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 .
Claim Objections
The claims contain minor informalities.
In claims 1 and 22, the language “… a secondary vacuum level detection system for monitoring the vacuum level in the first container.” should be changed for clarity.
In claim 4, the language “… a safety transducer for monitoring the suction level generated by the vacuum pump …” should be changed for clarity.
In claim 23, the language “… controlling a suction level generated in the canister with [[of]] the vacuum pump with a suction regulator … monitoring the suction level generated in the canister …” should be changed for clarity.
Claim Rejections - 35 USC § 112(b)
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 14-16, 19 and 20 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 pre-AIA the applicant regards as the invention.
Claim 14 calls for “…wherein: the flange extends in a first circumferential direction; and the groove extends in a second circumferential direction opposite the first circumferential direction.”
This language is ambiguous because any circular object generally has one outer perimeter that defines its circumference, and the claim does not explain how to compare two perimeters. The specification does not describe “circumferential” directions and instead describes an interlocking flange and groove (¶ [0116], The flange 66 maybe configured to engage a groove 70 of or on an interior portion 25b of the lid ring 25; ¶ [0120] The interior portion 25b of the lid ring 25 may include flange openings 80 for receiving flanges of lid 24 in a groove 70 of the lid ring 25 to create a twist lock connection between the lid 24 and the lid ring 25 … Additionally, due to the groove 70 having a cam surface 82 and the flange 66 having a ramped surface). Here, the specification implies that the flange and groove do not extend in opposite directions, but rather that their angles closely match or correspond with each other. Examiner suggests to rephrase this feature in terms of matching “lead angles” or “helix angles.”
Claim 19 calls for “… and a groove positioned in the lid ring adjacent the groove.” This language is ambiguous since it describes the groove as being adjacent to itself. Parent claims 13 and 17 do not describe any groove that can be compared to claim 19 and the lid ring’s groove.
Examiner suggests to revise this feature to describe the groove’s location relative to a different structure, such as near the lid ring’s inner surface or top surface.
Claims 15, 16 and 20 are rejected for depending on a rejected parent claim.
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 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) NOVELTY; PRIOR ART.—A person shall be entitled to a patent unless—
(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; or
Claims 1-3, 11 and 23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lalomia; Brent S. et al. (US 20070135779 A1).
Regarding claim 1, Lalomia discloses a fluid waste container assembly (¶ [0002], a waste collection and disposal system; ¶ [0014], [0111], FIG. 1, the system 100);
comprising: a first container (¶ [0113] Referring to FIG. 2, the waste collection unit 102 utilizes upper 200 and lower 202 waste containers to collect and temporarily store the waste material during use; ¶ [0115], FIGS. 2 and 3, the upper waste container 200 comprises an upper canister 218 … The lower waste container 202 comprises a lower canister 224);
a base forming a bottom for the first container, the base having an interior surface at least partially defining a drain opening (¶ [0118], FIG. 3 … Each of the canisters 218, 224 includes a bottom 230, 232, respectively);
a lid assembly providing selective access to an interior of the first container (¶ [0115], FIGS. 2 and 3 … An upper cap 222 covers the upper canister 218 … A lower cap 228 covers the lower canister 224);
a vacuum pump for producing suction in the first container (¶ [0136] Referring to FIGS. 6 and 17 … In some embodiments, the vacuum source 402 is a rotary vane type vacuum pump 402);
a primary vacuum level detection system for setting a vacuum level in the first container by controlling output of the vacuum pump (¶ [0138], FIG. 17, upper 408 and lower 410 vacuum regulators are included in the vacuum circuit 400 … A first actuator 414 is operatively coupled to the first valve member 412 to move the first valve member 412 and selectively open fluid communication or air transfer between the upper waste container 200 and atmospheric pressure A or between the upper waste container 200 and the vacuum pump 402); and
a secondary vacuum level detection system for monitoring vacuum level in the first container (¶ [0141] Separate sets of pressure sensors 424, 426 are responsive to pressure changes in each of the waste containers 200, 202. The pressure sensors 424, 426 generate corresponding pressure signals sent to the vacuum controllers 411, 413).
To clarify, Lalomia’s upper waste container 200 and its associated base, lid and detection systems are interpreted as analogous to the claimed first container.
