Prosecution Insights
Last updated: July 17, 2026
Application No. 18/539,471

PCSK9 INHIBITORS AND METHODS OF USE THEREOF

Non-Final OA §112
Filed
Dec 14, 2023
Priority
Dec 16, 2022 — provisional 63/387,731 +1 more
Examiner
HEASLEY, MEGHAN CHRISTINE
Art Unit
1626
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Astrazeneca AB
OA Round
1 (Non-Final)
77%
Grant Probability
Favorable
1-2
OA Rounds
5m
Est. Remaining
99%
With Interview

Examiner Intelligence

Grants 77% — above average
77%
Career Allowance Rate
96 granted / 124 resolved
+17.4% vs TC avg
Strong +32% interview lift
Without
With
+32.2%
Interview Lift
resolved cases with interview
Typical timeline
3y 1m
Avg Prosecution
61 currently pending
Career history
162
Total Applications
across all art units

Statute-Specific Performance

§101
1.4%
-38.6% vs TC avg
§103
47.0%
+7.0% vs TC avg
§102
21.0%
-19.0% vs TC avg
§112
12.2%
-27.8% vs TC avg
Black line = Tech Center average estimate • Based on career data from 124 resolved cases

Office Action

§112
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 1-20, 22, and 25-28 are pending. Claims 13-14 and 25-28 are withdrawn. Claims 2 and 19 are rejected. Claims 1, 3-12, 15-18, 20, and 22 are objected to. Information Disclosure Statement The Information Disclosure Statements (IDS’s) submitted on 2/26/2024 (two) and 2/20/2026 were considered by the Examiner. Election/Restrictions Applicant’s election without traverse of Group I and the species Example 21, shown here: PNG media_image1.png 185 385 media_image1.png Greyscale , in the reply filed on 5/4/2026 is acknowledged. Claims 1-12, 15-20 and 22 embrace Applicant’s elected species and are therefore under examination. Applicant’s elected species is free of the prior art. Additional items were discovered below incidental to the search of the elected species (objections and 112 rejections) and are presented here in the interest of compact prosecution. Claims 13-14 and 25-28 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claim Objections Claim 1 is objected to because of the following informalities: P. 3: third from last line, Examiner recommends placing a “:” after “(B-1) or (B-2)”; P. 3, B(i) structure on second to last line has formatting errors and should be replaced with a structure showing proper connectivity; P. 4: line 7, Examiner recommends changing the indentation of “wherein C is selected…..” to further to the left; P. 4: third from last line: Examiner recommends changing the indentation of “(ii) one or more groups selected from…” further to the left. Claim 7 is objected to because of the following informalities: P. 10, line 2, Examiner recommends deleting the word “compounds”; Multiple formulas of claim 7 have formatting errors which should be fixed. Claim 10 is objected to because of the following informalities: The formatting on the structure of “(C-1)” has an error and should be fixed (p. 13); On p. 13, letter “(iv)”, Examiner recommends replacing the “P” of “piperazinyl” to a lower case “p”. Claim 15 is objected to because of the following informalities: Claim 15 does not end with a period. Claim 16 is objected to because of the following informalities: There is a formatting error on the structure of “(C-2)”. Claim 18 is objected to because of the following informalities: There are multiple formatting errors of various structures; Claim does not end in a period. Claim 19 is objected to because of the following informalities: P. 23, Line 1 should have a space between “1” and “or”; P. 26, last line, delete the “or”. Claim 20 is objected to because of the following informalities: P. 28, line 1, add the following: “selected from the group consisting of:”. Appropriate correction is required. Claims 2-6, 8-9, 11-12, 17, and 22 are additionally objected to for ultimately depending from claim 1 and not remedying the deficiencies. 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. Claims 2 and 19 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. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 2 recites the broad recitation “A1-A3”: PNG media_image2.png 484 355 media_image2.png Greyscale , and the claim also recites “A4-A14”, examples shown here: PNG media_image3.png 201 645 media_image3.png Greyscale , which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). For example, in the present instance, claim 19 recites the broad recitation “IA”: PNG media_image4.png 194 455 media_image4.png Greyscale , and the claim also recites “I-A1”, shown here: PNG media_image5.png 189 402 media_image5.png Greyscale , which is the narrower statement of the range/limitation. There are multiple other broad to narrow examples in claim 19, including for example, (I-B) and (I-B1). The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. 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 19 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. Claim 19 depends from claim 1 and in the last two lines on p. 28 recites variables not defined in neither claims 1 nor 19. 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. Closest Prior Art The closest prior art is WO2020150474 (disclosed on 2/26/2024 IDS). WO2020150474 discloses the following compound on p. 70: PNG media_image6.png 78 180 media_image6.png Greyscale , which is an intermediate in the following reaction scheme: PNG media_image7.png 213 584 media_image7.png Greyscale . The intermediate shown supra differs from a compound from the instant claims because RA1 = halo (Br) and RB2 = CH3. On p. 4 of the instant claims (line 6), there is a wherein clause that recites the following: “wherein when RA1 is H or halo, RB2 is C1-2 alkyl-OH or CH2C(=O)NHMe”, which is different from the prior art compound shown supra. Therefore, the prior art does not anticipate, nor render obvious, the instant claims. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEGHAN C HEASLEY whose telephone number is (571)270-0785. The examiner can normally be reached Monday - Friday 8:30-4:30 PM. 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, Amy Clark can be reached at 571-272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /MEGHAN C HEASLEY/Examiner, Art Unit 1626
Read full office action

Prosecution Timeline

Dec 14, 2023
Application Filed
Jun 03, 2026
Non-Final Rejection mailed — §112 (current)

Precedent Cases

Applications granted by this same examiner with similar technology

Patent 12678428
A SYNERGISTIC COMPOSITION FOR INHIBITING VASCULAR CALCIFICATION
2y 7m to grant Granted Jul 14, 2026
Patent 12655145
P2X3 MODULATORS
3y 10m to grant Granted Jun 16, 2026
Patent 12655127
FUSED RING COMPOUND AS WEE-1 INHIBITOR
2y 10m to grant Granted Jun 16, 2026
Patent 12637432
INHIBITORS OF ACK1/TNK2 TYROSINE KINASE
3y 3m to grant Granted May 26, 2026
Patent 12630564
INTERNAL CYCLIC SULPHIAMIDINE AMIDE-ARYL AMIDE COMPOUND AND USE THEREOF FOR TREATING HEPATITIS B
3y 10m to grant Granted May 19, 2026
Study what changed to get past this examiner. Based on 5 most recent grants.

Strategy Recommendation AI-generated — please review before filing

Get a prosecution strategy drawn from examiner precedents, rejection analysis, and claim mapping.
Typically takes 5-10 seconds — AI-generated, attorney review required before filing

Prosecution Projections

1-2
Expected OA Rounds
77%
Grant Probability
99%
With Interview (+32.2%)
3y 1m (~5m remaining)
Median Time to Grant
Low
PTA Risk
Based on 124 resolved cases by this examiner. Grant probability derived from career allowance rate.

Sign in with your work email

Enter your email to receive a magic link. No password needed.

Personal email addresses (Gmail, Yahoo, etc.) are not accepted.

Free tier: 3 strategy analyses per month