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 .
Response to Arguments
Applicant's amendments and arguments, filed 5/28/2026, regarding the rejection of claims 1 – 7, 9 – 12 and 17 – 25 under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by McKeegan et al. (US 2012/0115745 A1; hereinafter “McKeegan”), have been fully considered but they are not persuasive. Applicant alleges that independent claims 1 and 7 are not anticipated by McKeegan. Examiner respectfully disagrees. In particular, claims 1 and 7 require that the subject is under an ongoing NSCLC treatment regime and is classified as having a stable disease. McKeegan does disclose in paragraph 36 that “the terms “subject” and “patient” are used interchangeably irrespective of whether the subject has or is currently undergoing any form a treatment.” (emphasis added). So the McKeegan disclosure suggests that their method could be applied to patients being treated in an ongoing treatment regime. Additionally, this term usage suggests that biomarkers could be measured after the start date of the ongoing treatment regime. Furthermore, McKeegan in paragraph 73 does teach that the patient can be classified to have a “stable disease.” The claims do not exclude the McKeegan disclosure regarding this claim term meaning. Applicant is advised that the claims must be given their broadest and reasonable interpretation (see MPEP § 2111). Applicant is also advised that it is improper to import limitations from the specification during examination (see MPEP § 2111.01, part II). The meaning of the claim terms are given their customary meaning as would be understood by a person of ordinary skill in the art as indicated by Applicant’s specification and as supported by the cited pertinent prior art (emphasis added)(see MPEP § 2111.01, part III). Although the methods taught by the prior art may not be what Applicant intends, the language of claims 1 and 7 simply still does not exclude the methodology taught, suggested or implied by the cited prior art. The express, implicit, and inherent disclosures of a prior art reference may be relied upon in the rejection of claims under 35 U.S.C. 102 or 103. “The inherent teaching of a prior art reference, a question of fact, arises both in the context of anticipation and obvious-ness.” In re Napier, 55 F.3d 610, 613, 34 USPQ2d 1782, 1784 (Fed. Cir. 1995) (affirmed a 35 U.S.C. 103 rejection based in part on inherent disclosure in one of the references). See also In re Grasselli, 713 F.2d 731, 739, 218 USPQ 769, 775 (Fed. Cir. 1983) (see MPEP § 2112). “A claim is anticipated only if each and every ele-ment as set forth in the claim is found, either expressly or inherently described, in a single prior art reference.” Verdegaal Bros. v. Union Oil Co. of Cali-fornia, 814 F.2d 628, 631, 2 USPQ2d 1051, 1053 (Fed. Cir. 1987) (see MPEP § 2131). Therefore, this rejection is maintained.
The previous rejection of claims 1 – 7, 9 – 12 and 18 – 25 under 35 U.S.C. 101, has been withdrawn.
The previous rejection of claim 20 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, has been withdrawn.
Note Regarding Prior Art
Examiner cites particular sections, columns, line numbers, paragraphs and figures, in the references as applied to the claims below for the convenience of the Applicant. Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the Applicant fully consider the references in their entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the Examiner.
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 – 28 is/are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by McKeegan et al. (US 2012/0115745 A1; hereinafter “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 (e.g., Example 2; paragraphs 2, 6, 8 – 11, 16 and 72 – 74), wherein the subject is classified to have a stable disease (marker concentration levels in patients were determined, and each patient was classified. It is implicit that a subject could be classified as having a stable disease depending upon their classification; paragraphs 74 and 75) , and wherein said method comprises:
a) determining a level of CYFRA 21-1 by contacting a sample obtained from the subject with least one antibody that specifically binds CYFRA 21-1 and/or determining a level of CA 125 by contacting the sample with at least one antibody that specifically binds CA 125 (e.g., the markers CYFRA 21-1 and CA 125 correlate with tumor histology; paragraph 4; these markers can be correlated and are indicative of non small cell lung cancer (NSCLC); paragraphs 8,9, 45, 50 and 51; the disclosed method also 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), wherein the sample is blood, a serum or a plasma sample (paragraphs 6 and 12; claims 37 – 39) 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); and
c) assessing the risk of NSCLC disease progression for the subject (e.g., the markers CYFRA 21-1 and CA 125 correlate with tumor histology; paragraph 4; these markers can be correlated and are indicative of non small cell lung cancer (NSCLC); paragraphs 8 and 9).
