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.
Information Disclosure Statement
The information disclosure statement dated 8/28/2025 has been considered and made of record.
Claim Objections
Claim 2 is objected to because of the following informalities: At line 4, “the sensor” should be “the sensor system”. Appropriate correction is required.
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.
Claims 1-11 and 15-22 are rejected under 35 U.S.C. 103 as being unpatentable over Smith et al. (US 2020/0155126) in view of Jin et al. (CN 102167182 and corresponding machine translation).
With respect to claim 1, the reference of Smith et al. discloses:
An environmental control system for transportation of a semen sample (1, 100, 200)(Figs. 1-6), the system comprising:
a sample container (100), configured to contain a semen sample (¶[0021]);
an environmental control element (231, 232) configured to operate within an optimal temperature range for semen viability (¶[0004] and [0019]), wherein the environmental control element comprises a phase transition material (A phase change material is preferably disposed in phase change material bottles 231 and 232, and the selected phase change material may be a commercially available phase change material, including but not limited to a functionalized bioPCM, an inorganic material, an organic material, a eutectic material) (¶[0004] and [0019]) configured to go through a phase change within the optimal temperature range (a temperature of less than or equal to 72° F, a temperature in the range of 68-72° F, desired temperature range is between about 2 to 8 degrees Centigrade)(¶[0004] and [0019]).
Claim 1 differs by reciting that the system is also for monitoring the sample and includes:
a sensor system for monitoring an environmental condition of the sample container,
wherein the sensor system is in thermal contact with at least one of the sample container or the environmental control element.
The reference of Jin et al. discloses that it is known in the art, when transporting a biological sample (including semen)(¶[0001] of the translation), to provide the environmental control system with a sensor system (temperature sensor)(530)(humidity sensor)(540) for monitoring an environmental condition of the sample container,
wherein the sensor system is in thermal contact with at least one of the sample container (400) or the environmental control element (300).
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 system of the primary reference of Smith et al. with a sensor system as suggested by the reference of Jin et al. for the known and expected result of monitoring and logging the environmental conditions within the transport container to ensure the integrity of the biological sample during transport of the sample.
With respect to claims 2 and 3, the system of Smith et al. includes a positioning retainer (trays)(251 and 252) for restraining movement of the sample container (100), the environmental control element (231 and 232), and the sensor relative to one another. Note: In the absence of further positively recited structure, the trays (251 and 252) are considered to meet the structure of a packing material.
With respect to claim 4, the structure resulting from the combination of the references as discussed above with respect to claim 1 would encompass a structure that includes a sensor for measuring the environmental condition (temperature sensor)(530)(humidity sensor)(540); a data store in electronic communication with the sensor (storing module)(560), wherein the data store is configured to store measurements from the sensor (¶[0017] of the translation); and a data port (communication interface)(¶[0008] of the translation) in electronic communication with the data store.
With respect to claim 5, the sensor is a temperature sensor (530).
With respect to claim 6, the sensor is a humidity sensor (540).
With respect to claim 7, in the absence of a showing of unexpected results, it would have been obvious to one of ordinary skill in the art to determine the optimum frequency in which to monitor the environmental conditions through routine experimentation.
With respect to claim 8, the measurements from the sensor system are stored on the data store (¶[0008]-[0009], [0016] and [0017] of the translation).
With respect to claims 9 and 10, the data port electronically communicates measurements from the sensor system to a remote server and the measurements are stored on the data store prior to being transmitted to the remote server (900)(¶[0008]-[0009], [0016] and [0017] of the translation).
With respect to claim 11, the remote server comprises: a server data port for sending and receiving data, wherein the data comprises the measurements; a server data store in electronic communication with the server data port for storing the data; and a sever processor for analyzing the data (¶[0008]-[0009], [0016] and [0017] of the translation).
With respect to claim 15, the reference of Smith et al. discloses a container wall (211, 212) surrounding an internal cavity, wherein the positioning retainer fits (251, 252) within the internal cavity, wherein the cavity is surrounded by the container wall.
