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 .
Claim Objections
Claims 2-12 are objected to because of the following informalities:
Regarding claims 2-12, “A patch-type drug infusion…” should be corrected to “The patch-type drug infusion…” for claim language consistency.
Regarding claim 7, “…which the connection ends…” should be corrected to “…which the plurality of connection ends…” for claim language consistency.
Appropriate correction is required.
Drawings
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 plurality of connection ends and plurality of compressed conductive springs, subject matter of claim 6,
the flexible circuit board, subject matter of claim 7, and
a connection end disposed inside the control structure, subject matter of claim 12, must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-5, 8, and 11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 7, and 10 of copending Application No. 18032808 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the only difference between claim 1 of the copending application and claim 1 of the instant application is the limitation of “…the control structure and the infusion structure are assembled with each other…”. The copending application recites first and second fastening portions that cooperate with each other and are fastened together. In order for the first and second fastening portions to be fastened, the control and infusion structures would necessarily be assembled. Claims 2-5, 8, and 11 of the instant application contain the same limitations of claims 2-5, 7, and 10 of the copending application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. PCT/CN2020/125031, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The prior filed PCT does not provide description of any electrical contacts. Accordingly, claims 1-12 are not entitled to the benefit of the prior application.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-4, 6, 8-11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Streit (WO 2020148581 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]).
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), and a plurality of compressed conductive springs are respectively electrically connected to the corresponding connection ends (“the contacts 224… are manufactured from a stamped-bent/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 8, Streit discloses all the limitations of claim 1. Streit further discloses the patch-type drug infusion device wherein the case includes an upper case and a lower case (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).
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).
Regarding claim 11, Streit discloses all the limitations of claim 8. Streit further discloses the patch-type drug infusion device wherein the lower case further includes an outward extending portion, and a block is provided on an outside of the outward extending portion (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; the protruding structure on base plate 241 may be interpreted as a block, which is seen provided on an outside of the outwardly extending potion of base plate 241, see annotated Fig. 4 below in which the block is annotated as “Block”).
PNG
media_image1.png
614
489
media_image1.png
Greyscale
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.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Streit (WO 2020148581 A1) as applied to claim 1 above, 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) as applied to claim 6 above, 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) as applied to claim 1 above, 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 an other 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’.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Garai (US-20200337642-A1), Yodfat (US-20180264192-A1), Flaherty (US-20020169439-A1), Smith (US-20190015585-A1), Smith ‘907 (US-20120184907-A1), Streit ‘044 (US-20200086044-A1).
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.
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, 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MARTIN A RADOMSKI/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783