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 . This is a first action on the merits of the application.
Priority
Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file.
Status of the Application
This action is a first action on the merits in response to the application filed on 05/11/2023.
Election/Restrictions
Applicant's election with traverse of group I, claims 1-11 and 25-26 in the reply filed on 02/04/2026 is acknowledged. The traversal is on the ground(s) that the claim amendment introduced on 02/04/2026 has introduced a subject matter of “activating the first electromagnetic trap and introducing a flow of the fluid sample is performed substantially simultaneously” that the applicant deemed a special technical feature over Anderson (6,649,419) (see arguments 02/04/2026, page 7, last two paragraphs through page 8, 1st paragraph). This is not found persuasive because simultaneous introduction of magnetic particles and fluid sample was known in the art, as evidenced by Yanik (US 2019/0346435 Al) which teaches simultaneous introduction through separate inlets (see the rejection of claim 10 over Yanik included in this office action below). Accordingly, the limitation does not represent a technical contribution over prior art and does not affect the distinctness and search burden underlying the restriction requirement. The requirement is still deemed proper and is therefore made FINAL.
Claims 12-17 and 19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention (Group II), there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 02/04/2026.
Claim Status
Claims 1-17, 19 and 25-26 filed on 02/04/2026 are currently pending in the application. Claims 1-11 and 25-26 have been examined. Claim 12-17 and 19 are withdrawn from further consideration pursuant to the restriction requirement.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 04/04/2024; 09/30/2025, 12/19/2025 and 06/10/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Objections
Claim 7 is objected to because of the following informalities:
Claim 7 states: “wherein the AC current received by the first electromagnetic trap mixes the magnetic particles”. An “AC current” itself does not literally mix particles. Alternatively, the phrase “wherein the AC current received by the first electromagnetic trap causes the magnetic particles to vibrate and mix with the fluid sample” could be used. Appropriate correction is required.
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 1-11 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 pre-AIA the applicant regards as the invention.
Independent claim 1 recites the limitation “Introducing a flow of fluid sample are performed substantially simultaneously”. Similar language appears in claims 4 and 6. The phrase “substantially simultaneously” is a term of degree and the specification does not provide an objective standard for determining the degree of temporal overlap required between the recited operations.
Accordingly, one of ordinary skill in the art would not be reasonably apprised of the scope of the claims because it is unclear what amount of temporal separation between the recited operations would still fall within the scope of “substantially simultaneously”. For example, the claims do not indicate whether a delay of milliseconds, seconds or minutes between activation of the electromagnetic trap and initiation of fluid flow would satisfy the limitation.
Therefore, the metes and bounds of the claimed invention cannot be determined with reasonable certainty and claims 1, 4 and 6 are indefinite under 35 U.S.C. 112(b).
As for claim 11, the term “about” is a term of approximation. The specification fails to provide objective boundaries for determining the degree of approximation encompassed by the term “about” when used in connection with the recited flow rate. Specifically, it is unclear what range of flow rates would be considered about 1 liter per minute and therefore fall within the scope of the claim.
Claims 2-11 are rejected for their dependency upon rejected claim 1.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Lowrey et al (WO 2012054588A2; hereinafter Lowrey).
Regarding claim 1, Lowrey teaches processing a fluid sample containing a first target analyte (This invention features devices and methods for analyte processing and detection; page 1; line 5), the method comprising: introducing a first batch of magnetic particles (magnetic particles having binding moieties, page 2; line 1) into a fluid conduit, the fluid conduit comprising a first open end, a second open end (a device that includes: (a) a conduit including: (al) a conduit inlet configured for introduction of a sample at a first site of the conduit; (a2) a conduit outlet at a second site of the conduit, page 1; lines 30-32) and a first electromagnetic trap between the first open end and the second open end (a plurality of magnets disposed downstream of the conduit inlet, page 1; lines 33-34), wherein the magnetic particles comprise a first receptor to bind the first target analyte in the fluid sample (magnetic particles having binding moieties, page 2; line 1); activating the first electromagnetic trap to trap and mix the magnetic particles within the first electromagnetic trap (adjusting one said magnet among said selected magnets of step (a) that is downstream from said conduit inlet to create a magnetic field gradient inside said conduit corresponding to said magnet of sufficient strength to hold said magnetic particles of one said sample in a particular volume in said corresponding conduit proximal to said magnet; page 112; claim 37 b); introducing a flow of the fluid sample through the fluid conduit from the first open end to the second open end (fluidic actuation device is capable of generating a plurality of flow rates, including reversed flow, in one or more of said conduits, page 115 ; claim 44) and deactivating the first electromagnetic trap to release the magnetic particles from the first electromagnetic trap (magnetization/demagnetization cycling occurs to enhance binding
and clustering. The flow through the conduit is then conducted and the nanoparticles are
released to the detector module for determination of presence/absence of analyte molecule; page 72; lines 33-35).
