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 .
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.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-4 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 1, the recitation “the safety period when the electronic pump motor controller has reduced functionality is shorter than a duration of the safety period when the user interface controller has reduced functionality” does not appear to have sufficient support in the original disclosure. The term “safety period” only appears in paragraphs [0032-33] of the originally filed Specification. Although there is discussion of different durations for the safety period, none of these is as specific as the recitation in the claim. Paragraph [0033] does state the safety period can be different between different controllers, however safety periods are recited as existing between two controllers rather than each controller being characterized by its own safety period. For example, the safety period between the UIC and PMC may be shorter than the safety period between the UIC and CE. In light of this disclosure, the sentence “a shorter safety period for separate, isolated, and/or independent operation between the UIC and PMC may be needed to avoid operation of the pump driver 14 without the benefit of input from a user, without the benefit of one or more reports or alarms to the user from the UIC while the pump driver 14 continues pumping, and/or without the benefit of tracking of pumping by the UIC” still appears to refer to the safety period between the UIC and PMC being shorter than the safety periods between other pairs of controllers.
Similar discussion applies to claim 3 reciting a particular difference of no more than 5 minutes safety period for the UIC and no more than one minute safety period for the PMC. Although [0032] lists some exemplary safety period durations including at least about 30 seconds and at least about 1 minute and no more than about 5 minutes. This, is not sufficient to support each of the UIC and PMC having different safety periods when they are communicating with each other. Additionally, there is lack of support for the entire range of “no more than one minute” because the Specification lists “at least about 30 seconds” and “at least about one minute” and the claim scope is covering periods less than 30 seconds and less than one minute.
Dependent claims 2-4 are also rejected for depending on at least one rejected claim above.
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 13-14 and 26 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.
Regarding claims 13-14, the terms “generally” flat, linear and curved are unclear because they are relative terms of degree and the standard for measuring the degree is unclear from the Specification. That is, because the flatness, linearity, and curvedness are not described with sufficient objective function (no standard for linearity; flatness and curvedness associated with relative hand positioning), the Specification does not provide sufficient information to determine the standard for measuring what is generally flat versus what is generally curved versus what is generally linear. MPEP2173.05(b)(I-II, IV).
Regarding claim 26, the recitation of determining impact severity with no practical application of this determination, appears to be an abstract idea (such as a mental process or mathematical operation) that would be rejected under 101. If Applicant intends such determination to be a data point recorded for future reference, this should be recited in the claim.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 5 and 7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fathallah 7258534 (Fathallah534).
Regarding claim 5, Fathallah534 teaches a medical infusion pump system (Fig 1) comprising:
a pump housing (16) comprising a cavity (in 16 in Fig 2) accessible on a leftmost side or rightmost side thereof (as shown in Fig 2);
a cover (including rest of 12 in Fig 1) configured to at least partially cover the cavity of the pump housing (closes the cavity in Fig 2 when assembled per Fig 1)
a user display (282);
a modular electromechanical pump driver (20) positioned within the cavity of the pump housing (Fig 2),
the modular electromechanical pump driver comprising a motor (142), a loader (74) configured to receive a disposable fluid holder (50), and a plunger (136) configured to pump medical fluid through the disposable fluid holder (Fig 21; col.1 ll.28-31);
wherein the motor, loader, and plunger of the modular electromechanical pump driver are directly or indirectly connected to each other as a removable unit (Fig 2), and
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the cover is configured to be positioned over a side surface (Fig 2 above) of the modular electromechanical pump driver when the modular electromechanical pump driver is positioned within the cavity of the pump housing (Figs 1-2); and
the removable unit can be removed from within the pump housing by removing the cover and without removing the motor, the loader, or the plunger from each other and without removing a portion of the pump housing that generally surrounds and extends past a back surface of the modular electromechanical pump driver (removing the unit comprising detaching the cover 12 from the housing 16, and then removing the unit from the housing; Figs 1-2).
Note, however Fathallah decides to name its components does not change how the physical structure of the components may read upon the broadest reasonable interpretation of the claim. Although Fathallah calls 16 a cover and 12 a housing, it is just as reasonable to call 16 the housing, and 12 the cover.
Regarding claim 7, Fathallah534 teaches all the limitations of the claimed invention as discussed above. Fathallah534 further teaches a user interface controller (UIC) (controller 280 controls user interface device 282 and is considered a UIC).
Claim(s) 20-24 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hasegawa 9808316.
