DETAILED ACTION
Response to Amendment
The amendment filed March 12, 2026 has been entered. Claims 1, 8-10, 12-13, 15-16, and 18-27 have been amended with claims 3 and 7 having been cancelled. Claims 1, 2-6, and 8-27 are currently pending in the application.
Response to Arguments
Applicant's arguments filed March 12, 2026 have been fully considered but they are not persuasive. Regarding Applicant’s arguments that Chattaraj fails to teach the claimed device, the Examiner respectfully disagrees. Chattaraj discloses a connector system 270 which comprises a filter element 324 therein. Claim 1 requires that the filter plug fills the outlet volume and not that the filter element itself fills the entire outlet volume as argued. The plug comprises the connector which can be clearly seen in Figure 5 to completely fill the outlet volume of the chamber from the cartridge receptacle and through the conduit so that the drug is filtered as is passes through the connector assembly. This is considered to substantially disclose the claim limitations as currently set forth. Regarding Applicant’s arguments as to claim 23, the Examiner maintains that Lickliter teaches that it is known to use a cannula to fluidly connect two elements in a medical device to create a fluid pathway between the two elements. Chattaraj teaches the use of one fluid pathway connection and only fails to disclose connecting the outlet conduit through the connector via a second fluid pathway. Lickliter clearly provides motivation for using a pierceable fluid pathway connection to fluidly couple two elements together and such a method would have been obvious to one of ordinary skill when provided with the cited disclosures. The rejection is considered proper and is maintained below.
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.
Claim(s) 1, 2, 4-6, and 8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chattaraj et al. (US 2017/0312454).
Regarding claim 1, Chattaraj et al. (henceforth Chattaraj) discloses (Figures 1-5) a drug delivery device (100), comprising: a reservoir (256) operable to contain a liquid drug; a fluid outlet (306, 320, 322) including an outlet reservoir opening (opening of bore 322 to reservoir 256) and an outlet fluid channel (306), wherein the outlet reservoir opening has a volume and is fluidly coupled to the outlet fluid channel (Figure 3); and an outlet filter plug inserted into an outlet volume of the outlet reservoir opening (270 including filter 324, Figures 4-5; ¶¶ [0049]-[0050]; it can be clearly seen that the connector 270, which comprises the filter element 324 completely fills the outlet reservoir volume as claimed; the claim does not require the filter element to fill the volume on its own), and operable to fill the volume of the outlet reservoir opening and collect particulate material as the liquid drug is expelled from the reservoir (¶¶ [0053]-[0054]).
Regarding claim 2, Chattaraj further discloses wherein the outlet filter plug comprises a porous material having a pore size of about 1 micrometer to about 10 micrometers (¶ [0050] discloses a pore size of 0.45 microns – 5 microns depending on the desired level of filtration).
Regarding claim 4, Chattaraj further discloses wherein the outlet filter plug is operable to absorb phenolic preservatives in the liquid drug (Chattaraj discloses the claimed filter pore size and that it is designed to filter particulate matter from the liquid drug as per ¶ [0050]; for this reason, the filter of Chattaraj is disclosed as structurally analogous in form and pore size as that disclosed and will be able to filter the claimed phenolic preservatives as a function of this disclosed structure).
Regarding claim 5, Chattaraj further discloses wherein the outlet filter plug is operable to collect precipitant in the liquid drug (¶ [0050]).
Regarding claim 6, Chattaraj further discloses wherein the outlet filter plug comprises: a porous silica material, a porous alumina material, a porous polymeric material, or a combination thereof (¶ [0050] provides examples of polymeric materials for the filter element).
Regarding claim 8, Chattaraj further discloses wherein the outlet filter plug comprises an adsorption layer (see ¶ [0054] which discloses a filter layer for absorbing/adsorbing desired particulate matter).
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) 9-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chattaraj in view of Andersson et al. (US 5,936,061).
Regarding claims 9-11, Chattaraj discloses the claimed invention substantially as set forth above for claim 9, but fails to explicitly disclose the use of a porous structure of zeolite in the adsorption layer.
Andersson et al. (henceforth Andersson) teaches a filter comprising zeolite Y for removing preservatives from a liquid solution (see Col. 5, lines 54-67 which disclose the use of zeolite Y for removing phenol from insulin solutions; see also Col. 6, lines 38-45 which disclose forming a “filter assembly” via packing zeolite Y between filter frits to pass through a syringe assembly).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the filter assembly of Chattaraj to include zeolite Y in the adsorption layer as it has shown efficient removal of phenol from insulin solutions for patient injection as taught by Andersson.
