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 07/27/2026 has been entered. Claims 1, 12, and 18 have been amended. Claims 2-11, 13-17, and 19-20 are in the original/previously presented form. Thus, claims 1-20 remain pending in the application. Of these claims, claims 18-20 are withdrawn.
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3, and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Michaud et al. (United States Patent Application Publication No. US 2016/0339172 A1; herein, Michaud), and further in view of Constantineau et al. (United States Patent Application Publication No. US 2012/0143136 A1; herein, Constantineau).
Regarding claim 1, Michaud discloses a drug infusion system (Figs. 4B/5B) including a drug delivery device (pump 102), the drug infusion system having a tethered configuration (Figs. 5A/5B) and a patch configuration (Figs. 4A/4B): an infusion head (infusion site connector 148) having a first adhesive pad (infusion site patch 190) and an injection device (cannula 188); a holder (retention frame 106), the holder configured to couple to and support the drug delivery device in the patch configuration (Figs. 1C-1F, [0028], snap portion 115 of retention frame 106 snaps into place when aligned with the recess 139 of pump 102).
Michaud does not explicitly disclose an applicator assembly configured for use with the drug infusion system; the holder having a second adhesive pad; a housing configured to carry the infusion head and the holder, the infusion head and the holder each being selectively releasable from the housing for adherence to a patient's skin; and an actuator coupled to the housing and configured to move the injection device from the housing into the patient's skin.
However, Constantineau teaches an applicator assembly configured for use with the drug infusion system (FIG. 3A, ballistic inserter 200 and infusion set 100); the holder having a second adhesive pad ([0040], “an adhesive covering backing…can be peeled off one or both of the skin adhesive layers 110 and 112 of the infusion set 100”; The two components that make contact with the skin, the surrounding member 106 which contains adhesive 110 and the inner hub 104 which contains adhesive 112, can have separate adhesive covering backings which can be independently removed.); a housing (lower inserter housing 204) configured to carry the infusion head and the holder (FIG. 8, [0033], [0048], The lower inserter housing 204 comprises attachment arms with snaps 205 for securing the lower inserter housing 204 to the rail 122 of the outer hub 102 of infusion set 100), the infusion head and the holder each being selectively releasable from the housing for adherence to a patient's skin (FIG. 3A – FIG. 5, [0033], [0040], [0041], [0048], Both the inner hub 104 and surrounding member 106 have the independent ability to be released from the ballistic inserter and adhered to the skin.); and an actuator (button 202) coupled to the housing (FIG. 3A, [0034], “The button 202 is configured to slidably engage the lower inserter housing 204”) and configured to move the injection device from the housing into the patient's skin ([0036]-[0037], specifically in [0040] “The user then presses downward on the inserter button 202, loading the spring 208, releasing the hammer 208 to strike the table 212, which moves the inner hub 104, placing the inner hub 104 of the infusion set at the infusion site and inserting the needle 108 into the skin surface of the infusion site.”). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the drug infusion system disclosed by Michaud to be functional with the applicator assembly, including the housing and actuator taught by Constantineau in order to ensure proper alignment and positioning of the drug infusion system on a patient’s skin ([0052]).
Regarding claim 2, in the modified assembly of Michaud, Michaud discloses for the tethered configuration (Figs. 5A/5B), the adhesive pad of the infusion head is exposed to the patient's skin (Fig. 12A, after removing the backing of the adhesive, the infusion site connector 148 can be attached to the skin); and for the patch configuration (Figs. 4A/4B), the adhesive pad of the infusion head is exposed to the patient's skin and the adhesive pad of the holder is exposed to the patient's skin (Fig. 11A-E).
Further, Constantineau teaches the applicator assembly has a preparation state (FIG. 3A, ballistic inserter 200 and infusion set 100 prior to activation), and specifies the first adhesive pad and the second adhesive pad ([0040], “an adhesive covering backing…can be peeled off one or both of the skin adhesive layers 110 and 112 of the infusion set 100”; The two components that make contact with the skin, the surrounding member 106 which contains adhesive 110 and the inner hub 104 which contains adhesive 112, can have separate adhesive covering backings which can be independently removed.), and at times, the adhesive pad of the holder is concealed from the patient's skin ([0040], The two components that make contact with the skin, the surrounding member 106 which contains adhesive 110 and the inner hub 104 which contains adhesive 112, can have separate adhesive covering backings which can be independently removed.). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified drug infusion system as disclosed by Michaud to define the pre-injection state of the device as shown in Constantineau as a preparation state, as it is known in the art that any injectable device would need to have a pre-injection state. Further, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified drug infusion system as disclosed by Michaud to have two separate adhesive pads as taught by Constantineau in order to give the user the decision of peeling of one or both of the backings of the adhesive pads ([0040]).
