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: EP22188457 filed on 08/03/2022.
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 Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 6 and 7 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. The “second angle” with respect to the second diametrical line, should read as the “third angle”, since a second angle with respect to the first diametrical line is earlier introduced in dependent claim 5.
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.
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, 14 -16, 18, and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Parry-Billings (US 20140158126) in view of Gottenauer (DE 19522415).
1. Parry-Billings discloses a dry powder inhaler [0003], comprising: a casing (1, see Fig. 2) having a mouthpiece (3); an inhalation channel housed in the casing and connected to the mouthpiece (27, see Fig. 7a); a container housed in the casing for storing a powdered medicament (7, [0120], Fig. 6a), the container having an opening (see unlabeled opening for dispensing Fig. 28b, 28c, Fig. 6a, [0122]); a de-agglomerator having a vortex chamber (73, see [0155]) located at an end of the inhalation channel opposite the mouthpiece (see Fig. 7a, [0158]); and a metering device comprising a shuttle (15, see [0115]) having a dosing recess formed in a face of the shuttle (18), wherein the shuttle is movable between a filling position, in which the dosing recess is in alignment with the opening of the container and faces said opening to be filled with a dose of the powdered medicament, and an inhalation position, in which the dosing recess is in alignment with the vortex chamber and the inhalation channel (see [0119], Fig. 6a, Fig. 10), for enabling inhalation of the dose of the powdered medicament contained in the dosing recess through the mouthpiece ([0119]); wherein, in a top view, the opening of the container is elongated along a respective major axis (see Figs. 28b, 28c, marked by “8” in Fig. 28c, the unlabeled opening is elongated) and wherein, when the shuttle is in the filling position, an edge of the opening of the container encloses the dosing recess (see Fig. 6a, Fig. 7a, the edge of the opening of the container encloses opening 18; see also annotated figure below pointing out the edge opening “EO”; examiner notes that the container opening is elongated along a width direction as illustrated in Figs. 28b and 28c, and therefore has an even higher enclosing diameter along the width direction).
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However, Parry-Billings does not disclose that the dosing recess is elongated along a respective main axis. Nonetheless, Goettenauer discloses a dry powder inhaler having a mouthpiece (see Fig. 10, 3); a container housed in the casing for storing a powdered medicament (Fig. 1, 100, page 11, first paragraph after “Detailed Description” heading; see provided translation), the container having an opening (105) and a metering device comprising a shuttle (116, see Fig. 6, p. 12, para. 1) having a dosing recess formed in a face of the shuttle (Fig. 6, 124), wherein the shuttle is movable between a filling position, in which the dosing recess is in alignment with the opening of the container and faces said opening to be filled with a dose of the powdered medicament, and an inhalation position, in which the dosing recess is in alignment with an inhalation channel (see p. 13, paras. 4 – 5), for enabling inhalation of the dose of the powdered medicament contained in the dosing recess through the mouthpiece (p. 8, para. 2); wherein the dosing recess is elongated along a respective main axis (see p. 12, last paragraph, p. 13, para. 2). 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 dosing recess of Parry-Billings with the elongation of Gottenauer for the benefit of a larger recess along the transverse dimension of the metering shuttle, which is otherwise limited in its longitudinal or sliding dimension. The elongated or oval shape is furthermore well known within the art for achieving the predictable result of a dosing recess that meters a specified content of drug.
4. The modified Parry-Billings discloses the inhaler of claim 1, wherein the de-agglomerator has two air inlets opening in the vortex chamber, said two air inlets being placed on opposite sides of the vortex chamber and along tangential or substantially tangential inflow directions to form an air vortex in said vortex chamber (see Parry-Billings, Fig. 27, unlabeled openings at end of dotted line); in the inhalation position, the dosing recess faces the vortex chamber and is fully enclosed in the vortex chamber (see Parry-Billings, Fig. 10, [0139]); the dosing recess has opposite ends located along the main axis (see Goettenauer, Fig. 6); and in the inhalation position, each of the opposite ends of the dosing recess is next to one of the air inlets (the opposite ends of the dosing recess align transversely as illustrated in Goettenauer, Fig. 6, which is the alignment of air inlets as illustrated in Parry-Billings, Fig. 4, Figs. 26, 27).
5. The modified Parry-Billings discloses the inhaler of claim 4, wherein a first diametrical line connecting the two air inlets and the main axis delimits between them a second angle other than 0° (see Parry-Billings, Fig. 27, where the main axis of Goettenauer would correspond to the horizontal dotted line, and a first diametrical line connecting the two air inlets could be drawn along a number of different axes because the both air inlets extend around 90 degrees; for example, the air inlets intersect with the vertical dotted line in Fig. 27).
