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
This office action is in response to the amendment filed on 6/5/2025. Currently claims 19-36 are pending.
Response to Arguments
Applicant’s arguments, see pg. 5, filed 6/5/2025, with respect to the previous objections of claims 20-22 have been fully considered and are persuasive. The previous objections of claims 20-22 has been withdrawn.
Applicant's arguments, see pgs. 5-7 filed 6/5/2025, with respect to the previous rejection of claims 19-34 under 35 USC 112(b) for indefiniteness have been fully considered but they are not persuasive.
The crux of applicant’s arguments is that when the claims are read in light of the specification, one of ordinary skill would understand that the limitations of:
“a first sensor configured to monitor a parameter at a source and to generate first parameter data”
“a second sensor configured to monitor the parameter at a treatment head and to generate second parameter data”.
in claim 17 to require both a source and a treatment head.
Also applicant argues, that one of ordinary skill would understand the limitations: determine/ determining “whether a differential of the first parameter data and the second parameter data exceeds a predetermined value” recited in claims 17 and 27 to be claiming a difference between the first and second parameter data.
And finally, one of ordinary skill would understand that the limitation of:
“determining whether a differential of the first parameter data or the second parameter data exceeds a predetermined value” recited in claim 28 is performed by the controller.
Applicant argues that this is clear when the claims are read in light of the specification this is clear to one of ordinary skill. Applicant supports this assertion by citing sections of disclosure as providing support. In particular, in the applicant’s arguments on pgs. 5-7 received on 6/5/2025, applicant points out specific embodiments disclosed as support for why one of ordinary skill would make these interpretations. Applicant cites pgs. 14-15 of applicant’s specification which describes a laser system that includes a source and head as evidence that it is clear both the source and head are being claimed; cites pg. 31 of applicant’s specification which discloses an algorithm as controlling the method as evidence that it is clear that the controller controls the step of “determining whether a differential of the first parameter data or the second parameter data exceeds a predetermined value” and cites pg. 31 as evidence that it is clear a differential of the first parameter and the second parameter as requiring a difference between the first and second parameter.
Finally, applicant also argues that the previous 112 rejection of claim 28 for the limitation “the differential of the first parameter data or the second parameter data exceeds the predetermined value” lacking antecedent basis is improper because it is clear that “the differential” is referring to the previously recited “a differential of the first parameter data and the second parameter data exceeds a predetermined value”
As applicant argues:
“The claims first introduce the step of "determining whether a differential of the first parameter data and the second parameter data exceeds a predetermined value," and then refer to "the differential” in the context of modifying an operational parameter. The antecedent basis is clear: "the differential" refers to the previously determined difference between the first and second parameter data. A person of ordinary skill in the art would not be confused by this usage, as it is standard practice to refer back to a previously introduced concept in this manner.
For Claim 19, the "source" is described as the origin of the laser or energy (spec. at p. 15: "Laser system 112 can include one or more solid state lasers...that generate laser light that is delivered to a target, such as the skin of a patient or other suitable targets."). The "treatment head" is the point of application to the patient (spec. at p. 14: "treatment head 104 can include a grip suitable for an operator and one or more physical connections to a robotic movement system..."). The sensors are described as being positioned to monitor parameters at these respective locations (spec. at p. 28: "By measuring laser energy at both treatment head 104 and at laser system 112, the attenuation within the optical path of connector 114 can be determined..."). The "differential" is the difference between two measured values (spec. at p. 31: "the physical parameter can be a differential, such as a differential air pressure, a differential laser energy, a differential vacuum pressure or other suitable differentials.") Thus, the claim language is clear and supported by the specification.
Claim 28 recites steps of monitoring, generating, receiving, determining, and modifying, with the control system as the actor (spec. at p. 31: "the algorithm proceeds to 810. At 810, it is determined whether any physical parameters are greater than or otherwise exceed a threshold..."). The "differential" is the difference between the first and second parameter data (spec. at p. 31: "the physical parameter can be a differential, such as a differential air pressure, a differential laser energy, a differential vacuum pressure..."). The antecedent basis for "the differential" is provided by the prior step of "determining whether a differential of the first parameter data and the second parameter data exceeds a predetermined value.”
