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 .
Election/Restrictions
Applicant’s election without traverse of Species 1 of Figs. 1-10c in the reply filed on 03/16/26 is acknowledged. Claims 1-16 are currently being examined in this office action.
Drawings
a) The drawings in Figs. 3a-b, 4a-c, 8a-8b, 9b, 9d are not of sufficient quality (very blurry and small scale) to permit examination. Accordingly, replacement drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to this Office action. The replacement sheet(s) should be labeled “Replacement Sheet” in the page header (as per 37 CFR 1.84(c)) so as not to obstruct any portion of the drawing figures. If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action.
Applicant is given a shortened statutory period of TWO (2) MONTHS to submit new drawings in compliance with 37 CFR 1.81. Extensions of time may be obtained under the provisions of 37 CFR 1.136(a) but in no case can any extension carry the date for reply to this letter beyond the maximum period of SIX MONTHS set by statute (35 U.S.C. 133). Failure to timely submit replacement drawing sheets will result in ABANDONMENT of the application.
b) The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the limitation “when the movable block is opened, the screw does not engage with the driving wheel assembly, and when the movable block is closed, the screw engages with the driving wheel assembly” in claim 1; the limitation “the frame is provided with an arc-shaped blocking member, when the movable block is located outside the arc-shaped blocking member, the movable block is opened, and when the movable block is located inside the arc-shaped blocking member, the movable block is closed” in claim 2; the limitation “a strip is arranged in the card slot” in claim 5; the limitation “the strip is abutted against the baffle to form a through hole for accommodating the screw” in claim 6; the limitation “... a movable block connecting rod, the movable block is movably connected with the driving wheel body through the movable block connecting rod” in claim 10 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Note: The Figs. 9a & 9c show that the movable block 182/183 is opened or closed with respect to the driving wheel 161 but do not show the screw being engaged nor disengaged with the driving wheel assembly. It is noted that the Figs 4b-4c show the driving wheel 124 & screw 135; however, these drawings are very blurry and in small scale, it is difficult for Examiner to find the connection in between the screw and the driving wheel assembly.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2-10 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In claim 2, the Figs. 9b & 9d (in blurry & in small-scale condition) show the arc-shaped blocking member 174 and the movable block 182 & 183. It appears to Examiner that both of Figs. 9b & 9d show that movable block 182 & 183 is located outside of the arc-shaped blocking member 174. Therefore, it is unclear to Examiner that how is the movable block being located outside the arc-shaped blocking member, the movable block being opened, and when the movable block being located inside the arc-shaped blocking member, the movable block being closed?
The original specification states on pages 5, 19-20 that “ FIG. 9a-FIG. 9d are schematic views of the movable block opened or closed according to an embodiment of the present invention, respectively.” However, there is no guidance to point out specifically that which figures (from 9a-9d) being designated for movable block in open condition, or movable block in closed condition.
Due to ambiguities in the drawings, the specification, and the claim, the Examiner has had to interpret multiple, conflicting potential directions, making it difficult to determine the intended scope of the invention. The application is requested to clarify this matter.
The claims 3-9 are being rejected due to their dependency.
In claims 5-6, the Fig. 8a shows a card slot 173. Although the claim states that a strip is arranged in the card slot. However, it is unclear to Examiner that how and where is strip being provided so that the strip being abutted against the baffle to form a through hole for accommodating the screw, as required in claims 5-6.
Due to ambiguities in the drawings, the specification, and the claim, the Examiner has had to interpret multiple, conflicting potential directions, making it difficult to determine the intended scope of the invention. The application is requested to clarify this matter.
The claim 7 is being rejected due to its dependency.
In claim 10, the marked-up Fig. 8a below show that the #181 is designed to a movable block connecting rod 181. It appears to the Examiner that the #181 looks like “a hole or opening”. For example: the Figs. 9a & 9c show that the movable block 182 & 183 but do not include a movable block connecting rod 181 nor the relationship in between the movable block, the driving wheel body. Therefore, it is unclear to Examiner that how is the movable block being movably connected with the driving wheel body through the movable block connecting rod, as required in the claim 10.
Due to ambiguities in the drawings, the specification, and the claim, the Examiner has had to interpret multiple, conflicting potential directions, making it difficult to determine the intended scope of the invention. The application is requested to clarify this matter.
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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.
Claims 1, 11-15 are rejected under 35 U.S.C. 103 as being unpatentable over Dilanni et al. (US 2005/0238507) in view of Clemente et al. (US 9,737,655).
Regarding claim 1, Dilanni discloses a drug infusion device (or a skin patch drug infusion device, as modified by Neta below), comprising:
an infusion mechanism module 230 & 250, wherein the infusion mechanism includes: a reservoir 230, used for accommodating a drug to be infused, a screw 252 and a piston 236 connected with the screw 252, wherein the screw 252 and the piston 236 are arranged inside the reservoir 230;
a driving wheel assembly 256, threadedly connected with the screw 252, wherein the driving wheel assembly 256 includes a driving wheel body 256 and a movable block 242, the driving wheel body 256 and the movable block 240 are operatively connected, see Figs. 2 & 11A, when the movable block 242 is opened (Figs. 11A & 12A), the screw 252 does not engage with the driving wheel assembly 256, see paras [0048], and when the movable block is closed, in Figs. 11B-12B, the screw 252 engages with the driving wheel assembly 256, also see paras [0048-0049];
a control mechanism module 290, electrically connected with the infusion mechanism module, para [0029];
It appears in the Fig. 1 in Dalanni that the infusion device includes adhesive patch and a protective film (or release liner). In case Applicant disagrees with the Examiner’s statement above, the infusion device in Fig. 1 can be modified as below.
