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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 1 page 3 line 1-2: “the RFID tag” lacks antecedent basis.
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.
Claim(s) 1, 4, 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stewart (US 20180285704, paragraphs and Figures cited herein are in the supporting provisional application 62/480965 filed 04/03/2017) in view of Eisenberg (US 20020196126)
1. A system for counting surgical sponges during a surgical procedure, the system comprising:
a scanner (40) including an antenna defining a plane and disposed outside of a sterile field for the surgical procedure (Fig. 8-9, par. 61); and a pack of at least five surgical sponges disposed in the sterile field (par. 55, 58) and secured in an arrangement that is configured to reduce interference between RFID tags attached to the surgical sponges
(Stewart is silent to reducing interference;
Eisenberg discloses a stack of objects onto which RFIDs are attached at the same relative positions or different relative locations such as staggering so that they do not overlap (Fig. 6, par. 45-47). Furthermore, “alternating tags could be inverted or rotated to different degrees to provide the same effect”. Eisenberg discloses by staggering the locations of the RFID tags, inverting or rotating the tag, or diversifying the tag locations or geometries, the interactions among overlapping RFID tags are minimized, Fig. 4, par. 8, 44, 48, 56; furthermore, arrangement of parts, in this case the parts are the folded sponges, has been held as an obvious expedient; see In re Kuhle, 526 F.2d 553, 188 USPQ 7;
it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate known teachings so that the sponges may be folded and arranged in a way that is desirable; therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the known teachings by folding, arranging, and stacking the sponges such that the associated RFID tags being place at opposing corners or at staggered locations from each other in order to minimize interactions or interference among the tags when communicating with a reader); and
enable the scanner to read the RFID tags of all the surgical sponges within the pack from outside of the sterile field while the pack is positioned in the sterile field (Stewart, Fig. 8, par. 61),
each of the surgical sponges comprising:
an absorbent material body including opposed first and second edges (Figs. 1-2, 8), opposed third and fourth edges each intersecting with the first edge and the second edge to define corners of the absorbent material body, and opposed top and bottom surfaces each bounded by the first, second, third, and fourth edges, wherein the absorbent material bodies of the surgical sponges are structurally the same, and
an RFID tag (12) configured to operate in the ultra-high frequency band (Stewart, par. 61) and storing a unique identifier (Stewart, Fig. 7) associated with the surgical sponge, the RFID tag including an elongated side and a coil oriented to extend along the elongated side (Figs. 3-4), the RFID tag being attached to the top surface of the absorbent material body,
wherein the RFID tags of at least a first, a second, and a third of the surgical sponges have a same attachment position and orientation relative to the absorbent material bodies of the first, second, and third surgical sponges, the attachment position being proximate a corner of the absorbent material body defined by the intersection of the first edge and third edge, and the orientation being such that the elongated side of the RFID tag extends along the first edge (Eisenberg, Fig. 6, par. 47, 58: tags are at the same position relative to the sponges and can overlap each other but the tag may be inverted or rotated to avoid tag-tag interaction),
wherein the pack further includes packaging (band(s) 26) securing the surgical sponges in a stack including opposed first and second ends each defined by the top surface or the bottom surface of a different one of the surgical sponges, opposed first and second sides each intersecting the opposed first and second ends, and opposed third and fourth sides each intersecting the opposed first and second ends and the opposed first and second sides, the opposed third and fourth sides of the stack being defined by the opposed third and fourth edges of the surgical sponges, respectively,
wherein the first surgical sponge is positioned between the second and the third surgical sponges within the stack and is vertically flipped about the first edge of the first surgical sponge relative to the second and third surgical sponges such that the top surfaces including the RFID tags of the second and third surgical sponges face the first ends of the stack, the top surface including the RFID tag of the first surgical sponge faces the second end of the stack opposite the first end; the elongated sides of the RFID tags of the second and third surgical sponges each extends along the first side of the stack, and the elongated side of the RFID tag of the first surgical sponge extends along the second side of the stack that is opposite the first side of the stack (Eisenberg, par. 44-47: items can be positioned at different positions relative to each other and a tag’s position on an item is different than the next tag’s position; par. 56: alternating tag can be inverted or rotated; thus, it would have been obvious to one of ordinary skill in the art before the effective date the invention was made to extend Eisenberg’s teachings by inverting or flipping a first sponge that is between a second and third sponges to minimize tag-tag interaction), and
wherein the scanner (40, Fig. 8) is configured to:
while the scanner is positioned outside the sterile field and the pack of surgical sponges is positioned in the sterile field such that the first end of the stack is separated from and faces the plane defined by the antenna of the scanner, read the unique identifiers stored on the RFID tags of all the surgical sponges within the pack and add the unique identifiers to an electronic record associated with the surgical procedure (Stewart, par. 22, 50: “surgical articles will be programmed after having been assembled into the pack”; Eisenberg, Fig. 4, 7: the tags can face plane of reader antenna), and
while the scanner is positioned outside the sterile field and one of the surgical sponges is positioned relative to the scanner following being used in the surgical procedure such that the surgical sponge is separated from the scanner and within the sterile field, read the unique identifier stored on the RFID tag of the one surgical sponge and update the electronic record to indicate presence of the one surgical sponge after use in the surgical procedure based on the unique identifier read from the RFID tag of the one surgical sponge after use in the surgical procedure (Stewart, par. 71-73: after one sponge is removed from a sterile pack and used in a procedure, the used sponge is read by the reader to ensure all sponges are accounted for).
