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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 14 July 2025 has been entered.
Response to Amendment
This office action is responsive to the amendment filed on 14 July 2025. As directed by the amendment: claims 1 and 11 have been amended, claim 4 remains canceled. Thus claims 1-3 and 5-14 are presently pending in this application.
Response to Arguments
Applicant's arguments filed 14 July 2025 have been fully considered but they are not persuasive. Applicant argues that the art of record fails to teach the weakened portion configured to directly engage a distal end of a tip of a container. Applicant argues that the weakened portion of Okihara is not configured to directly engage with a distal end of a tip of a container because the lock adapter 6 sits between the weakened portion 91 and the tip of the syringe 2.
The position of the examiner is that the lock adapter 6 of Okihara is equivalent to the collar of the instant invention. The instant invention, as outlined in the 112(a) rejections below, also includes the weakened portion engaging the collar surrounding the tip of the container, it is not engaging the tip of the container with the fluid passageway as claimed. As such, there is not adequate written support for the claimed engagement. The claims are being interpreted consistent with the specification and drawings of the instant invention instead, and the prior art of record does teach the claims as interpreted.
Claim Objections
Claim 11 is objected to because of the following informalities:
Claim 11 recites “a projection extending outwardly formed on a collar of the container” in line 13. There is already antecedent basis for a collar provided in line 4 of claim 11, so this should instead recite “a projection extending outwardly formed on [[a]]the collar of the container”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-3 and 5-14 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1 and 11 both recite “the weakened portion configured to directly engage a distal end of the tip of the container”. In Applicant’s REMARKS, page 7, applicant indicates the limitations have support in Figure 3, saying “the weakened portion 49 engages with the distal end of the tip 23 of the container." However, as shown in annotated Fig 3, this is not accurate. The weakened portion 49 does not directly engage with the tip 23. Instead, the weakened portion 49 contacts and directly engages with the collar 25. The originally filed disclosure shows intervening structures, including the collar 25 and the inner skirt 44, between the weakened portion 49 and the tip of the container 23.
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Applicant also cites page 7 lines 23-30 as providing support for the amendment. However, this portion of the specification describes how the weakened portion 49 is attached to the proximal member 48 and the outer skirt 45 which are other parts of the cap. There is no mention of the weakened portion being in contact with the tip 23 of the container 20.
Claims 2-3 and 5-10, and 12-14 are rejected as being dependent on claims 1 and 11.
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 1-3 and 5-14 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.
Claims 1 and 11 both recite “the weakened portion configured to directly engage a distal end of the tip of the container”. It is unclear how the weakened portion can directly engage a distal end of the tip of the container with the intervening structures of the inner skirt and the collar, and of the elastomeric inner cap closing the fluid passageway.
For the purpose of examination, this limitation is being interpreted instead as “the weakened portion configured to directly engage a distal end of the [[tip ]]collar of the container” because this is what is depicted in Fig 3.
Claims 2-3 and 5-10, and 12-14 are rejected as being dependent on claims 1 and 11.
Claim Rejections - 35 USC § 103
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3, 5-10, and 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Imbert (US 6,190,364 B1) in view of Okihara et al. (US 2015/0011936 A1), Jansen (US 6,196,998 B1), and Carrel et al. (WO 2015/055608 A1).
Regarding claim 1, Imbert discloses a tip cap assembly (Fig 8) to close a fluid passageway (24 Fig 1) extending through a tip (tip 122 Fig 8) of a container (112 Fig 8) of a medical injection system (Fig 8), the tip cap assembly comprising: a rigid outer cap (58 Fig 8) comprising an inner skirt (the part of outer cap 58 with threads) extending proximally and having an outer threaded surface (82 Fig 6), and a body having a cavity formed therein (76 Fig 6), and an elastomeric inner cap (56 Fig 8) arranged within the cavity of the rigid outer cap, the elastomeric inner cap having a protrusion extending proximally and adapted to close the fluid passageway (See Fig 8, a piece of the elastomeric inner cap 56 protrudes into the fluid passageway), wherein: the rigid outer cap further comprises an outer skirt (86 Fig 8) extending proximally and around the inner skirt so as to define an annular groove between the inner skirt and the outer skirt (Fig 8), the outer skirt comprises a proximal member (See Fig 8, the part of 86 adhesively applied to the luer collar 144) a collar (144 Fig 8) of the container, in which the collar is formed integral with the container (Col 6 Lines 43-44), the inner skirt extends beyond the proximal member of the outer skirt in a proximal direction (Fig 8), the inner skirt is part of the rigid outer cap (See threaded section integral with cap 58 Fig 8, Col 4 lines 64-68), and an inner circumferential surface (76 Fig 6) of the rigid outer cap comprises a retaining clip (80 Fig 6), wherein the retaining clip is configured to maintain the elastomeric inner cap in place within the rigid outer cap (Col 5 lines 51-59, “substantially prevent further axial movement between inner and outer caps 56 and 58 respectively”).
