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 .
Receipt is acknowledged of IDS filed on 06/24/2025.
Claims 1-20 are presented for examination.
This application is a CON of 18/527,260 filed on 12/02/2023 now PAT 12,257,585 which is a CON of 16/809,512 filed on 03/04/2020 now PAT 11,833,518 which has PRO 62/869,419 filed on 07/01/2019 which has PRO 62/813,485 filed on 03/04/2019.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,257,585 (hereinafter referred as '585). Although the claims at issue are not identical, they are not patentably distinct from each other because all the claims are expressly found in the claimed application. For instance, claim 1 of the present application recites the following limitations:
A kit for collecting a biological sample, the kit comprising a sample collection device and one or more other components, wherein the one or more other components comprise one or more identification labels, wherein the one or more identification labels each comprise one or more machine-readable codes with unique identification characteristics on one side and an adhesive on the other side.
Whereas claim 1 of '585 application, the applicant claims:
A kit for collecting a biological sample, the kit comprising: one or more identification labels, a sample collection device, one or more sample containers, each of the one or more sample containers comprise a container and a lid, and a collecting pouch; each of the one or more identification labels comprising one or more machine-readable codes with unique identification characteristics on one side and an adhesive on the other side; the sample collection device being configured to collect the biological sample from a sample source and dispense the biological sample into the one or more sample containers; each of the one or more sample containers being configured to receive therein the biological sample dispensed from the sample collection device; and the collecting pouch configured to secure the one or more sample containers for transportation; and wherein the sample collection device contains the one or more identification labels, the one or more sample containers and the collecting pouch within the sample collection device, the sample collection device configured with a removable seal that prevents access and removal of the one or more identification labels, the one or more sample containers, and the collecting pouch contained therein until the removable seal is pulled off.
The instant claims obviously encompass the claimed invention of '585 patent and differ only by terminology. To the extent that the present claims are broader to the claimed invention of '585 patent, In re Goodman 29 USPQ 2d 2010 CAFC 1993.
The obviousness-type double patenting rejection is a judicially established doctrine based upon public policy and is primarily intended to prevent prolongation of the application term by prohibiting claims in a second application not patentably distinct from claims of a first application. In re Vogel, 164 USPQ 619 (CCPA 1970).
Claims 2-15 are also rejected under double patent as being dependent of claim 1.
Claim 16 is rejected under double patent in view of claim 11 of '585 patent.
Claims 17-19 are also rejected under double patent as being dependent of claim 16.
Claim Rejections - 35 USC § 102
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.
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.
Claim(s) 1-2, 5-7, 9-17 and 19-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Halpern et al. (US 2011/0281346).
Re Claims 1 and 16: Halpern et al. {hereinafter referred as “Halpern”} teaches donated blood collection kit, a sample collection device {herein kit 200} and one or more other components (see fig.# 2-4), wherein the one or more other components comprise one or more identification labels {herein the test tubes 106/110/113/116/120} (see fig.# 1), wherein the one or more identification labels each comprise one or more machine-readable codes {herein barcodes 140/143/146/150} with unique identification characteristics on one side and an adhesive on the other side (¶ 36+). Halpern also teaches a sealing flap {herein not shown} (¶ 38+).
Re Claim 2: Halpern teaches device and method, wherein the sample collection device serves as a container {herein blood container 123} for the one or more other components (¶ 36+).
Re Claim 5: Halpern teaches device and method, wherein the machine-readable code comprises a bar code, a matrix code or two-dimensional bar code, a radio frequency identification (RFID), a magnetic strip, a microchip, or an optical character recognition (OCR) (¶ 36+).
Re Claim 6: Halpern teaches device and method, wherein the one or more other components comprise one or more sample containers, the one or more sample containers each comprising a container and a lid {herein cover 300} (¶ 38+).
Re Claim 7: Halpern teaches device and method, wherein each of the one or more identification labels 303 is integrated onto the lid 300 (¶ 39+).
Re Claim 9: Halpern teaches device and method, wherein the kit comprises one to five sample containers (see fig.# 1).
Re Claims 10 and 17: Halpern teaches device and method, wherein the one or more other components comprise a collecting pouch {herein a collection bag} (¶ 9-11, 31+).
Re Claims 11-12: Halpern teaches device and method, wherein the one or more other components comprise instructions, wherein the instructions pertain to the use of the components comprising kit for the collection of a biological sample and/or pertain to the collection and transportation of a biological sample obtained from a donor (¶ 46-48+).
Re Claim 13: Halpern teaches device and method, wherein the one or more other components comprise a cleaning wipe (¶ 13+).
Re Claims 14 and 19: Halpern teaches device and method, wherein the sample is collected from an individual, an apparatus, a location {herein facility},or any combination thereof (¶ 40+).
Re Claims 15 and 20: Halpern teaches device and method, wherein the sample is a biological sample {herein blood},anon-biological sample, or both (¶ 9+).
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 (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.
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.
Claim(s) 3-4 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Halpern et al. (US 2011/0281346) in view of Bruno et al. (US 2016/0354775).
The teachings of Halpern have been discussed above.
Halpern fails to specifically teach the sample collection device has a cylindrical cup- shaped design with a capacity to hold between 100 ml to 400 ml or 200 ml to 250 ml.
Bruno et al. teaches leak proof, air tight plastic container device, which includes collection with a capacity to hold between 100 ml to 400 ml or 200 ml to 250 ml (¶ 21-254).
In view of Bruno et al.’s teachings, it would have been obvious to an artisan of ordinary skill before the effective filing date of the claimed invention was made to employ into the teachings of Halpern a capacity to hold between 100 ml to 400 ml or 200 ml to 250 ml so as to accommodate a certain volume of the collected sample within the kit for transportation.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Halpern et al. (US 2011/0281346) in view of Ingber et al. (CA 2892950 C).
The teachings of Halpern have been discussed above. Halpern further teaches that the housing 203 and cover 300 may be made of any suitable material (see ¶ 37+).
Halpern fails to specifically teach the one or more sample containers is a flat sheet of aluminum.
Ingber et al. teaches optics cup with curved bottom, wherein the one or more sample containers is a flat sheet of aluminum (see ¶ 42+).
In view Ingber et al.’s teachings, it would have been obvious to an artisan of ordinary skill before the effective filing date of the claimed invention was made to employ into the teachings of Halpern the one or more sample containers is a flat sheet of aluminum so as to provide a strengthened enclosure for the housing of the kit.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Graves (US 2008/0265029) teaches method and apparatus for verifying contents of containers marked with machine-readable identifiers.
Provencher et al. (US 2016/0015598) teaches biological sample containment system and label.
Wilkinson (US 2006/0091669) teaches label system with fill line indicator.
Dittmann et al. (US 6,659,338) teaches method and device for withdrawing biological samples.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EDWYN LABAZE whose telephone number is (571)272-2395. The examiner can normally be reached 8:30AM-5:00PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mr. STEVE PAIK can be reached at 571-272-2404. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EDWYN LABAZE/Primary Examiner, Art Unit 2876