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 .
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: “at least one therapy mechanism” “a therapy start mechanism” “a therapy reminder mechanism” “a therapy repetition mechanism” in claim 19-38.
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 Objections
The claims are objected to because of the following informalities:
Claim 29 recites “the storage” in line 4. This should read “the stored data”.
Claim 31 recites “these data” in line 3. This should read “the determined data or the data from past cough maneuvers”.
Claim 32 recites “determined data”. This should read “the determined data”. Similarly “and/or data from past maneuvers” should read “and/or the data from past cough maneuvers”.
Claim 33 recites “these decisions”. This should read “the therapy-related decisions”. “the cloud” should read “the cloud-based system”.
Appropriate correction is required.
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 19-38 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.
The claims are replete with errors. The examiner has listed all the errors found below, however applicant's cooperation is required to review the file to ensure the claims are in proper form, including [dependency, antecedence, grammar, etc.].
Claim 19 recites “at least one control unit” and subsequently recites “the control unit”. It is unclear if applicant is referring to “the at least one control unit” or if they are referring to a subset of the at least one control unit. Similarly this is done with “at least one therapy device”, subsequently reciting “the therapy device”. This is done throughout the claims. For example claim 21 refers to “the control unit” “the user interface” and “the memory” (claim 19 recites “at least one user interface” and “at least one memory”). Claim 24 recites “the therapy device”. Claim 26 recites “the therapy device”. Claim 33 recites “the therapy device”. Claim 35 recites “the therapy device”. Claim 37 recites “the therapy device”. Claim 38 recites “the therapy device”.
Claim 21 is unclear due to multiple “and/or” statements. For example, in one iteration of the claim, the claim could read “The system of claim 19, wherein the control unit is configured to via an additional interface”. The examiner recommends rewording this claim. The examiner has attempted to reject the claim as best understood by the examiner. Further “the reminder of the therapy” “the start of the therapy” both have no antecedent basis.
Claim 22 recites “the start of the therapy”. There is a lack of antecedent basis for this claimed limitation.
Claim 27 recites “the reminder of the therapy” and “the start of the therapy”. Both lack antecedent basis.
Claim 34 as a whole is unclear. The examiner recommends rewording this claim. The examiner has attempted to reject the claim as best understood by the examiner.
Claim 35 recites “the reminder of the therapy”. There is a lack of antecedent basis for this claimed limitation.
Dependent claims inherit the rejections from the claims from which they depend.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 19-24, 26-27, 37 and 38 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cipollone et al. (US 2016/0279378 A1).
Regarding claim 19, Cipollone discloses:
A therapy system (10), wherein the system (10) comprises at least one therapy device (100, 118, 120, 114, 122, 167) for performing a therapy and at least one hose system (110 106) for a gas-conducting connection between the therapy device and a patient (figure 1; [0112]), wherein the therapy device comprises at least one source for gas (118, 120, 114, 122) for generating an overpressure [0114] [0116] and/or at least one drain (150 1280 figure 29) for gas for generating a negative pressure [0117] and at least temporarily provides an overpressure [0114]-[0116] and/or negative pressure to the hose system to perform the therapy [0117], and wherein the system furthermore comprises at least one control unit (220), at least one user interface (200), at least one memory (700), and at least one sensor (227 212 224 225 228) [0167] [0267], the control unit comprising at least one therapy mechanism (235, 239, 241, 248, 249) selected from a therapy start mechanism for starting a therapy (239, 235, 241, 248, 249), a therapy reminder mechanism for reminding of the therapy, and a therapy repetition mechanism for extending and/or repeating the therapy [0385], each of the therapy mechanisms being based on user actions, patient data, and/or therapy data [0177] [272] [0273] [0280].
Regarding claim 20, Cipollone further discloses wherein the therapy comprises one or more of a cough therapy [0220] (cough assist maneuver), a cough assistance [0025], an insufflation [0025], an insufflation with following exsufflation [0025], and an extraction of secretion from a mouth or airways [0117] [0381].
Regarding claim 21, Cipollone further discloses wherein the control unit is configured to automatically adapt a frequency of the reminder of the therapy and/or the start of the therapy via the user interface (automatically adapts the start of providing breaths as described in [0273] based on patient initiating each breath) and/or via an additional interface and/or from data characterizing a patient from the memory.
