Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Claims 1-9, 12, 15, and 18 have an effective filing date of 04JAN2006.
Status of Claims
Claims 1-9, 12, 15, and 18 are currently pending and presented for examination on the merits.
Claims 1, 12, and 15 are amended.
Claims 10-11, 13-14, and 16-17 are canceled.
Rejections Withdrawn
The rejection filed under 35 U.S.C. 103 is withdrawn in view of Applicant’s Amendments to claims.
Rejections Maintained
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-9 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more. The claim(s) recite a natural phenomenon, specifically, the relationship between the expression of HE4, CA125, and SMRP and a diagnosis of endometrial or uterine cancer. This judicial exception is not integrated into a practical application because 'natural phenomenon' include: levels of natural occurring protein HE4 correlate with presence of endometrial cancer. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements (common methods of detecting expression) are routinely performed in the art to obtain data regarding expression and treat subjects.
A claim that focuses on judicial exception(s) can be shown to recite something “significantly more” than the judicial exception(s) by reciting a meaningful limitation beyond the judicial exceptions. However, in the instant case, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements (when considered both individually and as an ordered combination) are limited to well-understood, routine and conventional limitations of determining the level of a protein in a biological sample from a subject (“Step 2B”). Well-understood, routine and conventional limitations are not meaningful limitations and are not enough to qualify the claimed method as reciting something “significantly more” than the judicial exception(s) (see Part I.B.1 of the interim Guidance).
MPEP 2106.05(d)(II) provides a non-limiting list of laboratory techniques recognized by courts as well-understood, routine, conventional activity. These techniques include:
i. Determining the level of a biomarker in blood by any means, Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1362, 123 USPQ2d 1081, 1088 (Fed. Cir. 2017);
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Further, the active method steps are conventional and routine in the art for the reasons stated above and the claims do not amount to significantly more than the judicial exception(s). The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements (common methods of detecting expression) are routinely performed in the art to obtain data regarding expression and treat subjects. The claims do not recite something “significantly more” than the judicial exception(s); rather, the claims “simply inform” the natural phenomenon to one performing routine active method steps and do not amount to significantly more than the judicial exception(s).
Claim 12 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more. The claim(s) recite a natural phenomenon, specifically, the relationship between the expression of HE4, CA125, and SMRP and a response to treatment. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements (common methods of detecting expression) are routinely performed in the art to obtain data regarding expression and treat subjects.
A claim that focuses on judicial exception(s) can be shown to recite something “significantly more” than the judicial exception(s) by reciting a meaningful limitation beyond the judicial exceptions. However, in the instant case, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements (when considered both individually and as an ordered combination) are limited to well-understood, routine and conventional limitations of determining the level of a protein in a biological sample from a subject (“Step 2B”). Well-understood, routine and conventional limitations are not meaningful limitations and are not enough to qualify the claimed method as reciting something “significantly more” than the judicial exception(s) (see Part I.B.1 of the interim Guidance).
MPEP 2106.05(d)(II) provides a non-limiting list of laboratory techniques recognized by courts as well-understood, routine, conventional activity. These techniques include:
i. Determining the level of a biomarker in blood by any means, Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1362, 123 USPQ2d 1081, 1088 (Fed. Cir. 2017);
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The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements (common methods of detecting expression) are routinely performed in the art to obtain data regarding expression and treat subjects. The claims do not recite something “significantly more” than the judicial exception(s); rather, the claims “simply inform” the natural phenomenon to one performing routine active method steps and do not amount to significantly more than the judicial exception(s).
Claims 15 and 18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more. The claim(s) recite a natural phenomenon, specifically, the relationship between the expression of HE4, CA125, and SMRP and the recurrence of endometrial or uterine cancer. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because 'natural phenomenon' include: levels of natural occurring protein HE4 correlate with presence of endometrial cancer. Further, it would have been obvious to one skill in the art, at the time of filing, to monitor a known antigen associated with a cancer and an increase in HE4 in a sample, at the later time, indicates that the patient has cancer than is reoccurring.
A claim that focuses on judicial exception(s) can be shown to recite something “significantly more” than the judicial exception(s) by reciting a meaningful limitation beyond the judicial exceptions. However, in the instant case, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements (when considered both individually and as an ordered combination) are limited to well-understood, routine and conventional limitations of determining the level of a protein in a biological sample from a subject (“Step 2B”). Well-understood, routine and conventional limitations are not meaningful limitations and are not enough to qualify the claimed method as reciting something “significantly more” than the judicial exception(s) (see Part I.B.1 of the interim Guidance).