Regarding claims 2, 3 and 11, Lalomia discloses a fluid waste container assembly wherein the primary vacuum level detection system comprises a suction regulator for regulating operation of the vacuum pump; further comprising a valve connected to the suction regulator that is configured to constrict a flow path between the vacuum pump and the first container (¶ [0138], FIG. 17, upper 408 and lower 410 vacuum regulators are included in the vacuum circuit 400 … The upper vacuum regulator 408 comprises a first valve member 412. A first actuator 414 is operatively coupled to the first valve member 412 to move the first valve member 412 and selectively open fluid communication or air transfer between the upper waste container 200 and atmospheric pressure A or between the upper waste container 200 and the vacuum pump 402; ¶ [0286] Alternative suction regulator assemblies … Each regulator assembly includes a first valve member that is adjustable to regulate the suction draw from the vacuum source 402);
further comprising: a second container fluidly connected to the vacuum pump (¶ [0115] Referring to FIGS. 2 and 3 … The lower waste container 202 comprises a lower canister 224 … The lower canister 224 defines a lower waste chamber 226 for holding waste material);
an additional primary vacuum level detection system for setting a vacuum level in the second container by controlling the vacuum pump; and an additional secondary vacuum level detection system for monitoring vacuum level in the second container (¶ [0140] The main controller 342 controls operation of the vacuum regulators 408, 410 through upper 411 and lower 413 vacuum controllers (e.g., separate microcontrollers)).
Regarding claim 23, Lalomia discloses all the claimed structures including a canister, vacuum pump, user input, suction regulator and safety transducer, as discussed for claim 1 above. Lalomia operates these structures in the same manner as discussed for claim 1, by automatically adjusting the suction regulator to match the suction level in the canister to the desired suction level based on output of the safety transducer (¶ [0141] Separate sets of pressure sensors 424, 426 are responsive to pressure changes in each of the waste containers 200, 202. The pressure sensors 424, 426 generate corresponding pressure signals sent to the vacuum controllers 411, 413).
Claim Rejections - 35 USC § 103
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 4-6 are rejected under 35 U.S.C. 103 as being unpatentable over Lalomia; Brent S. et al. (US 20070135779 A1) in view of Gordon; Benjamin et al. (US 20130150813 A1).
Regarding claim 4, Lalomia discloses that the secondary vacuum level detection system comprises a safety transducer for monitoring suction level generated by the vacuum pump (¶ [0141] Separate sets of pressure sensors 424, 426 are responsive to pressure changes in each of the waste containers 200, 202. The pressure sensors 424, 426 generate corresponding pressure signals sent to the vacuum controllers 411, 413).
Lalomia does not locate the safety transducer between the valve and the vacuum pump. Gordon discloses methods and devices for topical negative pressure (TNP) therapy (¶ [0003], [0029], [0163], FIG. 1 … apparatus 10);
comprising a vacuum pump (¶ [0164], The device unit 32 comprises an aspirant pump 44, an aspirant pressure monitor 46 and an aspirant flowmeter 48 operably connected together; ¶ [0214] FIG. 20C shows a third embodiment where two pressures sensors 2040, 2042 are placed upstream of the pump 44 and between the pump 44 and flow restriction 2002; ¶ [0216] FIG. 20E shows a schematic diagram of a fifth embodiment where a flow restrictor 2002 is placed downstream of the pump 44 and which has pressure sensors 2060, 2062 placed either side as in FIG. 10); and
a safety transducer for monitoring suction level generated by the vacuum pump, wherein the safety transducer comprises a sensor located between a valve and the vacuum pump (¶ [0214] FIG. 20C shows a third embodiment where two pressures sensors 2040, 2042 are placed upstream of the pump 44 and between the pump 44 and flow restriction 2002; ¶ [0216] FIG. 20E shows a schematic diagram of a fifth embodiment where a flow restrictor 2002 is placed downstream of the pump 44 and which has pressure sensors 2060, 2062 placed either side as in FIG. 10).
