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 .
Response to Arguments
Applicant's arguments filed 6/26/2026 have been fully considered.
Regarding the claim to priority, Applicant’s arguments have been considered and are not persuasive. Regarding the claim limitation “the volume displacing protrusion is configured to contact a distal end of the syringe before the distal end of the syringe forms an air-tight seal with the female luer taper of the hub”, Applicant points to portions of the ‘309 application that disclose that the sequence of steps are such that the syringe luer is locked with the injection device hub followed by creation of the internal luer seal. This argument is not convincing. The protrusion contacting the distal end of the syringe is not addressed in the portion cited by Applicant. The portion cited discusses the syringe luer locking with the injection device hub which is not analogous to the protrusion contacting a distal end of the syringe, and has nothing to do with the protrusion. There is no reason to assume that the protrusion performs any type of locking function between the syringe luer and the injection device hub. And further, the claim is drawn to a cap, and the portion cited by Applicant discusses an injection device hub, not a cap. Therefore, Applicant has not provided evidence that the claimed subject matter is supported in the prior disclosure.
Regarding the rejections under 112(b), the amendments to the claims overcome the rejection and the rejection is therefore withdrawn.
Regarding the rejection under 102 over Grabenkort, Applicant’s arguments have been considered and are not convincing. Applicant argues that Grabenkort does not disclose a volume displacing protrusion 72 that is monolithic with the hub and extends in a direction away from the end wall. Applicant points to Fig. 2 and cites a passage that describes the protrusion 72 slip fit into the fluid passageway 24. Applicant appears to be conflating the female luer hub of the cap 60 with the male luer of the syringe barrel. The protrusion 72 is monolithically formed with the entirety of the cap 60, including the hub formed on the first end of the cap and including the luer taper as shown in the annotated fig. 2 provided in the prior office action, as indicated by the cross-hatching.
Applicant provides similar arguments with regard to Shimazaki. Applicant appears to argue that the cap of Shimazaki is not monolithic with the hub of the syringe barrel. This is not what claim 1 requires. The claim calls for the cap having a hub that is configured to attach to a hub of the syringe barrel. This is what Shimazaki teaches. Regarding claim 10, the claims have been amended such that the flexible element is formed separate from the body and also monolithic with the hub which is part of the body. It does not appear as though these two things are both included in the disclosed invention.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 17/993,309, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The prior-filed applications fail to provide support for at least the volume displacing protrusion to be configured to contact a distal end of the syringe before the distal end of the syringe forms an air-tight seal with the female luer taper of the hub.
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 10-15 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. Claim 10 calls for a hub at the first end of a body portion, a flexible element formed separately from the body portion and coupled to the body portion, the flexible element having a volume displacing protrusion, and further that the volume displacing protrusion is monolithic with the hub. The disclosure does not provide support for the flexible element simultaneously being formed separately from the body portion and being monolithic with the hub which is part of the body portion.
Claims 11-15 inherit the deficiencies of claim 10.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-4, 7-9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Grabenkort (US 5,807,345).
Regarding claim 1, Grabenkort discloses a cap 60 for a syringe 10 (fig. 2), comprising: a body portion 62 having a first end and a second end (fig. 2 annotated below); an end wall (fig. 2 annotated below); a hub at the first end of the body portion (fig. 2 annotated below; col. 4, lines 21), the hub extending axially away from the end wall and having a first interior surface having a female luer taper configured to sealingly mate with a male luer taper of the syringe (col. 4, line 21; fig. 2); and a volume displacing protrusion 72 monolithic with the hub (fig. 2) and extending in a longitudinal axial direction away from the end wall (fig. 2); wherein: the volume displacing protrusion is configured to contact a distal end of the syringe before the distal end of the syringe forms an air-tight seal with the female luer taper of the hub (fig. 2: the length of the protrusion is such that the tip of the protrusion contacts the distal end of the syringe prior to the tip of the syringe contacting the female luer of the hub).
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Claim 2 calls for the volume displacing protrusion to have a spherical surface. The examiner notes that while the term “spherical” is used, it appears as through the surface is actually semi-spherical, not fully spherical, as can be seen in fig. 68E. The examiner is therefore adopting an interpretation of “spherical surface” consistent with Applicant’s disclosure. Grabenkort shows that the distal end of the volume displacing protrusion forms a spherical surface (fig. 2).
Regarding claim 3, Grabenkort discloses that the volume displacing protrusion 72 forms an air-tight seal against the distal end of the syringe (col. 4, lines 36-39) and due to the length of the protrusion, the volume displacing protrusion is configured to form an air-tight seal against the distal end of the syringe before the distal end of the syringe forms an air-tight seal with female luer taper of the hub (fig. 2).
Regarding claim 4, Grabenkort discloses that the volume displacing protrusion is configured to form an air-tight seal against the distal end of the syringe (col. 4, lines 36-39) and that it does so without inhibiting or preventing a plunger of the syringe from advancing to the distal end of the syringe (fig. 3: the protrusion does not extend fully into the syringe barrel).
Regarding claim 7, Grabenkort discloses a recess formed in the second end of the body portion of the cap (fig. 2: recess near number 80).
Regarding claim 8, Grabenkort discloses a depression formed in the end wall of the cap (fig. 2: depression near number 80), wherein the volume displacing protrusion 72 is formed in a first side of the end wall and the depression is formed in a second side of the end wall that is opposite to first side of the end wall (fig. 2), the depression removes material from the cap and therefore renders the end wall more flexible than if the depression was filled with material.
Regarding claim 9, Grabenkort discloses a kit, comprising the cap of Claim 1 as described above with regard to claim 1, and a syringe 10 (col. 3, line 6; fig. 2).
Claim(s) 1, 5, 6 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shimazaki et al (US 2011/0174647).
Regarding claim 1, Shimazaki discloses a cap 8 for a syringe 2 (fig. 2), comprising: a body portion 62 having a first end and a second end (fig. 2 annotated below); an end wall (fig. 2 annotated below); a hub at the first end of the body portion (fig. 2 annotated below), the hub extending axially away from the end wall and having a first interior surface having a female luer taper configured to sealingly mate with a male luer taper 3a of the syringe (page 3, para. 0061; fig. 2); and a volume displacing protrusion 8b monolithic with the hub (fig. 2) and extending in a longitudinal axial direction away from the end wall (fig. 2); wherein: the volume displacing protrusion is configured to contact a distal end 7b of the syringe before the distal end of the syringe forms an air-tight seal with the female luer taper of the hub (fig. 2).
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Regarding claim 5, Shimazaki discloses that wherein the end wall is flexible (page 4, para. 0065: rubber is flexible).
Regarding claim 6, Shimazaki discloses that the volume displacing protrusion is flexible (page 4, para. 0065: rubber is flexible).
Allowable Subject Matter
Claims 16, 18-20 are allowed.
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 LAURA A BOUCHELLE whose telephone number is (571)272-2125. The examiner can normally be reached Mon-Fri 8:00-5:00 CST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at 571-272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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LAURA A. BOUCHELLE
Primary Examiner
Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783
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