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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 February 11, 2026 has been entered.
Priority
Acknowledgement is made to Applicants claim to priority to National stage App. No. PCT/EP2020/082039 filed November 13, 2020 and to Foreign App. No. SE1951314 filed November 14, 2019.
Status of Claims
This Office Action is responsive to the amendment filed on February 11, 2026. As directed by the amendment: claims 1, 3, 11, and 13 have been amended. Thus, claims 1-20 are presently pending in this application.
Claim(s) 1-3, 7-8, 10-13, and 18-20 were previously rejected under 35 U.S.C. 103 as being unpatentable over Lerk et al. (U.S. Pat. No. 5,301,666). Claim(s) 4-6, 9, and 14-17 were previously rejected under 35 U.S.C. 103 as being unpatentable further in view of Hoekman (U.S. Pub. No. 2014/0343494).
Applicant's amendments necessitated the application of new grounds of rejection in light of prior art, shown below.
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.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
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: dosage mechanism in claim 1 and 11.
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 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) 1-3, 7-8, 10-13, and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Esteve et al. (U.S. Pub. No. 2016/0158470; hereinafter: “Esteve’470”) in view of Esteve et al. (U.S. Pub. No. 2011/0120463; hereinafter: “Esteve’463”).
Regarding Claims 1 and 11, Esteve’470 discloses a dry powder inhaler, comprising: a first housing member (1, 4; Fig. 1, 2, 5-8) and a second housing member (2A, 2B; Fig. 1, 2, 5-8) being moveable in relation to one another to prepare administering of at least one medicament dose from at least one medicament reservoir (15; Fig. 5-9; ¶¶ 0039, 0043), at least one air inlet (18; Fig.7-9), a first air outlet (A, Fig. A annotated below) and a second air outlet (B, Fig. A annotated below), the at least one air inlet and the first air outlet connected by a first air channel (C, Fig. A annotated below) via a dosage mechanism (8, 9, 10, 11; Fig. 5, 6, 8) configured to, upon relative movement of said first housing member and said second housing member, arrange at least one dose of at least one medicament from the at least one medicament reservoir into said first air channel (¶¶ 0039-0041), wherein the at least one air inlet and the second air outlet are connected by a second air channel (D, Fig. A annotated below), an inhalation chimney (12; Fig. 5-7, 9) internally defining a proximal portion (E, Fig. A annotated below) of the first air channel and comprising the first air outlet at a first end (at A, Fig. A annotated below) thereof, wherein said inhalation chimney is a separate part (Fig. 5-7; ¶¶ 0042, 0046) and is adjustably connected to the first housing member such that axial movement of said inhalation chimney is allowed at least in relation to the first housing member while said inhalation chimney and the first housing member are secured to one another to absorb dimensional variations in components of the inhaler during manufacturing [Fig. 5-7; ¶¶ 0042, 0046; Examiner notes: Esteve discloses the inhalation chimney as a separate part that is held in slide into place and held there by flange (13; Fig. 6). This allows for any axial movement to absorb dimensional variations in the components of the inhaler during manufacturing.], and wherein the second air outlet is at least partially defined by the first housing member (Fig. 9; 0046).
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Figure A, Adapted from Figure 9 of Esteve’470.
Esteve’470 does not specifically disclose the dry powder inhaler wherein the first housing member and the second housing member being rotatable in relation to one another to prepare administering of at least one medicament dose from the at least one medicament reservoir; and wherein the dosage mechanism is configured to, upon relative rotation of said first housing member and said second housing member, arrange at least one dose of at least one medicament from the at least one medicament reservoir into said first air channel.
Esteve’463 teaches a dry powder inhaler comprising a first housing member (14; Fig. 1-5, 7-8) and a second housing member (16; Fig. 1-5, 7-8) being rotatable in relation to one another to prepare administering of at least one medicament dose (“capsule”; ¶ 0037) from the at least one medicament reservoir (26; Fig. 4-5, 7-10; ¶¶ 0010-0017; 0019; 0036-0039; 0043-0045; Examiner notes: Esteve’463 discloses the second housing member pivoting in relation to the first housing member to prepare administration of the at least one medicament dose from the at least one medicament reservoir. As such the first housing member and the second housing member are rotatable in relation to one another.); and a dosage mechanism (40, 42, 44; Fig. 7-10) is configured to, upon relative rotation of said first housing member and said second housing member, arrange at least one dose of at least one medicament from the at least one medicament reservoir into a first air channel (46; Fig. 7-10; ¶¶ 0039-0044) for the purpose of better accessibility to the at least one medicament reservoir for the insertion, or respectively removal, of the at least one medicament dose (“capsules”) (¶¶ 0019, 0037, 0045).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the dry powder inhaler of Esteve’470 to include the first housing member and the second housing member being rotatable in relation to one another to prepare administering of at least one medicament dose from the at least one medicament reservoir; and wherein the dosage mechanism is configured to, upon relative rotation of said first housing member and said second housing member, arrange at least one dose of at least one medicament from the at least one medicament reservoir into said first air channel as taught by Esteve’463 for the purpose of better accessibility to the at least one medicament reservoir for the insertion, or respectively removal, of the at least one medicament dose (“capsules”) (See Esteve’463: ¶¶ 0019, 0037, 0045).
Regarding Claims 2 and 12, the modified device of Esteve’470 discloses the dry powder inhaler wherein the second air outlet is arranged surrounding the first air outlet (See Esteve’470: Fig. 9; ¶¶ 0046).
