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/Restriction
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, claim(s) 1-5, drawn to a system for generating a product enriched in one or more target particles.
Group II, claim(s) 6-28, drawn to a system for generating a product with a plurality of pumps.
Group III, claim(s) 29-33, drawn to a system for generating that includes a cartridge with one or more sensors.
Group IV, claim(s) 34-38, drawn to a system for generating a produce with at least one degassing unit.
Group V, claim(s) 39-49, drawn to a system for generating a product that includes a plurality of input containers.
Group VI, claim(s) 50-53, drawn to a system for generating a product where the cartridges are releasably coupled and supported.
Group VII, claim(s) 54-77, drawn to a method for operating a cassette.
Group VIII, claim(s) 78-94, drawn to a method for displaying a GUI on a computer.
The groups of inventions listed above 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 for the following reasons:
Groups I-VIII lack unity of invention because even though the inventions of these groups require the technical feature of the cassette with microfluidic cartridges with an input, output and recirculation channel, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Kahati et al. (WO 2010/025302 A1 – hereafter ‘302). ‘302 discloses a bioprocessing device (device 400; Fig. 4, i.e. the cassette) that has slots (slot 412; Fig. 4) for receiving a cartridge (cartridge 414; Fig. 4) that recirculates reagents within the cartridge ([0011]). These cartridges include systems for nucleic acid separation, purification and collection ([0015]). The system also includes a plurality of sensors that can be operated by software within a computer system ([0084]) along with a plurality of valves ([00164]). Therefore, the distinct inventions have lack of unity.
During a telephone conversation with Tatsuya Sawada on 03/12/2026 a provisional election was made without traverse to prosecute the invention of Group II, claims 6-28. Affirmation of this election must be made by applicant in replying to this Office action. Claims 1-5 and 29-94 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/06/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
The information disclosure statement (IDS) submitted on 10/07/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 6-28 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 6 recites the limitation "the one or more microfluidic cartridges" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 6 recites the limitation "the sample" in line 7. There is insufficient antecedent basis for this limitation in the claim.
Claims 7-28 are rejected under 35 U.S.C. 112b since the claims incorporate and depend upon all the limitations of claim 6.
Appropriate corrective action is required.
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 6-16, 19, 20 and 23-28 are rejected under 35 U.S.C. 102a1 as being anticipated by Hirshel et al. (US 2015/0225685 A1 – hereafter ‘685).
It should be noted that for some limitations that the exact citations are from WO 2007/139742 which is incorporated by reference within ‘685 and therefore all discussions of the pump are within ‘685.
‘685 discloses a system for the large-scale production of cells (Abstract) that includes the following limitations for claim 6:
“A system for generating a product enriched in one or more target particles”: ‘685 discloses a system for the production of cells ([0026]) that is fully capable of generating a product enriched
“a cassette to which the one or more microfluidic cartridges are releasably coupled and supported”: ‘685 discloses an instrument module (instrument module; Fig. 2; [0013]) that contains an interface plate (interface plate, i.e. the microfluidic cartridge ; Fig. 6) that contains multiple bioreactors, i.e. channels. Both the instrument module and interface plate are revovably attachable to one another.
“the cassette comprising a plurality of fluidic channels extending longitudinally and spaced apart on the cassette”: ‘685 discloses that the interface plate, i.e. the cassette includes a plurality of channels or tubes that extend in a longitudinal manner along the module and to the plate (Fig. 6; [0055]).
“a plurality of pumps peristaltically coupled to the plurality of fluidic channels to control flow of fluidic content through the plurality of fluidic channels downstream to the one or more microfluidic cartridges for separation of one or more target particles from the sample, without any moving parts from the pumps directly contacting the fluidic content during its flow.”: ‘685 discloses a plurality of pumps through a pump cassette ([0053]) that are used to move the fluid around the module and plate and as a peristaltic pump, the pumps do this without any portion of the pump, i.e. rollers, contacting the fluid ([0052]).
For claim 7, ‘685 discloses using tubing ([0027]) where this is being interpreted as the flexible tubing of the instant application.
For claim 8, ‘685 discloses a set of pump heads of the peristaltic pumps that are coupled to a subset of the channels ([0053]; [0080] of WO 2007/139742 which has been incorporated by reference into ‘685).
For claim 9, ‘685 discloses more than one pump head for the pump cassette (from WO 2007/139742: [0080]; Fig. 8).
For claim 10, the peristaltic pumps of ‘685 would inherently have three rollers.
For claim 11, ‘685 discloses that the fluid channels comprise two or more fluid channels (Fig. 6; from WO 2007/139742: [0080]; Fig. 8).
For claims 12-14, the limitations to the fluidic content is drawn to the material operated on by an apparatus which does not structurally define the claimed invention over the prior art. See MPEP §2115.
For claim 15, the pumps of ‘685 are fully capable of controlling the sample, media solution, a diluent, and waste that is generated from the bioreactor (Fig. 6).
