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 .
Status of Claims
Claims 1-6, 11, 13-14, 17-19, 21, 24, 26-29 and 31-32 are pending. Claims 29 and 31-32 have been withdrawn as drawn to a non-elected invention. Claims 1-6, 11, 13-14, 17-19, 21, 24, 26-28 have been examined.
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-6, 11, 13-14, 17-19, 21, 24, 26-28, in the reply filed on 10/27/2025 is acknowledged. The traversal is on the ground(s) that there would not be a serious burden on the Examiner since the identified inventions aren’t necessarily classifiable in distinct classifications, as described in MPEP 803. This is not found persuasive because this application is a 371 of PCT/US2020/060653 and thus is subject to the requirement for unit of invention as provided in 37 CFR 1.475(a). As described in the Restriction Requirement mailed 08/27/2025, 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 feature. Even though the inventions of Group I and Group II require the common technical feature of beads attached to a field of surface-attached microposts, this technical feature is not a special technical feature as it is taught by Bergman et al. (see paragraphs 0017, 0024 and 0073).
The requirement is still deemed proper and is therefore made FINAL.
Priority
This application 17/776,797 (PGPub: US2022/0395834) was filed 05/13/2022. This application is a 371 of PCT/US2020/060653 filed 11/15/2019, which claims benefit of US Provisional Application 62/936,263 filed 11/16/2020 and 63/053,887 filed 07/20/2020.
Information Disclosure Statement
The Information Disclosure Statements filed 05/13/2022, 01/10/2024, 03/14/2024, 10/04/2024, 03/07/2025 have been 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 13, 18-19 and 26 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.
Regarding claim 13, the parenthetical reference to latent “(latent)” renders the claim(s) indefinite because the claim(s) include(s) elements not actually disclosed (those encompassed in the parenthesis), thereby rendering the scope of the claim(s) unascertainable. See MPEP § 2173.05(d).
Claim 18 recites “the magnetically-responsive microposts” and this limitation lacks antecedent basis as no magnetically responsive microposts have been recited in any of the claims from which claim 18 depends.
Claim 19 recites that “the surface-attached microposts are functionalized with a plurality of beads” and is unclear if these plurality of beads are the same as the beads attached to the microposts as in claim 1 or if another set of beads are included in the instrument.
Claim 26 is indefinite because it recites “thereby contacting the beads attached to the field of microposts” and as the claim is recited, it is unclear what is contacting the beads as they are already recited as being attached to the field of microposts.
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) 1-6, 11 and 13-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Liu et al., (Electrophoresis 2007, 28, 4713-4722, hereinafter “Liu”).
Regarding claim 1, Liu teaches throughout the publication a microfluidic cartridge (abstract, integrated smart microfluidic device) comprising:
a. a housing forming a reaction chamber (page 4715, section 2.3.1 and Figure 1a);
b. a field of surface-attached microposts provided on an interior surface of the housing and extending into the reaction chamber (see Figures 1A and 2; page 4715, section 2.3.2, nickel micropillars in a microchannel); and
c. beads attached to the microposts (see Figure 3 and page 4717, section 2.4, superparamagnetic beads trapped by the micropillars); and
wherein the bead comprises a core that is covered by a polymer shell and the polymer shell provides a surface for a subsequent functionalization reaction or reactions, and the core further comprises a magnetically-responsive material (page 4714, left column, first paragraph carried over from page 4713, superparamagnetic beads with iron oxide crystal core in a polymer shell; page 4714, section 2.1, superparamagnetic beads with carboxyl groups on the surface and page 4717, section 2.4, biofunctionalization of beads).
Regarding claim 2, Liu teaches the cartridge wherein the reaction chamber further comprises openings arranged for flowing fluid into and out of the chamber (page 4715, section 2.3.1 and Figure 1, inlets and outlets).
Regarding claim 3, Liu teaches the cartridge wherein the housing comprises two substrates separated to form the reaction chamber as a gap between the substrates (page 4715, Figure 1a, top and bottom of microchannel).
Regarding claim 4, Liu teaches the cartridge wherein the beads are functionalized (page 4718, section 3.4, biofunctionalization of beads).
Regarding claim 5, Liu teaches the cartridge wherein the surface-attached microposts comprise magnetically-responsive microposts that can be actuated using a magnetic actuation mechanism (page 4717, section 2.4, external magnetic field magnetized micropillars).
Regarding claim 6, Liu teaches the cartridge wherein the beads comprise target-specific beads, wherein the target-specific beads are pre-functionalized with a binding agent that is specific for one or more targets of interest (page 4717, section 2.4 and page 4719, section 3.5, WGA immobilized on surface of the beads to capture A549 cancer cells), the pre-functionalized beads are bound to the surface-attached microposts using non-specific adsorption of the beads to the microposts (page 4717, section 3.3).
Regarding claim 11, while Liu teaches that the beads incorporate carboxyl groups on their surface (page 4717, section 2.4), the reference does not explicitly teach that a chemical bonding reaction is used to adhere a magnetically-responsive bead to the surface of a micropost. However, process of chemical bonding the beads to the microposts is a product x process limitation. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted) (See MPEP 2113). In the instant case, the product of beads adhered to the surface of the microposts is the same as taught by Liu and thus the limitation is unpatentable even though the prior art attachment was made by a different process.
Regarding claim 13, Liu teaches the cartridge wherein a remnant (latent) magnetic field is generated in the surface-attached microposts, thereby attracting and binding the beads to the microposts via magnetism (pages 4717-4718, section 3.3, remnant magnetic field allowed beads to remain attached to pillars).