Gordon measures both a pressure and flow through a tubing segment by measuring and comparing pressures on the valve’s upstream and downstream sides (¶ [0212], When the pressure difference between sensors 2004, 2006 falls below a critical value stored in the memory of the control system 60 the control system recognizes this condition as a "blockage" and/or "canister full" condition and triggers a visual and/or audible alarm (not shown); ¶ [0215], When aspirant fluid flow through the restrictor 2002 falls to zero due to a full canister or blocked conduit, the two pressure sensors 2050, 2052 will both have the same reading albeit both reading a negative pressure as the pump is still running. Thus, equal or pressure signals less than a stored difference to the control system 60 will result in the alarm being activated). One would be motivated to modify Lalomia with Gordon’s paired pressure sensors to detect a blocked fluid path. Therefore, it would have been obvious to modify Lalomia with Gordon’s extra pressure sensor in order to detect a blocked fluid path.
Regarding claims 5 and 6, Lalomia discloses an assembly further comprising: a user input for allowing a user to set a suction level to be generated by the vacuum pump and controlled by the suction regulator; and a controller for comparing output of the primary vacuum level detection system to the suction level set via the user input (¶ [0136] Referring to FIGS. 6 and 17, the vacuum circuit 400 provides independently controllable vacuum levels in each of the waste containers 200, 202. As a result, the user can establish different vacuum levels for the waste containers 200, 202 depending on the particular needs of the medical procedure being performed);
wherein the user input is configured to adjust a constriction of the flow path produced by the valve (¶ [0138], A first actuator 414 is operatively coupled to the first valve member 412 to move the first valve member 412 and selectively open fluid communication or air transfer between the upper waste container 200 and atmospheric pressure A or between the upper waste container 200 and the vacuum pump 402).
Claims 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Lalomia and Gordon in view of Karpowicz; John et al. (US 20070219532 A1).
Regarding claims 7 and 9, Lalomia and Gordon do not describe that if the monitored suction level exceeds the suction level, the controller provides an alarm or shuts down the vacuum pump. Karpowicz discloses a negative pressure wound treatment system comprising a controller (¶ [0002], [0015], [0047] FIG. 1 shows an embodiment of a system (10); ¶ [0084], FIG. 6, the portable pump unit (102) preferably includes a positive displacement air pump (103) … a pump unit controller (200); ¶ [0086], FIG. 6, the pump unit controller (200) includes a vacuum or suction pressure controller (202) for maintaining a negative pressure in the wound);
wherein the controller is configured to provide a user-perceptible alarm if a monitored suction level exceeds a desired suction level (¶ [0113], A compliance indicator (236) alerts the caregiver to deviations from the normal application of suction to the wound over time and is a useful adjunct to the application of negative pressure wound therapy; ¶ [0116], The error indicator (234) preferably includes an alphanumeric error display, and the error detector (216) can cause the error display to provide indications that correlate to at least following errors: overpressure (i.e., suction exceeding a prescribed limit), missing waste collector, pressure transducer failure);
wherein the controller is configured to shut-down operation of a vacuum pump if the monitored suction level exceeds the desired suction level (¶ [0088], Once the upper control limit is reached, the pressure controller (202) turns off the pump (103)).
Karpowicz explains details of how to automatically operate a suction pump for a NPWT system. One would be motivated to modify Lalomia and Gordon with Karpowicz’s controller configuration that sends an alarm or shuts down the pump in order to operate the system with minimal user intervention since Lalomia calls for other semi-autonomous operations (¶ [0131] In some instances, the main controller 342 may automatically instruct the valve controller 344 to move the transfer valve 276 without requiring user instruction; ¶ [0224], In some embodiments, this "automatic" mode of smoke evacuation may be set by the user on the control panel 310 or can be continuously operating). Therefore, it would have been obvious to modify Lalomia and Gordon with Karpowicz’s controller configuration in order to automatically regulate the system’s pressure and also to prevent the pump from generating unsafe pressures.
Regarding claim 8, Lalomia discloses that the controller is configured to adjust the valve to match the monitored suction level to the suction level set by the user (¶ [0138], A first actuator 414 is operatively coupled to the first valve member 412 to move the first valve member 412 and selectively open fluid communication or air transfer between the upper waste container 200 and atmospheric pressure A or between the upper waste container 200 and the vacuum pump 402).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Lalomia and Gordon in view of Reasoner; Stephen J et al. (US 20150224237 A1).
Regarding claim 10, Lalomia further discloses an evacuation station (¶ [0111] Referring to FIG. 1, the system 100 comprises a mobile waste collection unit 102 and a fixed docking station 104).