4. 1, wherein the packaging comprises one or more straps 26 bundling the surgical sponges
7.1, comprising an indicator disposed on an outer portion of the packaging at the first end of the stack, the indicator signaling to move the pack of surgical sponges relative to the plane of the scanner while the first end of the stack is facing the scanner (Stewart’674, Fig. 7, c3: 5-11, c5: 35-55, c7: 13-28: optical machine readable as an indicator on the band suggests to the user that the pack of sponges is needed to be moved relative to the scanner with the optical code facing the scanner in order for the scanner to read it effectively).
25.1, wherein the RFID tag of each of a fourth and fifth of the surgical sponges is attached to the absorbent material body of the surgical sponge proximate the third edge and such that the elongated side of the RFID tag extends along the third edge of the surgical sponge, and wherein the packaging secures the second fourth and fifth surgical sponges in the stack with the first, second, and third surgical sponges, such that the fourth surgical sponge is disposed between the first and second surgical sponges, with the top surface including the RFID tag of the fourth surgical sponge facing the first end of the stack and the elongated side of the RFID tag of the fourth surgical sponge extending along the third side of the stack, and such that the fifth surgical sponge is disposed between the first and third surgical sponges, with the fifth surgical sponge being vertically flipped about the first edge relative to the fourth surgical sponge such that the top surface including the RFID tag of the fifth surgical sponge faces the second end of the stack opposite the first end of the stack and the elongated side of the RFID tag of the fifth surgical sponge extends along the third side of the stack (Eisenberg, par. 44-45, 56: a tag can be rotated and repositioned anywhere on the item; thus it would have also been obvious that the tags and/or a fourth and/or a fifth sponges can be rotated or flipped and can be placed anywhere in the pack of sponges to minimize interactions)
29. A method for counting surgical sponges during a surgical procedure, the method comprising:
positioning a scanner (40) including an antenna outside of a sterile field associated with the surgical procedure (Stewart, Fig. 8);
obtaining a pack (24) of at least five surgical sponges, the surgical sponges of the pack secured in an arrangement that is configured to reduce interference between RFID tags attached to the surgical sponges and enable the scanner to read the RFID tags of all the surgical sponges within the pack from outside of the sterile field while the pack is positioned in the sterile field .
