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 2/17/2026. As directed by the amendment, claim 1 has been amended, and claim 3 has been cancelled. As such, claims 1 and 4-20 are pending in the instant application, wherein claims 13-15 and 20 remain withdrawn in response to restriction.
Response to Arguments
Applicant's arguments filed 2/17/2026 (hereinafter “Remarks”) have been fully considered but they are not persuasive.
Regarding claim 1, Applicant argues on page 8 of Remarks that Waller discloses cellulose acetate tow “for a resealable element or membrane disposed along or within a linear piercing chamber, not as the material of the distal end itself…supports, at most, that a septum-like membrane within a piercing channel may be formed of cellulose acetate tow; it does not disclose that the end cap/end piece element itself…comprises or is formed of tow.”
The Examiner disagrees that the prior art does not teach the contested limitations. First, in response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., that the entire distal end element be formed of/consist of fibrous material) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). The claims only require that the distal element “comprises a fibrous material” (emphasis added). Therefore, the second/alternative basis of rejection (maintained below), i.e. where the piercing channel is filled from one end to the other with pierceable material, arrives at the claimed invention when using cellulose acetate tow as the pierceable material as taught by Waller, because said material is comprised by the distal end element since it is a part of/a sub-component of the distal end element. Second, 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). While not currently required by the claims, the Examiner notes that the first basis of the rejection (maintained below), i.e. there is no separate linear piercing channel and the whole distal end element, including the core portion where the piercing channel was, is a single (pierceable) material, is based on the teachings of Grant and Papania; Waller was not relied on to teach a solid core that extends as claimed/the entire end cap being formed of the same material as the piercing channel septum. It is the combination of references that arrives at the claimed invention, because it has been held to be within the general skill of one in the art to select a known material on the basis of its suitability for the intended use, see MPEP 2144.07, and Waller demonstrates a known (pierceable) material suitable for use in a (pierceable) end cap application as taught by Grant and Papania, rendering it obvious to arrive at the claimed invention for the reasons maintained below.
Regarding claim 1, Applicant argues on page 8 of Remarks that the Office Action “improperly conflates two different structures.”
The Examiner respectfully notes that that the two structures are not “improperly conflated.” The rejections (maintained below) are based on two different (obvious) modifications of the prior art because the current breadth of the claims allows for different ways of meeting the instant limitations with regards to a solid core portion: either a) omitting the linear piercing channel of Grant and forming the entire distal end element, including the core portion, as a solid (pierceable) whole as taught by Grant and Papania and made from a biodegradable, fibrous material such as the (pierceable) cellulose acetate tow taught by Waller, or b) filling the entire linear piercing channel of Grant end-to-end with a pierceable material made from a biodegradable, fibrous material such as the (pierceable) cellulose acetate tow taught by Waller. There is no conflict between these alternative interpretations, and both are obvious in light of the structure of Grant and the teachings of Papania and Waller for the reasons discussed in the rejections maintained below.
Regarding claim 1, Applicant argues on pages 8-9 of Remarks that “the applied art still must actually teach or suggest using the identified fibrous material for the claimed structural component” (emphasis Applicant’s) and that Waller “ties cellulose acetate tow to a sealing function…not to the formation of the grooved distal element body that shapes airflow.”
First, the Examiner respectfully notes that there is no requirement in MPEP 2144.07, which deals with the selection of a known material on the basis of its suitability for the intended use, that the prior art must teach the known material being used for the exact same component; indeed, if Waller had disclosed a distal end element as claimed, i.e. with a solid core that extends from the element distal end to the element inner end, Waller would have been applied under 35 USC 102. The prior art need only teach that the known material is suitable for the claimed purpose; in this case, the purpose is to provide a sealing function in an inhaler, and Waller teaches a material that provides a sealing function in an inhaler. [Also, fibrous material, e.g. tow, particularly, cellulose acetate tow, was an extremely common material used in inhalers before the effective filing date of the claimed invention, see the Conclusion Section below as evidence, including cellulose acetate tow as the material for forming an entire distal end element as evidenced by previously-cited Zuber WO 2017/109626 A1, Fig. 1, page 5, lines 5-6.] Second, Waller does teach a fibrous material comprised by a distal end element, either as the fill for a piercing channel or to form a solid (pierceable) distal end element, as discussed above and maintained in the rejections below. Therefore, the rejections in view of Waller are maintained.
