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
The present Office action is responsive to the application as filed on 01-24-2023, and the Preliminary amendments filed on 04-23-2023 and 04-24-2023. As directed, claims 2-39 are currently pending examination, after cancellation of claim 1, and addition of claims 21-29.
Specification
The use of the term “Bluetooth”, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology. Furthermore, the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claims 2-4, 6, 8, 10-12, 15, 17, 21, 24-25, 27, 29-32, and 35-38 are objected to because of the following informalities:
At claim 2, line 2, it is suggested that a colon be added at the end of the line.
At claim 2, line 5, it is suggested that “the” be added before “air outlet” for consistency.
At claim 2, line 13, it is suggested that “the” be added before “air flow speed” for clarity.
At claim 2, line 13, it is suggested that “the” be added before “pre-determined” for clarity.
At each of claims 3-20, it is suggested that “Claim” be replaced with “claim”.
At claim 3, line 2, it is suggested that “is formed” be replaced with “are formed” as two separate elements are referred to.
At claim 4, line 2, it is suggested that “the” be added before “air outlet” for consistency.
At claim 6, line 2 it is suggested that “the length” be replaced with “a length” as the limitation has not yet been introduced.
At claim 6, line 3 it is suggested that “the material thickness” be replaced with “a material thickness” as the limitation has not yet been introduced.
At claim 8, line 2, it is suggested that “the width” be replaced with “a width” as the limitation has not yet been introduced.
At claim 10, line 3, it is suggested that “least” be added after “of at” for clarity.
At claim 10, line 3, it is suggested that “the width” be replaced with “a width” as the limitation has not yet been introduced.
At claim 11, line 3, it is suggested that “the type” be replaced with “a type” as the limitation has not yet been introduced.
At claim 11, line 4, it is suggested that “gap(s)” be replaced with “the one or more gaps” for consistency.
At claim 11, line 4-5, it is suggested that “which can both be selected depending on the type of gap(s) selected and which specific sound is preferred” be replaced with “which are both configured to be selected depending on a type of the one or more gaps and a preferred sound to be output” for clarity.
At claim 12, line 2, it is suggested that “difference” be replaced with “different” for clarity.
At claim 15, line 3, it is suggested that “the relevant range” be replaced with “a relevant range” as the limitation has not yet been introduced.
At claim 17, line 3, it is suggested that “first” be added before “passive acoustic element” for clarity.
At claim 21, line 3, it is suggested that “first” be added before “passive acoustic element” for clarity.
At claim 24, line 4, it is suggested that “the gap” be replaced with “the one or more gaps” for consistency with line 2.
At claim 25, line 3, it is suggested that “and inhalable” be replaced with “an inhalable” for clarity.
At claim 27, line 5, it is suggested that “a user” be replaced with “the user” as the limitation is introduced at claim 2.
At claim 27, line 5, it is suggested that “the” be added before “air outlet” for consistency.
At claim 29, line 2, it is suggested that “is” be replaced with “are” as two elements are referred to.
At claim 30, it is suggested that “a flow path” be replaced with “the flow path” and “an air flow” be replaced with “the air flow” as both limitations are introduced in claim 2. Claim 30 is interpreted below to depend from claim 2.
At claim 31, it is suggested that “a flow path” be replaced with “the flow path” as the limitations is introduced in claim 2. Claim 31 is interpreted below to depend from claim 2.
At claim 32, it is suggested that “a flow path” be replaced with “the flow path” as the limitation is introduced in claim 2. Claim 32 is interpreted below to depend from claim 2.
At claim 35, line 3, it is suggested that “first” be eliminated for consistency.
At claim 36, line 2, it is suggested that “an” be replaced with “the” as the add-on of claim 2 has already been introduced.
At claim 36, lines 3, it is suggested that “any” be eliminated for clarity.
At claim 37, line 2, it is suggested that “an” be replaced with “the” as the add-on of claim 2 has already been introduced.
At claim 38, line 1, it is suggested that “an” be replaced with “the” as the add-on of claim 2 has already been introduced.
Appropriate correction is required.
Claim 29 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 28. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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 2-39 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 2, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claims 3-39 are rejected by virtue of their dependence, or assumed dependence, on claim 2.
Regarding claim 2, lines 9-10 recite “so as to allow acoustic monitoring of air flow passing the first passive acoustic element external to the housing” which renders the claim indefinite because line 6 states that the first passive acoustic element is “arranged in the flow path inside the housing”. Thus, it is unclear how air flow external to the housing is acoustically monitored, if the passive acoustic element is internal to the housing.
For the purposes of examination, the external air flow will be regarded as a user inhalation or exhalation originating outside of the housing.
