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 .
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) 1-7 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Roux (US 20040225197) in view of Notrica (US 20110251540).
With respect to claims 1 and 11, Roux teaches a thoracic device (see fig. 2, 5a below below) comprising: a pair of sternal plates (16, 16), each sternal plate of the pair of sternal plates including a body having a first end and a second end (see fig. 5a below), a first arm (e.g., at 68) extending from the first end of the body, the first arm having an aperture (e.g., 70) oriented parallel to the body, and a second arm (e.g., 38) extending from the second end of the body (see fig. 5a below); and a bar (22) including a third end and a fourth end (see fig. 2, 5a below), wherein the third end of the bar is received within the cavity of one of the pair of sternal plates and the fourth end of the bar is received within the cavity of the other of the pair of sternal plates (see fig. 2, 5a below). Note that although only one sternal plate is annotated, the other sternal plate contains comparable elements.
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Roux does not appear to teach the first arm having a cavity oriented transverse to the body, the third end having a first channel extending through the bar and the fourth end having a second channel extending through the bar, and wherein, when the third end of the bar is received within the cavity, the first channel and the aperture are configured to axially align to receive a fastener therethrough; and wherein the cavity is disposed at a midpoint of the first arm.
Notrica, also drawn to thoracic devices (see abstract) teaches a mechanical connection between a bracket/plate arm (e.g., 20a) and a bar (12) with third and fourth ends (see fig. 1 and note ends of 12), the first arm having a cavity (e.g., 34) oriented transverse to the body (see fig. 4 below), the third end having a first channel (e.g., 18- see fig. 4 below) extending through the bar and the fourth end having a second channel (e.g., respective 18, see fig. 4 below and para. 24-25) extending through the bar, and wherein, when the third end of the bar is received within the cavity, the first channel and the aperture are configured to axially align to receive a fastener (36) therethrough (see para. 25); and wherein the cavity is disposed at a midpoint of the first arm (see fig. 4 below) in order to better secure the bar and plate together with a known mechanical connection (see para. 25).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Roux with the first arm having a cavity oriented transverse to the body, the third end having a first channel extending through the bar and the fourth end having a second channel extending through the bar, and wherein, when the third end of the bar is received within the cavity, the first channel and the aperture are configured to axially align to receive a fastener therethrough; and wherein the cavity is disposed at a midpoint of the first arm, in view of Notrica, in order to better secure the bar and plate together with a known mechanical connection.
As for claim 2, Roux, as modified by Notrica, further teaches the thoracic device of claim 1, further comprising a fastener (36) configured to couple the third end of the bar to the first arm of the one of the pair of sternal plates (see fig. 4 above).
As for claim 3, Roux, as modified by Notrica, further teaches the thoracic device of claim 2, wherein the fastener is configured to extend through the aperture of the first arm and the first channel of the bar (see fig. 5).
As for claim 4, Roux, as modified by Notrica, further teaches the thoracic device of claim 1, wherein the aperture of the first arm and the first channel of the bar are configured to axially overlap (see fig. 4 abve).
As for claims 5-7, Roux, as modified by Notrica, further teaches the thoracic device of claim 1, wherein the body defines a plane, wherein the first arm defines a plane, and wherein the plane of the first arm is oriented at a non-zero angle between 90 degrees and 110 degrees relative to the plane of the body (see fig. 5a below); wherein the bar defines a plane, and wherein the plane of the body and the plane of the bar are perpendicular (see fig. 5a below); wherein the body defines a plane, wherein the second arm defines a plane, and wherein the plane of the second arm is oriented at a non-zero angle between 90 degrees and 110 degrees relative to the plane of the body (see fig. 5a below and note that although only one plate is annotated, the other plate contains a comparable elements).
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Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Roux (US 20040225197) and Notrica (US 20110251540), as applied to claim 1 above, in view of Matsumura (WO2011099553A1).
As for claim 8, Roux, as modified by Notrica, does not appear to teach wherein the bar includes a length defined between the third end of the bar and the fourth end of the bar, and wherein the length is between 37 millimeter and 160 millimeters.
Matsmura, also drawn to sternal retractors, teaches wherein the bar includes a length defined between the third end of the bar and the fourth end of the bar, and wherein the length is between 37 millimeter and 160 millimeters (see Description below) in order to best accommodate the size of the patient (see Description below).
