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 1-18 have an effective filing date of 04 JAN 2006.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 4/8/2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Status of Claims
Claims 1-18 are currently pending and presented for examination on the merits.
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 1-11 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(s) assessing whether a patient is afflicted with an endometrial or uterine cance. This judicial exception is not integrated into a practical application because 'natural phenomenon' include: . 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. Furthermore, it would have been obvious to one of skill in the art, at the time of filing, to monitor a known antigen associated with a cancer and for an increase of HE4 in a sample, at the later time, indicates that the patient has endometrial cancer.
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).
Claims 12-14 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(s) assessing the response of a patient afflicted with an endometrial or uterine cancer to a treatment, the method comprising assessing expression of HE4 in samples obtained from the patient at different times during treatment, wherein decreased expression of HE4 at the later time indicates that the patient is responding to the treatment. This judicial exception is not integrated into a practical application because 'natural phenomenon' include: levels of natural occurring protein HE4 correlate with 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. 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 for a decreased of HE4 in a sample, at the later time, indicates that the patient is responding to the treatment.
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 15-18 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(s) assessing recurrence in a patient who has been treated for an endometrial or uterine cancer, the method comprising assessing expression of HE4 in samples obtained from the patient following treatment, wherein elevated expression of HE4 indicates that the endometrial or uterine cancer is recurring in the patient. This judicial exception is not integrated into a practical application because 'natural phenomenon' include: levels of natural occurring protein HE4 correlate with presence of reoccurring endometrial 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).
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, 7-10, 12-13 15-16 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), and further in view of 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).
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 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].
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, 10, 12, and 13, 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, is the only active step of claims 10, 12, and 13.
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.
One of ordinary skill in the art, before the effective filing date, would have been motivated to use 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. 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 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, because Schummer teaches elevated HE4 in sample shows cancer cells and Drapkin teaches elevated HE4 in endometrial samples.
Claim 6 is 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) as applied to claims 1-5, 7-10, 12-13 15-16 and 18 are above, and further in view of Buhimschi et al (WO2004072638 A1).
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.
Claims 11, 14, and 17 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) as applied to claims 1-5, 7-10, 12-13 15-16 and 18 are above, and further in view of Hassan et al (Mesothelin: A New Target for Immunotherapy, Clinical Canc. Res., Vol. 10, pgs. 3937-3942, June 2004).
The teachings of Schummer et al and Drapkin et al are discussed above.
Schummer et al does not specifically teach expression of SMRP. However, this deficiency is made up in the teachings of Hassan et al.
In regards to claim 11, 14, and 17, 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, 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 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, and Hassan’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 and elevated expression of CA125 and SMRP, because Schummer teaches elevated HE4 in sample shows cancer cells, Drapkin teaches elevated HE4 in endometrial samples, and Hassan teaches elevated expression of CA125 and SMRP in many cancers.
Conclusion
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/DENNIS J SULLIVAN/ Examiner, Art Unit 1642
/NELSON B MOSELEY II/ Primary Examiner, Art Unit 1642