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 .
Election/Restrictions
Applicant’s election without traverse of species a) figs 1-5b, claims 1-4, 15-22, and 24 in the reply filed on 05/02/2026 is acknowledged.
Claims 5-14, 23, 25-33 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/02/2026.
Please note that claims 5-11 have been withdrawn as to the non-elected species figures 7a-9. With respect to claim 12, content seems cited in [0013] but it is not shown in the drawings. The corresponding structure does not seem to read on elected figures 1-5b.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: reference numeral 228 not shown as set forth in [0081].
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 3, and 16-17 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.
Claim 3 is indefinite because there is a positive recitation of the delivery conduit with the phrase “is coupled”. Both the delivery conduit via a delivery conduit hub are part of the assembly not the valve structure as per disclosure.
Claim 17 recites the limitation "the second central longitudinal axis of the seal". There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2, 4, 15, 18-22, and 23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Weibel et al (US 10413672 B2).
Regarding claim 1, Weibel discloses a valve structure (fig 15) for selectively connecting a medicament container 1 to a delivery conduit 12, the valve structure comprising:
a valve housing 6 comprising a first portion (top portion at 24,26 in fig 15) that is configured to couple to a medicament container (fig 1), a second portion (bottom at 6 in fig 15) that is configured to couple to a delivery conduit 12 (fig 3), and a first opening (at top portion in fig 15) providing a fluid pathway from the first portion to the second portion; and
a seal 10 extending across the first opening for selectively sealing the first opening in the valve housing (see fig 3 and throughout its disclosure), the seal comprising a second opening 7,7”,11 (figs 2-15) extending therethrough,
wherein the seal 10 is rotatable relative to at least one of the first portion and the second portion of the valve housing between a first position in which the second opening is not in fluid communication with the first opening and a second position in which the seal is rotated such that the second opening is in fluid communication with the first opening (col. 7 line 55- col. 43; col. 9 lines 22-31).
Regarding claim 2, Weibel discloses wherein the at least one of the first portion and the second portion of the valve housing further comprises a sealing seat 5,8 (fig 3) surrounding the first opening in the valve housing, against which the seal is seated.
Regarding claim 4, Weibel discloses wherein: the first opening (at top portion in fig 15) has a first central longitudinal axis, the seal 10 has a second central longitudinal axis, the second opening 7,7”,11 (figs 2-15) has a third central longitudinal axis, and wherein the second central longitudinal axis is offset from the first and third central longitudinal axes in a transverse direction, or non-coaxial with the first and third central longitudinal axes (figs 2-15).
Regarding claim 15, Weibel discloses wherein the first central longitudinal axis, the second central longitudinal axis and the third central longitudinal axis are parallel to each other (first position).
Regarding claim 18, Weibel discloses wherein the seal is a circular disc (col. 3, lines 21-28).
Regarding claim 19, Weibel discloses wherein the first portion comprises a first generally cylindrical body and/or wherein the second portion comprises a second generally cylindrical body (fig 15).
Regarding claim 20, Weibel discloses wherein the first generally cylindrical body comprises a fourth central longitudinal axis and is substantially co-axial with the first central longitudinal axis (figs 2-15, second position).
Regarding claim 21, Weibel discloses wherein the sealing seat 5,8 provides a sealing surface disposed in the second portion of the valve housing.
Regarding claim 22, Weibel discloses wherein the second opening 7,7”,11 is in registry with the sealing surface when the seal is in the first position (fig 1).
Regarding claim 24, Weibel discloses wherein the seal comprises an elastomeric material (col 3 lines 37- 42).
Allowable Subject Matter
Claims 3, and 16-17 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892 form.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Cris L Rodriguez whose telephone number is (571)272-4964. The examiner can normally be reached Monday-Thursday 8am- 2pm..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at 571-270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Cris L. Rodriguez/
Primary Patent Examiner
Art Unit 3783
Prosecution Insights