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 .
Response to amendments
Claims were amended 10/27/25.
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 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stevens et al. [US Pat. 5797960, hereinafter “Stevens”] in view of Bachman [US 2004/0044365 A1] and Brustad et al. [US 2004/0230119 A1, hereinafter “Brustad”].
Re. claim 1, Stevens discloses a medical device shaft [Figs 27-28, with details shown in Fig. 2A] comprising:
a rigid, elongate shaft [24, Fig. 2 and 27; rigid, Col. 13 line 12] defining a primary working lumen [30; that through which the needle extends] that runs a length of the elongate shaft and is distally open at a distal end of the elongate shaft, the primary working lumen having a needle [274, Fig. 27] disposed therein;
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an end effector form [Annotated Fig. 27] coupled to a distal end of the elongate shaft [Figs. 2A], the end effector form including a circumferential flange [32] projecting radially outwardly at a distal end of the elongate shaft [Fig. 27].
Stevens discloses ultrasonically imaging the patient and the device [Col. 7 lines 24-28] but fails to teach an echogenic element associated with the end effector form. However, Bachman teaches, in a medical device with a shaft [14] and end effector form [16, Fig. 1], an echogenic element are associated with within the end effector form [“the elongated body 14, the engagement tip 16, or both may incorporate radio-opaque or echogenic materials,” Par. 0031]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of Stevens by forming the end effector form to have the echogenic additives embedded within it, in addition to those in the shaft, as taught by Bachman, because this further enables the surgeon to precisely position the tip within the patient’s body [Bachman Par. 0031].
Regarding the plurality of echogenicity-enhancing lumens, Stevens is silent. However, Brustad teaches, in a shaft of a medical device [Figs. 1-2],
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a plurality of echogenicity-enhancing lumens [115 and 140, Fig. 2] formed in the elongate shaft and arranged in a distributed circumferential arrangement around the primary working lumen [110], each of the plurality of echogenicity-enhancing lumens running along a respective straight path along the length of the elongate shaft [Fig. 1] and containing echogenicity- enhancing fluid therein [“air trapped in closed lumen 115 provides strong reflection of ultrasound energy,” Par. 0021, and “third lumen 140 [also] entrap[s] air and further enhance[s] ultrasonic imaging,” Par. 0022].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of Stevens by adding the plurality of echogenicity-enhancing lumens as taught by Brustad in order to facilitate ultrasonic reflection along the shaft to further improve/increase visibility of the shaft within the body [Brustad, Pars. 0021-0022]
Claim(s) 2-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stevens in view of Bachman and Brustad as applied to claim 1 and further in view of Massengale et al. [US 20120095404 A1, hereinafter “Massengale”]
Re. claim 2, Stevens discloses the medical device shaft above but fails to teach the echogenic element being a plurality of metal wire loops. However, Massengale teaches a medical device shaft wherein one or more echogenic elements comprises a plurality of metal wire loops [252 and 254] attached on a proximal side of the end effector form, the wire loops projecting radially away from the elongate shaft [Fig. 20]. Massengale teaches that these wire loops are elements which are “frequently manufactured” with catheters, so forming them to be echogenic merely requires a modification of bands or rings [Par. 0079] and thus is a simple way of making the distal region echogenic. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of the modified Stevens by forming the echogenic elements to have the structure taught by Massengale in order to allow for an easily modified part to easily become echogenic.
Re. claim 3, Massengale further teaches the one or more echogenic elements comprises a metal annular disc lying in a plane perpendicular to an axis of the elongate shaft, the metal annular disc having a central aperture that is coaxial with the axis of the elongate shaft [Figs. 19-20]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of the modified Stevens to include the discs as taught by Massengale for the reason set forth with respect to claim 2 above.
Claim(s) 4-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stevens in view of Bachman, Brustad and Massengale as applied to claim 3 and further in view of Malecki et al. [US 2006/0074410 A1, hereinafter “Malecki”].
Re. claim 4, the modified Stevens teaches the apparatus set forth above, including the metal annular disc embedded within the end effector form [taught by Massengale as set forth above and/or modifying Stevens by Massengale in the claimed manner for the reasons set forth above] but fails to teach the end effector being tapered such that a diameter increases toward a distalmost portion. However, Malecki teaches a medical device shaft wherein the metal annular disc is embedded within the end effector form, the end effector form having a distally outwardly tapered shape, such that a diameter of the end effector form increases moving towards a distal-most portion of the end effector form [Fig. 2C]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of the modified Stevens by forming the device to have the shape taught by Malecki because this configuration allows the device to perform functions associated with treating defects such as patent foramen ovale [Malecki, Abstract].
