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/Restrictions and Status of the Claims
Applicant’s election of Group I comprising claims 1-20 and 28-30, as well as ‘Compound 19’ as the single specific compound in the response filed on December 22nd 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 1-30 are pending. Claims 21-27 are withdrawn from further consideration as being directed towards a nonelected invention. Claims 2-4, 7-10, and 13-18 are withdrawn from further consideration as being directed towards nonelected species until a generic claim has been found allowable. Claims 1, 5, 6, 11, 12, 19, 20, and 28-30 are examined on their merits.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 120 is acknowledged. Applicant has complied with all conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 based on the date of the provisional application 63/377,479 filed on September 28th 2022.
Information Disclosure Statement
The Information Disclosure Statement filed on January 14th 2025 is in compliance with the provisions of 37 CFR 1.97 and has been considered in full. A signed copy of references cited from the IDS is included with this Office Action.
Claim Objections
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.
Claims 29-30 are objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim may not depend on another multiply dependent claim. See MPEP § 608.01(n). For the purpose of examination, claims 29-30 will be treated as if they depend only on claim 1.
Claim Rejections - 35 USC § 101
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.
Claim 30 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more. The claim recites the inhibition of E3 ligase in cells with the compound of claim 1. This judicial exception is not integrated into a practical application because only the contact of the cells with the compound (i.e. a natural phenomenon) and the results of the contact (the inhibition of E3 ligase) is recited. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the method does not recite a patient population or an administration step but merely the contact of cells with the compound and results of said contact.
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, 5, 6, 11, 12, and 28-29 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rahm (Rahm et al., Journal of Medicinal Chemistry 2018 61 (6), 2533-2551).
Claim 1 is directed towards a compound of Formula (1):
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149
191
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Claims 5, 6, 11, and 12 further limit said structure to
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231
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Rahm teaches the compound,
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500
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(Rahm, pg. 2538, Table 3, Compound 18),
which is anticipatory of claims 1, 5, 6, 11, and 12.
Claim 28 is directed towards a composition comprising the compound of claim 1 and an additional component selected from “pharmaceutically acceptable carriers, vehicles, and excipients.” Rahm teaches the compound administered to a K562 (chronic myeloid leukemia) cell line in a solution of 1% DMSO (which includes the pharmaceutically acceptable ‘water’) (Rahm, pg. 2542), and Rahm therefore anticipates claim 28.
Claim 29 is directed towards a method of treating cancer via administration of the compound of claim 1. Rahm teaches administration of the compound to a K562 (chronic myeloid leukemia) cell line (Rahm, pg. 2542), anticipating claim 29.
Allowable Subject Matter
Claims 19-20 are free of the prior art.
Applicant has developed compounds of general Formula (I),
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149
191
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.
These compounds act as inhibitors of E3 ligase and are therefore useful in the treatment of various cancers. While compounds are found in the art that are anticipatory of applicant’s generic structure (see the above 102 rejections of claims 1, 5, 6, 11, 12, and 28-29, applicant’s particular chemical structures as described in claims 19-20 are free of the art and would not be predictable from the art.
Claims 19-20 are 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
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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