DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
This office action is in response to the amendment filed 12/22/2025. As directed by the amendment, claim 14 has been amended, and claim 18 has been cancelled. As such, claims 14-16 and 19-26 are pending in the instant application.
Applicant has amended claim 14 to remove new matter; the rejection of the claims under 35 USC 112(a)/first paragraph is withdrawn.
Response to Arguments
Applicant’s arguments with respect to claim(s) 14 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 14-16 and 21-26 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 14 (and thus its dependent claims 15, 16 and 21-26), the meanings and scopes of “an extended light source configured to fit a cross-section of the measurement volume” and the light detecting element comprising “an extension configured to fit to a cross-section of the light source” are indefinite. What does it mean for a light source to be “extended”? Does this mean that light is configured to be emitted over/along some distance/length of an elongated shape, or that the light source protrudes (“extends”) axially and/or into the volume, or perhaps a wide (“extended”) range of wavelengths is emitted? Similarly, what does it mean for a light detecting element to comprise an extension? Does the extension itself provide light detection or is it e.g. a mounting component? And what does it mean to “fit to a cross-section” of something? Does “fit to” mean “surround, encompass, follow/extend along and/or have the same shape as (the entire or just a portion of) a perimeter of the cross-section,” or does it mean “attach to,” or something else? And is the cross-section a (central or off-center) longitudinal/parallel-to-flow-in-the-volume cross-section, lateral/perpendicular-to-flow-in-the-volume cross-section or some other cross-section? The specification as originally filed contains no additional language or description regarding these limitations, other than to indicate that rings are a species that meet the language (instant Fig. 3 and page 10, lines 9-29). For purposes examination, any light source and detecting element that have the same elongated shape and extend along at least part of a perimeter of any cross-section of a measurement volume will be considered to read on the instant limitations.
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: “adaptive structure” and “evaluation unit” in claims 14, 19 and 22.
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. An “adaptive structure” is understood, e.g. per instant claim 16 and instant Fig. 2, to be a ring/tubular construction that allows for detachment, and an “evaluation unit” is understood, per instant page 11, lines 31-36, to be an integrated circuit/computer.
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
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.
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) 14-16 and 22-24 are rejected under 35 U.S.C. 103 as being unpatentable over Dahlbäck et al. (US 5,887,586; hereinafter “Dahlbäck”) in view of Mace et al. (US 7,335,164 B2; hereinafter “Mace”) and Cao et al. (CN 106596364 A; hereinafter “Cao”; wherein the citations below refer to the translation provided with this Office Action) (with claim 14 as evidenced by the Casella AMS 950 manual, which is the sensor disclosed for use by Dahlbäck col. 2, lines 56-59; hereinafter “the Casella manual”).
Regarding claim 14, Dahlbäck discloses a sensor module (measurement section) (Fig. 2; col. 2, lines 51-55) for determining an aerosol dose rate of an aerosol stream (col. 4, lines 26-36), wherein the aerosol stream is provided to a patient by an inhalation device (comprising removable nose mask 21) (Fig. 2; abstract), wherein the sensor module comprises:
a tube (visible to the right of restriction 45 in Fig. 2) which is configured to attach the sensor module to the inhalation device (removable nose mask 21) (Fig. 2; col. 2, lines 14-17);
a measurement volume (the internal space of the measurement section) (Fig. 2);
a concentration measurement unit (measuring probe 41) configured to generate at least one first measurement signal depending on a concentration of the aerosol within the measurement volume (measured particle concentration/sampled light value) (col. 2, lines 56-63; col. 4, lines 11-14);
a flow measurement unit (air flowmeter45/46) which is designed for generating at least one second measurement signal depending on a flow of the aerosol stream through the measurement volume (flow rate value) (col. 3, lines 5-10; col. 4, lines 15-18),
wherein the flow measurement unit compromises a pressure measurement unit (pressure transducer 46) (col. 3, lines 5-10; col. 4, lines 15-18),
wherein the pressure measurement unit comprises a differential pressure sensor (pressure transducer 46) (col. 3, lines 5-10; col. 4, lines 15-18),