Regarding claim 1, Applicant argues on page 9 of Remarks that a fibrous material “is not an arbitrary material selection, but instead provides concrete technical benefits…carries patentable technical significance…rather than being a mere aesthetic or preference-based choice.”
In response to applicant's argument that the selection of a fibrous material provides the advantages listed on page 9 of Remarks, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). The Examiner has provided sufficient reasoning from the references themselves and the general knowledge of an artisan to select a biodegradable, fibrous material for forming the distal end element of modified Grant, e.g. the cellulose acetate tow taught as suitable for use in inhaler/distal end elements by Waller, i.e. environmental stewardship and providing for pierceability (if desired); therefore, the claims stand properly rejected. Indeed, one of the “benefits” asserted by Applicant is the same as taught by the prior art, namely, pierceability, i.e. it is a predictable result taught by the prior art.
Regarding claims 7 and 19, Applicant argues on page 10 of Remarks that the rejection “does not articulate why [PHOSITA] would select materials disclosed for a liquid-retention sealing element and apply them to form the claimed grooved distal end element body, nor does it establish that such materials are suitable for the intended use.”
The Examiner disagrees that the rejection is lacking in these aspects. Modified Grant teaches a grooved, biodegradable distal end element for sealing the end of an inhaler compartment. Mironov discloses a biodegradable distal end element for sealing the end of an inhaler compartment made of the same material taught by modified Grant, i.e. cellulose acetate tow, and Mironov also teaches that cellulose acetate and PLA were known substitutes. Therefore, Mironov educates modified Grant to include the distal end element thereof made from PLA, in order to select a biodegradable material known to be suitable for use in inhalers to predictably provide biodegradability. Applicant has provided no objective evidence that the material taught by Mironov would not function as predicted in modified Grant, and there is no reason an artisan would not look to Mironov for suitable materials for inhaler components, since Mironov discloses an inhaler.
Regarding claims 7 and 19, Applicant argues on pages 10-11 of Remarks that they do not have a burden to “demonstrate the inoperability of the prior art…containing a powder is not a claimed requirement and is therefore irrelevant to the obviousness inquiry.”
The Examiner respectfully notes that it was Applicant who was trying to assert a difference/criticality in what a material is used for as a reason not to look toward Mironov. The Examiner agrees that the containing a powder is irrelevant to the obviousness inquiry, as the material of Mironov, if suitable for retaining a liquid, will also be suitable for retaining a powder, as something that requires less tight sealing.
Regarding claims 7 and 19, Applicant again asserts on page 11 of Remarks that the rejection does not “establish that [PHOSITA] would have been motivated to select the materials disclosed in Mironov…and that such materials are suitable.”
The Examiner refers to the discussion above, where Mironov is concerned with a distal end element and suitable materials for use in an inhaler, and thus relevant to the claimed distal end element within an inhaler.
Applicant makes no further substantive arguments with regards to the prior art on pages 11-12 of Remarks.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 4-6, 8-11 and 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Grant et al. (WO 2018/100461 A1; hereinafter “Grant”) in view of Papania et al. (US 8,656,908 B2; hereinafter “Papania”) and Waller et al. (WO 2019/082056 A1; hereinafter “Waller”).
