Office Action Predictor
Application No. 18/016,886

PREVENTION AND/OR TREATMENT OF EYE DISEASE BY COLLAGEN FIBER CROSSLINKING

Non-Final OA §101§102§112
Filed
Jan 19, 2023
Examiner
PRICE, NATHAN R
Art Unit
3783
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Fibertech Co., LTD.
OA Round
1 (Non-Final)
52%
Grant Probability
Moderate
1-2
OA Rounds
4y 4m
To Grant
91%
With Interview

Examiner Intelligence

52%
Career Allow Rate
261 granted / 498 resolved
Without
With
+38.4%
Interview Lift
avg trend
4y 4m
Avg Prosecution
50 pending
548
Total Applications
career history

Statute-Specific Performance

§101
1.2%
-38.8% vs TC avg
§103
39.5%
-0.5% vs TC avg
§102
31.4%
-8.6% vs TC avg
§112
20.3%
-19.7% vs TC avg
Black line = Tech Center average estimate • Based on career data

Office Action

§101 §102 §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. Response to Amendment This office action is responsive to the preliminary amendment filed on 1/19/23. As directed by the amendment: 3-13 and 15-20 have been amended, no claims have been cancelled, and no new claims have been added. Thus, claims 1-25 are presently pending in this application. Drawings The subject matter of this application admits of illustration by a drawing to facilitate understanding of the invention. Applicant is required to furnish a drawing under 37 CFR 1.81(c). No new matter may be introduced in the required drawing. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(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. Claim s 14, 18, 22 , and 24 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because claims 14 and 18 are directed to products, but also positively recite method steps (see further discussion under 112(b) below) and claims 22 and 24 attempt to claim a process or use (use of a photoexcitable compound) without setting forth any steps involved in the process (s ee MPEP 2173.05(q) ; s ee further discussion under 112(b) below ). 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 appl icant regards as his invention. Claims 1- 25 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. Regarding claim 1, the limitations “the sclera”, “the equatorial region”, “the eye”, and “the posterior pole” lack antecedent basis. Regarding claim 2, the limitations “the subconjunctiva” and “the capsule of Tenon” lack antecedent basis. Regarding claim 21, the limitations “the subconjunctiva”, “the capsule of Tenon”, “the eye”, and “the sclera” lack antecedent basis. Regarding claim 22, the limitations the subconjunctiva”, “the capsule of Tenon”, “the eye”, “the sclera”, “the equatorial region”, and “the posterior pole” lack antecedent basis. Regarding claim 23, the limitation “the sclera” lacks antecedent basis. Regarding claim 24, the limitations “the manufacture”, “the sclera”, “the equatorial region”, “the eye”, and “the posterior pole” lack antecedent basis. Regarding claim 25, the limitations “the sclera”, “the equatorial region”, “the eye”, and “the posterior pole” lack antecedent basis. Claims 14 and 18 are initially directed to a product (“kit”), but appear to positively recite a method step. For the purposes of examination, the claim s will be interpreted as if the probe of the kit is “configured to be used ” as claimed. Claims 22 and 24 appear to recite a process or use (use of a photoexcitable compound) without setting forth any steps involved in the process. Claim 24 simply recites use of a photoexcitable compound without reciting anything resembling a step. Claim 22 recites limitations that, as worded, cannot clearly be interpreted as method steps. Remaining claims are rejected due to dependency on claims rejected above. Claim Rejections - 35 USC § 102 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. Claim(s) 1- 25 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Iseli et al. (US 20170087017) . Regarding claims 1- 12 and 25 , Iseli et al. teaches a photosensitizer compound (concentration/mixture of riboflavin ; par. 0353, 0361) comprising a photoexcitable compound ( riboflavin 0.5%; par. 0353, 0361). This disclosed compound anticipates the limitations regarding the compound from claims 1, 9, 10, and 25, and is fully capable of being utilized according to the variously recited functions and intended procedures of claims 1-12 and 25 ; therefore, disclosure of this compound alone anticipates all of claims 1-12 and 25 . Regardless, in addition to the clear anticipation of these claims provided by the disclosure of the composition as set forth above, a further analysis of the individual claim limitations relative to the disclosure of Iseli et al. will follow below. Further r egarding claims 1-12 and 25 , Iseli et al. further discloses [claim s 1 and 25 ] a photosensitizer composition (concentration/mixture of riboflavin; par. 0353, 0361) for use in prevention/treatment of myopia (par. 0350) , comprising a photoexcitable compound (riboflavin; par. 0353, 0361), wherein the prevention and/or treatment compr ises crosslinking treatment in the sclera of the equatorial region/posterior pole of the eye (par. 0311- 0315); [claim 2] administering the composition to the subconjuctiva /capsule of Tenon of the eye (par. 0345); [claim s 3 -5 ] the crosslinking treatment comprises emitting toward the sclera light comprising light having a