Detailed Action
► The applicant's response (filed 17 FEB 06) to the Office Action has been entered. Following the entry of the claim amendment(s), Claim(s) 1-4, 6-8, 10-19 and 22-34 is/are pending. Rejections and/or objections not reiterated from the previous office action are hereby withdrawn. The following rejections and/or objections are either newly applied or reiterated. They constitute the complete set presently being applied to the instant application.
► The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . 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 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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim Rejections under 35 USC § 103
► Claim(s) 1-11, 13-15 and 17-32 is/are rejected under 35 U.S.C. 103(a) as being unpatentable over Kanaoka et al. [US 2006/0216714 - hereinafter "Kanaoka"] in view of Shuber et al.[WO 2005/113769 i- hereinafter "Shuber"] ; Lenhard et al. [Clin. Gastroenterology. and Hepatology 3: 142-149 (2005) - "Lenhard"] ; Vilkins et al. [AM J. of Gastroenterology 100 : 2519-2525 (2005) - hereinafter "Vilkins"] ; Itzkowitz et al. [Clin. Gastroenterology and Hepatology (2007) - "Itzkowitz"] ; Koga et al. [Cancer Science 99(10) :1977-1983 (2008) - hereinafter Koga and Sugo [US/2010/0216178 - Sugo] for the reason(s) of record.
As regards Claim(s) 31-32, Colonoscopy was a well known (Official Notice) method of . screening and treatment for adenomas (i.e. CRC) and was routinely performed on patients with positive iFOT and/or positive NA testing results prior to the instant invention.
Response to Applicant’s Amendment / Arguments
► Applicant's arguments with respect to the claimed invention have been fully and carefully considered but are deemed non-persuasive.
The applicant begins their remarks by traversing the rejection of Claim 1 and 24 (i.e. Claims 1-32 - i.e. independent Claims 1 and 24) under 35 U.S.C. 103(a) as being unpatentable over Kanaoka et al. [US 2006/0216714 - hereinafter "Kanaoka"] in view of Shuber et al.[WO 2005/113769 i- hereinafter "Shuber"] ; Lenhard et al. [Clin. Gastroenterology. and Hepatology 3: 142-149 (2005) - "Lenhard"] ; Vilkins et al. [AM J. of Gastroenterology 100 : 2519-2525 (2005) - hereinafter "Vilkins"] ; Itzkowitz et al. [Clin. Gastroenterology and Hepatology (2007) - "Itzkowitz"] ; Koga et al. [Cancer Science 99(10) :1977-1983 (2008) - hereinafter Koga] and Sugo [US/2010/0216178 – hereinafter Sugo].
As regards Independent Claim(s) 1 and 24, the applicant argues, in part, that the ordered steps of Claim(s) 1 and 24 distinguish over the prior art of record. In particular, the applicant argues that the limitation(s) in steps (c) -(d) of Claim 1 and steps (b) – (c) of Claim 24 both require nucleic acid testing (i.e. hereinafter “NA testing”) only in the presence of a negative iFOB test and that this distinguishes over the prior art of record. This confirmatory testing discussed above may be referred to a “Reflex testing” in the remainder of this Office Action. Clearly, the prior art of record does not expressly teach the referenced “distinguishing limitation” (i.e. the Reflex testing). In addition, it is noted that the Genoscopy decision referenced in the Non-Final Office Action is silent as regards this limitation.
One well known risk factor for false negative iFOBs is/are the finding that colon cancers may only bleed intermediately. iFOB is not a foolproof indicator of cancer. Digestive tract bleeding can be intermittent, and negative results can and do occur in subjects who have colorectal cancer. For example, consider the para entitled “Fecal Occult Blood Testing” on pg. 14 of the Report presented OCT 2008 to the Ontario Health Technology Advisory Committee wherein the authors teach that intermittent bleeding can and does occur in some patients with CRC It was also well known (Official Notice) that NA testing for CRC is generally more costly and sensitive than iFOB. Thus the POSA , knowing the significant incidence of false positive/negative error rate associated with iFOT, would have been motivated to carry out additional confirmatory testing on those samples having a negative iFOT in order to catch iFOT negative cancer demonstrating intermittent bleeding (i.e. the POSA would have been motivated to perform the reflex testing of Claims 1 and/or 24 Such an approached is considered to be a simple design choice (i.e. a preference of choice) well within the knowledge, skill, abilities and common sense of the POSA at the time of the invention.
