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 . 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.
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 3 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 3 depends on a canceled claim and there is no antecedent basis for “the cutter,” rendering it indefinite.
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.
Claims 1, 3, 4, 10-12 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Henley (US 5,823,990) in view of Davison (US 2003/0097129).
Regarding claim 1, 3, 4, 10, 11 and 14, Henley discloses a device with a tube defining a lumen and having proximal and distal ends, a cap and a side aperture (fig. 8). The device also has a suction port connected to a suction source (not numbered, see element 20a in fig. 5) and a macerating structure aligned with the side aperture (81) with a drive rod (83) for rotating the macerating structure (col. 6 lines 53-63). The drive rod cooperates with the lumen to form an annular lumen for the aspiration of macerated tissue (fig. 8). There are no bushings between the suction port and side aperture, and the macerating structure is non-expandable, sized to closely match an inner contour of the distal end of the tube/cap (fig. 8, “closely” being interpreted as broad rather than indefinite). The side aperture can be considered to be formed by a single post which extends between the end of the tube and the cap. Regarding the language directed to a blood mass in the brain, 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, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited in the preamble, or elsewhere in a claim, then it meets the claim. Henley does not disclose the use of a cutter inside the tube protruding radially toward the rod proximal to the macerating structure. However, the use of additional tissue shredding mechanisms is fairly common in the art. Davison, for example, discloses a tissue removal device which uses cutters protruding radially toward the middle of a tube and set back proximal from an opening (1820, figs. 51A-B and 57A-B). Davison further teaches that the shape, arrangement, size and number of these electrodes is a matter of design choice ([0289]), where one of the embodiments shows the cutter is a wedge (figs. 57A-B). Therefore, at the time the application was filed, it would have been obvious to one of ordinary skill in the art to provide the device of Henley with cutters in any configuration as taught by Davison, including a wedge radially pointing toward the middle of the tube (where the rod is) and set back from the aperture (proximal to the macerating structure), that would produce the predictable result of ensuring tissue is sufficiently cut up to be removed by aspiration.
Regarding claim 12, Henley does not specifically disclose the dimensions of the side aperture. However, the device would have an aperture opening less than 180 degrees if the cross-section shown in figure 8 is mirrored. Even if the cross-section is not mirrored and the aperture extends farther on one side than the other, the range of possible aperture sizes would include sizes less than 180 degrees (see MPEP 2144.05(I) regarding the obviousness of similar or overlapping ranges). It is well within the level of ordinary skill in the art to select the size of an aperture based on the particular procedure or the particular tissue region being treated. Further, Applicant has not disclosed the claimed range is critical or produces an unexpected result (within the meaning of MPEP 716.02(a)). Therefore, at the time the application was filed, it would have been obvious to one of ordinary skill in the art to select any radial dimension for the aperture of Henley, including less than 180 degrees, which would produce the predictable result of a device having desired operating characteristics.
Claims 5-7 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Henley and Davison, further in view of Laufer (US 2005/0165345).
Regarding claims 5, 6 and 13, Henley discloses the macerating structure is a cage/wire whisk (fig. 8) but does not specifically show the distal contour is rounded to match a cap that has a rounded inner surface. However, a change of shape is an obvious modification (MPEP 2144.04(IV)(B)) and Applicant has not disclosed how the shape of the macerating structure/cap produces an unexpected result. Laufer discloses an electrosurgical device similar to Henley, including a tube with a macerating structure where the macerating structure is a cage/whisk with a rounded contour that generally matches the rounded shape of the cap (fig. 36B, 36C and 37B). The cap is thus understood to extend at least 135 degrees spherically around the distal contour of the macerating structure. Therefore, at the time the application was filed, it would have been obvious to one of ordinary skill in the art to modify the device of Henley to include a cage/whisk with a rounded shape that matches the rounded inner surface of a cap, as taught by Laufer, to produce the predictable result of allowing the device to macerate tissue in a desired manner.
Regarding claim 7, Henley shows that the aperture is occupied less than 50% by the whisk (fig. 8, only parts of two tines occupying the aperture).
Claims 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Henley, Davison and Laufer, further in view of Chang (US 2006/0004323).
Regarding claims 8 and 9, Henley as modified shows the elements as discussed above but does not disclose the macerating structure is a rounded square. However, a change of shape is an obvious modification (MPEP 2144.04(IV)(B)) and Applicant has not disclosed how the shape of the macerating structure/cap produces an unexpected result. Chang discloses a medical device with an element having a shape and teaches the shape can be any number of shapes including round and rounded square (figs. 5A-N, figs. 5C and 5H in particular). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to further modify the macerating structure and cap of Henley to have any commonly known shape, including rounded square as taught by Chang, that would produce the predictable result of a functional medical device.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Henley and Davison in view of Lee (US 2002/0095100).