Each claim is supported by clear disclosure in the specification, with explicit references to the relevant passages. The amendments to claims 20—22 address the minor informalities identified by the Examiner. The "differential" limitations are clearly defined and supported, and the actor performing the method steps is unambiguously the control system. The antecedent basis for "the differential” is provided in the claims. The dependent claims add specificity and do not introduce indefiniteness. Therefore, the rejections under 35 U.S.C. 112(b) are not warranted for any of the claims. Withdrawal of the rejections is respectfully requested.” [see pgs. 6-7 of applicant’s arguments received on 6/5/2025]
In response these arguments are not persuasive. First, applicant’s arguments are not commensurate with the scope of the claims. While the claims are read in light of the specification, this does not mean the limitations of the specification are imported into the claims [see MPEP 2111.01… “Though understanding the claim language may be aided by explanations contained in the written description, it is important not to import into a claim limitations that are not part of the claim. For example, a particular embodiment appearing in the written description may not be read into a claim when the claim language is broader than the embodiment." Superguide Corp. v. DirecTV Enterprises, Inc., 358 F.3d 870, 875, 69 USPQ2d 1865, 1868 (Fed. Cir. 2004). See also Liebel-Flarsheim Co. v. Medrad Inc., 358 F.3d 898, 906, 69 USPQ2d 1801, 1807 (Fed. Cir. 2004)”]. During examination, claims are interpreted under the standard of broadest reasonable interpretation consistent with the specification [see MPEP 2173.01…. The first step to examining a claim to determine if the language is definite is to fully understand the subject matter of the invention disclosed in the application and to ascertain the boundaries of that subject matter encompassed by the claim. During examination, a claim must be given its broadest reasonable interpretation consistent with the specification as it would be interpreted by one of ordinary skill in the art. Because the applicant has the opportunity to amend claims during prosecution, giving a claim its broadest reasonable interpretation will reduce the possibility that the claim, once issued, will be interpreted more broadly than is justified. In re Yamamoto, 740 F.2d 1569, 1571, 222 USPQ 934, 936 (Fed. Cir. 1984); In re Zletz, 893 F.2d 319, 321, 13 USPQ2d 1320, 1322 (Fed. Cir. 1989)].
In this situation applicant points out specific examples (i.e. additional disclosed features) that are currently disclosed but not claimed. First, claim 19 recites “A safety system for laser treatment”. Claim 19 never positively recites a laser or the source or treatment head, just a safety system which may or may not include a laser. While a laser with a source and treatment head are disclosed in examples in the disclosure these are features not positively claimed and it would be improper to import these disclosed features into the claims under broadest reasonable interpretation. Similarly with claim 28, while the disclosure presents an algorithm in one example to perform steps implying a controller is controlling the step of “determining whether a differential of the first parameter data or the second parameter data exceeds a predetermined value” as claimed, no algorithm is claimed so applicant is relying on a feature disclosed but not currently claimed. Finally, while examples of differential between same parameter values measured at the head and source are disclosed, the claims fail to actually recite the disclosed narrower differential of between the first parameter data and second parameter data. Thus, each of the arguments appear to rely on features disclosed, but not currently claimed. Given that arguments rely on features disclosed in specific embodiments but are not positively claimed, the scope of the limitations are broader than applicant argues. Therefore, these arguments are not persuasive and these 112 rejections have been maintained.
Finally, with respect to the previous 112 rejection of claim 28 for the lack of antecedent basis for the limitation “the differential of the first parameter data or the second parameter data exceeds the predetermined value”, the issue has not been fully addressed.
The issue here is that claim 28 first recites:
“a differential of the first parameter data and the second parameter data exceeds a predetermined value”
But then later the scope of the differential changes to
“the differential of the first parameter data or the second parameter data exceeds the predetermined value.”
This is because the term “and” and the term “or” have different scopes. The language has not been amended in the most recent amendment. And, neither the arguments, nor the cited section actually address why even in spite of the change in scope, the two refer to the same differential. As mentioned previously this was interpreted as a mistaken typo because this issue doesn’t appear to exist in independent claim 19 (which seems to be supported in applicant’s arguments). However, since the language hasn’t been amended and this mismatch between the change in scope has not been persuasively addressed in the arguments, the rejection for this antecedent basis has been maintained as well.
Applicant's arguments, see pgs. 7-9 filed 6/5/2025 with respect to the previous rejections of:
claims 19 and 28 under 35 USC 103 as being unpatentable over Knowlton in view of Cannon
claims 20-21 and 29-30 under 35 USC 103 as being unpatentable over Knowlton in view of Cannon in view of Hendrick
claims 22, 24-25, 31 and 33-34 as being unpatentable over Knowlton in view of Cannon in view of Croll
claims 23 and 32 under 35 USC 103 as being unpatentable over Knowlton in view of Cannon in view of Croll in view of Daly
claims 26-27 and 35-36 under 35 USC 103 as being unpatentable over Knowlton in view of Cannon in view of Zemmouri
have been fully considered but they are not persuasive.
