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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on January 7, 2026 has been entered.
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 – 9 and 11 – 16 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.
Claim 1 recites the limitation “the resilient element” in the first paragraph of the body of the claim. It is generally unclear as to whether Applicant intends the limitation to refer to the “upstream resilient element” previously set forth in the preamble or the “resilient material” previously set forth in the first paragraph of the body of the claim. For the purposes of this Office Action, Examiner will interpret the limitation so as to refer to the “upstream resilient element” previously set forth in the preamble of the claim.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1 – 9 and 11 – 16 are rejected under 35 U.S.C. 103 as being unpatentable over Campitelli (International Publication Number WO 2021/079343 A1, cited in IDS) in view of Esposti (International Publication Number WO 2020/240423 A1).
Examiner notes that all citations to Campitelli will actually refer to U.S. patent Application Publication Number 2022/0379051 A1, which claims priority from Campitelli.
Examiner notes that all citations to Esposti will actually refer to U.S. Patent Application Publication Number 2022/0218018, which claims priority from Esposti.
As to claim 1, Campitelli teaches an inhaler system having an upstream resilient element for insertion into a holder to form an inhaler system for providing a dry powder to lungs of a user (abstract), wherein the upstream resilient element comprises rubber silicon, or latex (figures 1 and 2, element 158 being the ‘upstream resilient element’; paragraph 119 and 156) the inhaler system comprising: a disk of resilient material affixed to an upstream end of the inhaler article to form the inhaler article having the upstream resilient element (figures 1 and 2, element 158 being the ‘disk of resilient material’ and element 150 being the ‘inhaler article’; paragraphs 153, 156, 50 – 54, and 119).
However, Campitelli does not teach either how to form the disk of resilient material or how to affix the disk of resilient material to the inhaler article. Esposti teaches a method for affixing an upstream resilient element onto an inhaler article, the inhaler article being configured for insertion into a holder to form an inhaler system for providing a dry powder to lungs of a user (abstract), the method comprising: moving a ribbon of resilient material from a feeder reel to a cutting stage (figure 1, element B being the ‘ribbon of resilient material,’ element 12a being the ‘feeder reel’ and element 14 being the ‘cutting stage’; paragraphs 72 – 75); presenting the ribbon of resilient material to the cutting stage (figure 1, elements B and 14; paragraphs 72 – 75); cutting a disk of resilient material from the ribbon of resilient material to form a cut disk of resilient material (figure 1, element 22 being the ‘cut disk of resilient material’; paragraph 75); presenting the cut disk of resilient material to a glue stage (paragraphs 108 – 112, wherein the ‘gumming device’ is the ‘glue stage’); dispensing glue (paragraphs 110 – 112); applying the glue to the cut disk of resilient material (figure 1, element 22; paragraphs 110 – 112); and, presenting the cut disk of resilient material having the applied glue to an upstream end of the inhaler article (figure 1, element 21 being the ‘inhaler article’; paragraphs 108 – 112 and 76); affixing the cut disk of resilient material having the applied glue to the upstream end of the inhaler article to form an inhaler article having the resilient element (figure 1, elements 22 and 21; paragraph 76). It would have been obvious to one skilled in the art to affix a resilient element onto an inhaler article, as taught by Campitelli, by the method of Esposti, because one skilled in the art would appreciate that the method of Esposti provides the benefit of manufacturing inhaler system in a reproducible and efficient manner.
Examiner recognizes that Esposti does not expressly teach dispensing and applying the glue in a shape of a ring, so as to dispense and apply a “glue ring.” However, Examiner notes that Esposti expressly teaches applying the glue to the cut disk of resilient material in a manner to allow the cut disk of resilient material to be affixed to the inhaler article (figure 1, elements 22 and 21; paragraphs 108 – 112). Furthermore, Campitelli teaches that the inhaler article is tubular shaped (figure 1, element 153; paragraph 153). Therefore, it would have been obvious to one skilled in the art to dispense and apply glue to the cut disk of resilient material, as taught by Campitelli in view of Esposti, in a ring shape, so as to form a ‘glue ring,’ so as to allow the cut disk of resilient material to be affixed to the tubular shaped inhaler article, as desired by Campitelli in view of Esposti, without over-applying the glue.
As to claim 2, Campitelli further teaches cutting 3 cuts in the disk of resilient material to form 6 flaps in the cut disk of resilient material (figure 2, elements 159 being the ‘cuts’; paragraph 156).
As to claim 3, the discussion of claim 2 is incorporated herein.
As to claim 4, Campitelli expressly teaches cutting “two or more” cuts in the disk of resilient material to form 4 or more flaps in the disk of resilient material (figure 2, elements 159 being the ‘cuts’; paragraphs 55 and 156). This teaching makes obvious a step of cutting at least 4 cuts in the disk of resilient material to form at least 8 flaps in the disk of resilient material.
As to claim 5, Campitelli does not expressly teach the range of the 3 cuts. However, it would have been obvious to one skilled in the art to provide the 3 cuts of Campitelli to extend in a range from 65% to 95% of a diameter of the resilient element, so as to provide the benefit of allowing the resilient element to be open and closed without extending the 3 cuts to the outer periphery of the resilient element, as desired by Campitelli (paragraphs 55 and 156).
