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.
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: “rotatable component” and “varying component” in claim 1, “pulsatile component” in claim 5 and “directionally varying component” in claim 6.
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.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 2-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 10-21 of U.S. Patent No. 12,128,004 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are co-extensive in scope despite a slight difference in wording.
Regarding claim 2, Patent 12,128,004 B2 discloses a method of treating fluid stasis, the method comprising:
operating a fluid stasis treatment system to output an airstream from an airstream nozzle onto a skin of a patient to shear-thin static fluid, condition one or more natural drainage regions for uptake of static fluid, and/or move static fluid toward one or more natural drainage regions for static fluid, wherein an airflow used to generate the airstream induces rotation of a rotatable component of the airstream nozzle about a rotational axis that is aligned with the airflow, and wherein the airstream comprises a varying component (Claim 13).
Regarding claim 3, Patent 12,128,004 B2 discloses the method of claim 2.
Patent 12,128,004 B2 further discloses moving the airstream nozzle toward the one or more natural drainage regions for static fluid one or more times (Claim 14).
Regarding claim 4, Patent 12,128,004 B2 discloses the method of claim 2.
Patent 12,128,004 B2 further discloses wherein outputting the airstream comprises orienting the airstream nozzle so that an angle between a direction of the airstream leaving the airstream nozzle and the skin is in a range from 0 degrees to 60 degrees (Claim 15).
Regarding claim 5, Patent 12,128,004 B2 discloses the method of claim 2.
Patent 12,128,004 B2 further discloses wherein the airstream comprises a pulsatile component (Claim 16).
Regarding claim 6, Patent 12,128,004 B2 discloses the method of claim 2.
Patent 12,128,004 B2 further discloses wherein the airstream comprises a directionally varying component (Claim 17).
Regarding claim 7, Patent 12,128,004 B2 discloses the method of claim 2.
Patent 12,128,004 B2 further discloses outputting a second airstream from a second airstream nozzle onto the skin to shear-thin static fluid (Claim 18).
Regarding claim 8, Patent 12,128,004 B2 discloses the method of claim 2.
Patent 12,128,004 B2 further discloses generating, by a fluid sensor, a fluid sensor output signal indicative of an extent of static fluid within a treated tissue of the patient; processing the fluid sensor output signal to determine the extent of static fluid within the treated tissue; and outputting a feedback indicative of the extent of static fluid within the treated tissue to an operator of the fluid stasis treatment system (Claim 19; The output of feedback is to be delivered to whoever is using the device and thus, an operator).
Regarding claim 9, Patent 12,128,004 B2 discloses the method of claim 8.
Patent 12,128,004 B2 further discloses wherein the fluid sensor comprises an impedance sensor (Claim 20).
Regarding claim 10, Patent 12,128,004 B2 discloses the method of claim 2.
Patent 12,128,004 B2 further discloses generating, via an image sensor, skin movement image data for a region of the skin of the patient having induced movements induced by the airstream; processing the skin movement image data to estimate an extent of static fluid within a tissue underlying the region of the skin of the patient; and outputting a feedback indicative of the extent of static fluid within the tissue underlying the region of the skin of the patient to an operator of the fluid stasis treatment system (Claim 21; The output of feedback is to be delivered to whoever is using the device and thus, an operator).
Regarding claim 11, Patent 12,128,004 B2 discloses a method of treating fluid stasis, the method comprising:
operating a fluid stasis treatment system to output an airstream from an airstream nozzle outlet orifice at a flow rate onto a skin of a patient to shear-thin static fluid, condition one or more natural drainage regions for uptake of static fluid, and/or move static fluid toward one or more natural drainage regions for static fluid (Claims 10 and 12, the system provides feedback for operation and guidance of nozzle to drain fluids);
generating, by a sensor, a sensor output signal indicative of an extent of static fluid within a treated tissue of the patient (Claims 10 and 12);
processing the sensor output signal to determine the extent of static fluid within the treated tissue (Claims 10 and 12; Control unit processes the signal); and
outputting a feedback indicative of the extent of static fluid within the treated tissue to an operator of the fluid stasis treatment system (Claims 10 and 12, the operator of the device receives the feedback to direct the nozzle).