Regarding claim 3, in the modified assembly of Michaud, Michaud discloses the holder further includes a removeable backing that conceals the second adhesive pad in the tethered configuration (adhesive backing 107 covers the adhesive of the retention frame 106).
Regarding claim 6, in the modified assembly of Michaud, Michaud discloses in which the infusion head is adhered to the patient's skin (FIG. 12A, after removing the backing of the adhesive, the infusion site connector 148 can be attached to the skin).
Further, Constantineau teaches an alignment guide positioned in the housing (table 212), wherein the applicator assembly has:
a second preparation state in which the infusion head is adhered to the patient's skin and the holder remains positioned in the housing ([0040], Only removing the back of adhesive 112 of inner hub 104 prior to activation would only allow adhesive 112 to adhere to the patient’s skin.); and
a second application state in which the alignment guide mates with the infusion head (table 212, [0032], “arms 220 of the table 212 of the ballistic inserter 200 can pass through the outer hub 102 and contact and secure the inner hub 104”) to adhere the holder to the patient's skin at a predetermined location relative to the infusion head (FIG. 3A, FIG. 4, [0047], “the table 212 prevents rotation of the ballistic inserter 200 with respect to the outer hub 102”. Outer hub 102 connects to the surrounding member 106, so as table prevents rotation of outer hub 102, it also prevents rotation of the surrounding member 106, which makes placement easier.).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the applicator of the modified assembly of Michaud to include an alignment guide as taught by Constantineau in order to secure the infusion head ([0034]) and control the movement of the holder (0047]).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Michaud in view of Constantineau as applied to claim 1 above, and further in view of Krag et al. (United States Patent No. US 9,399,094 B2; herein, Krag).
Regarding claim 4, in the modified assembly of Michaud, Michaud does not disclose wherein the applicator assembly has: an application state in which the holder contacts the patient's skin and the injection device of the infusion head is retracted into the housing above the holder; and an insertion state in which the infusion head is aligned with the holder for mutual contact with the patient's skin.
However, Krag teaches wherein the applicator assembly has:
an application state (Fig. 7) in which the holder contacts the patient's skin and the injection device of the infusion head is retracted into the housing above the holder (cannula 951 is retracted inside housing 212 while the entire patch unit 200 is attached to the skin); and
an insertion state (Fig. 8) in which the infusion head is aligned with the holder for mutual contact with the patient's skin (both the cannula 951 and patch unit 200 are in contact with the skin).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified assembly disclosed by Michaud to define the application and insertion states as shown in Krag in order to allow the user the time to adhere the holder to the patient’s skin (col. 10 lines 65-67) prior to insertion of the infusion head (col. 11 lines 14-17).
Claims 5, 8, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Michaud in view of Constantineau as applied to claim 1 above, and further in view of Hanson et al. (United States Patent Application Publication No. US 2015/0190588 A1; herein, Hanson).
Regarding claim 5, in the modified assembly of Michaud, Michaud discloses wherein the injection device is a cannula (cannula 188).
Michaud does not disclose the applicator assembly further comprises an introducer hub with an introducer needle that punctures the patient's skin for receipt of the cannula in the insertion state, wherein the applicator assembly has a retraction state in which the introducer needle retracts into the housing and the cannula remains in the patient's skin.
However, Hanson teaches the applicator assembly further comprises an introducer hub (hub 212) with an introducer needle (needle 214) that punctures the patient's skin for receipt of the cannula in the insertion state ([0066], needle 214 and cannula 234 inserted into the body of the user), wherein the applicator assembly has a retraction state in which the introducer needle retracts into the housing and the cannula remains in the patient's skin ([0066], “…activation of the insertion mechanism…sequentially retracts the needle 214 from the second position to a third position…while maintaining the cannula 234 in fluid communication with the body of the user). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified assembly disclosed by Michaud to include a retractable introducer needle that punctures the patient’s skin for receipt of the cannula as taught by Hanson in order that a fluid pathway from the pump to the body of the user through the cannula is opened and fluid may begin to pass-through the cannula ([0066]).
Regarding claim 8, in the modified assembly of Michaud, Michaud does not disclose a safety lock having: a locked state that prevents movement of the actuator; and an unlocked state that permits movement of the actuator to move the injection device.
