DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 6/1/2026 has been entered.
Response to Amendment
This office action is in response to the amendment filed 6/1/2026. As directed by the amendment, claim 1 has been amended, and claims 21 and 22 have been added. As such, claims 1 and 4-22 are pending in the instant application, wherein claims 13-15 and 20 remain withdraw in response to restriction.
Response to Arguments
Applicant's arguments filed 6/1/2026 have been fully considered but they are not persuasive.
On page 7 of Remarks, Applicant argues that “the Office’s prior “sub-component” reasoning no longer satisfies the claim [1].”
The Examiner agrees that the second/alternative basis for the rejection is no longer applicable to amended claim 1; however, the first basis for the rejection remains applicable. The rejection in view of Grant is updated below to remove the second/alternative basis.
Applicant argues on page 8 of Remarks that “Grant…does not disclose that end cap body 123 is formed of fibrous material…does not disclose that the material defining air channels 112 is fibrous material.”
The Examiner agrees that Grant is silent regarding the material from which the plug portion containing the grooves is made. However, a) the plug portion must be made from some material, b) 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), and c) 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. Zuber teaches that it was known in the inhaler art before the effective filing date of the claimed invention to make an end plug from a solid/integral/single pierceable material comprised of cellulose acetate [Zuber is now included instead of Papania because Zuber teaches a solid pierceable plug made from the same biodegradable material as claimed], and Waller teaches that specifically (porous/fibrous) cellulose acetate tow was a known pierceable material in the inhaler art before the effective filing date of the claimed invention; therefore, Grant is educated by the combination of Zuber and Waller to form the helically-grooved plug thereof from a solid/integral/single pierceable material that is cellulose acetate tow, i.e. the grooves are defined in/by the fibrous material because the whole plug is made from said material, in order to achieve the predictable results discussed in the updated rejection below.
Applicant argues on page 8 of Remarks that Papania teaches an elastomeric material, not a fibrous material, and thus does not teach “wherein the fibrous material defines the helical grooves.”
This piecewise argument is unconvincing. While Papania has been swapped out for the previously-cited Zuber reference in the updated rejections below (because the previously-cited Zuber reference includes more of the claimed limitations in combination and in an inhaler device more similar to that of Grant), 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). The base reference of Grant teaches a plug with helical grooves defined in a material thereof, and both Papania and Zuber teach the use of solid/integral/single material pierceable plugs (where Waller educates modified Grant to include the pierceable material as a fibrous pierceable material); therefore, Grant is educated to form the helically-grooved plug thereof from a solid/integral/single pierceable fibrous material, i.e. the grooves are defined in/by the fibrous material because the whole plug is made from said material, in order to achieve the predictable results discussed in the updated rejection below.
Applicant argues on page 8 of Remarks that Waller’s cellulose acetate tow “is directed to a different structure: a resealable element or membrane disposed along or within a linear piercing channel…not air channel 113…[and] boundary element 140…[also] does not define air channel 113…Waller does not teach or suggest using cellulose acetate tow, or any other fibrous material, to define air channel 113 or any helical groove.”
This piecewise argument is unconvincing. 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). As discussed above, the base reference of Grant teaches a pierceable plug with helical grooves, Zuber educates Grant to make said plug as a solid/integral/single material pierceable plug comprised of cellulose acetate, and Waller teaches that specifically (porous/fibrous) cellulose acetate tow was a known pierceable material in the inhaler art before the effective filing date of the claimed invention; therefore, Grant is educated by the combination of Zuber and Waller to form the helically-grooved plug thereof from a solid/integral/single pierceable material that is cellulose acetate tow, i.e. the grooves are defined in/by the fibrous material because the whole plug is made from said material, in order to achieve the predictable results discussed in the updated rejection below.
