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 .
Status of Claims
Applicant' s arguments, filed 08/27/2025, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claims 12 and 14 continue to be withdrawn per applicant's election of restriction requirement filed on 03/24/2025.
Applicants have amended their claims, filed 08/27/2025.
Applicant has newly added claims 16 and 17 in the response filed on 08/27/2025, which have been acknowledged and entered.
Applicant canceled claim 13 in the response filed on 08/27/2025.
Claims 1-11 and 15-17 are the current claims hereby under examination.
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 pressure measuring component 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(s) is/are: “pressure measuring component” in claim 15.
Three Prong Analysis:
“component” has been interpreted as a generic placeholder for “means”
“capable of measuring the expiratory lung pressure” has been interpreted as functional language.
There is not sufficient structure recited in the claim to perform the aforementioned function. Therefore, “pressuring measuring component” is being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
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 1-11 and 15-17 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 claim recites “the respective first sides of the support frame” and “the respective second sides of the support frame”. It is unclear how there can be more than one first side and more than one second side of a single support frame. Examiner suggests amending the claim limitations to read “the respective first sides of the support frames” and “the respective second sides of the support frames”. The claim also recites “a pair of valve support bodies defined by one of the first or second body portions”. However, none of the figures show the pair of valve support bodies being defined by the second body portion. The claim states a filter medium is disposed between the first and second body portions. Therefore, the filter medium is being interpreted as a divider between the first and second body portions. As seen in figures 1a, 2a, 3, and 4, the valve support bodies are only defined by the first body portion because they only ever appear on the same side as the mouthpiece with relation to the filter medium. Due to the aforementioned reasons, claim 1 is rendered indefinite. Claims 2-11 are rejected due to their dependence on claim 1.
Regarding Claim 8, the claim recites the term “optionally”. It is unclear if the limitation following the term “optionally” is part of the claimed invention. Are the valves diaphragm check valves or are they not? The claim also recites the broad recitation “check valves”, and the claim also recites “diaphragm check valves” which is the narrower statement of the limitation. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Due to the aforementioned reasons, claim 8 is rendered indefinite. Claim 9 is rejected due to its dependence on claim 8.
Regarding Claim 9, the claim recites “the diaphragm check valves each have a circular cross-section… a diametric strut to which is secured a respective one of the diaphragm check valves”. There is lack of proper antecedent basis for “the diaphragm check valves”. When claim 8 is interpreted to be “the valves are check valves”, there is no antecedent basis for “the diaphragm check valves”. Therefore, claim 9 is rendered indefinite.
Regarding Claim 15, the claim limitation “pressure measuring component” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The disclosure is devoid of any structure that can perform the pressure measuring function. Therefore, claim 15 is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-7, 10, and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Acorn et al. (US Patent No. 5305762 – previously cited) hereinafter Acorn in view of DeVries et al. (US Patent Pub. No. 20190054268 – previously cited) hereinafter DeVries.
Regarding Claim 1, Acorn discloses a valve housing for use in an apparatus for measuring inspiratory and expiratory lung pressure (invention relates generally to pulmonary performance testing equipment (col. 1, lines 8-9)),
the valve housing comprising a first body portion which defines a mouthpiece (lower end 20 of the stem portion is arranged to receive a tubular mouthpiece (col. 3, lines 22-23); fig 1; Examiner notes that lower end of the stem portion can serve as a mouthpiece);
a second body portion coupled to the first body portion and which defines a port (the upper end 18 of the stem portion 14 is open to the ambient while the lower end 20 of the stem portion (col. 3, lines 20-22); fig 1; Examiner notes the upper end of the stem portion can serve as a port);
a pair of spaced apart valve support bodies defined by one of the first or second body portions (The right end 22 of the cross-piece portion of the cruciform patient valve 10 is designed to receive the stem portion of a demand valve therein. The left end 24 of the cross-piece portion 16 is coupled through suitable tubing to a sample chamber. (col. 3, lines 23-28); fig 1), wherein each valve support body defines an air flow conduit (fig 1; elements 22 and 25; Examiner notes that air flows in elements 22 and 24) that includes a support frame disposed within the air flow conduit (check valves each comprise an annulus 30 (col. 3, line 34); fig 4), the support frame having a first side and a second side (left/bottom side or right/top side of annulus 30 in fig 4);