Regarding claim 15, Henley does not disclose an ultrasound transducer disposed on the end of the tube. However, use of ultrasound transducers is very common in the art. Lee, for example, discloses what can be considered a generic surgical device and teaches that an ultrasound transducer (270, fig. 1A) is useful to ensure that the distal end of the device is in the proper location for treatment ([0097]). Therefore, at the time the application was filed, it would have been obvious to one of ordinary skill in the art to further modify device of Henley with an ultrasound transducer as taught by Lee to allow a user to image the tissue region to be treated.
Claims 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Henley and Davison, further in view of West (US 6,610,059) and Blomgren (US 2009/0281540).
Regarding claims 16 and 17, Henley does not disclose a pressure switch between two electrodes that are coupled to a power supply (the ablation electrodes can be considered a heating element). However, providing electrodes to mechanical cutters for spot treating tissue is common in the art. West, for example, discloses a mechanical cutting device in an aspiration lumen (figs. 5-6) that includes a plurality of electrodes (64) that are useful to allow an operator to perform other types of tissue treatments (col. 6 lines 35-60). Therefore, at the time the application was filed it would have been obvious to one of ordinary skill in the art to provide the device of Henley with a plurality of electrodes connected to a power supply as taught by West to allow the operator to deliver energy to tissue. West also does not disclose the use of a pressure switch between electrodes. However, it is clearly beneficial to only apply energy to tissue via the electrodes when there is actually tissue within range. Further, since a user would wait until the electrodes are touching tissue before applying energy to tissue, the use of a switch to perform that step can be considered the automation of a manual process (MPEP 2144.04(III)). Blomgren discloses an electrosurgical device (fig. 2A) which uses pressure switches (116-118) at least one of which is between (117) electrodes (104, 105). Blomgren teaches that the switches ensure that there is no gap between the electrodes and the tissue during energy delivery ([0045]). Therefore, at the time the application was filed it would have been obvious to further modify the device of Henley with a heating element in the form of electrodes as taught by West, and to include pressure sensors between the electrodes to ensure that the device is touching the tissue to be treated before energy is delivered as taught by Blomgren to produce the predictable result of automating the process of ensuring desirable contact between the electrode and tissue during energy delivery.
Response to Arguments
Applicant's arguments filed 04 February 2026 have been fully considered but they are not persuasive. The arguments do not account for the level of ordinary skill in the art and have an unclear relationship to the actual features disclosed by Davison. Applicant asserts that the cutter of Davison is one of a pair of bipolar electrodes, but Davison does not describe the electrodes as bipolar. Ablation electrodes, generally speaking, require an active and return electrode to function, but Davison’s cutting electrodes 1450 (figs. 42A-b, which can include a single cutter electrode, [0289]) are all described as being active ([0289]). It is possible the return electrode(s) are nearby, which is commonly called a bipolar configuration, or it is possible the return electrode(s) are farther off, which is commonly called a monopolar configuration. The fact that Davison does not even bother to show the return electrode(s) or describe the electrode configuration is evidence that a person of ordinary skill in the art would know how to make functional ablation electrodes, including at least one digestion electrode in a lumen proximal to an opening. Therefore, there is no evidence for Applicant’s assertion that the electrodes “must be immediately near each other.” As to the cutters being “proximal,” they are clearly shown proximal to the opening, and in fact they must be proximal to the opening to perform the digestion function described. Applicant’s assertion that the electrodes would interfere with Henley’s cage is unsupported. A person of ordinary skill in the art would not make a non-functioning device. Further, Davison does not describe any particular positioning of the cutters with respect to the opening (the drawings not being to scale) so there is no evidence that the cutters must necessarily be positioned in a manner that would be close enough to the opening of Henley that would overlap with the cage. There is also no evidence that it makes any difference to Davison where the digestion takes place along the lumen. Therefore, a person of ordinary skill in the art, being a person of ordinary creativity and not an automation (MPEP 2141.03(I)), would be able to place the cutters proximal to the cage to produce a functioning device. Applicant further asserts that moving one electrode proximal without moving the other would result in an undesirable situation. Again, none of the cutting electrodes 1450 are passive and even if 1450 represented pairs of bipolar electrodes there is no reason why a person of ordinary skill in the art would position the electrodes at a distance that would be non-functional. Applicant also states that “bringing both electrodes into the lumen would make them ineffective in ablating tissue outside the device.” It is not clear what the argument is here. There only needs to be one electrode in the lumen for digestion ([0289]), Davison does not care where the return electrode is located, and the electrode in the lumen is for digestion, not “ablating tissue outside the device.” Davison uses a different, independent electrode (1406, fig. 42A) for ablating tissue outside the device. Similarly, Applicant states that there is no motivation to move the digestion electrode “proximally until it is displaced from the aperture” but this is already the configuration shown by Davison. Therefore, the examiner maintains that there is a motivation to add an electrode to the inside of Henley’s lumen (to digest aspirated tissue) and that there is a motivation to move it proximally within the lumen until it does not interfere with the basket (to make a device that actually works).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL WAYNE FOWLER whose telephone number is (571)270-3201. The examiner can normally be reached Monday-Friday (9-5).
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/DANIEL W FOWLER/Primary Examiner, Art Unit 3794