Claim(s) 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chattaraj in view of Moro et al. (US 4,746,516).
Regarding claims 12-13, Chattaraj discloses the claimed invention substantially as set forth above for claim 9, but fails to explicitly disclose the use of a chelator in the adsorption layer.
Moro et al. (henceforth Moro) teaches the use of EDTA as a chelating agent for a drug composition (Col. 5, line 64-Col. 6, line 2).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the filter later of Chattaraj to include a chelating agent such as EDTA so as to bind to metallic ions to retain them within the filter assembly if desired as taught by Moro.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chattaraj in view of McConnell et al. (US 2002/0173748).
Regarding claim 14, Chattaraj discloses the claimed invention substantially as set forth above for claim 1, and further discloses connection of the outlet filter plug to an infusion set (¶ [0029]; it is well-established in the art that an infusion set will include a needle or cannula within the patient for providing a means of connecting the reservoir to the patient for infusion), however, Chattaraj fails to explicitly disclose the hard cannula or needle after the outlet filter plug.
McConnell et al. (henceforth McConnell) teaches a connector assembly for a fluid reservoir which is connected to the patient via a needle or cannula (see e.g., ¶ [0033] which discloses the attachment of the fluid reservoir 1 to an infusion set tubing or an external needle for infusion into the patient).
It would have been obvious to one of ordinary skill in the art at the time of filing to utilize the needle attachment of McConnell with the infusion set assembly of Chattaraj as it is known in the art to use a needle inserted into a patient to perform an infusion procedure as taught by McConnell.
Claim(s) 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chattaraj in view of McConnell in view of Shmulewitz et al. (US 6,569,145), and further in view of Wu et al. (US 2011/0276025).
Regarding claim 15, Chattaraj/McConnell teach the claimed invention substantially as set forth above for claim 14, and further teach the infusion of insulin (¶ [0026] of Chattaraj) but fail to explicitly disclose a duckbill valve in the cannula or needle.
Shmulewitz et al. (henceforth Shmulewitz) teaches an indwelling cannula (catheter of Figures 6A-6C) comprising a duckbill valve (72a-72c) for controlling fluid flow through the cannula (Col. 7, lines 31-44).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the cannula of the infusion set of Chattaraj/McConnell to comprise the duckbill valves of Shmulewitz to allow for control of the fluid flow through the distal end of the cannula as taught by Shmulewitz.
In addition, Chattaraj/McConnell/Shmulewitz fail to explicitly disclose that the cracking pressure is operable to allow a hexamer form of the drug to pass through the cannula, however, Wu et al. (henceforth Wu) teaches that it is known to utilize the hexamer form of insulin in an infusion reservoir for delivery to a patient (¶ [0038]). Therefore it would have been obvious to utilize such a form of insulin in the delivery device of Chattaraj as it is known for use in such devices. Furthermore, if the hexamer form was used, it would have been obvious to design the valves with a cracking pressure allowing for the infusion of the insulin so that the device functions as intended.
Regarding claim 16, Shmulewitz further teaches wherein the duckbill valve is positioned at the distal end of the hard cannula (see e.g., Figure 1A, the valved section is at the distal end of the assembly).
Claim(s) 17-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chattaraj in view of Tai et al. (US 2013/0116664).
Regarding claim 17, Chattaraj discloses the claimed invention substantially as set forth above for claim 1, but fails to explicitly disclose the inlet assembly and associated structure.
Tai et al. (henceforth Tai) teaches (Figures 4B and 7A) an assembly comprising a fluid inlet (injection port (analogous to the infusion set of Watson) comprising: a fluid inlet including an inlet septum (see annotated figure below), an inlet fluid channel (outlet of septum and into fluid receiving portion of inlet reservoir; see annotated figure below), and an inlet reservoir opening (distal of the inlet septum; see annotated figure below), wherein the inlet reservoir opening has an inlet volume and is fluidly coupled to the reservoir (the area distal to the inlet septum feeds the reservoir of the device through the fluid channel); and an inlet filter plug (462, Figure 4B; ¶ [0031]) operable to fill the volume of the inlet fluid channel (the filters prevent unwanted molecules from entering the reservoir chamber).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the inlet of the delivery system of Chattaraj to allow for a refillable container system so as to provide a means of refilling the device to allow for multiple uses without needing to access the internal environment of the pump as taught by Tai. Furthermore, it would have been obvious to utilize the filters of Chattaraj in the refill lines so as to ensure that the desired particulate matter is filtered out during a refill procedure to maintain the desired integrity of the drug being infused.
