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 .
Priority
Acknowledgment is made of applicant’s claim for priority under 35 U.S.C. § 119(a-d) with reference to Application Number: EP20213327.8 filed on 12/11/2020.
Information Disclosure Statement
The Information Disclosure Statement(s) have been reviewed by the examiner and are found to comply with the provisions of 37 CFR 1.97, 1.98, and MPEP § 609.
Drawings
The drawing(s) have been reviewed by the examiner and are found to comply with the provisions of 37 CFR 1.81 to 1.85.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “airflow element” in claims 7 – 9 and 17.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
Claim 12 is objected to because of the following informalities: examiner recommends claiming that the housing is “configured to be” grounded to a user. While claim 1 earlier establishes that the inhaler holder is in the grounded state during its intended use, examiner nonetheless recommends the “configured to” language to completely ensure that the user is not positively claimed. Appropriate correction is required.
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 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.
Claim(s) 1 - 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Campitelli (WO 2020178714) in view of Calvert (US 6092522).
1. Campitelli discloses an inhaler article holder (150) comprising: a housing (151) defining a housing cavity (152) and an outer surface (153) (see Fig. 1, p. 22, last paragraph); a sleeve positioned within the housing cavity (180), wherein the sleeve is arranged to receive an inhaler article (110, see Fig. 3c) and the sleeve is movable within the housing cavity between a first position and a second position (p. 23, para. 1, p. 24, para. 3); and a piercing element (160) arranged to pierce the inhaler article received within the sleeve when the sleeve is in the second position (p. 23, para. 3, p. 24, para. 3).
However, Campitelli does not disclose wherein the sleeve is electrically coupled to the housing to form a static electricity discharge circuit when the housing is electrically grounded. Nonetheless, Calvert discloses an inhaler article holder comprising a housing defining a housing cavity with inner components such as partition walls (see Figs. 1- 3, housing 1, 2, 4, with partition wall 8 holding inhaler article 5), wherein the entire device or substantial entirety of the device is formed from anti-static material, e.g. having a surface resistivity less than 1 x 10^11 ohms (see c. 5: 20 – 63, c. 3: 29 – 33). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the entirety of the device of Campitelli, or alternatively the substantial entirety of the device, e.g. inclusive of sleeve 180 and housing 150, from anti-static material as taught in Calvert for the benefit of minimizing the extent to which released powdered medicament can agglomerate on the surfaces of the air passage through the inhaler. Forming an entirety or substantial entirety of the device from anti-static material may additionally reduce cost-to-manufacture if constructing the device from a reduced material stream.
Upon providing the modification as described, the sleeve of modified Campitelli is electrically coupled to the housing to form a static electricity discharge circuit when the housing is electrically grounded. Examiner notes that the sleeve of Campitelli contacts both the spring/piercing element as well as the housing, see Figs. 2 and 5, for electrical coupling therethrough. The device of Calvert cannot be anti-static without discharge to ground, and the sleeve and housing of the modified Campitelli would form a static electricity discharge circuit when the housing is electrically grounded.
2. The modified Campitelli discloses the inhaler article holder according to claim 1, further comprising a spring member contacting a portion of the sleeve (see Fig. 2), and the spring member electrically coupling the sleeve with the housing (upon modifying the entirety of Campitelli from anti-static material as described in Calvert, the spring would electrically couple the sleeve with the housing; in an alternative interpretation, examiner notes that it would have been obvious to construct the spring from the metal material described in p. 12, last paragraph, which is electrically conductive material; metal is a well-known spring material providing the predictable result of maintaining its rigidity/form).
3. The modified Campitelli discloses the inhaler article holder according to claim 1, wherein the piercing element electrically couples the sleeve with the housing (see p. 12, last paragraph, Figs. 2 and 5 illustrating contact with the sleeve for electrical coupling through the metal piercing material; for an alternative interpretation, see also p. 13, para. 3, the metal fiber polymeric material for the piercing element is similar to the material discussed in c. 5: 36 – 39 of Calvert, and it would have been obvious to modify the piercing element from the same anti-static material for the benefit of reduced agglomeration/cost as described above).
4. Campitelli discloses the inhaler article holder according to claim 2, wherein the piercing element is disposed within the spring member (see Fig. 2).
5. The modified Campitelli discloses the inhaler article holder according to claim 1, but does not disclose wherein the housing is formed of a metal. Nonetheless, Campitelli discloses use of a metal material within the inhaler, see p. 12, last paragraph. Therefore, it would have been obvious to one of ordinary skill in the art to also modify the housing from metal, a well-known material providing the predictable result of maintaining rigidity/form, for the benefit of ensuring protection of the inhaler holder from outside impact using anti-static material.