However, Hanson discloses a safety lock (on-body sensor 24) having:
a locked state that prevents movement of the actuator ([0040], activation mechanism cannot be engaged unless displacement of the on-body sensor 24 occurs); and
an unlocked state that permits movement of the actuator to move the injection device ([0040], activation mechanism cannot be engaged unless displacement of the on-body sensor 24 occurs).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified assembly disclosed by Michaud to include a safety lock and establish clear parameters for locked and unlocked states as taught by Hanson in order to prevent premature activation of the applicator’s insertion mechanism ([0040]).
Regarding claim 9, in the modified assembly of Michaud, Michaud does not disclose the safety lock includes a contact tab that extends beneath the housing in the locked state and retracts into the housing upon contact with the patient's skin in the unlocked state.
However, Hanson teaches the safety lock includes a contact tab (FIG. 1C, on-body sensor 24) that extends beneath the housing in the locked state and retracts into the housing upon contact with the patient's skin in the unlocked state (FIG. 1C, [0040], activation mechanism cannot be engaged unless displacement of the on-body sensor 24 occurs). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified assembly disclosed by Michaud to include a contact tab as part of the safety lock and establish clear parameters for locked and unlocked states as taught by Hanson in order to prevent premature activation of the applicator’s insertion mechanism ([0040]).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Michaud in view of Constantineau as applied to claim 1 above, and further in view of Gorman et al. (United States Patent Application Publication No. US 2004/0116866 A1; herein, Gorman).
Regarding claim 7, in the modified assembly of Michaud, Michaud does not disclose the housing surrounds the first adhesive pad of the infusion head and the second adhesive pad of the holder.
However, Gorman teaches the housing surrounds the first adhesive pad of the infusion head and the second adhesive pad of the holder (Fig. 4, adhesive layers 114, 116 are covered by housing 12 and totally surrounded by carrier 102). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified housing taught by Constantineau of the assembly disclosed by Michaud to encapsulate the adhesive pads as taught by Gorman in order that the first and second adhesive pads have less adhesive coverage of the patient's skin, making for easier removal ([0108]).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Michaud in view of Constantineau as applied to claim 1 above, and further in view of Chong et al. (United States Patent Application Publication No. US 2009/0198191 A1; herein, Chong).
Regarding claim 10, in the modified assembly of Michaud, Michaud does not disclose a carriage coupled to the actuator and having: a first state in which the carriage cooperates with the holder to prevent release of the holder from the housing; and a second state in which the carriage disengages the holder to permit release of the holder from the housing.
However, Chong teaches a carriage coupled to the actuator (carriage 782 attached to cam member 750) and having:
a first state in which the carriage cooperates with the holder to prevent release of the holder from the housing (FIG. 14); and
a second state in which the carriage disengages the holder to permit release of the holder from the housing (FIG. 15).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified actuator taught by Constantineau of the assembly disclosed by Michaud to include a carriage as taught by Chong in order that the device have controlled release under load ([0137]-[0138]), as it is known in the art that carriage mechanisms play a key role in the consistency of an injectable device’s release motion.
Claims 11 is rejected under 35 U.S.C. 103 as being unpatentable over Michaud in view of Constantineau and Chong as applied to claim 10 above, and further in view of Hanson.
Regarding claim 11, in the modified device of Michaud, Michaud does not disclose a safety lock having: a locked state that locks the carriage in the first state; and an unlocked state that permits movement of the carriage to the second state.
However, Hanson teaches a safety lock (on-body sensor 24) having:
a locked state that locks the carriage in the first state ([0040], activation mechanism cannot be engaged unless displacement of the on-body sensor 24 occurs); and
an unlocked state that permits movement of the carriage to the second state ([0040], activation mechanism cannot be engaged unless displacement of the on-body sensor 24 occurs).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the carriage taught by Chong of the modified assembly disclosed by Michaud to include a safety lock and establish clear parameters for locked and unlocked states as taught by Hanson in order to prevent premature activation of the applicator’s insertion mechanism ([0040]).
Claims 12, 13, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Michaud, and further in view of Constantineau.
Regarding claim 12, Michaud discloses a drug infusion system (Figs. 4B/5B) comprising:
a drug delivery device (pump 102);
an infusion head (infusion site connector 148) having an injection device (cannula 188) and a first adhesive pad (infusion site patch 190);
a holder (retention frame 106) being configured to support the drug delivery device (Figs. 1C-1F, [0028], snap portion 115 of retention frame snaps into place when aligned with the recess 139 of pump); and
wherein the drug infusion system is configured to be used interchangeably in at least two different wear configurations including:
a tethered configuration (Figs. 5A/5B) in which…the infusion head in adhesive communication with the patient's skin (infusion site patch 190); and
a patch configuration (Figs. 4A/4B) in which…the infusion head and the holder in adhesive communication with the patient's skin (Fig. 11A-E).
