DETAILED ACTION
Notice of Pre-AIA or AIA Status
The inventor or joint inventor should note that the instant invention, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claims 1-15, 18, 20-22 and 24 are pending in the instant invention. According to the Amendments to the Claims, filed June 18, 2026, claims 1, 18 and 20-22 were amended and claims 16, 17, 19, 23 and 25-52 were cancelled.
Status of Priority
This invention is a 35 U.S.C. § 371 National Stage Filing of International Application No. PCT/US2022/043054, filed September 9, 2022, which claims priority under 35 U.S.C. § 119(e) to US Provisional Application No. 63/242,427, filed September 9, 2021.
Restrictions / Election of Species
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The inventor’s or joint inventor’s provisional election of the following, without traverse, in the reply filed on June 18, 2026, is acknowledged: Group I - claims 1-15, 18, 20-22 and 24. Affirmation of this election must be made by the inventor or joint inventor in replying to this Office action.
Moreover, the inventor or joint inventor should further note that the requirement is still deemed proper and is therefore made FINAL.
Thus, a first Office action and prosecution on the merits of claims 1-15, 18, 20-22 and 24 is contained within.
Specification Objection - Disclosure
The inventor or joint inventor is advised to format the specification according to 37 CFR 1.77(c). Revisions should particularly address bold-type, underline, and/or upper case formatting. Appropriate correction may be required.
Specification Objection - Title
The inventor or joint inventor is reminded of the proper content of the title of the invention.
The title of the invention should be brief, but technically accurate and descriptive and should contain fewer than 500 characters. See 37 CFR 1.72(a) and MPEP § 606.
The title of the invention is not technically accurate and descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed. In the revised title, the examiner suggests additionally identifying 2-[(3R,5R,6S)-5-(3-chlorophenyl)-6-(4-chlorophenyl)-3-methyl-1-[(2S)-3-methyl-1-(propane-2-sulfonyl)butan-2-yl]-2-oxopiperidin-3-yl]acetic acid of the formula (I).
The following title is suggested: METHOD FOR TREATING A CANCER OVEREXPRESSING ONE OR MORE BCL-2 FAMILY PROTEINS COMPRISING ADMINISTERING 2-[(3R,5R,6S)-5-(3-CHLOROPHENYL)-6-(4-CHLOROPHENYL)-3-METHYL-1-[(2S)-3-METHYL-1-(PROPANE-2-SULFONYL)BUTAN-2-YL]-2-OXOPIPERIDIN-3-YL]ACETIC ACID.
Appropriate correction is required.
Specification Objection - Abstract
The inventor or joint inventor is reminded of the proper content of an abstract of the disclosure.
With regard particularly to chemical patents, for compounds or compositions, the general nature of the compound or composition should be given as well as the use thereof, e.g., The compounds are of the class of alkyl benzene sulfonyl ureas, useful as oral anti-diabetics. Exemplification of a species could be illustrative of members of the class. For processes, the reactions, reagents and process conditions should be stated, generally illustrated by a single example, unless variations are necessary. See MPEP § 608.01(b), Section B.
The abstract of the disclosure is objected to because it fails to exemplify any members or formulae illustrative of its class. Correction is required. See MPEP § 608.01(b).
The examiner suggests incorporating the 2-[(3R,5R,6S)-5-(3-chlorophenyl)-6-(4-chloro-phenyl)-3-methyl-1-[(2S)-3-methyl-1-(propane-2-sulfonyl)butan-2-yl]-2-oxopiperidin-3-yl]acetic acid of the formula (I) into the abstract, to overcome this objection.
Claim Objections
Claim 1 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
A method for treating a cancer in a human subject, wherein the method comprises administering to the human subject in need thereof a therapeutically effective amount of a compound of Formula (I):
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(I)
or a pharmaceutically acceptable salt thereof;
wherein the therapeutically effective amount of the compound of Formula (I) is administered to the human subject in need thereof on days 1 through 7, followed by no administration of the compound of Formula (I) on days 8 through 28 of a 28-day cycle;
wherein the cancer overexpresses at least one B-cell lymphoma 2 (Bcl-2) anti-apoptotic/pro-survival family protein in the human subject;
wherein the human subject has a wild-type p53 gene; and
wherein at least one Bcl-2 anti-apoptotic/pro-survival family protein is selected from the group consisting of Bcl-B, Bcl-W, Bcl-XL, Bcl-2, Bfl-1/A1, and Mcl-1.
Appropriate correction is required. See MPEP § 2173.02.
