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 .
This action is in response to Applicant’s amendment filed on June 11, 2025.
Claims 2-12 are withdrawn.
Claims 13-21 are being examined in this office action.
Election/Restrictions
Applicant’s election without traverse of 13-21 in the reply filed on June 11, 2025 is acknowledged.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “slidable stop” of claim 15, the “plunger interlocking interface” of claim 16, and the “helical screw interface” of claim 17 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 15-17 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 15, the term “slidable stop” appears in claim 15 but does not appear anywhere in the specification as a defined term, and is not associated with any reference numeral in the drawings. Accordingly, the scope of claim 15 cannot be determined with reasonable certainty.
Regarding claim 16, the term “plunger interlocking interface” appears in claim 16 and in paragraph [0009] of the specification, but is not used as a label in the detailed description. It is not associated with any reference numeral in the drawings. Accordingly, the scope of claim 16 cannot be determined with reasonable certainty.
Regarding claim 17, the term “helical screw interface” appears in claim 17 and in paragraph [0009] of the specification, but is not used as a label in the detailed description. It is not associated with any reference numeral in the drawings. Accordingly, the scope of claim 17 cannot be determined with reasonable certainty.
Notwithstanding these rejections under 35 U.S.C. 112(b), and solely for the purposes of examination, the following prior art rejections are made based on the broadest reasonable interpretations of:
slidable stop (as sealing element 140).
plunger interlocking interface (as the coupling between sealing element 140 and plunger portions 132 and 134).
helical screw interface (as a threaded coupling between plunger portions 132 and 134).
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.
Claims 13-16, 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Mazur (US Patent No. 5401246), hereinafter, Mazur, in view of Dasbach (EP Patent No. 2491971), hereinafter, Dasbach, in further view of Huber (US Patent No. 2748769), hereinafter, Huber.
Regarding claim 13, Mazur discloses an injection subassembly (Mazur; retractable syringe 10 including a hollow syringe barrel 12, a needle 22, a needle holder assembly 18, a shaft 14 and piston 24 that dispenses liquids in figs. 1), comprising: a needle guide bushing (Mazur; needle holder assembly 18 in fig. 1), comprising a proximal end (Mazur; region of needle holder assembly 18 facing radial passage 52 in fig. 1) a distal end (Mazur; region of needle holder assembly 18 facing needle 22 and forward end 15 in fig. 1) and a lumen (passage 72 and radial passage 52 in figs. 1, 5) therebetween; and
a needle (Mazur; needle 22 in fig. 1) within the needle guide bushing (Mazur; needle holder assembly 18 in fig. 1), comprising a proximal end (Mazur; proximal region of needle 22 positioned within holder 18 and in fluid communication with chamber volume 46 via radial passage 52 and axial passage 72 in figs. 1, 5), and longitudinal lumen between the proximal end and the distal end (Mazur; needle 22 is tubular and longitudinally positioned to connect proximal and distal ends needle holder assembly; volume 46 through radial passage 52 and passage 72 and out of needle 22).
Mazur does not, however, disclose:
a needle catch interface in the needle guide bushing;
a needle slidably located within the needle guide bushing;
a bushing catch interface complimentary to the needle catch interface;
a needle with a beveled distal end with a transverse opening.
Dasbach teaches a needle catch interface (Dasbach; retaining member 13 in figs. 2-3; col. 3, line 46 – col. 4, line 31);
Dasbach teaches a needle slidably located (Dasbach; needle 3 slidable with needle guide 11 in figs. 2-3; col. 3, line 52 – col. 4, line 4);
Dasbach teaches a bushing catch interface (Dasbach; retaining element 12 in figs. 2-3; col. 3, line 46 – col. 4, line 31) complementary to the needle catch interface (Dasbach; retaining member 13 in figs. 2-3; col. 3, line 46 – col. 4, line 31);
Huber teaches a beveled (Huber; beveled end surface 13 in figs. 1-2, 5) distal end (Huber; the lower distal end of needle 8 in fig. 14) with a transverse opening (Huber; port or passage 16 in figs. 1-6; passage 16 is located adjacent to the beveled distal end)
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 retractable syringe of Mazur to incorporate the sliding needle and catch interface configuration, as taught by Dasbach, so that the needle is slidably located within the needle guide bushing and includes complementary needle-side and bushing-side catch interfaces. This modification would secure the slidable needle within the guide with the predictable benefit of reliably retaining the needle in its extended position.
It would have been further obvious to modify the distal end of Mazur’s tubular needle to include a beveled distal end with a transverse opening in the sidewall adjacent to the beveled edge, as taught by Huber, in order to facilitate tissue penetration with reduced insertion force and provide an access path into the needle lumen near the tip to receive a pull wire or cap through a transverse opening.
