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 28 January 2026 have been fully considered but they are not persuasive.
In response to Applicant’s argument that Wait’s “surfaces define a radius of curvature along a plane that is parallel to the central axis, whereas currently amended claim 1 requires the plane on which the curve lies to be ‘transverse to the central axis.’ Therefore, the radius referred to in Wait does not fall within the definition of the radius defined in independent claim 1” (page 8, Remarks), the examiner points out that Wait is relied upon only for teaching the selection and optimization of a radius of curvature of a surface within a vessel to control fluid flow characteristics, such as reduced turbulence (col. 3, lines 86-91, Wait). The rejection therefore relies on Wait merely to show that selection of an appropriate radius of curvature for an internal curved surface of a fluid handling vessel is a result-effective variable, and that optimization of such curvature would have been obvious to one of ordinary skill in the art. Herman already teaches curved baffles extending inward from the vessel wall, along a plane defined as transverse to the central axis as now claimed, and it would have been obvious to one of ordinary skill in the art to select an appropriate radius of curvature for those baffles based on routine design considerations related to fluid flow within the vessel. The rejection over Whitehead, Kitamura, Herman, and Wait is therefore still deemed valid and is maintained.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Drawings
The drawings were received on 20 June 2025. These drawings are 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: a first holding means in claim 13, and a second 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 § 112
In light of the claim amendments filed 28 January 2026, the rejections under 35 U.S.C. 112(b) are withdrawn.
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 1-5 and 7-12 are rejected under 35 U.S.C. 103 as being unpatentable over Whitehead et al. (U.S. Patent No. 2,882,103, hereinafter Whitehead) in view of Kitamura et al. (U.S. Patent Application Pub. No. 2001/0019842, hereinafter Kitamura), further in view of Herman et al. (U.S. Patent Application Pub. No. 2002/0045526, hereinafter Herman), and further in view of Wait (U.S. Patent No. 1,765,386).
Regarding claim 1, Whitehead discloses a pot (centrifuge vessel 10, Fig. 1) for centrifugal separation comprising: a wall (side wall member 16, Fig. 1) around a central axis, a top end (upper rim 38 and “a suitable cover”, Fig. 1, col. 2 lines 13-14) and a bottom end (bottom wall member 18, Fig. 1), wherein the pot comprises: a plurality of baffles (fins/vanes 34, Fig. 1) protruding from the wall into an inner volume of the pot; wherein the pot is configured to centrifugally separate a biological fluid into multiple components (col. 1 lines 9-11), but does not disclose a protrusion from the bottom end into the inner volume and around the central axis, wherein the plurality of baffles are each formed as an arc of a curve extending from the wall towards the central axis along a plane defined as transverse to the central axis, the curve having a radius between 0.12 and 0.18 of a width of the pot, and wherein the pot is configured to centrifugally separate a biological fluid into multiple components.
Kitamura discloses analogous art related to a pot (Fig. 1) for a centrifuge, and a protrusion (columnar dam 5) from the bottom end into the inner volume and around the central axis (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 pot of Whitehead with the protrusion taught by Kitamura for the purpose of gathering a low specific gravity component in the case of a specimen of a small amount (para. [0045], Kitamura).
Herman discloses analogous art related to a pot (centrifuge 20, Fig. 1) for centrifugal separation, a wall (outer liner 228, Fig. 18) around a central axis, a top end (top plate 27, Fig. 1) and a bottom end (base 29, Fig. 1); a plurality of baffles (spiral vanes 28 and/or 230, Fig. 2 and 19) protruding from the wall into an inner volume of the pot, wherein the plurality of baffles (spiral vanes 230, Fig. 19) are each formed as an arc of a curve extending from the wall towards the central axis along a plane defined as transverse to the central axis (Fig. 18-20, para. [0086], vanes 230 spirally extend in a generally radially inward direction with respect to longitudinal axis). 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 pot of the combination of Whitehead and Kitamura with the baffles as taught by Herman for the purpose of improving particulate separation (para. [0086], Herman).
