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 .
DETAILED OFFICE ACTION
This Office Action is in response to the papers filed on 23 March 2026.
PRIORITY
Provisional Application 63/004987, filed on 03 April 2020, is acknowledged. The Provisional Application does not disclose a superior fornix. PCT/US2021/025642 discloses an inferior fornix and a superior fornix.
CLAIMS UNDER EXAMINATION
Claims 99, 102-111 and 118-122 have been examined on their merits.
WITHDRAWN REJECTIONS
The previous rejections have been withdrawn due to claim amendment.
NEW REJECTIONS
New grounds of rejection have been necessitated by claim amendment.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 99, 102-111, 118 and 120-122 are rejected under 35 U.S.C. 103 as being unpatentable over Tseng et al. Methods of Sterilizing Fetal Support Tissues. US20150335771) in view of Solomon et al. (Amniotic membrane transplantation for reconstruction of the conjunctival fornices. Ophthalmology et al. Volume 110, Issue 1, January 2003, Pages 93-100) as evidenced by Cambridge Dictionary (definition of the term “layer”).
Tseng teaches methods of making and using a fetal support tissue product (Abstract; [0003]). Tseng teaches the following ([0039]):
Examples fetal support tissue products include, but are not limited to, (i) placental amniotic membrane (PAM), or substantially isolated PAM, (ii) umbilical cord amniotic membrane (UCAM) or substantially isolated UCAM, (iii) chorion or substantially isolated chorion, (iv) amnion-chorion or substantially isolated amnion-chorion, (v) placenta or substantially isolated placenta, (vi) umbilical cord or substantially isolated umbilical cord, or (vii) any combinations thereof.
Therefore the product can be a umbilical cord amniotic membrane (UCAM). Tseng teaches the amniotic membrane is a layer ([0002]). A layer is a sheet (as evidenced by Cambridge Dictionary). Tseng teaches HC-HA/PTX3 complex (which comprises Petraxin 3 (PTX3) is present in amniotic membrane (see [0226] [0229]; Table 12).
Tseng teaches the product can be used to treat an ophthalmic disorder in an individual ([0021]). In some embodiments, the ophthalmic disorder is a wound or dry eye ([0021]). Because the product treats an ophthalmic disorder, it is interpreted to administer a therapeutically effective amount of HC-HA/PTX3.
Tseng does not teach applying the fetal support tissue to an inferior fornix of the eye.
Solomon et al. teach amniotic membrane transplantation (AMT) for fornix reconstruction in a variety of ocular surface disorders (see “Purpose” of Abstract on page 93). Figure 1 discloses amniotic membrane transplantation for reconstruction of the lower fornix (inferior fornix). The art treats subjects with damaged inferior fornix (see Case 3 beginning on page 96). Fornix reconstruction is performed by AMT (see page 98, left column, first paragraph).
It would have been obvious to use UCAM to treat an ocular surface disease, disorder and/or wound. KSR Rationale E indicates that “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and commonsense” (MPEP 2143 “Rationale E. Obvious to Try” section). One would have been motivated to do so since Tseng teaches UCAM comprises HC-HA/PTX3, which has anti-inflammatory and anti-scarring actions (Example 2). One would have had a reasonable expectation of success since Tseng teaches UCAM can be used as a fetal tissue product for treating an ocular disorder.
It would have been obvious to apply the amniotic membrane taught by Tseng to an inferior fornix. One would have been motivated to do so to reconstruct the inferior fornix in an patient with an ocular disease. One would have had a reasonable expectation of success since Solomon teaches an amniotic membrane can be transplanted to reconstruct the lower (inferior) fornix. One would have expected similar results since Solomon teaches amniotic membrane can be applied to the fornix. Therefore claim 99 is rendered obvious.
The UCAM can comprise Wharton’s Jelly ([0045]). Claim 102 is rejected.
The product may be lyophilized ([0039]). Claim 103 is rejected.
Tseng teaches the product can be frozen, which kills substantially all cells found in the fetal support product ([0121]). Therefore claims 104-106 are rendered obvious.
The tissue product lacks blood vessels ([0045]). Therefore claim 107 is rejected.
Tseng teaches cryopreservation ([0060]). Therefore claim 108 is included in this rejection.
The product may be lyophilized ([0039]). Claim 109 is rejected.
The product can be used to regenerate or repair nerve ([0019]). Because the art teaches UCAM, it would inherently rengeite nerve when applied to the eye. Therefore claim 110 is included in this rejection.
Exemplary properties or therapeutic activities of the product include, but are not limited to, anti-inflammation, anti-scarring, anti-adhesion, wound healing or tissue regeneration ([0114]). Therefore claim 111 is included in this rejection.
Tseng teaches treating Stevens Johnson Syndrome ([0059]). Therefore claim 118 is included in this rejection.
Tseng teaches treating an ophthalmic wound ([0021]) Therefore claim 120 is rejected. A wound is interpreted to be an injury. Therefore claim 121 is included in this rejection.
Exemplary properties or therapeutic activities of the product include, but are not limited to, anti-inflammation, anti-scarring, anti-adhesion, wound healing or tissue regeneration ([0114]). Therefore claim 122 is included in this rejection.
Therefore Applicant’s invention is rendered obvious as claimed.
Claim 119 is rejected under 35 U.S.C. 103 as being unpatentable over Tseng in view of Solomon as applied to claim 118 above, and further in view of Tseng et al. (Compositions Containing HC-HA Complex and Methods of Use Thereof. US20120083445).
Claim 118 is rejected on the ground set forth above. The teachings of Tseng are reiterated. Tseng teaches the use of a composition comprising an HC-HA complex. Tseng teaches treating ocular diseases and disorders. Tseng does not teach treating pemphigoid.
Tseng (2012) teaches compositions comprising an HC-HA complex from amniotic material ([0010]). The art teaches administration to an eye ([0148]). The composition can be used to treat bullous pemphigoid ([0069]).
It would have been obvious to try treating pemphigoid with the UCAM taught by Tseng. One would have been motivated to do so since Tseng (2012) teaches amniotic HC-HA can be used to treat pemphigoid. One would have had a reasonable expectation of success since Tseng (2012) teaches amniotic HC-HA can be used to treat pemphigoid. One would have expected similar results since both references are directed to compositions comprising HC-HA complex for treating ocular conditions. Therefore claim 119 is included in this rejection.
Therefore Applicant’s Invention is rendered obvious as claimed.
RESPONSE TO APPLICANT’S ARGUMENTS
The arguments made in the response filed on 23 March 2026 are acknowledged.
Argument 1: The Applicant argues Tseng does not teach application to the superior or inferior fornix.
Response to Argument 1: New grounds of rejection have been made to address this limitation.
Argument 2: The arguments state Tseng does not teach an umbilical cord amniotic membrane sheet.
Response to Argument 2: Tseng teaches the amniotic membrane is a layer ([0002]). As evidenced by Cambridge Dictionary, a layer is defined as a “thin sheet”. A layer is interpreted to be a sheet. Therefore the argument is not persuasive.
CONCLUSION
No Claims Are Allowed
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATALIE MOSS whose telephone number is (571) 270-7439. The examiner can normally be reached on Monday-Friday, 8am-5pm EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila Landau can be reached on (571) 272-0614. The fax phone number for the organization where this application or proceeding 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 applications 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 APIR 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 Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/NATALIE M MOSS/ Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653