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 .
Drawings
The drawings were received on 03 December 2025. These drawings are accepted.
Specification
The amendments to the specification were received on 03 December 2025. These amendments are accepted.
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) 1, 4, 6-9, 11, 12, 16-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2017/0259004 (“Carr”) in view of WO 96/41649 (“Shemesh”).
Regarding Claim 1, Carr discloses a needle cap (812, 814) for a medical syringe (Par. 20), comprising:
A tubular body (814) having an inner wall surface defining a cap internal cavity therein (see Fig. 17), the inner wall surface further defining an open-ended, female Luer-taper profile (see where 814 fits over 16 – see generally Par. 55, i.e. the taper of the exterior of the hub to which 814 is fitted corresponds to the luer taper of the interior), first cavity portion on a proximal end of the tubular body which is configured to be selectively coupled to a needle hub (16) of a syringe, and the inner wall surface defining an open cap tip (see the opposite end covered by 812) on a distal end of the tubular body;
A needle seal (808 – Par. 96-98) within the cap internal cavity, dividing the cap internal cavity into a second proximal portion (i.e. the area immediately proximal to the seal between the seal and the hub receiving first cavity portion) and a third distal portion (i.e. the area distal to the seal) that are isolated from each other (via the seal when the needle is received therethrough – see Fig. 18), the needle seal defining a through-bore in communication with both of the second proximal portion and the third distal portion of the cap internal cavity (see Fig. 18), the through-bore in unobstructed, direct fluid communication with the open cap tip, and the through-bore having an internal diameter configured for mated sealing engagement with an outer diameter of a syringe needle when the needle is captured therein (see Fig. 18 – Par. 96-98).
Carr discloses the invention substantially as claimed except that the tubular body has a “tapered, frusto-conical outer surface profile on the distal end thereof, which terminates in the open cap tip and is configured to pierce a stopper of a drug vial”. Rather Carr illustrates that the distal end of the tapered body has a constant diameter (Par. 97). While Carr does disclose a “uniform outer diameter” to this portion no criticality as to this particular shape is recited and in alternative embodiments (714 – see Fig. 11) the distal end of the tubular body is provided with a tapered, frusto-conical outer surface profile which terminates in the open cap tip. In the instant case Carr fails to disclose any particular or specific benefit to such a shape other than “the distal end 744 (FIG. 11) thereof may be immersed in an open ampoule for drawing up fluids…” (Par. 94).
However, Shemesh disclosed a related tubular body (10) for a syringe (2) wherein the tubular body comprises a blunted, tapered, frusto-conical outer surface profile (see Fig. 3 – Abstract), which terminates in an open cap tip and is configured to pierce a stopper of a drug vial or septum/plug of a needleless connector (Abstract) without being sharp enough to cause accidental needle sticks (see Pg. 1) with the tapered shape providing a more “universal application” (Pg. 2) with respect to the septa, seals, and plugs found in vials, ampoules, and needless fittings. It would have been obvious for one having ordinary skill in the art at the time the invention was made to configure the shape of the distal end of Carr to comprise a tapered, frusto-conical outer surface profile on the distal end thereof which is configured to pierce a stopper of a drug vial, as disclosed by Shemesh, in order to permit the cannula to access a variety of vials and ampoules with a more universal application by assisting in stopper/seal/septum penetration by virtue of the frusto-conical shape.
Regarding Claim 4, Carr discloses that in some embodiments (See Fig. 9 - Par. 86) the needle seal is integrally formed with the cap, which forms the mated sealing engagement with an outer diameter of a syringe needle when said needle is captured therein. It would have been obvious for one having ordinary skill in the art at the time the invention was made to construct the embodiment of Fig. 18 to comprise an integrally formed seal section, as disclosed in association with the embodiment of Fig. 9, in order to simplify assembly of the device by eliminating a step. Such an integral construction is understood to be obvious and requires only routine and customary skill in the art when only expected and predictable results are obtained, see In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965).
Regarding Claim 6, Carr discloses the tubular body defining a reduced diameter, necked portion intermediate the female Luer-taper profile, first cavity portion and the tapered, frusto-conical distal end thereof, the needle seal oriented distal to said necked portion (see Fig. 17).
Regarding Claim 7, Carr discloses the proximal end of the tubular body defining an outwardly projecting gripping flange (see Fig. 15 and 17).
Regarding Claim 8, Carr discloses the inner wall surface defining the first cavity portion of the cap internal cavity further comprising a female Luer slip connector (see Fig. 15 and 17).
Regarding Claim 9, Carr does describe that the hub (78) may be provided as a “luer-lock” fitting as an alternative to the depicted “luer-slip” (Par. 55). It would have been obvious for one having ordinary skill in the art at the time the invention was made to construct the inner wall surface of the cap of Carr to comprise a luer-lock fitting to engage with a corresponding luer lock fitting on the exterior of the hub (16) of Carr in order to more securely engage the two components together with a known suitable alternative to the illustrated slip connection which is known to the prior art for its usefulness in securing the fitting against accidental disconnection, particularly when higher viscosity fluids are to be expelled.
