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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/22/26 has been entered.
Election/Restrictions
The Examiner notes claims 31-36 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. See Paragraphs 2-4 of the Final Rejection mailed 08/20/26.
Response to Arguments
Applicant’s arguments, filed 12/22/25, with respect to the rejection(s) of claims 23-30 under 35 U.S.C. 103 as being unpatentable over Fung et al. (US 6,221,655) in view of Nova et al. (US 2007/0248957), and further in view of Chen et al. (US 2009/0007937) and Glezer et al. (US 2007/0202538) have been fully considered and are persuasive. Applicant has amended claim 23 to recite a collar that is within the bead retaining tube and slopes towards the one or more exit openings, wherein the collar is dimensioned to support the one or more beads above the one or more exit openings and prevent the one or more beads from blocking the one or more exit openings” and then argued this feature is not taught by the cited prior art, Glezer. See pages 5-6 of Applicant’s Remarks. See also the Interview Summary on 12/18/25. The Examiner agrees; therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made below.
Inventorship
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 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 (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 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.
Claims 23-30 are rejected under 35 U.S.C. 103 as being unpatentable over Fung et al. (US 6,221,655) in view of Nova et al. (US 2007/0248957), and further in view of Chen et al. (US 2009/0007937) and Knight (US 2014/0272989).
Regarding claims 23, 24 and 30 - Fung teaches a kit for isolating compounds. As shown in Figures 1-4, Fung teaches a centrifuge tube (2) and a bead retaining tube (1). The bead retaining tube (1) has a diameter with dimensions suitable for fitting into a top portion of the centrifuge tube without touching the bottom of the centrifuge tube and includes a filter frit with a plurality of exit openings that retains a solid support bead while allowing other material to pass. The bead retaining tube (1) includes a lip (lip 10) that engages with the entrance of the centrifuge tube (2). See Figure 1 and column 5, lines 14-19. Fung teaches a purification kit which includes the solid binding matrix in column 6, line 65 - column 7, line 7. Fung discloses elution, washing and lysis buffers in column 7, lines 1-47 and the Examples. Fung does not teach a spherical bead diameter of at least 1 mm and does not teach an exit opening dimension of 0.5 mm for the bead retaining tube. Fung also does not teach at least one structure for supporting the one or more beads above the one or more exit openings.
Nova teaches solid support materials such as beads that contain remotely addressable and programmable recording devices. The solid supports may be used in the purification of target materials such as proteins and nucleic acid. The memory devices on the support beads record data related to the compounds on the bead. See Abstract; Figures 1-8 and 18; and Paragraphs 0016-0057 and 0081-0142, especially Paras 0081-0084. Nova teaches spherical glass or ceramic beads of up to 10 mm but preferably 1, 2, or 5-10 mm in Paragraphs 0032, 0081, 0148, 0149, and 0152. In Paragraph 0152, Nova teaches larger particles such as their particles provide ease of handling. In Paragraphs 0046, 0265, 0346 and 0386, Nova teaches their particles may be used as a support for nucleic acid synthesis. The Examiner submits it would have been obvious to one of ordinary skill in the art at the time of the effective date of the invention to combine the solid support beads with nucleic acid having a size of up 10 mm and memory from Nova with the device of Fung. One of ordinary skill in the art at the time of the effective date of the invention would add the support beads to Fung in order to provide a trackable solid support having a memory element that contains information about the support and compound on the support as taught by Nova. One of ordinary skill in the art at the time would use the bead sizes recited Nova in order to provide a larger surface area for the support and for ease of handling as taught by Nova. The combination of Fung and Nova does not teach an exit opening dimension of 0.5 mm for the bead retaining tube. The combination of Fung and Nova also does not teach at least one structure for supporting the one or more beads above the exit openings.
Chen teaches an apparatus and method for washing biological material. The portions of the device most relevant to the instant claims are best shown in Figures 1, 3B, 5A, 5B and described in Paragraphs 0003-0012 and 0021-0038. As shown in the Figures, the device includes a tubular inner container (sleeve 20) having a bottom with openings (filter structure 32) that is inserted into and an outer container (sleeve 10). The inner sleeve contains biological material to be washed disposed on the filter structure. The Examiner considers the inner container (sleeve 20) to be analogous to the bead retaining tube of the instant claims. In Paragraphs 0008 and 0031, Chen teaches a range of 0.15 mm to 3 mm for the openings and further teaches that the opening size may be made larger to accommodate larger amounts of biological material held by the filter structure. The Examiner submits it would have been obvious to one of ordinary skill in the art at the time of the effective date of the invention to combine the exit opening size from Chen with the combined device of Fung and Nova. Fung is silent as to the size of the opening. One of ordinary skill in the art at the time would have added the opening diameter from Chen with Fung and Nova in order to allow for larger size particles and material to be held in the tube without blocking or clogging the openings as taught by Chen. The combination of Fung, Nova and Chen does not teach a bead retaining structure in the bead retaining tube as currently recited in the claim.
Knight teaches a tray having a plurality of reagent wells containing lyophilized reagents. The embodiments of the device most relevant to the instant claims are shown in Figures 8 and 9C-9E; and described in Paragraphs 0064-0084. As shown in the cited Figures, the device of Knight includes a plurality of wells that may include an annular ridge element (800) that tapers towards the bottom of the well or finger collar (860) which slope towards the bottom of the well for containing a lyophilized bead (495) above the ridge before adding reagents. See Paragraphs 0070-0072. The Examiner submits it would have been obvious to one of ordinary skill in the art at the time of the effective date of the invention to combine the ridge or collar feature from Knight with the combined device of Fung, Nova, and Chen. One of ordinary skill in the art at the time would add the ridge or collar feature to the combined device of Fung, Nova, and Chen, in order to store a lyophilized reagent bead in the well before addition of liquids as taught by Knight.
Regarding claim 24 - Fung discloses bead retaining tube (1) includes a lip (flange or lip 10) that engages with the entrance of the centrifuge tube (2) in Figure 1 and column 5, lines 14-19.
Regarding claim 27 - Nova discloses support beads for use in scintillation assays that are coated with a charged compound in Paragraph 0302.
Regarding claims 25, 26, 28 and 29 - Nova teaches containers for use in chemical synthesis and screening having a volume of 5 ml or less in Paragraph 0084. Nova teaches spherical glass or ceramic beads of up to 10 mm but preferably 1, 2, or 5-10 mm in Paragraphs 0032, 0081, 0148, 0149, and 0152, but Fung and Nova are silent with respect to the specific combination of number and size of beads. The Examiner submits it would have been obvious to one of ordinary skill in the art at the time of the effective date of the invention to determine the optimal size and number of beads required for a given separation procedure or kit through routine experimentation. See MPEP 2144.05, Section II, Routine Optimization.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DWAYNE K HANDY whose telephone number is (571)272-1259. The examiner can normally be reached M-F 10AM-7PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi can be reached at 571-270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DWAYNE K HANDY/Examiner, Art Unit 1798 February 21, 2026
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798