The crux of the arguments appears to be directed to independent claim 19 and 28 with claim 19 used as the specific example for both claims. Applicant appears to argue that the limitations “a control system configured to receive the first parameter data and the second parameter data and to determine whether a differential of the first parameter data and the second parameter data exceed a predetermined value” or “the control system further configured to modify an operational parameter of the source in response to a determination that the differential of the first parameter data and the second parameter data exceed the predetermined value” are not taught by Knowlton in view of Cannon because these references fails to disclose a comparison between the two separated sensor readings. In other words, the basis for the arguments appears to rest on the interpretation that a differential of the first parameter data and the second parameter data is requiring a difference between the first and second parameter data.
As applicant argues:
“the prior art fails to provide a prima facie basis for the rejections because it fails to disclose each element of the claimed inventions. Consider claim 19, which includes a safety system for laser treatment, comprising a first sensor configured to monitor a parameter at a source and to generate first parameter data, a second sensor configured to monitor the parameter at a treatment head and to generate second parameter data, a control system configured to receive the first parameter data and the second parameter data and to determine whether a differential of the first parameter data and the second parameter data exceeds a predetermined value and the control system further configured to modify an operational parameter of the source in response to a determination that the differential of the first parameter data and the second parameter data exceeds the predetermined value. Knowlton discloses systems where sensors monitor individual parameters such as temperature or impedance at the treatment site (e.g., at or near the treatment head), and the control system adjusts energy delivery based on these measurements. However, Knowlton does not disclose or suggest a system where a first sensor at the source and a second sensor at the treatment head are both used, nor does it teach comparing a differential between these two sets of data to a threshold as a basis for control actions, see e.g. [0125], [0173]. Likewise, Cannon describes a feedback loop where a photodetector (sensor) at the source monitors laser power, and the system adjusts the pump current to maintain the desired output. This is a single-point feedback system—there is no second sensor at the treatment head, nor is there any comparison between two spatially separated sensor readings, see e.g. [0033]- [0034], [0011], [0017]). As such, neither reference discloses the claim limitations, and the Office does not articulate a rational underpinning for the legal conclusion of obviousness, as required by KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007) (‘rejections on obviousness cannot be sustained by mere conclusory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.” (quoting In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006)). Instead of an articulated reasoning, the Office only provides the conclusory statement at page 14 that it would be obvious to combine Knowlton and Cannon “for the purpose of protecting a user from potential laser spikes during laser surgery.” In view of the fact that extensive modifications would be required to reach the claimed inventions, this conclusory statement fails to meet the standards of KSR.
Neither Knowlton nor Cannon, alone or in combination, provides any teaching, suggestion, or motivation to use both a source sensor and a treatment head sensor, nor to compare their outputs as a differential for safety or control purposes. Instead, Knowlton discloses monitoring and controlling based on treatment site feedback (e.g., temperature, impedance) to avoid tissue damage, with no reference to source-side sensing or differential analysis (see e.g. [0125], [0173]), and Cannon discloses maintaining laser output stability by monitoring source-side power only, with no consideration of treatment head conditions or multi-point differential analysis (see e.g. [0033]-[0034]). The combination of these references would not naturally lead a person of ordinary skill in the art to modify those systems to create a system where the difference between a source parameter and a treatment head parameter is the basis for safety intervention. Such modifications are not required “for the purpose of protecting a user from potential laser spikes during laser surgery,” and Cannon discloses that functionality by monitoring source-side power. Neither reference suggests that monitoring source-side power alone is insufficient “for the purpose of protecting a user from potential laser spikes during laser surgery.” Implementing a system as claimed in 19 would require synchronizing and correlating data from two physically separated sensors (source and treatment head), defining and justifying the relevance of the differential between these two data points as a safety metric, addressing potential sources of error, such as signal lag, calibration drift, or environmental influences affecting one sensor but not the other, and many other design modifications. Neither Knowlton nor Cannon addresses these technical challenges, nor do they provide any rationale for why such a differential would be meaningful or beneficial in the context of laser safety systems. In addition, both Knowlton and Cannon describe control actions (e.g., reducing power, shutting down the system) based on single-sensor feedback. There is no disclosure or suggestion in either reference of modifying an operational parameter of the source in response to a determination that the differential between two sensor readings exceeds a threshold. Claim 19 is not a mere aggregation of known elements; rather, it recites a specific interaction between two sensors at different locations and a control system that acts on the difference between their outputs. This is a non-trivial arrangement that is not taught or suggested by the cited art. Similar arguments apply to the rejection of claim 28.” [see pgs. 7-9 of applicant’s arguments received on 6/5/2025]
