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 5/12/2026 has been entered. Claims 1-11 and 20-23 remain pending in the application. Applicant’s amendments to the Claims have overcome each and every 112(b) rejections previously set forth in the Non-Final Office Action mailed 3/13/2026.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 4/17/2026 was filed after the mailing date of the Non-Final Office Action on 3/13/2026. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
Claim(s) 1, 2, 7-9 and 20-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Grinberg (US 2008/0255523 A1).
Regarding claim 1, Grinberg teaches a fluid delivery device (paragraph 0099, examiner construes “fluid delivery device” as being a device comprising the component shown in figure 19 along with the syringe, needle and vial connected to the component) comprising:
a reservoir (paragraph 0099, hollow portion inside “syringe”) configured to carry medicament, the reservoir comprising an outlet port (paragraph 0099, outlet of “syringe” connected to element 191);
an insertion mechanism (paragraph 0099, “hypodermic needle”) that delivers medicament to a patient;
a vial connector system (figure 19) configured to engage and disengage a vial 14 (figure 18, paragraph 0099, lines 8-10) for filling of the medicament into the reservoir; and
a fluid path (path formed inside element 19, “needle” and any other component that enables connection of the syringe with element 191) comprising an outlet fluid path (path of fluid from “syringe” to “needle”) from the outlet port of the reservoir to the insertion mechanism, the outlet fluid path establishing fluid communication between the reservoir and the insertion mechanism; wherein
the vial connector system (figure 19) is disposed in the outlet fluid path between the outlet port of the reservoir (paragraph 0099, “syringe”) and the insertion mechanism such that: (1) during delivery of the medicament to the patient, the medicament exits (paragraph 0100) the reservoir and travels to the insertion mechanism through the vial connector system, and (2) during filling of the medicament into the reservoir, the vial connector system selectively establishes fluid communication with the vial (paragraph 0100).
Regarding claim 2, Grinberg teaches wherein the vial connector system includes retaining features 8 (paragraph 0092, lines 11-14) for mating with the vial 14.
Regarding claim 7, Grinberg teaches wherein the vial connector system (figure 19) includes a check valve 195 (paragraph 0100, lines 1-4) to prevent the vial connector system (figure 19) from dispensing the medicament to the vial 14.
Regarding claim 8, Grinberg teaches where in the insertion mechanism (paragraph 0099, “hypodermic needle”, examiner construes element 196 as a part of the insertion mechanism because even applicant considers element 172 in applicant’s figure 4 as a part of element 116 in applicant’s figure 4 even though element 172 is located outside element 116) includes a check valve 196 to prevent the insertion mechanism from filling the reservoir (paragraph 0100, lines 4-8).
Regarding claim 9, Grinberg teaches further comprising at least two check valves 195, 196 in the fluid path to control the medicament flow during the filling and during operation.
Regarding claim 20, Grinberg teaches wherein the at least two check valves 195, 196 include a first check valve 195 in the vial connector system and a second check valve 196 in the insertion mechanism (paragraph 0099, “hypodermic needle”, examiner construes element 196 as being located in the “hypodermic needle” because even applicant considers element 172 in applicant’s figure 4 in the element 116 in applicant’s figure 4 even though element 172 is located outside element 116).
Regarding claim 21, Grinberg teaches wherein the vial connector system (figure 19) is integrated into the fluid delivery device (paragraph 0099, examiner construes “fluid delivery device” as being a device comprising the component shown in figure 19 along with the syringe, needle and vial connected to the component) for filling the reservoir.
Regarding claim 22, Grinberg teaches wherein all tools used for filling are disposed in the fluid delivery device (no additional or external tool use is recommended or disclosed) such that no further devices or components are needed for filling.
Regarding claim 23, Grinberg teaches wherein the vial connector system remains disposed in the outlet fluid path between the reservoir and the insertion mechanism during delivery of the medicament to the patient (paragraph 0100).
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 3, 4 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Grinberg (US 2008/0255523 A1) in view of Mijers et al. (US 2020/0146939 A1).
Regarding claim 3, Grinberg discloses the claimed invention substantially as claimed, as set forth above in claim 1. Grinberg further discloses the vial connector system includes a needle 53 for filling the reservoir but is silent regarding a needle being a retractable needle.
However, Mijers teaches a design of a transfer apparatus (figure 2) comprising a needle 8 being a retractable needle (due to extension of element 11, element 8 is construed as a retractable needle) for the purpose of covering the needle when the vial is not connected to the device thereby protecting the needle from accidents (paragraph 0046, lines 11-24).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the needle of Grinberg to incorporate a retractable needle as taught by Mijers for the purpose of covering the needle when the vial is not connected to the device thereby protecting the needle from accidents (paragraph 0046, lines 11-24).
