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 remarks and amendments filed on 04-21-2026. As directed, claims 1-3, 9, 13, 15-16, and 19 have been amended, no claims have been canceled, and no new claims have been added. Thus, claims 1-20 are currently pending examination.
Response to Amendment
Applicant has amended each of claims 1-2, 9, and 19 to address minor informalities therein. The previously held claim objections are hereby withdrawn.
Applicant has amended each of claims 3, 15, and 16 to address indefiniteness therein. The previously held rejections of claims 3 and 15-16 under 35 USC 112b are hereby withdrawn.
Response to Arguments
Applicant argues, see bottom of page 5 of the remarks as filed through the bottom of page 6, that the relied on 103 combination of Alston and Dunne fail to disclose and/or teach the limitations of claim 1 which require “only a single aperture in the capsule, the single aperture extending through the tubular side wall” and “wherein the single aperture is disposed closer to the first end than the second end”. Applicant cites to the Office action at pages 5-6, specifically the statement that Alston does not contemplate the single aperture extending through the tubular side wall and reliance on Dunne for altering the placement of the aperture, and concludes that the Office’s findings that Alston in view of Dunne contemplate every element of claim 1 are clear error. Applicant argues this for a number of reasons outlined below.
First, Applicant argues, see remarks as filed bottom of page 6 through the top of page 8 as filed, that the rejection “improperly dissects a single integrated aperture limitation rather than addressing the claimed limitation as a whole”, further arguing that the 103 statute seeks to find whether or not the invention as a whole would be rendered obvious by prior art findings. Applicant further notes that all claimed limitations must be considered. Applicant then asserts that claim 1 does not separately set forth an aperture, a side wall, and proximity of the aperture to one end as separate ideas, but rather claim 1 limits these ideas to a single, integrated configuration, and further states that the Office action must treat these limitations as an integrated rather than separable fragments. Applicant further argues that Alston has been relied on for the disclosure of the single aperture closer to one end then the other, and separately uses Dunne to teach the aperture extending through a tubular side wall, and posits that obviousness must be determined based on the limitation as a whole, and with a reasoned explanation of why the invention would have been obvious, concluding once again that the rejection of record fragments the limitation at issue into parts rather than addressing it as a whole.
Examiner respectfully disagrees with Applicant on this point. Initially, it is correct that Alston is relied on for the disclosure that the single aperture (130) is closer to the identified first end than the second end, owing to Alston’s placement of the aperture (130) on the identified first end of the capsule (125) (paragraph 23, lines 7-10; Fig. 1A). It is also noted, in the Office action, that because Alston incorporates the aperture at the first end, Alston fails to disclose the single aperture extending through the tubular side wall, since the tubular side wall is defined as extending between the first and second ends. Dunne is relied on to cure this deficiency, providing an aperture (6) located in a tubular side wall of the capsule (1+2) (paragraph 36, lines 1-7, see cylindrical; paragraph 80, lines 1-5; Figs. 1A-C), wherein the size, position, and number of holes is variable in order to optimize the capsule structure for particular powders to be nebulized based on their flow simulations (paragraph 36, lines 7-14; note also, paragraph 13, lines 7-9, where a single aperture arrangement is contemplated). The Office action went on to conclude: it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the placement of the single aperture of the Alston capsule to be oriented in the tubular side wall closer to the first end of the capsule, given that Alston contemplates the aperture at the first end while Dunne contemplates the aperture in the side wall of its capsule, as Dunne teaches that the placement of an aperture within a capsule for dispelling inhalable powder may be variably modified in order to optimize the nebulization of the powder within the capsule.