Michaud does not explicitly disclose the holder having a second adhesive pad, an applicator assembly comprising: a housing configured to carry both the infusion head and the holder, the infusion head and the holder each being selectively releasable from the housing for adherence to a patient's skin; and an actuator coupled to the housing and configured to move the infusion head injection device from the housing into the patient's skin, the applicator assembly positions the infusion head in adhesive communication with the patient's skin while preventing adhesive communication between the holder and the patient's skin, and the applicator assembly positions the infusion head and the holder in adhesive communication with the patient's skin.
However, Constantineau teaches the holder having a second adhesive pad ([0040], “an adhesive covering backing…can be peeled off one or both of the skin adhesive layers 110 and 112 of the infusion set 100”; The two components that make contact with the skin, the surrounding member 106 which contains adhesive 110 and the inner hub 104 which contains adhesive 112, can have separate adhesive covering backings which can be independently removed.), an applicator assembly (FIG. 3A, ballistic inserter 200) comprising: a housing (lower inserter housing 204) configured to carry both the infusion head and the holder (FIG. 8, [0033], [0048], The lower inserter housing 204 comprises attachment arms with snaps 205 for securing the lower inserter housing 204 to the rail 122 of the outer hub 102 of infusion set 100), the infusion head and the holder each being selectively releasable from the housing for adherence to a patient's skin (FIG. 3A – FIG. 5, [0033], [0040], [0041], [0048], Both the inner hub 104 and surrounding member 106 have the independent ability to be released from the ballistic inserter and adhered to the skin.); and an actuator (button 202) coupled to the housing (FIG. 3A, [0034], “The button 202 is configured to slidably engage the lower inserter housing 204”) and configured to move the infusion head from the housing into the patient's skin ([0036]-[0037], specifically in [0040] “The user then presses downward on the inserter button 202, loading the spring 208, releasing the hammer 208 to strike the table 212, which moves the inner hub 104, placing the inner hub 104 of the infusion set at the infusion site and inserting the needle 108 into the skin surface of the infusion site.”), the applicator assembly positions the infusion head in adhesive communication with the patient's skin while preventing adhesive communication between the holder and the patient's skin, and the infusion head and the holder in adhesive communication with the patient's skin pad (FIG. 3A-B, [0040], “an adhesive covering backing…can be peeled off one or both of the skin adhesive layers 110 and 112 of the infusion set 100”; The two components that make contact with the skin, the surrounding member 106 which contains adhesive 110 and the inner hub 104 which contains adhesive 112, can have separate adhesive covering backings which can be independently removed. The adhesive covering backing would prevent adhesive communication with the patient’s skin.). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the drug infusion system disclosed by Michaud to be functional with the applicator assembly, including the housing and actuator taught by Constantineau in order to ensure proper alignment and positioning of the drug infusion system on a patient’s skin ([0052]). Further, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the drug infusion system as disclosed by Michaud to have two separate adhesive pads as taught by Constantineau in order to give the user the decision of peeling of one or both of the backings of the adhesive pads ([0040]).
Regarding claim 13, in the modified system of Michaud, Michaud discloses a tubing set (tubing 144) positioned in fluid communication between the drug delivery device and the infusion head in the tethered configuration (Figs. 5A/5B).
Regarding claim 16, in the modified system of Michaud, Michaud discloses the tubing set is stored in a closed-loop in the patch configuration with one end of the tubing set coupled to the other end of the tubing set (Fig. 10C, examiner interprets that when tubing is removed from pump connection, the ends of the flexible tubing may be configured together to form a closed-loop system).
Claims 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Michaud in view of Constantineau as applied to claim 13 above, and further in view of Wojcik (United States Patent Application Publication No. US 2008/0154205 A1).
Regarding claim 14, in the modified system of Michaud, Michaud does not disclose the drug delivery device includes a needle port; the infusion head includes a septum port; and the tubing set includes a septum port at one end and a needle port at the other end; wherein: in the tethered configuration, the needle port of the drug delivery device communicates with the septum port of the tubing set, and the needle port of the tubing set communicates with the septum port of the infusion head; and in the patch configuration, the needle port of the drug delivery device communicates with the septum port of the infusion head without the tubing set.
