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 .
Response to Amendment
Claims 1 and 3-21 are currently pending. Claim 2 has been cancelled. Claims 4 and 9 have been amended to overcome the claim objections, claim 1 has been amended to overcome the 35 U.S.C. 112(b) rejection, and claim 1 has been amended to overcome the 35 U.S.C. 101 rejection, directed to or encompassing a human organism, set forth in the Non-Final Office Action mailed on 16 January 2026.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “heating element” in claims 1, 4, and 9, “processing device” in claim 1, “charging element” in claim 6, and “resistive heating elements” in claim 9.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
“heating element” is interpreted as “any suitable element or elements that generate heat, including but not limited to a heat generating thermistor, inductive heating circuitry, resistive heating elements, or other devices or methods of applying heat,” as mentioned in [0106] of the PGPUB
“charging element” is interpreted as “RF to DC or NFC (near field communication) power,” as mentioned in [0051] of the PGPUB
“resistive heating elements” is interpreted as “resistive heating coils” as mentioned in [0014] of the PGPUB
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 1 is 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. Claims 3-21 are further rejected due to their dependency to claim 1.
Claim 1 recites “at least one controller and/or processor configured to one or more of: receive the first temperature, the second temperature, and a heat value relating to the heat applied to the body fluid by the heating element, or calculate a flow rate of the body fluid through the tube based at least on the first temperature, the second temperature, and the heat value” (emphasis added) in lines 14-17. The flow rate is calculated based on the first and second temperatures and the heat value. It is unclear how the controller/processor could calculate the flow rate without receiving the first and second temperature and the heat value. Clarification is requested. For examination purposes, the Examiner interprets lines 14-17 as “at least one controller and/or processor configured to one or more of: receive the first temperature, the second temperature, and a heat value relating to the heat applied to the body fluid by the heating element, and calculate a flow rate of the body fluid through the tube based at least on the first temperature, the second temperature, and the heat value” (emphasis added).
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 3 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 3 recites that the at least one transmitter transmits the flow rate using at least one wireless transmission technology. However, claim 1 recites that the at least one transmitter wirelessly transmits the flow rate to the at least one receiver in lines 15-16. It is inherent that the at least one transmitter utilizes wireless transmission technology to wirelessly transmit data to a receiver and thus claim 3 does not further limit claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claims 1 and 3-21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claim 1 follows.
STEP 1
Regarding claim 1, the claim recites a series of structural elements, including a first temperature sensor. Thus, the claim is directed to a machine, which is one of the statutory categories of invention.
STEP 2A, PRONG ONE
The claim is then analyzed to determine whether it is directed to any judicial exception. The steps of:
a heating element applying heat to the body fluid at a second position along the tube, wherein the heating element applies hat to the body fluid after the body fluid passes the first position; and
at least one controller and/or processor configured to one or more of receive the first temperature sensor, the second temperature sensor, and a heat value relating to the heat applied to the body fluid by the heating element, or; and calculate a flow rate of the body fluid through the tube based at least on the first temperature, the second temperature, and the heat value
set forth a judicial exception. These steps describe a concept performed in the human mind (including an observation, evaluation, judgment, opinion). Thus, the claim is drawn to a Mental Process, which is an Abstract Idea. The heating step also describes the concept of organizing human activity, which is also an Abstract Idea.
STEP 2A, PRONG TWO
Next, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claim fails to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. Claim 1 recites at least one transmitter configured to receive the flow rate and wirelessly transmit the flow rate to at least one receiver, which is merely adding insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)). The transmitting of the flow rate does not provide an improvement to the technological field, the method does not effect a particular treatment or effect a particular change based on the transmitted flow rate, nor does the method use a particular machine to perform the Abstract Idea.
