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 an amendment filed on 2/26/2026. As directed by the amendment, no claims were canceled, claim 1 was amended, and no new claims were added. Thus, claims 1-20 are pending for this application.
Claim Rejections - 35 USC § 103
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 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) 1-7 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Ganem (US 2011/0220106) in view of Burr (US 2003/0094173).
Regarding claim 1, Ganem discloses (Fig. 5) an inhaler article comprising:
a body (mouthpiece 12) extending along a longitudinal axis from a mouthpiece end (top end) to a distal end (bottom end);
a capsule cavity (cavity within mouthpiece 12 container capsule 16) defined within the body; and
a tubular element (body 14) extending from the distal end to the capsule cavity (see Fig. 5), the tubular element defining a central passage having a uniform open diameter extending from the distal end to the capsule cavity (see uniform diameter in Fig. 5), the tubular element comprising at least one tangential air inlet (see tangential openings in Fig. 5, positioned tangential to central passage as shown in Fig. 5) for allowing air to enter into the central passage (see Fig. 5),wherein the uniform open diameter of the central passage is less than an inner diameter of the capsule cavity (see smaller diameter of passage compared to capsule cavity in Fig. 5).
Ganem does not disclose the at least one tangential air inlet extending through the tubular element in a direction that is tangential to the central passage.
However, Burr teaches (Fig. 1-3) a tubular element comprising at least one tangential air inlet (inlets 130, described as being “tangentially oriented” as described in paragraph [0026] and as shown and described in U.S. Pat. No. 4,995,385 and U.S. Pat. No. 4,069,819, both of which are incorporated by reference, paragraph [0026]), the at least one tangential air inlet extending through the tubular element in a direction that is tangential to the central passage (see Fig. 3 Burr as well as Fig. 6 of U.S. Pat. No. 4,069,819 to Valentini).
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 one or more tangential air inlets of Ganem to extend through the tubular element in a direction that is tangential to the central passage, as taught by Burr, for the purpose of generating swirling airflow that causes rotation of the capsule, and thus improves mixing and aerosolization effect (paragraph [0026] Burr), and thus improve therapeutic outcome.
Regarding claim 2, modified Ganem discloses wherein the at least one tangential air inlet is proximate to the distal end of the inhaler article body (see Fig. 5 Ganem).
Regarding claim 3, modified Ganem discloses wherein the central passage comprises a first end defining an upstream boundary of the capsule cavity (see opening adjacent to capsule cavity Fig. 5 Ganem) and a second opposing end defining the distal end of the inhaler article body (see opening on opposite end of element 14 in Fig. 5 Ganem).
Regarding claim 4, modified Ganem discloses wherein the second opposing end defines an open distal end of the of the inhaler article body (see Fig. 5 Ganem).
Regarding claim 5, modified Ganem discloses wherein central passage extends along the longitudinal axis of the body of the inhaler article and defines an opening at the distal end of the body (see Fig. 5 Ganem) of the inhaler article that is coaxial with the longitudinal axis of the body of the inhaler article (see Fig. 5 for coaxial relationship).
Regarding claim 6, modified Ganem discloses wherein a lateral distance between the at least one tangential air inlet and the capsule cavity is greater than a lateral distance from the distal end of the inhaler article body to the at least one tangential air inlet (Fig. 5 shows the air inlets are adjacent to the opening of tubular member opposite the capsule cavity and thus closer to the distal end of the inhaler article body (since the opening end of tubular member is proximate the distal end of the inhaler article body as shown in Fig. 5) compared to the capsule cavity)).
Regarding claim 7, modified Ganem discloses the tubular element comprises at least two air inlets (see two inlets in Fig. 5), the at least two air inlets extend in a direction that is tangential to the central passage (extend in left-right direction that is tangential to central passage, see Fig. 5).
Regarding claim 11, modified Ganem discloses a capsule (capsule 26) retained within the capsule cavity (see Fig. 5).
Claim(s) 1, 7 and 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Zuber (WO 2017109678, hereinafter Zuber ‘678) in view of Buehler (US 2017/0135397).
Regarding claim 1, Zuber ‘678 discloses (Fig. 1-3) an inhaler article comprising:
a body (body 110) extending along a longitudinal axis from a mouthpiece end (mouthpiece end 112) to a distal end (distal end 114);
a capsule cavity (capsule cavity 116) defined within the body;
a tubular element (end cap 120) extending from the distal end to the capsule cavity (see Fig. 2), the tubular element defining a central passage (piercing channel shown in Fig. 1, see page 13 lines 22-26) having an open diameter
the tubular element comprising at least one tangential air inlet (inlet of channels 113 shown in Fig. 1) for allowing air to enter into the central passage (air is a fluid, and is thus able to enter the central passage from the inlets, through channels 113, and through the end of piercing channel having the uniform diameter, therefore the inlets allow for the air to enter the central passage), the at least one tangential air inlet extending through the tubular element in a direction that is tangential to the central passage (air inlet is a groove through the tubular element that extends along side surface of the end cap 120 and thus extends in a direction tangential to the central passage due to being tangent to the central passage at the midpoint of the air inlet, see relationship between air inlet 133 and axis of central passage LA in Figs. 1-2).
Zuber ‘678 does not show or describe the entire interior of the central passage, however Fig. 1 appears to suggest that the central passage is non-uniform based on how the opening is illustrated, and thus does not disclose the central passage has a uniform open diameter wherein the uniform open diameter of the central passage is less than an inner diameter of the capsule cavity.
However, Buehler teaches (Fig. 1-3) an inhaling device comprising a tubular member (segment 14, described as being “annular” in paragraph [0070] and a having a length as shown in Fig. 1, and thus tubular) having a central passage (hollow portion 18) has a uniform open diameter (see uniform open diameter in Fig. 1 and 3) wherein the uniform open diameter of the central passage is less than an inner diameter of the capsule cavity (see smaller diameter of tubular member 14 compared to capsule cavity 28 in Fig. 1 and 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 modify the central passage of Zuber ‘678 to having a uniform open diameter wherein the uniform open diameter of the central passage is less than an inner diameter of the capsule cavity, as taught by Buehler, for the purpose of improving ease of manufacture while also permitting a reliable sealing function to prevent the capsule from falling out of the device. Furthermore, it has been held that it is “obvious to try” when choosing from a finite number of identified predictable results (i.e. uniform diameter vs. non-uniform diameter) with a reasonable expectation of success, therefore replacing the most likely non-uniform central passage of Zuber ‘678 with a uniform central passage of Buehler would yield the predictable result of providing an opening for a piercing member to be inserted to pierce the capsule an therefore would be obvious to one of ordinary skill in the art at the time the invention was filed (see rationale for obviousness of “obvious to try” of a well-known structure in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007). See also MPEP 2143(I)(B)).
Regarding claim 7, modified Zuber ‘678 discloses the tubular element comprises at least two air inlets (see two inlets in Fig. 2 Zuber ‘678), the at least two air inlets extend in a direction that is tangential to the central passage (see Fig. 1-2).
Regarding claim 11, modified Zuber ‘678 discloses a capsule (capsule 130 of Zuber ‘678) retained within the capsule cavity (see Fig. 1-2 Zuber ‘678).