Claims 3-39 are rejected by virtue of their dependence, or assumed dependence, on claim 2.
Regarding claim 2, line 12 recites “an air flow” which renders the claim indefinite because it is unclear if this air flow is the same as that introduced in line 7, or a new air flow. For the purposes of examination, the air flow will be interpreted as the same in line 7. Applicant should replace “an” with “the” to overcome the rejection.
Claims 3-39 are rejected by virtue of their dependence, or assumed dependence, on claim 2.
Claim 6 recites the limitation "the one or more gaps" in lines 2 and 3. There is insufficient antecedent basis for this limitation in the claim.
Applicant should amend the dependency of claim 6 to depend from claim 3 to overcome this rejection.
Claim 7 recites the limitation "the one or more gaps" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Applicant should amend the dependency of claim 7 to depend from claim 3 to overcome this rejection.
Regarding claim 7, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
For the purposes of examination, only one of the angle ranges will be required for the prior art to read on the claim.
Claim 8 recites the limitation "the one or more gaps" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Applicant should amend the dependency of claim 8 to depend from claim 3 to overcome this rejection.
Claim 9 is rejected by virtue of its dependence on claim 8.
Claim 11 recites the limitation "the one or more gaps" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Applicant should amend the dependency of claim 8 to depend from claim 3 to overcome this rejection.
Regarding claim 11, the phrase "can" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 16 recites the limitation "the inhaler medicament compartment" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 17 is rejected by virtue of its dependence on claim 16,
Regarding claim 17, line 3 recites “to allow the flow path around the passive acoustic element irrespective of an inhalation flow path” which renders the claim indefinite because it is unclear what the flow path is allowed to do or achieve.
For the purposes of examination, the claim will be interpreted such that the flow path around the passive acoustic element still exists irrespective of air flowing within wither of the split inlets.
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). In the present instance, claim 20 recites the broad recitation “better than 200 micrometers”, and the claim also recites “preferably better than 100 micrometers” which is the narrower statement of the range/limitation. 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.
Regarding claim 21, line 1 recites “device according to claim 1” which renders the claim indefinite as claim 1 has been canceled. Thus, it is unclear from which previous claim claim 21 is meant to depend from.
For the purposes of examination, claim 21 will be interpreted as depending from claim 3 since claim 21 includes recitation of “the one or more gaps” which are introduced in claim 3. The rejection may be overcome by amending the claim dependency as such.
Regarding claim 22, line 1 recites “device according to claim 1” which renders the claim indefinite as claim 1 has been canceled. Thus, it is unclear from which previous claim claim 22 is meant to depend from.
For the purposes of examination, claim 22 will be interpreted as depending from claim 3 since claim 22 includes recitation of “said one or more gaps” which are introduced in claim 3. The rejection may be overcome by amending the claim dependency as such.
Regarding claim 23, line 1 recites “device according to claim 1” which renders the claim indefinite as claim 1 has been canceled. Thus, it is unclear from which previous claim claim 23 is meant to depend from.
For the purposes of examination, claim 23 will be interpreted as depending from claim 2. The rejection may be overcome by amending the claim dependency as such.
Regarding claim 24, line 1 recites “device according to claim 1” which renders the claim indefinite as claim 1 has been canceled. Thus, it is unclear from which previous claim claim 24 is meant to depend from.
For the purposes of examination, claim 24 will be interpreted as depending from claim 2. The rejection may be overcome by amending the claim dependency as such.
Regarding claim 25, line 1 recites “device according to claim 1” which renders the claim indefinite as claim 1 has been canceled. Thus, it is unclear from which previous claim claim 25 is meant to depend from.
For the purposes of examination, claim 25 will be interpreted as depending from claim 2. The rejection may be overcome by amending the claim dependency as such.
Regarding claim 26, line 1 recites “device according to claim 1” which renders the claim indefinite as claim 1 has been canceled. Thus, it is unclear from which previous claim claim 26 is meant to depend from.
For the purposes of examination, claim 26 will be interpreted as depending from claim 2. The rejection may be overcome by amending the claim dependency as such.
Regarding claim 27, lines 9-10 recite “so as to allow acoustic monitoring of air flow passing the first passive acoustic element external to the housing” which renders the claim indefinite because line 6 of claim 1 states that the first passive acoustic element is “arranged in the flow path inside the housing”. Thus, it is unclear how air flow external to the housing is acoustically monitored, if the passive acoustic element is internal to the housing.
For the purposes of examination, the external air flow will be regarded as a user inhalation or exhalation originating outside of the housing.