STEP 2B
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the Abstract Idea, the claim recites additional steps of:
a first temperature sensor measuring a first temperature of the body fluid at a first position along the tube, wherein the first temperature senor is configured to be implanted in a human or animal body;
wherein the heating element is configured to be implanted in the human or animal body;
a second temperature sensor measuring a second temperature of the body fluid at a third position along the tube, wherein the second temperature sensor is located along the tube at a location after the body fluid passed the second position, and wherein the second temperature sensor is configured implanted in the human or animal body; and
wherein the at least one transmitter is configured to be implanted in the human or animal body, and wherein the at least one receiver is located external to the human or animal body.
The measuring steps are well-understood, routine and conventional activities for those in the field of medical diagnostics. Further, the providing and recording steps are each recited at a high level of generality such that it amounts to insignificant presolution activity, e.g., mere data gathering step necessary to perform the Abstract Idea. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional step that distinguishes it from well-understood, routine, and conventional data gathering activity engaged in by medical professionals prior to Applicant's invention. Furthermore, it is well established that the mere physical or tangible nature of additional elements such as the obtaining and comparing steps do not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int'l, 134 S.Ct. 2347, 2358-59 (2014)).
Furthermore, the first temperature sensor, heating element, second temperature sensor, controller and/or processing device, transmitter, and receiver, and wherein the first temperature sensor/heating element/second temperature sensor/transmitter is implanted in the human or animal body are well-understood, routine, and conventional, as supported by Column 1 Line 47 – Column 2 Line 7 of Callister et al. ‘026 (US Patent No. 7,087,026 – previously cited).
The device recited in the claim is a generic device comprising generic components configured to perform the abstract idea. The recited temperature sensors, transmitter, and receiver are generic sensors configured to perform pre-solutional data gathering activity and the heating element, controller, and processing device are configured to perform the Abstract Idea. According to section 2106.05(f) of the MPEP, merely using a computer as a tool to perform an abstract idea does not integrate the Abstract Idea into a practical application.
Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. Unlike the eligible claim in Diehr in which the elements limiting the exception are individually conventional, but taken together act in concert to improve a technical field, the claim here does not provide an improvement to the technical field. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claim as a whole does not amount to significantly more than the exception itself. The claim is therefore drawn to non-statutory subject matter.
The dependent claims also fail to add something more to the abstract independent claims. Claims 3, 4, 8, 9, and 11-13 add to the Abstract Idea and claims 5-7, 10, and 14-21 recite additional elements that do not add anything significantly more. The steps recited in the independent claims maintain a high level of generality even when considered in combination with the dependent claims.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 3, 10, 19, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Callister et al. ‘026 (US Patent No. 7,087,026 – previously cited) in view of Kostner et al. ‘433 (US Pub No. 2017/0184433 – previously cited).
Regarding claim 1, Callister et al. ‘026 teaches a flow meter for determining a flow rate of body fluid through a tube (Title, Abstract), the flow meter comprising the following:
a first temperature sensor (Fig. 4 temperature sensor 39 and Column 6 Line 37 – Column 7 Line 3) measuring a first temperature of the body fluid at a first position along the tube, wherein the first temperature sensor is configured to be implanted in a human or animal body (Fig. 5 upstream temperature T1 and Column 11 Lines 19-46);
a heating element (Fig. 4 heat exchanger 20 and Column 6 Line 37 – Column 7 Line 3) applying heat to the body fluid at a second position along the tube, wherein the heating element applies heat to the body fluid after the body fluid passes the first position, and wherein the heating element is configured to be implanted in the human or animal body (Fig. 1 heat exchanger 20a and Column 11 Lines 19-46, Column 5 Lines 36-41);
a second temperature sensor (Fig. 4 temperature sensor 41 and Column 6 Line 37 – Column 7 Line 3) measuring a second temperature of the body fluid at a third position along the tube, wherein the second temperature sensor is located along the tube at a location after the body fluid passes the second position, and wherein the second temperature sensor is configured to be implanted in the human or animal body (Fig. 5 downstream temperature T2 and Column 11 Lines 19-46);
at least one controller and/or processor (Fig. 4 controller 220 ) configured to one or more of: receive the first temperature (Column 7 Lines 4-7), the second temperature (Column 6 Lines 25-28), and a heat value relating to the heat applied to the body fluid by the heating element (Column 6 Lines 56-61), or calculate a flow rate of the body fluid through the tube based at least on the first temperature, the second temperature, and the heat value (Column 11 Lines 19-46).
