DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 23 December 2025 has been entered.
Priority
As noted in the office action mailed 18 September 2024, the effective filing date for the instant claims is 02 September 2021. This is the filing date of parent application no. 17/465,322. Although this application is a CIP of application no. 16/542,050, application no. 16/542,050 does not contain support for cooling media pouches configured as a band that is wrapped around a cylindrical sample storage chamber in communication with outer cooling media pouches.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. However, the Figures do not appear to show:
a band of cooling media pouches, wherein the band of cooling media pouches is configured to wrap around the cylindrical sample storage chamber such that the band of cooling media pouches is directly in contact with a circumference of the cylindrical sample storage chamber and outer cooling media pouches layered circumferentially around the band of cooling media pouches.
Therefore, this feature must be shown or canceled from the claims. No new matter should be entered.
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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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 § 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 17-21, 25-31, 35 and 36-38 are rejected under 35 U.S.C. 103 as being unpatentable over O’Dell (US 5362622) in view of Haarmann (US 20120266564) and Lee (US 20200002075).
With respect to claims 17 and 27, O’Dell discloses a system and method for transporting biological materials. O’Dell teaches that an insulated vessel (“constructed of a material having a high insulative index, such as styrofoam”) comprising a lid (Figure 9:114) and housing (Figure 9:94) is provided, wherein the housing defines a first cavity (Figure 9:96), and wherein the lid is configured to be movable. A rigid cylindrical sample storage chamber (Figure 10:98) is configured to be positioned within the first cavity and/or removed from the first cavity when the lid is moved to an open configuration. A plurality of cooling media pouches (Figure 10:106) are placed around the cylindrical sample storage chamber to maintain a stable temperature. This is taught in column 8, line 34 to column 9, line 14. O’Dell, however, does not appear to teach that the cooling media pouches are coupled to form a band that wraps around the cylindrical sample storage chamber.
Haarmann discloses a plurality of cooling media pouches (Figure 2:12) configured to maintain a stable temperature during the transportation and storage of a blood sample. Paragraph [0029] states that the pouches are coupled together using a flexible intermediate portion (Figure 2:16). Haarmann expressly recommends directly contacting a container for holding biological material with the cooling media pouches (“In operation, a blood bag is placed on first compartment 12 and second compartment 14 is folded over the blood bag”).
Lee discloses a transport apparatus comprising an insulated vessel (Figure 1:13) having a lid (Figure 1:95) and a vessel housing (Figure 1:23). The vessel housing defines a first cavity and a lid, and a storage chamber (Figure 1:61) is positioned within the first cavity and is configured to be removed when the lid is in an open configuration. Lee teaches that a band of cooling media pouches (Figure 1:71-1 to 71-4) is configured to wrap around the sample storage chamber so that the cooling media pouches are directly in contact with a circumference of the storage chamber. Outer cooling media pouches (Figure 1:91-1 to 91-3) are layered circumferentially around the band of cooling media pouches to further control the temperature of the sample storage chamber. This is taught in paragraphs [0080]-[0090].
Before the effective filing date of the claimed invention, it would have been obvious to ensure that the O’Dell cooling media pouches are coupled together and directly wrapped and curved around the external surface of the cylindrical sample storage chamber. Haarmann teaches that this is easily and effectively accomplished using a flexible PCM pouches. Haarmann discusses the use of other types of “flexible fasteners made of rubber or a material which can be bent to hold the [cooling media pouches] in a desired configuration and then hold the [cooling media pouches] in that position, e.g., wire”, and therefore one of ordinary skill would have recognized that the O’Dell pouches could readily be coupled together using a variety of different flexible connection means. Lee similarly shows how flexible cooling pouches are wrapped and curved around a target in direct contact with the target to effectively maintain the temperature of the target over a period of time. Lee teaches that multiple layers of temperature control pouches may be radially oriented so that the pouches offer additional reinforced control over temperature. Lee expressly states in paragraph [0090] that it is well within the ability of one of ordinary skill to optimize and experiment with the position, size and pattern of a plurality of cooling media pouches used in a sample transport apparatus.
