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 5/6/2026 has been entered. Claims 1-7, 9-10, and 12 are pending in the application. Applicant’s amendments to the Specification, Drawings, and Claims have overcome each and every objection previously set forth in the Non-Final Office Action mailed 2/6/2026.
Terminal Disclaimer
The terminal disclaimer filed on 5/6/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of any patent granted on Application Number 18032808 has been reviewed and is accepted. The terminal disclaimer has been recorded.
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(s) 1-4, 6, and 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Streit (WO 2020148581 A1), in view of Michaud (US 20160339172 A1).
Regarding claim 1, Streit discloses a patch-type drug infusion device ([0004]), comprising: a control structure provided with multiple first fastening portions and first electrical contacts exposed on a surface of the control structure (pump module 100/100’ provided with connection structure 110, which includes bayonet guide grooves 111, which includes corners 111a and ends 11b, which may be interpreted as multiple first fastening portions, [0041] and [0047] & Fig. 2a-2c and 6; pump module 100/100’ also includes snap tooth 142 which may be interpreted as another first fastening portion, [0041] & Fig. 3a; module 100/100’ includes contact arrangement 120/120’ comprising several electrical contacts 121/pins 121’, which are exposed on a surface of module 100/100’, see [0043] and [0047] & Fig. 3a and 6); and
an infusion structure including a case, with multiple second electrical contacts exposed on a surface of the case (reservoir module 200 including a housing (see [0076] & Fig. 4, reference numeral 240) and a base plate 241, which are being interpreted as a case, with complementary contact arrangement 220, which includes contact tongues 221, exposed on a surface of housing 240, [0042]-[0043] and [0076] & Fig. 1 and 3a-4) and second fastening portions that cooperate with the first fastening portions, when the control structure and the infusion structure are assembled with each other (connection structure 210 includes opening 212 and guide cams 211, which may be interpreted as multiple second fastening portions, [0041] & Fig. 1 and 3a-3b; cams 211 are configured to be inserted into guide groove 111, [0041] & Fig. 1a-2c; module 200 also includes snap recess 242 which may be interpreted as another second fastening portion configured to cooperate with tooth 142, [0041] & Fig. 3b),
the first fastening portions and the second fastening portions are fastened ([0041] & Figs. 2a-2c), the first electrical contacts and the corresponding second electrical contacts press against each other, thereby electrically connecting the control structure and the infusion structure ([0043] and [0047] & Fig. 2a-2c and 6-8a; “Pump module 100 and reservoir module 200 are connected not only mechanically but also electrically when the bayonet connection is closed. This is achieved via the contact arrangement 120 of the pump module and the complementary contact arrangement 220 of the reservoir module 200.”, [0043]; “…the reservoir module for the second embodiment can also be designed… identically to the first embodiment, so that only one socket receives all contact pins.”, [0047]), wherein the case includes an upper case and a lower case, and the lower case further includes an outward extending portion (housing 240 is being interpreted as an upper case and base plate 241 is being interpreted as a lower case, [0041] and [0076] & Fig. 4; base plat 241 includes an outwardly extending portion that comes to lie parallel with the base plate of housing 140 of module 100/100’, [0041] & Fig. 3a-4).
However, Streit fails to explicitly disclose the lower case further includes an outward extending portion and a pressing portion, wherein a block is provided on an outside of the outward extending portion, and the pressing portion is vertically connected to the block, wherein when the pressing portion is pressed, a blocking of the control structure by the block is released.
However, Michaud teaches a patch-type drug infusion device (abstract) comprising the lower case (attachment potion 104 and retention frame 106, Fig. 1A-1F) further includes an outward extending portion and a pressing portion (frame 106 and tab(s) 136, which can be depressed, [0028] & Fig. 1A-1F), wherein a block is provided on an outside of the outward extending portion (snap portion 115 provided on an outer surface of frame 106, [0028] & Fig. 1A-1F), and the pressing portion is vertically connected to the block, wherein when the pressing portion is pressed, a blocking of the control structure by the block is released (tab 136 is vertically connected to snap portion 115 such that when tab 136 is depressed, snap portion 115 withdraws from recess 139 in cartridge 116, allowing removal of cartridge 116, [0028] and [0033] & Fig. 1A-1F and 3C).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the device of Streit with Michaud to include a pressing portion, wherein a block is provided on an outside of the outward extending portion, and the pressing portion is vertically connected to the block, wherein when the pressing portion is pressed, a blocking of the control structure by the block is released, since such a modification would provide structure to securely connect the lower case to the control structure and would yield predictable results pertaining to component securement of a patch-type infusion device ([0028] and [0033] of Michaud).