6. The modified Campitelli discloses the inhaler article holder according to claim 1, wherein the sleeve is formed of a polymer having a surface resistivity less than 1×10.sup.11 ohm/sq (see Calvert, c. 5: 25 – 28).
7. The modified Campitelli discloses the inhaler article holder according to claim 1, wherein the sleeve comprises an airflow element configured to form swirling airflow, and the airflow element is electrically coupled to the housing (in an alternative interpretation of claim 1, Campitelli discloses an inhaler article holder (inhaler holder 150 and 110) comprising: a housing (151) defining a housing cavity (152) and an outer surface (153) (see Fig. 1, p. 22, last paragraph); a sleeve positioned within the housing cavity (112), wherein the sleeve is arranged to receive an inhaler article (130) and the sleeve is movable within the housing cavity between a first position and a second position (p. 23, para. 1, p. 24, para. 3); and a piercing element (160) arranged to pierce the inhaler article received within the sleeve when the sleeve is in the second position (p. 23, para. 3, p. 24, para. 3), wherein the sleeve comprises an airflow element configured to form swirling airflow (122, see p. 23; last paragraph); as discussed in claim 1 above, it would have been obvious to one of ordinary skill in the art to modify the entirety or substantial entirety of the device of Campitelli with the anti-static material of Calvert, including the sleeve 112 and airflow element 122, for the benefit of reduced agglomeration/cost as well as consistent dosage; the airflow element 122 contacts the sleeve and housing, see Fig. 2, p. 26, para. 4, and p. 24, para. 3, and therefore would be electrically coupled to the housing upon providing the modification.)
8. The modified Campitelli discloses the inhaler article holder according to claim 7, wherein the airflow element is formed of a polymer having a surface resistivity less than 1×10.sup.11 ohm/sq (see Calvert, c. 5: 25 – 28).
9. The modified Campitelli discloses the inhaler article holder according to claim 8, wherein the sleeve extends from an open end to a closed end and defines a cylindrical lumen for receiving an inhaler article (under the alternative interpretation, sleeve 112 defines a lumen as illustrated in Fig. 2), the open end of the sleeve is aligned with an opening in the housing for receiving an inhaler article (see Fig. 2, receiving capsule 130), the closed end of the sleeve comprises a sleeve bottom element substantially closing the sleeve at the closed end (see attachment 1 below, “BE”, portion of the end cap that caps that outside of sleeve 112), and the airflow element is coupled to the sleeve bottom element (attachment 1 below, “AE”), and the airflow element extends away from the sleeve bottom element and into the cylindrical lumen of the sleeve (see Fig. 2, attachment 1), and the airflow element is electrically coupled to the housing through the sleeve bottom element and spring member or piercing element (as described in claims 1, 2,3, and 7 above, it would have been obvious to one of ordinary skill in the art to modify the entirety or substantial entirety of the device of Campitelli with the anti-static material of Calvert, including the sleeve 112 and airflow element/bottom element 122, for the benefit of reduced agglomeration/cost as well as consistent dosage; the airflow element contacts the bottom element and spring/piercing element, see Fig. 2, p. 24, para. 3, and therefore would be electrically coupled to the housing upon providing the modification).
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10. The modified Campitelli discloses the inhaler article holder according to claim 9, wherein the sleeve bottom element is formed of a polymer having a surface resistivity less than 1×10.sup.11 ohm/sq (see Calvert, c. 5: 25 – 28).
11. The modified Campitelli discloses the inhaler article holder according to claim 2, further comprising an inner housing formed of a polymer having a surface resistivity less than 1×10.sup.11 ohm/sq, and the inner housing electrically couples the spring member to the housing (in an alternative interpretation of claim 1, Campitelli discloses an inhaler article holder (inhaler holder 150 and 110) comprising: a housing (151) defining a housing cavity (152) and an outer surface (153) (see Fig. 1, p. 22, last paragraph); a sleeve positioned within the housing cavity (112), wherein the sleeve is arranged to receive an inhaler article (130) and the sleeve is movable within the housing cavity between a first position and a second position (p. 23, para. 1, p. 24, para. 3); and a piercing element (160) arranged to pierce the inhaler article received within the sleeve when the sleeve is in the second position (p. 23, para. 3, p. 24, para. 3), wherein spring member 200 indirectly contacts a portion of the sleeve 112, see Fig. 2, the device further comprising an inner housing (180); as discussed in claims 1 and 2 above, it would have been obvious to one of ordinary skill in the art to modify the entirety or substantial entirety of the device of Campitelli with the anti-static material of Calvert, including the sleeve 112, inner housing 180, and spring 200, for the benefit of reduced agglomeration/cost as well as consistent dosage; the inner housing 180 contacts the spring/piercing element, see Fig. 2, and therefore would electrically couple it to the housing upon providing the modification; Calvert discloses a surface resistivity less than 1×10.sup.11 ohm/sq for the anti-static material in c. 5: 25 – 28).
