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 1 in the reply filed on 07/16/2026 is acknowledged.
Claims 10-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Species 2, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/16/2026.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. 16/794,155, filed on 02/18/2020.
Drawings
Formal drawings require that every line, number, and letter must be durable, clean, black (except for color drawings), sufficiently dense and dark, and uniformly thick and well-defined. (37 CFR 1.84(l)). The drawings are of inadequate reproduction quality. In particular, figures 1, 4, and 11a have poor image resolution and it is difficult to visually distinguish the structures to which the leader lines point.
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 lattice mesh of claim 8 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
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 is: “a sound unit” in claim 1.
A sound unit is interpreted to be a device which reduces noise (page 20, line 29).
Because this claim limitation is being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it is being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this limitation interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitations to avoid 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 them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim terms that are considered to provide sufficient structure and do not invoke 112(f) include “a measuring unit” in claim 1, which is understood to be a sensing-type device for measuring an aspect of the operation of the respiratory device; “control unit” in claim 1, which is a known term in the art that controls the operation of a respiratory device; “pneumatic unit” which has recited structure in claim 1; “cooling unit” in claim 4, which provides sufficient structure to describe the cooling unit, and “flow measuring unit” in claim 8, which is understood to be a device such as a sensor that measures flow.
Claim Objections
Claims 2 and 9 are objected to because of the following informalities:
Claim 2, lines 13-14, “a pneumatic conveying line” has previously been recited in parent claim 1, line 4. It is suggested to amend this limitation to “[[a]] the pneumatic conveying line”.
Claim 2, line 17 recites “the cooling fan” which has not been previously recited including in parent claim 1. It is suggested to amend this limitation to “[[the]] a cooling fan”.
Claim 9 line 18 has two instances of “a quick-change adapter”. The second instance should be amended to recite “the quick-change adapter”.
Appropriate correction is required.
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.
Claim 1 is rejected under 35 U.S.C. 103 as unpatentable over DeVries et al. (US 2006/0144396 A1), hereafter DeVries, in view of Huster et al. (US 2008/0000477 A1), hereafter Huster.
Regarding Claim 1, DeVries discloses a respiratory device (fig. 1, abstract), wherein the device comprises a housing (fig. 1, enclosure 100 [0038]), a user interface (fig. 1, 106 [0039]) and a pneumatic unit; the pneumatic unit comprising at least one of each of a respiratory gas drive (fig. 3, Roots blower 300 [0048]), a measuring unit (fig. 4, transducer module 470 [0070]), a control unit (fig. 4, ventilator processor 443 [0059]) and sound unit (muffler [0142]); being designed as a pneumatic conveying line which forms a respiratory gas path (fig. 13A [0143]) from an appliance inlet (fig. 13A, 1300 [0143]) to an appliance outlet of the housing (fig. 16 to patient [0145]; see also fig. 2A, 101 [0038]), the housing comprising a top wall (see annotated fig. 1 below), at least one bottom wall (see annotated fig. 1 below) and at least two side walls (see annotated fig. 1 below), and at least one side wall being configured as a bottom wall (fig. 2, side wall is acting as a bottom wall when installed in docking cradle 200 [0044]), and wherein the respiratory device further comprises an accumulator (fig. 7, 722 [0114]).
DeVries does not disclose whether the accumulator and the respiratory gas drive are arranged in the housing in such a way that, in an orientation of the device both on the bottom wall and also on the side wall configured as bottom wall, a center of gravity is formed by the accumulator and the respiratory gas drive.
Huster teaches a respiratory therapy system (abstract) which includes a housing (fig. 12, device 300, housing 302 [0110]) which positions heavier internal components situated in the lower part of the device so that the system has a relatively low center of gravity, which enhances the system stability and reduces the tendency of the system to tip ([0111]).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to arrange DeVries’ accumulator and respiratory gas drive in the housing in such a way that, in an orientation of the device both on the bottom wall and also on the side wall configured as a bottom wall (such as the orientation of that shown in DeVries fig. 2A), a center of gravity is formed by the accumulator and the respiratory gas drive, since Huster teaches that arranging heavier components such as motors and other hardware enhances the stability of the system to prevent tipping (Huster [0111]).
Claims 2-7 and 9 are rejected under 35 U.S.C. 103 a unpatentable over DeVries and Huster, further in view of Taylor et al. (US 2017/0340847 A1), hereafter Taylor.
Regarding Claim 2, DeVries as modified discloses a respiratory device of claim 1, wherein the pneumatic unit is designed as a pneumatic conveying line (fig. 16 [0028] and [0145]) which is formed and arranged from the appliance inlet (fig. 13A, inlet 1300 [0143]) to the appliance outlet of the housing (fig. 16 “to patient” and fig. 2A, 101 [0038]), but is silent on comprises a support frame on which at least one component selected from the respiratory gas drive, the sound unit, a flow measurement path, the measuring unit and the cooling fan is arranged, the pneumatic conveying line being removable from the housing.