Although, the method disclosed by McKeegan specifically provides a method for predicting the sensitivity of a cancer to administration of ABT-869 to the subject (paragraph 8), McKeegan clearly also teaches that there are markers that are correlated and indicative of the present state or progression of NSCLC in a subject (e.g., paragraphs 4, 8 and 9), which can implicitly be used to assess the risk of NSCLC disease progression for the subject.
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:
a) determining a level of CYFRA 21-1 by contacting a sample obtained from the subject with least one antibody that specifically binds CYFRA 21-1 and/or determining a level of CA 125 by contacting the sample with at least one antibody that specifically binds CA 125 (e.g., the markers CYFRA 21-1 and CA 125 correlate with tumor histology; paragraph 4; these markers can be correlated and are indicative of non small cell lung cancer (NSCLC); paragraphs 8,9, 45, 50 and 51; the disclosed method also 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), wherein the sample is blood, a serum or a plasma sample (paragraphs 6 and 12; claims 37 – 39) 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, (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).
c) assessing whether the ongoing NSCLC treatment regime is to be maintained or modified for the subject (e.g., the markers CYFRA 21-1 and CA 125 correlate with tumor histology; paragraph 4; these markers can be correlated and are indicative of non small cell lung cancer (NSCLC); paragraphs 8 and 9).
Although, the method disclosed by McKeegan specifically provides a method for predicting the sensitivity of a cancer to administration of ABT-869 to the subject (paragraph 8), McKeegan clearly also teaches that there are markers that are correlated and indicative of the present state or progression of NSCLC in a subject (e.g., paragraphs 4, 8 and 9), which can implicitly be used to assess whether the ongoing NSCLC treatment regime is to be maintained or modified for the subject. The sensitivity of a cancer in a subject to the administration of ABT-869 can be assessed and the treatment regime modified (e.g., paragraphs 45 – 49).
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), wherein the interaction term accounts for an association between the NSCLC subtype and the level of CYFRA 21-1 and/or the level of CA 125 in a weighted calculation of the score (e.g., McKeegan teaches the use of a classification or score comparison for each marker and treatment; paragraphs 72 – 75).
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).
Regarding claim 26, McKeegan teaches a method of detecting a level of CYFRA 21-1 and/or CA 125 in a sample from a subject (e.g., paragraphs 4 and 8 – 11 and 72 – 75; Table 1), the method comprising:
providing a sample from the subject, wherein the subject is suffering from non-small cell lung carcinoma (NSCLC), is under an ongoing NSCLC treatment regime, and is classified to have a stable disease (marker concentration levels in patients were determined, and each patient was classified. It is implicit that a subject could be classified as having a stable disease depending upon their classification; paragraphs 74 and 75), and wherein the sample is a blood, a serum, or a plasma sample (paragraphs 6 and 12; claims 37 – 39); and
detecting the level of CYFRA 21-1 by contacting the sample with at least one antibody, or antigen-binding fragment thereof, that specifically binds CYFRA 21-1 and/or detecting the level of CA 125 by contacting the sample with at least one antibody, or antigen-binding fragment thereof, that specifically binds CA 125 (e.g., levels of one or more markers are determined using antibodies in a sample from a subject; paragraphs 4, 8, 9, 50 and 51; Table 1).
Regarding claim 27, McKeegan teaches a method of measuring levels of CYFRA 21-1 and/or CA 125 in a sample from a subject (NSCLC) (e.g., paragraphs 4 and 8 – 11 and 72 – 75; Table 1), the method comprising:
providing a sample from the subject, wherein the subject is suffering from non-small cell lung carcinoma (NSCLC), is under an ongoing NSCLC treatment regime, and is classified to have a stable disease (marker concentration levels in patients were determined, and each patient was classified. It is implicit that a subject could be classified as having a stable disease depending upon their classification; paragraphs 74 and 75), and wherein the sample is a blood, a serum, or a plasma sample (paragraphs 6 and 12; claims 37 – 39); and
measuring the level of CYFRA 21-1 by contacting the sample with at least one antibody, or antigen-binding fragment thereof, that specifically binds CYFRA 21-1 and/or measuring the level of CA 125 by contacting the sample with at least one antibody, or antigen-binding fragment thereof, that specifically binds CA 125 (e.g., levels of one or more markers are determined using antibodies in a sample from a subject; paragraphs 4, 8, 9, 50 and 51; Table 1).
