DETAILED ACTION
Preliminary Amendment filed on 11/09/2023 is acknowledged. Claims 1-23 are cancelled. Claims 24-43 are pending in the application.
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 .
Election/Restrictions
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claim 24-29 and 42-43, drawn to a centrifuge system shippable to and from a location of a patient, classified in B01D21/262.
II. Claim 40-41, drawn to a method of centrifuging a biological sample from a patient, classified in B01L2200/185.
The inventions are independent or distinct, each from the other because:
Inventions II and I are related as process and apparatus for its practice. The inventions are distinct if it can be shown that either: (1) the process as claimed can be practiced by another and materially different apparatus or by hand, or (2) the apparatus as claimed can be used to practice another and materially different process. (MPEP § 806.05(e)). In this case the apparatus as claimed can be used to practice another and materially different process.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
(a) the inventions have acquired a separate status in the art in view of their different classification;
(b) the inventions have acquired a separate status in the art due to their recognized divergent subject matter;
c) the inventions require a different field of search (for example, searching different classes/subclasses or electronic resources, or employing different search queries);
(d) the prior art applicable to one invention would not likely be applicable to another invention; and
(e) the inventions are likely to raise different non-prior art issues under 35 U.S.C. 101 and/or 35 U.S.C. 112, first paragraph.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Mathew Williams on 11/03/2025 a provisional election was made without traverse to prosecute the invention of group I, claim 24-29 and 42-43. Affirmation of this election must be made by applicant in replying to this Office action. Claim 40-41 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 24-39 and 42-43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-30 of U.S. Patent No. 11,673,133. Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and the currently patented claims expressly recite the same subject matter, it would have been obvious to one of ordinary skill in the art at the time the invention was made to employ both device and methods, as recited in both sets of claims.
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(s) 24, 27-29, 31-33, 37-39 and 42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rust et al. (US 2013/0265417, IDS) (Rust) in view of Eppendorf (Eppendorf Centrifuge 5418 / 5418 R Operating Manual, 2013).
Regarding claim 24, Rust discloses a centrifuge system shippable to and from a location of a patient (a portable centrifuge in remote or low resource area) (par [0024]), the centrifuge system comprising:
a container (capillary tube 66) having a lumen sized and shaped to receive a biological sample from the patient (Fig. 9, par [0035]);
a centrifuge assembly having a compartment (holder 46) sized and shaped to receive the container including the biological sample therein from the patient at the location of the patient (Fig. 4, par [0032][0035]); and
a lid (cover 24) moveable between a closed position and an open position (Fig. 1, par [0025]); and
an electronics system communicatively coupled to the centrifuge assembly, wherein the electronics system includes
a switch positioned to be activated when the lid is moved from the open position
to the closed position and deactivated when the lid is moved from the closed position to the open position (par [0025]); and
one or more processors (controller 38) programmed to execute centrifuge operation instructions stored in a non-transitory computer-readable storage medium (par [0030]), the centrifuge operations comprising
centrifuging the biological sample for a centrifugation duration when the switch is activated (par [0025]); and
stopping centrifugation of the biological sample if the switch is deactivated during the centrifugation duration (par [0025]).
Rust explicitly states that “the centrifuge 20 may include an interlock switch (not shown) that prevents the operation of the centrifuge 20 when the cover 24 is in the open position” (par [0025). This interlock switch is activated when the lid is closed and deactivated when the lid is opened.
Rust discloses a processor (controller 38) electrically coupled to the motor 30 and batteries 36 to control centrifuge operation (par [0030]). The centrifuge operates for a predetermined duration of time and speed (10,000 rpm for 90 seconds) (par [0036]) when the switch is activated (par [0025]). Because the interlock switch disables the motor when opened, centrifugation stops if the switch is deactivated. Thus, Rust teaches the claimed control logic.
Rust does not specifically disclose a primary seal operable to seal the biological sample within the lumen, and a secondary seal operable to seal the compartment around the primary container including the biological sample therein.
