U.S. Sen'alNoz 15/632,497
`Atty. Docket No.: GWLG-017US-CIP
`Response to Final Off1ce 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 and treating endometriosis in a mammal
`
`comprising the steps of:
`
`
`detectingdetermi—ni—ng—the circulating levels of glycodelin and one or more of BDNF
`
`ZAG and CA125 in a plasma sample from the mammal by contacting the sample with a
`
`glycodelin antibody and an antibody to one or more of BDNF, ZAG and CA125, detecting
`
`binding between glycodelin and one or more of BDNF, ZAG and CA125 and determining
`
`circulating levels thereof based on the amount of antibody bindingraised—in—a—hest—animal,
`
`
`comparing the level of glycodelin and one or more of BDNF ZAG and CA125 to
`
`a pre-determined level associated with endometriosis; and
`
`
`diagnosing the mammal with endometriosis when the levels of glycodelin and one
`
`
`or more of BDNF ZAG and CA125 is elevated to the predetermined level associated with
`
`endometriosis, and
`
`treating the mammal with at least one of a pain medication, hormone therapy, a
`
`gonadotropin-releasing hormone an-RH) agonist or antagonist to block the production of
`
`ovarian-stimulating hormones, progestin therapy, or steroid treatment to suppress the
`
`growth of the endometrium.
`
`
`Atty. Docket No.: GWLG-017US-CIP
`Response to Final Off1ce 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 and treating endometriosis in a mammal
`
`comprising the steps of:
`
`
`detectingdetermi—ni—ng—the circulating levels of glycodelin and one or more of BDNF
`
`ZAG and CA125 in a plasma sample from the mammal by contacting the sample with a
`
`glycodelin antibody and an antibody to one or more of BDNF, ZAG and CA125, detecting
`
`binding between glycodelin and one or more of BDNF, ZAG and CA125 and determining
`
`circulating levels thereof based on the amount of antibody bindingraised—in—a—hest—animal,
`
`
`comparing the level of glycodelin and one or more of BDNF ZAG and CA125 to
`
`a pre-determined level associated with endometriosis; and
`
`
`diagnosing the mammal with endometriosis when the levels of glycodelin and one
`
`
`or more of BDNF ZAG and CA125 is elevated to the predetermined level associated with
`
`endometriosis, and
`
`treating the mammal with at least one of a pain medication, hormone therapy, a
`
`gonadotropin-releasing hormone an-RH) agonist or antagonist to block the production of
`
`ovarian-stimulating hormones, progestin therapy, or steroid treatment to suppress the
`
`growth of the endometrium.
`
`
`
`U.S. Sen'alNoz 15/632,497
`Atty. Docket No.: GWLG-017US-CIP
`Response to Final Office Action
`
`(Previously Presented) The method of claim 1, wherein the level of glycodelin associated
`
`with endometriosis is 39 ng/ml or greater.
`
`(Previously Presented) 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 endometriosis.
`
`(Previously Presented) The method of claim 1, wherein the circulating level of BDNF is
`
`determined in the sample.
`
`(Currently Amended) The method of claim 1, wherein circulating levels of ZAG and
`
`BDNF are determinedmemdmg—the—addifiemfl—Eep—efireatmg—endenmme
`
`
`
`(Currently Amended) The method of claim 15, wherein enzyme-linked immunosorbent
`
`assay is used to detect circulating levels of glycodelin and one or more of BDNF, ZAG and
`
`
`
`(Cancel)
`
`(Currently Amended) A kit comprising a glycodelin-specific reactant, and one or more of
`
`a ZAG-specific reactant, and—optionally a BDNF-specific reactant and a CA-lZS-specific
`
`
`reactant for use in a method to diagnose endometriosis in a mammal.
`
`(Original) The kit of claim 8, wherein the reactants are selected from a nucleic acid probe,
`
`an antibody or a substrate.
`
`
`
`US. Serial No.: 15/632,497
`Atty. Docket No.: GWLG-017US-CIP
`Response to Final Office Action
`
`10.
`
`ll.
`
`12.
`
`l3.
`
`(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.
`
`(Original) The kit of claim 8, wherein the reactants are bound to a microchip.
`
`(Original) The kit of claim 8, wherein the reactants are bound to an electrochemical
`
`biochip.
`
`(Currently Amended) A method—efideteeting—the—level—efieireulating—glyeedelin—in—a
`
`mammal—comprising;
`
`contacting a sample from a mammal with a glycodelin antibody and an antibody to
`
`one or more of BDNF ZAG and CA-125'
`
`
`
`detecting binding between the glycodelin antibody and glycodelin and between the
`
`antibody to one or more of BDNF, ZAG and CA-125 and one or more of BDNF, ZAG and
`
` CA-125, respectively;
`'
`
`1
`
`l
`
`l
`
`E
`
`'l
`
`l
`
`l
`
`.
`
`l'
`
`determining levels of glycodelin and one or more of BDNF, ZAG CA-125 in the
`
`sample based on the antibody binding; and
`
`comparing the levels of glycodelin and one or more of BDNF, ZAG CA-125 with
`
`predetermined levels of glycodelin and one or more of BDNF, ZAG and CA-125, wherein
`
`the predetermined levels are associated with endometriosis.
`
`14.
`
`(Currently Amended) The method of claim 13, admmflybeemprrsmg—deteeH-ng—the
`
`presenee—and—ei—reul—ati—ng wherein levels of ZAG and CA125 are determined in the sample
`
`
`
`US. Sen'alNoz 15/632,497
`Atty. Docket No.: GWLG-017US-CIP
`Response to Final Office Action
`
`
`
`(Currently Amended) The method of claim 13, admaflybeenrprwfiig—deteetmg—the
`
`presenee—and wherein the level of circulating BDNF is determined in the sample—byL
`
`
`
`(Currently Amended) The method of claim 15, admaflybeernprwfiig—deteetmg—the
`
`presenee—and wherein the level of ZAG is determined in the sample—byheentaeti-ng—the
`
`
`
`(Previously presented) A method of determining levels of circulating BDNF and CA-125
`
`15.
`
`l6.
`
`17.
`
`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;
`
`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.
`
`
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