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 .
REQUIREMENT FOR UNITY OF INVENTION
Applicant’s election without traverse of Group I, claims 41-46, in the reply filed on February 16, 2026 is acknowledged. Claims 47-60 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Response to Amendment
This office action is responsive to the amendment filed on February 16, 2026. As directed by the amendment: claims 41, 44, 47-48, and 55 have been amended, no claims have been added, no claims have been canceled. Thus claims 41-60 are presently pending in this application, and claims 47-60 remain withdrawn.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on October 6, 2022 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 42 is objected to because of the following informalities: claim 42, line 2 recites “and first diameter”, should read “and a first diameter” for clarity. Appropriate correction is required.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 41-42 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Steel et al. (US 20160000992), hereinafter Steel.
Regarding claim 41, Steel discloses a modular needle connector (Fig. 1, magazine 2) comprising: a circular disk (Fig. 3, generally circular disk shaped needle carrier 7) comprising: a needle aperture (Fig. 3, aperture 18) positioned non-concentrically with a center of the circular disk (Fig. 3, apertures 18 are non-concentrically positioned on carrier 7); and a needle (Fig. 3, needle assembly 8 with needle 8') connected to the circular disk (Fig. 2 and [0045], needle assembly 8 has needle hub 17 which connects to carrier 7) and extending through the needle aperture (Fig. 2 and [0045], needle assembly 8 extends through aperture 18), the needle having a distal end extending from a first side of the circular disk (Fig. 2, distal end of needle 8' extends from a distal side of carrier 7 towards distal aperture 22) and a proximal end extending from a second side of the circular disk (Fig. 2, proximal end of needle 8' extends from a proximal side of carrier 7 towards septum 5); and a connector body (Fig, 2, body of magazine 2, comprising housing 6 and guard 10) comprising: a disk slot (Fig. 2-3, internal space of guard 10) sized to contain the circular disk and positioned at a first end of the connector body (Fig. 2-3, internal space of guard 10 is sized to contain disk 7 and is positioned at first/distal end of magazine 2 body); and an injector housing (Fig. 2, coupling 9 slot of housing 6) positioned at a second end of the connector body engageable with a reusable injector (Fig. 2, coupling 9 slot is positioned at second/proximal end of magazine 2 body and engageable with cartridge holder 3 of a injector device 1), wherein the proximal end of the needle is positioned within the injector housing (Fig. 5- 6, proximal end of needle 8' may be positioned within the coupling 9 slot of housing 6), and wherein the circular disk is rotatable within the connector body (Fig. 9 and [0007], carrier 7 is rotatable relative to the needle guard 10 and housing 6).
Regarding claim 42, Steel discloses the modular needle connector of claim 41, wherein a first height and first diameter of the circular disk is less than a second height and a second diameter of the disk slot such that the circular disk is rotatable within the disk slot when the connector body is disengaged with the reusable injector (Fig. 2, 3, and 9, the height and diameter of carrier 7 are less than the height and diameter, respectively, of the needle guard 10 of magazine 2 body, such that the carrier is rotatable within the internal space of guard 10 when injector 1 is disengaged).
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.
Claims 43-44 are rejected under 35 U.S.C. 103 as being unpatentable over Steel (US 20160000992), in view of Politis et al. (US 20210121642), hereinafter Politis.
Regarding claim 43, Steel discloses the modular needle connector of claim 41.
Steel fails to disclose wherein the connector body further comprises a plurality of flexible wings extending along at least a portion of a length the injector housing. However, Politis discloses wherein the connector body further comprises a plurality of flexible wings extending along at least a portion of a length the injector housing (Fig. 31-32 and [0110], injector coupling housing sidewall 430 is comprised of three flexible sections 432 which extend along at least a portion of the length of sidewall 430).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Steel to incorporate the disclosures of Politis and modify the side wall of the injector coupling housing to comprise a plurality of flexible sections extending along at least a portion of the length of the sidewall. Doing so would allow for a secure and fluid tight attachment of the injection device to the needle connector via pressing the device into the flexible sections for initial attachment then tightening said attachment by twisting the delivery device further into the threads of the needle connector (Politis, [0110]).
Regarding claim 44, Steel, in view of Politis, discloses the modular needle connector of claim 43, as explained above. As noted above, Steel fails to disclose the plurality of flexible wings and is thus silent to wherein an interior surface of the plurality of flexible wings comprises threads engageable with the reusable injector. However, Politis further discloses wherein an interior surface of the plurality of flexible wings comprises threads engageable with the reusable injector (Fig. 31-32 and [0110], interior surfaces of flexible sections 432 comprise threads 436 which engage with delivery device 10).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Steel, in view of Politis, to further incorporate the disclosures of Politis and modify the plurality of flexible sections to comprise threads engageable with the reusable injector. Doing so would allow for a secure and fluid tight attachment of the injection device to the needle connector via pressing the device into the flexible sections for initial attachment then tightening said attachment by twisting the delivery device further into the threads of the needle connector (Politis, [0110]).
Claims 43-44 are rejected under 35 U.S.C. 103 as being unpatentable over Steel (US 20160000992), in view of Wacks (US 5709668).
Regarding claim 45, Steel discloses the modular needle connector of claim 41.
Steel fails to disclose wherein the distal end of the needle comprises a bevel-tip and the proximal end of the needle comprises a non-coring tip. However, Wacks discloses wherein the distal end of the needle comprises a bevel-tip (Fig. 6C, needle 76 distal/point end has a bevel tip) and the proximal end of the needle comprises a non-coring tip (Figs, 6A-E and Col.9: 46-Col 10:7, needle 76 proximal/butt end comprises a non-coring end).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Steel to incorporate the disclosures of Wacks and modify the needle such that the distal end of the needle comprises a bevel-tip and the proximal end of the needle comprises a non-coring tip. Doing so would minimize or eliminate the coring of a rubber or septum when impaled by the internal/proximal needle tip, thus preventing the pierced portion of the rubber/septum from blocking the injection or itself being injected into the patient along with the medication (Wacks, Col.5:1-10; Col.9:24-28).
Regarding claim 46, Steel, in view of Wacks, discloses the modular needle connector of claim 45, as explained above. As noted above, Steel fails to disclose the non-coring tip and is thus silent to wherein the non- coring tip comprises a blunt tip and a side-mounted fluid inlet. However, Wacks further discloses wherein the non-coring tip comprises a blunt tip (Fig. 6A-E, non-coring end of needle 76 comprises blunt ended crimp 98) and a side-mounted fluid inlet (Fig. 6B-E and Col. 9:31-40, non-coring end of needle 76 comprises side port slot(s) 96/100/102, for receiving fluid).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Steel, in view of Wacks, to further incorporate the disclosures of Wacks and modify the non- coring tip to comprise a blunt tip and a side-mounted fluid inlet. Doing so would minimize or eliminate the coring of a rubber or septum when impaled by the internal/proximal needle tip while still providing an opening for the introduction of medication into the needle, thus preventing the pierced portion of the rubber/septum from blocking the injection or itself being injected into the patient along with the medication (Wacks, Col.5:1-10; Col.9:24-28).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH D GRASMEDER whose telephone number is (571)272-0258. The examiner can normally be reached M-F 8 am-5 pm EST.
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/SARAH DYMPNA GRASMEDER/Examiner, Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783