Lalomia and Gordon lack a communication interface and wireless protocol. Reasoner discloses medical waste collection systems (¶ [0001], [0005], [0064], FIGS. 1-4 … system 50; ¶ [0190] FIGS. 26 and 28, waste collection system 3000);
comprising an evacuation station and controller (¶ [0190], chassis 3100 … Chassis 3100 is sometimes called a suction cart 3100; ¶ [0214], Electrical cable 3812 connects data contacts 3510 to a chassis controller 3802 (FIG. 44));
comprising a communication interface operatively connected to the controller for communicating with the evacuation station over a wireless protocol (¶ [0293] Controller 3802 is further in communication with a radio frequency identification device (RFID) reader 3830 via a power and data cable 3832).
Reasoner automatically identifies the system’s various accessories (¶ [0293], The RFID reader 3830 reads information from RFID tags placed on various pieces of medical equipment … RFID tags are placed on surgical handpieces 62, 66). One would be motivated to modify Lalomia and Gordon with Reasoner’s communication interface and wireless protocol to automatically identify accessories used with the Lalomia’s fluid waste container assembly. For example, Lalomia calls for recording data related to the containers (¶ [0202] In the preferred embodiment, an upper memory device 720 is coupled to the upper waste container 200 and a lower memory device 722 is coupled to the lower waste container 202 … The data stored in each memory device 720, 722 is unique to that specific container 200, 202 for which it is coupled to). Therefore, it would have been obvious to modify Lalomia and Gordon with Reasoner’s RFID interface in order to identify the containers or other components used with the fluid waste container assembly.
Claims 12-20 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Lalomia; Brent S. et al. (US 20070135779 A1) in view of Zalewski; Kevin J. (US 20060163252 A1).
Regarding claims 12 and 13, Lalomia further discloses a lid assembly comprising: a lid ring having a central opening, the lid ring engaging a top end of the first container (¶ [0118] Referring specifically to FIG. 3 … A V-clamp 254, 256, respectively, secures the caps 222, 228 to the canisters 218, 224 by clamping the peripheral lips 250, 252 to the rims 238, 240; ); and
a lid configured for engaging the lid ring, the lid being configured to close off at least part of the top end of the first container when engaging the lid ring (¶ [0115], An upper cap 222 covers the upper canister 218 to close the upper waste chamber 220).
Lalomia does not explicitly disclose a twist lock mechanism. Zalewski discloses a molded plastic container comprising a container and a lid assembly (¶ [0001], [0004], [0016], FIG. 1, a container 10 … comprises a cylindrical pail 12 … and a closure or lid 16);
further comprising a lid assembly comprising: a lid ring having a central opening, the lid ring engaging a top end of the first container (¶ [0016], a ring section 14 which is separately formed … Once installed, the ring section 14 provides an annular portion 15 with thread and lock segments); and
a lid configured for engaging the lid ring via a twist lock mechanism, the lid being configured to close off at least part of the top end of the first container when engaging the lid ring (¶ [0019], FIGS. 5-7, the lid 16 incorporates an integrated twist grip 34 … At least one internal thread 42 and a corresponding number of detents 44 (best seen in FIG. 1) close and lock the lid 16 and are complementary to the external threads 26 and detents 28, respectively, of the ring section 14).
Zalewski enables a user to more easily open a container and also prevents dripping when the container is opened (¶ [0020] In operation, the container 10, when closed, can be shaken to mix the contents without fear of leakage. It is easily opened by rotation of the lid 16 … If any excess paint runs over the spout 22, it will fall into the recess 32 between the spout 22 and the threaded portion 15, where it is trapped. It has no adverse effect on the threads). One would be motivated to modify Lalomia with Zalewski’s twist lock mechanism so that a user can open and close the container more easily and with less risk of dripping. Therefore, it would have been obvious to modify Lalomia with Zalewski’s twist lock mechanism in order to reduce the effort needed to open and close the container and to minimize dripping.