As modified, base plate 241 of Streit would extend similarly to attachment portion 104 and frame 106 and include tab 136 and snap portion 115 of Michaud. Pump module 100/100’ of Streit would include recess 139 of Michaud.
Regarding claim 2, Streit discloses all the limitations of claim 1. Streit further discloses the patch-type drug infusion device wherein the first fastening portions and the second fastening portions include hooks, blocks, holes, or slots that cooperate with each other (snap tooth 142 and snap recess 242 can be interpreted as a hook and a slot/hole, [0041] & Fig. 3a-3b and 4; cams 211 and guide grooves 111 can be interpreted as blocks and slots, [0041] & Fig. 1-2c and 3b).
Regarding claims 3-4, Streit discloses all the limitations of claim 1. Streit further discloses the patch-type drug infusion device wherein one of the second electrical contacts is an elastic conductive member, wherein the elastic conductive member includes a conductive spring (“The contact tongues 221 are preferably designed to be spring-loaded, for example made from a metallic stamped and bent part… The spring-like design of the contact tongues 221 has the further advantage that it can absorb the axial movement superimposed on the rotation mentioned above and compensate for it during contacting.”, [0043] & Fig. 3b-4).
Regarding claim 6, Streit discloses all the limitations of claim 1. Streit further discloses the patch-type drug infusion device wherein a plurality of connection ends are provided in the infusion structure (the ends of contacts 224 are being interpreted as a plurality of connection ends, which are provided in module 200, [0045] & Fig. 5b-5c), the second electrical contacts are a plurality of compressed conductive springs, and the plurality of compressed conductive springs are respectively electrically connected to the corresponding connection ends (“The electronics board can be connected to the battery 230 or the contact arrangement 220 by way of example via the contacts 224 (in particular FIGS. 5b and 5c)… the contact tongues 221, the contacts 224…. are produced from a stamped-bending / plastic hybrid component, in particular from a component consisting of a metallic stamped-bent part overmolded with an electrically insulating plastic.”, [0045]; a metallic stamped and bent part is disclosed as being designed to be “spring-loaded” in [0043]; contacts 224, not including their ends, can be interpreted as a plurality of compressed conductive springs, [0045] & Fig. 5b).
Regarding claim 9, Streit discloses all the limitations of claim 8. Streit further discloses the patch-type drug infusion device wherein a bottom of the upper case includes a convex portion on which the second electrical contacts are disposed (as seen in Figure 4, a bottom of housing 240 includes a socket 222 on which contact arrangement 220 is disposed, see Fig. 4 & [0043]; socket 222 extends and is rounded outward, or convex, see Fig. 1 and 3b-4).
Regarding claim 10, Streit discloses all the limitations of claim 9. Streit further discloses the patch-type drug infusion device wherein a concave that fits the convex portion is provided on the control structure, and the first electrical contacts are provided in the concave (module 100/100’ includes a hollowed, arched in, or concave, portion, in which contact arrangement 120/120’ is disposed, that is configured to fit socket 222, [0043] and [0047] & Fig. 1-3a and 6).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Streit (WO 2020148581 A1), in view of Michaud (US 20160339172 A1), and further in view of Hanson (US 20190282756 A1).
Regarding claim 5, Streit discloses all the limitations of claim 1. Streit further discloses the patch-type drug infusion device wherein one of the first electrical contacts is a rigid pin while one of the second electrical contacts is a conductive spring (contact arrangement 120’ includes pins 121’, [0047] & Fig. 6; “The contact tongues 221 are preferably designed to be spring-loaded, for example made from a metallic stamped and bent part.”, [0043] & Fig. 3b-4).
a groove, within which a sealing element is provided, is disposed around an area where the second electrical contacts are disposed (“the contact arrangement 220 of the reservoir module 200 includes a socket 222 in which the contact tongues 221 are arranged (Figures 3b and 4). A sealing lip 223 is arranged at the edge of the socket 222, which, when the bayonet connection is closed, serves to prevent liquid from penetrating through the contact arrangement into the reservoir module 200”, [0043] & Fig. 3b).
However, Streit fails to explicitly disclose a metal pin. However, Hanson teaches a patch-type drug infusion device (abstract, [0109], [0140]-[0141] & Fig. 1-3) wherein one of the first electrical contacts is a rigid metal pin (“…suitable electronics may be connected to the first interactive element 104 and/or the second interactive element 106 to provide a controlled power signal to selectively activate or otherwise control one or more of the first interactive element 104 and the second interactive element 106 and/or other components as described in the disclosure.”, [0153]; “In such embodiments, the one or more of the interactive elements may be made of a suitably rigid material, such as, but not limited to, metal...”, [0174] and [0209]).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the pin of Streit with Hanson to include the pin being metal since Hanson teaches such a material to be an art effective material for an electronically interactive member capable of electronically connecting device housings (see [0153], [0164], and [0209] of Hanson).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Streit (WO 2020148581 A1), in view of Michaud (US 20160339172 A1), and further in view of Jäger (US 20190117256 A1).
