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
Amendments to claims 1, 21 of 2/5/2026 acknowledged and entered.
Response to Arguments
Applicant’s arguments, see p. , filed 2/5/2026, with respect to the rejection(s) of claim(s) 1/21 under USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Govari.
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: a suction device in claim 2 and a display device in claim 13.
Regarding Claim 2, “a suction device” is a generic placeholder with the ascribed function “to remove fluid from the anatomic site resulting in removed fluid”. Neither subject nor function contain a structural recitation, and as such will be interpreted as the device of para [0058] or any functional equivalents thereof.
Regarding Claim 13, “a display device” is a generic placeholder with the ascribed function “to provide a user a view of the first temperature”. Neither subject nor function contain a structural recitation, and as such will be interpreted as the device of para [0054] or any functional equivalents thereof.
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 § 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 1-5, 9, 13-15, 21 is/are rejected under 35 U.S.C. 103 as being obvious over Kucklick (WO 2007035574 A1) in view of Germain (US 20140303551 A1) and Dickhans (EP 3412237 B1) and Govari (JP 2017113568 A).
Regarding Claim 1, Kucklick teaches A therapy delivery system comprising:
a scope configured to provide a view of an anatomic site ([0024] arthroscope visualizes the surgical field);
an energy delivery device configured to deliver therapy energy to the anatomic site ([0025] instruments can include energy delivery devices such as ablation devices, arthroscopes, endoscopes, awls, picks, shavers, etc.);
a first irrigation conduit configured to transfer fluid to the anatomic site (fig. 1, element 9, [0029] inflow lumen allows for fluid from a source to flow to surgical site);
a second irrigation conduit physically separate from the first irrigation conduit and configured to transfer fluid away from the anatomic site (fig. 3-8, element 21-24, [0029], inflow and outflow lumen are separated by ribs 25);
a first temperature sensor (fig. 2, element 8) situated to provide first temperature data associated with the anatomic site ([0028] sensor collects temperature of fluid at the surgical site);
at least one pump in fluid communication with the first irrigation conduit ([0030], arthroscopic pump is a part of the fluid delivery system);
at least one of a fluid cooler (fig. 9/10a, element 11 [0033]) in fluid communication with the fluid and configured to transfer cooled fluid into the anatomic site or a fluid heater in fluid communication with the fluid and configured to transfer heated fluid into the anatomic site;
an actuated valve (fig. 11, element 42, [0034]) configured to receive the heated fluid and/or the cooled fluid and provide the fluid to the first conduit;
and control circuitry (fig. 9, element 12) electrically coupled to receive the first temperature data, the control circuitry configured to maintain the temperature at the anatomic site below a threshold value ([0038], temperature at the surgical site is maintained below the threshold temperature 113 degrees F by inflow of cooled fluid), based at least in part on the computed temperature ([0038], temperature sensor indicates the temperature change by the application of the ablation device and causes the fluid inflow when the combined temperature exceeds the threshold value).
Kucklick does not explicitly teach The control circuitry configured to maintain the temperature at the anatomic site by
Determining a computed temperature of the anatomic site based at least in part on the first temperature data, the therapy energy delivered to the anatomic site, and an outflow of the fluid from the anatomic site; and
independently controlling a flow rate of fluid to the anatomic site and a flow rate of fluid away from the anatomic site
However, Dickhans teaches The control circuitry being configured to maintain temperature at the anatomic site by independently controlling a flow rate of fluid to the anatomic site ([0043, 47], Pressure and flow rate within the system may be altered to maintain temperature within the desired range);
However, Germain teaches The control circuitry being configured to maintain homeostasis at the anatomic site (fig. 16, element 545, [0076], fluid management system controller 545 controls intra-cavity pressure during a surgical procedure by separately controlling inflow pump 546a and outflow pump 546b) by independently controlling a flow rate of fluid to the anatomic site and a flow rate of fluid away from the anatomic site
However, Govari teaches Determining a computed temperature of the anatomic site based at least in part on the first temperature data, the therapy energy delivered to the anatomic site, and an outflow of the fluid from the anatomic site (p. 7, para. 5, processor estimates tissue temperature using average value of sensed temperature, irrigation fluid flow rate, and/or ablation current parameters);
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the irrigation system of Kucklick to modify temperature via fluid flow as taught in Dickhans in order to maintain a constant temperature at the operation site (Dickhans [0043]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the irrigation system of Kucklick to include a separate inflow/outflow controller as taught in Germain in order to maintain a constant pressure at the operation site (Germain [0076]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the irrigation system of Kucklick to calculate temperature as taught in Govari in order to determine whether the current parameters are sufficient given the sensed temperature (Govari p. 7, para. 5).
