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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Objections
Claims 4, 9 objected to because of the following informalities:
Claim 4 line 4 recites “the inhaler” should be -the powder inhaler-
Claim 9 line 3 and line 5 recites “the inhaler” should be -the powder inhaler-
Appropriate correction is required.
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.
Claim 1-10 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.
Claim 1 has numerous instances of claim antecedence issues and various confusion on where structure is introduced multiple times. Line 2 recites “a reservoir”, “a cavity”, “a dose of powder”, “a closing layer”, but then further recites in lines 9-10 “a first reservoir”, “a first dose”, “a second reservoir”, “a second dose”; thus adding confusion between those limitations. Furthermore, claim 1 line 4 recites “two support portions” and then in line 8 recites “a support portion” (having lack of clarity to which of the two), and then further recites “a first support portion” and “a second support portion” providing confusion if this is meant to be the same support portion. As such claim 1 is rejected under 112b for lack of clarity and indefinite issues relating to claim structure antecedence. Examiner provides a recommended amendment herein and how the claim will be essentially interpreted:
A powder inhaler, comprising a body for receiving a first and second reservoir each having a corresponding first and second cavity each containing a first and second dose of powder and a first and second closing layer to sealingly close each said first and second cavity, characterized in that said body has a head portion and two support portions, said head portion being connected to each of said two support portions by at least one joint, said head portion having a dispensing opening and a perforating element connected to said dispensing opening, which perforating element is designed, when actuated, to pierce said first and second closing layer to open said first and second reservoir arranged on each of said two support portions, a first support portion of said two support portions for receiving the first reservoir containing the first dose and a second support portion of said two support portions for receiving the second reservoir containing the second dose, said body being formed of a single piece.
Claim 3 recites the limitation "each joint" in line 2. There is insufficient antecedent basis for this limitation in the claim, also there is a proper lack of usage of “the” or “said”. Claim 1 recites “at least one joint”. Claim 3 will be interpreted as “wherein said at least one joint is formed”.
Claim 4 recites “each support portion” in line 3, wherein this lacks proper antecedent basis to claim 1. Will be interpreted as “said two support portions each have at least one projection”.
Claim 4 and 5 recites the limitation "the closed position" and “said closed position”. There is insufficient antecedent basis for this limitation in the claim.
Claim 5 recites “several reservoirs”, wherein claim 1 only recites at most two reservoirs in regards to the “first reservoir” and “second reservoir”. It is unclear if claim 5 is referring to specifically back to those reservoirs or some other reservoir. Examiner will interpret this as “to enable the body to be reused with the first and second reservoirs”.
Claim 6 recites “each support portion” in line 2, wherein this lacks proper antecedent basis to claim 1. There are also issues with “said cavity” and “said reservoir” having antecedence issues going back to claim 1. Will be interpreted as “said two support portions each have a corresponding first and second recess adapted to house said first and second cavity of said first and second reservoirs” (in accordance with claim 1 suggestions above).
Claim 7 recites “said reservoir” in line 2, lacking proper antecedence to claim 1. Claim 7 further recites “each support portion” in line 3, wherein this lacks proper antecedent basis to claim 1. Examiner will interpret claim 7 as “said first and second reservoir has… said two support portions each having”.
Claim 8 recites “said reservoir” in lines 2 and 3, lacking proper antecedence to claim 1. Further recites “a support portion” in line 2 and “said support portion” in line 3 having a lack of clarity to which support portion. Examiner will interpret claim 8 as “wherein after positioning said first and second reservoirs on a corresponding one of said two support portions, each stud is deformed, in particular snapped, to non-removably fix said first and second reservoirs on said two support portions”.
Claim 8 recites the limitation "each stud". There is insufficient antecedent basis for this limitation in the claim. Examiner will interpret this as -each said at least one stud-.
Claim 9 recites “said closing layer of said reservoir” in line 4 having confusion for to which reservoir this could be referring. Examiner will interpret this as “said first and second closing layer of said first and second reservoirs” (in accordance with claim 1 suggestions).
Claims 2 and 10 are rejected as being dependent on claim 1.
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.
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.
Claims 1-3 and 6-10 are rejected under 35 U.S.C. 103 as being unpatentable over Beller (US 20160346490 A1) in view of Ren (CN 113018612 A) (see attached translation).