However, Imbert fails to disclose the proximal member having a projection extending inwardly or a recess depressed outwardly, wherein the projection extending inwardly or the recess depressed outwardly is configured to lockingly engage with a corresponding recess depressed inwardly or a projection extending outwardly formed on the collar of the container, the outer skirt further comprising a weakened portion configured to act as a tamper evidence member, the weakened portion configured to directly engage a distal end of the collar (see the claim interpretation in the 112a rejections above) of the container, the inner skirt includes an inner circumferential surface that includes a proximal portion that extends substantially parallel to a longitudinal axis of the rigid outer cap and a distal portion that extends outwardly at an angle relative to the longitudinal axis of the rigid outer cap and wherein the outer skirt is part of the rigid outer cap, and wherein the retaining clip is a plurality of retaining clips that directly contact a distalmost surface of the elastomeric inner cap.
Okihara et al. teaches a proximal member (8 Figs 3 & 4) having a projection (81 Fig 4) extending inwardly, wherein the projection extending inwardly is configured to lockingly engage ([0041] “the projections 81 and the crest portions 630 constitute a distal end direction movement restricting section”) with a corresponding a projection extending outwardly (630 Fig 4) formed on a collar (6 Fig 4- the lock adapter 6 of Okihara is equivalent to the collar of the tip of the container of Imbert as it surrounds the elongated tip with the fluid passageway extending therethrough and it allows threaded engagement with a mating member, Okihara 6 Fig 4, Imbert 144 Fig 8), the outer skirt further comprising a weakened portion (91 Fig 5, [0066]) configured to act as a tamper evidence member ([0066], [0076]-[0077] the breaking of the thin portions 91 upon unsealing provides tamper evidence), the weakened portion configured to engage a distal end of the collar of the container (the weakened portion 91 Fig 5 is the interface between 7 and 8 [0031] “a breaking section 9 that has a function to link the cap main body 7 with the mounting section 8.” When the cap is pulled off, the weakened portion 9 engages the distal end of the adapter 6 through a force on projections 81 and the crest portions 630), and wherein the outer skirt (75 Fig 4) is part of the rigid outer cap (5 Fig 3, integrally formed [0069]). It would have been obvious to one of ordinary skill at the time of effective filing for the device of Imbert to have a proximal member having a projection as taught by Okihara et al. since such a modification is the result of a simple substitution of one known element (tamper evident tearable label adhesively applied) for another (tamper evident ring with projection extending from the rigid outer cap engaging with a corresponding projection extending from the collar of the tip) to achieve a predictable result (confirm that the device has been used/tampered with upon removal of the cap). Additionally, manufacturing the outer skirt as integral with the rigid outer cap as taught by Okihara et al. instead of as a separate component made of a different material can simplify the manufacturing process, reducing time and costs.
Jansen teaches the weakened portion (86 Fig 5) configured to directly engage a distal end of the collar (44 Fig 5) of the container. It would have been obvious to one of ordinary skill in the art at the time of effective filing for the weakened portion of modified Imbert to be configured to directly engage a distal end of the collar of the container as taught by Jansen since such a modification is an obvious matter of design choice. Shifting the particular placement of the weakened portion of modified Imbert from the unclear placement near the collar of Okihara to directly engage the distal end of the collar as taught by Jansen would not have modified the operation of the device.
