DETAILED 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 .
Amendment Entered
In response to the amendment filed on May 26th, 2026, claims 11-12, 18, and 20 are withdrawn from consideration. Claims 1, 3-10, 13-17, 19, and 32-33 are currently under examination.
Response to Arguments
Applicant's remarks and amendments with respect to the claim objections have been fully considered. The objections are withdrawn in view of the amendment.
Applicant’s arguments with respect to the rejections under 35 U.S.C. 103 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.
Claim Objections
Claims 1, 13, and 19 are objected to because of the following informalities:
Claim 1 recites “a first compartment for holding” in line 3, but should read “a first compartment configured for holding”
Claim 1 recites “a second compartment for holding” in line 10, but should read “a second compartment configured for holding”
Claim 13 recites “causes the second cartridge advance” in line 4, but should read “causes the second cartridge to advance”
Claim 19 recites “cartridges” in line 1, but should read “compartments”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 3-10, 13-17, 19, and 32-33 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “from a tonometer” in line 9 and “to the tonometer” in line 17, and the dependent claims further recite “tonometer” numerous times, notably Claim 15 recites “a cup-like structure configured to mate with the tonometer” in lines 1-2. It is unclear as to whether the “tonometer” is a required element in the system recited by the current claims or not. Clarification is requested.
The term “cup-like” in claim 15 is a relative term which renders the claim indefinite. The term “cup-like” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 6, 8, 13, 15, 17, and 33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ingber et al. (U.S. Publication No. 2011/0093207).
Regarding Claim 1, Ingber discloses a system for managing a plurality of tonometer probes (system for conducting the identification of bacteria in biological samples; Abstract; Examiner’s Note: the recitation “for managing a plurality of tonometer probes” has not been given patentable weight because the recitation occurs in the preamble. A preamble is generally not accorded any patentable weight where it merely recites the purpose of a process or the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the process steps or structural limitations are able to stand alone. See In re Hirao, 535 F.2d 67, 190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187 F.2d 150, 152, 88 USPQ 478, 481 (CCPA 1951)), comprising:
a first compartment for holding contaminated tonometer probes (area that contains centrifuge 31; Examiner’s Note: The Examiner notes wherein the limitation “for holding contaminated tonometer probes” is a recitation of the intended use of the invention. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations), wherein the first compartment has an input port (The gripper 33 a of rotatable gripper mechanism 33 selects the centrifuge tube 18 for transfer from the magazine 26 and into the centrifuge 31. The centrifuge rotor (not shown) is configured to align a vacant centrifuge holder of centrifuge 31 in the load position; [0103]) and is configured to contain a first cylindrical cartridge (cylindrical body of centrifuge 31) that has a central axis and that holds a plurality of tubes (centrifuge tubes 18; [0094-0095]) circularly arranged about the central axis of the cartridge (Figure 6), wherein the tubes of the first cartridge each have an open end configured to receive contaminated tonometer probes (Figure 3B; Examiner’s Note: The Examiner notes wherein the limitation “configured to receive contaminated tonometer probes” is a recitation of the intended use of the invention. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations), wherein the first cartridge is configured to rotate about the central axis such that each of the tubes can be aligned with the input port to receive a contaminated probe from a tonometer (The centrifuge rotor (not shown) is configured to align a vacant centrifuge holder of centrifuge 31 in the load position. The gripper 33 a referred to as a “Theta Z gripper” is a radial member that rotates and has a downward and upward movement for picking up and setting a centrifuge tube 18 into a vacant centrifuge holder of centrifuge 31; [0103]; Examiner’s Note: The Examiner notes wherein the limitation “configured to rotate about the central axis such that each of the tubes can be aligned with the input port to receive a contaminated probe from a tonometer” is a recitation of the intended use of the invention. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations); and