It is further of note that Alston’s aperture (130) is located on a side of the capsule (125) opposite the opening (145) from which a user inhales, and on the same side as an airflow (155) drawn into the device, which is stated to cause movement of the capsule (125) and for medicament to exit the capsule (125) to be entrained within a user’s inhalation flow (see paragraph 25 and Figs. 1A-1C). Thus, the positioning of the opening (130) at the identified first end of the capsule (125) is retained in the rejection of record. Dunne was relied on to remedy the deficiency of Alston, and modify the capsule of Alston such that the aperture, located on the same end of the capsule, were moved to be extending through the side wall of Alston, where Dunne instructs the ordinarily skilled artisan that the size, position, and number of holes is variable in order to optimize the capsule structure for particular powders to be nebulized based on their flow simulations (paragraph 36, lines 7-14; note also, paragraph 13, lines 7-9, where a single aperture arrangement is contemplated). In other words, Dunne contemplates, and expressly teaches, that the placement, number, and size of apertures within prior art capsules used for delivering inhalable medicament can be variably provided in order to optimize the nebulization of different powdered medicaments, and further illustrates the side wall placement of one such aperture (6) in Figures 1A-C. Thus, all of the claimed limitations are addressed, and Dunne’s teachings used to modify the Alston capsule are in fact provided with a reasoned explanation as to why the placement of the aperture could be modified.
It seems as though Applicant’s principle argument here is that all of the claimed limitations are not found within a single prior art reference. This is not the standard for determining obviousness of a claimed invention. Alston contains all of the claimed limitations with the exception of the placement of the aperture in the tubular side wall, which is remedied by Dunne, Further, in response to applicant's arguments against the references individually, one cannot show non-obviousness 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). As Applicant’s arguments are unpersuasive on this point, the rejection of claim 1 employing Alston and Dunne will be maintained hereinbelow.
Second, Applicant argues that the proposed modification would defeat the purpose and operating principle of Alston’s device, stating further that if a proposed modification would render the prior art to change its operating principle, a prima facie case of obviousness cannot be rendered. Applicant then cites to Alston at paragraphs 23-25, and argues that movement of the relied upon aperture (130) would change where the airflow into the device interacts with the aperture, and thus change the mechanism by which the formulation is withdrawn from the receptacle, rendering the Alston device, when modified, unsuitable for its intended purpose.
Examiner respectfully disagrees with Applicant on this point as well. In Alston’s paragraph 25, it is purported that airflow through the device agitates the capsule (125) and a pharmaceutical formulation is able to escape the aperture (130) because of movement of the capsule (125) exacted by the airflow into the device (100). Neither in the Alston citations provided by Applicant nor in Figures 1A-C is the airflow into openings 115 shown to traverse into the capsule (125), rather the airflow is shown creating movement of the entire capsule (125) in order to dislodge medicament through the aperture (130). Further, Alston does not provide any evidence that moving the placement of the aperture (130) would disallow the escae of the pharmaceutical formulation from within the capsule (125). And further, Dunne explicitly shows an aperture (6) formed in a side wall of an analogous capsule, and contemplates the escape of medicament through the aperture (abstract, lines 1-4; paragraph 83, lines 1-6). Thus, Dunne also provides evidence that the powder medicament is able to escape the capsule through the aperture even when arranged on the analogous tubular side wall. For these reasons, it is understood that moving the aperture of the Alston device still renders the predictable result of allowing for expulsion of powdered medicament from an interior of its capsule. As Applicant’s arguments are unpersuasive on this point, the rejection of claim 1 employing Alston and Dunne will be maintained hereinbelow.
Third, Applicant argues that Dunne does not teach or suggest the claimed single side-wall aperture located closer to the first end than the second end. Applicant goes on to describe the principle of operation of one Dunne embodiment where a prefabricated hole is initially covered, and then expulsion of powder occurs when two holes are in registration to allow an opening to the outside of the capsule. Applicant additionally argues that Dunne does not provide for a single aperture, specifically citing to paragraph 80 of Dunne and its Figure 1A configuration. Applicant further argues that Dunne does not disclose wherein the first end of the aperture is oriented towards the upstream end of the body with the single aperture located closer to the first end than the second end, as is required by claim 1, stating that at beast Dunne places its aperture at the center of the capsule. Applicant concludes by stating that the placement of the aperture of the instant claims and invention improves powder delivery within the device, and that this was an unexpected result. Applicant argues that Dunne does not recognize the location-specific technical advantage described in the instant specification.
Examiner respectfully disagrees. First, as stated above Alston is relied on for the disclosure that the single aperture (130) is closer to the identified first end than the second end, owing to Alston’s placement of the aperture (130) on the identified first end of the capsule (125) (paragraph 23, lines 7-10; Fig. 1A). It is further of note that Alston’s aperture (130) is located on a side of the capsule (125) opposite the opening (145) from which a user inhales, and on the same side as an airflow (155) drawn into the device, which is stated to cause movement of the capsule (125) and for medicament to exit the capsule (125) to be entrained within a user’s inhalation flow (see paragraph 25 and Figs. 1A-1C). Thus, the positioning of the opening (130) at the identified first end of the capsule (125) is retained in the rejection of record.