Applicant argues on page 9 of Remarks that the Office “has not identified a reason why a person…would have modified Grant’s end cap body 123 so that Grant’s helical air channels 112 are defined by fibrous material…relied on [selecting a known material]…does not supply a reason to redesign the structure so that the select material defines a particular geometric feature... Waller’s cellulose acetate tow is disclosed for a resealable element or membrane disposed along or within a linear piercing channel…for a sealing/piecing function…the Office has not explained why a person…would have taken that sealing material and used it to form Grant’s outer helical air-channel structure…the suitability of cellulose acetate tow for sealing does not provide a person to from a helical-groove-defining body from that material”
The Examiner disagrees that a reason was not provided: pages 11-12 of the Office Action mailed 3/31/2026 clearly state that forming the entire cap of Grant (i.e. include the helical grooves thereof) from a pierceable material would provide the predictable result of “a cap that is easier to manufacture because of less steps and/or fewer different materials (e.g. no [separate] hole formation…the cap is all one material) and/or to avoid an additional opening…that could otherwise collect dirt and/or debris.” This remains true in the updated rejection in view of Grant below. No “redesign [of] the structure” is being asserted or required by the modification of Grant; indeed, Grant Figs. 3A-B already suggest a cap that is a single (pierceable) material, and the Examiner maintains that selecting a well-known pierceable material in the art such as (fibrous/porous) cellulose acetate tow would have been an obvious material selection for producing the predictable results discussed in the rejections below.
Applicant argues on page 9 of Remarks that the Office’s alternative “omitted piercing channel” theory does not satisfy amended claim 1 because “[e]ven if Grant were modified to omit linear piercing channel 121, the Office has not identified any teaching or reasoned basis for forming Grant’s helical air-channel structure from fibrous material…Grant is silent as to the material of the end cap body 123…Waller likewise does not disclose that end cap or end element 120 or air channel 112 is formed of fibrous material.”
The Examiner disagrees that a reasoned basis has not been provided for the same reasons as discussed above. If Grant is modified to omit a separate linear piercing channel, then providing the entire cap made from a pierceable material would have been obvious to an artisan before the effective filing date of the claimed invention in order to retain the piercing functionality, and selecting a material known to be suitable for pierceable inhaler end caps as taught by Zuber and Waller would thus have been obvious for the reasons discussed in the updated rejections below.
Applicant argues on page 10 of Remarks that the citation of Mironov “is directed to material forming an aerosol-cooling element, not a distal end element as claimed…no reasonable linkage to material useful for forming an aerosol-cooling element and the claimed distal end element…does not disclose helical grooves or helical channels of any kind…does not cure the deficiencies.”
In response to applicant's argument that Mironov does not disclose a distal end element with helical grooves made of polylactic acid, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Modified Grant already teaches a distal end element with helical grooves made of a biodegradable material that is cellulose acetate. The reasonable linkage is that Mironov teaches that cellulose acetate and polylactic acid were known to be interchangeable biodegradable materials suitable for use in inhaler articles. Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention that either material is suitable for use in modified Grant, to achieve the predictable results discussed in the rejections of claims 7 and 19 below.
On pages 10-11 of Remarks, Applicant argues that Hill does not teach or suggest “wherein the fibrous material defines the helical grooves.”
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). Hill was not relied for any teaching regarding grooves, as these are already taught by Grant in view of Zuber (or Papania) and Waller.
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, 8-12, 16-18 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Grant et al. (WO 2018/100461 A1; hereinafter “Grant”) in view of Zuber (WO 2017/109626 A1; hereinafter “Zuber”) 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 that is solid at the bottom in Fig. 3B), and at least two grooves (helical air channels 113) (Figs. 2-3B; page 18, lines 1-2), wherein the solid core portion comprises a central portion of the distal end element (Fig. 3B), wherein the central portion is solid (as discussed above) and extends along the longitudinal center axis to the element inner end (Fig. 3B), 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. 2-3B; 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. 2-3B; page 18, lines 1-2, in view of page 17, lines 16-21; see also page 5, line 10-page 6, line 22), wherein the material of the distal end element defines the helical grooves (Figs. 3A-B).
