Prosecution Insights
Last updated: August 06, 2026
Application No. 18/920,313

FOUR-AXIS ASYMMETRIC ORTHOKERATOLOGY LENS AND MANUFACTURING METHOD

Non-Final OA §102§112
Filed
Oct 18, 2024
Priority
Feb 29, 2024 — CN 202410228718.X +1 more
Examiner
LEI, JIE
Art Unit
Tech Center
Assignee
Shanghai Fulo Medical Instrument Co. Ltd.
OA Round
1 (Non-Final)
73%
Grant Probability
Favorable
1-2
OA Rounds
1y 0m
Est. Remaining
90%
With Interview

Examiner Intelligence

Grants 73% — above average
73%
Career Allowance Rate
668 granted / 916 resolved
+12.9% vs TC avg
Strong +17% interview lift
Without
With
+16.7%
Interview Lift
resolved cases with interview
Typical timeline
2y 9m
Avg Prosecution
45 currently pending
Career history
950
Total Applications
across all art units

Statute-Specific Performance

§101
0.7%
-39.3% vs TC avg
§103
45.6%
+5.6% vs TC avg
§102
26.6%
-13.4% vs TC avg
§112
22.9%
-17.1% vs TC avg
Black line = Tech Center average estimate • Based on career data from 916 resolved cases

Office Action

§102 §112
DETAILED ACTION The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . Notice of Pre-AIA or AIA Status 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 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. Priority Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file. Information Disclosure Statement The information disclosure statements (IDS) submitted on 10/18/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner. 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 1-10 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 pre-AIA the applicant regards as the invention. Regarding claim 1, cited term of “…and a horizontal surface of an apex of an inner surface of the four-axis asymmetric orthokeratology lens” (line 8-9) is vague and renders the claims indefinite. As the four-axis asymmetric orthokeratology lens has a plurality of inner surfaces (see fig. 2 of instant application specification). It is not clear that the cited “an inner surface” refers to which one of the surfaces. Do applicants mean that “…and a horizontal surface of an apex of the inner surface (--inner surface of the adaptation curve zone (3)) of the four-axis asymmetric orthokeratology lens”? Further, cited term of “a curvature distribution of the secondary flat meridional line of the four-axis asymmetric orthokeratology lens on the inner surface of the adaptation curve zone is consistent with a curvature distribution of an outer surface of a secondary flat meridional line of the cornea in the specific annular zone” (line 28-31) is vague and renders the claims indefinite. Since “the secondary flat meridional line of the four-axis asymmetric orthokeratology lens” has a specified geometrical configuration limitation (see claim line 13-15), it is unclear that how the secondary flat meridional line of the cornea fits the limitation. Claim cited term in line 36-39 has same unclear issue above. Claims 2-6 are rejected as containing the deficiencies of claim 1 through their dependency from claim 1. Regarding claim 7, cited term of “calculating a mean sagittal depth between an anterior surface of the cornea and a horizontal surf ace of an apex of the cornea” (line 20-22) is vague and renders the claims indefinite. It is unclear how to calculate a value of a mean sagittal depth. For independent claim 7, a method of calculating a mean sagittal depth should be specified, like that in claim 1, line 6-8. Claims 8-10 are rejected as containing the deficiencies of claim 7 through their dependency from claim 7. Therefore proper amendments are required in order to clarify the scopes of the claims and overcome the rejections. Allowable Subject Matter Claims 1 and 7 are rejected as having 112 issues, but would be allowable if the 112 rejections are overcome by proper amendments. The following is an examiner’s statement of reasons for allowance: The prior art taken singularly or in combination fails to anticipate or fairly suggest the limitations of the independent claims, in such a manner that a rejection under 35 U.S.C. 102 or 103 would be proper. In regard to independent claims 1 and 7, the closest prior art are US 20220082862 of Wu et al and US 20050105046 of Tung. Regarding Claims 1 and 7, Wu teaches a four-axis asymmetric orthokeratology lens (abstract; fig. 1), comprising: a base curve zone (1), and a reverse curve zone (2), an adaptation curve zone (3), and a peripheral curve zone (4) that are successively formed outward from a periphery of the base curve zone (1) (fig. 1, 11-14), wherein a plurality of meridional lines are defined on the four-axis asymmetric orthokeratology lens (fig. 1, meridional lines in zone 13); a center of a circle of the base curve zone (1) is configured to correspond to a center of a cornea (fig. 3, B), a curvature distribution of the four-axis asymmetric orthokeratology lens on the inner surface of the adaptation curve zone is consistent with a curvature distribution of an outer surface of the cornea in the specific annular zone (fig, 3, B, C). Tung teaches a four-axis asymmetric orthokeratology lens (abstract; figs. 1-6), comprising: a base curve zone (1), and a reverse curve zone (2), an adaptation curve zone (3), and a peripheral curve zone (4) that are successively formed outward from a periphery of the base curve zone (1) (fig. 4, 21, 21a, 26, 28), wherein a center of a circle of the base curve zone (1) is configured to correspond to a center of a cornea (¶[0028]- ¶[0030]), a curvature distribution of the four-axis asymmetric orthokeratology lens on the inner surface of the adaptation curve zone is consistent with a curvature distribution of the cornea in the specific annular zone (¶[0049]), and adjacent sector ring zones are gradually transited (fig. 2). But none of them teaches that wherein the adaptation curve zone (3) is divided into four sector ring zones by the flattest meridional line (6), the secondary flat meridional line (8), the steepest meridional line (7), and the secondary steep meridional line (9); and wherein curvature distributions of the flattest meridional line, the secondary flat meridional line, the steepest meridional line and the secondary steep meridional line of the four-axis asymmetric orthokeratology lens on the inner surface of the adaptation curve zone are consistent with curvature distributions of the flattest meridional line, the secondary flat meridional line, the steepest meridional line and the secondary steep meridional line of the cornea in the specific annular zone. Examiner’s Note Regarding the references, the Examiner cites particular figures, paragraphs, columns and line numbers in the reference(s), as applied to the claims above. Although the particular citations are representative teachings and are applied to specific limitations within the claims, other passages, internally cited references, and figures may also apply. In preparing a response, it is respectfully requested that the Applicant fully consider the references, in their entirety, as potentially disclosing or teaching all or part of the claimed invention, as well as fully consider the context of the passage as taught by the reference(s) or as disclosed by the Examiner. Conclusion Any inquiry concerning this communication or earlier communication from the examiner should be directed to Jie Lei whose telephone number is (571) 272 7231. The examiner can normally be reached on Mon.-Thurs. 8:00 am to 5:30 pm. If attempts to reach the examiner by the telephone are unsuccessful, the examiner's supervisor, Stephone Allen can be reached on (571) 272 2434.The Fax number for the organization where this application is assigned is (571) 273 8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published application may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Services Representative or access to the automated information system, call 800-786-9199(In USA or Canada) or 571-272-1000. /JIE LEI/Primary Examiner, Art Unit 2872
Read full office action

Prosecution Timeline

Oct 18, 2024
Application Filed
Jul 31, 2026
Non-Final Rejection mailed — §102, §112 (current)

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

1-2
Expected OA Rounds
73%
Grant Probability
90%
With Interview (+16.7%)
2y 9m (~1y 0m remaining)
Median Time to Grant
Low
PTA Risk
Based on 916 resolved cases by this examiner. Grant probability derived from career allowance rate.

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