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 .
Election/Restrictions
Applicant's election with traverse of Group I, Claims 1-21, in the reply filed on 12/8/25 is acknowledged. The traversal is on the ground(s) that the common technical features are “special technical features”. This is not found persuasive because “The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art” [See MPEP 1850, PCT Rule 13.2]. It is first noted here that Applicant has amended the claims. As was previously shown for the previous claims, and as is currently shown in detail in the subject matter rejection section below for the amended claims, the common technical features are met by the prior art, thus by definition they are not “special technical features”, as they do not define a contribution which each of the invention makes over the prior art. See Rules 475 and 499, which fully adopt PCT Rule 13 and Unity of invention practice during the national stage. Also see MPEP 823, 1850, 1875 and 1893.03(d). Applicant is reminded that Unity of invention is a requirement and it differs from restriction practice in non-371 applications [111(a), bypass, and so on]. Unity of invention is required in national stage applications, and is required throughout prosecution under Rule 145.
The requirement is still deemed proper and is therefore made FINAL.
Applicant has withdrawn Claim 22.
Drawings
The drawings are objected to because Figures 1 through 11 are not sufficiently legible and clear for printing. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 1-21 are objected to because of the following informalities: 1) in Claim 1, “the cardiac contractility” should be “cardiac contractility”, 2) in Claim 1, the “electrically driven ‘mechanical pump’ “ should be “electrically driven mechanical pump”, 3) In Claim 4, “to axial, centrifugal flow, or pneumatically driven design” should be “to an axial, a centrifugal flow, or a pneumatically driven design”, 4) in Claim 7, “synthetic” should be “a synthetic”, 5) In Claim 8, “(CPU)” should be omitted, as the acronym is not used elsewhere in dependence to Claim 8 and it wasn’t presented in Claim 1, 6) in Claim 18, “(‘anastomosed’)” should be omitted, 7) in Claim 19, “the said CPU” should be corrected, 8) in Claim 20, “vital” should be omitted, as pump speed is not “vital”, and 9) in Claim 21, “Coronary” should be “coronary”. Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 5, 10, 13-15, 18 and 19 are rejected under 35 U.S.C. 101 because Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 5, 10, 13-15, 18 and 19 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
-Regarding Claim 5, the limitation “connected to the implanted battery power source” (emphasis added) does not preclude that it positively recites and requires that the device is actually implanted, and thus requires a human organism.
-Regarding Claim 10, the limitations “receiver coils are placed subcutaneously” (emphasis added) does not preclude that that it positively recites and requires that the device is actually implanted, and thus requires a human organism.
-Regarding Claim 13, the limitations “channel …is buried beneath the skin” (emphasis added) does not preclude that that it positively recites and requires that the device is actually implanted, and thus requires a human organism.
-Regarding Claim 18, the limitations “tubular body is connected with the lumen of a vessel or chamber containing …blood such as aorta or …veins” and “is connected…’anastomosed’ with…artery” (emphasis added) does not preclude that that it positively recites and requires that the device is actually implanted, and thus requires a human organism.
-Regarding Claim 19, the limitations “the implanted ECG lead” (emphasis added) does not preclude that that it positively recites and requires that the device is actually implanted, and thus requires a human organism.
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 1-21 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.
