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 Amendment
This Office Action is in response to a preliminary amendment filed on 5/9/2024. As directed by the preliminary amendment, no claims were canceled, claims 1-10 were amended, and no new claims were added. Thus, claims 1-10 are pending for this application.
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,” and are 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: “fixation means for a fluid connection between the nasal or pharyngeal space of the patient and the second pump unit” in claim 8 lines 4-6.
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. Specifically, the corresponding structure of the “fixation means” of claim 8 as described in paragraph [0051] include: a clamping collar and clamping piece.
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 § 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 1-10 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.
Regarding claim 1, the phrases “expiratory aspiration of breathing gas and inspiratory recirculation of the aspirated breathing gas by a second of the two pump units can be set” in lines 8-11 and “wherein the second pump unit is fluidically connected in the region between the filter and the patient interface or, in the case of non-invasive ventilation, can be fluidically connected through the patient interface to the nasal or pharyngeal space of the patient” in lines 16-20 renders the claim(s) indefinite because the claim(s) include(s) elements not actually disclosed (those encompassed by "can be"), thereby rendering the scope of the claim(s) unascertainable. See MPEP § 2173.05(d).
Regarding claim 1, the phrase “a first of the two pump units essentially operates in a manner opposite the second pump unit” in lines 11-12 is unclear. The term “essentially” is a relative term which renders the claim indefinite, and is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Furthermore, the phrase “operates in a manner opposite the second pump unit” is unclear as to the meaning of “in a manner opposite” in this context (what does “opposite”? Opposite flow direction?). Additionally, the phrase “in a manner” is unclear whether the arrangement following the phrase is an example or the definitive arrangement.
Regarding claim 1, the phrase “and comprises two separately controllable pump units, each including a reservoir unit and a control unit so that expiratory aspiration of breathing gas and inspiratory recirculation of the aspirated breathing gas by a second of the two pump units can be set” in lines 6-11 is unclear whether the dead space minimization system or each of the pump units include a control unit (unclear whether one or two control units are being claimed). For the purpose of examination, examiner has interpreted claim to mean that the dead space minimization system includes the control unit, not each of the pumps, as depicted in Fig. 1 of applicant’s originally filed drawings 5/9/2024.
Regarding claim 1, the phrase "in particular" in line 14 renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
The remaining claims are rejected due to dependence on a rejected base 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.
Claim(s) 1-5 and 7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gründler (US 2020/0121872).
Regarding claim 1, Gründler discloses (Figs. 1-2) a system for supporting pulmonary gas exchange in a patient (Abstract), comprising:
a ventilating system, which comprises
a ventilating device (central unit 48, having a pump, controller, user interface and the like, paragraph [0061])
a Y-piece (y-piece 50),
a filter (filter 52), and
a patient interface (endotracheal tube 45),
and comprising a dead space minimization system (comprising components of first and second pathways 63,64, see Fig. 2) that is fluidically coupled to the ventilating system (via hosing 5,55) and comprises two separately controllable pump units (pump 14 of first pathway 63 and pump 57 of second pathway 64), each including a reservoir unit (reservoir 12 of first pathway 63, reservoir 58 of second pathway 64) and a control unit (controller 37) so that expiratory aspiration of breathing gas and inspiratory recirculation of the aspirated breathing gas by a second of the two pump units (pump 15) can be set (paragraph [0058] and [0065]), and
a first of the two pump units (pump 57) essentially operates in a manner opposite the second pump unit (paragraphs [0065]-[0066]), the first pump unit being fluidically connected in the region between the ventilating device and the filter (see Fig. 2), and in particular between the Y-piece and the filter (see Fig. 2), wherein the second pump unit is fluidically connected in the region between the filter and the patient interface (see Fig. 2).
Regarding claim 2, Gründler discloses wherein the ventilating system comprises an aspiration system (single use aspiration catheter introduced into duckbill valve of second connector 54, paragraph [0070]) between the filter and the patient interface (see Fig. 2), and the second pump unit is fluidically connected in the region between the aspiration system and the patient interface (second pump unit 15 is fluidly connected to the patient interface and thus fluidly connected in the region between the aspiration system and the patient interface).
Regarding claim 3, Gründler discloses wherein the second pump unit is fluidically connected to the ventilating system so that a gas flow from the second pump unit joins the ventilating system at an angle of 0° to 70° (shown in Fig. 2, the angle at connection of cable 5 of second pump unit 15 and connector 54 is between 0° to 70°, and thus comprehends the claim limitation).
Regarding claim 4, Gründler discloses wherein a gas flow from the second pump unit joins the ventilating system so that the gas flow from the second pump unit, when joining, has a directional component parallel to a gas flow of the ventilating system toward the ventilating device (parallel to exhalation flow toward ventilating device 48 shown in Fig. 2).