a second compartment for holding clean tonometer probes (area that contains carousel 15; rotatable table 41 supporting the carousel 15…the sample processor 14 also includes a drawer 38 which has a rotatable table 41 which receives, supports, and rotates the magazine 26 when the drawer 38 is inserted into the sample processor 14; [0099]; Examiner’s Note: The Examiner notes wherein the limitation “for holding clean tonometer probes” is a recitation of the intended use of the invention. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations), wherein the second compartment has an output port (a rotatable gripper mechanism 33 which picks up the centrifuge tube 18 (FIGS. 1A and 1B) of each disposable cartridge 12; [0099]) and is configured to contain a second cylindrical cartridge that has a central axis and that holds a plurality of tubes (centrifuge tubes 18; [0094-0095]) circularly arranged about the central axis of the second cartridge (Figure 3A), wherein the tubes of the second cartridge each have an open end configured to dispense clean tonometer probes (Figure 3A; Examiner’s Note: The Examiner notes wherein the limitation “configured to dispense clean tonometer probes” is a recitation of the intended use of the invention. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations), wherein the second cartridge is configured to rotate about the central axis of the second cartridge such that each of the tubes can be aligned with the output port to dispense a clean probe to the tonometer (The drive mechanism of the rotatable table 41 is configured to align the centrifuge tube 18 of each disposable cartridge 12 into position relative to the rotatable gripper mechanism unit 33. The gripper 33 a of rotatable gripper mechanism 33 selects the centrifuge tube 18 for transfer from the magazine 26 and into the centrifuge 31; [0103]; Examiner’s Note: The Examiner notes wherein the limitation “configured to rotate about the central axis of the second cartridge such that each of the tubes can be aligned with the output port to dispense a clean probe to the tonometer” is a recitation of the intended use of the invention. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations);
wherein the first and second compartments are distinct from one another (Examiner’s Note: The carousel 15 and the centrifuge 31 are two separate components that are distinct from one another, as shown in Figure 3A).
Regarding Claim 6, Ingber discloses wherein the first and/or second compartment is moveable to facilitate loading of a cartridge (The sample processor 14 also includes a drawer 38 which has a rotatable table 41 which receives, supports, and rotates the magazine 26 when the drawer 38 is inserted into the sample processor 14; [0099]).
Regarding Claim 8, Ingber discloses an actuator that causes at least one of the first and second cartridges to rotate, such that the rotated cartridge advances to (a) align an empty one of the tubes of the first cartridge with the input port (The centrifuge rotor (not shown) is configured to align a vacant centrifuge holder of centrifuge 31 in the load position. The gripper 33 a referred to as a “Theta Z gripper” is a radial member that rotates and has a downward and upward movement for picking up and setting a centrifuge tube 18 into a vacant centrifuge holder of centrifuge 31; [0103]) or (b) dispense the clean probe into the tonometer via the output port (The drive mechanism of the rotatable table 41 is configured to align the centrifuge tube 18 of each disposable cartridge 12 into position relative to the rotatable gripper mechanism unit 33; [0103]).
Regarding Claim 13, Ingber discloses a first actuator that causes the first cartridge to rotate to align an empty tube of the first cartridge with the input port (The centrifuge rotor (not shown) is configured to align a vacant centrifuge holder of centrifuge 31 in the load position. The gripper 33 a referred to as a “Theta Z gripper” is a radial member that rotates and has a downward and upward movement for picking up and setting a centrifuge tube 18 into a vacant centrifuge holder of centrifuge 31; [0103]); and a second actuator that causes the second cartridge advance to dispense the clean probe into the tonometer via the output port (The drive mechanism of the rotatable table 41 is configured to align the centrifuge tube 18 of each disposable cartridge 12 into position relative to the rotatable gripper mechanism unit 33; [0103]).
Regarding Claim 15, Ingber discloses wherein the output port is a cup-like structure configured to mate with the tonometer to facilitate passage of the clean probe from the second cartridge into the tonometer (a rotatable gripper mechanism 33 which picks up the centrifuge tube 18 (FIGS. 1A and 1B) of each disposable cartridge 12; [0099]; Examiner’s Note: Figures 1B and 2 show wherein the disposable cartridge 12 includes multiple cup-like structures. Furthermore, the Examiner notes wherein the limitation “configured to mate with the tonometer to facilitate passage of the clean probe from the second cartridge into the tonometer” is a recitation of the intended use of the invention. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations).
