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 .
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.
Election/Restrictions
Claims 12-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the replies filed on 8/5/2025 and 11/25/2025.
It is noted that Applicants are still of the position (pages 6-7 of the response dated 11/25/2025) that a search of the different groups of claims is not a serious burden to the Examiner. In response, the Examiner has shown that the different groups of inventions are distinct and the prior art applicable to the device of claim 1 would not necessarily be applicable to the method claim 12. It is also noted that the sample can be drained from the vial by merely removing the inlet/outlet tube and removing the sample from the opening in the vial.
Claim Rejections - 35 USC § 102
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 1-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Woods (US 2014/0170634).
With respect to claim 1, the reference of Woods discloses:
A cryovial device (100)(Figs. 7-14) comprising:
a vial (102, 201) configured to hold a liquid sample;
an inlet/outlet tube (112, 223) coupled to the vial and constructed of a weldable polymer (heat sealable)(¶[0075]), the inlet/outlet tube having:
a filled configuration in which the inlet/outlet tube is coupled to a source of the liquid sample (Note: This claim limitation is considered a statement of intended use. The inlet/outlet tube (112, 223) is structurally capable of being coupled to a source of liquid sample and therefore meets the limitations of the claim); and
a drained configuration in which the inlet/outlet tube is coupled to a receiving tube (Note: This claim limitation is considered a statement of intended use. The inlet/outlet tube (112, 223) is structurally capable of being coupled to a receiving tube and therefore meets the limitations of the claim); and
a vent tube (114, 221) coupled to the vial (102, 201).
With respect to claim 2, the inlet/outlet tube (112, 223) is coupled to the vial (102, 201) at a first fitting (118, 208) and the vent tube (114, 221) is coupled to the vial (102, 201) at a second fitting (120, 207).
With respect to claim 3, the device of Woods discloses a sealing element (240) (Figs. 12), the sealing element including a first hole, the first hole receiving the inlet/outlet tube and compressing the inlet/outlet tube around the first fitting, the sealing element including a second hole, the second hole receiving the vent tube and compressing the vent tube around the second fitting (¶[0080]-[0081]).
With respect to claim 4, the inlet/outlet tube (112, 223) can be constructed of a thermoplastic elastomer (TYGON) (¶[0089]).
With respect to claim 5, the inlet/outlet tube (112, 223) is structurally capable of being welded to a receiving tube (¶[0075]).
With respect to claim 6, the inlet/outlet tube (112, 223) is structurally capable of being closed between a filled configuration and a drained configuration (¶[0075]).
With respect to claim 7, the inlet/outlet tube (112, 223) is structurally capable of being heat-sealed the closed configuration (¶[0075]).
With respect to claim 8, the inlet/outlet tube (112, 223) is structurally capable of being heat-sealed beyond an extension of the vent tube (114, 221) from the vial (¶[0075]).
With respect to claim 9, the vent tube (114, 221) is structurally capable of being heat-sealed in the closed configuration (¶[0075]).
With respect to claim 10, the inlet/outlet tube (112, 223) is structurally capable of being shorted between the filled configuration and the drained configuration.
With respect to claim 11, the vial is structurally capable of holding a liquid sample that includes a suspension of blood cells (¶[0057]).
Claims 21 and 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Juliar et al. (US 2002/0185186).
With respect to claims 21 and 22, the reference of Juliar et al. discloses:
A cryovial device (78)(Figs. 6-9) comprising:
a vial (79) (Note: In the absence of further positively recited structure, the disclosed vial is considered to be capable of being used as a “cryovial device”) configured to hold a liquid sample;
an inlet/outlet tube (tubing segment assembly)(54) coupled to the vial and constructed of a weldable polymer (¶[0046]), the inlet/outlet tube having:
a filled configuration in which the inlet/outlet tube is coupled to a source of the liquid sample (Note: This claim limitation is considered a statement of intended use. The inlet/outlet tube (54) is structurally capable of being coupled to a source of liquid sample and therefore meets the limitations of the claim); and
a drained configuration in which the inlet/outlet tube is coupled to a receiving tube (Note: This claim limitation is considered a statement of intended use. The inlet/outlet tube (54) is structurally capable of being coupled to a receiving tube and therefore meets the limitations of the claim); and
a vent tube (52) coupled to the vial (79).
With respect to claim 21, the reference of Juliar et al. discloses the use of luer fittings (¶[0003]-[0004] and Fig. 9 (end of inlet/outlet tube (54)).
