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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02 September 2026 has been entered.
DETAILED OFFICE ACTION
This Office Action is in response to the papers filed on 02 September 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, 103-111 and 118-123 have been examined on their merits.
WITHDRAWN REJECTIONS
The previous rejections have been withdrawn due to claim amendment.
NEW REJECTIONS
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, 103-111, 118 and 120-123 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 and Liu et al. (Update on amniotic membrane transplantation. Expert Rev Ophthalmol. 2010 Oct;5(5):645-661) 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 an “umbilical cord amniotic membrane (UCAM) or substantially isolated UCAM” as a fetal support ([0039] [0045]). Tseng teaches “umbilical cord amniotic membrane” (UCAM) means amniotic membrane derived from the umbilical cord. The UCAM has multiple layers: an epithelial layer; a basement membrane; a compact layer; a fibroblast layer; and a spongy layer. It lacks blood vessels or a direct blood supply” ([0045]).The instant specification does not define “essentially free”. Therefore an isolated and substantially isolated UCAM is broadly interpreted to be essentially free of Wharton’s Jelly.
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 dry eye ([0021]), corneal ulcers ([0059]), persistent epithelial defect ([0059]) and pterygium ([0059]) (ocular surface disorders). The art teaches fornix reconstruction ([0059]).
Because the product treats an ophthalmic disorder, it is interpreted to administer a therapeutically effective amount of HC-HA/PTX3.
Tseng is silent regarding the shape of the UCAM.
Tseng does not teach administering the fetal support tissue to an inferior fornix of the eye.
Liu teaches amniotic membrane has been successfully used as a graft for a wide range of ophthalmic indications (see last sentence of page 1 bridging first sentence of page 2). Figure 3 teaches application of an amniotic membrane “in ocular surface”. The art teaches amniotic membrane can be inserted “into the upper fornix first” (hence, superior fornix; see text under Figure 3).
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 in a superior fornix. One would have been motivated to do so to treat an ocular surface in a patient as taught by Liu. One would have had a reasonable expectation of success since Liu teaches an amniotic membrane can be inserted into the upper fornix of the eye. One would have expected similar results since Liu teaches amniotic membrane can be inserted into the fornix. One would have expected similar results since both references are directed to methods of treating ocular disorders. Therefore claim 99 is rendered obvious.
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.
Tseng teaches 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 regenerate 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.
Tseng teaches cutting AM tissues to a size of 2.0 cm×2.0 cm ([0228] [0231]) and 2.0 cm×3.0 cm ([0233]). This is interpreted to be a rectangular shape. Claim 123 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 Liu 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 02 September 2026 are acknowledged.
New grounds of rejection have been made to address the amended claims.
Conclusion
No claims are allowed.
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) 270-8439.
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/NATALIE M MOSS/ Examiner, Art Unit 1653
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