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 06-28-2024. As directed, claims 1-12 are presently pending examination.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Objections
Claims 1, 4, 9, and 12 are objected to because of the following informalities:
At claim 1, line 5, it is suggested that “blocks” be replaced with “is configured to block” to avoid recitation of positive method steps in an apparatus claim.
At claim 1, line 7, it is suggested that “is deformed by” be replaced with “is configured to be deformed by” to avoid recitation of positive method steps in an apparatus claim.
At claim 4, line 10, it is suggested that “blocks” be replaced with “is configured to block” to avoid recitation of positive method steps in an apparatus claim.
At claim 4, line 12, it is suggested that “is deformed by” be replaced with “is configured to be deformed by” to avoid recitation of positive method steps in an apparatus claim.
At claim 9, line 2, it is suggested that “blocks” be replaced with “is configured to block” to avoid recitation of positive method steps in an apparatus claim.
At claim 9, line 4, it is suggested that “froms” be replaced with “forms” for clarity.
At claim 12, line 4, it is suggested that “the activation” be replaced with “an activation” as the term was not previously introduced.
Appropriate correction is required.
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 4-12 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.
Claim limitation “nebulizing module” in claims 4-5 and 12 has been evaluated under the three-prong test set forth in MPEP § 2181, subsection I, but the result is inconclusive. Thus, it is unclear whether this limitation should be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the term “module” is a non-structural term modified by the functional language “nebulizing”. However, each time the term is introduced in the specification, it is also as a “nebulizing module” without further expanding on what type of nebulizing module is provided. The boundaries of this claim limitation are ambiguous; therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
In response to this rejection, applicant must clarify whether this limitation should be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. Mere assertion regarding applicant’s intent to invoke or not invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph is insufficient. Applicant may:
(a) Amend the claim to clearly invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, by reciting “means” or a generic placeholder for means, or by reciting “step.” The “means,” generic placeholder, or “step” must be modified by functional language, and must not be modified by sufficient structure, material, or acts for performing the claimed function;
(b) Present a sufficient showing that 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, should apply because the claim limitation recites a function to be performed and does not recite sufficient structure, material, or acts to perform that function;
(c) Amend the claim to clearly avoid invoking 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, by deleting the function or by reciting sufficient structure, material or acts to perform the recited function; or
(d) Present a sufficient showing that 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, does not apply because the limitation does not recite a function or does recite a function along with sufficient structure, material or acts to perform that function.
For the purposes of examination, the nebulizing module will be read as any structure capable of producing a nebulized aerosol.
Claims 5-12 are rejected by virtue of their dependence on claim 4. Claim 6 is rejected by virtue of its dependence on claim 5.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Narayan (US 2003/0019493) in view of Tsai (US 2019/0076605).
Regarding claim 1, Narayan discloses an optical sensing module (24) applied to an inhaler (10) (paragraph 53, lines 1-13; Fig. 1), the inhaler (10) including a nozzle (paragraph 52, lines 10-11; Fig. 1), and the optical sensing module (24) comprising:
an optical sensor (32) disposed inside the inhaler (10) (paragraph 53, lines 1-13; paragraph 54, lines 1-13; Figs. 1-2); and
a membrane structure (28+30) disposed in the inhaler (10), wherein the membrane structure (28+30) blocks between the nozzle (20) and the optical sensor (32) (paragraph 53, lines 1-11, note that the membrane is understood to be in a pathway between the LED/sensor arrangement and the mouthpiece since it is responsive to inhalation; paragraph 54, lines 1-13; Fig. 2);
wherein, when a user inhales against the nozzle (20), the membrane structure (28+30) is deformed by a pressure difference generated inside the nozzle (20), and the optical sensor (32) is used to detect a deformation amount of the membrane structure (28+30) and output a sensing signal (paragraph 53, lines 1-13; paragraph 54, lines 1-13; Figs. 1-2).
Narayan fails to disclose that the optical sensing module is used within a nebulizer.
However, Tsai teaches a nebulizer (D) that includes a nozzle (N), and a sensing module (S) disposed within the nebulizer (N) for sensing user inhalation (paragraph 25, lines 1-14; paragraph 28, lines 1-11; Fig. 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 used the optical sensing module of Narayan in a nebulizer such as that taught by Tsai, since Tsai details and teaches the use of a sensor for detecting a pressure change in a nozzle due to inhalation within a nebulizer.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Narayan (US 2003/0019493) in view of Tsai (US 2019/0076605), as applied to claim 1 above, in further view of Nowacki (AU 620375).
Regarding claim 2, Narayan in view of Tsai disclose the optical sensing module according to claim 1, as discussed above.