Re. claim 5, Malecki further teaches an annular metal disc is disposed at the distal-most portion of the end effector form [disc 1213, Fig. 2C]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of the modified Stevens such that the disc is disposed at the distal most portion as taught by Malecki in order to accurately visualize the end of the device.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stevens in view of Bachman, Brustad as applied to claim 1 and further in view of Field [US 2010/0256577 A1]
Re. claim 8, the modified Stevens teaches the apparatus set forth above, but fails to teach the extruded sleeve.
However, Field teaches, in a medical device, the end effector form is a unitary form with a sleeve that is slidingly disposed over the elongate shaft [Annotated Fig. 1/Par. 0016]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of the modified Stevens such that the end effector is in unitary form with a sliding sleeve as taught by Field in order to allow the end effector and shaft to be moved relative to each other.
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Regarding the sleeve being extruded, Field teaches other parts being extruded [Par. 0016], and It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of the modified Stevens such that the sleeve is extruded because this amounts to selecting one from a limited list of options for manufacturing the sleeve. Furthermore, this product-by-process claim only limits the apparatus insofar as it limits the structure of the sleeve. It is not clear how an extruded sleeve would be structurally different from a sleeve produced by another method.
Regarding the circumferential flange being a unitary form with an extruded sleeve, given the above teachings, forming the flange to be a unitary form would have been an obvious modification in order to reduce the number of manufacturing steps.
Claim(s) 9 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stevens in view of Brustad.
Re. claim 9, Stevens as modified by Brustad teaches the medical device shaft with echogenicity-enhancing lumens substantially as set forth with respect to claim 1 above. Brustad teaches the lumens being distally closed [closed at both ends, in order to entrap air; see Pars. 0021-0022] and it would have been obvious to close the echogenicity-enhancing lumens in order to allow them to operate as intended.
Re. claim 11, Brustad and Stevens both disclose the primary working lumen having a circular cross-sectional shape. Furthermore, Brustad teaches that “lumen 115… may have any cross-sectional shape.” Therefore, forming the plurality of echogenicity-enhancing lumens to have a non-circular cross-sectional shape amounts to selecting one type of shape (non-circular) from a limited list of options (circular or non-circular) with predictable results.
Claim(s) 10 and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stevens in view of Brustad, or Stevens in view of Bachman and Brustad, and further in view of.
Re. claims 10 and 23, the modified Stevens discloses the apparatus set forth above. Both Stevens and Brustad disclose/teach the primary working lumen being a central circular lumen [see figs. cited with respect to claim 1 above]. Brustad further teaches the plurality of echogenicity-enhancing lumens consisting of first and second lumens circumferentially disposed about opposite sides of the central circular lumen, the plurality of echogenicity-enhancing lumens are closed at the distal end of the elongate shaft around the open primary working lumen [see Brustad Fig. 2 and Pars. 0021-0022]. Brustad further teaches that “lumen 115… may have any cross-sectional shape” but fails to disclose specific shapes other than circular. However, forming the lumen to have arcuate shapes amounts to a design choice which does not impact the functioning of the device.
Regarding the first and second lumens being arcuate and separated by a pair of bifurcating septa extending radially inward from an outer wall of the elongate shaft and terminating at a periphery of the central working lumen: forming the first and second lumens to be arcuate would, given their nature of being spaced symmetrically about the circumference, result in them being separated by a pair of bifurcating septa extending radially inward from an outer wall of the elongate shaft and terminating at a periphery of the central working lumen. Therefore, the above-modified Stevens would reasonably convey to one of ordinary skill the advantage of the apparatus having lumens and septa as claimed.
Response to Arguments
Applicant’s arguments have been considered but are moot. Although the same references are cited herein, the examiner agrees that the references as previously applied fail to read on the newly amended claims, and a different embodiment of Brustad is used to teach the newly amended claim features.
ConclusionApplicant'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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/ERIN MCGRATH/Primary Examiner, Art Unit 3771