Regarding claim 1 and 10, Beller discloses a powder inhaler (1) (Fig. 1-9, title, powder inhaler 1),
comprising a body (body 3,4) (Fig. 1-9) for receiving a reservoir (100) having a cavity (101) containing a dose of powder (Fig. 2a-2b, [0062] body 3,4 receivers a blister packet 100 being a reservoir containing a dose of powder in a cavity/ingredient depression 101) and a closing layer (cover film) to sealingly close said cavity (101) (Fig. 1-9 and [0073] blister packet 100 has a cover film being a closing layer), characterized in that said body (3,4) has a head portion (3) and a support portion (4) (Fig. 1-9),
said head portion (3) being connected to each support portion (4) by at least one joint (16) (Fig. 1-9),
said head portion (3) having a dispensing opening (20/21) (Fig. 7-9, [0076] curved nose tube 21 dispensing the powder; Fig. 1-5, [0064] mouthpiece 20) and a perforating element (pricker 10, [0073], Fig. 1-5, pricker 10 perforates) connected to said dispensing opening (20/21) (Fig. 1-5, the pricker 10 is part of the head portion 3 thus is connected to the dispensing opening 20/21), which perforating element (10) is designed, when actuated, to pierce said closing layer (cover film) to open said reservoir (100) arranged on a support portion (4) (Fig. 1-5 and [0073], pricker 10 when actuated punctures the cover film of the blister packet 100 for open the reservoir/cavity holding the dose of powder),
a first support portion (4) for receiving a first reservoir (100) containing a first dose (Fig. 1-9, there is a first support portion 4 with a first reservoir 100 having the first dose), and
said body (3,4) being formed of a single piece (Abstract and [0058] the powder inhaler 1 and thus body 3,4 is formed as a single-piece structure by injection molding).
Beller does not disclose two support portions, a second support portion for receiving a second reservoir containing a second dose (claim 1), and wherein said two support portions are arranged symmetrically on either side of said head portion (claim 10)
However, Ren teaches an analogous powder inhaler (1) (Fig. 1-5, abstract, inhaler for powder) comprising an analogous head portion (11) having a dispensing opening (Fig. 3a) and an analogous support portion (2) (Fig. 1-9) containing an analogous dose of powder (Page 5), wherein there may be two support portions (2) being a first support portion having a first dose of powder and a second support portion containing a second dose of powder arranged symmetrically on opposite sides of the head portion (11) (Fig. 3a and Page 6), wherein each support portion (2) is further analogous connected to the head portion (11) by a pivot connection (Fig. 1-5 and claim 1, abstract).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have provided a second support portion (4) of Beller arranged on an opposite side of the head portion (3) as taught by Ren to provide two support portions, a second support portion for receiving a second reservoir containing a second dose, and wherein said two support portions are arranged symmetrically on either side of said head portion and thus provide an improved inhaler able to prepare and deliver two doses of powder (Ren Fig. 3a-3b and Page 6) and since it has been held that duplication of parts “has no patentable significance unless a new and unexpected result is produced” (see In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960)) (see MPEP 2144.04 VI B).
Regarding claim 2, Beller in view of Ren discloses the invention of claim 1 above.
Beller further discloses wherein said dispensing opening (21) is formed at the axial end of a nasal endpiece intended to be inserted into a nostril during actuation (Fig. 6 and [0076-0077], the dispensing opening 21 may be an opening formed at an axial end of the nasal endpiece/curved tube as shown in Fig. 6 to be inserted into a nostril during actuation).
Regarding claim 3, Beller in view of Ren discloses the invention of claim 1 above.
Beller further discloses wherein each joint (16) is formed by a bridge of foldable material (Fig. 1-9 and [0070] joint 16 is a film hinge being a bridge of foldable material).
Regarding claim 6, Beller in view of Ren discloses the invention of claim 1 above.
Beller further discloses wherein each support portion (4) has a recess (9) adapted to house said cavity 101 of said reservoir (100) (Fig. 1-5 and [0062] depression/recess 9).
Regarding claim 7, Beller in view of Ren discloses the invention of claim 1 above.
Beller further discloses wherein said reservoir (100) has at least one positioning opening (103) (Fig. 2b and [0066] opening 103), each support portion (4) having at least one stud (18’) for receiving a respective positioning opening (103) (Fig. 2b and [0066], stud/projection extends through the opening 103).
Regarding claim 8, Beller in view of Ren discloses the invention of claim 7 above.
Beller does not explicitly recite wherein after positioning said reservoir on a support portion, each stud is deformed, in particular snapped, to non-removably fix said reservoir on said support portion.
However, Examiner notes this is an apparatus claim and not a method claim and as such the device of Beller must be merely capable of undergoing the recited functional language of the present application. As Beller does disclose the stud 18’ being a plastic stud ([0058] device is formed of injection molded plastic as one piece, analogous synthetic material) for the same disclosed/claimed function as discussed in claim 7, then the stud 18’ would be capable of undergoing the same plastic deformation/snapping as claimed to non-removably fix said reservoir on said support portion as it is made of material capable of undergoing the same deformation/snapping as claimed as it is also a stud positioning the analogous reservoir (100) (Fig. 1-5 of Beller).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have understood that the stud 18’ of Beller would implicitly have the capability of the claim language of “wherein after positioning said reservoir on a support portion, each stud is deformed, in particular snapped, to non-removably fix said reservoir on said support portion” due to be the substantially same disclosed structure, See MPEP 2112.01(I) which states “when the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent”.
