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 .
Information Disclosure Statement
The information disclosure statements filed 24 Nov 2024 (only one of the two filed that day) and 21 Jun 2025 fail to comply with 37 CFR 1.98(a)(1) and 37 CFR 1.98(b)(5) because they do not include a proper listing of the non-patent literature documents being presented. The phrasing “Translation of abstracts of foreign patent documents enclosed with this IDS” is not a proper detailed listing of the information being presented for review. Any non-patent literature document being submitted should be individually listed with its relevant information (see MPEP 609.01(B)(1)(e)(v)).
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the liquid medicine detection module (claim 10) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim(s) 1-10 is/are objected to because of the following informalities:
Claim 1, Ln. 9 recites “the breathing tube is in fluid communication with a patient's respiratory tract” which should read “the breathing tube is configured to be in fluid communication with a patient's respiratory tract” in order to avoid inadvertently positively reciting the patient
Claim 1, Ln. 13 recites “at least one medicinal liquids” which should read “at least one of the medicinal liquids” following after Ln. 6
Claim 2, Ln. 7 recites “specific liquid medicine” which should read “selected medicinal liquid” following after claim 1
Claim 2, Ln. 8 recites “the respective liquid medicine container” which should read “the respective container” following after claim 1
Claim 3, Ln. 2 recites “the medicinal liquid containers” which should read “the containers” following after claim 1
Claim 4, Ln. 2-3 recites “the corresponding plurality of the liquid medicine containers” which should read “the corresponding plurality of containers” following after claim 1
Claim 6, Ln. 4 recites “liquid medicine” which should read “medicinal liquid” following after claim 1
Claim 6, Ln. 4-5 recites “the plurality of liquid medicine containers” which should read “the plurality of containers” following after claim 1
Claim 10, Ln. 3 recites “the plurality of liquid medicine containers” which should read “the plurality of containers” following after claim 1
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim(s) 1-10 is/are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recited the limitation “atomization module” which invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The atomization module is then further defined in claim 2 as “a switching module” and “an energy module” which also both invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The specification describes atomization module 30 as including switching module 31 and energy module 32 (e.g. ¶0029 of the PGPub copy of the instant application). While the specification does discuss switching module 31 and energy module 32 (e.g. ¶0029 of the PGPub copy of the instant application) the written description fails to disclose the corresponding structure, material, or acts for meaningfully performing the entire claimed function and to clearly link the structure, material, or acts to the function. The specification describes the switching module 31 as able to provide either compressed gas or ultrasonic energy to the specific liquid container 40 (¶0029 of the PGPub). The specification further discusses switching module 31 as having a plurality of channels each communicating with a respective one of liquid medicine containers 40 (¶0029 of the PGPub). The energy module 32 is discussed as electrically controlled by the main control module 20 to cause energy to be provided to the switching module 31 to cause atomization. However, no particular structure is discussed for energy module 32. One of ordinary skill in the art would be left to question what type of structure applicant intends as energy module 32 which would be electrically controlled by the main control module 20 and also operate to provide energy to switching module 31 to cause atomization at liquid medicine containers 40. Further, while it might be understood how the plurality of channels of switching module 31 can be used to route compressed gas to individual liquid medicine containers 40 there is no discussion in the written description as to how the switching module 31 would use its plurality of channels to provide energy to individual liquid medicine containers 40 to perform the disclosed option of using ultrasonic energy for atomization at the liquid medicine containers 40. The specification thus fails to provide sufficient guidance as to the particular structures of switching module 31 and energy module 32 (and thus atomization module 30) to enable one of ordinary skill in the art to clearly understand the claimed invention. Thus, the application as originally filed fails to provide sufficient written description for the overall breadth encompassed in the specification for the atomization module, switching module and an energy module of claims 1 and 2, with particular consideration to the lack of discussion of how switching module 31 and energy module 32 would individually operate to supply energy to a selected liquid container 40 while both being electrically controlled by main control module 20. One of ordinary skill in the art would not be suitably apprised as to how to make and use the claimed invention in light of the lack of clear and detailed discussion of structures encompassing the claimed atomization module, and its two sub-modules, in the specification.