and a pair of valves (first and second one-way check valves 26 and 28 (col. 3, lines 32-33); fig 1), wherein the valves are selectively secured to the respective first sides of the support frame or are secured to the respective second sides of the support frame (The flap 34 has an outer diameter which is greater than the diameter of the opening 32 is anchored to the annulus 30 at a single point, as at 36 in FIG. 2 (col. 3, lines 44-47); As can be seen from FIG. 1, the one-way check valves 26 and 28 are positioned within the cross piece member 16 so that the flaps 34 and 35 open relative to the opening 32 in the annulus 30 by swinging to the left when viewed in FIG. 1. (col. 3, lines 53-57); fig 4; Examiner notes that check valves can be secured to either the left/bottom side or right/top side of annulus 30),
wherein when the valves are secured to the first sides of the support frame (Examiner notes valves 26 and 28 are secured to the left/top side of annulus 30), they open to permit air to exit the valve housing via the air flow conduits, but close to prevent air being drawn into the valve housing from the external environment (As the patient exhales, the flap 34 associated with the one-way check valve 26 is forced opened by the pressure differential while that same pressure differential forces the flap 35 of the one-way check valve 28 to assume its gas-blocking relationship relative to the annulus 30 on which it is mounted. (col. 4, lines 26-31); Examiner notes the reference states “annulus 28”, however, the annulus corresponds to reference number 30 and reference number 28 corresponds to the check valve; fig 1; Examiner notes valve 26 opens to permit air to exit the valve housing through the left end 24 and valve 28 closes to prevent air from being drawn into the valve housing from the right end 22 during exhalation; Because of the negative pressure created by the patient's lungs, the flap 35 of the check valve 28 will open, allowing the carbon monoxide to flow through it and through the mouthpiece into the patient's lungs. At this time, however, the same negative pressure created by inhalation will cause the flap 34 of the check valve 26 to be drawn against the side wall surface of the annulus 30. (col. 4, lines 2-9); Examiner notes that valve 28 opens to permit air to exit the valve housing via lower end 20 into the lungs and valve 26 closes to prevent air from being drawn into the valve housing from the left end 24 during inhalation – it is further noted that the claims do not require both valves to open simultaneously so that both valves simultaneously permit air to exit the valve housing, and that they do not require both valves to close simultaneously so that both valves simultaneously prevent air from being drawn into the valve housing);
and when the valves are secured to the second sides of the support frame (Examiner notes valves 26 and 28 can be secured to the right/bottom side of annulus 30), they open to permit air to enter into the valve housing via the air flow conduits from an external environment, but close to prevent air within the housing from exiting the housing (As the patient exhales, the flap 34 associated with the one-way check valve 26 is forced opened by the pressure differential while that same pressure differential forces the flap 35 of the one-way check valve 28 to assume its gas-blocking relationship relative to the annulus 30 on which it is mounted. (col. 4, lines 26-31); Examiner notes the reference states “annulus 28”, however, the annulus corresponds to reference number 30 and reference number 28 corresponds to the check valve; fig 1; Examiner notes valve 26 opens to permit air to enter the valve housing through the open end 20 from the lungs and valve 28 closes to prevent air within the housing from exiting the housing via the right end 22 during exhalation; Because of the negative pressure created by the patient's lungs, the flap 35 of the check valve 28 will open, allowing the carbon monoxide to flow through it and through the mouthpiece into the patient's lungs. At this time, however, the same negative pressure created by inhalation will cause the flap 34 of the check valve 26 to be drawn against the side wall surface of the annulus 30. (col. 4, lines 2-9); Examiner notes that valve 28 opens to permit air to enter the valve housing via the right end 22 and valve 26 closes to prevent air within the housing from exiting the housing via the left end 24 during inhalation).
Acorn fails to disclose a filter medium disposed between the first and second body portions.
However, DeVries teaches a filter medium disposed between a first and second body portions (bacterial filter 176 may be positioned between the first end portion 172 and the flexible tube segment 178 [0127]; fig 2A). DeVries also teaches a filter would prevent bacterial contamination and prevent bacteria from entering other components of the system [0165].
Acorn and DeVries are considered analogous art to the present invention because both inventions are directed towards the same field of endeavor.
