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 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 1-9 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 1, it is unclear to the Examiner which element is referred to by 'a sliding component stop.' It appears to the Examiner that 'a sliding component stop' in claim 1 is equivalent to 'the slider stop' in claim 7. Therefore, are the limitations 'sliding component stop' and 'slider stop' the same component or different components?
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-9 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims1-7 of U.S. Patent No. 11,986,626. Although the conflicting claims are not identical, they are not patentably distinct from each other because they are not structurally distinguishable from the claims in the patents.
Regarding claim 1, US’626 discloses a two-stage infusion set inserter system comprising:
an inserter assembly comprising: a housing comprising: a rotatable button assembly comprising ramps and tab indents, see col. 20, lines 17-21; and
a non-rotatable portion of housing, see col. 20, line 22;
a sliding component comprising sliding component tabs, see col. 20, lines 23-24;
a needle carrier comprising spring fingers connected to an introduction needle, the needle carrier slidably movable from a starting position to an injection position and then to a second ending position, see col. 20, lines 25-28;
a sliding component spring, see col. 20, line 29;
a sliding component stop (e.g., equivalent to a slider stop in claim 6, col. 20, line 59); and
a needle spring, see col. 20, line 30;
wherein the rotatable button assembly rotates from a locked to an unlocked position, see col. 20, lines 33-34
wherein when force is applied onto the rotatable button assembly, the sliding component and needle carrier are forced downward by the sliding component spring, wherein when the needle carrier reaches the injection position, the needle spring forces the needle carrier upward towards the second ending position, see col. 20, lines 35-40, and
wherein when the needle carrier interacts with the slide stop, the slide stop forces the spring fingers inward and the needle carrier moves from the injection position to the ending position, see col. 20, lines 41-45.
Regarding claim 2, wherein when the rotatable button assembly is in the locked position, the sliding component tabs are in the tab indents, see claim 2 in US’626.
Regarding claim 3, wherein when the rotatable button assembly is in unlocked position, the ramps are in contact with the sliding component tabs, see claim 3 in US’626.
Regarding claim 4, further comprising an infusion set attached to the housing (Note: the housing is a part of the infusion set, see claim 1 above. Therefore, the infusion set attached to the housing).
Regarding claim 5, wherein the infusion set comprising a base and wherein the base comprising an adhesive layer, see col. 20, lines 31-32.
Regarding claim 6, wherein the adhesive layer comprising an adhesive liner, see claim 4 in US’626.
Regarding claim 7, further comprising a slider stop, wherein when the sliding component reaches the slider stop, the slider stop forces the sliding component to stop downward movement, see claim 6 in US’626.
Regarding claim 8, further comprising an introduction needle connected to the needle carrier, wherein when the needle carrier moves to the ending position, the introduction needle moves to the ending position and wherein the introduction needle is inside the housing portion, see claim 5 in US’626.
Regarding claim 9, wherein the rotatable button assembly comprising a first alignment indicia and the non-rotatable portion of housing comprising a second alignment indicia, wherein when the rotatable button assembly rotates from a locked position to an unlocked position, the first alignment indicia and the second alignment indicia line up to indicate the system is in the unlocked position, see claim 7 in US’626.
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.
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/Quynh-Nhu H. Vu/
Quynh-Nhu H Vu
Primary Examiner, Art Unit 3783
