DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant's arguments filed 11/07/2025 have been fully considered but they are not persuasive. Applicant’s arguments include the following:
First, applicant argues that as Martuch, as applied to independent claim 1, does not teach that the user can change the pressure in any direction when the lock is set. The examiner finds this argument nonpersuasive as Martuch was merely combined to show that a lock can be set by a user during operation. Smith (the primary reference) as detailed in the previous rejection of claim and as admitted by the applicant (see document page 6 of the remarks), Smith allows the user to set a vacuum level and controls the vacuum accordingly, an alarm is reached after said level reaches a lock out pressure. Thus the pressure may be changed beneath the lock out pressure. Smith’s disclosure lacked the specific method step of a user inputting the lock and thus Martuch was merely brought in to show that systems with a locking system can involved a method of operation step in which a user sets the limit.
Secondly, applicant argues that the prior art combination, as applied to claim 2 and 10 (in view of Meganck) fails to teach receiving a third input from the user indicative of an attempt to adjust the suction limit above…the suction limit lock” as Meganck’s override is based on conditions of the system and not any user input. The examiner respectfully disagrees. Meganck teaches (per para. 0081 and 0082) that when the flush will exceed the system limit, a notification is displayed and an override input is made available on the user interface. Said override is selected and/or activated (per para. 0082). The examiner notes that as said notification and override are provided on a user interface and are selected and/or activated, it is interpreted that said activation is a third user input per the claimed limitation.
Applicant further argues that Wallace, as applied to that claims (assumed to be claim 8 and 9) fails to teach the limitations provided as Wallace teaches that the setting will not be automatically changed in accordance with a subsequent change in parameter. The examiner finds this argument to be nonpersuasive as Wallace was merely brought in to teach that indica, in the form of a padlock, was known in the art to be used to indicate a locking condition of the system. Therefore as Wallace teaches this, and Smith teaches a system including a lock, a prima facie case of obviousness exists based on combining prior art elements (a locking system with a lock indica to show a locked status) according to known methods to yield predictable results (that being indication of the locking condition of the system).
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.
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) 1,6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith et al. US 2016/0331876, hereafter Smith in view of Martuch US 2014/0243766, hereafter Martuch.
Regarding Claim 1, Smith discloses
A method of operating a medical waste collection system (abstract) including a waste canister (fig. 1 (112)), a vacuum source (para. 0032-0033 disclosing a vacuum source), a user interface (140), and a controller (fig. 3 controller (210))), the method comprising: receiving, at the user interface, a first input from a user indicative of a suction limit (para. 0038, where the user may set a vacuum level, alternatively the user can set an alarm threshold); controlling, with the controller (para. 0038), operation of the vacuum source such that an actual vacuum level generated by the vacuum source does not exceed the suction limit (para. 0038 where device operates via controller using selected vacuum levels that may be adjusted in real time); receiving, at the user interface, a second input from the user to activate a suction limit lock at a selected vacuum level (lock out vacuum pressure (para. 0088) aligned with an alarm threshold, where the alarm threshold is set by the user (para. 0089-0091)); permitting, with the controller, adjustment of the suction limit below the selected vacuum level, wherein the controller is configured to operate the vacuum source to adjust the actual vacuum level based on the adjustment of the suction limit (para. 0038 where the vacuum level at which the system operates can be specified in real time); and preventing, with the controller, adjustment of the suction limit above the selected vacuum level associated with the suction limit lock (lock out pressure level para. 0088, where when the lock out is initiated, the vacuum is locked and requires further input on how to operate (i.e. increase decrease suction per para. 0089)).
The examiner notes however, that the lock out value is not disclosed to be set by a user.
Martuch teaches a vacuum system and is thus considered analogous to the claimed invention. Martuch teaches that a control system for a vacuum can have a lock out feature set by a doctor or nurse to prevent patient interference (para. 0022). Therefore, as Martuch teaches that lock out levels can be set by a user (therefore having a user input), it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have a user input to set the lock out pressure for the device of Smith.
Regarding Claim 6, Martuch and Meganck teach
The method of claim 1, wherein the medical waste collection system includes memory (para. 0040) storing data indicative of a maximum suction level associated with a respective one of predetermined clinical procedures(para. 0093, where the user can select operation based on pre-programmed procedures), wherein the method further comprises: receiving, at the user interface, a selection of one of the predetermined clinical procedures (para. 0093); and automatically activating the suction limit lock and setting the selected vacuum level to be equal to the maximum suction level associated with the selected one of the predetermined clinical procedures (where the alarm threshold is set based on the selected procedure. The examiner notes that per the rejection of claim 1 (para. 0088) the alarm threshold is indicative of the suction limit lock, as once the threshold is reached the lock takes effect).
