DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. 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
2. Applicant's election with traverse of claims 1-8 and 10-15 in the reply filed on 01/20/2026 is acknowledged. The traversal is on the ground(s) that the teachings of Nishi does not teach the amended claim 1. Applicant’s arguments are based on the presently amended claims having a technical feature not taught by the references cited in the restriction requirement set forth in the office action mailed 11/21/25. However, the restriction requirement was properly made with respect to the claims presented at the time of the previous office action (i.e., the claims as originally presented) and Applicant has not presented any arguments directed to the original claims. Also, even with respect to the newly amended claims, the amended claims do not make a contribution over the prior art (i.e., Groups I and II still lack the same or corresponding special technical feature) because the groups do not make a contribution over the prior art, namely Yao (WO 2021086550 A1) as set forth in paragraph 12 and Yao (WO 2021086550 A1) further in view of Mathus (US 20080286157 A1) as set forth in paragraph 14 below. Therefore, the common feature between the groups does not provide a contribution over the prior art, and, thus cannot be a special technical feature. Therefore, Groups I and Il do not relate to a single inventive concept under PCT Rule 13.1.
The requirement is still deemed proper and is therefore made FINAL.
3. Claim 9 is withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected election, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 01/20/2026.
4. Claims 1-8 and 10-15 are being examined herein.
Priority
5. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
6. The information disclosure statement (IDS) submitted on 04/20/2023 is being considered by the examiner.
Claim Interpretation
7. The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
8. The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
9. The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
10. Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Such limitation includes,
“biasing means configured to create a tension in the mixing chamber” in claim 6, lines 1-2.
In this instant case, the corresponding structure for
the “biasing means configured to create a tension in the mixing chamber” is a spring (para. 0019) and equivalents thereof.
Claim Rejections - 35 USC § 102
11. 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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
12. Claims 1-3 and 6 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Yao et al. (WO 2021086550 A1).
Regarding claim 1, Yao teaches a mixer (Fig. 1C), comprising:
a mixing chamber (pipette 132 and pipette tip 134) configured to hold a liquid sample (Fig. 1C and para. 007, aspirate liquid), the mixing chamber including
a suspended elongate rigid tube section (the section of 132 that is in contact with 138)(Fig. 1C and para. 0038, body 138 is a rigid structure supporting 132, and thus the section of 132 that is supported by 138 is a rigid tube section) having a top end and an open bottom end (Fig. 1C), and
a flexible tube section (the section of 132 that is not in contact by 138)(less rigid since not restricted/support by body 138 and thus more flexible) extending downwards from the open bottom end (Fig. 1); and
a vibration motor (vibration inducer 140) mechanically coupled to the mixing chamber at the top end of the suspended elongate rigid tube section (Fig. 1C and para. 0039), the vibration motor configured to induce an oscillatory motion of the mixing chamber (para. 0025) to induce mixing of the liquid sample held in the mixing chamber based on the vibration motor being actuated (the liquid sample is not positively recited. In the case when there is a sample in pipette tip 134, the vibration of the pipette tip would let to motion of the sample and consequently causes mixing of the sample), wherein the mixer is configured to transmit vibrations generated by the vibration motor to the mixing chamber through the top end of the suspended elongate rigid tube section (Fig. 1C and para. 0039).
Regarding claim 2, Yao teaches all of the elements of the current invention as stated above with respect to claim 1. Yao further, wherein the vibration motor and the mixing chamber are mutually configured to cause an oscillating frequency of the vibration motor to be equal to a resonant frequency of the mixer (para. 0043, vibration inducer includes an active tuned absorber including a spring to provide oscillation at a natural frequency, which is a resonant frequency).
Regarding claim 3, Yao teaches all of the elements of the current invention as stated above with respect to claim 2. Yao further teaches wherein the resonant frequency of the mixer is tuned to be equal to the oscillating frequency of the vibration motor based on a length of the flexible tube section (para. 0043, the resonant frequency of mixer is tuned based the entire structure of the mixer, and thus the effect based on the length of the flexible tube section is included in oscillating at a natural frequency).
Regarding claim 6, Yao teaches all of the elements of the current invention as stated above with respect to claim 1. Yao further comprising a biasing means (spring) configured to create a tension in the mixing chamber (para. 0043).
Claim Rejections - 35 USC § 103
13. 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.
14. Claims 1-6, 8, 10-15 are rejected under 35 U.S.C. 103 as being unpatentable over Yao et al. (WO 2021086550 A1) in view of Mathus et al. (US 20080286157 A1)
Regarding claim 1, Yao teaches a mixer (Fig. 1C or alternatively Fig. 1D, which has space 138S between body 138 and pipette 132, para. 0041), comprising:
a mixing chamber (pipette 132 and pipette tip 134) configured to hold a liquid sample (Fig. 1C), the mixing chamber including
a suspended elongate rigid tube section (132) having a top end and an open bottom end (Fig. 1C), and
a second tube section (134) extending downwards from the open bottom end (Fig. 1); and
a vibration motor (vibration inducer 140) mechanically coupled to the mixing chamber at the top end of the suspended elongate rigid tube section (Fig. 1C and para. 0039), the vibration motor configured to induce an oscillatory motion of the mixing chamber (para. 0025) to induce mixing of the liquid sample held in the mixing chamber (the liquid sample is not positively recited. In the case when there is a sample in pipette tip 134, the vibration of the pipette tip would lead to motion of the sample and consequently causes mixing of the sample) based on the vibration motor being actuated, wherein the mixer is configured to transmit vibrations generated by the vibration motor to the mixing chamber through the top end of the suspended elongate rigid tube section (Fig. 1 and para. 0039).
