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 Amendments filed 07/16/2026 have been entered.
Claims 1-14, 20 and 21 have thereby been amended.
Claims 18 and 19 have been cancelled.
Claims 1-14, 20 and 21 are being examined in this office action.
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.
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 1-5, 18 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Diaz (US 20020120236) in view of Harris (US 20200289745) in further view of Yodfat (US 8696629).
Regarding claim 1, Diaz a drug infusion device, comprising: an infusion mechanism module (Fig. 1A: 10), wherein the infusion mechanism module includes an upper case (Fig. 2B: 22), a lower case (Fig. 2A: 18), and a frame (Fig. 2A: 20 and 26 with inner components 47, 42, 43 and 52), the upper case is provided with upper cases engaging portions (Fig. 2B: screw holes and lower clip engagements on 22), the lower case is provided with lower case engaging portions (Fig. 2A: screw holes and clip engagements on 18), the frame is provided with first frame engaging portions engaged with the upper case engaging portions and the lower case engaging portions (Fig. 2A: screw holes that engage with screw holes of both 18 and 22 when screws 23 are inserted; para. [0066], sentence 3); further provided with a circuit board (Fig. 4: 118; para. [0139]), the circuit board is provided with a plurality of specific connection ends (Fig. 4: connection ends of 118 which connect to the coupled 174 display, 254 sensor, and detector 180); the frame is provided with electrical connection terminals of specific components and electrically connected the connection ends on the circuit board to form an internal circuit conduction of the infusion mechanism module (Fig. 2A: 47 and additional connection terminals which connect 118 to 42; para. [0159], sentences 1-5); a control mechanism module (Fig. 25: 240), electrically connected with the infusion mechanism module to regulate drug infusion (para. [0138]); and attaching the infusion mechanism module and the control mechanism module to a patient (para. [0126], sentence 1). However, Diaz fails to disclose that the circuit board is located on the lower case, or that the device is a skin patch and has an adhesive patch for attaching to the skin of the patient, or that the control mechanism has a separate housing detachable from the lower case of the infusion mechanism.
Harris teaches an analogous drug infusion device that is a skin patch with an adhesive patch for attaching the infusion mechanism module and the control mechanism module to a skin surface (para. [0024], sentences 5-7), and in which the lower case is further provided with a circuit board (Fig. 3: lower case 15 is provided with circuit board 88). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the bottom of the Diaz device by incorporating the adhesive patch taught by Harris to make the device a skin patch in order to make the device easily portable and eliminate the need for extra and bulky tubes and straps. It would have also been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Diaz device by rearranging the parts such that the circuit board is located on the lower case, as taught by Harris, instead of closer to the upper case as originally disclosed by Diaz, as this rearrangement of the circuit board position would not impede or change the function of the circuit board with the rest of the system, and may provide additionally stability to the circuit board components at the base of the device (see MPEP 2144.04 VI.C.).
Yodfat teaches an analogous trug infusion device wherein the infusion mechanism module (Fig. 2: 200; col. 10, lines 5-12) and the control mechanism module (Fig. 2: 100; col. 9, line 67 – col. 10, line 5) are detachable with each other (Fig. 5a), and the control mechanism module is reusable (col. 9, lines 62-64), the control mechanism module comprises a housing independent from the infusion mechanism module (Fig. 5a: casing of 100 separate from casing of 200), and the housing of the control mechanism module is detachably assembled to the lower case of the infusion mechanism module (Fig. 5a: casing of 100 attaches to the lower casing of 200). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Diaz-Harris device by incorporating the detachable structure of separate control unit and infusion unit housings, as taught by Yodfat, in order to allow for easy disassembly of the parts so that the control unit part may be reused while the infusion unit part is easily disposed of and replaced, and also such that the structural layout of the control components of the Diaz device can be preserved while simply rearranged into its own housing attached to the side of the rest of the device.