Modified Narayan fails to disclose wherein the membrane structure is made of an elastomer.
However, Nowacki teaches an inhaler (see title and abstract) including a diaphragm (44) that is responsive to pressure differential, wherein the diaphragm (44) is composed of an elastomer (page 6, lines 16-24).
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 membrane structure of modified Narayan to be made from an elastomer, as taught by Nowacki, given that both Narayan and Nowacki describe respective structures that respond to pressure differentials, as a known material for allowing relative motion of the membrane due to an inhalation pressure.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Narayan (US 2003/0019493) in view of Tsai (US 2019/0076605), as applied to claim 1 above, in further view of Nowacki (AU 620375).
Regarding claim 3, Narayan in view of Tsai disclose the optical sensing module according to claim 1, as discussed above.
Modified Narayan fails to disclose wherein a thickness of the membrane structure ranges between 0.01 mm and 0.005 mm.
However, Novak, III teaches a flexible member (147) in an inhaler device for forming a sensor seal (144), wherein the thickness ranges between 0.01 mm and 0.2 mm (paragraph 74, lines 1-10; Fig. 9).
In the case where the range disclosed by the prior art overlaps a claimed range, a prima facie case of obviousness exists (see MPEP 2144.05 I). The range of 0.01 mm to 0.2 mm overlaps the end point of the claimed range of 0.005 mm to 0.01 mm. Thus, a prima facie case of obviousness exists.
Therefore, given that each of Narayan and Novak, III disclose/teach flexible membrane in relation to sensors, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have selected the thickness of the modified Narayan membrane structure to be in the range of 0.01 mm and 0.2 mm, as taught by Novak, III, as a known thickness for a flexible membrane structure placed in relation to a sensor.
Claims 4-9 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Chang (US 2022/0305221) in view of Narayan (US 2003/0019493) and Tsai (US 20190076605).
Regarding claim 4, Chang discloses a nebulizer (Z) (paragraph 25, lines 1-12; Fig. 9), comprising:
a host (2) including a detection hole (see Fig. 9, and the opening for connecting N1 and 2; paragraph 25, lines 12-15);
a cup body (N1) disposed on a top of the host (2) (paragraph 26, lines 1-12; Fig. 9);
a nozzle assembly (N) disposed on the cup body (N1), wherein the nozzle assembly (N) has a nozzle (N3) (paragraph 26, lines 1-3; paragraph 37, lines 17-18; Fig. 9);
a nebulizing module (1) disposed in the cup body (N1) (paragraph 26, lines 10-13; Fig. 9).
Chang fails to disclose an optical sensing module including:
an optical sensor disposed inside the host; and
a membrane structure disposed in the detection hole, wherein the membrane structure blocks between the nozzle and the optical sensor;
wherein, when a user inhales against the nozzle, the membrane structure is deformed by a pressure difference generated inside the nozzle, and the optical sensor is used to detect a deformation of the membrane structure and output a sensing signal.
However, Narayan teaches an optical sensing module (24) applied to an inhaler (10) (paragraph 53, lines 1-13; Fig. 1), the inhaler (10) including a nozzle (paragraph 52, lines 10-11; Fig. 1), and the optical sensing module (24) comprising:
an optical sensor (32) disposed inside the inhaler (10) (paragraph 53, lines 1-13; paragraph 54, lines 1-13; Figs. 1-2); and
a membrane structure (28+30) disposed in the inhaler (10), wherein the membrane structure (28+30) blocks between the nozzle (20) and the optical sensor (32) (paragraph 53, lines 1-11, note that the membrane is understood to be in a pathway between the LED/sensor arrangement and the mouthpiece since it is responsive to inhalation; paragraph 54, lines 1-13; Fig. 2);
wherein, when a user inhales against the nozzle (20), the membrane structure (28+30) is deformed by a pressure difference generated inside the nozzle (20), and the optical sensor (32) is used to detect a deformation amount of the membrane structure (28+30) and output a sensing signal (paragraph 53, lines 1-13; paragraph 54, lines 1-13; Figs. 1-2), wherein the optical sensing module is configured to detect a user inhalation in order to actuate a piezoelectric member for activating aerosol generation in the device in response to inhalation (paragraph 53, lines 11-13; paragraph 54, lines 11-13).
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 Chang to include an optical sensing module with an optical sensor and a membrane structure capable of being deformed by a pressure differential, as taught by Narayan, in order to actuate the Chang nebulizing module for activating aerosol generation in the device in response to inhalation.
Modified Chang fails to explicitly disclose wherein the optical sensing module is contained within the host and the membrane structure is disposed inside the detection hole.
