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 .
Drawings
The drawings were objected to because: it is recommended that the second drawing page for Fig. 2g be labeled "Fig. 2g continued"; and it is recommended that the labels for figures 2a-2d, 2f, 2g (second page), 4-4i, and 5-5f read “Fig.” to be consistent with the other figure labels. Amendments to the drawings were received 6/29/2026. Accordingly, the objections to the drawings have been withdrawn.
Specification
The abstract of the disclosure was objected to because it . Amendments to the abstract were received 6/29/2026. Accordingly, the objection to the abstract has been withdrawn.
Response to Arguments
Applicant’s arguments filed 6/29/2026 have been considered but they are moot in view of a new grounds of rejection necessitated by the amendments to the claims.
Applicant argues on pp. 12 and 14 of Remarks that the instant specification adequately describes the structures of "washing arrangement"; “wash buffer providing arrangement”; “wash buffer collection arrangement”; and “buffer providing arrangement” to overcome the 112(a) rejections, 112(b) rejections, and 112(f) claim interpretation. This is not persuasive.
Applicant argues that p. 4 of the instant specification describes the washing arrangements as comprising “at least one wash buffer providing arrangement connected to a pump and to the inlet of the magnetic separator possibly via a capturing cell and a wash buffer collection arrangement connected to an outlet of the magnetic separator”. Applicant also argues that p. 5 of the instant specification describes the buffer providing arrangement as “connected to an elution cell inlet”. These are not adequate descriptions of the structures of the washing arrangement, wash buffer providing arrangement, wash buffer collection arrangement, and buffer providing arrangement themselves, but only a description of what they are connected to. A person of ordinary skill in the art could not understand what structures will perform the recited functions.
It has been held that “The inquiry is whether one of skill in the art would understand the specification itself to disclose a structure, not simply whether that person would be capable of implementing that structure.” (MPEP § 2181). One of ordinary skill in the art would not understand the structure of the washing arrangement, wash buffer providing arrangement, wash buffer collection arrangement, or buffer providing arrangement based on the description in the specification, as there is no disclosure of the actual structure of these features, only a disclosure of how a person of ordinary skill in the art may be capable of implementing some structure to accomplish the means of washing, providing wash buffer, collecting wash buffer, and providing buffer. Therefore, the instant specification does not adequately describe the structures of "washing arrangement"; “wash buffer providing arrangement”; “wash buffer collection arrangement”; and “buffer providing arrangement” to overcome the 112(a) rejections, 112(b) rejections, and 112(f) claim interpretation. Accordingly, the Examiner maintains the 112(a) rejections, 112(b) rejections, and 112(f) claim interpretation for these limitations in the claims.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
"washing arrangement" in claim 4;
“wash buffer providing arrangement” in claim 5;
“wash buffer collection arrangement” in claim 5;
“buffer providing arrangement” in claims 6 and 11;
“retaining arrangement” in claims 12 and 14-15;
“draining arrangement” in claim 18.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claims 4-6 and 11 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, 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, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 4, the claim limitation “washing arrangement” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description in the specification fails to disclose the corresponding structure, material, or acts to the function, as will be discussed in the 35 U.S.C. 112(b) section below. Therefore, the claim limitation lacks adequate written description support under 35 U.S.C. 112(a).
Regarding claim 5, the claim limitation “wash buffer providing arrangement” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description in the specification fails to disclose the corresponding structure, material, or acts to the function, as will be discussed in the 35 U.S.C. 112(b) section below. Therefore, the claim limitation lacks adequate written description support under 35 U.S.C. 112(a).
Regarding claim 5, the claim limitation “wash buffer collection arrangement” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description in the specification fails to disclose the corresponding structure, material, or acts to the function, as will be discussed in the 35 U.S.C. 112(b) section below. Therefore, the claim limitation lacks adequate written description support under 35 U.S.C. 112(a).