Regarding claim 12, modified Zuber ‘678 appears to disclose that the central passage has a diameter in a range from about 50% to about 90% of a diameter of the capsule (diameter of hollow portion 18 of Buehler appears to be at least 50% diameter of capsule 12 as shown in Fig. 1 Buehler). However, in the case it is not disclosed due to drawings not being to scale, one of ordinary skill in the art before the effective filing date of the claimed invention, outside evidence of criticality, would find it obvious to try to a diameter of the central passage to be between 50-90% of the diameter of the capsule for the purpose of ensuring the passage is large for the needle to pass through but narrow enough so that the capsule does not fall out end of the article through the central passage, since discovering the optimum value only involves routine skill in the art. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ganem (US 2011/0220106) in view of Burr (US 2003/0094173), and further in view of Alston (US 2004/0206350).
Regarding claim 8, modified Ganem discloses at least one air inlet extending a direction tangential to the central passage (see Fig. 5 Ganem), but does not disclose wherein the tubular element comprises at least three air inlets, the at least three air inlets extend in a direction that is tangential to the central passage.
However, Alston teaches (Fig. 1A and 2A-2B) a tubular element (housing 105) comprising at least three air inlets (at least three air inlets 115), the at least three air inlets extend in a direction that is tangential to the central passage (see tangential relationship in Fig. 1A and 2A).
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 at least one air inlets of modified Ganem to include at least three, as taught by Alston, for the purpose of improving aerosolization of the medicament (paragraph [0024] Alston).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ganem (US 2011/0220106) in view of Burr (US 2003/0094173), and further in view of Mironov (WO 2017182485).
Regarding claim 9, modified Ganem discloses a tubular element but does not disclose the tubular element is formed of a cellulose acetate material.
However, Mironov teaches (Fig. 1) a tubular element (sealing element 1) positioned at a distal end of a tube for receiving airflow that is formed of a cellulose acetate material (described as a “hollow cellulose acetate tube” in page 25 lines 21-25).
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 material of the tubular element of modified Ganem to be formed of cellulose acetate material, as taught by Mironov, for the purpose of providing a biocompatible and stable material capable of retaining the capsule within the body.
Claim 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ganem (US 2011/0220106) in view of in view of Burr (US 2003/0094173), and further in view of Haas (US 2011/0220234).
Regarding claim 10, modified Ganem discloses a tubular element but does not disclose the tubular element is formed of a polylactic acid material.
However, Haas teaches (Fig. 1) a tubular element (abutment element 12) positioned at a distal end of a tube (tube 4) for receiving airflow that is formed of a polylactic acid (abutment element 12 described as being integrally formed with shaft and tip, paragraph [0053], and because shaft and tip are made of polylactic acid (PLA, paragraph [0009]), the tubular element 12 is also made of PLA).
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 material of the tubular element of modified Ganem to be formed of polylactic acid, as taught by Haas, for the purpose of providing a biocompatible and stable material capable of retaining the capsule within the body.
Claim(s) 13, and 15-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zuber ‘678 (WO 2017109678) in view of Buehler (US 2017/0135397), and further in view of Lee (US 2020/0170298).
Regarding claim 13, modified Zuber ‘678 discloses the inhaler article according to claim 1 (see rejection of claim 1 over Zuber ‘678 in view of Buehler above), and a capsule (capsule 130 of Zuber ‘678) disposed within the capsule cavity (see Fig. 2 Zuber ‘678), and discloses that the inhaler article is to be pierced by a piercing element (page 13 lines 22-27); but does not disclose structure of the piercing element and does not further disclose a holder receiving the inhaler article, the holder comprising: a housing comprising a housing cavity for receiving an inhaler article; and a sleeve configured to retain an inhaler article within the housing cavity, the sleeve comprising a sleeve cavity and being movable within the housing cavity along a longitudinal axis of the housing, wherein the sleeve comprises a first open end and a second opposing end, the first open end is configured to receive an inhaler article and the second opposing end of the sleeve is configured contact the distal end of the inhaler article.
However, Lee teaches (Fig. 5) an inhaling device comprising a holder receiving an inhaler article (“aerosol generating device”, paragraph [0080]-[0081]) which includes a piercing element (130) for piercing the inhaler article, the holder comprising: a housing (housing 110) comprising a housing cavity (inner space 110v) for receiving an inhaler article (see Fig. 5); and a sleeve (container 120) configured to retain an inhaler article within the housing cavity, the sleeve comprising a sleeve cavity (accommodating space 120v) and being movable within the housing cavity along a longitudinal axis of the housing (paragraph [0081]), wherein the sleeve comprises a first open end (end of 120 that receives inhaling article 7) and a second opposing end (bottom end of 120 having piercing element 130 passing through), the first open end is configured to receive an inhaler article (see Fig. 5) and the second opposing end of the sleeve is configured contact the distal end of the inhaler article (contacts the portion of article to be pierced, corresponding the distal end).
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 inhaler article and generic piercing element of modified Zuber ‘678 such that the piercing element is mounted within the holder and the holder comprises a housing comprising a housing cavity for receiving an inhaler article; and a sleeve configured to retain an inhaler article within the housing cavity, the sleeve comprising a sleeve cavity and being movable within the housing cavity along a longitudinal axis of the housing, wherein the sleeve comprises a first open end and a second opposing end, the first open end is configured to receive an inhaler article and the second opposing end of the sleeve is configured contact the distal end of the inhaler article, as taught by Lee, for the purpose of allowing the inhaling article to be fixed when pierced so that piercing can be easily achieved and user does not accidentally incur injury or misuse device.
Regarding claim 15, modified Zuber ‘678 discloses a piercing element (piercing element 130 of Lee) fixed to and extending from a housing inner surface (extends from inner surface of fixing portion 150 of housing 110 of Lee, as shown in Fig. 5 Lee), the piercing element being configured to extend through the second opposing end of the sleeve (see Fig. 5) and into the capsule cavity to pierce the capsule along a longitudinal axis of the housing (though Lee does not disclose a capsule, the primary reference Zuber ‘678 already discloses a capsule within a capsule cavity that is pierced by a generic piercing member. Due to the combination of the Zuber ‘678 and Lee references, this limitation is comprehended in order for the goal of Grant to be achieved when combined with Lee).
Regarding claim 16, modified Zuber ‘678 discloses wherein the capsule contains pharmaceutically active particles comprising nicotine (“nicotine”, Abstract Zuber ‘678), the pharmaceutically active particles having a mass median aerodynamic diameter in a range from about 0.5 micrometres to about 4 micrometres (“0.5 micrometres to about 4 micrometres”, page 3 lines 24-26 Zuber ‘678).
Regarding claim 17, modified Zuber ‘678 discloses wherein the tubular element retains the capsule within the capsule cavity (page 13 lines 12-14 Zuber ‘678).
Regarding claims 18-19, modified Zuber ‘678 appears to disclose that the central passage has a diameter in a range from about 50% to about 90% of a diameter of the capsule (diameter of hollow portion 18 of Buehler appears to be at least 50% diameter of capsule 12 as shown in Fig. 1 Buehler). However, in the case it is not disclosed due to drawings not being to scale, one of ordinary skill in the art before the effective filing date of the claimed invention, outside evidence of criticality, would find it obvious to try to a diameter of the central passage to be between 50-90% of the diameter of the capsule for the purpose of ensuring the passage is large for the needle to pass through but narrow enough so that the capsule does not fall out end of the article through the central passage, since discovering the optimum value only involves routine skill in the art. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 20, modified Zuber ‘678 discloses the tubular element central passage comprises a first end defining an upstream boundary of the capsule cavity (end of tubular element 120 proximate to capsule cavity 116 as shown in Fig. 2 Zuber ‘678 and page 13 lines 5-8 Zuber ‘678) and a second opposing end defining the distal end of the inhaler article body (end of tubular element of 120 positioned at distal end 124 of inhaler article body, see Fig. 2 Zuber ‘678 and page 13 lines 5-8 Zuber ‘678).