wavelength absorbed by the compound of 300-550 nm and illuminance of 1 to 30 mW /cm 2 (par. 0349); [claim 6] applying light to the sclera for 1 to 10 minutes (par. 0355); [claim 7] emitting light in the presence of atmosphere (atmosphere will inherently be “present” at least somewhere in the vicinity of the procedure); [claim 8] for use as an injection (solution of par. 0353 is fully capable of being injected); [claim 9] the photoexcitable compound is comprised in a concentration ranging from 0.001 to 1%(w/v) (par. 0353); [claim 10] the photoexcitable compound is riboflavin (par. 0353, 0361); [claim 11] the myopia is pathological myopia (par. 0288, 0350); [claim 12] the myopia is associated with posterior staphyloma (treats pathological myopia and is thus fully capable of treating myopia associated with its developmental factors, such as posterior staphyloma). Regarding claims 13-20, Iseli et al. discloses [claims 13, 16, and 17] a kit comprising the photosensitizer composition of claim 1 (see above) and a probe 10 (fig. 3A-F ) for emitting light (par. 0326) comprising light having a wavelength absorbed by the photoexcitable compound comprises in the photosensitizer composition (par. 0349 ), the wavelength ranging from 300-550 nm and illuminance ranging from 1 to 30 mW /cm 2 (par. 0349); [claim 14 , as best understood ] the probe is used to be arranged along the sclera at the equatorial region of the eye/posterior pole of the eye (structure of fig. 3A-F is fully capable of such placement; additionally, see par. 0315, 0345 , and fig. 3A ); [ claim 15 ] the probe comprises an emission surface 35 for emitting light (par. 0326), to which a member comprising at least one pore is attached (portion of 10 comprising pore 27/28); [claim 18 , as best understood ] the probe is used to emit the light for 1 to 10 minutes ( structure of fig. 3A-F is fully capable of being used according to this time frame; additionally, see par. 0355 ); [claim 19] the composition is enclosed in a unit-dose container (the composition will inherently be contained prior to use, and will require at least one unit-dose of containment to meet the requirement for dosed release as described in par. 0320); and [claim 20] a light source device connectable to the probe (par. 0342). Regarding claim 21, Iseli et al. discloses a method for preventing and/or treating myopia (par. 0311-0315, 0350), comprising: administering a photosensitizer composition (concentration/mixture of riboflavin; par. 0353, 0361) comprising a photoexcitable compound (riboflavin 0.5%; par. 0353, 0361) to the subconjuntiva or the capsule of Tenon of the eye ( par. 0345 ) , and emitting toward the sclera light comprising light having a wavelength absorbed by the photoexcitable compound (par. 0349), thereby resulting in crosslinking of a collagen fiber contained in the sclera (par. 0311-0315). Regarding claim 22, as best understood, Iseli et al. discloses a method for crosslinking collagen fiber (par. 0311-0315) , wherein a photosensitizer composition (concentration/mixture of riboflavin; par. 0353, 0361) comprising a photoexcitable compound (riboflavin 0.5%; par. 0353, 0361) administered to the subconjunctiva or the capsule of Tenon of the eye (par. 0345) is involved in crosslinking of a collagen fiber in the sclera of the equatorial region or the posterior pole of the eye (par. 0311-0315) under irradiation of light comprising light having a wavelength absorbed by the photoexcitable compound (par. 0349). Regarding claim 23, Iseli et al. discloses a method for emitting light (par. 0311-0315, 0349) , comprising emitting toward the sclera light comprising light having a wavelength ranging from 300 to 550 nm (par. 0349) with an illuminance ranging from 1 to 30 mW /cm 2 (par. 0349) for 1 to 10 minutes (par. 0355). Regarding claim 24, as best understood, Iseli et al. discloses use of a photoexcitable compound ( riboflavin, par. 0353, 0361) in the manufacture of a photosensitizer composition (concentration/mixture of riboflavin; par. 0353, 0361; the existence of the composition as claimed is inherently the result of its manufacture) for use in prevention and/or treatment of myopia (par. 0311-0315, 0350), wherein the prevention and/or treatment comprises crosslinking treatment of the sclera at the equatorial region of the eye/posterior region of the eye (par. 0311-0315). Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT NATHAN R PRICE whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)270-5421 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Mon-Fri 8:00am-4:00pm Eastern time . 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, FILLIN "SPE Name?" \* MERGEFORMAT Michael Tsai can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT 571-270-5246 . 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. /NATHAN R PRICE/ Primary Examiner, Art Unit 3783
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Prosecution Timeline

Jan 19, 2023
Application Filed
Sep 03, 2025
Non-Final Rejection — §101, §102, §112
Apr 03, 2026
Response after Non-Final Action

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Prosecution Projections

1-2
Expected OA Rounds
52%
Grant Probability
91%
With Interview (+38.4%)
4y 4m
Median Time to Grant
Low
PTA Risk
Based on 498 resolved cases by this examiner