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 .
Response to Amendment
The objections to the specification are withdrawn in light of amendments.
The rejections pursuant to 112(b) with respect to claims 2-5 are withdrawn in light of amendments.
Response to Arguments
Applicants’ arguments filed on 06/23/2026 have been fully considered.
With regards to applicants’ argument under “Claim Rejections - 35 USC § 102” on pages 7-8 of Remarks for claims 1-3 and 6-12, have been fully considered but they are not persuasive. In response to applicants’ argument that the claimed “shroud” and the enlarged rim section disclosed in Markussen are not the same and that Markussen discloses no component that is a protective cover for the needle that is driven proximally by the intermediate member, claim 1 does not require the shroud to be a protective cover for a needle. Rather, claim 1 recites a shroud and that the plunger selectively transmits force from the drive means to the shroud. The enlarged rim section of Markussen corresponds to the claim shroud because it surrounds the plunger (See annotated Fig.1a below) and the plunger selectively transmits force from the drive means to the plunger and from the drive means to the shroud, as recited in the Non-Final Office Action.
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In response to applicants’ argument that the mechanism of Markussen requires two separate springs for two separate functions and that spring 360 does not drive any component to cover or shield the needle-that function is performed entirely by the separate shielding spring 370, claim 1 does not require the shroud to cover the needle or require the drive means to drive the shroud for purposes of covering a needle. Rather, claim 1 cites that the plunger selectively transmits force from the drive means to the shroud. As stated above, even though Markussen requires two separate springs, the plunger selectively transmits force from the drive means (spring 360) to the plunger and from the drive means to the shroud, as recited in the Non-Final Office Action.
With regards to applicants’ argument under “Claim Rejections - 35 USC § 103” on pages 8-9 of Remarks for claims 4-5, have been fully considered but they are not persuasive due to the same reasons as stated above.
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 pre-AIA 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3 and 6-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Markussen et al. (US 20130218093 A1, herein, Markussen).
Regarding claim 1, Markussen discloses an injection device comprising:
i) a drive means (360 – Fig.1a);
ii) a plunger (321 – Fig.1a);
iii) a shroud (311- Fig.1f); and
iv) an intermediate member (330 – Fig.1b) disposed between the drive means and the plunger (Fig.1b) and releasably engaged (300 – Fig.1b) with the plunger thereby to selectively transmit force from the drive means to the plunger (“actuator thrust member is moved distally forcing the actuator connector, the piston driver… forward” – Para [0125]) and from the drive means to the shroud (Fig.1a-Fig.1f, “piston driver enlarged rim section 311 abuts the rim section” – Para [0127]) and to drive the shroud proximally when transmitting force from the drive means to the shroud (Fig.1f, “the piston driver has been moved to its stop relative to bushing member and cartridge” – Para [0128]).
Regarding claim 2, Markussen discloses an injection device as recited above, wherein the intermediate member (330 – Fig.1b) has a compressed configuration (Fig.1b) and a relaxed configuration (Fig.1g, Fig.1h) wherein in the compressed configuration the intermediate member is in engagement with the plunger to transmit force from the drive means to the plunger (Fig.1a, “deflectable head portions to cooperate with enlarged head of actuator connector” – para [0120]) and in the relaxed configuration the intermediate member is released from engagement with the plunger such that force is not transmitted from the drive means to the plunger (“the connection between the deflectable head portions and the enlarged head of actuator connector is discontinued” – Para [0128]).
Regarding claim 3, Markussen discloses an injection device as recited above, wherein the injection device further comprises a housing (200 – Fig.1c) arranged to selective maintain the intermediate member in the compressed configuration (Fig.1b).
Regarding claim 6, Markussen discloses an injection device as recited above, wherein the intermediate member comprises an outer portion and an inner portion connected by a connecting portion (See Annotated Fig.2 below).
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Regarding claim 7, Markussen discloses an injection device as recited above, wherein the outer portion comprises one or more flexible fingers (332 – Fig.1d, “deflectable” – Para [0120]).
Regarding claim 8, Markussen discloses an injection device as recited above, wherein the flexible fingers or non-contiguous wall portion are closer together in the compressed configuration (Fig.1b) than the relaxed configuration (Fig.1g, Fig.1h).
Regarding claim 9, Markussen discloses an injection device as recited above, wherein the intermediate member is provided with an angled surface which contacts a corresponding angled surface of the plunger (See annotated Fig.1a below).
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Regarding claim 10, Markussen discloses an injection device as recited above, wherein the intermediate member comprises an outer portion and an inner portion connected by a connecting portion (See annotated Fig.2 below); the outer and inner portion extending distally from the connecting portion to receive the proximal end of the drive means (Fig.2).
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Regarding claim 11, Markussen discloses an injection device as recited above, wherein the drive means is a spring (360 – Fig.1a).
Regarding claim 12, Markussen discloses an injection device as recited above, wherein the spring is a compression spring (“compression spring” – Fig.1a).
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Markussen in view of Wotton et al. (US 20130303985 A1, herein, Wotton).
Regarding claim 4, Markussen discloses an injection device as recited above, comprising a housing (200 – Fig.1c) but Markussen does not expressly disclose wherein the housing comprises a distal length with a reduced inner diameter to a proximal portion of the housing, the reduced inner diameter maintaining the compressed configuration of the intermediate driver.
Wotton discloses an injection device, wherein a housing (14, 64 – Fig.6B) comprises a distal length with a reduced inner diameter (See annotated Fig.6B below) to a proximal portion of the housing (64 - Fig.6B), the reduced inner diameter maintaining a compressed configuration of an intermediate member (54, 56 – Fig.6B)(“to retain the trigger protrusions in the blocking association in the recess to hold ram in the proximal position until firing is actuated” – Para [0062]).
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It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the housing of Markussen to comprise a distal length with a reduced inner diameter to a proximal portion of the housing as taught by Wotton Since Wotton teaches that the reduced inner diameter retains the trigger protrusions to hold the piston rod in place before being actuated (Wotton, Para [0062]), this is beneficial to Markussen since this maintains the spring in the compressed configuration avoiding unwanted lateral movement or shifting of the spring.
Regarding claim 5, Markussen discloses an injection device as recited above, comprising a housing with a diameter (200 – Fig.1c) but Markussen does not expressly disclose wherein a reduced diameter is provided by one or more support ribs or an increased thickness of the wall of the housing.
Wotton discloses an injection device, wherein a housing (14, 64 – Fig.6B) comprises a reduced diameter provided by an increased thickness of the wall of the housing (as shown at 64 – Fig.6B).
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the housing of Markussen to comprise a reduced diameter provided by an increased thickness of the wall of the housing as taught by Markussen since Wotton teaches that the increased thickness of the wall retains the trigger protrusions to hold the piston rod in place before being actuated (Wotton, Para [0062]), this is beneficial to Markussen since this maintains the spring in the compressed configuration avoiding unwanted lateral movement or shifting of the spring.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 Marissa Taylor whose telephone number is (571)272-3542. The examiner can normally be reached Monday-Thursday 6:30am-3:30pm EST.
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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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/MARISSA TAYLOR/Examiner, Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783
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