Regarding claim 28, line 1 recites “device according to claim 1” which renders the claim indefinite as claim 1 has been canceled. Thus, it is unclear from which previous claim claim 28 is meant to depend from.
For the purposes of examination, claim 28 will be interpreted as depending from claim 2. The rejection may be overcome by amending the claim dependency as such.
Regarding claim 29, line 1 recites “device according to claim 1” which renders the claim indefinite as claim 1 has been canceled. Thus, it is unclear from which previous claim claim 29 is meant to depend from.
For the purposes of examination, claim 29 will be interpreted as depending from claim 2. The rejection may be overcome by amending the claim dependency as such.
Regarding claim 30, line 1 recites “device according to claim 1” which renders the claim indefinite as claim 1 has been canceled. Thus, it is unclear from which previous claim claim 30 is meant to depend from.
For the purposes of examination, claim 30 will be interpreted as depending from claim 2. The rejection may be overcome by amending the claim dependency as such.
Regarding claim 31, line 1 recites “device according to claim 1” which renders the claim indefinite as claim 1 has been canceled. Thus, it is unclear from which previous claim claim 31 is meant to depend from.
For the purposes of examination, claim 31 will be interpreted as depending from claim 2. The rejection may be overcome by amending the claim dependency as such.
Regarding claim 32, line 1 recites “device according to claim 1” which renders the claim indefinite as claim 1 has been canceled. Thus, it is unclear from which previous claim claim 32 is meant to depend from.
For the purposes of examination, claim 32 will be interpreted as depending from claim 2. The rejection may be overcome by amending the claim dependency as such.
Regarding claim 33, line 1 recites “device according to claim 1” which renders the claim indefinite as claim 1 has been canceled. Thus, it is unclear from which previous claim claim 33 is meant to depend from.
For the purposes of examination, claim 33 will be interpreted as depending from claim 2. The rejection may be overcome by amending the claim dependency as such.
Claim 35 is rejected by virtue of its dependence on claim 33.
Regarding claim 34, line 1 recites “device according to claim 1” which renders the claim indefinite as claim 1 has been canceled. Thus, it is unclear from which previous claim claim 34 is meant to depend from.
For the purposes of examination, claim 34 will be interpreted as depending from claim 2. The rejection may be overcome by amending the claim dependency as such.
Regarding claim 36, line 1 recites “device according to claim 1” which renders the claim indefinite as claim 1 has been canceled. Thus, it is unclear from which previous claim claim 36 is meant to depend from.
For the purposes of examination, claim 36 will be interpreted as depending from claim 2. The rejection may be overcome by amending the claim dependency as such.
Regarding claim 37, line 2 recites “device according to claim 1” which renders the claim indefinite as claim 1 has been canceled. Thus, it is unclear from which previous claim claim 37 is meant to depend from.
For the purposes of examination, claim 37 will be interpreted as depending from claim 2. The rejection may be overcome by amending the claim dependency as such.
Claim 39 is rejected by virtue of its dependence on claim 37.
Regarding claim 38, line 2 recites “device according to claim 1” which renders the claim indefinite as claim 1 has been canceled. Thus, it is unclear from which previous claim claim 38 is meant to depend from.
For the purposes of examination, claim 38 will be interpreted as depending from claim 2. The rejection may be overcome by amending the claim dependency as such.
Regarding claim 39, line 1 recites “the method according to claim 37” which renders the claim indefinite as claim 37 recites a system rather than a method.
For the purposes of examination, claim 39 will be interpreted as depending from claim 38 which recites a method. The rejection may be overcome by amending the claim dependency as such.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 2, 4, 7, 11-13, 16, 18, 21-27, and 30-32 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sharp (GB 2,299,512).