Regarding claim 12, Patent 12,128,004 B2 discloses the method of claim 11.
Patent 12,128,004 B2 further discloses wherein: the airstream nozzle outlet orifice has an airstream nozzle outlet orifice cross-sectional area; and a ratio of the flow rate to the airstream nozzle outlet orifice cross-sectional area is in a range from 0.004 (m3/min)/mm2 to 0.020 (m3/min)/mm2 (Claims 10 and 12).
Regarding claim 13, Patent 12,128,004 B2 discloses the method of claim 12.
Patent 12,128,004 B2 further discloses wherein the flow rate is at least 0.85 m3/min (Claims 10 and 12).
Regarding claim 14, Patent 12,128,004 B2 discloses the method of claim 11.
Patent 12,128,004 B2 further discloses wherein the flow rate is at least 0.85 m3/min (Claims 10 and 12).
Regarding claim 15, Patent 12,128,004 B2 discloses the method of claim 11.
Patent 12,128,004 B2 further discloses wherein the sensor comprises an impedance sensor (Claim 11).
Regarding claim 16, Patent 12,128,004 B2 discloses the method of claim 11.
Patent 12,128,004 B2 further discloses wherein: the sensor comprises an image sensor that generates skin movement image data for a region of the skin of the patient having induced movements resulting from directing the airstream onto the skin of the patient; and processing the sensor output signal comprises processing the skin movement image data to estimate an extent of static fluid within a tissue underlying the region of the skin of the patient (Claim 12).
Regarding claim 17, Patent 12,128,004 B2 discloses the method of claim 11.
Patent 12,128,004 B2 further discloses wherein the sensor comprises a photoplethysmography sensor (Claim 22).
Regarding claim 18, Patent 12,128,004 B2 discloses the method of claim 11.
Patent 12,128,004 B2 further discloses wherein the sensor comprises an ultrasound sensor (Claim 23).
Claims 11-26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 10, 13, 15-18, 20-27 of copending Application No. 19/276,536 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are co-extensive in scope despite a slight difference in wording.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding claim 11, App. 19/276,536 discloses a method of treating fluid stasis, the method comprising:
operating a fluid stasis treatment system to output an airstream from an airstream nozzle outlet orifice at a flow rate onto a skin of a patient to shear-thin static fluid, condition one or more natural drainage regions for uptake of static fluid, and/or move static fluid toward one or more natural drainage regions for static fluid (Claim 10);
generating, by a sensor, a sensor output signal indicative of an extent of static fluid within a treated tissue of the patient (Claim 10);
processing the sensor output signal to determine the extent of static fluid within the treated tissue (Claim 10); and
outputting a feedback indicative of the extent of static fluid within the treated tissue to an operator of the fluid stasis treatment system (Claim 10).
Regarding claim 12, App. 19/276,536 discloses the system of claim 11.
App. 19/276,536 further discloses wherein: the airstream nozzle outlet orifice has an airstream nozzle outlet orifice cross-sectional area; and a ratio of the flow rate to the airstream nozzle outlet orifice cross-sectional area is in a range from 0.004 (m3/min)/mm2 to 0.020 (m3/min)/mm2 (Claim 10).
Regarding claim 13, App. 19/276,536 discloses the system of claim 12.
App. 19/276,536 further discloses wherein the flow rate is at least 0.85 m3/min (Claim 13).
Regarding claim 14, App. 19/276,536 discloses the system of claim 11.
App. 19/276,536 further discloses wherein the flow rate is at least 0.85 m3/min (Claim 13).
Regarding claim 15, App. 19/276,536 discloses the system of claim 11.
App. 19/276,536 further discloses wherein the sensor comprises an impedance sensor (Claim 15).
Regarding claim 16, App. 19/276,536 discloses the system of claim 11.
App. 19/276,536 further discloses wherein: the sensor comprises an image sensor that generates skin movement image data for a region of the skin of the patient having induced movements resulting from directing the airstream onto the skin of the patient; and processing the sensor output signal comprises processing the skin movement image data to estimate an extent of static fluid within a tissue underlying the region of the skin of the patient (Claim 16).
Regarding claim 17, App. 19/276,536 discloses the system of claim 11.
