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 17 February 2026 with respect to the pending claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 17 August 2022. 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.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Romanauskas (U.S. Patent No. 5,236,409) in view of Henne et al. (U.S. Patent Application Pub. NO. 2016/0310966, hereinafter Henne).
Regarding claim 6, Romanauskas discloses an adapter (10, Fig. 1) for use with a rotor well (cavity C, Fig. 9) of a fixed-angle rotor (R, Fig. 9), the rotor well having a central axis (10A, Fig. 9) in a fixed angular relationship relative to a rotational axis of the rotor (CL, Fig. 9) to define a rotor well angle, comprising: a body (body member 12, Fig. 9) extending between a first end and a second, the body configured to be received within the rotor well of the fixed-angle rotor (see e.g., Fig. 9); and a cavity (internal recess 34, Fig. 9) formed in the body and being configured to receive a sample tube (T, Fig. 9) therein, the cavity extending from an opening at the first end of the body to a closed base at the second end of the body (see Fig. 9), the cavity having a longitudinal axis (34A, Fig. 9) such that when the adapter is positioned within the rotor well of the rotor the longitudinal axis of the cavity has an angular relationship relative to the rotational axis of the rotor that defines a cavity angle; wherein the cross-sectional area is defined as a plane disposed transverse to the longitudinal axis of the body and that intersects the cavity; and wherein the cavity angle is different compared to the rotor well angle (axis 34A of the recess 34 is inclined with respect to the axis 10A of the adapter, col. 8 lines 58-62), but does not disclose a body having an external cross-sectional perimeter that changes in shape along a length of the body between a neck at the first end and the second end.
Henne discloses analogous art related to an adapter (fixed angle container 3, Fig. 3), comprising a body extending between a first end and a second end and having an external cross-sectional perimeter that changes in shape along a length of the body between a neck at the first end and the second end (the external cross-section perimeter changes along the length of the adapter body from the collar 34, to the trunnions 33, to the base body 31, to locking protrusions 35, to the vessel bottom 32, see Fig. 3), the body configured to be received within the rotor well (receptacle, Fig. 1). 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 adapter of Romanauskas with the adapter body shape as taught by Henne for the purpose of preventing tilting of the fixed angle container, so that the fixed angle does not change during the entire centrifuge run (para. [0046]).
Claims 7, 10-12, 14, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Romanauskas in view of GB 2222538 (Nielsen), and further in view of Edwards et al. (U.S. Patent No. 4,306,676, hereinafter Edwards ).
Regarding claim 7, Romanauskas discloses an adapter (10, Fig. 1) for use with a rotor well (cavity C, Fig. 9) of a fixed-angle rotor (R, Fig. 9), the rotor well having a central axis (10A, Fig. 9) in a fixed angular relationship relative to a rotational axis of the rotor (CL, Fig. 9) to define a rotor well angle, comprising: a body (body member 12, Fig. 9) extending between a first end and a second end, the body configured to be received within the rotor well of the fixed-angle rotor (see e.g., Fig. 9); and a first cavity (internal recess 34, Fig. 9) formed in the body and being configured to receive a sample tube (T, Fig. 9) therein, the first cavity extending from an opening at the first end of the body to a closed base at the second end of the body (see Fig. 9), the first cavity having a longitudinal axis (34A, Fig. 9) such that when the adapter is positioned within the rotor well of the rotor the longitudinal axis of the cavity has an angular relationship relative to the rotational axis of the rotor that defines a first cavity angle; wherein the first cavity angle is different compared to the rotor well angle (axis 34A of the recess 34 is inclined with respect to the axis 10A of the adapter, col. 8 lines 58-62), but does not disclose a body having a single flattened surface that tapers between a neck near the first end to the second end of the body, wherein the single flattened surface is arranged so as to be free of engagement with the rotor well when the adapter is positioned within the rotor well.