It would have been obvious to one having ordinary skill at the art at the time of the effective filing date to have modified the valve housing of Acorn such that it includes a filter disposed between the first and second body portions, as taught by DeVries, because it would help prevent contamination and prevent bacteria from entering components of the valve housing. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, A.).
Regarding Claim 2, Acorn in view of DeVries teaches the invention as discussed in claim 1. Acorn further discloses the first and second body portions each have a substantially circular cross-section (a tubular body 12 (col. 3, line 8); fig 1).
Regarding Claim 3, Acorn in view of DeVries teaches the invention as discussed in claim 2. Acorn further discloses the mouthpiece is arranged co-axially with the first body portion (lower end 20 of the stem portion is arranged to receive a tubular mouthpiece (col. 3, lines 22-23); fig 1) and the port is arranged co-axially with the second body portion (the upper end 18 of the stem portion 14 is open to the ambient while the lower end 20 of the stem portion (col. 3, lines 20-22); fig 1).
Regarding Claim 4, Acorn in view of DeVries teaches the invention as discussed in claim 3. Acorn further discloses the valve support bodies are arranged radially outwards from the mouthpiece or the port (includes a stem portion 14 and a cross-piece portion 16 intersecting at generally right angles (col. 3, lines 10-11); right end 22 of the cross-piece portion...left end 24 of the cross-piece portion 16 (col. 3, lines 23-27); fig 1).
Regarding Claim 5, Acorn in view of DeVries teaches the invention as discussed in claim 1. Acorn further discloses the second body portion is coupled to the first body portion via an air-tight coupling (a tubular body 12 (col. 3, line 8); Examiner notes that tubular body defines the first and second body portions and is one piece, therefore the portions are coupled via an air-tight coupling).
Regarding Claim 6, Acorn in view of DeVries teaches the invention as discussed in claim 5. Acorn further discloses the second body portion is adhered to the first body portion, is welded to the first body portion, or is moulded to the first body portion (a tubular body 12 which is molded from a thermoplastic elastomer (col. 3, lines 8-9)).
Regarding Claim 7, Acorn in view of DeVries teaches the invention as discussed in claim 6. Acorn in view of DeVries further teaches the first and second body portions together define a chamber having a longitudinal axis (a tubular body 12 (col. 3, line 8, Acorn); Examiner notes the vertical axis of the tubular body 12 is the longitudinal axis) and the filter medium extends perpendicular to the longitudinal axis of the chamber and covers the entirety of the cross-sectional area of the chamber (fig 2A, DeVries), wherein the longitudinal axis extends through an open distal end of the mouthpiece and the port of the second body portion (Examiner notes that the tubular body 12 includes the upper end 18 and lower end 20 and therefore, the longitudinal axis extends through those portions; fig 1 Acorn), and wherein the second body portion includes a frustoconical portion expanding from a cylindrical body portion about the longitudinal axis to the air-tight coupling (the section of tubular body directly below element 14B in fig 1 of Acorn; Examiner notes that the tubular body 12 is the air-tight coupling and the frustoconical portion expands from the stem 14B to the center of the tubular body 12).
Acorn in view of DeVries fails to teach the frustoconical portion terminating in a skirt positioned radially outwardly from the longitudinal axis to an extent greater than a radial position of the valves.
However, the purpose of the frustoconical portion terminating in a skirt positioned radially outwardly from the longitudinal axis to an extent greater than a radial position of the valves is to form an air-tight seal. The valve housing of Acorn is inherently air-tight because the tubular body defines both the first and second body portions and the tubular body is one piece. Therefore, there is no functional reason for the frustoconical portion of Acorn to terminate in a skirt positioned radially outwardly from the longitudinal axis to an extent greater than a radial position of the valves. As such, it would have been obvious to one having ordinary skill in the art at the time of the effective filing date to have modified the valve housing of Acorn in view of DeVries such that the frustoconical portion terminates in a skirt positioned radially outwardly from the longitudinal axis to an extent greater than a radial position of the valves. The change in form or shape, without any new or unexpected results, is an obvious engineering design. See In re Dailey, 149 USPQ 47 (CCPA 1966) (see MPEP § 2144.04).
Regarding Claim 10, Acorn in view of DeVries teaches the invention as discussed in claim 1. Acorn further discloses the first body portion defines both of the valve support bodies (a stem portion 14 and a cross-piece portion 16 intersecting at generally right angles (col. 3, lines 10-11); fig 1).
