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
Applicant’s request for continued examination filed December 18, 2025 is acknowledged. Claims 1, 7, 13, 23, and 26-27 are amended, claims 5, 12, and 16-20 are canceled, and claim 28 is newly added. Claims 1-4, 6-11, 13-19, and 21-28 are pending and further considered on the merits.
Response to Amendment
In light of applicant’s amendment, the examiner maintains the grounds of rejection set forth in the office action filed September 19, 2025.
Claim Rejections - 35 USC § 103
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(s) 1-4, 6-9, 15, 21-22, 24-25, and 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Richards et al., US 5439586 (Richards, of record) in view of Christensen, US 4772383 (Christensen).
Regarding claim 1, Richards discloses a filter for blood components (abstract, figs. 1-4, C5/L53-60) comprising:
A main body (fig. 1) comprising a top side (proximate to REF 20), a bottom side (proximate to REF 44), and a lateral side (side connecting REF 20 to REF 33) defining a chamber (REF 10);
An outside height dimension between said top side and said bottom side of said main body (from REF 20 to REF 44, fig. 1), said main body comprising an outside width dimension (i.e. diameter of REF 10, fig. 1), the outside height dimension being equal to or greater than said outside width dimension (fig. 1);
A support structure for placing a magnet device (REF 12, fig. 1, C3/L30-35) proximate to the main body (see “longitudinal configuration”, C10/L14-17);
An inlet (REF 20) disposed on said top side and an outlet (REF 44) disposed on said bottom side (fig. 1); and
A filter (REF 10) disposed in said chamber and comprising a filter media comprising a filter membrane (REF 24/26, C3/L64-C4/L9) configured to receive an electric charge and/or be electromagnetically charged (see “magnetisable wire mesh”, C3/L64-C4/L9) and capable of capturing or trapping undesired matter (via size exclusion).
While Richards discloses the main body (REF 10) mounted within the magnet device (REF 12, fig. 1, C3/L30-35, C10/L14-17), Richards does not disclose the device comprising a support structure for removably securing the magnet device. However, Christensen discloses a filter device (abstract, figs. 1-3) comprising a main body (REF 9) and a support structure (REF 5-8, fig. 1, see “yoke members”, C5/L21-26) for removably securing a magnetic device (REF 1, 2) to said main body.
At the time of invention, it would have been obvious to one having ordinary skill in the art to modify the device of Richards to include the support structure as described in Christensen in order to magnetically connect and support magnet devices surrounding a filter media in a desired position and orientation.
Regarding claim 2, Richards (in view of Christensen) discloses a filter wherein said filter media comprises a border (edge of REF 24/26, figs. 1, 4).
Regarding claim 3, Richards (in view of Christensen) discloses a filter wherein said main body and chamber comprises a central axis, said filter media comprising a plurality of layers of filter media (REF 24/26, fig. 1) disposed on parallel planes oriented perpendicular to said central axis (fig. 1).
Regarding claim 4, Richards (in view of Christensen) discloses a device wherein said filter media comprises a nested configuration (REF 24 at REF 16 between REF 22, 42, fig. 1).
Regarding claim 6, Richards (in view of Christensen) discloses a device comprising a magnet device (REF 12, C3/L30-35) disposed proximate to said filter (fig. 1).
Regarding claim 7, Christensen further discloses the support structure (REF 5-8, fig. 1) comprising an electrically conductive bridge (REF 5-8, see “yoke members”, C5/L21-26) for removably securing the magnetic device.
Regarding claim 8, Richards (in view of Christensen) discloses a filter wherein said lateral side comprises a curved shape, and said main body and said chamber comprises a cylindrical shape (REF 10, fig. 1).
Regarding claim 9, Richards (in view of Christensen) discloses a device wherein said filter media comprises a plurality of magnetic beads (“magnetizable particles”, C6/L21-42).
Regarding claim 15, Richards (in view of Christensen) discloses a device further comprising a plurality of baffles (REF 26) defining a plurality of baffle channels (region between REF 26) which are configured in a series in said chamber, each of said plurality of baffle channels being in fluid communication with each other of said plurality of baffle channels through a plurality of openings (i.e. mesh openings) configured in a series wherein consecutive openings within the series are laterally spaced apart throughout the series (laterally spaced from left/right), said plurality of baffle channels and said plurality of openings together providing a flow path having a length, whereby the length of the flow path of blood or blood component is greater than said outside height dimension (due to conical shape, turbulence, flow path blockages, etc. fig. 1).
Regarding claim 21, Christensen further discloses a device comprising a top side having a removable top portion (REF 7), whereby said filter is capable of being removed.
Regarding claim 22, Christensen further discloses a device comprising a first magnet device (REF 7) disposed on said top side, and a second magnet device disposed on said bottom side (REF 8), and an electrically conductive bridge structure (REF 5, 6) extending there-between and thereby magnetically and mechanically coupling said first magnet device and said second magnet device (figs. 1-2), whereby said first magnet device, said second magnet device, and said electrically conductive bridge structure can be attached and also removed from said main body and recycled (implicitly disclosed).
Regarding claim 24, Christensen further discloses a device comprising stop valves (REF 79, 80, fig. 19) for regulating fluid flow.
Regarding claim 25, Richards (in view of Christensen) discloses a device further comprising a pump device (see “peristaltic pump”, C10/L41-44).
Regarding claim 28, Richards (in view of Christensen) is relied upon in the rejection of claims 1 and 15 set forth above.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Richards in view of Christensen as relied upon in the rejection of claim 1 set forth above, and in further view of Miltenyi et al., US 5691208 (Miltenyi, IDS).