Claim(s) 2,5,10,13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith in view of Martuch and further in view of Meganck et al. US 2022/0370706, hereafter Meganck.
Regarding Claim 2, Smith and Martuch teach
The method of claim 1, but fails to teach further comprising: receiving, at the user interface, a third input from the user indicative of an attempt to adjust the suction limit above the selected vacuum level associated with the suction limit lock; and displaying, on the user interface, a prompt with an option to disable the suction limit lock in response to the third input. The examiner notes that while under the rejection of claim 1, Smith discloses support for real time adjustment of the vacuum level, where said adjustments are interpreted as inputs. The examiner notes that in combination with the lockout level being set, an input can be provided that would exceed the lockout level. Smith discloses that when the lockout is reached, the user is prompted to take another step para. 0088, where when the lock out is initiated, the vacuum is locked and requires further input on how to operate (i.e. increase decrease suction per para. 0089)). Therefore it is interpreted that an input regarding a vacuum being above the limit may be provided. However Smith does not disclose that one of the further inputs is regarding an option to disable the suction limit.
Meganck teaches a fluid management system including vacuum (para. 0050), and is thus considered analogous to the claimed invention. Meganck teaches that when a pressure limit is determined to be exceeded by an activation, an override input is made available, where the user can select the option to exceed the limit and allow the device to work up to the medical device damage limit (para. 0082). Therefore as Smith teaches that once a set limit is reached, multiple options (including increasing suction per para. 0089) are to be chosen from, and as Meganck teaches that once a limit is reaching an override option is presented to the user, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to require a user input for overriding the limit lock if the limit is reached and the user desires suction to still increase, as a means to notify when the limit is passed and to selectively allow for greater pressure as required.
Regarding Claim 5, Smith, Martuch, and Meganck teach
The method of claim 2, further comprising: receiving, at the user interface, a fourth input from the user to the prompt, wherein the controller is configured to deactivate the suction limit lock in response to the fourth input; receiving the third input from the user, wherein the adjustment of the suction limit above the selected vacuum level is permitted; and operating the vacuum source to adjust the actual vacuum level based on the adjustment of the suction limit (para. 0089 of Smith in view of Meganck). The examiner notes that under the rejection of claim 2, it was found obvious in view of Meganck to provide an option to disable the limit lock of Smith. The examiner notes that per para. 0089 of Smith once the limit is reached the user has options on how to modify operation of the system (increase/decrease suction, for example). Therefore as the prior art combination teaches a limit lock disable prompt and the option to further increase suction, where per claim 1 suction is controlled by the controller, it is interpreted that he combination of arts reads to the claimed limitation.
Regarding Claim 10, Smith discloses
A method of operating a medical waste collection system (abstract) including a waste canister(fig. 1 (112)), a vacuum source (para. 0032-0033 disclosing a vacuum source), a user interface (140), and a controller (fig. 3 controller (210))), the method comprising: receiving, at the user interface, a first input from a user indicative of a suction limit (para. 0038, where the user may set a vacuum level, alternatively the user can set an alarm threshold); controlling, with the controller (para. 0038), operation of the vacuum source such that an actual vacuum level generated by the vacuum source does not exceed the suction limit (para. 0038 where device operates via controller using selected vacuum levels that may be adjusted in real time); receiving, at the user interface, a second input from the user to activate a suction limit lock at a selected vacuum level (lock out vacuum pressure (para. 0088) aligned with an alarm threshold, where the alarm threshold is set by the user (para. 0089-0091)); permitting, with the controller, adjustment of the suction limit below the selected vacuum level, wherein the controller is configured to operate the vacuum source to adjust the actual vacuum level based on the adjustment of the suction limit (para. 0038 where the vacuum level at which the system operates can be specified in real time); receiving, at the user interface, a third input from the user indicative of an attempt to adjust the suction limit above the selected vacuum level associated with the suction limit lock; and displaying, on the user interface, a prompt with an option to disable the suction limit lock in response to the third input.
The examiner notes however, that the lock out value is not disclosed to be set by a user.
Martuch teaches a vacuum system and is thus considered analogous to the claimed invention. Martuch teaches that a control system for a vacuum can have a lock out feature set by a doctor or nurse to prevent patient interference (para. 0022). Therefore, as Martuch teaches that lock out levels can be set by a user (therefore having a user input), it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have a user input to set the lock out pressure for the device of Smith.
