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 .
Election/Restrictions
Applicant’s election without traverse of Group II in the reply filed on July 10, 2026 is acknowledged.
Claims 34-39, 43, and new claims 52-67 encompass at least Group II.
Claim Rejections - 35 USC § 103
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.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 34-36, 39, 43, and 66 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fearnot et al. (US 2013/0267848, hereinafter “Fearnot”).
Regarding claim 34, Fearnot discloses the invention substantially as claimed including a medical dilator kit (Fig 2) for an ultrasound-guided tissue dissection (fully capable of being used for tissue dissection), the kit comprising:
a. a beveled-tip medical dilator (41) comprising (i) a conical frustum section (tapered tip forming bevel at distal end) formed in a distal portion of the dilator, (ii) a cylinder section (body portion of 41 extending proximally from beveled distal end) formed proximally to the conical frustum portion to abut the base thereof (Figs 2-3; para [0029]); and
b. a dilator-sheath (43) having an internal diameter greater than or equal to an external diameter of the dilator (41) (Figs 2-3; para [0029]), the sheath comprising a hyperechoic marker (45) having an acoustic impedance greater than that of an outer cylindrical surface portion of the dilator-sheath adjacent to the marker, at least a portion of the marker being proximally displaced from a distal end of the dilator-sheath and distally displaced from a proximal end of the dilator-sheath (Figs 2-3; para [0029]).
However, Fearnot fails to teach how much greater the acoustic impedance of the marker is compared to an outer cylindrical surface portion of the dilator-sheath adjacent to the marker. Fearnot teaches “the echogenic marker 45 provided by a separate element with any of the patterned features as discussed hereinabove for echogenic markers, or containing internal materials or features that have an acoustic impedance that significantly differs from the surrounding media so as to be discernible by ultrasonic imaging” (para [0030]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Fearnot such that the hyperechoic marker has an acoustic impedance at least twice that of an outer cylindrical surface portion of the dilator-sheath adjacent to the marker since Fearnot teaches having an acoustic impedance significantly different and greater than that of an outer cylindrical surface portion of the dilator-sheath adjacent to the marker so as to be discernible by ultrasonic imaging and since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Regarding claims 35-36, Fearnot teaches at least a portion of the hyperechoic marker (45) is displaced slightly from the distal end distal end of the dilator sheath (43) (Figs 2-3; para [0029]). However, Fearnot fails to disclose the particular distance from the distal end of the dilator sheath the marker may be placed. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Fearnot such that the hyperechoic marker was displaced 3-6 cm or 4-5cm from the distal end of the dilator sheath, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. Alternatively, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Fearnot by placing that the hyperechoic marker such that it was displaced 3-6 cm or 4-5cm from the distal end of the dilator sheath in order to position the marker to best view the distal end of the dilator sheath by ultrasound since Applicant has placed no criticality on the particular placement of the marker as evidenced by the broad range of disclosed distances (specification page 11, lines 2-9) and since modifying Fearnot to have the specified marker placement would not adversely affect the function of the device. The courts have recognized that where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimension would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device (Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984)).
Regarding claim 39, wherein the hyperechoic marker (45) is attached to the outer cylindrical surface portion of the dilator-sheath or formed in the outer cylindrical surface portion of the dilator-sheath (para [0030]).
Regarding claim 43, additionally comprising an inter-tissue or inter-organ spacer (filter 20 is fully capable of functioning as the claimed spacer; Figs 5-7; para [0039-0040]).
Regarding claim 66, Fearnot teaches the hyperechoic marker (45) is displaced a marker distance from the distal end of the dilator-sheath (43). However, Fearnot fails to teach wherein the marker distance is the same as the length of the inter-tissue or inter-organ spacer (20). Fearnot does teach additional markers spaced longitudinally from one another on different portions of the device to help with determining the positioning of the spacer (20) with respect to the sheath (43) (Para [0039-0040]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to try further modifying Fearnot such that the marker distance is the same as the length of the inter-tissue or inter-organ spacer for the purpose of visualizing the positioning between the spacer and sheath as a person with ordinary skill has good reason to pursue the known options within his or her technical grasp and since it is obvious to choose from a finite number of identified, predictable solutions with a reasonable expectation of success. Furthermore, it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8 and thus it alternatively would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add additional markers and try further modify Fearnot with additional markers such that the marker distance of at least one marker is the same as the length of the inter-tissue or inter-organ spacer for the purpose of visualizing the positioning between the spacer and sheath as a person with ordinary skill has good reason to pursue the known options within his or her technical grasp and since it is obvious to choose from a finite number of identified, predictable solutions with a reasonable expectation of success
Claim(s) 37-38 and 61-63 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fearnot (US 2013/0267848), as applied to claim 34 above, further in view of Flaherty et al. (US 6,746,426, hereinafter “Flaherty”).