In response these arguments are not persuasive, because they are not commensurate with the scope of the claims. As outlined above the limitation “a control system configured to receive the first parameter data and the second parameter data and to determine whether a differential of the first parameter data and the second parameter data exceeds a predetermined value” and “the control system further configured to modify an operational parameter of the source in response to a determination that the differential of the first parameter data and the second parameter data exceeds the predetermined value.” for claim 19 and the respective claims “determining whether a differential of the first parameter data and the second parameter data exceeds a predetermined value” and “modifying an operational parameter of the source using the control system in response to a determination that the differential of the first parameter data or the second parameter data exceeds the predetermined value” for claim 28 are broader under broadest reasonable interpretation than how applicant has interpreted the limitations for the reasons outlined in the response to the 112 rejection arguments. Applicant’s arguments here appear to rely on the interpretation that “determine /determining whether a differential of the first parameter data and the second parameter data exceeds a predetermined value as actually being “determine /determining whether a differential of the first parameter data between the second parameter data exceeds a predetermined value”. As applicant’s arguments are based on this interpretation which is narrower than what is claimed under broadest reasonable interpretation for the reasons discussed above, the basis of these arguments are not commensurate in scope with the prior art rejections. Therefore, applicant’s arguments are not persuasive.
It should be noted that if applicant claimed the differential as being the difference between the first and second parameter data as argued this would overcome the current prior art rejection for claims 19 and 28.
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 19-34 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.
Regarding claims 19-27:
First, claim 19 is “a safety system for laser treatment” that recites:
“a first sensor configured to monitor a parameter at a source and to generate first parameter data”
“a second sensor configured to monitor the parameter at a treatment head and to generate second parameter data”.
These limitations are indefinite because it is not clear what the scopes of “configured to monitor a parameter at a source” and “configured to monitor the parameter at a treatment head” are. The limitations positively recite a first and second sensors and claim that the first sensor is configured to monitor a parameter at a source and the second sensor is configured to monitor parameter at a treatment head. Yet, the recited source and the recited treatment head are never positively claimed. However, the first and second sensors are specifically claimed as being configured to monitor parameters at these structures which implies some type of required contact between the sensors at these structures. If these structures are not required, how can these sensors be in configured to monitor as claimed? This raises the questions are the “source” and “treatment head” being claimed or not? And if these structures are not required, what are the metes and boundaries for “configured to monitor a parameter at a source and to generate first parameter data” and a second sensor being “configured to monitor the parameter as claimed? For this examination, the interpretation taken for these limitations is that the source and treatment head are required and that the sensors must be configured to have some type of contact at these locations as claimed; however, regardless if this is the intended interpretation or not the claims need to be clarified.
Second, the limitation “determine whether a differential of the first parameter data and the second parameter data exceeds a predetermined value” can be interpreted in three different ways.
The first interpretation is that the differential of the first parameter data and the second parameter data is claiming taking a difference (i.e. a differential) specifically between the first parameter data and the second parameter data and that the resulting difference is compared to predetermined value.
The second interpretation is that the limitation is reciting taking a difference (i.e. differential) between first parameter data and something else independent of the second parameter data and also taking a difference (i.e. differential) between second parameter data and something else independent of the first parameter data and comparing to see if the difference in either of these differentials is greater than the predetermined value.
The third interpretation is that the claim is reciting a condition of both a difference (i.e. differential) between the first parameter data and something else independent of the second parameter data and also the second parameter data itself and comparing to see if both exceed the predetermined value.
Dependent claims 20-22 appear to further define the first parameter data as being a specific type of differential with no further definition of the second parameter data, which implies the first parameter differential and second parameter differential are two separate differentials that can be independent of each other. Based on these features, the second interpretation appears to be the intended interpretation and has been taken for this examination. Regardless if this applicant’s intention, this limitation needs to be clarified. Also, please make sure any amendments are accounted for in the dependent claims.
Regarding claims 28-34:
First, claim 28 recites a method for laser treatment that includes step of:
“determining whether a differential of the first parameter data or the second parameter data exceeds a predetermined value”
It’s not clear what is performing this step. Is it an individual, a control system, or either the individual or controller? The step previous to this step recites the following: “receive the first parameter and second parameter data at a control system”.