Regarding claim 14, Liu teaches the cartridge wherein the beads are bound to at least one substrate surface of the reaction chamber by an ambient magnetic field (See Figure 3).
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, 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) 17 is rejected under 35 U.S.C. 103 as being unpatentable over Liu et al., (Electrophoresis 2007, 28, 4713-4722, hereinafter “Liu”) as applied to claim 1 above, and further in view of Rackus et al (WO 2017/219122, Pub Date: 12/28/2017, hereinafter “Rackus”).
Regarding claim 17, while Liu teaches the cartridge wherein the superparamagnetic beads have a polymer shell (page 4714, first paragraph carried over from previous page), the reference fails to specifically teach that the polymer shell is selected from the group consisting of a polystyrene or a silica-based material.
Rackus teaches throughout the publication methods for concentrating analyte from large samples using magnetic microparticles on microfluidic devices (abstract). More specifically, Rackus teaches that the particles used can be paramagnetic iron oxide cores encapsulated with a polymer shell such as polystyrene (page 6, last paragraph).
It would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to incorporate as the polymer shell of the beads of Liu, a polystyrene shell as taught by Rackus because Liu is generic regarding the polymer shell that can be used and one skilled in the art would have been motivated to choose the appropriate polymer shell material based on the desired surface properties.
Claim(s) 18-19, 21, 24 and 26-28 are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al., (Electrophoresis 2007, 28, 4713-4722, hereinafter “Liu”) as applied to claim 1 above, and further in view of Spero et al (US 2018/0266951, Pub Date: 09/20/2018, hereinafter “Spero”).
Regarding claim 18, Liu teaches the microfluidic cartridge comprising an array or magnetically-responsive pillars, as described above. However, Liu fails to teach an instrument comprising: a. an actuation mechanism, wherein the actuation mechanism generates an actuation force thereby compelling at least a portion of the magnetically-responsive microposts to move, and wherein the actuation force is selected from the group consisting of a magnetic, thermal, sonic, and/or electric force.
Spero teaches throughout the publication a flow chamber including surface-attached structures in a chamber (abstract). More specifically, Spero teaches a driver configured applying a magnetic force, electric force or other actuation force to the interior of the chamber to actuate movement of the surface attached structures (paragraph 0013). Additionally, the surface attached structure can include an end fixed to a substrate and a free end and have a rounded, polygonal or irregular shape (such as pillars or posts) while being characterized as movable relative to its fixed end (paragraphs 0061-0063).
It would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to substitute for the micropillars in the cartridge of Liu, surface-attached structures controlled by an actuator as taught by Spero because it would have been no more than the simple substitution of one magnetically responsive surface-attached pillar for another well-known in the art. One skilled in the art would have had a reasonable expectation of success in utilizing the surface attached structures and driver to actuate the structures of Spero in place of the micropillars in the cartridge of Liu since Liu teaches that the presence of micropillars increases magnetic capture efficiency of beads (Liu, page 4718, left column) and Spero teaches that the surface-attached structures incorporate a binding material and magnetic component at the free end of the structure (paragraph 0089) while there is no limitation on the manner in which the binding agent is disposed on the outer surface of the surface attached structure (paragraph 0092), thus allowing the structures to be utilized with the functionalized superparamagnetic beads of Liu.
Regarding claim 19, Liu in view of Spero teach the instrument wherein the surface-attached microposts are functionalized with a plurality of beads for specific binding of one or more targets of interest (Liu, see Figure 3).
Regarding claim 21, Liu in view of Spero teach the instrument wherein the microposts are pre- magnetized to create a magnetic field in the microposts and then magnetically-responsive beads are bound to the microposts, whereby the beads provide a surface for binding one or more targets of interest, and wherein the beads comprise a superparamagnetic material (Liu, page 4717, section 2.4; Spero, paragraph 0065).
Regarding claim 24, Liu in view of Spero teach the instrument wherein the bead is pre-coupled with a ligand, and wherein the ligand is selected from the group consisting of an antibody, a protein, an antigen, a DNA/RNA probe, or any other molecule with an affinity for one or more targets of interest (Liu, page 4719, section 3.5).
Regarding claim 26, Liu in view of Spero teach a method of capturing a target, the method comprising: a. providing the instrument of claim 18 (see teachings of Liu in view of Spero described above); b. causing a sample comprising the target to flow through the reaction chamber (page 4719, section 3.5, A549 cell suspension introduced into the microchannel); and c. causing the actuation mechanism to generate an actuation force thereby compelling at least a portion of the magnetically-responsive microposts to move (Spero, paragraph 0013); thereby contacting the beads attached to the field of microposts and thereby causing the target to bind to the beads (Liu, page 4717, section 2.4).
Regarding claim 27, Liu in view of Spero teach the method further comprising: a. causing a wash buffer to flow through the reaction chamber; and b. causing the actuation mechanism to generate an actuation force thereby compelling at least a portion of the magnetically-responsive microposts to move; thereby washing the beads (Liu, page 4717, section 2.4, washing step; Spero, paragraph 0013, actuating and paragraph 0124, wash step).
Regarding claim 28, Liu in view of Spero teach the method further comprising: a. causing an elution buffer to flow through the reaction chamber; and b. causing the actuation mechanism to generate an actuation force thereby compelling at least a portion of the magnetically-responsive microposts to move; thereby eluting the target from the beads (Liu, page 4717, section 2.4, elution step; Spero, paragraph 0013, actuating and paragraph 0102, elution buffer and actuating).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA M GIERE whose telephone number is (571)272-5084. The examiner can normally be reached M-F 8:30-4:30.
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/REBECCA M GIERE/Primary Examiner, Art Unit 1677