Regarding claims 1 and 4-6, Grant discloses an inhaler article (inhaler article 100) (Figs. 1-2) comprising:
a body (body 110) extending along a longitudinal center axis (LA) from a mouthpiece end (mouthpiece end 112) to a distal end (distal end 114) (Fig. 1; page 17, lines 7-10);
a capsule cavity (capsule cavity 116) defined within the body (Fig. 2; page 17, line 11); and
a distal end element (end cap 120) disposed at the distal end of the inhaler article and extending to the capsule cavity (Fig. 2), the distal end element comprising an element distal end (end cap distal end 124), an element inner end (end cap inner end 122), a solid core portion (the radially central portion of end cap 120, which is solid at the bottom in Fig. 3B, and/or resealable element 129 is solid, see e.g. Figs. 5-6), and at least two grooves (helical air channels 113) (Figs. 2-4B; page 18, lines 1-2), wherein the solid core portion comprises a central portion of the distal end element (Figs. 3B and 4B-6), wherein the central portion is solid (as discussed above) and extends along the longitudinal center axis from the element distal end or to the element inner end (Figs. 3B and 4B-6), wherein the at least two grooves (113) are helical grooves that rotate about the solid core portion along the longitudinal center axis from the element distal end to the element inner end (Figs. 2-4B; page 18, lines 1-2), and wherein the at least two helical grooves extend along an outer surface (the outer surface of end cap body 123) of the distal end element (Figs. 2-4B; page 18, lines 1-2, in view of page 17, lines 16-21; see also page 5, line 10-page 6, line 22).
Grant does not explicitly depict wherein the solid core portion extends along the longitudinal center axis from the element distal end and to the element inner end. However, Papania demonstrates that it was well known in the inhaler device art before the effective filing date of the claimed invention for a pierceable cap (puncturable septum 92) (Fig. 4B) to have a solid core portion (radially center portion) that extends along the longitudinal center axis from the cap distal end (lower end of 92 in Fig. 4B) and to the cap inner end (upper end of 92 in Fig. 4B) (the entire cap/septum is solid/continuous, see Fig. 4B and col. 10, lines 14-20), and it would have been obvious to an artisan before the effective filing date of the claimed invention that the instant limitation discussed above would be met by either of two simple and obvious modifications of the depicted cap of Grant. First, omitting channel 121 would arrive at wherein the solid core portion extends along the longitudinal center axis from the element distal end and to the element inner end, and this modification is suggested by Grant on page 7, lines 8-9 (“end cap may include a linear piercing channel”) because the term “may” expresses the possibility of the presence of channel 121, but also suggests the possibility of the absence of channel 121, and see also e.g. page 3, lines 22-25 and page 9, lines 21-23, which indicate that a piercing element is not a required element of the device, such that the capsule could be opened before being placed into the device and thus no piercing channel 121 would be necessary OR the entire cap could be made from a pierceable material (see e.g. Papania teaching above), such that a separate channel therefore would not be required. Second/alternatively, having the resealable element extend the full length of channel 121 would arrive at wherein the solid core portion extends along the longitudinal center axis from the element distal end and to the element inner end, because the channel would be filled end-to-end with solid material, i.e. a solid core portion, and this arrangement is suggested by Grant page 7, lines 20-21 (“[t]he linear piercing channel may be formed of a pierce-able material”). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention to modify the cap of Grant to include either wherein channel 121 is omitted (providing for piercing by forming the entire channel-121-omitted cap from pierceable material as taught by Papania) OR wherein the resealable element extends the full length of channel 121 as suggested by Grant, such that the solid core portion extends along the longitudinal center axis from the element distal end and to the element inner end as taught by Papania, in order to provide the predictable results of either a cap that is easier to manufacture because of less steps and/or fewer different materials (e.g. no hole formation or overly-involved material 129 placement and the cap is all one material) and/or to avoid an additional opening (through the cap in general OR above/below material 129) that could otherwise collect dirt and/or debris and/or inhalable material, which would reduce the amount thereof that is available to the user.