Regarding Claim 2, Kucklick in view of Dickhans and Germain and Govari teaches The system of claim 1,
Further, Kucklick teaches the system further comprising:
a suction device (fig. 12, element 49) configured to remove fluid from the anatomic site resulting in removed fluid ([0030] fluid evacuation is performed by either vacuum, siphon, or gravity);
and wherein the second irrigation conduit is in fluid communication with the suction device to receive the removed fluid and configured to transfer the removed fluid away from the anatomic site ([0029-30] outflow lumen carries fluid away; sheath is multi-lumen);
wherein the first temperature data indicates a third temperature of the removed fluid ([0028, 35-37] contemplates measuring removed fluid temperature).
Regarding Claim 3, Kucklick in view of Dickhans and Germain and Govari teaches The system of claim 1,
Further, Kucklick teaches the system wherein the first temperature data indicates the second temperature ([0028, 35-37] removed fluid temp is measured both at the site per [0028] and in the handle per [0035-37], either could be interpreted to be a “second” or “third” temperature reading, as applicant does not explicitly define what the second temperature measures in claims or spec, only that it relates to the anatomic site in some way).
Regarding Claim 4, Kucklick in view of Dickhans and Germain and Govari teaches The system of claim 1,
Further, Kucklick teaches they system further comprising:
the fluid cooler (fig. 9, element 11) in fluid communication with the fluid, the fluid cooler configured to receive and cool a first portion of the fluid resulting in cooled fluid ([0032-34] chilling module can comprise a number of devices);
wherein the control circuitry adjusts a fourth temperature to which the fluid cooler cools the cooled fluid based on the first temperature data ([0032] control system automatically activates cooler in response to measured site temperature. Activation/deactivation changes the temperature of the cooled fluid).
Regarding Claim 5, Kucklick in view of Dickhans and Germain and Govari teaches The system of claim 4,
Further, Kucklick teaches the system further comprising:
a third irrigation conduit in fluid communication with the fluid, the third irrigation conduit configured to receive a second portion of the fluid (fig. 11, element 43, [0034] warm fluid is kept in a separate source to be mixed with cooled fluid);
wherein the first irrigation conduit is configured to receive a mixture of both the second portion of the fluid and the cooled fluid ([0034] warm and cool fluid are mixed via the mixing valve 42).
Regarding Claim 9, Kucklick in view of Dickhans and Germain and Govari teaches The system of claim 1,
Further, Kucklick teaches the system wherein the control circuitry is configured to adjust a pump rate of the pump based on the first temperature data ([0030,33], anthroscopy pump is used).
Regarding Claim 10, Kucklick in view of Dickhans and Germain and Govari teaches The system of claim 9,
Kucklick does not explicitly teach a system wherein the control circuitry is further configured to adjust a pump rate of the pump based on the pressure data.
However, Shelton teaches a system
wherein the control circuitry is further configured to adjust a pump rate of the pump based on the pressure data ([0021], fluid inflow/outflow and pressure data are monitored and fluid flow rate is adjusted in response).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the scope of Kucklick to adjust flow rate in response to pressure as taught in Shelton in order to prevent damage to a patient’s body (Shelton [0019]).
Regarding Claim 13, Kucklick in view of Dickhans and Germain and Govari teaches The system of claim 1,
Further, Kucklick teaches the system further comprising a display device (fig. 13, element 57) electrically coupled to the control circuitry, the display device configured to provide a user a view of the first temperature ([0036] display shows current temperature).
Regarding Claim 14, Kucklick in view of Dickhans and Germain and Govari teaches The system of claim 13,
Further, Kucklick teaches the system further comprising an alerting device configured to generate an audio, visual, or haptic feedback (fig. 13, element 55) indicating that the first temperature has exceeded or is about to exceed a threshold temperature ([0036] fig. 13 depicts a temperature warning device).
