DETAILED ACTION
The present application is being examined under the pre-AIA first to invent provisions. This Office Action is non-final.
Request for Reconsideration
Applicant's reply filed 2/26/2026 has been entered. The claims were not amended. Claims 1 and 3-20 remain pending, of which claims 1, 3-5, and 18 are being considered on their merits. Claims 6-17, 19, and 20 remain withdrawn from consideration. References not included with this Office action can be found in a prior action. Any rejections of record not particularly addressed below are withdrawn in light of the claim amendments and/or applicant’s comments.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1, 3-5, and 18 are rejected under 35 U.S.C. 103(a) as being unpatentable over in view of Chan et al. (US 2005/0059013) in view of Lokshin et al. (US 2007/0042405; provided in the IDS dated 2/21/2020) and Chan et al. (US 2005/0214760).
The ‘013 pre-grant publication of Chan teaches methods of detecting ovarian cancer (Abstract). The ‘013 pre-grant publication of Chan teaches CA125, Apo A1, and HE4 as exemplary ovarian cancer markers (¶0018, ¶0109), reading in-part the elected species of claim 1 element (b). The ‘013 pre-grant publication of Chan teaches a solid support derivatized with (or otherwise attached to) a capture reagent (¶0061, ¶0128-0131, and ¶0138), reading on claims 1 and 18. Chan teaches using antibodies to detect the biomarkers of interest (¶0197), reading on claim 1, 3, 4, and 18. Chan teaches a test kit (¶0037), reading on claim 5. Chan teaches a multianalyte panel assay comprising at least two biomarkers (¶0229-0230), reading on claim 18.
Regarding claims 1 and 18, the ‘013 pre-grant publication of Chan does not teach the elected combination of biomarkers comprising further comprising FSH and transferrin. Regarding claims 1 and 18, the ‘013 pre-grant publication of Chan does not teach the embodiment of biomarkers further comprising interleukin-8 (i.e. IL-8 or CXCL8), leptin (i.e. LEP), macrophage inflammatory protein 1 alpha (i.e. MIP-1α or CCl3), and/or tumor necrosis factor alpha (i.e. TNFα or TNF).
Lokshin teaches methods of detecting biomarkers in the serum of subjects to then determine if said subjects have ovarian cancer (Abstract). Lokshin teaches a set of antibody reagents to measure the levels of biomarkers: CA125, HE4 and FSH (page 2, ¶0014, line 5++); wherein the reagents are binding molecules because the serum the biomarkers are detected by perspective antibodies, and reading in-part on claims 1, 3-5, and 18. Lokshin teaches biomarkers for detecting ovarian cancer comprising interleukin-8, leptin (i.e. LEP), macrophage inflammatory protein 1 alpha and/or tumor necrosis factor alpha and detecting said biomarkers with antibodies (¶0012, see “anti-“, ¶0016), reading in-part on claim 1 element (b) and on claim 18.
The ‘760 pre-grant publication of Chan teaches methods of detecting ovarian cancer (Abstract). The ‘760 pre-grant publication of Chan teaches transferrin as an exemplary biomarker (¶0011-0015), reading on claims 1 and 18. Chen teaches using antibodies to detect the biomarkers of interest (¶0139), reading on claims 1 and 18.
Regarding claims 1 and 18, it would have been obvious to a person of ordinary skill in the art before the invention was filed to add the FSH antibody and one or more of the interleukin 8, leptin, macrophage inflammatory protein 1 alpha, and tumor necrosis factor alpha antibodies taught by the Lokshin and the transferrin antibody of the ‘760 pre-grant publication teachings to Chan to the composition and solid support of ‘013 pre-grant publication teachings to Chan. A person of ordinary skill in the art would have had a reasonable expectation of success to do so because Lokshin and both teachings to Chan are directed towards biomarkers for detecting ovarian cancer, and because all three references teach or envision antibodies as an exemplary species of compound capable of detecting the biomarkers of interest. The skilled artisan would have been motivated to do so because the addition would predictably enhance the composition and solid support of ‘013 pre-grant publication teachings to Chan for its intended use of detecting the biomarkers to determine if the subjects have ovarian cancer.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
Claims 1, 3-5, and 18 are rejected under 35 U.S.C. 103(a) as being unpatentable over in view of Chan et al. (US 2005/0059013) in view of Lokshin et al. (US 2007/0042405; provided in the IDS dated 2/21/2020).