Additionally, para 3 of applicant’s written specification received on 3/18/2024 recites the following:
“A control system receives the first parameter data and the second parameter data and determines whether the first parameter data or the second parameter data exceed a predetermined value. The control system modifies an operational parameter of the source in response to a determination that the first parameter data or the second parameter data exceed the predetermined value, such as to increase or decrease laser energy, air pressure or vacuum.”
Based on both, it appears applicant’s intention is that the control system performs this step. Thus, the most reasonable interpretation and the interpretation taken for this examination is that the control system performs this step. Regardless if this applicant’s intention, this limitation needs to be clarified.
Second, the limitation:
“determining whether a differential of the first parameter data and the second parameter data exceeds a predetermined value” in claim 28 can be interpreted in three different ways.
The first interpretation is that the differential of the first parameter data and the second parameter data is claiming taking a difference (i.e. a differential) specifically between the first parameter data and the second parameter data and that the resulting difference is compared to predetermined value.
The second interpretation is that the claim is reciting taking a difference (i.e. differential) between first parameter data and something else independent of the second parameter data and taking a difference (i.e. differential) between second parameter data and something else independent of the first parameter data and comparing to see if the difference in either of these differentials is greater than the predetermined value.
The third interpretation is that the claim is reciting a condition of both a difference (i.e. differential) between the first parameter data and something else independent of the second parameter data and also the second parameter data itself and comparing to see if both exceed the predetermined value.
The second interpretation is the interpretation taken for this examination. Regardless if this applicant’s intention, this limitation and any language related to this limitation (including in dependent claims) needs to be amended to make clear what exactly is being claimed here.
Third, claim 28 recites the limitation " the differential" in the limitation “modifying an operational parameter of the source using the control system in response to a determination that the differential of the first parameter data or the second parameter data exceeds the predetermined value”. There is insufficient antecedent basis for this limitation in the claim.
Previous to this limitation, claim 28 recites “determining whether a differential of the first parameter data and the second parameter data exceeds a predetermined value”.
Given that context, it is not clear if the “or” is a typo and applicant meant to include “and” instead. Based on this context and how the other independent claim (claim 19) is written, this limitation is interpreted as having a typo and the limitation “modifying an operational parameter of the source using the control system in response to a determination that the differential of the first parameter data or the second parameter data exceeds the predetermined value” has been interpreted as if written as “modifying an operational parameter of the source using the control system in response to a determination that the differential of the first parameter data and the second parameter data exceeds the predetermined value”.
Regardless if applicant’s intention or not applicant needs to amend the claims to make it clear what applicant meant to claim here.
Dependent claims 20-27 and 29-34 are rejected as well under 35 USC 112(b) based on dependency to either claim 19 or claim 28. Also, please check the dependent claims to account for consistency in any amendment made.
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 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(s) 19 and 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Knowlton et al (US 20040206365) hereafter known as Knowlton in view of Cannon et al (US 20200251873) hereafter known as Cannon.
Independent claims:
Regarding claim 19:
Knowlton discloses:
A safety system for laser treatment [see Figs. 1 and 2A-2B and para 204… “For laser embodiments, patient feedback can be utilized to achieve skin rejuvenation while preserving, at least in part, the epidermal layer and/or prevent burning, photocoagulation, or other injury to the epidermal layer or other non-target tissue.”], comprising:
a source [see para 204… “Suitable lasers can include, but are not limited to, any medical laser known in the arts including CO2 lasers, YAG lasers, dermatological lasers, flash lamp, pumped pulsed dye laser (585 nm), argon-pumped tunable dye laser (577 nm, 585 nm), copper vapor or copper bromide laser (578 nm).”]
