Prosecution Insights
Last updated: May 04, 2026
Application No. 18/317,411

Method and System for Separating Biomolecules

Non-Final OA §102§103§112
Filed
May 15, 2023
Priority
Dec 28, 2016 — GB 1622304.2 +4 more
Examiner
LOPEZLIRA, ASHLEY NICOLE
Art Unit
1799
Tech Center
1700 — Chemical & Materials Engineering
Assignee
CYTIVA SWEDEN AB
OA Round
1 (Non-Final)
64%
Grant Probability
Moderate
1-2
OA Rounds
9m
Est. Remaining
99%
With Interview

Examiner Intelligence

Grants 64% of resolved cases
64%
Career Allowance Rate
21 granted / 33 resolved
-1.4% vs TC avg
Strong +48% interview lift
Without
With
+48.0%
Interview Lift
resolved cases with interview
Typical timeline
3y 9m
Avg Prosecution
33 currently pending
Career history
66
Total Applications
across all art units

Statute-Specific Performance

§101
1.0%
-39.0% vs TC avg
§103
45.9%
+5.9% vs TC avg
§102
23.4%
-16.6% vs TC avg
§112
26.2%
-13.8% vs TC avg
Black line = Tech Center average estimate • Based on career data from 33 resolved cases

Office Action

§102 §103 §112
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. Election/Restrictions Applicant's election with traverse of FILLIN "Enter claim indentification information" \* MERGEFORMAT Group I, claims 1-19, in the reply filed on FILLIN "Enter mail date of the reply." \* MERGEFORMAT 2/13/2026 is acknowledged. The traversal is on the ground(s) that FILLIN "Enter claim indentification information" \* MERGEFORMAT a search relating to the claimed invention of one group will identify any references that are material to the claimed invention of the other group and a search for both claim groups would not pose an undue burden . This is not found persuasive because G roup I is drawn to a separation system with a positively recited structure of an elution cell inlet for receiving separated magnetic beads whereas Group I I is directed to a n elution arrangement with a positively recited structure of an elution cell inlet for receiving magnetic beads , and therefore the search queries for each group would be different as Group I I does not necessarily require separated magnetic beads as a positively recited element. Therefore, the examiner maintains that a serious search burden is present. The requirement is still deemed proper and is therefore made FINAL. Priority Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Information Disclosure Statement The information disclosure statement (IDS) submitted on 5/15/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. Drawings The drawings are 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 . Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance. Specification Applicant is reminded of the proper language and format for an abstract of the disclosure. The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details. The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided. The abstract of the disclosure is objected to because FILLIN "Enter appropriate information" \* MERGEFORMAT it is less than 50 words in length . A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b). Claim Objections Claim 4 is objected to because of the following informalities: I t is recommended that "which parts attract" in lines 2-3 read "which attract" . Appropriate correction is required. Claim 6 is objected to because of the following informalities: FILLIN "Enter appropriate explanation" \* MERGEFORMAT I t is recommended that "collect waste" in line 7 read " collecting waste" . Appropriate correction is required. I t is recommended that "possible" in line 7 read "possibly "; and it is recommended that "cleaning in place , CIP, " in line 6 read "cleaning in place (CIP) " . Appropriate correction is required. Claim 8 is objected to because of the following informalities: I t is recommended that " one previous portion is in a capturing cell" in line 3 read " another previous portion is in a capturing cell" . Appropriate correction is required. Claim 9 is objected to because of the following informalities: "aseptic connectors, closed system" is taken to mean "aseptic connectors in a closed system" . Appropriate correction is required. Claim 11 is objected to because of the following informalities: I t is recommended that "cleaning in place , CIP, " in line 3 read "cleaning in place (CIP) " . Appropriate correction is required. Claim 13 is objected to because of the following informalities: I t is recommended that "The separation system according to claim 13 " read "The separation system according to claim 12 " . Appropriate correction is required. For the purpose of examination on the merits, the Examiner is interpreting claim 13 as if dependent on claim 12 which provides antecedent basis for a retaining arrangement . Claim FILLIN "Enter claim indentification information" \* MERGEFORMAT 16 is objected to because of the following informalities: FILLIN "Enter appropriate explanation" \* MERGEFORMAT I t is believed that "positon" in line 2 should read "position " . Appropriate correction is required. I t is recommended that " which end position" in line 4 read " wherein the end position " . Appropriate correction is required. 