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 .
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.
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.
Claims 11, 12, 14 and 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Haefele et al. (PG PUB 2015/0165127) in view of Erhard (US Pat 2,029,020) and Imbert (US Pat 5,624,402).
Re claim 11, Haefele discloses a tip cap assembly 1 (Fig 6; it is noted that all reference characters cited below refer to Fig 6 unless otherwise noted; it is also noted that Para 106, 111, 112 and 123 discloses that tip cap assembly 1 includes safety cap 9, closure element 15, closure securing unit 17 and closing stopper 23) adapted to close a fluid passageway of a distally projecting tip of an injection system (it is noted that the italicized text constitutes functional language and, therefore, “an injection system” having “a distally projecting tip” with “a fluid passageway” is not a part of the claimed invention; this limitation is met in view of Fig 1a), said tip cap assembly comprising: an elastomeric inner cap 15 (Para 72) having protrusion 16 (Para 117, “protrusion”) extending proximally (as seen in Fig 6); and a rigid outer cap 17 which is securely disposed around said elastomeric inner cap (via form fit 31), the rigid outer cap comprising at least one window (through which protrusions 29 extend in Fig 6; Fig 3b shows two such windows separated by connecting means 20) defined in a circumferential side surface of the rigid outer cap (as seen in Fig 6) and that extends through an outer surface (the outer cylindrical surface, seen in Fig 3b,6) of said rigid outer cap (Para 145), wherein a portion 29 of the elastomeric inner cap rests in the at least one window (as seen in Fig 6; Para 145), wherein the rigid outer cap further comprises an opening (through which the cap 15 extends) at a distal end (directed upward in Fig 6) thereof, wherein the at least one window includes a first longitudinal rib 20 (towards the top in Fig 3b) on a first side of the at least one window and a second longitudinal rib 20 (towards the bottom in Fig 3b) on an opposing second side of the at least one window (as seen in Fig 3b). Haefele does not disclose that the protrusion of the inner cap is frustoconical with a proximal-most face or that the opening at the distal end of the outer cap is tapered.
Erhard, however, teaches providing an elastomeric cap 14 (Fig 1) with a protrusion 18 (Fig 1) extending proximally and having a proximal-most face (facing downward in Fig 1), wherein the protrusion is frustoconical (as seen in Fig 1 and described in Page 1, Col 2, Lines 49-50) for the purpose of adding to the effectiveness of the seal provided by the plate-like sealing member from which the protrusion projects and holding the cap against accidental removal (Page 1, Col 2, Line 51 – Page 2, Col 1, Line 14). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Haefele to include the protrusion of the inner cap with a frustoconical shape, as taught by Erhard, for the purpose of adding to the effectiveness of the seal provided by the plate-like sealing member from which the protrusion projects and holding the cap against accidental removal (Page 1, Col 2, Line 51 – Page 2, Col 1, Line 14).
Additionally, Imbert teaches a cap 54 (Fig 1) comprising a rigid outer cap 58 (Fig 1) and an elastomeric inner cap 56 (Fig 1), wherein the rigid outer cap comprises an opening (the portion of aperture 76 (labeled in Fig 6) residing to the left of the inner cap 56 in Fig 4) at a distal end 74 (Fig 1) thereof, wherein the opening is tapered (as seen in Fig 4; also, as seen in Fig 6, this portion tapers outward distally from the portion of aperture 76 having major inside diameter “d” – Col 4, Lines 56-60) for the purpose of providing an opening that allows the inner cap to be inserted into the outer cap upon assembly (Col 5, Lines 27-29). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Haefele to include the opening of the rigid outer cap with a taper, as taught by Imbert, for the purpose of providing an opening that allows the inner cap to be inserted into the outer cap upon assembly (Col 5, Lines 27-29).
Re claim 12, Haefele discloses that the at least one window comprises two windows defined in the outer surface of said rigid outer cap (as seen in Fig 3b).
Re claim 14, Haefele discloses that the at least one window extends circumferentially around the outer surface of said rigid outer cap (as seen in Fig 3a,3b).
Re claim 16, Haefele discloses a stress-limiting element 54+26 for allowing said elastomeric inner cap to be substantially deformed when the tip cap assembly closes said fluid passageway (Para 141).
Re claim 17, Haefele discloses that the elastomeric inner cap and the rigid outer cap comprises a holding element 26+54 to secure said elastomeric inner cap into said rigid outer cap (Para 141).
Re claim 18, Haefele discloses that said holding element comprises a shoulder (formed by inner thread 26) provided into the rigid outer cap (as seen in Fig 6), and a radial rim (formed by outer thread 54) provided onto the elastomeric inner cap (as seen in Fig 6), said elastomeric inner cap being proximally blocked by contact between said radial rim and said shoulder (Para 141).
Re claim 19, Haefele discloses that said holding element comprises at least one abutment surface (formed by inner thread 26) provided into the rigid outer cap (as seen in Fig 6), and a distal face (formed by outer thread 26) provided onto the elastomeric inner cap (as seen in Fig 6), said elastomeric inner cap being distally blocked by contact between said at least one abutment surface and said distal face (Para 141).
Re claim 20, Haefele discloses an injection system (Fig 1a with the closure system 1 of Fig 6) comprising a longitudinal barrel 4 (Fig 1a,6), a distally projecting tip 8 (seen in Fig 6 but not labeled; labeled in Fig 9a) provided with a fluid passageway 6 (seen in Fig 6 but not labeled; labeled in Fig 9a) extending therethrough (as seen in Fig 6; Para 110), a distal surface (the upward-facing surface of the portion of the barrel 4 that reference arrows 4 and 7 point to in Fig 6) and a lateral surface (the radially-outer surface of tip 8, seen in Fig 6), wherein said injection system further comprises a tip cap assembly according to claim 11 (see the rejection of claim 11 above).
Allowable Subject Matter
Claims 1, 2 and 4-10 are allowable. The following is a statement of reasons for the indication of allowable subject matter: Independent claim 1 (upon which claims 2 and 4-10 depend) has been amended to include the subject matter of now-cancelled claim 3 that was indicated as allowable in the 4/29/2026 Office Action. Please see the 4/29/2026 Office Action for a detailed statement of reasons for allowance.
Response to Arguments
Applicant’s arguments filed 7/17/2026 have been fully considered but are not persuasive. Applicant argues that Haefele does not disclose two longitudinal ribs on sides of the at least one window (as was previously recited in now-cancelled claim 15 and is currently recited in independent claim 11). Specifically, Applicant argues that “connecting means 20 are positioned in a circumferential slot 28 […] which could be interpreted as a ‘window’” and, therefore, “the connecting means 20 are not provided on opposing sides of the circumferential slot 28”. The Examiner respectfully disagrees. Firstly, it is noted that reference character 28 is not referred to as a “circumferential slot”, but rather is referred to as a “connection region”. Secondly, as set forth in the rejections and supported by Fig 3b, the connection region 28 comprises two open portions longitudinally located between a lower part 18 (“securing ring”) of the outer cap and an upper part 19 (“securing part”) of the outer cap that are separated by two connecting means 20. Therefore, each of the open portions that reside between the two connecting means 20 are considered a “window” and each of the connecting means 20 are a “longitudinal rib”. If further understanding is needed, please see the annotated version of Fig 3b below.
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Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 KAMI A BOSWORTH whose telephone number is (571)270-5414. The examiner can normally be reached Monday - Thursday 8 am - 4 pm.
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/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
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