Regarding claim 28, McKeegan teaches a method of measuring a panel of biomarkers in a subject suffering from non-small cell lung carcinoma (NSCLC) (e.g., paragraphs 4 and 8 – 11 and 72 – 75; Table 1), the method comprising:
providing a sample from the subject, wherein the subject is under an ongoing NSCLC treatment regime and is classified to have a stable disease (marker concentration levels in patients were determined, and each patient was classified. It is implicit that a subject could be classified as having a stable disease depending upon their classification; paragraphs 74 and 75), and wherein the sample is a blood, a serum, or a plasma sample (paragraphs 6 and 12; claims 3 – 5); and
determining a measurement for the panel of biomarkers in the sample, wherein the panel comprises CYFRA 21-1, CA 125, and CEA, wherein the measurement comprises determining a level of each of CYFRA 21-1, CA 125, and CEA in the panel (e.g., levels of one or more markers are determined using antibodies in a sample from a subject; paragraphs 4, 8, 9, 50 and 51; Table 1).
Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention 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 35 U.S.C. 103 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 the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 7 and 26 – 28 is/are alternatively rejected under 35 U.S.C. 103 as being unpatentable over McKeegan et al. (US 2012/0115745 A1; hereinafter “McKeegan”).
Regarding claim 1, McKeegan teaches methods for the evaluation and/or treatment of a subject having or suspected of having a neoplastic condition, and in particular to the use of biomarkers for identifying patients receptive to a certain drug therapy and which permits the monitoring of patient response to such therapy (Abstract).
McKeegan does not explicitly teach an in vitro method for assessing the risk of non-small cell lung carcinoma (NSCLC) disease progression or a subject suffering from NSCLC and being under an ongoing NSCLC treatment regime, wherein the subject is classified as having a stable disease. Although, the method disclosed by McKeegan specifically provides a method for predicting the sensitivity of a cancer to administration of ABT-869 to the subject (paragraph 8), McKeegan does teach that there are markers that are correlated and indicative of the present state or progression of NSCLC in a subject (e.g., paragraphs 4, 8 and 9), which can implicitly be used to assess the risk of NSCLC disease progression for the subject.
Regarding claim 1, McKeegan teaches the method steps of:
a) determining a level of CYFRA 21-1 by contacting a sample obtained from the subject with least one antibody that specifically binds CYFRA 21-1 and/or determining a level of CA 125 by contacting the sample with at least one antibody that specifically binds CA 125 (e.g., the markers CYFRA 21-1 and CA 125 correlate with tumor histology; paragraph 4; these markers can be correlated and are indicative of non small cell lung cancer (NSCLC); paragraphs 8,9, 45, 50 and 51; the disclosed method also 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), wherein the sample is blood, a serum or a plasma sample (paragraphs 6 and 12; claims 37 – 39) 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).
McKeegan does teach that the markers CYFRA 21-1 and CA 125 correlate with tumor histology; paragraph 4; these markers can be correlated and are indicative of non small cell lung cancer (NSCLC); paragraphs 8 and 9).
McKeegan does teach that marker concentration levels in patients were determined, and each patient can be classified. It is implicit that a subject could be classified as having a stable disease depending upon their classification (paragraphs 74 and 75). It would have been considered suitable and predictable to a person of ordinary skill in the art utilize steps comprising determining the level of markers CYFRA 21-1 or CA 125 in a subject’s sample, and then compare these levels to a cut-off level or score in order to study the progression of the NSCLC disease for a subject. It would have been obvious to a person of ordinary skill in the art to classify a patient being tested as having a stable disease prior to or at the time of biomarker measurement. It would have been obvious to a person of ordinary skill in the art to provide a method to assess the risk of disease progression and whether treatment should be maintained for a subject already showing stable disease during an ongoing treatment regime so the treatment regime would be safe and effective for the subject. The rationale to support an obviousness rejection under 35 U.S.C. 103 may rely on logic and sound scientific principle (see MPEP § 2144.02). Furthermore, the prior art can be modified or combined to reject claims as prima facie obvious as long as there is a reasonable expectation of success (see MPEP § 2143.02). The combination of familiar elements is likely to be obvious when it does no more than yield predictable results (see MPEP § 2143, A.). Furthermore, the Supreme Court decision in KSR International Co. v. Teleflex Inc., 550 U.S. 82 USPQ2d 1385 (2007) has affirmed that the threshold requirement for a prima facie case of obviousness is “demonstrating that each element was, independently, known in the prior art.” Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to provide a method comprising the steps of determining the level of the CYFRA 21-1 and/or CA 125 in a subject’s sample, and comparing the determined levels of CYFRA 21-1 and CA 125 to cut-off levels or a score or classification, and then assessing the risk of NSCLC disease progression for the subject. Examiner submits that these arguments are in line with the Supreme Court unanimous opinion, KSR International v. Teleflex, Inc., 127 S. Ct. 1727, 1741 (2007), in which the Court stated that “[a] court must ask whether the improvement is more than the predictable use of prior art elements according to their established functions.” Id. at 1731.