Claim 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zuber ‘678 (WO 2017109678), Buehler (US 2017/0135397), and Lee (US 2020/0170298), and further in view of Zuber’886 (WO 2018/007886).
Regarding claim 14, modified Zuber ‘678 does not disclose the sleeve second opposing end is configured to direct substantially all inhalation air to flow through the inhaler article at least one tangential air inlet extending in a direction that is tangential to the central passage.
However, Zuber teaches (Fig. 1-4) a holder comprising a sleeve (sleeve portion of distal end portion 30 having mating end 34 and inlet 38) having a first end (end having mating end 34) and second opposing end (end having airway inlet 38) configured to direct substantially all inhalation air to flow through the inhaler article at least one tangential air inlet extending in a direction that is tangential to the central passage (airway inlet 38 aligns with inlet 117 of the inhaler body 110 so that flow can enter the inhaler body, see page 15 lines 24-30 and page 16 lines 15-18).
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 second opposing end of modified Zuber ‘678 to be configured to direct substantially all inhalation air to flow through the inhaler article at least one tangential air inlet extending in a direction that is tangential to the central passage, as taught by Zuber ‘886, for the purpose of allowing the inhaler article to be used while attached to the holder in order to improve stability of the device during use.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-7, 11-14, and 17-20 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claim 27 of US Patent Application 17/770,446 in view of Buehler (US 2017/0135397) and Zuber’886 (WO 2018/007886).
Although the claims are not identical, they are not patentably distinct from one another. The application claims are broader in at least one aspect and also recite additional features not claimed in the patent claims.
For claim 1:
Regarding the broadening aspect of the application claims, the following comparison between the patent claims and the application claims highlights (see underlined features in the patent claims) what elements have been excluded in the presentation of the application claims.
Application ‘446 claim 27
Instant application claim 1
Claim 16. A holder for an inhaler article comprising: a housing comprising a housing cavity for receiving an inhaler article; a sleeve configured to retain an inhaler article within the housing cavity, the sleeve being movable within the housing cavity along a longitudinal axis of the housing, the sleeve comprising: a sleeve cavity; a first open end and a second opposing end, the first open end is configured to receive an inhaler article; the second opposing end of the sleeve comprising: a tubular element extending into the sleeve cavity and having a central passage in fluid communication with the sleeve cavity, the tubular element comprising an outer surface having an outer diameter that faces an inner surface of the sleeve, the tubular element forming an annular recess with the sleeve cavity configured to receive a distal end of an inhaler article, and at least one air inlet; wherein the at least one air inlet extends in a direction that is tangential to the central passage to allow air to enter the sleeve cavity and to induce a swirled airflow pattern on the air entering the sleeve cavity.
Claim 26. An inhaler system comprising: an inhaler article comprising a body extending along an inhaler longitudinal axis from a mouthpiece end to a distal end, and a capsule disposed within the inhaler article body; and the holder for an inhaler article according to claim 16, wherein the sleeve retains the inhaler article received in the sleeve cavity.
Claim 27. An inhaler system according to claim 26, wherein the capsule is retained within a capsule cavity and configured to receive swirling inhalation airflow formed by the second opposing end of the sleeve, the capsule cavity is bounded downstream by a filter element and bounded upstream by an open tubular element.
An inhaler article comprising:
a body extending along a longitudinal axis from a mouthpiece end to a distal end;
a capsule cavity defined within the body;
a tubular element extending from the distal end to the capsule cavity, the tubular element defining a central passage having a uniform open diameter extending from the distal end to the capsule cavity,
the tubular element comprising at least one tangential air inlet for allowing air to enter into the central passage, the at least one tangential air inlet extending in a direction that is tangential to the central passage
wherein the uniform open diameter of the central passage is less than an inner diameter of the capsule cavity.
Thus, it is apparent, for the broadening aspect, that claim 27 of application ‘446 includes features that are not in application claim 1. Following the rationale in In re Goodman, cited above, where applicant has once been granted a patent containing a claim for the specific or narrower invention, applicant may not then obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer. Since application claim 1 is anticipated by claim 27 of application ‘446, with respect to the broadening aspect, and since anticipation is the epitome of obviousness, then application claim 1 is obvious over claim 27 of application ‘446 with respect to the broadening aspect.
With respect to the additional features recited in application claim 1, claim 27 of application ‘446 fails to recite the tubular element defining a central passage extending from distal end to the capsule cavity and having a uniform open diameter extending from the distal end to the capsule cavity, wherein the uniform open diameter of the central passage is less than an inner diameter of the capsule cavity.
However, Buehler teaches (Fig. 1-3) an inhaling device comprising a tubular member (segment 14, described as being “annular” in paragraph [0070] and a having a length as shown in Fig. 1, and thus tubular) having a central passage (hollow portion 18) has a uniform open diameter (see uniform open diameter in Fig. 1 and 3) extending from the distal end to the capsule cavity (see Fig. 1) wherein the uniform open diameter of the central passage is less than an inner diameter of the capsule cavity (see smaller diameter of tubular member 14 compared to capsule cavity 28 in Fig. 1 and 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 modify the central passage of claim 27 of application ‘446 to having a uniform open diameter, as taught by Buehler, for the purpose of improving ease of manufacture while also permitting a reliable sealing function to prevent the capsule from falling out of the device. Furthermore, it has been held that it is “obvious to try” when choosing from a finite number of identified predictable results (i.e. uniform diameter vs. non-uniform diameter) with a reasonable expectation of success, therefore replacing the most likely non-uniform central passage of claim 27 of application ‘446 with a uniform central passage of Buehler would yield the predictable result of providing an opening for a piercing member to be inserted to pierce the capsule an therefore would be obvious to one of ordinary skill in the art at the time the invention was filed (see rationale for obviousness of “obvious to try” of a well-known structure in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007). See also MPEP 2143(I)(B)).
Modified claim 27 of application ‘446 discloses at least one tangential air inlet defined in the sleeve (see claim 16 of application ‘446, from which claim 27 depends), but does not disclose the tubular element comprising at least one tangential air inlet for allowing air to enter into the central passage, the at least one tangential air inlet extending in a direction that is tangential to the central passage.
However, Zuber ‘866 teaches (Fig. 1-4) a holder comprising a sleeve (sleeve portion of distal end portion 30 having mating end 34 and inlet 38) having a first end (end having mating end 34) and second opposing end (end having airway inlet 38) configured to direct substantially all inhalation air to flow through the inhaler article and a tubular element the tubular element (section of receptacle 100 above capsule cavity section having the opening to receive the capsule 120, see Annotated Fig. 6 below) comprising at least one tangential air inlet (air inlet 117) for allowing air to enter into the central passage (page 16 lines 12-14), the at least one tangential air inlet extending in a direction that is tangential to the central passage (inlet positioned on sidewall and thus tangential, see Fig. 6). Airway inlet 38 of sleeve aligns with inlet 117 of the inhaler body 110 so that flow can enter the inhaler body, see page 15 lines 24-30 and page 16 lines 15-18)).
