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 . 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.
Response to Amendment
This Office Action is responsive to the amendment filed 01/26/2026 (“Amendment”). Claims 1, 2, 4-12, 14, and 15 are currently under consideration. The Office acknowledges the amendments to claims 1, 4, 8, 9, and 14, as well as the cancellation of claim 3. Claim 13 remains withdrawn.
The objection(s) to the drawings, specification, and/or claims, the interpretation(s) under 35 USC 112(f), and/or the rejection(s) under 35 USC 101 and/or 35 USC 112 not reproduced below has/have been withdrawn in view of the corresponding amendments.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: use of the word “cam” instead of “protrusion.”
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(s) is/are: “lung function diagnostics device” in claims 1, 14, and 15.
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 (e.g. for “lung function diagnostics device,” an ultrasonic spirometer as described in ¶ 0009 of the specification as filed).
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 § 103
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.
Claims 1, 2, 4-6, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication 2016/0045138 (“Eschenbacher”) in view of US Patent 11,253,670 (“Parazynski”).
Regarding claim 1, Eschenbacher teaches [a] breathing tube arrangement for a lung function diagnostics device, comprising a breathing tube defining a guiding path for breathing air to be analyzed by a lung function diagnostics device (Fig. 1, e.g. path 2 through the tubing, with analysis via sensors 8 and 9), the breathing tube having a proximal end (Fig. 1, at inlet opening 5), a distal end (Fig. 1, the outlet leading to diffuser 21) and an analysis zone located between the proximal end and the distal end (Fig. 1, e.g. at sensors 8 and 9), wherein the proximal end is designed to face a subject whose lung function is to be analyzed and to receive exhaled breathing air from the subject (Fig. 1, as shown), wherein the analysis zone serves for allowing an analysis of breathing air flowing through the breathing tube (¶ 0044, via the sensors), and wherein the distal end serves for releasing analyzed breathing air to an environment of the breathing tube (Fig. 1, as shown), wherein the breathing tube arrangement comprises a filter element having a filter material (Fig. 1, filter element 22, ¶ 0040), a breathing air releasing region (Fig. 1, at the outlet of diffuser 21) …, and a diffusor zone arranged proximally of the filter material (Fig. 1, diffuser 21), wherein the diffusor zone comprises a proximal end having a first proximal cross-sectional area and a distal end having a first distal cross-sectional area that is bigger than the first proximal cross-sectional area (Fig. 1, the inlet end of diffuser 21 and the end of the ramp portion of diffuser 21), wherein the proximal end of the diffusor zone is connected to the distal end of the breathing tube such that breathing air flowing from the breathing tube through the distal end of the breathing tube towards an environment of the breathing tube has to pass the filter element (Fig. 1, as shown), wherein the breathing air releasing region has a second distal cross-sectional area, wherein the second distal cross-sectional area is bigger than the first proximal cross-sectional area and at least as big as the first distal cross-sectional area (Fig. 1, the outer-most end of diffuser 21), wherein a ratio between the first proximal cross-sectional area and the second distal cross-sectional area lies in a range from 1:2 to 1:20 (Fig. 1, the outer-most end of diffuser 21 being at least twice the size of the inlet), and wherein the diffusor zone has sidewalls that diverge in a direction from the proximal end of the diffusor zone towards the distal end of the diffusor zone at least in a section between the proximal end of the diffusor zone and the distal end of the diffusor zone at an angle lying in a range of from 5° to 30° (Fig. 1, showing a similar angle. This angle is a known results-effective variable because it can be changed as desired to achieve particular flow properties. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to choose an angle between 5° to 30°, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges through routine experimentation is not inventive. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)).
Eschenbacher does not appear to explicitly teach the breathing air releasing region arranged distally of the filter material.