a second sensor configured to monitor the parameter at a treatment head and to generate second parameter data [see Figs. 2A-2B element 23 which is a second sensor and elements 18 and 20 are to a treatment head and para 125… “A sensor 23 is positioned at or adjacent energy delivery surface 20 and/or electrode 18 to monitor temperature, impedance (electrical), Temperature measurements is second parameter data];
a control system configured to receive the second parameter data and to determine whether a differential of a second parameter data exceed a predetermined value [see Fig. 2B and Fig. 23 element 54 and para 167… “a control system 54” and para 113… “Inputs parameters to the feedback control system 54 can include, but are not limited to temperature, impedance, pain or thermal sensation and biometric indications thereof, skin conductivity, skin color, and pressure of the tissue interface 21, energy delivery device 18 (including surface 18') and underlying structure, separately or in combination.” and para 176… “A control signal is generated by controller 404 that is proportional to the difference between an actual measured temperature and a desired temperature. The control signal is used by power circuits 406 to adjust the power output an appropriate amount in order to maintain the desired temperature delivered at the sensor 346.” As described here, differences of temperature (i.e. a differential of the first parameter data) are compared to set thresholds of temperature (i.e. a predetermined value)]; and
the control system further configured to modify an operational parameter of the source in response to a determination that the second parameter data exceed the predetermined value [see para 125 “Sensor 23 is used to control the delivery of energy and reduce the risk of cell necrosis at the surface of the skin as well and/or damage to underlying soft tissue structures.” And para 207… “reduce or stop treatment or energy delivery so as to maintain temperature of non-target tissue below an injury threshold level. In various embodiments, such injury threshold temperature can be 45.degree. C. or lower, 42.5.degree. C. or lower, 40.degree. C. or lower or 37.degree. C. or lower, or 35.degree. C.” and para 176… “A control signal is generated by controller 404 that is proportional to the difference between an actual measured temperature and a desired temperature. The control signal is used by power circuits 406 to adjust the power output an appropriate amount in order to maintain the desired temperature delivered at the sensor 346.” This demonstrates at least the second parameter data modifies the source. Specifically, based on difference between the measured temperature and desired temperature (i.e. a differential of the second parameter) relative to a temperature threshold (i.e. part of a predetermined value)]
However, Knowlton fails to disclose “a first sensor configured to monitor a parameter at a source and to generate first parameter data” and “the control system configured to receive the first parameter data”. Additionally, Knowlton fails to disclose the control system as determining whether a differential of the first parameter data exceeds a predetermined value, or the control system further configured to modify an operational parameter of the source in response to a determination that the differential of the first parameter data exceeds the predetermined value”. Thus, Knowlton fails to fully disclose the limitations “a control system configured to receive the first parameter data and the second parameter data and to determine whether a differential of the first parameter data and the second parameter data exceed a predetermined value” or “the control system further configured to modify an operational parameter of the source in response to a determination that the differential of the first parameter data and the second parameter data exceed the predetermined value” as claimed.
Cannon discloses in the analogous art of laser surgery [see para 10… “one aspect of the present invention to provide a simpler control system for a medical green laser which is configured to deliver laser pulses in the microseconds scale.”] a photodiode (i.e. a first sensor) [see Fig. 9 element 960 and para 33… “photodetector module 960”] positioned and configured to provide the actual power of the laser (i.e. “monitor a parameter at a source and generate first parameter data” Laser power is first parameter data; Please note: a parameter is claimed using open language and is not limited to a single or individual parameter. Thus, a parameter is interpreted as being temperature and power with a first parameter data being to power of a laser at the laser source and, as outlined above in the rejection to this claim, second parameter data is to temperature at a treatment head) which is then sent to a control system and the difference between actual power level and the selected power level is measured (i.e. a differential of the first parameter data) if the actual power level is greater the selected power level (i.e. the differential is greater than 0 (i.e. a predetermined value) it exceeds predetermined value, Please note: a predetermined value is claimed using open language and is not limited to a single or individual value. Thus, a predetermined value is interpreted as being to a set to values related to temperature and set power level) it adjusts the power (i.e. modify an operational parameter of the source) [see Fig. 9 showing arrow labeled from laser (element 950) to the photodetector module (element 960) and arrow labeled from photodetector module to FPGA (element 930) and para 34… “A feedback signal is delivered from photodiode module 960 to FPGA 930. FPGA module 930 reads such feedback signal once every 1 microsecond to compare measured power to the power selected by a user. If the power level read by FPGA 930 is higher than the power level selected by the user, FPGA 930 decreases the current level to pumping diode 940. If the power level read by FPGA 930 is lower than the power level selected by the user, FPGA 930 increases the current level to pumping diode 940.” ] to provide safety protection for high power light spikes [see para 8… “A hardware control loop, which is based on the fast photodetector, is designed to provide spike safety protection against high power light spikes”].
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Knowlton by including a photodetector module that is configured to detect the power level and direct the information about the power level to Knowlton’s controller and to configure Knowlton’s controller to compare the measured power level to the selected power level and adjust the power level based on this comparison similarly to that of Cannon for the purpose of protecting a user from potential laser spikes during laser surgery.
