FINAL 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 .
Response to Arguments
Applicant's arguments filed 10 July 2025 have been fully considered but they are not persuasive.
In response to Applicant’s argument that “Berthier I lacks any teaching that the alleged counterweight 26A is monolithic with the alleged tube retainer 26” (page 8, Remarks), the examiner respectfully disagrees. Berthier depicts a rotor 24 that includes the opening or tube retainer region 26 and the opposite counterbalance region 26A as part of the rotor body (see Fig. 1D). Since the opening or tube retainer 26 and counterbalance 26A are both part of the same rotor body 24, the counterweight is integral/monolithic with the tube retainer as claimed.
Furthermore, making structures integral is considered a predictable design choice. In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965) (A claim to a fluid transporting vehicle was rejected as obvious over a prior art reference which differed from the prior art in claiming a brake drum integral with a clamping means, whereas the brake disc and clamp of the prior art comprise several parts rigidly secured together as a single unit. The court affirmed the rejection holding, among other reasons, "that the use of a one piece construction instead of the structure disclosed in [the prior art] would be merely a matter of obvious engineering choice.").
In response to Applicant’s response that “as modified with the alleged internal top surface at the top end of the housing 12, the components of the centrifuge 16 and rotor 24 are still below the top end. Thus the modified assembly would fail to provide ‘exactly on tube retainer adapted to manually, removably hold exactly a single, fluid sample tube at a fixed predetermined angle from the rotor plane and above the internal top surface”’ (pages 9 and 10, Remarks), the examiner respectfully disagrees. Applicant’s argument depends on the premise that Zhou’s “internal top surface” must correspond to the topmost end of Berthier’s housing (surface of lid 20, Fig. 1D), but this is not required by the claim language. The claim requires an enclosure comprising internally an internal top surface, with the rotor and the power source below it, and a rotor plane above it. This reads on an internal partition plate upper surface of a bottom compartment, such as Zhou’s top surface of cylindrical shell 3. Zhou is relied upon for the structural arrangement in which a motor and power source are disposed in a lower base region and a turntable disposed above an internal top surface of the lower base region. The Office action does not rely on Zhou for Berthier’s lid opening structure.
In response to Applicant’s argument that “somehow moving all the components of Berthier above the top end of housing 12 as alleged (but for which the Office action has provided no motivation or teaching to support such a change) would frustrate the purpose of Berthier” (page 10, Remarks), the examiner respectfully disagrees. There is no requirement to move Berthier’s rotor above the top end of the housing. Applicant assumes the “internal top surface” must be the housing cover’s top surface. Since this is not required, the modification can be implemented by providing a base section (with an internal top surface) within Berthier’s housing such that the motor and power source are enclosed below that internal surface while the rotor plane is above it.
In response to Applicant’s argument that “[t]here is no teaching or suggestion that Zhou meets ‘the regulations of biological sample transportation set forth in UN Recommendation 3733 and International Air Transport Association Rule 3.6.2’ as required by Berthier I. This is not attorney argument but rather an express requirement of Berthier I. Applicant invites the Office Action to cite to a portion of Zhou somehow meeting these requirements set forth by Berthier I” (page 11, Remarks), the examiner notes that UN Recommendation 3733 and International Air Transport Association Rule 3.6.2 deal with transport of biological substances, and do not define or require any specific centrifuge internal configuration. The fact that Zhou does not address these shipping regulations does not mean the combined teachings would render the modified device non-compliant with regulations. Thus, the shipping regulations themselves do not teach away from the modification with Zhou.
The rejections over Berthier in view of Zhou and other applied art of record are deemed valid and are maintained.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Drawings
The drawings were received on 13 April 2021. These drawings are acceptable.
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 1, 3, 6-10, 12-14, and 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over Berthier et al. (U.S. Patent No. 11,673,133, hereinafter Berthier) in view of CN 209506225 (Zhou et al., hereinafter Zhou), and further in view of Howell (U.S. Patent No. 5,551,941).
