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 .
DETAILED ACTION
Allowable Subject Matter
Claims 8-20 are allowed.
The following is a statement of reasons for the indication of allowable subject matter: claims 8 and 15 recite “controller configured to initiate a scrub timer…being the blood collection process after the scrub time period has elapsed”. Indicating there is no user involvement, and the scrub timer timing function is used to determine the start of the blood collection process automatically.
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.
Claim(s) 1-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Goodnow (US 20120265099) in view of Philpot (US 4083363).
Regarding claim 1, Goodnow discloses A blood collection device, comprising: a blood collection bag (118); a valve (114) configured to engage a tube leading from the blood collection bag to a patient (paragraph 0034, 0038) (Fig 1b): a controller (108) configured to control the blood collection device including the valve (paragraph 0046). Goodnow discloses all of the limitations of the claim except a scrub timer operatively coupled to the controller and configured to indicate to a user a scrub time period prior to beginning a blood draw process. However Goodnow teaches in paragraph 0041 the use of a timer “…and various other timing and flow functions can be activated…”, in paragraph 0042, Goodnow teaches adhering to standard blood operation procedures.. “since blood bank standards require that blood collections must be completed in a set period of time…”, in paragraph 0049, Goodnow teaches displaying the status of the device which would make it capable of displaying “scrub” and paragraph 0050 notes that there a “time” column on the display. Philpot teaches a blood withdrawal device with the use of a programmable timer (38) that could be set according the blood collection standards such as a scrub time. Therefore, it would have been obvious at the effective filing date of the invention to modify Goodnow by Philpot to include a programmable timer to ensure absolute adherence to blood collection time standards and therefore, ensuring utmost quality of the blood specimen and preventing laboratory/user error. Furthermore, the use of a timer to automatically manage the manual process of managing the scrubbing time prior to blood withdrawal is found to be obvious. This is because automation e.g. use of a timer to perform other wise known manual methods (phlebotomist using a clock or watch to manage scrubbing time) is not an unobvious variation from the teachings of prior art wherein automation was not performed. In other words, broadly providing an automatic or mechanical means to place a manual activity which accomplished the same result is not sufficient to distinguish over the prior art (see In re Venner, 262 f.2d 91, 95, 120 USPQ 193, 194 ((CCPA 1958)).
Regarding claim 2, Goodnow discloses The blood collection device of claim 1, wherein the valve comprises a pinch valve (114) (paragraph 0034, 0038).
Regarding claim 3, Goodnow discloses all of the limitations of the claim except The blood collection device of claim 1, further comprising an audible output configured to emit one or more audible beeps during the scrub time period. Philpot teaches an audible output configured to emit one or more audible beeps during the scrub time period (col. 3, lines 50-54, col. 4, lines 25-31). Therefore, it would have been obvious at the effective filing date of the invention to modify Goodnow by Philpot to include a programmable timer with audible notifications to ensure absolute adherence to blood collection time standards and therefore, ensuring utmost quality of the blood specimen and preventing laboratory/user error.
Regarding claim 4, Goodnow discloses The blood collection device of claim 1, further comprising a graphical user interface (paragraph 0035).
Regarding claim 5, Goodnow discloses The blood collection device of claim 4, wherein the graphical user interface is configured to visibly count down the time period (paragraph 0049-0050). Goodnow discloses all of the limitations of the claim except a scrub timer. Philpot teaches a blood withdrawal device with the use of a programmable timer (38) that could be set according the blood collection standards such as a scrub time. Therefore, it would have been obvious at the effective filing date of the invention to modify Goodnow by Philpot to include a programmable timer to ensure absolute adherence to blood collection time standards and therefore, ensuring utmost quality of the blood specimen and preventing laboratory/user error.
Regarding claim 6, Goodnow discloses the blood collection device of claim 4, wherein the graphical user interface is configured to receive an input from the user (paragraph 0035). Goodnow discloses all of the limitations in the claim except initiate the scrub time period in the scrub timer. Philpot teaches a blood withdrawal device with the use of a programmable timer (38) that could be set according the blood collection standards such as a scrub time. Therefore, it would have been obvious at the effective filing date of the invention to modify Goodnow by Philpot to include a programmable timer to ensure absolute adherence to blood collection time standards and therefore, ensuring utmost quality of the blood specimen and preventing laboratory/user error.
Regarding claim 7, Goodnow discloses The blood collection device of claim 4, wherein the time period is visually displayed on the graphical user interface (paragraph 0050). Goodnow discloses all of the limitations in the claim except a scrub timer. Philpot teaches a blood withdrawal device with the use of a programmable timer (38) that could be set according the blood collection standards such as a scrub time. Therefore, it would have been obvious at the effective filing date of the invention to modify Goodnow by Philpot to include a programmable timer to ensure absolute adherence to blood collection time standards and therefore, ensuring utmost quality of the blood specimen and preventing laboratory/user error.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YASMEEN S WARSI whose telephone number is (571)272-9942. The examiner can normally be reached Monday-Friday 9 am to 5 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Valvis can be reached at 571-272-4233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/YASMEEN S WARSI/Examiner, Art Unit 3791
/MAY A ABOUELELA/Primary Examiner, Art Unit 3791