However, Wojcik teaches the drug delivery device includes a needle port (FIG. 8, insertion needle assembly 200 has cannula 133 and insertion needle 164); the infusion head includes a septum port (FIG. 5, cannula housing body 104 has stepped bore 130); and the tubing set includes a septum port at one end and a needle port at the other end (FIG. 12, tubing hub assembly 300 includes connection fitting 330 and tubing hub needle 304); wherein:
in the tethered configuration, the needle port of the drug delivery device communicates with the septum port of the tubing set, and the needle port of the tubing set communicates with the septum port of the infusion head (FIG. 12, [0068]); and
in the patch configuration, the needle port of the drug delivery device communicates with the septum port of the infusion head without the tubing set (FIG. 1, insertion needle assembly 200 fits right into cannula housing body 104).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified drug infusion system as disclosed by Michaud to incorporate a needle port, a septum port, and a tubing set with both a needle and a septum port as taught by Wojcik in order to provide uninterrupted fluid flow communication whether in the patch or tethered configuration ([0033],[0078]). By using the same connections with or without the tubing set, a user can easily modify the modular device when swapping configurations.
Regarding claim 15, in the modified system of Michaud, Michaud does not disclose the drug delivery device includes a male connector; the infusion head includes a female connector; and the tubing set includes a female connector at one end and a male connector at the other end; wherein: in the tethered configuration, the male connector of the drug delivery device couples to the female connector of the tubing set, and the male connector of the tubing set couples to the female connector of the infusion head; and in the patch configuration, the male connector of the drug delivery device couples to the female connector of the infusion head without the tubing set.
However, Wojcik teaches the drug delivery device includes a male connector (FIG. 8, insertion needle assembly 200 has cannula 133 and insertion needle 164); the infusion head includes a female connector (FIG. 5, cannula housing body 104 has stepped bore 130); and the tubing set includes a female connector at one end and a male connector at the other end (FIG. 12, tubing hub assembly 300 includes connection fitting 330 and tubing hub needle 304); wherein:
in the tethered configuration, the male connector of the drug delivery device couples to the female connector of the tubing set, and the male connector of the tubing set couples to the female connector of the infusion head (FIG. 12, [0068]); and
in the patch configuration, the male connector of the drug delivery device couples to the female connector of the infusion head without the tubing set (FIG. 1, insertion needle assembly 200 fits right into cannula housing body 104).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified drug infusion system disclosed by Michaud to incorporate a male connector, a female connector, and a tubing set with both a male and female connector as taught by Wojcik in order to provide uninterrupted fluid flow communication whether in the patch or tethered configuration ([0033],[0078]). By using the same connections with or without the tubing set, a user can easily modify the modular device when swapping configurations.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Michaud in view of Gilbert as applied to claim 13 above, and further in view of Destefano (United States Patent Application Publication No. US 2018/0021508 A1).
Regarding claim 17, in the modified system of Michaud, Michaud does not disclose the applicator assembly further includes an alignment guide configured to adjust the drug infusion system from the tethered configuration to the patch configuration, the applicator assembly mating the alignment guide with the infusion head while positioning the holder in adhesive communication with the patient's skin.
However, Constantineau teaches disclose the applicator assembly further includes an alignment guide (table 212) configured to adjust the drug infusion system from the tethered configuration to the patch configuration, the applicator assembly mating the alignment guide with the infusion head while positioning the holder in adhesive communication with the patient's skin ([0032], “arms 220 of the table 212 of the ballistic inserter 200 can pass through the outer hub 102 and contact and secure the inner hub 104”; FIG. 3A, FIG. 4, [0047], “the table 212 prevents rotation of the ballistic inserter 200 with respect to the outer hub 102”. Outer hub 102 connects to the surrounding member 106, so as table prevents rotation of outer hub 102, it also prevents rotation of the surrounding member 106, which makes positioning easier.). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified drug infusion system disclosed by Michaud to include an alignment guide as taught by Constantineau in order to secure the infusion head ([0034]) and control the movement of the holder (0047]), regardless of configuration.
Response to Arguments
Applicant’s arguments, see pages 7-9 of Applicant’s Remarks filed 07/27/206, with respect to claims 1 and 12 have been considered but are moot because the arguments do not apply in view of the new grounds of rejection. The amended limitation “the infusion head and the holder each being selectively releasable from the housing for adherence to a patient's skin” as being met by Constantineau.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Moberg et al. (United States Patent Application Publication No. US 2006/0253086 A1) is considered relevant prior art with regards to a delivery device capable of having a patch configuration and a tethered configuration.
Naftalovitz et al. (WO 2018/131046 A1) is considered relevant prior art with regards to a two-patch transfusion pump that is releasable from an injection port.
Applicant's amendment necessitated the new grounds 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 Evelyn A Thoman whose telephone number is (571)272-8496. The examiner can normally be reached Monday-Friday 8:00 a.m-4:30 p.m..
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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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/EVELYN A THOMAN/Patent Examiner, Art Unit 3783
/THEODORE J STIGELL/ Primary Examiner, Art Unit 3783
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