wherein a first port (at left/bottom tube 47) of the differential pressure sensor is configured for determining a first pressure in front of a flow constriction structure (comprised by airflow restriction 45) comprised within the measurement volume (Fig. 2; col. 3, lines 5-10; col. 4, lines 15-18), and
wherein a second port (at right/top tube 47) of the differential pressure sensor is designated for determining a second pressure after the flow constriction structure (Fig. 2; col. 3, lines 5-10; col. 4, lines 15-18),
wherein the differential pressure sensor is configured for generating the at least one second measurement signal from a difference between the first pressure and the second pressure (col. 3, lines 5-10; col. 4, lines 15-18); and
an evaluation unit (computer 52) configured to determine the aerosol dose rate in the inhalation device based on a contemporaneous determination of an aerosol concentration from the at least one first measurement signal and an inhalation flow from the at least one second measurement signal (col. 4, lines 26-36),
wherein the concentration measurement unit comprises an optical measurement unit (measuring probe 41) (light scattering instrument, col. 2, lines 56-63; see also page 6 of the Casella manual),
wherein the optical measurement unit is configured to generate the at least one first measurement signal depending on an interaction of light with the aerosol within the measurement volume (light scattering, col. 2, lines 56-63; see also page 6 of the Casella manual),
wherein the optical measurement unit comprises at least one light source and at least one light detecting element (see page 6 of the Castella manual).
While Dahlbäck discloses that the mask 21 is removable (col. 2, line 16), Dahlbäck does not explicitly disclose an adaptive structure according to the instant specification being comprised by the sensor module. However, Mace demonstrates that it was well known in the respiratory sensor art before the effective filing date of the claimed invention for respiratory sensors to include an adaptive structure (e.g. tubular housing 46) (Fig. 4), which is a ring/tube and thus is an adaptive structure according to the instant specification. Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention for the sensor module of Dahlbäck to include an adaptive structure/standard tubular/ring connector as taught by Mace, in order to provide the predictable result of a standard means for connecting the measurement section to the mask of Dahlbäck.
Dahlbäck is silent regarding wherein the light source comprises an extended light source configured to fit to a cross-section of the measurement volume, and wherein the light detecting element comprises an extension configured to fit to a cross-section of the light source. However, Cao teaches that it was known in the concentration measurement art/to solve the problem of gas-entrained/atomized particle concentration determination before the effective filing date of the claimed invention to include, as best understood, wherein the light source (any of light sources 4-1 to 4-3) (Figs. 1-2) comprises an extended light source (the light sources are elongated rectangular shapes) configured to fit to a cross-section of the measurement volume (the light sources extend along the perimeter of a longitudinal cross-section of the volume of chamber 8 and are curved to “fit” it, see Figs. 1-2), and wherein the light detecting element (any of image collecting devices 5-1 to 5-3) comprises an extension configured to fit to a cross-section of the light source (the light detecting elements have the same extension and shapes as the light sources, see Figs. 1-2). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention to modify the optical measurement unit of Dahlbäck to include wherein the light source comprises an extended light source configured to fit to a cross-section of the measurement volume, and wherein the light detecting element comprises an extension configured to fit to a cross-section of the light source as taught by Cao, in order to provide the predictable result of an optical concentration detection unit that utilizes known structure (elongated elements arranged around and along a perimeter of the measurement volume) to provide the predictable result of comprehensive analysis of particle concentration by taking measurements from different directions (Cao page 3, third paragraph from the bottom).
Regarding claim 15, Dahlbäck in view of Mace and Cao teaches the sensor module of claim 14, wherein Dahlbäck further discloses wherein the measurement volume is or comprises a spatial area delimited by a circumference along an internal surface of the sensor module (Dahlbäck Fig. 2, and see also Mace Fig. 4, which depicts a well-known configuration for a combined differential pressure sensor/optical detector, which would have been obvious to an artisan before the effective filing date of the claimed invention to include in Dahlbäck in order to provide whole the measurement section as an easily removed/replaced/sterilizable section).