Carrel et al. teaches a rigid outer cap (40 Fig 6B) comprises a plurality of retaining clips (42e Fig 6B) that directly contact a distalmost surface (53 Fig 6B) of the elastomeric inner cap (50 Fig 6B) (Page 14, lines 2-4 “The elastomeric inner cap 50 is distally blocked by the contact between its distal face 53 and the abutment surfaces 42e of the rigid cap 40”). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the retaining clips of modified Imbert to be structured as taught by Carrel et al. to provide stress-limiting means that allow the elastomeric cap to be substantially deformed when the tip cap assembly closes the passageway of the syringe, preventing unintended deformation of the rigid cap due to stress resulting of the compression of the elastomeric cap over time (Page 16 Lines 20-26). Additionally moving the plurality of retaining clips to contact the distalmost surface would facilitate correct placement of the retaining clips with respect to the inner cap during assembly by making the connection visible.
Carrel et al. further teaches an inner skirt (44 Fig 7) includes an inner circumferential surface (See the interior in Fig 3C) that includes a proximal portion (44a Fig 7) that extends substantially parallel to a longitudinal axis of the rigid outer cap (44a is defined as frustoconical which is not entirely parallel to a longitudinal axis of the rigid outer cap as it is designed to bias against the distal tip, but it can be described as “substantially parallel” as claimed, especially when it is biased outward from its inward angle upon rotating the cap onto the tip as shown in Fig 7) and a distal portion (the surfaces of 43a as shown in Fig 3C) that extends outwardly at an angle relative to the longitudinal axis of the rigid outer cap (the inner surfaces of 43a are angled relative to A’ as shown in Fig 3C). It would have been obvious to one of ordinary skill in the art at the time of effective filing to include the inner circumferential surface with the limitations as taught by Carrel et al. to provide sufficient structure to replace the proximal portion of the elastomeric inner cap of Imbert with a portion of the inner skirt so that, when said tip cap assembly is connected the elastomeric inner cap contacts the distally projecting tip only at the distal surface as this “reduces or cancels the sticking phenomenon that may happen after an extended period of storage and therefore allows a quick and easy removal of the tip cap assembly from the injection system”. (Page 3 lines 18-32) while allowing the rigid inner cap to “ensure a circumferential sealing of the distal projecting tip” (Page 9 lines 26-29).
Regarding claim 2, modified Imbert teaches the tip cap assembly of claim 1. Okihara et al. further teaches wherein the proximal member (8 Fig 4) is connected to the outer skirt (75 Fig 4) by the weakened portion (91 Fig 5).
Regarding claim 3, modified Imbert teaches the tip cap assembly of claim 2. Okihara et al. further teaches wherein the proximal member (8 Fig 3), the outer skirt (75 Fig 3) and the weakened portion (9 Fig 3) are integrally formed with each other [0069].
Regarding claim 12, modified Imbert teaches the tip cap assembly of claim 1. However, modified Imbert fails to teach wherein the rigid outer cap further comprises one or more openings extending through both an outer circumferential surface and the inner circumferential surface thereof to expose the cavity from outside the rigid outer cap.
Carrel et al. teaches wherein the rigid outer cap (40 Fig 3C) further comprises one or more openings (42b Fig 3C) extending through both an outer circumferential surface and the inner circumferential surface thereof (see extension of window 42b in Figs 3C and 3E) to expose the cavity (41a Fig 3C) from outside the rigid outer cap. It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention for the rigid outer cap of modified Imbert to include the openings with the limitations as taught by Carrel et al. to provide stress-limiting means that allow the elastomeric cap to be substantially deformed when the tip cap assembly closes the passageway of the syringe, preventing unintended deformation of the rigid cap due to stress resulting of the compression of the elastomeric cap over time (Page 16 Lines 20-26).
Regarding claim 5, Imbert discloses a medical injection system (Fig 8) comprising: a container including a longitudinal barrel (112 Fig 8), a tip (tip 122) projecting distally from the barrel and provided with a fluid passageway (24 Fig 1) extending through the tip, and a collar (144 Fig 8) extending around the tip (the collar 144 extends around 122 Fig 8), the collar having an internal threaded surface (See internal threaded surface of 144 Fig 8, Col 2 lines 48-49 “threads of a luer collar integral with or mounted to the syringe barrel”) facing an external surface of the tip. Modified Imbert teaches the tip cap assembly of claim 1 (See rejection of claim 1 above) which is screwed onto the collar in cooperation between the outer threaded surface of the outer cap and the internal threaded surface of the collar so as to close the fluid passageway (See cooperation in Fig 8, Col 6 lines 45-48 ”Cap assembly 54, as identified and described above is threadedly engaged with luer collar 144 such that elastomeric inner cap 56 sealingly engages tip 122 of syringe barrel 112.”). Modified Imbert further teaches wherein the proximal member of the outer skirt retains the outer cap onto the collar at a predetermined position relative to each other (See Fig 8, the modified proximal member would prevent longitudinal movement of the components relative to each other until enough force is provided to tear a frangible portion, Okihara- [0041] “the projections 81 and the crest portions 630 constitute a distal end direction movement restricting section”), and a longitudinal gap is provided between a distal end of the collar and a proximal end of the groove when the outer cap is retained onto the collar by the proximal member (See the gap in annotated Fig 8 below).