MPEP 2106.05(d)(II) provides a non-limiting list of laboratory techniques recognized by courts as well-understood, routine, conventional activity. These techniques include:
i. Determining the level of a biomarker in blood by any means, Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1362, 123 USPQ2d 1081, 1088 (Fed. Cir. 2017);
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Further, the active method steps are conventional and routine in the art for the reasons stated above and the claims do not amount to significantly more than the judicial exception(s). The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements (common methods of detecting expression) are routinely performed in the art to obtain data regarding expression and treat subjects. Moreover, “[w]hile preemption may signal patent ineligible subject matter, the absence of complete preemption does not demonstrate patent eligibility…” Ariosa Diagnostic, Inc., v. Sequenom, Inc., 788 F.3d 1371, 1379 (Fed. Cir. 2015), cert. denied, No.15-1182, 2016 WL 1117246 (U.S. June, 2016). Further, “Groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the §101 inquiry.” Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107, 2117 (2013). The claims do not recite something “significantly more” than the judicial exception(s); rather, the claims “simply inform” the natural phenomenon to one performing routine active method steps and do not amount to significantly more than the judicial exception(s).
Applicant Arguments:
This application of specific assays to detect the complex formed by this particular peptide-antibody preparation represents a practical application significantly distinct from merely observing the presence of HE4. Therefore, the claimed method integrates any potential judicial exception into a specific diagnostic application involving significantly more than routine or conventional activity.
Examiner’s Response:
MPEP 2106.04(b)
The courts have identified the following concepts and products as examples of laws of nature or natural phenomena:
v. a correlation between the presence of myeloperoxidase in a bodily sample (such as blood or plasma) and cardiovascular disease risk, Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1361, 123 USPQ2d 1081, 1087 (Fed. Cir. 2017);X
Even if a claim does recite a law of nature or natural phenomenon, it may still be eligible at any of Pathways A through C. For example, claims reciting a naturally occurring relationship between a patient’s genotype and the risk of QTc prolongation (a law of nature) were held eligible as not "directed to" that relationship because they also recited a step of treating the patient with an amount of a particular medication that was tailored to the patient’s genotype. Vanda Pharms., 887 F.3d at 1134-36, 126 USPQ2d at 1279-81. This particular treatment step applied the natural relationship in a manner that integrated it into a practical application. The court’s analysis in Vanda is equivalent to a finding of eligibility at Step 2A Prong Two (Pathway B).
It is further noted that the claims do not recite additional elements that
integrate the judicial exception into a practical application. In addition to the recited judicial exception, the claims recite known and routine laboratory assays. As such these steps do not integrate the judicial exception into a practical application. The claims also do not recite any sort of treatment methods that would integrate the recited judicial exception, for example, by applying or using said judicial exception to provide a particular treatment or prophylaxis for a disease or medical condition.
New Rejections
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-9, 12, 15, and 18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1, 12, and 15, lines 13-15, recite “the method comprises the use of an enzyme linked immunosorbent assay (ELISA), radioimmunoassay (RIA), immunofluorimetry, immunoprecipitation, equilibrium dialysis, immunodiffusion.” It is unclear if this is a list to choose from or if all types must be utilized.
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.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1-5, 7-9, 12, 15, and 18 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Schummer et al (US 20030108965, IDS 04/08/2024), Drapkin et al (Human Epididymis Protein (HE4) is a secreted glycoprotein that is overexpressed by serious and endometrioid Ovarian Carcinomas, 2005, 65:(6), pgs. 2162-2169, IDS 04/08/2024), Schummer '273 (WO 03/021273 A2, IDS 4/8/2024), and further in view of Hassan et al (Mesothelin: A New Target for Immunotherapy, Clinical Canc. Res., Vol. 10, pgs. 3937-3942, June 2004, Previous OA).
With regard to claim 1, Schummer et al teaches a method of screening for the presence of a malignant condition in a subject [0044]. Schummer et al further teaches subjects with elevated levels of HE4a polypeptides in subjects having certain carcinomas [0117]. Specifications of the instant application state “detection of either HE4 or HE4a are considered synonymous, and detection of either molecule can be used in the methods described herein” [0034]. Schummer et al further teaches the sample from the subject being serum [0014]. Schummer et al further teaches the subject being patients [0145]. Schummer et al further teaches the presence of elevated HE4a in a biological sample can be used to show the presence of cancer cells [0099]. Schummer et al further teaches using ELISA to detect HE4 antibodies [0040]. Schummer et al further teaches the detection of CA125 as a marker of a malignant condition [0025]. Furthermore one of ordinary skill in the art would appreciate that the expression of tumor markers can be measured at various time points to determine whether an individual has developed cancer, which would be associated with an increase in the expression said tumor markers. It is also noted that measuring the expression of a tumor marker, either HE4 or CA125.
