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 .
This office action is in response to the preliminary amendment filed 2/5/25. As directed by the amendment, claims 1-7 have been cancelled and claims 8-27 have been added. As such, claims 8-27 are pending in the instant application.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
Note: the term “means” (line 3) is improper language for an abstract.
Claim Objections
Claim 11 is objected to because of the following informalities: the language “the expiration phase” (line 2) is objected to for not maintaining consistency in claim terminology; Examiner suggests amending to read –the expiratory phase—to match language in claim 8 line 3. Appropriate correction is required.
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 use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are: “pneumatic means and/or electronic means” in claim 9 and 18.
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends 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 remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
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 8-14, 16-17, and 24-25 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.
Claim 8 recites the limitation "the inspiratory airway pressure" in line 5. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites the limitation "the expiratory line" in line 7-8. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 16, the language “The method of claim 9” (line 1) renders the claim unclear/indefinite as claim 9 sets forth a system type claim and not a method type claim. For purposes of expedited examination, this claim will be examined as if dependent on claim 15.
Regarding claim 17, the term “a block wave” (line 2) is unclear as the examiner cannot ascertain the meaning of this limitation/term which does not appear to be a commonly used term in the art and the disclosure does not provide further defining of this term.
Claim 24 recites the limitation "the monitored inspiratory flow" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 25 recites the limitation "the expiratory line" in line 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claims 9-14 are rejected based on dependency on a rejected claim.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 8-9, 11-16, 18, and 21 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Troili et al. (2014/0116439).
Regarding claim 8, Troili discloses a system for providing balanced respiratory actuation of a patient in which the system is connected to a respiratory apparatus for breathing (see Fig. 1-2 and para. 0055, respiratory apparatus 1, patient 2), the respiratory actuation including inspiratory and expiratory phases during which respectively inspiration and expiration of the patient takes place (see Fig. 2 and para. 0057 for example), the system comprising a controller (controller 5, see Fig. 1 and para. 0056) for executing a control algorithm that monitors inspiratory air pressure and from which defines a trajectory of the inspiratory phase (see para. 0056, 0058, 0060-0063, Fig. 1 for example, via sensors 4a-c, Fig. 2-8 showing defined trajectories of inspiration and expiration); and based on the trajectory, dynamically adjust a flow of pressurized air in the expiratory line herewith controlling a lung or airway pressure toward a predetermined trajectory based on the monitored inspiratory airway pressure and resembles in shape the trajectory of the inspiratory phase (see Fig. 1, expiratory line 9, Fig. 2-3 and 7-8 showing predetermined trajectory of the expiratory line/lung pressure that resembles in shape the inspiratory trajectory; see para. 0057-0063, 0068-0069, 0073-0074, 0090 which discloses monitoring inspiratory airway pressure to determine final phase of inspiration and exhalation effort and based thereon determines the trajectory of the expiratory phase to provide smooth respiratory curves for patient comfort, para. 0074; trajectory/pressure curve controlled by controller via pressure regulator 3 including expiratory valve 3b).
Regarding claim 9, the Troili system’s dynamic adjustment of the flow of pressurized air in the expiratory line is done by pneumatic means and/or electronic means (see Fig. 1 and para. 0057, 0059, 0063; expiratory valve 3b controls flow and thus is a ‘pneumatic means’ and which is controlled by controller 5 which includes a processor 14 or external computer and thus is an ‘electronic means’).
Regarding claim 11, the Troili system’s controller is configured to take expiration measurements during the expiratory phase and the flow of pressurized air is dynamically adjusted based thereon (see para. 0056, 0061, 0063, 0065, 0069 for example).
Regarding claim 12, the Troili system’s controller is configured to start after a set and/or computed time period and/or a certain condition is satisfied after inspiration ends (see Fig. 2 and para. 0068, end of inspiration triggers controller to control expiratory trajectory).
Regarding claim 13, the Troili system’s controller is configured to stop after a set and/or computed time period and/or a certain condition is satisfied after inspiration ends (system and controller inherently able to be stopped after a certain condition such as decision by a clinician to remove patient from breathing apparatus and power off the system).
Regarding claim 14, the Troili system’s control of the lung/airway pressure toward a predetermined trajectory includes a decrease of the lung/airway pressure (see Fig. 2-3 and 7-8 which shows predetermined trajectory of the expiratory phase is a decrease in pressure).