Regarding claim 1, Berthier discloses a centrifuge (centrifuge system 10, Fig. 1D) comprising: an enclosure (housing 12, Fig. 1D), comprising internally: a motor (25, Fig. 1D) with a motor shaft (see annotated Fig. 1D below) defining a rotation axis; wherein the centrifuge further comprises: a lid (20, Fig. 1D) with a hinge attached to the enclosure (see Fig. 1A); a rotor (24, Fig. 1D) comprising: a rotor plane, normal to the rotation axis; a motor attachment hub (see annotated Fig. 1D), adapted to be attached to the motor shaft; exactly one tube retainer (opening 26, Fig. 1D) adapted to manually, removably hold exactly a single, fluid sample tube (tube 36, Fig. 3B) at a fixed, predetermined angle from the rotor plane (rotor opening 26 and counterweight 26A are angled in Fig. 1D); a counterweight (counterbalance 26A, Fig. 1D) adapted to counterbalance the rotor when rotating with the single, fluid sample tube, wherein the counterweight is monolithic with the tube retainer (tube retainer 26 and counter weight 26A are both part of the same rotor body 24, Fig. 1D); and an open, central portion (see annotated Fig. 1D) adapted to receive the single, fluid sample tube into the single tube retainer, but does not disclose an internal top surface, wherein the motor is below the internal top surface, and the rotor plane above the internal top surface, wherein the fixed predetermined angle from the rotor plane is between 0 and 60 degrees, inclusive.
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Zhou discloses an enclosure (cylindrical shell 3 and cover plate 15, Fig. 1), comprising internally: an internal top surface (top surface of cylindrical shell 3, Fig. 1, 2 and 3), wherein the motor (first motor 23, Fig. 2) and the power source (lithium battery pack 22, Fig. 2) are below the internal top surface, and the rotor plane (cylindrical turntable 7, Fig. 1) is above the internal top surface (top surface of cylindrical shell 3, Fig. 1, 2 and 3). It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to have provided the centrifuge of Berthier with the base with an internal top surface as taught by Zhou so that the motor and power source are below the internal top surface and enclosed within the base, and the rotor plane and tube retainer are above the internal top surface for the purpose of compact structure and small occupied space (Abstract, Zhou), as well as to isolate the process chamber from the motor and power source to prevent cross-contamination and to provide cleanliness and ease of maintenance (page 2 lines 17-20 of machine translation, Zhou). The substitution of the motor and the power source configuration of Berthier with the configuration where the motor and power source are in an enclosed base as taught by Zhou is no more than the simple substitution of one known element for another or the application of a known technique to a piece of prior art ready for improvement. KSR Int’l Co. v. Teleflex Inc., 127 S.Ct. 1727, 1740-41 (2007).
The combination of Berthier and Zhou does not explicitly teach wherein the fixed predetermined angel from the rotor plane is between 0 and 60 degrees, inclusive.
Howell discloses analogous art related to a fixed angle centrifuge rotor, wherein the fixed predetermined angel from the rotor plane is between 0 and 60 degrees, inclusive (fixed angle of 45° with respect to the central portion 32C, i.e., the axis of rotation, col. 5 lines 45-59, Fig. 3). It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to have provided the centrifuge of the combination of Berthier and Zhou with the fixed angle as taught by Howell for the purpose of separating a liquid sample, such as a sample of a body liquid, prior to analysis (col. 1 lines 19-23, Howell).
Regarding claim 3, the combination of Berthier, Zhou, and Howell discloses wherein the centrifuge is free of user controls and free of user displays (col. 7 lines 1-12 and 61-67, Berthier) and is free of attached wires (col. 8 lines 41-50, Berthier).
Regarding claim 6, the combination of Berthier, Zhou, and Howell discloses the centrifuge starts rotation of the rotor automatically when the lid is closed; and wherein the rotation timer starts automatically when the lid is closed (col. 7 lines 1-11, Berthier).
Regarding claim 7, the combination of Berthier, Zhou, and Howell discloses wherein: the centrifuge stops rotation of the rotor automatically the earlier of: (i) when the rotation timer expires, or, (ii) when the lid opened (claim 1, Berthier).