However, Eppendorf discloses a primary seal (tube lid) operable to seal the biological sample within the lumen (page 15), and a secondary seal (rotor lid) operable to seal the compartment around the primary container including the biological sample therein (page 21). It would have been obvious to one of ordinary skill in the art to use a primary seal (tube lid) operable to seal the biological sample within the lumen, in order to prevent the leak of the container. And it would have been obvious to one of ordinary skill in the art to use a secondary seal (rotor lid) operable to seal the compartment around the primary container including the biological sample therein, in order to further prevent the leak of rotor.
Regarding claim 27, Rust discloses that wherein the centrifugation operations further comprise preventing further centrifugation of the biological sample after the biological sample has been centrifuged for the centrifugation duration (the rotor is rotated for a desired period of time) (par [0036]).
Eppendorf also discloses that wherein the centrifugation operations further comprise preventing further centrifugation of the biological sample after the biological sample has been centrifuged for the centrifugation duration (The centrifuge automatically stops after the set time has elapsed. The elapsed centrifugation will be shown in a blinking display during the braking process) (page 25)
Regarding claim 28, Eppendorf discloses that wherein the centrifuge assembly further comprises a rotatable rotor, wherein the compartment comprises an opening in the rotor, and wherein the rotor includes the secondary seal (rotor lid) (page 21).
Regarding claim 29, Eppendorf discloses that wherein the centrifuge assembly further comprises a rotatable rotor and a cover (rotor lid), wherein the compartment comprises an opening in the rotor, wherein the cover is movable over the opening from an open position for receiving the container to a closed position in which the cover and the rotor define the secondary seal (page 21).
Regarding claim 31, Eppendorf discloses that wherein the secondary seal comprises a secondary container (rotor) positioned around the container (page 21).
Regarding claim 32, Rust discloses that wherein the centrifuge assembly further comprises a rotatable rotor, wherein the compartment comprises an opening in the rotor, and wherein the secondary container is removably positionable in the opening in the rotor (par [0008]).
Regarding claim 33, Rust discloses that wherein the centrifuge assembly further comprises a rotatable rotor, and wherein the secondary container is integrally formed with the rotor (par [0008]).
Regarding claim 37, Rust discloses that wherein the centrifuge assembly comprises a housing and a rotor positioned in the housing, wherein the housing defines the compartment, and wherein the rotor includes an opening sized and shaped to receive the container including the biological sample therein from the patient at the location of the patient (Fig. 3, par [0008]).
Regarding claim 38, Rust discloses that wherein the lid (24) is coupled to the housing, and wherein the lid is moveable between the closed position and the open position over the compartment (Fig. 3, par [0025]).
Regarding claim 39, Eppendorf discloses that wherein the secondary seal (rotor lid) is positioned between the lid (centrifuge lid) and the housing (page 17, 21).
Regarding claim 42, Rust discloses a centrifuge system shippable to and from a location of a patient (par [0024]), the centrifuge system comprising:
a centrifuge assembly, wherein the centrifuge assembly includes
a housing defining a compartment (Fig. 3, par [0008]);
a rotor rotatably positioned within the compartment and having an opening sized and shaped to receive a container including a blood sample therein from the patient at the location of the patient (par [0008]);
a lid (cover 24) coupled to the housing and moveable between a closed position and an open position over the compartment (Fig. 3, par [0025]); and
an electronics system communicatively coupled to the centrifuge assembly, wherein the electronics system includes
a switch between the lid and the housing, wherein the switch is positioned to be activated when the lid is moved from the open position to the closed position and deactivated when the lid is moved from the closed position to the open position (par [0025]); and
one or more processors programmed to execute centrifuge operation instructions stored in a non-transitory computer-readable storage medium (par [0030]), the centrifuge operations comprising
centrifuging the biological sample for a centrifugation duration when the switch is activated (par [0025]); and
stopping centrifugation of the biological sample if the switch is deactivated during the centrifugation duration (par [0025]).
Rust explicitly states that “the centrifuge 20 may include an interlock switch (not shown) that prevents the operation of the centrifuge 20 when the cover 24 is in the open position” (par [0025). This interlock switch is activated when the lid is closed and deactivated when the lid is opened.
Rust discloses a processor (controller 38) electrically coupled to the motor 30 and batteries 36 to control centrifuge operation (par [0030]). The centrifuge operates for a predetermined duration of time and speed (10,000 rpm for 90 seconds) (par [0036]) when the switch is activated (par [0025]). Because the interlock switch disables the motor when opened, centrifugation stops if the switch is deactivated. Thus, Rust teaches the claimed control logic.