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Regarding claim 6, modified Imbert teaches the medical injection system of claim 5. Okihara et al. further teaches wherein the collar has a complementary shape (Fig 4, “Proximal end side of the grooves 63” [0039]) to the projection (81 Fig 4) formed on the proximal member of the outer skirt.
Regarding claim 7, modified Imbert teaches the medical injection system of claim 6. Okihara et al. further teaches wherein the collar has a recess or protrusion (Fig 4, “Proximal end side of the grooves 63” [0039]) engaged with the protrusion (81 Fig 4) of the proximal member.
Regarding claim 8, modified Imbert teaches the medical injection system of claim 5. Imbert further teaches wherein the collar and the container are integrally formed with each other (Col 6 Lines 43-44).
Regarding claim 9, modified Imbert teaches the medical injection system of claim 5. Modified Imbert further teaches wherein an inner surface (Carrel et al. 44a Fig 7) of the inner skirt of the outer cap is in contact with the external surface of the tip of the container (Page 17 Lines 18-34).
Regarding claim 10, modified Imbert teaches the medical injection system of claim 5. Imbert further teaches wherein the proximal member has an annular shape around the collar (Col 6 Lines 57-59).
Regarding claim 13, modified Imbert teaches the medical injection system of claim 5. However, modified Imbert fails to teach wherein the rigid outer cap further comprises one or more openings extending through both an outer circumferential surface and the inner circumferential surface thereof to expose the cavity from outside the rigid outer cap.
Carrel et al. teaches wherein the rigid outer cap (40 Fig 3C) further comprises one or more openings (42b Fig 3C) extending through both an outer circumferential surface and the inner circumferential surface thereof (see extension of window 42b in Figs 3C and 3E) to expose the cavity (41a Fig 3C) from outside the rigid outer cap. It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention for the rigid outer cap of modified Imbert to include the openings with the limitations as taught by Carrel et al. to provide stress-limiting means that allow the elastomeric cap to be substantially deformed when the tip cap assembly closes the passageway of the syringe, preventing unintended deformation of the rigid cap due to stress resulting of the compression of the elastomeric cap over time (Page 16 Lines 20-26).
Claims 11 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Imbert (US 6,190,364 B1) in view of Roedle et al. (US 2013/0338603 A1), Jansen (US 6,196,998 B1), and Carrel et al. (WO 2015/055608 A1).