Other species were found during the search. This rejection addresses the embodiment of claim 1 (f) comprising CA125, ApoA1, the narrower embodiment of transthyretin comprising truncated transthyretin ΔN10, and FSH and further comprising one or more of comprising interleukin-8 (i.e. IL-8 or CXCL8), leptin (i.e. LEP), macrophage inflammatory protein 1 alpha (i.e. MIP-1α or CCl3), and/or tumor necrosis factor alpha (i.e. TNFα or TNF).
The ‘013 pre-grant publication of Chan teaches methods of detecting ovarian cancer (Abstract). The ‘013 pre-grant publication of Chan teaches CA125, Apo A1, and transthyretin as exemplary ovarian cancer markers (¶0017-0018, ¶0109), reading in-part on claim 1 element (f). The ‘013 pre-grant publication of Chan teaches a solid support derivatized with (or otherwise attached to) a capture reagent (¶0061, ¶0128-0131, and ¶0138), reading on claims 1 and 18. Chan teaches using antibodies to detect the biomarkers of interest (¶0197), reading on claim 1, 3, 4, and 18. Chan teaches a test kit (¶0037), reading on claim 5. Chan teaches a multianalyte panel assay comprising at least two biomarkers (¶0229-0230), reading on claim 18.
Regarding claims 1 and 18, the ‘013 pre-grant publication of Chan does not teach the combination of biomarkers comprising further comprising FSH. Regarding claims 1 and 18, the ‘013 pre-grant publication of Chan does not teach the embodiment of biomarkers further comprising interleukin-8 (i.e. IL-8 or CXCL8), leptin (i.e. LEP), macrophage inflammatory protein 1 alpha (i.e. MIP-1α or CCl3), and/or tumor necrosis factor alpha (i.e. TNFα or TNF).
Lokshin teaches methods of detecting biomarkers in the serum of subjects to then determine if said subjects have ovarian cancer (Abstract). Lokshin teaches a set of antibody reagents to measure the levels of biomarkers: CA125 and FSH (page 2, ¶0014, line 5++); wherein the reagents are binding molecules because the serum the biomarkers are detected by perspective antibodies, and reading in-part on claims 1, 3-5, and 18. Lokshin teaches biomarkers for detecting ovarian cancer comprising interleukin-8, leptin (i.e. LEP), macrophage inflammatory protein 1 alpha and/or tumor necrosis factor alpha and detecting said biomarkers with antibodies (¶0012, see “anti-“, ¶0016), reading in-part on claim 1 element (b) and on claim 18.
Regarding claims 1 and 18, it would have been obvious to a person of ordinary skill in the art before the invention was filed to add the FSH antibody and one or more of the interleukin 8, leptin, macrophage inflammatory protein 1 alpha, and tumor necrosis factor alpha antibodies taught by the Lokshin antibodies taught by the Lokshin to the composition and solid support of ‘013 pre-grant publication teachings to Chan. A person of ordinary skill in the art would have had a reasonable expectation of success to do so because Lokshin and Chan are directed towards biomarkers for detecting ovarian cancer, and both references teach or envision antibodies as an exemplary species of compound capable of detecting the biomarkers of interest. The skilled artisan would have been motivated to do so because the addition would predictably enhance the composition and solid support of ‘013 pre-grant publication teachings to Chan for its intended use of detecting the biomarkers to determine if the subjects have ovarian cancer.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 3-5, and 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 10,605,811 (provided in the IDS dated 5/26/2023) in view of Chan et al. (US 2005/0214760) and Lokshin et al. (US 2007/0042405; provided in the IDS dated 2/21/2020), and Chan et al. (US 2005/0059013).
Claim 1 of the ‘811 patent claims an article of manufacture comprising a set of reagents to measure the levels of a panel of biomarkers in a specimen, wherein the panel of biomarkers comprise CA125, Apo A1, HE4, and FSH, and their measurable fragments, and wherein the set of reagents are bound to a solid support and specifically bind to said biomarkers, reading in-part on instant claim 1. Claim 2 of the ‘811 patent further claims wherein the reagents are binding molecules, reading on instant claim 3. Claim 3 of the ‘811 patent further claims wherein the binding molecules are antibodies, reading on instant claim 4. Claim 4 of the ‘811 patent claims a test kit comprising the set of reagents of claim 1, reading on instant claim 5. Claim 5 of the ‘811 patent claims a multianalyte panel assay comprising the set of reagents of claim 1, reading on instant claim 18.
