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 03/03/2026 has been entered. Claims 1-14, 17 are pending in the application. Applicant's amendments to the claims have overcome every objection and 112(b) rejection previously set forth in the Non-final Office Action mailed 12/23/2025.
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.
Claims 1-12, 17 are rejected under 35 U.S.C. 103 as being unpatentable over Streit (US 2021/0338924) in view of Michaud (US 9,993,595).
Regarding Claim 1, Streit discloses a skin patch drug infusion device (1, Fig 1), comprising: an infusion mechanism module (200, Fig 1), wherein the infusion mechanism module includes an infusion module (291, 292, Fig 5c) and a circuit module (230, 250, Fig 5a-b), the circuit module includes: a circuit board (250, Fig 5a) or a three-dimensional circuit; a power supply (230, Fig 5b), for supplying power to the skin patch drug infusion device; an elastic conductor (224, 225, Fig 5b), provided with at least one protrusion (protrusion in 225 that contacts the battery, Best seen in Fig 5c), for electrically connecting the power supply to a connection end on the circuit board or the three-dimensional circuit (Para 0039-0040); a control mechanism module (100, Fig 1), electrically connected with the infusion mechanism module (Para 0037), wherein the infusion mechanism module and the control mechanism module are detachable with each other (See Figs 2a-c), and the control mechanism module is reusable (Para 0035).
Streit is silent regarding an adhesive patch, for attaching the infusion mechanism module and the control mechanism module to a skin surface, and wherein the infusion mechanism module comprises an outward extending portion, a block is provided outside the outward extending portion, the outward extending portion and the block form an engaging position, when the control mechanism module is pressed to the engaging position, the control mechanism module is limited by the block to prevent from detaching, wherein the outward extending portion is provided with a pressing portion for releasing the block, and an unlocking hole is disposed beside the block for providing a space to push the control mechanism module to separate from the infusion mechanism module when the pressing portion is pressed.
Michaud teaches an analogous a skin patch drug infusion device (102, Fig 1C), comprising: an infusion mechanism module (116, 106, Fig 1A) and a control mechanism module (118, Fig 1A); and an adhesive patch (108, Fig 1D), for attaching the infusion mechanism module and the control mechanism module to a skin surface (Col 7, lines 42-47), and wherein the infusion mechanism module comprises an outward extending portion (106, Fig 1A), a block (114, Fig 1C) is provided outside the outward extending portion, the outward extending portion and the block form an engaging position, when the control mechanism module is pressed to the engaging position, the control mechanism module is limited by the block to prevent from detaching (Col 4, lines 20-41), wherein the outward extending portion is provided with a pressing portion (136, Fig 1B) for releasing the block (Col 4, lines 38-41), and an unlocking hole (138, Fig 1D) is disposed beside the block for providing a space to push the control mechanism module to separate from the infusion mechanism module when the pressing portion is pressed (A user can use this recess to gain extra purchase on the control mechanism module when attempting to separate the two modules).
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 device to include an adhesive patch, outward extending portion, a block, pressing portion, and an unlocking hole as taught by Michaud in order to hold the device at a desired insertion location while being able to remove the pump from the insertion site for charging or servicing without having to reinsert the cannula upon reconnection of the pump to the retention frame (Col 4, lines 36-38; Col 7, lines 42-47; Col 7, lines 25-31).
Regarding Claim 2, the modified invention of Streit and Michaud discloses the elastic conductor includes a first elastic conductor (225, Fig 5b -Streit) connected with the power supply (230, Fig 5b -Streit) and a second elastic conductor (224, Fig 5b -Streit) connected with the connection end on the circuit board or the three-dimensional circuit (Para 0040 -Streit).
Regarding Claim 3, the modified invention of Streit and Michaud discloses the elastic conductor is a sheet metal (“metal press-bent part”, Para 0040 -Streit)
Regarding Claim 4, the modified invention of Streit and Michaud discloses the elastic conductor is integrated by the first elastic conductor (225, Fig 5b -Streit) and the second elastic conductor (224, Fig 5b -Streit) directly electrically connected or indirectly electrically connected with other conductive elements (Para 0040 -Streit; the conductors connect to conductive elements on circuit board).
Regarding Claim 5, the modified invention of Streit and Michaud discloses the elastic conductor is arranged in an "L" shape (See Fig 5c; “metal press-bent part” -Streit)
Regarding Claim 6, the modified invention of Streit and Michaud discloses the at least one protrusion (protrusion in 225 that contacts the battery, Best seen in Fig 5c -Streit) is provided on the first elastic conductor.
Regarding Claim 7, the modified invention of Streit and Michaud discloses the protrusion is a linear protrusion (protrusion in 225 that contacts the battery, Best seen in Fig 5c -Streit).
Regarding Claim 8, the modified invention of Streit and Michaud discloses an insulating member (“ spray-coated with an electrically insulating plastic”) is provided at a junction of the first elastic conductor and the second elastic conductor (Para 0040 -Streit).
Regarding Claim 9, the modified invention of Streit and Michaud discloses the infusion mechanism module further includes a frame (See annotated Fig 5a below).
Regarding Claim 10, the modified invention of Streit and Michaud discloses a positioning post is provided on the frame to fix the elastic conductor (See annotated Fig 5a below).
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Regarding Claim 11, the modified invention of Streit and Michaud discloses a boss is provided on the frame, located near the positioning post (See annotated Fig 5a below).
Regarding Claim 12, the modified invention of Streit and Michaud discloses the elastic conductor is at least one of a conductive spring (Para 0039-0040 -Streit), a conductive leaf spring, a conductive rubber and a conductive silica gel
Regarding Claim 17, the modified invention of Streit and Michaud discloses an insulating member (“ spray-coated with an electrically insulating plastic”) is provided at a junction of the first elastic conductor and the second elastic conductor (Para 0040 -Streit).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Streit (US 2021/0338924) in view of Michaud (US 9,993,595) and further in view of Estes (US 2010/0049164).
Regarding Claim 13, the modified invention of Streit and Michaud discloses all of the elements of the invention as discussed above, however, is silent regarding the circuit board is flexible
Estes teaches an analogous drug infusion device (10, Fig 1) comprising a circuit board (242, Fig 9) wherein the circuit board is flexible (Para 0064).
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 circuit board to be a flexible circuit board as Estes teaches that the form of the circuit board can be modified to be flexible, have multiple, boards, or have other configurations in order to meet specific operation criteria (Para 0064).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Streit (US 2021/0338924) in view of Michaud (US 9,993,595)and further in view of Uchiyam (US 2019/0217008).
Regarding Claim 14, the modified invention of Streit and Michaud discloses all of the elements of the invention as discussed above, however, is silent regarding the power supply is a double-row battery pack (144, Fig 5).
Uchiyam teaches an analogous skin patch drug infusion device (10, Fig 1) wherein the power supply is a double-row battery pack (Para 0076).
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 power supply to be a double-row battery pack as Uchiyam teaches that the number of batteries and connection method are not particularly limited as long as electric power is fed to each unit (Para 0076).
Response to Arguments
Applicant’s arguments filed 03/03/2026, on pages 9-13, regarding Streit failing to teach the amended claim limitations have been fully considered but are moot in view of the current rejection that relies on Michaud to teach the new limitations.
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 ANTARIUS S DANIEL whose telephone number is (571)272-8074. The examiner can normally be reached M-F 7:00am to 4:30pm EST.
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/ANTARIUS S DANIEL/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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