Regarding Claim 17, Ingber discloses wherein each of the plurality of tubes of the first cartridge has an open end and a portion distal from the open end configured to support one of the contaminated tonometer probes while allowing passage of fluid into or out of the tube (Examiner’s Note: Figure 3B shows wherein each of the tubes has an open end and a portion distal from the open end capable of supporting one of the contaminated tonometer probes while allowing passage of fluid into or out of the tube. Furthermore, the Examiner notes wherein the limitation “configured to support one of the contaminated tonometer probes while allowing passage of fluid into or out of the tube” is a recitation of the intended use of the invention. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations).
Regarding Claim 33, Ingber discloses wherein the first and second compartments are connected to a shared housing (Examiner’s Note: Figure 3A shows wherein the first and second compartments are connected to a shared housing of the sample processor 14).
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.
Claims 3-4, 7, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Ingber et al. in view of Williams (U.S. Patent No. 4,824,641; cited by Applicant; previously cited).
Regarding Claim 3, Ingber discloses wherein the first cartridge is removable from its compartment (The sample processor 14 also includes a drawer 38 which has a rotatable table 41 which receives, supports, and rotates the magazine 26 when the drawer 38 is inserted into the sample processor 14; [0099]).
Ingber fails to specifically teach wherein the second cartridge is removable from its compartment.
In a similar technical field, Williams discloses an improved sample carrier and pipette tips for use in an automated sample handling device (Abstract), wherein the first and second cartridges are removable from their respective compartments (This carrier is removable from the carousel and has spaced about the circumference of its body a plurality of apertures for receiving the sample containers; Column 2 Lines 40-43; Carrier 15 rests on and is carried by carousel 14. Carrier 15 is constructed of two pieces of plastic material, a bottom 204 and a top 205; Column 5 Lines 27-29).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the carousel and carrier teachings of Williams into the invention of Ingber in order to ensure that the cartridge is removable, as removable parts enable better maintenance practices, which lead to overall improved performance and quality.
Regarding Claim 4, although Ingber discloses wherein the first and second compartments are connected to a shared housing (Examiner’s Note: Figure 3A shows wherein the first and second compartments are connected to a shared housing of the sample processor 14), Ingber fails to disclose wherein: the first compartment is an upper compartment; the second compartment is a lower compartment the upper compartment is above the lower compartment; and the upper and lower compartments are each openable to receive a cartridge.
In a similar technical field, Williams discloses an improved sample carrier and pipette tips for use in an automated sample handling device (Abstract), wherein: the first compartment is an upper compartment (sample carrier 15); the second compartment is a lower compartment (carousel 14) the upper compartment is above the lower compartment (See Figure 1); and the upper and lower compartments are each openable to receive a cartridge (sample carrier 15 is configured to contain top 205 and carousel 14 is configured to contain bottom 204).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the configuration teachings of Williams into the invention of Ingber, as a vertical configuration would save more space compared to a horizontal configuration.
Regarding Claim 7, although Ingber discloses wherein the first and second compartments are connected to a shared housing (Examiner’s Note: Figure 3A shows wherein the first and second compartments are connected to a shared housing of the sample processor 14), Ingber fails to disclose wherein the central axis of the first cartridge is in alignment with the central axis of the second cartridge.
In a similar technical field, Williams discloses an improved sample carrier and pipette tips for use in an automated sample handling device (Abstract), wherein the central axis of the first cartridge is in alignment with the central axis of the second cartridge (See Figures 1-2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the configuration teachings of Williams into the invention of Ingber, as a vertical configuration with an aligned central axis would save more space compared to a horizontal configuration.
Regarding Claim 14, Ingber fails to disclose an actuator that causes the first and second cartridges to rotate in unison, such that the first cartridge advances to align an empty tube of the first cartridge with the input port and the second cartridge advances to dispense the clean probe into the tonometer via the output port.
