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 Claims
Claims 1-12 are pending in the instant application and subject to examination.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. PCT/CN2022/126611, filed on 10/21/2022.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 04/22/2024 and 05/19/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Rejections - 35 USC § 112(b)
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.
Claims 7, 9-10 and 12 are 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.
Claim 7 further limits claim 1, regarding a genus of compound that are PARP-1 degradation agents according to instant Formula (I), to wherein the compound of Formula (I), or the stereoisomer, deuterated compound, solvate, pharmaceutically acceptable salt or co-crystal thereof is selected from one of the structures in “Table A”. Claim 7 does not include any “Table A”, although the instant Specification does include a table titled as “Table A” (pages 25-30). Claim 7 is indefinite because the claim is not complete in itself, and does not include the identification of the compound(s) being claimed. Given that claim 7 is drawn to a compound or set of compounds, there is no apparent necessity in identifying the compounds by reference to table(s) of the instant disclosure, because the compounds can be readily represented by name or structure within the claim. Applicant is referred to MPEP § 2173.05(s), included below:
Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (citations omitted)
Claims 9-10 are indefinite because the category of invention being claimed is ambiguous. Claim 9 purports to limit the genus of PARP-1 degradation agents of claim 1 to “the use” of the PARP-1 degradation agent or the stereoisomer, deuterated compound, solvate, pharmaceutically acceptable salt or co-crystal thereof in the preparation of a drug for treating/preventing a PARP-1-mediated disease. Claim 10 further limits claim 9 to wherein the disease to be treated/prevented is selected from a Markush group of cancers. Thus, it is not clear whether claims 9-10 are drawn to a composition of matter, the manufacture of a medicament, or a method of treating/preventing disease(s).
The term “preferably”, which appears three times in claim 12, renders the claim indefinite because it is unclear whether the limitations following the term are part of the claimed invention. See MPEP 2173.05(d).
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.
Claims 9-10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claims are “use” claims and do not fall within at least one of the four categories of patent eligible subject matter because they do not recite any method, machine, manufacture, or composition of matter as the claimed invention, but rather are directed to the "use" of a PARP-1 degradation agent.
Claims Free of the Prior Art
Claims 1-6, 8 and 11 are allowed. The following is an examiner’s statement of reasons for allowance: Prior art does not teach or reasonably suggest, alone or in combination, a PARP-1 degradation agent represented by instant Formula (I) as claimed in claim 1, or stereoisomer, deuterated compound, solvate, pharmaceutically acceptable salt or co-crystal thereof. Prior art does not teach or reasonably suggest, alone or in combination, a pharmaceutical composition comprising a PARP-1 degradation agent represented by instant Formula (I) as claimed in claim 1, or stereoisomer, deuterated compound, solvate, pharmaceutically acceptable salt or co-crystal thereof, and a pharmaceutically acceptable carrier and/or excipient.
Closest Prior Art:
The closest prior art is found in Johannes (Johannes, J. W., et al.; Journal of Medicinal Chemistry, v64, pp14498-14512; 2021)1 and Gao (CN111606969A)2. Johannes teaches a study in the selective inhibition of the enzyme Poly-ADP-ribose-polymerase 1 (PARP-1) by means of the compound AZD53053, a compound that corresponds to the “PLM” moiety of the exemplary PARP-1 degradation agents, for example in instant Compound 14, shown below:
Instant Application
Johannes
PNG
media_image1.png
134
392
media_image1.png
Greyscale
Compound 1
PNG
media_image2.png
114
264
media_image2.png
Greyscale
AZD5305
Johannes does not teach or suggest the incorporation of the PARP-1 inhibitor AZD5305 as a moiety in a proteolysis targeting chimera (PROTAC) together with an E3-ligase targeting moiety and an effective linker. Cao discloses PARP-1 degradation agents and application thereof into anti-tumor treatment (Abstract, section “Technical Field”). Cao’s PARP-1 degradation agents comprise
a PARP-1 targeting moiety (Abstract and Summary of the Invention, statement 6 – see page 3) that is distinct from the PLM moiety of the instant application, as shown in the table below:
Instant Application
Cao
PNG
media_image1.png
134
392
media_image1.png
Greyscale
Compound 1
PNG
media_image3.png
200
400
media_image3.png
Greyscale
Cao’s PARP-1 degradation agents also employ a distinct E3-ligase targeting moiety and distinct linker type from those of the instant Formula (I). A person of ordinary skill in the art would not find motivation in either Johannes or Cao to make and use PARP-1 degradation agents that incorporate the AZD5305 moiety into PARP-1 degradation agents according to the instant Formula (I).
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to W. JUSTIN YOUNGBLOOD whose telephone number is (703)756-5979. The examiner can normally be reached on Monday-Thursday from 8am to 5pm. The examiner can also be reached on alternate Fridays.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey S. Lundgren, can be reached at telephone number (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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Examiner interviews are available via a variety of formats. See MPEP § 713.01. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) Form at https://www.uspto.gov/InterviewPractice.
/W.J.Y./Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
1 Cited in Applicant’s Information Disclosure Statement dated 04/22/2024.
2 Cited in Applicant’s Information Disclosure Statement dated 04/22/2024.
3 5-[4-[(7-ethyl-6-oxo-5H-1,5-naphthyridin-3-yl)methyl]piperazin-1-yl]-N-methyl-pyridine-2-carboxamide
4 N-(1'-(2-(2,6-dioxopiperidin-3-yl)-1,3-dioxoisoindolin-5-yl)-[1,4'-bipiperidin]-4-yl)-5-(4-((7-ethyl-6-oxo-5,6-dihydro-1,5-naphthyridin-3-yl)methyl)piperazin-1-yl)picolinamide