Regarding claim 8, the combination of Berthier, Zhou, and Howell discloses the tube retainer further comprises an upper portion and a lower portion; wherein the one or more support arms connect to the upper portion and the motor attachment hub connects to the lower portion (Fig. 1D, the monolithic rotor 24 includes the motor attachment hub, the support arms, and the upper and lower portion of the tube retainer, Berthier).
Regarding claim 9, the combination of Berthier, Zhou, and Howell discloses wherein: the rotor (24, Fig. 1D, Berthier) further comprises: a curved or angled counterweight support structure mechanically connecting the motor attachment hub to the counterweight (counterbalance 26A, Fig. 1D, Berthier) wherein a shape of the counterweight support structure is free of interference with the open central portion (Fig. 1D, Berthier).
Regarding claim 10, the combination of Berthier, Zhou, and Howell discloses wherein the counterweight (counterbalance 26A, Fig. 1D, Berthier) comprises a leading edge and a trailing edge, wherein the leading edge and trailing edges are adapted, along with the remainder of the counterweight, to minimize air resistance when the rotor is spinning (counterbalance 26A has rounded edges, Fig. 1C and 1D, Berthier).
Regarding claim 12, the combination of Berthier, Zhou, and Howell discloses a vibration damping motor mount 31 (Fig. 1D, Berthier).
Regarding claim 13, Berthier discloses a method of use of a centrifuge wherein: discloses a centrifuge (centrifuge system 10, Fig. 1D) comprising: an enclosure (housing 12, Fig. 1D), comprising internally: a motor (25, Fig. 1D) with a motor shaft (as shown in annotated Fig. 1D above) aligned on a rotation axis; wherein the centrifuge further comprises: a lid (20, Fig. 1D) with a hinge attached to the enclosure (Fig. 1A); a rotor (24, Fig. 1D) comprising: a rotor plane, normal to the rotation axis; a motor attachment hub (see annotated Fig. 1D), adapted to be attached to the motor shaft; exactly one tube retainer (opening 26, Fig. 1D) adapted to manually, removably hold exactly a single, fluid sample tube (tube 36, Fig. 3B) at a fixed, predetermined angle from the rotor plane (rotor opening 26 and counterweight 26A are angled in Fig. 1D); a counterweight (counterbalance 26A, Fig. 1D) adapted to counterbalance the rotor when rotating with the single, fluid sample tube, wherein the counter weight is monolithic with the exactly one tube retainer (tube retainer 26 and counter weight 26A are both part of the same rotor body 24, Fig. 1D); and an open, central portion adapted to receive the single, fluid sample tube into the single tube retainer (opening 26, Fig. 1D); comprising the steps: placing manually a sample tube comprising a sample fluid into the rotor; closing manually the lid; spinning automatically the rotor; and removing manually the sample tube after the centrifuge has stopped spinning (col. 7 lines 67), but does not disclose an internal top surface, wherein the motor is below the internal top surface, and the rotor plane above the internal top surface, wherein the fixed predetermined angle from the rotor plane is between 0 and 60.
Zhou discloses an enclosure (cylindrical shell 3 and cover plate 15, Fig. 1), comprising internally: an internal top surface (top surface of cylindrical shell 3, Fig. 1, 2 and 3), wherein the motor (first motor 23, Fig. 2) and the power source (lithium battery pack 22, Fig. 2) are below the internal top surface, and the rotor plane (cylindrical turntable 7, Fig. 1) is above the internal top surface (top surface of cylindrical shell 3, Fig. 1, 2 and 3). It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to have provided the method of Berthier with the base with an internal top surface as taught by Zhou so that the motor and power source are below the internal top surface and enclosed within the base, and the rotor plane and tube retainer are above the internal top surface for the purpose of compact structure and small occupied space (Abstract, Zhou), as well as to isolate the process chamber from the motor and power source to prevent cross-contamination and to provide cleanliness and ease of maintenance (page 2 lines 17-20 of machine translation, Zhou). The substitution of the motor and the power source configuration of Berthier with the configuration where the motor and power source are in an enclosed base as taught by Zhou is no more than the simple substitution of one known element for another or the application of a known technique to a piece of prior art ready for improvement. KSR Int’l Co. v. Teleflex Inc., 127 S.Ct. 1727, 1740-41 (2007).