Parazynski teaches a breathing tube arrangement that has a filter element (Fig. 11, filter 370), a breathing air releasing region distal of the filter element (Fig. 11, at the left end), and a diffuser zone proximal of the filter element (Fig. 11, e.g. the increasing cross-sectional area leading to filter 370 from the right – also see col. 8, lines 46-67, describing elements to diffuse fluid particles), wherein the diffuser zone has a proximal cross-sectional area and a first distal cross-sectional area (Fig. 11, the changes in cross-section in that region), wherein the breathing air releasing region has a second distal cross-sectional area that is bigger than the proximal cross-sectional area and at least as big as the first distal cross-sectional area (Fig. 11, the area immediately to the left of filter 370 is at least as big as the area immediately to the right of filter 370). Parazynski also teaches the angle of a diffusor zone being similar to the range from 5° to 30° (Figs. 11, 28, etc.).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a breathing air releasing region like the one of Parazynski in Eschenbacher (an appropriately-sized region arranged distally of the filter), as the simple substitution of one air outlet arrangement for another with predictable results (filtering and releasing air in a manner that prevents expelling contagions – Parazynski: col. 1, lines 31-37). It would have been obvious to configure the diffusor zone of Eschenbacher with the angle claimed, as further supported by Parazynski, as already noted above.
Regarding claim 2, Eschenbacher-Parazynski teaches all the features with respect to claim 1, as outlined above. Eschenbacher-Parazynski further teaches wherein a distal end of the breathing air releasing region does not comprise a connector for connecting further elements of a breathing gas flow path to the breathing air releasing region (Eschenbacher: Fig. 1; Parazynski: Figs. 9, 11, etc.).
Regarding claim 4, Eschenbacher-Parazynski teaches all the features with respect to claim 1, as outlined above. Eschenbacher-Parazynski further teaches wherein the filter material is arranged in a filter material support (Eschenbacher: Fig. 1, as shown; Parazynski: Figs. 9 and 11, as shown), wherein the filter material support and/or the filter material have a circular base area (Parazynski: Figs. 9 and 11, as shown) having a diameter lying in a range from 30 mm to 160 mm (Eschenbacher: ¶ 0031, the cross-sectional areas provided for the channel 13 are e.g. 100 mm2 to 600 mm2, which correspond to diameters of 11.28 mm to 27.64 mm, and the filter element 22 appears to be 2-3 times as large.
The diameter is a known results-effective variable because it can be changed as desired to achieve particular flow properties. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a diameter between 30 mm and 160 mm, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges through routine experimentation is not inventive. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)).
Regarding claim 5, Eschenbacher-Parazynski teaches all the features with respect to claim 1, as outlined above. Eschenbacher-Parazynski further teaches wherein the filter material is arranged in a filter material support, wherein the filter material support further comprises a plurality of ribs arranged distally of the filter material and keeping the filter material within the filter material support (Parazynski: the ribs shown in Figs. 4, 9, etc., which would have been obvious to use for the purpose of containing the filter while allowing air out).
Regarding claim 6, Eschenbacher-Parazynski teaches all the features with respect to claim 5, as outlined above. Eschenbacher-Parazynski further teaches wherein at least some ribs of the plurality of ribs lie upon corresponding fins, wherein the filter material is clamped between the ribs and the fins (Parazynski: as shown in e.g. Fig. 11, on the opposite side of filter 370 – also see Figs. 14-17, showing that the ribs and fins correspond to each other. These would have been obvious to use for the purpose of containing the filter while allowing air out).
Regarding claim 14, Eschenbacher-Parazynski teaches all the features with respect to claim 1, as outlined above. Eschenbacher-Parazynski further teaches [a] lung function diagnostics device (Eschenbacher: Title, ¶ 0003, etc.), wherein a breathing tube arrangement according to claim 1 (see above) is inserted into the lung function diagnostics device such that i) a sensor of the lung function diagnostics device is able to analyze breathing air flowing through an analysis zone of a breathing tube of the breathing tube arrangement (Eschenbacher: ¶ 0044, etc.), ii) a proximal end of the breathing tube is arranged proximally of the sensor (Eschenbacher: Fig. 1, as shown), and iii) a filter element of the breathing tube arrangement is arranged distally of the sensor (Eschenbacher: Fig. 1, as shown).
Claims 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Eschenbacher-Parazynski in view of US Patent Application Publication 2003/0120169 (“Jones”).
Regarding claim 7, Eschenbacher-Parazynski teaches all the features with respect to claim 4, as outlined above. Eschenbacher-Parazynski does not appear to explicitly teach wherein the filter material is clamped in the filter material support such that a circumferential edge area of the filter material is more proximally or more distally arranged than a central area of the filter material.