However, Tsai teaches a nebulizer (D) with a controller (C) and a sensing module (S) disposed in a host (3) (paragraph 31, lines 1-8; Fig. 7), wherein the sensing module (S) disposed within the nebulizer (N) is for sensing user inhalation, and the sensing module (S) is disposed within a cavity of the host (3) (paragraph 25, lines 1-14; paragraph 28, lines 1-11; Figs. 5 and 7, note that the cavity of 3 is taken as the detection hole).
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 Chang such that the optical sensing module is contained within the host and the membrane structure is disposed inside the detection hole, as taught by Tsai, as a known configuration of housing a sensor module in a nebulizer similar in structure to that of Chang.
Regarding claim 5, Chang in view of Narayan and Tsai disclose the nebulizer according to claim 4, as discussed above.
Chang further discloses wherein the cup body (N1) includes a first housing (N1A) and a second housing (N1B) (paragraph 26, lines 1-10; Fig. 2), the second housing (N1B) includes a first connection opening, a second connection opening, and a third connection opening that are in fluid communication with each other (paragraph 26, lines 1-15; see annotated Fig. 2 below), the first housing (N1A) is disposed on the first connection opening (paragraph 26, lines 7-8; Fig. 2), the nebulizing module (1) is disposed on a bottom of the first housing (N1A) (paragraph 37, lines 14-16; Figs. 3 and 6-7), the nozzle assembly (N) is disposed on the second connection opening (paragraph 37, lines 16-19 and Fig. 10), and the second housing (N1B) is coupled to the host (2) through the third connection opening (paragraph 26, lines 11-15; Fig. 9).
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Regarding claim 6, Chang in view of Narayan and Tsai disclose the nebulizer according to claim 5, as discussed above.
Presently modified Chang fails to disclose wherein the membrane structure and the nozzle have a gas diffusion channel therebetween, the membrane structure and the optical sensor have a detection channel therebetween, and the gas diffusion channel and the detection channel are separated from and not in fluid communication with each other.
However, Tsai further teaches wherein the sensor (S) and the nozzle (N) have a gas diffusion channel (2) therebetween (paragraph 25, lines 1-15; Figs. 5 and 7).
Further, Narayan teaches wherein the membrane structure (28+30) and the optical sensor (32) have a detection channel therebetween (see the space provided between 36 and 34 where extension 30 is placed within, this space is the detection channel).
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 provided a gas diffusion channel between the membrane structure of modified Chang (note that the membrane of Narayan is part of the optical sensing module, and thus would be placed in the Chang nebulizer in a similar manner as the senor S in Tsai) and the nozzle of modified Chang, and to include a detection channel between the membrane structure and the optical sensor, where these placements are taught by each of Tsai and Narayan in combination, as a known method of installing the optical sensing module and its components between the nozzle and the host of modified Chang to place the sensing module in fluid communication with the nozzle to be able to measure inhalation pressure by the membrane structure displacement and optical sensor taught by Narayan.
Further, as modified, the device of modified Chang further includes wherein the gas diffusion channel and the detection channel are separated from and not in fluid communication with each other (see each of Figure 2 of Narayan which shows that the detection channel is blocked by membrane portion 28, and Figures 5 and 7 of Tsai which provide the gas diffusion channel; by modification, the gas diffusion channel is bounded on one side by the nozzle and at the other by the membrane of the optical sensing module, and the detection channel is bounded on one end by the membrane structure of the optical sensing module. As seen in the instant application at Figures 4-5, it appears that the “not in fluid communication” limitation of the present application is achieved by using membrane structure 2 to delineate each channel, thus modified Chang reads on the claimed limitations).
Regarding claim 7, Chang in view of Narayan and Tsai disclose the nebulizer according to claim 4, as discussed above.
Presently modified Chang fails to disclose a hollow pipe, wherein the hollow pipe is attached to a surface of the nozzle assembly, the hollow pipe includes a connection opening and a detection opening, the connection opening is connected to the optical sensor, and the detection opening is exposed and adjacent to the nozzle.
However, Tsai further teaches a hollow pipe (2) (paragraph 25, lines 1-12; Figs. 5 and 7), wherein the hollow pipe (2) is attached to a surface of the nozzle assembly (N) (paragraph 25, lines 1-4; Figs. 5 and 7), the hollow pipe (2) includes a connection opening (22) and a detection opening (21) (paragraph 25, lines 7-9; Figs. 5 and 7), the connection opening (22) is connected to the sensor (S), and the detection opening (21) is exposed and adjacent to the nozzle (N) (paragraph 25, lines 9-12; Figs. 5 and 7).
