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 .
Information Disclosure Statement
The information disclosure statement(s) (IDSs) submitted on 12/23/24 is/are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement(s) is/are being considered by the examiner, but where the documents in the IDS(s) will be considered in the same manner as other documents in Office search files while conducting a search of the prior art in a proper field of search.
Status of the Application
This application has priority to US 63/356788, filed 6/29/22, and is a 371 of PCT/US2023/069323, filed 6/29/23.
Status of the Claims
Claims 1-6, 8-13, 16-20, 22-23, and 27 are pending in the application and under consideration.
Claim Rejections - 35 USC § 103 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 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. 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for ‘establishing a background for determining obviousness under 35 U.S.C. 103(a) 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 under 35 U.S.C. 103, the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103 and potential 35 U.S.C. 102(a)(2) prior art under 35 U.S.C. 103. Claims 1-6, 8-13, 16-20, 22-23, and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Goodman (US 2008/0208158 A1).
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As to claim 1, Goodman teaches a packaging and transporting device for a biological sample (as kits for collection and shipping of medical samples/tissue having 1st and 2nd insulating containers [0013] as 1st and 2nd boxes Fig.1; [0027]; [0002]), the packaging and transporting device comprising:
an insert (inserts shown in Fig.1 annotated above for tissue/sample containers 6,8,9,10; [0022],ll.4-8);
a securing strip/securing element 3 (lid 3 placed on top of sample containers 6-9 securing sample containers in place Fig.1; [0022],ll.3-7; where making separable two or more elements in the prior art where the combined elements perform the same function involves only routine skill in the art MPEP 2144.04(V)C );
a temperature sensor (as inside temperature sensor and device that informs user of temperature within the device [0042]), wherein the insert comprises a plurality of cavities/trays/inserts sized and shaped to receive the securing strip 3, the securing element 3, and the temperature sensor (as shown in Fig.1 annotated above where inserts provided with cavities/trays/inserts for tissue/sample containers 6,8,9,10; [0022],ll.4-8); sensor provided [0042])
a plurality of labels, wherein at least one of the plurality of labels includes patient information (bar code labels for collection bags [0046],ll.5; such as identification bar code labels [0119]);
a shipping pouch sized and shaped to receive a shipping document (shipping label [0082]; as pouch (as necessary for) shipping label for shipping sample container [0027],ll.3-4,22-24); and
a transport bag 10 configured to receive a sample container (plastic bag for holding tissue sample for shipping tissue sample such as sample container 6,8,9 [0022],ll.4-8).
Goodman does not specifically teach that the insert 3 comprises a plurality of cut-outs. However, it would have been obvious to one of ordinary skill to replace the cavities/inserts/trays of Goodman with cut-outs as claimed, and one of skill would have been motivated to do so, wherein either the trays, cavities, and/or inserts would include the use of cutouts, where no further distinguishing features of the cutouts are recited.
As to claim 2, Goodman teaches wherein the plurality of cut outs includes a first cut out, a second cut out, and a third cut out (as two or more, as presented above, as obvious over the use of the trays, cavities, and/or inserts holding one or more kit contents, e.g., [0030],ll.18-19).
As to claims 3-5, Goodman teaches wherein: the first cut out of the insert is configured to receive and store the securing strip, the second cut out of the insert is configured to receive and store the temperature sensor, and the third cut out of the insert is configured to receive and store the securing element; the insert is disposed between the transport bag and the plurality of labels; and the insert is disposed between the transport bag and the plurality of labels, and the transport bag is disposed between the shipping pouch and the insert (as two or more trays, cavities, and/or inserts, as presented above, as holding one or more kit contents, e.g., [0030],ll.18-19; and/or where arrangement of parts is not relevant for patentability unless they provide unexpected results or other indicia of patentability).
As to claim 6, Goodman teaches wherein the device further comprises:
an inner shipping container 1 sized and shaped to receive the transport bag and a cooling engine 2, wherein the inner shipping container is smaller in size than the packaging and transporting device (Fig.1; [0022],ll.2-3).