Regarding claim 28:
Knowlton discloses:
A method for laser treatment [see abstract… “An embodiment of the invention provides a method for treating a target tissue site comprising delivering energy to the tissue site using an energy delivery device” and para 101… “apparatus can include one or more dermatological lasers”], comprising:
monitoring the parameter at a treatment head using a second sensor [see Figs. 2A-2B element 23 which is a second sensor and elements 18 and 20 are to a treatment head and para 125… “A sensor 23 is positioned at or adjacent energy delivery surface 20 and/or electrode 18 to monitor temperature, impedance (electrical)”];
generating second parameter data as a function of the parameter measured by the second sensor [see Fig. 2B element 23 and para 125… “A sensor 23 is positioned at or adjacent energy delivery surface 20 and/or electrode 18 to monitor temperature, impedance (electrical), cooling media fluid flow and the like of tissue 9 of one or more of the following: tissue interface 21, tissue 11, or electrode 18.” Temperature measurement is a second parameter data generated by the second sensor.];
receive the second parameter data at a control system [see Fig. 2B element and para 167… “a control system 54” and para 113… “Inputs parameters to the feedback control system 54 can include, but are not limited to temperature, impedance, pain or thermal sensation and biometric indications thereof, skin conductivity, skin color, and pressure of the tissue interface 21, energy delivery device 18 (including surface 18') and underlying structure, separately or in combination.”]
determining whether a differential of the second parameter data exceeds a predetermined value [see Fig. 2B and Fig. 23 element 54 and para 113… “Inputs parameters to the feedback control system 54 can include, but are not limited to temperature, impedance, pain or thermal sensation and biometric indications thereof, skin conductivity, skin color, and pressure of the tissue interface 21, energy delivery device 18 (including surface 18') and underlying structure, separately or in combination.” and para 176… “A control signal is generated by controller 404 that is proportional to the difference between an actual measured temperature and a desired temperature. The control signal is used by power circuits 406 to adjust the power output an appropriate amount in order to maintain the desired temperature delivered at the sensor 346.” As described here, differences of temperature (i.e. a differential of the first parameter data) are compared to set thresholds of temperature (i.e. a predetermined value)]; and
modifying an operational parameter of the source using the control system in response to a determination the second parameter data exceed the predetermined value [see para 125… “Sensor 23 is used to control the delivery of energy and reduce the risk of cell necrosis at the surface of the skin as well and/or damage to underlying soft tissue structures.” And para 207… “reduce or stop treatment or energy delivery so as to maintain temperature of non-target tissue below an injury threshold level. In various embodiments, such injury threshold temperature can be 45.degree. C. or lower, 42.5.degree. C. or lower, 40.degree. C. or lower or 37.degree. C. or lower, or 35.degree. C.” and para 176… “A control signal is generated by controller 404 that is proportional to the difference between an actual measured temperature and a desired temperature. The control signal is used by power circuits 406 to adjust the power output an appropriate amount in order to maintain the desired temperature delivered at the sensor 346.” This demonstrates at least the second parameter data modifies the source. Specifically, based on difference between the measured temperature and desired temperature (i.e. a differential of the second parameter) relative to a temperature threshold (i.e. part of a predetermined value)].
However, Knowlton fails to disclose: “monitoring a parameter at a source using a first sensor” or “generating first parameter data as a function of the parameter measured by the first sensor”. Additionally, Knowlton fails to disclose determining whether a differential of the first parameter data exceeds a predetermined value and modifying an operational parameter of the source using the control system in response to a determination that the differential of the first parameter data exceeds the predetermined value. Thus, Knowlton fails to fully disclose:
“determining whether a differential of the first parameter data and the second parameter data exceeds a predetermined value” and “modifying an operational parameter of the source using the control system in response to the determination that the differential of the first parameter data or the second parameter data exceeds the predetermined value”.
Cannon discloses in the analogous art of laser surgery [see para 10… “one aspect of the present invention to provide a simpler control system for a medical green laser which is configured to deliver laser pulses in the microseconds scale.”] a photodiode (i.e. a first sensor) [see Fig. 9 element 960 and para 33… “photodetector module 960”] positioned and configured to provide the actual power of the laser (i.e. “monitor a parameter at a source and generate first parameter data” Laser power is first parameter data; Please note: a parameter is claimed using open language and is not limited to a single or individual parameter. Thus, a parameter is interpreted as being temperature and power with a first parameter data being to power of a laser at the laser source and, as outlined above in the rejection to this claim, second parameter data is to temperature at a treatment head) which is then sent to a control system and if the actual power level is greater than the selected power level (i.e. the differential is greater than 0 (i.e. a predetermined value), it exceeds predetermined value. Please note: a predetermined value is claimed using open language and is not limited to a single or individual value. Thus, a predetermined value is interpreted as being to a set temperature and set power level) adjusts the power (i.e. modify an operational parameter of the source) [see Fig. 9 showing arrow labeled from laser (element 950) to the photodetector module (element 960) and arrow labeled from photodetector module to FPGA (element 930) and para 34… “A feedback signal is delivered from photodiode module 960 to FPGA 930. FPGA module 930 reads such feedback signal once every 1 microsecond to compare measured power to the power selected by a user. If the power level read by FPGA 930 is higher than the power level selected by the user, FPGA 930 decreases the current level to pumping diode 940. If the power level read by FPGA 930 is lower than the power level selected by the user, FPGA 930 increases the current level to pumping diode 940.”] to provide safety protection for high power light spikes [see para 8… “A hardware control loop, which is based on the fast photodetector, is designed to provide spike safety protection against high power light spikes”].
