DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Status of Claims
The amendments filed 12/19/2025 have been entered.
Claims 1-15 and 22 were previously cancelled.
Claims 16-21 and 23-33 remain pending in the application.
Applicant’s amendments to the Claims have overcome each and every 112(b) rejection previously set forth in the Final Office Action mailed 09/23/2025.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 December 19, 2025 has been entered.
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 29 is 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.
Regarding claim 29, the phrase "essentially" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim Rejections - 35 USC § 102
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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 16, 17, 19-21, 25, 30, and 33 are rejected under pre-AIA 35 U.S.C. 102b as being anticipated by Alchas et al. (U.S. Patent Pub. 20050033230), hereinafter Alchas.
Regarding claim 16, Alchas discloses a safety device for a pre-filled syringe with an injection needle, the safety device comprising
a support body (sleeve 36, see FIGS. 5-7) adapted to mount the pre-filled syringe (prefillable container 12);
a needle shield (limiter 22) slidably arranged with respect to the support body; and
a retention and locking mechanism (catch 51 and slot 53, see FIGS. 5-7) configured to releasably retain the needle shield with respect to the support body in a first advanced position (see FIGS. 5 AND 6) and lock the needle shield with respect to the support body in a second advanced position (see FIG. 7),
wherein the retention and locking mechanism is arranged at a distal end of the safety device (see FIG. 7), and the retention and locking mechanism comprises at least one deflectable resilient arm (arm of limiter 22 connected to catch 51; the Examiner notes arm of limiter 22 is biased, and therefore resilient, see [0031]),
wherein the at least one deflectable resilient arm (arm of limiter 22 connected to catch 51) latches to a catching recess formed in a distal end of the support body to releasably retain the needle shield in the first advanced position (While Alchas does not expressly state a recess, Alchas shows in FIG. 5 that limiter 22 is retained with respect to sleeve 36 via the corner created by the skin facing side of the sleeve perpendicular top the central axis of the device and the longitudinal side of the sleeve that runs parallel to the central axis of the device. A corner can be considered a recess as it’s defined as a small space created by the angle of two walls nest to one another. The Examiner is of the position this along with FIG. 5 is sufficient disclosure to teach the at least one deflectable resilient arm latches to a catching recess formed in a distal end of the support body to releasably retain the needle shield in the first advanced position.),
wherein the retention and locking mechanism comprises a catch (catch 51) formed on an outer surface of the support body (sleeve 36), wherein the catch is different from the deflectable arm, and
wherein the catch latches to a second catching projection (slot 53) formed in the needle shield to lock the needle shield in the second advanced position (“catch 51 is biased to engage the slot 53”, [0033]; see FIG. 7).
Regarding claim 17, Alchas teaches the claimed invention as discussed above concerning the rejection of claim 16, and Alchas further discloses wherein the needle shield comprises an annular flange (skin engaging limiter 24) adapted to rest on skin of a patient receiving an injection (see FIG. 5).
Regarding claim 19, Alchas teaches the claimed invention as discussed above concerning the rejection of claim 16, and Alchas further discloses wherein the needle shield is movable from the first advanced position to the retracted position and from the retracted position to the second advanced position (see paragraph [0027]), wherein the needle shield in the first advanced position protrudes from the support body in a distal direction by a first distance and the needle shield in the second advanced position protrudes from the support body in the distal direction by a second distance, wherein the first distance is smaller than the second distance (the Examiner notes difference in distance seen by catch 47 in FIGS. 6 and 7).
Regarding claim 20, Alchas teaches the claimed invention as discussed above concerning the rejection of claim 16, and Alchas further discloses wherein the retaining and locking mechanism is arranged to releasably retain the needle shield in the first advanced position in a manner such that the needle shield is releasable by a linear translatory movement of the needle shield with respect to the support body parallel to a central axis of the safety device (see paragraph [0032]).
Regarding claim 21, Alchas teaches the claimed invention as discussed above concerning the rejection of claim 16, and Alchas further discloses wherein the at least one deflectable resilient arm is part of the needle shield (catch 51 is disposed upon a side of the limiter 22, paragraph [0033]) and is arranged within a portion of the needle shield so as to shield the at least one deflectable resilient arm from being exposed to an exterior (see FIGS. 5-7).
Regarding claim 25, Alchas teaches the claimed invention as discussed above concerning the rejection of claim 16, and Alchas further discloses wherein the at least one deflectable resilient arm is stressed and inwardly deflected relative to a central axis of the safety device (the Examiner notes arm of limiter 22 connected to catch 51 is deflected outward from sleeve 36 in first position 28) when the needle shield is in the retracted position and when the needle shield in the second advanced position (See FIG. 6).