Regarding claims 14-20, Lalomia lacks a twist lock mechanism. Zalewski discloses a container wherein the twist lock mechanism comprises: a flange on the lid ring (¶ [0016], Once installed, the ring section 14 provides an annular portion 15 with thread and lock segments); and
a groove on the lid (¶ [0019], At least one internal thread 42 and a corresponding number of detents 44 (best seen in FIG. 1) close and lock the lid 16 and are complementary to the external threads 26 and detents 28, respectively, of the ring section 14);
wherein: the flange extends in a first circumferential direction; and the groove extends in a second circumferential direction opposite the first circumferential direction (¶ [0019], At least one internal thread 42 and a corresponding number of detents 44 … close and lock the lid 16);
wherein: the flange includes a ramp surface (Fig. 1, external thread 26 has an angled or helical shape); and
the groove includes a cam surface (Fig. 1, internal thread 42 also has an angled or helical shape);
wherein the ramp surface and the cam surface frictionally engage when the lid is twisted to lock the lid to the lid ring (¶ [0019], At least one internal thread 42 and a corresponding number of detents 44 … are complementary to the external threads 26 and detents 28, respectively);
wherein the flange includes a stop to prevent further rotation of the lid once the lid is locked into place relative to the lid ring (¶ [0018], The thread 26 incorporates a
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number of detents 28 that snap to lock in order to ensure closure between the ring section 14 and lid 16);
wherein the lid ring comprises: a base configured to face the lid (Figs. 1-3, ring section 14 has a lower wall that faces the lid);
a wall extending from the base, the wall configured to be inserted into the lid (¶ [0018], The crescentoid spout 22 provides a flexible top edge 24 which seals against the inside of the lid 16 when screwed into place); and
a flange extending along the wall to form a first portion of the twist lock mechanism (¶ [0018], The threaded portion 15 of the ring section 14 has at least one external thread 26 to receive the lid 16);
wherein the flange comprises: an elongate projection extending at an angle along the wall; and a vertical portion extending form the elongate projection to connect to the base (Fig. 2, external thread 26 has an angled elongate portion and vertical portions);
wherein the lid ring comprises: a central opening and a top surface surrounding the central opening (Figs. 1-3, ring section 14 has a central opening and top and bottom surfaces);
a flange opening extending into the top surface; and a groove positioned in the lid ring adjacent the groove (Figs. 1-3, ring section 14 has external thread 26, which includes a flange opening and groove);
wherein: the flange is configured to be positioned in the flange opening when the lid is unlocked; and the flange is configured to be positioned in the groove when the lid is locked (¶ [0019], At least one internal thread 42 and a corresponding number of detents 44 … are complementary to the external threads 26 and detents 28, respectively).
Zalewski does not disclose a flange, base and wall on the lid and a groove on the lid ring. Instead, Zalewski switches the arrangement of the flange and groove. However, Zalewski otherwise discloses an interlocking flange and groove that secures the lid to the lid ring. Reversing the locations of these components does not necessarily provide patentability since they operate in the same way whether they are located on the flange or lid.
Zalewski’s twist lock mechanism allows the container to be opened more easily and also prevents dripping when the container is opened (¶ [0020]). Regarding the rationale and motivation to modify Lalomia with Zalewski’s twist lock mechanism, see the discussion of claim 12 above.
Regarding claim 22, Lalomia further discloses a vacuum pump for producing suction in the container (¶ [0136] Referring to FIGS. 6 and 17 … In some embodiments, the vacuum source 402 is a rotary vane type vacuum pump 402);
a primary vacuum level detection system for setting a vacuum level in the container by controlling output of the vacuum pump (¶ [0138], FIG. 17, upper 408 and lower 410 vacuum regulators are included in the vacuum circuit 400 … A first actuator 414 is operatively coupled to the first valve member 412 to move the first valve member 412 and selectively open fluid communication or air transfer between the upper waste container 200 and atmospheric pressure A or between the upper waste container 200 and the vacuum pump 402); and
a secondary vacuum level detection system for monitoring vacuum level in the container (¶ [0141] Separate sets of pressure sensors 424, 426 are responsive to pressure changes in each of the waste containers 200, 202. The pressure sensors 424, 426 generate corresponding pressure signals sent to the vacuum controllers 411, 413).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Lalomia and Zalewski in view of Romano, Jack W. et al. (US 20050215961 A1).