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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 tubular member modified claim 27 of application ‘446 to include at least one tangential air inlet for allowing air to enter into the central passage, the at least one tangential air inlet extending in a direction that is tangential to the central passage, as taught by Zuber ‘886, for the purpose of allowing the inhaler article to be used while attached to the holder in order to improve stability of the device during use.
For dependent claims 11, 13 and 17, the recited limitations are contained in patent claim 27 (see above).
Regarding claim 2, modified claim 27 of application ‘446 discloses wherein the at least one tangential air inlet is proximate to the distal end of the inhaler article body (see Fig. 2 and page 16 lines 12-17 Zuber ‘886).
Regarding claims 3 and 20, modified claim 27 of application ‘446 discloses wherein the central passage comprises a first end defining an upstream boundary of the capsule cavity and a second opposing end defining the distal end of the inhaler article body (see Fig. 1 Buehler)
Regarding claim 4, modified claim 27 of application ‘446 discloses wherein the second opposing end defines an open distal end of the of the inhaler article body (see Fig. 1 Buehler).
Regarding claim 5, modified claim 27 of application ‘446 discloses wherein central passage extends along the longitudinal axis of the body of the inhaler article and defines an opening at the distal end of the body (see Fig. 1 Buehler) of the inhaler article that is coaxial with the longitudinal axis of the body of the inhaler article (see Fig. 1 of Buehler for coaxial relationship).
Regarding claim 6, modified claim 27 of application ‘446 discloses wherein a lateral distance between the at least one tangential air inlet and the capsule cavity is greater than a lateral distance from the distal end of the inhaler article body to the at least one tangential air inlet (Fig. 5 Zuber ‘886 shows the air inlet 117 is adjacent to the opening of tubular member and thus closer to the distal end of the inhaler article body (since the opening end of tubular member is proximate the distal end of the inhaler article body as shown in Fig. 1-2 Zuber ‘886) compared to the capsule cavity)).
Regarding claim 7, modified claim 27 of application ‘446 discloses the tubular element comprises at least two air inlets (two air inlets, page 7 lines 19-27 Zuber ‘886), the at least two air inlets extend in a direction that is tangential to the central passage (see page 7 lines 19-27 Zuber ‘886).
Regarding claims 12 and 18-19, modified claim 27 of application ‘446 appears to disclose that the central passage has a diameter in a range from about 50% to about 90% of a diameter of the capsule (diameter of hollow portion 18 of Buehler appears to be at least 50% diameter of capsule 12 as shown in Fig. 1 Buehler). However, in the case it is not disclosed due to drawings not being to scale, one of ordinary skill in the art before the effective filing date of the claimed invention, outside evidence of criticality, would find it obvious to try to a diameter of the central passage to be between 50-90% of the diameter of the capsule for the purpose of ensuring the passage is large for the needle to pass through but narrow enough so that the capsule does not fall out end of the article through the central passage, since discovering the optimum value only involves routine skill in the art. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 14, modified claim 27 of application ‘446 does not disclose the sleeve second opposing end is configured to direct substantially all inhalation air to flow through the inhaler article at least one tangential air inlet extending in a direction that is tangential to the central passage.
However, Zuber teaches (Fig. 1-4) a holder comprising a sleeve (sleeve portion of distal end portion 30 having mating end 34 and inlet 38) having a first end (end having mating end 34) and second opposing end (end having airway inlet 38) configured to direct substantially all inhalation air to flow through the inhaler article at least one tangential air inlet extending in a direction that is tangential to the central passage (airway inlet 38 aligns with inlet 117 of the inhaler body 110 so that flow can enter the inhaler body, see page 15 lines 24-30 and page 16 lines 15-18).
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 second opposing end of modified claim 27 of application ‘446 to be configured to direct substantially all inhalation air to flow through the inhaler article at least one tangential air inlet extending in a direction that is tangential to the central passage, as further taught by Zuber ‘886, for the purpose of allowing the inhaler article to be used while attached to the holder in order to improve stability of the device during use as well as promoting rotation of the capsule, which improves aerosolization of the particles and thus improves user experience (page 13 lines 1-8 Zuber ‘886).
Claims 8 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claim 27 of US Patent Application 17/770,446 in view of Buehler (US 2017/0135397) and Zuber’886 (WO 2018/007886), and further in view of Alston (US 2004/0206350).
Regarding claims 8, modified claim 27 of application ‘446 discloses at least one air inlet extending a direction tangential to the central passage see Fig. 6 Zuber ‘886), but does not disclose wherein the tubular element comprises at least three air inlets, the at least three air inlets extend in a direction that is tangential to the central passage.
However, Alston teaches (Fig. 1A and 2A-2B) a tubular element (housing 105) comprising at least three air inlets (at least three air inlets 115), the at least three air inlets extend in a direction that is tangential to the central passage (see tangential relationship in Fig. 1A and 2A).
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 at least one air inlets of modified claim 27 of application ‘446 to include at least three, as taught by Alston, for the purpose of improving aerosolization of the medicament (paragraph [0024] Alston).
Claim(s) 9 is rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claim 27 of US Patent Application 17/770,446 in view of Buehler (US 2017/0135397) and Zuber’886 (WO 2018/007886), and further in view of Mironov (WO 2017182485).
Regarding claim 9, modified claim 27 of application ‘446 discloses a tubular element but does not disclose the tubular element is formed of a cellulose acetate material.
However, Mironov teaches (Fig. 1) a tubular element (sealing element 1) positioned at a distal end of a tube for receiving airflow that is formed of a cellulose acetate material (described as a “hollow cellulose acetate tube” in page 25 lines 21-25).
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 material of the tubular element of modified claim 27 of application ‘446 to be formed of cellulose acetate material, as taught by Mironov, for the purpose of providing a biocompatible and stable material capable of retaining the capsule within the body.
Claim 10 is rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claim 27 of US Patent Application 17/770,446 in view of Buehler (US 2017/0135397) and Zuber’886 (WO 2018/007886), and further in view of Haas (US 2011/0220234).
Regarding claim 10, claim 27 of application ‘446 discloses a tubular element but does not disclose the tubular element is formed of a polylactic acid material.
However, Haas teaches (Fig. 1) a tubular element (abutment element 12) positioned at a distal end of a tube (tube 4) for receiving airflow that is formed of a polylactic acid (abutment element 12 described as being integrally formed with shaft and tip, paragraph [0053], and because shaft and tip are made of polylactic acid (PLA, paragraph [0009]), the tubular element 12 is also made of PLA).
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 material of the tubular element of modified claim 27 of application ‘446 to be formed of polylactic acid, as taught by Haas, for the purpose of providing a biocompatible and stable material capable of retaining the capsule within the body.
Claims 15 is rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claim 32 of US Patent Application 17/770,446 in view of Buehler (US 2017/0135397) and Zuber’886 (WO 2018/007886), and further in view of Lee (US 2020/0170298).
Regarding claim 15, modified claim 32 of US Patent Application 17/770,446 discloses the holder further comprises a piercing element configured to pierce the capsule disposed in the inhaler article body (see text of claim 32 of US Patent Application 17/770,446 ) but does not disclose the piercing element fixed to and extending from a housing inner surface, the piercing element being configured to extend through the second opposing end of the sleeve and into the capsule cavity to pierce the capsule along a longitudinal axis of the housing.