The examiner notes that as detailed under the same rejection, while Smith discloses support for real time adjustment of the vacuum level, where said adjustments are interpreted as inputs. The examiner notes that in combination with the lockout level being set, an input can be provided that would exceed the lockout level. Smith discloses that when the lockout is reached, the user is prompted to take another step para. 0088, where when the lock out is initiated, the vacuum is locked and requires further input on how to operate (i.e. increase decrease suction per para. 0089)). Therefore it is interpreted that an input regarding a vacuum being above the limit may be provided. However Smith does not disclose that one of the further inputs is regarding an option to disable the suction limit.
Meganck teaches a fluid management system including vacuum (para. 0050), and is thus considered analogous to the claimed invention. Meganck teaches that when a pressure limit is determined to be exceeded by an activation, an override input is made available, where the user can select the option to exceed the limit and allow the device to work up to the medical device damage limit (para. 0082). Therefore as Smith teaches that once a set limit is reached, multiple options (including increasing suction per para. 0089) are to be chosen from, and as Meganck teaches that once a limit is reaching an override option is presented to the user, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to require a user input for overriding the limit lock if the limit is reached and the user desires suction to still increase, as a means to notify when the limit is passed and to selectively allow for greater pressure as required.
Regarding Claim 13, Smith, Martuch, and Meganck teach
The method of claim 10, further comprising: receiving, at the user interface, a fourth input from the user to the prompt, wherein the controller is configured to deactivate the suction limit lock in response to the fourth input; receiving the third input from the user, wherein the adjustment of the suction limit above the selected vacuum level is permitted; and operating the vacuum source to adjust the actual vacuum level based on the adjustment of the suction limit (para. 0089 of Smith in view of Meganck). The examiner notes that under the rejection of claim 10, it was found obvious in view of Meganck to provide an option to disable the limit lock of Smith. The examiner notes that per para. 0089 of Smith once the limit is reached the user has options on how to modify operation of the system (increase/decrease suction, for example). Therefore as the prior art combination teaches a limit lock disable prompt and the option to further increase suction, where per claim 1 suction is controlled by the controller, it is interpreted that he combination of arts reads to the claimed limitation.
Regarding Claim 14, Smith, Martuch, and Meganck teach
The method of claim 10, wherein the medical waste collection system includes memory (para. 0040) storing data indicative of a maximum suction level associated with a respective one of predetermined clinical procedures (para. 0093, where the user can select operation based on pre-programmed procedures), wherein the method further comprises: receiving, at the user interface, a selection of one of the predetermined clinical procedures(para. 0093); and automatically activating the suction limit lock and setting the selected vacuum level to be equal to the maximum suction level associated with the selected one of the predetermined clinical procedures (where the alarm threshold is set based on the selected procedure. The examiner notes that per the rejection of claim 1 (para. 0088) the alarm threshold is indicative of the suction limit lock, as once the threshold is reached the lock takes effect).
Claim(s) 7,15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith in view of Martuch and further in view of Jalgaonkar et al. US 2021/0220528, hereafter Jalgaonkar and Wallace et al. US 2001/0027791, hereafter Wallace.
Regarding Claim 7, Smith and Martuch teach
The method of claim 1, further comprising displaying, on the user interface, a graphical representation of an operating range of the vacuum source (para. 0046, where the user interface is graphical presenting information), however, the prior art does not disclose a visual marking overlying or adjacent the graphical representation that is indicative of the suction limit.
Jalgaonkar teaches a medical aspiration system and is thus considered analogous to the claimed invention. Jalgaonkar teaches that in such system, user interfaces present information such that a user can see said information, where said information includes display of vacuum level and display of maximum vacuum limit (para. 0114). Therefore as Jalgaonkar teaches that to aid in monitoring the pressure system, current vacuum and vacuum limits are parameters displayed on the user interface, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide an indication of the lock out value on the graphical user interface of smith.
Further the combination of prior arts fails to specifically teach an indicia near the vacuum meter that is indicative of the suction limit lock being activated.
Wallace teaches a medical pressure control system and is thus considered analogous to the claimed invention. Wallace teaches that as a means to show a locked status of operation a padlock icon is used to indicate that the system is locked or unlocked in a form of an open or closed padlock (para. 0080). Therefore as a means for indicating the status of the suction lock of Smith, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to use a padlock icon capable of showing as open or closed to indicate the lock status of the suction, as such icons are known in the art to show lock status, per Wallace.
Regarding Claim 15, Smith, Martuch, and Meganck teach
The method of claim 10, further comprising displaying, on the user interface, a vacuum meter of an operating range of the vacuum source (para. 0046, where the user interface is graphical presenting information), however, the prior art does not disclose a visual marking overlying the vacuum meter that is indicative of the suction limit.