Regarding claim 2, Sharp discloses an inhaler add-on device (the combination of mouthpiece 40 and siren/sound indicating means comprising rotor 42, disc 50, and bearing 56) for add-on to an inhaler (inhaler with expansion chamber 10) for dispensing a medicament to be inhaled, (abstract, lines 1-3; page 7, lines 1-11; page 4, lines 22-28 through page 5, lines 1-3: the expansion chamber 10 is connected to an inhaler on one end and the mouthpiece on a second end, thereby connecting the mouthpiece 40 and the inhaler; Fig. 1), the inhaler add-on device (the combination of mouthpiece 40 and siren/sound indicating means comprising rotor 42, disc 50, and bearing 56) comprising:
a housing (exterior of mouthpiece 40 housing the internal components of the siren/sound indicating means) comprising an air inlet, and an air outlet (see annotated Fig. 1 below for the air inlet and the air outlet; page 7, lines 1-3; Fig. 1), such as comprising a mouthpiece (40) for outputting air to be inhaled by a user (page 3, lines 6-13; Fig. 1), wherein the housing (exterior of mouthpiece 40 housing the internal components of the siren/sound indicating means) defines a flow path between the air inlet and air outlet (page 8, lines 17-20; Fig. 1, see annotated version below for inlet and outlet), wherein the housing (exterior of mouthpiece 40 housing the internal components of the siren/sound indicating means) is configured for connection to the inhaler (inhaler with expansion chamber 10) (page 4, lines 22-28 through page 5, lines 1-3: the expansion chamber 10 is connected to an inhaler on one end and the mouthpiece on a second end, thereby connecting the mouthpiece 40 and the inhaler), and
a first passive acoustic element (comprisal of 42 and 50) arranged in the flow path inside the housing (exterior of mouthpiece 40 housing the internal components of the siren/sound indicating means) and dimensioned such that air flow passing the first passive acoustic element (comprisal of 42 and 50) will generate sound with pre-determined characteristics depending on flow speed of air passing the first passive acoustic element (comprisal of 42 and 50) (page 7, lines 20-27 through page 8, lines 1-4), so as to allow acoustic monitoring of air flow passing the first passive acoustic element (comprisal of 42 and 50) external to the housing (exterior of mouthpiece 40 housing the internal components of the siren/sound indicating means) (page 8, lines 1-4, note that the “external” air flow is interpreted as the user’s inhalation and/or exhalation),
wherein the first passive acoustic element (comprisal of 42 and 50) comprises a structure having one or more gaps (see each of 48 and 52 which are gaps in the identified passive acoustic element) arranged to be passed by the air flow (page 7, lines 17-27), and wherein the one or more gaps (see each of 48 and 52 which are gaps in the identified passive acoustic element) are shaped and separated by a distance so as to generate sound depending on air flow speed with pre-determined characteristics comprising at least spectral components (page 7, lines 20-27 through page 8, lines 1-4: each pitch of whistle, which is based on air flow speed, would contribute a spectral component based on its sound).
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Regarding claim 4, Sharp discloses the inhaler add-on device according to claim 2, as discussed above.
Sharp further discloses wherein the air outlet (see annotated Fig. 1 above) of the housing (exterior of mouthpiece 40 housing the internal components of the siren/sound indicating means) is arranged for connection to a separate device (10), wherein said separate device (10) comprises a compartment comprising a medicament to be inhaled (page 4, lines 21-27; page 9, lines 12-16; Fig. 1).
Regarding claim 7, Sharp discloses the inhaler add-on device according to claim 2, as discussed above.
Sharp further discloses wherein the one or more gaps (see each of 48 and 52 which are gaps in the identified passive acoustic element) have sharp edges, such as formed by 90-degree corners (see Fig., 1, where the edge of the gap 52 is formed of a 90-degree angle).
Regarding claim 11, Sharp discloses the inhaler add-on device according to claim 2, as discussed above.
Sharp further discloses wherein the first passive acoustic element (comprisal of 42 and 50) has surfaces in or adjacent the one or more gaps (see each of 48 and 52 which are gaps in the identified passive acoustic element) which have surface morphology and surface material, which can be selected depending on the type of gap and the specific sound preferred (page 7, lines 20-27 through page 8, lines 1-4: each pitch of whistle, which is based on air flow speed over the surface material and morphology shown in Fig. 1, would contribute a preferred sound; note in Fig. 1, the smooth surfaces contributing the surface morphology and note that the components containing the gaps are comprised of a material).
Regarding claim 12, Sharp discloses the inhaler add-on device according to claim 2, as discussed above.
Sharp further discloses wherein the first passive acoustic element (comprisal of 42 and 50) has a plurality of sets of gaps (see each of 48 and 52 which are gaps in the identified passive acoustic element) separated by different distances (see Fig. 1, where each of the gaps 48 in rotor 42 are separated by a different distance than the separation of each of gaps 52 in disc 50).
Regarding claim 13, Sharp discloses the inhaler add-on device according to claim 2, as discussed above.
Sharp further discloses wherein the first passive acoustic element (comprisal of 42 and 50) is configured to generate sound predominately within an audible level and in an audible frequency range, thereby allowing the user to hear tones indicative of inhalation air flow speed (page 7, lines 20-27 through page 8, lines 1-4: each pitch of whistle, which is based on air flow speed, contributes audible sound).
Regarding claim 16, Sharp discloses the inhaler add-on device according to claim 2, as discussed above.