Regarding claim 20, Hasegawa teaches a medical infusion pump system (Figs 1-5, including infusion pump 1) comprising:
a pump housing (incl. rack 500 of Figs 2-3) having a rear surface (a surface of one of the clamps 400 in Fig 5; see further discussion below);
a display (3 in Fig 8A) ;
a processor (at least to control the display);
at least one electromechanical pump driver at least partially contained within the pump housing (Figs 8A-B; infusion pump is electromechanical per col.9 l.37 - col.10 l.6);
a power source on or within the pump housing (Figs 1-4A and Fig 15A depicting outlets/sockets); and
a connector (other of the clamps 400) configured to separately receive and secure the medical infusion pump system to one pole (499) of a plurality of different-sized IV pole stands (Fig 1; 400 is capable of connecting to several different sized IV pole stands),
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the connector comprising a first surface that is perpendicular to a second surface (Fig 6 above),
the second surface is substantially coplanar with the rear surface of the pump housing (Fig 6 above),
each of the first surface and the second surface being configured to simultaneously contact the one pole of the plurality of different-sized IV pole stands when the connector receives and secures each one of the plurality of different-sized IV pole stands (Figs 1, 6),
wherein the rear surface is configured to contact and secure the connector to at least one of the plurality of different-sized IV pole stands (Figs 1, 6).
Regarding claim 21, Hasegawa teaches all the limitations of claim 20 as discussed above. Hasegawa further teaches a combination of the pump system of claim 20 and one or more of the pole stands (Fig 1).
Regarding claim 22, Hasegawa teaches all the limitations of the claimed invention as discussed above. Hasegawa further teaches the connector comprises an actuator (704,704N).
Regarding claim 23, Hasegawa teaches all the limitations of the claimed invention as discussed above. Hasegawa further teaches the actuator comprises a knob (704) and a threaded shaft (704N).
Regarding claim 24, Hasegawa teaches all the limitations of the claimed invention as discussed above. Hasegawa further teaches the connector is configured to secure the medical infusion pump system to the one pole of the plurality of different-sized IV pole stands without tilting (clamps 400 facilitate securement without tilting by limiting rotation about an axis perpendicular to the ground; Figs 1-6).
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, 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 1-4 and 38-39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fathallah534 in view of Belkin 9662436.
Regarding Claim 1, Fathallah534 7258534 teaches a medical infusion pump system (Title, col.3 ll.20-27) comprising:
a pump housing (12, 16);
an electromechanical pump driver (incl.136,142) positioned within the pump housing (Figs 1, 21), the electromechanical pump driver configured to receive a disposable fluid holder (50) and to pump medical fluid through the disposable fluid holder (vis 52, 54);
an electronic pump motor controller (280, 284, 286) positioned within the pump housing (Figs 1, 21),
the electronic pump motor controller being in electrical communication with the electromechanical pump driver (Fig 21);
a user interface (282); and
a communicator (indicator window 18).
Fathallah534 does not teach one or more additional electronic controllers within the pump housing, the one or more additional electronic controllers comprising a user interface controller in electrical communication with a user interface; wherein the electronic pump motor controller and the user interface controller are each configured to be capable of continuing operation during a safety period when the other of the electronic pump motor controller and the user interface controller have reduced functionality; wherein a duration of the safety period when the electronic pump motor controller has reduced functionality is shorter than a duration of the safety period when the user interface controller has reduced functionality.
However, Belkin 9662436 teaches a medical infusion pump system (Title) comprising:
a pump motor to deliver a fluid (col.3 ll.1-2);
an electronic pump motor controller (101),
the electronic pump motor controller being in electrical communication with the pump motor (col.3 ll.1-2); and
an additional electronic controller (102) comprising a user interface controller (102 is a UIC) in electrical communication with a user interface (202);
wherein the electronic pump motor controller and the user interface controller are each configured to be capable of continuing operation during a safety period when the other of the electronic pump motor controller and the user interface controller have reduced functionality (col.3 l.39 - col.4 l.3);
wherein a duration of the safety period when the electronic pump motor controller has reduced functionality is shorter than a duration of the safety period when the user interface controller has reduced functionality (when the pump motor controller has reduced functionality by not communicating a heartbeat, the safety period of continued normal operation of both UI and pump motor lasts only until the time period for the missing heartbeat passes; when the UIC has reduced functionality by not communicating a heartbeat, the safety period of continued normal operation of the pump motor extends beyond the time period for the missing heartbeat because the pump motor controller can continue pump motor operations normally and provide minimal required UI until the UIC reboots, performs diagnostics tests, and becomes operational, or until the infusion program is complete; Figs 4-5, Abstract, col.9 l.43 - col.10 l.45).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the infusion pump of Fathallah534 to use the multiple controller and heartbeat arrangement as taught by Belkin, in order to provide failsafe operation as taught by Belkin (Belkin, Abstract).
