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/Restrictions
Applicant’s election without traverse of Group I, claims 1-4, 6-8, 10-12, 15, 17-18, and 20 in the reply filed on 3/20/2026 is acknowledged. The arguments in Remarks (page 5-7) are not persuasive because the concentration of each ingredients in the preservation solution taught by the cited prior art references as follows can be routinely optimized by one of ordinary skill in the art.
In response to the species election, applicant elected a magnesium chloride salt solution with traverse. Thus, claim 15 not reading on the elected species is withdrawn with traverse.
Claims 13-14 are further withdrawn from consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected method invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 3/20/2026.
Claim Status
Claims 1-4, 6-8, 10-15, 17-18, and 20 are pending.
Claims 5, 9, 16, and 19 are cancelled.
Claims 13-15 are withdrawn as being directed to a non-elected invention, the election having been made with traverse on 3/20/2026.
Claims 1-4, 6-8, 10-12, 17-18, and 20 have been examined.
Priority
This application is a 371 of PCT/CN2022/103699 filed on 07/04/2022 and claiming foreign priority of CHINA 202110857803.9 filed on 07/28/2021.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 2/5/2024, 2/26/2024, 8/5/2025, and 12/8/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has 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 1-2, 11-12, and 20 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 1 is unclear with respect to the last word of “inclusive” in the paragraphs of “a volume percentage of the surfactant…”, “a molar concentration of the water-soluble salt…”, and a volume percentage of the bacteriostatic agent…”. If the word “inclusive” is interpreted as an open-ended word of including or comprising, the amounts of each ingredients can be outside the dosage ranges in claim 1. Alternatively, claim 1 can be interpreted as each ingredients are within the ranges. MPEP 2173.02 (I) states “During examination, after applying the broadest reasonable interpretation to the claim, if the metes and bounds of the claimed invention are not clear, the claim is indefinite and should be rejected. Zletz, 893 F.2d at 322, 13 USPQ2d at 1322. For example, if the language of a claim, given its broadest reasonable interpretation, is such that a person of ordinary skill in the relevant art would read it with more than one reasonable interpretation, then a rejection under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph is appropriate.”
Claim 2 is unclear with respect to the phrase “a plurality of combinations of the divalent salts”. Because the individual water-soluble divalent salt is not distinctly defined in claim 2, the metes and bounds of the phrase is indefinite.
Similarly, the word “inclusive” in the last line of claims 11-12, and 20 is unclear. If the word “inclusive” is interpreted as an open-ended word of including or comprising, the amounts of each ingredients can be outside the dosage ranges in the claims. Alternatively, the claims 1 can be interpreted as each ingredients are within the ranges in the claims.
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.
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.
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.
Claims 1-4, 6-8, 10-12, 17-18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Sun et al. (CN 109735532 A including English translation, previously cited 1/22/2026) in view of Koh et al. (US 10,786,811 B1), Sehgal (US 2015/0056604 A1) and Power et al. (US 2012/0028929 A1).
Claim 1 is drawn to a solution of magnesium beads, comprising:
Comprising 0.5% to 5% of surfactant in volume percentage
Comprising l mol/L to 3 mol/L of a water-soluble salt in molar concentration
Comprising 0.l % to 0.5 % bacteriostatic agent in volume percentage
Sun et al. teach a solution of magnetic beads comprising water-soluble salts of sodium chloride and/or magnesium chloride, a surfactant of polysorbas20, and water (p14, Summary of the invention, para 2).
With respect to the limitation (i), Sun et al. teach the percent by volume of the surfactant as polysorbate 20 is 0-5% (p15, line 6).
With respect to the limitation (ii), Sun et al. teach concentration of the sodium chloride salt in bead solution is preferred to be l mol/L to 3 mol/L (p15, line 1) and a molar concentration of the divalent magnesium chloride salt at 0.3 mol/L -1 mol/L (p15, line 2).
Sun et al. did not specify the solution of magnetic beads further comprising a bacteriostatic agent.
Similarly, Koh et al. teach common reagents of a surfactant (such as a cationic, anionic, nonionic, or zwitterionic surfactants) and an antibiotic (col 27, line 18-20) are used together with magnetic particles (col 27, line 30-31) known in the art. Sehgal et al. teach the use of broad spectrum anti-microbial agents comprising one or more antibiotics of vancomycin, tetracycline, chloramphenicol, and functionally equivalent antibiotics in a preservation composition [0117] to prevent bacterial contamination [0005]. Because (a) Koh et al. teach surfactant and an antibiotic (col 27, line 18-20) are used together with magnetic particles (col 27, line 30-31) and (b) Sehgal et al. teach the use of broad spectrum antibiotics comprising one or more vancomycin, tetracycline, chloramphenicol, and functionally equivalent antibiotics in a preservation composition [0117] to prevent bacterial contamination [0005]. Power et al. is further cited to show tetracyclines as a group of broad-spectrum antibiotics able to treat bacterial infection [0001]. Power et al. further suggest the effective amount of tetracycline or its analogs can be optimized from about 0.0025% to about 1% [0009], reading on the limitation (iii).