Regarding claim 2, Diaz in view of Harris in further view of Yodfat teaches the skin patch drug infusion device of claim 1, as described above, wherein the upper cases engaging portions include at least an upper case first engaging portion and an upper case second engaging portion (Diaz: Fig. 2B: screw holes being the first engaging portion, and lower clip engagements on 22 being the second engaging portion), the lower case engaging portions include at least a lower case first engaging portion and a lower case second engaging portion (Diaz: Fig. 2A: screw holes being the first engaging portion, and clip engagements on 18 being the second engaging portion).
Regarding claim 3, Diaz in view of Harris in further view of Yodfat teaches the skin patch drug infusion device of claim 2, as described above, wherein the upper case first engaging portion and the lower case first engaging portion are engaged with one of the first frame engaging portions on the frame, to form a longitudinal engaging of the frame, the upper case and the lower case (Diaz: longitudinal engagement of 18, 20 and 22 formed by screw holes of both 18 and 22 when screws 23 are inserted; para. [0066], sentence 3).
Regarding claim 4, Diaz in view of Harris in further view of Yodfat teaches the skin patch drug infusion device of claim 2, as described above, wherein the upper case second engaging portion is engaged with the lower case second engaging portion (Diaz: Fig. 2B: second engaging portion of upper case couples with second engaging portion of lower case), the frame is located on one side of the upper case second engaging portion and the lower case second engaging portion to form a lateral engaging and positioning of the frame, the upper case and the lower case (Diaz: Fig. 2B: the frame portions are only located on one side of the second engaging portion of upper case and second engaging portion of lower case, being located behind it, such that when assembled the lateral engagements and positionings of the upper and lower cases and frame are all fixed).
Regarding claim 5, Diaz in view of Harris in further view of Yodfat teaches the skin patch drug infusion device of claim 4, as described above, wherein the frame is provided with a reservoir (Diaz: Fig. 2A: reservoir 24 that fits into the frame between 20 and 26), a side of the frame is provided with a plurality of second frame engaging portions (Diaz: Fig. 2A: the ends of frame portions 26 that interconnect), and a plurality of reservoir engaging portions are provided on an outer side of the reservoir to engage with the second frame engaging portions (Diaz: Fig. 2A: the connectors at the open ends of 24, which engage at the second frame engaging portions when assembled).
Claims 6-13 are rejected under 35 U.S.C. 103 as being unpatentable over Diaz (US 20020120236) in view of Harris (US 20200289745) in further view of Yodfat (US 8696629) in further view of Hayakawa (US 20190111224).
Regarding claim 6, Diaz in view of Harris in further view of Yodfat teaches the skin patch drug infusion device of claim 1, as described above, wherein a driving wheel assembly (Diaz: Fig. 2A: 52) and a double-row battery (Diaz: Fig. 2A: 43/45) are arranged on a left side of the frame (Diaz: Fig. 2A: 52 and 43/45 arranged on the left half), however, Diaz-Harris fails to teach that two batteries are located on either side of the driving wheel assembly.
Hayakawa teaches an analogous portable pumping system, in which the double-row battery is arranged on both sides of the driving wheel assembly (Figs. 2 and 4: batteries 12a and 12b are each located on either side of driving assembly 31). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have rearranged the batteries of the Diaz-Harris device by placing them on either side of the driving wheel assembly, as taught by Hayakawa, as this arrangement would not change the function of the batteries or their delivered power to the driving wheel assembly (see MPEP 2144.04 VI.C.).
Regarding claim 7, Diaz in view of Harris in further view of Yodfat in further view of Hayakawa teaches the skin patch drug infusion device of claim 6, as described above, wherein an elastic conductor is provided on the frame (Diaz: Fig. 2A: 47; para. [0069], last sentence), used for connecting the double-row battery and the connection ends on the circuit board (Diaz: para. [0069], last sentence & para. [0125], second-to-last sentence).