(Stewart is silent to reducing interference;
Eisenberg discloses a stack of objects onto which RFIDs are attached at the same relative positions or different relative locations such as staggering so that they do not overlap (Fig. 6, par. 45-47). Furthermore, “alternating tags could be inverted or rotated to different degrees to provide the same effect”. Eisenberg discloses by staggering the locations of the RFID tags, inverting or rotating the tag, or diversifying the tag locations or geometries, the interactions among overlapping RFID tags are minimized, Fig. 4, par. 8, 44, 48, 56; furthermore, arrangement of parts, in this case the parts are the folded sponges, has been held as an obvious expedient; see In re Kuhle, 526 F.2d 553, 188 USPQ 7;
it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate known teachings so that the sponges may be folded and arranged in a way that is desirable; therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the known teachings by folding, arranging, and stacking the sponges such that the associated RFID tags being place at opposing corners or at staggered locations from each other in order to minimize interactions or interference among the tags when communicating with a reader), wherein each of the surgical sponges comprises:
an absorbent material body including opposed first and second edges (Figs. 1-2, 8), opposed third and fourth edges each intersecting with the first edge to define corners of the absorbent material body, and opposed top and bottom surfaces each bounded by the first, second, third, and fourth edges, wherein the absorbent material bodies of the surgical sponges are structurally the same; and
an RFID tag (12) configured to operate in the ultrahigh frequency band and storing a unique identifier associated with the surgical sponge, the RFID tag including an elongated side and a coil oriented to extend along the elongated side (Figs. 3-4), the RFID tag being attached to the top surface of the absorbent material body, wherein the RFID tags of at least a first, a second, and a third of the surgical sponges are structurally the same and have the-~same attachment positions- and orientation relative to the absorbent material bodies of the first, second, and third surgical sponges, the attachment position being proximate a corner of the absorbent material body defined by the intersection of the first edge and third edge, and the orientation being such that the elongated side of the RFID tag extends along the first edge (Eisenberg, Fig. 6, par. 47, 58: tags are at the same position relative to the sponges and can overlap each other but the tag may be inverted or rotated to avoid tag-tag interaction);
wherein the pack further includes packaging (band(s) 26) securing the surgical sponges in a stack including opposed first and second ends each defined by the top surface or the bottom surface of a different one of the surgical sponges, opposed first and second sides each intersecting the opposed first and second ends, and opposed third and fourth sides each intersecting the opposed first and second ends and the opposed first and second sides, the opposed third and fourth sides of the stack being defined by the opposed third and fourth edges of the surgical sponges, respectively,
wherein the first surgical sponge is positioned between the second and the third surgical sponges within the stack and is vertically flipped about the first edge of the first surgical sponge relative to the second and third surgical sponges such that the top surfaces including the RFID tags of the second and third surgical sponges face the first ends of the stack, the top surface including the RFID tag of the first surgical sponge faces the second end of the stack opposite the first end; the elongated sides of the RFID tags of the second and third surgical sponges each extends along the first side of the stack, and the elongated side of the RFID tag of the first surgical sponge extends along the second side of the stack that is opposite the first side of the stack (Eisenberg, par. 44-47: items can be positioned at different positions relative to each other and a tag’s position on an item is different than the next tag’s position; par. 56: alternating tag can be inverted or rotated; thus, it would have been obvious to one of ordinary skill in the art before the effective date the invention was made to extend Eisenberg’s teachings by inverting or flipping a first sponge that is between a second and third sponges to minimize tag-tag interaction),
positioning the obtained pack of surgical sponges in the sterile field and relative to the scanner positioned outside of the sterile field so that the first end of the stack is separated from and faces a plane defined by the antenna of the scanner (Fig. 8);
reading, with the scanner positioned outside of the sterile field, the unique identifiers stored on the RFID tag of all of the surgical sponges of the pack while the first ends of the stack is separated from and facing the plane of the scanner and the pack is positioned in the sterile field; adding the unique identifiers to an electronic record associated with the surgical procedure; (Stewart, par. 22, 50: “surgical articles will be programmed after having been assembled into the pack”; Eisenberg, Fig. 4, 7: the tags can face plane of reader antenna)
removing the surgical sponges from the packaging for use in the surgical procedure after the unique identifiers are added; positioning one of the surgical sponges relative to the scanner positioned outside of the sterile field following use of the one surgical sponge in the surgical procedure so that the one surgical sponge is separated from the scanner and positioned in the sterile field; reading, with the scanner positioned outside of the sterile field, the unique identifier stored on the RFID tag of the one surgical sponge while the surgical sponge is separated from the scanner and positioned in the sterile field following use in the surgical procedure; and updating the electronic record to indicate presence of the one surgical sponge after use in the surgical procedure based on the unique identifier read from the RFID tag of the one surgical sponge after use in the surgical procedure (Stewart, par. 71-73: after one sponge is removed from a sterile pack and used in a procedure, the used sponge is read by the reader to ensure all sponges are accounted for).
30.29, although not expressly stated, it would have been obvious that the pack is capable of being rotated and being read while being rotated since the reader can scan sponges placed in a pack, pile, or bucket and within the reader’s reading field (Stewart, Fig. 8, par. 72; Eisenberg, par. 50, 70, 80, 92)
Re claims 33-34, see discussion regarding claims above.
33.29, wherein the packaging comprises one or more straps bundling the surgical sponges.