Regarding claim 5, Gründler discloses wherein a gas flow leaves the ventilating system toward the second pump unit so that the gas flow toward the second pump unit, when leaving, has a directional component parallel to a gas flow of the ventilating system toward the ventilating device (gas flow toward pump unit parallel to flow toward ventilating device 48 shown in Fig. 2).
Regarding claim 7, Gründler discloses the second pump unit is fluidically connected to the ventilating system so that a mouth for a gas flow from and to the second pump unit is formed by an appendage protruding into the interior of a connector (catheter 9 protruding from interior of connector 54, see Fig. 2 and paragraph [0058]).
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.
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.
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.
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.
Claim(s) 6 is rejected under 35 U.S.C. 103 as being unpatentable over Gründler (US 2020/0121872) in view of Millar (US 10,898,667).
Regarding claim 6, Gründler discloses second pump unit is fluidically connected to the ventilating system, but does not disclose the fluidic connection is carried out via alternating mouths.
However, Millar teaches (Fig. 1-2D) second pump unit (suction system connected to catheter 160) that is fluidically connected to the ventilating system (ventilating system 12), wherein the fluidic connection is carried out via alternating mouths (catheter 160 is inserted into catheter mount 200a at alterntating positions and thus establishes fluid connection via alternating mouths (mouth, i.e. opening, of catheter 160 alternates from two positions depending on application, Col. 6 lines 60-68).
Therefore, 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 fluid connection of Gründler to be carried out via alternating mouths, as taught by Millar, for the purpose of allowing for allowing the suction catheter to be inserted into different positions so that catheter mount does not have to be removed from the system when different positioning is required (Col. 6 lines 60-68 Millar).
Claim(s) 8-10 is rejected under 35 U.S.C. 103 as being unpatentable over Gründler (US 2020/0121872) in view of Burgess (US 20240261523)
Regarding claim 8, Gründler discloses a patient interface, but does not disclose the patient interface is a face mask or a ventilation helmet for non-invasive ventilation and has a sealing through-passage comprising fixation means for a fluid connection between the nasal or pharyngeal space of the patient and the second pump unit.
However, Burgess teaches (Figs. 1 and 31-33) patient interface that can be in the form of an endotracheal tube (endotracheal tube 126 in Fig. 33) for invasive ventilation, or a face mask (mask 124) for non-invasive ventilation and has a sealing through-passage (comprising mask and associated tubing that is sealed due to sealing of mask, paragraph [0351]) comprising fixation means (sealing rim of mask 124) for a fluid connection between the nasal or pharyngeal space of the patient and the second pump unit (paragraph [0351]).
Therefore, 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 patient interface of Gründler to include a face mask or a ventilation helmet for non-invasive ventilation and has a sealing through-passage comprising fixation means for a fluid connection between the nasal or pharyngeal space of the patient and the second pump unit, as taught by Burgess, for the purpose of allowing a user to utilize the device without requiring invasive setup.
Regarding claim 9, Gründler discloses a patient interface, but does not disclose, wherein the patient interface is a face mask or a ventilation helmet for non-invasive ventilation and comprises an interface connector for connecting a fluid connection to the second pump unit and a patient hose for the fluidic connection to the nasal or pharyngeal space of the patient.
However, Burgess teaches (Figs. 1 and 31-33) patient interface that can be in the form of an endotracheal tube (endotracheal tube 126 in Fig. 33) for invasive ventilation, or a face mask (mask 124) for non-invasive ventilation and comprises an interface connector (switch 1600) for connecting a fluid connection to the second pump unit and a patient hose for the fluidic connection to the nasal or pharyngeal space of the patient (allows connection and switching of connection between user interfaces and the second pump unit, paragraph [0380]).
Therefore, 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 patient interface of Gründler to include a face mask or a ventilation helmet for non-invasive ventilation and comprises an interface connector for connecting a fluid connection to the second pump unit and a patient hose for the fluidic connection to the nasal or pharyngeal space of the patient., as taught by Burgess, for the purpose of allowing a user to utilize the device without requiring invasive setup, as well as to allow switching between user interfaces based on user condition and treatment required.
Regarding claim 10, modified Gründler discloses the system comprises a nasal prong (nasal prong 224 of Burgess that delivers positive airflow to user wearing the mask 124, paragraph [0348]) for the fluidic connection to the nasal or pharyngeal space of the patient (paragraph [0348]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Tapperhorn (US 2021/0228831) discloses a system having an aspiration assembly.
Fitzgerald (US 6,269,813) discloses a system having a ventilator device and suction/negative pressure assembly.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW R MOON whose telephone number is (571)272-2554. The examiner can normally be reached Monday-Thursday 7:30am-5:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Timothy Stanis can be reached at 571-272-5139. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW R MOON/Examiner, Art Unit 3785
/TIMOTHY A STANIS/Supervisory Patent Examiner, Art Unit 3785
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