Prosecution Insights
Last updated: September 17, 2026
Application No. 18/725,000

RECOMBINANT AAV FOR THE GENE THERAPY OF FABRY DISEASE

Non-Final OA §112
Filed
Jun 27, 2024
Priority
Dec 31, 2021 — CN PCT/CN2021/143573 +1 more
Examiner
ABEYRATNE-PERERA, HASHANTHI KOMITIGE
Art Unit
Tech Center
Assignee
Skyline Therapeutics Limited
OA Round
1 (Non-Final)
0%
Grant Probability
At Risk
1-2
OA Rounds
10m
Est. Remaining
0%
With Interview

Examiner Intelligence

Grants only 0% of cases
0%
Career Allowance Rate
0 granted / 1 resolved
-60.0% vs TC avg
Minimal +0% lift
Without
With
+0.0%
Interview Lift
resolved cases with interview
Typical timeline
3y 0m
Avg Prosecution
24 currently pending
Career history
16
Total Applications
across all art units

Statute-Specific Performance

§101
5.3%
-34.7% vs TC avg
§103
43.9%
+3.9% vs TC avg
§102
19.3%
-20.7% vs TC avg
§112
29.8%
-10.2% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1 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 . Claim status Claims 1-12 are pending. Claims 1-12 are under examination. Claim Objections Claims 11 and 12 are objected to under 37 CFR 1.75 as being a substantial duplicate of claim 10. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Claim 11 and 12 are substantial duplicates of claim 10, because they do not further limit claim 10 structurally or functionally. 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. Claim 12 recites ‘ wherein the disease is Fabry disease’. However, claim 10, on which the claim 12 dependent on, does not recite a disease. Therefore, the claim is indefinite for failing to distinctly claim the subject matter. Claim Rejections - 35 USC § 112 (b) 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 11 and 12 are 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. Claims 11 and 12 do not further limit the structure of the pharmaceutical composition comprising the rAAV recited on claim 10. The intended use of the rAAV to treat a disease associated with the deficiency of alpha galactosidase A (recited in claim 11) and the disease being Fabry disease (in claim12) are intended uses of the claimed rAAV molecule, and do not carry patentable weight. 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. Claims 1-10 are allowed Conclusion Claims 1-10 are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to HASHANTHI ABEYRATNE-PERERA whose telephone number is (571)272-6562. The examiner can normally be reached Monday-Friday 7:30 am- 5:00pm. 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, Peter Paras can be reached at 571-272-4517. 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. /HASHANTHI KOMITIGE ABEYRATNE-PERERA/ Examiner, Art Unit 1632 /MARCIA S NOBLE/ Primary Examiner, Art Unit 1632
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Prosecution Timeline

Jun 27, 2024
Application Filed
Aug 03, 2026
Examiner Interview (Telephonic)
Sep 09, 2026
Non-Final Rejection mailed — §112 (current)

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Prosecution Projections

1-2
Expected OA Rounds
0%
Grant Probability
0%
With Interview (+0.0%)
3y 0m (~10m remaining)
Median Time to Grant
Low
PTA Risk
Based on 1 resolved cases by this examiner. Grant probability derived from career allowance rate.

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