Regarding claim 22, Cipollone further discloses wherein based on determined data (patient initiating a breath as per [0273], the therapy is automatically started (breath is delivered and thus therapy is started as per [0273]), the start of the therapy is offered to a patient or a reminder of the therapy is given if the determined data indicate that a secretion removal from airways by a therapy would be expedient.
Regarding claim 23, Cipollone further discloses wherein the determined data comprise one or more of measured values and stored values for SpO2, pulse, CO2, and a changing pressure (as per [0259], 277 is used to detect breath initiation and as per [0258] 277 is from a pressure transducer signal) and/or volume flow behavior.
Regarding claim 24, Cipollone further discloses wherein the therapy device is coupled with a ventilator or the therapy device and a ventilator are combined as one device (ventilator and therapy device are combined 100, 118, 120, 114, 122, 167) and data for the at least one therapy mechanism (235, 239, 241, 248, 249) are provided by the ventilator [0177] [272] [0273] [0280].
Regarding claim 26, Cipollone further discloses wherein the therapy device and the ventilator are pneumatically coupled (therapy device is combined with ventilator into 100 as shown in figure 2), so that a ventilation (any desired type of ventilation [0370]) and a machine insufflation and exsufflation can be directly combined [0383].
Regarding claim 27, Cipollone further discloses wherein the reminder of the therapy or the start of the therapy takes place exclusively or additionally via the coupled ventilator (start of therapy as per [0273]).
Regarding claim 37, Cipollone further discloses wherein the therapy device is configured to at least temporarily provide overpressure for an insufflation [0025] and/or at least temporarily provide negative pressure for extracting secretion and/or for an exsufflation to the hose system [0405].
Regarding claim 38, Cipollone further discloses wherein the at least one control unit (controller [0025]), the at least one memory (700 [0352]), the at least one user interface (user input [0025]), and the at least one sensor (227 212 224 225 228) [0167] [0267] are a part of the therapy device (figure 1 [0025] [0352] [0167] [0267]).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 25, 28-29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cipollone et al. (US 2016/0279378 A1) in view of Lotz et al. (CN 103458949 A). The examiner notes the translation of Lotz is relied upon in the rejection set forth below.
Regarding claim 25, Cipollone does not explicitly disclose wherein a determined effect of performed therapies on a profile of at least one of the variables SpO2, CO2, flow, tidal volume, signal-to-noise ratio (SNR) changes ventilation parameters on the ventilator.
However, Lotz teaches a system for respiratory therapy (abstract) wherein a determined effect of performed therapies on a profile of at least one of the variables SpO2 [0023], CO2, flow, tidal volume, signal-to-noise ratio (SNR) changes ventilation parameters on the ventilator [0028].
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Cipollone such that a determined effect of performed therapies on a profile of at least one of the variables SpO2, CO2, flow, tidal volume, signal-to-noise ratio (SNR) changes ventilation parameters on the ventilator for the benefit of taking into account a patient’s blood oxygen levels to improve patient therapy [0028].
Regarding claim 28, Cipollone discloses the claimed invention substantially as claimed as set forth for claim 19 above. Cipollone does not explicitly disclose wherein data on which the at least one therapy mechanism is based comprise an SpO2 value, at least one of the following functions being executed when the SpO2 value reaches an SpO2 threshold value: reminder of the therapy, start of the therapy, repetition of the therapy, extension of the therapy.
However, Lotz teaches a system for respiratory therapy (abstract) wherein data on which the at least one therapy mechanism is based comprise an SpO2 value (SpO2 level as per [0023]), at least one of the following functions being executed when the SpO2 value reaches an SpO2 threshold value (SpO2 level threshold level): reminder of the therapy, start of the therapy, repetition of the therapy (higher than SpO2 threshold level may trigger the same… [0023]), extension of the therapy (higher than SpO2 threshold level may trigger the same… [0023] which indicates the therapy is continued and thus extended).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Cipollone such that data on which the at least one therapy mechanism is based comprise an SpO2 value, at least one of the following functions being executed when the SpO2 value reaches an SpO2 threshold value: reminder of the therapy, start of the therapy, repetition of the therapy, extension of the therapy for the benefit of taking into account a patient’s blood oxygen levels to improve patient therapy [0028].