Claim 2 is objected to because of the following informalities: for clarity, the claim is dependent upon an objected base claim. Appropriate correction is required. See MPEP § 2173.02.
Claim 3 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
The method of claim 1, wherein the cancer is selected from the group consisting of acute myeloid leukemia, Burkitt’s lymphoma, diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL), Merkel cell carcinoma, metastatic prostate cancer, myelofibrosis, small cell lung cancer (SCLC), and T-cell lymphoma.
Appropriate correction is required. See MPEP § 2173.02.
Claim 4 is objected to because of the following informalities: for clarity, the claim is dependent upon an objected base claim. Appropriate correction is required. See MPEP § 2173.02.
Claim 5 is objected to because of the following informalities: for clarity, the claim is dependent upon an objected base claim. Appropriate correction is required. See MPEP § 2173.02.
Claim 6 is objected to because of the following informalities: for clarity, the claim is dependent upon an objected base claim. Appropriate correction is required. See MPEP § 2173.02.
Claim 7 is objected to because of the following informalities: for clarity, the claim is dependent upon an objected base claim. Appropriate correction is required. See MPEP § 2173.02.
Claim 8 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
The method of claim 7, wherein the B-cell hetological malignancy is selected from the group consisting of B-cell acute lymphoblastic leukemia (B-ALL), Burkitt’s lymphoma, chronic lymphocytic leukemia (CLL), diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), Hodgkin’s lymphoma, mantle cell lymphoma (MCL), non-Hodtgkin’s lymphoma (NHL), small lymphocytic leukemia (SLL), and T-cell Waldenström’s macroglobulinemia (WM).
Appropriate correction is required. See MPEP § 2173.02.
Claim 9 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
The method of claim 1, wherein the human subject is treated with immunotherapy prior to administering a therapeutically effective amount of the compound of Formula (I).
Appropriate correction is required. See MPEP § 2173.02.
Claim 10 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
The method of claim 9, wherein the immunotherapy is an ex vivo cell therapy selected from the group consisting of a chimeric antigen receptor (CAR)-engineered peripheral blood lymphocyte (PBL), a T-cell receptor (TCR)-engineered peripheral blood lymphocyte (PBL), and a tumor infiltrating lymphocyte (TIL).
Appropriate correction is required. See MPEP § 2173.02.
Claim 11 is objected to because of the following informalities: for brevity, clarity and precision, the existing recitation should be replaced with the following recitation:
The method of claim 9, wherein the immunotherapy is an immune checkpoint protein inhibitor.
Appropriate correction is required. See MPEP § 2173.02.
Claim 12 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b), the existing recitation should be replaced with the following recitation:
The method of claim 11, wherein the immune checkpoint protein inhibitor is an anti-programmed death-ligand 1 (PD-L1) antibody selected from the group consisting of atezolizumab, avelumab, BMS-936559, durvalumab, MDX1105-01, MEDI4736, MPDL3280A, and MSB0010718C.
Appropriate correction is required. See MPEP § 2173.02.
Claim 13 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b), the existing recitation should be replaced with the following recitation:
The method of claim 11, wherein the immune checkpoint protein inhibitor is an anti-programmed death-ligand 1 (PD-L1) antibody selected from the group consisting of AMP-224, AMP-514, cemiplimab-rwlc, dostarlimab, nivolumab, PDR001, pembrolizumab, pidilizumab, and tislelizimab.
Appropriate correction is required. See MPEP § 2173.02.
Claim 14 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b), the existing recitation should be replaced with the following recitation:
The method of claim 11, wherein the immune checkpoint protein inhibitor is an anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA) antibody selected from the group consisting of ipilimumab and tremelimumab.
Appropriate correction is required. See MPEP § 2173.02.
Claim 15 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b), the existing recitation should be replaced with the following recitation:
The method of claim 9, wherein the immunotherapy is a T-cell engager selected from the group consisting of blinatumomab, catumaxomab, ektomun, ertumaxomab, FBTA05, and solitomab.
Appropriate correction is required. See MPEP § 2173.02.
Claim 18 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
The method of claim 1, wherein the method comprises administering to the human subject in need thereof a therapeutically effective amount of a pharmaceutically acceptable salt of the compound of Formula (I).
Appropriate correction is required. See MPEP § 2173.02.