Regarding claim 15, the use of the Troili system discloses a method for providing a balanced respiratory actuation of a patient connected to a respiratory apparatus for breathing (see Fig. 1-2, para. 0055, respiratory apparatus 1, patient 2) the respiratory actuation including inspiratory and expiratory phases during which respectively inspiration and expiration of the patient takes place (see Fig. 2 and para. 0057 for example), the method including during the inspiratory phase, monitoring inspiratory behavior (see para. 0056, 0058, 0060-0063, 0068, Fig. 1 for example, via sensors 4a-c); during the expiratory phase, controlling the expiration by limiting or restricting the expiratory flow to control lung or airway pressure toward a predetermined trajectory based on the monitored inspiratory behavior and resembling in shape a trajectory of the monitored inspiratory behavior (see Fig. 2-3 and 7-8 showing predetermined trajectory of the expiratory line/lung pressure that resembles in shape the inspiratory trajectory; see para. 0057-0063, 0068-0069, 0073-0074, 0090 which discloses monitoring inspiratory airway pressure to determine final phase of inspiration and exhalation effort and based thereon determines the trajectory of the expiratory phase to provide smooth respiratory curves for patient comfort, para. 0074; trajectory/pressure curve controlled by controller via pressure regulator 3 including expiratory valve 3b).
Regarding claim 16, the Troili method controls the expiration by linearly decreasing the lung/airway pressure during the expiratory phase (see Fig. 2-3 and 7-8, para. 0073).
Regarding claim 18, the Troili method controls expiration by pneumatic and/or electronic means (see Fig. 1 and para. 0057, 0059, 0063; expiratory valve 3b controls flow and thus is a ‘pneumatic means’ and which is controlled by controller 5 which includes a processor 14 or external computer and thus is an ‘electronic means’).
Regarding claim 21, the Troili method further includes taking expiration measurements during expiration and controlling the expiration based thereon (see para. 0056, 0061, 0063, 0065, 0069 for example).
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.
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) 10 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Troili in view of Frank et al. (5,063,925).
Regarding claim 10, the Troili system’s flow of pressurized air in the expiratory line is adjusted by controlling a position of an expiratory valve (see para. 0057 and 0059, expiratory valve 3b to provide controlled expiration trajectory which would appear to read on a proportional valve), but is silent as explicitly disclosing this being done by controlling a position of a membrane or actuation of a proportional valve (Troili para. 0057 discloses that any type of known pressure regulator 3 can be used); however, Frank teaches a similar system which includes such an expiratory valve (see Frank Fig. 1-2a, abstract, col. 2 ln. 21-52, col. 3 ln. 34-42, col. 3 ln. 61 through col. 4 ln. 6, membrane 5). Thus it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Troili system’s expiratory valve to be a membrane type or proportional valve, as taught by Frank, as this would have been obvious substitution of one known element for another and one would expect the modified Troili system to perform equally as well.
Regarding claim 19, the Troili method controls a position of an expiratory valve to control pressure in an expiratory line via control signals (see para. 0057 and 0059, expiratory valve 3b to provide controlled expiration trajectory which would appear to read on a proportional valve; Fig. 1, expiratory line 9, expiratory valve 3b; para. 0063 which discloses control program stored on memory and executed by a processor or external computer which would provide control signals to the pressure regulator 3), but is silent as explicitly disclosing this being done by controlling a position of a membrane or actuation of a proportional valve (Troili para. 0057 discloses that any type of known pressure regulator 3 can be used); however, Frank teaches a similar system which includes such an expiratory valve (see Frank Fig. 1-2a, abstract, col. 2 ln. 21-52, col. 3 ln. 34-42, col. 3 ln. 61 through col. 4 ln. 6, membrane 5). Thus it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Troili method’s expiratory valve to be a membrane type or proportional valve, as taught by Frank, as this would have been obvious substitution of one known element for another and one would expect the modified Troili method to perform equally as well.
Claim(s) 17 is/are rejected under 35 U.S.C. 102(a)(1) or (a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Troili.
Regarding claim 17, the Troili method’s pressure curve per breath appears to be an obtained flow curve as a block wave (see Fig. 2-3 and 7-8 for example which appears to show a block shape as the curve per breath is a truncated triangular shape); however, in the alternative it would have been obvious to one of ordinary skill in the art to modify the Troili method’s pressure curve per breathing to be an isosceles triangle or explicit block shape as this would have been obvious design modifications of the shape of the curve and would provide a patient with an alternative pressure trajectory and would have been obvious to try.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Troili in view of Mechlenburg et al. (2011/0232643).
Regarding claim 20, the Troili method is silent as to the controlling of expiration starting after a predetermined number of inspiration/expiration cycles; however, Mechlenburg teaches a similar respiratory method which includes a delay period (number of breath cycles) before controlling/adjusting pressure (see Mechlenburg Fig. 4, 6, 7 for example). Thus it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Troili method to start control of the expiration after predetermined number of breath cycles, as suggested by Mechlenburg, in order to provide a varied pressure curve to the patient and which would have been obvious to apply such a ramped pressure control for gradual changing of pressure waveform (Mechlenburg para. 0025).
Claim(s) 22-24 and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Troili in view of Lindstrom et al. (2015/0238724).