Regarding claim 1 (b) and (f), the ‘811 patent does not further claim the elected species of transferrin and the embodiments of biomarkers further comprising interleukin-8 (i.e. IL-8 or CXCL8), leptin (i.e. LEP), macrophage inflammatory protein 1 alpha (i.e. MIP-1α or CCl3), and/or tumor necrosis factor alpha (i.e. TNFα or TNF). Regarding claim (f), the ‘811 patent does not further claim transthyretin.
The ‘070 pre-grant publication of Chan teaches methods of detecting ovarian cancer (Abstract). The ‘070 pre-grant publication of Chan teaches transferrin as an exemplary biomarker (¶0011-0015), reading on claim 1. Chan teaches using antibodies to detect the biomarkers of interest (¶0139), reading on claim 1.
The ‘013 pre-grant publication of Chan teaches methods of detecting ovarian cancer (Abstract). The ‘013 pre-grant publication of Chan teaches CA125, Apo A1, and transthyretin as exemplary ovarian cancer markers (¶0017-0018, ¶0109), reading in-part on claim 1 element (f). The ‘013 pre-grant publication of Chan teaches a solid support derivatized with (or otherwise attached to) a capture reagent (¶0061, ¶0128-0131, and ¶0138), reading on claims 1 and 18. Chan teaches using antibodies to detect the biomarkers of interest (¶0197), reading on claim 1.
Lokshin teaches methods of detecting biomarkers in the serum of subjects to then determine if said subjects have ovarian cancer (Abstract). Lokshin teaches a set of antibody reagents to measure the levels of biomarkers: CA125, HE4 and FSH (page 2, ¶0014, line 5++); wherein the reagents are binding molecules because the serum the biomarkers are detected by perspective antibodies, and reading in-part on claims 1, 3-5, and 18. Lokshin teaches biomarkers for detecting ovarian cancer comprising interleukin-8, leptin (i.e. LEP), macrophage inflammatory protein 1 alpha and/or tumor necrosis factor alpha and detecting said biomarkers with antibodies (¶0012, see “anti-“, ¶0016), reading in-part on claim 1 (b) and (f).
Regarding claim 1 (b) and (f), it would have been obvious to a person of ordinary skill in the art before the invention was filed to add the transferrin or transthyretin, and further add one or more of interleukin-8, leptin, MIP-1α, and TNFα antibodies envisioned by two pre-grant publications of Chan and Lokshin to the article of manufacture of the ‘811 patent. A person of ordinary skill in the art would have had a reasonable expectation of success to do so because both teachings of Chan, Lokshin, and the ‘811 patent are directed towards articles comprising reagents capable of detecting biomarkers. The skilled artisan would have been motivated to do so because the addition would predictably enhance the composition and solid support of ‘811 patent for the downstream use of detecting the biomarkers to determine if the subjects have ovarian cancer in view of Chan and Lokshin.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
Claims 1, 3-5, and 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 9,846,158 (provided in the IDS dated 2/21/2020) in view of Chan et al. (US 2005/0214760) and Lokshin et al. (US 2007/0042405; provided in the IDS dated 2/21/2020).
Claim 1 (e) and (g)-(i) of the ‘158 patent claims a set of reagents to measure the levels of a panel of biomarkers in a specimen, wherein the panel of biomarkers comprise CA125, Apo A1, HE4, FSH, and transferrin, and their measurable fragments, reading in-part on instant claim 1 (b). Claim 1 (j)-(l) of the ‘158 patent claims a set of reagents to measure the levels of a panel of biomarkers in a specimen, wherein the panel of biomarkers comprise CA125, Apo A1, transthyretin, and FSH, and their measurable fragments, reading in-part on instant claim 1 (f). Claim 2 of the ‘158 patent further claims wherein the reagents are binding molecules, reading on instant claim 3. Claim 3 of the ‘158 patent further claims wherein the binding molecules are antibodies, reading on instant claim 4. Claim 4 of the ‘158 patent claims a test kit comprising the set of reagents of claim 1, reading on instant claim 5. Claim 5 of the ‘158 patent claims a multianalyte panel assay comprising the set of reagents of claim 1, reading on instant claim 18.