App. 19/276,536 further discloses wherein the sensor comprises a photoplethysmography sensor (Claim 17).
Regarding claim 18, App. 19/276,536 discloses the system of claim 11.
App. 19/276,536 further discloses wherein the sensor comprises an ultrasound sensor (Claim 18).
Regarding claim 19, App. 19/276,536 discloses a method of treating fluid stasis, the method comprising:
operating a fluid stasis treatment system to output an airstream from an airstream nozzle outlet orifice at a flow rate onto a skin of a patient to shear-thin static fluid, condition one or more natural drainage regions for uptake of static fluid, and/or move static fluid toward one or more natural drainage regions for static fluid (Claim 20);
generating, by a sensor, a sensor output signal indicative of a proximity of the airstream nozzle outlet orifice relative to the skin of the patient or an orientation of the airstream nozzle outlet orifice (Claim 20);
processing the sensor output signal, by a control unit, to determine the proximity of the airstream nozzle outlet orifice relative to the skin of the patient or the orientation of the airstream nozzle outlet orifice (Claim 20); and
outputting a feedback indicative of the proximity of the airstream nozzle outlet orifice relative to the skin of the patient or the orientation of the airstream nozzle outlet orifice to an operator of the fluid stasis treatment system (Claim 20).
Regarding claim 20, App. 19/276,536 discloses the system of claim 19.
App. 19/276,536 further discloses wherein: the sensor comprises an accelerometer; and the feedback is indicative of the orientation of the airstream nozzle outlet orifice to the operator of the fluid stasis treatment system (Claims 20-21).
Regarding claim 21, App. 19/276,536 discloses the system of claim 19.
App. 19/276,536 further discloses wherein: the sensor comprises an ultrasonic distance sensor or a laser distance sensor; and the feedback is indicative of the proximity of the airstream nozzle outlet orifice relative to the skin of the patient to the operator of the fluid stasis treatment system (Claim 22 or 23).
Regarding claim 22, App. 19/276,536 discloses the system of claim 19.
App. 19/276,536 further discloses wherein: the sensor comprises a laser distance sensor; and the control unit is configured to control operation of an output device to output the feedback indicative of the proximity of the airstream nozzle outlet orifice relative to the skin of the patient to the operator of the fluid stasis treatment system (Claim 23).
Regarding claim 23, App. 19/276,536 discloses the system of claim 19.
App. 19/276,536 further discloses wherein: the airstream nozzle outlet orifice has an airstream nozzle outlet orifice cross-sectional area; and a ratio of the flow rate to the airstream nozzle outlet orifice cross-sectional area is in a range from 0.004 (m3/min)/mm2 to 0.020 (m3/min)/mm2 (Claim 24).
Regarding claim 24, App. 19/276,536 discloses the system of claim 23.
App. 19/276,536 further discloses wherein the flow rate is at least 0.85 m3/min (Claim 25).
Regarding claim 25, App. 19/276,536 discloses the system of claim 19.
App. 19/276,536 further discloses wherein the flow rate is at least 0.85 m3/min (Claim 26).
Regarding claim 26, App. 19/276,536 discloses the system of claim 19.
App. 19/276,536 further discloses an airflow conduit configured for transferring the airstream to the airstream nozzle outlet orifice (Claim 27).
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.
Claims 11, 14-19, 21-22, 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Courtin (U.S 3,163,161 A) in view of Palomaki (U.S 2017/0196756 A1).
Regarding claim 11, Courtin discloses a method of treating fluid stasis, the method comprising:
operating a fluid stasis treatment system to output an airstream from an airstream nozzle outlet orifice (nozzles 111/112/118, see Figs. 1-9) at a flow rate onto a skin of a patient to shear-thin static fluid (Col. 5 line 60 - Col. 6 line 20; Figs. 1-3 and 6-7; Also see Col. 3 lines 8-16, the pulsation and wave generation across the skin from the air flow causes kneading of the tissue and a draining effect of the cells, and thus moves static fluids of the cells to drain), move static fluid toward one or more natural drainage regions for static fluid (Col. 5 line 60 - Col. 6 line 20; Figs. 1-3 and 6-7; Static fluid in tissue is moved to drainage regions).
