DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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 – 7, 9 – 12 and 18 – 25 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claims 1 – 7, 9, 10, 18 – 20, 24 and 25 recite determination and comparison steps.
This judicial exception is not integrated into a practical application because the determination and comparison steps in independent claims 1 and 7 are merely an evaluation which is a mental process and abstract idea. The dependent claims only further refine the abstract idea. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because nothing in the claims precludes these steps from practically being performed in the mind. These claims are directed to an abstract idea and are therefore not patent eligible.
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.
Claim 20 is 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.
Regarding claim 20, this claim is not clear, and is considered indefinite. It is not clear as to how the score further takes into account the NSCLC subtype by using an interaction term based on the information about the NSCLC subtype and the level of CYFRA 21 and/or the level of CA 125. The definition of the “interaction term” and how it is used and related to the information recited in claim 10 and the recited subtypes and markers.
Claim Rejections - 35 USC § 102
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 following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1 – 7, 9 – 12 and 17 – 25 is/are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by McKeegan et al. (US 2012/0115745 A1; “McKeegan”).
Regarding claim 1, McKeegan teaches throughout the publication an in vitro method for assessing the risk of non-small cell lung carcinoma (NSCLC) disease progression for a subject suffering from non-small cell lung carcinoma (NSCLC) and being under an ongoing NSCLC treatment regime, wherein the subject is classified to have a stable disease (e.g., Example 2; paragraphs 2, 8 – 11, 16 and 72 – 74), and wherein said method comprises:
a) determining a level of CYFRA 21-1 (the disclosed method predicts the sensitivity of a cancer in a subject to administration of ABT-869 via the determination of the level of biomarker CYFRA 21-1; paragraphs 8, 9 and 14) and/or a level of CA 125 (paragraph 16) in a sample obtained from the subject; and
b) comparing (i) the determined level of CYFRA 21-1 to a CYFRA 21-1 cut-off level (e.g., the level of the marker in a test sample is compared to a predetermined level of each marker, wherein the predetermined level indicates sensitivity of the cancer to the administration of ABT-869 to the subject; paragraphs 8, 9 and 14), (ii) the determined level of CA 125 to a CA 125 cut-off level, or (iii) a score taking into account the determined level of CYFRA 21-1 and/or the determined level of CA 125 to a cut-off score (e.g., a marker signature having a predetermined pattern can be used to indicate an increased sensitivity of the subject to administration of ABT-869 to the subject; paragraphs 8. 9 and 14).
Regarding claim 2, McKeegan teaches the method of claim 1, wherein in step (a) the level of CYFRA 21-1 is determined and the comparing in step (b) comprises (i) as defined in claim 1(b), wherein a determined level of CYFRA 21-1 lower than or equal to the CYFRA 21-1 cut-off level is indicative of a low risk of NSCLC disease progression; and/or wherein a determined level of CYFRA 21-1 higher than the CYFRA 21-1 cut-off level is indicative of a high risk of NSCLC disease progression (e.g., the level of the marker in a test sample is compared to a predetermined level of each marker, wherein the predetermined level indicates sensitivity of the cancer to the administration of ABT-869 to the subject; paragraphs 8 and 9;
determined marker values can be compared to threshold marker concentration values and can be predictive for NSCLC vs. benign lung disease and comparison of relative concentration of the marker in patients with stable disease vs. rapid progression on therapy with ABT-869; paragraphs 72 – 74).
Regarding claim 3, McKeegan teaches the method of claim 2, wherein the subject suffers from NSCLC of subtype adenocarcinoma (ADC-NSCLC) (Table 1; paragraph 4).
Regarding claim 4, McKeegan teaches the method of claim 1, wherein in step (a) the level of CA 125 is determined and the comparing in step (b) comprises (ii) as defined in claim 1(b), wherein a determined level of CA 125 lower than the CA 125 cut-off level is indicative of a low risk of NSCLC disease progression (Determined marker values can be compared to threshold marker concentration values and can be predictive for NSCLC vs. benign lung disease and comparison of relative concentration of the marker in patients with stable disease vs. rapid progression on therapy with ABT-869; paragraphs 8 and 72 – 75); and/or
wherein a determined level of CA 125 higher than the CA 125 cut-off level is indicative of a high risk of NSCLC disease progression (Determined marker values can be compared to threshold marker concentration values and can be predictive for NSCLC vs. benign lung disease and comparison of relative concentration of the marker in patients with stable disease vs. rapid progression on therapy with ABT-869; paragraphs 8 and 72 – 75).
Regarding claim 5, McKeegan teaches the method of claim 4, wherein the subject suffers from NSCLC of subtype squamous cell carcinoma (SCC-NSCLC) (Table 1; paragraph 4).
Regarding claim 6, McKeegan teaches the method of claim 1, wherein in step (a) the levels of CYFRA 21-1 and/or CA 125 are determined and the comparing in step (b) comprises (iii) as defined in claim 1(b), and wherein a determined score lower than the cut-off score is indicative of a low risk of NSCLC disease progression (Determined marker values can be compared to threshold marker concentration values and can be predictive for NSCLC vs. benign lung disease and comparison of relative concentration of the marker in patients with stable disease vs. rapid progression on therapy with ABT-869; paragraphs 8 and 72 – 75); and/or wherein a determined score higher than the cut-off score is indicative of a high risk of NSCLC disease progression (Determined marker values can be compared to threshold marker concentration values and can be predictive for NSCLC vs. benign lung disease and comparison of relative concentration of the marker in patients with stable disease vs. rapid progression on therapy with ABT-869; paragraphs 8 and 72 – 75).
