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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 18DEC2025 has been entered.
Response to Arguments
The Amendment filed 18DEC2025 has been entered. Applicant’s amendments have overcome each and every 112(b),112(d) rejections previously set forth in the Non-Final Office Action mailed 18SEPT2025.
Applicant's arguments filed 18DEC2025 have been fully considered but they are not persuasive.
The Applicant appears to draw a distinction between the manual operation of SORENSEN and a linear actuator operated by a controller of the claims. While SORENSEN does not teach a linear actuator, it is obvious automate a manual activity.
However, the court held that broadly providing an automatic or mechanical means (such as actuators) to replace a manual activity (of lifting or lowering parts) which accomplished the same result is not sufficient to distinguish over the prior art. In re Venner, 262 F.2d 91, 95, 120 USPQ 193, 194 (CCPA 1958). MPEP 2144.04.III.
Note that WEGENER teaches a linear actuator (par. [0100]).
Regarding the fluid pathway, whether fluid flows into and out of the container through a single inlet/outlet pipe or a separate inlet pipe and a separate outlet pipe, it achieves the same result of flowing fluid into and out of the device and does not appear to be inventive. Such engineering design choices are known in the art.
Note that WEGENER teaches a single fluid pathway (Fig. 11).
See below for rejections comprising the combination of SORENSEN and WEGENER. Such combinations are obvious for the stated reasons. For example, as explained above, automating a manual activity using a linear actuator is known in the art and would be obvious to employ as such in the method of SORENSEN. There is nothing teaching away from this in either reference. Note that a rejection of SORENSEN in view of WEGENER starts with SORENSEN as the primary reference and modified by features, limitations, and methods as taught or suggested by WEGENER as outlined and explained in the rejection. Both references have magnetic selectors that may be opened and closed such that a bag may be subjected to magnetic selection and thus are combinable.
The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
Regarding a uniform surface of the door, SORENSEN teaches the door has a uniform facing door surface (Fig. 3b #9; see Figs. 3b and 3c showing a flat, uniform set distance of 2mm to accommodate the bag; C2/L6-14). The bar #14 is an additional element used to increase the flow path length in the bag (Fig. 3a).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 1-7,9-17,19-23 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, at the time the application was filed, had possession of the claimed invention.
Regarding claims 1,11, the specification as originally filed does not describe “the magnet carrier being continuously exposed to the floor throughout the method”.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 1-7,9-17,19-23 rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Regarding claim 1, the claim limitation “the magnet carrier being continuously exposed to the floor” is not understood as no explanation is provided.
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.
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.
Claim(s) 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over SORENSEN (US 4910148) in view of WEGENER (US 20170315121).
Regarding claims 1,11, SORENSEN teaches magnetic separation of magnetized particles from biological fluids (title, Figs.) including a method of operating a biological fluid (abstract) separation system incorporating a magnetic selector comprising:
a housing (cassette, Fig. 1 #K) including a floor (Fig. 1 #15) having a floor surface of the selector;
a magnet carrier (Fig. 1 #MP) disposed on an opposite side of the floor from the floor surface and having e.g. a magnet (Fig. 1 #M) disposed thereon;
the magnet carrier being moveable relative to the floor between:
a first state (e.g. any of 10-100% magnetic intensity; Fig. 2 #25; C4/L48-49) wherein the magnet carrier is adjacent the floor, and
a second state wherein the magnet carrier is spaced from the floor (e.g. 0% magnetic intensity; Fig. 2 #25);
wherein the housing of the magnetic selector further comprises a door (Fig. 3b #9) moveable relative to the floor between an open state (Fig. 3b) and a closed state (Fig. 3c), the door having a uniform facing door surface (Fig. 3b #9; see Figs. 3b and 3c showing a flat, uniform set distance of 2mm to accommodate the bag; C2/L6-14) being a distance apart from the floor surface (the distance such that the container fits into the device) in the closed state (Fig. 3c) and defining a space therebetween,
the method comprising:
disposing a container connected to a fluid pathway (see hoses e.g. Fig. 3a #4-5; C2/L61-62) on the floor surface (Fig. 1 #BP; C4/L36-38);
moving the door from the open state (so as to allow disposing of the container into the device; Fig. 3b) to the closed state (so as to allow magnetic separation within the container; Fig. 3c);
adding a fluid having magnetic particles to a fluid in the container so as to form a complex with target cells in the fluid (abstract; Example);
moving the magnet carrier to the first state to apply a magnetic field to a fluid in the container (C4/L48-49); and,
moving the door to the open state (obviously the door has to be opened in order to remove the container);
removing the container (C4/L67-68).