Courtin is silent regarding generating, by a sensor, a sensor output signal indicative of an extent of static fluid within a treated tissue of the patient; processing the sensor output signal to determine the extent of static fluid within the treated tissue; and outputting a feedback indicative of the extent of static fluid within the treated tissue to an operator of the fluid stasis treatment system.
However, Palomaki teaches a system for treatment of the skin and lymphedema using applied pressure to the skin (Paragraph 0002-0003) wherein a sensor is configured to generate a sensor output signal indicative of an extent of static fluid within a tissue of the patient (Paragraph 0061, 0068; A sensor may determine lymphatic fluid content and adjust the delivery of pressure accordingly); an output device (central processing unit 1, see Fig. 1 and Paragraph 0046; The output device delivers the output of pressure to the user and additionally outputs information and processes the received data); and a control unit configured to process the sensor output signal to determine the extent of static fluid within the tissue, wherein the control unit is configured to control operation of the output device to output a feedback indicative of the extent of static fluid within the tissue to an operator of the airstream nozzle (Paragraph 0061-0079, 0116; A controlling program/processing unit may determine lymphatic fluid content of the skin to adjust the applied pressure to best suit the user/treatment; Additionally see Paragraph 0079 in particular regarding use of UI such as the display 10 or audio response to provide data visualization and feedback to an operator which could include such fluid information; also see Paragraph 0027 regarding usefulness of knowledge of lymphatic system for best operation of the device).
Thus, it would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of Courtin to have included a fluid sensor to determine fluid content of the skin, and a control unit and output device to adjust pressure and provide feedback to the operator based on the fluid content of the skin, such as that taught by Palomaki, in order to adjust the pressure to best suit the condition of the skin and to provide feedback to the operator for better operation of the device (Paragraphs 0061-0079, 0116, 0027) and guide the use of the device (Paragraph 0027, 0061-0079).
Regarding claim 14, Courtin discloses the method of claim 11.
Courtin further discloses wherein the flow rate is at least 0.85 m3/min (see Col. 11 lines 59-68, the preferred delivered flow rate is between 40-80 cubic feet/min, or 1.133-2.265 cubic meters/min).
Regarding claim 15, Courtin discloses the method of claim 11.
Palomaki further teaches wherein the sensor can comprise an impedance sensor (Paragraph 0066-0067; The measurement technique used by the sensors can include bioimpedance spectroscopy, and thus an impedance sensor).
Regarding claim 16, Courtin discloses the method of claim 11.
Palomaki further teaches wherein: the sensor comprises an image sensor that generates skin movement image data for a region of the skin of the patient having induced movements resulting from directing the airstream onto the skin of the patient (Paragraph 0061, 0071; The measurement of fluid may be performed by measuring the raised bulge of the skin in response to the applied pressure and thus includes image data on how much the skin has bulged/measured distances based on imaging); and processing the sensor output signal comprises processing the skin movement image data to estimate an extent of static fluid within a tissue underlying the region of the skin of the patient (Paragraph 0061, 0071; The adjustment of the applied pressure is based on the amount of the bulge of the skin and thus includes skin movement image data); and the control unit is configured to control operation of the output device to output a feedback indicative of the extent of static fluid within the tissue to the operator of the airstream nozzle (see Paragraph 0068, 0070, 0079, 0081; Feedback may be given to the operator about adjusted parameters, such as by noise or through tactile/vibration means, the adjustment itself being based on the measurement of fluid, as pressure may be increased when there is excessive fluid; Additionally the display may show parameters such as fluid content of the skin, as this is necessary for the operator to adjust the location of treatment to mitigate lymphedema).
Regarding claim 17, Courtin discloses the method of claim 11.
Palomaki further teaches wherein the sensor comprises a photoplethysmography sensor (Paragraph 0062, 0066; Optical measurements and measurements of blood circulation may be used to adjust the operation of the device).
Regarding claim 18, Courtin discloses the method of claim 11.
Palomaki further teaches wherein the sensor comprises an ultrasound sensor (Paragraph 0066, ultrasound sensor may be used).