As to claim 6, Campitelli teaches cutting a central aperture in the disk of resilient material (figure 2, intersection of elements 159 being the ‘central aperture’; paragraphs 55 and 156). Examiner notes that this can be found because Campitelli teaches cutting a plurality of intersecting slits into the disk of resilient material (figure 2, elements 159 being the ‘plurality of intersecting slits’; paragraphs 55 and 159). It is the position of the Examiner that at the point of intersection, the slits form a ‘central aperture’ in the disk of resilient material (figure 2, intersection of elements 159).
As to claim 7, it is the position of the Examiner that the central aperture of Campitelli is less than 30% of a diameter of the resilient element (figure 2, intersection of elements 159).
As to claim 8, the above discussion of claim 8 is also incorporated herein.
As to claim 9, Campitelli teaches inserting a capsule into the inhaler article (figure 1, element 160 being the ‘capsule’; paragraph 153). However, Campitelli does not teach when to insert the capsule into the inhaler article. Esposti teaches inserting a capsule into the inhaler article prior to the affixing step (figure 1, element 21; paragraphs 124 and 70). It would have been obvious to one skilled in the art to insert a capsule into an inhaler article, as taught by Campitelli, prior to a step of affixing a disk of resilient material to the inhaler article, as taught by Esposti, because one skilled in the art would have recognized that inserting the capsule into the inhaler article either prior to or after affixing the disk of resilient material to the inhaler article would provide the same benefit of providing the inhaler article with the capsule and disk of resilient material, as desired by Campitelli.
As to claim 11, Campitelli teaches that the inhaler article comprises: a tubular body extending along a longitudinal axis from a downstream mouthpiece end to an upstream end (figure 1, elements 151 and 153 being the ‘tubular body,’ element 154 being the ‘downstream mouthpiece end,’ and element 149 being the ‘upstream end’; paragraphs 153 – 154); a capsule cavity within the tubular body between the downstream mouthpiece end and the upstream end (figure 1, interior of elements 155 and 153 being the ‘capsule cavity’; paragraph 153); the capsule cavity containing a capsule (figure 1, element 160 being the ‘capsule’; paragraph 153); wherein an upstream boundary of the capsule cavity is defined by the resilient element (figures 1 and 2, elements 149, 153, and 158; paragraph 156), and wherein the affixed resilient element retains the capsule in the capsule cavity (figures 1 and 2, elements 158 and 160; paragraphs 153 and 156).
As to claim 12, Capitelli teaches that the downstream mouthpiece end comprises a blocker element (figure 1, element 157 being the ‘blocker element’; paragraph 153 and 155).
As to claim 13, Capitelli teaches that the tubular body comprises cardboard (figure 1, element 153; paragraph 59).
As to claim 14, Capitelli teaches that the capsule contains pharmaceutically active dry powder comprising nicotine (figure 1, element 160; paragraph 16).
As to claim 15, Capitelli teaches that the resilient material comprises at least one of a color and a symbol (figure 2, element 159 being the ‘symbols’; paragraphs 119 and 156). Examiner notes that Campitelli teaches the resilient material comprising a color because Campitelli expressly teaches the resilient material comprising one of rubber, silicone, or latex (paragraph 119), each of which inherently includes a color.
As to claim 16, Esposti teaches that the upstream resilient element is in a closed position before insertion into the holder (figures 2 and 3, elements 22 and 21), wherein the upstream resilient element of Campitelli in view of Esposti is configured to open to an open position in response to an opening force applied to the upstream resilient element when the inhaler article is inserted into the holder in use (figure 2, elements 158 and 159), and wherein the upstream resilient element is configured to close to the closed position upon removal of the inhaler article from the holder after use is provided (figure 2, elements 158 and 159).
Response to Arguments
Applicant's arguments filed January 7, 2026 have been fully considered but they are not persuasive.
Applicant argues, on pages 7 – 8, that one skilled in the art would not have found it obvious to form the disk of resilient material of Campitelli by the method of Esposti. This is because, Applicant argues, that Campitelli teaches the disk of resilient material comprises rubber, silicon, or latex, while Esposti teaches forming a disk of resilient material which comprises aluminum. Examiner disagrees. Examiner recognizes that Campitelli teaches the disk of resilient material being rubber, silicon, or latex (paragraph 119). However, Esposti’s teaching of the material of the disk of resilient material is rather open-ended and may include porous materials, non-porous materials, flame retardant materials, and aluminum (paragraphs 100 – 103). Therefore, while Esposti teaches that the disk of resilient material may comprises aluminum, this teaching is only one embodiment of the disk of resilient material (paragraph 102, “the closing element may be made of metallic material: for example, aluminum”). Because the rubber, silicon, and latex of Campitelli may reasonably be considered a non-permeable material, it is the position of the Examiner that the teachings of Esposti would allow the material for the rubber, silicon, and latex material of Campitelli.
Furthermore, and more importantly, it is also the position of the Examiner that one skilled in the art would have found it obvious to form the disks of resilient material of Campitelli, which comprise rubber, silicon, or latex, via the method of Esposti. This is because one skilled in the art would have recognized that the steps taught by Esposti, which includes cutting, gluing, and applying, could be performed onto rubber, silicon, and latex in the same manner that they could be performed onto any material taught by Esposti, including aluminum. Examiner notes that there is nothing in either Esposti or Campitelli which would preclude one skilled in the art from performing the method of Esposti onto the rubber, silicon, or latex material of Campitelli.
Conclusion
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/CHRISTOPHER J. BESLER/Primary Examiner, Art Unit 3726
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