However, Lee teaches (Fig. 5) an inhaling device comprising a holder receiving an inhaler article (“aerosol generating device”, paragraph [0080]-[0081]) comprising a piercing element (piercing element 130 of Lee) fixed to and extending from a housing inner surface (extends from inner surface of fixing portion 150 of housing 110 of Lee, as shown in Fig. 5 Lee), the piercing element being configured to extend through the second opposing end of the sleeve (see Fig. 5) and into the capsule cavity to pierce the capsule along a longitudinal axis of the housing (though Lee does not disclose a capsule, the invention of modified claim 32 of US Patent Application 17/770,446 already discloses a capsule within a capsule cavity that is pierced by a generic piercing member, and thus due to the combination of the modified claim 32 of US Patent Application 17/770,446 and Lee references, this limitation is comprehended)
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 invention of modified claim 32 of US Patent Application 17/770,446 such that piercing element fixed to and extending from a housing inner surface, the piercing element being configured to extend through the second opposing end of the sleeve and into the capsule cavity to pierce the capsule along a longitudinal axis of the housing, as taught by Lee, for the purpose of allowing the inhaling article to be fixed when pierced so that piercing can be easily achieved and user does not accidentally incur injury or misuse device.
Claim 16 is rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claim 32 of US Patent Application 17/770,446 in view of Buehler (US 2017/0135397) and Zuber’886 (WO 2018/007886), and further in view of Zuber ‘678 (WO 2017109678).
Regarding claim 16, modified claim 32 of application ‘446 discloses a capsule, but does not disclose the capsule contains pharmaceutically active particles comprising nicotine, the pharmaceutically active particles having a mass median aerodynamic diameter in a range from about 0.5 micrometres to about 4 micrometres.
However, Zuber ‘678 further teaches the capsule (130 of Zuber ‘678) contains pharmaceutically active particles comprising nicotine, the pharmaceutically active particles having a mass median aerodynamic diameter in a range from about 0.5 micrometres to about 4 micrometres (page 2 lines 24-25).
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 capsule of modified claim 32 of application ‘446 to include pharmaceutically active particles comprising nicotine, the pharmaceutically active particles having a mass median aerodynamic diameter in a range from about 0.5 micrometres to about 4 micrometres, as further taught by Zuber ‘678, for the purpose of allowing users dealing with addiction issues due to smoking to safely consume nicotine that is coupled to a medicinal and/or pleasing effect, as well as to a suitable particle size for achieving safe and optimal inhalation of the compounds.
Claims 1-7, 9-15, and 17-20 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claim 17 of US Patent Application 17/770,719 in view of Buehler (US 2017/0135397) and Zuber’886 (WO 2018/007886).
Although the claims are not identical, they are not patentably distinct from one another. The application claims are broader in at least one aspect and also recite additional features not claimed in the patent claims.
For claim 1:
Regarding the broadening aspect of the application claims, the following comparison between the patent claims and the application claims highlights (see underlined features in the patent claims) what elements have been excluded in the presentation of the application claims.
Application ‘719 claim 17
Instant application claim 1
An inhaler article for use in an inhaler system for delivering a dry powder to the lungs of a user of the inhaler system, the inhaler article comprising:
a body extending along a longitudinal axis of the inhaler article from a mouthpiece end to a distal upstream end;
a capsule cavity defined within the body and bounded downstream by a filter element and bounded upstream by a tubular element defining a central passage in fluid communication with the capsule cavity,
the central passage forms an air inlet aperture extending along the longitudinal axis of the inhaler article and from the distal end of the body to the capsule cavity, wherein the tubular element has a central passage inner diameter in a range from about 70% to about 90% of an inner diameter of the capsule cavity;
a capsule disposed within the capsule cavity, the capsule containing the dry powder; wherein the inhaler article is configured to receive a swirling inhalation airflow into the central passage.
An inhaler article comprising:
a body extending along a longitudinal axis from a mouthpiece end to a distal end;
a capsule cavity defined within the body;
a tubular element extending from the distal end to the capsule cavity, the tubular element defining a central passage having a uniform open diameter extending from the distal end to the capsule cavity,
the tubular element comprising at least one tangential air inlet for allowing air to enter into the central passage, the at least one tangential air inlet extending in a direction that is tangential to the central passage
wherein the uniform open diameter of the central passage is less than an inner diameter of the capsule cavity
Thus, it is apparent, for the broadening aspect, that claim 17 of application ‘719 includes features that are not in application claim 1. Following the rationale in In re Goodman, cited above, where applicant has once been granted a patent containing a claim for the specific or narrower invention, applicant may not then obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer. Since application claim 1 is anticipated by claim 17 of application ‘719, with respect to the broadening aspect, and since anticipation is the epitome of obviousness, then application claim 1 is obvious over claim 17 of application ‘719 with respect to the broadening aspect.
With respect to the additional features recited in application claim 1, claim 17 of application ‘719 fails to recite the central passage of the tubular member having a uniform open diameter extending from the distal end to the capsule cavity wherein the uniform open diameter of the central passage is less than an inner diameter of the capsule cavity.
However, Buehler teaches (Fig. 1-3) an inhaling device comprising a tubular member (segment 14, described as being “annular” in paragraph [0070] and a having a length as shown in Fig. 1, and thus tubular) having a central passage (hollow portion 18) has a uniform open diameter (see uniform open diameter in Fig. 1 and 3) extending from the distal end to the capsule cavity (see Fig. 1) wherein the uniform open diameter of the central passage is less than an inner diameter of the capsule cavity (see smaller diameter of tubular member 14 compared to capsule cavity 28 in Fig. 1 and 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 modify the central passage of claim 27 of application ‘719 to having a uniform open diameter, as taught by Buehler, for the purpose of improving ease of manufacture while also permitting a reliable sealing function to prevent the capsule from falling out of the device. Furthermore, it has been held that it is “obvious to try” when choosing from a finite number of identified predictable results (i.e. uniform diameter vs. non-uniform diameter) with a reasonable expectation of success, therefore replacing the most likely non-uniform central passage of claim 17 of application ‘719 with a uniform central passage of Buehler would yield the predictable result of providing an opening for a piercing member to be inserted to pierce the capsule an therefore would be obvious to one of ordinary skill in the art at the time the invention was filed (see rationale for obviousness of “obvious to try” of a well-known structure in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007). See also MPEP 2143(I)(B)).
Modified claim 17 of application ‘719 also fails to recite the tubular element comprising at least one tangential air inlet for allowing air to enter into the central passage, the at least one tangential air inlet extending in a direction that is tangential to the central passage.
However, Zuber ‘866 teaches (Fig. 1-4) a holder comprising a sleeve (sleeve portion of distal end portion 30 having mating end 34 and inlet 38) having a first end (end having mating end 34) and second opposing end (end having airway inlet 38) configured to direct substantially all inhalation air to flow through the inhaler article and a tubular element the tubular element (section of receptacle 100 above capsule cavity section having the opening to receive the capsule 120, see Annotated Fig. 6 below) comprising at least one tangential air inlet (air inlet 117) for allowing air to enter into the central passage (page 16 lines 12-14), the at least one tangential air inlet extending in a direction that is tangential to the central passage (inlet positioned on sidewall and thus tangential, see Fig. 6). Airway inlet 38 of sleeve aligns with inlet 117 of the inhaler body 110 so that flow can enter the inhaler body, see page 15 lines 24-30 and page 16 lines 15-18)).