Note that use of the apparatus will inherently anticipate the method under normal operation, see MPEP 2112.02.
SORENSEN is silent (not explicit) as to moving the magnet carrier to the second state (e.g. 0% magnetic intensity) from the first state to disengage the magnetic field from the container; however, one having ordinary skill in the art would recognize that such a step may be necessary when the magnetic field is not needed such as during an incubation step or resetting the device when the separation step is finished (see also “0” marker/groove in Fig. 2).
In considering the disclosure of SORENSEN, it is proper to take into account not only specific teachings of the reference but also the inferences which one skilled in the art would reasonably be expected to draw therefrom (MPEP 2144.01).
SORENSEN does not teach a linear actuator or one fluid pathway. However, WEGENER teaches a method for selecting and culturing cells (title, Figs) including a method of operating a biological fluid separation system (abstract) incorporating a magnetic selector (Figs. 11,13 #900), the magnetic selector comprising:
a housing (e.g. Fig. 13 #906,918);
a magnet carrier (e.g. Fig. 13 #904) and having a magnet disposed thereon (par. [0099]); and,
a linear actuator (Fig. 13 #916) operated by a controller (Fig. 12 #700; par. [0098]), with the linear actuator being programmed to move the magnet carrier directly vertically between a first state wherein the magnet carrier is close to a door (Fig. 13 #902) and a second state wherein the magnet carrier is spaced from the door (par. [00100]);
wherein the door is moveable between an open state and a closed state (par. [0100]), the door having a uniform facing door surface (two flat parallel plates having a uniform distance therebetween) being a distance apart from the magnetic carrier in the closed state and defining a space therebetween (note that either plate or both plates may be moved between the open state and closed state; par. [0100]), the method comprising:
disposing a container (Fig. 11 #150; par. [0098]) on the magnetic carrier surface;
wherein the container is configured for transfer of all fluids into and out of the container through one fluid pathway during operation of the magnetic selector (see flow line connecting bidirectional pump #206 to the magnetic selector #900 of Fig. 11);
moving the door from the open state to the closed state (par. [0111]);
moving the magnet carrier to the first state to apply a magnetic field to a fluid in the container (par. [0111]);
moving the magnet carrier to the second state from the first state to disengage the magnetic field from the container (par. [0111]);
moving the door to the open state (par. [0111]); and
removing the container (par. [0111]).
WEGENER teaches that either a linear actuator or other manual means may be utilized to move the plates open and closed (par. [0100]). Note that the court held that broadly providing an automatic or mechanical means (such as actuators) to replace a manual activity (of lifting or lowering parts) which accomplished the same result is not sufficient to distinguish over the prior art. In re Venner, 262 F.2d 91, 95, 120 USPQ 193, 194 (CCPA 1958). MPEP 2144.04.III.
Regarding the fluid pathway, whether fluid flows into and out of the container through a single inlet/outlet pipe as taught by WEGENER or a separate inlet pipe and a separate outlet pipe as taught by SORENSEN, it achieves the same result of flowing fluid into and out of the device. Such engineering design choices are known in the art and would be obvious absent persuasive evidence that a new and unobvious result is produced.