Regarding claim 11, Imbert discloses a process for producing a medical injection system, the medical injection system comprising a container (112 Fig 8) formed with a fluid passageway (24 Fig 1) extending4TT8076.DOCxPage 3 of 9Application No. 16/317,065 Paper Dated: August 26, 2020through a distal tip (tip 122, collar 144 Fig 8) of the container and a tip cap assembly (Fig 8) adapted to close the fluid passageway, the container comprising a collar (144 Fig 8) extending around the tip (the collar 144 extends in a ring on the distal end 116 of the container 112 Fig 8), the tip cap assembly comprising: a rigid outer cap (58 Fig 8) comprising an inner skirt (the part of outer cap 58 with threads) extending proximally and having an outer threaded surface (82 Fig 6), and a body having a cavity formed therein (76 Fig 6), the rigid outer cap further including an outer skirt (86 Fig 8) comprising a proximal member (See Fig 8, the part of 86 adhesively applied to the luer collar 144), a collar (144 Fig 8) of the container, in which the collar is formed integral with the container (Col 6 Lines 43-44), an elastomeric inner cap (56 Fig 8) arranged within the cavity of the rigid outer cap, the elastomeric inner cap having a protrusion extending proximally and adapted to close the fluid passageway (See Fig 8, a piece of the elastomeric inner cap 56 protrudes into the fluid passageway), wherein the outer skirt (86 Fig 8) extends around the inner skirt so as to form an annular groove between the inner skirt and the outer skirt (See the groove in Fig 8), wherein the inner skirt extends beyond the outer skirt in a proximal direction (See the inner skirt extending beyond 86 Fig 8), and further wherein the inner skirt is part of the tip cap assembly (See threaded section integral with cap 58 Fig 8, Col 4 lines 64-68), and an inner circumferential surface (76 Fig 6) of the rigid outer cap comprises a retaining clip (80 Fig 6), wherein the retaining clip is configured to maintain the elastomeric inner cap in place within the rigid outer cap (Col 5 lines 51-59, “substantially prevent further axial movement between inner and outer caps 56 and 58 respectively”), the process comprising: screwing the tip cap assembly onto the collar such that the collar is introduced to the groove until the tip cap assembly reaches a predetermined position relative to the collar so as to form a longitudinal gap between a distal end of the collar and a proximal end of the groove (Col 6 Lines 44-47 “Cap assembly 54, as identified and described above is threadedly engaged with luer collar 144 such that elastomeric inner cap 56 sealingly engages tip 122 of syringe barrel 112.”, Fig 8 shows the inner cap sealingly engaging the syringe barrel while a longitudinal gap remains between a distal end of the collar and a proximal end of the groove).
However, Imbert fails to disclose the rigid outer cap further comprising a weakened portion configured to act as a tamper evidence member, the weakened portion configured to directly engage a distal end of the collar (see the claim interpretation in the 112a rejections above) of the container, the proximal member having a projection extending inwardly or a recess depressed outwardly, wherein the projection extending inwardly or the recess depressed outwardly is configured to lockingly engage with a corresponding recess depressed inwardly or a projection extending outwardly formed on a collar of the container, wherein the outer skirt is part of the tip cap assembly that is screwed onto the collar, wherein the retaining clip is a plurality of retaining clips that directly contact a distalmost surface of the elastomeric inner cap. the inner skirt includes an inner circumferential surface that includes a proximal portion that extends substantially parallel to a longitudinal axis of the rigid outer cap and a distal portion that extends outwardly at an angle relative to the longitudinal axis of the rigid outer cap.
Roedle et al. teaches the rigid outer cap (11, 15 Fig 1) further comprising a weakened portion ([0022] “at least one tear-off strip that connects the securing cap 11 and the securing ring 15 is provided, so that these elements are more or less connected with one another by way of a planned breaking point.”) configured to act as a tamper evidence member (when the tear off strips are broken, the use of the device would be clearly indicated, providing tamper evidence), the weakened portion configured to engage a distal end of the collar of the container (the weakened portion is the interface between 11 and 15, the ring 15 engages the distal end of the collar of the container 13, [0034] “The securing ring 15 then also lies against the holding ring 13, preferably under bias”, When the cap 11 is pulled off, the weakened portion engages the distal end of the collar of the container through the force connecting the securing ring 15 against the holding ring 13 and through the forces on the undercut 21 and the projection 19), a proximal member (15 Fig 1) having a projection extending inwardly (19 Fig 1), wherein the projection extending inwardly is configured to lockingly engage ([0025] ”The securing ring 15 has a preferably ring-shaped projection 19, which projects radially inward, with which it engages behind an undercut 21 on the holding ring 13”, “It is then preferably no longer possible to separate the securing ring 15 from the holding ring 13 in destruction-free manner.”) with a corresponding recess depressed inwardly (21 Fig 1) formed on a collar (13 Fig 1- the holding ring 13 of Roedle et al. is equivalent to the collar of the tip of the container of Imbert as it surrounds the elongated tip with the fluid passageway extending therethrough and it allows threaded engagement with a mating member, Roedle et al. 13 Fig 1, Imbert 144 Fig 8), wherein the outer skirt (11 & 15 Fig 1) is part of the tip cap assembly (3 Fig 1) that is placed onto the collar (13 Fig 1). It would have been obvious to one of ordinary skill at the time of effective filing for the outer skirt of Imbert to be part of the tip cap assembly as taught by Roedle et al. since such a modification is the result of a simple substitution of one known element (tamper evident tearable label adhesively applied) for another (tamper evident ring with projection extending from the rigid outer cap engaging with a corresponding recess in the collar of the tip) to achieve a predictable result (confirm that the device has been used/tampered with upon removal of the cap). Additionally, manufacturing the outer skirt as integral with the rigid outer cap as taught by Roedle et al. instead of as a separate component made of a different material can simplify the manufacturing process, reducing time and costs.