Regarding claims 6 and 11, the claim limitation “buffer providing arrangement” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description in the specification fails to disclose the corresponding structure, material, or acts to the function, as will be discussed in the 35 U.S.C. 112(b) section below. Therefore, the claim limitation lacks adequate written description support under 35 U.S.C. 112(a).
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1- rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitations “the rest of the feed” in line 6. There is insufficient antecedent basis for this limitation in the claim. It is recommended that “the rest of the feed” read “the feed”.
Claim 3 recites the limitation "the specific biomolecule" in line 5. There is insufficient antecedent basis for this limitation in the claim. It is recommended that “the specific biomolecule” read “the biomolecule”.
Dependent claims are rejected for the same reason as the base claim(s) upon which they depend.
Regarding claim 4, the claim limitation “washing arrangement” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The washing arrangement is only described in the written description as a washing arrangement configured for washing out other components from the magnetic separator than those magnetically bound to the parts of magnetic material (p. 4). The written description does not appear to disclose any actual structure for this device to perform the function of washing. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Regarding claim 5, the claim limitation “wash buffer providing arrangement” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The wash buffer providing arrangement is only described in the written description as a wash buffer providing arrangement connected to a pump and to the inlet of the magnetic separator (p. 4). The written description does not appear to disclose any actual structure for this device to perform the function of providing wash buffer. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Regarding claim 5, the claim limitation “wash buffer collection arrangement” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The wash buffer collection arrangement is only described in the written description as a wash buffer collection arrangement connected to an outlet of the magnetic separator (p. 4). The written description does not appear to disclose any actual structure for this device to perform the function of collecting wash buffer. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Regarding claims 6 and 11, the claim limitation “buffer providing arrangement” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The buffer providing arrangement is only described in the written description as a buffer providing arrangement connected to an elution cell inlet and a collection arrangement (p. 5). The written description does not appear to disclose any actual structure for this device to perform the function of providing buffer. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
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.
Claims 1-19 are rejected under 35 U.S.C. 103 as being unpatentable over Oscarsson et al. (US 2016/0184737 A1) (already of record) in view of Murayama et al. (US 2017/0304819 A1).
Regarding claim 1, Oscarsson et al. discloses a separation system for separating a biomolecule from a cell culture (abstract “separation of molecules… a system for performing this process”), wherein said system comprises: a magnetic separator (para. 0028 “magnetic separation device”) comprising an inlet for receiving a feed from the cell culture comprising said biomolecule and for receiving magnetic beads comprising ligands capable of binding this biomolecule (para. 0028 “flow channel… and a pump for transporting the mixture of the particles and solution containing said molecules”), said magnetic separator being configured for separating said magnetic beads with said bound biomolecule from the rest of the feed (para. 0028 “separation of molecules… magnetic particles having an affinity to said molecules to be separated”); and an elution arrangement comprising an elution cell (Fig. 5 cell culture tank/recirculation tank 1), wherein said elution arrangement is configured for eluting the biomolecule from the magnetic beads (para. 0083 “elution and regeneration of the magnetic particles”).
Oscarsson et al. does not disclose an elution cell that is distinct from the magnetic separator and configured to receive separated magnetic beads as a slurry with buffer through a dedicated connection between an outlet of the magnetic separator and the elution cell inlet. However, Murayama et al. teaches that a distinct elution container (300) configured to receive magnetic beads through a dedicated connection between an outlet and an inlet of the elution container (Fig. 1) is known in the art. Though Oscarsson et al. does not explicitly teach an elution cell distinct from the magnetic separator, it would have been obvious to a person of ordinary skill in the art to use a distinct elution container connected between an inlet and an outlet of the device because the substitution of one known element for another would have predictably resulted in a separating device that forms a flow channel through which a biomolecule is moved (abstract of Murayama et al.), with reasonable expectation. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the teachings of Oscarsson et al. with the teachings of Murayama et al. to obtain the invention as specified in claim 1.
Regarding claim 2, Oscarsson et al. discloses a separation system wherein said elution cell further comprises an elution cell outlet configured for forwarding the magnetic beads from the elution cell for reuse in the magnetic separator (Fig. 5 dotted line exiting from the bottom of tank 4 towards magnetic filter unit 2).