New Grounds of Rejection Necessitated by Amendment
Claim Rejections under 35 USC § 103
► Claim(s) 33-34 is/are rejected under 35 U.S.C. 103(a) as being unpatentable over
Kanaoka et al. [[US 2006/0216714 – hereinafter Kanaoka] in view of Yee et al. [2008/0227208 – hereinafter “Yee”] and Nakamura [US 2008/0199468 – hereinafter “Nakamua”].
Claim 34 is drawn to a method of testing a human subject for presence of a colorectal malignancy and/or pre-malignancy, comprising: immunochemically testing a fecal sample from the human subject using anti- hemoglobin antibodies to determine a concentration of hemoglobin, wherein a concentration of hemoglobin in the fecal sample is indicative that the fecal sample is positive for presence of blood; and if the concentration of hemoglobin determined in a) does not indicate that the b) fecal sample is positive for the presence of blood, detecting human nucleic acid from the fecal sample.
Kanaoka teach, see the entire 7 pg document , both iFOB and NA testing for CRC. Kanaoka further teach colonscopy , see especially para 5. Finally, Kanaoka teach, see at least para 57, dividing stool samples into smaller portions prior to CRC testing said individual portions. That said Kanaoka, and indeed, none of the prior art cited expressly teach the reflex testing aspect encompassed by the instant claims.
Yee teaches, see the entire document, iFOB (i.e. testing a human subject for presence of a colorectal malignancy and/or pre-malignancy, comprising: immunochemically testing a fecal sample from the human subject using anti- hemoglobin antibodies to determine a concentration of hemoglobin) while Nakamura teach NA testing. Thus the prior art makes clear the both iFOB and NA testing approaches for detecting/screening for CRC were known with a slight advantage in sensitivity obtained by NA testing, see Imperale et al. [NEJM 351 (26) :2704-2714(2004)- hereinafter “Imperale”].
It was also known that colonoscopy is a significant impediment to CRC screenings and patient compliance for colonoscopy, given the high cost, discomfort, and invasiveness of this procedure (Beydoun et al., “Predictors of Colorectal Cancer Screening Behaviors Among Average-risk Older Adults in the United States,” Cancer Causes & Control. CCC 19(4):339-359 (2008)). Finally it is noted (Official Notice) that the cost of performing NA testing is significantly more than iFOB testing owning in part to the fact that the hands of skilled technicians and more expensive test reagents are needed.
As noted above, none of the prior art of record appear to teach the reflex testing aspect of Claim 32. However, given the well known inadequacies with iFOB, it would have been prima facie obvious to the POSA to modify the method Kanaoka wherein when a negative iFOB is obtained, a more sensitive NA test is subsequently employed. Such a modification ,is considered to be a simple design choice (i.e. a preference of choice) well within the knowledge, skill, abilities and common sense of the POSA at the time of the invention. The POSA would have been further motivated to make the modification recited above given the well known inadequacies with iFOB. It would have been prima facie obvious to the POSA to utilize the iFOB test as a quick and easy screening test for CRC before resorting to more costly tests/procedures.
Claim 34 is drawn to an embodiment of the method of Claim 33, wherein the concentration of hemoglobin is determined by testing a first portion of the fecal sample and wherein in step b), if conducted, human nucleic acid is detected from a second portion of the fecal sample.
Kanaoka clearly teach/suggest independent testing on divided portions of a stool sample, see paras 57-59.
Conclusion
C1. Applicant's amendment necessitated the new grounds of rejection. Accordingly, THIS ACTION IS MADE FINAL. See M.P.E.P. § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 C.F.R. § 1.136(a).
A SHORTENED STATUTORY PERIOD FOR RESPONSE TO THIS FINAL ACTION IS SET TO EXPIRE THREE MONTHS FROM THE DATE OF THIS ACTION. IN THE EVENT A FIRST RESPONSE 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 EXTENSION FEE PURSUANT TO 37 C.F.R. § 1.136(a) WILL BE CALCULATED FROM THE MAILING DATE OF THE ADVISORY ACTION. IN NO EVENT WILL THE STATUTORY PERIOD FOR RESPONSE EXPIRE LATER THAN SIX MONTHS FROM THE DATE OF THIS FINAL ACTION.
C2. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ethan Whisenant whose telephone number is (571) 272-0754. The examiner can normally be reached Monday-Friday from 8:30 am -5:30 pm EST or any time via voice mail. If repeated attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Anne Gussow, can be reached at (571) 272-6047.
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/ETHAN C WHISENANT/Primary Examiner, Art Unit 1683 ethan.whisenant@uspto.gov