1 is Cy1, Cy1 is aryl (phenyl). The compound of example 288 of Flynn does not satisfy the requirement of R2c of the instant claims.
Therefore, the instant compounds are novel and non-obvious variants of the compounds taught in the prior art.
Miscellaneous
The examiner would like to bring Applicant’s attention to the following:
A power of attorney document is not present in the application file.
Conclusion
Claims 38 and 94 are rejected.
Claims 37-39 and 92-102 are objected to.
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PADMAJA S RAO whose telephone number is (571)272-9918. The examiner can normally be reached 9:00-5:30pm EDT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney L Klinkel can be reached on (571) 270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PADMAJA S RAO/Examiner, Art Unit 1627
/Kortney L. Klinkel/Supervisory Patent Examiner, Art Unit 1627
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