Regarding claim 2, Fathallah534 in view of Belkin teaches all the limitations of the claimed invention as discussed above, Fathallah534 in view of Belkin as discussed so far, does not teach the electronic pump motor controller and the user interface controller are located on separate printed circuit boards in different places within the pump housing.
However, Belkin teaches the electronic pump motor controller and the user interface controller being wholly functionally separate controllers where one can reboot without the other. Figure 2 of Belkin is also described as the hardware architectural diagram and shows the UIC 102 as a separate hardware component from the PMC 101.
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to implement the controllers of Fathallah534 in view of Belkin on separate printed circuit boards (which, by definition, require different spaces for locating within the pump housing) as taught by Belkin, in order to provide failsafe operation as taught by Belkin (Belkin, Abstract). Even if it is not wholly clear from Belkin alone, that the PMC and UIC are on pieces of circuit board that are separate or separable, MPEP 2144.04 (V)(C) provides that making joined items separable was an obvious extension of prior art teachings so long as the prior art did not teach away from separation. In this case, everything in Belkin points towards separable hardware and nothing in Belkin teaches away from separate printed circuit boards. Furthermore, one of ordinary skill in the art would have recognized that separate printed circuit boards for the separate controllers provides further failsafe/redundancy for the apparatus (e.g. by mitigating the spread of a physical fault in the hardware of one controller spreading to the other controller) as desired by Belkin, and also increases ease of maintenance by making each controller individually replaceable.
Regarding claim 3, Fathallah534 in view of Belkin teaches all the limitations of the claimed invention as discussed above, Fathallah534 in view of Belkin as discussed so far, does not teach duration of the safety period of the user interface controller is no more than 5 minutes and the duration of the safety period of the electronic pump motor controller is no more than one minute.
However, Belkin further teaches the safety period of the electronic pump motor controller is only the duration between heartbeats (which is on the order of seconds, which is less than one minute) and the safety period for the UIC depending on the remaining infusion pump program, which may be less than 5 minutes. Note, these limitations are functional limitations, and because the claim is an apparatus claim defined by what the device is and not by what the device does, the intended use or desired result of using the device only limits the invention by what structure is required to achieve the use or result. In this case, the arrangement of the controllers in Belkin is capable of a safety period of less than a minute for the electronic pump motor controller and less than 5 minutes for the UIC.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the infusion pump of Fathallah534 in view of Belkin to use the multiple controller and heartbeat arrangement as taught by Belkin, in order to provide failsafe operation as taught by Belkin (Belkin, Abstract).
Regarding claim 4, Fathallah534 in view of Belkin teaches all the limitations of the claimed invention as discussed above, Fathallah534 in view of Belkin also teaches each of the electronic pump motor controller and the user interface controller are configured to communicate data or instructions with each other.
That is, as discussed above, Belkin further teaches each of the electronic pump motor controller and the user interface controller are configured to communicate data or instructions with each other (col.3. 39 - col.4 l.3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the infusion pump of Fathallah534 in view of Belkin to use the multiple controller and heartbeat arrangement as taught by Belkin, in order to provide failsafe operation as taught by Belkin (Belkin, Abstract).
Regarding claim 38, Fathallah534 in view of Belkin teaches all the limitations of the claimed invention as discussed above. Fathallah534 in view of Belkin as discussed so far, does not teach the safety period begins when a confirmatory signal is not received by the electronic pump motor controller or the user interface controller.
However, Belkin further teaches at least the safety period of the user interface controller begins when a confirmatory signal (heartbeat) is not received by the electronic pump motor controller.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the infusion pump of Fathallah534 in view of Belkin to use the multiple controller and heartbeat arrangement as taught by Belkin, in order to provide failsafe operation as taught by Belkin (Belkin, Abstract).
Regarding claim 39, Fathallah534 in view of Belkin teaches all the limitations of the claimed invention as discussed above. Fathallah534 in view of Belkin as discussed so far, does not teach the one or more additional electronic controllers comprises a communications engine in electrical communication with a communicator.