Regarding claim 16, Dahlbäck in view of Mace and Cao teaches the sensor module of claim 15, wherein Dahlbäck as modified by Mace teaches wherein the adaptive structure is an adaptor ring being tightly attachable to the inhalation device (Dahlbäck Fig. 2 in view of Mace Fig. 4, where a tight connection is reasonably inferred/would have been obvious to an artisan before the effective filing date of the claimed invention in order to avoid leakage/contamination of the surrounding area by aerosol).
Regarding claim 22, Dahlbäck in view of Mace and Cao teaches the sensor module of claim 14, wherein Dahlbäck further discloses wherein the evaluation unit is further configured to determine an inhaled dose per breath (the inhaled dose calculated for each inhalation, col. 5, lines 12-13) and a total inhaled dose per application (sum of all previously calculated inhaled partial doses, col. 4, lines 63-65) based on the determined aerosol dose rate in the inhalation device (col. 4, lines 26-65).
Regarding claim 23, Dahlbäck in view of Mace and Cao teaches an inhalation device (Dahlbäck Fig. 2 in view of Mace Fig. 4) for providing an aerosol stream to a patient (Dahlbäck abstract), wherein the inhalation device comprises:
a sensor module for determining an aerosol dose rate of an aerosol stream of claim 14, the sensor module comprising an adaptive structure configured to attach the sensor module to the inhalation device (see claim 14 discussion above);
an aerosol generator (aerosol generator 20) configured to generate the aerosol stream (Dahlbäck Fig. 2, col. 2, lines 15-26); and
a patient interface (mask 21) configured to provide of the aerosol stream to the patient (Dahlbäck Fig. 2, col. 2, lines 15-39).
Regarding claim 24, Dahlbäck in view of Mace and Cao teaches a method for determining an aerosol dose rate of an aerosol stream (Dahlbäck col. 4, lines 26-36), wherein the aerosol stream is provided to a patient by an inhalation device (comprising removable nose mask 21) (Dahlbäck Fig. 2; abstract), wherein the method comprises:
attaching the sensor module of claim 14 to the inhalation device (Dahlbäck Fig. 2 in view of Mace Fig. 4; see claim 14 discussion above), wherein the inhalation device is configured to provide the aerosol stream to a patient (Dahlbäck Fig. 2; col. 2, lines 15-39);
generating at least one first measurement signal depending on a concentration of the aerosol within the measurement volume comprised by the sensor module (measured particle concentration/sampled light value) (Dahlbäck Fig. 2; col. 2, lines 56-63; col. 4, lines 11-14; and see claim 14 discussion above regarding the substitution of one known optical concentration sensor arrangement/construction for another);
generating at least one second measurement signal depending on a flow of the aerosol stream through the measurement volume (flow rate value) (Dahlbäck Fig. 2; col. 3, lines 5-10; col. 4, lines 15-18); and
determining the aerosol dose rate in the inhalation device based on a contemporaneous determination of an aerosol concentration from the at least one first measurement signal and an inhalation flow from the at least one second measurement signal (Dahlbäck col. 4, lines 26-36).
Claim(s) 21 is rejected under 35 U.S.C. 103 as being unpatentable over Dahlbäck in view of Mace and Cao as applied to claim 14 above, and further in view of Kleven (US 6,311,568 B1; hereinafter “Kleven”).
Regarding claim 21, Dahlbäck in view of Mace and Cao teaches the sensor module of claim 14, but modified Dahlbäck is silent regarding wherein a first multitude of holes is provided along a circumference of the measurement volume in front of the flow constriction structure, wherein a second multitude of holes is provided along the circumference of the measurement volume after the flow constriction structure, wherein each multitude of holes is in fluid connection to a corresponding pressure measurement chamber, wherein each pressure measurement chamber is in fluid connection to a corresponding port of the differential pressure sensor.