Regarding claim 7, the same arguments as applied to claim 1 above apply here to steps a and b. Furthermore, McKeegan does teach that the biomarkers CYFRA 21-1 and CA 125 correlate with tumor histology; paragraph 4; these markers can be correlated and are indicative of non small cell lung cancer (NSCLC); paragraphs 8 and 9). It would have been obvious to a person of ordinary skill in the art to provide a method to assess the risk of disease progression and whether treatment should be maintained or modified for a subject already showing stable disease during an ongoing treatment regime so the treatment regime would be safe and effective for the subject. The rationale to support an obviousness rejection under 35 U.S.C. 103 may rely on logic and sound scientific principle (see MPEP § 2144.02). Furthermore, the prior art can be modified or combined to reject claims as prima facie obvious as long as there is a reasonable expectation of success (see MPEP § 2143.02). The combination of familiar elements is likely to be obvious when it does no more than yield predictable results (see MPEP § 2143, A.). Furthermore, the Supreme Court decision in KSR International Co. v. Teleflex Inc., 550 U.S. 82 USPQ2d 1385 (2007) has affirmed that the threshold requirement for a prima facie case of obviousness is “demonstrating that each element was, independently, known in the prior art.” Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to provide a method comprising the steps of determining the level of the CYFRA 21-1 and/or CA 125 in a subject’s sample, and comparing the determined levels of CYFRA 21-1 and CA 125 to cut-off levels or a score or classification, and then assessing whether the ongoing NSCLC treatment regime is to be maintained or modified so that the treatment regime is safe and effective for the subject.
Regarding claim 26, McKeegan teaches a method of detecting a level of CYFRA 21-1 and/or CA 125 in a sample from a subject (e.g., paragraphs 4 and 8 – 11 and 72 – 75; Table 1), the method comprising:
providing a sample from the subject, wherein the subject is suffering from non-small cell lung carcinoma (NSCLC), and wherein the sample is a blood, a serum, or a plasma sample (paragraphs 6 and 12; claims 37 – 39); and
detecting the level of CYFRA 21-1 by contacting the sample with at least one antibody, or antigen-binding fragment thereof, that specifically binds CYFRA 21-1 and/or detecting the level of CA 125 by contacting the sample with at least one antibody, or antigen-binding fragment thereof, that specifically binds CA 125 (e.g., levels of one or more markers are determined using antibodies in a sample from a subject; paragraphs 4, 8, 9, 50 and 51; Table 1).
McKeegan does not explicitly state that the subject is under an ongoing NSCLC treatment regime and is classified to have a stable disease. It would have been obvious to a person of ordinary skill in the art to classify a patient being tested as having a stable disease prior to or at the time of biomarker measurement. It would have been obvious to a person of ordinary skill in the art to provide a method to assess the risk of disease progression and whether treatment should be maintained for a subject already showing stable disease during an ongoing treatment regime so the treatment regime would be safe and effective for the subject. The rationale to support an obviousness rejection under 35 U.S.C. 103 may rely on logic and sound scientific principle (see MPEP § 2144.02). Furthermore, the prior art can be modified or combined to reject claims as prima facie obvious as long as there is a reasonable expectation of success (see MPEP § 2143.02). The combination of familiar elements is likely to be obvious when it does no more than yield predictable results (see MPEP § 2143, A.). Furthermore, the Supreme Court decision in KSR International Co. v. Teleflex Inc., 550 U.S. 82 USPQ2d 1385 (2007) has affirmed that the threshold requirement for a prima facie case of obviousness is “demonstrating that each element was, independently, known in the prior art.” Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to provide a method comprising the steps of determining the level of the CYFRA 21-1 and/or CA 125 in a subject’s sample, and comparing the determined levels of CYFRA 21-1 and CA 125 to cut-off levels or a score or classification, and then assessing the risk of NSCLC disease progression for the subject that is under an ongoing NSCLC treatment regime and is classified to have a stable disease.