Regarding claim 30, Alchas teaches the claimed invention as discussed above concerning the rejection of claim 16, and Alchas further discloses wherein the needle shield is biased with respect to the support body in a distal direction by a spring (limiter 22 is biased outwardly of the sleeve 36 by a spring means 38, paragraph [0029]).
Regarding claim 33, Alchas discloses an injection device comprising:
a pre-filled syringe (prefillable container 12), and
a safety device comprising:
a support body (sleeve 36, see FIGS. 5-7) adapted to mount the pre-filled syringe;
a needle shield (limiter 22) slidably arranged with respect to the support body; and
a retention and locking mechanism (catch 51 and slot 53, see FIGS. 5-7) configured to releasably retain the needle shield with respect to the support body in a first advanced position (see FIGS. 5 AND 6) and lock the needle shield with respect to the support body in a second advanced position (see FIG. 7),
wherein the retention and locking mechanism is arranged at a distal end of the safety device (see FIG. 7), and the retention and locking mechanism comprises at least one deflectable resilient arm (arm of limiter 22 connected to catch 51; the Examiner notes catch 51 is biased, and therefore resilient, see [0031]),
wherein the at least one deflectable resilient arm (arm of limiter 22 connected to catch 51) latches to a catching recess formed in a distal end of the support body to releasably retain the needle shield in the first advanced position (While Alchas does not expressly state a recess, Alchas shows in FIG. 5 that limiter 22 is retained with respect to sleeve 36 via the corner created by the skin facing side of the sleeve perpendicular top the central axis of the device and the longitudinal side of the sleeve that runs parallel to the central axis of the device. A corner can be considered a recess as it’s defined as a small space created by the angle of two walls nest to one another. The Examiner is of the position this along with FIG. 5 is sufficient disclosure to teach the at least one deflectable resilient arm latches to a catching recess formed in a distal end of the support body to releasably retain the needle shield in the first advanced position),
wherein the retention and locking mechanism comprises a catch (catch 51) formed on an outer surface of the support body (sleeve 36), wherein the catch is different from the deflectable arm, and
wherein the catch latches to a second catching projection (slot 53) formed in the needle shield to lock the needle shield in the second advanced position (“catch 51 is biased to engage the slot 53”, [0033]; see FIG. 7).
Claim Rejections - 35 USC § 103
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.
Claims 18, 23-24, 31, and 32 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Alchas et al. (U.S. Patent Pub20050033230), hereinafter Alchas.
Regarding claim 18, Alchas teaches the claimed invention as discussed above concerning the rejection of claim 16, however, Alchas does not expressly state wherein the support body, the needle shield and/or an outer body is at least partially made from a transparent plastics material.
It would be obvious to one of ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the invention disclosed by Alchas so that at least one of the support body, needle shield or outer body is made from a transparent plastic material, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin 125 USPQ 416
Regarding claim 23, Alchas teaches the claimed invention as discussed above concerning the rejection of claim 16, and Alchas further discloses wherein the at least one deflectable resilient arm is pre-tensioned and deflected in a direction relative to a central axis of the safety device (the Examiner notes arm of limiter 22 connected to catch 51 is deflected inward from sleeve 36 in first position 28) when latching to the catching recess to releasably retain the needle shield in the first advanced position (see FIG. 7). However, Alchas does not teach that the direction is deflected in an outward direction.
It would have been an obvious matter of design choice to have the arm deflect outward since applicant has not disclosed that this difference solves any stated problem or is for any particular purpose and it appears that the invention would perform equally well with an inward or neutral deflection.
Further, it would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to have the arm deflect outward instead of inward or neutral , since it has been held that a mere reversal of the essential working parts of a device involves only routine skill in the art. In re Einstein, 8 USPQ 16 .
Regarding claim 24, Alchas teaches the claimed invention as discussed above concerning the rejection of claim 23, and Alchas further discloses wherein the at least one pre-tensioned deflectable resilient arm rebounds due to a material memory effect when the needle shield is released from being retained in the first advanced position (the Examiner notes arm of limiter 22 connected to catch 51 unbends to fit into slot 53 in embodiment seen in FIG. 7).
Regarding claim 31, Alchas teaches the claimed invention as discussed above concerning the rejection of claim 30, however, Alchas does not expressly state wherein the spring (spring 38) comprises a spring arm (catch 67) made from a plastic material.