However, Kleven demonstrates that it was well known in the differential pressure sensor art before the effective filing date of the claimed invention for a differential pressure sensor to include a first multitude of holes (plurality of openings 182 in ring 186-2) (Fig. 12A) provided along a circumference of the measurement volume in front of the flow constriction structure (flow interrupter 112) (Fig. 12A in view of e.g. Fig. 5),
wherein a second multitude of holes (plurality of openings 182 in ring 188-2) (Fig. 12A) is provided along the circumference of the measurement volume after the flow constriction structure (Fig. 12A in view of e.g. Fig. 5),
wherein each multitude of holes is in fluid connection to a corresponding pressure measurement chamber (annular pressure channels 174, 176) (Fig. 12A; col. 4, lines 40-44),
wherein each pressure measurement chamber is in fluid connection (via passageways 104, 106) to a corresponding port of the differential pressure sensor (process instrumentation 120 comprising pressor sensor module 122) (Figs. 1 and 12A; col. 2, lines 43-48 and col. 4, lines 40-44). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention for modified Dahlbäck to include wherein a first multitude of holes is provided along a circumference of the measurement volume in front of the flow constriction structure, wherein a second multitude of holes is provided along the circumference of the measurement volume after the flow constriction structure, wherein each multitude of holes is in fluid connection to a corresponding pressure measurement chamber, wherein each pressure measurement chamber is in fluid connection to a corresponding port of the differential pressure sensor as taught by Kleven, in order to provide the predictable result of a known differential pressure sensor arrangement/functional substitute, particularly one that provides multiple pressure-sensing holes so that even if one (or more) sensing hole is blocked, pressure readings can still be taken.
Claim(s) 25 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Dahlbäck in view of Mace and Cao as applied to claim 14 or 24 above, and further in view of Shofner, II et al. (US 2002/0033173 A1; hereinafter “Shofner II”).
Regarding claim 25, Dahlbäck in view of Mace and Cao teaches the method of claim 24, wherein Dahlbäck further discloses wherein the method further comprises: determining an inhaled dose per breath (inhaled dose calculated for each inhalation) by summing values for the aerosol dose rate over a single inhalation step from an initial time to a final time (col. 4, lines 26-36 and 63-65 in view of col. 5, lines 12-13), wherein, to determine the dose for a given breath, the timing of said breath would have to be known, but Dahlbäck is silent regarding integrating the aerosol dose rate over a single inhalation step from an initial time to a final time. However, Shofner II demonstrates that it was well known in the optical-sensor/differential-pressure-sensor aerosol detector art before the effective filing date of the claimed invention to calculate an amount of aerosol delivered within a given time frame by either summing or integrating the aerosol dose rate from an initial time to a final time (paras [0030] and [0045]). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention for the method of modified Dahlbäck to include integrating the aerosol dose rate over a single inhalation step from an initial time to a final time as taught by Shofner II, in order to provide the predictable result of a more accurate calculation of the dose delivered within a given inhalation.
Regarding claim 26, Dahlbäck in view of Mace, Cao and Shofner II teaches the method of claim 25, wherein modified Dahlbäck further teaches wherein the method further comprises: determining a total inhaled dose per application after having taken the n-th breath through the inhalation device by summing the inhaled doses per breath (sum of all previously calculated inhaled partial doses…when the maximal test duration has expired…the inhaled dose calculated for each inhalation, Dahlbäck col. 4, line 63-col. 5, line 13), because it would have been obvious to an artisan before the effective filing date of the claimed invention to calculate the dose for each inhalation and then multiply it by the number of inhalations taken to determine the dose delivered during a given session, as a standard means for calculating the amount of something delivered over variable finite periods.
Allowable Subject Matter
Claims 19 and 20 are allowed.
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 KATHRYN E DITMER whose telephone number is (571)270-5178. The examiner can normally be reached M 7:30a-3:30p, T/Th 8:30a-2:30p, W 11:30a-4:30p, F 1-4p ET.
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/KATHRYN E DITMER/Primary Examiner, Art Unit 3785