Therefore, before the effective filing date of the invention, it would have been obvious to one of ordinary skill in the art to modify the method of SORENSEN to automate a manual means for moving the magnetic carrier with an automated linear actuator as is known in the art. The references are combinable, because they are in the same technological environment of separations. See MPEP 2141 III (A) and (G).
Regarding claims 2,13, SORENSEN teaches agitating the fluid in the container while the container is disposed on the floor surface (C4/L36-38).
Regarding claims 3,14, SORENSEN implies agitating the fluid in the container after moving the magnet carrier to the second state (the agitation step is without magnetic separation; C4/L36-38; 44-46).
In considering the disclosure of SORENSEN, it is proper to take into account not only specific teachings of the reference but also the inferences which one skilled in the art would reasonably be expected to draw therefrom (MPEP 2144.01).
Regarding claim 7, SORENSEN teaches adding a magnetic particle to the fluid in the container (C4/L32-33) prior to moving the magnet carrier to the first state to apply a magnetic field (C4/L48-49) to the fluid in the container;
the magnetic particle forming a complex with a target cell in the fluid (C4/L34-35).
Regarding claim 9-10,19, SORENSEN teaches the container is e.g. flexible (“plastic bag”, C2/L8; and clearly shown in Fig. 3a) and conforms to the space between the floor surface and the facing door surface when the door is in the closed state (Figs. 3a-3c; clearly a compressed plastic bag will conform to the device; C2/L6-14).
Regarding claims 4,6,12,15, SORENSEN teaches:
incubating the fluid (C4/L36) in the container after adding the fluid having magnetic particles (C4/L32-33);
moving the magnet carrier to the first state to apply a magnetic field to the fluid in the container after agitating the fluid in the container (C4/L36-51);
moving the magnet carrier to the second state from the first state to disengage the magnetic field from the container (implied when the magnetic field is no longer required; Example); and,
removing a portion of the fluid (“discharge”; C4/L52-59).
SORENSEN does not teach adding a diluent or incubating after moving the magnet carrier to the first state. However, WEGENER teaches a method for selecting and culturing cells (title, Figs) including a method of operating a biological fluid separation system (abstract) incorporating a magnetic selector (Figs. 11,13 #900), the method comprising:
disposing a container (par. [0098]);
adding a fluid having magnetic particles to a fluid in the container so as to form a complex with target cells in the fluid (par. [0004]);
using a magnet to apply a magnetic field to the fluid in the container (Fig. 10);
and adding diluent to the container after moving the magnet carrier to the second state (Fig. 10 #538; par. [0093]) and removing a portion of fluid and diluent (Fig. 10, steps #532; par. [0092]); and,
incubating (Fig. 10 #540) the fluid in the container after adding the fluid having magnetic particles and moving the magnet carrier to the first state.
WEGENER teaches that adding a diluent may be in preparation of a post-separation incubation step for growth of the desired cells (par. [0093]).
Therefore, at the time the invention was filed, it would have been obvious to one of ordinary skill in the art to combine the method of SORENSEN with a step of adding a diluent and incubating after activating the magnet of WEGENER in order to dilute the concentration of cells for growth of the desired cells with incubation. The references are combinable, because they are in the same technological environment of magnetic separations. See MPEP 2141 III (A) and (G).
Regarding claims 5,16-17, SORENSEN teaches:
moving the magnet carrier to the first state to apply a magnetic field to the fluid in the container (C4/L47-51);
removing a portion of the fluid and/or removing the negative fraction unbound cells from the container (“discharge”; C4/L47-59; C1/L19-20); and,
moving the magnet carrier to the second state from the first state to disengage the magnetic field from the container (implied when the magnetic field is no longer required; Example).
