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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/26/2026 has been entered.
Response to Amendment
The amendment filed 02/26/2026 has been entered. Claims 1, 3, 5, 9, 11 and 47-60 are pending in the application.
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, 3, 5, 9, 11, 47-60 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kemp (US 2018/0147360).
Regarding claim 1, Kemp discloses an injection device comprising: a housing (2.1, Fig 10) having an opening (Opening in 2.1, Fig 10); a drug storage container (3, Fig 10) including a delivery member (4, Fig 10) having an insertion end configured to extend at least partially through the opening in the housing (See Fig 12); a plunger (10, Fig 10) including a flange (10.1, Fig 7A) extending radially outwardly from the plunger (See Fig 4); a sleeve (2.2, Fig 10) fixedly attached to the housing and including an angled camming surface (2.5, Fig 7A); a biasing member (9, Fig 4) operably coupled to the plunger and initially retained in an energized state, wherein releasing the biasing member drives the plunger to expel a drug from the drug storage container through the delivery member (Para 0074); a guard member (7, Fig 10) having a skin-contacting portion (distal facing surface of needle shroud 7, Fig 3) and an activator portion (proximal-most surface of 7.1, Fig 8C), the skin-contacting portion being integrally formed with the activator portion to define a single, monolithic structure (See Fig 3), the guard member being moveable relative to the housing and having an extended position wherein the guard member extends at least partially through the opening in the housing (Position seen in Fig 11) and a retracted position wherein the guard member is positioned away from the extended position toward the housing (Position seen in Fig 12), wherein moving the guard member from the extended position to the retracted position causes the activator portion to release the biasing member to allow the biasing member to drive the plunger to expel the drug from the drug storage container (Para 0068, 0072-0074); and a retaining member (14.1, Fig 7A) having a first position wherein the retaining member prevents the flange from sliding down the angled camming surface and retains the biasing member in the energized state (Position shown in Fig 7A) and a second position wherein the retaining member is freed from retaining the biasing member and allows the flange to slide down the angled camming surface under a biasing force of the biasing member (Position show in Fig 7D), wherein the activator portion acts on the retaining member to move the retaining member from the first position to the second position when the guard member moves from the extended position to the retracted position (Para 0070-0074).
Regarding Claim 3, Kemp discloses (a) the activator portion (proximal-most surface of 7.1, Fig 8C) directly contacts the retaining member (14, Fig 8C) to move the retaining member from the first position to the second position (Para 0078-0079).
Regarding Claim 5, Kemp discloses the activator portion is configured to retain the biasing member in the energized state when the guard member is in the extended position (Para 0070-0074).
Regarding Claim 9, Kemp discloses the skin-contacting portion and the activator portion jointly translate in a linear direction between the extended position and the retracted position (Para 0078-0081; as the skin-contacting portion and the activator portion are monolithic, they necessarily jointly translate in a linear direction.)
Regarding Claim 11, Kemp discloses the guard member includes a tubular portion (distal tubular portion best seen in Fig 3) and at least one longitudinally extending arm (arms 7.1) extending away from the tubular portion, an end surface of the tubular portion defining the skin-contacting portion (See Fig 3).
Regarding Claim 47, Kemp discloses a releaser member (14.3, 14.4, Fig 8A) configured to rotate (“deflect inward”) under a biasing force exerted by the biasing member, wherein the activator portion is configured to resist rotation of the releaser member when the guard member is in the extended position (Para 0077-0080).
Regarding Claim 48, Kemp discloses the activator portion (proximal-most surface of 7.1, Fig 8C) directly contacts the releaser member when the guard member is in the extended position (See Fig 8B) and wherein the activator portion is spaced from the releaser member when the guard member is in the retracted position (See Fig 8F).
Regarding Claim 49, Kemp discloses the releaser member (14.3, 14.4, Fig 8A) is fixed to or integrally formed with the plunger (10, Fig 5) (Merriam-Webster dictionary defines integrally as “formed as a unit with another part”. As auto injector is a singular unit made up of all its part, the release member and plunger are parts integral to the unit).