Sharp further discloses wherein the first passive acoustic element (comprisal of 42 and 50) and the inhaler medicament compartment (28) are arranged in respective parallel flow paths (see Fig. 1, where 28 and 40 each include vertical axes in their respective flow paths which are parallel).
Regarding claim 18, Sharp discloses the inhaler add-on device according to claim 2, as discussed above.
Sharp further discloses wherein the first passive acoustic element (comprisal of 42 and 50) comprises a static structure (50) with no moving parts (page 7, lines 20-27 through page 8, lines 1-4, where 42 rotates, but 50 is static to create the whistling sound).
Regarding claim 21, Sharp discloses the inhaler add-on device according to claim 2, as discussed above.
Sharp further discloses wherein the first passive acoustic element (comprisal of 42 and 50) is a non-vibrating structure configured to generate sound by a movement of air passing the first passive acoustic element (comprisal of 42 and 50) (page 7, lines 20-27 through page 8, lines 1-4, where the whistling sound is created by virtue of air passing the elements, and none of the cited elements are described as vibrating to create a sound).
Regarding claim 22, Sharp discloses the inhaler add-on device according to claim 2, as discussed above.
Sharp further discloses wherein the one or more gaps (see each of 48 and 52 which are gaps in the identified passive acoustic element) are shaped and separated by a distance so as to generate sound depending on flow speed with predetermined characteristics comprising at least one spectral peak (page 7, lines 20-27 through page 8, lines 1-4: each pitch of whistle, which is based on air flow speed, would contribute a spectral component based on its sound, and one such pitch/whistle sound would create a peak with respect to its amplitude and/or its frequency).
Regarding claim 23, Sharp discloses the inhaler add-on device according to claim 2, as discussed above.
Sharp further discloses wherein the one or more gaps (see each of 48 and 52 which are gaps in the identified passive acoustic element) are straight gaps which are perpendicular to a direction of air flow passing the first passive acoustic element (comprisal of 42 and 50) (see Fig. 1 where gaps 52 are straight, and include a vertical component which is perpendicular to an inhalation air flow directed along the longitudinal axis of the mouthpiece; page 3, lines 6-13 for inhalation).
Regarding claim 24, Sharp discloses the inhaler add-on device according to claim 2, as discussed above.
Sharp further discloses wherein the first passive acoustic element (comprisal of 42 and 50) comprises a structure having teeth defining one or more gaps (see each of 48 and 52 which are gaps in the identified passive acoustic element) between them, wherein the one or more gaps (see each of 48 and 52 which are gaps in the identified passive acoustic element) are a passage through the structure with no material being present in the gaps (see each of 48 and 52 which are gaps in the identified passive acoustic element) (page 7, lines 20-27; Fig. 2, see the material on rotor 42 that forms apertures 48 where no material is present).
Regarding claim 25, Sharp discloses the inhaler add-on device according to claim 2, as discussed above.
Sharp further discloses wherein the first passive acoustic element (comprisal of 42 and 50) is positioned in the flow path downstream of an inhaler medicament compartment (10) configured to provide an inhalable medicament (page 4, lines 21-27; page 9, lines 12-16; Fig. 1, where upon user inhalation, inhalable medicament traverses the compartment 10 and then the passive acoustic element, thus placing it downstream of the compartment in that flow direction).
Regarding claim 26, Sharp discloses the inhaler add-on device according to claim 2, as discussed above.
Sharp further discloses wherein the first passive acoustic element (comprisal of 42 and 50) is positioned in the flow path upstream of an inhaler medicament compartment (10) configured to provide an inhalable medicament (page 4, lines 21-27; page 9, lines 12-16; Fig. 1, where upon user exhalation, flow traverses the compartment 10 after the passive acoustic element, thus placing it upstream of the compartment in that flow direction).
Regarding claim 27, Sharp discloses the inhaler add-on device according to claim 2, as discussed above.
Sharp further discloses wherein said device is configured to receive exhaled air via the air inlet or the air outlet (page 2, lines 8-12; page 8, lines 14-15), so as to generate sound with pre-determined characteristics depending on flow speed of air passing the first passive acoustic element (comprisal of 42 and 50), so as to allow acoustic monitoring of air flow passing the first passive acoustic element (comprisal of 42 and 50) external to the housing (exterior of 40) upon a user exhaling air into the air inlet or air outlet (page 8, lines 11-16, note that “external” is interpreted relative to the user exhaling, where the exhalation is originated external to the device).
Regarding claim 30, Sharp discloses the inhaler add-on device according to claim 2, as discussed above.
