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 .
Claim Objections
Claim(s) 16 and 17 is/are objected to because of the following informalities:
Regarding Claim 16, Applicant recites “toward an outlet of the autoinjector in a dispensing operation, when the reservoir with the fluid is received in the housing…” However, the comma separating the two clauses is believed to be extraneous, where the comma punctuation is used to denote separation between clauses – since the “configured to drive” function is believed to be dependent upon the “when the reservoir… is received” clause the use of the comma to separate these clauses is believed to be improper because it grammatically implies independence between the two clauses as opposed to dependency.
Regarding Claim 16, Applicant recites “wherein in the first trigger position, the interface element is releasably locked from moving from the first axial position to the second axial position”. Similar to above the use of the comma here is extraneous as it implies a lack of dependency between the two clauses.
Regarding Claim 16, Applicant recites “in the second trigger position, the interface element is movable to the second axial position”. Similar to above the use of the comma here appears to be extraneous implying independence of the two clauses.
Regarding Claim 17, similar to above the comma in the added limitation is extraneous and impacts clear and concise reading of the claim by implying a separation between the two clauses as opposed to dependency thereof.
Regarding Claim 17, similar to above the comma in the added limitation is extraneous and impacts clear and concise reading of the claim by implying a separation between the two clauses as opposed to dependency thereof.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
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.
Claim(s) 16-21, 25, 28-32 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2019/0209774 (“Schabbach”) as applied above, and further in view of U.S. Publication No. 2018/0021508 (“Destefano).
Regarding Claim 16, Schabbach discloses an autoinjector (10) comprising:
a housing (16, 17) which is configured to receive a reservoir (23) with a fluid;
a squeeze arrangement (inter alia 24) configured to drive the fluid from the reservoir towards an outlet of the autoinjector in a dispensing operation (Par. 79, 91) when the reservoir with the fluid is received in the housing (see Fig. 9);
an outlet (i.e. the distal end of the needle 12);
an interface element (12A) connected to or integrated with the outlet (see Fig. 5);
a trigger (15) operatively connected to the interface element (see Fig. 5); and
wherein the interface element is movable from a first axial position (see Fig. 8B) to a second axial position (see Fig. 9B) along an insertion axis upon actuation of the trigger.
Schabbach discloses the invention substantially as claimed except that that the device comprises a rotatable “holding element” which is rotatable around a rotation axis to provide for release of the interface element/outlet. Instead, Schabbach a linearly driven spring insertion mechanism with a locking mechanism which is pivotable about a locking axis (39).
However, Destefano discloses a related auto-injection device (10) which uses a related needle/interface insertion mechanism which comprises a needle (214) having an interface element (212) connected to an integrated with the outlet of the needle (see Fig. 8B), the interface element being moveable from a first position (Fig. 8B) to a second axial position (Fig. 9B) along a linear axis which serves as a rotation axis about which the insertion mechanism rotates (see Fig. 8A, 9A – Par. 101), the insertion mechanism being activated by a trigger (14) moveable from a first trigger position (i.e. undepressed) to a second trigger position (i.e. depressed) along the rotation axis (i.e. the linear, longitudinal axis serves as the pivot point about which rotation of the housing 202 occurs), wherein in the first trigger position the interface element is releasably locked from moving from the first axial position to the second axial position and in the second trigger position the interface element is movable to the second axial position (Par. 77, 82), wherein the movement of the trigger from the first trigger position to the second trigger position causes the interface element to be released from the first axial position such that the interface element is movable to the second axial position (Par. 111, 114, 118), the mechanism further comprising a holding element (202) in mechanical contact with the interface element (via 204 and 212a) which is rotatable about the longitudinal axis relative to the interface element (see Fig. 8B and 8B) from a blocking position (i.e. prior to depressing of button 14) to a release position (i.e. after depressing of button 14), wherein in the blocking position the interface element is releasably locked by the holding element to prevent the interface element from moving from the first axial position to the second axial position (Par. 118), and in the release position the interface element is movable from the first axial position to the second axial position (Par. 118), and wherein the movement of the trigger from the first trigger position to the second trigger position causes the holding element to rotate from the blocking position to the release position (Par. 111, 114, 118).
