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 .
Response to Amendment
The amendment filed on 03/23/26 has been entered in the case. Claims 1-3, 6-7, 9-13 are pending for examination; claims 14-22 are withdrawn and claim 8 is cancelled.
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.
(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 1-3, 6-7, 9-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wong (US 9,352,141).
Regarding claim 1, Wong discloses a drug delivery system 100 & 200 in Figs. 1-11 comprising:
a container 100 comprising a luer compartment 120 and/or 122 (Fig. 2) and a fluid compartment 106;
a luer fitting (inner threads 110 and/or outer threads 108, in Figs. 1-2) arranged within the luer compartment 120/122. For example: the luer fitting, i.e., inner threads 110 & inner wall of the interior space 120 is/are located inside the luer compartment 120/122, see marked-up Fig. 2 below; or the luer fitting, i.e. outer threads 108 is located inside the luer compartment 122; wherein the luer fitting 108/110 is configured to receive a syringe 200; and
a dispenser 102 in fluidic communication with the fluid compartment 106 (Figs. 3, 6-7).
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Another interpretation: a luer fitting (a nose or a protrusion of the syringe) arranged within the luer compartment and in fluidic communication with the fluid compartment; wherein the luer fitting is configured to receive a syringe.
Regarding claim 2, further comprising a cap (housing or cover 112 & 222) of configured to enclose the luer fitting within the luer compartment.
Regarding claim 3, wherein the luer compartment 120 and the fluid compartment 106 are on opposite ends of the container.
Regarding claim 6, wherein the container comprises a conduit 110 (Figs. 3 & 5) between the luer compartment 120 and the fluid compartment 106.
Regarding claim 7, as best as understood, wherein the luer fitting (nose of the syringe) is at least partially inserted in the conduit 110.
Regarding claim 9, wherein the luer fitting is coupled to the luer compartment via a fluidic seal (via friction fit, via threads or via seal 204).
Regarding claim 10, wherein the dispenser/syringe is coupled to the container 100.
Regarding claims 11-12, further comprising an adapter (including element 112 & 114), wherein the adapter comprises a first interface configured to couple to the container and a second interface configured to couple to the dispenser; wherein one of the first and second interfaces comprises a snap fit interface, and the other of the first and second interfaces comprises a threaded interface, see marked-up Fig. 5 below.
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Claims 2-3, 9-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chernack (US 4,402420).
Regarding claims 2-3, 9-10, Chernack discloses a drug delivery device system in Figs. 1-5 comprising:
a container 10 comprising a luer compartment 16 and a fluid compartment 22;
a luer fitting (19/19b or inner threads 18, see Fig. 2 or marked-up Fig. 4 below) arranged within the luer compartment 16 and in fluidic communication with the fluid compartment 22, wherein the luer fitting is configured to receive a syringe 42; and
a dispenser 35 in fluidic communication with the fluid compartment 102;
(as for claim 2) a cap 20 & 27 (see Fig. 1-2) configured to enclose the luer fitting within the luer compartment;
(as for claim 3) wherein the luer compartment 16 and the fluid compartment 22 are on opposite ends of the container 10;
( as for claims 9-10) the luer fitting is coupled to the luer compartment via fluidic seal (by friction fit or via threads); the dispenser 35 is coupled to the container 10.
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Claims 3, 6-7 & 10-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jepson et al. (US 5,871,500).
Regarding claims 3, 6-7 & 10-12, Jepson discloses a drug delivery device system in Figs. 4A-4B comprising:
a container 80 comprising a luer compartment 96 and a fluid compartment 99;
a luer fitting 92, 94 & 98 (see Fig. 4A) arranged within the luer compartment 96 and in fluidic communication with the fluid compartment 99 (or/and 68); wherein the luer fiting is configured to receive a syringe 82;
Note: a piercing member 98 is a part of luer fitting is arranged in the luer compartment 96
a dispenser 36 (see #36 in Fig. 2B) in fluidic communication with the fluid compartment 99, see Figs. 4A-4B;
(as for claim 3), wherein the luer compartment 96 and the fluid compartment 68 are on opposite end of the container;
(as for claim 6) wherein the container 80 comprises a conduit 40 between the luer compartment and the fluid compartment;
(as for claim 7), wherein the luer fitting 98 is at least partially inserted in the conduit 40;
(as for claim 10), wherein the dispenser 36 is coupled to the container 80 (via #40, see Fig. 2B) ;
(as for claim 11), an adapter 40 comprises a first interface 42 & 52 configured to couple to the container 80; and second interface 48 confiugred to couple to the dispenser 36, see Fig. 2B;
(as for claim 12), wherein one of the first and second interfaces (in this case, the first interface) comprises a snap fit interface, and the second interface comprises a threaded interface 48.
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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.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Wong (US 9,352,141) in view of Vlodaver et al. (US 8,568,348)
Regarding claim 13, Wong discloses all claimed subject matter as required in the claim 1 above except for the limitation that the dispenser comprises an eyedropper.
Vlodaver discloses medication applicator such as an ear dropper, an eye dropper, a syringe, or similar device, col. 5, lines 61-64, comprising: a dispenser (syringe 100) comprises an eyedropper 14 (Fig. 18) or 190 (Fig. 26) being connected to a nose 102 of the syringe for dispensing fluid into the eye or nose.