Sharp further discloses wherein the first passive acoustic element (comprisal of 42 and 50) is arranged in a flow path so as to receive a limited part of the air flow (note Figs. 1 and 2, where rotor 42 is placed in the flow path to be acted upon by a user’s inhalation or exhalation, but due to the apertures 48 and their surrounding material, it is expected that a portion of the airflow would be blocked where the rotor 42 does not include gaps 48, i.e. the material of 42 where no gaps are present would deflect the air flow, and thus only a limited portion of the air flow would traverse the apertures 48).
Regarding claim 31, Sharp discloses the inhaler add-on device according to claim 2, as discussed above.
Sharp further discloses wherein the first passive acoustic element (comprisal of 42 and 50) is arranged in an air flow path between an opening of the housing (exterior of 40) and air flow inside the housing (exterior of 40) (see Fig. 1, where 42 and 50 are situated between the opening at the right-hand side of the mouthpiece 40, and given that inhalable medicament is traversing compartment 10 on the left to be output at 40 per page 4, lines 21-27 and page 9, lines 12-16, there exists an air flow on the left side of 42 and 50).
Regarding claim 32, Sharp discloses the inhaler add-on device according to claim 2, as discussed above.
Sharp further discloses wherein the first passive acoustic element (comprisal of 42 and 50) is arranged in a flow path with a direction perpendicular to a flow path direction (see Fig. 1, the vertical element of 42 and 50 are perpendicular to the flow path direction which traverses the longitudinal aspect of 40 horizontally).
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 non-obviousness.
Claims 3, 5, and 28-29 are rejected under 35 U.S.C. 103 as being unpatentable over Sharp (GB 2,299,512), as applied to claim 2 above, in view of Spencer (GB 2,372,704).
Regarding claim 3, Sharp discloses the inhaler add-on device according to claim 2, as discussed above.
Sharp discloses that the passive acoustic element is made of polymeric materials (page 7, lines 20-21), however Sharp fails to disclose wherein the housing and the first passive acoustic element is formed as one single polymeric material.
However, Spencer teaches a first passive acoustic element (“audible signal generator”) in the mouthpiece of an inhaler, wherein the first passive acoustic element (“audible signal generator”) is an integral part of the mouthpiece (page 2, lines 28-35, see “integral part”).
Given that the Sharp mouthpiece, at its external portion, is the housing, and that Spencer teaches that passive acoustic elements can be made integral with a mouthpiece, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the passive acoustic element of Sharp to be formed as a single, integral polymeric material with the housing, as taught by Spencer, in order to reduce the number of moving parts of the device and thus reduce the manufacturing complexity.
Regarding claim 5, Sharp discloses the inhaler add-on device according to claim 2, as discussed above.
Sharp fails to disclose wherein the first passive acoustic element is a separate element attached to an inner structure of the housing, thereby allowing the housing and flow path elements to be re-used in several versions, where only the passive acoustic element itself is replaced.
However, Spencer teaches a first passive acoustic element (“audible signal generator”) in the mouthpiece of an inhaler, wherein the first passive acoustic element (“audible signal generator”) is a separate element attached to an inner structure of the housing (“mouthpiece”), thereby allowing the housing and flow path elements to be re-used in several versions, where only the passive acoustic element itself is replaced (page 2, lines 28-35, see “removable insert”, and thus the mouthpiece and inhaler are understood to be able to be reused with a new insert or without it).
Given that the Sharp mouthpiece, at its external portion, is the housing, and that Spencer teaches that passive acoustic elements can be made integral with a mouthpiece, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the passive acoustic element of Sharp to be formed as a separate element attached to an inner structure of the housing, thereby allowing the housing and flow path elements to be re-used in several versions, where only the passive acoustic element itself is replaced, as taught by Spencer, in order to allow the passive acoustic element to be replaced and removed as desired.
Regarding claim 28, Sharp discloses the inhaler add-on device according to claim 2, as discussed above.
Sharp fails to disclose wherein the first passive acoustic element is formed as a monolithic part of the housing.
However, Spencer teaches a first passive acoustic element (“audible signal generator”) in the mouthpiece of an inhaler, wherein the first passive acoustic element (“audible signal generator”) is formed as a monolithic part of the housing (“mouthpiece”) (page 2, lines 28-35, see “integral part”).
Given that the Sharp mouthpiece, at its external portion, is the housing, and that Spencer teaches that passive acoustic elements can be made integral with a mouthpiece, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the passive acoustic element of Sharp to be formed as a monolithic part of the housing, as taught by Spencer, in order to reduce the number of moving parts of the device and thus reduce the manufacturing complexity.
Regarding claim 29, Sharp discloses the inhaler add-on device according to claim 2, as discussed above.
Sharp fails to disclose wherein the housing and the first passive acoustic element are formed as a monolithic element.