Given that modified Chang includes an optical sensing module as its sensor, 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 arrangement of the nozzle and the optical sensing module of modified Chang to further include a hollow pipe, wherein the hollow pipe is attached to a surface of the nozzle assembly, the hollow pipe includes a connection opening and a detection opening, the connection opening is connected to the optical sensor, and the detection opening is exposed and adjacent to the nozzle, as taught by Tsai, in order to facilitate connection of the nozzle and the sensing module for detection of the pressure due to a user’s inhalation.
Regarding claim 8, Chang in view of Narayan and Tsai disclose the nebulizer according to claim 7, as discussed above.
Modified Chang further discloses wherein the nozzle is aligned with the detection opening (21) (see Tsai: Fig. 1, where opening 11 of nozzle assembly N is vertically aligned with 21).
Regarding claim 9, Chang in view of Narayan and Tsai disclose the nebulizer according to claim 7, as discussed above.
Modified Chang further discloses wherein the hollow pipe (Tsai: 2) includes a first part and a second part (see portion of 2 before sensor in Tsai’s Figures 5 and 7; see Fig. 2 of Narayan where the second part is formed in the space between 34 and 36 where extension 30 lies), the membrane structure (Narayan: 28+30) blocks between the first part and the second part, the first part forms a detection channel between the membrane structure (Narayan: 28+30) and the optical sensor (Narayan: 32, note the placement of sensor S in Tsai’s Figures 5 and 7, where the space between 34 and 36 where extension 30 lies in Narayan is the detection channel), the second part forms a gas diffusion channel between the membrane structure (Narayan: 28+30) and the detection opening (21), and the gas diffusion channel and the detection channel are separated from and not in fluid communication with each other (Tsai: paragraph 25, lines 1-15; Figs. 5 and 7; see each of Figure 2 of Narayan which shows that the detection channel is blocked by membrane portion 28, and Figures 5 and 7 of Tsai which provide the gas diffusion channel; by modification, the gas diffusion channel is bounded on one side by the nozzle and at the other by the membrane of the optical sensing module, and the detection channel is bounded on one end by the membrane structure of the optical sensing module. As seen in the instant application at Figures 4-5, it appears that the “not in fluid communication” limitation of the present application is achieved by using membrane structure 2 to delineate each channel, thus modified Chang reads on the claimed limitations).
Regarding claim 12, Chang in view of Narayan and Tsai disclose the nebulizer according to claim 4, as discussed above.
Modified Chang further discloses a control module (note in Chang, the host 2 is defined as a control module, so the internal structure is understood to include control components) electrically connected to the nebulizing module (Chang: 1) and the optical sensor (Narayan: 24, modified to be placed in the host 2 of Chang by Tsai’s teachings), wherein the control module (Chang: circuitry of 2) is used to receive the sensing signal and control the activation of the nebulizing module (Chang: 1) (Chang: paragraph 25, final four lines; Narayan: paragraphs 53-54, note that sensing data controls the activation/triggering of aerosol generation; see also Tsai: paragraph 39: “The sensor S detects the negative pressure to generate a negative pressure signal and transmits the negative pressure signal to the controlling module C. Then, the controlling module C produces a starting signal based on the negative pressure signal, and transmits the starting signal to the atomizing module E. After receiving the starting signal, the atomizing module E starts to atomize the liquid medicines in the accommodating assembly A”).
Allowable Subject Matter
Claims 10-11 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims, and if claims 4-23 were amended to overcome the rejections under 35 USC 112(b) above.
The following is a statement of reasons for the indication of allowable subject matter:
Each of claims 10 and 11 require the inclusion of a transparent barrier for blocking moisture from entering the detection chamber. As defined with respect to Narayan, the detection channel is located between the elements 34 and 36 in Figure 2. Placement of a barrier directly before this channel below element 28 would not be prima facie obvious because doing so would block the movement of the membrane structure (28+30). Further, placement of this barrier above element 28 would block the necessary airflow from inhalation that acts on the membrane structure (28+30) to indicate the pressure differential due to inhalation, thus rendering the combination of elements unsuitable for its intended purpose. Still further, modification of the membrane structure (28+30) to be transparent would necessarily allow light beam 38 to travel through extension 30, and then inhalation pressure would not be detected, also rendering the combination of elements unsuitable for its intended purpose. No additional art has been identified which discloses and/or teaches the combination of elements in the optical sensing module within a respiratory device as claimed. Thus, no other references can overcome the deficiency of the Chang-Narayan-Tsai combination.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
JP 7155010 is cited for its teaching of an optical sensor 190 in Figure 50.
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/PAIGE KATHLEEN BUGG/Primary Examiner, Art Unit 3785
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