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 .
Priority
Applicant’s claim for the benefit of a prior-filed application (CON of 17/332,371, filed 27 May 2021; which has PRO 63/031,913, filed 29 May 2020) under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Claim Objections
Claim 2 is objected to because of the following informalities:
“wherein the plurality of magnetic features comprise an average width…”.
Claim 3 is objected to because of the following informalities:
“wherein the plurality of magnetic features are spaced apart…”.
Claim 7 is objected to because of the following informalities:
“operatively coupled to the plurality of magnetic features, wherein the plurality of magnetic features are magnetizable”.
Claim 8 is objected to because of the following informalities:
“wherein the plurality of magnetic features comprise…”.
Claim 11 is objected to because of the following informalities:
“wherein the polygonal cross-section is triangular…”.
Claim 22 is objected to because of the following informalities:
“wherein the plurality of magnetic features are spaced apart…”.
Claim 23 is objected to because of the following informalities:
“wherein the plurality of magnetic features are spaced apart…”.
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.
Claim 7 is 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 7, there is insufficient antecedent basis for “the features” in line 2. It is unclear which “features” is referenced because multiple structures have been introduced, each inherently possessing “features”.
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 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.
Claim(s) 1-11 and 19-27 is/are rejected under 35 U.S.C. 103 as obvious over KAPUR et al. (WO 2007/035498) in view of DAVIS et al. (US PGPub 2012/0045828 A1).
Regarding Claim 1, KAPUR discloses a device comprising a reservoir that includes a channel that utilizes “deterministic separation” directing particles based on size and a magnet (pg. 29, lines 5-7; pg. 31, lines 11-12). As shown in FIG. 74 (reproduced below, left), the reservoir contains obstacles that extend from one channel surface toward the opposing channel surface, i.e., extending the entire distance across the channel (pg. 29, lines 21-25). The obstacles are magnetic and attract or retain magnetic particles which are coated with capture moieties or may be target analytes themselves attracted to a magnetic field (pg. 29, lines 26-29).
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As seen in the figure, the reservoir includes an inlet and an outlet (indicated as “Sample in” and “Sample out” in panel B) and includes a plurality of magnetized posts. KAPUR further discloses that this deterministic separation is achieved using an array of gaps and obstacles in the channel (pg. 34, lines 10-12). As further shown in FIG. 1D (reproduced above), obstacles of cylindrical posts having diameters 12 µm and gaps of 8 µm sizes are arranged in an array; in another embodiment, the gap is 24 µm (pg. 36, lines 24-25).
KAPUR is deficient in disclosing a separate magnetic module from a flow module or that the magnetic and flow modules are separable.
DAVIS discloses a device for isolating cells using magnetic rods covered in removable plastic sleeves (i.e., a system for magnetic separation; abstract). The device comprises magnetic members comprising a collection of axially magnetized rods (p0113) arranged as an array (p0020). The magnetic members are held stationary in a fluid flow channel in corresponding hollow pillars or array such that a flow of sample passes by the magnetic members for capture (p0028, p0156; FIG. 16A-D). The corresponding hollow pillars or array covering the magnetic members are nonmagnetic, non-adherent sleeves (p0022), wherein the magnetic members are capable of disengaging from these hollow pillars or array (i.e., wherein the magnetic and flow modules are separable; p0156, FIG. 16A-D). Advantageously, the use of a non-adherent sleeve prevents the direct contact of cells from contacting the magnetic member (p0019) and further facilitates multiple release cycles to assure high capture efficiency and high purity (p0232). Thus, prior to the effective filing date of the claimed invention, one of ordinary skill in the art would have found it obvious to provide separable magnetic and flow modules as taught by DAVIS for the magnetic separation system disclosed by KAPUR.
Regarding Claim 2, modified KAPUR makes obvious the system of Claim 1. KAPUR shows in FIG. 1D that cylindrical posts have diameters of 12 µm, which reads upon the recited average width of from about 1 µm to about 10 mm.
Regarding Claim 3, modified KAPUR makes obvious the system of Claim 1. KAPUR shows in FIG. 1D that cylindrical posts are separated by gaps of 8 µm, which reads upon the recited average distance of from about 1 nm to about 100 µm.
Regarding Claim 4, modified KAPUR makes obvious the system of Claim 3. The prior art is deficient in disclosing that the magnetic features are spaced apart at an average distance of from about 10 nm to about 1 µm. However, because the claimed invention would not perform differently than the system made obvious by modified KAPUR, the claimed invention is not patentably distinct (Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984); MPEP §2144.04). Thus, the claimed average distances by which the plurality of magnetic features are spaced apart would be obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention.
Regarding Claim 5, modified KAPUR makes obvious the system of Claim 1. KAPUR further discloses that the targeted analytes that are attracted to the generated magnetic fields are further collected for analysis or further processing (pg. 21, lines 17-18; pg. 30, lines 26-27). Although KAPUR is deficient in explicitly disclosing a “collection region” as recited, the disclosure that the desired/targeted analytes are collected implies such a recited collection region. "[I]n considering the disclosure of a reference, it is proper to take into account not only specific teachings of the reference but also the inferences which one skilled in the art would reasonably be expected to draw therefrom." In re Preda, 401 F.2d 825, 826, 159 USPQ 342, 344 (CCPA 1968).