One of ordinary skill in the art before the effective filing date of this invention would have found it obvious to combine (i) Sun et al. with (ii) Koh et al.in view of Sehgal et al. and Power et al. because (a) Sun et al. teach a solution of magnetic beads comprising water-soluble salts and a surfactant and water (p14, Summary of the invention, para 2), (b) Koh et al. teach common reagents of a surfactant (such as a cationic, anionic, nonionic, or zwitterionic surfactants) and an antibiotic (col 27, line 18-20) are used together with magnetic particles (col 27, line 30-31) known in the art, (c) Sehgal et al. teach the use of broad spectrum antibiotics comprising one or more vancomycin, tetracycline, chloramphenicol, and functionally equivalent antibiotics in a preservation composition [0117] to prevent bacterial contamination [0005], and (d) Power et al. is further cited to show tetracyclines as a group of broad-spectrum antibiotics able to treat bacterial infection [0001] and suggest the effective amount of tetracycline or its analogs can be optimized from about 0.0025% to about 1% [0009]. The combination would have reasonable expectation of success because a broad-spectrum antibiotic of tetracycline in a preservation solution is expected to prevent bacterial contamination of magnetic particles.
With respect to claims 2-4, Sun et al. teach a molar concentration of the divalent magnesium chloride salt at 0.3 mol/L-1 mol/L (p15, line 2) in the solution containing magnetic beads.
With respect to claims 6-8, Koh et al. teach common reagents of a surfactant (such as a cationic, anionic, nonionic, or zwitterionic surfactants) and an antibiotic (col 27, line 18-20) are used together with magnetic particles (col 27, line 30-31). Sehgal et al. teach the use of broad spectrum anti-microbial agents comprising one or more antibiotics of vancomycin, tetracycline, chloramphenicol, and functionally equivalent antibiotics in a preservation composition [0117] to prevent bacterial contamination [0005]. Power et al. is further cited to show tetracyclines as a group of broad-spectrum antibiotics able to treat bacterial infection [0001]. Power et al. further suggest the effective amount of tetracycline or its analogs can be optimized from about 0.0025% to about 1% [0009].
With respect to claims 10-11, Sun et al. teach the solution containing magnetic beads further containing ethylenediamine tetra-acetic acid (EDTA) from 0.1 mmol/L to 10 mmol/L (p15, line 3).
With respect to claim 12, Sun et al. teach the solution containing magnetic beads with pH value 7.5 – 8.5 (p15, line 4).
With respect to claims 17-18, Sun et al. teach the solution containing magnetic beads further comprising a surfactant of polysorbate 20 (p15, line 6).
With respect to claim 20, Sun et al. teach the molar concentration of a buffer agent is in a range of 0.1 mmol/L to 10 mmol/L (p15, line 4).
Double Patenting
Claims 1-4, 6-8, 10-12, 17-18, and 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, and 8 of copending Application No. 17/778,852 (the ‘852 application) in view of Sun et al. (CN 109735532 A including English translation, previously cited 1/22/2026) in view of Koh et al. (US 10,786,811 B1), Sehgal (US 2015/0056604 A1) and Power et al. (US 2012/0028929 A1).
Claim 1 of the ‘852 application disclosed a magnetic bead suspension reagent comprising magnetic beads and surfactant.
Claims 5 and 8 of the ‘852 application disclosed the magnetic bead suspension reagent further comprising ionic salt selected from NaCl and Mg Cl2.
Claims 1, 5, and 8 of the ‘852 application do not specify the reagent further comprising a bacteriostatic agent.
The relevancy of Sun et al. in view of Koh et al., Sehgal and Power et al. as applied to claims 1-4, 6-8, 10-12, 17-18, and 20 not repeated here.
Because Koh et al. in view of Sehgal and Power et al. teach beneficial addition of an antibiotic as a bacteriostatic agent to prevent bacterial contamination of magnetic beads, one of ordinary skill in the art would have found it obvious to combine claims 1, 5, and 8 of the ‘852 application with Koh et al. in view of Sehgal and Power et al.
Thus, claims 1, 5, and 8 of the ‘852 application in view of Koh et al., Sehgal and Power et al. are obvious to the instant claims 1-4, 6-8, 10-12, 17-18, and 20.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claim is allowed.
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/J.L/Examiner, Art Unit 1658
17-April-2026
/Melissa L Fisher/ Supervisory Patent Examiner, Art Unit 1658