6. The modified Parry-Billings discloses the inhaler of claim 5, wherein the de-agglomerator comprises two curved walls having concavities facing each other, the two curved walls being staggered from each other and delimiting the vortex chamber and the two tangential air inlets; and a second diametrical line passing through a free extremity of each of the curved walls and the main axis delimits between them a second angle other than 0° (see explanation in claim 5 above, where the free extremities each correspond to the air inlets, and therefore would meet the claim language along the same line of reasoning).
8. The modified Parry-Billings discloses the inhaler of claim 4, wherein each of the opposed ends of the dosing recess is located downstream of the respective air inlet with respect to an air inflow entering through said air inlet (see Parry-Billings, Fig. 27, where the main axis of Goettenauer would correspond to the horizontal dotted line, and is thereby located within the cyclone and downstream of the air inlet).
9. The modified Parry-Billings discloses the inhaler of claim 5, wherein the vortex chamber is configured to form a clockwise air vortex and the main axis is rotated clockwise with respect to the first diametrical line; or the vortex chamber is configured to form a counterclockwise air vortex and the main axis is rotated counterclockwise with respect to the first diametrical line (see Parry-Billings, Fig. 27, where the main axis of Goettenauer would correspond to the horizontal dotted line, and a first diametrical line connecting the two air inlets could be drawn along a number of different axes because the both air inlets extend around 90 degrees; for example, the air inlets intersect with the vertical dotted line in Fig. 27; the main axis is thereby rotated therefrom).
10. The modified Parry-Billings discloses the inhaler of claim 6, wherein in the inhalation position, the dosing recess is contained within a base circle having a diameter given by a segment extending between the free extremities of the two curved walls (see Parry-Billings, Fig. 10, showing one half of the vortex with the dosing recess contained within the endmost extent of its curved walls; as illustrated in Fig. 27, the endmost extend of the curved wall defines the base circle “d”).
11. Parry-Billings discloses the inhaler of claim 1, wherein the edge of the opening of the container is substantially elliptical; or the edge of the opening of the container has two major arched sides and two minor straight sides (see Figs. 28b, 28c).
12. The modified Parry-Billings discloses the inhaler of claim 1, wherein a perimeter of the dosing recess comprises two parallel straight lines connected by two arcs and the two parallel straight lines are parallel to the main axis; or the perimeter of the dosing recess is oval or an ellipse and the main axis is a major axis of the ellipse (see Goettenauer, Fig. 6).
14. The modified Parry-Billings discloses the inhaler of claim 1, wherein the dosing recess has a length (L) measured along the main axis and a width (W) measured perpendicular to the main axis; and a ratio L/W is greater than 1 (see Goettenauer, Fig. 6, p. 13, para. 2; an oval inherently comprises the claimed ratio).
15. Parry-Billings discloses the inhaler of claim 1, further comprising a protective member provided between the shuttle and the vortex chamber, wherein: when the shuttle is in the inhalation position, the protective member is slidingly movable on or above the shuttle between a closed position and an open position; in the closed position, the protective member fully covers the dosing recess preventing communication between said dosing recess and the vortex chamber; and in the open position, the protective member leaves the dosing recess exposed to the vortex chamber ([0021]).
16. Parry-Billings discloses the inhaler of claim 1, comprising the powdered medicament, wherein said powdered medicament is a pharmaceutical composition comprising one or more phosphodiesterase-4 (PDE-4) inhibitors selected from the group consisting of tanimilast, cilomilast, roflumilast, tetomilast, oglemilast, apremilast, piclamilast and a salt thereof (see [0104]).
18. Parry-Billings, as modified by Goettenauer, discloses a dry powder inhaler, comprising: a casing with a mouthpiece; an inhalation channel housed in the casing and connected to the mouthpiece; a container housed in the casing for storing a medicament, the container having an opening; a vortex chamber located at an end of the inhalation channel, opposite the mouthpiece; and a shuttle with a dosing recess, the shuttle being movable between a filling position, where the dosing recess aligns with the opening and faces the opening to be filled with a medicament dose, and an inhalation position, in which the dosing recess is in alignment with the vortex chamber and the inhalation channel, for enabling inhalation, through the mouthpiece, of the medicament dose filling the dosing recess; wherein, in a top view, the opening is elongated along a major axis of the opening and the dosing recess is elongated along a main axis of the dosing recess; and wherein, when the shuttle is in the filling position, an edge of the opening encloses the dosing recess (see claim 1 above).
22. Parry-Billings discloses a method to treat a patient, the method comprising administering to the patient, through the inhaler of claim 1, a powdered medicament in an effective amount for treatment of a respiratory disease ([0103]).