Regarding claim 3, Oscarsson et al. discloses a separation system further comprising: a capturing cell connected to the inlet of the magnetic separator (Fig. 5 cell culture tank/recirculation tank 1 connected to pump 7 connected to magnetic filter unit 2) and comprising a cell culture inlet for receiving a feed from a cell culture (Fig. 5 cell culture tank 13 connected to cell culture tank/recirculation tank 1) and at least one magnetic bead inlet for receiving magnetic beads (Fig. 5 vessel for recovered and optionally new magnetic particles 5), said capturing cell being configured for mixing the feed from the cell culture and the magnetic beads thus allowing the specific biomolecule to bind to the magnetic beads before forwarding it to the magnetic separator (para. 0028 “mixing said particles with a solution containing said molecules”).
Regarding claim 4, Oscarsson et al. discloses a separation system wherein the magnetic separator further comprises parts of magnetic material inside the magnetic separator which parts attract the magnetic beads when a magnetic field is applied (Fig. 5 retractable magnets 8), and said magnetic separator being configured for releasing the magnetic field when the magnetic beads are to be forwarded to the elution cell (para. 0079 “separation can be performed by both a magnetic field”), said magnetic separator further comprising a washing arrangement configured for washing out other components from the magnetic separator than those magnetically bound to the parts of magnetic material (Fig. 5 inlet for rinse water for rinsing the magnetic filter unit 11; para. 0049).
Regarding claim 5, Oscarsson et al. discloses a separation system wherein said washing arrangement comprises at least one wash buffer providing arrangement (Fig. 5 tank for wash and elution 4) connected to a pump (Fig. 5 pump 7) and to the inlet of the magnetic separator (Fig. 5 dotted line connecting bottom of tank for wash and elution 4 to pump 7 to magnetic filter unit 2) and a wash buffer collection arrangement connected to the outlet of the magnetic separator (Fig. 5 “Waste exit; Cells, broth; Cleaning solutions”), said washing arrangement being configured for flowing washing buffer through the magnetic separator for washing out other components of the feed than those bound to the magnetic parts (Fig. 5 inlet for rinse water for rinsing the magnetic filter unit 11; para. 0049).
Regarding claim 6, Oscarsson et al. discloses a separation system wherein said elution arrangement further comprises a buffer providing arrangement connected to an elution cell inlet (Fig. 5 “Inlet; Cell culture; Magnetic (P); Cleaning solutions”) and a collection arrangement connected to an elution cell outlet (Fig. 5 “Outlet; Cleaning solutions”) and wherein said elution arrangement is capable of performing elution by providing elution buffer from the buffer providing arrangement (Fig. 5 “Inlet”) and possibly also performing cleaning in place (CIP) by providing cleaning buffer from the buffer providing arrangement and collecting waste in the collection arrangement (Fig. 5 “Inlet; Cleaning solutions”) and possibly also performing equilibration of the magnetic beads in the elution cell by providing equilibration buffer from the buffer providing arrangement (Fig. 5 “Inlet”).
Oscarsson et al. does not disclose that the collection arrangement (vessel for recovered and optionally new magnetic particles 5) also collects eluate, but does disclose that the cell culture tank/recirculation tank (1) has an inlet for receiving cell culture, magnetic particles, and solutions (Fig. 5). Nonetheless, it has been held that rearrangement of parts is unpatentable because the shifting of parts would not modify the operation of the device (MPEP § 2144.04 VI). Modifying the device of Oscarsson et al. such that the vessel for recovered/new magnetic particles would also retain eluate instead of the cell culture/recirculation tank would amount to merely rearrangement of parts, as such a modification would predictably result in a vessel that mixes the magnetic particles and solution before entering the magnetic filter unit.
