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 .
Election/Restrictions
Applicant’s election without traverse of Species B, Subspecies I, Species 4 in the reply filed on 4/24/2026 is acknowledged.
Claims 6-7 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 4/24/2026.
Claim Objections
Claim 12 is objected to because of the following informalities: “the fixed and movable members” should be “the fixed member and the movable member”. Appropriate correction is required.
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.
Claims 12-16 are 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 12, the limitation “substantially overlap” renders the claim indefinite because its unclear how much overlap is required to infringe on the claims. The specification provides nominal recitation of the term without additional explanation. Additionally, the limitation “minimal overlap” renders the claim indefinite because its unclear how little overlap is required to infringe on the claim.
Regarding claim 14, the limitation “substantially aligned” renders the claim indefinite because its unclear how aligned the sleeve must be to anticipate the claim scope.
Regarding claim 16, the limitation “at substantially the same time” render the claims indefinite because its unclear how substantially at the same time the device must be configured to contact the skin as the distal tip. The specification merely nominally recites the term without meaningful explanation.
Claims dependent thereon are rejected for the same reasons.
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.
Claim(s) 1, 3-5, 8, 10, 12, 14-17, 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jakob US 2015/0032061.
Regarding claim 1, Jakob discloses a system for injection, comprising: a syringe body 2 having proximal and distal ends, the proximal end is the end in which the plunger not shown is inserted, the distal end is the end on which the needle is attached, and defining a syringe interior 3; a stopper member disposed in the syringe interior; a plunger member coupled to the stopper member and configured to be manipulated to insert the stopper member distally in the syringe interior relative to the syringe body, see para. [0046] stating that the syringe container is designed to accommodate a syringe plunger not shown in the drawing, where the plunger inherently requires a stopper member to push the medication through the syringe, the plunger inherently operates by pressing toward the distal end; a needle hub assembly coupled to the syringe body at the distal end thereof and comprising a needle hub, the needle 4 is connected to the syringe body by element 5, 7, and a needle 4 coupled to the needle hub; a needle shield 5 removably coupled to the needle hub over the needle; and a telescoping sleeve 10, 11 coupled to the distal end of the syringe body at least partially over the needle shield, see fig. 6 for example.
Regarding claim 3, Jakob discloses the telescoping sleeve comprises fixed and movable members configured to telescope relative to each other along a longitudinal axis of the telescoping sleeve. Referring to figure 29 for example, the fixed member is 12 and the movable members are 11, 10, and are shown in the deployed configuration in fig. 29.
Regarding claim 4, Jakob discloses the movable member is disposed at least partially radially outside the fixed member. See fig. 29, element 11 is radially outside of 12, element 10 is radially outside of elements 11, 12.
Regarding claim 5, Jakob discloses the movable member defines an annular space, and wherein the fixed member is at least partially disposed in the annular space. See fig. 29, the annular space is the space inside elements 11 and 10, showing an annular telescoping elements 10-12, the collapsed configuration is shown in fig. 19.
Regarding claim 8, Jakob discloses the movable member defines a plurality of inwardly extending members configured to interfere with a proximal end of the needle shield when the needle shield is coupled to the needle hub. Jakob teaches a ring shaped cover, shown in fig. 12 for example having a plurality of radially extending members, the members that connect the element 34 to the annular hole, the needle shield 5 is at least partially covered and thus is interfered with by the plurality of radially extending members.
Regarding claim 10, Jakob discloses the fixed member defines an outwardly extending flange 57 at a distal end thereof, wherein the movable member defines an inwardly extending flange 52 at a proximal end thereof, and wherein the outwardly extending flange and the inwardly extending flange are configured to interfere with each other to limit distal movement of the movable member relative to the fixed member, the interference fit is shown in fig. 26.
Regarding claim 12, Jakob discloses the telescoping sleeve has a retracted configuration, see fig. 19, 28, and an extended configuration, see fig. 20, 27, wherein the fixed and movable members substantially overlap each other when the telescoping sleeve is in the retracted configuration, see fig. 28, element 10 covers elements 11, 12, element 11 covers element 12, and wherein the movable member is moved distally relative to the fixed member with minimal overlap between the fixed and movable members when the telescoping sleeve is in the extended configuration, see fig. 26 showing the extended configuration with overlap only at their proximal ends.
Regarding claim 14, Jakob discloses a distal end of the movable member is substantially aligned with a distal tip of the needle along a longitudinal axis of the system when the telescoping sleeve is in the extended configuration. See figure 13 in the fully collapsed configuration and figure 14 in the fully extended configuration such that the distal tip of 34 covers the needle safety cap 5 and thus interpreted as substantially aligned with the distal tip of the needle. See also figs. 19-20.
Regarding claim 15, Jakob discloses a distal end of the movable member prevents a distal tip of the needle from being seen from proximal of the movable member when the telescoping sleeve is in the extended configuration. Referring to fig. 14, Jakob shows a distal tip of the needle is not seen in the full extended position and is covered by the distal end of the movable member 10. See also the configuration of fig. 20.