Jones teaches clamping a filter material in its support in a manner that arranges the circumferential edge area of the filter material proximally or distally (Figs. 5, 5A, and 5B show the circumferential edge area displaced e.g. distally by barb 68).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the clamping arrangement of Jones in the combination as the simple substitution of one know filter attachment arrangement for another with predictable results (Jones: ¶ 0045, holding the filter material securely).
Regarding claim 8, Eschenbacher-Parazynski-Jones teaches all the features with respect to claim 7, as outlined above. Eschenbacher-Parazynski-Jones further teaches wherein an angle between i) a first line intersecting a center of the central area of the filter material on a proximal surface of the filter material and a first support point on which a proximal surface of the circumferential edge area abuts a support surface of the filter material support and ii) a second line extending from the first support point through an axis running through the center of the central area of the filter material along a longitudinal extension direction of the breathing tube arrangement to a second support point on which the proximal surface of the circumferential edge area abuts the support surface of the filter material support lies in a range from 1° to 10° (a filter with any flex at all will have this angle, if not initially, then after a breath sample has passed through it, since at least 1° of displacement of the center would be observed in materials that are not e.g. metal (and even then, a metal mesh filter could experience similar displacement)).
Claim 8 is alternatively rejected under 35 U.S.C. 103 as being unpatentable over Eschenbacher-Parazynski-Jones in view of US Patent 4,679,573 (“Parnoff”).
Regarding claim 8, Eschenbacher-Parazynski-Jones teaches all the features with respect to claim 7, as outlined above. In an alternative interpretation, Eschenbacher-Parazynski-Jones does not explicitly teach wherein an angle between i) a first line intersecting a center of the central area of the filter material on a proximal surface of the filter material and a first support point on which a proximal surface of the circumferential edge area abuts a support surface of the filter material support and ii) a second line extending from the first support point through an axis running through the center of the central area of the filter material along a longitudinal extension direction of the breathing tube arrangement to a second support point on which the proximal surface of the circumferential edge area abuts the support surface of the filter material support lies in a range of from 1° to 10° (although it is maintained that a filter with any flex at all will have this angle, if not initially, then after a breath sample has pass through it, since at least 1° of displacement of the center would be achieved by materials that are not e.g. metal (and even then, a metal mesh filter could experience similar displacement)).
Parnoff teaches using a dome-shaped filter to reduce the tendency for liquid to accumulate (Fig. 3, filter 19, and related description).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a dome-shaped filter in the combination, as in Parnoff, for the purpose of reducing the tendency for liquid to accumulate on the filter (Parnoff: Fig. 3 and related description). The angle of the dome is a known results-effective variable because it can be changed as desired to achieve particular filtration and water accumulation properties. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use an angle that lies in a range of from 1° to 10°, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges through routine experimentation is not inventive. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Eschenbacher-Parazynski in view of US Patent 6,131,573 (“Brown”).
Regarding claim 9, Eschenbacher-Parazynski teaches all the features with respect to claim 4, as outlined above. Eschenbacher-Parazynski does not appear to explicitly teach wherein the filter material support comprises a filter material support body and a filter material support cover, wherein one of the filter material support body and the filter material support cover comprises at least one protrusion and the other of the filter material support body and the filter material support cover comprises at least one notch for receiving the at least one protrusion.
Brown teaches securing a filter using corresponding protrusions and notches of a support body and support cover (Figs. 3, 4, and 7, with the annular wall 52 being a protrusion and having a corresponding groove 46, best shown in Fig. 7).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the clamping arrangement of Brown in the combination, as the simple substitution of one know filter attachment arrangement for another with predictable results (Brown: col. 5, lines 11-29, holding the filter material securely).
Claims 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Eschenbacher-Parazynski in view of US Patent Application Publication 2020/0397340 (“Dweik”).
Regarding claims 10-12, Eschenbacher-Parazynski teaches all the features with respect to claim 4, as outlined above. Eschenbacher-Parazynski does not appear to explicitly teach wherein the filter material comprising a filtering layer comprising blended synthetic fibers, wherein the filter material comprises a filtering layer and a top layer laminated onto the filtering layer, wherein the top layer is a scrim layer.