Claim(s) 13, 19, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Parry-Billings (US 20140158126) in view of Gottenauer (DE 19522415) in view of Pinon (US 20050183723).
13. Parry-Billings discloses the inhaler of claim 1, wherein the dosing recess has a capacity for the powdered medicament equal to a dosage for the treatment of respiratory disease, see [0081, 0063, 0064, 0089]. However, Parry-Billings does not specifically enumerate the capacity, and therefore does not disclose that the dosing recess capacity is greater than 10 mg. Pinon discloses that medicament dosages for the inhalation treatment of respiratory disease is greater than 10 mg, see [0011]. 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 larger dosing recess of Parry-Billings in view of Gottenauer with a capacity greater than 10 mg for the benefit of delivering the required amount of inhalation medicament to adequately treat the respiratory disease.
19. The modified Parry-Billings discloses a method of treatment of a patient with a respiratory disease, the method comprising administering to the patient a powdered medicament to provide a delivered dose of the powdered medicament greater than 10 mg, the administering performed through the inhaler according to claim 1 (see rejection in claim 13 above).
20. Parry-Billings discloses the method of treatment of claim 19, wherein the powdered medicament is a pharmaceutical composition comprising one or more phosphodiesterase-4 (PDE-4) inhibitors selected from tanimilast, cilomilast, roflumilast, tetomilast, oglemilast, apremilast, piclamilast and a salt thereof (see [0104]).
Claim(s) 17 and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Parry-Billings (US 20140158126) in view of Gottenauer (DE 19522415) in view of “Tanimilast, A Novel Inhaled Pde4 Inhibitor for the Treatment of Asthma and Chronic Obstructive Pulmonary Disease” (hereinafter “Facchinetti”; NPL provided 12/04/2023).
17. Parry-Billings discloses the inhaler of claim 16, but does not disclose wherein the phosphodiesterase-4 (PDE-4) inhibitor is tanimilast. Nonetheless, Facchinetti discloses wherein the phosphodiesterase-4 (PDE-4) inhibitor is tanimilast powder for inhalation treatment, see p. 2, c. 2, end of para. 2. 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 PDE4 inhibiting powder of Parry-Billings according to the tanimilast powder of Facchinetti for the benefit of a PDE4 inhibitor specifically designed for inhalation and to have a robust pulmonary anti-inflammatory profile coupled with low systemic exposure and low emetic effects.
23. The modified Parry-Billings discloses the method of claim 22, wherein the powdered medicament comprises tanimilast (see Facchinetti as rejected in claim 17 above).
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Parry-Billings (US 20140158126) in view of Gottenauer (DE 19522415) in view of Pinon (20050183723) in view of “Tanimilast, A Novel Inhaled Pde4 Inhibitor for the Treatment of Asthma and Chronic Obstructive Pulmonary Disease” (hereinafter “Facchinetti”; NPL provided 12/04/2023).
21. Parry-Billings discloses the method of treatment of claim 20, but does not disclose wherein the administered phosphodiesterase-4 (PDE-4) inhibitor is tanimilast. Nonetheless, Facchinetti discloses wherein the administered phosphodiesterase-4 (PDE-4) inhibitor is tanimilast powder for inhalation treatment, see p. 2, c. 2, end of para. 2. 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 PDE4 inhibiting powder of Parry-Billings according to the tanimilast powder of Facchinetti for the benefit of a PDE4 inhibitor specifically designed for inhalation and to have a robust pulmonary anti-inflammatory profile coupled with low systemic exposure and low emetic effects.
Allowable Subject Matter
Claims 2 and 3 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: Parry-Billings (US 20140158126) in view of Gottenauer (DE 19522415), the closest prior art of record, fails to disclose or suggest that said main axis of the container opening and the major axis of the dosing recess delimit between them a first angle other than 0°. Furthermore, a person having ordinary skill in the art at the time the invention was filed would not have looked to misalign the major axis and main axis as claimed, because such misalignment may cause incomplete/variable filling of the dosing recess from the container opening. Additionally, the misalignment may cause lack of register with the container opening, possibly spilling the medicament. Applicant has modified their dosing recess to increase dosage size while specifically fitting the vortex chamber, see Fig. 10, and the prior art is otherwise absent a teaching or suggestion to modify Parry-Billings as claimed.
Claim 7 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims. The claim has been allowed along similar lines as claims 2 and 3, as discussed in the paragraph above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
See WO 2021105440, provided 08/02/2023, illustrating the dosing recess will within the diameters of the inhalation channel and vortex chamber, as viewed in Fig. 1.
See US 5435301, c. 3: 30 – 34, oval shapes are well known within the art for achieving the predictable result of a metering dosing recess.
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.
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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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