Claim 10 recites the limitation “liquid medicine detection module” which invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The specification only describes the liquid medicine detection module as performing detection of the types and/or concentrations of medicinal liquids in the plurality of medicinal liquid containers 40 (e.g. ¶0042 of the PGPub copy of the instant application) but fails to actually describe any particular structure to perform that claimed function. Thus, the application as originally filed fails to provide sufficient written description support for the claimed liquid medicine detection module. One of ordinary skill in the art would not be suitably apprised as to how to make and use the claimed invention.
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.
Claim(s) 1-10 is/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 pre-AIA the applicant regards as the invention.
In claim 1 the limitation “atomization module” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The atomization module is then further defined in claim 2 as “a switching module” and “an energy module” which also both invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The specification describes atomization module 30 as including switching module 31 and energy module 32 (e.g. ¶0029 of the PGPub copy of the instant application). While the specification does discuss switching module 31 and energy module 32 (e.g. ¶0029 of the PGPub copy of the instant application) the written description fails to disclose the corresponding structure, material, or acts for meaningfully performing the entire claimed function and to clearly link the structure, material, or acts to the function. The specification describes the switching module 31 as able to provide either compressed gas or ultrasonic energy to the specific liquid container 40 (¶0029 of the PGPub). The specification further discusses switching module 31 as having a plurality of channels each communicating with a respective one of liquid medicine containers 40 (¶0029 of the PGPub). The energy module 32 is discussed as electrically controlled by the main control module 20 to cause energy to be provided to the switching module 31 to cause atomization. However, no particular structure is discussed for energy module 32. One of ordinary skill in the art would be left to question what type of structure applicant intends as energy module 32 which would be electrically controlled by the main control module 20 and also operate to provide energy to switching module 31 to cause atomization at liquid medicine containers 40. Further, while it might be understood how the plurality of channels of switching module 31 can be used to route compressed gas to individual liquid medicine containers 40 there is no discussion in the written description as to how the switching module 31 would use its plurality of channels to provide energy to individual liquid medicine containers 40 to perform the disclosed option of using ultrasonic energy for atomization at the liquid medicine containers 40. The specification thus fails to provide sufficient guidance as to the particular structures of switching module 31 and energy module 32 (and thus atomization module 30) to enable one of ordinary skill in the art to clearly understand the claimed invention. Thus, the written description fails to suitably identify the full scope of corresponding structures for performing the full functions recited by the claim, in light of the 35 U.S.C. 112(f) interpretation required of claims 1 and 2. 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.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
In claim 10 the limitation “liquid medicine detection module” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The specification only describes the liquid medicine detection module as performing detection of the types and/or concentrations of medicinal liquids in the plurality of medicinal liquid containers 40 (e.g. ¶0042 of the PGPub copy of the instant application) but fails to actually describe any particular structure to perform that claimed function. 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.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claim Interpretation - 35 USC § 112(f)
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: “main control module” in claim 1, “atomization module” in claim 1, “switching module” in claim 2, “energy module” in claim 2, “detection module” in claim 6, “display input module” in claim 8, and “liquid medicine detection module” in claim 10.
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.
The corresponding structure for the main control module is best understood from the specification as at least: main control module 20 having the form of basic electronic hardware (e.g. Fig. 1).
The corresponding structure for the atomization module is best understood from the specification as at least: atomization module 30 including a switching module 31 having a plurality of channels each communicating with a respective one of liquid medicine containers 40 which provide either compressed gas or ultrasonic energy for atomization, and energy module 32 which is controlled by the main control module 20 to cause energy, in the form of either compressed gas or ultrasonic energy, to be provided to the switching module 31 to cause atomization (¶¶0029, 0043 of the PGPub copy of the instant application; Fig. 1).
The corresponding structure for the detection module is best understood from the specification as at least: a weighing of the liquid medicine container 40 (¶0036 of the PGPub copy of the instant application).
The corresponding structure for the display input module is best understood from the specification as at least: display input module 70 as a display which provides a user interface for receiving input (¶0039 of the PGPub copy of the instant application).