Taylor teaches a ventilator which includes similar components to DeVries’ device (fig. 8 [0063]) that includes a support frame for the pneumatic block module (fig. 8, 56 [0063]) which includes at least a respiratory gas drive (one or more blowers [0063]). Taylor additionally teaches that the pneumatic conveying line may be removed from the housing ([0017]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify DeVries’ pneumatic conveying line to include a support frame as taught by Taylor, in order to protect the components of the line and to reduce sound vibration (Taylor [0063]) as well as to make the pneumatic conveying line removable from the housing in order to make the components of the pneumatic conveying line serviceable or replace the components entirely (Taylor [0017]).
Regarding Claim 3, DeVries discloses a respiratory device of claim 1, but is silent on wherein at least one component of the pneumatic unit or the pneumatic conveying line is removable from the housing ([0041] only the battery is disclosed to be removeable).
However, Taylor teaches that components of a pneumatic conveying line may be removable (pneumatic block components may be removed [0017]; [0016] pneumatic block may include blower and air passages and sensors).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make at least one component of DeVries’ pneumatic unit or pneumatic conveying line removable from the housing, as taught by Taylor, in order to make the components of the pneumatic conveying line serviceable (Taylor [0017]).
Regarding Claim 4, DeVries discloses a respiratory device of claim 1, but is silent on wherein the device further comprises a cooling unit which comprises a cooling air inlet and a cooling air outlet, a cooling air path being configured and formed between the cooling air inlet and the cooling air outlet, and wherein the appliance inlet is arranged in the housing in a manner spaced apart from the cooling air outlet in such a way that no air is aspirated through the appliance inlet from the cooling air outlet.
However, Taylor teaches a similar ventilator device which includes a cooling unit (fig. 8, cooling fan 68 [0060]) which comprises a cooling air inlet (fig. 4, 44-I [0060]) and a cooling air outlet (fig. 4, 44-O [0060]), a cooling air path being configured and formed between the cooling air inlet and the cooling air outlet (fig. 4, 44-I and 44-O are fluidly connected as a path that cools heat generating internal components [0060]), and wherein the appliance inlet is arranged in the housing in a manner spaced apart from the cooling air outlet in such a wat that no air is aspirated through the appliance inlet to the cooling air outlet (fig. 4 shows the bottom of the appliance housing [0061] where 44-O is positioned [0060]; expiration air inlet 14 is shown on the front of the ventilator [0054]; [0049] expiratory port is connected to a tube [0049] to receive expired gas from the patient [0054], and thus the appliance inlet does not receive any air from the cooling outlet).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify DeVries to include a cooling unit as claimed, as taught by Taylor, in order to provide a cooling means to dissipate heat from internal components (Taylor [0060]).
Regarding Claim 5, DeVries discloses a respiratory device of claim 1, but is silent on wherein the bottom wall of the housing is detachable, and the pneumatic conveying line is removable in one piece via an opening of the bottom wall.
However, Taylor teaches a similar ventilator with a housing (fig. 1, 12 [0049]) that has a detachable bottom wall (fig. 6a, 22 [0049]; screw bosses 174 that couple to the upper housing 21 [0056]), and a pneumatic conveying line that is removable in one piece ([0016] the pneumatic block is removable; fig. 13, pneumatic block 56 is enclosed in a housing including main chassis 184, bottom lid 186 and top lid 182 [0083]) via an opening of the bottom wall (fig. 5b, fig. 5b, pneumatic block mounting seat 58 [0063] is accessible to remove the pneumatic block 56 when the bottom wall 22 is removed to open the housing 12 [0063]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify DeVries to have a detachable bottom wall of the housing, and to make the pneumatic conveying line removable in one piece, as taught by Taylor, in order to simplify servicing by making the entire pneumatic block replaceable and easily removed (Taylor [0083]).
Regarding Claim 6, DeVries discloses a respiratory device of claim 1, wherein the pneumatic conveying line comprises at least two sound units (fig. 13A, two perforated muffler tubes 1305 and 1306 [0144]), but is silent on at least one sound unit being arranged on a suction side of the pneumatic conveying line and one sound unit being arranged on a pressure side of the pneumatic conveying line.
However, Taylor teaches the use of at least two sound units (fig. 8, inlet muffler 39 and outlet muffler 84 [0063]), at least one sound unit being arranged on a suction side of the pneumatic conveying line (“suction side” is interpreted to mean the air intake side based on original specification page 20, lines 26-28; fig. 8, inlet muffler 39 is at the air intake side of pneumatic block 56 [0063]) and one sound unit being arranged on a pressure side of the pneumatic conveying line (fig. 8, outlet muffler 84 is positioned at the outlet flow of pressure from 56 [0063]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to place an additional muffler at the suction side of DeVries’ blower to reduce noise of air intake, since DeVries uses a muffler to reduce noise ([0142]) and Taylor teaches using a muffler at both a suction side and a pressure side (fig 8).