It would have been obvious for one having ordinary skill in the art at the time the invention was made to provide the needle inserter of the invention of Schabbach as a selectively releasable rotationally locked driving unit operably advanceable via a torsion spring to cammingly insert the needle, as disclosed by Destefano, as a product of obvious design choice in simple substitution of known, equivalent insertion mechanism, replacing the insertion mechanism in Schabbach with a rotational unlocking mechanism to achieve a predictable and expected outcome. It has been held that simple substitution of known equivalents to obtain a predictable and expected outcome is obvious, see KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Here the ordinary artisan would reasonably recognize and appreciate that the release and advancement mechanism of Destefano is merely an alternative arrangement by which an auto-injection device may be configured to provide for release and insertion of a needle/cannula to bring the device into the operative arrangement to deliver a medicament to a patient. Replacing the pivoting and linear releasing mechanism of Schabbach with a rotationally advancing and releasing mechanism described by Destefano affects only these predictable and expected results.
Regarding Claim 17, Schabbach discloses the squeeze arrangement comprises a movable element (24) which mechanically interacts with the reservoir such that a movement of the movable element causes a squeezing of the reservoir to drive at least a portion of the fluid from the reservoir towards the outlet (Par. 79, 91) when the reservoir with the fluid is received in the housing.
Regarding Claim 18, Schabbach, as modified, discloses a spring (see 25, Schabbach) comprising a spring portion which is configured to rotate around the rotation axis (see Fig. 1, see generally at 16A, Schabbach) and which is mechanically coupled to the movable element (see at 27), such that the spring moves the movable element around the rotation axis (Par. 53 – Schabbach).
Regarding Claim 19, Schabbach discloses the reservoir with the fluid (23),wherein the spring comprises a torsion spring which is configured to move the movable element around the rotation axis such that the fluid contained in the reservoir is moved towards the outlet within one revolution of the movable element around the rotation axis or less (see Fig. 8 and 9 – Par. 98).
Regarding Claim 20, Schabbach discloses the reservoir is arranged circumferentially around the rotation axis, wherein the reservoir is oriented along a circle segment, such that the fluid contained in the reservoir is driven towards the outlet with a rotation of the movable element which comprises less than a full revolution around the rotation axis (see e.g. Fig. 8 – Par. 98).
Regarding Claim 21, Schabbach discloses the reservoir comprises a collapsible pouch (26).
Regarding Claim 25, Schabbach discloses a delivery tube which is in fluid communication with the reservoir, and which is arranged between the reservoir and the outlet, wherein the delivery tube supplements fluid to the outlet being provided by the reservoir during a dispensing operation (Par. 21).
Regarding Claim 28, Schabbach, as modified in view of Destefano (see above) discloses (see Destefano an outlet drive unit (210) operatively connected to the trigger and to the interface element, wherein the outlet drive unit is being configured to provide energy for moving the interface element from the first axial position to the second axial position, wherein the outlet drive unit has a first drive unit state and a second drive unit state, wherein in the first drive unit state the outlet drive unit has energy stored and the interface element is in the first axial position and the holding element is in the blocking position and the interface element is prevented from moving to the second axial position, and in the second drive unit state the outlet drive unit transfers energy to the interface element so that the interface element is moved the first axial position to the second axial position along the rotation axis when the holding element is in the release position, wherein the movement of the trigger from the first trigger position to the second trigger position causes the outlet drive unit to change from the first drive unit state to the second drive unit state (Par. 102, 103, 108, 118).
Regarding Claim 29, Schabbach discloses the autoinjector comprises the reservoir with a medicament or drug (see Fig. 1, 8).
Regarding Claim 30, the invention of Schabbach is disposable or single-use device, for providing a single dose (Par. 94).
Regarding Claim 31, Schabbach discloses the squeeze arrangement comprises a movable element (24) which mechanically interacts with the reservoir such that a movement of the movable element causes a squeezing of the reservoir to drive at least a portion of the fluid from the reservoir towards the outlet, the movable element comprises a roller, which is configured to rotate around a roller axis while it is rotating at the same time around the rotation axis and squeezes the reservoir, wherein the roller comprises a shape of a cylinder (see Fig. 1, 8; Par. 79, 91).