Dunne was relied on to remedy the deficiency of Alston, and modify the capsule of Alston such that the aperture, located on the same end of the capsule, were moved to be extending through the side wall of Alston, where Dunne instructs the ordinarily skilled artisan that the size, position, and number of holes is variable in order to optimize the capsule structure for particular powders to be nebulized based on their flow simulations (paragraph 36, lines 7-14; note also, paragraph 13, lines 7-9, where a single aperture arrangement is contemplated). In other words, Dunne contemplates, and expressly teaches, that the placement, number, and size of apertures within prior art capsules used for delivering inhalable medicament can be variably provided in order to optimize the nebulization of different powdered medicaments, and further illustrates the side wall placement of one such aperture (6) in Figures 1A-C. Thus, all of the claimed limitations are addressed, and Dunne’s teachings used to modify the Alston capsule are in fact provided with a reasoned explanation as to why the placement of the aperture could be modified. So contrary to Applicant’s assertion, Dunne illustrates placement of an aperture on the side wall, and further provides a teaching that aperture size, number, and placement may be altered in order to affect better nebulization of the powder contained within the capsule. In other words, Dunne teaches one of ordinary skill that an arrangement of the aperture as claimed is known and contemplated, and further provides instructive advice that the aperture could be variably provided in number, size, and placement to optimize the nebulization of the medicament. Still further, in response to applicant's arguments against the references individually, one cannot show non-obviousness 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). It is the combination of Alston and Dunne that has been shown to establish obviousness, not Dunne solely. As Applicant’s arguments are unpersuasive on this point, the rejection of claim 1 employing Alston and Dunne will be maintained hereinbelow.
Fourth, Applicant argues, see remarks as filed bottom of page 12 though page 13, that Dunne would not have led a person having ordinary skill in the art to the modification required by claim 1. Applicant argues that this is because Dunne provides a different aperture formation approach than Alston. Applicant argues that Dunne’s approach eliminates the need for capsule piercing and capsule piercing means within its device. Applicant seems to argue that Alston requires a piercing means for creating the aperture, which would stand at odds with Dunne’s teachings.
Examiner respectfully disagrees. The relied upon embodiment of Alston in that shown in Figures 1A-C. In the paragraphs that refer to the aperture (130) in this particular embodiment (see paragraphs 23-25 and see Figs. 1A-C), no piercing/puncturing element is established. Notably, the Figures 4A-E embodiment of Alston does refer to a puncturing mechanism 250 (see paragraph 30). This is not the relied upon embodiment in the rejection of record. Further, Applicant provides no citation to Alston where such a piercing element is required in the relied upon embodiment, not could the Examiner find any such evidence in the Alston disclosure with respect to Figures 1A-C. As Applicant’s arguments are unpersuasive on this point, the rejection of claim 1 employing Alston and Dunne will be maintained hereinbelow.
Finally, Applicant argues, see remarks as filed page 14-17, that each of dependent claims 2-20 are patentably distinct over the prior art because of the previous allegations that the Alston and Dunne combination fail to disclose every aspect of claim 1, and further that none of Zuber, Stenzler, nor Buehler cure the alleged deficiencies of Alstom and Dunne. However, as Applicant’s arguments are regarding claim 1 have been found unpersuasive, the rejections of claims 2-20 will be maintained hereinbelow.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or non-obviousness.
Claims 1-2, 4-5, 8-9, 13, 17, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Alston (US 2004/0206350) in view of Dunne (US 2014/0182587).