Yao teaches the mixing chamber comprises pipette body 132 (rigid tube section) and pipette tip 134 (second tube section), and pipette tip 134 is mounted to pipette body 132 (Fig. 1C).
Yao does not teach the materials of the pipette body 132 and pipette tip 134, and thus does not explicitly teach pipette tip 134 (the second tube section) is a “flexible” tube section relative to the rigid tube section (pipette body).
However, Mathus teaches a pipette comprises a mounting shaft (12) made from machined steel or PEEK (para. 0040). Mathus further teaches a pipette tip is mounted to the mounting shaft (Figs. 1 and 2) and the pipette tip is made from polypropylene (para. 0038).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the materials of pipette body 132 and pipette tip 134 to be machined steel or PEEK and polypropylene, respectively, as taught by Mathus (Mathus, paras. 0038 and 0040) because one of ordinary skill in the art would accordingly have recognized the machined steel or PEEK as the material for pipette body 132 and polypropylene as the material for pipette tip 134 would result in the predictable result of providing the materials for pipette body 132 and pipette tip 134 such that the pipette tip can be mounted on the pipette body.
The teachings of modified Yao would yield the second tube section to be a flexible tube section since polypropylene is flexible relative to machined steel or PEEK.
Regarding claim 2, modified Yao teaches all of the elements of the current invention as stated above with respect to claim 1. Yao further teaches, wherein the vibration motor and the mixing chamber are mutually configured to cause an oscillating frequency of the vibration motor to be equal to a resonant frequency of the mixer (para. 0043, vibration inducer includes an active tuned absorber including a spring to provide oscillation at a natural frequency, which is a resonant frequency).
Regarding claim 3, modified Yao teaches all of the elements of the current invention as stated above with respect to claim 2. Modified Yao teaches, wherein the resonant frequency of the mixer is tuned to be equal to the oscillating frequency of the vibration motor based on a length of the flexible tube section (para. 0043 teaches the vibration motor and mixing chamber oscillates at the resonant frequency. Since pipette tip 134 is part of the mixer, the resonant frequency of the mixer is tuned with the effect of the length of pipette tip 134 included when the vibration motor and mixing chamber oscillate at the resonant frequency. Regarding claim 4, modified Yao teaches all of the elements of the current invention as stated above with respect to claim 1. Modified Yao further teaches wherein the flexible tube section includes a flexible tube (pipette tip 134) that is separate from the suspended elongate rigid tube section and is connected to the open bottom end of the suspended elongate rigid tube section (Fig. 1C).
Regarding claim 5, modified Yao teaches all of the elements of the current invention as stated above with respect to claim 1. Modified Yao further teaches wherein the suspended elongate rigid tube section (132) includes a tapering cross section portion that tapers to the open (Fig. 1C).
Regarding claim 6, modified Yao teaches all of the elements of the current invention as stated above with respect to claim 1. Yao further teaches the mixer further comprising a biasing means (spring) configured to create a tension in the mixing chamber (para. 0043, includes a spring between support body 138 and the pipette assembly 130, and thus create a tension on pipette 132).
Regarding claim 8, modified Yao teaches all of the elements of the current invention as stated above with respect to claim 1.
Yao teaches the use of pipette 132 and pipette 134 to aspirate and dispense liquid samples (paras. 0021-0022)
Yao does not explicitly teach the volume of the pipette tip 134 can hold nor does Yao teach the type (in terms of volume) of tip pipette 132 can accommodate, and thus Yao fails to the mixing chamber has an internal volume configured to hold between around 4 microliters to around 1,000 microliters of the liquid sample.
However, Mathus teaches different pipettors can accommodate pipette tips of different sizes (para. 0012). Mathus further a pipette tip can be 300 microliters (para. 0012).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the pipette tip and pipette taught by Yao to have a pipette tip of a volume of 300 microliters and a pipette that is able to accommodate the pipette tip of 300 microliters taught by Mathus because one of ordinary skill in the art would accordingly have recognized the pipette tip of 300 microliters with the pipette that can accommodate the pipette would result in the predictable result of providing a pipette tip and a pipette that can aspirate and dispense liquid.
The teachings of modified Yao would yield the mixing chamber has an internal volume configured to hold between around 4 microliters to around 1,000 microliters of the liquid sample (modified Yao has a tip can hold 300 microliters, which is within the range).