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It would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Roux, as modified by Notrica, wherein the bar includes a length defined between the third end of the bar and the fourth end of the bar, and wherein the length is between 37 millimeter and 160 millimeters, in view of Matsmura, in order to best accommodate the size of the patient.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Roux (US 20040225197) and Notrica (US 20110251540), as applied to claim 1 above, in view of Sauer (US 20190307442).
As for claim 9, Roux, as modified by Notrica, does not appear to teach wherein the bar includes an indicator displaying a distance between a first sternum edge of a patient and a second sternum edge of a patient.
Sauer, also drawn to cardiac surgical tools and devices, teaches the addition of a unique identifier (including a color, text label, image, pattern, a size and a shape) on a device in order to allow a surgeon to quickly identify a specific device from a plurality of devices (see claim 11).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Roux, as modified by Notrica, wherein the bar includes an indicator displaying a distance between a first sternum edge of a patient and a second sternum edge of a patient (i.e., the size of the bar), in view of Sauer, as a matter of engineering design choice, in order to allow a surgeon to quickly identify a specific device from a plurality of devices.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Roux (US 20040225197) and Notrica (US 20110251540), as applied to claim 1 above, in view of Butterfield (CA-3081187-A1).
As for claim 10, Roux, as modified by Notrica, does not teach wherein the pair of sternal plates and the bar are comprised of a glass reinforced polymer.
Butterfield, also drawn to medical retractors (see abstract), teaches wherein the retractor is comprised of a glass reinforced polymer (e.g., polyarylamide- see page 9, last paragraph, page 10, first paragraph, page 14 paragraph 2) in order to provide an easy to manufacture retractor that will not obstruct the surgical site (see page 10 last paragraph).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Roux, as modified by Notrica, wherein the pair of sternal plates and the bar are comprised of a glass reinforced polymer, in view of Butterfield, in order to provide an easy to manufacture retractor that will not obstruct the surgical site.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Roux (US 20040225197) and Notrica (US 20110251540), as applied to claim 1 above, in view of Haarstad (US 7338434).
As for claim 12, Roux, as modified by Notrica, does not teach wherein the second arm includes a transducer configured to generate and sense ultrasound energy.
Haarstad, also drawn to cardiac surgical devices, teaches incorporation of a transducer (e.g., 50) configured to generate and sense ultrasound energy (see col. 28 lines 28-35, 58-63) in order to provide the surgeon with the desired treatment implement at the surgical site (see col. 28 lines 58-63).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Roux, as modified by Notrica, wherein the second arm includes a transducer configured to generate and sense ultrasound energy, in view of Haarstad, in order to provide the surgeon with the desired treatment implement at the surgical site.
Claim(s) 13-15, 18 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Roux (US 20040225197) in view of Notrica (US 20110251540) and in further view of Lee (WO2005016131A2).
With respect to claims 13-15, 18 and 19, Roux teaches a first pair of sternal plates (see fig. 2, 5a above), each of the first pair of sternal plates including a body having a first end and a second end (see fig. 2, 5a above), the body having a first length (see fig. 2, 5a above), a first arm (68) extending from the first end of the body (see fig. 5a above), the first arm having an aperture (70) oriented parallel to the body (see fig. 5a above), and a second arm extending from the second end of the body (see fig. 5a above); a bar including a third end and a fourth end (see fig. 5a above), wherein the third end of the bar is received within the cavity of one of the first pair of sternal plates and the fourth end of the bar is received within the cavity of the other of the first pair of sternal plates (see fig. 2 above); wherein the first arm and the second arm of the first pair of sternal plates define a first clearance (e.g. distal end) configured to receive a sternum edge of a patient (see fig. 2, 5a above); wherein each sternal plate of the first pair of sternal plates includes a first plane defined by the body (see fig. 5a above, claims 5-7 above), a second plane defined by the second arm (see fig. 5a above, claims 5-7 above), wherein the second plane is oriented at a non-zero angle between 90 degrees and 110 degrees relative to the first plane (see fig. 5a above, claims 5-7 above); and wherein each sternal plate of the first pair of sternal plates includes a third plane defined by the first arm (e.g., at thickness), wherein the third plane is oriented at a non-zero angle between 90 degrees and 110 degrees relative to the first plane (see fig. 2, 5a above).
Roux does not appear to teach the first arm having a cavity oriented transverse to the body, the third end having a first channel extending through the bar and the fourth end having a second channel extending through the bar, and wherein, when the third end of the bar is received within the cavity, the first channel and the aperture are configured to axially align to receive a fastener therethrough.
