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 1-15 are currently pending examination.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Objections
Claim 10 is objected to because of the following informalities:
At claim 10, line 1, it is suggested that “Wherein” be added before “the side wall” for clarity.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
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:
A/the sealing member in claim 5 which is interpreted relative to paragraph 29 of the instant specification to be an o-rig/gasket and functional equivalents thereof.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 15 is 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” 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 refers to the claimed element as “nebulizing module” and is shown at Figures 4-5 as element B3. Neither the specification, nor the drawing provides additional information as to what type of structure forms the nebulizing module. 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 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 1-5, 7, 9-10, 13, and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Costella (US 2018/0161531).
Regarding claim 1, Costella discloses a medication adjustment device, comprising:
a liquid reservoir (14 which includes 46) including a first opening and a second opening, wherein the liquid reservoir (14 which includes 46) includes an accommodating cavity (26), and the first opening communicates with the second opening through the accommodating cavity (paragraph 127, lines 1-5; paragraph 129, lines 1-7; paragraph 137, final six lines; Fig. 2, see annotated version below for first and second openings; Fig. 3A); and
a medication adjustment member (18, 20, and 22) detachably disposed on the first opening and located in the accommodating cavity (26) (see Figs. 2-3B), wherein the medication adjustment member (18, 20, and 22) includes a third opening (either one of openings 96 or the top opening of nozzle cover 34) and an adjustment opening (when the third opening is the top opening in 34, the adjustment opening is the bottom opening in nozzle cover 34; when the third opening is 96, adjustment opening is taken as openings/channel in nozzle cover 34), the medication adjustment member (18, 20, and 22) includes an adjustment chamber therein (interior portion of inner housing 18, which provides air for entraining liquid for inhalation), the third opening (either one of openings 96 or the top opening of nozzle cover 34) communicates with the adjustment opening (when the third opening is the top opening in 34, the adjustment opening is the bottom opening in nozzle cover 34; when the third opening is 96, adjustment opening is taken as openings/channel in nozzle cover 34), and the adjustment opening (when the third opening is the top opening in 34, the adjustment opening is the bottom opening in nozzle cover 34; when the third opening is 96, adjustment opening is taken as openings/channel in nozzle cover 34) communicates with the second opening (see annotated Fig. 2 below) (paragraph 128, lines 1-2, note openings in 34 at either end; paragraph 132, lines 1-5 for detachability of housing 18 on 14; paragraph 137 and Fig. 3A for operation of the device and airflows during inhalation; paragraph 140, final four lines for openings 96; see also Fig. 3A, and the two end openings in nozzle cover 34; Examiner notes that the medication adjustment device is currently limited to include the liquid reservoir and the medication adjustment member, and the medication adjustment member is limited to include the series of openings and the accommodating cavity, and medication adjustment is presently construed as the entrainment of inhaled air through the device with aerosolized particles for transformation from liquid to aerosol for inhalation).
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Regarding claim 2, Costella discloses the medication adjustment device according to claim 1, as discussed above.
Costella further discloses wherein the adjustment opening (in this case, openings/channel in nozzle cover 34) is a cylindrical opening that includes a first port and a second port (paragraph 128, lines 1-4; Fig. 3A), the first port penetrates a bottom of the medication adjustment member (18, 20, and 22), and the second port extends toward the third opening (in this case, openings 96) (se Figs. 2-3A, where the second port, taken as the top opening in 34 extends towards 96, and first port, taken as the bottom opening in 34 penetrates the bottommost part of 18).
Regarding claim 3, Costella discloses the medication adjustment device according to claim 2, as discussed above.
Costella further discloses wherein the adjustment chamber (interior portion of inner housing 18, which provides air for entraining liquid for inhalation) is formed between a first peripheral wall of the adjustment opening (in this case, nozzle cover 34) and a second peripheral wall of the medication adjustment member (18, 20, and 22) (see annotated Fig. 3A below).
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Regarding claim 4, Costella discloses the medication adjustment device according to claim 2, as discussed above.
Costella further discloses wherein the medication adjustment member (18, 20, and 22) further includes a first annular portion and a second annular portion (34) (see annotated Fig. 2 below), the second annular portion (34) is located below the first annular portion (see annotated Fig. 2 below), the first annular portion is disposed around an outer periphery of the third opening (96) (see annotated Fig. 2 below, and note that the identified first annular portion overhangs the outer periphery of 96), and the second annular portion (34) is disposed around an outer periphery of the adjustment opening (in this case, openings/channel in nozzle cover 34) (paragraph 128, lines 1-4; Fig. 3A).