Grant does not disclose wherein the solid core portion extends along the longitudinal center axis from the element distal end to the element inner end. However, eliminating the piercing channel 121 and thus providing a solid core portion from one end to the other is suggested by Grant on page 7, lines 8-9 (“end cap may include a linear piercing channel”) because the term “may” suggests the possibility of the absence of channel 121, and Zuber teaches that it was known in the inhaler device art before the effective filing date of the claimed invention for a pierceable end element (end cap 3) (Fig. 1) to have a solid core portion (radially center portion) that extends along the longitudinal center axis from the element distal end (to the left in Fig. 1) to the element inner end (to the right in Fig. 1) (the entire cap is depicted as a single, solid plug, see Fig. 1 and page 5, lines 3-12). 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 wherein channel 121 is omitted and providing for piercing by forming the entire channel-121-omitted cap (and thus the helical grooves) from pierceable material as taught by Zuber, 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 Zuber, in order to provide the predictable results of a cap that is easier to manufacture because of less steps and fewer different materials (e.g. no hole formation and the cap is all one material) and/or to avoid an external opening (channel 121) that could otherwise collect dirt and/or debris.
Zuber further educates modified Grant to include wherein the distal end element is formed of a biodegradable material, which is a cellulose material, specifically a cellulose acetate material ([t]he end cap element may be formed of any pierceable material…cellulose acetate, Zuber page 5, lines 3-6), 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 using this material to form the entire channel-121-omitted cap of modified Grant as discussed above would provide the predictable result of employing a known pierceable end cap material to form an environmentally friendly end cap for responsible environmental stewardship.
Modified Grant is silent regarding wherein the distal end element comprises a fibrous, porous material. However, 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), formed of a biodegradable material that is a cellulose acetate 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), to be a fibrous, porous material (tow) (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 cellulose acetate distal end element is formed of a fibrous, porous material, i.e. a cellulose acetate tow material, as taught by Waller, thus arriving at wherein the fibrous material defines the helical grooves because it defines the entire cap, in order to provide the predictable result of employing a known and thus easily and/or cheaply sourced pierceable material to form an environmentally friendly end cap for responsible environmental stewardship.
Regarding claim 8, Grant in view of Zuber 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-B; 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-B 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 Zuber 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 Zuber Fig. 1, which demonstrates that it was known in the inhaler device art before the effective filing date of the claimed invention for a pierceable cap (3) distal end (left end in Zuber Fig. 4B) to be substantially aligned with the distal end of the body (2) (Zuber Fig. 1). 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 Zuber, 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 12, Grant in view of Zuber and Waller teaches an inhaler system comprising:
the inhaler article according to claim 1 (as discussed above regarding claim 1); wherein Grant suggests that a separate piercing element may be provided along with the inhaler article (page 3, lines 22-25), and Zuber further educates modified Grant to include
a holder (container 15) configured to receive the inhaler article (Zuber Fig. 3 or 5), in order to provide the predicable result of a convenient article packaging system (Zuber page 12, line 27-page 13, line 19).
Regarding claim 16, Grant in view of Zuber 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 Zuber 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-B; 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 Zuber and Waller teaches the inhaler article according to claim 8, wherein Zuber (and 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.
Regarding claim 22, Grant in view of Zuber and Waller teaches the inhaler article according to claim 8, wherein Grant further discloses/teaches wherein the at least two helical grooves rotate at least 180 degrees from the element distal end to the element inner end (Figs. 3A-B; 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).
Claim(s) 1, 4-6, 8, 10, 11, 16-18, 21 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Buehler (WO 2018/220475 A1; hereinafter “Buehler”) in view of Erlich et al. (US 3,219,043; hereinafter “Erlich”).
Regarding claim 1, Buehler discloses an inhaler article (inhaler article 100) (Figs. 1-3) comprising:
a body (holder body 101) extending along a longitudinal center axis (LA) from a mouthpiece end (mouthpiece end 104) to a distal end (end 106) (Fig. 1);
a capsule cavity (the consumable-article-receiving chamber around tube 110/defined by the air sealing element 120 and the end 106) defined within the body (Figs. 1 and 3); and
a distal end element (second plug of porous material 226) disposed at the distal end of the inhaler article and extending to the capsule cavity (Fig. 3), the distal end element comprising an element distal end (to the right in Fig. 3), an element inner end (to the left in Fig. 3), a solid core portion (the radially central portion of the plug 226) (Fig. 3; page 19, lines 10-11), wherein the solid core portion comprises a central portion of the distal end element (Fig. 3; page 19, lines 10-11), wherein the central portion is solid and extends along the longitudinal center axis from the element distal end to the element inner end (Fig. 3; page 19, lines 10-11), wherein the distal end element is formed of a biodegradable material (the second plug of porous material…comprise[s] cellulose acetate tow, page 15, lines 7-8), wherein the distal end element comprises a fibrous material (cellulose acetate tow, page 15, lines 7-8).