However, Belkin further teaches another additional controller (101N) comprising a separate communications engine (101N controls communications to additional speakers 205a, either remote or local, col.3 ll.51-53; col.7 l.66 – col.8 l.5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the infusion pump of Fathallah534 in view of Belkin to use multiple controllers as taught by Belkin, in order to provide failsafe operation as taught by Belkin (Belkin, Abstract).
Claim 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fathallah534 in view of Fathallah616.
Regarding claim 6, Fathallah534 teaches all the limitations of the claimed invention as discussed above. Fathallah534 does not teach a second modular electromechanical pump driver.
However, Fathallah616 teaches the substitutional equivalence of using only using a single one of the pump driver and using two of the pump driver (Figs 1, 1A).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the pump system of Fathallah534 to have two pump drivers as taught by Fathallah616 because Fathallah616 teaches the substitutional equivalence of using one versus two pump drivers (Fathallah616, Figs 1, 1A; MPEP2144.06(II)) and because MPEP2144.04(VI)(B) provides that mere duplication of essential working parts of a device for amplified effect is an obvious extension of prior art teachings, In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960), MPEP 2144.04 VI B, the amplified effect being the number of fluids that can be delivered.
Claim 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fathallah534 in view of Fathallah616 and Duffy 5941846.
Regarding claim 8, Fathallah534 teaches all the limitations of the claimed invention as discussed above. Fathallah534 does not teach the UIC processor or the CE processor are capable of functioning when the modular electromechanical pump driver is separated from the pump housing.
However, Fathallah616 teaches the substitutional equivalence of using only a single one of the pump driver and using two of the pump drivers in a single pump system (Figs 1, 1A).
And, Duffy teaches it was known to arrange infusion pump systems with a distributed power and control arrangement (col.1 ll.22-29) such that the UIC processor (of a central interface unit 102) is capable of functioning when one or more of the modular pump drivers (104) is separated from the system to facilitate modularity and increased flexibility and functionality with central control (Fig 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the pump system of Fathallah534 to have two pump drivers as taught by Fathallah616 because Fathallah616 teaches the substitutional equivalence of using one versus two pump drivers (Fathallah616, Figs 1, 1A; MPEP2144.06(II)) and because MPEP2144.04(VI)(B) provides that mere duplication of essential working parts of a device for amplified effect is an obvious extension of prior art teachings, In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960), MPEP 2144.04 VI B, the amplified effect being the number of fluids that can be delivered.
And it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Fathallah534 in view of Fathallah616 to use a central UIC operable regardless of pump driver device connection as taught by Duffy, in order to support modularity and flexibility with central control (Duffy, Fig 1, Abstract, col.1 ll.22-29).
Claims 9 and 11-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Davis 8078983 in view of Fathallah616 and Black 3858815.
Regarding claim 9, Davis teaches a medical infusion pump system (Title, Fig 5) comprising:
a pump housing (incl. at least shaded portions of Fig 5 below) formed of a plurality of discrete panels (as defined by solid lines in Fig 5 below) with one or more boundaries between the plurality of discrete panels of the pump housing (solid line(s) between panels in Fig 5 below);
a user display (122);
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an electromechanical pump driver positioned on or within the pump housing (132, 136; col.7 ll.29-32);
a battery positioned on or within the pump housing (Fig 5 above, depicting the entire pump unit incl. charging cable, and showing battery indicator; col.15 ll.16-21, col.17 ll.6-8); and
a handle (Fig 5 above) connected to the pump housing (Fig 5), and the handle not including any portion of the one or more boundaries between the plurality of discrete panels of the pump housing (Fig 5).
It may not be clear from Fig 5 of Davis, that the handle is formed as a unitary structure. Davis also does not teach the handle having an opening extending entirely through the handle from a first end to a second end thereof; and an internal connector having an abutment surface and a projection extending distally from the abutment surface, wherein the projection extends into the opening of the handle at the first end or the second end in an assembled state of the medical infusion pump system.
However, Fathallah616 teaches the same, or substantially similar dual channel infusion pump (Fig 1A) with a unitary handle (Figs 1A, 4-5A);
the handle having an opening at a first end (hole accommodating a fastener, Fig 5A below), and an internal connector (screw fastener in Fig 5A) having an abutment surface (at least part of the head of the screw fastener) and a projection (shaft of the screw fastener) extending distally from the abutment surface (Fig 5A), wherein the projection extends into the opening of the handle at the first end in an assembled state of the medical infusion pump system (Fig 5A).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the handle of Davis as taught by Fathallah616 because Fathallah616 teaches such a handle being specifically suitable to such a dual channel infusion pump of Davis (Fathallah616, Figs 1A, 4-5A). Furthermore, it has been held that combining or simple substitution of prior art elements according to known methods to yield predictable results renders the limitation obvious (see MPEP 2141 (III)). In this case, substituting the handle of Fathallah616 for the handle of Davis having the same apparent structure would have yielded the predictable result of a functional handle for carrying the dual channel pump.