Modified Grant is silent regarding wherein the distal end element is formed of a biodegradable material because neither Grant (page 7, lines 25-26) nor Papania (col. 10, lines 19-20) specify that the rubber or latex of the pierceable/septum material is naturally derived versus synthetic, and modified Grant is silent regarding wherein the distal end element comprises a fibrous material, which is a porous or cellulose material, specifically a cellulose acetate material. However, it has been held to be within the general skill of one in the art to select a known material on the basis of its suitability for the intended use, see MPEP 2144.07, and Waller demonstrates that it was well known in the inhaler article art before the effective filing date of the claimed invention for a distal end element (end element 120 comprising a resealable element/a septum) (Figs. 1-2; page 6, lines 8-18) to be formed of a biodegradable material (cellulose acetate, page 6, lines 15-18; see also page 12, lines 8-10, which teaches that biodegradable materials are desirable for inhaler article components), particularly a fibrous, porous material (tow) that is a cellulose material, specifically a cellulose acetate material (page 6, lines 15-18). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention for modified Grant to include wherein the distal end element is formed of a biodegradable material and comprises a fibrous material, particularly one that is a porous or cellulose material, e.g. specifically a cellulose acetate tow material, as taught by Waller, in order to provide the predictable result of employing a known pierceable/septum material to form an environmentally friendly end cap for responsible environmental stewardship.
Regarding claim 8, Grant in view of Papania and Waller teaches the inhaler article according to claim 1, wherein Grant further discloses/teaches wherein the grooves rotate at least 90 degrees from the element distal end to the element inner end (Figs. 3A-4B; air channel may rotate around…an arc length…to about 360 degrees…180 degrees…135 degrees, page 5, line 29-page 6, line 3, and where Figs. 3A-4B suggest at least 90 degrees; air channel may include at least two, or two or more air channels…symmetrically disposed, page 6, lines 10-16).
Regarding claim 9, Grant in view of Papania and Waller teaches the inhaler article according to claim 1, wherein Grant further discloses/teaches wherein the element distal end is substantially aligned with the distal end (Fig. 2; end cap may be inserted into the distal end of the inhaler body…the distal end of the inhaler body may surround…100% of the length of the endcap, page 5, lines 12-16), where Grant Fig. 2 depicts the cap 120 as fully inserted into and flush with the distal end of the body, and see also Papania Fig. 4B, which demonstrates that it was well known in the inhaler device art before the effective filing date of the claimed invention for a (pierceable) cap (puncturable septum 92) distal end (lower end of 92 in Papania Fig. 4B) to be substantially aligned with the distal end of the body (that of vial 22) that it is sealing (Papania Fig. 4B). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention for modified Grant to include wherein the element distal end is substantially aligned with the distal end as further taught by Grant and Papania, in order to provide an end cap that is fully protected by the inhaler body by being fully inserted therein but also does not have space above the cap (e.g. the cap is not inserted so far into the body that its distal end is inward of the body distal end) to avoid a space that could otherwise collect dirt and/or debris.
Regarding claim 10, Grant in view of Papania and Waller teaches the inhaler article according to claim 1, wherein Grant further discloses wherein a capsule (capsule 130) is disposed within the capsule cavity of the inhaler article (Fig. 2).
Regarding claim 11, Grant in view of Papania and Waller teaches the inhaler article according to claim 10, wherein Grant further discloses wherein the capsule contains pharmaceutically active particles comprising nicotine (capsule contains nicotine particles, page 9, lines 24-25), the pharmaceutically active particles having a mass median aerodynamic diameter of about 5 micrometres or less (particles comprising nicotine may have a mass median aerodynamic diameter of about 5 micrometers or less, page 11, lines 5-6).
Regarding claim 16, Grant in view of Papania and Waller teaches the inhaler article according to claim 10, wherein Grant further discloses wherein the capsule contains pharmaceutically active particles comprising nicotine (capsule contains nicotine particles, page 9, lines 24-25), the pharmaceutically active particles having a mass median aerodynamic diameter in a range from about 0.5 micrometres to about 4 micrometres (particles comprising nicotine may have a mass median aerodynamic diameter…in a range from about 0.5 micrometers to about 4 micrometers, page 11, lines 5-6).