Regarding Claim 15, Kucklick in view of Dickhans and Germain and Govari teaches The system of claim 13,
Further, Kucklick teaches the system wherein the display provides a user interface that is configured to receive data indicating a second temperature set point below which to maintain the anatomic site and the control circuitry automatically operates to manage the temperature of the anatomic site between first and second temperature set points ([0032,37] safe temperature is assumed to be 113 F, but may be set by a user, chilling module activates so as to not exceed this temperature automatically).
Further, Dickhans teaches a system with a first temperature set point above which to maintain the anatomic site ([0043], lower bounds of temperature range).
Regarding Claim 21, Kucklick teaches A therapy delivery system comprising:
a scope configured to provide a view of an anatomic site ([0024] arthroscope visualizes the surgical field);
an energy delivery device configured to provide an electrical or optical energy to the anatomic site ([0025] instruments can include energy delivery devices such as ablation devices, arthroscopes, endoscopes, awls, picks, shavers, etc.);
at least one actuated valve (fig. 11, element 42, [0034] mixing valve);
a first irrigation conduit in fluid communication with a first portion of the fluid and the at least one actuated valve, the first irrigation conduit configured to provide the first portion directly to the actuated valve resulting in direct fluid (fig. 1, element 9, [0029] inflow lumen allows for fluid from a source to flow to surgical site);
a fluid cooler (fig. 9, element 11) in fluid communication with a second portion of the fluid and the at least one actuated valve, the fluid cooler configured to cool a second portion of the fluid based on a temperature setting of the fluid cooler resulting in cooled fluid ([0032-34] chilling module can comprise a number of devices);
a second irrigation conduit physically separate from the first irrigation conduit and in fluid communication with the actuated valve, the second irrigation conduit configured to receive a mixed fluid that is mixture of the cooled fluid and the direct fluid, the second irrigation conduit configured to transfer the mixed fluid to the anatomic site (fig. 11, a fluid line runs from the mixing valve 42 to the scope);
a first temperature sensor (fig. 2, element 8) situated to provide first temperature data associated with the anatomic site ([0028] sensor collects temperature of fluid at the surgical site);
at least one pump in fluid communication with the first irrigation conduit ([0030], arthroscopic pump is a part of the fluid delivery system);
and control circuitry electrically coupled to the first temperature sensor, the control circuitry configured to receive the first temperature data and manage at least one of the pressure or the temperature at the anatomic site, based at least in part on the computed temperature ([0038], temperature sensor indicates the temperature change by the application of the ablation device and causes the fluid inflow when the combined temperature exceeds the threshold value)..
Kucklick does not explicitly teach The control circuitry being configured to maintain the temperature at the anatomic site by
Determining a computed temperature of the anatomic site based at least in part on the first temperature data, the therapy energy delivered to the anatomic site, and an outflow of the fluid from the anatomic site; and
independently controlling a flow rate of fluid to the anatomic site and a flow rate of fluid away from the anatomic site
However, Dickhans teaches The control circuitry being configured to maintain temperature at the anatomic site by independently controlling a flow rate of fluid to the anatomic site ([0043, 47], Pressure and flow rate within the system may be altered to maintain temperature within the desired range);
However, Germain teaches The control circuitry being configured to maintain the homeostasis at the anatomic site (fig. 16, element 545, [0076], fluid management system controller 545 controls intra-cavity pressure during a surgical procedure by separately controlling inflow pump 546a and outflow pump 546b) by independently controlling a flow rate of fluid to the anatomic site and a flow rate of fluid away from the anatomic site
However, Govari teaches Determining a computed temperature of the anatomic site based at least in part on the first temperature data, the therapy energy delivered to the anatomic site, and an outflow of the fluid from the anatomic site (p. 7, para. 5, processor estimates tissue temperature using average value of sensed temperature, irrigation fluid flow rate, and/or ablation current parameters);
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the irrigation system of Kucklick to modify temperature via fluid flow as taught in Dickhans in order to maintain a constant temperature at the operation site (Dickhans [0043]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the irrigation system of Kucklick to include a separate inflow/outflow controller as taught in Germain in order to maintain a constant pressure at the operation site (Germain [0076]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the irrigation system of Kucklick to calculate temperature as taught in Govari in order to determine whether the current parameters are sufficient given the sensed temperature (Govari p. 7, para. 5).
