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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 5/11/2026 has been entered.
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 14-16 and 21-27 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. The specification nor the figures adequately describe what the directionality of the one-way valve is and where the valve is located. The language “one-way” insinuates flow can only go from point A to point B, but those points are not specified. With this interpretation, a one-way valve like a flap valve would be oriented in a manner that prevents upward flow in the IV line when a drug is being added via the port, but would need to be moved entirely out of the way to then allow flow between the vial and the IV line. However, based on the discussion of said valve in the current Specification, it appears that “one-way” was meant to mean a binary on/off or open/closed type of flow wherein one position simply allows flow in a direction and another position does not allow that same flow in that direction—this is the interpretation used below.
Response to Arguments
Applicant's arguments filed 4/24/2026 have been fully considered but they are not persuasive. In view of the 35 U.S.C. 112(a) rejection above, Haber et al. (US 5647845 A) discloses a one-way valve. In the binary open/closed interpretation of the valve, Haber operates in the same manner. The first position of the claimed valve prevents fluid communication with the IV line, and Haber also has a first position with the same function. Similar with a second position, the claimed invention and Haber disclose a second position wherein fluid communication is allowed with the IV line. With the binary interpretation of “one-way”, either a fluid pathway is clear and allowing flow or it is not; Haber discloses such an interpretation.
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.
Claim(s) 14-15, 21-22, 25-27 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Haber et al. (US 5647845 A).
Regarding claim 14, Haber discloses a device (1) for use with a drug vial (100) having a cap (fig. 1), comprising:
a cap clasp (20) having at least two arms (28) adapted to selectively couple with the cap of the vial (column 5 lines 46-52);
a vial spike (16) generally centrally located between the at least two arms (28) and configured to pierce a seal of the vial (column 8 line 67 – column 9 line 2);
an intravenous (IV) line (82, fig. 12, column 8 lines 17-20) coupled with the vial spike (16, although fig. 8 shows the closed valve position not permitting flow, the spike 16 can connect to the pathway of the IV drip chamber);
a one-way valve (8) having a first position wherein the one-way valve is configured to prevent fluid communication with the IV line (column 9 lines 14-19, no communication with the IV line) and a second position wherein the one-way valve (8) is configured to allow fluid communication with the IV line (column 9 lines 32-47); and
a port (14) configured to allow fluid to be added to the device via a pathway separate from the vial spike (16) when the one-way valve is in the first position (column 8 lines 8-18).
Regarding claim 15, Haber discloses the device of claim 14 and further discloses wherein the at least two arms (28) are flexibly positionable around the cap of the vial (figs. 2A and 2B, column 5 lines 53-67).
Regarding claim 21, Haber discloses the device of claim 14 and further discloses wherein the port (14) is configured to allow the fluid to be added to the device for mixing with drug from the drug vial when the one-way valve is in the first position (column 9 lines 14-19).
Regarding claim 22, Haber discloses the device of claim 14 and further discloses a hub (2), wherein the hub is directly coupled with the IV line (82), the vial spike (16), and the port (14, fig. 12).
Regarding claim 25, Haber discloses the device of claim 14 and further discloses wherein the cap clasp comprises a third arm (28) adapted to selectively couple with the cap of the vial (figs. 2A and 2B).
Regarding claim 26, Haber discloses the device of claim 25 and further discloses wherein the cap clasp comprises a fourth arm (28) adapted to selectively couple with the cap of the vial (figs. 2A and 2B).
Regarding claim 27, Haber discloses the device of claim 26 and further discloses wherein the at least two arms, the third arm, and the fourth arm are circumferentially spaced around an outer periphery of the cap clasp (figs. 2A and 2B).
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.
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.
Claim(s) 23 and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Haber (US 5647845 A).
Regarding claim 23, Haber discloses the device of claim 14 and an IV line (82, fig. 12). However, Haber fails to expressly disclose wherein at least a portion of the IV line comprises at least one bend and/or is configured to bend during removal of the device from the vial.
While features of an apparatus may be recited either structurally or functionally, claims directed to a device must be distinguished from the prior art in terms of structure rather than function, because device claims cover what a device is, not what a device does (MPEP 2114). Thus, if a prior art structure is capable of performing the intended use as recited in the preamble, or elsewhere in a claim, then it meets the claim. In this case, the IV line of Haber is capable of performing the claimed function bending while the device is moved around when the vial is removed because the claim nor the specification discloses a non-traditional type of IV line that is well known to be flexible tubing that can be bent or twisted due to its flexible, often plastic, material.
Regarding claim 24, Haber discloses the device of claim 14 and the vial spike (16) and IV line (82). However, Haber fails to disclose wherein the vial spike and IV line are provided as a single, pre-assembled unit; rather, the IV line is a separate tube that is fitted into the port of the drip chamber of the device to establish a fluid connection.
Haber discloses the claimed invention except for that single, pre-assembled unit of the vial spike and the IV line. It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to have the IV line integrally formed with the device to create one single unit, since it has been held that forming a single assembly which has formerly been formed in two pieces and put together involves only routine skill in the art. MPEP 2144.04 V.B.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Haber (US 5647845 A) in view of Bloom et al. (US 4128098 A).
Haber discloses the device of claim 14 but fails to disclose wherein the vial spike includes at least one slot formed thereon.
Bloom teaches a similar device in the same field of endeavor wherein the vial spike includes at least one slot formed thereon (fig. 5, column 2 lines 36-41).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the spike of Haber and incorporate the slotted spike of Bloom to allow air to enter the passage to avoid a vacuum in the vial (column 2 lines 36-41).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIN A KIM whose telephone number is (703)756-4738. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm (EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached at (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERIN A KIM/Examiner, Art Unit 3781
/SUSAN S SU/Primary Examiner, Art Unit 3781 15 July 2026
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