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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 tubular member of modified claim 17 of application ‘719 to include at least one tangential air inlet for allowing air to enter into the central passage, the at least one tangential air inlet extending in a direction that is tangential to the central passage, as taught by Zuber ‘886, for the purpose of promoting rotation of the capsule, which improves aerosolization of the particles (page 13 lines 1-8 Zuber ‘886).
For dependent claims 3-5, 9-13, 15, and 17-20, the recited limitations are contained in claims 17-21, 27-30, and 34 of application ‘719.
Regarding claim 2, modified claim 17 of application ‘719 discloses wherein the at least one tangential air inlet is proximate to the distal end of the inhaler article body see Fig. 2 and page 16 lines 12-17 Zuber ‘886).
Regarding claim 6, modified claim 17 of application ‘719 discloses wherein a lateral distance between the at least one tangential air inlet and the capsule cavity is greater than a lateral distance from the distal end of the inhaler article body to the at least one tangential air inlet (Fig. 5 Zuber ‘886 shows the air inlet 117 is adjacent to the opening of tubular member and thus closer to the distal end of the inhaler article body (since the opening end of tubular member is proximate the distal end of the inhaler article body as shown in Fig. 1-2 Zuber ‘886) compared to the capsule cavity)).
Regarding claim 7, modified claim 17 of application ‘719 discloses the tubular element comprises at least two air inlets (two air inlets, page 7 lines 19-27 Zuber ‘886), the at least two air inlets extend in a direction that is tangential to the central passage (see page 7 lines 19-27 Zuber ‘886).
Regarding claim 14, modified claim 17 of application ‘719 does not disclose the sleeve second opposing end is configured to direct substantially all inhalation air to flow through the inhaler article at least one tangential air inlet extending in a direction that is tangential to the central passage.
However, Zuber teaches (Fig. 1-4) a holder comprising a sleeve (sleeve portion of distal end portion 30 having mating end 34 and inlet 38) having a first end (end having mating end 34) and second opposing end (end having airway inlet 38) configured to direct substantially all inhalation air to flow through the inhaler article at least one tangential air inlet extending in a direction that is tangential to the central passage (airway inlet 38 aligns with inlet 117 of the inhaler body 110 so that flow can enter the inhaler body, see page 15 lines 24-30 and page 16 lines 15-18).
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 second opposing end of modified claim 17 of application ‘719 to be configured to direct substantially all inhalation air to flow through the inhaler article at least one tangential air inlet extending in a direction that is tangential to the central passage, as further taught by Zuber ‘886, for the purpose of allowing the inhaler article to be used while attached to the holder in order to improve stability of the device during use as well as promoting rotation of the capsule, which improves aerosolization of the particles and thus improves user experience (page 13 lines 1-8 Zuber ‘886).
Claims 8 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claim 17 of US Patent Application 17/770,719 in view of Buehler (US 2017/0135397) and Zuber’886 (WO 2018/007886), and further in view of Alston (US 2004/0206350).
Regarding claims 8, modified claim 17 of application ‘719 discloses at least one air inlet extending a direction tangential to the central passage see Fig. 6 Zuber ‘886), but does not disclose wherein the tubular element comprises at least three air inlets, the at least three air inlets extend in a direction that is tangential to the central passage.
However, Alston teaches (Fig. 1A and 2A-2B) a tubular element (housing 105) comprising at least three air inlets (at least three air inlets 115), the at least three air inlets extend in a direction that is tangential to the central passage (see tangential relationship in Fig. 1A and 2A).
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 at least one air inlets of modified claim 17 of application ‘719 to include at least three, as taught by Alston, for the purpose of improving aerosolization of the medicament (paragraph [0024] Alston).
Claim 16 is rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claim 28 of US Patent Application 17/770,719 in view of Buehler (US 2017/0135397) and Zuber’886 (WO 2018/007886), and further in view of Zuber ‘678 (WO 2017109678).
Regarding claim 16, modified claim 28 of application ‘719 discloses a capsule, but does not disclose the capsule contains pharmaceutically active particles comprising nicotine, the pharmaceutically active particles having a mass median aerodynamic diameter in a range from about 0.5 micrometres to about 4 micrometres.
However, Zuber ‘678 further teaches the capsule (130 of Zuber ‘678) contains pharmaceutically active particles comprising nicotine, the pharmaceutically active particles having a mass median aerodynamic diameter in a range from about 0.5 micrometres to about 4 micrometres (page 2 lines 24-25).
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 capsule of modified claim 28 of application ‘719 to include pharmaceutically active particles comprising nicotine, the pharmaceutically active particles having a mass median aerodynamic diameter in a range from about 0.5 micrometres to about 4 micrometres, as further taught by Zuber ‘678, for the purpose of allowing users dealing with addiction issues due to smoking to safely consume nicotine that is coupled to a medicinal and/or pleasing effect, as well as to a suitable particle size for achieving safe and optimal inhalation of the compounds.
Claims 1-7, 11-14, 16-20 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claim 13 of US Patent Application 18/281,807 in view of Buehler (US 2017/0135397) and Zuber’886 (WO 2018/007886).
Although the claims are not identical, they are not patentably distinct from one another. The application claims are broader in at least one aspect and also recite additional features not claimed in the patent claims.
For claim 1:
Regarding the broadening aspect of the application claims, the following comparison between the patent claims and the application claims highlights (see underlined features in the patent claims) what elements have been excluded in the presentation of the application claims.
Application ‘807 claim 13
Instant application claim 1
Claim 1. An inhaler article holder comprising: a housing defining a housing cavity; a sleeve positioned within the housing cavity, the sleeve is arranged to receive an inhaler article, the inhaler article comprising a body extending along an inhaler longitudinal axis from a mouthpiece end to an inhaler article open distal end and a capsule disposed within the inhaler article body, the sleeve is movable within the housing cavity between a first position and a second position along a longitudinal axis of the housing cavity, the sleeve comprises: a sleeve cavity defined by the sleeve; a first open end configured to receive an inhaler article; a second end opposing the first open end, the second end comprises an end wall at least partially closing the second end; a tubular member fixed to the end wall and extending, a first length from the end wall to a tubular member open end, into the sleeve cavity, the tubular member defining a tubular member cavity having a tubular member longitudinal axis, the tubular member configured to slide into the inhaler article open distal end; and at least two air inlets extend into the tubular member cavity, the at least two air inlets extend orthogonally to the tubular member longitudinal axis, the at least two air inlets enter the tubular member cavity tangentially to induce a swirled airflow pattern on inhalation air entering the sleeve cavity, the at least two air inlets each enter the tubular member cavity adjacent to the end wall and each of the at least two air inlets have a lateral opening dimension in a range from about 0.2 mm to about 0.5 mm; a spring member configured to bias the sleeve away from the second position to the first position; and a piercing element arranged to pass through the end wall and pierce the inhaler article received within the sleeve when the sleeve is in the second position.
Claim 12. An inhaler system comprising: an inhaler article comprising a body extending along an inhaler longitudinal axis from a mouthpiece end to a distal end, and a capsule disposed within the inhaler article body; and the inhaler article holder according to claim 1, wherein the sleeve retains the inhaler article received in the sleeve cavity.
