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 § 103
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.
Claims 14-17, 19-25, 27-31 and 33-34 are rejected under 35 U.S.C. 103 as being unpatentable over Simpson [US 7762989 B2] in view of Chapman et al [US 8882700 B2].
As for claim 14, Simpson discloses a dialysis system (column 5, lines 44-51), comprising:
an identification system including an identification sensor (16) configured to read a device identifier included on a disposable component, wherein the disposable component is configured to introduce or remove solution from a patient during an exchange treatment of the dialysis system (column 5, lines 44-51 (dialysis system), column 7, lines 5-51, column 8, lines 9-27 (suggests one-time use, disposable)),
wherein the identification system is configured to determine whether to execute the exchange treatment using the disposable component based, at least in part, on the device identifier (column 8, lines 5-27 and 57-61).
While Simpson discloses the using the invention with a dialysis system (see above), Simpson is silent on an automated peritoneal dialysis system. In an analogous art, Chapman discloses that it was known in the art for an automated peritoneal dialysis system (APD) to include a disposable component having a device identifier (column 2 and column 17, lines 39-55). Having each of the references on hand, it would have been obvious to the skilled artisan that the APD taught by Chapman could be substituted for the dialysis system of Simpson. This appears to be a simple substitution of a specialized infusion system (APD) for another infusion system. Since each of the inventions are focused on dialysis treatment the skilled artisan would have expected reasonable success when modifying the invention of Simpson to include the APD system of Chapman.
As for claim 15, a mount configured to receive the disposable component (Simpson discloses the use of commonly used cassette pumps. This teaching implies that the cassettes would be the disposable component. A mount must be in place to receive the component (column 5, lines 33-43). Likewise, Chapman discloses that it was known in the art for the system to include a mount (column 17, lines 32-39).
As for claim 16¸ the claim is interpreted and rejected using the same reasoning as claims 14-15 above. It would have been obvious to the skilled artisan that the identification sensor should be place in close relation with the mount because the disposable component must be placed adjacent the mount. The placement of the identification sensor in proximity of the mount would make sense because it would ensure that the sensor could efficiently and effectively detect the identifier associated with the disposable component.
As for claim 17, the claim is interpreted and rejected using the same reasoning as claims 14-16 above. The skilled artisan would have recognized that the disposable component is typically punctured as the mounts the disposable component.
Claim 19 is interpreted and rejected using the same reasoning as claims 14-16 above.
As for claim 20, Simpson discloses that the device identifier is a radiofrequency identification (RFID) device, a quick response (QR) code, a near-field communication (NFC) device, or a digitally readable number (columns 7 and 8).
As for claim 21, Simpson discloses that the device identifier is a marking of text on a surface of the cassette (column 7).
As for claim 22, the claim is interpreted and rejected using the same reasoning as claims above.
As for claim 23, Simpson discloses that the identification sensor is an image sensor, a camera, a scanner, a radiofrequency (RF) receiver, or a near-field communication (NFC) reader (columns 7 and 8).
As for claim 24, Simpson discloses that one or more remote servers or databases storing a whitelist of valid device identifiers (column 8).
As for claims 25 and 27, the claim is interpreted and rejected using the same reasoning as claim 24 above.
Claims 28-30 is interpreted and rejected using the same reasoning as the claims above. See Simpson column 8.
As for claim 31, Simpson discloses storing a local copy of a whitelist of valid device identifiers stored on one or more remote servers or databases and syncing the local copy with a whitelist of valid device identifiers stored on one or more servers or databases remote from the APD system (column 8, lines 28-46).
Claims 33 and 34 are interpreted and rejected using the same reasoning as claims 14, 20, 27, and 31 above.
Claims 18 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Simpson in view of Chapman et al as applied to the claims above, and further in view of Plahey et al [US 7935074 B2].
As for claim 18¸ while Simpson and Chapman both disclose reading identifier information when the disposable component comes into range of the identifying device, each invention is silent on the claimed lock feature. In an analogous art, Plahey discloses a dialysis machine wherein the cassette device is locked into the machine (column 5, lines 57-67). It would have been obvious to the skilled artisan to modify Simpson and Chapman to include a locking feature as taught by Plahey in order to yield the predictable results of a system or method wherein, prevent cassette from being accidentally displaced or from tampering by a user.
Claim 32 is interpreted and rejected using the same reasoning as claim 18 above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Each of the cited references discloses either infusion pump systems or dialysis systems that were known in the art at the time of filing the instant application.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIC M BLOUNT whose telephone number is (571)272-2973. The examiner can normally be reached M-F 9:00a - 5:30p.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Quan Wang can be reached at 571-272-3114. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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ERIC M. BLOUNT
Primary Examiner
Art Unit 2685
/Eric Blount/ Primary Examiner, Art Unit 2685