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 .
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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: “motor drive unit configured to generate a rotation force …” in claim 14
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.
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.
Claims 1 - 14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 is indefinite because it is unclear if the interface circuits are connected to the catheter or not. The claim requires that the battery “supplies” power to the catheter, which requires that the catheter is connected to the circuits, but the claim also recites that the circuits are merely “connectable” to the catheter, which reads on the catheter not being connected. It is thus unclear which state (i.e., connected vs. merely connectable) is required.
Claims 2 - 14 are indefinite by virtue of dependency.
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, 5, 10, 13 - 17, 19, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Randall et al. (US 20080110261) in view of Matsumura et al. (US 2011/0098600).
Regarding claims 1, 15, and 20, Randall shows a catheter interface device comprising:
a plurality of interface circuits (wireless interface 120 and/or wired interface 122, [0049] and fig. 1) connectable to: an imaging catheter (catheter-based ultrasound transducer probes, [0238]) having an ultrasound transmitter and receiver and an external display device for displaying an image based on a signal acquired from the ultrasound transmitter and receiver or the optical transmitter and receiver (display 350, [0059]);
a signal processing circuit (see circuits in fig. 1 and corresponding descriptions thereof) configured to process the signal acquired from the ultrasound transmitter and receiver before the signal is transmitted to the display device;
a battery (“power supply 236 … batteries”, [0053] and fig. 1) that supplies power to the imaging catheter and the signal processing circuit;
a memory that stores a program (“[e]stimate of the remaining battery capacity may be made at the main unit, probe 1105, and/or some other device”, [0221] - the “memory” and “program” are necessarily present in the system), history data indicating battery power consumption for each of a plurality of medical procedures performed using the imaging catheter (“track the characteristics of the battery and its use … the amount of time the battery has been used, as well as the charge and discharge cycles”, [0213]; “… expected probe usage patterns”, [0222] - the tracked characteristics and/or usage patterns are ‘indicative of the power consumption’ as recited), and a battery level indicating remaining power of the battery (battery's current charge state, [0213] - [0214]; remaining battery capacity, [0221] - [0222]);
a display (display 350, [0059]); and
a processor (“[e]stimate of the remaining battery capacity may be made at the main unit, probe 1105, and/or some other device”, [0221] - the “processor” is necessarily present in the system) configured to execute the program to: control the display to display the information regarding the battery charge status (“display … battery charge status, … time the device has left of battery power… low-battery warnings …”, [0200]; “… feedback to the system and display such information to the user regarding the battery's current charge state”, [0213] - [0214]; “display on the main imaging display screen an estimate of the remaining battery capacity based on current and expected probe usage patterns”, [0222]).
The method of use of the system comprises supplying power to the battery, processing the signal, storing the history data and battery level, and displaying the information regarding the battery charge status. The system comprises non-transitory memory storing a program that implements the functions of the system.
Randall fails to show that the information regarding the battery charge status comprises a calculated number of medical procedures that can be performed using the remaining power of the battery based on the history data and the battery level.
Matsumura, in applicant’s field of endeavor of constructional details of operational features of power supplies in medical devices (CPC group A61B2560/0214), discloses a blood testing apparatus. Matsumura teaches information regarding the battery charge status comprises a calculated number of medical procedures that can be performed (abstract; “… display the number of remaining … operations”, [0019]; “… calculates the number of remaining … operations, based on the output of remaining battery level … and the output of memory 15d”, [0066]) using the remaining power of the battery based on the history data (“data of power consumption measured … every time”, [0063]; [0067]) and the battery level (remaining battery level, [0064]).
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 invention of Randall to have the information regarding the battery charge status comprise a calculated number of medical procedures that can be performed using the remaining power of the battery based on the history data and the battery level, as taught by Matsumura, in order to accurately know the number of remaining operations that is reliable, as suggested by Matsumura ([0069]).
Regarding claims 2 and 16, the combined invention of Randall and Matsumura discloses the claimed invention substantially as noted above. Randall further shows the imaging catheter includes a rotation drive unit, and the power from the battery is supplied to the rotation drive unit and the ultrasound transmitter and receiver (rotation, [0238], which comprises use of a ‘drive unit’ as recited).
Regarding claims 3, 5, 17, and 19, the combined invention of Randall and Matsumura discloses the claimed invention substantially as noted above.
Randall fails to show calculating a statistical value that is an average value, a median value, or a mode value of battery power consumption for one medical procedure from the history data, wherein the number of medical procedures is calculated based on the statistical value and the battery level, wherein calculating the number of medical procedures includes dividing the battery level by the statistical value.
Matsumura teaches calculating an average value of battery power consumption for one medical procedure from the history data, wherein the number of medical procedures is calculated by dividing the battery level by the average value (“dividing the remaining battery level … the average of the power consumption … stored in memory…”, [0067]; [0157] - [0158]).
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 invention of Randall to include calculating an average value of battery power consumption for one medical procedure from the history data, wherein the number of medical procedures is calculated by dividing the battery level by the average value, as taught by Matsumura, in order to improve accuracy, as suggested by Matsumura ([0067]).
Regarding claim 10, the combined invention of Randall and Matsumura discloses the claimed invention substantially as noted above. Randall further shows controlling one of the interface circuits to transmit the information regarding the battery charge status to the external display device (“display … battery charge status, … time the device has left of battery power… low-battery warnings …”, [0200]; “… feedback to the system and display such information to the user regarding the battery's current charge state”, [0213] - [0214]; “display on the main imaging display screen an estimate of the remaining battery capacity based on current and expected probe usage patterns”, [0222]).