Callister et al. ‘026 teaches all of the elements of the current invention as mentioned above except for at least one transmitter configured to receive the flow rate and wirelessly transmit the flow rate to at least one receiver, wherein the at least one transmitter is configured to be implanted in the human or animal body, and wherein the at least one receiver is located external to the human or animal body.
Kostner et al. ‘433 a flow sensor that comprises a transmitting for transmitting data measured by the flow sensor (e.g., flow velocity, volumetric flow rate, or mass flow rate of the medium) in a wireless fashion to a remote receiver ([0056]). The flow sensor 1 may be a stand-alone device, but may also form a part of an implant or a medical device such as a catheter or a micro dosing pump ([0042]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the flow meter of Callister et al. ‘026 to include at least one transmitter configured to receive the flow rate and wirelessly transmit the flow rate to at least one receiver, wherein the at least one transmitter is configured to be implanted in the human or animal body, and wherein the at least one receiver is located external to the human or animal body as Kostner et al. ‘433 teaches that this will aid in transmitting data to a remote device.
Regarding claim 3, Callister et al. ‘026 in view of Kostner et al. ‘433 teaches all of the elements of the current invention as mentioned above except for wherein the at least one transmitter transmits the flow rate using at least one wireless transmission technology.
Kostner et al. ‘433 a flow sensor that comprises a transmitting for transmitting data measured by the flow sensor (e.g., flow velocity, volumetric flow rate, or mass flow rate of the medium) in a wireless fashion to a remote receiver ([0056]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the at least one transmitter of Callister et al. ‘026 to include transmitting the flow rate using at least one wireless transmission technology as Kostner et al. ‘433 teaches that this will aid in transmitting data to a remote device.
Regarding claim 10, Callister et al. ‘026 teaches wherein the first temperature sensor and the second temperature sensor each include at least one of: a thermistor, a resistive temperature detector, a semiconducting temperature sensor, and a thermocouple (Column 5 Lines 53-58).
Regarding claim 19, Callister et al. ‘026 teaches wherein the tube is a catheter (Fig. 4 catheter 10 and Column 5 Lines 53-58).
Regarding claim 20, Callister et al. ‘026 teaches wherein the catheter is a ventricular catheter (Column 8 Lines 58-60; “…may be used for monitoring of right ventricular pressures or for other access to the right ventricle.”).
Claims 4-6 are rejected under 35 U.S.C. 103 as being unpatentable over Callister et al. ‘026 in view of Kostner et al. ‘433 further in view of Penner et al. ‘028 (US Pub No. 2010/0106028 – previously cited).
Regarding claims 4-6, Callister et al. ‘026 in view of Kostner et al. ‘433 teaches all of the elements of the current invention as mentioned above except for at least one power system in communication with the at least one controller and/or processor such that the heating element is operative to apply the heat in response to a power control command from the at least one controller and/or processor;
wherein the power system includes at least one battery for storing an electrical charge therein; and
wherein the power system includes at least one charging element for generating an electrical charge.
