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 .
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.
Claim(s) 1-4, 9-14, 18 and 21-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Pre-Grant Publication 2018/0161243 to Ariagno et al. (Ariagno hereinafter), in view of U.S. Patent 4,259,187 to DeFrank et al. (DeFrank) and US Pre-Grant Publication 2020/0147300 to Novak et al. (Novak).
Regarding claim 1, Ariagno teaches a vial adapter (100, see Fig. 3) configured to interface with an infusion pump (paragraph 6, “vial adapter configured to… interconnect the vial with a delivery device such as… an injector or pump assembly”) configured to contain a medicament, a filter (140) within the adapter such that a flow of solution into the infusion pump from a medicament vial passes through the filter (paragraph 31, “configured to filter fluid content… passing through the channel 136”), the filter comprising a rigid ring (paragraph 31, “ semi-rigid elastomeric ring”) and a filter material (140). Ariagno does not teach that the filter comprises a rigid, porous plastic material that creates a three-dimensional tortuous path for the medicament flowing through the filter, the tortuous path trapping particulates in the medicament within the filter to remove the particulates. DeFrank teaches another infusion apparatus generally, and particularly teaches that a filter (32) is formed of rigid plastic material (col. 2, ln. 42-55) which forms a three-dimensional tortuous path for the medicament. DeFrank teaches that this structure advantageously filters particulates (col. 4, ln. 6-29). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to provide a hydrophobic, rigid, plastic filter as taught by DeFrank as the filter material of Ariagno in order to filter particulates. Neither Ariagno nor DeFrank explicitly teach pumping insulin. Novak teaches another infusion apparatus generally, and particularly teaches that insulin is filtered and pump to treat diabetes (see e.g. paragraph 112). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to pump insulin with the pump of Ariagno in order to treat diabetes thereby.
Regarding claim 2, Ariagno does not teach infusion tubing. DeFrank teaches infusion tubing (20) configured to connect a metering device (18) to an infusion site (14) on a body of a user to deliver medicament from the source (12) to the infusion site, wherein a second filter (32) is disposed within the infusion tubing. One of ordinary skill in the art would have found it obvious before the effective filing date of the application to provide infusion tubing as taught by DeFrank to the pump of Ariagno in order to deliver fluid to a patient.
Regarding claim 3, Ariagno does not teach the claimed filter location. DeFrank teaches that the infusion tubing includes a connector (22) configured to connect the infusion tubing to an infusion set (illustrated in Fig. 1) that extends from the connector to the infusion site and wherein the second filter (32) is disposed in the connector. One of ordinary skill in the art would have found it obvious before the effective filing date of the application to provide a connector as taught by DeFrank to the pump of Ariagno in order to deliver fluid to a patient.
Regarding claim 4, Ariagno does not teach an infusion set. DeFrank teaches an infusion set (10) that extends from the infusion tubing to the infusion site with the second filter (32) disposed therein. One of ordinary skill in the art would have found it obvious before the effective filing date of the application to provide an infusion set as taught by DeFrank to the pump of Ariagno in order to deliver fluid to a patient. The examiner notes that the infusion set of claim 4 is being interpreted as part of the infusion tubing of claim 2, otherwise a single filter would need to be disposed in two disparate locations.
Regarding claim 9, Ariagno teaches a filter head (paragraph 31, “semi-rigid elastomeric ring”) and a filter body (140).
Regarding claim 10, Ariagno teaches that the filter head is press fit into the lumen (138).
Regarding claim 11, Ariagno teaches a vial adapter (100, see Fig. 3) configured to interface with an infusion pump (paragraph 6, “vial adapter configured to… interconnect the vial with a delivery device such as… an injector or pump assembly”) configured to contain a medicament, a filter (140) within the adapter such that a flow of solution into the infusion pump from a medicament vial passes through the filter (paragraph 31, “configured to filter fluid content… passing through the channel 136”), the filter comprising a rigid ring (paragraph 31, “ semi-rigid elastomeric ring”) and a filter material (140). Finally, Ariagno teaches a filter head (128) and a flange (see Fig. 3, inside and in contact with 134) for supporting the filter above a lumen (136) and a filter body (138) extending down to be press fit into the lumen (paragraph 31). Ariagno does not teach that the filter comprises a rigid, porous plastic material that creates a three-dimensional tortuous path for the medicament flowing through the filter, the tortuous path trapping particulates in the medicament within the filter to remove the particulates. DeFrank teaches another infusion apparatus generally, and particularly teaches that a filter (32) is formed of rigid plastic material (col. 2, ln. 42-55) which forms a three-dimensional tortuous path for the medicament. DeFrank teaches that this structure advantageously filters particulates (col. 4, ln. 6-29). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to provide a hydrophobic, rigid, plastic filter as taught by DeFrank as the filter material of Ariagno in order to filter particulates. Neither Ariagno nor DeFrank explicitly teach pumping insulin. Novak teaches another infusion apparatus generally, and particularly teaches that insulin is filtered and pump to treat diabetes (see e.g. paragraph 112). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to pump insulin with the pump of Ariagno in order to treat diabetes thereby.
Regarding claim 12, Ariagno does not teach infusion tubing. DeFrank teaches infusion tubing (20) configured to connect a metering device (18) to an infusion site (14) on a body of a user to deliver medicament from the source (12) to the infusion site, wherein a second filter (32) is disposed within the infusion tubing. One of ordinary skill in the art would have found it obvious before the effective filing date of the application to provide infusion tubing as taught by DeFrank to the pump of Ariagno in order to deliver fluid to a patient.