Claim 13. The inhaler system according to claim 12, wherein the capsule is retained within a capsule cavity and configured to receive swirling inhalation airflow formed by the second end of the sleeve, the capsule cavity is bounded downstream by a porous element and bounded upstream by an open tubular element.
An inhaler article comprising:
a body extending along a longitudinal axis from a mouthpiece end to a distal end;
a capsule cavity defined within the body;
a tubular element extending from the distal end to the capsule cavity, the tubular element defining a central passage having a uniform open diameter extending from the distal end to the capsule cavity,
the tubular element comprising at least one tangential air inlet for allowing air to enter into the central passage, the at least one tangential air inlet extending in a direction that is tangential to the central passage
wherein the uniform open diameter of the central passage is less than an inner diameter of the capsule cavity.
Thus, it is apparent, for the broadening aspect, that claim 13 of application ‘807 includes features that are not in application claim 1. Following the rationale in In re Goodman, cited above, where applicant has once been granted a patent containing a claim for the specific or narrower invention, applicant may not then obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer. Since application claim 1 is anticipated by claim 13 of application ‘807, with respect to the broadening aspect, and since anticipation is the epitome of obviousness, then application claim 1 is obvious over claim 13 of application ‘807 with respect to the broadening aspect.
With respect to the additional features recited in application claim 1, claim 13 of application ‘807 fails to recite the tubular element defining a central passage extending from distal end to the capsule cavity and having a uniform open diameter extending from the distal end to the capsule cavity wherein the uniform open diameter of the central passage is less than an inner diameter of the capsule cavity.
However, Buehler teaches (Fig. 1-3) an inhaling device comprising a tubular member (segment 14, described as being “annular” in paragraph [0070] and a having a length as shown in Fig. 1, and thus tubular) having a central passage (hollow portion 18) has a uniform open diameter (see uniform open diameter in Fig. 1 and 3) extending from the distal end to the capsule cavity (see Fig. 1) wherein the uniform open diameter of the central passage is less than an inner diameter of the capsule cavity (see smaller diameter of tubular member 14 compared to capsule cavity 28 in Fig. 1 and 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 modify the central passage of claim 13 of application ‘807 to having a uniform open diameter, as taught by Buehler, for the purpose of improving ease of manufacture while also permitting a reliable sealing function to prevent the capsule from falling out of the device. Furthermore, it has been held that it is “obvious to try” when choosing from a finite number of identified predictable results (i.e. uniform diameter vs. non-uniform diameter) with a reasonable expectation of success, therefore replacing the most likely non-uniform central passage of claim 13 of application ‘807 with a uniform central passage of Buehler would yield the predictable result of providing an opening for a piercing member to be inserted to pierce the capsule an therefore would be obvious to one of ordinary skill in the art at the time the invention was filed (see rationale for obviousness of “obvious to try” of a well-known structure in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007). See also MPEP 2143(I)(B)).
Modified claim 13 of application ‘807 discloses at least one tangential air inlet defined in the sleeve (see claim 1 of application ‘807, from which claim 13 depends), but does not disclose the tubular element comprising at least one tangential air inlet for allowing air to enter into the central passage, the at least one tangential air inlet extending in a direction that is tangential to the central passage.
However, Zuber ‘866 teaches (Fig. 1-4) a holder comprising a sleeve (sleeve portion of distal end portion 30 having mating end 34 and inlet 38) having a first end (end having mating end 34) and second opposing end (end having airway inlet 38) configured to direct substantially all inhalation air to flow through the inhaler article and a tubular element the tubular element (section of receptacle 100 above capsule cavity section having the opening to receive the capsule 120, see Annotated Fig. 6 below) comprising at least one tangential air inlet (air inlet 117) for allowing air to enter into the central passage (page 16 lines 12-14), the at least one tangential air inlet extending in a direction that is tangential to the central passage (inlet positioned on sidewall and thus tangential, see Fig. 6). Airway inlet 38 of sleeve aligns with inlet 117 of the inhaler body 110 so that flow can enter the inhaler body, see page 15 lines 24-30 and page 16 lines 15-18)).
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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 tubular member modified claim 13 of application ‘807 to include at least one tangential air inlet for allowing air to enter into the central passage, the at least one tangential air inlet extending in a direction that is tangential to the central passage, as taught by Zuber ‘886, for the purpose of allowing the inhaler article to be used while attached to the holder in order to improve stability of the device during use.
For dependent claims 11, 13 and 17, the recited limitations are contained in patent claim 27 (see above).
Regarding claim 2, modified claim 13 of application ‘446 discloses wherein the at least one tangential air inlet is proximate to the distal end of the inhaler article body (see Fig. 2 and page 16 lines 12-17 Zuber ‘886).
Regarding claims 3 and 20, modified claim 13 of application ‘807 discloses wherein the central passage comprises a first end defining an upstream boundary of the capsule cavity and a second opposing end defining the distal end of the inhaler article body (see Fig. 1 Buehler)
Regarding claim 4, modified claim 13 of application ‘807 discloses wherein the second opposing end defines an open distal end of the of the inhaler article body (see Fig. 1 Buehler).
Regarding claim 5, modified claim 13 of application ‘807 discloses wherein central passage extends along the longitudinal axis of the body of the inhaler article and defines an opening at the distal end of the body (see Fig. 1 Buehler) of the inhaler article that is coaxial with the longitudinal axis of the body of the inhaler article (see Fig. 1 of Buehler for coaxial relationship).
Regarding claim 6, modified claim 13 of application ‘807 discloses wherein a lateral distance between the at least one tangential air inlet and the capsule cavity is greater than a lateral distance from the distal end of the inhaler article body to the at least one tangential air inlet (Fig. 5 Zuber ‘886 shows the air inlet 117 is adjacent to the opening of tubular member and thus closer to the distal end of the inhaler article body (since the opening end of tubular member is proximate the distal end of the inhaler article body as shown in Fig. 1-2 Zuber ‘886) compared to the capsule cavity)).
Regarding claim 7, modified claim 13 of application ‘807 discloses the tubular element comprises at least two air inlets (two air inlets, page 7 lines 19-27 Zuber ‘886), the at least two air inlets extend in a direction that is tangential to the central passage (see page 7 lines 19-27 Zuber ‘886).
Regarding claims 12 and 18-19, modified claim 13 of application ‘807 appears to disclose that the central passage has a diameter in a range from about 50% to about 90% of a diameter of the capsule (diameter of hollow portion 18 of Buehler appears to be at least 50% diameter of capsule 12 as shown in Fig. 1 Buehler). However, in the case it is not disclosed due to drawings not being to scale, one of ordinary skill in the art before the effective filing date of the claimed invention, outside evidence of criticality, would find it obvious to try to a diameter of the central passage to be between 50-90% of the diameter of the capsule for the purpose of ensuring the passage is large for the needle to pass through but narrow enough so that the capsule does not fall out end of the article through the central passage, since discovering the optimum value only involves routine skill in the art. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 14, modified claim 13 of application ‘807 does not disclose the sleeve second opposing end is configured to direct substantially all inhalation air to flow through the inhaler article at least one tangential air inlet extending in a direction that is tangential to the central passage.