Regarding claim 1, the ‘158 patent does not claim any generic article of manufacture. Regarding claim 1 (b) and (f), the ‘158 patent does not further claim the embodiments of biomarkers further comprising interleukin-8 (i.e. IL-8 or CXCL8), leptin (i.e. LEP), macrophage inflammatory protein 1 alpha (i.e. MIP-1α or CCl3), and/or tumor necrosis factor alpha (i.e. TNFα or TNF).
Chan teaches methods of detecting ovarian cancer (Abstract). Chan teaches using antibodies to detect the biomarkers of interest (¶0139), reading on claim 1. Chan teaches using antibodies to detect the biomarkers of interest (¶0139) on a solid support to facilitate washing and subsequent isolation of the complex prior to contacting the antibody with a sample (¶0136), reading on the article of manufacture of claim 1.
Lokshin teaches methods of detecting biomarkers in the serum of subjects to then determine if said subjects have ovarian cancer (Abstract). Lokshin teaches a set of antibody reagents to measure the levels of biomarkers: CA125, HE4 and FSH (page 2, ¶0014, line 5++); wherein the reagents are binding molecules because the serum the biomarkers are detected by perspective antibodies, and reading in-part on claims 1, 3-5, and 18. Lokshin teaches biomarkers for detecting ovarian cancer comprising interleukin-8, leptin (i.e. LEP), macrophage inflammatory protein 1 alpha and/or tumor necrosis factor alpha and detecting said biomarkers with antibodies (¶0012, see “anti-“, ¶0016), reading in-part on claim 1 (b) and (f).
Regarding the preamble of claim 1, it would have been obvious to a person of ordinary skill in the art before the invention was filed to add the article of manufacture of Chan to the reagent set of the ‘158 patent. A person of ordinary skill in the art would have had a reasonable expectation of success to do so because Chan and the ‘158 patent are in-part directed towards antibodies capable of detecting biomarkers. The skilled artisan would have been motivated to do so because the addition of a solid support would predictably enhance the composition the ‘158 patent for the downstream use of detecting the biomarkers to determine if the subjects have ovarian cancer in view of Chan and Lokshin and to facilitate washing and subsequent isolation of the complex prior to contacting the antibody with a sample as taught by Chan.
Regarding claim 1 (b) and (f), It would have been obvious to a person of ordinary skill in the art before the invention was filed to add the interleukin-8, leptin, MIP-1α, and TNFα antibodies of Lokshin to the reagent set and article of manufacture of the ‘158 patent in view of Chan. A person of ordinary skill in the art would have had a reasonable expectation of success to do so because Chan, Lokshin, and the ‘158 patent are directed towards reagents capable of detecting biomarkers. The skilled artisan would have been motivated to do so because the addition would predictably enhance the composition the ‘158 patent for the downstream use of detecting the biomarkers to determine if the subjects have ovarian cancer in view of Chan and Lokshin.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
Claims 1, 3-5, and 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 9,274,118 (provided in the IDS dated 2/21/2020) in view of Chan et al. (US 2005/0059013) and Lokshin et al. (US 2007/0042405; provided in the IDS dated 2/21/2020).
Claim 1 (n)-(o) and (dd) of the ‘118 patent claims a set of reagents to measure the levels of a panel of biomarkers in a specimen, wherein the panel of biomarkers comprise CA125 and Apo A1, and their measurable fragments, reading in-part on instant claim 1 (b) and (f). Claim 2 of the ‘118 patent further claims wherein the reagents are binding molecules, reading on instant claim 3. Claim 3 of the ‘118 patent further claims wherein the binding molecules are antibodies, reading on instant claim 4. Claim 4 of the ‘118 patent claims a test kit comprising the set of reagents of claim 1, reading on instant claim 5. Claim 5 of the ‘118 patent claims a multianalyte panel assay comprising the set of reagents of claim 1, reading on instant claim 18.
Regarding claim 1, the ‘118 patent does not claim any generic article of manufacture. Regarding claim 1 (b), the ‘118 patent does not further claim HE4, FSH, and transferrin and the embodiments of biomarkers further comprising interleukin-8 (i.e. IL-8 or CXCL8), leptin (i.e. LEP), macrophage inflammatory protein 1 alpha (i.e. MIP-1α or CCl3), and/or tumor necrosis factor alpha (i.e. TNFα or TNF). Regarding claim 1(f), the ‘118 patent does not further claim FSH and transthyretin transferrin and the embodiments of biomarkers further comprising interleukin-8 (i.e. IL-8 or CXCL8), leptin (i.e. LEP), macrophage inflammatory protein 1 alpha (i.e. MIP-1α or CCl3), and/or tumor necrosis factor alpha (i.e. TNFα or TNF).