Nielsen discloses analogous art related to an adapter (1, Fig. 3), comprising a body having a cross-sectional area that tapers (transition region 5 and reduced diameter segment 6, Fig. 3) between a neck (lower edge 4, Fig. 3) near the first end and the second end (hemispherical adapter bottom 7, Fig. 3), wherein the body surface in the tapering section is free of engagement with the rotor well when the adapter is positioned within the rotor well (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 adapter of Romanauskas with the body shape taught by Nielsen for the purpose of allowing the easy removal of the adapter and tube after centrifugation (Abstract, Nielsen).
The combination of Romanauskas and Nielsen does not specifically disclose the adapter body having a single flattened surface that tapers between a neck near the first end to the second end of the body, wherein the single flattened surface is arranged so as to be free of engagement with the rotor well when the adapter is positioned within the rotor well.
Edwards discloses analogous art related to an adapter, the body having a single flattened surface (see annotated Fig. 3 below) that tapers between a neck near the first end to the second end of the body, wherein the single flattened surface is arranged so as to be free of engagement with the rotor well when the adapter is positioned within the rotor well (see annotated 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 single flattened surface taught by Edwards to the adapter of the combination of Romanauskas and Nielsen for the purpose of inserting a tab to indicate that the adapter is correctly oriented about its cylindrical axis so that the mouth of each small cavity faces the center of centrifuge rotor (col. 3 lines 52-59, Edwards ).
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Regarding claim 10, the combination of Romanauskas, Nielsen, and Edwards discloses wherein the first end is circular in cross-sectional shape (first top end of body member 12 is circular, Fig. 9, Romanauskas).
Regarding claim 11, the combination of Romanauskas, Nielsen, and Edwards discloses wherein the second end of the adapter only engages with a portion of a base of the rotor well when positioned therein (reduced diameter segment 6 engages with a portion of the a base of the swinging bucket 14, Fig. 3, Nielsen).
Regarding claims 12 and 14, the combination of Romanauskas, Nielsen, and Edwards discloses wherein the first cavity angle is within a range of between 0° to 15° greater than the rotor well angle (col. 5 lines 6-16, Romanauskas), but does not specifically disclose a range of between 28° to 37°, or between 14° to 17° greater than the rotor well angle. However, it has been held that in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997). Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985); In re Scherl, 156 F.2d 72, 74-75 (CCPA 1946); see also Warner-Jenkinson Co., Inc. v. Hilton Davis Chemical Co., 520 U.S. 17 (1997); In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); In re Lilienfeld, 67 F.2d 920, 924 (CCPA 1933). See MPEP 2144.05. In this case, the combination of Romanauskas, Nielsen, and Edwards either teaches a range that overlaps with the claimed range or a range that lies close to the claimed range. Without evidence to indicate why a range of between 28° to 37°, or between 14° to 17° greater than the rotor well angle is critical, 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 a first cavity angle that is within a range of between 28° to 37°, or a range of between 14° to 17° greater than the rotor well angle, for the purpose of selecting an angle consistent with the separation being performed (col. 5 lines 11-16, Romanauskas).
Regarding claim 17, the combination of Romanauskas, Nielsen, and Edwards discloses wherein the first end of the body (11, Fig. 3) includes an orientation marking (tab 21, Fig. 3) configured to be directed away from the rotational axis of the rotor when the adapter is positioned within the rotor well (when the tab is inserted in the notch, test tube holder 10 is correctly oriented about its cylindrical axis so that the mouth 16 of each small cavity 15 faces the center of centrifuge rotor 30, col. 3 lines 52-69, Edwards).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Romanauskas in view of Nielsen, and further in view of Edwards, as applied to claim 7 above, and further in view of Lam et al. (U.S. Patent No. 4,553,955, hereinafter Lam).
Regarding claim 13, the combination of Romanauskas, Nielsen, and Edwards does not explicitly teach wherein the rotor well angle is within a range of between 20° to 45°.
Lam discloses analogous art relating to an adapter, wherein the rotor well angle is between 25° and 45° (col. 1 lines 31-33). 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 adapter of the combination of Romanauskas, Nielsen, and Edwards with the rotor well angle taught by Lam for the purpose of selecting an angle based on the sample content and the tope of molecular separation which is desired to be performed by the centrifuge (col. 1 lines 31-53, Lam).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Romanauskas in view of Nielsen, and further in view of Edwards, as applied to claim 7 above, and further in view of Moore et al. (U.S. Patent Application Pub. No. 2004/0209755, hereinafter Moore).