Regarding claim 21, Lalomia and Zalewski lack a door and living hinge. Romano discloses a medical waste fluid collection container comprising a lid assembly including a door providing access to the container through the lid, wherein a living hinge connects the door to the lid (¶ [0105] FIG. 20 … The locking and sealing between lid 10 and canister 7 is maintained by first, second, third and fourth snap down locks 10i turned down and remaining in integral contact with lid 10 by a living hinge; ¶ [0151] FIG. 8j is a front elevation view of lid 10 disclosing details lever hook 10h, living hinge 10u, cap nest sunken detent 10a1, pivot socket 10f, lid fenestration 10d, pivot socket distraction ramp/roof 10e2, lid fenestration 10a, sealing surface 10n, lid rim 10k, living hinge 10u an lid side wall 10j).
Romano provides additional openings and closures on a waste collection container for adding or removing materials. One would be motivated to modify Lalomia and Zalewski with Romano’s door and living hinge so that other materials can be added or removed to the container without removing its lid.
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1-6, 10-16 and 19-23 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 14-17 and 19-22 of Smith ‘242; Larry C. et al. (US 10940242 B2).
Regarding pending claim 1, Smith ‘242 claims all limitations in patented claim 19, namely a fluid waste container assembly (claim 19, a fluid waste container assembly);
comprising: a first container (claim 19, a container);
a base forming a bottom for the first container (claim 19, a base forming a bottom for the container);
the base having an interior surface at least partially defining a drain opening (claim 19, the base having a crescent-shaped interior surface at least partially defining a drain opening);
a lid assembly providing selective access to an interior of the first container (claim 19, a lid assembly providing selective access to an interior of the container);
a vacuum pump for producing suction in the first container (claim 19, a vacuum pump for producing suction in the container);
a primary vacuum level detection system for setting a vacuum level in the first container by controlling output of the vacuum pump (claim 19, a suction regulator for regulating operation of the vacuum pump; a user input for setting a suction level to be generated by the vacuum pump and controlled by the suction regulator); and
a secondary vacuum level detection system for monitoring vacuum level in the first container (claim 19, a vacuum level detection system for sensing a vacuum level generated by the vacuum pump; and a controller for comparing output of the vacuum level detection system the suction level set via the user input).
Regarding pending claim 13, Smith ‘242 claims all limitations in patented claim 14, namely a medical waste fluid collection container assembly (claim 14, a medical waste fluid collection container assembly);
comprising: a container having a first end and a second end (claim 14, a container extending along a central axis; the container comprising: a first end; a second end located axially above the first end);
a base positioned at the first end of the container, the base forming a bottom having a drain opening (claim 14, a base enclosing the first end of the container, the base comprising: … a drain opening located proximate the two pointed ends); and
a lid assembly, comprising: a lid ring having a central opening, the lid ring engaging the second end of the container (claim 14, a lid assembly, comprising: a lid ring having a central opening, the lid ring engaging the second end of the container); and
a lid configured for engaging the lid ring via a twist lock mechanism (claim 14, a lid configured for engaging the lid ring via a twist lock mechanism wherein circumferential rotation of the lid engages flanges of the lid with grooves of the lid ring);
the lid being configured to close off at least part of the second end of the container when engaging the lid ring (claim 14, the lid being configured to cover at least part of the central opening when engaging the lid ring).
Regarding pending claim 23, Smith ‘242 claims substantially all limitations in patented claims 19 and 20, namely a medical fluid waste container comprising a canister (claim 19, a fluid waste container assembly, comprising: a container);
a vacuum pump (claim 19, a vacuum pump for producing suction in the container);
setting a desired suction level within the canister via a user input (claim 19, a controller for comparing output of the vacuum level detection system the suction level set via the user input);
controlling a suction level generated in the canister with the vacuum pump with a suction regulator (claim 19, a controller for comparing output of the vacuum level detection system the suction level set via the user input);
monitoring suction level generated in the canister with a safety transducer (claim 20, further comprising a safety transducer for monitoring suction level generated by the vacuum pump in tubing connected to the vacuum pump); and
automatically adjusting the suction regulator to match the suction level in the canister to the desired suction level based on output of the safety transducer (claim 19, a suction regulator for regulating operation of the vacuum pump; a user input for setting a suction level to be generated by the vacuum pump and controlled by the suction regulator).