It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the dispenser/syringe device of Wong with providing an eyedropper, as taught by Vlodaver, in order to introduce a medicament into the eye.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Chernack (US 4,402420) in view of Dionigi (WO 2022/233866).
Regarding claim 13, Chernack discloses a drug delivery device system in Figs. 1-5 comprising:
a container 10 comprising a luer compartment 16 and a fluid compartment 22;
a luer fitting (19/19b or inner threads 18, see Fig. 2 or marked-up Fig. 4 below) arranged within the luer compartment 16 and in fluidic communication with the fluid compartment 22, wherein the luer fitting is configured to receive a syringe 42; and
a dispenser 35 in fluidic communication with the fluid compartment 102.
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Chernack does not disclose that the dispenser comprises an eyedropper.
Dionigi discloses a drug delivery system in Fig. 1 comprising: a container 51 comprising: a luer compartment 55; and a fluid compartment Z, a dispenser 7 in fluidic communication with the fluid compartment; wherein the dispenser 7 comprises an eyedropper 11, see page 1, line 15 & page 24, line 11.
It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the dispenser device of Chernack with providing an eyedropper (at bottom end of the dispenser), as taught by Dionigi, in order to introduce a medicament into the eye.
Claims 1 & 13 are rejected under 35 U.S.C. 103 as being unpatentable over Dionigi (WO 2022/233866).
Regarding claim 1, Dionigi discloses a drug delivery system 100 comprising:
a container 51 comprising a luer compartment 55 and a fluid compartment 61;
a luer fitting 53 (or 54) arranged within the luer compartment 55 and in fluidic communication with the fluid compartment 61, see Fig. 2; wherein the luer fitting 53/54 is configured to receive a syringe (see Note below); and
a dispenser 7 in fluidic communication with the fluid compartment 102.
Note: it has been held that the recitation that the luer fitting is “configured to” (to receive a syringe) performing a function is not a positive limitation but only requires the ability to so perform. It does not constitute a limitation in any patentable sense. In re Hutchison, 69 USPQ 138. In this case, the container 51 is a Luer-connector; therefore, a person skilled in the art would recognize that the threads 53 or a nose 54 is capable of receiving a syringe.
Evidence: Choksi et al. (US 4,046,145) shows that a container/connector 28 comprising a nose 24; wherein the nose 22 is configured to receive a syringe 56. The nose 22 in Choksi is similar to the nose 54 in Dionigi. Therefore, the nose 54 is capable of receiving a syringe. It is noted that the limitation, i.e. luer fitting “is configured to receive a syringe” is functional limitation. In other words, the limitation “a syringe” is not a positive limitation. Therefore, the prior art Dionigi does not need to include “a syringe” in the drug delivery system. As long as the nose 54 is capable of receiving a syringe, then it meets the claimed limitation. In this case, the nose 54 is able to receive a syringe.
Regarding claim 13, wherein the dispenser comprises an eyedropper 11, page 24, line 11.
Response to Arguments
Applicant's arguments filed 03/23/26 have been fully considered but they are not persuasive.
Applicant argues that the luer 210 of the syringe delivery mechanism 200 in Wong is not configured to receive a syringe.
In response, the claimed invention does not require that the luer fitting must be separated component of the syringe. With broadest interpretation, the luer fitting , i.e., a nose is being attached to a syringe and considered as receiving a syringe. In addition, a luer fitting (inner threads 110 and/or outer threads 108, in Figs. 1-2) arranged within the luer compartment 120/122. For example: the luer fitting, i.e., inner threads 110 is located inside the luer compartment 120/122; or the luer fitting, i.e. outer threads 108 is located inside the luer compartment 122; wherein the luer fitting 108/110 is configured to receive a syringe 200, see Fig. 2 below.
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2) Applicant argues that nowhere in Dionigi discloses a connecting accessory 51 and/or collar 9 are configured to receive a syringe nor that the deformable container kit as a whole can employ a syringe.
In response to applicant's argument, the functional recitation, i.e., the luer fitting that “is configured to receive a syringe” has not been given patentable weight because it is narrative in form. The recitation of the functional limitation only requires to performing a function. If the prior art structure is capable of performing the intended used, and then it meets the claim languages. In this case, the container 51 is a Luer-connector; therefore, a person skilled in the art would recognize that the threads 53 or a nose 54 is capable of receiving a syringe.
Evidence: Choksi et al. (US 4,046,145) shows that a container/connector 28 comprising a nose 24; wherein the nose 22 is configured to receive a syringe 56. The nose 22 in Choksi is similar to the nose 54 in Dionigi. Therefore, the nose 54 is capable of receiving a syringe. It is noted that the limitation, i.e. luer fitting “is configured to receive a syringe” is functional limitation. In other words, the limitation “a syringe” is not a positive limitation. Therefore, the prior art Dionigi does not need to include “a syringe” in the drug delivery system. As long as the nose 54 is capable of receiving a syringe, then it meets the claimed limitation. In this case, the nose 54 is able to receive a syringe.
Examiner Notes
Examiner cites particular columns and line numbers in the references as applied to the claims above for the convenience of the applicant. Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
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 QUYNH-NHU HOANG VU whose telephone number is (571)272-3228. The examiner can normally be reached M-F 7:30 am-4:00 pm.
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/QUYNH-NHU H. VU/ Primary Examiner, Art Unit 3783