The corresponding structure for the liquid medicine detection module is best understood from the specification as at least: no structure is disclosed.
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 § 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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-2, 4 and 10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sugita et al. (U.S. Pub. 2008/0011292).
Regarding claim 1, Sugita discloses an automatic medicine exchange and atomization device (Figs. 1-5; ¶0027) for nebulization of a patient, comprising: a breathing tube (¶0072 – air tube within Fig. 4); a main control module (Figs. 1 & 5 #18; ¶0074); an atomization module (Fig. 1 #18b, 18c; ¶0027) that is electrically connected with the main control module (Fig. 1); a plurality of containers (Figs. 1 & 4 #12, 13; ¶0027) of respective medicinal liquids connected to the atomization module (Fig. 1); in which: the breathing tube is configured to be in fluid communication with a patient's respiratory tract (¶0072); at least one of the plurality of containers is in fluid communication with the breathing tube (¶¶0027, 0072); and the main control module is provided to cause the atomization module to selectively atomize at least one of the medicinal liquids in the corresponding containers (¶0027), whereby each atomized selected medicinal liquid enters the breathing tube (Fig. 4; ¶0072). Decision section 18b and drive controller 18c are read as a functional equivalent of the disclosed embodiment of the atomization module which applies ultrasonic energy to perform liquid ejection. It is noted that the particular language “the main control module is provided to cause the atomization module to selectively atomize at least one of the medicinal liquids in the corresponding containers” is understood to imply that atomization occurs in the containers based upon a form of activation provided to the containers from the atomization module. Thus, the atomization module itself does not perform atomization but merely causes atomization to occur in in the corresponding containers.
Regarding claim 2, Sugita discloses a switching module (Fig. 1 #18c; ¶0027) and an energy module (Fig. 1 #18b; ¶0027), both of which are included in the atomization module and are electrically connected to the main control module (Fig. 1); in which: the energy module is provided for inputting atomization energy to the switching module (Fig. 1; ¶0027), said atomization energy causing the atomization of the at least one selected medicinal liquid in the respective container (Fig. 1; ¶0027).
Regarding claim 4, Sugita discloses a plurality of position sensors (¶0071 – identification code readers), each detecting positions of the corresponding plurality of containers within the device.
Regarding claim 10, Sugita discloses a liquid medicine detection module detecting at least one of a type (¶0071 – identification code identifies medicine in the cartridge) .
Claim(s) 1 and 9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Eichler (U.S. Patent 4558710).
Regarding claim 1, Eichler discloses an automatic medicine exchange and atomization device (Fig. 1; Col. 2-3) for nebulization of a patient, comprising: a breathing tube (Fig. 1 #12; Col. 2, Ln. 58-68); a main control module (Fig. 1 #30; Col. 3, Ln. 1-8); an atomization module (Fig. 1 #32b, 34b, 38, 40, 42; Col. 3, Ln. 33-44) that is electrically connected with the main control module (Fig. 1); a plurality of containers (Fig. 1 #32, 34; Col. 3, Ln. 25-32) of respective medicinal liquids connected to the atomization module (Fig. 1); in which: the breathing tube is configured to be in fluid communication with a patient's respiratory tract (Fig. 1); at least one of the plurality of containers is in fluid communication with the breathing tube (Fig. 1); and the main control module is provided to cause the atomization module to selectively atomize at least one of the medicinal liquids in the corresponding containers (Figs. 1 & 3; Col. 3, Ln. 55 – Col. 4, Ln. 22 – control of valves 38, 40), whereby each atomized selected medicinal liquid enters the breathing tube (Fig. 1). Compressed air connections 32b, 34b, valves 38, 40 and air supply 42 are read as a functional equivalent of the disclosed embodiment of the atomization module which applies compressed gas to perform atomization. It is noted that the particular language “the main control module is provided to cause the atomization module to selectively atomize at least one of the medicinal liquids in the corresponding containers” is understood to imply that atomization occurs in the containers based upon a form of activation provided to the containers from the atomization module. Thus, the atomization module itself does not perform atomization but merely causes atomization to occur in in the corresponding containers.
