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: SE2150093-9 filed on 01/28/2021.
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.
Election/Restrictions
Applicant's election with traverse of claims 1 0 – 16 and 20 in the reply filed on 07/06/2026 is acknowledged. The traversal is on the ground(s) that the restriction confuses the unity of invention requirement with the requirements for patentability. This is not found persuasive because the restriction as laid out in the action dated 05/07/2026 does not require patentability over the cited reference. Rather, the restriction follows the determination of “Unity of Invention” a posteriori, as outlined in PCT Rule 13 and discussed further MPEP 1850 (II). That is, the restriction outlines the separate groups of inventions, and how they do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features over the prior art as provided.
Applicant further argues that the finding of Unity of Invention at the international stage should apply in the present application since the decision rests “with the internation searching authority” as stated under MPEP 1850(II). Such conclusion is wholly inconsistent with the USPTO as an independent governing authority, and furthermore ignores MPEP 1850 (I), stating the following:
Therefore, when the Office considers international applications as an International Searching Authority, as an International Preliminary Examining Authority, and during the national stage as a Designated or Elected Office under 35 U.S.C. 371, PCT Rule 13.1 and 13.2 will be followed when considering unity of invention of claims of different categories (emphasis added)
Unity of Invention in the instant national stage application filed under 35 USC 371 has been considered under PCT Rule 13.1 and 13.2, consistent with the rules and policies set therewith, as outlined in the restriction dated 05/07/2026.
Applicant lastly argues that adequate search burden does not exist in the instant restriction requirement. The examiner respectfully disagrees. In the instant case, the inventions have acquired a separate status in the art in view of their different classification, the inventions have acquired a separate status in the art due to their recognized divergent subject matter, and the inventions require a different field of search (e.g., searching different classes /subclasses or electronic resources, or employing different search strategies or search queries). The inventions as grouped are directed to different statutory classes of invention, and a search for the subject matter of one of the Groups would not encompass a search for the subject matter of the other of the Groups. For example, the product as claimed could be formed from a materially different method, for example a seal that is cut rather than separately sealed (Group I), or a packaging that is assembled without folding (Group III).
The requirement is still deemed proper and is therefore made FINAL.
Claims 1 – 9 and 17 – 19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 07/21/2026.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 10 – 11 and 14 – 16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Warden (US 20070221218).
10. Warden discloses a packaging for at least one dry powder medicament [0002] comprising: a first row including a first plurality of medicament cavities (see Fig. 4a, outermost concentric row 27w); a second row including a second plurality of medicament cavities (see Fig. 4a, innermost concentric row 27w), the second row arranged parallel to and spaced apart from the first row (see Fig. 4a, wherein concentric rows are parallel since all tangents are parallel, [0070]), each medicament cavity of the first plurality of medicament cavities in the first row and a corresponding medicament cavity of the second plurality of medicament cavities in the second row forming a pair of medicament cavities (25d, see [0070], [0074]; see also Figs. 6b and 6c); at least one dry powder medicament deposited in at least one medicament cavity of at least one of the first plurality of medicament cavities and the second plurality of medicament cavities (see [0070]; see also [0019]); and a plurality of removable sealing elements (strips 29n1, 29n2, etc., see [0075]); wherein each removable sealing element of the plurality of removable sealing elements is configured to seal to a respective pair of medicament cavities (see [0075], [0073]).
11. Warden discloses the packaging of claim 10, wherein the at least one dry powder medicament includes: a first dry powder medicament deposited in at least one of the first plurality of medicament cavities in the first row; and a second dry powder medicament deposited in at least one of the second plurality of medicament cavities in the second row (see [0070]; see also [0019]).
14. Warden discloses the packaging of claim 10, wherein each removable sealing element of the plurality of removable sealing elements is configured as at least one of a film and a foil [0073].
15. Warden discloses the packaging of claim 10, wherein at least one of: the first plurality of medicament cavities in the first row are arranged contiguously; and the second plurality of medicament cavities in the second row are arranged contiguously (see Fig. 4a, the wells 27w in each row are contiguous).
16. Warden discloses the packaging of claim 10, wherein a number of the first plurality of medicament cavities in the first row is the same as a number of the second plurality of medicament cavities in the second row (see [0070], claim 56, Fig. 4a, the inner and outer rows are configured to form only pairs, thereby having the same number).
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) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Warden in view of Lastow (US 20090250058).
12. Warden discloses the packaging of claim 10, but does not disclose wherein each of the plurality of removable sealing elements are heat-sealed to the respective pair of medicament cavities. Lastow discloses wherein each of the plurality of removable sealing elements are heat-sealed to the respective pair of medicament cavities (see [0027], see also Fig. 3d). 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 sealing of Warden according to the heat seal of Lastow for the predictable result of removably sealing the drug compartments using the well-known, cost-effective method of heat sealing.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Warden in view of Hickey (US 20050103337).
20. Warden discloses a dry powder inhaler (see Fig. 1a) comprising: an inlet (14, see [0083]); an outlet (13, see [0083]); a dosing element (50, see [0084]); and the packaging of claim 10 (see Fig. 1a – 1d). However, Warden does not disclose a dose wheel. Nonetheless, Hickey discloses a dry powder inhaler having an inlet, outlet, dosing element, and disk-shaped packaging (see Fig. 3a, the disk blister pack illustrated as 15), wherein a dose wheel turns the packaging (geared wheel 25, see [0077]). 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 inhaler of Warden to include a dose wheel as taught in Hickey for the benefit of communicating inhaler actuation with effective and reliable transmission via the geared system.
Allowable Subject Matter
Claim 13 is 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 allowance:
Warden, the closest prior art of record, fails to disclose wherein each removable sealing element of the plurality of removable sealing elements is peelable from the respective pair of medicament cavities via application of pressure to a portion of the removable sealing element disposed between the first row and the second row. See for example, Figs. 6a – 6c, [0085], the removable sealing elements are pulled away from the outside of the pairs of medicament cavities. Furthermore, one of ordinary skill in the art would not have been capable of or motivated to peel the respective pair of medicament cavities via the application of pressure as claimed, since the removable sealing elements are configured to be peeled away rather than pressed toward the removable sealing elements. Applying pressure to the removable sealing element disposed between the rows would cause the rows and sealing element to collapse inward, rather than remove the sealing element.
Further relevant prior art includes WO 2009102273, US 20100168710, US 11524128 B2, and US 20100326440.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Please see references cited in the reasons for allowance per above.
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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