Regarding claim 8, Diaz in view of Harris in further view of Yodfat in further view of Hayakawa teaches the skin patch drug infusion device of claim 7, as described above, wherein the elastic conductor is in the shape of "L" (Diaz: Fig. 2A: first and third connectors 47 have right-angle “L” shape), and a hole is provided on the frame, the elastic conductor passes through the hole to form an electric connection between the double-row battery and the circuit board (Diaz: Figs. 2A-B: the hole of the frame provided within 20, between both 26 components, through which connectors 47 connect to 45 and 118).
Regarding claim 9, Diaz in view of Harris in further view of Yodfat in further view of Hayakawa teaches the skin patch drug infusion device of any one of claim 7, as described above, wherein the electrical connection terminals of the components are arranged on the left side of the frame (Diaz: Fig. 2A: 118 and associated connections arranged on the left half) and are directly connected to the connection ends on the circuit board (Diaz: Fig. 4: connection ends of 118 which connect to the coupled 174 display, 254 sensor, and detector 180).
Regarding claim 10, Diaz in view of Harris in further view of Hayakawa teaches the skin patch drug infusion device of claim 7, as described above, wherein the frame is provided with a positioning post to fixing the elastic conductor (Diaz: Fig. 2A: positioning posts on 20, through which 23 go in order to fix the frame to the rest of the housing, which thereby fixes 47 in place).
Regarding claim 11, Diaz in view of Harris in further view of Yodfat in further view of Hayakawa teaches the skin patch drug infusion device of claim 9, as described above, wherein the component includes a conductive platform (Diaz: Fig. 4: 180; para. [0105], sentence 1), and a conductive platform positioning post and a stopper are provided on the frame for fixing the conductive platform (Diaz: Fig. 2A: frame posts for screw holes and rims at 20 and 26 for fixing all elements in their secured positions, including 180).
Regarding claim 12, Diaz in view of Harris in further view of Yodfat in further view of Hayakawa teaches the skin patch drug infusion device of claim 9, as described above, wherein the components include a power unit (Diaz: Fig. 2A: power unit 43), and a plurality of positioning tables are provided on the frame to limit an arrangement of the power unit (Diaz: Fig. 2A: elements 47 and frame protrusions, flanges, and screws surrounding 43).
Regarding claim 13, Diaz in view of Harris in further view of Yodfat in further view of Hayakawa teaches the skin patch drug infusion device of claim 9, as described above, wherein the component includes a driving unit (Diaz: Fig. 3: 42 and 28), and a conductive retaining wall is provided on the frame (Diaz: Fig. 4: 180 provided on the frame portions; para. [0105], sentence 1) to limit a movement end point of the driving unit (Figs. 3 and 4: 180 provides an upper limit above the driving unit).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Diaz (US 20020120236) in view of Harris (US 20200289745) in further view of Yodfat (US 8696629) in further view of Hayakawa (US 20190111224) in further view of Burren (US 20200405951).
Regarding claim 14, Diaz in view of Harris in further view of Yodfat in further view of Hayakawa teaches the skin patch drug infusion device of claim 9, as described above, wherein the component includes a driving unit (Diaz: Fig. 3: 42 and 28), but fails to teach a conductive tower-spring on the frame.
Burren teaches an analogous wearable drug infusion device, wherein a conductive tower-spring is provided on the frame (Fig. 4: tower-springs 29 coupled to the frame), used for fixing and electrically connecting the connection ends on the circuit (para. [0107], second half of the paragraph). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Diaz-Harris device by incorporating the conductive tower-springs taught by Burren into the frame as conductive connections between the circuit elements, as taught by Burren, in order to maintain a strong contact due to the bias provided by the springs (Burren: para. [0107], second-to-last sentence).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Diaz (US 20020120236) in view of Harris (US 20200289745) in further view of Yodfat (US 8696629) in further view of Gibson (US 20190022306).