In the combined invention of the prior art, the information regarding the battery charge status is the calculated number of medical procedures, as discussed above.
Regarding claim 13, the combined invention of Randall and Matsumura discloses the claimed invention substantially as noted above. Randall further shows wherein the interface circuits include a wireless communication interface connectable to the external display device (wireless interface 120, [0049] and fig. 1).
Regarding claim 14, the combined invention of Randall and Matsumura discloses the claimed invention substantially as noted above. Randall further shows a motor drive unit configured to generate a rotation force for rotating the imaging catheter, wherein the processor executes the program to control the motor drive to generate the rotation force (rotation, [0238], which comprises use of a ‘motor drive unit’ as recited).
Claim(s) 4 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Randall and Matsumura as applied to claim 3 above, and further in view of Lisy et al. (US 9,579,060).
Regarding claims 4 and 18, the combined invention of Randall and Matsumura discloses the claimed invention substantially as noted above.
Randall fails to show removing an abnormal value or an outlier from the data before calculating the statistical value.
Lisy, in applicant’s field of endeavor of constructional details of operational features of power supplies in medical devices (CPC group A61B2560/0214), discloses diagnostic devices. Lisy teaches removing an abnormal value or an outlier from the data before calculating the statistical value (“computing a rolling average … with outliers omitted from the computation”, col. 42, lines 50 - 55).
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 combined invention of Randall and Matsumura to include removing an abnormal value or an outlier from the data before calculating the statistical value, as taught by Lisy, in order to avoid skewing the calculation with extreme values, as is well-understood in the art.
Claim(s) 7 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Randall and Matsumura as applied to claim 1 above, and further in view of Maruyama et al. (US 2019/0079461).
Regarding claims 7 and 8, the combined invention of Randall and Matsumura discloses the claimed invention substantially as noted above.
Randall fails to show correcting the information regarding the battery charge status based on a deterioration state of the battery and/or indoor temperature or an in-device temperature.
Maruyama is pertinent to applicant’s field of endeavor of operational features of power supplies. Maruyama teaches correcting the information regarding the battery charge status based on a deterioration state of the battery and/or indoor temperature or an in-device temperature (“the remaining battery power … corrected according to a temperature condition and/or used time (deterioration level of the battery 71)”, [0066]).
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 combined invention of Randall and Matsumura to include correcting the information regarding the battery charge status based on a deterioration state of the battery and/or indoor temperature or an in-device temperature, as taught by Maruyama, in order to improve the robustness of the calculation, as is well-understood in the art.
In the combined invention of the prior art, the information regarding the battery charge status is the calculated number of medical procedures, as discussed above.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Randall and Matsumura as applied to claim 1 above, and further in view of Taniguchi (US 2014/0316193).
Regarding claim 9, the combined invention of Randall and Matsumura discloses the claimed invention substantially as noted above.
Randall fails to show calculating a necessary charging time for charging the battery up to a particular level at which a particular number of medical procedures can be performed without further charging.
Taniguchi discloses capsule endoscopes. Taniguchi teaches calculating a necessary charging time for charging the battery up to a particular level at which a particular number of medical procedures can be performed without further charging (“calculates a charging time needed to increase the remaining capacity of the battery from the current remaining capacity to the necessary remaining capacity”, abstract).
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 combined invention of Randall and Matsumura to include calculating a necessary charging time for charging the battery up to a particular level at which a particular number of medical procedures can be performed without further charging, as taught by Taniguchi, in order to optimize power management, as is understood in the art.
Claim(s) 11 - 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Randall and Matsumura as applied to claim 1 above, and further in view of Adler et al. (US 2012/0310081).
Regarding claims 11 - 12, the combined invention of Randall and Matsumura discloses the claimed invention substantially as noted above. Randall further shows a housing (implicit, the catheter, [0237] - [0238] necessarily includes a housing) including first a first connection port to which a proximal end of the imaging catheter is connectable (wired interface 122, [0049] and fig. 1); and that the external display device is an intravascular image diagnosis apparatus, an angiography apparatus, an external monitor, or an electrocardiograph (implicit, the external display device is at least physically capable of being used in any of the recited diagnostic contexts).
Randall is silent as to the housing including a second connection port to which a light source device for emitting light to the optical transmitter and receiver of the imaging catheter is connectable.
Adler discloses imaging catheters. Adler teaches a housing including a second connection port to which a light source device for emitting light to the optical transmitter and receiver of the imaging catheter is connectable (port … optical communication, [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 combined invention of Randall and Matsumura to include a second connection port to which a light source device for emitting light to the optical transmitter and receiver of the imaging catheter is connectable, as taught by Adler, in order to provide light to the catheter, as is conventional in the art.
Allowable Subject Matter
Claim 6 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.
The following is a statement of reasons for the indication of allowable subject matter: Regarding claim 6, the prior art of record, singly and/or in combination, fails to teach or reasonably suggest the catheter interface device according to claim 1, wherein the processor is configured to execute the program to determine variation in battery power consumption for the medical procedures, and calculate the number of medical procedures as a numerical range corresponding to the variation.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMELIE R DAVIS whose telephone number is (571)270-7240. The examiner can normally be reached Monday-Friday, 9:30 - 6:00 PST.
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/AMELIE R DAVIS/Primary Examiner, Art Unit 3798
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