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 .
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.
Status of Claims
Claims 1-17 are pending and under examination.
Withdrawn Rejections
In light of the amendments, the previous 35. U.S.C. 112(b) rejections are hereby withdrawn.
In light of the amendments, the previous 35. U.S.C. 102(a)(1) rejection is hereby withdrawn.
New Rejections
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-17 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. New Matter Rejection.
Amended claim 1 recites “each annular subzone extending continuously around a circumference of the magnetically-modified microsphere body, and each of the plurality of annular subzones comprises a capture zone, a detection zone, and a center of gravity (CG) adjustment zone sequentially from top to bottom”. Applicant has cited para. [0006] and Fig. 1 for the supports of the amendments.
Para. [0006] and Fig. 1 do not provide supports for each annular subzone extending continuously around a circumference of the magnetically-modified microsphere comprises (1) a capture zone, (2) a detection zone, and (3) a center of gravity (CG) adjustment zone. In particular, Fig. 1 and para. [0021] of the specification explicitly indicate that, for example, the center of gravity (CG) subzone is only at the bottom half of the microsphere body. Because the specification is limited, the examiner was not able to find support in the instant specification with respect to each annular subzone comprises (1) a capture zone, (2) a detection zone, and (3) a center of gravity (CG) adjustment zone. Claims 2-17 are rejected as being dependent from claim 1.
For the reasons above, the specification fails to provide direction or blaze marks to the above claimed limitation.
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 1-17 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.
The amended Claim 1 recites “each annular subzone extending continuously around a circumference of the magnetically-modified microsphere body, and each of the plurality of annular subzones comprises a capture zone, a detection zone, and a center of gravity (CG) adjustment zone sequentially from top to bottom” is unclear to the metes and bounds of whether “each of the plurality of annular subzones are referring to “each subzone” or “each plurality”. Because the claim only recites a single microsphere body, it is unclear to the construct of the microsphere body with recitations that contain the phrase each. Claims 2-17 are rejected as being dependent from claim 1.
In addition, claim 1 also recites the phrase “microsphere possessing a divisional functionalization modification” and “each annular subzone extending continuously around a circumference of the magnetically-modified microsphere body”. The interpretation of a microsphere is that it has at least a micrometer of diameter. Meanwhile claims 3 and 12 recite that the capture zone (e.g., a subzone) has a diameter in the nanometer. Also claim 4 and 13 recite that the microsphere possessing a diameter of 0.5µm. Because the phrase “microsphere” has not been defined in the specification, it is unclear how a microsphere possesses a diameter that is not equal or greater than 1µm and capture zone of 15 nm be able to extend continuously around a circumference of at least a micrometer particle. Claims 2-17 are rejected as being dependent from 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, 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.
Claims 1-17 are rejected under 35 U.S.C. 103 as being unpatentable over Xu, Fangcheng (CN113265379A, published 08/17/2021, this document is not an English document. Therefore, the cited passages are from EPO machine translation; hereafter: Xu, see PTO-892 dated 1/20/2026) in view of Swager et al. (US2021/0080456A1, published 03/18/2021).
With respect to claims 1 and 9, Xu teaches a microsphere with functionalized spots on the surface and the microsphere comprises a microsphere main body and the functionalized spots embedded in the top of the microsphere main body, a gravity ball is embedded in the bottom of the microsphere main and the gravity ball is used for adjusting the gravity center of the microsphere main body to keep the functionalized spots upward (abstract). Xu further teaches in the abstract that the microspheres with the functionalized spots can be used for adsorption and separation of bioactive particles. Xu teaches the surface is modified with quantum dots and the inside is modified with magnetism (see machine translation, pg. 2, paras. 4-5 of Summary of the invention). Xu further teaches a single virus particle is adsorbed on the functionalized spots, and the surface of the microsphere body does not adsorb biological particles and the surface is modified with fluorescence or quantum dots and the inside is modified with magnetic (see machine translation, pg. 4, para. 4). Xu teaches the main body of the microspheres adopts polystyrene magnetic microspheres or silica magnetic microsphere (see machine translation, pg. 2, para. 5 of Summary of the invention). Fig. 1 is reproduced from CN113265379A:
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Fig. 1 reads on a microsphere comprising: a magnetically-modified microsphere body, wherein a surface of the magnetically-modified microsphere body is provided with a plurality of annular subzones, and each of the plurality of annular subzones comprises a capture zone, a detection zone, and a center of gravity (CG) adjustment zone sequentially from top to bottom; a surface of the capture zone is subjected to a bioactive modification such that the surface of the capture zone has an activity to capture a biological particle or molecule; the detection zone is modified by fluorescence or a quantum dot (QD) for an optical detection; a surface of the CG adjustment zone is coated with a coating, and the coating has a greater specific gravity than the magnetically-modified microsphere body; and the CG adjustment zone is configured to adjust a CG of the magnetically-modified microsphere body to keep the capture zone facing up.