1) In Claim 1, Applicant has amended the claim to recite that the Doppler sensor is “disposed thereon” with an unclear reference to one of the distal end, the proximal end, the conduit and the tubular body (see 112b, below). Regardless of the issue of clarity, “thereon” includes the interpretation that the Doppler sensor is “on” the relevant structure, ie. on an external part of the distal end, proximal end, conduit or the tubular body. Because “thereon” does not preclude this interpretation, and because the specification is limited to a single location of the Doppler sensor, which is shown as being in the interior of the middle section of the tubular member 10 (See Fig. 4, Doppler sensor 20), the claims fails the written description requirement. A person of ordinary skill in the art would not have reasonably concluded from the original disclosure that Applicant was in possession of a device where the Doppler sensor is positioned on an exterior of the distal end, or of the proximal end, or of the conduit or of the tubular body. The only support in the original disclosure as to the location of the Doppler sensor is in ¶37 and Fig. 4, described by Applicant as “Into the distal portion of the body (10) of the hollow tubular member, beyond the ‘mechanical pump assembly’ (14), a doppler flow sensor (30) is located”. “Into” and “thereon” are quite different, the latter primarily referring to an exterior of a structure, particularly in reference to a tubular structure. Furthermore, the claims do not preclude that the “thereon” refers to the proximal end [e.g. (11)], the distal end [e.g. (12)], something which is also nowhere to be found in the original disclosure. Thus, Claim 1 fails the written description requirement. See MPEP 2163 and 2163.05.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-21 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
1) Regarding Claim 1, it is not clear which limitation “disposed thereon” refers to. Is the sensor disposed on the distal end, the proximal end, the conduit, or the body?
2) Regarding Claim 1, it is not clear what element the “its” refers to in “the lumen extends from its proximal end to its distal end”. Does this refer to the lumen itself, the channel, or back to the proximal end and distal end of the conduit?
3) Regarding Claim 2, the term “about” is relevant and subjective. The terms are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be apprised with reasonable certainty of the scope of the invention. Is “about” 0.1%, 0.5%, 1%, 5%, 10%, 0.1 cm, 1 cm, 5 cm, some other standard?
4) Regarding Claim 4, the terms “preferably but not limited to” make the scope of the claim unclear. Are the limitations that follow limiting or not? If they are not, what is the scope of the claim? In addition, “preferably” is subjective, relevant and unclear. Is the scope of the claim entirely optional?
5) Regarding Claim 5, “the implanted power source” lacks clear antecedence. In addition, it is not clear whether the “a power cable” is the same or different than the “a power cable” of Claim 1.
6) Regarding Claim 10, “the implanted power source” lacks clear antecedence.
7) Regarding Claim 11, “the vital parameters” and “the speed” lack clear antecedence.
8) Regarding Claim 11, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
9) Regarding Claim 12, “the vital parameters” lack clear antecedence.
10) Regarding Claim 12, the terms “can be” are relevant and subjective, making the metes and bounds of the claim unclear.
11) Regarding Claim 18, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
12) Regarding Claim 18, “the mechanical pump assembly” lacks clear antecedence.
13) Regarding Claim 19, “the heart rate”, “the implanted ECG lead”, lack antecedent basis.
14) Regarding claim 20, the phrase "etc." renders the claim(s) indefinite because the claim(s) include(s) elements not actually disclosed (those encompassed by "or the like"), thereby rendering the scope of the claim(s) unascertainable. See MPEP § 2173.05(d). Furthermore, it is unclear whether and what parameters are covered by “etc.”. In addition, “the pump speed” lacks clear antecedence.
15) Regarding Claim 21, the limitation “is used” in “a transducer is used to gauge” makes the scope of the claims unclear. It is not clear whether the limitation is drawn to s structural configuration, an intended use, or an otherwise optional limitation. It is not even clear whether the transducer is positively recited as part of the device or not, and it is not clear whether the “is used” limits the structure of any of the elements in the claim. See MPEP Claim 1 recites the hypothetical phrase “when” (ie. if) which renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See: MPEP § 2111.04, 2103.
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)(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.
Claims 1, 4-5, 8, 16, 18 and 21 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US 20220161019 by Mitze.