Lowrey does not teach activating the first electromagnetic trap and introducing a flow of the fluid sample are performed substantially simultaneously. However, Lowrey teaches repeatedly performing analyte capture operations for multiple samples (Lowrey; claim 37). During normal operations of such a system, a skilled artisan would have understood that activation of the electromagnetic trap and introduction of the fluid sample would routinely occur concurrently so that the analyte capture may commence immediately upon introduction of the sample into the conduit. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to perform activation of the electromagnetic trap and introduction of a fluid flow at the same time because doing so would have increased processing efficiency and throughput by allowing analyte capture to occur while fluid is actively flowing through the conduit, thereby reducing processing time and improving interaction between the magnetic particles and the fluid sample. Performing these operations concurrently represent nothing more than an obvious optimization of the sequence of known process steps to obtain predictable results.
Claims 2 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Lowrey in view of Pagano et al (US 2011/0003303 A1; hereinafter Pagano).
As for claim 2, Lowrey teaches devices and methods for analyte processing and detection similar to claim1. Lowrey does not expressly disclose switching an electrical signal supplied to the electromagnetic trap from DC current to AC current. Pagano teaches oscillating magnetic fields for inducing particle movement and mixing (moving a magnetic field as by, for example, oscillating the field; paragraph [0121]).
Lowrey and Pagano are considered to be analogous to the claimed invention because both are in the same field of developing methods for analyzing a fluid sample using trapped magnetic particles.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the control scheme of Lowrey to switch from DC current, which retains particles within the trap, to AC current, which agitates and mixes particles, in order to improve interactions between the magnetic particles and target analytes while employing electromagnetic control techniques for the established purpose.
As for claim 7, Pagano teaches oscillating magnetic fields that induce movement and mixing of magnetic particles (The same mechanisms for facilitating mixing may be employed; e.g., a moving a magnetic field as by, for example, oscillating the field; paragraph [0121]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to utilize AC current in the electromagnetic trap of Lowrey to generate an oscillating magnetic field that mixes the trapped particles in order to increase particle motion and improve analyte capture.
Claims 3-6, 8-9 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Lowrey
As for claim 3, Lowrey teaches adjusting the magnet to create a magnetic field gradient inside the corresponding conduit of insufficient strength to hold the magnetic particles thereby releasing the magnetic particles (page 10; lines 7-10). Therefore, it would have been obvious to adjust or terminate the electrical signal in the electromagnet, following a mixing operation in order to release the particles from the trap and permit downstream processing, which is the predictable use of a common electromagnet operation.
As for claim 4. Lowrey does not disclose introducing the magnetic particles and introducing the fluid sample “substantially simultaneously”. Note that the term “substantially simultaneously” is indefinite as described above. Also note that the application documents lack disclosure as to how to introduce the magnetic particles and the fluid sample at the same time. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to introduce the magnetic particles and the fluid sample at the same time because doing so would allow magnetic particles to immediately interact with analytes present in the fluid sample, thereby reducing analyte capture time and reducing overall processing time of samples. This represents a predictable variation of the operation sequence to yield expected results.
As for claim 5, Lowrey teaches flowing the fluid sample through the first electromagnetic trap between the first open end and the second open end (causing the sample including the plurality of analytes to flow along the corresponding conduit or plurality of conduits and interact with each of the magnetic particles held within the conduit or plurality of conduits. page 10; lines 2-5).
As for claim 6. Lowrey teaches trapping magnetic particles while fluid flows through the conduit (causing said sample comprising said plurality of analytes to flow along said conduit or said plurality of conduits and interact with each of said magnetic particles held within said conduit or said plurality of conduits; claim 37-e). Alternatively, simultaneous trapping and fluid flow would have been an obvious operation mode for the reasons discussed with respect to claim 4 because continuous-flow magnetic separation systems conventionally retain particles while sample fluid is passed through the trapping region.
As for claim 8, Lowrey teaches a method for processing a fluid sample using magnetic particles and an electromagnetic trap, including trapping the particles within the conduit and subsequently releasing the particles by deactivating the electromagnetic trap. Lowrey does not teach collecting the magnetic particles after release form the first electromagnetic trap in a collection apparatus as recited in claim 8.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to collect the magnetic particles after release from the electromagnetic trap because the magnetic particles carry the captured target analyte and are intended for subsequent analysis. Collecting the released particles represent a necessary step following magnetic separation and would have been performed to preserve the particles and bound analytes for their intended use.
As for claim 9, Lowrey teaches a fluid processing system including multiple electromagnets positioned along a fluid conduit for selectively trapping and manipulating magnetic particles within the conduit (a plurality of magnets disposed downstream of the conduit inlet along at least a portion of the length of the conduit; page 1; lines 33-34). Claim 9 differs from claim 1 in reciting a second electromagnetic trap. Therefore, providing an additional electromagnetic trap would have been obvious to one of ordinary skill in the art because multiple trapping regions permit sequential processing of the magnetic particles. The use of additional electromagnets merely represents the predictable duplication of known elements performing the same function to yield predictable results. Accordingly, claim 9 would have been obvious over Lowrey.
