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. No claim amendments were submitted since the Non-Final Rejection mailed on . All claims are examined on the merits.
Response to Arguments
Applicant's arguments filed 9/2/2026 have been fully considered but they are not persuasive.
Applicant first argues that secondary reference Holbrook is not related to a plasma storage container and includes features that cannot be incorporated into the plasma storage container of primary reference Roura Fernandez. Examiner respectfully notes that Holbrook was merely cited to disclose that the inlet tube bottom end extends farther into the fluid receptacle/bottle than an outlet tube bottom end. Even though Roura Fernandez and Holbrook disclose fluid receptacles used under different medical procedures, Examiner notes that they may still be considered to be in the same field of endeavor because both are concerned with collecting bodily fluids from a patient through an inlet tube. Therefore one skilled in the art would find it within reason to look to Holbrook for the teaching of making an inlet tube that extends deeps into the fluid receptacle.
Applicant then argues that Holbrook’s relatively shorter outlet is used for applying suction into the container but a plasma storage container typically deform, therefore applying suction through the shorter outlet would not have been obvious. Examiner respectfully contends that Holbrook was cited for teaching an inlet tube that extends deep into the fluid receptacle and not for teaching using suction on the bottle, thus Applicant’s argument is not persuasive. Additionally, Roura Fernandez does not expressly disclose that the plasma storage container is deformable, and Applicant’s reasoning does not have any bearing on the presented prior art combination.
Applicant argues that Holbrook’s relatively long inlet tube will submerge in a container filled with plasma and this is different from what typically occurs in plasma storage containers such as one taught by Roura Fernandez. Examiner notes that Roura Fernandez does not criticize submerging the inlet tube in plasma and also does not explicitly require that the inlet tube must remain well above the bottom of the fluid receptacle. Since both Roura Fernandez and Holbrook disclose fluid receptacles for receiving and storing bodily fluids, and there is no apparent disadvantage to likely submerging the inlet tube in bodily fluid, the same bodily fluid that enters the fluid receptacle via the inlet tube, Examiner reasons that one skilled in the art is free to choose an inlet tube that extends any length within the fluid receptacle. A longer inlet tube, i.e., one that extends closer to the bottom of the fluid receptacle, would prevent bodily fluid from free-falling toward said bottom, thus reducing noise and splashing.
Applicant lastly argues that because the inlet and outlet of Roura Fernandez’s bottle are spaced apart, there’s no risk of plasma migrating directly from the inlet to the outlet and thus no need to change the length of the inlet to avoid this migration. Examiner notes that the examiner's reason or motivation to combine prior art references does not need to be the same as the Applicant's purpose or problem, and Examiner has already met her burden in presenting a rationale as to why one skilled in the art may want to make the inlet tube longer such that it would extend deeper into the fluid receptacle/bottle.
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.
Claims 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:
See reasons provided in Non-Final Rejection mailed on 6/3/2026.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/SUSAN S SU/ Primary Examiner, Art Unit 3781
14 October 2026
