DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Priority
This application appears to be a division of Application No. 16/415,784 filed on 05/17/2019, which is a division of Application No. 13/984,029 filed on 11/15/2013, which is a U.S. National Stage Entry of PCT Application No. PCT/US12/00069, which claims provisional application No. 61/441,265 filed on 02/09/2011.
However, the provisional Application No. 61/441,265 does not include the elected embodiment Species III (figs. 11-18B). Only the PCT Application No. PCT/US12/00069 has that embodiment. Therefore, Examiner considers the effective filling date for this application and the elected embodiment to search is 02/08/2012.
Electrion/Restriction
Applicant's election with traverse of Group I (claims 1-20) and species III (figs. 11-18B) in the reply filed on 07/08/2026 is acknowledged. The traversal is on the ground(s) that due to overlap in subject matter between the identified claim groups, there would be no undue burden on the Examiner to examine all of the claims. For example, both groups of claims relate to an infusion device with push button release to insert a catheter an introducer needle into an infusion site, a flexible upper housing segment having a first shape when relaxed and a second shape when compressed, and the flexible upper housing travels substantially perpendicular a skin surface.
This is not found persuasive because Groups II and I are related as process and apparatus for its practice. Group I recites an infusion device comprising an infusion device housing, a catheter, a driver, an infusion device base with at least one adhesive layer, an introducer needle, a catheter septum, and a push button. Whereas Group II recites a method of placing an infusion device with an infusion device base, a button, a catheter, and an introducer needle. The method can be practiced without a driver and at least one adhesive layer. The prior art (without teaching a driver and at least one adhesive layer) that reads on the method claim would not be applicable for the apparatus claim.
The requirement is still deemed proper and is therefore made FINAL.
Claim(s) 1-7, 11-16, 18-24 is/are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected group and nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 07/08/2026.
Examiner notes:
Claims 1- 5 recites an infusion device comprising a push button configured to travel substantially perpendicular to said skin surface and press said catheter septum toward said skin surface and insert said introducer needle and said catheter into said skin surface, which is shown in figs. 1-5C.
Claims 6-7 recites an infusion device comprising a curved catheter path, which is shown in figs. 6-10E.
Claims 11-12 recites an infusion device comprising a rotating needle hub configured to rotate within said infusion device housing and press said introducer needle and said catheter into said skin surface, which is shown in figs. 19-27.
Claims 13-16 recites an infusion device comprising a coil spring disposed substantially parallel to said skin surface and having said introducer needle, catheter septum and catheter deposed in a center opening, which is shown in figs. 19-27.
Claims 18-20 recites an infusion device comprising a flexible catheter holder, which is shown in figs. 32-37.
Claims 21-24 recites a method of placing an infusion device.
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.
Claim(s) 8-10, 17-20 is/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.
Regarding claim 8, the phrase "a catheter" in line 3 renders the claim indefinite because it is unclear whether this limitation is the same or different from “a catheter” recited in claim 8 line 1.
Claims 9-10 are rejected by virtue of depending on claim 8.
Regarding claim 17, the phrase "a catheter" in line 3 renders the claim indefinite because it is unclear whether this limitation is the same or different from “a catheter” recited in claim 17 line 1.
Claims 18-20 are rejected by virtue of depending on claim 17.
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 pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
Claim(s) 8-10 and 17 is/are rejected under pre-AIA 35 U.S.C. 102(a) as being anticipated by Griffin (US 2008/0051738).