Additionally, Xu teaches an application of microspheres with functionalized spots on the surface and the microspheres are used for adsorption and separation of biological active particles wherein the an microsphere array with functionalized spots on the surface on the first chip containing the micropore array and adding a solution containing biologically active particles to the surface of the first chip, and the biologically active particles are adsorbed on the functionalized spots of the microspheres (see machine translation of Summary of the invention, page 3, paras. 16-20). Xu further teaches washing off excess biologically active particles, cover the second chip, and transfer the microspheres with adsorbed biologically active particles to the second chip by magnetic adsorption (see machine translation of Summary of the invention, page 4, paras. 16-20). Xu teaches the functionalized spots have the adsorption characteristics and the diameter is 15nm to 30 µm (see machine translation, pg. 3, para. 2).
Xu does not explicitly teach each annular subzone extending continuously around a circumference of the magnetically-modified microsphere body (claim 1) and washing the chip multiple times with PBS or deionized water (claim 9).
Swager teaches systems and methods may allow for a relatively simple and rapid way for detecting analytes such as chemical and/or biological analytes and may be useful in numerous applications including sensing, detecting proteins and detecting of DNA (see abstract). Swager teaches in Fig. 1 a system 100 comprises a plurality of Janus droplets such as Janus droplet 120 comprising the first phase 130 (comprising a hydrocarbon) and second phase 140 (comprising a fluorocarbon) (see para. [0185]). Swager teaches the Janus droplet may rotate upon exposure to the analyte (e.g., upon binding of the analyte with a binding moiety associated with the Janus droplet) (see para. [0186]). Fig. 1 show that the Janus has annular subzone extending continuously around a circumference of the sphere. Swager teaches the Janus droplets may include a magnetic phase (i.e., including ferromagnetic particles) (see para. [0195]). Swager teaches the continuous phase to increase the hydrocarbon-water surface area for bioconjugation (see para. [0354]). Swager teaches rinsed thoroughly with distilled water (see para. [0334]). Swager further teaches protein A was dissolved in PBS buffer (see para. [0356]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have extended/expanded the different components of the magnetic microsphere as taught by Xu by continuously forming on the particle as taught by Swager because Xu’s purpose is to functionalize the surface of the magnetic microsphere for specific biological target molecules and Swager teaches that in a particle with a continuous surface area increases bioconjugation on a particle. Therefore, it would have been obvious to the artisan to have expanded the different components of Xu’s magnetic microspheres to be continuous on the microsphere because (1) Xu has established theat surface component 1 is continuously coating the microsphere (see Fig. 1) with fluorescence or quantum dots, (2) the functionalized spots have the ability to expand in a diameter range from 15nm to 30µm and (3) Swager establishes higher surface area extends the ability to bioconjugate target molecules on different angles of the magnetic microsphere.
Additionally, with respect to claim 9, it would have been obvious to the person to have washed thoroughly the excess of Xu’s biological target molecules with distilled water (deionized) or PBS of Swager because these reagents are recognized in the art for rinsing excess materials and/or use with biological target molecules as buffers.