Regarding Claim 32, Examiner notes that Claim 32 can be satisfied by the alternative case wherein the shape of the roller is a cylinder, as such further limitations directed toward narrowing of the optional second case (i.e. if the roller is a cone) fail to define and distinguish over Schabbach.
Claim(s) 22-24 and 34-35 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2019/0209774 (“Schabbach”) as applied above, and further in view of U.S. Publication No. 2018/0021508 (“Destefano) as applied above, and further in view of U.S. Patent No. 612,834 (“Dieckman”).
Regarding Claims 22 and 34-35, Schabbach discloses the invention substantially as claimed except that that the housing comprises a “supporting element” in the form of a “protrusion” protruding from a bottom of the housing toward the reservoir, with the reservoir arranged between the supporting element and the moveable element to permit the reservoir to be squeezed by the moveable element as a surface of the reservoir is pressed toward the supporting element. However, Dieckman discloses a related squeeze arrangement (see Fig. 1-3) wherein the pump housing comprises a curved supporting element (a) in form of a protrusion protruding from a bottom of the housing towards the reservoir (c – see Fig. 2), wherein the reservoir is arranged between the supporting element and the movable element (g) along a parallel curve path to that of the supporting element such that when the reservoir is squeezed by the movable element a surface of the reservoir is pressed towards the supporting element (see Fig. 2 and 3). It would have been obvious for one having ordinary skill in the art at the time the invention was made to provide a protruding supporting element to the housing of Schabbach, as disclosed by Dieckman, in order to create a seat for the reservoir to serve to assist in compression of the reservoir while preventing the reservoir from slipping or create poor apposition with the roller element.
Regarding Claim 23, Schabbach discloses the movable element comprises a roller (24), which is configured to rotate around a roller axis while it is rotating at the same time around the rotation axis and squeezes the reservoir (Par. 100).
Regarding Claim 24, Schabbach discloses the roller comprises a shape of a cylinder (see Fig. 2).
Response to Arguments
Applicant's arguments filed with respect to the claims have been fully considered but they are not persuasive.
Applicant argues that “the hub 212 of DeStefano is not biased, so it does not need to be locked…” (Pg. 3). However, this is not persuasive. Specifically, as disclosed in Par. 118, Destefano discloses “unwiding and/or de-energizing of rotation biasing member 210 causes housing 202 to rotate about axis A (see Fig. 3A). As housing 202 rotates, contact of the guide surfaces 204 with extension arms 212A of the needle hub 212 causes hub 212 to translate in the distal direction”. As such, it is clear that that the housing (202) is biased by the rotation biasing member (210) which affects the corresponding linear advancement of the hub (212). As such, it must be understood that the hub (212) is biased by the rotation biasing member (210) whereby locking of the assembly to prevent release of this bias prior to the desired advancement of the hub is necessary and provided for by trigger (14) and holding element/housing (202). Hub (212) is maintained or “locked” in the retracted position (see Fig. 8B) UNTIL the trigger is depressed in order to affect insertion of the hub and needle (see Fig. 8B and 9B in series). This is certainly a type of locking arrangement which prevents the interface element from moving from the first axial position to the second axial position as claimed. Specifically, the housing/holding element guide surfaces maintain the hub (212) position until the spring energy is released and the holding element rotates in order to cam the hub forward advancing the cannula (Par. 101). Prior to release the position of the hub is static, i.e. locked.
Applicant argues (Pg. 9) “a movement of the hub 212 of DeStefano is completely independent from the position of the housing 202”. However, this is not persuasive as the specification of DeStefano makes it clear that advancement of the hub (212) is dependent upon rotation of the housing (202) in order for the guide surfaces (204) to cam the extension arms (212) which “causes or permits the hub to axially translate…” [emphasis added] (Par. 101).
As such, the locking and insertion mechanism of DeStefano reads upon the instantly claimed subject matter because the hub does not move until the bias of the rotational biasing member causes it to move.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM R CARPENTER whose telephone number is (571)270-3637. The examiner can normally be reached Mon. to Thus. - 7:00AM to 5:00PM (EST/EDT).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, KEVIN SIRMONS can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783 10/01/2026
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