Regarding claim 22, the use of the Troili system discloses a method for providing a balanced respiratory actuation of a patient connected to a respiratory apparatus for breathing (see Fig. 1-2, para. 0055, respiratory apparatus 1, patient 2) the respiratory actuation including inspiratory and expiratory phases during which respectively inspiration and expiration of the patient takes place (see Fig. 2 and para. 0057 for example), the method including during the expiratory phase, controlling expiration by limiting an expiratory flow (see Fig. 1, expiration controlled by controlling expiratory flow in expiratory limb 9 via expiratory valve 3b, see para. 0059); and during the inspiratory phase, controlling inspiration by active ventilation or supply of pressurized air to the patient (see Fig. 1, controlled pressurized inspiratory air provided via inspiratory valve 3a via inspiratory line 6 from gas sources 8a-c, see para. 0058). The Troili method is silent as to the patient connected to the respiratory apparatus being for breathing during anesthesia; however, Lindstrom teaches a similar system/method which includes a substantially similar respiratory apparatus (Lindstrom Fig. 1) and which is for use for breathing during anesthesia (see Lindstrom para. 0017). Thus it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Troili method to be used for a patient who requires controlled breathing during anesthesia, as taught by Lindstrom, as it is well-known to provide for such ventilation and would have been obvious to try/use on a patient breathing during anesthesia.
Regarding claim 23, the modified Troili method includes monitoring inspiratory behavior during the inspiratory phase (see Troili para. 0056, 0058, 0060-0063, 0068, Fig. 1 for example, via sensors 4a-c); and controlling expiration during the expiratory phase based thereon (see Fig. 2-3 and 7-8 showing predetermined trajectory of the expiratory line/lung pressure that resembles in shape the inspiratory trajectory; see para. 0057-0063, 0068-0069, 0073-0074, 0090 which discloses monitoring inspiratory airway pressure to determine final phase of inspiration and exhalation effort and based thereon determines the trajectory of the expiratory phase to provide smooth respiratory curves for patient comfort, para. 0074; trajectory/pressure curve controlled by controller via pressure regulator 3 including expiratory valve 3b).
Regarding claim 24, the modified Troili method is such that maximum expiratory flow is approximately equal to the maximum of the monitored inspiratory flow (see Fig. 2, max flows being at the peak of the curve).
Regarding claim 27, the modified Troili method includes starting control of the expiration after a predetermined time period and/or computed time period and/or certain condition satisfied after inspiration ends (see Troili Fig. 2 and para. 0068, end of inspiration triggers controller to control expiratory trajectory) and/or stopping control of expiration after predetermined time period and/or computed time period and/or certain condition satisfied after inspiration ends (system and controller inherently able to be stopped after a certain condition such as decision by a clinician to remove patient from breathing apparatus and power off the system).
Claim(s) 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Troili and Lindstrom as applied to claim 22 above, and further in view of Frank.
Regarding claim 25, the modified Troili method controls a position of an expiratory valve to control pressure in an expiratory line via control signals (see Troili para. 0057 and 0059, expiratory valve 3b to provide controlled expiration trajectory which would appear to read on a proportional valve; Fig. 1, expiratory line 9, expiratory valve 3b; para. 0063 which discloses control program stored on memory and executed by a processor or external computer which would provide control signals to the pressure regulator 3), but is silent as explicitly disclosing this being done by controlling a position of a membrane or actuation of a proportional valve (Troili para. 0057 discloses that any type of known pressure regulator 3 can be used); however, Frank teaches a similar system which includes such an expiratory valve (see Frank Fig. 1-2a, abstract, col. 2 ln. 21-52, col. 3 ln. 34-42, col. 3 ln. 61 through col. 4 ln. 6, membrane 5). Thus it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified Troili method’s expiratory valve to be a membrane type or proportional valve, as taught by Frank, as this would have been obvious substitution of one known element for another and one would expect the modified Troili method to perform equally as well.
Claim(s) 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Troili and Lindstrom as applied to claim 22 above, and further in view of Zdrojkowski et al. (5,803,065).
Regarding claim 26, the modified Troili method takes expiration measurements and controls expiration based thereon (see Troili para. 0056, 0061, 0063, 0065, 0069 for example), but is silent as to explicitly taking the measurements at discrete time intervals; however, taking sensor measurements during discrete intervals is well-known in the art and further taught by Zdrojkowski (see Zdrojkowski col. 13 ln. 42-50). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified Troili method to take measurements during discrete time intervals, as taught by Zdrojkowski, as this would have been obvious to try and one would expect the modified Troili method to perform equally as well.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Dahlstrom et al. (2010/0252046)discloses an expiratory valve for exhalation control in an anesthetic system; Maxin et al. (RU 107481) discloses a ventilation system including a pneumatic controlled membrane type exhalation valve; Masic et al. (2012/0272961) discloses a system for exhalation trajectory control; Hansmann et al. (2018/0110957) discloses a system including an exhalation valve providing regulated PEEP; and Yurko (6,532,960) discloses a system for providing balanced respiratory actuation.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to COLIN W STUART whose telephone number is (571)270-7490. The examiner can normally be reached M-F: 9-5.
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/COLIN W STUART/Primary Examiner, Art Unit 3785