The combination of Whitehead, Herman, and Kitamura teaches that the curvature of each spiral vane/baffle has a unique geometry (para. [0056], Herman), but does not specifically disclose the curve having a radius between 0.12 and 0.18 of a width of the pot.
Wait discloses analogous art related to designing radius of curvature of a surface inside a vessel to cause non-turbulent flow of a liquid within the vessel, wherein the radius of curvature of the concave portion being between ¼ and 10 times the diameter of the vessel (col. 3 lines 86-91). It has been held that 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. Without evidence to indicate why the curve having a radius between 0.12 and 0.18 of the width of the pot is critical, it would have been obvious for one having ordinary skill in the art to have modified the radius of curvature of Wait in the claimed range without producing any new or unexpected results. It would have been further obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the spiral baffles of the combination of Whitehead, Kitamura, and Herman with a curve having a radius as taught by Wait for the purpose of causing non-turbulent flow of a liquid within the vessel (col. 3 lines 86-91, Wait) since turbulent flow inside the centrifuge would be undesirable and detrimental to the separation of the components of the fluid.
Regarding claim 2, the combination of Whitehead, Kitamura, Herman, and Wait discloses wherein the pot is adapted to be spun on the central axis for centrifugal separation of the biological fluid in the inner volume, wherein the plurality of baffles is configured to have the multiple components remain separated once the pot ceases to spin (col. 3 lines 4-56, Whitehead).
Regarding claim 3, the combination of Whitehead, Kitamura, Herman, and Wait discloses wherein each of the plurality of baffles (fins/vanes 34, Fig. 1, Whitehead; spiral vanes 28 and/or 230, Fig. 2 and 19, Herman) does not protrude as far as a centre of the pot, and extends along the wall for between half of and all of a distance between the top end and the bottom end (Fig. 1, Whitehead; Fig. 19, Herman).
Regarding claim 4, the combination of Whitehead, Kitamura, Herman, and Wait discloses wherein the plurality of baffles 34 are substantially equally spaced around the central axis (“equally spaced fins or vanes 34”, col. 2 lines 4-5, Fig. 3, Whitehead).
Regarding claim 5, modified Whitehead does not disclose wherein the plurality of baffles comprises a first baffle that protrude from the wall by a first distance and a second baffle that protrudes from the wall by a second distance, the first distance being different from the second distance.
Herman discloses an embodiment wherein the plurality of baffles 69 and/or 70 comprises a first baffle 69 that protrude from the wall by a first distance and a second baffle 70 that protrudes from the wall by a second distance, the first distance being different from the second distance (Fig. 7C). 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 pot of modified Whitehead with the baffles as taught by Herman for the purpose of increasing the total vane surface area whenever the number of vanes and vane spacing may be limited by the close spacing a the hub inside diameter (para. [0063], Herman).
Regarding claim 8, the combination of Whitehead, Kitamura, Herman, and Wait discloses wherein the centrifugal separation separates plasma towards the central axis, and the pot is adapted to enable a component of the biological fluid to be extracted through an opening in the top end (col. 2 lines 11-16, col. 3 lines 45-56, Whitehead).
Regarding claim 12, the combination of Whitehead, Kitamura, Herman, and Wait discloses wherein the biological fluid is blood and the multiple components of the biological fluid comprise plasma and cellular matter (col. 1 lines 12-16, Whitehead).
Regarding claims 7, 9 and 10, the combination of Whitehead, Kitamura, Herman, and Wait discloses wherein the protrusion 5 from the bottom end is formed around the central axis with a width (outer diameter of dam 5 is 6 mm) of approximately half of a width of the pot (inner diameter of body 2 is 14 mm), and protrudes between 1 mm and 4 mm from the bottom end (height of dam 5 is 2 mm); wherein a width of the pot is less than 40 mm (inner diameter of body 2 is 14 mm); wherein a distance between the top end and the bottom end is less than 30 mm (depth of peripheral room 4 is 4 mm) (para. [0047], Kitamura).