Regarding claim 29, Cipollone discloses the claimed invention substantially as claimed as set forth for claim 19 above. Cipollone does not explicitly disclose wherein an effect of a performed therapy on a profile of at least one of the following variables is stored and/or processed: SpO2, CO2, pressure, flow, tidal volume, acoustic signals, signal-to-noise ratio (SNR) in the therapy device and/or in a coupled ventilator, the storage and/or processed data being taken into consideration in decisions on at least one of the following functions: start of the therapy, repetition of the therapy, reminder of the therapy.
However, Lotz teaches a system for respiratory therapy (abstract) wherein an effect of a performed therapy on a profile of at least one of the following variables is stored and/or processed: SpO2 [0023], CO2, pressure, flow, tidal volume, acoustic signals, signal-to-noise ratio (SNR) in the therapy device and/or in a coupled ventilator, the storage and/or processed data being taken into consideration in decisions on at least one of the following functions: start of the therapy [0029], repetition of the therapy ([0023] [0028]), reminder of the therapy.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Cipollone such that an effect of a performed therapy on a profile of at least one of the following variables is stored and/or processed: SpO2, CO2, pressure, flow, tidal volume, acoustic signals, signal-to-noise ratio (SNR) in the therapy device and/or in a coupled ventilator, the storage and/or processed data being taken into consideration in decisions on at least one of the following functions: start of the therapy, repetition of the therapy, reminder of the therapy for the benefit of taking into account a patient’s blood oxygen levels to improve patient therapy [0028].
Claim(s) 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cipollone et al. (US 2016/0279378 A1) in view of Farhad (US 2016/0045694 A1).
Regarding claim 30, Cipollone discloses the claimed invention substantially as claimed as set forth for claim 19 above. Cipollone does not explicitly disclose
wherein the system is configured to evaluate a signal-to-noise ratio (SNR) of pressure and/or flow signals and to initiate or extend a start of the therapy or a reminder of the therapy if the SNR value reaches an SNR threshold value.
However Farhad teaches wherein the system is configured to evaluate a signal-to-noise ratio (SNR) of pressure and/or flow signals (sensors are pressure and flow [0055] [0057] and derivatives are derived based on sensor measurements [0004]-[0005]; [0075] discusses SNR) and the ratio is the and to initiate or extend a start of the therapy or a reminder of the therapy if the SNR value reaches an SNR threshold value ([0075] therapy with small trigger/large level is initiated).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Cipollone such that the system is configured to evaluate a signal-to-noise ratio (SNR) of pressure and/or flow signals and to initiate or extend a start of the therapy or a reminder of the therapy if the SNR value reaches an SNR threshold value for the benefit of selecting the correct trigger for inspiration [0002] [0075].
Claim(s) 31-32, 34-36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cipollone et al. (US 2016/0279378 A1) in view of Tiemann et al. (EP 3,501,583 A1). The examiner notes that the translation is relied upon in the rejection set forth below.
Regarding claim 31, Cipollone discloses the claimed invention substantially as claimed as set forth for claim 19 above. Cipollone does not explicitly disclose
wherein, based on determined data or based on data from past cough maneuvers, repetitions of insufflations and exsufflations are performed automatically and/or offered to a patient if these data indicate that further secretion should be removed from the airways.
However, Tiemann teaches wherein, based on determined data (SpO2: last paragraph of page 12-first paragraph of page 13) or based on data from past cough maneuvers, repetitions of insufflations and exsufflations are performed automatically (first paragraph of page 13) and/or offered to a patient if these data indicate that further secretion should be removed from the airways (last paragraph of page 13).
Therefore, it would have been obvious to have modified Cipollone such that based on determined data or based on data from past cough maneuvers, repetitions of insufflations and exsufflations are performed automatically and/or offered to a patient if these data indicate that further secretion should be removed from the airways in order to ensure the patient’s SpO2 levels are in an appropriate range and clear secretions to fix low SpO2 levels (page 12 last paragraph - page 13 first paragraph).
Regarding claim 32, Cipollone as modified further discloses wherein determined data comprise one or more of measured values and stored values on one or more of pressure, flow, tidal volume, SpO2 (Tiemann: last paragraph of page 12-first paragraph of page 13), pulse, CO2, and/or data from past maneuvers comprise a cough flow.