Fearnot discloses the invention substantially as claimed, as shown above, including a beveled-tip medical dilator (41) and a dilator-sheath (43) (Figs 2-3; para [0029]). However, Fearnot does not disclose dilator-sheath includes a beveled circumference. Flaherty discloses a similar medical dilator kit comprising:
a. a beveled-tip medical dilator (111) (Figs 3B, 3D) comprising (i) a conical frustum section (118) formed in a distal portion of the dilator, (ii) a cylinder section (proximal portion 113 extending from distal portion 118) formed proximally to the conical frustum portion to abut the base thereof; and
b. a dilator-sheath (100) having an internal diameter greater than or equal to an external diameter of the dilator (111) (Figs 3A, 3D), the sheath comprising a marker (109), at least a portion of the marker being proximally displaced from a distal end of the dilator-sheath and distally displaced from a proximal end of the dilator-sheath (Fig 3D), wherein the distal-tip section of the dilator-sheath includes a beveled circumference (tip 110 of sheath; Figs 3B, 3D), wherein a beveling angle of the distal-tip (110) section of the dilator-sheath is greater than a slant angle of the conical frustrum section (118) of the dilator (Figs 3B, 3D), wherein the conical frustum section (118) of the beveled-tip dilator comprises the first beveled outer surface, wherein the distal end (110) of the dilator-sheath comprises the second beveled outer surface, and wherein the second beveled surface of the dilator-sheath serves to transition between the first beveled outer surface of the dilator and the outer cylindrical surface portion of the dilator- sheath (Fig 3D). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Fearnot such that the dilator-sheath (43) additionally comprised a bevel and the bevels of the dilator and dilator-sheath were appropriately angled, as taught by Flaherty, to smoothly transition between the outer diameter of the sheath to the outer diameter of the dilator in a minimally invasive manner. The modification allows for a gradual taper of the device and minimizes harm to the vasculature during insertion.
Claim(s) 52-54, 58-60, 64, and 67 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fearnot (US 2013/0267848), as applied to claim 34 above, further in view of Reeves (US 5,222,970, hereinafter “Reeves”).
Fearnot discloses the invention substantially as claimed, as shown above, including additionally comprising an inter-tissue or inter-organ spacer (filter 20 is fully capable of functioning as the claimed spacer; Figs 5-7; para [0039-0040]). However, Fearnot fails to disclose the inter-tissue or inter-organ spacer comprises an inflatable balloon. Reeves teaches a balloon kit (Figs 5-8) comprising an inflator (source of inflation material – col 3, ln 42-50), a medium (inflation material), an inflation tube (26) attached to the inflator, and a balloon (11) releasably attachable to the inflation tube (26), wherein the balloon kit is configured to be inserted through a sheath (27) and wherein the inflator is operable to inflate the balloon (col 5, ln 65 – col 6, ln 52). The inflation tube (26) has a length sufficient to allow a distal tip of the balloon (11) to be aligned with the distal end of the sheath (27) in a first state (Fig 6) and positioned distally with respect to the distal end of the sheath in a second state (Fig 7). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Fearnot such that the dilator sheath (43) was used for delivering a balloon kit, as taught by Reeves, in place of the filter (20). Substitution of one known element (balloon to treat the vasculature) for another element (filter to treat the vasculature) providing the same function to yield predictable results (treatment of the vasculature) would have been obvious to one of ordinary skill in the art at the time of the invention. The modification allows the sheath of Fearnot to be useful in additional procedures, including occluding the vasculature, as taught by Reeves.
Claim(s) 55-57 and 65 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fearnot (US 2013/0267848) and Reeves (US 5,222,970), as applied to claim 34 above, further in view of Shohat (US 2012/0330340, hereinafter “Shohat”). Fearnot and Reeves disclose the invention substantially as claimed, as shown above, including a balloon kit insertable through the dilator-sheath. Reeves teaches the balloon (11) may comprise a variety of inflation mediums, including “a liquid inflation material consisting of a solidifying polymer, contrast medium, or saline” (col 3, ln 42-50). However, Reeves fails to teach the balloon or spacer may comprise a gel as claimed. Shohat discloses a similar inflatable balloon (12) capable of functioning as a spacer and teaches the balloon “can be expanded by using gas, liquid or gel” (para [0239]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the combination of Fearnot and Reeves such that the spacer or balloon further comprised a gel since Reeves teaches a gel is a known functional equivalent for inflating or filling a balloon or spacer and substitution of one known element for another element providing the same function to yield predictable results would have been obvious to one of ordinary skill in the art at the time of the invention. Furthermore, it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Conclusion
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/KATHERINE M RODJOM/Primary Examiner, Art Unit 3771
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