Regarding Claim 1, Mitze discloses a device comprising:
a. a tubular member body including a vascular conduit, having a proximal end and a distal end and a Doppler sensor disposed thereon [e.g. abstract, ¶¶13,199-226, and Fig. 24-28: Doppler sensor 2204 of a mechanical circulatory support blood pump (MCS pump) having tubular member 710; Doppler sensor 2204 is “on” an interior surface of the tubular body];
b. an electrically driven 'mechanical pump' housed in the tubular member body and operatively connected to an implantable battery power source through a power cable (e.g. ¶9,83, Fig. 9A: axial impeller 712 rotary blood pump; ¶71:“An MCS controller 200 may be used, which drives and operates the MCS device 100, observes its performance and condition as well as providing error and status information”, thus the controller battery also drives the pump; ¶231 and Fig. 29: “If the monitoring device is implanted in the patient 2900, the monitoring device 2932 may include an energy storage device (for example, a long-life, rechargeable battery). The energy storage device (not shown) of the monitoring device 2932 may be charged via a power, supplying cable or a wireless power transmission system”, thus the controller, along with the battery is implantable; ¶227: wired communication);
c. a channel for a coronary infusion comprising one lumen, the lumen extends from its proximal end to its distal end (e.g. ¶85, Fig. 7: port 720; ¶78, Fig. 4-5: side port 516; Fig. 3: the ports of hub 304; Fig. 79A: ports 706, 708, 908; Any of the multiple channels of the MCS, its introducers, and their hubs read on a channel capable of coronary infusion, as: a) the device assists in circulation of blood in the heart, thus any orifice of the device would permit the inflow of a substance and all flow through the device ends up anywhere cardiac flow directs the flow, including coronary vessels, and b) the limitations regarding coronary infusion are drawn to intended use and the device is capable of being used to infuse a hypothetical coronary vessel), and
d. a central processing unit operatively connected to the implantable battery power source (¶228, Fig. 29: implantable controller 2932 includes processor 2934).
As to the intended field of use of the preamble “for improving the cardiac contractility in patients with heart failure”, this is attributed by Applicant’s specification to the infusion of medications, and nothing else in particular (¶38), and as noted above, there is nothing preventing the infusion of medications for improving cardiac contractility, and any of the multitude of channels in Mitze would permit this.
Regarding Claim 4, Mitze discloses the device as claimed in claim 1, wherein the mechanical pump is preferably but not limited to axial flow design (¶9: axial pump).
Regarding Claim 5, Mitze discloses the device as claimed in claim 1, wherein the mechanical pump is connected to the implanted battery power source through a power cable and is powered by the battery power source (¶227: wired communication).
Regarding Claim 8, Mitze discloses the device as claimed in claim 1, wherein the implantable battery power source supplies electrical energy to the mechanical pump and the central processing unit [e.g. ¶9,83, Fig. 9A: axial impeller 712 rotary blood pump; ¶71:“An MCS controller 200 may be used, which drives and operates the MCS device 100, observes its performance and condition as well as providing error and status information”, thus the controller battery also drives the pump; ¶231 and Fig. 29: “If the monitoring device is implanted in the patient 2900, the monitoring device 2932 may include an energy storage device (for example, a long-life, rechargeable battery). The energy storage device (not shown) of the monitoring device 2932 may be charged via a power, supplying cable or a wireless power transmission system”, thus the controller, along with the battery is implantable; ¶228, Fig. 29: implantable controller 2932 includes processor 2934).
Regarding Claim 16, Mitze discloses the device as claimed in claim 1, wherein the central processing unit is an electronic device which controls the mechanical pump (¶¶228, 230: 2934 is a processor which is an electronic device which controls the MCS).
Regarding Claim 18, Mitze discloses the device as claimed in claim 1, wherein the proximal end of the tubular member body is capable of being connected with the lumen of a vessel or chamber containing oxygen rich blood such as aorta, subclavian artery, left atrium or one or more pulmonary veins; wherein the distal portion of the tubular member body beyond the mechanical pump assembly, is capable of being connected in a fluidly communicating manner ('anastomosed') with at least one coronary artery either directly or through distribution channels (the claims are drawn to a product, thus the positively recited connections to the body are not required; Nevertheless, the pump would be capable of being connected to any vessel given appropriate connecting means, which are not required by the claim).