However, Spencer teaches a first passive acoustic element (“audible signal generator”) in the mouthpiece of an inhaler, wherein the first passive acoustic element (“audible signal generator”) is formed as a monolithic part of the housing (“mouthpiece”) (page 2, lines 28-35, see “integral part”).
Given that the Sharp mouthpiece, at its external portion, is the housing, and that Spencer teaches that passive acoustic elements can be made integral with a mouthpiece, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the passive acoustic element of Sharp to be formed as a monolithic part of the housing, as taught by Spencer, in order to reduce the number of moving parts of the device and thus reduce the manufacturing complexity.
Claims 6, 8, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Sharp (GB 2,299,512), as applied to claim 2 above, in view of Kistler (US 4,291,688).
Regarding claim 6, Sharp discloses the inhaler add-on device according to claim 2, as discussed above.
Sharp fails to disclose wherein the one or more gaps are 0.5-3 mm wide, the length of the one or more gaps are 2-10 mm, and/or the material thickness around the one or more gaps is 0.5-3 mm.
However, Kistler teaches a sounding device (18) for an inhaler, and teaches that the sounding device is 2 mm thick (Col. 5, lines 38-41).
While Kistler describes that the sounding device is a reed, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have constructed the material around the one or more gaps to be around 2 mm thick as taught by Kistler, given that Kistler teaches that the sounding device is for use in an inhaler, because it is reasonable to expect that the general dimensions of the different passive acoustic elements can be constructed from similar material dimensions given their respective use within inhaler devices, and for the purpose of creating a sound to monitor air flow.
Regarding claim 8, Sharp discloses the inhaler add-on device according to claim 2, as discussed above.
Sharp further discloses that a cross-section of the one or more gaps (see 48 and 52) are rectangular (see Fig. 1 where the cross-section of the gaps 48 are rectangular about the longitudinal axis of the gaps 48).
Sharp fails to disclose wherein the one or more gaps include a length of 2-5 times the width.
However, Kistler teaches a sounding device (18) for an inhaler, and teaches that the sounding device is 2 mm by 11 mm in width verses length (Col. 5, lines 43-45, where 11 is 5.5 times 2, and thus is at least 5 times greater than 2).
While Kistler describes that the sounding device is a reed, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have constructed the material around the length of the first passive acoustic element to be about 5 times greater than the width as taught by Kistler, given that Kistler teaches that the sounding device is for use in an inhaler, because it is reasonable to expect that the general dimensions of the different passive acoustic elements can be constructed from similar material dimensions given their respective use within inhaler devices, and for the purpose of creating a sound to monitor air flow.
Regarding claim 10, Sharp discloses the inhaler add-on device according to claim 2, as discussed above.
Sharp further discloses that a cross-section of the one or more gaps (see 48 and 52) are rectangular and formed in two rows of parallel gaps (see Fig. 1 where the cross-section of the gaps 48 are rectangular about the longitudinal axis of the gaps 48, and there are at least two rows of gaps 48).
Sharp fails to disclose wherein the one or more gaps include a length of 2-5 times the width.
However, Kistler teaches a sounding device (18) for an inhaler, and teaches that the sounding device is 2 mm by 11 mm in width verses length (Col. 5, lines 43-45, where 11 is 5.5 times 2, and thus is at least 5 times greater than 2).
While Kistler describes that the sounding device is a reed, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have constructed the material around the length of the first passive acoustic element to be about 5 times greater than the width as taught by Kistler, given that Kistler teaches that the sounding device is for use in an inhaler, because it is reasonable to expect that the general dimensions of the different passive acoustic elements can be constructed from similar material dimensions given their respective use within inhaler devices, and for the purpose of creating a sound to monitor air flow.
Claims 9, 17, 34-35, and 37-39 are rejected under 35 U.S.C. 103 as being unpatentable over Sharp (GB 2,299,512), as applied to claim 2 above, in view of Leydon (US 2018/0064402).
Regarding claim 9, Sharp discloses the inhaler add-on device according to claim 2, as discussed above.
While Sharp discloses that the gaps include two parallel walls (see Figs. 1 and 2, where each of 52 and 48 include top and bottom parallel walls forming the gaps), Sharp fails to disclose wherein the one or more gaps have one tapered end.
However, Leydon teaches a whistle (104) provided with a flow controller that generates a sound for measurement of breath flow characteristics (paragraph 39, lines 1-5; Fig. 1), wherein the whistle (104) can be tapered to influence sound through it (paragraph 126, lines 1-5).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified one end of the parallel walls of the gaps of Sharp to be tapered, as taught by Leydon, in order to influence the sound of the Sharp sound device.