Regarding claim 7, McKeegan teaches throughout the publication an in vitro method for assessing whether for a subject diagnosed with non-small cell lung carcinoma (NSCLC) an ongoing NSCLC treatment regime is to be maintained or modified and/or whether a subject diagnosed with non-small cell lung carcinoma (NSCLC) responds to an ongoing NSCLC treatment regime, wherein said subject is classified to have a stable disease, and wherein said method comprises:
determining a level of CYFRA 21-1 (the disclosed method predicts the sensitivity of a cancer in a subject to administration of ABT-869 via the determination of the level of biomarker CYFRA 21-1; paragraphs 8, 9 and 14) and/or a level of CA 125 (paragraph 16) in a sample obtained from the subject; and
comparing (i) the determined level of CYFRA 21-1 to a CYFRA 21-1 cut-off level, (ii) the determined level of CA 125 to a CA 125 cut-off level, or (iii) a score taking into account the determined level of CYFRA 21-1 and/or the determined level of CA 125 to a cut-off score (e.g., the level of the marker in a test sample is compared to a predetermined level of each marker, wherein the predetermined level indicates sensitivity of the cancer to the administration of ABT-869 to the subject; paragraphs 8 and 9).
Regarding claim 9, McKeegan teaches the method of claim 1, wherein the method further comprises determining a level of CEA (Example 2; paragraph 4, 8 – 12 and 16), and wherein the comparing in step (b) comprises or consists of (iii) as defined in claim 1(b), 7b) or 8b), respectively, and wherein the score further takes into account the determined level of CEA.
Regarding claim 10, McKeegan teaches the method of claim 1, wherein the method further comprises:
obtaining an information whether the subject suffers from non-small cell lung carcinoma subtype squamous cell carcinoma (SCC-NSCLC) or adenocarcinoma (ADCNSCLC) (paragraph 2; Table 1);
wherein the comparing in step (b) comprises (iii) as defined in claim 1(b), and wherein the score further takes into account the NSCLC subtype (Example 2; paragraph 4, 8 – 12 and 16).
Regarding claim 11, McKeegan teaches the method of claim 1, wherein the sample is a sample obtained 10 days to 150 days after the start date of the ongoing treatment regime (paragraph 41).
Regarding claim 12, McKeegan teaches the method of claim 1, wherein the sample is a blood sample (paragraphs 38 and 41).
Regarding claim 17, McKeegan teaches a kit (Examples 1 and 2; paragraphs 8, 11, 50, 61, 67 and 68) comprising:
a reagent or a set of reagents for detecting a level of CYFRA 21-1 (e.g., a binding reagent; paragraph 11); and/or
a reagent or a set of reagents (e.g., a binding reagent; paragraph 11) for detecting a level of CA 125, and optionally a reagent or set of reagents for detecting a level of CEA in a sample obtained from a subject, wherein the kit is a kit capable of assessing:
the risk of NSCLC disease progression under an ongoing NSCLC treatment regime for a subject diagnosed with NSCLC;
whether a subject diagnosed with NSCLC responds to an ongoing NSCLC treatment regime; and/or
whether for a subject diagnosed with NSCLC an ongoing NSCLC treatment regime is to be maintained or modified;
wherein said subject of (i), (ii), and (iii) is classified to have a stable disease.
Regarding claim 18, McKeegan teaches the method of claim 7, wherein the method further comprises determining a level of CEA (e.g., paragraphs 7, 8 and 11), and wherein the comparing in step (b) comprises (iii) as defined in claim 7(b), and wherein the score further takes into account the determined level of CEA.
Regarding claim 19, McKeegan teaches the method of claim 7, wherein the method further comprises:
obtaining an information whether the subject suffers from non-small cell lung carcinoma subtype squamous cell carcinoma (SCC-NSCLC) or adenocarcinoma (ADC-NSCLC) (paragraph 2; Table 1);
wherein the comparing in step (b) comprises (iii) as defined in claim 7(b), and wherein the score further takes into account the NSCLC subtype (paragraphs 4 and 14 and 15; Table 1).
Regarding claim 20, McKeegan teaches the method of claim 10, wherein the score further takes into account the NSCLC subtype (paragraphs 4 and 14 and 15; Table 1) by using an interaction term between the information about the NSCLC subtype and the level of CYFRA 21 and/or the level of CA 125 (paragraph 4; Table 1).
Regarding claim 21, McKeegan teaches the method of claim 11, wherein the sample is a sample obtained 20 days to 120 days after the start date of the ongoing treatment regime (paragraph 41).
Regarding claim 22, McKeegan teaches the method of claim 11, wherein the sample is a sample obtained 25 days to 108 days after the start date of the ongoing treatment regime (paragraph 41).
Regarding claim 23, McKeegan teaches the method of claim 12, wherein the sample is a blood sample selected from the group consisting of whole blood, serum, and plasma (paragraphs 10, 12, 38 and 41).
Regarding claim 24, McKeegan teaches the method of claim 1, wherein said subject is a subject classified to have a stable disease based on imaging data (paragraph 46).
Regarding claim 25, McKeegan teaches the method of claim 1, wherein the ongoing NSCLC treatment regime is selected from chemotherapy, targeted therapy, and immunotherapy, and combinations thereof (paragraph 2).
Conclusion
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BRIAN J. SINES
Primary Patent Examiner
Art Unit 1796
/BRIAN J. SINES/Primary Examiner, Art Unit 1796