Regarding Claim 21, Mitze teaches the device as claimed in claim 1, wherein a pressure transducer is capable of being used to gauge pressure in the coronary channels (the claim does not positively recite that the device include the transducer; Nevertheless, the device of Mitze includes MEMS pressure sensors, see ¶¶12-13, 15, Fig. 19,34A: pressure sensor 1100, and these pressure sensors would be capable of sensing coronary pressure if they were placed in a coronary vessel, e.g. the LMCA of a large animal).
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.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Mitze, as applied to Claim 1.
Regarding Claim 2, Mitze discloses the device as claimed in Claim 1, wherein the tubular member body is about 6-16 cm in length (¶75: the length of the MCS device is less than 8.5-16 cm; ¶82: the inlet tube 710 is 6-10 cm; ¶143: the length of portion 1310 is 1-2 cm; Thus, the length of the MCS device is between 7 and 16 cm), and is 5-15 mm wide at the proximal end (¶6: 18Fr is equal to 6mm diameter; ¶82: 5.5 mm). Mitze does not disclose that the length of the tubular member body is 15-40 cm. However, it would have been prima facie obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention, to select a length of 15-16 cm for the MCS tubular device, according to the teachings of Mitze, from the disclosed range of 7-16 cm, as according to MPEP 2144.05, in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) and a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties [MPEP 2144.05 ;Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985)], and this would predictably provide circulatory support for a patient.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Mitze, as applied to Claim 1, in view of US 2014/0296767 by Franano.
Regarding Claim 3, Mitze teaches the device as claimed in Claim 1, yet does not explicitly disclose that the vascular conduit is made of suitable biocompatible, non-thrombogenic material, which is natural or synthetic or a combination thereof, in origin.
However, Franano teaches an analogous implantable blood pump which is made of biocompatible material with non-thrombotic coatings (¶85). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to make an MCS device according to the teachings of Mitze with biocompatible and non-thrombogenic material, as taught by Franano, as: a) the selection of a known material based upon its suitability for the intended use is a design consideration within the skill of the art (In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960)), b) Franano suggests this would “reduce the accumulation of thrombus”, and c) in order to prevent a reaction by the patient’s immune system.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Mitze, as applied to Claim 1, in view of US 9878079 to Pfeffer.
Regarding Claim 6, Mitze teaches the device as claimed in claim 1, wherein the mechanical pump maintains suprasystemic blood pressure inside the inner lumen of the tubular member body (e.g. ¶69: whenever the pump is ejecting blood, the pressure inside the pump must overcome the pressure outside the pump). Mitze does not explicitly disclose ejecting blood from the tubular body during diastole. However, Pfeffer teaches an analogous blood pump which is intended for use in the same manner as Mitze’s device, and wherein the pump is capable of ejecting blood during diastole if the exterior pressure is below the pressure of the pump (e.g. 17:35-51). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to enable a pump according to the teachings of Mitze, to be capable of ejecting blood during diastole when the external pressure falls below an internal pressure of the pump, as taught by Pfeffer, is order to predictably pump some blood as suggested by Pfeffer (17:45-51), and prevent damage to the heart, and/or the pump.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Mitze, as applied to Claim 1, in view of US 20020187069 by Levin and US 9872947 by Keenan.
Regarding Claim 7, Mitze discloses the device as claimed in Claim 1, yet does not disclose wherein the channel capable for use in coronary infusion is made of synthetic polymer selected from plastic or silicone. However, Levin teaches using plastic ports in association with blood circulation pumps, as they are easy to use, inexpensive and offer suitable mechanical properties for the pressures associated with blood (¶61-62). In addition, Keenan teaches making the blood pump body from plastic (e.g. abstract). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to make any portion of the blood pump and its ports/openings from plastic in a device according to the teachings of Levin and Keenan, as: a) the selection of a known material based upon its suitability for the intended use is a design consideration within the skill of the art (In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960)), and b) Levin teaches that plastics are easy to use, inexpensive and offer suitable mechanical properties for the pressures associated with blood in the body (¶61-62).