Regarding claim 16, Jakob discloses a distal end of the movable member is configured to contact a patient’s skin at substantially the same time as a distal tip of the needle during an injection using the system when the telescoping sleeve is in the extended configuration. Jakob discloses an apparatus, the movable members 10, 11 are extendable during an injection such that the distal end of 10 can contact a patient’s skin at the same time as the tip of the needle when in an extended position.
Regarding claim 17, Jakob discloses a retaining clip configured to secure the telescoping sleeve to the needle hub. The clip 28 secures and attaches the telescoping sleeve to the syringe body and thus to the needle hub.
Regarding claim 20, Jakob discloses the movable member defines a substantially flat distally facing surface. See element 42.
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.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jakob in view of Chiu US 6,761,705.
Regarding claim 2, Jakob discloses all elements except the needle hub defines a circumferential groove, wherein the needle shield comprise an elastic material configured to interfere with the circumferential groove in the needle hub to resist removal of the needle shield from the needle hub. Jakob does teach that the components of the injection device 1 are made of plastic, i.e. an elastic material. See para. [0047]. Jakob shows a needle guard 5 that appears to be breakaway as shown in fig. 6.
Chiu teaches a needle guard 5 that engages with a needle hub that defines a circumferential groove 54 to resist removal of the needle shield of the needle hub. See col. 2, lines 53-57.
It would have been obvious to an ordinary skilled worker to substitute the breakaway needle shield of Jakob with the circumferential groove configuration of Chiu as part of an obvious substitution of one known needle guard attachment for another to provide a predictable result of attaching the needle guard to protect the needle. See KSR; MPEP 2141 III A.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jakob in view of Mosebach US 2016/0144129.
Regarding claim 11, Jakob discloses all elements except for the movable member defines an outwardly sloping surface configured to facilitate application of a distally directed force to the movable member of the telescoping sleeve.
Referring to fig. 1A, Mosebach teaches a cap 11 that comprises grip features 11.5 for facilitating removal of the cap. See para. [0047]. The grip is an outwardly sloping surface configured to facilitate application of a distally directed force to the movable member of the telescoping sleeve.
It would have been obvious to an ordinary skilled worker to provide the grip feature taught by Mosebach, on the movable member of Jakob, in order to facilitate removal of the cap. Id.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jakob in view of Alchas US 2005/0203459.
Regarding claim 13, Jakob discloses all elements but does not disclose the telescoping sleeve also has a fully retracted configuration, wherein the fixed member defines a side opening, wherein the movable member comprises a latch configured to enter the opening when the telescoping sleeve is in the fully retracted configuration, thereby preventing the movable member from moving distally relative to the fixed member. Jakob does teach the telescoping sleeve has a fully retracted configuration, see for example fig. 13.
Alchas teaches a side opening 46 in a fixed member 26, the movable member comprises a latch 44 configured to enter the opening as shown in fig. 4a, the latch in the opening prevents the sheath 34 from moving forward/distally. See para. [0034].
It would have been obvious to an ordinary skilled worker to provide a latch and opening in the movable and fixed members of Jakob, as taught by Alchas, in order to provide a means to hold the sheath in the retracted position. Id.
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jakob in view of Yang US 20030216695.
Regarding claim 21, Jakob discloses all elements a safe rejection system configured to retract the needle at least partially within the syringe body after an injection with the system is completed such that a distal end of the needle is disposed within the needle hub or the syringe body.
Yang teaches a needle and syringe where the needle is configured to retract into the body of the syringe in order to protect patients and staff from needle sticks. See para. [0106].
It would have been obvious to an ordinary skilled worker to provide a mechanism to retract the needle into the syringe body after injection of the apparatus of Jakob, as taught by Yang, such that the distal end of the needle is disposed within the needle hub or syringe body, in order to protect patients and staff from needle sticks. Id.
Allowable Subject Matter
Claims 9, 18-19, 22-29 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.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 9, the prior art does not teach or fairly suggest the plurality of inwardly extending members are configured to exert a distally directed force from the movable member to the proximal end of the needle shield when the needle shield is coupled to the needle hub.
Regarding claim 18, the prior art does not teach or fairly suggest the movable member defines a plurality of distally extending members configured to removably retain the needle shield away from a distal end of the needle after the needle shield is removed from the needle hub.
Claims dependent thereon are objected to for the same reasons.
Regarding claim 22, the prior art does not teach or fairly suggest the movable member defines a pair of inwardly extending latches configured to interfere with a proximal end of the needle shield when the needle shield is coupled to the needle hub.
Attached herein are the relevant references that comprise a needle shield in combination with a telescoping sleeve. The Examiner notes the counter part offices opinions which indicate lack of inventive step (obviousness) or novelty. The references cited do not appear to show the connection between the needle caps and the telescoping sleeves. Some aspects of the invention are discussed such as inwardly extending members engaging the needle sheath 189 at a proximal end thereof. However, the component engaging the element does not appear to be a telescoping sleeve but rather a depth adjuster housing.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GERALD LUTHER SUNG whose telephone number is (571)270-3765. The examiner can normally be reached 9-5 PST.
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/GERALD L SUNG/Primary Examiner, Art Unit 3741
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