Regarding Claim 11, Carr discloses a needle shield (812) coupled to the distal end of the tubular body and sealing the open cap tip (see Fig. 17).
Regarding Claim 12, Carr discloses a syringe (not illustrated – see Par. 119) comprising:
A syringe barrel having proximal and distal ends and a syringe cavity therein (not illustrated, but understood in light of the disclosure of Carr - Par. 119; Clm. 10);
A plunger and coupled plunger stopper in the proximal end of the syringe barrel (not illustrated – see Par. 73);
A male Luer connector on the distal end of the syringe barrel, in fluid communication with the syringe cavity (Par. 55);
A Luer needle hub (78) coupled to the male Luer connector, in fluid communication with the syringe cavity;
A hollow syringe needle (36) having a proximal end coupled to the Luer needle hub, in fluid communication with the syringe cavity, and a distal open needle tip (see Fig. 1);
A needle cap (812, 814) for a medical syringe (Par. 20), comprising:
A tubular body (814) having an inner wall surface defining a cap internal cavity therein (see Fig. 17) for capturing the distal open needle tip, the inner wall surface further defining an open-ended, female Luer-taper profile (see where 814 fits over 16 – see generally Par. 55, i.e. the taper of the exterior of the hub to which 814 is fitted corresponds to the luer taper of the interior), first cavity portion on a proximal end of the tubular body which is coupled to the male luer connector of the needle hub (16) of the syringe, and the inner wall surface defining an open cap tip (see the opposite end covered by 812) on a distal end of the tubular body;
A needle seal (808 – Par. 96-98) within the cap internal cavity, dividing the cap internal cavity into a second proximal portion (i.e. the area immediately proximal to the seal between the seal and the hub receiving first cavity portion) and a third distal portion (i.e. the area distal to the seal) that are isolated from each other (via the seal when the needle is received therethrough – see Fig. 18), the needle seal defining a through-bore in communication with both of the second proximal portion and the third distal portion of the cap internal cavity (see Fig. 18), the through-bore in unobstructed, direct fluid communication with the open cap tip, and the through-bore having an internal diameter configured for mated sealing engagement with an outer diameter of a syringe needle when the needle is captured therein (see Fig. 18 – Par. 96-98).
Carr discloses the invention substantially as claimed except that the tubular body has a “tapered, frusto-conical outer surface profile on the distal end thereof, which terminates in the open cap tip and is configured to pierce a stopper of a drug vial”. Rather Carr illustrates that the distal end of the tapered body has a constant diameter (Par. 97). While Carr does disclose a “uniform outer diameter” to this portion no criticality as to this particular shape is recited and in alternative embodiments (714 – see Fig. 11) the distal end of the tubular body is provided with a tapered, frusto-conical outer surface profile which terminates in the open cap tip. In the instant case Carr fails to disclose any particular or specific benefit to such a shape other than “the distal end 744 (FIG. 11) thereof may be immersed in an open ampoule for drawing up fluids…” (Par. 94).
However, Shemesh disclosed a related tubular body (10) for a syringe (2) wherein the tubular body comprises a blunted, tapered, frusto-conical outer surface profile (see Fig. 3 – Abstract), which terminates in an open cap tip and is configured to pierce a stopper of a drug vial or septum/plug of a needleless connector (Abstract) without being sharp enough to cause accidental needle sticks (see Pg. 1) with the tapered shape providing a more “universal application” (Pg. 2) with respect to the septa, seals, and plugs found in vials, ampoules, and needless fittings. It would have been obvious for one having ordinary skill in the art at the time the invention was made to configure the shape of the distal end of Carr to comprise a tapered, frusto-conical outer surface profile on the distal end thereof which is configured to pierce a stopper of a drug vial, as disclosed by Shemesh, in order to permit the cannula to access a variety of vials and ampoules with a more universal application by assisting in stopper/seal/septum penetration by virtue of the frusto-conical shape.
Regarding Claim 16, Carr discloses the tubular body defines a reduced diameter, necked portion intermediate the female Luer-taper profile, first cavity portion and the tapered, frusto-conical distal end thereof, the needle seal oriented distal said necked portion (see Fig. 15 and 17).
Regarding Claim 17, Carr discloses the proximal end of the tubular body defining an outwardly projecting gripping flange (see Fig. 15 and 17).
Regarding Claim 18, Carr discloses the inner wall surface defining the first cavity portion of the cap internal cavity further comprising a female, Luer slip connector, mating with a corresponding male, Luer slip connector of the needle hub (see Fig. 17).