Smith ‘242 does not explicitly claim a method of controlling suction level in a medical fluid waste container. However, Smith ‘242 claims all the structures necessary to perform these methods. During routine operation, Smith ‘242’s system will perform all the steps of the claimed method.
Regarding the step of automatically adjusting the suction regulator, Smith ‘242 claims a regulator (claim 19, a suction regulator for regulating operation of the vacuum pump; a user input for setting a suction level to be generated by the vacuum pump and controlled by the suction regulator). Setting a desired level and regulating the vacuum pump implies that the regulator adjusts the pump’s operation until the desired suction level is achieved.
Regarding pending claim 6, Smith ‘242 does not explicitly claim that the user input adjusts the valve’s constriction. However, any valve necessarily operates by selectively opening or adjusting its effective cross-section.
Regarding pending claim 11, Smith ‘242 does not explicitly claim a second container, additional primary vacuum level detection system or an additional secondary vacuum level detection system.
These limitations are interpreted as a duplication of parts, which does not provide patentability unless a new and unexpected result is produced. One would have been motivated to duplicate Smith ‘242’s container and primary / secondary detection systems in order to expand the assembly’s general capacity or to provide a backup system. Duplicating the container and detection systems will double the volume of fluids that the system can collect, and will also allow it to continue operating if one of the two containers or their detection systems fails. Therefore, a new and unexpected result would not be produced by duplicating the container and detection systems. See MPEP 2144.04 (VI)(B).
Regarding pending claims 2-5, 10, 12, 14-16 and 19-22, Smith ‘242 claims all limitations in patented claims 14-17 and 19-22 as shown in table 1.
Table 1: Smith ‘242 double patenting
Pending claim
Smith ‘242
Pending claim
Smith ‘242
Pending claim
Smith ‘242
2
19
12
19, 14
20
14
3
22
14
14
21
17
4
20
15
15
22
14, 19
5
19
16
16
10
21
19
14
Claims 7-9 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims of Smith ‘242; Larry C. et al. (US 10940242 B2) in view of Karpowicz; John et al. (US 20070219532 A1).
Regarding pending claims 7 and 9, Smith ‘242 does not explicitly claim that the controller provides a user-perceptible alarm or shuts down the vacuum pump.
Karpowicz discloses a negative pressure wound treatment system comprising a controller (¶ [0002], [0015], [0047] FIG. 1 shows an embodiment of a system (10); ¶ [0084], FIG. 6, the portable pump unit (102) preferably includes a positive displacement air pump (103) … a pump unit controller (200); ¶ [0086], FIG. 6, the pump unit controller (200) includes a vacuum or suction pressure controller (202) for maintaining a negative pressure in the wound);
wherein the controller is configured to provide a user-perceptible alarm if a monitored suction level exceeds a desired suction level (¶ [0113], A compliance indicator (236) alerts the caregiver to deviations from the normal application of suction to the wound over time and is a useful adjunct to the application of negative pressure wound therapy; ¶ [0116], The error indicator (234) preferably includes an alphanumeric error display, and the error detector (216) can cause the error display to provide indications that correlate to at least following errors: overpressure (i.e., suction exceeding a prescribed limit), missing waste collector, pressure transducer failure);
wherein the controller is configured to shut-down operation of a vacuum pump if the monitored suction level exceeds the desired suction level (¶ [0088], Once the upper control limit is reached, the pressure controller (202) turns off the pump (103)).
Karpowicz explains details of how to automatically operate a suction pump for a NPWT system. One would be motivated to modify Smith ‘242’s claims with Karpowicz’s controller configuration that sends an alarm or shuts down the pump in order for the system to operate with minimal user intervention. Therefore, it would have been obvious to modify Smith ‘242’s claims with Karpowicz’s controller configuration in order to automatically regulate the system’s pressure and also to prevent the pump from generating unsafe pressures.
Regarding pending claim 8, Smith ‘242 does not explicitly claim that the controller adjusts the valve to match the monitored suction level to the suction level set by the user. However, Smith ‘242 claims a user input and suction regulator (claim 19, a user input for setting a suction level to be generated by the vacuum pump and controlled by the suction regulator). This implies that the regulator adjusts the valve in order to seek the desired pressure level.
