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 .
The Amendments and Remarks filed 4/10/26 in response to the Office Action of 1/15/26 are acknowledged and have been entered.
Claim 22 has been added by Applicant.
Claims 1, 2, 5-8, 10, 11, and 19-22 are pending.
Claims 1, 2, 5, 8, 20, and 22 have been amended by Applicant.
Claims 1, 2, 5-8, 10, 11, and 19-22 are currently under consideration.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
This Office Action contains New Rejections Necessitated by Amendments.
Rejections Withdrawn
The rejections under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, are withdrawn.
The rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, are withdrawn.
Rejections Maintained
Claim Rejections - 35 USC § 103
Claims 1, 5-7 and 19 remain rejected and claims 10, 11, and 22 are rejected under 35 U.S.C. 103(a) as being unpatentable over Thierry et al (WO 2012/028746 A1; 3/8/12) in view of Labianca et al (Critical Reviews in Oncology/Hematology, 2004, 51: 145-170).
Thierry et al teaches circulating DNA of healthy patients seems clearly constituted of fragment <138 bp and >300 bp with no apparent fragment between 138 bp and 300 bp (lines 13-14 on page 72, in particular). Thierry et al demonstrates a method of distinguishing colorectal cancer patients from healthy patients comprising extracting cell free DNA from a sample (a blood sample) obtained from a subject, determining levels of single stranded DNA fragment having lengths of between 145 nucleotides (including a length of 145 bp) obtained by denaturing the cell free DNA and performing PCR and demonstrating single stranded DNA of length of 145 bp is detected in samples from colorectal cancer patients (“gastrointestine cancer” patients) at much higher levels than samples from healthy patients (Example VI and Figure 18, in particular).
Thierry et al does not explicitly describe administering a particular cancer therapy after diagnosing a subject as having colorectal cancer. However, these deficiencies are made up in the teachings of Labianca et al.
Labianca et al teaches colorectal cancer patients are known to therapeutically benefit from chemotherapy, radiotherapy, and immunotherapy (pages 155-163, in particular).
One of ordinary skill in the art would have been motivated, with an expectation of success, to perform the method of Thierry et al to screen a subject for colorectal cancer wherein cell free DNA is extracted from a sample (a blood sample) obtained from a subject, levels of single stranded DNA fragment having a length of 145 bp are determined by denaturing the cell free DNA and performing PCR, and the levels of single stranded DNA fragment having a length of 145 bp in the sample are compared to with a predetermined reference level of single stranded DNA fragment having a length of 145 bp in a corresponding sample from a healthy control, and concluding that the subject has colorectal cancer and diagnosing the subject as having colorectal cancer when levels of single stranded DNA fragments having a length of 145 bp are higher in the sample from the subject as compared to the level in the corresponding sample from a healthy control because Thierry et al teaches single stranded DNA of length of 145 bp is detected at a much higher level in samples from colorectal cancer patients as compared to samples from healthy patients (Example VI and Figure 18, in particular). Regarding instant claims 11, 12, and 22, said method of Thierry et al is equivalent to recited methods of screening for “lung” cancer.
One of ordinary skill in the art would have been further motivated, with an expectation of success, to provide therapeutic benefit by diagnosing and treating a subject with colorectal cancer comprising performing said method to diagnose subjects with colorectal cancer and administering chemotherapy, radiotherapy, and/or immunotherapy of Labianca et al to those subjects diagnosed as having colorectal cancer because Labianca et al teaches colorectal cancer patients are known to therapeutically benefit from chemotherapy, radiotherapy, and immunotherapy (pages 155-163, in particular).
In particular regards to instant claim 7, one of ordinary skill in the art would have been further motivated, with an expectation of success, to perform said method wherein the screening is again performed after therapeutic treatment in order to determine whether cancer remains or there is relapse after the treatment and repeat administration of the therapeutic treatment if levels of single stranded DNA are increased after the treatment because the screening detects the presence of the cancer, an increase in single stranded DNA of the screening would indicate a relapse of the cancer, and the treatment therapeutically treats the cancer.
Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art, absent unexpected results.
Response to Arguments
In the Reply of 4/10/26, Applicant argues cited references do not disclose measuring fragment lengths that are in the ranges of 88 to 100 and/or 140 to 240 nucleotides and there is no combination of cited references that make the claims obvious.
The amendments to the claims and the arguments found in the Reply of 4/10/26 have been carefully considered, but are not deemed persuasive. In regards to the argument that cited references do not disclose measuring fragment lengths that are in the ranges of 88 to 100 and/or 140 to 240 nucleotides and there is no combination of cited references that make the claims obvious, the examiner disagrees. Thierry et al demonstrates a method of distinguishing colorectal cancer patients from healthy patients comprising extracting cell free DNA from a sample (a blood sample) obtained from a subject, determining levels of single stranded DNA fragment having lengths of between 145 nucleotides (including a length of 145 bp) obtained by denaturing the cell free DNA and performing PCR and demonstrating single stranded DNA of length of 145 bp is detected in samples from colorectal cancer patients (“gastrointestine cancer” patients) at much higher levels than samples from healthy patients (Example VI and Figure 18, in particular). Further, the claimed method is rendered obvious for the reasons stated above. Figure 18 is shown below with arrows:
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New Rejection Necessitated by Amendments
Claim Rejections - 35 USC § 112
Claims 1, 2, 5-8, 10, 11, and 19-22 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a NEW MATTER rejection.
Claim 1 recites methods of screening and treating a subject for cancer comprising measuring a level of single stranded DNA fragment(s) having a length from 88 to 100 and/or 140 to 240 nt and administering one or more cancer treatments to a subject as having a higher or lower level than at least one corresponding predetermined reference value. Descriptions of methods of screening and treating a subject for cancer comprising measuring a level of single stranded DNA fragment(s) having a length from 88 to 100 and/or 140 to 240 nt and administering one or more cancer treatments to a subject as having a higher or lower level than at least one corresponding predetermined reference value are not found in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventors, at the time the invention was filed, had possession of the claimed invention. Further, descriptions of said method wherein the cancer is “lung cancer” (see claims 10, 11, and 13) are certainly not found in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventors, at the time the invention was filed, had possession of the claimed invention.
Claim 2 recites methods further measuring and calculating ratios of first and second single stranded DNA fragments wherein the first single stranded DNA fragment has a length ranging from 88 to 100 and the second single stranded DNA fragment has a length ranging 140 to 240 nt. Descriptions of methods further measuring and calculating ratios of first and second single stranded DNA wherein the first single stranded DNA fragment has a length ranging from 88 to 100 and the second single stranded DNA fragment has a length ranging 140 to 240 nt are not found in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventors, at the time the invention was filed, had possession of the claimed invention.
Response to Arguments
In the Reply of 4/10/26, Applicant indicates support for the claimed methods is provided by the specification because nucleotide fragments of recited lengths are disclosed in the specification.
The amendments to the claims and the arguments found in the Reply of 4/10/26 have been carefully considered, but are not deemed persuasive. In regards to the indication support for the claimed methods is provided by the specification because nucleotide fragments of recited lengths are disclosed in the specification, the examiner disagrees. While the specification may mention fragments of sizes encompassed by the claims, the specification does not disclose the claimed methods.
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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/SEAN E AEDER/Primary Examiner, Art Unit 1642
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