Notrica, also drawn to thoracic devices (see abstract) teaches a mechanical connection between a bracket/plate arm (e.g., 20a) and a bar (12) with third and fourth ends (see fig. 1 and note ends of 12), the first arm having a cavity (e.g., 34) oriented transverse to the body (see fig. 4 above), the third end having a first channel (e.g., 18- see fig. 4 above) extending through the bar and the fourth end having a second channel (e.g., respective 18, see fig. 4 above and para. 24-25) extending through the bar, and wherein, when the third end of the bar is received within the cavity, the first channel and the aperture are configured to axially align to receive a fastener (36) therethrough (see para. 25) in order to better secure the bar and plate together with a known mechanical connection (see para. 25).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Roux with the first arm having a cavity oriented transverse to the body, the third end having a first channel extending through the bar and the fourth end having a second channel extending through the bar, and wherein, when the third end of the bar is received within the cavity, the first channel and the aperture are configured to axially align to receive a fastener therethrough, in view of Notrica, in order to better secure the bar and plate together with a known mechanical connection.
Roux, as modified by Notrica, does not teach a kit including a plurality of bars, each bar having a different length, a second pair of sternal plates, each of the second pair of sternal plates including a body having a first end and a second end, the body having a second length different than the first length of the body of the first pair of sternal plates, a first arm extending from the first end of the body, the first arm having a cavity oriented transverse to the body and an aperture oriented parallel to the body, and a second arm extending from the second end of the body; wherein the first arm and the second arm of the second pair of sternal plates define a second clearance configured to receive a sternum edge of a patient, and wherein the first clearance is greater than the second clearance.
Lee, also drawn to retractors (see abstract), teaches a kit including a variety of interchangeable components, including different sized components (see para. 8), in order to accommodate different patients as is well known in the field (see para. 8).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Roux, as modified by Notrica, to include a kit with a plurality of bars, each bar having a different length, a second pair of sternal plates, each of the second pair of sternal plates including a body having a first end and a second end, the body having a second length different than the first length of the body of the first pair of sternal plates, a first arm extending from the first end of the body, the first arm having a cavity oriented transverse to the body and an aperture oriented parallel to the body, and a second arm extending from the second end of the body; wherein the first arm and the second arm of the second pair of sternal plates define a second clearance configured to receive a sternum edge of a patient, and wherein the first clearance is greater than the second clearance, in view of Lee, in order to accommodate different patients as is well known in the field.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Roux (US 20040225197), Notrica (US 20110251540) and Lee (WO2005016131A2), as applied to claim 13 above, in view of Matsumura (WO2011099553A1).
As for claim 17, Roux, as modified by Notrica, does not appear to teach wherein the bar includes a length defined between the third end of the bar and the fourth end of the bar, and wherein the length is between 37 millimeter and 160 millimeters.
Matsmura, also drawn to sternal retractors, teaches wherein the bar includes a length defined between the third end of the bar and the fourth end of the bar, and wherein the length is between 37 millimeter and 160 millimeters (see Description above, claim 8) in order to best accommodate the size of the patient (see Description above, claim 8).
It would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Roux, as modified by Notrica, wherein the bar includes a length defined between the third end of the bar and the fourth end of the bar, and wherein the length is between 37 millimeter and 160 millimeters, in view of Matsmura, in order to best accommodate the size of the patient.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Roux (US 20040225197), Notrica (US 20110251540) and Lee (WO2005016131A2), as applied to claim 13 above, in view of Haarstad (US 7338434).
As for claim 20, Roux, as modified by Notrica, does not teach wherein the second arm includes a transducer configured to generate and sense ultrasound energy.
Haarstad, also drawn to cardiac surgical devices, teaches incorporation of a transducer (e.g., 50) configured to generate and sense ultrasound energy (see col. 28 lines 28-35, 58-63) in order to provide the surgeon with the desired treatment implement at the surgical site (see col. 28 lines 58-63).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Roux, as modified by Notrica, wherein the second arm includes a transducer configured to generate and sense ultrasound energy, in view of Haarstad, in order to provide the surgeon with the desired treatment implement at the surgical site.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: US 20150327847.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Tara Carter whose telephone number is (571) 272-3402. The examiner can normally be reached on M-F 7am-3pm.
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If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Eduardo Robert, at (571) 272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TARA ROSE E CARTER/ Examiner, Art Unit 3773
/EDUARDO C ROBERT/ Supervisory Patent Examiner, Art Unit 3773