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.
Response to Arguments
Applicant’s arguments filed 1/22/2026 have been fully considered. The amendment to claim 1 overcomes the rejection set forth in the last Office Action utilizing Ranalletta and Gardner; accordingly, the arguments directed to these references are moot in view of the present rejections which no longer use these references. The argument directed to the previous rejection of claim 11 (the argument being that the opening indicated in the last Office Action belongs to connection element 57, not a distal end of the rigid outer cap) is persuasive; accordingly, the rejections of claims 11, 12 and 14-20 in the last Office Action are withdrawn and new rejections of these claims are set forth below using Imbert to teach the claims “tapered opening”.
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 1-2 and 5-10 are rejected under 35 U.S.C. 103 as being unpatentable over Okihara et al. (PG PUB 2015/0011936) in view of Erhard (US Pat 2,029,020).
Re claim 1, Okihara discloses a tip cap assembly 5 (Fig 2; it is noted that all reference characters cited below refer to Fig 2 and/or Fig 3 unless otherwise noted) 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, a fluid passageway, a tip and an injection system are not a part of the claimed invention; this limitation in view of Fig 3 that shows the cap closing a fluid passageway of tip 2 of syringe 2), said tip cap assembly comprising: an elastomeric inner cap 72 (Para 52, “elastic body”) having a protrusion extending proximally, said frustoconical protrusion having a proximal-most face (Para 62, “on the proximal end surface of the plate-like sealing member 72, a projected portion to be inserted into the distal end opening 221 of the reduced diameter section […] may be formed”); and a rigid outer cap 7+9+8 which is securely disposed around said elastomeric inner cap (Para 52, “press (fitted)”), the rigid outer cap comprising an outer ring 7 and a frustoconical extension 74 (Para 59, “outside diameter which are gradually increased in the proximal end direction corresponding to the shape of the reduced diameter section 22”) that extends from a proximal portion 71 of the rigid outer cap to come in direct contact with a lateral surface of the distally projecting tip (Para 57, “the inner ring 74 contacts the outer circumferential portion of the reduced diameter section 22), wherein the outer ring and the frustoconical extension of the rigid outer cap are formed integral with one another to form a monolithic structure (as seen in Fig 3), wherein the rigid outer cap defines a cavity 711 at a distal end thereof (at the distal end of the proximal portion 71, as seen in Fig 3) to receive the elastomeric inner cap (as seen in Fig 3; Para 52), in which the cavity is positioned distal from the outer ring and the frustoconical extension of the rigid outer cap (as seen in Fig 3), wherein a radial recess (seen between outer ring 75 and frustoconical extension 74, where lock adapter 6 resides in Fig 3) defined by the outer ring extends around at least a portion of the frustoconical extension of the rigid outer cap (as seen in Fig 3) for allowing a limited deformation of the frustoconical extension due to the contact with the lateral surface of the distally projecting tip (it is noted that the claim does not require the frustoconical extension to deform, it just requires the radial recess to allow for deformation; since the radial recess is wide enough to allow for deformation, this limitation is met). Okihara is silent as to the shape of that “projected portion” and, therefore, does not explicitly disclose that the protrusion is frustoconical.
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 Okihara 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).
Re claim 2, Okihara discloses that the radial recess extends around an entire circumference of the frustoconical extension of the rigid outer cap (as seen in Fig 2).
Re claim 5, Okihara discloses that the radial recess is configured to permit radial deformation of the frustoconical extension of the rigid outer cap (this claim, like claim 1, does not require the frustoconical extension to actually deform; since the radial recess would allow for such action, this limitation is met).
Re claim 6, Okihara discloses a stress-limiting element 712 for allowing said elastomeric inner cap to be substantially deformed when the tip cap assembly closes said fluid passageway (Para 53).
Re claim 7, Okihara discloses that the elastomeric inner cap and the rigid outer cap comprises a holding element (the inner lateral surface of recessed portion 711 of the outer cap and the lateral surface of the sealing member 72) to secure said elastomeric inner cap into said rigid outer cap (Para 52, due to the sealing member 72 being “pressed (fitted)” into the recessed portion 711).
Re claim 8, Okihara discloses that said holding element comprises a shoulder (shown in Fig 3 but not labeled; labeled in annotated Fig A below) provided into the rigid outer cap (as seen in Fig A and Fig 6), and a radial rim (the disc 72 itself) provided onto the elastomeric inner cap (as seen in Fig 3), said elastomeric inner cap being proximally blocked by contact between said radial rim and said shoulder (Para 52, due to the sealing member 72 being “pressed (fitted)” into the recessed portion 711).
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Re claim 9, Okihara discloses that said holding element comprises at least one abutment surface 712 provided into the rigid outer cap, and a distal face (facing to the left in Fig 3) provided onto the elastomeric inner cap, said elastomeric inner cap being distally blocked by contact between said at least one abutment surface and said distal face (as seen in Fig 3, Para 53).
Re claim 10, Okihara discloses an injection system 1 (Fig 1) comprising a longitudinal barrel 21 (Fig 1), a distally projecting tip 22 (Fig 2) provided with a fluid passageway (which ends in opening 221) extending therethrough, a distal surface (labeled in Fig A above) and a lateral surface (the radially-outward surface of tip 22), wherein said injection system further comprises a tip cap assembly according to claim 1 (as set forth in the rejection of claim 1 above).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Okihara et al. (PG PUB 2015/0011936)/Erhard (US Pat 2,029,020) in view of Hackmann et al. (PG PUB 2005/0051508).
Re claim 4, Okihara/Erhard disclose all the claimed features except that an inner surface of the frustoconical extension of the rigid outer cap comprises at least one ridge. Hackmann, however, teaches a tip cap assembly 1 (Fig 5) comprising a cap 1 (Fig 5) comprising a ring 70 (Fig 5) with an inner surface configured to come in direct contact with a lateral surface of a tip 56 (Fig 5) of a fluid system 50 (as seen in Fig 5; like how the frustoconical extension 74 comes into contact with the lateral surface of the tip 22 in Okihara) – which possesses the frustoconical extension – is configured to come in direct contact with the lateral surface of inner tip portion 54a), wherein an inner surface of the ring comprises at least one ridge 30,32 (Fig 5) for the purpose of increasing the retaining effect of the cap on the tip (Para 11). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Okihara/Erhard to include the inner surface of the frustoconical extension to comprise at least one ridge, as taught by Hackmann, for the purpose of increasing the retaining effect of the cap on the tip (Para 11).
Claims 11, 12 and 14-20 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 2,029020) 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. 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 15, Haefele discloses that 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).
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
Claim 3 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. The following is a statement of reasons for the indication of allowable subject matter: Dependent claim 3 requires the outer ring (of the rigid outer cap) to comprise a thread provided on its outer surface. Okinara (utilized in the rejection of claim 1 above) does not disclose that outer ring 75 has a thread provided on its outer surface, nor would it have been obvious to one of ordinary skill in the art at the time the invention was made to modify Okinara to include a thread on the outer surface of the outer ring since Okinara does not disclose that any exterior structure is intended to engage with the rigid outer cap. Absent a teaching of and benefit of providing a thread on an outer surface of the outer ring 75 of the rigid cap, it would not have been obvious to modify Okinara to include one.
Conclusion
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/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
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