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Regarding claim 18, Tai further teaches an inlet septum operable to seal the inlet fluid channel from an exterior of the drug delivery device (see annotated figure above).
Regarding claim 19, the combined device, utilizing the filters of Chattaraj, would be of a size to absorb phenolic preservatives from the liquid drug as set forth above for claim 4.
Regarding claim 20, the combined device, utilizing the filters of Chattaraj, would be of a size to collect precipitant in the liquid drug as set forth above for claim 5.
Regarding claim 21, Chattaraj/Tai further teach a hard cannula (Chattaraj teaches the use of an infusion set which are known to utilize needles or cannulas for connecting the device to a patient, and Tai teaches that a cannula is included to guide liquid drug from the reservoir to an injection site as per ¶ [0006]). It would have been obvious to one of ordinary skill in the art at the time of filing to utilize the cannula of Tai with the infusion set of Chattaraj as it provides a well-known means of attaching an infusion pump assembly to a patient for performing an infusion procedure.
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chattaraj in view of Tai in view of Wu, and further in view of Shmulewitz.
Regarding claim 22, Chattaraj/Tai teach the claimed invention substantially as set forth above for claim 18, but fail to disclose the duckbill valve within the cannula.
Shmulewitz et al. (henceforth Shmulewitz) teaches an indwelling cannula (catheter of Figures 6A-6C) comprising a duckbill valve (72a-72c) for controlling fluid flow through the cannula (Col. 7, lines 31-44).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the cannula of the infusion set of Chattaraj/Tai to comprise the duckbill valves of Shmulewitz to allow for control of the fluid flow through the distal end of the cannula as taught by Shmulewitz.
In addition, Chattaraj/Tai/Shmulewitz fail to explicitly disclose that the cracking pressure is operable to allow a hexamer form of the drug to pass through the cannula, however, Wu et al. (henceforth Wu) teaches that it is known to utilize the hexamer form of insulin in an infusion reservoir for delivery to a patient (¶ [0038]). Therefore it would have been obvious to utilize such a form of insulin in the delivery device of Chattaraj as it is known for use in such devices. Furthermore, if the hexamer form was used, it would have been obvious to design the valves with a cracking pressure allowing for the infusion of the insulin so that the device functions as intended.
Claim(s) 23-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chattaraj in view of Lickliter (US 2003/0205901).
Regarding claim 23, Chattaraj discloses drug delivery device, comprising: a reservoir (256) operable to contain a liquid drug; a fluid outlet (306, 320, 322) including an outlet reservoir opening (opening of bore 322 to reservoir 256) and an outlet fluid channel (306); a filtration module (324 and bore before and after filter) having an inlet (between needle 272 and filter; ¶ [0049]), a filter (324) and an outlet (through tubing 210); and the filter is comprised of a porous material, wherein the porous material is a porous silica material, a porous alumina material, a porous polymeric material, or a combination thereof (¶¶ [0053]-[0054]). Chattaraj further discloses an inlet needle (272) for delivering fluid from the reservoir to the filter, but not an outlet needle after the filter assembly.
Lickliter teaches a connector device (100) for a medical fluid system (Figures 1A-1B) comprising an outlet needle as a fluid pathway (116) for connection to a fluid source (e.g., 102).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the connection of the cap assembly of Chattaraj to comprise a pierceable connection between the fluid source and infusion set to ensure a self-sealing removable connection between the two elements as taught by Lickliter. Such a feature would replace the cap as a different means of attaching the infusion set while retaining the desired features of the device of Chattaraj.
Regarding claim 24, Chattaraj further discloses wherein the outlet filter plug comprises a porous material having a pore size of about 1 micrometer to about 10 micrometers (¶ [0050] discloses a pore size of 0.45 microns – 5 microns depending on the desired level of filtration).
Regarding claim 25, Chattaraj further discloses wherein the inlet of the filtration module comprises a pierceable inlet septum (268 may be considered part of the filtration module as it connects the reservoir to the filtration module; Figure 3).
Regarding claim 26, Lickliter further teaches a pierceable outlet septum (108, 126).
Regarding claim 27, the combined devices teaches a first needle segment (of needle 272) for piercing the inlet septum (268), and Lickliter teaches a second needle segment (116) for piercing the outlet septum (Figure 1B).
Conclusion
THIS ACTION IS MADE FINAL. 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 JUSTIN L ZAMORY whose telephone number is (571)270-1238. The examiner can normally be reached M-F 8:30am-4:30pm ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at 571-270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JUSTIN L ZAMORY/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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