34.29, wherein the RFID tag of each of a fourth and fifth of the surgical sponges is attached to the absorbent material body of the surgical sponge proximate the third edge and such that the elongated side of the RFID tag extends along the third edge of the surgical sponge, and
wherein the packaging secures the fourth and fifth surgical sponges in the stack with the first, second, and third surgical sponges, such that the fourth surgical sponge is disposed between the first and second surgical sponges, with the top surface including the RFID tag of the fourth surgical sponge facing the first end of the stack and the elongated side of the RFID tag of the fourth surgical sponge extending along the third side of the stack, and such that the fifth surgical sponge is disposed between the first and third surgical sponges, with the fifth surgical sponge being vertically flipped about the first edge relative to the fourth surgical sponge such that the top surface including the RFID tag of the fifth surgical sponge faces the second end of the stack opposite the first end of the stack and the elongated side of the RFID tag of the fifth surgical sponge extends along the third side of the stack.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stewart (US 20180285704, paragraphs and Figures cited herein are in the supporting provisional application 62/480965 filed 04/03/2017) /Eisenberg (US 20020196126) in view of Volpi (US 20080018432, previously provided)
Re claim 3.1, Stewart is silent to wherein each of the surgical sponges comprises a lead extending along the first edge of the absorbent material body of the surgical sponge to beyond the third edge of the absorbent material body at a position adjacent the RFID tag of the surgical sponge.
Volpi discloses [0243] Turning now to FIG. 71, illustrated is a diagram of a LAP sponge 7100 with an encapsulated RFID tag 7105. In this embodiment, attachment occurs by sewing (designated by a seam 7115) the RFID tag 7105 onto the sponge 7100 in the same area as a radiopaque object (e.g., radiopaque loop) 7120 is attached (Fig. 71-73, par. 237)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective date the invention was made to incorporate the teachings of Volpi for at least ease in recognition that the item being a surgical sponge by x-ray machines.
Claim(s) 5-6, 31-32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stewart (US 20180285704, paragraphs and Figures cited herein are in the supporting provisional application 62/480965 filed 04/03/2017) /Eisenberg (US 20020196126) in view of Stewart’674 (US 7703674) and Ackley (US 6,371,375)
Re claim 5.1, Stewart discloses US 7,703,674 and 7,795,491 teaching a package label can be scanned in order to upload the identification, type, and other information from the individual (par. 8). The package label is considered a master label comprising a scannable indicia. Stewart further discloses the total sponge number is encoded in the RFID labels (par. 50)
Stewart is silent to the master tag comprising an optically-scannable element indicating a number of surgical sponges contained in the pack, wherein the scanner includes an optical scanning device configured to read the optically-scannable element when the pack is positioned relative to the scanner.
Stewart’674 discloses “Referring now to FIG. 7, individual sponges or other articles 50 may be packaged in a common package 52, such as a plastic or other wrap. Each of the individual sponges or other articles 50 will have an individual label 54 including all of the identification numbers (e.g. serial number), type, and visual motif information discussed above. In addition, the package 52 may possess an additional label 56 having machine-readable information which includes most or all of the information from each and every label 54 on the individual sponges or other articles 50. In this way, the package label 56 can be scanned once in order to provide at least the identification, type, and visual motif information from the individual sponges or other articles 50 to the computer or other distal scanning system of the present invention. The individual labels 54 will be needed, of course, for scanning the individual sponges or other articles 50 as they are removed from the patient or if they have been unused in the procedure … Machine-readable information will usually be optically encoded, such as a bar code or a two-dimensional code, such as a Datamatrix.RTM. pattern, but could also be electronically, sonically, or otherwise interrogable and readable. For example, the identifying information could be in the form of a radio frequency identification tag (RFID) … The machine-readable information is usually provided by an optically readable label which is affixed directly to a surface of the sponge or other surgical article. Alternatively, the information could be provided by radiofrequency identification tags or other electronic or acoustic data storage devices incorporated in or on the article. The articles will optionally further include human readable information corresponding to all or at least a part of the machine-readable information on the article (c3: 5-11, c5: 35-55, c7: 13-28)
Ackley discloses a scanner 60 capable of reading both barcode symbol 14 and RF tag 10 (Fig. 1-6, c5-6: 39-67+)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective date the invention was made to incorporate the teachings of Stewart’674 and Ackley in order to provide on the packaging information regarding the sponges in an optically encoded label on the packaging capable of being ready by a known RFID-barcode combined reader since the barcode encodes limited required information such as total number of sponges, thereby making it economical.
6.5, wherein the master tag is disposed at the first end of the stack (Stewart’674, Fig. 7, c7: 7-28)
Re claim 31-32, see discussion regarding claims above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/THIEN T MAI/ Primary Examiner, Art Unit 2876
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