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 .
Election/Restrictions
Applicant’s election without traverse of Species A (claims 1-14) in the reply filed on 06 Jan 2025 is acknowledged. Claims 15-39 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the pump (claim 13) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Interpretation - 35 USC § 112(f)
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “gas delivery unit” in claim 1.
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.
The corresponding structure for the “gas delivery unit” is best understood from the specification as at least: gas delivery unit 112 is configured to use valves and/or pressure regulators to control the pressure, flow rate, and/or gas composition of the gas (¶0038 of the PGPub copy of the instant application).
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim 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 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) 1, 7-8 and 14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Doyle et al. (U.S. Pub. 2014/0123979).
Regarding claim 1, Doyle discloses a mechanical ventilator system (Fig. 1) comprising: a sensor (Fig. 1 #107; ¶¶0035, 0038, 0058, 0060) configured to measure a neurological parameter; a memory device (Fig. 1 #112) storing a closed loop control algorithm (e.g. Figs. 2-6 – looped controls related to patient’s signals) that relates neurological parameter values to ventilation modes including a mandatory breath mode (¶¶0202-0209), a spontaneous breath mode (¶¶0212-0213), and a mixed mode (¶¶0212, 0214); a mechanical ventilator (Fig. 1 #100; ¶0043) including a gas delivery unit (Fig. 1 #102, 104, 108; ¶¶0045-0047) configured to control a flow of gas from at least one gas source to a patient; and a processor (Fig. 1 #116) communicatively coupled to the sensor, the memory device, and the gas delivery unit, the processor configured to: receive respiratory treatment settings for a patient (¶¶0053-0054 – required for operation), at least one of the respiratory treatment settings specifying one of the ventilation modes as a programmed ventilation mode (¶0056 – operator selection), control the gas delivery unit to administer a respiratory treatment according to the treatment settings including the programmed ventilation mode (standard operation), receive a signal from the sensor (¶0060), determine a neurological parameter value from the signal (¶¶0035, 0038, 0058, 0060, 0085-0088, 0110 – fatigue indicator from work of breathing and/or bispectral index), use the closed loop control algorithm and the neurological parameter value to determine the programmed ventilation mode is to be adjusted to another one of the ventilation modes as an adjusted ventilation mode (e.g. Fig. 3C #216; ¶¶0355-0366 – based on fatigue indicator), and control the gas delivery unit to administer the respiratory treatment according to the adjusted ventilation mode (Fig. 3C #216 – mode changed). The portions of Doyle cited herein are meant to be representative of the invention of Doyle and are not to be construed as limiting on the possible reading of further passages on the claim(s).
Regarding claim 7, Doyle discloses the mandatory breath mode includes at least one of an assisted/controlled mechanical ventilation ("A/CMV") mode, a volume control ("VC") mode, a pressure control ("PC") mode, a pressure regulated volume control ("PRVC") mode, and a mode analog to one of these modes (¶¶0202-0209), the spontaneous breath mode includes at least one of a continuous positive airway pressure ("CAPC") mode, a pressure support ventilation ("PSV") mode, a volume support ventilation ("VS") mode, a proportional assist ventilation ("PAV") mode, a high flow oxygen therapy ("HFOT") mode, and a mode analog to one of these modes (¶¶0212-0213), and the mixed mode includes at least one of a synchronized intermittent mechanical ventilation ("SIMV") mode, a bilevel positive airway pressure ("BiPAP") mode, and a mode analog to one of these modes (¶¶0212, 0214).
Regarding claim 8, Doyle discloses the sensor is remote from the mechanical ventilator (¶¶0035, 0038, 0048, 0058, 0060 – attached to the body of the patient) and communicatively coupled to the processor via at least one of a directed wired connection, a wireless connection, or a network connection (¶0049 – the sensor must either be wired or wireless).
Regarding claim 14, Doyle discloses the processor and the memory device are one of: separate from the mechanical ventilator; or included within the mechanical ventilator (Fig. 1; ¶0053).
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 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 2-6 and 9-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Doyle et al. (U.S. Pub. 2014/0123979) in view of Lacey et al. (U.S. Pub. 2022/0395665).
Regarding claim 2, Doyle discloses a bispectral index ("BIS") value (¶¶0058, 0110), wherein the adjusted ventilation mode is the mandatory breath mode (Fig. 3 #216; ¶¶0357-0358 – changed to mandatory mode when patient fatigued), and wherein the processor is configured to switch to the mandatory breath mode when the BIS value falls below a threshold (¶¶0086, 0110 – below normal).
Doyle fails to discloses (i) the sensor includes electroencephalogram ("EEG") sensors to determine the BIS value as the neurological parameter value, or (ii) the sensor includes a BIS monitor that provides the BIS value based on measured EEG signals. Doyle is sent as to whether the BIS value is determined from a measured EEG signal.
Lacey teaches an anesthesia system and teaches it is known in the art to determine a BIS value with a BIS monitor which analyzes the complexity of electroencephalographic (EEG) data (¶0003).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have incorporated in Doyle the sensor includes a BIS monitor that provides the BIS value based on measured EEG signals in order to have specified how the BIS value in Doyle is determined based on the known technique in the art of determining a BIS value with a BIS monitor which analyzes the complexity of electroencephalographic (EEG) data in view of Lacey.