Penner et al. ‘028 teaches an implantable device that can be used to charge a rechargeable battery within a device ([0027]). By placing the source and target transducers 48,58 in close proximity to each other, the attenuation loss associated with the rapid fall off of acoustic energy in the near field is reduced, resulting in an increase in charge coupling efficiency. This increase in efficiency reduces the overall time required to recharge the battery 46, and subjects the body to less energy than would otherwise be required to recharge the battery 46 via an external recharging approach with the source ultrasonic transducer transmitting the charging energy directly into the body. This results in a higher intensity field in the vicinity of the implanted device 12 while maintaining a lower overall energy flux transmitted into the body. In addition, because the source transducer 48 is located in close proximity to the target transducer 58, a smaller portion of the transmitted acoustic energy is absorbed and/or scattered within the body, resulting in more efficient charging with reduced body tissue and fluid heating ([0031]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the flow meter of Callister et al. ‘026 in view of Kostner et al. ‘433 to include at least one power system in communication with the controller such that the heating element is operative to apply the heat in response to a power control command from the controller; wherein the power system includes at least one battery for storing an electrical charge therein; and wherein the power system includes at least one charging element for generating an electrical charge as Penner et al. ‘028 teaches that this will aid in more efficient charging with reduced body tissue and fluid heating.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Callister et al. ‘026 in view of Kostner et al. ‘433 further in view of Penner et al. ‘028 further in view of Krishnan et al. ‘306 (US Pub No. 2023/0248306 – previously cited).
Regarding claim 7, Callister et al. ‘026 in view of Kostner et al. ‘433 further in view of Penner et al. ‘028 teaches all of the elements of the current invention as mentioned above except for wherein the at least one charging element includes a Near-field Communication component.
Krishnan et al. ‘306 teaches flow sensor comprising a near-field communication (NFC) based charging circuit including a flexible antenna configured to receive electromagnetic energy from a wireless charging station ([0100]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the at least one charging element of Callister et al. ‘026 in view of Kostner et al. ‘433 further in view of Penner et al. ‘028 to include a Near-field Communication component as Krishnan et al. ‘306 teaches that this will aid in receiving electromagnetic energy from a wireless charging station.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Callister et al. ‘026 in view of Kostner et al. ‘433 further in view of Tani ‘466 (US Pub No. 2021/0267466 – previously cited).
Regarding claim 8, Callister et al. ‘026 in view of Kostner et al. ‘433 teaches all of the elements of the current invention as mentioned above except for wherein at least one receiver is also configured to wirelessly communicate with the at least one controller and/or processor, another different controller and/or processor, or both for generating at least one output signal based on the flow rate.
Tani ‘466 teaches blood flow rate data is transmitted from a blood flow rate probe to a display device via wireless communication (Fig. 1 and [0037]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the flow meter of Callister et al. ‘026 in view of Kostner et al. ‘433 to include at least one receiver is also configured to wirelessly communicate with the at least one controller and/or processor, another different controller and/or processor, or both for generating at least one output signal based on the flow rate as Tani ‘466 teaches that this will aid in displaying blood flow to doctors at times in need ([0002]), such as during an operation ([0037]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Callister et al. ‘026 in view of Kostner et al. ‘433 further in view of Taylor et al. ‘601 (US Pub No. 2021/0059601 – previously cited).
Regarding claim 9, Callister et al. ‘026 in view of Kostner et al. ‘433 teaches all of the elements of the current invention as mentioned above except for wherein the heating element includes at least one of: a heat generating thermistor, inductive heating circuitry, and resistive heating elements.
Taylor et al. ‘601 teaches a heat exchanger may also take a variety of different forms, such as, but not limited to, an electrical resistance heater ([0035]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the heating element of Callister et al. ‘026 in view of Kostner et al. ‘433 to include at least one of: a heat generating thermistor, inductive heating circuitry, and resistive heating elements as Taylor et al. ‘601 teaches that the heat exchanger may take a variety of forms, including an electrical resistance heater, as this would be choosing from a finite, number of identified, predictable solutions, with a reasonable expectation of success.
Claims 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Callister et al. ‘026 in view of Kostner et al. ‘433 further in view of Feagler et al. ‘840 (US Pub No. 2021/0310840 – previously cited).
Regarding claim 11, Callister et al. ‘026 in view of Kostner et al. ‘433 teaches all of the elements of the current invention as mentioned above except for wherein the calculating of the flow rate of the body fluid is based on maintaining a constant temperature differential over a set period of time between the first temperature and the second temperature, such that a power requirement for the heating element to maintain the constant temperature differential is provided for calculating the flow rate.