12. The modified Campitelli discloses the inhaler article holder according to claim 1, wherein the housing is grounded to a user contacting the outer surface of the housing (as described in claim 1 above, the device of Calvert cannot be anti-static without discharge to ground; the sleeve and housing of the modified Campitelli would form a static electricity discharge circuit when the housing is electrically grounded, including grounding via user contact of the housing).
13. The modified Campitelli discloses the inhaler article holder according to claim 11, wherein the inner housing electrically couples the piercing element to the housing (see Fig. 5, the piercing element 160 contacts the inner housing 180, and therefore would electrically couple it to the housing upon modification with Calvert as discussed in claims 3 and 11 above).
14. Campitelli discloses an inhaler system comprising, the inhaler article holder according to claim 1 (150), and an inhaler article (110) containing a capsule (130) disposed within a capsule cavity of the inhaler article (defined by 120 and 122), the capsule containing pharmaceutically active particles comprising nicotine, the pharmaceutically active particles having a mass median aerodynamic diameter of about 5 micrometres or less (p. 17, last paragraph, p. 18, para. 1).
15. Campitelli discloses the inhaler system according to claim 14, wherein the capsule further contains a second population of flavour particles having a mass median aerodynamic diameter of about 50 micrometres or greater (p. 18, para. 2).
16. The modified Campitelli discloses the inhaler article holder according to claim 2, wherein the piercing element electrically couples the sleeve with the housing (see p. 12, last paragraph, Figs. 2 and 5 illustrating contact with the sleeve for electrical coupling through the metal piercing material; for an alternative interpretation, see also p. 13, para. 3, the metal fiber polymeric material for the piercing element is similar to the material discussed in c. 5: 36 – 39 of Calvert, and it would have been obvious to modify the piercing element from the same anti-static material for the benefit of reduced agglomeration/cost as described above).
17. The modified Campitelli discloses the inhaler article holder according to claim 7, wherein the sleeve is formed of a polymer having a surface resistivity less than 1×10.sup.10 ohm/sq (see Calvert, c. 5: 25 – 28).
18. The modified Campitelli discloses the inhaler article holder according to claim 4, wherein the sleeve is formed of a polymer having a surface resistivity less than 1×10.sup.10 ohm/sq (see Calvert, c. 5: 25 – 28).
19. The modified Campitelli discloses the inhaler article holder according to claim 18, further comprising an inner housing formed of a polymer having a surface resistivity less than 1×10.sup.10 ohm/sq, and the inner housing electrically couples the spring member to the housing (see discussion in claim 11 above; examiner notes that the sleeve would equate to 112 of Campitelli under the alternative interpretation found in claim 11, and it would have been obvious to modify sleeve 112 and inner housing 180 with the anti-static material of Calvert found in c. 5: 25 – 28 per the discussion above).
20. Campitelli discloses an inhaler system comprising, the inhaler article holder according to claim 1 (150), and an inhaler article (110) containing a capsule (130) disposed within a capsule cavity of the inhaler article (defined by 120 and 122), the capsule containing 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 (p. 17, last paragraph, p. 18, para. 1), and the capsule further containing a second population of flavour particles having a mass median aerodynamic diameter in a range from about 50 to about 200 micrometres (p. 18, para. 2).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20100108062 – sleeve approaching piercing element
US 20200170298 – sleeve approaching piercing element
US 20150013696 – sleeve approaching piercing element
US 3888253 – sleeve approaching piercing element
US 20190116879 – nicotine powder inhalation
US 20200275710 – nicotine powder inhalation
US 20050005929 – anti-static DPI
US 6978915 – anti-static DPI
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRADLEY H PHILIPS whose telephone number is (571)270-5180. The examiner can normally be reached 8:00 - 5:00 M-F.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brandy Lee can be reached at (571) 270-7410. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRADLEY H PHILIPS/Primary Examiner, Art Unit 3799
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