Schummer et al does not specifically teach the cancer being endometrial cancer and samples from solid tissue types. However, this deficiency is made up in the teachings of Drapkin et al.
With regard to claim 1, Drapkin et al teaches the detection of HE4 on endometrial carcinoma [Right column, pg. 2165].
Schummer et al does not specifically teach the HE4 antibody 2H5. However, this deficiency is made up in the teachings of Schummer et al (Schummer ‘273).
With regards to claim 1, Schummer ‘273 teaches HE4 antibodies 2H5, 3D8, and 4H4 to detect HE4 antigen [Lines 11-12, pg. 8].
Schummer et al does not specifically teach expression of SMRP. However, this deficiency is made up in the teachings of Hassan et al.
Hassan et al teaches the antigen mesothelin [Abstract]. Hassan et al further teaches testing for soluble mesothelin-related proteins (SMRP) [Left column, 3rd Paragraph, pg. 3939]. Hassan et al further teaches SMRP is present in normal cells and highly expressed in cancers, including pancreatic, ovarian, mesotheliomas, and many other cancers [Introduction, 1st Paragraph, pg. 3937]. Hassan et al teaches that SMRP by itself lacks sensitivity and specificity as a tumor marker in cancer, but may complement CA125 for the detection of cancer [Right column, 2nd Paragraph, pg. 3941]. Hassan et al further teaches SMRP binds CA125 and this interaction mediates cell adhesion [Right column, 1st Paragraph, pg. 3939].
One of ordinary skill in the art, before the effective filing date, would have been motivated to combine Schummer’s method to detect the presence of cancer cells by measuring for elevated HE4 and assessing the subject has cancer, with Drapkin et al to assess if a subject has endometrial cancer and elevated HE4, with Schummer ‘273 method of detecting HE4 using antibodies 2H5, 3D8, and 4H4, with Hassan’s method of detecting CA125 and SMPR in cancer samples. The idea of combining them flows logically from their having been individually taught in the prior art (MPEP 2144.06). Combining prior art elements according to known methods to yield predictable results is an exemplary rationale for a prima facie case of obviousness. MPEP2143. It would have been prima facie obvious to combine Schummer, Drapkin, Schummer ‘273, and Drapkin’s method for a method of assessing whether a person is afflicted with an endometrial or uterine by elevated expression of HE4 in a sample obtained from a patient, assessing the expression of HE4 using antibodies 2H5, 3D8, and 4H4, assessing the expression of two additional markers CA125 and SMRP from the sample, wherein elevated expression of CA125 or SMRP indicates the patient is afflicted with endometrial or uterine cancer, wherein the method comprises the use of ELISA, RIA, immunofluorimetry, immunoprecipitation, equilibrium dialysis, or immunodiffusion, because Schummer teaches elevated HE4 in sample shows cancer cells, Drapkin teaches elevated HE4 in endometrial samples, Schumer ‘273 teach antibodies 2H5, 3D8, and 4H4 to detect HE4, and Hassan teaches elevated SMRP and CA125 expression in cancers.
With regard to claim 2, Drapkin et al further teaches the detection of HE4 from formalin-fixed brain, esophagus, stomach, endometrium, and other tissue types [Left column, pg. 2164].
With regard to claims 3 and 4, Schummer et al further teaches the biological fluid can be serum [0014].
With regard to claim 5, Schummer et al further teaches the biological fluid may include liquid solutions contacted with a subject or biological source [0096].
With regard to claims 7 and 8, Schummer et al further teaches comparing the expression of HE4 levels in biological sample to expression in normal tissue [0147].
With regard to claims 9 and 12, Schummer et al further teaches the detection of CA125 as a marker of a malignant condition [0025]. Furthermore one of ordinary skill in the art would appreciate that the expression of tumor markers can be measured at various time points to determine whether an individual has developed cancer, which would be associated with an increase in the expression said tumor markers.
