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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 June 9, 2026 has been entered.
Response to Amendments
Amendments filed June 9, 2026 have been entered.
Claims 2-12 and 15-17 have been canceled.
Claim 13 has been amended and no new claims have been added.
Claims 13, 14, and 18-21 are pending.
Drawings and Specification
The previous objections to the drawings under 37 CFR 1.83(a) and the rejections under 35 U.S.C. 112(b) directed to claims 15-17 are now moot, because claims 15-17 have been canceled. No drawing objections or 112(b) rejections are maintained against the presently pending claims.
Response to Arguments
Applicant's arguments filed June 9, 2026 have been fully considered but they are not persuasive.
Applicant argues that Mazur is configured to withdraw its needle assembly into the syringe after use, whereas Dasbach is configured so that its needle may be pulled out and replaced, and therefore the combination of Mazur and Dasbach would allegedly frustrate the intended purpose of the references. This argument is not persuasive.
The rejection does not rely on Dasbach for reusability of the syringe or replacement of the needle as an overall system objective. Rather, Dasbach is relied upon for teaching a needle slidably located within a guide and having complementary needle-side and bushing-side catch interfaces that selectively engage to retain the needle relative to the guide. A person of ordinary skill in the art would have recognized that such sliding and catch features could be incorporated in the Mazur device as a predictable use of known elements according to their established functions, without changing Mazur’s overall purpose of retracting the needle after use.
Applicant further argues that amended claim 13 recites a needle cover with a needle pull barb, and that such a structure is not disclosed by Mazur or Dasbach and would not be obvious in view of those references. This argument is also not persuasive. Brimhall teaches a needle cover removably connected to the needle hub and disposed over the needle, wherein the cover is operatively connected to the needle hub assembly such that grasping and pulling the cover moves the needle from a retracted position to an extended position. Thus, Brimhall teaches the claimed needle cover having a structure engaged to the needle assembly for pulling the needle, which reads on the claimed “needle pull barb” under the broadest reasonable interpretation.
It would have been obvious to one of ordinary skill in the art to further modify the Mazur/Dasbach/Huber combination to include the needle cover structure taught by Brimhall because Brimhall demonstrates that a cover operatively connected to a needle hub for pulling and extending a needle assembly was known in the art of retractable needle devices. Incorporating such a known cover-pull feature into the combined device would have been a predictable design choice to facilitate controlled extension and handling of the needle assembly.
Accordingly, the rejection of claim 13 under 35 U.S.C. §103 is maintained.
Claims 14 and 18-21 fall with claim 13 because Applicant has not presented separate arguments for patentability of those claims apart from the arguments directed to claim 13.
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.
Claims 13-14 and 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, and further in view of Brimhall (US Patent No. 6,086,563), hereinafter, Brimhall.
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 (Mazur; 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, or
a needle cover with a needle pull barb engaged to the needle.
Dasbach teaches a needle catch interface in the guide bushing (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);
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.
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 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.
Brimhall teaches a needle cover with a needle pull barb engaged to the needle (Brimhall; needle 30 is pulled into the advanced position using the needle cover 50 until the latch mechanism engages the hub 40; col. 6, lines 51-66 and col. 7, lines 21-31).
It would have been further obvious to one of ordinary skill in the art to further modify the Mazur/Dasbach/Huber combination to include the needle cover structure operatively connected to a needle hub for pulling and extending a needle assembly, as taught by Brimhall, in order to facilitate controlled extension and handling of the needle assembly and provide safe conditions for user interaction.
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 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 Mazur in view of Dasbach, Huber, and Brimhall, as applied to claim 13 above, and further in view of Whitney (US Patent No. 4,220,151), hereinafter, Whitney.
Regarding claim 20, modified Mazur discloses the injection subassembly of claim 18 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).
Mazur fails, however, to disclose that the syringe connector is a Luer connector.
Whitney teaches that the syringe connector 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).
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 connector of modified Mazur to be a Luer connector, as taught by Whitney, in order to provide the predictable benefits of secure, leak-resistant, and detachable connection between the injector subassembly and the needle hub.
Regarding claim 21, modified Mazur discloses the injection subassembly of claim 20 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).
Mazur fails, however, to disclose that the syringe connector and the needle guide bushing are integrally formed.
Whitney teaches that the syringe connector 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).
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 connector and needle guide bushing of modified Mazur to be formed as an integral unit, as taught by Whitney, in order to simplify assembly and improve alignment and sealing in syringe systems.
Conclusion
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
Prosecution Insights