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 9 October 2025 have been fully considered but they are not persuasive. The existing prior art applied is deemed to render the pending claims obvious as expressed in the rejections below.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Drawings
The drawings were received on 23 February 2023. These drawings are acceptable.
Specification
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant's cooperation is requested in correcting any errors of which applicant may become aware of in the specification.
The abstract of the disclosure is acceptable.
The title of the invention is acceptable.
Claim Interpretation
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.
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.
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.
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. Such claim limitations are: holding means in claim 14. 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.
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, 2, 6, 7, 10, 11, 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over the admitted prior art in paras. [0002]-[0005] of the present specification in view of Szent-Gyorgyi et al. (U.S. Patent No. 2,834,541, hereinafter Szent-Gyorgyi).
Regarding claim 1, the admitted prior art discloses a convention cell washing centrifuge (Fig. 10A and 10B, paras. [0002]-[0005]) comprising: a motor having a drive shaft (para. [0002]); a rotor body (31, Fig. 10) connected to the drive shaft of the motor and rotated by the motor; a plurality of test tube holders (36, Fig. 10) mounted in a circular array to turning shafts on an outer peripheral side of the rotor body and supported to be capable of turning in an outer horizontal direction of the circular array by centrifugal force; a washing liquid distribution element (150, Fig. 10) which is mounted to the rotor body and supplies a washing liquid into a plurality of test tubes respectively held by the plurality of test tube holders by discharging the washing liquid in a radial direction from a rotation center toward an outer periphery; and a control device controlling the motor (a control device is considered to be inherently and necessarily present in the type of conventional centrifuge of the admitted prior art), wherein the washing liquid distribution element comprises an upper distribution element (151, Fig. 10) and a lower distribution element (161, Fig. 10), the upper distribution element comprises a washing liquid introduction part having a washing liquid introduction port (154, Fig. 10) at a center, and an upper annular part continuous at a periphery of the washing liquid introduction part, and a lower annular part (164, Fig. 10) arranged at a position on a radially outer side of the concave part and opposed to the upper annular part, a plurality of grooves (167, Fig. 10) in a radial pattern are formed in one of a lower surface of the upper annular part and an upper surface of the lower annular part, and flow paths through which the washing liquid is discharged from the washing liquid distribution element are formed by joining the grooves to the opposing annular part (Fig. 10A and 10B), but does not disclose the lower distribution element comprises a concave part recessed in a direction away from a side on which the upper distribution element is positioned, and an inclined part that rises as it goes toward the radially outer side is formed at an outer edge of the concave part to supply the washing liquid to the flow paths by centrifugal force, wherein the concave part comprises the inclined part and an axial center part formed on an inner side of the inclined part, the axial center part protrudes upward relatively to the inclined part, and a top of the axial center part is located at a position lower than the grooves and the washing liquid introduction port.
Szent-Gyorgyi discloses a washing liquid distribution element (distributor cup 41, Fig. 1) comprises a lower distribution element comprising a concave part (concave well-floor 43, Fig. 1) recessed in a direction away from a side on which the upper distribution element is positioned, and an inclined part that rises as it goes from a central axis of rotation toward the radially outer side is formed at an outer edge of the concave part to supply the washing liquid to the flow paths by centrifugal force (see annotated partial Fig. 3), wherein the concave part comprises the inclined part and an axial center part (screw 39, Fig. 3) formed on an inner side of the inclined part, the axial center part protrudes upward relatively to the inclined part, and a top of the axial center part is located at a position lower than the grooves (corresponding to the plurality of horizontal radially disposed apertures 44, Fig. 3) and the washing liquid introduction port (feed tube 53, Fig. 3) (see annotated partial Fig. 3 below). 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 admitted prior art with the lower distribution element as taught by Szent-Gyorgyi et al. for the purpose of having liquid from the concave part to be equally distributed into test tubes (col. 3 line 65 – col. 4 line 3).
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Regarding claim 2, the combination of the admitted prior art and Szent-Gyorgyi discloses wherein the concave part 43 comprises the inclined part and an axial center part 39 formed on an inner side of the inclined part, and the inclined part occupies half or more of the concave part in the radial direction, and the axial center part is formed of a flat surface or a curved surface having an inclination different from that of the inclined part (Fig. 2 and 3, Szent-Gyorgyi). I
Regarding claim 6, the combination of the admitted prior art and Szent-Gyorgyi discloses wherein the flow paths (167, Fig. 10, admitted prior art) formed by joining the upper distribution element and the lower distribution element are arranged at equal intervals in a circumferential direction (Fig. 10B, admitted prior art), and the lower surface of the upper distribution element and the upper surface of the lower distribution element are in close contact with each other at a portion (164a, Fig. 10B, admitted prior art) other than the grooves when viewed in the circumferential direction (Fig. 10A, admitted prior art), and the upper distribution element and the lower distribution element are fixed by providing screw parts at each of the surfaces 164a in close contact (the upper and lower distribution elements are fixed via screw holes 168 and hence by screws not shown in Fig. 10B, admitted prior art).