Regarding claim 1, Alston discloses an inhaler article (100) (paragraph 23, lines 1-2 and 10-14; Fig. 1A) comprising:
a body (105) comprising an upstream end and a downstream end (paragraph 23, lines 3-5; see annotated Fig. 1A below), a capsule receptacle (110), and an airflow path extending from the capsule receptacle (110) to an opening (145) at the downstream end (paragraph 23, lines 3-5 and 10-14; paragraph 25, lines 1-4, see arrows 155 and 160; Fig. 1A); and
a capsule (125) disposed inside the capsule receptacle (110) (paragraph 23, lines 5-7; paragraph 22, lines 1-4; Fig. 1A), the capsule (125) comprising:
a first end and a second end (see annotated Fig. 1A below);
a tubular side wall extending between the first and second ends (see annotated Fig. 1A below for first and second ends; see Figs. 1A-C for the lateral dimension of the capsule 125, and Figs. 2A-B for the circular cross-section, given that the cross-section is circular, and the capsule extends into the plane of the page in Figs. 2A-B, the capsule is regarded as tubular, and the tubular side wall is defined as the circular boundary of the capsule extending form the first end to the second end);
only a single aperture (130) in the capsule (125) (paragraph 23, lines 7-10; Fig. 1A); and
an inhalable powder disposed inside the capsule (125) (paragraph 23, lines 7-10; paragraph 22, lines 4-8),
wherein the first end of the capsule (125) is oriented toward the upstream end of the body, and wherein the single aperture (130) is disposed closer to the first end than the second end (see annotated Fig. 1A below, where the first end of the capsule coincides with the upstream end, and the single aperture 130 is disposed at the first end and is therefore closer to the first end than the second end).
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Because Alston incorporates the aperture at the first end, Alston fails to disclose the single aperture extending through the tubular side wall, since the tubular side wall is defined as extending between the first and second ends.
However, Dunne teaches a capsule (1+2) for an inhaler article (abstract, lines 1-4; paragraph 80, lines 1-3; Fig. 1A), wherein an aperture (6) is located in a tubular side wall of the capsule (1+2) (paragraph 36, lines 1-7, see cylindrical; paragraph 80, lines 1-5; Figs. 1A-C), wherein the size, position, and number of holes is variable in order to optimize the capsule structure for particular powders to be nebulized based on their flow simulations (paragraph 36, lines 7-14; note also, paragraph 13, lines 7-9, where a single aperture arrangement is contemplated).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the placement of the single aperture of the Alston capsule to be oriented in the tubular side wall closer to the first end of the capsule, given that Alston contemplates the aperture at the first end while Dunne contemplates the aperture in the side wall of its capsule, as Dunne teaches that the placement of an aperture within a capsule for dispelling inhalable powder may be variably modified in order to optimize the nebulization of the powder within the capsule.
Regarding claim 2, Alston in view of Dunne disclose the inhaler article of claim 1, as discussed above.
Alston further discloses wherein each of the first end and the second end comprises a hemisphere (refer to annotated Fig. 1A above for the first and second ends; note in Fig. 1A, the first and second ends are half circles, and thus hemispherical).
Regarding claim 4, Alston in view of Dunne disclose the inhaler article of claim 1, as discussed above.
Modified Alston fails to explicitly disclose wherein the single aperture is within 2 mm to within 10 mm of the first end as measured along a longitudinal axis of the capsule.
However, Dunne teaches that the position of the aperture in the capsule is “very variable” in its design in order to produce optimized aperture structures in the capsule relative to a particular powder encased within the capsule (paragraph 36, lines 7-14).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the placement of the single aperture of modified Alston to be within 2 mm to within 10 mm of the first end as measured along a longitudinal axis of the capsule, given that Dunne teaches that optimized nebulization of different preparations and/or powders can be accommodated by varying the position of the aperture. Further, given that Applicant places no criticality on the claimed range, stating only that the single aperture may be positioned in the given range without supporting evidence as to why the range is necessary or produces an unexpected result (page 2, line 32-page 3, line 4; page 9, lines 4-9; page 12, lines 13-15; and page 15, lines 8-12), the courts have concluded that “”[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); MPEP 2144.05.II). In this case, Dunne teaches the ordinarily skilled artisan that modifying the aperture position can be used to routinely optimize the nebulization of powder within a capsule. Thus, finding the workable ranges for optimizing the powder nebulization is not inventive, given Dunne’s teaching.
Regarding claim 5, Alston in view of Dunne disclose the inhaler article of claim 1, as discussed above.
Presently modified Alston fails to disclose wherein the single aperture has an area of 0.2 mm2 to 1.5 mm2.