As for claim 11, Lowrey teaches a fluid processing system including magnetic particles, a fluid conduit and electromagnetic traps for trapping magnetic particles. Lowrey also teaches flowing a fluid sample through the conduit during magnetic particle trapping, However, Lowrey does not disclose a flow rate about 1 L/min as recited in claim 11.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to select a flow rate of about 1 L/min because flow rate is a result-effective variable that affect sample throughput and processing efficiency. A skilled artisan would have been motivated to optimize and scale up or down the flow rate based on the desired processing capacity and system requirement through routine experimentation. Increasing the flow rate to process a larger sample volume in a shorter time would have been no more than the predictable use of prior art elements according to their established functions. Applicant has not identified, nor does the specification disclose, any criticality associated with the claimed flow rate threshold or any unexpected results achieved thereby. Accordingly, claim 11 would have been obvious over Lowrey.
Claims 10 is rejected under 35 U.S.C. 103 as being unpatentable over Lowrey in view of Yanik et al (US 2019/0346435 Al; hereinafter Yanik).
As for claim 10, Lowrey teaches a fluid processing system including magnetic particles, a fluid conduit and multiple magnetic trapping locations for trapping magnetic particles (as discussed above). Lowrey does not teach a second introduction channel upstream of a second electromagnetic trap as recited in claim 10. Yanik teaches a fluid processing system having multiple inlet channels for introducing fluids and particles into the system (Figure 7 showing an inlet for magnetic particles, an inlet for the fluid sample and two additional inlets, all upstream of the magnetic trap). Yanik teaches that separate inlet channels may be provided upstream of processing regions to permit independent introduction of samples, reagents and particles. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the system of Lowrey to include a second introduction channel upstream of a second electromagnetic trap as taught by Yanik in order to permit the independent introduction of fluids, reagents or magnetic particles into separate processing regions for the benefit of increasing operational flexibility and controlling particle processing at multiple trapping locations.
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Lowrey
As for claim 25, it recites that the first electromagnetic trap is defined by a first volume and that the fluid sample comprises a second volume greater than the first volume.
Lowrey teaches
a method for processing a fluid sample containing a first target analyte (This invention features devices and methods for analyte processing and detection; page 1; line 5), the method comprising: introducing a first batch of magnetic particles (magnetic particles having binding moieties, page 2; line 1) into a fluid conduit, the fluid conduit comprising a first open end, a second open end (a device that includes: (a) a conduit including: (al) a conduit inlet configured for introduction of a sample at a first site of the conduit; (a2) a conduit outlet at a second site of the conduit, page 1; lines 30-32), and a first electromagnetic trap between the first open end and the second open end (a plurality of magnets disposed downstream of the conduit inlet, page 1; lines 33-34), wherein the first electromagnetic trap is defined by a first volume, and wherein the magnetic particles comprise a first receptor to bind the first target analyte in the fluid sample (magnetic particles having binding moieties, page 2; line 1); and introducing a flow of the fluid sample through the fluid conduit from the first open end to the second open end (fluidic actuation device is capable of generating a plurality of flow rates, including reversed flow, in one or more of said conduits, page 115 ; claim 44), wherein the fluid sample comprises a second volume greater than the first volume.
Lowrey does not expressly quantify the relative volumes of the electromagnetic trap and the fluid sample.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to use a volume of fluid sample processed through the conduit that would ordinarily exceed the volume occupied by the localized magnetic trapping region. Processing a sample volume greater than the trapping volume permits to maximize analyte recovery from larger sample quantities while utilizing the magnetic trap for its intended purpose of retaining particles within a confined region and represents the ordinary mode of operation of a flow through magnetic separation system.
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Lowrey in view of Pagano
As for claim 26, claim 26 depends from claim 25 and further recites that activating the first electromagnetic trap comprises activating the trap to trap and mix the magnetic particles.
Lowrey teaches activation of the electromagnetic trap to trap magnetic particles within the trapping region (adjusting one said magnet among said selected magnets of step (a) that is downstream from said conduit inlet to create a magnetic field gradient inside said conduit corresponding to said magnet of sufficient strength to hold said magnetic particles of one said sample in a particular volume in said corresponding conduit proximal to said magnet; page 112; claim 37 b). Lowrey does not teach mixing the particles within the first electromagnetic trap. Pagano teaches the use of varying or oscillating magnetic fields to induce movement and mixing of magnetic particles within a magnetic captured zone Pagano teaches oscillating magnetic fields for inducing particle movement and mixing (moving a magnetic field as by, for example, oscillating the field; paragraph [0121]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the control scheme of Lowrey to switch from DC current, which retains particles within the trap, to AC current, which agitates and mixes particles, in order to improve interactions between the magnetic particles and target analytes while employing electromagnetic control techniques for the established purpose.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Bachar EL Haj Hassan whose telephone number is (571)270-0121. The examiner can normally be reached on Monday-Friday 9AM-5PM.
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/BACHAR EL HAJ HASSAN/Examiner, Art Unit 1772
/JONATHAN MILLER/Primary Examiner, Art Unit 1772
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