Regarding claim 7, the combination of the admitted prior art and Szent-Gyorgyi discloses wherein a width of the flow path when viewed in the circumferential direction is wide on an inner peripheral edge side of the lower distribution element, and has a cross section of the flow path that narrows as it goes toward the radially outer side (the flow path from the washing liquid receiving part 163 narrows as it enters the groove 167 towards the injection port 167b, Fig. 10B, admitted prior art).
Regarding claim 10, the combination of the admitted prior art and Szent-Gyorgyi discloses wherein the inclined part has a vertical cross-sectional shape that is an arcuate shape (Fig. 3, Szent-Gyorgyi).
Regarding claim 11, modified admitted prior art does not disclose wherein the washing liquid distribution element is fixed to the rotor body by screws.
Szent-Gyorgyi further discloses wherein the washing liquid distribution element is fixed to the rotor body by screws 39 (col. 3 lines 19-22). 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 modified admitted prior art with the screws as taught by Szent-Gyorgyi for the purpose of securing the washing liquid distribution element to the rotor (col. 3 lines 19-22).
Regarding claim 13, the combination of the admitted prior art and Szent-Gyorgyi discloses a rotor (130, Fig. 10, applied prior art) for a centrifuge, comprising: the rotor body (31, Fig. 10, applied prior art) according to any one of claim 1; the plurality of test tube holders (36, Fig. 10, applied prior art) mounted in a circular array to the rotor body; and the washing liquid distribution element (150, Fig. 10, applied art) mounted to the rotor body (Fig. 10A and 10B; paras. [0002]-[0005]), wherein the rotor body (22, Fig. 1, Szent-Gyorgyi) comprises a mounting part (ring member 21 and/or bolts 23, Fig. 1, Szent-Gyorgyi) mounted to a drive shaft (13, Fig. 1, Szent-Gyorgyi) of a centrifuge and is configured to be detachable from the drive shaft (col. 2 lines 54-58, Szent-Gyorgyi).
Regarding claim 14, the combination of the admitted prior art and Szent-Gyorgyi discloses a holding means which holds the test tube at a vertical angle or at an angle close to the vertical angle by preventing turning of the test tube holder (para. [0002], applied prior art).
Claims 3, 4, 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over the admitted prior art in view of Szent-Gyorgyi, as applied to claim 2 above, and further in view of GB 1241539.
Regarding claim 3, the combination of the admitted prior art and Szent-Gyorgyi discloses wherein the washing liquid introduction part comprises a neck part (151a, Fig. 10, applied prior art) connected to an inner peripheral edge part of the upper annular part (annular part of upper washing liquid distribution element 151 in Fig. 10a, applied prior art), but does not disclose an annular part protruding form an upper edge part of the neck part toward one or both of a radially inner side and a radially outer side, and the washing liquid introduction port is formed by the annular part.
GB 1241539 discloses an annular part (top wall 43, Fig. 3) protruding form an upper edge part of the neck part (outer wall of element 39, Fig. 3) toward one or both of a radially inner side and a radially outer side, and the washing liquid introduction port (central opening 47, Fig. 3) is formed by the annular part. 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 the admitted prior art and Szent-Gyorgyi with the annular part as taught by GB 1241539 for the purpose of defining an annular inlet for the washing liquid distribution element (page 3 lines 42-45, GB 1241539).
Regarding claim 4, the combination of the admitted prior art, Szent-Gyorgyi and GB 1241539 discloses wherein the washing liquid introduction port (feed port 53, Fig. 3, Szent-Gyorgyi) is positioned higher than a dividing plane between the upper distribution element (upper portion of distributor cup 41, Fig. 3, Szent-Gyorgyi) and the lower distribution element (lower portion of distributor cup 41, Fig. 3, Szent-Gyorgyi).
Regarding claims 8 and 9, the modified admitted prior art does not disclose wherein the inclined part has a vertical cross-sectional shape that is a straight line shape, and has an inclination of 10 degrees to 45 degrees with respect to a horizontal plane; wherein the inclined part has a vertical cross-sectional shape that is a straight line shape, and has an inclination of 25 degrees to 35 degrees with respect to a horizontal plane.