Regarding claim 7, the claim does not specify a further structural limitation of the subject matter claimed in claim 1, which claim 7 depends on. Furthermore, it has been held that a claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim (MPEP § 2114 II). Therefore, the apparatus disclosed by Oscarsson et al. would be fully capable of achieving every claimed intended use because the prior art apparatus is disclosed to have a tank (1) which mixes cell culture and magnetic particles before being sent to the magnetic filter tank (2) (Fig. 5; para. 0028) and would be structurally capable of providing new feed and magnetic beads to the magnetic separator while a previous portion is in the elution cell, absent clear evidence otherwise.
Regarding claim 8, the claim does not specify a further structural limitation of the subject matter claimed in claim 7, which claim 8 depends on. Furthermore, it has been held that a claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim (MPEP § 2114 II). Therefore, the apparatus disclosed by Oscarsson et al. would be fully capable of achieving every claimed intended use because the prior art apparatus is disclosed to have a tank (1) which mixes cell culture and magnetic particles before being sent to the magnetic filter tank (2) (Fig. 5; para. 0028) and would be structurally capable of providing new feed and magnetic beads to the magnetic separator while a previous portion is in the elution cell and another previous portion is in a capturing cell, absent clear evidence otherwise.
Regarding claim 9, Oscarsson et al. discloses a separation system wherein the cell culture, the magnetic separator and the elution arrangement are connected by pre-sterilized, flexible tubing and aseptic connectors (para. 0082 “requiring aseptic or even sterile environment”; para. 0088 “tubing, valves, and connectors”).
Regarding claim 10, Oscarsson et al. discloses a separation system wherein the elution cell further comprises an elution cell first outlet (Fig. 5 dotted line connecting the bottom of cell culture tank/recirculation tank 1 to pump 7 which connects to magnetic filter unit 2) for forwarding the magnetic beads for reuse in the magnetic separator and an elution cell second outlet for collecting eluate and waste in a collection arrangement (Fig. 5 “Outlet Cleaning solutions”).
Regarding claim 11, Oscarsson et al. discloses a separation system wherein the elution cell further comprises an elution cell first inlet for receiving magnetic beads from the magnetic separator (Fig. dotted line on top of cell culture tank/recirculation tank 1 connected to vessel for recovered and optionally new magnetic particles 5) and an elution cell second inlet for receiving elution buffer, cleaning in place (CIP) buffer and equilibration buffer from a buffer providing arrangement (Fig. 5 “Inlet Cell culture Magnetic (P) Cleaning solutions”).
Regarding claim 12, Oscarsson et al. discloses a separation system wherein the magnetic filter unit (2) comprises a retaining arrangement for keeping the magnetic beads within the elution cell and allowing excess buffer to escape from the elution cell (para. 0092 “the magnetic particles were completely captured on the magnets in the magnetic separator device”), but does not disclose that the retaining arrangement is located in the elution cell (cell culture tank/recirculation tank 1). Nonetheless, it has been held that rearrangement of parts is unpatentable because the shifting of parts would not modify the operation of the device (MPEP § 2144.04 VI). Modifying the device of Oscarsson et al. such that the cell culture tank/recirculation tank 1 comprises a retaining arrangement for keeping the magnetic particles within instead of the magnetic separator device would amount to merely rearrangement of parts, as such a modification would predictably result in a device which retains the magnetic particles while draining liquid from the device.
Regarding claim 13, Oscarsson et al. discloses a separation system wherein said retaining arrangement is a pinch, a magnetic force or a filter (para. 0092 “the magnetic particles were completely captured on the magnets in the magnetic separator device”).
