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 § 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 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, 5-6, and 14 is/are rejected under 35 U.S.C. 102(a1/a2) as being anticipated by Summerton et al., WO 2005/118485 (Summerton, IDS).
Regarding claim 1, Summerton discloses a drain apparatus (REF 190, fig. 5) for a dialysis system (abstract, REF 100, figs. 1-7) comprising:
A chamber (bottom REF 10, fig. 5) configured to receive an end of a fluid line (REF 210) extending from the dialysis machine;
A lid (top REF 10, fig. 5) configured to be coupled to the chamber to form a seal with the chamber (via REF 192);
An inlet line (REF 210 upstream of REF 190) having a first end configured to be coupled to the chamber and a second end configured to be coupled to a fluid line of the dialysis machine (fig. 5);
An outlet line (REF 210 downstream of REF 190) having a first end configured to be coupled to the chamber and a second end configured to be fluidly coupled to the drain line of the dialysis machine; and
A valve (REF 179) coupled to the outlet line and configured to control flow of fluid through the outlet line.
The examiner notes applicant’s language drawn to multiple uses of “configured to be coupled” merely requires the fluidic connections to be capable of being made in the prior art to be considered as configured to be coupled. As such, the examiner relies on the multiple embodiments in Summerton (as seen above and below) to anticipate the rejected claims, where the multiple fluidic connections are shown as capable according to the multiple embodiments shown in Summerton.
Regarding claim 5, Summerton discloses a drain apparatus further comprising a pump (REF 220, fig. 5) coupled to the outlet line (REF 210).
Regarding claim 6, Summerton discloses a drain apparatus further comprising one or more mechanical attachment devices (REF 60, fig. 1) coupled to the chamber and configured to position an end of a patient line extending from the dialysis machine inside the chamber.
Regarding claim 14, Summerton discloses a drain apparatus wherein the lid comprises one or more vent holes (REF 80, figs. 2-3).
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 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 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Summerton in view of Weaver et al., US 2011/0163030 (Weaver, IDS).
Regarding claim 7, Summerton does not explicitly disclose a system wherein the drain apparatus lid includes a vent and a hydrophobic filter disposed within the vent. However, Weaver discloses a dialysis system (abstract, figs. 1-8) comprising a fluidic reservoir (REF 112) that includes a vent (REF 150, figs. 5-6) within said fluidic reservoir, wherein said vent further includes a hydrophobic filter (REF 148, ¶ 0081).
At the time of invention it would have been obvious to one having ordinary skill in the art to modify the drain apparatus of Summerton to include a vent and hydrophobic filter as described in Weaver in order to prevent air from entering the fluidic lines and to control fluidic pressure as a consequence of differential pumping flow rates (¶ 0074).
Claims 8, 10, and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Summerton in view of Okazaki et al., US 2006/0124548 (Okazaki).
Regarding claim 8, Summerton does not disclose the drain apparatus comprising a sensor configured to detect a fluid level in the chamber. However, Okazaki discloses dialysis systems (abstract, fig. 1) comprising a variety of containers (REF 8, 9, 10) including a drain container (REF 8, ¶ 0007), where each of the variety of containers comprise a level sensor to detect a fluid level within the chamber (REF 11, 12, 13, ¶ 0026).
At the time of invention, it would have been obvious to one having ordinary skill in the art to modify the drain apparatus of Summerton to include a level sensor as described in Okazaki in order to ensure a minimum or maximum fluid threshold is maintained within a fluid container.
Regarding claim 10, Okazaki further discloses the sensor comprises an ultrasound sensor coupled to the chamber (¶ 0051).
Regarding claim 13, Okazaki discloses the sensor comprises one or more electrodes coupled to the chamber (¶ 0051).
Claims 9 and 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Summerton in view of Okazaki as relied upon in the rejection of claim 8 set forth above, and in further view of Parisotto et al., US 2016/0250406 (Parisotto).
Regarding claim 9, while Summerton (in view of Okazaki) discloses sensors coupled to the drain container comprising a variety of sensors (Okazaki, ¶ 0051), Summerton (in view of Okazaki) does not disclose the sensor comprising a pressure sensor coupled to the outlet line. However, Parisotto discloses dialysis systems (abstract, fig. 1) comprising a drain container (REF 19) having a pressure sensor (REF 19h) coupled to an outlet line of the drain container.
At the time of invention, it would have been obvious to one having ordinary skill in the art to modify the drain apparatus of Summerton (in view of Okazaki) to include a pressure sensor as described in Parisotto since it has been shown that pressure sensors are routinely used in dialysis drain systems and the incorporation of such a sensor would be within the level of one having ordinary skill in the art.
Regarding claims 11-12, Summerton (in view of Okazaki) discloses the level sensor comprising an ultrasonic or light sensor coupled to the chamber (Okazaki, ¶ 0051). While Summerton (in view of Okazaki) does not disclose the sensors being coupled to a lid of the drain apparatus, Parisotto discloses that sensors coupled to the lid of a drain apparatus is common (REF 19, fig. 1).
At the time of invention, it would have been obvious to arrange the sensor assemblies of Summerton (in view of Okazaki) as described in Parisotto since it has been shown that the location and placement of said sensors can be arranged in a variety of locations including a drain apparatus lid, and rearrangement of such parts involves only routine skill in the art (MPEP 2144.04, Section VI, Part C).
Allowable Subject Matter
Claims 2-4 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DIRK R BASS whose telephone number is (571)270-7370. The examiner can normally be reached 8-4:30 EST Monday-Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bobby Ramdhanie can be reached on (571) 270-3240. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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DIRK R. BASS
Primary Examiner
Art Unit 1779
/DIRK R BASS/Primary Examiner, Art Unit 1779
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