Regarding claim 3, Doyle teaches the invention as modified above and further teaches the threshold is
Regarding claim 4, Doyle teaches the invention as modified above and further suggests as obvious the processor is further configured to, after switching to the mandatory breath mode, refrain from performing at least one of: a spontaneous breath trial (¶0229 – no breath trial during rest time), a P0.1 measurement using a pressure sensor of the mechanical ventilatorbreath mode. The claim does not require the P0.1 measurement to need to be performed at any other point in time.
Regarding claim 5, Doyle teaches the invention as modified above and further suggests as obvious the adjusted ventilation mode is the mixed mode or the spontaneous breath mode (Fig. 3 #216; ¶¶0357-0360 – changed away from mandatory mode when patient no longer fatigued), and wherein the processor is configured to switch to the mixed mode or the spontaneous breath mode when the BIS value rises above the threshold (¶¶0086, 0110 – rising to be at least normal after having been below normal while fatigued).
Regarding claim 6, Doyle teaches the invention as modified above and further suggests as obvious the processor is further configured to, after switching to the mixed mode or the spontaneous breath mode, perform at least one of: a spontaneous breath trial (¶0360 – return setting operation will test for a spontaneous breath when returned to spontaneous mode), a P0.1 measurement using a pressure sensor of the mechanical ventilator (¶0058 – a P0.1 measurement can be performed)
Regarding claim 9, Doyle discloses a bispectral index ("BIS") value (¶¶0058, 0110), wherein the adjusted ventilation mode is the mandatory breath mode (Fig. 3 #216; ¶¶0357-0358 – changed to mandatory mode when patient fatigued), and wherein the processor is configured to switch to the mandatory breath mode when the BIS value falls below a threshold (¶¶0086, 0110 – below normal).
Doyle fails to disclose the sensor includes a train-of-four ("TOF") monitor and the processor is configured to determine, from the signal, a neuromuscular value as the neurological parameter value, and wherein the processor is configured to switch to the mandatory breath mode when the neuromuscular value is indicative of muscular paralysis.
Lacey teaches an anesthesia system and teaches it is known in the art to measure depth of anesthesia of a patient using either of a BIS monitor or a train-of-four monitor (¶¶0003, 0027). Lacey thus teaches that a train-of-four monitor would have been considered by one of ordinary skill in the art as an obvious design choice alternative to a BIS monitor.
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have incorporated in Doyle the sensor includes a train-of-four ("TOF") monitor and the processor is configured to determine, from the signal, a neuromuscular value as the neurological parameter value based upon an obvious design choice in the art to select between a BIS monitor or a train-of-four monitor when desired to measure depth of anesthesia of a patient in view of Lacey. As Doyle teaches switching to the mandatory breath mode when the BIS value is below normal (¶¶0086, 0110) one of ordinary skill in the art would have obvious expected the value determined from the train-of-four monitor to cause a switching to the mandatory breath mode when it similarly showed a high depth of sedation, particularly a level indicative of muscular paralysis.
Regarding claim 10, Doyle teaches the invention as modified above and further suggests as obvious the processor is further configured to, after switching to the mandatory breath mode, refrain from performing at least one of: a spontaneous breath trial (¶0229 – no breath trial during rest time), a P0.1 measurement using a pressure sensor of the mechanical ventilator
Regarding claim 11, Doyle teaches the invention as modified above and further suggests as obvious the adjusted ventilation mode is the mixed mode or the spontaneous breath mode (Fig. 3 #216; ¶¶0357-0360 – changed away from mandatory mode when patient no longer fatigued), and wherein the processor is configured to switch to the mixed mode or the spontaneous breath mode when the neuromuscular value is indicative of patient muscular activity (¶¶0086, 0110 – rising to be at least normal after having been below normal while fatigued, will similarly apply to train-of-four measure as to BIS as both are measures of sedation).
Regarding claim 12, Doyle teaches the invention as modified above and further suggests as obvious the processor is further configured to, after switching to the mixed mode or the spontaneous breath mode, perform at least one of: a spontaneous breath trial (¶0360 – return setting operation will test for a spontaneous breath when returned to spontaneous mode), a P0.1 measurement using a pressure sensor of the mechanical ventilator (¶0058 – a P0.1 measurement can be performed).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Doyle et al. (U.S. Pub. 2014/0123979) in view of Zhan (U.S. Pub. 2017/0367619).
Regarding claim 13, Doyle discloses the gas delivery unit (e.g. Fig. 1 #104, 108) includes a gas inlet (Fig. 1 from #106) fluidly coupled to the at least one gas source (Fig. 1 #106), a
Doyle fails to disclose a humidifier.
Zhan teaches that during CPAP treatment a humidifier can be included to minimize drying of the nasal mucosa and increase patient airway comfort, particularly in cooler climates (¶0017).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have incorporated in Doyle a humidifier in order to provide the benefit of minimizing drying of the nasal mucosa and increasing patient airway comfort, particularly in cooler climates, when using the ventilator in a CPAP mode in view of Zhan.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure, see PTO-892 for additional attached references. Regarding claim 1 further attention is specifically drawn to Buldeo (U.S. Pub. 2022/0331549) and its teaching of using EEG to control switching between ventilation modes (e.g. ¶¶0065-0067).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH D BOECKER whose telephone number is (571)270-0376. The examiner can normally be reached M-F 9:00 AM - 4:00 PM.
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/JOSEPH D. BOECKER/Primary Examiner, Art Unit 3785