Chan teaches methods of detecting ovarian cancer (Abstract). Chan teaches using antibodies to detect the biomarkers of interest (¶0142), reading on claim 1. Chan teaches using antibodies to detect the biomarkers of interest (¶0142) on a solid support to facilitate washing and subsequent isolation of the complex prior to contacting the antibody with a sample (¶0138), reading on the article of manufacture of claim 1. Chan teaches detecting a truncated form of transthyretin, ΔN10 (¶0017, and being the narrower embodiment of “transthyretin”), reading on claim 1(f).
Lokshin teaches methods of detecting biomarkers in the serum of subjects to then determine if said subjects have ovarian cancer (Abstract). Lokshin teaches a set of antibody reagents to measure the levels of biomarkers: CA125, HE4 and FSH (page 2, ¶0014, line 5++); wherein the reagents are binding molecules because the serum the biomarkers are detected by perspective antibodies, and reading in-part on claim 1 (b) and (f), and on claims 3-5 and 18. Lokshin teaches biomarkers for detecting ovarian cancer comprising interleukin-8, leptin (i.e. LEP), macrophage inflammatory protein 1 alpha and/or tumor necrosis factor alpha and detecting said biomarkers with antibodies (¶0012, see “anti-“, ¶0016), reading in-part on claim 1 element (b).
Regarding the preamble of claim 1, it would have been obvious to a person of ordinary skill in the art before the invention was filed to add the article of manufacture of Chan to the reagent set of the ‘118 patent. A person of ordinary skill in the art would have had a reasonable expectation of success to do so because Chan and the ‘118 patent are in-part directed towards antibodies capable of detecting biomarkers. The skilled artisan would have been motivated to do so because the addition of a solid support would predictably enhance the composition the ‘118 patent for the downstream use of detecting the biomarkers to determine if the subjects have ovarian cancer in view of Chan and Lokshin and to facilitate washing and subsequent isolation of the complex prior to contacting the antibody with a sample as taught by Chan.
Regarding claim 1 (b) and (f), It would have been obvious to a person of ordinary skill in the art before the invention was filed to add the HE4, FSH, and transferrin or transthyretin and FSH and further comprising interleukin-8, leptin, MIP-1α, and TNFα antibodies of Lokshin and Chan to the reagent set and article of manufacture of the ‘118 patent in view of Chan. A person of ordinary skill in the art would have had a reasonable expectation of success to do so because Chan, Lokshin, and the ‘158 patent are directed towards reagents capable of detecting biomarkers. The skilled artisan would have been motivated to do so because the addition would predictably enhance the composition the ‘158 patent for the downstream use of detecting the biomarkers to determine if the subjects have ovarian cancer in view of Chan and Lokshin.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
Claims 1, 3-5, and 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 8,664,358 (provided in the IDS dated 2/21/2020) in view of Chan et al. (US 2005/0059013) and Lokshin et al. (US 2007/0042405; provided in the IDS dated 2/21/2020).
Claim 1 (a), (b), and (i) of the ‘358 patent claims a set of reagents to measure the levels of a panel of biomarkers in a specimen, wherein the panel of biomarkers comprise CA125 and Apo A1, and their measurable fragments, reading in-part on instant claim 1 (b) and (f). Claim 2 of the ‘358 patent further claims wherein the reagents are binding molecules, reading on instant claim 3. Claim 3 of the ‘358 patent further claims wherein the binding molecules are antibodies, reading on instant claim 4. Claim 4 of the ‘358 patent claims a test kit comprising the set of reagents of claim 1, reading on instant claim 5. Claim 5 of the ‘358 patent claims a multianalyte panel assay comprising the set of reagents of claim 1, reading on instant claim 18.
Regarding claim 1, the ‘358 patent does not claim any generic article of manufacture. Regarding claim 1 (b), the ‘358 patent does not further claim HE4, FSH, and transferrin and the embodiments of biomarkers further comprising interleukin-8 (i.e. IL-8 or CXCL8), leptin (i.e. LEP), macrophage inflammatory protein 1 alpha (i.e. MIP-1α or CCl3), and/or tumor necrosis factor alpha (i.e. TNFα or TNF). Regarding claim 1(f), the ‘358 patent does not further claim FSH and transthyretin and the embodiments of biomarkers further comprising interleukin-8 (i.e. IL-8 or CXCL8), leptin (i.e. LEP), macrophage inflammatory protein 1 alpha (i.e. MIP-1α or CCl3), and/or tumor necrosis factor alpha (i.e. TNFα or TNF).