Regarding claim 9, Eichler discloses a filter (Fig. 1 #16; Col. 2, Ln. 62-65) arranged in the breathing tube, said filter filtering gas within in the breathing tube.
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 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sugita et al. (U.S. Pub. 2008/0011292) in view of Germinario et al. (U.S. Pub. 2017/0319797).
Regarding claim 7, Sugita fails to disclose a flow sensor arranged in the breathing tube, the flow sensor being electrically connected with the switching module and being configured to detect flow in the breathing tube and generating a second signal corresponding to the detected flow; in which the main control module is configured to control the switching module to perform atomization according to the second signal.
Germinario teaches a droplet delivery device (e.g. Fig. 1A) including an airflow sensor in the form of a differential pressure sensor (¶¶0087, 0096) which upon detection of a user’s inhalation causes generation of an ejected stream of droplet (¶0087). Germinario teaches an airflow sensor as providing the benefit of triggering droplet generation only specifically when inhalation is occurring (¶0087).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have incorporated in Sugita a flow sensor arranged in the breathing tube, the flow sensor being electrically connected with the switching module and being configured to detect flow in the breathing tube and generating a second signal corresponding to the detected flow; in which the main control module is configured to control the switching module to perform atomization according to the second signal in order to provide the benefit of triggering atomization only specifically when inhalation is occurring in view of Germinario.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sugita et al. (U.S. Pub. 2008/0011292) in view of Lawrenson et al. (U.S. Pub. 2021/0401038).
Regarding claim 8, Sugita discloses a display input module electrically connected with the main control module and generating and communicating to the main control module a third signal (¶0078 – user input).
Sugita fails to disclose the main control module is configured to determine an atomization amount and a number of times of atomization of the selected one of the medicinal liquids according to the third signal.
Lawrenson teaches an inhaler (e.g. Figs. 1a-1b) including a plurality of liquid reservoirs storing different liquids (Fig. 1b #122; ¶0092) and teaches the liquid drugs as deliverable to a user based upon a prescription which includes both dosage amount and timing (¶¶0170-0171). Lawrenson teaches determining an atomization amount and a number of times of atomization in response to an input signal as providing the benefit of ensuring a user is only receiving drugs in accordance with a prescription (¶¶0170-0171).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have incorporated in Sugita the main control module is configured to determine an atomization amount and a number of times of atomization of the selected one of the medicinal liquids according to the third signal in order to provide the benefit of ensuring a user is only receiving drugs in accordance with a prescription in view of Lawrenson.
Allowable Subject Matter
Claim(s) 3 and 5-6 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), 1st paragraph and 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 3, neither Sugita nor Eichler teaches or suggests at least one one-way valve, at least one of the containers being connected with a corresponding one of the one-way valves, said one-way valve restricting flow of the selected medicinal liquid to only an inhalation direction within the breathing tube. Specifically, the claim requires a one-way valve in direct interaction with a corresponding one of the containers. Additionally, the particular location and function recited of the one-way valve indicates that it must be located at an outlet of the container. While one-way valves are commonly used in the respiratory art they are typically located across a width of a breathing tube and not specifically at an outlet of the container where atomization is occurring. For example, Koehler et al. (U.S. Pub. 2014/0290646) teaches a nose mask 2 including a switching valve so the patient doesn’t inhale back into a tube from which nebulization medicament is provided (¶0053; Fig. 1). There is thus not found to be a preponderance of the evidence that one having ordinary skill in the art would have considered it prima facie obvious to have specifically located a one-way valve at an outlet of the container where atomization is occurring instead of in a further downstream location.
It is thus found that one having ordinary skill in the art at the time of the effective filing of the invention would only have arrived at the instantly claimed invention by way of improper hindsight reasoning.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure, see PTO-892 for additional attached references.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH D BOECKER whose telephone number is (571)270-0376. The examiner can normally be reached M-F 9:00 AM - 4:00 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kendra Carter can be reached at (571) 272-9034. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JOSEPH D. BOECKER/Primary Examiner, Art Unit 3785