Davis in view of Fathallah616 does not teach the handle being hollow such that the opening extends from the first end to the second end.
However, Black teaches it was known to make handles hollow in order to reduce weight (cl.7).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the handle of Davis in view of Fathallah16 hollow as taught by Black in order to reduce weight (Black, cl.7).
Regarding claim 11, Davis in view of Fathallah616 and Black teaches all the limitations of the claimed invention as discussed above. Davis in view of Fathallah616 and Black as discussed so far, does not teach the internal connector helps to reinforce the handle against breakage when the medical infusion pump system is held by a user.
However, Fathallah616 further teaches the internal connector helps to reinforce the handle against breakage when the pump is held by a user because the internal connector is one of two fasteners, such that it reinforces the handle against breakage when compared to only using a single fastener (Figs4-5A).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the handle of Davis in view of Fathallah616 and Black as taught by Fathallah616 because Fathallah616 teaches such a handle being specifically suitable to such a dual channel infusion pump of Davis (Fathallah616, Figs 1A, 4-5A). Furthermore, it has been held that combining or simple substitution of prior art elements according to known methods to yield predictable results renders the limitation obvious (see MPEP 2141 (III)). In this case, substituting the handle of Fathallah616 for the handle of Davis having the same apparent structure would have yielded the predictable result of a functional handle for carrying the dual channel pump.
Regarding claim 12, Davis in view of Fathallah616 and Black teaches all the limitations of the claimed invention as discussed above. Davis in view of Fathallah616 and Black as discussed so far, does not teach an upper surface of the handle is continuous with an upper surface of the pump housing.
However, Fathallah616 further teaches an upper surface of the handle is continuous with an upper surface of the pump housing (Fig 2 below).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the handle of Davis in view of Fathallah616 and Black as taught by Fathallah616 because Fathallah616 teaches such a handle being specifically suitable to such a dual channel infusion pump of Davis (Fathallah616, Figs 1A, 4-5A). Furthermore, it has been held that combining or simple substitution of prior art elements according to known methods to yield predictable results renders the limitation obvious (see MPEP 2141 (III)). In this case, substituting the handle of Fathallah616 for the handle of Davis having the same apparent structure would have yielded the predictable result of a functional handle for carrying the dual channel pump.
Regarding claim 13, Davis in view of Fathallah616 and Black teaches all the limitations of the claimed invention as discussed above. Davis in view of Fathallah616 and Black as discussed so far, does not teach the upper surface of the handle and the upper surface of the pump housing are generally linear.
However, Fathallah616 further teaches the upper surface of the handle and the upper surface of the pump housing are generally linear (Fig 2 below).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the handle of Davis in view of Fathallah616 and Black as taught by Fathallah616 because Fathallah616 teaches such a handle being specifically suitable to such a dual channel infusion pump of Davis (Fathallah616, Figs 1A, 4-5A). Furthermore, it has been held that combining or simple substitution of prior art elements according to known methods to yield predictable results renders the limitation obvious (see MPEP 2141 (III)). In this case, substituting the handle of Fathallah616 for the handle of Davis having the same apparent structure would have yielded the predictable result of a functional handle for carrying the dual channel pump.
Regarding claim 14, Davis in view of Fathallah616 and Black teaches all the limitations of the claimed invention as discussed above. Davis in view of Fathallah616 and Black as discussed so far, does not teach an upper surface of the handle is generally flat and a lower surface of the handle is generally curved.
However, Fathallah616 further teaches an upper surface of the handle is generally flat and a lower surface of the handle is generally curved (Fig 2 below showing at least two different interpretations of the corresponding surfaces).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the handle of Davis in view of Fathallah616 and Black as taught by Fathallah616 because Fathallah616 teaches such a handle being specifically suitable to such a dual channel infusion pump of Davis (Fathallah616, Figs 1A, 4-5A). Furthermore, it has been held that combining or simple substitution of prior art elements according to known methods to yield predictable results renders the limitation obvious (see MPEP 2141 (III)). In this case, substituting the handle of Fathallah616 for the handle of Davis having the same apparent structure would have yielded the predictable result of a functional handle for carrying the dual channel pump.
