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U.S. Serial No.: 15/632,497
`Atty. Docket No.: GWLG-017US-CIP
`Response to Non-Final Office Action
`
`AMENDMENT TO THE CLAIMS
`
`This listing of claims will replace all prior versions, and listings, of claims in the
`
`application. The following amendments do not constitute an admission regarding the
`
`patentability of the amended subject matter and should not be so construed.
`
`Please amend the claims as follows:
`
`1.
`
`(Currently Amended) A method of diagnosing endometriosis in a mammal comprising the
`
`steps of:
`
`determining the circulatingexpressien—levels of BDNF; glycodelinrand—eptienaWG; in
`
`a '
`
`'
`
`plasma sample from the mammal by contacting the sample with a glycodelin antibody
`
`raised in a host animal,and
`
`comparing the level of glycodelineaeh to a pre-determined level associated with
`
`endometriosis; and
`
`diagnosing the mammal with endometriosis when the levels of BDNF; glycodelin and
`
`optional-lyLZArG—are—eaeh iselevated to the predetermined level associated with endometriosis.
`
`2.
`
`(Currently Amended) The method of claim 1, wherein the level of BDNF—asseeiated—with
`
`endemetriesis—is—SWWGFgreatefithfienglycodelin associated with endometriosis is 39
`
`ng/ml or greater . -
`
`3.
`
`(Currently Amended) The method of claim 1, wherein the circulating levels of ZAG and
`
`CA125 are also determined in the sample and compared to a pre-determined level associated with
`
`endometriosisBDNF—is—tetal—pl—asm—a—BDlSJF.
`
`4.
`
`(Currently Amended) The method of claim 1, wherein the circulating level of BDNF is
`
`mBDNFdetermined in the sample.
`
`EDC_LAW\ 1826206\1
`
`3
`
`

`

`U.S. Serial No.: 15/632,497
`Atty. Docket No.: GWLG-017US-CIP
`Response to Non-Final Office Action
`
`5.
`
`(Original) The method of claim 1, including the additional step of treating endometriosis
`
`in the mammal with pain medication, hormone therapy or surgery.
`
`6.
`
`(Original) The method of claim 5, wherein hormone therapy is selected from hormonal
`
`contraceptives, gonadotropin-releasing hormone (Gn-RH) agonists or antagonists optionally in
`
`combination with estrogen or progestin, progestin therapy, contraceptive implant, contraceptive
`
`injection and steroid treatment to suppress the growth of the endometrium.
`
`7.
`
`(Currently Amended) A method of monitoring a mammal
`
`following treatment of
`
`endometriosis comprising:
`
`determining the level of a—bimnafléeHeleeted—firem circulating BDNF—er glycodelin in a
`
`biological sample from the mammal by contacting the sample with a glycodelin antibody raised in
`
`a host animal and determing the level of glycodelin based on the level of antibody binding to
`
`glycodelin, and
`
`comparing the biemarkenlevel of glycodelin to a control pro-treatment biomarker level to
`
`determine if the glycodelin biemarkenlevel is elevated compared to the control level;
`
`and
`
`determining that the mammal is responding to treatment when the biemarkenglycodelin
`
`level is decreasing in comparison to the control level.
`
`8.
`
`(Currently Amended) A kit comprising a—BDNF—speei—fimetant; a glycodelin-specific
`
`reactant, a ZAG—specific reactant, and optionally a MZAG-specific reactant for use in a
`
`method to diagnose endometriosis in a mammalas—defined—in—elaim—l.
`
`9.
`
`(Original) The kit of claim 8, wherein the reactants are selected from a nucleic acid probe,
`
`an antibody or a substrate.
`
`10.
`
`(Original) The kit of claim 8, wherein the reactants are each associated with an indicator
`
`that yields a detectable signal when the reactants bind to their target biomarker.
`
`EDC_LAW\ 1826206\1
`
`4
`
`

`

`U.S. Serial No.: 15/632,497
`Atty. Docket No.: GWLG-017US-CIP
`Response to Non-Final Office Action
`
`11.
`
`(Original) The kit of claim 8, wherein the reactants are bound to a microchip.
`
`12.
`
`(Original) The kit of claim 8, wherein the reactants are bound to an electrochemical
`
`biochip.
`
`13.
`
`(New) A method of detecting the level of circulating glycodelin in a mammal comprising,
`
`detecting the presence of glycodelin in a plasma sample from the mammal by contacting
`
`the sample with an anti-glycodelin antibody;
`
`detecting binding between the antibody and glycodelin in the sample and determining the
`
`level of circulating glycodelin based on the amount of antibody binding.
`
`14.
`
`(New) The method of claim 13, additionally comprising detecting the presence and
`
`circulating levels of ZAG and CA125 in the sample by contacting the sample with anti-ZAG and
`
`anti-CA125 antibodies and determining the levels of each based on the amount of antibody
`
`binding.
`
`15.
`
`(New) The method of claim 13, additionally comprising detecting the presence and level
`
`of circulating BDNF in the sample by contacting the sample with an anti-BDNF antibody and
`
`determining the level of BDNF based on the amount of BDNF antibody binding.
`
`16.
`
`(New) The method of claim 15, additionally comprising detecting the presence and level
`
`of ZAG in the sample by contacting the sample with an anti-ZAG antibody and determining the
`
`circulating level of ZAG in the mammal based on the amount of antibody binding.
`
`17.
`
`(New) A method of determining levels of circulating BDNF and CA-125 in a mammal
`
`comprising:
`
`detecting the presence of BDNF and CA-125 in a plasma sample from the mammal by
`
`contacting the sample with an anti-BDNF antibody and an anti-CA-125 antibody;
`
`EDC_LAW\ 1826206\1
`
`5
`
`

`

`U.S. Sen'alNoz 15/632,497
`Atty. Docket No.: GWLG-017US-CIP
`Response to Non-Final Office Action
`
`detecting binding between the anti-BDNF antibody and BDNF and between the anti-CA-
`
`125 antibody and CA-125 in the sample; and
`
`determining the circulating levels of BDNF and CA-125 in the mammal based on the
`
`amount of antibody binding.
`
`EDC_LAW\ 1826206\1
`
`6
`
`

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