Regarding claim 9, Beller in view of Ren discloses the invention of claim 1 above.
Beller further discloses wherein said head portion (3) has at least one blocking tab (14) for locking the inhaler in an intermediate position in which said perforating element (10) has not pierced said closing layer (cover film) of said reservoir (100), such that during actuation, the user must break or deform said at least one blocking tab (14) in order to be able to actuate the inhaler (Beller Fig. 5 and [0073], there is an elastic insert 14 being a blocking tab that in its unactuated state keeps the inhaler in an intermediate position of being folded but not yet actuating the perforating element (14) for release of the dose of powder, the elastic insert 14 thus can be deformed to in order to actuate the inhaler and perforating element 14 in order to penetrate the closing layer/cover film of the reservoir 100).
Claims 4 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Beller (US 20160346490 A1) in view of Ren (CN 113018612 A) (see attached translation), in further view of Lastow (US 20200230332 A1).
Regarding claim 4, Beller in view of Ren discloses the invention of claim 1 above.
Beller does disclose a closed position of the inhaler (Fig. 3-5 and 6-7).
Beller/Ren does not disclose wherein said head portion has at least one window and each support portion has at least one projection for engaging in the closed position of the inhaler with a respective window, in particular by snap-fitting, to lock said closed position.
However, Lastow teaches an analogous powder inhaler (title) having an analogous body 11/12 wherein the two parts 11/12 of body are connected by an analogous foldable bridge joint 40 (Fig. 1-6 and abstract, and [0035]) to fold into an analogous closed position (Fig. 5-6), wherein the part 12 as analogous head portion has at least one window (21) (Fig. 1-6, [0057] aperture/windows 21), the part 11 as an analogous support portion has at least one projection (22) (Fig. 1-6 and [0057]) for engaging in the closed position of the inhaler with a respective window (21), in particular by snap-fitting, to lock said closed position (Fig. 1-6 and [0057] the projections 22 snap latch into the windows to lock into a closed fold position).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have provided to the invention of Beller wherein said head portion of Beller has at least one window and each support portion of Beller/Ren has at least one projection for engaging in the closed position of the inhaler with a respective window, in particular by snap-fitting, to lock said closed position as taught by Lastow in order to provide a lock to the folded position that is of less complex and cost efficient assembling process (Lastow [0057]).
Regarding claim 5, Beller in view of Ren and Lastow discloses the invention of claim 4 above.
Lastow as combined further teaches wherein said locking of the closed position is unlockable, to enable the body to be reused with several reservoirs ([0057] the latching of projections 22 and window 21 is of elastic deformation, thus is capable of being unlocked through separating the two with force) (see teachings of Ren in claim 1 above wherein the body is built to be reused with a second reservoir).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Beller (US 20160346490 A1) in view of Ren (CN 113018612 A) (see attached translation), in further view of Narodylo (DE 19523516 C1) (see attached translation).
Regarding claim 9, Beller in view of Ren discloses the invention of claim 1 above.
As an additional interpretation, Beller/Ren discloses wherein said head portion has at least one blocking tab for locking the inhaler in an intermediate position in which said perforating element has not pierced said closing layer of said reservoir, such that during actuation, the user must break or deform said at least one blocking tab in order to be able to actuate the inhaler (see above 103 of claim 9).
However, Narodylo further teaches an analogous powder inhaler (Fig. 1-10) comprising an analogous head portion (2) comprising an analogous perforating element (4) (Fig. 2-4), and an analogous supporting portion (29) holding a reservoir (31) having a dose of powder (Fig. 2-4), wherein said head portion (2) has at least one blocking tab (6) (Fig. 2-4 and Page 6, elastic webs are “tabs” of material that block the inhaler into the position of Fig. 3) for locking the inhaler in an intermediate position in which said perforating element has not pierced said closing layer of said reservoir, such that during actuation, the user must break or deform said at least one blocking tab in order to be able to actuate the inhaler (Fig. 2-4 and Page 6, elastic webs/blocking tab 6 locks the inhaler in the intermediate position of 3 such that the perforating element (4) is not engaging and bursting the blister pack 5/31 with the dose of powder, during actuation, the user must further apply force to the elastic web to deform/bend the web 6 in order to actuate and pierce the blister pack as shown).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have provided the elastic web/blocking tab 6 to the head portion of Beller/Ren as taught by Narodylo in order to provide an improved user actuation as the biasing force of the elastic web/blocking tab 6 would ensure the dose of powder does not get accidently pierced (Narodylo Fig. 2-4 and Page 6).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEVIN S ALBERS whose telephone number is (571)272-0139. The examiner can normally be reached Monday-Friday 7:30 am to 5:00 pm.
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/KEVIN S ALBERS/Patent Examiner, Art Unit 3786
/KERI J NELSON/Primary Examiner, Art Unit 3786
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