Feagler et al. ‘840 teaches a flow probe that includes a characterization of the transfer of heat to the liquid as a function of power input to a heating element. As a result, the flow probe can be configured to maintain a targeted or constant temperature differential between the heated and unheated probes, or a downstream temperature sensor and an upstream temperature sensor, by continuously, intermittently, or periodically varying heater power. The flow rate can be inferred from the power provided to the heating element to maintain this targeted temperature difference ([0058]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the calculating of the flow rate of the body fluid of Callister et al. ‘026 in view of Kostner et al. ‘433 to include being based on maintaining a constant temperature differential over a set period of time between the first temperature and the second temperature, such that a power requirement for the heating element to maintain the constant temperature differential is provided for calculating the flow rate as Feagler et al. ‘840 teaches that this will aid in improving the performance of the flow probe ([0058]).
Regarding claim 12, Callister et al. ‘026 in view of Kostner et al. ‘433 teaches all of the elements of the current invention as mentioned above except for wherein the calculating of the flow rate of the body is based on using a defined amount of power to power the heating element and measuring a temperature differential between the first temperature and the second temperature, such that the defined amount of power is provided for calculating the flow rate.
Feagler et al. ‘840 teaches a flow probe that includes a characterization of the transfer of heat to the liquid as a function of power input to a heating element. As a result, the flow probe can be configured to maintain a targeted or constant temperature differential between the heated and unheated probes, or a downstream temperature sensor and an upstream temperature sensor, by continuously, intermittently, or periodically varying heater power. The flow rate can be inferred from the power provided to the heating element to maintain this targeted temperature difference ([0058]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the calculating of the flow rate of the body fluid of Callister et al. ‘026 in view of Kostner et al. ‘433 to include being based on using a defined amount of power to power the heating element and measuring a temperature differential between the first temperature and the second temperature, such that the defined amount of power is provided for calculating the flow rate as Feagler et al. ‘840 teaches that this will aid in improving the performance of the flow probe ([0058]).
Claims 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Callister et al. ‘026 in view of Kostner et al. ‘433 further in view of Hyde et al. ‘936 (US Pub No. 2012/0238936 – previously cited).
Regarding claim 13, Callister et al. ‘026 in view of Kostner et al. ‘433 teaches all of the elements of the current invention as mentioned above except for wherein the tube is a shunt, wherein the flow meter is connected to the shunt and a bi-compartmental valve, wherein the bi-compartmental valve is configured to modulate the flow rate of the body fluid from a first location along the shunt, to a second location along the shunt.
Hyde et al. ‘936 teaches an implantable device that includes one or more flow-regulating devices that includes at least one valve assemblies having one or more of a housing, inlet and outlet ports, one-way valves, two-way valves, shunts, catheters, or the like ([0069]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the tube of Callister et al. ‘026 in view of Kostner et al. ‘433 to include being a shunt, wherein the flow meter is connected to the shunt and a bi-compartmental valve, wherein the bi-compartmental valve acts is configured to modulate the flow rate of the body fluid from a first location along the shunt, to a second location along the shunt as Hyde et al. ‘936 teaches that this will aid in regulating flow.
Regarding claim 14, Callister et al. ‘026 teaches wherein the first location is one or more patient brain ventricle (Column 6 Lines 10-11; “…through the right ventricle RV…”).
In the alternative, Hyde et al. ‘936 teaches wherein the first location is one or more patient ventricle of the brain ([0063]; “cerebral ventricle”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first location of Callister et al. ‘026 in view of Kostner et al. ‘433 further in view of Hyde et al. ‘936 to include being one or more patient brain ventricle as Hyde et al. ‘936 teaches that this will aid in detecting a biomarker profile of CSF to monitor a specific disease state, pathology, or condition ([0001]).