Regarding claim 20, the combination of Romanauskas, Nielsen, and Edwards does not disclose wherein the body includes one or more hollow areas located within the body and about the cavity.
Moore discloses analogous art related to an adapter (1, Fig. 1), wherein the body includes one or more hollow areas (holes 5, Fig. 1) within the body and about the cavity (pocket 6, Fig. 1). 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 adapter of the combination of Romanauskas, Nielsen, and Edwards with the hollow areas taught by Moore for the purpose of reducing the weight of the adapter (para. [0050], Moore).
Claims 22 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Romanauskas in view of Nielsen, and further in view of Edwards, as applied to claim 7 above, and further in view of Anthony (U.S. Patent No. 4,692,137).
Regarding claims 22 and 23, the combination of Romanauskas, Nielsen, and Edwards does not expressly teach wherein the cavity includes a first bore having an outer diameter that forms the opening of the cavity and a second bore having a smaller outer diameter forms a body of the cavity, the first bore being configured to receive a portion of a sample tube cap therein; wherein a shoulder is formed between the first and second bores of the cavity, the shoulder being configured to abut the sample tube cap so that a portion of the sample tube cap remains outside of the cavity when the sample tube is positioned therein.
Anthony discloses analogous art related to an adapter (10, Fig. 1), wherein the cavity includes a first bore (see annotated Fig. 1 below) having an outer diameter that forms the opening of the cavity and a second bore (see annotated Fig. 1) having a smaller outer diameter forms a body of the cavity, the first bore being configured to receive a portion of a sample tube cap (“cap”, col. 4 lines 37-41) therein; wherein a shoulder (see annotated Fig. 1) is formed between the first and second bores of the cavity, the shoulder being capable of being configured to abut the sample tube cap so that a portion of the sample tube cap remains outside of the cavity when the sample tube is positioned therein. 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 adapter of the combination of Romanauskas, Nielsen, and Edwards with the adapter cavity configuration taught by Anthony for the purpose of fitting closely about the centrifuge tube to prevent undesired motion thereof during centrifuge operations and to facilitate manual access to the upper end of the centrifuge tube to facilitate its removal from one of the adapter sections (col. 3 lines 20-34, Anthony).
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Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Romanauskas in view of Nielsen, and further in view of Edwards, as applied to claim 7 above, and further in view of Anthony and admitted prior art in para. [0051] of the present specification.
Regarding claim 24, the combination of Romanauskas, Nielsen, and Edwards does not explicitly teach wherein the cavity includes a cavity draft angle within a range of between 0° < and ≤ 1°.
Anthony discloses analogous art related to an adapter (10, Fig. 1), wherein the cavity (trough 20, Fig. 3A) has a long portion 10A that fits closely about the centrifuge tube (col. 3 lines 20-34). The present application in para. [0051] admits that commercially available conical shaped sample tubes typically have a draft angle between 0° < and ≤ 1°. Given the admitted fact that commercially available conical tubes already include a slight draft angle of 0° < and ≤ 1°, 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 adapter of Anthony with a cavity draft angle in the claimed range in order to match the geometry of the adapter recess to the geometry of the centrifuge tube. The motivation is expressly taught by Anthony to shape the recess to fit closely about the centrifuge tube to prevent tube motion (col. 3 lines 20-34, Anthony). Doing so represents no more than the predictable use of prior art elements according to their established functions. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007). 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 adapter of the combination of Romanauskas, Nielsen, and Edwards with the adapter cavity configuration taught by Anthony and the admitted prior art for the purpose of fitting closely about the centrifuge tube to prevent undesired motion thereof during centrifuge operations and to facilitate manual access to the upper end of the centrifuge tube to facilitate its removal from one of the adapter sections (col. 3 lines 20-34, Anthony).
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
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