DETAILED ACTION
Allowable Subject Matter
Claim 10, 13-19 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.
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 (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 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.
Claims 1, 2, 6-9, 11, 12, 20, and 21 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by DiGianfilippo et al. US 4789014 (“DiGianfilippo”).
Regarding Claim 1, DiGianfilippo discloses a valve unit for an installation (10) for producing a medical preparation, the valve unit comprising: a valve node (44, figs. 1 and 2) configured to be operatively mounted on the installation (10), the valve node (44) comprising a plurality of hose connections (hose connections 46); and a plurality of hoses (16), each of the plurality of hoses (16) comprising a first end (fig. 3b at line 42 in fig. 2) that is irremovably connected to a respective one of the plurality of hose connections (hose connections 46).
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DI GIANFILIPPO - FIGURES 2, 8, and 9
Regarding Claim 2, DiGianfilippo discloses each of the plurality of hoses (16) further comprises a second end (40) that comprises a source container connection (connection 40 at source container 12) that is configured to connect to a source container (12) containing ingredients for the medical preparation.
Regarding Claim 6, DiGianfilippo discloses the plurality of hose connections (hose connections 46) comprises between 4 and 20 hose connections (see fig. 3 illustrates 11 hose connections 46), inclusive.
Regarding Claim 7, DiGianfilippo discloses the valve unit comprises a lock that is configured to lock on a seat of the installation (see figs. 8 and 9; col. 10 lines 38-52 describes the locking mechanism; “ This sensing means may include a series of spring-loaded switches in the door 114 of the frame. Typically, these switches may be two-position switches which would detect the presence of an occlusion force on each of the individual fluid conduits when the door 114 is closed over the conduits. If a conduit is not in its appropriate position, or if an occlusion arm is not properly biased to include its respective conduit, a relatively low force would be detected by the two-position sensors indicating a possible malfunction of the device.”).
Regarding Claim 8, DiGianfilippo discloses the lock is configured to snap-fit on the seat of the installation (see figs. 8 and 9; col. 10 lines 38-52 describes the locking mechanism; “ This sensing means may include a series of spring-loaded switches in the door 114 of the frame. Typically, these switches may be two-position switches which would detect the presence of an occlusion force on each of the individual fluid conduits when the door 114 is closed over the conduits. If a conduit is not in its appropriate position, or if an occlusion arm is not properly biased to include its respective conduit, a relatively low force would be detected by the two-position sensors indicating a possible malfunction of the device.”).
Regarding Claim 9, DiGianfilippo discloses the valve unit comprises a housing (28), and the lock comprises an edge, at a bottom of the housing, that is configured to snap-fit on the edge of the seat of the installation to lock the valve unit to the seat of the installation (see figs. 8 and 9; col. 10 lines 38-52 describes the locking mechanism; “ This sensing means may include a series of spring-loaded switches in the door 114 of the frame. Typically, these switches may be two-position switches which would detect the presence of an occlusion force on each of the individual fluid conduits when the door 114 is closed over the conduits. If a conduit is not in its appropriate position, or if an occlusion arm is not properly biased to include its respective conduit, a relatively low force would be detected by the two-position sensors indicating a possible malfunction of the device.”).
Regarding Claim 11, DiGianfilippo discloses the valve node (44) is one of a plurality of valve nodes (44, 62, fig. 5b, and 67 fig. 6a and 6b; valve node as disclosed in claim 1 is broadly interpreted as a connector for hoses), and the plurality of valve nodes comprises between two and four valve nodes (three), inclusive.
Regarding Claim 12, DiGianfilippo discloses the plurality of valve nodes comprises three valve nodes (44, 62, fig. 5b, and 67 fig. 6a and 6b; valve node as disclosed in claim 1 is broadly interpreted as a connector for hoses).
Regarding Claim 20, DiGianfilippo discloses the valve unit is disposable (the tubes are made from material that will need to be replaced over time, thus it is disposable).
Regarding Claim 21, DiGianfilippo discloses an installation for producing a medical preparation (background), the installation comprising: a main module comprising a seat (see fig. 8, occlusion means); and the valve node (44) of claim 1 removably connectable to the seat.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 3-5 are rejected under 35 U.S.C. 103 as being unpatentable over DiGianfilippo et al. US 4789014 (“DiGianfilippo”) in view of Heinz et al. US 8231585 (“Heinz”).
Regarding Claim 3, DiGianfilippo discloses the source container connection of each second end of each of the plurality of hoses and a spike.
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HEINZ – FIGURE 3
DiGianfilippo comprises the claimed invention, except a Luer lock and the spike connected to the Luer lock.
Heinz teaches a Luer lock and a spike connected to the Luer lock (see fig. 3).
It would have been obvious to one having ordinary skill in the art at a time prior to the effective filing date to have substituted the spike at the hose, as disclosed by DiGianfilippo, with a spike connected to a Luer lock, as taught by Heinz, for the purpose of allowing a tube to be closed until initial use.
Regarding Claim 4, Heinz teaches each spike is pre-assembled to the respective Luer lock (see fig. 3).
Regarding Claim 5, Heinz teaches each spike is covered by a cap (see fig. 3).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Daphne Barry whose telephone number is (571)272-9966 and fax number is (571) 273-9966. The examiner can normally be reached on Monday through Friday 9 AM-6 PM (eastern).
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor either Kenneth Rinehart can be reached at (571) 272-4881 or Craig Schneider can be reached at (571) 272-3607. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAPHNE M BARRY/Primary Examiner, Art Unit 3753