Regarding Claim 19, Carr does describe that the hub (78) may be provided as a “luer-lock” fitting as an alternative to the depicted “luer-slip” (Par. 55). It would have been obvious for one having ordinary skill in the art at the time the invention was made to construct the inner wall surface of the cap of Carr to comprise a luer-lock fitting to engage with a corresponding luer lock fitting on the exterior of the hub (16) of Carr in order to more securely engage the two components together with a known suitable alternative to the illustrated slip connection which is known to the prior art for its usefulness in securing the fitting against accidental disconnection, particularly when higher viscosity fluids are to be expelled.
Regarding Claim 20, Carr discloses a needle shield (812) coupled to the distal end of the tubular body and sealing the open cap tip.
Claim(s) 2, 5, 13, 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2017/0259004 (“Carr”) in view of WO 96/41649 (“Shemesh”) as applied above, and further in view of U.S. Patent No. 4,180,071 (“Oiwa”).
Regarding Claims 2 and 13, Carr discloses the invention substantially as claimed except that the inner wall surface of the tubular body defining radially inwardly directed lip abutting a proximal axial end of the needle seal and a retention shoulder abutting a distal axial end of the needle seal. Rather, Carr discloses that the seal may be held in the cap via “inward protrusions 838” (Par. 97) or an “interference fit” – although Carr does explicitly recognize that “there are many different ways to connect the various components…” For example, Oiwa disclose a related cap (1) which comprises an insert (2) indexed within the cavity formed by the inner wall surface of the tubular body, indexing means comprising a radially inwardly directed lip abutting a proximal axial end of the insert and a retention shoulder abutting a distal axial end of the insert (see Fig. 1). It would have been obvious for one having ordinary skill in the art at the time the invention was made to utilize corresponding proximal lips and distal shoulders to secure the seal insert of Carr, as disclosed by Oiwa, thereby only achieving the expected results of satisfying the disclosure of Carr to utilize well-known, means for connecting the components to obtain a predictable and expected outcome of holding the insert within the cap and preventing accidental dislodgement from the cap.
Regarding Claims 5 and 15, Carr discloses the tubular body defines a reduced diameter, necked portion intermediate the female Luer-taper profile, first cavity portion and the tapered, frusto-conical distal end thereof, the needle seal oriented distal said necked portion (see Fig. 17).
Claim(s) 3 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2017/0259004 (“Carr”) in view of WO 96/41649 (“Shemesh”) and U.S. Patent No. 4,180,071 (“Oiwa”) as applied above, and further in view of U.S. Patent No. 5,746,733 (“Capaccio”).
Regarding Claims 3 and 14, Carr discloses the needle seal is a separate component (see Fig. 17, 18) comprising an elastically deformable material (Par. 98). Although Carr does not explicitly characterize the material as an “elastomeric material” (i.e. an elastic polymer). However, Capaccio discloses that similar sealing elements (856) can be formed of “a wide variety of materials such as, natural rubber, synthetic rubber, thermoplastic elastomer and thermoplastic… softer materials such as natural rubber, synthetic rubber and thermoplastic elastomers are preferred”. It would have been obvious for one having ordinary skill in the art at the time the invention was made to construct the seal of modified Carr of an elastomer material, as disclosed by Capaccio, in order to allow the seal to resiliently deform about the cap inner wall and the received needle to improve the fluid tightness thereof. It has been held that selecting a known material recognized in the art for its suitability for a particular purpose requires only routine and customary skill in the art, see In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2017/0259004 (“Carr”) in view of WO 96/41649 (“Shemesh”) as applied above, and further in view of U.S. Patent No. 5,746,733 (“Capaccio”).
Regarding Claim 10, Carr discloses the needle seal is a separate component (see Fig. 17, 18) comprising an elastically deformable material (Par. 98). Although Carr does not explicitly characterize the material as an “elastomeric material” (i.e. an elastic polymer). However, Capaccio discloses that similar sealing elements (856) can be formed of “a wide variety of materials such as, natural rubber, synthetic rubber, thermoplastic elastomer and thermoplastic… softer materials such as natural rubber, synthetic rubber and thermoplastic elastomers are preferred”. It would have been obvious for one having ordinary skill in the art at the time the invention was made to construct the seal of modified Carr of an elastomer material, as disclosed by Capaccio, in order to allow the seal to resiliently deform about the cap inner wall and the received needle to improve the fluid tightness thereof. It has been held that selecting a known material recognized in the art for its suitability for a particular purpose requires only routine and customary skill in the art, see In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960).
Response to Arguments
Applicant’s arguments with respect to the claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 WILLIAM R CARPENTER whose telephone number is (571)270-3637. The examiner can normally be reached Mon. to Thus. - 7:00AM to 5:00PM (EST/EDT).
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/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783 02/02/2026