Regarding claim 15, Callister et al. ‘026 teaches wherein the second location is a fluid receiver (Column 11 Lines 40-41; “…the volume of blood or other fluid flowing pas the heat exchanger…”; Heat exchanger 20a in Fig. 5 is at the second location. Fluid flows through the heat exchanger, which is interpreted as a fluid receiver.).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Callister et al. ‘026 in view of Kostner et al. ‘433 further in view of Hyde et al. ‘936 further in view of Browd et al. ‘938 (US Pub No. 2012/0302938 – previously cited).
Regarding claim 16, Callister et al. ‘026 in view of Kostner et al. ‘433 further in view of Hyde et al. ‘936 teaches all of the elements of the current invention as mentioned above except for wherein the bi-compartmental valve comprises a reservoir for transcutaneous tapping.
Browd et al. ‘938 teaches a drainage system in a catheter system that removes excess body fluid with a valve device ([0052]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the bi-compartmental valve of Callister et al. ‘026 in view of Kostner et al. ‘433 further in view of Hyde et al. ‘936 to include a reservoir for transcutaneous tapping as Browd et al. ‘938 teaches that this will aid in removing excess body fluid.
Claims 17 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Callister et al. ‘026 in view of Kostner et al. ‘433 further in view of Hyde et al. ‘936 further in view of Krishnan et al. ‘306.
Regarding claims 17 and 18, Callister et al. ‘026 in view of Kostner et al. ‘433 further in view of Hyde et al. ‘936 teaches all of the elements of the current invention as mentioned above except for wherein the shunt is a ventriculoperitoneal shunt; and
wherein the shunt is a ventriculoperitoneal shunt for treatment of hydrocephalus.
Krishnan et al. ‘306 teaches using a commercially available ventriculoperitoneal (VP) shunt to regulate CSF flow ([0114]), which are essential components of clinical treatment for hydrocephalus ([0061]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the shunt of Callister et al. ‘026 in view of Kostner et al. ‘433 further in view of Hyde et al. ‘936 to include being a ventriculoperitoneal shunt; and wherein the shunt is a ventriculoperitoneal shunt for treatment of hydrocephalus as Krishnan et al. ‘306 teaches that VP shunts are commercially available and are essential components of clinical treatments of hydrocephalus.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Callister et al. ‘026 in view of Kostner et al. ‘433 further in view of Krishnan et al. ‘306.
Regarding claim 21, Callister et al. ‘026 in view of Kostner et al. ‘433 teaches all of the elements of the current invention as mentioned above except for wherein the catheter is a peritoneal catheter.
Krishnan et al. ‘306 teaches a catheter that is most commonly used for treatment for hydrocephalus with diversion of CSF from the ventricles to the peritoneal cavity ([0062]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the catheter of Callister et al. ‘026 in view of Kostner et al. ‘433 to include being a peritoneal catheter as Krishnan et al. ‘306 teaches that this is most commonly used for treatment for hydrocephalus.
Response to Arguments
Applicant argues that the recited claims improve safety and efficacy by including implantable components of CSF flow rate monitoring using components that can be implanted, components that are not required to be in contact with the body fluid being measured, and by combining and integrating functionality allowing for wireless charging and for wireless data transmission and therefore cannot be practically performed in the human mind. It is noted that the heating step is seen as organizing human activity, which is another abstract idea. The receiving and calculating steps are seen as a mental process as each of these steps could be performed mentally or by hand. Receiving data could be a user reading data points and “mentally receiving” the data. Calculating the flow rate could be a user mentally calculating the flow rate by using the first and second temperatures and heat value. As such, Applicant’s arguments are not persuasive and the 35 U.S.C. 101 rejection has been maintained.
Applicant’s arguments with respect to the 35 U.S.C. 102(a)(1) rejection of claim 1 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Grinstein et al. ‘234 (US Pub No. 2013/0041234) teaches a flow rate meter.
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.
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/AURELIE H TU/ Primary Examiner, Art Unit 3791
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