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Regarding claim 5, Costella discloses the medication adjustment device according to claim 4, as discussed above.
Costella further discloses a sealing member (88), wherein the sealing member (88) is surroundingly disposed outside the second annular portion (see annotated Fig. 2 for second annular portion, and note that in Figs. 2 and 3A, 88 surrounds openings within diaphragm 20 and housing 16 that contains 34, and is disposed outside, i.e. above, of the area in which 34 is contained).
Regarding claim 7, Costella discloses the medication adjustment device according to claim 2, as discussed above.
Costella further discloses a cover (16), wherein the cover (16) is disposed on the liquid reservoir (14 containing 46 and covers the first opening and the third opening (paragraph 133, lines 1-8; Figs. 1-3A, note that 16 covers the opening of 14, and in so doing also covers additional openings 96 and the channel 34).
Regarding claim 9, Costella discloses the medication adjustment device according to claim 1, as discussed above.
Costella further discloses wherein the medication adjustment member (18, 20, and 22) further includes a side wall (see wall of 34) and a bottom wall (see annotated Fig. 3A), the side wall (see wall of 34) has a first side and a second side that are opposite to each other (see either top/bottom end of 34 as first and second sides), the adjustment opening (top opening in nozzle cover 34) is formed on the first side, and the bottom wall is tilted downward from the first side to the second side (see tilted arrangement of bottom wall in Fig. 3A, and note the downward tilt along the length of 34 from the top to bottom).
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Regarding claim 10, Costella discloses the medication adjustment device according to claim 9, as discussed above.
Costella further discloses wherein the side wall and the bottom wall jointly form the adjustment chamber (see annotated Fig. 3A below).
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Regarding claim 13, Costella discloses the medication adjustment device according to claim 9, as discussed above.
Costella further discloses a cover (16), wherein the cover (16) is disposed on the liquid reservoir (14 containing 46 and covers the first opening and the third opening (paragraph 133, lines 1-8; Figs. 1-3A, note that 16 covers the opening of 14, and in so doing also covers additional openings 96 and the channel 34).
Regarding claim 15, Costella discloses the medication adjustment device according to claim 1, as discussed above.
Costella further discloses a nebulizing module (24, 28, 30, and pressurized gas source) disposed inside the liquid reservoir (14 including 46), wherein the nebulizing module (24, 28, 30, and pressurized gas source) is located at a connection position between the second opening and the accommodating cavity (see interior of 18 in Fig. 3A) (see paragraphs 127 and 130-131, and note in Fig. 3A, the nebulizing module is located between the right interior side of 18 and the second opening aligned with the mouthpiece and connected to 18).
Allowable Subject Matter
Claims 6, 8, 11-12, and 14 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.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding the instant invention, the closest prior art of record identified is Zachar (US 2024/0215639), Yang (WO 2023/236802), Liu (CN 113694320), Patton (US 2021/0228824), and Silvesstrini (US 2018/0242642). Notably, Zachar includes a series of chambers for metering the liquid (see Figs. 9A-B, 21A-B, and 26A-B), but as the device is unitary, the adjustment member is not reasonably detachable. In Yang, the top portion 20 is described as detachable, and as seen in Figure 20, this top portion includes a liquid reservoir with multiple openings. However, Yang does not convey that the medication adjustment member detaches from a first opening. While Liu includes the liquid reservoir, and shows it to detach in Figure 1, there is not an analogous medication adjustment member. Patton shows refilling of a liquid reservoir manually at Figures 2-3, and an annular shaped member for holding the liquid, but this empties directly into a nebulizing module without an analogous medication adjustment member. Silvesstrini’s Figure 2A shows a liquid reservoir with two additional, smaller changes for compartmentalizing doses, but does not include detachment of the medication adjustment member at a first opening. Thus, since Costella does not contemplate the subject matter of claims 6, 8, 11-12, and 14, and none of the additional references even contemplate the subject matter of claim 1, claims 6, 8, 11-12, and 14 would be allowed if written in independent form to include any base and intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAIGE BUGG whose telephone number is (571)272-8053. The examiner can normally be reached Monday-Friday 9-5.
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/PAIGE KATHLEEN BUGG/Primary Examiner, Art Unit 3785
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