Regarding claim 15, Davis in view of Fathallah616 and Black teaches all the limitations of the claimed invention as discussed above. Davis further teaches the housing comprises a finger recess located near the handle to accommodate holding of the handle (Fig 5)
The finger recess of Davis in view of Fathallah616 and Black may not be clearly visible from Davis alone.
However, Fathallah616 further teaches the housing comprises a same finger recess (housing contoured to provide a space/recess in the shaded region for fingers to hold the handle; Fig 2) located near the handle (Fig 2).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Davis in view of Fathallah616 and Black as taught by Fathallah616 because Fathallah616 teaches such a handle and housing arrangement being specifically suitable to such a dual channel infusion pump of Davis (Fathallah616, Figs 1A, 4-5A). Furthermore, it has been held that combining or simple substitution of prior art elements according to known methods to yield predictable results renders the limitation obvious (see MPEP 2141 (III)). In this case, substituting the handle of Fathallah616 for the handle of Davis having the same apparent structure would have yielded the predictable result of a functional handle for carrying the dual channel pump.
Regarding claim 16, Davis in view of Fathallah616 and Black teaches all the limitations of the claimed invention as discussed above. Davis in view of Fathallah616 and Black as discussed so far, does not teach one or more seals located between the handle and the pump housing.
However, Fathallah616 further teaches one or more seals located between the handle and the pump housing (Fig 5A below).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Davis in view of Fathallah616 and Black as taught by Fathallah616 because Fathallah616 teaches such a handle and housing arrangement being specifically suitable to such a dual channel infusion pump of Davis (Fathallah616, Figs 1A, 4-5A). Furthermore, it has been held that combining or simple substitution of prior art elements according to known methods to yield predictable results renders the limitation obvious (see MPEP 2141 (III)). In this case, substituting the handle of Fathallah616 for the handle of Davis having the same apparent structure would have yielded the predictable result of a functional handle for carrying the dual channel pump.
Claims 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Johnson 5378231 in view of Duffy and Fathallah534.
Regarding claim 17, Johnson teaches a medical infusion pump system (Fig 1) comprising:
a pump housing (incl. 50, 54);
a plurality of electromechanical pump drivers at least partially contained within the pump housing (4, 6, 8);
the plurality of electromechanical pump drivers including a motor (col.13 ll.10-43), a loader (to receive cassettes 13 in Fig 2), and a plunger (col.13 ll.10-43) secured together (for operation);
a battery (42); and
one or more electronic processors (required in 16 in 2) within the pump housing (Figs 1-2) in electrical communication with the plurality of pump drivers (Figs 1-2); and
a memory (required in 16 in 2) within the pump housing (Figs 1-2) that is associated with the one or more electronic processors (therewithin), the memory configured to contain information about one or more pumping parameters executed by or to be programmed for execution by at least two of the pump drivers (col.3 ll.13-30).
It is not clear if the battery of Johnson is on or within the pump housing. Johnson also does not teach whether the motor, loader, and plunger of each pump driver are assembled as a single removable unit configured to be removable from the pump housing.
However, Duffy teaches providing a battery positioned on or within the pump housing (of 102) of an infusion pump system (Fig 1) to enable flexible powering options including both external AC or DC “as was known in the art” (col.10 ll.8-18).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Johnson to include an internal battery as taught by Duffy, in order to provide flexible powering options including both external AC or DC “as was known in the art” (col.10 ll.8-18).
Johnson in view of Duffy still does not teach whether the motor, loader, and plunger of each pump driver are assembled as a single removable unit configured to be removable from the pump housing.
However, Fathallah534 teaches provision of the electromechanical pump driver(s) of an infusion pump as a modular unit (20) where a motor (142), loader (74), and plunger (136) are assembled as a single removable unit configured to be removable from the pump housing (Figs 1-2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the pump drivers of Johnson in view of Duffy to be modular replaceable units as taught by Fathallah534 for ease of maintenance/replacement (col.3 ll.28-36).
Regarding claim 18, Johnson in view of Duffy and Fathallah534 teaches all the limitations of the claimed invention as discussed above. Johnson further teaches the one or more electronic processors is configured to warn a user of the medical infusion pump system if incompatible medical fluids are programmed to be infused through two different modular electromechanical pump drivers of the plurality of modular electromechanical pump drivers (col.7 ll.21-51).