SORENSEN does not teach adding a diluent. However, WEGENER teaches a method for selecting and culturing cells (title, Figs) including a method of operating a biological fluid separation system (abstract) incorporating a magnetic selector (Figs. 11,13 #900), the method comprising:
disposing a container (par. [0098]);
adding a fluid having magnetic particles to a fluid in the container so as to form a complex with target cells in the fluid (par. [0004]);
using a magnet to apply a magnetic field to the fluid in the container (Fig. 10); and,
moving the magnet carrier to the first state to apply a magnetic field to the fluid in the container after adding the diluent to the container (Fig. 10, steps #514,530); and removing a portion of the fluid and diluent from the container (Fig. 10, steps #532).
WEGENER teaches that adding a diluent may be made in order to remove platelets and plasma in preparation of associating the conjugated antibody beads with the target cells (par. [0083-0084]). The magnet may be activated of course to remove material not held in place by the magnet (par. [0092]).
Therefore, at the time the invention was filed, it would have been obvious to one of ordinary skill in the art to combine the method of SORENSEN with a step of apply a magnetic field to the fluid after adding a diluent and removing fluid and diluent of WEGENER in order to remove platelets and plasma and remove materials not held by the magnet for purification. The references are combinable, because they are in the same technological environment of magnetic separations. See MPEP 2141 III (A) and (G).
Regarding claim 20, SORENSEN teaches a pump (C4/L57) on a fluid processor configured to transfer into and out of the container.
SORENSEN is silent as to a controller. However, WEGENER teaches a method for selecting and culturing cells (title, Figs) including a method of operating a biological fluid separation system (abstract) incorporating a magnetic selector (Figs. 11,13 #900) and a controller coupled to a fluid processor, the magnetic selector, and a pump (abstract; Fig. 12; par. [0104]).
WEGENER teaches the process is automated by the controller (par. [0026,0045]).
Therefore, at the time the invention was filed, it would have been obvious to one of ordinary skill in the art to combine the method of SORENSEN with a controller of WEGENER in order to easily control and automate the purification process. The references are combinable, because they are in the same technological environment of magnetic separations. See MPEP 2141 III (A) and (G).
Claim(s) 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over WEGENER (US 20170315121) in view of SORENSEN (US 4910148).
Regarding claim 21, WEGENER teaches a method for selecting and culturing cells (title, Figs.) including a method of operating a fluid processing system comprising:
a fluid processor (par. [0026],[0097-0098]; Fig. 11 #200) that operates on a disposable fluid circuit (Fig. 11 #100) that is connectable to a source container (e.g. Fig. 11 #102; par. [0108]) filled with a biological fluid and configured to separate the biological fluid from the source container into at least two volumes of material (par. [0026]);
a container (Fig. 11 #150) configured to be a selection container received by a magnetic selector (Figs. 11-13 #900) and being connected to the fluid processor along a fluid pathway (par. [0028]);
the magnetic selector (Figs. 11-13 #900) comprising:
a housing (e.g. Fig. 13 #906,918) configured to receive the container (Fig. 11 #150; par. [0098]);
a magnet carrier (e.g. Fig. 13 #904) and having a magnet disposed thereon (par. [0099]); and,
a linear actuator (Fig. 13 #916) operated by a controller (Fig. 12 #700; par. [0098]), with the linear actuator being programmed to move the magnet carrier directly vertically;
wherein the housing of the magnetic selector further comprises a door (Fig. 13 #902) moveable relative to the floor between an open state and a closed state;
the door having a facing door surface being spaced a uniform distance apart from the magnetic carrier in the closed state and defining a selected spacing therebetween (the plates #902,904 are parallel and movable relative to each other and have a selected spacing for the container #150; par. [0098,0100]; Fig. 13);
the method comprising:
pre-processing, processing, and post-processing states (use of the apparatus will inherently anticipate the method under normal operation, see MPEP 2112.02);
the pre-processing state further comprising:
selection of a procedure protocol, procedure setup (or parameters; par. [0045,0107]);
installation of the disposable fluid circuit on the fluid processor (par, [0052,0107]); and
attaching the source container and a solution container to the fluid processor (par, [0052,0107]) and moving the door from the open state to the closed (par. [0100,0111]);
the processing state further comprising:
introduction of the biologic fluid in the source container to the disposable fluid circuit (par. [0108]);
washing (rinse), harvesting (reduction) and dilution of the of the biologic fluid (par. [0108,0115-0116]; Fig. 14);
incubation with magnetic particles to perform negative selection incubation (Fig. 14 #820,830; par. [0117],[0121],[0125]);
moving the magnet carrier between a first closed state to subject the container to a magnetic field (Fig. 16) and a second open state to remove the magnetic field (Fig. 15); and
removal of negative fraction comprising unbound cells that remain in suspension in the container (par. [0125]);
the post-processing state further comprising:
sealing the container, moving the door to the open state (clearly the plates #902,904 are separated in order to allow removal of the container) and removing the final product (par. [0111]); and
removing the disposable fluid circuit (it’s disposable, after all).