Regarding claim 34, Cipollone discloses the claimed invention substantially as claimed as set forth for claim 19 above. Cipollone does not explicitly disclose
wherein a user-side feedback on a subjective perception of automatically performed starting procedures of the therapy and/or repetitions of the therapy and/or reminders of the therapy at the user interface and/or via an app on a mobile terminal coupled with the therapy device is possible, the user-side feedback being stored and/or processed and being taken into consideration in following decisions on the start of the therapy and/or the repetition of the therapy and/or the reminder of starting the therapy.
However, Tiemann teaches (as best understood by the examiner: see 112b above) a user-side feedback on a subjective perception of automatically performed starting procedures of the therapy and/or repetitions of the therapy and/or reminders of the therapy at the user interface and/or via an app on a mobile terminal coupled with the therapy device is possible, the user-side feedback being stored and/or processed and being taken into consideration in following decisions on the start of the therapy and/or the repetition of the therapy and/or the reminder of starting the therapy. (see paragraphs 1-2 of page 9 which discusses user input).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Cipollone such that a user-side feedback on a subjective perception of automatically performed starting procedures of the therapy and/or repetitions of the therapy and/or reminders of the therapy at the user interface and/or via an app on a mobile terminal coupled with the therapy device is possible, the user-side feedback being stored and/or processed and being taken into consideration in following decisions on the start of the therapy and/or the repetition of the therapy and/or the reminder of starting the therapy for the benefit of allowing a user to have input in their therapy (page 9, paragraphs 1-2).
Regarding claim 35, Cipollone discloses the claimed invention substantially as claimed as set forth for claim 19 above. Cipollone does not explicitly disclose
wherein a cough therapy as a result of the reminder of the therapy can be started and/or repeated and/or ended by the therapy device on a user side via a remote control and/or an app on a mobile terminal coupled with the therapy device.
However Tiemann teaches wherein a cough therapy as a result of the reminder of the therapy (page 13, last paragraph) can be started and/or repeated and/or ended by the therapy device on a user side via a remote control (page 13, paragraph 9) and/or an app on a mobile terminal coupled with the therapy device.
Therefore, it would be obvious to have modified Cipollone wherein a cough therapy as a result of the reminder of the therapy can be started and/or repeated and/or ended by the therapy device on a user side via a remote control and/or an app on a mobile terminal coupled with the therapy device in order to allow a patient to trigger a cough therapy when the system detects a possible worsening. This ensures patient safety and allows them to have control over their own therapy.
Regarding claim 36, Cipollone discloses the claimed invention substantially as claimed as set forth for claim 19 above. Cipollone does not explicitly disclose
wherein an automatic start of the therapy is provided on the basis of determined data, therapy parameters being automatically adapted on the basis of the determined data.
However, Tiemann teaches wherein an automatic start of the therapy is provided on the basis of determined data (SpO2: page 13, first paragraph), therapy parameters being automatically adapted on the basis of the determined data. (page 12, last paragraph - page 13, first paragraph).
Therefore, it would have been obvious to one having ordinary skill in the art to have modified Cipolle wherein an automatic start of the therapy is provided on the basis of determined data, therapy parameters being automatically adapted on the basis of the determined data for the benefit of ensuring SpO2 levels do not get too low and that they are fixed with a cough therapy. This ensures patient safety.
Claim(s) 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cipollone et al. (US 2016/0279378 A1) in view of Anderson (WO 2017/062742 A1).
Regarding claim 33, Cipollone discloses the claimed invention substantially as claimed as set forth for claim 19 above. Cipollone does not explicitly disclose
wherein determined and/or stored data are uploaded in a cloud-based system, cloud-based algorithms make therapy-related decisions, and these decisions are in turn provided to the therapy device from the cloud for adaptation of the therapy or of starting points in time of the therapy.
However, Anderson teaches wherein determined and/or stored data are uploaded in a cloud-based system [0052], cloud-based algorithms make therapy-related decisions [0052], and these decisions are in turn provided to the therapy device from the remote device for adaptation of the therapy or of starting points in time of the therapy [0052].
Therefore, it would have been obvious to have modified Cipollone wherein determined and/or stored data are uploaded in a cloud-based system, cloud-based algorithms make therapy-related decisions, and these decisions are in turn provided to the therapy device from the cloud for adaptation of the therapy or of starting points in time of the therapy as taught by Anderson as this is a well known way of controlling a therapeutic device.
Conclusion
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/VICTORIA MURPHY/Primary Patent Examiner, Art Unit 3785