With regard to claim 15, Schummer et al further teaches subjects with elevated levels of HE4a polypeptides in subjects having certain carcinomas [0117]. Specifications of the instant application state “detection of either HE4 or HE4a are considered synonymous, and detection of either molecule can be used in the methods described herein” [0034]. Schummer et al further teaches the sample from the subject being serum [0014]. Schummer et al further teaches the subject being patients [0145]. Schummer et al further teaches the presence of elevated HE4a in a biological sample can be used to show the presence of cancer cells [0099]. With regard to claim 16, Schummer et al further teaches the detection of CA125 as a marker of a malignant condition [0025]. Furthermore with respect to claim 18, one of ordinary skill in the art would appreciate that measuring the expression of tumor markers may be used to diagnose cancer or determine whether a particular cancer treatment is effective, i.e., by comparing the expression of tumor antigens over time.
Claims 1-9, 12, 15, and 18 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Schummer et al (US 20030108965, IDS 04/08/2024), Drapkin et al (Human Epididymis Protein (HE4) is a secreted glycoprotein that is overexpressed by serious and endometrioid Ovarian Carcinomas, 2005, 65:(6), pgs. 2162-2169, IDS 04/08/2024), Schummer '273 (WO 03/021273 A2, IDS 4/8/2024), Hassan et al (Mesothelin: A New Target for Immunotherapy, Clinical Canc. Res., Vol. 10, pgs. 3937-3942, June 2004, Previous OA) as applied to claims 1-5, 7-9, 12, 15, and 18 are above, and further in view of Buhimschi et al (WO2004072638 A1, Previous OA).
The teachings of Schummer et al and Drapkin et al are discussed above.
Schummer et al does not specifically teach the sample is a wash fluid. However, this deficiency is made up in the teachings of Buhimschi et al.
In regards to claim 6, Buhimschi et al teaches detecting biomarkers to indicate various conditions [0024]. Buhimschi et al further teaches a kit for detecting biomarkers from a sample [0032]. Buhimschi et al further teaches the sample is a vaginal sample [0024]. Buhimschi et al further teaches the vaginal sample is a vaginal fluid [0032]. Buhimschi et al further teaches the kit includes a washing solution for removing unbound material [0032].
One of ordinary skill, before the effective filing date, would have been motivated to combine the method of Schummer et al to detect the presence of cancer cells by measuring for elevated HE4 and assessing the subject has cancer, with Drapkin et al to assess if a subject has endometrial cancer and to sample solid tissue, with Buhimschi’s method of detecting antigens by vaginal douche fluid. The idea of combining them flows logically from their having been individually taught in the prior art (MPEP 2144.06). Combining prior art elements according to known methods to yield predictable results is an exemplary rationale for a prima facie case of obviousness. MPEP2143. It would have been prima facie obvious to combine Schummer, Drapkin, and Buhimschi’s method for a method of assessing whether a person is afflicted with an endometrial or uterine by elevated expression of HE4 in a sample obtained from a patient, wherein the sample is a vaginal douche fluid, because Schummer teaches elevated HE4 in sample shows cancer cells, Drapkin teaches elevated HE4 in endometrial samples, and Buhimschi teaches detecting antigens in vaginal washes.
Applicant’s Arguments:
Neither Schumer nor Drapkin, either individually or in combination, disclose or suggest the detection of HE4, CA125 and SMRP for purposes of assessing the presence of endometrial cancer, assessing the response of a patient afflicted with an endometrial or uterine cancer to a treatment, or assessing recurrence in a patient who has been treated for an endometrial or uterine cancer as claimed herein.
Buhimschi fails to remedy the deficiencies of Schummer and/or Drapkin. Neither Schumer, Drapkin, nor Buhimschi either individually or in combination, disclose or suggest the detection of HE4, CA125 and SMRP for purposes of assessing the presence of endometrial cancer, assessing the response of a patient afflicted with an endometrial or uterine cancer to a treatment, or assessing recurrence in a patient who has been treated for an endometrial or uterine cancer as claimed herein.
Contrary to the assertions in the Office Action, Hassan is limited to the discussion of mesothelin and does not include a discussion of CA125 and SMRP. Applicant respectfully submits that CA125 and SMRP are not equivalent to mesothelin. See for example, [0008] which discusses CA125 and mesothelin as separate indicators of cancer.
Applicant further notes that SMRP is also not equivalent to mesothelin: according to Gross et al.