Regarding claim 7, Streit discloses all the limitations of claim 6. Streit further discloses the patch-type drug infusion device wherein a circuit board on which the connection ends are disposed is further provided in the infusion structure (electronics board 250 is provided in module 200, [0045] & Fig. 5a-5c; the ends of contacts 224 are electrically connected to board 250, [0043]).
However, Streit fails to explicitly disclose a flexible circuit board. However, Jäger teaches a patch-type drug infusion device (abstract, [0050], and [0071]) with a flexible circuit board (patch 172 of medical device 108 comprises a circuit board 207, [0208] & Fig. 2A; “The electronics unit may comprise at least one interconnect device, preferably a printed circuit board, more preferably a flexible printed circuit board.”, [0061]).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the circuit board of Streit with Jäger to include a flexible circuit board since Jäger teaches a flexible circuit board to be an art effective equivalent to a circuit board in a patch-type drug infusion device configured to interconnect components and comprising electrical contacts (see [0061], [0198], and [0208] of Jäger)
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Streit (WO 2020148581 A1), in view of Michaud (US 20160339172 A1), and further in view of Peterson (US 20160058474 A1).
Regarding claim 12, Streit discloses all the limitations of claim 1. Streit further discloses the patch-type drug infusion device wherein one end of the first electrical contact is connected to a connection end disposed inside the control structure (an end of pins 121’ are disposed inside module 100’, see Fig. 7; the ends of pins 121’ can be seen connected to a structure inside module 100’, see Fig. 7 and 8a; the structure holding pins 121’, clearly illustrated in Figures 7 and 8a, is being interpreted as a connection end) while another end of the first electrical contact is exposed on the surface of the control structure (the second ends of pins 121’ are exposed on the surface of module 100’, see Figs. 6-8a), and a rest part of the first electrical contact is tightly embedded in a housing of the control structure (the remaining portions of pins 121’ are embedded in housing 140 and are disclosed as fixed, [0047] & see Figs. 6-8a).
Streit further discloses that “In an advantageous variant, the pump module further comprises a secondary energy source and/or storage, in particular a secondary cell or a capacity which can absorb and release electrical energy.” ([0016) and “Here, two contacts serve for the energy supply, whereby electrical energy is transferred from the reservoir module to the pump module. The two other modules can then be used in particular for signal transmission, especially for transmitting information from the reservoir module to the pump module and for transmitting control signals from the pump module to the reservoir module.”, ([0022]). The end of pins 121’ disposed in module 100’ would necessarily be electrically connected to a secondary energy source and/or storage to absorb electrical energy and perform signal transmission.
However, Streit fails to explicitly disclose the patch-type drug infusion device wherein one end of the first electrical contact is electrically connected to a connection end disposed inside the control structure.
However, Peterson teaches a patch-type drug infusion device (abstract and [0172] & Fig. 42) wherein one end of the first electrical contact is electrically connected to a connection end disposed inside the control structure (the first end of electrical connectors 708 are electrically connected to a sensor deployment assembly portion 710 and electronic circuit board 702 disposed inside of cover assembly 850, [0166], [0168], [0171], and [0175] & Fig. 44-46).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the device of Streit with Peterson to include one end of the first electrical contact electrically connected to a connection end disposed inside the control structure since such a configuration is taught by Peterson to be an art effective configuration for electronic connection between electronic components in a control assembly and electronic contacts configured to electrically couple to electrical coupling elements (see [0170]-[0171] and [0175] of Peterson).
As modified, the structure holding pins 121’ of Streit would be modified to function like electric circuit board 702 of Peterson, serving the necessary function of providing electrical connection between a secondary energy source and/or storage provided in module 100’ and pins 121’.
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Cook (US 20190351134 A1) teaches a patch pump 100 with an attachment portion 104 and frame 106 including inner wings 134 and outer wings 136 configured to be pressed. Inner wings 134 snap into corresponding recess 138 on pump 102 to facilitate connection (see [0024] & Fig. 1A-1F).
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 MARTIN ADAM RADOMSKI whose telephone number is (571)272-2703. The examiner can normally be reached Monday-Friday: 7:30-4:30 CT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARTIN A RADOMSKI/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783
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