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 .
Applicant's submission filed on 7/20/2026 has been entered.
Status of Prior Rejections/Response to Arguments
RE: Rejection of claims 1-8 under 35 USC 112(b):
The amendments to claim 1 is effective to overcome the prior rejection. The new matter has been removed. The rejection is withdrawn.
RE: Rejection of claims 1-8 and 33 under 35 USC 112(b):
Cancellation of claims 2, 5 and 33 render the rejections thereof moot.
The amendments to the remaining claims are effective overcome the previous rejections. The previous rejections are withdrawn.
RE: Rejection of claim 33 under 35 USC 112(d):
Cancellation of claim 33 renders the rejection thereof moot.
RE: Rejection of claims 1-8, 32 and 33 under 35 USC 103 over Wongs, Prokera Technical Guide, and Mcgaughy et al:
Applicants have traversed the rejection of record on the grounds that the claims, as currently amended, require, inter alia:
capturing microscopic or photographic documentation of the ocular surface and confirming, from [that documentation] that the dehydrated amniotic membrane remains centered over the cornea…
after the therapeutic treatment period, conducting a corneal assessment to evaluate healing… then only after the corneal assessment indicates the ocular surface is ready for biometric measurements,
removing the contact lens…and then
performing biometric measurements.
Applicants specifically point out that Wongs et al was only asserted to perform biometric measurements after removal of the amniotic membrane. Thus Wongs et al does not disclose the currently claimed sequence of steps. Applicants assert the additional references do not cure the deficiency.
In response, the amendments are effective to overcome the rejection previously of record. The previous rejection is withdrawn. A new ground of rejection is set forth below.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required:
The specification fails to recite “wherein the therapeutic treatment period includes a period of at least one week” as recited in claim 8. Claim 8 is part of the original disclosure, so there is support for the limitation, but the specification should be amended to recite the therapeutic treatment period duration.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 3, 4, 6, 8 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Yeu et al (Clinical ophthalmology, 2022), evidenced by Prokera® Technical Guide (2014), and in view of Mcgaughy et al (Ophthalmic Pearls, 2015) and Hopkinson (WO 24/189380).
Yeu et al report that overlooked epithelial basement membrane dystrophy (EBMD) may lead to improper intraocular lens (IOL) calculations for use in cataracts surgery and post-operative corneal healing problems (See Yeu et al, Pg 785, Introduction). Thus, Yeu et al treat the EBMD in order to optimize the ocular surface prior to surgery in order to stabilize IOL calculations and reduce postoperative refractive surprises (See Yeu et al, abstract: Conclusion).
The treatment group method of Yeu et al is comparable to the instant claims as follows:
Regarding claims 1, 8 and 32: The method of Yeu et al is preparing patients for cataract surgery by improving corneal health prior to surgery.
Yeu et al select patients. Inclusion criteria included, inter alia, ‘intending to undergo cataract surgery’ (See Yeu et al, Pg 786, Methods). Thus Yeu et al identified a patient in need of cataract surgery/scheduled for cataract surgery.
Another inclusion criteria was ‘had significant EBMD’. (See id). Thus Yeu et al also diagnosed EBMD (an ocular surface condition/corneal surface irregularity) in the eye of a patient, and determined that the EBMD (ocular surface condition) required therapeutic treatment before biometric measurements.
After meeting criteria, patients underwent baseline biometric measurements (slit lamp examination/photography without and with Fluorescein staining, corneal topography, and IOL calculations) (See id).
Yeu et al perform corneal debridement, and then place Prokera® Slim cryopreserved amniotic membrane (CAM) on the ocular surface (See Yeu et al, Pg 787, Methods). The placement of the CAM is comparable to the steps related to placing the sterile and dehydrated amniotic membrane directly onto the ocular surface.
Yeu et al examine the patients daily for the first postoperative week. Examine included slit lamp photography with fluorescein staining to evaluate closure of the epithelial defect while the self-retaining CAM was in place (See id). The one week period reads on a therapeutic treatment period of at least one week. At least the exam on the final day reads on after the therapeutic treatment period, conducting a corneal assessment to evaluate healing and ocular surface improvement.
Yeu et al state ‘after complete epithelialization, the self-retaining CAM was removed’ (See id). This reads on determine, based on the corneal assessment, that the ocular surface is ready for biometric measurements/verifying an improvement in corneal health and removing the contact lens after verifying the improvement in the ocular surface/corneal health.
A therapeutic bandage contact lens (BCL) as placed for one week to mechanically protect the new healed surface, then at one month corneal topography and IOL calculations were repeated. The corneal topography and IOL calculations were repeated again two weeks later (See Yeu et al, paragraph spanning Pg 787-788). The corneal topography and IOL calculations read on after removing the contact lens, performing biometric measurements on the eye.
Yeu et al report evaluating refraction and ocular surface stability after cataract surgery (See Yeu et al, Pg 788, Methods), which means that an IOL was selected and cataract surgery was performed.
Yeu et al differ from claims 1, 8 and 33 in that they use a Prokera® Slim CAM, not a sterile and dehydrated amniotic membrane in combination with a contact lens, and they do not ensure proper placement of the amniotic membrane on the eye by capturing microscopic or photographic documentation.
However, two main types of amniotic membrane products were known for in-office use: cryopreserved AM, such as Prokera® Slim, and dehydrated AM, such as AmbioDisk (See Mcgaughy et al, Pg 31, 2nd col-Pg 32, 2nd col 1).