Regarding Claim 11, Acorn in view of DeVries teaches the invention as discussed in claim 10. Acorn further discloses the mouthpiece includes a tubular mouthpiece body (lower end 20 of the stem portion is arranged to receive a tubular mouthpiece (col. 3, lines 22-23); fig 1; Examiner notes that lower end of the stem portion can serve as a mouthpiece) and the valve support bodies are arranged on opposite sides of the mouthpiece body (fig 1).
Claim(s) 8 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Acorn (US Patent No. 5305762 – previously cited) in view of DeVries (US Patent Pub. No. 20190054268 – previously cited) as applied to claim 1 above, and further in view of Paul (US Patent No. 3929127 – previously cited).
Regarding Claim 8, Acorn in view of DeVries teaches the invention as discussed in claim 1. Acorn discloses the valves are check valves (first and second one-way check valves 26 and 28 (col. 3, lines 32-33)).
Acorn in view of DeVries fails to teach the valves are diaphragm check valves. Examiner notes that this limitation does not require a prior art search and Acorn in view of DeVries teaches the limitations of claim 8, as the claim states “optionally” and it is unclear whether the limitation following “optionally” is part of the claim.
However, Paul teaches diaphragm check valves can be used in place of check valves (if diaphragm check valves are used (col. 5, lines 20-21)).
Paul is considered analogous art to the present invention because it is directed towards the same field of endeavor and reasonably pertinent to a problem faced by the inventors.
It would have been obvious to one having ordinary skill at the art at the time of the effective filing date to have modified the valve housing of Acorn in view of DeVries such that the check valves are diaphragm check vales, as taught by Paul. The simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, B.).
Regarding Claim 9, Acorn in view of DeVries teaches the invention as discussed in claim 8. Acorn in view of DeVries and further in view of Paul also teaches the diaphragm check valves each have a circular cross-section (figs 2 & 3, Acorn; fig 6, Paul); the valve support bodies each have a circular cross-section (tubular cross-piece portion 16 (col. 3, line 13, Acorn); and each support frame includes a diametric strut to which is secured a respective one of the diaphragm check valves (fig 6, Paul).
Claim(s) 15-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Acorn (US Patent No. 5305762 – previously cited) in view of DeVries (US Patent Pub. No. 20190054268 – previously cited) as applied to claim 1 above, and further in view Huhn (US Patent No. 5119825) and Schuelke et al. (US Patent Pub. No. 20170273597 – previously cited) herein after Schuelke.
Regarding Claim 15, Acorn in view of DeVries teaches a method of measuring expiratory lung pressure of a patient (invention relates generally to pulmonary performance testing equipment (col. 1, lines 8-9, Acorn)), the method comprising providing an apparatus as defined in Claim 1 (see claim 1 rejection above); the patient inhaling through the mouthpiece (patient is asked to breathe normally through the mouthpiece connected to the end 20 of the stem 14 (col. 3, lines 60-61, Acorn)), wherein one of the valves opens and permits air to enter the patient's lungs via the valve housing (Because of the negative pressure created by the patient's lungs, the flap 35 of the check valve 28 will open, allowing the carbon monoxide to flow through it and through the mouthpiece into the patient's lungs. At this time, however, the same negative pressure created by inhalation will cause the flap 34 of the check valve 26 to be drawn against the side wall surface of the annulus 30. (col. 4, lines 2-9); Examiner notes that valve 28 opens to permit air to exit the valve housing via lower end 20 into the lungs during inhalation); and the patient exerting an expiratory action, wherein one of the valves closes to permit expiratory air to exit the apparatus through the port (As the patient exhales, the flap 34 associated with the one-way check valve 26 is forced opened by the pressure differential while that same pressure differential forces the flap 35 of the one-way check valve 28 to assume its gas-blocking relationship relative to the annulus 30 on which it is mounted. (col. 4, lines 26-31); Examiner notes the reference states “annulus 28”, however, the annulus corresponds to reference number 30 and reference number 28 corresponds to the check valve; fig 1; Examiner notes valve 28 closes to permit expiratory air to exit the apparatus through the upper end 18 or the left end 24 during exhalation).