Neither Schumer, Drapkin, nor Hassan either individually or in combination, disclose or suggest the detection of HE4, CA125 and SMRP for purposes of assessing the presence of endometrial cancer, assessing the response of a patient afflicted with an endometrial or uterine cancer to a treatment, or assessing recurrence in a patient who has been treated for an endometrial or uterine cancer as claimed herein.
Examiner’s Response:
Applicant states, “Neither Schumer nor Drapkin, either individually or in combination, disclose or suggest the detection of HE4, CA125 and SMRP for purposes of assessing the presence of endometrial cancer, assessing the response of a patient afflicted with an endometrial or uterine cancer to a treatment, or assessing recurrence in a patient who has been treated for an endometrial or uterine cancer as claimed herein.”
Schummer et al teaches a method of screening for the presence of a malignant condition in a subject [0044]. Schummer et al further teaches subjects with elevated levels of HE4a polypeptides in subjects having certain carcinomas [0117]. Specifications of the instant application state “detection of either HE4 or HE4a are considered synonymous, and detection of either molecule can be used in the methods described herein” [0034]. Schummer et al further teaches the sample from the subject being serum [0014]. Schummer et al further teaches the subject being patients [0145]. Schummer et al further teaches the presence of elevated HE4a in a biological sample can be used to show the presence of cancer cells [0099]. Schummer et al further teaches using ELISA to detect HE4 antibodies [0040]. Schummer et al further teaches the detection of CA125 as a marker of a malignant condition [0025]. Furthermore one of ordinary skill in the art would appreciate that the expression of tumor markers can be measured at various time points to determine whether an individual has developed cancer, which would be associated with an increase in the expression said tumor markers. It is also noted that measuring the expression of a tumor marker, either HE4 or CA125.
Drapkin et al teaches the detection of HE4 on endometrial carcinoma [Right column, pg. 2165].
Hassan et al teaches the antigen mesothelin [Abstract]. Hassan et al further teaches testing for soluble mesothelin-related proteins (SMRP) [Left column, 3rd Paragraph, pg. 3939]. Hassan et al further teaches SMRP is present in normal cells and highly expressed in cancers, including pancreatic, ovarian, mesotheliomas, and many other cancers [Introduction, 1st Paragraph, pg. 3937]. Hassan et al teaches that SMRP by itself lacks sensitivity and specificity as a tumor marker in cancer, but may complement CA125 for the detection of cancer [Right column, 2nd Paragraph, pg. 3941].
One of ordinary skill in the art, before the effective filing date, would have been motivated to combine Schummer’s methods of detecting HE4 and CA125 to detect cancer, with Drapkin’s method of detecting endometrial cancer from elevated expression of HE4, with Hassan’s method of detecting cancer from elevated expression of SMRP. The idea of combining them flows logically from their having been individually taught in the prior art (MPEP 2144.06). Combining prior art elements according to known methods to yield predictable results is an exemplary rationale for a prima facie case of obviousness. MPEP2143. It would have been prima facie obvious to combine Schummer, Drapkin, and Hassan’s methods for a method of assessing if a patient is afflicted with endometrial cancer comprising assessing the expression of HE4, CA125, and SMRP, because Schummer teaches elevated HE4 and CA125 in cancers, Drapkin teaches elevated HE4 in endometrial cancer, and Hassan teaches the detection of elevated SMRP in many cancers.
Applicant states, “Hassan is limited to the discussion of mesothelin and does not include a discussion of CA125 and SMRP “.
Hassan teaches testing for soluble mesothelin-related proteins (SMRP) [Left column, 3rd Paragraph, pg. 3939]. Hassan et al further teaches SMRP is present in normal cells and highly expressed in cancers, including pancreatic, ovarian, mesotheliomas, and many other cancers [Introduction, 1st Paragraph, pg. 3937]. Hassan et al teaches that SMRP by itself lacks sensitivity and specificity as a tumor marker in cancer, but may complement CA125 for the detection of cancer [Right column, 2nd Paragraph, pg. 3941].
One of ordinary skill would recognize that Hassan teaches that soluble mesothelin-related proteins (SMRPs) are valuable for the diagnosis or follow-up of cancer patients.
Conclusion
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DENNIS JOHN SULLIVAN whose telephone number is (571)272-0509. The examiner can normally be reached Mon - Fri: 7:30AM - 4:30PM.
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/DENNIS J SULLIVAN/ Examiner, Art Unit 1642
/NELSON B MOSELEY II/ Primary Examiner, Art Unit 1642
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