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 .
Election/Restrictions
Applicant's election with traverse of Species A, claims 1-11, 16 and 17 in the reply filed on 2/24/2026 is acknowledged. The traversal is on the ground(s) that a) the Office Action “maps Pavkov’s element 10 to both the claimed “tube” and a different claimed structure (“collector surface”)…reliance on the same Pavkov element to satisfy multiple, separately recited claim components underscores that Pavkov lacks these features,” b) element 10 is “not [] a tubular conduit defining an interior diameter or an internal collection surface [note: the instant claims do not recite an “internal” collection surface]…support/retaining ring is structurally and functionally distinct from a tube extending coaxially with the inhaler body and from a collector surface,” c) the object 4 does not comprehend a blocker “having a second diameter that is greater than the first diameter,” d) Altounyan does not “provide [] disclosure of a collector surface configured to collect particles…[or e)] teach or suggest a blocker that is coaxial with a tube and has “a second diameter that is greater than the first diameter.”
These arguments are not found persuasive because a) the claims do not stipulate the location of the collector surface as on a component separate and distinct from the tube, and the (unelected) embodiment of instant Claims 6A-C (with claim 1 acknowledged by Applicant on page 1 of Remarks as generic to this embodiment) depicts collector surface 350 on/as a surface of tube 340, such that interpreting element 10 of Pavkov as reading on the claimed tube and also comprising the collector surface is not a lack in Pavkov, and indeed, it is in line with the instant specification, b) the ring 10 of Pavkov is clearly a tubular conduit that extends coaxially with the body (housing 2) and defines an interior diameter, and the right surface of said ring/tubular conduit (see modified Fig. 3A below) comprehends a collection surface in as far as material is fully capable of collecting thereon as shelf that redirects flow in the same way as e.g. the collector surface 350 on tube 340 of instant Figs. 6A-C serves this purpose, and the Examiner notes that claim 1 does not require the tube to “extend…from a collector surface” as asserted by Applicant, such that Pavkov need not disclose this limitation to anticipate claim 1, c) element 4 of Pavkov does indeed have a second diameter greater than the first, see Fig. 3A modified below, where the outer base diameter of element 4 is clearly larger than the inner diameter of element 10, d) the upper surface of the tube/ring 34 of Altounyan Fig. 7 comprehends a collection surface in as far as material is fully capable of collecting thereon when airflow is redirected by the struts 33 to flow up and over said upper surface of the ring, and e) skirt 36 is clearly coaxial with and has a larger outer diameter than the inner diameter of tube/ring 34 in Altounyan Fig. 7 and blocks air from passing through the center where skirt 36 is located. Moreover, it is noted that the full search conducted after election revealed the prior art of Toma, applied in the rejections below as the closest prior art to the elected species, which further demonstrates that the elements of claim 1 are not technical elements that define over the prior art.
The requirement is still deemed proper and is therefore made FINAL.
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Claims 12-15 and 18-20 [because claim 18 is drawn to a non-supported combination of the recessed portion of Species B with the collector surface of claim 8/species A, see claim 8 interpretation in light of the 112(b) issue therein, below] are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 2/24/2026.
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
The following title is suggested: INHALER ARTICLE AND LEAKAGE-PREVENTING MOUTHPIECE FOR USE WITH THE SAME.
Claim Objections
Claims 9 and 10 are objected to because of the following informalities:
Claims 9 and 10 should read “cross-sectional”, that is, a dash included between the terms ‘cross’ and ‘sectional’
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.
Claim 8 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 8 recites the limitation "the side wall" in line 2. There is insufficient antecedent basis for this limitation in the claim, because the specification as originally filed does not support interpreting the side wall of claim 8 as the “tubular side wall” (emphasis added) of the inhaler body of claim 1; rather, e.g. instant Fig. 4A makes it clear that the surface collector (250) that “extends from the tube” extends from the tube (240) to the side wall (203) of the mouthpiece element, which is understood to correspond to the “cylindrical side wall” of claim 5. Therefore, for purposes of examination, claim 8 will be considered to depend on claim 5 and to read “the cylindrical side wall”.