In a similar technical field, Williams discloses an improved sample carrier and pipette tips for use in an automated sample handling device (Abstract), comprising an actuator that causes the first and second cartridges to rotate in unison (The automatic traversing of the pipette, the rotation of the carousel to bring samples into alignment, and the pick up of the tips by the pipette is subject to the usual variations common with mechanical devices…knob 206. The knob also provides a convenient handle for lifting and manipulating the carrier. This arrangement allows the edge of the top 205 to resiliently move upwards and downwards relative to the bottom 204. The bottom 204 has registration means 207 for engaging a raised section 202 of carousel 14 so that when the carousel moves it also moves the carrier; Column 5 Lines 21-40), such that the first cartridge advances to align an empty tube of the first cartridge with the input port and the second cartridge advances to dispense the clean probe into the tonometer via the output port (FIG. 1 also shows a rotatable carousel 14 which can serially bring a plurality of analytical sample containers such as test tubes 16A, 16B and 16C or the like carried by sample carrier 15 into position for processing by the carriage and transfer to assay trays carried on table 12; Column 4 Lines 33-38; Examiner’s Note: Although these input and output ports are not directly recited, the invention of Williams is capable of rotating the carousel and carrier to align with a designated input/output port).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the actuator teachings of Williams into the invention of Ingber in order to enable both cartridges to simultaneously align, instead of having two separate processes for each cartridge.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Ingber et al. in view of Mariotti et al (U.S. Patent No. 7,708,938; cited by Applicant; previously cited).
Regarding Claim 16, Ingber fails to disclose an indicator that signals that the first cartridge is full or that the second cartridge is empty.
In a similar technical field, Mariotti discloses a method and device for measuring and controlling the circulation of fluids in endoscope channels (Abstract), comprising an indicator that signals that the first cartridge is full (As soon as the high level sensor N2 indicates that the chamber is full, the action is maintained for a waiting time equal to half the filling time; Column 5 Lines 48-51) or that the second cartridge is empty (a timing is performed until the low level sensor N1 indicates that the chamber 12 is empty; Column 5 Lines 63-64).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the indicator teachings of Mariotti into the invention of Ingber in order to control filling and emptying of the chambers during the cleaning and disinfection process of medical equipment (Mariotti Column 3 Lines 11-26).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Ingber et al. in view of Wallock et al (U.S. Patent No. 5,308,406; previously cited).
Regarding Claim 19, although Ingber discloses wherein the first and second cartridges are connected to a housing (Examiner’s Note: Figure 3A shows wherein the first and second cartridges are connected to a shared housing of the sample processor 14), Ingber fails to disclose wherein the housing is a wall-mountable housing.
In a similar technical field, Wallock teaches a method for cleaning soiled health care instruments (Abstract), wherein the housing is a wall-mountable housing (If preferred, the device 9 may be mounted on a bracket 53 (FIG. 5). For this purpose the bracket 53 may have a platform 54 on which the device 9 is received, a mounting back 55 secured to a stand or wall 57; Column 5 Lines 34-38; Figure 5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the mounting teachings of Wallock into the invention of Ingber in order to allow the device to be located at a height sufficient to permit easy insertion of the health care instruments as well as easily snapped in or removed when it is desired to clean (Wallock Column 5 Lines 34-60).
Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over Ingber et al. in view of Lesic et al (U.S. Publication No. 2015/0128997; previously cited).
Regarding Claim 32, Ingber fails to disclose a push button that causes the first or second cartridge to rotate.
In a similar technical field, Lesic teaches a cleaning device and methods for cleaning medical devices (Abstract), comprising a push button that causes the first or second cartridge to rotate (pressing a button or switch applies power to an electrical motor, which when powered on, causes rotation of at least one of the first axis and the second axis; [0069]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the button teachings of Lesic into the invention of Ingber, as such a system has the added potential benefit of being “hands-free” and potentially gives the care-giver the option of using one hand for other activities, while using his/her first hand to apply the medical device to the device cleaning apparatus (Lesic [0070]).
Allowable Subject Matter
Claims 5 and 9-10 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHANEL J YOON whose telephone number is (571) 272-2695. The examiner can normally be reached on Monday-Friday 9:00AM-5:00PM.
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/CHANEL J YOON/Examiner, Art Unit 3791