Regarding claim 4, Grinberg discloses the claimed invention substantially as claimed, as set forth above in claim 1. Grinberg is silent regarding wherein the vial connector system includes a safety cap for shielding the retractable needle.
However, Mijers teaches wherein the vial connector system (figure 4) includes a safety cap 37 for shielding the retractable needle for the purpose of protecting the connector from impurities (paragraph 0050, lines 13-17).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the vial connector system of Grinberg to incorporate wherein the vial connector system includes a safety cap for shielding the retractable needle as taught by Mijers for the purpose of protecting the connector from impurities (paragraph 0050, lines 13-17).
Regarding claim 6, Grinberg discloses the claimed invention substantially as claimed, as set forth above in claim 1. Grinberg is silent regarding wherein the retractable needle retracts automatically.
However, Mijers teaches wherein the retractable needle 8 retracts automatically (paragraph 0046, lines 17-24) for the purpose of covering the needle when the vial is not connected to the device thereby protecting the needle from accidents (paragraph 0046, lines 11-24).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing of the claimed invention to modify the needle of Grinberg to incorporate wherein the retractable needle retracts automatically as taught by Mijers for the purpose of covering the needle when the vial is not connected to the device thereby protecting the needle from accidents (paragraph 0046, lines 11-24).
Claims 3 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Grinberg (US 2008/0255523 A1) in view of Carilli (US 5,709,667).
Regarding claim 3, Grinberg discloses the claimed invention substantially as claimed, as set forth above in claim 1. Grinberg further discloses the vial connector system includes a needle (see “N” in figure 1 above) for filling the reservoir but is silent regarding a needle being a retractable needle.
However, Carilli teaches a design of a needle protection system (figure 1) comprising a retractable needle 30 for the purpose of protecting the personnel from accidental stab (column 1, lines 16-20).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention before the effective filing of the claimed invention to modify the needle of Grinberg to incorporate a retractable needle as taught by Carilli for the purpose of protecting the personnel from accidental stab (column 1, lines 16-20).
Regarding claim 5, Grinberg discloses the claimed invention substantially as claimed, as set forth above in claim 1. Grinberg is silent regarding wherein the retractable needle retracts manually.
However, Carilli teaches wherein the retractable needle retracts manually (column 5, lines 14-17) for the purpose of protecting the personnel from accidental stab (column 1, lines 16-20).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the needle of Grinberg to incorporate wherein the retractable needle retracts manually as taught by Carilli for the purpose of protecting the personnel from accidental stab (column 1, lines 16-20).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Grinberg (US 2008/0255523 A1) in view of Searle et al. (US 2016/0074587 A1).
Regarding claim 10, Grinberg discloses the claimed invention substantially as claimed, as set forth above in claim 1. Grinberg is silent regarding comprising a gyroscopic chip to provide orientation feedback of the fluid delivery device during filling operation.
However, Searle teaches a design of a syringe with a vial connector (figure 13) comprising a gyroscopic chip to provide orientation feedback of the fluid delivery device during filling operation (paragraph 0057, lines 17-19) for the purpose of providing orientation information to perform an appropriate action such as air purge or filling operation (paragraph 0057, lines 17-19).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, to modify the fluid delivery device of Grinberg to incorporate a gyroscopic chip to provide orientation feedback of the fluid delivery device during filling operation as taught by Weston for the purpose of providing orientation information to perform an appropriate action such as air purge or filling operation (paragraph 0057, lines 17-19).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Grinberg (US 2008/0255523 A1) in view of Dominiak et al. (US 5,478,211).
Regarding claim 11, Grinberg discloses the claimed invention substantially as claimed, as set forth above in claim 1. Grinberg further discloses a motor 4. Weston is silent regarding a motor including an H-bridge chip that allows the motor to change direction and generate a vacuum pressure for the filling operation.
However, Dominiak teaches a design of an ambulatory infusion pump comprising motor including an H-bridge chip (column 24, lines 49-59) that allows the motor to change direction and generate a vacuum pressure for the filling operation (column 22, lines 62-67, change in direction and refilling is being taught and therefore, H-bridge chip is capable to generate vacuum) for the purpose of the purpose of using a well-known approach to drive the motor in an appropriate direction (column 24, line 49-59).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the motor of Grinberg to incorporate a motor including an H-bridge chip that allows the motor to change direction and generate a vacuum pressure for the filling operation as taught by Dominiak for the purpose of the purpose of using a well-known approach to drive the motor in an appropriate direction (column 24, line 49-59).
Response to Arguments
Applicant’s arguments with respect to claim 1 have been considered but are moot because the arguments do not apply in view of the present rejection.
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 NILAY J SHAH whose telephone number is (571)272-9689. The examiner can normally be reached Monday-Thursday 8:00 AM-4:30 PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, CHELSEA STINSON can be reached at 571-270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NILAY J SHAH/Primary Examiner, Art Unit 3783
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