It would be obvious to one of ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the invention disclosed by Alchas so that a spring arm is made of plastic material, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin 125 USPQ 416
Regarding claim 32, Alchas teaches the claimed invention as discussed above concerning the rejection of claim 31, and Alchas further teaches wherein the spring arm (catch 67) is attached to the needle shield (alternate limiter 66) and engages a first ramp (see circled ramp of on outer surface of limiter 66 in Examiner annotated FIG. 12 below) formed on an outer surface of the support body.
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Claims 26 and 27 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Alchas et al. (U.S. Patent Pub. 20050033230), hereinafter Alchas, further in view of Giambattista et al. (U.S. Patent Pub. 20040193110), hereinafter Giambattista.
Regarding claim 26, Alchas teaches the claimed invention as discussed above concerning the rejection of claim 25, however, Alchas does not expressly state wherein the at least one deflectable resilient arm comprises at least two deflectable resilient arms, and the at least two deflectable resilient arms are inwardly deflected relative to a central axis of the safety device and locked to each other by at least one interlocking element of the retention and locking mechanism when the needle shield is in the retracted position and when the needle shield in the second advanced position.
Giambattista teaches a pen needle and safety shield system (background [0001]) wherein the at least one deflectable resilient arm comprises at least two deflectable resilient arms (hooked shape fingers 52, see FIG. 2), and the at least two deflectable resilient arms are inwardly deflected relative to a central axis of the safety device and locked to each other by at least one interlocking element of the retaining and locking mechanism (fingers 52 are supported on a U-shaped portion 54 which further improves the resiliency of the fingers as they flex inwardly and spring outwardly, [0025]) when the needle shield is in the retracted position and when the needle shield in the second advanced position (see [0030-0031]).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the arms of Alchas to be at least two deflectable resilient arms, and the at least two deflectable resilient arms are inwardly deflected wherein the at least two deflectable resilient arms are locked to each other by at least one interlocking element of the retaining and locking mechanism when the needle shield is in the retracted position and when the needle shield in the second advanced position. Doing so would locks the safety shield in the desired position relative to the needle during and after injection, as taught by Giambattista (see [0030-0031]).
Regarding claim 27, Alchas in view of Giambattista teaches the claimed invention as discussed above concerning the rejection of claim 26, however, Alchas in view of Giambattista does not expressly state wherein the at least one interlocking element comprises at least two interjacent interlocking elements and the at least two deflectable resilient arms are arranged opposite to each other and are locked to each other by the at least two interjacent interlocking elements.
It would be obvious to one of ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the interlocking elements of Giambasttista to comprise at least two interjacent interlocking elements (the Examiner notes it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8) and the at least two deflectable resilient arms are arranged opposite to each other and are locked to each other by the at least two interjacent interlocking elements. Doing so allows for circumferential spacing, as taught by Giambattista (see [0025-0026]).
Allowable Subject Matter
Claim 29 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claims 28 and 29 are 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.
Response to Arguments
Applicant’s arguments, see Remarks, filed 12/19/2025 with respect to the rejection(s) of claim(s) 16, 17, 19-25, 30, and 33 rejected under pre-AIA 35 U.S.C. 102 to Alchas (U.S. Patent Pub. 20050033230) have been fully considered but they are not persuasive.
In regards to the Applicant’s argument that “Alchas does not disclose a catch that is structurally distinct from the deflectable resilient arm as required by amended claim 16.”
This is not persuasive for the following reasons: FIGS. 5 and 6 of Alchas demonstrate the physical separation between catch 51 and the resilient portion of limiter 22 that engages with slot 53. The Examiner is of the position this is sufficient disclosure to teach or suggest that "the catch is different from the deflectable resilient arm" as amended in claims 16 and 33.
In regards to the Applicant’s argument that “Alchas does not teach or suggest that "the catch latches to a projection formed in the needle shield to lock the needle shield in the second advanced position" as recited by amended claim 16.”
This is not persuasive for the following reasons:
Alchas FIG. 7 shows the pointed projection that creates the hook shape seen by the side of limiter 22 that engages with catch 51, demonstrating the catch latching onto projection from the needle shield.
Conclusion
Any inquiry concerning this THIS communication or earlier communications from the examiner should be directed to NELSON ALVARADO whose telephone number is (703) 756-5301. The examiner can normally be reached on M-F 8:30am-5pm. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached on (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is (571)-273-8300. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/Nelson Alvarado/
Junior Examiner , Art Unit 3783
03/16/2026
/CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783