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 .
Information Disclosure Statement
Applicant has provided a copy of the Written Opinion including cited references. However, no IDS has been received and therefore these documents have not been considered.
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, 2 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cheng et al (US 2018/0280628).
Regarding claim 1, Cheng discloses a syringe for administering a medicament dose to a patient, with a hollow body 110 forming a syringe housing and containing a medicament active substance (page 2, para. 0021; fig. 1B), at a distal end of which a hollow needle 126 provided for injection of the medicament active substance is mounted in a bearing sleeve (fig. 1B: distal portion 112 of barrel forms bearing sleeve), and in which a displaceable piston 140 provided at a proximal end with a receiving hole for the hollow needle is arranged (fig. 2A: receiving hole between arms 1341), wherein the displaceable piston is constructed in several parts (fig. 2A: part 140 and part 134) and, in addition to a needle holder 134 having a holding bracket (arms 1341) which carries needle bearing 1342 forming the receiving hole for the hollow needle (figs. 2B, 2C), comprises a piston jacket 140 which is shaped in such a way that, when the needle holder is inserted, it leaves free on both sides of the holding bracket inflow channels into the enclosed end of the hollow needle for the medicament active substance (fig. 1A: inflow channels formed between the arms 134; Fig. 2B: as the hollow needle proximal end enters the receiving hole, the medicament can flow through the inflow channels to the needle).
Regarding claim 2, Cheng discloses a holding bracket 1341 of the needle holder carries the needle bearing 1342 forming the receiving hole and is provided on its inside with a circumferential locking lip which 1344, when the hollow needle is inserted into the needle bearing, engages in a retaining groove 1221 arranged on an outer circumference thereof and fixes the hollow needle in a longitudinal direction (fig. 2D).
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.
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) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cheng in view of Liu (US 5,931,813).
Regarding claim 3, Cheng discloses that the dimensions of the retaining groove and of the locking lip associated with the needle bearing are selected in such a way that, taking into account deformability of the material at an outer circumference of the hollow needle and the material of the needle bearing surrounding it, a holding or breakaway force of the hollow needle thus engaged in the bearing is greater in a longitudinal direction than the corresponding holding or breakaway force of the hollow needle in the bearing sleeve (Fig. 2D: the needle is pulled out of the bearing sleeve by a proximal force that does not dislodge the retaining groove and the locking lip). However, Cheng fails to disclose the hollow needle having a holding groove. Liu teaches a syringe having a retractable needle wherein the needle has holding grooves (between fixing rings 32) which provide a secure holding force for the needle to prevent dislodging and leakage, while not being so strong as to prevent the needle from being pulled into the chamber by the capture element (col. 4, lines 51-52; fig. 4). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the needle of Cheng to include holding grooves as taught by Liu to provide a secure connection of the needle and the syringe barrel in both the proximal and distal direction while preventing leakage of the fluid out of the barrel and allow for retraction of the needle.
Claim(s) 4, 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cheng in view of Russo et al (US 10,195,363).
Regarding claims 4 and 5, Cheng discloses the syringe of claims 1 and 2 as discussed above and further that the needle is retracted into the interior of the hollow barrel and the trigger plate 136 for actuating the syringe is moved in a direction away from the distal end of the syringe (fig. 2E), but fails to disclose a spring triggering the retraction of the needle and displacement of the trigger plate. Russo teaches a syringe having a retractable needle wherein a spring 42 triggers the retraction of the needle into the barrel and additionally displaces the trigger plate in a direction away from the distal end (col. 14, lines 5-9, 22; figs. 3B, 4A). it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the syringe of Cheng to include a spring triggering retraction of the needle into the barrel and displacing the trigger plate away from the distal end as taught by Russo to provide automatic retraction of the needle thereby ensuring that the needle gets fully retracted to prevent accidental sticks thereby increasing safety and ease of use of the device.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cheng in view of Liu as applied to claim 3 above, and further in view of Russo.
Cheng in view of Liu teaches the syringe of claim 3 as discussed above and Cheng further discloses that the needle is retracted into the interior of the hollow barrel and the trigger plate 136 for actuating the syringe is moved in a direction away from the distal end of the syringe (fig. 2E), but fails to disclose a spring triggering the retraction of the needle and displacement of the trigger plate. Russo teaches a syringe having a retractable needle wherein a spring 42 triggers the retraction of the needle into the barrel and additionally displaces the trigger plate in a direction away from the distal end (col. 14, lines 5-9, 22; figs. 3B, 4A). it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the syringe of Cheng to include a spring triggering retraction of the needle into the barrel and displacing the trigger plate away from the distal end as taught by Russo to provide automatic retraction of the needle thereby ensuring that the needle gets fully retracted to prevent accidental sticks thereby increasing safety and ease of use of the device.
Conclusion
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LAURA A. BOUCHELLE
Primary Examiner
Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783