However, Zuber teaches (Fig. 1-4) a holder comprising a sleeve (sleeve portion of distal end portion 30 having mating end 34 and inlet 38) having a first end (end having mating end 34) and second opposing end (end having airway inlet 38) configured to direct substantially all inhalation air to flow through the inhaler article at least one tangential air inlet extending in a direction that is tangential to the central passage (airway inlet 38 aligns with inlet 117 of the inhaler body 110 so that flow can enter the inhaler body, see page 15 lines 24-30 and page 16 lines 15-18).
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 second opposing end of modified claim 13 of application ‘807 to be configured to direct substantially all inhalation air to flow through the inhaler article at least one tangential air inlet extending in a direction that is tangential to the central passage, as further taught by Zuber ‘886, for the purpose of allowing the inhaler article to be used while attached to the holder in order to improve stability of the device during use as well as promoting rotation of the capsule, which improves aerosolization of the particles and thus improves user experience (page 13 lines 1-8 Zuber ‘886).
Regarding claim 16, modified claim 20 of application ‘807 discloses a capsule having pharmaceutically active particles having a mass median aerodynamic diameter in a range from about 0.5 micrometres to about 4 micrometres, but does not disclose the capsule contains pharmaceutically active particles comprising nicotine.
However, Zuber ‘886 further teaches the capsule (130 of Zuber ‘886) contains pharmaceutically active particles comprising nicotine (Abstract Zuber ‘886).
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 capsule of modified claim 20 of application ‘807 to include pharmaceutically active particles comprising nicotine, as taught by Zuber ‘886, for the purpose of allowing users dealing with addiction issues due to smoking to safely consume nicotine that is coupled to a medicinal and/or pleasing effect.
Claim 8 is rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claim 13 of application ‘807 in view of Buehler (US 2017/0135397) and Zuber’886 (WO 2018/007886), and further in view of Alston (US 2004/0206350).
Regarding claims 8, modified claim 13 of application ‘807 discloses at least one air inlet extending a direction tangential to the central passage (see Fig. 6 Zuber ‘886), but does not disclose wherein the tubular element comprises at least three air inlets, the at least three air inlets extend in a direction that is tangential to the central passage.
However, Alston teaches (Fig. 1A and 2A-2B) a tubular element (housing 105) comprising at least three air inlets (at least three air inlets 115), the at least three air inlets extend in a direction that is tangential to the central passage (see tangential relationship in Fig. 1A and 2A).
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 at least one air inlets of modified claim 13 of application ‘807 to include at least three, as taught by Alston, for the purpose of improving aerosolization of the medicament (paragraph [0024] Alston).
Claim(s) 9 is rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claim 13 of application ‘807 in view of Buehler (US 2017/0135397) and Zuber’886 (WO 2018/007886), and further in view of Mironov (WO 2017182485).
Regarding claim 9, modified claim 13 of application ‘807 discloses a tubular element but does not disclose the tubular element is formed of a cellulose acetate material.
However, Mironov teaches (Fig. 1) a tubular element (sealing element 1) positioned at a distal end of a tube for receiving airflow that is formed of a cellulose acetate material (described as a “hollow cellulose acetate tube” in page 25 lines 21-25).
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 material of the tubular element of modified claim 13 of application ‘807 to be formed of cellulose acetate material, as taught by Mironov, for the purpose of providing a biocompatible and stable material capable of retaining the capsule within the body.
Claim 10 is rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claim 13 of application ‘807 in view of Buehler (US 2017/0135397) and Zuber’886 (WO 2018/007886), and further in view of Haas (US 2011/0220234).
Regarding claim 10, claim 13 of application ‘807 discloses a tubular element but does not disclose the tubular element is formed of a polylactic acid material.
However, Haas teaches (Fig. 1) a tubular element (abutment element 12) positioned at a distal end of a tube (tube 4) for receiving airflow that is formed of a polylactic acid (abutment element 12 described as being integrally formed with shaft and tip, paragraph [0053], and because shaft and tip are made of polylactic acid (PLA, paragraph [0009]), the tubular element 12 is also made of PLA).
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 material of the tubular element of modified claim 13 of application ‘807 to be formed of polylactic acid, as taught by Haas, for the purpose of providing a biocompatible and stable material capable of retaining the capsule within the body.
Claims 15 is rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claim 13 of US Patent Application 18/281,807 in view of Buehler (US 2017/0135397) and Zuber’886 (WO 2018/007886), and further in view of Lee (US 2020/0170298).
Regarding claim 15, modified claim 13 application ‘807 discloses the holder further comprises a piercing element configured to pierce the capsule disposed in the inhaler article body (see text of claim 13 of application ‘807 ) but does not disclose the piercing element fixed to and extending from a housing inner surface, the piercing element being configured to extend through the second opposing end of the sleeve and into the capsule cavity to pierce the capsule along a longitudinal axis of the housing.
However, Lee teaches (Fig. 5) an inhaling device comprising a holder receiving an inhaler article (“aerosol generating device”, paragraph [0080]-[0081]) comprising a piercing element (piercing element 130 of Lee) fixed to and extending from a housing inner surface (extends from inner surface of fixing portion 150 of housing 110 of Lee, as shown in Fig. 5 Lee), the piercing element being configured to extend through the second opposing end of the sleeve (see Fig. 5) and into the capsule cavity to pierce the capsule along a longitudinal axis of the housing (though Lee does not disclose a capsule, the invention of modified claim 13 of US Patent Application ‘807 already discloses a capsule within a capsule cavity that is pierced by a generic piercing member, and thus due to the combination of the modified claim 13 of US Patent Application ‘807 and Lee references, this limitation is comprehended)
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 invention of modified claim 13 of US Patent Application ‘807 such that piercing element fixed to and extending from a housing inner surface, the piercing element being configured to extend through the second opposing end of the sleeve and into the capsule cavity to pierce the capsule along a longitudinal axis of the housing, as taught by Lee, for the purpose of allowing the inhaling article to be fixed when pierced so that piercing can be easily achieved and user does not accidentally incur injury or misuse device.
Response to Arguments
Applicant’s arguments filed 2/26/2026 have been fully considered.
Applicant’s arguments with respect to claim(s) 1 being rejected under 35 USC 102 as being anticipated by Ganem have been considered but are moot because the new ground of rejection relies on a new reference not applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Regarding rejection of claim 1 under 35 USC 103 as being obvious over Zuber in view of Buehler, applicant argued (page 9 paragraphs 1-2 and page 10 paragraphs 1-2 Remarks) that Zuber fails to teach the newly added limitation “the at least one tangential air inlet extending through the tubular element in a direction that is tangential to the central passage” because the air inlet (113) of Zuber intersects rather than extending in a direction tangential to the piercing channel.
Examiner respectfully disagrees, as the air inlet 113 of Zuber is clearly shown and described to be positioned external to the central passage (extends through a groove formed on external surface of tubular element 120), and Fig. 2 shows the direction of the air channel as diagonally/coiling around the tubular element (and non-parallel to the axis), and thus there exists at least tangential point over the course of the inlet channel (i.e. at enter point of inlet that intersects with the central axis LA), and thus the inlet exists in direction tangential to central passage.
Applicant’s arguments regarding allowability of the dependent claims have been considered but are moot due to rejection of all independent claims.
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.
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/MATTHEW R MOON/Examiner, Art Unit 3785
/TIMOTHY A STANIS/Supervisory Patent Examiner, Art Unit 3785