Regarding Claim 50, Kemp discloses the guard member (7, Fig 10) has a partially retracted position between the retracted position and the extended position, the activator portion being configured to retain the biasing member in the energized state when the activator portion is in the partially retracted position (Para 0072).
Regarding Claim 51, Kemp discloses the skin-contacting portion (distal facing surface of needle shroud 7, Fig 3) and the activator portion (proximal-most surface of 7.1, Fig 8C) are integrally formed to define a single, monolithic structure (See Fig 3).
Regarding Claim 52, Kemp discloses the activator portion (proximal-most surface of 7.1, Fig 8C) is defined at least in part by a wall extending inwardly from the at least one longitudinally extending arm (7.1, FIG 3) (the proximal-most surface has a depth as seen in Fig 8C and thus extends inwardly).
Regarding Claim 53, Kemp discloses the biasing member (9, Fig 4) includes a spring (Para 0062).
Regarding Claim 54, Kemp discloses the insertion end of the delivery member is surrounded by the guard member when the guard member is in the extended position (See Fig 11) and the insertion end of the delivery member protrudes outside of the guard member when the guard member is in the retracted position (See Fig 13).
Regarding Claim 55, Kemp discloses the retaining member (14.1, Fig 7A) abuts the flange (10.1, Fig 7A) when the retaining member is in the first position (See Fig 7A).
Regarding Claim 56, Kemp discloses the plunger (10, Fig 4) is configured to rotate relative to the sleeve as the flange slides down the angled camming surface (2.5, Fig 7A) when the retaining member is in the second position (Para 0070-0074).
Regarding Claim 57, Kemp discloses the flange (10.1, Fig 7A) is integrally formed with the plunger (10, Fig 4) such that the flange moves jointly with the plunger (Para 0073).
Regarding Claim 58, Kemp discloses the sleeve (2.2, Fig 10) includes a longitudinally extending slot (2.4, Fig 7A) configured to receive the flange after the flange slides down the angled camming surface (See Fig 7D).
Regarding Claim 59, Kemp discloses the guard member (7, Fig 3) is not in contact with the retaining member (14.1, Fig 8A) when the retaining member is in the first position (Para 0078; as the guard member never directly contacts the retaining member 14.1 but joints 14.3 of the collar 14, this is true is any position).
Regarding Claim 60, Kemp discloses the activator portion (proximal-most surface of 7.1, Fig 8C) of the guard member is in contact with the retaining member (14.1, Fig 8B) when the retaining member is in the first position (See Fig 8B; the activator and retaining member are at least indirectly coupled to one another through snap-fit joints 14.3).
Response to Arguments
Applicant’s arguments filed 02/26/2026, on pages 7-9, regarding Kemp failing to teach the amended limitations of claim 1 have been fully considered but are not persuasive. Under the new interpretation of Kemp as detailed above, the flange is 10.1 of plunger 10 and the sleeve is rear case 2.2 (which is distinct and fixed to front cases/housing 2.1). With this interpretations, Kemp teaches a retaining member (14.1, Fig 7A) having a first position wherein the retaining member prevents the flange from sliding down the angled camming surface and retains the biasing member in the energized state (Position shown in Fig 7A) and a second position wherein the retaining member is freed from retaining the biasing member and allows the flange to slide down the angled camming surface under a biasing force of the biasing member (Position show in Fig 7D), wherein the activator portion acts on the retaining member to move the retaining member from the first position to the second position when the guard member moves from the extended position to the retracted position (Para 0070-0074). Therefore, Kemp still reads on the amended claim limitations.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANTARIUS S DANIEL whose telephone number is (571)272-8074. The examiner can normally be reached M-F 7:00am to 4:30pm EST.
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/ANTARIUS S DANIEL/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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