With respect to claims 18 and 28, O’Dell, Haarmann and Lee disclose the combination as described above. Haarmann further teaches that the cooling media pouches comprise eutectic cooling blocks. See, for example, paragraphs [0029]-[0032].
With respect to claims 19 and 29, O’Dell, Haarmann and Lee disclose the combination as described above. O’Dell teaches throughout the reference that the biological sample may be a tissue or an organ (Figure 1:18).
With respect to claims 20, 21, 30 and 31, O’Dell, Haarmann and Wen Lee green disclose the combination as described above. O’Dell further states in column 3, lines 57-61 that the temperature within the cylindrical sample storage chamber is maintained at 4°C.
With respect to claims 25, 26, 35 and 36, O’Dell, Haarmann and Lee disclose the combination as described above. As noted above, Haarmann shows how the cooling media pouches 12 are joined side by side using the intermediate portion 16. See also Figs. 18, 26 and 34 of Lee. O’Dell shows 8 cooling media pouches 106 in Fig. 10.
With respect to claims 37 and 38, O’Dell, Haarmann and Lee disclose the combination as described above. O’Dell further shows that the sample storage chamber includes a port (Figure 1:38) configured to purge gas from the cylindrical sample storage chamber (“gas from the perfusate 16, which now has a concentration of carbon dioxide expelled from tissue 18, permeates membrane 26 into pumping compartment 29, where it is expelled through lid port 42 and in turn through gas exhaust port 38”).
Claims 22-24 and 32-34 are rejected under 35 U.S.C. 103 as being unpatentable over O’Dell (US 5362622) in view of Haarmann (US 20120266564) and Lee (US 20200002075) as applied to claims 17 and 27, and further in view of Owen (US 20040058432).
O’Dell, Haarmann and Lee disclose the combination as described above, however do not expressly describe the use of a basket, temperature sensors and a digital display.
Owen discloses a method for the hypothermic transport of an organ within a transport container (generally, Figure 23:1900). The organ is placed in the interior of the container (see also Figure 2:40) using a basket (Figure 2:65). This is shown in Figs. 11A-11D. A removable lid (Figure 11D:67d) is operable to couple with walls to form a sterile environment within the sample storage chamber. Paragraphs [0105] and [0166] state that a temperature sensor (Figure 2:T1, T2) is provided within the sterile environment. The sensor is in communication with a display (Figure 1:5c) that is readable outside the sterile environment without opening the removable lid. Owen also describes that a cooling media (Figure 21:2110) is used to maintain a stable temperature within the sterile environment.
Before the effective filing date of the claimed invention, it would have been obvious to modify O’Dell to include standard organ transport features, including a basket, temperature sensors and a digital display. As evidenced by Owen, the provision of a basket would have stabilized the organ when the insulated vessel is shaken or vibrated during transportation. Owen further states that baskets generally include soft and elastic materials that are compatible with organ/tissue handling. Furthermore, those of ordinary skill would have recognized the value of providing common temperature control means, such as sensors and displays, especially given that O’Dell already recognizes the importance of maintaining a desired temperature suitable for organ preservation.
Response to Arguments
In response to Applicant’s amendment, the previous rejection under 35 U.S.C. 112 has been withdrawn.
Applicant’s remarks regarding the objection to the Drawings are not persuasive. Applicant asserts that the configuration of the claimed cooling media pouches is a new and patentable improvement. It stands to reason, therefore, that Figures representing and showing this inventive feature are necessary for understanding the innovative subject matter. Any structural detail that is of sufficient importance to be described should be shown in the drawing. (Ex parte Good, 1911 C.D. 43, 164 OG 739 (Comm’r Pat. 1911).)
In response to Applicant’s amendment filed 23 December 2025, the previous rejection under 35 U.S.C. 103 has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of the combination of O’Dell with Haarmann and Lee.
Conclusion
This is a non-final rejection.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATHAN ANDREW BOWERS whose telephone number is (571)272-8613. The examiner can normally be reached M-F 7am-5pm.
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/NATHAN A BOWERS/Primary Examiner, Art Unit 1799