Jansen teaches the weakened portion (86 Fig 5) configured to directly engage a distal end of the collar (44 Fig 5) of the container. It would have been obvious to one of ordinary skill in the art at the time of effective filing for the weakened portion of modified Imbert to be configured to directly engage a distal end of the collar of the container as taught by Jansen since such a modification is an obvious matter of design choice. Shifting the particular placement of the weakened portion of modified Imbert from the unclear placement near the collar of Roedle et al. to directly engage the distal end of the collar as taught by Jansen would not have modified the operation of the device.
Carrel et al. teaches a plurality of retaining clips (42e Fig 3C) that directly contact a distalmost surface (53 Fig 6B) of the elastomeric inner cap (50 Fig 6B)(Page 14, lines 2-4 “The elastomeric inner cap 50 is distally blocked by the contact between its distal face 53 and the abutment surfaces 42e of the rigid cap 40”). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the retaining clips of modified Imbert to be structured as taught by Carrel et al. to provide stress-limiting means that allow the elastomeric cap to be substantially deformed when the tip cap assembly closes the passageway of the syringe, preventing unintended deformation of the rigid cap due to stress resulting of the compression of the elastomeric cap over time (Page 16 Lines 20-26). Additionally moving the plurality of retaining clips to contact the distalmost surface would facilitate correct placement of the retaining clips with respect to the inner cap during assembly by making the connection visible.
Carrel et al. further teaches an inner skirt (44 Fig 7) includes an inner circumferential surface (See the interior in Fig 3C) that includes a proximal portion (44a Fig 7) that extends substantially parallel to a longitudinal axis of the rigid outer cap (44a is defined as frustoconical which is not entirely parallel to a longitudinal axis of the rigid outer cap as it is designed to bias against the distal tip, but it can be described as “substantially parallel” as claimed, especially when it is biased outward from its inward angle upon rotating the cap onto the tip as shown in Fig 7) and a distal portion (the surfaces of 43a as shown in Fig 3C) that extends outwardly at an angle relative to the longitudinal axis of the rigid outer cap (the inner surfaces of 43a are angled relative to A’ as shown in Fig 3C). It would have been obvious to one of ordinary skill in the art at the time of effective filing to include the inner circumferential surface with the limitations as taught by Carrel et al. to provide sufficient structure to replace the proximal portion of the elastomeric inner cap of Imbert with a portion of the inner skirt so that, when said tip cap assembly is connected the elastomeric inner cap contacts the distally projecting tip only at the distal surface as this “reduces or cancels the sticking phenomenon that may happen after an extended period of storage and therefore allows a quick and easy removal of the tip cap assembly from the injection system”. (Page 3 lines 18-32) while allowing the rigid inner cap to “ensure a circumferential sealing of the distal projecting tip” (Page 9 lines 26-29).
Regarding claim 14, modified Imbert teaches the process of claim 11. However, modified Imbert fails to teach wherein the rigid outer cap further comprises one or more openings extending through both an outer circumferential surface and the inner circumferential surface thereof to expose the cavity from outside the rigid outer cap.
Carrel et al. teaches wherein the rigid outer cap (40 Fig 3C) further comprises one or more openings (42b Fig 3C) extending through both an outer circumferential surface and the inner circumferential surface thereof (see extension of window 42b in Figs 3C and 3E) to expose the cavity (41a Fig 3C) from outside the rigid outer cap. It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention for the rigid outer cap of modified Imbert to include the openings with the limitations as taught by Carrel et al. to provide stress-limiting means that allow the elastomeric cap to be substantially deformed when the tip cap assembly closes the passageway of the syringe, preventing unintended deformation of the rigid cap due to stress resulting of the compression of the elastomeric cap over time (Page 16 Lines 20-26).
Conclusion
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/A.E.V./Examiner, Art Unit 3783
/COURTNEY FREDRICKSON/Primary Examiner, Art Unit 3783
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