However, Dunne further teaches an aperture area of 0.196 mm2 to 1.766 mm2 (paragraph 117, lines 7-10, where the range of hole diameter of 0.5-1.5 mm, using the area of a circle as A=(pi)r2, results in an area of roughly 0.196 mm2 to 1.766 mm2, where the respective radii are 0.25 mm and 0.75 mm).
In the case where the range taught in the prior art overlaps or lies inside of that of the claim, a prima facie case of obviousness exists (see MPEP 2144.05.I, and In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have chosen aperture areas in the range of 0.196 mm2 to 1.766 mm2, as taught by Dunne, as a known area size for the aperture within a capsule for dispersion of powder with a reasonable expectation of success. This range overlaps that which is claimed, and is therefore prima facie obvious.
Regarding claim 8, Alston in view of Dunne disclose the inhaler article of claim 1, as discussed above.
Alston further discloses wherein the inhalable powder comprises flavor particles (paragraph 45, lines 1-2).
Regarding claim 9, Alston in view of Dunne disclose the inhaler article of claim 1, as discussed above.
Alston further discloses wherein the capsule (125) is a polymeric capsule (paragraph 31, lines 12-13).
Regarding claim 13, Alston in view of Dunne disclose the inhaler article of claim 1, as discussed above.
Alston further discloses wherein the upstream end of the body (105) forms a distal end of the capsule receptacle (110) (see Fig. 1A, and its annotated version above, where the distal end of the chamber 110 can be defined as the area of the chamber 110 disposed distal to opening 145, which is situated at the upstream end of the body 105).
Regarding claim 17, Alston in view of Dunne disclose the inhaler article of claim 2, as discussed above.
Modified Alston fails to explicitly disclose wherein the single aperture is within 2 mm to within 10 mm of the first end as measured along a longitudinal axis of the capsule.
However, Dunne teaches that the position of the aperture in the capsule is “very variable” in its design in order to produce optimized aperture structures in the capsule relative to a particular powder encased within the capsule (paragraph 36, lines 7-14).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the placement of the single aperture of modified Alston to be within 2 mm to within 10 mm of the first end as measured along a longitudinal axis of the capsule, given that Dunne teaches that optimized nebulization of different preparations and/or powders can be accommodated by varying the position of the aperture. Further, given that Applicant places no criticality on the claimed range, stating only that the single aperture may be positioned in the given range without supporting evidence as to why the range is necessary or produces an unexpected result (page 2, line 32-page 3, line 4; page 9, lines 4-9; page 12, lines 13-15; and page 15, lines 8-12), the courts have concluded that “”[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); MPEP 2144.05.II). In this case, Dunne teaches the ordinarily skilled artisan that modifying the aperture position can be used to routinely optimize the nebulization of powder within a capsule. Thus, finding the workable ranges for optimizing the powder nebulization is not inventive, given Dunne’s teaching.
Regarding claim 19, Alston in view of Dunne disclose the inhaler article of claim 2, as discussed above.
Alston further discloses wherein the capsule (125) is hydroxypropyl methylcellulose (paragraph 31, lines 9-11).
Claims 3 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Alston (US 2004/0206350) in view of Dunne (US 2014/0182587), as applied to claims 1-2 above, in further view of Zuber (WO 2019/003118).
Regarding claim 3, Alston in view of Dunne disclose the inhaler article of claim 1, as discussed above.
While Alston illustrates that the capsule receptable diameter is larger than the capsule diameter (see Figs. 2A-B), modified Alston fails to explicitly disclose wherein the capsule receptacle has a diameter that is up to 25% greater than the capsule diameter.
However, Zuber teaches a capsule cavity and a capsule, wherein the outer diameter of the capsule is within 80%-99% of the inner diameter of the capsule cavity, and specifically wherein the capsule outer diameter is 5.85 mm and the cavity inner diameter is 6.6 mm (page 18, line 28-page 19, line 3), where 6.6/5.85=1.13, or the receptacle diameter is 13% larger than the capsule diameter.