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: FILLIN "Identify each claim limitation." \d "[ 1 ]" " washing arrangement " in claim FILLIN "Indicate the claim(s) in which each respective limitation appears." \d "[ 2 ]" 4 ; “wash buffer providing arrangement” in claim 5; “wash buffer collection arrangement” in claim 5 ; “buffer providing arrangement” in claim s 6 and 11; “retaining arrangement” in claim s 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. Claim FILLIN "Enter claim identification information" \* MERGEFORMAT s 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 appl icant regards as his invention. Claim FILLIN "Enter claim indentification information" \* MERGEFORMAT s 1-20 are 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 FILLIN "Enter claim identification information" \* MERGEFORMAT 1 recites the limitation s " FILLIN "Enter appropriate information" \* MERGEFORMAT said bound biomolecule " in FILLIN "Enter appropriate information" \* MERGEFORMAT line 6 and “the rest of the feed” in line 6 . There is insufficient antecedent basis for these limitation s in the claim. It is unclear whether the “bound biomolecule” is the same biomolecule that is capable of binding to the ligands on the magnetic beads, or another biomolecule. Claim 1 also recites the limitation “the magnetic beads” in line 10. It is unclear whether the “magnetic beads” are the “separated magnetic beads” recited in line 9, or other magnetic beads. Claim 3 recites the limitation " the specific biomolecule " in line 5 . There is insufficient antecedent basis for this limitation in the claim. Claim 5 recites the limitation “possibly” in line 3. It is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Claim 6 recites the limitation “possibly” in line 5 and “possible” in line 7 . It is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Claim 7 is directed to an apparatus, but contains method step limitations: “wherein a new portion of feed from the cell culture and magnetic beads are provided into the magnetic separator while a previous portion is in the elution cell, whereby at least two portions of magnetic beads are circulating in the separation system”. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite (MPEP § 2173.05(p)). Claim 8 is directed to an apparatus, but contains method step limitations: “ wherein a new portion of feed from the cell culture and magnetic beads are provided into the magnetic separator while one previous portion is in the elution cell and one previous portion is in a capturing cell, whereby three portions of magnetic beads are circulating in the separation system ”. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite (MPEP § 2173.05(p)). Dependent claims are rejected for the same reason as the base claim(s) upon which they depend. Regarding claim 4, the claim limitation “ FILLIN "Recite the limitation that invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph." \d "[ 1 ]" 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 “ FILLIN "Recite the limitation that invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph." \d "[ 1 ]" 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 “ FILLIN "Recite the limitation that invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph." \d "[ 1 ]" 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 “ FILLIN "Recite the limitation that invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph." \d "[ 1 ]" 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 § 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. Claims FILLIN "Insert the claim numbers which are under rejection." \d "[ 1 ]" 1- 5 , 7-11, and 17 are rejected under 35 U.S.C. 102 FILLIN "Insert either \“(a)(1)\” or \“(a)(2)\” or both. If paragraph (a)(2) of 35 U.S.C. 102 is applicable, use form paragraph 7.15.01.aia, 7.15.02.aia or 7.15.03.aia where applicable." \d "[ 2 ]" (a)(1) as being FILLIN "Insert either—clearly anticipated—or—anticipated—with an explanation at the end of the paragraph." \d "[ 3 ]" anticipated by FILLIN "Insert the prior art relied upon." \d "[ 4 ]" Oscarsson et al. (US 2016/0184737 A1) (already of record) . 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 ) , said elution cell comprising an elution cell inlet in connection with an outlet from the magnetic separator (Fig. 5 dotted line on top of tank 1 connecting magnetic filter unit 2 to the tank 1 ) for receiving said separated magnetic beads as a slurry with buffer from the magnetic separator, wherein said elution arrangement is configured for eluting the biomolecule from the magnetic beads (para. 0083 “elution and regeneration of the magnetic particles”) . 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 7, the claim does not specify a further structural limitation of the subject matter claimed in claim 1, which claim 7 depends on. Furthermore, i t 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, i t 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 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) . 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. Claim s FILLIN "Insert the claim numbers which are under rejection." \d "[ 1 ]" 6, 1 2-16 and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over FILLIN "Insert the prior art relied upon." \d "[ 2 ]" Oscarsson et al. (US 2016/0184737 A1) (already of record) . 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 collect 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 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, i t 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, which 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”, i t 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 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 ”) . Citation of Pertinent Prior Art The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Florescu (WO 2011/059512 A1) (already of record) discloses a device for filtering blood and attaching analytes within the blood to magnetic particles. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT ASHLEY LOPEZLIRA whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (703)756-5517 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT 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, FILLIN "SPE Name?" \* MERGEFORMAT Michael Marcheschi can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT 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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Prosecution Timeline

May 15, 2023
Application Filed
Apr 01, 2026
Non-Final Rejection — §102, §103, §112 (current)

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

1-2
Expected OA Rounds
64%
Grant Probability
99%
With Interview (+48.0%)
3y 9m (~9m remaining)
Median Time to Grant
Low
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