Buehler is silent regarding the distal end element comprising at least two grooves, wherein the at least two grooves 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, and wherein the at least two helical grooves extend along an outer surface of the distal end element; wherein the fibrous material defines the helical grooves. However, Erlich teaches that it was known in the inhaler filter art before the effective filing date of the claimed invention for a fibrous filter plug (filter rod 10a), which can be made from cellulose acetate per col. 5, lines 27-31, to comprise at least two grooves (any two of the grooves between external fibers seen in Fig. 4), wherein the at least two grooves 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 (Fig. 4), and wherein the at least two helical grooves extend along an outer surface of the distal end element (Fig. 4); wherein the fibrous material defines the helical grooves (Fig. 4; col. 2, lines 22-33). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention to modify Buehler to include the distal end element comprising at least two grooves, wherein the at least two grooves 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, and wherein the at least two helical grooves extend along an outer surface of the distal end element; wherein the fibrous material defines the helical grooves as taught by Erlich, in order to provide the predictable results of increasing the bulk and providing a mechanical bond within the tow body of Buehler, thus providing for a more robust plug (Erlich col. 2, lines 30-33).
Regarding claim 4, Buehler in view of Erlich teaches the inhaler article according to claim 1, wherein Buehler further discloses wherein the distal end element is formed of a porous material (porous material 226, Buehler page 15, lines 7-8).
Regarding claim 5, Buehler in view of Erlich teaches the inhaler article according to claim 1, wherein Buehler further discloses wherein the distal end element is formed of a cellulose material (cellulose acetate tow, Buehler page 15, lines 7-8).
Regarding claim 6, Buehler in view of Erlich teaches the inhaler article according to claim 1, wherein Buehler further discloses wherein the distal end element is formed of a cellulose acetate material (cellulose acetate tow, Buehler page 15, lines 7-8).
Regarding claim 8, Buehler in view of Erlich teaches the inhaler article according to claim 1, wherein optimization of ranges of parameters within prior art ranges or through routine experimentation is not sufficient to patentably distinguish the invention over the prior art, see MPEP § 2144.05, and Erlich further educates modified Buehler to include wherein the grooves rotate at least 90 degrees from the element distal end to the element inner end (Buehler Fig. 3 and page 14, lines 5-7 in view of Erlich Fig. 4 and col. 2, lines 23-24: “the fibers are helically twisted in the range of ¼ to 2 turns per inch”), in order to provide the predictable result of sufficiently tightly twisted rod of material to achieve the results discussed above regarding claim 1.
Regarding claim 10, Buehler in view of Erlich teaches the inhaler article according to claim 1, wherein Buehler further discloses wherein a capsule (capsule 210) is disposed within the capsule cavity of the inhaler article (Fig. 3).
Regarding claim 11, Buehler in view of Erlich teaches the inhaler article according to claim 10, wherein Buehler further discloses wherein the capsule contains pharmaceutically active particles comprising nicotine (capsule contains nicotine particles, page 7, lines 29-30), 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 micrometres or less, page 9, lines 1-2).
Regarding claim 16, Buehler in view of Erlich teaches the inhaler article according to claim 10, wherein Buehler further discloses wherein the capsule contains pharmaceutically active particles comprising nicotine (capsule contains nicotine particles, page 7, lines 29-30), 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 micrometres to about 4 micrometres, page 9, lines 1-2).