Acorn in view of DeVries fails to teach both of the valves open and permit air to enter the patient's lungs via the valve housing during inhalation and both of the valves close to permit expiratory air to exit the apparatus through the port to a pressure measuring component capable of measuring the expiratory pressure.
However, Acorn discloses the valve housing used in pulmonary performance testing can have multiple demand valves (demand valves incorporated into the disposable patient valve each comprise a rigid annular ring having a gas impervious flap affixed to a side surface thereof at a single hinge point (col. 2, lines 36-39)). Huhn teaches supplying oxygen and a carbon monoxide containing mixture through a demand valve during a cardiopulmonary test (to perform a nitrogen washout test to assess lung volume (col. 5, lines 26-27)… pure oxygen is made to enter the patient's lungs through line 28 and the demand valve 26 (col. 5, lines 35-36)… patient is made to breathe pure oxygen for a sufficiently long time to completely eliminate all nitrogen from the lungs (col. 5, lines 38-41); the patient will be made to draw a carbon monoxide containing mixture from a gas supply (not shown) through the tube 28 and the demand valve 26 into the lungs (col. 5, lines 1-4)).
Huhn is considered analogous art to the present invention because it is directed towards the same field of endeavor.
It would have been obvious to one having ordinary skill in the art at the time of the effective filing date to have modified the valve housing of Acorn in view of DeVries such that there are two demand valves, one for supplying oxygen and one for supplying carbon monoxide, because Huhn teaches two different gases are used to test cardiopulmonary function. The mere duplication of parts (demand valve), without any new or unexpected results, is within the ambit of one of ordinary skill in the art. See In re Harza, 124 USPQ 378 (CCPA 1960) (see MPEP § 2144.04). Furthermore, it would be easier for a user/operator if there are two separate demand valves because it would eliminate the need to attach and remove the different gas supplies from a singular demand valve.
Acorn in view of DeVries, and further in view of Huhn teaches both of the valves open and permit air to enter the patient's lungs via the valve housing during inhalation and both of the valves close to permit expiratory air to exit the apparatus through the port. Examiner notes that “both of the valves” would be the two demand valves.
Acorn in view of DeVries, and further in view of Huhn fails to teach both of the valves close to permit expiratory air to exit the apparatus through the port to a pressure measuring component capable of measuring the expiratory pressure.
However, Schuelke teaches a conduit which fluidly couples the port of the valve housing to a pressure measuring component of the apparatus (A detection unit can comprise one or more sensors, e.g., flow sensors or ambient air sensors. [0071]; a cylindrical body can have a second end (135b) that faces 180 degrees from a face of a first end (135a). In some embodiments, a second end (135b) can be inserted into an interface comprised in a detection unit (130). [0092]).
Schuelke is considered analogous art to the present invention because it is directed towards the same field of endeavor.
It would have been obvious to one having ordinary skill in the art at the time of the effective filing date to have further modified the valve housing of Acorn in view of DeVries and further in view of Huhn such that a pressure measuring component capable of measuring the expiratory pressure is coupled to the port, as taught by Schuelke, because it would allow for a more comprehensive view of a user’s pulmonary health. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, A.).
Regarding Claim 16, Acorn in view of DeVries, in view of Huhn, and further in view of Schuelke teaches the invention as discussed above in claim 15. Acorn further discloses the first and second body portions together define a chamber having a longitudinal axis (a tubular body 12 (col. 3, line 8); Examiner notes the vertical axis of the tubular body 12 is the longitudinal axis) that extends through an open distal end of the mouthpiece and the port of the second body portion (Examiner notes that the tubular body 12 includes the upper end 18 and lower end 20 and therefore, the longitudinal axis extends through those portions; fig 1).
Regarding Claim 17, Acorn in view of DeVries, in view of Huhn, and further in view of Schuelke teaches the invention as discussed above in claim 16. Acorn further discloses the second body portion includes a frustoconical portion expanding from a cylindrical body portion about the longitudinal axis to a coupling between the first body portion and the second body portion (the section of tubular body directly below element 14B in fig 1 of Acorn; Examiner notes that the tubular body 12 is the air-tight coupling and the frustoconical portion expands from the stem 14B to the center of the tubular body 12).
Acorn in view of DeVries, in view of Huhn, and further in view of Schuelke fails to teach the frustoconical portion terminating in a skirt positioned radially outwardly from the longitudinal axis to an extent greater than a radial position of the valves.
