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 .
Response to Amendment
This office action is in response to the amendment filed 7/20/2026. As directed by the amendment, claims 1, 3, 4, 8-11, 16 and 17 have been amended. Claims 1-20 are pending in the instant application, wherein claims 12-15 and 18-20 remain withdrawn in response to restriction.
Applicant has amended the title to be more descriptive; the objection to the specification is withdrawn.
Applicant has amended the claims to address minor informalities; the objections to the claims are withdrawn.
Applicant has amended claim 8 to provided antecedent basis; the rejection of claim 8 under 35 USC 112(b)/second paragraph is withdrawn.
Response to Arguments
Applicant's arguments filed 7/20/2026 (hereinafter “Remarks) have been fully considered but they are not persuasive.
Regarding claim 1, Applicant argues on page 9 of Remarks that “Toma’s detour path repeatedly folds back the powder/airflow between folding surfaces 5a and 5b and into introduction hole 6,” concluding that “Toma does not teach [a gap as claimed].”
The Examiner fails to see how the amended claims exclude the folded airflow path of Toma. Toma has a gap and intermediate portion as claimed, see the modified Fig. in the updated rejection below; therefore, claim 1 remains rejected in view of the prior art.
Regarding claim 6, Applicant argues on pages 10-11 of Remarks that Toma’s conical shape “fits into the inclined surface 6a of introduction hole 6 and cooperates with first and second folding surfaces 5a and 5b to guide, fold back, disperse, and atomize powder through Toma’s detour path,” asserting that “[m]odifying portion 113b into a cylinder…would alter Toma’s intended detour-path structure” and that “Gupte’s impact plate is used in a different separator arrangement and does not provide a sufficient reason to modify Toma’s specifically configured raised portion 113b in a manner that would alter Toma’s intended powder-guiding structure.”
The Examiner disagrees that squaring off the shape 113b of Toma would alter the detour path or the powder-guiding structure in a way that would render it unsuitable for its intended purpose: the path would be substantially the same, just not as rounded in the end region of 113b. In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. (emphasis added) See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Gupte is provided as a general teaching 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), and the Examiner maintains 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 more 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, while retaining the folded path of Toma. Applicant has not provided any objective evidence that the proposed modification could not be achieved by an artisan or would render Toma unsuitable for its intended purpose; therefore, the rejection of claim 6 is maintained below.
Regarding claim 11, Applicant argues on page 11 of Remarks that Toma does not teach a gap as claimed and that “Gupte does not cure this deficiency.”
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Toma does disclose a gap as claimed, see the updated rejection below, and Gupte teaches a suitable diameter/spacing for a gap between a blocker and a tube, such that the combination of references renders the limitations of claim 11 obvious as maintained below.
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 1-11, 16 and 17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1 (and thus its dependent claims 2-11, 16 and 17), it is unclear what is meant by “the gap configured to redirect the airflow coaxially towards a centrally arranged discharge portion” in the last two lines of claim 1. Coaxially…relative to what? And is the “centrally arranged discharge portion” the same or different from the discharge portion of line 15? Looking to the instant specification, the intermediate portion 222/gap 224 seen in Fig. 4A is described in the middle of page 4, page 11 Ex. 6, and from the top of page 20 to the top of page 21 as “extend[ing] radially inward from the off-set portion” (emphasis added), such that airflow therethrough would similarly be radially. Therefore, as best understood and for purposes of compact prosecution, since it appears claim 1 was intended to describe the intermediate portion 222/gap 224 of instant Fig. 4A, in order to address this rejection and accurately describe this feature in a clear manner that is supported by the specification as originally filed, claim 1, lines 14-18, could be amended to read (and will be interpreted as encompassing) “an airflow channel comprising…an off-set portion…extending through a gap towards a centrally-arranged discharge portion…the gap configured to redirect the airflow radially towards the centrally-arranged discharge portion.”
Regarding claim 11, line 1 recites “a gap,” wherein it is unclear in the claim whether this is the same gap as amended claim 1 or a different gap. As best understood, for purposes of examination, they are the same gap, such that Applicant could address this rejection by amending claim 11, line 1 to read “the gap”.
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. 7, 8 and 10) comprising:
an inhaler body (body 120) comprising a tubular side wall (cylindrical portion 121) defining an interior (Figs. 7 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. 7-8);
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. 7 and 10),
the mouthpiece element comprising:
a tube (comprising introduction hole 6) extending coaxially with the inhaler body (Figs. 7 and 10) and comprising an interior surface (comprising surface 6a) having a first diameter (any inner diameter of hole 6) (Figs. 7 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. 7 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. 7] of the blocker (Figs. 7 and 10), the ring defining an inner diameter (defined by hole 6) and an outer diameter (defined by outer cylindrical part 114a) (Figs. 7 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. 7 in view of Fig. 2), extending through a gap (comprising the right portion of detour 5) towards a [centrally arranged] discharge portion (within hole 6) extending to an outlet (the bottom of hole 6 in Fig. 10 OR port 131) at the proximal end (see Fig. 7 in view of Fig. 2), the gap forming an intermediate portion (comprising the space between surface 5a and surface 5b) connecting the off-set portion and the discharge portion (see Fig. 7 in view of Fig. 2, e.g. Fig. 2 modified below), the gap configured to redirect the airflow coaxially [as well as radially] toward [the] centrally arranged discharge portion (see Fig. 7 in view of Fig. 2, e.g. Fig. 2 modified below, where the airflow is redirected radially at the right and left ends of detour 5 and coaxially (relative to the mouthpiece element) along the length of detour 5 and as the air flows into hole 6).
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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. 7 and 10).
Regarding claim 3, Toma discloses the inhaler article of claim 1, further comprising a capsule (capsule C) containing the inhalable powder disposed in the receptacle (Fig. 7-8; 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 element 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. 7 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. 7] to at least a portion [to the right in Fig. 8] of the tube (6) (Fig. 7).
Regarding claim 8, as best understood, Toma discloses the inhaler article of claim 1, wherein the mouthpiece element comprises a tubular mouthpiece side wall (comprising cylindrical part 114a), wherein the collector surface (5a) extends from the tube (6) to the tubular mouthpiece side wall (114a) (Figs. 7 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. 7 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. 7 and 10).
Regarding claim 16, Toma discloses the inhaler article of claim 2, further comprising a capsule (capsule C) containing the inhalable powder disposed in the receptacle (Fig. 7-8; 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 element 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. 7 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, but Toma is silent regarding specific dimensions of the detour 5, such that Toma is silent regarding wherein, as best understood, [the] gap has a distance of 1 mm to 5 mm between the blocker and the tube. 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
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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, Tu-Th 8a-2p, F 7:30-11:30a 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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