With respect to claim 16, the reference of Smith et al. discloses that the sample container can include a semen preservation solution (¶[0016]).
With respect to claim 17, the data port and the server data port each comprise a wireless adaptor (¶[0008]-[0009], [0016] and [0017] of the translation).
With respect to claims 18 and 19, in the absence of a showing of further positively recited structure the temperature sensor (530) of Jin et al. is considered to meet the claim language of a temperature indicator that can display a level of exposure.
With respect to claims 20-22, while the structure resulting from the combination of the references with respect to claim 1 encompasses a system that includes a temperature sensor, the reference of Jin et al. does not specifically disclose the sensor positions as required in claims 20-22.
However, in the absence of a showing of unexpected results, it would have been well within the purview of one having ordinary skill in the art to provide the sensors as various positions within the system for the known and expected result of determining/measuring the temperatures that the various components of the sample transport system is exposed to including external temperature conditions.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Smith et al. (US 2020/0155126) in view of Jin et al. (CN 102167182 and corresponding machine translation) taken further in view of Purdum (US 5,899,088).
The combination of the references of Smith et al. and Jin et al. has been discussed above with respect to claim 1.
While the reference of Smith et al. discloses an optimal temperature range for semen viability (¶[0004] and [0019]), wherein the environmental control element comprises a phase transition material (A phase change material is preferably disposed in phase change material bottles 231 and 232, and the selected phase change material may be a commercially available phase change material, including but not limited to a functionalized bioPCM, an inorganic material, an organic material, a eutectic material) (¶[0004] and [0019]) configured to go through a phase change within the optimal temperature range (a temperature of less than or equal to 72° F, a temperature in the range of 68-72° F, desired temperature range is between about 2 to 8 degrees Centigrade)(¶[0004] and [0019]), the reference does not disclose the specific range required of claim 14.
The reference of Purdum discloses that it is known in the art to customize and maintain a desired temperature range within a shipping container by optimization of known phase change materials to bracket a target temperature range (col. 5, lines 19-64).
In view of this teaching and in the absence of a showing of unexpected results, it would have been well within the purview of one having ordinary skill in the art to determine the optimal desired temperature range during transport of the sample through routine experimentation.
Response to Arguments
Claim Interpretation - 35 USC 112
In view of the amendments to claim 1, the claim element “an environmental control element” is no longer considered to invoke 35 USC 112(f) since the element includes the positively recited structure of “a phase transition material”.
Claim Rejections - 35 USC 112
The rejection of claim 13 under 35 USC 112(b) has been withdrawn since claim 13 has been cancelled.
Claim Rejections - 35 USC 102
The rejection of Claims 1-3, 12-15, 18 and 19 under 35 U.S.C. 102(a)(1) as being anticipated by Chopping et al. (US 2015/0264744) has been withdrawn in view of the amendments to claim 1 and corresponding comments on pages 6-7 of Applicants’ response dated 8/28/2025.
New grounds of rejection have been made over the combination of the references of Smith et al. (US 2020/0155126) in view of Jin et al. (CN 102167182 and corresponding machine translation).
Claim Rejections - 35 USC 103
The rejections of Claims 20-22 under 35 U.S.C. 103 as being unpatentable over Chopping et al. (US 2015/0264744); Claims 4-11 and 17 under 35 U.S.C. 103 as being unpatentable over Chopping et al. (US 2015/0264744) in view of Subbarao et al. (US 2019/0043615); and Claim 16 under 35 U.S.C. 103 as being unpatentable over Chopping et al. (US 2015/0264744) in view of Morgan (US 2002/0165673) have been withdrawn in view of the amendments to claim 1 and corresponding comments on pages 6-9 of Applicants’ response dated 8/28/2025.
New grounds of rejection have been made over the combination of the references of Smith et al. (US 2020/0155126) in view of Jin et al. (CN 102167182 and corresponding machine translation).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
The references of Lejondahl et al. (US 4,862,674); Douglas-Hamilton (US 6,675,605) and Patstone (US 8,887,515) are cited as prior art references which pertains to sample transport containers that include phase change materials.
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