Regarding claim 20, Diaz in view of Harris in further view of Yodfat teaches the skin patch drug infusion device of claim 1, (interpreted as depending upon claim 1 as described above), wherein the control mechanism module (Diaz: Fig. 25: 240) is provided with a first physical component (Diaz: Fig. 4: 118 and 242; para. [0138]), but fails to teach an in-position detection module as part of the infusion mechanism module.
Gibson teaches an analogous wearable drug infusion device wherein the infusion mechanism module (Fig. 1A: 10) is provided with an in-position detection module (Fig. 1C: 24; para. [0299], sentences 2-6), the in-position detection module includes a second physical component (Fig. 1C: physical protrusion 24), and the second physical component is operatively electrically connected to the first physical component (Fig. 1B: control mechanism module first physical component 400) to generate an in-position detection signal (para. [0299]). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Diaz-Harris device by incorporating the in-position detection module (24) in connection with the control module, as taught by Gibson, in order to provide a sensor that only permits the infusion to operate when the device is properly fixed in position on the patient, such that error in the infusion of the drug is avoided (Gibson: para. [0299]).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Diaz (US 20020120236) in view of Harris (US 20200289745) in further view of Yodfat (US 8696629)in further view of Margairaz (US 20180133395) in further view of Cohen (US 20170361067).
Regarding claim 21, Diaz in view of Harris in further view of Yodfat teaches the skin patch drug infusion device of claim 1, as described above, but fails to explicitly teach that the adhesive patch (Harris: para. [0024], sentences 5-7) comprises a tape with paste and a protective film.
Margairaz teaches an analogous wearable drug infusion device wherein the adhesive patch comprises a tape (Figs. 31A-B: 3702; para. [0171], sentence 2) and a protective film (Fig. 31B: 3704; para. [0171], sentence 2), a first side of the tape is fixedly connected with the skin patch drug infusion device, and a second side opposite the first side of the tape is coated with a paste material (Fig. 31B: 3702, the first side of the tape coupled to 3701; para. [0171], sentence 2, the paste material being the glue/adhesive that creates the adhesion of the tape), the protective film is fixed around an outer edge of the first side of the tape (Fig. 31A: 3702 fixed to 3704), an outer edge of the protective film contour corresponds to the outer edge of the first side of the tape (Figs. 31A-B: edge of 3702 follows/corresponds to 3704). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Diaz-Harris device by incorporating the specific tape and film features of the adhesive patch, as taught by Margairaz, in order to improve the adhesion of the device to the skin around the entire perimeter. However, Margairaz and the Diaz-Harris-Margairaz combination fail to explicitly teach a rockwell harness levels of the tape and film.
Cohen teaches an analogous skin adhesive tape and film for medical device attachment, wherein a rockwell hardness of the protective film is higher than a rockwell hardness of the tape (para. [0050], the protective film being the firm layer which is harder, and the adhesive tape is less hard and pierceable). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Diaz-Harris-Margairaz device by incorporating the teaching of Cohen to make the tape less hard that the protective film, in order to have a softer tape that is comfortable on the skin and a protective film that is less prone to tearing.
Response to Arguments
Applicant’s arguments filed 07/16/2026 with regards to the prior art rejections have been fully considered but are considered moot in light of the new amendments and the new grounds of rejection for independent claim 1.
Independent claim 1 no longer solely relies upon Diaz in view of Harris to teach all limitations of the claim, but rather now relies upon Yodfat to teach the rearrangement of the aspects of the Diaz device into two separate housing units which are detachable from each other, as claimed in the newly added claim amendments.
For this reason, claims 1-14, 20 and 21 stand rejected in further view of Yodfat, as recited above.
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 KATERINA ANNA WITTLIFF whose telephone number is (703)756-4772. The examiner can normally be reached M-Th: 9-7ET.
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/K.A.W./Examiner, Art Unit 3783
/NATHAN R PRICE/Primary Examiner, Art Unit 3783
