The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-14 is/are rejected under 35 U.S.C. 102(a2) as being anticipated by Fabian’396 (US 20060241396)
Fabian’396 teaches
1. A surgical sponge comprising:
an absorbent body (of sponge 32);
a Radio Frequency Identification (RFID) identifier 31 attached to the absorbent body;
an Electronic Article Surveillance (EAS) identifier 35 attached to the absorbent body;
wherein the RFID and EAS identifiers are separate from each other (Fig. 3, paragraphs 65-66),
wherein the RFID identifier and the EAS identifiers have substantially different modes of failure causation (different tags made using different technologies thus the failures occur due to nonconformance to the respective technology or manufacturing defects)
2.1, wherein the RFID identifier is UHF (paragraph 59).
3.1, wherein the RFID identifier is HF (paragraph 59).
4.1, wherein the RFID identifier is operable to communicate a unique alpha-numeric data string corresponding to the respective sponge (paragraph 56).
5.1, wherein the EAS identifier is magnetic or magneto-harmonic (paragraph 57: marker disclosed in 4,510,489 is magneto-harmonic).
6.1, wherein the EAS identifier is acousto-magnetic or magnetostrictive (paragraph 40).
7.1, wherein the EAS identifier is radio frequency or low frequency (paragraph 40, 57).
8.1, wherein the EAS identifier is microwave (par. 12-13, 38, 53).
9.1, wherein the RFID identifier and the EAS identifier are operably separated from each other (Fig. 3).
10.1, further comprising a tag, wherein the RFID identifier and the EAS identifier are geographically spaced apart from one another on the tag or the sponge (Fig. 3).
11.1, wherein the RFID identifier and the EAS identifier are operating at frequencies that are separated from each other (paragraph 16, 73).
12.1, wherein the RFID identifier and the EAS identifier are temporally interrogated at times that are separated from each other (paragraphs 74-75).
13.1, wherein the RFID identifier and the EAS identifiers have substantially different modes of failure causation which leads to a combined failure rate that approximates the failure rate of the RFID identifier multiplied by the failure rate of the EAS identifier (see discussion regarding claim 1 above; moreover, “While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function”, In re Schreiber, 128 F.3d 1473, 1477-78, 44 USPQ2d 1429, 1431-32 (Fed. Cir. 1997) )
14.13, wherein the combined failure rate of the RFID and the EAS identifiers is approximately two orders of magnitude more reliable than the failure rate of the RFID identifier or the EAS identifier individually (see discussion regarding claims above)
Claim(s) 15-20 is/are rejected under 35 U.S.C. 102(a1) as being anticipated by Dein (US 20090317002)
Dein teaches
15. A surgical sponge counting and detection system for counting and detecting surgical sponges for use in the treatment of a patient, the system comprising:
a Radio Frequency Identification (RFID) scanner adapted to detect entry and exit of a surgical sponge RFID identifier associated with each of a plurality of surgical sponges; an Electronic Article Surveillance (EAS) scanner adapted to detect the presence of a surgical sponge EAS identifier associated with each of a plurality of surgical sponges; (par. 81)
a display unit (1550) for indicating information regarding the surgical sponges; and
a control circuit (1510) operably coupled to the RFID scanner, the EAS scanner, and the display unit, wherein the control circuit is configured to determine, based on the scan data from the RFID scanner (Fig. 15),
if the number of sponges entry scanned is equal to the number of sponges exit scanned, and to further determine, based on the scan data from the EAS scanner, if any sponges remain in the patient, further wherein the control circuit is configured to provide an indication, via the display unit, that all the sponges have been removed from the patient, or that one or more sponges still remain in the patient (Dein, Fig. 18, par. 106-107, 124, 146: inbound and outbound sponges are tracked to avoid surgical items in the body).
16.15, wherein the RFID scanner is configured to interrogate a plurality of identification tagged sponges having an RFID identifier thereon, said scanner detecting each of the plurality of tagged sponges electromagnetically, said scanner detecting unique data strings corresponding to each of the plurality of tagged sponges (par. 72-73, 81-82, 106).
17.15, wherein the EAS scanner is configured to interrogate the identification tagged surgical sponges having an EAS identifier thereon (par. 81).
18.16, wherein the RFID scanner is configured to interrogate the plurality of RFID identification tagged sponges that are simultaneously present within a volume, the scanner simultaneously reading the plurality of tagged sponges present in the volume (par. 81, 104: “an inductive detector can also simultaneously or nearly simultaneously detect all of the unique identifiers on all of the surgical items, when the surgical items are in sufficiently close proximity to allow inductive detection”.
19.16, wherein the RFID scanner is configured to interrogate the plurality of RFID identification tagged sponges as they enter the surgical field to establish an accurate count and specific sponge identification and to re-interrogate the plurality of RFID identification tagged sponges later as the same sponges exit the surgical field, to verify that all sponges entering the surgical field are documented as having exited the surgical field and are placed in the sponge disposal bucket (Fig. 12-18).
Re claim 20, see discussion regarding claims above. Dein further teaches that a surgical item such as a sponge can have multiple same identifiers or different identifiers, which include RFID and EAS (Dein, par. 2, 76, 80, 97, 104, 107-108)
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THIEN MAI whose telephone number is (571)272-8283. The examiner can normally be reached on M-F 8-5pm.
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/Thien T Mai/
Primary Examiner, Art Unit 2887