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Knowlton by including a photodetector module that is configured to detect the power level and direct the information about the power level to Knowlton’s controller and to configure Knowlton’s controller to compare the measured power level to the selected power level and adjust the power level based on this comparison similarly to that of Cannon for the purpose of protecting a user from potential laser spikes during laser surgery.
Claim(s) 20-21 and 29-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Knowlton in view of Cannon as applied to claims 19 and 28 above, and further in view of Hendrick et al (US 20140276683) hereafter known as Hendrick.
Knowlton in view of Cannon discloses the invention substantially as claimed including all the limitations of claims 19 and 28 as outlined above. Additionally, Knowlton in view of Cannon discloses a system that includes a configuration that applies positive pressure (i.e. air pressure) and negative pressure (i.e. vacuum pressure) [see Fig. 2B and para 116… “Mechanical force application surface 14 can be configured to apply pressure, suction, adhesive forces and the like in order to create an extension or compression of the soft tissue structure and/or the skin surface.”]
However, Knowlton in view of Cannon fails to disclose “wherein the first parameter data is an air pressure differential” as recited by claim 20, “wherein the first parameter data is air pressure data” as recite by claim 29, “wherein the first parameter is a vacuum pressure differential data” as recited by claim 21, or “wherein the first parameter is vacuum pressure data” as recited by claim 30.
Hendrick discloses including flow sensors and pressure sensors (i.e. sensors that detect air pressure and vacuum pressure) that adjust parameters of the system [see para 109… “The filter 24, vacuum pump 18, flow sensor(s) (not shown) and/or pressure sensor(s) (not shown) may output signals that are transmitted to the CPU controlling the pulse width modulator 20. The computer-readable medium may include an algorithm, which receives the output signals and instructs the CPU how to adjusts the parameters at which the solenoid valve opens and closes.”] and that the sensors collect differences in pressures (i.e. air pressure differential data and vacuum pressure differential data) for the purpose of determining if there is a clog or obstruction [see para 46… “the present disclosure contemplate a vacuum system with clog detection features. Such embodiments comprise means to detect a difference in vacuum pressure, such as when a clog or obstruction is provided in a vacuum line and means to alert a user or operator of the device.”] in the analogous art of laser surgery [see abstract… “Laser cutting systems and mechanical cutting systems are provided in catheter devices, the cutting systems operable to ablate”]
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Knowlton in view of Cannon by including pressure and flow sensors in the system of Knowlton in view of Cannon that applies positive and negative pressure near the source (i.e. the first parameter data is air pressure data and the first parameter is vacuum pressure data) and to collect differential data of this positive and negative pressure (i.e. the first parameter is an air pressure differential and the first parameter is a vacuum pressure differential) similarly to that of Hendrick as this information can provide data on if the system that applies pressure is clogged or not.
Claim(s) 22, 24-25, 31, and 33-34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Knowlton in view of Cannon as applied to claims 1 and 10 above, and further in view of Croll et al (US 20220257975) hereafter known as Croll.
Regarding claims 22 and 31:
Knowlton in view of Cannon discloses the invention substantially as claimed including all the limitations of claim 19 and 28 as outlined above. However, Knowlton in view of Cannon fails to disclose “wherein the first parameter is a laser energy differential data” as recited by claim 22 or “wherein the first parameter data is laser energy data” as recited by claim 31.
Croll discloses a side port test module that includes a photodiode at the laser source [see Fig. 3 element 38 (side port test module) near element 34 (laser source) system understood to and para 90… “a side port test module 38 having a photo diode (not shown)” and “a laser assembly 34”] that measures electromagnetic radiation parameters including wavelength and intensity (i.e. laser energy) of the laser source, compares the radiation parameters to desired paramet