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(Assuming) Dilanni does not disclose that an adhesive patch, for attaching the infusion mechanism module and the control mechanism module to a skin surface.
Clemente discloses a skin patch drug infusion device 100 comprising: a housing 12A/12B; an infusion mechanism module 90; a control mechanism module 80; wherein an adhesive patch 26 for attaching the infusion mechanism module and the control mechanism module to a skin surface, see Fig. 1A.
It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the device of Dilanni with providing adhesive patch being located under a housing of the infusion device, as taught by Clemente, in order to secure the infusion device to prevent dislodging.
Regarding claim 11, Dilanni in view of Clemente discloses all claimed subject matter as required. Dilanni further discloses that wherein the infusion mechanism module (i.e., reservoir, fluid passage mechanism 270) and the control mechanism module (i.e., battery 110, circuit board 290), fluid driving mechanism 250) are detachable to each other, and the control mechanism module is reusable, see Figs. 1-4 & 9-10. In addition, a person skilled in the art would recognize that the infusion mechanism module and the control mechanism module are being detachable and that considered as constructing a formerly integral structure in various elements involves only routine skill in the art.
Regarding claim 12, Dilanni in view of Clemente discloses all claimed subject matter as required. Dilanni further discloses that wherein the infusion mechanism module and the control mechanism module are disposed in one housing 100 & 202, with regarding to the limitation, i.e., discarded together after a single-use, as considered as intended use purpose.
Regarding claim 13, Dilanni in view of Clemente discloses all claimed subject matter as required. Dilanni further discloses that wherein the control mechanism module is provided with a plurality of first electrical 194a contacts exposed on a surface of the control mechanism module and the infusion mechanism module is provided with a plurality of second electrical contacts 268a/b electrically connected with the first electrical contacts, para [0039]. Note: the legs 268a/b are parts of the infusion mechanism.
Regarding claim 14, wherein the first electrical contacts 194a-b are rigid metal pins or elastic conductive members, or the second electrical contacts 268a/b are rigid metal pins or elastic conductive members, see Fig. 4.
Regarding claim 15, wherein the infusion mechanism module further includes a case/housing 202, the case is provided with an outward extending portion (at a rim portion of the housing 202, see Fig. 1), and a block/chassis 100 is provided on an outside of the outward extending portion, see Fig. 2.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Dilanni et al. (US 2005/0238507) in view of Clemente et al. (US 9,737,655) and further in view of Yavorsky et al. (US 11,439,352).
Regarding claim 16, Dilanni in view of Clermente discloses all claimed subject matter as required. Clemente discloses that wherein the adhesive patch 26 but does not disclose the adhesive patch as required in the claimed invention.
Yavorsky discloses an adhesive pad for attaching a medical device comprising: a tape 200, a protective film 206; a first/top side of the tap 200 is fixedly connected with a skin patch-insertion device 12 (temporary called as a skin patch drug infusion device 12), a second/bottom side opposite the first side of the tape is coated with a paster material, i.e. an adhesive layer 202; the protective film 206 is fixed around an outer edge of the first side of the tape 200, see Figs. 1-2, an outer edge of the protective film 206 contour corresponds to the outer edge of the first side of the tape 200.
It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the adhesive pad of the device of Dilanni in view of Clermente with including a tape and protective film, as taught by Yavorsky, in order to provide more stability for securing in between the drug device and the patient’s skin.
With aspect to the limitation, i.e., a Rockwell hardness of the protective film is higher than a Rockwell hardness of the tape, it is noted that the Rockwell hardness scale is determined based on the hardness of a material. In this case, Yavorsky discloses that the protective film 206 is composed of polycarbonate (PC), polyethylene terephthalate (PET), polyethylene terephthalate glycol-modified (PETG), polypropylene (PP), polymethyl methacrylate (PMMA), acrylonitrile butadiene styrene (ABS), etc. ... In the example of a biocompatible metal or metal alloy material, the shim 206 may be composed of a stainless steel, see col. 6, line 67-col. 7, lines 12. The backing layer 200 is composed of a polyester, polyurethane, nylon, cotton, etc., col. 6, lines 21-22. It is noted that the Rockwell hardness of polyethylene terephthalate (PET) is about 90-95HRM (as Applicant admits in 2nd-3rd paragraph, on page 21 of the original specification in the current application). Meanwhile, the tape 200 is composed very soft material, i.e., polyurethan, nylon, cotton (those similar products as listed in the last paragraph, on page 20 of the original specification in the current application). In other words, a Rockwell hardness of the protective film 206 is higher than a Rockwell hardness of the tape 200.
In addition, it would have been obvious to one having ordinary skill in the art before the effective filling date of the present invention was made to obtain the Rockwell hardness of the protective film being higher than a Rockwell hardness of the tape, since applicant has not disclosed that having the Rockwell hardness level in between the protective film and the tap solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designed. Furthermore, it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Examiner Notes
Examiner cites particular columns and line numbers in the references as applied to the claims above for the convenience of the applicant. Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUYNH-NHU HOANG VU whose telephone number is (571)272-3228. The examiner can normally be reached on M-F 7:30 am-4:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached on 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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/Quynh-Nhu H. Vu/
Quynh-Nhu H Vu
Primary Examiner, Art Unit 3783
Prosecution Insights