Regarding claim 19, Courtin discloses a method of treating fluid stasis, the method comprising:
operating a fluid stasis treatment system to output an airstream from an airstream nozzle outlet orifice (nozzles 111/112/118, see Figs. 1-9) at a flow rate onto a skin of a patient to shear-thin static fluid (Col. 5 line 60 - Col. 6 line 20; Figs. 1-3 and 6-7; Also see Col. 3 lines 8-16, the pulsation and wave generation across the skin from the air flow causes kneading of the tissue and a draining effect of the cells, and thus moves static fluids of the cells to drain; The airflow causes shear thinning to allow the static fluid to move), and move static fluid toward one or more natural drainage regions for static fluid (Col. 5 line 60 - Col. 6 line 20; Figs. 1-3 and 6-7; Static fluid in tissue is moved to drainage regions).
Courtin is silent regarding generating, by a sensor, a sensor output signal indicative of a proximity of the airstream nozzle outlet orifice relative to the skin of the patient; processing the sensor output signal, by a control unit, to determine the proximity of the airstream nozzle outlet orifice relative to the skin of the patient; and outputting a feedback indicative of the proximity of the airstream nozzle outlet orifice relative to the skin of the patient.
However, Palomaki teaches a system for treatment of the skin and lymphedema using applied pressure to the skin (Paragraph 0002-0003) wherein a sensor is configured to generate a sensor output signal indicative of a proximity of the airstream nozzle outlet orifice relative to the skin of the patient (see Paragraph 0117; The distance between the treatment head and the target skin surface can be determined and relayed to the user via visible means such as the display; The guidance element can indicate current/proper distance between the two and thus there must be a sensor to determine a current distance between the two; also see Paragraph 0063 regarding sensor in the treatment head); and a control unit configured to process the sensor output signal to determine the proximity of the airstream nozzle outlet orifice relative to the skin of the patient (Paragraph 0061-0079, 0116; A controlling program/processing unit may process and provide control signals in response to received sensor data; also see Paragraph 0117; The processing unit must process the output in order to determine the current distance in real-time), wherein the control unit is configured to control operation of the output device to output a feedback indicative of the proximity of the airstream nozzle outlet orifice relative to the skin of the patient to an operator of the airstream nozzle (Paragraph 0117; The display can provide the guidance information on the real-time distance between treatment head and skin surface; Additionally see Paragraph 0079 in particular regarding use of UI such as the display 10 or audio response to provide data visualization and feedback to an operator).
Thus, it would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of Courtin to have included a distance sensor to determine the position of the treatment head relative to the skin, and a control unit and output device to provide feedback to the operator based on the sensed distance, such as that taught by Palomaki, in order to guide the use of the device for the operator to better use the device and to provide better/efficient treatment (Paragraph 0117).
Regarding claim 21, Courtin discloses the method of claim 19.
Palomaki further teaches wherein the control unit is configured to control operation of the output device to output the feedback indicative of the proximity of the airstream nozzle outlet orifice relative to the skin of the patient to the operator of the airstream nozzle (Paragraph 0117 and rejection of Claim 20).
The modified device of Courtin is silent regarding specifically wherein the sensor is an ultrasonic distance sensor or a laser distance sensor.
However, Palomaki teaches that measurement techniques of the sensors of the device can include ultrasound/ultrasonic measurements or laser measurements (Paragraph 0066; The measurement technique can include ultrasound measurement or optical measurement of lasers).
It would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of Courtin to have included an ultrasonic distance sensor or a laser distance sensor, such as that taught by Palomaki, in order to use a known alternative of sensor measurement types (Paragraph 0066; also see Paragraph 0117).
Regarding claim 22, Courtin discloses the method of claim 19.
Palomaki further teaches wherein the control unit is configured to control operation of the output device to output the feedback indicative of the proximity of the airstream nozzle outlet orifice relative to the skin of the patient to the operator of the airstream nozzle (Paragraph 0117 and rejection of Claim 20).
The modified device of Courtin is silent regarding specifically wherein the sensor is a laser distance sensor.
However, Palomaki teaches that measurement techniques of the sensors of the device can include laser measurements (Paragraph 0066; The measurement technique can include ultrasound measurement or optical measurement of lasers).
It would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of Courtin to have included a laser distance sensor, such as that taught by Palomaki, in order to use a known alternative of sensor measurement types (Paragraph 0066; also see Paragraph 0117).