Regarding claims 13-14, Ariagno does not teach the claimed filter location. DeFrank teaches that the infusion tubing includes a connector (22) configured to connect the infusion tubing to an infusion set (illustrated in Fig. 1) that extends from the connector to the infusion site and wherein the second filter (32) is disposed in the connector (which is within the infusion set). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to provide a connector as taught by DeFrank to the pump of Ariagno in order to deliver fluid to a patient.
Regarding claim 18, Ariagno does not teach the claimed filter location. DeFrank teaches that the infusion tubing includes an adapter (22) configured to connect the infusion tubing to an infusion set (illustrated in Fig. 1) that extends from the adapter to the infusion site and wherein the second filter (32) is disposed in the connector. One of ordinary skill in the art would have found it obvious before the effective filing date of the application to provide an adapter as taught by DeFrank to the pump of Ariagno in order to deliver fluid to a patient.
Regarding claims 21 and 22, DeFrank is silent as to dead ends and corners, however, these are plainly suggested to one of skill in the art by the “tortuous” nature of the filter. Accordingly, one of ordinary skill in the art would expect such features to be present in the filter of DeFrank as utilized in the apparatus of Ariagno and for those features to function as claimed as part of the filtering function thereof.
Claim(s) 5-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Pre-Grant Publication 2005/0277883 to Kriesel (Kriesel hereinafter) in view of U.S. Patent 4,259,187 to DeFrank et al. (DeFrank), US Pre-Grant Publication 2020/0147300 to Novak et al. (Novak) and US Pre-Grant Publication 2015/0057615 to Mernoe et al. (Mernoe hereinafter).
Regarding claim 5, Kriesel teaches an infusion pump system (Fig. 1), comprising: an infusion pump (40) configured to contain a medicament (paragraph 15); and a filter (96) disposed in relation to the infusion pump such that a flow of medicament into or out of the infusion pump passes through the filter (paragraph 138). Kriesel does not teach that the filter comprises a rigid, porous plastic material that creates a three-dimensional tortuous path for the medicament flowing through the filter, the tortuous path trapping particulates in the medicament within the filter to remove the particulates. DeFrank teaches another infusion apparatus generally, and particularly teaches that a filter (32) is formed of rigid plastic material (col. 2, ln. 42-55) which forms a three-dimensional tortuous path for the medicament. DeFrank teaches that this structure advantageously filters particulates without causing air blocking (col. 4, ln. 6-29). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to provide a hydrophobic, rigid, plastic filter as taught by DeFrank to the apparatus of Kriesel in order to filter particulates without air blocking. Neither Kriesel nor DeFrank explicitly teach pumping insulin. Novak teaches another infusion apparatus generally, and particularly teaches that insulin is filtered and pump to treat diabetes (see e.g. paragraph 112). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to pump insulin with the pump of Kriesel in order to treat diabetes thereby.
Kriesel does not explicitly teach a cannula configured to be inserted into a body of a user at an infusion site directly beneath the infusion pump. In place of the Official Notice taken in the previous action, the examiner cites herein to Mernoe as teaching an infusion catheter (similar to 952) placed beneath an infusion pump (1000, see paragraph 66) for infusion into a user. One of ordinary skill in the art would have found it obvious before the effective filing date of the application to use a pump and cannula directly therebeneath as taught by Mernoe in order to infuse insulin (paragraph 49) into the patient of Kriesel.
Regarding claim 6, with “around” read broadly to include “in the vicinity of”, Kriesel teaches that the filter is around the cannula.
Regarding claim 7, Kriesel teaches that the filter is positioned along a flow path of medicament between the infusion pump and the cannula.
Claim(s) 15-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ariagno in view of DeFrank and Novak as applied to claim 1 above, and further in view of Mernoe.
Regarding claim 15, Ariagno does not explicitly teach a cannula configured to be inserted into a body of a user at an infusion site directly beneath the infusion pump. In place of the Official Notice taken in the previous action, the examiner cites herein to Mernoe as teaching an infusion catheter (similar to 952) placed beneath an infusion pump (1000, see paragraph 66) for infusion into a user. One of ordinary skill in the art would have found it obvious before the effective filing date of the application to use a pump and cannula directly therebeneath as taught by Mernoe in order to infuse insulin (paragraph 49) into the patient of Ariagno.
Regarding claim 16, with “around” read broadly to include “in the vicinity of”, Ariagno teaches that the filter is around the cannula.
Regarding claim 17, Ariagno does not teach the claimed filter location. DeFrank teaches that the infusion tubing includes an adapter (22) configured to connect the infusion tubing to an infusion set (illustrated in Fig. 1) that extends from the adapter to the infusion site and wherein the second filter (32) is disposed in the connector. One of ordinary skill in the art would have found it obvious before the effective filing date of the application to provide an adapter as taught by DeFrank to the pump of Ariagno in order to deliver fluid to a patient, in which case the filter will be in the claimed positional range.
Response to Arguments
Applicant’s arguments, see page 5, filed 11 February 2026, with respect to the rejection(s) of claim(s) under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Ariagno and Mernoe, as set forth above.
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.
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/PHILIP E STIMPERT/Primary Examiner, Art Unit 3783 28 May 2026
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