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
Claims 20, 24-29, and 33 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.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 August 3, 2026.
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 17 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. The claim sets forth “wherein the c-clip extends more than half of the way around the circumference of relative to the longitudinal axis, and preferably more than 270 degrees around the circumference of relative to the longitudinal axis.” Firstly, it is unclear which circumference is being used as the comparison for the c-clip. It is assumed that the c-clip extends more than half of the way around the circumference of the syringe holder. The scope of the extension is unclear from the claim language. It is not obvious if a range of 180-359 degrees is being claimed. The use of the term “preferably more” renders the scope indefinite. If a specific range of circumference is to be claimed it should be explicitly disclosed. If the claim intends to limit the scope to angles greater than 270 degrees, then that should be clearly disclosed as well. For the purposes of examination, the claim will be considered to only require the c-clip to extend more than halfway around the circumference of the body defining the syringe holder portion.
Claim Rejections - 35 USC § 102
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) 16, 18, 21-23, and 31 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Daniel (2019/0060579).
Regarding claim 16, Daniel discloses a syringe carrier (10) for a syringe (14) with a flange (50; Figure 4), the syringe carrier comprising a tubular housing (Figure 1) extending along a longitudinal axis from a proximal end to a distal end and a syringe holder (e.g., upper body of 12 and holding element 28 with flange 24; it is noted that the instant application defines the “distal end” as the end adjacent the syringe flange or the end further from the patient in a use orientation) attached to the distal end of the tubular housing (Figures 1 and 4), wherein the syringe holder is configured to hold the flange (50; ¶ [0035]) of the syringe, and wherein the syringe holder comprises a c-clip (see for example Figures 3 and 7; each side of holding element 28 may constitute a c-clip as claimed).
Regarding claim 18, Daniel further discloses wherein the c-clip is flexible to allow the diameter of the c-clip to expand to allow the flange of the syringe to pass the c-clip during medicament delivery device assembly (¶ [0033]).
Regarding claim 21, Daniel further discloses a medicament delivery device comprising the syringe carrier (¶ [0030] discloses the device is intended to be attached to a medical delivery device assembly).
Regarding claim 22, Daniel discloses a method of inserting a syringe (14) into a syringe carrier (10) comprising the steps of: providing a syringe carrier (10) for a syringe (14) with a flange (50; Figure 4), the syringe carrier comprising a tubular housing (Figure 1) extending along a longitudinal axis from a proximal end to a distal end and a syringe holder (e.g., upper body of 12 and holding element 28 with flange 24; it is noted that the instant application defines the “distal end” as the end adjacent the syringe flange or the end further from the patient in a use orientation) attached to the distal end of the tubular housing (Figures 1 and 4), wherein the syringe holder is configured to hold the flange (50; ¶ [0035]) of the syringe, and wherein the syringe holder comprises a c-clip (see for example Figures 3 and 7; each side of holding element 28 may constitute a c-clip as claimed); providing a syringe (14; Figure 4) with a flange (50); and inserting the syringe into the syringe carrier in the direction of the longitudinal axis (Figure 4, ¶¶ [0033]-[0035]).
Regarding claim 23, Daniel further discloses wherein the syringe (14) is inserted into the distal end of the syringe carrier and moved in the proximal direction relative to the syringe carrier until the flange of the syringe engages the syringe holder (¶¶ [0033]-[0035] disclose the syringe being inserted through the top or distal end of the carrier until the flange abuts the holding element 28 whereby the guide elements 32 flex around the flange and hold the syringe to the carrier).
Regarding claim 31, Daniel further discloses an assembly comprising: a syringe (14) having a flange (50; Figure 4) and a syringe carrier (10) for a syringe with a flange (Figure 4), the syringe carrier comprising: a tubular housing (see body of carrier in Figure 1) extending along a longitudinal axis from a proximal end to a distal end and a syringe holder (holding element 28 with flange 24) attached to the distal end (Figure 1; the distal end is the end furthest from the patient end of the device) of the tubular housing, wherein the syringe holder surrounds and is engaged with the flange through a connector (holding element 28 connects to the flange of the syringe via cutouts and guide elements 32; ¶ [0030]).
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.
Claim(s) 17, 19, and 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Daniel in view of Dadachanji (US 2021/0077738).
Regarding claims 17 and 32, Daniel discloses the claimed invention substantially as set forth above for claims 16 and 31, and further teaches that the c-clip expands to allow the flange of the syringe to pass through the c-clip axially during device assembly (¶¶ [0033]-[0035]; as per claim 32), but fails to explicitly disclose that the c-clip extends at least halfway around the circumference relative to the longitudinal axis.
Dadachanji teaches a device for attaching to a flange of a syringe (Figure 1b; the flange 13 is received in areas 23 for retaining the flange therein) and wherein the device comprises a syringe holder (Figure 1b) in the form of a c-clip (the mounting portion 40 is embodied as a c-clip) which extends at least halfway around the circumference of the housing and flange (Figure 1b, it can be clearly seen that the c-clip extends at least halfway around the circumference).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the c-clip portions of the device of Daniel to extend halfway around the circumference of the device, since such a configuration is known from Dadachanji, and is used for securing a greater portion of the syringe flange within the holder assembly. In the modification of Daniel, both c-clip portions would extend halfway around the syringe flange while still providing a small gap therebetween for allowing the holder to deflect radially outwardly during syringe insertion to capture more of the flange within the syringe holder connector.
Regarding claim 19, Daniel discloses the claimed device substantially as set forth above for claim 16, but fails to teach the inwardly extending ribs, spaced longitudinally along the length of the holder for retaining the flange of the syringe.
Dadachanji teaches (Figures 3 and 5b) a holding structure for a portion of a syringe (thumb press 50) which comprises a first rib (34) and a second rib (annular bottom portion 32; Figure 3) which are spaced longitudinally along the length of the holder (Figure 3, they’re axially spaced along the length of the device) so that the syringe element (plunger flange 50) fits between the two ribs (see e.g., Figure 6b; ¶ [0083]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the syringe holder of Daniel to comprise the holding flanges of Dadachanji to provide a means of retaining the syringe flange within the c-clip connector as taught by Dadachanji. The flanges of Dadachanji work in a similar manner to the retaining features on the syringe holder of Daniel in that the locking ribs 34 expand or flex radially outwardly to allow the element to be inserted along the longitudinal axis of the holder and move back into position after the flange moves into the holder to retain the flange between the first rib 34 and the second rib 32. The fact that the retaining features engage the plunger flange rather than the syringe body flange is not considered relevant to the modification since it’s only being cited as a known means for retaining a flange feature of a syringe assembly. Therefore, Dadachanji teaches a known analogous means of retaining an annular feature of an injection device between two sets of ribs for preventing unwanted axial movement of the syringe feature relative to the holder.
Claim(s) 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Daniel in view of Eaton (US 2011/0172602).
Regarding claim 30, Daniel discloses the claimed invention substantially as set forth above for claim 21 and further discloses the syringe carrier as being used with medicament delivery devices (¶ [0030] discloses that the holder is for attachment to a medicament delivery device) but fails to explicitly disclose the device as an autoinjector.
Eaton teaches an injection device (Figure 1) comprising a syringe carrier (22) which engages a flange (16) of a syringe (10) for connection to an autoinjector device (¶ [0046]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the syringe holder assembly of Daniel to be used in an autoinjector device to allow for fully automated injection of the contents of the syringe of Daniel during an injection procedure as taught by Eaton.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUSTIN L ZAMORY whose telephone number is (571)270-1238. The examiner can normally be reached M-F 8:30am-4:30pm ET.
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/JUSTIN L ZAMORY/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