Given that the claim, as interpreted above, requires the receptacle diameter to be no more than 25% greater than the capsule diameter, and in Zuber’s example, the receptacle diameter is 13% larger than the capsule diameter, and thus is a specific example within the claimed range, the range is anticipated (see MPEP 2131.03.I).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the capsule receptacle diameter and the capsule diameter of Alston to be 6.6 mm and 5.85 mm respectively, as taught by Zuber, as known and functional dimensions for a capsule receptacle and its associated capsule, where the receptacle is still larger than the capsule as required by Alston’s Figures 2A-B.
Regarding claim 16, Alston in view of Dunne disclose the inhaler article of claim 2, as discussed above.
While Alston illustrates that the capsule receptable diameter is larger than the capsule diameter (see Figs. 2A-B), modified Alston fails to explicitly disclose wherein the capsule receptacle has a diameter that is up to 25% greater than the capsule diameter.
However, Zuber teaches a capsule cavity and a capsule, wherein the outer diameter of the capsule is within 80%-99% of the inner diameter of the capsule cavity, and specifically wherein the capsule outer diameter is 5.85 mm and the cavity inner diameter is 6.6 mm (page 18, line 28-page 19, line 3), where 6.6/5.85=1.13, or the receptacle diameter is 13% larger than the capsule diameter.
Given that the claim, as interpreted above, requires the receptacle diameter to be up to 25% greater than the capsule diameter, and in Zuber’s example, the receptacle diameter is 13% larger than the capsule diameter, and thus is a specific example within the claimed range, the range is anticipated (see MPEP 2131.03.I).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the capsule receptacle diameter and the capsule diameter of Alston to be 6.6 mm and 5.85 mm respectively, as taught by Zuber, as known and functional dimensions for a capsule receptacle and its associated capsule, where the receptacle is still larger than the capsule as required by Alston’s Figures 2A-B.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Alston (US 2004/0206350) in view of Dunne (US 2014/0182587), as applied to claim 1 above, in further view of Stenzler (US 2018/0093050).
Regarding claim 6, Alston in view of Dunne disclose the inhaler article of claim 1, as discussed above.
Modified Alston fails to disclose wherein the inhalable powder comprises nicotine.
However, Stenzler teaches a dry powder inhaler (10) including a capsule (30) (paragraph 27, lines 1-12; Fig. 1), wherein one example of the inhalable powder within the capsule (30) is nicotine (paragraph 11, lines 1-3), and inhalation of nicotine reducing the hazardous effects of smoking (paragraph 2, lines 1-3).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the inhalable powder as nicotine, as taught by Stenzler, as a known compound that can be predictably dispensed from a capsule for inhalation, and reduce the hazardous effects of smoking while still providing the capability of ingesting nicotine.
Claims 7, 11-12, 18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Alston (US 2004/0206350) in view of Dunne (US 2014/0182587), as applied to claim 1 above, in further view of Buehler (WO 2018/220476).
Regarding claim 7, Alston in view of Dunne disclose the inhaler article of claim 1, as discussed above.
Modified Alston fails to disclose wherein the inhalable powder comprises nicotine particles with a mass median aerodynamic diameter particle size of 0.5-10 micrometers.
However, Buehler teaches an inhaler article (200) including a capsule (201) for dispensing powder comprising nicotine particles, wherein the nicotine particles have a mass median aerodynamic diameter particle size of 1-5 micrometers (Fig. 1; page 18, lines 15-19; claim 9, lines 1-3).
In the case where the range disclosed or taught by the prior art lies within the claimed range, the range is considered prima facie obvious (se MPEP 2144.05.I, and In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)).
Therefore, it would have been obvious to one of ordinary skill in the art to have provided the inhalable powder as nicotine, as taught by Buehler, as a known compound that can be predictably dispensed from a capsule for inhalation, and to have further provided the MMAD of the nicotine particles in the range of 1-5 micrometers, which lies within the claimed range and is therefore considered prima facie obvious.
Regarding claim 11, Alston in view of Dunne disclose the inhaler article of claim 1, as discussed above.
Modified Alston fails to disclose wherein the body is constructed of cellulosic material.
However, Buehler teaches an inhaler article (200) including a capsule (201) for dispensing powder comprising nicotine particles (page 18, lines 15-19), wherein the body of the device is formed of a cellulosic material which may be biodegradable (page 3, lines 27-30).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the body of the modified Alston inhaler article to be comprised of a cellulosic material, as taught by Buehler, as a known material for fabricating the inhaler article body from that may also be biodegradable.