Regarding claim 14, modified Mazur discloses the injection subassembly of claim 13, further comprising: a medicament cartridge (Mazur; barrel 12 in figs. 1, 5, 8-10), comprising a proximal end (Mazur; region near rearward open end 17 and piston 24 in figs.1, 5), a distal end (Mazur; region near forward end 15 and needle holder 18 in figs. 1, 5, 8-10) and an internal cavity therebetween (Mazur; chamber volume 46 in figs. 1, 5, 8-10), and wherein the needle guide bushing resides within the internal cavity of the medicament cartridge (Mazur; needle holder 18 resides in distal region of internal cavity of barrel 12 and chamber volume 46 in figs. 1, 5, 8-10) and the distal end of the needle is located distal to the distal end of the medicament cartridge (Mazur; needle 22 extends through needle holder 18 and forward end 15 of barrel 12 such that the tip is outside barrel 12 in figs. 1, 5, 8-10).
Regarding claim 15, modified Mazur discloses the injection subassembly of claim 14, further comprising a slidable stop (Mazur; piston 24 in figs. 5-6; col. 6, lines 16-20) within the internal cavity (Mazur; chamber volume 46 in figs. 1, 5, 8-10).
Regarding claim 16, modified Mazur discloses the injection subassembly of claim 15, wherein the slidable stop (Mazur; piston 24 in figs. 5-6; col. 6, lines 16-20) comprises a proximal surface (Mazur; region of piston 24 facing shaft 14 and open end 17 in fig. 5; col. 6, lines 16-20, 49-51) accessible from the proximal end of the medicament cartridge (Mazur; barrel 12 enclosed region near rearward open end 17 and piston 24 in figs.1, 5), the proximal surface comprising a plunger interlocking interface (Mazur; piston shaft 14 connected to lath members 37 and 38 in figs. 4-5; col. 6, lines 49-51).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over modified Mazur as applied to claim 13-16 above, and further in view of McCann (EP Patent No. 3226941), hereinafter, McCann.
Regarding claim 17, modified Mazur discloses the injection subassembly of claim 16 including a plunger interface (Mazur; piston shaft 14 connected to lath members 37 and 38 in figs. 4-5; col. 6, lines 49-51), but fails to teach wherein the plunger interface is a helical screw interface.
McCann teaches a helical screw interface (McCann; threaded portion 4 at one end of plunger rod assembly 2 in figs. 1-5; threaded portion 4 interfaces with piston or stopper; col. 4, lines 40-45).
It would have been obvious to one of ordinary skill in the art before the effective date of the claimed invention to modify the plunger interface of Mazur to employ a helical screw interface, as taught by McCann, for coupling the plunger to a stopper in order to provide secure interlocking engagement with predictable results.
Regarding claim 18, modified Mazur discloses the injection subassembly of claim 13, further comprising a syringe connector (Mazur; forward open end 15 of barrel 12 with lip 58 and internal circular hook portion 78 all connected to needle holder 18 with cam surface 82 and groove 68 in figs. 5, 8; col. 8, lines 30-69).
Regarding claim 19, modified Mazur discloses the injection subassembly of claim 18, wherein the syringe connector (Mazur; forward open end 15 of barrel 12 with lip 58 and internal circular hook portion 78 all connected to needle holder 18 with cam surface 82 and groove 68 in figs. 5, 8; col. 8, lines 30-69) comprises a proximal friction interfit interface (Mazur; barrel lip 58 with hook portion 78 and cam surface 82 with groove 68 engage using a snap fit; col. 8, lines 30-69).
Claims 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over modified Mazur as applied to claim 13-19 above, and further in view of Whitney (US Patent No. 4220151), hereinafter, Whitney.
Regarding claim 20, modified Mazur discloses the injection subassembly of claim 18, wherein the syringe connector (Mazur; forward open end 15 of barrel 12 with lip 58 and internal circular hook portion 78 all connected to needle holder 18 with cam surface 82 and groove 68 in figs. 5, 8; col. 8, lines 30-69) is a Luer connector (Whitney; Luer tapered connector 28 with Luer lock threads 52 of Luer lock collar 30 engaged with threads on interior wall indicated at 54 in fig. 2; col.2, line 65 – col. 3, line 2).
Regarding claim 21, modified Mazur discloses the injection subassembly of claim 20, wherein the syringe connector (Mazur; forward open end 15 of barrel 12 with lip 58 and internal circular hook portion 78 all connected to needle holder 18 with cam surface 82 and groove 68 in figs. 5, 8; col. 8, lines 30-69) and the needle guide bushing (Whitney; needle hub 32 carrying a hypodermic needle cannula 34 and associated Luer connector 28 and lock collar 30 in fig. 2),) are integrally formed (Whitney; fig. 2; col. 2, lines 27-34; col.2, line 65 – col. 3, line 2).
Conclusion
THIS ACTION IS MADE FINAL. 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 ZACHARIAH K WHITROCK whose telephone number is (571)272-3534. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm.
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.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ZACHARIAH K WHITROCK/Patent Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783