As to claims 8-9 and 11-13, Goodman teaches wherein: the securing strips/elements 3 (as presented above for claim 1) are: (8) configured to leave a mark on the inner shipping container if removed or altered (where removal of lid 3 from top of container 1 would cause at least some type of mark due to compression of material, e.g., Styrofoam™ or foam [0023],ll.8-9); (9) disposed within one of the plurality of cut outs of the insert; (11) disposed within the plurality of cut outs of the insert; and (13) disposed with cutouts (where Goodman teaches obvious equivalent of cut-outs as cavities/trays/inserts for tissue/sample containers 6,8,9,10; [0022],ll.4-8, as presented above for claim 1); (12) as 4 or more (where duplication of parts does not impart patentability);
As to claim 10, Goodman teaches wherein the inserts (Fig.1 annotated above per claim 1) include 4 or more inserts (for each of tissue containers 7/8/8/8 Fig.1).
As to claim 16, Goodman teaches wherein the device further comprises:
a cooling engine (temperature controlling composition [0019]) configured to maintain a temperature range of approximately -80°C to approximately 10°C upon activation of the cooling engine (maintained at -20C to 10C, substantially within the claimed range [0094],ll.4-10).
As to claim 17, Goodman teaches wherein the transport bag includes an absorbent sheet (absorbent pad, gauze) configured to absorb leakage of the sample container ([0046],ll.6-7).
As to claim 18, Goodman teaches wherein the packaging and transporting device includes two or more labels (labels, bar code labels [0046],ll.5).
As to claim 19, Goodman teaches wherein the temperature sensor is disposed within one of the a plurality of cavities/trays/inserts sized and shaped to receive the temperature sensor (as shown in Fig.1 annotated above where inserts provided with cavities/trays/inserts for tissue/sample containers 6,8,9,10; [0022],ll.4-8); sensor provided [0042]).
Goodman does not specifically teach that the temperature sensor ([0042], as presented above) provided in the insert comprises a plurality of cut-outs. However, it would have been obvious to one of ordinary skill to replace the cavities/inserts/trays of Goodman with cut-outs as claimed, and one of skill would have been motivated to do so, wherein either the trays, cavities, and/or inserts would include the use of cutouts, where no further distinguishing features of the cutouts are recited.
As to claim 20, Goodman teaches wherein the transport bag is configured to withstand up to 95 kPa without leaking (where shipping/transport bag is rated to withstand 95kPa of pressure [0037],ll.4-8).
As to claim 22, Goodman teaches wherein the insert 3 (Fig.1 annotated above as presented in claim 1) is disposed between the plurality of labels and one of the shipping pouch and the transport bag (pouch as necessary for shipping label for shipping sample container [0027],ll.3-4,22-24) (where rearranging of parts only requires routine skill in the art MPEP 2144.04(I)C).
As to claim 23, Goodman teaches wherein the device further comprises:
kit container 1 housing (Fig.1 annotated above): the insert 2, the plurality of labels [0046], the shipping pouch (pouch as necessary for shipping label for shipping sample container [0027],ll.3-4,22-24), and the transport bag (plastic bag for holding tissue sample for shipping tissue sample such as sample container 6,8,9 [0022],ll.4-8).
As to claim 27, Goodman teaches a method for packaging a biological sample, the method comprising: providing a packaging kit having a transport bag and an insert storing a securing element, a securing strip, and a temperature sensor;
securing a sample container with the securing element, wherein the sample container includes the biological sample;
applying a first label to the secured sample container, the first label including at least one of patient information;
inserting the labeled sample container into the transport bag;
placing the transport bag into an inner shipping container, wherein the inner shipping container comprises a cooling engine and the temperature sensor;
closing the inner shipping container such that the transport bag, the cooling engine, and the temperature sensor are disposed within the inner shipping container;
securing the inner shipping container in a closed position using the securing strip such that attempted access to an interior of the inner shipping container is evident; and applying a second label to the inner shipping container, the second label including at least one of patient information and destination information [[as obvious over Goodman as presented above for claims 1-6, 8-13, 16-20, and 22-23 ]].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure. The references provided on the attached PTO Form 892 are considered relevant to Applicants’ disclosure and are cited to show further the general state of the art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to: GUY K. TOWNSEND whose telephone number is (571) 270-3689. The examiner can normally be reached Mon. - Fri., 11 am to 6 pm Eastern Time. The direct fax number is (571) 270-4689.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, REBECCA EISENBERG, can be reached on 571-270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/GUY K TOWNSEND/Primary Examiner, Art Unit 3781