Regarding claim 12, Alston in view of Dunne disclose the inhaler article of claim 1, as discussed above.
Alston discloses wherein the body (105) comprises a tubular member (see Figs. 2A-B).
Modified Alston fails to disclose wherein the tubular member is constructed of cellulosic material.
However, Buehler teaches an inhaler article (200) including a capsule (201) for dispensing powder comprising nicotine particles (page 18, lines 15-19), wherein the body of the device is formed of a cellulosic material which may be biodegradable (page 3, lines 27-30).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the tubular member of the body of the modified Alston inhaler article to be comprised of a cellulosic material, as taught by Buehler, as a known material for fabricating the inhaler article body from, that may also be biodegradable.
Regarding claim 18, Alston in view of Dunne disclose the inhaler article of claim 1, as discussed above.
Modified Alston fails to disclose wherein the inhalable powder comprises nicotine salt.
However, Buehler teaches an inhaler article (200) including a capsule (201) for dispensing powder comprising nicotine particles (page 18, lines 15-19), wherein nicotine is defined as including nicotine salts (page 3, lines 7-8).
Therefore, it would have been obvious to one of ordinary skill in the art to have provided the inhalable powder as nicotine salts, as taught by Buehler, as a known compound that can be predictably dispensed from a capsule for inhalation.
Regarding claim 20, Alston in view of Dunne disclose the inhaler article of claim 1, as discussed above.
Alston discloses wherein the body (105) comprises a tubular member (see Figs. 2A-B).
Modified Alston fails to disclose wherein the tubular member of the body is constructed of paper.
However, Buehler teaches an inhaler article (200) including a capsule (201) for dispensing powder comprising nicotine particles (page 18, lines 15-19), wherein the body of the device is formed of paper which may be biodegradable (page 3, lines 27-30).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the body of the modified Alston inhaler article to be comprised of paper, as taught by Buehler, as a known material for fabricating the inhaler article body from that may also be biodegradable.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Alston (US 2004/0206350) in view of Dunne (US 2014/0182587), as applied to claim 1 above, in further view of Zuber (US 2018/0369517).
Regarding claim 10, Alston in view of Dunne disclose the inhaler article of claim 1, as discussed above.
Modified Alston fails to disclose wherein the capsule is a size 1 to a size 4 capsule.
However, Zuber teaches an inhale article (1) for the inhalation of nicotine, wherein the capsule is chosen to be a size 3 capsule (paragraph 24, lines 1-14; paragraph 58, lines 1-9; Fig. 1 note MPEP 2131.03, where a specific example from the prior art within the claimed range anticipates the range).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the capsule size of modified Alston to specifically be a size 3 capsule for inhaling nicotine powder, as taught by Zuber, as a known formulation and capsule size for use with an inhaler article.
Claims 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Alston (US 2004/0206350) in view of Dunne (US 2014/0182587), as applied to claim 1 above, in further view of Buehler (US 2017/0135397).
Regarding claim 14, Alston in view of Dunne disclose the inhaler article of claim 1, as discussed above.
While Alston discloses an opening (145) through which a user can inhale at the downstream end of the body (105) (paragraph 23, lines 9-13; Fig. 1A, note the annotated version above for the downstream end), presently modified Alston fails to disclose a mouthpiece element received at the opening.
However, Buehler teaches an inhaler article (30) to deliver nicotine powder (paragraph 74, lines 1-2; Figs. 1 and 3), wherein the device further includes a detachable mouthpiece element (paragraph 57, lines 11-13).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of modified Alston to further include a detachable mouthpiece element placed at the opening at the downstream end, such a detachable mouthpiece element taught by Buehler, in order to facilitate the removal of the portion placed within the user’s mouth for cleaning.
Regarding claim 15, Alston in view of Dunne and Buehler disclose the inhaler article of claim 14, as discussed above.
Presently modified Alston discloses wherein the mouthpiece element (see paragraph 57 lines 11-13 of Buehler) defines a downstream end of the capsule receptacle (Alston: 110) (note Fig. 1A of Alston, where the opening 145 where the mouthpiece is placed as modified, is downstream of chamber 110).
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/PAIGE KATHLEEN BUGG/Primary Examiner, Art Unit 3785
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