For claim 16, ‘685 discloses that the pumps can be individually controlled to modulate individual flow rates ([0079] from WO 2007/139742).
For claim 19, ‘685 discloses that the pumps have a common shaft ([0080] from WO 2007/139742) and thus have a fixed motion relative to each other.
For claim 20, ‘685 that the fixed shaft allows the pumps to move in the same direction at the same flow rate ([0079] from WO 2007/139742; [0080] from WO 2007/139742).
For claim 23, the pumps of ‘685 are fully capable of being adjusted to control a ratio of the amount of waste relative to sample as the pumps of ‘685 are continuously adjustable.
For claim 24, the pumps of ‘685 are fully capable of being adjusted to be in the same phase ([0079] from WO 2007/139742; [0080] from WO 2007/139742).
For claim 25, ‘685 discloses that the pumps are controllable to have a similar flow rate ([0080] from WO 2007/139742).
For claim 26, the flow can be continually adjusted ([0107] from WO 2007/139742) and therefore can be adjusted in real-time.
For claim 27, the pumps of ‘685 are fully capable of being individually controlled to enable a desired concentration of a target particle ([0079] from WO 2007/139742; [0080] from WO 2007/139742; [0107] from WO 2007/139742).
For claim 28, ‘685 discloses that the pumps are peristaltic pumps.
Therefore, ‘685 meets the limitations for claim 6-16, 19, 20 and 23-28.
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 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.
Claims 10, 17, 18, 21 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Hirshel et al. (US 2015/0225685 A1 – hereafter ‘685) in view of Minarik et a. (CA 2123695 C – hereafter ‘695).
For claims 17, 18 and 22, ‘685 (Hirshel) does not specifically disclose adjusting the phase of each pump, but the step of controlling the peristaltic pumps to be in a different phase from another pump appears to be drawn to the intended use of the pumps and would not define the claimed invention over the prior art. See MPEP §2114. However, assuming arguendo, that this does imply a structural difference, the following rejection applies.
‘695 (Minarik) discloses a peristaltic pump (Abstract) that for claim 17 includes having the pumps with a phase shifted flow (page 7 lines 5-11) for each of the pumps. This is being interpreted as the pumps having a different phase. This results in a reduced pulsation of the flow (page 4 lines 6-9).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to include the phase offset of ‘695 within ‘685 in order to even the flow of media to the bioreactor. The suggestion for doing so at the time would have been in order to reduce the pulsation of the media flow in order to minimize occlusions in the tubing and thus extending the life of the tubes (page 17 lines 8-12).
For claim 18, ‘695 discloses that the pumps out-of-phase actuation is 180° or less (page 3 lines 37 – page 4 line 3).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to include the phase offset of 180° or less as taught by ‘695 within ‘685 in order to even the flow of media to the bioreactor. The suggestion for doing so at the time would have been in order to reduce the pulsation of the media flow in order to minimize occlusions in the tubing and thus extending the life of the tubes (page 17 lines 8-12).
695 (Minarik) discloses a peristaltic pump (Abstract) that for claim 22 includes having the pump heads with a phase shifted flow (page 7 lines 5-11) for each of the pumps. This is being interpreted as the pump heads having a different phase. This results in a reduced pulsation of the flow (page 4 lines 6-9).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to include the phase offset of ‘695 within ‘685 in order to even the flow of media to the bioreactor. The suggestion for doing so at the time would have been in order to reduce the pulsation of the media flow in order to minimize occlusions in the tubing and thus extending the life of the tubes (page 17 lines 8-12).
For claim 21, ‘685 does not disclose having the output of the pumps flow into a single tube.
For claim 21, ‘695 discloses that the output of the pumps (tubes 18; Fig. 1) flow into a manifold (manifold 49; Fig. 1) and are then combined into a single output flow (tubing 53; Fig. 1; page 10 lines 25-29).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to include the manifold and output tubing of ‘695 within ‘685 in order to control the pulsation of the output tube. The suggestion for doing so at the time would have been in order to eliminate reverse flow within the tubes (page 11 lines 24-30).
The following rejection of claim 10 is in the alternative assuming that ‘685 does not inherently disclose rollers for the peristaltic pump.
For claim 10, ‘695 discloses using rollers (rollers 32; Fig. 4; page 5 lines 21-25) to move the fluid through the tube and further discloses at least three rollers.
Therefore, it would have been obvious to one of ordinary skill in the art to employ the rollers of ‘695 within ‘685 in order for the pump to move fluid through the flexible tubes. The suggestion for doing so at the time would have been in order to maintain the sterility of the fluid (i.e. not have any pump parts contacting the fluid) and to have a pulsed flow (page 1 lines 23-25).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Quick et al. (US 2016/0024450 A1) which discloses an automated cartridge for processing a sample.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL L HOBBS whose telephone number is (571)270-3724. The examiner can normally be reached Variable, but generally 8AM-5PM M-F.
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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.
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/MICHAEL L HOBBS/ Primary Examiner, Art Unit 1799