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 Group I, claims 1-9, 21, and 22, in the reply filed on February 10, 2026 is acknowledged. The traversal is on the ground(s) that the technical features shared between the alleged inventions are special technical features. This is not found persuasive because the instant application is a national stage entry filed under 35 U.S.C. 371 and is subject to lack of unity practice, see MPEP 1893.03(d). It is noted that inventions listed as Groups I and II do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features as set forth on pages 4-5 of the previous Office Action, specifically that the special technical feature is a stopcock manifold and a cell processing device, which was subsequently taught by Griffin et al (WO 2019/106207 A1).
The requirement is still deemed proper and is therefore made FINAL.
Claims 10-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on February 10, 2026.
Drawings
The drawings were received on 5/25/203. These drawings are acceptable.
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.
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 1-9 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 1 recites the limitation "the cell processing device" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim. Claims 2-9 are ultimately dependent upon claim 1, and thus, inherit the same deficiencies.
Claim 7 recites each of “a stopcock manifold interface of the cell processing device” and “a stopcock manifold interface of the magnetic cell isolation device.” These limitations are indefinite because it is not clear if the recited stopcock manifold interface(s) is intended to be two separate interfaces associated with each of the cell processing device and the magnetic cell isolation device, or if it is a single stopcock manifold interface. In the event that is intended to be two separated stopcock manifold interfaces, applicant should consider the incorporation of language that indicates a first stopcock manifold interface and a second stopcock manifold interface. If the recited stopcock manifold interface is intended to a be a single stopcock manifold interface, applicant should consider the incorporation of a “the stopcock manifold interface” in line 4. Clarification is requested.
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.
Claim(s) 21 and 22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Griffin et al (WO 2019/106207 A1) (provided by applicant in IDS dated 5/12/2026).
With respect to claim 21 Griffin discloses a method for isolating target cells, comprising the steps of:
incubating a cell population with magnetic particles to form a cell mixture containing bead-bound target cells (See Para. 0250-0251 for discussion of incubating magnetic isolation beads and enriched cells);
generating a magnetic field (See Para. 0251 for discussion of isolating the bead bound cells using magnetic field plates 964,966); and
passing the cell mixture through a flow path within the magnetic field a plurality of times to retain the bead-bound target cells in an area of the flow path within the magnetic field (See Paras. 0253-0257).
With respect to claim 22 Griffin discloses that passing the cell mixture through a flow path within the magnetic field a plurality of times includes:
Passing the cell mixture from a first bag, through the flow path, and to a second bag (See Para. 0257 for discussion of how content of the process bag 932 may be transferred to the second storage bag 940); and
Passing the cell mixture from the second bag, through the flow path, and to the first bag (See Para. 0257-0267 for discussion of how the second storage bag 940 is agitated, and then the contents of the second storage bag 940 are then transferred back to the process bag; also discussion of processes that may take place that involve circulating the bead bound cells to various bags within the process loop 1110).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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) 1-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Griffin et al (WO 2019/106207 A1) (provided by applicant in IDS dated 5/12/2026).
With respect to claim 1 Griffin discloses a kit (apparatus 900, See Para. 0247) for magnetic cell isolation comprising:
a first stopcock manifold (stopcock manifold 918, See Para. 0247) having at least four stopcocks (See Fig. 80 for depiction of 4 stopcocks),
a separation chamber (centrifugal processing chamber 912, See Para. 0247) configured for use with a centrifugal processing chamber of the cell processing device, the separation chamber in fluid communication with the first stopcock manifold (See Fig. 80);
a mixing bag (second storage bag 940, See Para. 0257) configured for use with a heating/cooling mixing chamber of a cell processing device, the mixing bag in fluid communication with the first stopcock manifold (See Para. 0247 and 0257);
a magnetic cell isolation holder (magnetic cell isolation holder 960, See Para. 0249), the magnetic cell isolation holder configured for use with a magnetic field generator of a magnetic cell isolation device; and
a plurality of cell processing bags in fluid communication with the first and/or second stopcock manifolds (See Para. 0249 and Figs. 78 and 80 for depiction and discussion of bags that may include a sample source bag 930, a process bag 932, an isolation buffer bag 934, a washing bag 936, a first storage bag 938, a post-isolation waste bag 942, a washing waste bag 944, a media bag 946, a release bag 948 and a collection bag 950).