With respect to claim 22, the reference of Juliar et al. discloses that the vial includes a closed distal end from the inlet/let outlet tube, the closed end configured to prevent access therethrough to contents of the vial.
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 20 is rejected under 35 U.S.C. 103 as being unpatentable over Juliar et al. (US 2002/0185186) in view of Sokolov et al. (US 2016/0331951).
With respect to claim 20, the reference of Juliar et al. discloses:
A cryovial device (78)(Figs. 6-9) comprising:
a vial (79) (Note: In the absence of further positively recited structure, the disclosed vial is considered to be capable of being used as a “cryovial device”) configured to hold a liquid sample;
an inlet/outlet tube (tubing segment assembly)(54) coupled to the vial and constructed of a weldable polymer (¶[0046]), the inlet/outlet tube having:
a filled configuration in which the inlet/outlet tube is coupled to a source of the liquid sample (Note: This claim limitation is considered a statement of intended use. The inlet/outlet tube (54) is structurally capable of being coupled to a source of liquid sample and therefore meets the limitations of the claim); and
a drained configuration in which the inlet/outlet tube is coupled to a receiving tube (Note: This claim limitation is considered a statement of intended use. The inlet/outlet tube (54) is structurally capable of being coupled to a receiving tube and therefore meets the limitations of the claim); and
a vent tube (52) coupled to the vial (79).
While the reference of Juliar et al. discloses the use of tube sets (54) (¶[0002]-[0007], [0024]-[0025] and [0068], the reference is silent with respect to the presence of a spool.
The reference of Sokolov et al. discloses that it is known in the art to employ spool devices to keep tubing from unwinding (¶[0079].
In view of this teaching and in the absence of a showing of unexpected results, it would have been obvious to one of ordinary skill in the art to provide the device of the reference of Juliar et al. with a spool structure to keep any excessive lengths of tubing in an orderly configuration as suggested by the reference of Sokolov et al.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Juliar et al. (US 2002/0185186) in view of Osborn et al. (US 2013/0269825).
With respect to claim 23, the reference of Juliar et al. discloses:
A cryovial device (78)(Figs. 6-9) comprising:
a vial (79) (Note: In the absence of further positively recited structure, the disclosed vial is considered to be capable of being used as a “cryovial device”) configured to hold a liquid sample;
an inlet/outlet tube (tubing segment assembly)(54) coupled to the vial and constructed of a weldable polymer (¶[0046]), the inlet/outlet tube having:
a filled configuration in which the inlet/outlet tube is coupled to a source of the liquid sample (Note: This claim limitation is considered a statement of intended use. The inlet/outlet tube (54) is structurally capable of being coupled to a source of liquid sample and therefore meets the limitations of the claim); and
a drained configuration in which the inlet/outlet tube is coupled to a receiving tube (Note: This claim limitation is considered a statement of intended use. The inlet/outlet tube (54) is structurally capable of being coupled to a receiving tube and therefore meets the limitations of the claim); and
a vent tube (52) coupled to the vial (79).
While the reference of Juliar et al. discloses the use of tube segments (52, 54) coupled to the vial (79), claim 23 differs by reciting that the device includes a tube clip to support and stabilize the tube segments.
The reference of Osborn et al. discloses that it is known in the art to employ a tube clip (Fig. 4) for supporting and stabilizing tube segments coupled vials.
In view of this teaching and in the absence of a showing of unexpected results, it would have been obvious to one of ordinary skill in the art to provide the device of the reference of Juliar et al. with tube clip structure to for the known and expected result of supporting and stabilizing tube segments that are coupled to the vial.
Response to Arguments
With respect to the rejection of Claims 1-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Woods (US 2014/0170634), Applicants are of the position that the rejection of the claims is improper because the reference of Woods does not disclose or suggest, e.g., an inlet/outlet tube having a drained configuration in which the inlet/outlet tube is coupled to a receiving tube (pages 7-8 of the response dated 11/25/25).
In response, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In view of the current claim language, the cryovial device of instant claim 1 includes a vial, an inlet/outlet tube and a vent tube. The reference of Woods discloses the same structural elements. The fact that the device of claim 1 can have different configurations or is intended to be used in a different manner does not further limit the structure of the device. The structure of the device of Woods is capable of being used in the same manner intended by the additional functional language of claim 1.
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 WILLIAM H BEISNER whose telephone number is (571)272-1269. The examiner can normally be reached on Mon-Fri from 8am to 5pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, MICHAEL A MARCHESCHI, can be reached at telephone number (571)272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/William H. Beisner/
Primary Examiner
Art Unit 1799
WHB