Regarding claim 17, Buehler in view of Erlich teaches the inhaler article according to claim 4, wherein optimization of ranges of parameters within prior art ranges or through routine experimentation is not sufficient to patentably distinguish the invention over the prior art, see MPEP § 2144.05, and Erlich further educates modified Buehler to include wherein the grooves rotate at least 90 degrees from the element distal end to the element inner end (Buehler Fig. 3 and page 14, lines 5-7 in view of Erlich Fig. 4 and col. 2, lines 23-24: “the fibers are helically twisted in the range of ¼ to 2 turns per inch”), in order to provide the predictable result of sufficiently tightly twisted rod of material to achieve the results discussed above regarding claim 1.
Regarding claim 18, Buehler in view of Erlich teaches the inhaler article according to claim 8, wherein Buehler further discloses wherein the distal end element is formed of a cellulose acetate material (cellulose acetate tow, Buehler page 15, lines 7-8).
Regarding claim 21, Buehler in view of Erlich teaches the inhaler article according to claim 1, wherein Erlich further educates modified Buehler to include wherein the distal end element is deformed such that a twisted form is maintained (Erlich Fig. 4; col. 2, lines 22-36), in order to provide the predictable results discussed above regarding claim 1.
Regarding claim 22, Buehler in view of Erlich teaches the inhaler article according to claim 8, wherein optimization of ranges of parameters within prior art ranges or through routine experimentation is not sufficient to patentably distinguish the invention over the prior art, see MPEP § 2144.05, and Erlich further educates modified Buehler to include wherein the at least two helical grooves rotate at least 180 degrees from the element distal end to the element inner end (Buehler Fig. 3 and page 14, lines 5-7 in view of Erlich Fig. 4 and col. 2, lines 23-24: “the fibers are helically twisted in the range of ¼ to 2 turns per inch”), in order to provide the predictable result of sufficiently tightly twisted rod of material to achieve the results discussed above regarding claim 1.
Claim(s) 7 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Grant in view of Zuber and Waller OR Buehler in view of Erlich 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 Zuber and Waller OR Buehler in view of Erlich teaches the inhaler article according to claims 1 and 8, but modified Grant OR modified Buehler 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 OR modified Buehler 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/suitable material to form an environmentally friendly end cap for responsible environmental stewardship.
Claim(s) 9 is rejected under 35 U.S.C. 103 as being unpatentable over Buehler in view of Erlich as applied to claim 1 above, and further in view of Reevell (GB 2534208 A; hereinafter “Reevell”).
Regarding claim 9, Buehler in view of Erlich teaches the inhaler article according to claim 1, but modified Buehler is silent regarding wherein the element distal end is substantially aligned with the distal end. However, Reevell teaches that it was known in the inhaler art before the effective filing date of the claimed invention for a distal end plug (either first end plug 12 or second end plug 14) on one side of a capsule (56) and made of cellulose acetate tow (Fig. 12; page 5, lines 7-9) to include wherein the element distal end is substantially aligned with the distal end (Fig. 12). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention for modified Buehler to include wherein the element distal end is substantially aligned with the distal end as taught by Reevell, in order to provide the predictable result of a flush end plug for aesthetic purposes and/or to avoid/reduce contamination of the plug and/or to provide the device as a single use device by rendering the plug less easily removed.
Claim(s) 12 is rejected under 35 U.S.C. 103 as being unpatentable over Buehler in view of Erlich as applied to claim 1 above, and further in view of Hill et al. (US 5,501,236; hereinafter “Hill”).
Regarding claim 12, Buehler in view of Erlich teaches an inhaler system comprising:
the inhaler article according to claim 1 (as discussed above regarding claim 1); but modified Buehler is silent regarding
a holder configured to receive the inhaler article. However, Hill teaches 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 OR tray 56) configured to receive the inhaler article (Figs. 3A-B OR 7), such that it would have been obvious to an artisan before the effective filing date of the claimed invention for modified Buehler to include a holder configured to receive the inhaler article as taught by Hill, in order to provide the predictable result of a pierceable mouthpiece-protecting arrangement for hygiene/sanitary purposes OR a holder similar to a standard cigarette holder for aesthetic and/or vapor-cooling reasons and/or to provide a convenient article packaging system.
Conclusion
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/KATHRYN E DITMER/ Primary Examiner, Art Unit 3785
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