Regarding claim 25, Courtin discloses the method of claim 19.
Courtin further discloses wherein the flow rate is at least 0.85 m3/min (see Col. 11 lines 59-68, the preferred delivered flow rate is between 40-80 cubic feet/min, or 1.133-2.265 cubic meters/min).
Regarding claim 26, Courtin discloses the method of claim 19.
Courtin further discloses an airflow conduit configured for transferring the airflow to the airstream nozzle (tubes 23/16; see Fig. 13; also see Fig. 1 and tube 110 providing air to the nozzle).
Allowable Subject Matter
Claims 2-10, 12-13, 20 and 23-24 would be allowable with the filing of a Terminal Disclaimer to overcome the Non-Statutory Double Patenting Rejections as above.
The following is a statement of reasons for the indication of allowable subject matter:
The closest prior art is Courtin (U.S Patent No. 3,163,161 A) and O’Connor (WO 2001/003637 A2) and Palomaki (U.S 2017/0196756 A1) and Taskinen (U.S 9,138,370 B2) and Aghion (U.S 9,101,524 B2) and Carava (U.S 2004/0073144 A1) and Kostrov (U.S 6,706,006 B2) and Diot (FR 2667247 A1) and L’Enfant (FR 2830440 A1) and Kosecoff (U.S 2022/0088407).
Regarding claim 2, none of the prior art teaches or suggests a rotatable component of the airstream nozzle about a rotational axis that is aligned with the airflow, and wherein the airstream comprises a varying component.
The device of Courtin discloses outputting an airstream from an airstream nozzle onto the skin to condition the one or more natural drainage regions for uptake of static fluid (see Col. 6 lines 8-20 and Fig. 3 and 7, a second nozzle can deliver pressurized air to a target area to modulate the movement and oscillation of the skin, to adjust kneading and drainage of the tissues). But the device includes a motor which operates an internal disc 32 which rotates to align with a stationary disc 37, the alignment of which allows passage of air and thus introduces a pulsed air to the patient. Other embodiments disclose a rotating/varying component which interrupts or is rotated by the airflow. However, the rotation of the shaft/disc are driven by a motor, as opposed to the rotation being induced by the airflow itself, as required by the claim, or the axis of rotation of the rotating component is not in alignment with the rotating component. Thus, the structure required is substantially different from that of the instant application and would not be obvious to arbitrarily include without impermissible hindsight. None of the other prior art teach the requisite structure of the rotating component.
Regarding claims 12-13 and 23-24, none of the prior art references teach wherein the ratio of the flow rate to the airstream orifice cross-sectional area is in a range from 0.004 m3/min/mm2 to 0.020 m3/min/mm2. The O’Connor and L’Enfant references both disclose a plurality of openings through which airflow can be delivered to the body of the patient. However, the disclosed size of the openings would not generate such a claimed ratio even when in a ratio with the lowest flow rate as disclosed by Courtin. O’Connor discloses up to 5 jet openings with an upper bound of 4 mm, or a total flow area of 62.83 mm2 (Page 9 lines 6-10 and Page 10 lines 15-20 regarding between 3-5 openings in embodiments). L’enfant discloses a plurality of openings between 0.1-1mm in diameter. Thus, none of the prior art discloses a jet opening or plurality of jet openings which would place the ratio of the flow rate to the airstream orifice cross-sectional area in the claimed range.
Regarding claim 20, none of the prior art teaches or suggests displaying a feedback indicative of the orientation of the airstream nozzle to an operator. Kosecoff in particular discloses a device for delivering airflow to the patient and discloses an accelerometer for determining the orientation of the device relative to the surface of the skin. However, the device solely uses such orientation device automatically and provides no teachings of providing this information to the user via a display or any suitable visual feedback. Furthermore, it is noted that the treatment modalities and intended angles of Kosecoff and that of Courtin would be dramatically different and thus would require careful consideration of particular orientation and angles necessary to shear-thin the skin and to cause motion of the interstitial fluid to drainage areas. Kosecoff does not consider such particulars and thus the combination would only be arrived at with hindsight bias.
Conclusion
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/THOMAS W GREIG/Examiner, Art Unit 3785
/JOSEPH D. BOECKER/Primary Examiner, Art Unit 3785
