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 .
Status of Claims
Claims 31-45 are pending and examined on the merits.
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.
Claim(s) 31, 38-45 are rejected under 35 U.S.C. 103 as being unpatentable over Roura Fernandez et al. (US 2017/0330065) in view of Holbrook et al. (US 3,646,935).
Re Claim 31, Roura Fernandez discloses a plasma storage container (Fig. 1), comprising:
a bottle (bottle 1) including a neck (neck 12);
a connector (cylindrical cap 3) connected to the neck of the bottle (Fig. 3);
an inlet tube (second pipe 132, [0027] “a second pipe -132- which allows plasma to enter into the bottle -1-“) connected to the connector (Fig. 3); and
an outlet tube (first pipe 131, [0027] “first pipe -131- which allows extraction or ventilation and provides an outlet for the air inside the bottle-1-“) connected to the connector, wherein
the connector defines an inlet flow path extending from the inlet tube to an interior of the bottle (see Fig. 3), and
the connector defines an outlet flow path extending from the outlet tube to the interior of the bottle (also see Fig. 3).
Roura Fernandez does not disclose that a bottom end of the inlet flow path extends farther into the interior of the bottle than a bottom end of the outlet flow path. Holbrook discloses a body fluid bottle having an inlet for receiving bodily fluids from a patient, the inlet extends farther into the bottle interior than an outlet of the bottle (see Fig. 1 where inlet tube 36 extends near a bottom of the bottle). It would have been obvious to one skilled in the art at the time of filing to modify Roura Fernandez with the teaching of Holbrook such that body fluid would not splash and/or make loud noises as it enters the bottle.
Re Claim 38, Roura Fernandez and Holbrook combine to disclose claim 31, but neither expressly discloses wherein the connector is configured to be connected to the neck of the bottle via a snap-fit. Holbrook discloses that a cap/connector can be joined to a bottle by conventional means (col. 2 lines 40-43), thus suggesting to one skilled in the art that choosing one of the known means, such as a snap-fit, which is common for bottles with flip-caps, would be contemplated.
Re Claim 39, Roura Fernandez and Holbrook combine to disclose claim 31, and Roura Fernandez also discloses wherein the inlet tube is bonded to an inlet port of the connector, and the outlet tube is bonded to an outlet port of the connector ([0007]).
Re Claim 40, Roura Fernandez and Holbrook combine to disclose claim 39, but neither explicitly discloses wherein an outer surface of a proximal end of the inlet tube is bonded to an inner surface of the inlet port of the connector, and an outer surface of a proximal end of the outlet tube is bonded to an inner surface of the outlet port of the connector. However, a person of ordinary skill has good reason to pursue the known options (joining the tube to the port end-to-end, inserting tube into the port, or inserting the port into the tube) within his or her technical grasp. If this leads to the anticipated success (the tube and port are joined to allow fluid flow), it is likely that product was not of innovation but of ordinary skill and common sense. In that instant the fact that a combination was obvious to try might show that it was obvious under § 103. See MPEP 2143 (E).
Re Claim 41, Roura Fernandez and Holbrook combine to disclose claim 39, and Holbrook also discloses wherein an inner surface of a proximal end of the inlet tube is bonded to an outer surface of the inlet port of the connector, and an inner surface of a proximal end of the outlet tube is bonded to an outer surface of the outlet port of the connector (see Fig. 1). It would have been obvious to one skilled in the art at the time to further modify with the tube-port connection shown in Holbrook for easy attachment of the tube with the container.
Re Claim 42, Roura Fernandez and Holbrook combine to disclose claim 39, Roura Fernandez also discloses wherein the bottle includes a longitudinal central axis, and each of the inlet port and the outlet port extends in a substantially perpendicular direction with respect to the longitudinal central axis of the bottle (clearly shown in the figures).
Re Claim 43, Roura Fernandez and Holbrook combine to disclose claim 39, Roura Fernandez also discloses wherein the inlet port is oriented directly adjacent to the outlet port (see e.g., Fig. 1).
Re Claim 44, Roura Fernandez and Holbrook combine to disclose claim 39, Roura Fernandez also discloses wherein the inlet port is oriented substantially parallel to the outlet port (e.g., Fig. 2).
Re Claim 45, Roura Fernandez and Holbrook combine to disclose claim 31, but neither explicitly discloses that wherein the connector is unitarily formed. However, simply making a various structures of a connector integral/unitary without affecting the functions of the connector would amount to mere obvious engineering choice (MPEP 2144.04 (V)(B)).
Claim(s) 32 are rejected under 35 U.S.C. 103 as being unpatentable over Roura Fernandez and Holbrook as applied to claim 31 above, and further in view of Buttitta et al. (AU 2016101753).
Re Claim 32, Roura Fernandez and Holbrook combine to disclose claim 31, but they do not expressly disclose a substantially annular gasket positioned between the neck of the bottle and the connector to provide a seal along an interface therebetween. Buttitta discloses a medical storage bottle having a cap that fits over a top opening of the bottle (see Fig. 2), wherein a rim of the bottle top opening abuts against an annular gasket (gasket 166, see [0036]), which then abuts an interior surface of the cap. It would have been obvious to one skilled in the art at the time of filing to modify Roura Fernandez by adding a gasket between the cap and the bottle opening such that an improved liquid-tight seal can be achieved.
Claim(s) 36-37 are rejected under 35 U.S.C. 103 as being unpatentable over Roura Fernandez, Holbrook and Buttitta as applied to claim 32 above, and further in view of Hendricks (US 2008/0103475).
Re Claims 36-37, Roura Fernandez, Holbrook, and Buttitta combine to disclose claim 32, but they fail to disclose wherein the gasket is formed of an elastomeric material or a silicone elastomer material. Hendricks discloses a medical container formed as a bottle with a cap, wherein a gasket made of silicone elastomer is used to seal the cap to the container ([0028], [0054]). It would have been obvious to one skilled in the art at the time of filing to modify with the material taught by Hendricks since the selection of a material suitable for its intended use (i.e., a silicone elastomer used as a gasket) establishes a prima facie case of obviousness (MPEP 2144.07).
Allowable Subject Matter
Claims 33-35 are 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:
Re Claim 33, no prior art is found to disclose, inter alia, wherein the connector includes a downwardly extending stem at least partially received within the neck of the bottle. Bear et al. (US 2012/0248111) discloses a bottle with a cap having an inlet port and an outlet port, wherein the cap also has a stem surrounding the two ports, however, the stem is not received within the neck of the bottle (see Figs. 4 & 6).
Claim 34 is allowable at least for being dependent from claim 33.
Re Claim 35, no prior art is found to disclose, inter alia, wherein the neck of the bottle includes a substantially annular inner lip defining a seat for the gasket.
Conclusion
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/SUSAN S SU/ Primary Examiner, Art Unit 3781
29 May 2026