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Mitze, as applied to Claim 1, in view of US 20180250458 by Petersen.
Regarding Claim 9, Mitze discloses the device as claimed in claim 1, wherein the battery power source is connected to a receiver (e.g. ¶231: wireless battery charging).
Mitze does not explicitly disclose that the receiver is a coil.
However, Petersen teaches an analogous blood pump which is charged transcutaneously through the use of two coils, one implanted and one transmitting energy through the skin (e.g. ¶14,17, Fig. 1C: receiver coil 202). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to incorporate transcutaneous inductive charging with a receiver coil for the wireless charging system of a device according to the teachings of Metzi, as taught by Petersen, as this would only amount a selection among known and limited wireless charging options that would have been obvious to try.
Regarding Claim 10, Mitze as modified in Claim 9 teaches the device as claimed in Claim 1, wherein the one or more receiver coils are placed subcutaneously in at least one location to enable wireless charging of the implanted battery power source, by placement of transmitter coils directly over the receiver coils across the skin (given that product claims should not claim human organisms, the claim is interpreted as intended use, which is met by the modification in Claim 9, by the added capability for transcutaneous charging taught by Petersen).
Claims 11, 17 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Mitze, as applied to Claims 1 and 16, in view of US 20200405929 by Tan.
Regarding Claim 11, Mitze discloses the device as claimed in claim 1, wherein the central processing unit monitors blood flow velocity and blood pressure through the Doppler sensor (e.g. ¶12-13, 200-205, 210-218) and controls the speed of the mechanical pump (e.g. ¶247-248; Note here that pump control is not claimed as being based on any feedback).
Mitze does not explicitly disclose that the CPU monitors the vital parameters such as heart rate, heart rhythm using at least one epicardial electrode. However, Tan teaches an analogous blood pump which includes an ECG electrode, and controls the operation of the pump based on the EKG signal, which includes a heart rate (e.g. abstract, ¶¶5,34,40,49). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to incorporate an ECG electrode and heart rate detection in a device according to the teachings of Mitze, as taught by Tan, in order to quickly identify cardiac events or changes in cardiac function, as suggested by Tan (¶9).
Regarding Claim 17, Mitze discloses the device as claimed in claim 16, yet does not disclose wherein the said CPU wherein the central processing unit incorporates a cardioverter-defibrillator which works using electrodes. However, Tan teaches an analogous blood pump which includes an ECG electrode, and controls the operation of the pump as well as provide pacing and defibrillation based on the EKG signal (e.g. abstract, ¶¶40,49). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to incorporate an ECG electrode and pacing-defibrillation in a device according to the teachings of Mitze, as taught by Tan, in order to predictably treat arrhythmia in real time and to quickly identify and respond to cardiac events or changes in cardiac function, as suggested by Tan (¶9).
Regarding Claim 19, Mitze discloses the device as claimed in claim 1, controls the speed in which the pump rotor is spinning, thereby delivering increased coronary bloodflow during exertion (¶230), yet does not disclose wherein the said CPU monitors the heart rate using the implanted ECG lead. However, Tan teaches an analogous blood pump which includes an ECG electrode, and controls the operation of the pump as well as provide defibrillation based on the EKG signal (e.g. abstract, ¶¶40,49). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to incorporate an ECG electrode and sensing in a device according to the teachings of Mitze, as taught by Tan, in order to predictably treat arrhythmia in real time and to quickly identify and respond to cardiac events or changes in cardiac function, as suggested by Tan (¶9).
Claims 12 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Mitze, as applied to Claim 1, in view of US 20220032036 by Baumbach, as evidenced by US 20070192028 by Lee.
Regarding Claim 12, Mitze discloses the device as claimed in claim 1, wherein the said CPU has in built wireless communication means, and is capable of being connected to multiple smartphones to transmit the vital parameters in real time (e.g. ¶231: controller 2932 transmits pressure signals, control signal and data to external devices).