Regarding claim 17, Grant in view of Papania and Waller teaches the inhaler article according to claim 4, wherein Grant further discloses/teaches wherein the grooves rotate at least 90 degrees from the element distal end to the element inner end (Figs. 3A-4B; air channel may rotate around…an arc length…to about 360 degrees, page 5, line 29-page 6, line 3; air channel may include at least two, or two or more air channels…symmetrically disposed, page 6, lines 10-16).
Regarding claim 18, Grant in view of Papania and Waller teaches the inhaler article according to claim 8, wherein Waller educates modified Grant to include wherein the distal end element is formed of a cellulose acetate material as discussed above regarding claims 1 and 6, in order to utilize a known material to provide the predictable result of a biodegradable end cap for responsible environmental stewardship.
Claim(s) 7 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Grant in view of Papania and Waller as applied to claims 1 and 8 above, and further in view of Mironov (WO 2017/182485 A1; hereinafter “Mironov”).
Regarding claims 7 and 19, Grant in view of Papania and Waller teaches the inhaler article according to claims 1 and 8, but modified Grant is silent regarding wherein the distal end element is formed of polylactic acid material. However, it has been held to be within the general skill of one in the art to select a known material on the basis of its suitability for the intended use, see MPEP 2144.07, and Mironov demonstrates that it was well known in the inhaler article art before the effective filing date of the claimed invention for a distal end element (first sealing element 1) (Fig. 1) to be formed of a biodegradable material (element 1…cellulose acetate, page 25, lines 23-24), and that cellulose acetate and polylactic acid were known to be interchangeable biodegradable materials suitable for use in inhaler articles (page 19, line 27-page 20, line 2). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention for modified Grant to include wherein the distal end element is formed of polylactic acid material as taught by Mironov, in order to provide the predictable result of employing a known material to form an environmentally friendly end cap for responsible environmental stewardship.
Claim(s) 12 is rejected under 35 U.S.C. 103 as being unpatentable over Grant in view of Papania and Waller as applied to claim 1 above, and further in view of Hill et al. (US 5,501,236; hereinafter “Hill”).
Regarding claim 12, Grant in view of Papania and Waller teaches an inhaler system comprising:
the inhaler article according to claim 1 (as discussed above regarding claim 1); but modified Grant is silent regarding
a holder configured to receive the inhaler article. However, Grant does suggest that a separate piercing element may be provided along with the inhaler article (page 3, lines 22-25), and Hill demonstrates that it was known in the inhaler device art before the effective filing date of the claimed invention for an inhaler article system (Figs. 3A-B) to include an inhaler article (cartridge 10) and a holder (cartridge holder 26) configured to receive the inhaler article (Figs. 3A-B), such that it would have been obvious to an artisan before the effective filing date of the claimed invention for modified Grant to include a holder configured to receive the inhaler article as taught by Hill, in order to provide the predictable result of a suitable, protected piercing arrangement OR a holder similar to a standard cigarette holder for aesthetic and/or vapor-cooling reasons.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Additional references teaching fibrous materials, including cellulose acetate tow, for providing plug/sealing functionality in inhalers: Adams et al. (US 5,692,526; col. 7, lines 52-53); Banerjee et al. (US 5,285,798; col. 5, lines 18-19); Borgognon et al. (US 2006/0254607 A1; para [0045]); Chipman (US 2019/0183172 A1; para [0028]); Fulcher et al. (US 2016/0122047 A1; para [0019]). Additional reference teaching the known substitution of cellulose acetate and PLA for inhaler components: Buehler et al. (US 2016/0338402 A1; para [0050]). Reference regarding twisted inhaler components: Elstner (WO 86/03381).
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, T/Th 8:30a-2:30p, W 11:30a-4:30p, F 1-4p ET.
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/KATHRYN E DITMER/Primary Examiner, Art Unit 3785
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