However, the purpose of the frustoconical portion terminating in a skirt positioned radially outwardly from the longitudinal axis to an extent greater than a radial position of the valves is to form an air-tight seal. The valve housing of Acorn is inherently air-tight because the tubular body defines both the first and second body portions and the tubular body is one piece. It would have been obvious to one having ordinary skill in the art at the time of the effective filing date to have modified the valve housing of Acorn in view of DeVries, in view of Huhn, and further in view of Schuelke such that the frustoconical portion terminates in a skirt positioned radially outwardly from the longitudinal axis to an extent greater than a radial position of the valves. The change in form or shape, without any new or unexpected results, is an obvious engineering design. See In re Dailey, 149 USPQ 47 (CCPA 1966) (see MPEP § 2144.04).
Response to Arguments
Applicant’s arguments, see page 8 of Remarks, filed 08/27/2025, with respect to drawing objections have been fully considered and are partially persuasive. The objection to drawings with regards to the air flow conduit has been withdrawn. However, Applicant has failed to address the drawing objection with regards to the pressure measuring component. Therefore, the drawing objection has been maintained and reiterated.
Applicant’s arguments, see page 8 of Remarks, filed 08/27/2025, with respect to specification objections have been fully considered and are persuasive. The specification objections have been withdrawn.
Applicant’s arguments, see pages 8-9 of Remarks, filed 08/27/2025, with respect to the rejection(s) of claim(s) 15 under 35 U.S.C. 112(a) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn.
Applicant’s arguments, see page 9 of Remarks, filed 08/27/2025, with respect to the rejection(s) of claim(s) 1 under 35 U.S.C. 112(b) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made.
Applicant’s arguments, see page 9 of Remarks, filed 08/27/2025, with respect to the rejection(s) of claim(s) 2-11 regarding the recitation of “a valve housing” under 35 U.S.C. 112(b) have been fully considered and are persuasive. Therefore, the rejections have been withdrawn. However, upon further consideration, a new ground(s) of rejection are made due to claims 2-11 being dependent on claim 1.
Applicant’s arguments, see page 9 of Remarks, filed 08/27/2025, with respect to the rejection(s) of claim(s) 2 regarding the term “generally” under 35 U.S.C. 112(b) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection are made due to claim 2 being dependent on claim 1.
Applicant's arguments, see page 9 of Remarks, filed 08/27/2025, with respect to the rejection(s) of claim(s) 8 regarding the term “optionally” under 35 U.S.C. 112(b) have been fully considered but they are not persuasive. Applicant argues the term “optionally” does not give rise to any ambiguity and cites the MPEP with regards to Markush groups. However, claim 8 is not constructed in the manner of a Markush group. Markush groups are a list of alternatives. Claim 8 recites a broad and narrow limitation with regards to the type of valve. Claim 8 is still indefinite because it is unclear if the valves have to be diaphragm check valves. Furthermore, claim 9 provides evidence of the ambiguity that arises by use of the term “optionally” in claim 8; claim 9 provides a further limitation to the “optional” diaphragm check valves. Claim 8 indicates that the diaphragm check valves are optional, whereas claim 9 indicates that they are required. Therefore, the 35 U.S.C. 112(b) rejection of claim 8 is maintained and updated.
Applicant’s arguments, see page 10 of Remarks, filed 08/27/2025, with respect to the rejection(s) of claim(s) 10 under 35 U.S.C. 112(b) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection are made due to claim 10 being dependent on claim 1.
Applicant’s arguments, see page 10 of Remarks, filed 08/27/2025, with respect to the rejection(s) of claim(s) 15 under 35 U.S.C. 112(b) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection are made due to the amendment of claim 15 including “pressure measuring component” which is interpreted under 35 U.S.C. 112(f).
Applicant’s arguments, see pages 10-12 of Remarks, filed 08/27/2025, with respect to the rejection(s) of claim(s) 1-11 and 15 under 35 U.S.C. 103 have been fully considered and are moot in view of the new grounds of rejections.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JANKI M BAVA whose telephone number is (571)272-0416. The examiner can normally be reached Monday-Friday 9:00-6:00 ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jason Sims can be reached at 571-272-7540. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JANKI M BAVA/Examiner, Art Unit 3791
/ETSUB D BERHANU/Primary Examiner, Art Unit 3791