Regarding claim 27, McKeegan teaches a method of measuring levels of CYFRA 21-1 and/or CA 125 in a sample from a subject (NSCLC) (e.g., paragraphs 4 and 8 – 11 and 72 – 75; Table 1), the method comprising:
providing a sample from the subject, wherein the subject is suffering from non-small cell lung carcinoma (NSCLC), and wherein the sample is a blood, a serum, or a plasma sample (paragraphs 6 and 12; claims 37 – 39); and
measuring the level of CYFRA 21-1 by contacting the sample with at least one antibody, or antigen-binding fragment thereof, that specifically binds CYFRA 21-1 and/or measuring the level of CA 125 by contacting the sample with at least one antibody, or antigen-binding fragment thereof, that specifically binds CA 125 (e.g., levels of one or more markers are determined using antibodies in a sample from a subject; paragraphs 4, 8, 9, 50 and 51; Table 1).
McKeegan does not explicitly state that the subject is under an ongoing NSCLC treatment regime and is classified to have a stable disease. It would have been obvious to a person of ordinary skill in the art to classify a patient being tested as having a stable disease prior to or at the time of biomarker measurement. It would have been obvious to a person of ordinary skill in the art to provide a method to assess the risk of disease progression and whether treatment should be maintained for a subject already showing stable disease during an ongoing treatment regime so the treatment regime would be safe and effective for the subject. The rationale to support an obviousness rejection under 35 U.S.C. 103 may rely on logic and sound scientific principle (see MPEP § 2144.02). Furthermore, the prior art can be modified or combined to reject claims as prima facie obvious as long as there is a reasonable expectation of success (see MPEP § 2143.02). The combination of familiar elements is likely to be obvious when it does no more than yield predictable results (see MPEP § 2143, A.). Furthermore, the Supreme Court decision in KSR International Co. v. Teleflex Inc., 550 U.S. 82 USPQ2d 1385 (2007) has affirmed that the threshold requirement for a prima facie case of obviousness is “demonstrating that each element was, independently, known in the prior art.” Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to provide a method comprising the steps of determining the level of the CYFRA 21-1 and/or CA 125 in a subject’s sample, and comparing the determined levels of CYFRA 21-1 and CA 125 to cut-off levels or a score or classification, and then assessing the risk of NSCLC disease progression for the subject that is under an ongoing NSCLC treatment regime and is classified to have a stable disease.
Regarding claim 28, McKeegan teaches a method of measuring a panel of biomarkers in a subject suffering from non-small cell lung carcinoma (NSCLC) (e.g., paragraphs 4 and 8 – 11 and 72 – 75; Table 1), the method comprising:
providing a sample from the subject, wherein the subject is suffering from non-small cell lung carcinoma (NSCLC), and wherein the sample is a blood, a serum, or a plasma sample (paragraphs 6 and 12; claims 37 – 39); and
determining a measurement for the panel of biomarkers in the sample, wherein the panel comprises CYFRA 21-1, CA 125, and CEA, wherein the measurement comprises determining a level of each of CYFRA 21-1, CA 125, and CEA in the panel (e.g., levels of one or more markers are determined using antibodies in a sample from a subject; paragraphs 4, 8, 9, 50 and 51; Table 1).
McKeegan does not explicitly state that the subject is under an ongoing NSCLC treatment regime and is classified to have a stable disease. It would have been obvious to a person of ordinary skill in the art to classify a patient being tested as having a stable disease prior to or at the time of biomarker measurement. It would have been obvious to a person of ordinary skill in the art to provide a method to assess the risk of disease progression and whether treatment should be maintained for a subject already showing stable disease during an ongoing treatment regime so the treatment regime would be safe and effective for the subject. The rationale to support an obviousness rejection under 35 U.S.C. 103 may rely on logic and sound scientific principle (see MPEP § 2144.02). Furthermore, the prior art can be modified or combined to reject claims as prima facie obvious as long as there is a reasonable expectation of success (see MPEP § 2143.02). The combination of familiar elements is likely to be obvious when it does no more than yield predictable results (see MPEP § 2143, A.). Furthermore, the Supreme Court decision in KSR International Co. v. Teleflex Inc., 550 U.S. 82 USPQ2d 1385 (2007) has affirmed that the threshold requirement for a prima facie case of obviousness is “demonstrating that each element was, independently, known in the prior art.” Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to provide a method comprising the steps of determining the level a panel of biomarkers in a subjects’ sample that is under an ongoing NSCLC treatment regime and is classified to have a stable disease.
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.
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BRIAN J. SINES
Primary Patent Examiner
Art Unit 1796
/BRIAN J. SINES/Primary Examiner, Art Unit 1796
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