Rust does not specifically disclose that wherein the container includes a removable cap defining a primary seal, and a secondary seal between the lid and the housing, wherein the secondary seal is positioned to seal the compartment around the rotor and the container when the lid is in the closed position.
However, Eppendorf discloses that wherein the container includes a removable cap (tube lid) defining a primary seal (page 15), and a secondary seal (rotor lid) between the lid (centrifuge lid) and the housing (page 21), wherein the secondary seal is positioned to seal the compartment around the rotor and the container when the lid is in the closed position (page 21). It would have been obvious to one of ordinary skill in the art to use a removable cap defining a primary seal to seal the container, in order to prevent the leak of the container. And it would have been obvious to one of ordinary skill in the art to use secondary seal between the lid and the housing, wherein the secondary seal is positioned to seal the compartment around the rotor and the container when the lid is in the closed position, in order to prevent the leak of the rotor.
Claim(s) 25-26, 30 and 34-36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rust in view of Eppendorf as applied to claim 24, 27-29, 31-33, 37-39 and 42 above, and further in view of Thermo Scientific (Sorvall RC6 Plus Superspeed Centrifuge Instruction Manual, 2012).
Regarding claim 25, Rust does not specifically disclose that wherein the centrifugation duration is prespecified before shipping of the centrifuge system to the location of the patient.
However, Thermo Scientific discloses that wherein the centrifugation duration is prespecified before shipping of the centrifuge system to the location of the patient (30 program memory) (page 1-2). Rust teaches that the centrifuge is explicitly designed for remote or low-resource areas (par [0024]) where trained personnel may be unavailable.
It would have been obvious to one of ordinary skill in the art to prespecify the centrifuge duration before shipping of the centrifuge system to the location of the patient, in order to simplify the centrifuge operation.
Regarding claim 26, Thermo Scientific discloses that wherein centrifuging the biological sample further includes centrifuging the biological sample at a centrifugation speed, and wherein the centrifugation speed is prespecified before shipping of the centrifuge system to the location of the patient (30 program memory) (page 1-2).
Regarding claim 30, Rust discloses that wherein the cover is positioned to move from the open position to the closed position when the centrifuge assembly centrifuges the biological sample (par [0025]). Automating a process is obvious.
Thermo Scientific discloses that “For safety reasons, the door is automatically locked while the rotor is rotating. The locked state is held even if the instrument power is turned off. The door can be opened/closed only when the rotor stops.” (page 3-6).
Regarding claim 34, Thermo scientific discloses that wherein the centrifuge operations cause centrifuging of the biological sample, via the centrifuge assembly, for the centrifugation duration after expiration of a timer initiated when the switch is activated (The RC6 Plus Superspeed Centrifuge can be programmed to perform automatic centrifugation by setting the incorporated time clock to start and end centrifugation at the desired time in advance) (page 4-14).
Regarding claim 35, Thermo scientific discloses that wherein the timer is prespecified before shipping of the centrifuge system to the location of the patient (page 4-14).
Regarding claim 36, Eppendorf discloses that wherein the timer has a duration selected to ensure that (c) the biological sample has sufficient time to come to a specified temperature (page 23).
Claim(s) 43 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rust in view of Eppendorf as applied to claim 24, 27-29, 31-33, 37-39 and 42 above, and further in view of Gray et al. (Sentinel Level Clinical Laboratory Guidelines for Suspected Agents of Bioterrorism and Emerging Infectious Diseases, 2012) (Gray).
Regarding claim 43, Rust does not specifically disclose a fluid absorbent material positioned between the primary seal and the secondary seal. However, Gray discloses using a fluid absorbent material positioned between the primary seal (primary container) and the secondary seal (secondary container) to prevent the leakage of infectious substances (page 12, par 3). It would have been obvious to one of ordinary skill in the art to use a fluid absorbent material positioned between the primary seal and the secondary seal, in order to prevent the leak of infectious substances.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to XIAOYUN R XU, Ph. D. whose telephone number is (571)270-5560. The examiner can normally be reached M-F 8am-5pm.
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/XIAOYUN R XU, Ph.D./ Primary Examiner, Art Unit 1797