With regards to the limitation “the liquid sample containing one or more analytes, and at least one reactant including microspheres with a binding agent bonded thereto specific to the one or more analytes,” the liquid sample is not positively recited and thus not a part of the invention. Since the limitation is directed to the liquid sample, the limitation does not further limit the structure of the invention.
Regarding claim 10, modified Yao teaches all of the elements of the current invention as stated above with respect to claim 6. Modified Yao further teaches wherein a resonant frequency of the mixer is tuned to be equal to an oscillating frequency of the vibration motor based on a particular magnitude of the tension in the mixing chamber that is created by the biasing means (para. 0043).
Regarding claim 11, modified Yao teaches all of the elements of the current invention as stated above with respect to claim 1.
Interpreted with the alternative of Fig. 1D
Yao further teaches wherein the vibration motor (140) is configured to drive the mixing chamber in an oscillatory circular motion, based on the vibration motor being actuated (para. 0041, pipette tip 134 vibrated in a circular mode).
Regarding claim 12, modified Yao teaches all of the elements of the current invention as stated above with respect to claim 11. Modified Yao further teaches the mixer further comprising:
a tube mount arm (body 138 and arm 118A), the tube mount arm configured to hold the suspended elongate rigid tube section at a location proximate to the top end of the suspended elongate rigid tube section (Fig. 1C), the tube mount arm including a bushing (body 138) configured to hold the suspended elongate rigid tube section such that the suspended elongate rigid tube section is suspended vertically from the tube mount arm (Fig. 1C),
wherein the flexible tube section (134) is secured to a fixed fluid port (opening 344)(Fig. 3 and para. 0049, pipette tip 134 is secured to opening 344 until opening 344 widens), and
wherein the mixer is configured to transmit the vibrations generated by the vibration motor to the mixing chamber through the top end of the suspended elongate rigid tube section to cause the mixing chamber to oscillate (para. 0039) such that the mixing chamber has fixed nodal points where the suspended elongate rigid tube section connects with and is held by the bushing and where the flexible tube section is secured to the fixed fluid port (vibration of the tube section with two fixed ends would result in nodal points).
Regarding claim 13, modified Yao teaches all of the elements of the current invention as stated above with respect to claim 11. Yao further wherein the vibration motor is configured to drive the mixing chamber in the oscillatory circular motion (para. 0041) to induce a vortex mixing effect on the liquid sample held within the mixing chamber (the liquid sample is not positively recited. In the scenario where there is a liquid sample in pipette tip 134, the motor induced circular motion would induce vortex mixing effect).
Regarding claim 14, modified Yao teaches all of the elements of the current invention as stated above with respect to claim 1.
Interpreted with the alternative of Fig. 1D
Yao further teaches wherein the vibration motor is an eccentric rotating mass motor (para. 0043, “a mass, such as the shaft 140A in FIG. ID or a weight, may tune the system to a natural frequency or vibration”).
Regarding claim 15, modified Yao teaches all of the elements of the current invention as stated above with respect to claim 1. Modified Yao further teaches wherein the vibration motor is configured to generate the vibrations at a same frequency as a resonant oscillation frequency of the mixer (para. 0043).
15. Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Yao et al. (WO 2021086550 A1) in view of Mathus et al. (US 20080286157 A1) as applied to claim 1 and further in view of Tajima (US 6100079 A).
Regarding claim 7, modified Yao further teaches all of the elements of the current invention as stated above with respect to claim 1.
Yao teaches an apparatus comprising a pipette system including pipette 132, pipette tip 134 and vibration inducer 140. Yao further teaches the pipette system can be positioned to aspirate and dispense liquid from/ into reagent wells 104 and sample vessels 114 (paras. 0028, 0029 and 0034). Yao teaches that the reagent wells are cover with cover 122 to prevent leakage (para. 0031). Yao further teaches vibration inducer 140 cause pipette tip 134 to vibrate to help prevent the common problem of pipette tip 134 being stuck the cover 122 when pipette tip 134 is being retracted (para. 0024).
Yao does not teach the apparatus further comprising a magnetic separation mechanism configured to selectively generate a magnetic field within at least a portion of an internal volume of the mixing chamber.
However, Tajima teaches an apparatus comprising an automated pipette system comprising pipette nozzle and a pipette tip for separating biopolymers from a biological sample milieu using the pipette tip (abstract and col. 6, lns. 43-48). Tajima further teaches the apparatus further comprising a magnetic separation mechanism (a magnet M being placed against the pipette tip or being removed from the pipette tips) configured to selectively generate a magnetic field within at least a portion of an internal volume of the mixing chamber (pipette tip).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the apparatus taught by modified Yao with a magnet that can be placed against or removed from the pipette tip taught by Tajima in order to separate biopolymers for PCR detection with a pipetting apparatus that configured to prevent pipette tip being stuck to a reagent cover with a reasonable expectation of success (Tajima, abstract, Fig. 2 and Yao, para. 0024) (MPEP 2143)(I)(G).
Conclusion
16. Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAY CHIU whose telephone number is (571)272-1054. The examiner can normally be reached 9 am - 5 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel can be reached at 571-270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.L.C./Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758