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
Claim 3 is objected to because of the following informalities: in line 1, “display element” should be “rotating display element”. Appropriate correction is required.
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.
Claims 1, 2, 4-7, 9, 10, and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Olson (US 2014/0330214).
Regarding claim 1, Olson discloses:
An autoinjector (Fig. 9), comprising: a housing (2, 3, 5) having a longitudinal axis configured to accommodate a product container (12; Fig. 5); a propulsion member (32; Fig. 3); a drive element (60) configured to be rotatable (¶0075) to move the propulsion member (32) along the longitudinal axis for automatically discharging a liquid product contained in the product container (12) through an injection needle (13) (¶0079 – “driver 32 comprises a threaded structure 38 that engages with the threads 63 of the plunger rod 60”); a display (Fig. 12) configured to signal a progression of a discharge (¶0085 – “Through the transparent cap 180, the user can see a signalling element in the form of a rotatable element, such as a wheel or disk 182”), the display (Fig. 12) comprising a rotating display element (182; Fig. 10) configured to be driven by the drive element (¶0086), a rotatable optical contrast pattern (190, 192; ¶0087), and a window (180) at a proximal end of the autoinjector (Fig. 9) through which the rotatable contrast pattern (190, 192) is visible (¶0087), wherein the window (180) is configured as an uninterrupted window circumferentially surrounding the longitudinal axis (Fig. 12 – the body of window 180 is a continuous and transparent window that does not include the openings 181).
Regarding claim 2, Olson discloses:
The autoinjector of claim 1, wherein the rotating display element (182) is configured to be driven directly by the drive element (60) (Fig. 10; ¶0086 – driver 50 includes drive element 60).
Regarding claim 4, Olson discloses:
The autoinjector of claim 1, wherein no optical marking is provided for determining a rotational position of the contrast pattern (Fig. 12 – the display element 182 only has uniform segments 190, 192 around the circumference of the element 182).
Regarding claim 5, Olson discloses:
The autoinjector of claim 1, wherein the rotating display element (182) is configured to generate a discharging sound during the discharge (¶0090 – rotation causes audible sound).
Regarding claim 6, Olson discloses:
The autoinjector of claim 5, wherein the discharging sounds comprised clicking sounds generated by an axially resilient engagement element (200) (¶0090 – clicks are caused by arms 200 hitting ledges of element 182).
Regarding claim 7, Olson discloses:
The autoinjector of claim 6, wherein no independent optical, acoustic, and/or tactile signaling of an end of the discharge is provided (¶0090, 0095 – in the embodiment being relied on, rotation, sounds, and tactile signals stop at the end of injection).
Regarding claim 9, Olson discloses:
The autoinjector of claim 1, further comprising: a needle protection sleeve (17; Fig. 3) projecting distally over the housing (2, 3, 5) in a delivery state of the autoinjector, wherein when the autoinjector is pressed against a point of injection (¶0051), the needle protection sleeve (17) carries out an actuation movement in a proximal direction (¶0060) and, when the autoinjector is removed from the point of injection (¶0052), carries out a needle protection movement in a distal direction in order to laterally surround the injection needle (13) with a sleeve-shaped portion (distal end of sleeve 17), and wherein the needle protection sleeve (17) comprises an annular flange (18) at a distal end for contact with the point of injection with a maximum diameter that is greater than a maximum diameter of the sleeve-shaped portion (Fig. 2).
Regarding claim 10, Olson discloses:
The autoinjector of claim 9, wherein an outer edge of the flange (18) is adapted to a distal opening in the housing (2) (Fig. 7 – the flange 18 sits outside and slightly wider than the distal end of housing part 2).
Regarding claim 12, Olson discloses:
The autoinjector of claim 9, wherein the drive element (60) is a threaded rod (¶0075) and the propulsion member (32) comprises a propulsion sleeve (32) and an axial guide element (39) for an exclusively linear propulsion movement (¶0064) in the housing (2, 3, 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.
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.
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 3 is rejected under 35 U.S.C. 103 as being unpatentable over Olson.
Regarding claim 3, Olson discloses the autoinjector of claim 2 but is silent regarding the speed of the display element being “less than one revolution per second during the discharge.” However, Olson discloses that the user can see the rotation of the display element (182) to readily discern that the device works properly and that the injection is in progress (¶0086). In addition, it is known to a person of ordinary skill in the art that the rotation of the drive element would depend on the speed of injection, which is limited by the density of the medication, pain of injection, and similar design features. As such, depending on these factors, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have a rotational speed of less than one revolution per second during discharge in order to clearly see the proper function of the device and also to provide a device that delivers the drug at an optimum speed.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Olson in view of Julian et al (US 2010/0160894).
Regarding claim 8, Olson discloses the autoinjector of claim 1 and further discloses the window (180) comprising a first region parallel to the longitudinal axis and a second region seamlessly adjoining the first region with a constantly decreasing diameter in a proximal direction in the form of a tapering closed end of the cap that forms the window (180). However, Olson is silent regarding the regions being cylindrical, as the proximal end of the injector of Olson is square-shaped. However, Julian teaches an autoinjector (Fig. 1), thus being in the same field of endeavor, with a cylindrical shape. The window of Olson would have a cylindrical window if it incorporated the cylindrical shape taught by Julian, with the outer shape of the autoinjector being known as a design consideration to a person of ordinary skill in the art. It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have made the injector of Olson cylindrical as taught by Julian as a matter of design choice, which would result in cylindrical regions of the window as it tapers.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Olson in view of Germinario et al (US 2017/0319796).
Regarding claim 13, Olson discloses the autoinjector of claim 9 but is silent regarding “the product container and the injection needle is configured as a pre-filled, ready-to-use syringe with a filling volume of at least 3 ml.” However, Germinario teaches a drug delivery device (Abstract), thus being in the same field of endeavor, with a product container in the form of a prefilled syringe with a volume of at least 3 ml (¶0245). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have provided the product container of Olson as a prefilled syringe with a volume of at least 3mL as taught by Germinario in order to provide sufficient structure for deliver a specific medication.
Allowable Subject Matter
Claim 11 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TASNIM M AHMED whose telephone number is (571)272-9536. The examiner can normally be reached M-F 9am-5pm Pacific time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at (571)272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TASNIM MEHJABIN AHMED/Primary Examiner, Art Unit 3783
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