Mitze does not explicitly disclose that the wireless communication means in Mitze is an in-built SIM card.
However, Baumbach teaches an analogous blood pump with a controller having a wireless module with integrated LoRa, NB-IoT, LTE, UMTS and/or GPRS mobile communication means (¶57). As evidenced by Lee, mobile communication means require a SIM in order to operate (¶92). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to incorporate an integrated mobile communication module (e.g. LoRa, NB-IoT, LTE, UMTS or GPRS, which require SIM card) in a device according to the teaching of Mitze, as taught by Baumbach, in order to predictably communicate data to an external device, and furthermore to do so in a more secure and personalized manner that protects the patient’s medical information.
Regarding Claim 20, Mitze discloses the device as claimed in claim 1, wherein the said CPU has in built wireless communication means, and is capable of being connected to multiple smartphones to transmit vital data including the pump speed, coronary artery pressure, heart rate, percentage of power remaining in the battery etc. (e.g. ¶231: controller 2932 transmits pressure signals, control signal and data to external devices).
Mitze does not explicitly disclose that the wireless communication means in Mitze is an in-built SIM card.
However, Baumbach teaches an analogous blood pump with a controller having a wireless module with integrated LoRa, NB-IoT, LTE, UMTS and/or GPRS mobile communication means (¶57). As evidenced by Lee, mobile communication means require a SIM in order to operate (¶92). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to incorporate an integrated mobile communication module (e.g. LoRa, NB-IoT, LTE, UMTS or GPRS, which require SIM card) in a device according to the teaching of Mitze, as taught by Baumbach, in order to predictably communicate data to an external device, and furthermore to do so in a more secure and personalized manner that protects the patient’s medical information.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Mitze, as applied to Claim 1, in view of US 7998190 by Gharib.
Regarding Claim 13, Mitze teaches the device as claimed in claim 1, wherein the proximal end of the coronary infusion channel is capable of being buried beneath the skin of the human or the animal and wherein the distal end of the coronary infusion channel opens into the inner lumen of the distal portion of the hollow tubular member body distal to the mechanical pump assembly (as noted in Claim 1, the entire pump is capable of being implanted and the pump does have openings “distal” to the pump, which would permit infusion).
Mitze does not disclose that and houses at least one coronary infusion port with an in-built one-way valve, wherein the distal end of the coronary infusion channel opens into the inner lumen of the distal portion of the hollow tubular member body distal to the mechanical pump assembly through a one-way valve. However, Gharib teaches a blood pump with an in-built one-way valve at the distal portion thereof “to prevent fluid flow in an opposite direction” (e.g. 8:8-20, Fig. 9: one-way valve 906). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to incorporate a one-way valve at a distal portion of a pump device according to the teachings of Mitze, as taught by Gharib, in order to predictably prevent backflow in a direction opposite to that of pumping (Gharib 8:16-20).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Mitze/Gharib, as applied to Claim 13, and further in view of US 8591393 to Walters.
Regarding Claim 14, Mitze as modified in Claim 13 teaches the device as claimed in claim 13, yet does not teach wherein the coronary infusion port is further attached with a coronary infuser pump. However, Walter teaches an analogous blood pump wherein a port is attached with an infuser pump, in order to infuse medications in the heart pump (e.g. 5:24-45,56-62, Fig. 1A and 12: infusion assembly 150). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to incorporate an infusion pump in a system according to the teachings of Mitze/Gharib, as taught by Walters, in order to predictably infuse medications through the heart pump, as suggested by Walters.
Allowable Subject Matter
Claim 15 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims. Mitze does not teach a coronary infuser pump loaded with a combination of cardio stimulant medicines and other molecules, noting here that the term “loaded” positively recites and requires the cardio stimulant medicines and other molecules.
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/MANOLIS PAHAKIS/Examiner, Art Unit 3796