The person would have a reasonable expectation of success in expanding the different components on the particle because Xu and Swager have recognized the ability to form different components on magnetic particles. Additionally, Xu teaches the functionalized spots have the ability to expand in a diameter range from 15nm to 30µm.
With respect to claims 2 and 11, Xu teaches the micro-nanosphere modified by amino, carboxyl, hydroxyl, or streptavidin (see machine translation, pg. 3, para. 6).
With respect to claims 3 and 12, Xu teaches the functionalized spots have the adsorption characteristics and the diameter is 15nm to 30 µm (see machine translation, pg. 3, para. 2).
With respect to claims 4 and 13, Xu teaches the diameter of the gravity ball is 30% to 50% of the main body of the microsphere (see machine translation, pg. 3, para. 1; and Fig. 1), which is within the claimed range of 1/4 to 3/4. Xu teaches nano film on the body of the microsphere (see machine translation, pg. 5, para. 6-7). Xu teaches a nano film (i.e., coating) has a thickness of 7-20 nm (see the machine translation, pg. 5, paras. 7-9), which is with the claimed range.
With respect to claims 5 and 14, Xu teaches silica magnetic microspheres (see machine translation, pg. 2, para. 5 of Summary of the invention).
With respect to claims 6 and 15, Xu teaches the main body of the microsphere is 2-60 µm (see machine translation, pg. 2, para. 4 of Summary of the invention) which is within the claimed diameter range.
With respect to claims 7 and 16, Xu teaches the inside is modified with magnetism (see machine translation, pg. 2, paras. 4-5 of Summary of the invention). Xu also teaches the separation and detection of microsphere can be achieved by magnetic adsorption (see machine translation, pg. 4, bottom of para. 4).
With respect to claims 8 and 17, Xu teaches polystyrene magnetic microspheres and silica magnetic microspheres (see machine translation, pg. 2, para. 5 of Summary of the invention).
With respect to claim 10, Xu teaches the microspheres are used to absorb and separate single virus particles (see pg. 5, Example (3) three).
Response to Arguments
Applicant’s arguments filed 03/06/2026 have been considered but are moot because Applicant’s amendments necessitated a new ground of rejection. Although the rejection has been modified in view of the amendments, certain arguments related to Xu will be addressed.
Applicant argues on page 10 that Xu does not disclose dividing the microsphere surface into a plurality of circumferential annular subzones. Applicant argues on page 11 that Xu’s cited passages do not disclose this particular chip-based workflow with a micropore chip, washing, and transferring the microsphere to another micropores, as claimed.
With respect to claims 1-8, the arguments are not found persuasive for the following reasons. As stated above, in the obviousness rejection, Xu does not explicitly teach the amended limitations. However, Xu does teach that each subzone has boundaries such that a single virus particle is adsorbed on the functionalized spots, and the surface of the microsphere body does not adsorb biological particles and the surface is modified with fluorescence or quantum dots and the inside is modified with magnetic (see machine translation, pg. 4, para. 4). Thus, Xu provides a blueprint of the claimed microsphere body.
With respect to claims 9-17, the arguments are not found persuasive for the following reasons. As stated above, Xu does not explicitly teach washing the chip multiple times with PBS or deionized water in claim 9. However, Xu does teach an application of microspheres with functionalized spots on the surface and the microspheres are used for adsorption and separation of biological active particles wherein the an microsphere array with functionalized spots on the surface on the first chip containing the micropore array and adding a solution containing biologically active particles to the surface of the first chip, and the biologically active particles are adsorbed on the functionalized spots of the microspheres (see machine translation of Summary of the invention, page 3, paras. 16-20). Xu further teaches washing off excess biologically active particles, cover the second chip, and transfer the microspheres with adsorbed biologically active particles to the second chip by magnetic adsorption (see machine translation of Summary of the invention, page 4, paras. 16-20). Thus, Xu provides a blueprint for using the microsphere body as claimed.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/N.P.N/Examiner, Art Unit 1678
/SHAFIQUL HAQ/Primary Examiner, Art Unit 1678
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