Regarding claim 8, Griffin discloses
An infusion device (device shown in figs. 2-3 with the embodiment shown in figs. 9-10), comprising an inserter (212, figs. 9-10) that can insert a catheter (cannula of 212 disclosed in par. 0105) into a skin surface (Examiner notes: see par. 0105 for the device 212 including a needle, a needle carriage, a cannula, a first septum, a bias member, and a second septum, similar to the needle 42 and the cannula 48 of figs. 4-6, and the device 212 including a needle, a needle carriage, a cannula, first and second septa, and a bias member similar to the needle 142 and the cannula 148 of figs. 7-8. See figs. 4-6 and 7-8 for cannulas 48 and 148 respectively.), comprising:
an infusion device housing (244, figs. 9-10. Examiner notes: the prior art specification does not disclose what element 244 is, however, the prior art specification discloses elements 44 and 144 being a housing structure of the embodiment of figs. 4-6 and the embodiment of figs. 7-8), comprising a catheter (cannula of 212 disclosed in par. 0105. See also figs. 4-6 for catheter 48 and figs. 7-8 for catheter 148) and a driver (250/251/suitable linkage structure, figs. 9-10 and par. 0107) for placing said catheter into a skin surface (see figs. 9-10 and pars. 0106-0109); and
an infusion device base (21, figs. 2-3), comprising at least one adhesive layer (adhesive layer disclosed in par. 0055) for releasably securing said infusion device base with said skin surface (par. 0055),
wherein said driver (250/251/suitable linkage structure, figs. 9-10 and par. 0107) comprises: a rotating cam ring (250) configured to rotate within said infusion device housing (see figs. 9-10 and pars. 0106-0109) and press said catheter into said skin surface (see figs. 9-10 and pars. 0106-0109).
Regarding claim 9, Griffin discloses
An infusion device as claimed in claim 8, further comprising: an introducer needle (242, figs. 9-10 and par. 0105), wherein said rotating cam ring (250) also presses said introducer needle into said skin surface (see figs. 9-10 and pars. 0106-0109).
Regarding claim 10, Griffin discloses
An infusion device as claimed in claim 9, wherein said rotating cam ring is configured to rotate within said infusion device housing and retract said introducer needle from said catheter (Examiner notes: see par. 0105 for the device 212 including a needle, a needle carriage, a cannula, a first septum, a bias member, and a second septum, similar to the needle 42, the cannula 48, and coil spring bias member 56 of figs. 4-6, and the device 212 including a needle, a needle carriage, a cannula, first and second septa, and a bias member similar to the needle 142, the cannula 148, and coil spring bias member 156 of figs. 7-8. See par. 0087 for the bias member 56 configured to return the needle 42 to the retracted position of the needle, leaving the needle carriage 46 and cannula 48 in the extended position, as shown in fig. 6. See par. 0099 for the bias member 156 configured to return the needle 142 to the retracted position, leaving the needle carriage 146 and cannula 148 in the extended position, as shown in fig. 8. See fig. 9 for the bias member of the device 212 in its relaxed position when cam 250 is in its first rotational position, and see fig. 10 for the bias member in its compressed position when cam 250 is in its second rotational position. Therefore, when cam 250 is rotated from its first rotational position to its second rotational position, the bias member is compressed; and when cam 250 is rotated from its second rotational position to its first rotational position, the bias member is expanded under the bias force of the spring, causing the return of the needle to its retracted position and leaving the needle carriage and the cannula in the extended position).
Regarding claim 17, Griffin discloses
An infusion device (device shown in figs. 2-3 with the embodiment shown in figs. 7-8), comprising an inserter (140, figs. 7-8) that can insert a catheter (148, figs. 7-8) into a skin surface (see figs. 7-8 and pars. 0091-0103), comprising:
an infusion device housing (144, figs. 7-8 and pars. 0092-0093), comprising a catheter (148) and a driver (159) for placing said catheter into a skin surface (figs. 7-8 and pars. 0091-0103); and
an infusion device base (21, figs. 2-3), comprising at least one adhesive layer (adhesive layer disclosed in par. 0055) for releasably securing said infusion device base with said skin surface (par. 0055),
wherein said driver (159) comprises:
a push button (159, par. 0094) configured to travel substantially parallel to said skin surface (see fig. 7 for the arrow 163 with respect to the base of the device / skin surface) and release said catheter and insert said catheter into said skin surface (figs. 7-8 and pars. 0091-0103).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO 892 form.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DUNG T ULSH whose telephone number is (571)272-9894. The examiner can normally be reached Monday-Friday 9am-6pm.
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/DUNG T ULSH/Examiner, Art Unit 3783
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