Hopkinson disclose use of vacuum-dehydrated AM for treating ocular disorders and teach that it has benefits over cryopreserved AM. Hopkinson teaches freezing and subsequent thawing of the amniotic membrane (such as is required for cryopreserved AM and freeze-dried AM) damages the structure and/or cells in the amniotic membrane, which subsequently causes a loss in soluble factors. In contrast, vacuum-dried AM retains up to 100% of the soluble factors compared to fresh amniotic membrane (See Hopkinson Pg 10, ln 33-Pg 11, ln 27). Furthermore, cryopreserved AM releases all of its factors within 24 hrs, whereas a vacuum-dried membrane has more sustained release, over a period of up to more than 14 days. Hopkinson teaches the sustained release is advantageous (See Hopkinson, Pg 11, ln 29-Pg 12, ln 10). Hopkinson further teach the use of sutureless bandage contact lens (used in combination with the dAM) enhances patient comfort and treatment efficacy compared to the more rigid Prokera (See Hopkinson, Pg. 26, ln 16-Pg 27, ln 4).
Based on the advantages present with vacuum-dehydrated AM compared to cryopreserved AM, one would have been motivated to have substituted vacuum-dried AM taught by Hopkinson for the Prokera® Slim CAM in the method of Yeu et al. One would have had a reasonable expectation of success because Mcgaughy et al teach both cryopreserved and dehydrated AM are appropriate for in office use for treating ocular surface disorders, Hopkinson teach the dAM successfully improves ocular surface health, and Hopkinson provide detail on how to utilize the vacuum-dried (dehydrated) AM to treat ocular surface disorders.
Hopkinson is further relied upon to disclose details on how to specifically apply the vacuum-dried AM:
Hopkinson teach the dAM is applied to the subject’s eye, specifically the cornea, in combination with a contact lens. The dAM is applied to the subject’s eye, and a contact lens applied over the amniotic membrane to hold it in place. Alternatively, the dAM may be attached to or loaded to the contact lens, and then the combination dAM-contact lens is applied to the subject’s eye. The dAM is in direct contact with the subject’s eye (See Hopkinson, Pg 2, ln 11-17 & Fig. 1).
In the more detailed “Intervention” section, Hopkinson report placing the dAM disc onto the eye surface along with the bandage contact lens, and then assessing contact lens fit and dAM positioning using a digital slit lamp under 16x magnification and assessing dAM window-to-pupil centration using an anterior segment Optimal Coherence Tomographer (See Hopkinson, Pg 21, ln 5-21). Based on the guidance of Hopkinson, using the dAM of Hopkinson in place of the Prokera CAM in the method of Yeu et al, would involve:
placing the dAM (which is a sterile and dehydrated amniotic membrane) directly onto an ocular surface, and then covering the dAM with a contact lens, such that the dAM is positioned between the ocular surface and the contact lens and the contact lens serves to secure the dAM in position on the ocular surface (relevant to claim 1).
Alternatively, the dAM (sterile and dehydrated) can be placed inside a contact lens prior to application of the dAM (and contact lens) to the eye, and the combined membrane-and-contact lens unity is placed onto the eye such that the dAM directly contacts the cornea and the contact lens overlies the dAM (relevant to claim 32).
Then, following placement, using a digital slit lamp under magnification (which reads on capturing microscopic documentation) and an anterior segment OCT (which reads on capturing photographic documentation) to ensure the dAM is properly centered over the cornea.
Thus, modifying the method of Yeu et al to involve use of the dAM of Hopkinson, including the placement steps taught by Hopkinson, render obvious all limitations of claims 1, 8 and 32.
Regarding claim 3: Following the discussion of claim 1 above, neither Yeu et al nor Hopkinson teach smoothing the dAM onto the ocular surface with a surgical sponge. However, use of a surgical sponge would have been prima facie obvious selection of a suitable tool for performing the step of applying the dAM to an ocular surface.
Regarding claim 4: Following the discussion of claim 1 above, Yeu et al report on patient pain and discomfort as a tertiary outcome (See Yeu et al, Pg. 787, 1st paragraph). Thus, Yeu et al necessarily monitored for discomfort. For the reasons discussed above, Hopkinson teaches ensuring that the dAM remains correctly positioned on the eye.
Regarding claim 6: Yeu et al does not teach applying a second amniotic membrane if healing of the corneal (e.g. re-epithelialization of the cornea) is not complete. However, Hopkinson teach that the dAM can be replaced after 4-5 days, as replacement avoids dAM cloudiness due to accumulation of inflammatory coagulum (See Hopkinson Pg 21, ln 5-21). Furthermore, it is submitted that it would generally have been prima facie obvious to have removed the first amniotic membrane and applied a second ‘new’ amniotic membrane if corneal healing were not complete. This conclusion of obviousness is based on logic held by an artisan of ordinary skill. The claimed step is repeating application of treatment agent if the desired goal (re-epithelialization of cornea) was not achieved with the first treatment. One would have had a reasonable expectation of successfully repeating the application of the amniotic membrane because Hopkinson teach how to remove and apply new dAM to the ocular surface.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALLISON M FOX whose telephone number is (571)272-2936. The examiner can normally be reached M-F 10-6 EST.
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, Christopher Babic can be reached at 571-272-8507. 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.
/ALLISON M FOX/Primary Examiner, Art Unit 1633