Chan teaches methods of detecting ovarian cancer (Abstract). Chan teaches using antibodies to detect the biomarkers of interest (¶0142), reading on claim 1. Chan teaches using antibodies to detect the biomarkers of interest (¶0142) on a solid support to facilitate washing and subsequent isolation of the complex prior to contacting the antibody with a sample (¶0138), reading on the article of manufacture of claim 1. Chan teaches detecting a truncated form of transthyretin, ΔN10 (¶0017, and being the narrower embodiment of “transthyretin”), reading on claim 1(f).
Lokshin teaches methods of detecting biomarkers in the serum of subjects to then determine if said subjects have ovarian cancer (Abstract). Lokshin teaches a set of antibody reagents to measure the levels of biomarkers: CA125, HE4 and FSH (page 2, ¶0014, line 5++); wherein the reagents are binding molecules because the serum the biomarkers are detected by perspective antibodies, and reading in-part on claim 1 (b) and (f), and on claims 3-5 and 18. Lokshin teaches biomarkers for detecting ovarian cancer comprising interleukin-8, leptin (i.e. LEP), macrophage inflammatory protein 1 alpha and/or tumor necrosis factor alpha and detecting said biomarkers with antibodies (¶0012, see “anti-“, ¶0016), reading in-part on claim 1 element (b).
Regarding the preamble of claim 1, it would have been obvious to a person of ordinary skill in the art before the invention was filed to add the article of manufacture of Chan to the reagent set of the ‘358 patent. A person of ordinary skill in the art would have had a reasonable expectation of success to do so because Chan and the ‘358 patent are in-part directed towards antibodies capable of detecting biomarkers. The skilled artisan would have been motivated to do so because the addition of a solid support would predictably enhance the composition the ‘358 patent for the downstream use of detecting the biomarkers to determine if the subjects have ovarian cancer in view of Chan and Lokshin and to facilitate washing and subsequent isolation of the complex prior to contacting the antibody with a sample as taught by Chan.
Regarding claim 1 (b) and (f), It would have been obvious to a person of ordinary skill in the art before the invention was filed to add the HE4, FSH, and transferrin or transthyretin and FSH and further comprising interleukin-8, leptin, MIP-1α, and TNFα antibodies of Lokshin and Chan to the reagent set and article of manufacture of the ‘358 patent in view of Chan. A person of ordinary skill in the art would have had a reasonable expectation of success to do so because Chan, Lokshin, and the ‘358 patent are directed towards reagents capable of detecting biomarkers. The skilled artisan would have been motivated to do so because the addition would predictably enhance the composition the ‘358 patent for the downstream use of detecting the biomarkers to determine if the subjects have ovarian cancer in view of Chan and Lokshin.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
Response to Arguments
Applicant’s arguments on pages 6-8 of the reply have been fully considered but they are not persuasive for the reasons set forth below.
On pages 6-7 of reply, Applicant alleges that none of the applied references under 35 U.S.C. § 103 teach the elected combination of markers of claim 1(b) and particularly transferrin. This is not found persuasive of error because Chan is not applied alone, but in combination with Lokshin and the 2nd pre-grant publication to Chan, and the claimed invention becomes obvious when the references are considered together as a whole rather than each alone.
Applicant’s remarks regarding the nonstatutory double patenting rejections of record on page 7 of the reply are acknowledged, but not found persuasive of error as no specific arguments were made. The guidance given in M.P.E.P. § 804 subsection I (A) is clear that double patenting rejections should continue to be made by the examiner in the instant application as long as there are conflicting claims with issued patent(s). Applicant may overcome the nonstatutory double patenting rejection in one of three ways: 1) Amending the claims in question so the claimed invention in the instant application and the conflicting patent(s) are no long obvious variants of each other as set forth above, 2) file a terminal disclaimer, or 3) persuasively argue why the instantly claimed invention is not obvious over the issued patent.
Conclusion
No claims are allowed. No claims are free of the art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN C BARRON whose telephone number is (571)270-5111. The examiner can normally be reached 7:30am-3:30pm EDT/EST (M-F).
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/Sean C. Barron/Primary Examiner, Art Unit 1653