Claim(s) 6-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kucklick in view of Dickhans and Germain and Govari as applied to claim 4 in view of Kim (US 20210338478 A1).
Regarding Claim 6, Kucklick in view of Dickhans and Germain and Govari teaches The system of claim 4,
Kucklick in view of Dickhans and Germain and Govari does not explicitly teach a system further comprising:
the fluid heater in fluid communication with the fluid, the fluid heater situated to receive and heat a third portion of the fluid resulting in heated fluid;
wherein the first irrigation conduit is configured to receive a mixture of both the heated and cooled fluid.
However, Kim teaches a fluid heater (fig. 8b, element 280) in fluid communication with the fluid, the fluid heater situated to receive and heat a third portion of the fluid resulting in heated fluid ([0268] heater may surround reservoirs);
wherein the first irrigation conduit is configured to receive a mixture of both the heated and cooled fluid ([0228] fluid heaters act independently and may receive heated or cooled fluid).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the reservoir of Kucklick to include a heater as taught in Kim in order to prevent freezing of fluids (Kim [0267]).
Regarding Claim 7, Kucklick in view of Dickhans, Germain and Govari and Kim teaches The system of claim 6,
Kucklick further teaches one wherein the control circuitry is configured to alter a physical state of the actuated valve based on the first temperature data ([0034] mixing valve 42 is disposed to mix cooled and warm fluid based on the temperature of the anatomical site).
Regarding Claim 8, Kucklick in view of Dickhans, Germain and Govari and Kim teaches The system of claim 7,
Kucklick teaches one further comprising:
a second temperature sensor situated to determine a fifth temperature of fluid out of the actuated valve;
wherein the control circuitry is further configured to adjust respective temperature settings of the fluid heater and the fluid cooler based on the fifth temperature ([0034] the temperature of the resulting mixed fluid is controlled by control system 12).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kucklick in view of Dickhans and Germain and Govari as applied to claim 9 in view of Park (US 20190209368 A1).
Regarding Claim 11, Kucklick in view of Dickhans and Germain and Govari teaches The system of claim 9,
Kucklick does not explicitly teach a system further comprising:
a flow sensor situated to determine a flow rate of fluid from the pump, the flow sensor electrically coupled to the control circuitry;
wherein the control circuitry is further configured to adjust the rate of the pump based on the flow rate.
However, Park teaches a system further comprising:
a flow sensor situated to determine a flow rate of fluid from the pump, the flow sensor electrically coupled to the control circuitry;
wherein the control circuitry is further configured to adjust the rate of the pump based on the flow rate ([0130], flow meters can be provided to measure flow rate of coolant).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the scope of Kucklick to include a flow meter as taught in Park in order to detect leaks and maintain temperature within a desired range (Park [0131])
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kucklick in view of Dickhans and Germain and Govari as applied to claim 9 in view of LISA (DE 202017102316).
Regarding Claim 12, Kucklick in view of Dickhans and Germain and Govari teaches The system of claim 1,
Kucklick in view of Dickhans and Germain and Govari does not explicitly teach a system wherein the control circuitry is configured to adjust, based on the first temperature data, a setting of the energy delivery device to manage a temperature of the anatomic site.
However, LISA teaches a system wherein the control circuitry is configured to adjust, based on the first temperature data, a setting of the energy delivery device to manage a temperature of the anatomic site (p. 3, para. 1 laser light is decoupled or reduced until temperature is reduced at critical levels).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the scope of Kucklick to modulate the intensity of the energy applicator as taught in LISA in order to reduce the risk of unintentional thermal damage to surrounding tissue (LISA p. 2, para. 7).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Lee (US 20200253659 A1) further teaches sensing pressure at an anatomic site ([0038]).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIMOTHY TUAN LUU whose telephone number is (703)756-4592. The examiner can normally be reached Monday-Tuesday, Thursday-Friday.
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/TIMOTHY TUAN LUU/Examiner, Art Unit 3795
/MICHAEL J CAREY/Supervisory Patent Examiner, Art Unit 3795
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