The combination of Berthier and Zhou does not explicitly teach wherein the fixed predetermined angel from the rotor plane is between 0 and 60 degrees, inclusive.
Howell discloses analogous art related to a fixed angle centrifuge rotor, wherein the fixed predetermined angel from the rotor plane is between 0 and 60 degrees, inclusive (fixed angle of 45° with respect to the central portion 32C, i.e., the axis of rotation, col. 5 lines 45-59, Fig. 3). It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to have provided the method of the combination of Berthier and Zhou with the fixed angle as taught by Howell for the purpose of separating a liquid sample, such as a sample of a body liquid, prior to analysis (col. 1 lines 19-23, Howell).
Regarding claim 14, the combination of Berthier, Zhou, and Howell discloses placing and removing the sample tube is manual and free of tools (col. 2 lines 1-3, Berthier).
Regarding claim 16, the combination of Berthier, Zhou, and Howell discloses wherein the method steps are free of a user activating a start of spinning of the rotor, other than closing the lid (col. 7 lines 1-12, Berthier).
Regarding claim 17, the combination of Berthier, Zhou, and Howell discloses wherein the method steps are free of a user activating a stop of spinning of the rotor (claim 1, Berthier).
Regarding claim 18, the combination of Berthier, Zhou, and Howell discloses wherein the method steps are free of tools (col. 2 lines 1-3, Berthier).
Regarding claim 19, the combination of Berthier, Zhou, and Howell discloses wherein the method steps are free of manually balancing of the rotor (Fig. 1D; counterbalance 26A is already disposed in the rotor and does not need user manipulation, Berthier).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Berthier in view of Zhou, and further in view of Howell, as applied to claim 1 above, in view of CN 209901509 (Zhang).
Regarding claim 11, the combination of Berthier, Zhou, and Howell does not disclose the rotor is free of moving parts, other than an elasticity of a material of which the rotor is fabricated.
Zhang discloses the rotor is free of moving parts, other than an elasticity of a material of which the rotor is fabricated (Abstract). It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to have provided the centrifuge of the combination of Berthier, Zhou, and Howell with the rotor material taught by Zhang for the purpose of the centrifugal operation of glass tube (Abstract, Zhang).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Berthier in view of Zhou, and further in view of Howell, as applied to claim 13 above, and further in view of Hein (U.S. Patent No. 3,239,136)
Regarding claim 15, the combination of Berthier, Zhou, and Howell discloses the centrifuge is free of visual user controls, free of user display (col. 7 lines 63-67, Berthier), free of connecting wires (col. 8 lines 41-50, Berthier), but does not disclose free of a wireless data interface.
Hein discloses wherein the centrifuge is free of a wireless data interface (e.g., Fig. 4). It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to have provided the method of the combination of Berthier, Zhou, and Howell with no wireless data interface as is in the case in the centrifuge of Hein for the purpose of performing blood separation at a patient’s bed side (col. 4 lines 28-43, Hein).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Berthier in view of Zhou, and further in view of Howell, as applied to claim 13 above, in view of Berthier et al. (U.S. Patent Application Pub. No. 2016/0174888, hereinafter Berthier ‘888).
Regarding claim 20, the combination of Berthier, Zhou, and Howell does not disclose the fluid sample tube length is less than or equal to 50mm and the fluid sample volume is in the range of 20 µL to 1000 µL.
Berthier ‘888 discloses the fluid sample length is less than or equal to 50mm (para. [0172]) and the fluid sample volume is in the range of 20 µL to 1000 µL (para. [0102]; tube can be a standard Eppendorf tube which include 500µL in volume as well known in the art). It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to have provided the method of the combination of Berthier, Zhou, and Howell with the fluid sample tube of Berthier ‘888 for the purpose of collecting samples in a simple manner and have an integrated fluidic transfer to a container or receptable that houses the samples for use in point-of-care devices (para. [0003]).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Berthier in view of Zhou, and further in view of Greenstein (U.S. Patent No. 5,207.634).