Regarding Claims 3 and 13, the modified device of Esteve’470 discloses the dry powder inhaler wherein the first end of the inhalation chimney is supported by and at the first housing member [See Esteve’470: 4; Fig. 5-7; ¶¶ 0042, 0046; Examiner notes: Esteve’470 discloses flange (13; Fig. 6) of the inhalation chimney being supported by and at the first housing member (4; Fig. 5-7).], and wherein a second end (at E, Fig. A annotated above) of the inhalation chimney is connectable to the dosage mechanism (See Esteve’470: Fig. 5, 6, 9; Examiner notes: Esteve’470 discloses the second end of the inhalation chimney being directly or intermediary connectable to the dosage mechanism).
Regarding Claims 7 and 18, the modified device of Esteve’470 discloses the dry powder inhaler wherein the inhalation chimney has an annular cross-sectional shape internally forming the first air outlet in a circular shape (See Esteve’470: Fig. 5-9) and the second air outlet in an annular shape surrounding the first air outlet (See Esteve’470: Fig. 5-9).
Regarding Claims 8 and 19, the modified device of Esteve’470 discloses the dry powder inhaler wherein the first air outlet is arranged offset below a surrounding surface of the first housing member (See Esteve’470: Fig. 5-9).
Regarding Claims 10 and 20, the modified device of Esteve’470 discloses the dry powder inhaler wherein the inhalation chimney comprises protrusions (See Esteve’470: 13; Fig. 5, 6), the protrusions defining axial stops limiting the axial movement of the inhalation chimney such that the first end thereof does not protrude outside the first housing member (See Esteve’470: Fig. 5, 6; ¶¶ 0042, 0046).
Claim(s) 4-6, 9, and 14-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Esteve’470 in view of Esteve’463 as applied to claims 2 and 12, respectively, above, and further in view of Hoekman (U.S. Pub. No. 2014/0343494; hereinafter: “Hoekman”).
Regarding Claims 4 and 14, the modified device of Esteve’470 discloses the dry powder inhaler of claim 2 and 12 wherein a support member (See Esteve’470: 13; Fig. 5, 6) is provided on the first housing member providing radial support of the first end of the inhalation chimney while allowing axial movement thereof (See Esteve’470: Fig. 5, 6; ¶¶ 0042, 0046).
The modified device of Esteve’470 does not specifically disclose the dry powder inhaler further comprising a plurality of support members are provided on the first housing member providing radial support of the first end of the inhalation chimney.
Hoekman discloses an aerosol device comprising a plurality of support members (760; Fig. 8A-8C) are provided on a first housing member (720; Fig. 8A-8E) providing radial support of a first end of an inhalation chimney 9710; Fig. 2A, 2B, 8A-8E; ¶¶ 0037, 0038, 0054-0060; Examiner notes: Hoekman discloses the plurality of support members as can be threads or grooves in the interior surface (722; Fig. 8E-8E) of the first housing member.] for the purpose of establishing a spray pattern having circumferential velocity, thereby enabling further penetration (¶¶ 0037-0038, 0059-0060).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the modified device of Esteve’470 to include the plurality of support members are provided on the first housing member providing radial support of the first end of the inhalation chimney as taught by Hoekman for the purpose of establishing a spray pattern having circumferential velocity, thereby enabling further penetration (See Hoekman: ¶¶ 0037-0038, 0059-0060).
Regarding Claim 5, the modified device of Esteve’470 discloses the dry powder inhaler wherein the plurality of support members are arranged evenly spaced around a circumference of a cylindrical opening in the first housing member (See Hoekman: ¶ 0054; Fig. 8A-8E).
The modified device of Esteve’470 discloses the dry powder inhaler wherein the plurality of support members include between two and five.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to set the circumferentially evenly spaced support members to five since it has been held that mere altering of the number of essential working parts of a device involves only routine skill in the art and one of ordinary skill in the art would have had reasonable expectation of success. See MPEP 2144.04
Regarding Claims 6 and 16, the modified device of Esteve’470 discloses the dry powder inhaler wherein the plurality of support members are structured as protrusions (See Hoekman: 714, 730, 760, 762; Fig. 8A-8E) arranged in an opening in the first housing member (See Hoekman: Fig. 8A-8E), said protrusions supporting the inhalation chimney via a press fit connection (See Hoekman: Fig. 8A-8E; ¶¶ 0054-0060; Examiner notes The claimed phrase “said protrusions supporting the inhalation chimney via a press fit connection” is being treated as a product-by-process limitation and since it has been held that a product-by-process limitation is not construed as being limited to the product formed by the specific process recited, therefore, even though the modified device of Esteve’470 is silent as to the process used to form the invention, it appears that product of the modified device of Esteve’470 would be the same or similar as that claimed, especially since both applicant’s product and the prior art product construct the protrusions in the opening of the first housing member (See Hoekman: Fig. 8A-8E; See MPEP 2113.).
Regarding Claims 9 and 17, the modified device of Esteve’470 discloses the dry powder inhaler the dry powder inhaler wherein the inhalation chimney further comprises axially extending grooves (See Hoekman: 714, 762; Fig. 8C) in which the plurality of support members are configured to be arranged (See Hoekman: ¶¶ 0056, 0057).
Regarding Claim 15, the modified device of Esteve’470 discloses the dry powder inhaler wherein the plurality of support members are arranged evenly spaced around a circumference of a cylindrical opening in the first housing member (See Hoekman: ¶ 0054; Fig. 8A-8E).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELLIOT S RUDDIE whose telephone number is (571)272-7634. The examiner can normally be reached M-F usually 9-7 EST.
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/ELLIOT S RUDDIE/Primary Patent Examiner, Art Unit 3785
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