Claims 17 and 18 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims of Smith ‘242; Larry C. et al. (US 10940242 B2) in view of Farrar; Peter Antony et al. (US 20080257849 A1).
Regarding pending claims 17 and 18, Smith ‘242 does not claim a base, wall or flange. Farrar discloses a beverage container (¶ [0006], [0043] FIG. 1 shows two containers, 1a and 1b; ¶ [0059] FIG. 10 shows a further embodiment of a beverage container according to the invention);
comprising a lid and twist lock mechanism (¶ [0059] FIG. 10 … a container body 53 having a wide-mouth opening 54 and a cap 55 … to close the opening.);
wherein the lid comprises: a base capable of facing a lid ring (¶ [0044], skirt portion 3a);
a wall extending from the base, the wall configured to be inserted into the lid ring (¶ [0045], bore plug 25 of the cap 3; ¶ [0052], plug portion 513 of the cap 55); and
a flange extending along the wall to form a first portion of the twist lock mechanism (¶ [0052], a plug portion 513 of the cap 55 includes a screw thread 515 on its external surface; ¶ [0059], The thread 515 shown in FIG. 10 is similar to the thread 515 shown in FIG. 9, but with the third regions C omitted, such that the thread 515 of the cap comprises only first and second regions A and B. In this embodiment, therefore, the thread 515 is substantially a bayonet thread comprising an inclined axially-extending region B and a circumferentially-extending region A);
wherein the flange comprises: an elongate projection extending at an angle along the wall; and a vertical portion extending form the elongate projection to connect to the base (Fig. 10, thread 515 comprises an elongate angled portion and a vertical portion that extends upward towards the cap’s skirt portion).
Farrar describes details of a twist-lock or bayonet connection for a container and lid. A skilled artisan would have been able to modify Smith ‘242’s claims with Farrar’s base, wall, flange and projection by adding these features to Smith ‘242’s claims. One would be motivated to modify Smith ‘242’s claims with Farrar’s twist lock features since Smith ‘242 requires a twist lock mechanism but is silent regarding its details (claim 14, a lid configured for engaging the lid ring via a twist lock mechanism). Therefore, it would have been obvious to modify Smith ‘242’s claims with Farrar’s twist lock features in order to fully construct Smith ‘242’s twist lock mechanism.
Claims 1, 2 and 11 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1, 2 and 4 of Smith ‘537; Larry C. et al. (US 11969537 B2).
Regarding pending claim 1, Smith ‘537 claims all limitations in patented claim 1, namely a fluid waste container assembly (claim 1, a fluid waste container assembly,);
comprising: a first container (claim 1, a container);
a base forming a bottom for the first container, the base having an interior surface at least partially defining a drain opening (claim 4, a base forming a bottom for the container, the base having an interior surface at least partially defining a drain opening;);
a lid assembly providing selective access to an interior of the first container (claim, 4, a lid assembly providing selective access to an interior of the container);
a vacuum pump for producing suction in the first container (claim 2, a vacuum pump for producing suction in the container);
a primary vacuum level detection system for setting a vacuum level in the first container by controlling output of the vacuum pump (claim 1, a suction regulator for regulating operation of the vacuum pump); and
a secondary vacuum level detection system for monitoring vacuum level in the first container (claim 1, a vacuum level detection system for sensing a vacuum level generated by the vacuum pump).
Regarding pending claim 2, Smith ‘537 claims all limitations in patented claim 2.
Regarding pending claim 11, Smith ‘537 does not explicitly claim a second container, additional primary vacuum level detection system or an additional secondary vacuum level detection system.
These limitations are interpreted as a duplication of parts, which does not provide patentability unless a new and unexpected result is produced. One would have been motivated to duplicate Smith ‘537’s container and primary / secondary detection systems in order to expand the assembly’s general capacity or to provide a backup system. See MPEP 2144.04 (VI)(B).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Silverstein; Steven et al. US 4978004 A
Meyer; Johannes et al. US 20080281281 A1
Fraser; Anthony Henry Joseph et al. US 20100187233 A1
Thorpe; Timothy et al. US 20110266297 A1
Acedo; Carlos US 20120261378 A1
Zabaleta; Daniel A. et al. US 20140042164 A1
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/Adam Marcetich/
Primary Examiner, Art Unit 3781