Claim Interpretation
The functionality of claims 4 and 16 is understood to be provided by a surface that has an upturned lip when positioned as claimed, see the lip formed by the surface 250 transitioning into tube 240 in instant Fig. 3C or the curvature of surface 350 as it curves towards openings 312 in instant Fig. 6C.
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.
Claim(s) 1-5, 7-10, 16 and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Toma (JP 2011-212252 A; hereinafter “Toma”).
Regarding claim 1, Toma discloses an inhaler article (inhalation device 100) (Figs. 8 and 10) comprising:
an inhaler body (body 120) comprising a tubular side wall (cylindrical portion 121) defining an interior (Figs. 8 and 10) and a longitudinal center axis (central axis O), the interior forming a receptacle (the chamber in which part 111 is located) for housing an inhalable powder (within capsule C) (Fig. 8);
a mouthpiece element (comprising mouthpiece 130+parts 113 and 114) extending along the longitudinal center axis from a distal end (comprised by part 113) to a proximal end (comprising by part 130), the distal end of the mouthpiece element being received in the interior of the inhaler body (Figs. 8 and 10),
the mouthpiece element comprising:
a tube (comprising introduction hole 6) extending coaxially with the inhaler body (Figs. 8 and 10) and comprising an interior surface (comprising surface 6a) having a first diameter (any inner diameter of hole 6) (Figs. 8 and 10);
a blocker (the solid center of part 113 comprising portion 113b) disposed at the distal end of the mouthpiece element, coaxial with the tube and having a second diameter (e.g. extending between grooves 113a) that is greater than the first diameter (Figs. 8 and 10), the blocker being arranged to block airflow through a center of the mouthpiece element at the distal end (see e.g. Fig. 2, where airflow is blocked from going through the center/must go around the solid center of part 113 comprising portion 113b);
a collector surface (surface 5a) [where the surface 5a comprehends a collection surface in as far as material is fully capable of collecting thereon because it is surface that redirects flow in the same way as the collector surface 250 of instant Figs. 3A-C] comprising a ring that is coaxial with and disposed proximally [to the left in Fig. 8] of the blocker (Figs. 8 and 10), the ring defining an inner diameter (defined by hole 6) and an outer diameter (defined by outer cylindrical part 114a) (Figs. 8 and 10); and
an airflow channel extending through the mouthpiece element and comprising an off-set portion (through grooves 113a) arranged around the blocker (see Fig. 8 in view of Fig. 2), a discharge portion (through hole 6) extending to an outlet (the bottom of hole 6 in Fig. 10 OR port 131) at the proximal end (see Fig. 8 in view of Fig. 2), and an intermediate portion (between surface 5a and surface 5b) connecting the off-set portion and the discharge portion (see Fig. 8 in view of Fig. 2).
Regarding claim 2, Toma discloses the inhaler article of claim 1, wherein the tube (6) defines an outlet (lower opening of tube 6 in Fig. 10 OR port 131 if the tube is considered to comprise hole 6 as well as the mouthpiece part 130) at the proximal end of the mouthpiece element (Figs. 8 and 10).
Regarding claim 3, Toma discloses the inhaler article of claim 1, further comprising a capsule (capsule C) containing inhalable powder disposed in the receptacle (Fig. 8; abstract).
Regarding claim 4, Toma discloses the inhaler article of claim 1, wherein the collector surface (5a) is configured to collect any loose powder within the inhaler body when the inhaler article is turned upside down such that the proximal end of the mouthpiece points downward (Fig. 10), because the surface 5a transitions via an upward lip into tube 6, the same as instant Fig. 3C.
Regarding claim 5, Toma discloses the inhaler article of claim 1, wherein the mouthpiece element comprises a cylindrical side wall (comprising cylindrical part 114a) extending from the proximal end to the distal end and circumscribing the tube (Figs. 8 and 10).
Regarding claim 7, Toma discloses the inhaler article of claim 1, wherein the collector surface (5a) is disposed proximal [to the left in Fig. 8] to at least a portion [to the right in Fig. 8] of the tube (6) (Fig. 8).
Regarding claim 8, as best understood, Toma discloses the inhaler article of claim [5], wherein the collector surface (5a) extends from the tube (6) to the [cylindrical] side wall (114a) (Figs. 8 and 10).
