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 .
DETAILED ACTION
Election of Species and Status of the Claims
Applicant’s election without traverse of the compound,
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encompassing claims 1, 2, 5, 6, 8, 18, 33, 35, 36, 39, and 40 in the reply filed on June 3rd 2025 is acknowledged.
Applicant’s elected species is not found in the art. As recognized by MEPEP § 803.02(III)(C)(2):
If the elected species or group of patentably indistinct species is not anticipated by or obvious over the prior art, the examiner should extend the search and examination to a non-elected species or group of species that falls within the scope of a proper Markush grouping that includes the elected species. The search and examination should be continued until either (1) prior art is found that anticipates or renders obvious a species that falls within the scope of a proper Markush grouping that includes the elected species, or (2) it is determined that no prior art rejection of any species that falls within the scope of a proper Markush grouping that includes the elected species can be made. The examiner need not extend the search beyond a proper Markush grouping. In other words, the examiner need not extend the search to any additional species that do not share a single structural similarity and a common use with the elected species (i.e., do not belong to the same recognized physical or chemical class or to the same art- recognized class and/or do not have a common use and/or do not share a substantial structural feature of a chemical compound and a use that flows from the substantial structural feature). The examiner should continue examination of the Markush claim to determine whether it meets all other requirements of patentability (e.g., 35 U.S.C. 101 and 112, nonstatutory double patenting, and proper Markush grouping).
Claims 1, 2, 5, 6, 8, 9, 12, 15, 18-21, 24, 27, 31, 33, and 35-40 are pending. Claims 9, 12, 15, 19-21, 24, 27, 31, 37, and 38 have been withdrawn from further consideration as being directed towards nonelected species. Claims 1, 2, 5, 6, 8, 18, 33, 35, 36, 39, and 40 are examined on their merits.
35 U.S.C. § 102(a)(1) Rejections Overcome by Argument
Applicant’s arguments in the response filed on November 17th 2025 are acknowledged. Applicant argues that Wang’s compound TW-53 does not meet the limitations of claim 1 due to the proviso at the end of the claim. Applicant’s arguments are found persuasive, and the 102 rejections of the claims over Wang are thereby withdrawn.
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.
Claims 1, 2, 6, 8, 18, 33, 39, and 40 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zikan (CS242022B1 published on April 17th 1986; Google Patents Translation Attached).
The claims are directed towards compounds of the genus,
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Zikan teaches the compound,
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(Zikan, pg. 3; see Zikan, Translation, claim 1).
This compound is equivalent to the compound of claim 1 wherein Z is CH2, Z is ortho, m is 1, R1 is chlorine, n is 0, p is 1, R3 is NO2, and R4 is H.
The compound is therefore anticipatory of claims 1, 2, 6, 8, 18, and 33.
Claim 39 is directed towards a pharmaceutical composition comprising the compound of claim 1. Zikan teaches the treatment of Hymenolepis nana (tapeworm) infection via administration of the compound (Zikan, translation, pg. 1). As the compound is necessarily administered in the form of a pharmaceutical composition, Zikan anticipates claim 39.
Claim 40 is directed towards a method for treating a hormone-mediated disease via administration of a compound according to claim 1. Zikan teaches the treatment of Hymenolepis nana (tapeworm) infection via administration of the compound, and demonstrates this activity with a mouse model wherein the mouse is infected with tapeworm eggs (Zikan, translation, pg. 1). As this tapeworm infection involves the growth and development of the tapeworm, it is thereby “hormone-mediated” and Zikan anticipates claim 40.
Claims 1, 2, 5, 6, 8, 18, 33, 35, 36, 39, and 40 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ng (Ng et al., Bioorganic & Medicinal Chemistry Letters, Volume 29, Issue 16, 2019, Pages 2307-2315).
Ng teaches the compound,
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(Ng, pg. 2309, Compound 20),
which is equivalent to applicant’s compound genus wherein Z is CH2, Z is para, m is 0, n is 0, p is 1, R3 is CN, and R4 is H. Ng thereby anticipates claims 1, 2, 5, 6, 8, 18, 33, and 36.
Ng teaches the compound for the treatment of acute myeloid leukemia (Ng, pg. 2309). As the compound would necessarily be administered in a pharmaceutical composition, Ng anticipates claim 39.
Ng teaches the compound for the treatment of acute myeloid leukemia (Ng, pg. 2309). As hormone receptors are known to affect the growth of myeloid leukemia1, it is thereby ‘hormone-mediated,’ and Ng anticipates claim 40.
Allowable Subject Matter
Claim 35 is free of the art.
Applicant has developed compounds of the genus,
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These compounds act as inhibitors of androgen receptors and are useful in the treatment of hormone-mediated diseases.
Similar compounds have been developed in the art for the treatment of diseases such as prostate cancer. See Wang (U.S. Patent No. 8,557,812 issued on October 15th 2013), who teaches compounds, including:
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(Wang, col. 109-110, TW-82).
Applicant’s particular compounds, as recited in claim 35, are not found in the art and would not be predictable to one of ordinary skill in the art.
Claim 35 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Claims 1, 2, 5, 6, 8, 18, 33, 36, 39, and 40 are rejected.
Claim 35 is objected to.
THIS ACTION IS MADE FINAL. 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 Anthony Seitz whose telephone number is (703)756-4657. The examiner can normally be reached 7:30 AM ET - 5:00 PM ET M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey 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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/A.J.S./Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
1 For evidentiary support, see Minden (Minden et al., Estrogen Receptor Beta Is a Novel Target in Acute Myeloid Leukemia, Blood, Volume 126, Issue 23, 2015, Page 1395)