Regarding claim 17, Sharp discloses the inhaler add-on device according to claim 2, as discussed above.
Sharp fails to disclose wherein the air inlet is split into two separate openings each guiding air to the respective parallel flow paths, to allow the flow path around the passive acoustic element irrespective of an inhalation flow path.
However, Leydon teaches a whistle (1300) (paragraph 196, lines 1-4; Fig. 13), wherein the air inlet (202) is split into two separate openings each guiding air to the respective parallel flow paths to encourage laminar flow (paragraph 197, lines 1-8; paragraph 203, lines 1-8; Fig. 14, note that the partition 1306 creates the split of the air inlet).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the air inlet of Sharp to be split into two separate openings guiding air through parallel flow paths, as taught by Leydon, in order to encourage laminar flow through the inlet, and thereby, by the modification, allowing the flow path around the passive acoustic element irrespective of an inhalation flow path.
Regarding claim 34, Sharp discloses the inhaler add-on device of claim 2, as discussed above.
Sharp fails to disclose a microphone configured to capture sound from the first acoustic passive element, and further configured to transmit data in response to captured sound using a wired or wireless connection to an external device.
However, Leydon teaches an acoustic device or whistle (i.e. 104) provided with a flow controller that generates a sound for measurement of breath flow characteristics (paragraph 39, lines 1-5; Fig. 1) which includes a microphone configured to capture sound from the acoustic element (paragraph 39, lines 4-7), and is further configured to transmit data in response to captured sound using a wired connection to an external device (“hand-held mobile electronic device”) (paragraph 39, lines 4-14: the microphone is contained within the mobile electronic device, and processing circuitry within the mobile device is configured to record and analyze the sound captured by the microphone) to allow the system to be advantageously capable of generating information related to the user’s breathing based on the determined breath flow characteristics (paragraph 39, lines 15-22).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed by Sharp to further include an external device with a wired microphone for capturing and analyzing sound from the first passive acoustic element, as taught by Leydon, in order to use the captured sound information to determine respiratory characteristics of the patient based on the whistle/sound emission.
Regarding claim 35, Sharp in view of Leydon disclose the inhaler add-on device of claim 34, as discussed above.
Presently modified Sharp fails to disclose wherein the microphone, and a processor circuit connected thereto are configured to transmit said data, and a battery for powering the processor circuit, are housed in a second housing separate from the first housing, optionally the second housing is configured to attach to the inhaler.
Leydon further teaches wherein the microphone (paragraph 39, lines 4-7 of Johan), and a processor circuit connected thereto are configured to transmit said data (paragraph 39, lines 4-14), and a battery for powering the processor circuit, are housed in a second housing (paragraph 39, lines 4-14: the processing circuitry, microphone and a battery are included in the mobile device; and paragraph 108, lines 9-15 generally indicates the use of battery power within the system).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of modified Sharp to such that the microphone, a processor circuit connected thereto are configured to transmit said data, and a battery for powering the processor circuit, are housed in a second housing separate from the first housing (Sharp: exterior of 40), as taught by Leydon, such that the microphone can be powered and controlled via the processor circuit, and each of the microphone, circuit, and battery can be housed together in the mobile device with the passive acoustic element separate therefrom.
Regarding claim 37, Sharp discloses a system including the inhaler add-on device of claim 2, as discussed above.
Sharp fails to disclose a device configured to capture sound generated by the inhaler add-on device during an inhalation, wherein the device comprises a processor configured to process the captured sound according to a processing algorithm and to generate a measure of air flow through the air outlet of the inhaler in response to the processing algorithm.
However, Leydon teaches an acoustic device or whistle (104) provided with a flow controller that generates a sound for measurement of breath flow characteristics (paragraph 39, lines 1-5; Fig. 1) which includes a device configured to capture sound generated by the inhaler add-on device during an inhalation (paragraph 39, lines 4-14 discuss the use of a mobile device with a microphone and processor for capturing sound and analyzing the sound; paragraph 36, lines 1-8 and paragraph 338, lines 1-10 discuss the use of the whistle device during inhalation), wherein the device comprises a processor configured to process the captured sound according to a processing algorithm and to generate a measure of air flow through the air outlet of the inhaler in response to the processing algorithm (paragraph 39, lines 4-14 discuss the device and processing algorithm; paragraph 36, lines 1-8 and paragraph 338, lines 1-10 discuss the use of the whistle device during inhalation). Johan further teaches that the system is advantageously capable of generating information related to the user’s breathing based on the determined breath flow characteristics (paragraph 39, lines 15-22).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claime