Regarding claim 14, Oscarsson et al. discloses a separation system wherein the elution cell further comprises an adaptor for packing the magnetic beads in the elution cell (Fig. 5 drain valve 3, vessel for recovered and optionally new magnetic particles 5) and a retaining arrangement configured for keeping the magnetic beads inside the magnetic separator device while allowing buffer to escape (para. 0092 “the magnetic particles were completely captured on the magnets in the magnetic separator device”). Oscarsson et al. does not disclose that the retaining arrangement is located in the elution cell (cell culture tank/recirculation tank 1). Nonetheless, it has been held that rearrangement of parts is unpatentable because the shifting of parts would not modify the operation of the device (MPEP § 2144.04 VI). Modifying the device of Oscarsson et al. such that the cell culture tank/recirculation tank 1 comprises a retaining arrangement for keeping the magnetic particles within instead of the magnetic separator device would amount to merely rearrangement of parts, as such a modification would predictably result in a device which retains the magnetic particles while draining liquid from the device.
Regarding claim 15, the claim does not recite a further structural limitation of the subject matter claimed in claim 14, which claim 15 depends on. Furthermore, it has been held that a claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim (MPEP § 2114 II). Therefore, the apparatus disclosed by Oscarsson et al. would be fully capable of achieving every claimed intended use because the prior art apparatus is disclosed to be for recirculating magnetic particles (abstract; Fig. 5 “Recovery of magnetic particles”, vessel for recovered and optionally new magnetic particles 5) and would be structurally capable of reusing the magnetic particles absent clear evidence otherwise.
Regarding claim 16, Oscarsson et al. discloses a separation system wherein the magnetic filter unit further comprises an adaptor which is positioned at a start position in the unit (Fig. 5 retractable magnets 8).
Regarding the limitation “when a slurry of magnetic beads starts to fill the elution cell from a bottom inlet of the elution cell, said start position being closer to the bottom inlet than an end position, wherein the end position corresponds to the position of the adaptor when the filling of magnetic beads into the elution cell is completed, said adaptor keeping a force towards the flow direction of the slurry and allowing buffer to escape though the adaptor during the filling”, it has been held that a claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim (MPEP § 2114 II). Therefore, the apparatus disclosed by Oscarsson et al. would be fully capable of achieving every claimed intended use because the prior art apparatus is disclosed to capture magnetic particles on the magnets in the magnetic separator device (para. 0092) then deactivate and retract the magnets (para. 0094) and would be structurally capable of moving positions to capture magnetic beads while allowing buffer to escape, absent clear evidence otherwise.
Regarding claim 17, Oscarsson et al. discloses a separation system further comprising an intermediate cell connected to an elution cell outlet and configured for receiving the magnetic beads form the elution cell, said intermediate cell further being configured for forwarding the magnetic beads for possible reuse in the magnetic separator (Fig. 5 pump 7 connected to outlet of cell culture tank/recirculation tank 1 and magnetic filter unit 2).
Regarding claim 18, Oscarsson et al. discloses a separation system comprising a draining arrangement in the magnetic filter unit (2) for removing buffer (Fig. 5 drain valve 3), but does not disclose that the draining arrangement is in the intermediate cell (pump 7). Nonetheless, it has been held that rearrangement of parts is unpatentable because the shifting of parts would not modify the operation of the device (MPEP § 2144.04 VI). Modifying the device of Oscarsson et al. such that the drain valve is part of the pump instead of the magnetic filter unit would amount to merely rearrangement of parts, as such a modification would predictably result in a device that separates buffer from the magnetic particles and allows the magnetic particles to be recycled (Fig. 5 “Recovery of magnetic particles”, vessel for recovered and optionally new magnetic particles 5).
Regarding claim 19, Oscarsson et al. discloses a separation system wherein the draining arrangement comprises a magnet for keeping the magnetic beads inside the intermediate cell by magnetic force while draining the intermediate cell from buffer (Fig. 5 retractable magnets 8; para. 0092 “the magnetic particles were completely captured on the magnets in the magnetic separator device. The clear solution without the magnetic particles was then drained from the magnetic separator”).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHLEY LOPEZLIRA whose telephone number is (703)756-5517. The examiner can normally be reached Mon - Fri: 8:30-5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached at 571-272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ASHLEY LOPEZLIRA/Examiner, Art Unit 1799
/MICHAEL A MARCHESCHI/Supervisory Patent Examiner, Art Unit 1799
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