Regarding claim 9, Toma discloses the inhaler article of claim 1, wherein the collector surface (5a) comprises a curved cross sectional shape in a cross section taken along the longitudinal center axis of the mouthpiece element (Figs. 8 and 10).
Regarding claim 10, Toma discloses the inhaler article of claim 9, wherein the curved cross sectional shape is concave toward the distal end of the mouthpiece element (Figs. 8 and 10).
Regarding claim 16, Toma discloses the inhaler article of claim 2, further comprising a capsule (capsule C) containing inhalable powder disposed in the receptacle (Fig. 8; abstract).
Regarding claim 17, Toma discloses the inhaler article of claim 16, wherein the collector surface (5a) is configured to collect any loose powder within the inhaler body when the inhaler article is turned upside down such that the proximal end of the mouthpiece points downward (Fig. 10), because the surface 5a transitions via an upward lip into tube 6, the same as instant Fig. 3C.
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 nonobviousness.
Claim(s) 6 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Toma in view of Gupte et al. (US 5,676,130; hereinafter “Gupte”).
Regarding claim 6, Toma discloses the inhaler article of claim 1, wherein Toma further discloses wherein the blocker comprises an elongated three-dimensional shape (i.e. the rounded conical shape of portion 113b) coaxial with the longitudinal center axis of the mouthpiece element (Figs. 8 and 10), but Toma is silent regarding the shape being a cylinder. However, a change in shape is generally recognized as being within the level of ordinary skill in the art, see MPEP 2144.04.IV.B, and Gupte teaches that it was known in the art before the effective filing date of the claimed invention for a blocker (impact plate 6) to comprise either rounded surfaces as taught by Toma (e.g. Gupte Fig. 5) or straight/angular surfaces (e.g. Gupte Fig. 4), such that it would have been obvious to an artisan before the effective filing date of the claimed invention for portion 113b of Toma to be in the shape of a cylinder as claimed, in order to provide the predictable result of shape that is easily and/or repeatably machined or formed, e.g. one that can be formed into part 113 of Toma via a standard cylindrical drill bit.
Regarding claim 11, Toma discloses the inhaler article of claim 1, wherein Toma further discloses wherein a gap between the blocker and the tube has a distance (Fig. 8), but Toma is silent regarding specific dimensions, such that Toma is silent regarding the gap having a distance of 1 mm to 5 mm. However, a change in size is generally recognized as being within the level of ordinary skill in the art, see MPEP 2144.04.IV.A, optimization of ranges of parameters within prior art ranges or through routine experimentation is not sufficient to patentably distinguish the invention over the prior art, see MPEP § 2144.05, and Gupte teaches that it was known in the art before the effective filing date of the claimed invention for the gap (opening 7) between a blocker (impact plate 6) and an adjacent element (wall of chamber 5) for allowing airflow therebetween (Fig. 1) to be about 2 mm (col. 2, lines 1-7). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention to modify the gap of Toma through routine experimentation and in view of the typical dimensions within an inhaler, specifically the space between blockers and adjacent elements for creating airpaths therebetween, to have a distance of 1 mm to 5 mm as taught by Gupte, in order to provide the predictable result of allowing sufficient airflow through the inhaler while ensuring that larger particles are not allowed to escape the inhaler (Gupte cols. 1-2).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Additional references regarding blockers and/or collection surfaces in inhalers: Aikman (US 4,038,994), Blount et al. (US 3,636,960); Braithwaite (US 6,347,629 B1), Hernandez et al. (US 4,049,005); Haas (US 2011/0220234 A1); Jones et al. (US 2013/0008442 A1); Mensik (US 4,292,983); Okhi et al. (US 6,595,210 B2); Thorens et al. (US 2011/0094523 A1 and US 2013/0306064 A1); Watt et al. (US 3,980,074 and US 3,888,253); Zhu (US 2013/0263869 A1).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHRYN E DITMER whose telephone number is (571)270-5178. The examiner can normally be reached M 7:30a-3:30p, T/Th 8:30a-2:30p, W 11:30a-4:30p, F 1-4p ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brandy Lee can be reached at 571-270-7410. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHRYN E DITMER/Primary Examiner, Art Unit 3785
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