Regarding claim 19, Johnson in view of Duffy and Fathallah534 teaches all the limitations of the claimed invention as discussed above. Johnson further teaches the one or more electronic processors are configured to prevent infusion of incompatible medical fluids through two different modular electromechanical pump drivers of the plurality of modular electromechanical pump drivers (col.7 ll.21-41; prevents simultaneous infusion of incompatible fluids by first notifying and prompting user, and then if user so chooses, flushing between infusions).
Claim(s) 31 and 37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lim WO2022140204A1 in view of Zhou- (Zhou et al. Performance-aware thermal management via task scheduling, 07 May 2010, ACM Transactions on Architecture and Code Optimization (TACO), Volume 7, Issue 1, Article No.5, pp.1-31).
Regarding claim 31, Lim teaches a medical infusion pump system (AMD 600) comprising:
a pump housing (Fig 5B; [0118]);
a display (608, Fig 5B; [0118, 122]);
at least one processor (610);
at least one electromechanical pump driver (606; [0121]) at least partially contained within the pump housing ([0118]);
a power source on or within the pump housing (all the modules of the fully portable AMD in Figs 5B-6 being contained in/on the housing and requiring a power source; Fig 1A compatible with Figs 5A-6; [0604]); and
one or more temperature sensors in electronic communication with the at least one processor ([0353] setting alarm in response to high temperature battery requires temperature sensor in communication with processer);
wherein the at least one processor is configured to determine when the one or more temperature sensors detect an increase in temperature above an acceptable operating temperature and, in response to detecting the increase in temperature above the acceptable operating temperature, automatically modify one or more operations of the medical infusion pump system (alarm triggered when battery temp is high; [0353]).
Lim does not teach modifying one or more operation of the medical infusion pump based on a hierarchy of functionality.
However, Zhou teaches automatically modifying one or more operations of an electronic device (with computer chip) when an overheating condition is detected based on a hierarchy of functionality (Abstract; by performing “hot” and “cool” jobs in a different order).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the computer-based device of Lim, to hierarchically modify operation when overheating is detected as taught by Zhou, in order to minimize performance degradation while managing temperature (Abstract).
Regarding claim 37, Lim in view of Zhou teaches all the limitations of the claimed invention as discussed above. Lim in view of Zhou also teaches the hierarchy of functionality is configured to modify the highest power consuming operation of the one or more operations first.
That is, Zhou teaches performing “hot” (higher power consuming) and “cool” (lower power consuming) jobs in particular sequence to manage/mitigate overheating. Zhou’s particular method is to (generally) perform job sin hot-cold order, but Zhou also describes other prior art methods that adjusts priority ranks of hot and cool jobs (p.3). In both cases the highest power consuming operation of the one or more operations is modified (adjusted in rank or order of operation) to be first (p.3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the computer-based device of Lim in view of Zhou, to hierarchically modify operation when overheating is detected as taught by Zhou, in order to minimize performance degradation while managing temperature (Abstract).
Claims 32 and 36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lim in view of Zhou, and further in view of Sony Bloggie (Sony, Bloggie Handbook Mobile HD Snap Camera MHS-FS1/FS1k/FS2/FS2k, 2011, Sony Corporation 4-275-040-12(1)).
Regarding claim 32, Lim in view of Zhou teaches all the limitations of the claimed invention as discussed above. Lim further teaches performing updates when there is not a therapy in progress (Fig 9).
Lim in view of Zhou does not teach the at least one processor is configured to halt an updating process when the one or more temperature sensor has detected an increase in temperature above the acceptable operating temperature.
However, Sony Bloggie teaches it was known to shut off an electronic device (i.e. camera) when a temperature sensor has detected an increase in temperature above the acceptable operating temperature (p.3GB). Sony Bloggie is considered analogous art because it is addressing one of the same problems as Applicant, which is handling overheating conditions in electronic devices.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Lim in view of Zhou to automatically shut off (and thus end non-therapy processes such as updates) when a temperature detects overheating as taught by Sony Bloggie, in order to protect the device from overheating (Sony, p.3GB).
Regarding claim 36, Lim in view of Zhou and Sony Bloggie teaches all the limitations of the claimed invention as discussed above. Lim in view of Zhou and Sony Bloggie as discussed so far, does not teach the at least one processor is configured to delay or slow down one or more operations of the medical infusion pump system unless or until the temperature returns to the acceptable operating temperature.