Regarding claim 21, Berthier discloses a portable centrifuge (centrifuge system 10, Fig. 1D) comprising: a rotor (24, Fig. 1D) rotatable by the a motor (25, Fig. 1D) about an axis of rotation and above the enclosed base, the rotor comprising: a rotor body; exactly one tube retainer (opening 26, Fig. 1D) adapted to manually, removably hold exactly a single fluid sample tube (tube 36, Fig. 3B); and a counterweight (counterbalance 26A, Fig. 1D) adapted to counterbalance the rotor when rotating with the single fluid sample tube, wherein the counter weight is monolithic with the exactly one tube retainer (tube retainer 26 and counter weight 26A are both part of the same rotor body 24, Fig. 1D); and a lid (20, Fig. 1D) pivotably attached to the enclosed base, wherein the lid is configured to selectively cover the rotor, but does not disclose an enclosed base; a motor within the enclosed base; a power source within the enclosed base; the counterweight comprising a wider section and a narrower section, wherein the wired section is more distal from the axis of rotation than the narrower section.
Zhou discloses an enclosed base 3; a motor 23 within the enclosed base; a power source 22 within the enclosed base (Fig. 2). It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to have provided the method of Berthier with the base with an internal top surface as taught by Zhou so that the motor and power source are below the internal top surface and enclosed within the base, and the rotor plane and tube retainer are above the internal top surface for the purpose of compact structure and small occupied space (Abstract, Zhou), as well as to isolate the process chamber from the motor and power source to prevent cross-contamination and to provide cleanliness and ease of maintenance (page 2 lines 17-20 of machine translation, Zhou). The substitution of the motor and the power source configuration of Berthier with the configuration where the motor and power source are in an enclosed base as taught by Zhou is no more than the simple substitution of one known element for another or the application of a known technique to a piece of prior art ready for improvement. KSR Int’l Co. v. Teleflex Inc., 127 S.Ct. 1727, 1740-41 (2007).
The combination of Berthier and Zhou does not disclose the counterweight comprising a wider section and a narrower section, wherein the wired section is more distal from the axis of rotation than the narrower section.
Greenstein discloses the counterweight 22 comprising a wider section and a narrower section, wherein the wired section is more distal from the axis of rotation than the narrower section (Fig. 7). It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to have provided the centrifuge of the combination of Berthier and Zhou with the counterweight of Greenstein for the purpose of providing adjustable counterweights allow high rotational speeds without any significant imbalance of the rotor imparting undesired vibrations to the sample containers or to the supporting structure, bearings, etc. of the instrument (col. 5 lines 12-36, Greenstein).
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Berthier in view of Zhou, and further in view of Greenstein, as applied to claim 21 above, and further in view of FR 3147117 (Rolland et al., hereinafter Rolland).
Regarding claim 22, the combination of Berthier, Zhou, and Greenstein does not disclose wherein the counterweight comprises a leading surface and a trailing surface with respect to a direction of rotation, and wherein at least one of the leading surface or the trailing surface is tapered.
Rolland discloses wherein the counterweight 22 comprises a leading surface and a trailing surface with respect to a direction of rotation, and wherein at least one of the leading surface or the trailing surface is tapered (Fig. 9). It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to have provided the centrifuge of the combination of Berthier, Zhou, and Greenstein with the counterweight as taught by Rolland for the purpose of not coming into contact with an obstacle placed in the center of the centrifuge (page 4 lines 4-9 of machine translation, Rolland).
Conclusion
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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHUYI S LIU whose telephone number is (571)272-0496. The examiner can normally be reached MON - FRI 9:30AM - 2:30PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Claire Wang can be reached on 571-270-1051. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Shuyi S. Liu/Examiner, Art Unit 1774
/CLAIRE X WANG/Supervisory Patent Examiner, Art Unit 1774