Regarding claim 10, Richards (in view of Christensen) does not disclose the mesh or screen pore size being smaller than 30 microns. However, Miltenyi discloses magnetic separation devices for biological fluids such as blood (abstract) comprising a filtration material having an average pore size of about 20 microns (C7/L36-64, C8/L59-67).
At the time of invention, it would have been obvious to one having ordinary skill in the art to modify the filter of Richards (in view of Christensen) to have a filtration material pore size as described in Miltenyi since it has been shown that such pore sizes are effective in fractionating biological materials, and since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art absent a showing of criticality or unexpected results (MPEP 2144.05, Section II, Part A).
Claim(s) 11, 23, and 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Richards in view of Christensen as relied upon in the rejection of claim 1 set forth above, and in further view of Jessen et al., US 2011/0077144 (Jessen).
Regarding claim 11, Richards does not disclose a filter having a tube comprising a splitter disposed proximate to said inlet and extending about a central axis, the tube comprising an opening proximate to and being in fluid communication with the outlet and inlet and aligned with said inlet/outlet, the filter material disposed concentrically about the central axis in said chamber. However, Jessen discloses that it is common practice to implement a perforated tube having a splitter (REF 46, fig. 2) disposed proximate to an inlet (REF 44) and extending about a central axis, the tube further comprising an opening (see ‘bottom’ of REF 47) proximate to and being in fluid communication with the outlet (REF 52) and inlet (REF 44) and aligned with said inlet and outlet (fig. 2), where filter media (REF 22) is disposed concentrically about the tube.
At the time of invention, it would have been obvious to one having ordinary skill in the art to modify the filter of Richards to include a central tube as described in Jessen since such configurations are very well known in the separations art for their ability to deliver fluid to surrounding media while minimizing pressure drop and maximizing fluid exposure to said surrounding media.
Regarding claim 23, Jessen further discloses the splitter being a dispersion device (see flow paths 42, 45, fig. 2).
Regarding claim 26, Richards (in view of Christensen and Jessen) is relied upon in the rejection of claims 1 and 11 set forth above. Jessen further discloses the splitter disposed at an acute angle (see bottom of REF 44 proximate REF 47) relative to and proximate an inlet (fig. 2)
Claim(s) 13-14 and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Richards in view of Christensen as relied upon in the rejection of claim 1 set forth above, and in further view of Kutushov, US 5980479 (Kutushov, IDS).
Regarding claim 13, Richards (in view of Christensen) discloses a filter device for blood components (abstract, fig. 1, C5/L53-60) comprising:
A first wall (REF 12) comprising a first outside surface (i.e. exterior surface) and a first inside surface (i.e. interior surface), the first outside surface comprising a lateral side (fig. 1);
A second wall (REF 16) comprising a second outside surface and a second inside surface (fig. 1);
Said first wall and said second wall and a portion of said bottom side defining a void space between said first inside surface of said first wall and said second outside surface of said second wall and said portion of said bottom side (i.e. space between REF 12, 16, fig. 1).
Richards (in view of Christensen) does not disclose a magnetic device disposed in said void space, said magnetic device capable of imparting an electromagnetic field upon said filter and effecting separation between the inlet and outlet (abstract). However, Kutushov discloses a magnetically driven separation system (abstract, fig. 4) where within a void space between two chambers (REF 70, 110) a magnetic separation device (REF 72, 74, C7/L1-22) is mounted, the magnetic separation device capable of imparting an electromagnetic field upon the contents of the separation system.
At the time of invention, it would have been obvious to one having ordinary skill in the art to modify the device of Richards (in view of Christensen) to include a magnetic device described in Kutoshov since such a configuration is shown to be equally effective in imparting magnetic fields to contents within a chamber and the selection of one configuration or another where each achieves the same result would be no more than obvious to one having ordinary skill in the art absent a showing of criticality or unexpected results.
Regarding claim 14, Richards (in view of Christensen) does not disclose a spiral channel disposed within the chamber and descending from the top side to the bottom side of the chamber and connected to or abutting an inside surface of said lateral side of said main body inside of said chamber, whereby the length of the flow path of fluid is greater than an outside height dimension. However, Kutushov discloses a biological separation system (abstract, fig. 3) having a spiral channel (REF 102, 204, 106) extending from an inlet to an outlet connected to an inside surface of a main body chamber (REF 100, fig. 3), the spiral shaped channel providing a channel length longer than an outside height dimension of the device (fig. 3).
At the time of invention, it would have been obvious to one having ordinary skill in the art to modify the filter of Richards to include the spirally-shaped channel as described in Kutushov in order to provide a mixing function while also allowing continuous flow of fluids within the separation system (C7/L64-C8/L13).
Regarding claim 27, Richards (in view of Christensen and Kutushov) is relied upon in the rejection of claims 1 and 13-14.
Response to Arguments
Applicant's arguments filed December 18, 2025 have been fully considered but they are not persuasive.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., a support structure integral to the separation chamber) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicant’s argument regarding the filtration material of Christensen is not found persuasive since the examiner does not rely on this feature of Christensen. As seen in the rejections set forth above, Richards discloses the filtration material, and Christensen is relied upon to disclose the feature drawn to the support structure.
In response to applicant’s argument regarding claim 26, the examiner directs applicant’s attention to the rejections set forth above in which Jessen is shown to provide a splitter comprising a surface disposed at an acute angle relative to and proximate an inlet.
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