However, Sony Bloggie teaches it was known to shut off an electronic device (i.e. camera) when a temperature sensor has detected an increase in temperature above the acceptable operating temperature (p.3GB). This shutting down delays the intended use of the device until it stops occurring (i.e. until temperature returns to acceptable operating temperature).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Lim in view of Zhou and Sony Bloggie to automatically shut off (and thus end non-therapy processes such as updates) when a temperature detects overheating as taught by Sony Bloggie, in order to protect the device from overheating (Sony, p.3GB).
Claim 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lim in view of Zhou, and further in view of Panasonic (Panasonic, Reference Manual Personal Computer Model No. CF-31 Series, 2010, Panasonic Corporation, PCE0301A_XP/7).
Regarding claim 33, Lim in view of Zhou teaches all the limitations of the claimed invention as discussed above. Lim further teaches the display being capable of adjusting brightness ([0407, 548]).
Lim in view of Zhou does not teach the at least one processor is configured to dim the display when the one or more temperature sensors have detected an increase in temperature above the acceptable operating temperature.
However, Panasonic teaches dimming the display of an electronic device (i.e. laptop) when the temperature sensor has detected an increase in temperature above the acceptable operating temperature (p.113, first row of second table). Panasonic is considered analogous art because it is addressing one of the same problems as Applicant, which is handling overheating conditions in electronic devices.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the dimmable display of Lim in view of Zhou to dim the display at high operating temperatures as taught by Panasonic, to avoid malfunction (p.113, first row of second table).
Claim 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lim in view of Zhou, and further in view of Sony Camcorder1.
1 Sony, Sony Camera and Camcorder Battery Information, 2010, sony.com via Wayback Machine, Article ID: S1Q0399, https://web.archive.org/web/20210126195509/https://www.sony.com/electronics/support/dvd-camcorders-dcr-dvd-series/dcr-dvd101/articles/S1Q0399)
Regarding claim 34, Lim in view of Zhou teaches all the limitations of the claimed invention as discussed above. Lim further teaches the power source is a battery ([0353]), and triggering an alarm when the temperature of the battery is too high ([0353]).
Lim does not teach the at least one processor is configured to halt charging the battery when the one or more temperature sensors have detected an increase in temperature above the acceptable operating temperature.
However, Sony Camcorders teaches halting charging a battery when the temperature sensor has detected an increase in temperature above the acceptable operating temperature (p.2, fourth bullet) because the battery pack does not charge effectively outside of the proper operating temperature (p.1, fifth to last bullet). Sony Camcorder is considered analogous art because it is addressing one of the same problems as Applicant, which is handling overheating conditions in electronic devices.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Lim in view of Zhou to stop charging at high temperatures as taught by Sony Camcorders, because charging may not be effective outside of certain operating temperatures (p.1, fifth to last bullet).
Claim 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lim in view of Zhou, and further in view of Amirouche 20180214636.
Regarding claim 35, Lim in view of Zhou teaches all the limitations of the claimed invention as discussed above. Lim iv.. Zhou does not teach the at least one processor is configured to delay or slow down the one or more operations of the medical infusion pump system in response to an increase in temperature above the acceptable operating temperature.
However, Amirouche teaches restricting access to a drug loaded into the infusion pump when a temperature of the drug is detected as exceeding the safe threshold temperature of the drug ([0087]), this delays drug delivery for the safety of the patient ([0010]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Lim in view of Zhou to include the drug temperature safety control of Amirouche in order to ensure safe drug delivery to patient, e.g. without gas bubbles arising from temperature variation ([0010, 87]).
Allowable Subject Matter
Claims 25 and 28-30 appear to be allowable.
Response to Arguments
Applicant's arguments filed 16 January 2026 have been fully considered but they are not persuasive. Applicant generally relies on the interview discussion to assert patentability.
Applicant’s arguments with respect to claim(s) 9, 11-24, and 31-37 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.
Regarding claim 1, despite the conclusion reached during the preparation for the interview (note, limited time of only 30minutes or less is provided to examiners for reviewing interview agendas in preparation for the interview) held on 06 January 2026, it was unfortunately found - upon further search and consideration - that the previously applied prior art was sufficient to teach the claim under a different interpretation. See also, 112a rejection above.
Regarding claim 5, no particular language was agreed upon during the interview. The amendments were not sufficient to overcome the previously applied prior art.
Claims 25-26 and 28-30 are not rejected over prior art.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEPHANIE SEBASCO CHENG whose telephone number is (469)295-9153. The examiner can normally be reached on 1000-1600 ET.
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/STEPHANIE SEBASCO CHENG/Primary Examiner, Art Unit 3741