Jalgaonkar teaches a medical aspiration system and is thus considered analogous to the claimed invention. Jalgaonkar teaches that in such system, user interfaces present information such that a user can see said information, where said information includes display of vacuum level and display of maximum vacuum limit (para. 0114). Therefore as Jalgaonkar teaches that to aid in monitoring the pressure system, current vacuum and vacuum limits are parameters displayed on the user interface, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide an indication of the lock out value on the graphical user interface of smith.
Further the combination of prior arts fails to specifically teach an indicia near the vacuum meter that is indicative of the suction limit lock being activated.
Wallace teaches a medical pressure control system and is thus considered analogous to the claimed invention. Wallace teaches that as a means to show a locked status of operation a padlock icon is used to indicate that the system is locked or unlocked in a form of an open or closed padlock (para. 0080). Therefore as a means for indicating the status of the suction lock of Smith, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to use a padlock icon capable of showing as open or closed to indicate the lock status of the suction, as such icons are known in the art to show lock status, per Wallace.
Claim(s) 8,9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith in view of Martuch, Jalgaonkar, and Wallace and further in view of Humayun et al. US 2009/0143734, hereafter Humayun.
Regarding Claim 8, Smith, Martuch, and Jalgaonkar teach
The method of claim 7, but fail to teach wherein the graphical representation is arcuate vacuum meter including colored zones representative of low suction, medium suction, and high suction.
Humayun teaches a medical system including use of a suction (para. 0053) and is thus considered analogous to the claimed invention. Humayun teaches that such systems include status indicators for the user to understand the status of the device, where said indicators include LEDs (para. 0065). Per para. 0065, the LEDs are configured to light differently depending on the vacuum level, where red is unacceptable vacuum, yellow is approaching unacceptable, and green is acceptable. The examiner notes that further per para. 0065, instead of acceptable vacuum, the lights can correspond to speed or energy level (indicative of vacuum output), where the indicators show a high speed, intermediate speed, and low speed. Humayun teaches that said LEDs allow for the operation to be seen even in dark rooms (para. 0066). Therefore, as Humayun teaches that to effectively show operating parameters of a device, LEDs are used to distinguish between high, intermediate, and low vacuum levels it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide the device of Smith with such LEDs as a means for the user to be notified of the suction output.
Regarding Claim 9, Smith, Martuch, Jalgaonkar, Wallace and Humayun teach
The method of claim 8, wherein the indicia of the suction limit lock is a padlock icon positioned on a concave side of the arcuate vacuum meter. The examiner notes that as detailed under the rejection of claim 7 Wallace, found obvious to combine with the previous prior arts teaches that the indicia used to show the lock status is a padlock.
Allowable Subject Matter
Claim 3-4,11-12 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Regarding Claim 3 and 11, the previously presented prior arts do teach the method of claim 2, wherein the user interface includes a rotatable knob (Smith para. 0046, where vacuum inputs may be from a dial), but fail and wherein the method further comprises: receiving, at the user interface, the third input by rotation of the rotatable knob (para. 0046). However the prior arts fail to teach the step of determining, with the controller, a desired rate of increase of the suction limit based on a speed with which the rotatable knob is rotated; and displaying, on the user interface, the prompt if the desired rate of increase exceeds a predetermined threshold. The prior art makes no indication that the speed at which the knob is turned determines the desired suction increase. Wallace, as applied to claims 7 and 15, does teach that a knob may be turned to display values, where the speed of the knob determines the speed at which the display is altered (para. 0011, 0048), however Wallace is directed to a display and not a functional operation of the device, specifically where said function includes the treatment of a patient. Therefore it would not be obvious to combine Smith and Wallace in a manner that would read to claim 3 and 11.
Regarding Claim 4 and 12 the previously presented prior arts do teach the method of claim 2, wherein the user interface includes a rotatable knob (Smith para. 0046, where vacuum inputs may be from a dial), but fail and wherein the method further comprises: receiving, at the user interface, the third input by rotation of the rotatable knob (para. 0046). However the prior arts fail to teach the step of receiving, at the user interface, at least one additional input by a separate, further rotation of the rotatable knob that are indicative of additional attempt to adjust the suction limit above the selected vacuum level; and displaying, on the user interface, the prompt if a quantity of the additional inputs exceeds a predetermined threshold. The prior art makes no indication that the user must provide an further input in the form of another knob adjustment where said amount of attempts is displayed. Upon search, the examiner found no better art to teach this limitation than the art previously provided under the rejection.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Matthew Wrubleski whose telephone number is (571)272-1150. The examiner can normally be reached M-F 8:00-4:00 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached at 571-270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MATTHEW WRUBLESKI/Examiner, Art Unit 3781 /REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781