Regarding Claim 7, DeVries as modified by Taylor discloses a respiratory device of claim 4, but is silent on wherein the cooling air path is designed and configured in an opposite direction to and independent of the respiratory gas path of the pneumatic conveying line (fig. 4, the cooling path goes from 44-1 to 44-O [0060]; fig. 8, the direction of the flow moves from air flow path 35 at filter 37 to inspiration air outlet port 16 [0063]; see also fig. 3, filter assembly at 36 is located on the back of the housing 12 [0059]).
However, it has been held that a reversal of parts is an obvious modification (see MPEP 20144.04(VI)(a)), In re Gazda, 219 F.2d 449, 104 USPQ 400 (CCPA 1955) (Prior art disclosed a clock fixed to the stationary steering wheel column of an automobile while the gear for winding the clock moves with steering wheel; mere reversal of such movement, so the clock moves with wheel, was held to be an obvious modification.). In this case, reversing the direction of the cooling path so that the outlet becomes the inlet and vice versa would not affect the cooling function of the internal components.
Regarding Claim 9, DeVries discloses a respiratory device of claim 1, but is silent on wherein the device further comprises a receptacle for a quick-change adapter and comprises a quick-change adapter which is connected to a support frame via a rotary element, the quick-change adapter being configured to be pivotable in the receptacle from a first position to a second position via a rotation axis of the rotary element, the quick-change adapter in the second position being pivoted out from the receptacle such that in the second position a receptacle for an O₂ cartridge is accessible and an O₂ cartridge can be inserted, and wherein the quick-change adapter can then be pivoted back into the receptacle, together with the O₂ cartridge, to the first position (oxygen can be supplied via oxygen inlet port 308, fig. 3 [0049], but this is represented schematically and details of the construction are not shown).
Taylor teaches a ventilator that supplements oxygen via a receptacle (fig. 3, 46 [0060]) for a quick-change adapter ([0066] AFNOR is a quick change adaptor) and comprises a quick-change adapter which is connected to a support frame (fig. 3, support frame is the side wall of the ventilator) via a rotary element (AFNOR connectors use rotation for connection), the quick-change adapter being configured to be pivotable in the receptacle from a first position to a second position via a rotation axis of the rotary element (this is inherent in the AFNOR connector as the connector is threaded into the receptacle), the quick-change adapter in the second position being pivoted out from the receptacle such that in the second position a receptacle for an O₂ cartridge is accessible and an O₂ cartridge can be inserted (this is inherent in how AFNOR connectors operate, as the connector is threaded out of the receptacle), and wherein the quick-change adapter can then be pivoted back into the receptacle, together with the O₂ cartridge, to the first position (this is inherent in the operation of AFNOR connectors, when it is threaded into the receptacle).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the oxygen connector taught by Taylor at DeVries’ oxygen inlet port, since Taylor teaches an industry standard connector (AFNOR) to connect oxygen.
Claim 8 is rejected under 35 U.S.C. 103 as unpatentable over DeVries and Huster, further in view of Hicken et al. (EP 1408313 A2), hereafter Hicken. A machine translation is relied upon to address claims.
Regarding Claim 8, DeVries discloses a respiratory device of claim 1, wherein the pneumatic unit further comprises a flow measurement path (fig. 3, 325, 327 to 328 [0050]) which comprises at least one flow measuring unit (fig. 3, flow sensor at 325 [0050]) and is configured to detect at least one parameter of a respiratory gas in the flow measurement path (325 detects flow), but is silent on the flow measurement path being designed and configured linearly, a lattice mesh being arranged at a start and/or at an end of the flow measurement path, and being designed to be removable and reconditionable.
Hicken teaches the use of a flow measurement path (fig. 4, 28 [0039]) and a flow measuring unit (fig. 2, 14 [0034]) for a ventilator (fig. 1, [0031]) where the flow measurement path is linear (figs. 2 and 4) as well as the use of a lattice mesh (fig. 6, 27 [0039]) inserted into at the start and the end of the flow measurement path (guide 22 fig. 4 [0039]). This linear path and lattice mesh are used to make the flow more uniform in the region of the sensor ([0020]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make DeVries’ flow measurement path according to Hicken’s teaching in order to make the flow more uniform in the region of the flow sensor to improve the accuracy of the flow detection reading (Hicken [0006]).
While the modified device remains silent on the flow measurement path being removeable and reconditionable, it would have been obvious to one of ordinary skill in the art to make the modified flow measurement path separable, since it has been held that making parts separable is an obvious modification (see MPEP 2144.04(V)(C) In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961)). It further would have been obvious to make the flow measuring path reconditionable in order to provide cost savings as opposed to a full replacement of the flow measuring path.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARA K. TOICH whose telephone number is (703)756-1450. The examiner can normally be reached M-Th 7:30 am - 4:30 pm, every other F 7:30-3:30 ET.
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/SARA K TOICH/Examiner, Art Unit 3785
/VICTORIA MURPHY/Primary Patent Examiner, Art Unit 3785
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