GB 1241539 discloses wherein the inclined part has a vertical cross-sectional shape that is a straight line shape, and has an inclination of 2 to 10 degrees from the vertical (page 3 lines 72-76), and teaches that the inclination angle would vary depending upon the intended rotational speed of the unit and the type of fluid to be distributed (page 3 lines 78-80), and the chosen slope is aimed at achieving a rapid and complete empty of the manifold chamber and imparting to the washing fluid sufficient velocity to insure complete mixing of the fluid and the cells to be washed (page 4 lines 3-20). While GB 1241539 does not specifically teach an inclination of 10 degrees to 45 degrees or 25 degrees to 35 degrees with respect to the horizontal plane, based on the teachings of GB 1241539, the inclination angle would be considered a result effective variable by one having ordinary skill in the art before the effective filing date of the claimed invention. It would have been obvious to one of ordinary skill in the art to determine the optimum inclination angle for the centrifuge of the combination of admitted prior, Szent-Gyorgyi and GB 1241539, such as an angle in the claimed ranges, for the purpose of achieving optimum emptying of the concave part and complete mixing of the fluid and the cells to be washed (page 4 lines 3-20, GB 1241539). See In re Aller, Lacey, and Hall (10 USPQ 233-237) “It is not inventive to discover optimum or workable ranges by routine experimentation”. Note that the specification contains no disclosure of either the critical nature of the claimed ranges or any unexpected results arising therefrom. Where patentability is said to be based upon particular chosen dimensions or upon another variable recited in a claim, the Applicant must show that the chosen dimensions are critical. In re Woodruff, 919 f.2d 1575, 1578, 16 USPQ2d 1934, 1936 (Fed. Cir. 1990).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over the admitted prior art in view of Szent-Gyorgyi, as applied to claim 1 above, and further in view of Intengan (U.S. Patent No. 4,285,463), and as evidenced by Feix et al. (Feix, T., Bullock, I. M., & Dollar, A. M. (2014). Analysis of Human Grasping Behavior: Object Characteristics and Grasp Type. IEEE Transactions on Haptics, 7(3), 311–323. https://doi.org/10.1109/toh.2014.2326871, hereinafter Feix).
Regarding claim 5, the combination of the admitted prior art and Szent-Gyorgyi does not disclose wherein a flange part is provided at an outer peripheral part of the washing liquid introduction port, and a diameter of the flange part is 80 mm or less.
Intengan discloses wherein a flange part 76 is provided at an outer peripheral part of the washing liquid introduction port 72 (Fig. 3). Intengan does not teach specific dimensions for the diameter of the flange part. However, since the flange part is designed to assist the user in gripping (col. 7 lines 12-15), it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to configure the flange part of Intengan with a dimension that would allow the user to grasp and lift the rotor head assembly, such as a dimension of 80 mm or less.
For example, Feix discloses dimensions of various objects that can be grasped by the human hand including 80 mm or less (Table 2). Given the teaching of Feix, it would have been obvious to determine the optimum dimension of the flange part of Intengan needed for the user to grasp and lift the rotor assembly. See In re Aller, Lacey, and Hall (10 USPQ 233-237) “It is not inventive to discover optimum or workable ranges by routine experimentation”. Note that the specification contains no disclosure of either the critical nature of the claimed range or any unexpected results arising therefrom. Where patentability is said to be based upon particular chosen dimensions or upon another variable recited in a claim, the Applicant must show that the chosen dimensions are critical. In re Woodruff, 919 f.2d 1575, 1578, 16 USPQ2d 1934, 1936 (Fed. Cir. 1990). 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 the admitted prior art and Szent-Gyorgyi with the flange part of Intengan as evidenced by Feix for the purpose of assisting the user in gripping the rotor head assembly and lifting it (col. 7 lines 12-15, Intengan).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over the admitted prior art in view of Szent-Gyorgyi, and further in view of GB 1241539, as applied to claim 3 above, and further in view of Intengan, and as evidenced by Feix.
Regarding claim 12, the combination of the admitted prior art, Szent-Gyorgyi, and GB 1241539 does not disclose wherein an inner diameter of the annular part is 60 mm or more and 80 mm or less.
Intengan discloses an annular part 76 (Fig. 3), but does not teach specific dimensions for the inner diameter of the annular part. However, since the annular part is designed to assist the user in gripping (col. 7 lines 12-15), it would be obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to configure the annular part of Intengan with a dimension that would allow the user to grasp and lift the rotor head assembly, such as a dimension of 60 mm or more and 80 mm or less.
For example, Feix discloses dimensions of various objects that can be grasped by the human hand including 60 mm (Table 2). Given the teaching of Feix et al., it would have been obvious to determine the optimum dimension of the annular part of Intengan needed for the user to grasp and lift the rotor assembly. See In re Aller, Lacey, and Hall (10 USPQ 233-237) “It is not inventive to discover optimum or workable ranges by routine experimentation”. Note that the specification contains no disclosure of either the critical nature of the claimed range or any unexpected results arising therefrom. Where patentability is said to be based upon particular chosen dimensions or upon another variable recited in a claim, the Applicant must show that the chosen dimensions are critical. In re Woodruff, 919 f.2d 1575, 1578, 16 USPQ2d 1934, 1936 (Fed. Cir. 1990). 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 the admitted prior art, Szent-Gyorgyi, and GB 1241539 with the annular part of Intengan as evidenced by Feix for the purpose of assisting the user in gripping the rotor head assembly and lifting it (col. 7 lines 12-15, Intengan).
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 mailing 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 at 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