Regarding Claim 6, modified KAPUR makes obvious the system of Claim 1. DAVIS further discloses the non-adherent sleeves are 10-30 µm thick (p0079), which reads upon the claimed range of each of the plurality of voids comprises a wall having a thickness of 10 µm to about 10 mm.
Regarding Claims 7 and 8, modified KAPUR makes obvious the system of Claim 1. KAPUR further discloses that the magnetic materials of the disclosed device are fabricated from various magnetic materials, including ferrous compounds (i.e., the magnetic features comprise a ferromagnetic or paramagnetic material; pg. 22, lines 16-19). KAPUR further discloses that the magnetic materials are capable of being magnetized and demagnetized (i.e., a magnet operatively coupled to the features, wherein the magnetic features are magnetizable; pg. 22, lines 21-24).
Regarding Claim 9, modified KAPUR makes obvious the system of Claim 1. KAPUR further discloses the magnetically responsive regions (i.e., the disclosed channels are termed by KAPUR as “magnetically responsive regions”; see pg. 22, lines 11-12) are coated with non-sticking plastic or TEFLON coating (i.e., the flow module comprises plastic, silicone, glass, or silicon; pg. 23, lines 9-10). Similarly, DAVIS further discloses plastic nonadherent sleeves (i.e., wherein the flow module comprises plastic, glass, or silicon; p0078).
Regarding Claim 10, modified KAPUR makes obvious the system of Claim 1. KAPUR further discloses the obstacles have varying shapes, including cylindrical, rectangular, trapezoidal, or pleomorphic (i.e., each of the plurality of voids has a cylindrical or polygonal cross-section; pg. 30, lines 1-2). Similarly, DAVIS further discloses that the magnetic rods and sleeves are preferably cylindrical (i.e., each of the plurality of voids have a cylindrical or polygonal cross-section; p0121).
Regarding Claim 11, modified KAPUR makes obvious the system of Claim 1. KAPUR further discloses the obstacles have varying shapes, including cylindrical, rectangular, trapezoidal, or pleomorphic (i.e., wherein the cross-section is triangular or rectangular; pg. 30, lines 1-2).
Regarding Claim 19, modified KAPUR makes obvious the system of Claim 1. KAPUR further discloses that the magnetic obstacles are ordered in a two-dimensional array (i.e., the plurality of voids is arranged in a two-dimensional array; pg. 6, lines 26-27).
Regarding Claim 20, modified KAPUR makes obvious the system of Claim 1. KAPUR further discloses in FIG. 74 the reservoir contains obstacles that extend from one channel surface toward the opposing channel surface, i.e., extending the entire distance across the channel (i.e., each of the plurality of voids has a height that extends across the sorting region of the flow module; pg. 29, lines 21-25).
Regarding Claim 21, modified KAPUR makes obvious the system of Claim 1. KAPUR further discloses that the magnetic obstacles are ordered in a two-dimensional array (i.e., the plurality of voids is arranged in a two-dimensional array; pg. 6, lines 26-27). KAPUR further discloses in FIG. 74 the reservoir contains obstacles that extend from one channel surface toward the opposing channel surface, i.e., extending the entire distance across the channel (i.e., each of the plurality of voids has a height that extends across the sorting region of the flow module; pg. 29, lines 21-25).
Regarding Claim 22, modified KAPUR makes obvious the system of Claim 3. KAPUR shows in FIG. 1D that cylindrical posts are separated by gaps of 8 µm, which reads upon the recited average distance of from about 5 µm to about 10 µm.
Regarding Claim 23, modified KAPUR makes obvious the system of Claim 3. KAPUR shows in FIG. 1D that cylindrical posts are separated by gaps of 8 µm. The prior art is deficient in disclosing that the magnetic features are spaced apart at an average distance of from about 10 µm to about 50 µm. However, because the claimed invention would not perform differently than the system made obvious by modified KAPUR, the claimed invention is not patentably distinct (Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984); MPEP §2144.04). Thus, the claimed average distances by which the plurality of magnetic features are spaced apart would be obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention.
Regarding Claims 24-26, modified KAPUR makes obvious the system of Claim 1. KAPUR further discloses that the target analyte separated by the disclosed system is a cell (i.e., the biological particle is a cell (Claim 26); pg. 7, lines 20-22). KAPUR further discloses the system provides a reagent including a plurality of magnetic particles (i.e., wherein the particles are magnetic particles (Claim 24); pg. 8, lines 11-14) whereby these magnetic particles are incubated with the cells for a time sufficient to allow for the cell to internalize the magnetic particles to enable the capture of cells with internalized magnetic particle (i.e., the magnetic particles are attached to a biological particle or a macromolecular constituent thereof (Claim 25); pg. 9, lines 1-11).
Regarding Claim 27, as described in the rejection of Claim 1, modified KAPUR makes obvious the system of Claim 1. KAPUR further discloses the system provides a reagent including a plurality of magnetic particles (i.e., [a] kit comprising the system of claim 1 and magnetic particles; pg. 8, lines 11-14).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RYAN B HUANG whose telephone number is (571)270-0327. The examiner can normally be reached 9 am-5 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, In Suk Bullock can be reached on 571-272-5954. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Ryan B Huang/Primary Examiner, Art Unit 1777
Prosecution Insights