Claim 20 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
The method of claim 1, wherein the method comprises once daily administering to the human subject in need thereof the compound of Formula (I), or a pharmaceutically acceptable salt thereof, at a dose selected from the group consisting of 15 mg, 25 mg, 30 mg, 50 mg, 60 mg, 75 mg, 90 mg, 100 mg, 120 mg, 150 mg, 175 mg, 180 mg, 200 mg, 225 mg, 240 mg, 250 mg, 275 mg, 300 mg, 325 mg, 350 mg, 360 mg, 375 mg, 420 mg, and 480 mg.
Appropriate correction is required. See MPEP § 2173.02.
Claim 21 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
The method of claim 1, wherein the method comprises twice daily administering to the human subject in need thereof the compound of Formula (I), or a pharmaceutically acceptable salt thereof, at a dose selected from the group consisting of 15 mg, 25 mg, 30 mg, 50 mg, 60 mg, 75 mg, 90 mg, 100 mg, 120 mg, 150 mg, 175 mg, 180 mg, 200 mg, 225 mg, 240 mg, 250 mg, 275 mg, 300 mg, 325 mg, 350 mg, 360 mg, 375 mg, 420 mg, and 480 mg.
Appropriate correction is required. See MPEP § 2173.02.
Claim 22 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
The method of claim 1, wherein the method comprises orally administering to the human subject in need thereof a therapeutically effective amount of the compound of Formula (I), or a pharmaceutically acceptable salt thereof.
Appropriate correction is required. See MPEP § 2173.02.
Claim 24 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
The method of claim 1, wherein the human subject has a Ki-67 protein proliferation rate of more than 10%.
Appropriate correction is required. See MPEP § 2173.02.
Claim Rejections - 35 U.S.C. § 112(d)
The following is a quotation of the fourth paragraph of 35 U.S.C. § 112:
(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.
Claim 12 is rejected under 35 U.S.C. § 112(d) 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.
The inventor or joint inventor should note that claim 2 recites the limitation, The method of claim 1, wherein the MDM2 inhibitor is administered again after day 21 for 7 days followed by no administration of the MDM2 inhibitor for 14 days, in lines 1-2 of the claim. According to claim 1, the MDM2 inhibitor is administered on days 1 through 7, followed by no administration of the MDM2 inhibitor on days 8 through 28 of a 28-day cycle, with respect to the method of treating a cancer in a human subject. Consequently, since The method of claim 1, wherein the MDM2 inhibitor is administered again after day 21 for 7 days followed by no administration of the MDM2 inhibitor for 14 days, fails to specify a further limitation to the method of treating a cancer in a human subject, as recited in claim 1, and/or fails to include all the limitations of the method of treating a cancer in a human subject, as recited in claim 1, the instant dependent claim is rendered improperly dependent under 35 U.S.C. § 112(d).
Similarly, the inventor or joint inventor should further note that the U.S. Court of Appeals for the Federal Circuit indicated that although the requirements of 35 U.S.C. § 112(d) are related to matters of form, non-compliance with 35 U.S.C. § 112(d) renders the claim unpatentable just as non-compliance with other subsections of 35 U.S.C. § 112 would. {See Pfizer, Inc. v. Ranbaxy Labs., Ltd., 457 F.3d 1284, 1291-92 (Fed. Cir. 2006)}.
Moreover, the inventor or joint inventor should further note that if a dependent claim does not comply with the requirements of 35 U.S.C. § 112(d) the dependent claim should be rejected under 35 U.S.C. § 112(d) as unpatentable rather than objecting to the claim. {See also MPEP § 608.01(n), Section III, Infringement Test for dependent claims}.
The examiner suggests the inventor or joint inventor (1) cancel the dependent claim, (2) amend the dependent claim to place the dependent claims in proper dependent form, (3) rewrite the dependent claim in independent form, or (4) present a sufficient showing that the dependent claim complies with the statutory requirements, to overcome this rejection.
Allowable Subject Matter
No claims are allowed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DOUGLAS M. WILLIS, whose telephone number is 571-270-5757. The examiner may normally be reached on Monday thru Thursday from 8:00-6:00 EST. The examiner is also available on alternate Fridays.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mr. Jeffrey Murray, may be reached on 571-272-9023. The fax phone number for the organization where this invention or proceeding is assigned is 571-273-8300.
Information regarding the status of an invention may be obtained from Patent Center. For more information about Patent Center, see https://www.uspto.gov/patents/apply/patent-center. Should you have questions on access to Patent Center, contact the Patent Electronic Business Center (PEBC) at 866-217-9197 (toll-free) or ebc@uspto.gov.
/DOUGLAS M WILLIS/
Primary Examiner, Art Unit 1624
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