Dweik teaches making a filter from a blend of synthetic fibers, and including a top scrim layer (¶ 0078).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a filter material like the one of Dweik in the combination, for the purpose of improving particle capture via electrostatic properties, and for providing mechanical support and a carrier (Dweik: ¶ 0078), as the simple substitution of one filter material for another with predictable results (Dweik: ¶¶s 0077 and 0078, filtering micro-particles), and for the purpose of filtering micro-particles (Dweik: ¶¶s 0077 and 0078 – thus achieving Parazynski’s aim of preventing expulsion of contagions – Parazynski: col. 1, lines 31-37).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Eschenbacher-Parazynski in view of US Patent Application Publication 2007/0191726 (“Harnoncourt”).
Regarding claim 15, Eschenbacher-Parazynski teaches all the features with respect to claim 14, as outlined above. Eschenbacher-Parazynski does not appear to explicitly teach wherein the sensor is an ultrasonic sensor.
Harnoncourt teaches using an ultrasonic sensor around a breathing tube (Fig. 1, ¶¶s 0029, 0030, 0033, etc.).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the sensor of Harnoncourt in the combination, e.g. by replacing the sensor 9 of Eschenbacher, as a simple substitution with predictable results (since they both measure flow rate/velocity), and to additionally incorporate its sensor for the purpose of being able to calculate molar mass (Harnoncourt: ¶ 0033).
Response to Arguments
Applicant’s arguments filed 01/26/2026 have been fully considered.
In response to the arguments regarding the interpretation under 35 USC 112(f), they are not persuasive. The test is whether the term or phrase would be understood by persons of ordinary skill in the art to have a sufficiently definite meaning as the name for structure. This is not the case with “lung function diagnostics device.” A respiratory medicine practitioner would not say “hand me that lung function diagnostics device,” or “hand me that pulmonary function testing equipment.” They would say “hand me that spirometer.” Further, the analysis above identifies an exemplary structure, but notes that equivalents are also contemplated. There is no inconsistency.
In response to the arguments regarding the rejections under 35 USC 103 (e.g. as pertaining to the old claim 3), they are not persuasive. The Office disagrees that its citations are vague. This is evidenced at least by Applicant’s own citations to the relevant portions of the prior art figures.
Further, the Office’s assertions of a “similar angle” are not factually incorrect (i.e., the angle is neither 120° nor 90°), as shown below:
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Applicant’s arguments and declaration are not persuasive for establishing criticality of the claimed 5° to 30° angle. Although they may be relevant for showing that e.g. an 8° angle at a specific location in a specific configuration of flow tube has a certain effect, this is not enough for the following reasons – (1) the claims do not require the angle/diffusion to be at the particular location, and do not require the particular breathing tube structure (e.g. with no constrictions, etc.); (2) the claims do not require the angle to be measured as shown in e.g. Applicant’s Fig. 1C (i.e., not based on the longitudinal axis); and (3) the declaration does not explain the criticality of the entire range, or why the endpoints 5° and 30° are relevant. For example, it is unclear that an angle of 30° performs much differently than an angle of 45°, 60°, etc., especially in practical use.
The above rejection does not require removing Eschenbacher’s flow generator. In fact, Eschenbacher uses a diffusor zone together with the flow generator, so the two are compatible. Parazynski does not teach away from the claimed invention because it does not say that its dual-passage design would be compromised by a diffusor zone. In fact, Parazynski has its own diffusor zone, which is arranged after the treatment passage 325 (Fig. 11, etc.).
Finally, Applicant’s cited non-patent publication Rennels, D. et al., “Chapter 11: Expansions,” Pipe Flow: A Practical and Comprehensive Guide, John Wiley & Sons, Inc., 1st Edition, 2012, 17 pages (“Rennels”) teaches the claimed angles (Figs. 11.3 and 11.4, Tables 11.2 and 11.3, etc.), as do different portions of Eschenbacher itself:
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All claims remain rejected in light of the prior art.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREY SHOSTAK whose telephone number is (408) 918-7617. The examiner can normally be reached Monday-Friday, 7am-3pm PT.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Robertson, can be reached at telephone number (571) 272-5001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREY SHOSTAK/Primary Examiner, Art Unit 3791