In considering the disclosure of WEGENER, it is proper to take into account not only specific teachings of the reference but also the inferences which one skilled in the art would reasonably be expected to draw therefrom (MPEP 2144.01).
WEGENER is sparse as to the details of the magnet carrier of the magnetic selector. However, SORENSEN teaches magnetic separation of magnetized particles from biological fluids (title, Figs.) including a method of operating a biological fluid (abstract) separation system incorporating a magnetic selector comprising:
a housing (cassette, Fig. 1 #K) including a floor (Fig. 1 #15) having a floor surface of the selector;
a magnet carrier (Fig. 1 #MP) disposed on an opposite side of the floor from the floor surface and having e.g. a magnet (Fig. 1 #M) disposed thereon;
the magnet carrier being moveable relative to the floor between:
a first state (e.g. any of 10-100% magnetic intensity; Fig. 2 #25; C4/L48-49) wherein the magnet carrier is adjacent the floor, and
a second state wherein the magnet carrier is spaced from the floor (e.g. 0% magnetic intensity; Fig. 2 #25).
SORENSEN teaches the magnetic selector permits sterile, rapid, efficient, and clean separation of cells and allows for the enclosure to operate independently of the magnetic carrier (C1/L32-36).
Therefore, at the time the invention was filed, it would have been obvious to one of ordinary skill in the art to modify the magnetic selector of WEGENER with a magnet carrier disposed opposite the floor as taught by SORENSEN in order to provide an independently operated, sterile, rapid, efficient and clean separation. The references are combinable, because they are in the same technological environment of magnetic separations. See MPEP 2141 III (A) and (G).
Regarding claim 22, WEGENER does not teach a positive selection. However, SORENSEN teaches that such separation techniques may use positive separation and/or negative separation while the magnet is active (C1/L16-20). It is obvious to one having ordinary skill in the art that the choice of positive separation and/or negative separation may be made as an obvious engineering design choice to provide the desired protocol for separation.
It is obvious to one having ordinary skill in the art to try positive separation and/or negative separation by choosing from a finite number of identified, predictable solutions (positive, negative, or in combination) with a reasonable expectation of success by reaching a workable as desired in order to successfully separate the desired and/or undesired fraction. See MPEP 2143.I.(E).
Regarding claim 23, WEGENER teaches the fluid processor further comprises hardware and a controller (abstract; par. [0004]) configured to operate the hardware while the disposable fluid circuit is installed on the hardware and is connected to the source container and the container disposed on the floor of the magnetic selector (par. [0056],[0104]).
Telephonic Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LIAM A ROYCE whose telephone number is (571)270-0352. The examiner can normally be reached M-F ~08:00~15:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Lebron can be reached at (571)272-0475. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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LIAM A. ROYCE
Primary Examiner
Art Unit 1777
/Liam Royce/ Primary Examiner, Art Unit 1777