Applicant should note the italicized limitations are directed to the function of the apparatus and/or the manner of operating the apparatus. All the structural limitations of the claim have been disclosed by Griffin and the apparatus of Griffin is capable of the recitation of claim 1. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Griffin (see MPEP §2114).
Griffin fails to disclose a second stopcock manifold having at least four stopcocks, the second stopcock manifold in fluid communication with the first stopcock manifold, and that the magnetic cell isolation holder in fluid communication with the second stopcock manifold. However, the courts have held In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960) that even if a reference does not teach a plurality of a feature, a mere duplication of parts has no patentable significance unless a new and unexpected result is produced. As such, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the first stopcock manifold in fluid communication with the second stopcock manifold, and the magnetic cell isolation holder in fluid communication with the second stopcock manifold such that the connections within the system can be varied depending upon the use of the system.
With respect to claim 2 Griffin depicts that the mixing bag is a 3D mixing bag (See Fig. 78 for depiction of the storage bag 240 being a three-dimensional bag).
With respect to claim 3, modified Griffin teaches the incorporation of a peristaltic pump connected to the first stopcock manifold (peristaltic pump tubing/assembly 914; Para. 0253 describes the process loop in part as the peristaltic pump tubing being connected to the stopcock manifold 918). As such, it would have been obvious to one of ordinary skill in the art before the effective filing date to make the first stopcock manifold connectable to the second stopcock manifold via the peristaltic pump tubing such that the connections within the system can be varied depending upon the use of the system.
With respect to claim 4 modified Griffin teaches a collection bag (process bag 932) that is in fluid communication with the stopcock manifold 918 (See Para. 0250-0251). As such, it would have been obvious to one of ordinary skill in the art before the effective filing date to make the process bag connectable with the second stopcock manifold via such that the connections within the system can be varied depending upon the use of the system.
With respect to claim 5 modified Griffin teaches that the magnetic cell isolation holder includes a magnetic retention element (magnetic retention element of material 968, See Para. 0249).
With respect to claim 6 it should be noted that the magnetic cell isolation device and the magnetic field generator have not been positively recited as claimed embodiments of the recited kit. As such, the recited functionality of the magnetic cell isolation holder being insertable into a slot is directed to the function of the apparatus and/or the manner of operating the apparatus. All the positively recited structural limitations of the claim have been disclosed by Griffin and the apparatus of Griffin is capable of the recitation of claim 6. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Griffin (see MPEP §2114).
With respect to claim 7 it should be noted that the stopcock manifold interface, the cell processing device, and the magnetic cell isolation device have not been positively recited as claimed embodiments of the recited kit. As such, the recited functionality of the first and second stopcock manifolds being configured to be received on stopcock manifold interfaces of the cell processing device and magnetic cell isolation devices, respectively, is directed to the function of the apparatus and/or the manner of operating the apparatus. All the positively recited structural limitations of the claim have been disclosed by Griffin and the apparatus of Griffin is capable of the recitation of claim 7. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Griffin (see MPEP §2114).
Allowable Subject Matter
Claims 8 and 9 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The closest cited prior art of reference fails to disclose or teach the incorporation of a blister pack that encloses the first stopcock manifold, the mixing bag, the second stopcock manifold, the magnetic cell isolation holder, and the plurality of cell processing bags (claim 8). Griffin does not disclose that the recited components are intended to be maintained together within a separate storage means. Claim 9 is dependent upon claim 8, and thus, inherits the same status.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRITTANY I FISHER whose telephone number is (469)295-9182. The examiner can normally be reached IFP.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James Lin can be reached at (571) 272-8902. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRITTANY I FISHER/Examiner, Art Unit 1796 May 27, 2026
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