Regarding claim 11, the combination of Whitehead, Kitamura, Herman, and Wait discloses wherein the pot is adapted to be spun at at least 10,000 RPM (par. [0048], Kitamura).
Claims 13, 14, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Whitehead, in view of Kitamura, further in view of Herman, and further in view of Wait, as applied to claim 1 above, and further in view of EP 1542020 (Thomasso et al., hereinafter Thomasso).
Regarding claims 13 and 14, the combination of Whitehead, Kitamura, Herman, and Wait discloses the pot according to claim 1, but does not disclose a consumable cartridge comprising: a cartridge body adapted to receive the pot, and a first holding means for holding the pot at least partly within the cartridge body, wherein the first holding means is adapted to allow the pot to rotate; further comprising a second holding means adapted to securely hold the pot in place until the cartridge is inserted into a centrifuge instrument, and to release the pot to spin freely when the cartridge is inserted into the centrifuge instrument.
Thomasso discloses a consumable cartridge (centrifuge module 30, para. [0049], Fig. 6) comprising: a cartridge body (housing 35, Fig. 6) adapted to receive the pot (centrifuge cup 31, Fig. 6), and a first holding means (engagement mechanism 42, Fig. 7) for holding the pot at least partly within the cartridge body, wherein the first holding means is adapted to allow the pot to rotate (para. [0050]; Fig. 6 and 7); further comprising a second holding means (base 33 and/or bearings 34, Fig. 6 and 7) adapted to securely hold the pot in place until the cartridge is inserted into a centrifuge instrument (centrifuge station 40, Fig. 3 and 7), and to release the pot to spin freely when the cartridge is inserted into the centrifuge instrument (para. [0049]; Fig. 6 and 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 implemented the pot of the combination of Whitehead, Kitamura, Herman, and Wait within Thomasso’s cartridge for the purpose of providing interchangeable centrifuge modules on the rotor to perform multiple processes on a single platform (para. [0042], Thomasso).
Regarding claim 16, the combination of Whitehead, Kitamura, Herman, Wait, and Thomasso discloses a consumable cartridge 30 adapted to hold the pot at least partly within the cartridge body when the pot is spinning at at least 10,000 RPM (para. [0050], Thomasso).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Whitehead in view of Kitamura, further in view of Herman, further in view of Wait, and further in view of Thomasso as applied to claim 13 above, and further in view of EP 3586971 (Nash et al., hereinafter Nash).
Regarding claim 15, the combination of Whitehead, Kitamura, Herman, Wait, and Thomasso discloses wherein the cartridge (housing 35, Fig. 6) is configured to be stationary during centrifugal separation (para. [0049]), but does not disclose a dispensing needle adapted to dispense the biological fluid into the pot, and an aspirating needle adapted to extract a component of the biological fluid from the pot.
Nash discloses analogous art related to a centrifuge for concentrating and collecting constituents of a biologic liquid mixture, and a dispensing needle (needle 334, para. [0032], Fig. 7) adapted to dispense the biological fluid into the pot (analogous to centrifuge chamber 312, Fig. 7) , and an aspirating needle (needle 334, para. [0032], Fig. 7; also teaches blood constituents removed via port 602 or 645 with a syringe and cannula, para. [0086], Fig. 25) adapted to extract a component of the biological fluid from the pot. 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 cartridge of the combination of Whitehead, Kitamura, Herman, Wait, and Thomasso with the dispensing needle and aspirating needle as taught by Nash for the purpose of permitting the introduction of a needle for the passage of whole blood into the chamber before the start of rotation, and removal of blood component at the cessation of action (para. [0032], Nash).
Conclusion
THIS ACTION IS MADE FINAL. 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